Bionano Genomics Inc (BNGO) 2023 Q4 法說會逐字稿

Good day.

再會。

And welcome to the Bionano fourth quarter and full year 2023 earnings conference call.

歡迎參加 Bionano 第四季和 2023 年全年收益電話會議。

Today's conference is being recorded.

今天的會議正在錄製中。

At this time, I would like to turn the conference over to David Holmes from Investor Relations.

現在，我想將會議轉交給投資者關係部的 David Holmes。

Please go ahead.

請繼續。

Thank you, operator, and good afternoon, everyone.

謝謝接線員，大家下午好。

Welcome to the Bionano fourth quarter 2023 financial results conference call.

歡迎參加 Bionano 2023 年第四季財務業績電話會議。

Leading the call today is Dr. Erik Holmlin, CEO of Bionano.

今天主持電話會議的是 Bionano 執行長 Erik Holmlin 博士。

He is joined by Gulsen Kama, CFO of Bionano.

Bionano 財務長 Gulsen Kama 也加入了他的行列。

After market closed today, Bionano issued a press release announcing its financial results for the fourth quarter and full year of 2023.

今天收盤後，Bionano 發布新聞稿，宣布 2023 年第四季和全年財務業績。

A copy of the release can be found on the Investor Relations page of the company's website.

新聞稿的副本可以在該公司網站的投資者關係頁面上找到。

So I'd like to remind everyone that certain statements made during the conference call are forward looking, including statements about Bionano, strategic and commercialization plans, sales pipeline, future fundraising activities and prospects, cash runway, expected cost savings initiatives and the estimated impact on annualized operating expenses, the timing of expected benefits and such initiatives, expected reductions in head count, anticipated benefits or improvements to Stratys' Saphyr and Ionic purification system and there are advantages over current technologies goals and anticipated milestones for 2024.

因此，我想提醒大家，電話會議期間所做的某些陳述是前瞻性的，包括有關Bionano 的陳述、策略和商業化計劃、銷售管道、未來籌款活動和前景、現金跑道、預期成本節約舉措和估計影響關於年化營運費用、預期效益和此類措施的時間安排、預期人員減少、Stratys Saphyr 和 Ionic 淨化系統的預期效益或改進，以及相對於當前技術目標和 2024 年預期里程碑的優勢。

And achievements of the Elevate growth strategy, our anticipated compound annual growth rate, the size of our ability to access our estimated target markets, the anticipated benefits of recent acquisitions, expectations regarding the timing and the content study results and the anticipated benefits of these studies in driving adoption of the Stretta system, Saphyr system and the Ionic purification system.

Elevate 成長策略的成就、我們預期的複合年增長率、我們進入估計目標市場的能力規模、近期收購的預期收益、對時間和內容研究結果的預期以及這些研究的預期收益推動Stretta 系統、Saphyr 系統和離子淨化系統的採用。

Such forward-looking statements are based on current expectations, and there can be no assurances that the results contemplated in these statements will be realized.

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。

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 reported reports filing with the SEC.

由於多種因素和風險，實際結果可能與此類聲明有重大差異，其中一些因素和風險已在 bionano 的新聞稿和 bionano 向 SEC 提交的報告中確定。

These forward-looking statements are based on information available to Bionano today, and the Company assumes no obligation to update statements as circumstances change.

這些前瞻性陳述是基於 Bionano 目前掌握的信息，本公司不承擔隨著情況變化而更新陳述的義務。

In addition to supplement Bionano's financial results reported in accordance with the US, generally accepted accounting principles or GAAP.

除了補充 Bionano 根據美國公認會計原則或 GAAP 報告的財務表現外。

The Company is reporting non-GAAP operating expense.

該公司正在報告非公認會計準則營運費用。

This non-GAAP financial measure is not meant to be considered in isolation or as a substitute to comparable GAAP measures should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP and has no standardized, meaning prescribed by GAAP and is not prepared under any comprehensive set of accounting rules or principles.

此非公認會計原則財務指標不應被單獨考慮，也不能作為可比較公認會計原則指標的替代品，應與公司根據公認會計原則編制的合併財務報表結合起來閱讀，並且沒有標準化，即公認會計原則規定的含義，並且不屬於公認會計原則規定的標準。根據任何全面的會計規則或原則編制。

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 be available online on the Investor Relations page of the company's website.

今天稍早發布的公司收益報告末尾包含了對非 GAAP 營運費用的描述以及非 GAAP 營運費用與 GAAP 營運費用的調節，該報告已發佈在公司網站的投資者關係頁面上，音訊今天電話會議的錄音和網路廣播重播將在公司網站的投資者關係頁面上線上提供。

And with that I will turn the call over to Erik.

然後我會將電話轉給埃里克。

Thanks, David.

謝謝，大衛。

Good afternoon, everyone, and thank you for joining us today.

大家下午好，感謝您今天加入我們。

Today's call is an important one for Bionano.

今天的電話會議對 Bionano 來說是一次重要的會議。

We want to cover a lot of ground starting with an update on Q4 and the full year 2023.

我們希望從第四季度和 2023 年全年的更新開始涵蓋很多內容。

And then we want to cover the 2024 outlook, including important progress we are making to address our capital structure and cash burn.

然後我們要展望 2024 年的前景，包括我們在解決資本結構和現金消耗問題方面取得的重要進展。

I would like to first turn the call over to Gulsen to cover the financial results for Q4 and full year 2023.

我想先將電話轉給 Gulsen，介紹第四季和 2023 年全年的財務表現。

Gulsen?

古爾森？

Thanks, Eric.

謝謝，埃里克。

Consistent with our preannouncement in January, Q4 revenues were $10.7 million, which is up 30% versus Q4 2022. 2023 revenue totaled $36.1 million, which reflects an increase of 30% over 2022 revenues.

與我們 1 月預先宣布的一致，第四季營收為 1,070 萬美元，比 2022 年第四季成長 30%。2023 年營收總計 3,610 萬美元，比 2022 年營收成長 30%。

Our installed base of optical genome mapping systems grew by 25% from the third to the fourth quarter of 2023 for a total of 326 on December 31, 2023, which reflects a 36% increase from year-end 2022.

截至 2023 年 12 月 31 日，我們的光學基因組作圖系統安裝量從 2023 年第三季到第四季成長了 25%，總數達到 326 個，較 2022 年底成長了 36%。

We sold 7,984 sales in the quarter, which reflects 67% growth over Q4 2022.

本季我們售出 7,984 輛，比 2022 年第四季成長 67%。

For the full year, we saw 72% growth in the number of flow cells sold from 2022 to 2023 with a total of 26,444.

從 2022 年到 2023 年全年，我們銷售的流通池數量增加了 72%，總數達到 26,444 個。

This growth is important to note as we believe it indicates higher consumable utilization.

這種成長值得注意，因為我們認為這顯示消耗品利用率較高。

Given that consumables growth is outpacing installed base growth by a factor of two, we expect utilization to increase even more as the higher throughput Stratys' system becomes a larger percentage of our total installed base.

鑑於消耗品成長速度超過安裝基數成長的兩倍，我們預計，隨著更高吞吐量的 Stratys 系統在我們總安裝基數中所佔的比例更大，利用率將進一步增加。

In October 2023, we've completed an $80 million financing of convertible notes and warrants, and we ended the fourth quarter with $102.3 million in cash, cash equivalents and available-for-sale securities, of which $35.5 million were subject to some restrictions.

2023 年 10 月，我們完成了 8,000 萬美元的可轉換票據和認股權證融資，第四季末我們擁有 1.023 億美元的現金、現金等價物和可供出售證券，其中 3,550 萬美元受到一些限制。

On February 28, 2024, we announced an important restructuring of the convertible notes, which lowered the minimum available liquidity covenants from $50 million to $25 million, lowered the restricted cash covenant from $35 million to $25 million, which can be further reduced as remaining principal is retired.

2024 年2 月28 日，我們宣布對可轉換票據進行重要重組，將最低可用流動性契約從5000 萬美元降低至2500 萬美元，將限制性現金契約從3500 萬美元降低至2500 萬美元，隨著剩餘本金的增加，可進一步減少已退休。

Canceled the March partial redemption payment and delayed the April partial redemption payments to April 20, and redeemed $27.7 million in principal, leaving the outstanding debt at $24.3 million.

取消3月份的部分贖回付款，並將4月份的部分贖回付款推遲至4月20日，並贖回本金2770萬美元，使未償債務為2430萬美元。

This restructuring effectively unlocked $30 million with the potential to free up an additional $25 million as further principal is retired.

此次重組有效釋放了 3000 萬美元，隨著更多本金的退還，還有可能額外釋放 2500 萬美元。

Regarding operating expense, GAAP gross margin for the fourth quarter of 2023 was 23%, which is slightly higher than the 22% GAAP gross margin reported for the fourth quarter of 2022.

營運費用方面，2023 年第四季 GAAP 毛利率為 23%，略高於 2022 年第四季 22% 的 GAAP 毛利率。

Full year 2023, total gross margin was 26%, up from 21% and full year 2022.

2023 年全年，總毛利率為 26%，高於 2022 年全年的 21%。

Fourth quarter 2023 GAAP operating expense was $27.4 million compared to $39.3 million in the fourth quarter of 2022.

2023 年第四季 GAAP 營運費用為 2,740 萬美元，而 2022 年第四季為 3,930 萬美元。

The year-over-year decrease was primarily due to a decrease in the fair value of contingent consideration of PureGen milestones and reduced headcount related expense, partly attributed to the cost savings initiatives outlined in our Q2 2023 and Q3 2023 earnings releases.

年比下降主要是由於 PureGen 里程碑的或有對價公允價值下降以及人員相關費用減少，部分原因是我們 2023 年第二季度和 2023 年第三季度收益發布中概述的成本節約舉措。

Fourth quarter 2023 non-GAAP operating expense was $27.3 million compared to $30.6 million in the fourth quarter of 2022.

2023 年第四季非 GAAP 營運費用為 2,730 萬美元，而 2022 年第四季為 3,060 萬美元。

Full year 2023 GAAP operating expense was $224.8 million and non-GAAP operating expense was $127.3 million.

2023 年全年 GAAP 營運費用為 2.248 億美元，非 GAAP 營運費用為 1.273 億美元。

Full year 2023, non-GAAP operating expense excludes the onetime impairment charge of $77.3 million, $14.5 million in stock-based compensation and $7.2 million in amortization of intangibles, partially offset by a $1.5 million in reductions of contingency-based obligation.

2023 年全年，非 GAAP 營運費用不包括 7,730 萬美元的一次性減損費用、1,450 萬美元的股票薪酬和 720 萬美元的無形資產攤銷，部分被 150 萬美元的或有負債減少所抵銷。

Since joining Bionano, I have been focused on driving increased discipline to our spending while we work to extend our cash runway.

自從加入 Bionano 以來，我一直致力於加強支出紀律，同時努力擴大我們的現金跑道。

In October 2023, we announced the cost savings initiative that we believe together with reductions that began in May will save approximately $33 million annually, including a reduction in headcount of approximately 83 employees and reductions in discretionary spending on various projects.

2023 年 10 月，我們宣布了成本節約計劃，我們相信加上 5 月份開始的削減，每年將節省約 3300 萬美元，包括減少約 83 名員工以及減少各種項目的可自由支配支出。

Some of those savings, we're evident in our fourth quarter OpEx.

其中一些節省在第四季度的營運支出中顯而易見。

But for timing of employee expenses coming off the books, we expect to see the full benefit of the reductions starting in the first quarter of 2024.

但就員工費用計入帳面的時間而言，我們預計從 2024 年第一季開始就能看到削減的全部好處。

Today, Erik and I are announcing that we are implementing new plans that will further reduce expenses.

今天，艾瑞克和我宣布我們正在實施新計劃，以進一步減少開支。

Streamlining operations is possible because of the product launches behind us and a breadth of the current equity capital environment for tools and diagnostics companies, which is requiring companies to become much more efficient with resources and to reduce cash burn.

由於我們身後的產品發布以及工具和診斷公司當前股權資本環境的廣泛性，簡化營運是可能的，這要求公司提高資源效率並減少現金消耗。

With this 2024 initiative, our goal will be reducing annualized operating expense by another estimated $35 million to $40 million, including a potential reduction in headcount by an additional 110 to 125 employees, bringing the total number of employees down to approximately 200 from approximately 324 today.

透過這項 2024 年計劃，我們的目標是預計年化營運費用將再減少 3,500 萬至 4,000 萬美元，包括可能再減少 110 至 125 名員工，使員工總數從目前的約 324 人減少到約 200 人。

Overall since May 2023, through the completion of the initiatives announced today, we aim to have reduced headcount by approximately 200 people and reduced annualized operating expenses by about $65 million to $75 million.

總體而言，自 2023 年 5 月以來，透過完成今天宣布的舉措，我們的目標是減少約 200 名員工，並將年化營運費用減少約 6,500 萬至 7,500 萬美元。

We expect the savings initiatives we're announcing today to have associated costs.

我們預計今天宣布的節約措施將產生相關成本。

We will provide that information as appropriate once we have more completely finalized the cost associated with these plans.

一旦我們更完整地確定了與這些計劃相關的成本，我們將酌情提供該資訊。

As we streamline our operating structure, we believe we're cementing the path forward now.

隨著我們精簡營運結構，我們相信我們現在正在鞏固前進的道路。

Our core product development is mostly completed, and we're targeting segments of the genome analysis market where we believe we face no direct competition seeking to replace the core for classical cytogenetic methods with a single assay in contrast to the sequencing and spatial genomics markets which have become incredibly crowded.

我們的核心產品開發已基本完成，我們的目標是基因組分析市場的細分市場，我們相信我們不會面臨直接競爭，尋求以單一檢測取代經典細胞遺傳學方法的核心，而定序和空間基因組市場則相反。變得異常擁擠。

With that, I will turn the call back to Eric to discuss our 2024 anticipated business plan before we take your questions.

接下來，在回答您的問題之前，我將把電話轉回給 Eric，討論我們 2024 年的預期業務計劃。

Erik?

艾瑞克？

Thanks, Gulsen. 2023 was one of Bionano's most successful years ever with solid revenue growth and achievement of all our publicly stated elevate milestones.

謝謝，古爾森。 2023 年是 Bionano 有史以來最成功的一年，收入穩健成長，並實現了我們所有公開宣稱的升遷里程碑。

Despite the challenging backdrop from macro economic headwinds facing the industry.

儘管該行業面臨宏觀經濟逆風的挑戰。

Overall, we believe 2023 set the stage for a bright future for OGM. and the impact our products can make in health care, we believe the evidence is clear.

總體而言，我們相信 2023 年將為 OGM 的光明未來奠定基礎。以及我們的產品對醫療保健的影響，我們相信證據是明確的。

Elevate is working.

提升正在運行。

We saw substantial increase in OGM publications in 2023 with over 5,000 clinical genomes published and the highest recorded quarter to date, with 88 publications in the fourth quarter of 2023.

我們看到 2023 年 OGM 出版物大幅增加，發表了 5,000 多個臨床基因組，是迄今為止記錄最高的季度，2023 年第四季度有 88 篇出版物。

OGM studies, including our own clinical studies program, have now moved beyond showing concordance to focusing on demonstrations of the incremental value of OGM over classical methods.

OGM 研究，包括我們自己的臨床研究項目，現在已經超越了顯示一致性，而是專注於證明 OGM 相對於經典方法的增量價值。

Our product development team has brought two new transformative products to the market, which are key to the end to end solution for OGM via software and the Stratys system via software.

我們的產品開發團隊向市場推出了兩款新的變革性產品，它們是 OGM 軟體和 Stratys 系統端到端解決方案的關鍵。

It makes the visualization interpretation and reporting of OGM. data incredibly fast, automated and easy to digest it also enables analysis of chromosomal microarray and next-generation sequencing data together with OGM., which is a feature that is totally unique in the market.

它對OGM進行可視化解釋和報告。數據速度極快、自動化且易於消化，它還可以與 OGM 一起分析染色體微陣列和下一代定序數據，這是市場上獨一無二的功能。

The Stratys system increases the throughput of OGM data generation by as much as four bold compared to the Saphyr system, and we have a roadmap to further increase that throughput over time.

與 Saphyr 系統相比，Stratys 系統將 OGM 資料產生的吞吐量提高了四倍，並且我們制定了隨著時間的推移進一步提高吞吐量的路線圖。

Stratys was released in an early access program in Q4 and demand mix exceeded our planned supply of 10 systems.

Stratys 在第四季度的搶先體驗計劃中發布，需求組合超出了我們計劃的 10 個系統供應量。

We ended up with orders for 11 early access Stratys system, 70% of which went to new customers.

我們最終獲得了 11 個搶先體驗 Stratys 系統的訂單，其中 70% 流向了新客戶。

We're excited to introduce Stratys' live to the market at the upcoming ACMG meeting in Toronto, March 13 through the 16, including at a pre conference scientific event, hosted by Bionano on March 12 were Stratys' users will present their progress and at a reception for conference attendees on March 13.

我們很高興在即將於3 月13 日至16 日在多倫多舉行的ACMG 會議上向市場介紹Stratys 的live，其中包括3 月12 日由Bionano 主辦的會前科學活動，Stratys 用戶將展示他們的進展，並在3 月 13 日為與會者舉辦的招待會。

The next component of the streamlined end to end solution to come out is, I say, attack of Reese's or ITP for OGM on the Ionic system, which is currently in pre-commercial evaluation in the field now.

我說，簡化的端到端解決方案的下一個組成部分是 Reese 或 ITP 對 Ionic 系統進行 OGM 的攻擊，該系統目前正在進行該領域的預商業評估。

And we expect ITP for OGM to be released commercially in the second half of this year.

我們預計 OGM 的 ITP 將在今年下半年商用。

Looking ahead to executing elevate in 2024 with a further streamlined operating structure for aiming to limit the impact of downsizing on revenue growth in the core OGM products.

展望2024年實施提升，進一步精簡營運結構，旨在限制裁員對核心OGM產品收入成長的影響。

As part of that streamlining, However, we have made the difficult decision to phase out some of our clinical services products that we sell directly to physicians, namely our first step and next step DX products and our Fragile X tests, which are legacy non OGM tests.

然而，作為精簡的一部分，我們做出了艱難的決定，逐步淘汰我們直接銷售給醫生的一些臨床服務產品，即我們的第一步和下一步DX 產品以及我們的Fragile X 測試，這些產品是傳統的非OGM測試。

In 2023, these products generated around $7 million of the overall $36.1 million in revenues.

2023 年，這些產品的總收入為 3,610 萬美元，創造了約 700 萬美元。

Therefore, after taking into account discontinued products, we are guiding full year 2024 revenues to be in the range of $37 million to $41 million.

因此，考慮到已停產的產品，我們預計 2024 年全年營收將在 3,700 萬美元至 4,100 萬美元之間。

And first quarter 2024 revenues to be between $8.25million and $8.75 million.

2024 年第一季營收將在 825 萬美元至 875 萬美元之間。

We expect to install between 80 and 100 new optical genome mapping systems in 2024, but we think the net increase to the installed base, it may reflect some Saphyr to Stratys' upgrades.

我們預計到 2024 年將安裝 80 到 100 個新的光學基因組作圖系統，但我們認為安裝數量的淨增加可能反映了 Saphyr 到 Stratys 的一些升級。

So we expect we expect the OGM install base by the end of 2024 to be in the range of 381 to 401 system.

因此，我們預計到 2024 年底，OGM 安裝基數將在 381 至 401 個系統之間。

Regarding next steps on the path to OGM reimbursement, bionano labs submitted the dossier for local coverage determination coverage policy for Hemalignancies from multi ex Palmetto in the fourth quarter of 2023.

關於 OGM 報銷路徑的後續步驟，bionano 實驗室於 2023 年第四季度提交了針對多前 Palmetto 的血液惡性腫瘤的本地覆蓋確定覆蓋政策的檔案。

And the application was accepted, which is the first step in the process, Bionano labs is working with other OGM users to seek local coverage determinations from other Medicare administrative contractors or MACs in the US.

申請已被接受，這是該過程的第一步，Bionano 實驗室正在與其他 OGM 用戶合作，尋求美國其他 Medicare 行政承包商或 MAC 的本地承保決定。

In the meantime, customers continue to be successful in obtaining and using PLA codes to get reimbursement for OGM applications.

同時，客戶繼續成功取得並使用 PLA 代碼來獲得 OGM 申請的報銷。

We believe a category one CPT code is a more general solution to reimbursement coding for ODM in the US according to the AMA website, an application for a category one, CPT code for OGM in the 2024 cycle has been submitted.

根據 AMA 網站，我們認為一類 CPT 代碼是美國 ODM 報銷編碼的更通用解決方案，已提交 2024 年周期 OGM 的一類 CPT 代碼申請。

The process is confidential, and we are not able to confirm if it is one of our users in the US as the applicant name is not public information, widespread utilization of OGM is one criterion that the AMA will use in the evaluation of a CPT code application, and we believe it will be more meaningful.

這個過程是保密的，我們無法確認它是否是我們在美國的用戶之一，因為申請人姓名不是公開信息，OGM 的廣泛使用是 AMA 在評估 CPT 代碼時使用的標準之一的應用，相信會更有意義。

If OGM users are able to directly speak to the utility of the workflow, the CPT code application process unfolds over the next few months.

如果 OGM 使用者能夠直接談論工作流程的實用性，CPT 代碼申請流程將在接下來的幾個月內展開。

And so we're hopeful of a good outcome towards the end of the second quarter 2024.

因此，我們希望在 2024 年第二季末取得良好成果。

In 2024 our clinical studies, programs will focus mainly on [hememalignancies] in an effort to support the medical guidelines and reimbursement decisions connected to this application for OGM.

2024 年，我們的臨床研究、計劃將主要集中在[血液惡性腫瘤]，以努力支持與 OGM 申請相關的醫療指南和報銷決定。

Going forward, we will also maintain efforts to address regulatory requirements where they represent opportunities to clear the path for adoption.

展望未來，我們也將繼續努力滿足監管要求，這些要求為掃清採用道路提供了機會。

In closing, I want to emphasize that while we are facing challenges from the situation related to equity capital markets.

最後，我想強調的是，我們面臨著股權資本市場情勢的挑戰。

Our core business is healthy.

我們的核心業務健康發展。

Reducing expenses is a difficult but important step in addressing our financing overhang as we continue our mission to transform the way the world sees the genome.

當我們繼續履行改變世界看待基因組的方式的使命時，減少開支是解決融資過剩問題的一個困難但重要的步驟。

With that operator, we are ready to take questions to ask a question.

有了該操作員，我們就可以準備好提問了。

(Operator Instructions)

（操作員說明）

Sung Ji Nam, Scotiabank.

宋志南，豐業銀行。

Hi, thanks for taking the questions.

您好，感謝您提出問題。

So just a clarification to start off.

所以首先需要澄清一下。

For the $7 million, the revenue that's being discontinued from the our next steps and first step in Fragile X, are they all coming from the service revenue segment?

對於我們下一步和 Fragile X 第一步中停止的 700 萬美元收入，它們都來自服務收入部門嗎？

And then would you be able to kind of comment on kind of what the growth rate has been for that business over the years?

然後您能否對該業務多年來的成長率發表評論？

Yes, those are coming from what would be on services and on dividend growing a little bit.

是的，這些來自服務業和股息的成長。

But our expectations as we were looking ahead to 2024 before making the decision to discontinue them was that they would be mostly flat.

但在決定停止使用這些產品之前，我們展望 2024 年，預計它們將基本持平。

Got you.

明白你了。

Okay.

好的。

And then, Eric, great to hear kind of your focus on heme malignancies this year.

然後，艾瑞克，很高興聽到你今年對血紅素惡性腫瘤的關注。

Could you give us kind of an update on in terms of all the clinical studies underway?

您能否向我們介紹所有正在進行的臨床研究的最新情況？

Preclinical post I'm sorry, prenatal postnatal team and also solid tumor and what the status are and kind of what the next steps are for all of them?

抱歉，臨床前後期團隊以及實體腫瘤的產前產後團隊的狀況如何，接下來的步驟是什麼？

Yes, sure.

是的，當然。

So we've really made tremendous progress across all areas, perhaps with the exception of solid tumor, although we have the study which has been IRB approved and we're really waiting to just actually have really more bandwidth to and spent time on that particular study in both prenatal and postnatal.

因此，我們在所有領域確實取得了巨大的進展，也許除了實體瘤之外，儘管我們的研究已經獲得 IRB 批准，而且我們真的在等待真正擁有更多的頻寬並在該特定領域花費時間。產前和產後研究。

We had landmark publications that came out over the course of the year in 2023, really demonstrating the concordance with traditional methods and beginning to show some of the incremental benefits in diagnostic yield, especially for the postnatal study.

我們在 2023 年發表了具有里程碑意義的出版物，真正證明了與傳統方法的一致性，並開始顯示出診斷率的一些增量優勢，特別是對於產後研究。

And so we feel like we've created a really solid momentum for those studies, and it's going to be fine to let them sort of yes, filter into the market and for people to digest those data, there's really large data sets that show the the value of optical genome mapping as a replacement for traditional methods.

因此，我們覺得我們已經為這些研究創造了非常堅實的動力，讓它們滲透到市場並讓人們消化這些數據是很好的，有非常大的數據集顯示了光學基因組作圖替代傳統方法的價值。

And then hematologic malignancy study has also progressed significant publications, including peer-reviewed publications over the course of 2023 and our focus going forward.

然後，血液惡性腫瘤研究也取得了重要出版物的進展，包括 2023 年同行評審的出版物以及我們未來的重點。

There will build really to continue to pursue all of the endpoints that we intend to measure, which include the incremental benefits of optical genome mapping over traditional methods.

我們將真正繼續追求我們打算測量的所有終點，其中包括光學基因組作圖相對於傳統方法的增量優勢。

We've seen a little bit of that in some of the early studies and early publications, but we're going to continue to dig deeply into that.

我們在一些早期研究和早期出版物中已經看到了一些這一點，但我們將繼續深入研究。

And then we also want to be able to show changes in how cases are managed as a result of the information that comes out of these studies as well as a variety of health economic benefits.

然後，我們也希望能夠展示這些研究得出的資訊以及各種健康經濟效益所帶來的個案管理方式的變化。

And so yes, some of those endpoints for prenatal and postnatal might be a little bit delayed and we'll get them for him first.

所以，是的，產前和產後的一些終點可能會有點延遲，我們將首先為他取得這些終點。

But I think that this clinical trials program had developed such incredible momentum that a lot of the work will continue independently of our efforts, and that will allow us to focus the resources that we have on hand.

但我認為這個臨床試驗計劃已經發展瞭如此令人難以置信的勢頭，許多工作將獨立於我們的努力而繼續進行，這將使我們能夠集中我們手頭上的資源。

That's great.

那太棒了。

That's super helpful.

這非常有幫助。

And then just the last one for Gulsen.

然後是古爾森的最後一個。

Could you maybe talk about the your expectations for gross margin cadence for this year?

您能否談談您對今年毛利率節奏的預期？

I'm good to see continuous improvement there last throughout last year.

我很高興看到去年全年持續改善。

But I was wondering given the on the full commercial launch of Stratys' as well as the discontinuation of certain product lines, should we anticipate some disruption on the margin side, at least for the early part of the year?

但我想知道，考慮到 Stratys 的全面商業推出以及某些產品線的停產，我們是否應該預計利潤方面會出現一些中斷，至少在今年早些時候如此？

No, I don't think so.

不，我不這麼認為。

Is anything I think on some of the cost reductions that we announced will actually have an impact even on cost of revenues.

我認為我們宣布的一些成本削減實際上會對收入成本產生影響。

So just because of that, I think there will be an improvement.

正因為如此，我認為會有進步。

Got it.

知道了。

Great.

偉大的。

Thank you so much.

太感謝了。

Thank you, Sung.

謝謝你，宋。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey guys, thank you for the questions.

嘿夥計們，謝謝你們的提問。

And congrats on a strong 2023, maybe just starting with them, the headcount reductions.

祝賀 2023 年業績強勁，也許這只是裁員的開始。

So it looks like you're talking about a potential reduction number, I guess, have you I mean, you obviously provided the number.

所以看起來你在談論一個潛在的減少數字，我想，我的意思是，你顯然提供了這個數字。

So can you just give us a sense for what would move that from potential to moving it moving forward?

那麼您能否讓我們了解什麼可以將其從潛力轉變為向前發展？

And how should we think about the timing and then related to that, I know, Eric, you don't want to impact revenue or generating activities, but you know, that is a large number of folks.

我們應該如何考慮時間安排，然後與之相關，我知道，艾瑞克，你不想影響收入或產生活動，但你知道，有很多人。

So maybe just walk us through whether or not you think you're able to withhold cuts to commercial activities?

那麼，請告訴我們您是否認為自己能夠阻止商業活動的削減？

Sure.

當然。

So I think with regard to the language that we're using, I think a fair takeaway is that we're seeking to come from about 324, which is the head count that we're at now down to 200 and our experience when we did reductions in the fourth quarter was that for a variety of reasons, a few people here and there had to be taking in and moved out of the plan.

因此，我認為就我們正在使用的語言而言，我認為一個公平的結論是，我們正在尋求大約 324 名員工，這是我們目前減少到 200 名的員工人數，以及我們在第四季度確實減少了，因為各種原因，這裡那裡有一些人不得不接受和搬出計劃。

So we want to leave some room around the 200, but that's certainly the target that we're aiming for.

因此，我們希望在 200 左右留出一些空間，但這肯定是我們的目標。

So that would suggest a reduction right around 125 people.

因此，這意味著將減少 125 人左右。

And so as has been pointed out, as we discussed, these steps were and our incredible employees.

正如我們所討論的那樣，這些步驟以及我們令人難以置信的員工都是如此。

And as you can imagine, it's such a difficult decision to make to reduce these costs.

正如您可以想像的那樣，降低這些成本是一個非常困難的決定。

Those that sort of magnitude exceeds a third of the Company.

這些規模超過了公司的三分之一。

And so essentially, all areas of the Company will be impacted.

因此，從本質上講，公司的所有領域都將受到影響。

And one of the reasons that we decided to discontinue the services products was that there are a fair number of people associated with generating those revenues.

我們決定停止提供服務產品的原因之一是，有相當多的人與產生這些收入有關。

And so, that allows us to meet part of that headcount target in a single move.

因此，這使我們能夠一次性實現部分人員目標。

The other reason is that and what is important is that product flow is in the samples coming in the door and they provide some benefit to the advancement of OGM overall, they're not really core.

另一個原因是，重要的是產品流存在於進來的樣品中，它們為 OGM 的整體進步提供了一些好處，它們並不是真正的核心。

And so a key driver as we think about going forward is that we really wanted to be deeply focused on optical genome mapping and have all of our management resources dedicated to that.

因此，我們未來考慮的一個關鍵驅動因素是，我們確實希望深入關注光學基因組圖譜，並將我們所有的管理資源專門用於此。

So that helps with some of the numbers.

這對一些數字有幫助。

And then in order to address the remaining, we recognize that we've gone through some significant product developments via software is in the market.

然後，為了解決剩下的問題，我們認識到我們已經透過市場上的軟體進行了一些重要的產品開發。

The Stratys system is in the market.

Stratys系統已上市。

And so the incredible people who have helped us get to this point, we don't need as many of them going forward.

因此，那些幫助我們走到這一步的令人難以置信的人，我們不需要那麼多人繼續前進。

So that's a part of the transition.

這是過渡的一部分。

And then commercially, we do have some impact across sales and marketing and the way that we're balancing that is to really leverage where we have distribution partners and third parties that support our products in the market.

然後在商業上，我們確實在銷售和行銷方面產生了一些影響，我們平衡這一點的方式是真正利用我們在市場上支持我們產品的分銷合作夥伴和第三方。

We're really going to lean on them and they're going to have to they're going to have to deliver.

我們真的會依賴他們，他們也必須交付。

And so what you'll see is that maybe we're not going to be as ambitious about growing our commercial footprint and globally and internationally across [Asia Pac] and rest of world, and we'll maintain our very successful focus in Europe and United States and Canada.

因此，您會看到，也許我們不會那麼雄心勃勃地在亞太地區和世界其他地區擴大我們的商業足跡，並且我們將保持我們在歐洲和世界其他地區非常成功的重點。美國和加拿大。

So we are certainly going to impact head count there, but we want to want to keep the momentum in place that that we've built so far.

因此，我們肯定會影響那裡的員工數量，但我們希望保持迄今為止所建立的勢頭。

Okay.

好的。

And then maybe a clarification on the install base and the guidance looks like you're expecting a range of 80 to 100 systems this year.

然後可能會對安裝基礎和指南進行澄清，看起來您預計今年會有 80 到 100 個系統。

You did indicate you expect some conversions from Saphyr to Stratys.

您確實表示您期望從 Saphyr 到 Stratys 進行一些轉換。

Is it right that if I just do the math, you might have, let's see an increase of 65 systems overall, but the delta between the 65 and the 90 at the midpoint would be the conversions.

如果我算一下，您可能會看到，總體上增加了 65 個系統，但 65 和 90 之間的中間點的增量將是轉換。

I mean, is that based on that math right?

我的意思是，這是基於數學的嗎？

And then is that based on conversations you're having with customers?

那麼這是基於您與客戶的對話嗎？

And then maybe lastly, could you talk about mix between capital, reagent rental, how you think that might play out this year?

最後，您能否談談資本、試劑租賃之間的組合，您認為今年可能會如何發揮作用？

Sure.

當然。

Yes.

是的。

I think that your sort of math is correct there.

我認為你的數學計算是正確的。

Yes, we feel we feel confident about this.

是的，我們對此充滿信心。

This 80 to 100 new installs and there's the potential to get past that.

新增安裝量為 80 到 100 個，並且有可能超過這個數字。

But we wanted to make sure that we deliver against what we're signing up for here.

但我們希望確保我們能夠兌現我們在這裡簽署的協議。

And these conversions or upgrades, if you will on -- we have some visibility into that.

如果您願意的話，這些轉換或升級我們對此有一些了解。

But I think aside from the early access program, we're only about 45 days into the full commercial release of Stratys.

但我認為，除了搶先體驗計畫之外，距離 Stratys 的完整商業發布僅剩約 45 天。

And so the information that we're getting is is fairly new.

所以我們得到的資訊是相當新的。

And so the 25 upgrades is an estimate.

所以 25 次升級只是一個估計。

And so we'll just have to see how things play out going forward.

所以我們只能看看事情接下來會如何發展。

Okay.

好的。

And then last question for me is, It's nice to see you submit the dossier to Palmetto MolDX on.

我的最後一個問題是，很高興看到您向 Palmetto MolDX 提交了檔案。

Is it your expectation that 2024 is a year, obviously for them to review it maybe come up with a draft decision.

你是否期望2024年是他們顯然要審查的一年，也許會提出一個決定草案。

Do you think that might hit by year end?

您認為到年底可能會發生這種情況嗎？

And then maybe go final next year?

然後也許明年就能進入決賽？

Maybe just help us think about how you're thinking about timing?

也許只是幫助我們想想你是如何考慮時機的？

Yes.

是的。

So I can share some additional information that we've learned as part of the process EO, some kind of pre submission.

因此，我可以分享一些我們在 EO 流程（某種預先提交）中了解到的額外資訊。

And then subsequently is that there needs to be, you know, a determination as to whether this application is ultimately treated as a request for a completely new coverage policy or if it can be attached to any of the existing ones.

接下來，您知道，需要確定該申請最終是否被視為對全新承保保單的請求，或者是否可以將其附加到任何現有保單上。

And we're fairly certain that it's likely to be a new policy.

我們相當確定這可能是一項新政策。

And so for our own thinking in our own planning versus purposes, we treat it that way.

因此，對於我們自己的規劃與目的的思考，我們就是這樣對待的。

And I think it's reasonable to expect that it could take all of 2024 for a new draft coverage policy to come out.

我認為，有理由預期新的保險政策草案可能需要 2024 年一整年才能推出。

So the earliest that we would see it at it.

所以我們最早會看到它。

I think it's safe to say that we would see the draft policy early 2025.

我認為可以肯定地說，我們將在 2025 年初看到政策草案。

And with the potential for it to become final in 2025.

並且有可能在 2025 年成為最終版本。

Maybe that may be the folks working on it beat that, but I think that's a safe estimate.

也許從事這項工作的人可能會擊敗這個數字，但我認為這是一個安全的估計。

Yes, that makes sense.

是的，這是有道理的。

Alright, thanks for all the time.

好的，謝謝大家一直以來的陪伴。

Thank you, Mark.

謝謝你，馬克。

(Operator Instructions) Jeff Cohen, Ladenburg Thalmann.

（操作員說明）Jeff Cohen、Ladenburg Thalmann。

Well, good afternoon.

嗯，下午好。

Thanks for taking our questions.

感謝您回答我們的問題。

I wanted to follow up on Mark's previous question.

我想跟進馬克之前的問題。

Could you comment a little bit on the count one CPT code and DNA from what you know currently and how might that play out over '24 and as that plays out well, then when would that take effect?

您能否根據您目前所知對第一 CPT 代碼和 DNA 進行一些評論，以及在 24 年期間如何發揮作用，並且如果效果良好，那麼什麼時候會生效？

Sure.

當然。

Thanks, Jeff.

謝謝，傑夫。

So I think in contrast to prior years where Bionano has led the process to apply for the CPT code.

因此，我認為與前幾年相比，Bionano 主導了 CPT 代碼的申請流程。

I think what we learned in that process is that as the manufacturer of the technology is it's difficult for us to really provide the information.

我認為我們在這個過程中學到的是，作為技術的製造商，我們很難真正提供資訊。

And so we were pleased to see that an application for a CPT code has been made this year and what we know with with certainty is that we were not the applicant.

因此，我們很高興看到今年已經提出了 CPT 代碼的申請，我們可以肯定地知道我們不是申請人。

And so it's reasonable to conclude that the applicant is a user.

因此可以合理地得出申請人是使用者的結論。

And as we sort of indicated in our prepared remarks, we're not able to sort of confirmed their identity because it's a confidential process.

正如我們在準備好的演講中指出的那樣，我們無法確認他們的身份，因為這是一個保密過程。

Having said that, the process is standardized and plays out over the next two or three months.

話雖如此，該流程已經標準化，並在接下來的兩三個月內完成。

And so I think that what we're likely to see is the application proceeding and the applicants will know sometime in late May early June, where it stands and then us as observers from the outside.

因此，我認為我們可能會看到申請正在進行，申請人將在五月底六月初的某個時候知道它的情況，然後我們作為外部觀察員。

We will know if the code is advanced into the agenda of the final meetings, which take place in June.

我們將知道該準則是否會被納入 6 月舉行的最終會議的議程中。

That agenda is published shortly before the meeting.

該議程在會議前不久公佈。

So I think we'll all be watching very closely over the next couple of months to see how the situation unfolds.

因此，我認為我們都將在接下來的幾個月中密切關注事態的發展。

Okay.

好的。

Got it.

知道了。

That's helpful.

這很有幫助。

Could you talk a little bit about the Stratys placements.

能談談 Stratys 的展示位置嗎？

I know it's a reflection phone that you had mentioned seven out of 10 were new customers.

我知道這是一款反射手機，您提到十分之七是新客戶。

Can you walk us through perhaps the methodology or the thinking there as far as those customers wanting a higher throughput system and perhaps some flavor as far as what types of accounts they were?

您能否向我們介紹一下那些想要更高吞吐量系統的客戶的方法或想法，以及他們的帳戶類型？

Yes, across the board, our accounts and I think that this has been a consistent pattern now for a while and we should start emphasizing it more with the these are all either academic medical centers like hospitals or some regional reference labs or commercial labs.

是的，總的來說，我們的帳戶，我認為這已經是一段時間以來的一致模式，我們應該開始更多地強調這一點，這些都是學術醫療中心，如醫院或一些區域參考實驗室或商業實驗室。

And and we also have systems go into pharmaceutical companies.

我們也有系統進入製藥公司。

So what we don't see anymore, and I think that this is a really important transition that we've undergone.

所以我們不再看到什麼，我認為這是我們經歷的一個非常重要的轉變。

We don't see the academic research centers who are buying optical genome mapping to create the next reference genome for this species or that species on there's a little bit of genetic and genomic mechanistic work going on.

我們沒有看到學術研究中心購買光學基因組圖譜來為這個物種或那個物種創建下一個參考基因組，正在進行一些遺傳和基因組機制工作。

But just about [ICE] of substantially all of our adoption is really in our target market of routine use in hematologic malignancy research on constitutional genetic disease research and then applications in cell and gene therapy.

但我們幾乎所有採用的[ICE]實際上都是在我們的目標市場中常規使用的血液惡性腫瘤研究、體質遺傳疾病研究以及細胞和基因治療中的應用。

So I'm super pleased about that.

所以我對此非常高興。

And then when we look at the Stratys' system and the folks who've raised their hands without a doubt, they see it as the the thing that they've been waiting for that provides them new, higher throughput.

然後，當我們看到 Stratys 的系統和毫無疑問舉手的人們時，他們認為這是他們一直在等待的東西，可以為他們提供新的、更高的吞吐量。

There are also other characteristics of the Stratys' system that make it attractive to users, which include really a lot of flexibility coming to introducing samples into the system and generating data.

Stratys 系統還有其他一些吸引使用者的特徵，其中包括在將樣本引入系統和生成資料方面具有很大的靈活性。

For example, the stratys system can run 12 samples at a time, but also accommodate up to 3 additional samples in a it just in time sort of fashion where you can jump the queue and get ahead and wrap run urgent samples.

例如，stratys 系統可以一次運行 12 個樣本，但也可以以及時的方式容納最多 3 個額外樣本，您可以跳過隊列，搶先運行緊急樣本。

And so the flexibility in the workflow, coupled with the higher throughput is something that labs are finding very interesting and very attractive and something else that we're seeing is that of your accounts that had been in our pipeline in the process of purchasing optical genome mapping are making the shift from Saphyr to Stratys.

因此，工作流程的靈活性以及更高的吞吐量是實驗室發現非常有趣和非常有吸引力的東西，我們看到的其他東西是在購買光學基因組的過程中一直在我們的管道中的您的帳戶製圖正在從 Saphyr 轉向 Stratys。

And I don't know if markets still.

我不知道市場是否還在。

And but he had also asked about the kind of distribution of rentals to capital purchases.

但他也詢問了租金與資本購買的分配方式。

And for a while now we've seen a very rough 50 50 distribution, but we're actually seeing a little bit more of purchases with Stratys'.

一段時間以來，我們看到了非常粗略的 50 50 分佈，但實際上我們看到使用 Stratys 的購買量有所增加。

And that's that's encouraging.

這就是令人鼓舞的。

That's helpful.

這很有幫助。

And then finally for us, your goals, in particular, when we talk about the OpEx reductions for '24.

最後，對於我們來說，您的目標，特別是當我們談論 24 年營運支出削減時。

If we do some quick math off the 23 numbers less the impairment and where you're leaning toward, we're getting call it about at 115 to 120 for full year '24.

如果我們對減去損傷的 23 個數字以及您傾向於的方向進行一些快速計算，我們會發現 24 年全年的數字約為 115 到 120。

And could you maybe comment on that and then perhaps give us a little insight into how you see that breaking down between our R&D and on SG&A?

您能否對此發表評論，然後向我們介紹一下您如何看待我們的研發與銷售、管理和管理之間的分歧？

So in terms of 2024 impact, specifically not the annualized on savings numbers, which of what we announced it will take some time to implement the savings initiatives.

因此，就 2024 年的影響而言，特別是年化儲蓄數字，我們宣布的儲蓄計畫需要一些時間才能實施。

And so we'll most likely see a partial year impact as a result of the most recent announced ones.

因此，我們很可能會看到由於最近宣布的影響而產生的部分年度影響。

And the ones that we announced in October should be in full effect by now.

我們在 10 月宣布的那些現在應該已經完全生效。

So yes, the number that you mentioned, I would please divide by two, I guess in terms of some of the impact in 2024 for specifically.

所以，是的，您提到的數字，我想將其除以二，我想具體是針對 2024 年的一些影響。

And, I'm sorry, what was the second part of your question?

抱歉，您問題的第二部分是什麼？

(Multiple Speakers)

（多位發言者）

Yes, I think as Eric mentioned, it's both are new product development with with Stratys already rolled out, but it's also on the commercial side.

是的，我認為正如 Eric 所提到的，這都是新產品開發，Stratys 已經推出，但它也是商業方面的。

So on for now again, I can get back to you, but I would expect equals what almost.

現在，我可以再次回覆您，但我希望與您差不多。

Got it.

知道了。

Okay, that's super helpful.

好的，這非常有幫助。

Thanks for your questions.

感謝您的提問。

Congrats on the quarter.

恭喜本季。

Thank you.

謝謝。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Hey, guys, this is Michael accumulates on the line for Jason.

嘿，夥計們，這是邁克爾為傑森積累的線路。

Thank you so much for taking my questions today.

非常感謝您今天回答我的問題。

It might go up because I guess just the first question I just wanted to get a point of clarification.

它可能會上升，因為我想這只是第一個問題，我只是想得到澄清。

Is the full year '24 revenue guidance fully factoring in the removal of those legacy tests?

24 年全年收入指引是否充分考慮了刪除這些遺留測試的情況？

I'm trying to understand if it's appropriate to consider the core growth rate there to be 27% to 40%.

我試圖了解將核心成長率設定為 27% 至 40% 是否合適。

Yes, it is fully factoring in the reduction and or removal of those revenues.

是的，它充分考慮了這些收入的減少和/或取消。

We're probably going to see a little bit of them in the first quarter.

我們可能會在第一季看到其中的一些。

So I think at the high end of that range, we're really aiming to get to 30% growth in the core.

因此，我認為在該範圍的高端，我們真正的目標是在核心領域實現 30% 的成長。

Thank you.

謝謝。

I'm showing no further questions at this time.

我目前沒有提出任何進一步的問題。

I would now like to (inaudible) closing remarks.

我現在想（聽不清楚）致結束語。

Okay.

好的。

Thank you, Daniel.

謝謝你，丹尼爾。

And I want to thank everybody for joining in the call, and we look forward to updating you shortly on our progress here in the first quarter of 2024.

我要感謝大家加入此次電話會議，我們期待盡快向您通報 2024 年第一季我們的進度。

Thank you very much.

非常感謝。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。