Cytosorbents Corp (CTSO) 2023 Q2 法說會逐字稿

Good afternoon and welcome to the CytoSorbents Second Quarter 2023 Financial and Operating Results Conference Call. (Operator Instructions) Please be advised that the call will be recorded at the company's request.

下午好，歡迎參加 CytoSorbents 2023 年第二季財務與營運業績電話會議。 （操作員說明）請注意，根據公司的要求，將對通話進行錄音。

At this time, I'd like to turn the call over to our moderator, Taylor Devlin. Please go ahead, Taylor.

現在，我想將電話轉給我們的主持人泰勒·德夫林 (Taylor Devlin)。請繼續，泰勒。

Thank you and good afternoon. Welcome to CytoSorbents Second Quarter 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, Interim Chief Financial Officer; Dr. Efthymios Deliargyris, Chief Medical Officer; Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of CytoSorbents Europe GmbH; Christopher Cramer, Senior Vice President of Business Development; Dr. Irina Kulinets, Senior Vice President of Regulatory.

謝謝你，下午好。歡迎參加 CytoSorbents 2023 年第二季財務與營運績效電話會議。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 (Kathleen Bloch)，臨時財務長； Efthymios Deliargyris 博士，首席醫療官； Christian Steiner 博士，CytoSorbents Europe GmbH 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； Irina Kulinets 博士，監管資深副總裁。

Before I turn the call 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. Therefore, the company claims protection under safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

在我將電話轉給陳博士之前，我想提醒聽眾，在電話會議期間，管理層準備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。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保護。

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. Any projections as to the company's future performance represented by management include estimates today as of August 1, 2023, and we assume no obligation to update these projections in the future as market conditions change.

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。管理階層對公司未來業績的任何預測均包括截至 2023 年 8 月 1 日的預測，我們不承擔未來隨著市場條件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 second quarter of 2023 by Dr. Chan and Ms. Bloch. Following that presentation, we will open 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，我們將由陳博士和布洛赫女士進行概述，介紹 2023 年第二季的營運和財務亮點。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's my pleasure to turn the call over to Dr. Phil Chan.

現在我很高興將電話轉給 Phil Chan 博士。

Thank you very much, Taylor, and good afternoon. Today, I have the pleasure of being able to update you on our most recent operational progress. We recently announced that the pivotal STAR-T trial completed enrollment ahead of internal projections with strong performance amongst our 30 clinical centers in the United States and Canada. This followed the second independent data and safety monitoring board evaluation in June on unblinded safety data on 80 patients, where the DSMB recommended completion of the trial without modification.

非常感謝你，泰勒，下午好。今天，我很高興能夠向您介紹我們最新的營運進度。我們最近宣布，關鍵的 STAR-T 試驗提前於內部預測完成了入組，在我們位於美國和加拿大的 30 個臨床中心中表現強勁。此前，獨立數據和安全監測委員會於 6 月對 80 名患者的非盲安全數據進行了第二次評估，DSMB 建議在不進行修改的情況下完成試驗。

In the second quarter of 2023, we achieved total revenue of $9.4 million, including product sales of $8.1 million versus $7.3 million in product sales a year ago, representing the third consecutive quarter of sequential product sales growth. Product gross margins grew 700 basis points to 74% from 67% a year ago. And we have now exceeded 212,000 cumulative human treatments delivered across 75 countries worldwide.

2023 年第二季度，我們實現了 940 萬美元的總收入，其中產品銷售額為 810 萬美元，而一年前的產品銷售額為 730 萬美元，代表產品銷售額連續第三個季度增長。產品毛利率從一年前的 67% 增加 700 個基點至 74%。目前，我們在全球 75 個國家累積提供了超過 212,000 次人類治療。

We announced the appointment of Alex D'Amico as new Chief Financial Officer to start next week, August 7, 2023. Alex brings 20 years of broad finance, SEC reporting, M&A, fundraising and accounting experience to the company. And our outgoing Chief Financial Officer, Kathy Bloch, will stay on as a consultant and help to manage the transition.

我們宣布任命Alex D'Amico 為新任財務官，任期將於下週（2023 年8 月7 日）開始。Alex 為該公司帶來了20 年的廣泛財務、SEC 報告、併購、籌款和會計經驗。我們即將離任的財務長凱西·布洛赫 (Kathy Bloch) 將繼續擔任顧問，並協助管理轉型。

We also introduced Michael Bator as the new Chairman of the Board at the Annual Meeting in June. Michael has been a Board Director since 2015 and currently serves as a founder and partner of Court's Advisory Group, the Capital Markets Investment Bank. Michael was also the former Managing Director of Healthcare Research at Jennison Associates, a very large family of funds with more than $175 billion in assets under management.

我們也在六月的年會上介紹了 Michael Bator 擔任新任董事會主席。 Michael 自 2015 年起擔任董事會董事，目前擔任資本市場投資銀行法院諮詢小組的創辦人和合夥人。 Michael 也曾擔任 Jennison Associates 醫療保健研究部董事總經理，該基金是一個規模龐大的基金家族，管理著超過 1,750 億美元的資產。

Last but not least, we announced the theranostic collaboration with Humedics. Humedics is the manufacturer of the EU-approved LiMAx liver function test that is used in liver patients to evaluate the functioning of the liver. We announced a 1-year joint marketing agreement, where their sales force and ours in respective territories will cross-market CytoSorb as a superior extracorporal liver support technology and LiMAx as a unique liver function test for the treatment of liver disease.

最後但並非最不重要的一點是，我們宣布與 Humedics 進行治療診斷合作。 Humedics 是歐盟批准的 LiMAx 肝功能測試的製造商，該測試用於肝臟患者評估肝臟功能。我們宣布了一項為期1 年的聯合行銷協議，他們的銷售人員和我們在各自地區的銷售人員將交叉銷售CytoSorb 作為一種卓越的體外肝臟支援技術，以及LiMAx 作為一種獨特的肝功能測試，用於治療肝病。

As we've discussed previously, we are focused on 3 major objectives for 2023. The first is opening the U.S. and Canadian markets with DrugSorb-ATR. The second is a return to sales growth of CytoSorb. And the third is to reduce our cash burn and to have tight control over expenses.

正如我們之前討論的，我們在 2023 年重點關注 3 個主要目標。第一個目標是透過 DrugSorb-ATR 打開美國和加拿大市場。第二個是 CytoSorb 的銷售成長恢復。第三是減少現金消耗並嚴格控制支出。

In terms of opening the U.S. and Canadian markets with DrugSorb-ATR, I would like to note again that DrugSorb-ATR and STAR-T, which stands for the safe and timely Antithromobotic Removal of Ticagrelor trial, remains the core focus of our clinical efforts and the vehicle expected to open the U.S. and Canadian markets. This leverages 2 FDA breakthrough device designation for DrugSorb-ATR to remove blood-thinning medications in patients undergoing cardiac surgery.

在DrugSorb-ATR打開美國和加拿大市場方面，我想再次指出，DrugSorb-ATR和代表安全及時的替格瑞洛抗血栓清除試驗的STAR-T仍然是我們臨床工作的核心重點該車預計將打開美國和加拿大市場。這利用了 FDA 對 DrugSorb-ATR 的兩項突破性設備指定，以去除接受心臟手術的患者的血液稀釋藥物。

One of these breakthrough device designations is for the removal of Brilinta, commonly known as Ticagrelor. And also the second one is for the direct oral Anticoagulants, of which Eliquis and Xarelto are the leading ones in that category.

這些突破性的設備名稱之一是用於去除 Brilinta（通常稱為替格瑞洛）。第二個是直接口服抗凝血藥，其中 Eliquis 和 Xarelto 是該類別中的領先藥物。

In addition following independent Data Safety Monitoring Board review of the first 80 patients' safety data in the STAR-T trial and recommendation to continue the trial without modifications, we are pleased to announce that STAR-T enrollment has now completed. This helps to validate the decision to forgo the interim analysis at 80 patients that we discussed on the last earnings call. And we expect that the trial to complete imminently following the last 30-day patient follow-up. We believe this sets us up for near-term milestones that are rapidly approaching, which is why I have this picture of a mirror that says objects in the mirror are closer than they appear.

此外，在獨立資料安全監測委員會對 STAR-T 試驗中前 80 名患者的安全資料進行審查並建議不加修改地繼續試驗後，我們很高興地宣布 STAR-T 入組現已完成。這有助於驗證我們在上次財報電話會議上討論的放棄對 80 名患者進行中期分析的決定。我們預計試驗將在最後 30 天的患者追蹤後立即完成。我們相信，這為我們快速接近的近期里程碑奠定了基礎，這就是為什麼我有這張鏡子的圖片，上面寫著鏡子中的物體比它們看起來更近。

First, we expect to get the database lock in the next several months, followed by statistical data analysis. This should hopefully lead to top line data targeted by year-end, and if positive, regulatory submission to the U.S. FDA and Health Canada to follow.

首先，我們預計在未來幾個月內獲得資料庫鎖定，然後進行統計數據分析。這預計在年底前產生頂線數據，如果積極的話，將隨後向美國 FDA 和加拿大衛生部提交監管報告。

We also expect to present data at a major cardiovascular conference next year. And pending visibility, we begin -- we plan to begin executing on our precommercialization strategy and begin building a direct sales and marketing infrastructure in 2024.

我們也預計在明年的重要心血管會議上公佈數據。在可見性之前，我們開始 - 我們計劃開始執行我們的預商業化策略，並在 2024 年開始建立直銷和行銷基礎設施。

One thing that we really haven't discussed extensively in the past are the dynamics that may actually help expand Ticagrelor market share in the United States and Canada, but particularly in the United States. And more Ticagrelor use means potentially more DrugSorb-ATR use should we get approved. As we've discussed in the past, patients with acute coronary syndrome who come into the emergency room with symptoms of having a heart attack often gets dual Antiplatelet therapy. This consists of aspirin plus one of the P2Y12 platelet inhibitors, such as Brilinta or Ticagrelor; Plavix or clopidogrel; or Effient, also known as prasugrel.

我們過去確實沒有廣泛討論的一件事是，實際上可能有助於擴大替格瑞洛在美國和加拿大（尤其是美國）市場份額的動態。如果我們獲得批准，更多的替格瑞洛使用意味著可能會更多地使用 DrugSorb-ATR。正如我們過去所討論的，患有急性冠狀動脈綜合症的患者因心臟病發作的症狀而進入急診室，通常會接受雙重抗血小板治療。它由阿斯匹靈加上一種 P2Y12 血小板抑制劑組成，例如 Brilinta 或 Ticagrelor；波立維或氯吡格雷；或 Effient，也稱為普拉格雷。

Brilinta has superior antithrombotic efficacy to Plavix, but Plavix is generic and cheap, and Brilinta today is still a branded drug. However, this is expected to change as Brilinta will go generic in 2024 to become just generic Ticagrelor with multiple competitors with tentatively approved abbreviated NDAs that have already been approved by the FDA. The price of Ticagrelor is expected to fall, potentially enabling market share gains against clopidogrel and the more expensive branded Effient.

Brilinta 的抗血栓功效優於波立維 (Plavix)，但波立維 (Plavix) 是仿製藥且價格低廉，而如今的 Brilinta 仍是品牌藥。然而，這種情況預計會發生變化，因為 Brilinta 將在 2024 年進行仿製藥，成為仿製藥替格瑞洛（Ticagrelor），而多個競爭對手都已獲得 FDA 批准的暫定批准的簡化 NDA。替格瑞洛的價格預計將下降，從而有可能提高其相對於氯吡格雷和更昂貴的品牌 Effient 的市場份額。

A recent publication in the well-respected journal, JAMA Network Open, highlights U.S. prescribing physician preference for Ticagrelor versus other Antiplatelet agents following acute coronary syndrome and percutaneous coronary intervention, in other words, for example, stent placement in more than 62,000 patients that were studied between 2010 to 2019.

最近在備受推崇的雜誌《JAMA Network Open》上發表的一篇文章強調了美國醫生在急性冠脈綜合徵和經皮冠狀動脈介入治療後（換句話說，例如在超過62,000 名患者接受支架置入治療後）對替格瑞洛的處方偏好，而不是其他抗血小板藥物。2010年至2019年學習。

And what you can see in the graph in the lower right is that during that period of 2010 to 2019 that Ticagrelor has steadily gained in prescribing preference for physicians following acute coronary syndrome and PCI to the point we're now, or at least in 2019, 60.4% of patients who were intervened upon in the [cath] Lab got Ticagrelor or Brilinta, while the rate of Plavix prescription have been going down to only about 30% in 2019. And prasugrel is a distant third at 10% of prescriptions, leading the authors to conclude that "Ticagrelor has emerged as the most commonly prescribed P2Y12 platelet inhibitor."

從右下圖可以看到，在 2010 年至 2019 年期間，替格瑞洛在急性冠狀動脈綜合症和 PCI 治療後的醫生處方偏好中穩步上升，達到我們現在的水平，或者至少在 2019 年，在[cath] 實驗室接受干預的患者中有60.4% 服用了替格瑞洛或Brilinta，而2019 年波立維處方率已下降至僅30% 左右。普拉格雷遠遠落後於第三位，佔處方的10%，導致作者得出結論：“替格瑞洛已成為最常用的 P2Y12 血小板抑制劑。”

In addition, the approval of DrugSorb-ATR would make Ticagrelor the only one of these Antiplatelet drugs to be reversible during CABG surgery, a potentially powerful marketing advantage to take market share. One can imagine given that 5% to 10% of patients are not eligible for stent placement and wind up in surgery that being able to reverse the drug used in dual Antiplatelet therapy would be an extremely valuable marketing advantage that we could confer to Ticagrelor. And we believe that this will come to pass and be true. Ultimately, this sets us up for an initial market in the United States for removal of Brilinta in cardiac surgery patients of approximately 250 million. And if you add Canada, this increases the total addressable market to roughly 300 million to 350 million in additional share against Plavix and Effient. The numbers of patients on Brilinta or Ticagrelor in the future could rise to give us an opportunity of about a $500 million total addressable market.

此外，DrugSorb-ATR 的批准將使替卡格雷成為唯一一種在 CABG 手術期間可逆的抗血小板藥物，這是奪取市場份額的潛在強大行銷優勢。可以想像，鑑於5% 至10% 的患者不符合支架置入條件並最終接受手術，能夠逆轉雙重抗血小板治療中使用的藥物將是我們可以賦予替格瑞洛的一項極其有價值的營銷優勢。我們相信這將會成為現實。最終，這為我們在美國建立了一個初步市場，用於為大約 2.5 億個心臟手術患者切除 Brilinta。如果加上加拿大，這將使整個潛在市場增加到約 3 億至 3.5 億，相對於 Plavix 和 Effient 的額外份額。未來使用 Brilinta 或 Ticagrelor 的患者數量可能會增加，為我們帶來約 5 億美元總目標市場的機會。

As we told you in the past, once STAR-T completed, we're looking to resume the STAR-D trial, which is looking at the removal of the direct oral Anticoagulants, the Factor Xa inhibitors, Eliquis and Xarelto. And if we are able to add on that indication, this could double our total addressable market to $1 billion. And if we can now open it up from not just cardiac surgery but to all kinds of surgeries and also potentially being able to be used in the emergency room, we estimate that, that could, again, double the total addressable market here in the United States.

正如我們過去告訴過您的，一旦 STAR-T 完成，我們將尋求恢復 STAR-D 試驗，該試驗的目的是取消直接口服抗凝血劑、Xa 因子抑制劑、Eliquis 和 Xarelto。如果我們能夠添加這項指標，我們的潛在市場總額可能會翻倍，達到 10 億美元。如果我們現在不僅可以將其應用於心臟手術，還可以擴展到所有類型的手術，並且還可能在急診室中使用，我們估計，這可能會再次使美國的總潛在市場翻一番狀態。

So a second major goal for the company is return to sales growth for CytoSorb. Again, this has been the third consecutive quarter of sequential product sales growth with 10% quarterly product sales growth year-over-year in the second quarter. We're seeing continued gradual recovery of hospital markets post COVID with continued strong customer engagement and enthusiastic response to our new data and marketing strategies.

因此，該公司的第二個主要目標是恢復 CytoSorb 的銷售成長。這也是產品銷售連續第三個季度實現環比成長，第二季產品銷售年增 10%。我們看到，新冠疫情過後，醫院市場持續逐步復甦，客戶參與度持續強勁，對我們的新數據和行銷策略反應熱烈。

Our product gross margins rose 700 basis points to 74%, reflecting volume production from our new Princeton manufacturing facility, a trend consistent with prior guidance of returning to 75% to 80% profit quarterly base year.

我們的產品毛利率上升了 700 個基點，達到 74%，反映出我們新的普林斯頓製造工廠的批量生產，這一趨勢與之前季度基準年利潤恢復到 75% 到 80% 的指導一致。

The following messages: one that we need to be able to treat the right patient with the right timing and the right dose. And we also need to hit hard and hit early. And this incorporates our evolving understanding of how best to treat patients with CytoSorb. In particular, when CytoSorb is used early and aggressively and documented hyperinflamed patients, we have seen some outstanding results. This includes the recently published CTC therapy registry result in the Journal Critical Care, detailing the clinical outcomes in 100 critically ill COVID-19 patients with severe inflammation and refractory lung failure using CytoSorb with ECMO to achieve enhanced lung rest.

以下資訊：我們需要能夠在正確的時間和正確的劑量下治療正確的患者。我們還需要重拳出擊、儘早出擊。這體現了我們對如何最好地治療 CytoSorb 患者的不斷深入的理解。特別是，當 CytoSorb 早期積極使用並記錄過度發炎患者時，我們看到了一些出色的結果。這包括最近在《重症護理雜誌》上發表的 CTC 治療登記結果，詳細介紹了 100 名患有嚴重發炎和難治性肺衰竭的重症 COVID-19 患者使用 CytoSorb 結合 ECMO 來增強肺部休息的臨床結果。

Overall, 90-day survival was high at 74%. And in the post hoc analysis, patients who were treated before the median treatment time of 87 hours had even higher survival at 82% compared to 66% survival in patients treated after 87 hours. In addition, those treated in the early group had significantly shorter median duration times on mechanical ventilation, ECMO on the -- in the blue lower left-hand graph, mechanical ventilation in red and ICU stay in green.

整體而言，90 天存活率高達 74%。在事後分析中，在中位數治療時間 87 小時之前接受治療的患者的生存率甚至更高，為 82%，而 87 小時後接受治療的患者的生存率為 66%。此外，早期組接受治療的患者機械通氣、ECMO 的中位數持續時間顯著縮短——在藍色左下角圖中，機械通氣為紅色，ICU 為綠色。

Overall, our results compare favorably to the approximately 50% survival reported by ELSO, or the Extracorporeal Life Support organization, and their COVID-19 registry survival data, where they looked at ECMO use alone in this population. Our data supports the strategy of early combined usage mode to treat severe ARDS, or acute respiratory distress syndrome, and refractory lung failure and is a prime example of our " hit early, hit hard " treatment philosophy.

總體而言，我們的結果與 ELSO（或體外生命支持組織）報告的約 50% 的生存率及其 COVID-19 註冊生存數據相比，他們在該人群中單獨使用 ECMO 進行了研究。我們的數據支持早期合併使用模式治療嚴重 ARDS 或急性呼吸窘迫症候群和難治性肺衰竭的策略，是我們「儘早打擊、大力打擊」治療概念的一個典型例子。

To this end, our current company-sponsored trials, such as the PROCYSS refractory septic shock randomized controlled trial and the International COSMOS Critical Illness Registry, incorporate our evolving understanding of how to achieve better and more consistent results with CytoSorb. We've also been working to drive earlier usage of CytoSorb in the appropriate patients through a number of different ways, including, for example, pursuing a theranostic strategy, in other words, using a diagnostic test to guide patient selection and timing of CytoSorb therapy as we're doing in our collaboration with Humedics in the field of liver disease; or selling a simple-to-use of multilocal hemoperfusion machine as we're doing with the PureADJUST platform from Nikkiso that can run CytoSorb without needing to wait for patients to develop kidney failure and go on to dialysis.

為此，我們目前由公司贊助的試驗，例如PROCYSS 難治性感染性休克隨機對照試驗和國際COSMOS 危重疾病登記處，融入了我們對如何使用CytoSorb 獲得更好、更一致的結果的不斷發展的理解。我們也一直致力於透過多種不同方式推動 CytoSorb 在適當患者中的早期使用，包括，例如，追求治療診斷策略，換句話說，使用診斷測試來指導患者選擇 CytoSorb 治療和時機正如我們與Humedics 在肝病領域的合作所做的那樣；或者銷售一種易於使用的多局部血液灌流機，就像我們正在使用 Nikkiso 的 PureADJUST 平台所做的那樣，該平台可以運行 CytoSorb，而無需等待患者出現腎衰竭並繼續進行透析。

So with that, I'd like to turn it over to Kathy to now cover financial highlights for the quarter. Kathy?

因此，我想將其交給凱西，現在介紹本季的財務亮點。凱西？

Thank you, Phil, and greetings to everyone on today's call. Let's start with our first slide on second quarter revenues. For the quarter ended June 30, 2023, total revenue, which includes product sales and grant revenue, was $9.4 million compared to total revenue of $8.5 million in the second quarter of 2022, which is an increase of approximately 11%. Product sales for the second quarter 2023 were $8.1 million compared to approximately $7.3 million for the second quarter of the prior year.

謝謝菲爾，並向參加今天電話會議的所有人致以問候。讓我們從第二季營收的第一張投影片開始。截至 2023 年 6 月 30 日的季度，總收入（包括產品銷售和贈款收入）為 940 萬美元，而 2022 年第二季度的總收入為 850 萬美元，成長約 11%。 2023 年第二季的產品銷售額為 810 萬美元，而去年第二季的產品銷售額約為 730 萬美元。

And our second quarter 2023 product gross margins were 74% compared to 67% for the second quarter of 2022 and 68% in the first quarter of 2023. And this predicted improvement in gross margins is expected to continue throughout the year as we fully complete all the start-up activities associated with our new manufacturing plant and continue to ramp up production.

我們2023 年第二季的產品毛利率為74%，而2022 年第二季為67%，2023 年第一季為68%。隨著我們全面完成所有目標，毛利率預計的改善預計將在全年持續。與我們的新製造工廠相關的啟動活動並繼續提高產量。

Our second quarter grant revenue was $1.3 million compared to $1.2 million in the same quarter of the prior year.

我們第二季的補助收入為 130 萬美元，而去年同期為 120 萬美元。

Next slide, please. For the 6 months ended June 30, 2023, total revenue was $18.9 million, an approximately 10% increase over the $17.2 million in total revenue for the same period of 2022. First half 2023 product sales were $16 million compared with $15.3 million in the same period of 2022. And grant revenue was $2.9 million in the first half of 2023 compared to $1.9 million in the prior year.

請下一張投影片。截至2023 年6 月30 日的6 個月，總收入為1,890 萬美元，比2022 年同期的總收入1,720 萬美元增長約10%。2023 年上半年產品銷售額為1,600 萬美元，而去年同期為1,530 萬美元。2022 年 上半年的補助收入為 290 萬美元，而前一年為 190 萬美元。

Next slide, please. So this next chart depicts our trailing 12-month product sales, and it's broken down into COVID-19-related and core non-COVID-19-related product sales. Our core product sales of $30.1 million in the trailing 12-month period ended June 30, 2023, they're just slightly behind core product sales of $30.7 million in the trailing 12-month period ended June 30, 2022. And this was due to the difficult market conditions, including a shortage of health care workers, fewer hospital beds, less surgical procedures as well as other factors that we have discussed in prior earnings calls.

請下一張投影片。因此，下一張圖表描述了我們過去 12 個月的產品銷售情況，並將其細分為與 COVID-19 相關的產品銷售情況和與 COVID-19 相關的核心產品銷售情況。截至2023 年6 月30 日的過去12 個月期間，我們的核心產品銷售額為3,010 萬美元，僅略低於截至2022 年6 月30 日的過去12 個月期間的核心產品銷售額3,070 萬美元。這是由於困難的市場條件，包括醫護人員短缺、病床減少、外科手術減少以及我們在之前的財報電話會議中討論過的其他因素。

As Phil mentioned, we are continuing to see improvements in the marketplace, including our sales team's ability to better access health care workers in the hospital and a return to face-to-face discussions with physicians in the market.

正如菲爾所提到的，我們不斷看到市場的改善，包括我們的銷售團隊能夠更好地接觸醫院的醫護人員，以及恢復與市場上的醫生進行面對面的討論。

Next slide, please. And this slide shows our quarterly product sales broken down again by COVID-19-related and non-COVID-19-related core product sales. And as you can see, over the past 5 quarters, there have been no COVID-19-related sales. The most recent 3 quarters have demonstrated sequential consecutive quarter-over-quarter growth in product sales with $8.1 million in quarterly sales, Q2 2023 represents the highest quarter of core non-COVID-19-related sales since the COVID-19 pandemic was contained.

請下一張投影片。這張投影片顯示了我們的季度產品銷售額再次按 COVID-19 相關和非 COVID-19 相關核心產品銷售額細分。正如您所看到的，在過去 5 個季度中，沒有出現與 COVID-19 相關的銷售。最近 3 個季度的產品銷售額連續環比增長，季度銷售額為 810 萬美元，2023 年第二季度是自 COVID-19 大流行得到遏制以來核心非 COVID-19 相關銷售額最高的季度。

Next slide, please. And I'd like to wrap up my remarks today with some comments about our cash position. As of June 30, 2023, we had approximately $14.8 million in cash and cash equivalents, which includes $1.7 million of restricted cash. This includes $5 million of loan proceeds received from our debt facility in December 2022.

請下一張投影片。我想用一些關於我們現金狀況的評論來結束我今天的演講。截至 2023 年 6 月 30 日，我們擁有約 1,480 萬美元的現金和現金等價物，其中包括 170 萬美元的限制性現金。這包括 2022 年 12 月從我們的債務融資中收到的 500 萬美元貸款收益。

Now one of our key objectives for 2023 has been to reduce our cash burn and maintain tight control over expenditures, and I'd like to elaborate on our progress on this. Over the past year, we took strong actions to reduce our quarterly cash burn such that our quarterly cash burn over the first half of 2023 averaged approximately $4.5 million, which is down significantly from the average quarterly cash burn in the first half of 2022, which was approximately $11 million.

現在，我們 2023 年的主要目標之一是減少現金消耗並保持對支出的嚴格控制，我想詳細介紹我們在這方面的進展。在過去的一年裡，我們採取了強有力的行動來減少季度現金消耗，使得 2023 年上半年的季度現金消耗平均約為 450 萬美元，比 2022 年上半年的平均季度現金消耗大幅下降。約為1100萬美元。

We continue to maintain tight control over cash guided by a strict 2023 operating budget, prioritizing spend in key programs and pipeline products. Our spending is fully aligned with our strategic priorities, in particular the completion of our STAR-T clinical trial designed to obtain U.S. FDA marketing approval.

我們繼續在嚴格的 2023 年營運預算的指導下保持對現金的嚴格控制，優先考慮關鍵項目和管道產品的支出。我們的支出與我們的策略重點完全一致，特別是完成我們旨在獲得美國 FDA 行銷批准的 STAR-T 臨床試驗。

So that will conclude my remarks for today. And at this time, I would like to turn the call back to Phil for concluding comments. Phil?

我今天的發言就到此結束。此時，我想將電話轉回菲爾，以徵求結論意見。菲爾？

Yes. So thank you very much, Kathy. I apologize for that. Today, CytoSorb drives our growth. CytoSorb forms the foundation of our company with an EU-approved product that is sold around the world that has generated approximately $200 million in sales since launching more than 200,000 human treatments around the world. It is a high-margin razor-blade business model with industry top-tier 80-plus percent blended product gross margins. And it has had strong validation by customers, partners and government agencies with current sales that supports near breakeven, less clinical trial costs, which we believe helps to derisk the company and the investment opportunity.

是的。非常感謝你，凱西。我對此表示歉意。如今，CytoSorb 推動著我們的發展。 CytoSorb 是我們公司的基礎，該產品已獲得歐盟批准，銷往世界各地，自在全球推出超過 200,000 種人類治療方法以來，已產生約 2 億美元的銷售額。這是一種高利潤的刮鬍刀片商業模式，混合產品毛利率高達 80% 以上，處於業界領先水準。它得到了客戶、合作夥伴和政府機構的強烈認可，目前的銷售支持接近收支平衡，臨床試驗成本較低，我們相信這有助於降低公司和投資機會的風險。

We believe CytoSorb represents the fuel for strong future growth anticipated growth, targeting 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. And we believe this gives CytoSorbents the potential upside of a biotechnology company with a lower-risk profile of a high-margin medical device company with sales.

我們相信 CytoSorb 代表了未來強勁成長和預期成長的動力，目標是全球 200 億至 300 億美元的潛在市場，主要滿足重症監護、心臟手術以及肝腎疾病等主要未滿足的醫療需求。我們相信，這為 CytoSorbents 提供了作為一家生技公司的潛在優勢，同時也是一家高利潤醫療器材公司的銷售風險較低的公司。

But soon, we believe that the story could change with CytoSorb and DrugSorb-ATR representing dual growth engines for the company. We are raising to the finish of STAR-T, where we are rapidly nearing the completion of the study expected imminently with top line data expected later this year. For STAR-T to be successful and DrugSorb-ATR achieves U.S. FDA and Health Canada regulatory approval, we intend to commercialize DrugSorb-ATR in both the U.S. and Canada, a potentially major second engine of growth working in tandem with CytoSorb to drive sales.

但很快，我們相信情況可能會發生變化，CytoSorb 和 DrugSorb-ATR 代表了該公司的雙重成長引擎。我們的 STAR-T 專案正在接近尾聲，我們正在迅速接近完成預計將在今年稍後獲得頂線數據的研究。為了讓 STAR-T 成功並且 DrugSorb-ATR 獲得美國 FDA 和加拿大衛生部的監管批准，我們打算在美國和加拿大將 DrugSorb-ATR 商業化，這是與 CytoSorb 共同推動銷售的潛在主要第二成長引擎。

DrugSorb may open an expected initial U.S. and Canadian total addressable market of $300 million to $350 million for Brilinta alone, which could expand should Brilinta go generic as Ticagrelor, where we expect significant penetration given that major unmet medical need indicated by our FDA breakthrough device designation. If successful, this could transform CytoSorbents into a dual U.S. and international growth company that current and prospective institutional and retail shareholders are excited about and have been waiting for and that can create potentially significant value.

DrugSorb 可能會在美國和加拿大為Brilinta 帶來3 億至3.5 億美元的初始潛在市場，如果Brilinta 成為仿製藥替格瑞洛，該市場可能會擴大，鑑於FDA 突破性器械指定表明主要未滿足的醫療需求，我們預期該市場將出現顯著滲透。如果成功，這可能會將 CytoSorbents 轉變為一家美國和國際雙重成長型公司，當前和潛在的機構和零售股東對此感到興奮並一直在等待，並且可以創造潛在的巨大價值。

With that, the formal remarks, operator, please open the Q&A session.

至此，正式發言，操作員，請開始問答環節。

(Operator Instructions) And our first question will come from Joshua Jennings of TD Cowen.

（操作員說明）我們的第一個問題將來自 TD Cowen 的 Joshua Jennings。

Congratulations on completing the enrollment for STAR-T. And Kathy, congratulations on your retirement. Was hoping to just get a refresh, I apologize for this basic question, but just, Phil, if you could help us -- remind us about the differences just in the devices, DrugSorb-ATR versus CytoSorbents. The reason I'm asking the question is just the study -- I think CytoSorb absorption during emergency cardiac operations in patients with a high risk of bleeding, I believe that CytoSorb is U.S. -- sorry, EU approval or CE Mark approval for the indication to remove antithrombotic cardiothoracic surgery. And just with that data that's out there and trying to kind of use that as a signal for the prospects of success for STAR-T. Just want to be reminded of the differences of those 2 devices.

恭喜您完成 STAR-T 的註冊。凱西，恭喜你退休。我希望能重溫一下，我對這個基本問題表示歉意，但菲爾，如果你能幫助我們，請提醒我們設備方面的差異，DrugSorb-ATR 與 CytoSorbents。我問這個問題的原因只是研究 - 我認為 CytoSorb 在出血風險高的患者的緊急心臟手術期間吸收，我相信 CytoSorb 是美國的 - 抱歉，歐盟批准或 CE 標誌批准該適應症解除心胸抗血栓手術。就利用現有的數據，並嘗試將其用作 STAR-T 成功前景的信號。只是想提醒一下這兩種設備的差異。

Yes. Thanks very much, Josh. So the DrugSorb uses an equivalent polymer technology to CytoSorb. But DrugSorb-ATR is more of a drug removal system with blood lines and other things that allow us to connect to the heart-lung machine. So from a technical perspective, what CytoSorb can do, DrugSorb can do. So if that is helpful.

是的。非常感謝，喬許。因此 DrugSorb 使用與 CytoSorb 等效的聚合物技術。但 DrugSorb-ATR 更像是一個藥物清除系統，具有血液線路和其他東西，使我們能夠連接到心肺機。所以從技術角度來說，CytoSorb能做到的，DrugSorb也能做到。如果這有幫助的話。

Absolutely. And just thinking about the interim analysis and getting through the -- any changes in the study protocol, I mean like that clear positive signal on the safety side. But is there any, I guess, clinical signals you would put forward either from real-world experience with CytoSorb as indication in Europe or clinical data, including that study that I just referenced in terms on the efficacy side for STAR-T that this signals that investors should be really considering as they're trying to analyze the potential success of the STAR-T study?

絕對地。只要考慮中期分析並完成研究方案中的任何變化，我的意思是像安全方面的明確積極信號一樣。但我想，您是否會從歐洲使用 CytoSorb 作為適應症的實際經驗或臨床數據中提出任何臨床信號，包括我剛剛在 STAR-T 功效方面引用的那項研究，表明這表明了這一點投資者在嘗試分析STAR-T 研究的潛在成功時應該真正考慮這一點嗎？

I can turn that over to Makis. Makis, would you like to handle that? And I can add color.

我可以把它交給馬基斯。馬基斯，你願意處理嗎？我可以添加顏色。

Thanks, Phil, and thanks for the question. So the -- as Phil mentioned previously, we have announced in our last earnings call that we're going forgo the interim analysis based on the speed of enrollment. So the fact that we completed the study so soon would not have allowed significant amount of time -- sufficient amount of time for the interim analysis to be performed.

謝謝菲爾，也謝謝你的提問。因此，正如菲爾之前提到的，我們在上次財報電話會議中宣布，我們將放棄基於註冊速度的中期分析。因此，我們這麼快完成研究的事實並沒有留出足夠的時間來進行中期分析。

However, by foregoing that, we did not have, not us nor the DSMB, any further insight into the efficacy side. And therefore, now the data remain fully blinded as they're being entered by the sites. They will undergo the process of being validated and cleaned, leading to database lock, as you heard earlier.

然而，如上所述，我們（無論是我們還是 DSMB）都沒有對功效方面有任何進一步的了解。因此，現在網站輸入的資料仍然是完全不知情的。正如您之前所聽到的，它們將經歷驗證和清理的過程，從而導致資料庫鎖定。

And obviously, after that, we will pursue the final analysis and the top line results of the study.

顯然，在那之後，我們將追求研究的最終分析和主要結果。

So until then, that -- we only have the DSMB review on the safety information of the trial, which we already reviewed today. We had 2 of those reviews that were both unremarkable without any findings and without any recommendations for changes in the trial. So that's a long way to tell you that as of now, the data remain blinded, but we do have the positive feedback for the safety of the study.

所以在那之前，我們只有 DSMB 對試驗的安全資訊進行審查，我們今天已經審查了這些資訊。我們有 2 篇評論，既沒有任何發現，也沒有任何改變試驗的建議，都平淡無奇。所以，要告訴你的是，到目前為止，數據仍然是盲目的，但我們確實得到了關於研究安全性的正面回饋。

Sorry, I'm just classifying the safety reviews as interim analysis. And then maybe lastly, just thinking about -- I may be getting a little bit ahead of myself, but think about the plans for STAR-T and potentially kicking that study off for Xarelto and Eliquis removal. I mean, will the catalyst be or, I guess, if you think about the decision tree, we need to see success in STAR-T to -- and prior to thinking about or initiating the STAR-T trial?

抱歉，我只是將安全審查歸類為中期分析。也許最後，只是想一想——我可能有點超前了，但想想 STAR-T 的計劃，並可能啟動針對 Xarelto 和 Eliquis 去除的研究。我的意思是，催化劑會是，或者，我猜，如果你考慮決策樹，我們需要看到 STAR-T 的成功，然後才能考慮或啟動 STAR-T 試驗？

Okay. So let me try to respond to that one as well. So the STAR-T trial, you start getting an addressable population that's even larger than the Ticagrelor population. And we've seen that not just on our literature review of the numbers that are out there but primarily from the direct feedback from the site. So we believe that the opportunity for these 2 blockbusters, Xarelto and Eliquis, is even greater than for Brilinta. So in that regard, it's definitely an opportunity worth pursuing.

好的。因此，讓我也嘗試對此做出回應。因此，在 STAR-T 試驗中，您開始獲得比替格瑞洛人群還要多的可尋址人群。我們不僅在對現有數字的文獻綜述中看到了這一點，而且主要從網站的直接回饋中看到了這一點。因此，我們認為 Xarelto 和 Eliquis 這兩款重磅藥物的機會甚至比 Brilinta 還要大。因此，從這方面來說，這絕對是一個值得追求的機會。

Now in relation to STAR-D, we are now in a very good position that we have the full apparatus to execute and study in place. From our clinical team -- our internal clinical team, all our vendors and our partners that we're working to execute the study, most importantly, the site network from STAR-T, these are highly performing sites. They did excellent STAR-T. So we believe that STAR-D, once we resumed, will actually be efficiently executed and be able to enroll fast.

現在就 STAR-D 而言，我們處於非常有利的位置，我們擁有完整的設備來執行和研究。來自我們的臨床團隊——我們的內部臨床團隊、我們正在努力執行這項研究的所有供應商和合作夥伴，最重要的是 STAR-T 的站點網絡，這些都是高效能站點。他們的 STAR-T 表現非常出色。因此，我們相信 STAR-D 一旦恢復，實際上將有效執行並能夠快速註冊。

The results of STAR-T will be very helpful, of course, especially relating to the safety of the device since the application is very similar. As you know, the STAR-D trial is targeting the same use of the device, intraoperatively for patients undergoing cardiac surgery. So there's a lot of similarities between the 2 trials that we discussed previously, but more importantly now, we have the playbook, the right partners and the right sites to execute briskly the STAR-D trial.

當然，STAR-T 的結果將非常有幫助，特別是與設備的安全相關，因為應用非常相似。如您所知，STAR-D 試驗的目標是在接受心臟手術的患者術中使用該設備。因此，我們之前討論的兩項試驗之間有很多相似之處，但更重要的是，現在我們有了劇本、合適的合作夥伴和合適的地點來快速執行 STAR-D 試驗。

And our next question will come from an Si of B. Riley.

我們的下一個問題將來自 B. Riley 的 Si。

Maybe I can start with a high-level question first, and then I have a follow-up. So first, during your market research, Phil, can you remind us the trend of using antidote for Anticoagulants, such as AndexXa, Praxbind in the U.S. and EU?

也許我可以先從一個高階問題開始，然後再提出後續問題。 Phil，首先，在您的市場調查過程中，您能否提醒我們使用抗凝血劑解毒劑的趨勢，例如美國和歐盟的 AndexXa、Praxbind？

Sure. And actually, Makis, this is an ideal question for you.

當然。事實上，馬基斯，這對你來說是一個理想的問題。

Sure. Thank you for the question. So the use of these reversal agents that are approved in the marketplace now, specifically Andexanet that is indicated for the reversal of the drugs we referenced before, the direct oral anticoagulant like Xarelto and Eliquis, is approved in the presence of severe life-threatening bleeding. So those drugs are used where somebody has suffered in life-threatening bleed. The usual measures are not successful in stopping the bleeding, and then they applied.

當然。感謝你的提問。因此，現在市場上批准使用這些逆轉劑，特別是 Andexanet，它適用於逆轉我們之前提到的藥物，即 Xarelto 和 Eliquis 等直接口服抗凝血劑，在存在嚴重危及生命的出血的情況下被批准。因此，這些藥物是在有人遭受危及生命的出血的情況下使用的。常規措施未能成功止血，遂施行。

The population that we are addressing is actually much larger populations. These are patients at risk for bleeding. So if you can imagine, these are patients who are coming in with a heart attack, they have their cardio angiogram, they see that they need surgery, but because they receive these drugs are sitting -- waiting for the drug to wash out at risk for having a second heart attack, for example, but they're not bleeding.

我們所面對的人口其實是更多的人口。這些是有出血風險的患者。所以，如果你能想像，這些病人是心臟病發作的，他們做了心臟血管造影，他們發現自己需要手術，但因為他們接受了這些藥物，所以他們坐著等待藥物被沖走，面臨風險例如，第二次心臟病發作，但他們沒有流血。

So in that population, it's -- as of now, there are no available solutions to help them have a timely operation -- a safe and timely operation. So these patients now are waiting in the hospitals for a long time. The drugs that we're referencing would only be indicated if they were bleeding.

因此，對於這些人群來說，到目前為止，還沒有可用的解決方案來幫助他們及時進行手術，這是一種安全、及時的手術。所以這些病人現在都在醫院等待很久。我們所引用的藥物只有在出血時才適用。

In addition, some case reports with these drugs were used in the setting of patients heading into surgery, especially relating to Xarelto and Eliquis, the reversal agent, Andexanet, can interfere with the necessary anticoagulation that are required when people are put on a heart-lung machine. So it poses also a complicating factor that may put the operation at risk, and therefore, are not widely used in this setting, and they're certainly not approved for that application.

此外，使用這些藥物的一些病例報告是在即將進行手術的患者中使用的，特別是與 Xarelto 和 Eliquis 相關的病例報告，逆轉劑 Andexanet 可能會幹擾人們接受心臟手術時所需的必要抗凝血作用。肺機。因此，它也帶來了一個複雜的因素，可能會使操作面臨風險，因此，在這種情況下沒有廣泛使用，而且它們肯定不會被批准用於該應用。

The reversal agent for the bigger trend, which has a very, very small piece of the pie of the market share for these Anticoagulants, does carry an indication that can be used because it has been studied also in people heading to cardiac surgery. Having said that, there are so few patients on this drug. Again, at least in our sites, we have not experienced any of the clinical teams using these drugs in the setting. They're all opting to just wait and let the drugs wash out, which is exactly unmet need that we believe can target by allowing the surgery to proceed while at the same time removing the offending agent and reducing the bleeding risk.

這種大趨勢的逆轉劑在這些抗凝血劑的市場份額中所佔的份額非常非常小，但它確實具有可以使用的適應症，因為它也已在接受心臟手術的患者中進行了研究。話雖如此，服用這種藥物的患者卻很少。同樣，至少在我們的網站上，我們還沒有經歷過任何臨床團隊在該環境中使用這些藥物。他們都選擇等待，讓藥物消失，這正是未滿足的需求，我們相信可以透過允許手術進行，同時去除有害物質並降低出血風險來實現這一目標。

Yes. Got it. As a follow-up here I have is -- I'm curious about the U.S. market when you have a third party or have third-party distributor. Can you clarify how you split the responsibility? Will you take on the responsibility of marketing and education, and then they do the face-to-face interaction with surgeon?

是的。知道了。我的後續行動是－當你有第三方或第三方經銷商時，我對美國市場感到好奇。你能澄清一下你是如何劃分責任的嗎？你會承擔行銷和教育的責任，然後他們與外科醫生進行面對面的互動嗎？

Vince, do you want to take that?

文斯，你想接受這個嗎？

Sure, Phil. I'll take that. Thanks. In the U.S., we plan to use a blended approach of direct sales and distributors. We have some strong distributors that we developed in -- during the COVID period, when we were selling CytoSorbents or CytoSorbents under EUA. And we will use those distributors in those select regions since they have very, very close relationships with the cardiac surgeons. And so the rest of the U.S., we intend to focus on direct sales, specifically with probably a sales force of about 19 people.

當然，菲爾。我會接受的。謝謝。在美國，我們計劃採用直銷和分銷商的混合方式。我們在新冠疫情期間開發了一些強大的經銷商，當時我們根據 EUA 銷售 CytoSorbents 或 CytoSorbents。我們將在這些選定的地區使用這些經銷商，因為他們與心臟外科醫生有著非常非常密切的關係。因此，在美國其他地區，我們打算專注於直銷，特別是擁有約 19 人的銷售團隊。

And our next question will come from Christopher Campbell of JEF.

我們的下一個問題將來自 JEF 的 Christopher Campbell。

This is Chris on for Mike. I was wondering if you could elaborate a little more on the trends you're seeing in the core German market and how that's trended so far through the third quarter.

這是克里斯替麥克發言。我想知道您是否可以詳細說明您在德國核心市場看到的趨勢以及第三季迄今為止的趨勢。

Yes, we -- thanks very much, Chris. We -- Christian, would you like to comment on that? There's only so much we can say about third quarter results so far. But Christian, feel free to try.

是的，我們——非常感謝，克里斯。我們——克里斯蒂安，你想對此發表評論嗎？到目前為止，我們對第三季業績只能說這麼多。但是克里斯蒂安，請隨意嘗試。

Yes. Thank you, and thank you for the question. So as Chris said, we cannot obviously comment on the third quarter. But as you have seen already in the first and second quarter, there's a significant improvement compared to last year. This is mainly because we have much better access to the hospital, but also we'll be, I think, carried in the next half year by a number of publications we have received over the first half.

是的。謝謝你，也謝謝你的提問。正如克里斯所說，我們顯然無法對第三季發表評論。但正如您在第一季和第二季已經看到的那樣，與去年相比有了顯著的改善。這主要是因為我們可以更好地進入醫院，而且我認為，我們將在下半年收到上半年收到的一些出版物。

So all this together has to balance. There's still critical or complicated situation in the hospitals. There are still ICU capacities blocked because there's not -- there's a shortage of staff, and there's still less cardiovascular interventions compared to before the pandemic.

因此，所有這些都必須平衡。醫院的情況仍然危急或複雜。重症監護病房的能力仍然受到阻礙，因為與大流行之前相比，工作人員短缺，心血管幹預措施仍然較少。

But the charts, which have been shown by Kathy, show that we are already much higher with the core business compared to the business before the pandemic but also considering the core business during the pandemic. I think It's a stable improvement. And yes, the second half, I think, show further stabilization.

但凱西展示的圖表顯示，與疫情大流行之前的業務相比，我們的核心業務已經高得多，並考慮到疫情期間的核心業務。我認為這是一個穩定的進步。是的，我認為下半年表現出進一步的穩定。

And our next question will come from Jim with Alliance Global Partners.

我們的下一個問題將由吉姆和全球聯盟合作夥伴提出。

This is Lora Real calling in for Jim Loy. So with enrollment now complete for the STAR-T trial and on top line data set to be announced by the end of the year, what type of data are you specifically anticipating in order to submit your regulatory submissions to both the FDA and Health Canada?

我是洛拉·雷爾 (Lora Real) 給吉姆·洛伊 (Jim Loy) 打電話。因此，隨著 STAR-T 試驗的註冊現已完成，並且頂級數據集將於今年年底公佈，您具體期望什麼類型的數據，以便向 FDA 和加拿大衛生部提交監管材料？

Thank you, Lora. Makis and Irina, would you like to take that?

謝謝你，洛拉。 Makis 和 Irina，你願意接受嗎？

Yes, I can take that. We consider that -- at this point, we don't know the results of a clinical study, STAR-T. But it is in the mid control study, and data is blinded until the final analysis would be completed. This data would be sufficient to support regulatory filing in United States and in Canada. This data also might be used in some other territories. But at this point, the United States and Canada would -- regulatory submissions would be relying consulate.

是的，我可以接受。我們認為，目前我們還不知道 STAR-T 臨床研究的結果。但這是中期對照研究，在最終分析完成之前數據是盲的。這些數據足以支持美國和加拿大的監管備案。該數據也可能在其他一些地區使用。但此時，美國和加拿大將依賴領事館提交監管申請。

And maybe, Makis, you can talk about the -- Makis, maybe you could talk about the primary endpoint and some of the secondary endpoints as well.

也許，Makis，你可以談談——Makis，也許你也可以談談主要終點和一些次要終點。

Sure. Thanks for the question. So I think like with any regulatory review, the agency will have to perform a benefit-risk analysis for this proposed new intervention. So the STAR-T is designed to provide all that information. So first of all, the safety, and we already talked about this on this call, we had some interim reviews and we'll have a final review as well. So safety will certainly be supported by the data for STAR-T for the necessary review by the agency.

當然。謝謝你的提問。因此，我認為與任何監管審查一樣，該機構必須對這項擬議的新幹預措施進行利益-風險分析。因此 STAR-T 旨在提供所有這些資訊。首先，安全性，我們已經在這次電話會議上討論過這一點，我們進行了一些中期審查，我們還將進行最終審查。因此，安全性肯定會得到 STAR-T 數據的支持，以便該機構進行必要的審查。

For efficacy, we are looking at 2 specific things in STAR-T. First of all, we want to establish the mechanism of action. So we're looking for the drug removal of the drug to actually be validated in [vivo] . We're going to be measuring the levels of the drug before surgery and after surgery. That's actually the key secondary endpoint of the trial to show that the drug is effectively removed from circulation compared to the control arm when the device is not used.

為了提高功效，我們正在研究 STAR-T 中的兩個具體內容。首先，我們要建立行動機制。因此，我們正在尋找能夠在 [vivo] 中實際驗證的藥物去除方法。我們將在手術前和手術後測量藥物的水平。這實際上是該試驗的關鍵次要終點，表明在不使用該裝置時，與控制臂相比，該藥物已有效地從循環中去除。

The second piece of the efficacy, which is actually the primary endpoint of the trial, is a composite endpoint looking at various events that cause bleeding -- perioperative bleeding. So we're measuring things like transfusions. We're measuring things like the amount of blood that comes out of the chest after the operation. And that will give us a picture of the overall bleeding rates between the intervention on the control arm.

功效的第二部分其實是試驗的主要終點，是一個綜合終點，著眼於導致出血的各種事件－圍手術期出血。所以我們正在測量諸如輸血之類的事情。我們正在測量手術後從胸部流出的血量等數據。這將使我們了解控制臂介入之間的整體出血率。

So I think the overall information from the STAR-T trial will be sufficient to -- for the agency to review to come up with the benefit-risk analysis necessary during this process.

因此，我認為 STAR-T 試驗的總體資訊足以讓該機構進行審查，以提出在此過程中必要的利益-風險分析。

Understood. And may you also go over the joint marketing agreement that you answered with Humedics and the LIMAX diagnostic tool? And then what might you expect in terms of increased customer awareness and use for both of the products involved?

明白了。您也可以回顧一下您與 Humedics 和 LIMAX 診斷工具簽訂的聯合行銷協議嗎？那麼，您對提高客戶對這兩種產品的認知度和使用率有何期望？

Yes. Why don't -- Chris, why don't you take that one?

是的。為什麼不——克里斯，你為什麼不拿那個？

Yes. Thank you, Phil. Yes, thank you for the question. As Phil had mentioned, Humedics has a really innovative, noninvasive liver function test. And basically, what it helps physicians do to assess how much liver function a patient may have. And they got to start with presurgical planning, but I think ideally, what we hope to do is to leverage the test, and as Phil had mentioned, use this as a diagnostic test to help stratify and identify the right patients who would ultimately be best suited for our treatment. So that's I would categorize that as maybe near a mid- to later objective of the partnership.

是的。謝謝你，菲爾。是的，謝謝你的提問。正如 Phil 所提到的，Humedics 擁有真正創新的、非侵入性的肝功能測試。基本上，它可以幫助醫生評估患者的肝功能程度。他們必須從術前計劃開始，但我認為理想情況下，我們希望做的是利用該測試，正如菲爾所提到的，將其用作診斷測試，以幫助分層和識別最終最好的合適患者適合我們的治療。因此，我將其歸類為可能接近合作夥伴關係的中後期目標。

But today, we're leveraging the commercial organizations to get in front of key customers for our product, customers like hepatologists, hepatic surgeons and others. And I think the real near-term benefit of this is that the partnership could be valuable because it will help introduce us to customers who may not yet be familiar with CytoSorb but could be good buyers of the product. So I think this is just another way for us to accelerate our commercial efforts in the field of liver therapy.

但今天，我們正在利用商業組織來吸引我們產品的關鍵客戶，例如肝病專家、肝外科醫生等客戶。我認為，這種合作關係的真正近期好處是，這種合作關係可能很有價值，因為它將有助於將我們介紹給可能還不熟悉 CytoSorb 但可能是該產品的良好買家的客戶。所以我認為這只是我們加速肝臟治療領域商業化努力的另一種方式。

And our next question will come from Sean Lee of H.C. Wainwright.

我們的下一個問題將來自 H.C. 的 Sean Lee。溫賴特。

My first one is on the U.S. market -- potential U.S. market for DrugSorb-ATR. So you mentioned a -- currently a $250 million opportunity. So I was wondering how many of these cardiac surgeries per year that are sort of using Ticagrelor -- in patients using Ticagrelor that you believe could be benefit from DrugSorb-ATR?

我的第一個目標是美國市場—DrugSorb-ATR 的潛在美國市場。所以你提到了一個目前價值 2.5 億美元的機會。所以我想知道每年有多少心臟手術使用了替格瑞洛——您認為使用替格瑞洛的患者可以從 DrugSorb-ATR 中受益？

Thanks, Sean. Makis, would you like to take that one?

謝謝，肖恩。馬基斯，你想買那個嗎？

Sure. So what Phil showed you today is that the acute coronary treatment syndrome patients, which is about 1 million or more admissions as such in the U.S. every year, require the use of Antiplatelet drugs. Aspirin is one, but they also require one of these P2Y12 inhibitors.

當然。那麼菲爾今天向大家展示的是，美國每年約有100萬或更多的急性冠狀動脈治療症候群患者需要使用抗血小板藥物。阿斯匹靈就是其中之一，但它們也需要其中一種 P2Y12 抑制劑。

The position of Ticagrelor within that marketplace is constantly improving based on the very good efficacy data, especially over Plavix. So the number of patients on Ticagrelor have been growing over the past few years, and we believe that trend will continue to go up with the generic availability of the drug and obviously, hopefully, potentially the availability of DrugSorb.

基於非常好的療效數據，替格瑞洛在該市場的地位不斷提高，尤其是相對於波立維。因此，在過去幾年中，服用替格瑞洛的患者數量一直在增長，我們相信，隨著該藥物的仿製藥上市，以及 DrugSorb 的上市，這一趨勢將繼續上升。

So from all those patients, about 100,000 of them out of this 1 million, about 10% when they present with ACS will require surgery. And that surgery takes place in the hospital. These are not patients that are stable enough to be sent home, to be allowed to stop the drug and then come back for surgery without risk of bleeding. They are staying in the hospital being monitored. And currently, these hospitals are waiting multiple days until they can be operated.

因此，在所有這些患者中，這 100 萬人中約有 10 萬人，即 10% 的 ACS 患者需要手術。手術是在醫院進行的。這些患者病情穩定，無法出院回家，也無法停藥然後回來接受手術，不會有出血的風險。他們正在醫院接受監測。目前，這些醫院正在等待多天才能投入營運。

The amount of patients from those 100,000 that are on Ticagrelor we estimate -- like I said before, we have estimated in the past that the market share for Ticagrelor is approximately half of that market and may potentially grow even more in the future. So that -- those are the assumptions behind the number that Phil has quoted previously about the total addressable market with this device.

我們估計這 10 萬名服用替格瑞洛的患者數量——就像我之前所說的，我們過去估計替格瑞洛的市場份額約為該市場的一半，並且未來可能會增長更多。因此，這些是菲爾之前引用的有關該設備總潛在市場的數字背後的假設。

So to summarize, about 10% of patients presenting with an acute coronary syndrome need to go to surgery. These patients are on P2Y12 inhibitors and aspirin, dual anti-platelet therapy. And the percentage of Ticagrelor patients within that population is high and will continue to grow, we believe, with the generic availability of the drug.

總而言之，大約 10% 的急性冠狀動脈綜合徵患者需要接受手術。這些患者正在接受 P2Y12 抑制劑和阿斯匹靈雙重抗血小板治療。我們相信，隨著該藥物的仿製藥上市，替格瑞洛患者在該族群中所佔的比例很高，並將繼續成長。

Great. My second question is on your commercial planning in the U.S. and Canada. So you mentioned that you expect to start building out a direct sales team starting next year. So I was wondering, would you be pursuing an entirely 2 deck sales or a hyper model, where you have some direct sales surgeries and some distributors? And in terms of personnel, what's the size of the sales team that you're looking at?

偉大的。我的第二個問題是關於你們在美國和加拿大的商業規劃。您提到您預計從明年開始建立直銷團隊。所以我想知道，您會追求完全 2 層銷售還是超級模式，其中您有一些直銷手術和一些分銷商？就人員而言，您正在尋找的銷售團隊的規模是多少？

Yes, Vince, would you like to cover that?

是的，文斯，你想報道一下嗎？

Sure. Thanks, Sean, for the question. So we do plan to do a hybrid model, Sean. We have some good distributors from the COVID EUA program that are -- actually are specialists in cardiopulmonary bypass equipment. And so we will combine that with a direct sales force of about 19 people.

當然。謝謝肖恩提出問題。所以我們確實計劃做一個混合模型，肖恩。我們有一些來自新冠 EUA 計劃的優秀經銷商，他們實際上是心肺旁路設備的專家。因此，我們將把它與大約 19 人的直銷隊伍結合起來。

I think with the distributors, they have the established relationships. And so we would obviously leverage their Rolodex to get into those accounts quickly to establish the use of DrugSorb-ATR. And then in the rest of country, we will go in with a direct sales force, and that will be roughly about 19 people. Does that answer your question?

我認為他們與經銷商有著既定的關係。因此，我們顯然會利用他們的 Rolodex 快速進入這些帳戶，以建立 DrugSorb-ATR 的使用。然後在該國其他地區，我們將派出一支直銷隊伍，大約有 19 人。這是否回答你的問題？

I think the other thing to note is that at the price points that we're talking about in the United States, we've talked about a number of about $5,000 per cartridge compared to $1,000 for CytoSorb in the European Union. Our product gross margins for DrugSorb-ATR are expected to be well above 90%. So with a highly profitable, high-margin disposable device such as DrugSorb-ATR, the payback on sales of that product is very quick.

我認為另一件值得注意的事情是，就我們在美國談論的價格而言，我們談論的價格約為每盒 5,000 美元，而歐盟的 CytoSorb 價格為 1,000 美元。我們的 DrugSorb-ATR 產品毛利率預計將遠高於 90%。因此，對於 DrugSorb-ATR 等高利潤、高利潤的一次性設備，該產品的銷售回報非常快。

And I think I was telling someone the other day that we have a lot of experience in terms of commercialization experience based upon our -- what we've been doing in Europe. We, again, have been in the market for now 11 years with CytoSorb and have a full-fledged, fully operational sales and marketing commercialization team that has a gamut of sales and marketing folks but also product support, clinical support, clinical and medical affairs and application specialists, customer service, et cetera, et cetera. We look to replicate that here in the United States and know how to do this cost effectively and so are looking forward to the opportunity to do that here in the U.S.

我想我前幾天告訴某人，我們在商業化方面擁有豐富的經驗，這些經驗是基於我們在歐洲所做的事情。我們再次與 CytoSorb 一起進入市場 11 年，並擁有一支成熟、全面運作的銷售和行銷商業化團隊，該團隊不僅有銷售和行銷人員，還包括產品支援、臨床支援、臨床和醫療事務以及應用專家、客戶服務等等。我們希望在美國複製這一點，並知道如何以成本有效的方式做到這一點，因此我們期待有機會在美國做到這一點。

(Operator Instructions) Our next question will come from Tom Kerr of Zacks SCR.

（操作員說明）我們的下一個問題將來自 Zacks SCR 的 Tom Kerr。

I think most of my questions have been asked. Just a couple of quick ones and some financial ones. You guys don't talk about those programs under development much anymore. Any comment on that? The HemoDefend and the contrast and that sort of stuff, are you still working on those efforts?

我想我的大部分問題都被問到了。只是一些快速的和一些財務的。你們不再談論那些正在開發的程式了。對此有何評論？ HemoDefend 和對比之類的東西，您還在努力嗎？

Absolutely. The HemoDefend-BGA program is the beneficiary of more than $15 million in government grant funding, particularly from the Department of Defense. It is a priority actually for our R&D program outside of the work that we're doing on CytoSorb and other key programs, and it is well funded.

絕對地。 HemoDefend-BGA 計劃受益於超過 1500 萬美元的政府撥款，特別是來自國防部的撥款。實際上，這是我們在 CytoSorb 和其他關鍵項目上所做的工作之外的研發項目的優先事項，而且資金充足。

And so if you're seeing a lot of the press releases we put out on these technologies, we have funding to really bring it to clinical studies and potentially even commercialization. So we are active on that. I think we're making some outstanding progress. We are looking to address multiple different markets, including military markets, including civilian transfusion markets as well as plasma processing markets with our technology because we believe that universal plasma has a place in each of those verticals.

因此，如果您看到我們發布的有關這些技術的大量新聞稿，我們有資金真正將其引入臨床研究，甚至可能商業化。所以我們對此很積極。我認為我們正在取得一些顯著的進展。我們希望利用我們的技術來滿足多個不同的市場，包括軍事市場、民用輸血市場以及血漿處理市場，因為我們相信通用血漿在每個垂直領域都佔有一席之地。

We really look forward to the day when a bag of freeze-dried universal plasma is on every -- or multiple bags of freeze-dried plasma is in every ambulance, for example, in the world given that plasma is a life-saving product with lots of beneficial components in it, such as coagulation factors and other things that are very useful for trauma patients and are much better at resuscitating patients than what they're using today, which is simple saline. And so you can imagine how large this opportunity could be worldwide. And it's one of the reasons why we're very excited about that program. We don't talk about it much, but be very clear that we are making some nice progress.

我們真的很期待有一天，世界上每輛救護車上都會配備一袋凍乾通用血漿，或者每輛救護車上都會配備多袋凍乾血漿，因為血漿是一種拯救生命的產品，其中含有許多有益成分，例如凝血因子和其他對創傷患者非常有用的物質，並且比他們今天使用的簡單鹽水更能幫助患者復甦。所以你可以想像這個機會在全球範圍內有多大。這也是我們對該計劃感到非常興奮的原因之一。我們對此談得不多，但很清楚我們正在取得一些不錯的進展。

Okay. Great. A couple of quick financial questions, though. The burn rate expected to remain around $4.5 million. As you guys stated in the press release, you're funded through 2023, but you have substantial more liquidity than that. Just trying to get that data and figure that out.

好的。偉大的。不過，有幾個簡單的財務問題。燒錢率預計將維持在 450 萬美元左右。正如你們在新聞稿中所說，你們的資金到 2023 年為止，但你們的流動性遠不止於此。只是想獲取這些數據並找出答案。

Kathy, did you want to address that?

凱西，你想解決這個問題嗎？

Yes, I'll take that. Thanks, Phil, and thank you for the question. So our cash burn moving forward is estimated to be around $4 million a quarter. That's just what we're expecting as we move into 20 -- out of 2023 and into 2024.

是的，我會接受的。謝謝菲爾，也謝謝你提出的問題。因此，我們預計每季的現金消耗約為 400 萬美元。這正是我們進入 20 年後（從 2023 年到 2024 年）的預期。

Of course, beginning with -- when we begin to have sales in the U.S. of DrugSorb-ATR, Phil already mentioned that it's a very quick payback. And it is -- and we're targeting average selling prices of around $5,000 versus the $1,000 that we sell CytoSorb for currently. So what are now up to 80% gross margins will be very high 90% gross margins on those products. So they'll be very profitable. We do have an ATM in place. We do have the ability to borrow additional debt if need be to extend the cash runway.

當然，當我們開始在美國銷售 DrugSorb-ATR 時，Phil 已經提到這是一個非常快速的回報。確實如此，我們的目標平均售價約為 5,000 美元，而目前 CytoSorb 的售價為 1,000 美元。因此，這些產品現在的毛利率高達 80%，屆時毛利率將達到 90%。所以他們會非常有利可圖。我們確實有一台自動櫃員機。如果需要延長現金跑道，我們確實有能力借入額外的債務。

Okay. I think I understand, but it seems like with that amount of liquidity and a $4 million burn rate, you'd be funded beyond 2023 instead of through 2023. But maybe I'm reading into that too much.

好的。我想我理解，但似乎有了這麼多的流動性和 400 萬美元的燒錢率，你將在 2023 年之後而不是 2023 年之前獲得資助。但也許我對此理解太多了。

No, you're reading it right. It will be beyond 2023.

不，你沒看錯。它將超過2023年。

Well, if there are no -- okay, operator, sorry?

好吧，如果沒有——好的，接線員，抱歉？

I'm sorry, there are no further questions. I'd like to turn the call back to you, Phil, for closing remarks.

抱歉，沒有其他問題了。菲爾，我想把電話轉回給你，請你作結束語。

Thank you, Tanya. Well, thank you, everyone, for joining the call today, and a special thanks for the analysts who asked some excellent questions. If you do have any other questions, please feel free to reach out to Kathy Bloch this week at kbloch@cytosorbents.com or me at pchan@cytosorbents.com, and we'll reply to your questions where possible. We look forward to our next quarterly call. Thank you, everyone, very much. Have a great evening.

謝謝你，塔妮亞。好的，謝謝大家參加今天的電話會議，特別感謝分析師提出了一些精彩的問題。如果您確實有任何其他問題，請隨時透過本週 kbloch@cytosorbents.com 聯繫 Kathy Bloch，或透過 pchan@cytosorbents.com 聯繫我，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。祝您有個美好的夜晚。

Thank you. That concludes our conference for today. I'd like to thank everyone for their participation.

謝謝。我們今天的會議到此結束。我要感謝大家的參與。