Bionano Genomics Inc (BNGO) 2024 Q2 法說會逐字稿

Good day, and thank you for standing by.

美好的一天，感謝您的支持。

Welcome to the Bionano Q2 financial results call.

歡迎參加 Bionano 第二季度財務業績電話會議。

(Operator Instructions) Please be advised that today's conference is being recorded.

（操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, David Holmes, Investor Relations.

我現在想把會議交給今天的演講者、投資者關係部的大衛‧霍姆斯 (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 second quarter 2024 financial results conference call.

歡迎參加 Bionano 2024 年第二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 second quarter of 2024.

今天收盤後，Bionano 發布新聞稿，宣布 2024 年第二季財務業績。

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。

Certain statements made during this conference call may be forward-looking statements, including statements about Bionano's revenue outlook, profitability, cash runway, cost savings initiatives and commercialization and product plans.

本次電話會議期間所做的某些陳述可能是前瞻性陳述，包括有關 Bionano 的收入前景、盈利能力、現金跑道、成本節約計劃以及商業化和產品計劃的陳述。

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

此類陳述基於目前的預期，不能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 reports filed 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在 Bionano 的新聞稿和 Bionano 向 SEC 提交的報告中已確定。

These forward-looking statements are based on information available to Bionano today, August 7, 2024, and the company assumes no obligation to update statements as circumstances change.

這些前瞻性陳述是基於 Bionano 今天（2024 年 8 月 7 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 reported certain non-GAAP financial measures.

除了補充 Bionano 根據美國公認會計原則 (GAAP) 報告的財務表現外，該公司還報告了某些非 GAAP 財務指標。

A description of these non-GAAP financial measures, as well as a reconciliation to the nearest GAAP financial measures 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.

今天稍早發布的公司收益報告的末尾包含了對這些非公認會計原則財務指標的描述，以及與最接近的公認會計原則財務指標的調節，該報告已發佈在公司網站的投資者關係頁面上。

These non-GAAP financial measures are 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, 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。

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。

With that, I would like to turn the call over to Erik.

說到這裡，我想把電話轉給艾瑞克。

Thank you, David, and good afternoon, everyone.

謝謝大衛，大家下午好。

Q2 2024 was significant for the progress made towards the worldwide acceptance of OGM, and it's also the quarter where the majority of staffing reductions conducted to our cost savings initiatives took effect, which means we're learning how to operate within a streamlined team.

2024 年第二季度對於 OGM 在全球範圍內的接受度方面取得了重大進展，也是我們為節省成本計劃而進行的大部分人員削減生效的季度，這意味著我們正在學習如何在精簡的團隊中運作。

I also think it's important to acknowledge that in the midst of our solid execution, we are facing a challenging and turbulent economic backdrop.

我還認為重要的是要承認，在我們紮實的執行過程中，我們面臨著充滿挑戰和動盪的經濟背景。

This challenge includes the broader equity capital markets and limitations to the financing options available to us.

這項挑戰包括更廣泛的股權資本市場以及我們可用的融資選擇的限制。

But I want to underscore that while management is frustrated by these challenges, our focus remains on moving OGM forward.

但我想強調的是，雖然管理階層對這些挑戰感到沮喪，但我們的重點仍然是推動 OGM 向前發展。

And with that, I want to start off the call today by discussing the recent decision of the editorial panel of the American Medical Association or AMA, to accept the application for a Category 1 CPT code for the use of optical genome mapping in cytogenomic genomewide analysis to the structural and copy number variations related to hematological malignancies.

因此，我想在今天的電話會議上首先討論美國醫學會 (AMA) 編輯小組最近的決定，即接受 1 類 CPT 代碼的申請，以便在細胞基因組全基因組分析中使用光學基因組圖譜與血液惡性腫瘤相關的結構和拷貝數變異。

We believe the CPT code will enable the adoption and utilization of OGM to increase significantly.

我們相信 CPT 代碼將使 OGM 的採用和利用率顯著增加。

It's a key component that labs can leverage to obtain reimbursement from insurance companies and Medicare when they use optical genome mapping for clinical testing.

當實驗室使用光學基因組圖譜進行臨床測試時，它是實驗室可以利用從保險公司和醫療保險獲得報銷的關鍵組成部分。

And that includes, of course, the reimbursement of OGM-Dx Team-1, our laboratory-developed test offered by Bionano Laboratories.

當然，這包括 OGM-Dx Team-1 的報銷，這是我們由 Bionano Laboratories 提供的實驗室開發的測試。

And importantly, given that the criteria used by the AMA for Category 1 CPT code approval is rigorous and includes input from stakeholders across the healthcare community.

重要的是，鑑於 AMA 用於 1 類 CPT 代碼批准的標準非常嚴格，並且包括整個醫療保健界利益相關者的意見。

We view the decision to establish a code for OGMs indirectly reflecting OGMs increasing maturity and utility.

我們認為建立 OGM 程式碼的決定間接反映了 OGM 的成熟度和實用性的提升。

It's a really significant milestone for us and for users of OGM and we're very proud of the outcome and we're seeing a positive benefit already.

對於我們和 OGM 使用者來說，這是一個非常重要的里程碑，我們對結果感到非常自豪，我們已經看到了積極的效益。

Now, I'd like to give an overview of the quarter.

現在，我想概述一下本季的情況。

Revenue for the quarter was $7.8 million, and that includes $700,000 of revenues associated with clinical services, which we have previously discontinued.

本季收入為 780 萬美元，其中包括與臨床服務相關的 70 萬美元收入，而我們之前已經停止了該服務。

The second quarter 2024 revenue represents a 10% year-over-year decrease compared to the same period of 2023, but keep in mind, that includes a 53% reduction in revenues tied to these discontinued clinical services.

與 2023 年同期相比，2024 年第二季的營收年減 10%，但請記住，其中包括與這些已停止的臨床服務相關的收入減少 53%。

The OGM installed base grew to 363 systems during Q2, representing a net increase of 16 systems and 29% growth over the installed base at the end of the second quarter of 2023.

第二季 OGM 安裝量增加至 363 個系統，淨增加 16 個系統，比 2023 年第二季末的安裝量增加 29%。

We sold 6,165 flow cells in the second quarter of 2024, which represents a year-over-year decrease of 13% compared to the 7,062 flow sales sold in the same period last year.

我們在 2024 年第二季銷售了 6,165 個流通池，與去年同期銷售的 7,062 個流通池相比，年減了 13%。

In fact, this quarter is the first in 20 consecutive quarters, where flow cells sold declined on a year-over-year basis.

事實上，本季是連續 20 個季度中流通池銷量首次年減。

Looking into that result a little bit more, we see that in Europe, flow sales sold grew in the quarter.

進一步研究該結果，我們發現在歐洲，本季的流量銷售有所成長。

But in the Americas and in the Asia Pacific region, the number of flow cells sold declined.

但在美洲和亞太地區，流通池的銷量有所下降。

The decline relative to the second quarter of 2023 was most significant on a percentage basis in China.

從百分比來看，相對 2023 年第二季的下降在中國最為顯著。

And that's been driven by our OEM partners and key customers falling behind on their committed or expected purchases in the quarter.

這是由我們的 OEM 合作夥伴和主要客戶未能兌現本季承諾或預期採購所造成的。

We estimate that this shortfall was approximately 1,200 flow cells.

我們估計缺口約 1,200 個流通池。

This underperformance in China is a function of both the slowdown in funding for companies in the region, which has been well publicized and well-known, it's also a function of the fact that our OEM partners are awaiting approval from the National Medical Products Administration or NMPA of China to evaluate Saphyr systems there, so that they can be sold directly into hospitals under a clinical intended use designation.

中國的表現不佳既是因為該地區公司的融資放緩（這一點已廣為人知且眾所周知），也是因為我們的 OEM 合作夥伴正在等待國家醫療產品管理局或其他國家的批准。在那裡評估Saphyr 系統，以便它們能夠以臨床預期用途指定直接銷售給醫院。

We see the potential for this delay in China business to persist, and that's something that we factored into guidance for Q3 and for the full year.

我們認為中國業務的這種延遲有可能持續下去，這是我們在第三季和全年的指導中考慮的因素。

Now regarding the decline in the Americas region, we see two factors coming into play.

現在，關於美洲地區的衰退，我們看到有兩個因素在發揮作用。

One is for existing Saphyr sites that have adopted Stratys, where we've seen a slowdown in their expected purchases, which we attribute to the process of transitioning from one system to the other.

其中之一是針對已採用 Stratys 的現有 Saphyr 站點，我們發現他們的預期購買量有所放緩，我們將其歸因於從一種系統過渡到另一種系統的過程。

This effect is something we think we can mitigate going forward with additional Stratys sites by helping them plan the transition in advance.

我們認為，透過幫助其他 Stratys 站點提前規劃過渡，可以減輕這種影響。

The second is the impact of the reduction of force connected to our cost savings initiative, which has reduced the number of field sales and support team that would normally shepherd these processes forward.

第二個是與我們的成本節約計畫相關的人員減少的影響，這減少了通常引導這些流程前進的現場銷售和支援團隊的數量。

Overall, for the first half of 2024, the total number of flow cells sold were up 17%, and we are expecting a strong third quarter as we adjust to these new staffing levels.

總體而言，2024 年上半年，流通池銷售總數成長了 17%，隨著我們適應這些新的人員配置水平，我們預計第三季將表現強勁。

Some key highlights in other areas of the business include a Software Marketing Agreement into which we entered with Revvity, under which Revvity will market and commercialize our VIA software as part of its Newborn Sequencing Research workflow.

其他業務領域的一些關鍵亮點包括我們與 Revvity 簽訂的軟體行銷協議，根據該協議，Revvity 將行銷和商業化我們的 VIA 軟體，作為其新生兒定序研究工作流程的一部分。

Publications grew.

出版品增長。

With 72 publications in Q2, the total number of publications from the first half of 2024 grew by 37% compared to the same period in 2023.

第二季共發表 72 篇論文，2024 年上半年的論文總數較 2023 年同期成長 37%。

The total number of clinical research subjects covered in publications in the first half of 2024 has grown by 136% from the same period in 2023.

2024年上半年出版品涵蓋的臨床研究主題總數較2023年同期成長了136%。

And in July, a peer-reviewed publication on the first phase of our prenatal multisite study was published, which showed for 200 samples or 123 unique cases that OGM's overall accuracy was 99.6%.

7 月，我們發表了一份關於我們產前多站點研究第一階段的同行評審出版物，該出版物顯示，對於 200 個樣本或 123 個獨特病例，OGM 的總體準確率為 99.6%。

Its sensitivity was 99.5%, specificity was 100% as was PPV at 100%, and the Negative Predictive Value or NPV was 95.5%.

其敏感度為 99.5%，特異性為 100%，PPV 為 100%，陰性預測值或 NPV 為 95.5%。

Additionally, OGM was 100% reproducible between sites, operators, and instruments.

此外，OGM 在站點、操作員和儀器之間具有 100% 的可重複性。

We have continued to ship commercial production units of the Stratys system and the ongoing feedback around Stratys continues to be positive.

我們繼續交付 Stratys 系統的商業生產單元，並且圍繞 Stratys 的持續反饋仍然是積極的。

And we also released a series of major advancements to our entire suite of comprehensive analysis software tools for cancer, including Version 7.1 of our VIA software.

我們也發表了整套癌症綜合分析軟體工具的一系列重大改進，包括 VIA 軟體的 7.1 版。

These advancements enhance the detection and interpretation of angiosomes, which are important in cancer, and improve the analysis, visualization, interpretation, and reporting of data types, including optical genome mapping, next-generation sequencing or NGS as well as microarrays.

這些進步增強了血管小體的檢測和解釋，這在癌症中很重要，並改進了數據類型的分析、視覺化、解釋和報告，包括光學基因組圖譜、下一代定序或NGS以及微陣列。

Before looking ahead to the remainder of 2024 and our expectations, I would like to turn the call over to Gulsen, who will walk you through the financial results.

在展望 2024 年剩餘時間和我們的預期之前，我想將電話轉給 Gulsen，他將向您介紹財務表現。

Gulsen?

古爾森？

Thanks, Erik.

謝謝，埃里克。

As Erik mentioned, revenue for the quarter was $7.8 million. GAAP

正如 Erik 所提到的，該季度的收入為 780 萬美元。公認會計原則

gross margin for the second quarter was 33% compared to 27% during Q2 2023 and non-GAAP gross margin was 35% compared to 29% in the same quarter last year.

第二季的毛利率為 33%，而 2023 年第二季為 27%；非 GAAP 毛利率為 35%，而去年同期為 29%。

Second Quarter 2024 GAAP operating expense was $19.6 million and non-GAAP operating expense was $18.8 million.

2024 年第二季 GAAP 營運費用為 1,960 萬美元，非 GAAP 營運費用為 1,880 萬美元。

These reflect decreases of 53% and 46%, respectively from the second quarter of 2023.

與 2023 年第二季相比分別下降了 53% 和 46%。

Our cash, cash equivalents and available-for-sale securities as of June 30, 2024, were $30.3 million, of which $11.4 million was subject to certain restrictions.

截至 2024 年 6 月 30 日，我們的現金、現金等價物及可供出售證券為 3,030 萬美元，其中 1,140 萬美元受到某些限制。

Regarding financing activity in the second quarter and subsequently, we have completed two registered direct offerings and restructured our debt.

關於第二季及隨後的融資活動，我們完成了兩次註冊直接發行並重組了我們的債務。

In April 2024, we completed a $10 million registered direct offering, which resulted in $9.3 million of net proceeds to the company after deducting the placement agents, fees, and other offering expenses.

2024 年 4 月，我們完成了 1000 萬美元的註冊直接發行，扣除配售代理、費用和其他發行費用後，公司獲得了 930 萬美元的淨收益。

In May, we completed a private placement of senior secured convertible debentures due May 2026, which resulted in gross proceeds of $18 million.

5 月，我們完成了 2026 年 5 月到期的優先擔保可轉換債券的私募，募集資金總額為 1,800 萬美元。

Concurrently, we retired the outstanding balance of the convertible debt, which we entered into in October of 2023.

同時，我們還清了 2023 年 10 月簽訂的可轉換債務的未償餘額。

As of June 30, 2024, the aggregate principal amount of senior secured convertible debentures outstanding was $20 million.

截至 2024 年 6 月 30 日，未償還優先有擔保可轉換債券的本金總額為 2,000 萬美元。

The structure of the new debt provided us with significant financial flexibility by retiring near term debt maturities and deferring principal redemption payments.

新債務的結構透過償還近期債務到期日和延遲本金贖回付款，為我們提供了顯著的財務靈活性。

In July, we completed another registered direct offering with upfront gross proceeds to the company of $10 million and a concurrent private placement of clinical milestone linked Series A and Series B warrants.

7 月，我們完成了另一項註冊直接發行，向公司預付總收益 1000 萬美元，並同時私募了與臨床里程碑相關的 A 系列和 B 系列認股權證。

Warrants have potential additional gross proceeds of up to $20 million if exercised for cash and are exercisable only upon stockholder approval.

如果以現金方式行使，認股權證的潛在額外總收益高達 2000 萬美元，並且只有在股東批准後才能行使。

We will be filing a proxy statement for a special meeting of stockholders that we expect to be held in early October.

我們將為預計於 10 月初舉行的股東特別會議提交委託書。

Back to you, Erik.

回到你身邊，艾瑞克。

Thanks, Gulsen.

謝謝，古爾森。

Looking ahead to Q3 and to the remainder of the year, our focus is on balancing the need on the one hand to reduce expenses and operate with fewer employees with on the other, the need to realize the full potential value in converting traditional cytogenetics to OGM.

展望第三季和今年剩餘時間，我們的重點是平衡一方面需要減少開支和減少員工運營，另一方面需要實現將傳統細胞遺傳學轉變為 OGM 的全部潛在價值。

Regarding expenses, we began reducing them in May of 2023, and that continued in October of 2023, and then in March of 2024.

關於費用，我們從 2023 年 5 月開始減少，並持續到 2023 年 10 月，然後是 2024 年 3 月。

Our plan was to reduce annualized non-GAAP expenses relative to the annualized non-GAAP operating expense in March of 2023 by a total of $65 million to $75 million.

我們的計畫是相對於 2023 年 3 月的年度化非 GAAP 營運費用，將年度化非 GAAP 費用減少總計 6,500 萬美元至 7,500 萬美元。

The savings are expected to be fully realized in the first quarter of 2025 and we're progressing well toward this goal as is evident in the 46% or $15.8 million reduction in non-GAAP operating expenses in the second quarter of 2024, compared to the same period a year ago.

預計這些節省將在2025 年第一季完全實現，並且我們正在朝著這一目標進展順利，這一點可以從2024 年第二季度非GAAP 運營費用比2024 年第二季度減少46% 或1,580 萬美元中看出。

In addition to those initiatives, management will remain vigilant toward further streamlining our operations and extending the savings.

除了這些舉措之外，管理層還將保持警惕，進一步簡化我們的營運並擴大節省。

And we recognize, as we do this, it has the potential to impact future results.

我們認識到，當我們這樣做時，它有可能影響未來的結果。

And so that's something that we will pay close attention to.

所以這是我們將密切關注的事情。

We are still in the process of adapting to our streamlined operational model, and it may be partially to blame for not being able to overcome some of the challenges we face in China and other areas of the business this quarter.

我們仍在適應精簡的營運模式，這可能是我們本季無法克服我們在中國和其他業務領域面臨的一些挑戰的部分原因。

Our management team continues to focus on shoring up any gaps in commercial execution and other areas of the business that might be coming from organizational change.

我們的管理團隊繼續專注於彌補商業執行和其他業務領域可能因組織變革而產生的差距。

Our efforts to continue driving growth include planned advancements to the workflow and ongoing efforts in market development to support reimbursement.

我們繼續推動成長的努力包括計劃改進工作流程以及持續努力開發市場以支持報銷。

We have additional important advancements that are slated for this year.

今年我們計劃取得更多重要進展。

In the fourth quarter, we plan to release improvements to the data analysis processing time on the Stratys compute system, which is a high-performance computational workstation, developed in collaboration with NVIDIA to support higher sample throughput for our customers.

在第四季度，我們計劃發布對 Stratys 運算系統資料分析處理時間的改進，該系統是與 NVIDIA 合作開發的高效能運算工作站，旨在為我們的客戶提供更高的樣本吞吐量。

We are addressing the DNA isolation challenges that come with optical genome mapping using isotachophoresis technology on the Ionic system.

我們正在 Ionic 系統上使用等速電泳技術來解決光學基因組作圖帶來的 DNA 分離挑戰。

We have completed precommercial evaluation of OGM on the Ionic system with a newly developed isotachophoresis cartridge, which is specific for isolation of ultrahigh molecular weight DNA at two different sites, and a third is currently underway.

我們已經使用新開發的等速電泳墨盒完成了 Ionic 系統上 OGM 的商業前評估，該墨盒專門用於在兩個不同位點分離超高分子量 DNA，第三個目前正在進行中。

Feedback on this new workflow has been positive and it includes a validation of Ionic's ability to reduce OGM sample to answer workflow to as few as two days.

這個新工作流程的回饋是正面的，它包括對 Ionic 能夠將 OGM 樣本回答工作流程縮短至短短兩天的能力的驗證。

We're planning a full commercial release of the product later in the year, likely in the fourth quarter, and we believe the enhancements to the Stratys compute and Ionic will enable more samples to be processed by labs using the same number of technicians.

我們計劃在今年稍後（可能是第四季度）推出該產品的完整商業版本，我們相信 Stratys 計算和 Ionic 的增強功能將使實驗室能夠使用相同數量的技術人員處理更多的樣本。

Our clinical studies program is really focused on advancing the Heme trial and supporting continuing publication of more pre- and postnatal study data from the constitutional trials like the publication that appeared this July.

我們的臨床研究計畫的真正重點是推進血紅素試驗，並支持繼續發表更多來自體質試驗的產前和產後研究數據，例如今年 7 月發表的出版物。

In fact, relating to the Heme trial and a preliminary readout Dr. Phillip Michaels from Harvard Medical School presented interim results this week at the Cancer Genomics Consortium meeting in St. Louis.

事實上，與血紅素試驗相關的初步結果來自哈佛醫學院的 Phillip Michaels 博士本週在聖路易斯舉行的癌症基因組學聯盟會議上公佈了中期結果。

The data showed that optical genome mapping detected pathogenic findings in 42% of cases that were otherwise negative when they were evaluated by standard of care testing such as karyotyping and fluorescence in situ hybridization or

數據顯示，光學基因組圖譜在 42% 的病例中檢測到了致病性結果，而當透過核型分析和螢光原位雜交或螢光原位雜交等標準護理測試進行評估時，這些結果呈陰性。

[FISH].

[魚]。

The turnaround time of optical genome mapping from sample to report was four days and the cost was lower than karyotyping alone, and so clearly lower than the combination of karyotyping and FISH.

光學基因組作圖從樣本到報告的周轉時間為四天，成本低於單獨核型分析，因此明顯低於核型分析和 FISH 組合的成本。

So this is incredible progress that we're seeing and we will continue to invest in the Heme trial going forward.

因此，這是我們所看到的令人難以置信的進展，我們將繼續投資於血紅素試驗。

And with regard to guidance for the remainder of the year, we remain on track to meet our goal of installing 381 of having an installed base of 381 to 401 OGM systems by the end of 2024.

關於今年剩餘時間的指導，我們仍有望實現到 2024 年底安裝 381 個 OGM 系統的目標，即安裝基礎為 381 至 401 個 OGM 系統。

And this reflects some upgrades of Saphyr to Stratys in the process.

這反映了 Saphyr 到 Stratys 過程中的一些升級。

We expect the third quarter revenues to be in the range of $7.9 million to $8.9 million.

我們預計第三季營收將在 790 萬美元至 890 萬美元之間。

And given the slowdown that we're experiencing in China, we expect our full-year revenues to end up at the lower end of the range given previously, and therefore, we're adjusting our full-year 2024 revenue guidance to be $36 million to $40 million down from $37 million to $41 million.

鑑於我們在中國經歷的經濟放緩，我們預計我們的全年收入最終將達到之前給出的範圍的下限，因此，我們將 2024 年全年收入指導調整為 3600 萬美元從3700 萬美元降至4100萬美元，降至4000 萬美元。

And we understand that we may see some slower growth in the adoption and expansion of optical genome mapping as a result of further expense reductions.

我們知道，由於費用進一步減少，光學基因組圖譜的採用和擴展可能會出現一些緩慢的增長。

But we believe that cash preservation and profitability are more and more in targets than growth at any cost.

但我們認為，現金保值和獲利能力越來越成為目標，而不是不惜一切代價實現成長。

In closing, I'm pleased with the progress we have made in the first half of 2024, and we remain committed to disciplined cash management and running an efficient organization and we continue to believe that we will transform the field of cytogenetics with optical genome mapping.

最後，我對我們在 2024 年上半年的進展感到高興，我們仍然致力於嚴格的現金管理和運營高效的組織，我們仍然相信我們將透過光學基因組圖譜改變細胞遺傳學領域。

And so operator, with that, please go ahead and open the line for questions.

接線員，請繼續撥打電話提問。

(Operator Instructions) Jeff Cohen, Ladenburg Thalmann and Co.

（操作員說明）Jeff Cohen，Ladenburg Thalmann and Co.

Hi, this is actually Destiny on for Jeff.

嗨，這實際上是傑夫的命運。

I just had a couple of quick questions.

我只是有幾個簡單的問題。

In regards to your lower guidance, is that -- is that mostly based on this lesser staffing?

關於您的較低指導，主要是基於人員配置的減少嗎？

I guess what I want to know is what portion of that is really attributable to lower head count and what part of that is attributable to the transition to the Stratys system?

我想我想知道的是，其中哪一部分真正歸因於人員數量減少，哪一部分歸因於向 Stratys 系統的過渡？

Yeah.

是的。

I mean, I think we shifted the range down by $1 million.

我的意思是，我認為我們將範圍下調了 100 萬美元。

Thank you, Destiny, for the question.

謝謝命運的提問。

And if you kind of look at the underperformance of China, it probably accounts for that shift.

如果你看看中國的表現不佳，你會發現這可能是造成這種轉變的原因。

And so we're anticipating the possibility that China continues to underperform over the remainder of the year.

因此，我們預計中國在今年剩餘時間內可能會繼續表現不佳。

So I think the China underperformance, not catching up is probably the first and most definitive driver.

所以我認為中國表現不佳、沒有趕上可能是第一個也是最決定性的驅動因素。

I'm not really shifting guidance in connection with some of these full year guidance in connection with some of these other effects because I feel like those are more transient and can be ironed out over the remainder of the year.

我並沒有真正改變與其中一些全年指導和其他一些影響相關的指導，因為我覺得這些影響更為短暫，可以在今年剩餘時間內解決。

Okay.

好的。

All right.

好的。

That makes sense.

這是有道理的。

And then I just was wondering, what are some of the broader implications of the results from the multisite study in multiple myeloma?

然後我只是想知道，多發性骨髓瘤多中心研究的結果有哪些更廣泛的意義？

And how would you say you're planning to leverage these findings to advance other product offerings and expand within the market in general?

您打算如何利用這些發現來推進其他產品供應並在整個市場內擴張？

Yeah.

是的。

Okay.

好的。

So I want to be clear on a couple of things.

所以我想澄清一些事情。

So there's a really outstanding publication that came out in the quarter covering multiple myeloma, and that's not something that I spoke about here in the scripts per se, I spoke about our multisite study, which is addressing hematologic malignancies across the Board.

因此，本季度出版了一份非常出色的出版物，涵蓋了多發性骨髓瘤，這不是我在腳本本身中談到的內容，我談到了我們的多站點研究，該研究正在全面解決血液系統惡性腫瘤問題。

But let me talk about multiple myeloma because it's in a really important indication.

但讓我來談談多發性骨髓瘤，因為它是一個非常重要的適應症。

And that publication that came out is key.

出版的出版物是關鍵。

And so multiple myeloma is a significant form of hematologic malignancy, and one of its characteristics is that there are effective treatments for canonical multiple myeloma, but the cell type tends to be refractory to cell growth in the lab.

因此，多發性骨髓瘤是血液系統惡性腫瘤的一種重要形式，其特徵之一是對典型的多發性骨髓瘤有有效的治療方法，但細胞類型往往難以在實驗室中生長。

Cell growth is required to perform standard-of-care testing, karyotyping, for example.

例如，細胞生長是進行標準護理測試、核型分析所必需的。

It's a multiple myeloma is an indication where an alternative that does not rely on cell growth and cell culture would be very powerful.

這是一種多發性骨髓瘤，顯示不依賴細胞生長和細胞培養的替代方案將非常有效。

And so when you look at this study in multiple myeloma, where the results are really significant.

因此，當您查看這項針對多發性骨髓瘤的研究時，您會發現結果非常重要。

I think it means that there is the potential and certainly, we believe in this potential that labs can not only adopt optical genome mapping for other leukemias like AML, ALL, CML, CLL, but also for multiple myeloma.

我認為這意味著有潛力，當然，我們相信這種潛力，實驗室不僅可以採用光學基因組圖譜來治療其他白血病，如 AML、ALL、CML、CLL，還可以用於治療多發性骨髓瘤。

So it really expands the opportunity for adoption or for existing sites to grow their utilization.

因此，它確實擴大了採用或現有站點提高利用率的機會。

That's really significant in the multiple myeloma results because it's a new indication within hematological malignancies.

這對於多發性骨髓瘤結果非常重要，因為它是血液惡性腫瘤的新適應症。

When we look at the trial results that were presented on a preliminary basis at this conference, those trial results are significant because they start to get at the fundamental health economic, and outcome benefits of optical genome mapping being used in a clinical setting.

當我們查看本次會議上初步提出的試驗結果時，這些試驗結果意義重大，因為它們開始了解光學基因組圖譜在臨床環境中使用的基本健康經濟學和結果效益。

And so those benefits are being quantified in this study and are going to play key roles in insurance coverage decisions that will be made in the next 9 months, 12 months, 18 months.

因此，這些福利將在本研究中進行量化，並將在未來 9 個月、12 個月、18 個月內做出的保險承保決策中發揮關鍵作用。

And so we've seen that most of our trial study results have gotten at things like does OGM work as well as the standard of care, and now these trial results are getting to say, well, it works as well as but how much better and not only how much better but how many study subjects or patients are impacted by those results.

因此，我們已經看到，我們的大多數試驗研究結果都涉及 OGM 是否有效以及護理標準等問題，現在這些試驗結果表明，嗯，它也有效，但好多少不僅是改善了多少，還有有多少研究對像或患者受到這些結果的影響。

So both are very significant.

所以兩者都是非常有意義的。

Got it.

知道了。

Okay, thank you for all the details.

好的，謝謝您提供的所有詳細資訊。

I appreciate it.

我很感激。

And then maybe I'll just finish up with the Ionic system.

然後也許我會完成 Ionic 系統。

I believe you noted you're still on track for full commercial launch in Q4.

我相信您已經注意到您仍有望在第四季度全面商業發布。

Is there anything there -- any other detail there you can provide for us?

您可以為我們提供任何其他細節嗎？

And what is the backlog looking like in terms of interested parties, et cetera?

就有興趣的各方而言，積壓的工作是什麼樣的？

Thank you for taking the questions.

感謝您提出問題。

Yeah.

是的。

You're welcome.

不客氣。

So I mean, I think that -- if you recall, isotachophoresis, the Ionic system, were brought into the company through the acquisition of Purigen Biosystems.

所以我的意思是，我認為——如果你還記得的話，等速電泳、離子系統是透過收購 Purigen Biosystems 引入公司的。

And it really gives us a proprietary technology for isolation of ultrahigh molecular weight DNA with performance that exceeds any other options that are available today.

它確實為我們提供了一種用於分離超高分子量 DNA 的專有技術，其性能超越了當今可用的任何其他選項。

So we've been in the process of adapting that workflow to optical genome mapping and the field testing that's going on with pre-commercial units has been very positive.

因此，我們一直在調整該工作流程以適應光學基因組圖譜，並且預先商業單位正在進行的現場測試非常積極。

And the key contribution or sort of like value proposition that customers enjoy is that they can get this ultrahigh molecular weight DNA isolation done much more quickly, much less hands on time in a workflow that is really standardized, and standardization of the workflow is critical for labs that are using any technique at high volumes, right, because it's the same every single time so you get reduction in errors.

客戶享受的關鍵貢獻或類似的價值主張是，他們可以更快地完成這種超高分子量 DNA 分離，在真正標準化的工作流程中花費更少的時間，並且工作流程的標準化對於大量使用任何技術的實驗室，對吧，因為每次都是相同的，因此可以減少錯誤。

And so these are the benefits that I think everybody who is operating optical genome mapping at scale, which tends to be the customers who are adopting Stratys and many who have Saphyr but now are increasing their volume, they all are showing a keen interest in bringing it on Board.

因此，我認為這些是大規模操作光學基因組圖譜的每個人的好處，這往往是採用 Stratys 的客戶和許多擁有 Saphyr 但現在正在增加數量的客戶，他們都表現出了濃厚的興趣它在船上。

But having said that, until we have the product, we're conservative about really building a sales pipeline.

但話雖如此，在我們擁有產品之前，我們對於真正建立銷售管道持保守態度。

We want to make sure that we can meet customer expectations, not only in terms of product performance but in terms of timing.

我們希望確保能夠滿足客戶的期望，不僅在產品性能方面，而且在時間方面。

I got it.

我得到了它。

Okay.

好的。

Thank you so much, Erik.

非常感謝你，埃里克。

(Operator Instructions)

（操作員說明）

Eduardo Martinez-Montes, H.C. Wainwright.

愛德華多·馬丁內斯-蒙特斯，H.C.溫賴特。

Hi there.

你好呀。

Thanks so much for taking the question.

非常感謝您提出問題。

I had a question regarding the recent reimbursement with the CPT code that you guys announced, and when you should expect to see changes in revenue, and that would be forecasted in your guidance.

我有一個關於最近你們宣布的 CPT 代碼報銷的問題，以及你們預計何時會看到收入變化，這將在你們的指導中進行預測。

Yeah.

是的。

Thanks, Eduardo, and thanks for the question.

謝謝愛德華多，也謝謝你的提問。

It's interesting when we talk with folks on the buy side, they want to ask questions like what is the -- what's the question that your sales reps get most frequently?

有趣的是，當我們與買方的人交談時，他們想問這樣的問題：您的銷售代表最常遇到的問題是什麼？

And the question that they get most frequently in the United States is, is there a CPT code for this?

他們在美國最常遇到的問題是，有相應的 CPT 代碼嗎？

And so with the acceptance of the application for a code, we now have an affirmative answer to that question, which is great, and it really helps in the sales process.

因此，隨著代碼申請的接受，我們現在對這個問題有了肯定的答案，這很好，而且對銷售過程確實有幫助。

And it's anecdotal, but we've definitely seen the acceptance of the code and its publication already turned some accounts and start to accelerate their purchase process.

這是軼事，但我們確實看到代碼的接受度及其發布已經轉變了一些帳戶並開始加速他們的購買過程。

Now I want to be sort of careful about putting a lot of sort of near-term emphasis on a CPT code driving revenues.

現在，我想謹慎地將近期重點放在推動收入成長的 CPT 代碼上。

Our revenue plan currently assumes that we'll have a code, but there are other steps that are required.

我們的收入計劃目前假設我們將擁有一個代碼，但還需要其他步驟。

And those other steps include, first, pricing of the code.

這些其他步驟首先包括代碼定價。

So the code will become effective and appear on the clinical lab fee schedule in the beginning of 2025.

因此，該代碼將於 2025 年初生效並出現在臨床實驗室費用表中。

And the question is at what price?

問題是價格是多少？

And so CMS is in the process of doing that, and they've conducted a series of meetings in connection with our application, and this is just their normal schedule.

CMS 正在這樣做，他們已經就我們的應用程式召開了一系列會議，這只是他們的正常時間表。

And so we'll see that pricing sometime soon.

所以我們很快就會看到這個定價。

And I think what the code ends up getting priced at can have an impact.

我認為代碼最終的定價可能會產生影響。

There are a number of PLA codes, Proprietary Laboratory Analyte codes that are out there.

有許多 PLA 代碼，即專有實驗室分析物代碼。

And so I think that that's hopefully a good marker for where we would see the pricing of the CPT code.

因此，我認為這有望成為我們了解 CPT 代碼定價的一個很好的標記。

So it needs to get price and then show up on this clinical lab fee schedule early next year.

因此，它需要獲得價格，然後在明年初出現在臨床實驗室費用表中。

And then there needs to be coverage determinations made by payers.

然後付款人需要做出承保範圍決定。

And so Medicare is working on it, and that's something that we applied for at the end of 2023.

所以 Medicare 正在努力解決這個問題，這是我們在 2023 年底申請的。

So we expect those coverage determinations to be coming out probably early 2025.

因此，我們預計這些承保範圍決定可能會在 2025 年初公佈。

Other Medicare administrative contractors will be also evaluating OGM and making coverage determination.

其他醫療保險行政承包商也將評估 OGM 並確定承保範圍。

So I think it's really a smooth gradient of going from the CPT code to pricing to coverage.

所以我認為從 CPT 代碼到定價再到覆蓋範圍確實是一個平滑的梯度。

And as that process unfolds, more and more customers will gain confidence and bring optical genome mapping in, and a lot of them are bringing it in now and they're just getting ready to convert their existing pipelines and workflows over to OGM once this reimbursement is finalized.

隨著這一過程的展開，越來越多的客戶將獲得信心並引入光學基因組圖譜，其中許多人現在正在引入它，他們只是準備在報銷後將其現有的管道和工作流程轉換為 OGM已最終確定。

And so certainly, adoption is affected by it in the near term and then utilization in the longer term as coverage unfolds in 2025.

因此，可以肯定的是，短期內採用會受到影響，而隨著 2025 年覆蓋範圍的擴大，長期使用也會受到影響。

That's great.

那太棒了。

That's really insightful.

這真是有見地。

And congrats again on getting the code.

再次恭喜您獲得代碼。

I had another question regarding the recent deal with Revvity and kind of if you guys envision more deals like this and kind of the role that VIA and software as a service might play in your forecasting as well.

我還有一個關於最近與 Revvity 的交易的問題，以及你們是否設想更多這樣的交易，以及威盛和軟體即服務在你們的預測中可能扮演的角色。

So thank you.

所以謝謝你。

And I mean, I think that the Revvity deal, and I want to be clear about how it works, Revvity has a pretty comprehensive offering for Newborn Sequencing Research, and there are a variety of analyses that they conduct.

我的意思是，我認為 Revvity 交易，我想清楚它是如何運作的，Revvity 為新生兒測序研究提供了相當全面的產品，並且他們進行了各種分析。

And our software, the VIA software provides critical insights into the presence of certain variant types from NGS data from next-generation sequencing data.

我們的 VIA 軟體透過次世代定序資料的 NGS 資料提供了某些變異類型是否存在的重要見解。

And so that's highly complementary to what we're doing with optical genome mapping.

因此，這與我們在光學基因組圖譜方面所做的工作高度互補。

And it's not technically limited to just new screening.

從技術上講，它不僅限於新的篩選。

So we see that as being attractive for what Revvity is doing.

因此，我們認為這對 Revvity 所做的事情很有吸引力。

That's not a market that we would go after, but it's significant and can drive significant utilization of our software and revenue accordingly.

這不是我們想要追求的市場，但它很重要，可以相應地提高我們軟體的使用率和收入。

But you can imagine that there are other examples of NGS analysis where the software can provide a lot of value.

但您可以想像，還有其他 NGS 分析範例，該軟體可以提供很多價值。

And so I would say that the answer to your question is that, yes, we see the potential for other deals and end-user sales of the software for applications outside of OGM are meaningful revenue contributors to the top line today and margin, I mean, the software is a very high-margin product.

所以我想說，你的問題的答案是，是的，我們看到OGM 之外的應用程式的其他交易和最終用戶銷售軟體的潛力，對今天的收入和利潤有重要的收入貢獻者，我的意思是，該軟體是一個利潤非常高的產品。

So as a life sciences solutions provider, the software that we provide is a revenue driver, a value driver and a source of significant growth potential going forward.

因此，作為生命科學解決方案提供者，我們提供的軟體是收入驅動因素、價值驅動因素以及未來巨大成長潛力的來源。

Got it.

知道了。

Thanks so much.

非常感謝。

Thank you.

謝謝。

And that does conclude our question and answer session for today's conference.

今天會議的問答環節到此結束。

I'd now like to turn the conference back over to Erik Holmlin for any closing remarks.

現在我想將會議轉回給埃里克·霍姆林（Erik Holmlin）做總結發言。

Thank you, Crystal, and thank you to everyone who has joined the call today, and we look forward to updating you on our next report.

謝謝克里斯托，也感謝今天加入電話會議的所有人，我們期待為您提供下一份報告的最新情況。

Good afternoon.

午安.

Thank you.

謝謝。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect everyone.

您現在可以斷開所有人的連線。

Have a wonderful day.

祝你有美好的一天。