Co-Diagnostics Inc (CODX) 2022 Q4 法說會逐字稿

Good afternoon and welcome to the Co-Diagnostics, Inc. Fourth Quarter and Full Year 2022 Earnings Results Conference Call. (Operator Instructions) Please note that this event is being recorded today.

下午好，歡迎來到 Co-Diagnostics, Inc. 2022 年第四季度和全年收益結果電話會議。 （操作員說明）請注意，今天正在記錄此事件。

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

我現在想將會議轉交給投資者關係主管 Andrew Benson。請繼續，先生。

Thank you. I am Andrew Benson, and joining me this afternoon are members of the Co-Diagnostics management team, including Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. We will begin the call with management's prepared remarks and then open up the call to questions from our analysts.

謝謝。我是 Andrew Benson，今天下午加入我的是 Co-Diagnostics 管理團隊的成員，包括首席執行官 Dwight Egan；首席財務官布賴恩·布朗 (Brian Brown)。我們將以管理層準備好的發言開始電話會議，然後開始電話會議，讓我們的分析師提問。

Before we begin, we would like to inform the listeners that certain statements made by Co-Diagnostics during the course of this call may constitute forward-looking statements. Any statement about company expectations, beliefs, plans, objectives, assumptions or future events or performance are forward-looking statements. For example, statements concerning 2023 financial and operational guidance, the development, regulatory clearance, commercialization and features of new products, plans and objectives of management and market trends are all forward-looking statements. This includes statements concerning the company's forthcoming Co-Dx PCR Home testing platform, which is subject to FDA review and is not yet available for sale.

在我們開始之前，我們想告知聽眾，Co-Diagnostics 在本次電話會議期間所做的某些陳述可能構成前瞻性陳述。任何關於公司預期、信念、計劃、目標、假設或未來事件或業績的陳述都是前瞻性陳述。例如，有關 2023 年財務和運營指導、新產品的開發、監管許可、商業化和特性、管理計劃和目標以及市場趨勢的陳述都是前瞻性陳述。這包括有關公司即將推出的 Co-Dx PCR Home 測試平台的聲明，該平台正在接受 FDA 審查，目前尚未上市銷售。

The company believes these statements are based on reasonable assumptions. However, these statements are not guarantees of performance and involve known and unknown risks and uncertainties that may cause the actual results to be materially different from any future results expressed or implied by such statements. 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.

公司認為這些陳述是基於合理的假設。但是，這些陳述不是業績保證，涉及已知和未知的風險和不確定性，可能導致實際結果與此類陳述明示或暗示的任何未來結果存在重大差異。可能導致實際結果與這些前瞻性陳述中的結果存在重大差異的重要因素在提交給美國證券交易委員會的 Co-Diagnostics 文件中有詳細說明。 Co-Diagnostics 不承擔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發生的義務，並明確否認任何義務。

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 out shortly before this call, which may contain reconciliations to the non-GAAP financial measures presented to their most comparable GAAP results.

此外，公司可能會在今天的電話會議上討論某些非 GAAP 財務指標。這些非 GAAP 財務指標不應被視為替代 GAAP 結果，應與 GAAP 結果一起閱讀。我們建議您參考公司在本次電話會議前不久發布的收益報告，其中可能包含對非 GAAP 財務指標與其最具可比性的 GAAP 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 Co-Diagnostics 首席執行官 Dwight Egan。德懷特？

Thank you, Andrew, and thank you all for joining us. On this call, we will provide an overview of our results for 2022, updates on key financial performance metrics and a discussion of progress against our strategy. Then we will take questions from our analysts.

謝謝你，安德魯，感謝大家加入我們。在這次電話會議上，我們將概述我們 2022 年的業績、關鍵財務績效指標的更新以及對我們戰略進展的討論。然後我們將接受分析師的提問。

Three years ago at this time when Co-Dx had just recently become the first U.S.-based company with a CE marking for a COVID-19 test and nationwide shutdowns have barely begun we couldn't even imagine the state, the world would be in the weeks, months and years that followed. Through it all, Co-Diagnostics never lost sight of our mission to prevent the spread of infectious disease by making high-quality PCR diagnostics successful to communities all around the world, leveraging our experience in state-of-the-art PCR technology to achieve these goals.

三年前的這個時候，Co-Dx 剛剛成為第一家在 COVID-19 測試中獲得 CE 標誌的美國公司，全國范圍內的停產才剛剛開始，我們甚至無法想像這個世界會處於什麼樣的狀態接下來的幾週、幾個月和幾年。自始至終，Co-Diagnostics 從未忘記我們的使命，即通過向世界各地的社區成功提供高質量的 PCR 診斷來預防傳染病的傳播，利用我們在最先進的 PCR 技術方面的經驗來實現這些目標。

Our proven record of accomplishments in the last 3 years was accompanied not only by increased visibility in the world of diagnostics and a vastly increased distributor and customer base, but also the resources and connections to manifest a key element of our vision since our founding 10 years ago this year, reduction of health care costs around the globe by democratizing infectious disease testing made possible thanks to a platform bringing the highest level of quality and diagnostics directly to the people and places who need it the most.

我們在過去 3 年取得的成就記錄不僅伴隨著診斷領域知名度的提高以及經銷商和客戶群的大幅增加，而且還帶來了資源和聯繫，以體現我們自成立 10 年來的願景的關鍵要素今年早些時候，由於一個平台將最高水平的質量和診斷直接帶給最需要的人和地方，因此通過民主化傳染病檢測降低了全球醫療保健成本。

This can be in a remote clinic in rural India where tuberculosis has been endemic for generations or a skilled nursing facility in Ohio, looking for a way to reduce costs and provide better care for its patients by confidently identifying potential fatal respiratory diseases before they can spread or on the kitchen counter of a family concerned about the health of a young child in the middle of the night. Empowering patients and physicians to make informed timely health care decisions, either at the point of care at home or thanks to test processed and high-throughput clinical laboratory settings is the foundation of our corporate tagline the power to know.

這可以是在印度農村的偏遠診所，那裡的肺結核已經流行了幾代人，也可以是在俄亥俄州的一家專業護理機構，他們正在尋找一種方法來降低成本，並通過在潛在致命的呼吸道疾病傳播之前自信地識別它們來為患者提供更好的護理或者半夜在一個關心小孩健康的家庭的廚房櫃檯上。使患者和醫生能夠及時做出明智的醫療保健決策，無論是在家中的護理點，還是由於測試處理和高通量臨床實驗室設置，都是我們公司標語“知情權”的基礎。

That's why we're pleased to recently announce our Co-Dx PCR platform at home and point-of-care platform has begun the clinical trials and analytical studies that are expected to support submissions to the United States FDA and other regulatory bodies along with its initial COVID-19 test. As has been shared previously, the company's real-time PCR platform has been developed for detection of infectious diseases in at-home and point-of-care settings. And multiplex panels are planned to follow after receipt of the platform's initial regulatory authorization by the FDA.

這就是為什麼我們最近很高興地宣布我們的家庭 Co-Dx PCR 平台和床旁平台已經開始臨床試驗和分析研究，預計將支持向美國 FDA 和其他監管機構提交的申請及其初始 COVID-19 測試。正如之前分享的那樣，該公司的實時 PCR 平台已開髮用於在家庭和護理點設置中檢測傳染病。在收到 FDA 對該平台的初始監管授權後，計劃進行多路復用面板。

We have already built manufacturing lines for the device and sample collection cups and continue to expand our capacity to build more lines to meet expected future demand for our platform.

我們已經為設備和样品收集杯建造了生產線，並繼續擴大我們的產能以建造更多生產線以滿足我們平台的預期未來需求。

It's true that this milestone is the culmination of a development process that spans 2 years of research and development but more than that, it has its genesis in our corporate mission and is only possible due to the expert skills of well over 100 dedicated scientists, engineers and support staff stretching back nearly a decade. It brings together the power of our patented battle-tested CoPrimer technology, coupled with other proprietary IP, setting a new standard for compact point-of-care testing that unlocks the multiplexing potential of real-time PCR.

誠然，這一里程碑是跨越 2 年研發過程的頂峰，但更重要的是，它起源於我們的企業使命，並且只有 100 多名敬業的科學家、工程師的專業技能才有可能實現和支持人員可以追溯到近十年前。它匯集了我們久經考驗的專利 CoPrimer 技術的強大功能，再加上其他專有 IP，為緊湊型床旁檢測設立了新標準，釋放了實時 PCR 的多重潛力。

With regards to the planned respiratory panel for influenza A/B, COVID and RSV, our research and planning indicates that multiplex test can overcome a major price and convenience hurdle, allowing patients to test for multiple diseases all at once and for a single affordable price.

關於針對 A/B 型流感、COVID 和 RSV 的計劃呼吸面板，我們的研究和規劃表明，多重測試可以克服主要的價格和便利性障礙，讓患者能夠以單一的可負擔價格同時測試多種疾病.

The innovative sample collection cup and sample processing design is also ideal for other multiplex testing panels, such as the company's expected sexually transmitted infections multiplex panel. The cloud-based real-time epidemiology data also provides opportunities for departments and ministries of health to quickly identify and track outbreaks at a scale that has never been possible before such a tool existed and to provide resources and information where they are needed before diseases spread among a community or region.

創新的樣本收集杯和样本處理設計也適用於其他多重檢測面板，例如公司預期的性傳播感染多重檢測面板。基於雲的實時流行病學數據還為衛生部門和部委提供了機會，可以快速識別和跟踪這種工具存在之前從未有過的規模的疫情，並在疾病傳播之前在需要的地方提供資源和信息在社區或地區之間。

To illustrate the advantages of introducing such a platform into a high-risk environment currently relying on technology that is now becoming outdated, imagine a typical 100-bed skilled nursing facility operating close to capacity, which provides only single-plex antigen test kits for residents and its 100 staff members on hand at any given time, which include nurses, food service, administrative and general support staff. This kind of facility is among the most vulnerable to respiratory diseases, especially COVID, flu and RSV. In this hypothetical but realistic scenario, one of the newly arrived elderly residents is visited by a family member who is unaware of the RSV he brought with him from his daughter's daycare and they stayed behind after he came in contact with several staff members and residents.

為了說明將這樣一個平台引入目前依賴於現在已經過時的技術的高風險環境的優勢，想像一個典型的 100 個床位的專業護理機構接近滿負荷運轉，它只為居民提供單重抗原檢測試劑盒以及隨時待命的 100 名工作人員，其中包括護士、餐飲服務人員、行政人員和一般支持人員。這種設施最容易感染呼吸道疾病，尤其是 COVID、流感和 RSV。在這個假設但現實的場景中，一位新來的老年居民的一位家人拜訪了他，他不知道他從女兒的日託所帶來的 RSV，在他與幾名工作人員和居民接觸後，他們留下了。

A few of the staff reported filling [EO] 48 hours later as well as a handful of residents, many of whom didn't even come in contact with the original visitor. It wasn't until 5 days after the initial visit when one of the patients was hospitalized and tested for RSV that the facility realized that they had an outbreak of RSV among the staff and residents. The latter of whom all fall into a high-risk category for all respiratory illnesses. Dozens more positive cases follow, including other visitors who arrived healthy but left as carriers to say nothing of the financial and quality of life costs that would be borne by the facility as a result of an RSV outbreak that they might have prevented.

一些工作人員和少數居民報告說 48 小時後填充了 [EO]，其中許多人甚至沒有與最初的訪客接觸過。直到初次就診 5 天后，其中一名患者住院並接受 RSV 檢測，該機構才意識到他們在工作人員和居民中爆發了 RSV。後者屬於所有呼吸道疾病的高危人群。隨後出現了數十例陽性病例，其中包括其他健康抵達但作為攜帶者離開的訪客，更不用說由於他們本可以預防的 RSV 爆發而由設施承擔的財務和生活質量成本。

Now imagine the same facility, but this time, visitors are given an option to utilize a multiplex Co-Dx PCR home upper respiratory panel upon their arrival. And within 30 minutes know with a high degree of accuracy. Whether they are bringing one or more of 4 potentially deadly diseases into the facility.

現在想像一下同一個設施，但這一次，訪客可以選擇在他們到達時使用多重 Co-Dx PCR 家用上呼吸道面板。並在 30 分鐘內高度準確地知道。他們是否將 4 種潛在致命疾病中的一種或多種帶入設施。

This test would be free of charge to the visitor in roughly the same price to the facility as a single-plex antigen COVID test. Within 30 minutes, the facility would know that every member of the staff who came in contact with the individual should be tested every day for the next week, and every patient should be tested, quarantined and closely monitored stopping an outbreak before it could happen.

該測試將免費提供給訪客，費用與單重抗原 COVID 測試的價格大致相同。在 30 分鐘內，該機構就會知道，在接下來的一周裡，每一位與該人有過接觸的員工都應該每天接受檢測，每一位患者都應該接受檢測、隔離和密切監測，以防疫情爆發。

Let's say the visitor elects not to take advantage of the testing opportunity, but the facility has a policy that any staff member experiencing any symptoms is required to take the Co-Dx gold standard multiplex PCR test on their arrival to work unable to come into contact with any other staff or a patient until they received a negative result. 2 days later, a staff member test positive for RSV and the entire facility is immediately tested cutting the time detection from 5 days to 2 and hospitalizations to 0. The state health department is immediately notified of an outbreak of RSV in the area and informs the public who take extra precautions when sending their children to school. The outbreak is controlled, the well-being of the patients has improved. The facility's liability is dramatically reduced and tens of thousands of dollars are saved.

假設訪客選擇不利用檢測機會，但該設施有一項政策，要求任何出現任何症狀的工作人員在到達無法接觸的工作地點時進行 Co-Dx 黃金標準多重 PCR 檢測與任何其他工作人員或患者一起，直到他們收到陰性結果。 2 天后，一名工作人員的 RSV 檢測呈陽性，整個設施立即接受檢測，將檢測時間從 5 天縮短為 2 天，將住院時間縮短為 0。送孩子上學時採取額外預防措施的公眾。疫情得到控制，患者的健康得到改善。該設施的責任大大減少，節省了數万美元。

Perhaps most importantly, the patients and their caregivers experienced the peace of mind that comes with the power to know.

也許最重要的是，患者和他們的護理人員體驗到了知識帶來的內心平靜。

Similar scenarios can exist in other settings, but I hope this helps to illustrate the empowering effects that prompt accurate diagnosis can have on the quality of life of individuals and consumers.

類似的場景可能存在於其他環境中，但我希望這有助於說明提示準確診斷對個人和消費者的生活質量可能產生的賦權效應。

As an update on our clinical evaluations, all institutional review board or IRB approvals are in place for 5 locations and patient sampling has begun. Our current development time line projects that we expect to begin evaluations for our respiratory multiplex in time for the next flu and RSV season sometime in late 2023. These studies will continue uninterrupted to collect the data necessary to prepare for respective EUA or 510(k) FDA submissions for both of these, as we likewise expect to do for our other planned tests.

作為我們臨床評估的更新，所有機構審查委員會或 IRB 批准都已在 5 個地點到位，並且患者採樣已經開始。我們目前的開發時間表項目預計我們將在 2023 年末的某個時候及時開始對我們的呼吸系統多路復用進行評估，以應對下一個流感和 RSV 季節。這些研究將不間斷地繼續收集必要的數據，為相應的 EUA 或 510(k) 做準備FDA 提交了這兩項，正如我們同樣希望為我們的其他計劃測試所做的那樣。

Throughout the course of 2022, we continue to make progress on the optimization of the new Co-Dx PCR Home platform and defining its total addressable market launch along with development of our other business sectors and our in-demand PCR products.

在 2022 年的整個過程中，我們將繼續在優化新的 Co-Dx PCR Home 平台和定義其總體可尋址市場啟動以及我們其他業務部門和我們按需 PCR 產品的發展方面取得進展。

We believe the general trends seen in COVID-19 testing by the legacy centralized laboratory model reflects an appetite among consumers for COVID testing that is more affordable and as convenient as possible.

我們認為，傳統集中式實驗室模型在 COVID-19 測試中看到的總體趨勢反映了消費者對更實惠、盡可能方便的 COVID 測試的興趣。

Two key elements that have driven the innovation in our new platform. The secure cloud-based data system where analysis takes place also allows patients to send test results to their physician or other authorized parties as directed by the end user. And in the case of point-of-care locations directly to regulatory authorities as required by law.

推動我們新平台創新的兩個關鍵因素。進行分析的基於雲的安全數據系統還允許患者按照最終用戶的指示將測試結果發送給他們的醫生或其他授權方。並且在醫療點位置的情況下，根據法律要求直接向監管機構報告。

Interesting to note is the apparent divide between the perception that the danger of COVID is a thing of the past and the reality of the situation, which is that in the United States, we have reached an uncomfortable plateau of hundreds of deaths per day.

有趣的是，認為 COVID 的危險已成為過去的看法與現實情況之間存在明顯的分歧，即在美國，我們已經達到每天數百人死亡的令人不安的高原。

While the multiplexing value of the new platform is clear, we believe it is important to remember that the market for COVID testing will always exist, providing it can be available, affordable and convenient, 3 hallmarks of the Co-Dx PCR Home platform.

雖然新平台的多重價值是顯而易見的，但我們認為重要的是要記住，COVID 檢測市場將永遠存在，前提是它可用、負擔得起且方便，這是 Co-Dx PCR Home 平台的 3 個標誌。

A diagnostics company would ignore this and the market for COVID testing at their peril, doing themselves and their customers a disservice. We look forward to bringing our initial COVID test on the platform to market with the even more valuable multiplex panel to follow.

一家診斷公司會忽視這一點和 COVID 測試市場，這會給他們自己和他們的客戶帶來傷害。我們期待著將我們在平台上的初始 COVID 測試推向市場，隨後推出更有價值的多重面板。

We have continued to exercise financial intelligence and wide spending practices evident from our $81.3 million of cash and liquid reserves as we look toward to the company's future, which extends far beyond COVID. This total addressable market of high throughput locations for initial installations (technical difficulty).

在我們展望公司的未來時，我們繼續運用財務智慧和廣泛的支出實踐，這從我們 8130 萬美元的現金和流動儲備中可以看出，這遠遠超出了 COVID。初始安裝的高吞吐量位置的總可尋址市場（技術難度）。

Pardon me, ladies and gentlemen, it appears we have lost connection to our speaker line. Please stand by while we reconnect. Thank you very much for your patience. Ladies and gentlemen, this is the operator. We have reconnected the speakers, and we will continue. Please proceed with the call.

對不起，女士們先生們，我們的揚聲器線路好像斷線了。我們重新連接時請稍候。非常感謝您的耐心等待。女士們，先生們，我是接線員。我們已重新連接揚聲器，我們將繼續。請繼續通話。

I want to emphasize that our new platform has been designed and engineered to be versatile and durable with long-term disruptive potential as a diagnostic medical device, taking advantage of a worldwide shift to at-home point-of-care testing for a wide array of pathogens. We believe this shift along with the reduction or elimination in COVID testing mandates are largely responsible for our overall revenue decrease in 2022. But it is the versatility beyond COVID that we believe holds the greatest potential and that has attracted much attention to our new platform.

我想強調的是，我們的新平台的設計和製造具有多功能性和耐用性，作為一種診斷醫療設備具有長期的顛覆性潛力，利用全球範圍內向廣泛的家庭即時檢測轉變的優勢病原體。我們認為，這種轉變以及 COVID 測試任務的減少或取消是導致我們 2022 年整體收入下降的主要原因。但我們認為，超越 COVID 的多功能性具有最大的潛力，並引起了人們對我們新平台的廣泛關注。

Among the opportunities that we have already identified have been collaborations with international nongovernmental organizations, or NGOs, and nonprofits, such as FIND the global alliance for diagnostics. Our current project agreement with FIND is exploratory in nature, not remunerative, but FIND and other NGOs interest in the new platform extends to other endemic diseases such as tuberculosis, which took the lives of a staggering 1.6 million people in 2021 alone. This is even more shocking when you realize that despite all advances made in health care year-over-year, lately, these numbers are climbing. This has created an urgency among NGOs to slow the spread of the disease through increased access to gold standard real-time diagnostics exactly in line with our mission and our new platform.

我們已經確定的機會包括與國際非政府組織或非政府組織和非營利組織的合作，例如 FIND 全球診斷聯盟。我們目前與 FIND 的項目協議本質上是探索性的，不是有償的，但 FIND 和其他非政府組織對新平台的興趣擴展到結核病等其他地方病，僅在 2021 年一年，肺結核就奪走了 160 萬人的生命。當你意識到儘管醫療保健逐年取得進步，但最近這些數字還在攀升時，你會更加震驚。這使得非政府組織迫切需要通過增加對黃金標準實時診斷的訪問來減緩疾病的傳播，這完全符合我們的使命和我們的新平台。

Recently, Co-Dx has also been participating in the Apollo project being conducted by Seattle-based PATH, a global team of innovators working to accelerate health equity, so all people and communities can thrive. PATH advises and partners with public institutions, businesses, grassroots groups and investors to solve the world's most pressing healthcare challenges.

最近，Co-Dx 還參與了總部位於西雅圖的 PATH 正在進行的 Apollo 項目，這是一個全球創新團隊，致力於加速健康公平，讓所有人和社區都能茁壯成長。 PATH 為公共機構、企業、基層團體和投資者提供建議並與之合作，以解決世界上最緊迫的醫療保健挑戰。

The Apollo project is a molecular point-of-care platform, landscaping and benchmarking evaluation focused on advancing novel point-of-care molecular diagnostics for use in low-resource settings. This project aims to identify and assess molecular diagnostic technologies and to select the best-in-class that can have broader application and use for diseases of global concern.

Apollo 項目是一個分子護理點平台、景觀美化和基準評估，專注於推進用於資源匱乏環境的新型護理點分子診斷。該項目旨在確定和評估分子診斷技術，並選擇可對全球關注的疾病進行更廣泛應用和使用的同類最佳技術。

Co-Dx submitted the Co-Dx PCR Home platform for Phase I of Apollo and was selected from a large list of applicants to participate in Phase II of the evaluation, which is currently being conducted.

Co-Dx 提交了 Apollo 第一階段的 Co-Dx PCR Home 平台，並從大量申請人中選出參與目前正在進行的第二階段評估。

It is also proving to be helpful to have an established footprint in a country like India, which is a major area of focus for NGOs. Our Indian joint venture released 3 new IVD-cleared PCR products in 2022 for hepatitis B, hepatitis C and human papillomavirus and are in the process of completing the validation work on a tuberculosis test for drug-resistant strains of the bacteria opening up a large potential market for tuberculosis testing in India.

事實證明，在印度這樣的國家建立足跡也很有幫助，印度是非政府組織關注的主要領域。我們的印度合資企業在 2022 年發布了 3 種新的 IVD 清除的 PCR 產品，用於檢測乙型肝炎、丙型肝炎和人乳頭瘤病毒，並且正在完成針對細菌耐藥菌株的結核病測試的驗證工作，開闢了巨大的潛力印度結核病檢測市場。

We believe that the new platform's versatility that has garnered so much interest by NGOs is augmented by its durability. Our highly experienced and renowned team of developers, scientists and engineers tasked with bringing the Co-Dx PCR Home platform from concept to reality have remained fixed on the objective of building a durable platform technology that has the potential to address the needs in a variety of industries fueling future growth.

我們相信，新平台的耐用性增強了非政府組織如此感興趣的多功能性。我們經驗豐富且知名的開發人員、科學家和工程師團隊的任務是將 Co-Dx PCR Home 平台從概念變為現實，他們一直致力於構建一個有潛力滿足各種需求的耐用平台技術。推動未來增長的行業。

To that end, we have continued to optimize and refine the platform and all of its myriad components, including the user experience. We believe the additional time spent preparing the platform for clinical evaluations has been worth it as we seek to unveil a device that is considerably more robust than was initially conceived.

為此，我們繼續優化和改進平台及其所有組件，包括用戶體驗。我們相信，為臨床評估準備平台所花費的額外時間是值得的，因為我們正在尋求推出一種比最初設想的更強大的設備。

As [Morris] shared about the improvements and capabilities of this forthcoming product, we are confident that the price and specification advantages of our platform's value proposition against competitive products will create an opportunity for market leadership in this area.

正如 [Morris] 分享的關於這款即將推出的產品的改進和功能，我們相信我們平台的價值主張相對於競爭產品的價格和規格優勢將為該領域的市場領導地位創造機會。

Our current time line to product launch is as follows: clinical trials for the new platform to support our FDA EUA submission are ongoing. Because the valuations are dependent on identifying enrolling a particular number of both symptomatic and asymptomatic COVID-19 positive and negative patients at testing sites, the company will not be providing projected time lines for completion at this time. We are concurrently performing additional studies on the platform, including testing for tuberculosis and P. gingivalis for the dental market. Before beginning clinical trials, we also concluded another usability study for our initial COVID-19 test that showed strong results with no major challenges.

我們目前的產品發佈時間表如下：支持我們提交 FDA EUA 的新平台的臨床試驗正在進行中。由於估值取決於確定在測試地點招募特定數量的有症狀和無症狀的 COVID-19陽性和陰性患者，因此該公司目前不會提供預計的完成時間表。我們同時在該平台上進行其他研究，包括針對牙科市場的結核病和牙齦卟啉單胞菌測試。在開始臨床試驗之前，我們還完成了另一項針對我們最初的 COVID-19 測試的可用性研究，該研究顯示出很好的結果，沒有重大挑戰。

Our commercialization strategy is being guided by ongoing analysis provided by a respected field marketing research firm that has not only helped us to focus in on what we believe will be the most accessible high-throughput locations for our initial launch, but also provided invaluable feedback for optimization of the device itself on everything from the price to the packaging as the company better understands the size, scope and needs of the platform's total addressable market.

我們的商業化戰略以一家受人尊敬的實地營銷研究公司提供的持續分析為指導，這不僅幫助我們專注於我們認為最容易進入的高通量地點，而且還為我們的首次發布提供了寶貴的反饋隨著公司更好地了解平台的總體目標市場的規模、範圍和需求，從價格到包裝等各個方面對設備本身進行優化。

Some of the optimization work performed in 2022 includes enhanced TTR or time to result. Increased multiplexing capabilities and greater product stabilization, which results in longer shelf life for the test cartridges.

2022 年執行的一些優化工作包括增強的 TTR 或結果時間。增強的多路復用能力和更高的產品穩定性，從而延長了測試盒的保質期。

One of the most important innovations was the ability to test and go where an end user does not need to maintain proximity to the device or return to it following the run time and instead received their result on their smartphone from the cloud on the fly. In addition, end users can choose their own testing preference for the platform's initial COVID test by using either a swab or saliva.

最重要的創新之一是能夠進行測試並到達最終用戶不需要保持靠近設備或在運行時間後返回設備的地方，而是可以在智能手機上即時從雲端接收結果。此外，最終用戶可以使用拭子或唾液為平台的初始 COVID 測試選擇自己的測試偏好。

We intend to explore the relevant reimbursement codes already available for similar but nonreal-time PCR products on the market to work actively with health insurance companies on getting coverage for tests on the platform and to advocate for their FSA/HSA eligibility.

我們打算探索市場上已有的類似但非實時 PCR 產品的相關報銷代碼，以積極與健康保險公司合作，為平台上的測試提供保險，並宣傳他們的 FSA/HSA 資格。

The device has been designed to incorporate specialized optics and other innovative features to accommodate multiplex assays as we expand its future suite of products to include additional respiratory, STI and other infectious diseases utilizing our CoPrimer technology.

該設備的設計結合了專門的光學器件和其他創新功能，以適應多重檢測，因為我們將利用我們的 CoPrimer 技術擴展其未來的產品套件，以包括更多的呼吸道、性傳播感染和其他傳染病。

This patented molecule has unique properties associated with facilitating multiplex PCR and we intend to bring the full power and capabilities of our patented technology to our new Co-Dx PCR platform. And of course, our CoPrimer technology is more than just a unique innovative molecule. It is a platform technology with wide-ranging applications.

這種專利分子具有與促進多重 PCR 相關的獨特特性，我們打算將我們專利技術的全部力量和能力帶到我們新的 Co-Dx PCR 平台。當然，我們的 CoPrimer 技術不僅僅是一種獨特的創新分子。它是一種應用廣泛的平台技術。

In addition to other products we have discussed in previous public statements such as our ongoing development of a multiplex STI panel to detect and differentiate between 4 prevalent causes of sexually transmitted infections for both the new platform and our centralized lab business channel, the company rolled out 2 products for Mpox last year in response to an urgent health concern generated by that virus and continues to work on its upper respiratory panel multiplex for centralized labs as well.

除了我們在之前的公開聲明中討論過的其他產品，例如我們正在進行的多重 STI 面板開發，以檢測和區分新平台和我們的集中實驗室業務渠道的 4 種常見性傳播感染原因，該公司還推出了去年為 Mpox 開發了 2 種產品，以應對該病毒引起的緊迫健康問題，並繼續致力於集中實驗室的上呼吸道多路檢測。

We continued throughout the year to reinforce and increase our visibility among the centralized laboratory business channel that we have served across our growing distribution network of more than 50 countries following our strategy of maintaining a noticeable presence at conferences and trade shows. This high-throughput laboratory market is responsible for driving most of our sales, providing the cash flow for our R&D efforts and plans for future growth as we continue to grow the product pipeline for this business channel.

全年，我們繼續加強和提高我們在我們在 50 多個國家/地區不斷擴大的分銷網絡中所服務的集中實驗室業務渠道中的知名度，遵循我們在會議和貿易展覽中保持引人注目的存在的戰略。這個高通量實驗室市場負責推動我們的大部分銷售，為我們的研發工作和未來增長計劃提供現金流，因為我們繼續為這個業務渠道增加產品管道。

Our commitment to this channel was reinforced in 2022 by our expanded OEM agreement with Bio Molecular Systems for the Co-Dx Box magnetic induction PCR cycler to encompass 193 countries worldwide.

2022 年，我們與 Bio Molecular Systems 就 Co-Dx Box 磁感應 PCR 循環儀的 OEM 協議擴大到全球 193 個國家/地區，從而加強了我們對該渠道的承諾。

In previous calls, we have mentioned other PCR tools being developed for several pathogens of significance in dentistry, mental health and liquid biopsy for detection of cancer-associated mutations present in human blood. While it remains prudent for the company to remain focused on the opportunities within the infectious disease market, performance evaluations remain ongoing in conjunction with these initiatives.

在之前的電話會議中，我們提到了針對牙科、心理健康和液體活檢中幾種具有重要意義的病原體開發的其他 PCR 工具，用於檢測人體血液中存在的癌症相關突變。雖然公司繼續關注傳染病市場的機會仍然是謹慎的，但績效評估仍在與這些舉措一起進行。

Our work with Bayer Crop Services and LGC likewise continues within our agricultural vertical and the company's mosquito abatement business saw significant growth in 2022 in terms of laboratory installations and continued purchases from our existing customer base.

我們與拜耳作物服務公司和 LGC 的合作同樣在我們的農業垂直領域繼續進行，公司的滅蚊業務在 2022 年在實驗室安裝和從我們現有客戶群的持續採購方面實現了顯著增長。

We were also pleased to be able to introduce Dr. Mark Poritz as our scientific -- Chief Scientific Officer in the fourth quarter of 2022. Mark had previously served as the CSO of the subsidiary we acquired at the end of 2021 and has been actively involved in the development of the Co-Dx PCR Home since its inception. Dr. Poritz is a Harvard University in UC San Francisco Educated molecular biologists with more than 30 years of experience in the application of PCR and related methods and played a key role in the growth of BioFire Diagnostics, including in the development of the FilmArray platform.

我們也很高興能夠在 2022 年第四季度介紹 Mark Poritz 博士為我們的科學首席科學官。Mark 之前曾擔任我們在 2021 年底收購的子公司的 CSO，並一直積極參與自 Co-Dx PCR Home 成立以來一直參與其開發。 Poritz 博士是哈佛大學舊金山分校受過教育的分子生物學家，在 PCR 和相關方法的應用方面擁有 30 多年的經驗，並在 BioFire Diagnostics 的成長中發揮了關鍵作用，包括在 FilmArray 平台的開發中。

Lastly, as a further indication of our commitment to a successful product launch, Co-Dx has also deepened its industry experience by recently adding Rachel Jones as our Head of Technical Marketing, Rachel is the former Chief Commercial Officer at BioFire Diagnostics, where she built and led the commercial team responsible for the successful launch of syndromic, infectious disease diagnostics.

最後，作為我們對成功推出產品的承諾的進一步表明，Co-Dx 還通過最近任命 Rachel Jones 為我們的技術營銷主管來加深其行業經驗，Rachel 是 BioFire Diagnostics 的前首席商務官，她在那裡建立並帶領商業團隊成功推出了綜合症、傳染病診斷工具。

Overall, we believe our advancements in our at-home point-of-care, real-time PCR testing platform, team of experts working diligently to achieve our shared company vision, growing product pipeline and our practice of letting financial intelligence drive our smart spending during 2022, position Co-Diagnostics to execute against our strategic growth initiatives.

總的來說，我們相信我們在家庭護理點、實時 PCR 檢測平台、專家團隊努力工作以實現我們共同的公司願景、不斷增長的產品管道以及我們讓金融情報推動我們的明智支出的實踐方面的進步在 2022 年期間，定位 Co-Diagnostics 以執行我們的戰略增長計劃。

Our continued investments in talent and R&D remain positive indicators of the progress we are achieving to drive further value for our shareholders. This concludes my initial remarks.

我們對人才和研發的持續投資仍然是我們為股東創造更多價值所取得進展的積極指標。我的初步發言到此結束。

Let me now turn the time over to Brian Brown for a review of the key metrics and numbers. Brian?

現在讓我把時間交給 Brian Brown 來回顧一下關鍵指標和數字。布萊恩？

Thanks, Dwight and thanks to everyone who joined today's call. During 2022, we were up against a very difficult comparison due to the strong demand for COVID testing in 2021.

謝謝 Dwight，也感謝所有參加今天電話會議的人。在 2022 年期間，由於 2021 年對 COVID 測試的強烈需求，我們面臨著非常困難的比較。

For fiscal year 2022, and revenue decreased 65.0% to $34.2 million as compared to $97.9 million for fiscal 2021. The decrease in revenue on a year-over-year basis was primarily driven by the global decline in COVID testing.

與 2021 財年的 9790 萬美元相比，2022 財年的收入下降了 65.0% 至 3420 萬美元。收入同比下降的主要原因是全球 COVID 測試的減少。

Gross profit for the year decreased to $28.7 million compared to $86.3 million in fiscal 2021. Our gross margin percentage of 84.0% for the year decreased from 88.2% in 2021 as a result of lower volumes and corresponding higher percentage of fixed versus variable costs in production as compared to the prior year.

與 2021 財年的 8630 萬美元相比，本年度的毛利潤下降至 2870 萬美元。由於產量下降以及生產中固定成本與可變成本的相應百分比較高，我們本年度的毛利率從 2021 年的 88.2% 下降至 84.0%與上一年相比。

Total operating expenses for the 12 months ended December 31, 2022, were $55.7 million compared to $40.2 million in fiscal 2021. The year-over-year increase can be attributed to a goodwill impairment charge we recognized in the fourth quarter following the completion of our required goodwill and intangible impairment testing. The impairment to goodwill of $15.4 million can be attributed solely to the decline in our share price since completing the acquisitions of Idaho Molecular Inc. and Advanced Conceptions, Inc. at the end of 2021.

截至 2022 年 12 月 31 日的 12 個月的總運營費用為 5570 萬美元，而 2021 財年為 4020 萬美元。同比增長可歸因於我們在完成我們的業務後第四季度確認的商譽減值費用需要進行商譽和無形資產減值測試。 1540 萬美元的商譽減值完全可以歸因於自 2021 年底完成對 Idaho Molecular Inc. 和 Advanced Conceptions, Inc. 的收購以來我們的股價下跌。

Although we determined the goodwill related to the acquisitions to be impaired due to the lower share price, our valuation confirmed that it was not necessary to take any impairment charges on the related acquired technology, which is the technology behind our Co-Dx PCR Home platform. This technology or in-process R&D is presented as intangible assets on the balance sheet.

儘管我們確定與收購相關的商譽因較低的股價而減值，但我們的估值確認沒有必要對相關收購技術（即我們的 Co-Dx PCR Home 平台背後的技術）計提任何減值費用.該技術或在製品研發在資產負債表中列示為無形資產。

We are committed to the success of our growth initiatives, which is shown by increased research and development expenses most of which are related to the continued investment in our at-home and point-of-care Co-Dx PCR Home platform.

我們致力於實現我們的增長計劃的成功，這體現在研發費用的增加，其中大部分與我們對家庭和床旁護理 Co-Dx PCR Home 平台的持續投資有關。

The increased spend on research and development was primarily offset by a $6.1 million decrease in sales and marketing expenses, driven by reduced third-party commissions and variable compensation.

研發支出的增加主要被銷售和營銷費用減少 610 萬美元所抵消，這是由第三方佣金減少和可變薪酬推動的。

For the full year, we recognized a loss before taxes totaling $18.8 million as compared to income before taxes of $45.6 million in the prior year same period. The loss can be attributed to decreased global demand for COVID testing and the $15.4 million goodwill impairment charge.

對於全年，我們確認了總計 1880 萬美元的稅前虧損，而去年同期的稅前收入為 4560 萬美元。虧損可歸因於全球對 COVID 測試的需求減少以及 1540 萬美元的商譽減值費用。

Income tax benefit for the year was $4.6 million, representing an effective tax rate of 24.5%. Our effective tax rate will generally differ from the U.S. federal statutory rate of 21.0%, due to state taxes, permanent items and discrete items.

當年的所得稅收益為 460 萬美元，有效稅率為 24.5%。由於州稅、永久項目和離散項目，我們的有效稅率通常不同於美國聯邦法定稅率 21.0%。

Net loss for fiscal 2022 was $14.2 million or a loss of $0.45 per fully diluted share compared to net income of $36.7 million or $1.23 per fully diluted share in the prior year.

2022 財年的淨虧損為 1420 萬美元或每股完全攤薄後虧損 0.45 美元，而上一年的淨收入為 3670 萬美元或每股完全攤薄後虧損 1.23 美元。

The year-over-year decrease was primarily the result of lower testing volumes as well as the previously mentioned noncash impairment charge. Excluding the onetime goodwill impairment charge for our previously purchased subsidiaries, we generated $1.2 million in adjusted net income or $0.04 per fully diluted share in fiscal 2022. This compares to the $36.7 million of adjusted net income in 2021 or $1.23 per fully diluted share.

同比下降主要是由於測試量減少以及前面提到的非現金減值費用。不包括我們之前購買的子公司的一次性商譽減值費用，我們在 2022 財年產生了 120 萬美元的調整後淨收入或每股完全攤薄收益 0.04 美元。相比之下，2021 年的調整後淨收入為 3670 萬美元或每股完全攤薄收益 1.23 美元。

Adjusted net income is defined as net income adjusted for goodwill impairment charges. A reconciliation of net income to adjusted net income has been provided in our earnings release and 8-K filed shortly after market close.

調整後的淨收入定義為針對商譽減值費用調整的淨收入。我們的收益發布和收市後不久提交的 8-K 中提供了淨收入與調整後淨收入的對賬。

For the year ended December 31, 2022, we generated $3.1 million of adjusted EBITDA loss as compared to the adjusted EBITDA gain of $51.6 million in the prior year. Impairment of goodwill is excluded from the adjusted EBITDA calculations.

截至 2022 年 12 月 31 日止年度，我們產生了 310 萬美元的調整後 EBITDA 虧損，而上一年調整後的 EBITDA 收益為 5160 萬美元。調整後的 EBITDA 計算不包括商譽減值。

We remain committed to maintaining the health and flexibility of our balance sheet. Cash, cash equivalents and marketable securities totaled $81.3 million at December 31, 2022, as compared to $89.9 million at December 31, 2021. Even with the headwinds of 2022 for the 12 months ended December 31, 2021, we generated $6.6 million of positive cash flow from operations.

我們仍然致力於保持資產負債表的健康和靈活性。截至 2022 年 12 月 31 日，現金、現金等價物和有價證券總計 8130 萬美元，而 2021 年 12 月 31 日為 8990 萬美元。即使在 2022 年截至 2021 年 12 月 31 日的 12 個月中出現逆風，我們仍產生了 660 萬美元的正現金從操作流。

While our primary focus during fiscal 2022 was to advance the progress of our at-home and point-of-care PCR platform, we remain encouraged with our liquidity position and the absence of debt on our balance sheet.

雖然我們在 2022 財年的主要重點是推進我們的家庭和床旁 PCR 平台的進展，但我們仍然對我們的流動性狀況和資產負債表上沒有債務感到鼓舞。

During the year, we repurchased 3.9 million shares at an average price of $3.66 per share for an aggregate price of approximately $14.2 million. Our solid financial position gives us flexibility to continue to invest in and grow our business and to opportunistically allocate capital with the goal of maximizing long-term value for shareholders.

年內，我們以每股 3.66 美元的平均價格回購了 390 萬股股票，總價約為 1,420 萬美元。我們穩固的財務狀況使我們能夠靈活地繼續投資和發展我們的業務，並以機會主義的方式分配資本，以實現股東長期價值的最大化。

Turning now to our guidance. We continue to take a prudent view on both current industry and macro trends due to the lack of consistent stability in COVID test demand as well as the continued shift in the market to multiplex testing for respiratory illnesses, it is difficult to actually provide financial guidance at this time.

現在轉向我們的指導。由於 COVID 測試需求缺乏持續穩定以及市場持續轉向呼吸系統疾病的多重測試，我們繼續對當前行業和宏觀趨勢持謹慎態度，因此很難實際提供財務指導這次。

While we assume the demand for COVID test will not return to pandemic levels, our healthy balance sheet will enable us to invest in our business, specifically our at-home and point-of-care Co-Dx PCR Home platform. And we will continue to consider additional ways to increase returns and create greater value for shareholders.

雖然我們假設對 COVID 測試的需求不會恢復到大流行的水平，但我們健康的資產負債表將使我們能夠投資於我們的業務，特別是我們的家庭和護理點 Co-Dx PCR Home 平台。我們將繼續考慮其他方式來增加回報並為股東創造更大的價值。

We are encouraged by the commencement of clinical evaluations for our at-home and point-of-care CO-Dx PCR Home platform. The commencement of these evaluations announced in February represents the achievement of a profound milestone for our company. We expect to continue to invest our current assets in support of clinical trials and other research and development initiatives.

我們對開始對我們的家庭和護理點 CO-Dx PCR Home 平台進行臨床評估感到鼓舞。 2 月份宣布的這些評估的開始標誌著我們公司實現了一個具有深遠意義的里程碑。我們希望繼續投資我們的現有資產，以支持臨床試驗和其他研發計劃。

Our solid cash position provides us with the foundation to navigate near-term uncertainty and deploy capital in a disciplined manner in support of our long-term strategy. We believe 2023 will be a monumental year for the company and one that will position us for the long-term future.

我們穩固的現金狀況為我們提供了應對近期不確定性和以有紀律的方式部署資本以支持我們的長期戰略的基礎。我們相信 2023 年對公司來說將是具有里程碑意義的一年，這將使我們為長期的未來做好準備。

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

有了這個，我現在將把演示文稿轉回給德懷特。德懷特？

Thank you, Brian. We'll now take calls from our analysts. Operator?

謝謝你，布萊恩。我們現在將接聽分析師的電話。操作員？

(Operator Instructions) We will take our first question, which will come from Yi Chen with H.C. Wainwright.

（操作員說明）我們將提出我們的第一個問題，該問題將來自 Yi Chen 和 H.C.溫賴特。

My first question is, could you comment on the current enrollment speed of the ongoing clinical trial of the Co-Dx PCR Home device and whether the speed up enrollment is meeting your expectations?

我的第一個問題是，您能否評論一下目前正在進行的 Co-Dx PCR Home 設備臨床試驗的註冊速度以及加速註冊是否符合您的預期？

I can't comment Yi, on the number of patients that have enrolled. We are having to enroll a certain number of both people who are symptomatic and asymptomatic. And as we said before in our remarks, because of the uncertainty that we won't be giving sort of regular updates on exactly what that enrollment is. Keep in mind, this is a clinical trial and support of an FDA emergency use authorization.

我不能評論 Yi，關於已登記的患者數量。我們必須招募一定數量的有症狀和無症狀的人。正如我們之前在評論中所說，由於存在不確定性，我們不會就註冊人數的確切情況提供定期更新。請記住，這是一項臨床試驗並支持 FDA 緊急使用授權。

So the number of patients that are required to fulfill that type of submission is not onerous, it's a relatively small cohort of patients. So we're not expecting to have a protracted period of time, but we just don't know. It depends on what's the rate of infection that's going on in these 5 areas where we have sites dedicated. But this is going to be an ongoing situation for the next, I suppose, several months. That will then give us the data that we need to compile the analytics for the FDA.

因此，完成此類提交所需的患者數量並不繁重，這是一個相對較小的患者隊列。所以我們不希望有一段很長的時間，但我們只是不知道。這取決於我們有專門站點的這 5 個區域的感染率。但我想，在接下來的幾個月裡，這將是一個持續的情況。然後，這將為我們提供為 FDA 編譯分析所需的數據。

And the enrollment that has occurred up to this point is consistent with our expectations.

到目前為止發生的註冊情況與我們的預期一致。

Okay. And could you also comment on how many sales rep would it take to successfully market this product when it's approved by the FDA?

好的。您能否也評論一下，當該產品獲得 FDA 批准後，需要多少銷售代表才能成功推向市場？

Well, let me start that answer by saying, I think that we're in the main pretty fully staffed in terms of our sales reps. We have a very strong cohort of representatives that are operating out of our headquarters here in Salt Lake City, Utah. And as I mentioned in the call, we just brought on in January, Rachel Jones, who is a bonafied superior industry expert in this area. And she is part of the team as a full-time employee. And we have lots of opportunity in several key verticals that we have been analyzing along with our field market research that's helping us to focus in on the right areas. And we continue to nail down key launch markets.

好吧，讓我開始回答這個問題，我認為就我們的銷售代表而言，我們主要是人手充足。我們有一群非常強大的代表，他們在我們位於猶他州鹽湖城的總部開展業務。正如我在電話中提到的，我們剛剛在 1 月份聘請了 Rachel Jones，她是該領域的一位優秀的行業專家。她作為全職員工是團隊的一員。我們在幾個關鍵的垂直領域有很多機會，我們一直在分析這些垂直領域以及我們的現場市場研究，這有助於我們專注於正確的領域。我們繼續確定關鍵的發布市場。

So at this point, Yi, I think we're in the main ready to go fully staffed to attack. I don't -- we may add here and there and some support in clerical things. But if you do the numbers, and I encourage you to do so, if you take a look at the number of Co-Dx PCR Home platform modules that need to be sold, the instruments, it's not a huge number along with the required consumable cups to drive significant revenues for the company.

所以在這一點上，易，我認為我們主要準備好全力以赴進攻。我不——我們可能會在這里和那裡添加一些文書方面的支持。但是如果你計算數字，我鼓勵你這樣做，如果你看一下需要出售的 Co-Dx PCR Home 平台模塊的數量，儀器，以及所需的消耗品，這並不是一個巨大的數字杯子為公司帶來可觀的收入。

And I think we have on board already what we need there. And much of the other things that we need in terms of back-end support and shipping and customer support, those are all at advanced stages of development that we have done in preparation for launch. So we're fine-tuning the key launch markets, but I think we're in the main pretty well dressed with what we need to do it from a personnel standpoint.

而且我認為我們已經準備好了我們在那裡需要的東西。我們在後端支持、運輸和客戶支持方面需要的許多其他東西，這些都處於我們為發布做準備的高級開發階段。所以我們正在微調關鍵的發射市場，但我認為從人員的角度來看，我們基本上已經準備好了我們需要做的事情。

Got it. And my last question is, would you be able to secure reimbursement from CMS and also private payers for tests conducted on this platform?

知道了。我的最後一個問題是，對於在此平台上進行的測試，您能否從 CMS 和私人付款人處獲得報銷？

Yi, that is something that's an ongoing process. We're, of course, watching what's going on with all of our competitors in the context of reimbursement. And we will be doing our own attempt at stimulating reimbursement for the markets that we serve.

易，這是一個持續的過程。當然，我們正在關注我們所有競爭對手在報銷方面的進展。我們將自己嘗試刺激我們服務的市場的報銷。

And our next question will come from Theodore O'Neill with Litchfield Hills Research.

我們的下一個問題將來自 Litchfield Hills Research 的 Theodore O'Neill。

I recognize that you don't want to give out any milestones for the Co-Dx PCR. But if this works pretty much as you expect, this ought to be a product before the end of 2024. Can I make that assumption?

我知道您不想給出 Co-Dx PCR 的任何里程碑。但如果這和你預期的一樣有效，那麼這應該是 2024 年底之前的產品。我可以做出這樣的假設嗎？

I'm very comfortable with that assumption Theo. I mean frankly, it's got to be a lot earlier from our standpoint than 2024 in terms of our expectations, let's put it that way. I mean these clinical trials should not drag on indefinitely, they should be able to be completed in due course. And then we do the analytics that are driven by the data. And then -- and we do our submission. And we have a device that is -- it represents a lot of great new technology. It emphasizes at-home and point-of-care. These are areas that the FDA has stated that they are interested in, let's say, from a priority standpoint. So we expect -- we don't know this, but we expect that we will get appropriate attention from the regulators in terms of getting this onto the market.

我對 Theo 的假設很滿意。我的意思是，坦率地說，從我們的角度來看，就我們的預期而言，它必須比 2024 年早得多，讓我們這樣說吧。我的意思是這些臨床試驗不應該無限期地拖下去，它們應該能夠在適當的時候完成。然後我們進行由數據驅動的分析。然後——然後我們提交。我們有一個設備——它代表了許多偉大的新技術。它強調在家和護理點。比方說，從優先級的角度來看，這些是 FDA 表示他們感興趣的領域。所以我們預計——我們不知道這一點，但我們預計我們會在將其推向市場方面得到監管機構的適當關注。

I think people who look at our product and look at its capabilities in terms of real-time PCR and the ability to set up a terrific surveillance sort of system in terms of being in the cloud for the diagnostics and the data availability to health care professionals and doctors and state health departments and such. And when they look at the accuracy of the test and when they look at the fact that we can multiplex in sort of a class by ourselves because we're not only using PCR, we're using CoPrimers, which enhances the ability to multiplex measurably.

我認為那些關注我們產品並關注其實時 PCR 功能的人，以及在雲中為醫療保健專業人員提供診斷和數據可用性方面建立出色監控系統的能力以及醫生和國家衛生部門等。當他們查看測試的準確性時，當他們查看我們可以自己進行多路復用的事實時，因為我們不僅使用 PCR，還使用 CoPrimers，這增強了可測量的多路復用能力.

And so I mean, if I can be so bold as to just say we believe our product is at the top of the heap in terms of specifications, and we think it is the best also in terms of price. And ultimately, we think this comes down to pricing specifications from a competitive standpoint. And I think we win the race on both of those metrics.

所以我的意思是，如果我可以大膽地說，我們相信我們的產品在規格方面處於領先地位，而且我們認為它在價格方面也是最好的。最終，我們認為從競爭的角度來看，這歸結為定價規範。我認為我們在這兩個指標上都贏得了比賽。

Okay. And Brian, a question for you. I'm just trying to get my head around the goodwill impairment charge and the gain on remeasurement of acquisition contingencies. If those are both related to Idaho Molecular and Advanced Conceptions, could I simplistically net those 2 together?

好的。布賴恩，有一個問題要問你。我只是想了解商譽減值費用和重新衡量收購或有費用的收益。如果這些都與 Idaho Molecular 和 Advanced Conceptions 相關，我可以簡單地將這 2 個聯繫在一起嗎？

Simplistically, maybe you could for now, but here's the difference is when you impair goodwill, it never gets written back up, it's gone forever. On the revalue, the remeasurement of those contingencies, as the stock price goes back up, we will have to increase the value of those, which will automatically it will take a hit on the P&L where we've taken the gain for the year. So that's the difference between the 2. Yes.

簡單地說，也許你現在可以，但不同之處在於，當你損害商譽時，它永遠不會被回寫，它永遠消失了。關於重估，重新衡量這些意外事件，隨著股價回升，我們將不得不增加這些事件的價值，這將自動對我們今年取得收益的損益表造成打擊。這就是兩者之間的區別。是的。

And this concludes our question-and-answer session. I'd like to turn the conference back over to Dwight Egan for any closing remarks.

我們的問答環節到此結束。我想將會議轉回 Dwight Egan 的閉幕詞。

Well, it's no secret that COVID created a fulcrum that allowed Co-Diagnostics to leverage our state-of-the-art patented CoPrimer PCR technology to help more people than ever before and increase our profile, both domestically and internationally. But more important than what we have done is what we believe we will yet accomplish.

眾所周知，COVID 創造了一個支點，使 Co-Diagnostics 能夠利用我們最先進的專利 CoPrimer PCR 技術幫助比以往更多的人，並提高我們在國內和國際上的知名度。但比我們所做的更重要的是我們相信我們將要完成的事情。

In short, our greatest impact is yet to come, a device that is the first to market is less significant than the device that is the first to do it right. And that has been our goal since the beginning.

簡而言之，我們最大的影響尚未到來，第一個上市的設備不如第一個正確使用它的設備重要。這從一開始就是我們的目標。

We are pleased with the progress the company has made in developing a long-term strategy around our exceptional new Co-Dx PCR Home platform, not just for COVID but for a whole range of diseases, such as flu, RSV, STIs, tuberculosis and others. Whether through the new platform, our existing and successful centralized laboratory vertical, or even by providing PCR tools for vector control services to be more efficient and effective, our mission remains the same, preserving life by reducing the spread of infectious disease and making our robust gold standard real-time PCR testing solutions available to as many people in as many places as possible.

我們很高興公司在圍繞我們卓越的新型 Co-Dx PCR Home 平台製定長期戰略方面取得的進展，不僅針對 COVID，還針對各種疾病，例如流感、RSV、STI、結核病和其他的。無論是通過新平台、我們現有的和成功的垂直垂直實驗室，還是通過提供 PCR 工具來提高病媒控制服務的效率和效果，我們的使命都是一樣的，即通過減少傳染病的傳播來保護生命，並使我們的強大黃金標準實時 PCR 檢測解決方案可供盡可能多的人在盡可能多的地方使用。

Thank you to our shareholders as well as to the whole Co-Dx family of employees, distributors and consultants for joining us in this broad and significant undertaking. We look forward to talking with you again after the next quarter.

感謝我們的股東以及 Co-Dx 全體員工、經銷商和顧問加入我們這一廣泛而重要的事業。我們期待在下個季度後再次與您交談。

The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.

會議現已結束。非常感謝您參加今天的演講。您現在可以斷開線路。