T2 Biosystems Inc (TTOO) 2023 Q1 法說會逐字稿

Greetings. Welcome to the T2 Biosystems, Inc. First Quarter 2023 Earnings Conference Call. (Operator Instructions) Please note, this conference is being recorded.

問候。歡迎參加 T2 Biosystems, Inc. 2023 年第一季度收益電話會議。 （操作員說明）請注意，正在錄製此會議。

I will now turn the conference over to your host, Trip Taylor. You may begin.

我現在將會議轉交給主持人 Trip Taylor。你可以開始了。

Thank you, operator. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Those include statements related to T2 Biosystems' future financial and operating results and plans for developing and marketing new products. Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in T2 Biosystems' annual report on Form 10-K filed with the SEC on March 31, 2023, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.

謝謝你，運營商。我想提醒大家的是，今天管理層的評論和問題的回答將包含前瞻性陳述。其中包括與 T2 Biosystems 未來財務和經營業績以及新產品開發和營銷計劃相關的報表。前瞻性陳述基於截至今天的估計和假設，並受到可能導致實際結果與這些陳述明示或暗示的結果大不相同的風險和不確定性的影響，包括 T2 Biosystems 年度報告中描述的風險和不確定性2023 年 3 月 31 日向美國證券交易委員會提交的 10-K 表格，以及公司不時向美國證券交易委員會提交的其他文件。除非法律要求，否則公司不承擔公開更新或修改任何前瞻性陳述的義務。

With that, I would like to turn the call over to Chairman and CEO, John Sperzel. John?

有了這個，我想把電話轉給董事長兼首席執行官 John Sperzel。約翰？

Thank you for joining our first quarter 2023 earnings and business update call.

感謝您加入我們的 2023 年第一季度收益和業務更新電話會議。

Today, I will start by addressing two press releases that we issued earlier this morning, then discuss our performance during the first quarter, including the progress we have made across our three corporate priorities as outlined in our first quarter earnings press release. I will then turn the call over to John Sprague, our Chief Financial Officer, who will review our first quarter financial results and our outlook for 2023, before I provide closing remarks and we open the call for questions and answers.

今天，我將首先介紹我們今天上午早些時候發布的兩份新聞稿，然後討論我們在第一季度的業績，包括我們在第一季度收益新聞稿中概述的三個公司優先事項方面取得的進展。然後，我會將電話轉給我們的首席財務官約翰·斯普拉格 (John Sprague)，他將審查我們第一季度的財務業績和 2023 年的展望，然後我將發表結束語，然後我們開始提問和回答。

This morning, we issued a press release announcing an FDA 510(k) submission for the T2Biothreat panel, a product that we developed in collaboration with the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, or BARDA.

今天早上，我們發布了一份新聞稿，宣布向 FDA 510(k) 提交 T2Biothreat panel，該產品是我們與美國衛生與公共服務部、戰略準備和響應管理局、生物醫學高級研究與開發部合作開發的權威，或 BARDA。

The FDA submission marks an important milestone in our commitment to protect Americans from the threat of deliberate or naturally occurring outbreaks of Biothreat pathogens, and follows the recently completed U.S. clinical evaluation that demonstrated very high sensitivity and specificity, including 350 contrive positive samples and over 470 negative blood samples from both healthy and federal subjects.

FDA 的提交標誌著我們致力於保護美國人免受蓄意或自然發生的生物威脅病原體爆發的威脅的一個重要里程碑，並且遵循最近完成的美國臨床評估，該評估顯示出非常高的敏感性和特異性，包括 350 個陽性樣本和 470 多個來自健康和聯邦受試者的陰性血樣。

The T2Biothreat panel is a fully automated direct-from-blood test designed to run on the FDA-cleared T2Dx instrument and simultaneously detects six biothreat pathogens, identified as threats by the U.S. Centers for Disease Control and Prevention, or CDC, including the organisms that cause Anthrax, Tularemia, Glanders Plague and Typhus. If not treated promptly, infections with these biothreat pathogens can result in mortality rates of 40% to 90%.

T2Biothreat panel 是一種完全自動化的直接血液檢測，旨在在 FDA 批准的 T2Dx 儀器上運行，同時檢測六種生物威脅病原體，這些病原體被美國疾病控制和預防中心 (CDC) 確定為威脅，包括引起炭疽、兔熱病、鼻疽和斑疹傷寒。如果不及時治療，這些生物威脅病原體的感染可導致 40% 至 90% 的死亡率。

The T2Biothreat panel is able to detect these biothreat pathogens within 4 hours directly from blood and provide clinicians with the needed information to appropriately treat infected patients. We believe the T2Biothreat panel demonstrates very high sensitivity and specificity for a direct-from-blood multi-target biothreat product and is the only such product developed by a U.S.-owned company, which we think will have an important factor in the discussions with the U.S. government regarding procurement of the T2Biothreat panel.

T2Biothreat 面板能夠在 4 小時內直接從血液中檢測出這些生物威脅病原體，並為臨床醫生提供適當治療感染患者所需的信息。我們相信 T2Biothreat 面闆對直接來自血液的多目標生物威脅產品表現出非常高的靈敏度和特異性，並且是唯一由美國公司開發的此類產品，我們認為這將在與美國政府關於採購 T2Biothreat 面板。

This morning, we also issued a press release announcing the exploration of a range of strategic alternatives focused on maximizing value, and the implementation of a restructuring program. After careful consideration, the company has engaged an advisory firm to explore all potential strategic alternatives to maximize value, including an acquisition, merger, reverse merger, other business combination, sale of assets, licensing and other strategic transactions. No updates on the process are expected to be provided during the evaluation period and less than [until] the Board of Directors has concluded that disclosure is appropriate or required.

今天上午，我們還發布了一份新聞稿，宣布探索一系列以價值最大化為重點的戰略選擇，並實施重組計劃。經過仔細考慮，公司已聘請一家諮詢公司探索所有潛在的戰略選擇，以實現價值最大化，包括收購、合併、反向合併、其他業務合併、出售資產、許可和其他戰略交易。預計在評估期間不會提供有關流程的更新，並且少於 [直到] 董事會得出結論認為披露是適當的或需要的。

A strategic restructuring program is being implemented to preserve capital and better position the company to explore all strategic alternatives, while continuing to support its customers, pursue new commercial opportunities and advance pipeline development. The restructuring program is designed to reduce annual operating costs and includes, among other things, an incremental reduction of the company's workforce by nearly 30%, which was completed last week. I will discuss further strategic changes in the context of our three corporate priorities.

正在實施一項戰略重組計劃，以保護資本並更好地定位公司以探索所有戰略選擇，同時繼續支持其客戶，尋求新的商業機會並推進管道開發。重組計劃旨在降低年度運營成本，其中包括將公司員工人數逐步減少近 30%，該計劃於上週完成。我將在我們的三個公司優先事項的背景下討論進一步的戰略變化。

Turning to our recent business progress. The T2 Biosystems team has recently achieved a number of key milestones that position the company for success and support our mission to fundamentally change the way medicine is practiced through transformative culture independent diagnostics that improves the lives of patients around the world.

談到我們最近的業務進展。 T2 Biosystems 團隊最近取得了一系列關鍵里程碑，這些里程碑使公司取得了成功，並支持我們的使命，即通過變革性文化獨立診斷從根本上改變醫學實踐的方式，從而改善世界各地患者的生活。

These accomplishments support our three corporate priorities: accelerating our sales, enhancing our operations and advancing our pipeline.

這些成就支持我們的三個企業優先事項：加速我們的銷售、加強我們的運營和推進我們的管道。

Starting with our first priority, accelerating our sales. Our commercial strategy is focused on increasing the adoption of our products, with emphasis on increasing sales of our FDA-cleared sepsis test panels and expanding the installed base of our FDA-cleared T2Dx instruments.

從我們的首要任務開始，加速我們的銷售。我們的商業戰略側重於提高我們產品的採用率，重點是增加我們經 FDA 批准的敗血症測試面板的銷量，並擴大我們經 FDA 批准的 T2Dx 儀器的安裝基礎。

As we stated during our March 2023 earnings call, our top commercial priority will be increasing the use of our sepsis test panels with existing hospital customers. To drive increasing sepsis test revenue, we made two important changes to our sales strategy. The first change consists of expanding our sales targets to include larger hospitals and those that have a higher likelihood of achieving our annualized sepsis test panel utilization target of $200,000.

正如我們在 2023 年 3 月的財報電話會議上所說，我們的首要商業優先事項將是增加現有醫院客戶對敗血症測試板的使用。為了推動增加敗血症測試收入，我們對銷售策略進行了兩項重要更改。第一個變化包括擴大我們的銷售目標，以包括更大的醫院和更有可能實現我們 200,000 美元的年度膿毒症測試板利用率目標的醫院。

Larger hospitals have shown greater potential for increased use of our T2Bacteria and T2Candida panels, given their increased patient volume and the number of patients that require complex treatments. At the same time, we acknowledge that larger hospitals have larger sales cycles, but believe balancing our sales funnel with a number of large hospital targets to complement our current targets of smaller and critical access hospitals provides greater opportunity for long-term sustained growth.

考慮到患者數量的增加和需要復雜治療的患者數量的增加，大型醫院已顯示出增加使用我們的 T2Bacteria 和 T2Candida 面板的更大潛力。與此同時，我們承認大型醫院的銷售週期更長，但相信平衡我們的銷售漏斗與一些大型醫院目標以補充我們目前的小型和關鍵醫院目標為長期持續增長提供了更大的機會。

The second change consists of shifting our sales incentive compensation plan to weigh more heavily on sepsis test revenue as compared to instruments. Ultimately, this is intended to align with our strategy of more time spent with legacy accounts as well as to accelerate the time from when an instrument contract is signed to when the hospital goes live with patient testing. Our commercial, medical affairs and support teams are closely integrated to ensure we can provide customers with the training and education required to ramp their utilization and realize the clinical and economic benefits offered by our sepsis products.

第二個變化包括改變我們的銷售激勵補償計劃，與儀器相比，更重視膿毒症測試收入。最終，這旨在與我們將更多時間花在遺留賬戶上的戰略保持一致，並加快從簽署儀器合同到醫院開始進行患者檢測的時間。我們的商業、醫療事務和支持團隊緊密結合，以確保我們能夠為客戶提供所需的培訓和教育，以提高他們的利用率並實現我們的敗血症產品提供的臨床和經濟效益。

During the first quarter, we achieved sepsis and related product revenue of $1.7 million compared to $2 million in the prior year period, driven by lower instrument revenue. We also ended the first quarter with a sepsis test panel backorder of $230,000. We generated sepsis test panel revenue of $1.2 million, representing an 11% increase compared to the prior year period, despite ending the quarter with a $230,000 back order. Had we been able to clear the back order as of March 31, the sepsis test panel increase would have been 34% compared to the prior year period.

在第一季度，由於儀器收入下降，我們實現了敗血症和相關產品收入 170 萬美元，而去年同期為 200 萬美元。我們還以 230,000 美元的敗血症測試面板延期交貨結束了第一季度。我們產生了 120 萬美元的敗血症測試面板收入，與去年同期相比增長了 11%，儘管本季度末有 230,000 美元的延期交貨訂單。如果我們能夠在 3 月 31 日之前清除延期交貨訂單，那麼膿毒症測試面板與去年同期相比將增加 34%。

Importantly, we increased sales of T2Bacteria panel by 55% globally, including a 109% increase in the U.S. market compared to the prior year period. We entered into contracts for five T2Dx instruments during the first quarter, all of which were sold outside of the United States market. We believe these results are representative of the change in our commercial strategy to focus more on increasing sepsis test panel utilization in legacy accounts and of larger hospitals with longer sales cycles.

重要的是，我們在全球範圍內將 T2Bacteria 面板的銷售額增加了 55%，其中美國市場與去年同期相比增加了 109%。我們在第一季度簽訂了五種 T2Dx 儀器的合同，所有這些儀器都在美國市場以外銷售。我們認為這些結果代表了我們商業戰略的變化，即更多地關注增加遺留賬戶和銷售週期較長的大型醫院的敗血症測試面板利用率。

A strong validation of our new commercial strategy is that our U.S. T2Bacteria Panel revenues more than doubled in the first quarter of 2023 compared to the prior year period. This was supported by the adoption of four new hospital accounts ordering the T2Bacteria Panel for the first time, bringing our fourth quarter 2022 instrument closes online in a faster timeline.

對我們新商業戰略的有力驗證是，與去年同期相比，我們在美國的 T2Bacteria Panel 收入在 2023 年第一季度增長了一倍以上。這得益於首次訂購 T2Bacteria Panel 的四個新醫院賬戶的採用，使我們的 2022 年第四季度儀器在更快的時間內在線關閉。

We're pleased with the adoption rates of the T2Bacteria Panel as more hospitals are realizing the value of the product, as evidenced by the increased demand in our legacy accounts. We also have approximately 40 T2Dx instruments in U.S. hospital laboratories that were initially sold for COVID-19 testing and which we are targeting for conversion to our sepsis test panels. I'm pleased to inform you that another instrument was converted to our sepsis test panels during the first quarter of 2023, and we expect additional conversions from COVID-19 to sepsis in the coming months.

隨著越來越多的醫院意識到該產品的價值，我們對 T2Bacteria Panel 的採用率感到滿意，我們的舊賬戶需求增加就是明證。我們在美國醫院實驗室也有大約 40 台 T2Dx 儀器，最初出售用於 COVID-19 測試，我們的目標是將其轉換為我們的敗血症測試面板。我很高興地通知您，在 2023 年第一季度，另一台儀器被轉換為我們的敗血症測試面板，我們預計在未來幾個月內會有更多的從 COVID-19 轉換為敗血症。

Separately, we're excited that we recently entered into multiyear pricing agreements with two large U.S. health systems, covering a total of 69 U.S. hospitals. The key hospitals in each of these two health systems are multiyear users of T2 Biosystems sepsis test panels. In those hospitals, our sepsis panels are integrated into the sepsis management protocols, and they're experiencing improved clinical benefits and positive economic benefits.

另外，我們很高興最近與美國兩個大型衛生系統簽訂了多年期定價協議，覆蓋了美國 69 家醫院。這兩個衛生系統中每一個的主要醫院都是 T2 Biosystems 膿毒症測試板的多年用戶。在這些醫院中，我們的敗血症面板被整合到敗血症管理方案中，他們正在體驗改善的臨床效益和積極的經濟效益。

The new agreements provide these 69 U.S. hospitals with contracted pricing for the T2Bacteria Panel and the T2Candida Panel for an initial 3-year period as well as options to procure T2Dx instruments. We're certainly excited about the opportunity to expand the use of our sepsis products within these two large health systems, increasing sepsis test utilization within existing hospitals and expanding broadly across health systems are core tenets of our growth strategy and represent top U.S. commercial priorities.

新協議為這 69 家美國醫院提供了最初 3 年期間 T2Bacteria Panel 和 T2Candida Panel 的合同定價，以及採購 T2Dx 儀器的選擇權。我們當然很高興有機會在這兩個大型衛生系統中擴大我們的敗血症產品的使用，增加現有醫院的敗血症測試利用率並在整個衛生系統中廣泛擴展是我們增長戰略的核心原則，代表了美國的首要商業優先事項。

Internationally, there continues to be a significant commercial opportunity for our T2Dx instruments and sepsis test panels. This is reflected by continued sales of instruments and sepsis test panels to our international distributor partners. We continue to see strong demand in Europe and the Middle East and expect to continue to expand distribution across the Asia Pacific region in the coming months.

在國際上，我們的 T2Dx 儀器和膿毒症測試板繼續存在重要的商業機會。這反映在繼續向我們的國際分銷商合作夥伴銷售儀器和膿毒症測試板。我們繼續看到歐洲和中東的強勁需求，並預計在未來幾個月內繼續擴大在亞太地區的分銷。

Our efforts to increase awareness of the benefits of our sepsis test panels extend beyond the activities of our commercial team, medical affairs team, key opinion leaders, and Scientific Advisory Board. In April, we presented clinical data at the European Society of Clinical Microbiology and Infectious Disease, or ESCMID. Three presentations were delivered by clinicians highlighting their real-world experience, including the speed, accuracy and clinical benefit delivered by our T2Dx instrument and sepsis test panels.

我們為提高對膿毒症檢測試劑盒的益處的認識所做的努力超出了我們的商業團隊、醫療事務團隊、主要意見領袖和科學顧問委員會的活動範圍。 4 月，我們在歐洲臨床微生物學和傳染病學會 (ESCMID) 上展示了臨床數據。臨床醫生進行了三場演講，重點介紹了他們的真實經驗，包括我們的 T2Dx 儀器和膿毒症測試面板提供的速度、準確性和臨床益處。

Driving awareness of the benefits of the T2 technology, combined with our optimized commercial game plan, gives us confidence in our ability to accelerate sales in the coming quarters.

提高人們對 T2 技術優勢的認識，再加上我們優化的商業遊戲計劃，使我們對在未來幾個季度加速銷售的能力充滿信心。

Moving to our second priority, enhancing our operations. We recognize that efficient operations are critical to our long-term success. To drive greater efficiency, we have taken measures to reduce expenses across the company. T2 Biosystems is now operating as a leaner organization with 110 employees compared to 204 employees in May of 2022. We expect the net result of our workforce reduction and cost control measures to significantly reduce our quarterly cash burn throughout 2023.

轉向我們的第二個優先事項，加強我們的運營。我們認識到高效運營對我們的長期成功至關重要。為了提高效率，我們已採取措施減少整個公司的開支。 T2 Biosystems 現在是一個精簡組織，擁有 110 名員工，而 2022 年 5 月只有 204 名員工。我們預計裁員和成本控制措施的最終結果將在 2023 年顯著減少我們的季度現金消耗。

Driving increased leverage is a constant focus for our organization. We can achieve significant gross margin expansion as our customers continue to increase sepsis test panel utilization. Test panels carry a higher contribution margin. And as we increase test unit volumes, our overhead will be allocated across greater volume, which can lead to improved product gross margins. To support the growing demand for our sepsis test panels our operations and manufacturing teams are hard at work, managing the supply chain and continually improving our manufacturing process to drive greater efficiency.

提高槓桿率是我們組織一直關注的焦點。隨著我們的客戶繼續提高敗血症測試板的利用率，我們可以實現顯著的毛利率增長。測試面板具有更高的邊際收益。隨著我們增加測試單位數量，我們的管理費用將分配給更大的數量，這可以提高產品毛利率。為了支持對我們的敗血症測試板不斷增長的需求，我們的運營和製造團隊正在努力工作，管理供應鏈並不斷改進我們的製造流程以提高效率。

Over the last several months, we've strengthened our operations team by hiring a new Vice President of Operations and subsequently hired new manufacturing and supply chain leadership. On our March 2023 call, we discussed a raw material issue that we identified during our routine internal quality inspection that was limiting our ability to manufacture sufficient volume of sepsis test panels to meet customer demand. Considering we identified this issue during our in-process inspection, product that we shipped to customers or distributors was not affected. We're pleased to report that we have cleared the $230,000 back order for the T2Candida Panel and T2Bacteria Panel referenced earlier, since the end of the first quarter, and we're returning to more normalized shipment patterns for these products. We're still working through the materials issue for the T2Resistance Panel and we expect to have it resolved before the end of the second quarter.

在過去的幾個月裡，我們聘請了一位新的運營副總裁，並隨後聘請了新的製造和供應鏈領導層，從而加強了我們的運營團隊。在 2023 年 3 月的電話會議上，我們討論了在例行內部質量檢查中發現的一個原材料問題，該問題限制了我們生產足夠數量的敗血症測試板以滿足客戶需求的能力。考慮到我們在過程檢查中發現了這個問題，我們運送給客戶或分銷商的產品沒有受到影響。我們很高興地報告，自第一季度末以來，我們已經清除了之前提到的 T2Candida Panel 和 T2Bacteria Panel 的 230,000 美元延期交貨訂單，並且我們將恢復這些產品的更規範化的發貨模式。我們仍在努力解決 T2Resistance Panel 的材料問題，我們希望在第二季度末之前解決它。

Finally, in the first quarter, we strengthened our balance sheet by raising $12 million in gross proceeds. In the coming quarters and consistent with the workforce reduction that we implemented last week, we will continue to be disciplined with our operating expenses to increase our operating leverage and extend our cash runway.

最後，在第一季度，我們通過籌集 1200 萬美元的總收益來加強我們的資產負債表。在接下來的幾個季度中，根據我們上週實施的裁員計劃，我們將繼續控制我們的運營支出，以增加我們的運營槓桿並擴大我們的現金跑道。

Moving to our third priority, advancing our pipeline. T2 Biosystems' novel technology platform and scientific expertise position the company to expand our addressable markets in the future. Our new product pipeline is focused on two goals: one, developing new tests to expand the test menu on the T2Dx Instrument; and two, developing a next-generation instrument and comprehensive sepsis panel.

轉到我們的第三個優先事項，推進我們的管道。 T2 Biosystems 的新技術平台和科學專業知識使公司能夠在未來拓展我們的目標市場。我們的新產品管線專注於兩個目標：一是開發新測試以擴展 T2Dx 儀器上的測試菜單；第二，開發下一代儀器和綜合敗血症面板。

We're currently developing five new products to expand the test menu on our FDA-cleared T2Dx Instrument, including the T2Biothreat Panel, the T2Resistance Panel, the T2Lyme Panel, Candida auris and Acinetobacter baumannii. Each new test panel or test represents a differentiated solution to rapidly identify harmful pathogens and potentially allow clinicians to achieve faster targeted therapy. We believe expanding the testing menu will increase both instrument adoption and test utilization.

我們目前正在開發五種新產品，以擴展我們經 FDA 批准的 T2Dx 儀器的測試菜單，包括 T2Biothreat Panel、T2Resistance Panel、T2Lyme Panel、Candida auris 和 Acinetobacter baumannii。每個新的測試面板或測試都代表了一種差異化的解決方案，可以快速識別有害病原體，並有可能讓臨床醫生實現更快的靶向治療。我們相信擴大測試菜單將增加儀器採用和測試利用率。

As we discuss the T2Biothreat panel earlier in the call, I'll focus my comments on the four remaining menu expansion programs. First, T2Resistance Panel is a direct from blood molecular diagnostic test designed to simultaneously detect 13 antibiotic resistance genes known to cause antibiotic-resistant infections in just 3 to 5 hours, without the need to wait days for a positive blood culture. The T2Resistance Panel, which is marketed and sold in Europe under CE Mark, detects resistance genes that may confer resistance to common antimicrobials, such as carbapenems, methicillin and vancomycin. We have advanced the U.S. clinical trial and completed nearly 90% of patient enrollment and plan to file our submission to the FDA upon completion of the study.

當我們在電話會議的早些時候討論 T2Biothreat 面板時，我將把我的評論集中在剩下的四個菜單擴展程序上。首先，T2Resistance Panel 是一種直接來自血液的分子診斷測試，旨在在短短 3 至 5 小時內同時檢測 13 種已知會導致抗生素耐藥性感染的抗生素耐藥基因，而無需等待數天才能獲得陽性血培養。 T2Resistance Panel 以 CE 標誌在歐洲上市銷售，可檢測可能賦予常見抗菌藥物耐藥性的耐藥基因，例如碳青黴烯類、甲氧西林和萬古黴素。我們已經推進了美國臨床試驗並完成了近 90% 的患者登記，併計劃在研究完成後向 FDA 提交我們的申請。

As a reminder, the T2Resistance Panel was granted breakthrough device designation by the FDA, which provides for a prioritized review upon submission and has received funding under our contract with BARDA.

提醒一下，T2Resistance Panel 已獲得 FDA 授予的突破性設備指定，該指定在提交後進行優先審查，並已根據我們與 BARDA 的合同獲得資金。

Second, the T2Lyme Panel is a direct-from-blood molecular diagnostic test to detect Borrelia burgdorferi, the bacteria that is the major cause of Lyme disease in the United States. The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease, and we believe it will provide a significant advantage over the currently recommended serological testing that requires the presence of antibodies, which can take the body 4 to 6 weeks to create post-infection.

其次，T2Lyme Panel 是一種直接來自血液的分子診斷測試，用於檢測 Borrelia burgdorferi，這種細菌是美國萊姆病的主要原因。 T2Lyme Panel 旨在測試具有萊姆病體徵和症狀的個體，並幫助診斷早期萊姆病，我們相信，與目前推薦的需要抗體存在的血清學檢測相比，它具有顯著優勢，後者可以採取身體在感染後4～6週內形成。

In 2022, our T2Lyme Panel was named a winner in the Lyme Innovation Accelerator, or LymeX, a partnership between the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation, the largest public-private partnership for Lyme disease that plans to award up to a total of $9 million to future award winners.

2022 年，我們的 T2Lyme 小組被評為萊姆病創新加速器或 LymeX 的獲勝者，這是美國衛生與公共服務部與 Steven & Alexandra Cohen 基金會之間的合作夥伴關係，這是萊姆病最大的公私合作夥伴關係，計劃向未來的獲獎者頒發總額高達 900 萬美元的獎金。

We previously also received a patent from the U.S. Patent and Trademark Office, covering the T2Lyme Panel. And FDA granted breakthrough device designation for the T2Lyme Panel in 2022, allowing for a prioritized review process upon submission to the FDA. We have completed the early assay development for the T2Lyme Panel and established a preliminary level of detection, or LOD, of 2 CFU per ml. We plan to initiate commercialization of the T2Lyme panel as a laboratory developed test and subsequently commence a U.S. clinical trial to support submission for FDA clearance.

我們之前還從美國專利商標局獲得了一項專利，涉及 T2Lyme 面板。 FDA 於 2022 年授予 T2Lyme Panel 突破性設備稱號，允許在提交給 FDA 後進行優先審查。我們已經完成了 T2Lyme Panel 的早期檢測開發，並建立了每毫升 2 CFU 的初步檢測水平或 LOD。我們計劃將 T2Lyme 面板作為實驗室開發的測試進行商業化，隨後開始美國臨床試驗以支持提交 FDA 批准。

Third, we plan to add Candida auris to our T2Candida Panel, a direct-from-blood molecular diagnostic test that detects over 90% of Candida bloodstream infections. Candida auris is a multidrug-resistant pathogen recognized by the CDC as a serious global health threat, with a mortality rate up to 60%. According to CDC, Candida auris is difficult to identify with standard laboratory methods, which can lead to inappropriate treatment. And some strains are resistant to all three available classes of antifungals.

第三，我們計劃將 Candida auris 添加到我們的 T2Candida Panel 中，這是一種直接來自血液的分子診斷測試，可檢測 90% 以上的念珠菌血流感染。耳念珠菌是一種多重耐藥病原體，被 CDC 認定為嚴重的全球健康威脅，死亡率高達 60%。據 CDC 稱，用標準實驗室方法很難識別耳念珠菌，這可能導致不適當的治療。有些菌株對所有三種可用的抗真菌藥都有耐藥性。

The CDC estimates the costs associated with U.S. fungal diseases in general are as high as $48 billion annually and is called on public health professionals to lower the burden of fungal disease by continuing to raise awareness of the life-saving benefits of early detection and proper treatment. We believe adding Candida auris to our existing T2Candida Panel will provide a significant time advantage compared to other blood culture-based methods and strengthen the value proposition of the test panel, making it even more attractive to our hospital customers.

CDC 估計與美國真菌病相關的費用每年高達 480 億美元，並呼籲公共衛生專業人員通過繼續提高人們對早期發現和適當治療的挽救生命益處的認識來減輕真菌病的負擔.我們相信，與其他基於血培養的方法相比，將 Candida auris 添加到我們現有的 T2Candida 面板中將提供顯著的時間優勢，並加強測試面板的價值主張，使其對我們的醫院客戶更具吸引力。

We've recently completed feasibility and early development of a diagnostic test to detect the Candida auris pathogen, and I'm pleased to report that we also recently applied for FDA breakthrough device designation for this test.

我們最近完成了檢測耳念珠菌病原體的診斷測試的可行性和早期開發，我很高興地報告，我們最近還為該測試申請了 FDA 突破性設備指定。

Finally, we plan to add Acinetobacter baumannii to the T2Bacteria Panel, a direct-from-blood molecular diagnostic test to expand the number of pathogens detected on the test panel. Acinetobacter baumanni can cause bloodstream infections, especially in critically ill patients, which can range from benign transient bacteremia to septic shock, and as reported, to have a crude ICU mortality rate of 34% to 43%.

最後，我們計劃將鮑曼不動桿菌添加到 T2Bacteria Panel 中，這是一種直接從血液中提取的分子診斷測試，旨在擴大測試面板上檢測到的病原體數量。鮑曼不動桿菌可引起血流感染，尤其是危重患者，其範圍從良性短暫性菌血症到感染性休克，據報導，ICU 粗死亡率為 34% 至 43%。

Acinetobacter infections rarely occur outside of healthcare settings in the United States and can disproportionately impact those with weakened immune systems, chronic lung disease or diabetes. Acinetobacter can be resistant to many antibiotics, including carbapenems, highlighting the importance of rapid detection and targeted antimicrobial treatment.

在美國，不動桿菌感染很少發生在醫療機構之外，並且會對免疫系統較弱、慢性肺病或糖尿病的人造成不成比例的影響。不動桿菌可以對包括碳青黴烯類在內的許多抗生素產生耐藥性，這凸顯了快速檢測和靶向抗菌治療的重要性。

Looking ahead at longer-term projects, we're focused on developing next-generation sepsis products, including a new instrument and a comprehensive sepsis test panel. The next-generation instrument is designed to increase the number of detections from a single whole blood sample. The comprehensive sepsis test panel is a direct-from-blood test designed to detect greater than 95% of all bloodstream infections caused by bacterial and Candida species, and antibiotic resistance genes identified as threats by the CDC in a single test with a time to result of approximately 3 hours. The next-generation instrument and comprehensive sepsis test panel have been funded under our contract with BARDA.

展望長期項目，我們專注於開發下一代敗血症產品，包括新儀器和綜合敗血症測試板。下一代儀器旨在增加單個全血樣本的檢測次數。綜合性敗血症檢測組是一項直接從血液中提取的檢測，旨在檢測超過 95% 的由細菌和念珠菌引起的所有血流感染，以及在一次檢測中被 CDC 確定為威脅的抗生素耐藥基因，並在一段時間內得出結果大約 3 小時。根據我們與 BARDA 的合同，我們已經為下一代儀器和綜合敗血症測試板提供了資金。

We have been operating in Option 3 of the BARDA contract, after successfully meeting all development milestones under the base phase, Option 1, Option 2A and Option 2B. We have filed a no-cost extension with BARDA under Option 3 to allow additional time to complete the U.S. clinical trial for the T2Resistance Panel. Further funding from BARDA may resume following the completion of Option 3 and BARDA's potential exercise of Option 4 of the contract. Considering timing is still and funding are uncertain, we're not providing guidance on BARDA revenue at this time.

在成功滿足基礎階段、選項 1、選項 2A 和選項 2B 下的所有開發里程碑後，我們一直在 BARDA 合同的選項 3 中運營。我們已根據選項 3 向 BARDA 提交了免費延期申請，以便有更多時間完成 T2Resistance Panel 的美國臨床試驗。在選項 3 完成以及 BARDA 可能行使合同的選項 4 後，BARDA 可能會繼續提供進一步的資金。考慮到時間仍然和資金不確定，我們目前不提供 BARDA 收入的指導。

With that, I'll now turn the call over to John Sprague to provide a detailed update on our first quarter financial results and our financial outlook for 2023. John?

有了這個，我現在將電話轉給 John Sprague，提供有關我們第一季度財務業績和 2023 年財務前景的詳細更新。約翰？

Thank you, John. Total revenue for the first quarter of 2023 was $2.1 million, a 71% decrease compared to the prior year period, driven by a decline in COVID-19 test sales and reduced BARDA revenues. Product revenue was $1.7 million, a decrease of 57% compared to the prior year period, driven by a 98% decline in COVID-19 test sales, partially offset by increased sepsis test sales.

謝謝你，約翰。 2023 年第一季度的總收入為 210 萬美元，與去年同期相比下降 71%，這是受 COVID-19 測試銷售下降和 BARDA 收入減少的推動。產品收入為 170 萬美元，與去年同期相比下降了 57%，這是由於 COVID-19 測試銷售額下降了 98%，部分被敗血症測試銷售額增加所抵消。

Research and contribution revenues were $400,000, an 88% decrease compared to the prior year period, driven by decreased BARDA contract activities. Cost of product revenue for the first quarter of 2023 was $4 million, a 35% decrease compared to the prior year period, driven by decreased COVID-19 test sales. Research and development expenses were $4.5 million, a 33% decrease compared to the prior year period, driven by decreased BARDA contract activities.

受 BARDA 合同活動減少的推動，研究和貢獻收入為 400,000 美元，比上年同期下降 88%。 2023 年第一季度的產品收入成本為 400 萬美元，與去年同期相比下降 35%，這是受 COVID-19 測試銷售下降的推動。由於 BARDA 合同活動減少，研發費用為 450 萬美元，比上年同期減少 33%。

Selling, general and administrative expenses were $7.3 million, a 21% decrease compared to the prior year period, driven by decreased medical affairs spending. Net loss for the first quarter of 2023 was $18 million, $1.32 per share, compared to a net loss of $16.5 million, $4.86 per share in the prior year period. Cash and cash equivalents were $10.1 million at March 31, 2023.

銷售、一般和行政費用為 730 萬美元，較上年同期下降 21%，這是受醫療事務支出減少的推動。 2023 年第一季度淨虧損 1800 萬美元，每股虧損 1.32 美元，上年同期淨虧損 1650 萬美元，每股虧損 4.86 美元。截至 2023 年 3 月 31 日，現金和現金等價物為 1010 萬美元。

In the first quarter of 2023, we raised $1 million from ATM sales and $11 million from a public offering. The 30% workforce reduction will decrease our burn. We remain in compliance with our loan covenants. We reiterate guidance and expect 2023 total sepsis and related product revenue of $11 million to $13 million.

2023 年第一季度，我們通過 ATM 銷售籌集了 100 萬美元，通過公開募股籌集了 1100 萬美元。裁員 30% 將減少我們的消耗。我們仍然遵守我們的貸款契約。我們重申指導意見，預計 2023 年敗血症及相關產品總收入為 1100 萬至 1300 萬美元。

Thank you, and back to John Sperzel for closing remarks.

謝謝，然後回到 John Sperzel 的結束語。

Thank you, John. Before I conclude, I'd like to address our NASDAQ listing compliance. On November 22, 2022, we received a letter from NASDAQ indicating that for the last 30 consecutive business days, the market value of listed securities had been below the $35 million minimum requirement for continued listing on the NASDAQ capital market under NASDAQ Listing Rule 5550(b2).

謝謝你，約翰。在結束之前，我想談談我們在納斯達克上市的合規性。 2022 年 11 月 22 日，我們收到納斯達克的一封信函，表明在過去連續 30 個工作日，上市證券的市值一直低於納斯達克上市規則 5550（納斯達克上市規則 5550）在納斯達克資本市場繼續上市的最低要求 3500 萬美元（ b2).

We provided an initial period of 180 calendar days or until May 22, 2023, to regain compliance. We expect to receive a letter from NASDAQ, informing us that our shares have failed to comply with the MVLS required for continued listing on the NASDAQ Capital Market, and as a result, our shares are subject to delist. We will file an appeal and hearing (inaudible) with NASDAQ, which NASDAQ must grant, which will stay the delisting of our common stock from the NASDAQ Capital Market, pending a NASDAQ Listing Qualifications hearing panel's decision.

我們提供了 180 個日曆日的初始期限或到 2023 年 5 月 22 日，以恢復合規性。我們預計會收到納斯達克的一封信，通知我們我們的股票未能遵守繼續在納斯達克資本市場上市所需的 MVLS，因此我們的股票將被退市。我們將向納斯達克提出上訴和聽證會（聽不清），納斯達克必須批准，這將暫停我們的普通股從納斯達克資本市場退市，等待納斯達克上市資格聽證會小組的決定。

There can be no assurance that the panel will grant our request for continued listing. However, we intend to present a plan to regain compliance to the panel that includes a discussion of the events that we believe will enable us to regain compliance in this time frame.

無法保證專家組會同意我們繼續上市的請求。但是，我們打算向專家組提交一份重新合規的計劃，其中包括對我們認為將使我們能夠在此時間範圍內重新合規的事件的討論。

As a reminder, sepsis presents one of the greatest challenges to healthcare systems worldwide, claiming approximately 11 million lives each year. In the United States, sepsis is the #1 cost of hospitalization, costing our healthcare system approximately $62 billion annually. The #1 cause of death in hospitals, claiming the lives of approximately 270,000 Americans annually, and another 80,000 deaths in hospital -- in hospice each year. And finally, the #1 cause of 30-day hospital readmissions, requiring nearly 20% of sepsis survivors to be readmitted within 30 days and nearly 40% to be readmitted within 90 days.

提醒一下，膿毒症是全球醫療保健系統面臨的最大挑戰之一，每年奪去大約 1100 萬人的生命。在美國，敗血症是住院治療的第一大費用，每年給我們的醫療保健系統造成大約 620 億美元的損失。醫院死亡的第一大原因，每年奪去大約 270,000 名美國人的生命，另有 80,000 人死於醫院——每年在臨終關懷中。最後，30 天再入院的第一大原因，要求近 20% 的膿毒症倖存者在 30 天內再入院，近 40% 的人在 90 天內再入院。

We are making progress to enhance the current standard of care for patients at risk of sepsis with our advanced diagnostic technology, and we continue to be uniquely positioned as the only company with FDA-cleared diagnostics to detect sepsis causing pathogens directly from whole blood samples. Our sepsis and related product revenue continues to grow, including sepsis test panels and instruments, and we expect full year growth of 2023 of 31% to 55%.

我們正在取得進展，通過我們先進的診斷技術提高對有敗血症風險的患者的當前護理標準，並且我們繼續處於獨特的地位，成為唯一一家擁有 FDA 批准的診斷技術的公司，可以直接從全血樣本中檢測引起敗血症的病原體。我們的敗血症及相關產品收入持續增長，包括敗血症測試板和儀器，我們預計 2023 年全年增長 31% 至 55%。

The demand for our products is strong, and our sales funnel continues to grow domestically and internationally. In an effort to maximize value, we also have taken important steps to reduce our operating expenses, including the restructuring program that was implemented last week. And we have engaged an advisory firm to explore all potential strategic alternatives.

對我們產品的需求強勁，我們的銷售漏斗在國內外不斷增長。為了實現價值最大化，我們還採取了重要措施來減少運營費用，包括上週實施的重組計劃。我們還聘請了一家諮詢公司來探索所有潛在的戰略選擇。

Finally, we're making excellent progress advancing our product pipeline, including several near-term programs focused on expanding test menu on the FDA-cleared T2Dx Instrument and that have the potential to add revenue as early as 2023.

最後，我們在推進我們的產品管道方面取得了很好的進展，包括幾個近期計劃，重點是在 FDA 批准的 T2Dx 儀器上擴展測試菜單，並且有可能最早在 2023 年增加收入。

I'd like to turn the call back over to the operator to open the line for questions. Operator?

我想將電話轉回接線員以打開問題熱線。操作員？

(Operator Instructions) Your first question for today is coming from Kyle Mikson at Canaccord.

（操作員說明）您今天的第一個問題來自 Canaccord 的 Kyle Mikson。

It's good to talk to you. I wanted to just kind of level set, John, on the timelines and priorities kind of going forward. I'm just -- I guess I'm curious how long it's going to take to kind of grow into your kind of relatively refreshed commercial strategy while you complete these, I guess, internal efforts to advance the pipeline assets, recognizing you have the BARDA partnership as well? And how much time at the end of the day, you want to allocate towards these buckets? And how do you think about priorities as you kind of limit cash burn as well?

很高興和你交談。約翰，我只是想在時間表和優先事項上設定一個水平。我只是 - 我想我很好奇在完成這些時需要多長時間才能發展成你那種相對更新的商業戰略，我想，內部努力推進管道資產，認識到你有BARDA 夥伴關係也是如此？在一天結束時，您想分配多少時間給這些桶？在限制現金消耗的同時，您如何考慮優先事項？

Thanks, Kyle. So the way we've set the three corporate priorities. One, obviously, is focused on commercialization. That team is in place. It's led by Brett Giffin. We have already evolved the sales team and the targets to focus on the targets that we have been prioritizing, which are some mid to critical access hospitals and supplemented that or enhanced it with a handful of large target accounts. So that's underway.

謝謝，凱爾。所以我們設定三個公司優先事項的方式。顯然，其中之一是專注於商業化。那支隊伍就位了。它由 Brett Giffin 領導。我們已經發展了銷售團隊和目標，以專注於我們一直在優先考慮的目標，這些目標是一些中等到關鍵的醫院，並通過一些大型目標客戶對其進行補充或增強。所以這正在進行中。

The comp plan has already been revised and that's under specific leadership. The internal operating initiatives around manufacturing and cost controls, and those obviously are led primarily on the cost side by John Sprague, but on the operating side by our new Vice President of Operations, that's Steve Miller. And the pipeline is led by Roger Smith.

補償計劃已經修改，並且在特定的領導下。圍繞製造和成本控制的內部運營計劃，顯然主要由 John Sprague 在成本方面領導，但在運營方面由我們新的運營副總裁 Steve Miller 領導。管道由 Roger Smith 領導。

So we have different leadership that's focused on driving these initiatives, and on balance, we can do that. We're doing it with a much leaner organization. So there are certainly some things that we have decided not to do or we've decided to slow down a bit to make sure that we can extend our cash runway appropriately.

因此，我們有不同的領導層專注於推動這些舉措，總的來說，我們可以做到這一點。我們正在通過一個更精簡的組織來做到這一點。所以肯定有一些事情我們決定不做，或者我們決定放慢一點，以確保我們可以適當地延長我們的現金跑道。

Okay. That was helpful, John. And maybe just thinking about the 11% year-over-year growth in the core product revenue, it sounded that's not overly impressive at first glance, but obviously, you have this $230,000 back order that, I guess, came through in the second quarter, but that would have been in the first. If that wasn't the first, it sounds like top line growth could have been 34%, which is solid.

好的。這很有幫助，約翰。也許僅僅考慮核心產品收入的 11% 同比增長，乍一看似乎並不過分令人印象深刻，但很明顯，你有這個 230,000 美元的延期交貨訂單，我猜，是在第二季度完成的，但那本來是第一個。如果這不是第一次，聽起來收入增長可能達到 34%，這是穩固的。

I guess, going forward, I mean, does that kind of 30-plus percent type growth for the next several quarters a good way to think about your guys' financial performance? Or I mean, just kind of -- that was kind of a one-off that back order situation. So how should we think about that variable kind of coming up in the future?

我想，展望未來，我的意思是，未來幾個季度這種 30% 以上的增長是否是考慮你們財務業績的好方法？或者我的意思是，只是有點 - 那是一種一次性的延期交貨情況。那麼我們應該如何看待未來出現的這種可變類型呢？

Sure. Well, when we set the guidance, we guided to sepsis and related product revenue of $11 million to $13 million. And we expected revenue to be weighted 40% first half and 60% second half. And then if you split those halves, we also believe that the first half would be 40% Q1 and 60% Q2, and same with the second half, 40% Q3 and 60% Q4. So at the midpoint of $12 million, we expected 16% in Q1, 24% in Q2 and Q3 and 36% in Q4. So if you look at that 16% that we expected in Q1, of the $12 million midpoint, it would have been $1.92 million. We finished at $1.7 million. We had $230 million on back order. So we are exactly where we expected to be.

當然。好吧，當我們設定指導時，我們指導敗血症和相關產品收入為 1100 萬至 1300 萬美元。我們預計上半年收入權重為 40%，下半年權重為 60%。然後，如果你把這兩半分開，我們也認為上半年是 40% Q1 和 60% Q2，下半年也是一樣，40% Q3 和 60% Q4。因此，在 1200 萬美元的中點，我們預計第一季度為 16%，第二季度和第三季度為 24%，第四季度為 36%。因此，如果你看看我們在第一季度預期的 16%，即 1200 萬美元的中點，它應該是 192 萬美元。我們以 170 萬美元的價格完成了交易。我們有 2.3 億美元的延期交貨訂單。所以我們正是我們預期的地方。

Okay. And then I guess I have a couple of questions off the kind of the guidance, I guess, too. I mean just first with like kind of a simple one on the placements. So the 5 (inaudible) definitely less than what we were modeling. But I mean that's -- it's not all bad if the installed base is increasing relatively needed rate because then you're seeing maybe utilization kind of increasing faster possibly.

好的。然後我想我也有一些關於指南的問題，我想也是。我的意思是首先在展示位置上做一個簡單的。所以 5（聽不清）肯定比我們建模的要少。但我的意思是——如果已安裝的基礎正在增加相對需要的速度，這並不是一件壞事，因為那樣你就會看到利用率可能會更快地增加。

So I mean, can you maybe just talk about what you're seeing with utilization trends as some of these customers mature with their current platform or the transition to sepsis kind of takes place and customers get more comfortable using those panels?

所以我的意思是，你能不能談談你在使用趨勢中看到的情況，因為其中一些客戶在他們當前的平台上已經成熟，或者正在向敗血症過渡，客戶使用這些面板會更加舒適？

Sure. So first thing I would say, the five instruments that were -- went to the international markets, those are all sold. So that's good news because in the United States, we typically place those instruments. They go on our balance sheet. So they have a certain cost associated with them. And it's in line with our strategy to drive sepsis test utilization.

當然。因此，首先我要說的是，這五種工具進入了國際市場，它們都已售出。所以這是個好消息，因為在美國，我們通常會放置這些儀器。他們在我們的資產負債表上。所以他們有一定的成本。這符合我們推動敗血症測試利用的戰略。

So if you look at our installed base and our sales team, the sales team has a certain amount of hours that they can be selling in customer accounts. And we've shifted that strategically to make sure that they're focus on driving increased utilization versus hunting for new accounts. Obviously, hunting for new accounts takes more time versus cultivating and growing the business in our existing accounts.

所以如果你看看我們的安裝基礎和我們的銷售團隊，銷售團隊有一定的時間可以在客戶賬戶中銷售。我們已經從戰略上改變了這一點，以確保他們專注於推動提高利用率而不是尋找新客戶。顯然，與在現有客戶中培養和發展業務相比，尋找新客戶需要更多時間。

In addition, we have those 40 instruments that were initially sold for COVID testing that we have been working to convert to sepsis testing. It's been a slower process than we anticipated, and carving out some of that sales force time so they can focus on driving those conversions are really important. And quite frankly, it's a lot more efficient use of the sales time. We'll get a much better return converting those 40 instruments that are already there than we would be putting 40 new instruments into the market at this point in time.

此外，我們擁有最初出售用於 COVID 測試的 40 台儀器，我們一直在努力將其轉換為敗血症測試。這個過程比我們預期的要慢，抽出一些銷售人員的時間，讓他們可以專注於推動這些轉化，這一點非常重要。坦率地說，它可以更有效地利用銷售時間。與我們此時將 40 種新工具投入市場相比，我們將獲得更好的回報，轉換這 40 種已經存在的工具。

Okay. That's helpful. And I guess it's actually not clear to me, this $230,000 back order, was that mainly instruments? Or is that consumables? Because that could be a few instruments possibly to, I guess, right? So I'm just curious.

好的。這很有幫助。我想我其實並不清楚，這 230,000 美元的延期交貨主要是儀器嗎？還是消耗品？因為那可能是一些工具，我想，對吧？所以我只是好奇。

It was all consumables and it was predominantly T2Candida panels and a little bit T2Bacteria.

這都是消耗品，主要是 T2Candida 面板和一點點 T2Bacteria。

Got you. Okay. So rest -- the vaccinations were placement for the rest of 2023. The five in 1Q -- I mean I appreciate the dynamics of buying and selling replacements and things like that. And it is quite the different, I guess, when you're doing U.S. versus U.S.

明白了好的。所以休息 - 疫苗接種是在 2023 年剩餘時間進行的。第一季度的五個 - 我的意思是我很欣賞買賣替代品和類似東西的動態。我猜，當你在做美國對美國時，情況就大不相同了。

But anyway, the five is the lowest since the thick of the pandemic, ,I think like early 2021. Will the rest of the '23 performance, like what's in the guidance right here from 2Q to 4Q? Is that going to be driven by instrument revenue or panel revenue in your guys' view? And how does that split between U.S. and then international look like?

但無論如何，這五個是自大流行最嚴重以來的最低點，我想是在 2021 年初。23 年的其餘表現，就像第二季度到第四季度的指導中的表現一樣嗎？在你們看來，這將由儀器收入或面板收入驅動嗎？美國和國際之間的分裂情況如何？

And then maybe if you could just comment on the pipeline product revenue. It sounds like you could include some of that you're assuming maybe some this year. Is that in this guidance, too? Because that obviously could be upside.

然後也許你可以只對管道產品收入發表評論。聽起來你可以包括一些你假設今年可能會有的東西。在本指南中也是如此嗎？因為這顯然有好處。

So there is not -- I'll just take those in different order. There is not new product revenue in the guidance. So for example, T2Lyme, or to the extent, T2Biothreat gets through FDA and is commercialized this year, that is not in our guide. That's the first thing I would say.

所以沒有-- 我只是按照不同的順序來處理這些問題。指南中沒有新產品收入。因此，例如，T2Lyme，或者在某種程度上，T2Biothreat 通過了 FDA 並在今年商業化，這不在我們的指南中。這是我要說的第一件事。

As far as instruments are concerned, the five instruments in the quarter, it's obviously less than we anticipated. We didn't guide on instruments because of the emphasis and the focus on test and test utilization, but we anticipate instruments on a quarterly basis throughout the balance of the year being higher than five per quarter.

就工具而言，本季度的五種工具明顯低於我們的預期。由於強調和關注測試和測試利用率，我們沒有對儀器進行指導，但我們預計在整個年度餘額中每季度的儀器將高於每季度 5 個。

Got you. Okay. And then if I could just ask a final one. I don't want to take too much time. But the -- maybe this 30% reduction I think that -- so that's incremental to the one that you did not too long ago, I think it was several quarters ago. Which departments were affected by this more recent reduction last week?

明白了好的。然後我能不能問最後一個。我不想花太多時間。但是 - 我認為可能減少了 30% - 所以這是你不久前所做的增量，我認為這是幾個季度前的事。上週哪些部門受到最近這次裁員的影響？

All of them.

他們全部。

Your next question is coming from Mark Massaro at BTIG.

您的下一個問題來自 BTIG 的 Mark Massaro。

Maybe just a follow-up on that last one. If all the departments were impacted, maybe could you comment, John or Brett, on what the commercial organization looks like? I know you are down to maybe three reps or so. Just what does that look like in terms of sales support, medical science liaisons and others that can help drive the top line?

也許只是最後一個的後續行動。如果所有部門都受到影響，John 或 Brett，您能否評論一下商業組織的樣子？我知道你可能只做了三個左右。在銷售支持、醫學科學聯絡員和其他有助於推動收入增長的方面，這到底是什麼樣的？

Sure, Brett, would you like to take that one?

當然可以，布雷特，你願意接受那個嗎？

Yes, sure. Can you hear me okay?

是的，當然。你能聽到我說話嗎？

Yes.

是的。

Okay. Great. Mark, thanks for the question. So yes, I mean, as John mentioned, we -- there were some impacts in the recent moves that we made. I would say that across the board, if you look at it, I think they were, I'd say, more minimized on the commercial side of things, if you just looked across the whole organization.

好的。偉大的。馬克，謝謝你的提問。所以是的，我的意思是，正如約翰提到的，我們最近採取的行動產生了一些影響。我想說的是，如果你從整體上看，我認為如果你只看整個組織，它們在商業方面的影響會最小化。

And along with that, Mark, as I talked about in prior periods, we've obviously endeavored to strengthen our medical affairs organization. We've done that, same thing with marketing with a change in leadership. Those two organizations were not affected in this latest we did actually have a couple few positions here and there across sales and service.

除此之外，馬克，正如我之前所說的，我們顯然已經努力加強我們的醫療事務組織。我們已經做到了，同樣的事情也發生在領導層發生變化的市場營銷上。這兩個組織沒有受到最近的影響，我們實際上在銷售和服務方面確實有幾個職位。

But I -- look, we feel very strongly about the team we have in place, and certainly, we were very judicious about where those moves came from. And we're in the point now, we feel very comfortable in being able to cover the account base with the right amount of focus.

但是我 - 看，我們對我們現有的團隊感覺非常強烈，當然，我們對這些舉措的來源非常明智。我們現在正處於這一點，我們對能夠以適當的關注點覆蓋客戶群感到非常自在。

So yes, I think we're -- I mean these things are always -- they have impacts, but I sort of feel like on the commercial side of it and what we're doing, that we largely minimize that.

所以是的，我認為我們 - 我的意思是這些事情總是 - 它們會產生影響，但我覺得在商業方面和我們正在做的事情上，我們在很大程度上將其最小化。

Okay. On the -- congrats on the multiyear pricing agreements with two large health systems. I'm curious if these are pricing agreements only? Or were there any purchases or any orders that went with these?

好的。關於——祝賀與兩個大型衛生系統達成多年定價協議。我很好奇這些是否只是定價協議？或者有任何購買或訂單嗎？

Their pricing difference, Mark -- go ahead, Brett.

他們的定價差異，馬克 - 繼續，布雷特。

No, I was just going to say their pricing agreements, Mark, with the -- I think with the -- I'll call it, sort of the strong emphasis on tie-in with the sort of key anchor institutions, if you will, to help drive those across the other (inaudible) institutions that's part of those networks. But yes, they're principally pricing agreements, correct.

不，我只是想說他們的定價協議，馬克，與 - 我認為 - 我會稱之為，如果你願意的話，有點強調與關鍵錨定機構的搭配，以幫助推動那些屬於這些網絡的其他（聽不清）機構。但是，是的，它們主要是定價協議，沒錯。

Yes. Okay. Is it fair to say that you would expect purchasing behavior or purchasing off of these pricing agreements as the year progresses or the quarter?

是的。好的。可以公平地說，隨著年度或季度的進展，您會期望購買行為或從這些定價協議中購買嗎？

Yes. Very much so. These are -- for licenses to hunt, so to speak, I think much more not that we couldn't have in the past, but I think with a much stronger, I'd call it, sort of tie-in and connection with the mothership, so to speak. So I think, yes, we're very bullish about targeting those within those setups.

是的。非常如此。這些是 - 狩獵許可證，可以這麼說，我認為我們過去不能擁有更多，但我認為有更強大的，我會稱之為，某種搭配和聯繫母艦，可以這麼說。所以我認為，是的，我們非常看好針對這些設置中的那些人。

Okay. Great. So I guess, you guys have had a relatively low cash balance in the last couple of quarters. I'm a little bit surprised -- modestly surprised to see the news on the strategic alternative pursuit.

好的。偉大的。所以我想，你們在過去幾個季度的現金餘額相對較低。我有點驚訝 - 看到關於戰略替代追求的消息有點驚訝。

Maybe can you guys comment -- I think there's a statement in your queue that you believe that you may not have enough cash. Let me -- may not have enough cash, I think, to get through June 30 or July yet to fund its operating plans through June 30. So I'm trying to figure out, has the cash burn spiked a little bit? Were there any one-timers?

也許你們可以發表評論——我認為你們的隊列中有一個聲明，你們認為你們可能沒有足夠的現金。讓我 - 我認為可能沒有足夠的現金來度過 6 月 30 日或 7 月尚未為其運營計劃提供資金到 6 月 30 日。所以我想弄清楚，現金消耗是否有點飆升？有一次性的嗎？

And then how much of the decision to pursue strategic alternatives is around the uncertainty on the no-cost extension from BARDA? I guess what I'm trying to figure out is if BARDA does extend you, how do you expect that might impact your funding situation in the next several months?

那麼尋求戰略替代方案的決定有多少是圍繞 BARDA 的免費延期的不確定性？我想我想弄清楚的是，如果 BARDA 確實延長了你的期限，你認為這會對你未來幾個月的資金狀況產生怎樣的影響？

So I'll let John take the cash question. But I would just address the one about pursuing potential strategic alternatives. It's completely unrelated to BARDA.

所以我讓約翰回答現金問題。但我只想解決關於尋求潛在戰略選擇的問題。它與 BARDA 完全無關。

Yes. And just to add to the cash burn. Our cash burn has come down consistently, Mark, as we've leveraged operations as well as it's going to be benefited by the reduction in force. We do have some seasonality in terms of our procurement purchases for pricing in our supply chain. You see that typically in Q1 and then it levels off during the rest of the year. But overall, going forward, we expect our burn to be significantly decreased as a result of all these efforts.

是的。並且只是為了增加現金消耗。馬克，我們的現金消耗一直在下降，因為我們已經利用了運營，而且它將因裁員而受益。在我們的供應鏈定價採購採購方面，我們確實有一些季節性。您通常會在第一季度看到這種情況，然後在今年餘下時間趨於平穩。但總的來說，展望未來，我們預計由於所有這些努力，我們的燃燒將大大減少。

Mark, I'll just add to that. I mean the going concern language in our 10-Q that we filed yesterday, that's not the first time that we've had going concern language because as you noted, our cash balance has been relatively lean on a sort of quarterly basis over the last 12 months.

馬克，我會補充一點。我的意思是我們昨天提交的 10-Q 中的持續經營語言，這不是我們第一次使用持續經營語言，因為正如您所指出的，我們的現金餘額在過去的季度基礎上相對較少12個月。

Okay. I guess, I think you've touched on this, but maybe I'll just make sure we're all on the same page. Saying you're not going to have enough cash to get through June and then reiterating the full year sepsis guidance range of 11% to 13% after doing a nearly 30% reduction in force, I guess, what gives you confidence that you can still hit those numbers this year?

好的。我想，我想你已經談到了這一點，但也許我會確保我們都在同一頁面上。說你沒有足夠的現金來度過 6 月，然後在減少近 30% 的力量後重申 11% 到 13% 的全年敗血症指導範圍，我想，是什麼讓你有信心你仍然可以今年達到那些數字？

Well, I think what that language says is that we're going to need to raise capital.

好吧，我認為那句話說的是我們將需要籌集資金。

Yes. Understood, which is also clear. So all right. Well, congrats on the growth in the T2Bacteria, especially in the U.S. I guess maybe my last question, John, I guess, can you explain what drove the triple-digit year-over-year revenue growth in T2Bacteria. Were these predominantly the four new hospitals that came on? Or maybe can you just give us a sense for where that strength came from and what your near-term pipeline looks like to turn on T2Bacteria?

是的。明白了，這也清楚了。所以好吧。好吧，祝賀 T2Bacteria 的增長，尤其是在美國。我想也許是我的最後一個問題，約翰，我想，你能解釋一下是什麼推動了 T2Bacteria 的收入同比增長三位數。這些主要是四家新醫院嗎？或者，也許您能否讓我們了解這種力量來自何處，以及您近期開啟 T2Bacteria 的管道是什麼樣的？

Sure. I'll start, and then Brett might want to add to it. It certainly was a factor that we had four accounts come online. I'd say it's also a result of our renewed or modified sales strategy to focus on driving broader adoption within these hospital accounts and the fact that keep in mind, the T2Bacteria launch happens shortly before the COVID pandemic. So I don't think that hospital accounts have had the full benefit of our sales and marketing team and our Scientific Advisory Board members [championing] the value of T2Bacteria, and we're starting to see the impact of that. So Brett, do you want to add anything to add?

當然。我先開始，然後 Brett 可能想添加內容。這當然是我們有四個帳戶上線的一個因素。我想說這也是我們更新或修改銷售策略的結果，該策略專注於推動這些醫院賬戶中更廣泛的採用，而且請記住，T2Bacteria 的發布發生在 COVID 大流行之前不久。因此，我認為醫院賬戶並沒有充分受益於我們的銷售和營銷團隊以及我們的科學顧問委員會成員[擁護] T2Bacteria 的價值，我們開始看到它的影響。布雷特，你想補充什麼嗎？

Yes, I think that's correct. And Mark, you probably might recall, too, we've been seeing a really solid lift in bacteria going back into last year, I mean the second half of last year. And I think we've continued to accelerate that at obviously adding the -- our medical affairs resources that we now have in place and having that integrated along, as I mentioned, with the marketing group and the sales all working together.

是的，我認為這是正確的。馬克，你可能還記得，我們一直看到細菌數量在去年出現了真正的增長，我的意思是去年下半年。而且我認為我們在明顯增加 - 我們現在擁有的醫療事務資源並將其整合在一起，正如我提到的那樣，與營銷團隊和銷售人員一起工作，從而繼續加速這一進程。

I think it's -- yes, I mean it's really borne a lot of fruit. And it's a combination. We've certainly seen good solid lift within the legacy accounts, both in the U.S. as well as internationally. And again, as John mentioned, adding to that the new accounts that we've brought on are -- we're certainly seeing and experiencing the impact of that. So that's been a great picture, and I think that's certainly one we're bullish on going forward, too.

我認為它——是的，我的意思是它真的結出了很多果實。這是一個組合。在美國和國際上，我們當然已經看到遺留賬戶的穩固增長。再一次，正如約翰提到的那樣，加上我們帶來的新賬戶——我們當然看到並經歷了它的影響。所以這是一幅很棒的圖景，我認為這當然也是我們看好未來的圖景。

Your next question is coming from Ben Haynor at Alliance Global.

您的下一個問題來自 Alliance Global 的 Ben Haynor。

First off for me, congrats on completing the assay development for the T2Lyme. What's left to do there before launch? And is this something that you're going to launch yourself or look to a partner? And does the present balance sheet situation make you lean more towards a partner? If there's some upfront money potentially available? Just any help there would be helpful.

首先對我來說，祝賀您完成了 T2Lyme 的檢測開發。在發布之前還有什麼要做的？這是您要自己推出還是尋求合作夥伴的東西？目前的資產負債表情況是否讓您更傾向於合作夥伴？如果有一些可能可用的前期資金？任何幫助都會有所幫助。

Thanks, Ben, for the question. We have to do a little bit of work on the instrument side to make sure that we marry that with the assay development work that's gone on. I think the really important point to underscore on the limit of detection that I described, that preliminary LOD of 2 CFU per ml, that's really critical because our focus from a marketing perspective is on early line disease in that first 30 days, because the alternative tests that are in the market are relying on antibodies that take time to develop.

謝謝，本，提出這個問題。我們必須在儀器方面做一些工作，以確保我們將其與正在進行的分析開發工作結合起來。我認為真正重要的一點是要強調我描述的檢測限度，即每毫升 2 CFU 的初步 LOD，這非常關鍵，因為從營銷的角度來看，我們的重點是前 30 天的早期線疾病，因為替代方案市場上的測試依賴於需要時間開發的抗體。

So this is in line with our strategy where rapid detection is important for targeted treatment. From a commercial perspective, you covered both areas, which is, are we going to do this ourselves? Are we going to do it through a partner? We're exploring both opportunities, and we haven't decided at this point.

因此，這符合我們的戰略，即快速檢測對於靶向治療很重要。從商業的角度來看，你涵蓋了這兩個領域，也就是說，我們要自己做嗎？我們要通過合作夥伴來做嗎？我們正在探索這兩個機會，目前還沒有做出決定。

Okay. And are you having -- I presume there's some discussions going on, certainly, internal EBIT are you also discussing with potential partners and have kind of engagements there?

好的。你是否有——我想正在進行一些討論，當然，內部息稅前利潤你是否也在與潛在合作夥伴討論並在那裡進行某種接觸？

Yes, we are.

是的我們是。

Okay. Got it. I'll stay tuned there. And then on the 30% reduction in force, what's the right way to think about that in terms of expenses? I mean is it kind of a 30% reduction in OpEx as well? And then will there be any sort of charge in the current quarter and what does that look like?

好的。知道了。我會繼續關注那裡。然後關於減少 30% 的兵力，從開支的角度考慮這個問題的正確方法是什麼？我的意思是運營支出也減少了 30% 嗎？然後在當前季度會有任何形式的收費嗎？那是什麼樣的？

There's no charge in the current quarter. John Sprague, would you take the forward-looking OpEx, give Ben some insight on that?

當前季度不收費。 John Sprague，你能否接受具有前瞻性的 OpEx，讓 Ben 對此有所了解？

Yes. I think it's fair to model somewhere between 20% and 30%, Ben. It is skewed based on the mix of employees that were impacted. But I think that that's a good way to view our burn improvement going forward.

是的。我認為在 20% 到 30% 之間建模是公平的，本。它因受到影響的員工組合而有所偏差。但我認為這是查看我們未來燃燒改進的好方法。

Okay. Got it. And then lastly for me, and I'll take the rest offline. But the T2Resistance trial getting down to the short strokes here, what does that completing trigger any payment for BARDA? Or does that require them picking up option for to have some more cash come in the door?

好的。知道了。最後是我，剩下的我會離線處理。但是 T2Resistance 試驗在這裡進行了短行程，完成後會觸發 BARDA 的任何付款嗎？或者這是否需要他們選擇獲得更多現金的選擇權？

So I'd say first thing, we're super excited about both T2Biothreat and T2Resistance. Remember, we came into this year anticipating getting two products over the goal line submitted to the FDA that could potentially be revenue contributors this year. And we have submitted T2Biothreat to the FDA. So that 90-day clock is now ticking. The FDA will respond to us sometime in mid-August, if not sooner. And we're excited about that.

所以我首先要說的是，我們對 T2Biothreat 和 T2Resistance 都非常興奮。請記住，今年我們預計將有兩種產品超過提交給 FDA 的目標線，這可能是今年的收入貢獻者。我們已經向 FDA 提交了 T2Biothreat。所以 90 天的時鐘現在正在滴答作響。 FDA 將在 8 月中旬的某個時間給我們回复，如果不是更早的話。我們對此感到興奮。

We're also excited about T2Resistance. We're close to the goal line on completing the clinical trial. We're 90% at this point. And we are under a no-cost extension. So from a BARDA perspective, we don't anticipate additional funding for T2Resistance.

我們也對 T2Resistance 感到興奮。我們接近完成臨床試驗的目標線。我們現在已經完成了 90%。我們正在免費延期。因此，從 BARDA 的角度來看，我們預計不會為 T2Resistance 提供額外資金。

Once we complete Option 3, as I mentioned in the earlier prepared remarks, that would be a point where BARDA may potentially trigger payment under Option 4, and then there was also a contemplated Option 5 and Option 6. Those, again, assuming BARDA funds them, would be for the next-gen instrument and comprehensive sepsis panel.

一旦我們完成選項 3，正如我在之前準備好的評論中提到的那樣，BARDA 可能會根據選項 4 觸發付款，然後還有一個預期的選項 5 和選項 6。再次假設 BARDA 資金他們，將用於下一代儀器和綜合敗血症小組。

We have reached the end of the question-and-answer session, and I will now turn the call over to John Sperzel for closing remarks.

問答環節已經結束，我現在將把電話轉給 John Sperzel 作結束語。

Thank you very much for joining our first quarter 2023 earnings call. Hope you all have a great day.

非常感謝您參加我們 2023 年第一季度的財報電話會議。希望你們都有美好的一天。

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束，此時您可以斷開您的線路。感謝您的參與。