Cerus Corp (CERS) 2025 Q2 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation second quarter 2025 earnings conference call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Tim Lee, Cerus' Head of Investor Relations. Tim, you may now begin.

女士們、先生們，大家好。感謝您的耐心等待，歡迎參加 Cerus 公司 2025 年第二季財報電話會議。請注意，今天的會議正在錄影。現在我將把會議交給Cerus投資者關係主管Tim Lee。提姆，你可以開始了。

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.cerus.com.

謝謝，下午好。感謝各位今天蒞臨現場。作為今天網路直播的一部分，我們將同時展示您可以跟隨觀看的幻燈片。您可以從投資者關係網站 ir.cerus.com 取得幻燈片。

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.

與我一同參加電話會議的有：Cerus 總裁兼執行長 Obi Greenman；Cerus 營運長 Vivek Jayaraman；Cerus 財務長 Kevin Green；以及 Cerus 資深副總裁 Carol Moore。

Cerus issued a press release today announcing our financial results for the second quarter ended June 30, 2025, and describing the company's recent business highlights. You can access a copy of this announcement on the company's website at www.cerus.com. I'd like to remind you that some of the statements we will make on this call relate to future events and performance rather than historical facts and are forward-looking statements.

Cerus今天發布新聞稿，公佈了截至2025年6月30日的第二季財務業績，並介紹了該公司近期的業務亮點。您可以在公司網站www.cerus.com上查閱此公告的副本。我想提醒各位，我們在本次電話會議上所作的一些陳述涉及未來事件和業績，而非歷史事實，因此屬於前瞻性陳述。

Examples of forward-looking statements include those related to our future financial and operating results, including our 2025 revenue guidance, our expectations for operating cash flow 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, product launches, product expansion prospects and other statements that are not historical facts. These forward-looking statements involve risks and uncertainties that could cause actual events, performance, and results to differ materially.

前瞻性陳述的例子包括與我們未來的財務和經營業績相關的陳述，包括我們的 2025 年收入預期、我們對經營現金流量和非 GAAP 調整 EBITDA 業績的預期、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安排、計劃的監管申報、產品發布、產品的監管申報、產品發布的前景。這些前瞻性陳述涉及風險和不確定性，可能導致實際事件、績效和結果與預期有重大差異。

They are identified and described in today's press release and our slide presentation and under Risk Factors in our Form 10-Q for the quarter ended June 30, 2025, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements.

這些風險因素已在今天的新聞稿和我們的幻燈片演示中進行了識別和描述，並在我們即將提交的截至 2025 年 6 月 30 日的季度 10-Q 表格的「風險因素」部分中進行了描述。我們不承擔更新前瞻性聲明的義務。

On today's call, we will also be describing 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.

在今天的電話會議上，我們也將介紹非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編製的指標的補充，而不是替代。

For a reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures to the extent reasonably available, please refer to today's press release and the slide presentation available on our website.

如需了解非公認會計準則財務指標與最可比較的公認會計準則財務指標的調節情況（在合理可行的範圍內），請參閱我們網站上發布的今日新聞稿和幻燈片簡報。

We'll begin today with opening remarks from Obi, followed by Vivek to discuss recent business highlights, and Kevin to review our financial results and expectations for the rest of 2025 and lastly, closing remarks from Obi. And now it's my pleasure to introduce Obi Greenman, Cerus' President and Chief Executive Officer.

今天我們將首先由 Obi 致開幕詞，然後由 Vivek 討論最近的業務亮點，Kevin 回顧我們的財務業績和對 2025 年剩餘時間的預期，最後由 Obi 致閉幕詞。現在，我很榮幸地向大家介紹 Cerus 的總裁兼執行長 Obi Greenman。

Thank you, Tim, and good afternoon, everyone. I would like to open the call with a review of the highlights from the second quarter as well as our outlook for the duration of the year. As we continue to grow our business and advance our complete INTERCEPT product portfolio, I'm very happy to report to you all today another quarter of both solid commercial and product development execution.

謝謝你，提姆，大家下午好。我想先回顧一下第二季的亮點以及我們對全年的展望。隨著我們業務的不斷發展和 INTERCEPT 全線產品組合的推進，我很高興地向大家報告，我們又一個季度在商業和產品開發方面都取得了穩健的進展。

Guided by our mission to fundamentally transform the safety and availability of transfused blood components, we are realizing a growing foundation of clinical evidence that is helping to establish the INTERCEPT Blood System as the standard of care in transfusion medicine in many countries around the world. The strong revenue growth we experienced during the first quarter continued through Q2, delivering record quarterly sales for the company and a near doubling of our IFC revenue quarter over quarter.

秉承著從根本上改變輸血成分的安全性和可及性的使命，我們正在積累越來越多的臨床證據，這有助於將 INTERCEPT 血液系統確立為世界許多國家輸血醫學的標準護理。我們在第一季經歷的強勁營收成長勢頭延續到了第二季度，為公司帶來了創紀錄的季度銷售額，並且我們的 IFC 營收環比增長了近一倍。

In fact, our IFC revenue for the first half of 2025 nearly surpassed the full year IFC revenue for 2024. As a result, we are increasingly confident in our ability to exceed our full year 2025 product revenue guidance that we outlined in January. Accordingly, we are raising our full year 2025 product revenue guidance to a range of $200 million to $203 million from our previous range of $194 million to $200 million.

事實上，我們 2025 年上半年的 IFC 收入幾乎超過了 2024 年全年的 IFC 收入。因此，我們越來越有信心能夠超越我們在 1 月提出的 2025 年全年產品收入預期。因此，我們將 2025 年全年產品收入預期從先前的 1.94 億美元至 2 億美元上調至 2 億美元至 2.03 億美元。

While we are seeing growth across our entire INTERCEPT product offering and in each region, the increase in our full year revenue guidance range is largely driven by increasing customer demand for IFC. Its ready availability and positive impact on the complex hospital operations required to manage critically bleeding patients are being acknowledged across the US broadly.

雖然我們看到 INTERCEPT 的整個產品系列以及每個地區都在成長，但我們全年收入預期範圍的增加主要是由客戶對 IFC 的需求不斷增長所驅動的。它的便利性和對管理危重出血患者所需的複雜醫院運作的積極影響正在全美範圍內得到廣泛認可。

Vivek will provide additional color on the exciting growth in our US IFC business in his prepared remarks. Our core platelet franchise continues to be a key driver for revenue growth as well, both in the US and abroad.

Vivek 將在事先準備好的演講稿中，進一步闡述我們在美國 IFC 業務的令人振奮的成長情況。我們的核心血小板業務仍然是美國和海外收入成長的關鍵驅動力。

In the US, we are expecting increasing adoption of pathogen-reduced platelets as hospital demand for 100% pathogen inactivated platelet inventory increases because of the benefits associated with managing the logistics and inventories for platelet transfusion. In international markets, we continue to have a dialogue with many regulators, national blood services and large blood centers about global platelet safety standards and the important technological role that INTERCEPT can play.

在美國，由於血小板輸注的物流和庫存管理的優勢，醫院對 100% 病原體滅活血小板的需求增加，我們預期病原體滅活血小板的使用率將會提高。在國際市場上，我們繼續與許多監管機構、國家血液服務機構和大型血液中心就全球血小板安全標準以及 INTERCEPT 可以發揮的重要技術作用進行對話。

Our portfolio of products, including our next-generation illuminators, the INT200, were recently showcased at the International Society of Blood Transfusion Congress in Milan. Having received CE Mark at the end of the first quarter, this Congress served as a great forum to launch the product and to introduce it to our customers as well as our global distribution partners. Feedback on the INT200 continues to be very positive.

我們包括新一代照明器 INT200 在內的產品組合最近在米蘭舉行的國際輸血協會大會上進行了展示。在第一季末獲得 CE 標誌後，本次大會為產品發布、向我們的客戶以及全球分銷合作夥伴介紹產品提供了一個絕佳的平台。用戶對 INT200 的回饋一直非常積極。

We have begun deploying the first of these devices in the field and expect that the device will be a foundational component of blood center operations. We are now approved for commercial sale in approximately 40 countries, and the launch allows for new opportunities to engage with blood center customers and reinforces Cerus' innovation in the field of transfusion medicine. Switching to our red blood cell program. In Europe, as we announced last month, the regulatory review is advancing ahead of plan.

我們已開始在現場部署首批此類設備，並期望該設備將成為血液中心運作的基礎組成部分。目前，我們的產品已獲准在約 40 個國家/地區進行商業銷售，此次上市為我們與血液中心客戶互動提供了新的機會，並鞏固了 Cerus 在輸血醫學領域的創新地位。轉而使用我們的紅血球輸注方案。正如我們上個月宣布的那樣，歐洲的監管審查進展比計劃更快。

TÜV-SÜD, our notified body, has completed their review of several modules of the submission, including the clinical module and transferred the dossier to the State Institute for Drug Control, SÚKL, in the Czech Republic for consultation.

我們的認證機構 TøV-SøD 已完成對提交資料的幾個模組的審查，包括臨床模組，並將檔案移交給捷克共和國國家藥品控制研究所 (SøKL) 進行諮詢。

SÚKL, our competent authority, has started the review of the active pharmaceutical ingredient or API. The clinical module included the positive results from the Phase 3 ReCePI clinical trial, thereby expanding our CE Mark submission to cover all patient indications for red cell transfusion.

我們的主管機構 SÃKL 已開始對活性藥物成分 (API) 進行審查。臨床模組包含了 ReCePI 3 期臨床試驗的積極結果，從而擴大了我們的 CE 標誌申請範圍，涵蓋了所有紅血球輸注的患者適應症。

The previous submission focused only on the chronic transfusion indication. We are looking forward to working collaboratively with both TÜV-SÜD and SÚKL to facilitate the completion of the review process and expect a CE Mark approval decision in the second half of 2026. We also recently just announced a significant award of $7.2 million from the US Defense Department for the funding of a four-center study called CRYO-FIRST that will evaluate the utility of early IFC in the treatment of major bleeding events in trauma patients.

先前的提交只關注了慢性輸血適應症。我們期待與 Tøv-Sød 和 SøkL 合作，以促進審查過程的完成，並預計在 2026 年下半年獲得 CE 標誌批准決定。我們最近還宣布，美國國防部撥款 720 萬美元，用於資助一項名為 CRYO-FIRST 的四中心研究，該研究將評估早期 IFC 在治療創傷患者大出血事件中的作用。

This study is meant to be a pilot clinical study for the future clinical development of a lyophilized version of IFC for potential use in austere environments and in pre-hospital and regional hospital trauma care.

本研究旨在作為一項試點臨床研究，為未來開發凍乾版 IFC 以用於條件艱苦的環境以及院前和區域醫院創傷護理的潛在用途做準備。

We believe that the data from CRYO-FIRST will have potential future utility in defining the clinical benefits associated with early access to fibrinogen. Last but not least, switching to our financials, we continue to execute against our stated goals and remain steadfast in our goal to once again achieve positive non-GAAP adjusted EBITDA. Kevin will provide additional details on this and our full financial results in his prepared remarks.

我們相信，CRYO-FIRST 的數據在未來可能有助於確定早期獲得纖維蛋白原所帶來的臨床益處。最後，談到我們的財務狀況，我們繼續朝著既定目標努力，並堅定不移地朝著再次實現正的非GAAP調整EBITDA的目標邁進。凱文將在事先準備好的發言稿中提供更多細節以及我們的完整財務表現。

With that, I would now like to turn the call over to Vivek to discuss our second quarter commercial results, along with color on our outlook for 2025.

接下來，我想把電話交給 Vivek，讓他來討論我們第二季的商業業績，並展望一下我們對 2025 年的前景。

Thank you, Obi, and good afternoon, everyone. As Obi mentioned, we delivered another strong quarter of commercial execution in Q2. Our record product revenue underscores the progress we are making across multiple geographies and throughout our INTERCEPT product portfolio.

謝謝你，奧比，大家下午好。正如奧比所說，我們在第二季又取得了強勁的商業執行表現。我們創紀錄的產品收入凸顯了我們在多個地區和整個 INTERCEPT 產品組合中取得的進展。

Product revenue growth of 16% for the second quarter was driven primarily by increasing customer demand for INTERCEPT's fibrinogen complex as well as continued platelet sales growth in both the US and EMEA region.

第二季產品營收成長 16%，主要得益於客戶對 INTERCEPT 纖維蛋白原複合物的需求不斷增長，以及美國和 EMEA 地區血小板銷售的持續成長。

ISV demand continues to increase, reinforcing the growing adoption of this novel product as hospitals and clinicians gain confidence in its clinical and operational benefits. Regionally, we saw solid momentum across EMEA, where deeper platelet penetration, incremental plasma contribution and the launch of the INT200 Illuminator all contributed meaningfully to solid first half results.

ISV 需求持續成長，醫院和臨床醫生對其臨床和營運優勢的信心不斷增強，進一步鞏固了這種新型產品的普及應用。從區域來看，我們在歐洲、中東和非洲地區看到了強勁的發展勢頭，其中血小板滲透率的提高、血漿貢獻的增加以及INT200 Illuminator的推出都對上半年的良好業績做出了重要貢獻。

Canadian Blood Services has now fully transitioned to 100% routine use of INTERCEPT platelets, and we continue to expand our footprint in the Middle East with Saudi Arabia, Kuwait and the UAE leading platelet growth so far this year.

加拿大血液服務中心現已全面過渡到 100% 常規使用 INTERCEPT 血小板，並且我們繼續擴大在中東的業務，今年迄今為止，沙烏地阿拉伯、科威特和阿聯酋的血小板成長領先。

On the plasma side, Red Cross Flanders and Madrid selected INTERCEPT to replace a competing pathogen reduction technology, further validating the strength of our franchise. The INT200 Illuminator continues to resonate with customers and regulators alike. In addition to its CE Mark approval, the device is now approved in France by the ANSM and in Switzerland by Swissmedic.

在血漿方面，紅十字會弗蘭德斯和馬德里選擇 INTERCEPT 來取代競爭性的病原體減少技術，進一步驗證了我們產品的強度。INT200 照明器持續受到客戶和監管機構的關注。除了獲得 CE 標誌認證外，該設備現在還獲得了法國 ANSM 和瑞士 Swissmedic 的批准。

We successfully launched INT200 during the quarter and have been receiving highly encouraging feedback from customers to evaluate operational efficiency and user-friendly design. In Germany, the Paul-Ehrlich-Institut, the National Agency regulating blood components, is considering new requirements to further minimize the risk of transfusion-transmitted bacterial infections.

本季度我們成功推出了 INT200，並收到了客戶的高度鼓勵回饋，以評估其營運效率和用戶友好性設計。在德國，負責監管血液成分的國家機構保羅·埃爾利希研究所正在考慮新的要求，以進一步降低輸血傳播細菌感染的風險。

These measures may include mandatory implementation of either pathogen reduction and/or bacterial testing for all platelet units similar to the FDA's bacterial safety standards in the US. While this process is still ongoing, we believe that such a regulatory shift could create a positive environment for broader INTERCEPT platelet adoption in Germany over time.

這些措施可能包括強制實施病原體減少和/或細菌檢測，以符合美國FDA的細菌安全標準，對所有血小板單位進行檢測。雖然這個過程仍在進行中，但我們相信，隨著時間的推移，這種監管轉變可能會為德國更廣泛地採用 INTERCEPT 血小板創造一個積極的環境。

In China, the NMPA requested additional pathogen inactivation and in vitro platelet quality data tailored to local processing requirements for our submission. We believe that providing this China-specific data will strengthen our submission and better support market adoption at launch. As a result, the decision was made to withdraw the current submission temporarily in order to generate and include this new data set.

在中國，國家藥品監督管理局要求我們提供根據當地加工要求量身定制的額外病原體滅活和體外血小板品質數據。我們相信，提供這些針對中國的具體數據將增強我們的申報資料，並更好地支持產品上市後的市場推廣。因此，決定暫時撤回目前的提交內容，以便產生並納入這個新的資料集。

China remains a very compelling market opportunity for INTERCEPT and there's a high degree of clinical interest in this product. Turning to the US, in the second quarter, we continued to build strong clinical advocacy for INTERCEPT fibrinogen complex with leading physicians from the University of Virginia and Vanderbilt University presenting their early adopter experience at major US medical conferences.

中國仍然是 INTERCEPT 極具吸引力的市場機遇，並且該產品在臨床上引起了高度關注。轉戰美國市場，在第二季度，我們繼續加強對 INTERCEPT 纖維蛋白原複合物的臨床宣傳，弗吉尼亞大學和范德比爾特大學的頂尖醫生在美國主要醫學會議上介紹了他們的早期採用經驗。

At the Society of Cardiovascular anesthesiologist, Dr. John McNeil highlighted how IFC is being rapidly integrated into cardiac surgery workflows, enabling platelet and IFC delivery within minutes across both pediatric and adult populations.

在心血管麻醉醫師協會上，約翰·麥克尼爾博士重點介紹了 IFC 如何迅速融入心臟外科手術工作流程，從而能夠在幾分鐘內為兒童和成人患者提供血小板和 IFC。

At the Society for Obstetric Anesthesia and Perinatology, Vanderbilt physicians shared compelling interim data showing IFC's role in avoiding unnecessary massive transfusion protocol activation in postpartum hemorrhage, reducing blood component utilization and eliminating wastage.

在婦產科麻醉和圍產醫學會上，范德比爾特大學的醫生分享了令人信服的中期數據，表明 IFC 在避免產後出血中不必要的大量輸血方案啟動、減少血液成分使用和消除浪費方面發揮了作用。

These real-world insights are accelerating awareness and confidence among key clinical specialties, reinforcing IFC's potential to redefine transfusion support in critical care settings. For those of you interested in learning more about these presentations, a recording of Dr. McNeil's presentation is available under the Resources section of the website at www.inercept-usa.com.

這些來自現實世界的見解正在加速關鍵臨床專科的認識和信心，從而增強了 IFC 在重症監護環境中重新定義輸血支持的潛力。如果您有興趣了解更多關於這些演講的信息，可以在網站 www.inercept-usa.com 的「資源」部分找到 McNeil 博士的演講錄音。

Beyond the US, we maintained a strong international presence, engaging transfusion leaders at national seminars in Switzerland, Austria, Canada, and Spain and also at the ISBT Regional Congress in Milan. As Obi previously mentioned, at the ISBT Congress, we had an opportunity to introduce the market to our new INT200 Illuminator and showcased extensive scientific data on INTERCEPT platelets, ISC and red cell programs, underscoring our commitment to advancing blood safety and operational efficiency.

除了美國以外，我們也保持著強大的國際影響力，在瑞士、奧地利、加拿大和西班牙舉辦的全國研討會上與輸血領域的領導者進行交流，並在米蘭舉行的國際輸血協會區域大會上與輸血領域的領導者互動。正如 Obi 之前提到的，在 ISBT 大會上，我們有機會向市場推出我們新的 INT200 照明器，並展示了有關 INTERCEPT 血小板、ISC 和紅血球項目的廣泛科學數據，強調了我們致力於提高血液安全性和運營效率的承諾。

These targeted educational initiatives are designed to strengthen our brand, expand our reach within transfusion medicine communities and support growing demand for INTERCEPT-treated blood components.

這些有針對性的教育措施旨在加強我們的品牌，擴大我們在輸血醫學界的影響力，並支持對 INTERCEPT 處理的血液成分日益增長的需求。

Looking ahead to our future growth prospects, we believe IFC will remain a key driver for Cerus for years to come. We also believe our platelet franchise has significant runway with continued adoption in the US, deeper penetration in existing international markets and opportunities to open up new international geographies.

展望未來的成長前景，我們相信IFC將在未來幾年繼續成為Cerus的關鍵驅動力。我們也相信，隨著血小板產品在美國的持續普及、在現有國際市場的更深入滲透以及開拓新的國際市場的機會，我們的血小板產品線還有很大的發展空間。

Taken together, this quarter's results and the operational milestones we've achieved give us confidence that the growth trajectory we are on is sustainable. While we remain mindful of macroeconomic and geopolitical factors, the durability of our value proposition and the breadth of our pipeline position us well to continue delivering meaningful innovation and expanding access to safer blood products worldwide. With that, I'll now turn it over to Kevin to walk through our financial results and outlook in more detail.

綜合來看，本季的業績和我們所取得的營運里程碑讓我們有信心，我們目前的發展軌跡是可持續的。儘管我們始終關注宏觀經濟和地緣政治因素，但我們價值主張的持久性和產品線的廣泛性使我們能夠繼續提供有意義的創新，並擴大全球範圍內更安全血液製品的獲取途徑。接下來，我將把發言權交給凱文，讓他更詳細地介紹我們的財務表現和展望。

Thanks, Vivek. Hello, everyone. Thank you all for joining us. On today's call, I'll be discussing our financial results for the second quarter of 2025, our increased full year product revenue guidance, and providing some thoughts on our key metrics as we close out the first half and move into the back half of the year. With the exception of revenue, I'll be limiting my commentary on historical results to Q2 rather than year-to-date results.

謝謝你，維韋克。大家好。感謝各位的參與。在今天的電話會議上，我將討論我們 2025 年第二季度的財務業績、我們提高的全年產品收入預期，並就我們即將結束上半年並進入下半年的關鍵指標提出一些看法。除了營收之外，我對歷史業績的評論將僅限於第二季度，而不是年初至今的業績。

So I'll start off with product revenue. For the second quarter of 2025, we reported product revenue of $52.4 million, translating to a 16% year-over-year increase. For the full first half, product revenue increased 15% to $95.7 million compared to the first half of 2024. IFC sales in the US as well as global platelet sales were the principal drivers of product revenue growth this quarter.

那麼，我就先從產品收入說起。2025 年第二季度，我們的產品營收為 5,240 萬美元，年增 16%。與 2024 年上半年相比，今年上半年產品營收成長 15%，達到 9,570 萬美元。本季度，IFC 在美國的銷售額以及全球血小板銷售額是產品收入成長的主要驅動力。

Breaking down product revenues by geography, we see that second quarter North American product revenues increased 17% compared to the same period from the prior year. Second quarter EMEA product revenues increased 21% compared to the same period last year due in part to the strength in Middle Eastern platelet sales and expansion of our plasma business from historical platelet accounts.

以地理劃分產品收入，我們發現第二季北美產品收入比去年同期成長了 17%。與去年同期相比，第二季 EMEA 產品收入成長了 21%，部分原因是中東血小板銷售強勁，以及我們血漿業務從歷史血小板客戶中擴張。

On a non-GAAP basis, excluding the impact of foreign currency exchange rates, EMEA product revenue increased 15%. As we look ahead, we expect that the launch of our LED illuminator in Europe, which kicked off at the end of the first quarter will add to EMEA's growth. IFC product revenue for the second quarter was $5.6 million compared to $2 million during the prior year period.

不計外匯匯率的影響，以非GAAP準則計算，EMEA產品收入成長了15%。展望未來，我們預計第一季末在歐洲推出的 LED 照明器將促進 EMEA 地區的成長。IFC產品第二季營收為560萬美元，而上年同期為200萬美元。

We did recognize approximately $800,000 of previously deferred IFC revenue during Q2. Our IFC product revenue is strengthening from increasing customer demand and product availability. With the production capacity currently available, we expect we will be able to supply the anticipated growth in demand for the back half of the year.

我們在第二季確認了約 80 萬美元之前遞延的 IFC 收入。由於客戶需求和產品供應量不斷增長，我們的IFC產品收入正在穩步提升。以目前的生產能力，我們預計能夠滿足下半年預期成長的需求。

Based on our strong year-to-date commercial execution and increasing conviction in our growth projections, we are raising our full year 2025 product revenue guidance range to $200 million to $203 million compared to our previous guidance range of $194 million to $200 million. Included in that, we now expect full year 2025 IFC sales to be in a range of $16 million to $18 million compared to our previous guidance range of $12 million to $15 million.

基於我們今年迄今強勁的商業執行力以及對成長預測日益增長的信心，我們將 2025 年全年產品收入預期範圍從之前的 1.94 億美元至 2 億美元上調至 2 億美元至 2.03 億美元。其中包括，我們現在預計 2025 年全年 IFC 銷售額將在 1,600 萬美元至 1,800 萬美元之間，而我們先前預期的範圍為 1,200 萬美元至 1,500 萬美元。

In the near term, we continue to expect increasing IFC revenue to be a key contributor to our overall growth. Beyond product revenue and not included in our guidance, government contract revenue for the second quarter of 2025 was $7.7 million compared to $5.4 million for the prior year period.

短期內，我們仍然預期 IFC 收入的成長將成為我們整體成長的關鍵貢獻因素。除了產品收入之外，且未包含在我們的預期中，2025 年第二季的政府合約收入為 770 萬美元，而去年同期為 540 萬美元。

Enrollment in our RedeS trial as well as the commencement of new activities covered under our BARDA contracts drove the increase in government contract revenue. While we continue to be actively engaged with our government sponsors, we are seeing some impact from the ongoing changes in Washington, including back-office administrative delays and the timing of award modifications. Turning now to our product gross profit and gross margins.

參與 RedeS 試驗以及開展 BARDA 合約涵蓋的新活動推動了政府合約收入的成長。儘管我們仍在積極與政府贊助商保持溝通，但華盛頓的持續變化確實對我們產生了一些影響，包括後台行政延誤和撥款修改的時間表。現在來看看我們的產品毛利和毛利率。

Our second quarter product gross profit was $29 million compared to $24.7 million during the prior year period, an increase of 17% year over year. Product gross margins for the second quarter were 55.2%, comparable to the 54.7% realized during the second quarter of the prior year. A number of offsetting factors drove the relatively stable margins.

我們第二季的產品毛利為 2,900 萬美元，而去年同期為 2,470 萬美元，較去年同期成長 17%。第二季產品毛利率為 55.2%，與去年同期的 54.7% 基本持平。多種相互抵銷的因素促成了相對穩定的利潤率。

Economies of scale with increased volumes, FX rates, and higher ASPs provided a tailwind, while inflation and product mix tempered those factors. As we look ahead to the balance of the year, we expect product gross margins will generally remain in the mid-50s, but face some potential modest headwinds such as foreign exchange rates.

規模經濟（銷售增加）、匯率波動和平均售價上漲帶來了利好，而通貨膨脹和產品組合則抑制了這些因素。展望今年剩餘時間，我們預計產品毛利率將整體維持在 50% 左右，但可能會面臨一些輕微的不利因素，例如匯率波動。

Other factors that could drive quarterly variability include, but are not limited to, product mix, production costs of IFC to meet increasing demand, economies of scale and production volumes, and the timing of COGS reduction initiatives coming online. Moving down the income statement. Operating expenses for the second quarter totaled $40.1 million compared to $33.9 million for Q2 2024.

其他可能導致季度波動的因素包括但不限於產品組合、為滿足不斷增長的需求而增加的 IFC 生產成本、規模經濟和產量，以及降低銷售成本計劃上線的時間。從損益表向下看。第二季營運費用總計 4,010 萬美元，而 2024 年第二季為 3,390 萬美元。

Of the total operating expenses reported for the second quarter, R&D expenses totaled $18.9 million compared to $15 million during the prior year. The year-over-year increase in R&D expenses was primarily related to higher development costs of the INT200, higher government contract costs, which in turn drove the increased government contract revenue and higher employee compensation costs driven by the cost of living adjustments, which became effective earlier in the year.

在第二季報告的總營運支出中，研發支出總計 1,890 萬美元，而去年同期為 1,500 萬美元。研發費用較去年增加主要與 INT200 的開發成本較高、政府合約成本較高有關，而政府合約成本較高又導致政府合約收入增加，以及由於生活成本調整（該調整於今年稍早生效）而導致員工薪酬成本增加。

SG&A expenses for the first quarter were $21.2 million compared to $19 million in Q2 of 2024. The year-over-year increase in SG&A expenses reflect the cost of living adjustments for our employees as anticipated and noted during our Q1 call.

第一季銷售、一般及行政費用為 2,120 萬美元，而 2024 年第二季為 1,900 萬美元。銷售、一般及行政費用較去年同期增加，反映了我們員工生活成本的調整，正如我們在第一季電話會議上所預期和指出的那樣。

As with the past several years, we are driving the business forward with increasing levels of leverage from our SG&A investments. We expect that the second half of the year will see more of this dynamic, which is central to our strategic business model.

與過去幾年一樣，我們正利用銷售、一般及行政費用投資不斷提高槓桿作用，推動業務向前發展。我們預期下半年這種動態將更加明顯，而這正是我們策略商業模式的核心。

Shifting our focus to the bottom line and non-GAAP adjusted EBITDA results. On the bottom line, for Q2 2025, net loss attributable to Cerus was $5.7 million or $0.03 per share and essentially flat compared to the second quarter of 2024.

我們將重點轉向最終收益和非GAAP調整後的EBITDA績效。最終，2025 年第二季歸屬於 Cerus 的淨虧損為 570 萬美元，即每股虧損 0.03 美元，與 2024 年第二季基本持平。

On a non-GAAP adjusted EBITDA basis, we are pleased to report our fifth consecutive quarter of positive non-GAAP adjusted EBITDA totaling $935,000 for the second quarter compared to $779,000 for the prior year period.

以非GAAP調整後的EBITDA計算，我們很高興地宣布，我們連續第五個季度實現了正的非GAAP調整後EBITDA，第二季度總計935,000美元，而上年同期為779,000美元。

We remain steadfast in our goal of achieving full year positive adjusted EBITDA and expect expansion of gross profit, stability of OpEx and importantly, expanding leverage from our SG&A investments will all contribute to achieving this objective.

我們仍堅定不移地朝著全年調整後 EBITDA 為正的目標邁進，並期望毛利的成長、營運支出的穩定以及至關重要的銷售、一般及行政費用投資槓桿的擴大，都將有助於實現這一目標。

Turning to the balance sheet and associated cash flows. We ended the second quarter with $78 million of cash, cash equivalents, and short-term investments on hand compared to $80.5 million at the end of 2024. As you can see, we've continued to manage the growth in our business with a stable cash balance supported by our growing operations. Cash used from operations increased slightly on a sequential basis at $2.4 million.

接下來來看資產負債表和相關的現金流量表。第二季末，我們手頭現金、現金等價物和短期投資為 7,800 萬美元，而 2024 年底則為 8,050 萬美元。如您所見，我們透過不斷成長的業務，保持了穩定的現金餘額，從而持續管理業務成長。經營活動所用現金較上月略有增加，為 240 萬美元。

This was anticipated and was driven by investments in working capital, namely inventory to support expected growth and an increase in our accounts receivable due to administrative delays and timing of payments from the US government for our development contracts.

這是預料之中的，主要原因是營運資金投資，即為支持預期增長而進行的庫存投資，以及由於美國政府對我們開發合約的行政延誤和付款時間安排而導致的應收賬款增加。

Despite the modest net use of operating cash and working capital investments, we believe we are still in a position to deliver annual positive operating cash flow to fuel our growth going forward. Furthermore, we expect to have increasing access to our revolving line of credit, should we choose to further use that facility and offset receivable or inventory-related working capital investments. With that, let me turn it back over to Obi for some closing remarks.

儘管經營現金和營運資本投資的淨使用量不大，但我們相信我們仍然能夠實現年度正經營現金流，從而推動我們未來的成長。此外，如果我們選擇進一步使用該信貸額度來抵銷應收帳款或庫存相關的營運資金投資，我們預計我們將能夠越來越多地使用該信貸額度。那麼，現在讓我把麥克風交還給奧比，讓他做些總結發言。

Thank you, Kevin. The strong commercial results and progress in product development that we announced today has allowed us to deliver one of the strongest quarters in the company's history. We delivered $52 million in quarterly product revenue, led by robust IFC sales.

謝謝你，凱文。今天我們宣布的強勁商業業績和產品開發進展，使我們得以實現公司歷史上最強勁的季度業績之一。本季產品營收達 5,200 萬美元，其中 IFC 銷售強勁成長。

We raised our full year 2025 product revenue guidance due to expected continued revenue growth, and we realized our fifth consecutive quarter of positive non-GAAP adjusted EBITDA. I'd like to express my deep gratitude to the Cerus team and our blood center partners around the globe for their steadfast commitment to improving blood safety and availability for patients and enabling the INTERCEPT Blood System to become the standard of care in many countries.

由於預期收入將持續成長，我們提高了 2025 年全年產品收入預期，並且我們實現了連續第五個季度非 GAAP 調整後 EBITDA 為正值。我謹向 Cerus 團隊和我們在全球各地的血液中心合作夥伴表達我深深的謝意，感謝他們堅定不移地致力於提高患者的血液安全性和可及性，並使 INTERCEPT 血液系統成為許多國家的標準護理。

With more than 20 million INTERCEPT-treated components transfused into patients now, the scale of our Impact daily on the field of transfusion medicine is really remarkable and expected to increase meaningfully by the end of the decade.

目前已有超過 2,000 萬份經 INTERCEPT 處理的血液成分輸注給患者，我們每天對輸血醫學領域的影響規模確實非常顯著，預計到本世紀末將顯著增加。

The recent launch of our INT200 LED Illuminator facilitating an unconstrained platform placement, the continued progress of our IFC business, and the anticipated regulatory approval of our INTERCEPT red blood cell program in Europe, are expected to deepen our relationships with our existing and future customers. With that, let me turn it over to the operator for questions.

最近推出的 INT200 LED 照明器實現了不受限制的平台放置，IFC 業務的持續發展，以及 INTERCEPT 紅血球項目在歐洲的預期監管批准，預計將加深我們與現有和未來客戶的關係。那麼，接下來我將把發言權交給接線員，回答大家的問題。

(Operator Instructions)

（操作說明）

Josh Jennings, TD Cowen.

喬什·詹寧斯，TD Cowen。

This is Eric on for Josh. Maybe to start on revenue guidance for the year. That was a great update with the raise. I was just wondering if you could touch on the expected cadence of revenue through the remainder of the year. Maybe should we perhaps look at 2024 as a precedent? Just curious there.

這是埃里克替喬許發言。或許可以先發布今年的營收預期。這次加薪真是個好消息。我想問一下，您能否談談今年剩餘時間的預期收入水準？或許我們應該把2024年當作先例？只是好奇而已。

Yeah. Thanks a lot, Eric. Kevin, do you want to handle that?

是的。非常感謝，埃里克。凱文，你想處理這件事嗎？

Sure. We expect, obviously, as implied by our revenue guidance, continued growth in the back half of the year relative to the first half. What we've seen historically in EMEA, and I think that will play out again is somewhat of a flattening from Q2 to Q3, just given the summer holiday season.

當然。正如我們的營收預期所暗示的那樣，我們顯然預計下半年營收將比上半年繼續成長。我們從歐洲、中東和非洲地區的歷史數據來看，我認為這種情況還會再次出現，那就是從第二季到第三季會出現一定程度的趨於平緩，這主要是因為夏季假期的影響。

And then as we pointed out in the prepared remarks, we did have some deferred revenue that was recognized in Q2 that obviously won't be recognized in the back half of the year. So we expect that, again, we'll see growth, but it will be somewhat tempered in Q3. And then historically, we've seen a pretty robust jump in Q4.

正如我們在準備好的演講稿中指出的那樣，我們在第二季度確認了一些遞延收入，這些收入顯然不會在今年下半年確認。因此我們預計，第三季仍將保持成長，但成長速度會有所放緩。從歷史數據來看，第四季通常會出現相當強勁的成長。

Okay. That's helpful. And then maybe looking at the EU red blood cell opportunity, with the expanded CE Mark submission that you have now to cover all patient indications for red blood cell transfusion, is there a way to possibly quantify how that changes the way you're viewing the TAM that you could be addressing relative to that initial submission for chronic transfusion patients?

好的。那很有幫助。然後，或許可以看看歐盟紅血球市場的機會，您現在已經提交了擴大的 CE 標誌申請，涵蓋所有紅血球輸注的患者適應症，有沒有辦法量化這會如何改變您對潛在市場規模 (TAM) 的看法，以及您相對於最初針對慢性輸血患者的申請而言，這會如何改變您的看法？

Yeah. Thanks a lot, Eric. I'll take that. And I think basically, what we saw when we were going through the initial indication for just chronic transfusion recipients was that there would be a period of time in which we have sort of a mandatory HP requirement. In discussions right now with TÜV, still TBD, but it looks like that is no longer a requirement, and we'd be able to access all patient populations receiving red cell transfusion.

是的。非常感謝，埃里克。我接受。我認為，基本上，我們在最初針對慢性輸血接受者進行評估時發現，會有一段時間，我們需要強制執行HP要求。目前正在與 TøV 進行討論，結果尚未確定，但看起來這不再是要求了，我們將能夠接觸到所有接受紅血球輸注的患者群體。

So as we sort of think about the initial years post CE Mark approval, it just opens up all the opportunity to us and has fewer restrictions on the blood centers from how they choose to operate. So I think that's still TBD as far as how we'll roll the product out and then evolve the product offering post approval. But it is a welcomed reprieve, if you will, on sort of what the initial limitations would be on the launch.

因此，當我們思考獲得 CE 標誌批准後的最初幾年時，它為我們打開了所有的機會，並且對血液中心如何運作的限制也更少。所以，我認為產品將如何推出，以及在獲得批准後如何改進產品，目前仍待定。但從某種意義上說，這算是對發布初期可能的限制的一種緩解。

Ross Osborn, Cantor Fitzgerald.

羅斯·奧斯本，坎托·菲茨杰拉德。

This is Matt Park on for Ross today. I guess starting with the IFC guide, given the strong ramp in the first half and the increased guidance, can you walk us through the key drivers in hitting the revised guide? If I'm not mistaken, the updated range implies a slight deceleration half-over-half at the midpoint. Just trying to better understand the puts and takes as we think about quarterly cadence.

今天我是馬特·帕克，替羅斯為您報道。我想先從IFC的業績指引來看，鑑於上半年強勁的成長動能和不斷提高的業績指引，您能否為我們介紹一下實現修訂後業績指引的關鍵驅動因素？如果我沒理解錯的話，更新後的續航里程意味著在中點處略有減速。我們只是想更能理解季度節奏的買賣操作。

Thanks for the question, Matt. Vivek, do you want to handle this?

謝謝你的提問，馬特。維韋克，你想處理這件事嗎？

Sure, I'd be happy to. As Kevin indicated earlier on the call, we had some catch-up in the first half of the year associated with burning through some of the backlog and back orders we had that really started in the end of 2024. We're fully through that backlog at this point. And then we also had some Q1 revenue that from an accounting standpoint was recognized in the second quarter.

當然，我很樂意。正如凱文在電話會議上早些時候所指出的那樣，今年上半年我們有一些工作需要趕上進度，以消化一些積壓訂單和延期訂單，這些訂單和延期訂單實際上是從 2024 年底開始的。目前我們已經徹底處理完了積壓的工作。此外，我們還有一些第一季的收入，從會計角度來看，這些收入在第二季確認了。

That being said, the underlying growth we saw in Q2 and the increase in both supply of product and demand, both with existing hospitals want to increase their penetration of IFC as well as new hospitals onboarding, it's quite a strong pipeline.

也就是說，我們在第二季度看到的潛在成長，以及產品供應和需求的增加，無論是現有醫院希望提高對 IFC 的滲透率，還是新醫院的加入，都表明這是一個相當強勁的市場前景。

And so that's what led us to raising the guidance for the full year and our belief and confidence that we'll continue to see both an inflow of new hospital customers in Q3 and Q4 as well as increasing depth with existing customers. Probably the biggest driver of that being now that we have a much more comfortable supply position entering the back half of the year.

因此，正是基於這些原因，我們提高了全年的業績預期，我們相信並有信心在第三季和第四季繼續看到新醫院客戶的湧入，以及與現有客戶的合作深度加深。造成這種情況的最大原因可能是，進入下半年後，我們的供應狀況更加穩定。

Got it. Super helpful. And then I guess one more for me on OpEx. I guess, can you kind of parse out how much of the step-up reflects variable investment in growth versus, I guess, any onetime related spend? And I guess, how we should be thinking about expense cadence in the back half of the year?

知道了。非常有用。然後，我想我還需要一個關於營運支出的問題。我想，您能否大致分析一下，這種成長有多少反映了對成長的可變投資，又有多少反映了一次性相關支出？那麼，我們該如何考慮下半年的支出節奏呢？

Yeah, Matt, not so much onetime related spend. I think we are seeing an increase in government contract activity underwritten by BARDA, FDA, and DoD, and you'll see that corresponding increase in government contract revenue.

是的，馬特，不太是指一次性相關支出。我認為我們正在看到由生物醫學高級研究與發展局 (BARDA)、食品藥品監督管理局 (FDA) 和國防部 (DoD) 擔保的政府合約活動增加，你會看到政府合約收入相應增加。

So certainly, that's a component of the increase in R&D expense. And then as mentioned on the prepared remarks, we did see cost of living adjustments for our employees consistent with what you see with other companies, just given the inflationary environment that we've had to operate in the last few years.

所以，這無疑是研發支出增加的一個組成部分。正如我們在準備好的演講稿中所提到的，鑑於過去幾年我們不得不面對的通貨膨脹環境，我們確實對員工的生活成本進行了調整，這與其他公司的做法一致。

This concludes the question-and-answer session. I would now like to turn it back over to Mr. Greenman for closing remarks.

問答環節到此結束。現在我謹將發言權交還給格林曼先生，請他作總結發言。

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 2025 through quarterly calls and investor conferences. Thanks again.

再次感謝您今天蒞臨本站，也感謝您對 Cerus 的關注。我們期待在 2025 年剩餘的時間裡，透過季度電話會議和投資者會議，讓您隨時了解我們的進度。再次感謝。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。節目到此結束。您現在可以斷開連線了。