Delcath Systems Inc (DCTH) 2023 Q1 法說會逐字稿

Good day and welcome to the Delcath Systems reports first quarter fiscal 2023 financial results call. (Operator Instructions) Please note that this event is being recorded.

美好的一天，歡迎參加 Delcath Systems 報告 2023 財年第一季度財務業績電話會議。 （操作員說明）請注意，該事件正在被記錄。

I would now like to turn the conference over to David Hoffman, General Counsel. Please go ahead.

我現在想將會議交給總法律顧問戴維·霍夫曼 (David Hoffman)。請繼續。

Thank you. And once again, welcome to Delcath Systems 2023 first-quarter earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development; Kevin Muir, General Manager of US Interventional Oncology; John Purpura, Chief Operating Officer; and Anthony Dias, Vice President of Finance.

謝謝。再次歡迎參加 Delcath Systems 2023 年第一季度財報電話會議。與我一起參加電話會議的是首席執行官杰拉德·米歇爾 (Gerard Michel)； Johnny John 博士，醫學事務和臨床開發高級副總裁； Kevin Muir，美國介入腫瘤科總經理；約翰·普爾普拉，首席運營官；和財務副總裁安東尼迪亞斯。

I'd like to begin the call by reading a Safe Harbor statement. This statement is made pursuant to the Safe Harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call with the exception of historical facts may be considered forward-looking statements within the meaning of Section 27(a) of the Securities Act of 1933 and Section 21(e) of the Securities Exchange Act of 1934.

我想在通話開始時閱讀一份安全港聲明。本聲明是根據 1995 年《私人證券訴訟改革法案》中描述的前瞻性聲明的安全港而做出的。除歷史事實外，本次電話會議中所做的所有聲明均可被視為第 27 條含義內的前瞻性聲明1933 年《證券法》(a) 和 1934 年《證券交易法》第 21(e) 條。

Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, those contained in subsequently filed quarterly reports on Form 10-Q, as well as in other reports that the company files from time to time with the Securities and Exchange Commission.

儘管該公司認為這些前瞻性陳述中反映的預期和假設是合理的，但不保證此類預期將被證明是正確的。由於各種風險和不確定性，實際結果可能與前瞻性陳述中明示或暗示的結果存在重大差異。對於可能導致實際結果與前瞻性陳述中明示或暗示的結果不同的此類風險和不確定性的討論，請參閱公司 10-K 表格年度報告中詳細說明的風險因素，以及隨後提交的季度報告中包含的風險因素。表格 10-Q 中的報告以及公司不時向美國證券交易委員會提交的其他報告中的報告。

Any forward-looking statements included in this earnings call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events, or circumstances.

本次財報電話會議中包含的任何前瞻性陳述僅在本次電話會議之日作出。我們不承擔更新或補充任何前瞻性陳述以反映後續知識、事件或情況的義務。

Now I would like to turn the call over to Gerard Michel. Gerard, please proceed.

現在我想把電話轉給杰拉德·米歇爾。杰拉德，請繼續。

Thank you, everyone, for joining today.

謝謝大家今天的加入。

Since filing the NDA resubmission on February 14th and receiving a notice on March 20th that FDA determined resubmissions constituted a complete Class II response, the company has been working with the agency on the review process of the August 14th PDUFA date approaches. This primarily entails a routine information request that would be expected during an NDA review. Since I know the question will be asked, at this time, we have received no indication about what the agency will schedule an advisory committee meeting. Of course, until we hear otherwise, we will continue to assume one will be scheduled.

自 2 月 14 日提交 NDA 重新提交並於 3 月 20 日收到 FDA 確定重新提交構成完整 II 級響應的通知以來，該公司一直在與該機構合作，對 8 月 14 日 PDUFA 日期臨近的審查過程進行合作。這主要需要 NDA 審查期間預期的例行信息請求。由於我知道會提出這個問題，因此目前我們還沒有收到有關該機構將安排諮詢委員會會議內容的任何信息。當然，在我們聽到其他消息之前，我們將繼續假設將會安排一場活動。

Given the recent financing and the approaching PDUFA date, we are accelerating our preparation for the commercial launch of Hepzato, if approved. Our commercial model to be comprised of referring oncologists and treating centers. Therefore, core part of that preparation is identification of potential commercial treating sites, which are sites that are trained in treating patients in the expanded access protocol prior to launch or committed to becoming trained within a few months after approval.

鑑於最近的融資和 PDUFA 日期的臨近，如果獲得批准，我們正在加快 Hepzato 商業推出的準備工作。我們的商業模式由轉診腫瘤科醫生和治療中心組成。因此，準備工作的核心部分是確定潛在的商業治療地點，這些地點是在啟動之前接受過擴展准入協議中治療患者培訓的地點，或承諾在批准後幾個月內接受培訓的地點。

As we have mentioned before, Delcath currently has three sites enrolled in the expanded access program with four more sites undergoing startup activities. In addition, approximately five other sites have expressed their intention in becoming treating sites if they have Hepzato Kits approved. So in total, we believe there are over 10 sites with the potential to become treating sites in a relatively short time frame post launch. While we will continue to seek additional treating sites, we believe this number of identified sites will ensure that we do not have treatment bottlenecks as referrals build from medical oncologists post-launch.

正如我們之前提到的，德爾卡思目前有 3 個站點加入了擴展訪問計劃，另外 4 個站點正在進行啟動活動。此外，大約另外五個站點也表示，如果 Hepzato 套件獲得批准，他們打算成為治療站點。因此，總的來說，我們認為有超過 10 個站點有可能在啟動後相對較短的時間內成為治療站點。雖然我們將繼續尋找更多的治療地點，但我們相信，隨著醫學腫瘤學家在推出後的轉診，這些已確定的地點將確保我們不會遇到治療瓶頸。

A second key component to successful launch is outreach to medical oncologists. Recall that the majority of our US investigators from the FOCUS trial were surgical oncologists. While we have a number of very supportive medical and metastatic ocular melanoma KOLs, we need a broader set of medical oncologists familiar with our data. Thus, we have started to build a medical affairs team and we will have MSLs out in the field by next month. Post launch, the MSLs will continue to focus on medical education with oncologists.

成功推出的第二個關鍵因素是與腫瘤內科醫生的聯繫。回想一下，FOCUS 試驗中我們的大多數美國研究人員都是外科腫瘤學家。雖然我們擁有許多非常支持的醫學和轉移性眼部黑色素瘤 KOL，但我們需要更多熟悉我們數據的醫學腫瘤學家。因此，我們已經開始組建醫療事務團隊，下個月我們將派出 MSL 到現場。啟動後，MSL 將繼續專注於腫瘤學家的醫學教育。

We have also begun recruiting for the sales force management team. The sales force will be bifurcated with one team focused on supporting the existing treatment centers and working out the new treatment centers, with the second team focused on calling on medical oncologists to facilitate potential referral of appropriate treatment patients to treatment sites.

我們還開始招聘銷售人員管理團隊。銷售隊伍將分為兩部分，一個團隊專注於支持現有的治療中心並製定新的治療中心，第二個團隊專注於呼籲腫瘤內科醫生幫助將適當的治療患者轉診到治療地點。

Turning to ongoing clinical work, because we have spoken about the preliminary CHOPIN results extensively on past few calls, I will review those results yet again. However, I will note that the independent investigators conducting that study have informed us that they are on track to publish a preplanned interim analysis by the end of this year. The analysis will include 40 of the planned 76 randomized patients comparing percutaneous hepatic perfusion with CHEMOSAT alone with percutaneous hepatic perfusion with CHEMOSAT plus 50 ipilimumab and nivolumab.

談到正在進行的臨床工作，因為我們在過去的幾次電話會議中廣泛討論了肖邦的初步結果，所以我將再次回顧這些結果。然而，我要指出的是，進行這項研究的獨立研究人員已通知我們，他們有望在今年年底前發布預先計劃的中期分析。該分析將包括計劃的 76 名隨機患者中的 40 名患者，將單獨使用 CHEMOSAT 的經皮肝灌注與使用 CHEMOSAT 加 50 伊匹單抗和納武單抗的經皮肝灌注進行比較。

Based on conversations with treating medical oncologists, we know there is strong interest in anticipation for these pending interim results given the signals seen in the small Phase 1 study and the prevalence of immune-oncology therapy in the treatment of metastatic ocular melanoma patients.

根據與治療醫學腫瘤學家的對話，我們知道，鑑於小型 1 期研究中看到的信號以及免疫腫瘤療法在治療轉移性眼部黑色素瘤患者中的流行，人們對這些懸而未決的中期結果抱有濃厚的興趣。

As previously reported on March 29th, the company closed a private investment and public equity deal with healthcare-focused institutional investors as well as investing existing investors that will provide up to $85 million in gross proceeds including approximately $25 million upfront funding. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners, Stonepine, and Serrado Capital, as well as existing investors including Rosalind Advisors. We are delighted to have the financial backing from these high-profile, healthcare-focused funds, and we believe the initial $25 million will be adequate to support the ongoing commercial launch preparations.

正如之前 3 月 29 日報導的那樣，該公司與專注於醫療保健的機構投資者以及現有投資者完成了一項私人投資和公共股權交易，該交易將提供高達 8500 萬美元的總收益，其中包括約 2500 萬美元的前期資金。本輪融資由 Vivo Capital 領投，Logos Capital、BVF Partners、Stonepine 和 Serrado Capital 以及 Rosalind Advisors 等現有投資者跟投。我們很高興能得到這些備受矚目的、專注於醫療保健的基金的財務支持，我們相信最初的 2500 萬美元將足以支持正在進行的商業發布準備工作。

The previously mentioned financing will trigger another $35 million for gross proceeds upon approval and then another $25 million in gross proceeds [of pipeline], achieving $10 million of quarterly revenue. In addition, we announced that we had reached an agreement with Avenue Capital to resume the interest-only period on the [average] loan from March 31, 2023 to September 30, 2023, deferring approximately $4.3 million of principal payments.

前述融資一旦獲得批准，將引發另外 3500 萬美元的總收益，然後再產生 2500 萬美元的總收益，從而實現 1000 萬美元的季度收入。此外，我們還宣布，我們已與 Avenue Capital 達成協議，恢復[平均]貸款的只還息期，從 2023 年 3 月 31 日到 2023 年 9 月 30 日，推遲約 430 萬美元的本金支付。

Together, these two financial transactions have greatly enhance our ability to appropriately fund launch preparations and should eliminate any perception of a financing overhang, which often tender share price appreciation upon product approvals.

這兩筆金融交易共同極大地增強了我們為上市準備工作提供適當資金的能力，並應消除任何融資過剩的感覺，這種融資過剩往往會在產品批准後導致股價升值。

I look forward to taking questions in a moment. But first, I will turn the call over to Tony to review the financials. Tony?

我期待著稍後回答問題。但首先，我會將電話轉給托尼，讓他審查財務狀況。托尼？

Thank you, Gerard.

謝謝你，杰拉德。

As stated in our earnings release, we're in the process of completing our customary year-end close and review procedures, including certain valuation work associated with the issuance of the warrants and stock -- preferred stock in Delcath's previously announced private placement that closed on March 29, 2023, and for the quarter ended March 31, 2023. Delcath's full first quarter 2023 financial results will be reflected in the quarterly report on Form 10-Q, which will be filed no later than May 22, 2023.

正如我們在財報中所述，我們正在完成慣例的年終結算和審查程序，包括與發行認股權證和股票相關的某些估值工作——Delcath 先前宣布的已完成私募的優先股2023 年 3 月 29 日以及截至 2023 年 3 月 31 日的季度。Delcath 2023 年第一季度的完整財務業績將反映在 10-Q 表格的季度報告中，該報告將不遲於 2023 年 5 月 22 日提交。

Revenues is expected to be approximately $600,000 for the three months ended March 31, 2023, compared to $378,000 for the three months ended March 31, 2022. The estimated increase in product revenue was due to the transition to direct sales in Europe, which occurred in March 2022, as well as an approximately 37% increase in unit volume. For the three months ended March 31, 2023, research and development expenses is expected to be relatively flat as compared to $4.5 million for both periods compared to the three months ended March 31, 2022.

截至 2023 年 3 月 31 日止三個月的收入預計約為 600,000 美元，而截至 2022 年 3 月 31 日止三個月的收入為 378,000 美元。產品收入的估計增長是由於歐洲向直接銷售的過渡，該過渡發生在2022 年 3 月，單位數量增加約 37%。截至2023年3月31日止的三個月，與截至2022年3月31日止的三個月相比，兩個時期的研發費用預計將相對持平，均為450萬美元。

As of March 31, 2023, the company had cash, cash equivalents, and restricted cash totaling $24.3 million as compared to cash, cash equivalents, and restricted cash totaling $11.8 million as of December 31, 2022. The increase in cash at $12.5 million was due to proceeds from the private placement which closed on March 29, 2023, offset by the use of $4.3 million of cash and operating activities and $6.3 million of principal payments towards the company's existing loan with Avenue.

截至 2023 年 3 月 31 日，該公司的現金、現金等價物和限制性現金總額為 2,430 萬美元，而截至 2022 年 12 月 31 日，現金、現金等價物和限制性現金總額為 1,180 萬美元。現金增加 1,250 萬美元是歸因於 2023 年 3 月 29 日結束的私募募集資金，被使用 430 萬美元現金和經營活動以及公司現有 Avenue 貸款的 630 萬美元本金支付所抵消。

That concludes my financial remarks. I'll ask the operator to open the phone lines for Q&A. Can you please check for questions?

我的財務評論到此結束。我會要求接線員打開電話線路進行問答。您能檢查一下有問題嗎？

(Operator Instructions) Yale Jen, Laidlaw & Company.

（操作員說明）Yale Jen，Laidlaw & Company。

Good morning and thanks for taking my questions and congrats on all the progress. I've got two hear. One is that given you guys already have -- will have more cash, any thoughts or any plans in the pipeline development? And then I have follow-up questions.

早上好，感謝您提出我的問題，並祝賀所有的進展。我有兩個聽到了一是考慮到你們已經擁有——將會有更多的現金，在管道開發方面有什麼想法或計劃嗎？然後我還有後續問題。

Yeah. We're going to restrict our pipeline activities to probably advisory committee meetings for the time being. I think our primary focus is a successful launch. With that said, there will be activity in parallel going on with care, but I don't see any significant in the actual clinical dosing patients probably until sometime next year.

是的。我們將暫時將我們的管道活動限制在顧問委員會會議上。我認為我們的首要重點是成功發布。話雖如此，將會有與護理同時進行的活動，但我可能要到明年某個時候才能在實際臨床劑量患者中看到任何顯著的變化。

Now with that said, we are prepared to support investigator-initiated trials as they are put in front of us by interested oncologists. And we're hopeful that we'll have a number of those started probably later this year, whether it's additional combination trials with immuno-oncology agents or trials in other indications. But next year, without a doubt, we will be running trials in other indications, both other tumor types and the likely other indications combined with immuno-oncology agents.

話雖如此，我們準備支持研究者發起的試驗，因為這些試驗是由感興趣的腫瘤學家擺在我們面前的。我們希望今年晚些時候能夠啟動一些試驗，無論是免疫腫瘤藥物的額外聯合試驗還是其他適應症的試驗。但明年，毫無疑問，我們將針對其他適應症進行試驗，包括其他腫瘤類型以及可能與免疫腫瘤藥物相結合的其他適應症。

Okay. Great. That's very, very helpful. And then maybe one more question here which is, one of the competitors, I think, recently reported that their study is in the ocular melanoma both in the first line as well as in the broadline. Any thoughts, any comments on whether what type of possible sort of competition may happen or not happen, any color with that?

好的。偉大的。這非常非常有幫助。然後也許還有一個問題，我認為其中一個競爭對手最近報告說，他們的研究涉及眼部黑色素瘤，無論是一線還是寬線。關於哪種類型的可能的競爭可能發生或不發生有什麼想法、評論嗎？有什麼顏色嗎？

I think you're referring to [Idea's] data, which I thought was quite good myself. Their ORR and duration of response looks more like in the realm of what we're seeing with our crowd. I think what's important to note is two things. One, patients -- most patients go through more than one line of therapy. The second thing is most medical oncologists treat this disease, believe patients should get both a systemic therapy as well as a local regional therapy. The latter, of course, is what we offer. So I don't see additional systemic therapies coming out as being a direct competitor with us.

我想你指的是[Idea的]數據，我自己認為這非常好。他們的 ORR 和反應持續時間看起來更像是我們在人群中看到的情況。我認為值得注意的是兩件事。第一，患者——大多數患者都會接受不止一種治療。第二件事是大多數腫瘤內科醫師治療這種疾病，認為患者應該同時接受全身治療和局部治療。當然，後者是我​​們提供的。因此，我不認為其他系統療法會成為我們的直接競爭對手。

I think the question is what goes first, systemic or a local regional therapy. I think more data needs to be generate to determine really what's best for the patients. I would note that most of these patients, when they do succumb to the disease, it is usually due to liver failure from liver mets. So I know that will be a place for us at some point for most of these patients.

我認為問題是先進行全身治療還是局部治療。我認為需要生成更多數據才能真正確定什麼對患者最有利。我要指出的是，大多數患者在死於這種疾病時，通常是由於肝代謝綜合徵導致的肝功能衰竭。所以我知道，在某個時候，對於大多數患者來說，這將是我們的一個地方。

Swayampakula Ramakanth, H.C. Wainwright.

斯瓦安帕庫拉·拉瑪坎特 (Swayampakula Ramakanth)，H.C.溫賴特。

Thank you. This is RK from H.C. Wainwright. And good morning, Gerard. A couple of quick questions from me too. In terms of the EAP program that's being run, could you give us an idea of how many patients have been treated so far or being treated under this program? And also, any commentary on the experience so far from both physicians and the patients?

謝謝。我是 H.C. 的 RK。溫賴特。早上好，杰拉德。我也問了幾個簡單的問題。就正在運行的 EAP 計劃而言，您能否告訴我們到目前為止有多少患者已經接受治療或正在該計劃下接受治療？另外，醫生和患者對迄今為止的經歷有何評論？

Yeah. So right now, well over, I think they had 40 patients at the start of this year, so they're probably well past the 40 at this point, I don't have a precise number. I had to guess based on the pace -- the pace and it's an estimate for me, it's probably somewhere in the range of 50 patients out of the 76 that need to be treated.

是的。所以現在，我認為他們在今年年初有 40 名患者，所以現在可能已經超過 40 名了，我沒有確切的數字。我必鬚根據速度進行猜測——速度，這對我來說是一個估計，76 名患者中可能有 50 名需要治療。

It is a randomized trial or is that the primary endpoint -- well, objective response rate is what we reported in the interim data and they're not sharing those results with us as time goes on. Of course, that's inappropriate. They should not share that with us. All I can say is we're very hopeful to say that the signal that was seen in this small number of patients, seven patients early on, will continue to hold, but we'll have to wait.

這是一項隨機試驗，或者說是主要終點——客觀緩解率是我們在中期數據中報告的結果，隨著時間的推移，他們不會與我們分享這些結果。當然，這是不合適的。他們不應該與我們分享這一點。我只能說，我們非常有希望地說，早期在這少數患者（七名患者）中看到的信號將繼續保持，但我們必須等待。

If we turn to the seven patients, they tolerated the sequential treatments quite well, medically through any toxicities that the physicians didn't think they could handle or that would be undue to the patients. So that was a very important issue to start with. And again, I talked about before, very, very high response rates, 100% disease control, 86%, I think, response rate, and 2.5 year roughly of duration of response and the PFS or acute PFS at the last data cut. So fingers crossed that that level of response and duration can be held with the larger end, and we get the interim data later this year.

如果我們轉向這七名患者，他們對連續治療的耐受性很好，從醫學上講，他們能夠忍受醫生認為他們無法處理的任何毒性，或者對患者來說不適當的毒性。所以這是一個非常重要的問題。再說一次，我之前談到過，非常非常高的緩解率，100% 的疾病控制，我認為是 86% 的緩解率，大約 2.5 年的緩解持續時間以及上次數據削減時的 PFS 或急性 PFS。因此，祈禱較大的一端能夠保持這種響應水平和持續時間，我們將在今年晚些時候獲得中期數據。

Fantastic. And then it's encouraging that you're getting more centers signing up for getting ready to adopt when Hepzato becomes approved. So at this point, what do you think is the market in terms of like number of centers who regularly do liver-directed therapies which can be -- I don't know if you're kind of dividing the market into different tiers as like some early adopters and adopters that you have to work on to gain their confidence and start using Hepzato.

極好的。令人鼓舞的是，當 Hepzato 獲得批准時，越來越多的中心報名准備採用。因此，在這一點上，您認為定期進行肝臟定向治療的中心數量是多少，我不知道您是否將市場分為不同的層次一些早期採用者和採用者，您必須努力贏得他們的信任並開始使用 Hepzato。

In terms of the number of centers that do liver-directed therapy, I don't know the precise number. It's at least in the hundreds. If we look -- think about TACE and Y90, which are the two primary liver-directed therapies. For this particular indication, we have no need, nor would it be prudent to try to get it to any meaningful percentage of that.

至於進行肝臟定向治療的中心數量，我不知道確切的數字。至少有數百個。如果我們看一下 - 想想 TACE 和 Y90，這是兩種主要的肝臟定向療法。對於這個特定的跡象，我們沒有必要，也不會謹慎地嘗試將其達到任何有意義的百分比。

I think if we had 10 centers up and running within three to six months or within three months, let's say, of launch, that would be fantastic. I can't see it ever going past and this number might flex down or up, but I can't see it going much past 20 centers. Maybe 25 at peak. The reason for that is we want to keep close tabs up these training centers, and again, recall that it is only about -- well, it's hard to say, but we're saying -- some people say we're conservative, but we're saying our candidate or patients -- I don't want to have a center doing one of these every three months. I'd like to see centers doing at least two a month just to make sure they're well trained, the team is up to speed.

我認為，如果我們在三到六個月內或在啟動後三個月內建立並運行 10 個中心，那就太棒了。我看不到它會過去，這個數字可能會上下波動，但我看不到它會超過 20 個中心。高峰期可能25歲。原因是我們想要密切關注這些培訓中心，再次提醒您，這只是——嗯，很難說，但我們要說——有些人說我們很保守，但是我們說的是我們的候選人或患者——我不想讓一個中心每三個月做一次這樣的事情。我希望看到中心每月至少進行兩次，以確保他們訓練有素，團隊能夠跟上進度。

So again, I think 25 at the most peak. I'm very happy with 10, one to two quarters post launch. If we can accomplish that, that will mean a phenomenal launch that we have the referrals up the pipeline to support that -- to support those centers.

再說一次，我認為最高峰是25歲。我對發布後 10、一到兩個季度感到非常滿意。如果我們能夠實現這一目標，這將意味著我們將有大量轉介來支持這一目標——支持這些中心。

Bill Maughan, Canaccord Genuity.

比爾·莫恩，Canaccord Genuity。

Good morning, and thanks. So of the initial dozen or so sites that are either currently online or have expressed interest, do you have a sense of how many patients they represent? And then second question, are you at the point yet where you can have even preliminary discussions with payers? Do you have any sense of how they go onboard payment for Hepzato as it launches or any sort of timeline on that? Thanks.

早上好，謝謝。那麼，在目前在線或表示有興趣的最初十幾個網站中，您知道它們代表了多少患者嗎？第二個問題，你是否已經到了可以與付款人進行初步討論的程度了？您知道 Hepzato 推出時他們是如何進行付款的嗎？或者有什麼時間表嗎？謝謝。

Sure. I'll let me handle that first part of the question in terms of how many they represent, then Kevin, I'm going to ask you to talk through on kind of the dynamics with hospitals and reimbursement in a moment.

當然。我會讓我來處理問題的第一部分，即他們代表了多少人，然后凱文，我稍後會請你談談醫院和報銷的動態。

In terms of the number of patients they represent. Shooting from the hip, maybe 30% of those 10, maybe 40. The biggest were -- that surprisingly focused on centers that already have a set of patients. But that's not really -- that's only part of the equation. The other part of the equation is going out to medical oncologists. We're not intending to open sites and getting the route to refer to these treating sites. That's the other part of the equation.

就他們所代表的患者數量而言。從臀部開始，這 10 個中可能有 30%，也可能有 40 個。其中最大的一個是——令人驚訝的是，它集中在已經有一組患者的中心。但事實並非如此——這只是等式的一部分。等式的另一部分是交給腫瘤內科醫生。我們不打算開放站點並獲取前往這些治療站點的路線。這是等式的另一部分。

Now, the reason -- what we have to make sure for both parts of that kind of equation is for treating sites -- some sites might not be able to do more of than one -- two a month. Others might be able to do eight a month. It varies. But if we assume that four a month is the average, so if you think about one a week probably will be an average per sites. If we assume that, then 15, 20 sites is more than enough to generate several hundred million dollars' worth of revenue. But the key to that is getting the patients referred to those three sites. Again, as I said before, we don't want sites that do one every two months. Ideally, we'd have a site doing about four a month.

現在，原因是——我們必須確保這種等式的兩個部分都是為了處理站點——有些站點可能不能做超過一個——每月兩個。其他人可能每個月可以做八次。它有所不同。但如果我們假設平均每月四個，那麼如果您考慮每週一個，則可能是每個站點的平均值。如果我們假設的話，那麼 15、20 個網站就足以產生數億美元的收入。但關鍵是讓患者轉診到這三個站點。再次強調，正如我之前所說，我們不希望網站每兩個月更新一次。理想情況下，我們的網站每月大約有四個。

This concludes our question-and answer-session. I would like to turn the call --

我們的問答環節到此結束。我想轉接電話——

Hang on. Kevin, can you chime in on the reimbursement for the hospitals and dynamics?

不掛斷。凱文，你能談談醫院的報銷和動態嗎？

Yeah, I can. Over the past period of time, we have done some significant market research with the payers. And so far, through that market research we've been, we think our strategy is prudent. We have a market access team in place, and we are prepared to handle the questions that we get. The true outreach to the payers will happen shortly upon approval when we are taking our EAP patients and converting them from clinical patients to commercial payments.

是的，我可以。在過去的一段時間裡，我們對付款人進行了一些重要的市場調查。到目前為止，通過我們所做的市場研究，我們認為我們的策略是謹慎的。我們有一個市場准入團隊，我們準備好處理我們收到的問題。當我們接受 EAP 患者並將他們從臨床患者轉變為商業付款時，真正接觸付款人的工作將在獲得批准後不久發生。

So I guess, from a market access or from a market research standpoint, we think we have a sound strategy. We've talked to some of the payers, but we'll see how that -- we will -- and we're confident that when we take those payers -- or I mean, the patients from clinical to commercial, the strategy will prove itself out.

所以我想，從市場准入或市場研究的角度來看，我們認為我們有一個合理的策略。我們已經與一些付款人進行了交談，但我們會看到如何 - 我們會 - 並且我們有信心，當我們接受這些付款人 - 或者我的意思是，患者從臨床到商業時，該策略將證明自己。

Yeah, I think we've got more avenues -- the majority of the patients will be out patients, correct?

是的，我認為我們有更多的途徑——大多數病人都是出院病人，對嗎？

Yes.

是的。

So the reimbursement will be under a C code, correct? Initially?

那麼報銷將採用 C 代碼，對嗎？最初？

Initially, we'll start with the traditional path of a C code and hopefully go to a J code shortly after.

最初，我們將從 C 代碼的傳統路徑開始，並希望不久之後轉向 J 代碼。

Right, so for the majority of patients, it will be a pass-through expense.

是的，所以對於大多數患者來說，這將是一筆轉嫁費用。

Yes.

是的。

And given this is an ultra-orphan product, the minority of patients that may end up being treated on in-patient basis, I think they need to stay an extra night past the single night. What our hub services told us is that given the small number of patients here and the fact that these are very sophisticated academic centers we're working with, they probably -- it's not going to be an issue of bundled payments. We'll be able to maneuver through that. But again, the bulk of these patients will be on out-patient patients, so the pass through.

鑑於這是一種超級孤兒產品，少數患者最終可能會接受住院治療，我認為他們需要在過夜後多住一晚。我們的中心服務告訴我們，鑑於這裡的患者數量很少，而且我們正在合作的這些都是非常複雜的學術中心，他們可能不會出現捆綁付款的問題。我們將能夠解決這個問題。但同樣，這些病人大部分都是門診病人，所以就通過了。

This concludes our question-and-answer session. I would like to turn the conference back over to Gerard Michel for any closing remarks.

我們的問答環節到此結束。我想將會議轉交給杰拉德·米歇爾（Gerard Michel）發表閉幕詞。

Yeah, I just wanted to thank everyone for taking the time this morning to listen in and we have got a lot of work ahead of us since we prep for launch, but we're going to keep our heads down and push forward. And thanks again for the support. Have a great day.

是的，我只是想感謝大家今天早上抽出時間來聆聽，自從準備發布以來，我們還有很多工作要做，但我們將低著頭繼續前進。並再次感謝您的支持。祝你有美好的一天。

Conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。