Cytosorbents Corp (CTSO) 2026 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Cytosorbents' first-quarter 2026 earnings conference call.

各位女士、先生，下午好，歡迎參加 Cytosorbents 2026 年第一季財報電話會議。

(Operator Instructions)

(接線員指示)

As a reminder, this call is being recorded. And now I would like to turn the conference over to Pete Mariani, Chief Financial Officer. Please go ahead.

提醒各位，本次電話會議將被錄音。現在我想把會議交給財務長 Pete Mariani。請開始。

Thank you, Kathleen, and good afternoon, everyone. Welcome to Cytosorbents' first-quarter 2026 Conference Call.

謝謝你，Kathleen，各位下午好。歡迎參加 Cytosorbents 2026 年第一季電話會議。

Joining me today is Dr. Phil Chan, our Chief Executive Officer; and Dr. Makis Deliargyris, our Chief Medical Officer.

今天與我一同出席的有我們的執行長 Phil Chan 博士，以及我們的醫務長 Makis Deliargyris 博士。

Before I turn the call over to Phil, 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.

在我把電話交給 Phil 之前，我想提醒聽眾，管理層在本次電話會議中的預先準備發言可能包含前瞻性陳述，而此類陳述受風險與不確定性影響。管理層也可能在回覆各位提問時作出額外的前瞻性陳述。

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. The forward-looking statements may make -- we make reflect our views and estimates as of today, May 13, 2026, and we assume no obligation to update these projections in the future as market conditions change.

因此，公司主張適用《1995 年私人證券訴訟改革法案》中關於前瞻性陳述的「安全港」保護。實際結果可能與今日討論的結果不同。我們所作的前瞻性陳述反映我們截至今日（2026 年 5 月 13 日）的觀點與估計，且在市場狀況變化時，我們不承擔未來更新這些預測的義務。

We encourage investors to review the risks discussed in our annual report on Form 10-K filed with the SEC on March 30, 2026. And as updated by the risks reported in our quarterly reports on Form 10-Q and in press releases and other communications to shareholders issued from time to time.

我們鼓勵投資人查閱我們於 2026 年 3 月 30 日向美國證券交易委員會（SEC）提交的 Form 10-K 年報中所討論的風險。以及我們不時在 Form 10-Q 季報、新聞稿與其他對股東的溝通中所更新揭露的風險。

During today's call, we will have an overview presentation covering the operating and financial results for the first-quarter of 2026 and provide a regulatory update on our process to obtain US marketing approval for DrugSorb-ATR. Following the presentation, we will open the lines to analysts for questions.

在今天的電話會議中，我們將進行概覽簡報，涵蓋 2026 年第一季的營運與財務結果，並就我們取得 DrugSorb-ATR 美國上市核准的流程提供法規進度更新。簡報結束後，我們將開放分析師提問。

And now I'll turn the call over to Phil. Phil?

現在我把電話交給 Phil。Phil？

Thank you very much, Pete, and good afternoon, everyone. Before I start, I'd like to remind everyone of the current regulatory status of our products. CytoSorb is commercially approved in the European Union and many international markets for multiple indications including cytokine removal, Bilirubin and Myoglobin removal and removal of certain antithrombotic agents during cardiothoracic surgery.

非常感謝你，Pete，各位下午好。在我開始之前，我想提醒各位我們產品目前的法規狀態。CytoSorb 已在歐盟及多個國際市場取得商業核准，適用於多項適應症，包括細胞激素移除、膽紅素與肌紅蛋白移除，以及在心胸外科手術期間移除特定抗血栓藥物。

However, CytoSorb is not currently approved or cleared in the United States or Canada outside of its prior emergency use authorization during COVID-19. Similarly, DrugSorb-ATR remains an investigational device and is not commercially approved in any geography at this time.

然而，除先前在 COVID-19 期間取得的緊急使用授權外，CytoSorb 目前尚未在美國或加拿大獲得核准或許可。同樣地，DrugSorb-ATR 仍屬研究用器材，目前在任何地區都尚未取得商業核准。

I'll begin with an operational overview of the quarter and our continued efforts to strengthen and streamline the business, while positioning the company for future growth. Cytosorbents today is built around a differentiated blood purification platform technology designed to remove harmful substances directly from the bloodstream in critically ill and cardiac surgery patients.

我將先從本季的營運概覽開始，並說明我們持續強化與精簡業務的努力，同時讓公司為未來成長做好布局。Cytosorbents 目前以差異化的血液淨化平台技術為核心，旨在直接從血液中移除有害物質，服務於重症與心臟手術患者。

What continues to make this business attractive is the combination of a high-value therapy with a highly scalable razor blade type recurring revenue model that integrates into the existing blood pump infrastructure in hospitals. Our core CytoSorb business continues to expand internationally, generating core product sales of more than $37 million in 2025 with over 300,000 devices used cumulatively in more than 70 countries around the world.

使這項業務持續具吸引力的，是高價值療法與高度可擴展、類似「剃刀與刀片」的經常性收入模式之結合，且可整合至醫院既有的血液幫浦基礎設施中。我們的核心 CytoSorb 業務持續在國際市場擴張，2025 年核心產品銷售額超過 3,700 萬美元，累計在全球 70 多個國家使用超過 300,000 台裝置。

At the same time, DrugSorb-ATR represents a potentially transformational opportunity in cardiac surgery and blood thinner removal. We continue to believe the unmet need here is substantial. And importantly, we now have clear direction from FDA regarding the path forward. We will also discuss a potential parallel path to US regulatory approval as well.

同時，DrugSorb-ATR 在心臟手術與抗凝血藥物移除方面代表一個可能帶來變革的機會。我們仍然相信此處的未被滿足需求相當龐大。更重要的是，我們現在已從 FDA 獲得關於後續推進路徑的明確指引。我們也將討論一條可能的並行路徑，以取得美國法規核准。

Turning to our first-quarter performance. Revenue grew 2% year-over-year to $8.9 million, despite several temporary external headwinds. One of the most encouraging developments was the continued deceleration in our Direct International business outside Germany, which grew 13% year-over-year. We believe this reflects improving physician awareness, stronger execution and increased adoption in key accounts, particularly driven by an outstanding team. In Germany, sales declined mostly year-over-year.

接著談第一季表現。儘管面臨數項暫時性的外部逆風，營收仍年增 2% 至 890 萬美元。最令人鼓舞的發展之一，是我們在德國以外的直營國際業務持續改善並加速成長，年增 13%。我們認為這反映了醫師認知度提升、執行力更強，以及在關鍵客戶的採用增加，尤其是由一支表現卓越的團隊所帶動。在德國，銷售額大多呈現年減。

But operationally, we are actually very encouraged by the progress we're seeing. Our smaller and more focused commercial organization is executing better, productivity has improved and customer engagement has strengthened under new leadership.

但就營運而言，我們其實對所看到的進展感到非常振奮。在新領導下，我們規模更小且更聚焦的商業組織執行得更好，生產力提升，客戶互動也更為強化。

As we stabilize the market, we plan to selectively rebuild portions of the sales force to expand coverage and reaccelerate growth. Distributor sales were flat overall, but were negatively impacted by geopolitical disruption in the Middle East, particularly surrounding the US Iran war, which delayed approximately $0.5 million in expected orders, primarily affecting our Dubai subsidiary and portions of the broader EMEA region. From a margin perspective, gross margins remained strong at 69%. The modest decline versus last year was intentional as we strategically slowed production levels to reduce inventory and improve working capital efficiency.

隨著我們穩定市場，我們計畫有選擇性地重建部分銷售團隊，以擴大覆蓋並重新加速成長。經銷商銷售整體持平，但受到中東地緣政治動盪的負面影響，特別是圍繞美伊戰爭的情勢，導致約 50 萬美元的預期訂單延後，主要影響我們的杜拜子公司以及更廣泛的 EMEA 地區部分市場。就毛利率而言，毛利率仍維持強勁於 69%。相較去年小幅下滑是刻意為之，因我們策略性地放緩生產水準，以降低庫存並提升營運資金效率。

Importantly, we continue to make operational improvements within manufacturing that we believe will support future profitability. One of the most important areas of progress for CytoSorb globally has been the continued refinement of how physicians use the therapy in clinical practice. Increasingly, we believe successful outcomes depend on identifying the right patient, initiating therapy at the right time and applying the appropriate treatment intensity or in other words, a dosing strategy. This evolving treatment paradigm is helping physicians optimize the use of CytoSorb across a wide variety of highly acute and often life-threatening conditions.

重要的是，我們持續在製造端進行營運改善，我們相信這將支持未來的獲利能力。CytoSorb 在全球最重要的進展之一，是醫師在臨床實務中使用該療法方式的持續精進。我們愈來愈相信，成功的結果取決於辨識正確的病患、在正確的時間啟動治療，以及施以適當的治療強度，換言之，就是劑量策略。這種不斷演進的治療典範，正協助醫師在多種高度急性、且往往危及生命的狀況下，最佳化 CytoSorb 的使用。

Today, CytoSorb is being used in many conditions, including septic shock, trauma, rhabdomyolysis, liver failure, acute respiratory distress syndrome, cytokine storm, many different types of infectious diseases, post-surgical complications, transplant medicine, pancreatitis and increasingly blood thinner removal during cardiac surgery, just to name a few. We are working to define what the right patient looks like in each of these situations. Meanwhile, we continue to teach centers that early intervention is critical to the success of our therapy.

目前，CytoSorb 已被用於多種病況，包括敗血性休克、創傷、橫紋肌溶解、肝衰竭、急性呼吸窘迫症候群、細胞激素風暴、多種不同類型的感染性疾病、術後併發症、移植醫學、胰臟炎，以及愈來愈多的心臟手術期間抗凝血藥物移除等，僅舉數例。我們正致力於界定在上述每種情境下「合適的病患」應具備的特徵。同時，我們持續教育各中心：早期介入對我們療法的成功至關重要。

This right timing is being enabled by our stand-alone PuriFi pump that enables easy treatment without a patient needing to be in renal failure on dialysis. We have placed more than 100 of these pumps internationally and believe it's an important part of our enablement strategy. Furthermore, just like antibiotics, to have the best outcome and to fully control the out-of-control inflammatory response users need to treat for the right duration and intensity. This right dosing is being facilitated by our recent launch of the HotSwap device, which enables the rapid exchange of CytoSorb devices. It continues to generate excellent reviews.

這個「正確時機」得以實現，部分歸功於我們的獨立式 PuriFi 幫浦，使患者即使未因腎衰竭而接受透析，也能輕鬆進行治療。我們已在國際市場部署超過 100 台此類幫浦，並相信這是我們推動使用策略的重要一環。此外，就像抗生素一樣，為了獲得最佳結果並充分控制失控的發炎反應，使用者需要以正確的療程時間與強度進行治療。這個「正確劑量」正透過我們近期推出的 HotSwap 裝置來促成，該裝置可快速更換 CytoSorb 裝置。它持續獲得極佳評價。

As physicians gain more experience with the technology and treatment protocols continue to evolve, we believe this growing body of real-world experience strengthens both the clinical value proposition, the clinical conviction and the commercial opportunity for the platform.

隨著醫師對該技術累積更多經驗、治療流程持續演進，我們相信這些日益增加的真實世界經驗，將同時強化該平台的臨床價值主張、臨床信心與商業機會。

In addition to the clinical performance, we continue to see growing evidence, supporting the economic value proposition of our CytoSorb therapy. This study from a Swiss high-volume center evaluated 246 septic shock patients and demonstrated important differences in outcomes between standard of care alone and standard of care plus CytoSorb therapy. Despite treating sicker patients at baseline, the CytoSorb group demonstrated significantly shorter ICU stays, shorter overall hospital stays and reduced ventilation times for survivors that averaged approximately each about six to seven days.

除了臨床表現之外，我們也持續看到越來越多證據支持 CytoSorb 療法的經濟價值主張。這項來自瑞士高量能中心的研究評估了 246 名敗血性休克患者，並顯示僅採標準治療與標準治療加上 CytoSorb 療法之間，在結果上存在重要差異。儘管基線時治療的是病情更嚴重的患者，CytoSorb 組仍顯示顯著更短的加護病房（ICU）住院天數、更短的整體住院天數，以及存活者更短的呼吸器使用時間，平均各約縮短 6 至 7 天。

Also, CytoSorb used significantly lowered nursing workload intensity. Importantly, these operational improvements translated into meaningful improved financial outcomes for the hospital system itself with significantly higher net earnings per patient case. We believe this type of data is increasingly important in today's health care environment where hospitals are under growing pressure to improve efficiency, optimize ICU resource utilization, reduce length of stay and manage staffing burdens. The ability to potentially improve both clinical and economic outcomes simultaneously remains an important differentiator for our technology.

此外，CytoSorb 的使用也顯著降低了護理工作負荷強度。更重要的是，這些營運面的改善為醫院體系本身帶來了具實質意義的財務成果改善，使每個病案的淨收益顯著提高。我們認為，在當今的醫療照護環境中，這類數據愈來愈重要；醫院正承受日益增加的壓力，需要提升效率、最佳化加護病房（ICU）資源使用、縮短住院天數並管理人力配置負擔。能夠同時潛在改善臨床與經濟結果的能力，仍是我們技術的一項重要差異化優勢。

At this point, I'll turn the call over to Dr. Makis Deliargyris, our Chief Medical Officer, to discuss our clinical and regulatory progress. Makis?

接下來，我將把電話會議交給我們的首席醫療長 Makis Deliargyris 醫師，請他說明我們在臨床與法規方面的進展。Makis？

Thank you, Phil, and good afternoon to everyone joining our call. Before we move on to the regulatory updates, it's important to review, once again, the problem that we're trying to solve the DrugSorb-ATR. And that problem is blood thinners and cardiac surgery.

謝謝你，Phil，也向所有加入本次電話會議的各位致上下午好。在我們進入法規更新之前，有必要再次回顧我們試圖以 DrugSorb-ATR 解決的問題。而這個問題就是抗凝血藥物與心臟手術。

As of today, tens of millions of patients worldwide are on this direct oral anticoagulants like Eliquis or Xarelto or anti-platelet agents like Brilinta that they take those medications either acutely to reduce risks of heart attacks or chronically to reduce their risk of stroke, new heart attacks or serious thrombotic complications. These patients, on an average, need surgery about 1% to 2% of them every year frequently emergent surgery, which usually is cardiac surgery since they suffer from cardiovascular disease.

截至今日，全球有數千萬名患者正在使用這類直接口服抗凝血藥（DOAC），例如 Eliquis 或 Xarelto，或使用抗血小板藥物如 Brilinta；他們服用這些藥物，可能是急性期用以降低心肌梗塞風險，或是長期用以降低中風、新的心肌梗塞或嚴重血栓併發症的風險。這些患者平均每年約有 1% 到 2% 需要手術，且往往是緊急手術；通常是心臟手術，因為他們罹患心血管疾病。

Specifically, among all emergency cardiac procedures, about 5% to 10% of patients are on chronic drug therapy at the time of surgery. Similarly, among heart attack patients who are treated with anti-platelet drugs like Brilinta, about 5% to 10% of them are not eligible for a stent and do require also urgent CABG surgery. The problem arises by the fact that the blood thinners when present during surgery, this significantly and substantially increased the risk for severe frequently life-threat bleeding. Currently, the only option for these patients is to delay surgery for multiple days and to allow for drug clearance out of the body.

具體而言，在所有緊急心臟手術中，約有 5% 到 10% 的患者在手術時正接受慢性藥物治療。同樣地，在使用 Brilinta 等抗血小板藥物治療的心肌梗塞患者中，約有 5% 到 10% 不適合置放支架，且也確實需要緊急進行冠狀動脈繞道手術（CABG）。問題在於：當手術期間體內仍有抗凝血藥物存在時，會顯著且大幅提高嚴重、且常常危及生命的出血風險。目前，這些患者唯一的選項是將手術延後數天，讓藥物從體內代謝清除。

However, this is far from a perfect solution. First of all, many patients simply cannot wait. The situation is too acute, too critical, and they cannot afford multiple day delays and need to proceed for emergency surgery. Second, even among those who can wait, they are exposed to potentially additional complications during this waiting period, severe complications, including death, and at the same time, they're consuming valuable hospital resources like intensive care beds simply waiting for a drug to wash out. And this is where DrugSorb-ATR, a twice designated FDA breakthrough device, has the potential to address this pervasive and serious unmet medical need.

然而，這遠非完美的解決方案。首先，許多患者根本無法等待。情況過於急迫、過於危重，他們無法承受延後數天，必須進行緊急手術。其次，即便是能等待的患者，在等待期間也可能暴露於額外併發症風險之中，且可能是嚴重併發症，包括死亡；同時，他們也在消耗寶貴的醫院資源，例如加護病房病床，只是為了等待藥物從體內洗出。而這正是 DrugSorb-ATR（獲 FDA 兩次授予突破性醫療器材認定）有潛力解決這項普遍且嚴重未被滿足醫療需求之處。

Next slide, please. In terms of our FDA regulatory update for DrugSorb-ATR and Brilinta, it is important to remind our audience that in August of 2025, we received the FDA decision or appeal of the original de novo submission. FDA upheld the prior denial decision and required additional information, primarily related to real-world evidence on clinical outcomes to support the company's desired label claim that would have to be included in a new de novo submission.

請看下一張投影片。就 DrugSorb-ATR 與 Brilinta 的 FDA 法規更新而言，重要的是提醒各位：在 2025 年 8 月，我們收到了 FDA 對原始 de novo 申請之決定（或上訴結果）。FDA 維持先前的否決決定，並要求補充額外資訊，主要與臨床結果的真實世界證據（real-world evidence）相關，以支持公司期望的標示（label）主張，而該主張必須納入新的 de novo 申請中。

However, there were two very important and very positive outcomes of the appeal process and outlined the appeal decisions. First of all, FDA did not identify any issues with device safety, which is a key to the benefit risk ratio that FDA uses to judge for de novo approval. Second, it's our understanding that FDA agreed that the upcoming submission would be focused only on the remaining open items, potentially giving the opportunity for a focused and expedited review.

不過，上訴流程有兩項非常重要且非常正面的結果，並已在上訴決定中說明。首先，FDA 未指出任何器材安全性問題；而安全性是 FDA 在評估 de novo 核准時，用以判斷效益風險比的關鍵。其次，據我們理解，FDA 同意接下來的申請將僅聚焦於仍未結案的項目，這可能使審查得以更聚焦並加速。

In January 2026, we held a formal pre-submission meeting with FDA and have since continued to have interactive discussions with FDA to confirm the requirements for the new de novo submission, including whether all the requested information would be needed in the submission itself or whether it could be a post-marketing requirement. During these discussions, FDA has requested that additional mechanistic data be included together with the real world evidence within the new de novo submissions.

在 2026 年 1 月，我們與 FDA 舉行了正式的預先提交（pre-submission）會議，之後也持續與 FDA 進行互動式討論，以確認新的 de novo 申請所需的要求，包括：所有被要求的資訊是否都必須納入申請本身，或是否可作為上市後要求（post-marketing requirement）。在這些討論中，FDA 要求在新的 de novo 申請中，除真實世界證據外，亦需納入額外的機轉性（mechanistic）數據。

Accordingly, we are evaluating the options to generate the additional mechanistic data which we plan to discuss with FDA and incorporate their feedback before completing the required work. This will likely delay the new de novo application submission to late 2026, early 2027. However, we now have a clear direction from FDA, and we plan to file as soon as possible. Following submission, a regulatory decision is typically expected within a 150-day review period, although timelines may be accelerated or extended based on the nature and scope of FDA interactions during the review process.

因此，我們正在評估產生額外機轉性數據的各種選項；我們計畫與 FDA 討論並在完成所需工作前納入其回饋。這可能會使新的 de novo 申請提交時間延後至 2026 年底、2027 年初。不過，我們現在已從 FDA 獲得明確方向，並計畫儘快提出申請。提交後，法規決定通常預期在 150 天的審查期內出爐，但時程可能因審查期間與 FDA 互動的性質與範圍而加速或延長。

Next slide. Meanwhile, the main results of the STAR-T randomized clinical trial are now published and available online. In the paper that you see on the slide, the front page, the principal investigators of the study, together with the executive committee and the top enrollers summarize the main observation from the STAR-T trial. The paper is available online, open access, which means you can feel free to download it for free, and we urge you to do so and read it in great detail. However, we'd like to highlight the central message as the authors and the editors of the journal selected.

請看下一張投影片。同時，STAR-T 隨機臨床試驗的主要結果現已發表並可於線上取得。在投影片所示的論文（封面頁）中，該研究的主要研究者與執行委員會及主要收案中心共同總結了 STAR-T 試驗的主要觀察結果。該論文已於線上以開放取用（open access）形式提供，表示各位可免費下載；我們也鼓勵各位下載並仔細閱讀。不過，我們想特別強調作者與期刊編輯所選定的核心訊息。

By the way, it's important to note that the journal that published the paper is the most read journal by American cardiac surgeons, the journal of thoracic and cardiovascular surgery. In the central message, the authors concluded that DrugSorb-ATR used for ticagrelor removal is safe and can reduce the severity of bleeding after isolated CABG in patients operated within two days of drug discontinuation. And what you see on the graph is a more than 50% reduction in the composite of severe bleeding events either defined by a standardized bleeding definition or via the volume of blood loss after surgery, with the use of the device.

順帶一提，值得注意的是，發表該論文的期刊是美國心臟外科醫師閱讀率最高的期刊——《胸腔與心血管外科期刊》（Journal of Thoracic and Cardiovascular Surgery）。在核心訊息中，作者結論指出：DrugSorb-ATR 用於移除替卡格雷（ticagrelor）是安全的，並可降低在停藥兩天內接受單純 CABG 手術患者的術後出血嚴重程度。圖表顯示，使用該器材可使嚴重出血事件的複合指標降低超過 50%；該指標可依標準化出血定義界定，或以術後失血量衡量。

Next slide. Today, we would also like to share an additional regulatory update and a potential (technical difficulty) goal, specifically relating to the removal of DOAC. We have previously discussed our intention to pursue an expanded label for DrugSorb-ATR to include the removal of direct oral anticoagulations -- anticoagulants following initial marketing approval for ticagrelor removal.

請看下一張投影片。今天，我們也想分享另一項法規更新以及一項潛在（技術困難）的目標，特別與 DOAC 的移除相關。我們先前曾討論過：在替卡格雷移除取得初始上市核准後，我們有意為 DrugSorb-ATR 申請擴大標示，以納入直接口服抗凝血藥（DOAC）——抗凝血藥物的移除。

However, meanwhile, real-world evidence and publications continue to grow for the DOAC removal indications. As such, within the next 30 days, we plan to submit a separate pre-submission request to FDA to review the data that is currently available for the DOAC indication and determine what, if any, additional information may be required to support a parallel de novo submission for DOAC removal.

然而，與此同時，針對 DOAC 移除適應症的真實世界證據與文獻仍在持續增加。因此，在未來 30 天內，我們計畫向 FDA 提交一份獨立的預先提交（pre-submission）申請，請 FDA 審閱目前可得的 DOAC 適應症資料，並判定若要支持一項平行的 DOAC 移除 de novo 申請，是否需要任何額外資訊，以及需要哪些資訊。

This strategy is consistent with the, already received, second FDA breakthrough device designation for DrugSorb-ATR to remove drugs during cardiac surgery. As we previously stated, tens of millions of these patients are on chronic or lifelong DOAC for diseases such as atrial fibrillation, deep venous thrombosis or pulmonary embolism.

此一策略與我們已獲得的第二項 FDA 突破性醫療器材認定一致，即 DrugSorb-ATR 用於在心臟手術期間移除藥物。如我們先前所述，數千萬名此類患者因心房顫動、深部靜脈血栓或肺栓塞等疾病，長期或終身使用 DOAC。

In fact, Eliquis is the number seven pharmaceutical in the world with $14.4 billion in sale -- in global sales in 2025, whereas Xarelto is also a blockbuster with $5.1 billion in sales in 2025, and they are the market leaders of the category. Therefore, potential FDA marketing approval for both Brilinta and DOAC removal in cardiac surgery could expand the total addressable market for DrugSorb-ATR to $500 million, up to $1 billion in the US alone.

事實上，Eliquis 是全球第七大藥品，2025 年全球銷售額達 144 億美元；而 Xarelto 也是重磅藥物，2025 年銷售額達 51 億美元，兩者皆為該類別的市場領導者。因此，若能在心臟手術中同時取得 Brilinta 與 DOAC 移除的 FDA 上市核准，可能將 DrugSorb-ATR 的總可服務市場擴大至 5 億美元，甚至在美國單一市場上看至 10 億美元。

Next slide, please. Finally, I'd like to share some exciting news about some upcoming presentations in two very important cardiovascular conferences. The evidence base for antithrombotic removal in cardiac surgery continues to grow. And as such, we have been submitting original analysis to some of the most attended conferences worldwide. Specifically at the EuroPCR meeting that is taking place next week in Paris, which happens to be the world's leading course in interventional cardiology, we have two key presentations will be made on antithrombotic removal.

請下一張投影片。最後，我想分享一些令人振奮的消息，關於即將在兩個非常重要的心血管會議上進行的簡報。心臟手術中抗血栓藥物移除的證據基礎持續擴增。因此，我們已向全球出席人數最多的一些會議提交原創分析。具體而言，在下週於巴黎舉行的 EuroPCR 會議（亦為全球介入性心臟病學領域的領先課程）上，我們將有兩場關於抗血栓藥物移除的重點發表。

The first one titled Urgent CABG in ACS, impact of P2Y12 inhibitor choice and intraoperative hemoadsorption on perioperative bleeding, a propensity score matched analysis of real-world data. This is a comparison of strategies employed today in everyday practice. We're comparing outcomes from hospitals that use routinely ticagrelor and our device during urgent surgery versus the outcomes observed among hospitals who opt for a different antiplatelet drug, like clopidogrel or Plavix and they do not use the device. Using sophisticated statistical methods to ensure that the populations are comparable, we're able to see the difference -- the choice of P2Y12 and device use can make when it comes to bleeding.

第一場題為：ACS 中的緊急 CABG：P2Y12 抑制劑選擇與術中血液吸附對圍手術期出血的影響——真實世界資料的傾向分數配對分析。這是對當今日常臨床實務所採用策略的比較。我們比較在緊急手術中例行使用替格瑞洛（ticagrelor）並使用我們裝置的醫院之結果，與選擇不同抗血小板藥物（如氯吡格雷或 Plavix）且不使用該裝置的醫院所觀察到的結果。透過精密的統計方法以確保族群具有可比性，我們得以看出差異——在出血方面，P2Y12 的選擇與裝置使用所能帶來的影響。

The second presentation, specifically on DOAC removal during CABG. This is going to be the first data we present to this audience. And these are data that are coming from the STAR registry, again, showing that it's not just Brilinta, but also Eliquis and Xarelto that are frequently on board in patients required urgent CABG. Later this year, in Munich at ESC 2026, which is taking place at the end of August, which happens to be the world's largest cardiovascular conference. We have two additional analysis being presented on antithrombotic removal during cardiac surgery.

第二場發表則聚焦於 CABG 期間的 DOAC 移除。這將是我們首次向此受眾呈現的資料。這些資料來自 STAR 登錄研究，再次顯示在需要緊急 CABG 的病人中，不僅是 Brilinta，Eliquis 與 Xarelto 也常常正在使用中。今年稍晚，在慕尼黑舉行的 ESC 2026（於八月底舉行，亦為全球最大的心血管會議）上，我們還將發表另外兩項關於心臟手術中抗血栓藥物移除的分析。

Again, we're talking about the ticagrelor removal during urgent CABG, but we're comparing to hospitals who also use ticagrelor, but do not use the device.

同樣地，我們將討論緊急 CABG 期間的替格瑞洛移除，但我們會與同樣使用替格瑞洛、但不使用該裝置的醫院進行比較。

Again, very sophisticated statistical methods are being employed on patient-level data to ensure these populations are appropriate for comparison. And then finally, a very exciting analysis from the collection of German Heart Centers who have incorporated their device as part of their routine care to treat multiple different types of blood thinners.

同樣地，我們將在病人層級資料上採用非常精密的統計方法，以確保這些族群適合進行比較。最後，還有一項令人非常振奮的分析，來自一群德國心臟中心的資料彙整；這些中心已將其裝置納入常規照護的一部分，用於處理多種不同類型的抗凝血藥物。

So this analysis is not specific on any one blood thinner, but simply the strategy of using a device whenever patients or blood thinners require urgent CABG. Now this analysis and the data are embargoed until the date of release at the conference, so we cannot go into more details. But obviously, we're very excited about this release of this new data that we believe highlight the increasing adoption of our technology by leading Heart Centers in Europe and their enthusiasm around the reductions in bleeding they're experiencing with the use of our device as part of their protocols for patients from blood thinners.

因此，這項分析並非針對任何單一抗凝血藥物，而是聚焦於一項策略：當病人正在使用抗凝血藥物且需要緊急 CABG 時，即使用該裝置。目前此分析與資料在會議發布日期前均受禁運限制，因此我們無法提供更多細節。但顯然，我們對這批新資料的發布感到非常興奮；我們相信這些資料凸顯了歐洲領先心臟中心對我們技術日益提高的採用度，以及他們對於將我們裝置納入其針對使用抗凝血藥物病人的流程後所觀察到之出血降低效果的熱忱。

It's important to note that it's very difficult to get any analysis accepted, these are very competitive conferences. So I think that also shows the enthusiasm among the broader cardiovascular community even among those who do not have access to the device about learning the potential benefit of this novel solution in their everyday practice. So thank you for your attention. And with that, I will turn it over to Pete now.

需要強調的是，要讓任何分析被接受非常困難，這些會議競爭非常激烈。因此，我認為這也顯示更廣泛的心血管社群——即使是那些無法取得該裝置的人——也對於了解這項新穎解決方案在日常實務中的潛在效益抱持高度興趣。感謝各位的聆聽。接下來我把時間交給 Pete。

Thank you, Makis, and good afternoon, everyone. Today, I'll be reviewing the first-quarter 2026 financial performance and important updates that continue to strengthen our business. first-quarter revenue, as Phil noted, was $8.9 million, an increase of 2% over prior year and down 7% on a constant currency basis. As Phil noted, first-quarter revenue includes approximately 13% growth of our International Direct markets, partially offset by lower revenue in our direct German market.

謝謝你，Makis，各位下午好。今天我將回顧 2026 年第一季的財務表現，以及持續強化我們業務的重要更新。如 Phil 所提，第一季營收為 890 萬美元，較去年同期成長 2%，以固定匯率計則下降 7%。如 Phil 所述，第一季營收包含我們國際直營市場約 13% 的成長，部分被德國直營市場營收較低所抵銷。

Although our direct German sales were down over the prior year, we continue to see signs of improved leadership and sales processes, account targeting and customer engagement with a smaller and more focused team and plan to selectively expand this team to improve account coverage and drive growth across cardiac surgery and critical care.

儘管我們德國直營銷售較去年同期下滑，我們仍持續看到改善的跡象，包括在較小且更聚焦的團隊下，領導力與銷售流程、帳戶鎖定以及客戶互動均有所提升；並計畫選擇性擴編該團隊，以改善帳戶覆蓋並推動心臟手術與重症照護領域的成長。

And distributor sales were flat year-over-year as progress across several territories was offset by delayed distributor orders of approximately $500,000 in parts of the Middle East and neighboring regions due to geopolitical and economic instability related to the US Iran war. This unexpected disruption has slowed the anticipated growth of our recently established subsidiary in Dubai, although we expect conditions to improve as the conflict stabilizes.

而經銷商銷售與去年同期持平，因為多個地區的進展被中東部分地區及周邊區域約 50 萬美元的經銷商訂單延遲所抵銷；延遲原因為與美伊戰爭相關的地緣政治與經濟不穩定。這項突如其來的干擾已放緩我們近期在杜拜新設子公司的預期成長，不過我們預期隨著衝突趨於穩定，情勢將有所改善。

Gross margins for Q1 was 69% compared to 71% in the prior year. The lower gross margin reflects a planned reduction in unit production in the quarter, which allowed us to improve working capital and cash burn by lowering inventory levels to $4.8 million at the end of the quarter compared to $5.3 million at the end of the year.

第一季毛利率為 69%，相較去年同期為 71%。毛利率較低反映本季計畫性降低單位產量，使我們得以透過將期末庫存降至 480 萬美元（相較年末 530 萬美元）來改善營運資金與現金消耗。

And operating expenses were $9.2 million for the quarter compared to $10.1 million a year ago. The year-over-year decrease reflects lower research and development and clinical project spend and other compensation costs reflecting initial benefits of our strategic headcount and cost reduction program implemented in the fourth quarter of last year. We expect the costs will continue to decrease sequentially as a full benefit of our cost reduction program develops across the next few quarters.

本季營業費用為 920 萬美元，去年同期為 1,010 萬美元。年對年下降主要反映研發與臨床專案支出降低，以及其他薪酬成本下降，這些都體現了我們於去年第四季實施之策略性人力與成本削減計畫的初步效益。我們預期隨著成本削減計畫在未來幾季逐步完全發揮效益，成本將持續呈現逐季下降。

Our operating loss improved approximately 22% in Q1 to $3 million compared to $3.9 million in the prior year, reflecting the lower operating expenses. Net loss increased to $5.1 million for the quarter or $0.08 per share compared to a net loss of $1.5 million or $0.02 per share in the prior year and it's primarily due to the noncash impact of changes in foreign currency transactions over the year -- or year-over-year. However, adjusted net loss for the quarter which removes the noncash impact of foreign currency gains and losses and noncash stock compensation improved to $3.4 million or $0.05 per share compared to an adjusted net loss of $3.7 million or $0.06 per share in the prior year.

由於營業費用降低，我們第一季營業損失改善約 22%，降至 300 萬美元，去年同期為 390 萬美元。本季淨損擴大至 510 萬美元（每股 0.08 美元），去年同期淨損為 150 萬美元（每股 0.02 美元），主要原因是外幣交易年對年變動所帶來的非現金影響。然而，排除外幣損益的非現金影響及非現金股票薪酬後，本季調整後淨損改善至 340 萬美元（每股 0.05 美元），去年同期調整後淨損為 370 萬美元（每股 0.06 美元）。

Adjusted EBITDA loss for the quarter, which also removes the noncash impact of foreign currency gains and losses and noncash stock compensation improved to $2.2 million compared to an adjusted EBITDA loss of $2.7 million in the prior year. Our total cash, cash equivalents and restricted cash was approximately $6.4 million on March 31 compared to $7.8 million at the end of the year. Total cash burn in the quarter improved to $1.1 million, excluding $300,000 of restructuring-related payments in the quarter. The improvement reflects the initial benefit of our cost reduction program and improved working capital dynamics in the quarter.

本季調整後 EBITDA 損失（同樣排除外幣損益的非現金影響及非現金股票薪酬）改善至 220 萬美元，去年同期調整後 EBITDA 損失為 270 萬美元。截至 3 月 31 日，我們的現金、約當現金及受限制現金合計約為 640 萬美元，較年末的 780 萬美元下降。本季總現金消耗改善至 110 萬美元（不含本季 30 萬美元的重整相關付款）。此改善反映成本削減計畫的初步效益，以及本季營運資金動態的改善。

Fourth quarter of 2025, we implemented the strategic workforce and cost reduction initiative, reducing headcount by approximately 10%, while lowering operating and production expenses. The initial benefits of this program were reflected in lower operating expenses and improved margins in the first-quarter, and we have continued to make additional operational improvements and taken further steps to reduce costs in the first-quarter and believe these actions will continue to drive improvements in the coming quarters in support of our goal of achieving operating cash flow breakeven in the second half of the year.

在 2025 年第四季，我們實施策略性人力與成本削減措施，將人力編制縮減約 10%，同時降低營運與生產費用。該計畫的初步效益已反映在第一季較低的營業費用與改善的毛利率上；我們也在第一季持續進行額外的營運改善並採取進一步降本措施，並相信這些行動將在未來幾季持續帶動改善，以支持我們在今年下半年達成營運現金流損益兩平的目標。

Now I'll turn the call back over to Phil.

現在我把電話會議交回給 Phil。

Thanks, Pete. Overall, while the first-quarter included both macroeconomic and geopolitical challenges related to the US Iran war. We believe the company continues to make meaningful progress across multiple fronts. Operationally, we are improving efficiency and stabilizing key markets.

謝謝你，Pete。整體而言，儘管第一季同時面臨與美伊戰爭相關的總體經濟與地緣政治挑戰，我們相信公司仍在多個面向取得實質進展。在營運方面，我們正提升效率並穩定關鍵市場。

Clinically, the evidence base supporting both CytoSorb and DrugSorb-ATR continues to strengthen, and strategically, we now have greater clarity regarding the FDA pathway moving forward with a dual pathway potentially possible.

在臨床方面，支持 CytoSorb 與 DrugSorb-ATR 的證據基礎持續強化；在策略方面，對於未來推進的 FDA 路徑，我們現在也有了更清晰的認識，且可能存在雙軌路徑的可能性。

Overall, we believe Cytosorbents today represents a compelling combination of an established commercial platform business together with a potentially transformative regulatory growth opportunity. The core CytoSorb business continues generating recurring high-margin revenue globally across critical care and cardiac surgery. Meanwhile, DrugSorb-ATR provides potential long-term upside through two FDA breakthrough device designation, targeting large unmet needs in cardiac surgery patients on blood thinners. At the same time, we are remaining disciplined financially and operationally as we work towards achieving operating cash flow breakeven in the second half of this year.

整體而言，我們認為 Cytosorbents 目前結合了已建立的商業化平台型業務，以及一項可能帶來變革性的監管成長機會，形成極具吸引力的組合。核心的 CytoSorb 業務持續在全球重症照護與心臟手術領域帶來具經常性、高毛利的收入。同時，DrugSorb-ATR 透過兩項 FDA 突破性醫療器材認定，鎖定使用抗凝血藥物的心臟手術患者之重大未被滿足需求，提供潛在的長期上行空間。與此同時，在我們朝今年下半年達成營運現金流損益兩平的目標邁進之際，我們在財務與營運上仍保持紀律。

We believe the company is becoming leaner, more focused, operationally stronger and better positioned for long-term sustainable growth and shareholder value creation. With that, thank you again for joining us today and for your continued support of Cytosorbents. Operator, we are now ready to begin the question-and-answer session.

我們相信公司正變得更精實、更聚焦、營運更強健，並且在長期可持續成長與為股東創造價值方面具備更佳定位。在此，再次感謝各位今天與會，並感謝各位持續支持 Cytosorbents。接線員，我們現在準備開始問答環節。

(Operator Instructions)

(接線員指示)

Michael Sarcone, Jefferies.

Michael Sarcone，Jefferies。

Yes, Phil, thanks for the update around DrugSorb and the regulatory environment. I was wondering if you could elaborate more. You talked about the FDA is requesting additional mechanistic data being included in your new de novo submission. Can you maybe just talk about what are the various scenarios or forms that, that data could take. And what would be the kind of requisite investment required on the part of Cytosorbents.

是的，Phil，感謝你就 DrugSorb 與監管環境的最新進展提供更新。我想請你再多說明一些。你提到 FDA 要求在你們新的 de novo 申請中納入額外的機制性資料。你能否談談這些資料可能採取的各種情境或形式？以及 Cytosorbents 方面大概需要投入哪些必要的資源？

Yes. Thanks, Mike. Let me actually turn it over to Makis to answer that question, and I can provide some additional color after that. Makis?

好的。謝謝你，Mike。我先把這個問題交給 Makis 回答，之後我再補充一些背景說明。Makis？

Yes. Thanks, Phil. And Michael, thank you for the question. So basically, the term mechanistic data refers to the fact that we're moving -- these are non-clinical outcome data that we're looking for. And these are data to support the mechanism of action of the device.

好的。謝謝你，Phil。Michael，也謝謝你的提問。基本上，「機制性資料」這個詞指的是我們正在推進——我們所尋求的是非臨床的結果資料。這些資料用來支持該器材的作用機制。

Now these data are, in general, do not require the resourcing of running a clinical trial, and I think that's why we wanted to make that distinction. These are non-clinical studies we're being asked to run, it's more of experimental designs that will provide this additional information. So we are assessing the options that we have right now in exactly what type of experiments can we generate the information.

一般而言，這些資料不需要投入資源去執行一項臨床試驗，我想這也是我們希望做出這個區分的原因。我們被要求進行的是非臨床研究，更偏向於實驗設計，以提供這些額外資訊。因此，我們正在評估目前可行的選項，具體要用哪些類型的實驗來產生所需資訊。

We're working together with FDA to finalize those designs. We don't have them finalized yet. And as such, we can't comment with any more detail about what that data would look like. However, I just want to make sure that it's clear that these are non-clinical studies that require a long duration of follow-up, multiple patients or multiple sites working together, and therefore, heavy resources to support them. So once we have more clarity and we're able to come to an alignment with FDA.

我們正與 FDA 一起合作，以敲定這些設計。目前尚未定案。因此，我們無法就這些資料的樣貌提供更進一步的細節。不過，我想確保大家清楚：這些是非臨床研究，不需要長時間追蹤、需要多位患者或多個研究中心共同進行，因此需要大量資源來支援。所以一旦我們有更清晰的方向，並能與 FDA 達成一致。

I think at that time, we would potentially disclose more information around the design of these experiments.

我想屆時我們可能會披露更多關於這些實驗設計的資訊。

Okay. And I mean -- but I guess for my own understanding, could that include something like real-world evidence or (technical difficulty) data from a single site? Is that something that could address something like this?

了解。我的意思是——但就我自己的理解，這是否可能包含像是真實世界證據，或是來自單一研究中心的（技術問題）資料？這樣的資料是否能夠解決這類需求？

Yes. I think it's important to understand that these are non-clinical outcomes we're looking for, right? So this is not necessarily to expand the existing real-world evidence that we have, this is supplementary information around the mechanism of action of the device. So these are not clinical outcome trials or experiments that we're talking about.

是的。我認為重要的是要理解：我們要找的是非臨床結果，對吧？因此，這不一定是要擴充我們既有的真實世界證據，而是針對器材作用機制的補充資訊。所以我們談的不是臨床結果試驗或臨床實驗。

And then I guess, my second question or third technically, on the potential for expanding the label, the DOAC, I guess what is your hope you submitted for kind of a pre-submission meeting with the FDA to review some of the data. In the best case scenario, what do you hope the FDA kind of comes back with in terms of the easiest pathway and the most efficient pathway towards getting this expanded label?

那我第二個問題——嚴格說是第三個——關於擴大標示適應症、也就是 DOAC 的可能性：我想你們已提交與 FDA 進行 pre-submission 會議的申請，以審查部分資料。在最佳情境下，你們希望 FDA 在最容易、最有效率的路徑上，對於取得這項擴大標示適應症會給出什麼樣的回覆？

I think that's an excellent question, Michael. But I think to be able to truly give you an answer that's meaningful, that would have to happen after we meet with the FDA. What we're saying today on the update is that we believe we have enough information to go ahead in front of them and basically leverage some of the real-world experience with the device in some of the accumulating publications and data that are out there and see what they would need in addition to what we already have, that may not even need much more. We just don't know how they're going to view the DOAC application in comparison.

我認為這是個非常好的問題，Michael。但要真正給你一個有意義的答案，必須等我們與 FDA 會面之後才行。我們今天更新所要表達的是：我們相信我們已經有足夠資訊可以與他們討論，基本上可運用該器材的一些真實世界使用經驗，以及目前累積的出版文獻與外部資料，看看除了我們既有資料之外他們還需要什麼；而且可能不需要太多額外內容。我們只是不知道他們會如何看待 DOAC 的申請相較之下的要求。

We do have clarity with ticagrelor and Brilinta, but we want to gain a similar clarity with DOAC and we want to have that alignment early on. And that's why now that we believe there's a substantial body of evidence already collected. We want to be able to present to them so we can move forward with (technical difficulty) in fashion to be able to compile the necessary information and proceed with the parallel (technical difficulty) submission for DOAC removal?

對於 ticagrelor 與 Brilinta，我們已有明確方向，但我們希望對 DOAC 也取得類似的明確性，並且希望能在早期就達成一致。因此，既然我們相信目前已累積相當可觀的證據體系，我們希望能向他們提出，以便我們能以（技術問題）的方式向前推進，彙整必要資訊，並就 DOAC 去除適應症進行平行的（技術問題）申請？

Tom Kerr.

Tom Kerr。

A couple of business questions. We don't talk much about the Middle East business. Can you expand on that? Which country? Is it all distributor business? Or is there any direct sales in the Middle Eastern region? Just any more color on that.

幾個業務面的問題。我們不太常談到中東業務。你能多談一些嗎？是哪些國家？是否全部都是經銷商模式？或是在中東地區是否有任何直銷？請再提供一些背景說明。

Yes. Last year, we established our subsidiary in Dubai, UAE and talked about the exciting opportunities in the Middle East, particularly in large countries like Saudi Arabia, where if you look at the historical publications coming out of the Middle East, Saudi Arabia, for example, has been one of the thought leaders in the use of our therapy in COVID and initially, but also in other applications.

好的。去年我們在阿聯酋杜拜設立了子公司，並談到中東地區令人振奮的機會，特別是在像沙烏地阿拉伯這樣的大型國家；如果你看中東地區過往的出版文獻，例如沙烏地阿拉伯在 COVID 期間以及初期，乃至於其他適應症上，都是使用我們療法的意見領袖之一。

But the Middle East is a broad territory, and we believe that there's actually a lot of opportunity given the general wealth in the region and the high quality and standards of medical care. Now obviously, the US Iran war was unexpected.

但中東是一個幅員廣大的區域，我們認為在該地區普遍富裕、且醫療照護品質與標準很高的背景下，實際上存在很多機會。當然，美伊戰爭是出乎意料的。

And I think, as you've seen, has many, many implications across the world economy and in particular, the Middle East, where -- there's been a lot of near-term uncertainty. However, despite some of the back and forth that has gone on, on a daily basis in that region, we do feel that this conflict is temporary and that ultimately, a resolution to these issues will be found.

我想你也看到，這對全球經濟有非常多的影響，尤其是對中東地區——短期內帶來了很大的不確定性。然而，儘管該地區每天都有一些反覆變化的情勢，我們仍認為這場衝突是暫時的，最終將會找到解決這些問題的方案。

And we are planning to be ready to respond in that case. And I would also note that a lot of the conflict creates a lot of injury to a lot of -- unfortunately, to a lot of people. And that is exactly what our therapy is designed to help with. And so we believe that everything that's happening right now just makes it even more compelling of what our technology can help do.

而我們也在規劃，一旦情勢如此發展，我們將準備好做出回應。我也要指出，許多衝突會造成大量——不幸地——對許多人的傷害。而這正是我們的療法所設計要協助處理的情況。因此，我們認為目前發生的一切，反而讓我們的技術能夠提供的幫助更具說服力。

Got it. All right. That makes sense. One more finance question. On the gross margins in inventory, sorry if I missed this, but are the inventory levels where you want to be? Or will there be continued sort of drag on gross margin this quarter or next quarter?

了解。好。這很合理。再一個財務問題。關於毛利率與庫存，抱歉如果我漏聽了，但目前庫存水位是在你們希望的水準嗎？還是本季或下季毛利率仍會持續受到某種拖累？

Yes, Tom, we're -- we have inventory levels, I think, will continue to come down a little bit. So I think that instead of accelerating gross margins, I think they'll be in that -- we did 69% this quarter. I mean we could be in that high 60s, low 70s here until we balance this out a bit more.

是的，Tom，我們——我認為我們的庫存水位將會再小幅下降一些。因此我認為，與其說毛利率會加速上升，我認為它們會維持在那個區間——我們本季做到 69%。我的意思是，在我們把這些再平衡得更到位之前，毛利率可能會維持在高 60% 到低 70% 的區間。

But we have that opportunity to do so and before we have to really accelerate revenue or inventory production again. But the organization, along with that, has taken out a significant amount of costs and really reorganized the way they are doing ordering and planning, and I think that we have an ability to see efficiencies through this time that may not negatively impact margins going forward.

但我們確實有這樣的機會，而且在我們必須再次真正加速營收或庫存生產之前。同時，組織也已經大幅削減成本，並且真正重新調整了他們下單與規劃的方式；我認為我們有能力在這段期間看到效率提升，而這些提升未來不一定會對毛利率造成負面影響。

(Operator Instructions)

(接線員指示)

Sean Lee.

Sean Lee。

I just have a couple on the commercial side. With regards to Germany, you mentioned that you're seeing good signs of a turnaround and expect to growing the sales force there again. So I was wondering when do you expect the overall German market to inflect back to growth? And what's the expected cost of the sales expansion that you're looking at?

我在商業端有幾個問題。關於德國，你提到你們看到轉機的良好跡象，並預期會再次擴增當地的銷售團隊。所以我想請問，你們預期整體德國市場何時會回到成長拐點？以及你們規劃的銷售擴編，預期成本是多少？

Yes. I think that what we saw in the first-quarter was very encouraging progress across the German organization. And again, we nearly matched sales from a year ago with smaller, more focused sales force. The way that we have sourced our headcount in Germany and in many other countries, is that it is typically a lower variable. I mean, a lower fixed salary, coupled with an opportunity to earn quite a lot of money on the upside with a higher variable component.

是的。我認為我們在第一季看到德國團隊各方面都出現非常令人鼓舞的進展。而且再次強調，我們在更小、更聚焦的銷售團隊下，銷售額幾乎追平去年同期。我們在德國以及許多其他國家的人力配置方式，通常是較低的變動——也就是說，較低的固定薪資，再搭配較高的變動薪酬比例，讓他們在上行時有機會賺到相當可觀的收入。

In fact, many -- most medical device companies do this across the board. But it's a way to be able to control that initial spend as the sales team gets up to speed and becomes productive. So we believe that out of the gate, those sales reps will be able to pay for themselves, with just the initial business that they're doing. And as they become much more productive, they'll help to contribute to the overall growth of the organization. Germany is an 87 million population country, it's huge. And it has many hospitals around 1,900 hospitals within the country, and it's a lot of work for a small sales team to cover.

事實上，許多——大多數醫療器材公司普遍都是這樣做。但這是一種在銷售團隊逐步上手並提升產能的過程中，能夠控制初期支出的方式。因此我們相信，這些業務代表一開始就能靠他們帶來的初始業務量把自己「養起來」。而當他們變得更具生產力時，也將有助於推動整體組織的成長。德國人口 8,700 萬，非常大。而且全國約有 1,900 家醫院；對一個小型銷售團隊而言，要覆蓋這麼多醫院是非常大量的工作。

And so I think we truly believe that there's a lot of opportunity as we begin to reshape our commercial organization in Germany to really just get beyond treading water and staying even to actually returning to growth. But I think that's what a lot of this operational efficiency, driving performance by metrics and strong leadership is all about. And that's what we're encouraged by the recent progress that we've made.

因此我認為，我們確實相信，當我們開始重塑德國的商業組織時，將有很大的機會，讓我們不只是勉強維持、持平，而是實際回到成長。但我認為，這正是許多營運效率提升、以指標驅動績效以及強而有力的領導所要達成的目標。而這也是我們對近期所取得的進展感到鼓舞的原因。

Great. My second question is on the -- well, the direct sales outside Germany seems to grow really well, with 13% this quarter. So maybe you could elaborate a bit on what's the primary drivers behind this growth? And why it's so different from what we've seen in Germany, at least in the previous quarters?

很好。我的第二個問題是——嗯，德國以外的直銷業務本季成長似乎非常強勁，達到 13%。所以也許你可以多談一點，這個成長背後的主要驅動因素是什麼？以及為什麼它和我們在德國看到的情況差異這麼大，至少在前幾季是如此？

Well, I think that the -- first of all, I think that we have a lot of avid users in our direct territories, right? So historically, it's been Germany, Austria, Switzerland, but it has continued to progress to other countries like Poland and Netherlands and countries in the UK, such that we consider all the time about looking to increase the number of direct territories that we're actually selling into. But I think that they benefit from growing on a smaller base of revenue, but I do believe that it's really based upon the leadership as well as the individual team effort in individual countries that is driving that growth.

嗯，我認為——首先，我認為我們在直營區域有很多忠實使用者，對吧？所以歷史上主要是德國、奧地利、瑞士，但也持續拓展到其他國家，例如波蘭、荷蘭，以及英國的一些地區；因此我們一直都在考慮是否要增加我們實際進行直銷的直營區域數量。但我認為，他們受益於在較小的營收基礎上成長；不過我也相信，這主要是由領導力以及各國團隊的個別努力所驅動的成長。

And they're just very scrappy about how they approach market development. They are very hands on, very in touch with their customers, looking to exploit -- not exploit, but actually really teach all the different strategies and all the different applications that are well known to more developed countries like Germany, Austria and Switzerland. And so I think the teams are doing well, and we continue to work to try to improve operational efficiency even in these teams, and we think that will also have paid dividends in the future.

而且他們在市場開發的做法上非常靈活、很拚。他們非常親力親為，與客戶保持高度連結，並且希望去發掘——不是「利用」，而是實際去教導各種不同的策略與各種不同的應用；這些在像德國、奧地利、瑞士這些更成熟的國家已經相當普及。因此我認為這些團隊做得很好，我們也持續努力，即使在這些團隊中也要提升營運效率，而我們認為這在未來也會帶來回報。

My last question is on the Middle East. So you mentioned that there were $0.5 million of delayed distributor orders. I was wondering whether you feel that that's still recoverable either in Q2 or later this year? And do you expect to see a continued impact in the region as well?

我最後一個問題是關於中東。你提到有 50 萬美元的經銷商訂單延遲。我想請問，你是否認為這些訂單仍有機會在第二季或今年稍晚追回？以及你是否預期該地區仍會持續受到影響？

Yes, Sean, I think the answer to that is yes. I think we've had orders that were -- we had orders that were submitted and needed to be canceled at the last minute and orders under development that did not come in during the month of March. Those are all reflective of the development work our team is doing in the Middle East to get those, in some cases, new distributors and in others existing distributors, up and running and focused on the business. We've seen a lot of increased activity at conferences across the Middle East, a lot of excitement of physicians across the Middle East in these conferences.

是的，Sean，我認為答案是肯定的。我認為我們有一些訂單——我們有一些已提交的訂單在最後一刻必須取消，還有一些正在推進中的訂單在 3 月並未進來。這些都反映了我們團隊在中東所做的開發工作，讓那些在某些情況下是新經銷商、在其他情況下是既有經銷商，能夠上線運作並把重心放在業務上。我們也看到中東各地的會議活動明顯增加，在這些會議上，中東的醫師群體也展現出很高的熱情。

And there's just a growing amount of interest in this region, and we are confident that although I don't expect a snap back when things settle down. But over the months, following stability in the Middle East. I think those distributors are going to be ready to move and take inventory and start distributing again.

而且這個地區的興趣正在持續升溫；我們有信心，雖然我不預期在局勢穩定後會立刻快速反彈。但在中東恢復穩定之後的幾個月內，我認為這些經銷商將會準備好採取行動、補進庫存，並再次開始進行分銷。

There are no further questions at this time. I will now turn the call back over to Phil Chan for the closing remarks.

目前沒有其他問題。我現在把電話交回給 Phil Chan 作結語。

Well, again, everyone, we appreciate your support of the company and look forward to updating you on our continued progress throughout the year. We look forward to giving you an update, hopefully, on the regulatory process in the near future. Thank you again. And if you have any questions, please feel free to reach out to ir@cytosorbents.com, and we'll try to answer those questions as best we can. Thank you so much. Have a good night.

那麼，再次感謝各位對公司的支持，我們也期待在今年持續向各位更新我們的進展。我們也希望在不久的將來，能夠就法規審查流程提供最新進度。再次感謝。如果你們有任何問題，歡迎隨時寄信至 ir@cytosorbents.com，我們會盡力回答。非常感謝。祝各位晚安。

Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.

各位女士、先生，今天的電話會議到此結束。感謝各位參與。您現在可以掛線。