吉利德科學 (GILD) 2022 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to Gilead Sciences Second Quarter 2022 Earnings Conference Call. (Operator Instructions) Please be advised that today's call is being recorded.

您好，感謝您的耐心等待。歡迎參加吉利德科學公司2022年第二季財報電話會議。 （操作說明）請注意，本次電話會議正在錄音。

I would now like to hand the conference over to Jacquie Ross, Vice President of Investor Relations. Please go ahead.

現在我將會議交給投資者關係副總裁傑奎·羅斯女士。請您開始吧。

Thank you, operator, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the second quarter of 2022. The press release, slides and supplemental data are available on the Investors section of our website at gilead.com.

謝謝接線員，大家下午好。今天收盤後，我們發布了2022年第二季財報。新聞稿、投影片和補充資料可在我們網站gilead.com的投資人關係欄位中查看。

The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day; our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Merdad Parsey; and our Chief Financial Officer, Andrew Dickinson. After that, we'll open up the call to Q&A where the team will be joined by Christi Shaw, the Chief Executive Officer of Kite.

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

Before we get started, let me remind you that we will be making forward-looking statements, including those related to the impact of the COVID-19 pandemic on Gilead's business; financial condition and results of operations; plans and expectations with respect to products, product candidates, corporate strategy, business and operations; financial projections and use of capital; and 2022 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

在開始之前，請允許我提醒各位，我們將做出一些前瞻性聲明，包括與 COVID-19 疫情對吉利德業務的影響；財務狀況和經營業績；有關產品、候選產品、公司戰略、業務和運營的計劃和預期；財務預測和資本使用；以及 2022 年財務指引相關的聲明。所有這些都涉及某些我們無法控制的假設、風險和不確定性，這些因素可能導致實際結果與這些聲明有重大差異。

A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

這些風險的詳細描述請參閱獲利新聞稿和我們最新的美國證券交易委員會（SEC）揭露文件。所有前瞻性陳述均基於吉利德目前掌握的信息，吉利德不承擔更新任何此類前瞻性陳述的義務。

Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet as well as on the Gilead website.

我們將使用非公認會計準則（Non-GAAP）財務指標來幫助您了解公司的基本業務表現。公認會計準則（GAAP）與非公認會計準則（Non-GAAP）的調節表已在獲利新聞稿、補充資料表以及吉利德公司網站上提供。

Now I'll turn the call over to Dan.

現在我把電話交給丹。

Thanks, Jacquie, and good afternoon, everybody. We really appreciate you joining today. We look forward to sharing our second quarter results, which highlighted a quarter of strong commercial and clinical execution. This was a very strong quarter for our business, delivering revenue of USD 6.1 billion. Excluding Veklury, total product sales grew 7% year-over-year.

謝謝Jacquie，大家下午好。非常感謝各位今天蒞臨。我們期待與大家分享第二季業績，本季我們在商業和臨床執行方面均表現出色。對於我們的業務而言，這是一個非常強勁的季度，營收達到61億美元。若不計入Veklury，產品總銷售額年增7%。

If we look at the underlying business and also exclude the impact of the HIV LOEs and the currency headwinds in the second quarter, growth was actually 11%. Our HIV portfolio continues to deliver, and this quarter was no exception with higher demand for both treatment and PrEP. Biktarvy sales grew by 28% year-over-year, and we expect to see continued market growth for treatment and prevention with the ongoing market recovery.

如果我們分析基本業務，並剔除第二季度愛滋病治療藥物延期交付和匯率波動的影響，實際成長率為11%。我們的愛滋病產品組合持續表現優異，本季也不例外，治療和暴露前預防（PrEP）的需求均有所成長。 Biktarvy的銷售額年增28%，我們預期隨著市場持續復甦，治療和預防市場將持續成長。

This was a record quarter for our oncology business. Revenues topped $0.5 billion for the first time with a strong contribution from Trodelvy and a standout performance by our cell therapies. Yescarta was approved by the FDA for second-line relapsed or refractory large B-cell lymphoma in April. This increased awareness and go demand not only for Yescarta's second-line patients but also for those in later lines of treatment. Yescarta is a potentially curative therapy, and Kite has uniquely and effectively scaled manufacturing to meet the needs of patients through the benefit.

本季是我們腫瘤業務創紀錄的季度。營收首次突破5億美元大關，主要得益於Trodelvy的強勁貢獻以及細胞療法的優異表現。今年4月，Yescarta獲FDA核准用於第二線治療復發或難治性大B細胞淋巴瘤。這不僅提高了人們對Yescarta的認知度和需求，也帶動了後續治療患者的需求。 Yescarta是一種潛在的治癒性療法，Kite公司憑藉其獨特而高效的規模化生產能力，能夠滿足患者的需求，從而造福更多患者。

Turning toward our clinical progress. Our NDA submission has been accepted by the FDA for lenacapavir for heavily treatment-experienced people living with HIV, and we are now expecting the decision in late December. If approved, lenacapavir will be the first approved capsid inhibitor and the first therapy with a 6-month dosing schedule for HIV treatment.

接下來談談我們的臨床進展。我們針對先前接受過大量治療的HIV感染者提交的lenacapavir新藥申請已獲FDA受理，預計將於12月底公佈結果。如果獲得批准，lenacapavir將成為首個核准的衣殼抑制劑，也是第一個採用6個月給藥方案的HIV治療藥物。

Moving to Trodelvy. We are in discussions with the FDA regarding a potential regulatory pathway for late-stage hormone-receptor-positive HER2-negative patients, and we will update you as things progress. We have also begun screening patients in ASCENT-03 and ASCENT-04 evaluating Trodelvy in the first-line metastatic triple-negative breast cancer patients. We dosed the first patient in our new Phase II study evaluating Trodelvy in non-small cell lung cancer, EVOKE-02. And earlier this month, we dosed the first patient in a new Trodelvy combination arm in our ongoing magrolimab triple-negative breast cancer study.

關於Trodelvy的最新進展。我們正在與FDA討論針對晚期荷爾蒙受體陽性、HER2陰性患者的潛在監管途徑，並將隨時向您通報最新進展。我們已開始在ASCENT-03和ASCENT-04研究中對患者進行篩選，以評估Trodelvy在轉移性三陰性乳癌第一線治療的療效。我們已在評估Trodelvy在非小細胞肺癌治療中的療效的II期新研究EVOKE-02中完成了首例患者的給藥。本月初，我們在正在進行的magrolimab三陰性乳癌研究中，完成了Trodelvy聯合治療組的首例患者的給藥。

Also from magrolimab, we are targeting an interim analysis no later than early 2023 for ENHANCE, our Phase III study in first-line, high-risk MDS. Additionally, we dosed the first patient for ENHANCE-3, a Phase III magrolimab study for first-line unfit AML.

此外，我們計劃在2023年初前完成高風險MDS患者第一線治療的III期臨床試驗ENHANCE的中期分析。另外，我們已為ENHANCE-3試驗的首例患者給藥，該試驗是針對不適合一線治療的AML患者的III期臨床試驗。

Moving to Slide 5. Later this year, we expect to initiate an additional 5 studies for Trodelvy in a mix of monotherapy and combination studies. We also plan to start enrolling patients in 3 cell therapy trials and 2 domvanalimab combination trials. The extent of existing and planned studies really highlights the scale of our ambitious oncology program.

接下來是第五張投影片。今年晚些時候，我們預計將啟動5項Trodelvy單藥治療和聯合治療研究。此外，我們也計劃啟動3項細胞療法試驗和2項domvanalimab合併治療試驗的病患招募工作。現有和計劃中的研究規模充分體現了我們雄心勃勃的腫瘤治療計畫的規模。

I want to take this opportunity to thank the teams across Gilead and Kite for a terrific quarter of commercial execution and for the continued momentum in our clinical programs to continue to lay the critical groundwork for Gilead's future success.

我想藉此機會感謝吉利德和凱特公司的所有團隊，感謝他們在本季度出色的商業執行工作，以及在臨床項目方面持續取得的進展，這為吉利德未來的成功奠定了關鍵的基礎。

With that, I'll invite Johanna to share an update on our second quarter commercial performance.

接下來，我將邀請 Johanna 為我們介紹第二季的商業表現。

Thanks, Dan, and good afternoon, everyone. Turning to Slide 7. We had a very strong second quarter with total product sales excluding Veklury of $5.7 billion, up 7% year-over-year, driven by HIV, Cell Therapy and Trodelvy and offset in part by HCV. Sequentially, total product sales excluding Veklury were up 14%, driven by the seasonal pricing and inventory dynamics we see coming out of the first quarter of every year, primarily in our HIV business, as well as higher demand across our total portfolio.

謝謝丹，大家下午好。請看第七張投影片。我們第二季業績非常強勁，不包括Veklury在內的產品總銷售額達57億美元，年增7%，主要得益於HIV、細胞療法和Trodelvy的強勁增長，但部分被HCV的銷售額所抵消。環比來看，不包括Veklury在內的產品總銷售額成長了14%，這主要得益於每年第一季結束後常見的季節性定價和庫存變化，尤其是在HIV業務方面，以及我們整體產品組合需求的成長。

On Slide 8, HIV sales were up 7% year-over-year to $4.2 billion, primarily driven by channel mix associated with lower government utilization, leading to a higher average realized price as well as higher demand for both treatment and PrEP. Excluding the impact of the loss of exclusivity of Truvada and Atripla, HIV sales increased 11%.

根據幻燈片8，HIV藥物銷售額年增7%至42億美元，主要受通路組合變化推動，政府用藥減少導致平均售價上漲，同時治療藥物和暴露前預防藥物（PrEP）的需求也隨之增加。若不計入Truvada和Atripla失去獨家銷售權的影響，HIV藥物銷售額將成長11%。

Quarter-over-quarter, HIV sales were up 14% due to demand and channel mix, leading to higher average realized price as well as the favorable seasonal inventory dynamics that we typically see in the second quarter relative to the first.

由於需求和通路組合，HIV 產品的銷售額環比增長 14%，導致平均實際價格上漲，並且與第一季相比，我們通常在第二季度看到的有利的季節性庫存動態也帶來了增長。

Year-over-year, the HIV treatment market grew over 4% in the U.S. and was largely flat in Europe but sequentially grew over 2% in the U.S. and 1% in Europe. We're encouraged to see the market recovering and on a year-on-year basis, continue to expect annual treatment market growth in the 2% to 3% range.

美國愛滋病治療市場年增超過4%，歐洲市場基本持平，但較上季來看，美國成長超過2%，歐洲成長超過1%。我們欣喜地看到市場正在復甦，並繼續預期愛滋病治療市場年增率將維持在2%至3%之間。

Descovy sales in the second quarter were $460 million, up 6% year-over-year and 23% sequentially. We're pleased to see continued PrEP market growth with broader awareness and market volumes that are well above pre-pandemic levels. For the quarter, the overall market growth was up 25% year-over-year and 5% sequentially, highlighting both robust recovery and growing adoption of PrEP.

Descovy第二季銷售額為4.6億美元，較去年同期成長6%，季增23%。我們很高興看到PrEP市場持續成長，市場認知度不斷提高，市場規模也遠超疫情前水準。本季整體市場年增25%，季增5%，凸顯了PrEP市場的強勁復甦和日益普及。

Despite generic and other market participants, Descovy share in PrEP is holding in the mid-40% range. As awareness continues to grow and the overall market expands, we expect Descovy to continue to play an important role in PrEP and really look forward to adding lenacapavir as a potential long-acting alternative for those seeking preventative care as early as 2025.

儘管有仿製藥和其他市場參與者，Descovy 在 PrEP 領域的市佔率仍穩定在 40% 左右。隨著公眾意識的不斷提高和整體市場的擴張，我們預計 Descovy 將繼續在 PrEP 領域發揮重要作用，並期待最早在 2025 年將 lenacapavir 作為一種潛在的長效替代藥物納入 PrEP 產品線，以滿足尋求預防性治療人群的需求。

On to Slide 9. Biktarvy grew 28% year-over-year to $2.6 billion, primarily driven by strong demand and channel mix. Biktarvy's market share in the U.S. grew from 40% in Q2 of last year to 44% in the second quarter of 2022 and continued by a wide margin to be the leading treatment for HIV as well as the fastest growing. In fact, Biktarvy's differentiated clinical profile was once again reinforced this past weekend at the International AIDS Conference in Montreal.At 5 years, Biktarvy had 0 cases of treatment failure due to resistance as well as sustained efficacy and a demonstrated safety profile in people living with HIV. Notably, this 5-year trial duration demonstrating 0 cases of resistance is unprecedented for an HIV regimen.

接下來是投影片9。 Biktarvy的銷售額年增28%，達到26億美元，主要得益於強勁的需求和通路組合的最佳化。 Biktarvy在美國的市佔率從去年第二季的40%成長到2022年第二季的44%，並持續保持領先地位，成為領先的HIV治療藥物，同時也是成長最快的藥物。事實上，Biktarvy獨特的臨床療效在上週末於蒙特婁舉行的國際愛滋病大會上再次得到印證。在為期5年的試驗中，Biktarvy未出現因抗藥性導致的治療失敗病例，並且在HIV感染者中展現出持續的療效和良好的安全性。值得注意的是，這種長達5年的試驗期間未出現抗藥性病例的情況，對於HIV治療方案而言是前所未有的。

Share also increased sequentially, up 1% from the first quarter of 2022, contributing to 19% growth in Biktarvy revenue quarter-over-quarter in addition to the channel mix and the seasonal inventory dynamics we referenced earlier.

份額也環比增長，比 2022 年第一季增長 1%，加上我們之前提到的通路組合和季節性庫存動態，使得 Biktarvy 的收入環比增長了 19%。

Moving to Slide 10. HCV sales in the quarter were down 18% year-over-year due to the channel mix leading to lower average realized price and fewer patient starts, partially offset by higher volume in Eastern Europe. Sequentially, HCV was up 12%, driven by the timing of a large order in addition to higher patient start. Overall in HCV, we maintained steady market share of 50% to 60% both in the U.S. as well as Europe.

翻到第10頁。由於通路組合變化導致平均售價下降和患者起始治療數量減少，本季丙型肝炎（HCV）銷售額較去年同期下降18%，東歐地區銷售成長部分抵銷了這一影響。環比來看，HCV銷售額成長12%，這主要得益於一筆大額訂單的及時到貨以及患者起始治療數量的增加。整體而言，我們在美國和歐洲的HCV市佔率均維持在50%至60%的穩定水準。

For HBV and HDV on Slide 11, sales were roughly flat quarter-over-quarter and year-over-year, driven by unfavorable adjustments associated with the recent volume-based procurement updates in China and offset by higher year-over-year demand and volume growth in all other regions.

如幻燈片 11 所示，HBV 和 HDV 的銷售額環比和同比基本持平，這是由於中國最近基於銷量的採購更新帶來的不利調整所致，但被所有其他地區同比更高的需求和銷量增長所抵消。

Veklury revenues in the second quarter were $445 million, as shown on Slide 12. As expected, sales declined both year-over-year and quarter-over-quarter as hospitalization rates declined in most geographies. Additionally, U.S. revenue reflected inventory drawdown in the second quarter.

如投影片12所示，Veklury第二季營收為4.45億美元。如預期，由於大多數地區的住院率下降，銷售額年比和季比均有所下降。此外，美國地區的營收也反映了第二季庫存的減少。

While COVID-19 is still prevalent, the most recent subvariants have been less severe and contributed to pure hospitalized patients, although roughly 60% of hospitalized COVID-19 patients that are being treated in the U.S. are receiving Veklury.

雖然 COVID-19 仍然很流行，但最近的亞型病情較輕，只導致住院患者，儘管在美國接受治療的 COVID-19 住院患者中約有 60% 正在接受 Veklury 治療。

We continue to be committed to supporting patients with COVID-19 globally. Last month, we signed our second joint procurement agreement with the European Commission that enables participating countries to purchase Veklury for a period of up to 18 months. Additionally, the European Medicines Agency Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion recommending Veklury received full marketing authorization for the treatment of appropriate patients with COVID-19. This builds on our prior conditional authorization, and we look forward to the final decision by the European Commission later this year.

我們始終致力於為全球新冠肺炎患者提供支援。上個月，我們與歐盟委員會簽署了第二份聯合採購協議，該協議允許參與國在長達18個月的時間內採購Veklury。此外，歐洲藥品管理局人用藥品委員會（CHMP）已發布積極意見，建議授予Veklury完全上市許可，用於治療符合條件的新冠肺炎患者。這是在我們之前獲得有條件批准的基礎上取得的進展，我們期待歐盟委員會在今年稍後做出最終決定。

We're proud of our track record of meeting global demand for Veklury since the fall of 2020, and we'll maintain a readiness to supply Veklury where it's needed and have increased our full year guidance to reflect anticipated patient need in the second half.

自 2020 年秋季以來，我們一直致力於滿足全球對 Veklury 的需求，對此我們深感自豪。我們將繼續保持隨時供應 Veklury 的準備狀態，以滿足市場需求，並已提高全年業績預期，以反映下半年患者的預期需求。

Turning to oncology and beginning with Trodelvy on Slide 13. Sales of $159 million grew 79% year-over-year and 9% quarter-over-quarter. Sequentially, Trodelvy grew 41% outside of the U.S. with particularly strong growth in Germany and France due to increased awareness and adoption. Sequential 7% volume growth in the U.S. was offset by unfavorable pricing dynamics. We expect to see continued growth in the second half, driven by the impact of our expanded sales force in the U.S. as well as reimbursement approvals in the EU.

接下來我們來看看腫瘤治療領域，首先是第13頁投影片中的Trodelvy。其銷售額達1.59億美元，年增79%，季增9%。 Trodelvy在美國以外的環比成長為41%，其中德國和法國的成長尤為強勁，這得益於市場認知度和接受度的提高。美國市場上季7%的銷售成長被不利的價格因素所抵銷。我們預計下半年將繼續保持成長，這主要得益於我們在美國擴大的銷售團隊以及歐盟健保報銷的批准。

We're committed to broadening access for Trodelvy and continue to work with regulators and payers around the world. We're pleased with the recent decisions by both NCCN in the U.S. and NICE in the U.K., recognizing the significant clinical benefit of Trodelvy in patients with metastatic triple-negative breast cancer based on the Phase 3 ASCENT trial. These decisions add to the building support for Trodelvy's use following positive health technology assessments in a number of other countries.

我們致力於擴大Trodelvy的適用範圍，並繼續與世界各地的監管機構和支付方合作。我們很高興美國國家綜合癌症網絡（NCCN）和英國國家衛生與臨床優化研究所（NICE）近期分別做出決定，認可Trodelvy基於ASCENT III期臨床試驗結果，對轉移性三陰性乳癌患者俱有顯著的臨床獲益。此前，Trodelvy已在其他多個國家獲得積極的衛生技術評估，這些決定進一步增強了其應用前景。

Trodelvy is the first ADC to demonstrate statistically significant and clinically meaningful overall survival benefit in this metastatic TNBC patient population. In fact, the NCCN guidelines elevated Trodelvy to a Category 1 recommendation for second-line and later metastatic TNBC, its highest recommendation available. Additionally, while Trodelvy is not approved by the FDA for use in HR+/HER2- setting, we're pleased that the NCCN has issued a Category 2A recommendation for Trodelvy's use for these patients with advanced disease.

Trodelvy是第一個在轉移性三陰性乳癌（TNBC）患者群體中展現出統計學意義顯著且臨床意義明確的總存活期獲益的抗體偶聯藥物（ADC）。事實上，NCCN指引已將Trodelvy的第二線及後續轉移性TNBC治療建議等級提升至1級，這是其最高等級的推薦。此外，儘管FDA尚未批准Trodelvy用於HR+/HER2-患者，但我們很高興NCCN已將Trodelvy用於此類晚期患者建議為2A級。

Turning to Slide 14. I'm pleased to share some incredibly strong results on behalf of Christi and the Kite team. Cell Therapy sales for the second quarter were $368 million, up 68% year-over-year and 34% sequentially, driven by a very strong U.S. second-line launch for Yescarta in relapsed/refractory LBCL, which exceeded our expectations and continued strong growth in third-line plus Yescarta. As a reminder, strong data and an NCCN recommendation, which predated the second-line approval, helped drive our impressive early uptake, especially in large volume authorized treatment centers with a high familiarity with CAR T therapies. Additionally, Yescarta second-line LBCL is already available in 2 other large markets: in France through the early access program and in Germany through reimbursement decisions ahead of approval. The decision on Yescarta second-line LBCL approval in Europe is expected later this fall.

請翻到第14張投影片。我很高興能代表Christi和Kite團隊分享一些非常亮眼的表現。第二季度細胞療法銷售額達3.68億美元，年增68%，環比增長34%，主要得益於Yescarta在美國復發/難治性大B細胞淋巴瘤（LBCL）二線治療市場的強勁表現，其業績超出預期，以及Yescarta三線治療聯合其他療法的持續強勁增長。需要強調的是，強有力的臨床數據和NCCN指南的推薦（該推薦早於二線治療獲批）推動了我們早期產品的顯著增長，尤其是在那些對CAR-T療法非常熟悉的大型授權治療中心。此外，Yescarta二線LBCL療法已在另外兩個大型市場上市：法國透過早期准入計劃，德國則在獲批前已獲得醫保報銷。預計今年秋季稍晚將公佈Yescarta二線LBCL療法在歐洲的核准決定。

Third-line plus LBCL deliveries also increased sequentially and year-over-year, reflecting growing overall awareness and confidence in the use of Yescarta. This follows the presentation of 5-year ZUMA-1 data at last year's American Society of Hematology meeting and more recently, our second-line approval in the U.S.

三線及以上 LBCL 治療的交付量也逐年遞增，反映出人們對 Yescarta 的整體認知度和信心不斷提高。先前，我們在去年的美國血液學會年會上發表了 ZUMA-1 的 5 年數據，最近又獲得了美國二線治療的批准。

For the quarter overall, Yescarta sales of $295 million were up 66% year-over-year and 40% sequentially. Of note, Yescarta deliveries increased 67% year-over-year and 39% sequentially, demonstrating the effectiveness of Kite's manufacturing expansion strategy and our ability to meet demand for our cell therapies. We're proud of our reputation for consistent and reliable deliveries that further differentiates Kite's cell therapies and was a continued source of strength in Q2. While we saw very strong demand in the first half of 2022, we expect this growth to normalize in Q3 as second-line usage expand beyond the early adopters and more towards community referrals.

本季整體而言，Yescarta 的銷售額為 2.95 億美元，年增 66%，季增 40%。值得注意的是，Yescarta 的交付量同比增長 67%，環比增長 39%，這充分體現了 Kite 生產擴張策略的有效性以及我們滿足市場對細胞療法需求的能力。我們為始終如一、可靠的交付能力而感到自豪，這進一步凸顯了 Kite 細胞療法的差異化優勢，也是第二季度業績持續強勁的來源。儘管我們在 2022 年上半年看到了非常強勁的需求，但我們預計隨著二線治療的應用範圍從早期採用者擴展到更多社區轉診，第三季度的增長將趨於正常。

Turning to Tecartus. Sales for the quarter were $73 million, up 78% year-over-year and 16% sequentially, driven by continued demand and expansion into new geographies for relapsed/refractory mantle cell lymphoma as well as uptake in adult acute lymphoblastic leukemia in the U.S. Christi is available for Q&A later on the call. In summary, this was a really strong quarter for the entire Gilead and Kite commercial organization.

接下來談談Tecartus。本季銷售額為7,300萬美元，年成長78%，季增16%，主要得益於市場對復發/難治性套細胞淋巴瘤的持續需求以及在新地區的拓展，同時在美國成人急性淋巴性白血病市場也取得了成長。 Christi稍後將在電話會議上回答問題。總而言之，對於整個吉利德和Kite商業團隊來說，這都是一個非常強勁的季度。

And so with that, I'll hand the call over to Merdad for an update on our pipeline.

那麼，接下來我將把電話交給梅爾達德，讓他報告我們管道的最新情況。

Thank you, Johanna. From a clinical perspective, we made solid progress in the second quarter, including a wealth of data updates spanning our oncology and virology portfolios.

謝謝你，喬安娜。從臨床角度來看，我們在第二季度取得了穩定進展，包括腫瘤學和病毒學領域大量數據的更新。

Starting with HIV on Slide 16. We're very pleased to share that our NDA submission for lenacapavir for heavily treatment-experienced people living with HIV was accepted last week, and we now have a PDUFA date set for the end of December. Outside the U.S., we received a positive CHMP opinion for this indication based on data from the Phase 2/3 CAPELLA trial. Week 26 data from this trial were published in the New England Journal of Medicine in May with updated 1-year data presented at the conference on retroviruses and opportunistic infections earlier this year.

從第16張投影片開始介紹HIV。我們非常高興地宣布，我們針對接受過大量治療的HIV感染者提交的lenacapavir新藥申請已於上週獲得受理，目前已確定PDUFA日期為12月底。在美國以外，我們基於CAPELLA II/III期試驗的數據，獲得了人用藥品委員會（CHMP）對此適應症的正面意見。該試驗第26週的數據已於5月發表在《新英格蘭醫學雜誌》上，更新的1年數據已於今年稍早在逆轉錄病毒和機會性感染會議上公佈。

In this very difficult-to-treat population, 83% to 86% of those treated with lenacapavir achieved biologic expression at 1 year, sustaining the rates achieved at week 26. We continue to expect a decision from the European Commission later this year.

在這一極難治療的人群中，接受 lenacapavir 治療的患者中有 83% 至 86% 在 1 年時達到生物學表達，並維持了第 26 週達到的水平。我們仍然期待歐盟委員會在今年稍後做出決定。

Looking to Trodelvy on Slide 17. We shared new data at ASCO that increases our confidence in Trodelvy's potential applicability across a broad range of tumor types. These positive data from the Phase 3 ASCENT study reinforced Trodelvy's survival and health-related quality-of-life benefit over treatment of physician's choice in patients with metastatic triple-negative breast cancer.

請看第17張投影片中的Trodelvy。我們在ASCO會議上分享了新的數據，這些數據增強了我們對Trodelvy在多種腫瘤類型中潛在應用價值的信心。這些來自ASCENT III期研究的正面數據進一步證實了Trodelvy在轉移性三陰性乳癌患者中，相較於醫師選擇的治療方案，能夠帶來更長的生存期和更高的健康相關生活品質獲益。

We also highlighted positive PFS and quality-of-life data from our Phase 3 TROPiCS-02 study, demonstrating a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death in late-line, endocrine-resistant patients with HR+/HER2- metastatic breast cancer, who had received a median of 3 prior lines of [chemotherapy] (corrected by company after the call) in the metastatic setting after having failed hormone therapy. This study also demonstrated a positive trend in overall survival at the first interim analysis.

我們還重點介紹了來自 3 期 TROPiCS-02 研究的積極無進展生存期 (PFS) 和生活質量數據，該研究表明，對於接受過中位數為 3 線化療（公司在電話會議後進行了更正）且激素治療失敗的晚期內分泌耐藥 HR+/HER2- 轉移性乳腺癌患者，疾病進展或死亡風險，降低了 34%，具有統計學意義。該研究在首次中期分析中也顯示出總存活期 (OS) 的正面趨勢。

The TROPiCS-02 data, coupled with the NCCN recommendation, support Trodelvy's potential as a treatment option for late-line HR+/HER2- patients. As Dan mentioned, our discussions with the FDA are ongoing on the potential regulatory path, and we'll update you when we can. In the meantime, TROPiCS-02 continues with patients being followed for subsequent planned OS analyses.

TROPiCS-02 研究數據，結合 NCCN 指引的推薦，支持 Trodelvy 作為晚期 HR+/HER2- 患者的治療選擇。正如 Dan 所提到的，我們正在與 FDA 就潛在的監管路徑進行討論，一旦有最新消息，我們會及時更新。同時，TROPiCS-02 研究仍在繼續，患者正在接受隨訪，以進行後續的計劃性總生存期 (OS) 分析。

Separately, we continue to expand our Trodelvy clinical program. We began screening for patients in ASCENT-03, evaluating Trodelvy in first-line metastatic TNBC patients who have PD-L1 negative tumors as well as in the ASCENT-04 study evaluating first-line patients with PD-L1 positive metastatic TNBC.

此外，我們繼續擴大 Trodelvy 的臨床計畫。我們已開始在 ASCENT-03 研究中篩選患者，評估 Trodelvy 在第一線治療 PD-L1 陰性轉移性 TNBC 患者的療效；同時，我們也在 ASCENT-04 研究中評估 Trodelvy 在第一線治療 PD-L1 陽性轉移性 TNBC 患者中的療效。

Moving to Trodelvy in bladder cancer. The ongoing Phase 3 TROPiCS-04 study is our confirmatory trial designed to enable global registration for Trodelvy in patients with locally advanced or metastatic urothelial cancer. This study follows an encouraging data -- the encouraging data from TROPHY U-01, supporting accelerated approval of Trodelvy in the U.S. for patients with mUC. Pending results from our first-line expansion cohorts in the Phase 2 TROPHY U-01 study, we plan to open 2 Phase 3 studies in [first-line] (corrected by company after the call) mUC.

推進Trodelvy在膀胱癌領域的應用。正在進行的3期TROPiCS-04研究是一項確證性試驗，旨在為Trodelvy在全球範圍內獲批用於治療局部晚期或轉移性尿路上皮癌患者提供依據。這項研究基於令人鼓舞的數據——TROPHY U-01研究的令人鼓舞的數據，該數據支持Trodelvy在美國加速批准用於治療轉移性尿路上皮癌（mUC）患者。在獲得2期TROPHY U-01研究第一線擴展隊列的結果後，我們計劃啟動兩項針對一線mUC的3期研究（公司在電話會議後更正了這一點）。

In our Trodelvy lung program, we initiated the Phase 2 EVOKE-02 non-small cell lung cancer study in the second quarter, evaluating the combination of Trodelvy with Merck's Keytruda in patients without actionable genomic mutations.

在我們的 Trodelvy 肺癌計畫中，我們於第二季度啟動了 2 期 EVOKE-02 非小細胞肺癌研究，評估 Trodelvy 與默克公司的 Keytruda 聯合用於無可操作基因組突變的患者的效果。

Looking forward to the second half of the year, we expect to begin enrolling patients with the Phase 3 EVOKE-03 or KEYNOTE-D46 study in first-line non-small cell lung cancer with PD-L1 expression levels greater than equal to 50% in collaboration with our partners at Merck. Additionally, later this year, we expect to initiate several other Trodelvy combinations, including evaluating Trodelvy in castrate-resistant prostate cancer.

展望下半年，我們預計將與默克公司合作，啟動針對一線治療PD-L1表達水平≥50%的非小細胞肺癌患者的III期EVOKE-03或KEYNOTE-D46研究。此外，我們預計今年稍後還將啟動其他幾項Trodelvy聯合療法的研究，包括評估Trodelvy在去勢抵抗性前列腺癌的療效。

Moving to magrolimab on Slide 18. We're pleased that both divisions of the FDA have now lifted the partial clinical hold on magrolimab. All magrolimab programs have resumed enrolling patients without FDA requiring any additional protocol changes. Our confidence in magrolimab's potential efficacy and safety profile is unchanged.

幻燈片18，我們來看magrolimab。我們很高興FDA的兩個部門都已解除magrolimab的部分臨床試驗暫停。所有magrolimab項目均已恢復患者招募，FDA未要求對方案進行任何額外更改。我們對magrolimab的潛在療效和安全性充滿信心。

At ASCO, we shared MDS and AML data from our Phase 1b study when magrolimab continues to demonstrate high and durable response rates in high-risk MDS with encouraging complete response rate of 33% compared with the historical rates of azacitadine-alone. We also observed promising efficacy in patients with TP53 mutant AML with an ORR of 49% and a CR of 33%.

在ASCO會議上，我們分享了1b期研究中MDS和AML的資料。結果顯示，magrolimab在MDS高風險患者中持續展現出高且持久的緩解率，完全緩解率高達33%，高於先前阿扎胞苷單藥治療的緩解率。此外，我們也觀察到magrolimab在TP53突變型AML患者中也具有良好的療效，客觀緩解率（ORR）為49%，完全緩解率（CR）為33%。

Notably, our Phase 3 study in frontline HR MDS ENHANCE has been rolling nicely, and we expect the interim analysis no later than early 2023.

值得一提的是，我們針對第一線 HR MDS 患者的 3 期研究 ENHANCE 進展順利，我們預期中期分析最遲將於 2023 年初進行。

Moving to Cell Therapy on Slide 19. On behalf of Christi and the Kite team, it's gratifying to see that more patients are benefiting from our cell therapies given the growing body of clinical evidence. Building on the ZUMA-7 data, we presented real-world data at ASCO that demonstrated consistent outcomes for survival and safety regardless of race and ethnicity. And in sub-analysis of ZUMA-7, patients over 65, Yescarta demonstrated more than 8x greater median event-free survival and a clinically meaningful improvement in quality of life.

幻燈片19：細胞療法。我代表Christi和Kite團隊，欣慰地看到越來越多的患者受益於我們的細胞療法，這得益於不斷累積的臨床證據。基於ZUMA-7的數據，我們在ASCO會議上展示了真實世界數據，這些數據表明，無論種族和民族如何，患者的生存期和安全性均保持一致。在ZUMA-7的亞組分析中，Yescarta在65歲以上患者中顯示出超過8倍的中位無事件存活期，以及具有臨床意義的生活品質改善。

These data further establish the efficacy and safety profile of Yescarta for patients with relapsed or refractory LBCL and support ongoing exploration of Yescarta in more settings. We expect to enroll our first patient for ZUMA-24, a Phase 2 study to evaluate Yescarta in second-line LBCL, in an outpatient setting; as well as ZUMA-23, a Phase III study to evaluate Yescarta in first-line, high-risk LBCL patients, in the second half of this year. Additionally, we expect first patient in, in a new Phase III trial evaluating the use of Yescarta in second-line HR follicular lymphoma patients, ZUMA-22, later this year.

這些數據進一步證實了Yescarta對復發或難治性大B細胞淋巴瘤（LBCL）患者的療效和安全性，並支持在更多情況下繼續探索Yescarta的應用。我們預計將在今年下半年招募首例患者參與ZUMA-24研究，這是一項評估Yescarta用於二線LBCL治療的II期臨床研究，將在門診進行；同時，我們也預計將在今年下半年招募首例患者參與ZUMA-23研究，這是一項評估Yescarta用於一線高危CL治療的III期臨床研究。此外，我們預計將在今年稍後招募首例患者參與ZUMA-22研究，這是一項評估Yescarta用於二線高風險濾泡性淋巴瘤治療的III期臨床研究。

Now to Slide 20. As Dan mentioned, we made steady progress in the first half of the year and continue to focus on clinical execution. The key clinical milestones in the second half include: an update on our regulatory discussions for Trodelvy for late-line HR+/HER2- patients in the U.S.; a number of potential regulatory decisions, including for lenacapavir, Yescarta and Tecartus; at least 6 more trial initiations spanning Trodelvy, cell therapy and domvanalimab; as well as several data updates with our partner, Arcus, including Phase 2 data from ARC-7.

現在來看第20張投影片。正如Dan所提到的，我們在今年上半年取得了穩步進展，並將繼續專注於臨床實施。下半年的關鍵臨床里程碑包括：更新我們在美國針對晚期HR+/HER2-患者的Trodelvy的監管諮詢進展；多項潛在的監管決定，包括lenacapavir、Yescarta和Tecartus；至少啟動6項新的臨床試驗，涵蓋Trodelvy、細胞療法和domvanalimab；以及與合作夥伴Arcus-7II的多項數據，包括共享數據期。

Later this year, we also expect to have interim Phase 2 data for etruma from the ARC-6 study as well as ARC-8's Phase 2 data for quemli.

今年晚些時候，我們還將獲得 ARC-6 研究的 etruma 的 2 期中期數據，以及 ARC-8 研究的 quemli 的 2 期數據。

We're encouraged with the early Phase 1 data for GS-5245, our investigational novel oral nucleoside in development for the treatment of COVID-19. We're discussing these early data with regulatory agencies and are planning to move into the clinic.

我們對GS-5245（一種正在研發用於治療COVID-19的新型口服核苷類藥物）的早期I期臨床試驗數據感到鼓舞。我們正在與監管機構討論這些早期數據，並計劃推進臨床試驗。

We're also pleased to see our earlier-stage pipeline with our partners such as Tizona and Pionyr continue to advance nicely. For example, Tizona's HLA-G program is currently enrolling its dose expansion cohorts, and Tizona expects to share interim data mid-2023.

我們也很欣喜地看到，與Tizona和Pionyr等合作夥伴的早期研發管線持續取得良好進展。例如，Tizona的HLA-G計畫目前正在招募劑量擴展隊列受試者，預計2023年中期公佈中期數據。

With our robust internal pipeline and external partners, we're confident in our portfolio across virology, oncology and inflammation will deliver many life-changing treatments to help those patients in need.

憑藉我們強大的內部研發管線和外部合作夥伴，我們有信心，我們在病毒學、腫瘤學和發炎領域的研發產品組合將為有需要的患者提供許多改變人生的治療方案。

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

這樣，我就把電話交給安迪了。

Thank you, Merdad, and good afternoon, everyone. Before I discuss our second quarter results and starting on Slide 22, I would like to remind everyone that following the SEC guidance earlier this year, similar to our peers, acquired in-process R&D expenses or IPR&D, including upfront payments for business development transactions, are now included in our non-GAAP financial measures and reported under Acquired IPR&D. As a reminder, the $300 million payment associated with the Dragonfly collaboration announced in May is included in our Q2 results but was not reflected in our prior 2022 full year guidance.

謝謝Merdad，大家午安。在討論我們第二季業績之前（從第22張投影片開始），我想提醒大家，根據美國證券交易委員會（SEC）今年稍早的指導意見，與同業類似，收購的在研研發費用（IPR&D），包括業務拓展交易的預付款，現在已納入我們的非GAAP財務指標，並在「收購在研發費用」項示。需要提醒的是，5月宣布的與Dragonfly合作相關的3億美元付款已計入我們第二季業績，但並未反映在我們之前的2022年全年業績指引中。

Additionally, we have shifted prior period milestone and opt-in payments from R&D to Acquired IPR&D. We believe this presentation better reflects the total costs incurred to acquire IPR&D projects. The most notable example is the $625 million opt-in payment we made to Arcus that we reported in the fourth quarter of last year. There are a few other smaller payments that have been moved, and this slide highlights the changes that you'll now see reflected in our 2021 P&L. I'll further note that this change impacts our 2022 R&D guidance because our R&D guidance is given relative to our 2021 results. I'll touch on that again later in this call.

此外，我們將先前階段的里程碑付款和選擇加入付款從研發專案轉移到了已收購的智慧財產權開發專案。我們認為，這樣的調整更能反映收購知識產權開發案所產生的總成本。最顯著的例子是我們去年第四季向Arcus支付的6.25億美元選擇加入付款。還有一些其他金額較小的付款也進行了調整，這張投影片重點介紹了您將在我們的2021年損益表中看到的變化。我還要指出，這項變更會影響我們2022年的研發預期，因為我們的研發預期是基於2021年的業績給出的。稍後我會在電話會議中再次提及這一點。

Moving to our second quarter results, starting on Slide 23. This was a very strong quarter with a notable contribution from both our HIV and our oncology businesses. As expected, Veklury sales were substantially lower sequentially and year-over-year, reflecting the lower COVID hospitalization rates in the quarter. Total product sales, excluding Veklury, were up 7% year-over-year. Foreign currency impacted second quarter sales, excluding Veklury, by approximately $65 million net of hedges. If we exclude this impact as well as the impact of the HIV LOEs, total underlying sales growth year-over-year was 11% in the quarter. For the first half, total product sales growth excluding Veklury was 5%. Also excluding FX and the impact of the HIV LOEs, underlying growth for the first half was 8%.

接下來是第二季業績，從第23頁投影片開始。本季業績表現強勁，HIV和腫瘤業務均貢獻顯著。如預期，Veklury的銷售額較上季和年比均大幅下降，反映出本季新冠肺炎住院率較低。不計Veklury，產品總銷售額較去年同期成長7%。外匯波動對第二季不計Veklury的銷售額造成了約6500萬美元的淨影響（已扣除對沖收益）。若剔除外匯波動及HIV業務延期付款的影響，本季基本銷售額年增11%。上半年，不計Veklury，產品總銷售額成長5%。同樣剔除外匯波動和HIV業務延期付款的影響，上半年基本銷售額成長8%。

Back to our reported results on Slide 24. Johanna took you through our revenue results and the drivers there.

回到我們在第 24 頁投影片中報告的結果。 Johanna 向大家介紹了我們的收入結果及其驅動因素。

Non-GAAP product gross margin was 85.6% for the second quarter, down 80 basis points year-over-year, primarily due to the Biktarvy-related royalty following the settlement in the first quarter of this year.

第二季非GAAP產品毛利率為85.6%，年減80個基點，主因是今年第一季與Biktarvy達成和解後產生的特許權使用費。

Non-GAAP R&D excluding Acquired IPR&D expenses, such as milestones and upfront payments, was $1.1 billion, up 6% year-over-year, primarily due to increased investment in development and timing of clinical trial activities, primarily for our oncology business.

不包括收購智慧財產權和研發費用（如里程碑付款和預付款）的非GAAP研發支出為11億美元，年增6%，主要原因是增加了對研發和臨床試驗活動時間安排的投資，主要針對我們的腫瘤業務。

Acquired IPR&D for the quarter was $330 million, including $300 million related to the Dragonfly collaboration.

本季收購的智慧財產權和研發支出為 3.3 億美元，其中包括與 Dragonfly 合作相關的 3 億美元。

Non-GAAP SG&A was $1.3 billion, up 13% year-over-year, primarily due to increased promotional and marketing activities, including for Trodelvy as well as higher corporate expenses, including IT investments and grants.

非GAAP SG&A 為 13 億美元，年增 13%，主要原因是促銷和行銷活動增加（包括 Trodelvy 的促銷和行銷活動），以及企業支出增加（包括 IT 投資和撥款）。

Non-GAAP operating margin was 43%, reflecting higher operating expenses and the upfront Dragonfly payment. Excluding the Dragonfly payment, non-GAAP operating margin was 47.5% for the quarter.

非GAAP營業利益率為43%，主要受營運費用增加及預付的Dragonfly款項影響。若不計入Dragonfly款項，該季非GAAP營業利益率為47.5%。

Moving to tax. Our non-GAAP effective tax rate in the second quarter was 19.3%.

接下來談談稅務方面。我們第二季的非GAAP實際稅率為19.3%。

Our non-GAAP diluted earnings per share was $1.58 in the second quarter of 2022 compared to $1.81 for the same period last year, reflecting the Dragonfly payments which represented $0.18 on a post-tax per share basis as well as the Biktarvy-related royalty.

2022 年第二季度，我們的非 GAAP 稀釋後每股收益為 1.58 美元，而去年同期為 1.81 美元，這反映了 Dragonfly 的付款（稅後每股收益為 0.18 美元）以及與 Biktarvy 相關的特許權使用費。

Overall, we had a strong first half of the year, as shown on Slide 25, with growth across HIV, cell therapy and Trodelvy, offset in part by HCV. Of note, currency headwinds impacted the first half total product sales by approximately $180 million net of hedges compared with the first half of 2021.

整體而言，如投影片25所示，我們上半年業績強勁，HIV、細胞療法和Trodelvy都實現成長，但部分被HCV業務的下滑所抵消。值得注意的是，匯率波動導致上半年產品總銷售額（扣除對沖收益後）較2021年上半年減少了約1.8億美元。

Moving to Slide 26. We are increasing our full year sales guidance to reflect our year-to-date results and our expectations for the second half, including our expectations for FX. In addition to the impact in the first half, we expect continued FX headwinds in the second half, impacting total product sales by approximately $200 million in the rest of the year compared to our initial February guidance.

請看第26頁投影片。我們上調了全年銷售預期，以反映年初至今的業績以及我們對下半年的預期，包括我們對匯率的預期。除了上半年的影響外，我們預計下半年匯率波動將持續，與我們2月份的初步預期相比，這將使全年剩餘時間的總產品銷售額減少約2億美元。

For revenues, we now expect total product sales of $24.5 billion to $25 billion compared to our previous range of $23.8 billion to $24.3 billion. This reflects the strong performance year-to-date, notably very strong growth in Cell Therapy and HIV, and it also incorporates our expectations for the broader macro environment.

營收方面，我們現在預期產品總銷售額為245億美元至250億美元，高於先前預測的238億美元至243億美元。這反映了年初至今的強勁業績，尤其是細胞療法和愛滋病治療領域的強勁成長，同時也包含了我們對整體宏觀環境的預期。

In HIV, we expect modest sequential growth in the third quarter, keeping in mind the strength we experienced in the second quarter. And in Cell Therapy, we expect flat to modestly higher revenue in the third quarter compared to Q2. Following the launch bolus of orders we experienced in the second quarter, we expect demand to stabilize.

鑑於第二季強勁的成長勢頭，我們預期愛滋病治療業務第三季將實現溫和的環比成長。細胞療法業務第三季營收預計與第二季持平或略有成長。繼第二季訂單激增之後，我們預計需求將趨於穩定。

Moving to Veklury. And with the first half revenue of almost $2 billion, we're increasing our expectations to approximately $2.5 billion for the year. Following inventory drawdown in the second quarter, we expect sales to increase sequentially in the United States and to continue to track hospitalization rates. Note that our Veklury guidance assumes no significant increase in hospitalization rates from Q2 levels.

接下來談談Veklury。上半年營收接近20億美元，因此我們將全年營收預期上調至約25億美元。第二季庫存下降後，我們預計美國市場的銷售額將環比成長，並將繼續密切關注住院率。需要注意的是，我們對Veklury的業績指引是基於住院率不會較第二季顯著上升的假設。

Excluding Veklury, we expect our total product sales to be $22 billion to $22.5 billion, representing growth of 3% to 5% year-over-year and compared to our prior range of $21.8 billion to $22.3 billion.

除 Veklury 外，我們預計產品總銷售額將達到 220 億美元至 225 億美元，年增 3% 至 5%，而我們先前預期的範圍為 218 億美元至 223 億美元。

As for the rest of the non-GAAP P&L, there is no change to our product gross margin guidance range of 85% to 86%.

至於其他非GAAP損益表，我們的產品毛利率預期範圍仍為85%至86%，沒有變動。

R&D, as described earlier, will no longer include BD-related payments such as milestones and opt-in fees. These will be reported as Acquired IPR&D along with upfront payments. With this change, we have moved $762 million of full year 2021 expense from R&D to Acquired IPR&D. As a result of this change, we now expect full year R&D expense to increase by a mid-single-digit percentage compared to the new 2021 baseline of $4.5 billion. Our expectations for full year R&D expense remained largely unchanged from the start of the year, and this guidance revision reflects only the recasting of Acquired IPR&D items, including Arcus, previously reported in R&D in 2021.

如前所述，研發費用將不再包含與業務拓展相關的付款，例如里程碑付款和選擇加入費。這些款項將與預付款一起計入「已收購知識產權及研發」項下。此次調整後，我們將2021財年全年研發費用中的7.62億美元從研發費用轉移至「已收購智慧財產權及研發」項下。因此，我們預計全年研發費用將較2021年新的基準值45億美元成長中個位數百分比。我們對全年研發費用的預期與年初基本保持一致，此次調整僅反映了對「已收購知識產權及研發」項目的重新調整，其中包括先前在2021年研發費用中列示的Arcus項目。

Moving to Acquired IP R&D. We are not issuing guidance for the full year and similar to what we did with the Dragonfly deal this quarter, we'll update our EPS guidance quarterly as needed to reflect any relevant activity during the quarter. What we have included here is the year-to-date Acquired IPR&D amounts.

接下來談談收購知識產權研發。我們不發布全年業績指引，與本季對 Dragonfly 交易的處理方式類似，我們將根據季度內的任何相關活動，按需更新每股收益指引。此處列出的是年初至今的收購智慧財產權研發金額。

For SG&A, with our continued investment across our commercial organization and expectations for higher costs as a result of inflation, we now expect SG&A expenses to grow by a low single-digit percentage compared to 2021.

對於銷售、一般及行政費用，由於我們在商業組織中持續投資，並且由於通貨膨脹導致成本上升，我們現在預計銷售、一般及行政費用將比 2021 年增長個位數百分比。

Altogether, we expect operating income to be $11 billion to $11.6 billion for the full year compared to $10.7 billion to $11.5 billion previously.

總的來說，我們預計全年營業收入將達到 110 億美元至 116 億美元，而先前的預期為 107 億美元至 115 億美元。

Similarly, we now expect our non-GAAP diluted earnings per share to range between $6.35 to $6.75, up from $6.20 to $6.70 previously.

同樣，我們現在預計非GAAP稀釋後每股盈餘將在6.35美元至6.75美元之間，高於先前的6.20美元至6.70美元。

On a GAAP basis, we expect our diluted earnings per share to range between $2.90 and $3.30 compared to $3.00 and $3.50 previously, primarily reflecting net unrealized losses from strategic equity investments.

以美國通用會計準則 (GAAP) 計算，我們預計稀釋後每股收益將在 2.90 美元至 3.30 美元之間，而此前為 3.00 美元至 3.50 美元，這主要反映了戰略股權投資的未實現淨虧損。

As a reminder, this revised EPS guidance reflects the $300 million upfront payment associated with the Dragonfly collaboration we announced in May, which was not included in our previous guidance as well as our FX expectations and operating expenses for the second half.

提醒一下，此次修訂後的每股收益預期反映了我們在 5 月宣布的與 Dragonfly 合作相關的 3 億美元預付款，這筆款項並未包含在我們先前的預期中，此外還反映了我們對下半年的外匯預期和營運支出。

The guidance share today does not include additional upfront payments related to normal course of business partnerships or licensing deals that we might announce in the third or fourth quarters. As discussed previously, we will continue to update our guidance as needed to reflect the impact of any new business development transactions closed in the prior quarter.

今天發布的業績指引不包括我們在第三或第四季可能宣布的與正常業務合作或授權協議相關的額外預付款。如前所述，我們將根據需要持續更新業績指引，以反映上一季完成的任何新業務拓展交易的影響。

Finally, on Slide 27, you can see there is no change to our capital allocation priorities. In the quarter, we returned almost $1 billion to shareholders, including $920 million in dividend payments. And just after the close of the quarter, we repaid $1 billion of debt, fulfilling our commitment to repay $1.5 billion of debt this year. I'm pleased to share that as of July 1, we have returned to the same debt level we were at prior to the Immunomedics acquisition.

最後，在第27張投影片中，您可以看到我們的資本配置優先事項沒有改變。本季度，我們向股東返還了近10億美元，其中包括9.2億美元的股息支付。季度末之後，我們償還了10億美元的債務，履行了今年償還15億美元債務的承諾。我很高興地宣布，截至7月1日，我們的債務水準已恢復到收購Immunomedics之前的水準。

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

接下來，我將邀請接線生開啟問答環節。

(Operator Instructions) Our first question comes from the line of Brian Abrahams with RBC Capital.

（操作員說明）我們的第一個問題來自 RBC Capital 的 Brian Abrahams。

Congratulations on the quarter. I recognize that the discussions around Trodelvy in HR+/HER- population are ongoing. But I'm just wondering, broadly speaking, if you can talk about the key things that you'll be focusing on with regards to the data and if there are certain subpopulations you might expect to gear towards from either a labeling or commercial perspective.

恭喜您本季取得佳績。我知道關於Trodelvy在HR+/HER-人群中的討論仍在進行中。但我只是想了解一下，您能否就數據方面重點關注的關鍵點談談，以及從標籤或商業角度來看，您是否計劃重點關注某些特定人群？

Brian, this is Merdad. I guess I'll start with that. For us right now, as we go forward with the study, I think we'll continue our focus on, of course, the OS evolution of the trial. And I think as we see how those data evolve over time, we will use that in our discussions with regulators as we go forward.

布萊恩，我是梅爾達德。我想我就從這裡開始吧。就我們目前而言，隨著研究的推進，我認為我們將繼續專注於試驗中總存活期（OS）的演變。隨著這些數據隨時間推移而變化，我們將把這些資訊用於與監管機構的後續討論中。

In terms of additional subpopulations, of course, we'll keep an eye on a number of things in terms of whether it's line of therapy or those sorts of subpopulations or duration of prior therapy, which were all part of the original analysis. But those were -- it's consistent with what we've already shown at ASCO and the data that we've presented and shared with you. So it will be consistent with what we've already shown.

至於其他亞群人群，我們當然會密切關注許多因素，例如治療方案、亞組人群類型以及既往治療持續時間等，這些都包含在最初的分析中。但這些結果與我們在ASCO會議上展示的內容以及我們已向各位呈現和分享的數據是一致的。因此，它將與我們已展示的內容保持一致。

Our next question comes from Geoff Meacham with Bank of America.

下一個問題來自美國銀行的傑夫‧米查姆。

Johanna or Christi, the cell therapy segment which you guys called out had a huge quarter, I'm just curious how much of the demand do you think is sustainable? I mean was it mostly driven by the new second-line label? Or did the total end market expand meaningfully? I guess I'm trying to figure out whether we reached a tipping point overall for reimbursement access in cell therapy.

Johanna 或 Christi，你們提到的細胞療法領域本季表現非常強勁，我很好奇你們認為這種需求有多少是可持續的？我的意思是，這主要是由新的二線適應症標籤所推動的嗎？還是說整個終端市場都出現了顯著成長？我想弄清楚的是，細胞療法的醫療保險報銷是否已經達到了一個臨界點。

Thanks, Geoff. Christi, over to you, please.

謝謝你，傑夫。克里斯蒂，請你發言。

Yes. Thanks, Geoff, for the question. I'll start with the second piece, reimbursement. Our reimbursement is really good. We have 98% access, and that's Medicaid, Medicare and commercial. Even with the second-line launch, in less than 1 quarter, we already have -- we already had 94% paid for across those 3 groups, so we reimbursed (inaudible). In terms of the uptake, your first point of your question, the uptake that we've seen since launch is first primarily due to second line. We've seen the patients that are going for stem cell transplants are the ones that are getting referred instead of that transplant to second-line Yescarta. So that is our initial bolus.

是的。謝謝Geoff的提問。我先回答第二個問題，報銷。我們的報銷情況非常好。 98%的報銷率，包括醫療補助、醫療保險和商業保險。即使是二線療法上市，不到一個季度，這三個族群（醫療補助、醫療保險和商業保險）的報銷率也已經達到94%，所以我們的報銷率很高（聽不清楚）。關於市場接受度，你的第一個問題，自上市以來，我們看到的市場接受度成長主要歸功於二線療法。我們發現，原本需要進行幹細胞移植的患者，現在被轉診到二線療法Yescarta，而不是直接進行移植。這是我們最初的推動力。

So what we expect is we've had this 68% year-over-year growth, 34% quarter-over-quarter. But we do believe that this is a bolus, and we expect the second half of the year going forward that -- we expect that growth to normalize to historical rates as that growth becomes more dependent on the referrals from the community. So we expect it to be still a really good growth, but we do believe that this is a bolus in the second line of the patients that exist in the ATCs and for the rest of the year. Just to reiterate that, that growth will return to more historic growth rates.

因此，我們預計今年的年成長率為 68%，環比成長率為 34%。但我們認為這只是一個短暫的成長，預計下半年，隨著成長更依賴社區轉診，成長速度將恢復到歷史水平。因此，我們預計成長仍然會非常可觀，但我們認為這只是針對現有 ATC 患者群體以及今年剩餘時間成長的一個小高峰。再次強調，成長速度最終會回歸到歷史水準。

Our next question comes from Tyler Van Buren with Cowen.

下一個問題來自 Cowen 公司的 Tyler Van Buren。

Can you guys please provide your latest thoughts regarding the potential impact that drug pricing reform could have on Gilead's business and perhaps Biktarvy in particular given the significant concentration of HIV sales to the product and its longer patent life?

鑑於Biktarvy在HIV產品銷售中佔據重要地位且專利期較長，請問各位能否分享一下你們對藥品定價改革可能對吉利德公司業務，尤其是該產品可能產生的潛在影響的最新看法？

Yes. Thanks, Tyler. I mean I'll start. This is Dan. I mean I think it's important for everybody on the call to note that we, as a company, and I think as an industry, are very focused on the fundamental issue in the U.S., which is reducing patient out-of-pocket costs. And there are lots of different ways to do that. Unfortunately, the current legislation falls very short of making an impact upon patients. And in particular, the negotiation part of the proposal is really a -- I think a real dangerous precedent in terms of potentially reducing forward innovation.

是的，謝謝，泰勒。我先來。我是丹。我認為所有參加電話會議的人都應該注意到，我們公司，甚至整個產業，都非常關注美國的一個根本問題，那就是降低病患的自付費用。有很多方法可以做到這一點。遺憾的是，目前的立法對病患的影響微乎其微。尤其值得一提的是，提案中的談判部分——我認為——開了一個非常危險的先例，可能會阻礙未來的創新。

I think in terms of how -- as you know, Tyler, the bill is still very much in discussion right now, and it's very difficult to determine the full impact. What I would say is it's several years away, first of all, from the first impact. And of course, in the Part D area of the reform, that could have some impact on our business but also help patient out-of-pocket costs.

我認為，正如你所知，泰勒，這項法案目前仍在熱烈討論中，很難確定其全部影響。首先，它至少還需要幾年時間才能產生初步影響。當然，改革中關於D部分的內容可能會對我們的業務產生一些影響，但同時也有助於降低病患的自付費用。

I think when one starts to think about the negotiation aspect of the bill, it's still, I think, too premature to think about exactly how that could affect, and it is later in the decade in terms of its impact. So let's take it one step at a time, I think, to first see what happens with the current legislation, the discussions going on in Washington. Rest assured that we are actively involved in supporting what we think are patient-oriented benefits here and adjustments to the program. And then once -- and we'll see where that goes over the coming weeks and months, we'll be able to give you even more clarity on how things might impact our business.

我認為，現在就考慮法案的談判層面還為時過早，很難準確判斷其具體影響，畢竟其影響要到十年後才會顯現。所以，我們不妨一步一步來，先看看目前的立法進展，以及華盛頓正在進行的討論。請放心，我們積極參與，支持我們認為以病人為中心的福利措施和計畫調整。之後——我們將觀察未來幾週或幾個月的發展情況——我們將能夠更清晰地說明這些措施可能對我們業務產生的影響。

But overall, I would just emphasize the strength of our portfolio is strong. I mean we have tremendous new innovations coming out of the pipeline. We have continued growth in our HIV business and beyond. And I think the innovation cycle at Gilead is very sound.

但總的來說，我想強調的是，我們的產品組合非常強大。我的意思是，我們有很多極具潛力的創新產品正在研發中。我們在愛滋病業務及其他領域都持續成長。我認為吉利德的創新週期非常穩健。

Our next question comes from Olivia Brayer with Cantor Fitzgerald.

我們的下一個問題來自 Cantor Fitzgerald 的 Olivia Brayer。

Are you guys seeing any impact from monkeypox on the HIV business? Is that a headwind you're factoring into guidance at this point for second half of the year?

你們覺得猴痘疫情對愛滋病業務有影響嗎？在製定下半年業績預期時，你們是否已將此因素納入考量？

Sure, Olivia. It's Johanna. Let me take that one on. Speaking with a lot of our specialists across the U.S. but also in Europe, they have seen obviously the rising number of monkeypox. And there is a correlation with both our HIV treatment business but also with prevention because the general percentage, the higher percentage of folks that are experiencing monkeypox are actually men having sex with men. And so obviously, that's the overlap.

當然，奧利維亞。我是喬安娜。讓我來回答這個問題。我和美國以及歐洲的許多專家交流過，他們都注意到猴痘病例明顯增加。這與我們的愛滋病治療業務以及預防工作有關，因為感染猴痘的人群中，男男性行為者的比例更高。所以很明顯，這就是兩者之間的重疊之處。

So on the contrary, we're not seeing an impact to our HIV business. We're actually seeing more screening and diagnosis that are coming in, in light of that and because of that close association. So I do think -- and the same people are treating. The prevention piece is actually a really important piece of the puzzle to try to prevent moving forward with monkeypox and getting the vaccines in. So definitely more on the positive front of our HIV business and how ever we can support that, that's what we're trying to do right now.

因此，恰恰相反，我們並未看到愛滋病業務受到影響。事實上，由於疫情的密切關聯，我們看到篩檢和診斷病例增加。所以我認為——而且治療人員也與疫情相同——預防工作實際上是至關重要的一環，有助於我們推進猴痘的防治工作並推廣疫苗接種。因此，愛滋病業務方面無疑呈現出積極的態勢，而我們目前正在盡一切努力支持這項工作。

Our next question comes from Umer Raffat with Evercore.

我們的下一個問題來自 Evercore 公司的 Umer Raffat。

I had a question and a clarification. First, maybe the question. I think, Merdad, you hinted, you are or you will be discussing early oral remdesivir data with the FDA. I'm curious if you saw any viral load benefit as well as whether the EC90 -- how much EC90 tracks above the C trough. And then clarification was on TIGIT ARC-7 because the slides on last quarter implied we're expecting PFS data -- Phase II PFS data in the second half, but today's slides only say Phase II data. So maybe if you could clarify if there's still a chance PFS could be part of the data update.

我有一個問題和一個需要澄清的地方。首先，我想問的是，Merdad，你之前暗示過，你正在或即將與FDA討論早期口服瑞德西韋的數據。我很想知道你是否觀察到病毒量方面的益處，以及EC90（EC90在谷濃度以上達到多少）的情況。其次，我想澄清一下TIGIT ARC-7試驗，因為上個季度的投影片暗示我們預計下半年會公佈PFS數據——也就是II期PFS數據，但今天的投影片只提到了II期數據。所以，你能不能澄清一下，PFS數據是否還有可能包含在這次的數據更新中？

Yes. Thanks for the questions. So as far as the oral new program for COVID-19 goes, the Phase I study is in healthy volunteers. So we don't expect to see anything other than safety and PK in that study. And all I can say is I think things have gone very well with that trial so far both from a tolerability and an exposure standpoint. So we're very happy with where we are. And now we'll move into the proof-of-concept and clinical development stage. So no viral load data to share.

是的，謝謝您的提問。關於針對新冠病毒的口服新藥項目，目前I期臨床試驗是在健康志願者中進行的。因此，我們預期該研究除了安全性和藥物動力學數據外，不會涉及其他方面。就目前而言，我認為無論從耐受性或藥物暴露量來看，該試驗進展都非常順利。我們對目前的進展非常滿意。接下來，我們將進入概念驗證和臨床開發階段。因此，目前沒有病毒量數據可以分享。

And then in terms of the ARC-7 data, I don't think -- I guess I would suggest not overreading. We are working with Arcus, and we will -- as the data roll out, we will be sharing data -- Arcus, and we will be sharing data from the ARC-7 study later on this year and the data that we will have. We're not really detailing what those data are going to look like right now. But be assured that we'll work with them to show data later this year.

至於ARC-7的數據，我認為──我建議不要過度解讀。我們正在與Arcus合作，隨著數據的陸續發布，我們將分享數據——包括Arcus的數據以及我們掌握的ARC-7研究數據。目前我們暫不透露這些數據的具體內容。但請放心，我們將與他們合作，在今年稍後公佈數據。

Our next question comes from Matthew Harrison with Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

I was just hoping you could talk a little bit about Trodelvy demand in the U.S. Sort of sequentially, growth has slowed pretty significantly over the last couple of quarters here. Is that mostly a reflection that you've penetrated most of the triple-negative market and you need label expansion in that growth? Or are there other factors there from a sequential growth standpoint?

我希望您能談談Trodelvy在美國的需求情況。過去幾個季度，其成長速度明顯放緩。這主要是因為你們已經滲透了大部分三重負型香水市場，需要透過拓展產品線來滿足成長需求嗎？還是說，從成長的角度來看，還有其他因素導致成長放緩？

Thanks, Matthew. It's Johanna. Let me try to give you a little bit more context. So as you saw from a global standpoint, we had really strong growth across the board. A lot of that growth, as you're referring to, comes from some of the market launches in Europe, namely France and Germany, where there's been a bit of a bolus but also real learnings as to making sure that we increase awareness for Trodelvy early on. And so from a U.S. standpoint, we actually did see strong demand growth quarter-over-quarter. We saw it at about 7%. Unfortunately, it got impacted by unfavorable onetime pricing dynamics. And so that's where you see the net revenues are only up 1%.

謝謝，馬修。我是喬安娜。讓我來補充一些背景資訊。正如你從全球視角所見，我們整體實現了強勁成長。正如你所提到的，這其中很大一部分是成長來自歐洲市場，特別是法國和德國的市場拓展。這兩個市場的銷售成長勢頭強勁，同時也讓我們累積了寶貴的經驗，確保我們能夠儘早提升Trodelvy的品牌知名度。從美國市場來看，我們確實看到了強勁的季度環比需求成長，增幅約為7%。但遺憾的是，由於一次性的不利定價策略，這一增長受到了一定程度的影響。因此，你會看到淨收入只成長了1%。

No concerns on our end because we do see the momentum actually continuing from a share standpoint, and we definitely haven't maximized our opportunity in Trodelvy. Let me tell you, I think that with the incredible overall survival data and the only overall survival data that's shown in this patient population, there's a real opportunity for us to educate and increase the awareness. That's something that we've been tracking really closely is that awareness piece. We got a little slowed down through the COVID era just because offices and cancer centers were quite shut down. But having said that, that picked up really quite nicely over the last 3 to 4 months, and we've expanded our footprint.

我們這邊沒有任何擔憂，因為我們確實看到市場份額的成長勢頭仍在持續，而且我們絕對還沒有充分利用Trodelvy的潛力。我可以告訴你，我認為憑藉其令人難以置信的總體生存率數據（也是目前唯一針對該患者群體公佈的總體生存率數據），我們擁有一個絕佳的機會來開展教育活動並提高公眾認知度。我們一直密切關注公眾認知度的提升。在新冠疫情期間，由於診所和癌症中心大多關閉，我們的發展速度有所放緩。但即便如此，在過去的3到4個月裡，我們的發展勢頭已經顯著增強，並且擴大了我們的業務範圍。

As you may recall, we close to tripled our footprint as of April-May time frame. Now obviously, as you know, when you do that, you're not -- you shouldn't expect results -- I would love it, but you shouldn't expect results within the first month. It usually takes about 6 months or so to start seeing those through, and we should see those come through in the fall as well as additional countries getting reimbursement as you've seen from some of the HTA decisions that have come through and launching in Europe as well. So looking forward to that, but definitely more opportunity ahead and definitely on track to make sure we capture that opportunity.

您可能還記得，我們​​在四、五月的時候業務規模擴大了近三倍。當然，您也知道，這樣做，您不應該期望立即見效——我當然希望如此，但您不應該期望第一個月就看到成效。通常需要大約六個月的時間才能開始看到成效，我們應該會在秋季看到這些成效，同時也會有更多國家獲得報銷，正如您從一些衛生技術評估機構的決定中看到的那樣，我們也將在歐洲推出服務。因此，我們對此充滿期待，未來肯定還有更多機遇，我們一定會全力以赴，確保抓住這些機會。

Our next question comes from David Risinger of SVB Securities.

我們的下一個問題來自SVB證券的David Risinger。

Congrats on the results. So we are obviously in the unfortunate situation in which the government may be working against small molecule innovation in particular, but innovation more broadly. And in light of the possibility that legislation could be signed into law, could you comment on the percentage of Biktarvy net revenue that currently comes from Medicare Part D, just so we have a sense for the potential exposure to Biktarvy drug price controls in 2027?

恭喜取得這樣的成績。顯然，我們目前處境艱難，政府可能正在打壓小分子藥物創新，甚至更廣泛的創新領域。鑑於相關立法有可能最終簽署生效，您能否談談目前Biktarvy淨收入中來自Medicare Part D的比例？這樣我們就能大致了解Biktarvy在2027年可能面臨的藥品價格管制風險。

Johanna, do you want to start with that?

喬安娜，你想從那件事開始嗎？

Yes. Let me start with that. So thanks, David, for your question. I think we touched on a little bit about some of the potential impact. Having said that, from a split government to, I guess, commercial business, it's around -- depending on the different pieces, you're looking at around 40%, 50% versus about a 30% commercial. So that -- what I'm including in that is more your Medicaid/Medicare kind of business, and that's what's kind of playing out to your -- as well as your 340B.

是的，我就先從這裡說起。謝謝大衛的提問。我想我們剛才已經稍微談到了一些潛在的影響。話雖如此，從分裂的政府到商業領域，情況大概是——根據不同的情況，你會看到大約40%到50%的政府部門，而商業部門的佔比約為30%。所以——我這裡指的是像醫療補助/醫療保險這類業務，而這正是對你——以及你的340B計劃——產生影響的。

So I think it's really -- I don't think you should look at it more -- just looking at the percentage of the business. I think it's going to be really interesting to see how all this plays out and when it plays out because it's nothing is really going to impact us for quite some time. I would also suggest that we look at the incredible diversity of our portfolio that we're growing year-on-year and also the geographical diversity as well, which I think will really help mitigate some of these pressures as we go forward. But just from a government business, you are looking probably close to 50% of our total business is in the government setting.

所以我覺得，其實——我覺得你不該再深入研究這個問題了——只要看看業務佔比就行了。我覺得看看這一切最終會如何發展，以及何時發展會很有趣，因為在相當長的時間內，它都不會對我們造成什麼真正的影響。我還建議我們專注於我們業務組合的驚人多樣性，我們每年都在成長，而且業務範圍也十分廣泛，我認為這將有助於我們緩解未來面臨的一些壓力。但就政府業務而言，我們總業務的近50%都來自政府部門。

Great. Thanks, Johanna.

太好了，謝謝你，喬安娜。

Our next question comes from Salveen Richter with Goldman Sachs.

下一個問題來自高盛的薩爾文·里希特。

On HIV, could you just comment on what's keeping the screening and diagnosis below pre-pandemic levels and whether you'd expect a full recovery by year-end? And separately, could you give us a quick update on where you stand with (inaudible) programs?

關於愛滋病，您能否談談是什麼原因導致篩檢和診斷率低於疫情前水準？您是否預計到年底能夠完全恢復？另外，您能否簡單介紹一下您在（聽不清楚）專案方面的進展？

What's the last part? Can you repeat the last part of that question?

最後一部分是什麼？你能再說一次問題的最後一部分嗎？

Where you stand with the long-acting programs when we might see data?

您對長效治療方案的立場是什麼？我們什麼時候才能看到相關數據？

Long-acting data. Yes. Thanks. You cut out a little bit. Apologies. So let me get the first part of that question, and then I'll throw it over to Merdad for the long-acting. So from an HIV screening standpoint, we're about 8% below pre-pandemic levels, so very much in line with kind of where we were pre-2019. From a diagnosis standpoint, what you're seeing is that 30% or so below pre-pandemic, but that's kind of normal. What we've seen in the past, even prior to COVID-19, we're seeing a decline of the diagnosis rate about 10% year-over-year. And so if you think about 3 years, that's about your 30%. So not a huge surprise there and good news, right, as you're thinking about how this HIV market is -- its evolution.

長效數據。是的，謝謝。您剛才漏掉了一點，抱歉。那我先回答問題的第一部分，然後把長效部分的問題交給Merdad。從愛滋病毒篩檢的角度來看，我們目前的篩檢率比疫情前水準低了約8%，與2019年之前的水準基本一致。從診斷的角度來看，目前的篩檢率比疫情前低了約30%，但這很正常。過去，甚至在新冠疫情之前，我們就看到診斷率每年下降約10%。所以，如果算上三年時間，那就是大約30%。所以這並不令人意外，而且是個好消息，對吧？畢竟，愛滋病毒市場正在經歷演變。

What I would like to focus you on, though, is the fact that from a treatment and PrEP standpoint, we are above pre-pandemic levels from a market growth standpoint. And so we feel very confident that the market has recovered. And actually, in PrEP, it's more than recovered. It's actually higher than it's ever been before. So it's actually an expansion of the market. So I think we're in much better shape, and it's taken a little bit more time for treatment. But I think as of Q2, I can honestly say that it is really in a very good place, which is great news for patients.

不過，我想重點強調的是，從治療和暴露前預防（PrEP）的角度來看，我們的市場成長已經超過了疫情前的水平。因此，我們非常有信心市場已經復甦。事實上，PrEP市場不僅復甦了，也達到了前所未有的高度。所以，這其實是一個擴張的市場。因此，我認為我們目前的狀況要好得多，而治療方面則需要更長的時間。但我認為，截至第二季度，我可以坦誠地說，情況確實非常好，這對患者來說是個好消息。

And from a long-acting standpoint, I'd just reiterate with the PDUFA date at the end of the year for lenacapavir in highly treatment experienced, I think that will be the first approval, knock wood, for lenacapavir, and I think that gets us started. After that, remember then we have multiple efforts ongoing. On the PrEP side, we have the PURPOSE studies that are underway. Those are longer-term studies because they're prevention studies, so they'll take a little bit longer to read out. We're looking at few years there, a couple of years, at least for those studies.

從長效治療的角度來看，我想重申一下，lenacapavir 用於治療先前接受過大量治療的患者，其 PDUFA 審批日期定在年底。我認為這將是 lenacapavir 的首個獲批藥物（但願如此），這將為我們打開一個良好的開端。之後，請記住我們還有多項工作正在進行中。在 PrEP 方面，我們正在進行 PURPOSE 研究。這些研究屬於長期研究，因為它們是預防性研究，所以需要更長時間才能得出結果。我們預計這些研究至少需要幾年時間才能完成。

And then on the treatment side, we are -- we have a number of shots on goal there, both oral long-acting as well as subcutaneous long-acting. And there, we are -- we have our own efforts. And you may have noticed we have a number of partner molecules that are coming through our pipeline that could be partnered with lenacapavir for a full treatment regimen that would include lenacapavir. And we continue to work with Merck on the potential for lenacapavir combinations with islatravir. So a lot of different options and a lot of work that's ongoing. And as those progress further along, we'll keep you updated.

在治療方面，我們有許多研發項目正在進行中，包括口服長效製劑和皮下長效製劑。我們在這方面也有自己的努力。您可能已經注意到，我們還有一些正在研發中的合作分子，它們可以與勒那卡帕韋聯合使用，組成包含勒那卡帕韋的完整治療方案。我們也持續與默克公司合作，研究勒那卡帕韋與伊斯拉曲韋聯合用藥的潛力。所以，有很多不同的選擇，也有很多工作正在進行中。隨著這些研究的進展，我們會及時向您報告最新情況。

Our next question comes from Michael Yee with Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

One question but 2 parts. On Trodelvy, maybe Andy or Merdad, you could remind us, have you actually met with FDA on the potential filing? Or what's the holdup there? And how soon is soon to hear back at this? And I think you've already taken a write-down if it was not to be filed, so that would be a different scenario there. But I don't think there'll be any further write-downs if that was the case. And then maybe just comment on lung cancer opportunity. I think in your slide, you say there would be Phase III data in lung cancer next year, and I know that EGS read out next year as well. So just wanted to understand that and your confidence level in lung cancer.

一個問題，但分為兩個部分。關於Trodelvy，Andy或Merdad，你們能否提醒一下，你們是否已經就潛在的申請事宜與FDA進行過會面？或者說，目前進展受阻的原因是什麼？多久才能得到回覆？我想如果最終未能提交申請，你們已經進行了減記，所以情況會有所不同。但我認為，如果真是那樣，應該不會再有進一步的減記了。另外，能否談談肺癌領域的機會？我記得在你們的投影片中提到，明年將會公佈肺癌的III期臨床試驗數據，我知道EGS試驗的數據也將在明年公佈。所以我想了解這方面的訊息，以及你們對肺癌治療的信心程度。

Thanks, Michael. Thanks for the questions. So on Trodelvy, yes, I think nothing has changed from what we said earlier in that we are excited about the data that we generate in TROPiCS-02 and are having ongoing discussions with the agency. And I think if things continue to go well, we will discuss with them the potential for filing. We're cautiously optimistic that, that should be able to continue to go forward, and we'll be able to update you in due course.

謝謝，麥可。感謝你的提問。關於Trodelvy，是的，我認為和我們之前說的沒什麼變化，我們對TROPiCS-02產生的數據感到非常興奮，並且正在與相關機構進行持續的討論。我認為如果一切進展順利，我們會和他們探討提交申請的可能性。我們謹慎樂觀地認為，這件事應該能夠繼續推進，我們會適時向你報告最新情況。

In terms of lung, the primary focus for us in lung is actually the initiation of our Phase III trials in lung. Whether it's the combination trials I referenced earlier with Merck or some of the other combinations that we're doing, we will have some additional data in line that will be coming -- that will be generated over time. But I think the focus should be on those Phase III studies that we'll be reading out. And then maybe, Andy, do you want to address the write-down?

就肺癌而言，我們目前的首要任務是啟動肺癌的III期臨床試驗。無論是先前提到的與默克公司合作的聯合用藥試驗，還是我們正在進行的其他聯合用藥試驗，我們都會陸續公佈一些額外的數據。但我認為，重點應該放在即將發表的III期臨床試驗結果。安迪，你接下來要談談減記的問題嗎？

Sure. Yes, I'd be happy. Michael, thanks for the question. As you recall, we took a conservative approach to the write-down that we took earlier this year as we looked at the potential path forward. We will continue to monitor on a quarterly basis as we have historically and as we should the progress on the program both in lung cancer and in HR+/HER2- breast cancer, both of which we had carrying value on the balance sheet and IPR&D, as you know. So we'll continue to monitor it over time. And each major event, whether it's regulatory discussions or filings or potential approvals, we'll look at that value. Again, we remain confident in the program overall, like where the program is going, and we'll update you as soon as we can on our discussions with the FDA and other regulatory agencies. Thank you.

當然。是的，我很樂意。邁克爾，謝謝你的提問。如你所知，我們今年稍早在進行資產減記時採取了保守的做法，因為我們一直在考慮未來的潛在發展方向。我們將繼續按季度監測肺癌和HR+/HER2-乳癌專案的進展，正如你所知，這兩個專案在我們資產負債表和研發部門都有相應的帳面價值。因此，我們會持續監測。每發生一件大事，無論是監管方面的討論、提交的文件或潛在的審批，我們都會評估其價值。再次強調，我們對整個計畫及其發展方向仍然充滿信心，一旦與FDA和其他監管機構的討論有任何進展，我們會盡快向你報告。謝謝。

Our next question comes from Steve Seedhouse with Raymond James.

下一個問題來自 Raymond James 公司的 Steve Seedhouse。

I had another one on Yescarta just given the strong second line launch. I was wondering how you view the market size or opportunity in second line versus some of the potential upcoming opportunities, ZUMA-23 or -24 populations and outpatients high-risk, first-line and if those could be similar legs up and just how you're thinking about the sort of peak overall opportunity here for Yescarta.

我之前也問過Yescarta，因為它在二線治療市場表現強勁。我想了解您如何看待二線治療的市場規模或機會，以及一些潛在的未來機遇，例如ZUMA-23或ZUMA-24人群、高風險門診患者、第一線治療等。這些新機會是否也能帶來類似的成長？您如何看待Yescarta的整體市場潛力？

Great. Steve, thanks. Christi, over to you.

太好了。史蒂夫，謝謝。克里斯蒂，該你了。

Thank you for the question, Steve. It's really great news for patients right now. Not only is Yescarta being used, but more importantly, we're seeing the class grow. So the use of cell therapy overall is growing, which means instead of the 2 out of 10 patients receiving cell therapy, more are. And that was really -- the impetus for that was really the second-line approval in April. Also all of the data that you saw at ASH with our ZUMA 5-year data -- ZUMA-1 5-year data of overall survival, ZUMA-7 second-line NCCN guidelines, Yescarta being the only Category 1 NCCN product approved for second line. So we do see that this momentum is starting to happen, where it is the only curative potential that physicians have in this grave disease state for patients.

謝謝你的提問，史蒂夫。這對患者來說確實是個好消息。 Yescarta不僅正在被使用，更重要的是，我們看到這類藥物的使用率正在成長。細胞療法的整體使用率正在上升，這意味著接受細胞療法的患者比例從先前的十分之二增加到了更多。而這主要得益於四月Yescarta獲準用於二線治療。此外，你在ASH會議上看到的ZUMA 5年數據——ZUMA-1的5年總生存期數據、ZUMA-7的NCCN二線治療指南數據，以及Yescarta作為唯一獲批用於二線治療的NCCN 1類藥物——也都印證了這一點。因此，我們看到這種發展勢頭正在形成，對於身患重疾的患者而言，細胞療法是醫生目前唯一可能治癒的療法。

So as we look to the future, we're very optimistic that we're trying to get this closer to patients in the outpatient setting, which we are doing through clinical trials. And also some of our authorized treatment centers have already published their data on utilization of Yescarta in the outpatient setting, i.e. Vanderbilt. And as we look at the frontline setting, we're in negotiations right now with the regulatory authorities on exactly how do we define high risk for that trial. So I do think we're finally starting to realize the potential of this curative therapy for patients. And I think that this will continue.

展望未來，我們非常樂觀地認為，我們正在努力讓這種療法更貼近門診患者，而我們正在透過臨床試驗來實現這一目標。此外，我們的一些授權治療中心已經公佈了Yescarta在門診應用的數據，例如范德比爾特大學醫院。在關註第一線治療方面，我們目前正在與監管機構協商，以確定該試驗中高風險族群的具體定義。所以我認為，我們終於開始意識到這種治癒性療法對患者的巨大潛力。而且我相信，這種趨勢將會持續下去。

I will say, though, that this bolus is -- I'll reiterate what I said before. This is bolus, we believe, with the second-line launch of this pent-up demand in the ATC -- patients in the authorized treatment centers, (inaudible) central transplant. So the heavy lifting is over. We have a lot of work to do to educate physicians in the community to ensure that they're referring patients to treatment centers at a timely fashion. So we do have work to do in education, and that's included in the community and also the -- as we launch in multiple countries across the globe. So we do see a steady growth continuing for the next quarters and years to come.

不過，我要重申一下我之前說過的話。我們相信，隨著授權治療中心（ATC）患者（包括中央移植中心的患者）的二線治療方案的推出，這筆資金將用於滿足他們積壓的需求。因此，最艱難的階段已經過去。我們還有很多工作要做，例如教育社區醫生，確保他們及時將患者轉診至治療中心。因此，我們在教育方面還有很多工作要做，這不僅包括社區教育，還包括我們在全球多個國家推出該方案。我們預計未來幾季和幾年內，該方案將持續穩定成長。

Our next question comes from Carter Gould with Barclays.

下一個問題來自巴克萊銀行的卡特·古爾德。

I guess one question, one clarification. First on sort of the CAR T business, can you just talk about the phasing of the supply ramp on the manufacturing side to the extent that might help out this year? Should we think about that really just sort of weighted to year-end? And I guess in answering that, if you could also address sort of the EU manufacturing side, we don't hear much on that. And then on the clarification piece, Johanna, I appreciate the comments on sort of the 50% government for Biktarvy. But could you spell out, I guess, Medicare versus Medicaid there? It's been getting a lot of incoming on that.

我想問一個問題，也想澄清一下。首先是關於CAR-T療法，您能否談談生產方面逐步提高產能的計劃，以及這在今年可能起到的作用？我們是否應該認為產能提升主要集中在年底？在回答這個問題時，您能否也談談歐盟的生產情況，我們很少聽到這方面的消息。另外，關於澄清的問題，Johanna，我很感謝你對Biktarvy公司50%政府補貼的評論。但是，您能否詳細解釋一下，Medicare和Medicaid之間的差異？最近收到了很多關於這方面的諮詢。

Great. Christi, do you want to start and then we'll move to the...

太好了。克里斯蒂，你想先開始嗎？然後我們再進行…

Sure, happy to. So one of the things we're probably particularly proud of is our ability to supply patients both consistently, reliably into the high-quality standards. And that started with El Segundo, California. But to your point, in the EU, Amsterdam is now supplying all of Europe for Yescarta, and they're starting to do Tecartus as well. And so we expect all of the manufacturing for European patients to move to the Amsterdam site by the end of this year.

當然，樂意效勞。我們最引以為傲的一點，就是我們能夠持續、可靠地為患者提供符合高品質標準的藥品。這一切始於加州的埃爾塞貢多。正如您所說，在歐盟，阿姆斯特丹工廠現在負責整個歐洲的Yescarta藥品供應，他們也開始生產Tecartus。因此，我們預計到今年年底，所有針對歐洲患者的藥品生產都將轉移到阿姆斯特丹工廠。

In addition, we just opened the Maryland site, which is the first time we'll actually have automation. One of our -- 1 of 2 modules of automation is up and running in Maryland. And that had -- that Maryland site has allowed us to actually increase our number of slots for patients by 50%. So we feel very confident that we not only can provide patients for what we have today, but what we have in the future and for the future ramp-up that we have plenty of capacity to supply and continue to ensure that we have the high-quality standards.

此外，我們剛剛啟用了馬裡蘭州的診所，這是我們首次真正自動化。我們兩套自動化模組中的一套已經在馬裡蘭州投入運作。馬裡蘭州診所的啟用使我們的患者預約增加了50%。因此，我們非常有信心，不僅能夠滿足目前的患者需求，還能滿足未來的需求，並能應對未來業務成長帶來的挑戰。我們擁有充足的產能，能夠持續確保高標準的服務品質。

The last piece I'll say on supply is we made a decision about 2.5, 3 years ago to bring in viral vector at Oceanside, California. So we're not at the whim of ups and downs, if you will, of viral vector supply. So we have both internal and external ability to ensure that we can keep that continuity for patients and not be disrupted.

關於供應方面，我最後要說的是，大約兩年半到三年前，我們決定在加州奧申賽德引進病毒載體。因此，我們不會受到病毒載體供應波動的影響。我們擁有內部和外部的供應能力，可以確保為患者提供持續的治療，避免中斷。

Thanks, Christi. Over to you, Johanna.

謝謝你，克里斯蒂。接下來就交給你了，喬安娜。

Yes. Thanks. So just to clarify, and thanks for allowing me the opportunity, Carter, and maybe give a little bit more insight to the question. I gave you full numbers on government, but obviously, not all of those numbers get impacted by this reform or what we think might be the reform that we're talking about. And so from a Medicaid standpoint, it's less than 20% of our total business. And so that's really what we should focus on as we think about potential for impact. And again, that impact doesn't happen anytime soon. It's really later in this decade. Dan, did you want to add?

是的，謝謝。卡特，為了澄清一下，也感謝您給我這個機會，或許我可以更詳細地解釋這個問題。我之前已經提供了政府方面的完整數據，但顯然，並非所有數據都會受到這項改革，或者說我們正在討論的改革的影響。就醫療補助計劃而言，它只占我們總業務的不到20%。因此，這才是我們在考慮潛在影響時真正應該關注的重點。而且，這種影響不會很快顯現，要到本世紀末才會出現。丹，你還有什麼要補充的嗎？

I'll just add -- thanks, Carter. I know there's a lot of moving parts here, so I just want to kind of reinforce a couple of things. As you know, there are 3 different aspects of the bill. I mean one is, of course, the Part D reform. And here, a major difference from what occurs today instead of 10% in the catastrophic phase, it goes to 20% in catastrophic phase. It is potentially in the second half of the decade. I think something -- from our perspective, that as we look at our business is quite manageable.

我再補充一點——謝謝，卡特。我知道這裡面有很多細節，所以我只想強調幾點。如你所知，這項法案包含三個不同的面向。首先，當然是D部分改革。與目前的情況相比，一個主要差異在於，災難性階段的稅率將從10%提高到20%。這可能要到本世紀後半葉才會實施。我認為——從我們的角度來看，考慮到我們的業務，這是完全可以應對的。

The second thing is inflation rebate, which I think we would have a low to 0 exposure to. And then the third one is negotiation. I just want to be clear on negotiations. There's a lot of moving parts here. And to Johanna's point, it does not affect the entirety of the government business. Much of the government business is already contracted and under negotiation. And so I really think -- and I'm sure you'll find this with most companies that it's extraordinarily difficult to measure that impact. It also compressed later in the decade. And there's quite a bit of ambiguity about what's products and how and when. And there'll be a lot of discussions should this legislation be passed about the details associated with that.

第二點是通膨退稅，我認為我們受其影響很小甚至為零。第三點是談判。關於談判，我想先說明一點。這裡面牽涉很多面向。正如喬安娜所說，它不會影響政府業務的全部。很多政府業務已經簽訂合同，正在談判中。所以我認為——我相信大多數公司都會有同感——衡量這種影響極其困難。而且，這十年後期的影響也比較集中。關於哪些產品、如何生產、何時生產，都存在著許多模糊之處。如果這項立法獲得通過，將會圍繞相關細節展開大量的討論。

So again, as much as I believe this is not the right thing to do for the industry, I also believe that we've got a very robust underlying business here and that these impacts are not short term at this stage. So yes. And just to be clear, on that 20% figure that's...

所以，儘管我認為這對產業來說並非明智之舉，但我同時也相信我們擁有非常穩健的業務基礎，而且這些影響在現階段並非短期現象。是的。另外，需要澄清的是，關於那20%的數字…

Medicare, Medicaid.

聯邦醫療保險、醫療補助。

Sorry?

對不起？

Medicaid, Medicare.

醫療補助，醫療保險。

Right.

正確的。

Our last question comes from Mohit Bansal with Wells Fargo.

最後一個問題來自富國銀行的莫希特·班薩爾。

So maybe, Johanna, if you can talk a little bit about these Descovy trends in PrEP market. So I know last couple of years, you took a little bit of price decline just to maintain market share. So where do you stand on the pricing? Has it stabilized at this point? And where does the market share of Descovy versus Truvada in this market stand at this point?

喬安娜，你能談談Descovy在PrEP市場的發展趨勢嗎？我知道過去幾年你們為了維持市場佔有率而略微降價。那麼你們現在對價格的看法如何？價格是否已經穩定下來了？ Descovy和Truvada在這個市場上的市佔率目前分別是多少？

Sure. So let me take that one, Mohit. The -- so basically from a market share standpoint, we basically -- we lost maybe a point or so over the last year, but we're at about 44% market share for Descovy in PrEP, which I think is pretty incredible if you think about the generic competition that we've been facing. The balance of that market share right now is pretty much all Truvada, Truvada generics. There's about less than 1% if you think of Apretude, as you think about new entrants in the marketplace. So it's really a mix of Descovy for PrEP as well as Truvada genericization.

當然。那我來回答這個問題，莫希特。基本上，從市場佔有率的角度來看，我們過去一年可能損失了一個百分點左右，但Descovy在PrEP領域的市佔率約為44%，考慮到我們面臨的仿製藥競爭，我認為這相當不錯。目前剩餘的市佔率幾乎全部被Truvada及其仿製藥佔據。如果算上Apretude這種新進入市場的藥物，市佔率約不到1%。所以，PrEP市場的份額其實就是Descovy和Truvada仿製藥共同作用的結果。

The -- from a pricing standpoint, what you were referring to, the -- it has stabilized, although the rebates are definitely higher than what we were doing in the past just because there's choice now. And we are really trying to ensure that Descovy is a choice for physicians when people at risk need something. And so we want to make sure that, that's an option for them and making sure that we have the best on the marketplace with if you think about the bone and renal safety profile that Descovy can offer.

從定價角度來看，您提到的問題——價格已經趨於穩定，儘管由於現在有更多選擇，回扣肯定比以前高。我們正努力確保當高風險族群需要治療時，Descovy 能成為醫生的首選。因此，我們希望確保它能成為他們的選擇，並確保我們提供市場上最好的產品，尤其是在骨骼和腎臟安全性方面，Descovy 無疑是最佳選擇。

So that's really why we've been playing in that field, and that's why it's come -- it's put a little bit of more pressure on the commercial fund, specifically on the rebate front. And so I think that's stabilizing, but every year is a new year as we enter negotiations, so more to come as we go into 2023. But for 2022, we're in good shape. And we're also leveraging the incredible market growth for prevention that's been playing out. So all the things are very positive things for Descovy in prevention as well as for people at risk.

所以，這就是我們一直在這個領域努力的原因，也是為什麼它給商業基金，特別是退款方面，帶來了一些壓力。我認為情況正在趨於穩定，但每年都是新的一年，因為我們都必須進行談判，所以進入2023年後還會有更多變化。但就2022年而言，我們情況良好。我們也正在利用預防領域令人矚目的市場成長。因此，所有這些對Descovy的預防工作以及高風險族群來說都是非常積極的。

Great. So thanks so much for joining today. I just want to thank you again. I just want to reinforce what a strong quarter this was and thank the team for really significant momentum, I would say, in our business. You saw our first quarter or second quarter. We're committed to delivering quarter after quarter on this on both the commercial execution of the pipeline side and really excited about where we stand right now and where we're heading.

太好了。非常感謝您今天能來。我再次感謝大家。我想強調一下，這個季度業績非常強勁，感謝團隊為我們的業務帶來了顯著的成長動能。您也看到了我們第一季或第二季的表現。我們致力於在產品線的商業執行方面，每個季度都保持這樣的勢頭，並且對我們目前的狀況和未來的發展方向感到非常興奮。

With that, I'll turn it over to Jacquie for some closing comments.

接下來，我將把發言權交給傑奎琳，請她做一些總結性發言。

Thanks, Dan, and thank you all for joining us today. Please do feel free to reach out to Investor Relations if you have any follow-up questions on the quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the year. Thank you.

謝謝丹，也謝謝各位今天蒞臨。如果您對本季有任何後續問題，請隨時聯絡投資者關係部門。感謝您一直以來對吉利德的關注，我們期待今年持續向您報告公司進度。謝謝。

That concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您可以掛斷電話了。