Delcath Systems Inc (DCTH) 2023 Q3 法說會逐字稿

Good day and welcome to the Delcath Systems reports third-quarter fiscal year 2023 financial results. All participants will be in listen-only mode. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, General Counsel. Please go ahead, sir.

美好的一天，歡迎閱讀 Delcath Systems 報告 2023 財年第三季財務業績。所有參與者將處於僅聽模式。 （操作員說明）今天的演示結束後，將有機會提問。 （操作員說明）請注意此事件正在被記錄。我現在想將會議交給總法律顧問戴維霍夫曼 (David Hoffman)。請繼續，先生。

Thank you. And once again, welcome to Delcath Systems 2023 third-quarter earnings and business update call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Senior Vice President of Finance; Kevin Muir, General Manager, Interventional Oncology; Vojo Vukovic, the Chief Medical Officer; and John Purpura, Chief Operating Officer.

謝謝。再次歡迎參加 Delcath Systems 2023 年第三季財報與業務更新電話會議。與我一起參加電話會議的是執行長 Gerard Michel； Sandra Pennell，財務資深副總裁； Kevin Muir，介入性腫瘤學總經理； Vojo Vukovic，首席醫療官；和營運長 John Purpura。

I'd like to begin the call by reading the 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, are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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.

我想透過閱讀安全港聲明來開始通話。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。本次電話會議中所做的所有聲明，除歷史事實外，均被視為第1 節意義內的前瞻性聲明。1933 年證券法第27A 條和 1934 年證券交易法第21E 條。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。

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 statement, 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.

由於各種風險和不確定性，實際結果可能與前瞻性聲明中明示或暗示的結果有重大差異。有關此類風險和不確定性的討論可能導致實際結果與前瞻性聲明中明示或暗示的結果有所不同，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 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. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

本次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。現在，我想將電話轉給傑拉德·米歇爾。杰拉德，請繼續。

Thank you, everyone, for joining today. Since the FDA approval of HEPZATO KIT on August 14 for patients with metastatic uveal melanoma, we have been focused on outreach potential treating sites and building our commercial team in preparation for commercial launch, which is now anticipated for January. While it has taken slightly longer than expected to work with our CMOs to finalize the produce, QC-released, labeled, and packaged melphalan specific to HEPZATO, we have been productively using the time between approval and launch to expand the number of treatment teams that have undergone by doctor training and attended a preceptorship, both of which required before new treating team can perform their first proctored case.

謝謝大家今天的加入。自8 月14 日FDA 批准HEPZATO KIT 用於治療轉移性葡萄膜黑色素瘤患者以來，我們一直專注於拓展潛在的治療地點並建立我們的商業團隊，為商業上市做準備，目前預計將於1 月上市。雖然與我們的 CMO 合作最終確定 HEPZATO 專用的產品、QC 放行、標籤和包裝的馬法蘭所需時間比預期稍長，但我們一直有效地利用批准和上市之間的時間來擴大治療團隊的數量，接受過醫生培訓並參加了指導，這兩者都是新治療團隊可以執行其第一個指導病例之前所必需的。

Since HEPZATO KIT's FDA approval, we have been encouraged by both the medical oncologist and interventional radiology communities' motivation and stated commitment to incorporate HEPZATO KIT into their practices treating patients with metastatic uveal melanoma. While we are fielding interest from more than 20 sites, we are primarily focused on a subset of these to ensure that we achieve our planned activation targets throughout the year. In conjection with the local medical oncologist at each of our target sites, we have been working with the sites interventional radiologists to identify and train HEPZATO KIT treatment teams.

自 HEPZATO KIT 獲得 FDA 批准以來，我們受到腫瘤內科醫生和介入放射學界的積極性的鼓舞，並承諾將 HEPZATO KIT 納入他們治療轉移性葡萄膜黑色素瘤患者的實踐中。雖然我們吸引了 20 多個站點的興趣，但我們主要關注其中的一部分，以確保我們實現全年計劃的激活目標。與我們每個目標站點的當地腫瘤內科醫生共同合作，我們一直在與站點的介入放射科醫生合作，以確定和培訓 HEPZATO KIT 治療團隊。

In addition to training the treatment teams at each site, we are also working to get HEPZATO KIT approved through the various traditional hospital defendant formularies and value analysis committees and we have started that process in 13 hospitals. Currently, we have three EAP sites: Moffitt Cancer Center, Duke University, and the University of Tennessee, which are fully trained, they can start treating commercial patients upon the availability of commercial product. In addition, we now have a further four sites: Mayo Clinic, Thomas Jefferson, Ohio, State University, and Stanford University that have completed the necessary steps to conduct their first commercial treatment under the guidance of a proctor, once commercial product is available and formulary and value analysis committee approvals are obtained.

除了培訓每個地點的治療團隊外，我們還努力讓 HEPZATO KIT 通過各個傳統醫院被告處方集和價值分析委員會的批准，我們已經在 13 家醫院啟動了這項流程。目前，我們有三個EAP站點：莫菲特癌症中心、杜克大學和田納西大學，這些站點經過充分培訓，可以在商業產品上市後開始治療商業患者。此外，我們現在還有另外四個中心：梅奧診所、托馬斯·傑斐遜、俄亥俄州、州立大學和史丹佛大學，這些中心已經完成了必要的步驟，一旦商業產品可用，就可以在監考人員的指導下進行首次商業治療。獲得公式和價值分析委員會的批准。

Beyond those seven sites, another four sites: UCLA, Providence St. John's, Mass General, and Piedmont hospital, currently have the preceptorship scheduled in November or December. In total, we expect at least 10 sites will have completed the required training to treat a commercial case by the end of January, contingent on scheduling a proctor team for that first case and a successful completion of the various value analysis committee processes. Given the need for the first case to be proctored and the required committee approvals, I don't expect all of the 11 previously mentioned sites to be actively treating patients in the first quarter. However, based on interest and progress to date, I am confident that we will achieve at least five active treatment sites sometime in the first quarter, 10 by the end of the second quarter, and 15 treating centers by the end of 2024.

除了這七個地點之外，另外四個地點：加州大學洛杉磯分校、普羅維登斯聖約翰醫院、麻省總醫院和皮埃蒙特醫院，目前計劃在 11 月或 12 月進行院長培訓。總的來說，我們預計至少 10 個地點將在 1 月底之前完成處理商業案例所需的培訓，具體取決於為第一個案例安排一個監考團隊以及成功完成各種價值分析委員會流程。鑑於需要對第一個病例進行監督並獲得委員會的批准，我預計前面提到的所有 11 個站點不會在第一季積極治療患者。然而，根據迄今為止的興趣和進展，我相信我們將在第一季的某個時候建立至少 5 個活躍治療中心，到第二季末建立 10 個治療中心，到 2024 年底建立 15 個治療中心。

We expect treatments per site to start out at approximately one per month and end the year at approximately two per month. Since HEPZATO KIT is a liver-directed interventional radiology procedure and not an infused drug, we are focused on medical centers as currently mentioned, that currently offer liver-directed therapies for metastatic uveal melanoma patients and currently treat a meaningful number of patients for liver-directed therapy. Noteworthy centers include Thomas Jefferson University, led by uveal melanoma oncologist thought leader, Marlana Orlof; and interventional radiologist, David Eschelman, a leader in liver-directed therapy. Thomas Jefferson by far treats the largest number of metastatic uveal melanoma patients in the country.

我們預計每個站點的治療開始時大約每月一次，年底大約每月兩次。由於HEPZATO KIT 是一種針對肝臟的介入放射學手術，而不是一種輸注藥物，因此我們重點關注目前提到的醫療中心，這些中心目前為轉移性葡萄膜黑色素瘤患者提供針對肝臟的治療，並且目前正在治療大量肝病患者。定向治療。值得注意的中心包括由葡萄膜黑色素瘤腫瘤學家思想領袖 Marlana Orlof 領導的托馬斯傑斐遜大學；以及介入放射科醫師 David Eschelman，肝臟導向治療領域的領導者。迄今為止，托馬斯·傑斐遜治療的轉移性葡萄膜黑色素瘤患者數量是全國最多的。

Other noteworthy centers include UCLA with uveal melanoma thought leader, medical oncologist, Bartosz Chmielowski; and interventional radiologists, Sid Padia. Mayo Clinic with medical oncologists, Roxana Dronca; and Yiyi Yan interventional oncologists, Charles Ritchie and [Botox]. Moffitt Cancer Center with the FOCUS trial principal, John Jaeger; and Stanford University with medical oncologists Sunil Reddy and interventional radiologist Gloria Huang. Since approval, Kevin Muir, Delcath's General Manager, Interventional Oncology has been busy building the commercial organization. Kevin has made a point of bringing out team members that have deep experience in launching complex therapies, require multiple stakeholders in the hospital setting.

其他值得注意的中心包括加州大學洛杉磯分校葡萄膜黑色素瘤思想領導者、醫學腫瘤學家 Bartosz Chmielowski；和介入放射科醫生 Sid Padia。梅奧診所 (Mayo Clinic) 與腫瘤內科醫生 Roxana Dronca 合作；以及Yiyi Yan 介入性腫瘤學家 Charles Ritchie 和 [Botox]。莫菲特癌症中心與 FOCUS 試驗負責人 John Jaeger；史丹佛大學的腫瘤內科醫生 Sunil Reddy 和介入放射科醫生 Gloria Huang。自從獲得批准以來，Delcath 介入腫瘤學總經理 Kevin Muir 一直忙於建立商業組織。凱文（Kevin）強調要培養在推出複雜療法方面擁有豐富經驗的團隊成員，這需要醫院環境中的多個利害關係人。

For example, our new Director of Sales, Zac MacLean, comes from Boston Scientific and has over 20 years experience leading teams and bringing new liver-based interventional procedures to market. Under Zac's guidance, we have divided the US into four regions, each of which will be served by a commercial team comprised of a liver-directed therapy representative and two oncology managers. The liver-directed therapy representative will manage the hospital approval process and ensure that the HEPZATO KIT procedure team is trained and supported while performing the procedure. The oncology managers will engage community-based medical oncologists outside of our treating centers, with the goal of building referral networks to the oncologists within the treating centers.

例如，我們的新銷售總監 Zac MacLean 來自 Boston Scientific，擁有 20 多年領導團隊以及將新的肝臟介入手術推向市場的經驗。在札克的指導下，我們將美國分為四個區域，每個區域將由肝臟導向治療代表和兩名腫瘤學經理組成的商業團隊提供服務。肝臟導向治療代表將管理醫院審批流程，並確保 HEPZATO KIT 手術團隊在執行手術時得到培訓和支援。腫瘤經理將聘請我們治療中心以外的社區腫瘤科醫生，目標是建立治療中心內腫瘤科醫生的轉診網絡。

In addition, each team will be supported by a clinical specialist, who will support the treatment teams in preparation for and during the treatment, with the goal of ensuring patient safety and improving patient outcomes. To ease patient access, Kevin's team has been working with market access consultants to submit the required applications to obtain the C code, J code, and Empath from CMS. Given the nature of HEPZATO KIT, we anticipate all codes and add-on payments to be granted. We are in the final stages of designing a patient access program called HEPZATO KIT Access, designed to assist patients and hospitals in numerous aspects of treatment planning, including prior authorization.

此外，每個團隊都將得到一名臨床專家的支持，他們將在治療準備和治療期間為治療團隊提供支持，以確保患者安全並改善患者治療結果。為了方便患者訪問，Kevin 的團隊一直在與市場准入顧問合作，提交所需的申請，以從 CMS 獲取 C 代碼、J 代碼和 Empath。鑑於 HEPZATO KIT 的性質，我們預計所有代碼和附加付款都會被授予。我們正處於設計名為 HEPZATO KIT Access 的患者訪問計劃的最後階段，該計劃旨在在治療計劃的多個方面（包括事先授權）為患者和醫院提供幫助。

We are working with a well established hub service with significant experience in both the ultra orphan diseases and oncology to design and manage this program. We continue to support both internal and external efforts to add to a growing body of evidence that the PHP procedure, whether utilizing melphalan delivered by Delcath CHEMOSAT or the HEPZATO KIT, is an important treatment option for patients with liver dominant uveal melanoma. We recently announced the publication of results from a retrospective comparative study of CHEMOSAT and selective internal radiation or SIRT, published in the Journal of Cancers.

我們正在與一個在超級孤兒疾病和腫瘤學方面擁有豐富經驗的完善的中心服務機構合作來設計和管理該計畫。我們繼續支持內部和外部的努力，以增加越來越多的證據，證明 PHP 手術，無論是使用 Delcath CHEMOSAT 還是 HEPZATO KIT 提供的美法崙，都是肝優勢葡萄膜黑色素瘤患者的重要治療選擇。我們最近宣佈在《癌症雜誌》上發表 CHEMOSAT 和選擇性內放射或 SIRT 的回顧性比較研究結果。

The independent investigator study from the University Hospital of Tübingen, Germany compared two liver-directed therapies: multiple cycles of SIRT versus two treatments of percutaneous hepatic perfusion of CHEMOSAT in patients with liver-dominant metastatic uveal melanoma. Median overall survival was 301 days for the 34 patients treated with SIRT and 516 days for the 28 patients treated with CHEMOSAT. An adjusted Cox regression model, there was a significant difference between SIRT and CHEMOSAT, with a hazard ratio of 0.32, an associated 95% competence interval of 0.14 to 2.73, and a p-value of 0.006. The overall survival results clearly demonstrate the positive impact of treating liver metastases on patient outcomes of CHEMOSAT.

德國蒂賓根大學醫院的獨立調查研究比較了兩種肝臟定向療法：對肝臟為主的轉移性葡萄膜黑色素瘤患者進行多周期 SIRT 與兩種經皮肝灌注 CHEMOSAT 治療。接受 SIRT 治療的 34 名患者的中位總存活期為 301 天，接受 CHEMOSAT 治療的 28 名患者的中位總存活期為 516 天。調整後的 Cox 迴歸模型顯示，SIRT 與 CHEMOSAT 之間有顯著差異，風險比為 0.32，相關的 95% 能力區間為 0.14 至 2.73，p 值為 0.006。總生存率結果清楚地證明了 CHEMOSAT 治療肝轉移對患者預後的正面影響。

As a reminder, there is an ongoing investigator-initiated randomized Phase 2 trial in Europe, the [Schupan] trial, evaluating the effect of adding immunotherapeutic to CHEMOSAT liver-directed therapy. The trial has enrolled 55 of the planned 76 patients and the investigators expect the trial to be fully enrolled mid-2024. The primary objective of the trial is to determine the efficacy of combination treatment of immunotherapy with ipilimumab and nivolumab with CHEMOSAT treatment versus CHEMOSAT, defined by progression-free survival at one-year. Secondary objectives include overall survival and overall response rate. An interim futility analysis conducted in September resulted in an Independent Data Monitoring Committee recommended the continuation of the study without modification.

提醒一下，歐洲正在進行一項由研究者發起的隨機 2 期試驗，即 [Schupan] 試驗，評估在 CHEMOSAT 肝臟定向治療中添加免疫療法的效果。該試驗已入組計畫中的 76 名患者中的 55 名，研究人員預計該試驗將在 2024 年中期全部入組。本試驗的主要目的是確定伊匹單抗和納武單抗合併免疫療法與 CHEMOSAT 治療對比 CHEMOSAT 的療效，定義為一年無惡化存活期。次要目標包括整體存活率和整體緩解率。 9 月進行的臨時無效性分析得出的結果是，獨立數據監測委員會建議繼續進行該研究，無需修改。

As mentioned earlier, we now expect to start our commercial sales in January 2024. We have been utilized the time between approval and launch to increase the number of trained treating centers and initiating the formulary approval process in numerous institutions. The feedback and progress to date gives us confidence that HEPZATO KIT will become the standard of liver-directed therapy care for metastatic uveal melanoma patients quickly after launch. I will now hand the call over to Sandra to share some details on our financial position. Sandra?

如前所述，我們現在預計於 2024 年 1 月開始商業銷售。我們利用批准和啟動之間的時間來增加經過培訓的治療中心的數量，並在眾多機構啟動處方審批流程。迄今為止的回饋和進展讓我們相信，HEPZATO KIT 在推出後很快就會成為轉移性葡萄膜黑色素瘤患者肝臟導向治療的標準。我現在將把電話轉給桑德拉，分享我們財務狀況的一些細節。桑德拉？

Thank you, Gerard. We ended Q3 with $40.5 million in cash. Cash used in operations was approximately $9.2 million in the third quarter and $23.1 million for the first nine months of the year. The increase in cash is due to the funding received as part of the Tranche A warrant exercise. Specifically, the Tranche A warrants were exercised for $35 million for the equivalent of $7.5 million in common stock.

謝謝你，傑拉德。第三季末，我們擁有 4,050 萬美元現金。第三季營運中使用的現金約為 920 萬美元，今年前 9 個月營運中使用的現金約為 2,310 萬美元。現金增加是由於 A 批認股權證行使中收到的資金所致。具體而言，A 部分認股權證以 3,500 萬美元的價格行使，相當於 750 萬美元的普通股。

The $35 million should be sufficient to fund the company until another 4.1 million shares of common stock equivalents are issuable at a strike price of $6 as part of the Tranche B warrants, without having to issue additional equity capital. The Tranche B warrants would result in $25 million of gross proceeds, upon the company achieving $10 million in quarterly revenue. Current shares outstanding are 22.1 million and 40.5 million, on a fully diluted basis. Revenue from our sales of CHEMOSAT was $0.4 million for the three months ended September 30, 2023, compared to $0.9 million for the three months ended September 30, 2022.

3500 萬美元應該足以為公司提供資金，直到作為 B 部分認股權證的一部分，以 6 美元的執行價格發行另外 410 萬股普通股等價物，而無需發行額外的股本。當公司季度營收達到 1,000 萬美元時，B 部分認股權證將帶來 2,500 萬美元的總收益。目前已發行的股份在完全稀釋的基礎上分別為 2,210 萬股和 4,050 萬股。截至2023年9月30日止三個月，我們的CHEMOSAT銷售收入為40萬美元，而截至2022年9月30日止三個月為90萬美元。

For the three months ended September 30 this year, R&D expenses were $4.7 million compared to $4.1 million for the three months ended September 30, 2022. The increase is due to activities related to the FDA inspection and other requests in advance of the approval of HEPZATO. For the three months ended September 30, 2023, compared to the same period in 2022, selling, general, and administrative expenses have increased from $4.8 million to $6.2 million, due to activities to prepare for commercial launch. That concludes our earnings and business update and I'd ask the operator to open the line for Q&A. Can you please check for questions?

截至今年9 月30 日的三個月，研發費用為470 萬美元，而截至2022 年9 月30 日的三個月為410 萬美元。增加的原因是與FDA 檢查相關的活動以及HEPZATO 批准之前的其他要求。截至 2023 年 9 月 30 日的三個月，與 2022 年同期相比，由於準備商業發布的活動，銷售、一般和管理費用從 480 萬美元增加到 620 萬美元。我們的收益和業務更新到此結束，我會要求接線員開通問答線路。您能檢查一下有問題嗎？

(Operator Instructions) Bill Maughan, Canaccord Genuity.

（操作員說明）Bill Maughan，Canaccord Genuity。

Hi, good afternoon and thank you. So I have two questions. So you talk about getting sites up and running and the last hurdles to go through being proctor availability and sites value analysis committee approvals. On the sites value analysis committee approvals, how active is Delcath in that process? Or is that generally an internal hospital process and how certain is the outcome of those processes? In other words, is it a check-the-box operation or is there any uncertainty in that approval? Second question, is how do you see --HEPZATO being used interact? Are those patients simply too far along to be an addressable market? Thanks.

你好，下午好，謝謝。所以我有兩個問題。因此，您談到了網站的啟動和運行，以及要克服的最後障礙是監考人員的可用性和網站價值分析委員會的批准。在網站價值分析委員會的批准方面，Delcath 在過程中的積極程度如何？或者這通常是醫院內部流程，這些流程的結果有多大確定性？換句話說，這是一個勾選操作還是批准過程中存在任何不確定性？第二個問題，您如何看待 --HEPZATO 的使用互動？這些患者是否已經發展得太遠，無法成為潛在市場？謝謝。

All right, yes. Let me start with the first question, Bill, good to hear from you. And I think, Kevin, you can probably add some color to this, but I think I wouldn't go as far, as I say, check the box. But I would also say and add some color to this that we have a lot of sites. There's no place that we're moving forward in aggressively where we're not confident of support. But, Kevin can give some color there. And we certainly support the sites to some extent. But I think the days that the company going and presenting are long gone. But you do have to support them to some to some extent. But Kevin, can you add some color to?

好吧，是的。讓我從第一個問題開始，比爾，很高興收到你的來信。我想，凱文，你也許可以為此添加一些色彩，但我想我不會走得那麼遠，正如我所說的，勾選複選框。但我還要說的是，並為此添加一些色彩，我們有很多網站。我們積極推進的所有領域都將得到我們的支持。但是，凱文可以在那裡提供一些顏色。我們當然在某種程度上支持這些網站。但我認為公司去展示的日子早已一去不復返了。但你確實必須在某種程度上支持他們。但是凱文，你能添加一些顏色嗎？

Yes, Gerard. Thank you. It's far from check-the-box. It's a formal process within each facility. And they're basically looking for, if we code this procedure, will we get paid, will we get reimbursed. And so we are asked to provide a limited amount of information and that hospital makes its decision on itself.

是的，傑拉德。謝謝。這離勾選框還很遠。這是每個設施內的正式流程。他們基本上是在尋找，如果我們寫這個程序，我們會得到報酬，我們會得到報銷嗎？因此，我們被要求提供有限的信息，醫院自行做出決定。

We feel confident with our hub services, as Gerard mentioned earlier in the call, and they're assisting with the coding forecast for the facilities. And then it's up to them to see if that's beneficial to them. And the feedback that we've had to this point in time has been very good. So we're confident that out of the 11 sites that George mentioned, we'll have five of them that will perform procedures by the end of January.

正如傑拉德之前在電話中提到的那樣，我們對我們的中心服務充滿信心，他們正在協助對設施進行編碼預測。然後由他們來看看這是否對他們有利。到目前為止，我們收到的回饋非常好。因此，我們有信心在 George 提到的 11 個站點中，我們將有 5 個站點將在 1 月底之前執行程序。

And Kevin, I think it's fair to say that -- there have been a number of these meetings already, and it's usually not just one meeting. But a number of meetings have started. We've yet to have any gist this isn't going to happen type reactions, is that correct?

凱文，我認為可以公平地說，已經召開過很多次這樣的會議，而且通常不僅僅是一次會議。但一些會議已經開始。我們還沒有任何證據表明這不會發生類型反應，對嗎？

Yeah, it's entirely correct. We've been overwhelmed by the response that we've had and the two-way communications that we've had with each hospital to this point of time. As George mentioned, we've had several of these calls or presentations that we've made to the hospitals. And we anticipate most, if not all of these, coming back with the value analysis committee in our favor.

是的，這是完全正確的。到目前為止，我們對每家醫院的反應以及我們與每家醫院進行的雙向溝通感到不知所措。正如喬治所提到的，我們已經向醫院打過幾次這樣的電話或演示。我們預期大多數（如果不是全部）的價值分析委員會都會對我們有利。

Now, Bill, in terms of your second question, our patients who are post-event of us, will they be too far gone, too far progressed. And I think the answer is some maybe, some may not be. I think if we take a step back, the first question really is, should you use liver-directed first. There are certainly some oncologists out there who believe that, in many cases, liver-directed first makes sense. There are others that want to go to systemic first.

現在，比爾，就你的第二個問題而言，我們事件後的患者，他們是否會走得太遠，進步得太遠。我認為答案是有些可能，有些可能不是。我認為如果我們退一步，第一個問題確實是，您是否應該先使用肝臟導向的藥物。當然，有些腫瘤學家認為，在許多情況下，首先以肝臟為導向是有意義的。還有其他人想先進入系統。

So it's not going to be everyone automatically going competitive first. I think one of the points we're going to make to oncologists is that you can tell after two treatments from us, whether or not you're getting a benefit. With [tubekistat], they recommend treating through progression versus suite of progression with immunooncology agents. So you run the risk of going too long with heavy before you really know whether it's working or not. So it may make sense to start with us from that rationale.

因此，並不是每個人都會自動先參與競爭。我認為我們要向腫瘤學家提出的一點是，您可以在接受我們的兩次治療後判斷您是否受益。對於[tubekistat]，他們建議透過進展進行治療，而不是使用免疫腫瘤藥物進行一系列進展治療。因此，在你真正知道它是否有效之前，你可能會冒著長時間使用重物的風險。因此，從這個基本原理開始我們可能是有意義的。

The third thing I'll say is we have seen patients post heavy. So we've seen patients that are applicable for TV coming with us. First, are you seeing patients post heavy. So clearly, it's going to be a mix, but we think we have a sound argument because the liver is usually the life-limiting organ site of metastases and you can get a quicker read on whether you're getting efficacy when go with us first. We think we have a good argument to go and that's first. But if not, I think we'll still get a fair number of those type B patients that unfortunately eventually progress.

我要說的第三件事是我們看到患者體重過重。所以我們看到了適合電視的病人和我們一起來的。首先，您是否看到患者體重過重。很明顯，這將是一個混合體，但我們認為我們有一個合理的論據，因為肝臟通常是轉移的限制生命的器官部位，當您首先與我們一起時，您可以更快地了解您是否獲得療效。我們認為我們有一個很好的論點要進行，這是第一位的。但如果沒有，我認為我們仍然會得到相當數量的 B 型患者，不幸的是他們最終會取得進展。

Got it. Thank you very much.

知道了。非常感謝。

Scott Henry, ROTH Capital.

史考特·亨利，羅斯資本。

Thank you and good afternoon. Just had a couple of questions: first, as far as -- I'm just thinking about the launch metrics you've laid out, Gerard. When we think about one per month moving to two per month, do you think about that as an average? Or do you think of that as a high volume location? Just trying to get a sense because I know, obviously, some people will do more, some will do less. How you are trying to put that one to two and reference?

謝謝你，下午好。只是有幾個問題：首先，傑拉德，我只是在考慮您列出的啟動指標。當我們考慮每月一次變為每月兩次時，您是否認為這是平均值？或者您認為那是一個高流量位置？只是想了解一下，因為我知道，顯然，有些人會做得更多，有些人會做得更少。您如何嘗試將這一點一比二並作為參考？

Yeah, here's what we have: before we really get out there and get moving up kind of averaging, but maybe down, who knows? I do know, I'm confident there'll be some sites that are doing one a week, but I think there are others, as they get started and we're building the referral networks, they might be doing one every two months. Eventually, my hope is that sites do at least one a week out sometime over the horizon and that's where we need to do to get to peak share. But it's definitely an average and it's really thinking there's one or two sites doing most of those and the new ones that have recently come onboard, they're building the referral networks.

是的，這就是我們所擁有的：在我們真正走出去並提高平均水平之前，但也許會下降，誰知道呢？我確實知道，我相信會有一些網站每週做一次，但我認為還有其他網站，當他們開始並且我們正在建立推薦網絡時，他們可能每兩個月做一次。最終，我希望網站在不久的將來至少每週推出一次，這就是我們需要做的以達到峰值份額。但這絕對是一個平均值，而且確實認為有一兩個網站完成了大部分工作，而最近加入的新網站正在建立推薦網絡。

Okay, great. And when we think about cycles per patient, how would you think about the average cycle, number of cycles that a patient would have? And how much time between cycles should we expect in utilization?

好的，太好了。當我們考慮每位患者的週期時，您會如何考慮患者的平均週期、週期數？我們在利用率方面應該期望週期之間有多少時間？

What we saw in the FOCUS trial, I think, as we know was 4.1, so for our own modeling purposes, assuming 4. In the FOCUS trial, we allowed patients to go up to eight weeks between cycles, six with the recommended. I think what we're seeing, what we've seen in other settings here is that some docs, more in compassionate use setting us on earlier in the US, some docs choose to do too quickly together. Let's say six to eight weeks apart and then we're watchful waiting. Others followed the protocol perfectly.

我認為，正如我們所知，我們在FOCUS 試驗中看到的是4.1，因此出於我們自己的建模目的，假設為4。在FOCUS 試驗中，我們允許患者在周期之間進行長達八週的週期，其中建議週期為6 週。我認為我們所看到的，我們在其他環境中看到的是，一些文檔，更多的是在美國早些時候為我們提供了富有同情心的使用，一些文檔選擇太快地一起做。假設相隔六到八週，然後我們就會警戒地等待。其他人則完美地遵循了該協議。

So I think my guess is we're going to have a subset that do two weeks apart and then wait, others are going to go straight through. One thing I am certain of is patients that we've lost in the trial that withdrew because their blood counts had not risen to the level where it is appropriate to re-treat them, we won't lose those likely in the commercial setting because the doctor just wait a few extra weeks. So on average, I think it be --go ahead.

所以我想我的猜測是我們將有一個子集間隔兩週進行，然後等待，其他人將直接完成。我確信的一件事是，我們在試驗中失去了一些患者，因為他們的血球計數沒有上升到適合重新治療的水平，我們不會失去那些可能在商業環境中的患者，因為他們醫生只需再等幾週。所以平均而言，我認為是——繼續吧。

So when we think about cycles per quarter as we model out expectations for the launch, and obviously everyone doesn't come in the first day of the quarter, it sounds like we should we should think about it as one to two cycles per quarter, depending when (multiple speakers).

因此，當我們在對發布的預期進行建模時考慮每季度的周期時，顯然每個人都不會在該季度的第一天到來，聽起來我們應該將其視為每季一到兩個週期，取決於時間（多個發言者）。

One to two, yeah. One on an average starting out early in the first quarter, one treatment a month per site and then two. And then when I say treatment, I mean a cycle or a treatment. It could be -- we're not really counting patients right now because we're just scratching the surface at these levels in terms of the TAM. At some point, we'll have to start talking about number of patients on therapy. But right now, we're just focused on treatments per cycles.

一比二，是的。平均在第一季初期開始一次，每個地點每月一次治療，然後兩次。當我說治療時，我指的是一個週期或一次治療。可能是——我們現在並沒有真正計算患者數量，因為我們只是在 TAM 方面觸及了這些水平的表面。在某些時候，我們將不得不開始討論接受治療的患者數量。但現在，我們只關注每個週期的治療。

Okay. And Gerard, -- for the typical hospital, maybe if you could just walk through how that hospital gets paid with this product? What is the procedure and how we should think about that?

好的。傑拉德，對於典型的醫院，也許您可以簡單介紹一下該醫院如何透過該產品獲得報酬？程序是什麼？我們該如何考慮？

Yeah. So for the typical hospital, there will be three components of payments, right? We're going to talk about outpatient because the majority of these patients will be outpatient. They're going to put in a set of CPT codes for a facility fee. They're going to put in a set of CPT codes for the procedure, for the doctor's time. Now, most of the doctors are on salaries, so it's not a direct incentive to them, but they do care.

是的。那麼對於典型的醫院來說，付款將由三個部分組成，對吧？我們將討論門診患者，因為這些患者中的大多數將是門診患者。他們將輸入一組 CPT 代碼來支付設施費。他們將在程式中輸入一組 CPT 代碼，以供醫生使用。現在，大多數醫生都是拿薪水的，所以這對他們來說不是直接的激勵，但他們確實關心。

The third reimbursement component will be putting in for reimbursement for the drug itself, HEPZATO KIT. That will initially be with a C code and that eventually we will get a J code. But that's a pass through payments so the hospital would get paid, whatever we charge them plus 6%. Let me just pause there and see if there's any more detail or any particular particular part of that process that you'd like to hear about?

第三個報銷部分將用於報銷藥物本身 HEPZATO KIT。最初將使用 C 代碼，最終我們將獲得 J 代碼。但這是一種轉手付款，因此無論我們向他們收取什麼費用，醫院都會得到報酬，再加上 6%。讓我暫停一下，看看您是否想了解該過程的更多細節或任何特定部分？

No, I think that's a good -- so these three codes that all come into place, are all of them necessarily to start the process or is there a sequence that hospitals will want to as they utilize this?

不，我認為這是一個很好的 - 那麼這三個代碼都已到位，它們是否都必須啟動該過程，或者醫院在使用它時是否希望有一個順序？

Kevin, why don't you explain the availability of having a CPT codes work in terms of being a portfolio of codes they're going to use? And then what they'll do initially and then when the C code comes on more than a J code?

Kevin，為什麼不解釋一下 CPT 程式碼作為他們將要使用的程式碼組合的可用性？那麼當 C 代碼出現多於 J 代碼時，他們最初會做什麼？

Yeah, so thanks, George. So CPT codes are nothing more than the codes that describe what the physicians are doing during the procedure. So when they go through the step, -- when they go through the procedure, they will record what they do, the CPT codes will match what they do, they're presented to CMS, and the payment comes back. So there's going to be two payments: one for the hospital, one for the physicians.

是的，謝謝，喬治。因此，CPT 代碼只不過是描述醫生在手術過程中所做操作的代碼。因此，當他們完成該步驟時，--當他們完成該程序時，他們將記錄他們所做的事情，CPT 代碼將與他們所做的事情相匹配，然後將其提交給 CMS，然後付款返還。因此，將有兩筆付款：一筆支付給醫院，一筆支付給醫生。

We've gone through a number of coding exercises to ensure both ourselves and our hospital partners that this will be -- there are codes in place and if they code them correctly or they do the procedure, then the hospital will be reimbursed fully for what they are doing. Physicians, the same thing: their codes will pay them adequately for their time. So those are the two main concerns when you really come down to it. This is a lot of work done from an earlier question on the value analysis committe: make sure the CPT codes are there for the hospital and physician. And then a final part of that is the product.

我們已經進行了多次編碼練習，以確保我們自己和我們的醫院合作夥伴都做到這一點——有適當的代碼，如果他們編碼正確或執行了程序，那麼醫院將獲得全額補償他們在。醫生也是如此：他們的代碼將為他們的時間提供足夠的報酬。因此，當您真正認真考慮時，這是兩個主要問題。這是價值分析委員會之前提出的問題中所做的大量工作：確保醫院和醫生都有 CPT 代碼。最後一部分是產品。

And we should anticipate hearing very soon back from CMS on our C-code, -- it's actually called TPT kit, transitional pass-through applications, which resolved through the C-code. We anticipate and hearing on that shortly. Those usually go into effect on January 1t, but sometimes they drag into January. So that should, as Gerard mentioned, be a pass-through payment for the hospital and they get a 6% administration fee on top of that. So again, from the customers that are from the hospital that we talk to this point in time, there seems to be more than adequate reimbursement for them to move forward.

我們應該很快就會收到 CMS 關於我們的 C 代碼的回复，它實際上稱為 TPT 套件，過渡傳遞應用程序，透過 C 代碼解決。我們預計很快就會聽到這一消息。這些通常在 1 月 1 日生效，但有時會拖到 1 月。因此，正如傑拉德所提到的，這應該是醫院的轉手付款，除此之外他們還可以獲得 6% 的管理費。再說一次，從我們目前交談的醫院的客戶來看，似乎有足夠的報銷讓他們繼續前進。

Okay. Great. That's helpful, Gerard, that should do it for me. Thank you.

好的。偉大的。這很有幫助，傑拉德，應該對我有用。謝謝。

Thanks so much, Scott.

非常感謝，斯科特。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hey, good afternoon. This is Sam Eiber on for Marie. Thanks for taking the questions and congrats on the progress getting through some of those treatment sites. Maybe I can use my first question here on the work with the CMOs. I think I caught your comments earlier on the call that it's taking a bit longer than expected. Just wanted to get any additional color on maybe some of the bottlenecks or work that's going on behind the scenes there. Thanks.

嘿，下午好。我是薩姆·艾伯（Sam Eiber）為瑪麗代言。感謝您提出問題，並祝賀某些治療地點的進展。也許我可以用我的第一個問題來談談與 CMO 的合作。我想我早些時候在電話會議上聽到了您的評論，花費的時間比預期要長一些。只是想了解一些可能存在的瓶頸或幕後正在進行的工作。謝謝。

Sure. So we've known for quite a while that we'd like to work more directly with a CMO for melphalan. Given that series of acquisitions, based on who we initially signed up with melphalan, I won't go through all the details. We ended up in a situation where [my land] holds the ANDA and they used the CMO pharma in Italy. There are pharma uses a set of CMOs or contract labellers to make the various labels and such.

當然。因此，我們很早就知道我們希望與馬法蘭的 CMO 更直接合作。鑑於這一系列收購，根據我們最初與馬法蘭簽約的人，我不會詳細介紹所有細節。我們最終遇到了這樣的情況：[我的土地]持有 ANDA，而他們在義大利使用了 CMO 製藥公司。有些製藥公司使用一組 CMO 或合約貼標商來製作各種標籤等。

We have tried prior to approval and post-approval to take some of that work on ourselves, saying ship us naked vials, we'll label it, we'll make the labels and shipping that to Italy, anything we can to accelerate this. And unfortunately, since we're a very small player for this generic product in these nested manufacturers, we really are having difficulty moving getting them to move off of what they say is basically here's your contracted lead times. Now, there really was no way in our position to write a large check or even guess what the final label would be to get way ahead of us.

我們已經嘗試在批准之前和批准後自行承擔一些工作，說向我們運送裸露的小瓶，我們將對其貼上標籤，我們將製作標籤並將其運送到意大利，盡我們所能來加速這一過程。不幸的是，由於我們在這些嵌套製造商中是這種通用產品的很小的參與者，因此我們確實很難讓他們擺脫他們所說的基本上是您的合約交貨時間。現在，我們確實沒有辦法寫一張大支票，甚至無法猜測最終的標籤是什麼，從而領先於我們。

This is an unusual situation, again, when we're using a generic product and we're getting them to carve out a small run for us. And that's really what the bottom-line is. You know, could it have been a little smoother? Perhaps, but at the end of the day, we've got to work with what I'm calling this message CMOs. This would be a problem longer-term. We've already got an order in for a second full batch, which will be delivered probably shortly after the first batch. And so that will be in a well supplied going forward. We wouldn't have these bottlenecks anymore.

這又是一種不尋常的情況，當我們使用通用產品並讓他們為我們開闢一個小市場時。這確實是底線。你知道，事情可以更順利一點嗎？也許吧，但最終，我們必須與我所說的資訊行銷長合作。從長遠來看，這將是一個問題。我們已經收到了第二批完整訂單的訂單，可能會在第一批之後不久交付。因此，未來的供應將會充足。我們不會再有這些瓶頸了。

But again, it's a situation where we never really in a position to fund our own ANDA for this type of thing. So we just have to live with the situation. And as we go forward, we're going to focus a lot on making sure the supply chain is robust as possible and we don't have any -- we're never had a stock-out situation or a slowdown situation.

但同樣，在這種情況下，我們從來沒有真正能夠為此類事情資助我們自己的 ANDA。所以我們只能忍受這種情況。隨著我們的前進，我們將重點關注確保供應鏈盡可能穩健，我們從未出現過缺貨或放緩的情況。

Okay. Yes, that all makes sense. I appreciate the added color there. And maybe I could use my follow-up here on some of the VAC approval process questions. How long did these usually take? I mean, we hear for other products that could take 6 to 12 months. I assume that is probably a bit quicker here, recognize it's not just a check-the-box item, but just wondering your thoughts on how long those back approvals you expect to take?

好的。是的，這一切都有道理。我很欣賞那裡添加的顏色。也許我可以在這裡對一些 VAC 審批流程問題進行後續跟進。這些通常需要多長時間？我的意思是，我們聽說其他產品可能需要 6 到 12 個月的時間。我認為這可能會更快一些，認識到這不僅僅是一個複選框項目，只是想知道您對預計需要多長時間的回批准的想法？

Yes, I think what's unique about this is, well, this is not another antibiotic for a hospital-acquired infection or another step. This is a product where there is nothing else like it for this patient set. And our interventional radiologists and medical oncologists are very happy to champion this and push this forward outside of the regularly scheduled meetings. Now, what I'm doing here is repeating what Kevin has told me. Kevin, is there anything I left out in terms of the product (multiple speakers).

是的，我認為它的獨特之處在於，這不是另一種治療醫院獲得性感染的抗生素或另一個步驟。對於該患者套件來說，這是一款獨一無二的產品。我們的介入放射科醫生和腫瘤內科醫生非常樂意支持這項舉措，並在定期會議之外推動這項舉措的發展。現在，我在這裡所做的就是重複凱文告訴我的話。凱文，在產品方面我有遺漏什麼嗎（多個揚聲器）。

No, but to add a little color to the question, you're right: I mean, throughout my entire career, I've budgeted nine months for one of these value analysis committees. And again, it's been what has been so encouraging about this is that we have ultra rare disease, lack of a standard of care for some of these patients, and we're also at the right hospitals. And so they recognize the need for the product that we're bringing and we're moved up of that nine months and we're probably closer to three months. And even in some scenarios, maybe shorter than that. So it's been very encouraging for the response that we've received from these committees.

不，但為了給這個問題增添一點色彩，你是對的：我的意思是，在我的整個職業生涯中，我為這些價值分析委員會之一制定了九個月的預算。再說一次，令人鼓舞的是，我們患有極其罕見的疾病，其中一些患者缺乏標準的護理，而且我們也在合適的醫院。因此，他們認識到對我們帶來的產品的需求，我們將這九個月提前了，可能接近三個月了。即使在某些情況下，也可能比這更短。因此，我們從這些委員會收到的回應非常令人鼓舞。

Okay, really helpful. And maybe just a clarification question, how many of the proctor sites do you have in the US that could essentially do the proctor cases or that you expect to have?

好的，真的很有幫助。也許只是一個澄清問題，您在美國有多少個監考網站可以基本上完​​成監考案件或您期望擁有多少個監考網站？

Kevin?

凱文？

Yeah, looking at my list right now. We have the three CAP sites that are ready to go. The rest of the FOCUS trial sites have abbreviated training requirements, so that would be another one, two, three, four. So we'll have seven.

是的，現在正在看我的清單。我們已經準備好三個 CAP 站點。其餘的 FOCUS 試驗點都有簡化的訓練要求，因此又是一、二、三、四。所以我們會有七個。

But Kevin, in terms of proctor teams ready to go, it's Moffitt, right?

但是凱文，就準備出發的監考團隊而言，是莫菲特，對吧？

Oh, proctor team? Yeah, yeah, I'm sorry, I misunderstood the question.

哦，監考團隊？是的，是的，對不起，我誤解了這個問題。

Yes, and that's one of the reasons it's going to be a bit slow, but we'll have another team. You have two or three teams up and going within a few months and we have a number of teams in Europe who are more than happy to fly over and proctor. So we're probably going to end up relying on some European teams as well.

是的，這就是速度會有點慢的原因之一，但我們會有另一個團隊。你有兩到三個團隊在幾個月內就開始運作，我們在歐洲有很多團隊非常樂意飛過來監考。所以我們最終可能也會依賴一些歐洲球隊。

Got it. Okay. Thanks for taking the questions.

知道了。好的。感謝您提出問題。

Yeah.

是的。

Yale Jen, Laidlaw & Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

Good afternoon and thanks for taking the questions and congrats on the progress.

下午好，感謝您提出問題並祝賀取得的進展。

Thank you, Yale.

謝謝你，耶魯。

Good evening. A couple of quick ones: first one is, in terms of your inventory preparation for the launch -- by end of this year or beginning of next year, what do you think your inventory level might be and how would that be? Are adequate to supply the potential anticipate to use over the next subsequent quarters?

晚安.幾個簡單的問題：第一個是，就您為發布所做的庫存準備而言，到今年年底或明年初，您認為您的庫存水平可能會是多少？會是怎樣？是否足以滿足未來幾季預期使用的潛力？

Okay. I guess the first question, the inventory level and the answer to that is we're trying to maintain at least a year's worth of inventory. I think once -- so that will be a rolling demand forecast looking forward, I think once we get past the $10 million revenue milestone, that will bring more cash to the balance sheet, we'll be just short of being breakeven on an EBITDA basis. I think we'll probably increase safety stock beyond the year on certain components, just to be careful because it's not always easy to switch up components as suppliers change. So that's answer to your first question. What was the second now?

好的。我想第一個問題是庫存水平，答案是我們正在努力維持至少一年的庫存。我認為一旦——這將是一個滾動的需求預測，我認為一旦我們超過了 1000 萬美元的收入里程碑，這將為資產負債表帶來更多現金，我們將在 EBITDA 上實現盈虧平衡基礎。我認為我們可能會增加某些組件的安全庫存，只是要小心，因為隨著供應商的變化，更換組件並不總是那麼容易。這就是你第一個問題的答案。現在第二個是什麼？

When you start to launch the product are you have adequate or how do you speed that the preparation at the time?

當你開始推出產品時，你的準備工作是否充足，或者你如何加快當時的準備工作？

So do we have adequate? I think we will probably be, based on orders coming in this this year. And once the melphalan shows up, we'll have -- every component we will have at least a year's worth of stock.

那我們有足夠的資源嗎？我認為，根據今年收到的訂單，我們可能會這樣做。一旦馬法蘭出現，我們將擁有—每個組件，我們將擁有至少一年的庫存。

Okay, great, that's helpful. And my second question here is that, given you indicated there's roughly 10 sites ultimately for -- in the queue for the -- first-half of next year, what is your estimate on that the total potential patient size or procedure number of the orders 10 combined.

好的，太好了，很有幫助。我的第二個問題是，鑑於您表示最終大約有 10 個站點在明年上半年的隊列中，您對訂單的潛在患者總數或手術數量的估計是多少合計10個。

So are you asking what I think the volume will be for the full-year?

那麼您是在問我認為全年的銷售量是多少嗎？

For the full-year from the 10, I guess, hospitals exactly.

我猜是 10 家醫院的全年數據。

Yeah, let me stick with what I've said before and that is: I think you can probably do the math and that is with a little bit of range, which was I'm trying to ensure here is five. By the end of the quarter, we'll definitely have five sites up and running. And I think at ending the quarter, we'll be doing at least one month. Middle of the year, at least 10 sites up and running. End of the year, at least 15 sites up and running. And they should end the year, doing at least two a month exiting the year.

是的，讓我堅持我之前所說的，那就是：我認為你可能可以做數學，這是有一點範圍的，我試著確保這裡是五個。到本季末，我們肯定會建立並運行五個站點。我認為在本季結束時，我們將至少進行一個月的工作。年中時，至少有 10 個站點啟動並運行。到今年年底，至少有 15 個站點投入運作。他們應該在今年結束時，每月至少做兩次。

You can get a fairly wide range, plus or minus 30% in terms of volume, depending on when you assume they get there within the quarter. In terms of how many patients that represents, whatever number you have divided by four.

你可以獲得一個相當寬的範圍，就數量而言，可以有正負 30%，這取決於你假設他們在本季度內何時達到該水平。就代表的患者數量而言，無論您將數字除以四。

Okay, sounds good. And maybe the last question here is that, is there any patient you anticipate at all to be in the procedures when you launch the product? In other words, they become paid patients and presumably (multiple speakers). Any number, any colors on that?

好的聽起來不錯。也許這裡的最後一個問題是，當您推出產品時，您預計會有任何患者參與手術嗎？換句話說，他們成為付費患者並且大概是（多個發言者）。有數字、顏色嗎？

Yeah, so we were having the conversations with sites or had the conversation with sites varies by site that we plan -- that we'd like to transition our EAP patients over to commercial patients once commercial supply is available, with the exception, of course, if a patient doesn't have coverage, we wouldn't stop treating them. That the way we set up the protocol is it's not an automatic, we can't force that and there are some important reasons why we chose not to set it up so that we could force it. But I don't know whether or not it will be a third or half, but there'll be some meaningful percentage of the patients that we'll treat in the first quarter, will be patients who switch over from EAP.

是的，所以我們正在與站點進行對話，或者與站點的對話因我們計劃的站點而異——一旦商業供應可用，我們希望將我們的 EAP 患者轉為商業患者，當然，例外情況，如果患者沒有保險，我們不會停止治療他們。我們設定協議的方式不是自動的，我們不能強制它，並且有一些重要原因為什麼我們選擇不設定它以便我們可以強制它。但我不知道是否會達到三分之一或一半，但我們將在第一季治療的患者中，有一定比例的患者是從 EAP 轉過來的。

Okay. That's very helpful and thanks a lot for the details and congrats again. Congrats on the progress.

好的。這非常有幫助，非常感謝您提供的詳細信息，並再次祝賀。祝賀取得的進展。

Thanks so much, Yale.

非常感謝，耶魯。

Swayampakula Ramakanth, H.C. Wainwright.

拉瑪坎特 (Swayampakula Ramakanth)，H.C.溫賴特。

Thank you. This is [RK] from H.C. Wainwright. In terms of getting centers ready when you start launching the drug, the kit in January, -- are you getting a feel for like how long it's taking for some of these doctor, teams, and the surgery teams in terms of training so that they can start doing surgeries? And also, how do you think that changing time is going to evolve as you launch and more of the physician teams start training?

謝謝。我是 H.C. 的 [RK]。溫賴特。當你在一月份開始推出藥物和套件時，讓中心做好準備——你是否感覺到這些醫生、團隊和手術團隊需要多長時間進行培訓，以便他們可以開始做手術嗎？另外，您認為隨著您的啟動以及更多的醫生團隊開始培訓，時代的變化將如何演變？

Yeah, so in terms of how long it really varies, we have one site that immediately jumped on it and got their preceptorship done within a month or so, having a discussion with maybe a month or two having a discussion with them. We have other sites that, again, I've used the term on multiple calls or one-on-ones, herding cats, where it's been very difficult to get an interventional radiologists and anesthesiologists and a profusionist all attending a case at the same time, with carriers and airplane flight, et cetera. So I think that's one of the reasons why I'm saying, look, we'll probably have 11 sites, well planning on having 11 sites preceptored, hopefully within about two months plus.

是的，所以就其真正變化的時間而言，我們有一個網站立即跳上它並在一個月左右的時間內完成了他們的指導，與他們進行了可能一兩個月的討論。我們還有其他網站，我再次在多次通話或一對一、放貓時使用過這個術語，在這些網站上，很難讓介入放射科醫生、麻醉科醫生和專業人員同時處理一個病例，與航空公司和飛機飛行等等。所以我認為這就是我說的原因之一，看，我們可能會有 11 個站點，並精心規劃了 11 個站點，希望在大約兩個月內完成。

But of those, I think five will end up getting proctored. But then we have to look at a team of experienced stocks, and right now that's just Moffitt, because we have a requirement that they need to have done a certain number. In the recent past, the Moffitt's the only one that checks up that box as well as some European sites. We expect there'll be some issues with getting an experienced site to precept at the site. So that will be the second gating item. Again, it's going to be tough to predict, that's why we're saying out of the 11 that we think will have attended preceptorships, maybe five will get onboard. And we can't really decide which, but we don't know exactly which five it will be.

但其中，我認為有五個最終會被監考。但我們必須看看一支經驗豐富的股票團隊，現在只有莫菲特，因為我們要求他們必須完成一定的數字。最近，莫菲特是唯一檢查該框以及一些歐洲站點的地方。我們預計，讓經驗豐富的站點來指導該站點會出現一些問題。這將是第二個門控項目。同樣，這將很難預測，這就是為什麼我們說，在我們認為將參加導師培訓的 11 人中，也許有 5 人會​​加入。我們無法真正決定是哪五個，但我們也不知道到底是哪五個。

Thereafter, as more sites do more cases and more sites that have beyond the, I think it's 10 cases they have to do before they can be a proctor? Once they get beyond the 10 cases, all of a sudden, we'll have multiple experienced sites that can proctor. And I think towards the back end of next year, that's when that will really accelerate and that will be a lot simpler to get sites up and up and running. So very hard to predict it will take a lot much longer in the beginning of this year than it will towards the end -- the beginning of next year -- then it will take towards the end of next year as more and more sites are available to be proctors. So hopefully that answers the question, RK, which just basically it depends.

此後，隨著越來越多的網站做更多的案例，越來越多的網站已經超越了，我認為他們必須做 10 個案例才能成為監考人員？一旦超過 10 個案例，我們就會突然擁有多個可以監考的經驗豐富的站點。我認為到明年年底，這將真正加速，網站的啟動和運行將變得更加簡單。因此很難預測今年年初的時間會比年底（明年初）花費的時間要長得多，然後隨著越來越多的站點可用，到明年年底就會花費更多的時間成為監考人員。希望這能回答 RK 問題，基本上取決於情況。

Yeah, no, I got that. And then in terms -- how do you see and hospitals and even doctors trying to get on achievement ceiling that HEPZATO KIT versus [kintract]? And when we go into how some of these conversations, what funded nations do you end up having? Or do you think you will be able to [ and Al Kildani of six fifteens] to move from contract to HEPZATO KIT?

是的，不，我明白了。然後，您如何看待醫院甚至醫生試圖達到 HEPZATO KIT 與 [kintract] 的成就上限？當我們討論其中一些對話時，最終會得到哪些資助國家？或者你認為你能夠[和六個十五的阿爾·基爾達尼]從合約轉到HEPZATO KIT？

Yeah, I think, well -- Kevin why don't you give an example from a commercial rep perspective? What will the conversation be?

是的，我想，凱文，你為什麼不從商業代表的角度舉例呢？對話會是什麼？

Yeah, I don't think that we will replace kintract with the HEPZATO KIT. The conversations that we've had in the field right now have revolved around your potential to use the two therapies in sequence. What's the best sequence? How can how can they complement each other? Ultimately, these patients are probably going to go at least on two lines of treatment, if not three. So what is the order that is going to provide these patients with the best options and, ultimately, the longest overall survival. So that's where the conversations have been really focusing around, not so much on the either or between HEPZATO KIT or kintract.

是的，我不認為我們會用 HEPZATO KIT 取代 kintract。我們目前在該領域進行的對話圍繞著您依次使用這兩種療法的潛力。最好的順序是什麼？他們怎樣才能互補呢？最終，這些患者可能至少接受兩種（甚至三種）治療。那麼什麼順序才能為這些患者提供最佳選擇，並最終獲得最長的總存活期。因此，這才是對話真正關注的焦點，而不是 HEPZATO KIT 或 kintract 之間的任何一個。

All right, that's good to hear. Thank you.

好吧，很高興聽到這個消息。謝謝。

Yeah, I think it's also important to remember, and I think everyone on this call does remember this, but kintract is indicated for about 40% to 45% of the overall population. So this is a subset of patients that we -- this conversation is pertinent to. But I think everybody knows that, but worth highlighting.

是的，我認為記住這一點也很重要，我認為參加這次電話會議的每個人都記得這一點，但 kintract 適合總體人口的 40% 到 45% 左右。所以這是我們這次談話相關的一部分患者。但我想每個人都知道這一點，但值得強調。

Thanks, Gerard. Thanks for taking my questions.

謝謝，傑拉德。感謝您回答我的問題。

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

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

Okay. Well, I want to thank everyone for taking the time this afternoon. I look forward to providing future updates regarding our launch, and subsequent to that, our commercial update. Thank you, everyone, and have a good evening.

好的。好吧，我要感謝大家今天下午抽出時間。我期待著提供有關我們發布的未來更新，以及隨後的商業更新。謝謝大家，祝大家晚上愉快。

The 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。您現在可以斷開連線。