吉利德科學 (GILD) 2019 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences First Quarter 2019 Earnings Conference Call. My name is Jonathan, and I will be your conference operator today. (Operator Instructions) And as a reminder, this conference call is being recorded.

    女士們、先生們,感謝各位的耐心等待,歡迎參加吉利德科學公司2019年第一季財報電話會議。我叫喬納森,今天我將擔任你們的會議接線生。(操作員說明)再次提醒,本次電話會議正在錄音。

  • I would now like to turn the call over to Sung Lee, Vice President of Investor Relations. Please go ahead.

    現在我將把電話交給投資人關係副總裁李成先生。請繼續。

  • Sung Lee - VP of IR

    Sung Lee - VP of IR

  • Thank you, Jonathan, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the first quarter 2019. The press release and detailed slides are available on the Investor Relations section of the Gilead website.

    謝謝你,喬納森,大家下午好。今天股市收盤後不久,我們發布了 2019 年第一季獲利結果的新聞稿。新聞稿和詳細幻燈片可在吉利德公司網站的投資者關係部分查看。

  • The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer; Robin Washington, Executive Vice President and Chief Financial Officer; Laura Hamill, Executive Vice President, Worldwide Commercial Operations; and John McHutchison, Chief Scientific Officer and Head of Research and Development.

    今天電話會議的發言人有:董事長兼執行長丹尼爾·奧戴;執行副總裁兼財務長羅賓·華盛頓;全球商業營運執行副總裁勞拉·哈米爾;以及首席科學官兼研發主管約翰·麥克哈奇森。

  • Before we begin with our prepared comments, let me remind you that we will be making forward-looking statements, including plans and expectations with respect to products, product candidates, financial projections and the use of capital, 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. A description of these risks can be found in our latest SEC disclosure documents and recent press releases.

    在我們開始發表準備好的評論之前,請允許我提醒各位,我們將發表一些前瞻性聲明,包括有關產品、候選產品、財務預測和資本使用的計劃和預期,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存在重大差異。有關這些風險的描述,請參閱我們最新的美國證券交易委員會披露文件和近期發布的新聞稿。

  • In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call. 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 as well as on the Gilead website.

    此外,吉利德不承擔更新本次電話會議中任何前瞻性聲明的義務。我們將使用非公認會計準則財務指標來幫助您了解公司的基本業務表現。GAAP 與非 GAAP 的調整表已在盈利新聞稿以及吉利德網站上提供。

  • I will now turn the call over to Dan.

    現在我將把通話交給丹。

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Thank you, Sung, and good afternoon, everyone. I'm really pleased to join all of you today for my first earnings call at Gilead. Robin, Laura and John will take you through the key highlights of the quarter, but I'd like to share -- and start by sharing some of the perspectives that I gained since arriving here in March.

    謝謝宋,大家午安。今天我非常高興能和大家一起參加我在吉利德的第一次財報電話會議。Robin、Laura 和 John 將帶您了解本季度的主要亮點,但我想分享一下——首先分享我自三月來到這裡以來所獲得的一些觀點。

  • As many of you know, when I made the decision to join Gilead, I was drawn to the potential that I saw to build on the legacy of transforming care for people with serious illnesses in a company that has a deep commitment to patients and science. I've now had a chance to see the extent of that potential up close. Let me share some of what I've observed, the areas that I focused on up until now and a few thoughts on what you can expect next.

    正如你們許多人所知,當我決定加入吉利德時,我被其潛力所吸引,我看到了在一家對患者和科學有著深厚承諾的公司裡,能夠延續其改變重症患者護理的傳統。現在我有機會近距離地看到了這種潛力的程度。讓我分享一下我的一些觀察、我目前為止關注的領域,以及我對接下來可以期待的一些想法。

  • The first thing I'll say is that it's been really exciting to see the scientific strength from the perspective of being inside the company. I've taken part in a series of deep dives into the R&D programs in each of our therapeutic areas. This includes spending time at Kite to dig into our work in cell therapy.

    首先我想說的是,從公司內部的角度來看,看到公司的科學研究實力真的令人興奮。我參與了一系列對我們各個治療領域的研發項目的深入研究。這包括在 Kite 花時間深入了解我們在細胞療法方面的工作。

  • I'm excited about the progress that we're making in inflammation, and with the results of FINCH 1 and FINCH 3, the studies that were announced at the end of March. John will walk you through the detailed study results later in this call, but I just want to express my enthusiasm for this work as we mobilize the organization for the launch of filgotinib, a medicine that will be a significant step forward for patients with rheumatoid arthritis. Inflammation is one of the 3 emerging areas for us, and we anticipate that filgotinib will be an important future growth driver.

    我對我們在發炎領域的進展感到興奮,尤其是 FINCH 1 和 FINCH 3 這兩項研究的結果,它們已於 3 月底公佈。約翰稍後會在本次通話中向大家詳細介紹研究結果,但我只想表達我對這項工作的熱情,因為我們正在動員組織力量推出filgotinib,這種藥物將是類風濕性關節炎患者的一大進步。發炎是我們三大新興領域之一,我們預期 filgotinib 將成為未來重要的成長驅動力。

  • As I deepen my understanding of Gilead's therapeutic areas, I've had the pleasure of participating in 2 scientific congresses, beginning with CROI or the Conference on Retroviruses and Opportunistic Infections. And here, I had the opportunity to watch as we shared the promising results from DISCOVER -- from the DISCOVER study of Descovy for PrEP. More recently, I attended the International Liver Congress in Vienna, where we presented data from across our liver disease programs and had the chance at both of these conferences to meet with key thought leaders and get their perspectives on our R&D programs.

    隨著我對吉利德治療領域的了解不斷加深,我有幸參加了兩次科學大會,第一次是逆轉錄病毒和機會性感染會議 (CROI)。在這裡,我有機會見證了我們分享 DISCOVER 研究的令人鼓舞的結果——該研究旨在評估 Descovy 在 PrEP 中的應用。最近,我參加了在維也納舉行的國際肝病大會,我們在會議上展示了我們肝病計畫的數據,並有機會在這兩次會議上與重要的思想領袖會面,了解他們對我們的研發計畫的看法。

  • During my first 2 months, I've also begun to get to know our shareholders and to understand their perspectives. These conversations have helped me understand the external view of Gilead, and this feedback will help inform the decisions that I make to shape the organization and position Gilead for the future.

    在最初的兩個月裡,我也開始了解我們的股東,並且理解他們的觀點。這些對話幫助我了解了外界對吉利德的看法,這些回饋將有助於我做出塑造組織和為吉利德的未來定位的決策。

  • As I've settled into my new role, I've been greatly impressed with the people at Gilead and the extent of talent across the organization. I spent a lot of time talking to groups and individuals, and it's great to meet so many really smart, passionate and thoughtful people.

    隨著我逐漸適應新的工作崗位,吉利德的員工以及整個組織內的人才儲備都給我留下了深刻的印象。我花了很多時間與團體和個人交談,很高興能遇到這麼多聰明、熱情、有思想的人。

  • I want to close my portion of the call by sharing with you a little bit about what you can expect from me and when. In terms of immediate priorities, broadly speaking, I'm looking first at 3 key areas: number one, strengthening the pipeline, both internal programs and corporate development opportunities; number two is ensuring optimal commercial delivery, both on our current medicines and those that we're getting ready to launch; and number three, the organizational piece, ensuring that we have the right people in the right roles and that they are well-equipped for success. I want to make sure we tap into the talent at all levels of the company.

    在結束本次通話前,我想和大家分享你們可以從我這裡獲得什麼以及何時獲得什麼。就眼下優先事項而言,總的來說,我首先關註三個關鍵領域:第一,加強研發管線,包括內部專案和企業發展機會;第二,確保最佳的商業交付,包括我們目前的藥物和即將推出的藥物;第三,組織方面,確保我們有合適的人在合適的職位上,並且他們具備成功所需的一切條件。我想確保我們能夠充分挖掘公司各個層級的人才。

  • In my early days, one area of pressing need has been working to better understand the work we are doing at Kite, identifying what it needs for short- and long-term success in cell therapy. I wanted to take some swift decisions here. And at the end of March, we announced internally that Kite would become a separate business unit. We've initiated a search for a CEO of Kite. And once appointed, that individual will report to me and will have full accountability for all aspects of cell therapy. I believe that providing Kite with this degree of autonomy will foster agility, innovation and entrepreneurialism.

    在我職業生涯的早期,一個迫切需要解決的問題是更好地了解我們在 Kite 所做的工作,確定它在細胞療法方面取得短期和長期成功需要什麼。我想在這裡迅速做出一些決定。3月底,我們內部宣布Kite將成為一個獨立的業務部門。我們已啟動Kite公司執行長的遴選工作。一旦任命,該人員將向我匯報工作,並對細胞治療的各個方面負全部責任。我認為,給予 Kite 這種程度的自主權將促進其敏捷性、創新性和創業精神。

  • Cell therapy is a critical piece of the puzzle with regards to the long-term future of oncology and a critical element of Gilead's long-term strategy, helping us to build on a legacy of transformational medicines. Between now and the end of the year, I will also have a series of meetings with the leadership team and the board to shape our long-term strategy and vision for the future of Gilead. I anticipate that later this year, I'll be in a position to begin sharing more with all of you.

    細胞療法是腫瘤學長期發展中至關重要的一環,也是吉利德長期策略的關鍵要素,它幫助我們延續了變革性藥物的傳統。從現在到年底,我也會與領導團隊和董事會舉行一系列會議,以製定吉利德的長期策略和未來願景。我預計今年晚些時候,我將能夠開始與大家分享更多資訊。

  • Finally, I'd like to thank all the people who have contributed to the excellent progress my colleagues will outline today: Gilead's 11,000 employees, our partners, the scientific community and the patients who take part in our clinical trials. I'm excited to see what we can achieve together in the months and years ahead.

    最後,我要感謝所有為我同事們今天將要概述的卓越進展做出貢獻的人:吉利德的 11,000 名員工、我們的合作夥伴、科學界以及參與我們臨床試驗的患者。我很期待在未來的幾個月和幾年裡,我們能夠共同達成怎樣的成就。

  • Before I turn the call over to Robin, I would like to acknowledge the news we shared earlier this week regarding her retirement from her role as CFO. Over the past 2 months, I've come to know Robin as an exceptional and talented leader. This is a transition that I know she has contemplated for some time, and while I had hoped to have the opportunity to work with her for longer, she has my full support.

    在將電話交給 Robin 之前,我想先提及我們本週稍早分享的關於她從財務長職位退休的消息。在過去的兩個月裡,我逐漸意識到羅賓是一位傑出而有才華的領導者。我知道她已經考慮這個轉變有一段時間了,雖然我希望有機會和她一起工作更長時間,但我會全力支持她。

  • I'm grateful to Robin for agreeing to stay at Gilead through March 1, 2020, to see us through the completion of the reporting of the company's 2019 financial results.

    我感謝 Robin 同意留在吉利德公司工作到 2020 年 3 月 1 日,幫助我們完成公司 2019 年財務表現的報告工作。

  • Thank you, Robin, for your leadership through this period and over the past 11 years.

    羅賓,感謝你在這段時期以及過去11年的領導。

  • I'll now turn the call over to you.

    現在我把電話交給你。

  • Robin L. Washington - CFO & Executive VP

    Robin L. Washington - CFO & Executive VP

  • Thank you, Dan, and good afternoon, everyone. We are pleased to share our financial results for the first quarter of 2019. Total revenues for the first quarter were $5.3 billion, with non-GAAP diluted earnings per share of $1.76. This compares to revenues of $5.1 billion and non-GAAP earnings per share of $1.48 for the same period last year.

    謝謝你,丹,大家下午好。我們很高興與大家分享2019年第一季的財務表現。第一季總收入為 53 億美元,非 GAAP 稀釋後每股收益為 1.76 美元。相比之下,去年同期營收為 51 億美元,非 GAAP 每股收益為 1.48 美元。

  • Turning to product sales. Product sales for the first quarter were $5.2 billion, up 4% year-over-year and down 8% sequentially. This is the first quarter in the past 3 years where the company has posted year-over-year growth and it reinforces our belief that the company can grow product sales year-over-year on a full year basis.

    轉向產品銷售。第一季產品銷售額為 52 億美元,年增 4%,季減 8%。這是公司近三年來首次實現同比增長,這更加堅定了我們對公司全年產品銷售額同比增長的信念。

  • In the U.S., product sales for the first quarter were $3.8 billion, up 8% year-over-year and down 15% sequentially. The sequential decline was primarily due to the anticipated inventory drawdown associated with our HIV products, reflective of the seasonal inventory pattern from the fourth quarter to the first quarter.

    在美國,第一季產品銷售額為 38 億美元,年增 8%,季減 15%。環比下降主要是由於我們 HIV 產品相關的預期庫存減少,反映了從第四季度到第一季的季節性庫存模式。

  • As expected, our HIV payer mix moved more toward public payers, which also contributed to the sequential decline. Combined, inventory and payer mix contributed an estimated $400 million to the sequential decline.

    正如預期的那樣,我們的 HIV 支付方結構更多地轉向了公共支付方,這也導致了環比下降。庫存和付款方結構綜合起來,估計造成了 4 億美元的環比下降。

  • Turning to Europe. Product sales for the first quarter were $882 million, down 12% year-over-year and up 8% sequentially. Sequentially, the increase was due to an unfavorable accounting adjustment related to statutory revenue clawback reserves recorded in Q4. Without these Q4 adjustments, product sales would have been flat.

    轉向歐洲。第一季產品銷售額為 8.82 億美元,年減 12%,季增 8%。從季度來看,成長是由於第四季度記錄的法定收入追回準備金相關的不利會計調整所致。如果沒有第四季的這些調整,產品銷售將持平。

  • On a year-over-year basis, the decline was driven by lower HCV sales due to lower patient starts and competitive dynamics and the broader availability of generic HIV products in 2019.

    與前一年相比,下降的原因是 HCV 銷售量下降,這是由於患者數量減少、競爭加劇以及 2019 年 HIV 仿製藥的普及所致。

  • Now turning to expenses. Non-GAAP R&D expenses were $871 million for the first quarter, up 7% compared to the same period last year, primarily due to higher investments to support our cell therapy programs.

    現在來說說費用。第一季非GAAP研發費用為8.71億美元,比去年同期成長7%,主要原因是加大了對細胞療法計畫的投資。

  • Non-GAAP SG&A expenses were $962 million for the first quarter, up 9% compared to the same period last year, primarily due to higher promotional expenses in the U.S. and expenses associated with the expansion of Gilead's products in Europe and Japan.

    第一季非GAAP銷售、一般及行政費用為9.62億美元,比去年同期成長9%,主要原因是美國促銷費用增加以及吉利德產品在歐洲和日本擴張的相關費用。

  • Our non-GAAP effective tax rate in the first quarter was 16.7% compared to 22.8% in the same period last year, due to a $0.09 per share favorable tax settlement. Note that this settlement was reflected in the full year 2019 non-GAAP effective tax rate guidance of 20% to 21%, as previously provided.

    由於每股 0.09 美元的有利稅收結算,我們第一季的非 GAAP 實際稅率為 16.7%,而去年同期為 22.8%。請注意,和解方案已反映在先前公佈的 2019 年全年非 GAAP 有效稅率指引值 20% 至 21% 中。

  • Moving to the balance sheet. During the first quarter, we generated $1.4 billion in cash from operations and ended the quarter with $30.1 billion in cash and investments. We repaid $750 million of debt borrowed in connection with our acquisition of Kite. We paid cash dividends of $817 million, and we repurchased 12 million shares of stock for $834 million. As a reminder, the majority of our stock compensation awards are issued in the first quarter.

    接下來查看資產負債表。第一季度,我們從經營活動中獲得了 14 億美元的現金,季度末現金和投資總額為 301 億美元。我們償還了與收購 Kite 相關的 7.5 億美元債務。我們支付了 8.17 億美元的現金股息,並以 8.34 億美元的價格回購了 1,200 萬股股票。再次提醒,我們大部分的股票獎勵都在第一季發放。

  • 2019 is progressing consistent with our expectations as we enter the second quarter of our fiscal year, and we are reiterating our full year guidance, which can be found on Slide 18 in the earnings results presentation.

    2019 年的進展與我們的預期一致,我們已進入本財年的第二季度,我們重申全年業績指引,詳情請見收益報告第 18 頁。

  • As we mentioned in the previous earnings call, our SG&A guidance included funding to support commercial launch activities for NASH. Given the results of STELLAR Phase III studies, SG&A funding for these activities will not be utilized in 2019.

    正如我們在上一次財報電話會議上提到的,我們的銷售、一般及行政費用指導包括為支持 NASH 的商業上市活動提供資金。鑑於 STELLAR III 期研究的結果,2019 年將不會使用 SG&A 資金來進行這些活動。

  • We do believe there may be opportunities to enhance launch readiness for filgotinib that we are monitoring. As such, we will revisit SG&A and our other guidance assumptions midyear and provide you with an update during our Q2 call.

    我們相信,或許有機會提高filgotinib的上市準備度,我們正在密切關注這些機會。因此,我們將在年中重新審視銷售、一般及行政費用和其他業績指引假設,並在第二季電話會議上向您提供最新資訊。

  • We remain committed to vigilant expense management and ensuring that we retain industry-leading operating margins.

    我們將繼續嚴格控製成本,確保維持業界領先的營業利潤率。

  • I will now turn the call over to Laura.

    現在我將把通話轉給勞拉。

  • Laura Hamill - EVP of Worldwide Commercial Operations

    Laura Hamill - EVP of Worldwide Commercial Operations

  • Thank you, Robin. Good afternoon, everyone. I will provide an update on our commercial performance during the first quarter and share highlights from markets around the world.

    謝謝你,羅賓。大家下午好。我將報告我們第一季的商業業績,並分享來自世界各地市場的亮點。

  • Beginning with HIV. We continue to see double-digit revenue growth on a year-over-year basis, led by uptake of our Descovy-based regimen and growing use of Truvada for PrEP.

    從愛滋病毒開始。我們繼續保持兩位數的年收入成長,這主要得益於基於 Descovy 的治療方案的推廣以及 Truvada 在 PrEP 中的日益普及。

  • In the U.S., HIV revenue was $2.8 billion in the first quarter, up 19% year-over-year and down 17% quarter-over-quarter. As Robin noted, the sequential change reflects the anticipated inventory drawdown and payer mix in the first quarter. This trend is a typical pattern that we see between Q1 and the preceding Q4.

    在美國,第一季 HIV 收入為 28 億美元,年增 19%,季減 17%。正如 Robin 指出的那樣,這一環比變化反映了第一季預期的庫存減少和付款方組合變化。這種趨勢是我們在第一季和前一個第四季之間經常看到的典型模式。

  • Underlying prescription demand remains robust, growing 12% year-over-year. We continue to see excellent adoption of Biktarvy. It has become the top-selling product in the U.S. and generated $739 million in revenue. It remains the #1 prescribed regimen in both treatment-naïve and switch patients.

    處方藥的潛在需求依然強勁,較去年同期成長 12%。我們持續看到Biktarvy的良好普及率。它已成為美國最暢銷的產品,創造了 7.39 億美元的收入。它仍然是初治患者和轉診患者的首選治療方案。

  • Approximately 80% of Biktarvy's U.S. prescriptions come from switches, with about 25% coming from Genvoya and 25% coming from dolutegravir-based regimens. Overall, Descovy-based regimens continue to gain share and now account for approximately 80% of Gilead's total U.S. treatment prescription volume. In Europe, total HIV revenue was $569 million in the first quarter, down 7% year-over-year and up 11% quarter-over-quarter. The year-over-year decline was driven by the broad availability of generic versions of Truvada across the EU. The decline, however, is moderating as we continue to see rapid uptake of our Descovy-based product, which now account for almost 80% of our total HIV revenue in Europe in the first quarter.

    Biktarvy 在美國的處方中,約 80% 來自藥物轉換,約 25% 來自 Genvoya,25% 來自基於多替拉韋的治療方案。總體而言,基於 Descovy 的治療方案市佔率持續成長,目前約佔吉利德在美國治療處方總量的 80%。在歐洲,第一季 HIV 相關收入總額為 5.69 億美元,年減 7%,季增 11%。年比下降的原因是 Truvada 的仿製藥在歐盟範圍內廣泛普及。然而,隨著我們基於 Descovy 的產品繼續快速普及,這種下滑趨勢正在放緩,該產品目前占我們第一季歐洲 HIV 總收入的近 80%。

  • Biktarvy is now available in Germany, France and Spain. We anticipate launching in the U.K. and Italy midyear. We are encouraged by the strong uptake of Biktarvy across all markets where we have launched.

    Biktarvy現已在德國、法國和西班牙上市。我們預計將於年中在英國和義大利推出。Biktarvy 在我們推出的所有市場都獲得了強勁的市場認可,這讓我們倍感鼓舞。

  • In 2018, we launched Biktarvy in Germany in June and France in November. In both markets, Biktarvy has quickly become the #1 regimen for naïve and switch patients.

    2018 年 6 月,我們在德國推出了 Biktarvy;同年 11 月,我們在法國推出了 Biktarvy。在這兩個市場,Biktarvy 已迅速成為初治患者和轉診患者的首選治療方案。

  • As you will recall, in Japan, we acquired rights to certain products from our HIV franchise from our marketing partner Japan Tobacco at the beginning of the year. We subsequently received approval for Biktarvy in March and launched earlier this quarter.

    您應該還記得,今年年初,我們從行銷合作夥伴日本菸草公司獲得了我們 HIV 特許經營權中的某些產品的權利。我們隨後在三月獲得了 Biktarvy 的批准,並在本季初正式推出。

  • Now moving to prevention. Use of Truvada for PrEP continues to grow in the United States. As we work to educate at-risk individuals and treating physicians, we estimate more than 200,000 people were taking Truvada for PrEP at the end of Q1. These estimates reflect an external industry-wide restatement from IQVIA, a source that we use to quantify Truvada for PrEP use.

    現在轉向預防。在美國,使用 Truvada 作為暴露前預防藥物的情況持續成長。在我們努力教育高風險族群和治療醫生的同時,我們估計在第一季末有超過 20 萬人服用 Truvada 進行 PrEP。這些估計值反映了 IQVIA 提供的外部產業範圍內的重新評估,我們使用該來源來量化 Truvada 在 PrEP 中的使用。

  • On a like-for-like basis, we saw 28% year-over-year growth. We were also very pleased to see the outstanding results from the discovery (sic) [DISCOVER] trial presented at CROI.

    以同等條件計算,我們實現了 28% 的年增長。我們也非常高興地看到在 CROI 上公佈的發現試驗 (DISCOVER) 的出色結果。

  • If approved, we believe Descovy for PrEP will bring a meaningful benefit to at-risk individuals, where we have been seeing increase in persistency of use.

    如果獲得批准,我們相信 Descovy for PrEP 將為高風險族群帶來顯著益處,我們已經看到他們的使用堅持性有所提高。

  • Now turning to HCV. U.S. product sales for the first quarter were $393 million, down 33% year-over-year and down 4% quarter-over-quarter. The year-over-year U.S. decline was primarily driven through competitive dynamics, including an alignment of the Medicare and commercial pricing at the start of 2019 and lower patient starts.

    現在來說說丙型肝炎。美國第一季產品銷售額為 3.93 億美元,年減 33%,季減 4%。美國較去年同期下降的主要原因是競爭動態,包括 2019 年初醫療保險和商業定價的統一性以及患者起始數量的減少。

  • Sequentially, revenues in Q1 were positively impacted by the timing of a Department of Corrections order, which was originally anticipated later in the year. Over the full year, HCV revenue expectation for 2019 remain unchanged.

    從季度環比來看,第一季的收入受到了懲教部門一項命令的及時影響,該命令原本預計在今年稍後發布。2019 年全年 HCV 收入預期維持不變。

  • Revenue for our HCV generics sold by our separate subsidiary Asegua Therapeutics is in line with our expectations. Sales in the first quarter included some wholesaler inventory stocking. Asegua is continuing negotiations with payers, and as we previously communicated, we anticipate Asegua's launch will continue to gain momentum in the second half of 2019.

    我們旗下子公司 Asegua Therapeutics 銷售的 HCV 仿製藥的收入符合我們的預期。第一季的銷售額包含部分批發商的庫存。Asegua 正在繼續與支付方進行談判,正如我們之前所溝通的那樣,我們預計 Asegua 的推出將在 2019 年下半年繼續獲得發展勢頭。

  • In Europe, HCV product sales for the first quarter were $203 million, down 25% from the prior year due to declining patient starts and 8% quarter-over-quarter. The quarter-over-quarter increase was primarily due to Q4 accounting adjustment that Robin mentioned earlier.

    在歐洲,第一季丙型肝炎產品銷售額為 2.03 億美元,由於患者數量下降,比上年同期下降 25%,環比下降 8%。季度環比成長主要是由於羅賓之前提到的第四季度會計調整。

  • We are continuing to see favorable share trends, particularly with Epclusa in France, Spain and the U.K. We launched Epclusa in Japan in late February, and we believe this has the potential to bring meaningful benefit to patients with HCV.

    我們持續看到有利的市場份額趨勢,尤其是在法國、西班牙和英國的 Epclusa。我們在 2 月下旬在日本推出了 Epclusa,我們相信它有可能為 HCV 患者帶來實質的益處。

  • Now turning to Yescarta. The commercial performance continues to meet our expectations of a steady adoption. Worldwide sales were $93 million during the first quarter, up 19% quarter-over-quarter. Since launch, more than 1,500 patients have been treated with Yescarta, including patients for commercial market and clinical trials. This is an important milestone for our cell therapy business.

    現在轉向 Yescarta。商業表現持續符合我們預期,實現了穩定成長。第一季全球銷售額為 9,300 萬美元,季增 19%。自上市以來,已有超過 1500 名患者接受了 Yescarta 治療,其中包括商業市場和臨床試驗的患者。這是我們的細胞治療業務的一個重要里程碑。

  • In the U.S., hospitals continue to learn how to operationalize CAR T therapy and physician awareness of Yescarta's data continues to improve.

    在美國,醫院仍在不斷學習如何實施 CAR-T 療法,醫生對 Yescarta 數據的認識也不斷提高。

  • Our efforts remain focused on educating providers about the profile of Yescarta, working with centers on operational setup and engaging with community oncologists to identify patients for whom Yescarta is appropriate. We're beginning to see benefits of all of these efforts.

    我們仍致力於向醫療服務提供者普及 Yescarta 的特點,與各中心合作進行營運設置,並與社區腫瘤學家合作,以確定哪些患者適合使用 Yescarta。我們開始看到這些努力所帶來的益處。

  • Additionally, we continue to engage with Centers for Medicare & Medicaid Services, or CMS, and other stakeholders as we work to improve Medicare reimbursement and access.

    此外,我們將繼續與醫療保險和醫療補助服務中心(CMS)以及其他利害關係人合作,努力改善醫療保險的報銷和取得途徑。

  • Last week, CMS released the 2020 proposed rule for Medicare inpatient prospective payment, which contains an increase and the new technology add-on payment. The proposal is currently open for public comment through the end of June. This is a positive step. And while we believe more needs to be done, we are very encouraged by the progress.

    上週,CMS 發布了 2020 年 Medicare 住院預付制擬議規則,其中包括增加費用和新的技術附加支付。該提案目前正在公開徵求公眾意見,截止日期為6月底。這是一個積極的進展。雖然我們認為還需要做更多的工作,但我們對所取得的進展感到非常鼓舞。

  • In Europe, we are focused on getting sites certified. It's early days for Yescarta in Europe, but we have already achieved reimbursement in countries such as Germany, France and U.K. Across Europe, we are continuing to build awareness about the therapy.

    在歐洲,我們專注於為網站進行認證。Yescarta 在歐洲尚處於起步階段,但我們已在德國、法國和英國等國家獲得了健保報銷。在整個歐洲,我們正在繼續提高人們對這種療法的認識。

  • Finally, I'd like to acknowledge the strong closing performance of our cardiopulmonary team as we lost exclusivity for Ranexa and Letairis. Letairis and Ranexa revenue totaled $352 million for the quarter. As expected, we saw generic versions of Ranexa enter the market during the quarter, leading to a drop in revenue. We anticipated generic competition for Letairis during the second quarter as FDA approved the single, shared REMS in March.

    最後,我要稱讚我們心肺團隊在收官階段的出色表現,因為我們失去了 Ranexa 和 Letairis 的獨家經銷權。Letairis 和 Ranexa 本季總營收為 3.52 億美元。正如預期的那樣,本季度我們看到了 Ranexa 的仿製藥進入市場,導致收入下降。我們預計在第二季 Letairis 將面臨仿製藥的競爭,因為 FDA 在 3 月批准了單一共享的 REMS。

  • The year is off to a great start. I'd like to thank the teams around the world for their incredible efforts. With a continued focus on our outstanding portfolio of products, we are making wonderful progress.

    今年開局非常順利。我要感謝世界各地的團隊所付出的巨大努力。我們持續專注於我們卓越的產品組合,並取得了令人矚目的進展。

  • Now I'd like to turn the call over to John.

    現在我想把電話交給約翰。

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • Thank you, Laura, and thank you, everyone, for joining us today. Let me start by saying that this has been another important quarter for the R&D part of our organization, and I remain excited about our ongoing program. So far this year, we have had 5 Phase III registrational clinical trials read out. I will spend some time discussing these studies and then cover other progress we are making across our pipeline.

    謝謝勞拉,也謝謝各位今天光臨。首先我想說,對於我們組織的研發部門來說,這又是一個重要的季度,我對我們正在進行的專案仍然感到興奮。今年到目前為止,我們已經公佈了 5 項 III 期註冊臨床試驗的結果。我將花些時間討論這些研究,然後介紹我們在產品線中取得的其他進展。

  • In March, we announced additional positive results from our FINCH program in rheumatoid arthritis. FINCH 1 and FINCH 3 Phase III studies of our selective JAK1 inhibitor filgotinib in adults with moderately to severely active rheumatoid arthritis, each met their respective primary endpoints.

    3月份,我們宣布了FINCH計畫在類風濕性關節炎方面的更多積極成果。FINCH 1 和 FINCH 3 兩項 III 期研究評估了我們選擇性 JAK1 抑制劑 filgotinib 在中度至重度活動性類風濕性關節炎成人患者中的療效,均達到了各自的主要終點。

  • Taken together with the FINCH 2 data reported last year, the 3 FINCH datasets support the potential of filgotinib as an important treatment option across a broad range of patient populations with rheumatoid arthritis.

    結合去年公佈的 FINCH 2 數據,這 3 個 FINCH 數據集支持 filgotinib 作為一種重要的治療選擇,可用於治療各種類風濕性關節炎患者群體。

  • FINCH 3 evaluated filgotinib in combination with methotrexate and as monotherapy in methotrexate-naïve patients. Filgotinib was generally well-tolerated and met the study's primary endpoint in terms of the proportion of patients achieving an ACR20 response at week 24 of treatment.

    FINCH 3 評估了 filgotinib 與甲氨蝶呤聯合治療以及在未接受過甲氨蝶呤治療的患者中作為單藥治療的效果。菲戈替尼整體耐受性良好,在治療第 24 週達到 ACR20 緩解的患者比例方面,達到了研究的主要終點。

  • In addition, the proportion of patients achieving the primary endpoint was significantly higher for filgotinib 200 milligrams plus methotrexate and filgotinib 100 milligrams plus methotrexate compared with methotrexate alone.

    此外,與單獨使用甲胺蝶呤相比,filgotinib 200 毫克加甲氨蝶呤和 filgotinib 100 毫克加甲氨蝶呤達到主要終點的患者比例明顯更高。

  • Key secondary endpoint, specifically ACR50 and ACR70 or deeper responses, and clinical remission rates at week 24, were also significantly higher with filgotinib plus methotrexate compared with patients receiving methotrexate alone.

    與單獨接受甲胺蝶呤治療的患者相比,接受filgotinib聯合甲氨蝶呤治療的患者在第24週時,關鍵次要終點(特別是ACR50和ACR70或更深的緩解率以及臨床緩解率)也顯著更高。

  • Now the FINCH 1 trial evaluated filgotinib compared to adalimumab or placebo on a stable background dose of methotrexate in patients with a prior inadequate response to methotrexate. The safety profile of filgotinib was also consistent with previously reported results. And the study also achieved its primary endpoint for both doses of filgotinib in terms of the proportion of patients achieving an ACR20 response compared to placebo at week 12.

    現在,FINCH 1 試驗評估了在甲氨蝶呤穩定背景劑量下,filgotinib 與 adalimumab 或安慰劑在先前對甲氨蝶呤反應不足的患者中的療效。filgotinib 的安全性也與先前報告的結果一致。該研究在第 12 週時達到 ACR20 緩解的患者比例與安慰劑組相比,兩種劑量的 filgotinib 也達到了主要終點。

  • Similar to results seen throughout our FINCH program, FINCH 1 ACR50 and ACR70 deeper responses were also significantly greater for filgotinib compared with placebo at week 12 for both doses.

    與我們在 FINCH 計畫中觀察到的結果類似,在第 12 週,兩種劑量的 filgotinib 治療組的 FINCH 1 ACR50 和 ACR70 深度緩解率也明顯高於安慰劑組。

  • Across the 3 FINCH trials, we have therefore observed deep, consistent similar to -- responses similar to or higher than other JAK inhibitors and other approved biologic agents. Given the high proportion of patients achieving remission or control of their disease, these responses are encouraging and the safety profile associated with JAK1 specificity continues to be differentiated.

    因此,在 3 項 FINCH 試驗中,我們觀察到了深度、一致的相似反應——與其他 JAK 抑制劑和其他已批准的生物製劑相似或更高。鑑於達到緩解或控制病情的患者比例很高,這些結果令人鼓舞,且與 JAK1 特異性相關的安全性特徵仍在不斷差異化。

  • Based on these data, we will progress the filgotinib rheumatoid arthritis indication filing for regulatory approval in Europe in the second half of this year.

    基於這些數據,我們將在今年下半年推進 filgotinib 治療類風濕性關節炎適應症的申請,以獲得歐洲監管機構的批准。

  • As you know, the MANTA study was requested by the FDA. Now that we have the Phase III data in hand from the 3 FINCH studies, we have initiated a request to have further interactions with the FDA. Following those discussions, we will be able to provide greater clarity on a filing time line in the U.S.

    如您所知,MANTA 研究是 FDA 要求進行的。現在我們已經掌握了 3 項 FINCH 研究的 III 期數據,我們已向 FDA 提出進一步溝通的請求。經過這些討論,我們將能夠更清楚地說明在美國提交申請的時間表。

  • Now turning to HIV. We are pleased with the results from our DISCOVER trial, a Phase III randomized double-blind study of more than 5,000 people evaluating whether once-daily Descovy is as safe and effective as once-daily Truvada at reducing the risk of HIV infection when used as PrEP, or pre-exposure prophylaxis.

    現在來說說愛滋病。我們對 DISCOVER 試驗的結果感到滿意。這是一項 III 期隨機雙盲研究,納入了 5000 多人,旨在評估每日一次的 Descovy 作為 PrEP(暴露前預防)使用時,在降低 HIV 感染風險方面是否與每日一次的 Truvada 一樣安全有效。

  • In a late break oral abstract presented at CROI in Seattle earlier this year, the trial demonstrated that Descovy is non-inferior to Truvada in terms of preventing new HIV infections, with additional statistically significant advantages with respect to bone and renal safety.

    在今年稍早於西雅圖舉行的 CROI 會議上發表的一篇最新口頭摘要中,該試驗表明,Descovy 在預防新的 HIV 感染方面不劣於 Truvada,並且在骨骼和腎臟安全性方面具有額外的統計學顯著優勢。

  • So based on these data, last month, we submitted a supplemental NDA to the FDA for Descovy for the PrEP indication as an potential important new option to prevent HIV infection.

    因此,基於這些數據,上個月,我們向 FDA 提交了 Descovy 用於 PrEP 適應症的補充 NDA,作為預防 HIV 感染的潛在的重要新選擇。

  • If approved, we believe this will help contribute to achieving national and global HIV prevention goals. We submitted a priority review voucher with the filing, and we would anticipate approval in the fourth quarter of 2019.

    如果獲得批准,我們相信這將有助於實現國家和全球愛滋病預防目標。我們在提交申請時附上了優先審查憑證,預計將於 2019 年第四季獲得批准。

  • Moving to liver disease and our broader NASH development program. In the last 2 months, we released top line results from the STELLAR 3 and STELLAR 4 programs, the 2 Phase III studies evaluating the safety and efficacy of our investigational F1 inhibitor selonsertib in patients with -- reaching fibrosis Stage F3 due to NASH and Stage F4, or compensated cirrhosis, due to NASH. Both studies did not meet their primary endpoint at week 48 of a greater than or equal to 1 stage histologic improvement in fibrosis without worsening of NASH.

    接下來談談肝病以及我們更廣泛的 NASH 開發案。在過去的兩個月裡,我們發布了 STELLAR 3 和 STELLAR 4 計畫的主要結果,這兩項 III 期研究評估了我們的在研 F1 抑制劑 selonsertib 在 NASH 導致的纖維化 F3 期和 F4 期(或代償性肝硬化)患者中的安全性和有效性。兩項研究均未達到第 48 週的主要終點,即纖維化組織學改善 1 個階段以上且 NASH 未惡化。

  • Although this is not the outcome we were hoping for, these were important studies to conduct. There's a significant unmet need for patients with advanced fibrosis in this disease. NASH is also a complex biological disease with multiple drivers of the disease, and we believe that combination therapy will likely be necessary to effectively treat most of these patients.

    雖然這不是我們希望的結果,但這些研究非常重要。對於患有這種疾病的晚期纖維化患者而言,存在著巨大的未滿足需求。NASH 也是一種複雜的生物學疾病,其病因多種多樣,我們認為聯合療法可能對於有效治療大多數此類患者是必要的。

  • To that end, the ATLAS trial, a Phase II study evaluating combinations of our investigational compounds in patients with NASH and advanced fibrosis, is expected to read out in the fourth quarter of this year.

    為此,ATLAS 試驗(一項評估我們研究化合物組合治療 NASH 和晚期纖維化患者的 II 期研究)預計將於今年第四季公佈結果。

  • At the International Liver Congress in Vienna last month, we had more than 35 abstracts across NASH, viral hepatitis and primary sclerosing cholangitis. In particular, we presented new data supporting our efforts to develop combination therapies targeting different aspects of NASH; to evaluate the utility of noninvasive tests for the identification of patients living with the disease; and to advance our overall understanding of the complexities and the burden of NASH.

    上個月在維也納舉行的國際肝臟大會上,我們收到了超過 35 篇關於 NASH、病毒性肝炎和原發性硬化性膽管炎的摘要。具體而言,我們展示了新的數據,以支持我們開發針對 NASH 不同方面的聯合療法的努力;評估非侵入性檢測在識別患有該疾病的患者的效用;並增進我們對 NASH 的複雜性和負擔的整體理解。

  • Lastly, as it relates to our NASH program, I would like to highlight 2 recent agreements that will also augment our efforts. A few weeks ago, we announced our intent to enter into clinical collaboration with Novo Nordisk to evaluate the utility of combining their approved GLP-1 drug, semaglutide, with both our FXR agonist, cilofexor, and our ACC inhibitor, firsocostat, for the treatment of patients with NASH.

    最後,關於我們的 NASH 項目,我想重點介紹兩項近期達成的協議,這兩項協議也將加強我們的工作。幾週前,我們宣布打算與諾和諾德公司進行臨床合作,評估將他們已獲批准的 GLP-1 藥物索馬魯肽與我們的 FXR 激動劑西洛芬和 ACC 抑製劑菲索可司他聯合用於治療 NASH 患者的療效。

  • We also announced the strategic collaboration with insitro to discover and develop therapies for patients with NASH. As part of that 3-year collaboration, we will leverage insitro's prior -- proprietary platform, which applies machine learning, human genetics and functional genomics to create disease models for NASH and discover relevant drug targets that have an influence on clinical progression and regression of the disease.

    我們也宣布與 insitro 達成策略合作,共同發現並開發治療 NASH 患者的療法。作為這項為期 3 年合作的一部分,我們將利用 insitro 先前的專有平台,該平台應用機器學習、人類遺傳學和功能基因組學來創建 NASH 疾病模型,並發現對疾病的臨床進展和消退有影響的相關藥物標靶。

  • We therefore have a broad, deep and strong pipeline in NASH, combining both internal programs and multiple external collaborations to advance therapies, and we remain committed to developing effective combination therapies for patients with the disease.

    因此,我們在 NASH 領域擁有廣泛、深入且強大的研發管線,結合內部計畫和多項外部合作來推進治療,我們將繼續致力於為該疾病患者開發有效的聯合療法。

  • Now finally, let's shift gears to cell therapy and the momentum we're seeing there in advancing the next generation of medicine. We're gearing up for ASCO, the American Society of Clinical Oncology, the annual meeting in Chicago in a few weeks. I'm excited by the abstracts we will present. Our anticipated data updates include a presentation of the preliminary result of earlier steroid use with axi-cel in patients with relapsed or refractory large B-cell lymphoma.

    最後,讓我們把話題轉向細胞療法,以及我們在推動下一代醫學發展方面所看到的良好勢頭。我們正在為幾週後在芝加哥舉行的美國臨床腫瘤學會(ASCO)年會做準備。我對我們即將展示的摘要感到興奮。我們預期的數據更新包括展示早期使用類固醇治療復發或難治性大B細胞淋巴瘤患者的初步結果(使用axi-cel)。

  • This study is part of a broader clinical effort to optimize the safety and efficacy profile of Yescarta by evaluating various combination approaches, reaching chemotherapy and revised safety management practices.

    這項研究是更廣泛的臨床工作的一部分,旨在透過評估各種聯合療法、化療和修訂安全管理措施來優化 Yescarta 的安全性和有效性。

  • I'm also pleased to share that we plan to announce top line results of ZUMA-2, our registrational trial of KTE-X19 cell therapy in patients with relapsed/refractory mantle cell lymphoma. Pending positive results, we expect to file for U.S. regulatory approval of KTE-X19 in patients with relapsed/refractory mantle cell lymphoma for this indication by the end of 2019. This would represent the first regulatory submission for X19.

    我也很高興地宣布,我們計劃公佈 ZUMA-2 的主要結果,這是我們針對復發/難治性套細胞淋巴瘤患者進行的 KTE-X19 細胞療法註冊試驗。如果獲得正面的結果,我們預計將於 2019 年底前向美國監管機構申請 KTE-X19 用於治療復發/難治性套細胞淋巴瘤患者的適應症。這將是X19的首次監理申報。

  • As a reminder, KTE-X19 employs the same engineered T cell construct as Yescarta, with a slightly modified manufacturing process to address the specific characteristics of mantle cell lymphoma, acute lymphoblastic leukemia and other diseases where there's a large burden of circulating tumor cells. KTE-X19 was granted breakthrough designation by the FDA. So the application would be considered for expedited review.

    需要提醒的是,KTE-X19 採用與 Yescarta 相同的工程化 T 細胞構建體,但生產過程略有修改,以解決套細胞淋巴瘤、急性淋巴細胞白血病和其他循環腫瘤細胞負荷較大的疾病的特殊性。KTE-X19 獲得了 FDA 的突破性療法認定。因此,該申請將被考慮加快審核。

  • Overall, our commitment to cell therapy is simple. We continue to try to reach more patients in need with Yescarta and to try and optimize the safety and efficacy of the treatment. More broadly, we are focused on creating a path to cure with subsequent generation products that enhance the efficacy and safety of cell therapy for hematological malignancies, and ultimately, solid tumors. We are also advancing allogeneic cell therapies, which could offer significant benefits to patients making time to treat quicker and also more convenient.

    總而言之,我們對細胞療法的承諾很簡單。我們將繼續努力讓更多有需要的患者使用 Yescarta,並努力優化治療的安全性和有效性。更廣泛地說,我們致力於透過後續幾代產品,提高細胞療法對血液惡性腫瘤乃至實體瘤的療效和安全性,從而開闢治癒之路。我們也正在推進同種異體細胞療法,這可以為患者帶來顯著益處,使治療時間更短、更方便。

  • As I look across our R&D organization, including both our earlier and later-stage pipeline, I'm excited about the momentum we have established.

    縱觀我們的研發組織,包括早期和後期研發管線,我對我們所取得的進展感到興奮。

  • In closing, I would like to thank our R&D organization and all of our employees around the world for the hard work and commitment to translating the most important scientific discoveries into the best treatments for patients. So let's now open the call for questions. Operator?

    最後,我要感謝我們的研發部門和世界各地的所有員工,感謝他們為將最重要的科學發現轉化為對患者最好的治療方法所付出的辛勤努力和奉獻精神。現在開始接受提問。操作員?

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from the line of Geoffrey Meacham from Barclays.

    (操作員說明)我們的第一個問題來自巴克萊銀行的傑弗裡·米查姆。

  • Geoffrey Christopher Meacham - MD & Senior Research Analyst

    Geoffrey Christopher Meacham - MD & Senior Research Analyst

  • And Dan, welcome to your first Gilead call.

    丹,歡迎參加你的第一次吉利德電話會議。

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Thanks, Geoff.

    謝謝你,傑夫。

  • Geoffrey Christopher Meacham - MD & Senior Research Analyst

    Geoffrey Christopher Meacham - MD & Senior Research Analyst

  • So I know you just finished the listing tour, but at this point, how much of a strategic priority would you say the NASH portfolio or the hep B portfolio is? And if the answer is high, how aggressive you think you want to be on the BD front to add assets to these 2 categories?

    我知道您剛結束了上市巡展,但就目前而言,您認為 NASH 投資組合或乙肝投資組合的策略優先順序有多高?如果答案是“高”,那麼你認為在業務拓展方面,為了增加這兩類資產,你想採取多積極的策略?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Yes, great. Thanks, Geoff. It gives me a chance to maybe just characterize what I've seen so far. So I've obviously seen, as all of you have, the incredible depth of strength in HIV and in HCV and more broadly, from HCV into liver diseases, where obviously, NASH and hep B are paramount. At the same time, I've had a chance to see the broader portfolio in inflammation, with filgotinib at the lead of a comprehensive life cycle management program, as well as some very interesting partnerships and earlier-stage molecules in inflammation. And likewise, in oncology, of course, with the cell therapy being in a leadership position and all the life cycle managements that go around cell therapy, but also the interesting partnerships around both the biologics and small molecule oncology program.

    是的,太好了。謝謝你,傑夫。這讓我有機會概括一下我目前所看到的景象。所以,正如你們所有人一樣,我顯然也看到了 HIV 和 HCV 的驚人實力,更廣泛地說,從 HCV 到肝臟疾病,其中 NASH 和乙肝顯然是最重要的。同時,我也有機會了解了公司在發炎領域更廣泛的產品組合,其中 filgotinib 處於一項綜合生命週期管理計劃的主導地位,此外還有一些非常有趣的合作關係和發炎領域的早期分子。同樣,在腫瘤學領域,細胞療法當然處於領先地位,圍繞細胞療法的所有生命週期管理,以及圍繞生物製劑和小分子腫瘤學項目的有趣合作關係,也都值得關注。

  • So still early days of digging into that, but I've been impressed by the breadth, I would say, of the portfolio and the partnerships and some of the recent BD activities. Now specifically related to NASH and hep B, I would say that what I've come to understand about NASH is the significant unmet medical need and growing unmet medical need, I would say. And although the results in the first quarter this year didn't turn out as we had expected, it's very clear that this disease needs scientific advancement. It's a heterogeneous disease. There are challenges with diagnosis. And at the same time, Gilead's experts in liver disease make it an area of continued interest for us and I'm particularly interested in the fact that a disease like this with the challenges associated with it may very well require combination therapies. And of course, we'll have some readouts on our combination approaches in the second half of this year, and you heard already from John some of the partnerships that we're entering into in that front.

    雖然目前還處於深入研究的早期階段,但我對投資組合的廣度、合作夥伴關係以及最近的一些業務拓展活動印象深刻。現在具體來說,就 NASH 和B型肝炎而言,我對 NASH 的理解是,存在著巨大的未滿足的醫療需求,而且這種未滿足的醫療需求還在不斷增長。儘管今年第一季的結果不如我們預期,但很明顯,這種疾病需要科學進步。這是一種異質性疾病。診斷方面存在一些挑戰。同時,吉利德在肝病領域的專家也讓我們持續關注這一領域,我特別感興趣的是,像這樣的疾病及其帶來的挑戰很可能需要聯合療法。當然,我們將在今年下半年公佈一些關於我們組合策略的成果,約翰也已經提到了一些我們在這領域正在進行的合作。

  • Hep B, similarly, I mean obviously, we have a treatment for hep B today, which we will continue to focus on. But the opportunity to continue to try to advance the science in hep B, particularly around moving towards a cure, is something that I've been impressed by to see the different scientific approaches that the scientists here at Gilead are looking at. So bottom line, Geoff, is that I think that NASH and hep B as areas of liver and with the expertise of Gilead, are areas we need to continue to explore, both internally and through partnerships as a part of a broader portfolio of approaches across different therapeutic areas.

    同樣,B肝也是如此,我的意思是,很顯然,我們現在有治療B型肝炎的方法,我們將繼續專注於此。但是,有機會繼續推進乙肝科學的發展,尤其是在尋找治癒方法方面,這讓我印象深刻,我看到了吉利德的科學家們正在探索的各種不同的科學方法。所以,Geoff,總而言之,我認為 NASH 和乙肝作為肝臟疾病領域,憑藉吉利德的專業知識,是我們需要繼續探索的領域,無論是在內部還是透過合作,作為跨不同治療領域的更廣泛方法組合的一部分。

  • Operator

    Operator

  • Our next question comes from the line of Brian Abrahams from RBC Capital Markets.

    下一個問題來自加拿大皇家銀行資本市場的布萊恩亞伯拉罕。

  • Brian Corey Abrahams - Senior Analyst

    Brian Corey Abrahams - Senior Analyst

  • On filgotinib, coming out of FINCH 1 and 3, where do you see the most differentiation for that product versus currently available in late-stage -- therapies in late-stage JAK1 inhibitors? And obviously, you're awaiting FDA feedback, but I'm curious, your willingness to file prior to completion of the MANTA study, I guess, how do you weigh speed to market for that product in a competitive space versus having to potentially optimize label right off the bat at the launch?

    關於 filgotinib,從 FINCH 1 和 3 研究中得出的結果來看,您認為該產品與目前已上市的後期 JAK1 抑制劑療法相比,最大的差異在哪裡?顯然,你們正在等待 FDA 的回饋,但我很好奇,你們為何願意在 MANTA 研究完成之前就提交申請?我想,在競爭激烈的市場中,你們是如何權衡產品上市速度與上市之初可能需要優化標籤之間的關係的?

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • Thanks, Brian. It's John here. Multi-part question. But look, we are -- let me just step back a bit and think and -- summarize what we think about the entire data set. We have the full data package now from our Phase III clinical trial. We have over 3,200 patients.

    謝謝你,布萊恩。我是約翰。多部分問題。但是,我們——讓我先退後一步,思考一下——總結一下我們對整個資料集的看法。我們現在已獲得三期臨床試驗的完整資料包。我們有超過3200名患者。

  • Look, we've shown in terms of characterization and although it's hard to do head-to-head comparisons across drugs, across studies, of course, what we have seen in our FINCH program consistent with our Phase II program, is deep efficacy responses in broad patient population.

    你看,我們在特徵描述方面已經證明,雖然很難在不同藥物和研究之間進行直接比較,但我們在 FINCH 項目中看到的與我們的 II 期項目一致的是,在廣泛的患者群體中產生了深遠的療效反應。

  • And if you're a practicing rheumatologist, that's what's most important to you. You're not getting to ACR20, you're getting strong ACR50 and strong ACR70 responses, remission responses, low disease activity. And all the FINCH trials show those deep responses when you characterize them by those characteristics.

    如果你是執業風濕病學家,那麼這才是你最關心的事情。你沒有達到 ACR20 標準,而是獲得了強烈的 ACR50 和 ACR70 反應、緩解反應以及低疾病活動度。所有 FINCH 試驗都顯示了這些深刻的反應,當你用這些特徵來描述它們時,就會發現這一點。

  • Look, each of the studies achieved all of their primary endpoints, and they showed improvement in functional status. And where we explored it, we showed that we could slow the rate of structural damage on the X-ray findings. So these are all important additional advantages of the drug of what we showed in our clinical program.

    你看,每項研究都達到了所有主要終點,並且都顯示功能狀態有所改善。我們研究發現,透過X射線檢查,我們可以減緩結構損傷的速度。所以這些都是我們在臨床項目中展示的該藥物的重要額外優勢。

  • So we'll go to -- as I said today on the earnings call, we have the full data package. We're impressed by the risk benefit. We think it's relevant to patients and rheumatologists. We'll be able to file in Europe in the second half of this year, and we'll go and have a discussion now with the FDA. We've requested that meeting, where we'll sit down and talk with them about what we have in terms of data from the MANTA study, what we have in terms of our Phase III registrational program and what we should do. And the time -- the time lines around that will play out during that meeting. But look, I think it's important to us, and Dan has brought this with his fresh eyes on the program recently, is that there is some degree of urgency for us to get this drug approved as quickly as we can and obviously, in collaboration with the regulators across the world.

    所以,正如我今天在財報電話會議上所說,我們掌握了完整的資料包。我們對這種風險收益比印象深刻。我們認為這與患者和風濕病學家都有關。我們將在今年下半年向歐洲提交申請,現在我們將與美國食品藥物管理局(FDA)進行磋商。我們已經要求召開那次會議,屆時我們將坐下來與他們討論我們在 MANTA 研究方面的數據、我們在 III 期註冊計劃方面的進展以及我們應該採取的措施。而時間——圍繞會議的時間線——將在那次會議期間展現出來。但是,我認為對我們來說很重要的一點是,丹最近以他全新的視角看待這個項目,那就是我們必須盡快獲得這種藥物的批准,而且顯然,這需要與世界各地的監管機構合作。

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Yes, I would just -- thank you, John. I would just add, Brian, that I think it's -- yes, I've been impressed by the profile of the product through all 3 FINCH studies and the consistency and the outcome and the results on both the efficacy and safety side. And knowing that rheumatoid arthritis patients are waiting for highly efficacious medicines that also have good safety and tolerability profiles, I think we're looking forward to the totality now of the discussion with the FDA. So we put the request for the meeting in. We expect to have that meeting by midyear, and we'll be looking forward to getting back to you on kind of the next steps. But we remain bullish on this and looking forward to bringing this as soon as possible to patients around the world and in the U.S.

    是的,我只想說——謝謝你,約翰。Brian,我還要補充一點,我認為——是的,FINCH 的 3 項研究都給我留下了深刻的印象,該產品的概況、一致性、效果以及在功效和安全性方面的表現都讓我非常滿意。鑑於類風濕性關節炎患者正在等待療效顯著且安全性和耐受性良好的藥物,我認為我們現在期待與 FDA 進行全面討論。於是我們提交了會議請求。我們預計將在年中召開會議,並期待就下一步措施與您聯繫。但我們對此仍然充滿信心,並期待盡快將這項技術帶給世界各地和美國的患者。

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • And of course, if I could add -- thank you, Dan. But the safety -- I forgot to mention, unfortunately, the safety profile. We actually had a press release about this because we thought it was important as well. And again, it's impossible to make cross-drug, cross-trial comparisons, but the safety profile we're seeing with this JAK1-specific inhibitor leads us to believe we have an additional benefit for patients as well. We're seeing low rates of infections, low rates of discontinuation, herpes zoster, thromboembolic events, cardiovascular events and so forth. So we also believe that, that's an important advantage for patients as well.

    當然,如果可以的話,我還要補充一句——謝謝你,丹。但是安全性——很遺憾,我忘了提及安全性方面的問題。我們其實也為此發布了一份新聞稿,因為我們也認為這件事很重要。再次強調,我們無法進行跨藥物、跨試驗的比較,但我們從這種 JAK1 特異性抑制劑中觀察到的安全特性讓我們相信,它還能為患者帶來額外的益處。我們看到感染率、停藥率、帶狀皰疹、血栓栓塞事件、心血管事件等發生率都很低。所以我們也認為,這對患者來說也是一個重要的優勢。

  • Operator

    Operator

  • Our next question comes from the line of Geoffrey Porges from SVB Leerink.

    我們的下一個問題來自 SVB Leerink 的 Geoffrey Porges。

  • Geoffrey Craig Porges - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

  • Robin, it might be premature to say congratulations. I know you're around through the end of the year, but at the very least, just wondering if you could help him with some Gmail settings. My storage is getting a little filled up.

    羅賓,現在說恭喜可能還太早。我知道你年底前都會在,但至少,我想問你能不能幫他設定 Gmail。我的儲物空間快滿了。

  • Robin L. Washington - CFO & Executive VP

    Robin L. Washington - CFO & Executive VP

  • I will work on that in 2020, Geoff.

    傑夫,我會在2020年著手處理這件事。

  • Geoffrey Craig Porges - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research, MD & Senior Biotechnology Analyst

  • I'm sure you could take care of that. But seriously, Dan, I wonder if you could comment, and perhaps Robin could weigh in on this as well, about capital allocation. You effectively returned 100% of your cash flow to shareholders through dividends and share buybacks this quarter. And obviously, that's not really sustainable. But Dan, could you talk about how you feel about dividends versus buybacks? And whether you will be willing to make any firm commitment to a certain proportion of cash flow being returned to investors versus other items?

    我相信你能處理好這件事。但說真的,丹,我想請你談談資本配置方面的問題,或許羅賓也可以發表一下看法。本季度,您透過分紅和股票回購,有效地將 100% 的現金流返還給了股東。顯然,這種做法是不可持續的。丹,你能談談你對分紅和股票回購的看法嗎?您是否願意就返還給投資者的現金流比例,而非用於其他用途,並做出明確的承諾?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Sure, Geoff. And I know that Robin will want to weigh on this as well, but let me just say a couple of things. As you noted in my priorities, my top 3 priorities, obviously, focusing on the pipeline and understanding it both from a internal Gilead perspective and also what's on the outside horizon is my top priority, as you can imagine. And therefore, I'm really pleased to get my deep dives into the R&D organization, but equally, I should have mentioned this, I spent a good amount of time with our corporate development organization, that I think is working really hand in glove with our research colleagues to identify and scan the external environments. And you can see the level of activity we've had now over the past year or so, 1.5 years, lots of partnerships and things that are going to supplement that portfolio.

    當然可以,傑夫。我知道羅賓也想就此事發表意見,但我想先說幾點。正如你在我的優先事項中指出的那樣,我的前三項優先事項顯然是專注於產品線,並從吉利德內部的角度以及外部前景的角度來了解它,這顯然是我的首要任務。因此,我很高興能夠深入了解研發部門,但同樣,我也應該提到,我花了很多時間與我們的企業發展部門一起工作,我認為該部門與我們的研究同事密切合作,以識別和掃描外部環境。你可以看到,在過去一年半的時間裡,我們開展了許多合作,建立了許多合作夥伴關係,這些都將補充我們的投資組合。

  • So back to the capital allocation. I consider it really to be in the following order in terms of priority. And the first one is where we can find opportunities to supplement our portfolio through M&A or partnerships, that's priority number one, because we think that's in the best interest of the long-term journey of shareholders in the company.

    所以,讓我們回到資本配置的問題。我認為它們的優先順序應該是這樣的:第一個面向是尋找透過併購或合作來補充我們投資組合的機會,這是首要任務,因為我們認為這符合公司股東的長期利益。

  • Secondly, then I would say, obviously, we want to keep an attractive dividend policy. And I think that's been shown by the past behavior that I've seen coming into Gilead. And then thirdly, smartly looking at share repurchases when those make sense. So I'm very clear that those are the orders of priority to create value for shareholders in my experience and also been reinforced on my journey into Gilead. Robin, what do you think about storage capacity? No, he's talking about capital allocation.

    其次,很顯然,我們希望維持有吸引力的股息政策。我認為,我過去在進入基列國後所看到的行為已經證明了這一點。第三,要明智地考慮在適當的時機進行股票回購。因此,我非常清楚,根據我的經驗,這些是為股東創造價值的優先順序,而我在吉利德的經驗也強化了這一點。羅賓,你覺得儲存容量怎麼樣?不,他指的是資本配置。

  • Robin L. Washington - CFO & Executive VP

    Robin L. Washington - CFO & Executive VP

  • Yes, I mean I think as we continue to discuss externally, pre-Dan and ongoing, I think we're very aligned in terms of our priorities. Dan, I think you articulated that very well. We've been fairly consistent with continuing to focus on our dividend as being the primary shareholder return vehicle, and we expect that to continue. And we believe ultimately, that's very important to our shareholders. And share repurchases, we've leveraged, as you said, where appropriate. So I think we continue to be aligned, Geoff. You're right, we haven't necessarily published a specific level of cash flow returns, but I think if you look over the multiple-year period, we've returned about 50% of free cash flows to shareholders in the forms of dividends as well as share repurchase, and that's varied year by year as we made the necessary investments to grow the company. We believe we have the financial flexibility to retain the dividend and make the investments that Dan and the rest of the leadership team sees as appropriate to grow and strengthen the pipeline, as Dan outlined.

    是的,我的意思是,我認為隨著我們繼續與外界討論,無論是在丹之前還是之後,我認為我們在優先事項方面都非常一致。丹,我覺得你表達得非常清楚。我們一直以來都比較堅持將分紅作為股東回報的主要途徑,我們預期這種情況會持續下去。我們相信,這最終對我們的股東來說非常重要。正如你所說,我們在適當的時候也利用了股票回購。所以我覺得我們仍然保持一致,傑夫。你說得對,我們並沒有公佈具體的現金流回報水平,但我認為,如果你縱觀多年,我們已經將大約 50% 的自由現金流以股息和股票回購的形式返還給了股東,而且由於我們進行了必要的投資以發展公司,這個比例每年都會有所不同。我們相信我們有足夠的財務靈活性來維持分紅,並進行丹和其他領導團隊認為合適的投資,以發展和加強產品線,正如丹所概述的那樣。

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • And Geoff, I would just say in my listening tour, I've been listening to many of you on the phone here and beyond, and I think broadly speaking, there was quite a bit of alignment between that capital allocation policy. So hopefully, we're also meeting your needs, as well as the company needs, which should go hand in hand.

    傑夫,我想說的是,在我的傾聽之旅中,我聽取了你們許多人透過電話以及其他方式提出的意見,我認為總的來說,這種資本配置政策之間存在相當大的一致性。所以,我們希望既能滿足您的需求,也能滿足公司的需求,這兩者應該是相輔相成的。

  • Operator

    Operator

  • Our next question comes from the line of Michael Yee from Jefferies.

    我們的下一個問題來自傑富瑞集團的邁克爾葉。

  • Michael Jonathan Yee - Equity Analyst

    Michael Jonathan Yee - Equity Analyst

  • I wanted to ask a question to Dan. You listed pipeline enhancement as a top priority. Maybe just speak a little bit more to that in terms of how you're thinking about prioritizing parts of the pipeline. I mean at Roche, which obviously you had a long time at, you didn't really do any deals above $8 billion, but maybe just talk about how you think about what may be different here at Gilead and maybe the appetite for M&A? How you're looking at the environment out there here at Gilead?

    我想問丹一個問題。您將管道優化列為首要任務。或許可以再詳細談談您是如何考慮對流程中的各個環節進行優先排序的。我的意思是,你在羅氏工作了很長時間,顯然你沒有真正做過任何超過 80 億美元的交易,但也許可以談談你認為吉利德這裡可能有哪些不同之處,以及他們對併購的興趣?您如何看待吉利德這裡的工作環境?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Yes, thanks, Michael, for the question. I mean maybe just to expand a little bit from the previous question, I would say that as usual, I think priority number one is to -- is that our M&A activity is led by science at the end of the day. And therefore, one focuses on some of the expertise that we have within the company and that would obviously be in the areas of now oncology with the acquisition of Kite and the growing portfolio we have here, liver diseases, inflammation and HIV.

    是的,謝謝你的提問,麥可。我的意思是,或許可以稍微擴展一下上一個問題,我想說,和往常一樣,我認為首要任務是——歸根結底,我們的併購活動是由科學驅動的。因此,我們專注於公司內部的一些專業知識,這顯然包括收購 Kite 後在腫瘤學領域以及我們不斷增長的產品組合,以及肝病、發炎和 HIV 領域。

  • Not to suggest that we wouldn't be opportunistic on something that has an interesting scientific profile and a high unmet medical need, where we think we could bring a transformational difference. So I want you to know we're scanning the entirety of the environment and we're science-led. But obviously, I think overall, you're generally better positioned to identify the opportunities where you have expertise in-house. And I think that was true in my previous company, and it's also seems to be true from what I've seen here at Gilead as well.

    這並不是說我們不會抓住機會,去研究那些有趣科學背景和高度未滿足的醫療需求,我們認為我們可以帶來改變改變的領域。所以我想讓你們知道,我們正在對整個環境進行掃描,而且我們是以科學為導向的。但顯然,我認為整體而言,你通常更有能力發現那些你擁有內部專業知識的機會。我認為在我之前的公司是這樣,而且從我在吉利德公司看到的情況來看,似乎也是如此。

  • And I think, again, I think as we all know, I think -- and it's been true here when I've looked at the Gilead activity over the past couple of years, the vast majority of the opportunities are kind of an early-stage or a mid-stage. And I think the opportunity to create value exists quite a bit in those areas, particularly when you can find something earlier or more exciting because of the relevance of your science. But having said that, we also acknowledge that we need to look at our late-stage portfolio and pipeline and strengthen that. And I think there's 2 different ways to do that. One is to look at accelerating internal programs, which I know John and the team are constantly looking at, and I've been interested in speaking more about that. So there may be opportunities to take some risk and to accelerate things and to expedite things through applying resources. And the other thing is, of course, to bring interesting late-stage assets in.

    而且我認為,正如我們都知道的那樣,我認為——而且在我過去幾年觀察吉利德的活動時也證實了這一點——絕大多數機會都處於早期或中期階段。我認為在這些領域存在著創造價值的機會,特別是當你的科學與現實相關,能夠更早或更令人興奮地發現某些東西時。但話雖如此,我們也承認我們需要審視我們的後製產品組合和研發管線,並加強這方面。我認為有兩種不同的方法可以做到這一點。一是著眼於加速內部項目,我知道約翰和他的團隊一直在關注這個問題,我也一直很想多談談這方面。因此,或許有機會承擔一些風險,透過運用資源來加速和加速進程。當然,還有一點就是引進有潛力的後期資產。

  • So overall, I think the vast majority of the work that Gilead has done and arguably, they've been quite successful with their late-stage acquisition approach over the course of their 30-year history. I mean we'll be looking for opportunities like that as well, of course, to fulfill the pipeline with a keen sense on the science. And I think bolt-on type acquisitions are, continue to be, in my opinion, the highest likelihood and the way that we'll be proceeding.

    總的來說,我認為吉利德公司在過去 30 年的發展歷程中,透過後期收購策略所取得的絕大部分成功,可以說非常成功。當然,我們也會尋找這樣的機會,以敏銳的科學意識來完善產品線。而我認為,在我看來,附加式收購仍然是最有可能的,也是我們將繼續採取的方式。

  • John, I don't know if you want to add anything from your -- your thoughts or your...?

    約翰,我不知道你是否想補充一些你的想法或其他內容?

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • I completely agree, Dan. I think we've always had the philosophy and the success with being led by the science. We feel most comfortable in making those decisions when we have the expertise internally, as you articulated. And we are opportunistic and prepared to take risks when we feel the science and the opportunity and the need exists.

    我完全同意,丹。我認為我們一直以來都秉持著以科學為導向的理念,並且取得了成功。正如您所闡述的,當我們擁有內部專業知識時,我們才能最輕鬆地做出這些決定。我們善於把握機會,當我們認為科學、機會和需求都存在時,我們願意承擔風險。

  • Operator

    Operator

  • Our next question comes from the line of Carter Gould from UBS.

    我們的下一個問題來自瑞銀集團的卡特古爾德。

  • Carter Lewis Gould - Large Cap Biotech Analyst

    Carter Lewis Gould - Large Cap Biotech Analyst

  • Maybe to follow up, Dan, on your comments around the Kite organizational structure and separating that as its own business unit. Maybe talk about what drove the decision and what you hope that will achieve? And maybe any sort of consequences for future BD focused on cell therapy?

    丹,或許可以就你之前關於 Kite 組織結構以及將其分離成一個獨立業務部門的評論做個補充說明。或許可以談談促使你做出這個決定的原因,以及你希望這個決定能達到什麼目的?這會對未來以細胞療法為重點的生物醫學發展產生什麼影響?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Absolutely, Carter. Yes, I think the bottom line is that I've been very encouraged by what I've seen at Kite since I've come in and how the Gilead colleagues have approached their entry into oncology in a very significant way. I think the concept of moving towards a new platform, a new technology in this space as an entry point into oncology, having come from a background of deep oncology experience and understanding the depth of the competitive environment, is an intriguing way to go. So to really go for a future-oriented technology, I think makes a lot of sense.

    當然,卡特。是的,我認為最重要的是,自從我加入Kite以來,我在這裡所看到的以及吉利德的同事們以非常重要的方式進入腫瘤學領域,都讓我深受鼓舞。我認為,憑藉著深厚的腫瘤學經驗和對競爭環境的深刻理解,以新平台、新技術作為進入腫瘤學領域的切入點,是一個引人入勝的策略。所以,真正採用面向未來的技術,我認為這很有意義。

  • And then to supplement that with interesting partnerships like the one that John and his team have done in bispecific antibodies, for instance, with Agenus and/or some of the interesting small molecule work that's going on here within the walls of Gilead. So first and foremost, I think one needs to consider the early, but interesting oncology work that's going on here at Gilead. And then with that context, we said -- I said as I've looked at it in discussions with the leadership team, that Kite itself in cell therapy oncology is in a ultra-competitive area. I think we have a leadership position, but I think we need to maintain that leadership position. And for the reasons of focus, we decided to create Kite as an independent business unit that will wake up and go to sleep every day thinking about how to be leaders in oncology cell therapy.

    此外,還可以透過一些有趣的合作來補充,例如約翰和他的團隊在雙特異性抗體領域與 Agenus 的合作,以及吉利德內部正在進行的一些有趣的小分子研究。所以首先,我認為我們需要考慮吉利德公司正在進行的早期但有趣的腫瘤學研究。然後,基於這種背景,我們說——正如我在與領導團隊的討論中所說,Kite 本身在細胞治療腫瘤學領域處於競爭極其激烈的領域。我認為我們擁有領先地位,但我們需要保持這種領先地位。出於專注的考慮,我們決定將 Kite 創建為一個獨立的業務部門,讓它每天醒來和入睡前都思考如何成為腫瘤細胞治療領域的領導者。

  • Now that's not to suggest that they won't work with the rest of the organization to complement, as we know specifically in oncology, the combination approach and the multi-science approach is absolutely the way to go. But we need to make sure we secure that leadership in cell therapy while we complement it with combination approaches in immuno-oncology or targeted therapies or other mechanisms. So that's the context. Let's make sure we win in cell therapy and leverage the remaining parts of the Gilead focus on oncology to win in the broader oncology market as well.

    但這並不意味著他們不會與組織內的其他部門合作進行互補,正如我們所知,尤其是在腫瘤學領域,聯合療法和多學科療法絕對是正確的方向。但我們需要確保在細胞療法領域保持領先地位,同時輔以免疫腫瘤學、標靶療法或其他機制的聯合療法。以上就是背景資訊。讓我們確保在細胞療法領域取得成功,並利用吉利德在腫瘤學領域的其他優勢,在更廣泛的腫瘤學市場中也取得勝利。

  • So -- and it's with that lens that I took the decision to create a separate business unit to focus that and now in the process of recruiting a CEO that will report in to me, that will work very closely with the leadership team for success in oncology.

    所以——正是基於這種視角,我決定創建一個獨立的業務部門來專注於此,現在正在招聘一位首席執行官,他將向我匯報工作,並與領導團隊密切合作,以在腫瘤學領域取得成功。

  • Now on the BD side, there's been a very active, as you know, since the Kite acquisition, a very active M&A and partnership work within cell therapy, which I think is fundamental and essential, because the science is occurring, of course, within Kite and cell therapy, but all around us as well.

    現在,在業務拓展方面,正如您所知,自從收購 Kite 以來,細胞療法領域的併購和合作工作一直非常活躍,我認為這是根本性的、至關重要的,因為這項科學研究當然是在 Kite 和細胞療法領域進行的,但也是在我們周圍進行的。

  • So I have been impressed with the landscape analysis that the BD team has done here with the research and development team at Kite and at Gilead. And I think we're really well-positioned to continue to scan that environment and to complement it with the appropriate pieces of the puzzle that we need to continue to write the next chapter in cell therapy history. And as John articulated, it's advances and hematologic malignancies, it's moving to solid tumors and it's also getting ready for the future of science, the allogeneic form as well, which has risks, but I think lots of opportunities as well. So very comprehensive approach on the BD side and that will continue.

    我對 BD 團隊與 Kite 和 Gilead 的研發團隊共同進行的產業格局分析印象深刻。我認為我們已經做好了充分的準備,可以繼續關注這個環境,並補充我們需要的適當要素,從而繼續書寫細胞治療歷史的下一個篇章。正如約翰所闡述的那樣,它取得了進展,治療血液惡性腫瘤,並正在向實體瘤發展,同時也在為科學的未來做好準備,包括同種異體移植,這雖然有風險,但我認為也有很多機會。因此,在業務拓展方面採取了非常全面的方法,而且這種方法還會繼續下去。

  • John, any perspective?

    約翰,你有什麼看法?

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • Completely agree, Dan.

    完全同意,丹。

  • Operator

    Operator

  • Our next question comes from the line of Ying Huang from Bank of America Merrill Lynch.

    我們的下一個問題來自美國銀行美林證券的黃穎。

  • Ying Huang - Director in Equity Research

    Ying Huang - Director in Equity Research

  • Maybe for Daniel, is there anything you actually want to change in the Gilead organization after 2 months in the job? And then maybe another one for John McHutchison quickly, you decided to have a collaboration with Novo Nordisk in NASH. How does it compare to the other mechanisms of actions in the market today or under development today, if you look at semaglutide data in NASH?

    或許對丹尼爾來說,在吉利德工作兩個月後,他真的想對公司做出哪些改變?然後,也許約翰·麥克哈奇森很快又決定與諾和諾德公司在 NASH 領域展開合作。如果看一下司美格魯肽在 NASH 的數據,它與目前市場上或正在研發的其他作用機制相比如何?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Thanks, Ying. And look, let me first say that I have been incredibly welcomed and very impressed with coming into Gilead. So I think I probably know more of what I don't want to change than what I do want to change after 2 months in the role. And that is the focus on science. I've been really impressed by the science and the motivation and intelligence of the colleagues at Gilead. I think both the level of expertise that is here in many different areas as well as the intrinsic motivation of our employees is something that I've been deeply, deeply impressed by.

    謝謝你,穎。首先,我要說的是,我受到了基列國的熱烈歡迎,我對這裡的一切都印象深刻。所以我覺得,在這個職位工作兩個月後,我可能更清楚自己不想改變什麼,而不是想改變什麼。這就是對科學的關注。吉利德公司同事們的科學精神、積極性和智慧給我留下了深刻的印象。我對公司在各領域的專業水準以及員工的內在動力都深感敬佩。

  • So in terms of what to change, as I said before, I'm still in the process of evaluating the organization, looking at pipeline, looking at commercial execution, looking at the organizational structure and people. And I think you would agree with me that 2 months is a relatively short period of time to evaluate that, which is why I said there are certain things that I'm acting quickly on and won't hesitate to, like the Kite decision, and there are other things I think I need to learn a little bit more and understand. But it will be an evolution not a revolution, and it will be based upon good observations, good discussions with the leadership team in terms of how we progress here. So stay tuned on that. And as I think we as a leadership team and a leadership community here at Gilead with the board, and we continue to have our outside ears open to investors and to thought leaders and to what our patient needs are, we'll continue the evolution of the company, and I'll be articulating better what my priorities are as I go into the later part of this year, and will certainly inform you as I go. So thank you for the question. And John, would you...

    所以,就需要改變的地方而言,如我之前所說,我仍在評估組織,檢視產品線、商業執行、組織結構和人員。我想你會同意我的看法,兩個月的時間對於評估這件事來說相對較短,所以我說有些事情我會迅速採取行動,毫不猶豫,比如關於 Kite 的決定,而其他一些事情我認為我需要更多地了解和理解。但這將是一次漸進式的演變,而不是一場革命,它將基於良好的觀察,以及與領導團隊就我們如何在這裡取得進展進行的良好討論。敬請關注。我認為,作為吉利德的領導團隊和領導群體,以及董事會,我們將繼續傾聽投資者、思想領袖以及患者的需求,並推動公司不斷發展。在今年下半年,我會更清楚地闡述我的工作重點,並隨時向大家報告。謝謝你的提問。約翰,你願意…

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • Yes, as we know, Novo Nordisk, Ying, that's a compelling mechanism of action. Novo Nordisk is clearly a leader in the pharmaceutical development of products for patients with diabetes and metabolic syndrome. Mechanism of action is not necessarily directly related to NASH, but it has many of the effects you would want to see in patients with NASH. And additional and importantly, as well as all those other metabolic benefits in terms of glucose control, insulin secretion and so forth, is a weight loss component to this drug and a significant weight loss component. And that weight loss component, we think, is very compelling for us to explore with our other mechanisms of action that are really focusing on different and separate drivers of NASH hypogenesis. So we believe it's a very exciting and a very important collaboration. Novo Nordisk brings a lot of people and a lot of depth of knowledge about metabolic syndrome to the table, whilst we bring a lot of expertise in liver disease. So it's a wonderful collaboration that we're just starting and looking forward to. So we will combine semaglutide with our FXR agonist and our ACC drug as well and that will be the initial clinical collaboration.

    是的,正如我們所知,諾和諾德,Ying,那是一種引人注目的作用機制。諾和諾德顯然是糖尿病和代謝症候群患者藥物研發的領導者。其作用機制不一定與 NASH 直接相關,但它具有許多您希望在 NASH 患者身上看到的效果。此外,更重要的是,除了在血糖控制、胰島素分泌等方面的所有其他代謝益處之外,這種藥物還具有減肥作用,而且是顯著的減肥作用。我們認為,這種減肥成分非常值得我們去探索,它與我們其他的作用機制相結合,真正專注於 NASH 低發生率的不同和獨立的驅動因素。所以我們認為這是一次非常令人興奮且非常重要的合作。諾和諾德公司擁有大量人才和豐富的代謝症候群相關知識,而我們則擁有豐富的肝病專業知識。所以這是一項我們剛開始並充滿期待的美好合作。因此,我們將把索瑪魯肽與我們的 FXR 激動劑和我們的 ACC 藥物結合起來,這將是最初的臨床合作。

  • Operator

    Operator

  • Our next question comes from the line of Umer Raffat from Evercore.

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

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • And welcome, again, Dan, to your first Gilead call. I wanted to keep it fairly high level today. I'll maybe just ask Dan, do you see Gilead as growing top line into 2020? And also, what are the biggest risks and the biggest opportunities that you see at Gilead currently?

    再次歡迎丹參加你的第一次吉利德電話會議。我今天想保持較高的水平。我或許可以問問丹,你認為吉利德的營收在 2020 年會持續成長嗎?另外,您認為吉利德目前面臨的最大風險和最大機會是什麼?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Thanks a lot, Umer, for the warm welcome. Again, I really appreciate and look forward to working with all of you and obviously articulating my views and visions for the company as I go.

    非常感謝烏默的熱情款待。再次感謝各位,我非常期待與大家共事,當然,我也會隨時向大家闡述我對公司的看法和願景。

  • It is definitely premature to talk about sales in 2020 at this stage. In fact, in the first 2 months, I've really been focusing, as you know, on pipeline and understanding our current commercial delivery. We will, over the coming months, of course, in the natural process of things, start to digest the progress that we have for this year, the opportunities we have for next year and put those into some ideas of a plan. So I think it's a bit too premature for that. What I can assure you is that we'll give you a sense for that much later in the year. At this stage, I mean maybe just to add a little additional color to that from the way that I see the business today. I see the strength in HIV clearly as a real foundation, of course, of Gilead and a strong and growing business. Laura mentioned the progress in Biktarvy. Both Laura and John talked about the really good data on the Descovy and the opportunity there with the DISCOVER trial. So I do see good strength in the HIV business. I see the opportunity that HCV is much more predictable at this stage and a much smaller part of the overall revenue turnover at Gilead.

    現在談論2020年的銷售情況肯定為時過早。事實上,正如您所知,在前兩個月裡,我一直專注於通路建立和了解我們目前的商業交付情況。當然,在接下來的幾個月裡,我們將按照自然規律,開始消化今年的進展、明年面臨的機遇,並將這些想法融入計畫中。所以我覺得現在說這些還太早。我可以向你保證的是,今年稍後我們會給你更詳細的說明。現階段,我的意思是,或許只是想從我目前對這個產業的看法出發,為它增添一些色彩。我清楚地看到,愛滋病防治領域的優勢是吉利德公司的真正基礎,也是其業務蓬勃發展的真正基石。勞拉提到了比克塔維的進展。Laura 和 John 都談到了 Descovy 的非常好的數據,以及 DISCOVER 試驗帶來的機會。所以我確實看到了愛滋病防治產業良好的發展動能。我認為,現階段丙型肝炎的可預測性大大提高,而且在吉利德公司整體收入中所佔比例也小得多,這為丙型肝炎帶來了機會。

  • And then I see the future opportunities, such as filgotinib and others that we'll be discussing with all of you as upside to that relatively stable base. And the question that I need to digest with the team is to understand how and when those opportunities will be hitting and I just want to give you a little bit more color as to how I see the business and I think the opportunities.

    然後,我看到了未來的機遇,例如filgotinib和其他一些我們將要和大家討論的藥物,它們在這個相對穩定的基礎上具有上升空間。我需要和團隊一起探討的問題是,如何以及何時才能抓住這些機會。我還想更詳細地向大家介紹我對這個行業以及我認為這些機會的看法。

  • So what are the risks and opportunities? Again, I need a bit more time than 2 months to come back to you with a comprehensive list. I think I've given you a bit of an idea on the call here today. I do think that there are tremendous opportunities in the early and mid-stage pipeline, and I think we also have a real opportunity with filgotinib. I mean this is a profile of a product in a space that needs -- that patients and physicians need more treatment options, and they're looking for treatment options that are highly efficacious, that are safe and that are convenient. And so I think I've been working with the organization, with the leadership team, to really think about how can we accelerate some of the plans around filgotinib, how do we get ready for entering this very competitive space. And obviously, with all of these launches comes both risks and opportunities, but I do think that we have a very good profile product on which to build one of our next legs of success at Gilead, the whole leg of inflammation, accordingly.

    那麼,風險和機會是什麼?再次聲明,我需要比兩個月更多的時間才能給你一份完整的清單。我想我今天在電話會議上已經向你大致說明了情況。我認為早期和中期研發管線蘊藏著巨大的機遇,我認為filgotinib也為我們帶來了真正的機會。我的意思是,這是一個產品概況,它滿足了患者和醫生對更多治療選擇的需求,他們正在尋找高效、安全、便捷的治療方案。因此,我認為我一直在與公司和領導團隊合作,認真思考如何加快與 filgotinib 相關的一些計劃,如何為進入這個競爭非常激烈的領域做好準備。顯然,所有這些產品發布都伴隨著風險和機遇,但我認為我們擁有一個非常好的產品,可以以此為基礎,在吉利德的下一個成功階段——發炎治療領域——取得成功。

  • Likewise, I think we should mention in that same statement around the overall business picture, the ongoing success of Yescarta, the ability to think about moving into other diseases and hematologic malignancies, lots of readouts on Yescarta, just was reviewing with John just before the call, there's a lot of interesting readouts that will come in the coming year, 2 years, 3 years, that I think will help us understand the utility of cell therapy, both with and without combination approaches in oncology. So I'll give you an even more complete view of the business, Umer, later this year from my perspective, but those are some of my early insights into what I've seen so far.

    同樣,我認為我們應該在關於整體業務情況的聲明中提及 Yescarta 的持續成功,以及考慮進軍其他疾病和血液惡性腫瘤的能力,Yescarta 有很多數據公佈,就在電話會議之前我和 John 一起回顧了一下,未來一到兩年、三年內將有很多有趣的數據公佈,我認為這將有助於我們了解細胞價值在腫瘤學中是否採用聯合療法。所以,烏默,今年晚些時候我會從我的角度給你更全面地介紹一下這家公司,但這些是我目前為止的一些初步看法。

  • Operator

    Operator

  • Our next question comes from the line of Phil Nadeau from Cowen and Company.

    我們的下一個問題來自 Cowen and Company 的 Phil Nadeau。

  • Philip M. Nadeau - MD and Senior Research Analyst

    Philip M. Nadeau - MD and Senior Research Analyst

  • Robin, let me add my congratulations on the announcement of your retirement. Dan, a question for you, actually, on HIV, just to focus there. Gilead's clearly been a leader in HIV treatment for almost 2 decades. But arguably, you've fallen behind in the development of nucleoside-sparing regimens and long-acting regimens. So you brought fresh eyes to looking at your HIV portfolio. How do you see the treatment of HIV evolving over the next 5 to 10 years? And do you feel like Gilead's HIV pipeline has all the programs that it needs to stay competitive over that period?

    羅賓,請容許我向你宣布退休表示祝賀。丹,其實我有個關於愛滋病的問題想問你,就集中在這個方面吧。近二十年來,吉利德顯然一直是愛滋病治療領域的領導者。但可以說,你們在核苷類藥物替代療法和長效療法的研發方面已經落後了。所以你為審視你的愛滋防治計畫帶來了全新的視野。您認為未來 5 到 10 年愛滋病治療將如何發展?您認為吉利德的 HIV 產品線是否具備在該時期保持競爭力所需的所有項目?

  • Daniel O'Day - Chairman & CEO

    Daniel O'Day - Chairman & CEO

  • Thanks, Phil, and I welcome John and Laura to feed in on this as well, but I'll give you my top line take first. And that is that there's no doubt that Gilead is the leader in HIV, has been for a long time and to your point, so we need to make sure that we continue to have the most significant next advance for patients and that's certainly been the case for TAF. From TAF, the regimens and to the Descovy regimens and now, of course, with the PrEP data and certainly, there's lots more that we can do in improving the patient experience in HIV, including long-acting, as you mentioned, and other approaches. So I think there's a very comprehensive life cycle plan around this, and I think the thinking that's gone into this in terms of making sure that the next-generation programs like a long-acting, are something that are going to be well-received by the patients, that are convenient, easy-to-take and really allow for, if you like, the next best advance from a daily oral medicine, which is, let's face it, highly convenient to begin with. So I think they really scrutinize the target profile well and I think the science that's going on here is well-positioned to continue to take the next meaningful advances for patients into the future. But I would ask, John, if you want to feed in on this? Great.

    謝謝菲爾,我也歡迎約翰和勞拉參與討論,但我先說說我的主要看法。毫無疑問,吉利德是 HIV 領域的領導者,而且已經保持了很長時間。正如你所說,我們需要確保我們繼續為患者帶來最重大的下一步進展,而 TAF 無疑就是這種情況。從 TAF 療法到 Descovy 療法,當然還有現在的 PrEP 數據,我們肯定還有很多工作可以做,以改善 HIV 患者的體驗,包括您提到的長效療法和其他方法。所以我認為這方面有一個非常全面的生命週期計劃,而且我認為其中的思考是為了確保下一代項目,比如長效藥物,能夠受到患者的歡迎,方便服用,並且真正能夠實現每日口服藥物的下一個最佳進步,而每日口服藥物,說實話,本身就已經非常方便了。所以我認為他們確實對目標群體進行了非常仔細的審查,而且我認為這裡正在進行的科學研究已經做好了充分的準備,可以繼續為患者帶來下一個有意義的進展。但我想問約翰,你是否願意參與討論?偉大的。

  • John G. McHutchison - Chief Scientific Officer and Head of Research & Development

    John G. McHutchison - Chief Scientific Officer and Head of Research & Development

  • Sure, thanks, Phil. Phil, we have led the field of HIV therapeutic development for over a decade. And one of the critical components of that approach and our success has been no resistance. And that has been achieved with effective 3 drug regimens. So for example, with all the Biktarvy studies, as you know, we have no resistance through week 96, which is a critical advantage for anybody. You can't afford to increase the fragility of a regimen by decreasing or diminishing or cutting out one of the components. And theoretically, or not theoretically, increasing the risk of resistance. So that's very important. Now 2 drug regimens where adherence is potentially not so important, such as an effective long-acting regimen, is actually one of our critical programs internally. And we believe that our ultimate goal with a long-acting regimen should be a subcutaneous at-home, small volume, non-painful injection that's probably got 2 components to it, but it won't have that adherence issue to it, and we'd like to be giving it every 3 months. That would be a great advance for patients as well.

    當然,謝謝你,菲爾。菲爾,十多年來,我們一直處於愛滋病治療藥物研發領域的領先地位。而這種方法和我們成功的關鍵因素之一就是沒有遇到阻力。而這已經透過有效的3種藥物治療方案實現了。例如,正如您所知,根據所有 Biktarvy 研究,我們在 96 週之前沒有任何阻力,這對任何人來說都是至關重要的優勢。你不能因為減少、削弱或取消某個組成部分而增加治療方案的脆弱性。理論上(或理論上),這會增加產生抗藥性的風險。所以這一點非常重要。現在,對於某些藥物治療方案(例如有效的長效治療方案),依從性可能不太重要,而這實際上是我們內部的關鍵項目之一。我們相信,長效療法的最終目標應該是皮下注射,在家即可使用,小劑量,無痛,可能包含兩種成分,但不會存在依從性問題,我們希望每 3 個月注射一次。這對患者來說也將是一個巨大的進步。

  • And in terms of our other activities in HIV, we have many cure programs, as you know. We also have programs for those most in need in terms of the highly-resistant groups of patients. And then, of course, we have all of our PrEP programs, as we discussed on the call today.

    至於我們在愛滋病防治方面的其他活動,我們有很多治癒項目,您也知道。我們也為那些最需要幫助的、對治療反應極強的患者群體制定了相應的計劃。當然,我們也有所有的 PrEP 項目,正如我們今天在電話會議上討論的那樣。

  • So we are very much laser-focused on maintaining our leadership position scientifically and for patients with HIV and preventing HIV, by all of these initiatives.

    因此,我們非常專注於透過所有這些舉措,在科學領域以及為愛滋病患者和預防愛滋病方面保持領先地位。

  • So I think the issue of 2 versus 3 drug regimens has to be put in context of the decades of history of this disease and where the long-acting ultimate goal should be.

    所以我認為,關於 2 種藥物治療方案與 3 種藥物治療方案的問題,必須放在這種疾病幾十年的歷史背景下看待,並考慮長效治療的最終目標應該是什麼。

  • Operator

    Operator

  • Our next question comes from the line of Cory Kasimov from JPMorgan.

    我們的下一個問題來自摩根大通的科里·卡西莫夫。

  • Cory William Kasimov - Senior Biotechnology Analyst

    Cory William Kasimov - Senior Biotechnology Analyst

  • I also have one on HIV, but more from a near-term commercial standpoint. So basically, curious how you're thinking about potential pricing pressures within the category over the near to medium term from both potential U.S. health care reform as well as competitors entering the space at substantial discounts to Gilead's regimens?

    我還有一份關於愛滋病毒的報告,但更多是從近期的商業角度出發。所以,我主要是想了解您如何看待近期到中期內該品類可能面臨的價格壓力,這些壓力既可能來自美國潛在的醫療改革,也可能來自競爭對手以遠低於吉利德療法的價格進入該領域?

  • Laura Hamill - EVP of Worldwide Commercial Operations

    Laura Hamill - EVP of Worldwide Commercial Operations

  • Thanks for the question. This is Laura. So let me start off with the pricing pressures in the U.S. health care and I assume what you're talking about is maybe the protected class with Medicare populations. So let me just address that. We've been actively engaged in a discussion around the protected class list, the part D benefit for the senior population. And all along, I think what's most important for the senior population is to ensure that they have access to safe and effective medicines that are appropriate as per the guidelines. We really want to make sure that there is no prior authorization that impedes rapid treatment and renewal of the long-term treatment for patients. And I think that there's been a significant groundswell across the community of advocacy of people, physicians, that really believe that it's important for the Medicare population to have access to the HIV regimens that they need and to maintain the protected class. So that's specific to the Medicare population.

    謝謝你的提問。這是勞拉。那麼,讓我先談談美國醫療保健的價格壓力,我猜你指的是享受聯邦醫療保險的受保護群體。讓我來談談這個問題。我們一直積極參與圍繞受保護群體名單和老年人D部分福利的討論。一直以來,我認為對老年人群來說最重要的是確保他們能夠獲得符合指南規定的安全有效的藥物。我們真心希望確保沒有任何事先授權會阻礙患者快速接受治療和長期治療的續期。我認為,在民眾和醫生群體中,已經出現了一股強大的倡導浪潮,他們真心相信,讓享受醫療保險的人群能夠獲得他們所需的 HIV 治療方案,並維持其受保護的地位,是非常重要的。所以這是專門針對聯邦醫療保險族群的。

  • As it relates to the commercial population, I would say that we're very pleased with the amazing coverage that we've been able to achieve with Biktarvy. Over 90% of the plans have Biktarvy rapidly available. You can see that in the numbers and what we just said in terms of treatment-naïve and switch patients, how quickly patients are moving to Biktarvy and obviously, 80% of our overall prescriptions are coming from a Descovy-based backbone. So we don't feel significant pressure on the commercial side as it relates to coverage and access.

    就商業人群而言,我們對 Biktarvy 所取得的驚人覆蓋率感到非常滿意。超過 90% 的方案都能快速獲得 Biktarvy。從數據和我們剛才所說的關於初治患者和轉診患者的情況可以看出,患者轉用 Biktarvy 的速度非常快,而且顯然,我們 80% 的處方都是基於 Descovy 的。因此,我們在商業方面,尤其是在覆蓋範圍和接入方面,並沒有感受到太大的壓力。

  • As it relates to the overall growth that we see, as I mentioned, we had a 12% prescription growth year-over-year, and we've continued to maintain double-digit growth for the last couple of years. So I'm very, very pleased with that. And then finally, you asked about the competition and pricing pressure. So I think we've always tried to make sure we bring innovation into the market and I believe there are, for Gilead, it's been 11 products in 17 years, we've always been mindful of the pricing in the market to make sure that our innovation gets rapid access and people can access these new brands. And if we look at new entrants, I believe that their pricing is relative to the branded pricing of the components. So for example, Truvada is really the branded price of the 2 drugs. And I believe Biktarvy has been also priced very competitively within the Descovy-based backbone. So we feel very comfortable with our pricing.

    至於我們所看到的整體成長,正如我所提到的,我們的處方量年增了 12%,並且在過去幾年中一直保持著兩位數的成長。所以我對此非常非常滿意。最後,您問到了競爭和價格壓力。所以我認為我們一直努力確保將創新帶入市場,我相信吉利德在過去的17年裡推出了11款產品,我們一直關注市場定價,以確保我們的創新能夠快速普及,讓人們能夠獲得這些新品牌。如果觀察新進入者,我認為他們的定價與組件的品牌定價是相關的。例如,Truvada 實際上是這兩種藥物的品牌價格。而且我認為,在基於 Descovy 的基礎架構中,Biktarvy 的定價也非常有競爭力。因此,我們對自己的定價非常有信心。

  • Robin L. Washington - CFO & Executive VP

    Robin L. Washington - CFO & Executive VP

  • Yes, Cory, I'd just add also, remember that for Gilead, our franchise has really been driven by volume, right? Pricing has been frozen in the public market since I've been here. So we don't get real upside relative to pricing, particularly in the U.S. and as you know, ex U.S., we saw pricing decreases. So I'm totally in agreement with everything Laura provided in terms of our focus legislatively and competitively, but it's just -- underlying price has never been a key factor when you take a look at our HIV revenues.

    是的,科里,我還要補充一點,記住,對於基列公司來說,我們的特許經營權實際上是由銷售驅動的,對吧?自從我來到這裡以來,公開市場的價格一直保持不變。因此,相對於價格而言,我們並沒有獲得真正的上漲空間,尤其是在美國,正如你所知,在美國以外,我們看到了價格下降。所以我完全同意勞拉在立法和競爭方面提出的所有觀點,但是——當你查看我們的 HIV 收入時,基礎價格從來都不是一個關鍵因素。

  • Operator

    Operator

  • And our final question for today comes from the line of Ronny Gal from Bernstein.

    我們今天的最後一個問題來自伯恩斯坦的 Ronny Gal 的一句話。

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • Two of them if I can. One about HCV. I noticed the agreements you just had in the U.K. and the one you had in Louisiana. Can you just explain to us from a financial perspective how you're thinking about this? There's some implied discount in those contracts, but obviously, you're getting access to other patients you wouldn't otherwise. So can you just tell us how you're thinking about this as a strategy? And then coming back to this issue of HIV pricing. I hear you about not raising prices, but Robin, I think you mentioned that with this shift of patients to government programs, you're actually seeing a bit of a net decline and if we look at the revenue reported and divided by IMS scripts, we are seeing kind of like modest declines year-over-year in your price point. Should that be the baseline assumption going forward? Essentially, more people going on those programs, you guys not raising prices and as in effect, we should see a net price decrease a little bit per year, the way the market is looking right now?

    如果可以的話,我想選兩個。一篇關於丙型肝炎的文章。我注意到你剛剛在英國簽署的協議,以及你在路易斯安那州簽署的協議。您能否從財務角度解釋一下您是如何考慮這個問題的?這些合約隱含了一些折扣,但顯然,你可以接觸到一些你原本接觸不到的病人。那麼,您能告訴我們您是如何考慮將此作為一項策略的嗎?然後我們再回到愛滋病毒定價這個問題上來。我明白你不想漲價,但是羅賓,我想你提到過,隨著病人轉向政府項目,實際上淨收入有所下降,如果我們看一下報告的收入並除以 IMS 處方,我們會發現你的價格同比略有下降。這是否應該成為未來的基本假設?從本質上講,更多的人參加這些項目,你們又不提高價格,那麼實際上,按照目前的市場情況來看,我們應該會看到淨價格每年略有下降?

  • Robin L. Washington - CFO & Executive VP

    Robin L. Washington - CFO & Executive VP

  • Yes, Ronny, I'll take that -- the second part of your question. What I was referring to was just a shift relative to when public buyers purchase, right? And that's about payer mix, right? And typically in Q1, as you're in the ADAP cycle, we do see that downward shift driven by payer mix. The biggest overall driver of our sequential decline this past quarter, however, was not pricing at all, it was inventory, right? So I just want to clarify that, and happy to follow up after the call on that component. Laura, do you want to address the Louisiana and the Washington markets?

    是的,羅尼,我接受你的第二個問題。我指的是公眾買家購買時間的轉變,對吧?這就是支付方構成的問題,對吧?通常在第一季,由於處於 ADAP 週期,我們確實會看到由支付方組合驅動的這種下降趨勢。然而,導致我們上個季度環比下滑的最大因素根本不是價格,而是庫存,對吧?所以我想澄清一下,通話結束後我很樂意跟進這個部分。勞拉,你想談談路易斯安那州和華盛頓州的市場嗎?

  • Laura Hamill - EVP of Worldwide Commercial Operations

    Laura Hamill - EVP of Worldwide Commercial Operations

  • The U.K. Yes, yes. So -- and you -- I think you also mentioned U.K., if I heard you correctly. I thought it was U.K. and maybe Louisiana and Washington, was it all 3?

    英國。是的,是的。所以——還有你——如果我沒聽錯的話,你也提到了英國。我以為是英國,可能還有路易斯安那州和華盛頓州,難道是這三個州都包括在內嗎?

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • Yes.

    是的。

  • Laura Hamill - EVP of Worldwide Commercial Operations

    Laura Hamill - EVP of Worldwide Commercial Operations

  • Yes, okay. So let me talk about the U.K. and then I'll also talk about Louisiana. So really, our goal is to make sure that we work with governments the best we can, whether it's federal or state or country, to be able to provide the appropriate access for patients, and we believe HCV is a huge value to the health care system.

    好的。那麼,讓我先談談英國,然後再談談路易斯安那州。所以,我們的目標是盡我們所能與各級政府(無論是聯邦、州還是國家)合作,為患者提供適當的醫療服務,我們相信 HCV 對醫療保健系統具有巨大的價值。

  • So as it relates to Louisiana, this is particular to the needs of that government. And really, if you think about what we're trying to accomplish with Louisiana, they wanted to be able to treat a number of patients, but their annual budget is a certain amount every year. So if you think about 5 years, you have a certain amount every year, but the need actually is to treat more people earlier on. So really, the discussions that we're in with Louisiana is how do we basically smooth that out, so you don't have a big peak and then a trough? From a payment perspective, we can be flexible to try to work within the needs of the budgets and be able to give people access.

    因此,就路易斯安那州而言,這完全取決於該州政府的需求。實際上,如果你想想我們想在路易斯安那州實現的目標,他們希望能夠治療許多病人,但他們的年度預算每年都是固定的金額。所以,如果你考慮五年時間,每年你都有一定的治療量,但實際上需要的是更早治療更多的人。所以,我們和路易斯安那州討論的重點是如何平緩這種波動,避免出現大高峰和低谷?從支付角度來看,我們可以靈活一些,盡量滿足預算需求,並讓人們能夠獲得服務。

  • From the U.K. perspective, we're partnering with the U.K. as it relates to really an elimination project in the U.K., and there are actually a number of governments around the world that Gilead participates in arrangements such as this. And really, that's the focus. There's a price and then we're also working to make sure that we find patients and get them properly diagnosed and treated.

    從英國的角度來看,我們與英國合作,共同推動英國的根除計畫。事實上,吉利德也與世界各地許多國家的政府進行了類似的合作安排。而這才是重點。這其中既有成本,我們還要努力確保找到患者,並讓他們得到正確的診斷和治療。

  • And then finally, the last thing that I wanted to mention, which kind of plays into all of this, as you all know, is the launch of the AG by our subsidiary, Asegua. And I think that was another opportunity or strategy that was deployed by Gilead to make sure we were servicing the needs of the managed Medicaid market. So we have the flexibility between the Gilead portfolio of Sovaldi, Harvoni and Epclusa, that is made available in the commercial market. And of course, Asegua is also available in the commercial markets, but specifically to address the needs of managed -- the managed Medicaid market, we have offered up this opportunity to be able to address their particular needs. So hopefully that addresses your question.

    最後,我想提一下最後一點,這一點你們都知道,那就是我們的子公司 Asegua 推出了 AG。我認為這是吉利德公司為確保我們能夠滿足醫療補助管理市場的需求而採取的另一個機會或策略。因此,我們可以靈活選擇吉利德旗下的 Sovaldi、Harvoni 和 Epclusa 這三種產品組合,這些產品均可在商業市場上購買。當然,Asegua 也針對商業市場銷售,但特別是為了滿足管理式醫療補助市場的需求,我們提供了這個機會來滿足他們的特定需求。希望這能解答你的疑問。

  • Robin L. Washington - CFO & Executive VP

    Robin L. Washington - CFO & Executive VP

  • Perfect. And Ronny, I also wanted to go back to the other component that, that HIV line also includes prevention, right, so PrEP. So to your point, there is that impact on the average price per patient because it's not the STR, you're looking at the Descovy component of that, right, so that would also impact average price per patient as PrEP usage -- as PrEP usage continues to go up as well.

    完美的。羅尼,我還想回到另一個方面,那就是愛滋病毒防治也包括預防,對吧,例如 PrEP。所以正如你所說,這會對每位患者的平均價格產生影響,因為這不是 STR,而是 Descovy 部分,對吧?因此,隨著 PrEP 使用量的持續成長,這也會對每位患者的平均價格產生影響。

  • Operator

    Operator

  • Thank you. This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Sung Lee for any further remarks.

    謝謝。今天的問答環節到此結束。我想把發言權交還給李成,請他再補充一些內容。

  • Sung Lee - VP of IR

    Sung Lee - VP of IR

  • Thank you, Jonathan, and thank you all for joining us today. We appreciate your continued interest in Gilead, and the team here looks forward to providing you with updates on our future progress.

    謝謝你,喬納森,也謝謝各位今天蒞臨現場。我們感謝您一直以來對吉利德的關注,我們的團隊期待向您報告我們未來的進展。

  • Operator

    Operator

  • Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

    感謝各位女士、先生參加今天的會議。節目到此結束。您現在可以斷開連線了。再會。