吉利德科學 (GILD) 2023 Q4 法說會逐字稿

Good afternoon. Thank you for attending the Fourth Quarter and Full Year 2023 Gilead Sciences Earnings Conference Call. My name is Victoria, and I'll be your moderator today.

午安.感謝各位參加吉利德科學公司2023年第四季及全年財報電話會議。我是主持人維多利亞。

(Operator Instructions) I would now like to pass the conference over to your host, Jacquie Ross. Thank you. You may proceed, Jacquie.

（操作員指示）現在我將會議交給主持人傑奎·羅斯。謝謝。杰奎，您可以開始了。

Thank you, operator, and good afternoon, everyone.

謝謝接線員，大家下午好。

Just after market close today, we issued a press release with earnings results for the fourth quarter and full year of 2023. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com.

今天收盤後不久，我們發布了新聞稿，公佈了2023年第四季和全年的獲利情況。新聞稿、投影片和補充資料可在我們網站gilead.com的投資人關係欄位中查閱。

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 Cindy Perettie, the Executive Vice President of Kite.

今天電話會議的發言人包括：董事長兼首席執行官丹尼爾·奧戴 (Daniel O'Day)；首席商務官喬安娜·默西埃 (Johanna Mercier)；首席醫療官默達德·帕西 (Merdad Parsey)；以及首席財務官安德魯·迪金森 (Andrew Dickinson)。之後，我們將進入問答環節，屆時Kite執行副總裁辛迪佩雷蒂 (Cindy Perettie) 也將加入討論。

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 2024 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.

在開始之前，請允許我提醒各位，我們將做出一些前瞻性聲明，包括與吉利德的業務、財務狀況和經營業績、產品計劃和預期、候選產品、公司策略、業務和營運、財務預測和資本使用以及 2024 年財務指引相關的聲明。所有這些都涉及某些我們無法控制的假設、風險和不確定性，這些因素可能導致實際結果與這些聲明有重大差異。

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. 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.

這些風險的描述可在獲利新聞稿和我們最新的美國證券交易委員會（SEC）揭露文件中找到。所有前瞻性陳述均基於吉利德目前可獲得的信息，吉利德不承擔更新任何此類前瞻性陳述的義務。我們將使用非GAAP財務指標來幫助您了解公司的基本業務表現。 GAAP與非GAAP的調節表可在盈利新聞稿、補充資料表以及吉利德網站上找到。

With that, I'll turn the call over to Dan.

接下來，我會把電話交給丹。

Thank you, Jacquie, and good afternoon, everyone. The team and I are pleased you could join us today as we share the details of our full year and fourth quarter performance and the latest on our clinical portfolio.

謝謝Jacquie，大家下午好。我和我的團隊很高興今天能與大家一起分享我們全年和第四季度的業績詳情，以及我們臨床產品組合的最新進展。

Starting with our full year performance, 2023 was a strong year for Gilead, with 7% growth in product sales, excluding Veklury, driven by HIV and Oncology. HIV grew by almost $1 billion, with Biktarvy sales growing 14% to almost $12 billion, and increasing its market share in the U.S. to 48%. Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just 1 year. This growth was split evenly between our Kite cell therapies and Trodelvy. Veklury for COVID-19 contributed $2.2 billion in 2023, ahead of our expectations, but down year-over-year as expected, given the evolution of the pandemic.

從全年業績來看，2023年對吉利德而言是強勁的一年，除Veklury外，產品銷售額成長了7%，主要得益於HIV和腫瘤領域的成長。 HIV業務成長近10億美元，其中Biktarvy的銷售額成長14%，達到近120億美元，在美國的市佔率也提升至48%。腫瘤業務成長37%，達到近30億美元，光是一年就成長了近8億美元。這一增長主要由Kite細胞療法和Trodelvy貢獻。 Veklury用於治療COVID-19，2023年貢獻了22億美元的銷售額，高於預期，但如預期，由於疫情的發展，其年銷售額有所下降。

In the last 2 years combined, Gilead's base business has grown approximately $3.3 billion or more than 7% annually, largely offsetting the decline in Veklury revenues over the same period. The consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst-rich phase for Gilead with more than 20 updates this year and many more to come beyond 2024.

過去兩年，吉利德的基礎業務累計成長約33億美元，年均成長率超過7%，基本上抵銷了同期Veklury營收的下滑。基礎業務的持續成長為我們邁入2024年奠定了堅實的基礎，並協助我們實現廣泛的臨床產品組合。對吉利德而言，這是一個充滿機會的階段，今年已發布超過20項更新，2024年後還會有更多更新發布。

Starting with Oncology. We expect at least 12 further updates by the end of 2024. These include Phase III updates for Trodelvy in bladder and triple-negative breast cancer, and results from the pivotal Phase II iMMagine-1 study for anito-cel in multiple myeloma, for which we saw encouraging Phase I data at the American Society of Hematology meeting in December. Also in cell therapy, we are very pleased to have shortened our manufacturing time for Yescarta by another 2 days in the U.S., reinforcing our industry-leading median turnaround time which is now at an anticipated 14 days.

首先是腫瘤領域。我們預計到2024年底至少會有12項更新。其中包括Trodelvy治療膀胱癌和三陰性乳癌的III期臨床試驗更新，以及anito-cel治療多發性骨髓瘤的關鍵性II期臨床試驗iMMagine-1的結果。我們在12月舉行的美國血液學會年會上發表了anito-cel令人鼓舞的I期臨床試驗數據。此外，在細胞療法方面，我們非常高興地宣布，Yescarta在美國的生產週期又縮短了2天，進一步鞏固了我們行業領先的中位週轉時間，目前預計為14天。

As you know, we did not reach the primary endpoint for EVOKE-01, our Phase III trial for second-line plus metastatic non-small cell lung cancer. Merdad will go into detail on this later, but while we did not see the outcome we hoped for, the data are encouraging on a number of levels, namely: a numerical improvement in overall survival favoring Trodelvy, including in both squamous and non-squamous tumors; a safety profile consistent with our product label that could continue to differentiate Trodelvy versus other Trop-2 ADCs; and while not statistically powered, a potential benefit for a prespecified subpopulation that saw more than 3 months median overall improvement.

如您所知，我們針對二線及以上轉移性非小細胞肺癌患者的III期臨床試驗EVOKE-01並未達主要終點。 Merdad稍後將對此進行詳細闡述。儘管我們未能獲得預期結果，但數據在多個方面令人鼓舞，具體而言：Trodelvy組患者的總生存期在數值上有所改善，包括鱗狀細胞癌和非鱗狀細胞癌；安全性與產品說明書一致，這可能使Trodelvy繼續與其他Trop-2抗體偶聯藥物（ADC）區分開來；以及雖然Trodelvy

The team is evaluating next steps given the data and the significant unmet need, and we look forward to discussing the data with regulators. Based on the totality of the results in both EVOKE-02 and EVOKE-01, we are confident in Trodelvy's potential in patients with metastatic non-small cell lung cancer, including in earlier lines of therapy.

鑑於現有數據和龐大的未滿足醫療需求，團隊正在評估下一步措施，並期待與監管機構討論相關數據。基於EVOKE-02和EVOKE-01兩項研究的全部結果，我們對Trodelvy在轉移性非小細胞肺癌患者中的應用潛力充滿信心，包括用於早期治療。

In Virology, we are looking forward to a very important year for our HIV portfolio. among the multiple updates we are expecting are the Phase III data for lenacapavir in HIV prevention, and at least 8 updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic, building on Gilead's decades of leadership in HIV.

在病毒學領域，我們期待今年對我們的愛滋病產品組合而言意義非凡。我們預計將迎來多項更新，其中包括用於預防愛滋病的lenacapavir的III期臨床試驗數據，以及至少8項來自我們愛滋病治療計畫的最新進展。這些里程碑式的成果將使我們離終結愛滋流行的目標更近一步，並鞏固吉利德在愛滋病領域數十年的領先地位。

In COVID-19, today, we are announcing that our Phase III trial, Oaktree, evaluating obeldesivir did not meet its primary endpoint. We conducted the study to explore whether obeldesivir could address the public health need that existed with COVID-19 for standard risk patients. Again, Merdad will share details later.

今天，我們宣布，針對新冠肺炎的奧貝地西韋（obeldesivir）的III期臨床試驗「橡樹」（Oaktree）未能達到其主要終點。我們進行這項研究的目的是探討奧貝地西韋能否滿足新冠肺炎普通風險患者的公共衛生需求。稍後，Merdad將公佈更多細節。

But essentially, because of the way things have evolved, the standard risk population is now better able to fight COVID-19 without antiviral therapy. This made it more difficult for obeldesivir to show a benefit compared to placebo.

但本質上，由於疫情發展，一般人群現在無需抗病毒治療也能更好地抵抗新冠病毒感染。這使得奧貝地西韋與安慰劑相比更難顯示出療效。

We know that the world needs to be equipped for other viruses, and the broad antiviral activity of obeldesivir shown preclinically means it has potential for other viral infections. The updates we are expecting in 2024 have the potential to unlock multiple opportunities across virology and oncology. With a broad portfolio where the risk is balanced, we look forward to following the science and continuing to make a positive impact for patients and communities.

我們深知世界需要做好應對其他病毒的準備，而臨床前研究已證實奧貝地西韋具有廣泛的抗病毒活性，這意味著它對其他病毒感染也具有潛在療效。我們預計在2024年獲得的最新進展可望在病毒學和腫瘤學領域開啟許多機會。憑藉風險平衡的廣泛產品組合，我們期待遵循科學發展，繼續為患者和社區帶來積極影響。

Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.

吉利德設定了一個雄心勃勃的目標，到 2030 年推出至少 10 種變革性療法，我們正充滿信心地朝著這個目標邁進。

Before I hand over to the team for their updates, I'll move to Slide 6 and recap that we executed well in 2023 and achieved all the remaining targeted goals that we expected to in the fourth quarter. We'll share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for Gilead.

在將報告交給團隊報告之前，我將轉到第6張投影片，回顧我們在2023年的執行情況，並實現了第四季度所有剩餘的預期目標。我們將在稍後的演示中分享2024年的重要里程碑，但很明顯，對於吉利德來說，這將是非常忙碌的一年。

I'd like to thank the teams for their work in bringing us to this important catalyst-rich phase for the company and for the strong commercial performance that gives us a firm foundation on which to build.

我要感謝各個團隊的努力，正是他們的付出才使公司進入了這一重要的、充滿催化劑的階段，並且取得了強勁的商業業績，為我們未來的發展奠定了堅實的基礎。

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

這樣，我就把它交給喬安娜了。

Thanks, Dan, and good afternoon, everyone.

謝謝你，丹，大家下午好。

Beginning on Slide 8. Total product sales for the full year were at the high end of our guidance range at $26.9 billion, reflecting solid base business growth with total product sales, excluding Veklury, up 7% year-over-year to $24.7 billion. This was almost entirely offset by the expected decline in Veklury sales.

從第8張投影片開始。全年產品總銷售額達到我們預期範圍的高端，為269億美元，這反映了穩健的業務成長。若不計入Veklury，產品總銷售額年增7%，達到247億美元。這一增長幾乎完全被Veklury銷售額的預期下滑所抵消。

For the full year, Veklury sales were $2.2 billion, reflecting the uptick in hospitalizations at the end of 2023, though still below levels seen in 2022.

2023 年全年，Veklury 的銷售額為 22 億美元，反映了 2023 年底住院人數的上升，但仍低於 2022 年的水準。

Turning to the fourth quarter on Slide 9. Total product sales were $7.1 billion, down 4% year-over-year. Our base business sales were roughly flat year-over-year at $6.3 billion, primarily driven by higher oncology sales offset by lower HIV sales due to changes in channel mix that resulted in lower average realized price, in addition to the expected decline of our portfolio of non-promoted products.

請參閱投影片9，以了解第四季的情況。產品總銷售額為71億美元，較去年同期下降4%。我們的基礎業務銷售額與去年同期基本持平，為63億美元，這主要得益於腫瘤產品銷售額的增長，但部分被HIV產品銷售額的下降所抵消，HIV產品銷售額下降是由於渠道組合的變化導致平均實際售價降低，此外，非推廣產品組合的預期下滑也是原因之一。

Moving to Slide 10. Our HIV business delivered very strong results for the full year, up 6% year-over-year to $18.2 billion and contributing almost $1 billion in base business growth, primarily driven by demand as well as higher average realized price due to channel mix and inventory dynamics.

切換到第 10 張投影片。我們的 HIV 業務全年業績非常強勁，年增 6% 至 182 億美元，貢獻了近 10 億美元的基礎業務成長，這主要得益於需求以及通路組合和庫存動態帶來的更高平均實現價格。

More specifically, almost half of the full year HIV growth was driven by higher demand most notably by Biktarvy, which delivered solid double-digit year-over-year growth of 14%, with annualized revenues now more than $12 billion. Already the clear market leader, Biktarvy continues to demonstrate impressive share gains, growing almost 3% year-over-year in the fourth quarter of 2023, to approximately 48% share in the U.S. This growth once again outpaced all other branded regimens for HIV treatment and represented the 22nd quarter of consecutive year-over-year share gain.

更具體地說，全年HIV市場成長近一半是由需求增加推動的，其中最顯著的是Biktarvy，其同比增長14%，實現了兩位數的穩健增長，年化收入現已超過120億美元。身為市場領頭羊，Biktarvy持續保持令人矚目的市佔率成長勢頭，在2023年第四季年增近3%，在美國的市佔率達到約48%。這一增長再次超過了所有其他品牌HIV治療方案，並實現了連續第22個季度的市場份額同比增長。

For the fourth quarter, as highlighted on Slide 11, HIV sales of $4.7 billion reflected strong demand in line with our expectations. On a year-over-year basis, this was offset by lower average realized price due to channel mix that was notably favorable in the fourth quarter of 2022 and resulted in a decline of 2%. Sequentially, sales were up 1%, similarly driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix.

如投影片11所示，第四季HIV產品銷售額達47億美元，反映了強勁的需求，符合我們的預期。與去年同期相比，由於通路組合的顯著優勢，平均實際售價下降了2%，部分抵消了這一成長。環比來看，銷售額成長了1%，同樣得益於強勁的需求和有利的庫存動態，但部分被通路組合導致的平均實際售價下降所抵消。

As we have noted previously, the pricing tailwinds we saw in the second half of 2022 and the first half of 2023 are not expected to repeat, and will make year-over-year comparisons more challenging in the immediate term as we saw in the fourth quarter.

正如我們之前指出的，我們在 2022 年下半年和 2023 年上半年看到的定價利好因素預計不會重現，這將使短期內同比比較更具挑戰性，正如我們在第四季度看到的那樣。

As a reminder, quarterly HIV growth is, in general, significantly more variable and less indicative of overall trends than the full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.

需要提醒的是，季度 HIV 感染人數的成長通常比全年成長波動更大，更不能反映整體趨勢，尤其是一些季度定價和庫存動態往往會在一年中逐漸趨於正常化。

Factors include: first, gross-to-net adjustments, which can be difficult to forecast due to the lag between product sales and claim payments that frequently occur in different quarters; second, the timing of bulk government purchases, which contribute to overall demand, but can have a significant negative impact on pricing in the quarter in which they occur. For example, certain discounted government segments are unpredictable in terms of bulk order timing, and this impacts overall average realized price.

影響因素包括：首先是毛利淨利調整，由於產品銷售和理賠支付之間存在滯後，且通常發生在不同的季度，因此難以預測；其次是政府批量採購的時間安排，雖然政府批量採購會推高整體需求，但會對採購當季的價格產生顯著的負面影響。例如，某些政府折扣產品的大量訂單時間難以預測，這會影響整體平均成交價格。

And then finally, the inventory build by subchannel wholesalers and customers that typically occurs towards the end of the year. Historically, this happens in the fourth quarter. In 2023, we saw the build start in the third quarter and continue, albeit to a lesser extent relative to prior years into the fourth quarter.

最後，還有次級通路批發商和客戶通常在年底進行的庫存累積。歷史上，這種情況發生在第四季。但在2023年，我們發現庫存累積從第三季度就開始了，並持續到第四季度，儘管與往年相比規模有所縮小。

Overall, despite these quarterly variables, we remain confident that overall demand trends are strong and unchanged. With our HIV treatment market share above 70% in the U.S. and above 40% in PrEP, Gilead remains well positioned to continue delivering demand-driven growth.

總體而言，儘管存在這些季度性波動，我們仍然對整體需求趨勢保持強勁且穩定充滿信心。吉利德在美國的愛滋病治療市佔率超過70%，在暴露前預防（PrEP）領域的市佔率超過40%，這使我們能夠持續維持需求驅動型成長。

For 2024, we expect HIV sales to grow approximately 4%, reflecting annual treatment demand growth of 2% to 3%, Biktarvy market share gains and continued double-digit growth in demand for HIV prevention.

預計 2024 年 HIV 銷售額將增長約 4%，這反映了每年 2% 至 3% 的治療需求增長、Biktarvy 市場份額的提升以及 HIV 預防需求的持續兩位數增長。

In terms of quarterly HIV revenue, keep in mind that the first quarter is always impacted by the reset of patient co-pays and deductibles. Additionally, we've historically seen inventory buildup in the fourth quarter that has led to notable drawdowns by wholesalers in the first quarter.

就季度愛滋病相關收入而言，需要注意的是，第一季總是會受到病患自付額和免賠額重置的影響。此外，我們歷來都看到第四季庫存積壓，這會導致批發商在第一季大幅減少庫存。

In the first quarter of 2023, this contributed to HIV sales declining 12% sequentially, and we expect a similar decline in the 10% to 12% range for the first quarter of 2024. The continued strong performance to both Biktarvy and Descovy for PrEP are shown on Slide 12.

2023年第一季，這導致HIV產品銷售額較上季下降12%，我們預期2024年第一季也將出現類似的10%至12%的降幅。第12頁幻燈片顯示了Biktarvy和Descovy在暴露前預防（PrEP）領域持續強勁的銷售表現。

Overall, Gilead's leadership in HIV is unmatched, with a solid commercial portfolio and robust pipeline of potentially best-in-class regimens to serve the daily oral, long-acting oral and long-acting injectable markets. And I can share that we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.

整體而言，吉利德在愛滋病領域的領先地位無可匹敵，擁有強大的商業產品組合和強大的研發管線，其中包含眾多有望成為同類最佳的治療方案，可滿足每日口服、長效口服和長效注射劑市場的需求。我可以透露，我們在愛滋病需求方面開局強勁，這使我們對2024年全年的預期充滿信心。

Moving to the liver disease portfolio on Slide 13. Sales of $2.8 billion for the full year highlight the consistently strong and stable contribution from our liver disease portfolio.

接下來，我們來看看第 13 張投影片中的肝病產品組合。全年銷售額達 28 億美元，凸顯了我們肝病產品組合持續強勁且穩定的貢獻。

In the fourth quarter, sales were $691 million, flat year-over-year and down 2% sequentially, primarily driven by unfavorable pricing dynamics, offset by higher HCV market share and our efforts to increase linkage to care, in addition to growing HDV demand in new and existing European geographies.

第四季銷售額為 6.91 億美元，與去年同期持平，環比下降 2%，主要受不利的價格動態影響，但被更高的 HCV 市場份額和我們為加強與護理的聯繫所做的努力所抵消，此外，歐洲新老地區對 HDV 的需求也在增長。

In HCV, we continue to reinforce Gilead's leadership with market share of over 60% in the U.S. and over 50% in Europe. While we continue to expect the rate of HCV new starts to trend downwards over time, given the curative nature of our medicines, demand growth in both HDV and HBV is largely offsetting that headwind.

在C型肝炎領域，吉利德持續鞏固其市場領先地位，在美國的市佔率超過60%，在歐洲的市佔率超過50%。儘管我們預計丙型肝炎新發病例數將隨著時間的推移而下降，但鑑於我們藥物的治癒特性，丁型肝炎和乙型肝炎的需求增長在很大程度上抵消了這一不利因素。

On to Slide 14. Veklury sales continue to be highly variable, with the fourth quarter down 28% year-over-year, though up 13% sequentially due to higher COVID-related hospitalizations in the fourth quarter. For the full year, Veklury sales of $2.2 billion exceeded the expectations we set out at the beginning of 2023.

接下來是第14張投影片。 Veklury的銷售額依然波動較大，第四季年減28%，但由於第四季新冠肺炎相關住院人數增加，季增13%。全年來看，Veklury的銷售額為22億美元，超過了我們在2023年初設定的預期。

Turning to Slide 15. Our oncology business has achieved an annualized run rate that now exceeds $3 billion, with strong fourth quarter sales of $765 million, up 24% year-over-year. In just 3 years, Trodelvy revenue has grown to more than $1 billion, and we continue to see strong growth across our approved indications. And in cell therapy, sales approached $2 billion in 2023, and Kite remains firmly established as the leading provider of CAR T-cell therapies globally.

請翻到第15頁投影片。我們的腫瘤業務年化收入已超過30億美元，第四季銷售額強勁成長至7.65億美元，較去年同期成長24%。短短三年內，Trodelvy的營收已成長至10億美元以上，我們在所有已核准的適應症領域均持續保持強勁成長。在細胞療法領域，2023年銷售額接近20億美元，Kite仍穩居全球CAR-T細胞療法領先供應商的地位。

Looking more closely at Trodelvy on Slide 16. Sales for the full year were $1.1 billion, up 56% year-over-year. For the fourth quarter, sales were $299 million, up 53% year-over-year and 5% sequentially.

仔細看一下投影片16中Trodelvy的業績。全年銷售額為11億美元，較去年同期成長56%。第四季銷售額為2.99億美元，年增53%，季增5%。

With over 30,000 patients treated to date, Trodelvy's solid demand trends continue to reinforce its robust clinical profile as the only Trop-2 directed antibody drug conjugate, approved and available in multiple tumor types. Awareness and utilization continue to increase, driving notable share gains.

迄今為止，已有超過3萬名患者接受了Trodelvy的治療，其強勁的需求趨勢持續鞏固了其作為唯一獲批並可用於多種腫瘤類型的Trop-2靶向抗體藥物偶聯物的優勢。該藥物的認知度和使用率持續提升，推動了市場份額的顯著增長。

In second-line metastatic triple-negative breast cancer, approximately 1/3 of patients are receiving Trodelvy, reinforcing its position as the leading regimen across the U.S. and other major markets.

在二線轉移性三陰性乳癌治療中，約有 1/3 的患者正在接受 Trodelvy 治療，這鞏固了其在美國和其他主要市場作為領先治療方案的地位。

In pretreated HR-positive HER2-negative metastatic breast cancer, we're encouraged to see share growth overall, driven by increasing adoption in the IHC-0 setting as well as continued use in HER2-low. Additionally, we look forward to potentially making Trodelvy more broadly available in metastatic bladder cancer. Data from the confirmatory Phase III TROPiCS-04 study in the first half of the year would enable global filings and subsequent launches as well as potentially drive adoption in the U.S., altogether, expanding Trodelvy's potential reach to nearly 25,000 second-line plus patients with metastatic bladder cancer.

在先前接受過治療的HR陽性HER2陰性轉移性乳癌患者中，我們很高興地看到整體市場份額增長，這主要得益於IHC-0患者群體中Trodelvy應用率的提高以及HER2低表達患者的持續使用。此外，我們期待Trodelvy能夠更廣泛地應用於轉移性膀胱癌的治療。今年上半年即將公佈的III期確證性研究TROPiCS-04的數據將有助於Trodelvy在全球範圍內的上市申請和後續推廣，並有望推動其在美國的普及，最終使Trodelvy惠及近25,000名二線及以上轉移性膀胱癌患者。

Turning to Slide 17 and on behalf of Cindy and the Kite team, cell therapy sales were $1.9 billion in 2023, grew 28% from 2022, driven by impressive growth, particularly outside the U.S. as we expanded our network of authorized treatment centers and secured reimbursement following recent approvals.

翻到第 17 張幻燈片，我代表 Cindy 和 Kite 團隊表示，2023 年細胞療法銷售額為 19 億美元，比 2022 年增長了 28%，這主要得益於令人矚目的增長，尤其是在美國以外，因為我們擴大了授權治療中心的網絡，並在最近的批准後獲得了報銷。

In the fourth quarter, cell therapy product sales were $466 million, up 11% year-over-year and down 4% sequentially, with strong growth in both Yescarta and Tecartus in Europe and other international markets, offset in part by near-term headwinds for Yescarta in the U.S., both in-class and out-of-class competition.

第四季度，細胞療法產品銷售額為 4.66 億美元，較去年同期成長 11%，較上季下降 4%。 Yescarta 和 Tecartus 在歐洲和其他國際市場都實現了強勁增長，但 Yescarta 在美國市場近期面臨不利因素，包括同類產品和非同類產品的競爭，部分抵消了上述增長。

As previously discussed, CAR T class share of eligible second line plus large B-cell lymphoma patients remains at roughly 15% in the U.S., as growth continues to be slower than anticipated despite the compelling clinical data that suggests these therapies are potentially transformative for many patients. In Europe and other markets, CAR T class share in this same second-line plus setting continues to be stronger at approximately 30%.

如前所述，在美國，CAR-T療法在符合條件的二線及以上大B細胞淋巴瘤患者中的佔比仍然約為15%，儘管有令人信服的臨床數據表明這些療法可能對許多患者帶來變革性影響，但其增長速度仍低於預期。在歐洲和其他市場，CAR-T療法在二線及以上治療的佔比則更高，約為30%。

Following a restructuring in November, the Kite team has been focused on extending the reach of cell therapies from primarily academic medical centers to community practices, especially in the U.S.

自 11 月重組以來，Kite 團隊一直致力於將細胞療法的覆蓋範圍從主要學術醫療中心擴展到社區診所，尤其是在美國。

In late 2023, we established partnerships with leading community networks, which include over 1,750 physicians nationally. We are certifying affiliated practices to become authorized treatment centers to provide Kite cell therapies.

2023年底，我們與領先的社區網絡建立了合作關係，這些網絡涵蓋全國超過1750名醫生。我們正在認證附屬診所，使其成為提供Kite細胞療法的授權治療中心。

So far, we've made notable headway across centers in the Southeast United States, for example, that operate over 40 locations to serve cancer patients. We expect to see the initial impact of these initiatives in mid-2024. In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023.

迄今為止，我們在美國東南部的多個中心取得了顯著進展，例如，這些中心經營著40多個服務點，為癌症患者提供服務。我們預計這些措施的初步成效將於2024年中期顯現。同時，我們預計2024年第一季細胞療法業務將與2023年第四季持平或略有成長。

Importantly, alongside our 96% reliability rate, we're also thrilled to share that we have shortened our manufacturing time in the U.S. by 2 days for Yescarta, bringing our anticipated median turnaround time to 14 days. This further extends our industry leadership in terms of manufacturing and the Kite team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.

值得一提的是，除了96%的可靠性之外，我們也欣喜地宣布，Yescarta在美國的生產週期縮短了2天，預計平均週轉時間縮短至14天。這進一步鞏固了我們在生產製造領域的行業領先地位，Kite團隊將繼續在細胞治療業務的這一關鍵環節進行創新。我們期待在本季稍後的分析師和投資者活動中，邀請您參觀我們的生產設施。

In conclusion, I'd like to thank our teams for a strong 2023 performance and setting up such great momentum for continued growth in 2024. The team is excited to continue to make our medicines accessible to all those who can benefit from them.

最後，我要感謝我們的團隊在2023年取得的優異成績，並為2024年的持續成長奠定了良好的基礎。團隊很高興能夠繼續努力，讓所有能從中受益的人都能獲得我們的藥品。

And with that, I'll hand over the call to Merdad.

好了，接下來我將把電話交給梅爾達德。

Thank you, Johanna. We've had a busy start to 2024, and I'll begin by discussing the results of our EVOKE-01 study in second line plus metastatic non-small cell lung cancer and our Phase III Oaktree study of obeldesivir in standard-risk, nonhospitalized patients with COVID-19.

謝謝 Johanna。 2024 年開始時我們非常忙碌，首先我想談談我們針對二線及以上轉移性非小細胞肺癌患者的 EVOKE-01 研究結果，以及我們針對標準風險、非住院 COVID-19 患者的 obeldesivir III 期 Oaktree 研究結果。

While we are disappointed that these studies did not meet their primary end points, we're also encouraged by what we are learning from the data to inform our clinical programs and support our commitment to deliver innovative new therapies for patients. Let me cover each of these readouts in turn.

儘管我們對這些研究未能達到主要終點感到失望，但我們也從數據中汲取了寶貴的經驗，這些經驗將指導我們的臨床項目，並支持我們致力於為患者提供創新療法的承諾。下面我將逐一介紹這些研究結果。

First, on Slide 19, our Phase III study of Trodelvy in second-line plus metastatic non-small cell lung cancer, EVOKE-01, missed its primary endpoint of overall survival in this hard-to-treat setting. We plan to share the detailed data at the earliest opportunity. In the meantime, we'd like to highlight what we believe to be an important set of observations from EVOKE-01 that give us continued confidence in Trodelvy as a pipeline-in-a-product, and its potential to benefit some patients with lung cancer.

首先，在第19張投影片中，我們針對二線及以上轉移性非小細胞肺癌患者所進行的Trodelvy III期研究EVOKE-01未能達到其主要終點－總存活期。我們計劃盡快公佈詳細數據。同時，我們想重點介紹EVOKE-01研究中我們認為重要的觀察結果，這些結果讓我們對Trodelvy作為在研產品及其潛在獲益於部分肺癌患者的前景充滿信心。

We saw a numerical improvement favoring Trodelvy, including in patients with both squamous and non-squamous histologies. This is encouraging for our ongoing Phase III EVOKE-03 first-line trial evaluating Trodelvy in PD-L1 high patients in combination with pembrolizumab.

我們觀察到，在包括鱗狀細胞癌和非鱗狀細胞癌在內的所有組織學類型的患者中，Trodelvy 的療效均有所改善。這對於我們正在進行的 III 期 EVOKE-03 一線治療試驗來說是一個令人鼓舞的結果，該試驗旨在評估 Trodelvy 聯合帕博利珠單抗治療 PD-L1 高表達患者的療效。

Importantly, Trodelvy continues to demonstrate a potentially differentiated safety, efficacy and tolerability profile, with an adverse event profile that is consistent with our label.

重要的是，Trodelvy 繼續展現出潛在的差異化安全性、有效性和耐受性，其不良事件特徵與我們的標籤一致。

Further, Trodelvy achieved more than 3 months of improvement in median overall survival in a prespecified subgroup of patients nonresponsive to their prior anti-PD-L1 therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I/O therapy and represented more than 60% of the trial population. This analysis was not alpha-controlled for formal statistical testing, and we are continuing to analyze these data. We will discuss these data with regulators and KOLs to determine the best path forward.

此外，在預先設定的、對既往抗PD-L1療法無反應的患者亞組中，Trodelvy使中位總存活期延長了3個月以上。此亞組定義為既往最後一次免疫腫瘤治療後最佳療效為疾病穩定或疾病進展的患者，佔試驗族群的60%以上。該分析未進行α校正以進行正式的統計檢驗，我們仍在繼續分析這些數據。我們將與監管機構和關鍵意見領袖討論這些數據，以確定最佳的後續方案。

As a reminder, we required all patients to have received prior I/O therapy regardless of driver mutation status and responsiveness to prior I/O was a stratification factor. Additional analyses, including Trop-2 expression, are ongoing, and we will share these data as quickly as possible.

再次提醒，我們要求所有患者無論驅動基因突變狀態如何，都必須接受過免疫檢查點抑制劑（I/O）治療，並且對既往I/O治療的反應是分層因素之一。我們正在進行包括Trop-2表達在內的其他分析，並將盡快分享這些數據。

Based on these observations and the data from the ongoing EVOKE-02 study, we remain confident in Trodelvy's potential in patients with metastatic non-small cell lung cancer. For now, given these findings, we currently do not plan changes to our Phase III EVOKE-03 study that's enrolling as expected.

基於這些觀察結果以及正在進行的 EVOKE-02 研究的數據，我們仍然對 Trodelvy 在轉移性非小細胞肺癌患者中的治療潛力充滿信心。目前，鑑於這些發現，我們暫不計劃對正在按預期招募患者的 III 期 EVOKE-03 研究進行任何更改。

Moving to Slide 20. Our novel, twice-daily, oral antiviral, obeldesivir, did not demonstrate statistically significant symptom relief in standard risk, nonhospitalized patients with COVID-19 in our Phase III Oaktree trial. Obeldesivir was well tolerated in this large study population, and we will share the data at a future medical meeting.

切換到第20張投影片。我們研發的新型口服抗病毒藥物奧貝地西韋（每日兩次給藥）在我們的III期Oaktree試驗中，並未在標準風險的非住院COVID-19患者中顯示出具有統計學意義的症狀緩解效果。奧貝地西韋在該大型研究族群中耐受性良好，我們將在未來的醫學會議上分享相關數據。

Overall, the Oaktree results reflect the decreasing severity and duration of COVID-19 symptoms observed in standard-risk patients, driven by the evolution of variants and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated, standard risk patients is now less than a week as compared to almost 2 weeks at the peak of the pandemic.

總體而言，Oaktree 的研究結果反映了標準風險患者 COVID-19 症狀嚴重程度和持續時間的降低，這主要歸因於病毒變異株的演變以及試驗人群對 COVID-19 免疫力的增強。未經治療的標準風險患者症狀緩解的時間現在不到一周，而疫情高峰期則接近兩週。

As a result, it was challenging for obeldesivir to show a benefit in the standard risk population. We continue to assess whether obeldesivir could address other viral infections, given the broad antiviral activity that we have observed in preclinical data.

因此，奧貝地西韋在標準風險族群中難以顯示出療效。鑑於我們在臨床前數據中觀察到的廣泛抗病毒活性，我們將繼續評估奧貝地西韋是否能夠治療其他病毒感染。

Moving to another clinical update in oncology, the Phase III ENHANCE-3 trial, evaluating magrolimab in front-line unfit AML has been discontinued based on a futility analysis and a higher observed incidence of Grade 5 serious adverse events. Following the discontinuation of ENHANCE and ENHANCE-2 last year, we do not plan further development of magrolimab in hematologic cancers.

在腫瘤學領域，另一項臨床進展是，評估magrolimab一線治療不適合接受其他治療的急性髓系白血病（AML）患者的III期ENHANCE-3試驗已因療效不佳和觀察到較高的5級嚴重不良事件發生率而終止。繼去年ENHANCE和ENHANCE-2試驗終止後，我們目前沒有計劃進一步開發magrolimab在血液腫瘤領域的應用。

Wrapping up on clinical updates, I want to thank all of those who were involved with EVOKE-01, Oaktree and ENHANCE-3. Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans. We look forward to sharing more on that in due course.

臨床進展報告即將結束，我要感謝所有參與 EVOKE-01、Oaktree 和 ENHANCE-3 計畫的人員。每一項試驗都為我們理解這些疾病的治療增添了重要的進展，並將指導我們未來的研發計劃。我們期待在適當的時候與大家分享更多相關資訊。

Transitioning to our HIV program on Slide 21, we expect the Phase III readout of PURPOSE 1, evaluating lenacapavir for HIV prevention later this year. Along with PURPOSE 2 expected in late 2024 or early 2025, PURPOSE 1 forms the basis of our potential regulatory filing. We continue to target our first approval for lenacapavir in prevention in late 2025, potentially making lenacapavir the first twice-yearly dosing regimen available for PrEP.

在第21張投影片中，我們將介紹我們的HIV專案。我們預計今年稍後公佈PURPOSE 1研究的III期結果，該研究旨在評估lenacapavir用於HIV預防的效果。 PURPOSE 1研究的結果，連同預計於2024年底或2025年初公佈的PURPOSE 2研究，將構成我們潛在監管申報的基礎。我們仍致力於在2025年底前獲得lenacapavir用於預防的首個批准，屆時lenacapavir有望成為第一個可用於PrEP的每年兩次給藥方案。

Looking at our HIV program more broadly, you can see we will be sharing at least 9 updates this year across our next-generation, daily, weekly, 3 monthly and twice yearly programs, all based on lenacapavir, our novel, first-in-class, long-acting capsid inhibitor.

從更廣泛的角度來看我們的 HIV 項目，您可以看到，今年我們將在下一代、每日、每週、每三個月和每年兩次的項目中分享至少 9 個更新，所有這些更新都基於我們新型的、同類首創的長效衣殼抑製劑 lenacapavir。

We're excited to have over 75 presentations at CROI this year, across Gilead-led and supported studies. Among them, some notable updates from our treatment pipeline include: encouraging data from our Phase II ARTISTRY-1 trial, evaluating our lenacapavir and bictegravir once daily oral. We're exploring this combination as a potential additional option for virologically suppressed people living with HIV; Phase I data on GS-1720, our once-weekly oral integrase inhibitor; and Phase II data on lenacapavir plus islatravir, our once-weekly oral combination in development with Merck. In the second half of this year, we look forward to providing an update on the Phase II trial evaluating lenacapavir plus bNAbs as a twice yearly regimen.

我們很高興今年能在CROI大會上發表超過75篇報告，涵蓋吉利德主導與支持的研究計畫。其中，我們治療產品線的一些重要進展包括：我們評估每日一次口服lenacapavir和bictegravir的II期ARTISTRY-1試驗的令人鼓舞的數據。我們正在探索這種聯合療法作為病毒學抑制的HIV感染者的潛在補充治療方案；我們每週一次口服整合酶抑製劑GS-1720的I期數據；以及我們與默克合作開發的每週一次口服lenacapavir聯合islatravir的II期數據。今年下半年，我們期待公佈評估lenacapavir聯合廣譜中和抗體（bNAbs）作為每年兩次治療方案的II期試驗的最新進展。

Turning to cell therapy on Slide 22. You may have seen that the FDA recently proposed safety label changes for all approved CD19 and BCMA CAR T-cell therapies, including Yescarta and Tecartus. There is no change to our confidence in the benefit risk profile of Yescarta and Tecartus.

接下來我們來看第22張投影片中的細胞療法部分。您可能已經注意到，FDA最近提議修改所有已批准的CD19和BCMA CAR-T細胞療法（包括Yescarta和Tecartus）的安全標籤。我們對Yescarta和Tecartus的獲益風險比的信心沒有改變。

Based on analysis of our global safety database, with over 16,800 patients treated with Yescarta, there has been no causal link established between Yescarta and those reported to the FDA public safety dashboard. Additionally, no cases of T-cell malignancies have been reported with Tecartus.

根據我們對全球安全資料庫的分析，在超過16,800名接受Yescarta治療的患者中，尚未發現Yescarta與FDA公共安全資訊平台報告的病例之間存在因果關係。此外，也未報告使用Tecartus治療後出現T細胞惡性腫瘤的病例。

In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December, showing that Yescarta and Tecartus continue to generate some of the longest follow-up and most robust data sets for cell therapies with the potential to transform patient lives.

去年第四季度，我們在 12 月舉行的美國血液學會會議上發表了 26 篇摘要，表明 Yescarta 和 Tecartus 繼續為細胞療法生成一些最長的隨訪和最可靠的數據集，這些療法有可能改變患者的生活。

Also at ASH, our partner, Arcellx, presented impressive updated data from the Phase I trial evaluating anito-cel in 38 patients with relapsed or refractory multiple myeloma. At a median follow-up of 26.5 months, median progression-free survival was not yet reached, despite 70% of patients having one or more high-risk prognosis factors.

在ASH大會上，我們的合作夥伴Arcellx公司也公佈了其I期臨床試驗的最新數據，該試驗評估了anito-cel在38名復發或難治性多發性骨髓瘤患者中的療效。中位追蹤時間為26.5個月，儘管70%的患者俱有一項或多項高風險預後因素，但中位無惡化存活期尚未達到。

Given this potentially differentiated safety profile with notably no delayed neurotoxicity to date, including Parkinsonism, anito-cel has the potential to become the best-in-class BCMA CAR T. We look forward to sharing an update from the pivotal Phase II iMMagine-1 study and initiating an earlier line multiple myeloma trial later this year.

鑑於其潛在的差異化安全性，迄今尚未發現任何遲發性神經毒性（包括帕金森氏症），anito-cel 有望成為同類最佳的 BCMA CAR-T 療法。我們期待分享關鍵性 II 期 iMMagine-1 研究的最新進展，並於今年稍後啟動一項針對早期多發性骨髓瘤的試驗。

In terms of manufacturing, while Kite is already the clear leader, we're pleased to highlight that the FDA approved our updated process that reduces the turnaround time for Yescarta in the U.S. from 16 days down to 14 days. This further extends our leadership in cell therapy and we continue to identify additional opportunities to reliably bring these much-needed therapies to more patients as quickly as possible.

在生產製造方面，儘管Kite已是行業領先者，但我們很高興地宣布，FDA已批准我們更新的工藝流程，將Yescarta在美國的生產週期從16天縮短至14天。這進一步鞏固了我們在細胞療法領域的領先地位，我們將繼續尋找更多機會，以可靠的方式盡快將這些亟需的療法帶給更多患者。

Beyond manufacturing, we have 8 ongoing cell therapy trials, of which 4 are evaluating new indications and 4 are exploring earlier lines of therapy.

除了生產製造之外，我們還有 8 項正在進行的細胞療法試驗，其中 4 項正在評估新的適應症，4 項正在探索更早期的療法。

As we formally wrap up 2023, on Slide 23, I would like to acknowledge the work of our clinical teams who executed on our ambitious and broad portfolio that extends far beyond the list shown, including the advancement of 8 new assets into the clinic, the delivery of 15 late-breaking oral presentations at major clinical congresses and the initiation of 3 new Phase III programs.

在正式結束 2023 年之際，在第 23 張幻燈片中，我想感謝我們的臨床團隊，他們執行了我們雄心勃勃且範圍廣泛的產品組合，遠遠超出了所示列表，包括將 8 個新資產推進到臨床階段，在主要臨床大會上發表了 15 場最新口頭報告，以及啟動了 3 個新的 III 期項目。

For 2024, our targeted milestones laid out on Slide 24 include: an update on ASCENT-03 in first-line PD-L1 negative metastatic triple-negative breast cancer, an update on TROPiCS-04, assessing overall survival in second-line metastatic or locally advanced bladder cancer, and an update on our Phase III PURPOSE 1 trial assessing lenacapavir in HIV prevention as previously highlighted.

2024 年，我們在投影片 24 中列出的目標里程碑包括：更新 ASCENT-03 在一線 PD-L1 陰性轉移性三陰性乳癌中的應用；更新 TROPiCS-04 的研究，評估二線轉移性或局部晚期膀胱癌的總生存期；以及更新我們之前重點介紹的評估 lenacapa III 期在 HIV 預防試驗中應用的 1 月 1 月。

We are also looking forward to the start of Phase III trials for Trodelvy in endometrial cancer, and the ARTISTRY trials evaluating lenacapavir and bictegravir oral combination for HIV treatment. Our commitment to develop innovative new therapeutic options is unchanged and we are confident that we will make progress on that commitment in 2024.

我們也期待Trodelvy治療子宮內膜癌的III期臨床試驗啟動，以及ARTISTRY試驗評估lenacapavir和bictegravir口服合併療法治療HIV感染的療效。我們致力於開發創新療法的承諾始終不變，並有信心在2024年實現這一目標。

And now I hand the call over to Andy.

現在我把電話交給安迪。

Thank you, Merdad, and good afternoon, everyone.

謝謝你，梅爾達德，大家下午好。

Starting on Slide 26. We closed the year with total product sales of $26.9 billion, at the top end of our guidance range due to a strong contribution from Veklury.

從第 26 頁開始。由於 Veklury 的強勁貢獻，我們全年產品總銷售額達到 269 億美元，達到我們預期範圍的上限。

For the full year, total product sales, excluding Veklury, grew 7%, driven by growth in both HIV and oncology. HIV increased 6% year-over-year, driven by Biktarvy which grew 14% from 2022 to $11.8 billion, and oncology grew to $2.9 billion for the full year, an increase of $792 million or 37% from 2022.

全年來看，不包括Veklury在內，產品總銷售額成長了7%，主要得益於HIV和腫瘤領域的成長。 HIV領域年增6%，主要由Biktarvy推動，其銷售額較2022年增長14%，達118億美元；腫瘤領域全年銷售額增長至29億美元，較2022年增長7.92億美元，增幅達37%。

Altogether, total product sales, excluding Veklury, were $24.7 billion, modestly below the lower end of our full year guidance range, largely due to quarterly pricing variability in HIV in the fourth quarter.

總的來說，不包括 Veklury 在內的產品總銷售額為 247 億美元，略低於我們全年指引範圍的下限，這主要是由於第四季度 HIV 藥物的季度定價波動所致。

Importantly, HIV volumes were in line with our expectations, and we are confident in our full year revenue growth expectations for HIV in 2024.

重要的是，HIV 銷售符合我們的預期，我們對 2024 年 HIV 的全年收入成長預期充滿信心。

Veklury revenue of $2.2 billion exceeded our guidance of approximately $1.9 billion, and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022, full year Veklury revenue declined as expected and represented a headwind of more than $1.7 billion to total product sales. This was largely offset by almost $1.7 billion in growth from our base business, resulting in roughly flat total product sales year-over-year.

Veklury 的營收達到 22 億美元，超過了我們先前約 19 億美元的預期，這反映了 2023 年下半年住院率的上升。與 2022 年相比，Veklury 的全年營收如預期下降，對產品總銷售額造成了超過 17 億美元的負面影響。不過，我們基礎業務近 17 億美元的成長基本上抵消了這一影響，最終使產品總銷售額與上年基本持平。

On Slide 27, our non-GAAP results were largely as expected, including gross margin and operating expenses, notably R&D, which showed disciplined moderation as we progressed through 2023. Non-GAAP EPS was $6.72 and within our guidance range despite the incremental $0.10 of acquired IPR&D associated with the Arcellx and Compugen partnerships that we announced following our guidance revision in November of 2023.

在第 27 頁投影片中，我們的非 GAAP 業績基本上符合預期，包括毛利率和營運費用，特別是研發費用，隨著我們進入 2023 年，研發費用呈現穩健的節製成長。儘管我們在 2023 年 11 月修訂業績指引後宣布了與 Arcellx 和 Compugen 合作相關的收購知識產權和研發費用增加了 0.10 美元，但非 GAAP 每股收益仍為 6.72 美元，並在我們的指引範圍內。

A quick note that our GAAP results were impacted by some restructuring expenses primarily related to our manufacturing strategy and our activities at Kite. And as we discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023 or $0.40 per share and contributed to GAAP EPS of $4.40 (sic) [$4.50] for the full year.

需要特別說明的是，我們的GAAP業績受到一些重組費用的影響，這些費用主要與我們的生產策略以及Kite公司的業務活動有關。正如我們在2023年下半年所討論的那樣，我們一直在採取措施改進業務模式和費用結構，為2024年的強勁成長做好準備。因此，我們的GAAP業績反映了2023年約5億美元的相關費用，即每股0.40美元，並導致全年GAAP每股收益為4.40美元（原文如此）[4.50美元]。

Moving to our fourth quarter results, starting on Slide 28. Total product sales, excluding Veklury, were $6.3 billion. Including Veklury, total product sales of $7.1 billion were down 4% from the same quarter in 2022. As expected, Veklury sales decreased year-over-year due to lower rates of COVID-19-related hospitalizations.

接下來是第四季業績，從第28頁開始。不包括Veklury在內，產品總銷售額為63億美元。包括Veklury在內，產品總銷售額為71億美元，較2022年同期下降4%。如預期，由於新冠肺炎相關住院率下降，Veklury的銷售額年減。

On Slide 29, you can see that on a non-GAAP basis, product gross margin was 86%, down 66 basis points from the prior year. R&D expenses were $1.5 billion, down 6% year-over-year. Acquired IPR&D was $347 million, reflecting payments related to our collaborations with Arcellx, Assembly Biosciences and Compugen and our XinThera acquisition.

如第29頁投影片所示，以非GAAP準則計算，產品毛利率為86%，較前一年下降66個基點。研發費用為15億美元，較去年同期下降6%。收購智慧財產權及研發費用為3.47億美元，其中包括與我們和Arcellx、Assembly Biosciences和Compugen的合作以及對XinThera的收購相關的付款。

SG&A was $1.6 billion, down 21% year-over-year, primarily related to the 2022 charge for the termination of the Everest collaboration that did not repeat in 2023. Excluding this 2022 charge, non-GAAP SG&A was down 1%. Operating margin was 39%, up from 37% in the fourth quarter of 2022, and effective tax rate in the fourth quarter was 17%, flat compared to the prior year.

銷售、管理及行政費用為16億美元，年減21%，主要原因是2022年因終止珠穆朗瑪峰合作計畫而產生的費用，該費用在2023年並未再次發生。剔除2022年的這筆費用後，非GAAP下的銷售、管理及行政費用下降1%。營業利益率為39%，高於2022年第四季的37%，第四季的實際稅率為17%，與去年同期持平。

Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1.67 in the fourth quarter of 2022.

整體而言，我們第四季的非GAAP稀釋後每股收益為1.72美元，而2022年第四季為1.67美元。

I'll move now to Slide 30 and our guidance, which assumes a generally stable macro environment, including FX at current rates.

現在我將轉到第 30 張投影片以及我們的指導意見，該指導意見假設宏觀環境總體穩定，包括當前匯率的外匯市場。

For the full year 2024, we expect total product sales in the range of $27.1 billion to $27.5 billion. We expect total product sales, excluding Veklury, in the range of $25.8 billion to $26.2 billion, representing growth of 4% to 6% for our base business year-over-year.

我們預計2024年全年產品總銷售額將介於271億美元至275億美元之間。若不計入Veklury，我們預期產品總銷售額將在258億美元至262億美元之間，這意味著我們基礎業務的年增長率將達到4%至6%。

Within total product sales, and as Johanna discussed, we expect HIV revenue to grow approximately 4%, and we expect Veklury sales of approximately $1.3 billion, although, as always, we caution you that Veklury sales remain highly variable depending on hospitalization rates. We do not expect to update our Veklury guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infections.

正如Johanna所討論的，我們預計HIV產品總銷售額將成長約4%，Veklury的銷售額預計約為13億美元。不過，我們一如既往地提醒各位，Veklury的銷售額仍會因住院率而出現較大波動。除非新冠肺炎感染情況出現非常明確的趨勢，否則我們預計在第三季財報電話會議上才會更新Veklury的業績預期。

Moving to the rest of the P&L and on a non-GAAP basis, we expect product gross margin to range between 85% and 86%, modestly lower than the 86.1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid-single-digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active Phase III programs.

從損益表其他部分以及非GAAP準則來看，我們預期產品毛利率將在85%至86%之間，略低於2023年報告的86.1%，這主要是由於腫瘤產品組合的貢獻不斷增長。我們預期研發支出將比2023年成長低至中等個位數百分比，這凸顯了隨著我們活躍的III期臨床試驗項目逐漸趨於穩定，支出成長已大幅放緩。

We expect acquired IPR&D to be approximately $350 million. Consistent with our approach in 2023, we will highlight incremental acquired IPR&D expenses as we announce new transactions and update our guidance each quarter. And we expect SG&A to decline by a mid-single-digit percentage compared to 2023. Excluding the $525 million legal settlement in 2023, we expect SG&A to grow in the low to mid-single-digit percentage range compared to SG&A of $5.5 billion in 2023, excluding this settlement.

我們預計收購的智慧財產權及研發費用約為3.5億美元。與2023年的做法一致，我們將在宣布新交易並每季更新業績指引時，重點在於新增的收購智慧財產權及研發費用。我們預計銷售、管理及行政費用（SG&A）將較2023年下降個位數百分比。若不計入2023年5.25億美元的法律和解費用，我們預期SG&A將較2023年55億美元的SG&A成長個位數百分比（低至中等）。

As a result, we expect our operating income for 2024 to be between $11.2 billion and $11.7 billion. We expect our effective tax rate to be approximately 19%. And finally, we expect our non-GAAP non-diluted (sic) [diluted] EPS to be between $6.85 and $7.25 per share for the full year, and GAAP diluted EPS to be between $5.15 and $5.55.

因此，我們預計2024年的營業收入將在112億美元至117億美元之間。我們預計實際稅率約為19%。最後，我們預計全年非GAAP未稀釋每股盈餘將在6.85美元至7.25美元之間，GAAP稀釋每股盈餘將在5.15美元至5.55美元之間。

As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023, similar to what we saw in the first quarter of 2023, and cell therapy to be flat to slightly up from Q4 of 2023.

提醒一下，我們預計 2024 年第一季 HIV 感染率將比 2023 年第四季下降 10% 至 12%，與 2023 年第一季的情況類似；細胞療法感染率將與 2023 年第四季持平或略有上升。

Moving to capital allocation on Slide 31, our priorities have not changed. In 2023, we returned $4.8 billion to our shareholders. This included $3.8 billion in dividend payments and $1 billion in share repurchases. Fourth quarter share repurchases were $150 million.

在第31頁關於資本配置的討論中，我們的優先事項並沒有改變。 2023年，我們向股東返還了48億美元，其中包括38億美元的股利支付和10億美元的股票回購。第四季股票回購額為1.5億美元。

For 2024, we announced today a 2.7% increase in our quarterly cash dividend to $0.77 per share, and we remain committed to growing our dividend over time, in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally, through select partnerships and business development transactions.

今天，我們宣布2024年季度現金股利將提高2.7%，至每股0.77美元。我們將繼續致力於隨著獲利成長而逐步提高股利。同時，我們將繼續透過特定的合作關係和業務拓展交易，在內部和外部加大對業務的投資。

Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis.

最後，我們將繼續利用股票回購來抵銷股權稀釋，並根據機會進行額外的回購。

With that, I'll invite the operator to begin the Q&A.

接下來，我將邀請接線生開始問答環節。

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

（操作說明）我們的第一個問題來自 TD Cowen 的 Tyler Van Buren。

Regarding the 2024 product sales guidance, I understand you guys are guiding to a near $900 million sales drop-off year-over-year for Veklury, but the guidance ex-Veklury looks to be a 5% year-over-year growth at the midpoint versus 7% for this year. So what do you view as some of the levers to ex-Veklury product sales guidance in '24, where we could see upside?

關於2024年的產品銷售預期，我了解到你們預期Veklury的銷售額將年減近9億美元，但剔除Veklury後，預期銷售額年增5%（取中間值），而今年的預期為7%。那麼，您認為2024年剔除Veklury後的產品銷售有哪些成長空間？

Thanks, Tyler. Let's have Andy start, please.

謝謝，泰勒。請安迪先開始。

Tyler, it's Andy. Thanks for the question. You're absolutely right. Our product sales guidance for products, excluding Veklury, implies 4% to 6% growth year-over-year, again, continuing the trend of strong growth that you've seen over the last 2 years. I'd also highlight that it implies a substantial moderation of our operating expense growth, which is an important piece of the puzzle that we spent a lot of time talking about.

泰勒，我是安迪。謝謝你的提問。你說得完全正確。我們除Veklury以外的產品銷售預期為年增4%至6%，延續了過去兩年強勁的成長動能。我還想強調的是，這意味著我們的營運費用成長將大幅放緩，而這正是我們之前多次討論的重要因素。

To your question specifically on product growth, the growth drivers for 2024 are the same as the growth drivers last year. You continue to see strong growth in our HIV business. As you see in the quarter, you really need to focus on the full year for the HIV to see the growth trend. And we saw another year of very strong growth across our HIV business for the full year in '23, we expect the same thing in '24, and you heard on the call that we're expecting at least 4% growth for the HIV business next year.

關於您提出的產品成長問題，2024年的成長驅動因素與去年相同。我們的HIV業務持續保持強勁成長。如您在本季所見，要了解HIV業務的全年成長趨勢，確實需要專注於全年數據。 2023年全年，我們的HIV業務再次實現了強勁成長，我們預計2024年也將如此。您在電話會議上也聽到，我們預計明年HIV業務的成長率至少為4%。

And then, of course, the cell therapy business and Trodelvy are expected to continue to grow as well. So those are the key growth drivers. We look forward to updating you throughout the year, but we're excited about the setup as we move into 2024.

當然，細胞療法業務和Trodelvy預計也將持續成長。這些是關鍵的成長驅動因素。我們期待在今年持續更新相關訊息，但我們對邁入2024年的發展前景充滿信心。

Our next question comes from the line of Salveen Richter with Goldman Sachs.

我們的下一個問題來自高盛的薩爾文·里希特。

On business development, you have noted the potential for a $5 billion to $6 billion deal in oncology or I&I. Where are you seeing the greatest opportunity to leverage your current clinical and commercial infrastructure?

在業務拓展方面，您提到腫瘤學或感染性疾病領域存在50億至60億美元的交易潛力。您認為在哪些方面最能充分利用您現有的臨床和商業基礎設施？

Great. Thanks, Salveen. This is Dan. Maybe I'll start and then ask others to add, but appreciate the question. I think just to reinforce our M&A strategy, I mean, nothing has changed from a business development perspective. And particularly, that's against the context of the background of nearly doubling our clinical trials underway over the past 4 years, multiple late-stage results. As you know, we're expecting more than 20 results still this year, and against the backdrop of no significant patent expirations in our business until early parts of the next decade.

太好了，謝謝Salveen。我是Dan。也許我會先說幾句，然後再請其他人補充，但我非常感謝你的提問。我想強調的是，從業務發展的角度來看，我們的併購策略並沒有改變。尤其是在過去四年裡，我們進行的臨床試驗數量幾乎翻了一番，並且已經取得了許多後期試驗結果。如你所知，我們預計今年還會有超過20項試驗結果公佈，而且在我們業務領域，直到下一個十年初期，都不會有重大專利到期。

So I think we'll continue to be opportunistic about pursuing business development in the 3 areas that we are focused on, which is obviously virology, oncology and inflammation, will be driven by the science. We continue to articulate that building our late research early development pipeline is probably one of our biggest focuses. And we'll continue to look at later-stage deals as they fit into our portfolio and our range.

因此，我認為我們將繼續積極把握機會，在我們重點關注的三個領域——病毒學、腫瘤學和發炎——開展業務拓展，而這一切都將以科學為驅動力。我們始終強調，建立後期研究和早期開發管線是我們最重要的工作之一。同時，我們也會持續關注符合我們產品組合和發展方向的後期專案。

It might also be important to note that we are back to pre-Immunomedics levels now relative to our leverage ratios. And so we're comfortable with our ability to put capital to work. But nothing has changed, and we feel we have everything within Gilead right now to achieve our ambitions over the second half of this decade.

值得注意的是，就槓桿率而言，我們目前的水準已恢復到收購Immunomedics之前的水準。因此，我們對自身的資本運用能力感到滿意。但一切並未改變，我們相信吉利德現在擁有實現未來五年目標所需的一切資源。

The next question comes from the line of Carter Gould with Barclays.

下一個問題來自卡特·古爾德在巴克萊銀行的職位。

This is Leon Wang on for Carter. So at this point, what conviction do you have anito-cel will differentiate on neurotox or Parkinsonism versus your competitors? And if the lack of neurotox data recapitulate later this year, would that be derisking in your view? And how important would that be in the market?

這裡是Leon Wang，代表Carter。那麼，目前您對Anito-Cel在神經毒性或帕金森氏症治療方面與競爭對手相比的優勢有多大信心？如果今年稍後神經毒性數據仍然匱乏，您認為這會降低風險嗎？這對市場來說有多重要？

Thank you, Leon. So we've got Cindy Perettie here to handle that.

謝謝你，萊昂。我們請辛蒂·佩雷蒂來處理這件事。

Thank you for the question. I think with the anito-cel data, we expect to complete the enrollment of our iMMagine-1 study this year, where we would have then 100 patients worth of data. And obviously, we're going to continue to look for safety signals, neurotox as you suggested. But to date, we have not observed any.

感謝您的提問。我認為，憑藉anito-cel的數據，我們預計今年就能完成iMMagine-1研究的入組，屆時我們將獲得100名患者的數據。當然，我們也會繼續關注安全性訊號，例如您提到的神經毒性。但到目前為止，我們尚未觀察到任何不良反應。

Your second part of that question was do we see that as a differentiator, and I would definitely see that as a differentiator in the marketplace if we were to come forward with a differentiated safety profile. I think the other component to remind you of is we also believe it's possible to have a differentiated efficacy profile. And today, based on the D-Domain and our transduction efficiency, we're able to use half the dose that we're seeing with our competitors, and that could play both with safety and efficacy.

您問題的第二部分是，我們是否認為這算是差異化優勢？如果安全性有顯著差異，我肯定會認為這是市場上的差異化優勢。我想提醒您的是，我們也相信可以擁有差異化的療效。目前，基於D結構域和我們的轉導效率，我們能夠使用競爭對手一半的劑量，這在安全性和療效方面都可能產生正面影響。

Our next question comes from the line of Terence Flynn with Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Terence Flynn。

I was just wondering if you could speak to your confidence level in Trodelvy in the frontline non-small cell lung trial setting here given the EVOKE-01 data, and if you're considering any potential changes to that frontline trial as a result?

我想問的是，鑑於 EVOKE-01 數據，您對 Trodelvy 在一線非小細胞肺癌試驗中的應用信心如何？您是否正在考慮因此對該第一線試驗進行任何潛在的調整？

Terence, it's Merdad. I think when we have looked at the data so far, and we're looking forward to sharing it with everyone as quickly as we can, probably one of the most important things in that data set that confirms where we were before is that we have not seen a difference in response rates between squamous cell carcinoma and non-squamous cell carcinoma. I think that was a bit of an overhang in the fall. And as we had mentioned earlier, we have not seen that to date, and that has been bolstered by the results of EVOKE-01.

特倫斯，我是梅爾達德。我認為，就我們目前所掌握的數據而言（我們期待盡快與大家分享），其中最重要的一點，也是證實我們先前結論的關鍵，就是我們沒有發現鱗狀細胞癌和非鱗狀細胞癌的治療反應率存在差異。我認為秋季時，這方面存在一些隱憂。正如我們之前提到的，到目前為止，我們還沒有發現這種差異，EVOKE-01 研究的結果也進一步證實了這一點。

So we do think that, increases our confidence that we don't need to think about, we'll look at that. Now there are other analyses we need to do to make sure that there are other predictors of response or not, and we'll be doing that, and we'll be sharing that over time. But right now, our overall confidence in Trodelvy, broadly speaking, remains very high. We have 3 approvals, and we have a broad development program against which we are executing really well.

所以我們認為，這增強了我們的信心，無需再為此擔憂。我們會繼續研究這個問題。當然，我們還需要進行其他分析，以確保有其他預測療效的指標，我們會進行這些分析，並會不時分享結果。但就目前而言，我們對Trodelvy的整體信心依然非常高。我們已獲得3項批准，並且擁有廣泛的研發項目，目前進展順利。

We continue to have additional trials that will read out this year in Phase III, specifically the TROPiCS-04 study that will be looking at the bladder cancer confirmation study with, hopefully, an OS signal, that study could actually give us beyond confirmatory trial in the U.S., it allows us to open conversations with regulators outside the U.S. And then we have promised an update on ASCENT03 in breast cancer, which we also think will broaden that. And then we now have a number of trials going on in a variety of indications, including ones we've mentioned in, for example, endometrial cancer.

今年我們還有一些三期臨床試驗的結果將會公佈，特別是TROPiCS-04研究，該研究旨在驗證膀胱癌的療效，並有望獲得總存活期（OS）訊號。這項研究不僅能為我們提供美國驗證性試驗以外的信息，還能讓我們與美國以外的監管機構展開對話。此外，我們承諾會更新ASCENT03乳癌試驗的最新進展，我們認為該試驗也將拓展我們的研究範圍。目前，我們正在進行多項針對不同適應症的試驗，包括我們先前提到的子宮內膜癌試驗。

So overall, what we've seen, EVOKE-01, and we're looking forward to sharing with you really maintains our level of enthusiasm about Trodelvy's long-term potential from an efficacy and safety standpoint across the board, and we have no plans to change EVOKE-03 at this time.

總的來說，我們所看到的 EVOKE-01，以及我們期待與您分享的內容，確實保持了我們對 Trodelvy 在各個方面（包括功效和安全性）長期潛力的熱情，我們目前沒有改變 EVOKE-03 的計劃。

Our next question comes from the line of Umer Raffat with Evercore.

我們的下一個問題來自 Umer Raffat 與 Evercore 的對話。

Look, it's very well understood for folks in biopharma community that no one can truly understand the full safety profile of any new drug based on Phase I data. And -- but this point has a lot of implications for your TAF litigation, obviously. So my question is, in a scenario where the Supreme Court takes up your petition, would that potentially be a venue where you could prove the level of evidence that's actually needed to make a decision on exception to duty and the type of decisions to make?

你看，生物製藥界人士都很清楚，僅憑一期臨床試驗數據，根本無法全面了解任何新藥的安全性。這一點顯然對你的TAF訴訟影響很大。所以我的問題是，如果最高法院接受你的申請，你是否有可能在那裡證明做出豁免義務決定所需的證據水平，以及應該做出何種決定？

I think Andy is going to take this one.

我覺得安迪會贏。

Umer, yes, thanks for the question. Yes, of course, I mean in front of the Supreme Court just like the appellate court, we'll be able to present the facts in our arguments as you'd expect.

烏默，是的，謝謝你的提問。當然，我的意思是，在最高法院，就像在上訴法院一樣，我們能夠按照你所預期的那樣，在辯論中陳述事實。

If you look at some of the briefing documents in the appellate court, I think they spell that out very clearly in terms of what happens over time with the development of TAF and what we knew at different points in time, and that would be available, as you'd expect, not only to the appellate court, but to the Supreme Court. And of course, those same facts would be presented at any trial if we ever get to that point.

如果你查閱上訴法院的一些案情摘要文件，你會發現它們非常清楚地闡述了TAF的研發歷程以及我們在不同時間點掌握的資訊。正如你所預料的，這些文件不僅會提交給上訴法院，也會提交給最高法院。當然，如果案件最終進入審判階段，這些事實也會在審判中被提出。

One other update on the TAF litigation. Again, Umer, nothing has changed from our perspective. We continue to have a lot of confidence. The one update I can provide is that the -- one of the very first trial in the federal court has been dismissed as of yesterday, I believe.

關於TAF訴訟案還有一點最新進展。烏默，從我們的角度來看，一切照舊。我們依然信心十足。我能提供的唯一最新消息是，聯邦法院最早的幾起審判之一，據我所知，已經在昨天被駁回了。

So it now looks like -- and again, this is consistent, as you know, with the thousands of other cases. I think it's now over 5,300 cases that have been dismissed by the courts, over 4,300 in the California state courts and over 1,000 in the federal court before they get to trial.

所以現在看來——而且正如你所知，這與其他數千起案件的情況一致。我認為目前已有超過5300起案件被法院駁回，其中超過4300起在加州州法院，超過1000起在聯邦法院，這些案件在開庭審理前就被駁回了。

So the first bellwether trial in the federal court, Umer, would now be in November instead of April. So we'll keep you up to date, and thanks for your question.

因此，聯邦法院的首例標竿性審判——烏默案——現在將推遲到11月，而不是原定的4月。我們會持續關注並向您報告最新進展，感謝您的提問。

Our next question comes from the line of Olivia Brayer with Cantor Fitzgerald.

我們的下一個問題來自奧利維亞·布雷耶和坎托·菲茨杰拉德的對話。

What were some of the dynamics that happened with Yescarta this quarter? And how should we be thinking about growth for 2024 from your cell therapy franchise just in light of a sequentially down quarter in 4Q?

Yescarta本季有哪些動態變化？鑑於第四季環比下滑，我們該如何看待貴公司細胞療法業務在2024年的成長前景？

Thanks a lot, Olivia, for the question. This is Cindy. We continue to be the leaders in cell therapy. And I think the piece that Johanna mentioned is that we are looking at how do we expand beyondthe existing ATCs. So the dynamics that we observed this quarter were capacity constraints within the existing ATCs that we have. We saw a little bit of in class and out-of-class competition.

非常感謝Olivia的提問。我是Cindy。我們始終是細胞療法領域的領導者。 Johanna提到的一點是，我們正在研究如何拓展現有ATC之外的業務。本季我們觀察到的動態是現有ATC的產能限制。我們也看到了一些同類產品和同類產品之間的競爭。

And in parallel, we have been continuing to work on expanding our ATCs. So today, we have over 400 ATCs globally. We are moving out of urban centers and those academic centers into the community to meet patients where they are.

同時，我們也在持續拓展我們的抗愛滋病毒治療中心（ATC）。如今，我們在全球擁有超過400家ATC。我們正走出城市中心和學術中心，走進社區，以便在患者所在的地方為他們提供服務。

As Andy suggested, that -- bringing up those ATCs in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center up. So we expect to be flat to slightly up in quarter 1, and you'll start to see that return to growth in the second half of the year.

正如安迪所建議的，在社區內建立這些ATC（應用治療中心）將是我們未來策略的重要組成部分，但這確實比建立學術中心需要更長的時間。因此，我們預計第一季業績將持平或略有成長，您將在下半年開始看到成長動能。

Our next question comes from the line of Jeff Meacham with Bank of America.

我們的下一個問題來自美國銀行的傑夫·米查姆。

Great. Yes, I have another one on cell therapy, but more on the profitability. This is a franchise that's almost $2 billion in sales. You guys have improved the turnaround time. You've reached scale, you've treated a ton of patients. What can you tell us about the progress that you've made to making this a profitable franchise? I'm just thinking not for the current products, but also looking out 5 years plus?

太好了。是的，我還有一個關於細胞療法的問題，不過是關於獲利能力的。這是一個年銷售額接近20億美元的特許經營項目。你們已經縮短了周轉時間，達到了規模化，治療了大量患者。您能跟我們說說你們在使這個特許經營項目盈利方面取得了哪些進展嗎？我指的不僅是目前的產品，也包括未來五年甚至更長的發展前景。

Jeff, it's Andy. Thanks for the question. It's a great question. You're absolutely right. The cell therapy business has made tremendous progress over the last 5 or 6 years and evidenced most recently by the faster turnaround time in manufacturing that we talked about on our prepared remarks, going from 16 days to 14 days. And again, it's just the beginning from our perspective of what we can continue to do with this business.

傑夫，我是安迪。謝謝你的提問。這是一個很好的問題。你說得完全正確。細胞療法產業在過去五、六年取得了巨大的進步，最近的例子就是我們先前在準備的發言稿中提到的生產週期縮短，從16天縮短到了14天。而且，在我們看來，這只是個開始，我們在這個行業還有很大的發展空間。

So while we don't provide specific guidance, we have said when we announced the Kite transaction that we expected to be profitable, breakeven or profitable and accretive by the end of year 4. We got there shortly after that. All of the metrics that we look at on the business have improved over time.

因此，雖然我們不提供具體指引，但我們在宣布Kite交易時曾表示，預計到第四年末將實現盈利、盈虧平衡或盈利並增加收益。此後不久，我們就實現了這些目標。我們關注的所有業務指標都隨著時間的推移而改善。

We've continued to make significant progress on our manufacturing efficiency, manufacturing costs despite the fact that we've opened 3 global manufacturing centers. And each time you do that, when you move the commercial manufacturing, it impacts your gross margin. So I'm really proud of what the team has done.

儘管我們開設了三個全球製造中心，但我們在生產效率和製造成本方面仍然取得了顯著進展。每次開設新的製造中心，轉移商業生產環節，都會對毛利率產生影響。所以我為團隊的成就感到非常自豪。

And same thing on the operating costs. You see in the fourth quarter, we announced some restructuring charges, Jeff, that hit our GAAP results. Part of that was a restructuring at Kite, and Cindy and her team looked at the structure and made changes to the structure that we think will continue to drive growth and efficiency in the business over the long run.

營運成本方面也是如此。傑夫，你看，我們在第四季度宣布了一些重組費用，這影響了我們的GAAP表現。其中一部分是Kite公司的重組，辛蒂和她的團隊審查了公司結構，並做出了一些我們認為能夠長期推動業務成長和提高效率的調整。

So maybe the last thing I'd say is that when we look at the business, this is a business that we have line of sight to biologics margins and profitability. We're really growing the business, Jeff, as you know, for long-term sustainability and growth and less near-term profitability, but it's certainly exciting that the business is doing as well as it is.

最後我想說的是，當我們審視這項業務時，我們會發現生物製劑的利潤率和獲利能力是可以預見的。傑夫，正如你所知，我們真正致力於發展這項業務是為了實現長期的可持續發展和增長，而不是短期盈利，但業務目前取得的良好發展確實令人振奮。

I think the only thing I would add to Andy's comment is beyond the 3 manufacturing facilities, we also have our own viral vector facility. So given the fact that viral vector has had some supply challenges, that's something that we are not suffering from. So we own the sort of end-to-end cost of goods for our products.

我唯一想補充的是，除了三個生產基地之外，我們還有自己的病毒載體生產基地。因此，儘管病毒載體供應方面存在一些挑戰，但我們並沒有受到影響。所以，我們能夠掌控產品從生產到銷售的整個成本流程。

Our next question comes from the line of Michael Yee with Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

We had an HIV question. There were some comments around the dynamics of the channel mix as it relates to HIV pricing. And I was wondering if you could just remind us about what the driver of the benefit was in '22 and '23 and how that changed as we go into '24 and why that's difficult comps? Is that a change in mix between commercial and Medicaid swapping? Or maybe just explain that, that would help us understand what's going on there for '24.

我們收到了一個關於愛滋病毒相關問題。有人提到通路組合的動態變化與愛滋病毒定價之間的關係。我想請您簡單回顧一下2022年和2023年推動疫苗效益的主要因素是什麼，以及進入2024年後這些因素發生了哪些變化，為什麼難以進行比較？這是否與商業保險和醫療補助計劃之間的轉換有關？或者您能否解釋一下，這將有助於我們了解2024年的情況。

Sure, Michael. It's Johanna. Let me take that one. So what you're referring to is actually we saw some pricing favorability in Q4 of '22, nd the first half of 2023. That pricing favorability was mainly driven by actually just the inflation being so high, and therefore, some of our rebates are actually based on that inflation rate. And so therefore, there was actually upside during those quarters. We knew that, that was not going to repeat itself. So we had kind of shared with you, I think, from Q3 on, that this was going to normalize. And so that was kind of what happened in the first half of 2023.

當然，邁克爾。我是喬安娜。讓我來回答這個問題。您指的是我們在2022年第四季和2023年上半年確實看到了一些價格優惠。這種價格優惠主要是由於通貨膨脹率居高不下，因此，我們的一些返利實際上是根據通貨膨脹率來調整的。所以，在那幾季確實存在著價格上漲的情況。我們知道這種情況不會重演。因此，從第三季開始，我們就和您說過，這種情況將會恢復正常。而2023年上半年的情況也確實如此。

As we think about the second half of 2023 and mainly the fourth quarter, what we did see there is very strong demand and that continued throughout the whole year, but we had some fluctuations, some quarterly variabilities, mainly due to channel mix, and more government channels resulting in lower average realized price because of higher rebates.

當我們展望 2023 年下半年，尤其是第四季度時，我們看到需求非常強勁，並且這種強勁勢頭貫穿全年，但我們也看到了一些波動，一些季度性的變化，這主要是由於渠道組合的變化，以及政府渠道增多導致平均實際價格因回扣增加而降低。

And so you really have to look at it on a full year basis. And so that's why it's so important. You know that HIV performance will always have some quarterly variability and we always need to look at the full year to really get the full picture of what's going on.

所以，你必須從全年的角度來看待這個問題。這就是為什麼它如此重要。你知道，愛滋病毒感染總是會存在一些季度波動，我們需要查看全年數據才能真正了解事情的全貌。

HIV for the full year of 2023 grew 6%, with nearly $1 billion in revenue, growth driven by Biktarvy, obviously growing at 14% and at 48% share, with 3% share growth in that year, outpacing all competitors. And so we're really proud of the demand-driven results that we've seen in 2023.

2023年全年，HIV業務成長6%，營收近10億美元，主要得益於Biktarvy的強勁成長，其成長率高達14%，市佔率達48%，當年市佔率成長3%，遠超所有競爭對手。因此，我們對2023年所取得的由市場需求驅動的績效感到非常自豪。

And as we think about 2024 and our predictions for '24, we believe that our expectation is going to be in line with HIV treatment, which is still about 2 to 3 points. Layer on top of that, the demand growth from Biktarvy and Descovy for PrEP, and that's why we're expecting about a 4% growth in HIV.

展望2024年，我們對2024年的預測是，我們認為預期將與愛滋病治療的預期保持一致，即成長2%到3%。此外，Biktarvy和Descovy等PrEP藥物的需求成長也將推動愛滋病感染率上升，因此我們預期愛滋病感染率將成長約4%。

So that gives you the full picture of what's going on and what happened in the past. So we don't expect that on a yearly basis, but on a quarterly basis, we do expect that variability. And I would expect that, that will continue as we move forward.

這樣就能讓你全面了解當下的情況以及過去發生的事情。我們預計這種波動不會持續每年，但每季都會有波動。而且我預計，隨著時間的推移，這種波動還會持續下去。

Our next question comes from the line of Chris Schott with JPMorgan.

我們的下一個問題來自摩根大通的克里斯·肖特。

Can you just talk about the TIGIT program and what drove the decision to step up your investments here, and maybe as part of that, can you elaborate a little bit more on the decision to deemphasize the PD-L1 high population, I guess, in favor of the all-comer study? So any color there would be appreciated.

您能否談談TIGIT項目，以及促使您們加大投資的因素？另外，能否詳細解釋為什麼你們決定減少對PD-L1高表達人群的研究，而更傾向於納入所有受試者？任何相關資訊將不勝感激。

Chris, it's Andy. Maybe I'll start on the TIGIT program and the revised agreement with Arcus that we announced last week, and then Merdad can answer the second part of your question.

克里斯，我是安迪。或許我可以先談談TIGIT計畫以及我們上週宣布的與Arcus的修訂協議，然後梅爾達德可以回答你問題的第二部分。

Yes, it's relatively simple. If you step back, you've heard us say this before, but I'd reiterate that we value the partnership that we have with Arcus and the programs that their team has developed. And the recent updates to your question to the partnership really allow both companies to more efficiently deploy our teams and capital. We also focused on streamlining decision-making and the additional capital allows us to expand the overall clinical study footprint.

是的，這相對簡單。如果您仔細想想，我們之前也說過類似的話，但我還是要重申，我們非常重視與Arcus的合作關係，以及他們團隊開發的專案。最近關於合作關係的更新，確實讓兩家公司能夠更有效率地部署團隊和資金。我們也致力於簡化決策流程，而新增的資金則使我們能夠擴大整體臨床研究的規模。

So there are a number of things that both companies accomplished through the amendment. It does reinforce our support and belief in their programs broadly, not just TIGIT, but there's a lot to be excited about there that you'll see play out over the coming years.

因此，兩家公司透過這項修正案取得了多項成就。這不僅鞏固了我們對TIGIT專案的整體支持和信任，也進一步增強了我們對他們各項計畫的信心。未來幾年，我們將看到許多令人興奮的成果。

This is Merdad. I think you're referring to the ARC-10 study. And as you may recall, we started that study together with Arcus back in 2021 outside the U.S. with the chemo comparator arm. And at the time, there was really limited access to PD-1, PD-L1 inhibitors outside the U.S. And so we subsequently updated that study March of last year to include PD-L1 inhibitors as the standard of care was evolving.

我是Merdad。我想您指的是ARC-10研究。您可能還記得，我們​​和Arcus公司於2021年在美國以外地區啟動了這項研究，當時的研究對像是接受化療的患者。那時，美國以外地區獲得PD-1和PD-L1抑制劑的機會非常有限。因此，隨著PD-1和PD-L1抑制劑治療方案的不斷發展，我們在去年3月更新了這項研究，將PD-L1抑制劑納入其中。

It took us time to get this all going. And while that was happening, we had a number of competitors launch similar trials in the space with their TIGIT antibodies. So as a result of all that, the enrollment for the ARC-10 trial wasn't as robust as we had hoped for and as it had been.

我們花了不少時間才把這一切推進起來。同時，一些競爭對手也推出了類似的TIGIT抗體試驗。因此，ARC-10試驗的入組人數並沒有達到我們預期的程度。

And STAR-121, which is the all-comers study, was recruiting very well. And so we decided to really prioritize our efforts for that all-comers population where we think we could be first or second in class. And it was really a prioritization to ensure that we could stay ahead and keep moving the molecule forward as quickly as possible.

STAR-121（所有受試者的研究）的招募情況非常好。因此，我們決定將工作重點放在面向所有受試者的人群上，因為我們認為我們有可能在該領域取得領先或第二名。這樣做確實是為了確保我們能夠保持領先地位，並儘可能快速地推進分子研發。

Our next question comes from the line of Brian Abrahams with RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的布萊恩亞伯拉罕。

I realize this is pending KOL and regulatory discussions, but I was wondering if you could frame the potential next steps for the PD-L1 poor responders. Do you think this is a fileable population for Trodelvy in second line lung or might you also consider running another study in that population? And along those lines, I'm curious what you're expecting to see from the updated EVOKE-02 data this year and how that might shape your overall plans for Trodelvy in lung?

我知道這需要與關鍵意見領袖 (KOL) 和監管機構進行討論，但我很想知道您能否概述 PD-L1 低反應患者的下一步計劃。您認為這類患者是否適合將 Trodelvy 作為二線肺癌治療方案納入研究？或者您會考慮針對該族群進行另一項研究？此外，我還想了解您對今年更新的 EVOKE-02 數據有何預期，以及這些數據將如何影響您對 Trodelvy 在肺癌治療方面的整體計劃？

Sure. This is Merdad again, Brian. So maybe I'll take the second part first. On EVOKE-02, as you can imagine, we showed last year ORR data, and those data are going to continue to mature as time goes by. So we should start to see more PFS data this year, that will demonstrate, we hope, continued confidence in the frontline setting for Trodelvy based on that study that's running in parallel with EVOKE-03.

當然。我是 Merdad，Brian。那我就先回答第二部分吧。關於 EVOKE-02 研究，如你所想，我們去年公佈了客觀緩解率 (ORR) 數據，隨著時間的推移，這些數據還會不斷改進。因此，我們今年應該會看到更多無進展生存期 (PFS) 數據，我們希望這些數據能夠進一步證明，基於與 EVOKE-03 研究並行開展的這項研究，人們對 Trodelvy 一線治療的信心仍然存在。

So we've gotten a lot of confidence from EVOKE-02 to support 03. And so we are going to keep updating that to make sure we get that. And it does actually reflect back on one of the earlier questions around changes to EVOKE-03. And EVOKE-02 really keeps us in the right population, gathering data so that we can make sure there are no changes that are necessary.

因此，我們從 EV​​OKE-02 中獲得了足夠的信心來支持 EVOKE-03。我們會持續更新 EVOKE-02，以確保其能夠滿足需求。這其實也回應了先前關於 EVOKE-03 變更的問題。 EVOKE-02 確實能夠幫助我們找到合適的目標人群，收集數據，從而確保無需進行任何更改。

In terms of the PD-1 nonresponders in EVOKE-01, yes, we -- I think we need more time to study the data and we need to talk to the KOLs and the regulators to see there's -- I wouldn't rule out the possibility that we could discuss with regulators a possibility of using these data, and I want to be realistic and say that a second trial, another trial may be necessary and something that we would -- we are thinking about right now. And we'll let you know as we update our situation there. And of course, we'll share the data from EVOKE-01 so that we can talk about it in more detail over time.

關於EVOKE-01試驗中PD-1無應答者的情況，是的，我認為我們需要更多時間來研究數據，也需要與關鍵意見領袖（KOL）和監管機構溝通，看看是否有可能——我不會排除與監管機構討論使用這些數據的可能性。我想坦誠地說，可能需要進行第二項試驗，也就是另一項試驗，這也是我們目前正在考慮的問題。一旦有新的進展，我們會及時通知大家。當然，我們也會分享EVOKE-01試驗的數據，以便日後進行更詳細的討論。

Our final question comes from the line of Colin Bristow with UBS.

最後一個問題來自瑞銀集團的 Colin Bristow。

Can you hear me?

你聽得到我嗎？

Yes, we can hear you very well.

是的，我們聽得很清楚。

Maybe on the back to Brian's question with regards to the observation that the OS benefit was greatest in those nonresponsive to prior I/O in the EVOKE-01 study. This seems to align with a recent study, which showed that Trop-2 expression levels are associated with the primary resistance to checkpoint inhibition in non-small cell patients.

或許可以回到Brian提出的問題，EVOKE-01研究中，對先前免疫檢查點抑制劑無反應的患者獲得最大總存活期獲益此觀察結果。這似乎與一項近期研究相符，該研究表明，Trop-2表達水平與非小細胞肺癌患者對免疫檢查點抑制劑的原發性抗藥性有關。

And so -- and from that, it obviously raises the question on the potential synergy of Trop-2 and anti-PD-1s. I wondered if you had any thoughts on this. Or do you have any data which kind of gives you comfort?

因此，這顯然引出了一個問題，即Trop-2和抗PD-1藥物之間可能存在協同作用。我想知道您對此有何看法？或者您是否有任何數據可以佐證這一點？

We've spoken about this before. It's definitely something that we are cognizant of and following. One of the data readouts that we are continuing to collect right now from EVOKE-01 is Trop-2 expression, and I think that will help us as we look at those data and share them to formulate any hypotheses that may warrant changes. So Trop-2 expression is definitely something that we are focused on and we'll continue to follow and evaluate.

我們之前討論過這個問題。我們當然非常關注並且持續跟進。目前我們正在從EVOKE-01項目中收集的數據之一是Trop-2的表達水平，我認為這將有助於我們分析這些數據並進行共享，從而提出任何可能需要調整的假設。因此，Trop-2的表達水平是我們重點關注的方面，我們會繼續追蹤和評估。

I would now like to pass the conference back to Daniel for any closing remarks.

現在我謹將會議交還給丹尼爾，請他作總結發言。

Well, thanks, everyone, for joining. We very much appreciate it. Before we conclude the call, let me just wrap up with a couple of comments and summary from what the team has accomplished over the past year and are set up for '24. First, our full year performance reinforces the continued growth and strength of the business.

感謝各位的參與，我們非常感激。在結束本次電話會議之前，我想先就團隊過去一年的成就以及2024年的準備工作做幾點總結。首先，我們全年的業績進一步鞏固了公司業務的持續成長和強勁勢頭。

Gilead's HIV portfolio is unmatched, with the standard of care daily oral treatment and a rapidly advancing pipeline with potentially best-in-class long-acting regimens. And in oncology, we now have a business that is annualizing at over $3 billion with clear opportunity for future growth. So it's a base business last year, this year.

吉利德的HIV產品組合無可匹敵，擁有標準的每日口服治療方案，以及快速推進的研發管線，其中可能包含同類最佳的長效治療方案。在腫瘤領域，我們目前的業務年收入超過30億美元，未來成長潛力巨大。因此，無論是去年還是今年，這都是一項基礎業務。

And second, our strong business allows us to take bold bets in innovation, and you'll see multiple updates on how those are playing out in 2024 and beyond. We're pursuing science with a high potential impact for patients, and that comes with risk. But importantly, we've built a resilient business and a robust portfolio that allows for that. In 2024, we expect at least 20 key updates across our HIV and oncology portfolios.

其次，我們強大的業務實力使我們能夠在創新領域進行大膽投入，您將在2024年及以後看到這些投入的進展。我們正在追求對患者俱有巨大潛在影響的科學研究，其中蘊含著風險。但重要的是，我們已經建立了一個具有韌性的業務和強大的產品組合，從而能夠應對這些風險。 2024年，我們預計在愛滋病和腫瘤產品組合中至少推出20項關鍵更新。

And finally, I just want to thank the Gilead teams for all their hard work in delivering our strong full year performance and advancing our portfolio. We look forward to keeping all of you updated on our progress throughout 2024. Thanks again for joining today.

最後，我要感謝吉利德團隊的辛勤付出，正是他們的努力使我們全年業績強勁增長，並推動了我們產品組合的進步。我們期待在2024年繼續向大家報告我們的進展。再次感謝各位今天的參與。

That concludes today's call. Thank you for your participation, and enjoy the rest of the day.

今天的電話會議到此結束。感謝您的參與，祝您今天餘下的時間愉快。