Cerus Corp (CERS) 2024 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 2024 earnings conference call.

美好的一天，女士們先生們。感謝您的耐心等待，歡迎參加 Cerus Corporation 2024 年第二季財報電話會議。

(Operator Instructions) Please be advised that today's conference is being recorded.

（操作員指示）請注意，今天的會議正在錄製中。

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

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

Thank you, and good afternoon. I'd like to thank everyone for joining us today.

謝謝你，下午好。我要感謝大家今天加入我們。

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.

作為今天網路廣播的一部分，我們同時展示您可以觀看的幻燈片。您可以從投資者關係網站 ir.cerus.com 存取這些投影片。

With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Vivek Jayaraman, Cerus' Chief Operating Officer; and Kevin Green, Cerus' Chief Financial Officer.

與我一起參加電話會議的有 Cerus 總裁兼執行長 Obi Greenman； Vivek Jayaraman，Cerus 營運長；和 Cerus 財務長 Kevin Green。

Cerus issued a press release today announcing our financial results for the second quarter ended June 30, 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 今天發布新聞稿，公佈了截至 2024 年 6 月 30 日的第二季財務業績，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 上取得本公告的副本。

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 commissions and product launches, product expansion prospects, and other statements that are not historical facts.

我想提醒您，我們將在這次電話會議上發表的一些聲明與未來事件和業績有關，而不是歷史事實，並且屬於前瞻性聲明。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，包括我們的2024 年產品收入指導、我們對經營現金流量和非GAAP 調整後EBITDA 業績的預期，以及我們的預期費用水準、預期未來成長和我們的成長軌跡、臨床試驗數據的可用性和相關時間、計劃的監管委員會和產品發布、產品擴展前景以及其他非歷史事實的陳述。

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 June 30, 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、績效和結果有重大差異。它們在今天的新聞稿、我們的幻燈片演示以及我們將很快提交的截至 2024 年 6 月 30 日的季度的 10-Q 表格中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 EBITDA。這些非公認會計原則措施應被視為根據公認會計原則提出的措施的補充，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調節表，請參閱今天的新聞稿和我們網站上提供的幻燈片簡報。

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，我們將首先由 Obi 致開幕詞，然後由 Vivek 討論最近的業務亮點，然後 Kevin 回顧我們的財務業績和對 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，我很高興向大家介紹 Cerus 總裁兼執行長 Obi Greenman。

Thank you, Jessica, and good afternoon, everyone.

謝謝你，潔西卡，大家下午好。

I'd like to open the call with a review of the highlights from a strong second quarter as well as our positive outlook for the duration of the year. Given the trends we have seen over the first half of this year, we are increasingly confident in our ability to meet and exceed our product revenue expectations. So we are raising our annual product revenue guidance range for the full year to $175 million to $178 million, from our previous range of $172 million to $175 million.

我想在電話會議開始時回顧一下強勁的第二季度的亮點以及我們對全年的積極前景。鑑於我們今年上半年看到的趨勢，我們對滿足並超越產品收入預期的能力越來越有信心。因此，我們將全年產品收入指引範圍從先前的 1.72 億美元至 1.75 億美元提高到 1.75 億美元至 1.78 億美元。

Our confidence stems from the growing number of blood centers and hospitals they're using INTERCEPT and the increasingly important role of pathogen inactivation across the globe. Most recently in Barcelona at the International Society of Blood Transfusion, or ISBT Congress, we are delighted to see key opinion leaders present on a broad range of topics relevant to the INTERCEPT blood system from platelets and plasma to INTERCEPT Fibrinogen Complex, and red blood cells.

我們的信心源於越來越多的血液中心和醫院正在使用 INTERCEPT 以及病原體滅活在全球範圍內日益重要的作用。最近在巴塞隆納舉行的國際輸血協會 (ISBT) 大會上，我們很高興看到關鍵意見領袖就與 INTERCEPT 血液系統相關的廣泛主題發表演講，從血小板和血漿到 INTERCEPT 纖維蛋白原複合物和紅血球。

Pathogen inactivation has become a foundational part of blood safety strategies in addition to testing and donor deferrals. We are seeing more and more members of the global transfusion medicine community recognize this and the need in the context of pandemic preparedness. One clear example is the growing threat from dengue, a transfusion-transmitted arbovirus carried by the mosquito.

除了檢測和捐贈者延期之外，病原體滅活已成為血液安全策略的基礎部分。我們看到全球輸血醫學界越來越多的成員認識到這一點以及大流行防範的必要性。一個明顯的例子是登革熱的威脅日益嚴重，登革熱是一種由蚊子攜帶的經由輸血傳播的蟲媒病毒。

Earlier this summer, both the US Centers for Disease Control and Prevention and the European Centre for Disease Prevention and Control have issued warnings about the risk -- rising risk of dengue transmission. This has implications for blood safety risks and can lead to regional donor deferral requirements, which are burdensome and limit availability. The INTERCEPT blood system proactively protects the blood supply against this virus along with many others and can be an important safeguard for the locally sustainable blood supplies.

今年夏天早些時候，美國疾病預防控制中心和歐洲疾病預防控制中心都發布了登革熱傳播風險上升的警告。這會對血液安全風險產生影響，並可能導致區域性捐贈者延期要求，這既繁瑣又限制了供應。INTERCEPT 血液系統主動保護血液供應免受這種病毒以及其他許多病毒的侵害，並且可以成為當地可持續血液供應的重要保障。

In Florida, at the moment, many platelets can still be collected locally and distributed for transfusion when treated with INTERCEPT blood system in the areas at risk for dengue transmission. To realize the benefits of a full pathogen inactivation portfolio for all transfuse blood components, we continue to advance INTERCEPT red blood cell program.

目前，在佛羅裡達州，當在有登革熱傳播風險的地區使用 INTERCEPT 血液系統進行治療時，仍然可以在當地收集許多血小板並分發用於輸血。為了實現完整的病原體滅活組合對所有輸血成分的益處，我們繼續推進 INTERCEPT 紅血球計畫。

Since our last earnings call, we've had a number of meetings with our clinical investigators and scientific advisory board members about the ReCePI Phase 3 clinical trial data and next steps. Later this fall, data from the ReCePI study will be presented at major medical meetings, including the American Society of Anesthesiology's Annual Meeting and the AABB Annual Meeting.

自上次財報電話會議以來，我們與臨床研究人員和科學顧問委員會成員就 ReCePI 3 期臨床試驗數據和後續步驟進行了多次會議。今年秋天晚些時候，ReCePI 研究的數據將在主要醫學會議上公佈，包括美國麻醉學會年會和 AABB 年會。

We continue to be encouraged by the reception with which these data have been received by cardiovascular surgery, anesthesiology, and transfusion medicine experts. We're also in the process of finalizing the ReCePI clinical trial report for submission to the FDA.

我們繼續對心血管外科、麻醉學和輸血醫學專家對這些數據的接受感到鼓舞。我們也正在最終確定 ReCePI 臨床試驗報告，以提交給 FDA。

RedeS, our second US Phase 3 clinical trial, continues to enroll. As mentioned previously, we recently opened a few more RedeS sites within the US as well as an important thalassemia trait in Turkey with the goal to finalize study enrollment by mid-2025, coincident with the initiation of the PMA modular process for an FDA approval.

RedeS，我們的第二個美國 3 期臨床試驗，繼續招募。如前所述，我們最近在美國開設了幾個 RedeS 站點，並在土耳其開設了一個重要的地中海貧血特徵，目標是在 2025 年中期之前完成研究招募，同時啟動 FDA 批准的 PMA 模組化流程。

Moving on to our new LED illuminator that we plan to submit for CE mark approval later this year, we had the opportunity to showcase the new device in our booth at the ISBT Congress in Barcelona in June. This foundational platform for future growth of the INTERCEPT business has been well received by our blood center customers and the opportunity to demo the device, so that the same operators whose input helped design the instrument, was indeed a rare gift. It was most satisfying to register their approval around the operational benefits realized, and we look forward to providing an update on our regulatory submission later this year.

接下來是我們計劃在今年稍後提交 CE 標誌批准的新型 LED 照明器，我們有機會在 6 月巴塞隆納 ISBT 大會的展位上展示該新設備。這個用於 INTERCEPT 業務未來成長的基礎平台受到了我們血液中心客戶的好評，並且有機會演示該設備，對於那些參與設計該儀器的操作員來說，確實是一份難得的禮物。我們對所實現的營運效益獲得他們的批准感到非常滿意，我們期待在今年稍後提供有關監管提交的最新資訊。

With respect to the solid financial foundation of our business, we remain committed to reaching adjusted EBITDA breakeven for the full year 2024. Kevin will provide more insight into our pathway for continued improvement in this metric over time.

考慮到我們業務的堅實財務基礎，我們仍然致力於在 2024 年全年實現調整後 EBITDA 盈虧平衡。凱文將提供更多關於我們隨著時間的推移持續改進該指標的途徑的見解。

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

我現在想將電話轉給 Vivek，討論我們 2024 年第二季的商業業績和進展，以及我們對今年下半年的展望。

Thank you, Obi, and good afternoon to everyone.

謝謝你，奧比，祝大家下午好。

As Obi mentioned, with now more than half of the year behind us, we are increasingly confident in our sales trajectory for the full year. This is fueled primarily by continued growth in our US platelet business as we have continued to increase INTERCEPT market share in this geography. As we mentioned this time last year, a key focus for our global commercial team was to return to compelling growth and ensure that we are expanding access to INTERCEPT.

正如奧比所提到的，現在已經過去一半多了，我們對全年的銷售軌跡越來越有信心。這主要得益於我們美國血小板業務的持續成長，因為我們不斷增加該地區的 INTERCEPT 市場份額。正如我們去年這個時候提到的，我們全球商業團隊的一個重點是恢復引人注目的成長，並確保我們擴大 INTERCEPT 的訪問範圍。

I am pleased to see so many geographies contributing to our strong first half 2024 growth. Of note, our Q2 performance was led by our US platelet franchise as the fundamentals of that business strengthened. INTERCEPT treated platelets remained the standard of care for platelet safety in the US. During the quarter, we saw steady growth across all customer segments.

我很高興看到如此多的地區為我們 2024 年上半年的強勁成長做出了貢獻。值得注意的是，隨著我們的美國血小板特許經營業務的基本面得到加強，我們第二季的業績表現處於領先地位。INTERCEPT 處理的血小板仍然是美國血小板安全的護理標準。在本季度，我們看到所有客戶群都實現了穩定成長。

From an overall market perspective, based on our channel check, there was a slight increase in platelet collections and underlying hospital demand for platelets. Most importantly, with each passing quarter, the volume of real world experience with INTERCEPT grows larger and both blood centers and hospitals realized the benefits of INTERCEPT that extend well beyond mitigating bacterial risk.

從整體市場來看，根據我們的管道調查，血小板採集量和醫院對血小板的潛在需求略有增加。最重要的是，隨著每個季度的過去，INTERCEPT 的實際經驗量都在增加，血液中心和醫院都意識到 INTERCEPT 的好處遠遠超出了降低細菌風險的範圍。

Moving to the international business. We are thrilled to report that, as expected, Canadian Blood Services or CBS completed implementation of INTERCEPT across its entire platelet production operation and is now at 100% pathogen inactivation. With their platelet implementation now complete, CBS' focus is turning to their intention to validate INTERCEPT for plasma. Simultaneously, the validation efforts at Héma-Québec continue to advance towards completion.

轉向國際業務。我們很高興地報告，正如預期的那樣，加拿大血液服務中心 (CBS) 在其整個血小板生產作業中完成了 INTERCEPT 實施，目前病原體已 100% 滅活。隨著血小板實施現已完成，CBS 的重點轉向了驗證血漿攔截的意圖。同時，Héma-Québec 的驗證工作繼續朝著完成的方向前進。

Beyond Canada, we saw solid growth in many international regions. As Obi referenced, we recently attended the ISBT Congress. At that meeting, the strength of our international franchise was on full display. We continue to cultivate meaningful growth opportunities in the Middle East, Latin America, and Asia-Pacific, while leveraging our 100% geographies like France and Switzerland to drive peer-to-peer educational efforts by sharing their long positive experience with pathogen reduction.

除了加拿大之外，我們在許多國際地區都看到穩健的成長。正如奧比所提到的，我們最近參加了 ISBT 大會。在那次會議上，我們的國際特許經營實力得到了充分展現。我們繼續在中東、拉丁美洲和亞太地區培育有意義的成長機會，同時利用法國和瑞士等 100% 地區的優勢，透過分享他們在減少病原體方面的長期積極經驗來推動同行教育工作。

We hosted a standing-room only symposium at ISBT and it is incredibly encouraging to see longstanding customer partners actively recruit new customers into the INTERCEPT ranks. With new technologies such as the LED Illuminator and INTERCEPT red cells on the horizon, our international markets will serve as the initial proving grounds for commercialization and customer updates. I look forward to updating you on exciting international commercial progress in the quarters to come.

我們在 ISBT 舉辦了一場僅限站立的研討會，看到長期客戶合作夥伴積極招募新客戶加入 INTERCEPT 隊伍，真是令人鼓舞。隨著 LED 照明器和 INTERCEPT 紅血球等新技術的出現，我們的國際市場將成為商業化和客戶更新的最初試驗場。我期待著向您通報未來幾季令人興奮的國際商業進展的最新情況。

Turning to INTERCEPT Fibrinogen Complex or IFC, we are pleased with the progress made over the quarter. Based on new account activation both in our direct-to-hospital business as well as via our large blood center partners, we remain confident in our annual IFC revenue guidance of $8 million to $10 million.

談到 INTERCEPT 纖維蛋白原複合物或 IFC，我們對本季的進展感到滿意。基於我們直接到醫院業務以及透過大型血液中心合作夥伴啟動的新帳戶，我們對國際金融公司 800 萬至 1000 萬美元的年度收入指導仍然充滿信心。

We made great progress in our education awareness efforts during the quarter. We are now starting to really see the benefits of our fully staffed and trained sales team. Our clinical education efforts also are bearing fruit as we are now able to share published data from hospitals that have implemented and benefited from IFC.

本季我們在教育意識方面取得了巨大進展。我們現在開始真正看到我們人員齊全且訓練有素的銷售團隊的好處。我們的臨床教育工作也取得了成果，因為我們現在能夠分享已實施並受益於 IFC 的醫院的已發布數據。

The Stanford Group's recent paper in the American Journal of Clinical Pathology describes significant improvements with IFC including a 78% reduction in overall weight and a 58% reduction in order to product issue time. Separately, in a retrospective review also published last month in transfusion, Kaiser Permanente Los Angeles Medical Center reported on its own IFC implementation in response to cryo shortages due to the pandemic. The Kaiser Group observed a 74% reduction in weight and a 70% reduction in order to issue time with IFC. As with any innovative technology, peer-to-peer education on direct experience is in value. The list of hospitals using IFC is a virtual who-too of leading institutions across several clinical departments. At this point, it is clear to us that demand for IFC is real and growing and that our hypothesis about the clinical utility and differentiation of IFC is valid.

史丹佛大學集團最近在《美國臨床病理學雜誌》上發表的論文描述了 IFC 的顯著改進，包括總重量減輕了 78%，產品發佈時間縮短了 58%。另外，在上個月發表的一份關於輸血的回顧性評論中，凱撒永久洛杉磯醫療中心報告了其自己的 IFC 實施情況，以應對大流行造成的冷凍短缺。Kaiser 集團觀察到重量減輕了 74%，並減少了 70%，以便向 IFC 發出時間。與任何創新技術一樣，基於直接經驗的同儕教育很有價值。使用 IFC 的醫院名單實際上是跨多個臨床部門的領先機構的名人錄。在這一點上，我們很清楚，對 IFC 的需求是真實且不斷增長，我們關於 IFC 的臨床效用和差異化的假設是有效的。

Our sales and marketing organizations continue to gain favorable attention at targeted scientific meetings and we are seeing a marked increase and inbound inquiries about IFC. In parallel to driving increased IFC demand, we continue to push hard to ensure growth in product supply. To that end, we are happy to announce that during the quarter, another one of our contract manufacturing blood center partners received FDA approval for its Biologics License Application or BLA.

我們的銷售和行銷組織繼續在有針對性的科學會議上獲得好評，我們看到有關 IFC 的入境詢問顯著增加。在推動國際金融公司需求增加的同時，我們持續努力確保產品供應的成長。為此，我們很高興地宣布，在本季度，我們的另一家合約製造血液中心合作夥伴的生物製品許可證申請（BLA）獲得了 FDA 批准。

At this time, we have two additional manufacturing partners with BLA still under review by the FDA, which upon approval, will increase IFC capacity even further. Furthermore, as more hospitals express interest in IFC, we are starting to field requests from new blood centers on how to produce IFC.

目前，我們還有另外兩家製造合作夥伴，其 BLA 仍在接受 FDA 的審查，一旦獲得批准，將進一步提高 IFC 的產能。此外，隨著越來越多的醫院對 IFC 表現出興趣，我們開始回應新血液中心關於如何生產 IFC 的請求。

Our progress in Q2 deepens our confidence in the IFC franchise and most importantly, we are hearing directly from physicians that we are providing a product that materially improves their ability to care for their patients. I look forward to providing more updates on our progress with IFC in future quarters.

我們第二季度的進展加深了我們對 IFC 特許經營權的信心，最重要的是，我們直接從醫生那裡聽到我們正在提供一種產品，可以極大地提高他們護理患者的能力。我期待在未來幾季提供有關我們與國際金融公司合作進展的更多最新資訊。

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

我現在將把電話轉給凱文，以審查我們的財務表現。

Thanks, Vivek. Good afternoon and thank you all for joining us.

謝謝，維韋克。下午好，感謝大家加入我們。

On today's call, I'll be discussing our financial results for the second quarter of 2024 along with commentary on how those results and our financial outlook for the remainder of 2024, compared to the plan we communicated earlier this year.

在今天的電話會議上，我將討論我們 2024 年第二季度的財務業績，並評論這些業績以及我們對 2024 年剩餘時間的財務前景與我們今年早些時候傳達的計劃相比的情況。

To start, we posted product revenue of $45.1 million in the second quarter of 2024. This represents year-over-year growth of 16% and brings the first half revenue to $83.4 million, up 20% from the first half of last year.

首先，我們公佈 2024 年第二季的產品收入為 4,510 萬美元。這意味著年增 16%，上半年營收達到 8,340 萬美元，比去年上半年成長 20%。

North American platelet sales were the major contributor to our product revenue growth during the quarter. In the US, second quarter 2024 product revenues exceeded prior year levels by 19%. As we anticipated, sales to Canadian Blood Services were also extremely strong and reached 100% across their entire platelet production operation during the quarter.

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 年第二季產品營收比去年同期成長 19%。正如我們預期的那樣，加拿大血液服務公司的銷售也非常強勁，本季整個血小板生產業務的銷售量達到 100%。

In EMEA, second quarter product revenues were up slightly year over year and up 8% compared to the first quarter of 2024. Year over year, FX rates were a slight headwind for the UK business of around 1%.

在歐洲、中東和非洲地區，第二季產品營收年比小幅成長，與 2024 年第一季相比成長 8%。與去年同期相比，匯率對英國業務來說是一個輕微的阻力，約為 1%。

Also for Q2, we posted IFC product revenue of $2 million, up from $1.4 million in the prior year period, driven by both the addition of new hospital users as well as increased adoption of existing hospitals. As Vivek mentioned in his comments, expanding clinician experience with the utility of IFC in massive hemorrhage has been and will continue to be key to IFC's growth trajectory.

同樣在第二季度，我們公佈的 IFC 產品收入為 200 萬美元，高於去年同期的 140 萬美元，這主要是由於新醫院用戶的增加以及現有醫院的採用率增加所致。正如 Vivek 在評論中提到的那樣，擴大臨床醫生在大出血中使用 IFC 的經驗已經並將繼續成為 IFC 成長軌蹟的關鍵。

In addition to our product revenue and not included in our guidance, government contract revenue totaled $5.4 million in Q2, compared to $8.9 million for the prior year period. The completion of our US Phase 3 ReCePI clinical trial was the primary driver for the decline. We now expect our Turkish site to begin enrolling patients in the next few months. As that happens, we expect a modest uptick in government contract revenue.

除了我們的產品收入（未包含在我們的指導中）之外，第二季度的政府合約收入總計 540 萬美元，而去年同期為 890 萬美元。我們美國 3 期 ReCePI 臨床試驗的完成是下降的主要驅動力。我們現在預計我們的土耳其網站將在未來幾個月內開始招募患者。當這種情況發生時，我們預計政府合約收入將小幅增長。

As a reminder, included in our government contract are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further whole blood pathogen reductions and our milestone based agreement with the US Department of Defense for lyophilized IFC.

提醒一下，我們的政府合約中包括根據我們與 BARDA 的合約確認為報銷的收入、我們與 FDA 就進一步減少全血病原體達成的協議以及我們與美國國防部就凍乾 IFC 達成的基於里程碑的協議。

Turning now to our product gross profit and gross margins. Our second quarter product gross profit was $24.7 million, compared to $21.3 million during the prior year period, an increase of 16% year over year. Product gross margins for the second quarter were 54.7%, relatively stable when compared to both the prior year and Q1 2024. Absent any unanticipated factor, we continue to expect that gross margins will remain close to Q2 levels for the balance of the year.

現在談談我們的產品毛利和毛利率。我們第二季的產品毛利為 2,470 萬美元，去年同期為 2,130 萬美元，較去年同期成長 16%。第二季產品毛利率為 54.7%，與前一年和 2024 年第一季相比相對穩定。如果沒有任何意外因素，我們繼續預計今年剩餘時間的毛利率將保持接近第二季的水平。

Moving on, our second quarter operating expenses, which totaled $33.9 million, were $8 million lower than the $41.9 million the prior year, a year-over-year decline of 19%. Without the impact of the $2.1 million June 2023 restructuring charge, operating expenses were $5.8 million lower or 15% when comparing the June 2024 quarter to the prior year. Q2 2024 operating expenses included $5.8 million in non-cash stock-based compensation.

接下來，我們第二季的營運支出總計 3,390 萬美元，比上年同期的 4,190 萬美元減少了 800 萬美元，年減 19%。如果不考慮 2023 年 6 月 210 萬美元重組費用的影響，2024 年 6 月季度與前一年相比，營運費用減少 580 萬美元，即減少 15%。2024 年第二季營運費用包括 580 萬美元的非現金股票薪酬。

By specific expense type, second quarter R&D expenses totaled $15 million, compared to $19.2 million during the prior year period. Similar to our Q1 results, this 22% decline was driven primarily by the completion of the ReCePI clinical trial and the effects of the restructuring implemented in June of last year.

以具體費用類型劃分，第二季研發費用總計 1,500 萬美元，而去年同期為 1,920 萬美元。與我們第一季的結果類似，這項 22% 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所致。

Second quarter SG&A expenses were $19 million, compared to $20.5 m,illion during the prior year period. The decline again driven by last year's restructuring. We do not anticipate significant swings in SG&A for the remainder of 2024 and anticipate continued leverage from our SG&A investments.

第二季銷售、管理及行政費用為 1,900 萬美元，去年同期為 2,050 萬美元。去年的重組再次推動了這一下降。我們預計 2024 年剩餘時間內 SG&A 不會出現重大波動，並預計我們的 SG&A 投資將繼續發揮槓桿作用。

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 three months ended June 30, 2024, improved significantly when compared to the same period in the prior year.

現在讓我們專注於淨利潤和非 GAAP 調整後 EBITDA 結果。整體而言，截至 2024 年 6 月 30 日止三個月，Cerus 報告的淨虧損與去年同期相比顯著改善。

Net loss attributable to Cerus for Q2 narrowed by 56% to $5.8 million or $0.03 per diluted share, compared to $13.3 million or $0.07 per diluted share for the prior year period. The net loss for Q2 of this year approximates our non-cash stock-based compensation mentioned previously.

第二季 Cerus 淨虧損收窄 56%，至 580 萬美元，即稀釋後每股 0.03 美元，去年同期為 1,330 萬美元，即稀釋後每股 0.07 美元。今年第二季的淨虧損與我們之前提到的非現金股票補償大致相當。

On a non-GAAP adjusted EBITDA basis, Q2 2024 generated positive adjusted EBITDA of just under $1 million, compared to a loss of $4.7 million for the prior year period. We're pleased with the adjusted EBITDA result and remain steadfast in our commitment to deliver a positive adjusted EBITDA result for 2024 as a whole.

在非 GAAP 調整後 EBITDA 基礎上，2024 年第二季的調整後 EBITDA 為正，接近 100 萬美元，而去年同期為虧損 470 萬美元。我們對調整後的 EBITDA 結果感到滿意，並堅定地致力於在 2024 年全年實現積極的調整後 EBITDA 結果。

As we look ahead, the second half growth contemplated in our revised guidance, a continued focus on generating leverage from our operating expenses and stable gross margins are all expected to contribute to the anticipated achievement of our goal.

展望未來，我們修訂後的指引中考慮的下半年增長、繼續關注從營運支出中產生槓桿作用以及穩定的毛利率都預計將有助於我們目標的預期實現。

On the balance sheet and associated cash flows, we ended the second quarter with a cash position of $71.2 million of cash, cash equivalents, and short-term investments on the balance sheet. It's important to note that the amount drawn on our revolving letter of credit declined from Q1 levels by $1.2 million, suggesting that our reported cash balance at June 30 could have been even stronger.

在資產負債表和相關現金流方面，第二季結束時，我們資產負債表上的現金、現金等價物和短期投資的現金部位為 7,120 萬美元。值得注意的是，我們的循環信用證提取金額較第一季水準下降了 120 萬美元，這表明我們截至 6 月 30 日報告的現金餘額可能會更加強勁。

At the beginning of the year, we foreshadowed that not only was achieving a positive adjusted EBITDA goal, but that we could possibly generate positive operating cash flows. (inaudible) we delivered a positive operating cash flow of $0.4 million for the second quarter, compared to cash used from operations of $7.6 million during the prior year period.

今年年初，我們預示著我們不僅能夠實現正的調整後 EBITDA 目標，而且還可能產生正的營運現金流。 （聽不清楚）第二季我們實現了 40 萬美元的正營運現金流，而去年同期營運所用現金為 760 萬美元。

While we aren't providing formal guidance on cash flows for 2024, we are keenly focused on continued improvement of our bottom line results and tight management of working capital, which combined, could provide us with the components necessary to report positive operating cash flows in subsequent periods.

雖然我們沒有提供有關2024 年現金流的正式指引，但我們非常關注持續改善我們的盈利結果和嚴格的營運資本管理，這兩者相結合，可以為我們提供在2024 年報告正運營現金流所需的要素。

Turning now to our guidance. As both Obi and Vivek described, we are increasingly confident in our growth expectations and as such, we are raising our full year 2024 product revenue guidance to the range of $175 million to $178 million from our prior guidance range of $172 million to $175 million. We are 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.

現在轉向我們的指導。正如 Obi 和 Vivek 所描述的，我們對成長預期越來越有信心，因此，我們將 2024 年全年產品收入指引從先前的 1.72 億美元到 1.75 億美元提高到 1.75 億美元到 1.78 億美元。我們重申對 IFC 的 2024 年全年收入指引，我們仍然預計該收入將在 800 萬至 1000 萬美元之間。

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

至此，我現在想將電話轉回給奧比致結束語。

Thank you, Kevin.

謝謝你，凱文。

The Cerus team continues to advance the INTERCEPT blood system in many markets and is looking forward to the potential product approvals in the year ahead. The focused geographic expansion of our commercial effort, combined with the growing IFC business, is providing for increased confidence in how we continue to ramp penetration and increase revenue.

Cerus 團隊繼續在許多市場推進 INTERCEPT 血液系統，並期待未來一年潛在的產品批准。我們商業努力的重點地域擴張，加上不斷成長的國際金融公司業務，增強了我們對如何繼續提高滲透率和增加收入的信心。

Particularly in the case of IFC, the many positive case studies of routine use now coming from hospitals across the US are validating the target product profile that we developed for IFC to address an unmet clinical need. Our safe and readily available Fibrinogen Complex product that is easy to use by the hospital transfusion service staff has found its place within hospitals and their anesthesiology and surgery teams.

特別是就 IFC 而言，來自美國各地醫院的許多常規使用的積極案例研究正在驗證我們為 IFC 開發的目標產品概況，以解決未滿足的臨床需求。我們安全且易於使用的纖維蛋白原複合物產品易於醫院輸血服務人員使用，已在醫院及其麻醉科和手術團隊中找到了一席之地。

Our leadership team recently sat down to review where we have been, where we are, and where we're going. There's so much detail and complexity in our history that it's often easy to overlook the key achievements and what Cerus has evolved to from where it began. With INTERCEPT increasingly becoming the standard of care in multiple countries across the globe, we are committed to achieving our adjusted EBITDA targets to enable the self-funding of our product portfolio and continued geographic expansion that will allow us to realize our important mission as a company.

我們的領導團隊最近坐下來回顧了我們的過去、現在和未來。我們的歷史中有如此多的細節和複雜性，以至於我們常常很容易忽略關鍵成就以及 Cerus 從最初的發展到現在的發展歷程。隨著 INTERCEPT 日益成為全球多個國家的護理標準，我們致力於實現調整後的 EBITDA 目標，以實現我們產品組合的自籌資金和持續的地理擴張，從而使我們能夠實現作為一家公司的重要使命。

Thank you for your continued interest in Cerus. I will now turn the call over to the operator for questions.

感謝您對 Cerus 的持續關注。我現在將把電話轉給接線員詢問問題。

(Operator Instructions)

（操作員說明）

Ross Osborn, Cantor Fitzgerald.

羅斯·奧斯本，康托·菲茨杰拉德。

Hey guys, thanks for taking questions and congrats on the strong results.

嘿夥計們，感謝您提出問題並祝賀我們取得了優異的成績。

Starting off, I would be curious to hear if you saw any rebuilding of inventory following your extended shelf life. As a follow-up, where do you stand on further examining platelet shelf life?

首先，我很想知道您是否看到在延長保質期後庫存有所重建。作為後續行動，您對進一步檢查血小板保質期有何看法？

Thanks, Ross. Vivek, would you mind taking this?

謝謝，羅斯。維韋克，你介意拿這個嗎？

Sure, no problem.

當然，沒問題。

We in terms of extending shelf life, we anticipate filing later this year for the 18-month shelf life, so to get back to where we were prior to the dating issues. And in the quarter, we didn't see any significant rebuilding of inventories. What we continue to see driving underlying growth was really just INTERCEPT (technical difficulty) distributed products, so there was not any material inventory rebuild at the customer level in the second quarter.

在延長保質期方面，我們預計在今年稍後提交 18 個月保質期的申請，以便回到日期問題之前的狀態。在本季度，我們沒有看到庫存出現任何重大重建。我們繼續看到推動潛在成長的實際上只是攔截（技術難度）分散式產品，因此第二季度在客戶層面沒有任何材料庫存重建。

Okay. Got it.

好的。知道了。

And then looking at Héma-Québec, could you provide some more color on exactly where they stand in the validation process and when we could start to see some incremental revenue from them?

然後看看 Héma-Québec，您能否提供更多資訊來說明他們在驗證過程中的確切位置以及我們何時可以開始看到他們帶來的一些增量收入？

Sure. So their validation is effectively complete. They are going to follow a path that's similar to what happened with Canadian Blood Services where they'll have a small portion of their overall inventory that's pathogen reduced, and then upon successful completion of that trial phase move towards full implementation. So we're anticipating that initial piece of their inventory to be passed and reduced in calendar year 2025 with 2026 being the year where we go towards full implementation.

當然。所以他們的驗證其實已經完成。他們將遵循與加拿大血液服務中心類似的路徑，減少其整體庫存中的一小部分病原體，然後在成功完成試驗階段後轉向全面實施。因此，我們預計他們的初始庫存將在 2025 年通過並減少，而 2026 年將是我們全面實施的一年。

Great. Thanks for taking our questions, and congrats again on the results.

偉大的。感謝您提出我們的問題，並再次祝賀我們的結果。

Jacob Johnson, Stephens.

雅各約翰遜、史蒂芬斯。

Heys, good afternoon. And I'll add my congrats on the quarter.

嘿嘿，下午好。我將對本季表示祝賀。

And maybe starting with the highlight of the quarter, just the positive EBITDA we saw in the quarter. Kevin, as we think about the back half of the year, I know you're talking about breakeven for the fiscal year, but presumably we should see revenues up in the back half of this year. Is there any way or any reason why we wouldn't see better revenue in the back half continue this trend of positive EBITDA that you saw in 2Q?

也許從本季度的亮點開始，我們在本季度看到了積極的 EBITDA。凱文，當我們考慮今年下半年時，我知道您正在談論本財年的盈虧平衡，但想必我們應該會看到今年下半年的收入成長。是否有任何方式或任何原因導致我們不會看到下半年更好的收入延續第二季度的正 EBITDA 趨勢？

Yeah. Thanks. You're absolutely right as our guidance suggests, we do expect pretty strong growth in the back half of the year. In addition, and as stated in our prepared remarks, we do expect fairly stable gross margins for the balance of the year and continue to expect that we'll get increasing leverage from our operating expenses. So all three of those suggest strength on the non-GAAP adjusted EBITDA results for the back half of the year and give us a lot of confidence in our statements that will achieve our goal.

是的。謝謝。正如我們的指導意見所表明的那樣，您是完全正確的，我們確實預計今年下半年將出現相當強勁的增長。此外，正如我們在準備好的評論中所述，我們確實預計今年剩餘時間的毛利率將相當穩定，並繼續預計我們將從營運支出中獲得越來越多的槓桿。因此，這三項都表明今年下半年非公認會計原則調整後的 EBITDA 業績強勁，並使我們對實現我們目標的聲明充滿信心。

Got it. Thanks for that, Kevin.

知道了。謝謝你，凱文。

And then maybe for Vivek. On IFC, I heard you mention a couple things. Just as we think about the growth outlook for that product line, I'm curious about how much of an opportunity there is from expanding within your current hospital customers that you're in today and doing more with them. How impactful could new hospital wins be? And then I'm just curious too, on the capacity side, it sounds like some more blood centers to come online. Is that something that's maybe constraining you, in particular geographies? If you could unpack some of those dynamics.

然後也許是維韋克。在國際金融公司，我聽到你提到了幾件事。正如我們思考該產品線的成長前景一樣，我很好奇在目前的醫院客戶中進行擴展並與他們一起做更多事情會帶來多少機會。新醫院獲勝的影響力有多大？然後我也很好奇，在容量方面，聽起來會有更多的血液中心上線。這是否可能限制您，特別是在特定地區？如果你能解開其中一些動態的話。

Thanks.

謝謝。

Yeah, sure. I'd be happy to, and certainly pleased follow-up if you require more clarification.

是的，當然。如果您需要更多說明，我很樂意，當然也很樂意跟進。

So starting with growth from depth with existing customers as opposed to growth with new de novo customers, there's significant opportunity in both. We're just starting to get our first handful of customers that are fully 100% converted to IFC. So same-store sales, if I can express it that way, provides meaningful opportunity for growth.

因此，從現有客戶的深度成長開始，而不是從頭開始成長新客戶，兩者都存在著巨大的機會。我們剛開始吸引第一批 100% 完全轉向 IFC 的客戶。因此，如果我可以這樣表達的話，同店銷售提供了有意義的成長機會。

But we're really early days in terms of customer acquisition. So the fact is that vast majority of candidate hospitals to use IFC that haven't started yet is larger than our current user base. So we're -- it's really a both and approach in terms of maintaining sustained growth. We are seeing a marked increase in demand. And as we've talked about in prior calls, we're always looking to make sure that supply stays ahead of demand, not too far out front of it, but such that it's sufficient supply, so that we don't have to worry about constraining customers.

但就客戶獲取而言，我們確實還處於早期階段。所以事實是，絕大多數尚未開始使用 IFC 的候選醫院都比我們目前的用戶群還要大。因此，就保持持續成長而言，這確實是一種兼而有之的方法。我們看到需求顯著增加。正如我們在之前的電話會議中談到的那樣，我們始終希望確保供應保持領先於需求，不是超出需求太多，而是供應充足，這樣我們就不必擔心關於限制客戶。

And we now have four blood center production partners who receive BLA, so they can transport product across state lines. We're anticipating two more BLAs here in the very near future. And that combined production capacity supported by the BLAs, we believe, provides sufficient volume to support our growth expectations both through the balance of the year and through 2025. We'll continue to monitor and track that closely.

我們現在有四個血液中心生產合作夥伴接收 BLA，因此他們可以跨州運輸產品。我們預計在不久的將來還會有兩個 BLA。我們相信，BLA 支援的綜合產能將提供足夠的產量來支持我們今年剩餘時間和 2025 年的成長預期。我們將繼續密切監視和追蹤。

The other thing that's encouraging, and I think I mentioned it earlier is that we're seeing blood centers, we're receiving inbound inquiries from blood centers who are hearing from their key hospital customers that they want to try and see, and they're keen to be the producers who provide them that product. So I anticipate over the near and mid-term we're going to see a pretty significant step up in terms of number of production partners. So on balance, it's still early days, but we're really encouraged principally by the clinical value and utility of IFC and the fact that physicians are, in fact, validating our value proposition.

另一件令人鼓舞的事情，我想我之前提到過，我們正在拜訪血液中心，我們正在收到來自血液中心的入站詢問，這些中心從他們的主要醫院客戶那裡聽到他們想要嘗試看看，並且他們'我們熱衷於成為向他們提供該產品的生產商。因此，我預計在近期和中期，我們將看到生產合作夥伴數量的顯著增加。因此，總的來說，現在還處於早期階段，但我們確實受到鼓舞，主要是因為 IFC 的臨床價值和實用性，以及醫生實際上正在驗證我們的價值主張。

Sounds like a bunch of white space. Good luck with that, Vivek, and thanks for taking the questions.

聽起來像是一堆空白。祝你好運，Vivek，並感謝您提出問題。

Josh Jennings, TD Cowen.

喬許·詹寧斯，TD·考恩。

Hi guys, this is Eric on for Josh. Thank you for taking the question.

大家好，我是艾瑞克（Eric）為喬許（Josh）代言。感謝您提出問題。

As a follow-up on IFC there, congratulations on the progress. If I could -- I was just wondering if you could lay out roadmap of how you're thinking about growth for IFC in '25. I think the Street has total Cerus sales at the [190 to 200] ballpark. Could IFC be 10% of sales next year? Is that you think a good starting point? Just curious with all the growth here.

作為國際金融公司的後續行動，祝賀所取得的進展。如果可以的話，我只是想知道您是否可以製定路線圖，說明您如何考慮 IFC 在 25 年的成長。我認為該街的 Cerus 銷售總額在 [190 到 200] 球場上。IFC 能否佔明年銷售額的 10%？您認為這是一個好的起點嗎？只是對這裡的所有增長感到好奇。

Thanks.

謝謝。

Kevin, I'll (technical difficulty) defer to you in terms of quantifying the number. I certainly know the expectations we [have in the event].

凱文，我會（技術難度）在量化數字方面聽從你的意見。我當然知道我們的期望[有事件發生]。

Well, I mean, clearly we're not providing guidance for 2025 here, but I think you can speak to the growth opportunity that's in front of us and calibrate our range. Obviously, we're guiding Eric, as you know, $8 million to $10 million for this year. And there is, as we just discussed a lot of white space in front of us. Anything else you'd add, Vivek?

嗯，我的意思是，顯然我們不會在這裡提供 2025 年的指導，但我認為您可以談論我們面前的成長機會並調整我們的範圍。顯然，如您所知，我們今年將為艾瑞克提供 800 萬至 1000 萬美元的指導。正如我們剛剛討論的那樣，我們面前有很多空白。維韋克，你還有什麼要補充的嗎？

No. I mean, once we get to 2025 numbers here in future quarters, I think that's a rough rule of thumb. I think that percentage is probably in range we've got. The key focus for us has been as we support demand with increased supply and capacity, really working closely with our blood center production partners to ensure that they can produce sufficient volume that allows us to really push on the demand piece and grow unconstrained.

不。我的意思是，一旦我們在未來幾季達到 2025 年的數字，我認為這是一個粗略的經驗法則。我認為這個百分比可能在我們現有的範圍內。我們的重點是透過增加供應和產能來支持需求，真正與我們的血液中心生產合作夥伴密切合作，確保他們能夠生產足夠的產量，使我們能夠真正推動需求並不受限制地成長。

And we feel confident that we're putting the building blocks in place to be able to do that. The peer-to-peer interaction has really ramped up in the last quarter. And we anticipate as we get through the summer and into the fall conference season, we're going to have many more opportunities to share the -- with the single center and then the developing clinical evidence we're getting and we anticipate that we'll start to drive more demand as well.

我們相信我們正在為實現這一目標奠定基礎。上個季度，點對點互動確實增加。我們預計，隨著夏季的到來和秋季會議季的到來，我們將有更多的機會與單一中心分享，然後我們正在獲得不斷發展的臨床證據，我們預計我們’也將開始推動更多需求。

And now we're -- we have a fully trained and staff sales organization who cultivated existing customers. So a lot of the investments, a lot of the things that we had put into place are really now starting to bear fruit. And so we anticipate that IFC not just for '25 but really for the next few years will be a meaningful contributor to allowing us to continue to grow, to drive compelling growth on the top-line.

現在，我們擁有一支訓練有素、員工齊全的銷售組織，他們培養了現有客戶。因此，我們所做的許多投資、很多事情現在確實開始有成果。因此，我們預計，國際金融公司不僅在 25 年，而且在未來幾年，都將成為有意義的貢獻者，使我們能夠繼續發展，推動收入的引人注目的成長。

And just if I could, I'd be remiss if I didn't say that we expect that growth to be largely leverageable, right? So not all the hot of incremental investments that Vivek just mentioned that we've made those in the past and then how bearing fruit. So I think that bodes well for the bottom line impact as well.

如果我可以的話，如果我沒有說我們預計成長在很大程度上是可以利用的，那就是我的失職，對嗎？因此，維韋克剛才提到的增量投資並不是所有熱門項目，我們過去已經進行過這些投資，然後如何取得成果。因此，我認為這對利潤影響也是一個好兆頭。

Understood. That makes sense.

明白了。這是有道理的。

And for the INTERCEPT red blood cell program, I was hoping to hear an update on your progress in the EU there. Just what are the remaining steps between where we stand now and a potential clearance? I think last quarter you mentioned that you guys had completed -- a complete response with the notified body. I was just wondering what the update is there.

對於攔截紅血球計劃，我希望聽到您在歐盟的最新進展。從我們現在的處境到可能獲得許可，還需要採取哪些步驟？我想上個季度您提到你們已經完成了與公告機構的完整回應。我只是想知道更新了什麼。

Thank you.

謝謝。

Yeah, Eric. So just to remind you and others about the process, so we -- I have -- we still have to hear back from our competent authority, which is the CBG-MEB based out of the Netherlands. We still have not heard back from them yet. And it may be due to the summer holidays, so we do expect to hear something after the European holidays are over, so possibly before the end of the quarter.

是的，埃里克。因此，只是想提醒您和其他人有關該流程的信息，所以我們——我——我們仍然需要收到我們主管當局（即位於荷蘭的 CBG-MEB）的回复。我們還沒有收到他們的回覆。這可能是由於暑假的緣故，所以我們確實預計在歐洲假期結束後（可能是在本季結束之前）聽到一些消息。

And then once they get back to us with their definitive opinion, then it goes back to our notified body, which is TUV, and then that moves on to an approval decision. So I think at this point in time, its -- we're still waiting for the CBG-MEB response. But as you mentioned, we did feel like we provided a complete response to their questions earlier in the year.

然後，一旦他們向我們反饋明確的意見，就會返回我們的公告機構，即 TUV，然後做出批准決定。所以我認為目前，我們仍在等待 CBG-MEB 的回應。但正如您所提到的，我們確實覺得我們在今年早些時候對他們的問題提供了完整的答案。

(Operator Instructions)

（操作員說明）

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey guys, this is Vidyun on for Mark. Thanks for taking the questions.

大家好，我是 Mark 的 Vidyun。感謝您提出問題。

To understand that the business is stabilizing here off of 2023 and returning to growth, just how are you thinking about sources of upside to the 2024 guide? Just any additional variables to consider like restocking inventory or recovery of platelet donors.

要了解該業務在 2023 年後將趨於穩定並恢復成長，您如何看待 2024 年指南的上行來源？只需要考慮任何其他變量，例如補充庫存或恢復血小板捐贈者。

Thanks.

謝謝。

Thanks, Vidyun. Vivek, would you like to handle this one as well?

謝謝，維迪雲。Vivek，你也想處理這個嗎？

Sure, I'd be happy to.

當然，我很樂意。

So in terms of how our outlook for the full year and our confidence underpinning the raise in full year guidance. So we are not currently forecasting any rebuild of customer level inventory to be a driver of the revenue upside. We want to make sure that we can maintain healthy safety stock at our customers, but we're not anticipating an inventory rebuild at this time. It's a one-time revenue driver.

因此，就我們對全年的展望以及我們對全年指引上調的信心而言。因此，我們目前預期客戶級庫存的重建不會成為營收成長的驅動力。我們希望確保我們能夠為客戶維持健康的安全庫存，但我們目前預計不會重建庫存。這是一次性的收入驅動因素。

We are seeing signals of a stabilizing collection and utilization market, so increased hospital demand for platelets and then some stabilization at the blood center level in terms of collections. But what's really driving the growth is a continued enthusiasm for an adoption of the INTERCEPT platelets and our ability to see those products produced and ultimately distributed to hospitals, so.

我們看到了收集和利用市場穩定的訊號，因此醫院對血小板的需求增加，然後血液中心在採集方面有所穩定。但真正推動成長的是對採用 INTERCEPT 血小板的持續熱情以及我們看到這些產品生產並最終分發到醫院的能力。

And then in addition, as we talked about in some of the prior questions, the demand on the IFC side continues to grow, and in parallel, our ability through our production partners to produce supply is growing as well. So we see continued growth in the IFC franchise in the second half of the year. So it's really the combination of those factors that give us confidence in our ability to continue to see top-line progress.

此外，正如我們在之前的一些問題中談到的那樣，國際金融公司方面的需求持續增長，同時，我們透過生產合作夥伴生產供應的能力也在增長。因此，我們看到國際金融公司的特許經營權在今年下半年將持續成長。因此，正是這些因素的結合讓我們對繼續實現營收成長的能力充滿信心。

Perfect. Understood.

完美的。明白了。

And then I think I heard you guys briefly touch a little bit on the next-gen illuminator. So could you just help us think about some of the features and help us quantify the planned improvements there? And if you could also remind us what the thinking is on -- in terms of timing of the regulatory submissions.

然後我想我聽到你們簡要介紹了下一代照明器。那麼您能否幫助我們考慮一些功能並幫助我們量化計劃中的改進？您是否也能提醒我們在監管提交的時間方面的想法是什麼。

Yeah. Thanks, Vidyun.

是的。謝謝，維迪雲。

So one of the key things we are trying to achieve with the next-gen [illuminator], we call it INT-200 is that it just would increase the operational ease of use for blood center customers and also reduce the space that they needed because a lot of these blood centers are very space constrained. So right now, the current illuminator, the INT-100 will take some space of three INT-200. So it really is a space saver for these blood centers.

因此，我們試圖透過下一代[照明器]（我們稱之為 INT-200）實現的關鍵目標之一是，它只會提高血液中心客戶的操作易用性，並減少他們所需的空間，因為許多血液中心的空間都非常有限。因此，目前的照明器 INT-100 將佔用三個 INT-200 的空間。因此，它確實為這些血液中心節省了空間。

But it's also a lot easier to use with regard to the graphical user interface and just the reliability of the system. So as I mentioned in the prepared remarks, we're really happy to see the feedback from customers at ISBT in Barcelona. It was the customers who we engaged early on in the development of this device and they were really happy with how their feedback led to this final result.

但就圖形使用者介面和系統可靠性而言，它也更容易使用。正如我在準備好的演講中提到的，我們非常高興看到巴塞隆納 ISBT 客戶的回饋。我們早期就參與了該設備的開發，他們對自己的回饋導致最終結果感到非常滿意。

We are looking to file for approval here in the relatively near term, and it's roughly going to be about 180-day review cycle for CE mark approval in Europe, so that product we expect to launch in 2025.

我們希望在近期內申請批准，歐洲 CE 標誌批准的審查週期大致為 180 天左右，因此我們預計該產品將於 2025 年推出。

William Bonello, Craig-Hallum Capital Group.

威廉·博內羅，克雷格-哈勒姆資本集團。

Hey guys, just wondering if you can give an update on international and any pending opportunities outside of North America.

嘿夥計們，只是想知道您是否可以提供有關國際和北美以外任何待定機會的最新信息。

Yeah. Thanks, Bill. Vivek, would you mind taking this as well?

是的。謝謝，比爾。維韋克，你介意也拿這個嗎？

Sure, happy to.

當然，很高興。

So we have, and I think we've talked about this previously, but we continue to make good progress on our joint venture in China. We anticipate learning by the end of this year whether or not there'll be a need for a local clinical study. But the underlying clinical demand and interest in INTERCEPT remains quite high in that geography. So that will be -- that's a fantastic growth opportunity for us really materializing towards the back part of this decade.

所以我們已經這樣做了，我想我們之前已經討論過這個問題，但我們在中國的合資企業繼續取得良好進展。我們預計將在今年年底前了解是否需要進行本地臨床研究。但該地區對 INTERCEPT 的潛在臨床需求和興趣仍然相當高。因此，這對我們來說是一個絕佳的成長機會，將在本十年的後半段真正實現。

Similarly, the strong distributor partner in the Middle East, there's a significant push towards healthcare investment in the Kingdom of Saudi Arabia and we're seeing strong growth there. And a lot of practice patterns in the Middle East here what happens in the US since the -- they fall the ABB FDA standards. And then we continue the single largest unit opportunity in Western Europe is Germany. And what's encouraging there is the largest blood centers and hospitals are going through the marketing authorization and marketing the regulatory process. So those are three snapshot examples of geographies where we think can drive significant international growth.

同樣，中東地區強大的分銷合作夥伴沙烏地阿拉伯王國大力推動醫療保健投資，我們看到那裡的強勁成長。中東地區的許多實踐模式與美國以來發生的情況相同——它們不符合 ABB FDA 標準。然後我們繼續說西歐最大的單一單位機會是德國。令人鼓舞的是，最大的血液中心和醫院正在辦理行銷授權和行銷監管流程。這些是我們認為可以推動顯著國際成長的地區的三個快照範例。

We have a strong team on the ground in EMEA and they really have been executing well through the first half of this year. So the international franchise certainly is a significant component of our future growth plans. It's also going to be the initial commercial geography for the products in our pipeline. So it's where we'll introduce the LED Illuminator first as well as INTERCEPT red cell. So really continues to be a valuable part of our franchise.

我們在歐洲、中東和非洲地區擁有一支強大的團隊，他們在今年上半年的表現確實非常出色。因此，國際特許經營無疑是我們未來成長計畫的重要組成部分。這也將成為我們管道產品的最初商業地理。因此，我們將首先介紹 LED 照明器以及攔截紅血球。因此，它確實仍然是我們特許經營的重要組成部分。

And when you think about some of those opportunities and as you start to look out to next year and you think about the magnitude, I mean, are these the kinds of things that could actually drive an accelerating growth rate for you? Or do you look at it as more no, we have to add some of these big old non-North American clients to just keep up with the growth that we got out of adding Canada and whatnot over the past couple of years?

當你想到其中一些機會，當你開始展望明年並考慮其規模時，我的意思是，這些機會實際上可以推動你加速成長嗎？或者您認為更不，我們必須增加一些大型非北美老客戶才能跟上過去幾年我們因增加加拿大等而獲得的成長？

It's a little bit of both, candidly because part of it is a function of the size of the geographic opportunity and the potential ramp. If you look in our history, you have some geographies that are significantly sized, but they have more of vulcanized customer base, and so it takes a while to get on Board. Other countries that have significant volume have a single decision maker, and once they decide to go, then it really becomes about operations and partnering with our deployment organization.

坦白說，兩者都有一點，因為其中一部分是地理機會大小和潛在增長的函數。如果你回顧我們的歷史，你會發現有些地區規模很大，但他們擁有更多的固化客戶群，因此需要一段時間才能加入。其他擁有大量數量的國家只有一個決策者，一旦他們決定離開，那麼真正的問題就變成了營運以及與我們的部署組織的合作。

And in those geographies I mentioned, there's a mix of both customer types, but part of it is who goes when and how quickly we can ramp up. That's why in parallel, I mentioned -- I referenced it in the context of IFC, but also across our platelet franchise, we're trying to make sure that we have sufficient supply to stay ahead of demand.

在我提到的那些地區，兩種客戶類型混合存在，但其中一部分是誰在何時以及我們能夠以多快的速度增加。這就是為什麼我同時提到——我在國際金融公司的背景下提到了這一點，而且在我們的血小板特許經營權中，我們正在努力確保我們有足夠的供應來保持領先於需求。

But I think you're going to see certainly in the US, the IFC franchise is a significant growth opportunity. But internationally, some of these geographies that they come on, it's not merely maintaining our growth rate, but if they go well, we could certainly see some upside there.

但我認為您肯定會在美國看到國際金融公司的特許經營權是一個重要的成長機會。但在國際上，他們出現的一些地區不僅維持了我們的成長率，而且如果進展順利，我們肯定會看到那裡的一些好處。

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

謝謝。我現在想將電話轉回給奧比·格林曼，請他發表結束語。

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 through quarterly calls and upcoming investor conferences.

好吧，再次感謝您今天加入我們以及您對 Cerus 的興趣。我們期待透過季度電話會議和即將舉行的投資者會議，讓您隨時了解我們在 2024 年剩餘時間內的進展。

Thanks very much.

非常感謝。

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。