吉利德科學 (GILD) 2024 Q1 法說會逐字稿

Good afternoon, everyone, and welcome to Gilead's First Quarter 2024 Earnings Conference Call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. (Operator Instructions) I'll now hand the call over to Jacquie Ross, VP, Investor Relations and Corporate Strategic Finance.

各位下午好，歡迎參加吉利德2024財年第一季財報電話會議。我是主持人麗貝卡。稍後我們將開始發言。 （操作說明）現在我將把電話交給投資者關係和企業策略財務副總裁杰奎·羅斯。

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the first quarter of 2024. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com.

謝謝麗貝卡。今天收盤後不久，我們發布了2024年第一季的獲利報告。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看。

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 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. Please refer to Slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially.

在正式開始之前，請允許我提醒各位，我們將做出一些前瞻性陳述。請參閱投影片2，以了解與前瞻性陳述相關的風險和不確定性，這些風險和不確定性可能導致實際結果與預期結果有重大差異。

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. I want to start by thanking the Gilead teams for delivering a strong first quarter, which you see in our commercial performance and our clinical execution. Total product sales, excluding Veklury, grew 6% year-over-year to $6.1 billion, driven by higher demand across HIV, oncology and liver disease. Veklury sales continue to track with the rates of hospitalization for COVID-19 and reached a total of $555 million.

謝謝Jacquie，大家下午好。首先，我要感謝吉利德團隊，他們出色地完成了第一季的工作，這體現在我們的商業業績和臨床執行上。不包括Veklury在內，產品總銷售額年增6%，達到61億美元，主要得益於HIV、腫瘤和肝病領域需求的成長。 Veklury的銷售額持續與COVID-19住院率保持同步成長，總額達5.55億美元。

Once again, sales growth for the quarter reflected the diversity of our portfolio. HIV product sales grew 4% year-over-year. Oncology product sales were up 18%, driven by Trodelvy, which is well established as the #1 regimen for second-line metastatic triple-negative breast cancer and by our transformative cell therapies. As we outlined at the recent Kite analyst event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy, such as expand into community networks in the U.S., more than double our manufacturing capacity, and move into new indications and disease areas with next-generation products.

本季銷售成長再次反映了我們產品組合的多樣性。 HIV產品銷售額較去年同期成長4%。腫瘤產品銷售額成長18%，主要得益於Trodelvy（一種已確立為二線轉移性三陰性乳癌首選治療方案的藥物）以及我們變革性的細胞療法。正如我們在近期於馬裡蘭州舉行的Kite分析師活動上所概述的，我們制定了令人振奮的計劃，以鞏固我們在細胞療法領域的市場領先地位，例如拓展美國社區醫療網絡、將產能提高一倍以上，以及利用下一代產品進軍新的適應症和疾病領域。

From an EPS perspective, first quarter results reflect the close of the CymaBay acquisition with an inquired IP R&D charge of $3.9 billion or an expense of $3.14 per share. Excluding this charge, non-GAAP diluted EPS would have been $1.82 for the first quarter, which is above expectations, driven by higher product sales. The CymaBay acquisition brings us an important registrational medicine, seladelpar, which has the potential to address significant unmet need in liver disease. We have filed for regulatory approval of seladelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August.

從每股盈餘（EPS）的角度來看，第一季業績反映了CymaBay收購的完成，以及39億美元的智慧財產權研發費用（相當於每股3.14美元）。若不計入此項費用，第一季非GAAP稀釋後每股收益將為1.82美元，高於預期，主要得益於產品銷售額的成長。 CymaBay的收購為我們帶來了重要的註冊藥物seladelpar，該藥物有望滿足肝病領域尚未得到充分滿足的醫療需求。我們已向FDA和EMA提交了seladelpar用於治療原發性膽汁性膽管炎（PBC）的上市申請，預計FDA將於8月做出審批決定。

If approved, we will leverage our industry-leading commercial infrastructure and long-standing expertise in liver disease to bring seladelpar a potentially transformative therapy to people with PBC who might benefit. Moving to clinical execution. We're very pleased with momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI. Based on the strength of the data, we've initiated Phase III trials for bictegravir and lenacapavir, our novel once-daily oral regimen, and plan to advance once weekly oral programs, including lenacapavir plus islatravir into Phase III.

如果獲得批准，我們將利用我們行業領先的商業基礎設施和在肝病領域長期積累的專業知識，為可能受益的原發性膽汁性膽管炎（PBC）患者帶來具有潛在變革意義的seladelpar療法。接下來將推動臨床實施。我們對HIV產品線的進展感到非常滿意，這體現在我們於CROI大會上發表的80篇資料摘要中。基於這些數據的優勢，我們已啟動了bictegravir和lenacapavir（一種新型每日一次口服方案）的III期臨床試驗，併計劃推進包括lenacapavir聯合islatravir在內的每週一次口服方案進入III期臨床試驗。

Later this year, we will host an HIV analyst event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long-acting therapies.

今年晚些時候，我們將舉辦一場愛滋病毒分析師活動，分享我們將如何透過創新的預防和治療方案（包括下一代長效療法）進一步塑造愛滋病毒格局的細節。

Before I pass it to Johanna, I will briefly recap our 2024 milestones on Slide 6. We have already achieved first patient in for the Phase III ARTISTRY-1 and ARTISTRY-2 trials, evaluating once-daily lenacapavir in combination with bictegravir as well as Phase II first patient in for SWIFT evaluating GS-1427, our oral alpha-4-beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from 3 Phase III clinical trials for Trodelvy and lenacapavir.

在將發言權交給 Johanna 之前，我將在第 6 張投影片上簡要回顧我們 2024 年的里程碑。我們已經完成了 III 期臨床試驗 ARTISTRY-1 和 ARTISTRY-2 的首例患者入組，這兩項試驗旨在評估每日一次的 lenacapavir 聯合 bictegravir 的療效；此外，我們還完成了 II 期臨床試驗 SWIFT 的首例患者入組，該試驗旨在評估我們的口服 α4β7 抑制劑。我們接下來的里程碑進展順利，包括 Trodelvy 和 lenacapavir 的三項 III 期臨床試驗的最新進展。

Looking ahead to the rest of 2024, this is a time of focused execution for Gilead. We will see disciplined and agile in our approach, and we will focus the organization on both near-term execution and longer-term plans. With 54 clinical programs in play, no major patent expiration for the decade and many opportunities for growth, we have a lot of potential and a lot to deliver.

展望2024年剩餘時間，吉利德將專注於執行。我們將採取嚴謹而靈活的方式，並集中精力兼顧近期目標和長期規劃。目前，吉利德擁有54個在研臨床項目，未來十年內沒有重大專利到期，且成長機會眾多，我們潛力巨大，也肩負著實現目標的重任。

My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Johanna.

再次感謝吉利德團隊本季的出色工作，以及我們多元化療法組合所取得的持續進展。接下來，我將把發言權交給喬安娜。

Thanks, Dan, and Good after noon, everyone. With the first quarter marking the ninth consecutive quarter of year-over-year growth for our base business, our teams delivered a strong start to 2024, notably navigating the seasonal first quarter dynamics and establishing a firm base on which we can continue to build this year.

謝謝丹，大家下午好。第一季是我們基礎業務連續第九個季度實現同比增長，我們的團隊為2024年開了個好頭，尤其值得一提的是，他們成功應對了第一季的季節性波動，並為我們今年的持續發展奠定了堅實的基礎。

Beginning on Slide 8, total product sales, excluding Veklury, were $6.1 billion for the first quarter, up 6% year-over year, reflecting solid growth of our HIV, oncology and liver disease businesses. Including Veklury, total product sales were $6.6 billion, up 5% year-over-year.

從第8張投影片開始，不包括Veklury在內，第一季產品總銷售額為61億美元，年成長6%，反映了我們HIV、腫瘤和肝病業務的穩健成長。包括Veklury在內，產品總銷售額為66億美元，較去年同期成長5%。

Moving to HIV on Slide 9. Sales were up 4% year-over-year to $4.3 billion, primarily driven by higher demand as well as favorable pricing dynamics in Europe that are not expected to repeat. Quarter-over-quarter sales were down 7%, driven by the typical seasonality we experienced in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is, in general, more variable and less indicative of overall trends than the full year. This is evident in the first quarter of every year where inventory drawdown typically occurs following a build that generally happens towards the end of the prior year and patient co-pays and deductibles reset at the start of every year, and together with shifts in channel mix lowers average realized price in the first quarter.

投影片9：愛滋病毒相關數據。銷售額年增4%，達到43億美元，主要得益於需求成長以及歐洲市場有利的定價策略，但預計這種策略不會重現。環比銷售額下降7%，主要受第一季常見的季節性因素影響，部分被需求成長所抵銷。需要注意的是，與全年數據相比，季度愛滋病毒成長通常波動更大，更難以反映整體趨勢。這一點在每年的第一季尤其明顯：庫存通常會在上一年年底累積後下降，患者的自付額和免賠額會在每年年初重置，再加上通路組合的變化，導致第一季的平均實際售價降低。

As always, we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year. We continue to expect approximately 4% HIV sales growth for 2024. Supporting that outlook, the treatment market grew in line with our expectations, as shown on Slide 10. Biktarvy remains the leading regimen for HIV treatment across major markets for new starts as well as for those switching regimens with sales up 10% year-over-year to $2.9 billion, reflecting strong demand.

與往年一樣，隨著時間的推移，這些季度定價和庫存動態通常會趨於正常化。我們仍預計2024年HIV藥物銷售額將成長約4%。如投影片10所示，治療市場成長符合我們的預期，也印證了這個預測。 Biktarvy仍然是主要市場中HIV治療的首選方案，無論是新患者還是轉換治療方案的患者，其銷售額同比增長10%至29億美元，反映出強勁的市場需求。

Quarter-over-quarter, sales were down 5% as the higher demand was offset by the typical seasonal factors discussed earlier. It's notable that 6 years after launch, Biktarvy continues to gain market share in the U.S. up 3 percentage points year-over-year to approximately 49% share and once again, outpacing all other branded regimens for HIV treatment. Moreover, we continue to see Biktarvy's benefit extend into broader populations of people with HIV. Most recently, Biktarvy was granted FDA approval for use in virologically suppressed individuals with known or suspected M184 resistance, a common form of treatment resistance.

環比來看，銷售額下降了5%，原因是前文所述的季節性因素抵銷了需求的成長。值得注意的是，在上市六年後，Biktarvy在美國的市佔率持續成長，年增3個百分點，達到約49%，再次超越了所有其他品牌的HIV治療方案。此外，我們持續看到Biktarvy的益處惠及更廣泛的HIV感染族群。最近，Biktarvy獲得了FDA的批准，可用於已知或疑似M184抗藥性（一種常見的治療抗藥性形式）的病毒學抑制患者。

Turning to prevention. Descovy sales were down 5% year-over-year to $426 million, driven by lower average realized price due to channel mix, partially offset by higher demand. Sequentially, sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand. While market volumes in February were temporarily disrupted by the cyberattack on Change Healthcare, volumes readily recovered in March. Overall, the PrEP market continued to demonstrate robust growth, up over 11% in the first quarter, with Descovy maintaining over 40% PrEP market share in the U.S. despite the availability of other regimens, including generics.

轉向預防方面。受通路組合變化導致平均實際售價下降的影響，Descovy 的銷售額年減 5% 至 4.26 億美元，但部分被需求成長所抵銷。環比來看，銷售額下降 16%，反映了前文所述的季節性因素，但部分也被需求成長所抵銷。儘管 2 月市場銷售因 Change Healthcare 遭受網路攻擊而暫時中斷，但 3 月銷售量迅速恢復。總體而言，PrEP 市場持續保持強勁成長，第一季成長超過 11%，儘管其他療法（包括仿製藥）已上市，Descovy 在美國 PrEP 市場的份額仍保持在 40% 以上。

This is a solid setup as we look to potentially launch lenacapavir as early as late next year as the first and only twice yearly subcutaneous prevention option. Given Gilead's strong commercial foundation across treatment and prevention, we are well positioned to maintain leadership in HIV as we look to the evolving marketplace of daily orals, long-acting orals and long-acting injectables.

我們目前的佈局非常穩固，預計最快在明年年底推出lenacapavir，作為第一個也是目前唯一一個每年兩次皮下注射的預防方案。鑑於吉利德在治療和預防領域強大的商業基礎，我們有信心在不斷變化的每日口服、長效口服和長效注射市場中保持HIV領域的領先地位。

Moving to liver disease on Slide 11. Sales for the first quarter were $737 million, up 9% year-over-year, primarily driven by favorable inventory dynamics and the timing of purchases by the Department of Corrections for our HCV products as well as higher demand across HCV, HBV and HDV. Sequentially, sales were up 7%, primarily reflecting the timing of HCV purchases.

第11頁幻燈片將介紹肝病。第一季銷售額為7.37億美元，年增9%，主要得益於有利的庫存動態、懲教部門採購我們丙型肝炎產品的時機以及丙型肝炎、乙型肝炎和丁型肝炎產品需求的增長。環比成長7%，主要反映了丙型肝炎產品採購的時機。

Despite fewer HCV starts globally year-over-year, our viral hepatitis portfolio overall has remained stable and continues to be a meaningful contributor to our commercial performance. This strength is underpinned by our extensive global footprint and expertise in the treatment of liver diseases. To that end, pending approval, Gilead is excited to bring seladelpar to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the U.S. and about 125,000 people in Europe. With the sales force that covers almost 80% of the U.S. prescriber base for PBC, we expect to readily make seladelpar available to patients upon approval in the second half of this year.

儘管全球丙型肝炎病毒感染病例同比有所減少，但我們的病毒性肝炎產品組合整體保持穩定，並繼續為我們的商業業績做出重要貢獻。這一優勢得益於我們廣泛的全球佈局和在肝病治療領域的專業知識。為此，在獲得批准後，吉利德很高興能將seladelpar帶給部分原發性膽汁性膽管炎（PBC）成人患者，預計將惠及美國約13萬名患者和歐洲約12.5萬名患者。憑藉覆蓋美國近80% PBC處方醫生的銷售團隊，我們預計seladelpar將在今年下半年獲得批准後立即投入使用。

Seladelpar has demonstrated the potential to be best-in-class with a differentiated clinical profile to existing and emerging therapies, particularly on a key symptom of the disease, pruritus. Following its launch in 2024, we expect seladelpar to contribute modestly to sales and more meaningfully in 2025 and beyond.

Seladelpar 已展現出成為同類最佳藥物的潛力，其臨床療效與現有及新興療法相比具有顯著差異，尤其是在緩解該疾病的關鍵症狀——瘙癢方面。我們預計，Seladelpar 將於 2024 年上市，初期銷售額貢獻適中，並在 2025 年及以後取得更顯著的業績成長。

Turning to Slide 12. Veklury continues to be the standard of care antiviral for hospitalized patients treated with COVID-19, with market share well over 60% in the United States. COVID-related hospitalizations were lower in the first quarter with the winter wave peaking earlier than expected in the U.S. and Europe as compared to other regions such as Japan. As a result, Veklury sales overall were down 3% year-over-year and down 23% sequentially to $555 million.

請看第12張投影片。 Veklury仍是新冠肺炎住院患者的標準抗病毒藥物，在美國的市佔率超過60%。與日本等其他地區相比，美國和歐洲的冬季疫情高峰出現得早於預期，導致第一季新冠肺炎相關住院人數下降。因此，Veklury的總銷售額年減3%，季減23%，至5.55億美元。

Shifting to oncology on Slide 13. Sales were up 18% year-over-year to $789 million and are now firmly above a $3 billion annual run rate. Having treated over 50,000 patients to date, we look forward to bringing our portfolio of medicines and future treatments across lines of therapies and tumor types to many more patients around the world.

第13頁幻燈片轉向腫瘤學領域。銷售額年增18%至7.89億美元，目前已穩居30億美元年化銷售額以上。迄今為止，我們已治療超過5萬名患者，並期待將我們涵蓋多種療法和腫瘤類型的藥物組合及未來治療方案帶給全球更多患者。

Moving to Slide 14. Trodelvy sales for the first quarter exceeded $300 million, up 39% year-over-year, reflecting continued demand. Sequentially, sales were up 3%, primarily driven by demand outside the U.S. as well as unfavorable fourth quarter pricing dynamics in Europe that did not repeat. This was partially offset by inventory dynamics in the U.S. where we saw a drawdown in the first quarter.

翻到第14張投影片。 Trodelvy第一季銷售額超過3億美元，較去年成長39%，反映市場需求持續強勁。環比來看，銷售額成長3%，主要得益於美國以外市場的需求成長，以及歐洲市場第四季不利的價格走勢並未重現。美國市場的庫存變化部分抵消了這一增長，我們在第一季看到庫存下降。

Overall, Trodelvy''s strong market share reflects its awareness amongst providers and patients. In second-line metastatic triple-negative breast cancer, Trodelvy remains the leading regimen with approximately 1/3 in the U.S. And in the pre-treated HR+/HER2- metastatic breast cancer setting, Trodelvy has demonstrated continued adoption, most notably in the IHC0 setting.

總體而言，Trodelvy 強大的市場份額反映了其在醫療服務提供者和患者中的知名度。在二線轉移性三陰性乳癌治療中，Trodelvy 仍然是領先的治療方案，在美國約佔三分之一的市場份額。在先前接受過治療的 HR+/HER2- 轉移性乳癌治療中，Trodelvy 也展現出持續的應用，尤其是在 IHC0 患者中。

We are confident Trodelvy continues to differentiate itself with its safety profile and clinically meaningful survival benefits, with over 30,000 patients across tumor types already treated to date. We look forward to potentially extending Trodelvy's reach to many more patients in the years ahead particularly in bladder cancer, earlier-line breast cancer settings, and lung cancer.

我們相信，Trodelvy憑藉其安全性以及具有臨床意義的生存獲益，將繼續保持其獨特優勢，迄今為止，已有超過3萬名不同腫瘤類型的患者接受了該藥物治療。我們期待在未來幾年內，Trodelvy能夠惠及更多患者，尤其是在膀胱癌、早期乳癌和肺癌領域。

Turning to Slide 15, and on behalf of Cindy and the Kite team, Cell Therapy sales were $480 million in the first quarter, up 7% year-over-year. Sequentially, sales were up 3%, in-line with our guidance of flat to slightly up. We''re pleased to see continued demand for Yescarta and Tecartus in both existing and new markets across Europe and other geographies, such as in Japan where we have seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date.

翻到第15頁投影片，我謹代表Cindy和Kite團隊報告，第一季細胞療法銷售額為4.8億美元，年增7%。環比成長3%，符合我們先前持平或略微增長的預期。我們很高興看到Yescarta和Tecartus在歐洲及其他地區（例如日本）的現有市場和新市場都保持著持續的需求。在日本，我們在提升品牌份額和擴大授權治療中心網絡方面取得了顯著進展，迄今為止，我們的授權治療中心網絡已超過20家。

In the U.S., and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting.

在美國，根據我們最近的更新，我們看到了透過擴大授權治療中心和附屬衛星機構的數量，以及推動社區轉診增加來實現成長的機會。

For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter. We''ve identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, and we will continue to refine this "blueprint" so that we become more efficient at onboarding new centers over time. We expect to start seeing the Impact from this initiative towards the end of 2024.

例如，我們很自豪地宣布，我們在第一季與田納西腫瘤中心建立了旗艦級的社區合作計畫。我們從中總結出許多關於如何與社區腫瘤診所有效合作開展細胞療法的關鍵經驗，並將繼續完善這一“藍圖”，以便隨著時間的推移，更有效率地接納新的合作中心。我們預計在2024年底開始看到這項措施的影響。

Wrapping up the first quarter, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year-over-year.

第一季結束，我們今年開局強勁，這主要得益於我們各個核心業務的同比需求成長。

We look forward to carrying this momentum through 2024 and as we bring seladelpar to market later this year following approval. I'd like to thank the commercial teams and cross-functional partners across Gilead and Kite for their strong execution as we diligently expand our therapies to new populations, positively impacting more people all around the world.

我們期待將這一勢頭延續到2024年，並在今年稍後獲得批准後將seladelpar推向市場。我要感謝吉利德和Kite的商業團隊和跨職能合作夥伴，感謝他們高效的執行，使我們能夠穩步拓展療法，惠及更多人群，從而造福全球更多患者。

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

好了，接下來我將把電話交給梅爾達德。

Thank you, Johanna. We have had a busy first quarter at Gilead, with a cadence of clinical readouts that will continue throughout the rest of the year. Importantly, we anticipate an FDA regulatory decision on seladelpar and 3 Phase III updates across HIV prevention, bladder cancer, and breast cancer.

謝謝喬安娜。吉利德第一季非常忙碌，我們將持續發布一系列臨床試驗結果，這一趨勢將貫穿全年。尤其值得一提的是，我們預計將獲得FDA對seladelpar的監管審批決定，並宣布三項針對HIV預防、膀胱癌和乳癌的III期臨床試驗的最新進展。

Starting on Slide 17, we continue to progress our industry-leading Virology pipeline, which is building momentum following a data-rich presence at CROI in March. This included robust virologic suppression data from our once-daily oral combination of bictegravir with Lenacapavir from the Phase II portion of the ARTISTRY-1 trial.

從第 17 張投影片開始，我們將繼續推進我們領先業界的病毒學產品線，該產品線在 3 月的 CROI 大會上發布了大量數據後，發展勢頭強勁。其中包括來自 ARTISTRY-1 試驗 II 期部分的每日一次口服比克替拉韋與萊那卡帕韋組合的強效病毒抑制數據。

This novel combination has the potential to benefit people with HIV on complex regimens. We have since started 2 Phase III trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in the first half of 2025.

這種新型聯合療法有望使接受複雜治療方案的愛滋病毒感染者獲益。我們已啟動兩項此聯合療法的III期臨床試驗，一項針對病毒學抑制的患者，另一項針對病毒學抑制且接受過治療的患者。我們預計於2025年上半年完成病患招募。

We also have 2 once-weekly oral programs: first, a combination of lenacapavir with Merck's NRTTI, islatravir, in virologically suppressed people with HIV, expected to advance into Phase III later this year. And second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a Phase II study. This second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTIs are the standard-of-care treatment for HIV, and an important treatment option for clinicians who continue to prefer INSTI-based regimens.

我們還有兩項每週一次的口服治療方案：第一項是將lenacapavir與默克公司的核苷類逆轉錄酶抑制劑（NRTTI）islatravir聯合用於病毒學抑制的HIV感染者，預計今年稍後進入III期臨床試驗。第二項是將衣殼抑制劑與我們新型口服整合酶抑制劑GS-1720合併使用。我們正努力推進此聯合療法進入II期臨床試驗。第二項方案可望成為首個含有整合酶抑制劑（INSTI）的每週口服治療方案。整合酶抑制劑是HIV治療的標準療法，也是那些仍然傾向於使用基於整合酶抑制劑方案的臨床醫生的重要治療選擇。

Finally, we presented Phase Ib data from our twice-yearly parenteral program of lenacapavir plus our 2 broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the Phase II study in the second half of this year.

最後，我們在 CROI 會議上展示了我們針對 HIV 感染者開展的每半年一次的注射用 lenacapavir 加 2 種廣譜中和抗體的 Ib 期研究數據，我們計劃在今年下半年分享 II 期研究的數據。

Moving to PrEP, we plan to share an update from our Phase III PURPOSE-1 trial in the second half of this year. Data from PURPOSE-01, together with data from PURPOSE-2, is expected to support the filing of Lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as the first twice-yearly subcutaneous regimen, but could also be transformative in terms of adherence to HIV prevention regimens.

關於暴露前預防（PrEP），我們計劃在今年下半年公佈 PURPOSE-1 III 期試驗的最新進展。 PURPOSE-1 的數據，連同 PURPOSE-2 的數據，預計將支持 Lenacapavir 用於 HIV 預防的上市申請。這種 PrEP 方案不僅提供便捷的給藥方案（首個每年兩次皮下注射方案），而且有望顯著提高 HIV 預防方案的依從性。

Turning to Slide 18. Our Trodelvy program continues to be evaluated across a range of solid tumors with 7 Phase 3 trials currently underway across breast, bladder, and metastatic non-small cell lung cancers with plans to start the Phase III trial in endometrial cancer later this year.

翻到第 18 張投影片。我們的 Trodelvy 計畫正在對一系列實體瘤進行評估，目前正在進行 7 項 3 期試驗，分別針對乳腺癌、膀胱癌和轉移性非小細胞肺癌，並計劃於今年稍後啟動子宮內膜癌的 III 期試驗。

Abstract titles were just released yesterday for the upcoming ASCO meeting, and we''re pleased to have over a dozen Oncology presentations this year. We will be presenting late-breaking Phase III data from our second-line plus metastatic non-small cell lung cancer trial, EVOKE-01. Updated data from first-line, PD-L1 high subjects in Cohort A of the Phase II EVOKE-02 trial will also be shared. We plan on providing updates from Cohorts C and D, evaluating Trodelvy plus pembro and chemotherapy in PD-L1 all-comers at a medical congress in the second half of this year. In addition, presentations for both the Phase II EDGE-Gastric trial and Phase II ARC-9 studies will be highlighted.

昨天剛公佈了即將召開的ASCO會議的摘要標題，我們很高興今年將有十幾場腫瘤學方面的報告。我們將公佈二線及以上轉移性非小細胞肺癌患者治療方案的III期臨床試驗EVOKE-01的最新數據。此外，我們也將分享II期臨床試驗EVOKE-02中A組一線PD-L1高表達患者的最新數據。我們計劃在今年下半年的醫學大會上公佈C組和D組的最新數據，這兩組分別評估了Trodelvy合併帕博利珠單抗和化療在PD-L1高表達患者中的療效。此外，我們也將重點介紹II期臨床試驗EDGE-Gastric和II期臨床試驗ARC-9的研究結果。

Depending on the timing of event accruals, we anticipate 2 more Phase III updates this year for Trodelvy. These include overall survival data from our confirmatory Phase 3 bladder cancer study, TROPiCS-04, that could support Trodelvy's submission for full regulatory approval in the U.S. and enable ex-U.S. filings.

根據事件累積的時間安排，我們預計今年將發布Trodelvy的兩個III期臨床試驗更新數據。其中包括我們確證性III期膀胱癌研究TROPiCS-04的總存活期數據，這些數據可能支持Trodelvy在美國申請全面監管批准，並使其能夠在美國以外地區提交申請。

In TNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the Phase III ASCENT-03 trial in first-line PD-L1 negative patients later this year.

在 TNBC 中，Trodelvy 是唯一在二線治療中顯示出總生存期統計學顯著改善的 ADC，我們預計將於今年稍後分享一線 PD-L1 陰性患者的 III 期 ASCENT-03 試驗的最新進展。

Moving on to Cell Therapy. I''m pleased to share Kite's approach to the development of novel cell therapies that Cindy and the team presented at last month''s investor event. As you can see on slide 19 Yescarta and Tecartus established Kite as the leader in Cell Therapy, and we plan to potentially extend this leadership into multiple myeloma, while also paving the way for innovative next-generation constructs.

接下來談談細胞療法。我很高興與大家分享Kite在新型細胞療法開發方面的策略，這是Cindy和她的團隊在上個月的投資者活動上介紹的。正如您在第19頁幻燈片中看到的，Yescarta和Tecartus的合作使Kite成為細胞療法領域的領導者，我們計劃將這一領先地位擴展到多發性骨髓瘤領域，同時為創新型下一代構建體的研發鋪平道路。

On anito-cel in later-line multiple myeloma, we expect to provide a Phase II iMMagine-1 trial update in the second half of this year. This update follows the highly encouraging Phase I data presented at ASH last year, where anito-cel demonstrated durable responses with median progression-free survival not yet met at 26.5 months median follow-up --and no cases of parkinsonian symptoms observed in the trial.

關於anito-cel在多發性骨髓瘤後期治療的應用，我們預計今年下半年發布II期iMMagine-1試驗的最新進展。此次更新是在去年ASH年會上公佈的令人鼓舞的I期試驗數據之後進行的。 I期試驗數據顯示，anito-cel展現出持久的療效，中位追蹤時間為26.5個月，尚未達到中位無惡化存活期，且試驗中未觀察到帕金森氏症候群病例。

For our next generation cell therapy assets, we have bicistronic and optimized manufacturing constructs in Phase I trials, which are aimed at overcoming resistance mechanisms, providing potentially deeper and more sustained responses, and improving product potency. Beyond that, we have early research in allogeneic and in vivo CAR, with plans to expand into a range of other disease areas --such as multiple myeloma with anito-cel, solid tumors, and autoimmune diseases.

對於我們的下一代細胞療法資產，我們擁有雙順反子和優化生產結構的I期臨床試驗，旨在克服抗藥性機制，提供更深層、更持久的療效，並提高產品效力。此外，我們也在同種異體和體內CAR進行早期研究，並計劃拓展到其他疾病領域，例如抗細胞療法治療多發性骨髓瘤、實體腫瘤和自體免疫疾病。

Moving to Inflammation on Slide 20. We recently completed our acquisition of CymaBay and added seladelpar, an investigational PPAR-delta agonist to our portfolio. In Phase III clinical trials, seladelpar demonstrated significant improvement in both pruritus and markers of cholestasis related to the risk of progression for PBC. As previously announced, FDA and EMA accepted our regulatory filings for seladelpar for the management of PBC in certain adult patients. We anticipate an FDA regulatory decision by August 14th and a decision from European regulators early next year. We continue to work with global regulatory authorities to expand the reach of seladelpar for PBC patients.

幻燈片20：發炎。我們近期完成了CymaBay的收購，並將在研PPAR-δ激動劑seladelpar納入產品組合。在III期臨床試驗中，seladelpar顯著改善了原發性膽汁性膽管炎（PBC）患者的搔癢症狀以及與疾病進展風險相關的膽汁淤積指標。如同先前所宣布的，FDA和EMA已受理我們提交的seladelpar用於治療部分成年PBC患者的監管申請。我們預計FDA將於8月14日前做出審核決定，歐洲監管機構將於明年初做出決定。我們將繼續與全球監管機構合作，擴大seladelpar在PBC患者中的應用範圍。

Further, as we look at the rest of our Inflammation pipeline, we have several early phase assets that have progressed into Phase II trials, including our potentially first-in-class oral TPL2 inhibitor, a potentially best-in-class oral alpha-4-beta-7 anti-integrin, and an oral IRAK4 inhibitor.

此外，當我們審視我們發炎治療產品線的其他部分時，我們發現有幾項早期階段的資產已經進入 II 期試驗，其中包括我們可能成為同類首創的口服 TPL2 抑制劑、可能成為同類最佳的口服 α-4-β-7 抗整合素以及口服 IRAK4 抑制劑。

Wrapping up on Slide 21. We continue to progress on our clinical milestones for the year, and we have had 2 First Patients in and 1 data readout completed in the first quarter and we remain on-track for our remaining milestones.

投影片 21 總結完畢。我們繼續朝著今年的臨床里程碑取得進展，第一季我們已完成 2 例首例患者入院和 1 例數據讀取，我們仍按計劃朝著剩餘的里程碑前進。

And now, I''ll hand the call over to Andy.

現在，我把電話交給安迪。

Thank you, Merdad, and good afternoon, everyone. Beginning on Slide 23. It was a strong start to the year with our base business up 6% year-over-year. The solid growth achieved across HIV, Oncology, and Liver Disease offset the decline in Veklury, with total product sales up 5% year-over-year to $6.6 billion. As expected, our base business was down quarter-over-quarter, primarily driven by seasonal inventory and pricing dynamics in HIV.

謝謝Merdad，大家午安。從第23張投影片開始。今年開局強勁，我們的基礎業務年增6%。 HIV、腫瘤和肝病業務的穩健成長抵消了Veklury的下滑，產品總銷售額年增5%，達到66億美元。如預期，我們的基礎業務較上季下降，主要原因是HIV業務的季節性庫存和價格波動。

Moving beyond our revenue results, 2 items significantly impacted our EPS performance in the first quarter, as shown on Slide 24. First, our GAAP and non-GAAP results included an acquired IPR&D charge of $3.9 billion or $3.14 per share, associated with the close of the CymaBay acquisition. As an asset acquisition, this transaction was fully expensed in the first quarter. This was a nondeductible expense item, and as a result, impacted our effective tax rate. Excluding this expense, our non-GAAP EPS would have been $1.82 for the first quarter, above expectations primarily driven by higher sales.

除了營收業績之外，如投影片24所示，有兩個因素對我們第一季的每股盈餘(EPS)表現產生了顯著影響。首先，我們的GAAP和非GAAP業績均包含一項收購知識產權及研發(IPR&D)費用，金額為39億美元，即每股3.14美元，該費用與CymaBay收購案的完成有關。作為一項資產收購，該交易已在第一季全額計入費用。這是一項不可抵扣的費用項目，因此影響了我們的實際稅率。若剔除該費用，我們第一季的非GAAP每股收益將達到1.82美元，高於預期，主要得益於銷售額的成長。

The second item shown on the right hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results. As a reminder, this relates to the carrying value of the IPR&D indefinite-lived intangible assets acquired from Immunomedics.

右側第二項為減損費用，此費用已計入我們的GAAP財務報表，但未計入我們的非GAAP財務報表。需要說明的是，該費用與從Immunomedics公司收購的無限期使用壽命的IPR&D無形資產的帳面價值有關。

At the end of 2023, the carrying value was $5.9 billion, all associated with non-small cell lung cancer. As a result of the EVOKE-01 readout in late January, we have re-assessed and reduced the remaining value to $3.5 billion. This primarily reflects the smaller addressable market that Trodelvy could serve among 2L+ metastatic non-small cell lung cancer patients, a delay in expected launch timing, and associated competitive activity.

截至2023年底，帳面價值為59億美元，全部與非小細胞肺癌有關。由於1月底公佈的EVOKE-01試驗結果，我們重新評估並將剩餘價值下調至35億美元。這主要反映了Trodelvy在二線及以上轉移性非小細胞肺癌患者中的潛在市場規模較小、預期上市時間延遲以及相關的競爭活動。

We remain confident that Trodelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots-on-goal in new indications as well as earlier-lines of therapy, including some opportunities not included in the initial deal model. In the meantime, you can see that the impairment impacted our first quarter GAAP EPS by $1.46 per share.

我們仍然相信，Trodelvy 未來將帶來可觀的回報。目前，其年銷售額已超過 10 億美元，擁有強大的智慧財產權組合，並且其研發項目涵蓋多個新適應症以及早期療法，其中一些機會並未包含在最初的交易模式中。同時，您可以看到，此次減損使我們第一季的 GAAP 每股收益減少了 1.46 美元。

Moving to the rest of our non-GAAP results on Slide 25. For the first quarter, product gross margin was down modestly to 85.4%, primarily due to product mix. R&D and SG&A were each down 2% year-over-year. This is the second consecutive quarter of operating expense declines on a year-over-year basis, reflecting our continued focus on disciplined expense management. Our effective tax rate in the first quarter was a negative 30%, reflecting the non-deductibility of the CymaBay acquired IPR&D charge.

接下來是幻燈片25中關於非GAAP財務表現的其餘部分。第一季度，產品毛利率小幅下降至85.4%，主要原因是產品組合的變化。研發費用及銷售、管理及行政費用均較去年同期下降2%。這是連續第二季營運費用年減，反映了我們對嚴格費用管理的持續重視。第一季實際稅率為-30%，原因是收購CymaBay的智慧財產權及研發費用不可抵扣。

Overall, our diluted earnings per share was a negative $1.32 compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the CymaBay acquisition.

總體而言，我們的稀釋後每股收益為負 1.32 美元，而去年同期為正 1.37 美元，這主要反映了與收購 CymaBay 相關的每股 3.14 美元支出。

Switching to full-year guidance on Slide 26. There is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 to $27.5 billion; and we continue to expect total product sales, excluding Veklury, in the range of $25.8 to $26.2 billion, representing growth of 4% to 6% for our base business year-over-year. Additionally, there is no change to our Veklury guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veklury guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infections.

請參閱第26頁投影片，以了解全年業績指引。目前，我們對2024年的收入預期保持不變。我們仍預期產品總銷售額將在271億美元至275億美元之間；我們仍然預計，不計入Veklury，產品總銷售額將在258億美元至262億美元之間，年增4%至6%。此外，我們對Veklury的全年業績指引也保持不變，約13億美元。如上季所述，除非新冠肺炎疫情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的業績指引。

Shifting to the other parts of the P&L for 2024 on a non-GAAP basis. There is no change to our gross margin guidance where we continue to expect product gross margin in the range of 85% to 86%. We now expect R&D to grow at the higher end of our previous low-to-mid single digit growth range, reflecting the incremental expenses associated with the CymaBay acquisition.

接下來，我們將以非GAAP準則分析2024年損益表中的其他部分。我們的毛利率預期保持不變，預計產品毛利率仍將維持在85%至86%之間。由於收購CymaBay帶來的額外支出，我們現在預期研發支出將達到先前預測的個位數低至中等成長區間的較高水準。

We continue to expect SG&A expenses to decline a mid-single digit percentage relative to 2023. On a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate CymaBay expenses. However, we can manage this within the window of the previously-issued operating expense guidance. Acquired IPR&D is now expected to be approximately $4.4B, due to the CymaBay transaction as well as milestones anticipated throughout the rest of the year.

我們仍預期銷售、管理及行政費用（SG&A）將比2023年下降個位數百分比。以美元計算，由於納入了CymaBay的支出，SG&A預計將略高於我們先前的預期。但是，我們可以在先前發布的營運費用指引範圍內控制這一成長。由於CymaBay交易以及預計在今年剩餘時間內實現的里程碑事件，收購的智慧財產權和研發支出（IPR&D）預計約為44億美元。

Operating income is now expected in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the CymaBay transaction. Given the non-deductible impact of the CymaBay acquisition, the effective tax rate for 2024 is expected to be approximately 30%. This includes a negative impact of approximately 11% from the one-time charge for the acquisition of CymaBay. We therefore now expect diluted EPS in the range of $3.45 to $3.85. As shown on Slide 27, this has only been updated to reflect the transactions that were closed in the first quarter of 2024. Excluding these charges, you can see that we are comfortably within the range of the EPS guidance we shared back in early February. On a GAAP basis, we expect full year 2024 diluted EPS to be in the range of $0.10 and $0.50.

目前預計營業收入在70億美元至75億美元之間，這反映了更新後的收購智慧財產權及研發（IPR&D）預期以及與CymaBay交易相關的營運費用小幅成長。鑑於CymaBay收購的影響不可抵扣，預計2024年的實際稅率約為30%。這其中包括收購CymaBay的一次性費用帶來的約11%的負面影響。因此，我們現在預計稀釋後每股盈餘（EPS）在3.45美元至3.85美元之間。如投影片27所示，此預測僅更新了2024年第一季完成的交易。剔除這些費用後，我們仍維持在2月初發布的每股盈餘預期範圍內。以美國通用會計準則（GAAP）計算，我們預計2024年全年稀釋後每股收益介於0.10美元至0.50美元之間。

Moving to Slide 28. Our capital allocation priorities remain unchanged with sufficient flexibility in our balance sheet. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase to our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired CymaBay for $4.3 billion, adding seladelpar to our portfolio. Overall, we''ll continue to be disciplined in our use of capital. And while we will continue to be flexible and opportunistic--, it is unlikely that Gilead will be engaging in any sizeable M&A transactions in the near-term.

翻到第28頁。我們的資本配置優先事項保持不變，資產負債表仍保持足夠的靈活性。具體而言，如第一季所示，我們宣布將季度股息提高2.7%，並向股東返還了約14億美元。此外，我們以43億美元收購了CymaBay，將seladelpar納入我們的產品組合。總體而言，我們將繼續謹慎使用資本。雖然我們將繼續保持靈活和把握機遇，但吉利德近期不太可能進行任何大規模的併購交易。

Before I wrap it up, on Slide 29, a quick note on our expectations now that the CymaBay transaction has closed. Pending regulatory approval, we expect to launch seladelpar in the U.S. before the end of 2024, as Johanna highlighted earlier, with a modest revenue contribution expected this year.

在結束之前，我在第29頁幻燈片中簡要說明我們對CymaBay交易完成後的預期。正如Johanna之前提到的，在獲得監管部門批准後，我們預計將在2024年底前在美國推出seladelpar，預計今年將帶來適度的收入貢獻。

Additionally, we have shared that the transaction is expected to add to operating expenses this year as we make incremental investments to support the launch as well as other R&D efforts, all of which we are able to manage within the window of the previously-issued operating expense guidance.

此外，我們已表示，由於需要進行增量投資以支援產品上市以及其他研發工作，預計今年的營運費用將會增加，但所有這些都可以在先前發布的營運費用指導範圍內進行管理。

And as we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be breakeven to earnings in 2025, and significantly accretive in 2026 onwards.

展望未來，雖然該交易將稀釋我們今年的每股收益，但我們預計該交易將在 2025 年實現盈虧平衡，並從 2026 年起顯著增加收益。

And now, I''ll invite Rebecca to begin the Q&A.

現在，我邀請麗貝卡開始問答環節。

(Operator Instructions)

（操作說明）

Our first question comes from Chris Schott at JPMorgan.

我們的第一個問題來自摩根大通的克里斯·肖特。

Just had a question on the HIV franchise and the impact from the Medicare redesign as we think about 2025, I know this is coming in more and more conversations. Can you just talk a little bit about how you're thinking about that impact to your franchise? And maybe just more broadly, can we directionally still think about top line growth and margin expansion for Gilead next year despite this headwind? So any color you can provide there would be appreciated.

我剛剛收到一個關於愛滋病業務以及醫療保險改革對2025年影響的問題，我知道這個問題在討論中越來越常見。您能否簡單談談您如何看待這項改革對貴公司業務的影響？更廣泛地說，儘管面臨這些不利因素，我們是否仍然可以預期吉利德明年的營收成長和利潤率提升？如果您能提供任何相關信息，我們將不勝感激。

Great, Chris. Welcome, everybody. This is Dan. I'm going to have Johanna cover this question. Thank you.

好的，克里斯。歡迎大家。我是丹。這個問題將由喬安娜來回答。謝謝。

Thanks, Chris, for the question. So we do expect an impact of the Part D redesign to be weighted towards our HIV business and expect our HIV growth in 2025 to be offset by the Part D redesign impact. So as a result, we expect our HIV sales to be roughly flat year-on-year in 2025. Having said that, overall, we expect our total business to grow despite the impact of the Part D we designed in 2025 with the top line, building momentum in 2020 -- beyond 2025, right, '26 and beyond. So we do expect growth in '25, but our HIV business, the demand of HIV will offset the impact of Part D.

謝謝Chris的提問。我們預期D部分重新設計對我們的HIV業務影響較大，並預期2025年HIV業務的成長將被D部分重新設計的影響所抵銷。因此，我們預計2025年HIV業務的銷售額將與上年基本持平。儘管如此，總體而言，我們預計儘管受到D部分重新設計的影響，我們的整體業務仍將成長。我們在2025年設計的D部分方案在2020年就已開始累積成長勢頭，並在2025年之後，也就是2026年及以後，維持成長動能。因此，我們預計2025年業務將有所成長，但HIV業務的需求將抵消D部分重新設計的影響。

Chris, it's Andy. I'll take the question on margin expansion. As you know, we don't provide more specific guidance for 2025 beyond what Johanna just mentioned. What we have said historically, and I've underscored, is that we are very focused on disciplined expense management. That will be true in 2025 as it is today. You've seen that in the last 2 quarters. I think on a non-GAAP basis for this quarter, if you look at our operating margin, if you strip out the CymaBay transaction, you see an improvement in our operating margin and we expect that to continue over time. So we do expect broadly for our operating margin to improve over time as you see the continued top line growth and the disciplined expense management. So thanks for the question. More details, of course, to be provided at early next year when we provide our 2025 guidance specifically.

克里斯，我是安迪。我來回答關於利潤率擴張的問題。如你所知，除了喬安娜剛才提到的，我們沒有提供關於2025年的更具體的指引。我們一直以來都強調，我們非常注重嚴格的費用控制。這一點在2025年也會像現在一樣。過去兩個季度你已經看到了這一點。我認為，如果從非GAAP準則來看，剔除CymaBay交易的影響，你會發現本季的營業利潤率有所提高，我們預計這一趨勢會持續下去。因此，隨著營收的持續成長和嚴格的費用控制，我們預期營業利潤率會整體逐步提高。感謝你的提問。當然，我們會在明年初發布2025年業績指引時提供更多細節。

Our next question comes from Daina Graybosch at Leerink Partners.

我們的下一個問題來自 Leerink Partners 的 Daina Graybosch。

It's for Kite. FDA's ODAC recently had 2 important meetings of relevance for multiple myeloma and CAR-T there. One, dealt with the early death risk from CARVYKTI and ABECMA. And the second was to recommend MRD as an intermediate endpoint for accelerated approval in multiple myeloma. And I wonder how you're thinking about both of these ODACs in relation to anito-cel in your earlier line trial design.

這是給Kite的。 FDA的ODAC最近召開了兩次與多發性骨髓瘤和CAR-T療法相關的重要會議。一次會議討論了CARVYKTI和ABECMA的早期死亡風險。另一次會議建議將微小殘留病灶（MRD）作為多發性骨髓瘤加速審批的中期終點。我想知道您在早期臨床試驗設計中，如何看待這兩次ODAC會議與anito-cel之間的關係。

Thanks, Daina. We've got Cindy Perettie here, so we'll go right over to her.

謝謝你，黛娜。辛蒂佩雷蒂也在這裡，我們這就去請她過來。

Thanks, Daina. So if I start off with the early line ODAC, I think we believe this is positive for everybody. What it's shown is that people recognize the value of having CAR Ts therapies earlier in their disease. They value the disease-free intervals that they get from that. So we were very happy to see that. I think we were equally as excited to see the second ODAC around MRD, minimal residual disease, as a secondary -- as an additional endpoint. I think the piece around this is that we're really encouraged that the ODAC decision is going to open up the door for us to potentially bring anito-cel to market faster for patients. And we're in the process right now of understanding how the MRD surrogate endpoint can be used with regulatory agencies and the application of our program and so more to come on that front.

謝謝，Daina。首先，關於早期 ODAC 的結果，我認為這對所有人來說都是利好消息。這表明人們認識到在疾病早期接受 CAR-T 療法的價值，他們重視由此獲得的無疾病生存期。因此，我們對此感到非常高興。同樣令我們興奮的是，第二個 ODAC 也批准了 MRD（微小殘留病灶）這一次要終點。我認為，ODAC 的決定讓我們倍感鼓舞，因為它有望加快我們向患者推出 Anito-Cel 的進程。目前，我們正在研究如何將 MRD 作為替代終點與監管機構進行溝通，以及如何將其應用於我們的計畫申請中，更多相關資訊敬請期待。

Our next question comes from Umer Raffat of Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

I just thought I'll spend a quick second on CymaBay given the recent deal. My question is, did Gilead, during the diligence process, deploy independent pathologists to evaluate the cases of "possible" liver pathology that happened in the NASH trial previously as well as the paired liver biopsy data from the PBC trial at the lower dose where CymaBay didn't think it would need safety adjudication? I'd be very curious how you guys did that and if you would ever publish that.

鑑於最近達成的交易，我想簡單問一下關於CymaBay的問題。我的問題是，在盡職調查過程中，吉利德是否聘請了獨立的病理學家來評估先前NASH試驗中出現的「可能」肝臟病變病例，以及PBC試驗中較低劑量（CymaBay認為無需進行安全性裁定）的配對肝臟活檢數據？我很想知道你們是如何進行評估的，以及你們是否會公佈評估結果。

Merdad is here, so I'll let him answer.

Merdad在這裡，所以讓他來回答。

Thanks, Umer. Let me start by saying we think seladelpar is one of those medicines that will bring a lot of benefit to patients and really some near-term expansion of our liver portfolio and our -- and what we think will synergize with many of the other -- much of the other work that we're doing in liver disease overall.

謝謝，烏默。首先我想說，我們認為seladelpar是那種能為患者帶來許多益處的藥物之一，它能真正擴大我們肝臟產品組合的近期範圍，而且我們認為它還能與我們在肝臟疾病領域開展的其他許多工作產生協同效應。

We obviously did thorough diligence in our approach to seladelpar and CymaBay. We didn't do a third -- I think your question was around whether we did an independent third-party review of the pathology. We did not do that. However, we did a lot of thorough diligence on the data itself and the outcomes. And we are confident around the outcome and what it means for patients over time.

顯然，我們在對seladelpar和CymaBay進行評估時，採取了非常嚴謹的審查方法。我們沒有進行第三方審查——我想您的問題是關於我們是否對病理結果進行了獨立的第三方審查。我們沒有這樣做。但是，我們對數據本身和治療結果進行了非常徹底的審查。我們對治療結果及其對患者的長期影響充滿信心。

Obviously, we're awaiting right now the -- our upcoming PDUFA date and also the file in the EMA, which we are optimistic about. And following the questions and all those sorts of items that we're in. So we're looking forward to providing an update on that as those filings proceed.

顯然，我們目前正在等待即將到來的PDUFA日期以及提交給EMA的文件，我們對後者持樂觀態度。同時，我們也在關注相關問題和其他事項。隨著這些文件的進展，我們將及時提供最新資訊。

Our next question comes from Tyler Van Buren at TD Cowen.

下一個問題來自 TD Cowen 公司的 Tyler Van Buren。

I was hoping you could help set expectations for EVOKE-01 and 02 presentations at ASCO. For EVOKE-02, the late breaker tag is interesting. So is that related to the 3-month OS benefit in the PD-1 refractory patients? Or could we -- or should we be expecting something more? And for EVOKE-02, what should we hope to see with the Cohort A data that should leave us confident in the EVOKE-03 readout next year?

希望您能幫忙分析EVOKE-01和EVOKE-02在ASCO大會上的報告預期。 EVOKE-02的「最新突破」標籤很有意思。這是否與PD-1抗藥性患者的3個月總存活期獲益有關？或者我們可以期待更多？另外，EVOKE-02的A組數據有哪些值得期待的地方，才能讓我們對明年EVOKE-03的公佈充滿信心？

Thanks, Tyler, it's Merdad again here. So it's a little challenging because I can't share too many details now because we're under embargo for both of those. And obviously, happy to fill in a lot of the blanks once the data are released, and we can talk about it in ASCO. I think for EVOKE-01, we think there are a number of pipeline updates in our ASCO presentations that we have upcoming, which were -- we see as a real change for us and a real evolution of our pipeline overall and our ability to build our oncology pipeline and bring new options for patients.

謝謝Tyler，我是Merdad。現在情況有點棘手，因為這兩個項目都處於保密期，我不能透露太多細節。當然，一旦數據公佈，我們很樂意在ASCO會議上詳細討論，屆時我會補充更多資訊。關於EVOKE-01，我們即將在ASCO會議上公佈一些研發管線更新，我們認為這對我們來說是一個真正的變革，也是我們整體研發管線的一次真正發展，它提升了我們構建腫瘤研發管線、為患者帶來新選擇的能力。

As part of the late breaker session for EVOKE-01, as you mentioned, we will include data on overall survival, on PFS, ORR and duration of response as well as the safety profile, of course. And I wish I could give you more details, but I can't at this point. As you say, we will also be providing other updates there, including the EVOKE-02 Cohort A data looking at the PD-L1 high non-small cell population. And again, it's -- I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and talking about the implications of that for our broader lung cancer and especially the frontline lung cancer EVOKE-03 study that we are conducting right now is underway with our partners at Merck.

如您所提到的，在EVOKE-01的最新進展報告中，我們將公佈總存活期、無惡化存活期（PFS）、客觀緩解率（ORR）和緩解持續時間的數據，當然還有安全性數據。我很想提供更多細節，但目前還不方便透露。正如您所說，我們還將提供其他更新訊息，包括EVOKE-02 A組PD-L1高表達非小細胞肺癌族群的數據。再次強調，我無法透露這些數據的具體細節，但我們期待與大家分享這些結果，並探討其對我們更廣泛的肺癌治療，特別是我們目前正在與默克公司合作開展的一線肺癌研究EVOKE-03的意義。

Our next question comes from the line of Geoff Meacham at Bank of America.

我們的下一個問題來自美國銀行的傑夫·米查姆。

Merdad, a question for you. On the cell therapy front, you usually have the anito-cel update later this year, which is big. But beyond that, I wasn't sure what the priority was among the next-gen CAR assets that you've got kind of cartooned on Slide 19. There's a lot of competition in this space, but you guys are among the only players that have real scale and you could move the next-gen stuff, I think, pretty fast. But if you had to pick sort of a priority list, will be good to know.

Merdad，我有個問題想問你。在細胞療法方面，你們通常會在今年稍後發布Anito-Cel的最新進展，這很重要。但除此之外，我不確定你們在第19張投影片上用示意圖展示的下一代CAR-T療法中，優先順序是什麼。這個領域的競爭非常激烈，但你們是少數幾家真正擁有規模優勢的公司之一，我認為你們可以很快地推進下一代療法的研發。但如果你們要列出優先級，我很想知道。

Thanks, Geoff. This is Dan. We're going to have Cindy Perettie answer that question, if you don't mind. So Cindy, over to you.

謝謝，傑夫。我是丹。如果您不介意的話，我們將請辛迪·佩雷蒂回答這個問題。那麼，辛迪，請你發言。

So we have 3 products right now, or 3 constructs that are in Phase Ia and b clinical trials. The first one is a bicistronic CD19, CD20 that has 41BB and CD28. The second one is that same construct with fast manufacturing, 3-day manufacturing. And the other one is a CD19 like Yescarta with 3-day manufacturing. So we're looking at all 3 of those in parallel with the goal of picking the winner to advance that rapidly into our pivotal trials. So that's what's coming up next. Obviously, we've shared a lot around anito-cel as well. With anito-cel, we have the iMMagine-1 readout, and we expect to move quickly into earlier lines as it relates to anito-cel, and you'll hear more about that later this year. Hopefully, that answers your question. We certainly have a number of plays in early research, but we would plan to advance our next-generation lymphoma assets quickly. And obviously, with the scale that we have at Kite as well as the integrated fact that we can create the vector as well as the construct in-house.

目前我們有3種產品，或說3種構建體，正在進行Ia期和Ib期臨床試驗。第一種是雙順反子CD19/CD20，含有41BB和CD28。第二種是同樣的構建體，但生產速度更快，只需3天即可完成。第三種是類似Yescarta的CD19，同樣只需3天即可完成生產。我們正在並行研究這三種產品，目標是選出優勝者，並迅速推進到關鍵性試驗階段。這就是我們接下來的計劃。當然，我們也分享了很多關於anito-cel的資訊。 anito-cel已經獲得了iMMagine-1的讀數，我們預計會迅速推進anito-cel的早期臨床試驗，今年稍後您會聽到更多相關資訊。希望以上解答了您的問題。我們確實有很多早期研究項目，但我們計劃快速推動下一代淋巴瘤資產的研發。顯然，憑藉 Kite 的規模以及我們可以在公司內部創建向量和結構的整合事實。

Our next question comes from Michael Yee at Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

Following up on the Trodelvy data coming at ASCO and your enthusiasm for frontline, can you just remind us, a, do you believe that your data in EVOKE second line that will be at ASCO is at least as competitive or better than Astra, and that is why you're excited about frontline? And b, if you are, do you have a triple therapy on top of chemo combo or is your whole first-line strategy just on top of PD-1?

鑑於Trodelvy在ASCO會議上公佈的數據以及您對一線治療的熱情，能否請您再次說明兩點：a. 您是否認為即將在ASCO會議上公佈的EVOKE二線治療數據至少與阿斯特捷利康（Astra）的二線治療數據相當或更優，而這正是您對一線治療充滿信心的原因？ b. 如果是這樣，您是否在化療聯合方案的基礎上採用了三聯療法，還是您的整個一線治療策略都基於PD-1抑製劑？

Thanks, Michael. This is Merdad again. As we've noted, I think, and as you talked about, the EVOKE-01 data in second line will be something that we discuss at ASCO and show those data. And the full data set is -- does motivate us to go forward in lung cancer and including with discussions with regulators. The unmet need in this population is great, and the data give us options, including discussions with health authorities and conducting follow-up trials. We'll be able to share more once the data are provided at ASCO, and so we look forward to having those deeper discussions once we can speak directly to the data.

謝謝，Michael。我是Merdad。正如我們之前提到的，也正如您所說，EVOKE-01二線治療的數據將在ASCO會議上進行討論並展示。完整的數據集確實激勵我們繼續推進肺癌治療，包括與監管機構進行討論。該族群的未滿足需求龐大，而這些數據為我們提供了多種選擇，包括與衛生部門進行討論以及進行後續試驗。一旦ASCO會議公佈數據，我們將能夠分享更多信息，因此我們期待在能夠直接解讀數據後，進行更深入的討論。

And I'm sorry, and the second part of your question was around the front line. Again, I think once we are able to share the EVOKE-02 data, the update on EVOKE-02 data, we'll be able to talk more. But it does continue to allow us to think about the frontline and our confidence around about EVOKE-03. And then the last part of your question on other combinations. We do think about our intra-portfolio combinations. For example, we have a combination of domvanalimab and Trodelvy in a trial where we're looking to see if we can get additional efficacy from those sorts of combinations. So we do continuously look at our portfolio and look for opportunities for moving the needle with combinations from within our portfolio.

抱歉，您問題的第二部分是關於一線治療的。我認為，一旦我們能夠分享EVOKE-02的數據，也就是EVOKE-02數據的最新進展，我們就可以進行更深入的討論。但這確實讓我們能夠繼續思考第一線治療以及我們對EVOKE-03的信心。至於您問題的最後一部分，關於其他聯合療法，我們確實會考慮我們產品組合內的其他聯合療法。例如，我們正在進行一項試驗，研究domvanalimab和Trodelvy的聯合療法，看看能否從這類聯合療法中獲得額外的療效。因此，我們會持續關注我們的產品組合，並尋找機會透過現有產品組合中的聯合療法來提升療效。

Our next question comes from Salveen Richter of Goldman Sachs.

下一個問題來自高盛的薩爾文·里希特。

So you currently have about $5 billion in cash and noted leverage is back to pre-Immunomedics deal levels. How are you thinking about meaningful or bolt-on BD post the CymaBay acquisition? And is there any preference now between virology, I&I and oncology?

所以你們目前擁有約50億美元的現金，而且槓桿率已經恢復到收購Immunomedics之前的水平。在收購CymaBay之後，你們如何考慮進行實質的業務拓展或補充性業務拓展？目前在病毒學、感染與感染以及腫瘤學領域，你們是否有任何偏好？

Salveen, it's Andy. Maybe I'll start with that one. In our prepared remarks, I highlighted that in the near term, we don't expect sizable M&A.

薩爾文，我是安迪。或許我應該先從這個話題開始。在事先準備好的發言稿中，我強調過，短期內我們預計不會有大規模的併購活動。

So we have a lot of execution ahead of us. We have a deep portfolio, a lot of growth drivers, including seladelpar. So we're very clearly highlighting that in the short term, we will continue to do ordinary course business development, the standard licensing deals. You saw a couple of those in the first quarter. But it's unlikely that we'd pursue any meaningful M&A in the near term. We've also said historically that deals like CymaBay are exactly what we're looking for and that we should do deals like that on a regular basis over the cycle and whether that's every 2 years on average or more or less, that's a general ballpark. So I think you're appropriately highlighting we have -- we generate a lot of operating cash flow. You saw that again in the first quarter. We will rebuild our cash over time. We're going to continue to invest in the pipeline. But at least in the short run, we don't expect any meaningful M&A in the short run.

所以我們還有很多工作要做。我們擁有豐富的產品組合，以及許多成長動力，包括Seladelpar。因此，我們非常明確地強調，短期內，我們將繼續進行常規的業務拓展，進行標準的授權交易。您在第一季已經看到了一些這樣的交易。但我們不太可能在短期內進行任何實質的併購。我們也曾說過，像CymaBay這樣的交易正是我們所尋求的，我們應該在整個週期內定期進行此類交易，平均每兩年一次，或者更頻繁或更短，這只是一個大致的頻率。我認為您強調我們擁有充足的營運現金流這一點非常恰當。您在第一季也看到了這一點。我們將逐步恢復現金流。我們將繼續投資在研產品。但至少在短期內，我們預計不會進行任何實質的併購。

And Salveen, this is Dan. Just to answer the end of your question. I mean, we're always therapeutic area agnostic when we approach these. I mean, first of all, we've got robust portfolios around both virology and oncology and a building portfolio in inflammation. So we look, frankly, across those spectrums. Seladelpar is a great example of finding an opportunity within our liver disease or -- franchise and be able to use that channel. But equally, we'll look for opportunities and synergies that complement our portfolio across therapeutic areas. And that's our approach. We think that makes sense. We look for the most attractive science. And as Andy said, we have a lot in our hands now to work through and to execute on. And so we'll keep the bar very high.

薩爾文，我是丹。我來回答你最後一個問題。我的意思是，我們在處理這些問題時，始終不限於特定的治療領域。首先，我們在病毒學和腫瘤學領域都擁有強大的產品組合，發炎領域的產品組合也在不斷改進。所以坦白說，我們會關注所有這些領域。 Seladelpar 就是一個很好的例子，它體現了我們如何在肝病領域或特許經營權範圍內找到機會，並利用現有管道進行推廣。但同樣地，我們也會尋找能夠補充我們現有治療領域產品組合的機會和綜效。這就是我們的方法。我們認為這是合理的。我們會尋找最具吸引力的科學成果。正如安迪所說，我們現在有很多工作要做，很多事情需要落實。因此，我們會保持高標準。

Our next question comes from James Shin at Deutsche Bank.

下一個問題來自德意志銀行的 James Shin。

I wanted to ask on Trodelvy's efforts in HR+/HER2-. DESTINY-Breast06 is going to have data pretty soon it seems. And you also have ASCENT-07. Sort of sounds similar to DESTINY-Breast04 versus TROPiCS-02. Can you share like how you think this landscape will play out with these 2 trials?

我想問Trodelvy在HR+/HER2-乳癌領域的研究進展。 DESTINY-Breast06試驗的數據似乎很快就會公佈。此外，你們還有ASCENT-07試驗。這聽起來有點像DESTINY-Breast04和TROPiCS-02的對比。能否分享一下您對這兩項試驗最終結果的看法？

Thanks for the question, James. Well, it's -- I've learned to try to keep away from prognostication. So that's harder to do. We -- look, maybe the way I would put it is we are proud of the fact that Trodelvy is still the only TROP2 ADC that is approved, and that is in large part driven by the important role that Trodelvy plays in breast cancer right now for patients. And we do continue to want to push that, along with the ASCENT-07. We have a number of other trials ongoing to expand our footprint in breast cancer. I think we are right now in TNBC, the leading regimen.

謝謝你的提問，James。嗯，我一直努力避免做出預後判斷。所以現在更難做到了。我們－或許我應該這麼說：我們很自豪Trodelvy至今仍是唯一獲準的TROP2抗體偶聯藥物（ADC），這很大程度歸功於Trodelvy目前在乳癌治療領域對病人的重要角色。我們確實希望繼續推進Trodelvy的研發，以及ASCENT-07試驗。我們還有許多其他試驗正在進行中，以擴大我們在乳癌領域的應用。我認為我們目前在三陰性乳癌（TNBC）領域處於領先地位。

And as we are continuing to advance our HR+/HER2- and in particular, in the IHC-0 population, I think we remain confident around our place there. We've shown a benefit in randomized clinical trials there, and that's been the basis for our regulatory filings and approvals. So I don't think we can assume success. We'll have to see what the data are. But looking forward into the year that's coming with ASCENT-03 coming up, I think that will provide us additional information to further expand our potential in breast cancer. Johanna, do you want to add?

隨著我們不斷推進HR+/HER2-，特別是IHC-0人群的研究，我認為我們仍然對我們在該領域的地位充滿信心。我們在隨機臨床試驗中已經證明了該療法的益處，這也是我們提交監管申請和批准的基礎。所以我認為我們不能想當然地認為一定會成功。我們還需要觀察數據。但展望即將到來的ASCENT-03試驗，我認為它將為我們提供更多信息，從而進一步拓展我們在乳癌領域的潛力。 Johanna，你還有什麼要補充的嗎？

Maybe just to add to that. I would also say that the more options these patients have, these women have, in HR+ in earlier lines of therapy instead of cycling through chemotherapies, the better. So with DB06 results and moving potentially that compound up earlier, it actually allows for Trodelvy to also play a more important and a bigger population than it is today because of the profile of the TROPiCS-02 label. And so we do believe that there's opportunities for this TROP2 ADC to move up and also differentiate itself versus other ADCs in this marketplace, depending on the side effect profile, the safety profile, not only on the efficacy. And so in light of the IHC-0 setting being really our strong foothold in HR+/HER2-, we believe that will continue, whether that's in later lines of therapy or earlier lines as these studies play out.

或許我還要補充一點。對於這些HR+患者，尤其是女性患者來說，在早期治療階段擁有更多選擇，而不是反覆接受化療，當然更好。 DB06研究的結果以及該化合物可能更早接受治療，實際上使得Trodelvy能夠涵蓋比現在更重要、更廣泛的患者群體，這得益於TROPiCS-02標籤所展現出的特性。因此，我們相信，這款TROP2抗體偶聯藥物(ADC)不僅在療效方面，而且在副作用和安全性方面，都有可能在市場上脫穎而出，與其他ADC藥物區分開來。鑑於IHC-0階段是我們目前在HR+/HER2-患者群體中的優勢所在，我們相信，隨著這些研究的進行，無論是在後續治療階段還是早期治療階段，這一優勢都將繼續保持。

Our Next question comes from Mohit Bansal, Wells Fargo.

下一個問題來自富國銀行的莫希特·班薩爾。

Maybe a big picture question, if you think about medium to longer term because, I mean, yes, you do not have an LOE. But I mean, HIV growth is somewhere around mid, low single digits. And oncology, I mean, again, I mean, it dropped too and all. The expansion opportunities seem limited at this point. So just trying to understand how do you turn this low single digit to more like a high single-digit kind of growth for overall company? CymaBay is definitely an addition, but how are you thinking about it from medium to long term, which probably people like us are missing?

或許這是一個著眼於大局的問題，需要從中長期角度來考慮，因為，是的，你們沒有業績報告。但我的意思是，HIV業務的成長大概在個位數中低段。腫瘤業務也是如此，同樣，成長也出現了下滑。目前來看，擴張機會似乎有限。所以，我只是想了解，如何才能將這種個位數低段的成長提升到接近個位數的水平，從而帶動公司整體成長？ CymaBay無疑是一個不錯的補充，但你們是如何看待它的中長期發展的呢？這或許正是我們這類人所忽略的。

Mohit, maybe I'll start and then have others add. First of all, I think just stepping back and thinking about the portfolio that we've built over the past 4 years now more than doubling the size of the portfolio and with significant advances in our HIV portfolio and oncology and with outside of cell therapy. So as we think about growth moving forward, I mean, first of all, I would say on the HIV side of the business, we have to constantly remind ourselves and others that in addition to the treatment market and the potential for long-acting treatment that we have a very robust program on, and we'll update you a little bit more on towards the second half of this year with an analyst event, we've got the PrEP market that is just beginning to kind of be dimensionalized.

莫希特，或許我先來，然後其他人再補充。首先，我想回顧過去四年我們建立的產品組合，如今產品組合規模已擴大了一倍多，我們在愛滋病產品組合、腫瘤學以及細胞療法以外的領域都取得了顯著進展。展望未來，我認為，首先，就愛滋病業務而言，我們必須不斷提醒自己和他人，除了治療市場以及我們擁有非常強大的長效治療計畫（我們將在今年下半年的分析師會議上提供更多相關資訊）之外，我們的PrEP市場也正處於起步階段。

And that is -- I think that provides significant growth opportunity when you think about your time frame, which you mentioned, which is until the end of the decade. So I think it allows us to think about accelerated HIV total growth prevention and treatment as we head towards the second half of the decade. That -- on top of that, then we have the entirety of the oncology portfolio. So both cell therapy within the large B-cell lymphoma area as well as potentially the multiple myeloma entry with the anito-cel. And then on top of that, a very robust oncology portfolio that has both Trodelvy and other novel agents that we'll read out over the course of this decade. And I'll just remind you, again, we've got close to 20 readouts this year, of which 3 of those are in Phase III, including lenacapavir for prep in the second half of this year, 2 Trodelvy Phase III readouts. And then importantly, we've added seladelpar to the mix with a PDUFA date in August.

我認為，考慮到您提到的時間框架（即到本十年末），這提供了巨大的成長機會。因此，我認為這使我們能夠在進入本十年後半段時，著眼於加速愛滋病毒預防和治療的整體成長。除此之外，我們還有完整的腫瘤產品組合。包括大B細胞淋巴瘤領域的細胞療法，以及可能透過anito-cel進入多發性骨髓瘤領域的藥物。此外，我們還有一個非常強大的腫瘤產品組合，其中包括Trodelvy和其他一些我們將在本十年內公佈結果的新型藥物。我再次提醒您，我們今年將公佈近20項研究結果，其中3項處於III期臨床試驗階段，包括今年下半年公佈的用於治療的lenacapavir，以及兩項Trodelvy的III期臨床試驗結果。更重要的是，我們也新增了seladelpar，其PDUFA日期定於8月。

And then finally, just the opportunity to update you on the anito-cel at the end of the year as well. So we'll be providing more guidance as we continue to look at the entirety of our portfolio, but we really think we have within the company today, by the way, I'll just mention, in addition to complementing where needed from the outside. But within the company today, we have what it takes to drive a substantial growth in our business over the course of the next decade with focus on expense management as well to produce good returns for investors.

最後，年底的時候，我還想藉此機會向大家報告anito-cel的情況。我們會繼續審視整個投資組合，並提供更多指導。順便提一下，我們公司目前擁有足夠的實力，除了在需要時從外部進行補充之外，我們有能力在未來十年內推動業務實現顯著增長，同時注重成本控制，從而為投資者帶來良好的回報。

Our next question comes from Simon Baker at Redburn Atlantic.

我們的下一個問題來自 Redburn Atlantic 的 Simon Baker。

One on seladelpar, if I may. And a question really around the competitive dynamics at launch. If all goes according to plan, your launch in August and Ipsen will launch Elafibranor in June. So I was just wondering if that really makes any difference. You've obviously got far greater infrastructure than Ipsen. Is it too early for them to steal in March? Or paradoxically thus having somebody else on the market promoting PBC actually raise disease awareness and help the situation? So any color around the dynamics at launch would be very helpful.

請問關於seladelpar，如果可以的話。另外還有一個關於上市初期競爭格局的問題。如果一切按計畫進行，你們的藥物將於8月上市，而Ipsen將在6月上市Elafibranor。我想知道這是否真的會造成影響。你們的基礎設施顯然比Ipsen強大得多。他們3月搶先上市會不會太早？或者，矛盾的是，市場上出現其他品牌推廣PBC反而會提高人們對這種疾病的認識，有助於改善現狀？所以，任何關於上市初期競爭格局的資訊都將非常有幫助。

Thanks, Simon. It's Johanna. Let me take that one. And I think you're absolutely right. I think the fact that there is more than one competitor hitting the market is great for patients namely around increasing disease awareness around PBC and the fact that there are 2 options available. Having said that, I also feel incredibly confident that seladelpar is well differentiated to potentially be best in disease when you think about the significant impact and clinically meaningful impact we have with the ALP normalization in the clinical jet Phase III clinical trial we've seen as well as the improvement in pruritus which is a key symptom of the disease. And today, there really is no effective antipruritic options for PBC patients. And so all of that put together, in addition to the fact that we believe our footprint, both commercial and medical is incredibly well established when it comes to liver disease. It already covers about 80% of all U.S. PBC prescribers. And with that strong differentiated profile we were just referring to, I don't think those 3 months make a difference. I think really it's about best-in-class launch and that potential with seladelpar that we look forward for our PDUFA date.

謝謝，西蒙。我是喬安娜。讓我來回答這個問題。我認為你說得完全正確。我認為市場上出現不只一個競爭對手對患者來說是件好事，尤其是在提高人們對原發性膽汁性膽管炎（PBC）的認知度以及提供兩種治療選擇方面。話雖如此，我仍然非常有信心，考慮到我們在臨床JET III期臨床試驗中觀察到的ALP正常化方面的顯著且具有臨床意義的影響，以及瘙癢症狀（該疾病的關鍵症狀）的改善，seladelpar具有很強的差異化優勢，有可能成為治療該疾病的最佳選擇。目前，PBC患者確實沒有有效的止癢藥物。綜上所述，再加上我們相信我們在肝病領域的商業和醫療佈局已經非常穩固。我們的產品已經涵蓋了美國約80%的PBC處方醫生。憑藉我們剛才提到的這種強大的差異化優勢，我認為這三個月的等待時間不會造成任何影響。我認為真正重要的是實現一流的上市，以及 seladelpar 所蘊含的潛力，我們期待著我們的 PDUFA 日期到來。

Our next question comes from Brian Skorney at Baird.

我們的下一個問題來自 Baird 公司的 Brian Skorney。

This is Charlie on for Brian. So again, to ask something about seladelpar. Just wondering if you have any ambitions for potentially looking at a label for first line in the future, considering there's a lot of unmet need with pruritus there. As well as any potential synergies you may be considering with the remainder of your liver portfolio?

我是查理，替布萊恩問。我還是想問一下關於seladelpar的問題。考慮到搔癢症方面存在著許多未被滿足的需求，我想知道你們未來是否有可能考慮將其作為第一線治療藥物。另外，你們是否也在考慮將其與肝臟疾病產品組合中的其他藥物進行協同增效？

Thanks, Charlie. This is Merdad. Frontline is a challenge given the -- what is currently the background standard of care. But as you know, we think that seladelpar is going to bring a lot of benefit to a lot of patients, especially given the pruritus and the potential for getting to patients earlier in their course will be really important for us. And so we have to see how the market starts to respond to the presence of seladelpar in the second line. And recall, I think the other thing to recall or think about is the -- how long people actually get frontline therapy before moving on to second-line therapy, given the efficacy profile of the frontline therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and making -- moving up formally for registrational trials to the frontline potentially superfluous. So I think we'll see how that plays out in the market. And once we see our label and all those sorts of things, so we'll be able to update more after that.

謝謝，查理。我是默達德。鑑於目前的標準治療方案，一線治療確實面臨挑戰。但正如您所知，我們認為塞拉德帕（seladelpar）將為眾多患者帶來益處，尤其是在緩解搔癢方面。能夠更早為患者提供治療對我們來說至關重要。因此，我們需要觀察市場對塞拉德帕作為二線治療藥物的反應。另外，我認為還需要考慮的是，考慮到一線治療的療效以及目前尚無其他選擇，患者在接受一線治療後實際需要多長時間才能轉為二線治療。我們可以預見，患者會在治療早期就轉為二線治療，因此，正式註冊試驗中升級到第一線治療可能顯得多餘。所以，我想我們會觀察市場反應。一旦我們拿到藥品說明書等相關信息，之後我們會提供更多更新。

Our next question comes from Brian Abrahams at 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。

PURPOSE 1 is obviously an upcoming readout. So I wanted to clarify some elements of its unique design, specifically what's the sensitivity of assessing when HIV infection occurred to accurately project the control infection rate? And then how do you control for potential intrinsic differences in risk behavior that the screened out group serving as the control may have versus individuals who are -- who make it into the trial?

目的 1 顯然是即將公佈的結果。所以我想澄清一下其獨特設計中的一些要素，特別是評估 HIV 感染發生時間以準確預測對照組感染率的敏感性如何？此外，如何控製作為對照組的篩選族群與最終入組試驗的個體之間可能存在的內在風險行為差異？

Brian, thanks, it's Merdad again. And I could talk about this for a long time. Let me -- I'll try to give a very concise answer. The recency assay that's been developed for HIV, it has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who's potentially HIV infected at that time as to how recently they were infected. And I think that's a key part. And that relates to the second part of your question in that the -- we don't, in a sense, need to compare risk behaviors before and after randomization and that we'll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design with what happens after people start therapy. So I think between those 2 elements and all the discussions we've had with the regulators and the experts in the field, we're confident in that the design will provide the information necessary to get us to approval and for adoption.

布萊恩，謝謝，我是默達德。關於這個主題我可以講很久。讓我——我盡量給出簡潔的回答。針對愛滋病毒開發的近期感染檢測方法已經過非常深入的研究，我們可以根據篩檢時的診斷結果，為當時可能感染愛滋病毒的人建立感染近期情況的檔案。我認為這是關鍵。這與您問題的第二部分相關，因為——從某種意義上說，我們不需要比較隨機分組前後的風險行為，我們將關注篩檢時愛滋病毒的總體感染率，然後在這種反事實設計中將其與人們開始治療後的情況進行比較。因此，我認為，結合這兩個要素以及我們與監管機構和該領域專家的所有討論，我們有信心，該設計將提供必要的信息，使我們獲得批准並得到應用。

Our next question comes from Terence Flynn at Morgan Stanley.

下一個問題來自摩根士丹利的特倫斯·弗林。

Great. Two parts on the CAR-T franchise. So just was wondering, high level, your commitment to anito-cel if it proves there is parkinsonism, so meaning it's less differentiated. And then the second part is, curious where your progress stands with respect to developing the CAR-T for immunology. Obviously, a lot of focus here amongst a number of other companies in the industry. So just curious on Gilead's thoughts on the forward.

好的。關於CAR-T療法，我想問兩點。首先，我想了解一下，如果Anito-Cel能夠證實帕金森氏症候群的治療效果（也就是說，它的特異性較低），貴公司對Anito-Cel的投入程度如何？其次，我想了解貴公司在CAR-T療法應用於免疫學領域的研發進展。顯然，業內很多公司都在關注這個領域。所以我想了解吉利德公司對未來發展的看法。

Thanks, Terence, for the question. So on the commitment to anito-cel, we're -- as it relates to Parkinson's, we absolutely feel that we're differentiated potentially on both safety and efficacy. As we noted earlier, we have not observed the neurotox that some of the other constructs have observed, and we'll continue to monitor it, but we feel great about the profile right now. And then the efficacy profile, early signals are we think we will be equivalent or could be best-in-class. So we're 100% behind anito-cel and we're looking forward to bringing those data soon.

謝謝 Terence 的提問。關於 anito-cel 的研發，就帕金森氏症而言，我們絕對相信我們在安全性和有效性方面都具有顯著優勢。正如我們之前提到的，我們尚未觀察到其他一些藥物所表現出的神經毒性，我們會繼續監測，但目前我們對它的整體情況非常滿意。至於療效方面，初步跡象表明，我們認為我們的產品將與同類產品相當，甚至可能成為最佳選擇。因此，我們對 anito-cel 充滿信心，並期待盡快公佈相關數據。

The second question around autoimmune space. So we continue to monitor the autoimmune space. And as you've heard from Andy and others before, we will play in that space. We are taking time to take a look at what's in the space versus what we have in our portfolio, and we'll be -- I don't have any updates further than that today.

關於自體免疫領域，第二個問題。我們會繼續關注自身免疫領域。正如您之前從安迪和其他人那裡了解到的，我們將涉足這個領域。我們正在花時間研究該領域的現有項目，並與我們投資組合中的項目進行比較。今天我沒有更多更新資訊。

Our last question comes from Carter Gould at Barclays.

最後一個問題來自巴克萊銀行的卡特·古爾德。

Maybe just to round things out on cell therapy, you flagged the same dynamics that have been kind of persisting in the U.S. as far as the -- some of the constraints of the ATCs. I also saw the Tennessee oncology reference. But I guess putting that all together, just your level of confidence you sort of hit that return to more meaningful growth in the second half of the year. I didn't hear that mentioned and clearly, that's a point of focus. Any commentary there would be appreciated.

或許為了更全面地闡述細胞療法，您提到了美國目前仍然存在的一些問題，例如ATC（美國腫瘤中心）的限制。我還看到了您提到的田納西州腫瘤學。但我想綜合所有因素，您認為下半年細胞療法能夠恢復到更顯著的增長水平，這一點我並沒有聽到您提及，顯然，這是您關注的重點。如果您能就此發表一些看法，我將不勝感激。

Yes. No, we feel very confident that we're going to return to growth in the second half of the year, as we stated. I think just as a reminder, we had shared in quarter 4 our guidance was that we'd be flat to slightly down in quarter 1. And part of that is due to the restructure. So we are putting our strategy into play. We feel very confident about the approach we're taking in the U.S. And we now are looking at having almost a fully stacked sales team back out and working hard. I think a piece that we need to talk about as well as the market dynamics. So the things we're observing. We're observing out-of-class competition with the bispecifics, the ATC constraints that we've spoken about in the past based on multiple myeloma constructs coming in. But what we're seeing is a lot of the hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.

是的。正如我們之前所說，我們非常有信心在下半年恢復成長。我想再次提醒大家，我們在第四季曾預測第一季業績將持平或略有下降。部分原因是由於重組。因此，我們正在實施我們的策略。我們對在美國採取的策略非常有信心。現在，我們正期待著幾乎完整的銷售團隊回歸並全力以赴。我認為我們還需要談談市場動態。我們觀察到，雙特異性抗體藥物帶來了非同類競爭，以及我們先前提到的基於多發性骨髓瘤藥物的ATC限制。但我們看到，許多醫院和ATC正在努力克服這些限制，我們對今年下半年充滿信心。

Thank you, Cindy. This is Dan again. So I appreciate all of you joining. Maybe just a bit of a summary statement. I want you all to know we at Gilead are very focused on the near-term execution and the long-term plans. We'll continue to stay disciplined and agile in our approach. Just as highlights, we've got 54 active clinical programs, no major patent expiries through the end of the decade, a variety of opportunities for growth and a lot more to deliver. On top of that, we are on track to provide updates from 3 Phase III clinical trials for Trodelvy, lenacapavir. We've got the seladelpar PDUFA date in August. Any update on the anito-cel Phase II update with iMMagine-1 at the end of the year. So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jacquie for closing comments.

謝謝Cindy。我是Dan，再次感謝各位的參與。我先簡單總結一下。我想讓大家知道，吉利德非常注重近期執行和長期規劃。我們將繼續保持嚴謹、靈活的工作方式。重點是，我們目前有54個活躍的臨床項目，十年內沒有重大專利到期，擁有各種成長機會，還有更多成果等待實現。此外，我們正在按計劃公佈Trodelvy（lenacapavir）三項III期臨床試驗的最新進展。 seladelpar的PDUFA日期定於8月。 anito-cel II期臨床試驗（iMMagine-1）的最新進展將在年底公佈。請大家放心，我們正全力以赴把握眾多機遇，並且擁有更大的潛力去實現更多目標。接下來，我將把發言權交給Jacquie，請她做總結發言。

Thank you, Dan. To close, just one housekeeping item. I can share that we are tentatively planning to release our second quarter 2024 earnings results on Thursday, August 8. Please note that this is day is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of the second quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we'll close our call for today. Thank you.

謝謝丹。最後，還有一件事要說明。我們可以告知大家，我們暫定於8月8日（星期四）發布2024年第二季財報。請注意，此日期為暫定，可能會根據屆時可能出現的日程衝突進行調整。我們將一如既往地在第二季結束後公佈最終的發布日期。感謝您一直以來對吉利德的關注，我們期待在本季持續向您報告我們的進展。今天的電話會議到此結束。謝謝。