T2 Biosystems Inc (TTOO) 2024 Q3 法說會逐字稿

Greetings, welcome to the T2 Biosystems Incorporated third quarter, 2024 earnings conference call.

大家好，歡迎參加 T2 Biosystems Incorporated 2024 年第三季財報電話會議。

(Operator Instructions)

（操作員指示）

Please note this conference is being recorded. I will now turn the conference over to your host, Philip Taylor with investor relations. You may begin.

請注意，本次會議正在錄製。現在我將會議交給主持人、投資者關係部門 Philip Taylor。你可以開始了。

Thank you. Operator. I'd 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.

謝謝。操作員。我想提醒大家，管理階層今天發表的評論和對問題的回答將包括前瞻性陳述。其中包括與 T2 Biosystems、未來財務和經營業績以及開發和行銷新產品的計劃相關的聲明。

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 April 1, 2024 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.

前瞻性聲明是基於截至今天的估計和假設，並受風險和不確定性的影響，這些風險和不確定性可能導致實際結果與這些陳述明示或暗示的結果存在重大差異，包括 T2 Biosystems 於 2024 年 4 月 1 日向美國證券交易委員會提交的 10-K 表格年度報告以及公司不時向美國證券交易委員會描述的其他文件中描述的法律不相關，除非不承擔任何經驗的風險，除非向美國證券交易委員會提交證據。

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

我想將電話轉給董事長兼執行長約翰‧斯珀澤爾 (John Sperzel)。

Thank you all for joining our third quarter, 2024 results call.

感謝大家參加我們的 2024 年第三季業績電話會議。

I'll start by discussing our recent highlights and providing an update on the progress across our three corporate priorities. Before turning the call over to John Sprague, our Chief Financial Officer who will review our financial results. I will then provide closing remarks before opening the call for questions and answers.

我將首先討論我們最近的亮點，並提供我們三個公司優先事項的進展。在將電話轉交給我們的財務長 John Sprague 之前，他將審查我們的財務結果。然後，我將在開始問答環節之前致結束語。

T2 Biosystems is focused primarily on sepsis and I will remind everyone that sepsis continues to take an enormous human and economic toll. Sepsis is the leading cause of death in us hospitals and claims the lives of approximately 350,000 Americans annually.

T2 Biosystems 主要關注敗血症，我要提醒大家，敗血症持續對人類和經濟造成巨大的損失。敗血症是美國醫院死亡的主要原因，每年奪走約 35 萬名美國人的生命。

Sepsis represents the leading cost of hospitalization in the United States costing our health care system an estimated $62 billion annually.

敗血症是美國住院費用最高的疾病，每年對醫療保健系統造成約 620 億美元的損失。

Lastly, sepsis is the leading cause of 30-day hospital readmission in the United States. With 19% of sepsis survivors re-hospitalized within 30 days and 40% within 90 days. On previous earnings calls, I've described the limitations of blood culture-based diagnostics which are the current standard of care for the management of patients suspected of sepsis.

最後，敗血症是美國 30 天內再次入院的主要原因。19% 的敗血症倖存者在 30 天內再次入院，40% 的倖存者在 90 天內再次入院。在先前的收益電話會議上，我描述了基於血液培養的診斷的局限性，而血液培養診斷是目前對疑似敗血症患者的護理標準。

Relying on blood culture as a clinical specimen for patients at risk of sepsis represents several challenges including poor sensitivity which can lead to false negative results or missed infections and slow time to results typically 1 day to 5 days.

對於有敗血症風險的患者，依靠血液培養作為臨床標本存在一些挑戰，包括敏感性差，這可能導致假陰性結果或漏診感染，結果產生時間通常需要 1 天到 5 天。

Despite these shortcomings, blood culture remains as a standard of care for patients at risk of sepsis. And except for T2 Biosystems sepsis products, all other FDA cleared products authorized for pathogen detection or antibiotic resistance testing require a positive blood culture as the clinical specimen, these blood culture dependent diagnostic products which include virtually all of our competitors in this space, provide little to no clinical value if blood culture yields a false negative result due to poor sensitivity or blood culture is not available due to supplier issues.

儘管有這些缺點，血液培養仍然是敗血症風險患者的照護標準。除了 T2 Biosystems 敗血症產品外，所有其他經 FDA 批准用於病原體檢測或抗生素抗藥性測試的產品都需要陽性血液培養作為臨床標本，這些依賴於血液培養的診斷產品（幾乎包括我們在這個領域的所有競爭對手）如果血培養由於敏感性差而產生假陰性結果或由於供應商問題而無法進行血液培養，則幾乎沒有臨床價值。

The recent BD BACTEC blood culture supply interruption which led to customer letters from the US, food and drug administration and the US centers for disease control and prevention or CDC.

最近，BD BACTEC 血液培養供應中斷，導緻美國食品藥物管理局和美國疾病管制與預防中心（CDC）向客戶致函。

And resulted in blood culture media bottles being added to the medical device shortage list underscores the risk of creating guidelines based on a single diagnostic technology that is blood culture.

並導致血液培養瓶被添加到醫療器材短缺名單中，凸顯了基於血液培養單一診斷技術制定指南的風險。

We believe this is the perfect time to lobby for changes to the guidelines to include diagnostic products that are able to detect bacterial and fungal pathogens and antibiotic resistance genes directly from blood independent of blood culture.

我們認為，現在是遊說修改指南的最佳時機，將能夠直接從血液中檢測細菌和真菌病原體以及抗生素抗藥性基因的診斷產品納入其中，而無需依靠血液培養。

And we are actively lobbying for such changes in response to this critical supply situation a manuscript titled Quote, changing the culture of blood culture end quote was recently published in the lancet, a world leading medical journal. It highlights the potential for culture independent diagnostics like the T2bacteria panel, the T2Candida panel and the T2resistance panel to complement and improve the existing protocols for patients suspected of sepsis.

為了應對這一嚴峻的供應情勢，我們正在積極遊說各方做出此類改變。一篇題為《改變血液培養的文化》的手稿最近發表在世界領先的醫學雜誌《柳葉刀》上。它強調了 T2 細菌組、T2 念珠菌組和 T2 抗性組等獨立培養診斷方法的潛力，可以補充和改善疑似敗血症患者的現有治療方案。

T2 Biosystems has developed and is commercializing a technology that is designed to address the challenges associated with the other diagnostics used to detect sepsis causing pathogens and antibiotic resistance.

T2 Biosystems 已經開發並正在商業化一項技術，旨在解決與檢測引起敗血症的病原體和抗生素抗藥性的其他診斷方法相關的挑戰。

We provide the only FDA clear diagnostics able to detect sepsis causing pathogens directly from whole blood without the need to wait days for a positive blood culture.

我們提供唯一獲得 FDA 明確認證的診斷方法，能夠直接從全血中檢測出導致敗血症的病原體，而無需等待數天才能獲得陽性血液培養結果。

The combination of our FDA cleared T2DX instrument, T2bacteria panel and T2Candida panel can detect sepsis causing bacterial and fungal pathogens in 3 hours to 5 hours directly from blood. No, other company in the world can make that claim.

我們經 FDA 批准的 T2DX 儀器、T2bacteria 面板和 T2Candida 面板的組合可以在 3 小時到 5 小時內直接從血液中檢測出導致敗血症的細菌和真菌病原體。不，世界上其他公司也不能提出這樣的主張。

It's important to note that our expanded T2bacteria panel which now includes the detection of [AACR Bania] covers approximately 75% of all sepsis causing bacterial pathogens commonly found in bloodstream infections. Likewise, our T2Candida panel covers approximately 90% of Canada's species commonly found in bloodstream infections.

值得注意的是，我們擴展的 T2bacteria 面板現在包括對 [AACR Bania] 的檢測，涵蓋了血液感染中常見的所有導致敗血症的細菌病原體的約 75%。同樣，我們的 T2Candida 小組涵蓋了加拿大血液感染中常見的約 90% 的菌種。

Now turning to review the progress we have made across our three corporate priorities, accelerating our sales, enhancing our operations and advancing our pipeline. Starting with our first corporate priority, accelerating our sales, In the US market our commercial team continues to prioritize increasing sales of our sepsis test panels.

現在回顧我們在三家公司重點方面的進展，即加速銷售、加強營運和推進通路建設。從我們的首要企業重點開始，加速我們的銷售，在美國市場，我們的商業團隊繼續優先考慮增加敗血症測試面板的銷售。

The T2 Biosystems team generated third quarter revenue of $2.0 million representing 34% growth compared to the prior year period, growth was driven by $1.4 million of sepsis test panel revenue that included a 173% increase in the sales of T2bacteria panel in the US market.

T2 Biosystems 團隊第三季的營收為 200 萬美元，比去年同期成長 34%，成長主要得益於 140 萬美元的敗血症測試面板收入，其中包括美國市場 T2bacteria 面板銷售額成長 173%。

During the third quarter, we executed contracts for 11 T2DX instruments including one in the United States and 10 internationally. The international contracts helped drive a 78% increase in sales of the T2DX instrument compared to the third quarter of 2023.

第三季度，我們執行了 11 個 T2DX 工具合約，其中一個在美國，另外 10 個在國際上。與 2023 年第三季相比，國際合約推動 T2DX 工具的銷售額成長了 78%。

To strengthen our us commercialization efforts with our sepsis products and capitalize on what we believe is a significant opportunity to improve the standard of care. We're extremely pleased to have entered into an exclusive commercial distribution agreement with Cardinal Health. Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products and a provider of performance and data solutions for health care facilities.

加強我們在敗血症產品方面的商業化努力，並利用我們認為的提高護理標準的重要機會。我們非常高興與 Cardinal Health 達成獨家商業分銷協議。康德樂是一家藥品分銷商、醫療和實驗室產品的全球製造商和分銷商，也是醫療機構性能和數據解決方案的提供者。

Cardinal Health trades on the New York Stock Exchange under the symbol CAH as annual revenue of more than $200 billion has operations in more than 30 countries and has approximately 48,000 employees.

康德樂健康公司在紐約證券交易所上市，股票代號為 CAH，年收入超過 2,000 億美元，業務遍及 30 多個國家，約有 48,000 名員工。

Cardinal Health is one of the largest health care companies in the United States and sells to 90% of us hospitals through its extensive commercial organization and holds contracts with a large number of US group purchasing organizations or GPOs.

康德樂公司是美國最大的醫療保健公司之一，透過其廣泛的商業組織向美國90%的醫院銷售產品，並與大量美國集團採購組織或GPO簽訂合約。

Cardinal Health's reach includes the 200 plus children's hospitals in the United States which we are now targeting following the recent T2Candida panel FDA clearance for use in pediatric patients. Our agreement grants Cardinal Health exclusive rights to the only FDA cleared direct from blood pathogen detection products.

康德樂的業務範圍包括美國 200 多家兒童醫院，在 T2Candida 檢測試劑盒最近獲得 FDA 批准用於兒科患者後，我們目前正瞄準這些醫院。我們的協議授予 Cardinal Health 對唯一獲得 FDA 批准的直接血液病原體檢測產品的獨家權利。

In addition to the economic benefits, having access to T2 Biosystems direct from blood diagnostics, strengthens cardinal health's product offering to microbiology laboratories.

除了經濟效益之外，直接從血液診斷中獲得 T2 Biosystems 的支持，也增強了康德樂向微生物實驗室提供產品的能力。

We believe our agreement with Cardinal Health will be transformative with the objectives of accelerated revenue growth and a faster path to profitability by expanding our access to the more than 6,000 US hospitals.

我們相信，我們與 Cardinal Health 的協議將帶來變革，透過擴大我們在美國 6,000 多家醫院的覆蓋範圍，我們的目標是加速收入成長並更快地實現盈利。

We expect the exclusive nature of the agreement to align interest and motivate the cardinal commercial team and give Cardinal a competitive advantage vis a vis their competitors. While the terms of our agreement with Cardinal Health are confidential in general, the economics and logistics are similar to those we have with our international distributors. For example, T2 Biosystems will sell our FDA cleared products to Cardinal Health including the T2DX instrument, the T2bacteria panel, and the T2Candida panel and Cardinal Health will sell these products to US hospitals.

我們期望該協議的排他性能夠協調利益、激勵紅衣主教商業團隊，並使紅衣主教在相對於競爭對手的競爭中佔據優勢。雖然我們與 Cardinal Health 的協議條款一般是保密的，但其經濟和物流與我們與國際分銷商的協議類似。例如，T2 Biosystems 將向 Cardinal Health 出售我們經 FDA 批准的產品，包括 T2DX 儀器、T2bacteria 面板和 T2Candida 面板，而 Cardinal Health 則將這些產品出售給美國醫院。

We expect this collaboration to greatly expand our access to the US hospital market. As Cardinal Health has an extensive commercial and distribution infrastructure including capital equipment specialists who will sell the T2DX instrument.

我們期望此次合作能大大擴展我們進入美國醫院市場的機會。由於 Cardinal Health 擁有廣泛的商業和分銷基礎設施，包括將銷售 T2DX 儀器的資本設備專家。

At this point, we've trained the team at Cardinal to fully understand the science behind our technology, its features and benefits and the clinical and economic value it offers to customers.

目前，我們已經對 Cardinal 的團隊進行了培訓，使他們充分了解我們技術背後的科學、其特點和優勢以及它為客戶提供的臨床和經濟價值。

Our products are now established in the cardinal health ecosystem. They're in the process of launching the initial sales campaigns and our teams have begun working together in the field.

我們的產品現已在康得樂健康生態系統中建立。他們正在啟動初步銷售活動，我們的團隊已經開始在該領域合作。

In the United States. We recently announced a co-marketing collaboration with precision Inc aimed at pioneering a new frontier in antibiotic stewardship to combat the growing threat of antimicrobial resistance.

在美國。我們最近宣布與 precision Inc 進行聯合行銷合作，旨在開拓抗生素管理的新領域，以應對日益嚴重的抗菌素抗藥性威脅。

Antibiotic resistance is one of the greatest threats facing modern medicine with millions of lives at risk. Over 1.27 million deaths are reported annually due to antimicrobial resistance or AMR which threatens to render essential antibiotics useless.

抗生素抗藥性是現代醫學面臨的最大威脅之一，數百萬人的生命處於危險之中。每年有超過 127 萬人因抗生素抗藥性（AMR）而死亡，這可能導致基本抗生素失效。

The stakes are high, and time is critical, each hour of delayed targeted treatment can increase the risk of death by up to 8% for sepsis patients. Precision is a New York based private company that is leveraging two decades of expertise in antibiotic development to create a real time AI powered decision support platform.

風險很高，時間至關重要，針對性治療每延遲一小時就會使敗血症患者的死亡風險增加高達 8%。Precision 是一家位於紐約的私人公司，利用二十年的抗生素開發專業知識來創建即時人工智慧決策支援平台。

The product also called Precision is integrated with electronic health records, for example, Epic and Cerner and provides clinicians with ranked evidence based antibiotic regimens tailored to each patient's needs. This approach can potentially stop antibiotic misuse, break the cycle of resistance, reduce health care costs and ultimately save lives.

該產品也稱為 Precision，與 Epic 和 Cerner 等電子健康記錄集成，並為臨床醫生提供根據每位患者的需求量身定制的基於證據的抗生素治療方案。這種方法可以潛在地阻止抗生素的濫用，打破抗藥性循環，降低醫療成本，並最終挽救生命。

We believe that artificial intelligence or AI will have an important and increasing role in health care delivery and specifically in the management of patients at risk of sepsis. AI can be used to diagnose diseases, develop personalized treatment plans and assist clinicians with decision making.

我們相信，人工智慧或 AI 將在醫療保健領域，特別是在敗血症風險患者的管理中發揮重要且日益重要的作用。人工智慧可用於診斷疾病、制定個人化治療方案並協助臨床醫生做出決策。

At T2 Biosystems we have been searching for an AI powered decision support platform to combine with our rapid direct for blood diagnostics. The precision platform is designed to leverage data from diagnostics such as our T2DX instrument and test panels to provide another level of precision using advanced pharmacokinetic models, pathogen profiles and real time patient data to enable clinicians to prescribe the right drug, right dose and right duration. As the patient's condition evolves, the platform adapts continuously to changing clinical information, providing ranked evidence-based treatment regimens that help clinicians optimize care and improve outcomes.

在 T2 Biosystems，我們一直在尋找一個由人工智慧驅動的決策支援平台，以便與我們的快速直接血液診斷相結合。此精準平台旨在利用我們的 T2DX 儀器和測試面板等診斷數據，使用先進的藥物動力學模型、病原體概況和即時患者數據提供更高水平的精確度，使臨床醫生能夠開出正確的藥物、正確的劑量和正確的療程。隨著患者病情的發展，該平台不斷適應不斷變化的臨床訊息，提供排名的循證治療方案，幫助臨床醫生優化護理並改善治療效果。

By combining our direct from blood diagnostics with the AI Driven Precision platform. We believe we can empower clinicians with the information to stop infections in their tracks faster than ever before. Beyond improving patient care, this collaboration is intended to drive product adoption and create exciting opportunities for growth in a rapidly evolving market with speed and accuracy at its core, we believe the combined solution can provide hospitals with a powerful tool to improve outcomes and reduce costs.

透過將我們的直接血液診斷與 AI 驅動的精準平台結合。我們相信，我們可以為臨床醫生提供信息，使他們能夠比以往更快地阻止感染。除了改善患者護理之外，此次合作還旨在推動產品採用，並在以速度和準確性為核心的快速發展的市場中創造令人興奮的成長機會，我們相信綜合解決方案可以為醫院提供強大的工具來改善結果並降低成本。

We're really excited about our new initiatives with Cardinal Health and precision, and we believe each will contribute meaningfully to revenue in 2025 and beyond. In international markets, we continue to execute on our plan to expand our commercial footprint by entering into territory exclusive distribution agreements to market and sell our products including the T2DX instrument, the T2bacteria panel, the T2Candida panel and the T2resistance panel.

我們對與 Cardinal Health 和 Precision 合作的新舉措感到非常興奮，我們相信每項舉措都將為 2025 年及以後的收入做出有意義的貢獻。在國際市場上，我們繼續執行擴大商業足蹟的計劃，透過簽訂區域獨家分銷協議來行銷和銷售我們的產品，包括 T2DX 儀器、T2 細菌面板、T2 念珠菌面板和 T2 抗性面板。

During the third quarter, we entered into new distribution agreements covering Malaysia and Indonesia as indicated by our executed international instrument contracts. This expansion is already proving valuable outside of sepsis. We're making progress toward commercialization of our T2bacteria panel and T2line panel.

在第三季度，我們簽訂了涵蓋馬來西亞和印尼的新分銷協議，正如我們簽署的國際儀器合約所示。這種擴展已被證明在敗血症之外具有價值。我們正在朝著 T2bacteria 面板和 T2line 面板的商業化方向取得進展。

We're identifying strong potential government targets and fielding interest to procure the T2biothreat panel.

我們正在確定強有力的潛在政府目標，並引起採購 T2biothreat 面板的興趣。

We've presented to multiple us government agencies organized by the administration for strategic preparedness and response or Asper and have ongoing discussions with leading biothreat response laboratories in the United States regarding their interest in the T2biothreat panel, we believe the unique attributes of the T2biothreat panel covered with it being the only FDA cleared multi target biothreat panel developed and manufactured in the United States will be of interest under the new administration.

我們已經向戰略準備和響應管理局 (Asper) 組織的多個美國政府機構進行了介紹，並與美國領先的生物威脅響應實驗室就他們對 T2biothreat 面板的興趣進行了持續討論，我們相信，T2biothreat 面板所涵蓋的獨特屬性（它是唯一獲得 FDA 批准的在美國開發和製造的多目標生物威脅面板）將引起新政府的興趣。

Finally, we maintain our plan to launch the T2Lyme panel as a laboratory developed test or LDT And we anticipate initiating commercialization by the start of the 2025 season.

最後，我們堅持將 T2Lyme 面板作為實驗室開發的測試或 LDT 推出的計劃，並且我們預計在 2025 年賽季開始時啟動商業化。

Moving to our second corporate priority, enhancing our operations operationally, we have converted approximately 80% of our debt to common stock over the past 12 months to 18 months, which strengthens our balance sheet and significantly reduces our quarterly interest payments.

談到我們的第二個公司重點，即加強運營，我們在過去 12 個月到 18 個月內將大約 80% 的債務轉換為普通股，這增強了我們的資產負債表並顯著減少了我們的季度利息支付。

We're focused on strengthening our task position and making further improvements to our cost structure. As you'll see in our 10-Q filing, we have used our at the market or ATM facility intermittently to raise capital during the third quarter and early fourth quarter of 2024. We're continuing to explore other sources of capital, and we are actively engaged with potential strategic investors or partners.

我們專注於加強我們的任務地位並進一步改善我們的成本結構。正如您在我們的 10-Q 文件中看到的，我們在 2024 年第三季和第四季初間歇性地使用了市場或 ATM 工具來籌集資金。我們正在繼續探索其他資金來源，並積極與潛在的策略投資者或合作夥伴接洽。

During the third quarter of 2024 we began partnering with ADP total source as our professional employer organization or PEO to provide comprehensive and cost-effective HR solutions including health care benefits, workers' compensation, payroll, and tax support and HR guidance. We expect this change to result in annualized savings of at least $400,000.

在 2024 年第三季度，我們開始與 ADP total source 合作，作為我們的專業雇主組織或 PEO，提供全面且經濟高效的人力資源解決方案，包括醫療保健福利、工人賠償、工資和稅收支持以及人力資源指導。我們預計這項變更每年將節省至少 40 萬美元。

During the third quarter of 2024 we reduced our inventory by leveraging our new oracle ERP system to drive better demand planning and material management. We believe the oracle ERP expansion will continue to favourably impact inventory levels, cost of goods sold and ultimately improve cash flow.

2024 年第三季度，我們利用新的 Oracle ERP 系統來推動更好的需求規劃和物料管理，從而減少了庫存。我們相信 Oracle ERP 擴充將繼續對庫存水準、銷售成本產生正面影響，並最終改善現金流。

Finally, in the first quarter of 2025 we plan to further consolidate our real estate space by exiting our facility at four Hartwell Avenue in Lexington Mass and consolidating those operations into our headquarters at 101, Hartwell Ave in Lexington Mass. We expect this action to reduce our facilities cost by approximately $1 million annually.

最後，在 2025 年第一季度，我們計劃進一步整合我們的房地產空間，退出位於馬薩諸塞州列剋星敦哈特韋爾大道 4 號的設施，並將這些業務整合到位於馬薩諸塞州列剋星敦哈特韋爾大道 101 號的總部。我們預計這項措施每年將減少我們的設施成本約 100 萬美元。

Moving to our third corporate priority, advancing our pipeline. Our pipeline initiatives are focused on expanding the test menu for our T2DX instrument. There are four test expansion programs in our pipeline including the US T2Resistance panel, the T2line panel, the expanded T2Candida panel to include detection of can AIS and the expanded T2bacteria panel to include a claim for pediatric testing.

轉到我們的第三個公司重點，推進我們的管道建設。我們的管道計劃專注於擴展我們的 T2DX 儀器的測試菜單。我們的管道中有四個測試擴展程序，包括美國 T2Resistance 面板、T2line 面板、擴展的 T2Candida 面板（包括檢測 AIS）和擴展的 T2bacteria 面板（包括兒科測試索賠）。

Three of these programs have already received FDA breakthrough device designation including the T2Resistance panel, the teacher line panel and the candidate or test which should provide for a straightforward path to market and help solve an unmet need for rapid detection of these respective target biomarkers.

其中三個項目已經獲得 FDA 突破性設備稱號，包括 T2Resistance 面板、教師線面板和候選或測試，這應該提供一條直接的市場途徑，並有助於解決對這些各自目標生物標誌物的快速檢測的未滿足需求。

The US T2resistance panel is a CE marked diagnostic test able to detect antibiotic resistance genes directly from blood in just 3 hours to 5 hours. The T2resistance panel simultaneously detects 13 antibiotic resistance genes from both gram positive and gram negative bacterial passages.

美國 T2resistance 檢測組是一種 CE 標誌的診斷測試，能夠在短短 3 至 5 小時內直接從血液中檢測出抗生素抗藥性基因。T2resistance 面板同時檢測來自革蘭氏陽性和革蘭氏陰性細菌通道的 13 種抗生素抗藥性基因。

The T2Resistance panel is marketed and sold in Europe under a CE mark and as I mentioned earlier, has received breakthrough device designation which will provide for a prioritized form 10-K review process.

T2Resistance 面板在歐洲以 CE 標誌進行行銷和銷售，正如我之前提到的，它已獲得突破性設備稱號，這將提供優先的 10-K 表格審查流程。

We expect to submit the T2Resistance panel to the FDA during the first quarter of 2025. This one quarter delay is due to our decision to prioritize manufacturing products for current and new customers ahead of manufacturing the T2Resistance panel cartridges for internal R&D testing.

我們預計將於 2025 年第一季向 FDA 提交 T2Resistance 小組。之所以延遲一個季度，是因為我們決定優先為現有客戶和新客戶生產產品，然後再生產用於內部研發測試的 T2Resistance 面板墨盒。

The T2line panel is a direct from blood molecular diagnostic test designed for the early detection of [Berea and dori] the bacterium that causes Lyme disease in the United States. Lyme disease is the leading vector borne disease in America with an estimated 3.4 million tests performed each year.

T2line 面板是一種直接來自血液的分子診斷測試，旨在早期檢測在美國引起萊姆病的細菌 [Berea and dori]。萊姆病是美國最大的媒介傳播疾病，每年約有 340 萬人次接受檢測。

The current diagnostic product process is a two-tiered antibody test algorithm that relies on the presence of antibodies and can only be used accurately 4 weeks to 8 weeks after infection.

目前的診斷產品流程是雙層抗體檢測演算法，依賴抗體的存在，且只能在感染後4週至8週才能準確使用。

If left untreated, the bacteria may spread throughout the body and become much harder to eradicate and treat effectively. Although symptoms of Lyme disease are similar to [flu rli borri] infections can lead to chronic debilitating disease. To address this clinical unmet need we have developed an extremely sensitive diagnostic for the detection of early Lyme disease with an analytical sensitivity that is in line with our FDA cleared sepsis test.

如果不及時治療，細菌可能會擴散到全身，變得更難根除和有效治療。儘管萊姆病的症狀與流感病毒相似，但感染會導致慢性衰弱性疾病。為了滿足這一臨床未滿足的需求，我們開發了一種極其靈敏的診斷方法，用於檢測早期萊姆病，其分析靈敏度與我們經 FDA 批准的敗血症測試一致。

We have recently completed clinical studies required to launch the T2line panel as a laboratory developed test or LDT. We believe our test will detect Lyme disease within the 1st 30 days post infection compared to antibody test that can take 30 days to 60 days post infection.

我們最近完成了推出 T2line 面板作為實驗室開發測試或 LDT 所需的臨床研究。我們相信，我們的測試將在感染後 30 天內檢測出萊姆病，而抗體測試則需要感染後 30 天到 60 天。

The expanded T2Candida panel which will include the detection of can AUS is a direct from blood molecular diagnostic test designed to detect Candida species in just 3 hours to 5 hours without the need to wait days for a positive blood culture.

擴展的 T2Candida 面板將包括對 AUS 的檢測，它是一種直接從血液分子診斷測試中檢測念珠菌種類，旨在在短短 3 小時到 5 小時內檢測出來，而無需等待數天才能獲得陽性血液培養結果。

We believe the addition of can AIS detection will strengthen the value proposition of our T2candidate panel and lead to increased adoption.

我們相信，增加 AIS 偵測功能將增強我們的 T2candidate 面板的價值主張，並提高其採用率。

Canada AIS is a multi-drug-resistant fungal pathogen that has a mortality rate of up to 60% and is recognized as a serious global health threat by the CDC and the World Health Organization.

加拿大AIS是一種具有多重抗藥性的真菌病原體，死亡率高達60%，被美國疾病管制與預防中心和世界衛生組織認定為嚴重的全球健康威脅。

The CDC estimates the costs associated with US fungal diseases are as high as $48 billion annually and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the lifesaving benefits of early detection and proper treatment.

美國疾病管制與預防中心估計，美國真菌疾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繼續提高人們對早期發現和適當治療的救命益處的認識，以幫助減輕真菌疾病的負擔。

A 2022 journal of clinical microbiology study conducted at the Bambino Gesu Hospital in Rome Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with the T2Candida panel receives species identification results 121.8 hours faster compared to blood culture-based diagnostics.

2022 年，義大利羅馬 Bambino Gesu 醫院在《臨床微生物學》雜誌上進行了一項研究，發現疑似患有真菌血液感染的兒科患者使用 T2Candida 檢測組進行檢測後，與基於血液培養的診斷相比，可提前 121.8 小時獲得菌種鑑定結果。

The expanded T2bacteria panel to include a claim for pediatric testing. We expect to submit a form10-K premarket notification to the FDA to expand the use of our T2bacteria panel to include pediatric testing in 2025.

擴展的 T2 細菌面板包括兒科檢測要求。我們預計將向 FDA 提交一份 10-K 表格上市前通知，以擴大我們的 T2bacteria 面板的使用範圍，在 2025 年將兒科檢測納入其中。

With that, I'll now turn the call over to John Sprague to provide a detailed update on our first quarter. Financial results, John.

現在，我將把電話轉給約翰·斯普拉格 (John Sprague)，讓他提供有關我們第一季的詳細更新資訊。財務結果，約翰。

Thank you, John.

謝謝你，約翰。

Third quarter, 2024 revenues were $2 million from sepsis product sales a 34% increase from the prior year. Period. International instrument sales increased 78% and sepsis test sales increased 34% compared to the prior year period.

2024 年第三季度，敗血症產品銷售收入為 200 萬美元，比前一年成長 34%。時期。與去年同期相比，國際儀器銷售額成長了 78%，敗血症測試銷售額成長了 34%。

Second quarter, 2024 cost of product revenues were $4.1 million a 4% increase compared to the prior year period driven by increased international instrument and sepsis test. Sales research and development expenses were $2.7 million comparable to the prior year period.

2024 年第二季產品收入成本為 410 萬美元，較去年同期成長 4%，這得益於國際儀器和敗血症測試的增加。銷售研發費用為 270 萬美元，與去年同期持平。

Selling general administrative expenses were $5.4 million a 10% decrease compared to the prior year period driven by decreased headcount offset by increased legal expenses.

銷售一般管理費用為 540 萬美元，與去年同期相比下降 10%，原因是員工人數減少，但法律費用增加。

The third quarter, 2024 net loss was $10.1 million $0.57 per share compared to the prior year. Third quarter, net loss of $15.4 million $3.45 per share.

2024 年第三季淨虧損為 1,010 萬美元，每股虧損 0.57 美元，與去年同期相比。第三季淨虧損1,540萬美元，每股虧損3.45美元。

Cash and cash equivalents were $2.1 million as of September 30, 2024, we raised $4.3 million in net proceeds with our ATM during the quarter and $3.2 million since September 30, 2024.

截至 2024 年 9 月 30 日，現金和現金等價物為 210 萬美元，我們在本季度透過 ATM 籌集了 430 萬美元的淨收益，自 2024 年 9 月 30 日以來籌集了 320 萬美元。

As we announced last week, the company received a notice from NASDAQ on November 7, 2024, indicating that the company's market value had been trading below listing requirements. We have appealed the notice and expect to put forth a plan of compliance to NASDAQ.

正如我們上周宣布的那樣，該公司於2024年11月7日收到納斯達克的通知，表明該公司的市值一直低於上市要求。我們已對該通知提出上訴，並希望向納斯達克提出合規計畫。

We expect fourth quarter 2024 total sepsis and product revenues of $2.5 million to $3.5 million. This target does not include potential sales of T2Biothreat or T2Lyme tests. Thank you and back to John Sperzel for closing remarks.

我們預計 2024 年第四季敗血症和產品總收入為 250 萬美元至 350 萬美元。該目標不包括 T2Biothreat 或 T2Lyme 測試的潛在銷售。謝謝大家，最後請 John Sperzel 致閉幕詞。

Thank you, John.

謝謝你，約翰。

We're very encouraged by our progress made in the third quarter of 2024 compared to the prior year period including total revenue growth of 34%. Sepsis test panel revenue growth of 34% US T2Bacteria panel growth of 173% and T2DX instrument growth of 78% internationally.

與去年同期相比，我們對 2024 年第三季的進展感到非常鼓舞，包括總收入成長了 34%。敗血症檢測面板收入成長 34%，美國 T2Bacteria 面板成長 173%，T2DX 儀器在國際上成長 78%。

Moving forward, we're excited by the potential to accelerate the growth of our Sepsis business in the United States through the exclusive commercial Agreement with Cardinal Health and the co-marketing Agreement with Precision.

展望未來，我們很高興能夠透過與 Cardinal Health 簽訂的獨家商業協議以及與 Precision 簽訂的聯合行銷協議來加速我們在美國敗血症業務的成長。

Our new product pipeline is rich with potential catalysts that have already received FDA breakthrough device designation including the T2Resistance panel which we plan to submit for FDA for form 10-K clearance during the first quarter of 2025. The T2line panel, the expanded T2Candida panel to include the detection of Canada AIS and the expanded T2bacteria panel to include a claim for pediatric testing.

我們的新產品線擁有豐富的潛在催化劑，這些催化劑已經獲得 FDA 突破性設備稱號，其中包括 T2Resistance 面板，我們計劃在 2025 年第一季向 FDA 提交 10-K 表格審批。T2line 面板、擴展的 T2Candida 面板（包括加拿大 AIS 的檢測）和擴展的 T2bacteria 面板（包括兒科檢測的索賠）。

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

就這樣。我想將電話轉回給接線員，以便開通問答熱線。

(Operator Instructions)

（操作員指示）

Eduardo Martinez, H.C. Wainwright & Co., LLC

愛德華多·馬丁內斯，H.C. Wainwright & Co., LLC

Hi, thank you for taking my questions. Just to just have a few questions regarding the partnership with Cardinal House has Card House already started marketing T2Lyme systems products. And what do you expect the effects to show in the false quarter financials.

你好，謝謝你回答我的問題。我只是想問幾個關於與 Cardinal House 合作的問題，Card House 是否已經開始行銷 T2Lyme 系統產品。您預計虛假季度財務數據會呈現什麼樣的影響？

And a final question is in the third quarter out of the 11 instruments play executed, you have one in the US. Do you expect the partnership with cutting a house to shift the instrument executed to be more in the US than internationally. Thank you.

最後一個問題是，在第三季執行的 11 種樂器中，有一種是在美國演奏的。您是否希望與切割屋的合作能夠將執行的工具轉移到美國而不是國際？謝謝。

Yes, thanks for the question. So, let me just take the second two parts of that question. One, we absolutely expect the relationship with Cardinal to increase our instrument and consumable sales in the United States. We have begun the marketing with Cardinal Health, and I just want to add a little bit more color around maybe the why behind a partnership with Cardinal which we're certainly excited about as there are over 6,000 hospitals in the US. We believe every one of them should have a T2DX instrument and be using our test but as a small company with limited resources, it's pretty difficult for us to reach them alone.

是的，謝謝你的提問。那麼，我只想回答這個問題的後兩個部分。首先，我們絕對希望與 Cardinal 的合作能增加我們在美國的儀器和消耗品銷售。我們已經開始與 Cardinal Health 合作進行行銷，我只是想稍微解釋一下與 Cardinal 合作的原因，我們對此感到非常興奮，因為美國有超過 6,000 家醫院。我們相信他們每個人都應該擁有一台 T2DX 儀器並使用我們的測試，但作為一家資源有限的小公司，我們很難獨自聯繫他們。

And so, to address that, we have been searching for a partner with a number of characteristics that we found in cardinal, one would be a partner with a significant presence in US hospitals, a large commercial organization and a strong balance sheet because we think that translates into credibility from a customer perspective.

因此，為了解決這個問題，我們一直在尋找一個具有 Cardinal 所具備的一些特徵的合作夥伴，一個在美國醫院中佔有重要地位的合作夥伴，一個大型商業組織和強大的資產負債表，因為我們認為從客戶的角度來看，這意味著可信度。

As I mentioned earlier, Cardinal is one of the largest health care companies in the United States. They have over $2 billion in annual sales. They sell to over 90% of us hospitals and they have broad GPO contracts. So, they are a trusted partner of us hospitals.

正如我之前提到的，Cardinal 是美國最大的醫療保健公司之一。他們的年銷售額超過20億美元。他們向美國 90% 以上的醫院銷售產品，並且擁有廣泛的 GPO 合約。所以，他們是我們醫院值得信賴的合作夥伴。

Second, we were looking for a partner with a strong presence in US hospital, microbiology labs as we think that translates into an important custom relationships which we've already seen with Cardinal throughout the training and early stages of marketing together, for example: within the first week of training, the Cardinal folks, Cardinal has already set up a meeting with a 20 plus hospital system. We never would have been able to get in front of that system on our own.

其次，我們正在尋找一個在美國醫院、微生物實驗室中具有強大影響力的合作夥伴，因為我們認為這將轉化為重要的客戶關係，我們已經在整個培訓和早期營銷階段與 Cardinal 看到了這種關係，例如：在培訓的第一周內，Cardinal 的員工，Cardinal 已經與 20 多家醫院系統安排了會議。我們永遠不可能獨自領先於該系統。

And then lastly, we were looking for a partner that wanted our products within their portfolio. We know that our products are highly differentiated, but we wanted a partner that was sort of hungry to have them within their portfolio. And we saw that in Cardinal and they certainly understand that exclusive rights to our products provides differentiation for them vis a vis their competitors. So, sort of all those three reasons are why we chose Cardinal. We're certainly excited about it. We think it's going to have a significant impact in 2025, and it may impact 2024 we have about six weeks left in the quarter.

最後，我們正在尋找一個希望將我們的產品納入其產品組合的合作夥伴。我們知道我們的產品具有高度差異化，但我們希望合作夥伴能夠渴望將這些產品納入他們的產品組合中。我們在 Cardinal 身上看到了這一點，他們當然明白，我們產品的獨家權利為他們提供了與競爭對手的差異化優勢。所以，以上三個原因就是我們選擇 Cardinal 的原因。我們對此確實感到興奮。我們認為它將在 2025 年產生重大影響，並可能影響 2024 年，本季還剩下大約六週的時間。

Got it. And the question regarding the LDT is that something we should expect to see having a contribution to the top line revenue in the first half of 2025.

知道了。關於 LDT 的問題是，我們應該預期它在 2025 年上半年對營業收入做出貢獻。

That's our plan. The line season typically starting earlier and earlier each year. Historically, it's kind of started around the April, May time frame. So, I think sometime in the latter half of second quarter is when we're targeting to launch that as an LDT.

這就是我們的計劃。線路季節通常每年開始得越來越早。從歷史上看，它大約在四月、五月左右開始。因此，我認為我們計劃在第二季後半段的某個時候將其作為 LDT 推出。

Got it. Thank you.

知道了。謝謝。

Thank you.

謝謝。

We have reached the end of our question-and-answer window and at this time, I would like to see if management has any closing remarks.

我們的問答環節已經結束，現在我想看看管理層是否有任何結束語。

I'd like to thank you all for participating in our Q3 earnings call and look forward to updating on our next call.

我想感謝大家參加我們的第三季財報電話會議，並期待在下次電話會議上更新情況。

Okay. This does conclude today's conference call and you may disconnect your lines at this time. Thank you for your participation.

好的。今天的電話會議到此結束，您可以斷開線路了。感謝您的參與。