Cue Health Inc (HLTH) 2023 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Cue Health fourth-quarter 2023 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加 Cue Health 2023 年第四季財報電話會議。（操作員指示）請注意，今天的會議正在錄製中。

I'd now like to hand the conference over to Caroline Corner, Investor Relations. Please go ahead.

我現在想將會議交給投資者關係部門的卡洛琳‧科納 (Caroline Corner)。請繼續。

Good afternoon, and welcome to Cue's fourth-quarter and full year 2023 earnings conference call. Joining me today are Ayub Khattak, Chairman and Chief Executive Officer of Cue Health; and Aasim Javed, Chief Financial Officer.

下午好，歡迎參加 Cue 的第四季和 2023 年全年財報電話會議。今天與我一起出席的還有 Cue Health 董事長兼執行長 Ayub Khattak；和財務長 Aasim Javed。

Before we get started, let me begin by reminding you that we may be making forward-looking statements, including statements related to the submission of any FDA applications and expectations around receiving clearance and authorization, expectations regarding production capacity, expectations related to the availability of our programs and testing volumes, the expected performance of our business, future financial results and guidance strategy, long-term growth and overall future prospects as well as the impact of the COVID-19 pandemic.

在我們開始之前，讓我先提醒您，我們可能會做出前瞻性聲明，包括與提交任何 FDA 申請相關的聲明以及對獲得許可和授權的期望、對生產能力的期望、與可用性相關的期望我們的計劃和測試量、我們業務的預期業績、未來的財務表現和指導策略、長期成長和整體未來前景以及COVID-19 大流行的影響。

These statements are subject to risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from those described. These risks and uncertainties include, but are not limited to those outlined in today's call as well as other risks identified from time to time in our public statements and reports filed with the SEC.

這些陳述受到風險、不確定性、假設和其他因素的影響，這些因素可能導致實際結果與所描述的結果有重大差異。這些風險和不確定性包括但不限於今天的電話會議中概述的風險和不確定性，以及我們向 SEC 提交的公開聲明和報告中不時發現的其他風險。

Forward-looking statements that we make on this call are based on assumptions and belief as of the date they are made, and the company disclaims any obligations to update these statements except as required by law. In addition, on today's call, non-GAAP financial measures will be used. Reconciliations between GAAP and non-GAAP financial measures are included in our earnings release.

我們在本次電話會議中所做的前瞻性陳述是基於截至做出之日的假設和信念，除法律要求外，本公司不承擔任何更新這些陳述的義務。此外，在今天的電話會議上，將使用非公認會計準則財務指標。公認會計原則和非公認會計原則財務指標之間的調節包含在我們的收益發布中。

Finally, I would like to mention that the press release and a recording of this call are available on the Investor Relations page of our website.

最後，我想提一下，我們網站的投資者關係頁面上提供了本次電話會議的新聞稿和錄音。

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

說到這裡，我想把電話轉給阿尤布。

Thank you, Caroline, and thank you, everyone, for joining us today. We're excited to share our fourth-quarter results and significant progress we made in 2023. We reported total revenue of $19 million in the fourth- quarter ahead of our guidance, driven by strong pull-through of our installed base of key leaders and the continued adoption of our innovative Cue Integrated Care Platform.

謝謝卡羅琳，也謝謝大家今天加入我們。我們很高興分享我們第四季度的業績以及我們在 2023 年取得的重大進展。我們公佈的第四季度總收入為 1,900 萬美元，高於我們的指引，這得益於我們主要領導者安裝基礎的強勁拉動以及我們創新的 Cue 綜合護理平台的持續採用。

2023 was a year of significant milestones for Cue, we obtained two FDA authorizations, specifically a de novo approval for at-home and point-of-care COVID-19 Molecular Tests, the first molecular diagnostic and the first respiratory test ever to receive a full FDA approval for home use.

2023 年對Cue 來說是具有重要里程碑意義的一年，我們獲得了兩項FDA 授權，特別是對家庭和護理點COVID-19 分子測試的從頭批准，這是第一個分子診斷和第一個呼吸測試FDA 完全批准家庭使用。

And authorization for health molecular and Mpox test, our first sexual health test. In 2023, we also submitted our RSV test and flu test for de novo approval and were awarded a nearly $30 million contract from barter to develop all the way through for regulatory authorization. A combined test, for flu, COVID-19 and RSV for home and professional use.

並獲得健康分子和 Mpox 測試的授權，這是我們的第一個健康測試。2023 年，我們還提交了 RSV 測試和流感測試以獲得重新批准，並從以物易物公司獲得了一份近 3000 萬美元的合同，以進行全程開發以獲得監管授權。針對流感、COVID-19 和 RSV 的全面測試，適合家庭和專業用途。

In addition to our work on our flagship Cue Health Monitoring System menu, we have also expanded our Cue Integrated Care Platform offerings significantly in 2023. We now offer 16 home collection test kits to our Cue lab product line, including test kits for categories like heart health and sexual health. Through Cue lab we empower individuals to conveniently collect samples at home, obtain their lab results digitally and interact with clinicians for lab results, interpretation and follow-up action.

除了我們在旗艦 Cue 健康監測系統選單方面的工作外，我們還在 2023 年大幅擴展了 Cue 綜合護理平台產品。我們現在為 Cue Lab 產品線提供 16 種家庭收集測試套件，包括心臟健康和性健康等類別的測試套件。透過 Cue lab，我們使個人能夠在家中方便地收集樣本，以數位方式獲取實驗室結果，並與臨床醫生互動以了解實驗室結果、解釋和後續行動。

Rounding out our offering on the treatment side, we've extended our original lead time prescription and delivery capability for infectious diseases like COVID-19 and flu to provide treatments for many more common health needs. For example, our treatment offerings now include therapeutics for sexually transmitted infection, GLP-1s for weight management and antiviral for cold source.

為了完善我們在治療方面的產品，我們延長了 COVID-19 和流感等傳染病的原始處方交付時間和交付能力，為許多更常見的健康需求提供治療。例如，我們的治療產品現在包括性傳染感染療法、體重管理 GLP-1 和冷源抗病毒藥物。

In short, we're proud of the great progress we made in 2023 and driving forward our vision of empowering people to live their healthiest lives. And we accomplished all this while streamlining our operations over the last year, reducing our cost structure by over $200 million on an annualized basis. These milestones have positioned us for an exciting 2024, and we are anticipating significant progress on our number one strategic priority menu expansion on the Cue Health Monitoring System.

簡而言之，我們為 2023 年的巨大進步感到自豪，並推動我們實現讓人們過上最健康生活的願景。去年，我們在簡化營運的同時實現了這一切，將我們的成本結構按年計算減少了 2 億多美元。這些里程碑使我們能夠迎接令人興奮的 2024 年，我們預計 Cue 健康監測系統的第一戰略優先菜單擴展將取得重大進展。

Looking ahead, now I'd like to provide some updates on test menu expansion for the Cue Health Monitoring System. First, the Cue RSV Molecular Test was submitted to the FDA for de novo approval last May and we received in response to FDA's feedback, we were asked to provide additional clinical data reflecting the addition of more intense and elderly into our clinical population. We successfully executed the clinical studies to collect additional data, so very good performance and submitted the additional data to FDA.

展望未來，現在我想提供有關 Cue 健康監測系統測試選單擴充的一些更新。首先，Cue RSV 分子測試於去年 5 月提交給 FDA 進行重新批准，我們收到了 FDA 反饋的回應，要求我們提供額外的臨床數據，反映我們的臨床人群中增加了更強烈和老年人。我們成功地進行了臨床研究，收集了更多數據，表現得非常好，並向 FDA 提交了額外數據。

We anticipate an approval for RSV to come in the third-quarter of this year. Once we have approval, it's our intention to immediately launch the test to our customers for use with our installed base of over a quarter million Cue readers. Additionally, we believe that approval of additional tests in our pipeline will help grow our installed reader base. Our flu molecular tests is also meant to the FDA for de novo approval last year.

我們預計 RSV 將於今年第三季獲得批准。一旦獲得批准，我們打算立即向客戶啟動測試，以便與我們超過 25 萬 Cue 閱讀器的安裝基礎一起使用。此外，我們相信，批准我們管道中的其他測試將有助於擴大我們的讀者群。我們的流感分子檢驗去年也已獲得 FDA 的重新批准。

During the review process, the FDA asked that we provide a greater number of clinical samples for Flu B, which has had a low instance over the last three years with almost no circulation in the Northern Hemisphere. We conducted additional clinical studies in the southern hemisphere, and we're able to collect a sufficient number of Flu B sample to meet the FDA's requirement. We are still working on providing additional stability data for a higher temperature storage as requested by the FDA. And thus, we would expect a de novo decision preclude later this year in the third-quarter.

在審查過程中，FDA 要求我們提供更多 B 型流感臨床樣本，該樣本在過去三年中病例數較低，在北半球幾乎沒有流通。我們在南半球進行了額外的臨床研究，我們能夠收集足夠數量的 B 型流感樣本來滿足 FDA 的要求。我們仍在努力按照 FDA 的要求提供更高溫度儲存的額外穩定性數據。因此，我們預計今年稍後將在第三季做出重新決定。

In January, we announced that the FDA had declined to [issue] new air for Flu COVID multiplex test. You may recall this is our first multiplex test submission and sites enabling use for both at home and point-of-care use. This test performed very well in our clinical studies for both flu and COVID-19 cover the feedback that the FDA had was primarily for us to use a different comparator test for COVID-19 and to provide more real-time stability data.

一月份，我們宣布 FDA 拒絕為流感新冠多重檢測[發放]新空氣。您可能還記得這是我們的第一個多重測試提交和可用於家庭和護理點使用的網站。該測試在我們針對流感和 COVID-19 的臨床研究中表現非常好，涵蓋了 FDA 的回饋，主要是讓我們對 COVID-19 使用不同的比較測試並提供更多即時穩定性數據。

We are in active dialogue with the FDA to address these items, we hope to resubmit this application and achieve optimization in the second half of the year. To complete our respiratory pipeline update, we're making strides with our combined flu, RSV and COVID, all in one multiplex test, supported by $28 million barter contract.

我們正在與FDA積極對話解決這些問題，希望下半年重新提交申請並實現最佳化。為了完成我們的呼吸管道更新，我們正在將流感、RSV 和 COVID 結合起來，在一項多重測試中取得進展，並得到 2800 萬美元的以物易物合約的支持。

We plan to start clinical trials this summer in the southern hemisphere and aim to have this test on market by the end of 2024 as an EUA progressing to a full clearance in 2025. We have planned this two-stage approach to getting to market with this test. And the program is funded through the full clearance.

我們計劃今年夏天在南半球開始臨床試驗，並計劃在 2024 年底前將測試推向市場，EUA 將於 2025 年獲得全面批准。我們計劃採用兩階段的方法來透過此測試進入市場。該計劃的資金是透過全面審批獲得的。

Stage one is the EUA regulatory pathway. And in support of Stage two, we'll continue our clinical studies throughout the respiratory season in the Northern Hemisphere as we enter and plan to submit for full clearance next year.

第一階段是 EUA 監管途徑。為了支持第二階段，我們將在北半球的整個呼吸季節繼續進行臨床研究，並計劃明年提交全面許可。

Moving to our menu expansion efforts in the sexual health category. We are in late-stage development and plan to submit our Herpes plus Mpox Multiplex tests under an EUA. We've had constructive conversations with the FDA regarding our validation plan for our submission. This test will allow us to build our Mpox authorization last year to sort of the very large underserved of chronic care Herpes testing market.

轉向我們在性健康類別中的菜單擴展工作。我們正處於後期開發階段，並計劃根據 EUA 提交我們的 Herpes plus Mpox Multiplex 測試。我們已經與 FDA 就我們提交的驗證計劃進行了建設性對話。這項測試將使我們能夠在去年獲得 Mpox 授權，以進入服務水平非常低的慢性護理皰疹測試市場。

With the addition of Herpes, this test has strong potential to be a go-to test for anyone experiencing a lesion in the sexual health context. We still plan to submit for an EUA in Q2 2024 and would expect to receive authorization by year end.

由於添加了皰疹，該測試很有可能成為任何在性健康方面經歷病變的人的首選測試。我們仍計劃在 2024 年第二季提交 EUA，並預計在年底前獲得授權。

Moving to our Chlamydia and Gonorrhea test, the test is development complete and ready to enter into clinical studies. We have sites contracted and the IRB process is complete. However, we strategically decided to delay the start of our clinical studies for chlamydia and gonorrhea tests to preserve cash in the near term.

轉向我們的衣原體和淋病測試，該測試已開發完成並準備進入臨床研究。我們已經簽訂了場地合同，IRB 流程也已完成。然而，我們策略性地決定推遲衣原體和淋病檢測臨床研究的開始，以在短期內保留現金。

This action is similar to what we decided with the strep throat program. We remain committed to our full pipeline in respiratory and sexual health testing while being mindful of the need to balance near term cost and long-term opportunity and feel we have a very strong near-term pipeline both categories.

這項行動與我們針對鏈球菌性咽喉炎計畫所做的決定類似。我們仍然致力於呼吸和性健康檢測的完整管道，同時注意平衡近期成本和長期機會的需要，並認為我們在這兩個類別中都擁有非常強大的近期管道。

As soon as we receive FDA authorization will be ready to launch into our existing sales channels and then continue progressing menu expansion, such as the chlamydia and gonorrhea and strep throat test through clinical studies. As a reminder, all the Cue Health Monitoring System tests show the same cartridge backbone and manufacturing process, including our combined Flu, COVID, RSV test.

一旦獲得 FDA 授權，我們將準備好進入我們現有的銷售管道，然後繼續進行菜單擴展，例如透過臨床研究進行衣原體和淋病以及鏈球菌性咽喉炎測試。提醒一下，所有 Cue 健康監測系統測試都顯示相同的濾芯骨幹和製造工藝，包括我們的流感、新冠肺炎、呼吸道合胞病毒組合測試。

Our new testing products will be made on our automated production lines without significant additional capital investment, with demonstrated reliable production at scale, [Olink] produced and sold over [17 million] molecular tests to date. As I mentioned earlier, we've made significant progress on the Cue Integrated Care Platform.

我們的新測試產品將在我們的自動化生產線上生產，無需大量額外資本投資，並已證明大規模生產可靠，[Olink] 迄今為止生產和銷售了超過 [1700 萬] 個分子測試。正如我之前提到的，我們在 Cue 綜合護理平台上取得了重大進展。

Our solution that seamlessly extends the capability of our foundational Cue Health Monitoring System. In its current form the platform enables end to end customer journey from obtaining an accurate diagnosis to consultation with a health care provider through our apps to receiving check payment via delivery or local pharmacy pickup.

我們的解決方案無縫擴展了我們基礎 Cue 健康監測系統的功能。在目前的形式下，該平台支援端到端的客戶旅程，從獲得準確的診斷到透過我們的應用程式向醫療保健提供者進行諮詢，再到透過送貨或當地藥房取貨接收支票付款。

We have integrated many of the building blocks of the last 18 months. In 2022, we launched Cue care, allowing for video consultation with clinicians and prescription delivery. Since then, we've seen traction with our installed base. And today we offer tests and treatments across the care spectrum, including not just antivirals but therapeutics ranging from GLP-1 two treatments for STI.

我們整合了過去 18 個月的許多建置模組。2022 年，我們推出了 Cue care，可以與臨床醫生進行視訊諮詢並提供處方。從那時起，我們就看到了我們的安裝基礎的吸引力。今天，我們提供涵蓋整個護理範圍的測試和治療，不僅包括抗病毒藥物，還包括從 GLP-1 到 STI 兩種治療方法的治療方法。

In summary, 2023 was a year of significant accomplishment by the team at Cue and we're well positioned for an exciting 2024 with a much lower cost structure as we continue to expand our test menu, drive adoption of our Integrated Care Platform and empower people to live their healthier lives. We look forward to updating you on the progress in the coming quarters.

總而言之，2023 年是Cue 團隊取得重大成就的一年，隨著我們繼續擴展我們的測試菜單、推動我們的綜合護理平台的採用並為人們提供支持，我們已做好充分準備，以更低的成本結構迎接令人興奮的2024 年過著更健康的生活。我們期待向您通報未來幾季的最新進展。

With that, I'll turn the call over to Aasim.

這樣，我會將電話轉給 Aasim。

Thank you, Ayub. And good afternoon. Now let's walk through our fourth-quarter financial results and first-quarter guidance. Cue's fourth-quarter total revenue was $18.8 million compared with $17.5 million in the third-quarter of 2023. In the quarter, our private sector contributed 91% or $17 million of sales. Public sector revenues were $1.8 million for the fourth-quarter. Total test cartridge sales were $15.5 million. Q4 product gross profit was a loss of $18.4 million adjusted for one-time inventory charges, product gross profit was a loss of $2.7 million. Gross profit is impacted by lower manufacturing volumes and includes noncash items.

謝謝你，阿尤布。午安.現在讓我們來看看我們的第四季度財務業績和第一季指引。Cue 第四季的總收入為 1880 萬美元，而 2023 年第三季的總收入為 1750 萬美元。本季度，我們的私營部門貢獻了 91% 的銷售額，即 1700 萬美元。第四季公共部門營收為 180 萬美元。測試盒總銷售額為 1550 萬美元。第四季產品毛利為虧損 1,840 萬美元，經一次性庫存費用調整後，產品毛利為虧損 270 萬美元。毛利受到產量下降的影響，其中包括非現金項目。

Excluding depreciation, amortization and stock-based compensation, our adjusted product gross profit would be positive. Total operating expenses in the quarter were $48.3 million, excluding cost of revenue and the noncash impairment of long-lived assets. Q4 operating expenses were down 49% from the year-ago quarter due to our cost reduction efforts.

排除折舊、攤提和股票薪酬，我們調整後的產品毛利將為正值。本季的總營運支出為 4,830 萬美元，不包括收入成本和長期資產的非現金減損。由於我們努力削減成本，第四季度營運費用比去年同期下降了 49%。

Sales and marketing expenses were $6.2 million in the fourth-quarter, a decrease of 68% from Q4 2022, driven by a decrease in payroll, digital and marketing costs. R&D expenses were $32.2 million for Q4, a decrease of 43% from $56.1 million of spend in Q4 2022. We continue to remain focused on the development of our near term menu. G&A expenses were $9.9 million during the quarter, a decline of 48% from Q4 2022 spend of $19.2 million.

由於工資、數位和行銷成本下降，第四季銷售和行銷費用為 620 萬美元，較 2022 年第四季下降 68%。第四季的研發費用為 3,220 萬美元，比 2022 年第四季的 5,610 萬美元減少了 43%。我們將繼續專注於近期菜單的開發。本季的一般管理費用為 990 萬美元，比 2022 年第四季的 1,920 萬美元下降 48%。

In the quarter, we recognized a noncash impairment charge of $83.6 million for some of our manufacturing lines due to low current volumes. Having said that, these lines are usable once volume picks up. As a result, GAAP net loss in the fourth-quarter was $148.4 million or $0.96 per share. Adjusted for one-time inventory and noncash impairment charges, net loss was $49.1 million or $0.32 per share. Adjusted EBITDA was a loss of $24.4 million.

本季度，由於目前產量較低，我們的一些生產線確認了 8,360 萬美元的非現金減損費用。話雖如此，一旦成交量回升，這些線路就可以使用。因此，第四季 GAAP 淨虧損為 1.484 億美元，即每股 0.96 美元。根據一次性庫存和非現金減損費用進行調整後，淨虧損為 4,910 萬美元，即每股 0.32 美元。調整後 EBITDA 虧損 2,440 萬美元。

Moving on to full year 2023, Cue's total revenue was $70.9 million. Private sector revenue accounted for 89% or $63 million, and public sector revenue accounted for 11% or $7.9 million. Test cartridge sales were $58.5 million in 2023. Adjusted product gross profit for 2023 was a loss of $35.2 million and exclude the disputed vendor payment and one-time inventory charges. Adjusted operating expenses for 2023 were $240.6 million. Excluding cost of revenue.

2023 年全年，Cue 的總收入為 7,090 萬美元。私部門收入佔89%，即6,300萬美元，公部門收入佔11%，即790萬美元。2023 年測試盒銷售額為 5,850 萬美元。2023 年調整後的產品毛利為虧損 3,520 萬美元，不包括有爭議的供應商付款和一次性庫存費用。2023 年調整後營運費用為 2.406 億美元。不包括收入成本。

Sales and marketing expense was $32.6 million. R&D expense was $150.6 million and G&A expense was $57.4 million, adjusted operating expenses exclude the previously mentioned impairment charge of long-lived assets and restructuring expenses. Adjusted net loss for the full year 2023 was $267.2 million or $1.75 per share. And adjusted EBITDA for the year was a loss of $163.8 million.

銷售和行銷費用為 3,260 萬美元。研發費用為 1.506 億美元，一般管理費用為 5,740 萬美元，調整後的營運費用不包括前面提到的長期資產減損費用和重組費用。2023 年全年調整後淨虧損為 2.672 億美元，即每股 1.75 美元。今年調整後的 EBITDA 虧損 1.638 億美元。

Moving to the balance sheet, we ended the year with cash of $80.9 million. And now I'd like to move to our guidance. We expect revenues of $9 million to $11 million for the first-quarter.

看看資產負債表，我們年底的現金為 8,090 萬美元。現在我想談談我們的指導。我們預計第一季的營收為 900 萬至 1,100 萬美元。

With that, I would like to thank you for your attention, and I'll now turn the call over to the operator for questions.

在此，我要感謝您的關注，現在我將把電話轉給接線員詢問問題。

(Operator Instructions)

（操作員說明）

Matt Sykes, Goldman Sachs.

馬特·賽克斯，高盛。

Good afternoon and thanks taking my questions. Maybe just first a for you just on menu expansion strategy. Just curious as how you're thinking about it now. I mean, I know you're submitting additional information on flu and RSV, but you've also got the barter contract for the multiplex test. Is there a rationale for continuing the work on this stand-alone tests and not just skipping to the multiplex, given you've got the funding from barter, like are there commercial reasons people still want stand-alone tests? Are you too far along in the kind of clinical trial portion to kind of give up on the stand-alone tests. I just would love to get kind of your thoughts on how you're thinking about that?

下午好，感謝回答我的問題。也許只是為您提供第一個菜單擴展策略。只是好奇你現在是怎麼想的。我的意思是，我知道您正在提交有關流感和 RSV 的附加信息，但您還獲得了多重測試的以物易物合約。考慮到你已經從以物易物貿易中獲得了資金，是否有理由繼續進行這種獨立測試的工作，而不僅僅是跳到多廳影院，例如人們仍然想要獨立測試是否有商業原因？您是否在臨床試驗部分已經走得太遠而無法放棄獨立測試？我只是想知道您對此有何想法？

Yeah. Thanks Matt, for the question. With RSV, we do have the de novos submitted. We already went and got the additional clinical data for infants and the elderly. We submitted, I feel really good about the performance, and we're just waiting for a decision at this point. And with flu, we have the de novo submitted, we went and got the additional Flu B per the FDA request feel really good about that clinical performance.

是的。謝謝馬特的提問。透過 RSV，我們確實提交了 de novos。我們已經去獲取了嬰兒和老年人的額外臨床數據。我們提交了，我對錶現感覺非常好，我們現在只是在等待決定。對於流感，我們從頭提交了申請，我們根據 FDA 的要求獲取了額外的 B 型流感，我們對臨床表現感到非常滿意。

And now we're just generating some stability, temperature stability, data, higher storage temperatures and you know, not only those, but we have the herpes and Mpox. Herpes is super, valuable and we see this as a transformative offering. It's really no additional point-of-care test. And then as you pointed out, flu, COVID, RSV, it's a really great opportunity on site.

現在我們只是產生一些穩定性、溫度穩定性、數據、更高的儲存溫度，你知道，不只這些，我們還有皰疹和MPox。皰疹是超級、有價值的，我們認為這是一個變革性的產品。這實際上不需要額外的現場護理測試。正如您所指出的，流感、​​新冠病毒、呼吸道合胞病毒，這確實是現場的絕佳機會。

It's fully funded by barter, it's in a really good place and so the way, we look at combo tests versus single tests. They both have a place in the market. There is no approved test for RSV in the home at all. And it's a valuable test in the point-of-care as well.

它完全由以物易物資助，它處於一個非常好的位置，因此我們將比較組合測試與單一測試。他們都在市場上佔有一席之地。根本沒有經過批准的家庭 RSV 測試。這對於現場護理來說也是一項有價值的測試。

So it's also a risk mitigation strategy you have, of course, a lot of people will prefer the Flu, COVID, RSV test over RSV test but at the same time, bring that test to market soon and then follow up with something that's has an additional capability, that's our strategy. And from a reimbursement perspective, in the point of care, it has different billing codes and so it could work really well to have both single target assays as well as combo test.

因此，這也是一種風險緩解策略，當然，許多人會更喜歡流感、新冠病毒、RSV 測試而不是 RSV 測試，但同時，請盡快將該測試推向市場，然後跟進一些具有實際意義的測試。額外的能力，這就是我們的策略。從報銷的角度來看，在護理方面，它具有不同的計費代碼，因此它可以很好地進行單目標檢測和組合測試。

Got it. Very helpful. Thank you. And then just any color you can provide on sort of the performance endours sort of materiality of revenues in the Cue lab business?

知道了。很有幫助。謝謝。然後，您可以提供任何顏色來說明 Cue 實驗室業務中收入的重要性嗎？

Yeah, from Cue lab to pharmacy standpoint, you know, we launched that last year. As you know, we're seeing some good trends there. We think it's a large market. So we think over time. This will be a meaningful part of business at this point, we're not breaking out those revenues.

是的，從 Cue 實驗室到藥房的角度來看，我們去年推出了它。如您所知，我們在那裡看到了一些良好的趨勢。我們認為這是一個很大的市場。所以我們會隨著時間的推移進行思考。目前這將是業務的一個有意義的部分，我們不會公佈這些收入。

Thank you very much.

非常感謝。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, guys can you hear me okay?

嘿，夥計們，你們聽得到我說話嗎？

Yes, we can here you.

是的，我們可以為您服務。

Great. So could you remind me of the size of the herpes and Mpox market, your decision to delay the CT/NG clinical studies or a little bit surprising, given that it's a well understood market, it's a very large market in so maybe could you just walk me through the rationale to delay that start of the CT/NG clinical studies? And maybe I understand the rationale of preserved cash, but can you just give us maybe a ballpark sense of what the clinical trial for CT/NG would cost as you pursue it relative to some of the other studies like herpes and Mpox?

偉大的。那麼，您能否提醒我皰疹和Mpox 市場的規模，您推遲CT/NG 臨床研究的決定，或者有點令人驚訝，因為這是一個眾所周知的市場，這是一個非常大的市場，所以也許您可以請告訴我延後 CT/NG 臨床研究開始的理由？也許我理解保留現金的基本原理，但您能否給我們大概介紹一下，當您相對於皰疹和 Mpox 等其他一些研究進行 CT/NG 臨床試驗時，其成本會是多少？

Yeah, good question. So herpes is the most common STV chlamydia & gonorrhea, very common as well. But herpes is the most common and the big difference here in terms of how we look at the sort of near term opportunity and the cash needs is that there is the EUA pathway for Mpox herpes combo. We already have the Mpox test authorized, and we're just building on that to add the herpes detection there.

是的，好問題。因此，皰疹是最常見的 STV，披衣菌和淋病也很常見。但皰疹是最常見的，就我們如何看待短期機會和現金需求而言，最大的區別在於 Mpox 皰疹組合有 EUA 途徑。我們已經獲得了 Mpox 測試的授權，我們只是在此基礎上添加皰疹檢測。

So it's a very different sort of regulatory costs or clinical study type cost comparison between herpes and pox and chlamydia gonorrhea. So chlamydia gonorrhea is very attractive market as well. But herpes and pox has an opportunity to be a really good market. But with a much different cost profile for getting it through authorization. So we see that as potentially much more near term to revenue and with much less cash out to be able to get that validation done for authorization. So that's really the key dynamic at play.

因此，皰疹、痘痘和淋病披衣菌之間的監管成本或臨床研究類型成本比較是非常不同的。因此淋病衣原體也是一個非常有吸引力的市場。但皰疹和痘痘有機會成為一個非常好的市場。但通過授權的成本情況卻大不相同。因此，我們認為，可能會更接近收入，並且需要更少的現金才能完成授權驗證。所以這確實是發揮作用的關鍵動力。

Okay. That makes sense. And then maybe a question on the update that you provided on January 4, 2024. With respect to the FDA feedback that you received on, I think you had indicated that the EUA request was not a priority. And so they decided they weren't going to advance review of the EUA COVID, yet you are planning to pursue herpes and Mpox as an EUA. Have you had conversations with the FDA about the EUA pathway. Just curious what your confidence is that would be a priority for the agency?

好的。這就說得通了。然後可能是關於您在 2024 年 1 月 4 日提供的更新的問題。關於您收到的 FDA 回饋，我認為您已表示 EUA 請求不是優先事項。因此，他們決定不提前審查 EUA COVID，但您計劃將皰疹和 Mpox 作為 EUA。您是否與 FDA 就 EUA 途徑進行對話？只是好奇您對該機構的優先事項有何信心？

Yeah. With flu COVID, we feel really good about the performance the effectiveness and the value of that test in particular, felt really good about the clinical performance. It's better than what we feel like we've seen in the market and then authorize so we've been working with the FDA. There's natural dialogue to see how we can get that test through the process and address the feedback they provided.

是的。對於流感新冠病毒，我們對測試的表現、有效性和價值感到非常滿意，特別是對臨床表現感到非常滿意。這比我們在市場上看到的然後授權的感覺要好，所以我們一直在與 FDA 合作。透過自然對話來了解我們如何透過整個過程進行測試並處理他們提供的回饋。

And as a reminder, we do have the Flu, COVID, RSV test and the way we're expecting to get that into clinical study this summer in the southern hemisphere. And that's going to have a two-stage approach so there's EUA pathway forward for this year, but we're also following through always, through the full submission, and that's all part of funded.

提醒一下，我們確實有流感、新冠病毒、RSV 測試，以及我們預計今年夏天在南半球將其納入臨床研究的方式。這將採用兩階段方法，因此今年有 EUA 途徑，但我們也將始終遵循完整提交的要求，這都是資助的一部分。

So with regards to, you know, the the sort of wording there. They are still looking at EUAs it's really just about addressing that feedback more than I think it is about how they prioritize it on that's the length that their language on. But I think that at the end of the day, it's really about them addressing feedback and getting the tests through the regulatory process.

因此，關於那裡的措辭。他們仍在考慮 EUA，這實際上只是為了解決這些回饋，而不是我認為他們如何根據他們的語言長度來優先考慮這些回饋。但我認為歸根結底，真正重要的是他們解決回饋問題並透過監管流程進行測試。

So yeah, certainly there are on time to market advantages for the EUA process. And so we want to continue to leverage that where we can, but that's not in place of the de novo. That's really just a staged approach. So I wouldn't say that EUA is a sort of permanent objective. It's sort of staged approach to getting to that full de novo like we did with COVID. We first got an EUA and we've got the de novo for it.

所以，是的，EUA 流程當然具有準時上市的優勢。因此，我們希望繼續盡可能地利用這一點，但這並不能取代從頭開始。這其實只是一種分階段的方法。所以我不會說 EUA 是一種永久目標。這是一種分階段的方法，可以像我們對待新冠病毒一樣從頭開始。我們首先獲得了 EUA，並從頭開始。

Okay. Got it. And then maybe one for Aasim. And just as we think about extending the cash runway. Obviously, you announced another workforce reduction in January. Just can you give us a sense for was that a $30 million use of cash in Q4 and maybe walk me through how you're thinking about cash utilization per quarter here in '24?

好的。知道了。然後也許是給阿西姆的。正如我們考慮擴大現金跑道。顯然，您在一月份宣布了另一次裁員。您能否告訴我們第四季度使用了 3000 萬美元的現金，也許可以告訴我您如何考慮 24 年每季的現金使用情況？

We've taken significant measures to reduce the cash utilization. In fact, despite the decline in COVID revenues across the industry in 2023, our cash utilization and '23 was actually less than it was in 2022. So as you mentioned, we've taken out $200 million out from our cost structure standpoint on an annualized basis. And going forward, we continue to remain very focused on strategies highlighted in our prepared remarks, and we'll continue to remain very judicious with where we deploy on our cash or continue to remain focused on decreasing cash utilization and increasing runway.

我們已採取重大措施來減少現金使用。事實上，儘管 2023 年整個產業的新冠疫情收入有所下降，但我們的現金利用率和 23 年實際上低於 2022 年。正如您所提到的，從成本結構的角度來看，我們已按年化支出 2 億美元。展望未來，我們將繼續非常關注我們準備好的演講中所強調的策略，我們將繼續對現金部署保持非常明智的態度，或繼續專注於減少現金利用率和增加跑道。

Okay. But no, no targets to provide us with?

好的。但沒有，沒有目標可以提供給我們嗎？

As we think about cash and go forward, et cetera. You know, as I said, we continue to decrease our cash utilization. All of the things I've mentioned in the past as well as we continue to evaluate opportunities and options to bolster our balance sheet.

當我們考慮現金並繼續前進時，等等。你知道，正如我所說，我們繼續減少現金利用率。我過去提到的所有事情以及我們繼續評估加強我們資產負債表的機會和選擇。

Okay. Thanks, guys. Appreciate the time.

好的。多謝你們。珍惜時間。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hello. This is Yuko on the call for Tejas. I apologize for earlier, we had some technical issues on our end. A couple of questions from me. Could you comment on your comfort with the pricing structure for both enterprise and consumer settings? And do you anticipate that current pricing for both the reader and the cartridges can still generate enough demand?

你好。我是 Yuko，正在為光輝號通話。我之前很抱歉，我們遇到了一些技術問題。我有幾個問題。您能否評估一下您對企業與消費者環境定價結構的滿意程度？您預計讀取器和墨盒的當前定價仍能產生足夠的需求嗎？

Yeah, the pricing we've adopted there, so there's a lot of factors that go into that. We look at demand, we look at also reimbursement. And if you look at the reader in particular, you mentioned that if you compare that to other laboratory analyzers in the point-of-care space, you're looking at a literal order of magnitude difference in the sort of cost to get the reader versus the laboratory analyzers that have similar capabilities so feel really good about the reader and the cost structure there.

是的，我們在那裡採用的定價，所以有很多因素影響。我們關注需求，也關注報銷。如果您特別關注閱讀器，您提到如果將其與床邊護理領域的其他實驗室分析儀進行比較，您會發現獲得閱讀器的成本存在字面上的數量級差異與具有類似功能的實驗室分析儀相比，因此對閱讀器和那裡的成本結構感覺非常好。

And there are various programs in both the consumer side and the point-of-care side that allow the customer to get the reader at no cost. And so really what we're our goal is to increase the installed base because as we've seen and as we mentioned for Q4, still a pull through on each install and in each reader that's in the field and so.

消費者端和護理點端都有各種程序，允許客戶免費獲得閱讀器。因此，我們的目標實際上是增加安裝基礎，因為正如我們所看到的以及我們在第四季度提到的那樣，每次安裝以及現場的每個讀者仍然會取得成功。

There is the dynamic with the reader as you want to get that out there and then you want to allow the customer to get value from that and continuing to purchase cartridges. And that dynamic will be even better with more menu. And so that's really why menu expansion is our number one priority because we want that installed base to pull through and get value out of a lot of additional menu items.

讀者之間存在動態關係，因為您希望將其發布，然後您希望讓客戶從中獲得價值並繼續購買墨盒。如果有更多選單，這種動態會更好。因此，這就是為什麼菜單擴充是我們的第一要務，因為我們希望安裝基礎能夠渡過難關，並從許多額外的菜單項目中獲得價值。

Got it. Thank you for that color. And also earlier this year, you made some changes to your Board of Directors and you also plan to add additional independent director to the Board in the future as well. Since the changes to the Board, should we anticipate any meaningful changes to your business strategy, whatever focus areas that are in discussion?

知道了。謝謝你的那個顏色。同樣在今年早些時候，您對董事會進行了一些調整，並且還計劃將來在董事會中增加更多的獨立董事。自董事會變動以來，無論討論的重點領域是什麼，我們是否應該預期您的業務策略會發生任何有意義的變化？

We announced a few weeks ago that we entered into the cooperation agreement with Tarsadia to add Board member, Rishi. And this is really so we can move forward in harmony with our shareholders and really incorporate their point of view, we feel good that those conversations are now behind us and Cue can execute on our strategy, I think, to show their commitment to working with our shareholders

幾週前，我們宣布與 Tarsadia 簽訂合作協議，增加董事會成員 Rishi。這確實是為了讓我們能夠與股東和諧相處，真正融入他們的觀點，我們很高興這些對話現在已經過去，我認為 Cue 可以執行我們的策略，以表明他們與合作的承諾我們的股東

One main agenda items that we've been hearing was the cost structure needs to come down, and we have been actively working on that last year. And as I mentioned in my prepared remarks that we have achieved over $200 million of cost reduction in the year.

我們聽到的一個主要議程項目是需要降低成本結構，去年我們一直在積極致力於這方面的工作。正如我在準備好的演講中提到的，我們今年已經實現了超過 2 億美元的成本削減。

So I think we're really executing on what our shareholders want to maximizing the shareholder value with our approach of lowering the cost, executing on menu expansion as our number one priority. So I think that what you've seen is that we've incorporated these strategies into our strategy as well.

因此，我認為我們確實是在執行股東的願望，透過降低成本的方法來最大化股東價值，將菜單擴展作為我們的首要任務。所以我認為你所看到的是我們也將這些策略納入了我們的策略中。

Thank you.

謝謝。

Thank you. This concludes today's conference call and thank you for participating. You may now disconnect.

謝謝。今天的電話會議到此結束，感謝您的參與。您現在可以斷開連線。