Cerus Corp (CERS) 2024 Q3 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Cerus Corporation third-quarter 2024 earnings conference call. (Operator Instructions) Please be advised today's conference is being recorded.

美好的一天，女士們先生們。謝謝你的支持。歡迎參加 Cerus Corporation 2024 年第三季財報電話會議。（操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to Jessica Hanover. Dr. Hanover, you may begin.

我現在想把會議交給傑西卡·漢諾威。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. 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. 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.

謝謝你，下午好。我要感謝大家今天加入我們。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。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； Kevin Green，Cerus 財務長；以及 Cerus 資深副總裁 Carol Moore。

Cerus issued a press release today announcing our financial results for the third quarter ended September 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. 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. 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, our product supply expectations and ability to meet customer demand, the potential value of and anticipated activities to be funded under our new BARDA agreement, planned regulatory submissions and 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.

Cerus 今天發布新聞稿，公佈了截至 2024 年 9 月 30 日的第三季財務業績，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。我想提醒您，我們將在本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、我們對經營現金流的預期、非GAAP 調整後EBITDA 業績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、我們的產品供應期望和滿足客戶需求的能力、根據我們新的BARDA 協議資助的潛在價值和預期活動、計劃的監管提交和產品發布、產品擴展前景以及其他非歷史事實的陳述。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。

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 September 30, 2024, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. 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.

它們在今天的新聞稿、我們的幻燈片演示以及截至 2024 年 9 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，我們將很快提交該季度。我們不承擔更新前瞻性陳述的責任或義務。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。有關非公認會計原則財務指標與最具可比性的公認會計原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演示。

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. 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，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。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. I would like to open the call with a review of our strong quarterly performance on both commercial and financial fronts, as well as our increasingly positive outlook for the full year 2024. Our North American platelet business drove our Q3 product revenue result, and our INTERCEPT Fibrinogen Complex or IFC business in the US is gaining momentum at the same time that we are increasing supply capacity for the product. Vivek will provide additional color in his remarks.

謝謝你，潔西卡，大家下午好。我想在電話會議開始時回顧我們在商業和財務方面強勁的季度業績，以及我們對 2024 年全年日益樂觀的前景。我們的北美血小板業務推動了我們第三季產品收入的成長，而我們在美國的 INTERCEPT 纖維蛋白原複合物或 IFC 業務在我們增加產品供應能力的同時也在獲得動力。維韋克將在他的演講中提供更多的色彩。

With this trajectory, we are raising our product revenue guidance to account for the positive trends in both these business segments. We are also executing on the financial measures that we have been targeting for the full year, both on the bottom line as well as operating cash flows, as you will hear from Kevin shortly. With the growing scale of our business, the leverage of our business model and the discipline around our operating expenses, we've been able to consistently deliver against our quarterly financial targets. At a high level, and on the heels of the Annual Meeting of the Association for the Advancement of Blood and Biotherapies, or AABB, earlier this month, it is gratifying to see how pathogen inactivation has become increasingly ubiquitous across the transfusion services in the US and in multiple geographies from blood centers that manufacture pathogen inactivated components to the hospital clinicians who transfuse them.

按照這一軌跡，我們正在提高產品收入指導，以應對這兩個業務領域的積極趨勢。我們也正在執行全年目標的財務措施，包括利潤和營運現金流，您很快就會聽到凱文的消息。隨著我們業務規模的不斷擴大、業務模式的槓桿作用以及營運費用的嚴格控制，我們能夠始終如一地實現季度財務目標。在本月稍早舉行的血液和生物治療促進協會 (AABB) 年會之後，令人欣慰的是，病原體滅活在美國輸血服務中變得越來越普遍在多個地區，從生產病原體滅活成分的血液中心到輸血的醫院臨床醫師。

And sitting in the plenary session at the Houston Convention Center with thousands of AABB meeting participants listening to the presentation of the positive ReCePI Phase III clinical trial data was truly a rewarding experience. The further acknowledgment from the recent up to $248 million BARDA contract designed to see the INTERCEPT RBC program through potential regulatory approval and product launch only added to the collective enthusiasm from our blood center customers for the ReCePI data. Meanwhile, the need for pathogen inactivation is ongoing. Since our last quarterly call when we noted the rise in dengue transmission in the US and Europe, multiple US.

坐在休士頓會議中心的全體會議上，與數千名 AABB 與會者一起聆聽 ReCePI III 期臨床試驗積極數據的介紹，這確實是一次有益的經歷。最近高達 2.48 億美元的 BARDA 合約的進一步確認，旨在讓 INTERCEPT RBC 計劃獲得潛在的監管批准和產品發布，這進一步增加了我們血液中心客戶對 ReCePI 數據的集體熱情。同時，滅活病原體的需求仍在持續。自從我們上一次季度電話會議以來，我們注意到美國和歐洲（多個美國）的登革熱傳播有所增加。

public health officials have released notifications regarding the rise in the incidence of two emerging arthropod-borne viruses, Eastern equine encephalitis virus or EEEV, and oropouche virus or OROV. Together, EEEV and travel-related OROV cases have been reported in 12 states and US territories to date. CDC and FDA recommend donor deferrals for those recently diagnosed with these viruses, reminding our community that the potential exists for the disruption of our local blood supplies. And while there remains no evidence of transfusion transmission to date, the similarities of OROV to the Zika virus epidemic and the new evidence of vertical transmission argue that precaution and preparedness are warranted.

公共衛生官員發布了關於兩種新興節肢動物傳播病毒——東部馬腦炎病毒（EEEV）和奧羅普切病毒（OROV）發病率上升的通知。迄今為止，已有 12 個州和美國領地報告了 EEEV 和與旅行相關的 OROV 病例。疾病管制與預防中心 (CDC) 和食品藥物管理局 (FDA) 建議推遲最近診斷出感染這些病毒的人的捐贈者的捐獻，提醒我們的社區，我們當地的血液供應可能會受到干擾。儘管迄今為止尚無輸血傳播的證據，但 OROV 與寨卡病毒流行的相似性以及垂直傳播的新證據表明，預防和準備是必要的。

On the development front, as we announced earlier this month, in Europe, we are closely collaborating with our notified body, TUV SUD, to define our strategy for a potential new and enhanced CE Mark submission for INTERCEPT red blood cells or RBCs. As we noted before, while we are disappointed that our INTERCEPT RBC filing was not approved by our competent authority, we are closely assessing the potential to include data from both ReCePI and RedeS clinical trials in a future filing with the intent to seek a broader patient indication for the product candidate. In the US, we are moving full speed ahead after extending our partnership with BARDA, which is designed to fund further development, regulatory activities and ultimately anticipated commercial readiness initiatives for INTERCEPT RBCs. We have also recently completed our regulatory submission to TUV for our LED illuminator in Europe, marking the next step in our effort to make this next-generation technology platform available to our customers in that geography. Based upon extensive feedback from our customers, we believe that this new platform is eagerly awaited and will provide multiple benefits for the production of INTERCEPT treated platelets and plasma in routine.

在開發方面，正如我們本月早些時候在歐洲宣布的那樣，我們正在與我們的認證機構 TUV SUD 密切合作，制定我們針對 INTERCEPT 紅血球或紅血球提交潛在的新的增強型 CE 標誌的策略。正如我們之前指出的，雖然我們對我們的 INTERCEPT RBC 備案未得到主管部門批准感到失望，但我們正在仔細評估在未來的備案中納入 ReCePI 和 RedeS 臨床試驗數據的可能性，以尋求更廣泛的患者候選產品的指示。在美國，我們在擴大與 BARDA 的合作關係後正在全速前進，該合作旨在為 INTERCEPT RBC 的進一步開發、監管活動和最終預期的商業準備計劃提供資金。我們最近也完成了針對歐洲 LED 照明器向 TUV 的監管提交，這標誌著我們在向該地區的客戶提供這項下一代技術平台方面又邁出了下一步。根據客戶的廣泛回饋，我們相信這個新平台備受期待，並將為常規生產 INTERCEPT 處理的血小板和血漿提供多種好處。

With that, I will now turn the call over to Vivek to discuss our commercial results and progress for the third quarter of 2024 as well as our outlook for the last three months of the year.

現在，我將把電話轉給 Vivek，討論我們 2024 年第三季的商業業績和進展，以及我們對今年最後三個月的展望。

Thank you, Obi, and good afternoon, everyone. Entering 2024, we committed to a return to growth across our commercial organization. As we exited the first half of 2024, we were back on a growth trajectory, and I am pleased to report that we continued that trend in the recently completed third quarter. As with prior periods in 2024, the strength of our US platelet franchise led the way, and we continue to see encouraging growth in our US.

謝謝你，奧比，大家下午好。進入 2024 年，我們致力於整個商業組織恢復成長。隨著 2024 年上半年的結束，我們又回到了成長軌道，我很高興地報告說，我們在最近完成的第三季度繼續了這一趨勢。與 2024 年之前的時期一樣，我們美國血小板特許經營權的實力處於領先地位，我們繼續看到我們在美國的令人鼓舞的增長。

IFC business. With respect to US platelets, we estimate that nearly 2/3 of all platelets distributed to US hospitals are pathogen reduced. We continue to make good headway with customers, both blood centers and hospitals, who are ramping their adoption of INTERCEPT platelets while holding strong with customers who are already at 100% INTERCEPT platelet adoption.

國際金融公司業務。就美國血小板而言，我們估計分配給美國醫院的所有血小板中有近 2/3 是病原體減少的。我們繼續與血液中心和醫院等客戶取得良好進展，他們正在加大對 INTERCEPT 血小板的採用，同時保持對已經 100% 採用 INTERCEPT 血小板的客戶的支持。

We believe the marketplace views INTERCEPT-treated platelets as the safest option for patients and this was supported by plenary presentations, posters and symposia activities at the annual AABB meeting earlier this month. The peer-to-peer interaction and support of INTERCEPT adoption was incredibly encouraging to witness. Our team simply had to facilitate introductions and the number of high-volume INTERCEPT platelet users in attendance was significant. This dynamic also played out with international markets, where we saw a good number of Canadian, Middle Eastern and European customers at the meeting, and they too were eager to share their positive experiences with INTERCEPT. Last quarter, we saw continued adoption of IFC within the US.

我們相信市場將 INTERCEPT 治療的血小板視為患者最安全的選擇，而這一點得到了本月早些時候 AABB 年度會議上的全體演講、海報和研討會活動的支持。同行間的互動和對 INTERCEPT 採用的支持令人難以置信地令人鼓舞。我們的團隊只需促進介紹，出席的大量 INTERCEPT 血小板用戶數量非常可觀。這種動態也體現在國際市場上，我們在會議中看到了大量加拿大、中東和歐洲客戶，他們也渴望分享他們對 INTERCEPT 的正面體驗。上季度，我們看到美國繼續採用 IFC。

As we have discussed in past quarterly calls, we are closely monitoring demand increases and working hand in glove with our blood center production partners to ensure they can deliver sufficient supply. We were pleased to see the issuance of three new BLA approvals in the third quarter. This will enable broader interstate shipment of IFC and enable us to meet demand at many hospitals do not currently have an IFC-producing blood center in their state. As with PR platelets, the recent AABB meeting was great to drive further education and awareness of IFC. Of note, we hosted a standing-room-only workshop where the Head of Laboratory Services at Barnes-Jewish Hospital in St.

正如我們在過去的季度電話會議中討論的那樣，我們正在密切監控需求的成長，並與我們的血液中心生產合作夥伴密切合作，以確保他們能夠提供充足的供應。我們很高興看到第三季發布了三項新的 BLA 批准。這將使 IFC 能夠實現更廣泛的州際運輸，並使我們能夠滿足許多州內目前沒有 IFC 生產血液中心的醫院的需求。與 PR 血小板一樣，最近的 AABB 會議非常有助於推動國際金融公司的進一步教育和認識。值得注意的是，我們舉辦了一場僅限站立的研討會，聖路易斯巴恩斯猶太醫院實驗室服務負責人參加了研討會。

Louis, Missouri described how they chose to adopt IFC 100% and the pathway they took to get there. Most encouragingly, she laid out the operational and financial benefits above and beyond the clinical utility that they've experienced in deciding to go all in on IFC. We are encouraged by the demand for IFC and we continue to see an increase in inbound inquiries about the product. Looking outside of the US, we experienced expected seasonality in our EMEA franchise and things slowed down over the summer holiday period, most notably in July and August. Nonetheless, we continue to see encouraging progress in our key growth geographies and are excited about the prospects for INTERCEPT adoption in key strategic markets.

密蘇裡州聖路易斯描述了他們如何選擇 100% 採用 IFC 以及他們實現這一目標的途徑。最令人鼓舞的是，她列出了他們在決定全力投入 IFC 時所經歷的臨床效用之外的營運和財務收益。我們對 IFC 的需求感到鼓舞，我們繼續看到有關該產品的入站詢問有所增加。看看美國以外的地區，我們的歐洲、中東和非洲特許經營權經歷了預期的季節性，並且在暑假期間，尤其是七月和八月，情況放緩。儘管如此，我們繼續看到我們的主要成長地區取得了令人鼓舞的進展，並對關鍵策略市場採用 INTERCEPT 的前景感到興奮。

We will keep you posted as we make progress on key international market development initiatives. Lastly, I want to thank and acknowledge our global supply chain and logistics teams who continue to navigate challenging situations while ensuring that customer impact is mitigated. Despite the recent dockworkers strike along the US Eastern Seaboard, we were able to meet all customer requests within Q3. As we discussed earlier this year, the supply chain team did fantastic work helping to navigate any concerns with short-dated products and ensure that customers were not only getting product, but also able to distribute to their hospital customers in a timely manner.

當我們在關鍵的國際市場開發計劃上取得進展時，我們將及時通知您。最後，我要感謝並認可我們的全球供應鏈和物流團隊，他們繼續應對充滿挑戰的情況，同時確保減輕對客戶的影響。儘管最近美國東海岸發生了碼頭工人罷工，但我們仍能夠在第三季滿足所有客戶的要求。正如我們今年稍早討論的那樣，供應鏈團隊做了出色的工作，幫助解決了對短期產品的任何擔憂，並確保客戶不僅能夠獲得產品，而且能夠及時分發給醫院客戶。

The logistics teams are always behind the curtain and rarely recognized, so I want to be explicit in my gratitude for all the work they do to support the global sales team and most importantly, our blood center and hospital customers. As evidenced by raising our product revenue guidance for the full year, we are confident that our business is once again on a growth trajectory. What's most exciting is to see both existing and new customers realize the clinical benefits of [pass-through injection] and become advocates for the technology. I look forward to updating you on our continued progress, and I thank you for your support of and interest in our efforts. I'd like to hand the call over to Kevin to update you on our financial results.

物流團隊總是在幕後，很少被認可，所以我想明確感謝他們為支持全球銷售團隊，最重要的是我們的血液中心和醫院客戶所做的所有工作。正如我們提高全年產品收入指引所證明的那樣，我們對我們的業務再次走上成長軌道充滿信心。最令人興奮的是看到現有客戶和新客戶都認識到[直通注射]的臨床益處並成為該技術的倡導者。我期待著向您通報我們不斷取得的進展，並感謝您對我們努力的支持和興趣。我想將電話轉接給凱文，向您通報我們的最新財務表現。

Thanks, Vivek. Good afternoon and thank you all for joining us. On today's call, I'll be discussing our financial results for the third quarter of 2024. As we near the end of the year, I'll also provide some color related to our strong progress on the financial goals we set out at the beginning of the year. To start, we posted product revenue of $46 million for the third quarter of 2024.

謝謝，維韋克。下午好，感謝大家加入我們。在今天的電話會議上，我將討論 2024 年第三季的財務表現。隨著年底的臨近，我還將提供一些與我們在年初制定的財務目標方面取得的強勁進展相關的資訊。首先，我們公佈 2024 年第三季的產品收入為 4,600 萬美元。

This represents year-over-year growth of 16% and brings product revenue for the first nine months of the year to $129.5 million, up 18% from the prior-year period. North American platelet sales continued to be the major contributor to our product revenue growth during the quarter. In the US, third quarter 2024 product revenues exceeded prior-year levels by 17%. With Canadian Blood Services now at 100% entering the third quarter, sales in this geography were an important contributor to our year-over-year growth as well. In EMEA, third quarter product revenues were relatively stable to slightly higher compared to the prior-year period and to the second quarter of 2024.

這意味著年增 16%，今年前 9 個月的產品收入達到 1.295 億美元，比去年同期成長 18%。北美血小板銷售仍然是本季我們產品收入成長的主要貢獻者。在美國，2024 年第三季產品營收比上年同期成長 17%。隨著加拿大血液服務公司 (Canadian Blood Services) 進入第三季度，該地區的銷售額現已達到 100%，該地區的銷售額也是我們同比增長的重要貢獻者。在歐洲、中東和非洲地區，第三季產品收入與去年同期和 2024 年第二季相比相對穩定或略有上升。

FX rates provided a slight tailwind for the EMEA business of around 1% over the prior-year period. On a consolidated basis, FX rates were less impactful, benefiting the top line results by approximately 40 basis points. Also, for Q3, we posted IFC product revenue of $2.3 million, up from $1.7 million in the prior-year period, driven by more standing orders and depth within existing accounts. In addition to our product revenue and not included in our guidance, government contract revenue totaled $4.6 million in Q3 compared to $7.5 million for the prior-year period. The completion of our US

匯率為 EMEA 業務提供了比去年同期約 1% 的小幅推動。綜合來看，匯率影響較小，使營收成長約 40 個基點。此外，在第三季度，我們公佈的 IFC 產品收入為 230 萬美元，高於去年同期的 170 萬美元，這主要是由於長期訂單增加和現有帳戶深度的推動。除了我們的產品收入（未包含在我們的指導中）之外，第三季的政府合約收入總計 460 萬美元，而去年同期為 750 萬美元。完成我們的美國

Phase III ReCePI clinical trial was the primary driver for the decline. As we look ahead, we expect government contract revenue will increase from Q3 levels due to a variety of factors, including enrollment ramping up at site participating in our RedeS clinical study, activities supporting our new BARDA contract, which will overlap with the prior contract and the ongoing development work with other government agencies. As a reminder, included in our government contract revenue are the revenues recognized as reimbursement under our contracts with BARDA, our agreement with the FDA to further whole blood pathogen reduction, and our milestone-based agreement with the US Department of Defense for lyophilized IFC. Turning now to our product gross profit and gross margins.

III 期 ReCePI 臨床試驗是下降的主要驅動因素。展望未來，我們預計政府合約收入將比第三季度的水平有所增加，原因有多種，包括參與我們的RedeS 臨床研究的現場註冊人數增加、支持我們新的BARDA 合約的活動（該合約將與之前的合約重疊）以及與其他政府機構正在進行的開發工作。提醒一下，我們的政府合約收入包括根據我們與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。現在談談我們的產品毛利和毛利率。

Our third quarter product gross profit was $26.2 million compared to $21.8 million during the prior-year period, an increase of 20% year-over-year. Product gross margins for the third quarter were 56.9%, up 200 basis points from the 54.9% reported in Q3 of last year and the 54.7% from Q2 of this year. The improvement in gross margins was primarily driven by lower product costs and lower supply chain costs for warehousing and freight. Absent any unanticipated factor, we continue to expect that gross margins will remain relatively close to Q3 levels for the balance of the year. Moving on, our third quarter operating expenses, which totaled $31.8 million, were down 8% from the $34.5 million of Q3 of 2023.

我們第三季的產品毛利為 2,620 萬美元，而去年同期為 2,180 萬美元，較去年同期成長 20%。第三季產品毛利率為56.9%，較去年第三季的54.9%和今年第二季的54.7%上升200個基點。毛利率的改善主要是由於產品成本降低以及倉儲和貨運供應鏈成本降低。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相對接近第三季的水平。接下來，我們第三季的營運支出總計 3,180 萬美元，比 2023 年第三季的 3,450 萬美元下降了 8%。

Included in the operating expenses for Q3 of last year were $1.6 million of restructuring charges, which were not incurred in the current year quarter. Q3 2024 operating expenses included $5.8 million in non-cash stock-based compensation. By specific expense type, third quarter R&D expenses totaled $14 million compared to $16.8 million during the prior-year period. Similar to our Q1 and Q2 results, this 17% decline was driven primarily by the completion of the ReCePI clinical trial and the effects of the restructuring implemented midyear last year. While we don't expect significant movement in our R&D expenses for the fourth quarter, we would expect to see a modest increase as RedeS sites ramp enrollment and as we begin activities covered under our new BARDA contract.

去年第三季的營運費用包括 160 萬美元的重組費用，該費用在本季沒有發生。2024 年第三季營運費用包括 580 萬美元的非現金股票薪酬。以具體費用類型劃分，第三季研發費用總計 1,400 萬美元，去年同期為 1,680 萬美元。與我們第一季和第二季的結果類似，這 17% 的下降主要是由於 ReCePI 臨床試驗的完成以及去年年中實施的重組的影響。雖然我們預計第四季度的研發費用不會出現重大變化，但隨著 RedeS 網站註冊人數的增加以及我們開始新的 BARDA 合約涵蓋的活動，我們預計會出現小幅增長。

Third quarter SG&A expenses were $17.8 million compared to $16.2 million during the prior-year period. We continue to generate increasing levels of leverage from our SG&A expenses. We expect that to continue and do not anticipate significant swings in SG&A for the remainder of 2024. Let's now focus on the bottom line in non-GAAP adjusted EBITDA results. On the bottom line, reported net loss attributable to Cerus for the three months ended September 30, 2024, improved significantly when compared to the same period in the prior year.

第三季銷售、管理及行政費用為 1,780 萬美元，而上年同期為 1,620 萬美元。我們繼續從銷售、管理及行政費用中產生越來越高的槓桿水平。我們預計這種情況將持續下去，並且預計 2024 年剩餘時間內銷售管理及行政費用不會有重大波動。現在讓我們專注於非 GAAP 調整後 EBITDA 業績的底線。總而言之，截至 2024 年 9 月 30 日的三個月，Cerus 報告的淨虧損與去年同期相比顯著改善。

Net loss attributable to Cerus for Q3 narrowed by 60% to $2.9 million or $0.02 per diluted share compared to $7.3 million or $0.04 per diluted share for the prior-year period. As a measure of the operating leverage we're generating, the net loss for Q3 was less than our non-cash stock-based compensation mentioned previously, suggesting that the business is making significant strides operationally. On a non-GAAP adjusted EBITDA basis, Q3 of 2024 generated a positive adjusted EBITDA of $4.4 million compared to a loss of nearly $1 million for the prior-year period. For the nine months ended September 30, we have now turned the corner and have posted positive adjusted EBITDA of $2.5 million year-to-date. We're pleased with the adjusted EBITDA result and are increasingly confident in our ability to deliver a positive adjusted EBITDA for 2024 as a whole.

第三季 Cerus 的淨虧損收窄 60%，至 290 萬美元，即稀釋後每股 0.02 美元，而去年同期為 730 萬美元，即稀釋後每股 0.04 美元。作為衡量我們產生的營運槓桿的指標，第三季的淨虧損低於我們先前提到的非現金股票薪酬，這表明該業務在營運方面正在取得重大進展。在非 GAAP 調整後 EBITDA 基礎上，2024 年第三季調整後 EBITDA 為 440 萬美元，而去年同期虧損近 100 萬美元。截至 9 月 30 日的九個月，我們現已渡過難關，年初至今調整後 EBITDA 為 250 萬美元。我們對調整後的 EBITDA 結果感到滿意，並對我們在 2024 年整體實現積極的調整後 EBITDA 的能力越來越有信心。

As we look ahead, we expect more of the same with the expected growth contemplated in our revised guidance, a continued focus on generating leverage from our operating expenses and stable gross margins, which are all expected to contribute to the anticipated achievement of our 2024 adjusted EBITDA goal. On the balance sheet and associated cash flows, we ended the third quarter with a cash position of $75.6 million of cash, cash equivalents and short-term investments on the balance sheet. Operationally, we continue to deliver positive operating cash flows. For the third quarter, we generated positive operating cash flows of $4.1 million compared to cash used for the operations of $10.5 million during the third quarter of 2023. Cash flow from operations for the nine months ended September 30, 2024 totaled $6.4 million compared to cash used from operations of $28 million in the prior-year period.

展望未來，我們預計修訂後的指引中預期的成長將更加一致，繼續關注從我們的營運支出和穩定的毛利率中產生槓桿作用，這些都預計將有助於我們 2024 年調整後的預期成就EBITDA目標。在資產負債表和相關現金流方面，截至第三季末，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 7,560 萬美元。在營運方面，我們持續提供正的營運現金流。第三季度，我們產生了 410 萬美元的正營運現金流，而 2023 年第三季營運所用現金為 1,050 萬美元。截至 2024 年 9 月 30 日的九個月營運現金流總計 640 萬美元，而去年同期營運現金流為 2,800 萬美元。

We will continue to focus on our cash flows as we work to improve the health of our balance sheet. Turning now to our guidance. As you've heard from both Obi and Vivek, we are increasingly confident in our top line at this point in the year. And so we are raising our full year 2024 product revenue guidance to the range of $177 million to $179 million, up from our prior range of $175 million to $178 million. In tandem, we are raising the bottom end of our full year 2024 IFC revenue guidance to a new range of $9 million to $10 million from $8 million to $10 million.

我們將繼續關注現金流，並努力改善資產負債表的健康狀況。現在轉向我們的指導。正如您從 Obi 和 Vivek 那裡聽到的那樣，我們對今年這個時候的營收越來越有信心。因此，我們將 2024 年全年產品收入指引從先前的 1.75 億美元到 1.78 億美元提高到 1.77 億美元到 1.79 億美元。同時，我們將 2024 年全年 IFC 收入指引的下限從 800 萬美元至 1,000 萬美元上調至 900 萬美元至 1,000 萬美元的新區間。

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

至此，我現在想將電話轉回給奧比，讓他做一些結束語。

Thank you, Kevin. We are very pleased to be continuing to execute on the ambitious goals we set out at the beginning of the year. With two months left in 2024, we feel confident about where we stand relative to these goals and are looking forward to sharing our expectations for 2025 with you in just a couple of months. Most importantly, we know that our growth as a company is a direct reflection of the confidence that our customers have in Cerus and the INTERCEPT technology, enabling patients across the globe to have access to safe blood when they need it most and creating a new standard of care in transfusion medicine. It is an honor to partner with our customers as well as organizations like US.

謝謝你，凱文。我們很高興能夠繼續執行我們年初制定的宏偉目標。距離 2024 年還有兩個月，我們對實現這些目標的進展充滿信心，並期待在短短幾個月內與您分享我們對 2025 年的期望。最重要的是，我們知道我們作為一家公司的成長直接反映了我們的客戶對 Cerus 和 INTERCEPT 技術的信心，使全球各地的患者在最需要的時候能夠獲得安全的血液，並創造了新的標準輸血醫學護理。很榮幸與我們的客戶以及像美國這樣的組織合作。

BARDA as we continue to focus on meeting this need. Thank you for your continued interest in Cerus. I will now turn the call over to the operator for questions.

BARDA 我們將繼續專注於滿足這項需求。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) Our first question comes from Ross Osborn with Cantor Fitzgerald.

（操作員說明）我們的第一個問題來自羅斯·奧斯本和坎托·菲茨杰拉德。

This is Matthew Park on for Ross. I just want to start off talking about the IFC business here. Now that you've added on an additional three BLA approvals, do you anticipate needing additional manufacturing capacity to meet this growing demand? Or do you feel comfortable at current levels?

我是羅斯的馬修·帕克。我只想先談談國際金融公司的業務。既然您已經獲得了額外的三個 BLA 批准，您是否預計需要額外的製造能力來滿足這一不斷增長的需求？或者你對目前的水平感到滿意嗎？

Thanks, Matthew. Vivek, do you want to handle this?

謝謝，馬修。維韋克，你想處理這件事嗎？

Sure. I'd be happy to. Thanks for the question. We continue to work with blood centers to add manufacturers for IFC. And as demand grows, we anticipate we'll continue to grow supply as well.

當然。我很樂意。謝謝你的提問。我們繼續與血液中心合作，為 IFC 添加製造商。隨著需求的成長，我們預計供應也將繼續增加。

The addition of the three BLAs in the quarter is certainly significant to ensure that we can continue to meet the demand that we're seeing growing. But we anticipate that demand will continue to grow and as such, we'll continue to recruit and partner with more blood centers to produce IFC.

本季增加三個 BLA 對於確保我們能夠繼續滿足不斷增長的需求無疑具有重要意義。但我們預計需求將繼續增長，因此，我們將繼續招募更多血液中心並與更多血液中心合作生產 IFC。

Great. That makes sense. And then I guess just one more for me. With the LED illuminator, have you guys noticed -- or obviously, you've gotten positive feedback from AABB. What does the timeline look like for receiving an approval decision here?

偉大的。這是有道理的。然後我想我還需要再做一件事。對於 LED 照明器，你們注意到了嗎？這裡收到批准決定的時間表是怎樣的？

And is there a replacement timeline with the legacy device?

舊設備是否有更換時間表？

Yes. Thanks, Matthew. So right now, we're targeting a launch for the LED illuminator in Europe in 2025. And we really see this as sort of a foundational new platform for our business and for the use of platelets and plasma in blood centers. Right now, the assumption is that we'll be rolling this out across multiple customers throughout 2025 and '26 in Europe.

是的。謝謝，馬修。因此，我們目前的目標是 2025 年在歐洲推出 LED 照明器。我們確實將其視為我們業務以及血液中心血小板和血漿使用的基礎新平台。目前，我們的假設是我們將在 2025 年和 26 年在歐洲向多個客戶推出此功能。

And then we're still in the process of putting together a PMA submission in the United States for the LED illuminator that's likely to take place more in the 2026 time frame. So overall, we're really excited about getting this product to market. It's been a partnership with a lot of our blood center customers in the development of this program. And it really also is an important element of our innovating on the technology going forward, allowing us to improve the process in the future.

然後，我們仍在美國整理 LED 照明器的 PMA 提交文件，這可能會在 2026 年的時間範圍內進行。總的來說，我們非常高興將該產品推向市場。在該計劃的開發過程中，我們與許多血液中心客戶建立了合作夥伴關係。這確實也是我們未來技術創新的重要因素，使我們能夠在未來改進流程。

Got it. That's it for me. Congrats again on the quarter. Thanks.

知道了。對我來說就是這樣。再次恭喜本季。謝謝。

(Operator Instructions) Mat Blackman, Stifel.

（操作員說明）Mat Blackman，Stifel。

This is Colin on for Mat. I wanted to start with a couple on IFC and what's driving the recent momentum and guidance range. Is this growth primarily from new customers or going deeper into your existing accounts or both? How should we think about the number of accounts you guys are in today versus the potential opportunity for what's out there?

這是科林為馬特代言的。我想先談談國際金融公司的一些情況，以及推動近期動能和指導範圍的因素。這種成長主要來自新客戶還是深入現有客戶或兩者兼具？我們應該如何考慮你們今天擁有的帳戶數量與現有帳戶的潛在機會？

Yes. Thanks, Colin, for the question. Vivek, would you mind taking this one as well?

是的。謝謝科林的提問。維韋克，你介意也拿走這個嗎？

Sure. I'd be happy to. So, to answer the question, growth is coming both from depth within existing customers as well as new customer acquisition. We estimate that roughly 55%, 60% of customers were added this calendar year. So those are new customers.

當然。我很樂意。因此，要回答這個問題，成長既來自現有客戶的深度，也來自新客戶的獲取。我們估計今年大約增加了 55%、60% 的客戶。這些都是新客戶。

But then those that started last year, many of them started in one clinical area of the hospital. And as they generated evidence of the value of IFC that sort of moved out to other clinical departments. And then there are certain institutions, I referenced Barnes-Jewish and St. Louis earlier that are now 100% IFC across all of their clinical departments. So we're seeing good growth in both areas.

但去年開始的那些，其中許多都是從醫院的一個臨床區域開始的。當他們產生了 IFC 價值的證據時，這些證據就轉移到了其他臨床部門。還有一些機構，我之前提到過 Barnes-Jewish 和 St. Louis，現在它們的所有臨床部門都是 100% IFC。因此，我們在這兩個領域都看到了良好的成長。

And for our sales organization and our production partners, really, the focus is on getting existing customers to 100% and then continuing to fill that funnel with new hospital targets and new hospitals that are getting onboarded as each month passes. So it's great to see because we think that provides us with significant runway for this therapeutic category.

對於我們的銷售組織和生產合作夥伴來說，實際上，重點是讓現有客戶達到 100%，然後繼續用新的醫院目標和每個月加入的新醫院來填充該管道。所以很高興看到這一點，因為我們認為這為我們這個治療類別提供了重要的跑道。

That's really helpful. And it does look like IFC is going to exit the year at around a $3 million to $4 million quarterly run rate. So how should we be thinking about IFC in 2025? What are the key growth drivers for next year in particular? And is something in the [$15 million] range, a reasonable starting point for the full year number?

這真的很有幫助。看起來 IFC 確實將以 300 萬至 400 萬美元的季度運行速度結束今年。那麼，2025 年我們該如何看待 IFC？明年的主要成長動力是什麼？[1500 萬美元]範圍內的東西是全年數字的合理起點嗎？

Yes. Thanks, Colin. Obviously, we're not going to be providing guidance today on the call for IFC revenue in 2025. But I think Vivek can give you a little bit more color on sort of why we believe there's momentum growing just based upon the demand we're seeing and our now increasing ability to supply that demand.

是的。謝謝，科林。顯然，我們今天不會就 IFC 2025 年收入的呼籲提供指導。但我認為 Vivek 可以為您提供更多信息，說明為什麼我們相信，基於我們所看到的需求以及我們現在滿足該需求的能力不斷增強，勢頭會不斷增長。

Yes. Thanks, Obi. I think the drivers remain largely the same. We referenced the fact that three BLAs were issued for production partners in the last quarter. There's a little bit of ramp-up time once they get the BLA to increase their manufacturing base and start to distribute product.

是的。謝謝，奧比。我認為驅動因素基本上保持不變。我們提到了上個季度為生產合作夥伴發布了三份 BLA 的事實。一旦他們獲得 BLA 來擴大製造基地並開始分銷產品，就會有一點啟動時間。

But all of that will drive growth. That also gives both the blood centers and our team greater conviction around opening up new accounts so they know supply will be there. So that will continue to drive the therapy adoption and top line growth into 2025. And then what we're seeing as well, if you think about what hospitals went through with COVID in terms of budget crisis and really having tremendous issues staffing, maintaining staff at hospitals, they were really loath to take on new projects. Certain hospitals recovered at a faster rate.

但所有這些都將推動成長。這也讓血液中心和我們的團隊更有信心開設新帳戶，這樣他們就知道會有供應。因此，到 2025 年，這將繼續推動療法的採用和營收成長。然後我們也看到了，如果你想想醫院在預算危機方面經歷了新冠疫情，並且在人員配備、維持醫院員工方面確實遇到了巨大的問題，他們真的不願意承擔新項目。某些醫院的恢復速度較快。

What we're seeing now is as more hospitals feel like they're in a stronger financial position and they're fully staffed, they are amenable to starting --taking on new projects like IFC. And that dovetails with what they're hearing at conferences like the recently attended AABB where they're seeing podium presentations about the technology. So all of these things are dovetailing together to create what we believe are meaningful tailwinds supporting our business.

我們現在看到的是，越來越多的醫院感覺自己的財務狀況更強勁，人員配備齊全，願意開始承擔國際金融公司等新專案。這與他們在最近參加的 AABB 等會議上聽到的內容相吻合，他們在會議上看到了有關該技術的講台演示。因此，所有這些事情相互結合，創造出我們認為對我們的業務有意義的推動力。

I appreciate the additional color. I'll hop back in the queue.

我很欣賞額外的顏色。我會跳回到隊列中。

(Operator Instructions) Jacob Johnson, Stephens.

（操作員說明）Jacob Johnson，Stephens。

And I'll echo my congrats on the quarter and preemptive apologies for the -- another 2025 question after Obi you've mentioned that you'll address that in a couple of months and maybe a bit nitpicky. But if I look at kind of the midpoint of the guidance, what it implies for 4Q, it implies kind of a mid-single-digit growth rate in the fourth quarter. Again, understanding it's too early to guide to 2025, but could you maybe just frame up why or why not that's the best jumping off point for next year and IFC may be the answer. But just any thoughts there?

我將重申我對本季的祝賀，並對奧比之後的另一個 2025 年問題表示先發製人的歉意，你提到你將在幾個月內解決這個問題，也許有點挑剔。但如果我看一下指導的中點，它對第四季度意味著什麼，它意味著第四季的成長率為中個位數。再次強調，現在指導 2025 年還為時過早，但您能否闡述為什麼或為什麼不這是明年的最佳起點，而 IFC 可能是答案。但只是有什麼想法嗎？

Yes. I mean I think as we were looking at the guidance for this quarter, two months left in the year, we just really wanted to provide our best sort of projection for what the growth looked like for the remaining two months. But I think Vivek can sort of give you sort of a perspective on sort of why we did that and sort of the optimism going into 2025.

是的。我的意思是，我認為，當我們查看本季度的指導時，今年還剩下兩個月，我們真的想為剩下兩個月的成長提供最好的預測。但我認為 Vivek 可以讓您了解我們這樣做的原因以及對 2025 年的樂觀態度。

Yes, I think you captured most of it. I mean, at this point, with October nearly done and two months remaining, we have good insight into what orders are out there, what new accounts will open. Things will slow down a little bit as we head into the holidays. So some of those de novo account openings may move to early 2025. But fundamentally, if you look at inventory levels with our key customers, as well as the feedback we're getting from hospitals about their initial experiences with IFC, all of these things right now are trending positive, which is what gives us confidence about how we'll close the year and the fact that we'll have a bit of a tailwind entering into '25.

是的，我想你捕捉到了大部分內容。我的意思是，此時，十月即將結束，還剩下兩個月，我們對現有訂單、將開設哪些新帳戶有了很好的了解。當我們進入假期時，事情會放緩一些。因此，其中一些重新開設帳戶可能會推遲到 2025 年初。但從根本上說，如果你看看我們主要客戶的庫存水平，以及我們從醫院得到的關於他們與國際金融公司的初步經驗的反饋，所有這些現在都呈積極趨勢，這讓我們對如何我們將結束這一年，事實上，進入25 年我們將有一些順風順水。

Not to be too demure, but as mentioned earlier, I think we'll reserve a more detailed discussion about '25 outlook until early next year. But what's encouraging to me is we had committed to returning to growth this year after a challenging 2023. We sort of put the foundational pieces in place with our Q1 and Q2 performance and then we were able to add another solid quarter here in the third quarter and we're sort of heads down sprinting to do it again in Q4.

不要太拘謹，但正如前面提到的，我認為我們將在明年初之前對 '25 前景進行更詳細的討論。但令我鼓舞的是，在經歷了充滿挑戰的 2023 年後，我們致力於今年恢復成長。我們在第一季和第二季的表現中奠定了基礎，然後我們能夠在第三季再增加一個穩定的季度，我們正在埋頭衝刺，在第四季度再次做到這一點。

Got it. And then, Obi, just on this next-gen illuminator, you mentioned some good feedback from customers and their interest in it. Can you just talk about the value proposition of this next-gen illuminator for your customer base as we think about adoption upon potential approval?

知道了。然後，Obi，就這款下一代照明器而言，您提到了客戶的一些良好回饋以及他們對此的興趣。當我們考慮在潛在批准後採用時，您能否談談這款下一代照明器對您的客戶群的價值主張？

I think fundamentally for our customers, what they really depend on is our supply chain continuity and also the performance of our system. Because as you might imagine, since they've adopted our technology at 100% in many markets, if for whatever reason, our supply chain wasn't solid and that means both on the kit side, but also on the operational side with the device, that it would shut down their blood supply. Historically, we've had a very reliable system with the current INT100 Illuminator and then moving into a new platform, if you will, with this LED-based illuminator. We had to have something that was equally robust, but also provided them with the assurance that this is something that they can rely on day in, day out. And so as we were developing this with their input, we were really looking at how do we make it easier for them to use as they're processing hundreds of units of platelets and plasma every day.

我認為從根本上來說，對於我們的客戶來說，他們真正依賴的是我們的供應鏈連續性以及我們系統的效能。因為正如您可能想像的那樣，由於他們在許多市場 100% 採用了我們的技術，如果出於某種原因，我們的供應鏈並不穩固，這意味著不僅在套件方面，而且在設備的操作方面，這會關閉他們的血液供應。從歷史上看，我們擁有一個非常可靠的系統，使用當前的 INT100 照明器，然後轉移到新的平台（如果您願意的話）使用這種基於 LED 的照明器。我們必須擁有同樣強大的東西，但也要向他們保證這是他們可以日復一日依賴的東西。因此，當我們根據他們的意見開發此產品時，我們真正考慮的是如何使他們更容易使用，因為他們每天要處理數百個單位的血小板和血漿。

And then sort of just thinking about in the context of decades, how do we have something that they feel is state-of-the-art and is not going to create problems for them in the future with regard to supply chain continuity. So I think the great thing about it is just the throughput and the ease-of-use feedback that we've gotten now as we've had numerous discussions with the European customers who will be receiving the LED illuminator in '25. The feedback is uniformly positive and it just -- it's easier for them from a staffing and day-to-day operational perspective. And then I also mentioned this. I do think it's a foundational platform for how we evolve the technology going forward that was built into it so that we have flexibility on how to improve the system and iterate on sort of the process, if you will, so that we ultimately have something that increases ease of use, but ultimately potentially impacts our COGS profile as well.

然後在幾十年的背景下思考，我們如何擁有他們認為最先進的東西，並且不會在未來為他們帶來供應鏈連續性方面的問題。因此，我認為它的偉大之處在於我們現在得到的吞吐量和易用性回饋，因為我們與將在 25 年接收 LED 照明器的歐洲客戶進行了多次討論。回饋一致都是正面的，而且從人員配置和日常營運的角度來看，這對他們來說更容易。然後我也提到了這一點。我確實認為它是我們如何發展內建技術的基礎平台，這樣我們就可以靈活地改進系統並迭代某種流程（如果你願意的話），以便我們最終擁有一些東西提高了易用性，但最終也可能影響我們的COGS 概況。

Got it. Super helpful. I'll leave it there. Thanks for taking the question.

知道了。超有幫助。我會把它留在那裡。感謝您提出問題。

(Operator Instructions) Joshua Jennings, TD Cowen.

（操作員說明）Joshua Jennings，TD Cowen。

It's great to see continued momentum. Two follow-ups. One on IFC. Sorry if I didn't capture this, but just wanted to get a sense of the rollouts of future BLA approvals. Are there any other blood center partners that are -- where BLAs are pending?

很高興看到持續的勢頭。兩個後續。國際金融公司 (IFC) 上有一張。抱歉，如果我沒有捕捉到這一點，我只是想了解未來 BLA 批准的推出情況。是否還有其他血液中心夥伴正在等待 BLA？

Should we expect more BLA approval announcements in the next 6, 12 months?

我們是否應該期待在未來 6、12 個月內發布更多 BLA 批准公告？

Yes. Thanks, Josh. And again, I'll turn it over to Vivek (inaudible) on IFC.

是的。謝謝，喬許。再次，我將把它交給 IFC 上的 Vivek（聽不清楚）。

So you have other blood center production partners who are in the process of pulling together BLA applications. Obviously, timing on that can vary. But we do anticipate more BLAs to come through in '25 and beyond. And -- but what's most exciting about the recent approvals is we believe that there -- with these approvals, there is sufficient capacity in terms of production headroom to allow us to continue to be aggressive in terms of driving demand. And that was something that we were always laser-focused on because we knew once we got to the fall Congress season with the papers that were being submitted for publication and the podium presentations that were being accepted, that there was going to be a flurry of new information release, both single center experience as well as broader data sets that supported IFC.

因此，您還有其他血液中心生產夥伴正在整理 BLA 申請。顯然，時間可能會有所不同。但我們確實預計 25 年及以後將會有更多 BLA。而且，最近的批准最令人興奮的是，我們相信，有了這些批准，生產空間就有足夠的能力，使我們能夠繼續積極推動需求。這是我們一直高度關注的事情，因為我們知道，一旦我們進入秋季國會季，提交出版的論文和接受的講台演講，就會出現一系列的問題。也有支持國際金融公司的更廣泛的數據集。

So we wanted to make sure that we're in a position that we could offer up the product once we knew people would start to say, hey, I want to bring that into my institution. So we'll continue to monitor this and work in lockstep to make sure one thing doesn't run too far ahead of the other. But right now, we feel like we're in a pretty solid position.

因此，我們希望確保一旦我們知道人們會開始說，嘿，我想將其引入我的機構，我們就可以提供該產品。因此，我們將繼續監控這一情況並齊心協力，確保一件事不會比另一件事走得太遠。但現在，我們感覺自己處於一個非常穩固的位置。

Excellent. And just wanted to just get a refresh on ASP for the LED illuminator. And just thinking about once that approval hits and there is this replacement cycle kicking in, will that have an impact on gross margins? I believe this is a gross margin accretive system, but I just wanted to check that box.

出色的。只是想更新一下 LED 照明器的 ASP。想想一旦獲得批准並且更換週期開始，這會對毛利率產生影響嗎？我相信這是一個毛利率增值系統，但我只是想選中該框。

Yes. Thanks a lot, Josh. I'll let Kevin (technical difficulty)

是的。非常感謝，喬許。我會讓凱文（技術難度）

Yes. Josh, we haven't really commented. I think it's a bit premature since we don't have approval yet for the LED illuminator. With that said, the technology is newer. The COGS will be slightly higher.

是的。喬希，我們還沒有真正發表評論。我認為現在還為時過早，因為我們還沒有獲得 LED 照明器的批准。話雖如此，這項技術是較新的。銷貨成本將略高。

And as a result, we expect the ASPs will be slightly higher. As far as a booster to overall gross margins, I think in and of itself, you shouldn't expect that. We expect that the margins on that product will be neutral to our current margin business. However, it does provide us with a platform for future growth, geographical expansion and in the future, potentially product iterations because of that platform. So hopefully, that answers your question.

因此，我們預計平均售價將略高。就整體毛利率的提升而言，我認為就其本身而言，你不應該指望這一點。我們預計該產品的利潤率對我們目前的利潤率業務來說是中性的。然而，它確實為我們提供了一個平台，用於未來的成長、地理擴張以及未來因該平台而可能進行的產品迭代。希望這能回答你的問題。

It does. And just one quick follow-up just on the IP side. This kind of extends some of that IP protection timeline is my understanding, too, but can you just refresh there?

確實如此。只是在 IP 方面進行快速跟進。我的理解是，這種方式會延長一些智慧財產權保護期限，但您能刷新嗎？

Yes, clearly there's a lot of IP that we've developed for this system over the course of the last five years. And it does extend, I think, the moat that we're building for the business. And it's obviously IP that we filed globally as well. So it improves the IP profile for the product for our global business.

是的，顯然我們在過去五年中為這個系統開發了許多 IP。我認為，它確實延伸了我們為業務打造的護城河。顯然，我們也在全球範圍內申請了智慧財產權。因此，它改善了我們全球業務產品的知識產權狀況。

Great. Thanks.

偉大的。謝謝。

(Operator Instructions) Mark Massaro, BTIG.

（操作員說明）Mark Massaro，BTIG。

This is Vidyun on for Mark. So just on the government contract revenue, I heard your remarks on why Q3 was a little bit light. How should we just think about the run rate or a good baseline here? And I just wanted to clarify, the newer BARDA contract should flow into our models more so looking to 2025.

我是 Vidyun 為 Mark 做的報道。因此，就政府合約收入而言，我聽到您關於為什麼第三季有點清淡的評論。我們應該如何考慮運行率或良好的基線？我只是想澄清一下，新的 BARDA 合約應該更多地流入我們的模型，因此展望 2025 年。

Yes. Thanks a lot, Vivien. And Kevin, do you want to handle that?

是的。非常感謝，薇薇安。凱文，你想解決這個問題嗎？

Sure. Yes, Vidyun. So let's take the 2016 contract in isolation. We had year-over-year lighter revenues because of the study completion. As the new sites with RedeS begin -- well, they have begun, but as they ramp up production, we expect that the revenues and the expenses associated will ramp up over the course of the next 12 to 15 months.

當然。是的，維迪雲。因此，讓我們單獨來看 2016 年的合約。由於研究的完成，我們的收入年減。隨著 RedeS 的新站點開始建設——好吧，它們已經開始建設，但隨著產量的增加，我們預計收入和相關費用將在未來 12 到 15 個月內增加。

At that same time, less so in Q4, but really in 2025, activities under the new 2024 BARDA contract will begin in earnest. There's $32 million committed over several years. And while we're not giving guidance on that, the activity certainly will start in 2025 and will ramp up. At the same time, the RedeS trial will complete, the 2016 contract will conclude, and then we'll be at a more plateaued level with ongoing initiatives under the new agreement.

同時，第四季度的情況有所減少，但實際上到 2025 年，新的 2024 年 BARDA 合約下的活動將認真開始。幾年內已承諾投入 3200 萬美元。雖然我們沒有就此提供指導，但該活動肯定會在 2025 年開始，並且會加速。同時，RedeS 試驗將完成，2016 年合約將結束，然後我們將在新協議下持續採取舉措，達到更穩定的水平。

Perfect. Understood. And then just one on the bottom line. I think adjusted EBITDA beat us. We saw some nice leverage there.

完美的。明白了。然後就只剩下最後一行了。我認為調整後的 EBITDA 擊敗了我們。我們在那裡看到了一些很好的槓桿作用。

It looks like you did maintain the full year guidance on that front, which seems a little bit conservative maybe. Is there any reason for that trend to change looking at Q4? Or just, I guess, what's driving the conservatism there?

看來你們確實維持了這方面的全年指導，這可能有點保守。從第四季來看，這種趨勢有什麼理由改變嗎？或者，我猜，是什麼推動了那裡的保守主義？

Yes, Vidyun. Well, our guidance was neutrality and we're tracking to slightly better than that, as you pointed out. No real reason for the conservatism other than there's a lot of moving parts and we don't want to get out ahead of ourselves. What we do expect is that with the increased revenue guidance, we would expect obviously growth there, sustaining our gross margins and continued leverage in operating expenses. There is variability in operating expenses and margins, as you know, though.

是的，維迪雲。嗯，我們的指導是中立的，正如您所指出的，我們的追蹤結果略好於這一水平。保守主義沒有真正的理由，只是有很多變化的部分，我們不想超越自己。我們確實預計，隨著收入指引的增加，我們預計該領域將出現顯著增長，從而維持我們的毛利率和營運支出的持續槓桿。不過，如您所知，營運費用和利潤率存在差異。

So we really want to hedge that as much as possible. But we are trending in the right direction and are optimistic about the future.

所以我們真的想盡可能地對沖這一點。但我們正朝著正確的方向發展，並對未來感到樂觀。

Perfect. Thanks for taking the question.

完美的。感謝您提出問題。

(Operator Instructions) Bill Bonello, Craig-Hallum.

（操作員說明）Bill Bonello，Craig-Hallum。

A little bit of a similar question to what you just got, but not in the context of guidance. Just, Kevin, can you help us think about sort of the sustainability of the cash flow from this point forward? Obviously, there'll be quarterly variability given working capital and whatnot. But are we sort of tracking to a $16 million cash flow run rate? What are sort of the puts and takes as we move forward here?

與您剛剛得到的問題有點相似，但不是在指導範圍內。只是，凱文，你能幫助我們思考一下從現在開始現金流的可持續性嗎？顯然，考慮到營運資金等因素，季度變化將會出現。但我們是否正在追蹤 1600 萬美元的現金流運行率？當我們繼續前進時，有哪些看跌期權和看跌期權？

Yes. Bill, I ask you to go back to our Q4/Q1 calls where we thought we would end this year was having the opportunity to generate operating cash flows. And that was a function of growth in the top line, management of our margins and OpEx getting continued leverage out of the investments that we've made. That's all happening. In addition, we felt like we had built so much inventory over the course of 2023 that we'd be in a position where we could convert some of those components and raw materials into finished kits without having to replenish that, and that would help the cash flows.

是的。比爾，我請你回到我們第四季/第一季的電話會議，我們認為今年年底我們將有機會產生營運現金流。這是營收成長、利潤管理和營運支出從我們的投資中獲得持續槓桿作用的結果。這一切都在發生。此外，我們覺得我們在 2023 年期間建立瞭如此多的庫存，我們可以將其中一些組件和原材料轉換成成品套件，而無需補充，這將有助於現金流量。

That certainly has played out as you look at our balance sheet. We also said at that time in 2025, we'll have to rebuild the working capital and the inventory to meet growing demand. But we also expect that the business will be at a run rate where those investments in working capital will be offset with just natural operating bottom line. So I don't want to comment on what you should expect as far as cash flow generation long term, just the qualitative levers that we're looking at and that we're pulling to make sure that we're managing things appropriately and that our balance sheet remains healthy.

當你看看我們的資產負債表時，這肯定已經發生了。我們當時也表示，到 2025 年，我們將不得不重建營運資金和庫存，以滿足不斷增長的需求。但我們也預計，該業務的運作速度將足以抵銷這些營運資本投資的自然營運利潤。因此，我不想評論您對長期現金流產生的預期，只是我們正在考慮的定性槓桿，以及我們正在採取的措施，以確保我們適當地管理事物，並且我們的資產負債表保持健康。

And do we think of -- in terms of product development uptick, do we think of that as almost being -- to what degree is that fully funded because of your BARDA relationship? And to what degree do you bear the burden of additional R&D expenses?

我們是否認為——就產品開發的成長而言，我們是否認為這幾乎是——由於你們與 BARDA 的關係而得到了充分資助？您承擔額外研發費用的負擔有多大？

Well, it's certainly a significant -- almost a majority of our R&D expenses are funded by BARDA. That's especially true today with multiple BARDA agreements. We also have the whole blood initiative with the FDA and the lyophilized IFC. So that is a major component of our overall R&D expense. The remaining items are initiatives that are foundational to our future growth and revenue trajectory, like the LED illuminator.

嗯，這當然是一個重要的——我們幾乎大部分研發費用都是由 BARDA 資助的。如今簽署多項 BARDA 協議尤其如此。我們也與 FDA 和凍乾 IFC 簽訂了全血倡議。所以這是我們整體研發費用的主要組成部分。其餘項目是我們未來成長和收入軌蹟的基礎舉措，例如 LED 照明器。

I expect that, that mix will continue as we move forward. We don't think there's going to be drastic swings in R&D expense as we move into 2025. But we're not done planning and we're not providing guidance today.

我預計，隨著我們的前進，這種混合將繼續下去。我們認為，進入 2025 年，研發費用不會大幅波動。但我們的計劃尚未完成，今天也不提供指導。

Okay. And then just other -- and again, not guidance, but other uses of cash that we should be thinking about going forward in terms of capital expense or et cetera?

好的。然後是其他——再說一次，不是指導，而是我們應該考慮在資本支出等方面未來的現金其他用途？

Well, clearly, the working capital items that we commented on, we maintain the revolving line of credit for that exact reason. It's down year-over-year as we ended 9/30/24. We'll continue to look at the opportunities to leverage that and offset any balance sheet cash that we would have to fund for that. And then beyond probably CapEx on COGS reduction initiatives and capacity expansion initiatives. Lastly, I'd say geographic expansion to the extent that we have the opportunity to expand geographically, place devices, those are are all high-return investments that we think would be beneficial to shareholders.

嗯，很明顯，我們評論過的營運資金項目，正是出於這個原因，我們維持了循環信貸額度。截至 2024 年 9 月 30 日，該數字年減。我們將繼續尋找利用這一點的機會，並抵消我們必須為此提供資金的任何資產負債表現金。然後可能超出了銷貨成本削減計劃和產能擴張計劃的資本支出。最後，我想說的是地理擴張，我們有機會擴張地域、放置設備，這些都是我們認為對股東有利的高回報投資。

Okay. Thanks a lot.

好的。多謝。

And I'm not showing any further questions at this time. I'd like to turn the call back over to Obi for any closing remarks.

目前我不會提出任何進一步的問題。我想將電話轉回給奧比，讓他作結束語。

Well, thank you all again for joining us today and for your interest in Cerus. Later this year, we'll be participating in investor conferences hosted by Stifel, Stephens and Craig-Hallum, after which we look forward to speaking with you again in the new year. Thanks again.

好吧，再次感謝大家今天加入我們以及對 Cerus 的興趣。今年晚些時候，我們將參加由 Stifel、Stephens 和 Craig-Hallum 主辦的投資者會議，之後我們期待在新的一年再次與您交談。再次感謝。

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

女士們、先生們，今天的演講到此結束。您現在可以斷開連接並度過美好的一天。