Bionano Genomics Inc (BNGO) 2023 Q3 法說會逐字稿

Good day. And welcome to Bionano third-quarter 2023 earnings conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to David Holmes from Investor Relations. Please go ahead.

再會。歡迎參加 Bionano 2023 年第三季財報電話會議。今天的會議正在錄製中。現在，我想將會議轉交給投資者關係部的 David Holmes。請繼續。

Thank you, operator, and good afternoon, everyone. Welcome to the Bionano third quarter 2023 financial results conference call. Leading the call today is Dr. Erik Holmlin, CEO of Bionano. He is joined by Gülsen Kama, CFO of Bionano.

謝謝接線員，大家下午好。歡迎參加 Bionano 2023 年第三季財務業績電話會議。今天主持電話會議的是 Bionano 執行長 Erik Holmlin 博士。 Bionano 財務長 Gülsen Kama 也加入了他的行列。

After market closed today, Bionano issued a press release announcing its financial results for the third quarter of 2023. A copy of the release can be found on the Investor Relations page of the company's website.

今天收盤後，Bionano 發布了一份新聞稿，宣布其 2023 年第三季的財務業績。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。

I would like to remind everyone that certain statements made during this conference call may be forward-looking, including statements about Bionano's annual and quarterly revenue outlook, profitability, cash runway, commercialization and product plans, its strategic pillars and associated publicly announced milestones, the anticipated benefits and the timing of those benefits from the announced reduction in force and other cost savings initiatives, advances in obtaining reimbursement and FDA clearance for OGM and Bionano's expectations regarding study results and publications and anticipated benefits of these studies and publications in driving adoption of OGM.

我想提醒大家，本次電話會議期間所做的某些陳述可能具有前瞻性，包括有關Bionano 年度和季度收入前景、盈利能力、現金跑道、商業化和產品計劃、其戰略支柱和相關公開宣布的里程碑、宣布的減少兵力和其他成本節約舉措的預期效益和這些效益的時間、獲得OGM 報銷和FDA 批准的進展以及Bionano 對研究結果和出版物的期望以及這些研究和出版物在推動OGM 採用方面的預期效益。

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. Actual results may differ materially from such statements due to a number of factors and risks, some of which are identified in biomass press release and bio and analyst reports filed with the SEC. These forward-looking statements are based on information available to Bionano today, November 8, 2023, 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。由於許多因素和風險，實際結果可能與此類聲明有重大差異，其中一些在生物質新聞稿以及向 SEC 提交的生物和分析報告中已確定。這些前瞻性陳述是基於 Bionano 今天（2023 年 11 月 8 日）獲得的信息，該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 US Generally Accepted Accounting Principles or GAAP, the company is reporting non-GAAP operating expense and non-GAAP gross margin.

除了補充 Bionano 根據美國公認會計原則 (GAAP) 報告的財務業績外，該公司還報告非 GAAP 營運費用和非 GAAP 毛利率。

These non-GAAP financial measures are 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, have no standardized meaning prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles.

這些非 GAAP 財務指標不應單獨考慮，也不應作為可比較 GAAP 指標的替代品，應與公司根據 GAAP 編制的合併財務報表結合起來閱讀，沒有 GAAP 規定的標準化含義，且未編制根據任何全面的會計規則或原則。

A description of both non-GAAP operating expense and non-GAAP gross margin and reconciliations of non-GAAP operating expense to GAAP operating expense and non-GAAP gross margin to GAAP gross margin are identified 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 on the company's Investor Relations page.

今天稍早發布的公司收益報告末尾列出了非 GAAP 營運費用和非 GAAP 毛利率的說明，以及非 GAAP 營運費用與 GAAP 營運費用以及非 GAAP 毛利率與 GAAP 毛利率的調整表，該資訊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路廣播重播也將在公司的投資者關係頁面上線上提供。

And with that, I'd like to turn the call over to Eric.

說到這裡，我想把電話轉給艾瑞克。

Thank you, David, and good afternoon, everyone. We accomplished a lot in Q3 and we look forward to discussing the progress in detail. Importantly, we took significant steps to reduce operating expenses and to extend our cash runway, which together help shorten the potential path to profitability.

謝謝大衛，大家下午好。我們在第三季取得了很多成就，我們期待詳細討論進展。重要的是，我們採取了重大措施來減少營運費用並擴大我們的現金跑道，這共同有助於縮短潛在的獲利之路。

The focus on managing expenses and driving toward profitability is in part by facilitated by the change in financial leadership of the company with the appointment of Gülsen Kama to the role of CFO, which was effective September 11th, 2023. Gülsen is going to open the call today by walking you through our financial results for the quarter and explaining how some of the initial steps in our streamline operational plan will reduce costs. Gülsen?

公司財務領導層的變化促進了對管理費用和推動盈利的關注，任命 Gülsen Kama 擔任首席財務官，該任命於 2023 年 9 月 11 日生效。Gülsen 將開啟電話會議今天，我們將向您介紹我們本季度的財務業績，並解釋我們簡化營運計劃中的一些初步步驟將如何降低成本。古爾森？

Thanks, Erik. I'm pleased to be on Board at Bionano and to join the effort to help expand the adoption and utilization of OGM around the world. To achieve that goal, we have to be financially disciplined as we seize the opportunities ahead of us.

謝謝，埃里克。我很高興成為 Bionano 的一員，並共同努力幫助擴大 OGM 在全球的採用和利用。為了實現這一目標，我們在抓住面前的機會時必須遵守財務紀律。

With that, let me share our results for the third quarter of 2023 with you. Revenue was $9.3 million, representing a 29% year-over-year increase to the same period of 2022, which exceeded our original guidance of 8.8 to $9.2 million provided on our second quarter earnings call and is in line with our earnings press release.

接下來，讓我與您分享我們 2023 年第三季的業績。營收為 930 萬美元，較 2022 年同期年增 29%，超出了我們在第二季財報電話會議上提供的 880 至 920 萬美元的原始指導，並且與我們的財報新聞稿一致。

The Saphyr installed base grew to 301 systems during Q3, which represents an increase of 20 systems in the quarter and 39% growth over the installed base of 217, at the end of Q3 2022. We sold 6,176 flowcells in Q3 2023, which represents a 55% year-over-year increase over the 3,975 flowcells sold in the same period last year.

Saphyr 安裝基數在第三季成長到301 個系統，這意味著本季增加了20 個系統，比2022 年第三季末的217 個系統安裝基數增加了39%。我們在2023 年第三季銷售了6,176 個流通池，這意味著與去年同期銷售的 3,975 個流通池相比，年增 55%。

GAAP gross margin for the third quarter was 30% compared to 25% during Q3 2022, and non-GAAP gross margin was 32% compared to 25% in the same quarter last year. Third quarter 2023, non-GAAP gross margin excludes $0.2 million in stock-based compensation.

第三季的 GAAP 毛利率為 30%，而 2022 年第三季為 25%；非 GAAP 毛利率為 32%，去年同期為 25%。 2023 年第三季度，非 GAAP 毛利率不包括 20 萬美元的股票薪酬。

Third Quarter 2023, GAAP operating expense was $116 million compared to $34 million in the same period in 2022. Non-GAAP operating expense in Q3 2023, which excludes $84.1 million in GAAP charges, as described in our press release, mainly comprised of a one-time impairment charge of $77.3 million related to revaluation of goodwill was $31.8 million compared to $26.3 million in Q3 2022. The increase was driven by higher headcount, R&D, and marketing expenses related to product launches.

2023 年第三季度，公認會計準則營運費用為1.16 億美元，而2022 年同期為3,400 萬美元。2023 年第三季度的非公認會計準則營運費用，不包括8,410 萬美元的公認會計準則費用，如我們的新聞稿所述，主要包括與商譽重估相關的期間減損費用為7,730 萬美元，為3,180 萬美元，而2022 年第三季為2,630 萬美元。這一增長是由於與產品發布相關的員工人數、研發和行銷費用增加所致。

Non-GAAP operating expense in the third quarter went down $2.8 million compared to $34.6 million in Q2 2023, mainly as a result of headcount reductions implemented in May of this year. We raised net proceeds of $12.7 million on our ATM facility, selling on a split-adjusted basis, 2.11 million shares at an average price of $6.16 per share. Our cash, cash equivalents, and available-for-sale securities as of September 30, 2023, was 63 points, $6 million.

第三季的非公認會計準則營運費用下降了 280 萬美元，而 2023 年第二季為 3,460 萬美元，這主要是由於今年 5 月實施的裁員所致。我們透過 ATM 設施籌集了 1,270 萬美元的淨收益，在分割調整的基礎上以每股 6.16 美元的平均價格出售 211 萬股股票。截至 2023 年 9 月 30 日，我們的現金、現金等價物及可供出售證券為 63 點，600 萬美元。

Now I want to discuss the steps we have taken since the end of the quarter to streamline operations and to extend our cash runway. On October 9, we implemented additional cost reductions in continuation of the reductions initiated in May of 2023.

現在我想討論一下自本季末以來我們為簡化營運和擴大現金跑道所採取的步驟。 10 月 9 日，我們繼續實施 2023 年 5 月開始的成本削減措施，進一步削減成本。

These cost savings initiatives include a reduction in force and steps to reduce facility costs and discretionary spending unrelated to headcount. When taken together with the cost savings realized from the reduction in force the company announced in May, we expect to see an annual cost savings of approximately $33 million starting in 2024.

這些成本節約措施包括減少人員以及採取措施降低設施成本和與員工人數無關的可自由支配支出。加上公司 5 月宣布的裁員所實現的成本節省，我們預計從 2024 年開始每年可節省約 3,300 萬美元的成本。

We also announced the completion of $80 million registered offering and concurrent private placement. Our objective with this financing was to obtain enough capital to provide a meaningful extension in the cash runway while also managing the dilutive impact. We believe we found a good balance in achieving both objective through this financing.

我們也宣布完成 8000 萬美元的註冊發行和同步私募。我們此次融資的目標是獲得足夠的資金，以有意義地擴展現金跑道，同時管理稀釋影響。我們相信，透過此次融資，我們在實現這兩個目標方面找到了良好的平衡。

Back to you, Erik.

回到你身邊，艾瑞克。

Thanks Gülsen and welcome aboard. Great results and congratulations on your first earnings call. We're pleased to have your energy and skills as we navigate an important phase for Bionano.

感謝古爾森，歡迎加入。取得了很好的成果，恭喜您召開第一次財報電話會議。我們很高興在 Bionano 邁向重要階段時擁有您的精力和技能。

I would now like to talk to everyone on the call about our plan going forward. I've just returned from the annual meeting of the American Society of Human Genetics in Washington, D.C., where thousands of clinical researchers, lab directors, and physicians meet to discuss the latest advances in human genetics.

現在我想與電話會議中的每個人討論我們的未來計劃。我剛從華盛頓特區舉行的美國人類遺傳學協會年會回來，數千名臨床研究人員、實驗室主任和醫生齊聚一堂，討論人類遺傳學的最新進展。

Based on the overwhelming number of talks, posters, publications, and mentions of optical genome mapping. I and my whole team believe that OGM is now widely recognized as a powerful alternative to traditional cytogenetics with the potential to have a tremendous impact on health outcomes and health economics.

基於大量關於光學基因組圖譜的演講、海報、出版物和提及。我和我的整個團隊相信，OGM 現在被廣泛認為是傳統細胞遺傳學的強大替代品，有可能對健康結果和衛生經濟學產生巨大影響。

Our strategy moving forward is straightforward. We need to accelerate revenue growth and operate efficiently to reach profitability.

我們前進的策略很簡單。我們需要加速收入成長並高效運作以實現獲利。

When we first established the ELEVATE strategy, it was based on six pillars. We now see it's more important than ever to be focused on those strategies that will result in achieving our goals in as expeditious -- manner as possible. Therefore, moving forward, ELEVATE will be based on four pillars. Number one, expand global adoption and utilization of OGM in hematologic malignancies, cell and gene therapy, and rare diseases with a robust end-to-end workflow as an alternative to traditional cytogenetic techniques for efficient detection analysis and reporting of structural variants.

當我們首次製定 ELEVATE 策略時，它是基於六大支柱。我們現在看到，比以往任何時候都更重要的是，要專注於那些能夠盡可能迅速地實現我們目標的策略。因此，展望未來，ELEVATE 將基於四大支柱。第一，透過強大的端到端工作流程，擴大OGM 在血液惡性腫瘤、細胞和基因治療以及罕見疾病中的全球採用和利用，作為傳統細胞遺傳學技術的替代方案，以有效檢測分析和報告結構變異。

Number two, clear the path for a value-based reimbursement of OGM and inclusion of OGM analysis into Medical Society Guidelines by addressing the need for large data sets, showing clinical and health economic value of OGM.

第二，透過滿足大數據集的需求，顯示 OGM 的臨床和健康經濟價值，為基於價值的 OGM 報銷以及將 OGM 分析納入醫學會指南掃清道路。

Number three, obtain regulatory clearances in the United States and the European Union to make adoption of OGM easier for labs that require such clearances.

第三，獲得美國和歐盟的監管許可，以便需要此類許可的實驗室更容易採用 OGM。

And number four, drive operational efficiency to shorten the path to profitability. We're making great progress along these strategic pillars.

第四，提高營運效率，縮短獲利之路。我們正在沿著這些戰略支柱取得巨大進展。

In addition to strong revenue this quarter, we saw growth in the adoption and utilization of optical genome mapping with increases in the installed base of Saphyr systems and growth in flowcells sold.

除了本季強勁的收入外，我們還看到光學基因組圖譜的採用和利用有所增長，Saphyr 系統的安裝基數有所增加，流通池銷量也有所增長。

Installations of our newly released VIA software as a critical component of the end-to-end workflow, [first for heme] began at the end of July. Many laboratories are now in various stages of integrating VIA for visualization, interpretation, and reporting of OGM data.

我們新發布的 VIA 軟體作為端到端工作流程的重要組成部分，[首次用於 heme] 已於 7 月底開始安裝。許多實驗室目前處於整合 VIA 以實現 OGM 數據視覺化、解釋和報告的不同階段。

The response to the early access program for the Stratys system has really exceeded our expectation. Stratys systems are now in the field and installation and testing have begun. Full commercial availability of Stratys is expected for early in 2024 based on our ability to ramp production.

Stratys 系統搶先體驗計畫的反應確實超出了我們的預期。 Stratys 系統現已投入使用，安裝和測試也已開始。根據我們提高產量的能力，Stratys 預計將於 2024 年初全面商業化。

Automating sample preparation is an important component to the front-end of the OGM workflow as VIA is to streamlining the back end. Ou development work to adapt isotachophoresis or ITP for the isolation of ultra-high molecular weight DNA for OGM. on the Ionic system is progressing well and we're on track to have a pre-commercial version of that capability in the field by the end of this year.

自動化樣品製備是 OGM 工作流程前端的重要組成部分，因為威盛致力於簡化後端。 Ou 致力於採用等速電泳或 ITP 來分離用於 OGM 的超高分子量 DNA。 Ionic 系統的開發進展順利，我們預計在今年年底前在該領域推出該功能的預商業版本。

Hamilton, which offers the long string Star V system for isolating DNA for OGM presented data at the ASHG conference showing their systems to perform well. They also discussed their plans to automate the DNA labeling step for OGM. Automating as much of this workflow as possible is really important to driving maximum utilization of the higher throughput that Stratys brings to market.

Hamilton 為 OGM 提供用於分離 DNA 的長串 Star V 系統，在 ASHG 會議上提供的數據表明他們的系統表現良好。他們還討論了 OGM 自動化 DNA 標記步驟的計劃。盡可能自動化此工作流程對於最大限度地利用 Stratys 推向市場的更高吞吐量非常重要。

We also saw amazing progress around reimbursement of OGM based test, as two labs, Praxis Genomics and Augusta University received an approval from CMS $1,863.22 for their proprietary analysis or PLA codes for hematologic malignancy testing after going through the gap-fill process with CMS. Regarding the critical mass of data in the field that's required to influence third-party payers and impact medical societies as they're evaluating the inclusion of OGM into their guidelines.

我們還看到在基於OGM 的測試報銷方面取得了驚人的進展，Praxis Genomics 和奧古斯塔大學這兩個實驗室在與CMS 完成缺口填充流程後，獲得了CMS 1,863.22 美元的批准，用於其用於血液惡性腫瘤測試的專有分析或PLA 代碼。關於影響第三方付款人和醫學協會在評估將 OGM 納入其指南時所需的該領域的臨界數據量。

I'd like to highlight the terrific growth we saw this quarter in the number of publications. Overall publications featuring OGM were up 61% from Q3 2020 to Q3 2023, including a total of 47 human focused publications which demonstrates the utility of OGM in clinical research. The number of publications on rare diseases grew a remarkable 172% from 2022 to 2023, with increasingly large average numbers of samples per study.

我想強調一下本季出版物數量的驚人增長。從 2020 年第三季到 2023 年第三季度，以 OGM 為主題的出版物總數增加了 61%，其中總共有 47 篇以人類為中心的出版物，證明了 OGM 在臨床研究中的實用性。從 2022 年到 2023 年，有關罕見疾病的出版數量顯著增加了 172%，每項研究的平均樣本數量也不斷增加。

Now we have also formally engaged with the FDA around a future FDA cleared assays to be run on the Stratys system, and we've received positive initial feedback, and that process will continue into 2024.

現在，我們也正式與 FDA 就未來 FDA 批准的在 Stratys 系統上運行的檢測進行接觸，我們已經收到了積極的初步反饋，該過程將持續到 2024 年。

Looking ahead at strategic milestones we've previously outlined for the second half of 2023. We remain on track to meet our goal of installing 325 optical genome mapping systems by the end of 2023. Our prenatal and postnatal and hemeo malignancy studies remain on track to meet the associated milestones planned for the end of this year.

展望我們先前概述的 2023 年下半年的戰略里程碑。我們仍有望實現到 2023 年底安裝 325 個光學基因組作圖系統的目標。我們的產前和產後以及血紅素惡性腫瘤研究仍有望實現今年年底計劃的相關里程碑。

And finally, I want to reiterate our full year 2023 revenue guidance, which we originally provided at the outset of the year of $35 million to $38 million in top-line revenue. We look forward to updating you on our Q4 call regarding the progress toward the remaining 2023 milestones.

最後，我想重申我們的 2023 年全年收入指導，我們最初在年初提供的收入指導為 3500 萬至 3800 萬美元。我們期待在第四季電話會議上向您通報 2023 年剩餘里程碑的進展。

Operator, please go ahead and open the line for questions.

接線員，請繼續撥打電話提問。

(Operator Instructions) Jason McCarthy, Maxim Group.

（操作員說明）Jason McCarthy，Maxim Group。

Hey, guys. Thank you for taking the question. This is Michael Okunewitch, which on the line for Jason.

大家好。感謝您提出問題。我是麥可‧奧庫內維奇，是傑森的電話。

So I guess to kick off, I'd like to see if you could just give a little bit more of -- more clarity on what the pathway is to gaining FDA approval for the assay on the Stratys system. What data do you need to produce for that?

因此，我想首先，我想看看您是否可以提供更多信息，更清楚地說明獲得 FDA 批准在 Stratys 系統上進行檢測的途徑是什麼。為此您需要產生什麼數據？

Yeah. Hey, thanks, Michael. So the process involves a series of engagements with FDA followed by a clinical study. The clinical study is relatively small and can be conducted within a reasonably short period, we'll likely do that trial later in 2024.

是的。嘿，謝謝，麥可。因此，該過程涉及與 FDA 的一系列合作，然後進行臨床研究。這項臨床研究規模相對較小，可以在相當短的時間內進行，我們可能會在 2024 年稍後進行該試驗。

And we would be seeking to establish substantial equivalence to existing standard of care methodologies and part of the discourse that's ongoing with the FDA right now is the specific clearance path that we choose. We're fairly convinced, although it remains to be something that the FDA and we agree upon, but we're fairly convinced that pre-market approval won't be required, but there are other paths around 510(K) clearance that we would need to decide to follow and then get support with the FDA. So we're engaged in those discussions now.

我們將尋求與現有的護理方法標準實質上等效，目前 FDA 正在進行的討論的一部分是我們選擇的具體清除路徑。我們相當確信，儘管這仍然是 FDA 和我們達成一致的事情，但我們相當確信不需要上市前批准，但我們還有其他圍繞 510(K) 許可的途徑需要決定遵循並獲得 FDA 的支持。所以我們現在正在進行這些討論。

And there are certain aspects of product development ongoing to support that trial around the proper documentation in connection with the development of the product, the software, and the assay as one integrated system. But we'll be in a position, we currently hope to conduct that clinical trial sometime later in 2024.

產品開發的某些方面正在進行中，以圍繞與產品、軟體和檢測作為一個整合系統的開發相關的適當文件來支援該試驗。但我們目前希望在 2024 年稍後進行臨床試驗。

All right. Thank you. And then, I would like to follow up and see if you could provide a bit more color on the financing and in particular in the context of trying to understand your cash balance and how that looks going forward? Could you explain a bit more about how the redemption feature works that was utilized on November 1? And then, do the redemptions include the full amount of interest on the amount redeemed or is that prorated to the amount of time elapsed until maturity?

好的。謝謝。然後，我想跟進一下，看看您是否可以提供有關融資的更多信息，特別是在嘗試了解您的現金餘額以及未來情況的情況下？您能否詳細解釋一下 11 月 1 日使用的兌換功能如何運作？那麼，贖回是否包括贖回金額的全額利息，還是根據到期時間按比例計算？

So with regard to the convertible debt deal overall, I think as you know, there's a portion of it, which is unrestricted and a portion of it which is restricted. The restricted portion is released upon paying down the initial unrestricted portion and in meeting other financing conditions. And so the process of retiring that initial restricted portion includes the retirement through the redemption and the redemption feature does include the -- your financing charges and interest on top of that.

因此，就整體可轉換債務交易而言，我認為如您所知，其中一部分是不受限制的，一部分是受到限制的。在償還初始非限制部分並滿足其他融資條件後，限制部分將解除。因此，最初受限部分的退休過程包括透過贖回退休，而贖回功能確實包括您的融資費用和利息。

All right. Thank you for that. And then just one last one, I'll hop back in the queue. Regarding the gap fill rate that you got that Praxis and Augusta. How does that compare to the actual cost of materials are running that test?

好的。謝謝你。然後只有最後一件事，我會跳回隊列。關於 Praxis 和 Augusta 的填補空缺率。這與運行該測試的實際材料成本相比如何？

So these are rates and codes that have been obtained by those labs. And so we actually don't know, right? They submitted the application and drove the gap fill. But the standard processes to fully burden their costs and include what would be considered a fair margin. So I suspect that they have a good margin at that rate.

這些是這些實驗室獲得的速率和代碼。所以我們其實不知道，對吧？他們提交了申請並推動了填補空白。但標準流程完全負擔了他們的成本，並包括了被認為是公平的利潤。所以我懷疑他們在這個速度上有很好的利潤。

All right. Thank you very much for answering my question and congrats on the progress this quarter.

好的。非常感謝您回答我的問題，並祝賀本季的進展。

Yeah. Thanks, Michael.

是的。謝謝，麥可。

(Operator Instructions) Sung Ji Nam, Scotiabank.

（操作員指示）Sung Ji Nam，豐業銀行。

Hi. Thanks for taking the questions. Maybe let's see here, kicking off with Stratys. We'd love to hear any feedback you're getting from the early access users and including what type of -- if you're seeing utilizations on the system -- tracking in line with your expectations there? And then do you expect a significant buildup of backlog heading into next year for the full commercial launch?

你好。感謝您提出問題。也許讓我們看看這裡，從 Stratys 開始。我們很想聽聽您從早期訪問用戶那裡得到的任何回饋，包括什麼類型的追蹤（如果您看到系統上的使用率）符合您的期望？那麼，您預計明年全面商業發布的積壓工作是否會大量增加？

Thanks Sung Ji. So it's a little bit early to have concrete feedback from users. So the installations have just begun. And given that it's a brand new instrument, it takes some time for us to even qualify on site. So that process is ongoing.

謝謝宋吉。因此，現在獲得用戶的具體回饋還為時過早。所以安裝才剛開始。由於它是一種全新的樂器，我們甚至需要一些時間才能在現場進行資格認證。所以這個過程正在進行中。

And what I can tell you about, though, is that labs are really focused on bringing on that product. In that, they have identified a variety of use cases that indicate to them that they need the higher throughput that Stratys offers. And so excitement is high and let's hope that Stratys delivers. And we, of course, believe very confidently that it will, and we're excited to have it out in the field.

不過，我可以告訴你的是，實驗室確實專注於開發該產品。在這方面，他們已經確定了各種用例，這些用例表明他們需要 Stratys 提供的更高吞吐量。因此我們非常興奮，希望 Stratys 能夠實現這一目標。當然，我們非常有信心地相信它會實現，並且我們很高興能將其投入使用。

With regard to a backlog into 2024, I only want to say anecdotally that we've had a tremendous response to Stratys that in -- I think many respects, this sees our expectations towards the early access program. So quite a number of labs have raised their hand and asked to be a part of that.

關於 2024 年的積壓，我只想說一句有趣的是，我們對 Stratys 做出了巨大的反應，我認為在很多方面，這都反映了我們對搶先體驗計畫的期望。因此，相當多的實驗室都舉手要求參與其中。

In the event that those requests exceeded the number of early access systems that we have available, which is 10, we believe that they would still be interested in adopting the full commercial model of Stratys. And what we're doing now is managing that transition between one product, the Saphyr system into an environment where we have two products Saphyr and Stratys.

如果這些請求超出了我們可用的搶先體驗系統的數量（10 個），我們相信他們仍然有興趣採用 Stratys 的完整商業模式。我們現在正在做的就是管理 Saphyr 系統這個產品到擁有 Saphyr 和 Stratys 兩種產品的環境之間的過渡。

And this is one of the more tricky path that leadership team, especially a commercial team in this industry has to traverse. And so we're making sure our principle focus is that customers are excited about adopting optical genome mapping and they get the system that's best for them, whether that's Saphyr or Stratys. And so far and based on the guidance that we've provided, we think that we are navigating that transition smoothly.

這是領導團隊，尤其是這個行業的商業團隊必須經歷的更棘手的道路之一。因此，我們確保我們的主要重點是客戶對採用光學基因組作圖感到興奮，並且他們獲得最適合他們的系統，無論是 Saphyr 還是 Stratys。到目前為止，根據我們提供的指導，我們認為我們正在順利過渡。

Great. That's super helpful. And then just on the VIA software launch, just curious if you expect all the customers currently doing hematological research on hematological malignancies to convert over to that. Just curious kind of what you expect from a penetration standpoint?

偉大的。這非常有幫助。然後就在威盛軟體發佈時，我想知道您是否希望目前正在進行血液惡性腫瘤血液學研究的所有客戶都轉向該領域。只是好奇從滲透的角度來看您期望什麼？

Yes. So I think it's reasonable to expect that the vast majority, I mean, substantially all there's going to be that one lab that doesn't want to do it, but substantially all of the labs will convert. The timing of the conversion is a little bit dependent on their progress because a new software would need to be revalidated in some cases, depending on how they're using the platform. And so they will pick the right point in time and perhaps align that revalidation with bringing on other menu items or other applications that they would be running. But for us, the expectation is that everybody adopts. And so we believe that that will be the case.

是的。因此，我認為可以合理地預期絕大多數實驗室，我的意思是，基本上所有實驗室都不想這樣做，但基本上所有實驗室都會轉換。轉換的時間有點取決於他們的進度，因為在某些情況下新軟體需要重新驗證，這取決於他們使用平台的方式。因此，他們將選擇正確的時間點，並可能將重新驗證與引入其他選單項目或他們將運行的其他應用程式保持一致。但對我們來說，期望是每個人都採用。所以我們相信情況會如此。

Got it. And then lastly, from me, on China. Great to see a lot of your OEM customers are gaining traction there. Just curious, you know, given the environment, the macro environment and a lot of the larger cap, both companies and -- seeing increasing headwind in China. Just curious, I would love to hear your perspective from Bionano standpoint, what you're expectations are heading into next year in China?

知道了。最後，我談談中國。很高興看到許多 OEM 客戶在那裡獲得關注。只是好奇，你知道，考慮到環境、宏觀環境和許多更大的上限，兩家公司都看到中國面臨的阻力越來越大。只是好奇，我很想聽聽您從 Bionano 的角度來看，您對明年在中國的期望是什麼？

Yes, it's a good question, and we're watching with great interest, the reports of other companies in this space. What I can tell you is that we reiterated guidance -- full year guidance and that includes sales to China. We've been progressing well.

是的，這是一個很好的問題，我們正在饒有興趣地關注該領域其他公司的報告。我可以告訴你的是，我們重申了指導——全年指導，其中包括對中國的銷售。我們一直進展順利。

And so we're not seeing pressure that would cause us to come off of those numbers. But it's clear that spending on research has seen some headwinds in China. And one of our rationalizations for us thinking that we're going to continue to progress there is that the applications that optical genome mapping get used for there are very, very close to your healthcare applications, clinical research as opposed to academic, and basic research.

因此，我們沒有看到會導致我們放棄這些數字的壓力。但很明顯，中國的研究支出遇到了一些阻力。我們認為我們將繼續在這方面取得進展的合理理由之一是，光學基因組圖譜的應用非常非常接近您的醫療保健應用、臨床研究（而不是學術）和基礎研究。

And so that's why we were comfortable reiterating guidance. Of course, there's a global aspect to the whole revenue mix, but we're mindful of the of the headwinds that others are facing and we're going through China carefully this quarter.

這就是為什麼我們願意重申指導。當然，整個收入組合具有全球性，但我們注意到其他人面臨的阻力，本季我們將仔細研究中國。

Sounds great. Thank you so much.

聽起來很棒。太感謝了。

Thank you, Sung Ji.

謝謝你，宋吉。

(Operator Instructions) Jeffrey Cohen, Ladenburg Thalmann.

（操作說明）Jeffrey Cohen、Ladenburg Thalmann。

Hi Eric and Gülsen. How are you?

嗨，埃里克和古爾森。你好嗎？

We're well, Jeffrey.

我們很好，傑弗裡。

So a few questions from [Aaron]. And so firstly, could you maybe talk about the newer systems that have been placed for Saphyr? Could you tell us what you're seeing as far as sales or leases or per use arrangements as far as any flexibility that you have on the sales front? And is it outright purchase becoming more or less of an obstacle from more recent quarters?

[Aaron] 有幾個問題。首先，您能談談為 Saphyr 設定的新系統嗎？您能否告訴我們您對銷售或租賃或依使用安排以及銷售方面的彈性有何看法？最近幾季以來，直接購買是否或多或少成為了障礙？

So the go to market model for the early access systems, mirrors in many respects what we do for the Saphyr system. And so there's a flexible rental program and the purchase model and the pricing on the purchase is higher. But what we're seeing in terms of the distribution and again, it's early. So the statistical significance of the observations is probably not really well established. But what we're seeing in terms of the distribution is that it's comparable to what we see for the Saphyr system. So some rental and some purchase.

因此，搶先體驗系統的上市模式在許多方面反映了我們為 Saphyr 系統所做的工作。因此，有靈活的租賃計劃和購買模式，並且購買價格更高。但我們從分佈情況來看，現在還為時過早。因此，觀察結果的統計顯著性可能尚未得到很好的證實。但我們所看到的分佈與 Saphyr 系統的分佈相當。所以有的出租，有的購買。

Okay. Got it. And then Gülsen, can you perhaps walk us through some of the commentary as far as the $33 million of savings expected for '24? I guess how we're looking at it, you're talking about a 20% reduction off of SG&A and R&D. When to get outlined perhaps for us where you're going to see some of those savings and perhaps which line item is [see] a more pronounced reduction than the other. Thank you.

好的。知道了。然後，Gülsen，您能否向我們介紹一些有關 24 年預計節省 3300 萬美元的評論？我想我們是如何看待這個問題的，你說的是 SG&A 和 R&D 減少 20%。何時為我們概述您可能會在哪裡看到其中一些節省，也許哪個訂單項目[​​看到]比其他訂單項目的減少更明顯。謝謝。

Thank you, Geffrey. So in terms of the $33 million savings. It is actually some of it is coming from the cost of goods sold area, relatively small -- proportionately small. And as you said, most of it is in R&D and SG&A.

謝謝你，傑弗裡。就節省的 3300 萬美元而言。實際上，其中一部分來自銷售區域的商品成本，相對較小——比例較小。正如您所說，其中大部分是在研發和銷售管理費用方面。

And big part of the savings was actually in announced in our press release, we talked about the headcount reductions. So you can and combined with the ones that we did back in May, a big portion of the savings will come from that area.

大部分節省實際上是在我們的新聞稿中宣布的，我們談到了裁員。因此，結合我們在五月所做的工作，很大一部分節省將來自該領域。

Now, we have looked through every line item on the P&L to see where else we can achieve savings. So it varies, but I don't think there's anything that was untouched. So hard for me to give you the exact guidance, but certainly the majority is from headcount reduction.

現在，我們已經檢查了損益表上的每個項目，看看我們還可以在哪些方面實現節省。所以它有所不同，但我認為沒有什麼是未受影響的。我很難給你確切的指導，但肯定大部分是來自裁員。

Okay. Got it. And then lastly for us, could you give us a sense of pro forma shares and cash, please? I see the queue just hit as well.

好的。知道了。最後，您能為我們介紹一下預計的股票和現金嗎？我看到隊列也剛開始。

Yes, I think it's best if you refer to the cover of the queue and I think we described the cash balance as of [930], which was $63.6 million.

是的，我認為最好參考隊列封面，我認為我們描述了截至 [930] 的現金餘額，為 6360 萬美元。

Perfect Okay. Thanks for taking our questions.

完美 好吧。感謝您回答我們的問題。

Thank you, Jeffrey.

謝謝你，傑弗裡。

(Operator Instructions) [Frank Briswa from Oppenheimer]

（操作員說明）[來自奧本海默的弗蘭克·布里斯瓦]

Hi, this is Dan on for Frank. Thanks for taking my question.

大家好，我是弗蘭克的丹。感謝您提出我的問題。

Just a quick one regarding Stratys, I know you mentioned that it's too early to talk about feedback, but just in terms of the early access program is currently all 10 systems out in the field. And also are all 10 of those users currently where they are already Saphyr users or are they also users who are not?

簡單介紹一下 Stratys，我知道您提到現在談論反饋還為時過早，但僅就早期訪問計劃而言，目前所有 10 個系統都已投入使用。另外，這 10 名用戶目前是否已經是 Saphyr 用戶，還是還不是 Saphyr 用戶？

So hi, Dan. What I can say is that we -- all 10 are not out in the field and that's not a demand issue. It's just based on our production timeline. So when we produce them, they go out.

嗨，丹。我能說的是，我們——所有 10 個人都沒有在現場，這不是需求問題。這只是基於我們的生產時間表。所以當我們生產它們時，它們就會出去。

With regard to the composition of users, what we see now and this is actually really important. Is that the majority of folks who are coming on board to adopt Stratys are new customers. And I think that that's a little bit of a unique component in this kind of a product cycle within the industry. And it's good.

關於用戶的組成，我們現在看到的這一點其實非常重要。大多數採用 Stratys 的人都是新客戶。我認為這是行業內此類產品週期中的一個獨特組成部分。這很好。

We introduced. I mean, we developed the Stratys to address a segment of the market that was excited about optical genome mapping and the value that it brings to them. But unable to really implement it because of the throughput limitations that the current Saphyr has.

我們介紹了。我的意思是，我們開發 Stratys 是為了滿足對光學基因組圖譜及其給他們帶來的價值感到興奮的細分市場的需求。但由於目前 Saphyr 的吞吐量限制，無法真正實現它。

And so when we start to see folks raising their hands to adopt Stratys and that they're new customers. What the connection there is that they actually have higher volume utilization plans for OGM in their labs. So I think that indicates that we developed the right product for a segment of the market that were not yet penetrated.

因此，當我們開始看到人們舉手採用 Stratys 並且他們是新客戶時。其中的關聯是，他們實際上在實驗室中製定了更高的 OGM 容量利用率計劃。因此，我認為這表明我們為尚未滲透的細分市場開發了正確的產品。

Now over time, I think we will see the conversion of Saphyrs' to Stratys systems. But and the purpose of Stratys is to really bring in new customers, new users and who are currently on the sidelines.

現在，隨著時間的推移，我認為我們將看到 Saphyrs 系統向 Stratys 系統的轉換。但是，Stratys 的目的是真正引入新客戶、新用戶以及目前觀望的人。

Okay. And last one for me. You started the call highlighting the Human Genetics conference that you attended. Could you give us a sense of the feedback from that compared to say a year ago? Would you say there is a notable increase in the labs presentations that included the OGM this time around.

好的。最後一張給我。您在通話開始時強調了您參加的人類遺傳學會議。您能為我們介紹一下與一年前相比的回饋嗎？您是否認為這次包括 OGM 在內的實驗室演示有顯著增加？

And also related to that, any particular area that you're noticing increased OGM adoption application, say rare diseases where you're seeing an increase in publications, basic versus clinical research? Any color there?

與此相關的是，您注意到 OGM 採用應用程式增加的任何特定領域，例如您看到出版物、基礎研究與臨床研究增加的罕見疾病？那裡有什麼顏色嗎？

Yeah. So ASHG is really one of the premier meetings, conferences around the world takes place every year around this time in the fall. And ASHG is somewhat differentiated from others in that it has a heavy orientation towards research, but there's a lot of clinical folks there as well.

是的。因此，ASHG 確實是最重要的會議之一，世界各地的會議每年都會在秋季的這個時候舉行。 ASHG 與其他機構有所不同，因為它非常注重研究，但也有很多臨床人員。

And I would say that if we compare the presence of optical genome mapping in that environment this year to that of last year. What I think is and of course, this is anecdotal based on my observations, but I've reviewed those observations from all of our folks who are there. The observation is that we are really in the regular conversation of techniques that are intended to be used throughout clinical translational research.

我想說的是，如果我們將今年該環境中光學基因組圖譜的存在與去年進行比較。我的想法是，當然，這是基於我的觀察的軼事，但我已經回顧了我們所有在場人員的這些觀察。觀察結果是，我們確實正在定期討論旨在用於整個臨床轉化研究的技術。

And the kinds of clinical translational research that we're talking about here are the understanding of genetic diseases. Now that may be in a workflow where a patient gets tested and subsequently enrolled in a research program because the standard of care didn't really reveal any useful information that happens about half the time by the way. So that's the research that's going on.

我們在這裡討論的臨床轉化研究是對遺傳疾病的理解。現在，這可能是在一個工作流程中，患者接受測試並隨後參加研究項目，因為護理標準並沒有真正揭示任何有用的信息，順便說一下，大約有一半的時間發生。這就是正在進行的研究。

The other research that's going on is to really use optical genome mapping to explain very complex disorders. An example that came up in our meeting was neural tube defects, things like spina bifida and other disorders. And the genetics of these diseases are incredibly poorly understood. And what's amazing is that optical genome mapping as unlocking an incredible new understanding, why is that important therapeutic applications? So treatment of these disorders can be developed on the basis of this new information.

正在進行的另一項研究是真正使用光學基因組圖譜來解釋非常複雜的疾病。我們會議上提到的一個例子是神經管缺陷、脊柱裂和其他疾病。人們對這些疾病的遺傳學知之甚少。令人驚訝的是，光學基因組圖譜解鎖了令人難以置信的新認識，為什麼它是重要的治療應用？因此，可以根據這些新資訊開發這些疾病的治療方法。

And so an abundance of these types of presentations, posters, talks some of them in Bionano sessions that we organize by amazingly as part of the regular program. We see optical genome mapping featured very prominently.

因此，我們在 Bionano 會議上進行了豐富的此類演示、海報和一些討論，這些會議是我們作為常規計劃的一部分組織的，令人驚嘆。我們看到光學基因組圖譜非常突出。

So our observation is that with regard to that community optical genome mapping is really part of the mainstream. And if you compare that to a year ago, it was just beginning. I think a year ago there was a dedicated session in the regular program to optical genome mapping, but it was something that was really new.

所以我們的觀察是，關於社區光學基因組圖譜確實是主流的一部分。如果與一年前相比，一切才剛開始。我想一年前，在光學基因組圖譜常規計劃中有一個專門的會議，但它確實是新的東西。

And the last thing that I'll comment on is that there were a number of important publications that are intended to represent industry wide views. So the Thompson & Thompson genetics and genomics manual, which came out earlier in the year. This was something that we were able to talk about and the inclusion of optical genome mapping into that edition, the 9th edition, it's really a step forward around the awareness of what we're doing.

我要評論的最後一件事是，有許多重要的出版物旨在代表整個行業的觀點。今年稍早出版的 Thompson & Thompson 遺傳學和基因組學手冊。這是我們能夠討論的事情，並將光學基因組圖譜納入該版本，即第 9 版，這確實是圍繞我們正在做的事情的認識向前邁出的一步。

And then there was a rather significant review publication that came out right around the time of the start of the meeting, and it was written by many, many preeminent scientists and researchers who really set the tone for that entire community. And this is an extensive publication that covers not only optical genome mapping, of course, but all of the different methods.

然後，在會議開始時出版了一份相當重要的評論出版物，它是由許多傑出的科學家和研究人員撰寫的，他們真正為整個社區定下了基調。當然，這是一本內容廣泛的出版物，不僅涵蓋光學基因組圖譜，還涵蓋所有不同的方法。

And when you look at publications like that, they're starting to spell out algorithms that discuss the use of optical genome mapping alongside all the other tools. So the reason that, that kind of advancement is so incredibly important is that when Bionano commercial teams goes to a lab and says, hi, I'm here to talk to you about optical genome mapping a year ago. The question that they would get is where does optical genome mapping fit in my lab and what should I do with it. But now after all of these publications, the understand the answers to those questions before we meet them. It's a huge leap forward for us.

當你看這樣的出版物時，他們開始詳細闡述討論光學基因組圖譜與所有其他工具的使用的演算法。因此，這種進步如此重要的原因是，當 Bionano 商業團隊去實驗室說，嗨，一年前我來這裡是為了和你們談論光學基因組圖譜。他們會得到的問題是光學基因組圖譜適合我的實驗室的什麼位置以及我應該用它做什麼。但現在，在所有這些出版物發布之後，我們在遇到這些問題之前就了解了這些問題的答案。這對我們來說是一個巨大的飛躍。

So thanks for giving me a chance to talk about it.

所以感謝你給我機會談論這個問題。

Thank you. That's very encouraging. Thanks for taking my questions.

謝謝。這非常令人鼓舞。感謝您回答我的問題。

Thank you. And there are no further questions at this time, I would like to turn the conference back to Erik Holmlin, CEO for closing remarks.

謝謝。目前沒有其他問題了，我想請執行長 Erik Holmlin 致閉幕詞。

Thanks, Kyle. I appreciate everyone joining here today. We're excited to finish out this fourth quarter and then share with you the results after the end of the year and our full year call. So thank you very much for joining today.

謝謝，凱爾。我感謝今天來到這裡的大家。我們很高興能夠完成第四季度的工作，然後在年底和全年電話會議後與您分享結果。非常感謝您今天的加入。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。