(ILMN) 2022 Q4 法說會逐字稿

內容摘要

2022 年第四季度,Illumina Inc. 的運營現金流為 1.47 億美元。資本支出為 8800 萬美元,自由現金流為 5900 萬美元。公司本季度未回購任何普通股。截至本季度末,公司擁有 20 億美元的現金、現金等價物和短期投資,其中包括 2022 年 12 月 13 日發行的定期票據的淨收益 9.91 億美元,將用於償還即將到期的債務2023.

到 2023 年,公司預計全年綜合收入將增長 7% 至 10%,達到約 49 億美元至 50.3 億美元。 Core Illumina 的收入預計將增長 6% 至 9%,達到約 48.3 億美元至 49.6 億美元。這些範圍包括來自 COVID 監測的預期逆風約 200 個基點,以及來自外匯匯率的同比逆風。預計到 2023 年季度收入將連續增加,其線性趨勢類似於 2017 年推出 NovaSeq 6000 時所看到的情況。 GRAIL 預計 2023 年的收入將在 9000 萬至 1.1 億美元之間,反映出在 Galleri 測試加速採用的推動下,中點同比增長 82%。 Core Illumina 收入預計在 2023 財年同比增長 8-9%。這包括向 GRAIL 的 3500 萬美元公司間銷售額,這些銷售額在合併中被抵銷。在 NovaSeq X 升級週期和中等通量持續增長的推動下,Core Illumina 測序儀器預計同比增長 9%。 Core Illumina 測序耗材預計同比增長 8%,這主要是受 NovaSeq X 推出的推動,因為客戶建立耗材庫存和提高利用率,以及由於安裝基礎不斷增長而導致的中等通量耗材持續增長。這一增長將部分被 COVID 監測收入的進一步減少所抵消。

隨著客戶轉向 NovaSeq X,NovaSeq 6000 的年收入預計在 2023 年達到每個系統 90 萬至 100 萬美元。NextSeq 1000/2000 的收入預計在每個系統 12 萬至 17 萬美元之間2023 年,隨著 22 年創紀錄的樂器放置和 2023 年持續強勁的放置完全上線。 Illumina 的剩餘突破範圍預計將符合歷史指導。 Illumina Inc. 計劃在海沃德擁有一個人員配備齊全的儀器製造工廠,並在 2022 年第四季度提高產量和產能。他們預計屆時將在生產過程的各個階段擁有超過 60 台 NovaSeq X 儀器,以及所有一級和二級測序指標達到或超過規格。

此外,他們已採取措施確保其供應鏈強大。他們在 2 年前開始增加和加入新的供應商,以確保材料和組件的供應,從而推動 NovaSeq X 的生產。

他們還裝備了他們的全球商業團隊,以便在他們的客戶收到第一批 NovaSeq X 貨物時為他們提供指導。 1 月,他們召集了 800 多名銷售團隊成員參加了為期 3 天的培訓課程,為他們提供了新的工具和見解,以支持客戶使用這種功能強大的新儀器加速全球基因組學。

該團隊充滿活力地將這些新功能推向市場,並很高興看到多年準備的成果。他們相信,他們組織的規模、影響力和經驗將使他們的客戶能夠比以往對更多樣品進行測序、進行更多分析並獲得更多數據。 NovaSeq X 釋放了更大的彈性,他們預計隨著時間的推移,X 的平均 pull-through 將輕鬆超過 NovaSeq 6000。到 2023 年,Illumina Inc. 預計 COVID 監測的收入約為 3000 萬美元。然而,這被 1.05 億美元的不利因素所抵消,即同比增長約 2 個百分點。該公司預計 2023 年核心 Illumina 非 GAAP 營業利潤率約為 22% 的合併非 GAAP 營業利潤率約為 8%。這些利潤率反映: Illumina 核心營業費用從 2022 年開始增加,主要受業績正常化的推動-基於補償;隨著公司推出 NovaSeq X,毛利率暫時下降,與 2017 年推出 NovaSeq 6000 時的情況一致;由於為支持 FDA 申請、NHS 試驗和繼續擴大 GRAIL 的商業組織而進行的持續投資,導致 GRAIL 運營費用增加。該公司預計綜合非 GAAP 稅率約為 36%,其中包括研發資本化要求帶來的約 7500 萬美元的影響。如果這些要求在 2023 年被廢除,公司預計其 2023 年的非 GAAP 稅率約為 15%。該公司預計合併的非 GAAP 每股攤薄收益在 1.25 美元至 1.50 美元之間,其中包括 GRAIL 約 6.7 億美元的非 GAAP 運營虧損的攤薄收益。最後,該公司預計 2023 財年的非 GAAP 稀釋流通股約為 1.6 億股。 2022 年第四季度,Illumina 實現了約 11 億美元的收入。 2022 年全年,公司實現收入約 46 億美元,符合修訂後指導範圍的上限。

該公司在這一年中放置了 3,200 多台儀器,將其全球安裝基數增加到大約 23,000 台儀器。

NovaSeq X 系列的推出非常成功,在全球範圍內引起了濃厚的興趣,訂單來自超過 25 個國家。由於 NovaSeq X 的易用性和成本優勢,該公司已經看到強大的臨床採用和來自新客戶到高通量客戶的訂單,這些客戶正在內部進行測序。

NovaSeq X 擁有所有 Illumina 儀器發布中最強勁的預訂單,這種需求將促進多年的升級週期。

該公司在 2022 年出貨了 340 多台 NovaSeq 6000,其中超過 1/3 的儀器用於腫瘤學檢測,近一半是新的高通量或新的 Illumina 客戶。

即使在創紀錄的 2021 年之後,2022 年上半年的安置也很強勁。下半年的安置因客戶對 NovaSeq X 系列的興奮度越來越高而有所緩和。

到 2022 年,NovaSeq 6000 的平均耗材消耗約為每台儀器 100 萬美元。 Illumina 是一家生產用於 DNA 測序的產品的公司。該公司的新 X 系列產品較之前的產品有了顯著改進,並因其卓越的性能和成本而受到客戶的青睞。但是,客戶正在等待從渠道轉換為訂單,因為他們需要確認產品預算。 Illumina Inc. 預計客戶會隨著時間的推移訂購 X。該公司目前有超過 155 種儀器處於預購狀態,超過 250 種處於高級管道中。

公司預計與 2022 年第四季度相比,2023 年第一季度的綜合收入將有所下降,這主要是由於季節性因素和 GRAIL 收入的減少。然而,Illumina Inc. 預計到 2023 年季度收入將連續增長,其推動因素包括 NovaSeq X 出貨量和利用率的上升、中國從 COVID 中斷中恢復、Galleri 的加速採用以及 2023 年下半年宏觀經濟逆風的預期緩解. 對於第一季度,公司預計非 GAAP 營業利潤率約為 1%,核心 Illumina 非 GAAP 營業利潤率約為 17%。公司預計淨其他費用約為 900 萬美元,主要是由於新債券發行的利息費用。最後,公司預計非 GAAP 稀釋流通股約為 1.6 億股,與 2023 財年持平。Illumina 2022 年第四季度的收入為 10.8 億美元,比上年下降 10%。該公司將這種下降歸因於 COVID 大流行的持續影響以及客戶庫存管理和匯率導致對其產品的需求下降。由測序耗材組成的核心 Illumina 收入同比下降 11%。該公司的非 GAAP 收益為 2200 萬美元,或每股攤薄收益 0.14 美元,其中包括 GRAIL 本季度 1.59 億美元的非 GAAP 運營虧損的攤薄收益。由於研發資本化要求的影響,公司本季度的非美國通用會計準則稅率為 29.3%,全年為 26%,高於 2021 年第四季度的 15.6% 和 2021 財年的 17.3%。

Illumina 總裁兼首席執行官 Francis deSouza 發表了最後的講話。他談到了 Illumina 如何繼續優先考慮創新。他談到了 NovaSeq X 系列,以及它如何成為 2023 年及以後的強大催化劑。他談到他們也很高興通過 Illumina Complete Long-Reads 產品中的 2 款即將推出的產品將長讀長功能推向市場。他談到了他們的 long-read 人類全基因組分析將如何在今年上半年可用,而富集面板將在今年下半年可用。他談到了富集面板如何以低至每個基因組 600 美元的價格實現全面、高精度、長讀長的視圖。他談到了十多個客戶如何使用 Illumina Complete Long-Reads 評估他們自己樣本的數據,他們的反饋非常積極。

完整原文

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

  • Operator

    Operator

  • Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2022 Illumina Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

    女士們先生們,美好的一天,歡迎來到 Illumina 2022 年第四季度收益電話會議。 (操作員說明)請注意,今天的會議正在錄製中。

  • I would now like to hand the conference over to Salli Schwartz, Vice President of Investor Relations.

    我現在想將會議交給投資者關係副總裁 Salli Schwartz。

  • Sallilyn Schwartz - VP of IR

    Sallilyn Schwartz - VP of IR

  • Hello, everyone, and welcome to our earnings call for the fourth quarter and year-end 2022. During the call today, we will review the financial results released after the close of the market and offer commentary on our commercial activity, after which we will host a question-and-answer session. If you have not had a chance to review the earnings release, it can be found in the Investor Relations section of our website at illumina.com.

    大家好,歡迎參加我們 2022 年第四季度和年底的財報電話會議。在今天的電話會議中,我們將回顧收市後發布的財務業績,並對我們的商業活動發表評論,之後我們將主持問答環節。如果您還沒有機會查看收益發布,可以在我們網站 illumina.com 的投資者關係部分找到它。

  • Participating for Illumina today will be Francis deSouza, President and Chief Executive Officer; and Joydeep Goswami, Chief Financial Officer and Chief Strategy and Corporate Development Officer. Francis will provide an update on the state of Illumina's business, and Joydeep will review our financial results, which include GRAIL. As a reminder, GRAIL must be held and operated separately and independently from Illumina, pursuant to the interim measures ordered by the European Commission, which prohibited our acquisition of GRAIL under the EU merger regulation.

    今天參加 Illumina 會議的有總裁兼首席執行官 Francis deSouza;首席財務官兼首席戰略和企業發展官 Joydeep Goswami。 Francis 將提供有關 Illumina 業務狀況的最新信息,Joydeep 將審查我們的財務業績,其中包括 GRAIL。提醒一下,根據歐盟委員會下令禁止我們根據歐盟合併法規收購 GRAIL 的臨時措施,GRAIL 必須與 Illumina 分開持有和獨立運營。

  • This call is being recorded, and the audio portion will be archived in the Investors section of our website. It is our intent that all forward-looking statements regarding our financial results and commercial activity made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon current available information, and Illumina assumes no obligation to update those statements.

    此通話正在錄音中,音頻部分將存檔在我們網站的“投資者”部分。我們打算在今天的電話會議中就我們的財務業績和商業活動作出的所有前瞻性陳述將受到 1995 年私人證券訴訟改革法案的保護。前瞻性陳述受風險和不確定性的影響。實際事件或結果可能與預測或討論的事件或結果存在重大差異。所有前瞻性陳述均基於當前可用信息,Illumina 不承擔更新這些陳述的義務。

  • To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Illumina files with the Securities and Exchange Commission, including Illumina's most recent Forms 10-Q and 10-K.

    為了更好地理解可能導致實際結果不同的風險和不確定性,我們建議您參閱 Illumina 向美國證券交易委員會提交的文件,包括 Illumina 最新的 10-Q 和 10-K 表格。

  • With that, I'll now turn the call over to Francis.

    有了這個,我現在將電話轉給弗朗西斯。

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • Thank you, Salli. Good afternoon, everyone. 2023 is off to an exciting start for Illumina and for genomics, and I'm pleased to announce that we've started shipping the first NovaSeq X Plus systems to customers. Later in my remarks, I'll share how we're scaling our manufacturing and distribution infrastructure to ship 40 to 50 units in Q1 and over 300 units for the year.

    謝謝你,莎莉。大家下午好。 2023 年對於 Illumina 和基因組學來說是一個激動人心的開端,我很高興地宣布,我們已經開始向客戶交付首批 NovaSeq X Plus 系統。在稍後的發言中,我將分享我們如何擴展我們的製造和分銷基礎設施,以在第一季度出貨 40 到 50 台,全年出貨量超過 300 台。

  • First, I'll cover our financial results for both the fourth quarter and full year 2022. Illumina delivered fourth quarter revenue of approximately $1.1 billion and full year 2022 revenue of approximately $4.6 billion, in line with the upper end of our revised guidance range. We placed more than 3,200 instruments in 2022, increasing our installed base to approximately 23,000 instruments worldwide.

    首先,我將介紹我們 2022 年第四季度和全年的財務業績。Illumina 第四季度的收入約為 11 億美元,2022 年全年的收入約為 46 億美元,符合我們修訂後的指導範圍的上限。我們在 2022 年放置了 3,200 多台儀器,使我們在全球的安裝基數增加到大約 23,000 台儀器。

  • Delving now into each of our platforms, starting with high-throughput. We've had a fantastic customer response to the NovaSeq X series launch. Both orders and the advanced pipeline continue to grow. There's strong global interest with orders from more than 25 countries, 4x more than in the first quarter of the NovaSeq 6000 launch. We're also seeing stronger-than-expected clinical adoption and orders from new to high-throughput customers who are bringing sequencing in-house due to NovaSeq X's ease of use and cost benefits.

    現在深入研究我們的每個平台,從高吞吐量開始。客戶對 NovaSeq X 系列的發布反響非常好。訂單和先進的管道都在繼續增長。來自超過 25 個國家的訂單引起了全球的濃厚興趣,比 NovaSeq 6000 發布的第一季度多了 4 倍。由於 NovaSeq X 的易用性和成本優勢,我們還看到來自新客戶和高通量客戶的臨床採用和訂單強於預期,這些客戶正在內部進行測序。

  • The NovaSeq X has had the strongest pre-order book of any Illumina instrument launch, and this demand will catalyze a multiyear upgrade cycle. We also shipped more than 340 NovaSeq 6000s in 2022, with more than 1/3 of those instruments for oncology testing and nearly half to new to high-throughput or new to Illumina customers. Placements were strong in the first half of 2022 even after a record 2021. Second half placements were tempered by growing customer excitement for the NovaSeq X series. Across 2022, average consumable pull-through for the NovaSeq 6000 was approximately $1 million per instrument.

    NovaSeq X 擁有所有 Illumina 儀器發布中最強勁的預訂單,這種需求將促進多年的升級週期。我們還在 2022 年出貨了 340 多台 NovaSeq 6000,其中超過 1/3 的儀器用於腫瘤學測試,近一半是新的高通量或新的 Illumina 客戶。即使在創紀錄的 2021 年之後,2022 年上半年的安置也很強勁。下半年的安置因客戶對 NovaSeq X 系列的興奮度越來越高而有所緩和。到 2022 年,NovaSeq 6000 的平均耗材消耗約為每台儀器 100 萬美元。

  • Moving to mid-throughput. In 2022, we shipped a record 1,215 instruments and saw the fourth consecutive record year for NextSeq shipments. The fourth quarter of 2022 was also the highest quarter on record for NextSeq 1000/2000 shipments. Customers appreciate NextSeq 1000/2000's unique capabilities as the only mid-throughput sequencer with built-in analysis and the first mid-throughput instrument to include the 2x300 kits. Close to 25% of NextSeq 1000/2000 units in 2022 were placed with new to Illumina customers.

    轉向中等吞吐量。 2022 年,我們出貨了創紀錄的 1,215 台儀器,NextSeq 出貨量連續第四年創歷史新高。 2022 年第四季度也是 NextSeq 1000/2000 出貨量創歷史新高的季度。客戶欣賞 NextSeq 1000/2000 的獨特功能,因為它是唯一一款具有內置分析功能的中等通量測序儀,也是第一款包含 2x300 套件的中等通量儀器。到 2022 年,近 25% 的 NextSeq 1000/2000 單元被 Illumina 的新客戶放置。

  • For low-throughput, in 2022, we shipped approximately 1,670 instruments, bringing nearly 700 new customers to Illumina. Our low-throughput instruments consistently open new geographies and applications while serving as an effective entry point to sequencing.

    對於低通量,我們在 2022 年出貨了大約 1,670 台儀器,為 Illumina 帶來了近 700 個新客戶。我們的低通量儀器不斷開闢新的地域和應用,同時作為測序的有效切入點。

  • Shifting to our markets. Our clinical markets currently include testing for oncology, reproductive health and genetic disease. In 2022, shipments to clinical customers represented 45% of core Illumina consumables. For 2022, oncology testing consumables grew 7% year-over-year from utilization of MGS-based molecular profiling across early detection, therapy selection and minimal residual disease. We see expanding opportunities for our oncology products globally. For our TruSight Oncology 500 distributed therapy selection assay, sample volume grew approximately 60% year-over-year across more than 500 accounts. And for 2023, we expect more than $100 million in revenue for TSO 500.

    轉向我們的市場。我們的臨床市場目前包括腫瘤學、生殖健康和遺傳病檢測。 2022 年,向臨床客戶的出貨量佔 Illumina 核心耗材的 45%。到 2022 年,由於在早期檢測、治療選擇和微小殘留病方面使用基於 MGS 的分子譜分析,腫瘤檢測耗材同比增長 7%。我們看到我們的腫瘤產品在全球範圍內不斷擴大的機會。對於我們的 TruSight Oncology 500 分佈式治療選擇分析,500 多個賬戶的樣本量同比增長約 60%。到 2023 年,我們預計 TSO 500 的收入將超過 1 億美元。

  • Also in oncology, GRAIL continues to have strong demand from consumers, physicians, health systems and payers. Galleri is the only multi-cancer early detection test in a $40-plus billion market, and it had the fastest first year revenue ramp in cancer screening test history. GRAIL has established over 60 partnerships with leading health systems, self-insured employers and other health care stakeholders. In 2022 alone, more than 4,500 providers ordered the test, contributing to the more than 60,000 Galleri test orders that have been received to date.

    同樣在腫瘤學領域,GRAIL 繼續受到消費者、醫生、衛生系統和付款人的強烈需求。 Galleri 是一個超過 400 億美元的市場中唯一的多癌症早期檢測測試,它在癌症篩查測試歷史上的第一年收入增長最快。 GRAIL 已與領先的衛生系統、自保雇主和其他醫療保健利益相關者建立了 60 多個合作夥伴關係。僅在 2022 年,就有超過 4,500 家供應商訂購了測試,迄今為止已收到超過 60,000 份 Galleri 測試訂單。

  • The Galleri test has received FDA Breakthrough Designation and was recognized by Time as one of the best inventions of 2022, by The Atlantic as one of the Breakthroughs of the Year and by Fast Company as one of the world-changing ideas of 2022. Galleri was also featured in an AARP health story on game-changing medical breakthroughs, improving lives today. GRAIL expects this exciting momentum to continue and to translate into an expected revenue CAGR of 60% to 90% over the next 5 years.

    Galleri 測試已獲得 FDA 的突破性指定,並被時代雜誌評為 2022 年最佳發明之一,被大西洋雜誌評為年度突破之一,被 Fast Company 評為 2022 年改變世界的創意之一。Galleri 是還出現在 AARP 健康故事中,講述了改變遊戲規則的醫學突破,改善了當今的生活。 GRAIL 預計這種令人興奮的勢頭將持續下去,並在未來 5 年內轉化為 60% 至 90% 的預期收入複合年增長率。

  • Beyond oncology, genetic disease testing had a record quarter in Q4 and another strong year in 2022. For 2022, GDT consumable shipments grew 11% year-over-year, driven by broader adoption of whole genome sequencing globally and increased demand for rare disease treatment. We also saw additional evidence generation, with the European Society of Human Genetics updating its guidelines to recommend increased adoption of whole genome sequencing in diagnostics as well as increased coverage for rare and undiagnosed genetic diseases. Recently, 2 of the largest health insurance companies in the U.S., based on the number of patients served, announced that whole genome sequencing will be covered for patients with rare and undiagnosed genetic diseases, starting this quarter.

    除了腫瘤學,遺傳疾病檢測在第四季度創下了創紀錄的季度業績,2022 年又是一個強勁的年份。到 2022 年,GDT 耗材出貨量同比增長 11%,這得益於全球範圍內更廣泛地採用全基因組測序以及對罕見疾病治療的需求增加.我們還看到了更多的證據生成,歐洲人類遺傳學學會更新了其指南,建議在診斷中更多地採用全基因組測序,並增加對罕見和未確診遺傳病的覆蓋率。近日,美國最大的兩家健康保險公司,根據服務的患者數量,宣布將從本季度開始,為患有罕見和未確診遺傳病的患者提供全基因組測序服務。

  • And AIM Specialty Health, which provides lab benefits management services for more than a dozen regional health plans in the U.S. now considers comprehensive genomic profiling medically necessary for appropriate patients with advanced cancers. Tens of millions more Americans will be covered, a huge win for patients and our customers and for Illumina.

    AIM Specialty Health 為美國十多個區域健康計劃提供實驗室福利管理服務,現在認為全面的基因組分析對於適當的晚期癌症患者來說具有醫學上的必要性。將覆蓋數千萬美國人,這對患者和我們的客戶以及 Illumina 來說都是巨大的勝利。

  • Turning to our research and applied markets. Consumable shipments represented 55% of core Illumina consumables in 2022. Boosting the diversity in genetic databases is a significant need for our customers as they work to understand the underlying cause of disease. Genomics, combined with clinical information, can increase drug discovery success by up to 150% and reduce costs by up to 50%. To achieve this, we need more samples over time and for more diverse populations. We recently announced an agreement with Amgen and its subsidiary, deCODE Genetics, to sequence the first 35,000 genomes in our collaboration with Nashville Biosciences. This sample cohort will represent the largest data set of African-Americans to date as we aim to accelerate equitable access to precision health therapies, and they've already begun sequencing the first samples.

    轉向我們的研究和應用市場。 2022 年,耗材出貨量佔 Illumina 核心耗材的 55%。提高基因數據庫的多樣性是我們客戶的一項重要需求,因為他們正在努力了解疾病的根本原因。基因組學與臨床信息相結合,可以將藥物發現的成功率提高多達 150%,並將成本降低多達 50%。為實現這一目標,隨著時間的推移,我們需要更多的樣本,以獲取更多樣化的人群。我們最近宣布與 Amgen 及其子公司 deCODE Genetics 達成協議,在我們與 Nashville Biosciences 的合作中對前 35,000 個基因組進行測序。這個樣本隊列將代表迄今為止最大的非裔美國人數據集,因為我們的目標是加速公平獲得精準健康療法,他們已經開始對第一批樣本進行測序。

  • Moving now to 2023. We're excited for this launch year and have now started shipping NovaSeq X Plus systems to our first customers. We're on track to ship 40 to 50 NovaSeq X instruments in Q1 and more than 300 instruments in 2023. To accomplish this, we boosted our operational capabilities. We've built state-of-the-art consumable manufacturing facilities in the U.K., Singapore and San Diego, adding 9 new production lines. At launch, we already have 2 to 3 months of inventory for each of the 6 core consumable SKUs.

    現在轉到 2023 年。我們對這個發布年感到興奮,現在已經開始向我們的第一批客戶運送 NovaSeq X Plus 系統。我們有望在第一季度出貨 40 到 50 台 NovaSeq X 儀器,並在 2023 年出貨 300 多台儀器。為實現這一目標,我們提高了運營能力。我們在英國、新加坡和聖地亞哥建立了最先進的耗材製造設施,新增了 9 條生產線。在發佈時,我們已經為 6 個核心消耗品 SKU 中的每一個準備了 2 到 3 個月的庫存。

  • In our instrument manufacturing facility in Hayward, we are fully staffed and ramping up production and capacity. Right now, there are more than 60 NovaSeq X instruments in various stages of the production process. All primary and secondary sequencing metrics are meeting or exceeding specifications. In addition, we've taken steps to ensure our supply chain is strong. We began adding and onboarding new suppliers 2 years ago to secure the material and component supply fueling NovaSeq X production. We're also equipping our global commercial team to guide our customers as they receive the first NovaSeq X shipments. In January, we brought together more than 800 sales team members in a 3-day training session, giving them new tools and insights to support customers as they accelerate genomics worldwide with this powerful new instrument.

    在我們位於海沃德的儀器製造工廠,我們人員配備齊全,正在提高產量和產能。目前,有超過 60 台 NovaSeq X 儀器處於生產過程的各個階段。所有一級和二級測序指標均達到或超過規格。此外,我們已採取措施確保我們的供應鏈強大。 2 年前,我們開始增加和加入新的供應商,以確保為 NovaSeq X 生產提供燃料和組件供應。我們還裝備了我們的全球商業團隊,以便在我們的客戶收到第一批 NovaSeq X 貨物時為他們提供指導。 1 月,我們召集了 800 多名銷售團隊成員參加了為期 3 天的培訓課程,為他們提供了新的工具和見解,以支持客戶使用這種功能強大的新儀器加速全球基因組學。

  • The team is energized to bring these new capabilities to market and excited to see the outcome of years of preparation. We are confident that our organization's scale, reach and experience will enable our customers to sequence more samples, run more analyses and obtain more data than ever before. And NovaSeq X unlocks greater elasticity, we expect average pull-through for the X to comfortably exceed NovaSeq 6000 over time.

    該團隊充滿活力地將這些新功能推向市場,並很高興看到多年準備的成果。我們相信,我們組織的規模、影響力和經驗將使我們的客戶能夠比以往對更多樣品進行測序、進行更多分析並獲得更多數據。 NovaSeq X 釋放了更大的彈性,我們預計隨著時間的推移,X 的平均 pull-through 將輕鬆超過 NovaSeq 6000。

  • Illumina will remain focused on supporting our valued customers with transformative innovations and continue to advance our road map to accelerate the genome era. Customers' interest worldwide continues to be very strong, and they are eager to harness the capabilities of the X, the most powerful, most sustainable and most cost-effective sequencer ever developed to further unlock the power of the genome. You'll hear more about the customer experience and data at AGBT this week.

    Illumina 將繼續專注於通過變革性創新支持我們尊貴的客戶,並繼續推進我們的路線圖以加速基因組時代的到來。全球客戶的興趣仍然非常濃厚,他們渴望利用 X 的功能,這是迄今為止開發的最強大、最可持續和最具成本效益的測序儀,以進一步釋放基因組的力量。本週您將在 AGBT 上聽到更多關於客戶體驗和數據的信息。

  • Now before I turn the call over to Joydeep, I'd like to thank him and welcome him to the role as Illumina's Chief Financial Officer. With over 2 decades experience in the industry, Joydeep brings strategic expertise, deep industry knowledge and extensive global business experience to the role. He is a proven and disciplined leader with a strong track record of creating value and an ideal partner to help drive the next phase of Illumina's growth.

    現在,在我將電話轉給 Joydeep 之前,我要感謝他並歡迎他擔任 Illumina 的首席財務官。 Joydeep 擁有超過 20 年的行業經驗,為該職位帶來了戰略專長、深厚的行業知識和廣泛的全球業務經驗。他是一位久經考驗、紀律嚴明的領導者,在創造價值方面有著良好的記錄,是幫助推動 Illumina 下一階段發展的理想合作夥伴。

  • I'll now turn the call over to Joydeep for more detail on the quarter and our full year outlook.

    我現在將電話轉給 Joydeep,以了解有關本季度和全年展望的更多詳細信息。

  • Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

    Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

  • Thanks, Francis, and thanks for the kind introduction. I'm excited to step into the role on a permanent basis and continue to work with all of you. I'll start by reviewing our consolidated financial results, followed by segment results for core Illumina and GRAIL, and conclude with additional remarks on our current outlook for 2023. I will be discussing non-GAAP results, which include stock-based compensation. I encourage you to review the GAAP reconciliation of these non-GAAP measures, which can be found in today's release and in supplementary data available on our website.

    謝謝,弗朗西斯,感謝您的友好介紹。我很高興能永久擔任這個角色,並繼續與大家一起工作。我將首先回顧我們的綜合財務業績,然後是核心 Illumina 和 GRAIL 的分部業績,最後是對我們目前 2023 年展望的補充評論。我將討論非 GAAP 業績,其中包括基於股票的薪酬。我鼓勵您查看這些非 GAAP 措施的 GAAP 調節,這些可以在今天的新聞稿和我們網站上提供的補充數據中找到。

  • In the fourth quarter, consolidated revenue was $1.08 billion, down 10% year-over-year or down 7% on a constant currency basis, net of the effects of hedging. Non-GAAP earnings were $22 million or $0.14 per diluted share, including dilution from GRAIL's non-GAAP operating loss of $159 million for the quarter. Non-GAAP earnings per share were lower than expected due to approximately $87 million in incremental tax expense from the R&D capitalization requirements that were not repealed in Q4 2022 despite broad bipartisan support. The incremental tax expense includes approximately $80 million recorded in Q1 through Q3 that was ultimately not reversed in Q4.

    第四季度,合併收入為 10.8 億美元,同比下降 10%,或按固定匯率計算下降 7%,扣除對沖的影響。非 GAAP 收益為 2200 萬美元或每股攤薄收益 0.14 美元,包括 GRAIL 本季度 1.59 億美元的非 GAAP 運營虧損的攤薄收益。非 GAAP 每股收益低於預期,原因是研發資本化要求產生了約 8700 萬美元的增量稅費,儘管得到了兩黨的廣泛支持,但該要求並未在 2022 年第四季度廢除。增量稅費包括從第一季度到第三季度記錄的大約 8000 萬美元,這些費用最終在第四季度沒有逆轉。

  • Our non-GAAP tax rate was 29.3% for the quarter and 26% for the full year 2022, which increased from 15.6% in Q4 2021 and 17.3% in fiscal year 2021, primarily due to the impact of R&D capitalization requirements. Our non-GAAP weighted average diluted share count for the quarter was approximately 158 million.

    我們的非 GAAP 稅率在本季度為 29.3%,在 2022 年全年為 26%,高於 2021 年第四季度的 15.6% 和 2021 財年的 17.3%,這主要是由於研發資本化要求的影響。我們本季度的非 GAAP 加權平均攤薄股數約為 1.58 億股。

  • Moving to segment results. I'll start by discussing the financial results of core Illumina. Core Illumina revenue was $1.07 billion, down 11% year-over-year or down 8% on a constant currency basis, net of the effects of hedging. Core Illumina sequencing consumables revenue of $687 million was down 13% year-over-year. As expected, growth driven by pull-through on the increased installed base was offset by delayed recruitment for some large research projects in the Americas and Europe, the ongoing impact of COVID disruptions in China, the year-over-year impact of customer inventory management, the anticipated decrease in COVID surveillance revenue and headwinds from foreign exchange rates.

    移動到細分結果。我將從討論核心 Illumina 的財務結果開始。核心 Illumina 收入為 10.7 億美元,同比下降 11%,或按固定匯率計算下降 8%,扣除對沖的影響。核心 Illumina 測序耗材收入為 6.87 億美元,同比下降 13%。正如預期的那樣,由安裝基礎增加帶來的拉動推動的增長被美洲和歐洲一些大型研究項目的延遲招聘、中國 COVID 中斷的持續影響、客戶庫存管理的同比影響所抵消、COVID 監測收入的預期減少和外匯匯率的不利因素。

  • Sequencing instruments revenue for core Illumina declined 24% year-over-year to $146 million, driven primarily by the lower NovaSeq 6000 shipments in advance of the availability of NovaSeq X. The decline was partially offset by another quarter of record NextSeq 1000/2000 shipments, which grew 31% year-over-year as we continue to see strong adoption by new to Illumina customers and demand for our new 2x300 kits that bring longer lead capabilities to our mid-throughput platform for the first time.

    核心 Illumina 的測序儀器收入同比下降 24% 至 1.46 億美元,這主要是由於 NovaSeq X 上市前 NovaSeq 6000 出貨量下降。這一下降被 NextSeq 1000/2000 出貨量創紀錄的另一個季度部分抵消,同比增長 31%,因為我們繼續看到 Illumina 新客戶的強烈採用,以及對我們新的 2x300 套件的需求,這些套件首次為我們的中通量平台帶來了更長的先導能力。

  • During the fourth quarter, COVID surveillance contributed approximately $20 million in total revenue, comprised of $19 million in sequencing consumables and $1 million in sequencing instruments. This was in line with our expectations and down $30 million year-over-year, driven primarily by lower sample volumes. Core Illumina sequencing service and other revenue of $131 million was up 24% year-over-year, driven primarily by higher instrument service contract revenue on a growing installed base as well as an increase in oncology and IBD partnership revenue.

    第四季度,COVID 監測貢獻了約 2000 萬美元的總收入,其中包括 1900 萬美元的測序耗材和 100 萬美元的測序儀器。這符合我們的預期,同比減少 3000 萬美元,主要是由於樣品量減少。核心 Illumina 測序服務和其他收入為 1.31 億美元,同比增長 24%,這主要是由於安裝基礎不斷增長帶來的儀器服務合同收入增加以及腫瘤學和 IBD 合作夥伴收入的增加。

  • Moving to regional results for core Illumina. Revenue for the Americas was $577 million, down 7% year-over-year, and EMEA revenue of $301 million represented a 14% decrease year-over-year or a 10% decrease on a constant currency basis. As expected, the base business in both regions was impacted by an anticipation for NovaSeq X and the slowdown in COVID surveillance and research I mentioned earlier. We continue to see strong demand for NextSeq 1000/2000, with record shipments in the Americas up nearly 50% year-over-year, driven by strength across both research and clinical. In addition, NovaSeq Dx shipments exceeded expectations in the first quarter of launch with strong early demand by clinical customers in Europe.

    轉到核心 Illumina 的區域結果。美洲收入為 5.77 億美元,同比下降 7%,EMEA 收入為 3.01 億美元,同比下降 14%,按固定匯率計算下降 10%。正如預期的那樣,這兩個地區的基礎業務都受到了對 NovaSeq X 的預期以及我之前提到的 COVID 監測和研究放緩的影響。我們繼續看到對 NextSeq 1000/2000 的強勁需求,在研究和臨床實力的推動下,美洲的出貨量同比增長近 50%。此外,由於歐洲臨床客戶的早期需求強勁,NovaSeq Dx 上市第一季度的出貨量超出了預期。

  • Greater China revenue of $94 million represented a 22% decrease year-over-year or a 14% decrease on a constant currency basis. The region continued to be impacted by COVID lockdowns that resulted in lower sample volumes year-over-year. We continue to expect our business in China to be impacted by headwinds from COVID-related disruptions, exchange rates and slowing GDP growth in the region, at least through the first half of 2023. Finally, APJ revenue of $93 million declined 10% year-over-year or 4% on a constant currency basis, net of the effects of hedges. Strong growth across clinical markets was more than offset by the conclusion of a large research project in Japan and delayed high-throughput instrument purchases due to the introduction of NovaSeq X.

    大中華區收入為 9400 萬美元,同比下降 22%,按固定匯率計算下降 14%。該地區繼續受到 COVID 封鎖的影響,導致樣本量同比下降。我們繼續預計,至少到 2023 年上半年,我們在中國的業務將受到 COVID 相關中斷、匯率和該地區 GDP 增長放緩帶來的逆風的影響。最後,APJ 收入為 9300 萬美元,同比下降 10%-扣除對沖影響後,按固定匯率計算同比增長或 4%。臨床市場的強勁增長被日本大型研究項目的結束和由於 NovaSeq X 的推出而延遲的高通量儀器採購所抵消。

  • Moving to the rest of core Illumina P&L. Core Illumina non-GAAP gross margin of 67.3% decreased 430 basis points year-over-year, primarily due to less fixed cost leverage on lower manufacturing volumes. Core Illumina non-GAAP operating expenses of $528 million were down $52 million year-over-year, primarily due to cost containment initiatives, lower performance-based compensation expense and a onetime partnership-related expense in Q4 2021.

    轉到核心 Illumina P&L 的其餘部分。 Core Illumina 非 GAAP 毛利率為 67.3%,同比下降 430 個基點,這主要是由於較低的製造量導致固定成本槓桿率較低。核心 Illumina 非 GAAP 運營費用為 5.28 億美元,同比下降 5200 萬美元,這主要是由於成本控制計劃、較低的基於績效的薪酬費用以及 2021 年第四季度的一次性合作相關費用。

  • Transitioning to the financial results for GRAIL. GRAIL revenue of $23 million for the quarter grew 130% year-over-year, driven primarily by accelerating adoption of Galleri as well as higher contributions from MRD pharma partnerships due to a milestone payment in Q4 '22 that GRAIL does not expect to repeat in Q1 2023. GRAIL non-GAAP operating expenses totaled $166 million and increased $35 million year-over-year, driven primarily by continued investments in clinical trials and to scale GRAIL's commercial organization.

    過渡到 GRAIL 的財務結果。 GRAIL 本季度的收入為 2300 萬美元,同比增長 130%,這主要是由於 Galleri 的加速採用以及 MRD 製藥合作夥伴的貢獻增加,這是由於 GRAIL 預計不會在 22 年第四季度支付的里程碑付款2023 年第一季度。GRAIL 非 GAAP 運營費用總計 1.66 億美元,同比增加 3500 萬美元,這主要是由於對臨床試驗的持續投資和擴大 GRAIL 的商業組織。

  • Moving to consolidated cash flow and balance sheet items. Cash flow provided by operations was $147 million. Fourth quarter 2022 capital expenditures were $88 million and free cash flow was $59 million. We did not repurchase any common stock in the quarter. We ended the quarter with approximately $2 billion in cash, cash equivalents and short-term investments. Cash as of the close of the quarter included $991 million in net proceeds from the term notes issued on December 13, 2022, which will be used to repay upcoming debt maturities in 2023.

    轉向合併現金流量和資產負債表項目。運營提供的現金流量為 1.47 億美元。 2022 年第四季度資本支出為 8800 萬美元,自由現金流為 5900 萬美元。本季度我們沒有回購任何普通股。本季度末,我們擁有約 20 億美元的現金、現金等價物和短期投資。截至本季度末的現金包括 2022 年 12 月 13 日發行的定期票據的淨收益 9.91 億美元,這些票據將用於償還 2023 年即將到期的債務。

  • Moving now to 2023 guidance. We expect full year consolidated revenue to grow 7% to 10% to approximately $4.9 billion to $5.03 billion. We expect full year 2023 core Illumina revenue to grow 6% to 9% to approximately $4.83 billion to $4.96 billion. These ranges include an anticipated headwind from COVID surveillance of approximately 200 basis points as well as a year-over-year headwind from foreign exchange rates. We expect quarterly revenue to ramp sequentially through 2023 with linearity trends similar to what we saw in 2017 when we launched the NovaSeq 6000. GRAIL is expected to deliver revenue in the range of $90 million to $110 million for 2023, reflecting year-over-year growth of 82% at the midpoint, driven by accelerating adoption of the Galleri test.

    現在轉到 2023 年指南。我們預計全年綜合收入將增長 7% 至 10%,達到約 49 億美元至 50.3 億美元。我們預計 2023 年全年核心 Illumina 收入將增長 6% 至 9%,達到約 48.3 億美元至 49.6 億美元。這些範圍包括來自 COVID 監測的預期逆風約 200 個基點,以及來自外匯匯率的同比逆風。我們預計到 2023 年季度收入將按順序增加,其線性趨勢類似於我們在 2017 年推出 NovaSeq 6000 時看到的情況。預計 GRAIL 到 2023 年的收入將在 9000 萬至 1.1 億美元之間,反映同比在加速採用 Galleri 測試的推動下,中點增長了 82%。

  • For fiscal 2023, at the midpoint of our revenue guidance range, we expect core Illumina sequencing revenue to grow approximately 8% year-over-year. This includes intercompany sales to GRAIL of approximately $35 million, which are eliminated in consolidation. We expect core Illumina sequencing instrument growth of approximately 9% year-over-year, driven by the NovaSeq X upgrade cycle and continued momentum in mid-throughput. We expect core Illumina sequencing consumables growth of approximately 8% year-over-year, primarily driven by the NovaSeq X launch as customers build consumables inventory and ramp utilization as well as continued growth in our mid-throughput consumables due to the growing installed base. This growth will be partially offset by further reduced COVID surveillance revenue.

    對於 2023 財年,在我們收入指導範圍的中點,我們預計核心 Illumina 測序收入將同比增長約 8%。這包括對 GRAIL 的約 3500 萬美元的公司間銷售額,這些銷售額在合併中被抵銷。在 NovaSeq X 升級週期和中等通量持續增長的推動下,我們預計核心 Illumina 測序儀器同比增長約 9%。我們預計核心 Illumina 測序耗材同比增長約 8%,這主要是受 NovaSeq X 推出的推動,因為客戶建立耗材庫存和提高利用率,以及由於安裝基礎不斷增長,我們的中等通量耗材持續增長。這一增長將部分被 COVID 監測收入的進一步減少所抵消。

  • We expect annual pull-through for NovaSeq 6000 of approximately $900,000 to $1 million per system in 2023 as customers transition to NovaSeq X. We expect pull-through for NextSeq 1000/2000 in the range of $120,000 to $170,000 per system in 2023 as the record instrument placements in '22 and continued strong placements in 2023 are brought fully online. We expect the remainder of our pull-through ranges to be in line with historical guidance.

    隨著客戶過渡到 NovaSeq X,我們預計到 2023 年每個系統 NovaSeq 6000 的年收入約為 900,000 美元至 100 萬美元。我們預計 NextSeq 1000/2000 的收入將在 2023 年達到每個系統 120,000 美元至 170,000 美元的記錄22 年的樂器放置和 2023 年持續強勁的放置完全在線。我們預計剩餘的突破區間將與歷史指引一致。

  • We also expect revenue from COVID surveillance of approximately $30 million in 2023, which reflects a year-over-year headwind of $105 million or approximately 2 percentage points. We expect consolidated non-GAAP operating margin of approximately 8% in core Illumina non-GAAP operating margin of approximately 22% for 2023. These margins reflect: one, an increase in core Illumina operating expenses from 2022, primarily driven by normalization of our performance-based compensation; two, a temporary decrease in gross margins as we launch NovaSeq X, consistent with what we saw in 2017 when we launched NovaSeq 6000; and three, an increase in GRAIL operating expenses due to the ongoing investments to support the FDA application, NHS trial and to continue to scale GRAIL's commercial organization.

    我們還預計 2023 年來自 COVID 監測的收入約為 3000 萬美元,這反映出同比逆風 1.05 億美元或約 2 個百分點。我們預計 2023 年核心 Illumina 非 GAAP 營業利潤率約為 22% 的合併非 GAAP 營業利潤率約為 8%。這些利潤率反映:一是核心 Illumina 營業費用從 2022 年開始增加,這主要是由於我們的業績正常化基於補償;第二,隨著我們推出 NovaSeq X,毛利率暫時下降,這與我們在 2017 年推出 NovaSeq 6000 時看到的情況一致;第三,由於持續投資以支持 FDA 申請、NHS 試驗和繼續擴大 GRAIL 的商業組織,導致 GRAIL 運營費用增加。

  • We also expect a consolidated non-GAAP tax rate of approximately 36%, which includes an approximately $75 million impact from the R&D capitalization requirements. If these requirements are repealed in 2023, we expect our 2023 non-GAAP tax rate to be approximately 15%. We expect consolidated non-GAAP earnings per diluted share in the range of $1.25 to $1.50, which includes dilution from GRAIL's non-GAAP operating loss of approximately $670 million. And finally, we expect non-GAAP diluted shares outstanding for fiscal 2023 to be approximately 160 million shares.

    我們還預計綜合非 GAAP 稅率約為 36%,其中包括來自研發資本化要求的約 7500 萬美元的影響。如果這些要求在 2023 年被廢除,我們預計 2023 年的非 GAAP 稅率約為 15%。我們預計綜合非 GAAP 每股攤薄收益在 1.25 美元至 1.50 美元之間,其中包括 GRAIL 約 6.7 億美元的非 GAAP 經營虧損的攤薄收益。最後,我們預計 2023 財年的非 GAAP 稀釋流通股約為 1.6 億股。

  • For the first quarter of 2023, we expect consolidated revenue in the range of $1.05 billion to $1.07 billion for Q1 2023, reflecting a sequential decrease of 212 basis points from Q4 2022 at the midpoint, primarily driven by: historical seasonality of our core business due to year-end budget flushes not repeating in the first quarter; partially offset by an increase in high-throughput instrument shipments due to the launch of NovaSeq X in Q1; and a decrease in GRAIL revenue of approximately $5 million due to a milestone payment in Q4 2022.

    對於 2023 年第一季度,我們預計 2023 年第一季度的綜合收入將在 10.5 億美元至 10.7 億美元之間,反映出從中點來看比 2022 年第四季度連續下降 212 個基點,主要受以下因素驅動:我們核心業務的歷史季節性年終預算沖洗不會在第一季度重複;部分被第一季度推出 NovaSeq X 導致的高通量儀器出貨量增加所抵消;由於 2022 年第四季度的里程碑付款,GRAIL 收入減少了約 500 萬美元。

  • We expect quarterly revenue to grow sequentially through 2023, driven by a ramp in NovaSeq X shipments and utilization, recovery from COVID disruptions in China, accelerating adoption of Galleri and an expected mitigation of macroeconomic headwinds in the second half of 2023. For the first quarter, we expect consolidated non-GAAP operating margin of approximately 1% and core Illumina non-GAAP operating margin of approximately 17%. We expect operating margins to improve throughout 2023 as revenue ramps and we scale our production of NovaSeq X and leverage the fixed cost of the manufacturing base.

    我們預計到 2023 年季度收入將連續增長,這得益於 NovaSeq X 出貨量和利用率的上升、中國從 COVID 中斷中恢復、Galleri 的加速採用以及 2023 年下半年宏觀經濟逆風的預期緩解。對於第一季度,我們預計綜合非 GAAP 營業利潤率約為 1%,核心 Illumina 非 GAAP 營業利潤率約為 17%。我們預計隨著收入的增加以及我們擴大 NovaSeq X 的生產並利用製造基地的固定成本,營業利潤率將在整個 2023 年有所提高。

  • We expect net other expense of approximately $9 million, primarily due to the interest expense on our new bond issuances. Lastly, we expect non-GAAP diluted shares outstanding of approximately 160 million shares, in line with fiscal 2023.

    我們預計淨其他費用約為 900 萬美元,主要是由於我們發行新債券的利息費用。最後,我們預計非 GAAP 稀釋流通股約為 1.6 億股,與 2023 財年一致。

  • I'll now hand the call back over to Francis for his final remarks.

    我現在將電話轉回給弗朗西斯,聽取他的最後發言。

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • Thanks, Joydeep. Illumina continues to prioritize innovation. We know our customers invest in our road map, not just our instruments. I talked about the NovaSeq X series earlier. The X is a powerful catalyst for 2023 and beyond. We also prioritized sustainability. NovaSeq X features a 90% reduction in packaging waste and weight and a 50% reduction in plastic usage compared to the NovaSeq 6000. The enablement of ambient temperature shipping of reagents will result in nearly 500 tons of dry ice savings per year while significantly reducing waste streams for our customers. These improvements are game changers for our industry.

    謝謝,喬迪普。 Illumina 繼續將創新放在首位。我們知道我們的客戶投資於我們的路線圖,而不僅僅是我們的儀器。我之前談到了 NovaSeq X 系列。 X 是 2023 年及以後的強大催化劑。我們還優先考慮可持續性。與 NovaSeq 6000 相比,NovaSeq X 的包裝浪費和重量減少了 90%,塑料使用量減少了 50%。啟用試劑的環境溫度運輸每年將節省近 500 噸乾冰,同時顯著減少浪費流為我們的客戶。這些改進改變了我們行業的遊戲規則。

  • We're also excited to bring long-read capabilities to market through 2 upcoming products in our Illumina Complete Long-Reads offering. Our long-read human whole genome assay will be available in the first half of this year, while the enrichment panel will be available in the second half of this year. We recently announced that our enrichment panel will enable a comprehensive, high-accuracy, long-read view for as low as $600 per genome. More than a dozen customers have evaluated data from their own samples using Illumina Complete Long-Reads and their feedback has been strongly positive.

    我們也很高興通過 Illumina Complete Long-Reads 產品中的 2 款即將推出的產品將長讀長功能推向市場。我們的 long-read 人類全基因組分析將在今年上半年推出,而富集 panel 將在今年下半年推出。我們最近宣布,我們的富集面板將以低至每個基因組 600 美元的價格提供全面、高精度、長讀長的視圖。十多個客戶使用 Illumina Complete Long-Reads 評估了他們自己樣本的數據,他們的反饋非常積極。

  • They find Illumina complete long-reads more convenient than other long-read technologies and more straightforward with flexible input requirements. They are impressed with the data accuracy, along with the read lengths and phase blocks that can be generated on Illumina sequencers. Illumina Complete Long-Reads and NovaSeq X will continue to evolve the genomics industry.

    他們發現 Illumina complete long-reads 比其他 long-read 技術更方便,並且更直接且具有靈活的輸入要求。他們對數據準確性以及可以在 Illumina 測序儀上生成的讀取長度和相位塊印象深刻。 Illumina Complete Long-Reads 和 NovaSeq X 將繼續推動基因組學行業的發展。

  • This year, we will celebrate Illumina's 25th anniversary. Over this quarter century, Illumina has remained at the forefront of a global genomics movement, and we're even more optimistic about the road ahead. We're honored to be driving a global health transformation with our customers. And together, we will seize the potential of the genome era.

    今年,我們將慶祝 Illumina 成立 25 週年。在這四分之一個世紀裡,Illumina 一直處於全球基因組學運動的前沿,我們對未來的道路更加樂觀。我們很榮幸能與我們的客戶一起推動全球健康轉型。我們將共同抓住基因組時代的潛力。

  • I'll now invite the operator to open up the line for Q&A. Thank you.

    我現在請接線員開通問答專線。謝謝。

  • Operator

    Operator

  • (Operator Instructions) And we'll go ahead and take our first question from Puneet Souda with SVB Securities.

    (操作員說明)我們將繼續與 SVB 證券一起回答 Puneet Souda 的第一個問題。

  • Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

    Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

  • Congrats on the permanent role, Joydeep. So my first question is, at AGBT, we saw that you had 150 orders as of this morning, and that's 10 more than what you had at the start of this year. So I just wanted to clarify sort of the number increase was only 10 versus what are the advanced pipeline prospects. Maybe if you can provide that number. Again, I appreciate that you're providing the full year 300-plus number, but last time, advanced pipeline prospects, I believe, were 200-plus so if you could clarify how much that increased by because the number increase here within a month was somewhat lower than what we had expected.

    祝賀 Joydeep 成為永久角色。所以我的第一個問題是,在 AGBT,我們看到截至今天早上您有 150 個訂單,這比今年年初多了 10 個。所以我只想澄清一下,與先進的管道前景相比,數量增加僅為 10。也許如果你能提供那個號碼。再次感謝您提供全年 300 多個數字,但我相信上次,先進的管道前景是 200 多個,所以如果您能澄清增加了多少,因為這個數字在一個月內增加了比我們預期的要低一些。

  • And then I just wanted to clarify, Francis, on, what are you hearing from customers in those advanced pipeline prospects? What are they looking for at this point? How is -- what are they waiting for in order to convert their interest into orders? Are they looking for validation for customers, data or anything else? That would be super helpful.

    然後我只想澄清一下,弗朗西斯,你從那些高級管道前景的客戶那裡聽到了什麼?此時他們在尋找什麼?如何——他們在等待什麼才能將他們的興趣轉化為訂單?他們是在尋找客戶、數據或其他任何東西的驗證嗎?那將非常有幫助。

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • Sure. Thanks, Puneet. So let me start with the numbers, as you asked. So as we said, the customer demand for the X series has been very strong, exceeding our expectation. And you know that we recently shared, as you pointed out, that we had 340 instruments spoken for, between 140 in preorders and 200 in advanced pipeline. Now this momentum continued over the last few weeks in January, and we're currently at over 155 instruments in preorders and over 250 in advanced pipeline. So you've seen the progression as we work through January.

    當然。謝謝,普尼特。所以讓我按照你的要求從數字開始。所以正如我們所說,客戶對X系列的需求非常旺盛,超出了我們的預期。你知道,正如你所指出的,我們最近分享了 340 種儀器,其中 140 種處於預購狀態,200 種處於高級管道中。現在,這種勢頭在 1 月份的最後幾週持續存在,目前我們有超過 155 種儀器處於預購狀態,超過 250 種處於高級管道中。所以你已經看到了我們在一月份工作的進展。

  • Now going forward, we plan to update you quarterly, as usual, both on how we're doing with orders, but now as we've started shipping, obviously, we'll update you on shipments as well. What we're hearing from customers as we go through the pipeline is that they're incredibly excited about some of the things we expected them to be excited about. So they're excited about the power of the X series in terms of being able to run much -- many more samples concurrently than they could before. They're very excited about the economics associated with running the X.

    現在展望未來,我們計劃像往常一樣每季度向您更新我們如何處理訂單,但現在我們已經開始發貨,顯然,我們也會向您更新發貨情況。當我們通過管道時,我們從客戶那裡聽到的是,他們對我們期望他們興奮的一些事情感到非常興奮。因此,他們對 X 系列的強大功能感到興奮,因為它能夠同時運行比以前更多的樣本。他們對與運行 X 相關的經濟性感到非常興奮。

  • And they're equally excited about the sustainability features that we put into the X, so the reduction in plastic and waste, but also the elimination of the need for dry ice as part of the shipping. All of these combined with the ease of use that they're seeing, so when we describe the specs to them at IGF, they got a sense of the power and the performance and the faster turnaround time. But one of the things that people have been, I think, pleasantly surprised about is they get to interact with the X is the investments we've made around ease of use of the workflow.

    他們對我們在 X 中加入的可持續性特徵同樣感到興奮,因此減少了塑料和廢物,而且還消除了在運輸過程中對乾冰的需求。所有這些與他們所看到的易用性相結合,因此當我們在 IGF 上向他們描述規格時,他們感受到了強大的功能和性能以及更快的周轉時間。但我認為,讓人們驚喜的一件事是他們可以與 X 進行交互,這是我們圍繞工作流程的易用性所做的投資。

  • So this is even a significant step forward than the state-of-the-art with the 6000 before. And what that opens up is the ability for the sequencers to be used by a technical team that is not as -- doesn't necessarily require a degree in genomics, for example. And so that opens up workforce capabilities for them. Now what we're hearing from research customers is, increasingly, they're starting to see the X as a must-have in terms of being able to remain competitive for grants and grant dollars. And so we're starting to see people cost that into thinking about how they will apply for grants.

    因此,這甚至比之前 6000 的最先進技術向前邁出了重要一步。開放的是測序儀被技術團隊使用的能力——例如,不一定需要基因組學學位。因此,這為他們開闢了勞動力能力。現在,我們從研究客戶那裡聽到的是,他們越來越多地開始將 X 視為能夠在贈款和贈款資金方面保持競爭力的必備品。因此,我們開始看到人們在考慮如何申請撥款時會為此付出代價。

  • On the clinical side, what we're hearing is that because of the superior workflow performance and cost associated with the X, clinical customers are designing their new assays and their new tests on the X with the anticipation that, that's how they'll roll out new testing. At the same time, they're starting to want to get familiar with the workflow so that they can plan a transition over on their existing tests. So that will take longer. So the first demand from clinical customers is about new testing that they want to do on the X. So that's some of the feedback we're getting from our customers.

    在臨床方面,我們聽到的是,由於與 X 相關的卓越工作流程性能和成本,臨床客戶正在設計他們在 X 上的新化驗和新測試,並期望這就是他們將如何滾動出新的測試。同時,他們開始想要熟悉工作流程,以便他們可以計劃對現有測試進行過渡。所以這將需要更長的時間。因此,臨床客戶的第一個需求是他們想在 X 上進行的新測試。這就是我們從客戶那裡得到的一些反饋。

  • Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

    Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

  • Yes. And maybe, Puneet -- thank you, first of all, for your kind words there. I think the other question you asked is what are customers waiting to convert from the funnel to the orders, right? And this is, remember, this is late-stage funnel so we have confirmed interest. They like what they see, as Francis mentioned, and they have line of sight to budget, right? So usually, it's the -- when are they going to get the budget? Maybe it's finishing up or confirming some of the grants, which then tips them over into orders. And we fully expect that, as we have seen in other years, to happen as we go through the year.

    是的。也許,Puneet——首先感謝你的客氣話。我認為您問的另一個問題是客戶在等待什麼從渠道轉換為訂單,對吧?請記住,這是後期漏斗,所以我們已經確認了興趣。正如 Francis 提到的,他們喜歡他們所看到的,並且他們有預算的視線,對吧?所以通常,這是——他們什麼時候會得到預算?也許它正在完成或確認一些贈款,然後將它們轉入訂單。我們完全希望,正如我們在其他年份所看到的那樣,在我們度過這一年時會發生。

  • Operator

    Operator

  • And we'll go ahead and move on to our next question from Dan Brennan with Cowen.

    我們將繼續與 Cowen 一起討論 Dan Brennan 的下一個問題。

  • Daniel Gregory Brennan - Senior Tools & Diagnostics Analyst

    Daniel Gregory Brennan - Senior Tools & Diagnostics Analyst

  • Joydeep, congrats. Maybe first on the guidance. I believe at JPMorgan, you guys talked about the '23 guide reflected a conservative approach. I'm just wondering, just given the history in the back half of '22, have you learned anything? Has the process changed in terms of how you're guiding? Could you just walk through a little bit about the conservatism or however you want to quantify it, that's within the '23 guide?

    Joydeep,恭喜。也許首先在指導上。我相信在摩根大通,你們談論的 23 年指南反映了一種保守的方法。我只是想知道,鑑於 22 世紀後半段的歷史,你學到了什麼嗎?就您的指導方式而言,流程是否發生了變化?您能否簡單介紹一下保守主義,或者您想如何量化它,這在 23 年指南中?

  • I know, Francis, you guys quantified a fair number of kind of headwinds. Just wondering how much maybe you baked in cumulatively for those headwinds or however you would kind of discuss the process and the conservatism. And then just, B, just on GRAIL. Would love an update assuming that the EC directive comes back here during Q1. I know you guys are going to apply for a stay, but I'm just -- if you can kind of walk us through the process as you see it. If you don't get a stay, then kind of what happens? And related to that, the GRAIL balance sheet. Just wondering, ultimately, if GRAIL has to be divested, how do we think about the capital that Illumina has to commit to that?

    我知道,弗朗西斯,你們量化了相當多的逆風。只是想知道您可能為這些逆風累積了多少,或者您會討論這個過程和保守主義。然後,B,就在 GRAIL 上。假設 EC 指令在第一季度回到這裡,我會喜歡更新。我知道你們會申請逗留,但我只是——如果你們能像你們看到的那樣引導我們完成整個過程。如果你沒有得到停留,那麼會發生什麼?與此相關的是 GRAIL 資產負債表。只是想知道,如果最終必須剝離 GRAIL,我們如何看待 Illumina 必須為此投入的資金?

  • Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

    Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

  • Yes, Dan. First of all, thank you. So in terms of '23 guidance, we have, as we mentioned earlier, right, pulled in a few things that were visible, of course, is, one, the transition to NovaSeq X. We have mentioned that this is -- demand is going to outstrip supply. And we've also told you about linearity, that we do expect the second half to be -- for revenue to step up in each quarter as the NovaSeq X gets out to market and people start bringing up the instrument and ordering NovaSeq X consumables.

    是的,丹。首先,謝謝你。因此,就 '23 指南而言,正如我們之前提到的那樣,我們已經引入了一些可見的東西,當然,其中之一是向 NovaSeq X 的過渡。我們已經提到這是 - 需求是將供不應求。我們還告訴過您有關線性度的信息,我們確實預計下半年會是——隨著 NovaSeq X 進入市場並且人們開始使用儀器並訂購 NovaSeq X 耗材,每個季度的收入都會增加。

  • We also expect that -- we placed a large number of mid-throughput instruments late in 2022 and continue to expect to place additional NextSeq 1000/2000 instruments in -- throughout '23. So as those come online, right, then you would expect an increase in the consumables ramp up as we get through the year.

    我們還預計——我們將在 2022 年底放置大量中等通量儀器,並繼續期望在整個 23 年放置更多的 NextSeq 1000/2000 儀器。因此,當它們上線時,對,那麼你會期望隨著我們度過這一年,消耗品會增加。

  • Also in 2023, we have talked a little bit about the recovery in China in the second half of the year. So we had seen China going into the end of '22 and then even the first quarter of 2023 with some COVID hangover and rollover from last year. So right now, we believe that those should abate. And we also have a lower impact of FX from first half from -- obviously, from first half into second half of the year. So for all those reasons, we do expect, even after taking into account some of the slowdown in recruitment that we have seen in large pop-gen projects, that we will see linearity and revenue step up throughout 2023. And I'll hand it over to Francis for the second part of the question.

    同樣在2023年,我們已經談到了下半年中國的複蘇。因此,我們看到中國進入 22 年底,然後甚至是 2023 年第一季度,從去年開始有一些 COVID 宿醉和延期。所以現在,我們認為這些應該減少。而且從上半年到下半年,我們對外彙的影響也較小 - 顯然,從上半年到下半年。因此,出於所有這些原因,我們確實預計,即使考慮到我們在大型流行一代項目中看到的一些招聘放緩,我們仍會在整個 2023 年看到線性和收入增加。我會把它交給問題的第二部分交給弗朗西斯。

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • Sure. So Dan, in terms of the GRAIL process, we are expecting the divestiture order to come out at the end of Q1, so maybe beginning of Q2. And we are going to apply, if there isn't a stay associated with it pending the appeals, we're going to ask for one. And then we're going to pursue the dual track and we'd be pragmatic as we go down both paths. On the 1 hand, we're going to have a divestiture track where we work with the European Commission GRAIL and go down the path to -- on the divestiture sort of process. And we expect that to play out over the course of this year going into next year.

    當然。所以 Dan,就 GRAIL 流程而言,我們預計剝離訂單將在第一季度末發布,所以可能會在第二季度初發布。我們將申請,如果在等待上訴期間沒有與之相關的中止,我們將要求中止。然後我們將追求雙軌,我們將在兩條道路上走下去時務實。一方面,我們將有一個資產剝離軌道,我們與歐盟委員會 GRAIL 合作,並沿著資產剝離的過程走下去。我們預計這將在今年到明年的過程中發揮作用。

  • And in parallel, we have our appeals, and we have 2 appeals underway. One is around the jurisdiction, and we expect a decision probably towards the end of this year and another one is on the prohibition order, and we expect a decision maybe towards the end of this year, maybe sometime into next year. And so those are the 2 paths.

    同時,我們有我們的上訴,我們有 2 個上訴正在進行中。一個是關於管轄權的,我們預計可能會在今年年底做出決定,另一個是關於禁令的決定,我們預計可能會在今年年底做出決定,可能會在明年的某個時候做出決定。這就是兩條路徑。

  • In terms of the capitalization, part of the divestiture track is going to be around making sure that GRAIL is capitalized going forward. And that could be through a combination of strategic partners that invest in GRAIL. That could be a path. It could be a multistep path that includes initially investment into GRAIL from strategic partners heading towards an IPO. But all of that is dependent on what comes out in the divestiture order, and that's something we're still in conversations with. So we'll keep you updated as that makes progress.

    在資本化方面,資產剝離的一部分將圍繞確保 GRAIL 未來的資本化。這可以通過投資 GRAIL 的戰略合作夥伴的組合來實現。那可能是一條路。這可能是一個多步驟的路徑,包括從戰略合作夥伴開始對 GRAIL 進行首次公開募股的投資。但所有這些都取決於資產剝離令中的內容,而這正是我們仍在討論的內容。因此,我們會在取得進展時及時通知您。

  • Operator

    Operator

  • Our next question comes from Dan Arias with Stifel.

    我們的下一個問題來自 Stifel 的 Dan Arias。

  • Daniel Anthony Arias - MD & Senior Analyst

    Daniel Anthony Arias - MD & Senior Analyst

  • I wanted to touch on GRAIL, too, if I may. Joydeep, on the dilution for 2023, the $670 million, I'm just curious how much flexibility you have to work with in that number and the investment associated with that number. Just with the point being that, obviously, the forecast for Galleri is tough to call at this stage in the game. So to the extent that the revenue picture were to start to look different down the road, I'm wondering just how much of what you might have to spend there might be variable in one way or another.

    如果可以的話,我也想談談 GRAIL。 Joydeep,關於 2023 年的稀釋,即 6.7 億美元,我只是想知道你在這個數字上有多大的靈活性以及與這個數字相關的投資。關鍵是,很明顯,在比賽的這個階段很難預測加萊里的表現。因此,就收入情況在未來開始看起來不同的程度而言,我想知道你可能需要花費多少可能會以某種方式發生變化。

  • And then Francis, on the GRAIL NHS project and part 1 of that study, the 140,000 asymptomatic population assessment. The documents from the NHS, if I remember correctly, stated that the initial results were expected to be available in late 2023. Is that still the time line we should be thinking about? I mean I'm just -- I'm thinking about your comment on potential IPO and just outcomes there and what might be important to that process.

    然後是弗朗西斯,關於 GRAIL NHS 項目和該研究的第 1 部分,即對 140,000 名無症狀人群的評估。如果我沒記錯的話,來自 NHS 的文件指出,初步結果預計將在 2023 年底公佈。這仍然是我們應該考慮的時間線嗎?我的意思是我只是 - 我正在考慮您對潛在 IPO 的評論以及那裡的結果以及對該過程可能重要的內容。

  • Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

    Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

  • All right. Dan, thanks for the question. So in terms of the GRAIL dilution of about $670 million this year, right, a couple of points there. So a lot of that is going towards continuing to accelerate some of the clinical trials in advance of completion of the NHS trials, the submission to the FDA for the Galleri products and, of course, to ramp up the sales and marketing that is required as the product continues its successful commercial launch, right? They've had a really successful commercial launch.

    好的。丹,謝謝你的提問。因此,就今年約 6.7 億美元的 GRAIL 稀釋而言,有幾點。因此,其中很大一部分將用於在 NHS 試驗完成之前繼續加速一些臨床試驗,向 FDA 提交 Galleri 產品,當然,還要增加所需的銷售和營銷該產品繼續其成功的商業發布,對吧?他們的商業發布非常成功。

  • The way we have projected revenues into next year and based on -- it's really based on the run rate that we have seen with Galleri as they have exited 2022 and some of what they had in the funnel into 2023 and certain assumptions of repeat testing around that. So given that, I will point out, and again, I will say that GRAIL is held separate, so Illumina and Francis and I don't really control their -- how they spend their money and how they operate the company.

    我們預測明年收入的方式和基於——它實際上是基於我們在 Galleri 看到的運行率,因為他們已經退出 2022 年,他們在進入 2023 年的漏斗中有一些東西,以及圍繞重複測試的某些假設那。因此,考慮到這一點,我會再次指出,我會說 GRAIL 是分開的,所以 Illumina 和 Francis 和我並沒有真正控制他們——他們如何花錢以及他們如何運營公司。

  • But I will point out that in 2022, they have been very good with how they've managed to adjust operating expenses as revenues have been different from what their -- some of their original expectations were. So we have faith in GRAIL's management that they are -- they're good managers, they're good with how they allocate their money into the right places that really prioritize the clinical trials and the commercialization of the product.

    但我要指出的是,到 2022 年,他們在調整運營支出方面做得非常好,因為收入與他們最初的一些預期不同。因此,我們對 GRAIL 的管理充滿信心——他們是優秀的管理者,他們善於將資金分配到真正優先考慮臨床試驗和產品商業化的正確地方。

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • And then, Dan, I'll respond about the NHS contracts. As you pointed out, the GRAIL team has a contract with the NHS that covers the 140,000-person clinical trial that is underway, but also covers the next phase pending performance of the trial. And so they've already got an agreement with the NHS that if the trial meets its performance criteria, that the NHS will roll this test out to 1 million participants in the U.K. over 2024 and 2025, and that will be paid for by the NHS. The time frame for that readout is the end of this year, maybe the beginning of next year. So it's still the time frame that was contemplated in the contract.

    然後,丹,我會回應有關 NHS 合同的問題。正如您所指出的,GRAIL 團隊與 NHS 簽訂了一份合同,涵蓋正在進行的 140,000 人臨床試驗,但也涵蓋下一階段待執行的試驗。因此,他們已經與 NHS 達成協議,如果試驗符合其績效標準,NHS 將在 2024 年和 2025 年向英國的 100 萬參與者推廣這項測試,並將由 NHS 支付費用.該讀數的時間範圍是今年年底,也許是明年年初。所以它仍然是合同中考慮的時間範圍。

  • Operator

    Operator

  • And we'll move on to our next question with Vijay Kumar with Evercore ISI.

    我們將繼續與 Evercore ISI 的 Vijay Kumar 討論下一個問題。

  • Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team

    Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team

  • I had a 3-part question here. Francis, one on revenues. If you look at Q1, I think the implied guidance, teens declines. So I think the back half implied is north of 20% year-on-year revenue growth to hit the high singles to low doubles for the annual. What gives you that back half ramp here when I look at this on a year-on-year basis? I know you mentioned the historical launch year as a comp. But can you just walk us through on the visibility you have on those numbers?

    我在這裡有一個由三部分組成的問題。弗朗西斯,一個關於收入。如果你看第一季度,我認為隱含的指導,青少年下降。因此,我認為後半部分意味著超過 20% 的同比收入增長將達到年度高單低雙。當我逐年查看時,是什麼讓您在這里後退一半?我知道您提到過歷史性的發布年份作為補償。但是你能告訴我們你對這些數字的可見性嗎?

  • And Joydeep, one on margins here for you. Why did gross margin decline sequentially Q-on-Q when I look at Q4 versus Q3? And if you start in Q1 at 17% op margins for core Illumina, is the implied exit rate for core Illumina in the high 20s when we look at Q4 '23?

    還有 Joydeep,這里為您準備了一個利潤率。當我查看第四季度與第三季度時,為什麼毛利率連續下降?如果您在第一季度以核心 Illumina 的 17% 運營利潤率開始,那麼當我們查看 23 年第四季度時,核心 Illumina 的隱含退出率是否在 20 多歲?

  • Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

    Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

  • Listen, let me start and I'll give you some piece in terms of back half ramp on revenues, right? So let me start with the first half -- the first quarter and first half, right? We had very strong quarters in 2021 for the first half. We had record shipments of NovaSeq 6000s, if you remember, at the beginning of the year, still ramping COVID surveillance revenues. So this year, because in Q1, we are -- we've said we're going to ship about 40 to 50 NovaSeq Xs, which is far short of what our demand is for that.

    聽著,讓我開始吧,我會給你一些關於收入後半段斜坡的部分,對吧?那麼讓我從上半場開始——第一節和上半場,對吧? 2021 年上半年我們的季度表現非常強勁。如果您還記得的話,我們的 NovaSeq 6000 出貨量創歷史新高,在今年年初,COVID 監測收入仍在增加。所以今年,因為在第一季度,我們 - 我們已經說過我們將運送大約 40 到 50 個 NovaSeq Xs,這遠遠低於我們對此的需求。

  • You would expect that the first half of the year, growth rates are constrained as we ramp up NovaSeq X and we ramp up consumables purchases related to that. In the second half of the year, the story kind of flips a little bit, right? So you have much more kind of full -- approaching full throttle of NovaSeq X shipments. You have the incremental benefit of people bringing on NovaSeq X consumables. You also have some of the effects, which were headwinds this year, in terms of China COVID, in terms of overall COVID surveillance going down in the back half of the year. So you're right, the percentage growth rates in the latter part of the year and the actual revenue both start to step up in the second part of the year. So hopefully, that part is clear.

    你會預計今年上半年,隨著我們增加 NovaSeq X 以及增加與之相關的耗材採購,增長率將受到限制。下半年,故事有點翻轉,對吧?所以你有更多的全 - 接近 NovaSeq X 出貨量的全速。人們使用 NovaSeq X 耗材會讓您受益匪淺。就中國 COVID 而言,就今年下半年整體 COVID 監測下降而言,你也有一些影響,這是今年的不利因素。所以你是對的,今年下半年的百分比增長率和實際收入都在今年下半年開始上升。所以希望那部分是清楚的。

  • In terms of margins, so let me talk about gross margin first. Gross margin declines quarter-over-quarter and, of course, this being a launch year, primarily due to the impact of -- especially if you look at quarter-on-quarter, is really due to the impact of launching NovaSeq X in Q1, which, as we had told you, would start off this year with a lower margin. We expect that margin to continue to improve as we go into the latter part of 2023, as we have much more utilization of the factories and, of course, we start squeezing out efficiencies in the process, as is normal.

    在利潤率方面,讓我先談談毛利率。毛利率環比下降,當然,今年是發布年,主要是由於影響——尤其是環比來看,實際上是由於第一季度推出 NovaSeq X 的影響,正如我們告訴過你的那樣,今年開始時利潤率會降低。我們預計,隨著我們進入 2023 年下半年,利潤率將繼續提高,因為我們對工廠的利用率要高得多,當然,我們開始像往常一樣壓榨流程中的效率。

  • And I think the same thing with operating margin. I think your question there was, you start off with a fairly low operating margin. For us, it's -- as both gross margin and the revenue profile improves, operating margin should improve as we go into the second half of the year. And that's mostly just math in terms of much better revenue profile to cover operating expense, which remains relatively flat as we go through the year. So hopefully, that helps you understand a little bit of how we've thought through the year.

    我認為營業利潤率也是如此。我想你的問題是,你從一個相當低的營業利潤率開始。對我們來說,隨著毛利率和收入狀況的改善,隨著我們進入今年下半年,營業利潤率應該會提高。就更好的收入狀況來支付運營費用而言,這主要只是數學,在我們經歷這一年時,運營費用仍然相對持平。希望這可以幫助您了解我們這一年的想法。

  • Operator

    Operator

  • And our next question comes from Tejas Savant with Morgan Stanley.

    我們的下一個問題來自摩根士丹利的 Tejas Savant。

  • Tejas Rajeev Savant - Equity Analyst

    Tejas Rajeev Savant - Equity Analyst

  • So 2-parters here. First on GRAIL, Francis, just going back to Dan's question there. Can you talk a little bit about how much of that $670 million in OpEx this year is specifically related to that NHS clinical trial that presumably drops out starting in '24? And is there the possibility of a delay or a period of evaluation as the results come in from that before that 1 million paid pilot launches?

    所以這裡有 2 個夥伴。首先是關於 GRAIL,Francis,回到 Dan 的問題。你能談談今年 6.7 億美元的 OpEx 中有多少與可能從 24 年開始退出的 NHS 臨床試驗特別相關嗎?在 100 萬付費試點啟動之前得出結果時,是否有可能延遲或評估一段時間?

  • And then second on NovaSeq X pull-through assumptions, if I look back to the 6000 launch, you guys were approaching almost 1 million in pull-through about 6 quarters into the launch. So is there any reason why you couldn't sort of easily exceed that, say, 6 quarters into the X launch or the back half of '24, should that number be sort of 1.3 million, 1.4 million-plus. Is that fair?

    然後是關於 NovaSeq X pull-through 假設,如果我回顧 6000 次發布,你們在發布後大約 6 個季度的 pull-through 接近近 100 萬。那麼,如果這個數字是 130 萬、140 萬以上,那麼有什麼理由不能輕易超過這個數字,比如 X 發布後的 6 個季度或 24 年的後半部分。這公平嗎?

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • So thanks for the question, Tejas. Let me take some, and then Joydeep will chime in if he has anything to add. So let me start with the GRAIL question and around how much of that $670 million is associated with the NHS trial and is there a chance that the readout is delayed or the next phase is delayed. So a portion of it is, so we haven't actually broken out that $670 million. A portion of it is, but it's not the majority of it. So there are a number of things going on at GRAIL. In addition to the NHS trial, there is also the studies they're doing for the FDA submission, and they are looking to have the final submission done towards the end of next year. And so they're sort of in the thick of things with the FDA.

    謝謝你的問題,Tejas。讓我拿一些,如果 Joydeep 有什麼要補充的,他會插話。因此,讓我從 GRAIL 問題開始,圍繞這 6.7 億美元中有多少與 NHS 試驗相關,以及是否有可能延遲讀出或延遲下一階段。所以其中一部分是,所以我們實際上還沒有突破那 6.7 億美元。有一部分是,但不是大部分。所以在 GRAIL 上發生了很多事情。除了 NHS 試驗外,還有他們正在為 FDA 提交所做的研究,他們希望在明年年底完成最終提交。因此,他們在某種程度上與 FDA 有密切關係。

  • However, there is the part associated with that NHS trial. And as you point out, that moves from being a pure cost to GRAIL right now for this 140,000-person trial to next year being a paid rollout, starting next year over 2 years to 1 million people. So a pretty significant shift in economics positively for GRAIL next year.

    但是,有與該 NHS 試驗相關的部分。正如你所指出的,這從現在的 140,000 人試驗的 GRAIL 純成本轉變為明年的付費推出,從明年開始超過 2 年達到 100 萬人。因此,明年對 GRAIL 來說,經濟上的一個非常重大的轉變是積極的。

  • In terms of the time frame, the NHS did a very thorough sort of diligent job with GRAIL in terms of planning out this trial. And because GRAIL has done so many studies of such significant size before, they really had a good handle on how to analyze the data coming in and sort of what you would need to get to get to the decision that they're looking for. And so we don't expect and we haven't seen at this point any delays associated with the analysis that's happening of the data. And so we fully expect them to be getting to that readout at the end of this year, beginning of next year.

    就時間框架而言,NHS 在規劃本次試驗方面對 GRAIL 進行了非常徹底的勤奮工作。而且因為 GRAIL 之前做過很多如此大規模的研究,所以他們確實很好地掌握瞭如何分析進來的數據,以及你需要得到什麼才能做出他們正在尋找的決定。因此,我們不期望並且我們目前還沒有看到與正在發生的數據分析相關的任何延遲。因此,我們完全希望他們能夠在今年年底、明年年初獲得該讀數。

  • And then similarly, because of the power of this test and the NHS being so keen to really use this test as a core component in their war on cancer, their intent is to get through the readout as responsibly and quickly as possible. And once the demonstrated meets the performance criteria, to get to that rollout as quickly as possible. And so there's a huge motivation on the side of the NHS again because of the potential life-saving benefits of this test. And obviously, there's motivation on the GRAIL side, too. And so I don't expect there to be any delays that pop up between the readout and then rolling out the test.

    同樣,由於這項測試的強大功能,以及 NHS 如此熱衷於真正將這項測試作為他們抗癌戰爭的核心組成部分,他們的意圖是盡可能負責任地快速完成讀數。一旦演示滿足性能標準,就盡快推出。因此,由於這項測試可能挽救生命,NHS 再次獲得了巨大的動力。顯然,GRAIL 方面也有動力。因此,我不希望在讀數和推出測試之間出現任何延遲。

  • In terms of the 6000 pull-through then, what we have said, and you've seen this before, is really we expect some time likely between the first and second year for us to get to a stable point in terms of pull-through. And you pointed that out that we got there on the 6000 in that kind of time frame. And so one, we do expect that to be the time frame and we'll keep you updated as we work through the process. And as you know, but for everyone else, before that, the numbers are still too volatile for it to be a useful modeling metric because as you put out a whole bunch of new instruments and people start to ramp up, the pull-through can move pretty significantly from 1 week to the next, 1 quarter to the next.

    就 6000 點突破而言,我們已經說過,你之前已經看到了,我們真的希望在第一年和第二年之間有一段時間,以便我們在突破方面達到穩定點.你指出我們在那種時間框架內到達了 6000。因此,我們確實希望這是一個時間框架,我們會在整個過程中為您提供最新信息。正如你所知,但對於其他人來說,在此之前,數字仍然波動太大,無法成為有用的建模指標,因為當你推出一大堆新工具並且人們開始增加時,拉動可以從 1 周到下一周,從 1 個季度到下一個季度,變化非常顯著。

  • And so it takes that year for you to get enough instruments out there for the number to be significant. Now also, as you pointed out, as we get to a stable number for the X, we feel really confident that the ultimate pull-through number on the X will be comfortably above what we had with the 6000 because of the power of the X and the quick turnaround time and the ability to run just so much more on an X over a year.

    因此,您需要在那一年獲得足夠的儀器,才能使數量變得可觀。現在,正如您所指出的,當我們獲得 X 的穩定數字時,我們非常有信心,由於 X 的強大功能,X 的最終直通數字將輕鬆高於我們在 6000 上的數字以及快速的周轉時間和一年內在 X 上運行更多的能力。

  • Operator

    Operator

  • And we'll go ahead and move on to our next question with Sung Ji Nam with Scotiabank.

    我們將繼續與 Scotiabank 的 Sung Ji Nam 一起討論下一個問題。

  • Sung Ji Nam - Analyst

    Sung Ji Nam - Analyst

  • Another one on GRAIL. Would love to get your thoughts, Francis, in terms of you talked about the FDA Breakthrough Designation for the Galleri test kind of -- I know -- but it's still kind of an uncharted territory to get it going through the FDA process and also maybe gaining broader reimbursement from Medicare. So could you kind of talk about kind of what efforts are being made in order to move forward with those -- in that direction?

    GRAIL 上的另一個。很想听聽你的想法,弗朗西斯,你談到了 FDA 對 Galleri 測試的突破性指定——我知道——但它仍然是一個未知的領域,讓它通過 FDA 流程,也許從 Medicare 獲得更廣泛的報銷。那麼,您能否談談正在做出哪些努力,以便朝著那個方向前進?

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • Yes, sure. So let me talk about a few things. One, as you pointed out, GRAIL has been able to get Breakthrough Designation from the FDA. And they have been working now with the FDA for a number of years on designing the studies that will be part of the ultimate submission. And so they've been working collaboratively with the FDA. And although they've been working with them, they've already submitted some of the modules associated with the FDA submission, and they are planning to do the final module submission at the end of next year, maybe extending into the beginning of the year after. So they're making good progress.

    是的,當然。那麼讓我談談一些事情。第一,正如您所指出的,GRAIL 已經能夠從 FDA 獲得突破性指定。他們現在已經與 FDA 合作多年,設計將成為最終提交的一部分的研究。因此,他們一直在與 FDA 合作。儘管他們一直在與他們合作,但他們已經提交了一些與 FDA 提交相關的模塊,他們計劃在明年年底提交最終模塊,可能會延長到今年年初後。所以他們正在取得良好的進展。

  • The other big step with the FDA, which really breaks new ground, is that they've been talking to the FDA about submitting data from the NHS trial as part of the FDA submission. Now that's really powerful because that's a very large trial. And so that continues to add to the bolus of evidence that GRAIL was able to get and submit into the FDA. And so I think it's -- we're starting to see the benefits of that good working relationship between GRAIL and the FDA.

    FDA 的另一大舉措,真正開闢了新天地,是他們一直在與 FDA 討論將 NHS 試驗的數據作為 FDA 提交的一部分。現在這真的很強大,因為這是一個非常大的試驗。因此,這繼續增加了 GRAIL 能夠獲得併提交給 FDA 的大量證據。所以我認為——我們開始看到 GRAIL 和 FDA 之間良好工作關係的好處。

  • And as you know, when you have the FDA approval, that's a pretty significant step forward in terms of getting broad reimbursement in the United States, which is a really, really big value creation point from a GRAIL perspective. So you'll see both things play out in the next couple of years. You'll see the big NHS move from going from a trial to a rollout, a population rollout, starting with the 1 million people and then going population-wide after the 1 million people rollout in the first 2 years. And at the same time, you'll see the progress in the U.S. with the final FDA submission at the end of next year and then the path towards broad reimbursement in the U.S.

    正如你所知,當你獲得 FDA 批准時,這是在美國獲得廣泛報銷方面向前邁出的非常重要的一步,從 GRAIL 的角度來看,這是一個非常非常大的價值創造點。所以你會看到在接下來的幾年裡這兩件事都會發生。你會看到大型 NHS 從試驗到推廣,人口推廣,從 100 萬人開始,然後在前 2 年的 100 萬人推廣之後走向全民。與此同時,你會看到美國在明年年底最終提交 FDA 的進展,然後是在美國實現廣泛報銷的道路。

  • Operator

    Operator

  • We'll go ahead and hear from David Westenberg with Piper Sandler.

    我們將繼續聽聽 David Westenberg 和 Piper Sandler 的講話。

  • David Michael Westenberg - MD & Senior Research Analyst

    David Michael Westenberg - MD & Senior Research Analyst

  • Congrats again to Joydeep. So 2 I'll just ask upfront. Many of the lab companies that we cover are talking about reduced cash burn, and they're really excited about NovaSeq X and how even some of them are kind of excited about going from NovaSeq from NextSeq. So can you help us reconcile their desire to reduce cash burn and your expectation of increased spend with you?

    再次恭喜 Joydeep。所以 2 我會提前詢問。我們報導的許多實驗室公司都在談論減少現金消耗,他們對 NovaSeq X 感到非常興奮,甚至其中一些公司對從 NovaSeq 轉向 NextSeq 感到有點興奮。那麼你能幫助我們調和他們減少現金消耗的願望和你對增加支出的期望嗎?

  • And then just my second one is just continuing on some of the price stuff. Why should we not be concerned about the new $99 Complete Genome -- Complete Genomics thing today?

    然後我的第二個只是繼續一些價格問題。為什麼我們今天不應該關心新的 99 美元的完整基因組——完整基因組學?

  • Francis A. deSouza - CEO & Director

    Francis A. deSouza - CEO & Director

  • Thank you for the question, Dave, so let me go through them in order. So first, we're hearing just like you're hearing from lab companies that are really excited about the -- again, it's the power, the performance, the turnaround time, but also the economics associated with the X. And I talked about the fact that increasingly, people are going to see those economics as table stakes for applying for and winning new grants.

    戴夫,謝謝你提出這個問題,所以讓我按順序講一遍。所以首先,我們聽到的就像您從實驗室公司那裡聽到的一樣,他們對 X 的功能、性能、周轉時間以及與 X 相關的經濟性感到非常興奮。我談到了事實上,人們越來越多地將這些經濟學視為申請和贏得新贈款的籌碼。

  • But for lab companies, too, especially in this environment, as they are looking to squeeze the most out of their operations, they see the X as a path to get there, and the superior economics will help them as they lower cash burn and reduce their capital needs going forward. And so we fully expect that to be part of the conversation with our customers.

    但對於實驗室公司來說也是如此,尤其是在這種環境下,因為他們希望從運營中獲得最大收益,他們將 X 視為實現目標的途徑,卓越的經濟效益將幫助他們降低現金消耗並減少他們的資金需要向前發展。因此,我們完全希望這成為與客戶對話的一部分。

  • Similarly, we're seeing that on the NextSeq side, right? So we're seeing customers that are seeing more demand come in. And the question for them is do they buy the next NextSeq or do they fundamentally transform their cost structure and move to the X? And that's part of the reason why we're seeing a higher-than-expected demand from 2 segments: one, from the clinical segment, and we talked about the preorders coming in represent a higher percentage of clinical customers than we expected; and two, from new to Illumina and new to high-throughput customers. And so that dynamic is already showing up in the preorder number.

    同樣,我們在 NextSeq 方面看到了這一點,對吧?所以我們看到客戶的需求越來越多。他們的問題是他們是購買下一個 NextSeq 還是從根本上改變他們的成本結構並轉向 X?這就是為什麼我們看到兩個部分的需求高於預期的部分原因:一個是臨床部分,我們談到預購代表臨床客戶的比例高於我們的預期;另一個是臨床部分。第二,從新客戶到 Illumina 客戶和新客戶到高通量客戶。因此,這種動態已經出現在預訂單號中。

  • In terms of the competitive dynamics. One of the things that we're really excited about is that when we talk to customers, they get very quickly that when they're comparing what system to buy, they really look at -- they need to look at the total cost of ownership in terms of running these sequencers. And that's one of the unique things about the Illumina portfolio around that, started with the NextSeq 1000/2000 but now with the NovaSeq X, is that we have built in capabilities like the compute associated with the primary, secondary and, in some cases, even parts of the tertiary pipelines that are baked into and built into the instrument, that we've built into the instrument capabilities like lossless data compression.

    在競爭動態方面。我們真正感到興奮的一件事是,當我們與客戶交談時,他們很快就會知道,當他們比較要購買的系統時,他們真正關注的是——他們需要查看總擁有成本在運行這些音序器方面。這是 Illumina 產品組合的獨特之處之一,從 NextSeq 1000/2000 開始,但現在有了 NovaSeq X,我們已經內置了與主要、次要相關的計算等功能,在某些情況下,甚至是內置於儀器中的三級管道的一部分,我們已經將其內置到儀器功能中,例如無損數據壓縮。

  • And so when they start to compare prices, it's not just the cost of sequencing that they need to look at but it's also the associated compute costs, the storage costs that they would need if they had any other sequencer in the market. And one of the things that I talked about when we talk about the X is that just the compute savings you get associated with the NovaSeq X will save you over $1 million over a 4-, 5-year period. And so that's really exciting for them. Forget about the real estate requirements, forget about the time it would take to post process your data. All of those are important, but they also see that the total cost of ownership of the X is so much superior because of those built-in capabilities.

    因此,當他們開始比較價格時,他們不僅需要考慮測序成本,還需要考慮相關的計算成本,如果市場上有任何其他測序儀,他們將需要的存儲成本。當我們談論 X 時,我談到的一件事是,僅與 NovaSeq X 相關的計算節省就可以在 4 年、5 年內為您節省超過 100 萬美元。所以這對他們來說真的很令人興奮。忘記房地產要求,忘記後處理數據所需的時間。所有這些都很重要,但他們也看到,由於這些內置功能,X 的總擁有成本要低得多。

  • Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

    Joydeep Goswami - CFO, Chief Strategy & Corporate Development Officer

  • Yes. I mean, Francis, just to dovetail on that, right, David, you had asked about, yes, there are cash constraints with people trying to reduce cash burn. But it's important to understand that, A, sequencing is at the very heart of the value that these companies are generating and even academic institutions are generating, right? So they want to do more sequencing because sequencing gives them answers that other technologies are not giving them and at scale.

    是的。我的意思是,弗朗西斯,只是為了吻合這一點,對,大衛,你問過,是的,人們試圖減少現金消耗存在現金限制。但重要的是要明白,A,測序是這些公司甚至學術機構正在創造的價值的核心,對吧?所以他們想做更多的測序,因為測序給了他們其他技術沒有給他們的答案,而且是大規模的。

  • I think the second point that Francis mentioned is really important, right, that when they look at their cash burn, something like the X or a NextSeq 1000/2000 actually allows them to reduce their expenditure elsewhere, like things around storage or compute or other things, right, and allows them to redirect their investments more positively into areas that add value. And that's a really important point as you think through.

    我認為 Francis 提到的第二點非常重要,對吧,當他們查看他們的現金消耗時,像 X 或 NextSeq 1000/2000 這樣的東西實際上允許他們減少其他地方的支出,比如存儲或計算或其他方面的支出事情,正確的,並允許他們將投資更積極地重新定向到增值領域。當你仔細考慮時,這是非常重要的一點。

  • And then the third thing is just what they're doing in elasticity, demand elasticity or new applications that Francis and Susan and others have pointed out earlier, which is moving to things that they have not done with the NovaSeq 6000s or any other instruments before, which really then pulls through the elasticity that we are expecting to see starting in 2023 but really picking up in 2024 and beyond as the Xs become fully entrenched.

    然後第三件事就是他們在彈性、需求彈性或 Francis 和 Susan 以及其他人之前指出的新應用方面正在做的事情,這就是他們正在轉向他們以前沒有用 NovaSeq 6000s 或任何其他儀器做過的事情,然後真正拉動了我們預計從 2023 年開始看到的彈性,但隨著 Xs 變得完全根深蒂固,它在 2024 年及以後真正回升。

  • Operator

    Operator

  • And with that, that is all the time we have for our question-and-answer session. I would now like to turn the call back over to Salli Schwartz for any additional or closing remarks.

    這就是我們問答環節的全部時間。我現在想將電話轉回給 Salli Schwartz,以徵求任何補充意見或結束意見。

  • Sallilyn Schwartz - VP of IR

    Sallilyn Schwartz - VP of IR

  • Well, thank you for joining us today. As a reminder, a replay of this call will be available in the Investors section of our website. This concludes our call, and we look forward to seeing you at upcoming conferences and other events.

    好吧,謝謝你今天加入我們。提醒一下,本次電話會議的重播將在我們網站的“投資者”部分提供。我們的電話到此結束,我們期待在即將舉行的會議和其他活動中見到您。

  • Operator

    Operator

  • And this concludes today's call. You may disconnect.

    今天的電話會議到此結束。您可能會斷開連接。