Grail Inc (GRAL) 2024 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good day, ladies and gentlemen, and welcome to the GRAIL third-quarter 2024 earnings call. (Operator Instructions) Please be advised that this conference call is being recorded.

    女士們、先生們,美好的一天,歡迎參加 GRAIL 2024 年第三季財報電話會議。(操作員說明)請注意,本次電話會議正在錄音。

  • GRAIL Investor Relations, please begin.

    GRAIL 投資者關係部,請開始。

  • Unidentified Company Representative

    Unidentified Company Representative

  • Thank you, and thank you all for joining us today. On the call are Bob Ragusa, our Chief Executive Officer; Aaron Freidin, our Chief Financial Officer; Dr. Joshua Ofman, our President; and sir Harpal Kumar, our President, International Business and BioPharma.

    謝謝大家,也謝謝大家今天加入我們。接聽電話的是我們的執行長鮑勃·拉古薩 (Bob Ragusa); Aaron Freidin,我們的財務長;我們的總裁約書亞·奧夫曼博士;以及我們的國際業務和生物製藥總裁 Harpal Kumar 爵士。

  • Before we get underway, I'd like to remind everyone that we'll be making forward-looking statements on this call based on current expectations. It's our intent that all statements other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity will be covered by the Safe Harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21 of the Securities Exchange Act of 1934, as amended.

    在我們開始之前,我想提醒大家,我們將根據目前的預期對本次電話會議做出前瞻性聲明。我們的目的是,今天電話會議期間除歷史事實陳述之外的所有陳述,包括有關我們預期財務業績和商業活動的陳述,都將受到1933 年《證券法》第27A 條中包含的前瞻性陳述的安全港條款的保護經修訂的《1934 年證券交易法》第 21 條(經修訂)。

  • 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 currently available information, and GRAIL assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL files with the SEC, including the Risk Factors section in GRAIL's most recent quarterly report on Form 10-Q.

    前瞻性陳述存在風險和不確定性。實際事件或結果可能與預測或討論的事件或結果有重大差異。所有前瞻性陳述均基於當前可用信息,GRAIL 不承擔更新這些陳述的義務。為了更了解可能導致實際結果出現差異的風險和不確定性,我們建議您參閱 GRAIL 向 SEC 提交的文件,包括 GRAIL 最新季度報告 10-Q 表格中的「風險因素」部分。

  • This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss and adjusted EBITDA, which are adjusted to exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of GRAIL's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website.

    此次電話會議還將討論 GAAP 結果和某些非 GAAP 財務指標,包括調整後的毛利或虧損和調整後的 EBITDA,這些指標經過調整以排除某些特定項目。我們的非 GAAP 財務指標旨在補充您對 GRAIL 財務狀況的理解。今天發布的新聞稿中提供了非公認會計準則衡量指標與最直接可比較的公認會計準則財務衡量指標的調節表,該新聞稿發佈在我們的網站上。

  • And with that, I'll hand the call to Bob.

    然後,我會將電話轉給鮑伯。

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • Good afternoon, everyone, and thank you for joining us to review results for the third quarter. We remain pleased with the demand for Galleri that we are seeing in the pre-reimbursement environment. Through September 30 of this year, more than 250,000 commercial Galleri tests have been prescribed by more than 12,000 healthcare providers since launch. GRAIL is an established market leader in the field, and we are proud of the demonstrated impact that Galleri is having on patients' lives. Galleri was designed for population scale, and GRAIL continues to optimize our technology and laboratory infrastructure to enable future growth.

    大家下午好,感謝您與我們一起回顧第三季的業績。我們對預報銷環境中對 Galleri 的需求感到滿意。自推出以來,截至今年 9 月 30 日,Galleri 商業檢測已為超過 12,000 家醫療保健提供者開立了超過 250,000 種商業檢測處方。GRAIL 是該領域公認的市場領導者,我們為 Galleri 對患者生活所產生的顯著影響感到自豪。Galleri 是針對人口規模而設計的,GRAIL 不斷優化我們的技術和實驗室基礎設施,以實現未來的成長。

  • At the end of this year, we will launch the next version of the Galleri test. With the new assay, we have integrated a significant level of automation, among other efficiencies to support volume at scale and enable reductions in costs over time. Additionally, our large laboratory facility of approximately 200,000 square feet in Research Triangle Park, North Carolina, enables us to scale laboratory capacity substantially from multiple years of growth. We continue to present evidence demonstrating Galleri's performance at renowned medical conferences and published the results in leading peer review publications. In September, JCO Precision Oncology published a subanalysis from our CCGA and PATHFINDER studies in prostate cancer.

    今年年底,我們將推出下一版的 Galleri 測試。透過新的檢測,我們整合了顯著的自動化以及其他效率,以支援大規模的產量並隨著時間的推移降低成本。此外,我們位於北卡羅來納州三角研究園區的大型實驗室設施佔地約 20 萬平方英尺,使我們能夠透過多年的成長大幅擴大實驗室容量。我們繼續提供證據證明 Galleri 在著名醫學會議上的表現,並在領先的同行評審出版物上發表結果。9 月,JCO Precision Oncology 發表了我們針對前列腺癌的 CCGA 和 PATHFINDER 研究的子分析。

  • For prostate cancer, in general, overdiagnosis of indolent cancers is a particular concern. The analysis demonstrated that when Galleri detected prostate cancer, most were high grade and clinically significant and usually indicative of aggressive disease, where additional diagnostic evaluation is necessary. These data previously shared at AACR in March build out earlier findings regarding Galleri's preferential detection of aggressive, deadly cancers. This is important because any screening paradigm when designed for population scale in addition to standard-of-care screening should not exasperate overdiagnosis of indolent cancers.

    一般來說,對於攝護腺癌,惰性癌症的過度診斷是一個特別值得關注的問題。分析表明,當 Galleri 檢測到前列腺癌時,大多數為高級別且具有臨床意義,通常表明患有侵襲性疾病,需要進行額外的診斷評估。3 月在 AACR 上分享的這些數據建立了有關 Galleri 優先檢測侵襲性致命癌症的早期發現。這很重要,因為除了標準護理篩檢之外,任何針對人口規模設計的篩檢模式都不應該加劇惰性癌症的過度診斷。

  • In October, GRAIL presented early results from the reflection real-world evidence study of Galleri at the Early Detection of Cancer Conference. In this study, a diverse population of approximately 2,800 veterans from the US Department of Veteran Affairs sites with toxic exposure but with no symptoms suggestive of cancer were evaluated. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate of 1.3% and a positive predictive value of 42.9%. More than half of the cases were identified at early stage of 1 to 3.

    10 月,GRAIL 在癌症早期檢測會議上展示了 Galleri 反思現實世界證據研究的早期結果。在這項研究中,對來自美國退伍軍人事務部站點的大約 2,800 名退伍軍人進行了評估,這些退伍軍人曾經接觸過有毒物質,但沒有提示癌症的症狀。初步結果顯示,在研究參與者中,退伍軍人群組的癌症訊號檢出率為 1.3%,陽性預測值為 42.9%。超過一半的病例是在 1 至 3 的早期階段發現的。

  • To discuss our second-quarter financial results, I'll turn it over to GRAIL's Chief Financial Officer, Aaron Freidin.

    為了討論我們第二季的財務業績,我將把它交給 GRAIL 的財務長 Aaron Freidin。

  • Aaron Freidin - Chief Financial Officer

    Aaron Freidin - Chief Financial Officer

  • Thanks, Bob, and good afternoon, everyone. I'm pleased to present our results for the third quarter.

    謝謝鮑勃,大家下午好。我很高興介紹我們第三季的業績。

  • Third-quarter results were strong with revenue of $28.7 million, up $7.9 million or 38% as compared to Q3 2023. Total revenue for the quarter is comprised of $25.4 million of screening revenue and $3.3 million of development services revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development.

    第三季業績強勁,營收為 2,870 萬美元,比 2023 年第三季增加 790 萬美元,成長 38%。該季度的總收入包括 2540 萬美元的放映收入和 330 萬美元的開發服務收入。開發服務收入包括我們向生物製藥和臨床客戶提供的服務,包括臨床研究、試點測試、研究和治療開發的支援。

  • We see continued demand for our Galleri test and sold approximately 32,600 tests in the third quarter, which historically has been our slowest quarter of the calendar due to summer holidays. Screening revenue of $25.4 million in the third quarter was up 52% as compared with the third quarter of 2023, primarily based on an increase in sales volume in Q3 2024 as compared to the same quarter last year. Net loss for the quarter was $125.7 million, an improvement of 86% as compared to Q2 2023, which was impacted by a large goodwill and intangible asset impairment.

    我們看到對 Galleri 測試的需求持續成長,並在第三季售出約 32,600 個測試,由於暑假,這是歷史上我們最慢的季度。第三季的放映收入為 2,540 萬美元,較 2023 年第三季成長 52%,主要是由於 2024 年第三季的銷售量較去年同期有所成長。本季淨虧損為 1.257 億美元,較 2023 年第二季改善 86%,受到大量商譽和無形資產減損的影響。

  • We additionally report non-GAAP financial measures to enhance investors' understanding of our business. These measures include adjusted gross profit or loss and adjusted EBITDA, and exclude accounting impacts related to Illumina's acquisition of GRAIL. We encourage investors to carefully consider results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations available in our third quarter earnings press release. Non-GAAP adjusted gross profit for the second quarter of 2024 was $11.8 million, an increase of $4.8 million or 68% as compared with Q3 2023. Primary drivers of the increased margin were revenue mix and the efficiencies of scale related to increased Galleri volume.

    我們也報告非公認會計準則財務指標,以增強投資者對我們業務的了解。這些指標包括調整後的毛利或虧損以及調整後的 EBITDA,並且不包括與 Illumina 收購 GRAIL 相關的會計影響。我們鼓勵投資者仔細考慮公認會計原則下的結果,結合我們的補充非公認會計原則資訊以及我們第三季收益新聞稿中提供的這些簡報之間的調節。2024 年第二季非 GAAP 調整後毛利為 1,180 萬美元,較 2023 年第三季增加 480 萬美元,增幅 68%。利潤增加的主要驅動因素是收入組合以及與 Galleri 銷售增加相關的規模效率。

  • Adjusted EBITDA for the second quarter of 2024 was a negative $108.2 million, representing an improvement of $17.9 million or 14% as compared to Q3 2023, and we ended the quarter with a cash position of $853.6 million. We continue to expect reductions in our cash burn in line with the guidance we provided last quarter. In August, we lowered our second half cash burn guidance from $250 million to $220 million. Additionally, we guided full year burn for 2025, expected to be approximately $325 million.

    2024 年第二季調整後 EBITDA 為負 1.082 億美元,與 2023 年第三季相比增加了 1,790 萬美元,即 14%,本季末我們的現金部位為 8.536 億美元。我們繼續預計現金消耗將減少,與我們上季度提供的指導一致。8 月份,我們將下半年現金消耗指引從 2.5 億美元下調至 2.2 億美元。此外,我們預計 2025 年全年燒錢約為 3.25 億美元。

  • Given our experience through the first nine months, we are narrowing our guidance for Galleri sales for 2024 to be between 40% and 50% growth when compared to 2023. As a reminder of the expected impact of the restructuring we announced in the last quarter, we plan for Galleri revenue to grow more moderately after 2024, until we receive broad reimbursement. With our reduced spending profile, our cash balance provides runway into 2028.

    根據前 9 個月的經驗,我們將 2024 年 Galleri 銷售額的指導範圍縮小到與 2023 年相比成長 40% 至 50%。為了提醒我們上季度宣布的重組的預期影響,我們計劃在 2024 年後讓 Galleri 的收入成長更加溫和,直到我們獲得廣泛的補償。隨著支出規模的減少,我們的現金餘額為 2028 年提供了保障。

  • I will turn it back to Bob for concluding remarks.

    我將把它轉回給鮑伯做總結發言。

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • Thank you, Aaron. We are a mission-driven company, and we are focused on improving cancer care and enabling broad use of Galleri. We are focused on our strategic goals, seeking FDA approval of Galleri and pursuing broad reimbursement for Galleri. In terms of upcoming milestones, this year, we expect to continue enrollment in the Galleri-Medicare or REACH study, drive access to Galleri, and advance our commercial and research partnerships. We also anticipate transitioning to a new version of Galleri, which will enable us to scale efficiently as Galleri demand increases.

    謝謝你,亞倫。我們是一家以使命為導向的公司,我們致力於改善癌症護理並實現 Galleri 的廣泛使用。我們專注於我們的策略目標,尋求 FDA 對 Galleri 的批准,並為 Galleri 尋求廣泛的報銷。就即將到來的里程碑而言,今年我們預計將繼續參與 Galleri-Medicare 或 REACH 研究,推動進入 Galleri,並推動我們的商業和研究合作夥伴關係。我們也預計過渡到新版本的 Galleri,這將使我們能夠隨著 Galleri 需求的增加而有效地擴展。

  • We are looking forward to the expected readouts of our registrational studies and anticipate results from the first 25,000 participants in the PATHFINDER 2 study in the second half of 2025, and the full results from the NHS-Galleri study in 2026.

    我們期待註冊研究的預期結果,並預計 2025 年下半年 PATHFINDER 2 研究的前 25,000 名參與者的結果,以及 2026 年 NHS-Galleri 研究的完整結果。

  • With that, we'll turn the call over to Q&A. Operator, please go ahead.

    這樣,我們將把通話轉入問答環節。接線員,請繼續。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Subbu Nambi, Guggenheim.

    蘇布南比,古根漢。

  • Unidentified Participant

    Unidentified Participant

  • It's Thomas on for Subbu. A decade into the GRAIL journey, can you walk through some of the progress that has been made and give a little bit more color on the outlook for Galleri reimbursement, the test FDA regulatory pathway, and then just your commercial strategy in general especially if it comes to that new test? What comes next? And specifically, when do you expect to be in front of the FDA regulatory pathway, and how long after would you envision CMS reimbursement?

    湯瑪斯替補蘇布。GRAIL 之旅已經過去了十年,您能否回顧一下已經取得的一些進展,並對 Galleri 報銷的前景、測試 FDA 監管途徑以及您的整體商業策略(特別是如果它來參加新的考驗嗎?接下來會發生什麼事?具體來說,您預計什麼時候能夠進入 FDA 監管途徑,以及您預計 CMS 報銷後需要多長時間?

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • A fair amount to unpack there. So I guess, maybe focusing first on the FDA pathway. So we've now in July completed the study visits for our two key registrational studies. So PATHFINDER 2, where we've enrolled 35,000 people, and the NHS-Galleri study, we're enrolled 140,000 people in that.

    在那裡打開包裝相當多。所以我想,也許先關注 FDA 途徑。現在,我們已於 7 月完成了兩項關鍵註冊研究的考察訪問。因此,我們在 PATHFINDER 2 中招募了 35,000 人,在 NHS-Galleri 研究中,我們招募了 14 萬人。

  • That's the clinical data across that 175,000 people, where we will use to submit for our PMA and the submission time is the first half -- first half of 2026. And so from that, we do expect an advisory committee at the FDA. And so we expect about a one-year timeline from that, which would drive us into first half 2027 for FDA approval. It's the tentative timeline that we're working towards.

    這是 175,000 人的臨床數據,我們將用它來提交 PMA,提交時間是上半年——2026 年上半年。因此,我們確實期望 FDA 成立一個諮詢委員會。因此,我們預計此後的時間表約為一年,這將使我們在 2027 年上半年獲得 FDA 批准。這是我們正在努力實現的暫定時間表。

  • As mentioned in the question, the next version of the assay, so one of the things we recognize is that the Galleri test has always been built for population scale. And with the next version of the assay, we really looked to two things: one, nearly fully automate the assay itself till it gets great scalability. And with that also comes cost reduction. So we expect near-term variable cost reduction from the assay. And then longer term, as we get volume, we expect fixed cost leverage from the assay. So we're looking to transition to that new assay at the end of this year.

    正如問題中提到的,下一個版本的檢測,所以我們認識到的一件事是,Galleri 測試始終是針對人口規模而建立的。對於下一個版本的檢測,我們真正關注了兩件事:第一,檢測本身幾乎完全自動化,直到它獲得巨大的可擴展性。隨之而來的是成本的降低。因此,我們預計該檢測的短期變動成本會降低。然後從長遠來看,當我們獲得數量時,我們預計檢測會產生固定成本槓桿。因此,我們希望在今年年底過渡到新的檢測方法。

  • And then on the reimbursement pathway, clearly, CMS is an important element of that. There is the MCED law going through congress right now. In the summer, it had a markup in the House Ways and Means Committee, where we had a rather rare and unusual unanimous vote for it, 38 to 0, and so we're very encouraged by that. We're encouraged by the large stakeholder groups that are advocating for the bill. One of the things that's very clear is that cancer is not a partisan issue. So we have bipartisan, bicameral support for the bill.

    然後,在報銷途徑上,顯然,CMS 是其中的一個重要組成部分。MCED 法目前正在國會通過。今年夏天,眾議院籌款委員會對該法案進行了加價,我們以 38 比 0 的投票結果獲得了相當罕見且不尋常的一致投票,因此我們對此感到非常鼓舞。我們對倡導該法案的大型利益相關團體感到鼓舞。非常清楚的一件事是,癌症不是黨派問題。因此,該法案得到了兩黨、兩院的支持。

  • And so we're really highly encouraged by that plus just the support networks that are -- and sponsors for the bill. But given the nature of our congress and any of the lack of productivity in congress in the last year or so, it's difficult to predict timing on that. But we're hopeful that before we get FDA approval, we will have the bill pass, and that would give CMS the authority to be able to cover an FDA-approved MCED test.

    因此,我們對此感到非常鼓舞,再加上法案的支持網絡和贊助商。但考慮到我們國會的性質以及過去一年左右國會生產力的缺乏,很難預測具體時間。但我們希望在獲得 FDA 批准之前,該法案能夠獲得通過,這將使 CMS 有權承保 FDA 批准的 MCED 測試。

  • So maybe I'll stop there and see if there's any follow-on.

    所以也許我會停在那裡,看看是否有任何後續行動。

  • Unidentified Participant

    Unidentified Participant

  • Awesome. And then just one more building off of that. You mentioned cash balance. How do you manage your commercial efforts given everything that you just said and that spend?

    驚人的。然後再在此基礎上再建造一棟建築物。您提到了現金餘額。鑑於您剛才所說的一切和支出,您如何管理您的商業工作?

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • Yeah. So I think one of the things we did in the restructuring in August is we looked at our spend across the organization and really focused on our North Star of getting Galleri FDA approved and reimbursed. Within that, we've recognized that as an early-stage unreimbursed test that the -- it's really an investment in commercial. And as you can see, from this quarter's results, we know that if we invest in commercial, we can drive sales and drive sales rapidly.

    是的。因此,我認為我們在 8 月的重組中所做的一件事是,我們審視了整個組織的支出,並真正專注於讓 Galleri FDA 批准和報銷的北極星。其中,我們認識到,作為一項早期無償測試,它確實是一項商業投資。而且正如你所看到的,從本季的業績來看,我們知道,如果我們投資於商業,我們可以推動銷售並快速推動銷售。

  • In August, we looked at moderating that, the amount of investment in there in order to extend our cash runway out into 2028. And so right now, we're prioritizing that cash runway. And on the commercial side, what we're really looking to do is to drive that to be more cost neutral so that the margin generated by the tests that they're selling can cover the -- at least cover the commercial expenses. So it's a more moderate approach.

    8 月份,我們考慮調整投資金額,以便將我們的現金跑道延長至 2028 年。所以現在,我們優先考慮現金跑道。在商業方面,我們真正想做的是推動成本更加中性,以便他們銷售的測試產生的利潤可以覆蓋——至少覆蓋商業費用。所以這是一個比較溫和的方法。

  • We've learned a lot about what works and doesn't work. So we've been able to concentrate our commercial efforts on the most productive areas and pull back from some of the other areas. And so we think we'll continue to learn as we go even at a more moderated pace, but that is the expectation.

    我們已經了解了很多關於什麼有效、什麼無效的知識。因此,我們能夠將商業努力集中在生產力最高的領域,並從其他一些領域中撤出。因此,我們認為我們將繼續學習,甚至以更溫和的速度進行,但這只是我們的期望。

  • Operator

    Operator

  • Tejas Savant, Morgan Stanley.

    Tejas Savant,摩根士丹利。

  • Unidentified Participant

    Unidentified Participant

  • This is Jason on for Tejas. So GRAIL is going to be the first mover in the MCED market. Obviously, the market right now is very nascent, and you have to build awareness for a technology for both physicians and patients. So with potential FDA approval in establishing reimbursement two years away, give or take, can you talk about any plans you have to build the MCED market in the next year or two before reimbursement?

    這是傑森在光輝號上的表現。因此,GRAIL 將成為 MCED 市場的先驅。顯然,現在的市場還處於萌芽階段,您必須提高醫生和患者對科技的認識。因此,隨著 FDA 可能在兩年後批准建立報銷,您能談談在報銷前的未來一兩年內建立 MCED 市場的計劃嗎?

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • Sure. So over -- both over the last couple of years, while it's going into the near future, we're going to look to -- we've looked to really build out how the ecosystem works. And so what we want -- part of wanting to drive the commercial experience here is to get providers, health systems, very comfortable with the test know-how to how to operate with the test and really integrate it into their standard practices. And so we've been very successful at that aspect of it. And so we will continue to push on that and understand what resonates with providers, what resonates with patients in terms of how we describe the test.

    當然。因此,在過去的幾年裡,在不久的將來,我們將著眼於真正建立生態系統的運作方式。因此,我們想要推動商業體驗的一部分是讓提供者、衛生系統非常熟悉測試知識,了解如何操作測試並將其真正整合到他們的標準實踐中。所以我們在這方面非常成功。因此,我們將繼續推動這一目標,並根據我們如何描述測試來了解什麼與提供者產生共鳴,什麼與患者產生共鳴。

  • And then from a very practical standpoint, making sure our laboratory is able to deliver high-quality tests in a very timely manner. So just kind of exercising the whole ecosystem is very important. Because, again, this is a population scale test that has been designed, and so we expect to operate at very high volumes. And so while we're already upgrading at reasonably high volumes, when we get to the next stage of broad reimbursement, the volumes will go up exponentially, and we'll need to be prepared for that.

    然後從非常實際的角度來看,確保我們的實驗室能夠非常及時地提供高品質的測試。因此,鍛鍊整個生態系統非常重要。因為,這是一個已經設計好的人口規模測試,所以我們期望以非常大的數量來操作。因此,雖然我們已經以相當高的數量進行升級,但當我們進入下一階段的廣泛報銷時,數量將呈指數級增長,我們需要為此做好準備。

  • Unidentified Participant

    Unidentified Participant

  • Got it. And then as a follow-up, on version 2 of Galleri, you've mentioned that the main goals produce a scalable version of the test. Can you confirm if you anticipate any major performance differences for the version 2 compared to the current version? And additionally, can you confirm what bridging studies you might do with respect to the studies you're submitting as part of the PMA submission?

    知道了。然後,作為後續,在 Galleri 的第 2 版中,您提到主要目標是產生測試的可擴展版本。您能否確認,與目前版本相比,您預期版本 2 是否會出現重大效能差異?此外,您能否確認您可能會對作為 PMA 提交的一部分提交的研究進行哪些橋接研究?

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • Yeah. So we -- while we expect some minor improvements in the performance from a end-user perspective, we would not expect a significant difference in the actual performance of the test. The main drivers here are, as we mentioned, scalability and cost. On both studies in terms of -- from an FDA perspective, we're in discussions with them on the appropriate bridging studies for the next version of the assay from the current version. And as we go later on, we'll have similar discussions with the NHS, if they want to move forward in the full-scale deployment.

    是的。因此,雖然我們預計從最終用戶的角度來看效能會有一些微小的改進,但我們預期測試的實際效能不會有顯著差異。正如我們所提到的,這裡的主要驅動因素是可擴展性和成本。從 FDA 的角度來看,這兩項研究正在與他們討論當前版本檢測方法的下一版本的適當橋接研究。稍後,如果 NHS 想要推進全面部署,我們將與他們進行類似的討論。

  • Operator

    Operator

  • Vijay Kumar, Evercore ISI.

    維傑·庫馬爾,Evercore ISI。

  • Mackenzie Strehle - Analyst

    Mackenzie Strehle - Analyst

  • This is Mackenzie on for Vijay. Just another question on cash burn. How should we be thinking about phasing of that through 2025? I know you gave us a number, but is this something that's going to be spread evenly across the quarters? Or do you expect that to improve sequentially throughout the year?

    這是麥肯齊替維傑發言。關於現金消耗的另一個問題。我們應該如何考慮在 2025 年之前分階段實現這一目標?我知道你給了我們一個數字,但是這個數字會均勻分佈在各個季度嗎?或者您預計這種情況會在全年中持續改善?

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • Aaron, do you want to grab one?

    亞倫,你想買一個嗎?

  • Aaron Freidin - Chief Financial Officer

    Aaron Freidin - Chief Financial Officer

  • Yeah. Great question. So we'd expect cash burn to decrease in subsequent years as we continue to grow revenues and investments in some of the programs that we've been talking about, getting to PMA submission, getting to the next version of the test roll-off.

    是的。很好的問題。因此,隨著我們繼續增加我們一直在談論的一些項目的收入和投資,提交 PMA,進入下一個版本的測試,我們預計現金消耗在接下來的幾年中會減少。

  • Mackenzie Strehle - Analyst

    Mackenzie Strehle - Analyst

  • Okay. Great. That's helpful. And then I know you talked about in the new version of Galleri, this is supposed to reduce your COGS, but it sounds like it's going to take a little bit of time for that to ramp. So how should we be thinking about how long that ramp to sort of a normalized COGS run rate will take? And what can we expect on the margin front there?

    好的。偉大的。這很有幫助。然後我知道你在新版本的 Galleri 中談到,這應該會減少你的 COGS,但聽起來需要一點時間才能實現。那麼,我們應該如何考慮達到正常化的銷貨成本運作率需要多長時間呢?我們對利潤率有何期望?

  • Aaron Freidin - Chief Financial Officer

    Aaron Freidin - Chief Financial Officer

  • Yeah. So hard to predict right now from a timing perspective. But it's going to be a -- there'll be an impact to begin with on the variable front. Part of the main driver for that program was to bring down the cost of the test and then increase the throughput. So there'll be some pick-up to begin with, but we won't realize the entire benefits of that test, the cost of that test until we get into significantly more volume than we're at today.

    是的。從時間角度來看,現在很難預測。但這將首先對變數方面產生影響。該計劃的部分主要驅動力是降低測試成本,然後提高吞吐量。因此,一開始會有一些回升,但我們不會意識到該測試的全部好處和測試的成本,直到我們的數量比今天大得多。

  • That's something, as we transition to that test at the end of this year, run it for the following quarters, we'll be able to give more line of sight to that.

    這是一件事情,當我們在今年年底過渡到該測試並在接下來的幾個季度運行它時,我們將能夠對此給予更多的關注。

  • Operator

    Operator

  • There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks.

    目前沒有其他問題。現在我將把電話轉回給 GRAIL 進行結束語。

  • Robert Ragusa - Chief Executive Officer

    Robert Ragusa - Chief Executive Officer

  • I want to thank everyone for joining today's call.

    我要感謝大家參加今天的電話會議。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes the call. You may now disconnect.

    女士們、先生們,電話會議到此結束。您現在可以斷開連線。