吉利德科學 (GILD) 2024 Q3 法說會逐字稿

Good afternoon, everyone, and welcome to Gilead's third-quarter 2024 earnings conference call.

大家下午好，歡迎參加吉利德 2024 年第三季財報電話會議。

My name is Rebekah and I'll be your host for today in a moment.

我叫麗貝卡，稍後我將擔任今天的主持人。

(Operator Instructions)

（操作員說明）

I'll now hand the call over to Jacquie Ross, Vice President of Investor Relations and Corporate Strategic Finance.

我現在將把電話轉給投資者關係和企業策略財務副總裁 Jacquie Ross。

Thank you, Rebecca.

謝謝你，麗貝卡。

Just after market closed today, we issued a press release with earnings results for the third quarter of 2024.

今天收盤後，我們發布了一份新聞稿，其中包含 2024 年第三季的獲利結果。

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 的投資者部分取得。

The speakers on today’s call will be our Chairman and Chief Executive Officer, Daniel O’Day; our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Merdad Parsey; and our Chief Financial Officer, Andrew Dickinson.

今天電話會議的講者是我們的董事長兼執行長 Daniel OâDay；我們的首席商務官 Johanna Mercier；我們的首席醫療官 Merdad Parsey；以及我們的財務長安德魯·迪金森。

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，我們將開始問答電話，Kite 執行副總裁 Cindy Perettie 將加入團隊。

Before we get started, let me remind you that we will be making forward-looking statements.

在我們開始之前，請允許我提醒您，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，以了解與前瞻性陳述相關的風險和不確定性，這些風險和不確定性可能導致實際結果出現重大差異。

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

這樣，我就把電話轉給丹。

Thank you, Jacquie, and good afternoon, everyone.

謝謝你，杰奎，大家下午好。

The team and I are pleased to share Gilead's third-quarter results, highlighting another very strong quarter of commercial and operational execution with robust year-over-year revenue performance across HIV, oncology, and liver disease, including 9% growth in HIV.

我和我的團隊很高興分享吉利德第三季度的業績，突顯了吉利德在商業和營運執行方面又一個非常強勁的季度，在愛滋病毒、腫瘤學和肝病領域的收入同比增長強勁，其中艾滋病毒增長了9%。

We also delivered strong bottom-line results that highlight the leverage in our business model and reflect our ongoing commitment to disciplined expense management.

我們也實現了強勁的獲利業績，凸顯了我們業務模式的槓桿作用，並反映了我們對嚴格費用管理的持續承諾。

Based on our financial results here to date, we are increasing our 2024 guidance across almost every metric including revenue and non-GAAP gross margin, operating income, and EPS.

根據我們迄今為止的財務業績，我們正在提高幾乎所有指標的 2024 年指導，包括收入和非 GAAP 毛利率、營業收入和每股收益。

We continued to make excellent progress in our virology and inflammation programs in the third quarter.

第三季度，我們的病毒學和發炎計畫繼續取得出色進展。

The results from the PURPOSE 2 study which build on the 100% efficacy shown in PURPOSE 1 demonstrate lenacapavir's unmatched clinical profile observed for HIV prevention.

目的 2 研究的結果建立在目的 1 所示 100% 效力的基礎上，證明了來那卡韋在 HIV 預防方面具有無與倫比的臨床特徵。

If approved, lenacapavir as the first twice yearly subcutaneous injection for HIV prevention could make a major impact on global public health and significantly catalyze the prevention market.

如果獲得批准，來那卡韋作為第一個用於預防愛滋病毒的每年兩次的皮下注射劑，可能會對全球公共衛生產生重大影響，並極大地促進預防市場的發展。

I'm pleased to share that the FDA recently granted breakthrough therapy designation to lenacapavir and we are on track to file before the end of this year.

我很高興地告訴大家，FDA 最近授予了lenacapavi 突破性療法認定，我們預計在今年年底前提交申請。

We look forward to sharing information on our plans for lenacapavir and the rest of our leading HIV portfolio at our HIV Analyst Event on December 10.

我們期待在 12 月 10 日的 HIV 分析師活動上分享有關 lenacapavi 和我們其他領先 HIV 產品組合的計劃的資訊。

We are very encouraged by the initial launch of Livdelzi for primary biliary cholangitis or PBC, which was granted accelerated approval by the FDA in August.

我們對 Livdelzi 首次上市治療原發性膽汁性膽管炎或 PBC 感到非常鼓舞，該藥物於 8 月獲得 FDA 加速批准。

Livdelzi is a highly differentiated option for people with PBC who do not respond well to first line therapy.

對於第一線治療反應不佳的 PBC 患者來說，Livdelzi 是一種高度差異化的選擇。

Demand in the third quarter was ahead of our internal expectations, and we expect to see growing momentum into 2025 and beyond.

第三季的需求超出了我們的內部預期，我們預計 2025 年及以後將出現成長勢頭。

Livdelzi brings the number of innovative therapies launched by Gilead since 2019 to six, representing another step towards our goal of delivering at least 10 transformative therapies by 2030.

Livdelzi 讓吉利德自 2019 年以來推出的創新療法數量達到 6 種，這代表著我們向 2030 年提供至少 10 種變革性療法的目標又邁進了一步。

Moving to oncology, we are excited to share preliminary data from the registrational Phase 2 iMMagine-1 study of anito-cel for the treatment of relapsed or refractory multiple myeloma at ASH next month, in addition to updated data from the Phase 1 study together with our partner, Arcellx.

轉向腫瘤學，我們很高興在下個月的 ASH 上分享 anito-cel 用於治療復發或難治性多發性骨髓瘤的註冊 2 期 iMMagine-1 研究的初步數據，以及 1 期研究的更新數據以及我們的合作夥伴，Arcellx。

We're also pleased to have begun the Phase 3 iMMagine-3 study in earlier line patients.

我們也很高興在早期患者中開始了 iMMaine-3 3 期研究。

The combination of anito-cel's potential best in class clinical profile with Kite's leading cell therapy manufacturing has the ability to transform care for a large number of multiple myeloma patients.

anito-cel 潛在的同類最佳臨床特徵與 Kite 領先的細胞療法製造相結合，有能力改變大量多發性骨髓瘤患者的護理。

We continue to evolve our oncology program in response to clinical data, regulatory feedback, and the competitive environment.

我們根據臨床數據、監管回饋和競爭環境不斷發展我們的腫瘤學課程。

We are carefully prioritizing our resources for the most promising programs.

我們正在謹慎地將我們的資源優先用於最有前途的項目。

For example, we are advancing Trodelvy in first line PD-L1-high metastatic non-small cell lung cancer where we have seen supportive data in combination with pembro while discontinuing development in second line plus.

例如，我們正在一線 PD-L1 高轉移性非小細胞肺癌中推進 Trodelvy，我們已經看到了與 pembro 聯合使用的支持性數據，同時停止了二線+的開發。

We are also starting a new program for small cell lung cancer based on promising efficacy data from the Phase 2 TROPiCS-03 basket trial.

我們也根據 2 期 TROPiCS-03 籃子試驗的有希望的療效數據，啟動了一項針對小細胞肺癌的新計畫。

Touching briefly on slide 6, we have completed all of the clinical milestones and updates we targeted for 2024 and look forward to a strong end to the year with key presentations coming up at ASH and our HIV analyst event in December.

簡單介紹一下投影片 6，我們已經完成了 2024 年目標的所有臨床里程碑和更新，並期待在 ASH 和 12 月的 HIV 分析師活動上發表重要演講，為這一年畫上圓滿的句號。

Those are the main points I wanted to share for now in what has been a very strong third quarter, thanks to the tremendous efforts of the Gilead teams.

這些是我現在想分享的要點，在吉利德團隊的巨大努力下，第三季表現非常強勁。

I look forward to our Q&A session at the end, and now, I will pass it on to Johanna.

我期待著最後的問答環節，現在我將把它轉給約翰娜。

Thanks, Dan, and good afternoon, everyone.

謝謝丹，大家下午好。

It was another strong quarter of commercial execution across the business and I'm proud of the work the teams continue to do to expand the reach of our medicines to many more people and patients around the world.

這是整個業務的商業執行力又一個強勁的季度，我對團隊為將我們的藥物擴大到世界各地更多的人和患者而繼續所做的工作感到自豪。

As shown on slide 8, total product sales excluding Veklury were $6.8 billion in the third quarter, up 7% year over year, reflecting strong growth across HIV, oncology, and liver disease.

如投影片 8 所示，第三季不包括 Veklury 的產品總銷售額為 68 億美元，較去年同期成長 7%，反映出愛滋病、腫瘤和肝病領域的強勁成長。

Including Veklury, total product sales were $7.5 billion, up 7% year over year.

包括 Veklury 在內，產品總銷售額為 75 億美元，較去年同期成長 7%。

Starting with HIV on slide 9, sales of $5.1 billion were up 9% year over year and 7% sequentially, primarily driven by higher average realized price due to shifts in channel mix and higher demand across treatment and PrEP.

從幻燈片 9 上的 HIV 開始，銷售額為 51 億美元，同比增長 9%，環比增長 7%，這主要是由於渠道組合的變化以及治療和 PrEP 需求的增加導致平均實現價格上漲。

The third quarter once again demonstrated the quarterly pricing variability we see in HIV.

第三季再次證明了我們在愛滋病毒領域看到的季度定價波動。

Specifically, we saw adjustments to government channels where there's a multi quarter lag for certain claims data.

具體來說，我們看到政府管道的調整，某些索賠數據存在多個季度的滯後。

As a result, the quarter reflected more favorable average realized pricing.

因此，本季反映出更有利的平均實現定價。

Year to date, HIV sales have grown 5%, well above our prior full-year growth target of 4%.

今年迄今為止，HIV 銷售額已成長 5%，遠高於我們先前 4% 的全年成長目標。

With that outperformance in mind, we're increasing our full-year HIV growth expectation to 5%,and we remind you to focus on full year versus quarterly trends.

考慮到這一優異表現，我們將全年愛滋病毒成長預期提高至 5%，並提醒您專注於全年與季度趨勢。

To that end, for the fourth quarter, in particular, we expect HIV sales to be roughly flat quarter over quarter with continued demand growth and modest seasonal inventory bills, offset by the third-quarter pricing dynamics discussed earlier that are not expected to repeat.

為此，特別是在第四季度，我們預計愛滋病毒銷售額將與上一季度大致持平，需求持續增長，季節性庫存費用適度，但被前面討論的第三季度定價動態所抵消，預計不會重複。

Turning to slide 10, Biktarvy third quarter sales of $3.5 billion increased 13% year over year, driven by higher demand as well as higher average realized price due to shifts in channel mix, partially offset by inventory dynamics.

轉向投影片 10，Biktarvy 第三季銷售額為 35 億美元，年增 13%，這是由於需求增加以及通路組合變化帶來的平均實現價格上漲推動的，但庫存動態部分抵消了這一影響。

Sequentially, sales were up 7%, primarily driven by channel mix and higher demand.

隨後，銷售額成長了 7%，這主要是由通路組合和更高的需求推動的。

In the US and across major markets, Biktarvy continues to be the regimen of choice for those starting treatment and switching therapies and has grown for 25 consecutive quarters.

在美國和主要市場，Biktarvy 仍然是開始治療和轉換療法的人的首選治療方案，並且連續 25 個季度成長。

In the US, Biktarvy share grew to over 49%, up more than 2% year over year and remains the leading regimen for HIV treatment.

在美國，Biktarvy 的份額增長至 49% 以上，年增長超過 2%，仍然是愛滋病毒治療的領先療法。

Gilead is well positioned to maintain its leadership in the HIV treatment market with four new regimens by the end of 2030.

到 2030 年底，吉利德將憑藉四種新療法保持在 HIV 治療市場的領先地位。

Overall, the HIV treatment market continues to grow in line with our expectations of 2% to 3% annually.

整體而言，HIV 治療市場持續成長，符合我們每年 2% 至 3% 的預期。

Moving to Descovy, third-quarter sales were $586 million, up 15% year over year, reflecting higher demand and average realized price due to channel mix, partially offset by inventory dynamics.

轉向 Descovy，第三季銷售額為 5.86 億美元，年增 15%，反映出通路組合帶來的需求和平均實現價格的增加，但部分被庫存動態所抵消。

Sequentially, sales were up 21%, primarily driven by channel mix and higher demand.

隨後，銷售額成長了 21%，這主要是由通路組合和更高的需求推動的。

The US PrEP market continues to demonstrate robust growth up 13% year over year.

美國 PrEP 市場持續呈現強勁成長，較去年同期成長 13%。

And Descovy for PrEP remains the leading branded option capturing over 40% market share despite the availability of generics and other regimens.

儘管有仿製藥和其他治療方案，但用於 PrEP 的 Descovy 仍然是領先的品牌選擇，佔超過 40% 的市場份額。

Overall, Descovy for PrEP sales make up an increasing portion of total Descovy sales representing roughly 80% in the third quarter.

總體而言，用於 PrEP 的 Descovy 銷售額在 Descovy 總銷售額中所佔的比例越來越大，約佔第三季的 80%。

This is a strong foundation as we prepare for the first anticipated commercial launch of lenacapavir for PrEP next year. lenacapavir's remarkable clinical profile and unmatched twice-yearly administration offer the potential to redefine the HIV prevention market.

這是我們為明年首次商業推出用於 PrEP 的 Lenacapavir 做準備的堅實基礎。 lenacapavi 卓越的臨床表現和無與倫比的每年兩次給藥提供了重新定義愛滋病毒預防市場的潛力。

And we look forward to sharing more details on our commercialization plans and treatment programs at our HIV analyst event in December.

我們期待在 12 月的 HIV 分析師活動中分享有關我們的商業化計劃和治療計劃的更多細節。

In the meantime, we look to file for approval in the US before the end of the year and are well underway with our preparations for the first commercial launch in 2025.

同時，我們希望在今年年底前在美國申請批准，並正在為 2025 年首次商業發布做準備。

In addition to our commercial plans, we're particularly proud of our commitment to make lenacapavir available in 120 high-incident, resource-limited countries as quickly as possible, ensuring access for lenacapavir for PrEP is made as broadly available upon approval.

除了我們的商業計劃之外，我們特別自豪的是我們致力於盡快在 120 個高發、資源有限的國家提供 lenacapvir，確保在獲得批准後廣泛提供 lenacapvir 用於 PrEP。

Moving to the liver disease portfolio on slide 11, sales of $733 million in the third quarter were up 4% year over year, driven by increased demand across our viral hepatitis portfolio, partially offset by pricing dynamics including shifts in channel mix in the US.

轉到投影片11 上的肝病產品組合，第三季的銷售額為7.33 億美元，年增4%，這得益於我們的病毒性肝炎產品組合需求增加，但部分被定價動態（包括美國通路組合的變化）所抵消。

Sequentially, after an incredibly strong second quarter, sales declined 12% primarily driven by inventory dynamics and fewer patient starts in HCV.

隨後，在經歷了極其強勁的第二季度後，銷售額下降了 12%，這主要是由於庫存動態和 HCV 患者開始減少所致。

Turning to slide 12, in mid-August, we launched live Livdelzi in the US for PBC with the first prescription written within a few hours of the accelerated approval.

轉向幻燈片 12，8 月中旬，我們在美國為 PBC 推出了即時 Livdelzi，並在加速批准後的幾個小時內開出了第一個處方。

Furthermore, with 100% of our US commercial organization trained by the time of launch, we quickly reached more than 1,000 of our target prescribers within the first several weeks.

此外，我們的美國商業組織在啟動時已 100% 接受過培訓，因此在最初幾週內我們很快就涵蓋了 1,000 多名目標處方者。

Overall, we're very encouraged with the patient demand.

總的來說，我們對患者的需求感到非常鼓舞。

We're seeing so far which is ahead of our internal expectations.

到目前為止，我們看到這超出了我們的內部預期。

We believe this reflects the differentiated profile of Livdelzi as the only approved therapy with statistically significant improvements in both ALP and pruritus as well as an established safety profile.

我們認為，這反映了 Livdelzi 的差異化特徵，它是唯一一種獲得批准的療法，在 ALP 和瘙癢方面均具有統計上顯著的改善，並且具有既定的安全性。

Sales in the third quarter were modest as we expected in the low-single-digit millions and reflective of the ramp up time required to onboard patients and providers and to work through step edits and prior authorizations that are normal for a rare disease launch.

第三季的銷售額溫和，正如我們預期的低個位數數百萬美元，這反映了患者和提供者加入以及完成步驟編輯和事先授權所需的時間，這對於罕見疾病的推出來說是正常的。

We expect to start building momentum as we enter 2025, when we look to a more meaningful sales contribution.

進入 2025 年，我們預計將開始累積動力，屆時我們將尋求更有意義的銷售貢獻。

Outside the US, launch preparations are ongoing and we look forward to the European regulatory decision in early 2025.

在美國以外，上市準備工作正在進行中，我們期待歐洲監管部門在 2025 年初做出決定。

Moving to slide 13, Veklury has continued to remain the antiviral standard of care for hospitalized patients treated for COVID-19, including in the US with more than 60% share in this setting.

轉向幻燈片 13，Veklury 繼續保持為接受 COVID-19 住院治療的患者的抗病毒護理標準，其中在美國，這種情況所佔比例超過 60%。

Altogether, with higher-than-expected hospitalizations in the summer months, sales in the third quarter were up 9% year over year to $692 million. Year-to-date

總而言之，由於夏季住院人數高於預期，第三季銷售額年增 9%，達到 6.92 億美元。今年迄今

sales of $1.5 billion are now well ahead of our initial full-year guidance of $1.3 billion.

目前 15 億美元的銷售額遠高於我們最初的 13 億美元全年指引。

As a result, we're raising our full year guidance for Veklury to approximately $1.8 billion.

因此，我們將 Veklury 的全年指引提高至約 18 億美元。

Now turning to oncology on slide 14, Gilead and Kite therapies have treated more than 65,000 patients globally, highlighting our continued growing reach.

現在轉向幻燈片 14 上的腫瘤學，吉利德和 Kite 療法已在全球治療了超過 65,000 名患者，凸顯了我們持續成長的影響力。

Sales for the quarter were $816 million, up 6% year over year, primarily driven by Trodelvy growth.

該季度銷售額為 8.16 億美元，年增 6%，主要受到 Trodelvy 成長的推動。

Sequentially, oncology sales were down 3% with growth in Trodelvy offset by a decline in cell therapy.

隨後，腫瘤學銷售額下降了 3%，Trodelvy 的成長被細胞療法的下降所抵消。

Beginning with Trodelvy on slide 15, sales of $332 million were up 17% year over year and 4% quarter over quarter, reflecting higher demand in all regions.

從幻燈片 15 上的 Trodelvy 開始，銷售額為 3.32 億美元，年增 17%，季增 4%，反映出所有地區的需求增加。

In breast cancer, Trodelvy remains well positioned as the only approved and commercially available TROP-2-directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancers.

在乳癌領域，Trodelvy 仍然是唯一經批准且可商業化的 TROP-2 導向 ADC，在兩種類型的轉移性乳癌中證明了具有臨床意義的生存益處。

Notably, Trodelvy is the standard of care for second line metastatic triple-negative breast cancer, with ongoing adoption in the pretreated HR positive/HER2 negative metastatic breast cancer setting.

值得注意的是，Trodelvy 是二線轉移性三陰性乳癌的治療標準，在接受過治療的 HR 陽性/HER2 陰性轉移性乳癌環境中持續採用。

We're pleased to see both indications contribute to Trodelvy's growth year over year despite an evolving competitive landscape.

儘管競爭格局不斷變化，我們很高興看到這兩個指標都有助於 Trodelvy 逐年成長。

Turning to slide 16, and on behalf of Cindy and the Kite team, cell therapy sales of $485 million in the third quarter were flat year over year with strong 23% growth outside the US, offset by the US.

轉向幻燈片 16，代表 Cindy 和 Kite 團隊，第三季細胞療法銷售額為 4.85 億美元，與去年同期持平，美國以外地區強勁增長 23%，但被美國市場所抵消。

Sequentially, total cell therapy sales were down 7% due to competitive headwinds, both in and out of class in the US, which we expect to continue into 2025.

隨後，由於美國課堂內外的競爭逆風，細胞療法總銷售額下降了 7%，我們預計這種情況將持續到 2025 年。

As a pioneer in cell therapy, Kite's focus is to expand overall utilization and increase cost share.

作為細胞療法的先驅，Kite 的重點是擴大整體利用率並增加成本份額。

As part of this work, we're partnering with government agencies and health care associations to amplify education of the benefits of CAR T and remove barriers to access.

作為這項工作的一部分，我們正在與政府機構和醫療保健協會合作，加強對 CAR T 益處的教育並消除獲取障礙。

To date, only two of every 10 eligible patients receive CAR T in second line plus large B cell lymphoma in the US.

迄今為止，在美國，每 10 名符合條件的患者中只有兩人接受二線加大 B 細胞淋巴瘤的 CAR T 治療。

And we are committed to removing these barriers so we can deliver potentially curative therapies like Yescarta to more patients.

我們致力於消除這些障礙，以便我們能夠為更多患者提供像 Yescarta 這樣的潛在治癒療法。

In the community setting, Kite is leading the way in identifying and lowering barriers and building the right ecosystem to enable more people to receive CAR T beyond the reach of an academic medical institution.

在社區環境中，Kite 在識別和降低障礙以及建立正確的生態系統方面處於領先地位，使更多的人能夠獲得超出學術醫療機構能力範圍的 CAR T 治療。

Today, CAR T sites often need to be accredited, typically by the Foundation for the Accreditation of Cellular Therapy or FACT and this requirement has been highlighted as a hurdle for our community partners to achieve national payer reimbursement.

如今，CAR T 站點通常需要獲得認證，通常需要獲得細胞治療認證基金會 (FACT) 的認證，這項要求已被強調為我們的社區合作夥伴實現國家付款人報銷的障礙。

In the meantime, we're pleased to share that we have treated our first few patients as part of our community strategy demonstrating that we can deliver Yescarta in this setting.

同時，我們很高興地告訴大家，作為我們社區策略的一部分，我們已經治療了首批幾名患者，這表明我們可以在這種情況下提供 Yescarta。

Outside the US, we saw year-over-year demand growth as we continue to expand into the second line relapsed or refractory large B cell lymphoma setting in Europe and launch in new markets.

在美國以外，隨著我們繼續擴展到歐洲的二線復發或難治性大 B 細胞淋巴瘤治療領域並在新市場推出，我們看到了需求的逐年增長。

In particular, we're encouraged by our progress in Japan where we have onboarded more than 50 authorized treatment centers in little over a year with more to come in the near future.

尤其是，我們在日本的進展令我們深受鼓舞，在一年多的時間裡，我們已經在日本建立了 50 多個授權治療中心，並且在不久的將來還會有更多中心加入。

Overall, I would like to thank the commercialization teams for their hard work to deliver another strong quarter and first nine months of the year with launch activities underway in PBC and for HIV prevention launch. next year.

總的來說，我要感謝商業化團隊的辛勤工作，透過 PBC 正在進行的啟動活動和愛滋病毒預防啟動，為今年的季度和前九個月帶來了另一個強勁的表現。明年。

Our teams are excited to bring our transformative medicines to many more people and patients globally.

我們的團隊很高興能夠將我們的變革性藥物帶給全球更多的人和患者。

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

接下來，我會將電話轉交給 Merdad。

Thank you, Johanna.

謝謝你，約翰娜。

We're very pleased to wrap up the third quarter with another exciting update from our PURPOSE program evaluating lenacapavir for HIV prevention.

我們很高興以我們的目的計劃的另一個令人興奮的更新來結束第三季度，該計劃評估了來那卡韋對愛滋病毒的預防作用。

As shown on slide 18, we shared two oral presentations on our PURPOSE 2 HIV prevention trial at the HIV Research for Prevention Conference in October.

如投影片 18 所示，我們在 10 月的愛滋病毒預防研究會議上分享了關於我們的目的 2 愛滋病毒預防試驗的兩場口頭報告。

Following the remarkable 100% efficacy reported from an interim analysis of the PURPOSE 1 trial in cisgender women in June, PURPOSE 2 was also stopped at the interim in September.

繼 6 月對順性別女性進行的 PURPOSE 1 試驗中期分析報告顯示顯著的 100% 療效後，PURPOSE 2 也於 9 月中期停止。

Notably, twice yearly, subcutaneous lenacapavir significantly reduced incidence of HIV infections compared to both background HIV incidence and Truvada in the exceptionally diverse population of cisgender men and gender diverse people in a Phase 3 prevention trial.

值得注意的是，在一項三期預防試驗中，與背景愛滋病毒發病率和特魯瓦達相比，每年兩次皮下注射來那卡韋在順性別男性和性別多樣化人群中顯著降低了艾滋病毒感染率。

These PURPOSE 1 and 2 results demonstrated lenacapavir's unprecedented results for HIV prevention.

這些目的 1 和目的 2 結果證明了來那卡韋在預防愛滋病毒方面取得了前所未有的成果。

We look forward to sharing additional insights at the HIV Glasgow Meeting next week including persistence data from PURPOSE 1 and a deeper look into the efficacy data from PURPOSE 2.

我們期待在下週的 HIV 格拉斯哥會議上分享更多見解，包括目的 1 的持久性數據以及對目的 2 的功效數據的更深入研究。

Based on these data, FDA has now granted breakthrough therapy designation for lenacapavir for HIV prevention.

基於這些數據，FDA 現已授予 Lenacapavi 用於預防愛滋病毒的突破性療法認定。

We continue to target regulatory submission before the end of the year in the US while at the same time preparing for filings with other global regulatory authorities.

我們繼續致力於在今年年底前向美國監管機構提交申請，同時準備向其他全球監管機構提交申請。

Beyond our registrational PURPOSE 1 and 2 programs, we continue to generate additional data from the Phase 2 PURPOSE 3, 4, and 5 trials in key populations across the US, UK, and France.

除了我們的註冊 PURPOSE 1 和 2 計劃外，我們還繼續從美國、英國和法國關鍵人群的 2 期 PURPOSE 3、4 和 5 試驗中產生更多數據。

These studies are intended to contribute additional data in communities where the use of or access to prevention options have historically been challenging.

這些研究旨在為歷史上難以使用或取得預防方案的社區提供更多數據。

Turning to our HIV treatment pipeline on slide 19, we continue to make strong progress in developing novel regimens, including a once-daily oral regimen with two backbone therapies, lenacapavir and bictegravir.

轉向幻燈片 19 上我們的 HIV 治療管道，我們在開發新療法方面繼續取得重大進展，包括每日一次的口服療法以及兩種主要療法（lenacapavir 和 bictegravir）。

This novel combination has the potential to provide another effective daily oral option for people living with HIV, including the 6% to 8% of people currently on complex regimens.

這種新穎的組合有可能為 HIV 感染者（包括目前接受複雜治療方案的 6% 至 8% 的人）提供另一種有效的日常口服選擇。

Recently, we completed enrollment of the Phase 3 ARTISTRY-1 trial within nine months of FPI, and are on track to complete enrollment in ARTISTRY-2 by early 2025.

最近，我們在 FPI 後的 9 個月內完成了 ARTISTRY-1 3 期試驗的註冊，並預計在 2025 年初完成 ARTISTRY-2 的註冊。

Further, we've made strong progress for our two once-weekly oral programs.

此外，我們在兩個每週一次的口語課程方面取得了巨大進展。

The Phase 2 study of our wholly owned combination of GS-4182, a pro drug of lenacapavir with enhanced oral bioavailability and GS-1720, a long acting integrase inhibitor, has now completed enrollment within two months of FPI.

我們全資擁有的GS-4182（一種具有增強口服生物利用度的lenacapavir前藥）和GS-1720（一種長效整合酶抑制劑）組合的2期研究現已在FPI後兩個月內完成入組。

And, we've enrolled our first participants into the Phase 3 ISLEND 1 and ISLEND 2 trials, evaluating the oral combination of lenacapavir with Merck's NRTTI islatravir for biologically suppressed people with HIV.

而且，我們已經招募了第一批參與者參加 3 期 ISLEND 1 和 ISLEND 2 試驗，評估 Lenacapavir 與默克公司的 NRTTI islatravir 的口服組合對生物抑制的 HIV 感染者的療效。

We presented week 48 data from the Phase 2 trial, evaluating this once-weekly combination in a similar population at IDWeek.

我們展示了 2 期試驗第 48 週的數據，在 IDWeek 的類似人群中評估了這種每週一次的組合。

Participants in both the lenacapavir plus islatravir and Biktarvy treatment arms maintain high rates of biologic suppression and no participants discontinued due to lymphocyte count decreases.

來那卡韋加伊拉曲韋和 Biktarvy 治療組的參與者均保持較高的生物抑制率，且沒有參與者因淋巴球數減少而停藥。

Moving to our liver disease portfolio on slide 20, FDA granted Livdelzi an accelerated approval for the treatment of PBC in combination with UDCA in certain adults who have an inadequate response to the UDCA or as monotherapy in certain patients unable to tolerate UDCA.

轉到幻燈片 20 上我們的肝病產品組合，FDA 加速批准 Livdelzi 用於與 UDCA 聯合治療某些對 UDCA 反應不足的成人的 PBC 治療，或作為某些無法耐受 UDCA 的患者的單一療法。

We have already filed with EMA an expected decision early next year.

我們已經向 EMA 提交了預計明年初的決定。

As part of the accelerated approval process, we continue to recruit for our confirmatory Phase 3 AFFIRM trial, evaluating seladelpar for improvement in event-free survival.

作為加速審批流程的一部分，我們繼續招募參加我們的驗證性 3 期 AFFIRM 試驗，評估 seladelpar 對無事件存活率的改善。

Further, our Phase 3 IDEAL trial is ongoing and offers us an opportunity to understand the effect of seladelpar in normalizing alkaline phosphatase in a broader set of PBC patients who had an incomplete response to UDCA.

此外，我們的 3 期 IDEAL 試驗正在進行中，使我們有機會了解 seladelpar 在對 UDCA 反應不完全的更廣泛的 PBC 患者中使鹼性磷酸酶正常化的效果。

Switching now to oncology, on slide 21, we continue to evolve our late-stage clinical programs in lung cancer in response to clinical data and the changing landscape.

現在轉向腫瘤學，在幻燈片 21 上，我們根據臨床數據和不斷變化的情況繼續發展肺癌的後期臨床項目。

Reflective of our commitment to prioritizing the most significant opportunities across all our therapeutic areas, we have decided to discontinue further evaluation of Trodelvy in second line plus metastatic non-small cell lung cancer based on discussions with regulators following the EVOKE-01 readout earlier this year.

為了體現我們優先考慮所有治療領域中最重要機會的承諾，根據今年早些時候 EVOKE-01 讀數後與監管機構的討論，我們決定停止對 Trodelvy 在二線加轉移性非小細胞肺癌中的進一步評估。

In the front line, based on the totality of the data from the Phase 2 EVOKE-02 trial, we believe Trodelvy in combination with the PD-1 inhibitor without the addition of chemotherapy may have the greatest potential in this setting.

在第一線，根據 2 期 EVOKE-02 試驗的全部數據，我們相信 Trodelvy 與 PD-1 抑制劑聯合而不添加化療可能在這種情況下具有最大的潛力。

To that end, our Phase 3 EVOKE-03 study of Trodelvy plus pembro is ongoing in first line patients with PD-L1-high metastatic non-small cell lung cancer.

為此，我們正在 PD-L1 高轉移性非小細胞肺癌一線患者中進行 Trodelvy 聯合 pembro 的 3 期 EVOKE-03 研究。

Separately, we shared promising data for Trodelvy in extensive stage small-cell lung cancer from our Phase 2 TROPiCS-03 basket trial and plan to advance development of Trodelvy in this population to a Phase 3 trial.

另外，我們分享了 Trodelvy 在廣泛期小細胞肺癌中的有希望的數據，這些數據來自我們的 2 期 TROPiCS-03 籃子試驗，併計劃將 Trodelvy 在該人群中的開發推進到 3 期試驗。

We also look forward to sharing the results from part one of the Phase 2 ARC-10 trial at the SITC meeting later this week, further adding to the body of data on domvanalimab, our Fc-silent anti-TIGIT.

我們也期待在本週稍後的 SITC 會議上分享 ARC-10 2 期試驗第一部分的結果，進一步補充我們的 Fc 沉默抗 TIGIT 藥物 domvanalimab 的數據主體。

As a reminder, we discontinued enrollment of ARC 10 earlier this year to prioritize the ongoing first line Phase 3 dom studies, STAR-121 in metastatic non-small cell lung cancer and STAR-221 in upper GI cancers.

提醒一下，我們今年早些時候停止了 ARC 10 的招募，以優先考慮正在進行的一線 3 期 dom 研究，即轉移性非小細胞肺癌的 STAR-121 和上消化道癌症的 STAR-221。

Moving to slide 22, and on behalf of Cindy and the Kite team, we are excited to share updates at the upcoming ASH Congress, including our Phase 2 iMMagine-1 results, for anito-cel in fourth line or later relapsed or refractory multiple myeloma.

前往投影片22，我們代表Cindy 和Kite 團隊，很高興在即將召開的ASH 大會上分享最新進展，包括我們的2 期iMMaine-1 結果，用於anito-cel 治療第四線或後來的複發或難治性多發性骨髓瘤。

The ASH abstract shared yesterday reflects 58 patients who received anito-cel with median follow-up of 10.3 months as of the June 2024 cut off.

昨天分享的 ASH 摘要反映了 58 名接受 anito-cel 治療的患者，截至 2024 年 6 月，中位追蹤時間為 10.3 個月。

Treatment with anito-cel demonstrated deep and durable efficacy with an objective response rate of 95% and a complete response rate of 62%.

anito-cel 治療顯示出深度和持久的療效，客觀緩解率為 95%，完全緩解率為 62%。

Of those are valuable for MRD testing, 92% achieved MRD negativity.

其中對 MRD 檢測有價值的人中，92% 的 MRD 呈陰性。

The median progression free survival and overall survival had not yet been reached.

中位無惡化存活期和總存活期尚未達到。

Additionally, Arcellx announced yesterday that updated data from the Phase 1 study will be presented at ASH.

此外，Arcellx 昨天宣布，第一階段研究的最新數據將在 ASH 上公佈。

In the meantime, Arcellx has already shared that an even later data cut from Phase 1 has shown that anito-cel achieved a 30.2 month median progression-free survival and median overall survival was not yet reached.

同時，Arcellx 已經透露，第一階段的更晚數據顯示 anito-cel 實現了 30.2 個月的中位無惡化存活期，但尚未達到中位總存活期。

In summary, we're encouraged by the compelling results so far, and with over 140 patients dosed across both the Phase 1 and Phase 2 iMMagine-1 studies, we have not yet seen any cases of delayed neurotoxicities.

總而言之，我們對迄今為止令人信服的結果感到鼓舞，並且在 1 期和 2 期 iMMaine-1 研究中，有超過 140 名患者接受了給藥，我們尚未看到任何遲發性神經毒性的病例。

This includes no parkinsonism, no cranial nerve palsies, and no Guillain-Barre syndrome.

這包括沒有帕金森氏症、沒有顱神經麻痺和沒有吉蘭巴利症候群。

We'll be sharing updated data at the ASH conference and look forward to potentially offering anito-cel's best-in-class profile to these late-stage multiple myeloma patients.

我們將在 ASH 會議上分享最新數據，並期待為這些晚期多發性骨髓瘤患者提供 anito-cel 的一流數據。

Separately, we're pleased FDA has granted Kite the regenerative medicine advanced therapy designation or RMAT for the evaluation of Yescarta for newly diagnosed, high-risk large B cell lymphoma who have a positive pet scan after two cycles of first line chemotherapy.

另外，我們很高興 FDA 授予 Kite 再生醫學先進療法稱號或 RMAT，用於評估 Yescarta 治療新診斷的高風險大 B 細胞淋巴瘤，這些患者在兩個週期的一線化療後寵物掃描呈陽性。

Under the RMAT designation, the Yescarta development program for first line treatment of high-risk large B cell lymphoma will be able to access the benefits of the FDA's accelerated pathways, including fast track and breakthrough designations.

根據 RMAT 指定，用於高風險大 B 細胞淋巴瘤一線治療的 Yescarta 開發項目將能夠獲得 FDA 加速途徑的好處，包括快速通道和突破性指定。

Our Phase 3 ZUMA-23 study in this setting is ongoing and we look forward to sharing updates in due course.

我們在此背景下的第 3 階段 ZUMA-23 研究正在進行中，我們期待在適當的時候分享更新。

Moving to our milestones on slide 23, a brief update on ASCENT-03.

前往投影片 23 上的里程碑，這是 ASCENT-03 的簡短更新。

As a reminder, this is an event-driven trial and I can share that we are continuing to accrue events at this time.

提醒一下，這是一個事件驅動的試驗，我可以分享的是，我們目前正在繼續累積事件。

With that in mind, it is possible we will not reach data cut off this year and we look forward to updating you in due course.

考慮到這一點，今年我們可能不會達到數據截止的狀態，我們期待在適當的時候向您通報最新情況。

Other updates this quarter included the readout of PURPOSE 2 data ahead of schedule, the review of our Phase 2 data for lenacapavir plus our broadly neutralizing antibodies with plans to share the data at an upcoming scientific conference in 2025, the initiation of several key HIV Trodelvy and cell therapy trials, including enrollment for ISLEND-1, ISLEND-2, ASCENT-GYN-01, and iMMagine-3.

本季的其他更新包括提前讀出目的2 數據、審查我們的lenacapavi 加上我們的廣泛中和抗體的2 期數據，併計劃在2025 年即將舉行的科學會議上分享數據、啟動幾項關鍵的HIV Trodelvy細胞治療試驗，包括 ISLEND-1、ISLEND-2、ASCENT-GYN-01 和 iMMaine-3 的入組。

In closing.

結束時。

I'd like to thank the Kite and Gilead research and development teams for stellar quarter of execution.

我要感謝 Kite 和吉利德研發團隊在本季的出色執行。

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

這樣，我就把電話轉給安迪。

Thank you, Merdad, and good afternoon, everyone.

謝謝你，默達，大家午安。

Our third quarter results represent a strong quarter for Gilead, as shown on slide 25, with our base business up 7% year over year to $6.8 billion driven by growth in each of our core businesses.

如投影片 25 所示，我們的第三季業績代表了吉利德的強勁季度業績，在每項核心業務成長的推動下，我們的基礎業務年增 7%，達到 68 億美元。

Veklury also delivered substantial growth resulting in total product sales up 7% year over year to $7.5 billion.

Veklury 也實現了大幅成長，產品總銷售額年增 7%，達到 75 億美元。

Before moving to non-GAAP, I'll highlight the impairment charge that impacted our third-quarter financial results on a GAAP basis as noted on slide 26.

在轉向非 GAAP 之前，我將強調影響我們按 GAAP 計算的第三季財務表現的減損費用，如投影片 26 所示。

As a reminder, this relates to the carrying value of the IPR&D indefinite-lived intangible assets acquired from Immunomedics in 2020.

需要提醒的是，這與2020年從Immunomedics收購的IPR&D無限期無形資產的帳面價值有關。

During the third quarter, we decreased the fair value by $1.8 billion or $1.04 per share, net of tax impact, reflecting the removal of the second line non-small cell lung cancer indication.

在第三季度，扣除稅務影響後，我們將公允價值減少了 18 億美元，即每股 1.04 美元，反映出二線非小細胞肺癌適應症的取消。

The remaining $1.8 billion carrying value reflects Trodelvy's opportunity in the first line setting.

剩餘的 18 億美元帳面價值反映了 Trodelvy 在一線環境中的機會。

Note that the potential indications that we've begun to explore since the acquisition are not reflected in the carrying value such as endometrial or small cell lung cancer.

請注意，自收購以來我們開始探索的潛在跡象並未反映在帳面價值中，例如子宮內膜癌或小細胞肺癌。

Moving to our non-GAAP results for the third quarter on slide 27, product gross margin was 87%, up 84 basis points from last year, primarily due to product mix.

轉向幻燈片 27 上的第三季非 GAAP 業績，產品毛利率為 87%，比去年增長 84 個基點，這主要歸功於產品組合。

R&D expenses were down 5% year over year, primarily driven by timing of clinical activities such as the wind down of the magrolimab program and the obeldesivir oral COVID studies and supported by our broader expense management initiatives.

研發費用年減 5%，主要是由於 Magrolimab 計畫和奧貝昔韋口服新冠肺炎研究的結束等臨床活動時機的推動，以及我們更廣泛的費用管理舉措的支持。

Acquired IPR&D was $505 million, which reflects the $320 million buyout of global Livdelzi royalties from Janssen announced in August and the $35 million upfront expense to initiate a new AI partnership with Genesis, in addition to ongoing collaboration expenses.

收購的IPR&D 金額為5.05 億美元，其中包括8 月宣布的以3.2 億美元收購Janssen 的全球Livdelzi 特許權使用費，以及與Genesis 建立新的AI 合作夥伴關係的3500 萬美元的前期費用，以及持續的合作費用。

SG&A was up 8% year over year, primarily due to timing of commercial and corporate activities, including the launch of Livdelzi in the United States and other initiatives including pre-launch preparations for lenacapavir for PrEP.

SG&A 年成長 8%，主要是由於商業和企業活動的時機，包括在美國推出 Livdelzi 以及其他舉措，包括用於 PrEP 的lenacapavir 上市前準備工作。

Operating margin for the third quarter was 43%.

第三季營業利益率為 43%。

Excluding the impact of the royalty buyout charge from Janssen, operating margin would have been 47%.

排除楊森特許權使用費收購費用的影響，營業利益率為 47%。

While there will always be some quarterly variability, recent results demonstrate a consistent trend of our operating margin firmly in the 40%-plus range and we remain focused on being an industry leader in terms of operating margin.

雖然季度波動總是存在，但最近的結果表明，我們的營業利潤率始終保持在 40% 以上的穩定趨勢，並且我們仍然致力於成為營業利潤率的行業領導者。

Our effective tax rate was approximately 18% as compared to 7% in the same period last year.

我們的有效稅率約為 18%，而去年同期為 7%。

As a reminder, the tax rate in the third quarter of 2023 benefited from decreased tax reserves as a result of reaching an agreement with a tax authority on certain tax positions.

需要提醒的是，2023年第三季的稅率受益於與稅務機關就某些稅務狀況達成協議而導致的稅收儲備減少​​。

In total, non-GAAP diluted EPS was $2.02 per share as compared to $2.29 per share in the same period last year, primarily reflecting higher acquired IPR&D and tax expense, partially offset by higher product sales.

總體而言，非 GAAP 攤薄後每股收益為 2.02 美元，而去年同期為每股 2.29 美元，主要反映了收購的智慧財產權和研發費用和稅收費用的增加，部分被產品銷售額的增加所抵消。

As mentioned earlier, the $320 million expense related to buyout of global Livdelzi royalties from Janssen impacted our EPS by $0.20 per share.

如前所述，與楊森收購全球 Livdelzi 特許權使用費相關的 3.2 億美元費用影響了我們每股收益 0.20 美元。

As highlighted on slide 28, we had a strong first nine months of the year with solid performance in each of our core franchises across HIV, oncology, and liver disease, driving base business growth of 7% year over year with Veklury already exceeding our initial full-year guidance of $1.3 billion.

正如幻燈片28 所強調的那樣，我們今年前9 個月表現強勁，在愛滋病毒、腫瘤學和肝病領域的每個核心特許經營業務均表現穩健，推動基礎業務同比增長7%，其中Veklury 已經超過了我們最初的預期全年指引為 13 億美元。

Altogether, total product sales for the first nine months of 2024 were up 6% year over year.

整體而言，2024 年 9 個月的產品總銷售額年增 6%。

Moving to guidance on slide 29, we are updating much of our guidance to reflect the very strong performance in our business so far this year.

轉向幻燈片 29 上的指導，我們正在更新大部分指導，以反映今年迄今為止我們業務的強勁表現。

We are increasing our guidance for product sales, excluding Veklury, by $150 million at the midpoint from the prior range to a new range of $26 billion to $26.3 billion.

我們將產品銷售指引（不包括 Veklury）提高了 1.5 億美元，從先前範圍的中位數提高到 260 億至 263 億美元的新範圍。

In addition to our strong year-to-date performance, this guidance accounts for evolving competition in our cell therapy business.

除了我們今年迄今為止的強勁表現之外，該指南還說明了我們細胞治療業務中不斷變化的競爭。

The increased revenue guidance also reflects higher full-year expectations for HIV; now expected to grow approximately 5% from 2023 compared to our prior expectations of 4%.

收入指引的增加也反映出對愛滋病毒的全年預期更高；目前預計從 2023 年起將成長約 5%，而我們先前的預期為 4%。

This guidance implies that fourth-quarter HIV could be roughly flat, which we believe is prudent given the strength in the third quarter and the normal variability we can see with HIV pricing.

這項指引意味著第四季度的愛滋病毒可能大致持平，考慮到第三季度的強勁勢頭以及我們在愛滋病毒定價中可以看到的正常波動，我們認為這是謹慎的。

We expect full-year Veklury revenue to be approximately $1.8 billion.

我們預計 Veklury 全年營收約 18 億美元。

We, therefore, expect full-year 2024 total product sales in the range of $27.8 billion to $28.1 billion, an increase of $650 million at the midpoint compared to the prior range.

因此，我們預計 2024 年全年產品總銷售額將在 278 億美元至 281 億美元之間，比先前的範圍中位數增加 6.5 億美元。

Turning to the rest of the P&L on a non-GAAP basis.

轉向非公認會計準則基礎上損益表的其餘部分。

We expect product gross margin to be approximately 86% narrowed from our prior 85% to 86% range and reflecting year-to-date results as well as our expectations for a more favorable product mix in the fourth quarter.

我們預計產品毛利率約為 86%，從先前的 85% 縮小至 86%，反映了年初至今的業績以及我們對第四季更有利的產品組合的預期。

We now expect R&D expense to decline a low-single-digit percentage as compared to our prior outlook of low- to mid-single-digit growth, reflecting the discontinuation of certain programs and careful expense management.

與我們先前低至中個位數成長的預期相比，我們現在預期研發費用將下降低個位數百分比，反映出某些項目的終止和謹慎的費用管理。

And, there's no change to our prior expectations for both acquired IPR&D and SG&A.

而且，我們之前對收購的 IPR&D 和 SG&A 的預期沒有改變。

Reflecting these updates, we now expect operating income in the range of $8 billion to $8.3 billion, up from $7.2 billion to $7.6 billion previously.

根據這些更新，我們現在預計營業收入將在 80 億美元至 83 億美元之間，高於先前的 72 億美元至 76 億美元。

Full-year tax is expected to be approximately 27% slightly lower than our prior 30% guidance and reflecting the higher operating income for the full year as well as the negative impact from the one-time charge for the acquisition of CymaBay in the first quarter.

全年稅收預計約為 27%，略低於我們先前 30% 的指導，反映了全年較高的營業收入以及第一季度收購 CymaBay 的一次性費用的負面影響。

As a reminder, this compares to our initial guidance in February of approximately 19% prior to the CymaBay impact.

提醒一下，這與我們 2 月受到 CymaBay 影響之前的初步指引相比約為 19%。

Altogether, we've raised our earnings per share guidance to a range of $4.25 and $4.45. This compares to our prior guidance of $3.60 to $3.90 and reflects both revenue outperformance and continued operating expense discipline.

總的來說，我們將每股收益指引上調至 4.25 美元至 4.45 美元的範圍。這與我們之前 3.60 美元至 3.90 美元的指導相比，反映了收入表現出色和持續的營運費用紀律。

At the midpoint, our updated guidance represents an increase of $750 million in non-GAAP operating income and an increase of $0.60 in non-GAAP earnings per share.

在中點，我們更新的指引意味著非 GAAP 營業收入增加了 7.5 億美元，非 GAAP 每股收益增加了 0.60 美元。

On a GAAP basis, EPS is expected to be $0.05 to $0.25.

根據 GAAP 計算，每股收益預計為 0.05 美元至 0.25 美元。

Moving to slide 30, we returned $1.3 billion to shareholders in the third quarter and a total of $3.7 billion in the first nine months of the year.

轉向投影片 30，我們在第三季向股東返還了 13 億美元，今年前 9 個月總共向股東返還了 37 億美元。

Our capital allocation priorities remain unchanged with significant balance sheet flexibility.

我們的資本配置優先事項保持不變，資產負債表具有顯著的彈性。

Overall, Gilead is on track to deliver an extremely strong 2024 and we're particularly pleased with our progress on operating expense management, which we believe sets us up well as we enter 2025.

總體而言，吉利德預計在 2024 年實現極其強勁的業績，我們對營運費用管理的進展感到特別滿意，我們相信這將為我們進入 2025 年奠定良好的基礎。

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

現在，我將邀請麗貝卡開始問答。

(Operator Instructions) Courtney Breen, Bernstein.

（操作員說明）考特尼·布林，伯恩斯坦。

Hi, there.

你好呀。

Thank you so much for taking my question today.

非常感謝您今天回答我的問題。

I'm interested in talking a little bit about the CAR T space.

我有興趣談談 CAR T 空間。

Specifically, can you help to dimensionalize the in-class versus out-of-class impacts on your start of this quarter.

具體來說，您能否幫助量化本季初課堂內和課外的影響？

Particularly, as we think about Breyanzi and whether these results establish any need to pivot the focus of the commercial strategy that you outlined in the in the presentation today.

特別是，當我們思考 Breyanzi 以及這些結果是否表明有必要將您在今天的簡報中概述的商業策略的重點轉向時。

Thanks, Courtney.

謝謝，考特尼。

So we have Cindy Perettie here.

辛蒂·佩雷蒂也來了。

I'll turn over to her to respond.

我會轉交給她回應。

Thanks, Courtney, for your question.

謝謝考特尼提出的問題。

So if I look at the in-class competition that we face this quarter, it boils down to two things.

因此，如果我看看我們本季面臨的課堂競爭，可以歸結為兩件事。

One is our two new indications, both in follicular lymphoma and mantle cell lymphoma.

一是我們的兩個新適應症，即濾泡性淋巴瘤和套細胞淋巴瘤。

And the second is an increase in capacity within manufacturing.

第二是製造業產能的增加。

So that's the in-class space that we're facing.

這就是我們面臨的教室空間。

Out of class, we continue to face competition through bispecifics, and I would put them probably at about 50/50 on what we're seeing today.

課外，我們繼續面臨雙特異性的競爭，我認為它們與我們今天所看到的情況的比例可能約為 50/50。

From our strategy standpoint, we do not believe we have to pivot.

從我們的策略角度來看，我們認為我們不必轉向。

I think, in the oncology space, when new therapies get approved and new indications, it's very common for physicians to try out the new therapies.

我認為，在腫瘤學領域，當新療法獲得批准和新適應症時，醫生嘗試新療法是很常見的。

And we expect to see that.

我們希望看到這一點。

And we've seen that both with in-class and out-of-class competitors.

我們在同級和同級競爭對手中都看到了這一點。

We're continuing to focus on driving both our class share and our brand share and feel very confident in the plans that we have to date to continue our expansion into the community and elsewhere and feel confident that we're going to build on our leadership both for Yescarta and Tecartus, but also recognizing as we look ahead, anito-cel will be coming in 2026.

我們將繼續專注於提高我們的班級份額和品牌份額，並對我們迄今為止繼續向社區和其他地方擴張的計劃充滿信心，並對我們將鞏固我們的領導地位充滿信心Yescarta 和Tecartus 都如此，但我們也體認到，展望未來，anito-cel 將於2026 年推出。

Mike Yee, Jefferies.

麥克葉，杰弗里斯。

Great.

偉大的。

Thanks.

謝謝。

Congrats on a great quarter.

恭喜您度過了一個出色的季度。

Thinking about lenacapavir for PrEP, based on feedback from docs, we're hearing that there could be a good market and good adoption for swapping from a current Descovy.

考慮將 Lenacapavir 用於 PrEP，根據文件的回饋，我們聽說，從目前的 Descovy 替換可能會有良好的市場和良好的採用。

Can you just talk a little bit about how you're thinking about the launch of lenacapavir for PrEP next year?

您能否簡單談談您對明年推出用於 PrEP 的 Lenacapavi 的看法？

Could that be a fast launch?

這可能是快速啟動嗎？

And think about the dynamics there, is it buy and build?

想想那裡的動態，是購買和建造嗎？

So, can you talk a little bit about how well you think that could launch and where the opportunity is?

那麼，您能談談您認為該專案的啟動效果如何以及機會在哪裡嗎？

Thanks.

謝謝。

Thanks, Mike.

謝謝，麥克。

We've got Johanna here.

約翰娜在這裡。

So I'll let her take that question.

所以我會讓她回答這個問題。

Thanks for the question.

謝謝你的提問。

Yeah, I think we're very excited about the potential launch for lenacapavir for PrEP.

是的，我認為我們對用於 PrEP 的 lenacapavi 的潛在推出感到非常興奮。

The growth opportunities are clear for us, right?

成長機會對我們來說很明顯，對吧？

It's around market size growth when you think about more consumers using PrEP, more prescribers prescribing it, so more physician based, and then, of course, more countries because thus far it's really been very US focused.

當你想到更多的消費者使用PrEP、更多的處方者開處方、更多的以醫生為基礎，當然還有更多的國家，因為到目前為止它確實非常關注美國時，這與市場規模的成長有關。

We do think there's a real expansion just in the consumers when you think about -- right now, the market is primarily white MSMs.

我們確實認為，當你考慮一下時，消費者群體確實在擴大——目前，市場主要是白人男男性接觸者。

We think there's a real opportunity to expand that to include Black, Latino individuals, young adults, cisgender women, transgender.

我們認為，確實有機會將其範圍擴大到黑人、拉丁裔、年輕人、順性別女性、跨性別者。

So there's a lot there, let alone prescribers.

所以那裡有很多東西，更不用說處方者了。

Right now, the prescribers we have are currently the ones that prescribe generally speaking for HIV treatment.

目前，我們的處方醫生通常都是開立愛滋病毒治療處方的醫生。

And we think the market can be expanded much more broadly than that.

我們認為市場可以擴大得更廣泛。

And then of course, countries.

當然，還有國家。

And as I was mentioning, I do think there's real opportunities when you think about lenacapavir for PrEP and the profile that it offers is quite differentiated.

正如我所提到的，我確實認為當您考慮用於 PrEP 的 lenacapavi 時，確實存在真正的機會，並且它提供的特性非常獨特。

And from a market share growth, I think it'll be mixed.

從市場佔有率的成長來看，我認為情況會好壞參半。

I think you're right.

我認為你是對的。

I think lenacapavir twice-yearly subcu profile offers a lot for people looking for HIV prevention who may want or need it.

我認為，lenacapavir 每年兩次的 subcu 分析為那些可能想要或需要它的尋求 HIV 預防的人提供了很多幫助。

And I do think it will have some impact on both Descovy from a daily-oral standpoint, but also 55% of the market is actually generic oral.

我確實認為，從日常口服藥的角度來看，這會對 Descovy 產生一些影響，而且 55% 的市場實際上是非專利口服藥。

And I do think it's going to have a big impact across the whole daily-oral market to see lenacapavir come in.

我確實認為萊那卡韋的出現將對整個日常口服市場產生巨大影響。

After your question about how quickly we can do that, I mean, the plans for commercialization are well underway.

在你問我們能多快做到這一點之後，我的意思是，商業化計畫正在順利進行中。

We are thinking through how do we make sure we make this a seamless experience for all of our customers, so that includes providers when they prescribe lenacapavir but also for consumers to make sure they have access to lenacapavir.

我們正在思考如何確保為所有客戶提供無縫體驗，其中包括開立倫那帕韋處方的供應商，也包括消費者確保他們能夠獲得倫那帕韋。

And that's looking at our distribution system, our reimbursement, and making sure that we just provide that seamless experience for all.

這就是我們的分銷系統、我們的報銷，並確保我們為所有人提供無縫的體驗。

So more to come on that.

所以還有更多的事情要做。

We have the HIV analyst event coming up in December, and we'll be able to share a little bit more data there.

我們將在 12 月舉辦 HIV 分析師活動，我們將能夠在那裡分享更多的數據。

But definitely, an opportunity for us to grow overall Gilead share in the prevention market, both with Descovy for those who prefer daily oral.

但毫無疑問，這對我們來說是一個增加吉利德在預防市場整體份額的機會，無論是對於那些喜歡每日口服的人來說，都是與 Descovy 一起使用。

But obviously, the growth is really going to come from lenacapavir for prevention.

但顯然，成長實際上將來自用於預防的萊那卡韋。

Umer Raffat, Evercore.

烏默·拉法特，Evercore。

Hi guys.

嗨，大家好。

Thanks for taking my question.

感謝您提出我的問題。

I wanted to focus on anito-cel and delayed neurotox for a quick second.

我想快速關註一下 anito-cel 和延遲神經毒素。

And it's a two-part question.

這是一個由兩部分組成的問題。

First, I'm just curious, do you think is it the construct or the trial design or any other reason which explains the lack of delayed neurotox, GBS, et cetera?

首先，我只是很好奇，你認為是結構、試驗設計還是任何其他原因解釋了遲發性神經毒素、GBS 等的缺乏？

And secondly, do you think we now have sufficient data from the existing data sets in Phase 1 to rule out any delayed neurotox when the sample size expands to 500 to 1,000 patients in Phase 3 trials?

其次，您認為當第 3 階段試驗的樣本量擴大到 500 至 1,000 名患者時，我們現在從第 1 階段的現有數據集中獲得了足夠的數據來排除任何延遲的神經毒素嗎？

Thank you very much.

非常感謝。

Sure.

當然。

Thank you, Umer.

謝謝你，烏梅爾。

So your question about our perspective on whether it's the construct of the trial design that relates to the delayed neurotoxicity that we haven't observed.

因此，您提出的問題是我們對試驗設計的結構是否與我們尚未觀察到的遲發性神經毒性有關的看法。

We believe it's the construct.

我們相信這是構造。

As a reminder, we have a very compact DD domain and we think that, that is a big piece of why we aren't seeing the delayed neurotox and are continuing to look at our translational medicine group to uncover sort of pieces of that.

提醒一下，我們有一個非常緊湊的 DD 域，我們認為這是我們沒有看到延遲神經毒素的一個重要原因，並且我們正在繼續關注我們的轉化醫學小組以發現其中的一些部分。

But we're having increasing confidence that it's the construct.

但我們越來越相信它是建構出來的。

I think the second piece that you asked is, do we have sufficient data?

我想你問的第二個問題是，我們有足夠的數據嗎？

Look, we're at 100 patients' worth of data between the Phase 1 of 38 patients and what we just shared in the ASH abstract.

看，我們有 100 名患者的 1 期數據，其中包括 38 名患者，以及我們剛剛在 ASH 摘要中分享的數據。

Coming forward to ASH, we're going to have a larger data set.

展望 ASH，我們將擁有更大的資料集。

We've done another data cut that we're cleaning now that we'll be presenting at ASH.

我們已經完成了另一項資料切割，現在正在清理，並將在 ASH 上展示。

So having that confidence of over 100 patients to date and not observing the neurotoxicity makes us recognize that we have a best-in-class construct.

因此，迄今為止超過 100 名患者的信心使我們認識到我們擁有一流的結構。

And we're really looking forward to sharing that data at ASH.

我們非常期待在 ASH 上分享這些數據。

Tyler Van Buren, TD Cowen.

泰勒·範布倫，TD·考恩。

Hey, guys.

嘿，夥計們。

Good afternoon.

午安.

Congratulations on the results.

祝賀結果。

Just had another one on anito-cel since the data reported yesterday were very exciting.

由於昨天報告的數據非常令人興奮，剛剛又收到了一份關於 anito-cel 的報告。

So with the expectation to be on the market in 2026, can you talk about the ability to scale the product upon launch?

那麼，預計 2026 年上市，您能談談產品推出後擴充的能力嗎？

And to be more specific, is the manufacturing process similar enough to Yescarta and Tecartus, where the FDA will allow you to scale manufacturing at a faster pace or will anito-cel have to scale at the same initial pace that Yescatra and Tecartus did?

更具體地說，製造過程是否與 Yescarta 和 Tecartus 足夠相似，FDA 將允許您以更快的速度擴大生產規模，還是 anito-cel 必須以與 Yescatra 和 Tecartus 相同的初始速度擴大規模？

Yeah.

是的。

So we have taken all of our learnings from Yescatra and Tecartus and applied that to the anito-cel production.

因此，我們從 Yescatra 和 Tecartus 汲取了所有經驗，並將其應用到 anito-cel 生產中。

And as we shared, last quarter, we have done the full tech transfer into our Maryland facility.

正如我們所分享的，上個季度，我們已將全部技術轉移到我們的馬裡蘭州工廠。

And we're producing anito-cel for iMMagine-3 study, where we have successfully dosed two patients now.

我們正在為 iMMagine-3 研究生產 anito-cel，目前我們已成功對兩名患者進行了給藥。

And our turnaround times are looking very similar to our commercial products that we have today, again, having applied all those learning.

我們的周轉時間看起來與我們今天擁有的商業產品非常相似，再次應用了所有這些知識。

So we don't have any concerns about our ability to scale.

因此，我們對我們的擴展能力沒有任何擔憂。

We've also not had feedback from the FDA that we would have to use the same approach as other competitors in this space.

我們也沒有收到 FDA 的回饋，表明我們必須使用與該領域其他競爭對手相同的方法。

Mohit, Wells Fargo.

莫希特，富國銀行。

Hi, this is Sadiya on from Mohit.

大家好，我是來自 Mohit 的 Sadiya。

Thanks for taking our question.

感謝您提出我們的問題。

Maybe one on seladelpar.

也許是 seladelpar 上的一個。

Could you share any early insights, especially regarding pair coverage into this launch, given that the other PPAR agonist is priced at a slight discount to seladelpar?

鑑於另一種 PPAR 激動劑的定價比 seladelpar 稍有折扣，您能否分享一些早期見解，尤其是關於本次上市的配對報道？

Do you see this impacting PPAR preferences between these two options?

您認為這會影響這兩個選項之間的 PPAR 偏好嗎？

Thank you.

謝謝。

Sure.

當然。

I'll take that one.

我會接受那個。

Johanna.

約翰娜。

So we're really quite pleased with our initial launch.

所以我們對最初的發布感到非常滿意。

So it's only been a few months.

所以才過了幾個月。

We launched mid-August, but so far, we've exceeded our internal expectations for patient demand.

我們在八月中旬推出，但到目前為止，我們已經超越了我們對患者需求的內部預期。

And I just want to take a moment and then I'll address your payer coverage question specifically.

我只想花一點時間，然後我將具體解決您的付款人承保問題。

I’m just really pleased and proud of the cross functional team that's come together so quickly.

我對跨職能團隊如此迅速地聚集在一起感到非常高興和自豪。

They were fully trained and mobilized within 24 hours of our approval.

他們在我們批准後 24 小時內就接受了全面培訓並動員起來。

And we had our first script within hours of the approval from the FDA.

在獲得 FDA 批准後的幾個小時內，我們就完成了第一個腳本。

We've reached over 1,000 of our key targets in the first 2.5 weeks post launch.

在發布後的前 2.5 週內，我們已經實現了 1,000 多個關鍵目標。

And obviously, you can appreciate that our history in liver disease and our credibility here really opens the doors for the access to these key stakeholders for PBC, which really obviously is critical as you think about early launch dynamics.

顯然，您可以體會到我們在肝病方面的歷史和我們在這裡的信譽確​​實為 PBC 接觸這些主要利益相關者打開了大門，當您考慮早期發布動態時，這顯然至關重要。

And so we're very excited about that.

我們對此感到非常興奮。

We also took a very clear strategy when it came to what we were looking for reimbursement but also distribution.

當談到我們尋求報銷和分配時，我們也採取了非常明確的策略。

And so from day one, we enabled direct purchasing with a specialty distributor, which was actually quite pivotal when you think about key academic centers.

因此，從第一天起，我們就啟用了專業經銷商的直接採購，當您考慮主要學術中心時，這實際上非常關鍵。

And if you think about the business, it's probably a mix about 50/50 or so between the academic centers and in the community.

如果你考慮一下業務，學術中心和社區之間的比例可能大約是 50/50。

The coverage so far with payers is very much in line with their expectations for rare disease.

迄今為止，付款人的承保範圍非常符合他們對罕見疾病的預期。

And we're really quite encouraged to see that no major barriers are happening, actually get access to Livdelzi outside of the typical ones that happen.

我們真的很高興看到沒有重大障礙，實際上可以在發生的典型障礙之外進入 Livdelzi。

But really for appropriate patients, it takes a little bit more time because we have to get through the step edits in the prior off, but we are getting through and patients are having access to seladelpar and Livdelzi.

但實際上對於合適的患者來說，這需要更多的時間，因為我們必須完成先前的步驟編輯，但我們正在完成，患者可以訪問 seladelpar 和 Livdelzi。

So we're excited and more to come as we think about 2024, but more importantly, as we ramp up into 2025, right?

因此，當我們展望 2024 年時，我們感到很興奮，更重要的是，當我們邁向 2025 年時，我們還會看到更多，對嗎？

We've always said it was a bit modest contribution in '24 with a more meaningful contribution to sales in 2025.

我們一直說，這對 24 年的貢獻有點不大，但對 2025 年的銷售貢獻更有意義。

So stay tuned.

所以請繼續關注。

Daina Graybosch, Leerink Partners.

戴娜‧格雷博斯 (Daina Graybosch)，Leerink 合夥人。

Hi, another one on anito-cel for me.

你好，我又來了一篇關於 anito-cel 的文章。

I wonder what's gating the regulatory filing and also what will be required to build the market for anito-cel in myeloma beyond the stubborn sort of 20% penetration you're hitting your heads against an NHL second line setting.

我想知道是什麼限制了監管備案，以及需要什麼來建立骨髓瘤中的 anito-cel 市場，超越你在 NHL 二線設定中遇到的頑固的 20% 滲透率。

Thanks a lot, Daina, for the question.

非常感謝戴娜提出這個問題。

So I think the components around the regulatory filing, as you're aware of what we've seen with others in the space is that they -- the FDA would be looking at 12 months’ worth of data, where this will be a filing discussion that we have with FDA.

因此，我認為監管備案的組成部分，正如您所知，我們在該領域的其他公司中看到的情況是，FDA 將查看 12 個月的數據，這將是我們與 FDA 進行的備案討論。

We do believe we have a very differentiated safety profile and we'll be talking to the agency about that review cycle based on that.

我們確實相信我們擁有非常差異化的安全概況，我們將在此基礎上與該機構討論審查週期。

The second question that you asked was around the -- today, only 2 out of the 10 patients receiving CAR T. We know, in multiple myeloma, it's 1 out of 10.

你問的第二個問題是－今天，每 10 名患者中只有 2 人接受 CAR T 治療。

So we have our work to do.

所以我們有我們的工作要做。

The work that we're putting towards the community practices and un-gating some of the reimbursement access challenges are the same challenges we will face whether it's lymphoma or multiple myeloma.

我們為社區實踐所做的工作以及消除一些報銷挑戰的挑戰與我們將面臨的挑戰相同，無論是淋巴瘤還是多發性骨髓瘤。

So all of the applications we're putting forward in our plan today will apply to anito-cel.

因此，我們今天在計劃中提出的所有應用都將適用於 anito-cel。

And that's why it's really critical as we execute over the next 12 to 18 months because we're really excited to bring anito-cel to more patients.

這就是為什麼我們在接下來的 12 到 18 個月內執行這項任務非常重要，因為我們非常高興能夠將 anito-cel 帶給更多患者。

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

Thank you.

謝謝。

Good afternoon.

午安.

Thanks for taking the question.

感謝您提出問題。

Love all the anito-cel questions, but I'm going to bring it back to HIV.

我喜歡所有的 anito-cel 問題，但我要把它帶回愛滋病毒。

I'm not sure who wants to take the question, but how should investors maybe gauge expectations of what we're going to hear at the analyst event.

我不確定誰願意回答這個問題，但投資者應該如何評估我們在分析師活動中將聽到的內容的預期。

Should we expect an explicit peak sales target for lenacapavir and PrEP or how you think about the long -- maybe a long-term treatment market objective or should we expect more of the qualitative market color that maybe Johanna referenced earlier?

我們是否應該期待萊那卡韋和 PrEP 的明確峰值銷售目標，或者您如何看待長期——也許是長期治療市場目標，或者我們應該期待更多約翰娜之前提到的定性市場色彩？

Thank you.

謝謝。

Thanks, Carter.

謝謝，卡特。

This is Dan.

這是丹.

So, first of all, we really look forward to hosting as many of you as possible at our HIV analyst event in December.

因此，首先，我們非常期待在 12 月的 HIV 分析師活動中接待盡可能多的人。

And our intention is to start sharing some more of our plans on the commercialization for lenacapavir with PrEP.

我們的目的是開始分享更多關於 Lenacapavi 與 PrEP 商業化的計劃。

Johanna has started to outline that on our quarterly calls, but we really need some more time to dimensionalize that market to begin to discuss how we will approach different aspects of the lenacapavir for PrEP market.

約翰娜已經開始在我們的季度電話會議上概述這一點，但我們確實需要更多時間來確定該市場的規模，以開始討論我們將如何處理 PrEP 市場的來那卡韋的不同方面。

I think, you can expect to be qualitative but also quantitative from the opportunity.

我認為，您可以從機會中獲得定性和定量的結果。

I think to your point about peak sales and things, that would come more into our guidance, that would be -- that would come more at the beginning of next year in terms of how we might see 2025 and beyond.

我認為，就您對高峰銷售和其他事項的觀點而言，這將更多地納入我們的指導中，即——就我們如何看待2025 年及以後的情況而言，這將在明年初更多地出現。

But in addition to the commercialization, we're going to spend a lot of time on highlighting the progress of our long-acting treatment combinations.

但除了商業化之外，我們還將花費大量時間來強調我們的長效治療組合的進展。

Merdad covered this in some of the prepared remarks, but we intend to bring you into even more detail about the progress of our long-acting treatment combinations.

Merdad 在一些準備好的發言中對此進行了介紹，但我們打算向您介紹我們長效治療組合的進展的更多細節。

In addition to what we've already disclosed, so we will have some new disclosures there.

除了我們已經披露的內容之外，我們還將披露一些新的內容。

We'll also be able to share our perspective on how we see the treatment market evolving in the coming years.

我們也將能夠分享我們對未來幾年治療市場發展的看法。

And I think that's an area of tremendous strength in terms of our overall program, as we're processing a variety of long acting treatment programs in parallel to make sure that we have multiple options for patients from longer-acting orals to longer-acting injectables.

我認為就我們的整體計劃而言，這是一個具有巨大優勢的領域，因為我們正在並行處理各種長效治療計劃，以確保我們為患者提供從長效口服藥物到長效注射藥物的多種選擇。

And you can expect to get an update on the R&D progress of those and some further update on timelines as we move forward.

隨著我們的進展，您可以期待獲得這些研發進展的最新資訊以及時間表的進一步更新。

Again, just to remind you, of course, the totality of our HIV business is such that we really don't have any significant patent expertise until Biktarvy in 2033.

當然，再次提醒您，我們的 HIV 業務整體如此，直到 2033 年 Biktarvy 推出之前，我們確實沒有任何重要的專利專業知識。

And really by that time, we will not only have the land for PrEP unfolding over that period of time but significant progress with potentially for new modalities for long-acting treatment even before 2033.

事實上，到那時，我們不僅會在這段時間內為 PrEP 鋪平道路，而且甚至在 2033 年之前就可能會出現長效治療新模式的重大進展。

So the intention is to really pull through and to show you the durability of our HIV business well into the late 2030s.

因此，我們的目的是真正渡過難關，並向您展示我們的愛滋病毒業務在 2030 年代末的持久性。

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

Good evening.

晚安.

Thanks for taking our questions.

感謝您回答我們的問題。

This is Chris on for Terence.

這是克里斯替補特倫斯。

Just one question for Andy.

只是問安迪一個問題。

Are you confident that you can drive operating margin expansion in 2025 on an ex-IPR&D basis?

您是否有信心在 2025 年推動不計智慧財產權和研發費用的營業利潤率擴張？

Thank you.

謝謝。

Hey, Chris.

嘿，克里斯。

It's Andy.

是安迪。

Thanks for the question.

謝謝你的提問。

We'll provide more specific guidance on 2025, of course, on our year end call.

當然，我們將在年終電話會議上提供 2025 年更具體的指導。

What we said though consistently and you see in the last two quarters is real progress in terms of letting the operating margin expand again as we now kind of enter a new phase of having now built the portfolio, executing both clinically and commercially, and really focusing on expense management.

我們所說的雖然一致，但你在過去兩個季度中看到的是，在讓營業利潤率再次擴大方面取得了真正的進展，因為我們現在進入了一個新階段，即建立投資組合，在臨床和商業上執行，並真正專注於關於費用管理。

You see the strong operating margin both in the second quarter and the third quarter.

您可以看到第二季和第三季的強勁營業利潤率。

Again, you heard in my prepared remarks that the operating margin would have been 47% this quarter, if you back out the impact of the royalty purchase from Janssen on seladelpar.

同樣，您在我準備好的演講中聽說，如果您排除從 Janssen 購買特許權使用費對 seladelpar 的影響，本季度的營業利潤率將為 47%。

So we're off to a great start.

所以我們有了一個好的開始。

Our ambition and expectation is that we will have an industry-leading operating margin over time.

我們的雄心和期望是，隨著時間的推移，我們將擁有行業領先的營業利潤率。

So again, it's too early to give any specific guidance on 2025.

因此，現在就 2025 年給出任何具體指導還為時過早。

More to come.

未來還會有更多。

But we're really pleased with where we are and the progress that you've seen in the last couple quarters.

但我們對我們的現狀以及您在過去幾季所看到的進展感到非常滿意。

And we're already in a very strong spot, and we'll continue to work to improve it over time.

我們已經處於非常有利的位置，隨著時間的推移，我們將繼續努力改進它。

Chris Schott, JP Morgan.

克里斯‧肖特，摩根大通。

Great.

偉大的。

Thanks so much.

非常感謝。

Just another HIV question on combos.

這只是關於組合的另一個愛滋病毒問題。

I think we got a number of lenacapavir combos in development.

我認為我們正在開發一些來那帕韋組合藥物。

I guess, I'm just trying to get my hands around when you think about the portfolio, where do you see subcu injectables playing in the treatment market relative to some of your weekly oral options?

我想，當您考慮產品組合時，我只是想了解一下，相對於您每週的一些口服選擇，您認為 subcu 注射劑在治療市場中發揮著怎樣的作用？

If I looked at that chart, it seemed like a lot of the programs by 2030 in the bNAbs were on the oral side.

如果我看一下這張圖表，到 2030 年，bNAb 中的許多項目似乎都是口服的。

So I was just trying to get a sense of like how important is that subcu-injectable there.

所以我只是想了解皮下注射有多重要。

Or do you see this mostly a longer-acting oral opportunity for the company?

或者您認為這對公司來說主要是長期有效的口頭機會？

Thank you.

謝謝。

Merdad.

梅達德。

So Merdad is here, Chris.

默達在這裡，克里斯。

We'll let him answer that, please.

我們會讓他回答這個問題，拜託。

Hi, Chris.

嗨，克里斯。

The way we're approaching this is really to take a very broad approach.

我們解決這個問題的方法實際上是採取非常廣泛的方法。

With the success with lenacapavir so far and what we've seen, we think that really forms a great foundation for us.

到目前為止，來那卡韋的成功以及我們所看到的一切，我們認為這確實為我們奠定了良好的基礎。

And we believe that there is enough demand in both the oral and the injectable areas for us to be developing in both.

我們相信口服和注射領域都有足夠的需求，我們可以在這兩個領域中發展。

So to your point, we really do see an opportunity for PrEP on the oral side for us to provide either weekly or monthly options, potentially also then going into the treatment market farther down the road and in subcutaneous.

因此，就您的觀點而言，我們確實看到了口服 PrEP 的機會，我們可以提供每週或每月的選擇，然後也可能進入更遠的皮下治療市場。

And the key differentiator being the durability of the treatment.

關鍵的差異在於治療的持久性。

So on the oral side, weekly to monthly.

所以在口頭方面，每周到每月。

On the injectable side, we think we can get to every three months, and hopefully, even up to every six months and beyond.

在註射方面，我們認為我們可以每三個月注射一次，希望甚至可以達到每六個月一次或更長時間。

So I think that's the key differentiator for us in terms of how we think about the opportunity.

所以我認為，就我們如何看待機會而言，這是我們的關鍵區別。

And of course, different people will be looking for different approaches and our goal -- our aim is to provide those options for them.

當然，不同的人會尋找不同的方法，而我們的目標是為他們提供這些選擇。

Yeah, maybe just to add to Merdad's comments, our approach is truly patient-centric.

是的，也許只是為了補充 Merdad 的評論，我們的方法確實是以患者為中心的。

The opportunity is just to make sure that we answer and address the needs.

這個機會只是為了確保我們滿足並滿足需求。

And the needs have been mixed.

而且需求是混合的。

I think there are some that really do prefer to be reminded and can take an oral pill only and don't want an injectable and others don't really want to think about HIV if they don't have to and if they can take for injections a year, that could do it as well or two even as to Merdad's comments as well.

我認為有些人確實更願意被提醒，並且只能服用口服藥，而不想要注射劑，而另一些人則真的不想考慮愛滋病毒，如果他們不需要的話，如果他們可以服用的話一年註射一次，這可能和梅達德的評論一樣好或兩次。

So more to come on that as to what we're doing.

關於我們正在做的事情還有更多內容。

But the intent is truly, we're leaders today in HIV, both across treatment and prevention.

但我們的真正目的是，我們是當今愛滋病毒治療和預防領域的領導者。

The intent is to continue to remain leaders for the future.

目的是在未來繼續保持領先地位。

And that's really with the pipeline that we have in our portfolio and the combinations that we have.

這實際上與我們的投資組合中的管道和組合有關。

So we're excited about the future and what it holds.

因此，我們對未來及其前景感到興奮。

And Chris, it's Andy.

克里斯，是安迪。

Maybe I just add one thing, the slide references, the products that we expect to have approved by 2030.

也許我只是添加一件事，幻燈片參考，我們預計到 2030 年批准的產品。

You should not read into that, that we don't expect these long-acting subcutaneous products to come to market even shortly after that.

您不應該對此進行解讀，我們預計這些長效皮下產品即使在不久之後也不會上市。

So we'll provide more guidance over time.

因此，隨著時間的推移，我們將提供更多指導。

Again, we'll talk more about the portfolio of our HIV day as Dan mentioned, but we were just focusing purely on that slide to the end of the decade.

再次，我們將更多地討論丹提到的愛滋病日的投資組合，但我們只是純粹關注到本世紀末的幻燈片。

It doesn't mean that we don't see a series of potential product launches beyond that as well.

這並不意味著我們不會看到除此之外的一系列潛在產品的發布。

So more to come.

未來還會有更多。

Thanks for the question.

謝謝你的提問。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Thank you.

謝謝。

So sorry about that.

對此感到非常抱歉。

Good afternoon.

午安.

So you've noted prior with regard to your long-acting HIV PrEP market that about 400,000 people are on PrEP today and that could increase to 600,000 by 2030.

因此，您之前已經注意到，關於長效 HIV PrEP 市場，目前約有 40 萬人在接受 PrEP，到 2030 年這一數字可能會增加到 60 萬人。

Is that still a fair assumption?

這仍然是一個公平的假設嗎？

And if so, where does this growth likely come from?

如果是這樣，這種增長可能來自哪裡？

And what do you view as a fair estimate for the portion of that 600,000?

您認為對這 60 萬人中的那一部分的合理估計是多少？

That'll prefer an oral option.

那會更喜歡口頭選擇。

Thank you.

謝謝。

Yes.

是的。

So Salveen, I'll try to address that one and you'll hear more about that actually, as we go into the HIV analyst event as well in early December.

Salveen，我將嘗試解決這個問題，當我們在 12 月初參加 HIV 分析師活動時，您實際上會聽到更多相關資訊。

But so we do believe that it's at least 600,000 by 2030.

但我們確實相信，到 2030 年，這個數字至少會達到 60 萬。

Now, this is a market in the past that we've really worked at through social media, direct to consumer, et cetera to really make sure we activate it, and that's how it's grown thus far the about 350,000 to 400,000 consumers today.

現在，這是一個過去我們真正透過社群媒體、直接面向消費者等方式開發的市場，以確保我們真正啟動它，這就是它迄今為止發展到今天約 350,000 至 400,000 名消費者的方式。

We think there's a real opportunity and most of the growth is going to come from different consumers to be honest.

我們認為這是一個真正的機會，說實話，大部分成長將來自不同的消費者。

So thus far the vast majority of consumers of HIV PrEP are white MSM.

到目前為止，絕大多數 HIV PrEP 消費者都是白人 MSM。

And so we think with PURPOSE 1, PURPOSE 2 and actually other PURPOSE studies to follow.

因此，我們認為目的 1、目的 2 以及實際上其他目的研究都可以遵循。

This is the broadest trial program that we've ever done in prevention or that's ever been done in prevention, and it includes many other consumers that I think really may need or even want prevention.

這是我們在預防方面做過的最廣泛的試驗計劃，它包括我認為真正可能需要甚至想要預防的許多其他消費者。

And that includes Latino, Black individuals, women, cisgender women, transgender, and then, even young adults, right?

這包括拉丁裔、黑人、女性、順性別女性、跨性別者，甚至是年輕人，對嗎？

And so a lot of that growth is going to come from there.

因此，大部分增長將來自那裡。

So could it be beyond the 600,000?

那麼會不會超過60萬呢？

Absolutely, 600,000.

絕對是60萬。

And we do think that most of that is going to be driven by a new option on the market and that is lenacapavir for prevention.

我們確實認為，其中大部分將由市場上的新選擇推動，那就是預防用的來那卡韋。

To have something that you don't need to think about when you're not ill to take every single day versus twice a year is a big differentiation, let alone with the data and efficacy that we've shown in both PURPOSE 1 and PURPOSE 2.

當您沒有生病時每天服用與每年服用兩次相比，您不需要考慮的東西是一個很大的區別，更不用說我們在目的 1 和目的中展示的數據和功效了2.

So more to come on that.

所以還有更多的事情要做。

I do think we have a lot of opportunities here, and the intent is to truly work on expanding this market for the future.

我確實認為我們這裡有很多機會，我們的目的是真正致力於擴大這個市場的未來。

I think it's not about thinking about what's currently in play today, but actually what it could be by 2030 with a little bit of investment and education and awareness.

我認為這不是要考慮目前正在發生的事情，而是要考慮透過一點投資、教育和意識，到 2030 年實際上會發生什麼。

Matt Biegler, Oppenheimer.

馬特·比格勒，奧本海默。

Great.

偉大的。

Thanks so much for the question.

非常感謝您的提問。

I had a question on ASCENT-03 with that coming up.

我有一個關於 ASCENT-03 的問題。

Can you just comment on how much larger you think that frontline opportunity is in triple negative breast cancer?

您能否評論一下您認為三陰性乳癌的第一線機會有多大？

Thanks.

謝謝。

Yes.

是的。

So as you move up earlier lines of therapy, obviously, it's as TNBC progresses, unfortunately, quite rapidly, the market is actually quite larger probably about just about double more.

因此，當你升級早期的治療方案時，很明顯，不幸的是，隨著 TNBC 的進展非常迅速，市場實際上相當大，可能大約是原來的兩倍。

And then of course, the split between PL-1 negative and PL-1 positive and that ASCENT-03 ASCENT-04.

當然，還有 PL-1 陰性和 PL-1 陽性之間的劃分以及 ASCENT-03 ASCENT-04。

That's a bit of a split as well, a little bit more on the negative and the positive in TNBC.

這也有一點分歧，TNBC 的消極和積極方面多了一點。

And so we do think with ASCENT-03 and then the future with ASCENT-04 moving up in earlier lines of therapy can really make a difference for these women if we can show overall survival in this setting as well.

因此，我們確實認為，如果我們也能在這種情況下顯示出整體存活率，那麼 ASCENT-03 以及未來 ASCENT-04 在早期治療中的進步確實可以為這些女性帶來改變。

I think that can be incredibly powerful for us as we've really established our place in second line plus as the standard of care, really, the opportunity would be to move up with those women to really make a difference earlier on in their metastatic disease.

我認為這對我們來說是非常強大的，因為我們已經真正確立了我們在二線的地位，並且作為護理標準，真的，機會將是與這些女性一起前進，在轉移性疾病的早期真正發揮作用。

Asthika Goonewardene, Truist.

Asthika Goonewardene，真理主義者。

Hi, this is Karina for Asthika.

大家好，我是 Asthika 的卡琳娜。

I had a couple of questions.

我有幾個問題。

You mentioned that you had three patients those on imagined free study, just wondering how many of the 130 clinical trial sites are current patients.

您提到您有 3 名患者正在進行想像中的免費研究，只是想知道 130 個臨床試驗地點中有多少是當前患者。

And another one is also you expect the anito-cel to be using outpatient settings since the time to answer the CRS was only two days and legend had previously mentioned that 45% of their patients are being used in outpatient setting.

另一個是你期望 anito-cel 使用門診環境，因為回答 CRS 的時間只有兩天，而且傳說之前提到他們 45% 的患者正在門診環境中使用。

So your thoughts on that as well?

那麼你對此也有想法嗎？

Thank you.

謝謝。

Yeah, we don't usually share the number of clinical sites that we have recruiting, but trust that the team is working hard to get all 130 up and going.

是的，我們通常不會透露我們招募的臨床中心的數量，但相信團隊正在努力讓所有 130 個臨床中心都正常運作。

You, you were asking a little bit about the outpatient profile.

你，你問了一些門診資料。

We believe that this therapy has an outpatient profile.

我們相信這種療法具有門診特徵。

You can tell just looking at the ICANS and CRS rates that we're seeing and we've actually designed that into our phase iMMagine-3 Phase 3 programs that we have data generated in that outpatient setting.

只需查看我們所看到的 ICANS 和 CRS 率，您就可以看出，我們實際上已將其設計到 iMMagine-3 第 3 階段計劃中，我們在門診環境中產生了數據。

As you talked about the onset, I think that's the component that, that we've designed into the trial.

當你談到發病時，我認為這就是我們在試驗中設計的組成部分。

Brian Abrahams, RBC Capital Markets.

布萊恩‧亞伯拉罕斯 (Brian Abrahams)，加拿大皇家銀行資本市場部。

Hi, thanks so much for taking my question.

您好，非常感謝您提出我的問題。

Given the potential for Medicaid cutbacks under a new administration, can you remind us around the degree of Medicaid exposure across your HIV franchise, and the mechanics of how access and reimbursement work for these patients with respect to a federal budget.

考慮到新政府可能會削減醫療補助，您能否提醒我們整個愛滋病毒特許經營機構的醫療補助暴露程度，以及這些病患在聯邦預算中如何獲得和報銷的機制。

And also how cuts such cuts might impact your outlook if at all?

如果有的話，這種削減可能會如何影響你的前景？

Thanks.

謝謝。

Sure.

當然。

So let me try to address that one, although I think there's still more to come, right?

因此，讓我嘗試解決這個問題，儘管我認為還有更多問題要做，對吧？

So we need a little bit more to see how this plays out for Medicaid specifically.

因此，我們需要更多的資訊來了解這對於醫療補助計劃的具體效果。

At this point in time, patients that are in HIV are always have a fallback position.

在這個時候，愛滋病毒感染者總是處於後備位置。

So if Medicaid is where we go, that's probably about mid- to high-20% of our total HIV business.

因此，如果醫療補助是我們的發展方向，那麼這可能占我們愛滋病毒業務總量的中到高 20%。

And that is a percentage of our business that we watch very closely.

這是我們密切關注的業務的一部分。

There's also an app that supports through the same system.

還有一個透過同一系統提供支援的應用程式。

So there are different ways to get access for patients in this setting, and honestly, what we're tracking more closely in the overall channel mix that we think about HIV is more the growth that we've seen in 340B settings, which also can impact the Medicaid patient population.

因此，在這種情況下，有不同的方法可以讓患者接觸到愛滋病病毒，老實說，我們在整個管道組合中更密切地追蹤的，我們認為愛滋病毒更多的是我們在340B 環境中看到的成長，這也可以影響醫療補助患者群體。

So from an access standpoint, it's never an issue to get HIV, there's different parachutes that are available for all of these patients, and we're going to watch very closely any Medicaid cut back.

因此，從獲取的角度來看，感染愛滋病毒從來都不是問題，所有這些患者都可以使用不同的降落傘，我們將密切關注醫療補助的任何削減。

At this point in time, but nothing has yet been announced.

目前，尚未宣布任何消息。

That completes the time that we have for questions.

我們提問的時間到此結束。

I'll invite Dan to share any closing remarks.

我將邀請丹分享任何結束語。

First of all, thank you all for joining.

首先，感謝大家的加入。

This has really been the strongest quarter for us of the year.

這確實是我們今年最強勁的季度。

The key highlights you've heard over the course of the discussion both commercially but also clinically the promise of our portfolio.

您在討論過程中聽到的主要亮點包括商業上和臨床上我們產品組合的承諾。

The remarkable PURPOSE 2 date on lenacapavir, the very encouraging initial launch of seladelpar and the data on anito-cel.

lenacapavir 引人注目的 PURPOSE 2 日期、非常令人鼓舞的 seladelpar 首次上市以及 anito-cel 的數據。

I just want you to know we're firmly focused as a team on strong commercial and clinical execution, we'll continue to prioritize resources, and we have a commitment to ongoing OpEx management.

我只是想讓您知道，作為一個團隊，我們堅定地專注於強大的商業和臨床執行力，我們將繼續優先考慮資源，並且我們致力於持續的營運支出管理。

I just flagged two things between now and the end of the year, that's obviously what we've spoken about, the HIV analyst event in December and also the upcoming presentation of anito-cel at ASH.

我剛剛標記了從現在到今年年底的兩件事，這顯然就是我們談論的內容，即 12 月的 HIV 分析師活動以及即將在 ASH 上進行的 anito-cel 演示。

And with that, I thank you for joining.

在此，我感謝您的加入。

I'll turn it over to Jacquie to close the call.

我會將其轉交給杰奎以結束通話。

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

謝謝丹，也謝謝大家加入我們。

Today, one final housekeeping item I can share that we are tentatively planning to release our fourth quarter and full year 2024 earnings results on February 11, 2025.

今天，我可以分享的最後一項管理事項是，我們暫定計劃於 2025 年 2 月 11 日發布 2024 年第四季和全年獲利結果。

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

請注意，該日期是暫定的，可能會進行更改，以適應從現在到那時之間出現的日程安排衝突。

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

像往常一樣，我們將在季度結束後宣布確認日期。

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

我們感謝您對吉利德的持續關注，並期待向您通報我們整個季度的進展。