吉利德科學 (GILD) 2024 Q4 法說會逐字稿

內容摘要

吉利德公佈了 2024 年第四季度和全年強勁的財務業績,收入增長且利潤大幅增長。該公司在愛滋病毒、肝病、腫瘤學和細胞治療領域表現出色,且其產品線取得了令人欣喜的進展。

吉利德任命了一位新首席醫療官,並為 2025 年聯邦醫療保險 D 部分模式的變化做準備。

預計來年將會取得令人興奮的里程碑,包括監管決策和各種治療方法的更新。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon, everyone, and welcome to Gilead's fourth quarter and full year 2024 earnings conference call.

    大家下午好,歡迎參加吉利德 2024 年第四季和全年財報電話會議。

  • My name is Rebekah, and I'll be today's host.

    我叫麗貝卡,是今天的主持人。

  • In a moment, we'll begin our prepared remarks, followed by our Q&A session.

    稍後我們將開始準備好的發言,然後是問答環節。

  • (Operator Instructions)

    (操作員指令)

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

    現在我將電話轉給財務和投資者關係資深副總裁 Jacquie Ross。

  • Jacquie Ross - Investor Relations

    Jacquie Ross - Investor Relations

  • Thank you, Rebekah.

    謝謝你,麗貝卡。

  • Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year of 2024.

    今天市場收盤後不久,我們發布了一份新聞稿,其中包含 2024 年第四季和全年的獲利結果。

  • The press release, slides and supplementary data are available on the Investors section of our website at Gilead.com.

    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.

    今天電話會議的發言人是我們的董事長兼執行長丹尼爾‧奧戴 (Daniel O’Day);我們的首席商務官 Johanna Mercier;我們的首席醫療官 Dietmar Berger;以及我們的財務長安德魯·迪金森(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.

    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.

    讓我提醒您,我們將做出前瞻性陳述。

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

    請參閱投影片 2,以了解有關前瞻性陳述的風險和不確定性,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,我會把電話轉給丹。

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Thank you, Jacquie, and good afternoon, everyone.

    謝謝你,杰奎琳,大家下午好。

  • I'm pleased to share Gilead's very strong fourth quarter and full year results, which highlight growing revenues and exceptional bottom line growth.

    我很高興與大家分享吉利德非常強勁的第四季和全年業績,這突顯了其收入的成長和卓越的利潤成長。

  • Starting with our full year performance.

    從我們的全年業績開始。

  • Total product sales, excluding Veklury increased 8% year-over-year to $26.8 billion.

    不包括 Veklury 在內的總產品銷售額年增 8%,達到 268 億美元。

  • And fourth quarter 2024 total product sales, excluding Veklury, increased 13% year-over-year to $7.2 billion.

    2024 年第四季(不包括 Veklury)的總產品銷售額年增 13%,達到 72 億美元。

  • Full year HIV sales grew 8% in 2024 to $19.6 billion, significantly ahead of our expectation to grow HIV 5% in 2024.

    2024 年全年 HIV 銷售額將成長 8%,達到 196 億美元,大大高於我們預期的 2024 年 HIV 銷售額成長 5%。

  • Full year sales for Biktarvy, the standard of care for HIV treatment, grew 13%.

    愛滋病治療標準藥物 Biktarvy 的全年銷售額成長了 13%。

  • In recent years, our HIV business has established a track record of consistently strong growth with 5% growth in 2022, 6% in 2023 and now 8% in 2024.

    近年來,我們的 HIV 業務保持了持續強勁增長的記錄,2022 年增長 5%,2023 年增長 6%,2024 年增長 8%。

  • This is driven by the strength of our innovation and by the consistently strong execution of our team.

    這是由我們的創新實力和我們團隊一貫強勁的執行力所推動的。

  • In 2025, while volume and demand growth will continue, we can expect to see a temporary masking of the trend with the anticipated impact of Medicare Part D reform on revenue growth.

    到 2025 年,雖然數量和需求將繼續增長,但我們可以預計,由於 Medicare Part D 改革預計會對收入增長產生影響,這一趨勢將暫時被掩蓋。

  • This will effectively reset the base from which our HIV business will continue to grow from 2025.

    這將有效地重新設定我們的愛滋病毒業務自2025年起繼續成長的基礎。

  • We fully expect to see our leadership in HIV continue and extend beyond the 2030s based on our long-acting portfolio, of which lenacapavir is the foundation.

    我們完全有信心,憑藉以利那帕韋為基礎的長效藥物組合,我們在愛滋病毒領域的領導地位能夠持續下去,並延續到2030年代以後。

  • In December, we filed for approval of lenacapavir for twice-yearly HIV prevention in the US, where it has Breakthrough Therapy designation, and we continue to make progress on our global filings.

    12 月,我們在美國提交了 lenacapavir 用於每年兩次愛滋病預防的申請,該藥物在美國被認定為突破性治療藥物,並且我們的全球申請繼續取得進展。

  • At the end of January, we filed for approval with the European Medicines Agency, and our submission will be assessed under an accelerated review timeline.

    一月底,我們向歐洲藥品管理局提交了批准申請,我們的申請將根據加速審查時間表進行評估。

  • Given the unprecedented efficacy in the Phase 3 PURPOSE 1 and PURPOSE 2 trials and the significant potential that exists in HIV prevention, we are looking forward to delivering on this global opportunity in 2025 and beyond.

    鑑於第 3 階段 PURPOSE 1 和 PURPOSE 2 試驗前所未有的功效以及在愛滋病毒預防方面存在的巨大潛力,我們期待在 2025 年及以後抓住這一全球機遇。

  • As we shared at our HIV Analyst Day in December, we have a broad and unmatched clinical program for both HIV treatment and prevention that builds on what we currently offer with Biktarvy and Descovy.

    正如我們在 12 月的 HIV 分析師日上所分享的那樣,我們擁有一項廣泛且無與倫比的 HIV 治療和預防臨床計劃,該計劃以我們目前提供的 Biktarvy 和 Descovy 為基礎。

  • We expect to deliver up to 7 potential new HIV treatment options and 2 prevention options before the end of 2033, including new daily, weekly, and monthly orals as well as quarterly and twice-yearly injectables.

    我們預計在 2033 年底之前提供多達 7 種潛在的新 HIV 治療方案和 2 種預防方案,包括新的每日、每周和每月口服藥物以及每季和每年兩次的注射藥物。

  • We look forward to sharing a number of HIV clinical updates this year, including updates from ARTISTRY-1 in people with HIV on complex regimens; and the Phase 2 portion of our WONDERS-1 trial, evaluating a potential once-weekly HIV treatment option.

    我們期待今年分享一些愛滋病毒臨床更新,包括 ARTISTRY-1 對接受複雜方案的愛滋病毒患者進行的更新;以及我們的WONDERS-1試驗的第2階段部分,評估潛在的每週一次的HIV治療方案。

  • Moving to inflammation the fourth quarter of 2024 was the first full quarter's commercial launch for Livdelzi in the United States, and we are extremely pleased with the results.

    轉向炎症,2024 年第四季度是 Livdelzi 在美國進行商業發布的第一個完整季度,我們對結果非常滿意。

  • The strong sales of approximately $30 million for the quarter underscore the important differentiation that Livdelzi brings to people with primary biliary cholangitis.

    本季約 3,000 萬美元的強勁銷售額凸顯了 Livdelzi 為原發性膽汁性膽管炎患者帶來的重要差異化。

  • And we expect the European Commission decision later this month following the CHMP recommendation for Livdelzi in December.

    我們預計,繼 CHMP 於 12 月針對 Livdelzi 提出建議後,歐盟委員會將於本月稍後做出決定。

  • Our liver portfolio, which amounts to a $3 billion business today, is a steady contributor for Gilead, and we look forward to seeing it evolve with the new impetus of Livdelzi.

    我們的肝臟產品組合如今已達到 30 億美元的業務,為吉利德帶來了穩定的貢獻,我們期待看到它在 Livdelzi 的新動力下不斷發展。

  • We also continue to make progress across our early and promising inflammation pipeline.

    我們也在早期且有前景的發炎研究領域繼續取得進展。

  • This includes the recent addition of our STAT6 program from LEO Pharma and the advancement of our bicistronic CAR T targeting CD19 and CD20 for autoimmune diseases.

    其中包括我們最近從 LEO Pharma 添加的 STAT6 計畫以及我們針對 CD19 和 CD20 治療自體免疫疾病的雙順反子 CAR T 的進展。

  • In oncology, we continue to make progress on expanding the reach of our cell therapies to the many additional patients who could benefit from a one-time therapy in these challenging hematological malignancies.

    在腫瘤學領域,我們不斷取得進展,將細胞療法的覆蓋範圍擴大到更多可以從這些具有挑戰性的血液系統惡性腫瘤的一次性治療中受益的患者。

  • And at the same time, our collaboration with Arcellx on anito-cel continues to yield promising results.

    同時,我們與Arcellx在anito-cel方面的合作繼續取得令人欣喜的成果。

  • Data from the registrational Phase 2 iMMagine-1 trial were shared at the ASH meeting in December, where anito-cel demonstrated its potential to be a best-in-class BCMA CAR T therapy.

    12 月的 ASH 會議上分享了註冊第 2 階段 iMMagine-1 試驗的數據,anito-cel 展示了其成為一流 BCMA CAR T 療法的潛力。

  • We continue to target commercial launch in 2026 and have separately dosed our first patient in the Phase 3 iMMagine-3 trial in the second to fourth line setting.

    我們繼續以 2026 年實現商業化為目標,並在第三階段 iMMagine-3 試驗的第二至第四線環境中分別對第一位患者進行了給藥。

  • Trodelvy, meanwhile, remains the only approved TROP2 ADC to demonstrate overall survival benefit in pretreated HR-positive, HER2-negative metastatic breast cancer and in second-line metastatic triple-negative breast cancer.

    同時,Trodelvy 仍然是唯一獲得批准的 TROP2 ADC,在接受治療的 HR 陽性、HER2 陰性轉移性乳癌和二線轉移性三陰性乳癌中顯示出整體生存益處。

  • Additionally, Trodelvy has 6 ongoing Phase 3 trials with updates from the ASCENT-03 and ASCENT-04 trials in first-line metastatic, triple-negative breast cancer expected this year.

    此外,Trodelvy 還有 6 項正在進行的 3 期試驗,預計今年將更新針對第一線轉移性三陰性乳癌的 ASCENT-03 和 ASCENT-04 試驗。

  • We also anticipate initiating another Phase 3 trial for Trodelvy in extensive-stage small cell lung cancer patients later this year.

    我們也預計今年稍後針對廣泛期小細胞肺癌患者啟動 Trodelvy 的另一項 3 期試驗。

  • Our many near-term opportunities across HIV, oncology and inflammation will help to drive the next wave of growth for Gilead.

    我們在愛滋病毒、腫瘤學和發炎領域的眾多近期機會將有助於推動吉利德的下一波成長。

  • We have no major loss of exclusivity until late 2033, and we have significant potential across the entire portfolio.

    在 2033 年底之前,我們的獨家經營權不會遭受重大損失,而且我們整個投資組合都具有巨大的潛力。

  • With that in mind, I'm delighted to introduce our new Chief Medical Officer, Dietmar Berger, who joined us in early January.

    考慮到這一點,我很高興介紹我們的新任首席醫療官迪特馬爾·伯傑 (Dietmar Berger),他於 1 月初加入我們。

  • Dietmar's exceptional leadership in global drug development, his track record in delivering transformational therapies and the breadth and depth of his experience make him an ideal leader for taking us through the next chapter for Gilead, and I know you will all enjoy getting to know him in the months ahead.

    迪特馬爾在全球藥物開發方面的卓越領導力、他在提供轉化療法方面的業績以及他豐富而深入的經驗使他成為帶領吉利德邁下一篇章的理想領導者,我知道你們都會很高興在未來的幾個月裡認識他。

  • I would also like to thank Merdad Parsey for his contributions to Gilead over the last 5 years and wish him the very best for his retirement.

    我還要感謝 Merdad Parsey 過去五年來對吉利德的貢獻,並祝他退休後一切順利。

  • Among his many achievements, Merdad developed a world-class team that has helped to build the most robust and diversified pipeline in Gilead's history, now with 54 ongoing clinical programs, up from just 32 clinical programs in 2019.

    在他的眾多成就中,默達德組建了一支世界一流的團隊,幫助吉利德建立了歷史上最強大、最多樣化的產品線,目前擁有 54 個正在進行的臨床項目,而 2019 年只有 32 個臨床項目。

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

    說完這些,我就把它交給了喬安娜。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Dan, and good afternoon, everyone. 2024 was another exceptional year of commercial execution for Gilead, marking the third consecutive year of high single-digit percentage growth in our base business with sales up 8% year-over-year.

    謝謝,丹,大家下午好。 2024 年是吉利德商業執行的又一個卓越年份,標誌著我們基礎業務連續第三年實現高個位數百分比成長,銷售額年增 8%。

  • Gilead's commercial success underscores the dedication of so many teams across the company, and I'd like to recognize them all for contributing to another outstanding quarter and closing out a very successful year.

    吉利德的商業成功凸顯了公司眾多團隊的奉獻精神,我要感謝他們所有人為另一個出色的季度和非常成功的一年所做的貢獻。

  • Beginning on slide 7, with our fourth quarter results, total product sales, excluding Veklury, were $7.2 billion, an increase of 13% year-over-year, driven by higher HIV product sales as well as growth in our oncology and liver disease portfolios.

    從第 7 張投影片開始,根據我們的第四季業績,不包括 Veklury 在內的總產品銷售額為 72 億美元,同比增長 13%,這得益於 HIV 產品銷售額的增加以及腫瘤學和肝病產品組合的增長。

  • Including Veklury, total product sales grew 7% year-over-year, reflecting the impact of lower COVID-related hospitalizations on Veklury sales.

    包括 Veklury 在內,總產品銷售額年增 7%,反映了 COVID 相關住院人數減少對 Veklury 銷售的影響。

  • Turning to the full year on slide 8, total product sales, excluding Veklury, were $26.8 billion, well above the high end of our 5% to 6% growth guidance range, reflecting strong performance in each of our core therapeutic areas.

    回顧第 8 張投影片上的全年業績,不包括 Veklury 在內的總產品銷售額為 268 億美元,遠高於我們 5% 至 6% 的成長指導範圍的高端,反映了我們在每個核心治療領域的強勁表現。

  • Including Veklury, total product sales were $28.6 billion, a 6% growth rate compared to 2023.

    包括 Veklury 在內,總產品銷售額為 286 億美元,與 2023 年相比成長率為 6%。

  • Moving to slide 9, our HIV business once again delivered very strong results for the fourth quarter with sales of $5.5 billion, up 16% year-over-year, primarily driven by demand as well as higher average realized price and favorable inventory dynamics.

    第 9 頁,我們的 HIV 業務在第四季度再次取得了非常強勁的業績,銷售額達 55 億美元,同比增長 16%,這主要得益於需求、更高的平均實現價格和有利的庫存動態。

  • Sequentially, HIV sales were up 7%, reflecting typical seasonal inventory dynamics and higher demand, partially offset by lower average realized price.

    與上一季相比,HIV 銷售額成長了 7%,反映了典型的季節性庫存動態和更高的需求,但平均實現價格的下降部分抵消了這一增長。

  • In treatment, Biktarvy continues to go from strength to strength with 21% year-over-year sales growth.

    在治療方面,Biktarvy 繼續不斷發展壯大,銷售額年增 21%。

  • Biktarvy now commands over 50% share in the US market and maintains its position as the regimen of choice across other major G9 markets.

    Biktarvy 目前佔據美國市場 50% 以上的份額,並繼續保持其在其他主要 G9 市場首選治療方案的地位。

  • Descovy also delivered 21% year-over-year growth and maintained over 40% US market share in PrEP despite the availability of other regimens, including generics.

    Descovy 也實現了 21% 的同比增長,儘管還有仿製藥等其他藥物可供選擇,但仍保持了 40% 以上的美國 PrEP 市場份額。

  • As a reminder, PrEP accounts for the majority of Descovy revenues.

    需要提醒的是,PrEP 佔了 Descovy 收入的大部分。

  • We're pleased to see payers continue to recognize the benefits of PrEP as barriers to Descovy coverage are removed with over 85% of lives now covered without the need for step edit or prior authorization.

    我們很高興看到付款人繼續認識到 PrEP 的好處,因為 Descovy 覆蓋的障礙被消除,現在超過 85% 的生活得到覆蓋,而無需步驟編輯或事先授權。

  • On slide 10, full year sales of $19.6 billion were up 8% year-over-year with the majority of the growth driven by higher demand as well as higher average realized price.

    第 10 頁顯示,全年銷售額為 196 億美元,年增 8%,大部分成長得益於需求成長以及平均實現價格上漲。

  • More broadly, the HIV treatment market grew around 3% in 2024, consistent with our expectations of a 2% to 3% market growth annually.

    更廣泛地說,愛滋病毒治療市場在 2024 年將成長約 3%,與我們對每年 2% 至 3% 的市場成長率的預期一致。

  • In prevention, market growth accelerated and increased over 16% year-over-year in the fourth quarter, highlighting growing demand for HIV prevention options, which is particularly exciting to see ahead of our potential launch of lenacapavir for prevention in the summer.

    在預防方面,第四季度市場成長加速,年增超過 16%,凸顯了對愛滋病預防選擇的需求不斷增長,在我們可能於夏季推出用於預防的雷那卡帕韋之前看到這一點尤其令人興奮。

  • Preparation activities for the US launch are well underway, and we have also recently submitted Marketing Authorization Applications to the European Medicines Agency for lenacapavir for PrEP across the EU.

    美國上市的準備活動正在有條不紊地進行中,我們最近也向歐洲藥品管理局提交了用於歐盟範圍內 PrEP 的 lenacapavir 行銷授權申請。

  • We can't wait to make this unique prevention option available as we look to redefine the PrEP market in the years ahead.

    我們迫不及待地想要推出這種獨特的預防選擇,因為我們期待在未來幾年重新定義 PrEP 市場。

  • On slide 11, we highlight the impact of the 2025 transition to the new Medicare Part D model.

    在投影片 11 上,我們重點介紹了 2025 年向新 Medicare Part D 模型過渡的影響。

  • As a reminder, the changes include: first, the requirement that manufacturers provide discounts towards the cost of drugs for Medicare patients during the initial coverage and catastrophic phases; and second, the introduction of manufacturer discounts for people who qualify for the low-income subsidy program, or LIS.

    提醒一下,這些變化包括:首先,要求製造商在初始覆蓋和災難階段為醫療保險患者提供藥品費用折扣;其次,為符合低收入補貼計劃(LIS)條件的人提供製造商折扣。

  • This population is disproportionately impacted by HIV, hence, this impact on our business due to the larger cost-sharing obligations.

    該族群受到愛滋病毒的影響尤其嚴重,因此,由於更大的成本分攤義務,我們的業務受到了影響。

  • As these changes are implemented, our 2025 revenue will be impacted by approximately $1.1 billion, of which almost $900 million is in HIV.

    隨著這些變化的實施,我們 2025 年的收入將受到約 11 億美元的影響,其中近 9 億美元用於愛滋病毒治療。

  • As a result, and consistent with prior updates, we expect HIV revenue to be roughly flat in 2025, masking the robust demand-led volume growth that we've seen consistently over the last several years in HIV and expect to continue through 2025 and into 2026 and beyond.

    因此,與先前的更新一致,我們預計 2025 年 HIV 收入將基本持平,掩蓋過去幾年 HIV 領域持續出現的強勁需求主導的數量增長,預計這種增長將持續到 2025 年、2026 年及以後。

  • Excluding this Medicare transition and FX headwinds, our expected HIV revenue growth in 2025 would have been at least 5%, reflecting our continued expectations for strong demand-led volume growth, but offset in part by less favorable pricing assumptions due to channel mix.

    排除醫療保險轉型和外匯逆風因素,我們預計 2025 年 HIV 收入成長率將至少達到 5%,這反映了我們對強勁需求帶動銷售成長的持續預期,但由於通路組合導致的定價假設不太有利,部分抵消了這一增長。

  • With regards to the first quarter of 2025 specifically, we'll remind you to expect the normal HIV seasonal inventory drawdown as well as the impact of the reset of patient co-pays and deductibles on average realized price and market growth.

    具體到 2025 年第一季度,我們提醒您預期正常的 HIV 季節性庫存下降以及患者共付額和免賠額重置對平均實現價格和市場成長的影響。

  • Combined with the projected IRA impact, we expect HIV revenue to decline in the mid-teen percentage range quarter-over-quarter compared to the very strong revenue delivered in the fourth quarter.

    結合預計的 IRA 影響,我們預計與第四季度非常強勁的收入相比,HIV 收入將環比下降百分之十幾。

  • Overall, performance of both Biktarvy and Descovy for both the quarter and full year highlight Gilead's unparalleled position in the HIV market, both in terms of the clinical profile of our therapies as well as our best-in-class HIV commercialization team.

    總體而言,Biktarvy 和 Descovy 本季和全年的表現凸顯了吉利德在 HIV 市場無與倫比的地位,無論是在我們療法的臨床概況方面,還是在我們一流的 HIV 商業化團隊方面。

  • Moving to liver disease on Slide 12, fourth quarter sales of $719 million were up 4% year-over-year, reflecting our strong launch of Livdelzi in PBC and increased demand for HBV and HDV products, partially offset by lower HCV sales due to fewer patient starts.

    轉到幻燈片 12 上的肝病業務,第四季度銷售額為 7.19 億美元,年增 4%,這反映了我們在 PBC 領域強勢推出 Livdelzi 以及對 HBV 和 HDV 產品的需求增加,但由於患者數量減少導致 HCV 銷售額下降,部分抵消了這一影響。

  • Sequentially, sales were down 2% primarily driven by lower HCV sales due to lower average realized price and the timing of purchases, partially offset by higher sales in PBC and HBV.

    環比銷售額下降 2%,主要由於平均實現價格較低以及購買時機不佳導致 HCV 銷售額下降,但 PBC 和 HBV 銷售額的增加部分抵消了這一影響。

  • Full year sales of $3 billion were up 9% year-over-year primarily driven by higher demand across our liver disease portfolio.

    全年銷售額為 30 億美元,年增 9%,主要得益於我們肝病產品組合的需求增加。

  • Viral hepatitis remains an important steady contributor to Gilead's revenue with our products maintaining leading share across major markets.

    病毒性肝炎仍然是吉利德收入的重要穩定貢獻者,我們的產品在主要市場中保持領先份額。

  • I'm also pleased to provide an update on the early launch progress of Livdelzi on Slide 13, which received accelerated approval in the US in August for the treatment of PBC.

    我也很高興在幻燈片 13 上提供 Livdelzi 早期上市進展的最新情況,該藥物於 8 月在美國獲得加速批准,用於治療 PBC。

  • In its first full quarter of commercial availability, Livdelzi sales were $30 million with demand outpacing our expectations and strong early brand share.

    在上市的第一個完整季度,Livdelzi 的銷售額為 3000 萬美元,需求超出了我們的預期,並且早期品牌份額強勁。

  • As the only approved therapy with statistically significant improvements in both ALP and pruritus as well as a demonstrated safety profile, we are excited to see how this positive lunch momentum evolves in 2025.

    作為唯一獲準的治療方法,該療法在 ALP 和搔癢症方面均具有統計意義的顯著改善,並且具有明顯的安全性,我們很高興看到這種積極的治療勢頭在 2025 年將如何發展。

  • Outside of the US, last month, the MHRA in the UK approved Livdelzi for the treatment of PBC, including pruritus.

    在美國以外,上個月,英國 MHRA 批准 Livdelzi 用於治療 PBC,包括搔癢症。

  • Livdelzi also received a positive CHMP opinion in December, and we expect a final decision from the European Commission later this month.

    Livdelzi 在 12 月也收到了 CHMP 的積極意見,我們預計歐盟委員會將於本月稍後做出最終決定。

  • We're excited for these positive steps in Livdelzi's development to bring this important treatment to patients globally.

    我們很高興看到 Livdelzi 在發展過程中取得了這些積極進展,為全球患者帶來這種重要的治療方法。

  • Moving to slide 14, Veklury fourth quarter sales of $337 million were down 53% year-over-year and 51% sequentially primarily due to lower rates of COVID-19 hospitalizations and typical of the quarterly variability we've seen with COVID-19.

    轉到投影片 14,Veklury 第四季的銷售額為 3.37 億美元,年減 53%,環比下降 51%,這主要是由於 COVID-19 住院率較低,並且是 COVID-19 季度變化的典型特徵。

  • Full year sales were $1.8 billion, down 18% from 2023 and in line with our expectations.

    全年銷售額為 18 億美元,較 2023 年下降 18%,符合我們的預期。

  • Moving to oncology on slide 15, full year sales of $3.3 billion increased 12% year-over-year, reflecting our growing presence in this area of high unmet need, and we're proud to have treated over 80,000 patients to date across Trodelvy and our cell therapies.

    轉到第 15 頁的腫瘤學,全年銷售額為 33 億美元,同比增長 12%,反映了我們在這一尚未滿足的巨大需求領域的不斷增長,我們很自豪迄今為止已經通過 Trodelvy 和細胞療法治療了超過 80,000 名患者。

  • On slide 16, fourth quarter Trodelvy sales of $355 million increased 19% year-over-year and 7% sequentially with full year sales increasing 24% year-over-year to $1.3 billion.

    第 16 頁顯示,Trodelvy 第四季銷售額為 3.55 億美元,年增 19%,季增 7%,全年銷售額年增 24%,達到 13 億美元。

  • Year-over-year growth for both periods reflected higher demand in all regions, highlighting the important role of Trodelvy in metastatic breast cancers, including second-line metastatic triple-negative breast cancer, where it's a standard of care.

    兩個時期的同比增長反映了所有地區的需求增加,凸顯了 Trodelvy 在轉移性乳癌(包括二線轉移性三陰性乳癌)中的重要作用,它是該疾病的標準治療方法。

  • In particular, Trodelvy continues to maintain market leadership in the metastatic triple-negative breast cancer setting across both the US and Europe and is approved in 55 markets.

    特別是,Trodelvy 繼續保持美國和歐洲轉移性三陰性乳癌市場的領先地位,並在 55 個市場獲得批准。

  • Combined with ongoing adoption in the pretreated HR-positive/HER2-negative metastatic breast cancer setting, we are pleased to see continued growing demand for Trodelvy.

    結合在預處理的 HR 陽性/HER2 陰性轉移性乳癌環境中的持續應用,我們很高興看到對 Trodelvy 的需求持續成長。

  • Moving to cell therapy on slide 17, and on behalf of Cindy and the Kite team, full year sales of $2 billion and over 7,000 patients treated in 2024 demonstrate Kite's continued leadership in CAR T. As expected, the fourth quarter cell therapy sales of $488 million were flat on a sequential basis and up 5% year-over-year, reflecting the continued challenging competitive dynamics in the US and in Europe.

    轉到第 17 頁的細胞療法,代表 Cindy 和 Kite 團隊,全年銷售額 20 億美元,2024 年治療患者超過 7,000 名,證明了 Kite 在 CAR T 領域的持續領導地位。 正如預期的那樣,第四季度細胞療法銷售額為 4.88 億美元,環比持平,同比增長 5%,反映了美國和歐洲嚴峻的競爭。

  • These headwinds include a number of new cell therapy launches across indications both in the US and outside the US in addition to a slower-than-targeted uptake of cell therapy as a class.

    這些不利因素包括美國國內和國外推出了多種適用於不同適應症的新型細胞療法,以及細胞療法這一類別的吸收速度低於目標。

  • We expect continued competitive headwinds in 2025.

    我們預計 2025 年競爭仍將面臨阻力。

  • We are making progress on our goal to make cell therapies available to large integrated community oncology practices in the US.

    我們正在朝著讓美國大型綜合社區腫瘤診所能夠使用細胞療法的目標邁進。

  • This involves addressing some of the hurdles for these networks to begin CAR T treatment, including that CAR T sites often need to be accredited by the foundation for the accreditation of cellular therapy, or FACT, often enabling wider commercial reimbursement.

    這涉及解決這些網路開始 CAR-T 治療的一些障礙,包括 CAR-T 站點通常需要獲得細胞治療認證基金會 (FACT) 的認證,這通常能夠獲得更廣泛的商業報銷。

  • We are working with industry groups and other manufacturers to address barriers through policy reform and exploring accreditation with groups like FACT.

    我們正在與行業團體和其他製造商合作,透過政策改革解決障礙,並探索與 FACT 等團體的認證。

  • We look forward to sharing our progress with you in future quarters.

    我們期待在未來幾季與您分享我們的進展。

  • Wrapping up 2024, I'm proud of the positive impact of Gilead's compelling portfolio of medicines on millions of people around the world.

    2024 年即將結束,我為吉利德引人注目的藥物組合對全球數百萬人產生的正面影響感到自豪。

  • As we look to 2025, the commercialization teams are invigorated to extend the reach of our potentially transformative medicines to even more patients, and we remain focused on launch activities, including for the potential launch of lenacapavir for PrEP this summer.

    展望 2025 年,商業化團隊將竭盡全力將我們具有潛在變革性的藥物惠及更多患者,並且我們將繼續專注於發布活動,包括今年夏天可能推出 PrEP 的 lenacapavir。

  • 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。

  • Dietmar Berger - Chief Medical Officer

    Dietmar Berger - Chief Medical Officer

  • Thank you, Johanna, and good afternoon, everyone.

    謝謝你,喬安娜,大家下午好。

  • I'm now in my sixth week as Gilead's Chief Medical Officer, and I have been impressed with the outstanding talent we have across therapeutic areas here at Gilead and the depth of innovation across our 54 clinical programs.

    我擔任吉利德首席醫療官已有六週,吉利德在各個治療領域的傑出人才以及 54 個臨床項目的創新深度給我留下了深刻的印象。

  • I'm deeply committed to working alongside my colleagues to continue executing on these potentially life-changing medicines.

    我全心全意地致力於與我的同事們一起繼續發展這些可能改變生活的藥物。

  • Let me start on Slide 19 by recognizing our research and development teams for their incredible work on lenacapavir, a first-in-class capsid inhibitor that was recently recognized by Science as 2024's Breakthrough of the Year.

    首先,我要從第 19 張幻燈片開始,感謝我們的研發團隊在 lenacapavir 方面所做的出色工作。

  • To put this in context, Science's prior HIV breakthroughs included the discovery of HAART in 1996 and later, the discovery of HIV treatment as prevention in 2011.

    具體來說,科學界先前在愛滋病毒方面的突破包括 1996 年發現 HAART 以及後來在 2011 年發現愛滋病毒治療作為預防措施。

  • This achievement highlights the transformative potential of lenacapavir and Gilead's commitment to help end the HIV epidemic for everyone everywhere.

    這項成就凸顯了雷那帕韋的變革潛力和吉利德幫助世界各地所有人終結愛滋病流行的承諾。

  • Lenacapavir for prevention was granted the FDA's Breakthrough Therapy designation in October, and we subsequently completed our own drug application on December 19, suggesting a possible regulatory decision in the summer.

    用於預防的雷那卡韋於 10 月獲得了 FDA 的突破性療法認定,隨後我們於 12 月 19 日完成了自己的藥物申請,這意味著監管部門可能會在夏季做出決定。

  • As part of our commitment to global health equity, we have filed with the EMA and are taking part in the EU-Medicines for All initiative.

    作為我們對全球健康公平承諾的一部分,我們已向 EMA 提交申請並參與歐盟全民醫療計劃。

  • This collaboration combines EMA's scientific review capabilities and local expertise from regulatory agencies in low and lower-middle-income countries to bring medicines critical to public health to communities around the world.

    此次合作結合了 EMA 的科學審查能力以及來自低收入和中低收入國家監管機構的本地專業知識,將對公共健康至關重要的藥物帶給世界各地的社區。

  • This process could accelerate the review process for lenacapavir in up to 138 countries worldwide.

    這項進程可以加速全球多達138個國家對萊那帕韋的審查進程。

  • The marketing authorization and EU-M4all applications with the EMA will undergo parallel assessments under an accelerated review timeline, and we anticipate a European Commission regulatory decision in the second half of this year.

    行銷授權和 EMA 的 EU-M4all 申請將根據加速審查時間表進行平行評估,我們預計歐盟委員會將在今年下半年做出監管決定。

  • Lenacapavir's unique profile could similarly transform HIV treatment.

    雷那帕韋的獨特特性同樣可以改變愛滋病毒的治療。

  • On slide 20, I highlight that we are developing 7 potential new treatments using lenacapavir or lenacapavir prodrug-based combinations for new daily, weekly, monthly, quarterly and twice-yearly treatment options.

    在第 20 張投影片上,我強調我們正在開發 7 種潛在的新療法,使用以雷那卡韋或雷那卡韋前藥為基礎的組合,為每日、每週、每月、每季和每年兩次提供新的治療選擇。

  • In 2025, we expect to share an update from the Phase 2 WONDERS-1 trial, evaluating the combination of GS-1720 and GS-4182 as a once-weekly treatment regimen for virologically suppressed people with HIV and an update from our Phase 3 ARTISTRY-1 trial, evaluating once-daily bictegravir in combination with lenacapavir for virologically suppressed treatment-experienced people with HIV.

    2025 年,我們預計將分享第 2 階段 WONDERS-1 試驗的最新消息,該試驗評估了 GS-1720 和 GS-4182 的組合作為每週一次治療方案對病毒學抑制的 HIV 患者的療效,以及第 3 階段 ARTISTRY-1 試驗的最新消息,該試驗評估了每日比拉韋克的藥物對 HIV 的治療的最新消息,該試驗對醫學的研究

  • This medicine could serve as the first single-tablet regimen for the 6% to 8% of people with HIV on complex regimens or in other words, for people whose HIV cannot be adequately suppressed on single-tablet regimens available today.

    對於 6% 至 8% 接受複雜治療方案的愛滋病毒感染者,或者換句話說,對於那些目前單一藥片治療方案無法充分抑制愛滋病毒的患者,這種藥物可以作為首個單一藥片治療方案。

  • Moving to liver disease on Slide 21, the MHRA recently granted Livdelzi Marketing Authorization in the UK as a treatment for primary biliary cholangitis, or PBC, including related pruritus.

    轉到幻燈片 21 上的肝病,MHRA 最近授予 Livdelzi 在英國的營銷授權,用於治療原發性膽汁性膽管炎 (PBC),包括相關的瘙癢。

  • In December, we received a positive CHMP opinion for seladelpar, and we're excited to potentially bring the first and only PBC treatment shown to significantly reduce alkaline phosphatase, or ALP, and PBC-related itch to the rest of Europe.

    12 月,我們收到了 CHMP 對 seladelpar 的積極評價,我們很高興能將第一種也是唯一一種被證實能顯著降低鹼性磷酸酶 (ALP) 和 PBC 相關瘙癢的 PBC 治療方法帶到歐洲其他地區。

  • With that said, seladelpar's clinical development is far from complete.

    話雖如此,seladelpar 的臨床開發還遠遠沒有完成。

  • We continue to make progress on the confirmatory Phase 3b/4 AFFIRM trial designed to support a full FDA approval.

    我們繼續在旨在支持 FDA 全面批准的確認性 3b/4 期 AFFIRM 試驗方面取得進展。

  • Further, many PBC patients on ursodeoxycholic acid have ALP improvement but do not normalize ALP, which is increasingly appreciated as a treatment goal.

    此外,許多服用熊去氧膽酸的 PBC 患者的 ALP 有所改善,但 ALP 並沒有恢復正常,而這作為治療目標越來越受到重視。

  • Patients with a persistent elevation of ALP but whose ALP levels are not above the threshold of 1.67x the upper limit of normal have historically not been studied in clinical trials of new second-line agents.

    以往,ALP 持續升高但其水準未超過正常值上限 1.67 倍的患者未在新的二線藥物臨床試驗中進行研究。

  • We are enrolling these patients into our Phase 3 IDEAL trial with the hopes of demonstrating seladelpar's capacity to normalize biochemical markers of disease activity in this previously understudied patient population with incomplete control of ALP levels.

    我們正在將這些患者納入我們的 3 期 IDEAL 試驗,希望證明 seladelpar 有能力使這一先前研究不足且 ALP 水平控制不完全的患者群體的疾病活動生化標誌物正常化。

  • Moving to oncology on Slide 22, we remain focused on clinical execution of our 8 ongoing Phase 3 programs for Trodelvy and domvanalimab across 5 tumor types.

    轉到幻燈片 22 上的腫瘤學,我們仍然專注於針對 5 種腫瘤類型的 Trodelvy 和 domvanalimab 的 8 個正在進行的 3 期項目的臨床執行。

  • This year, we anticipate providing updates from the Phase 3 ASCENT-03 trial, evaluating Trodelvy in first-line metastatic, triple-negative breast cancer patients who are not candidates for anti-PD-1 therapy in the first half of 2025; and from the Phase 3 ASCENT-04 trial evaluating Trodelvy in combination with Merck's pembrolizumab in first-line, PD-L1-positive, metastatic triple-negative breast cancer patients in the second half of 2025.

    今年,我們預計將提供 3 期 ASCENT-03 試驗的最新消息,該試驗將在 2025 年上半年評估 Trodelvy 對不適合接受抗 PD-1 治療的一線轉移性三陰性乳癌患者的療效;以及來自 3 期 ASCENT-04 試驗,該試驗評估 Trodelvy 與默克公司的 pembrolizumab 聯合用於 2025 年下半年一線、PD-L1 陽性、轉移性三陰性乳癌患者的治療效果。

  • These trials could provide Trodelvy the opportunity to advance into the first line setting for metastatic triple-negative breast cancer as early as 2026.

    這些試驗可以為 Trodelvy 提供機會,最早在 2026 年進入轉移性三陰性乳癌第一線治療領域。

  • Additionally, we have the Phase 3 ASCENT-07 trial in chemotherapy-naive, hormone receptor-positive, HER2-negative metastatic breast cancer that completed enrollment in August of last year.

    此外,我們還有一項針對未接受化療、荷爾蒙受體陽性、HER2 陰性轉移性乳癌的 3 期 ASCENT-07 試驗,該試驗於去年 8 月完成招募。

  • In lung cancer, Trodelvy continues to be evaluated in combination with pembro in first-line PD-L1-high metastatic non-small cell lung cancer in the Phase 3 EVOKE-03 study.

    在肺癌領域,Trodelvy 繼續在第 3 期 EVOKE-03 研究中與 pembro 聯合用於一線 PD-L1 高轉移性非小細胞肺癌治療。

  • Further, FDA has granted Trodelvy Breakthrough Therapy designation for extensive-stage small cell lung cancer patients whose disease progressed on or after platinum-based chemotherapy.

    此外,FDA 也授予 Trodelvy 突破性療法認定,適用於在鉑類化療期間或之後病情出現進展的廣泛期小細胞肺癌患者。

  • Unfortunately, most small cell lung cancer cases are diagnosed in extensive-stage given the aggressive nature of the disease.

    不幸的是,由於小細胞肺癌的侵襲性,大多數小細胞肺癌病例都是在廣泛期才被診斷出來的。

  • And median overall survival typically is between 8 and 12 months.

    中位總存活期通常為 8 至 12 個月。

  • In the small cell lung cancer cohort of the Phase 2 TROPiCS-03 trial shared at World Lung last year, Trodelvy demonstrated a promising 13.6-month median overall survival.

    在去年世界肺臟大會上分享的 2 期 TROPiCS-03 試驗的小細胞肺癌隊列中,Trodelvy 展示了令人鼓舞的 13.6 個月中位總存活期。

  • We plan to initiate the Phase 3 EVOKE SCLC trial in the first half of 2025.

    我們計劃在 2025 年上半年啟動第 3 期 EVOKE SCLC 試驗。

  • Moving to slide 23, and on behalf of Cindy and the Kite team, we shared several exciting updates during the ASH Congress in December.

    轉到第 23 張投影片,我們代表 Cindy 和 Kite 團隊在 12 月的 ASH 大會上分享了幾個令人興奮的更新。

  • In particular, we presented preliminary results from the registrational Phase 2 iMMagine-1 trial, evaluating anito-cel in fourth line or later relapsed or refractory multiple myeloma, which we believe demonstrated competitive efficacy and safety data.

    具體來說,我們展示了註冊第 2 階段 iMMagine-1 試驗的初步結果,該試驗評估了 anito-cel 在四線或更高版本復發或難治性多發性骨髓瘤中的應用,我們相信該試驗具有競爭力的療效和安全性數據。

  • Notably, in 86 efficacy-evaluable patients with a median follow-up of 9.5 months, anito-cel demonstrated an overall response rate of 97% with complete response of 62%, and we expect that the responses will likely deepen over time.

    值得注意的是,在 86 名療效可評估患者中,中位追蹤期為 9.5 個月,anito-cel 的整體反應率為 97%,完全反應率為 62%,我們預期反應可能會隨著時間的推移而加深。

  • Minimal residual disease negativity was achieved in 93% of evaluable patients.

    93% 的可評估患者實現了微小殘留疾病陰性。

  • Anito-cel's safety profile was generally manageable, and as of the ASH presentation, no delayed neurotoxicities have been observed across the more than 150 patients dosed in anito-cel trials, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barre syndrome.

    Anito-cel 的安全性總體上是可控的,截至 ASH 報告,在參加 anito-cel 試驗的 150 多名患者中未觀察到延遲性神經毒性,包括帕金森氏症、腦神經麻痺和格林巴利症候群。

  • We remain confident in the potential for anito-cel to deliver a best-in-class profile, supported by the efficacy and safety data seen to date as well as Kite's globally leading manufacturing capabilities and continue to target 2026 for a commercial launch.

    我們仍然相信 anito-cel 有潛力提供一流的產品,這有迄今為止的功效和安全性數據以及 Kite 全球領先的製造能力所支持,我們繼續以 2026 年實現商業化上市為目標。

  • We expect to provide further data from iMMagine-1 during the course of 2025.

    我們預計將在 2025 年期間提供更多來自 iMMagine-1 的數據。

  • As we announced in December, the Phase 3 iMMagine-3 trial in second-to-fourth-line relapsed or refractory multiple myeloma has dosed its first patients, and we look forward to providing an update on anito-cel's progress in due course.

    正如我們在 12 月宣布的那樣,針對二至四線復發或難治性多發性骨髓瘤的 3 期 iMMagine-3 試驗已經對首批患者進行了給藥,我們期待在適當的時候提供有關 anito-cel 進展的最新信息。

  • Additionally, we shared updates on Yescarta and Tecartus, which included follow-up from the ZUMA-5 trial evaluating Yescarta in relapsed or refractory non-Hodgkin's lymphoma, demonstrating a 69% overall survival rate at 5 years of follow-up.

    此外,我們也分享了 Yescarta 和 Tecartus 的最新進展,其中包括 ZUMA-5 試驗的後續研究,該試驗評估了 Yescarta 在治療復發或難治性非何杰金氏淋巴瘤中的療效,結果顯示,5 年追蹤中的整體存活率為 69%。

  • Yescarta and Tecartus continue to demonstrate durable responses and long-term overall survival that support their curative potential.

    Yescarta 和 Tecartus 繼續表現出持久的反應和長期整體存活率,支持其治療潛力。

  • We are also pleased to announce that Kite has now filed an IND application with FDA to evaluate KITE-363 in autoimmune conditions.

    我們也很高興地宣布,Kite 現在已向 FDA 提交了 IND 申請,以評估 KITE-363 在自體免疫疾病中的作用。

  • As a reminder, KITE-363 is a bicistronic CAR T product that targets both CD19 and CD20, and each CAR has its own distinct co-stimulatory domain.

    提醒一下,KITE-363 是雙順反子 CAR T 產品,針對 CD19 和 CD20,每個 CAR 都有自己獨特的共刺激結構域。

  • We believe cell therapy has great potential in meeting the substantial unmet needs of this large patient population, and we are excited to begin our clinical work.

    我們相信細胞療法在滿足這一龐大患者群體的大量未滿足需求方面具有巨大潛力,我們很高興開始我們的臨床工作。

  • We will share more information when available.

    如有更多信息,我們將分享。

  • Joining Gilead, I look forward to working with Flavius Martin, our Executive Vice President of Research, on some of the most exciting science in the biopharma industry.

    加入吉利德後,我期待與我們的研究執行副總裁 Flavius Martin 一起研究生物製藥行業一些最令人興奮的科學研究。

  • On slide 24, you can see some of the early-stage targets Gilead is working on amongst an extensive pipeline of over 100 innovative pre-IND and clinical-stage programs.

    在投影片 24 上,您可以看到吉利德正在研究的一些早期目標,其中包括 100 多個創新的 IND 前和臨床階段項目。

  • Finally, on slide 25, we have several interesting milestones this year, including regulatory decisions on lenacapavir and seladelpar, Phase 3 updates for our bictegravir and lenacapavir combination as well as Trodelvy, and Phase 2 updates for anito-cel in fourth line plus multiple myeloma and for our weekly oral HIV treatment.

    最後,在第 25 張幻燈片上,我們今年有幾個有趣的里程碑,包括對 lenacapavir 和 seladelpar 的監管決定、bictegravir 和 lenacapavir 組合以及 Trodelvy 的 3 期更新,以及第四線加多發性骨髓瘤的 anito-cel 和我們每週口服 HIV 治療的 2 期更新。

  • We are also initiating new Phase 3 trials, including in extensive-stage small cell lung cancer and across our long-acting HIV prevention programs, that should bring forth new exciting updates in the years to come.

    我們也正在啟動新的 3 期試驗,包括廣泛期小細胞肺癌和長效愛滋病毒預防計劃,這些試驗將在未來幾年帶來令人興奮的新成果。

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

    現在我將電話交給安迪。

  • Andrew Dickinson - Chief Financial Officer

    Andrew Dickinson - Chief Financial Officer

  • Thank you, Dietmar, and good afternoon, everyone.

    謝謝你,迪特馬爾,大家下午好。

  • Starting on slide 27, we closed the year with total product sales of $28.6 billion, up 6% from 2023 and well above our $27.8 billion to $28.1 billion guidance range due to stronger-than-expected contributions from HIV.

    從第 27 張投影片開始,我們以 286 億美元的總產品銷售額結束了這一財年,比 2023 年增長 6%,遠高於我們 278 億美元至 281 億美元的指導範圍,這得益於愛滋病毒的貢獻強於預期。

  • For the full year, total product sales, excluding Veklury, grew more than $2 billion or 8% from 2023, exceeding our 5% to 6% guidance range and driven by growth in HIV, oncology and liver.

    全年而言,不包括 Veklury 在內的總產品銷售額較 2023 年增長超過 20 億美元或 8%,超過了我們 5% 至 6% 的指導範圍,主要得益於愛滋病毒、腫瘤學和肝臟領域的增長。

  • HIV increased 8% or $1.4 billion to $19.6 billion driven by Biktarvy, which grew 13% from 2023.

    在 Biktarvy 的推動下,愛滋病毒銷售額成長了 8%,即 14 億美元,達到 196 億美元,比 2023 年成長了 13%。

  • Oncology increased 12% to $3.3 billion primarily driven by growth in Trodelvy and with a more modest growth contribution from cell therapy.

    腫瘤學銷售額成長 12%,達到 33 億美元,主要得益於 Trodelvy 的成長,以及細胞療法較溫和的成長貢獻。

  • And liver increased 9% to $3 billion with growth across our portfolio of liver treatments.

    隨著我們肝臟治療產品組合的成長,肝臟治療銷售額成長了 9%,達到 30 億美元。

  • Full year Veklury revenue of $1.8 billion was right in line with our expectations and declined 18% from 2023, consistent with pandemic and hospitalization trends.

    Veklury 全年營收為 18 億美元,符合我們的預期,較 2023 年下降 18%,與疫情和住院趨勢一致。

  • Moving to slide 28, our full year non-GAAP results highlight consistent expense discipline in 2024: R&D of $5.7 billion was flat with 2023.

    轉到第 28 張投影片,我們的全年非 GAAP 業績凸顯了 2024 年一致的費用紀律:57 億美元的研發費用與 2023 年持平。

  • IPR&D of $4.7 billion included $3.9 billion associated with the CymaBay acquisition in the first quarter in addition to our normal course IP R&D expenses.

    47 億美元的智慧財產權與開發費用包括第一季收購 CymaBay 相關的 39 億美元以及我們正常的智慧財產權研發費用。

  • And SG&A of $5.9 billion was down 3% from 2023.

    銷售、一般及行政開支為 59 億美元,較 2023 年下降 3%。

  • Overall, 2024 operating income was $8.5 billion, ahead of our guidance range of $8 billion to $8.3 billion.

    整體而言,2024 年營業收入為 85 億美元,高於我們預期的 80 億至 83 億美元範圍。

  • Note, full year operating margin of 30% reflects the first quarter 2024 acquisition of CymaBay.

    請注意,全年營業利潤率 30% 反映了 2024 年第一季對 CymaBay 的收購。

  • Excluding this transaction, our operating margin would have been 43% for the full year.

    如果不計這筆交易,我們全年的營業利益率將達到43%。

  • Similarly, non-GAAP EPS of $4.62 reflects the $3.14 per share impact of this transaction.

    同樣,非 GAAP 每股收益 4.62 美元反映了這筆交易對每股 3.14 美元的影響。

  • Excluding this, our non-GAAP EPS would have been $7.75, up 15% from the $6.72 reported in 2023.

    除此之外,我們的非 GAAP 每股收益將為 7.75 美元,比 2023 年報告的 6.72 美元增加 15%。

  • Moving to our fourth quarter results, starting on slide 29.

    從第 29 頁開始介紹我們的第四季業績。

  • Total product sales, excluding Veklury, were $7.2 billion, up 13% from the same quarter in 2023.

    不包括 Veklury 在內的總產品銷售額為 72 億美元,較 2023 年同期成長 13%。

  • Including Veklury, total product sales of $7.5 billion were up 7% from 2023 with higher base business growth, partially offset by a decline in Veklury sales.

    包括 Veklury 在內,總產品銷售額為 75 億美元,較 2023 年增長 7%,基礎業務增長較高,但 Veklury 銷售額的下降部分抵消了這一影響。

  • On Slide 30, you can see that on a non-GAAP basis, product gross margin was approximately 87% compared to 86% in the same period in 2023.

    在投影片 30 上,您可以看到,以非 GAAP 計算,產品毛利率約為 87%,而 2023 年同期為 86%。

  • R&D expenses were $1.6 billion, up from $1.5 billion in the same period in 2023, reflecting incremental investments in clinical activities across our portfolio.

    研發費用為 16 億美元,高於 2023 年同期的 15 億美元,反映了我們整個投資組合對臨床活動的投資增加。

  • Acquired IPR&D was negative $11 million, reflecting expenses related to the Terray and Tubulis collaborations, offset by a favorable adjustment related to the CymaBay acquisition.

    收購的 IPR&D 為負 1,100 萬美元,反映了與 Terray 和 Tubulis 合作相關的費用,但與 CymaBay 收購相關的有利調整抵消了這一影響。

  • Note that the acquisition of certain rights from LEO's STAT6 program will be reflected in our first quarter 2025 results.

    請注意,從 LEO 的 STAT6 計劃獲得的某些權利將反映在我們的 2025 年第一季的業績中。

  • SG&A was $1.9 billion, up 16% from the same period in the prior year, partially driven by a litigation accrual for a potential settlement with the US.

    銷售、一般及行政開支為 19 億美元,較上年同期增加 16%,部分原因是與美國可能達成的和解的訴訟費用增加。

  • Attorney's Office for the Southern District of New York relating to our promotional speaker programs for HIV medicines.

    紐約南區檢察官辦公室有關我們愛滋病藥物促銷演講計畫的訴訟。

  • Additionally, there was higher sales and marketing spending, including launch preparation activities for lenacapavir for HIV prevention as well as for Livdelzi for PBC.

    此外,銷售和行銷支出也有所增加,包括用於預防愛滋病毒的 lenacapavir 以及用於治療原發性膽管炎的 Livdelzi 的上市準備活動。

  • Operating margin was 41%, up from 39% in the fourth quarter of 2023.

    營業利益率為 41%,高於 2023 年第四季的 39%。

  • And the effective tax rate in the fourth quarter was 19.2% compared to 17.1% in the same period in 2023 primarily due to prior year settlements with tax authorities.

    第四季的有效稅率為 19.2%,而 2023 年同期為 17.1%,這主要是由於前幾年與稅務機關的結算。

  • Overall, our non-GAAP diluted earnings per share was $1.90 in the fourth quarter compared to $1.72 in the fourth quarter of 2023.

    總體而言,我們第四季的非 GAAP 稀釋每股收益為 1.90 美元,而 2023 年第四季為 1.72 美元。

  • Moving to slide 31 and before I get into guidance, I want to remind you of certain factors that are impacting our revenue expectations for 2025 and masking the underlying strength of our business.

    轉到第 31 張投影片,在我開始提供指導之前,我想提醒您一些影響我們 2025 年收入預期並掩蓋我們業務潛在實力的因素。

  • As previously discussed, Medicare Part D reform is expected to impact our revenue by approximately $1.1 billion, including $900 million in HIV.

    如前所述,醫療保險 D 部分改革預計將影響我們的收入約 11 億美元,其中包括 9 億美元的愛滋病毒收入。

  • For this year only, this transition masked the robust demand-led volume growth that we have seen over the last several years and that we expect to continue through 2025 and into 2026 and beyond.

    僅就今年而言,這種轉變掩蓋了我們在過去幾年看到的強勁的需求主導型銷售成長,我們預計這種成長將持續到 2025 年、2026 年及以後。

  • Across our entire business, this represents about a 4% impact on revenue growth in 2025.

    就我們整個業務而言,這將對 2025 年的收入成長產生約 4% 的影響。

  • Second, you can see that our Veklury expectations are about $400 million lower in 2025 versus 2024, representing an additional growth headwind of roughly 1%.

    其次,您可以看到,我們對 2025 年的 Veklury 預期比 2024 年低約 4 億美元,這意味著額外的成長阻力約為 1%。

  • And finally, our guidance reflects a $250 million headwind from FX given the US dollar has strengthened against major foreign currencies, offsetting another approximately 1% of expected growth.

    最後,由於美元兌主要外幣走強,我們的預期反映了外匯帶來的 2.5 億美元逆風,抵銷了預期成長的約 1%。

  • You can see that excluding the IRA FX and Veklury headwinds, our guidance today would have been for total product revenue growth of approximately 5% to 6%.

    您可以看到,除去 IRA FX 和 Veklury 的不利因素,我們今天的預期是總產品收入成長約 5% 至 6%。

  • On slide 32, you can see our guidance for 2025, which assumes a generally stable macro environment, including FX at current rates.

    在第 32 張投影片上,您可以看到我們對 2025 年的指導,其中假設宏觀環境總體穩定,包括當前匯率的外匯。

  • For the full year 2025, we expect total product sales of approximately $28.2 billion to $28.6 billion.

    就 2025 年全年而言,我們預計總產品銷售額約為 282 億美元至 286 億美元。

  • We expect total product sales, excluding Veklury, of approximately $26.8 billion to $27.2 billion.

    我們預計不包括 Veklury 在內的總產品銷售額約為 268 億至 272 億美元。

  • We expect Veklury sales of approximately $1.4 billion, although, as always, there's greater variability in this estimate.

    我們預期 Veklury 的銷售額約為 14 億美元,不過和往常一樣,這個估值的波動性較大。

  • Similar to last year, we do not expect to update our Veklury guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infections.

    與去年類似,如果 COVID-19 感染趨勢不明顯,我們預計直到第三季財報電話會議之前都不會更新我們的 Veklury 指引。

  • Moving to the rest of the P&L and on a non-GAAP basis: We expect product gross margin to range between 85% and 86%.

    轉向損益表的其餘部分並基於非 GAAP 基礎:我們預計產品毛利率在 85% 至 86% 之間。

  • We expect R&D to be roughly flat from 2024, highlighting that we believe we now have the appropriate scale of investment to support our diverse pipeline.

    我們預計從 2024 年起研發支出將基本持平,這表明我們相信現在我們已經擁有適當的投資規模來支持我們多樣化的產品線。

  • We expect acquired IPR&D to be approximately $400 million and includes roughly $250 million associated with the acquisition of LEO Pharma’s STAT6 program announced in January.

    我們預計收購的 IPR&D 價值約為 4 億美元,其中包括 1 月宣布的收購 LEO Pharma 的 STAT6 項目相關的約 2.5 億美元。

  • The remaining $150 million we are guiding to today reflects known commitments and expected milestone payments.

    我們今天指導的剩餘 1.5 億美元反映了已知的承諾和預期的里程碑付款。

  • Consistent with our approach over the last 2 years, we will highlight incremental acquired IPR&D expenses as we announce new transactions and update our guidance each quarter.

    與我們過去兩年的做法一致,我們將在宣布新交易和更新每季的指引時重點介紹增量收購的智慧財產權和開發費用。

  • And finally, we expect SG&A to decline by a high single-digit percentage compared to 2024.

    最後,我們預期銷售、一般及行政開支將與 2024 年相比下降高個位數百分比。

  • Excluding the litigation accrual in 2024, our SG&A would decline a mid-single-digit percentage in 2025, reflecting our ongoing commitment to operating expense discipline.

    除去 2024 年的訴訟應計費用,我們的銷售、一般及行政費用將在 2025 年下降中等個位數百分比,這反映了我們對營運費用紀律的持續承諾。

  • As a result, we expect our operating income for 2025 to be between $12.7 billion and $13.2 billion.

    因此,我們預計 2025 年的營業收入將在 127 億美元至 132 億美元之間。

  • We expect our effective tax rate to be approximately 19%.

    我們預計我們的有效稅率約為19%。

  • And finally, we expect our non-GAAP diluted EPS to be between $7.70 and $8.10 for the full year and GAAP diluted EPS to be between $5.95 and $6.35. As a reminder, for the first quarter of 2025, we expect HIV revenue to decline in the mid-teen percentage range compared to the very strong revenue delivered in the fourth quarter due to both normal inventory drawn-down in the first quarter, coupled with the IRA headwind.

    最後,我們預計全年非 GAAP 稀釋每股收益在 7.70 美元至 8.10 美元之間,GAAP 稀釋每股收益在 5.95 美元至 6.35 美元之間。提醒一下,對於 2025 年第一季度,我們預計 HIV 收入將下降百分之十幾左右,而第四季度的收入非常強勁,原因是第一季正常庫存減少,再加上 IRA 逆風。

  • Moving to capital allocation on slide 33.

    前往第 33 張投影片上的資本配置。

  • Our priorities have not changed.

    我們的優先事項沒有改變。

  • In 2024, we returned $5.1 billion to shareholders.

    2024年,我們向股東返還了51億美元。

  • This included $3.9 billion in dividend payments and $1.2 billion in share repurchases.

    其中包括 39 億美元的股息支付和 12 億美元的股票回購。

  • For 2025, we announced today a 2.6% increase in our quarterly cash dividend to $0.79 per share, and we remain committed to growing our dividend over time.

    針對 2025 年,我們今天宣布季度現金股息將增加 2.6% 至每股 0.79 美元,我們仍致力於隨著時間的推移增加股息。

  • You can also expect to see continued investments in our business both internally and externally through select partnerships and business development transactions.

    您還可以期待看到我們透過精選的合作夥伴關係和業務發展交易對內部和外部業務的持續投資。

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

    最後,我們將繼續利用股票回購來抵銷股權稀釋以及機會性地進行額外回購。

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

    現在,我將邀請 Rebekah 開始問答環節。

  • Operator

    Operator

  • (Operator Instructions) Geoff Meacham, Citigroup.

    (操作員指示)花旗集團的 Geoff Meacham。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • In HIV, I know you guys are looking at len and PrEP to be a big growth driver over time.

    在 HIV 領域,我知道你們正在考慮將 len 和 PrEP 視為未來巨大的成長動力。

  • But I wanted to ask about the HIV treatment setting.

    但我想詢問有關愛滋病治療的情況。

  • I guess the question is, do you guys view all the different len treatment options that you detail on slide 20 as eventually replacing Biktarvy?

    我想問題是,你們是否認為第 20 張投影片上詳述的所有不同的鏡片治療方案最終都可以取代 Biktarvy?

  • I wasn't sure how you're thinking about what the best approach is for life cycle management and even prior to the Biktarvy LOE.

    我不確定您如何思考生命週期管理的最佳方法,甚至在 Biktarvy LOE 之前。

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Geoff, let me just welcome everybody to the call again.

    傑夫,我再次歡迎大家參加電話會議。

  • I'll just turn it over to Johanna.

    我就把它交給喬安娜吧。

  • And I'll just ask the speakers as they respond to questions to just introduce themselves.

    我只是請發言者在回答問題時自我介紹。

  • So Johanna, over to you.

    那麼 Johanna,交給你了。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Great.

    偉大的。

  • Johanna.

    約翰娜。

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Well, you don't have to do it on that.

    嗯,你不必這麼做。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Kidding.

    開玩笑。

  • Geoff, thanks for the question.

    傑夫,謝謝你的提問。

  • Listen, absolutely.

    聽著,絕對是如此。

  • Our strategy is definitely an opportunity to just make sure that we meet the patient needs.

    我們的策略無疑是一個機會,以確保我們能夠滿足患者的需求。

  • And that is really now that Biktarvy has set the standard of care for HIV treatment.

    如今,Biktarvy 已真正為 HIV 治療樹立了標準。

  • We believe that the only thing that's left is looking at long-acting orals or long-acting injectables.

    我們相信剩下的唯一選擇就是研究長效口服藥或長效注射藥。

  • So we will have an opportunity as we think about the big len daily oral to a weekly -- actually, 2 weekly orals and then potentially even a little bit longer term with the 6-month players or whatnot to have an opportunity to look at the marketplace, and it automatically will erode some of the Biktarvy shares, right?

    因此,當我們考慮從每日口服大劑量到每週口服大劑量——實際上是 2 次每週口服大劑量,然後可能與 6 個月的參與者或諸如此類的更長期的參與者一起考慮時,我們將有機會觀察市場,它會自動侵蝕一些 Biktarvy 股份,對嗎?

  • As you think about a share of over 50% as the market leader, there will be opportunities for us to think about as a total Gilead portfolio well prior to the LOE in late 2033 of Biktarvy.

    當您考慮作為市場領導者佔有超過 50% 的份額時,我們將有機會在 2033 年底 Biktarvy 的 LOE 之前考慮吉利德的整體投資組合。

  • So there's a lot of optionality here as we think about what's to come, and there will be opportunities.

    所以當我們思考未來會發生什麼時,這裡有很多可選性,並且會有很多機會。

  • As long as it -- for us, it hits the standard of care that Biktarvy is set, plus brings optionality for patients with the long-acting administration.

    對我們來說,只要它達到了 Biktarvy 設定的護理標準,並且為長效給藥的患者帶來了可選性。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    摩根士丹利的特倫斯弗林 (Terence Flynn)。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Just 2-part on guidance.

    僅提供兩部分指導。

  • Just wanted to understand what is included, if anything, at all, for len for PrEP in the '25 revenue guide.

    只是想了解 '25 收入指南中 PrEP 的 len 是否包含任何內容。

  • And then it's great to see the margin expansion coming through again in '25 here.

    很高興看到利潤率在 25 年再次擴大。

  • And based on your comments, Andy, I'm assuming we should assume that this is kind of the steady-state level as we think about the forward into '26 as well but just wanted to check there.

    並且根據您的評論,安迪,我假設我們應該假設這是一種穩定狀態水平,因為我們也在考慮進入 26 年,但只是想檢查一下。

  • Andrew Dickinson - Chief Financial Officer

    Andrew Dickinson - Chief Financial Officer

  • Yes.

    是的。

  • Terence, it's Andy.

    特倫斯,我是安迪。

  • Thanks for the question.

    謝謝你的提問。

  • Look, lenacapavir, we're assuming a launch midyear.

    你看,利那帕韋,我們預計將於年中推出。

  • As we've said -- Johanna said consistently that we'll -- we'd like to have meaningful access, and access will build over time.

    正如我們所說的那樣 - 喬安娜一直說我們會 - 我們希望擁有有意義的訪問權限,並且訪問權限將隨著時間的推移而建立。

  • Obviously, at launch, you're working on adding to your access as quickly as possible.

    顯然,在發佈時,您正在努力盡快增加您的存取權限。

  • So I think after 6 months, we expect to have 75% access in the US and well north of that after 9 months and then a year.

    因此我認為,6 個月後,我們預計在美國的覆蓋率將達到 75%,9 個月和 1 年後,覆蓋率將遠遠超過這個數字。

  • But we are assuming a launch in the middle of the year.

    但我們預計將於今年年中推出。

  • So that -- but beyond that, I don't think there's much that we can say at this point in time.

    所以——但除此之外,我認為目前我們還不能說太多。

  • In terms of the expenses, you're absolutely right.

    就費用而言,你完全正確。

  • I mean we saw very strong expense control in 2024, despite -- I will also highlight, when you look at '24, there were a couple of unexpected items at the beginning of the year that actually increased our expenses.

    我的意思是,我們在 2024 年看到了非常強大的費用控制,儘管 - 我還要強調的是,當你看 24 年時,年初有幾個意外的項目實際上增加了我們的費用。

  • One of them is the litigation reserve that I highlighted in our prepared remarks that you saw in the fourth quarter.

    其中之一就是我在第四季的準備好的評論中強調的訴訟儲備。

  • The second, of course, are all the operating expenses for -- related to the Livdelzi acquisition that we absorbed throughout the year.

    第二當然是與 Livdelzi 收購相關的所有營運費用,我們全年都吸收了這些費用。

  • So even with that, you saw incredibly strong expense control throughout the year, and you see in our guidance that we expect to carry that forward in '25.

    因此,即使如此,您仍會看到全年費用控制都非常強勁,並且您可以從我們的指導中看到,我們預計在 25 年將繼續保持這種狀態。

  • So the last thing I'll say to your question is that we have said, we are targeting -- holding our expenses relatively flat for the foreseeable future and letting the leverage in our model drop to the bottom line, and that has not changed.

    所以,對於你的問題,我要說的最後一件事是,我們已經說過,我們的目標是——在可預見的未來保持我們的支出相對平穩,並讓我們模型中的槓桿率降至底線,這一點沒有改變。

  • We, of course, will provide more specific guidance on what that means for '26 and '27 when we get there.

    當然,當我們到達那裡時,我們將提供更具體的指導,說明這對'26和'27意味著什麼。

  • But it's a great start to the year and look forward to updating you as we progress.

    但這是今年的一個好開端,我們期待隨著進展向您報告最新情況。

  • Operator

    Operator

  • Tim Anderson, Bank of America.

    美國銀行的蒂姆·安德森。

  • Timothy Anderson - Analyst

    Timothy Anderson - Analyst

  • Lena, catheter and prep, so as we approach launch, concerns sometimes start to build, whether consensus could be too high relative to what the product could actually deliver in their initial few quarters after launch.

    莉娜 (Lena)、導管和準備工作,因此,當我們接近發佈時,有時會開始產生擔憂,即相對於產品在發布後的最初幾個季度內實際能夠實現的效果而言,共識是否會過高。

  • So in as much as you've looked at consensus, any comment on what you see?

    那麼,就您所看到的共識而言,您有什麼評論嗎?

  • Or perhaps you can just refresh us on the ramp dynamics when you did consider -- I know you just talked about access as one of those?

    或者也許您可以在考慮坡道動態時向我們重新介紹一下——我知道您剛才談到了通道就是其中之一?

  • And will this be a fast-, slow- or medium-paced launch?

    這次發表會將是快速、慢速還是中速的?

  • Any benchmarks for similar launches you'd like to point us to?

    您想向我們指出任何類似發布的基準嗎?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure.

    當然。

  • It's Johanna.

    是喬安娜。

  • I'll take that question, Tim.

    我來回答這個問題,提姆。

  • So as you know, we're very excited about the potential launch of lenacapavir this summer.

    如您所知,我們對今年夏天可能推出的 lenacapavir 感到非常興奮。

  • It's -- we don't give product-specific guidance, so I can't help you there.

    這是—我們不提供特定產品的指導,所以我無法幫助您。

  • What I can tell you is, in line with what Andy was saying about access, we do think access will ramp up.

    我可以告訴你的是,根據安迪所說的關於訪問權的說法,我們確實認為訪問權將會增加。

  • But it doesn't mean there won't be access until 6 months, right?

    但這並不意味著 6 個月內都無法訪問,對嗎?

  • Access will play out over the next few months of a launch.

    Access 將在接下來的幾個月內推出。

  • We're assuming about 75% or so access by 6 months, maybe about 90% by 12 months.

    我們預計 6 個月內訪問率將達到約 75%,12 個月內訪問率將達到約 90%。

  • We also think the administration, because this is an injectable, it's going to have to go through a specialty pharmacy or a buy-and-bill model.

    我們還認為,由於這是一種注射劑,因此管理必須透過專科藥房或購買帳單模式。

  • So that might just take a little bit of time in the first early months to make sure we ramp up for that administration.

    因此,在最初的幾個月裡,我們可能需要一點時間來確保我們為政府做好準備。

  • But we feel incredibly confident that lenacapavir is going to have an impact in our communities in 2025, and obviously, even more meaningful in '26 and beyond.

    但我們非常有信心,萊那帕韋將在 2025 年對我們的社區產生影響,並且顯然在 2026 年及以後產生更大的影響。

  • Operator

    Operator

  • Umer Raffat, Evercore ISI.

    Umer Raffat,Evercore ISI。

  • Umer Raffat - Analyst

    Umer Raffat - Analyst

  • Congratulations to Dietmar on joining.

    祝賀 Dietmar 的加入。

  • I wanted to focus very briefly on some of the anito-cel data you guys have shared.

    我想簡單介紹一下你們分享的一些 anito-cel 資料。

  • Obviously, a ton of very good color on the non-ICANs side.

    顯然,非 ICAN 方面有很多非常好的顏色。

  • I thought I would focus for a quick second on ICANS, more specifically, the 9 cases of ICAMs that happened in the iMMagine-1 trial.

    我想快速關註一下 ICANS,更具體地說,是 iMMagine-1 試驗中發生的 9 例 ICAM 病例。

  • And my question is, how many of those 9 cases had -- of ICANs had tremors, bradykinesia or any other motor dysfunction?

    我的問題是,在這 9 例 ICAN 病例中,有多少人出現震顫、運動遲緩或任何其他運動功能障礙?

  • And did any of the cases happen more than a couple of weeks out after the administration?

    這些案件是否發生在政府上任幾週後?

  • Cindy Perettie - Executive Vice President of Kite

    Cindy Perettie - Executive Vice President of Kite

  • Thanks, Umer.

    謝謝,烏默爾。

  • This is Cindy Perettie for the question.

    我是 Cindy Perettie,負責回答這個問題。

  • I'm not going to be able to answer probably at the level of detail you're looking for, for each one of those ICAMs that I know we can come back with you.

    對於每個 ICAM,我可能無法按照您所尋求的細節進行回答,但我知道我們可以為您提供答案。

  • But we did not see cases of tremors in those patients, and I can come back on the other two.

    但我們並沒有看到那些病人出現震顫的情況,我可以再回過頭來談談另外兩名病人。

  • Operator

    Operator

  • Michael Yee, Jefferies.

    傑富瑞 (Jefferies) 的麥可餘 (Michael Yee)。

  • Michael Yee - Analyst

    Michael Yee - Analyst

  • Looking ahead to the approval of len PrEP, can you just comment about your recent interactions with the FDA and the perspective of the FDA and HHS with the incoming administration with the US and that there should be no issues with a fast approval?

    展望 len PrEP 的批准,您能否評論一下您最近與 FDA 的互動以及 FDA 和 HHS 對美國新政府的看法,並說快速批准應該不會有問題?

  • And simultaneously, in Europe, that has never really gained significant revenue.

    同時,在歐洲,這項措施從未真正帶來可觀的收入。

  • So you highlight that as an approval?

    所以你強調這是你認可嗎?

  • And do you somehow see that reimbursement is going to be different there?

    您是否認為那裡的報銷方式會有所不同?

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • I'll just start and hand it over to either Johanna or Dietmar.

    我先開始,然後把它交給 Johanna 或 Dietmar。

  • Thanks, Michael, for the question.

    謝謝邁克爾提出這個問題。

  • Everything is on track for the lenacapavir for PrEP interactions with the agency and HHS.

    用於 PrEP 的 lenacapavir 與該機構和 HHS 的互動一切進展順利。

  • So we're continuing all preparation accordingly and getting ready for the approval this summer, as we discussed before.

    因此,正如我們之前討論的那樣,我們正在繼續進行所有相應的準備,為今年夏天的批准做好準備。

  • On Europe, I don't know the market question?

    關於歐洲,我不知道市場有什麼疑問?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Yes, it's more of a commercial question.

    是的,這更像是商業問題。

  • I would just add, we also got Breakthrough Designation from the FDA in the US for lenacapavir.

    我還要補充一點,我們的利那帕韋也獲得了美國 FDA 頒發的突破性療法認定。

  • And so we're excited about the potential for this launch this summer.

    因此,我們對今年夏天推出這款產品的潛力感到非常興奮。

  • And everything is on track for that.

    一切都在按計劃進行。

  • And our plans are obviously all the teams are working through to make sure we are ready for that launch.

    顯然,所有團隊都在努力完成我們的計劃,以確保我們為此次發布做好準備。

  • In Europe, 2 things.

    在歐洲,有兩件事。

  • One is the approval for Europe -- the potential approval, I should say, for Europe is one that we find exciting and one that we realize that prevention in Europe is really specific to certain markets more so than others.

    一是獲得歐洲的批准——應該說,獲得歐洲的潛在批准令我們感到興奮,我們意識到歐洲的預防措施確實針對某些市場,而非其他市場。

  • We are obviously going to do that in a tiered approach and make sure that we're really targeting both all key stakeholders.

    我們顯然將採取分層的方式來實現這一目標,並確保我們真正針對所有關鍵利害關係人。

  • That includes government health ministers, government stakeholders, KOLs, investigators with the PURPOSE 5 trial that we have running right now in the UK and in France and making sure that we work together really across different stakeholder groups to make sure that there's an opportunity for lenacapavir to have access in these countries and really make a difference for those markets.

    其中包括政府衛生部長、政府利益相關者、KOL、我們目前在英國和法國進行的 PURPOSE 5 試驗的研究人員,並確保我們真正與不同的利益相關者群體合作,以確保利那帕韋有機會在這些國家獲得使用,並真正為這些市場帶來變化。

  • So more to come on that.

    對此,我們也將進行更多探討。

  • We also think that the EU filing is an important one because of [EU4all], and that really is around providing access to those over 138 countries for low- and low-middle-income countries as well.

    我們也認為,由於 [EU4all] 的原因,向歐盟提交申請非常重要,這實際上也是為了讓 138 個國家的低收入和中低收入國家也能享受這項服務。

  • And so that's in line with the work that we're doing to ensure access everywhere around the world.

    這與我們為確保世界各地都能獲得服務所做的工作是一致的。

  • So more to come on that as we progress.

    隨著我們的不斷進步,還會有更多內容。

  • Operator

    Operator

  • Daina Graybosch, Leerink Partners.

    Daina Graybosch,Leerink Partners。

  • Daina Graybosch - Analyst

    Daina Graybosch - Analyst

  • Just one for Dietmar.

    僅此一件,獻給 Dietmar。

  • I wonder as you've come in new to the organization if you could give us your reflections on the competitiveness of the late-stage oncology portfolio, particularly what you think about TIGIT and Dom and Trodelvy as we come to more Phase 3 readouts.

    我想知道,由於您剛加入該組織,您是否可以告訴我們您對後期腫瘤學產品組合競爭力的看法,特別是隨著我們進入更多第 3 階段的數據,您對 TIGIT 以及 Dom 和 Trodelvy 的看法。

  • Dietmar Berger - Chief Medical Officer

    Dietmar Berger - Chief Medical Officer

  • Yes.

    是的。

  • Thanks, Daina, for the question, right?

    謝謝 Daina 提出這個問題,對吧?

  • As I join Gilead, right, Gilead is in a unique situation at this point with a well-diversified clinical pipeline or major LOEs before 2033, really upcoming key launches and strong news flow that I'm looking forward to and an exciting research portfolio and really deep scientific expertise that I consider critical, right, in these areas, whether it's virology, whether it's a long-standing history or whether it's immunology and oncology.

    在我加入吉利德之後,吉利德目前處於一個獨特的地位,它擁有多樣化的臨床管線或2033年之前的主要LOE、即將推出的關鍵產品和我期待的強勁新聞流,以及令人興奮的研究組合和真正深厚的科學專業知識,我認為在這些領域這些都至關重要,無論是病毒學、悠久的歷史,還是免疫學和腫瘤學。

  • Your specific question with regards to the later-stage portfolio, look, Trodelvy, the key studies are set at this point.

    您關於後期投資組合的具體問題,您看,Trodelvy,關鍵研究已經在這一點上確定了。

  • And we're looking forward to seeing the ASCENT-03 and ASCENT-04 studies in triple-negative breast cancer coming up during this year basically.

    我們期待看到今年內推出的針對三陰性乳癌的 ASCENT-03 和 ASCENT-04 研究。

  • So that question will be answered very soon.

    所以這個問題很快就會得到答案。

  • We also have the lung cancer studies in the first line setting really set up at this point.

    目前,我們也真正建立了針對第一線病患的肺癌研究。

  • And let me just remind you that Trodelvy is the only TROP2 ADC that has demonstrated overall survival in some of those studies, right?

    我只想提醒您,Trodelvy 是唯一在某些研究中證明整體生存率的 TROP2 ADC,對嗎?

  • So I think it's really differentiated molecule, and a lot of it will uncover itself in the very near future.

    所以我認為它是一種真正分化的分子,而且很多分子將在不久的將來顯露出來。

  • For TIGIT, I've always believed TIGIT is an interesting immuno-oncology target.

    對於 TIGIT,我一直相信 TIGIT 是一個有趣的免疫腫瘤學標靶。

  • There's potential for differentiation given the fact that sombenalumab has the Fc silent design.

    由於 sombenalumab 具有 Fc 靜默設計,因此存在差異化的潛力。

  • There were some encouraging early Phase 2 data like the ARC-7, the ARC-10 study, the H-gastric study.

    有一些令人鼓舞的早期第 2 階段數據,如 ARC-7、ARC-10 研究和 H-gastric 研究。

  • But those were, of course, small early data sets.

    但當然,這些只是早期的小數據集。

  • So again, we're awaiting the data.

    因此,我們再次等待數據。

  • There are 2 ongoing Phase 3 studies, STAR-121 and STAR-221, which really will define our path forward there.

    目前有兩項正在進行的 3 期研究,STAR-121 和 STAR-221,它們將真正決定我們前進的道路。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    富國銀行的莫希特·班薩爾 (Mohit Bansal)。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Welcome, Dietmar, to Gilead.

    歡迎 Dietmar 來到 Gilead。

  • So my question is regarding the sales growth for HIV quarter-over-quarter.

    我的問題是關於 HIV 藥物的季度銷售額成長。

  • It seems like you're calling out favorable inventory dynamics year-over-year as well.

    您似乎也指出庫存動態年比呈現良好勢頭。

  • So just wanted to understand, did you see more-than-normal inventory buildup in fourth quarter?

    所以只是想了解一下,您是否看到第四季度的庫存累積超過正常水平?

  • Because you're calling out year-over-year as well.

    因為你也是逐年呼籲。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Thanks, Mohit.

    謝謝,Mohit。

  • It's Johanna.

    是喬安娜。

  • So what we did see is obviously really strong demand in both the quarter-over-quarter as well as the full year-on-year Q4 over Q4 of the prior year.

    因此,我們確實看到,無論是季度環比還是全年同比,第四季的需求都明顯強勁。

  • We also did see seasonal inventory dynamics, and we see that on a quarter-on-quarter basis but also a little bit year-on-year.

    我們也確實看到了季節性庫存動態,並且我們看到這種動態是按季度計算的,但按年計算也有一點。

  • And what we had seen in 2023 is actually that inventory build across Q3 and Q4.

    我們在 2023 年看到的實際上是第三季和第四季的庫存增加。

  • In 2024, we saw it heavily in Q4 instead of across 2 quarters.

    到 2024 年,我們將在第四季度看到這一現象的嚴重性,而不是跨越兩個季度。

  • And so that's probably the biggest difference that we've seen from a year-on-year basis.

    這可能是我們從年比來看最大的差異。

  • But really, the number one driver across the board for HIV, first and foremost, has been that demand that has come through, namely on Biktarvy but also Descovy.

    但實際上,推動愛滋病毒治療的首要因素是對 Biktarvy 和 Descovy 的需求。

  • Operator

    Operator

  • Brian Abrahams, RBC Capital Markets.

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

  • Brian Abrahams - Analyst

    Brian Abrahams - Analyst

  • Congratulations on the quarter.

    恭喜本季取得佳績。

  • Maybe shifting gears to Livdelzi.

    也許會轉向 Livdelzi。

  • Curious if you could elaborate a little bit more on what you're observing in terms of just use pattern, prescriber base, the types of patients where this early uptake has come from and maybe how we should, at least qualitatively, think about the trajectory this year just given the high demand you're seeing off the bat.

    我很好奇,您是否可以更詳細地說明一下您在使用模式、處方基礎、早期採用的患者類型等方面的觀察結果,以及考慮到您一開始就看到的高需求,我們應該如何至少從定性上看待今年的發展軌跡。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Sure.

    當然。

  • Thanks for the question, Brian.

    謝謝你的提問,布萊恩。

  • It's Johanna.

    是喬安娜。

  • Yes.

    是的。

  • So with Livdelzi, we're really excited about how, not only are we seeing the progression, but it's definitely exceeding our internal expectations.

    因此對於 Livdelzi,我們感到非常興奮,我們不僅看到了進展,而且它絕對超出了我們的內部預期。

  • We've heard some really positive feedback on the differentiation of efficacy but also safety, not just the ALP but also just the overall biochemical response, the ALP normalization, and of course, the pruritus and the safety component to this.

    我們聽到了一些關於療效和安全性差異的非常正面的回饋,不僅是 ALP,還包括整體生化反應、ALP 正常化,當然還有搔癢和安全性成分。

  • We are seeing strong continuous week-over-week growth.

    我們看到每週都呈現強勁持續成長。

  • And so that's creating momentum as we go into 2025.

    這將為我們邁向 2025 年創造動力。

  • So we're very much looking forward to that.

    因此我們非常期待這一點。

  • And I think it has a lot to do with the experience, the heritage that we have in liver, the credibility that we bring with key stakeholders.

    我認為這與我們在肝臟方面的經驗、傳統以及我們在主要利益相關者中贏得的信譽有很大關係。

  • So very pleased about the payer access we're seeing is also in line with our expectations for a rare disease.

    我們很高興地看到,付款人的訪問權限也符合我們對罕見疾病的預期。

  • We're not seeing any major stragetic access for rate patients.

    我們沒有看到任何針對費率患者的主要策略途徑。

  • To your question about what type of patients, obviously, these are second-line patients in line with our indication.

    對於您關於什麼類型的患者的問題,顯然,這些都是符合我們適應症的第二線患者。

  • Generally speaking, these are second-line naive to second line.

    一般來說,這些都是二線天真到二線的。

  • And what I mean by that is, obviously, they are inadequate responders to UDCA and moving into the second line setting.

    我的意思是,顯然他們對 UDCA 的反應不足,因此轉而採用二線治療。

  • But it's not -- we're not seeing much of a shift between second line setting at this point in time, if that's what you're referring to.

    但事實並非如此——如果您指的是這個的話,我們目前還沒有看到第二線設定之間有太大的轉變。

  • So we think Livdelzi's trajectory is incredibly strong.

    因此我們認為 Livdelzi 的發展軌跡非常強勁。

  • And we believe 2025 is going to be where it really comes through from a momentum standpoint.

    我們相信,從動力角度來看,2025 年將是它真正突破的一年。

  • So we're excited to see what the future holds.

    所以我們很期待看到未來會發生什麼。

  • Operator

    Operator

  • Tyler Van Buren.

    泰勒·範布倫。

  • Tyler Van Buren - Analyst

    Tyler Van Buren - Analyst

  • Nice quarterly results.

    季度業績不錯。

  • Johanna, I have another one for you.

    約翰娜,我還有一個給你。

  • Just what led to the 16% year-over-year PrEP market growth and acceleration for 2024 that you highlighted?

    您強調的是什麼導致了 2024 年 PrEP 市場年增 16% 並加速成長?

  • Specifically, can you elaborate on some of those factors and whether you think those might serve as lasting tailwinds for the upcoming lenacapavir launch?

    具體來說,您能否詳細說明其中一些因素,以及您是否認為這些因素可能成為即將推出的利那帕韋的持久推動力?

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Yes.

    是的。

  • Thanks for the question, Tyler.

    謝謝你的提問,泰勒。

  • Yes, we were excited to see, right?

    是的,我們很高興看到,對吧?

  • We closed out the quarter at about 16% market growth.

    本季結束時,我們的市場成長率約為 16%。

  • That reflects a couple of things.

    這反映了幾件事。

  • Number one, just the value and noise around PURPOSE 1 and PURPOSE 2, I think, is giving some momentum to this market in prevention and what's to come.

    首先,我認為,圍繞目的 1 和目的 2 的價值和喧囂為預防市場以及未來的發展提供了一些動力。

  • But I would also say we doubled down from a market development standpoint.

    但我想說,從市場開發的角度來看,我們加倍努力。

  • So the team has really focused across many functions in this -- in our organization to really make sure that we were developing the prevention market and making sure it was set up for success, not only with the current agents today in the marketplace but as a setup as you think about the potential launch for lenacapavir.

    因此,團隊真正專注於組織中的多項職能,以確保我們正在開發預防市場,並確保它能夠取得成功,不僅要利用當今市場上的現有代理商,還要考慮到 lenacapavir 的潛在上市。

  • So we do think that is something that will carry through for the launch of lenacapavir and could actually accelerate it as well.

    因此,我們確實認為這將貫穿 lenacapavir 的上市進程,並且實際上也可以加速其上市進程。

  • Operator

    Operator

  • Ellie Merle, UBS.

    瑞銀的艾莉·梅爾(Ellie Merle)

  • Eliana Merle - Analyst

    Eliana Merle - Analyst

  • So for Livdelzi, how is the enrollment in the IDEAL study in the partial UDCA responders going?

    那麼對於 Livdelzi 來說,IDEAL 研究中部分 UDCA 響應者的招募情況如何?

  • And I guess, how are you thinking about how this study in the context of a potential label expansion and what this could mean for the size of the eligible patient population long term?

    我想,您如何看待這項研究在潛在標籤擴展的背景下如何進行,以及這對長期符合條件的患者群體規模意味著什麼?

  • Dietmar Berger - Chief Medical Officer

    Dietmar Berger - Chief Medical Officer

  • Yes.

    是的。

  • Thank you, Ellie, for the question.

    謝謝你,艾莉,提出這個問題。

  • This is Dietmar.

    這是迪特馬爾。

  • For the IDEAL study, it's on track at this point.

    對於 IDEAL 研究來說,目前一切進展順利。

  • So no further comments on that.

    因此對此沒有進一步的評論。

  • It does assess a separate second-line population to those patients partially responsive to UDCA, basically the AOP 1 to 1.67, which then would clearly extend Livdelzi's reach to an additional patient population, especially in the US here.

    它確實對那些對 UDCA 部分回應的患者進行了單獨的二線人群評估,基本上是 AOP 1 到 1.67,這顯然會將 Livdelzi 的覆蓋範圍擴大到更多的患者群體,尤其是在美國。

  • So we're really looking forward to seeing those data.

    所以我們非常期待看到這些數據。

  • Johanna Mercier - Chief Commercial Officer

    Johanna Mercier - Chief Commercial Officer

  • Yes.

    是的。

  • Maybe just to add to Dietmar's comments, 1/3 of the patients today are actually partial responders, so basically in line with what Dietmar was suggesting.

    也許只是為了補充 Dietmar 的評論,今天 1/3 的患者實際上是部分反應者,所以基本上符合 Dietmar 的建議。

  • And that volume is about 20,000 to 25,000 people in the US and about this number in Europe.

    在美國,這一數字約為 20,000 至 25,000 人,在歐洲,這一數字也大致如此。

  • So we are excited about the opportunity to expand our reach beyond second line.

    因此,我們很高興有機會將我們的影響力拓展到二線以外。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    考特尼·布林,伯恩斯坦。

  • Courtney Breen - Analyst

    Courtney Breen - Analyst

  • What I really wanted to focus on was small cell lung cancer.

    我真正想關注的是小細胞肺癌。

  • Obviously, you spoke about the Trodelvy study that you're initiating here.

    顯然,您談到了您在這裡發起的 Trodelvy 研究。

  • And Dietmar, would love your thoughts on kind of how you think kind of TROP2, DLL3, B7-H3 and all the other kind of targets that are being chased after in this space might stack up relative to another and how you think this market might shake out over the long term.

    迪特馬爾,我很想聽聽您對 TROP2、DLL3、B7-H3 以及該領域正在追逐的所有其他目標相對於其他目標的看法,以及您認為這個市場從長遠來看會如何發展的看法。

  • Dietmar Berger - Chief Medical Officer

    Dietmar Berger - Chief Medical Officer

  • Thanks for the question, Courtney.

    謝謝你的提問,考特尼。

  • I mean, first of all, I'm really glad to see progress in small cell lung cancer.

    我的意思是,首先,我很高興看到小細胞肺癌取得進展。

  • You know that for more than 30 years, these patients were treated with chemotherapy with less advancements basically.

    你知道,30多年來,這些病人基本上都是接受化療治療,但進展不大。

  • Now we do have those different tools available.

    現在我們確實有這些不同的工具可用。

  • TROP2, when you look at the Phase 2 data, they've actually been really impressive.

    TROP2,當您查看第二階段的數據時,它們實際上確實令人印象深刻。

  • There's clear TROP2 expression.

    有明顯的TROP2表達。

  • We've received breakthrough therapy designation from the FDA.

    我們已經獲得FDA的突破性治療認證。

  • We're planning to start the study during the first half of the year.

    我們計劃在今年上半年開始這項研究。

  • And I think this will be a really meaningful additional treatment option with the ADC with TROP2 targeting.

    我認為這將是針對 TROP2 的 ADC 的一個真正有意義的附加治療選擇。

  • When you look at some of the other targets, I mean, obviously, these are competitive.

    當你看看其他一些目標時,我的意思是,顯然這些都是有競爭力的。

  • I hope they will be basically adding more also to the benefit for patients.

    我希望他們也能為患者帶來更多好處。

  • I think TROP2 has the potential to be foundational in the second line setting here, and then we'll need to see the data there.

    我認為 TROP2 有可能成為這裡第二行設定的基礎,然後我們需要查看那裡的數據。

  • There have been mixed data on B7-H3, and DLL3 is certainly an interesting target also in the space.

    關於 B7-H3 的數據比較複雜,而 DLL3 在該領域無疑也是一個有趣的目標。

  • Operator

    Operator

  • That completes the time that we have for questions.

    我們的提問時間到此結束。

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

    現在我請丹作結束語。

  • Daniel O'Day - Chairman of the Board, Chief Executive Officer

    Daniel O'Day - Chairman of the Board, Chief Executive Officer

  • Thank you, Rebekah.

    謝謝你,麗貝卡。

  • I appreciate all of you joining today.

    我感謝大家今天的參加。

  • Let me close by thanking the Gilead teams for another exceptionally strong quarter and for driving the momentum that we are carrying into 2025.

    最後,我要感謝吉利德團隊又一個異常強勁的季度,並推動我們邁向 2025 年的良好勢頭。

  • The consistent revenue we've seen quarter after quarter and the strong demand across all 3 of our therapeutic areas is the foundation we are building from as we deliver on our potential in the months and years ahead.

    我們每季都保持穩定的收入,並且我們三個治療領域的需求都十分強勁,這是我們在未來幾個月和幾年內發揮潛力的基礎。

  • The potential comes from having the most robust and diverse pipeline of Gilead's history.

    這項潛力源自於吉利德擁有史上最強大、最多元的管道。

  • And with recent and imminent launches across our therapeutic areas, no major LOEs on the horizon and disciplined expense management, we're set to deepen impact for patients that we serve and deliver compelling returns for our shareholders.

    隨著我們在各個治療領域近期和即將推出的產品、沒有重大的 LOE 以及嚴格的費用管理,我們準備為所服務的患者提供更深遠的影響,並為我們的股東帶來可觀的回報。

  • We look forward to updating you on our progress in the months ahead.

    我們期待在未來幾個月向您通報我們的進展。

  • And with that, I'll turn it back over to Jacquie.

    說完這些,我會把話題轉回給 Jacquie。

  • Jacquie Ross - Investor Relations

    Jacquie Ross - Investor Relations

  • Thank you, Dan, and thank you all for joining us today.

    謝謝你,丹,也謝謝大家今天加入我們。

  • One final housekeeping item.

    最後再說一件整理事項。

  • I can share that we are tentatively planning to release our first quarter 2025 earnings results on April 24, 2025.

    我可以分享的是,我們暫定於 2025 年 4 月 24 日發布 2025 年第一季的收益結果。

  • Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then.

    請注意,此日期是臨時的,可能會更改以適應從現在到那時出現的時間衝突。

  • As always, we will announce our confirmed date following the close of the quarter.

    與往常一樣,我們將在本季結束後公佈確認的日期。

  • We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout 2025.

    感謝您對吉利德的持續關注,我們期待在 2025 年向您通報我們的進展。

  • Thank you

    謝謝