吉利德科學 (GILD) 2025 Q1 法說會逐字稿

Good afternoon everyone. Welcome to Gilead's first-quarter 2025 earnings conference call.

大家下午好。歡迎參加吉利德 2025 年第一季財報電話會議。

My name is Rebekah. I'll be today's host. (Operator Instructions)

我的名字是麗貝卡。我擔任今天的主持人。（操作員指示）

I'll now hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.

我現在將電話交給財務和投資者關係高級副總裁 Jacquie Ross。

Thank you, Rebekah.

謝謝你，麗貝卡。

Just after market close today, we issued a press release with earnings results for the first quarter of 2025. 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，我們發布了一份新聞稿，公佈了 2025 年第一季的獲利結果。新聞稿、投影片和補充資料可在我們網站 gilead.com 的投資者部分找到。

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, Dietmar Berger; 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是我們的董事長兼執行長 Daniel O'Day；我們的商務長 Johanna Mercier；我們的首席醫療官 Dietmar Berger；以及我們的財務長 Andrew Dickinson。之後，我們將進入問答環節，Kite 執行副總裁 Cindy Perettie 將加入團隊。

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.

讓我提醒您，我們將做出前瞻性陳述。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會導致實際結果大不相同。

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

說完這些，我就把電話轉給丹。

Thank you, Jacquie. Good afternoon, everyone.

謝謝你，杰奎。大家下午好。

I'm pleased to share our first-quarter results, which reflect strong commercial and clinical execution across the business.

我很高興分享我們的第一季業績，這反映了整個業務強勁的商業和臨床執行力。

Our base business, excluding Veklury, grew 4% from the first quarter of 2024, primarily driven by growth in our HIV business. HIV sales were up 6% year over year, with Biktarvy up 7%, highlighting our demand-led volume growth that was offset, in part, by the expected headwinds associated with the Part D redesign.

我們的基礎業務（不包括 Veklury）較 2024 年第一季成長了 4%，這主要得益於我們的 HIV 業務的成長。HIV 銷售額年增 6%，其中 Biktarvy 成長 7%，突顯了我們的需求主導的銷售成長，但這一成長在一定程度上被與 D 部分重新設計相關的預期阻力所抵消。

Livdelzi continues its strong launch momentum, with $40 million in sales in its second full quarter, since launch. Year-over-year growth in our HIV and liver disease businesses was partially offset by softer-than-expected Trodelvy sales, due to inventory dynamics that masked increase in demand, as well as headwinds in cell therapy.

Livdelzi 延續了其強勁的上市勢頭，自上市以來的第二個完整季度銷售額達到 4000 萬美元。由於庫存動態掩蓋了需求的增長以及細胞療法的阻力，我們的愛滋病毒和肝病業務的同比增長被 Trodelvy 銷售額低於預期所部分抵消。

Total product sales, including Veklury, were down by 1% from last year, reflecting fewer COVID-19-related hospitalizations.

包括 Veklury 在內的產品總銷售額較去年下降了 1%，反映出與 COVID-19 相關的住院人數減少。

Beyond our commercial results, we also saw impressive operational execution, with strong operating margin and earnings per share results that highlight our continued focus on expense management and leverage in our business model.

除了商業成果之外，我們還看到了令人印象深刻的營運執行，強勁的營業利潤率和每股盈餘結果凸顯了我們繼續專注於業務模式中的費用管理和槓桿作用。

Our diverse pipeline continues to deliver across HIV, oncology, and inflammation.

我們多樣化的研發管線將繼續涵蓋愛滋病毒、腫瘤學和發炎領域。

In HIV, we are now only weeks away from the anticipated FDA decision on twice-yearly lenacapavir for PrEP. We remain on track for the June 19-PDUFA date and the potential launch in the US immediately following.

在愛滋病毒方面，現在我們距離 FDA 就每年兩次使用利那帕韋作為 PrEP 藥物做出預期決定只有幾週的時間了。我們仍按計劃於 6 月 19 日 PDUFA 日期上市，並可能隨即在美國推出該產品。

As a reminder, this is one of up to nine potential HIV product launches we are targeting before the end of 2033, building on Gilead's decades of leadership in HIV innovation.

提醒一下，這是我們計劃在 2033 年底之前推出的多達九種潛在 HIV 產品之一，這將鞏固吉利德數十年來在 HIV 創新領域的領導地位。

In oncology, earlier this week, we announced the positive results from the Phase 3 ASCENT-04 study of Trodelvy, in combination with pembrolizumab, for first-line PD-L1+ metastatic triple negative breast cancer. The results showed a clinically meaningful and statistically significant improvement in progression-free survival over the standard of care.

在腫瘤學領域，本週早些時候，我們宣布了 Trodelvy 與 pembrolizumab 聯合治療一線 PD-L1+ 轉移性三陰性乳癌的 3 期 ASCENT-04 研究的積極結果。結果顯示，與標準治療相比，無惡化存活期具有臨床意義和統計學意義的改善。

This news represents an important potential benefit for patients. Metastatic TNBC is one of the most aggressive forms of breast cancer and has historically been very difficult to treat.

這項消息對病人來說代表著重要的潛在利益。轉移性三陰性乳癌是最具侵襲性的乳癌之一，歷史上一直很難治療。

We expect to share the ASCENT-04 data at a medical congress in the near future and to file with global regulatory authorities, as quickly as possible.

我們希望在不久的將來的醫學大會上分享 ASCENT-04 數據，並儘快向全球監管機構提交。

We continue to expect an update, later this quarter, on the Phase 3 ASCENT-03 study, evaluating Trodelvy monotherapy in first-line metastatic triple negative breast cancer patients, who are not candidates for PD-1 inhibitors.

我們繼續期待本季稍後對 3 期 ASCENT-03 研究的更新，該研究評估了 Trodelvy 單一療法對一線轉移性三陰性乳癌患者（不適合使用 PD-1 抑制劑）的效果。

Moving to cell therapy, we plan to provide an update on our registrational Phase 2 iMMagine-1 trial later this year and remain on track to potentially launch anito-cel in late-line relapse or refractory multiple myeloma in 2026.

在細胞療法方面，我們計劃在今年稍後提供註冊第 2 階段 iMMagine-1 試驗的最新進展，並預計在 2026 年推出用於治療晚期復發或難治性多發性骨髓瘤的 anito-cel。

We believe that anito-cel's clinical profile combined with Kite's exceptional manufacturing capabilities and industry-leading turnaround time, puts us in a strong position to address the unmet need for patients with multiple myeloma.

我們相信，anito-cel 的臨床特性加上 Kite 卓越的製造能力和業界領先的周轉時間，使我們有能力滿足多發性骨髓瘤患者未滿足的需求。

In inflammation, we are launching Livdelzi in additional markets, following approval from the European Commission in February. We look forward to continued momentum as we bring Livdelzi to more people seeking to manage their primary biliary cholangitis with a differentiated option.

此外，繼二月獲得歐盟委員會批准後，我們將在其他市場推出 Livdelzi。我們期待繼續保持這一勢頭，將 Livdelzi 帶給更多尋求透過差異化選擇治療原發性膽汁性膽管炎的患者。

As we wrap up a strong first-quarter performance, we can look forward to continuing positive momentum. We have multiple potential launches ahead, including lenacapavir, anito-cel; and now Trodelvy.

隨著我們結束第一季的強勁表現，我們可以期待繼續保持積極的勢頭。我們有多個潛在的上市產品，包括 lenacapavir、anito-cel；現在是 Trodelvy。

As a reminder, we have no major LOEs until the end of 2033 and expect to drive top-line growth, over time, across all three of our therapeutic focus areas of virology, oncology, and inflammation.

提醒一下，直到 2033 年底我們都沒有重大的 LOE，並且預計隨著時間的推移，我們將在病毒學、腫瘤學和發炎這三個治療重點領域推動營收成長。

The overall strength of our business means we are well positioned to adapt to a range of potential policy outcomes in the United States.

我們業務的整體實力意味著我們能夠很好地適應美國的一系列潛在政策結果。

It is worth noting that Gilead's average corporate tax rate of approximately 20% reflects the fact that the substantial majority of our intellectual property is already registered in the United States. The 2017 tax reform was instrumental in us bolstering our US investment. And Gilead is differentiated in that almost 100% of our R&D capital infrastructure is in the US.

值得注意的是，吉利德的平均企業稅率約為 20%，這反映了我們的絕大部分智慧財產權已在美國註冊的事實。2017 年的稅改對我們加強美國投資扮演了重要角色。吉利德的不同之處在於，我們幾乎 100% 的研發資本基礎設施都在美國。

In addition, we have been increasing our investment in US manufacturing over the last several years, with two large-scale cell therapy sites. And we have additional investment projects underway that are expected to run through 2028.

此外，過去幾年我們一直在增加對美國製造業的投資，並建立了兩個大型細胞治療基地。我們還有其他投資項目正在進行中，預計將持續到 2028 年。

Our focus is on delivering on our multiple upcoming launches and advancing our diverse pipeline, and in the meantime, we continue to engage with the administration to encourage a balanced policy agenda that prioritizes innovation and the needs of patients.

我們的重點是推出即將推出的多個產品並推進我們多樣化的產品線，同時，我們將繼續與政府合作，以鼓勵制定優先考慮創新和患者需求的平衡政策議程。

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

說完這些，我就把它交給約翰娜。

Thanks, Dan. Good afternoon, everyone.

謝謝，丹。大家下午好。

We've had a solid start to the year, with our commercial execution delivering strong year-over-year sales growth in our base business.

我們今年開局良好，商業執行力強勁，基礎業務銷售額年增。

Product sales, excluding Veklury, of $6.3 billion were up 4% year over year, primarily driven by HIV and liver disease sales, partially offset by lower oncology sales. Sequentially, sales were down 12%, as expected, mainly due to inventory dynamics, partially offset by higher sales in liver disease. Total product sales of $6.6 billion were down 1% year over year and 12% sequentially, reflecting lower Veklury sales.

不包括 Veklury 的產品銷售額為 63 億美元，年成長 4%，主要受 HIV 和肝病銷售額的推動，但腫瘤學銷售額的下降部分抵消了這一增長。與上一季相比，銷售額下降了 12%，符合預期，主要原因是庫存動態，但肝病銷售額的增加部分抵消了這一影響。總產品銷售額為 66 億美元，年減 1%，季減 12%，反映 Veklury 銷售額下降。

Moving to slide 8, our HIV business delivered sales of $4.6 billion, up 6% year over year, driven by higher average realized price and higher demand. Sequentially, sales were down 16%, consistent with our guidance, reflecting normal first-quarter seasonality, including lower average realized price and volume, following a particularly strong fourth quarter as well as the impact of Medicare Part D Redesign.

轉到第 8 張投影片，我們的 HIV 業務實現了 46 億美元的銷售額，年增 6%，這得益於平均實現價格的上漲和需求的增加。與上一季相比，銷售額下降了 16%，與我們的預期一致，反映了第一季的正常季節性因素，包括第四季度表現尤為強勁之後的平均實現價格和銷量下降，以及醫療保險 D 部分重新設計的影響。

As a reminder, quarterly HIV growth is generally more variable and less indicative of overall trends than full-year results, with normal first-quarter impacts including inventory drawdown, following a build in the fourth quarter; and channel dynamics, including the resetting of patient co-pays and deductibles, which result in lower average realized price.

需要提醒的是，與全年結果相比，季度愛滋病毒成長通常更具可變性，且不太能代表總體趨勢，第一季度的影響正常，包括庫存下降，隨後是第四季度的增加；以及通路動態，包括重新設定患者共同支付和免賠額，從而降低平均實現價格。

Beyond these typical first-quarter dynamics, HIV revenues were also impacted by Medicare Part D Redesign in the first quarter of 2025. This increased the manufacturer contribution and includes individuals on low-income subsidy for the first time.

除了這些典型的第一季動態之外，2025 年第一季的醫療保險 D 部分重新設計也對 HIV 收入產生了影響。這增加了製造商的貢獻，並首次將低收入補貼納入其中。

While we are still in the early stages of this implementation, our assumptions remain unchanged. In the meantime, we continue to expect robust demand-led volume growth for the full year. Though, as shared back in February, this will be obscured this year, due to Part D headwinds, resulting in flat reported HIV sales, overall, for 2025, with a return to growth in 2026.

雖然我們仍處於實施的早期階段，但我們的假設保持不變。同時，我們仍預期全年銷售將因需求強勁而成長。不過，正如 2 月所分享的那樣，由於 D 部分阻力的影響，今年這一情況將變得模糊，導致 2025 年 HIV 銷售額總體持平，2026 年將恢復增長。

On slide 9. In HIV treatment, the Biktarvy sales of $3.1 billion were up 7% year over year, primarily driven by higher demand. Sequentially, sales were down 17%, as we expected, reflecting first-quarter seasonality, including lower average realized price and volume.

在第 9 張投影片上。在愛滋病治療領域，Biktarvy 的銷售額達 31 億美元，年成長 7%，主要受需求成長的推動。與上一季相比，銷售額下降了 17%，正如我們預期的那樣，這反映了第一季的季節性因素，包括平均實現價格和銷量的下降。

Biktarvy, once again, increased US market share in the first quarter to 51%, outpacing the growth of alternative regimens and remains the regimen of choice across G9 markets. Overall, the HIV treatment market continues to grow in line with our expectations of 2% to 3%, annually.

Biktarvy 在第一季再次將美國市佔率提升至 51%，超過了替代療法的成長速度，並且仍然是 G9 市場的首選療法。總體而言，愛滋病治療市場繼續按照我們預期每年增長 2% 至 3%。

Descovy's sales of $586 million increased 38% year over year, primarily driven by higher average realized price and higher demand. HIV prevention continues to represent the significant majority of Descovy sales.

Descovy 的銷售額為 5.86 億美元，年增 38%，主要得益於平均實現價格上漲和需求增加。HIV 預防仍佔 Descovy 銷售額的絕大部分。

And growth this quarter was driven by broader awareness, growing unrestricted access, and associated pricing favorability, as well as focused commercial execution that contributed to approximately 16% US PrEP market growth year over year.

本季的成長得益於更廣泛的認知、不斷增長的不受限制的訪問和相關的定價優惠，以及有針對性的商業執行，這些因素促使美國 PrEP 市場同比增長約 16%。

Additionally, Descovy maintains over 40% market share and grew more than 2% year over year. Sequentially, sales were down 5%, reflecting typical seasonal inventory dynamics, partially offset by higher average realized price and higher demand.

此外，Descovy 保持超過 40% 的市場份額，並且同比增長超過 2%。銷售額環比下降 5%，反映了典型的季節性庫存動態，但平均實現價格上漲和需求增加部分抵消了下降。

Growing awareness and adoption of HIV prevention is encouraging ahead of our upcoming potential US launch of lenacapavir for PrEP. I'm excited to have our field teams across market access, commercial, medical, community, and our nurse educators, mobilized, to ensure we're ready for launch.

在我們即將在美國推出用於 PrEP 的 lenacapavir 之前，人們對愛滋病毒預防的認識和採用不斷提高，這是令人鼓舞的。我很高興我們的市場准入、商業、醫療、社區和護理教育工作者等現場團隊都已動員起來，以確保我們已做好啟動的準備。

Building on our deep expertise and success of HIV launches and with strong engagement across the ecosystem from community leaders to healthcare providers, our teams are ready to build awareness; drive adoption; and, overall, deliver a seamless customer experience.

憑藉我們深厚的專業知識和在愛滋病毒防治工作中取得的成功，以及從社區領導到醫療保健提供者的整個生態系統的積極參與，我們的團隊已準備好提高人們的認識；推動採用；總體而言，提供無縫的客戶體驗。

Additionally, we're working with health authorities, policymakers, and other organizations outside of the US, as we look to bring lenacapavir for PrEP to more people, globally, once approved.

此外，我們正在與美國以外的衛生當局、政策制定者和其他組織合作，希望在獲得批准後，將用於 PrEP 的利那卡帕韋帶給全球更多人。

Moving to liver disease on slide 10. Sales of $758 million were up 3% year over year, reflecting increased demand across PBC, HBV, and HDV; partially offset by lower average realized price for HCV products in the US. Sequentially, liver disease sales were up 5%, primarily driven by increased demand and inventory dynamics, partially offset by lower average realized price.

前往第 10 張投影片討論肝病。銷售額為 7.58 億美元，年增 3%，反映了 PBC、HBV 和 HDV 需求的成長；但由於美國 HCV 產品的平均實際價格較低，部分抵消了這一影響。肝病銷售額環比增長 5%，主要受需求和庫存動態增長的推動，但平均實現價格的下降部分抵消了這一增長。

For Livdelzi, first-quarter sales of $40 million reflect continued early momentum in the launch of PBC. And we're proud of the market share we've achieved, so far.

對於 Livdelzi 來說，第一季 4000 萬美元的銷售額反映了 PBC 推出後的持續早期發展勢頭。我們對迄今為止所取得的市場份額感到自豪。

We're also pleased that in February, the European Commission granted conditional marketing authorization for Livdelzi. We've just launched in Germany a few weeks ago. And we expect to expand into other major European markets in the coming months.

我們也很高興，歐盟委員會在二月批准了 Livdelzi 的有條件上市許可。我們幾週前剛在德國推出產品。我們預計未來幾個月將擴展到其他主要歐洲市場。

Moving to slide 11. Veklury's sales of 302 million were down 45% year over year and 10% quarter over quarter, reflecting lower rates of COVID-19-related hospitalizations, due to a milder winter season.

移至投影片 11。Veklury 的銷售額為 3.02 億，年減 45%，季減 10%，這反映出由於冬季氣候較溫和，與 COVID-19 相關的住院率較低。

Veklury's consistently high share of over 60% of treated hospitalized patients in the US reinforces its clinical benefit and position as the standard of care, particularly among patients with renal and hepatic impairment. Despite the variability of the path of the pandemic, we expect Veklury's important role to continue.

Veklury 在美國住院治療患者中所佔比例一直很高，超過 60%，這鞏固了其臨床益處和作為治療標準的地位，特別是對於腎臟和肝臟功能不全的患者而言。儘管疫情的發展路徑存在變化，我們預計 Veklury 的重要角色仍將持續發揮。

On slide 12, Trodelvy's sales of $293 million were down 5% year over year, reflecting inventory dynamics and lower average realized price, partially offset by higher demand. Sequentially, sales were down 17%, primarily driven by inventory dynamics and lower demand.

在第 12 張投影片上，Trodelvy 的銷售額為 2.93 億美元，年減 5%，反映了庫存動態和較低的平均實現價格，但被更高的需求部分抵消。銷售額季減 17%，主要原因是庫存動態和需求下降。

Trodelvy remains the leading regimen in second-line metastatic triple negative breast cancer, in both the United States and Europe, with stable share in pre-treated HR-positive, HER2-negative metastatic breast cancer.

Trodelvy 仍然是美國和歐洲二線轉移性三陰性乳癌治療的領先方案，在已治療的 HR 陽性、HER2 陰性轉移性乳癌中佔有穩定的份額。

We also look forward to potentially bringing the benefits of Trodelvy to Triple Negative Breast Cancer patients in earlier lines of treatment, given the clinically meaningful progression-free survival benefits seen in ASCENT-04 and with data from ASCENT-03 expected later this quarter.

鑑於 ASCENT-04 中觀察到的具有臨床意義的無進展生存期益處以及預計本季度晚些時候發布的 ASCENT-03 數據，我們還期待將 Trodelvy 的益處帶給早期治療中的三陰性乳腺癌患者。

These studies could further strengthen our position in Triple Negative Breast Cancer, with almost double the addressable population compared to the second-line setting.

這些研究可以進一步加強我們在三陰性乳癌領域的地位，與二線治療相比，可針對的族群幾乎增加了一倍。

Moving to cell therapy on slide 13. Sales of $464 million were down 3% year over year and 5% sequentially, reflecting accelerating competitive headwinds. Notably, outside the US. And, more specifically, for Tecartus.

轉到第 13 張幻燈片討論細胞療法。銷售額為 4.64 億美元，年減 3%，季減 5%，反映出競爭壓力加劇。值得注意的是，在美國以外。更具體地說，對於 Tecartus 而言。

Yescarta's sales of $386 million were up 2% year over year, driven by higher average realized price and increased rest-of-world demand, partially offset by lower demand in the US. Sequentially, sales were down 1%, reflecting European-pricing favorability in the prior quarter that did not repeat, partially offset by higher demand outside the US.

Yescarta 的銷售額為 3.86 億美元，年增 2%，這得益於平均實現價格上漲和世界其他地區需求增加，但美國需求下降部分抵消了這一增長。環比銷售額下降 1%，反映出上一季歐洲定價優勢未再現，但美國以外地區需求增加部分抵銷了這一影響。

Tecartus' sales of $78 million were down 22% year over year and 20% sequentially, reflecting increased in- and out-of-class competition.

Tecartus 的銷售額為 7,800 萬美元，年減 22%，較上季下降 20%，反映出同類產品內外的競爭加劇。

Our work to increase CAR T-class penetration is ongoing and we continue to make progress in breaking down barriers to adoption in the community setting, including in accreditation and commercial reimbursement. More broadly, we continue to raise awareness of the strength of our data, the advantages of a one-time treatment, and the potential benefits of earlier CAR T.

我們致力於提高 CAR T 類藥物的普及率，並在打破社區採用障礙（包括認證和商業報銷）方面繼續取得進展。更廣泛地說，我們繼續提高人們對我們數據的優勢、一次性治療的優勢以及早期 CAR T 的潛在好處的認識。

Notwithstanding the ongoing competitive headwinds that we continue to expect to extend through 2025, we remain very excited about the overall opportunity and future for cell therapy, with the potential launch of anito-cel in multiple myeloma in 2026 and exciting early-stage data in our next-generation products across lymphoma and solid tumors at ASCO.

儘管我們預計持續的競爭阻力將持續到 2025 年，但我們仍然對細胞治療的整體機會和未來感到非常興奮，我們有可能在 2026 年推出用於治療多發性骨髓瘤的 anito-cel，並且在 ASCO 上展示我們用於治療淋巴瘤和實體瘤的下一代產品的令人興奮的早期數據。

Before I hand over to Dietmar, I'd like to thank the commercialization teams for delivering a great start to the year. We remain focused on expanding the reach of our current portfolio but are also very excited about the rich pipeline of near-term launches over the next 12 to 18 months.

在將工作交給迪特馬爾之前，我想感謝商業化團隊為今年帶來了一個好的開始。我們仍然專注於擴大現有產品組合的覆蓋範圍，但也對未來 12 至 18 個月內即將推出的豐富產品線感到非常興奮。

In addition to the ongoing launch of Livdelzi and the potential launch of lenacapavir for PrEP in 2025, we're also looking forward to the potential launch of anito-cel in multiple myeloma and Trodelvy in first-line metastatic triple negative breast cancer in 2026.

除了正在推出的 Livdelzi 和可能在 2025 年推出用於 PrEP 的 lenacapavir 之外，我們還期待在 2026 年推出用於治療多發性骨髓瘤的 anito-cel 和用於治療一線轉移性三陰性乳腺癌的 Trodelvy。

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

說完這些，我將把電話交給迪特馬爾。

Thank you, Johanna. Good afternoon, everyone.

謝謝你，約翰娜。大家下午好。

We have made a lot of progress in the first quarter, with some exciting lenacapavir updates at CROI and our first pivotal Phase 3 top-line readout for Trodelvy in breast cancer since 2022.

我們在第一季度取得了很大進展，在 CROI 上發布了一些令人興奮的 lenacapavir 更新，並且自 2022 年以來首次獲得了 Trodelvy 在乳腺癌治療中的關鍵 3 期頂線讀數。

The quality of these readouts highlights the breadth and depth of clinical expertise across Gilead, with the potential to support growth in our target therapeutic areas with new commercial launches in the years ahead.

這些讀數的品質凸顯了吉利德臨床專業知識的廣度和深度，並有可能在未來幾年透過新的商業發布來支持我們目標治療領域的成長。

Starting with HIV on slide 15. We shared 20 abstracts at CROI, including data that showcased lenacapavir's potential, even beyond the remarkable results we saw in PURPOSE 1 and PURPOSE 2 last year.

從第 15 張投影片上的 HIV 開始。我們在 CROI 上分享了 20 篇摘要，其中包括展示 lenacapavir 潛力的數據，甚至超越了我們去年在 PURPOSE 1 和 PURPOSE 2 中看到的顯著成果。

For example, we shared our Phase 1 data that showed once-yearly intramuscular injections maintained lenacapavir blood concentrations above those shown with twice-yearly subcutaneous injections for more than 12 months. The injections were generally well tolerated.

例如，我們分享了第一階段的數據，該數據顯示，每年一次的肌肉注射可維持利那帕韋的血液濃度高於每年兩次的皮下注射，持續時間超過 12 個月。注射通常耐受性良好。

These data were published in the Lancet and we look forward to initiating a Phase 3 study for once-yearly lenacapavir for HIV prevention in the second half of this year.

這些數據發表在《刺胳針》雜誌上，我們期待在今年下半年啟動每年一次的利那帕韋用於預防愛滋病毒的第三階段研究。

As a reminder: for our twice-yearly subcutaneous injection of lenacapavir for HIV prevention, we have already submitted NDA, MAA, and EU medicines for all applications with FDA and EMA. Further, we've submitted filings with regulatory bodies in South Africa and Brazil and continue to make good progress in all our discussions with the global regulatory bodies.

提醒一下：對於我們每年兩次皮下注射用於預防愛滋病毒的利那帕韋，我們已經向 FDA 和 EMA 提交了所有申請的 NDA、MAA 和 EU 藥品。此外，我們已向南非和巴西的監管機構提交了文件，並在與全球監管機構的所有討論中繼續取得良好進展。

In particular, we have not experienced any disruptions in our interactions with FDA. And we continue to expect a regulatory decision by June 19.

特別是，我們與 FDA 的互動沒有遇到任何中斷。我們仍然期待 6 月 19 日之前做出監管決定。

In HIV treatment, we shared Phase 2 data at CROI, evaluating twice-yearly lenacapavir plus two broadly neutralizing antibodies of bNabs in virologically-suppressed people with HIV genotypes that are highly susceptible to both bNabs.

在 HIV 治療中，我們在 CROI 分享了第 2 階段數據，評估了每年兩次使用利那帕韋加兩種廣譜中和 bNabs 抗體治療對 HIV 基因型病毒學抑制且對兩種 bNabs 高度敏感的人群的效果。

At week 26, the combination regimen maintained biologic suppression with high efficacy, similar to the stable baseline regimen comparator. There were no infusion-related reactions to the bNabs and no discontinuations due to injection-site reactions.

在第 26 週，聯合方案維持了較高的生物抑制療效，與穩定的基線方案比較器相似。沒有出現與 bNabs 輸液相關的反應，也沒有因注射部位反應而停藥。

Lenacapavir plus bNabs has already received breakthrough therapy designation from FDA. And these Phase 2 data further underscore the potential for this combination to be the first complete twice-yearly treatment regimen for virologically-suppressed people with HIV. Phase 3 planning is in progress.

Lenacapavir 加 bNabs 已經獲得 FDA 的突破性治療認證。這些第 2 階段數據進一步強調了這種組合療法有可能成為第一個針對病毒抑制 HIV 患者的完整的每年兩次的治療方案。第三階段規劃正在進行中。

Touching upon liver disease on slide 16, we announced the European Commission granted Conditional Marketing Authorization for Livdelzi for the treatment of primary biliary cholangitis or PBC.

在第 16 張幻燈片中談到肝病時，我們宣布歐盟委員會授予 Livdelzi 用於治療原發性膽汁性膽管炎或 PBC 的有條件上市許可。

The decision reflects Livdelzi's clinical benefit across key biomarkers of PBC and related providers in the Phase 3 RESPONSE trial. In addition, we continue to make progress on our Phase 3 IDEAL trial, which is evaluating the efficacy of Livdelzi in PBC patients, who are partial responders to UDCA, potentially doubling the addressable patient population.

該決定反映了 Livdelzi 在 3 期 RESPONSE 試驗中對 PBC 及相關提供者的關鍵生物標記的臨床益處。此外，我們在第 3 階段 IDEAL 試驗中繼續取得進展，該試驗正在評估 Livdelzi 對對 UDCA 有部分反應的 PBC 患者的療效，有可能使可尋址患者數量翻倍。

Overall, we are excited by the opportunities to bring this differentiated treatment to more patients across the world.

總的來說，我們很高興有機會為世界各地的更多患者提供這種差異化治療。

Moving to oncology on slide 17. I'm very pleased to share Trodelvy plus pembro demonstrated highly statistically significant and clinically meaningful progression-free survival benefit over standard of care in the Phase 3 ASCENT-04 trial in first-line PD-L1+ metastatic triple negative breast cancer.

轉到幻燈片 17 上的腫瘤學。我很高興地告訴大家，Trodelvy 加 pembro 在針對一線 PD-L1+ 轉移性三陰性乳癌的 3 期 ASCENT-04 試驗中表現出了比標準治療具有高度統計學意義和臨床意義的無進展生存期益處。

triple negative breast cancer is the most aggressive type of breast cancer that disproportionately impacts younger and pre-menopausal women. We look forward to being able to potentially bring the benefits of Trodelvy to these metastatic triple negative breast cancer patients in the first-line.

三陰性乳癌是最具侵襲性的乳癌類型，對年輕女性和停經前女性的影響尤其嚴重。我們期待能夠將 Trodelvy 的益處帶給這些第一線轉移性三陰性乳癌患者。

We will be submitting these data for presentation at a future medical congress and will engage with global regulators as quickly as possible. Further, we expect to provide an update from the Phase 3 ASCENT-03 trial, evaluating Trodelvy monotherapy in first-line metastatic triple negative breast cancer patients who are not candidates for PD-1 inhibitors, later this quarter.

我們將提交這些數據以便在未來的醫學大會上展示，並將盡快與全球監管機構接洽。此外，我們預計將在本季度稍後提供 3 期 ASCENT-03 試驗的最新消息，該試驗評估了 Trodelvy 單一療法對不適合使用 PD-1 抑製劑的一線轉移性三陰性乳癌患者的效果。

We also remain focused on clinical execution of our seven other ongoing Phase 3 programs for Trodelvy and domvanalimab across six tumor types.

我們也將繼續專注於針對六種腫瘤類型的 Trodelvy 和 domvanalimab 的其他七個正在進行的 3 期項目的臨床執行。

Moving to slide 18 and on behalf of Cindy and the Kite team, we are pleased to be sharing new data from our next-generation products at the upcoming ASCO meeting in June, including Phase 1 data from KITE-363; our bicistronic CD19/CD20 CAR T for relapsed or refractory large B-cell lymphoma; and Phase 1 data from the bicistronic EGFR IL13Ra2 CAR T for glioblastoma, in collaboration with the University of Pennsylvania - Perelman School of Medicine.

轉到第 18 張投影片，我代表 Cindy 和 Kite 團隊，很高興在即將於 6 月舉行的 ASCO 會議上分享我們下一代產品的新數據，包括 KITE-363 的第 1 階段數據；我們的雙順反子 CD19/CD20 CAR T 用於治療復發或難治性大宮母細胞淋巴瘤以及賓州大雷醫學醫學院的雙膠質曼醫學院治療復發性大雷氏大學 BGFR； IL13Ra2 CAR T 的 1 期數據。

We believe KITE-363 could offer deeper, more sustained responses, with the potential to overcome certain resistance mechanisms, given its ability to target both CD19 and CD20. Additionally, we believe it's dual co-stimulatory domains balance effects, such as rapid tumor cell-killing and CAR T-cell proliferation and persistence in an optimal way. This could result in a potentially improved overall efficacy and safety profile in B-cell malignancies.

我們相信，鑑於 KITE-363 能夠同時靶向 CD19 和 CD20，它可以提供更深層、更持久的反應，並有可能克服某些抗性機制。此外，我們相信它的雙重共刺激域能夠以最佳方式平衡效應，例如快速殺死腫瘤細胞和 CAR T 細胞增殖和持久性。這可能會提高 B 細胞惡性腫瘤的整體療效和安全性。

Further, we believe many of these potential benefits could translate to B cell-driven autoimmune diseases and have filed an IND to evaluate KITE-363 in this area, as well.

此外，我們相信其中許多潛在益處可以轉化為 B 細胞驅動的自體免疫疾病，並且已經提交了 IND 來評估 KITE-363 在該領域的應用。

For anito-cel, our pivotal iMMagine-1 study in fourth-line-plus relapsed or refractory multiple myeloma is ongoing. And we look forward to providing an update in 2025.

對於 anito-cel，我們針對四線以上復發或難治性多發性骨髓瘤的關鍵 iMMagine-1 研究正在進行中。我們期待在 2025 年提供更新。

In the second-line-plus setting, we are pleased to announce the Phase 3 iMMagine-3 protocol has been amended to include minimal residual disease negativity as a dual primary endpoint, in addition to progression-free survival.

在二線加治療中，我們很高興地宣布，第 3 階段 iMMagine-3 方案已被修改，除了無惡化存活期外，還將微小殘留疾病陰性作為雙重主要終點。

We're excited for this positive step to potentially bring anito-cel to patients in early-line settings and remain confident in anito-cel's profile across efficacy and safety, combined with Kite's leading manufacturing capabilities.

我們很高興看到這一積極的進展，有可能將 anito-cel 帶給早期患者，並且我們對 anito-cel 在療效和安全性方面的表現以及 Kite 領先的製造能力充滿信心。

Finally, on slide 19, we achieved several important milestones this year, including European Commission Conditional approval of Lyvdelzi; positive Phase 3 top-line readout from ASCENT-04; and initiation of the Phase 3 EVOKE Small Cell Lung Cancer study. We anticipate an update from the Phase 3 ASCENT-03 trial, later this quarter.

最後，在第 19 張投影片上，我們今年取得了幾個重要的里程碑，包括歐盟委員會有條件批准 Lyvdelzi；ASCENT-04 第三階段頂線讀數呈陽性；並啟動第三階段 EVOKE 小細胞肺癌研究。我們預計本季稍後將公佈第三階段 ASCENT-03 試驗的最新消息。

Additionally, in virology, we remain on track to provide an update on the data from our Phase 2 WONDERS-1 trial, our wholly owned once-weekly INSTI-containing oral treatment for HIV at an upcoming medical meeting.

此外，在病毒學方面，我們將繼續在即將召開的醫學會議上提供第 2 階段 WONDERS-1 試驗數據的最新信息，這是我們全資擁有的每週一次的含有 INSTI 的 HIV 口服治療藥物。

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

現在，我將把電話交給安迪。

Thank you, Dietmar. Good afternoon, everyone.

謝謝你，迪特馬爾。大家下午好。

Our first-quarter results reflect both strong operating and commercial execution.

我們第一季的業績反映了強勁的營運和商業執行。

As shown on slide 21, our base business was up 4% year over year to $6.3 billion, largely driven by growth in our HIV and liver disease business, partially offset by lower oncology sales.

如第 21 張投影片所示，我們的基礎業務年增 4%，達到 63 億美元，這主要得益於愛滋病毒和肝病業務的成長，但腫瘤學銷售額的下降部分抵消了這一增長。

Veklury's sales were down 45% year over year, resulting in a 1% decline in our total product sales to $6.6 billion.

Veklury 的銷售額年減 45%，導致我們的總產品銷售額下降 1% 至 66 億美元。

Moving to our non-GAAP results on slide 22. For the first quarter, product gross margin was flat year over year at 85%, in line with our full-year guidance expectation of 85% to 86%.

轉到幻燈片 22 上的非 GAAP 結果。第一季度，產品毛利率與去年同期持平，為 85%，符合我們對全年 85% 至 86% 的預期。

R&D expenses were down 5% year over year, primarily due to lower clinical manufacturing activities. Acquired IPR&D expenses were $253 million, primarily driven by the LEO Pharma STAT6 collaboration we announced in January. SG&A expenses were down 6% year over year, reflecting lower corporate expenses, partially offset by incremental selling and marketing spend in the United States.

研發費用較去年同期下降 5%，主要原因是臨床製造活動減少。收購的智慧財產權與開發費用為 2.53 億美元，主要得益於我們在一月宣布的 LEO Pharma STAT6 合作。銷售、一般及行政費用較去年同期下降 6%，反映出企業費用下降，但美國銷售和行銷支出的增加部分抵銷了這一下降。

First-quarter operating margin was 43%, highlighting our ongoing commitment to continue the operating expense discipline and delivering top-quartile margins, once again.

第一季的營業利潤率為 43%，凸顯了我們持續致力於嚴格控制營業費用並再次實現最高四分位的利潤率。

The non-GAAP effective tax rate was 16% this quarter, below our historic average, largely driven by tax benefits from stock-based compensation. And finally, non-GAAP diluted EPS was $1.81.

本季非公認會計準則有效稅率為 16%，低於我們的歷史平均水平，這主要得益於股票薪資的稅收優惠。最後，非 GAAP 稀釋每股收益為 1.81 美元。

Moving to our full-year guidance on slide 23, we are not making any changes to our revenue expectations or non-GAAP P&L guidance at this time.

轉到幻燈片 23 上的全年指導，我們目前不會對我們的收入預期或非 GAAP 損益指導做出任何更改。

As we reflect on the tariffs that have been enacted, to date, these could increase some of our indirect costs but are expected to be manageable in 2025, in part due to potentially lighter FX headwinds than previously expected.

當我們回顧迄今為止已經實施的關稅時，這些關稅可能會增加我們的一些間接成本，但預計到 2025 年將是可控的，部分原因是外匯逆風可能比之前預期的要小。

For 2025, therefore, we continue to expect total product sales of approximately $28.2 billion to $28.6 billion; product sales, excluding Veklury, of approximately $26.8 billion to $27.2 billion; 2025 HIV sales to be approximately flat compared to 2024, with demand-driven growth offset by the impact of the Medicare Part D redesign; and Veklury's sales of approximately $1.4 billion.

因此，我們繼續預期 2025 年產品總銷售額約為 282 億美元至 286 億美元；不包括 Veklury 的產品銷售額約為 268 億美元至 272 億美元； 2025 年 HIV 銷售額與 2024 年相比基本持平，需求驅動的增長將被醫療保險 D 部分重新設計的影響力約為 Veklury 的 14 億美元銷售額；

While the first quarter was lighter than expected, we know this can be a highly variable business. With that in mind and consistent with our approach last year, we do not expect to update our Veklury guidance until our third-quarter earnings call.

雖然第一季的業績比預期要淡，但我們知道這是一個高度可變的業務。考慮到這一點，並且與我們去年的做法一致，我們預計在第三季財報電話會議之前不會更新我們的 Veklury 指導。

Moving to other parts of the P&L for full-year 2025, on a non-GAAP basis.

按照非 GAAP 基礎，轉向 2025 年全年損益表的其他部分。

We continue to expect product gross margin to range between 85% to 86%. R&D expenses to be roughly flat from 2024. Acquired IPR&D to be approximately $400 million, including the $253 million of expenses in the first quarter, as well as known commitments and expected milestone payments. SG&A expenses to decline by a high-single-digit percentage compared to 2024.

我們繼續預期產品毛利率將在 85% 至 86% 之間。自2024年起，研發費用將基本持平。收購IPR&D約為4億美元，其中包括第一季的2.53億美元支出，以及已知承諾和預期的里程碑付款。與 2024 年相比，銷售、一般及行政費用 (SG&A) 將下降高個位數百分比。

Operating income to be between $12.7 billion to $13.2 billion. Effective tax rate to be approximately 19%. And, finally, diluted EPS to be between $7.70 to $8.10 for the full year.

營業收入在127億美元至132億美元之間。有效稅率約為19%。最後，全年稀釋每股收益將在 7.70 美元至 8.10 美元之間。

Looking ahead, we will continue to monitor the macro landscape, carefully. And we expect that our disciplined approach to operating expense management positions us well to adapt as needed in the months ahead.

展望未來，我們將繼續密切關注宏觀情勢。我們期望，我們嚴謹的營運費用管理方法能夠讓我們在未來幾個月內根據需求進行調整。

Finally, on slide 24, our capital priorities remain unchanged. We have already returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases and we will continue to pursue disciplined expense management and careful investment in the most promising pipeline opportunities, both internally and externally.

最後，在第 24 張投影片上，我們的資本優先事項保持不變。我們已經在 2025 年第一季透過股利和股票回購向股東返還了 17 億美元，我們將繼續推行嚴格的費用管理，並對內部和外部最有前景的通路機會進行謹慎投資。

I'm also pleased to note that S&P recently upgraded Gilead's long-term debt rating from BBB+ with a positive outlook to A- with a stable outlook, recognizing the outlook for our HIV franchise and other products, combined with steady revenue growth and strong cash flow generation.

我還很高興地註意到，標準普爾最近將吉利德的長期債務評級從 BBB+（展望積極）上調至 A-（展望穩定），認可我們的 HIV 特許經營權和其他產品的前景，以及穩定的收入增長和強勁的現金流產生。

Overall, Gilead is on track to continue delivering demand-led volume growth, a disciplined operating model, and strong cash flow that positions us well for the rest of 2025 and beyond.

總體而言，吉利德有望繼續實現需求主導的銷售成長、嚴謹的營運模式和強勁的現金流，這將為我們在 2025 年剩餘時間及以後做好充分準備。

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

現在，我將邀請 Rebekah 開始問答環節。

Thank you, Andy.

謝謝你，安迪。

(Operator Instructions)

（操作員指示）

Michael Yee, Jefferies.

麥可‧餘 (Michael Yee)，傑富瑞集團 (Jefferies)。

Hey. Great. Thanks. Congrats on the quarter and progress.

嘿。偉大的。謝謝。恭喜本季取得的進展。

We wanted to ask about your expectations for the PrEP launch; and assuming approval on time, how you think about the dynamics in the second half, related to commercial reimbursement and Medicaid reimbursement; and whether guideline changes and other factors also need to play a role.

我們想詢問您對 PrEP 發布的期望；並假設按時獲得批准，您如何看待下半年與商業報銷和醫療補助報銷相關的動態？以及指導方針的變化和其他因素是否也需要發揮作用。

Thanks.

謝謝。

Hi, Michael. It's Johanna. Thanks for the question.

你好，麥可。是喬安娜。謝謝你的提問。

Yeah. So we're excited about the opportunity, with the PDUFA date around the corner. We are counting -- I think Dan referred to weeks, the team is counting days. And we are absolutely ready for the launch.

是的。因此，隨著 PDUFA 日期臨近，我們對這個機會感到非常興奮。我們正在數數——我想丹指的是幾週，而團隊正在數天。我們已經做好了充分的準備來發布該產品。

From an access standpoint, what we've said is we believe that around -- it was going to take a couple of months, right as it builds access. We think about 75% or so access within the first 6 months to a peak covered lives at about 90% at a 12-month mark.

從訪問的角度來看，我們說過，我們相信這將需要幾個月的時間，正好用於建立訪問。我們認為，前 6 個月的覆蓋率約為 75%，而 12 個月的覆蓋率將達到峰值，約為 90%。

And that's going to happen month after month. And it doesn't all happen in a (inaudible).

而這種情況將會逐月發生。這一切並非總是發生在（聽不清楚）。

We also believe, at the beginning, that they're going to go through medical exceptions, right? And they'll go through the process just like they do, for example, with Livdelzi, as we're building access there as well.

我們一開始也相信他們會經歷醫療例外，對嗎？他們會經歷這個過程，就像他們在 Livdelzi 所做的那樣，因為我們也在那裡建立訪問權限。

And we believe that just takes a little bit more time but, still, could get through the process for those people that want lenacapavir.

我們相信，這只需要多花一點時間，但對於那些想要獲得利那帕韋的人來說，仍然可以完成這個過程。

And so, we'll work through that. And we're excited about that opportunity, as we build out through 2025 and, of course, into 2026 with much stronger access.

所以，我們會努力解決這個問題。我們對這個機會感到非常興奮，因為我們將在 2025 年甚至 2026 年實現更強大的訪問能力。

Carter Gould, Cantor Fitzgerald.

卡特古爾德、康托費茲傑拉。

Great. Thank you. Good afternoon.

偉大的。謝謝。午安.

Following on the prior question: there've been a number of cuts across HHS, CDC to start the year, across various teams, divisions, raising uncertainty around potential disruptions to messaging, education, awareness, can you help, maybe, frame some of these and, specifically, as they might impact the launch?

接著上一個問題：今年年初，美國衛生與公眾服務部 (HHS) 和疾病預防控制中心 (CDC) 的各個團隊和部門都進行了多項削減，這引發了人們對信息傳遞、教育和意識可能中斷的不確定性，您能否幫助闡述其中的一些問題，特別是它們可能對發布產生的影響？

And are these -- either roles or activities that Gilead could, maybe, step into to do some of the heavy lifting? And, really, your confidence that we won't be pointing to these aspects of impacting the launch later in '25 or into '26?

那麼，吉利德是否可以介入這些角色或活動來承擔一些繁重的工作呢？您真的有信心我們不會指出這些方面對 2025 年或 2026 年的發布會產生影響嗎？

Thank you.

謝謝。

Thanks, Carter. This is Dan. I'll start. And then, Johanna can add -- or others.

謝謝，卡特。這是丹。我先開始。然後，喬安娜可以添加——或其他內容。

But I just want to be clear that, to date, we haven't heard or seen anything that would cause us to alter our plans or expectations for the LEN for PrEP launch or adversely affect our HIV business.

但我只想明確一點，到目前為止，我們還沒有聽到或看到任何會導致我們改變 LEN for PrEP 推出計劃或期望或對我們的 HIV 業務產生不利影響的事情。

Obviously, we're staying very closely attuned to this. And, importantly, we're having discussions with policymakers to emphasize the importance of lenacapavir from PrEP and, in, particular, in relation to their stated goals of addressing chronic diseases in this country and the value of prevention. We think that LEN for PrEP is really well positioned, there.

顯然，我們對此保持密切關注。而且，重要的是，我們正在與政策制定者進行討論，強調 PrEP 中利那帕韋的重要性，特別是與他們所述的解決該國慢性病的目標和預防的價值有關。我們認為 LEN 的 PrEP 定位確實非常出色。

Specifically, relative to the government support and, in particular you mentioned CDC, Carter, obviously, their responsibilities include research and surveillance of HIV. They include supporting efforts around diagnosis and linkage to care.

具體來說，相對於政府支持，特別是您提到的疾病預防控制中心，卡特，顯然他們的職責包括愛滋病毒的研究和監測。其中包括圍繞診斷和護理聯繫的支持工作。

We're also involved in those activities. But, again, nothing we've seen, so far, suggests that those core services are in a position to change our approach to the launch.

我們也參與了這些活動。但是，到目前為止，我們還沒有看到任何跡象表明這些核心服務能夠改變我們的發布方式。

And, maybe, with that, I'll hand it over to Johanna if she has any other questions; or Dietmar, if you want to comment on the FDA too.

也許，如果 Johanna 還有其他問題的話，我會把這個問題交給她；或者 Dietmar，如果你也想對 FDA 發表評論的話。

Sure. Yeah. Maybe, just to add a point card around PrEP market growth and what you ask -- what Gilead can do?

當然。是的。也許，只是為了增加一張關於 PrEP 市場成長的積分卡，以及你所問的——吉利德能做什麼？

I think that Gilead's been incredibly focused on making sure we continue to have market development initiatives to ensure screening, diagnosis, for treatment; but, also, to ensure awareness and within the PrEP market and make sure there's education there, as well.

我認為吉利德一直非常注重確保我們繼續擁有市場開發計劃，以確保篩檢、診斷和治療；但同時，也要確保人們的認識，在 PrEP 市場內，也要確保那裡也有教育。

And I think you've seen that. As you think about the PrEP market growth, we had a lot of activities in Q4 of last year. And that's playing out. We saw a nice uplift of the growth of the PrEP market in Q4 and you see that come through, again, in Q1 at about 16% year over year.

我想你已經看到了。當您考慮 PrEP 市場成長時，我們在去年第四季開展了許多活動。事情正在發生。我們看到 PrEP 市場在第四季度出現了良好的成長，你會看到，第一季的成長率與去年同期相比再次達到了 16% 左右。

So really well positioned, as you think about lenacapavir around the corner.

因此，當您想到即將出現的 lenacapavir 時，我們的定位確實非常有利。

And on the FDA side. At this time, all our interactions with the FDA have been on track; have been as expected, without any surprises so we've not experienced any impact on our LEN for PrEP filing or any of our clinical trials actually, to date.

以及 FDA 方面。目前，我們與 FDA 的所有互動均已步入正軌；一切如預期，沒有任何意外，因此到目前為止，我們的 PrEP 申請 LEN 或任何臨床試驗實際上都沒有受到任何影響。

And we continue to expect the lenacapavir and decision by June 19.

我們將繼續期待 6 月 19 日之前對 lenacapavir 做出決定。

James Shin, Deutsche Bank.

德意志銀行的詹姆斯辛 (James Shin)。

Thank you.

謝謝。

I have a question for Johanna. Johanna, the strength in Descovy for this quarter, is there any read-through or implications on -- it looks like there was some price benefits to the Descovy but is there any read-through or implications to LEN's launch?

我有一個問題想問喬安娜。喬安娜，本季 Descovy 的優勢是什麼，有什麼解讀或影響嗎？看起來 Descovy 有一些價格優勢，但對 LEN 的推出有什麼解讀或影響嗎？

Yeah. There is. Thanks for the question.

是的。有。謝謝你的提問。

Yeah. We saw a really nice growth year on year, about 38% growth for Descovy. That was driven by higher average realized price, as you mentioned, as well as higher demand. Those are the two big drivers.

是的。我們看到了同比成長的非常好，Descovy 的成長率為 38%。正如您所說，這是由更高的平均實現價格以及更高的需求所推動的。這是兩個主要驅動因素。

And there's a couple of reasons behind that. One is definitely the PrEP market growth that I was referring to earlier, around 16% year on year, driven, really, by the market development that we've done, that we've been leading.

這背後有幾個原因。一是，我之前提到的 PrEP 市場肯定有所成長，年增約 16%，這其實得益於我們所做的、我們所引領的市場開發。

And second was around focused commercial execution. We've actually grown the share of Descovy year on year by about -- just over 3 percentage points, which is really amazing. And that's driven by the commercial team, which have been doing an amazing job; but, also, supported by growing unrestricted access that we've seen, even just in the last quarter, to be honest; as well as associated lower copays, which also helps our pricing.

第二是圍繞重點商業執行。實際上，我們 Descovy 的份額比去年同期增長了約 3 個百分點，這真是太神奇了。這是由商業團隊推動的，他們一直做得非常出色；但同時，我們也看到，即使只是在上個季度，不受限制的訪問也得到了支持；以及相關的較低共付額，這也有助於我們的定價。

So all of those pieces together get you to that 38% year on year. And I do believe, actually, because of that PrEP market growth; because of the set-up, from an access standpoint -- really supports the opportunity with lenacapavir, hopefully, in June.

因此，所有這些因素加在一起，就實現了同比增長 38%。事實上，我確實相信，由於 PrEP 市場的成長；因為從訪問的角度來看，這種設定確實支持了 lenacapavir 的機會，希望在 6 月。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good afternoon. Thanks for taking my question.

午安.感謝您回答我的問題。

You touched on this a little earlier. But while Gilead seems fairly -- or unexposed to tariff risk here, can you just share any details on how much of the US market is supplied by ex-US manufacturing, either API-finished product? And to what degree you can shift this to the US? And is it fair to say limited risk to the business, from a tax-transfer pricing perspective?

您剛才提到了這一點。但是，儘管吉利德似乎沒有受到關稅風險的影響，您能否分享一些細節，說明美國市場有多少是由美國以外的製造業（API 成品）供應的？你能在多大程度上將其轉移到美國？從稅務轉移定價的角度來看，是否可以說企業的風險有限？

And if I could also just get a clarification with regard to earnings, earlier, on the redesign; with regard to whether your assumptions are unchanged here? And whether you could just comment on how this is taking shape, relative to your 2025 guide, given the dynamics to date?

如果我之前能就重新設計的效益問題得到澄清，關於您的假設是否沒有改變？並且，考慮到迄今為止的動態，您能否評論一下相對於您的 2025 年指南而言，這一進展如何？

Thank you.

謝謝。

Great. Thanks, Salveen. Let me just start at the high level. And then, I'll hand it over to Andy or Johanna to comment a little more deeply.

偉大的。謝謝，薩爾文。讓我先從高層次開始。然後，我會將其交給安迪 (Andy) 或喬安娜 (Johanna) 進行更深入的評論。

Just to emphasize what you said around the tariffs: I think, at the highest level, of course, we separate them into two different categories. One is indirect tariffs, which are related to all businesses. And, for us, they are things like steel, lab supplies, chemicals, reagents.

只是想強調你關於關稅的說法：我認為，當然，在最高層面上，我們將它們分為兩個不同的類別。一是間接關稅，與所有企業都有關。對我們來說，它們是鋼鐵、實驗室用品、化學品、試劑之類的東西。

And, obviously, there, we have some known understanding of what those tariffs will be. And what we see, so far, today, we've absorbed into our guidance, without changing our guidance for the rest of the year. And Andy can comment a little further on that.

顯然，我們對這些關稅有一些了解。到目前為止，我們已經將今天看到的情況納入了我們的指導中，並且不會改變今年剩餘時間的指導。安迪可以對此做進一步的評論。

And then, the other category of tariffs are, obviously, the pharmaceutical-specific tariffs, which are not enacted today. They've only been discussed and chatted about. We obviously haven't speculated on those nor included those.

然後，另一類關稅顯然是針對藥品的關稅，目前尚未頒布。人們只是討論和談論它們。我們顯然沒有對這些進行推測，也沒有將這些包括在內。

But, to your point, I think that there is a difference, relative to Gilead's make-up and set-up that is important when you consider those tariffs. And that is that the vast majority of Gilead's IP is in the US.

但是，就您的觀點而言，我認為，相對於吉利德的組成和設置而言，存在一個差異，當您考慮這些關稅時，這一點很重要。那就是吉利德的絕大部分智慧財產權都在美國。

And what that suggests is lower value for its pharmaceutical imports, at the end of the day, which is the value on which tariffs would be placed. In fact, more than 80% of Gilead's profits are recognized in the US.

這意味著其進口藥品的價值最終會降低，而徵收關稅的價值正是基於這個價值。事實上，吉利德80%以上的利潤都是在美國實現的。

To your question around the supply chain: it's quite a complicated answer. We do have -- the strongest footprint we have is in the United States.

對於您關於供應鏈的問題：答案相當複雜。我們確實有——我們最強大的影響力是在美國。

Like most companies, we leverage both internal and external manufacturing on a global basis. And we're always looking to adapt that to make sure that we have good continuity of supply across the world so that we can do that, accordingly.

與大多數公司一樣，我們在全球範圍內利用內部和外部製造。我們一直在尋求適應這一點，以確保我們在全球範圍內擁有良好的供應連續性，以便我們能夠做到這一點。

I'd also say that we've invested significantly in our manufacturing infrastructure in the United States, over the past many years; and our R&D infrastructure, including opening cell therapy manufacturing sites. And we have four large-scale US investment projects in progress that are expected to run through 2028.

我還要說的是，過去多年來，我們對美國製造業基礎設施進行了大量投資；以及我們的研發基礎設施，包括開放細胞療法製造基地。我們還有四個大型美國投資項目正在進行中，預計將持續到2028年。

So it's difficult to get into the detail of every product in every supply chain. But I think we're well positioned, overall.

因此，很難了解每個供應鏈中每種產品的詳細資訊。但我認為，總體而言，我們處於有利地位。

I would ask Andy to comment and, maybe, Johanna on the Medicare part. (inaudible)

我想請安迪 (Andy) 就醫療保險部分發表評論，也許，也請喬安娜 (Johanna) 對此發表評論。（聽不清楚）

Hi, Salveen. It's Andy.

你好，Salveen。是安迪。

Just to confirm what Dan said: our updated guidance does reflect the expected impact of the increase in indirect costs that we've seen from both announced tariffs and reciprocal tariffs, as well as our general expectations for the inflationary environment that we may be moving into.

只是為了證實丹所說的話：我們更新後的指引確實反映了我們從宣布的關稅和互惠關稅中看到的間接成本增加的預期影響，以及我們對可能進入的通膨環境的總體預期。

And, as you can expect, there are a number of puts-and-takes in the P&L. But, as you look, again, at another very strong quarter of disciplined expense management, that helps us absorb some of those additional costs.

而且，正如您所預料的，損益表中存在許多買賣。但是，正如您所看到的，我們又經歷了一個非常強勁的季度，嚴格的費用管理幫助我們吸收了部分額外成本。

There's also a bit of a tailwind, as you've heard from our peers, in terms of how the US dollar is weakened for those of us that are based in the United States. There's a tailwind, relative to our budgeted FX amounts that will help offset some of those, as well.

正如您從我們的同行那裡聽到的，對於我們這些在美國的人來說，美元走弱也帶來了一點順風。相對於我們預算的外匯金額，順風也有助於抵消其中的一些影響。

So we're very confident, today, that with the strong growth you saw in the base business in the first quarter; despite the Part D impact, which Joanna can speak to; even with the tariffs, we're happy to reconfirm our guidance for the year. And we feel like we're in a good spot.

因此，今天我們非常有信心，隨著第一季基礎業務的強勁增長；儘管有 D 部分的影響，但喬安娜可以談論這一點；即使有關稅，我們也很高興再次確認今年的業績預期。我們感覺處境很好。

And, maybe, just specific to your Part D redesign question: although still quite early in the stages of implementation, just important to note that Medicare claims will lag by a quarter. So we're still looking for that data. And we'll get that sometime late Q2, for the first quarter of this year.

也許，只是針對您的 D 部分重新設計問題：儘管實施階段仍處於相當早期的階段，但需要注意的是，醫療保險索賠將滯後四分之一。所以我們仍在尋找該數據。我們將在今年第二季末，也就是今年第一季實現這一目標。

Our assumptions haven't changed. We continue to expect about that $1.1 billion-dollar that we shared for total impact; of which, about $900 million or so is specific to HIV.

我們的假設沒有改變。我們繼續預期我們分享的 11 億美元將產生整體影響；其中約9億美元專門用於治療愛滋病毒。

And in terms of phasing, we do expect some linear progression over the quarters. That's, in part, driven by the cost of our medicines.

就分階段而言，我們確實預期各季度會出現一些線性進展。這在某種程度上是由我們的藥品成本所造成的。

And then, last but not least, we're really quite pleased with our Q1 results. If you think about our HIV business growing 6 points year over year, if you were to take out Part D redesign, you'd be looking at a 9% growth year over year.

最後但同樣重要的一點是，我們對第一季的業績非常滿意。如果您認為我們的 HIV 業務同比增長 6 個百分點，那麼如果您進行 D 部分重新設計，您將看到同比增長 9%。

So we're really pleased with how HIV is playing out; and being able to navigate those seasonal dynamics of inventory that we always see in Q1; but, also, the Part D redesign dynamics.

所以我們對愛滋病毒的進展感到非常高興；並能夠應對我們在第一季經常看到的庫存季節性動態；而且，還有 D 部分重新設計的動力。

(Operator Instructions)

（操作員指示）

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Hey, guys. Thanks very much.

嘿，大家好。非常感謝。

For Trodelvy, is the lower demand quarter over quarter due to bladder coming out or lower demand in breast? It'd be helpful if you could elaborate on that.

對 Trodelvy 來說，季度環比需求下降是因為膀胱切除還是乳房需求下降？如果您能詳細說明這一點，將會很有幫助。

Sure. It's Johanna. I'll take that one.

當然。是喬安娜。我要那個。

Yeah. So quarter over quarter has to do with inventory and a little bit of lower demand, just because Q4 was really strong -- performance. But if you look at our year on year, at about minus 5%, that's really just inventory dynamic and lower average realize price, due to channel mix and higher demand.

是的。因此，季度環比成長與庫存和需求略有下降有關，只是因為第四季度的表現確實強勁。但如果你看一下我們的同比數據，大約為負5％，這實際上只是庫存動態和較低的平均實現價格，這是由於渠道組合和需求增加造成的。

So we are trending, nicely, with Trodelvy and holding a really nice position, both in second-line metastatic Triple Negative Breast Cancer; and as well as HR-positive, HER2-negative.

因此，我們與 Trodelvy 的合作發展勢頭良好，在二線轉移性三陰性乳癌治療中佔有非常好的地位；以及 HR 陽性、HER2 陰性。

So we feel confident with what's to come in 2025. Let alone with the great positive news on ASCENT-04 that just reinforces the confidence for physicians in the second-line setting, with the data that we had originally showed with ASCENT.

因此，我們對 2025 年的未來充滿信心。更不用說 ASCENT-04 的重大利好消息，它透過我們最初在 ASCENT 上展示的數據增強了醫生在二線治療中的信心。

Daina M. Graybosch, Leerink Partners.

Daina M. Graybosch，Leerink Partners。

Hi. Thanks for the question.

你好。謝謝你的提問。

I wonder if we can talk about the process to add lenacapavir to the USPSTF mandate for coverage about cost sharing, assuming SCOTUS upholds the constitutionality in June.

我想知道，假設最高法院在六月維持其合憲性，我們是否可以討論將 lenacapavir 添加到 USPSTF 費用分攤覆蓋範圍的流程。

So what's the timing of that being added? And how much impact or uplift do you expect in revenue and growth in the US, when it's added to the mandate?

那麼添加該功能的時間是什麼時候？當它被添加到授權中時，您預計會對美國的收入和成長產生多大的影響或提升？

Thank you.

謝謝。

Thanks, Daina, for your question. Johanna, again.

謝謝戴娜 (Daina) 提出的問題。又是喬安娜。

I think what's important is that we are assuming that it's going to take a little bit of time for USPSTF to add lenacapavir as the process -- obviously, from a guideline standpoint, we've already seen those guidelines play out. When you think about IAS guidelines, we already have lenacapavir there, prior to even approval.

我認為重要的是，我們假設 USPSTF 將需要一點時間來添加 lenacapavir——顯然，從指南的角度來看，我們已經看到這些指南發揮作用。當您考慮 IAS 指南時，您會發現，在獲得批准之前，我們已經擁有了 lenacapavir。

But, usually, they wait for approval. And then, we go forward with trying to get medical updates through -- including USPSTF.

但通常情況下，他們會等待批准。然後，我們繼續嘗試透過包括 USPSTF 在內的管道獲取醫療更新資訊。

We do believe, though, that despite this, we feel we're incredibly well positioned because of the transformative nature of lenacapavir to build access across the different channels that -- and we're prepared to do that.

然而，我們確實相信，儘管如此，我們仍然覺得我們處於非常有利的位置，因為利那帕韋具有變革性，可以透過不同的管道建立訪問管道——而且我們已經準備好這樣做了。

And that's, again, going to take a little bit of time, over the next 6 to 12 months. But we feel that that would be. In line with what we've seen in the past, with other agents, including Descovy. And we're going to be leveraging all the guidelines possible to make sure that there's a real value that's displayed for access to go as quickly as possible.

而這又需要一點時間，在接下來的 6 到 12 個月內。但我們覺得確實如此。與我們過去看到的情況一致，包括 Descovy 在內的其他代理商也採取了同樣的措施。我們將利用所有可能的指導方針，確保顯示的真正價值能夠盡快實現。

USPSTF would be nice to have, to be honest with you. But in the first 6 to 12 months, we're assuming that that's not going to be in play. And our plans are really based on our value proposition of lenacapavir.

說實話，如果有 USPSTF 就好了。但在前 6 到 12 個月內，我們假設這種情況不會發生。我們的計劃確實基於利那帕韋的價值主張。

Geoff Meacham, Citigroup.

花旗集團的傑夫‧米查姆。

Oh. Great. Afternoon, guys. Thanks so much for the question.

哦。偉大的。下午好，各位。非常感謝您的提問。

I have one for Dietmar. So on the HIV treatment opportunity and looking to your long-acting orals, the question is what's the gating factor for selecting the best Phase 3 combo?

我有一個給 Dietmar 的。因此，就愛滋病毒治療機會和長效口服藥物而言，問題是選擇最佳 3 期組合的限制因素是什麼？

And related to that, while you haven't seen resistance with LEN -- it hasn't really been an issue -- would it still make sense to have, in the treatment setting, a 3-drug versus a 2-drug combo, just to mitigate the lower risk of resistance?

與此相關，雖然您沒有看到 LEN 出現抗藥性（這實際上不是一個問題），但在治療環境中，採用 3 種藥物而不是 2 種藥物組合是否仍然有意義，只是為了降低抗藥性風險？

Thank you.

謝謝。

Thank you, Geoff, for the question.

謝謝傑夫提出的問題。

That's really early in our development program, here. I think the important piece is that we're looking for optionality. We're really looking for the breadth and depth of the portfolio to deliver for people, basically, with monthly and weekly; and, in the PrEP setting, obviously, once every 6 months and, potentially, also once-every-year options.

這是我們開發計劃的早期階段。我認為重要的是我們正在尋找可選性。我們真正尋求的是為人們提供具有廣度和深度的投資組合，基本上是按月和按週的方式；在 PrEP 設置中，顯然每 6 個月一次，也可能每年一次。

In the immediate future, obviously, we're really looking forward, as discussed, right, to the LEN for PrEP launch. But then, we also had data at CROI, right?

在不久的將來，顯然，正如討論的那樣，我們非常期待 LEN for PrEP 的推出。但是，我們在 CROI 也有數據，對嗎？

We were talking about the potential of lenacapavir for once-every-year PrEP. And that, of course, is some of our focus areas.

我們正在討論使用 lenacapavir 作為每年 PrEP 治療的潛力。當然，這也是我們的重點領域。

Obviously, we will look at the overall portfolio and see the options that we want to develop, which ones we can take forward.

顯然，我們將審視整體投資組合，看看我們想要開發的選項以及我們可以採取的選項。

Chris Schott, J.P. Morgan.

摩根大通的克里斯·肖特。

Great. Thanks so much.

偉大的。非常感謝。

Just was hoping to get a little bit more color on the Livdelzi launch, so far. Just elaborate a bit more on what you're seeing, from a competitive standpoint; and how that ramp is progressing, relative to your internal expectations.

到目前為止，我只是希望對 Livdelzi 的發布有更多的了解。從競爭的角度，稍微詳細地闡述你所看到的；以及相對於你的內部預期而言，這個成長坡度的進展如何。

Thank you.

謝謝。

Thanks, Chris. Johanna.

謝謝，克里斯。約翰娜。

Yeah. We're really pleased with the progression of Livdelzi, right?

是的。我們對 Livdelzi 的進步感到非常高興，對嗎？

In our full second quarter, [$40 million]. But, most importantly, it actually has to do with the share uptake that we've seen.

在我們的整個第二季度，[4000萬美元]。但最重要的是，它實際上與我們所看到的份額成長有關。

We are looking at about one-third of the market, today, out of the second-line products that are currently indicated and growing, incredibly, rapidly.

目前，我們關注的是二線產品約佔市場的三分之一，這些產品目前正處於發展階段，且成長速度非常快。

We grew about 10 points share in one quarter. So we are really building that momentum, with a lot of positive feedback that we're getting from our healthcare providers around the efficacy, both the ALP, the biochemical response, and the [pruritus].

我們在一個季度內成長了約 10 個百分點。因此，我們確實在不斷累積這種勢頭，並從我們的醫療保健提供者那裡得到了很多關於療效的正面回饋，包括 ALP、生化反應和[搔癢症]。

And coverage, right, now, is in line with our expectations. So we're at about just over 80% or so coverage with commercial plans. And we think that's going to keep growing, probably, within the next couple of months to just well above 90%.

目前的覆蓋範圍符合我們的預期。因此，我們的商業計劃覆蓋率約為 80% 左右。我們認為，這一數字可能會在未來幾個月內繼續增長，直至略高於 90%。

So I think, right now, we're well on our way to continue to drive Livdelzi and really differentiate it in PBC.

所以我認為，現在我們正在順利地繼續推動 Livdelzi 的發展，並真正使其在 PBC 中脫穎而出。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

Great. Thanks for taking the question.

偉大的。感謝您回答這個問題。

I noticed -- and you mentioned -- that you added MRD-negativity as a co-primary endpoint in the anito-cel Phase 3 trial.

我注意到——您也提到過——您在 anito-cel 第 3 階段試驗中添加了 MRD 陰性作為共同主要終點。

I'm just wondering what -- if you could comment on what the regulators would want to see there to approve that, on an MRD-negativity endpoint, in terms of, like, what delta you would need or if you'd also have to have other supportive data to justify an approval.

我只是想知道——您是否可以評論一下監管機構希望看到什麼來批准 MRD 陰性終點，例如，您需要什麼增量，或者您是否還必須有其他支持數據來證明批准是合理的。

Thank you.

謝謝。

Right, Terrence. It's Cindy Perettie.

對的，特倫斯。她是辛蒂·佩雷蒂。

We don't comment on the delta that they're looking for. But what I would share is that this is a dual primary endpoint. And so, being able to use MRD -- we know, today, that that correlates to [PFS] and it also allows us to, assess, within months of the treatment, if the patient is having a response.

我們不對他們所尋找的增量進行評論。但我想分享的是，這是一個雙重主要終點。因此，能夠使用 MRD——我們今天知道，這與 [PFS] 有關，並且還使我們能夠在治療後的幾個月內評估患者是否有反應。

So our goal is to use the MRD-negativity endpoint, first. And then, follow that up with progression-free survival.

因此，我們的目標是首先使用 MRD 陰性終點。然後，追蹤無惡化存活期。

But the correlation between the two is what we're talking to regulators about.

但我們正在與監管機構討論的是兩者之間的關聯。

Tim Anderson, BofA.

美國銀行的蒂姆·安德森。

Thank you.

謝謝。

On Descovy, how much will in lenacapavir for PrEP cannibalize? Could US Descovy sales go ex-growth, as soon as 2026?

在 Descovy 上，用於 PrEP 的 lenacapavir 會蠶食多少？美國 Descovy 銷量能否在 2026 年停止成長？

And then, can you just give us any ballpark estimate for how many patients could be on lenacapavir for PrEP by the end of the year?

然後，您能否給我們一個大致的估計，到今年年底將有多少患者可以使用 lenacapavir 進行 PrEP 治療？

Thanks for the question, Tim.

謝謝你的提問，提姆。

Yeah. We don't give product-specific guidance. But here's what I can say: I do think that, as you think about lenacapavir and its offering of twice-a-year, there really is an opportunity when you think about a [switch-switch] strategy, right?

是的。我們不提供特定產品的指導。但我可以說的是：我確實認為，當你考慮利那帕韋及其一年兩次的治療方案時，當你考慮[轉換-轉換]策略時，確實存在機會，對嗎？

When you think about 95% of the market today are daily orals -- which, obviously, that includes Descovy and generic Truvada. And so, that will definitely be where I think the first patients come through.

想想看，目前市面上 95% 的藥物都是每日口服藥物——這顯然包括 Descovy 和仿製 Truvada。所以，我認為第一批病人肯定就是從那裡來的。

In addition to naïve patients, naïve folks, as well, that have been waiting for lenacapavir. Because there is definitely a lot of noise in the system, from the communities, that people are hanging in there until the approval of lenacapavir. So those two pieces are what's exciting, as we think about the launch.

除了天真的患者外，還有天真的普通人也在等待利那帕韋。因為系統中肯定存在著許多來自社區的噪音，人們正在等待利那帕韋的批准。因此，當我們考慮發佈時，這兩件事是令人興奮的。

And as I think about the growth of this market, right, we've basically said that we're just over about 400,000 to 450,000 folks or so on PrEP, today, in the US. We think that number will definitely continue to grow, quite rapidly, especially with the acceleration -- I think it will accelerate with the launch of lenacapavir.

當我思考這個市場的成長時，我們基本上可以說，今天在美國，大約有 40 萬到 45 萬人使用 PrEP。我們認為這個數字肯定會繼續增長，而且增長得相當快，尤其是隨著 lenacapavir 的推出而加速增長。我認為這個數字將會隨著 lenacapavir 的推出而加速成長。

And I think that number could be quite exponential, as you think about the next 10 years or so. So we're looking forward to seeing a little bit more in growth.

我認為，如果考慮未來 10 年左右，這個數字可能會呈指數級增長。因此，我們期待看到更多的成長。

As we're 16% year on year, today, I think you're going to see a bit of an acceleration, as you think about the lenacapavir launch around the corner.

由於我們今天的年增長率為 16%，所以，當你想到即將推出的 lenacapavir 時，我認為你會看到一點加速。

Evan Seigerman, BMO.

埃文·西格曼（BMO）。

Oh. Thank you so much for taking my question.

哦。非常感謝您回答我的問題。

I wanted to drill down, a little bit, on some of the dynamics we're seeing in cell therapy. Are you seeing more share or competitive-share capture from competitive cell therapy products or bispecifics?

我想深入探討我們在細胞療法中看到的一些動態。您是否看到競爭性細胞治療產品或雙特異性藥物獲得更多份額或競爭份額？

And the flip side: once folks -- once (inaudible) might use a different cell therapy product, do you tend to see them switch over? What are the dynamics behind that?

另一方面：一旦人們—一旦（聽不清楚）可能會使用不同的細胞治療產品，您是否傾向於看到他們轉換？這背後的動力是什麼？

Thank you so much.

太感謝了。

(inaudible) Perettie. Thank you for the question.

（聽不清楚）佩雷蒂。謝謝你的提問。

I think that we have shared, probably in the previous quarter and this quarter, that we're seeing the dynamics from both bispecifics as well as in-class competition. And I think it depends as you look at Yescarta and Tecartus on those dynamics.

我認為，我們可能在上一季和本季已經分享過，我們看到了雙特異性抗體和同類競爭的動態。我認為這取決於你對 Yescarta 和 Tecartus 的動態的看法。

We have a number of new, approved indications with in-class competition, outside of the US. And that's some of the dynamics you're observing, outside of the US; within the US, in some of the more smaller markets that Tecartus is competing in.

我們在美國以外地區擁有多項新的、已核准的同類競爭藥物。這就是您在美國以外觀察到的一些動態；在美國，在 Tecartus 參與競爭的一些較小的市場中。

We're seeing new indications, as well, with in-class competitors. But we're also seeing new indications in the US and Europe with the bispecific. So it's both that we're observing, right now.

我們也看到了同類競爭對手的新跡象。但我們也在美國和歐洲看到了雙特異性抗體的新適應症。所以我們現在觀察的是兩者。

So, hopefully, that that answers your question.

所以，希望這能回答你的問題。

Matt Biegler, Oppenheimer.

馬特·比格勒，奧本海默。

Great. Thanks so much.

偉大的。非常感謝。

I had another question on Trodelvy and the decreased demand Q-o-Q. Are you seeing any headwind from (inaudible) recent approval in HR-positive?

我對 Trodelvy 和環比需求下降還有另一個問題。您是否看到（聽不清楚）最近對 HR-positive 的批准有任何阻力？

And that kind of leads to a broader question of could you just comment on the patient mix you're treating, in terms of Triple Negative versus HR-positive? Thanks.

這就引出了一個更廣泛的問題：您能否就三陰性和 HR 陽性方面評論一下您正在治療的患者組合？謝謝。

Sure. Basically, with competitive impact, we haven't seen any impact, thus far, really, as we think about new entrants in the marketplace. And we continue to really see a really strong dynamic in Triple Negative Breast Cancer to HR-positive.

當然。基本上，就競爭影響而言，到目前為止，我們還沒有看到任何影響，因為我們考慮的是市場中的新進者。我們繼續看到三陰性乳癌轉變為 HR 陽性乳癌的強勁動態。

Remember, the indications are a little bit different. In Triple Negative, we're looking at a second-line metastatic indication. In HR-positive, HER2-negative, the later lines of therapy, fourth line.

請記住，跡像有點不同。在三陰性中，我們正在研究二線轉移指徵。在 HR 陽性、HER2 陰性的情況下，治療的後期線，第四線。

So we're definitely the TROP2 ADC of choice in HR-positive, HER2-negative versus other ADCs that are used much earlier in line -- in first and second line, for example.

因此，與其他在第一線和第二線治療中更早使用的 ADC 相比，我們絕對是 HR 陽性、HER2 陰性患者的首選 TROP2 ADC。

And then, in Triple Negative Breast Cancer, we are absolutely the ADC of choice in that setting.

然後，在三陰性乳癌中，我們絕對是該環境下的首選 ADC。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

Hi. Well, thanks so much for taking the question.

你好。嗯，非常感謝您回答這個問題。

I just wanted to ask a little bit about the once-yearly lenacapavir. We obviously saw the early data presented at CROI.

我只是想問一下有關一年一次的利那帕韋的問題。我們顯然看到了 CROI 上呈現的早期數據。

It seems, with the timeline associated with that press release, that there could be a different trial design than what we've seen in PURPOSE 1 and PURPOSE 2. Can you just talk about whether there is any potential for an expedited [PK] or [PD] package, relative to an efficacy trial or what might be needed to get once-yearly to market for PrEP?

從與該新聞稿相關的時間表來看，試驗設計似乎與我們在目的 1 和目的 2 中看到的有所不同。您能否談談，相對於功效試驗，是否有可能推出加速的 [PK] 或 [PD] 方案，或者每年一次將 PrEP 推向市場可能需要什麼？

Thanks, Courtney, for the question. That's very insightful, right?

謝謝考特尼提出的問題。這很有見地，對吧？

We are currently looking into the different study designs, right? We have not commented, exactly, on what we're planning on doing, at this point in time.

我們目前正在研究不同的研究設計，對嗎？目前，我們還沒有具體評論我們計劃做什麼。

But you're absolutely right. There are different study designs that you can utilize. And, potentially, a PK-based approach is a possibility that we're discussing.

但你完全正確。您可以利用不同的研究設計。而且，我們正在討論基於 PK 的方法的可能性。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Hi, there. Thanks so much for taking my question.

你好呀。非常感謝您回答我的問題。

A question for Johanna around the potential on the ground dynamics for lenacapavir on PrEP. Can you give us a sense of the awareness, across the target physician practices of the drug, the number of sites or, maybe, proportion of your target practices that are going to be ready to order or administer the drug, at launch; and where provider stands with regards to capacity and bandwidth to administer it?

我向 Johanna 提問有關 lenacapavir 在 PrEP 中的潛在實際動態。您能否向我們介紹目標醫師對該藥物的認知度，以及在藥物上市時準備訂購或管理該藥物的地點數量或目標醫師的比例？提供者在管理它的容量和頻寬方面處於什麼位置？

Thanks.

謝謝。

Okay. I think, from an awareness standpoint, the awareness is actually quite high, both at the healthcare provider level but, also, within the community.

好的。我認為，從意識的角度來看，人們的意識實際上相當高，無論是在醫療保健提供者層面，還是在社區內部。

And I think we're leveraging both of those pieces, as we think about: how do we prepare for our launch?

我認為我們正在利用這兩個部分，因為我們在思考：我們如何為發布做準備？

We're also very targeted, right? We know that about 75% of HIV prescribers are the one prescribing PrEP, today.

我們也非常有針對性，對吧？我們知道，目前約有 75% 的 HIV 處方者是開 PrEP 處方的人。

So, at launch, that's really our target -- is, really, around differentiating lenacapavir versus current options, making sure that we are setting them up for success and creating a very smooth customer experience.

因此，在發佈時，這確實是我們的目標 - 實際上是圍繞區分 lenacapavir 與現有選項，確保我們為它們的成功做好準備並創造非常流暢的客戶體驗。

To your point about number of sites: we've been very targeted on our approach in the first 30 days. We have a 30-day plan, 90-day plan.

關於您提到的站點數量：我們在前 30 天採取的方法非常有針對性。我們有 30 天計劃、90 天計劃。

And we're also very clear -- some clinics are set-up to do buy-and-bill, today; and they, currently, do it. Those are clinics that might be a little bit more open to do buy-and-bill with lenacapavir so we know those and we're making sure that they have all the training necessary to be able to do so, at post-launch.

我們也非常清楚──如今，有些診所已經設立了購買和計費系統；目前，他們也確實這麼做了。這些診所可能對使用利那帕韋進行買單支付更加開放，因此我們了解這些，並確保他們在推出後接受了所有必要的培訓。

But then, you also have a lot of clinics that do not have that set-up. And we'll need to go through a more of a white-bagging process through specialty pharmacy.

但是，也有很多診所沒有這樣的設施。我們需要透過專業藥局進行更嚴格的白袋處理流程。

And the optionality, here, is going to be really important. And that's what we want to make sure we offer; and that we train folks, not just the healthcare providers, to be honest with you but, actually, anybody in the clinic that's managing this.

這裡的可選性非常重要。這正是我們想要確保提供的；並且我們對人員進行培訓，不僅僅是對醫療保健提供者，說實話，實際上對診所中管理此事的任何人進行培訓。

And so, we have a team of folks ready to go. Not just our medical and sales teams but we also have nurse educators making sure people know how to inject, making sure they can help any with any questions they might have; but we also have field reimbursement managers that are going to be in the field, basically making sure that we can track-and-follow to make sure they get reimbursed, especially if you think about the first 6 months or so, as plans are just coming online. It's going to take a little bit of time.

因此，我們有一個隨時準備出發的團隊。我們不僅有醫療和銷售團隊，還有護士教育者，確保人們知道如何注射，確保他們能夠幫助解決任何他們可能遇到的問題；但我們也有現場報銷經理在現場，基本上確保我們能夠跟踪並跟進，以確保他們得到報銷，特別是如果你考慮到前 6 個月左右，因為計劃剛剛上線。這需要一點時間。

And so, most prescriptions will get a medical exception. And we just want to make sure that we're tracking those to make sure we can help clinics and healthcare providers follow through on that so that they can get started on lenacapavir, as quickly as possible.

因此，大多數處方都會獲得醫療例外。我們只是想確保我們正在追蹤這些情況，以確保我們能夠幫助診所和醫療保健提供者跟進，以便他們能夠盡快開始使用利那帕韋。

Mohit Bansal, Wells Fargo.

富國銀行的 Mohit Bansal。

Great. Thank you for taking my question.

偉大的。感謝您回答我的問題。

I would love for you to comment on a couple of macro themes that we hear a lot, as they pertain to Gilead.

我希望您能對我們經常聽到的幾個與吉利德有關的宏觀主題發表評論。

One is, of course, about the NIH funding cuts and potential for funding cuts regarding something which could help with the HIV awareness and PrEP awareness (inaudible).

其中一個當然是關於 NIH 資金削減以及可能削減的資金，這些資金可能有助於提高 HIV 意識和 PrEP 意識（聽不清楚）。

And then, number 2 is potential for Medicaid cuts and how it pertains to Gilead; and if Gilead can actually operate in an environment like that.

然後，第二個問題是醫療補助削減的可能性以及它與吉利德的關係；以及吉利德是否真的可以在這樣的環境中運作。

Thank you.

謝謝。

Thanks. Well, let me start. This is Dan. And then, Johanna can turn me out, as well.

謝謝。好吧，讓我開始吧。這是丹。然後，喬安娜也可以把我趕出去。

I just want to repeat that we haven't seen or heard anything, to date, that would cause us to alter our plans or expectations in the HIV field, including the LEN for PrEP launch.

我只想重申，到目前為止，我們還沒有看到或聽到任何會導致我們改變在愛滋病毒領域的計劃或期望的事情，包括 LEN 推出的 PrEP。

I think it's just too early to speculate on anything related to Medicaid, at this stage. There's no confirmed cuts, at this time.

我認為，現階段對醫療補助相關事宜進行任何推測還為時過早。目前還沒有確認的裁員消息。

I believe the administration understands the importance -- particularly, chronic diseases and prevention -- as they approach that.

我相信政府在處理這個問題時明白其重要性——特別是慢性疾病和預防。

I'd also say, at the CDC side: we're obviously strong supporters of the CDC and, also, the role that NIH plays in creating a scientific community.

我還要說，從 CDC 角度來說，我們顯然是 CDC 的堅定支持者，同時也支持 NIH 在創建科學界中所扮演的角色。

But, specifically, relative to CDC, it's still too early to understand any impact on, particularly, CDC programs. They're generally focused on supporting PrEP utilization with community outreach, providing training and education. Those are also things that we do as well.

但具體來說，相對於 CDC，現在了解其對 CDC 計畫的影響還為時過早。他們通常致力於透過社區推廣、培訓和教育來支持 PrEP 的使用。這些也是我們所做的事情。

And, maybe, I'll turn it over to Johanna to say how she sees it, in terms of how some of our programs may be able to make sure that services are delivered to the people that need these medicines.

也許，我會讓喬安娜談談她的看法，關於我們的一些項目如何確保為需要這些藥物的人提供服務。

Thanks, Dan.

謝謝，丹。

Yeah. We've been tracking this, very closely; and, obviously, making sure that the work that we do continues; and, in some areas, gets accelerated or elevated where necessary -- where there might be some gaps where necessary and where HIV incidences may be higher as well, right, where there's a greater need.

是的。我們一直在密切關注此事；顯然，還要確保我們的工作能夠繼續下去；並且，在某些地區，必要時會加速或提高——在必要時可能會有一些差距，而且艾滋病毒發病率也可能更高，對，在有更大需求的地方。

So we're very targeted in our approach.

因此我們的方法非常有針對性。

And then, just going back to -- obviously, there's nothing in sight and we wouldn't speculate about anything around Medicaid.

然後，回到正題——顯然，目前還沒有任何進展，我們也不會對醫療補助做出任何猜測。

But I just want to remind everybody this: we're talking about HIV. These are individuals that if they need access to HIV medicines, they will find other channels for coverage. Because if they don't; unfortunately, HIV will turn into AIDS and they will die.

但我只想提醒大家：我們在談論愛滋病毒。如果這些人需要獲得愛滋病毒藥物，他們會尋找其他管道獲得治療。因為如果他們不這樣做；不幸的是，愛滋病毒會發展成愛滋病，他們就會死亡。

And so, in the past, what we have seen is if one channel is closed, they go to another. And there are many different channels where they can they can go to today, including some Federal but some state-funded approaches, as well as Gilead programs, that they can just make sure that they get over these access barriers.

因此，在過去，我們看到的是，如果一個頻道關閉，他們就會轉向另一個管道。如今，他們可以透過許多不同的管道獲得治療，包括一些聯邦政府和一些州政府資助的方案，以及吉利德的項目，這樣他們就可以確保克服這些獲取障礙。

So I just wanted to pause on that.

所以我只是想暫停一下。

Alex Hammond, Wolfe.

亞歷克斯·哈蒙德，沃爾夫。

Thanks for taking the question.

感謝您回答這個問題。

How should we think about the potential impact of the 340B channel mix on HIV pricing for '25? And how do you expect utilization to compare to what was seen in 2024?

我們該如何看待 340B 通路組合對 25 年 HIV 定價的潛在影響？您預計利用率與 2024 年相比如何？

Thank you.

謝謝。

Again, at this time, there is nothing new that we are seeing for 340B. We've seen a growth, actually, of 340B over '20 -- in every quarter, from '24 into 2025. We hope that stabilizes.

再說一次，目前我們還沒有看到任何關於 340B 的新消息。實際上，我們看到 2020 年的成長量為 3,400 億美元——從 2024 年到 2025 年，每季都是如此。我們希望情況能夠穩定下來。

We believe in the 340B channel, absolutely, for what it was designed, originally, to do. We just want a little bit more transparency because that would really help cut out some of the duplicates that we're currently seeing as well, across some of our different therapeutic areas.

我們完全相信 340B 通道能夠完成其最初的設計目的。我們只是希望提高一點透明度，因為這確實有助於消除我們目前在不同治療領域看到的一些重複現象。

Simon Baker, Redburn Atlantic.

西蒙貝克 (Simon Baker)，雷德伯恩大西洋公司 (Redburn Atlantic)。

Thanks for taking my question.

感謝您回答我的問題。

Going back to the Part D redesign. We've talked about the impact. I'm just wondering if could you give us some thoughts on when you are expecting to see a potential benefit, as the lower cost to patients increases starts and increases stay time.

回到 D 部分的重新設計。我們已經討論過其影響。我只是想知道您是否可以告訴我們您預計何時會看到潛在的好處，因為患者成本的降低會增加開始治療的時間並增加停留時間。

I'm guessing it's too early now. But as the year goes on, when should we start to see an offsetting positive impact from the changes that have been made?

我猜現在還太早。但隨著時間的推移，我們何時才能開始看到這些變化帶來的正面影響？

Thanks so much.

非常感謝。

Yeah. Thanks for the question.

是的。謝謝你的提問。

In terms of volume, given the number of safety nets that I was just referring to earlier, there's so many programs that are available, today, that exist for HIV.

從數量上看，考慮到我之前提到的安全網的數量，目前有許多針對愛滋病毒的計畫。

We're not expecting to see a material uptick from the Part D reform. We're obviously going to track it super closely.

我們並不期望看到 D 部分改革帶來實質的提升。我們顯然會密切關注此事。

If we were to see it, it would be later in the year. And just to remind people: when you look at Biktarvy, for example, the level of abandonment of Biktarvy is incredibly low today. And so, very different, maybe, than other therapeutic areas that you might see in chronic diseases, just because of the consequences of not being on an HIV treatment.

如果我們能看到它，那將在今年晚些時候。只是提醒大家：例如，當你看看 Biktarvy 時，你會發現今天 Biktarvy 的放棄率非常低。因此，這可能與你在慢性病中看到的其他治療領域非常不同，只是因為不接受 HIV 治療的後果。

And so, that's why we're monitoring the situation. We haven't included it in our numbers, like we've shared in the past. And we'll obviously -- if we do see something, we'll share it with you, as soon as we do.

這就是我們監視局勢的原因。我們沒有將其包括在我們的數字中，就像我們過去分享的那樣。顯然，如果我們確實發現了什麼，我們會盡快與你們分享。

But if it was to happen, it would be later in the year.

但如果真的發生，那也得在今年晚些時候了。

That completes the time that we have for questions, today.

今天我們的提問時間到此結束。

I'll now invite Dan to share any closing remarks.

現在我邀請丹發表結束語。

Terrific, everybody. Let me wrap up by thanking the Gilead teams that are responsible for this great start to the year.

太棒了，大家。最後，我要感謝吉利德團隊為今年的良好開端做出的貢獻。

I'll just say that, on behalf of all of us, the strong base business growth of 4% year over year and 6% growth in our HIV business, combined with the continued success of the Livdelzi launch and growing demand for Trodelvy, alongside the impressive operating margin and earnings per share, all demonstrate that we have a strong and efficient business today, which I think is extremely important, given the current environment that we're all operating in.

我只想代表我們所有人說，基礎業務同比增長 4%，HIV 業務增長 6%，再加上 Livdelzi 的持續成功推出和對 Trodelvy 的需求不斷增長，再加上令人印象深刻的營業利潤率和每股收益，所有這些都表明我們今天擁有強大而高效的業務，考慮到我們目前所處的運營環境，我認為這非常重要。

And, moving forward, we're also excited about what's next: our diverse pipeline and generating multiple upcoming potential launches, including lenacapavir for PrEP, which is weeks away; Livdelzi in further markets; anito-cel; and, now, Trodelvy, based on the positive Phase 3 results from the ASCENT-04 study, all fill us with great promise, as we continue on a diversification approach and confidence in our business, overall.

展望未來，我們也對接下來的事情感到興奮：我們多樣化的產品線和即將推出的多個潛在產品，包括幾週後推出的 PrEP 藥物 lenacapavir； Livdelzi 在進一步的市場中； anito-cel；現在，基於 ASCENT-04 研究的第三階段積極結果，Trodelvy 都讓我們充滿希望，因為我們將繼續採取多元化的方法。

So this is an exciting time for Gilead: the ongoing work that we all do for patients in the communities we serve.

因此，對於吉利德來說，這是一個激動人心的時刻：我們所有人都在為我們服務的社區的患者持續努力。

And I just want to close by thanking you all for joining us, today. We look forward to keeping you up-to-date on our progress, as the year continues.

最後，我要感謝大家今天的參與。隨著時間的推移，我們期待向您通報我們的進展。