Cerus Corp (CERS) 2023 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 2023 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to Jessica Hanover, Cerus' Vice President of Corporate Affairs. Dr. Hanover, you may begin.

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 2023 年第二季財報電話會議。 （操作員指示）請注意，今天的會議正在錄製中。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. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cerus.com.

謝謝你，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。

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; Dr. Nina Mufti, Cerus' Vice President of Development and Red Blood Cell Program leader; Dr. Richard Benjamin, Cerus' Chief Medical Officer; Dr. Laurence Corash, Cerus' Chief Scientific Officer; and Carol Moore, Cerus' Senior Vice President of Regulatory Affairs and Quality.

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； Nina Mufti 博士，Cerus 開發副總裁兼紅血球專案負責人； Richard Benjamin 博士，Cerus 首席醫療官； Cerus 首席科學官 Laurence Corash 博士； Cerus 監管事務和品質高級副總裁 Carol Moore。

Cerus issued a press release today announcing our financial results for the second quarter ended June 30, 2023, 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 related to future events and performance rather than historical facts and are forward-looking statements.

Cerus 今天發布新聞稿，公佈了截至 2023 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。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，並且是前瞻性聲明。

Examples of forward-looking statements include those related to our future financial and operating results, including our updated 2023 product revenue guidance, expected operating expense savings, our adjusted EBITDA goal and future operating expenses as well as our commercial development efforts, expected future growth and our growth strategy, future product sales, potential product launches, ongoing and future clinical trials, ongoing and future product development and our regulatory plans and initiatives and related expectations, including the timing of these events and activities.

前瞻性陳述的例子包括與我們未來財務和營運績效相關的陳述，包括我們更新的2023 年產品收入指導、預期營運費用節省、我們調整後的EBITDA 目標和未來營運費用以及我們的商業開發努力、預期未來成長和我們的成長策略、未來的產品銷售、潛在的產品發布、正在進行和未來的臨床試驗、正在進行和未來的產品開發以及我們的監管計劃和舉措以及相關期望，包括這些事件和活動的時間安排。

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 and under Risk Factors in our Form 10-Q for the quarter ended June 30, 2023, 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，可能導致實際事件的表現和結果有重大差異。它們在今天的新聞稿中以及我們將很快提交的截至 2023 年 6 月 30 日的季度的 10-Q 表格中的風險因素中進行了識別和描述。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.

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。

We'll begin today with opening remarks from Obi, followed by Vivek to discuss recent business highlights and Kevin to review our financial results and expectations for 2023. 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，隨後由 Vivek 討論最近的業務亮點，Kevin 回顧我們的財務表現和 2023 年的預期。現在我很高興向大家介紹 Cerus 總裁兼首席執行官 Obi Greenman。

Thank you, Jessica, and good afternoon, everyone. Today, I would like to begin the call with a commentary about the progress we have made in Q2 across our full INTERCEPT portfolio combined with the ongoing expansion of our commercial business.

謝謝你，潔西卡，大家下午好。今天，我想在電話會議開始時評論我們在第二季度在整個 INTERCEPT 產品組合中取得的進展以及我們商業業務的持續擴張。

Most significantly, during the second quarter, we gained new visibility into the European and U.S. timelines for our INTERCEPT red blood cell program. In the EU, as you will recall, we previously received questions from our competent authority, CBG, MEB or MEB as part of our overall MDR process for our EU submission for CE Mark approval. Due to the work led for regulatory authorities associated with the new MDR process for device approvals in the EU, it was late June when we were able to have a clarification meeting with MEB to review our strategy for addressing their questions.

最重要的是，在第二季度，我們對歐洲和美國 INTERCEPT 紅血球計畫的時間表有了新的了解。您可能還記得，在歐盟，我們之前曾收到來自主管機關、CBG、MEB 或 MEB 的問題，這是我們提交歐盟 CE 標誌批准的整體 MDR 流程的一部分。由於監管機構需要進行與歐盟設備審批新 MDR 流程相關的工作，因此我們在 6 月下旬與 MEB 召開了澄清會議，審查我們解決他們問題的策略。

The meeting was very positive and confirmed our approach for addressing MEB's questions asound and on point. Based on the discussion of this meeting, we expect the MEB will accept our comprehensive responses to their questions in Q4 of this year.

這次會議非常積極，並確認了我們正確、切題地解決 MEB 問題的方法。根據本次會議的討論，我們預計 MEB 將在今年第四季接受我們對其問題的全面答覆。

Assuming no further issues are identified by MEB, we expect them to prepare a positive opinion, which they will provide to our notified body, TUV in the first half of next year through the MDR process. Because the TUV has already completed its initial review of all modules of our submission, we would then expect a CE Mark approval decision in the second half of 2024, which, if approved, will enable the rollout of the product associated with the requisite hemovigilance program at multiple sites across Europe.

假設 MEB 沒有發現更多問題，我們預計他們會準備一份積極的意見，並在明年上半年透過 MDR 流程向我們的公告機構 TUV 提供。由於 TUV 已經完成了對我們提交的所有模組的初步審查，我們預計將在 2024 年下半年做出 CE 標誌批准決定，如果獲得批准，將能夠推出與必要的血液警戒計劃相關的產品在歐洲多個地點。

Also in June, we held a scientific advisory board meeting for INTERCEPT red blood cells with leaders in the field of transfusion medicine. During this meeting, we gained valuable insights into existing unmet needs for anemia patients requiring chronic red cell transfusions and the value proposition of pathogen reduced red blood cells.

同樣在 6 月，我們與輸血醫學領域的領導者舉行了 INTERCEPT 紅血球科學顧問委員會會議。在這次會議上，我們對需要長期紅血球輸注的貧血患者現有的未滿足需求以及病原體減少紅血球的價值主張獲得了寶貴的見解。

Coming out of this meeting, we continue to believe in the product profile and the immediate clinical need for patients receiving chronic red cell transfusions. The ability to replace gamma radiation and its associated deleterious impact on red blood cell function is a key attribute of the INTERCEPT process.

從這次會議中得出，我們仍然相信產品概況以及接受慢性紅血球輸注的患者的直接臨床需求。替代伽馬輻射的能力及其對紅血球功能的相關有害影響是攔截過程的關鍵屬性。

Turning to the U.S. RBC program. Our 2 U.S. BARDA-funded Phase III trials, ReCePI and RedeS continued to enroll patients at a good rate. The 309 patients now enrolled and transfused in ReCePI, we expect to complete enrollment this year. With patients remaining on study for 90 days after their transfusion event, we are planning on a database lock and an initial top line data readout from this trial in Q1 of 2024.

轉向美國 RBC 計劃。我們的 2 個由美國 BARDA 資助的 III 期試驗 ReCePI 和 RedeS 繼續以良好的速度招募患者。目前已有 309 名患者入組並接受 ReCePI 輸血，我們預計今年將完成入組。由於患者在輸血事件後仍在研究 90 天，我們計劃在 2024 年第一季鎖定資料庫並讀取該試驗的初始頂線資料。

Based on the ongoing enrollment in our second U.S. Phase III trial, RedeS, we now plan to begin the modular PMA submission in H2 2025, and the last module being the clinical one planned for H2 2026. With respect to our earlier stage pipeline, as we announced in June, we received additional funding of more than $8 million from the U.S. Department of Defense to support the ongoing development of lyophilized INTERCEPT Fibrinogen Complex or LyoIFC.

根據我們第二個美國III 期試驗RedeS 的持續入組情況，我們現在計劃在2025 年下半年開始模組化PMA 提交，最後一個模組是計劃在2026 年下半年進行臨床模組。關於我們的早期階段管道，我們在 6 月宣布，我們從美國國防部獲得了超過 800 萬美元的額外資金，以支持冷凍乾燥 INTERCEPT 纖維蛋白原複合物或 LyoIFC 的持續開發。

Since receiving the initial DoD funding award in November 2022, we have successfully scaled up the lyophilization process, provided prototype materials for evaluation to the DoD and met with the FDA to define the regulatory pathway for LyoIFC to include additional manufacturing steps and design of preclinical and clinical studies.

自2022 年11 月獲得國防部首次資助以來，我們成功擴大了冷凍乾燥工藝規模，向國防部提供了用於評估的原型材料，並與FDA 會面，確定了LyoIFC 的監管途徑，包括額外的製造步驟以及臨床前和臨床前和臨床試驗的設計。臨床研究。

The additional contract we have now been awarded is anticipated to support the implementation of manufacturing processes required by the FDA, continued scale-up of manufacturing technology for the LyoIFC products and development of data to support a submission to the FDA designed to enable initiation of preclinical and clinical studies. We've also continued to work on our LED-based next-generation illuminator. During the International Society of Blood Transfusion or ISBT Congress in Gothenburg, Sweden, held in person in June for the first time since 2019, we hosted customer-focused group meetings with over 30 blood bankers for more than a dozen centers. We are pleased with the excitement from the group during the hands-on demonstration of the new device and grateful for the important feedback that our customers have provided over the last several years to guide development.

我們現在獲得的額外合約預計將支持 FDA 要求的製造流程的實施、LyoIFC 產品製造技術的持續擴大以及數據的開發，以支持向 FDA 提交旨在啟動臨床前試驗的數據。和臨床研究。我們也繼續致力於開發基於 LED 的下一代照明器。 6 月，國際輸血協會 (ISBT) 在瑞典哥德堡舉行了自 2019 年以來首次面對面舉行的會議，期間，我們與十多個中心的 30 多名血庫工作人員舉辦了以客戶為中心的小組會議。我們對團隊在新設備的實際演示過程中表現出的興奮感到高興，並感謝我們的客戶在過去幾年中為指導開發提供的重要回饋。

In addition, our EFS research collaborators in France gave an independent oral presentation at the ISBT Congress, demonstrated the comparability of the LED illuminator with the current INT-100 illuminator. This new illuminator will serve as a platform for our future product iterations over the coming decade and the intellectual property position and improved customer operating experience furthers our leadership role in the transfusion medicine field.

此外，我們在法國的EFS研究合作者在ISBT大會上進行了獨立口頭報告，展示了LED照明器與目前INT-100照明器的可比性。這款新型照明器將作為我們未來十年產品迭代的平台，智慧財產權地位和改進的客戶操作體驗進一步鞏固了我們在輸血醫學領域的領導地位。

With respect to our commercial business, we emerged from a challenging first half to expectations of growth for the rest of the year and into 2024. Vivek will provide more insights in his commentary following mine. We expect INTERCEPT Fibrinogen Complex or IFC to play an increasingly important role as we make strong progress with our newest production partner, OneBlood and advance discussions with even larger U.S. blood centers for this product.

就我們的商業業務而言，我們度過了充滿挑戰的上半年，預計今年剩餘時間和 2024 年將實現增長。Vivek 將在我的評論中提供更多見解。我們預計 INTERCEPT 纖維蛋白原複合物或 IFC 將發揮越來越重要的作用，因為我們與最新的生產合作夥伴 OneBlood 取得了巨大進展，並與更大的美國血液中心就該產品進行了進一步的討論。

We are encouraged by the recent addition of pathogen-reduced cryoprecipitate to the World Health Organization, or WHO, essential medicines list because it provides additional global validation for the utility of our IFC product. We look forward to providing updates on our continued progress for our pipeline and commercial business in future calls.

最近，世界衛生組織 (WHO) 基本藥物清單中添加了減少病原體的冷沉澱劑，這讓我們感到鼓舞，因為它為我們的 IFC 產品的效用提供了額外的全球驗證。我們期待在未來的電話會議中提供有關我們的管道和商業業務持續進展的最新資訊。

I would now like to turn the call over to Vivek to discuss the second quarter commercial highlights and the outlook for the remainder of the year.

我現在想將電話轉給 Vivek，討論第二季的商業亮點和今年剩餘時間的前景。

Thank you, Obi, and good afternoon to everyone joining on today's call. As reported in our press release earlier today, our total product revenue for the second quarter of 2023 was up significantly from the first quarter, showing sequential growth of 25%. Within the quarter, we experienced an impact on our U.S. customer ordering patterns associated with the temporary reduction in the FDA-approved shelf life for INTERCEPT platelet kits. Due to a recent component change, the FDA required 6-month shelf life for the kit, which led to customers rebalancing their inventory levels in order to minimize obsolescence. We did not see any reduction in share during the period, but the efforts to rightsize inventory levels did affect ordering patterns.

謝謝你，奧比，祝參加今天電話會議的所有人下午好。正如我們今天稍早發布的新聞稿中所報導的，我們 2023 年第二季的產品總收入較第一季大幅成長，季增 25%。在本季度內，我們的美國客戶訂購模式受到了影響，原因是 FDA 批准的 INTERCEPT 血小板試劑盒保質期暫時縮短。由於最近的成分變化，FDA 要求該套件有 6 個月的保質期，這導致客戶重新平衡其庫存水平，以盡量減少過時。在此期間，我們沒有看到份額有任何減少，但調整庫存水準的努力確實影響了訂購模式。

This shelf life issue is unique to the U.S. market because the other regulatory bodies in Europe and elsewhere did not see the need for real-time stability studies for this component change to the kit. We are actively pursuing a regulatory filing plan to be submitted to the FDA later this year designed to extend the kit shelf life to 9 months within the first quarter of 2024 and then follow with further improvement in shelf life [gaining] quarterly throughout the remainder of next year. We believe this will alleviate the impact on customers and allow normal ordering patterns to resume supporting our expected return to growth.

這個保質期問題是美國市場所特有的，因為歐洲和其他地方的其他監管機構認為沒有必要對套件中的這種成分變化進行即時穩定性研究。我們正在積極尋求一項監管備案計劃，該計劃將於今年稍後提交給FDA，旨在在2024 年第一季內將試劑盒的保質期延長至9 個月，然後在剩餘的時間內每季度進一步延長保質期。明年。我們相信，這將減輕對客戶的影響，並使正常的訂購模式恢復，支持我們預期的成長回報。

Looking at the overall U.S. market, INTERCEPT-treated platelets continued to be a leading choice for patient transfusion safety, and we have many strong blood center partners who are or are on the way to becoming 100% pathogen-reduced platelet producers.

縱觀整個美國市場，INTERCEPT 處理的血小板仍然是患者輸血安全的主要選擇，我們有許多強大的血液中心合作夥伴，他們正在或正在成為 100% 病原體減少的血小板生產商。

The recent FDA guidance on production of cold-stored platelets for patients with active bleeding includes an option for preparation with INTERCEPT, providing added manufacturing flexibility to our customers with extension to 14-day shelf life. This new development will improve the availability of INTERCEPT platelets to help alleviate recent constraints in the U.S. platelet supply.

FDA 最近關於為活動性出血患者生產冷藏血小板的指南包括使用 INTERCEPT 進行製備的選項，為我們的客戶提供了更大的生產靈活性，並將保質期延長至 14 天。這項新進展將提高 INTERCEPT 血小板的可用性，以幫助緩解美國近期血小板供應的限制。

We continue to see increased INTERCEPT adoption at leading hospitals across the country as the awareness of the clinical benefits of pathogen reduction build. Beyond simply the FDA bacterial safety guidance compliance, pathogen-reduced platelets offer unmatched protection against a wide range of potential infectious threats.

隨著人們對減少病原體的臨床益處的認識不斷增強，我們繼續看到全國領先醫院越來越多地採用 INTERCEPT。除了符合 FDA 細菌安全指南之外，病原體減少的血小板還可以針對各種潛在的感染威脅提供無與倫比的保護。

We remain committed to ongoing partnership with our U.S. blood center customers to ensure that they can provide their hospital customers with the best possible product.

我們仍然致力於與美國血液中心客戶保持持續的合作關係，以確保他們能夠為醫院客戶提供最好的產品。

Outside of the U.S., we continue to be pleased with the ongoing rollout of INTERCEPT platelets by Canadian Blood Services or CBS. More than 25% of all CBS platelets are currently INTERCEPT treated with 4 of their 8 manufacturing sites now live with INTERCEPT, and activities are on track to complete the rollout in the first half of next year. Our ongoing validation work with Hema-Quebec is going well, and we are excited to broaden access to pathogen reduced platelets to our neighbors (inaudible).

在美國以外，我們仍然對加拿大血液服務中心 (CBS) 持續推出 INTERCEPT 血小板感到滿意。目前，超過 25% 的 CBS 血小板均經過 INTERCEPT 處理，其 8 個生產基地中有 4 個已採用 INTERCEPT，各項活動預計在明年上半年完成部署。我們與 Hema-Quebec 正在進行的驗證工作進展順利，我們很高興能夠擴大鄰居獲得病原體減少血小板的機會（聽不清楚）。

In Europe, we experienced some acute headwinds in France and Belgium due to a reduction in platelet collections related to donor availability. As you will rightly recall, these countries utilized pathogen reduction to safeguard 100% of their platelet supply. So we saw no impact on INTERCEPT's share in these regions.

在歐洲，由於與捐贈者可用性相關的血小板採集量減少，我們在法國和比利時遇到了一些嚴重的阻力。您應該記得，這些國家利用減少病原體來保障 100% 的血小板供應。因此，我們認為 INTERCEPT 在這些地區的份額沒有受到影響。

Also during the quarter, new sanctions in Russia impacted our EMEA franchise. We are in the process of applying for a license to account for these sanctions and continue to monitor the situation closely to ensure that we can help patients gain access to our technology.

同樣在本季度，俄羅斯的新制裁影響了我們在歐洲、中東和非洲的特許經營權。我們正在申請許可證以應對這些制裁，並繼續密切監視事態發展，以確保我們能夠幫助患者獲得我們的技術。

We continue to see strong interest in IFC. We are now fully staffed on the sales side and are able to access many more hospitals to drive awareness and demand. In parallel, we are working closely with our blood center production partners to ensure that supply is available and demand increases. Most recently, our partnership with OneBlood has been particularly productive as their commitment to making IFC accessible to hospital customers has been strong.

我們繼續看到人們對國際金融公司的濃厚興趣。我們現在在銷售方面人員配備齊全，並且能夠接觸更多的醫院來提高認知和需求。同時，我們正在與血液中心生產合作夥伴密切合作，以確保供應充足和需求增加。最近，我們與 OneBlood 的合作特別富有成效，因為他們堅定地致力於讓醫院客戶能夠使用 IFC。

We look to replicate this experience with other partnerships. And to this end, we are in discussions with other large U.S. blood centers for IFC. On the hospital provider side, the level of clinical interest in IFC is encouraging, and we continue to see major medical centers on board the product.

我們希望與其他合作夥伴複製這項經驗。為此，我們正在與國際金融公司其他大型美國血液中心進行討論。在醫院提供者方面，對 IFC 的臨床興趣程度令人鼓舞，我們繼續看到主要醫療中心使用該產品。

During the quarter, as Obi noted, we enjoyed a very strong showing at the recent ISBT Congress in Gothenburg, Sweden. At the Congress, we were able to engage with many of our customers, clinical trial partners and industry collaborators and gain substantial positive feedback with respect to the complete INTERCEPT product portfolio.

正如 Obi 指出的那樣，本季我們在最近於瑞典哥德堡舉行的 ISBT 大會上取得了非常強勁的表現。在大會上，我們能夠與許多客戶、臨床試驗合作夥伴和產業合作者進行交流，並獲得大量有關完整 INTERCEPT 產品組合的正面回饋。

During the scientific sessions, there were several INTERCEPT focused talks in which users presented compelling data focused both on their routine use experiences with INTERCEPT as well as developmental programs such as the LED illuminator and INTERCEPT RBCs. Dr. Graham Sher, CEO of Canadian Blood Services provided positive feedback about their journey to date in deploying INTERCEPT platelets across their service area.

在科學會議期間，有幾次以 INTERCEPT 為重點的演講，其中用戶提供了令人信服的數據，重點關注他們的 INTERCEPT 日常使用體驗以及 LED 照明器和 INTERCEPT RBC 等開發計劃。加拿大血液服務公司首席執行官 Graham Sher 博士對迄今為止在其服務區域部署 INTERCEPT 血小板的歷程提供了積極的反饋。

Taking a step back, it is clear that we continue to make meaningful strides across the globe and are accruing meaningful wins as we push to ensure access to safe blood products. While we saw strong sequential growth in Q2, we still face some headwinds in our commercial franchise. That said, we remain optimistic about the outlook for the second half of 2023 and for the resumption of meaningful growth in the years to come. With each passing quarter, we can see more real-world validation and clinical benefits of pathogen reduction for platelets. And while we would love for things to move faster, we are experiencing real momentum in our U.S. IFC franchise. I look forward to providing updates on our progress in the coming quarters.

退後一步，很明顯，我們繼續在全球範圍內取得有意義的進步，並在努力確保獲得安全血液製品的過程中取得有意義的勝利。儘管我們在第二季度看到了強勁的連續成長，但我們的商業特許經營權仍然面臨一些阻力。儘管如此，我們對 2023 年下半年的前景以及未來幾年恢復有意義的成長仍持樂觀態度。每個季度，我們都可以看到更多的現實世界驗證和減少血小板病原體的臨床益處。雖然我們希望事情進展得更快，但我們在美國國際金融公司的特許經營權正在經歷真正的勢頭。我期待在未來幾個季度提供有關我們進展的最新資訊。

I will now turn it over to Kevin to discuss our results and outlook in more detail.

我現在將把它交給凱文，更詳細地討論我們的結果和前景。

Thanks, Vivek, and good afternoon, everyone. Today, I will be discussing our financial results for the second quarter, our product revenue guidance for the year and our progress on the levers we have and will continue to utilize as we work towards reaching adjusted EBITDA breakeven by the end of this year. We posted second quarter 2023 product revenue of $38.9 million, representing a year-over-year decrease of 5%, primarily due to the factors noted by Vivek earlier.

謝謝維韋克，大家下午好。今天，我將討論我們第二季度的財務業績、我們今年的產品收入指引，以及我們在努力在今年年底前實現調整後 EBITDA 盈虧平衡的過程中，我們已經並將繼續利用的槓桿方面的進展。我們公佈的 2023 年第二季產品收入為 3,890 萬美元，年減 5%，這主要是由於 Vivek 先前指出的因素所致。

In the U.S., product revenues were slightly down by 5% year-over-year, but sequentially, we saw a significant step up from Q1 of 45%, confirming our earlier expectations that the business would begin to see a rebound to more historical levels of growth.

在美國，產品收入年比小幅下降 5%，但我們看到較第一季 45% 的大幅成長，證實了我們先前的預期，即業務將開始反彈至歷史水平的成長。

In EMEA, product revenues were down 9% year-over-year and 4% sequentially. Year-over-year, FX rates provided a slight benefit of around 800 basis points. In addition to our product revenue and not included in our guidance, government contract revenue totaled $8.9 million in Q2 compared to $6.6 million for the prior year period. Included in our government contract revenue are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further whole-blood pathogen reduction and our agreement with the U.S. Department of Defense for LyoIFC.

在歐洲、中東和非洲地區，產品收入年減 9%，較上季下降 4%。與去年同期相比，匯率小幅上漲約 800 個基點。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 890 萬美元，而去年同期為 660 萬美元。我們的政府合約收入包括根據我們與 BARDA 的合約、我們與 FDA 進一步減少全血病原體的協議以及我們與美國國防部就 LyoIFC 達成的協議確認為報銷的收入。

As noted in our earnings release, we are pleased that during Q2, the DoD has agreed to increase the funding and scope of this program and awarded us with an additional $8.7 million, bringing the total contract value to $17.8 million.

正如我們的財報中所指出的，我們很高興第二季期間，國防部同意增加該計劃的資金和範圍，並向我們額外授予 870 萬美元，使合約總價值達到 1780 萬美元。

Turning now to our product gross profit and gross margins. Our second quarter product gross profit was $21.3 million, consistent with the prior year period. Product gross margins for the quarter were 54.9%, a 300 basis point increase versus the prior year period and generally stable from Q1.

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 2,130 萬美元，與去年同期持平。本季產品毛利率為 54.9%，較去年同期成長 300 個基點，與第一季基本持平。

Moving on. Our second quarter operating expenses, which totaled $41.9 million were $7.1 million higher than the prior year period and included $5.7 million in noncash stock-based compensation. By specific expense side, second quarter R&D expense totaled $19.2 million compared to $15.2 million during the prior year period.

繼續。我們第二季的營運支出總計 4,190 萬美元，比去年同期增加 710 萬美元，其中包括 570 萬美元的非現金股票薪資。從具體支出來看，第二季研發支出總計 1,920 萬美元，而去年同期為 1,520 萬美元。

We had increased R&D activity for the development of our next-generation illuminator, along with increased government reimbursed activity associated with our BARDA, FDA and DoD agreements. In addition, we recorded increased costs associated with developing data and answering questions from regulatory agencies, namely the FDA surrounding our existing products.

我們增加了開發下一代照明器的研發活動，同時增加了與我們的 BARDA、FDA 和 DoD 協議相關的政府報銷活動。此外，我們也記錄了與開發數據和回答監管機構（即 FDA 圍繞我們現有產品）提出的問題相關的成本增加。

Second quarter SG&A expense was $20.5 million compared to $19.5 million during the prior year period. The increase in SG&A expense was primarily driven by higher sales personnel to drive acceleration of our IFC business and, to a lesser extent, general inflationary impacts. Also included in our operating expenses for the second quarter was a onetime restructuring charge of $2.1 million related to a modest reorganization of resources during the quarter, providing us with additional operating flexibility to bolster our drive towards adjusted EBITDA breakeven.

第二季 SG&A 費用為 2,050 萬美元，去年同期為 1,950 萬美元。銷售管理費用的增加主要是由於銷售人員的增加，以推動我們的國際金融公司業務的加速，以及在較小程度上的整體通膨影響。我們第二季的營運費用還包括 210 萬美元的一次性重組費用，該費用與本季度資源的適度重組有關，這為我們提供了額外的營運靈活性，以支持我們實現調整後 EBITDA 盈虧平衡。

We expect to take another restructuring charge in Q3 as we cease use of certain leased real estate as part of the comprehensive restructuring plan. Going forward, we estimate that the cumulative effect of these initiatives will generate approximately $10 million in operating expense savings on an annualized basis.

作為全面重組計劃的一部分，我們預計將在第三季收取另一項重組費用，因為我們將停止使用某些租賃房地產。展望未來，我們估計這些措施的累積效應將每年節省約 1,000 萬美元的營運費用。

On the bottom line, reported net loss attributable to Cerus for the 3 months ended June 30, 2023, was notably higher when compared to the same period in 2022. Net loss attributable to Cerus for Q2 totaled $13.3 million or $0.07 per diluted share compared to $8.4 million or $0.05 per diluted share for the prior year period. Higher operating expenses, including the impact of the restructuring charge, were largely responsible for the increased net loss. We expect this trend to reverse itself as we move forward with anticipated higher revenue comps, improving gross margins and moderated operating expenses.

總而言之，截至 2023 年 6 月 30 日的三個月，Cerus 報告的淨虧損明顯高於 2022 年同期。第二季 Cerus 淨虧損總計 1,330 萬美元，攤薄後每股虧損 0.07 美元。上一年期間稀釋後每股840 萬美元或0.05 美元。較高的營運費用，包括重組費用的影響，是淨虧損增加的主要原因。我們預計，隨著我們預期更高的收入比較、毛利率的提高和營運費用的降低，這種趨勢將會逆轉。

Moving on to our adjusted EBITDA metric. Second quarter non-GAAP adjusted EBITDA totaled negative $4.7 million compared to a negative $2.4 million during the second quarter of 2022 and negative $9.8 million during the first quarter of this year. On a year-to-date basis, our non-GAAP adjusted EBITDA decreased in the first half of 2023 to a negative $14.5 million compared to a negative $6.1 million in the first half of 2022.

接下來討論我們調整後的 EBITDA 指標。第二季非 GAAP 調整後 EBITDA 總計為負 470 萬美元，而 2022 年第二季為負 240 萬美元，今年第一季為負 980 萬美元。年初至今，我們的非 GAAP 調整後 EBITDA 在 2023 年上半年下降至負 1,450 萬美元，而 2022 年上半年為負 610 萬美元。

As we look to the second half of the year and beyond, we are reaffirming our efforts to achieve adjusted EBITDA breakeven this year. We expect the second half will provide a return to year-over-year growth in our top line, and we expect fairly stable gross margins. As I noted earlier, we undertook a restructuring effort during the second quarter with an eye on our key commercial priorities and development initiatives. We expect this restructuring will provide some relief to our operating expenses and cash flows. And taken in combination, we believe the aforementioned are foundational components to meeting our adjusted EBITDA goal.

展望今年下半年及以後，我們重申今年將努力實現調整後 EBITDA 損益平衡。我們預計下半年我們的營收將恢復年增，我們預計毛利率將相當穩定。正如我之前指出的，我們在第二季度進行了重組工作，並著眼於我們的關鍵商業優先事項和發展計劃。我們預計此次重組將在一定程度上緩解我們的營運費用和現金流。綜合起來，我們相信上述內容是實現我們調整後的 EBITDA 目標的基礎組成部分。

Turning to the balance sheet and cash flows. We ended the second quarter with a strong cash position of $84.5 million cash, cash equivalents and short-term investments on the balance sheet. In terms of cash utilization, our cash used from operations was $7.6 million for the second quarter compared to approximately $350,000 during the prior year period.

轉向資產負債表和現金流量。截至第二季末，我們資產負債表上的現金、現金等價物和短期投資擁有 8,450 萬美元的強勁現金部位。在現金利用率方面，第二季我們的營運現金使用量為 760 萬美元，而去年同期約為 35 萬美元。

Clearly, the first half provided some operational challenges, we expect will reverse in the second half of the year. From a cash flow perspective, a byproduct of those challenges was an overproduction of inventory, as you can see on our balance sheet. We are moderating production in the second half of the year and expect that with the anticipated growth in sales, we will reverse this cash flow trend by monetizing the first half overproduction.

顯然，上半年帶來了一些營運挑戰，我們預計下半年將出現逆轉。從現金流的角度來看，這些挑戰的副產品是庫存過剩，正如您在我們的資產負債表上看到的那樣。我們將在下半年放緩生產，並預計隨著預期的銷售成長，我們將透過將上半年的生產過剩貨幣化來扭轉這種現金流趨勢。

Given the changes in U.S. customer ordering patterns related to the temporary impact of the platelet kit reduced shelf life, coupled with market dynamics in France, Belgium and Russia, we are adjusting down our full year 2023 product revenue guidance to a range of $160 million to $165 million. We want to point out that we have not lost market share and continue to see strong demand for INTERCEPT platelets in the U.S. and EMEA, and we believe that we remain on a trajectory to return to growth in the back half of the year and into next.

鑑於美國客戶訂購模式的變化與血小板試劑盒保質期縮短的暫時影響有關，再加上法國、比利時和俄羅斯的市場動態，我們將 2023 年全年產品收入指引下調至 1.6 億美元至1.65 億美元。我們想指出的是，我們並沒有失去市場份額，並且繼續看到美國和歐洲、中東和非洲地區對 INTERCEPT 血小板的強勁需求，我們相信，我們仍然走在今年下半年和明年恢復增長的軌道上。

Furthermore, as I previously mentioned, we remain committed to achieving adjusted EBITDA breakeven by year-end 2023. And in light of lowered product revenue guidance and continued macroeconomic conditions, we have been and will continue to be very focused on aligning our operating expenses with our key priorities, which include ongoing capacity expansion and supply chain security and global regulatory submissions for our next-generation LED illuminator and potential red blood cell licensure in EMEA, along with government reimbursed activities; and last but not least, support of our commercial infrastructure. With that, let me turn the call back over to the operator for Q&A.

此外，正如我之前提到的，我們仍然致力於在 2023 年底前實現調整後 EBITDA 盈虧平衡。鑑於產品收入指導的降低和持續的宏觀經濟狀況，我們一直並將繼續非常注重使我們的營運費用與我們的主要優先事項，包括持續的產能擴張和供應鏈安全、下一代LED 照明器的全球監管提交和歐洲、中東和非洲地區潛在的紅血球許可，以及政府報銷的活動；最後但並非最不重要的一點是對我們商業基礎設施的支援。接下來，讓我將電話轉回給接線生進行問答。

Thank you. We will now conduct the question-and-answer session. (Operator Instructions) Our first question comes from the line of Jacob Johnson of Stephens. Your line is now -- our first question comes from the line of Jacob Johnson of Stephens.

謝謝。我們現在將進行問答環節。 （操作員說明）我們的第一個問題來自史蒂芬斯的雅各布·約翰遜（Jacob Johnson）。現在你的台詞是——我們的第一個問題來自史蒂芬斯的雅各·約翰遜的台詞。

Apologies. Maybe first, just on the $5 million reduction in guidance. Can you just talk through how much of that is related to the inventory and how much of that is related to Europe. Can you hear me guys?

道歉。也許首先是指導意見減少了 500 萬美元。您能否簡單談談其中有多少與庫存有關以及有多少與歐洲有關。你們聽得到我說話嗎？

Yes, sorry about that. Yes, sorry. Just the $5 million change in guidance, can you just flesh that out in terms of how much of that's related to U.S. inventories? And then how much of that is related to Europe, et cetera?

是的，對此感到抱歉。是的，抱歉。僅是 500 萬美元的指導變化，您能否具體說明其中有多少與美國庫存相關？那麼其中有多少是與歐洲等相關呢？

Yes. Thanks. Vivek, do you want to handle that?

是的。謝謝。維韋克，你願意處理嗎？

Sure. I'd be happy to. The main component of that is related to the readjustment of inventories in the U.S. associated with the reduced shelf life. I'm not sure whether we break out specifically by Europe versus the U.S., but that certainly was the main headwind we faced in the first half of the year, which now that we've seen normalized ordering patterns, what leads to our confidence to realized growth in the back half of the year, but that's kind of where the majority of that comes from.

當然。我很樂意。其中主要部分與美國因保質期縮短而進行的庫存調整有關。我不確定我們是否會在歐洲與美國之間取得突破，但這肯定是我們今年上半年面臨的主要阻力，現在我們已經看到了正常化的訂購模式，這讓我們有信心今年下半年實現了增長，但這就是大部分成長的來源。

Okay. That's helpful. Thanks Vivek. And then, Kevin, just on the $10 million of cost savings you expect to realize. Can you kind of help us understand how much of that's maybe coming out of COGS versus SG&A, we think about modeling that?

好的。這很有幫助。謝謝維韋克。然後，凱文，您期望實現 1000 萬美元的成本節省。您能否幫助我們了解其中有多少可能來自 COGS 與 SG&A，我們考慮對其進行建模？

Yes .Firstly, let me -- I'll answer that directly, but I wanted to correct something in the prepared remarks. The FX impact that we realized was 80 basis points, 0.8% rather than 800. So I apologize for that. We had a typo. But to answer your question specifically, we don't expect that the savings is going to come from COGS. It's going to come from operating expenses. And it's going to come from both R&D and SG&A. So on an annualized basis, after we cease use of some of our real estate, we do expect that we'll see at least $10 million in annualized savings.

是的。首先，讓我——我會直接回答這個問題，但我想糾正準備好的發言中的一些內容。我們意識到對外匯的影響是 80 個基點，即 0.8%，而不是 800。所以我對此表示歉意。我們有一個錯字。但具體回答你的問題，我們預期節省的成本不會來自銷貨成本。它將來自營運費用。它將來自研發和銷售、一般管理費用。因此，按年計算，在我們停止使用部分房地產後，我們預計每年將節省至少 1000 萬美元。

Okay. Great. Thanks, Dave. I'll leave it there.

好的。偉大的。謝謝，戴夫。我會把它留在那裡。

Thank you. Please stand by for our next question. Our next question comes from the line of Matt Blackman of Stifel.

謝謝。請等待我們的下一個問題。我們的下一個問題來自 Stifel 的 Matt Blackman。

Can you hear me okay?

你聽得到我說話嗎？

Yes, we can hear you. Can you hear us?

是的，我們能聽到你的聲音。你可以聽見我們嗎？

I can hear you. Yes, just checking. I know. Maybe to start and Vivek, I just was hoping you could maybe expand a little bit more on your reply to that question. I think you commented about seeing a return to normalized ordering patterns, I think at the maybe the back half of the quarter, maybe early here in the third quarter. Could you just sort of expand on that a little bit and sort of, again, why that gives you confidence that the issues that you saw here in the second quarter are sort of largely behind you? And then I've got a couple of follow-ups.

我可以聽見你。是的，只是檢查一下。我知道。也許首先，Vivek，我只是希望你能對這個問題的回答進行更多的闡述。我想你評論說看到回歸正常化的訂購模式，我想可能是在本季後半段，也許是在第三季初。您能否稍微擴展一下這一點，為什麼這讓您相信您在第二季度看到的問題基本上已經過去了？然後我有一些後續行動。

Yes, sure. I'd be happy to and certainly welcome Obi and Kevin to vein as well. The thing that -- the single largest reason for confidence has to do with the fact that we saw no degradation of share. And so really the impact of the short shelf life was a function of just rebalancing inventories. And I think as you know, just given the nature of our business, our deployment organization, we work very closely with our blood center partners. We have good insight into their operations, how they produce product, how they distribute a product. And so as we come to appreciate that they sort of reached a normalized level of inventory where they're able to feel good about their ability to meet platelet demand and also manage inventory, we've seen that return to normal ordering patterns, which again gives us confidence in terms of our outlook for growth in the second half of the year. But the single largest driver of my confidence in all of this is we saw no reduction in share and pathogen reduction continues to be the standard of the care in terms of how platelet safety is maintained in the U.S.

是的，當然。我很高興並且當然歡迎奧比和凱文加入。信心的最大原因與我們看到份額沒有下降這一事實有關。因此，保質期短的影響實際上是重新平衡庫存的結果。我認為如您所知，鑑於我們的業務和部署組織的性質，我們與血液中心合作夥伴密切合作。我們對他們的營運、他們如何生產產品、他們如何分銷產品有深入的了解。因此，當我們意識到他們的庫存達到了正常水平，他們能夠對自己滿足血小板需求和管理庫存的能力感到滿意時，我們已經看到他們恢復了正常的訂購模式，這再次這讓我們對下半年的成長前景充滿信心。但我對這一切充滿信心的最大動力是，我們看到份額沒有減少，就如何維持美國血小板安全而言，減少病原體仍然是護理標準。

Okay. And then can I just follow up and ask in the first quarter, on the red cell -- sorry, Red Cross inventory drawdown. Just did that play out here in the second quarter as expected? And is that largely behind you? And then I do have one follow-up after that. I just want to make sure on the Red Cross, where we stand on that front.

好的。然後我可以在第一季跟進並詢問有關紅血球的問題——抱歉，紅十字會庫存減少。第二季的情況是否如預期發生？這很大程度上已經過去了嗎？之後我確實進行了一項後續行動。我只想確定紅十字會在這方面的立場。

Yes, sure, absolutely. So to answer the first part of the question, yes, we had talked about that. I think back in April, that played out largely as we anticipated. The Red Cross continues to be a very strong strategic partner. They've indicated that they're moving towards harmonizing their entire platelet franchise around pathogen reduction. They're nearly there at this point in time, and we're seeing continued strong partnership for them. So I think the way you described it is accurate.

是的，當然，絕對是。因此，為了回答問題的第一部分，是的，我們已經討論過這一點。我回想起四月的情況，情況基本上符合我們的預期。紅十字會仍然是非常強大的策略夥伴。他們表示，他們正在努力圍繞減少病原體來協調整個血小板業務。他們現在已經快要實現目標了，我們看到他們之間持續保持著強而有力的合作關係。所以我認為你描述的方式是準確的。

Okay. And then this is my last one, I appreciate you taking all my questions. But as we move past this, let's call it, inventory realignment period here in the first half of '23, how would you have us think about just in general, normalized growth trajectory for the business until we get red cell contribution, I guess, in Europe in 2025, U.S. in the 2027 time line. Just anything to help frame how the business should grow here over the next period as we're waiting for the expanded indications, expanded approvals as such.

好的。這是我的最後一個問題，感謝您回答我所有的問題。但是，當我們度過這個時期，我們稱之為 23 年上半年的庫存調整期時，您會讓我們如何考慮業務的一般性正常化增長軌跡，直到我們獲得紅血球貢獻，我想， 2025 年在歐洲，2027 年在美國。在我們等待擴大的適應症、擴大的批准之際，任何有助於框架業務在下一個時期應如何發展的事情都可以。

Yes, sure. Happy to. And again, maybe I'll ask Obi and Kevin to jump in to cover up to add any thoughts here when I finish in. Advance with red cells, if you think about growth opportunities kind of stepping back on a global basis, there continues to be significant markets where we're either just initiating introduction of platelets or that has yet to start. We've talked about in the past our joint venture partnership in China with ZBK.

是的，當然。高興。再說一次，也許我會在我結束時請奧比和凱文跳進來掩蓋，以在這裡添加任何想法。紅血球的進步，如果你考慮在全球範圍內退一步的增長機會，那麼繼續是我們剛剛開始引入血小板或尚未開始的重要市場。我們過去曾討論過我們與 ZBK 在中國的合資夥伴關係。

There are certainly major markets in Western Europe and Latin America that as of yet, are untapped, there's still headroom in the U.S. platelet market. So well over standard of care, we're sort of going into the post guidance compliance period. There are still opportunities for growth in the U.S. platelet market.

西歐和拉丁美洲肯定有一些主要市場尚未開發，美國血小板市場仍有發展空間。遠遠超出護理標準，我們即將進入指導後合規期。美國血小板市場仍有成長機會。

And then if I think about an independent driver that's been a significant area of focus, then we see real reasons for enthusiasm and momentum that's in the U.S. IFC franchise, where we fully staffed our hospital-facing sales team. We're finding access to hospitals to be increasingly -- something that's growing increasingly. We're getting a lot of clinical feedback, and we're onboarding really influential hospitals in terms of utilizing the IFC product. So those would be the areas in advance of red cells where I see us being able to deliver top line growth. And again, why we feel confident that we're in a position where we're seeing a normalization of ordering patterns and a return to growth for the overall franchise.

然後，如果我考慮一個重要的關注領域的獨立驅動程序，那麼我們就會看到美國國際金融公司特許經營權的熱情和動力的真正原因，我們為面向醫院的銷售團隊配備了充足的人員。我們發現去醫院的機會越來越多——這種情況還在增加。我們收到了大量的臨床回饋，我們正在幫助一些真正有影響力的醫院使用 IFC 產品。因此，我認為這些將是紅血球之前的領域，我們能夠實現營收成長。再說一次，為什麼我們有信心看到訂購模式正常化以及整體特許經營恢復成長。

Yes. Thanks, Vivek. I think you covered it. The one other thing I'd add is just in the Vivek's prepared comments, we talked about the relationship with OneBlood, our new production partner and what that unlocks with regard to a channel. And they have existing obviously, hospital contracts around blood components that they can insert IFC directly into, so we don't have to worry about hospital contracting in that context. And so we're really excited about the progress that they're making as well as progress across a lot of academic hospitals across the U.S.

是的。謝謝，維韋克。我認為你涵蓋了它。我要補充的另一件事是在 Vivek 準備好的評論中，我們討論了與我們的新製作合作夥伴 OneBlood 的關係，以及它對頻道的解鎖內容。顯然，他們已經與醫院簽訂了圍繞血液成分的合同，他們可以將 IFC 直接插入其中，因此我們不必擔心醫院在這種情況下簽訂合約。因此，我們對他們所取得的進展以及美國許多學術醫院所取得的進展感到非常興奮。

Appreciate it. I'll get back in queue.

欣賞它。我會回到隊列中。

Please standby for our last question. Our last question comes from the line of Joshua Jennings of TD Cowen.

請等待我們的最後一個問題。我們的最後一個問題來自 TD Cowen 的 Joshua Jennings。

I was hoping to just get an update on the build-out of the U.S. sales force, the hospitals facing reps, and I know it's still very early. But anything you can share just on the impacts of that build-out in 2Q, both in terms of drumming up IFC demand and adoption and also just the potential early impacts of driving hospital demand for INTERCEPT platelets and that trickling up, creeping up to the blood centers or their customers' increased demand?

我希望了解美國銷售隊伍建設、代表醫院的最新情況，我知道現在還為時過早。但您可以分享的任何內容都只是關於第二季度擴建的影響，無論是在刺激國際金融公司的需求和採用方面，還是在推動醫院對INTERCEPT 血小板的需求的潛在早期影響方面，並且這種影響會逐漸增加，逐漸蔓延到血液中心還是客戶增加的需求？

Yes. Thanks, Josh. As we have the U.S. commercial team out here a couple of weeks ago, I guess I'll turn it back over to Vivek since he was in the midst of all those meetings, but it was really a great discussion and interaction with the various hospital customers that they're engaged with. Vivek, do you want to give a little more context around that?

是的。謝謝，喬許。由於幾週前我們有美國商業團隊來到這裡，我想我會將其轉回給 Vivek，因為他參加了所有這些會議，但這確實是與各個醫院進行的一次很棒的討論和互動他們所接觸的客戶。 Vivek，您想提供更多相關背景資訊嗎？

Yes, sure. I'd be happy to. I guess kind of taking a step back, one of the things, Josh, is very encouraging was just the volume of compelling CVs and resumes that we received when we posted those roles. Selling IFC, as you know, is more of a classic physician preference sale. While there are multiple stakeholders in the decision-making process, one of the key starting points of strong clinical chance in who sees benefit in her/his practice in terms of being able to impact patients.

是的，當然。我很樂意。我想退一步說，喬希，非常令人鼓舞的一件事就是我們在發布這些職位時收到的大量引人注目的簡歷和履歷。如您所知，出售 IFC 更像是經典的醫生偏好銷售。雖然決策過程中有多個利益相關者，但強大的臨床機會的關鍵起點之一是誰在她/他的實踐中看到了能夠影響患者的好處。

And so we were able to get reps from a variety of different specialties to come in, who have relationships with CV surgery, trauma, high-risk OB. And so that was encouraging in and of itself. We're already seeing an impact in terms of really an order of magnitude step-up with respect to hospital visits engagements. And as we get clinicians on board, we're seeing a lot of peer-to-peer marketing, which is pretty meaningfully impactful.

因此，我們能夠聘請來自各個不同專業的代表，他們與心血管手術、創傷、高風險產科有關係。這本身就是令人鼓舞的。我們已經看到了醫院就診量確實增加了一個數量級的影響。當我們讓臨床醫生參與其中時，我們看到了很多點對點行銷，這是非常有意義的影響力。

As Obi indicated, we brought the fully hired sales team together in California about a month ago now, and we did cross-training on both IFC and platelets, and we certainly see opportunities when they're in hospitals to have discussions about platelets as well to further drive demand there. We're seeing a lot of our heavy platelet user hospitals being the ones who are raising their hands on IFC. So there are a lot of cross-pollination opportunities there, and we're trying to take full advantage of that.

正如 Obi 指出的那樣，大約一個月前，我們在加利福尼亞州召集了全部聘用的銷售團隊，我們對 IFC 和血小板進行了交叉培訓，我們當然看到了他們在醫院時也討論血小板的機會進一步推動那裡的需求。我們看到許多大量使用血小板的醫院都向國際金融公司舉手。因此，那裡有很多異花授粉的機會，我們正在努力充分利用這一點。

So it's early days still, as you pointed out, but we know that demand generation and clinical awareness falls upon us in terms of responsibility and the sales team is a huge asset in terms of being able to deliver against that.

因此，正如您所指出的，現在還處於早期階段，但我們知道，就責任而言，需求生成和臨床意識落在我們身上，而銷售團隊在能夠實現這一目標方面是一筆巨大的資產。

Great. And I just wanted to follow back for that. And I wanted to follow up on -- I know you're not giving out kind of hard metrics on the IFC launch, and this is a foundation building year. But maybe you could just help us think through the first half of the year. I think you're ahead of internal expectations for 2023? And then any update on any clinical studies or use case action that's going on. I think you called out an academic medical center in New York City that's running something and when those use case or clinical studies could be more impactful to the ramp of adoption of IFC in the United States.

偉大的。我只是想跟進這一點。我想跟進——我知道你們不會就 IFC 的推出提供硬性指標，而今年是基礎建設年。但也許你可以幫助我們思考今年上半年的情況。我認為您對 2023 年的預期超出了內部預期？然後是有關任何臨床研究或正在進行的用例行動的任何更新。我認為您提到了紐約市的一個學術醫療中心正在運行一些東西，當這些用例或臨床研究可能對 IFC 在美國的採用率產生更大影響時。

Thanks, Josh. So I think as the rollout this year has unfolded. We are seeing the type of interest from academic centers that we were expecting. And that seems to be ramping. There's real momentum behind peer-to-peer sort of interactions, and we're obviously trying to facilitate those. So I think that seeing major academic centers like UCSF and Ohio State and others really adopt the technology and then rolling out much more broadly within their institutions is really compelling.

謝謝，喬許。所以我認為隨著今年的推出已經展開。我們看到了學術中心所表現出的興趣，這正是我們所期待的。而且這種情況似乎正在加劇。點對點互動背後有著真正的動力，我們顯然正在努力促進這些互動。因此，我認為看到加州大學舊金山分校和俄亥俄州立大學等主要學術中心真正採用該技術，然後在其機構內更廣泛地推廣，這確實很引人注目。

And then the other thing I mentioned previously around OneBlood was just that channel combined with our existing sales team really opens up the market. It's not just the hospital contracts that exist, but also their internal teams. And as we expand those types of partnerships to even larger blood center institutions than OneBlood, that really gives us access across the entire country to major hospital, institutions. Larry, do you want to provide a little bit of color around the study that we're doing in New York and sort of what the initial observations are?

我之前提到的關於 OneBlood 的另一件事是，通路與我們現有的銷售團隊結合確實打開了市場。這不僅僅是存在醫院合同，還有他們的內部團隊。當我們將這些類型的合作關係擴展到比 OneBlood 更大的血液中心機構時，這確實使我們能夠接觸到全國各地的主要醫院和機構。拉里，你想為我們在紐約所做的研究提供一些資訊嗎？初步觀察結果是什麼？

Yes. We have a study which is running at New York Weill Cornell Medical Center. And what we're seeing is that IFC can be delivered from time of order to patients on average in 16 minutes. So we've dramatically changed the pattern of transfusion used for this product, and it's being well received in that setting, and we're rapidly accumulating the data that we'll have later this year or early next year.

是的。我們在紐約威爾康奈爾醫學中心正在進行一項研究。我們看到的是，從接到訂單起，IFC 平均可以在 16 分鐘內交付給患者。因此，我們極大地改變了該產品的輸血​​模式，並且它在該環境中受到了好評，並且我們正在迅速積累今年晚些時候或明年初將獲得的數據。

Thank you. This now concludes the question-and-answer portion of our call. I'd now like to pass the call back over to Obi Greenman, the CEO of Cerus for closing remarks.

謝謝。現在我們通話的問答部分就結束了。現在我想將電話轉回 Cerus 執行長 Obi Greenman，讓其致閉幕詞。

Well, thank you again for joining us today and for your interest in Cerus. We look forward to updating you on our continued progress through the rest of the year. Thanks a lot for joining us today.

好吧，再次感謝您今天加入我們以及您對 Cerus 的興趣。我們期待向您通報我們在今年剩餘時間內持續取得的進展。非常感謝您今天加入我們。

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

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。