Cerus Corp (CERS) 2024 Q1 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation First Quarter 2024 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

女士們、先生們，大家好。感謝您的支持，歡迎參加 Cerus Corporation 2024 年第一季財報電話會議。 （操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to Jessica Hanover, Cerus Vice President of Corporate Affairs. Dr. Hanover, you may begin.

現在，我想將會議移交給 Cerus 公司事務副總裁 Jessica Hanover。漢諾威博士，您可以開始啦。

Thank you, and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.serus.com. With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Vivek Jayaraman, Cerus' Chief Operating Officer; Kevin Green, Cerus' Chief Financial Officer; and Carol Moore, Cerus' Senior Vice President of Regulatory Affairs and Quality.

謝謝，下午好。我想感謝大家今天的出席。作為今天網路直播的一部分，我們將同時顯示您可以關注的幻燈片。您可以從投資者關係網站 ir.serus.com 存取該投影片。與我一起參加電話會議的還有 Cerus 總裁兼執行長 Obi Greenman； Cerus 營運長 Vivek Jayaraman； Cerus 財務長 Kevin Green；以及 Cerus 監管事務和品質高級副總裁 Carol Moore。

Cerus issued a press release today announcing our financial results for the first quarter ended March 31, 2024, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.cerus.com.

Cerus 今天發布了一份新聞稿，宣布了我們截至 2024 年 3 月 31 日第一季的財務業績，並描述了該公司近期的業務亮點。您可以在公司網站 www.cerus.com 上存取此公告的副本。

I'd like to remind you that some of the statements we will make on this call related to future events and performance rather than historical facts and are forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2024 product revenue guidance, our expectations for operating cash flows and non-GAAP adjusted EBITDA performance and our expected expense levels, expected future growth and our growth trajectory, the availability and related timing of data from clinical trials, planned regulatory submissions and product launches, product expansion prospects and other statements that are not historical facts.

我想提醒大家，我們在本次電話會議上所做的一些陳述與未來事件和表現有關，而非歷史事實，是前瞻性陳述。前瞻性陳述的例子包括與我們未來財務和經營業績相關的陳述，包括我們對 2024 年產品收入的指引、我們對經營現金流量和非 GAAP 調整後 EBITDA 業績的預期以及我們預期的費用水平、預期的未來增長和我們的增長軌跡、臨床試驗數據的可用性和相關時間、計劃的監管提交和產品發布、產品的監管提交和其他歷史發布、產品的監管提交和產品的事實聲明。

These forward-looking statements involve risks and uncertainties that could cause actual events, performance and results to differ materially. They are identified and described in today's press release in our slide presentation and under Risk Factors in our Form 10-Q for the quarter ended March 31, 2024, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements.

這些前瞻性陳述涉及風險和不確定性，可能導致實際事件、表現和結果有重大差異。它們在我們今天的新聞稿中的幻燈片演示中以及我們將很快提交的截至 2024 年 3 月 31 日的季度 10-Q 表的風險因素下進行了識別和描述。我們不承擔更新前瞻性陳述的責任或義務。

On today's call, we will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For a reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures, please refer to today's press release and the slide presentation available on our website.

在今天的電話會議上，我們還將討論非 GAAP 財務指標，包括非 GAAP 調整後的 EBITDA。這些非 GAAP 指標應被視為依照 GAAP 提出的指標的補充，而不是替代。有關非公認會計準則財務指標與最具可比性的公認會計準則財務指標的對照表，請參閱今天的新聞稿和我們網站上的幻燈片簡報。

We'll begin today with opening remarks from Obi, followed by Vivek to discuss recent business highlights, then Kevin to review our financial results and expectations for the rest of 2024 and lastly, closing remarks from Obi.

今天，我們將以 Obi 的開場白開始，然後由 Vivek 討論近期的業務亮點，然後 Kevin 回顧我們的財務表現和 2024 年剩餘時間的預期，最後由 Obi 致閉幕詞。

And now it's my pleasure to introduce Obi Greenman, Cerus' President and Chief Executive Officer.

現在我很高興介紹 Cerus 總裁兼執行長 Obi Greenman。

Thank you, Jessica, and good afternoon, everyone. I'd like to open the call by spending a few minutes reviewing our recent positive performance as well as looking ahead of the key milestones on path for the company. The first quarter of 2024 was an important one in the history of the company as we reported positive top line results from the Phase III ReCePI clinical trial, the first of our 2 U.S. BARDA-funded trials for INTERCEPT red blood cells or RBCs.

謝謝你，潔西卡，大家下午好。在電話會議開始之前，我想花幾分鐘回顧我們最近的積極表現，並展望公司未來的關鍵里程碑。 2024 年第一季是公司歷史上重要的季度，因為我們報告了 III 期 ReCePI 臨床試驗的積極頂線結果，這是我們兩項由美國 BARDA 資助的 INTERCEPT 紅血球或紅血球試驗中的第一項。

We are thrilled that ReCePI met its primary efficacy endpoint of noninferiority of INTERCEPT RBCs compared to conventional RBCs in complex cardiovascular surgery patients. And while ReCePI was powered specifically for this primary efficacy endpoint, we are nonetheless also very pleased by the outcomes for the safety endpoints that we reported in March. We recognize that there is a great interest in the details of the ReCePI results, and we look forward to being able to share more by way of media presentations and journal publications targeted for later this year once the publications have been accepted.

我們很高興 ReCePI 達到了其主要療效終點，即在複雜心血管手術患者中，INTERCEPT RBC 與傳統 RBC 相比不劣於其他 RBC。雖然 ReCePI 專門針對這一主要功效終點進行研究，但我們對 3 月報告的安全終點結果感到非常滿意。我們認識到人們對 ReCePI 結果的細節非常感興趣，我們期待能夠透過媒體演示和期刊出版物分享更多信息，這些出版物計劃在今年晚些時候被接受後出版。

As we continue to enroll the RedeS study, our second U.S. BARDA-funded Phase III trial for INTERCEPT RBCs, we view the ReCePI readout as meaningful for the overall RBC program in supportive of our planned launch in Europe. We are looking forward to meeting with the ReCePI trial investigators next month to review the findings from the study and to gain their insights into the opportunities for how to position this important data set with the transfusion medicine community.

隨著我們繼續參與 RedeS 研究（這是我們第二次由美國 BARDA 資助的 INTERCEPT RBCs 第三階段試驗），我們認為 ReCePI 讀數對於整個 RBC 計劃具有重要意義，支持我們計劃在歐洲推出該項目。我們期待下個月與 ReCePI 試驗研究人員會面，審查研究結果，並了解他們如何將這一重要數據集定位於輸血醫學界的機會。

In summary, at this stage, the ReCePI data give us confidence in our INTERCEPT RBC program, and we look forward to sharing more with you in 2024. On the commercial front, we are increasingly confident in our expectations for 2024 and are reiterating our overall product revenue guidance of $172 million to $175 million, inclusive of our INTERCEPT Fibrinogen Complex guidance of $8 million to $10 million. Vivek will provide color into the continued traction we see across our portfolio and geographies. Importantly, we also remain committed adjusted EBITDA breakeven for the full year 2024. Kevin will provide more insight into our pathway for continued improvement in this metric over time.

總而言之，在現階段，ReCePI 數據讓我們對我們的 INTERCEPT RBC 計劃充滿信心，我們期待在 2024 年與您分享更多資訊。 Vivek 將為我們在投資組合和地區中看到的持續成長動能提供參考。重要的是，我們也將繼續致力於實現 2024 年全年調整後的 EBITDA 損益平衡。

I would like now to turn the call over to Vivek to discuss our commercial results and progress for the first quarter of 2024 as well as our outlook for the rest of the year.

現在，我想將電話轉給 Vivek，討論我們 2024 年第一季的商業成果和進展以及我們對今年剩餘時間的展望。

Thank you, Obi, and good afternoon to everyone. We continued our return to growth in Q1 2024. Across both product lines and geographic regions, we delivered strong performance in the quarter, and I am pleased with the collaboration and execution of the global commercial team. In the U.S., our core platelet franchise is stabilizing, and we witnessed a return to growth in our base U.S. business. Anecdotally, we are hearing from blood center customers that collections are slowly starting to recover and that platelet demand from their hospital customers remains strong.

謝謝你，奧比，祝大家下午好。我們在 2024 年第一季持續恢復成長。在美國，我們的核心血小板特許經營權正在趨於穩定，我們見證了美國基礎業務的恢復成長。據傳，我們從血液中心的客戶那裡聽說，收集量正在慢慢開始恢復，而且來自醫院客戶的血小板需求仍然強勁。

Furthermore, as we announced earlier, we received positive news from the FDA regarding our ability to increase platelet processing set shelf life. While our current forecast does not assume a major rebuilding of inventory at blood centers, the extended shelf life relieves a meaningful amount of pressure from our supply chain. As we work to further increase shelf life on a going-forward basis, we would expect to see the benefit across both inventory and service levels.

此外，正如我們之前宣布的那樣，我們從 FDA 收到了關於我們能夠延長血小板處理套件保質期的積極消息。雖然我們目前的預測並不認為血液中心會大規模重建庫存，但延長保質期可以減輕我們供應鏈的極大壓力。隨著我們努力進一步延長保質期，我們期望看到庫存和服務水準的雙重效益。

Turning to our efforts internationally. Our commercial team delivered a strong performance in the quarter, meeting the way was our continued progress in Canada in partnership with Canadian Blood Services or CBS. CBS is nearing full implementation of INTERCEPT platelets across their network and pathogen reduction is now the standard of care for platelet safety in Canada. The validation efforts at Hema-Quebec are also going well. As a reminder, the Canadian market is split roughly 80-20 between CBS and Hema-Quebec.

談到我們的國際努力。我們的商業團隊在本季表現強勁，並與加拿大血液服務中心 (CBS) 合作在加拿大繼續取得進展。 CBS 即將在其整個網路中全面實施 INTERCEPT 血小板，病原體減少現已成為加拿大血小板安全護理的標準。 Hema-Quebec 的驗證工作也進展順利。提醒一下，加拿大市場由 CBS 和 Hema-Quebec 兩家公司瓜分，份額約為 80-20。

Earlier in the quarter, I had the opportunity to attend the Annual MedLab Congress in Dubai. Of note, I was pleased to see the strong interest in INTERCEPT across the Middle East. This region is a targeted growth area for our franchise with a significant increase in health care investments in countries such as Saudi Arabia and a clinical focus on blood safety, we believe the Gulf region is an ideal area for market expansion. INTERCEPT is the only pathogen reduction system to be FDA approved and MDR cleared. We believe this regulatory distinction is a clear marker of advantage and really resonated with customers in the region. I'm encouraged by the ongoing cultivation of expansion prospects that will ensure growth for years to come.

本季早些時候，我有機會參加杜拜的年度 MedLab 大會。值得注意的是，我很高興看到中東地區對 INTERCEPT 的濃厚興趣。該地區是我們特許經營的目標成長區域，沙烏地阿拉伯等國家在醫療保健方面的投資大幅增加，臨床上註重血液安全，我們相信海灣地區是市場擴張的理想區域。 INTERCEPT 是唯一獲得 FDA 批准和 MDR 許可的病原體殺滅系統。我們相信，這種監管區別是一個明顯的優勢標誌，並且確實引起了該地區客戶的共鳴。我對持續培育擴張前景感到鼓舞，這將確保未來幾年的成長。

Our U.S. INTERCEPT Fibrinogen Complex, or IFC, delivered another strong quarter of growth in the period, and we feel confident in our ability to meet or exceed our full year revenue guidance for IFC. During the quarter, we hosted a Scientific Advisory Board meeting for IFC and the uptick in customer experience with and enthusiasm for the product was notable. We are beginning to see clear examples of peer-to-peer marketing on IFC, which is an effective tool for new product adoption.

我們的美國 INTERCEPT 纖維蛋白原複合物（IFC）在本季又實現了強勁的成長，我們有信心達到或超過 IFC 的全年營收預期。在本季度，我們為 IFC 主辦了一次科學顧問委員會會議，客戶對該產品的體驗和熱情顯著上升。我們開始看到 IFC 上點對點行銷的清晰例子，這是新產品採用的有效工具。

During the quarter, we continued our strong push at clinical conferences and saw an increase in lead generation and physician attendance at our symposium. As noted in prior calls, we are actively partnering with several large blood centers to enable them to offer IFC directly to their hospital customers, and we experienced a noted step-up in orders via the blood center channel. This is serving as a strong complement to our direct sales team who are now fully trained and are starting to see their hospital targets convert into ordering customers.

在本季度，我們繼續大力推動臨床會議，並看到研討會上的潛在客戶生成和醫生出席人數增加。正如先前的電話會議中所提到的，我們正在積極與幾家大型血液中心合作，使他們能夠直接向其醫院客戶提供 IFC，並且我們透過血液中心管道的訂單量明顯增加。這對我們的直銷團隊起到了強有力的補充作用，我們的直銷團隊現在已經過全面培訓，並開始看到他們的醫院目標轉化為訂購客戶。

Most importantly, we continue to receive strong clinical support for the utility of biopsy and for the patient benefit associated with earlier access to fibrinogen. I look forward to providing more updates on our progress with IFC as well as our global commercial progress overall during future calls.

最重要的是，我們繼續獲得強有力的臨床支持，以支持活檢的實用性以及早期獲取纖維蛋白原給患者帶來的益處。我期待在未來的電話會議中提供更多有關我們與 IFC 的進展以及我們全球商業進展的最新資訊。

I will now turn the call over to Kevin to review our financial results.

現在我將把電話轉給凱文來審查我們的財務結果。

Thanks, Vivek. Good afternoon, and thank you all for joining us today. On today's call, I'll be discussing our financial results for the first quarter of 2024, highlighting the progress we made on the top line, the bottom line and the balance sheet. I'll also be providing some commentary on our positive financial outlook for the rest of the year.

謝謝，維韋克。下午好，感謝大家今天的出席。在今天的電話會議上，我將討論我們 2024 年第一季的財務業績，重點介紹我們在營收、淨利和資產負債表方面取得的進展。我也會對我們今年剩餘時間的正面財務前景發表一些評論。

To start, we posted product revenue of $38.4 million for the first quarter of 2024. This represents year-over-year growth of 24%, demonstrative of a strong underlying growth in the business and ahead of our Q1 guidance provided back in January. North American platelet sales were the major contributor to our product revenue growth during the quarter. In the U.S., first quarter 2024 product revenues exceeded prior year levels by more than 40%. As we anticipated, sales in Canada to Canadian Blood Services were also extremely strong and are now approaching nearly 100% adoption across their entire platelet production operations.

首先，我們公佈的 2024 年第一季產品收入為 3,840 萬美元。北美血小板銷售是我們本季產品收入成長的主要貢獻者。在美國，2024 年第一季的產品收入比去年同期成長了 40% 以上。正如我們預期的那樣，加拿大血液服務中心的銷售也非常強勁，目前其整個血小板生產業務的採用率已接近 100％。

In EMEA, first quarter product revenues were down 9% year-over-year and 8% compared to the fourth quarter of 2023. Certain delays and timing of order fulfillment primarily drove the decline, which is expected to reverse itself over the succeeding quarters. Year-over-year, FX rates provided a benefit for the EMEA business of around 1.1%. On a consolidated basis, FX provided a benefit of around 50 basis points when comparing Q1 [2023].

在 EMEA 地區，第一季產品收入年減 9%，環比下降 8%。與去年同期相比，外匯匯率為 EMEA 業務帶來了約 1.1% 的收益。從合併基礎來看，與 2023 年第一季相比，外匯帶來了約 50 個基點的收益。

As we mentioned on our last quarterly call, we are providing a quarterly breakout of IFC product revenue. For Q1, we posted IFC revenue of $1.9 million, driven by increasing contributions from our national sales agreements with large U.S. blood center partners. As mentioned by Vivek, we believe the expanding recognition of IFC's clinical and operational utility will continue to drive the growth going forward.

正如我們在上次季度電話會議上提到的那樣，我們正在提供 IFC 產品收入的季度明細。第一季度，我們的 IFC 收入為 190 萬美元，這得益於我們與美國大型血液中心合作夥伴簽訂的全國銷售協議的貢獻不斷增加。正如 Vivek 所說，我們相信，IFC 的臨床和營運效用的認可度不斷提高，將繼續推動其未來的成長。

In addition to our product revenue and not included in our guidance, government contract revenue totaled $5 million in Q1 compared to $7.5 million for the prior year period. The completion of our U.S. Phase III ReCePI clinical trial was the primary driver for the decline. We expect this factor will result in government contract revenue remaining near Q1 levels until such time as our Turkish site begins enrollment for the RedeS trial. To remind you, included in our government contract revenue are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further hold blood pathogen reduction and our milestone-based agreement with the U.S. Department of Defense for lyophilized IFC.

除了我們的產品收入（未包含在我們的指導範圍內）之外，第一季的政府合約收入總計 500 萬美元，而去年同期為 750 萬美元。我們在美國 III 期 ReCePI 臨床試驗的完成是導致下降的主要原因。我們預計，這一因素將導致政府合約收入保持在第一季的水平附近，直到我們的土耳其站點開始招募 RedeS 試驗。提醒您，我們的政府合約收入包括根據我們與BARDA簽訂的合約、與FDA簽訂的進一步保持血液病原體減少的協議以及我們與美國國防部簽訂的凍乾IFC的里程碑協議確認的報銷收入。

Let's now turn to our product gross profit and gross margins. Our first quarter product gross profit was $21.3 million compared to $17.3 million during the prior year period, an increase of 23% year-over-year. Product gross margins for the first quarter were 55.4%, relatively stable when compared to the prior year and Q4 2023. These results were consistent with our previously announced expectations and we continue to believe that we will achieve relative consistency in our gross margins this year.

現在讓我們來談談我們的產品毛利和毛利率。我們第一季的產品毛利為 2,130 萬美元，去年同期為 1,730 萬美元，較去年同期成長 23%。第一季的產品毛利率為55.4%，與去年同期和2023年第四季相比相對穩定。

Moving on. Our first quarter operating expenses, which totaled $34.3 million were $4.6 million lower than the prior year period of $38.9 million, a year-over-year decline of 12%. Q1 2024 operating expenses included $5.9 million in noncash stock-based compensation. By specific expense type, first quarter R&D expenses totaled $14.5 million compared to $17.4 million during the prior year period. This 17% decline was driven primarily by the completion of the ReCePI clinical trial and the effects of the restructuring implemented in June of last year.

繼續。我們第一季的營運費用總計 3,430 萬美元，比去年同期的 3,890 萬美元下降 460 萬美元，年減 12%。 2024 年第一季的營運費用包括 590 萬美元的非現金股票薪酬。以具體費用類型劃分，第一季研發費用總計 1,450 萬美元，去年同期為 1,740 萬美元。 17%的下降主要是由於ReCePI臨床試驗的完成以及去年6月實施的重組的影響。

First quarter SG&A expenses were $19.8 million compared to $21.6 million during the prior year period. The decline again driven by last year's restructuring. We believe this level of SG&A expense is sustainable for the remainder of 2024 and will allow us to drive our expected growth and to deliver against our revenue expectations.

第一季銷售、一般及行政開支為 1,980 萬美元，去年同期為 2,160 萬美元。此次下滑再次受到去年重組的影響。我們相信，這一水準的銷售、一般及行政費用在 2024 年剩餘時間內是可持續的，並將使我們能夠推動預期的成長並實現我們的收入預期。

Let's now focus on the bottom line and non-GAAP adjusted EBITDA results. On the bottom line, reported net loss attributable to Cerus for the 3 months ended March 31, 2024, improved significantly when compared to the same period in the prior year. Net loss attributable to Cerus for Q1 narrowed by 38% to $9.7 million or $0.05 per diluted share compared to $15.6 million or $0.09 per diluted share for the prior year period.

現在讓我們專注於底線和非 GAAP 調整後的 EBITDA 結果。重點是，截至 2024 年 3 月 31 日的 3 個月內，歸屬於 Cerus 的報告淨虧損與去年同期相比顯著改善。第一季歸屬於 Cerus 的淨虧損為 970 萬美元或每股攤薄虧損 0.05 美元，而去年同期的淨虧損為 1,560 萬美元或每股攤薄虧損 0.09 美元，下降了 38%。

On a non-GAAP adjusted EBITDA basis, Q1 2024 generated a much narrower loss of $2.7 million compared to a loss of $9.8 million for the prior year period. As we look ahead to the balance of the year, we expect that as we deliver the top line growth in our guidance and maintain stable gross margins and operating expenses, we expect to achieve at least breakeven non-GAAP adjusted EBITDA for 2024 as a whole.

以非 GAAP 調整後的 EBITDA 計算，2024 年第一季的虧損為 270 萬美元，遠低於去年同期的 980 萬美元虧損。展望今年的剩餘時間，我們預計，隨著我們實現指引中的營收成長並保持穩定的毛利率和營運費用，我們預計 2024 年全年至少實現盈虧平衡的非 GAAP 調整後 EBITDA。

On the balance sheet and associated cash flows, we ended the first quarter with a cash position of $72.2 million of cash, cash equivalents and short-term investments on the balance sheet. Importantly, as we previously announced was a possibility, we generated positive operating cash flows of $2 million for the first quarter compared to cash used from operations of $8.5 million during the prior year period. With our expected top line growth and anticipated declining inventory levels for the remainder of 2024, we continue to believe that with some possible quarterly fluctuations, we can potentially generate positive operating cash flows for 2024 as a whole.

在資產負債表和相關現金流量方面，我們在第一季結束時的資產負債表上的現金、現金等價物和短期投資狀況為 7,220 萬美元。重要的是，正如我們之前宣布的那樣，我們第一季產生了 200 萬美元的正營運現金流，而去年同期的營運現金流為 850 萬美元。由於我們預計 2024 年剩餘時間的營收將成長，且庫存水準將下降，我們仍然相信，儘管可能出現一些季度波動，但我們有可能在 2024 年全年產生正的經營現金流。

Turning now to our guidance. As Obi mentioned, we are increasingly confident in our growth expectations. And as such, we are reiterating our full year 2024 product revenue guidance in the range of $172 million to $175 million, reflecting double-digit growth from last year. As we stated previously, we anticipate this growth to be fueled by the continued expansion of the INTERCEPT platelet business, both in North America and in Europe as well as continued uptake of IFC in the U.S. We are also reiterating our full year 2024 revenue guidance for IFC, which we continue to expect to be in the range of $8 million to $10 million, representing growth of roughly 25% to 50% for 2023 IFC sales.

現在來談談我們的指導。正如奧比所說，我們對我們的成長預期越來越有信心。因此，我們重申 2024 年全年產品營收預期，即 1.72 億美元至 1.75 億美元，較去年實現兩位數成長。正如我們之前所說，我們預計這一增長將受到 INTERCEPT 血小板業務在北美和歐洲的持續擴張以及美國對 IFC 的持續吸收的推動。

I'd now like to turn the call back over to Obi for some closing remarks.

現在我想將電話轉回給奧比，請他做一些結束語。

Thank you, Kevin. We are pleased with our momentum from the start of 2024, and we expect to see it carried through the rest of the year. The company is making strong progress towards our commercial pipeline and financial goals, allowing us to expand the access to and applicability of the INTERCEPT Blood System on a global basis. Thank you for your continued interest in Cerus.

謝謝你，凱文。我們對 2024 年初以來的發展勢頭感到滿意，並希望這種勢頭能夠持續到今年剩餘時間。公司在商業管道和財務目標方面正在取得重大進展，這使我們能夠在全球範圍內擴大 INTERCEPT 血液系統的使用範圍和適用性。感謝您對 Cerus 的持續關注。

I will now turn the call over to the operator for questions.

我現在將把電話轉給接線員來回答問題。

(Operator Instructions). Our first question comes from Joshua Jennings with TD Cowen.

（操作員指令）。我們的第一個問題來自 TD Cowen 的 Joshua Jennings。

This is Eric on for Josh. I wanted to just start with guidance. I appreciate the commentary that you provided there for 2024. I was hoping to just hear a little bit more about the cadence of revenue growth that you would expect to deliver through the remainder of this year?

這是 Eric 代替 Josh 發言。我只是想提供指導。我很感謝您對 2024 年所做的評論。

Yes. Thanks a lot, Eric. Vivek, would you like to take that question?

是的。非常感謝，埃里克。 Vivek，您願意回答這個問題嗎？

Sure, I'd be happy to. We're pleased with the performance in Q1. As you'll note, and you probably recall, Q1 of 2023 was sort of artificially low given some onetime issues that we were dealing with respect to dating and then also some issues internationally. So we anticipated a fairly solid bounce back in Q1, but as our full year guidance suggests, we believe in our ability to deliver double-digit growth throughout the balance of the year.

當然，我很樂意。我們對第一季的表現感到滿意。正如您所注意到的，而且您可能還記得，由於我們在約會方面處理的一些一次性問題以及一些國際問題，2023 年第一季的銷售額有點人為地低。因此，我們預計第一季將出現相當強勁的反彈，但正如我們的全年指引所示，我們相信我們有能力在全年實現兩位數的成長。

And so Q1, both from a core product line standpoint as well as our IFC franchise were solid results, and we anticipate continuing to deliver that sort of growth, at least in the double-digit percentage throughout the balance of 2024. So that's currently are out for the year.

因此，無論從核心產品線的角度還是從我們的 IFC 特許經營權的角度來看，第一季的業績都穩健，我們預計將繼續實現這種增長，至少在 2024 年全年保持兩位數的增長。 所以目前這是今年的預期。

That's great. And then on the shelf life extension, I know it was on the March that you received a 12-month shelf life approval. But have you and your customers already started to see some of the benefits of that extended life or is that something that might take a few quarters to have a real impact here?

那太棒了。關於延長保質期，我知道你們在三月獲得了 12 個月保質期的批准。但是您和您的客戶是否已經開始看到延長使用壽命帶來的一些好處，或者這是否可能需要幾個季度才能產生真正的影響？

Yes. Thanks again for the question, Eric. And Vivek, I think it's right up your alley to take as well.

是的。再次感謝您的提問，艾瑞克。還有 Vivek，我覺得這也很適合你。

Sure. Yes, I'd be happy to. As you probably are aware, there's a little bit of time involved in terms of being able to flow those changes through our manufacturing process and get that new product out. We are able to utilize that dating for product that's already in the field. So that relieve some of the pressure on our supply chain and mitigate some of the risk of product obsoleting on customer shelves. So that's certainly a benefit.

當然。是的，我很樂意。您可能已經知道，將這些變化融入我們的製造流程並推出新產品需要一點時間。我們能夠利用該日期來測定已在現場的產品。這樣可以減輕我們供應鏈的一些壓力，並降低客戶貨架上產品過時的風險。這當然是有好處的。

But as I indicated earlier, our current forecast doesn't assume a material rebuild of inventory at the customer level. Certainly, as customers get accustomed to longer shelf life, they may feel like they want to rebuild their inventory levels and hold more products at their locations. But I think the relief on the supply chain and sort of avoidance of any acute obsolescence issues or something that certainly benefited customers, and we've heard positive feedback about that.

但正如我之前指出的那樣，我們目前的預測並不假設客戶層面的庫存實質重建。當然，隨著客戶習慣了更長的保質期，他們可能會想要重建庫存水準並在其所在地存放更多產品。但我認為這對供應鏈的緩解以及避免任何嚴重的過時問題或其他問題肯定對客戶有益，我們也聽到了正面的回饋。

Our next question comes from Matt Blackman with Stifel.

下一個問題來自 Stifel 的 Matt Blackman。

This is Emily on for Matt. Just a couple of questions for me on the international business, the weakness there. Just if you could give any additional color if it was certain markets or related to any of the geopolitical things that are happening. Just a little bit more color there, if you could?

這是艾米麗 (Emily) 為馬特 (Matt) 主持的。我只想問幾個關於國際業務及其弱點的問題。如果您可以提供任何額外的信息，如果它涉及某些市場或與正在發生的任何地緣政治事件相關的話。如果可以的話，請再添加一點顏色，好嗎？

Yes. Thanks a lot, Emily. I think Kevin has some thoughts on that.

是的。非常感謝，艾米麗。我認為凱文對此有一些想法。

Yes. I think it really is, as we mentioned in the prepared remarks, more of a timing issue than anything. I don't think there's any fundamental weakness in the overseas market. In fact, as we indicated in the prepared remarks, we expect that it will rebound after these timing issues and order patterns for the balance of the year, and we expect growth coming out of EMEA as well as the U.S. So it sometimes happens with distributor orders or other factors where there's a timing issue, and I think that's what was at play here.

是的。我認為，正如我們在準備好的發言中所提到的那樣，這更多的是一個時機問題。我認為海外市場不存在任何根本的弱點。事實上，正如我們在準備好的評論中所指出的那樣，我們預計在解決這些時間問題和今年餘下的訂單模式之後，銷售額將出現反彈，我們預計歐洲、中東和非洲地區以及美國都將實現增長。

Okay. Great. And then if you could just give us an update on the regulatory progress in China at this time?

好的。偉大的。那麼您能否向我們介紹一下目前中國監管的進展？

Yes. Thanks, Emily. So we have the planet file under review by the NMPA. There obviously a lot of Chinese holidays over the last couple of months. So we're still awaiting any additional questions that they may have. We expect those questions in the second quarter here. And then with those questions, we'll be able to provide a lot more clarity around the likely timing for an approval.

是的。謝謝，艾米麗。因此，我們的行星文件正在接受 NMPA 的審查。過去幾個月裡，中國假期顯然很多。因此我們仍在等待他們可能提出的任何其他問題。我們預計這些問題將在第二季出現。透過這些問題，我們將能夠更清楚地了解批准的可能時間。

Our next question comes from Jacob Johnson with Stephens.

我們的下一個問題來自史蒂芬斯的雅各布·約翰遜。

Maybe for Obi for Kevin on guidance. I heard that just say kind of double-digit growth for the balance of the year. I run that through my Excel spreadsheet. I get something towards the higher end of the guidance, Obi you said in the release, increasingly confident in the guidance this year. I understand we're just a quarter in, but fair to say kind of expectations now versus the beginning of the year, you're trending maybe towards the higher end of the guidance? And Kevin, maybe any words of caution from a CFO?

也許是奧比 (Obi) 為凱文 (Kevin) 提供指導。我聽說今年的餘額將實現兩位數的成長。我透過 Excel 電子表格來運行它。奧比，你在記者會上說，我得到一些接近指導上限的數據，對今年的指導越來越有信心。我知道我們才剛進入一個季度，但公平地說，與年初相比，現在的預期可能趨向於預期的高端？凱文，財務長能否給予一些警告？

Give me a little kick on the table. I think we're very optimistic about the growth trajectory for the year. We'd like to sort of get Q2 under our belt just to see how things play out. As Vivek mentioned as well, there's really not a lot factored in at the moment for the extension of the shelf life and any kind of restocking opportunities. So that's sort of the logic behind maintenance of guidance at this time.

在我桌上輕輕踢一下。我認為我們對今年的成長軌跡非常樂觀。我們想透過第二季的經驗來觀察事情的進展。正如 Vivek 所提到的，目前對於延長保質期和任何補貨機會的考慮還不夠多。這就是目前維持指導背後的邏輯。

Yes. I mean from my perspective, Jacob, I think that's absolutely right. We don't know what FX rates are going to do. So there's potential downside from that. But I think fundamentally, we are more confident as we sit here today than we were in January when we provided the initial guidance. And as things unfold, we'll be in a better position to provide up to you all.

是的。我的意思是，從我的角度來看，雅各布，我認為這是完全正確的。我們不知道外匯匯率將會如何變動。因此，這存在潛在的負面影響。但我認為，從根本上來說，我們今天在這裡比一月份提供初步指引時更有信心。隨著事態的發展，我們將能夠更好地為大家提供服務。

Got it. I just figured I had to try. And then maybe for Vivek. Just on the IFC growth, it sounds like maybe some traction with some of the larger blood centers you partnered with. I'm just kind of curious on the IFC side of things, kind of trends on those blood centers you partnered with versus some of the manufacturing partners you have on the IFC side of things?

知道了。我只是認為我必須嘗試一下。然後也許是 Vivek。僅就 IFC 的增長而言，聽起來好像與您合作的一些較大的血液中心有一些聯繫。我只是對 IFC 方面的事情感到好奇，您合作的血液中心與 IFC 方面的一些製造合作夥伴之間的趨勢如何？

Yes, happy to address that. Thanks for the question. If I think about our IFC business, and I think as we stated earlier, coming out of Q1, we feel even more confident about our ability to deliver against the annual guidance and see strong growth in that franchise. And there are really a few reasons for our sort of increased confidence. The first, we announced late last year that we had formed partnerships with large blood centers for them to distribute IFC directly to their hospital customers. And in Q1, we saw a material step-up in terms of blood center customers who are ordering IFC directly through that channel. So it was good initial validation of the strength of that channel and our ability to broaden access to IFC.

是的，很高興解決這個問題。謝謝你的提問。如果我考慮我們的 IFC 業務，我想正如我們之前所說的那樣，從第一季度開始，我們對實現年度指導目標的能力以及看到該特許經營的強勁增長更加有信心。我們的信心增強確實有幾個原因。首先，我們在去年年底宣布，我們已經與大型血液中心建立合作夥伴關係，以便他們將 IFC 直接分發給他們的醫院客戶。在第一季度，我們看到透過該管道直接訂購 IFC 的血液中心客戶數量大幅增加。因此，這是對該通路實力和我們擴大 IFC 通路能力的良好初步驗證。

The second sort of area of encouragement for us was in the account that we had opened up in late 2023, we saw a pretty significant increase in use ad accounts sort of same-store sales. We may have entered initially and through one clinical department. Perhaps it was high risk or trauma. And what we saw was a broadening out across that institution of availability of IFC as the clinicians start to engage with one another and they sort of saw firsthand the benefit of having that product available. So that's encouraging to you because it shows that not only can we get access to more hospitals, but once we get in, we have the ability to go deeper within those accounts.

對我們來說，第二個令人鼓舞的領域是我們在 2023 年底開設的帳戶，我們發現使用廣告帳戶的同店銷售額有相當顯著的成長。我們可能最初是透過一個臨床部門進入的。也許是高風險或創傷。我們看到，隨著臨床醫生開始相互交流，IFC 的可用性在整個機構內不斷擴大，他們親眼目睹了使用產品的好處。這對你們來說是令人鼓舞的，因為這表明我們不僅可以進入更多的醫院，而且一旦我們進入，我們就有能力深入了解這些帳戶。

And then lastly, with our manufacturing partners, which you referenced, we have sufficient manufacturing capacity in 2024 to meet or exceed our guidance. What we're doing is we're working actively to increase capacity because we want to make sure that as we generate demand, we have supply available to meet it. So similar to what Kevin said about overall product guidance for 2024, specifically to IFC guidance for the calendar year, we feel much better about things here in early May than we did back in January when we issued that guidance. And so that's certainly a positive progress.

最後，正如您所提到的，透過與我們的製造合作夥伴合作，我們在 2024 年擁有足夠的製造能力來達到或超越我們的預期。我們正在積極努力地提高產能，因為我們希望確保在產生需求時，有足夠的供應來滿足需求。因此，與 Kevin 所說的 2024 年整體產品指導（特別是 IFC 對日曆年的指導）類似，我們對 5 月初的情況感覺比 1 月份發布該指導時好得多。這無疑是一個積極的進展。

Got it. That's helpful. And if I could just sneak in one more, sorry to keep you on the hot seat, Vivek. But just on the Middle East opportunity, it sounds like there's an opportunity in that region. I'm just kind of curious are there any areas you need to invest? Or are there any kind of hoops you need to jump through to kind of better realize that opportunity as we start thinking about that?

知道了。這很有幫助。如果我可以再偷偷說一句，很抱歉讓你陷入困境，維維克。但僅就中東的機會而言，聽起來該地區有機會。我只是有點好奇您是否需要投資哪些領域？或者，當我們開始考慮這個問題時，您需要克服哪些困難才能更好地抓住這個機會？

Yes. Great question. Thanks. As I mentioned, the opportunity to spend some time in the region at the annual MedLab Conference, which was held in Dubai. And candidly, the most challenging hoops to jump through are ones that we've already cleared and that's receiving both FDA approval and MDR clearance. I'm sure you hear a lot about the onerous nature of the MDD to MDR transition and the fact that we have achieved that milestone and in addition to the fact that we're the only pathogen reduced technology that has an FDA approval, that really resonates with customers in that region.

是的。好問題。謝謝。正如我所提到的，有機會在杜拜舉行的年度 MedLab 會議上花一些時間在該地區。坦白說，最難突破的障礙是我們已經通過的障礙，即獲得 FDA 批准和 MDR 許可。我相信您已經聽說過很多有關 MDD 到 MDR 轉變的繁重性質的消息，而我們已經實現了這一里程碑，此外，我們是唯一獲得 FDA 批准的病原體減少技術，這確實引起了該地區客戶的共鳴。

They tend to take their cues from the AABB and look to the U.S. in terms of technology adoption. So that's sort of the major driver of the community and market interest there. It also is tied to an overall -- as you're probably aware of investment strategy in Saudi in particular, where they recognize there's a -- sort of a defined runway in terms of their economy being driven by natural resources. So they're investing in health care, they're investing in entertainment and the rest. So there's a big push to invest in health care, and there's a view to what technologies are approved in the U.S. and MDR cleared as things that they want to bring in locally. And so those are some of the factors that accrue to our benefit when we think about growth in that region.

他們傾向於聽取 AABB 的建議並在技術採用方面向美國學習。所以這可以說是當地社區和市場興趣的主要驅動力。這也與整體投資策略相關——您可能特別了解沙烏地阿拉伯的投資策略，他們意識到，他們的經濟由自然資源驅動，存在著明確的發展路徑。所以他們投資醫療保健、投資娛樂和其他領域。因此，他們大力推動對醫療保健的投資，並考慮將哪些技術在美國獲得批准和MDR批准，作為他們希望引入本地的技術。所以當我們考慮該地區的發展時，這些就是對我們有利的一些因素。

Our next question comes from Ross Osborn with Cantor Fitzgerald.

下一個問題來自 Cantor Fitzgerald 的 Ross Osborn。

Congrats on the progress. So starting off, will you discuss how reimbursement has gone with IFC in terms of accounts being able to receive an NTAP?

祝賀你取得進展。那麼首先，您能討論一下就能夠收到 NTAP 的帳戶而言，IFC 的報銷情況如何嗎？

Thanks, Ross. I think your voice broke up a little bit, at least on our end. So I think your question was around reimbursement for IFC and the evolution there linked to the NTAP, is that correct?

謝謝，羅斯。我覺得你的聲音有點哽咽，至少在我們這邊是這樣的。所以我認為您的問題是關於 IFC 的償還以及與 NTAP 相關的發展，對嗎？

Yes, that's correct.

是的，正確。

Okay. Great. Thanks, Ross. Vivek, sorry to put you on this, ask it again, but could you address that?

好的。偉大的。謝謝，羅斯。 Vivek，很抱歉讓您遇到這個問題，請再問一遍，您能解決這個問題嗎？

I can't get the question, you broke up a little bit.

我不明白這個問題，你們有點分手了。

Yes, it's basically around how the reimbursement evolution for IFC has occurred in the context of the NTAP. So really, how does IFC reimbursement take place at the hospital level?

是的，這基本上是圍繞著在 NTAP 背景下 IFC 的償還演變過程。那麼，IFC 的報銷在醫院層級實際上是如何進行的呢？

(technical difficulty) and it allows us to do initially getting the NTAP designation as it created more awareness and interest from clinicians. But fundamentally, the way in which products paid for us through the -- depending upon the case through the associated DRG. So what we've been able to see, which has been encouraging is initially, we thought we'd get quite a bit of pushback on price and cost.

（技術難度）它使我們最初獲得 NTAP 稱號，因為它引起了更多臨床醫生的關注和興趣。但從根本上來說，產品支付給我們的方式是透過——取決於具體情況，透過相關的 DRG 支付。因此，我們能夠看到的是令人鼓舞的是，我們最初以為我們會在價格和成本上遭遇相當大的阻力。

And once we get through the value added thing, the value analysis committees or in the case of leveraging the blood center relationship with the hospital and going through that channel, we've actually seen much less pushback on price than we'd anticipated. So we're going to have to track that on an ongoing basis now so we have to continue to prove the clinical utility. But that hasn't been a governor in terms of getting new accounts on board. It's really been just getting through the process of getting new products into an institution if we're selling directly and then getting the blood center channel up and trained if we were going through that channel partner.

一旦我們完成了增值工作、價值分析委員會或利用血液中心與醫院的關係並通過該管道，我們實際上看到的價格阻力比我們預期的要小得多。所以我們現在必須持續追蹤這一點，以便我們必須繼續證明其臨床效用。但這對於獲取新帳戶來說並不是一個好辦法。如果我們直接銷售，這實際上只是將新產品送達機構的過程；如果我們透過通路合作夥伴銷售，這實際上只是將血液中心管道建立起來並進行培訓的過程。

Yes. I'd add that the value proposition around the timely availability of the product to the patient really seems to resonate over time as does the dramatic reduction in wastage that we're seeing at the hospitals that have taken on IFC.

是的。我想補充一點，隨著時間的推移，及時向患者提供產品的價值主張似乎確實產生了共鳴，正如我們在採用 IFC 的醫院中看到的浪費大幅減少一樣。

Great. And then lastly and looking at the smaller geographies for those that could provide some upside. Could you discuss the state of the U.K. and Germany?

偉大的。最後，讓我們來看看那些可能帶來一些好處的小地區。您能討論一下英國和德國的現況嗎？

Yes, I'll start there, and maybe I'll take U.K. and Vivek can take Germany. So the U.K. has been a long story as a lot of these accounts that are sort of deferring the decision around improving the safety and availability of the blood supply. That's an increasingly sort of challenging position to take when so many other countries have established pathogen activation and INTERCEPT specifically as the standard of care and the results that they're seeing from real-world experience with the product.

是的，我會從那裡開始，也許我會選擇英國，而 Vivek 可以選擇德國。因此，英國的情況一直很糟糕，因為許多帳戶都在推遲有關改善血液供應安全性和可用性的決定。當許多其他國家已將病原體活化和 INTERCEPT 確立為治療標準，並且從產品的實際經驗中看到了效果時，採取這一立場就變得越來越具有挑戰性。

The U.K. is about ready to release a report on blood safety coming from the HIV and hepatitis epidemics of the '80s and '90s. It's called the infected blood inquiry. That's supposed to be published on May 20 in the U.K., and it's estimated that there'll be multibillion-dollar restitutions to the victims. So I think that will have some impact on sort of how the U.K. looks at blood safety and availability going forward.

英國即將發布一份有關 1980 年代和 1990 年代愛滋病和肝炎流行的血液安全報告。這被稱為感染血液調查。該法案預計將於 5 月 20 日在英國公佈，預計受害者賠償金額將達數十億美元。所以我認為這會對英國未來對血液安全和供應的看法產生一定影響。

That being said, it's a single payer system, as you know. And so the national health service, blood and tissue has a fairly formal process for how they would take on pathogen activation. But we're optimistic that at some point in time, that market will convert. It's just hard to predict when, Vivek, do you mind covering on Germany?

話雖如此，如你所知，這是一個單一付款人系統。因此，國家衛生服務、血液和組織部門對於如何應對病原體活化有一個相當正式的流程。但我們樂觀地認為，在某個時間點，這個市場將會轉變。只是很難預測，維韋克，你介意什麼時候報道德國的情況嗎？

Sure. I'd be happy to. For Germany, if you think about the market dynamics that's more similar to the U.S. as opposed to situation in France where you have a single decision maker. And once they decide to go, it really becomes about partnering with them from an operations standpoint around implementation. So we are actively involved in continue in Germany with getting accounts online, working with them to get their MAA and ML and marketing license approvals and what's been most encouraging is we're starting to get some institutions to start Berlin. We put about Berlin Charite hospital beginning with pathogen reduction. That's one of the top 10 leading hospitals in the world.

當然。我很樂意這麼做。對於德國，如果你考慮市場動態，它與美國更相似，而不是像法國那樣只有一個決策者。一旦他們決定行動，我們就需要在實施過程中從營運的角度與他們建立合作關係。因此，我們積極參與在德國繼續進行線上帳戶的工作，與他們合作獲取 MAA 和 ML 以及行銷許可證批准，最令人鼓舞的是，我們開始讓一些機構在柏林開展業務。我們從減少病原體開始談柏林夏利特醫院。這是世界十大頂尖醫院之一。

And so you get these luminary institutions on board, and that's kind of where we see progress driving. So the German Red Cross GRK is also the other area of customers where we're working towards getting them up on pathogen reduction. One of the things that we'll need to work through is getting an extended day label claim like a 6-day claim in the marketplace. But in terms of where we stand now, Germany continues to be a growth opportunity for us in EMEA. We've got a direct team on the ground there, and we're starting to see product adoption. So it's a slower process, like I said, in some geographies where you have a single decision maker. But on balance, we feel good about our growth prospects for Germany through the balance of the decade.

因此，您得到了這些傑出機構的參與，這就是我們看到的進步的推動力。因此，德國紅十字會 GRK 也是我們致力於幫助其減少病原體的另一個客戶區域。我們需要解決的問題之一是在市場上獲得延長日標籤聲明，例如 6 天聲明。但就我們目前的狀況而言，德國仍然是我們在歐洲、中東和非洲地區成長的機會。我們在當地有一個直接團隊，我們開始看到產品的採用。所以就像我說的，在一些只有一個決策者的地區，這個過程比較慢。但總體而言，我們對德國未來十年的成長前景感到樂觀。

(Operator Instructions) Our next question comes from William Bonello with Craig-Hallum Capital Group.

（操作員指示）我們的下一個問題來自 Craig-Hallum Capital Group 的 William Bonello。

Obviously, great recovery in North America. Just trying to understand a little bit more about EMEA outside North America. I get the quarter and what you said there. But just more generally, I mean, it's been sort of a several year trend of sort of declining revenue. What's sort of the underlying dynamic that's happening there? And how does that change? Does it only change by more countries coming on board? Are you pretty much not expecting growth where you already are? Or how do we think about that?

顯然，北美出現了巨大的復甦。只是想多了解一點北美以外的 EMEA 地區的情況。我明白了，也明白你所說的內容。但更普遍地說，我的意思是，收入已經連續幾年呈現下降趨勢。那裡正在發生什麼樣的潛在動態？那會如何改變呢？是否只有隨著更多國家的加入，這種情況才會改變？您是否幾乎不期望在現有的基礎上實現成長？或者我們該如何看待這個問題？

Well, I think last year was somewhat of an anomaly that we traditionally see sort of single digit or low single-digit organic growth in markets where we have 100% penetration, for example, in France and Belgium. And last year, we don't know if it was a function of sort of COVID or just change in transfusion practices around transfusion thresholds for platelets, but we saw a decline last year in the organic growth in the overall platelet demand in those markets.

嗯，我認為去年的情況有些異常，在我們已經實現 100% 滲透率的市場，例如法國和比利時，我們通常會看到個位數或低個位數的有機成長。去年，我們不知道這是否是 COVID 的影響，還是只是圍繞血小板輸血閾值的輸血實踐的改變，但我們看到去年這些市場整體血小板需求的有機增長有所下降。

That's recovered this year, as we mentioned in our prepared remarks. I think as far as longer-term growth trajectory, it really is about new geographies as well as ultimately having some growth in the plasma business, which has been lagging the platelet adoption. So I think we feel pretty confident about the geographic opportunities for us in Europe. And that being said, it's really hard to predict exactly when these large accounts will come online. So I don't know if that answers your question, Bill?

正如我們在準備好的發言中提到的那樣，今年這一數字已經恢復。我認為就長期成長軌跡而言，它實際上涉及新的地域，以及最終在血漿業務方面實現一些成長，而血漿業務一直落後於血小板的採用。因此我認為，我們對於我們在歐洲的地理機會非常有信心。話雖如此，但確實很難準確預測這些大帳戶何時會上線。所以我不知道這是否回答了你的問題，比爾？

Yes. No, absolutely. That's really helpful. And then just on CE Mark, is there anything more you can tell us there? I think you've said hopeful expected timing by the end of this year, but just what sort of has to happen between now and then? And any other color you can give us on timing would be great on red blood cell, obviously.

是的。不，絕對不是。這真的很有幫助。那麼關於 CE 標誌，您還有什麼可以告訴我們的嗎？我想您說過預計時間是在今年年底，但是從現在到那時到底會發生什麼事？顯然，您在時間上提供的任何其他顏色對於紅血球來說都是很好的。

Thanks a lot, Bill. So your question is specific to CE Mark timing under the MDR process. And unfortunately, Carol Moore is on the call with us. So I'll turn it over to Carol. She's our Senior Vice President of Regulatory and Quality.

非常感謝，比爾。所以您的問題是關於 MDR 流程下的 CE 標誌時間安排的。不幸的是，卡羅爾摩爾 (Carol Moore) 正在與我們通話。因此我將把它交給卡羅爾。她是我們監管和品質部門的高級副總裁。

Thank you. Thanks for the question. We are working closely with our competent authority, which is in the Netherlands to finish up any questions they might have on the responses we provided earlier this year. We have not heard back from them, but we did provide a complete response. And between receiving some feedback from our component authority, we still will go back and talk to our notified body, which is the TUV and determine what the next steps are towards completing the application. So we'll be in a better position once we hear back from our component authority about the responses that we provided earlier this year.

謝謝。謝謝你的提問。我們正在與荷蘭的主管部門密切合作，以解決他們對我們今年早些時候提供的答覆可能存在的任何疑問。我們尚未收到他們的回复，但我們確實提供了完整的答复。在收到零件主管機關的一些回饋後，我們仍會回去與我們的公告機構，即 TUV 進行溝通，以確定完成申請的下一步措施。因此，一旦我們從組成主管部門收到有關我們今年早些時候提供的答案的回饋，我們將處於更有利的位置。

Okay. And based on what you know thus far, though, I mean, any change to your thinking on timing?

好的。但是，根據您目前所知，您對時間安排的想法有任何改變嗎？

Well, I think we're just in an active review process. So at times, it's hard to predict what might come up next. But I think we're working hard to make sure that we fulfill any requests that we receive in the most timely way.

嗯，我認為我們正處於積極的審查過程中。因此有時很難預測接下來會發生什麼。但我認為我們正在努力確保以最及時的方式滿足我們收到的任何請求。

Okay. That's helpful. And then just one last question on cash flow and happy to hear your thoughts about potentially being operating cash flow for the year and obviously seeing it for Q1. Just anything particularly unusual. I think we had some unusual working capital moves in Q4, probably that hurt operating cash flow. Do we sort of see a reverse of that helping Q1? Or how do we sort of think about it in the future quarters?

好的。這很有幫助。然後最後一個問題是關於現金流的，很高興聽到您對今年潛在經營現金流的看法，並且顯然會看到第一季的經營現金流。只是任何特別不尋常的事情。我認為我們在第四季有一些不尋常的營運資本變動，這可能會損害營運現金流。我們是否看到了對第一季有幫助的逆轉？或者我們對未來幾季會如何考慮這個問題？

Yes, Bill, I'll take that one. So you're right. In Q4, actually 2023 at large, we saw kind of atypical working capital movements with increased inventory and rapidly declining payables. I think when we ended the year, we felt like we were in a position where we could reverse that. Q1 was really the first time. I think you see the inventories coming down. Obviously, our receivables have come down, for that matter, payables have come down. I think we're cautiously optimistic for the balance of the year. Obviously, there could be chop in any given quarter.

是的，比爾，我接受這個。所以你是對的。在第四季度，實際上是整個 2023 年，我們看到了一種非典型的營運資本變動，庫存增加，應付款項迅速下降。我想，當我們結束這一年的時候，我們感覺我們處於一個可以扭轉這一局面的位置。 Q1 確實是第一次。我認為你會看到庫存正在下降。顯然，我們的應收帳款下降了，應付帳款也下降了。我認為我們對今年的平衡持謹慎樂觀的態度。顯然，任何一個季度都可能出現裁員。

But if you think about our guidance in Q1 being kind of the low watermark for the year, I think we expect to see continued growth in the top line will continue to work down inventory levels. And then really, it comes down to managing the payables and the receivables at the current DSO and DPO levels, which we think is manageable. So I think there's a lot of fundamental reasons to be confident that we can generate operating cash flow, and we'll manage towards that.

但如果您認為我們第一季的預期是今年的低水位，那麼我們預計營收將繼續成長，庫存水準將繼續下降。然後實際上，它歸結為在當前 DSO 和 DPO 水平上管理應付款項和應收款項，我們認為這是可管理的。因此，我認為有很多根本原因讓我們有信心產生經營現金流，而且我們會努力實現這一目標。

Thank you. I would now like to turn the call back over to Obi Greenman for any closing remarks.

謝謝。現在我想將電話轉回給奧比·格林曼，請他做最後發言。

Well, thank you again for joining us today and for your interest in Cerus. We look forward to keeping you informed of our progress throughout the rest of 2024. Thank you.

好吧，再次感謝您今天加入我們並感謝您對 Cerus 的關注。我們期待在 2024 年剩餘時間內向您通報我們的進展。

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

謝謝。會議到此結束。感謝您的參與。您現在可以斷開連線。