Co-Diagnostics Inc (CODX) 2024 Q2 法說會逐字稿

Good day, and welcome to the Co-Diagnostics second quarter 2024 earnings conference call. (Operator Instructions) Please note that this event is being recorded.

美好的一天，歡迎參加 Co-Diagnostics 2024 年第二季財報電話會議。（操作員說明）請注意，該事件正在被記錄。

I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. Please go ahead.

我現在想將會議交給投資者關係主管安德魯·本森 (Andrew Benson)。請繼續。

Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer.

大家下午好。感謝大家參加今天的電話會議。今天，聯合診斷公司 (Co-Diagnostics) 的首席執行官德懷特·伊根 (Dwight Egan) 接聽了電話。和財務長布萊恩·布朗。

Earlier today, Co-Diagnostics released financial results from the second quarter ended June 30, 2024. A copy of the press release is available on the company's website. We will begin the call with management's prepared remarks and then open up the call to analyst Q&A.

今天早些時候，Co-Diagnostics 發布了截至 2024 年 6 月 30 日的第二季財務業績。該新聞稿的副本可在該公司網站上取得。我們將以管理層準備好的演講開始電話會議，然後開始與分析師進行問答。

Before we begin, we would like to inform the listeners that certain statements made by Co-Diagnostics during this call that are not historical facts are forward-looking statements. This includes statements concerning the company's forthcoming Co-Dx PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use, is currently being reviewed by the US FDA and is not currently for sale.

在開始之前，我們想告知聽眾，聯合診斷公司在本次電話會議中做出的某些非歷史事實的陳述屬於前瞻性陳述。其中包括有關該公司即將推出的 Co-Dx PCR 測試平台的聲明，該平台需要監管部門的批准和行銷授權才能用於診斷，目前正在接受美國 FDA 的審查，目前尚未出售。

Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in Co-Diagnostics filings with the SEC. Co-Diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events.

實際結果和結果可能與任何聲明中明示或暗示的內容有重大差異。可能導致實際結果與這些前瞻性陳述中的結果有重大差異的重要因素在向 SEC 提交的聯合診斷文件中有詳細說明。Co-Diagnostics 不承擔任何義務，並明確拒絕更新任何前瞻性陳述以反映本次電話會議後發生的事件或情況或反映意外事件的發生。

In addition, the company may discuss certain non-GAAP financial measures during today's call. These non-GAAP financial measures should not be considered a replacement for and should be read together with GAAP results. We refer you to the company's earnings release issued shortly before this call, which contains reconciliations to the non-GAAP financial measures presented to their most comparable GAAP results.

此外，該公司可能會在今天的電話會議上討論某些非公認會計準則財務措施。這些非公認會計原則財務指標不應被視為替代公認會計原則結果，而應與公認會計原則結果一起閱讀。我們建議您參閱本次電話會議前不久發布的公司收益報告，其中包含對非公認會計原則財務指標與其最具可比性的公認會計原則結果的調節。

At this time, I would like to turn the call over to Co-Diagnostics Chief Executive Officer, Dwight Egan. Dwight?

此時，我想將電話轉給聯合診斷執行長德懷特伊根 (Dwight Egan)。德懷特？

Thank you, Andrew, and good afternoon, everyone. Thank you all for joining Co-Diagnostics Second Quarter 2024 Earnings Call. I want to start by thanking everyone at Co-Diagnostics for all their hard work, which has led to a successful first half of the year on multiple fronts.

謝謝你，安德魯，大家下午好。感謝大家參加 Co-Diagnostics 2024 年第二季財報電話會議。首先，我要感謝 Co-Diagnostics 的每個人的辛勤工作，他們使今年上半年在多個方面取得了成功。

Over the past several months, we have made significant progress towards bringing our low-cost, easy-to-use and disrupted point-of-care platform to patients around the world. In June, we submitted our first 510(k) application to the FDA for our Co-Dx PCR Pro and Co-Dx PCR COVID-19 test kit for over-the-counter use, a pivotal milestone for our platform as we approached a commercial launch.

在過去的幾個月裡，我們在向世界各地的患者提供低成本、易於使用和顛覆性的即時護理平台方面取得了重大進展。6 月，我們向FDA 提交了第一份510(k) 申請，申請用於非處方使用的Co-Dx PCR Pro 和Co-Dx PCR COVID-19 檢測試劑盒，這是我們平台的關鍵里程碑，因為我們接近商業啟動。

During the quarter, we also continued to make progress in the development of our tuberculosis, respiratory multiplex, HPV and strep tests and remain well positioned to advance our development processes throughout the rest of the year.

本季度，我們在結核病、呼吸道複合物、HPV 和鏈球菌檢測的開發方面繼續取得進展，並在今年剩餘時間繼續推進我們的開發進程。

We focused our commercial efforts on two trade shows where we showcased our Co-Dx PCR platform to market participants, demonstrating the impact our technology can have on the broader health ecosystem. I'm very excited by the progress that we have made so far and believe that we can remain in a strong position to execute our goals for the remainder of 2024.

我們將商業努力集中在兩個貿易展上，向市場參與者展示了我們的 Co-Dx PCR 平台，展示了我們的技術對更廣泛的健康生態系統的影響。我對我們迄今為止的進展感到非常興奮，並相信我們能夠保持強勢地位，在 2024 年剩餘時間內實現我們的目標。

As I mentioned, in the second quarter, we submitted a 510(k) application to the US FDA for our Co-Dx PCR platform for the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 test for over-the-counter or OTC use. We completed the submission through the FDA's electronic Submissions Template and Resource or eSTAR system, which is a comprehensive resource for medical device manufacturers that allowed us to standardize all information in preparation for our 510(k). Our team conducted extensive preparation, research and data to submit what we believe will become a gold standard PCR diagnostics platform for its intended use.

正如我所提到的，在第二季度，我們向美國 FDA 提交了 510(k) 申請，要求我們的 Co-Dx PCR 平台用於 Co-Dx PCR Pro 儀器和 Co-Dx PCR COVID-19 檢測。櫃檯或OTC使用。我們透過 FDA 的電子提交模板和資源或 eSTAR 系統完成了提交，該系統是醫療器械製造商的綜合資源，使我們能夠標準化所有信息，為 510(k) 做準備。我們的團隊進行了廣泛的準備、研究和數據提交，我們相信這將成為其預期用途的黃金標準 PCR 診斷平台。

Clearance by the FDA would allow our platform to be utilized in settings such as the home and workplaces. Medical devices cleared for use in OTC settings are automatically categorized as CLIA-waived. Such clearance by the FDA will allow for the PCR Pro instrument, software and COVID-19 test to be used by point of care or POC users, which we believe will help further expand the addressable market and value proposition of our platform. In the meantime, we remain in communication with the FDA on our existing 510(k) submission and look forward to providing you with more updates as they become available.

FDA 的許可將使我們的平台能夠在家庭和工作場所等環境中使用。獲准在 OTC 設定中使用的醫療設備會自動歸類為 CLIA 豁免的醫療設備。FDA 的此類許可將使 PCR Pro 儀器、軟體和 COVID-19 測試可供護理點或 POC 用戶使用，我們相信這將有助於進一步擴大我們平台的潛在市場和價值主張。同時，我們仍就現有的 510(k) 提交與 FDA 保持溝通，並期待為您提供更多更新。

Upon the full commercialization of our platform for OTC settings, we plan to make it available to consumers and businesses or offices where multiple tests could be run each day as well as for at-home use. For POC users, we plan to initially target high-volume care centers, including skilled nursing facilities, physicians offices, clinics and assisted living centers.

在我們的 OTC 設定平台全面商業化後，我們計劃將其提供給消費者、企業或辦公室，每天可以執行多項測試以及在家中使用。對於 POC 用戶，我們計劃首先瞄準大容量護理中心，包括熟練護理設施、醫生辦公室、診所和輔助生活中心。

We see a large opportunity for high utilization of the our device and associated COVID-19 test kits in skilled nursing facilities where there remains an ongoing requirement and need to perform COVID testing due to the vulnerable populations that reside in them.

我們看到在熟練的護理機構中高度利用我們的設備和相關的 COVID-19 測試套件的巨大機會，因為這些機構中居住著弱勢群體，因此仍然存在持續的需求並需要進行 COVID 測試。

Our regulatory strategy for this initial test on the Co-Dx PCR Pro instrument will be crucial commercial platform and paving the path for utilization of additional tests in our pipeline in the future. Shortly following our 510(k) submission and in preparation for commercial launch, we attended two highly attended trade shows to showcase our Co-Dx PCR platform, FIME and ADLM.

我們在 Co-Dx PCR Pro 儀器上進行的初步測試的監管策略將成為至關重要的商業平台，並為未來在我們的管道中使用其他測試鋪平道路。在我們提交 510(k) 並準備商業發布後不久，我們參加了兩個備受關注的貿易展，以展示我們的 Co-Dx PCR 平台 FIME 和 ADLM。

In June, we attended the Florida International Medical Expo, or FIME, one of the leading medical trade expos for medical device and product purchasers. We are enthused by the turnout at FIME with exhibitors from 116 countries and more than 15,000 professional attendees, which provided us with the opportunity to strengthen our relationships with key suppliers in the global medical device and equipment market, especially in Latin America.

六月，我們參加了佛羅裡達國際醫療博覽會 (FIME)，這是醫療器材和產品採購商的領先醫療貿易博覽會之一。我們對 FIME 的出席人數感到興奮，來自 116 個國家的參展商和超過 15,000 名專業觀眾，這為我們提供了加強與全球醫療器材和設備市場（尤其是拉丁美洲）主要供應商的關係的機會。

At the end of July, we attended the Association for Diagnostics and Laboratory Medicine, or ADLM 2024 meeting in Chicago, formerly known as AACC. The focus of our presentation at ADLM was centered around the utility of our platform, the development of our tests and the opportunity for PCR diagnostics to test for tuberculosis. Shows like FIME and ADLM play an important role in our initial pre-commercialization efforts and allow us to converse with key prospective customers and distributors on our accomplishments to date, along with our plans moving forward.

7 月底，我們參加了在芝加哥舉行的診斷和實驗醫學協會 (ADLM 2024)（以前稱為 AACC）會議。我們在 ADLM 上的演講重點是圍繞我們平台的實用性、我們測試的開發以及 PCR 診斷測試結核病的機會。FIME 和 ADLM 等展會在我們最初的商業化前工作中發揮了重要作用，使我們能夠與主要的潛在客戶和分銷商討論我們迄今為止的成就以及我們未來的計劃。

Turning to our test pipeline. We are very excited by the development progress we have made so far this year. We remain highly focused on our test for tuberculosis or TB, which remains the deadliest infectious disease in the world. Clinical samples from tuberculosis patients have already been run in TB test cups on the Co-Dx PCR Pro instrument, and we plan to initiate clinical trials on our TB test before the end of the year in South Africa as well as in India, one of our top priority markets for TB testing.

轉向我們的測試管道。我們對今年迄今所取得的開發進展感到非常興奮。我們仍然高度關注結核病或結核病的檢測，結核病仍然是世界上最致命的傳染病。結核病患者的臨床樣本已在 Co-Dx PCR Pro 儀器上的結核病檢測杯中進行了檢測，我們計劃於今年年底前在南非和印度（印度之一）啟動結核病檢測的臨床試驗。市場。

We are working very closely with NGOs and other organizations and groups to ensure that our TB test meets the needs of our target markets. These external groups are also helping to inform our TB commercial strategies surrounding markets of focus, market opportunity and total addressable market. We are iteratively refining our go-to-market strategy for TB, so that our team is best prepared to address the locations of highest need.

我們正在與非政府組織和其他組織和團體密切合作，以確保我們的結核病檢測滿足目標市場的需求。這些外部團體也幫助我們了解圍繞重點市場、市場機會和總目標市場的 TB 商業策略。我們正在反覆改善結核病的市場進入策略，以便我們的團隊做好充分準備，滿足最需要的地區的需求。

Following internal and external market research, we believe the global total addressable market for TB testing may reach over $3.6 billion within the next four years. This includes an estimated 17 million near point-of-care TB tests currently being performed in South and East Asia every year and 10 million in Africa.

經過內部和外部市場研究，我們相信未來四年內全球結核病檢測潛在市場總額可能超過 36 億美元。其中包括目前每年在南亞和東亞進行的約 1,700 萬次床邊結核病檢測，以及在非洲進行的 1,000 萬次檢測。

We are working closely with NGOs and other stakeholders in our target countries as we identify how much of the total global market will be serviceable by POC testing as infectious disease diagnostics continues its shift towards decentralization and how much we expect to be able to capture as our commercialization footprint grows.

我們正在與目標國家的非政府組織和其他利益相關者密切合作，確定隨著傳染病診斷繼續向分散化轉變，全球總市場有多少可以透過POC 測試來服務，以及我們期望能夠捕獲多少份額作為我們的目標。

We are also encouraged by the progress we have made so far this year on our multiplex upper respiratory and HPV tests. As we discussed on our most recent call, the upper respiratory multiplex test has the potential to provide low-cost and easily accessible diagnosis for some of the most pernicious respiratory infections in at-home and point-of-care settings, run on our new Co-Dx PCR Pro instrument, this test is strengthened by a low unit cost and could unlock significant clinical and economic efficiencies enabled by the ability to detect COVID, Flu A, Flu B and RSV infections all at once. We continue to expect clinical evaluations to commence during the upcoming North American flu season.

我們也對今年迄今在多重上呼吸道和 HPV 檢測方面取得的進展感到鼓舞。正如我們在最近的電話會議中討論的那樣，上呼吸道多重測試有潛力為家庭和護理點環境中的一些最有害的呼吸道感染提供低成本且易於獲得的診斷，在我們的新設備上運行Co- Dx PCR Pro 儀器，該測試因單位成本低而得到加強，並且可以透過同時檢測COVID、A 型流感、B 型流感和RSV 感染的能力來釋放顯著的臨床和經濟效率。我們繼續預計臨床評估將在即將到來的北美流感季節開始。

The development of this specific test has also driven even more innovations on the platform, including enhancements to the instrument and to the software, which we believe will provide local, national and international organizations the ability to monitor and react to disease outbreaks.

這項特定測試的發展也推動了該平台的更多創新，包括儀器和軟體的增強，我們相信這將為當地、國家和國際組織提供監測和應對疾病爆發的能力。

These continued iterated upgrades are the result of input from prospective markets and customers, which underscores our commitment to design and development process focused on producing results that directly address existing shortcomings in health care, all with the aim of producing diagnostics that could easily be adopted by users searching for better solutions.

這些持續迭代的升級是來自潛在市場和客戶的意見的結果，這強調了我們對設計和開發流程的承諾，重點是產生直接解決醫療保健中現有缺陷的結果，所有這些都是為了產生易於被廣泛採用的診斷方法。

And while we remain highly focused on taking the platform to market with the pipeline of tests we have already shared, ongoing R&D is also continually expanding the boundaries of this innovative new platform's capabilities, providing new opportunities for the future that we believe have the potential to dramatically increase its impact well beyond our original vision.

雖然我們仍然高度專注於透過我們已經分享的一系列測試將該平台推向市場，但正在進行的研發也在不斷擴大這個創新平台功能的邊界，為未來提供新的機會，我們相信這些機會有潛力大大提高其影響力，遠遠超越我們最初的願景。

Our team is committed to developing more than just respiratory infection diagnostics as we believe our device can also make other diagnostic processes such as STI testing more efficient. On HPV, Co-Diagnostics has continued to work closely with our Indian joint venture, Cosara Diagnostics, where research shows there exists a significant need for HPV testing and test accessibility.

我們的團隊致力於開發的不僅僅是呼吸道感染診斷，因為我們相信我們的設備還可以使其他診斷過程（例如性傳染感染測試）更有效率。在 HPV 方面，Co-Diagnostics 繼續與我們的印度合資企業 Cosara Diagnostics 密切合作，該公司的研究表明，對 HPV 檢測和檢測可及性有巨大需求。

Our HPV test efforts are supported by the Bill and Melinda Gates Foundation grant that we received last year, which speaks to the importance of the work that we continue to do. Additionally, while our strep A test is the most recent test to be added to our pipeline, we are excited by our development strategy and the opportunity to help diagnose patients in pediatric centers and clinics around the country.

我們的 HPV 檢測工作得到了去年獲得的比爾和梅琳達蓋茲基金會資助的支持，這說明了我們繼續進行的工作的重要性。此外，雖然我們的 A 型鏈球菌檢測是我們管道中最新添加的檢測，但我們對我們的發展策略以及幫助診斷全國兒科中心和診所患者的機會感到興奮。

Before closing, I would like to briefly discuss the progress of our vector control business. We are pleased that the Co-Dx vector control footprint continued to grow in the US this quarter with expansion into Nevada, the 15th US state we have reached with this technology.

在結束之前，我想簡單談談我們向量控制業務的進展。我們很高興看到 Co-Dx 向量控制足跡本季在美國繼續成長，並擴展到內華達州，這是我們使用該技術到達的美國第 15 個州。

Our vector control suite of product offerings includes Vector Smart PCR tests that can be utilized for mosquito-borne illness surveillance and which deliver same-day results of mosquito pool testing to more quickly mitigate transmission of disease to humans and animals.

我們的向量控制產品套件包括 Vector Smart PCR 測試，可用於蚊媒疾病監測，並提供當天的蚊池測試結果，以更快地減少疾病向人類和動物的傳播。

This comes at a time when nearly 200 people have been infected with dengue virus in New York and New Jersey according to the CDC and a public health emergency for the mosquito-borne illness has been declared in the US territory of Puerto Rico.

據美國疾病管制與預防中心 (CDC) 稱，紐約和新澤西州已有近 200 人感染登革熱病毒，美國領土波多黎各也已宣布針對這種蚊媒疾病進入公共衛生緊急狀態。

As mentioned on our prior call, while our Vector Smart testing products primarily include those for mosquito abatement, our flu A, B and COVID-19 or ABC Logix Smart test has shown capabilities to detect the H5N1 virus or Avian flu. Co-Diagnostics has initiated work to explore ways in which our company can be beneficial in H5N1 detection, which has included initial design work for a more specific Co-Primers H5N1 test. We look forward to the opportunity to develop an effective and efficient detection solution for the H5N1 virus should the need for the product to rise.

正如我們之前的電話中提到的，雖然我們的Vector Smart 測試產品主要包括滅蚊產品，但我們的甲型、乙型流感和COVID-19 或ABC Logix 智能測試已顯示出檢測H5N1 病毒或禽流感的能力。Co-Diagnostics 已開始探索使我們公司在 H5N1 檢測中受益的方法，其中包括更具體的 Co-Primer H5N1 測試的初步設計工作。如果產品需求增加，我們期待有機會開發有效且高效的 H5N1 病毒檢測解決方案。

To close, I would like to express my confidence in the value proposition that Co-Diagnostics will bring to the global molecular diagnostics market, especially at the point of care. We have strategically positioned ourselves to transform the way that providers test for infectious diseases.

最後，我想表達我對聯合診斷將為全球分子診斷市場帶來的價值主張的信心，特別是在護理方面。我們的策略定位是改變醫療服務提供者檢測傳染病的方式。

Our patented Co-Primers technology significantly reduces the number of false positives, leading to results that health care providers can trust and with enhanced multiplexing capabilities, which are then delivered to the Co-Dx mobile app in approximately 30 minutes through our platform's cloud-based HIPAA-compliant technology.

我們專利的Co-Primers 技術可顯著減少誤報數量，從而產生醫療保健提供者可以信賴的結果，並具有增強的多重功能，然後透過我們基於雲端的平台在大約30 分鐘內將結果傳送到Co-Dx 行動應用程式符合 HIPAA 的技術。

The size of our instrument, our in-house manufacturing and scale capabilities, efficient management of our balance sheet and the grant support we have received provides Co-Diagnostics with the ability to support a commercial launch that enables platform delivery to populations all around the world. We are excited by the potential that the Co-Dx PCR platform has to increase availability and accessibility of the highest quality of diagnostics and to improve the quality of global health care.

我們的儀器規模、我們的內部製造和規模化能力、資產負債表的高效管理以及我​​們收到的贈款支持，使Co-Diagnostics 能夠支持商業發布，從而使平台能夠交付給世界各地的人群。我們對 Co-Dx PCR 平台提高最高品質診斷的可用性和可及性以及提高全球醫療保健品質的潛力感到興奮。

I'm proud of our Co-Diagnostics team and the immense effort that they have dedicated to improving the quality of health care through best-in-class diagnostics. I look forward to providing you with more updates as we progress throughout the remainder of 2024.

我為我們的聯合診斷團隊以及他們為透過一流的診斷提高醫療保健品質而付出的巨大努力感到自豪。隨著 2024 年剩餘時間的進展，我期待為您提供更多更新資訊。

With that, I will now turn the call over to Brian to discuss our second quarter financial results.

現在，我將把電話轉給布萊恩，討論我們第二季的財務表現。

Thanks, Dwight, and thanks to everyone who joined today's call. For the second quarter of 2024, total revenue increased to $2.7 million as compared to $0.2 million in the prior year same period. Grant revenue in the second quarter of 2024 was $2.5 million and product revenue was $0.2 million. Gross profit for the quarter increased to $2.4 million compared to negative $0.3 million in the prior year comparable period.

謝謝德懷特，也感謝所有參加今天電話會議的人。2024 年第二季度，總營收增至 270 萬美元，去年同期為 20 萬美元。2024 年第二季的資助收入為 250 萬美元，產品收入為 20 萬美元。本季毛利增至 240 萬美元，去年同期為負 30 萬美元。

Total operating expenses for the quarter ended June 30, 2024, decreased to $10.1 million from $11.7 million in the second quarter of 2023. The decrease from the prior year is primarily due to higher expenses in 2023 related to stock-based compensation, bad debt and expenses related to clinical trials for the Co-Dx PCR platform. Research and development expenses in the second quarter were $5.6 million compared to $6.0 million in the comparable prior year period.

截至 2024 年 6 月 30 日的季度總營運費用從 2023 年第二季的 1,170 萬美元減少至 1,010 萬美元。較前一年減少的主要原因是 2023 年與股票薪酬、壞帳相關的費用以及與 Co-Dx PCR 平台臨床試驗相關的費用增加。第二季的研發費用為 560 萬美元，而去年同期的研發費用為 600 萬美元。

For the second quarter, income before taxes was a loss of $7.7 million as compared to a loss of $11.2 million reported in the prior year. Net loss for the second quarter of 2024 was $7.6 million or a loss of $0.25 per fully diluted share compared to a net loss of $8.9 million or a loss of $0.31 per fully diluted share in the prior year. Adjusted EBITDA was a loss of $5.9 million, compared to an adjusted EBITDA loss of $9.6 million in the prior year.

第二季稅前收入虧損 770 萬美元，而前一年報告的虧損為 1,120 萬美元。2024 年第二季的淨虧損為 760 萬美元，或完全稀釋每股虧損 0.25 美元，而前一年的淨虧損為 890 萬美元，或完全稀釋每股虧損 0.31 美元。調整後 EBITDA 虧損 590 萬美元，而前一年調整後 EBITDA 虧損 960 萬美元。

We ended the quarter with $44.9 million in cash, cash equivalents and marketable investment securities. We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for long-term growth. Co-Diagnostics remains focused on maintaining our cash position through appropriate and diligent management to position the company for success upon a future commercial launch of our platform.

本季結束時，我們擁有 4,490 萬美元的現金、現金等價物和有價投資證券。我們將繼續管理支出，以維持健康的資產負債表，為長期成長做好準備。Co-Diagnostics 仍然專注於透過適當和勤勉的管理來維持我們的現金狀況，以使公司在我們平台未來的商業推出時取得成功。

We believe that we are operating from a strong cash position, and we'll continue to focus on driving operational efficiencies. We remain excited about our 2024 plan and are very optimistic about our test pipeline and the Co-Dx PCR platform. I look forward to updating you on our next earnings call.

我們相信，我們的營運擁有強大的現金狀況，並且我們將繼續專注於提高營運效率。我們對 2024 年計畫仍然感到興奮，並對我們的測試管道和 Co-Dx PCR 平台非常樂觀。我期待在下次財報電話會議上向您通報最新情況。

With that, I will now turn the presentation back over to Dwight.

現在，我將把演示轉回給德懷特。

Thank you, Brian. Before opening for Q&A, I want to take this time to extend a thank you to our Co-Dx shareholders in addition to our employees and distributors, who work hard each and every day to progress our platform and the mission of Co-Diagnostics. We will now take questions from our analysts. Operator?

謝謝你，布萊恩。在開始問答之前，我想藉此機會向我們的 Co-Dx 股東以及我們的員工和經銷商表示感謝，他們每天都在努力工作，以推進我們的平台和 Co-Diagnostics 的使命。我們現在將回答分析師的問題。操作員？

(Operator Instructions).

（操作員說明）。

Jade Montgomery with H.C. Wainwright.

蒙哥馬利 (Jade Montgomery) 與 H.C.溫賴特。

I am on for Yi Chen at H.C. Wainwright. So my first question, I mean, I know you just admitted it, but have you heard back at all from the FDA yet on the 510(k), any feedback or?

我是 H.C. 的陳一溫賴特。所以我的第一個問題，我的意思是，我知道您剛剛承認了這一點，但是您是否收到 FDA 關於 510(k) 的回复，有任何反饋嗎？

Thank you for your question. We have regular contact with the FDA since we have submitted.

謝謝你的提問。自提交以來，我們與 FDA 保持定期聯繫。

Any particular guidance you'd share with us? Or do you know when potentially you could expect that passing clearance?

有什麼特別的指導可以與我們分享嗎？或者你知道什麼時候你可以期待通過許可嗎？

We really can't comment on regulatory decisions by the FDA. We're in regular contact with them. We are pleased with their response so far.

我們確實無法對 FDA 的監管決定發表評論。我們與他們保持定期聯繫。我們對他們迄今為止的回應感到滿意。

Okay. And just, I mean, outside of that has -- with those two trade shows, has there been any potential customers that have really indicated their strong interest to place purchase orders once you get that 510(k) or?

好的。我的意思是，除此之外 - 透過這兩個貿易展，是否有任何潛在客戶真正表示出一旦收到 510(k) 或 510(k) 就下採購訂單的強烈興趣？

We have attended a lot of shows. Last year, we attended about 30 different shows. So we're always talking to potential customers about the benefits, progress that we're making. Until we have clearance from the FDA, we're not permitted to sell the product. So we have a lot of constructive conversations about what we're doing in the state of our technology, and we're very enthused by the response that we received from the market.

我們參加了很多演出。去年，我們參加了大約 30 場不同的演出。因此，我們總是與潛在客戶談論我們正在取得的好處和進步。在獲得 FDA 許可之前，我們不得銷售該產品。因此，我們就我們在技術狀態下正在做的事情進行了很多建設性的對話，並且我們對從市場收到的反應感到非常興奮。

I mean, that potential market is both domestic and international or mostly domestic?

我的意思是，潛在市場是國內和國際還是主要是國內？

It's both domestic and international. During the last several years, we have sold our product in over 50 different countries around the world. So we have a lot of distributors across the world. So the interest in our product spans the globe.

既有國內的，也有國際的。在過去的幾年裡，我們的產品已銷往全球 50 多個國家。所以我們在世界各地有很多經銷商。因此，全球各地都對我們的產品感興趣。

All right. Thank you so much and that's all I had for today. This concludes our question-and-answer session and today's conference call. Thank you for attending today's presentation. You may now disconnect.

好的。非常感謝，這就是我今天的全部內容。我們的問答環節和今天的電話會議到此結束。感謝您參加今天的演講。您現在可以斷開連線。