Cytosorbents Corp (CTSO) 2024 Q2 法說會逐字稿

Ladies and gentlemen, good afternoon, and welcome to the CytoSorbents Second-Quarter 2024 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the company's request.

女士們、先生們，下午好，歡迎參加 CytoSorbents 2024 年第二季財務與營運業績電話會議。此時，所有參與者都處於只聽模式。在正式發言之後，我們將開始電話詢問您的問題。請注意，我們將根據公司的要求對通話進行錄音。

At this time, I'd like to turn the call over to our moderator, Eric Ribner. Please go ahead, Mr. Ribner.

現在，我想將電話轉給我們的主持人 Eric Ribner。請繼續，里布納先生。

Thank you, and good afternoon. Welcome to CytoSorbents second quarter 2024 financial and operating results conference call. Joining me today from the company are Dr. Phil Chan, Chief Executive Officer; Vincent Capponi, President and Chief Operating Officer; Kathleen Bloch, 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; and Christopher Cramer, Senior Vice President of Business Development.

謝謝你，下午好。歡迎參加 CytoSorbents 2024 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 Phil Chan 博士；文森‧卡波尼 (Vincent Capponi)，總裁兼營運長；凱瑟琳‧布洛赫，財務長； Efthymios Deliargyris 博士，首席醫療官； Christian Steiner 博士，CytoSorbents Europe 銷售與行銷執行副總裁兼董事總經理；克里斯多福‧克萊默 (Christopher Cramer)，業務開發資深副總裁。

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 the 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，管理層準備好的言論可能包含前瞻性陳述，這些陳述存在風險和不確定性。管理層可能會針對您今天的問題做出更多前瞻性陳述。因此，該公司要求 1995 年《私人證券訴訟改革法案》中包含的前瞻性聲明受到安全港的保護。

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 13, 2024, 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。管理層對公司未來業績的任何預測均包括截至 2024 年 8 月 13 日的當前預測，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 the first quarter of 2024 by Dr. Chan, Ms. Bloch. Mr. Capponi and Dr. Deliargyris. Following the 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 2024 年第一季的營運和財務亮點。卡波尼先生和德利亞吉里斯博士。演示結束後，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. Phillip Chan.

現在我很高興將電話轉給 Phillip Chan 博士。

Well, thank you very much, Eric, and good afternoon, everyone to the Q2 2024 earnings call. First I'd like to go over our operating highlights for the quarter. First, more than 0.25 million CytoSorb devices have been cumulatively delivered to date, helping us save many lives around the world. Second, in the second quarter, total revenue increased 5% to $9.9 million while product sales increased by 10% to $8.8 million and gross product margins were solid at 75%.

非常感謝您，Eric，大家下午好，參加 2024 年第二季財報電話會議。首先，我想回顧一下我們本季的營運亮點。首先，迄今為止已累計交付超過 25 萬台 CytoSorb 設備，幫助我們拯救了世界各地的許多生命。其次，第二季總營收成長 5%，達到 990 萬美元，產品銷售額成長 10%，達到 880 萬美元，毛利率穩定在 75%。

Importantly, our second quarter operating loss decreased 48% to $3.4 million from $6.6 million a year ago. Following our $10.3 million equity raise in December 2023, we secured an additional $20 million credit facility with Avenue Capital Group, strengthening our balance sheet.

重要的是，我們第二季的營業虧損從去年同期的 660 萬美元下降到 340 萬美元，下降了 48%。繼 2023 年 12 月籌集 1,030 萬美元股權後，我們從 Avenue Capital Group 獲得了額外 2,000 萬美元的信貸額度，從而加強了我們的資產負債表。

And following the quarter, we completed additional cutbacks expected to save an additional annualized $5 million in expenses going forward. Over the past five months, we have decreased our workforce by 17%. Finally, our cash balance at the end of the second quarter was $14.9 million, including $8.5 million in unrestricted cash and $6.5 million in restricted cash.

在本季之後，我們完成了額外的削減，預計未來將額外節省 500 萬美元的年化費用。過去 5 個月，我們的員工人數減少了 17%。最後，第二季末我們的現金餘額為 1,490 萬美元，其中包括 850 萬美元的非限制性現金和 650 萬美元的限制性現金。

Today, we are pleased to announce the start of our new Chief Financial Officer, Peter J. Mariani, starting tomorrow. And unfortunately, the retirement of our existing CFO, Kathy Bloch, as of the end of business today. You'll hear more from both people at the end of this meeting.

今天，我們很高興地宣布新任財務長 Peter J. Mariani 將於明天上任。不幸的是，我們現有的財務長凱西·布洛赫 (Kathy Bloch) 從今天營業結束時退休。在本次會議結束時，您會聽到更多關於雙方的資訊。

We're also on track to set marketing applications in parallel for the investigational DrugSorb-ATR system to the FDA as a De Novo application and Health Canada in this third quarter of this year. You'll hear more about that from both Efthymios Deliargyris as well as Vince Capponi.

我們也計劃在今年第三季向 FDA 和加拿大衛生部同時提交研究性 DrugSorb-ATR 系統的行銷申請，作為 De Novo 申請。您將從 Efthymios Deliargyris 和 Vince Capponi 那裡聽到更多相關資訊。

In addition, we completed our MDSAP audit, which is a key requisite to Canadian commercialization. Data from our STAR registry was presented at the EuroPCR 2024 Conference and was selected as a top five finalist in the best scientific abstract competition. And importantly, we launched a new redesigned modern consolidated corporate and product website.

此外，我們也完成了 MDSAP 審核，這是加拿大商業化的關鍵前提。我們的 STAR 註冊數據已在 EuroPCR 2024 會議上展示，並被選為最佳科學摘要競賽的前五名決賽入圍者。重要的是，我們推出了一個新的、重新設計的現代綜合企業和產品網站。

Lastly, we also launched our CytoSorb, our PuriFi -- MDR certified PuriFi hemoperfusion pump, placing in fact, all 30 pumps from our original order with our OEM and are expecting delivery on the next order from our OEM very shortly. Importantly that the pump itself has received extremely well good reviews from users citing it as very easy to use and easy to set up and easy to implement our therapies.

最後，我們還推出了CytoSorb，我們的PuriFi——經MDR 認證的PuriFi 血液灌流泵，事實上，我們將原始訂單中的所有30 個泵都交給了我們的OEM，預計我們的OEM 的下一個訂單很快就會交付。重要的是，該泵本身受到了用戶的高度評價，認為它非常易於使用、易於設置且易於實施我們的治療。

With that, let me turn it over to Kathy Bloch, our current Chief Financial Officer, Kathy?

那麼，讓我把它交給我們現任財務長凱西·布洛赫（Kathy Bloch），凱西？

Thank you, Phil, and hello to everyone on the call. Today, I will discuss our second quarter 2024 financial results, including revenues and gross margins. And additionally, I will provide an update on our working capital and cash runway. CytoSorb product revenue was approximately $8.8 million in the second quarter of 2024 compared to $8.1 million in the second quarter of 2023, an increase of approximately $800,000 or 10%.

謝謝你，菲爾，並向通話中的每個人問好。今天，我將討論我們 2024 年第二季的財務業績，包括收入和毛利率。此外，我將提供有關我們的營運資金和現金跑道的最新資訊。2024 年第二季 CytoSorb 產品營收約 880 萬美元，而 2023 年第二季為 810 萬美元，成長約 80 萬美元或 10%。

Second quarter 2024 grant revenue was approximately $1.1 million compared to approximately $1.3 million in 2023, and this decrease was due to the conclusion of several brands during 2023. Total second quarter 2024 revenue, which includes both product sales and grant revenue, was approximately $9.9 million as compared to $9.4 million in 2023. And product gross margins on devices and device accessories with 75% in the second quarter of 2024 compared to product gross margins of 74% in 2023.

2024 年第二季的贈款收入約為 110 萬美元，而 2023 年約為 130 萬美元，這一下降是由於多個品牌在 2023 年期間結束。2024 年第二季的總收入（包括產品銷售和補助收入）約為 990 萬美元，而 2023 年為 940 萬美元。2024 年第二季設備與設備配件的產品毛利率為 75%，而 2023 年的產品毛利率為 74%。

Next slide, please. For the first half of 2024, CytoSorb product revenue was approximately $17.8 million compared to approximately $16 million for the first half of 2023, which is an increase of approximately $1.8 million or 12%.

請下一張投影片。2024年上半年，CytoSorb產品收入約1,780萬美元，而2023年上半年約1,600萬美元，增加了約180萬美元或12%。

First half 2024 grant revenue was $1.8 million as compared to $2.9 million, again, due to the conclusion of several grants in 2023. And product gross margins on devices and accessories were 74% in the first half of 2024 compared to 71% in the first half of 2023 as we continue to realize more operating efficiencies at our new manufacturing plant in Princeton, New Jersey.

由於 2023 年完成了多項贈款，2024 年上半年贈款收入為 180 萬美元，而這一數字為 290 萬美元。隨著我們繼續提高新澤西州普林斯頓新製造工廠的營運效率，2024 年上半年設備和配件的產品毛利率為 74%，而 2023 年上半年為 71%。

Next slide, please. The blue bars on this chart represent our annual product sales for the trailing 12-month period ending June 30 for each year 2018 to 2024. We know that for the years 2020, 2021 and 2022, sales were very favorably impacted because CytoSorb is used to treat COVID-19 patients. And of course, this usage ceased following the containment of the pandemic in the years ending June 30, 2023, and 2024.

請下一張投影片。此圖表上的藍色長條代表 2018 年至 2024 年截至 6 月 30 日的過去 12 個月期間的年度產品銷售額。我們知道，由於 CytoSorb 用於治療 COVID-19 患者，2020 年、2021 年和 2022 年的銷售額受到了非常有利的影響。當然，在截至 2023 年 6 月 30 日和 2024 年的幾年中，這種用法在疫情得到遏制後停止了。

If we take a look at the orange trend arrow, which tracks along core non-COVID-19 revenue. What we see is that the post-COVID-19 12-month periods ended June 30, 2023, and 2024, continue to show positive growth in our core non-COVID-19 product sales.

如果我們看一下橙色趨勢箭頭，它會追蹤核心非 COVID-19 收入。我們看到，截至 2023 年 6 月 30 日和 2024 年 6 月 30 日的 COVID-19 後 12 個月期間，我們的核心非 COVID-19 產品銷售持續呈現正成長。

Our year-over-year trailing 12-month sales for the period ending June 30, 2024, increased by 9.5% compared to the trailing 12-month sales for the period ended June 30, 2023. Additionally, excluding the impact of the COVID-19 sales in 2020, 2021 and 2022, our overall CAGR for the six years ended June 30, 2024, is a respectable 11.2%.

與截至 2023 年 6 月 30 日的過去 12 個月銷售額相比，我們截至 2024 年 6 月 30 日的過去 12 個月銷售額同比增長了 9.5%。此外，排除 2020 年、2021 年和 2022 年 COVID-19 銷售的影響，我們截至 2024 年 6 月 30 日的六年的總體複合年增長率為 11.2%。

I also want to point out for a moment that the green line, which tracks our year-over-year gross margin, indicates a decline in 2022, while we transitioned manufacturing operations to our new facility. Our second quarter 2024 gross margins continue to show improvement at 75%, and these margins are approaching the levels that we had prior to our move to the new facility. With greater volumes, we expect to show further improvements in product gross margins as we continue to realize additional manufacturing efficiencies.

我還想指出，追蹤我們同比毛利率的綠線表明 2022 年毛利率會下降，同時我們將製造業務轉移到新工廠。我們的 2024 年第二季毛利率持續改善，達到 75%，這些利潤率正在接近我們搬到新工廠之前的水平。隨著產量的增加，隨著我們繼續提高製造效率，我們預計產品毛利率將進一步提高。

Next slide, please. As of June 30, 2024, we have $14.9 million in cash, which includes $6.5 million of restricted cash and $8.5 million in unrestricted cash. We believe that unrestricted cash on hand is sufficient to fund the company's operations through the second quarter of 2025. We have been successful in our efforts to strengthen our balance sheet and reduce operating expenses.

請下一張投影片。截至 2024 年 6 月 30 日，我們擁有 1,490 萬美元現金，其中包括 650 萬美元限制性現金和 850 萬美元非限制性現金。我們認為，手頭上不受限制的現金足以為公司到 2025 年第二季的營運提供資金。我們在加強資產負債表和減少營運費用方面取得了成功。

On our last call, we indicated that the company was actively pursuing alternative sources of capital. And in June 2024, we entered into a loan and security agreement with the Avenue Group of Funds to provide a total of $20 million in debt financing. $10 million was immediately available under the facility and $5 million, which is included in our restricted cash, is subject to release by March 31, 2025, provided that the FDA has accepted the company's application for review with respect to DrugSorb-ATR and that the company has received a minimum of $3 million in net proceeds from the sale of its equity securities after the closing date.

在上次電話會議中，我們表示該公司正在積極尋求其他資本來源。2024 年 6 月，我們與 Avenue Group of Funds 簽訂了貸款和擔保協議，提供總額為 2,000 萬美元的債務融資。該設施下立即提供 1000 萬美元，500 萬美元（包含在我們的限制性現金中）將於 2025 年 3 月 31 日之前發放，前提是 FDA 已接受該公司有關 DrugSorb-ATR 的審查申請，並且公司在交割日後透過出售其股本證券獲得了至少300 萬美元的淨收益。

The restricted cash will be released on a dollar-for-dollar basis for equity raised between $3 million and $5 million. And then there's another tranche of $5 million, which may be dispersed at the company's request between July 1, 2025, and December 31, 2025, provided that the company received FDA marketing approval of its DrugSorb-ATR application. Conservation of cash remains a top corporate priority. We have reduced our head count, adjusted our spending and taking other measures to reduce our quarterly cash burn in 2024.

所籌集的股本金額在 300 萬至 500 萬美元之間，受限現金將以美元兌美元釋放。然後還有另一筆500 萬美元，如果該公司獲得FDA 對其DrugSorb-ATR 申請的營銷批准，則可以根據該公司的要求在2025 年7 月1 日至2025 年12 月31 日之間進行分配。節約現金仍是企業的首要任務。我們已經減少了員工人數、調整了支出並採取了其他措施，以減少 2024 年的季度現金消耗。

Cost cuts taken previously have reduced our loss from operations from $6.6 million in the second quarter of 2023 to $3.4 million in the second quarter of 2024, a 48% decrease. In July of 2024, we enacted another round of cost cuts, which are designed to reduce the company's annual cash burn by an additional $5 million. And that will conclude my remarks for today.

先前採取的成本削減措施使我們的營運損失從 2023 年第二季的 660 萬美元減少到 2024 年第二季的 340 萬美元，減少了 48%。2024 年 7 月，我們實施了另一輪成本削減，旨在將公司每年的現金消耗額外減少 500 萬美元。我今天的發言就到此結束。

And at this time, I'm delighted to turn the call over to our President and Chief Operating Officer, Vince Capponi. Go ahead, Vince.

此時，我很高興將電話轉給我們的總裁兼營運長文斯卡波尼 (Vince Capponi)。繼續吧，文斯。

Thank you, Kathy. So for the -- I'd like to cover the clinical --

謝謝你，凱西。所以對於－我想介紹一下臨床--

Yes. I think Efthymios is on the call. Efthymios, would you like to take the first part of this?

是的。我認為 Efthymios 正在通話中。Efthymios，您想聽第一部分嗎？

Sure. Thanks, Bill. Thanks, Vince. As you heard -- and welcome to everybody on our call this afternoon. As you heard from Phil previously, the regulatory submissions for our investigational DrugSorb-ATR system is a top priority for the company. And we are happy to report that we're on track according to previously stated time lines.

當然。謝謝，比爾。謝謝，文斯。正如您所聽到的，歡迎今天下午參加我們電話會議的所有人。正如您之前從 Phil 那裡聽到的，我們的研究性 DrugSorb-ATR 系統的監管提交是該公司的首要任務。我們很高興地報告，我們正在按照之前規定的時間表步入正軌。

The STAR-T clinical data were presented earlier this year, the top line results and the filing data analysis has been completed. And in fact, the clinical study report that contains all this information is in the final stages of development and publishing.

STAR-T 臨床數據已於今年稍早公佈，頂線結果和備案數據分析已經完成。事實上，包含所有這些資訊的臨床研究報告正處於開發和發布的最後階段。

This will represent the main source for the probable benefit to risk allowances that will be at the crux of our De Novo submission to the FDA. We also intend to include in the submission supportive supplementary data with the real-world evidence of ticagrelor removal during CABG that was presented from the STAR European Conference, and I'm going to spend the next slide, giving you a little bit more visibility on that data.

這將代表風險津貼的可能收益的主要來源，這將是我們向 FDA 提交 De Novo 申請的關鍵。我們還打算在提交的文件中包含支持性補充數據，其中包括 STAR 歐洲會議上提出的 CABG 期間去除替格瑞洛的真實世界證據，我將在下一張幻燈片中為您提供更多了解那個數據。

The completion of the technical files is leveraging the electronic eSTAR platform. And as already stated, we are on track for the FDA de novo submission in September, with Health Canada submission leveraging the same platform to follow sooner after. Just as a reminder to our listeners, DrugSorb-ATR is an FDA breakthrough designated device, which means that its submission will be associated with a priority review.

技術文件的完成是利用電子eSTAR平台。正如已經說過的，我們正按計劃於 9 月向 FDA 重新提交申請，加拿大衛生部將利用相同的平台稍後提交申請。提醒我們的聽眾，DrugSorb-ATR 是 FDA 突破性指定設備，這意味著其提交將與優先審查相關。

A recent analysis suggested that de novo applications of breakthrough designated devices have an estimated 25% faster review time lines compared to regular applications. And as such, pending the FDA agreement of the de novo pathway submissions and the associated priority review of the breakthrough status of the DrugSorb-ATR device, this means that we could have a potential FDA decision within six months to 12 months following submission.

最近的一項分析表明，與常規申請相比，突破性指定設備的從頭申請的審核時間預計將快 25%。因此，在 FDA 同意 de novo 途徑提交以及 DrugSorb-ATR 裝置突破狀態的相關優先審查之前，這意味著我們可能會在提交後 6 個月至 12 個月內做出 FDA 的潛在決定。

Next slide, please. Earlier this year, we had the privilege of being present and presenting on one of the largest conference in the world, the EuroPCR meeting that is held annually in Paris. During this meeting with over 12,000 attendees, data from our STAR registry was selected for an oral presentation. And at the end of the conference, Phil has already alluded to, the Scientific Committee awarded the STAR registry data a top five spot in their finalist -- as the finalist in their best scientific abstract competition.

請下一張投影片。今年早些時候，我們有幸參加了世界上最大的會議之一，即每年在巴黎舉行的 EuroPCR 會議。在這次有超過 12,000 名與會者參加的會議中，我們選擇了 STAR 註冊表中的資料進行口頭演示。Phil 已經在會議結束時提到，科學委員會將 STAR 註冊數據授予了決賽前五名——作為最佳科學摘要競賽的決賽入圍者。

So why do we show within the STAR registry that we believe is going to be a supportive piece to our regulatory submissions? As you know, removal of ticagrelor during cardiac surgery with cardiopulmonary bypass is an approved indication with CytoSorb since 2020 and is increasingly being used as standard of care in many heart centers in Europe. In the STAR registry, we are collecting high fidelity data of this everyday real-world use of a device for removal of ticagrelor.

那麼，為什麼我們要在 STAR 註冊中顯示我們認為這將成為我們向監管機構提交的支持性文件呢？如您所知，自 2020 年以來，自 2020 年起，CytoSorb 批准在體外循環心臟手術期間移除替格瑞洛，並且越來越多地被歐洲許多心臟中心用作護理標準。在 STAR 註冊表中，我們正在收集日常實際使用替格瑞洛去除裝置的高保真數據。

In the analysis, we had data from five different countries, 23 investigative sites, totaling 102 isolated CABG patients. This is a population that we have discussed previously will be the target intended population calculation for our submissions. So these patients were operated very soon since the last dose of ticagrelor on the mean of 22.8 hours.

在分析中，我們獲得了來自 5 個不同國家、23 個研究地點、總共 102 名孤立的 CABG 患者的數據。這是我們之前討論過的人口，將作為我們提交的目標預期人口計算。因此，這些患者在最後一次服用替格瑞洛後很快就接受了手術，平均時間為 22.8 小時。

Just as a reminder, guidelines recommend that these patients should wait for at least 72 hours, but with everyday practice, many times this is not feasible. So these patients were operated in a much shorter window compared to what the guidelines recommend.

提醒一下，指引建議這些患者應該等待至少 72 小時，但在日常實踐中，很多時候這是不可行的。因此，與指南建議的時間相比，這些患者的手術時間要短得多。

The device was used for an average of 1.5 hours during the CPB run of the operation, which is almost identical to the time that we saw in STAR-T, again, very, very comparable population and device use in these two data sets.

在 CPB 操作過程中，該設備平均使用了 1.5 小時，這與我們在 STAR-T 中看到的時間幾乎相同，這兩個資料集中的人口和設備使用情況非常非常相似。

What we did present in Paris was the fact that in the STAR registry, we observed bleeding rates that were substantially lower than those reported in the European CABG registry among patients on ticagrelor being operated either very early within 24 hours or later on within 24 to 72 hours, but always not having completed the recommended washout.

我們在巴黎展示的事實是，在STAR 登記中，我們觀察到接受替格瑞洛治療的患者的出血率大大低於歐洲CABG 登記中報告的出血率，這些患者要么在24 小時內很早進行手術，要么稍後在24 至72 小時內進行手術。

You can see the rates presented on the slide. And in fact, the more patients who waited for at least a day before being operated, you will see a substantial reduction or severe bleeding to very, very low rates equivalent to those so see in patients not operated or not anticoagulant having a CABG operation. Importantly, none of these sites are investigators reported any device-related adverse events.

您可以看到投影片上顯示的費率。事實上，在手術前至少等待一天的患者越多，您就會看到出血量大幅減少或嚴重出血率非常非常低，相當於未手術或未接受冠狀動脈旁路移植手術的患者中所見的情況。重要的是，這些網站的研究人員均未報告任何與設備相關的不良事件。

The data from the eCABG registry represent a very good benchmark for us to compare the rates from the STAR registry. And as such, as noted previously, this was very well received at the scientific conference, and we're very pleased to receive the designation as the top five finalist for best scientific abstract.

eCABG 登記處的數據為我們提供了一個非常好的基準來比較 STAR 登記處的比率。因此，如前所述，這在科學會議上受到了熱烈歡迎，我們很高興被指定為最佳科學摘要前五名決賽入圍者。

And with that, I would like to turn the call over to Vincent to give you a regulatory update.

說到這裡，我想將電話轉給文森特，為您提供最新的監管資訊。

Thank you, Makis. This is Vince Capponi, and good day to everybody. As Makis has mentioned, the de novo time line, we're in the final stages of assembling the technical file that will be submitted through the eSTAR program. At this point, we're -- I'm happy to say we're 75% complete with that file. We've concluded most of the engineering documentation and now starting to complete the clinical documentation for that submission.

謝謝你，馬基斯。我是文斯·卡波尼，祝大家美好的一天。正如 Makis 所提到的，從頭開始的時間線，我們正處於組裝將透過 eSTAR 計劃提交的技術文件的最後階段。至此，我很高興地說我們已完成該文件的 75%。我們已經完成了大部分工程文件，現在開始完成該提交的臨床文件。

Along with the submission in parallel, we are also working on preparing the Canadian submission, which we hope to have filed shortly after the eSTAR for FDA. It's very similar, so we believe we can do it in a relatively timely manner. Hopefully, also through the Canadian submission, generally speaking, Canadian approvals have generally in the past been a bit faster than US FDA approvals. But of course, we can't protect with 100% certainty, but we're hopeful that we will be able to be -- able to get a quick approval through Canada.

在並行提交的同時，我們也致力於準備加拿大的提交，我們希望在 eSTAR 向 FDA 提交後不久提交。非常相似，所以我們相信我們可以相對及時地做到這一點。希望透過加拿大的提交，一般來說，加拿大的批准在過去通常比美國 FDA 的批准要快一些。當然，我們無法 100% 確定提供保護，但我們希望能夠快速獲得加拿大的批准。

Next slide, please. Global from a regulatory standpoint as part of the preparation for the Canadian submission, we have completed the MDSAP audit, which is required for a Canadian submission. I'm happy to say that the audit went very well. It's currently under review by but we feel very confident that it will be approved for a submission to Canada through the MDSAP program.

請下一張投影片。從全球監管的角度來看，作為加拿大提交準備工作的一部分，我們已經完成了加拿大提交所需的 MDSAP 審核。我很高興地說審計進展順利。它目前正在接受審查，但我們非常有信心它會被批准透過 MDSAP 計劃提交給加拿大。

With respect to MDR, which affects obviously our European operations and Rest of World, we are targeting a December 2024 submission to our notified body and have already requested the MDR audit for June of 2025.

對於明顯影響我們歐洲業務和世界其他地區的 MDR，我們的目標是在 2024 年 12 月向我們的公告機構提交資料，並已要求在 2025 年 6 月進行 MDR 審計。

We're very confident based on our continued successful audits throughout the product life cycle of CytoSorb that we will be able to achieve the MDR audit, again, meeting all the requirements which are more extensive than the MDD, but we are very confident that we'll be able to achieve approval.

基於我們在 CytoSorb 整個產品生命週期中持續成功的審核，我們非常有信心我們將能夠再次實現 MDR 審核，滿足比 MDD 更廣泛的所有要求，但我們非常有信心就能獲得批准。

As Phil mentioned, the PuriFi pump registration was received in June, working with our partner, Medica. We were able to get that completed and able to receive the first 30 pumps. And we have the second order that will be coming in shortly here, and we are looking forward to, again, expanding that into the market.

正如 Phil 所提到的，我們與合作夥伴 Medica 合作於 6 月收到了 PuriFi 幫浦的註冊。我們最終完成了這項工作，並收到了前 30 台泵浦。我們很快就會收到第二份訂單，我們期待再次將其擴展到市場。

And as Phil mentioned, has received very, very good reception in the marketplace. On top of that, we've also received after over 1.5 years worth of effort registration in Taiwan, and we're looking forward to now opening up with that market.

正如菲爾所提到的，它在市場上受到了非常非常好的歡迎。除此之外，經過1.5年多的努力，我們還在台灣獲得了註冊，我們期待現在打開該市場。

With that, I'll turn it back to you, Phil.

這樣，我會把它轉回給你，菲爾。

Great. Well, thanks, Vince. This year, we have worked diligently to execute upon a broad turnaround strategy that is dependent on obtaining a number of key objectives. You've heard today that, one, our guidance that we continue to expect to submit to our marketing applications to US FDA and Health Canada for DrugSorb-ATR this quarter and have made excellent progress in parallel programs like MDSAP that are critical to commercialization, for example, in Canada.

偉大的。好吧，謝謝，文斯。今年，我們努力執行一項廣泛的扭虧為盈策略，該策略取決於實現一些關鍵目標。今天您已經聽說，第一，我們繼續期望本季度向美國 FDA 和加拿大衛生部提交 DrugSorb-ATR 的營銷申請，並在對商業化至關重要的 MDSAP 等並行項目中取得了出色進展，例如，在加拿大。

Secondly, we have strengthened our balance sheet with the addition of a new debt facility from Avenue Capital and believe that if we can hit our milestones, the $20 million in capital will get us to both Health Canada and FDA regulatory decisions.

其次，我們透過增加來自 Avenue Capital 的新債務融資來加強了我們的資產負債表，並相信如果我們能夠實現里程碑，2000 萬美元的資本將使我們能夠做出加拿大衛生部和 FDA 的監管決策。

Third, we remain extremely committed to cutting costs to drive efficiency and be self-sustaining. Importantly, you heard that we have made excellent progress in reducing our operating loss and expect to see additional benefit from our most recently completed cost cuts.

第三，我們仍然極度致力於削減成本以提高效率並實現自我維持。重要的是，您聽說我們在減少營運損失方面取得了巨大進展，並期望從我們最近完成的成本削減中看到額外的好處。

Fourth, our gross margins continue to be strong and are expected to expand as we grow the markets in Europe and certainly are expected to expand further if we are able to drive US FDA and Health Canada approval where the gross margins for DrugSorb-ATR are expected to be significantly higher than for CytoSorb.

第四，我們的毛利率持續保持強勁，隨著我們在歐洲市場的發展，毛利率預計會進一步擴大，如果我們能夠推動美國FDA 和加拿大衛生部的批准，預計DrugSorb-ATR 的毛利率預計會進一步擴大顯著高於 CytoSorb。

And lastly, we are -- have done a lot of work to try to increase our core CytoSorb sales growth beyond the 25 million devices that we've delivered to date. Finally, as you are aware, we have been positioning CytoSorbents for the next stage of growth, both our existing international franchise as well as the potential to open the US and Canadian markets. This is why it has taken us so long to find the right CFO candidate to replace our esteemed retiring CFO, Kathy Bloch.

最後，我們已經做了很多工作，試圖將我們的核心 CytoSorb 銷售成長提高到超過我們迄今為止交付的 2500 萬台設備。最後，如您所知，我們一直在為 CytoSorbents 的下一階段成長做好準備，包括我們現有的國際特許經營權以及打開美國和加拿大市場的潛力。這就是為什麼我們花了這麼長時間才找到合適的財務長候選人來接替我們尊敬的即將退休的財務長凱西·布洛赫 (Kathy Bloch)。

Kathy has gone above and beyond the call of duty, selflessly coming back from retirement last August, resumed her former full-time CFO role and in the intervening 12 months, helping to secure the future of the company with two key financings and orchestrating our cash conservation strategy. With her retirement announced today to capture an outstanding CFO career and will continue as a consultant to help manage the smooth transition, our newly appointed CFO, Peter Mariani.

凱西（Kathy）超越了職責範圍，去年8 月無私地退休，恢復了以前的全職首席財務官職位，並在接下來的12 個月內通過兩項關鍵融資和協調我們的現金幫助確保了公司的未來保護策略。我們新任命的財務長彼得·馬裡亞尼 (Peter Mariani) 今天宣布退休，以從事出色的財務長職業生涯，並將繼續擔任顧問，幫助管理平穩過渡。

On behalf of everyone at CytoSorbents, we thank Kathy for more than 11 years of dedication and leadership at the company as a trusted colleague and friend with so many contributions that have helped us achieve the success we have today and wish her an enjoyable relaxing and well-deserved retirement.

我們代表CytoSorbents 的全體員工，感謝Kathy 作為值得信賴的同事和朋友，在公司超過11 年的奉獻和領導，做出瞭如此多的貢獻，幫助我們取得了今天的成功，並祝她度過愉快的放鬆和健康-應得的退休。

With that, I'd like to turn the call over back to Kathy to have some final words. Kathy?

說到這裡，我想把電話轉回給凱西，最後說幾句話。凱西？

Thank you so much, Phil. I would like to take this opportunity to thank the Board of Directors, my colleagues on the management team and really all the employees of CytoSorbents for their support and collaboration, which have made my 11-year tenure as CFO still very enjoyable.

非常感謝你，菲爾。我想藉此機會感謝董事會、管理團隊的同事以及CytoSorbents的所有員工的支持和協作，這使我作為CFO的11年任期仍然非常愉快。

I especially want to thank the finance and accounting team members who have supported me in the US and in the EU, I'd like to thank you for your extraordinary dedication, talent and contributions to the company.

我特別要感謝在美國和歐盟支持我的財務和會計團隊成員，感謝你們對公司的非凡奉獻、才華和貢獻。

And I wish everyone, including our new CFO, Pete Mariani, the best of success as we head towards the exciting upcoming job of commercialization of DrugSorb-ATR in the United States. So thank you all so much.

我祝福每個人，包括我們的新任財務長 Pete Mariani，在我們即將開展的 DrugSorb-ATR 在美國商業化的激動人心的工作中取得最大成功。非常感謝大家。

Thank you, Kathy. And with that, I'd like to welcome Pete Mariani to the CytoSorbents team. Pete is a seasoned and accomplished medical device CFO, who has many successes at high-growth publicly traded companies such as Axogen, Hansen Medical and Guidant Corporation speak for themselves.

謝謝你，凱西。在此，我謹歡迎 Pete Mariani 加入 CytoSorbents 團隊。Pete 是一位經驗豐富、成就斐然的醫療器材首席財務官，他在 Axogen、Hansen Medical 和 Guidant Corporation 等高成長上市公司取得了許多成功，這不言而喻。

He has consistently demonstrated a disciplined and rigorous approach to financial management, operational excellence and strategic development, both domestically and internationally, that aligns perfectly with our next phase of expected rapid growth.

他在國內外財務管理、卓越營運和策略發展方面始終表現出紀律嚴明的方法，這與我們下一階段預期的快速成長完美契合。

Importantly, CytoSorbents today shares many similarities to Axogen when Pete joined as CFO in 2016, including with respect to its size, revenue base, US market opportunity and high-margin business model. He has proven his ability to fund, scale and manage impressive growth.

重要的是，如今的 CytoSorbents 與 Pete 於 2016 年加入擔任財務長時的 Axogen 有許多相似之處，包括規模、收入基礎、美國市場機會和高利潤商業模式。他已經證明了自己有能力資助、擴大規模和管理令人印象深刻的成長。

As we pursue US and Canadian marketing approval for DrugSorb-ATR and drive our OUS business with CytoSorb, we believe Pete will be an outstanding fit where his deep global experience and insight is expected to be vital to our success.

當我們尋求DrugSorb-ATR 在美國和加拿大的營銷批准並透過CytoSorb 推動我們的OUS 業務時，我們相信Pete 將是一個出色的人選，他深厚的全球經驗和洞察力預計將對我們的成功至關重要。

We are thrilled to have Pete joined CytoSorbents and be a key member of the management team. And in the coming months, we hope to reach out to many of you to introduce you firsthand to Pete.

我們很高興 Pete 加入 CytoSorbents 並成為管理團隊的關鍵成員。在接下來的幾個月裡，我們希望與你們中的許多人聯繫，向你們介紹皮特的第一手資料。

With that, let me have Pete stay a few words here as we wind up this call. Pete?

那麼，在我們結束這通通話時，請讓皮特在這裡說幾句話。皮特？

Thank you, Phil. I appreciate the warm welcome, I appreciate the trust of Board in creating this opportunity for me. It is great to be with all of you as investors today as well. I am excited to join CytoSorbents at this pivotal time in its history. I've had the great privilege to be part of some of the most significant advancements in medical technology over the years, including advancements in cardiac stents, cardiac rhythm management, medical robotics, laser cataract therapies and, of course, nerve repair.

謝謝你，菲爾。我感謝熱烈的歡迎，感謝董事會為我創造這個機會的信任。今天也很高興能與各位投資者在一起。我很高興能在 CytoSorbents 歷史上的這個關鍵時刻加入它。多年來，我非常榮幸地參與了醫療技術領域一些最重大的進步，包括心臟支架、心律管理、醫療機器人、雷射白內障治療，當然還有神經修復方面的進步。

CytoSorbents blood purification therapy is a natural extension of this [equipment], and I am looking forward to partner to further develop execute and scale our long-term growth strategy and bring improved (technical difficulty) hospitals. And of course, I look forward to meeting with many of you in the [near future].

CytoSorbents 血液淨化療法是該[設備]的自然延伸，我期待與合作夥伴進一步製定、執行和擴大我們的長期成長策略，並為醫院帶來改進（技術難度）。當然，我期待著與你們中的許多人會面[不久的將來]。

Thanks again, Phil.

再次感謝，菲爾。

Thanks very much, Pete. That concludes our prepared remarks. Operator, please open the call up for the Q&A session. Just let me remind you, as Pete has not officially started until tomorrow, he will not be participating in the Q&A session. Operator?

非常感謝，皮特。我們準備好的演講到此結束。接線員，請打開問答環節的電話。請允許我提醒您，由於 Pete 明天才正式開始，因此他不會參加問答環節。操作員？

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Michael Sarcone, Jefferies.

邁克爾·薩爾科內，杰弗里斯。

Hey, good afternoon and thanks for taking the questions. Just to start, congrats to both Kathy and Pete. Kathy has been great working with you. I hope you have a great retirement, and Pete, looking forward to working with you again. So -- all right.

嘿，下午好，感謝您提出問題。首先，恭喜凱西和皮特。凱西和你一起工作非常愉快。我希望您退休後生活愉快，皮特期待再次與您合作。那麼——好吧。

So I guess the first one for, I guess, for either Phil or Makis, you're on track with the FDA and Health Canada submission for DrugSorb. Can you just give us an update on how you're feeling about approval? Maybe can you give us an update on any conversations you've had with the regulators, particularly the FDA more recently?

所以我想第一個，我想，對於 Phil 或 Makis 來說，你們正在向 FDA 和加拿大衛生部提交 DrugSorb。您能為我們介紹一下您對批准的最新感受嗎？您能否向我們介紹一下您與監管機構（尤其是最近與 FDA）進行的任何對話的最新情況？

Thanks very much, Michael. Makis, would you like to take that?

非常感謝，麥可。馬基斯，你願意接受嗎？

Sure. And thanks, Michael, for the question. As we have discussed previously, we feel that the STAR-T pivotal trial does provide the necessary information to be able to execute the necessary benefit to risk analysis. And I think as we have highlighted in previous calls and stated during our own corporate webinars is that the STAR-T data has helped us identify more specifically, they intend to target population.

當然。謝謝邁克爾提出的問題。正如我們之前所討論的，我們認為 STAR-T 關鍵試驗確實提供了必要的信息，以便能夠執行必要的風險分析效益。我認為，正如我們在先前的電話會議中強調並在我們自己的企業網路研討會上指出的那樣，STAR-T 數據幫助我們更具體地確定了他們打算針對的目標群體。

And as we discussed before, we have identified that to be those patients undergoing a coronary artery bypass operation and also the intended potential benefit associated with the use of device. So in that regard, we believe that can -- as a standalone, can support a robust benefit or risk analysis.

正如我們之前所討論的，我們已經確定了那些接受冠狀動脈繞道手術的患者以及與使用該設備相關的預期潛在益處。因此，在這方面，我們認為，作為一個獨立的項目，可以支持穩健的效益或風險分析。

In addition, as I've shared today on the call, the accumulating evidence that is now captured systematically in the high-quality registry such as the STAR registry, we believe it will be an important supplement in our permutations with the agency.

此外，正如我今天在電話會議上分享的那樣，現在在 STAR 註冊表等高品質註冊表中系統捕獲的積累證據，我們相信這將是我們與該機構的排列中的重要補充。

Having said that, the -- anytime you submit an application, you have to wait for the review and the comments from the agency. We have not had any additional discussions with the agency since our last call. So there's no update on that front. But we do believe that the application will provide the necessary information for a very productive and collaborative interaction with the agency and to allow them to proceed with the necessary benefit to risk analysis.

話雖如此，無論何時您提交申請，您都必須等待該機構的審核和意見。自上次通話以來，我們尚未與該機構進行任何其他討論。所以這方面沒有更新。但我們確實相信，該應用程式將為與該機構進行非常富有成效和協作的互動提供必要的信息，並使他們能夠繼續進行風險分析，從而獲得必要的好處。

Got it. Thanks, Makis. So then maybe one or two for Kathy. Just on the gross margins. The press release today mentioned the line of sight to 80%. Can you talk about what gets us to 80% and what level of sales might get you there? And then just kind of the second part of that is more in the near term, how are you thinking about gross margins in the second half of '24?

知道了。謝謝，馬基斯。那麼凱西可能會遇到一兩個。只是在毛利率上。今天的新聞稿提到視線達到80%。您能談談是什麼讓我們達到了 80% 以及什麼水準的銷售可以讓您達到這個目標？第二部分更多的是短期內，您如何看待 24 年下半年的毛利率？

Yes. I think, actually, Michael -- okay, Kathy, go ahead, please.

是的。我想，實際上，邁克爾——好吧，凱西，請繼續。

Yes. So Michael, obviously, volume is going to -- any amount of volume growth is going to increase our product gross margins, and they should grow up very rapidly. I expect that at 15% to 20% year-over-year growth, we should see approaching 80% or at 80%. So it should be relatively straightforward. Of course, once we get approval in the US, the margins will be even higher. And then we would see like exceptional growth rates in our overall gross margins.

是的。所以邁克爾，顯然，銷量將會——任何數量的銷量增長都會增加我們產品的毛利率，而且它們應該會非常迅速地增長。我預計，在同比增長 15% 至 20% 的情況下，我們應該會看到接近 80% 或 80%。所以它應該是相對簡單的。當然，一旦我們在美國獲得批准，利潤率會更高。然後我們會看到我們的整體毛利率出現異常成長。

Got it. (multiple speakers) -- Sorry, go ahead.

知道了。 （多位發言者）－抱歉，請繼續。

I'm sorry, Michael. One of the people responsible for helping to drive our gross margins higher as Vince Capponi, our President and Chief Operating Officer. Maybe, Vince, you wanted to give a little commentary on how our manufacturing processes have improved and our confidence that we can get to that 80% on a blended basis.

對不起，麥可。我們的總裁兼營運長文斯·卡波尼 (Vince Capponi) 是負責幫助提高我們毛利率的人之一。也許，Vince，您想對我們的製造流程如何改進以及我們對混合基礎上達到 80% 的信心發表一些評論。

Thanks, Phil. So we did a lot of improvements in the last year in the operation. We've actually reduced the labor requirement by almost 30% in part of the operation filling processes to help offset some of the lower volumes that we've had. So with the improvements that we're continually making here, we expect that we're going to continue to see improving margins. But as Kathy said, it's really dependent upon the volume as well.

謝謝，菲爾。所以我們去年在營運上做了很多改進。實際上，我們已將部分灌裝作業流程中的勞動力需求減少了近 30%，以幫助抵消部分產量下降的影響。因此，透過我們不斷進行的改進，我們預計我們將繼續看到利潤率的提高。但正如凱西所說，這實際上也取決於音量。

I think the other thing we need to keep in mind is that as part of our controlling cost, we're actually lowering our inventories. We're doing that by slowing down the production so that we can conserve the cash as we go through the FDA approval.

我認為我們需要記住的另一件事是，作為控製成本的一部分，我們實際上正在降低庫存。我們透過放慢生產速度來做到這一點，這樣我們就可以在獲得 FDA 批准時節省現金。

So to Kathy's point, and when we get to the 15% to 20% growth rate, we certainly have line of sight to that 80-plus percent plus an approval, obviously, for DrugSorb-ATR with much higher ASPs than the current CytoSorb certainly contribute to that.

因此，就 Kathy 的觀點而言，當我們達到 15% 至 20% 的成長率時，我們當然會看到 80% 以上的成長率，而且顯然，DrugSorb-ATR 的 ASP 比目前的 CytoSorb 高得多。對此做出貢獻。

And it's also based on the mix the direct sales. The higher, if you will, gross margin direct sales versus distributor which are lower margins than direct. So Again, there's a lot of factors in that. But what we're doing is we are continuing to improve the operation.

而且它也是基於直銷的組合。如果你願意的話，直銷的毛利率比分銷商的毛利率更高，而分銷商的毛利率比直銷低。再說一次，這裡面有很多因素。但我們正在做的是繼續改進營運。

And again, it's going -- as Kathy mentioned, going to be very dependent upon volume, but we do have a number of cost improvements that we're slowly implementing in the process here to hopefully get us back to that 80% soon.

再說一遍，正如 Kathy 所提到的，這將非常依賴數量，但我們確實有一些成本改進，我們正在過程中慢慢實施，希望能讓我們很快回到 80%。

Great. Very helpful. Thanks for all the color.

偉大的。非常有幫助。感謝所有的顏色。

Thanks very much, Michael.

非常感謝，麥可。

Yuan Zhi, B. Riley.

袁志，B.萊利。

Congrats on a good quarter and thank you for taking our question. Kathy, congrats on the retirement, and Pete, welcome on board, exciting time for you to join here at CytoSorbents. Maybe Phil, start with you, can you provide more color what factors pushed the revenue to grow in second quarter? And do you see similar trends in 3Q and comment on the volume versus the price change will be helpful?

恭喜您取得了良好的季度業績，並感謝您提出我們的問題。凱西，恭喜退休，皮特，歡迎加入 CytoSorbents，這是您加入 CytoSorbents 的激動人心的時刻。也許菲爾，從你開始，你能提供更多的資訊是什麼因素推動了第二季的營收成長嗎？您是否認為第三季有類似的趨勢，並對成交量與價格變化進行評論會有所幫助嗎？

Yes. I think that in the second quarter, what we saw was strength in the distributor and partner channel. I think that it coincided a little bit with the launch of our PuriFi pump. And as we told you previously, the PuriFi pump is intended to help establish an infrastructure of blood purification capabilities in countries where they don't have well-established dialysis infrastructures.

是的。我認為在第二季度，我們看到的是經銷商和合作夥伴通路的實力。我認為它與我們的 PuriFi 泵的推出有點吻合。正如我們之前告訴您的，PuriFi 幫浦旨在幫助那些沒有完善透析基礎設施的國家建立血液淨化能力的基礎設施。

And so -- this typically is found in our distributor territories that are necessarily in Western Europe, for example, as with Germany and Italy and France and the UK and Spain, for example. So I think that particular channel was good. And our hope is that our third quarter, which is typically a seasonal quarter for us because of holidays in Europe, will be a respectable quarter.

因此，這通常出現在我們的經銷商區域，這些區域必然是西歐，例如德國、義大利、法國、英國和西班牙。所以我認為那個特定的頻道很好。我們希望第三季（由於歐洲假期而對我們來說通常是季節性季度）將是一個值得尊敬的季度。

Any comments on the volume versus the price change year over year?

對同比數量與價格變化有何評論？

As Vince mentioned, the transfer prices to distributors are typically lower than our ASPs to -- for direct sales. But on the other hand, we benefit from having a lower cost of distributor sales because we don't incur those direct costs of the sales force ourselves.

正如文斯所提到的，經銷商的轉讓價格通常低於我們的直接銷售平均售價。但另一方面，我們受益於較低的經銷商銷售成本，因為我們自己不會承擔銷售人員的直接成本。

That being said, our pricing has been fairly stable across the board, both in transfer pricing as well as in direct sale pricing as well. But what you'll see from Q2 results is that the distributor channel was stronger for this quarter.

話雖如此，我們的定價在轉讓定價和直銷定價方面都相當穩定。但從第二季的業績中您會看到，本季的分銷管道更加強勁。

Got it. And the following question is how will the delivery of PuriFi pump contributed to the revenue growth in 3Q, either itself or helping the sales of CytoSorbents territories without the infrastructure. Can you provide more color on that?

知道了。接下來的問題是，PuriFi 幫浦的交付將如何為第三季的營收成長做出貢獻，無論是本身還是幫助沒有基礎設施的 CytoSorbents 地區的銷售。你能提供更多的顏色嗎？

Yes. We have a different model for rolling out the PuriFi pump in different parts of the world. And I think, though, the thing to keep in mind is that we're not looking to necessarily make money on the PuriFi pump, right? This is very much the printer -- printer cartridge model, where the printers provided at relatively low cost with the goal of driving disposable revenues of the printer cartridge. This is very similar to our approach to the PuriFi pump.

是的。我們在世界不同地區推出不同的 PuriFi 幫浦型號。但我認為，要記住的是，我們不一定要透過 PuriFi 幫浦賺錢，對嗎？這就是印表機——印表機墨水匣模型，印表機以相對較低的成本提供，目標是推動印表機墨水匣的可支配收入。這與我們的 PuriFi 幫浦方法非常相似。

Again, the PuriFi pump is there to establish this infrastructure of the purification capabilities so that they can use more of our CytoSorb devices. And so I think moving forward, the goal is to really drive CytoSorb volume rather than a typical hardware company trying to drive sales from hardware, if that makes sense.

同樣，PuriFi 泵浦的作用是建立這種淨化能力的基礎設施，以便他們可以使用更多我們的 CytoSorb 設備。因此，我認為，展望未來，我們的目標是真正推動 CytoSorb 的銷量，而不是典型的硬體公司試圖透過硬體來推動銷售（如果這有意義的話）。

Yes. Got it. That's very helpful. Thank you.

是的。知道了。這非常有幫助。謝謝。

Sure.

當然。

Tom Kerr, Zacks Small-Cap Research.

Tom Kerr，Zacks 小型股研究公司。

Good afternoon, guys and congratulations to Kathy, and thanks for all your detailed explanations and quick response to questions, so I appreciate it. Can you clarify -- I'm unclear on the Canadian submission because originally, I thought it was going to be jointly. Now it's going to happen after the FDA submission. So it's a fourth quarter event. I'm sorry, I don't have the slides in front of me, but can you clarify when that is expected to be submitted to the Canadian authorities?

下午好，夥計們，祝賀凱西，感謝您的所有詳細解釋和對問題的快速答复，所以我很感激。你能否澄清一下——我不清楚加拿大提交的材料，因為最初我認為這將是聯合的。現在這將在 FDA 提交後發生。這是第四季的活動。抱歉，我面前沒有幻燈片，但您能否澄清一下預計何時將其提交給加拿大當局？

Yes. I think that what you heard us say today is that we expect to post of those submissions in the third quarter with the prioritization, of course, for the US FDA application. So I think that we remain on track to try to achieve that, but we certainly will be prioritizing the FDA submission first.

是的。我認為您今天聽到我們所說的是，我們預計將在第三季發布這些提交資料，當然，優先考慮美國 FDA 的申請。因此，我認為我們仍將努力實現這一目標，但我們肯定會首先優先考慮 FDA 的提交。

Okay. So it's possible the Canadian submission could roll in the fourth quarter, but that's not your goal, correct?

好的。所以加拿大的提交可能會在第四季度進行，但這不是你的目標，對嗎？

Yes. That's not the goal. And I think that we're reiterating our guidance of third quarter submission for both.

是的。那不是目標。我認為我們正在重申我們對兩者第三季提交的指導。

Okay. All right. Sorry, I misunderstood that. Couple of financial questions. The R&D down to $1.5 million. Is that just the comparison against the STAR-T trials a year ago or is there anything else in there?

好的。好的。抱歉，我誤會了。幾個財務問題。研發費用降至 150 萬美元。這只是與一年前的 STAR-T 試驗進行比較還是還有其他內容？

There a number of (multiple speakers) -- go ahead, Kathy. Kathy, you may be on mute, please go ahead.

有很多（多個發言者）——請繼續，凱西。凱西，您可能處於靜音狀態，請繼續。

Thanks, Phil. The largest impact is coming from the STAR-T trial completion. So we're not incurring those hospital costs and patient costs that are associated with the trial. There have also been -- there's also been a strong focus of our R&D efforts on exclusively grant-related activities where the costs of those personnel are funded through the grant.

謝謝，菲爾。最大的影響來自 STAR-T 試驗的完成。因此，我們不會承擔與試驗相關的醫院費用和病人費用。我們的研發工作也非常注重與補助金相關的活動，這些人員的費用是透過補助金來資助的。

So we have been prioritizing that making sure that, that is the focus of the team to try to cut down in any non-grant R&D costs, so both of those are contributing. But the highest impact is coming from the STAR-T trial being completed.

因此，我們一直優先確保團隊的重點是努力減少任何非撥款研發成本，因此兩者都做出了貢獻。但影響最大的是 STAR-T 試驗的完成。

Okay. The comparisons, right. So is that a good number to use for the second half of the year, $1.5 million per quarter?

好的。對比一下就對了那麼，每季 150 萬美元這個數字適合下半年使用嗎？

Yes.

是的。

Okay. One last big picture question for Phil or anybody. The Taiwan thing seems interesting. Can you talk about that and what the size of that business could be or could it be the next Germany? Is it that big enough of a market?

好的。菲爾或任何人的最後一個大問題。台灣的事情看起來很有趣。您能談談這個問題嗎？市場夠大嗎？

Yes. I think it remains to be seen. I mean, Taiwan is, as you may have read from the press release, a very large market and a big believer in blood purification. So from an opportunity standpoint, it's very exciting. We're working through a distributor in Taiwan currently.

是的。我認為這還有待觀察。我的意思是，正如您可能從新聞稿中讀到的那樣，台灣是一個非常大的市場，也是血液淨化的堅定信仰者。因此，從機會的角度來看，這是非常令人興奮的。目前我們正在透過台灣的經銷商進行合作。

And they, in fact, were helpful in getting the Taiwanese approval and registration. So time will tell to see how this will develop. And we are -- we have a lot of hopes for Taiwan, but it's just one of many countries where we're working to drive CytoSorb sales.

事實上，他們對獲得台灣的批准和註冊很有幫助。所以時間會告訴我們這將如何發展。我們對台灣寄予厚望，但這只是我們努力推動 CytoSorb 銷售的眾多國家之一。

Got it. Last financial question for me. You did receive the $15 million loan, right? It wasn't a subsequent event at the end of the quarter?

知道了。我的最後一個財務問題。你確實收到了那筆 1500 萬美元的貸款，對吧？這不是季度末的後續事件嗎？

We closed the financing at the last day of the quarter. So it was a Q2 event on the financing

我們在本季的最後一天完成了融資。所以這是第二季的融資事件

(multiple speakers) --

（多位發言者）——

In the second quarter, yes, that's correct.

在第二季度，是的，這是正確的。

Thank you. That's all I have for today.

謝謝。這就是我今天的全部內容。

Thanks, Tom.

謝謝，湯姆。

(Operator Instructions)

（操作員說明）

Sean Lee, H.C. Wainwright.

李，H.C.溫賴特。

Hey. Good afternoon, guys. Congrats to Kathy and hope wish you a happy retirement. And welcome, Pete. I look forward to working with you. Most of my key questions have been answered, but I'm just wondering, you were mentioning the doing R&D mostly on the grant.

嘿。下午好，夥計們。恭喜凱西，並祝您退休生活愉快。歡迎，皮特。我期待與您合作。我的大部分關鍵問題都已得到解答，但我只是想知道，您提到的研發工作主要是在撥款方面。

So I was wondering what are the major projects that you are working on in terms of the grant supported ones? I know previously you had worked on HemoDefend with I was wondering whether that's still going on and whether there are other projects or products that we can look forward to? Thanks.

所以我想知道您正在進行哪些受贈款支持的主要項目？我知道您之前曾參與過 HemoDefend 的工作，我想知道這是否還在繼續，是否還有其他我們可以期待的項目或產品？謝謝。

Sure. Thanks, Sean. Yes, the programs that -- R&D programs -- preclinical R&D programs that are being funded right now really are focused on HemoDefend-BGA and the use of HemoDefend-BGA in different form factors for either military, civilian or industrial usage. And I think that we're making excellent progress in that program. We continue to seek additional funding opportunities for that program. And we're getting very close, I believe, to human testing. So Vince, would you like to comment about the HemoDefend program?

當然。謝謝，肖恩。是的，目前正在資助的研發項目、臨床前研發項目確實專注於 HemoDefend-BGA 以及 HemoDefend-BGA 以不同形式用於軍事、民用或工業用途。我認為我們在該計劃中取得了巨大進展。我們繼續為該計劃尋求額外的資助機會。我相信，我們已經非常接近人體測試了。Vince，您想對 HemoDefend 計畫發表評論嗎？

Sure, Phil. Thanks. So Sean nice to hear from me. We've made quite a bit of progress on the HemoDefend-BGA, as Phil mentioned. Just a couple of different form factors that we're focused on to really get to what we think will be the most accessible markets, which would be the military and then ultimately, the civilian.

當然，菲爾。謝謝。肖恩很高興收到我的來信。正如 Phil 所提到的，我們在 HemoDefend-BGA 上取得了相當大的進展。我們只關注幾種不同的形式因素，以真正進入我們認為最容易進入的市場，即軍事市場，最終是民用市場。

So those programs are – there's two key programs that are funding that right now. We have a couple of other grants that are in preparation right now to extend that funding further into commercialization through funding of a clinical trial and ultimately scaling for commercialization.

所以這些計劃是——目前有兩個關鍵計劃正在為其提供資金。我們目前正在準備其他幾項撥款，透過資助臨床試驗並最終擴大商業化規模，將資金進一步擴展到商業化。

But as Phil mentioned, there are a number of different form factors, but really the two key form factors that we're pushing forward very aggressively are related to the military application and then also what would be at the point of collection, which, by the way, will feed into potentially the freeze-dried, if you will, plasma market, and we're working closely with a couple of people in that area as well, where we think we can provide some value. Thanks, Sean.

但正如 Phil 所提到的，有許多不同的外形尺寸，但實際上我們非常積極地推動的兩個關鍵外形尺寸與軍事應用有關，然後也與收集時的情況有關，透過這種方式，將進入潛在的凍乾血漿市場，如果你願意的話，我們也正在與該領域的一些人密切合作，我們認為我們可以在這個領域提供一些價值。謝謝，肖恩。

Thanks, Vince.

謝謝，文斯。

Great. Thanks for taking the questions.

偉大的。感謝您提出問題。

Thanks, Sean.

謝謝，肖恩。

(Operator Instructions) And with no further questions at this time, I would like to turn the call back over to Dr. Phillip Chan for any additional or closing remarks.

（操作員說明）目前沒有其他問題，我想將電話轉回給 Phillip Chan 博士，詢問任何補充或結束語。

Well, thank you, everyone, for joining the call today. If you do have any other questions, please feel free to reach out to me directly at cytosorbents.com while we manage this transition, and I'll hopefully be able to reply to your questions where possible. Have a great evening, everyone, and thank you very much. Good night.

好的，謝謝大家今天加入電話會議。如果您確實有任何其他問題，請隨時在 cytosorbents.com 上直接與我聯繫，同時我們將管理這一過渡，我希望能夠盡可能回答您的問題。祝大家有個愉快的夜晚，非常感謝。晚安。

And ladies and gentlemen, that concludes our conference for today. We thank you for your participation, and you may now disconnect.

女士們、先生們，我們今天的會議到此結束。我們感謝您的參與，您現在可以斷開連接。