Delcath Systems Inc (DCTH) 2024 Q2 法說會逐字稿

Greetings, and welcome to Delcath Systems' second-quarter 2024 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Delcath Systems 的 2024 年第二季財報電話會議。（操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Mr. David Hoffman, Delcath General Counsel. Thank you. Mr. Hoffman, you may begin.

現在我很高興向您介紹主持人，Delcath 總法律顧問 David Hoffman 先生。謝謝。霍夫曼先生，您可以開始了。

Thank you. And once again, welcome to Delcath Systems' second quarter 2024 earnings and business highlights 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; Vojislav Vukovic, Chief Medical Officer; and Martha Rook, Chief Operating Officer.

謝謝。再次歡迎參加 Delcath Systems 2024 年第二季財報與業務亮點電話會議。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； Vojislav Vukovic，首席醫療官；和首席營運長瑪莎·魯克。

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, may be 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.

我想在通話開始時閱讀安全港聲明。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陳述均可被視為 1933 年《證券法》第 27A 條和 1934 年《證券交易法》第 21E 條含義內的前瞻性陳述。

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.

儘管該公司認為這些前瞻性聲明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聲明中明示或暗示的結果有重大差異。

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.

有關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 以及公司不時向證券交易委員會提交的其他報告中。

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.

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。

Our press release with our second quarter 2024 results is available on our website, www.delcath.com, under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website.

我們的 2024 年第二季業績新聞稿可在我們的網站 www.delcath.com 的「投資者」部分查看，其中包括有關我們財務業績的更多詳細資訊。我們的網站上還有我們最新的 SEC 文件，我們鼓勵您查看。今天的通話錄音將在我們的網站上提供。

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

現在我想把電話轉給傑拉德·米歇爾。杰拉德，請繼續。

Thank you, everyone for joining. During today's call we will review Delcath's second-quarter financial results, our ongoing commercial activities, including projections for both site activation and average treatment rates for the balance of the year, as well as some important medical and clinical updates.

謝謝大家的加入。在今天的電話會議中，我們將回顧 Delcath 第二季度的財務表現、我們正在進行的商業活動，包括今年餘下時間的站點激活和平均治療率的預測，以及一些重要的醫療和臨床更新。

In the second quarter, Delcath reported $7.8 million in total revenue, including $6.6 million in US revenue from HEPZATO and $1.2 million in European revenue for CHEMOSAT. As we have previously described, the key drivers of our revenue ramp in the US are center activation and once activated, the average number of treatment per center.

第二季度，Delcath 報告總收入為 780 萬美元，其中 HEPZATO 在美國的收入為 660 萬美元，CHEMOSAT 在歐洲的收入為 120 萬美元。正如我們之前所描述的，我們在美國收入成長的關鍵驅動因素是中心的激活以及一旦激活，每個中心的平均治療次數。

From a high level, we are thrilled with our overall progress in terms of our ramp and we're very, very encouraged about what the coming quarters will bring. Now to be specific, in terms of site activation, we ended the second quarter with seven active sites and as of today, we have eight active sites. While this fell just below the number we projected in our last call, the treatment rate of just under two per month per center is well ahead of our previously communicated projected rate.

從較高的層面來看，我們對我們在成長方面的整體進展感到興奮，並且我們對未來幾季將帶來的結果感到非常非常鼓舞。具體來說，就站點啟動而言，我們在第二季結束時有七個活躍站點，截至今天，我們有八個活躍站點。雖然這個數字略低於我們在上次電話會議中預測的數字，但每個中心每月不到兩名的治療率遠高於我們先前公佈的預測率。

I'd like to dig a little deeper into both metrics, and turn first to center activation. While activation has been a bit slower at some centers than anticipated, there is no systemic reason for the increase in time for center activation, but instead it's just simply a function of the complexity of activating a center given the number of stakeholders involved. It's important to note that we haven't seen any center in the activation process halt the process.

我想更深入地研究這兩個指標，並首先轉向中心激活。雖然某些中心的激活速度比預期要慢一些，但中心激活時間的增加並沒有系統性的原因，而只是考慮到涉及的利益相關者數量，激活中心的複雜性的函數。值得注意的是，我們沒有看到任何中心在啟動過程中停止該過程。

From our ongoing conversations with the centers, we are confident that all of the centers that are in process, which today stands at over 20 centers beyond our active currently active sites, will be active in 2025. The eight active centers include Moffitt Cancer Center, Stanford University Cancer Center, Thomas Jefferson University, University of Wisconsin, Regional One Health or University of Tennessee, UCLA Cancer Center, the University of North Carolina Hospital, and HonorHealth Scottsdale.

根據我們與這些中心的持續對話，我們相信所有正在建設中的中心（目前除了我們目前活躍的站點之外還有 20 多個中心）都將在 2025 年投入使用。這八個活躍中心包括莫菲特癌症中心、史丹佛大學癌症中心、托馬斯傑斐遜大學、威斯康辛大學、Regional One Health 或田納西大學、加州大學洛杉磯分校癌症中心、北卡羅來納大學醫院和 HonorHealth 斯科茨代爾。

Two additional centers having completed all the required preceptorships and have each scheduled their first treatment this month. Assuming no cancellations we should end the August with 10 treatment centers.

另外兩個中心已經完成了所有必需的指導，並各自安排了本月的第一次治療。假設沒有取消，我們應該在 8 月結束時擁有 10 個治療中心。

An additional four centers have completed the necessary steps to conduct their first commercial treatment under the guidance of a proctor and are currently in the process of identifying and scheduling a patient for proctor treatment with HEPZATO KIT. As I've mentioned in the past, that can be a complex scheduling algorithm given all the proctors that need to arrive as well as that fit with the patients' needs as well.

另外四個中心已完成必要步驟，在監考人員的指導下進行首次商業治療，目前正在確定並安排患者接受 HEPZATO KIT 的監考人員治療。正如我過去提到的，考慮到所有需要到達的監考人員以及適合患者需求的情況，這可能是一個複雜的調度演算法。

A further eight centers are currently completing a portion of the preceptorship requirements. To date, we have had over 130 perfusionists, anesthesiologists and interventional radiologists attend preceptorships, representing over 20 institutions in the US, with some institutions sending multiple health care providers. We are confident that the 12 centers that are currently in the process of activating will successfully activate within the next six months.

另外八個中心目前正在完成部分導師要求。迄今為止，我們已有 130 多名灌注師、麻醉師和介入放射科醫生參加了培訓，代表美國 20 多個機構，其中一些機構還派出了多名醫療保健人員。我們有信心目前正在啟動的 12 個中心將在未來六個月內成功啟動。

Now I'd like to dig a little into a second metric. Average treatments per center which has been higher than we projected during our last call. Adjusting for the date of center activation, the average treatment by center was just under two per month in the second quarter. Not surprisingly, some centers have notably greater volumes than others. But given the commitment required to become a REMS-certified active treating center, we believe that the vast majority of treatment centers either currently active or undergoing the activation process will become meaningful revenue contributors.

現在我想深入研究第二個指標。每個中心的平均治療次數高於我們上次電話會議期間的預期。根據中心啟動日期進行調整後，第二季中心每月的平均治療量略低於兩次。毫不奇怪，有些中心的交易量明顯大於其他中心。但考慮到成為 REMS 認證的主動治療中心所需的承諾，我們相信，目前活躍或正在進行激活過程的絕大多數治療中心將成為有意義的收入貢獻者。

We started the third quarter with seven active sites, with eight active sites present today, as I mentioned before, we anticipate we can end the third quarter with 12 active sites. We expect to reach 15 early in the fourth quarter and anticipate having 20 centers by the end of 2024 or shortly thereafter.

我們在第三季開始時有 7 個活躍站點，今天有 8 個活躍站點，正如我之前提到的，我們預計第三季結束時會有 12 個活躍站點。我們預計在第四季初將達到 15 個中心，並預計到 2024 年底或不久後將擁有 20 個中心。

While HEPZATO treatments in the second quarter averaged just under two treatments per month for the active treating centers, adjusted for when center started treating patients, we estimate treatments will average between 1.5 to 2 treatments per center for the balance of the year, somewhat under the second quarter average, but above what we projected in our last call. This is based in part on a pattern we are seeing where some centers treat an initial group of patients and then pause for a month or more before treating additional patients.

雖然活躍治療中心第二季度的HEPZATO 治療平均每月不到兩次，但根據中心開始治療患者的時間進行調整，我們估計今年剩餘時間每個中心的平均治療次數將在1.5 至2 次之間，略低於第二季度平均水平，但高於我們上次電話會議中的預測。這在一定程度上是基於我們所看到的一種模式，即一些中心治療最初的一組患者，然後暫停一個月或更長時間，然後再治療其他患者。

Besides assessing patient outcomes, the pause provides an opportunity for our centers to evaluate the explanation of benefits from payers before approving a steady flow of patients. As many of you know, this is a common dynamic for the rollout of premium innovative new procedures and therapies within hospitals, even in situations such as ours, where the product has the benefit of a product-specific J-Code, which greatly reduces risk of underpayment.

除了評估患者的治療結果之外，暫停還為我們的中心提供了一個機會，在批准穩定的患者流動之前評估付款人對福利的解釋。正如你們許多人所知，這是在醫院內推出優質創新新程序和療法的常見動力，即使在像我們這樣的情況下，產品具有產品特定的 J 代碼的優勢，從而大大降低了風險付款不足的情況。

Some of you may have seen this morning's press release in which we shared that on August 1 we were informed by CMS that we were granted New Technology Add-on Payment status for HEPZATO, effective for starting October 1, 2024. This additional payment under NTAP designation will help cover the costs associated with the treatment for the small percentage of Medicare patients that might require inpatient stay.

你們中的一些人可能已經看到了今天早上的新聞稿，其中我們分享了 8 月 1 日 CMS 通知我們已獲得 HEPZATO 新技術附加付款狀態，該狀態自 2024 年 10 月 1 日起生效。NTAP 指定的這筆額外付款將有助於支付一小部分可能需要住院的 Medicare 患者的治療相關費用。

As a reminder, most patients do not end up being billed as inpatient. And thus, for those Medicare billed patients in an outpatient basis, the product is reimbursed to the hospital under J-Code at ASP plus 6%.

提醒一下，大多數患者最終不會被列為住院患者。因此，對於門診按 Medicare 收費的患者，該產品可根據 J 代碼以 ASP 加 6% 的價格向醫院報銷。

Given the pace of revenue ramp, we continue to expect that we will achieve $10 million in quarterly US revenue by the fourth quarter of this year, which is expected to trigger approximately $25 million in cash proceeds from the exercise of the remaining tranche of warrants that were issued as part of our financing in March 2023.

鑑於收入成長的步伐，我們繼續預計，到今年第四季度，我們將在美國季度實現 1000 萬美元的收入，預計這將透過行使剩餘部分認股權證帶來約 2500 萬美元的現金收益。於2023 年3 月融資的部分發行。

CHEMOSAT sales in Europe have increased over 100% over the same period prior year. The majority of the growth is from Germany and as a result of having a dedicated commercial presence in the market for over a year. We're in the process of submitting for reimbursement in the UK and we now understand that review will take place next year.

CHEMOSAT 在歐洲的銷售額比去年同期成長了 100% 以上。大部分成長來自德國，這是由於一年多來在市場上專注的商業存在。我們正在英國提交報銷申請，現在我們了解到審核將於明年進行。

While we estimate approximately 40% of all Metastatic Uveal Melanoma patients in the Netherlands are being treated with CHEMOSAT those patients are almost all being treated as part of the ongoing CHOPIN trial. We have started commercial sales in Sweden, but expect most patients to enroll in an IIT we are sponsoring there looking at sequencing IPI+NIVO with CHEMOSAT, which I will describe in greater detail in a moment.

雖然我們估計荷蘭所有轉移性葡萄膜黑色素瘤患者中約有 40% 正在接受 CHEMOSAT 治療，但這些患者幾乎都是作為正在進行的 CHOPIN 試驗的一部分接受治療。我們已經在瑞典開始商業銷售，但預計大多數患者會參加我們在那裡贊助的 IIT，研究使用 CHEMOSAT 對 IPI+NIVO 進行測序，我稍後將對此進行更詳細的描述。

We are early in the process of identifying and opening commercial centers in France, Italy, and Spain. We believe it is important to have multiple treating centers in all major European markets. But as I've mentioned before, we are being measured in our investment given the low price point in Europe and have chosen to manage the EU market on a breakeven basis.

我們正處於在法國、義大利和西班牙尋找和開設商業中心的早期階段。我們認為在所有主要歐洲市場擁有多個治療中心非常重要。但正如我之前提到的，考慮到歐洲的低價點，我們正在衡量我們的投資，並選擇在損益兩平的基礎上管理歐盟市場。

Recall that CHEMOSAT has a broader pan solid tumor device label and some of our European sites have over a decade's worth of experience with CHEMOSAT. The value of Europe in the short to medium term is as trial sites a source of publications, both in Metastatic Uveal Melanoma and other tumor types. These activities can support both EU and US adoption.

回想一下，CHEMOSAT 擁有更廣泛的泛實體瘤設備標籤，並且我們的一些歐洲站點在 CHEMOSAT 方面擁有十多年的經驗。歐洲中短期的價值在於作為試驗地點和出版物的來源，無論是轉移性葡萄膜黑色素瘤或其他腫瘤類型。這些活動可以支持歐盟和美國的採用。

In addition to the significant commercial activity, we continue to support both internal and external efforts to add to the 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 as well as potentially other liver-dominant cancers. In the second quarter, we announced the publication of key results from the pivotal Phase 3 FOCUS trial of HEPZATO in patients with unresectable metastatic uveal melanoma in the journal Annals of Surgical Oncology.

除了重要的商業活動之外，我們還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 提供的美法崙還是HEPZATO KIT 都是肝病患者的重要治療選擇顯性葡萄膜黑色素瘤以及其他潛在的以肝臟為主的癌症。第二季度，我們宣佈在《外科腫瘤學年鑑》雜誌上發表了針對不可切除的轉移性葡萄膜黑色素瘤患者的 HEPZATO 關鍵 3 期 FOCUS 試驗的關鍵結果。

We expect additional results from the FOCUS study to be presented and published the coming months. For example, an efficacy analysis in clinically important subgroups of patients in FOCUS study has been accepted as a poster presentation at the upcoming ESMO Conference in September. As we continue to roll out commercial use of HEPZATO in the US, we are also engaging medical oncologists in the US and EU to discuss integration of HEPZATO into treatment algorithms and combination sequencing with available treatment options in Metastatic Uveal Melanoma.

我們預計 FOCUS 研究的更多結果將在未來幾個月內公佈和發表。例如，FOCUS 研究中臨床重要患者亞群的療效分析已被接受為 9 月即將舉行的 ESMO 會議的海報展示。隨著我們繼續在美國推出 HEPZATO 的商業用途，我們也與美國和歐盟的醫學腫瘤學家合作，討論將 HEPZATO 整合到轉移性葡萄膜黑色素瘤的治療演算法中以及與現有治療方案的組合測序。

There is significant interest in the medical community to evaluate HEPZATO in different treatment settings. As an example, I would like to point to a recent single-case publication, published in Frontiers in Oncology on successful treatment of a metastatic uveal melanoma patient with CHEMOSAT following failure on immune checkpoint inhibitors and tebentafusp.

醫學界對在不同治療環境中評估 HEPZATO 表現出濃厚的興趣。作為一個例子，我想指出最近發表在《腫瘤學前沿》上的一篇單例出版物，內容是在免疫檢查點抑制劑和 tebentafusp 失敗後使用 CHEMOSAT 成功治療轉移性葡萄膜黑色素瘤患者。

As I mentioned a moment ago, we're expecting a new IIT to enroll and start treatments of patients in Sweden this quarter. This IIT will evaluate sequencing immune checkpoint inhibitors, ipilimumab, and nivolumab or Ipi+Nivo followed by CHEMOSAT treatment, and compare against therapy with Ipi+Nivo as the control.

正如我剛才提到的，我們預計新的 IIT 將在本季在瑞典註冊並開始對患者進行治療。此 IIT 將評估免疫檢查點抑制劑、易普利瑪 (ipilimumab) 和納武單抗 (nivolumab) 或 Ipi+Nivo 隨後進行 CHEMOSAT 治療的定序，並與 Ipi+Nivo 作為對照的治療進行比較。

This IIT is the second IIT, the first being CHOPIN, which evaluates Ipi+Nivo first in sequence with CHEMOSAT, with CHEMOSAT as a control. In discussions with medical oncologists, we are aware that physicians and patients are very interested in exploring HEPZATO or CHEMOSAT in combination with immunotherapy based on a body of published evidence of possible synergies between chemotherapy and immune therapy in solid tumors.

該 IIT 是第二個 IIT，第一個是 CHOPIN，它首先使用 CHEMOSAT 依次評估 Ipi+Nivo，並以 CHEMOSAT 作為對照。在與腫瘤內科醫師的討論中，我們意識到醫生和患者對探索 HEPZATO 或 CHEMOSAT 與免疫療法的結合非常感興趣，基於已發表的大量實體瘤化療和免疫療法之間可能存在協同作用的證據。

We have heard multiple anecdotal reports of physicians utilizing CHEMOSAT and immunotherapy in combination or sequence without waiting for the completion and publication of the CHOPIN study results. On that note, the CHOPIN study continues to progress with 70 of the total planned 76 patients enrolled. Currently, the investigators are anticipating final analysis of the primary endpoint to occur in mid-2025, with presentation of results in the second half of 2025.

我們聽到了許多關於醫生在未等待 CHOPIN 研究結果完成和發布的情況下聯合或依次使用 CHEMOSAT 和免疫療法的軼事報告。就這一點而言，蕭邦研究仍在繼續取得進展，並計劃招募 76 名患者中的 70 名。目前，研究人員預計主要終點的最終分析將於 2025 年中期進行，並於 2025 年下半年公佈結果。

As a reminder, the primary endpoint of the CHOPIN trial is progression-free survival at one year. This analysis depends on collecting the appropriate number of events so the time lines for data readout by definition are somewhat uncertain.

提醒一下，CHOPIN 試驗的主要終點是一年內的無惡化存活期。此分析取決於收集適當數量的事件，因此根據定義讀取資料的時間軸有些不確定。

We continue to plan to initiate one or more clinical studies of HEPZATO CHEMOSAT in an additional indication over the next six months and recently conducted two scientific advisory boards focused on colorectal and breast cancer to better define the development path. We will provide updates on our clinical development plan later this year.

我們繼續計劃在未來六個月內啟動一項或多項HEPZATO CHEMOSAT 的額外適應症臨床研究，並最近舉辦了兩個專注於結直腸癌和乳腺癌的科學顧問委員會，以更好地確定開發路徑。我們將在今年稍後提供臨床開發計劃的最新資訊。

I will now hand the call over to Sandra to share some details on our financial position. Sandra?

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. Revenue from our sales of HEPZATO were $6.6 million and CHEMOSAT were $1.2 million for the three months ended June 30, 2024, compared to $0.5 million for CHEMOSAT during the same period in 2023. Our gross margins were 80% in the second quarter.

謝謝你，傑拉德。截至 2024 年 6 月 30 日的三個月，HEPZATO 的銷售收入為 660 萬美元，CHEMOSAT 的銷售收入為 120 萬美元，而 2023 年同期 CHEMOSAT 的銷售收入為 50 萬美元。第二季我們的毛利率為80%。

For the three months ended June 30, 2024, research and development expenses were $3.4 million, compared to $3.6 million for the three months ended June 30, 2023. The change in research and development expenses is primarily due to a decrease in clinical trial activities offset by an increase in personnel-related expenses in medical affairs and regulatory costs associated with an improved product.

截至2024年6月30日止三個月，研發費用為340萬美元，截至2023年6月30日止三個月為360萬美元。研發費用的變化主要是由於臨床試驗活動的減少被醫療事務中人員相關費用的增加以及與改進產品相關的監管成本的增加所抵消。

For the three months ended June 30, this year compared to the same period in 2023, selling, general and administrative expenses increased to $6.8 million from $4.8 million. The increase is due to activity for commercial launch, including marketing-related expenses and additional personnel on the commercial team.

截至 6 月 30 日的三個月，與 2023 年同期相比，銷售、一般和管理費用從 480 萬美元增加至 680 萬美元。增加的原因是商業發布活動，包括行銷相關費用和商業團隊的額外人員。

We ended Q2 with $19.9 million in cash and investments and cash used in operations was approximately $4.5 million in the second quarter. On August 1, the loan with Avenue fully matured and final payment was made. We believe that our current financial resources are adequate to fund operations until the company achieve $10 million in US quarterly revenue, which would likely trigger a warrant exercise resulting in $25 million of proceeds.

第二季末，我們擁有 1,990 萬美元的現金和投資，第二季營運中使用的現金約為 450 萬美元。8月1日，Avenue貸款全部到期並支付尾款。我們相信，我們目前的財務資源足以為公司的營運提供資金，直到公司在美國的季度收入達到 1000 萬美元，這可能會觸發認股權證行使，從而產生 2500 萬美元的收益。

This $25 million should be sufficient to fund the company until we become cash flow positive under current levels of research and development expenses. As Gerard previously mentioned, we remain confident we will achieve $10 million in US quarterly revenues by the fourth quarter of this year.

這 2500 萬美元應該足以為公司提供資金，直到我們在目前的研發費用水準下實現正現金流。正如傑拉德之前提到的，我們仍然有信心到今年第四季我們將在美國實現 1000 萬美元的季度收入。

That concludes our prepared remarks, and I'd ask the operator to open the phone lines for Q&A. Can you please check for questions?

我們準備好的演講到此結束，我請接線生打開電話線路問答。您能檢查一下有問題嗎？

(Operator Instructions) John Newman, Canaccord Genuity.

（操作員說明）John Newman，Canaccord Genuity。

Hi, there. Congratulations on the quarter and thank you for taking my question. I know it's still a bit early in the launch, but could you comment on what you're seeing in terms of the mean number of treatments for HEPZATO. And just kind of curious as to how you would expect that trend to progress over the next, say, 12 to 24 months. Thanks.

你好呀。恭喜本季度，感謝您提出我的問題。我知道現在發布還為時過早，但您能否評論一下您所看到的 HEPZATO 平均治療次數。只是有點好奇您預計這種趨勢在接下來的 12 到 24 個月內會如何發展。謝謝。

Sure. So it's anecdotal at best given, we're really getting this from the reps and the clinical support specialists who are in most of the procedures. But it seems like most patients are progressing on to two, three, four, or five or more.

當然。因此，這充其量只是軼事，我們確實是從參與大多數程序的代表和臨床支援專家那裡得到的。但似乎大多數患者的病情進展到兩個、三個、四個、五個或更多。

It's too early now to say whether or not they'll match what we saw in the trial, which was 4.1 on average. But I suspect we'll do at least that well over time. But no indication that it will be lower than that at this point.

現在判斷它們是否符合我們在試驗中看到的平均 4.1 還為時過早。但我懷疑隨著時間的推移我們至少會做得很好。但沒有跡象表明它會低於目前的水平。

Okay. Great. If I could sneak in one additional question. It seems like there's a lot of potential for HEPZATO beyond the additional approval. You spoke a bit about additional trials beyond CHOPIN. Just curious, do you expect that those trials would be sort of smaller single-arm studies or would you expect that maybe some of those studies might also have controller? Thanks.

好的。偉大的。如果我能再問一個問題的話。除了額外的批准之外，HEPZATO 似乎還有很大的潛力。您談到了蕭邦以外的其他試驗。只是好奇，您是否認為這些試驗將是小型單臂研究，或者您認為其中一些研究也可能有控制器？謝謝。

Yeah. I think, we're going to do a mix of things. So [Vojo] right now is working with both advisory committees to think through larger randomized studies with control arms, as well as single and multicenter investigator-initiated trials. And those would probably more likely be single arm, although some of those have the control as well.

是的。我想，我們會做一些混合的事情。因此，[Vojo] 目前正在與兩個諮詢委員會合作，思考使用對照組進行的更大規模的隨機研究，以及由研究者發起的單中心和多中心試驗。儘管其中一些也具有控制能力，但它們更可能是單臂。

So I think you'll see a mix of things from us, ranging from sponsored trials that are randomized and have a control arm. We might think some trials, we have some trials in mind that would look at historical data. So a single arm with a control arm to increase specified like a registry data, for example. So it will be a mix of things.

所以我想你會從我們這裡看到各種各樣的東西，從隨機贊助的試驗到有對照組的試驗。我們可能會考慮一些試驗，我們考慮一些會查看歷史資料的試驗。所以單臂與控制臂要增加指定的類似註冊表數據，例如。所以這將是各種事情的混合。

And the goal, again, will be a mix as well. The goal will be ranging from giving adequate data, so physicians can make an informed judgment for certain patients whether or not they want to treat and try to get reimbursed for the patients to informing potential guidelines down the road, all the way to trying to expand the label. So it will be a mix.

同樣，目標也將是混合的。目標包括提供足夠的數據，以便醫生可以對某些患者做出明智的判斷，判斷他們是否想要治療並嘗試為患者獲得報銷，告知未來可能的指導方針，一直到嘗試擴大範圍標籤。所以這將是一個混合。

Great, thank you.

太好了，謝謝。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Hi, Gerard. Hi, Sandra. Very nice quarter, this quarter. Wanted to dig a little bit on the average treatment per center metric. Thank you for giving us that detail. If we were to strip out the highest volume center, I don't know if it's still Moffitt, I know it was last quarter.

嗨，傑拉德。嗨，桑德拉。這個季度非常好。想深入了解每個中心指標的平均治療情況。感謝您向我們提供如此詳細的資訊。如果我們要去掉銷售量最高的中心，我不知道它是否仍然是莫菲特，我知道那是上個季度。

Is there a way to think about the average for kind of that remaining group? And you mentioned that they are pausing just to check on billing and things. Is everything going smoothly on that front? I know with the J-Code going into effect, that was, of course, supposed to help quite a bit.

有沒有辦法考慮剩餘群體的平均值？你提到他們暫停只是為了檢查帳單和其他事情。這方面一切進展順利嗎？我知道，隨著 J 程式碼的生效，這當然應該會有很大幫助。

Yeah, let me answer the second question first. I have heard of no fundamental problem with reimburse with the hospitals when they do things right. I have heard of a couple of cases where they've done things wrong and they've had to go back and fix it and then get paid. But if they do things right, they get paid. And if they don't, they always have the opportunity to go back, which takes a little bit longer.

是的，我先回答第二個問題。我聽說，只要醫院做得正確，報銷就不存在根本問題。我聽說過一些案例，他們做錯了事，不得不回去改正，然後獲得報酬。但如果他們做對了事情，他們就會得到報酬。如果他們不這樣做，他們總是有機會回去，這需要更長的時間。

So no fundamental issue there that I've seen at all. Everything has been very positive. In terms of the average treatment rates, I'm going to hesitate from giving, breaking it down to that level. I will say if you stripped out the Moffitts and the Thomas Jeffersons, yes, the average treatment per week would drop. But I do think most centers will eventually do at least two a month, and many will be more than that. Thomas Jefferson and of Moffitt clearly are bringing the averages up.

所以我根本沒有看到任何根本問題。一切都非常積極。就平均治療率而言，我會猶豫是否要給予，將其分解到這個水平。我想說的是，如果剔除莫菲特夫婦和托馬斯·傑斐遜夫婦，是的，每週的平均治療量將會下降。但我確實認為大多數中心最終每月至少會做兩次，而且許多中心會更多。托馬斯·傑斐遜和莫菲特顯然正在提高平均水平。

In addition, as new centers come on not all of them but many of them seem to do a couple of patients and wait and then start to hit the gas. So those new centers really will drive, I think, the downward pressure on the average, but maturing centers will keep the average kind of flat. So net-net, that's why I think it will be somewhere between 1.5 to 2 for the balance of the year.

此外，隨著新中心的出現，並不是所有的中心都投入使用，但其中許多中心似乎會先收治幾個病人，然後等待，然後開始全力以赴。因此，我認為，這些新的中心確實會推動平均水平的下行壓力，但成熟的中心將使平均水平保持穩定。因此，淨淨值，這就是為什麼我認為今年剩餘時間的淨值將在 1.5 到 2 之間。

Okay. That's really helpful. For a follow-up here, wanted to underscore how good your margins were this quarter both gross margins and OpEx control. Help us think about the sustainability of some of that.

好的。這真的很有幫助。作為後續跟進，我想強調一下你們本季的利潤率（毛利率和營運支出控制）有多好。幫助我們思考其中一些的可持續性。

Are you needing to add more sales reps to kind of keep up with your launch plans? Was there a reason the control is so good on the operating spend side? Just any more detail you can give us there. And thanks for taking the questions.

您是否需要增加更多銷售代表來跟上您的發布計劃？營運支出方面的控制權如此之好是否有原因？您可以在那裡向我們提供更多詳細資訊。感謝您提出問題。

Sure. I think we're fairly disciplined on the OpEx side. A lot of the players here have come from another similar company who kind of know, spend money wisely. We don't need a huge sales force to reach all the centers, this is going to be a specialty product that has small number centers.

當然。我認為我們在營運支出方面相當有紀律。這裡的許多玩家來自另一家類似的公司，他們知道如何明智地花錢。我們不需要龐大的銷售隊伍來到達所有中心，這將是一個擁有少量中心的特色產品。

I think in the past, I talked about maybe getting to 25 to 30. Our thinking is evolving there. We might decide to get to more like 35 or 40 that might have a marginal increase on SG&A relative to where we are now, but not a huge increase.

我想過去我談到可能會達到25到30。我們的思維在那裡不斷發展。我們可能會決定增加到 35 或 40 左右，這可能會導致 SG&A 相對於我們現在的水平略有增加，但不會大幅增加。

In terms of cost of goods, we're great for three, four years before we have to do any meaningful tie-up of CapEx, I believe. So we're in good shape there. So I think the biggest variable really is and I might be preempting a question is R&D spend. How much do we decide that we want to invest into R&D?

我相信，就商品成本而言，在我們必須對資本支出進行任何有意義的合作之前，我們會在三、四年內保持良好狀態。所以我們在那裡狀況良好。所以我認為最大的變數其實是研發支出，我可能會先提出一個問題。我們決定在研發上投資多少？

And we're going to be very thoughtful about that. But there's no doubt we will increase R&D at some point for some additional trials. We'd be remiss if we didn't because this product has tremendous potential in many other much larger indications.

我們將對此進行深思熟慮。但毫無疑問，我們會在某個時候增加研發，進行一些額外的試驗。如果我們不這樣做，那就是失職了，因為該產品在許多其他更大的適應症中具有巨大的潛力。

But I'm not going to kind of forecast what that's going to be 1.5 years out from now. I'll just say, look, we're going to try to be very prudent. And we understand there's an E in EPS and I mean, and that's an EPS, excuse me, in terms of number of shares. So we're going to be very prudent to try to keep the cost down, so really don't have to raise much more money going forward.

但我不會預測 1.5 年後會發生什麼事。我只想說，看，我們會盡量保持謹慎。我們知道每股盈餘中有一個 E，我的意思是，這是每股盈餘，對不起，以股票數量來表示。因此，我們將非常謹慎地努力降低成本，因此未來實際上不必籌集更多資金。

Very good. Thank you.

非常好。謝謝。

Swayampakula Ramakanth, H.C. Wainwright.

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

Thank you. Good afternoon. Regarding the center activations, now that you have eight centers activated or almost 10 by the end of this month. What are the learnings from, if there's any push or pull on it? And how is that helping you not only educate internally, but also the preceptors so that the next set of activations go smooth?

謝謝。午安.關於中心的激活，現在已經有8個中心被激活，到本月底已經有近10個中心被激活。如果有任何推動或拉動，從中可以學到什麼？這不僅能幫助你進行內部教育，還能幫助導師們順利進行下一組活化？

Yeah. I don't think there's any dramatic learnings aside from we need to address project stakeholders in parallel and really help try to educate some of the stakeholders in the hospitals and get ahead of the various committee approvals and stuff.

是的。我認為除了我們需要同時解決專案利益相關者的問題，並真正幫助嘗試教育醫院中的一些利益相關者並獲得各個委員會的批准和其他東西之外，我不認為有任何戲劇性的教訓。

The preceptorship training stuff is really just a Rubik's cube of scheduling. As we get further along and we have more proctors available and people who can do preceptorships, it will get a bit easier. But right now, it's just difficulty in scheduling. Kevin, I don't know if you want to chime in about any learnings in terms of site activation, preceptorship or anything like that.

導師培訓其實只是日程安排的魔術方塊。隨著我們的進一步發展，我們有更多的監考人員和可以擔任導師的人，事情會變得更容易一些。但現在，只是安排上有困難。凱文，我不知道你是否想插話一下在網站啟動、指導或類似方面的任何學習。

Sure. Thanks, Gerard. Gerard, I like the analogy, the Rubik's cube of scheduling. And to the more sites that we have active and the more procedures that we have, it lessens the or it increases, I should say, it increases the opportunities for preceptorships and proctorships. So in that respect, it should make the account activation cycle a bit easier.

當然。謝謝，傑拉德。傑拉德，我喜歡這個比喻，也就是日程安排的魔術方塊。對於我們擁有的活躍網站越多，我們擁有的程式越多，它就會減少或增加，我應該說，它會增加指導和監考的機會。因此，在這方面，它應該使帳戶啟動週期變得更容易一些。

The other thing or 8 to 10 centers that we're working with right now, it allows for peer-to-peer conversations that kind of happen organically behind the scenes. So physicians call each other and hospitals do for some manner of checking on reimbursement and understanding how to set things up. So the net-net of all of this is that, when these centers will help us and should kind of streamline the activation process as we go forward in the second half of the year.

我們現在正在與 8 到 10 個中心合作，它允許在幕後有機地進行點對點對話。因此，醫生會互相打電話，醫院也會以某種方式檢查報銷情況並了解如何安排。因此，所有這一切的最終結果是，這些中心將幫助我們，並且在我們下半年前進時應該簡化啟動過程。

Thank you. Regarding the NTAP that you received, that HEPZATO KIT received just earlier this month, how does that benefit in terms of adoption? And would that help in any way in terms of increasing the number of procedures per center?

謝謝。關於您收到的 NTAP（HEPZATO KIT 本月早些時候收到的 NTAP），它對採用有何好處？這對增加每個中心的手術數量有什麼幫助嗎？

Yeah, I don't think getting NTAP is going to make much of a difference in terms of uptake. I think, it is helpful for the hospitals when they have the infrequent inpatients. It will lessen the financial burden on the hospital. It's a rather complex formulary they have to have a certain loss amount, then it covers a certain percentage, up to a certain percentage, which I don't think it's worth going into that level of detail because I don't think is that critical.

是的，我認為獲得 NTAP 不會對採用率產生太大影響。我認為，對於住院病人較少的醫院來說，這是有幫助的。這將減輕醫院的經濟負擔。這是一個相當複雜的處方，他們必須有一定的損失金額，然後它涵蓋一定的百分比，最高可達一定的百分比，我認為不值得深入探討這一細節，因為我認為這並不那麼重要。

I think the most important thing or telling thing is it's more of a sign of how innovative this therapy truly is. People look at it's melphalan, it's a device, et cetera, but the bar to get the new technology add-on payment is pretty high. You really do need to prove that you're an innovative therapy and doing something that nothing else does is out there.

我認為最重要的事情或最有說服力的事情是，它更多地表明了這種療法的真正創新性。人們認為它是馬法蘭，它是一種設備，等等，但獲得新技術附加付款的門檻相當高。你確實需要證明你是一種創新療法，並且正在做一些其他人無法做到的事情。

And I think it's fantastic that we got it. And I think, although it seems unrelated, the physician reaction we're getting from the radiologists and oncologists who are using the product the response rate they're seeing they're incredibly positive.

我認為我們能得到它真是太棒了。我認為，儘管這看起來無關，但我們從使用該產品的放射科醫生和腫瘤科醫生那裡得到的醫生反應以及他們看到的反應率非常積極。

So it's just shows that again, this is a filter, it's old school chemo. It is truly something new that's making a real difference for patients. And I think that's why we got the NTAP. It is a modest tailwind, but it's not that big of a deal. We don't need it.

所以這再次表明，這是一個過濾器，這是老式的化療。這確實是一種新事物，能夠為患者帶來真正的改變。我認為這就是我們制定 NTAP 的原因。這是一個溫和的順風，但沒什麼大不了的。我們不需要它。

Thank you. One last question from me on the UK reimbursement since the couple of hospitals, if I remember correctly, from the UK that have used CHEMOSAT for a longer time than others, how is that going to play into the reimbursement review when it comes time?

謝謝。我關於英國報銷的最後一個問題是，如果我沒記錯的話，英國的幾家醫院使用 CHEMOSAT 的時間比其他醫院更長，到了報銷審查的時候，這將如何發揮作用？

Yeah, I have no doubt we're going to get reimbursement. They went from a semiannual review to an annual review. That was a surprise to us. That's what pushed it back into next year. That just was a recent change in how often they do the review. But we'll get reimbursement, I have no doubt about that. The question is, what will the reimbursement be?

是的，我毫不懷疑我們會被報銷。他們從半年審查變成了年度審查。這對我們來說是一個驚喜。這就是將其推遲到明年的原因。這只是他們最近進行審查的頻率的變化。但我們會得到報銷，我對此毫不懷疑。那麼問題來了，報銷的金額是多少呢？

I don't have high hopes, that it will be a significant step up from where we are right now. But again, as I mentioned before, we're going to manage Europe on a roughly breakeven basis. But we're going to continue to invest in there on a measured basis because I think it's as clinical sites and a source to generate publications, it's a very, very important strategic asset for the company.

我並沒有抱太大希望，這將是我們現在的進步的重大進步。但正如我之前提到的，我們將在大致損益平衡的基礎上管理歐洲。但我們將繼續在有衡量的基礎上進行投資，因為我認為它作為臨床場所和生成出版物的來源，對公司來說是非常非常重要的策略資產。

Perfect. Thank you very much, Gerard.

完美的。非常感謝你，傑拉德。

Sudan Loganathan, Stephens Inc.

蘇丹洛加納森史蒂芬斯公司

Hi, Gerard, Sandra, and Delcath team, congrats on a great quarter. I have two questions. My first one is regarding the marketing strategy. Is the main focus geared towards selling the kit to hospitals to bring on more additional sites or trying to focus them more towards the patient and physician awareness? And then as you go into next year and progress this launch, will there be any changes to that marketing strategy?

嗨，傑拉德、桑德拉和德爾卡斯團隊，恭喜你們度過了一個精彩的季度。我有兩個問題。我的第一個是關於行銷策略。主要重點是向醫院出售該套件以引入更多額外站點，還是試圖讓它們更專注於患者和醫生的意識？然後，當你進入明年並推進這次發佈時，行銷策略會有任何變化嗎？

And then secondly, what quarterly and yearly revenue run rate in OpEx range do you anticipate you need to be at to achieve a breakeven or positive EPS? I understand you might also have aspirations and other indications for the HEPZATO, but is getting to breakeven or cash flow positive or at least a track towards that a potential goal to achieve prior to taking on new clinical endeavors?

其次，您預計營運支出範圍內的季度和年度收入運行率需要達到多少才能實現盈虧平衡或正每股收益？我知道您可能也對 HEPZATO 有願望和其他適應症，但是在進行新的臨床努力之前，實現盈虧平衡或現金流量是否為正，或者至少是實現這一目標的一個潛在目標？

Sure. I think, Sandra, why don't you pick up where you think we need to be at to hit breakeven, okay, on a quarterly basis, under current R&D spend?

當然。我想，桑德拉，你為什麼不選擇你認為我們需要達到盈虧平衡的地方，好吧，在當前的研發支出下，按季度計算？

Yeah. Currently, probably around the 60 to 80 kits, just depending a quarter in order to be breakeven or cash flow positive and we obviously dependent on additional SG&A, marketing spend, and R&D that will be incurred the rest of this year. But I think we're well on the course of becoming cash flow positive, hopefully, by Q1 of 2025.

是的。目前，可能大約有 60 到 80 套套件，只需要一個季度就能實現盈虧平衡或現金流為正，而且我們顯然依賴今年剩餘時間將產生的額外 SG&A、行銷支出和研發。但我認為我們預計在 2025 年第一季實現正現金流。

And that's about $30 million a quarter in revenue.

每季的收入約為 3000 萬美元。

Yep.

是的。

All right. Now in terms of the FOCUS market, I mean right now, I think, Kevin, chime in if you disagree, we're probably FOCUS is 80% site activation, 20% trying to get patients to the sites. That will switch over time, but all elements of the marketing mix are important at the moment. Kevin, maybe I don't know if you want to give a couple of word, couple of sentences about our priorities now and how that might evolve over the next year, 1.5 years.

好的。現在就 FOCUS 市場而言，我的意思是現在，凱文，如果您不同意，請插話，我們可能 FOCUS 是 80% 的站點激活，20% 試圖讓患者訪問這些站點。這會隨著時間的推移而改變，但目前行銷組合的所有要素都很重要。凱文，也許我不知道你是否願意用幾句話來談談我們現在的優先事項以及未來一年（1.5 年）的發展。

Sure. And I think with the patient population that we have right now, one of our main goals is to that 20% is to drive awareness and increase patient access to what we think is a wonderful option for these patients. And while opening sites is important, it's not our main goal. Our main goal is not to open as many sites as we can.

當然。我認為，就我們目前擁有的患者群體而言，我們的主要目標之一是提高這 20% 的患者意識並增加患者獲得我們認為對這些患者來說是絕佳選擇的機會。雖然開放網站很重要，但這不是我們的主要目標。我們的主要目標不是打開盡可能多的網站。

As Gerard pointed out in his remarks, we've started with a goal of 20 and with our ultimate goal of probably roughly around 40 sites. And it's more the quality of sites. Are we going to the correct sites? Are we giving patients access at these sites? So that's been our focus, opening the right sites and getting patients access to those sites.

正如 Gerard 在他的演講中指出的那樣，我們一開始的目標是 20 個站點，最終目標可能是大約 40 個站點。更多的是網站的品質。我們是否造訪了正確的網站？我們是否允許患者存取這些站點？所以這就是我們的重點，打開正確的網站並讓患者訪問這些網站。

Thanks. Appreciate it.

謝謝。欣賞它。

(Operator Instructions) Chase Knickerbocker, Craig-Hallum Capital Group.

（操作員指示）Chase Knickerbocker，Craig-Hallum Capital Group。

Good afternoon, everyone. Thanks for taking the questions. Just first from me, are there any other high-end early adopters in the pipeline kind of like Moffitt or Thomas Jefferson? Or should we think of kind of everyone else from here as those that maybe pause a bit after a couple of patients and generally drag down that average kits per center per month number over the first quarter or so of them being active?

大家下午好。感謝您提出問題。首先我想問一下，是否有其他高端早期採用者，例如莫菲特或託馬斯·傑斐遜？或者我們是否應該將這裡的其他人視為那些在幾個患者之後可能會暫停一下的人，並且通常會在第一季度左右的活躍時間里拉低每個中心每月的平均試劑盒數量？

I think there's a third surprise center to us that I wouldn't say that they're at that level but might approach it given some recent activity. And I think there'll be a number of others that will reach that level. And I think some of the centers were opening that weren't at that level in terms of a book of business, once they have our treatments they will increasingly become kind of a destination for a lot of patients.

我認為我們還有第三個驚喜中心，我不會說他們處於那個水平，但考慮到最近的一些活動，他們可能會接近它。我認為還有很多其他人會達到這個水平。我認為一些正在開業的中心在業務方面還沒有達到那個水平，一旦他們接受了我們的治療，他們將越來越成為許多患者的目的地。

So I don't think we're going to have a ton of centers doing six a week. But will we end up having quite, I mean, six a month, excuse me. Will we end up having quite a few centers that are doing maybe one a week and quite a few centers being more than four or five. Yeah, I think so, eventually.

所以我不認為我們會有很多中心每週做六次。但我們最終會得到相當多的，我的意思是，每月六個，對不起。我們最終會不會有相當多的中心每週做一次，還有相當多的中心每週做一次以上，或超過四到五個。是的，我想最終是這樣。

So if you look at the kind of the Pareto analysis of centers, those are the big guys who you mentioned. But I think a lot of centers, once they have our therapy, will end up treating patients maybe that aren't appropriate for our therapy, but they're going to start bringing them in. So they'll start becoming destinations.

所以，如果你看看中心的帕累托分析，那些就是你提到的大人物。但我認為許多中心一旦接受了我們的治療，最終將治療可能不適合我們治療的患者，但他們將開始將他們引入。所以他們將開始成為目的地。

Should we think of kind of a max level kind of per week treatments that some of those high adopters could do? I mean any way for us to think about that of what the constraint is on the high end? And then second, of the centers that are awaiting that initial commercial treatment scheduling, do we get a sense of kind of how long it takes to activate those patients?

我們是否應該考慮一些高採用者可以進行的每週最高水準的治療？我的意思是我們有什麼方法可以思考高端的限制是什麼？其次，在等待初始商業治療安排的中心中，我們是否了解激活這些患者需要多長時間？

I know we gave a lot of numbers on the call, so forgive me if I'm making you repeat yourselves. But just those four, for example, that were just awaiting the schedules to line up, do we have a general feel for how long that takes?

我知道我們在電話中提供了很多號碼，所以如果我讓你們重複一遍，請原諒我。但就這四個人來說，他們只是在等待時間表排列，我們是否對這需要多長時間有一個總體感覺？

No, it's been all over the map. And that's why I was off of it in my projections. I thought we'd have 10 by the end of last quarter and we didn't. We had seven, now we're at eight and in about three or four weeks, we should be at a two or three weeks, we should be attentive, if nobody, a patient doesn't get a call, then all the proctors can show up, et cetera. It really is all over the map.

不，地圖上到處都是。這就是為什麼我的預測偏離了它。我以為到上季末我們就會有 10 個，但沒有。我們有七個，現在我們是八個，大約三到四個星期後，我們應該是兩到三週，我們應該專心，如果沒有人，病人沒有接到電話，那麼所有監考人員都可以出現，等等等。它確實遍布地圖。

In terms of what you think of what is a max or run rate, we have a couple of centers in Europe that, if it's not summer vacation, were doing pretty regularly on a week. And that seems to be kind of a natural high volume rate for centers, although we had one center recently do three in one day, believe it or not. So that center may end up being a six a month, seven a month type place.

就你所認為的最高或運行率而言，我們在歐洲有幾個中心，如果不是暑假，它們每週都會定期運行。對於中心來說，這似乎是一種自然的高容量率，儘管我們最近有一個中心一天要做三個，不管你信不信。因此，該中心最終可能會成為每月六次、每月七次的地方。

So I think as people get used to this or are willing to train a second team or have a couple of backup people, they might end up doing six or seven a month. But right now, I think four months will likely be what the high end does for a bit and others are going to be one or two a month.

所以我認為，當人們習慣了這一點或願意培訓第二支團隊或有幾個後備人員時，他們最終可能會每月做六到七個。但現在，我認為高端產品可能會持續四個月，而其他產品則每月一到兩個月。

I think eventually we'll see some sites that it regularly do one to two a week. But that will take a bit of time. And again, we saw a center just the other I think two weeks ago, that did last week, they did three and one day. So they were able to push them through.

我想最終我們會看到一些網站每周定期做一到兩次。但這需要一些時間。再一次，我們看到了一個中心，我想是兩週前的另一個中心，上週，他們做了三天，有一天。所以他們能夠推動他們渡過難關。

Got it. That's helpful color. And then just last for me. Just maybe speak to a little bit about, I know it's early, but the progress that you're having in the community kind of driving referrals to some of these centers. And then maybe kind of an early look at how your therapy is going to interact with those patients that are eligible for tebentafusp. Are those kind of patients who are eligible getting tebentafusp first or is this something where physicians are viewing it kind of in-line treatment? Just kind of give me an early look there.

知道了。這是有用的顏色。然後就對我來說最後一次。也許只是談談，我知道現在還為時過早，但是社區中取得的進展推動了對其中一些中心的推薦。然後也許可以儘早了解您的治療將如何與那些適合接受 tebentafusp 的患者相互作用。那些有資格首先接受 tebentafusp 的患者，還是醫生認為這是一種線上治療？只是讓我早點看看那裡。

We've had patients before tebe and we've had patients after tebe. And it really has more to do with whether the doc believes that liver directed therapy should go first because this liver meds are usually what these patients succumb to. So if they're going to prioritize treatment, some docs want to prioritize liver-directed therapy.

在泰貝之前我們有病人，在泰貝之後我們也有病人。這確實與醫生是否認為應該先進行肝臟導向治療有關，因為這些肝臟藥物通常是這些患者屈服的原因。因此，如果他們要優先考慮治療，有些醫生希望優先考慮肝臟導向治療。

So it's all over the map, and it will settle out over time probably one way or another. But most patients do live long enough to get more than one line of therapy. So whether they go first on tebe or first on us, I think, patients who are HLA2 positive should get both. It's probably the right thing for the patients.

所以它遍布整個地圖，並且隨著時間的推移，它可能會以這樣或那樣的方式解決。但大多數患者確實活得夠長，可以接受不只一種治療。因此，我認為，無論他們首先使用 tebe 還是先使用我們，HLA2 陽性的患者都應該同時使用兩者。對於患者來說，這可能是正確的事。

In terms of referrals, it's still early days. Vojo's team and Kevin's team are both working on, Vojo's medical affairs team and Kevin's commercial team are both working on setting up referral patterns. We've had, I don't know, quite a few referrals to date. They're usually peer-to-peer referrals.

就推薦而言，現在還處於早期階段。Vojo 的團隊和 Kevin 的團隊都致力於建立轉診模式。我不知道，到目前為止，我們已經收到許多推薦了。他們通常是點對點推薦。

So a lot of times, we've been getting referrals from centers that are waiting to finish their preceptorships or finishing up their the various approval committees they need to have. They have a patient they want to have treated. They send them to another site, knowing the patient is going to come back to them, hopefully, once the fall of the approvals occur at their centers. So we've seen those peer-to-peer referrals. And we've also sent some patients directly due to phone calls we've made in such 100 treating sites.

所以很多時候，我們一直從等待完成他們的指導或完成他們需要的各種批准委員會的中心得到推薦。他們有一位想要治療的病人。他們將他們送到另一個地點，知道一旦他們的中心的批准下降，患者就會回到他們身邊。所以我們已經看到了那些點對點推薦。我們也透過電話在這100個治療點直接送了一些病人。

In terms of a good, well-oiled machine referral process, we're developing that right now. That's something that will become increasingly important. We're confident we can do it. It's going to evolve a lot of direct patient things work through advocacy centers. The advocacy groups are very excited about the product. So we'll work with them so the patients know where this is available.

就良好、運作良好的機器推薦流程而言，我們現在正在開發它。這將變得越來越重要。我們有信心我們能做到。它將透過倡導中心發展許多直接的患者工作。倡導團體對該產品非常興奮。因此，我們將與他們合作，以便患者知道哪裡可以獲得這種藥物。

We have reasonable data as to who's treating these patients. So we know who has just one of them, just two of them, just free of them and we have developed a process where through e-mails, phone calls, perhaps surprise visits, we try to get in front of these docs to tell them about HEPZATO KIT.

我們有關於誰在治療這些患者的合理數據。所以我們知道誰只有其中一個，只有兩個，只是沒有它們，我們開發了一個流程，透過電子郵件、電話、也許是突擊拜訪，我們試圖到達這些文件面前告訴他們關於 HEPZATO 套件。

Because each of these patients is so valuable, it makes sense to cut down to that level of N equals one, N equals two or three. But we recognize the importance of that, we're also developing programs where the patient has a reason to get directly in touch with a third party that we work with. Maybe it's help with co-pays, travel, et cetera.

由於這些患者中的每一個都非常有價值，因此將 N 減少到等於 1、N 等於 2 或 3 的水平是有意義的。但我們認識到這一點的重要性，我們也正在開發一些項目，讓患者有理由直接與我們合作的第三方聯繫。也許它可以幫助支付自付費用、旅行等等。

But through that process, we'll probably get involved with docs who have smaller numbers of patients. And that will help us with referrals there. So it's going to be a kind of a multi-spoke effort. Still early days to declare, say how well it's working, but we are going to be focused on that.

但透過這個過程，我們可能會接觸到患者數量較少的醫生。這將幫助我們在那裡進行推薦。因此，這將是一種多方努力。宣布它的效果如何還為時過早，但我們將重點關注這一點。

Got it. Thanks, and congrats again on the great early progress there.

知道了。謝謝，並再次恭喜早期取得的巨大進展。

Thank you.

謝謝。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。