Bionano Genomics Inc (BNGO) 2022 Q4 法說會逐字稿

Good day, and welcome to the Bionano Fourth Quarter and Full Year 2022 Earnings Conference Call. (Operator Instructions)

美好的一天，歡迎來到 Bionano 第四季度和 2022 年全年收益電話會議。 （操作員說明）

At this time, I would like to turn the conference over to Amy Conrad from Investor Relations. Please go ahead.

此時，我想將會議轉交給投資者關係部的 Amy Conrad。請繼續。

Thank you, Michelle, and good afternoon, everyone. Welcome to the Bionano Genomics Fourth Quarter and Full Year 2022 Financial Results Conference Call. Leading the call today is Dr. Erik Holmlin, CEO of Bionano. He is joined by Chris Stewart, CFO of Bionano. After market closed today, Bionano issued a press release announcing its financial results for the fourth quarter and full year 2022. A copy of the release can be found on the Investor Relations page of the company's website.

謝謝你，米歇爾，大家下午好。歡迎參加 Bionano Genomics 第四季度和 2022 年全年財務業績電話會議。 Bionano 首席執行官 Erik Holmlin 博士今天主持了此次電話會議。 Bionano 的首席財務官 Chris Stewart 加入了他的行列。今天收市後， Bionano 發布了一份新聞稿，宣布了其第四季度和 2022 年全年的財務業績。可在公司網站的投資者關係頁面上找到該新聞稿的副本。

I would like to remind everyone that certain statements made during this conference call are forward-looking, including statements about Bionano's strategic and commercialization plans, sales pipeline, future fundraising activities and prospects; anticipated benefits or improvements to the Saphyr System and Ionic Purification System, goals and anticipated milestones for 2023 and achievement of our ELEVATE! growth strategy. Our anticipated compound annual growth rate, the size and our ability to access our estimated target markets, the advantage of the Saphyr system and Ionic Purification System over current technologies, the anticipated benefit of recent acquisitions, expectations regarding timing and content of study results and anticipated benefits of these studies in driving adoption of the Saphyr system and Ionic Purification System.

我想提醒大家，本次電話會議中的某些陳述是前瞻性的，包括有關 Bionano 的戰略和商業化計劃、銷售管道、未來籌款活動和前景的陳述； Saphyr 系統和離子淨化系統的預期收益或改進、2023 年的目標和預期里程碑以及我們 ELEVATE 的實現！增長戰略。我們預期的複合年增長率、我們進入估計目標市場的規模和能力、Saphyr 系統和離子淨化系統相對於當前技術的優勢、近期收購的預期收益、對研究結果的時間和內容的預期以及預期這些研究在推動採用 Saphyr 系統和離子淨化系統方面的好處。

Such forward-looking statements are based upon current expectations, and there can be no assurances that the results contemplated in these statements will be realized. Actual results may differ materially from such statements due to a number of factors and risks, some of which are identified in Bionano's press release and Bionano's reports filed with the SEC. These forward-looking statements are based on information available to Bionano today, and the company assumes no obligation to update statements as circumstances change.

此類前瞻性陳述基於當前預期，無法保證這些陳述中預期的結果將會實現。由於多種因素和風險，實際結果可能與此類聲明存在重大差異，其中一些因素和風險已在 Bionano 的新聞稿和 Bionano 向美國證券交易委員會提交的報告中確定。這些前瞻性陳述基於 Bionano 今天可獲得的信息，公司不承擔根據情況變化更新陳述的義務。

In addition, supplement Bionano's financial results recorded in accordance with U.S. generally accepted accounting principles or GAAP, the company is reporting non-GAAP operating expense. This non-GAAP financial measure is not meant to be considered in isolation or as a substitute for comparable GAAP measures, should be read in conjunction with the company's consolidated financial statements prepared in accordance with GAAP has no standardized meanings described by GAAP and is not prepared under any comprehensive set of accounting rules or principles. A description of non-GAAP operating expense and reconciliation of non-GAAP operating expense to GAAP operating expense are included at the end of the company's earnings release issued earlier today, which has been posted on the Investor Relations page of the company's website. An audio recording and webcast replay for today's conference call will also be available online in the Investors section of the company's website.

此外，補充 Bionano 根據美國公認會計原則或 GAAP 記錄的財務業績，該公司正在報告非 GAAP 運營費用。此非 GAAP 財務指標不應孤立地考慮或替代可比的 GAAP 指標，應與公司根據 GAAP 編制的合併財務報表一起閱讀，沒有 GAAP 描述的標準化含義，也未編制根據任何一套全面的會計規則或原則。非 GAAP 運營費用的描述以及非 GAAP 運營費用與 GAAP 運營費用的對賬包含在公司今天早些時候發布的收益報告的末尾，該報告已發佈在公司網站的投資者關係頁面上。今天電話會議的錄音和網絡直播重播也將在公司網站的投資者部分在線提供。

With that, I will now turn the call over to Erik.

有了這個，我現在將把電話轉給埃里克。

Thank you, Amy, and good afternoon, everyone. Thank you for joining us today. I want to start off by saying that 2022 was simply a spectacular year for Bionano. We really couldn't be happier with the results. And in fact, we're just blown away with what we see as progress around the world in adopting optical genome mapping. We started 2022 in a pretty difficult macro environment. There was continued uncertainty around COVID, which was limiting our access to laboratories and impacting our ability to install the Saphyr system. We faced challenges with chip suppliers and production yields were lower than anticipated.

謝謝你，艾米，大家下午好。感謝您今天加入我們。首先，我想說 2022 年對 Bionano 來說簡直是輝煌的一年。我們真的對結果感到非常高興。事實上，我們對世界各地採用光學基因組作圖的進展感到震驚。我們在一個相當困難的宏觀環境中開始了 2022 年。圍繞 COVID 的不確定性持續存在，這限制了我們進入實驗室並影響了我們安裝 Saphyr 系統的能力。我們面臨芯片供應商的挑戰，生產良率低於預期。

And I'm happy to report that over the course of the year, we were able to get production yields back up and restore them to levels that they were previously. And then we hit our installed base milestone for Saphyr systems for the year. And never once did we face any backlog or any inability to ship product to customers based on supply chain issues. And that's a credit to so many incredible employees across our company who battled through difficult conditions to produce a great result, and I'm thankful to them.

我很高興地報告，在這一年中，我們能夠恢復生產產量並將其恢復到以前的水平。然後我們達到了今年 Saphyr 系統的安裝基礎里程碑。我們從來沒有遇到過任何積壓或無法根據供應鏈問題將產品運送給客戶的情況。這要歸功於我們公司眾多出色的員工，他們在艱難的條件下奮戰，取得了出色的成績，我很感謝他們。

We kicked off our strategy for growth, which we named ELEVATE! at the start of 2022, and we delivered against all of our ELEVATE! milestones for the year. We met or exceeded our guidance for revenues on both a full year basis and in each quarter over the course of the year. I'd like to take a little bit of time to share with you some highlights from our 2022 achievements, including those in the fourth quarter. To begin, we grew the installed base of Saphyr systems in the world to 240, which represents a 46% increase over the 164 systems that were installed at the end of 2021.

我們啟動了增長戰略，我們將其命名為 ELEVATE！在 2022 年初，我們兌現了我們所有的 ELEVATE！年的里程碑。我們在全年和全年的每個季度都達到或超過了我們的收入指導。我想花一點時間與大家分享我們 2022 年成就的一些亮點，包括第四季度的成就。首先，我們將全球 Saphyr 系統的安裝基數增加到 240 個，比 2021 年底安裝的 164 個系統增加了 46%。

In the fourth quarter of 2022, we sold 4,781 flow cells, which represents 49% growth over the same period in 2021 and brought the total for 2022 to 15,375 flow cells sold. That represents a 23% growth over the 12,518 flow cells sold in 2021. And that's just tremendous progress. You have to remember that the flow cell is the unit consumable that really connects most closely to the number of human genomes that are being analyzed by optical genome mapping. And so this growth is truly impressive.

2022 年第四季度，我們售出了 4,781 個流通池，比 2021 年同期增長了 49%，使 2022 年的流通池總銷量達到 15,375 個。與 2021 年售出的 12,518 個流通池相比，增長了 23%。這是巨大的進步。您必須記住，流動槽是真正與光學基因組作圖分析的人類基因組數量聯繫最緊密的單位耗材。因此，這種增長確實令人印象深刻。

We continue to process a substantial number of samples for optical genome mapping through Bionano laboratories. And this is a vehicle that we leverage to introduce people who are interested in OGM to how powerful that data is on their samples. Revenues for the fourth quarter of 2022 were $8.2 million, which is up 30% versus the fourth quarter of 2021. Revenue for the full year was -- 2022 was $27.8 million, which represents year-over-year revenue growth of 55%. And we're incredibly impressed by the performance on the top line in the fourth quarter. And we believe it really shows what we're capable of doing in this business, both from an absolute standpoint, but on an ongoing growth basis. And so it's an outstanding outcome for our team selling optical genome mapping and our other products, clinical services and software.

我們繼續通過 Bionano 實驗室處理大量樣本以進行光學基因組作圖。我們利用這種工具向對 OGM 感興趣的人介紹該數據在他們的樣本中的強大功能。 2022 年第四季度的收入為 820 萬美元，比 2021 年第四季度增長 30%。2022 年全年收入為 2780 萬美元，同比增長 55%。我們對第四季度頂線的表現印象深刻。我們相信它確實顯示了我們在這項業務中的能力，無論是從絕對的角度，還是在持續增長的基礎上。因此，對於我們銷售光學基因組圖譜和我們其他產品、臨床服務和軟件的團隊來說，這是一個了不起的成果。

In fact, we exceeded the goals and expectations for all of our planned milestones over the course of the year and advanced the company's strategy as well as our products. I'd like to share some of those key highlights from the full year. We made significant progress towards streamlining the optical genome mapping workflow with our acquisition of Purigen Biosystems, which closed in November of 2022. That acquisition brings their Ionic system, which uses isotachophoresis technology into our optical genome mapping workflow, and we believe that it really completes the assembly of the extremely streamlined end-to-end workflow for optical genome mapping once we launch the Ionic system and its consumables for OGM.

事實上，我們在這一年中超出了所有計劃里程碑的目標和期望，並推進了公司的戰略和我們的產品。我想分享全年的一些重要亮點。通過收購 Purigen Biosystems，我們在簡化光學基因組作圖工作流程方面取得了重大進展，該收購於 2022 年 11 月完成。此次收購將其使用等速電泳技術的 Ionic 系統帶入了我們的光學基因組作圖工作流程，我們相信它真正完成了一旦我們推出用於 OGM 的 Ionic 系統及其耗材，組裝極其簡化的端到端光學基因組作圖工作流程。

We developed and released enhanced kits for DNA isolation and labeling in our OGM workflow, the SP-G2 labeling kit and the Bionano Prep Direct Label and Stain-G2 DNA isolation and labeling kits. These enable sample to results in as little as 3 days for cancer samples, and they are proving to dramatically increase the reliability of the workflow in customers' hands, and it's always been a key pillar of our strategy to delight customers with robust products and these new kits do exactly that. We also released an automated version of our DNA isolation chemistry, which has been done in partnership with Hamilton and is linked to their Long String VANTAGE DNA isolation robot.

我們在 OGM 工作流程中開發並發布了用於 DNA 分離和標記的增強型試劑盒、SP-G2 標記試劑盒和 Bionano Prep Direct Label 和 Stain-G2 DNA 分離和標記試劑盒。這些使癌症樣本的樣本在短短 3 天內就可以得出結果，事實證明，它們可以顯著提高客戶手中工作流程的可靠性，這一直是我們戰略的關鍵支柱，以強大的產品取悅客戶，而這些新套件正是這樣做的。我們還發布了 DNA 分離化學的自動化版本，這是與 Hamilton 合作完成的，並與他們的 Long String VANTAGE DNA 分離機器人相連。

We launched a number of optical genome mapping laboratory developed tests or LDTs through Bionano laboratories. One is for hematologic malignancies and another is for the genetic disorder FSHD1. We believe these allow health care providers to explore the clinical utility of optical genome mapping based assays through these LDTs. And we believe that this utilization will support efforts to gain coding and coverage for reimbursement by third-party payers.

我們通過 Bionano 實驗室推出了許多光學基因組作圖實驗室開發的測試或 LDT。一種用於血液系統惡性腫瘤，另一種用於遺傳性疾病 FSHD1。我們相信這些允許醫療保健提供者通過這些 LDT 探索基於光學基因組圖譜的檢測的臨床效用。我們相信，這種利用將支持通過第三方付款人獲得編碼和報銷範圍的努力。

We also met all of our milestones in our clinical studies for prenatal and postnatal and hematologic trials, including study enrollment targets, completion of our postnatal study, which has now been published as a preprint as well as the interim publication of the prenatal study, which was published in December of 2022. We also initiated our solid tumor trial. These trials are critical to providing the critical mass of data that will be used to drive medical societies to support the inclusion of optical genome mapping in their recommended first-line tests.

我們還實現了產前和產後臨床研究以及血液學試驗的所有里程碑，包括研究入組目標、完成產後研究（現已作為預印本出版）以及產前研究的臨時出版物，其中發表於 2022 年 12 月。我們還啟動了實體瘤試驗。這些試驗對於提供大量關鍵數據至關重要，這些數據將用於推動醫學協會支持將光學基因組作圖納入其推薦的一線測試中。

Several sites across the United States and Europe validated laboratory developed tests. And in the United States, they submitted applications for reimbursement codes, including Z codes and proprietary laboratory analysis or PLA codes, which enable them to get paid for optical genome mapping tests. And they have been very pleased with the level of reimbursement that's been assigned to these codes, ranging in the area of about $1,300 for constitutional genetic disorder testing, which is comparable to reimbursement rates available in the market today.

美國和歐洲的幾個站點驗證了實驗室開發的測試。在美國，他們提交了報銷代碼申請，包括 Z 代碼和專有實驗室分析或 PLA 代碼，這使他們能夠獲得光學基因組圖譜測試的報酬。他們對分配給這些代碼的報銷水平非常滿意，體質性遺傳病檢測的報銷範圍約為 1,300 美元，這與當今市場上的報銷率相當。

NXClinical Software Version 7.0, which is the version of that software enabled for OGM data analysis is being used in the field, and we are planning a full commercial release for applications in hematologic malignancies in the first half of 2023, a precommercial version of our next-generation high-throughput Saphyr system has been running in the field with excellent results, and we plan to launch that new instrument into the field this year. Initial launch will be in the first half of 2023, and we'll see adoption and installation towards the second half of the year. We expect this instrument to enable optical genome mapping analysis at substantially higher throughput compared to the Saphyr system and that it will support labs that are running much higher volumes.

NXClinical 軟件版本 7.0，這是支持 OGM 數據分析的軟件版本，正在該領域使用，我們計劃在 2023 年上半年針對血液系統惡性腫瘤的應用程序發布完整的商業版本，這是我們下一個商業前版本新一代高通量 Saphyr 系統已經在現場運行並取得了優異的成績，我們計劃今年將這款新儀器推向現場。首次發布將在 2023 年上半年進行，我們將在下半年看到採用和安裝。我們希望該儀器能夠以比 Saphyr 系統高得多的吞吐量進行光學基因組作圖分析，並且它將支持運行更高容量的實驗室。

Finally, there were a number of amazing publications that were published in 2022, and we believe they tell the story of optical genome mapping and how the future of the company will unfold. 5 groundbreaking publications that I want to outline for you today are as follows. You may remember that we talked about an incredibly powerful publication from a number of scientists at the University of Texas, MD Anderson Cancer Center, where they described the use of optical genome mapping and evaluation of myelodysplastic syndrome or MDS prognostication. And what was incredible about this paper is it showed that up to 21% of study subjects had a different prognostic risk score when optical genome mapping was used to evaluate them compared to the standard of care. That's 1 in 5 people.

最後，2022 年出版了許多令人驚嘆的出版物，我們相信它們講述了光學基因組作圖的故事以及公司的未來將如何展開。我今天要為您概述的 5 個開創性出版物如下。您可能還記得，我們談到了德克薩斯大學 MD 安德森癌症中心的許多科學家發表的一篇非常強大的文章，他們在文章中描述了光學基因組圖譜的使用以及骨髓增生異常綜合徵或 MDS 預後的評估。這篇論文令人難以置信的是，它表明當使用光學基因組圖譜與標準護理相比，多達 21% 的研究對象具有不同的預後風險評分。那是五分之一的人。

So the impact of OGM cannot be denied. This publication really underscores that. Researchers from Necker Hospital in France, found that optical genome map being detected more clinically relevant variants in 33% of MDS patients and 54% of acute myeloid leukemia samples, which is a critical demonstration of the utility of optical genome mapping to go above and beyond the standard of care. Researchers from 8 different institutes, analyzed OGMs utility for cytogenetic abnormalities in again, AML samples. And here, they found that 12% of the cases had different risk levels and were eligible for clinical trials as a result of these new findings. This inclusion in clinical trials is incredibly meaningful because it connects these patients to potentially life-saving therapeutics that they otherwise would not have had access to without the findings of OGM. So you can imagine the impact of these findings.

所以不能否認 OGM 的影響。本出版物確實強調了這一點。法國 Necker 醫院的研究人員發現，光學基因組圖譜在 33% 的 MDS 患者和 54% 的急性髓性白血病樣本中檢測到更多臨床相關變異，這是光學基因組圖譜超越實用性的重要證明護理標準。來自 8 個不同研究所的研究人員再次分析了 OGM 在 AML 樣本中對細胞遺傳學異常的效用。在這裡，他們發現 12% 的病例具有不同的風險水平，並且由於這些新發現而有資格進行臨床試驗。將這些納入臨床試驗意義重大，因為它將這些患者與可能挽救生命的療法聯繫起來，如果沒有 OGM 的發現，他們將無法獲得這些療法。所以你可以想像這些發現的影響。

Researchers from Augusta University published the first validation study to evaluate the performance of optical genome mapping versus traditional methods for hematologic neoplasms, which showed an incredibly high technical performance and concordance rate with, importantly, 100% first pass rate, meaning that the reliability of optical genome mapping in these workflows is highly reliable and does not require repetition of the test, which drives up costs for payers and delays results to patients.

奧古斯塔大學的研究人員發表了第一項評估光學基因組作圖與傳統血液腫瘤方法性能的驗證研究，該研究顯示出令人難以置信的高技術性能和一致性率，重要的是，100% 的首次通過率，這意味著光學基因組圖譜的可靠性這些工作流程中的基因組作圖非常可靠，不需要重複測試，這會增加付款人的成本並延遲患者的結果。

Finally, researchers from a foundation at Kyoto University demonstrated the utility of optical genome mapping as part of a workflow to evaluate hypoimmunogenic induced pluripotent stem cells, IPSCs and that this workflow could be used in regenerative medicine showing OGM's ability to detect off-target effects or areas where genome modification has gone array and reveals that these modified stem cells may or may not be useful in a particular patient setting. And this is an area of significant interest in the adoption of optical genome mapping for various applications in cell therapy.

最後，來自京都大學基金會的研究人員展示了光學基因組作圖作為評估低免疫原性誘導多能幹細胞 IPSC 工作流程的一部分的實用性，並且該工作流程可用於再生醫學，顯示 OGM 檢測脫靶效應或基因組修飾已經出現的領域，並揭示了這些修飾的干細胞在特定患者環境中可能有用也可能無用。這是在細胞治療的各種應用中採用光學基因組作圖的一個重要領域。

At the close of this call, I want to go through our milestones planned as part of ELEVATE! for 2023. But before doing that, I want to turn the call over to Chris Stewart, our CFO, who will review the financials for the year. Chris?

在本次電話會議結束時，我想完成我們作為 ELEVATE 的一部分計劃的里程碑！ 2023 年。但在此之前，我想把電話轉給我們的首席財務官克里斯·斯圖爾特 (Chris Stewart)，他將審查今年的財務狀況。克里斯？

Thanks, Erik. The fourth quarter of 2022 was another outstanding quarter, which capped off a great year where we achieved impressive year-over-year revenue growth and diversified our revenue across product lines and geography. With the acquisition of Purigen we now control the end-to-end OGM workflow and expect to expand our target markets.

謝謝，埃里克。 2022 年第四季度是又一個出色的季度，它為偉大的一年畫上了句號，我們實現了令人印象深刻的同比收入增長，並實現了跨產品線和地域的收入多元化。通過收購 Purigen，我們現在控制著端到端的 OGM 工作流程，並期望擴大我們的目標市場。

Now to get to the numbers. Revenue in the fourth quarter of 2022 was approximately $8.2 million, a 30% increase over the fourth quarter of 2021 and within the preliminary range of $8.1 million to $8.4 million that we provided on January 5 of this year. Revenue for the full year was $27.8 million, representing a 55% increase over the full year 2021. This year-over-year increase was driven by strong performance in all 3 of our core businesses, OGM, Bionano Labs and software and across all 3 major geographies. Gross margin for the fourth quarter of 2022 was 22% compared to 4% in the fourth quarter of 2021. For the full year, gross margin was 21% compared to 22% in 2021. The slight decrease from 2021 was mainly due to the yield challenges that we experienced beginning in late 2021. As Erik mentioned, yields on product being produced today is now back to the levels we saw pre-COVID. So we expect that, that issue is now behind us.

現在來看看數字。 2022 年第四季度的收入約為 820 萬美元，比 2021 年第四季度增長 30%，在我們今年 1 月 5 日提供的 810 萬至 840 萬美元的初步範圍內。全年收入為 2780 萬美元，比 2021 年全年增長 55%。這一同比增長是由我們所有 3 項核心業務（OGM、Bionano Labs 和軟件）以及所有 3 項業務的強勁表現推動的主要地區。 2022 年第四季度毛利率為 22%，而 2021 年第四季度為 4%。全年毛利率為 21%，而 2021 年為 22%。與 2021 年相比略有下降主要是由於收益率我們從 2021 年底開始遇到的挑戰。正如 Erik 提到的，今天生產的產品的產量現在已經回到了 COVID 之前的水平。所以我們預計，這個問題現在已經過去了。

Regarding operating expense, we report both GAAP and non-GAAP numbers. We believe that providing our operating expense, excluding certain ongoing noncash expenses and other onetime expenses provides a more useful measure of our performance. Fourth quarter 2022 GAAP operating expense was $39.3 million compared to $29 million in the prior year. Full year 2022 GAAP operating expense was $137.6 million compared to $81 million in 2021. The increase for the quarter and the year was primarily due to increased headcount and headcount-related expenses and an increase in marketing and R&D expense.

關於運營費用，我們報告了 GAAP 和非 GAAP 數據。我們認為，提供我們的運營費用（不包括某些持續的非現金費用和其他一次性費用）可以為我們的業績提供更有用的衡量標準。 2022 年第四季度 GAAP 運營費用為 3930 萬美元，而去年同期為 2900 萬美元。 2022 年全年 GAAP 運營費用為 1.376 億美元，而 2021 年為 8100 萬美元。本季度和年度的增長主要是由於員工人數和員工人數相關費用的增加以及營銷和研發費用的增加。

Full year 2022 non-GAAP operating expense was $107.7 million and excludes $22.4 million in stock-based compensation, $5.8 million in amortization of intangibles and $1.8 million in acquisition-related transaction costs. Fourth quarter non-GAAP operating expense was $30.6 million compared to $21.8 million in the fourth quarter 1. Fourth quarter non-GAAP operating expense excludes $5.5 million in stock-based comp, $1.5 million in amortization of intangibles and $1.7 million in expenses related to our acquisition of Purigen.

2022 年全年非 GAAP 運營費用為 1.077 億美元，不包括 2240 萬美元的股票薪酬、580 萬美元的無形資產攤銷和 180 萬美元的收購相關交易成本。第四季度非 GAAP 運營費用為 3060 萬美元，而第四季度為 2180 萬美元 1. 第四季度非 GAAP 運營費用不包括 550 萬美元的股票補償、150 萬美元的無形資產攤銷和 170 萬美元的與我們相關的費用收購 Purigen。

We ended the fourth quarter with $113.2 million in cash, cash equivalents and available for sale securities compared to $180 million at the end of Q3. During the quarter, we incurred cost of approximately $34 million related to the Purigen acquisition, and we increased our safety stock of inventory by about $4.7 million to ensure supply to our customers. We have been and will continue to be proactive and opportunistic in terms of raising additional capital in order to position the company to capitalize on the promise of OGM.

第四季度末，我們擁有 1.132 億美元現金、現金等價物和可供出售證券，而第三季度末為 1.8 億美元。本季度，我們因收購 Purigen 而產生了約 3,400 萬美元的成本，我們將庫存安全庫存增加了約 470 萬美元，以確保向客戶供應。我們一直並將繼續在籌集額外資金方面積極主動和機會主義，以使公司能夠利用 OGM 的承諾。

Since the start of the year -- of this year, we've been active on our ATM facility, raising $14.8 million so far in Q1 of 2023. This morning, we filed an amendment to our current S3 placing a cap on the total amount of capital that can be raised under our existing shell to $400 million, of which $200 million can be raised under the ATM. This is a reduction to the $350 million -- $350 million under our previous ATM agreement. Tomorrow, we will file a new S3 with the same capital limits that will replace our current S3 once declared effective by the SEC.

自今年年初以來——今年以來，我們一直活躍於我們的 ATM 設施，到目前為止，在 2023 年第一季度籌集了 1480 萬美元。今天早上，我們提交了對當前 S3 的修正案，對總額設置了上限在我們現有的外殼下可以籌集到 4 億美元的資金，其中 2 億美元可以在 ATM 下籌集。根據我們之前的 ATM 協議，這減少了 3.5 億美元 - 3.5 億美元。明天，我們將提交具有相同資本限制的新 S3，一旦 SEC 宣布生效，它將取代我們當前的 S3。

Looking forward, as we begin 2023, we expect Q1 2023 revenues to be in the range of $7 million to $7.5 million, in line with the typical seasonal softness that we see in Q1. We expect full year 2023 revenue to be in the range of $35 million to $38 million, which at the midpoint would be 31% growth over 2022 revenue. I'm really pleased about the progress we're making across all aspects of the business and very excited about where we're headed. With that, I'm going to turn the call back to Erik to discuss our anticipated business plans before we take your questions. Erik?

展望未來，從 2023 年開始，我們預計 2023 年第一季度的收入將在 700 萬至 750 萬美元之間，這與我們在第一季度看到的典型季節性疲軟情況一致。我們預計 2023 年全年收入將在 3500 萬至 3800 萬美元之間，中值比 2022 年收入增長 31%。我對我們在業務的各個方面取得的進展感到非常高興，並對我們的發展方向感到非常興奮。有了這個，我將把電話轉回給埃里克，在我們回答你的問題之前討論我們預期的商業計劃。埃里克？

Thanks, Chris. Congratulations on the incredible results. I'd like to close out today by diving into the 2023 milestones that will be tied to our growth strategy. Before doing that, I want to remind everyone that we held our first-ever Strategy Day at NASDAQ in New York, where this whole team went through an in-depth review of our strategy, growth drivers, financial objectives, key initiatives related to clinical trials and new product advancements as well as in-depth discussions with 6 current users of the Saphyr system who are regarded as world leaders in their fields who gave incredible testimonials about the utility of that platform and its positioning.

謝謝，克里斯。祝賀取得令人難以置信的結果。我想在今天結束時深入探討與我們的增長戰略相關的 2023 年里程碑。在此之前，我想提醒大家，我們在紐約納斯達克舉辦了有史以來的第一次戰略日，整個團隊在會上對我們的戰略、增長驅動因素、財務目標、與臨床相關的關鍵舉措進行了深入審查試用和新產品改進，以及與 Saphyr 系統的 6 個當前用戶進行深入討論，這些用戶被認為是各自領域的世界領導者，他們對該平台的實用性和定位給出了令人難以置信的證明。

And so I encourage everyone to check out the recording of the event, which can be accessed on the investor side of our web page. As we reviewed in depth during Strategy Day, we're focused on driving what we believe is a cytogenetics revolution. ELEVATE! is our growth strategy. ELEVATE! is based on 6 strategic pillars. The first one is to expand commercial traction and validation of optical genome mapping and really all of our solutions to delight customers with robust products, clear the path for OGM reimbursement in our target markets continue to advance the product to enable further penetration of our existing markets as well as expand the market for penetration into new ones, make software a strategic driver of Bionano solutions.

因此，我鼓勵大家查看活動記錄，可以在我們網頁的投資者端訪問。正如我們在戰略日期間深入回顧的那樣，我們專注於推動我們認為是一場細胞遺傳學革命。提升！是我們的增長戰略。提升！基於 6 個戰略支柱。第一個是擴大光學基因組作圖的商業吸引力和驗證，實際上我們所有的解決方案都以強大的產品取悅客戶，為我們目標市場的 OGM 報銷掃清道路繼續推進產品以進一步滲透我們現有的市場以及擴大滲透到新市場的市場，使軟件成為 Bionano 解決方案的戰略驅動力。

And with the acquisition of Purigen Biosystems, we'll extend that to include making sample prep solutions for DNA isolation, another strategic driver. And then finally, the sixth pillar and one that's really important on a go-forward basis is that we need to execute these pillars with operations and strategies that will scale with this growing business. And so we have a number of key milestones that are planned in 2023. They cover areas of product development, our ongoing clinical studies milestones and reimbursement, milestones around expanding the base -- installed base of optical genome mapping systems and important regulatory developments with the FDA.

隨著對 Purigen Biosystems 的收購，我們將擴展到包括為 DNA 分離製作樣本準備解決方案，這是另一個戰略驅動因素。最後，第六個支柱和一個在前進的基礎上非常重要的支柱是，我們需要通過將隨著這一不斷增長的業務擴展的運營和戰略來執行這些支柱。因此，我們計劃在 2023 年實現一些關鍵里程碑。它們涵蓋產品開發領域、我們正在進行的臨床研究里程碑和報銷、圍繞擴大基礎的里程碑——光學基因組作圖系統的安裝基礎以及重要的監管發展食品藥品監督管理局。

I want to run through a few of these, and you'll be able to review them through the recording of this call, which will be archived on our website, but we intend to expand the OGM system installed base to 325 systems by the end of 2023. We intend to add to our menu of LDTs at Bionano Labs with one for whole genome evaluation of structural variations in constitutional genetic disease. We're going to be inspected by the College of American Pathologists at Bionano Laboratories in connection with our application for accreditation by CAP.

我想介紹其中的一些，您可以通過本次通話的錄音來查看它們，該通話將存檔在我們的網站上，但我們打算到年底將 OGM 系統的安裝基數擴展到 325 個系統2023 年。我們打算在 Bionano 實驗室的 LDT 菜單中添加一個，用於對體質性遺傳病的結構變異進行全基因組評估。美國病理學家協會將在 Bionano 實驗室接受 CAP 認證申請的檢查。

In the first half of 2023, we'll be launching the high-throughput Saphyr system, which we believe will increase throughput substantially and will be connected to the new Saphyr compute, which has been developed in collaboration with NVIDIA. We're going to have important pre-submission discussions with the FDA that are leading up to a pre-submission in connection with the high-throughput Saphyr system later on. We plan to submit an important dossier to Medicare for something called a local coverage decision in 2023. And we will advance our clinical studies.

2023 年上半年，我們將推出高吞吐量 Saphyr 系統，我們相信該系統將大幅提高吞吐量，並將連接到與 NVIDIA 合作開發的新 Saphyr 計算。我們將與 FDA 進行重要的預提交討論，這將導致稍後與高通量 Saphyr 系統相關的預提交。我們計劃在 2023 年向 Medicare 提交一份重要檔案，用於所謂的本地覆蓋決定。我們將推進我們的臨床研究。

There are a number of milestones in connection to these studies, including ongoing enrollment of our prenatal study as well as ongoing enrollment of the heme study around which we expect to achieve about 50% enrollment. We are continuing to pursue our Category 1 CPT codes for heme and constitutional use of optical genome mapping. And we expect to have pre-commercial versions at a minimum of our OGM kits for isotachophoresis that will run on the Ionic Purification System in the field by the end of the year.

有許多與這些研究相關的里程碑，包括正在進行的產前研究招募以及正在進行的血紅素研究招募，我們預計將實現約 50% 的招募。我們將繼續追求我們的 1 類 CPT 代碼，用於光學基因組作圖的血紅素和憲法用途。我們希望至少在我們用於等速電泳的 OGM 套件中有預商業版本，這些版本將在年底前在現場的離子淨化系統上運行。

And lastly, we will be launching and having a full commercial release of VIA, which is the newly named software for data analysis based on what we acquired from BioDiscovery and VIA includes the ability for optical genome mapping analysis and it will target heme applications in the first half of 2023 and then a whole genome analysis version available in the second half of the year. And so these are incredibly important milestones that we expect to achieve this year and the whole driver behind them is to provide catalysts that will enable ongoing revenue growth and the development of a very robust P&L.

最後，我們將發布並發布完整的 VIA 商業版本，這是基於我們從 BioDiscovery 獲得的數據新命名的軟件，VIA 包括光學基因組作圖分析的能力，它將針對血紅素在2023 年上半年，然後在下半年提供全基因組分析版本。因此，這些是我們預計今年要實現的非常重要的里程碑，它們背後的整個驅動力是提供催化劑，以實現持續的收入增長和非常強勁的損益表的發展。

And so as we continue to execute on these core elements of the strategy, we expect to grow revenue for the next few years at a healthy compound annual growth rate ranging from 30% to 50% through 2025. We believe that we're building a business that will eventually scale into this enormous market opportunity that we're pursuing and deliver exceptional financial results. And so in closing, I want to say that we are really excited about what we can achieve this year and we look forward to updating you soon about the first quarter and throughout the year going forward.

因此，隨著我們繼續執行該戰略的這些核心要素，我們預計到 2025 年，未來幾年的收入將以 30% 至 50% 的健康復合年增長率增長。我們相信我們正在建立一個最終將抓住我們正在追求的這個巨大市場機會的業務，並提供卓越的財務業績。因此，最後，我想說的是，我們對今年能夠取得的成就感到非常興奮，我們期待盡快向您介紹第一季度和全年的最新情況。

With that, Michelle, we are ready to take questions.

有了這個，米歇爾，我們準備好提問了。

(Operator Instructions) Our first question comes from the line of Jeffrey Cohen with Ladenburg.

（操作員說明）我們的第一個問題來自 Jeffrey Cohen 和 Ladenburg 的對話。

So I guess first, just a quick one for Chris. As far as the inventory and inventory build from Q4, you did call out a couple of things. Was that -- is there some relationship there to your new high-throughput instrument or was the buildup with flow cells or existing Saphyr instruments?

所以我想首先，Chris 的快速發言。至於第四季度的庫存和庫存構建，你確實提到了幾件事。那是——與您的新高通量儀器有某種關係，還是與流動池或現有 Saphyr 儀器的積累？

It was existing Saphyrs and flow cells. And basically, when -- in the height of the supply chain challenges, we wanted to ensure that we wouldn't be constrained on demand. So we started building safety stock. And I guess the key point is we're just about done with that in Q4, a little bit in Q1, and then we'll start bringing that safety stock down as we bring up the new instrument and consumables later in the year and into next year.

它是現有的 Saphyrs 和流通池。基本上，在供應鏈挑戰最嚴重的時候，我們希望確保我們不會受到需求的限制。所以我們開始建立安全庫存。我想關鍵是我們在第四季度剛剛完成，在第一季度完成了一點，然後我們將在今年晚些時候推出新儀器和消耗品時開始降低安全庫存，並進入明年。

Okay. Got it. That's helpful. So it's not necessarily going to increase along with your revenues, but it may have peaked for the shorter term.

好的。知道了。這很有幫助。所以它不一定會隨著你的收入而增加，但它可能在短期內達到頂峰。

Correct.

正確的。

Okay. Got it. And Erik, you do call out the 2 LDTs thus far? Would you expect others to be introduced during 2023 as well?

好的。知道了。埃里克，到目前為止，你確實召集了 2 個 LDTs 嗎？您是否希望其他人也能在 2023 年推出？

Yes. We're going to continue building that menu. So in 2023, for sure, we're going to release an LDT for constitutional genetic disorders that's looking at the whole genome and revealing structural variations that may be connected to a variety of indications such as intellectual disability, developmental delay and so forth.

是的。我們將繼續構建該菜單。所以在 2023 年，我們肯定會發布針對體質性遺傳病的 LDT，它會查看整個基因組並揭示可能與智力障礙、發育遲緩等各種適應症相關的結構變異。

Got it. And then as far as the new instrument introduction in the first half this year, do you expect that will replace Saphyrs at high throughput facilities and centers or would it be adjunct at high throughput centers?

知道了。然後就今年上半年推出的新儀器而言，您預計它會在高通量設施和中心取代 Saphyrs 還是會在高通量中心附屬？

I believe it's going to be incremental adjunct because the Saphyr system operates well and performs just as well as its high throughput version will, but it can be used in a setting like that for the development of new assays and other techniques that a laboratory or a customer may want to work on or evaluate. And so I really do expect that to be that the new system would be adjunctive to what they already have.

我相信這將是增量輔助，因為 Saphyr 系統運行良好，性能與其高通量版本一樣好，但它可以用於開發實驗室或實驗室無法進行的新檢測和其他技術的環境中客戶可能想要處理或評估。因此，我確實希望新系統能夠附加到他們已有的系統上。

Got it. And then lastly, one more, if I may. As far as the margins and looking forward into '23, would you expect that they grow from '22 levels? And if so, where are the levers, is it on the product side or the service and other side?

知道了。最後，如果可以的話，再來一個。就利潤率和展望 23 年而言，您會期望它們從 22 年的水平增長嗎？如果是這樣，槓桿在哪裡，是在產品方面還是在服務和其他方面？

So we do expect it to trend up from here. We're not providing any more guidance on exactly how much. But the reason is that we've now worked through the inventory of chips that were produced during the time when we were struggling with our yields. And so we built up a lot of inventory during that time again to make sure that we can service our customers. As Erik mentioned, thankfully, we didn't miss any deliveries to any of our customers, but we did that by virtue of having this inventory. So we've now worked through that, and we're back to production at kind of the yield levels that we were at prior to early 2020. So that's what's really going to drive it up.

所以我們確實預計它會從這裡開始上升。我們沒有提供更多關於確切數量的指導。但原因是，我們現在已經清點了在我們為提高產量而苦苦掙扎期間生產的芯片庫存。因此，我們在那段時間再次建立了大量庫存，以確保我們能夠為客戶提供服務。正如 Erik 所提到的，值得慶幸的是，我們沒有錯過任何客戶的交貨，但我們做到了這一點是因為有這個庫存。所以我們現在已經解決了這個問題，我們回到了 2020 年初之前的產量水平的生產。所以這才是真正要推動它的東西。

And one more quick one for Erik. As far as the payer environment, both the payers and Medicare, what's your sense around their receptiveness more recently to the overwhelming body of data that you're delivering to them? And how they're thinking about the economics in the space now?

給埃里克再寫一篇。至於付款人環境，包括付款人和醫療保險，您對他們最近對您提供給他們的大量數據的接受度有何看法？他們現在如何看待該領域的經濟學？

I think that the progress that we're seeing is very positive. And we have a function in the company, market access, led by a real veteran in the industry. And she's in the process of putting these data in front of these payers. And so while you and I follow Bionano's communications and press releases and publications, incredibly closely. The payers are still catching up. And so Dana is going to make it an issue for them and put it in front of them. But we have a lot of discussions ongoing already and payers get it. There's just a process that we have to go through to satisfy them. And Dana is developing a multipronged strategy, and we'll be able to say more about that in the future as we start delivering against some of these key milestones. But I think the fundamental answer is that they like what they see, and we have to make sure that all of them see it and then continue to see more and more and more and more.

我認為我們看到的進展是非常積極的。我們在公司中有一個職能，即市場准入，由一位真正的行業資深人士領導。她正在將這些數據放在這些付款人面前。因此，當你和我關注 Bionano 的通訊、新聞稿和出版物時，非常密切。付款人仍在追趕。因此，Dana 將把它作為一個問題擺在他們面前。但是我們已經進行了很多討論，付款人也明白了。我們必須經歷一個過程才能滿足他們。 Dana 正在製定一項多管齊下的戰略，在我們開始實現其中一些關鍵里程碑時，我們將能夠在未來更多地談論這一點。但我認為根本的答案是他們喜歡他們所看到的，我們必須確保他們所有人都看到它，然後繼續看到越來越多。

Our next question comes from the line of Sung Ji Nam with Scotiabank.

我們的下一個問題來自豐業銀行的 Sung Ji Nam。

So I was wondering about the completion of the postnatal study and the publication there, kind of what are the next steps? Is this something where you kind of wait for all the other studies to be completed in terms of beginning of your conversations with the guideline bodies or whatnot? Or just kind of curious what the next steps might be.

所以我想知道產後研究的完成和那裡的發表，接下來的步驟是什麼？就開始與指南機構或諸如此類的對話而言，這是您等待所有其他研究完成的地方嗎？或者只是好奇下一步可能是什麼。

I think that the principal next step is to finalize the preprint, which has been published and then submit it for a peer-reviewed publication. I think that that's the key next step for that body of data. But there are some 1,047 data sets associated with this study, and they all contain within multiple publications that will be able to dive deeply into and highlight some of the key endpoints that we've been seeking to measure, the preprint goes into a couple of subpopulations, one with autism spectrum disorder, another which was a prospective cohort that was collected, and it already shows almost an increase of 20% in pathogenic findings compared to the standard of care for both of those populations.

我認為下一步的主要工作是完成已經發表的預印本，然後將其提交給同行評審的出版物。我認為這是該數據體的關鍵下一步。但是有大約 1,047 個數據集與這項研究相關，它們都包含在多個出版物中，這些出版物將能夠深入研究並突出我們一直在尋求衡量的一些關鍵終點，預印本分為幾個亞群，一個患有自閉症譜系障礙，另一個是收集的前瞻性隊列，與這兩個人群的護理標準相比，它已經顯示致病發現增加了近 20%。

But it also reveals that there were a substantial number of presumably reportable findings that have a high likelihood of being pathogenic. And so we need to sort that out by looking deeply into the nature of those events. And so I think the way to think about it is that this preprint has been published, and we'll get that out. It's going to cover 1,047 data sets, which is an incredibly impactful number that nobody can run from. We show 100% concordance with the standard of care and substantial increase in performance overall.

但它也表明，有大量可能是可報告的發現很可能是致病的。因此，我們需要通過深入研究這些事件的性質來解決這個問題。所以我認為考慮它的方式是這個預印本已經發布，我們會把它拿出來。它將涵蓋 1,047 個數據集，這是一個非常有影響力的數字，沒有人可以逃避。我們顯示 100% 符合護理標準，並且整體績效顯著提高。

So it's very powerful, but there are many, many more publications that will dig out of that data set and proliferate. And so you should expect there to be just more and more information coming out, highlighting the incredible importance of optical genome mapping and those publications will support our efforts to convince guideline agencies, medical societies, to embrace optical genome mapping right things like consensus statements that ultimately result in the medical societies recommending optical genome mapping as first-line testing.

所以它非常強大，但是還有更多的出版物會挖掘出該數據集並激增。因此，您應該期望會出現越來越多的信息，強調光學基因組作圖的難以置信的重要性，這些出版物將支持我們努力說服指導機構、醫學協會接受光學基因組作圖正確的事情，例如共識聲明最終導致醫學會推薦光學基因組作圖作為一線測試。

Got you. That's super helpful. And then just curious about the HRD detection publication that came out. Obviously, very interesting there. Is that something that you could -- you might be able to incorporate into your solid tumor studies? Or is that just kind of something that you think the customers will continue to potentially develop on their own?

明白了這非常有幫助。然後只是對出現的 HRD 檢測出版物感到好奇。顯然，那裡非常有趣。這是你可以做的——你可以將其納入你的實體瘤研究嗎？還是您認為客戶可能會繼續自行開發這種東西？

We -- so Bionano is a player in HRD at 2 levels. Number one, we have what we believe is the most robustly performing approach to calling HRD and scoring HRD from existing data types like sequencing, next-generation sequencing and other data types, microarrays. And that's commercially available now and labs are adopting it and utilizing it. In addition, optical genome mapping has now been shown to be as good as sequencing, if not substantially better.

我們——所以 Bionano 是 HRD 的 2 個級別的參與者。第一，我們擁有我們認為最強大的方法來調用 HRD 並從現有數據類型（如測序、下一代測序和其他數據類型、微陣列）中對 HRD 進行評分。現在已經可以買到，實驗室正在採用和利用它。此外，光學基因組作圖現在已被證明與測序一樣好，如果不是更好的話。

There was a paper and maybe this is the one that you're referring to that was published from the Curie Institute in Paris. And it showed that optical genome mapping way outperformed whole genome sequencing for identifying patients in the study who were, in fact, qualified for PARP inhibitors. But if they only use sequencing to pick up those patients, they wouldn't have picked up as many. And so optical genome mapping appears to be more powerful.

有一篇論文，也許這就是您所指的那篇論文，它是由巴黎的居里研究所發表的。並且它表明，光學基因組作圖方法優於全基因組測序，可以識別研究中實際上有資格使用 PARP 抑製劑的患者。但如果他們只使用測序來挑選那些患者，他們就不會挑選那麼多。因此，光學基因組作圖似乎更強大。

And so that's a long way of saying, yes, we expect optical genome mapping to feature prominently in HRD scoring and that, that will be something that we will measure as part of these studies. Now I've got to be fair and point out that the vast majority of solid tumor specimens that are collected and analyzed throughout oncology today are in formalin-fixed paraffin-embedded tissue. And that's not something that we have an assay for optical genome mapping on yet. We expect to be able to work on that eventually using isotachophoresis.

所以這是一個很長的說法，是的，我們希望光學基因組作圖在 HRD 評分中具有顯著特徵，並且這將是我們將作為這些研究的一部分進行測量的東西。現在我必須公平地指出，今天在整個腫瘤學中收集和分析的絕大多數實體瘤標本都在福爾馬林固定石蠟包埋的組織中。我們還沒有對光學基因組作圖進行分析。我們希望能夠最終使用等速電泳來解決這個問題。

But what I can tell you is that the results that Curie is getting are so incredibly impactful that their institution is now advocating the collection of and preservation of frozen fresh tissue in breast cancer because it seems that optical genome mapping is so powerful that it warrants a change in practice of sample collection and sample utilization. And so maybe that's something that can influence -- be an influence on practices here in the United States.

但我可以告訴你的是，居里獲得的結果影響如此之大，以至於他們的機構現在提倡收集和保存乳腺癌的冷凍新鮮組織，因為光學基因組作圖似乎非常強大，值得樣本收集和样本利用實踐的改變。因此，也許這是可以影響的東西——對美國這裡的做法產生影響。

Great. And then lastly from me, on your 2023 guidance, for the 325 OGM system guidance, I was wondering if that's including the new high throughput systems. And also, are you seeing maybe some of your potential customers or existing customers kind of waiting or holding off in terms of adopting OGM systems in the -- currently or in the first half of the year in anticipation of the launch in the second half of the year.

偉大的。最後，關於你的 2023 年指南，關於 325 OGM 系統指南，我想知道這是否包括新的高吞吐量系統。而且，您是否看到您的一些潛在客戶或現有客戶在目前或上半年採用 OGM 系統方面正在等待或推遲，以期在下半年推出那一年。

We don't see that. And the availability of this new high throughput system will be relatively limited in the second half of this year, and that's somewhat by design to protect against any hesitation in the market. We also will have different commercial terms, and we'll continue to make it very attractive to bring Saphyr in and adopt and get up and running with it. Whereas the commitment for the high throughput system will be a little bit higher. So we're working on ways in which we can really engineer the demand and make sure that there isn't a pause.

我們看不到這一點。而這種新的高通量系統的可用性在今年下半年將相對有限，這在某種程度上是為了防止市場出現任何猶豫而設計的。我們也將有不同的商業條款，我們將繼續使其非常有吸引力，將 Saphyr 引入並採用並啟動並運行它。而高吞吐量系統的承諾會高一點。因此，我們正在研究可以真正設計需求並確保沒有停頓的方法。

Having said that, I'm sure that there will be some sites that will be go ahead and wait on the sidelines. We know that there are sites that are waiting on the sidelines today, but we're not thinking that it's going to pause substantially existing opportunities in the sales pipeline. But we have to see there is that risk. And with regard to the first question, the 325 is inclusive of both Saphyr systems and the new high-throughput system.

話雖如此，我確信會有一些網站繼續進行並在場邊等待。我們知道今天有些網站在觀望，但我們認為這不會暫停銷售渠道中現有的大量機會。但我們必須看到存在這種風險。關於第一個問題，325 包括 Saphyr 系統和新的高通量系統。

Our next question comes from the line of Jason McCarthy with Maxim Group.

我們的下一個問題來自 Maxim Group 的 Jason McCarthy。

This is Michael Okunewitch on the line for Jason. And I want to congratulate you on the fantastic progress not just over this most recent quarter, but really over 2022 overall.

我是 Michael Okunewitch 接聽 Jason 的電話。我要祝賀您不僅在最近一個季度取得了驚人的進步，而且在整個 2022 年取得了巨大進步。

Thanks, Michael. That's great love it. I appreciate it.

謝謝，邁克爾。那真是太喜歡了。我很感激。

So I actually wanted to ask a follow-up question on the publication that you just released recently from the postnatal study. There were 2 real key takeaways. Obviously, you had the high technical performance, and that's key, but there was also a 30% to 40% increase in diagnostic yields in some of those data sets. So could you talk a little bit about how the -- how both payers and guidelines sign importance to demonstrating full concordance within a simplified and streamlined workflow versus the increases in diagnostic yield.

所以我其實想問一個關於你最近發布的產後研究出版物的後續問題。有 2 個真正的關鍵要點。顯然，您擁有高技術性能，這是關鍵，但其中一些數據集的診斷率也提高了 30% 到 40%。那麼，您能否談一談付款人和指南如何在簡化和流線型的工作流程中證明完全一致性與診斷率增加的重要性。

Well, I think that it's obviously the name of the game. That's what we're aiming for. We believe that we would be seeing these kinds of outcomes and we went for it or I should say that Alka Chaubey, our Chief Medical Officer, believed it so strongly that she left PerkinElmer to come here and make these things happen. And she's been right on target.

好吧，我認為這顯然是遊戲的名稱。這就是我們的目標。我們相信我們會看到這些結果，我們為此而努力，或者我應該說，我們的首席醫療官 Alka Chaubey 堅信這一點，以至於她離開 PerkinElmer 來到這裡，讓這些事情發生。她一直是正確的目標。

And when it comes to talking about pontificating, if you will, on how medical societies and payers and so forth will respond. Of course, it's speculation, we don't know. But we have history to look at. Karyotyping was once the recommended first-line method of analysis in constitutional genetic testing. And it's overall diagnostic yield was pretty poor, low single digits. And microarrays offered the same kind of concordance that we're seeing with optical genome mapping relative to the standard of care, but an incremental improvement.

如果你願意的話，當談到談論武斷時，醫學協會和付款人等將如何回應。當然，這是猜測，我們不得而知。但我們有歷史要看。核型分析曾經是體質基因檢測中推薦的一線分析方法。而且它的整體診斷率很差，低個位數。微陣列提供了我們在光學基因組圖譜中看到的與護理標準相關的一致性，但是是漸進式改進。

And if you look at the performance of microarrays, it's anywhere between 10% and 20% or so diagnostic yield on average across all labs that are performing it. And so when we are -- when microarray studies were conducted and this increase in diagnostic yield was reported, we saw the medical societies and payers come on board enthusiastically and make recommendations for microarrays to be considered as the first-line test, and that's how those guidelines are written on a global basis.

如果你看一下微陣列的性能，它在所有執行微陣列的實驗室中平均診斷率在 10% 到 20% 左右。因此，當我們 - 當進行微陣列研究並報告診斷率增加時，我們看到醫學協會和付款人熱情地加入並提出將微陣列視為一線測試的建議，這就是如何這些準則是在全球範圍內製定的。

And so when we bring the level of performance against the standard of care, so now we're 100% concordant, not karyotyping, but to the newly increased standard set by microarrays and karyotyping combined. And by the way, in many cases, in constitutional genetic disorders, it was additional modalities were used as well. Fish, Southern blot -- and so we compare it against the whole kitchen sink that's available today, 100% concordance. And then when you look at this incremental performance, it's really outstanding. So we feel like the medical community would see this as an incredible advancement in the performance alone.

因此，當我們將性能水平與護理標准進行對比時，現在我們是 100% 一致的，不是核型分析，而是通過微陣列和核型分析相結合的新增加的標準。順便說一句，在許多情況下，在體質性遺傳疾病中，還使用了其他方式。魚、Southern blot——所以我們將它與今天可用的整個廚房水槽進行比較，100% 一致性。然後，當您查看這種增量性能時，它確實非常出色。因此，我們認為醫學界會認為這是一項令人難以置信的性能進步。

But then when you add as you did, the fact that it's coming from a single assay, which shrinks the time to results, which is incredibly impactful for these families who are waiting to hear the answers we think it's kind of very clear the path forward in this case. The work remains, though, to continue the studies, to continue the analysis, to drive the publications and to get this in front of these societies. We have a little bit of a head start because many of the PIs on this study are involved in these societies. And so they're certainly aware, but it's incredible results. And I think it's just the beginning.

但是當你像你所做的那樣添加時，事實是它來自一個單一的化驗，這縮短了獲得結果的時間，這對這些等待聽到答案的家庭產生了難以置信的影響，我們認為這是非常明確的前進道路在這種情況下。然而，工作仍然是繼續研究、繼續分析、推動出版物並將其呈現在這些社會面前。我們有一點領先，因為這項研究的許多 PI 都參與了這些社會。所以他們當然知道，但這是令人難以置信的結果。我認為這僅僅是個開始。

All right. Yes. Thank you so much for that. I also want to touch on NXClinical 7.0 now that, that's out in the field. Have you gotten any feedback from the early adopters on that new software solution?

好的。是的。對此感激不盡。現在我還想談談 NXClinical 7.0，它已經在現場了。您是否從早期採用者那裡獲得了有關該新軟件解決方案的任何反饋？

We have. They're enthusiastic about it. And -- they love our current systems, which is great because I think our team has worked for years in developing analytical platforms for OGM data, and it's a brand-new data type and everybody was excited to develop methods for sequencing out in the world academically, but we were on our own with OGM and Mark Oldakowski, the leader of Product Development, Chief Operating Officer, assembled the team, and they built an incredibly powerful platform that's being utilized.

我們有。他們對此充滿熱情。而且——他們喜歡我們目前的系統，這很棒，因為我認為我們的團隊多年來一直致力於開發 OGM 數據的分析平台，這是一種全新的數據類型，每個人都對開發在世界上進行測序的方法感到興奮在學術上，但我們與 OGM 和產品開發負責人兼首席運營官 Mark Oldakowski 一起組建了團隊，他們構建了一個令人難以置信的強大平台，並得到了利用。

But there are elements of that platform that these KOLs and customers had been asking for around reporting. They want to look at a report that tells them whether a variant was detected or not detected. They want that report to be driven by the medical guidelines. This is a critical step in their workflow. They want to be able to immediately interpret the structural variation findings that they see either through Access or what we call VIA that's NXClinical 7.0, we shortened that name to VIA, which stands for Variant Intelligent Applications. So they're able to visualize it either way, Access or VIA, but the interpretation is something that we've now built into NXClinical for structural variations. And we're delivering these reports. These are incredibly powerful.

但是，這些 KOL 和客戶一直在圍繞報告要求該平台的某些元素。他們想查看一份報告，告訴他們是否檢測到變體。他們希望該報告由醫療指南驅動。這是他們工作流程中的關鍵步驟。他們希望能夠立即解釋他們通過 Access 或我們稱之為 NXClinical 7.0 的 VIA 看到的結構變異發現，我們將該名稱縮短為 VIA，代表變體智能應用程序。因此，他們能夠以任何一種方式對其進行可視化，Access 或 VIA，但解釋是我們現在已經內置到 NXClinical 中的結構變化。我們正在提供這些報告。這些功能非常強大。

Why are these reports important? Because, of course, they're customized and validated in customers' hands remember, this product is research use only, so customers have to select the panels that they want to have reported out. But once they select that, they're able to put these incredibly actionable reports in the hands of clinicians and oncologists can interpret them immediately. So it's incredibly powerful. And what they tell us is that they love this workflow and that it really simplifies their life incredibly because today, even with optical genome mapping and Access, it's an incredible power, they're having to deal with multiple different software platforms. And so this kind of advancement is something that they've been waiting for.

為什麼這些報告很重要？因為，當然，它們是在客戶手中定制和驗證的，請記住，該產品僅供研究使用，因此客戶必須選擇他們想要報告的面板。但一旦他們選擇了這一點，他們就能夠將這些令人難以置信的可操作報告交到臨床醫生手中，腫瘤學家可以立即對其進行解讀。所以它非常強大。他們告訴我們的是，他們喜歡這個工作流程，它確實極大地簡化了他們的生活，因為今天，即使有了光學基因組作圖和訪問，它也是一種不可思議的力量，他們不得不處理多個不同的軟件平台。因此，這種進步是他們一直在等待的。

And I want to underscore and it's the reason that making software a strategic driver of business for us is one of our pillars is that VIA is not only a solution for optical genome mapping, but it integrates these other data types. And when you look at the sequencing landscape out there and you see all of these companies that are introducing next-generation sequencing solutions. We have talked to them and we're enthusiastic about working with them. We all see them bringing value to the end user.

我想強調的是，讓軟件成為我們業務的戰略驅動力是我們的支柱之一的原因是 VIA 不僅是光學基因組作圖的解決方案，而且還集成了這些其他數據類型。當您審視測序領域時，您會看到所有這些公司都在推出下一代測序解決方案。我們已經與他們談過，我們熱衷於與他們合作。我們都看到它們為最終用戶帶來價值。

But what the end user sees is that they need a solution that integrates this information altogether for one-stop reporting and our VIA provides that. So we're only at the beginning of the power of this software. We believe software is going to be a strategic driver of our solutions and customer adoption going forward. So we're excited to roll out the full commercial release of the heme hematologic malignancy application in the first half of this year and really keep that ball rolling on an ongoing basis.

但最終用戶看到的是，他們需要一個將這些信息完全集成以進行一站式報告的解決方案，而我們的 VIA 提供了這一點。所以我們才剛剛開始發揮這個軟件的威力。我們相信軟件將成為我們解決方案和客戶採用的戰略驅動力。因此，我們很高興在今年上半年推出血紅素血液惡性腫瘤應用程序的完整商業版本，並真正讓這個球持續不斷地滾動。

Our next question comes from the line of François Brisebois with Oppenheimer.

我們的下一個問題來自 François Brisebois 與 Oppenheimer 的對話。

Dan on for Frank. Congrats on the quarter. Firstly, I just want to start with if you could add some color on the -- how the integration of the Purigen Ionic system has been going, have the development team and commercialization team all been completely onboarded. And in terms of the market, are you starting to see renewed interest from those customers where you are on the sidelines? And also related to that, how are you thinking about the additional markets you could expand into?

丹替弗蘭克上場。祝賀這個季度。首先，我只想從你是否可以添加一些顏色開始——Purigen Ionic 系統的集成是如何進行的，開發團隊和商業化團隊是否都已經完全加入。就市場而言，您是否開始看到那些處於觀望狀態的客戶重新產生興趣？與此相關的是，您如何考慮可以擴展到的其他市場？

Yes. Thanks, Dan. I appreciate the comments and great question. So with regard to the acquisition, integration is, to a certain degree, ongoing, but this one was very straightforward. We had an outstanding product, which we have integrated into our commercial teams in Europe and in the United States. And then our channel partners or distribution partners around the world are being onboarded to sell the Ionic system. And we think that as a stand-alone business, it has a lot of great potential it's going to take some time to really figure out how much of the market we can penetrate with it, but we know it's outstanding technology and that the current users love the system. We think we can multiply it.

是的。謝謝，丹。我很欣賞評論和很好的問題。因此，就收購而言，整合在某種程度上正在進行中，但這一次非常簡單。我們擁有出色的產品，我們已將其整合到我們在歐洲和美國的商業團隊中。然後，我們在世界各地的渠道合作夥伴或分銷合作夥伴開始銷售 Ionic 系統。我們認為，作為一個獨立的業務，它有很大的潛力，需要一些時間才能真正弄清楚我們可以用它滲透多少市場，但我們知道它是一項出色的技術，而且當前的用戶喜歡這個系統。我們認為我們可以乘以它。

But that team has been fully integrated under the sales leadership that we have in place and marketing leadership that we have in place. From a development perspective, that team is led by Klint Rose, who is the -- one of the co-founders of Purigen Biosystems and really one of the gurus of isotachophoresis. And what I can tell you is that Klint and his team are super fired up to be part of Bionano and if you want to learn something about isotachophoresis and its applications, I encourage everybody to look at the archived recording of our workshop at the Advances in Genome Biology Technology or AGBT meeting, which was held on February 6.

但是該團隊已經完全整合在我們現有的銷售領導和我們現有的營銷領導下。從開發的角度來看，該團隊由 Klint Rose 領導，他是 Purigen Biosystems 的聯合創始人之一，實際上是等速電泳的大師之一。我可以告訴你的是，Klint 和他的團隊非常熱衷於成為 Bionano 的一員，如果你想了解等速電泳及其應用，我鼓勵大家看看我們在 Advances in 上的研討會的存檔記錄基因組生物學技術或 AGBT 會議，於 2 月 6 日舉行。

And Klint gives a brilliant talk. And we're really pleased to have him on board here and his team as a stand-alone sample prep company was focused on developing solutions for the entire spectrum of samples that might need to be used in genome analysis. And that's great. That's exciting, but it includes a lot of things that are tough to work on. We have really taken and said, listen, let's focus on human genome analysis stuff that's highly relevant for clinical translational work. You've done an incredible job in formalin-fixed paraffin-embedded tissue, FFPE so far, keep doing that. But now let's start to work on the optical genome mapping workflow.

克林特發表了精彩的演講。我們真的很高興他加入這裡，他的團隊作為一家獨立的樣本製備公司，專注於為可能需要用於基因組分析的所有樣本開發解決方案。那太好了。這很令人興奮，但其中包含很多難以完成的事情。我們真的接受並說，聽著，讓我們專注於與臨床轉化工作高度相關的人類基因組分析。到目前為止，您在福爾馬林固定石蠟包埋組織、FFPE 方面做得非常出色，請繼續這樣做。但現在讓我們開始研究光學基因組作圖工作流程。

Initially, they're focused on blood, bone marrow, frozen tissue -- and that really complements what's currently available in the market in manual workflow. We want to automate that as quickly as possible using isotachophoresis, which will be a complement to what Hamilton has out in the field. But then we're going to expand the menu, as you say, start to go into new markets, looking at prenatal sample prep, all sorts of sample types that are very minute, such as punch biopsies and sample types that are very common in genetic disease, including buccal or cheek swabs where the cells of interest are present in a very dilute concentration.

最初，他們專注於血液、骨髓、冷凍組織——這確實補充了目前市場上可用的手動工作流程。我們希望使用等速電泳盡快實現自動化，這將是對 Hamilton 在該領域所做工作的補充。但隨後我們將擴展菜單，正如您所說，開始進入新市場，著眼於產前樣本準備，各種非常微小的樣本類型，例如穿孔活檢和在美國非常常見的樣本類型遺傳病，包括口腔或臉頰拭子，其中感興趣的細胞濃度非常低。

And so isotachophoresis looks to be the perfect solution to making those samples compatible with optical genome mapping and gives us the opportunity to penetrate these new markets within our kind of addressable TAM overall. And with regard to customers sitting on the sidelines, I think really, obviously, these new markets would represent an opportunity to bring new customers in. But the reality of it is that the degree to which anybody is waiting to adopt optical genome mapping, they're more waiting on us addressing their throughput needs in hematologic malignancies, which we already have supported sample prep solutions for and we'll be integrating onto ITP going forward and reimbursement.

因此，等速電泳看起來是使這些樣品與光學基因組作圖兼容的完美解決方案，並使我們有機會在我們的可尋址 TAM 中打入這些新市場。至於坐在場邊的客戶，我認為這些新市場顯然代表了一個吸引新客戶的機會。但現實是，任何人等待採用光學基因組作圖的程度，他們更多的人在等待我們解決他們在血液惡性腫瘤方面的吞吐量需求，我們已經為其提供了樣本製備解決方案支持，並且我們將整合到 ITP 中並進行報銷。

So ITP is key to advance the workflow and then bring in these new sample types to expand the workflow. But a lot of the customers that already have optical genome mapping will add isotachophoresis and their volume, their utilization volumes will grow as opposed to customers coming in from the sidelines.

因此 ITP 是推進工作流程然後引入這些新樣本類型以擴展工作流程的關鍵。但是許多已經擁有光學基因組作圖的客戶將增加等速電泳和他們的數量，他們的使用量將會增長，而不是來自旁觀者的客戶。

And just finally a quick one for me. You highlighted some COVID-related challenges at the start of the year. Are you now seeing production yield sort of normalized to pre-pandemic levels? Or is it more of a gradual return?

最後對我來說是一個快速的。您在年初強調了一些與 COVID 相關的挑戰。您現在是否看到產量已正常化到大流行前水平？還是更多的是逐漸回歸？

It was a gradual return that unfolded over the course of the year and the actual production yield, which had basically tanked in the fourth quarter of 2021, we've reached those levels. However, the impact of that reduced yield translated into the need to build more inventory because we just needed to recover more chips from -- as a result of the lower yield. And so the production of those chips came at a higher cost. And so we're burning through that inventory.

這是在一年中逐步恢復的過程，實際產量在 2021 年第四季度基本下降，我們已經達到了這些水平。然而，產量下降的影響轉化為需要建立更多庫存，因為我們只需要從產量較低的結果中回收更多芯片。因此，這些芯片的生產成本更高。所以我們正在燒掉那個庫存。

So the yield -- the production yield itself has been restored. We got to work hard to keep it there. There's no guarantee that it stays there, but we believe it's stabilized for now. But we need to work through the chips that were built at a higher cost overall. So it's going to take some time now for the margin to recover.

所以產量——生產產量本身已經恢復。我們必須努力工作才能讓它保持在那裡。不能保證它會留在那裡，但我們相信它現在已經穩定了。但我們需要研究整體成本更高的芯片。因此，利潤率現在需要一些時間才能恢復。

Our last question comes from the line of Mark Massaro with BTIG.

我們的最後一個問題來自 BTIG 的 Mark Massaro。

Congrats on a strong year and a nice Analyst Day in AGBT last month. I wanted to start off with the guidance. I saw your Q1 revenue guide of $7 million to $7.5 million. That's down 10% to 15% sequentially. Just wanted to make sure that it's largely just a function of seasonality. A lot of people may have exhausted budgets at the end of Q4. Do you think that Q1 will mark the low point of the year and that we can have likely an acceleration from the Q1 level?

祝賀上個月在 AGBT 取得了豐碩的一年和一個不錯的分析師日。我想從指導開始。我看到您的第一季度收入指南為 700 萬至 750 萬美元。這連續下降了 10% 到 15%。只是想確保它在很大程度上只是季節性的函數。很多人可能在第 4 季度末已經用盡了預算。您是否認為第一季度將標誌著今年的低點，並且我們可能會從第一季度水平加速？

That's certainly typically what we see, a combination of things just getting a slow start with new budgets in the beginning of the year. like you said, people are kind of rushing to spend the remaining capital budgets at the end of the prior year. So we always see this kind of this level of drop from Q4 to Q1. And then at least for the last 3 years, we've seen growth off of that Q1 number steadily throughout the year. And that's certainly what we expect to see again this year.

這當然是我們通常看到的情況，年初的新預算只是緩慢啟動的組合。就像你說的，人們有點急於花掉上一年年底剩餘的資本預算。所以我們總是看到從第四季度到第一季度的這種這種水平的下降。然後至少在過去 3 年裡，我們看到第一季度的數字在全年穩步增長。這當然是我們希望今年再次看到的。

Okay. Excellent. I noticed in your 10-K, I think you broke out the software revenue from the service and other line. And I think you noted that software revenue is expected to even out. Should we expect flattish software? And then when I think about the buckets, I think you grew instruments 46% in 2022. You grew consumables 16% in 2022. Is it likely that instruments will continue to outpace consumables in 2023? And maybe can you give us a sense for what type of contribution you might get from services? And again, I assume software is flattish, but any additional color there would be helpful.

好的。出色的。我注意到在你的 10-K 中，我認為你從服務和其他方面打破了軟件收入。我想你注意到軟件收入預計會持平。我們應該期待扁平化軟件嗎？然後當我想到水桶時，我認為你在 2022 年增長了 46% 的儀器。你在 2022 年增長了 16% 的消費品。儀器是否有可能在 2023 年繼續超過消費品？也許您可以讓我們了解您可以從服務中獲得什麼類型的貢獻？再一次，我認為軟件是扁平化的，但任何額外的顏色都會有所幫助。

Yes. So software, flattish is probably under-calling it a little bit. We'll see modest growth. The core economic engine of the company is OGM. And so that's where we'll see the bulk of the growth come from. But the software and services business both will -- are projected to be up from last year. Well, with the growth in the installed base, we should expect to continue to see growth in the consumables. And ultimately, the consumables will start to exceed the instrument revenue. That's certainly the goal and the expectation. So we'll see that consumable revenue grow as a percentage of total revenue.

是的。所以軟件，flattish 可能有點低估了它。我們將看到溫和的增長。公司的核心經濟引擎是OGM。因此，這就是我們將看到大部分增長的來源。但軟件和服務業務都將 - 預計將比去年有所增長。那麼，隨著安裝基數的增長，我們應該期望消耗品繼續增長。最終，耗材收入將開始超過儀器收入。這當然是目標和期望。因此，我們將看到消費品收入佔總收入的百分比增長。

I think keep in mind. Mark, I was going to say something to keep in mind is that the instrument revenues can be very lumpy. The deals tend to be pretty big in size. And we had pretty significant instrument purchases coming from certain geographical regions. And so we're going to see that for a little while where just a particular type of adoption is going to kind of skew the numbers a little bit. But Chris is right, which is that we're seeing the consumables growth on a year-over-year basis from a unit perspective, the growth of units is significant.

我想記住。馬克，我要說的是要記住的是，儀器收入可能非常不穩定。這些交易的規模往往很大。我們從某些地理區域購買了相當多的儀器。因此，我們將在一段時間內看到，只有一種特定類型的採用會稍微扭曲數字。但克里斯是對的，從單位的角度來看，我們看到消耗品同比增長，單位的增長是顯著的。

And so everything that we're seeing is pointing towards substantial growth on the consumables line. And I want to thank you for asking the question about the $7 million to $7.5 million guidance, that is, as Chris said, but I want to underscore it for you and for everybody that, that's typical seasonality. I think we were $5 million and change in the first quarter of 2022. So typical seasonality.

因此，我們所看到的一切都指向消耗品生產線的大幅增長。我要感謝你提出有關 700 萬至 750 萬美元指導的問題，正如克里斯所說，但我想向你和所有人強調，這是典型的季節性。我認為我們是 500 萬美元，並在 2022 年第一季度發生變化。典型的季節性。

All right. Perfect. And then I also wanted to ask about the next-gen Saphyr. I think at the Analyst Day, you mentioned a 13x increase in throughput capacity. If I have it right, the Saphyr list price is $150,000. Given the fact that this is higher throughput, can we assume maybe a higher list price? And I don't know if you can provide any specificity to that. And then as it relates to the cost per sample, I know that NGS has been dropping. I think you guys are at around $450 per sample. Can you give us a sense for where you think that might trend on a dollar basis exiting 2023 or 2024.

好的。完美的。然後我還想問一下下一代 Saphyr。我想在分析師日，您提到吞吐量增加了 13 倍。如果我沒記錯的話，Saphyr 的標價是 150,000 美元。鑑於這是更高的吞吐量，我們可以假設更高的標價嗎？我不知道你是否可以對此提供任何具體信息。然後因為它與每個樣本的成本有關，我知道 NGS 一直在下降。我想你們每個樣品的價格在 450 美元左右。您能否告訴我們您認為在 2023 年或 2024 年之後以美元為基礎的趨勢可能在哪裡？

So with regard to consumables pricing, I mean, in -- over the course of the year, I think that ASP and what we've seen historically for the last handful of quarters, 4 quarters, maybe 6 quarters is that we don't have a lot of pressure on price. The $450 is actually list price if you own a system. If you rent a system, it's a little bit higher. But we don't see a lot of pressure there. We know that as we expand geographically, if we want to get the business, we're probably going to have to lower price.

因此，關於消耗品定價，我的意思是，在這一年中，我認為 ASP 以及我們在過去幾個季度、4 個季度、也許 6 個季度中看到的歷史是我們沒有價格壓力很大。如果您擁有一個系統，則 450 美元實際上是標價。如果你租一個系統，它會高一點。但我們在那裡看不到很大的壓力。我們知道，隨著我們在地域上的擴張，如果我們想獲得業務，我們可能不得不降低價格。

And so a lot of our efforts around especially on the next-gen side, development of consumables is to drive costs of production down so that we have more flexibility around price. I see maybe some erosion of the $450 overall this year in 2023, but not a substantial amount. And it's healthy to imagine that going down over the subsequent years because of the price elasticity that exists out there. And we have said that we would expect to -- that it's kind of one of our goals to be able to -- if we had to, to produce our consumables in such a way that if we ever had to get down to sub $200 we could do it and have good margins. So -- but that's going to happen over time, and that's going to be driven by really, really substantial increases in volume.

因此，我們的很多努力，特別是在下一代方面，消耗品的開發是為了降低生產成本，以便我們在價格方面有更大的靈活性。我認為到 2023 年，今年 450 美元的整體價格可能會有所下降，但幅度不會很大。由於那裡存在的價格彈性，可以想像在隨後的幾年中會下降。我們已經說過，我們希望——這是我們的目標之一——如果必須的話，以這樣一種方式生產我們的消耗品，如果我們不得不降到 200 美元以下，我們可以做到並且有很好的利潤。所以——但這會隨著時間的推移而發生，而且這將受到真正、真正大幅增長的推動。

Now turning to your question about the high throughput Saphyr system, we haven't set pricing for it yet. We certainly think that the value is there. I want to emphasize one thing, and that is that yes, it's a 13-fold increase in throughput overall compared to Saphyr, but that goes step-wise. So on a per instrument basis, it's right around fourfold increase in throughput, but we have a scheme developed where we will leverage something called a work cell, which is very common in the industry and enables us to link together multiple systems. And so that's where we get that second phase of throughput increase that gets us to the 13x or so, maybe even higher. And so that work cell will be available in 2024.

現在轉向你關於高通量 Saphyr 系統的問題，我們還沒有為它設定定價。我們當然認為價值就在那裡。我想強調一件事，那就是，是的，與 Saphyr 相比，它的總體吞吐量增加了 13 倍，但這是逐步增加的。因此，在每台儀器的基礎上，吞吐量增加了大約四倍，但我們開發了一個方案，我們將利用稱為工作單元的東西，這在行業中很常見，使我們能夠將多個系統連接在一起。這就是我們獲得吞吐量增加的第二階段的地方，使我們達到 13 倍左右，甚至更高。因此，該工作單元將於 2024 年投入使用。

Now something that is an important lever that we are looking at with regard to the commercialization of this high throughput system is whether or not it's going to be available in the reagent rental program. And I think that it will probably be a more demanding rental program than we have put out there for the Saphyr. And so I think what might happen on average is that you're going to see more purchases for the high throughput system than you see for the Saphyr system. And so that would have the effect of driving up revenues. The cost of building that high throughput system will enable us to have acceptable margins at the $150,000 level.

現在，關於這種高通量系統的商業化，我們正在考慮的一個重要槓桿是它是否會在試劑租賃計劃中可用。而且我認為這可能比我們為 Saphyr 推出的租賃計劃要求更高。因此，我認為平均而言可能會發生的情況是，與 Saphyr 系統相比，高吞吐量系統的購買量會更多。因此，這將產生推高收入的效果。構建該高吞吐量系統的成本將使我們能夠在 150,000 美元的水平上獲得可接受的利潤。

Yes, makes sense. My last question is, can you expand a little bit on conversations you're having to obtain an LCD for OGM reimbursement? Is that with Palmetto MolDX or Noridian? And can you give us a sense for timing and perhaps what data you may need to submit?

是的，有道理。我的最後一個問題是，您能否詳細談談您必須獲得 LCD 以獲得 OGM 報銷的對話？是用 Palmetto MolDX 還是 Noridian？您能否告訴我們時間安排以及您可能需要提交哪些數據？

So those discussions have been ongoing with Palmetto for some time actually. We talked with them in -- certainly in early 2021 about laying the groundwork and something that they've been looking for is to see adoption of optical genome mapping and validation of laboratory developed tests by users in the field because they don't want to work on something that only the manufacturer cares about. So I respect that. And what we've seen now is a tremendous increase in the number of laboratory developed tests and importantly, in their jurisdiction, in Palmetto's jurisdiction. And so they're starting to see submissions for reimbursement in their regions.

所以這些討論實際上已經與 Palmetto 進行了一段時間。我們與他們進行了交談——當然是在 2021 年初，關於奠定基礎，他們一直在尋找的是看到採用光學基因組圖譜和驗證該領域用戶實驗室開發的測試，因為他們不想從事只有製造商關心的事情。所以我尊重這一點。我們現在看到的是實驗室開發的測試數量大幅增加，重要的是，在他們的管轄範圍內，在 Palmetto 的管轄範圍內。因此，他們開始看到他們所在地區的報銷申請。

And so -- our strategy is to be a facilitator in the market and work with Palmetto, the degree to which we're allowed as a manufacturer researchers-only platform in connection with users, but also with what's going on at Bionano Laboratories, our own CLIA lab. And we want to work with them and other MAX to establish local coverage decisions. And we're pursuing them all in parallel, I think you can say in principle -- there are some merits to going after Palmetto initially, but I think our view is that we need to be in conversations with all of them.

因此——我們的戰略是成為市場的促進者並與 Palmetto 合作，我們被允許作為製造商研究人員專用平台與用戶聯繫的程度，以及 Bionano Laboratories 正在發生的事情，我們的自己的 CLIA 實驗室。我們希望與他們和其他 MAX 一起制定本地覆蓋決策。我們正在同時追求它們，我想你可以原則上說——最初追求 Palmetto 有一些優點，但我認為我們的觀點是我們需要與所有這些人進行對話。

And Palmetto and MolDX have pretty clear requirements for information that needs to be submitted around things like clinical utility, clinical validity, analytical validity, things like limit of detection and other forms of performance that establish that optical genome mapping workflow is robust, it's reliable and it can be operated on a lab-to-lab basis. And so we've communicated with them we have that list, and we're working against it in developing a dossier that we'll be submitting to them sometime this year.

Palmetto 和 MolDX 對需要提交的信息有非常明確的要求，這些信息需要圍繞臨床實用性、臨床有效性、分析有效性、檢測限度和其他形式的性能來確定光學基因組作圖工作流程是穩健的、可靠的和它可以在實驗室到實驗室的基礎上運行。因此，我們已經與他們進行了溝通，我們有了這份清單，並且我們正在努力製定一份我們將在今年某個時候提交給他們的檔案。

And I would like to turn the conference back over to Dr. Erik Holmlin for any further remarks.

我想將會議轉回給 Erik Holmlin 博士作進一步評論。

Thank you, Michelle, and thank you to everyone for joining. Thanks to everyone who asked such an incredibly insightful and penetrating questions. We look forward to updating you on our progress on the first quarter 2023 call in short order. Thank you very much.

謝謝你，米歇爾，感謝大家的加入。感謝所有提出如此極具洞察力和洞察力的問題的人。我們期待盡快向您通報我們在 2023 年第一季度電話會議上的進展情況。非常感謝。

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day. Thanks.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。大家，祝你有美好的一天。謝謝。