Cytosorbents Corp (CTSO) 2023 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Afternoon, and welcome to the Cytosorbents fourth quarter and full year 2023 financial and operating results conference call. (Operator Instructions) Please be advised that the call will be recorded at the company's request. At this time, I'd like to turn the call over to our moderator, Eric Ribner. Please go ahead, Mr. Ribner.

    下午,歡迎參加 Cytosorbents 第四季和 2023 年全年財務和營運業績電話會議。(操作員說明)請注意,根據公司的要求,將對通話進行錄音。現在,我想將電話轉給我們的主持人 Eric Ribner。請繼續,里布納先生。

  • Eric Ribner - IR

    Eric Ribner - IR

  • Thank you and good afternoon. Welcome to Cytosorbents fourth quarter and full year 2023 financial and operating results conference call. Joining me today from the company are Dr. Phillip Chan, Chief Executive Officer; Vincent Capponi, President and Chief Operating Officer; Kathleen Bloch, Chief Financial Officer; Dr. Makis Deliargyris, Chief Medical Officer; Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of CytoSorbents in Europe; Christopher Cramer, Senior Vice President of Business Development; and Dr. Irina Kulinets, Senior Vice President of Regulatory Affairs.

    謝謝你,下午好。歡迎參加 Cytosorbents 第四季和 2023 年全年財務和營運業績電話會議。今天與我一起參加公司活動的是執行長 Phillip Chan 博士;文森‧卡波尼 (Vincent Capponi),總裁兼營運長;凱瑟琳‧布洛赫,財務長; Makis Deliargyris 博士,首席醫療官; Christian Steiner 博士,歐洲 CytoSorbents 銷售與行銷執行副總裁兼董事總經理; Christopher Cramer,業務開發資深副總裁;以及監管事務資深副總裁 Irina Kulinets 博士。

  • Before I turn it over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements, which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today.

    在將其轉交給陳博士之前,我想提醒聽眾,在電話會議期間,管理層準備好的言論可能包含前瞻性陳述,這些陳述存在風險和不確定性。管理層可能會針對您今天的問題做出更多前瞻性陳述。

  • Therefore, the company claims protection under the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today, and therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the SEC.

    因此,該公司要求 1995 年《私人證券訴訟改革法案》中包含的前瞻性聲明受到安全港的保護。實際結果可能與今天討論的結果有所不同,因此,我們建議您參閱該公司向 SEC 提交的文件中對這些風險和不確定性的更詳細討論。

  • Any projections as to the company's future performance represented by management include estimates as of today as of March 14, 2024 and we assume no obligation to update these projections in the future as market conditions change.

    管理階層對公司未來業績的任何預測均包括截至 2024 年 3 月 14 日的預測,我們不承擔未來隨著市場狀況變化而更新這些預測的義務。

  • During today's call, we will have an overview presentation covering the operating and financial highlights for the fourth quarter and full year 2023 by Dr. Chan and Miss. Bloch. Following that presentation, we will open up the line to your questions during the live Q&A session with the rest of the management team.

    在今天的電話會議中,我們將由陳博士和陳小姐進行概述介紹,涵蓋第四季度和 2023 年全年的營運和財務亮點。布洛赫。演講結束後,我們將在與管理團隊其他成員的現場問答環節中解答您的問題。

  • And now it is my pleasure to turn the call over to Dr. Chan. Phil --

    現在我很高興將電話轉給陳博士。菲爾--

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Thank you very much. Eric. Today, I'd like to talk a little bit about our recent operational highlights. First of all, we're pleased to say that as of the end of 2023, we had more than 228,000 cumulative CytoSorb treatments delivered. It was up 17% from the end of 2022. Our European Union CE Mark for CytoSorb was extended under the medical device directive MDD the earlier of either December 2028 or one we achieve EU medical device regulation certification, also known as MDR, which effort is currently ongoing.

    非常感謝。埃里克.今天,我想談談我們最近的營運亮點。首先,我們很高興地說,截至 2023 年底,我們已累計交付超過 228,000 例 CytoSorb 治療。較 2022 年底成長 17%。我們的 CytoSorb 歐盟 CE 標誌已根據醫療器材指令 MDD(最早於 2028 年 12 月)或我們獲得歐盟醫療器材法規認證(也稱為 MDR)的指令進行了延期,目前這項工作正在進行中。

  • We also entered into a new strategic partnership and temporary distribution agreement in India for CytoSorb with the publicly traded Indian pharmaceutical company, Eris Lifesciences following its definitive agreement with Biocon Biologics to acquire BioQuant Nephrology Branded Formulations unit. And with it [BioQuant] key leadership and field force of these businesses, including the personnel, we are commercializing CytoSorb in India.

    繼與 Biocon Biologics 達成收購 BioQuant Nephrology 品牌製劑部門的最終協議後,我們也與印度上市製藥公司 Eris Lifesciences 就 CytoSorb 在印度達成了新的策略合作夥伴關係和臨時分銷協議。憑藉這些業務的 [BioQuant] 關鍵領導力和現場力量(包括人員),我們正在印度將 CytoSorb 商業化。

  • Also of importance is our stand-alone chemo precision pump initiative. Our stand-alone pump initiative is expected to bring our next-generation blood purification capability to countries that do not have a strong dialysis infrastructure. We're expecting to launch our new purified pump later this year following the expiration of our distribution agreement with Nikkiso Europe GmbH for its pure just pump in September of last year, and this is a picture of the pump. This is how it will look. It's very easy to use. We've had excellent feedback from users who have been beta testing this unit, and we're very excited to be able to get this out into the market, hopefully in the very near future.

    同樣重要的是我們的獨立化學精密泵計劃。我們的獨立泵浦計劃預計將為那些沒有強大透析基礎設施的國家帶來下一代血液淨化能力。去年 9 月我們與 Nikkiso Europe GmbH 的純泵分銷協議到期後,我們預計將在今年稍後推出新的純泵,這是該泵的圖片。這就是它的外觀。它非常容易使用。我們從對該單位進行 Beta 測試的用戶那裡得到了很好的回饋,我們非常高興能夠將其推向市場,希望在不久的將來。

  • Moving on to the STAR-T trial, the pivotal STAR-T randomized controlled trial. We're pleased to say was selected for a breakout presentation at the American Association of Thoracic Surgery annual meeting being held April 27, through the 30, in Toronto Canada. The ATS Annual Meeting is one of the most prestigious cardiothoracic surgery conferences in the world and attracts users not only cardiac surgeons but for Fusionist and a whole host of other health care workers who are involved in cardiothoracic surgery to learn about new innovations and clinical data in the area, cardiothoracic surgery.

    接下來是 STAR-T 試驗,這是關鍵的 STAR-T 隨機對照試驗。我們很高興地宣布,我們被選中在 4 月 27 日至 30 日在加拿大多倫多舉行的美國胸腔外科協會年會上進行突破性演講。ATS 年會是世界上最負盛名的心胸外科會議之一,不僅吸引了心臟外科醫生的用戶,還吸引了 Fusionist 和眾多其他參與心胸外科的醫護人員來了解心胸外科的新創新和臨床數據。領域,心胸外科。

  • Following this presentation, we plan to have a subsequent Analyst and Investor Day and provide a review of the data with investors and analysts by an esteemed five router panel. This will not be the same day as the ATS meeting presentation, but it will likely be either later that week or the following week.

    在本次演講之後,我們計劃舉辦隨後的分析師和投資者日活動,並由受人尊敬的五位路由器小組與投資者和分析師一起審查數據。這不會與 ATS 會議演示在同一天進行,但可能會在那週晚些時候或下週舉行。

  • Based upon our additional analysis that we've done following our top line data announcement in December. We plan to submit now for regulatory approval of DrugSorb-ATR to US FDA and Health Canada in the second half of 2024, with the idea of reducing the severity of bleeding in patients undergoing isolated cabbage surgery on the blood center platform.

    根據我們在 12 月公佈頂線數據後所做的額外分析。我們計劃於 2024 年下半年向美國 FDA 和加拿大衛生部提交 DrugSorb-ATR 的監管批准,其想法是減少在血液中心平台上接受離體捲心菜手術的患者出血的嚴重程度。

  • Here you see is a tentative estimated STAR-T time line where the final data analysis is pending imminently. We expect to have the data presented at the late-breaking session at [AATS] in late April, data from the STAR registry, which is a real-world collection of data coming from Europe for using CytoSorb in the application to remove blood centers. Well, an analysis of that registry, the third analysis will be presented at the Euro PCR conference in Europe in May 2024. If everything goes well, we will be in a position to submit to FDA in the second half of this year.

    您可以在此處看到初步估計的 STAR-T 時間線,其中最終數據分析即將進行。我們預計將在 4 月下旬的 [AATS] 最新會議上公佈這些數據,這些數據來自 STAR 註冊中心,這是來自歐洲的真實世界數據集合,用於在移除血液中心的應用中使用 CytoSorb。好吧,對該註冊的分析,第三次分析將於 2024 年 5 月在歐洲舉行的歐洲 PCR 會議上公佈。如果一切順利的話,我們將能夠在今年下半年向 FDA 提交申請。

  • Based upon FDA time lines, 45 days after submission the FDA will give formal notice if appropriate, of acceptance. And from there, it's about an 8 to 10-month process based upon FDA published timelines to potential approval.

    根據 FDA 的時間表,提交後 45 天,FDA 將在適當的情況下發出正式接受通知。從那時起,根據 FDA 公佈的潛在批准時間表,大約需要 8 到 10 個月的流程。

  • In the meantime, we will also be preparing the Health Canada submission, and we'll hopefully be able to get that out before the end of this year, setting up a time line for the second half of 2025 to obtain potentially approval for FDA -- from FDA for DrugSorb-ATR and also approval from Health Canada as well. If things go well, we expect to begin commercialization shortly after receiving approval in the second half of 2025.

    同時,我們也將準備向加拿大衛生部提交的文件,希望能夠在今年年底前完成,並製定 2025 年下半年的時間表,以獲得 FDA 的潛在批准 - - DrugSorb-ATR 獲得FDA 的批准,並獲得加拿大衛生部的批准。如果一切順利,我們預計將在 2025 年下半年獲得批准後不久開始商業化。

  • We believe that focusing on our approval requests on isolated cabbage population will not significantly change our US and Canadian total addressable market opportunity. Given that patients on ticagrelor needing isolated cabbage represent the overwhelming majority facing this clinical need and on the next slide, you can see that the numbers haven't changed much from what has been in our investor presentation. It's about 65,000 patients on par with the meeting emergent or urgent cabbage surgery annually. And about $5,000 of device represents about a $325 million initial US and Canada total addressable market.

    我們相信,專注於對孤立捲心菜群體的批准請求不會顯著改變我們在美國和加拿大的整體潛在市場機會。鑑於需要單獨捲心菜的替格瑞洛患者佔絕大多數面臨這種臨床需求,在下一張投影片中,您可以看到這些數字與我們投資者簡報中的數字沒有太大變化。每年約有 65,000 名患者接受緊急或緊急的高麗菜手術。價值約 5,000 美元的設備代表美國和加拿大初始潛在市場總額約為 3.25 億美元。

  • We expect that the growth and market share will grow, given that drug survey tier would make front with the only reversible P2Y12 platelet inhibitor on the market and also because [Proventic] goes off patent in 2024 this year, likely leading to a drop in prices, which has been the major advantage of Plavix, which is generic in the United States market. Once that price differential goes away, we expect the superior drug for [Berlin] to gain market share, helping to potentially expand the total addressable market in the United States and Canada by twofold.

    我們預計成長和市佔率將會成長,因為藥物調查層將領先市場上唯一可逆的 P2Y12 血小板抑制劑,而且 [Proventic] 專利將於今年 2024 年到期,可能導致價格下降,這一直是波立維的主要優勢,波立維在美國市場上是仿製藥。一旦價格差異消失,我們預計[柏林]的優質藥物將獲得市場份額,有助於將美國和加拿大的潛在市場總量擴大兩倍。

  • Now turning to our sales update. The press release, I think goes over the sales highlights for 2023. However, I wanted to point out a few things. One is that core CytoSorb sales grew 10% year-over-year. And although that number is relatively modest, I think it masks some excellent performance that we have been seeing in our certain of our sales divisions.

    現在轉向我們的銷售更新。我認為新聞稿概述了 2023 年的銷售亮點。不過,我想指出一些事情。其中之一是核心 CytoSorb 銷售額較去年同期成長 10%。儘管這個數字相對較小,但我認為它掩蓋了我們在某些​​銷售部門所看到的一些出色表現。

  • As you recall, we have a hybrid sales model where we sell direct in Germany. We sell direct internationally and 14 other countries with our own direct sales force. And we sell in 60 other countries through our distributor and partner division.

    您還記得嗎,我們採用混合銷售模式,在德國直接銷售。我們擁有自己的直銷隊伍,在國際上和其他 14 個國家進行直接銷售。我們透過經銷商和合作夥伴部門在其他 60 個國家/地區進行銷售。

  • What we saw in 2023 was strong performance from our international direct division, again, accounting for 14 countries where they saw 27% sales growth, $6 million or roughly 19% of product sales for the year. This is important as we look to continue to diversify our revenue base to really account for the 75 countries around the world where we sell CytoSorb today. Distributor partner sales in the first three quarters of 2024 actually grew 18% versus the same period in 2022, not including US distributor sales.

    我們在 2023 年看到的是我們的國際直接部門的強勁表現,在 14 個國家的銷售額增長了 27%,達到 600 萬美元,約佔當年產品銷售額的 19%。這一點很重要,因為我們希望繼續實現收入基礎多元化,以真正涵蓋我們目前銷售 CytoSorb 的全球 75 個國家。2024 年前三個季度的經銷商合作夥伴銷售額實際上比 2022 年同期成長了 18%,其中不包括美國經銷商的銷售額。

  • However, because of the change that we made and the decision to let the Nikkiso’s PureADJUST hemoperfusion distribution agreement, hemoperfusion pump fisher fusion agreement expire in favor of bringing our own pump to market. This impacted ordering from distributors and wound up with a delay in distributor orders slipping into 2024.

    然而,由於我們做出的改變以及決定讓 Nikkiso 的 PureADJUST 血液灌流分銷協議、血液灌流泵 Fisher fusion 協議到期,有利於將我們自己的泵推向市場。這影響了分銷商的訂單,最終導致分銷商訂單推遲到 2024 年。

  • Because of this, overall sales growth for the year was 9%, including US distributor sales for 39% of product sales for the year. And finally, direct sales in Germany grew 3%, although the market significantly improved in 2023, hospitals are still feeling the weight of the aftermath of COVID-19 in terms of staffing shortages, fewer ICU beds, fewer ICU patients, fewer high revenue generating procedures moving through the intensive care unit, but also a range of additional costs driven by inflation, including energy and staffing for us as well.

    因此,全年整體銷售額成長了 9%,其中美國經銷商銷售額佔全年產品銷售額的 39%。最後,德國的直銷成長了 3%,儘管市場在 2023 年顯著改善,但醫院仍感受到了 COVID-19 後果的影響,包括人員短缺、ICU 床位減少、ICU 患者減少、高收入來源減少重症監護病房的手術費用,還有通貨膨脹帶來的一系列額外費用,包括我們的能源和人員。

  • However, we are seeing a significantly improved outlook for 2024, and we hope that this will begin a recovery in Germany. Germany represented 42% of our product sales last year. That said, we are currently tracking a proposal for health care reform maternity hospital system.

    然而,我們看到 2024 年的前景顯著改善,我們希望這將在德國開始復甦。去年,德國占我們產品銷售額的 42%。也就是說,我們目前正在追蹤一項醫療保健改革婦產醫院制度的提案。

  • In July 2023, Germany's Federal and state governments issued a consensus white paper that could result in new laws that change how hospitals are funded. Government payments to hospitals would deemphasize the GRG also known as a diagnosis related group lump sum payment system that incentivizes revenue generation through more patients treated and procedures performed.

    2023 年 7 月,德國聯邦和州政府發布了一份共識白皮書,可能會制定新的法律來改變醫院的資助方式。政府向醫院付款將削弱GRG(也稱為診斷相關團體一次性支付系統)的重要性,該系統透過治療更多患者和執行更多手術來激勵創造收入。

  • And it's that emphasize based payments focused on quality measures and appropriate patient care. This is expected to favor a shift of routine operations and procedures to outpatient centers. A consolidation of smaller hospitals into larger ones, and importantly, an increased focus of remaining hospitals on sicker patients more complex operations such as, cardiothoracic surgery and organ transplant. And on therapies that help reduce the severity of illness and help patients recover faster.

    它強調基於品質措施和適當的患者護理的支付。預計這將有利於將常規手術和程序轉移到門診中心。將較小的醫院合併為較大的醫院,重要的是,剩餘醫院更加關注病情較重的患者和更複雜的手術,例如心胸外科和器官移植。以及有助於減輕疾病嚴重程度並幫助患者更快康復的療法。

  • Given that the goal of our therapies is to improve clinical outcomes while reducing the cost of critical care and cardiac surgery by controlling deadly inflammation and other life-threatening conditions. While reducing the need for expensive life-support measures that keep patients in the hospital. We believe such reform may favor our business in the longer term. Hospital administrators expect such change will take careful planning and time potentially even years to implement, and we look to track these developments with interest.

    鑑於我們治療的目標是改善臨床結果,同時透過控制致命發炎和其他危及生命的病症來降低重症監護和心臟手術的成本。同時減少了對昂貴的生命維持措施的需求,使患者留在醫院。我們相信,從長遠來看,此類改革可能有利於我們的業務。醫院管理人員預計,此類變革將需要仔細的規劃和時間,甚至可能需要數年的時間才能實施,我們希望饒有興趣地追蹤這些進展。

  • Now many of you have seen this slide before we talk about the extensive support of our technology by the US government to the tune of about $50 million in grants and contracts and other nondilutive funding. And on the left-hand side, you see here three products that are actually being commercialized today. We typically focus on CytoSorb, and we don't really talk too much about ECOS-300CY or event rescue. But today I wanted to trying to do that.

    現在,在我們談論美國政府對我們的技術提供約 5000 萬美元的贈款、合約以及其他非稀釋性資金的廣泛支持之前,你們中的許多人已經看過這張幻燈片。在左側,您可以看到三種目前已實際商業化的產品。我們通常關注 CytoSorb,並且不會談論太多 ECOS-300CY 或事件救援。但今天我想嘗試這樣做。

  • In addition on the right-hand side, our products under current development and one of the products HemoDefend - BGA for the development of universal plasma is a program which we've received $17 million for DOD grant funding to bring this to market. And I thought I'd spend a slide on each of these products, just to give you a flavor of what we're doing today.

    此外,在右側​​,我們正在開發的產品以及用於開發通用血漿的產品之一 HemoDefend - BGA 是一項計劃,我們已收到 1700 萬美元的國防部撥款資金,以將其推向市場。我想我應該用一張幻燈片來介紹這些產品,只是為了讓您了解我們今天所做的事情。

  • To ECOS-300CY is approved in the European Union for ex vivo organ perfusion and for solid organ transplant. Solid organ transplant is the main treatment option in advanced organ failure, but is limited by the availability of suitable and healthy organs. ex vivo organ perfusion or otherwise known as EVOP, with temperature controlled oxygenated nutrient rich fluid or blood is being increasingly used as an alternative to transporting to [organ on ice] to improved functioning of transplanted organs that the salvage substandard ones that would otherwise be discarded.

    ECOS-300CY 已在歐盟獲得批准用於離體器官灌注和實體器官移植。實體器官移植是晚期器官衰竭的主要治療選擇,但受到合適和健康器官的可用性的限制。離體器官灌注或也稱為EVOP,使用溫度控制的含氧營養豐富的液體或血液,越來越多地用作運輸到[冰上器官]的替代方案,以改善移植器官的功能,而不是搶救不合格的器官,否則這些器官將被丟棄。

  • However, it does not directly control inflammation with all -- within the organ. That is often the core to the organ dysfunction that is seen [every] operatively. ECOS-300CY specifically EU approved to reduce inflammatory mediators during EVLP. And on the lower left hand side here, you can see an ex vivo organ perfusion machine by, call it the per life system by one of our partners [Aferetica]. We've been one of the pioneers in this space and we work with them and provide a private label cartridge called PerSorb that plugs right into their system.

    然而,它並不能直接控制器官內的所有發炎。這通常是[每次]手術中看到的器官功能障礙的核心。ECOS-300CY 已獲得歐盟特別批准,可在 EVLP 期間減少發炎介質。在左下角,您可以看到一台離體器官灌注機,我們的合作夥伴之一將其稱為“每生命系統”[阿費雷蒂卡]。我們是這個領域的先驅之一,我們與他們合作,提供一種名為 PerSorb 的自有品牌墨盒,可以直接插入他們的系統。

  • And the goals and cited benefits of ECOS-300CY and early data are that it reduces inflammatory mediators. It helps to recondition poorly functioning organs that would normally be discarded, increasing the donor pool of organs and in early data in both pigs as well as in early human studies, has been shown to reduce rates of primary graft dysfunction, particularly in lung transplants helping to improve clinical outcomes.

    ECOS-300CY 的目標和所提到的好處以及早期數據是它可以減少發炎介質。它有助於修復通常會被丟棄的功能不良的器官,增加器官供體庫,並且在豬和早期人類研究的早期數據中,它已被證明可以降低原發性移植物功能障礙的發生率,特別是在肺移植中幫助以改善臨床結果。

  • On the next slide is that rescue, which is essentially CytoSorb for companion animals. And the COVID pandemic has driven companion animal ownership now with 45% of US households owning a dog in 26%, owning a cat according to the American Veterinary Medical Society. Companion animals approach to a wide variety of medical emergencies ranging from drug intoxication, heat stroke infection such as leftist versus sepsis and septic shock, trauma and others.

    下一張投影片是救援,本質上是針對伴侶動物的 CytoSorb。根據美國獸醫學會的數據,新冠疫情大流行推動了伴侶動物的擁有,目前 45% 的美國家庭擁有一隻狗,26% 的家庭擁有一隻貓。伴侶動物會處理各種醫療緊急狀況,包括藥物中毒、中暑的感染(如左敗血症和敗血症和敗血性休克)、創傷等。

  • That rescue brings the power of CytoSorb to veterinary medicine with three sizes of cartridges intended to treat the full size range of companion animals that you can see here. And in 2023, we had eliminated but successful launch of that rescue to a number of regional veterinary centers and a 2024, will be due our integrated all-in-one solution that includes the hemoperfusion pump for beds.

    這次救援將 CytoSorb 的力量帶入了獸醫領域,其三種尺寸的藥筒旨在治療您可以在此處看到的全尺寸範圍的伴侶動物。2023 年,我們取消了對多個地區獸醫中心的救援,但成功開展了這項救援工作;到 2024 年,我們將推出包括床位血液灌流泵在內的一體化一體化解決方案。

  • And last but not least. HemoDefend-BGA, which holds the promise of universal plasma HemoDefend-BGA was developed to create universal plasma, which is Plaza that does not need blood typing. It can be given off the shelf to anyone in need regardless of blood type by removing anti-A and anti-B antibodies that meet plasma blood type specific.

    最後但並非最不重要。HemoDefend-BGA,承載通用血漿的承諾 HemoDefend-BGA 的開發目的是創造通用血漿,即不需要血型的廣場。通過去除符合血漿血型特異性的抗 A 和抗 B 抗體,可以將現成的產品提供給任何有需要的人,無論血型如何。

  • And what you can see here on the right hand side is the current status of plasma logistics today where blood banks have to maintain pools of stores of Type A, Type B, Type AB and Type O plasma. But universal plasma, which simplify those logistics because then a simple unit called universal plasma that could be given off the shelf to a patient regardless of their blood type.

    您在右側可以看到的是當今血漿物流的現狀,血庫必須維護 A 型、B 型、AB 型和 O 型血漿的儲存庫。但是通用血漿,它簡化了這些物流,因為那時有一個稱為通用血漿的簡單單元,可以將現成的血漿提供給患者,無論其血型如何。

  • Many applications of life-saving plasma include trauma resuscitation, treatment of critically ill patients and component purification, such as the isolation of clotting factors for hemophilia; for example, albumin for critical illness and IVIG for autoimmune disease treatment and infectious disease. In the United States alone, more than 10,000 units of fresh frozen plasma are administered daily for $3.6 million units per year.

    救生血漿的許多應用包括創傷復甦、重症病人的治療和成分純化,例如分離血友病的凝血因子;例如用於重症疾病的白蛋白和用於治療自體免疫疾病和傳染病的IVIG。光是在美國,每天就需要注射 10,000 多個單位的新鮮冷凍血漿,每年花費 360 萬美元。

  • And again, with more than $17 million in funding from the US Department of Defense, CytoSorb has successfully developed a demonstrated a prototype HemoDefend-BGA absorber that removes anti-A and anti-B antibody from human plasma with the goal of having our off-the-shelf one-size fits all blood type independent universal plasma provided that we can collaborate with a freeze-dried plasma provider to have that universal freeze-dried plasma in every ambulance and emergency room around the world. This is a big opportunity and we have now met recently with FDA and preliminary discussions with the goal of advancing HemoDefend-BGA to human clinical trials and commercialization.

    再次,借助美國國防部超過 1700 萬美元的資助,CytoSorb 成功開發了一款經過驗證的 HemoDefend-BGA 吸收劑原型,該吸收劑可從人類血漿中去除抗 A 和抗 B 抗體,目的是讓我們的貨架上的一種尺寸適合所有與血型無關的通用血漿,前提是我們可以與冷凍乾燥血漿供應商合作,在世界各地的每輛救護車和急診室中提供通用冷凍乾燥血漿。這是一個巨大的機會,我們最近與 FDA 進行了會面並進行了初步討論,目標是將 HemoDefend-BGA 推進人體臨床試驗和商業化。

  • So with that, let me turn it over to Kathy to go back and cover financial highlights for 2023. Kathy?

    因此,讓我將其交給 Kathy,讓我回顧一下 2023 年的財務亮點。凱西?

  • Kathleen Bloch - Chief Financial Officer

    Kathleen Bloch - Chief Financial Officer

  • Thank you, Phil, and hello to everyone on the call. Today, I will discuss our full year and fourth quarter 2023 financial results, including revenue gross margins. I will also be providing an update on our working capital and cash runway.

    謝謝你,菲爾,並向通話中的每個人問好。今天,我將討論我們 2023 年全年和第四季度的財務業績,包括收入毛利率。我還將提供有關我們的營運資金和現金跑道的最新資訊。

  • Next slide, please. Total 2023 revenue which includes both product sales and grant revenue was approximately $36.3 million as compared to $34.7 million in 2022, which is an increase of approximately $1.6 million or 5%. CytoSorb product sales were $31 million in 2023 compared to $28.6 million in 2022, which is an increase of approximately $2.4 million or 9%.

    請下一張投影片。包括產品銷售和贈款收入在內的 2023 年總收入約為 3,630 萬美元,而 2022 年為 3,470 萬美元,增加了約 160 萬美元或 5%。2023 年 CytoSorb 產品銷售額為 3,100 萬美元,而 2022 年為 2,860 萬美元,增加了約 240 萬美元或 9%。

  • There was an increase in the average exchange rate of the euro to the US dollar and this favorably impacted 2023 CytoSorb product sales by approximately $780,000. Other non-CytoSorb product revenue was $70,000 for 2023 compared to $787,000 for 2022 due to the discontinuation of orders from a customer who no longer required a specialized polymer.

    歐元兌美元平均匯率上升,這對 2023 年 CytoSorb 產品銷售額產生了約 78 萬美元的有利影響。由於不再需要專用聚合物的客戶中止訂單,2023 年其他非 CytoSorb 產品收入為 70,000 美元,而 2022 年為 787,000 美元。

  • Our product gross margin was 72% in 2023, up from 70% in 2022. And the company expects that gross margins will continue to improve into 2024 as we realize economies of scale at our new manufacturing facility. And finally, 2023 grant revenue was $5.3 million, which is approximately the same as 2022 grant revenue.

    2023年我們的產品毛利率為72%,高於2022年的70%。該公司預計,隨著我們新製造工廠實現規模經濟,毛利率將在 2024 年繼續提高。最後,2023 年的撥款收入為 530 萬美元,與 2022 年的撥款收入大致相同。

  • Next slide, please. This next slide, bar graphs on which the blue bars represent our annual product sales for each year of 2017 to 2023. And we know that 2020 and 2021, product sales were very favorably impacted because CytoSorb was used to treat COVID-19 patients. And of course, this usage ceased following the containment of the pandemic in subsequent years.

    請下一張投影片。下一張投影片是長條圖,其中藍色長條代表我們 2017 年至 2023 年每年的年度產品銷售額。我們知道,由於 CytoSorb 用於治療 COVID-19 患者,2020 年和 2021 年產品銷售受到了非常有利的影響。當然,隨著隨後幾年大流行的遏制,這種用法就停止了。

  • Taking a look though, at the orange trend line Arrow, which tracks along the non-COVID revenue years, we see that 2022 and 2023 continues to show positive year-over-year growth in product sales.

    不過,從追蹤非新冠疫情收入年份的橘色趨勢線箭頭來看,我們看到 2022 年和 2023 年產品銷售持續呈現年比正成長。

  • The post COVID market has been challenging, particularly in Germany, for reasons already articulated by Phil in his comments. However, while gradual, we are seeing improvements in the marketplace, which we expect will bring more growth to our product sales for 2024 and into the future.

    由於菲爾在評論中已經闡明的原因,新冠疫情後的市場一直充滿挑戰,尤其是在德國。然而,儘管市場正在逐步改善,但我們預計這將為 2024 年及未來的產品銷售帶來更多成長。

  • I also wanted to just comment on the green line which tracks our year-over-year gross margins, where we experienced a slight decline in 2022 when we began manufacturing at our new facility. And this was a result of manufacturing inefficiencies; for example, we had to do test runs as we brought the new facility into full operation. And again, we do expect to see improvements in product gross margins in 2024.

    我還想評論一下追蹤我們同比毛利率的綠線,2022 年我們在新工廠開始生產時,毛利率略有下降。這是製造效率低下的結果;例如,當新設施全面投入運作時,我們必須進行試運轉。同樣,我們確實預期 2024 年產品毛利率將有所改善。

  • Next slide, please. Now I'd just like to briefly review our fourth quarter 2023 results. Total revenue for the fourth quarter of 2023, which includes both product sales and grant revenue decreased 8% to approximately $8.7 million compared to approximately $9.4 million in the fourth quarter of 2023 sales.

    請下一張投影片。現在我想簡要回顧一下我們 2023 年第四季的業績。2023 年第四季的總收入(包括產品銷售和補助收入)下降 8%,至約 870 萬美元,而 2023 年第四季的銷售額約為 940 萬美元。

  • CytoSorb product sales were $7.3 million in the fourth quarter of 2023 compared to $7.4 million in the fourth quarter of 2022, a decrease of 1% the increase in the average exchange rate of the euro to the US dollar favorably impacted Q4 2023 CytoSorb product sales by approximately $369,000. Other product revenue was $14,000 in 2023 compared to $246,000 in 2022. As we mentioned due to the discontinuation of orders from customers who require a specialized polymer and grant revenue in the fourth quarter of 2023 was $1.3 million compared to $1.7 million (sic - see press release, $1.5 million in 2022) in the fourth quarter of 2022.

    2023 年第四季 CytoSorb 產品銷售額為 730 萬美元,而 2022 年第四季為 740 萬美元,下降了 1% 歐元兌美元平均匯率的上漲對 2023 年第四季 CytoSorb 產品銷售額產生了有利影響約369,000美元。2023 年其他產品收入為 14,000 美元,而 2022 年為 246,000 美元。正如我們所提到的,由於需要特殊聚合物的客戶停止訂單,2023 年第四季的撥款收入為130 萬美元,而2022 年第四季的收入為170 萬美元(原文如此- 參見新聞稿,2022年為150 萬美元) 。

  • Next slide, please. As of December 31, 2023, we have $15.6 million in cash, which includes $1.5 million of restricted cash. This amount includes net proceeds of $9.8 million from our equity raise in December 2023 and approximately $4.5 million raised in 2023 utilizing our ATM facility. Conservation of cash is a corporate priority. We have adjusted our budget and we've taken measures to reduce our quarterly cash burn in 2024.

    請下一張投影片。截至 2023 年 12 月 31 日,我們擁有 1,560 萬美元現金,其中包括 150 萬美元限制性現金。該金額包括 2023 年 12 月股權融資的 980 萬美元淨收益以及 2023 年利用 ATM 設施籌集的約 450 萬美元。節約現金是公司的首要任務。我們調整了預算,並採取措施減少 2024 年的季度現金消耗。

  • We have also instituted and continue to maintain tight controls over spending, and these actions are expected to preserve our cash runway. We know that we will need to raise capital to support our ongoing operations in the future. And the company is actively pursuing other sources of capital, including less are nondilutive debt financing, royalty financing, strategic or direct investments, equity financing and or combinations thereof.

    我們也建立並繼續保持對支出的嚴格控制,這些行動預計將保持我們的現金跑道。我們知道我們需要籌集資金來支持我們未來的持續營運。該公司正在積極尋求其他資本來源,包括非稀釋性債務融資、特許權使用費融資、策略或直接投資、股權融資或其組合。

  • That concludes my remarks for today. At this time, I'm going to turn the call back over to Phil. Phil?

    我今天的發言到此結束。這次,我要把電話轉回給菲爾。菲爾?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Thank you, Kathy. So in summary, today, CytoSorb drives our growth. CytoSorb forms the company's foundation is EU approved and sold around the world has generated more than $200 million in sales since launch is a high-margin razor blade business model with historical 80% blended product gross margins that has strong validation by customers, partners and government agencies. We believe we can return to and potentially even exceed our historic compound annual growth rate of approximately 25%.

    謝謝你,凱西。總而言之,今天,CytoSorb 推動了我們的成長。CytoSorb 為公司奠定了基礎,獲得歐盟批准並在世界各地銷售,自推出以來已產生超過2 億美元的銷售額,是一種高利潤剃須刀片商業模式,混合產品毛利率歷史高達80%,得到了客戶、合作夥伴和政府的大力認可機構。我們相信,我們能夠恢復甚至有可能超過約 25% 的歷史複合年增長率。

  • We have previously discussed a number of macro trends in healthcare that favor our therapies such as the aging population that is prone to critical illness. The use of blood thinners by millions of people worldwide to reduce the risk of heart attack and stroke and the epidemic of chronic liver disease that afflicts one in every five people globally.

    我們之前討論過一些有利於我們的療法的醫療保健宏觀趨勢,例如容易患危重疾病的人口老化。全球數百萬人使用血液稀釋劑來降低心臟病發作和中風的風險,以及全球五分之一的人患有慢性肝病的風險。

  • Meanwhile, we have also discussed our numerous growth initiatives like our stand-alone pump initiative with the pending launch of our own purified machine, the impact that supportive data from STAR-T may have on the blood center opportunity worldwide.

    同時,我們也討論了我們的眾多成長計劃,例如我們的獨立泵浦計劃以及即將推出的我們自己的純化機器,以及 STAR-T 的支援數據可能對全球血液中心機會產生的影響。

  • Our global marketing agreement with for Fresenius Medical Care for CytoSorb is the featured solution for cytokine, bilirubin, and myoglobin removal on its critical care platforms worldwide. Our new EU trademark of expanding the dimension of blood purification that highlights the up to 40% -- 50% of patients in the ICU where our therapies could be beneficial. And the relatively new applications with exciting recently published clinical data.

    我們與 Fresenius Medical Care 就 CytoSorb 達成的全球行銷協議是其全球重症監護平台上去除細胞激素、膽紅素和肌紅蛋白的特色解決方案。我們擴大血液淨化範圍的新歐盟商標強調了我們的療法可能對 ICU 中高達 40% 至 50% 的患者有益。以及相對較新的應用程式以及最近發布的令人興奮的臨床數據。

  • Because of that, we believe that CytoSorb, which is designed to address the $20 billion to $30 billion worldwide total addressable market of major unmet medical needs in critical care, cardiac surgery, as well as liver and kidney disease gives us a massive potential growth engine going forward. We believe the skill set to service the potential upside of a biotechnology company with a lower risk profile of a high margin medical device company with sale.

    正因為如此,我們相信 CytoSorb 旨在滿足全球 200 億至 300 億美元的潛在市場,其中包括重症監護、心臟手術以及肝腎疾病等主要未滿足的醫療需求,為我們提供了巨大的潛在增長引擎向前走。我們相信,這些技能可以為生技公司的潛在優勢提供服務,而高利潤醫療器材公司的銷售風險則較低。

  • But soon to start to be successful in drugs or ATR achieved US FDA and Health Canada regulatory approval, we intend to commercialize drugs our ATR in both United States and Canada, a potential second engine of growth for working in tandem with CytoSorb to drive sales and ultimately profitability. At this stage, we believe our company represents an exceptional value proposition.

    但很快就開始在藥物或ATR 領域取得成功,並獲得美國FDA 和加拿大衛生部監管部門的批准,我們打算將我們的ATR 藥物在美國和加拿大商業化,這是與CytoSorb 合作推動銷售和發展的潛在第二成長引擎。最終實現盈利。在現階段,我們相信我們的公司代表著卓越的價值主張。

  • With that operator, that ends our formal comments. Please open up the lines for questions.

    有了這個運算符,我們的正式評論就結束了。請打開提問線路。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Yuan Zhi, B. Riley Financial Inc.

    袁志 B. 萊利金融公司

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Thank you for taking our questions. And congrats on the AATS [breakout presentation] (inaudible). Just want to understand the timing of data release. So the conference will be in late April to you anticipate some abstract release before that? Thank you.

    感謝您接受我們的提問。恭喜 AATS [突破性示範](聽不清楚)。只是想了解數據發布的時間。那麼會議將於四月下旬舉行,您預計在此之前會發布一些摘要嗎?謝謝。

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Sure. Thanks, Yuan. Mike, do you want to take that?

    當然。謝謝,袁。麥克,你想要那個嗎?

  • Efthymios Deliargyris - Chief Medical Officer

    Efthymios Deliargyris - Chief Medical Officer

  • Sure. Thank you for the question. The data is part of a breakout session of clinical trials at the conference and the acceptance goes together with the agreement of an embargo of release of that information ahead of the conference. So the data will be released live during the AATS conference in Toronto. Not to have that.

    當然。感謝你的提問。這些數據是會議上臨床試驗分組會議的一部分,接受的同時也同意在會議之前禁止發布該資訊。因此,該數據將在多倫多 AATS 會議期間即時發布。沒有那個。

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Got it. And then, Phil, on the FDA device application. Now with this STAR-T trial result, do you intend to submit [Taiwan] 1K application or the premarket authorization platform to track if there's a change in standard?

    知道了。然後,菲爾,關於 FDA 設備申請。現在有了這個STAR-T試驗結果,您是否打算提交[台灣]1K申請或上市前授權平台來追蹤標準是否有變化?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Currently we have not disclosed what the regulatory strategy will be, but suffice it to say that we are currently working on that, but at the appropriate time closer to a submission, we'll make that publicly known.

    目前我們還沒有透露監管策略是什麼,但足以說明我們目前正在研究這一點,但在接近提交的適當時間,我們將公開這一點。

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Got it. And maybe one last question from me. Just want to hear about this impact of this sales channel change. I'm curious how long will this impact and the should we see for recovery from this channel change in first half or second half this year?

    知道了。也許還有我的最後一個問題。只是想聽聽銷售通路變化的影響。我很好奇這種影響會持續多久,以及我們是否應該在今年上半年或下半年看到頻道的復甦?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • When you're talking about the channel change, are you talking about the relative distribution of sales from our three divisions?

    當您談論通路變化時,您是在談論我們三個部門的銷售相對分佈嗎?

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Yes.

    是的。

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Yeah. Surprisingly, as it turns out that the percentage contribution to product sales has remained relatively constant. But what we have seen is that distributor sales have been growing in importance as that channel has gotten stronger and as those markets are being developed worldwide.

    是的。令人驚訝的是,事實證明,對產品銷售的貢獻百分比保持相對穩定。但我們看到的是,隨著通路的日益強大以及這些市場在全球範圍內的發展,經銷商銷售的重要性越來越大。

  • So historically, Germany sales had been 50% of our sales base currently as of last year, 42%. And distributor sales, which had been historically 30% are now 40%. And so we believe that if everything goes to plan that those percentages should remain roughly the same. But it is predicated on Germany, obviously recovering faster than we've seen it historically. But the good part is that we do see a change in the German market compared to a year ago. And maybe, Christian, you'd like to comment maybe on Germany, what you're seeing there?

    從歷史上看,德國銷售額占我們銷售額的 50%,截至去年為 42%。經銷商銷售額從歷史上的 30% 上升到了 40%。因此,我們相信,如果一切按計劃進行,這些百分比應該保持大致相同。但這是以德國為基礎的,德國的復甦速度顯然比我們歷史上看到的還要快。但好的方面是,與一年前相比,我們確實看到了德國市場的變化。也許,克里斯蒂安,您想對德國發表評論,您在那裡看到了什麼?

  • Christian Steiner - EVP of Sales and Marketing

    Christian Steiner - EVP of Sales and Marketing

  • Yes. Thank you, Phil. Thank you, Yuan for the question. So just to add some context to what Phil said, some -- Yes, we see obviously a stabilization of the business in the more mature markets. So the more mature markets, I specifically say the central European markets like Germany, Austria and Switzerland. But on the other hand, we see a much more pronounced path towards growth in the other direct markets and our distributor markets.

    是的。謝謝你,菲爾。謝謝袁老師的提問。因此,只是為菲爾所說的添加一些背景,一些 - 是的,我們顯然看到更成熟市場的業務趨於穩定。所以比較成熟的市場,我特意說的是德國、奧地利、瑞士等中歐市場。但另一方面,我們看到其他直接市場和經銷商市場的成長之路更加明顯。

  • And this is some this is very much dependent on the state of development, and I very much expect that these direct markets outside Germany, Austria, Switzerland and the distributor markets coming to a similar growth phase as we have seen in Germany and two, three years ago.

    這在很大程度上取決於發展狀況,我非常希望德國、奧地利、瑞士以外的這些直接市場和分銷商市場能夠像我們在德國和兩三個國家看到的那樣進入類似的增長階段幾年前。

  • So that was one point and the other point is coming back to Germany that, as I said, we have seen the stabilization of the markets, but still there's a lot of post pandemic, but also structural problems in the health care system. We are at the momentum on the path to overcome this.

    這是一點,另一點是回到德國,正如我所說,我們已經看到市場的穩定,但仍然存在許多大流行後的問題,而且醫療保健系統也存在結構性問題。我們正處於克服這一問題的動力之中。

  • And on top, we are having initiated or scheduled a number of initiatives over the year of which two campaigns have started already. And we see already progress in these two campaigns. And so I think that on top of the stabilization, I talked about, we will see additional development and this is satisfying for you as an answer.

    最重要的是,我們在這一年中發起或計劃了許多舉措,其中兩項活動已經開始。我們已經看到這兩項活動取得了進展。因此,我認為除了我談到的穩定性之外,我們還將看到更多的發展,這對您來說是令人滿意的答案。

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Next question.

    下一個問題。

  • Yuan Zhi - Analyst

    Yuan Zhi - Analyst

  • Got it. Thanks for the additional color, and that will be all from my side. Thank you.

    知道了。感謝您提供的額外顏色,這一切都來自我這邊。謝謝。

  • Operator

    Operator

  • Thomas Kerr, Zacks Investment Research.

    托馬斯·克爾,Zacks 投資研究。

  • Thomas Kerr - Analyst

    Thomas Kerr - Analyst

  • Hello, everyone. Some of my questions were just answered but can you give us more color on the India arrangement in terms of time line and that fits your thing?

    大家好。我的一些問題剛剛得到了解答,但您能否就時間安排向我們提供更多有關印度安排的信息,這符合您的要求?

  • And secondly, related to that, the slide said you're approved in the EU, obviously, and it's sold around the world, but is CytoSorb approved and other regions, Asia, South America, et cetera?

    其次,與此相關的是,幻燈片顯然表示您在歐盟獲得了批准,並且它在世界各地銷售,但是 CytoSorb 是否在其他地區(亞洲、南美洲等)獲得批准?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Yeah. Thank you. Kathy or Chris, would you like to comment on the Eris agreement? Or I can?

    是的。謝謝。凱西或克里斯,您想對厄里斯協議發表評論嗎?或者我可以嗎?

  • Kathleen Bloch - Chief Financial Officer

    Kathleen Bloch - Chief Financial Officer

  • I can only say that based on my conversations with the operations people in India, that the transition has gone very smoothly from Biocon to Eris. They've done a lot of train retraining of that. The actual employees of BioQuant who are knowledgeable of CytoSorb have transferred over to Eris. They've been retrained and they are out and are off to a successful beginning of the distribution partnerships.

    我只能說,根據我與印度營運人員的對話,從 Biocon 到 Eris 的過渡非常順利。他們對此進行了大量的訓練再訓練。了解 CytoSorb 的 BioQuant 實際員工已轉移到 Eris。他們已經接受了再培訓,現在已經離職,並開始了分銷合作關係的成功開端。

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Yeah, I think on Biocon was an outstanding partner and but, Eris is a $1 billion US market cap publicly traded company, not as large as Biocon, but a specialty pharma company that is very has been very aggressive in the market and has been able to really take assets and grow them very impressively. We have a temporary agreement that has the same terms as the distribution agreement that we have with Biocon with the exception of the expiration of the date of the agreement, which has been updated from September 2026 to now December 2020 -- to September 2026 from what was formerly December 2025 to basically give Eris some additional time in the market.

    是的,我認為 Biocon 是一個出色的合作夥伴,但是,Eris 是一家美國市值 10 億美元的上市公司,規模不如 Biocon,但它是一家在市場上非常積極的專業製藥公司,並且能夠真正獲得資產並以令人印象深刻的方式成長它們。我們簽訂了一份臨時協議,其條款與我們與Biocon 簽訂的分銷協議相同,但協議的到期日期除外,該協議已從2026 年9 月更新至現在的2020 年12 月,從2026 年9 月更新至2026 年9 月。之前是 2025 年 12 月,基本上是為了給 Eris 在市場上提供一些額外的時間。

  • To get their feet wet with CytoSorb and to see what it can do. We expect to enter into good faith agreements and we can negotiate you are agreement with Eris and that wall it's happening hopefully sometime in the near future.

    讓他們體驗一下 CytoSorb,看看它能起到什麼作用。我們希望達成善意協議,並且我們可以與 Eris 進行談判,希望在不久的將來,這堵牆能夠實現。

  • Thomas Kerr - Analyst

    Thomas Kerr - Analyst

  • And the second part of the question was we're also famous for absorb right now as confused by why the slides in the presentation.

    問題的第二部分是,我們現在也以吸收而聞名,因為對簡報中幻燈片的原因感到困惑。

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Yes. So CytoSorb [saw] that in fact, all over the world with the notable exception of the United States, Japan and China. But for example, we are in most of the -- I think if not all of the European Union countries for in many countries in Southeast Asia; for example, Singapore, Thailand, Vietnam, Hong Kong, South Korea, et cetera. We are in Russia. We are in many countries in the Middle East. We are in Australia and New Zealand. We are in India. And we are in many countries in Latin America.

    是的。因此,CytoSorb [看到]事實上,除了美國、日本和中國之外,世界各地都是如此。但舉例來說,我們在大多數——我想,如果不是所有歐盟國家,以及東南亞的許多國家;例如新加坡、泰國、越南、香港、韓國等。我們在俄羅斯。我們在中東的許多國家。我們在澳洲和紐西蘭。我們在印度。我們在拉丁美洲的許多國家都有業務。

  • So in fact, and we also have a footprint in South Africa as well. So not that much in Africa, notable exceptions of the US, Canada, Japan and China. But otherwise, we have a fairly broad footprint around the world where we leverage our EU approval to be able to sell in these countries.

    事實上,我們在南非也有足跡。因此,非洲的情況不多,美國、加拿大、日本和中國是明顯的例外。但除此之外,我們在世界各地都有相當廣泛的足跡,我們利用歐盟的批准能夠在這些國家銷售。

  • Thomas Kerr - Analyst

    Thomas Kerr - Analyst

  • Got it. Okay. Yeah [we'll quite] sure about that. But a normal quarterly burn rate for 2024, it used to be in the $4 million to $4.5 million range with all the cost savings initiatives will it fall below that? Do you think in 2024 on a quarterly basis?

    知道了。好的。是的,[我們非常]確定這一點。但 2024 年正常的季度燒錢率過去在 400 萬至 450 萬美元範圍內,如果採取所有成本節約舉措,燒錢率會低於這個數字嗎?您認為2024年按季度計算嗎?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Kathy, do you want to take up?

    凱西,你想參加嗎?

  • Kathleen Bloch - Chief Financial Officer

    Kathleen Bloch - Chief Financial Officer

  • Yes. So yes, you won't see the full impact of the cost-cutting measures in the first quarter of the year because there are some times some severance or other costs associated with the implementation. But you can expect our cash burn to be reduced to something around the order of $3 million a quarter in the last two quarters of the year.

    是的。所以,是的,您不會在今年第一季看到成本削減措施的全部影響,因為有時會產生與實施相關的遣散費或其他成本。但您可以預期,今年最後兩季我們的現金消耗將減少至每季約 300 萬美元。

  • Thomas Kerr - Analyst

    Thomas Kerr - Analyst

  • Okay. And that [I was just] little surprising stuff to support the drug ATR development and that stuff. So the recovery I was assuming?

    好的。[我只是]支持藥物 ATR 開發之類的東西,這有點令人驚訝。那我假設的恢復情況是怎麼樣的呢?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • We actually still have clinical trial costs in terms of winding down STAR-D, winding down STAR-T. And we also have clinical programs ongoing such as the COSMOS Registry, our STAR Registry and our process randomized controlled trial that is running in Germany. So there is still significant clinical spend that we are undertaking in 2024. But that being said, the burn will be dramatically lower than it was last year.

    實際上,在逐步結束 STAR-D、逐步結束 STAR-T 方面,我們仍有臨床試驗成本。我們也正在進行臨床項目,例如 COSMOS 註冊、STAR 註冊以及在德國運行的製程隨機對照試驗。因此,我們在 2024 年仍將承擔大量臨床支出。但話雖如此,燃燒量將大大低於去年。

  • And our goal is to, obviously, as Kathleen mentioned, in her presentation, cash conservation is key, right? And I think we detailed many cost-cutting efforts, not just a 15% workforce reduction, but you know, cutting nonessential programs, particularly on the R&D side as well as things even like a third-year of salary freezes for executives, for example.

    顯然,正如凱瑟琳在她的演講中提到的那樣,我們的目標是,節省現金是關鍵,對嗎?我認為我們詳細介紹了許多削減成本的努力,不僅僅是削減 15% 的勞動力,而且你知道,削減不必要的項目,特別是在研發方面,甚至包括高管第三年的工資凍結等。 。

  • And so there's a lot of things across the board that we've been doing in challenging financing environment. But we hope that with additional operational progress this year that the value in our company begins to be unlocked and it allows us to capitalize upon that.

    因此,在充滿挑戰的融資環境中,我們一直在做很多全面的事情。但我們希望,隨著今年營運的進一步進展,我們公司的價值開始被釋放,並讓我們能夠利用這一點。

  • Thomas Kerr - Analyst

    Thomas Kerr - Analyst

  • Got it. That makes sense. And last question, the current share count close to the 10-K filing new [unit] on the SEC website or your website?

    知道了。這就說得通了。最後一個問題,目前的股票數量接近 SEC 網站或您網站上的 10-K 備案新[單位]?

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Kathy, you have that number?

    凱西,你有那個號碼嗎?

  • Kathleen Bloch - Chief Financial Officer

    Kathleen Bloch - Chief Financial Officer

  • Yes. So our common shares outstanding right now are $54.2 million. And then in addition, we have options warrants and RSUs, which bring our fully diluted common shares outstanding to $67.9 million. And I can send you that breakdown if that would help you, Tom.

    是的。因此,我們目前已發行的普通股為 5,420 萬美元。此外,我們還有選擇權認股權證和 RSU,這使我們完全稀釋後的流通普通股達到 6,790 萬美元。湯姆,如果這對您有幫助的話,我可以將詳細資訊發送給您。

  • Operator

    Operator

  • There are no further questions at this time. I would like to turn the call back to management for any additional or closing remark.

    目前沒有其他問題。我想將電話轉回給管理層,以獲取任何補充或結束語。

  • Phillip Chan - Chief Executive Officer

    Phillip Chan - Chief Executive Officer

  • Well, thank you, everyone, for joining the call today. If you do have any other questions, please feel free to reach out to Kathy Bloch at kbloch@cytosorbents.com, and we will reply to your questions where possible. We'll look forward to the next quarterly call. Thank you, everyone very much. Have a good night.

    好的,謝謝大家今天加入電話會議。如果您還有任何其他問題,請隨時透過 kbloch@cytosorbents.com 聯絡 Kathy Bloch,我們將盡可能回覆您的問題。我們期待下一次季度電話會議。非常感謝大家。祝你晚安。

  • Operator

    Operator

  • Thank you. That concludes our conference for today. I'd like to thank everyone for their participation. You may now disconnect.

    謝謝。我們今天的會議到此結束。我要感謝大家的參與。您現在可以斷開連線。