Delcath Systems Inc (DCTH) 2025 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good day and welcome to the Delcath Systems first quarter, 2025 earnings call. All participants are in listen-only mode. There will be an opportunity to ask questions at the end of the formal presentation. (Operator Instructions)

    大家好,歡迎參加 Delcath Systems 2025 年第一季財報電話會議。所有參與者都處於只聽模式。正式演講結束時將有機會提問。(操作員指示)

  • I'd now like to turn the conference over to Mr. David Hoffman, Delcath 's General Counsel. Just go ahead, sir.

    現在我想將會議交給 Delcath 的總法律顧問 David Hoffman 先生。請繼續,先生。

  • David Hoffman - Chief Compliance Officer, General Counsel, Corporate Secretary

    David Hoffman - Chief Compliance Officer, General Counsel, Corporate Secretary

  • Thank you and once again, welcome to Delcath Systems first quarter 2025 earnings and Business highlights call. With me on the call are Gerard Michel, the Chief Executive Officer, Sandra Pennell, Chief Financial Officer, Kevin Muir, General Manager, Interventional Oncology, Vojislav Vukovic, Chief Medical Officer, and Martha Rook, Chief Operating Officer.

    謝謝大家,再次歡迎大家參加 Delcath Systems 2025 年第一季財報和業務亮點電話會議。與我一起參加電話會議的還有執行長 Gerard Michel、財務長 Sandra Pennell、介入腫瘤科總經理 Kevin Muir、首席醫療官 Vojislav Vukovic 和首席營運長 Martha Rook。

  • 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 1,995. 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.

    我想先讀安全港聲明。本聲明根據 1995 年《私人證券訴訟改革法案》中所述的前瞻性陳述的安全港條款作出。本次電話會議中所做的所有陳述(歷史事實除外)均可視為《1933 年證券法》第 27A 條和《1934 年證券交易法》第 21E 條所定義的前瞻性陳述。

  • 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.

    儘管公司認為這些前瞻性聲明中反映的預期和假設是合理的,但它並不保證這些預期將被證明是正確的。

  • Actual results may differ in a material manner from those expressed or implied in forward-looking statements due to various risks and uncertainties.

    由於各種風險和不確定性,實際結果可能與前瞻性陳述中表達或暗示的結果有重大差異。

  • For a discussion of such risk 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 10K, those contained in subsequently filed quarterly reports on Form 10Q, as well as 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表達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 10K 表年度報告中詳細列出的風險因素、隨後提交的 10Q 表季度報告中包含的風險因素以及公司不時向美國證券交易委員會提交的報告。

  • 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.

    本次電話會議中包含的任何前瞻性陳述僅截至本次電話會議之日有效。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 first quarter 2025 results is available on our website under the investor 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 2025 年第一季業績新聞稿可在我們網站的投資者部分查閱,其中包含有關我們財務業績的更多詳細資訊。我們的網站還提供我們最新的 SEC 文件,我們鼓勵您查看。今天的電話會議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。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Thank you for joining us today to review our first quarter's financial results and business updates. I'm proud of our continued progress this quarter in terms of both revenue growth and incremental center openings. Both HEPZATO and CHEMOSAT have had an impressive first quarter of 2025, generating a combined revenue of $19.8 million.

    感謝您今天加入我們,回顧我們第一季的財務表現和業務更新。我為我們本季在營收成長和中心開幕增量方面取得的持續進步感到自豪。HEPZATO 和 CHEMOSAT 在 2025 年第一季都取得了令人印象深刻的成績,總收入達 1,980 萬美元。

  • HEPZATO sales in the US contributed $18 million while moat sales in Europe added $1.8 million. Thanks to the exceptional efforts of our commercial team, we entered the quarter with 17 treating sites and have since opened an initial 2 centers, bringing our total to 19 active centers in the US.

    HEPZATO 在美國貢獻了 1800 萬美元的銷售額,而在歐洲則貢獻了 180 萬美元的銷售額。由於我們商業團隊的出色努力,我們在本季度擁有 17 個治療點,隨後開設了最初的 2 個中心,使我們在美國的活躍中心總數達到 19 個。

  • In the first quarter, we continued to solidify the company's finances with positive cash on operations of $2.2 million and an income of $1.1 million. A positive adjusted EBITDA of $7.6 million. Additionally, we ended the quarter with no debt and approximately $59 million in cash and investments.

    第一季度,我們繼續鞏固公司的財務狀況,經營現金流為 220 萬美元,收入為 110 萬美元。調整後的 EBITDA 為正 760 萬美元。此外,本季結束時我們沒有債務,且擁有約 5,900 萬美元的現金和投資。

  • With this strong financial footing, we will continue to leverage cash from operations to support HEPZATO's research and development initiatives beyond metastatic melanoma patients. Given our belief that HEPZATO and the underlying hepatic delivery system platform has the potential to benefit a much broader set of patients suffering from cancer in the liver.

    憑藉強大的財務基礎,我們將繼續利用營運現金來支持 HEPZATO 在轉移性黑色素瘤患者以外的研發計劃。我們相信 HEPZATO 及其底層肝臟輸送系統平台有可能使更廣泛的肝癌患者受益。

  • Turning back to center activations in the first quarter, we activated the University of Kansas Health System, Cleveland Clinic, and Providence Saint John's. So far in the second quarter, we activated Northwestern Memorial Hospital and the University of Miami. In addition to the 19 active treating centers, there are currently 10 centers now accepting referrals and pending activation.

    回顧第一季的中心活化情況,我們啟動了堪薩斯大學健康系統、克利夫蘭診所和普羅維登斯聖約翰醫院。到目前為止,在第二季度,我們已經啟動了西北紀念醫院和邁阿密大學。除了 19 個活躍的治療中心外,目前還有 10 個中心正在接受轉診並等待活化。

  • With our pace of opening between $0.3 to $0.5 centers per quarter, I am confident that we are well on track to achieve our previously stated goal of 30 active centers by year end. In the first quarter, we averaged approximately two treatments per month per center and based on the expected pace of new center activations and mix of existing centers, we expect the average monthly treatment per site to be just under two for the remainder of the year.

    我們每季開設 0.3 到 0.5 個中心的速度,我相信我們有望實現先前提出的年底前開設 30 個活躍中心的目標。在第一季度,我們平均每個中心每月進行約兩次治療,根據新中心啟動的預期速度和現有中心的組合,我們預計今年剩餘時間內每個站點的平均每月治療次數將略低於兩次。

  • As we increase our footprint across the United States, we are expanding from four to six territories, with each territory having a liver directed therapy manager, an oncology manager, and a clinical specialist. This transition transition to 6 territories is nearly complete, and we are successfully attracting top commercial talent across the United States to support our expansion.

    隨著我們在美國的業務範圍不斷擴大,我們的區域從四個擴展到六個,每個區域都有一名肝臟治療經理、一名腫瘤科經理和一名臨床專家。向 6 個地區的轉型已接近完成,我們正在成功吸引美國各地的頂尖商業人才來支持我們的擴張。

  • We continue to improve access for patients with metastatic uveal melanoma through our newly implemented HEPZATO KIT Access 360 platform. This comprehensive program connects patients with authorized HEPZATO KIT treatment centers and supports eligible patients in reducing their out-of-pocket costs.

    我們透過新實施的 HEPZATO KIT Access 360 平台持續改善轉移性葡萄膜黑色素瘤患者的治療機會。該綜合計劃將患者與授權的 HEPZATO KIT 治療中心聯繫起來,並支持符合條件的患者降低自付費用。

  • HEPZATO KIT access 360 also includes copay assistance for those with commercial insurance and also helps patients explore additional financial support available.

    HEPZATO KIT access 360 也為擁有商業保險的患者提供共付額援助,並幫助患者探索可用的額外財務支援。

  • The European market continues to growth, increasing 29% over the prior quarter to $1.8 million. As we have previously stated, given the reimbursement and pricing challenges in Europe, this market will not be a significant contributor to revenue, at least in the short to medium term.

    歐洲市場持續成長,較上一季成長 29%,達到 180 萬美元。正如我們之前所說,鑑於歐洲的報銷和定價挑戰,至少在短期到中期內,這個市場不會對收入產生重大貢獻。

  • However, given chemoSat holds a comprehensive pan solid tumor device label and several several of our European sites boast over a decade of experience with chemosat. The region has and will continue to be a critical source of clinical data.

    然而,鑑於 chemoSat 擁有全面的泛實體瘤設備標籤,並且我們的幾個歐洲站點擁有十多年的 chemosat 經驗。該地區已經並將繼續成為重要的臨床數據來源。

  • Turning to company sponsored trials, our clinical team is diligently working to establish sites for our liver dominant metastatic colorectal and metastatic breast cancer trials which represent a promising new indication for HEPZATO.

    談到公司贊助的試驗,我們的臨床團隊正在努力建立肝臟為主的轉移性大腸直腸癌和轉移性乳癌試驗的地點,這代表了 HEPZATO 的一個有希望的新適應症。

  • Our phase 2 trial and metastatic colorectal patients received FDA clearance in December of 2024. As a reminder, the phase 2 trial will evaluate the safety and efficacy of SOC in combination with standard of care versus standard of care alone in patients receiving third line treatment. Standard of care will be trifluridine-tipiracil and bevacizumab.

    我們的 2 期試驗和轉移性大腸直腸患者於 2024 年 12 月獲得 FDA 批准。提醒一下,第 2 階段試驗將評估 SOC 與標準治療相結合與單獨使用標準治療對接受三線治療的患者進行的安全性和有效性。標準治療為三氟尿苷-替吡嘧啶和貝伐單抗。

  • Our phase 2 trial of metastatic breast cancer received FDA clearance in April of this year. The phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination of standard of care versus standard of care alone in second- or third-line patients with liver dominant HER2 negative metastatic breast cancer. Data care options will be eribulin, vinorelbine or capecitabine.

    我們針對轉移性乳癌進行的 2 期試驗於今年 4 月獲得了 FDA 批准。此 2 期試驗將評估 HEPZATO 合併標準治療與單獨標準治療在肝顯性 HER2 陰性轉移性乳癌二線或第三線患者的安全性和有效性。數據護理選項將是艾日布林、長春瑞濱或卡培他濱。

  • Each trial will enroll approximately 90 patients across over 20 sites in the United States and Europe. Both trials have a primary endpoint of a panic progression free survival. We anticipate both studies starting by the end of 2025 with enrollment for the metastatic colorectal trial to begin the third or early fourth quarter, and enrollment for metastatic breast cancer to follow shortly thereafter.

    每次試驗將在美國和歐洲的 20 多個地點招募約 90 名患者。兩項試驗的主要終點都是無恐慌症惡化存活期。我們預計這兩項研究將於 2025 年底開始,轉移性大腸直腸癌試驗的招募將於第三季或第四季初開始,轉移性乳癌試驗的招募也將隨後開始。

  • For metastatic colorectal, we anticipate the primary endpoint to read out by the end of 2027 or early 2028, with overall survival data expected to follow in 2028. For our metastatic breast cancer trial, we project hepatic progression free survival data to be read out in late 2028 or early 2029, with overall survival data likely following in 2029.

    對於轉移性大腸直腸癌,我們預計主要終點將在 2027 年底或 2028 年初公佈,整體存活數據預計將在 2028 年公佈。對於我們的轉移性乳癌試驗,我們預期肝無惡化存活期資料將在 2028 年末或 2029 年初讀取,整體存活期資料可能在 2029 年讀取。

  • Our market research estimates at an annual addressable market of approximately 7,000 patients with liver dominant metastatic colorectal cancer advancing to third line treatment in the US, alongside a comparable population of approximately 7,000 patients with liver dominant metastatic breast cancer eligible for second- or third-line therapy.

    我們的市場研究估計,美國每年可獲得目標市場的肝轉移性結腸直腸癌患者約有 7,000 名,可獲得三線治療;同時,可獲得二線或三線治療的肝轉移性乳腺癌患者約有 7,000 名。

  • Each of these markets is approximately 7 times larger than the metastatic uveal melanoma patient population, which affects approximately 1,000 patients annually in the US.

    這些市場的規模都比轉移性葡萄膜黑色素瘤患者群體約 7 倍,每年美國約有 1,000 名患者患有轉移性葡萄膜黑色素瘤。

  • These substantial patient populations face a significant unmet needs as neither systemic therapies nor permanent liver directed therapies adequately address liver metastasis, understoring the urgent demand for innovative treatment options.

    由於全身性治療和永久性肝臟治療都無法充分解決肝轉移問題,因此這些龐大的患者群體面臨著巨大的未滿足需求,這反映了對創新治療方案的迫切需求。

  • Our strong start to 2025 was marked by consistent revenue growth and the expansion of active treatment centers adopting EPA. In the first quarter, we achieved both positive net income and operating cash flow, driven by robust clinical demand and accelerating adoption among oncologists and interventional radiologists.

    我們 2025 年的開局表現強勁,收入持續成長,採用 EPA 的活躍治療中心不斷擴張。在第一季度,我們實現了正淨收入和經營現金流,這得益於強勁的臨床需求以及腫瘤學家和介入放射科醫生的加速採用。

  • Our ongoing engagement with these specialists underscores the critical role of whole liver treatment in addressing liver dominant disease and forming our strategy to pursue additional invitations. These efforts position us to potentially transform care for a broader population of metastatic patients, including those with liver-dominant colorectal and breast cancer.

    我們與這些專家的持續合作強調了全肝治療在治療肝臟主導疾病和製定我們尋求更多邀請的策略方面的關鍵作用。這些努力使我們能夠潛在地改變更廣泛轉移性患者群體的治療方法,包括以肝癌為主的大腸癌和乳癌患者。

  • I'll now hand the call over to Sandra, who will provide a detailed overview of our financial performance.

    現在我將把電話交給桑德拉,她將詳細概述我們的財務表現。

  • Sandra Pennell - Senior Vice President - Finance, Chief Accounting Officer, Executive Officer

    Sandra Pennell - Senior Vice President - Finance, Chief Accounting Officer, Executive Officer

  • Thank you, Gerard. Revenue from our sales with HEPZATO was $18 million and CHEMOSAT was $1.8 million for the first quarter of 2025 compared to just $2 million for HEPZATO and $1.1 million for CHEMOSAT during the same period in 2024. We recognized gross margins at 86% in the first quarter compared to 71% for the same period in the prior year.

    謝謝你,傑拉德。2025 年第一季度,我們與 HEPZATO 的銷售收入為 1,800 萬美元,與 CHEMOSAT 的銷售收入為 180 萬美元,而 2024 年同期 HEPZATO 僅為 200 萬美元,與 CHEMOSAT 的銷售收入為 110 萬美元。我們第一季的毛利率為 86%,而去年同期為 71%。

  • Research and development expenses for the quarter were $5 million compared to $3.7 million for the same period the prior year. Selling general and administrative expenses for the first quarter were $11.3 million compared to $8.8 million for the same period in the prior year.

    本季研發費用為 500 萬美元,去年同期為 370 萬美元。第一季銷售總務及行政費用為 1,130 萬美元,去年同期為 880 萬美元。

  • Our first quarter 2025 net income was $1.1 million compared to 11.1 million net losses in the first quarter of the previous year.

    我們的 2025 年第一季淨收入為 110 萬美元,而去年第一季淨虧損為 1,110 萬美元。

  • Non-GAAP positive adjusted EBITA for the first quarter was $7.6 million compared to an adjusted EBITA loss of $7.3 million for the same period in 2024.

    第一季非公認會計準則調整後息稅折舊攤銷前利潤為 760 萬美元,而 2024 年同期調整後息稅折舊攤銷前利潤為虧損 730 萬美元。

  • As Gerard mentioned, we ended the quarter with approximately $59 million in cash and investments, positive operating cash flow of $2.2 million compared to a $1 million operating cash burden in the previous quarter.

    正如傑拉德所提到的,本季結束時,我們的現金和投資約為 5,900 萬美元,正營運現金流為 220 萬美元,而上一季的營運現金負擔為 100 萬美元。

  • As of today, we have no outstanding debt obligations and no outstanding warrants. The exercise of series F warrants resulted in $16.2 million of funding in 2025. The warrants were previously issued in May of 2020 as a component of a private placement, had an exercise price of $10 per share, and expired recently on May 5.

    截至今天,我們沒有未償還的債務,也沒有未償還的認股權證。F 系列認股權證的行使導致 2025 年融資 1,620 萬美元。該認股權證先前於 2020 年 5 月作為私募的一部分發行,行使價為每股 10 美元,並於 5 月 5 日到期。

  • Thank you all for participating today. That concludes our prepared remarks, and I'd ask the operator to open the phone lines for Q&A.

    感謝大家今天的參與。我們的準備好的演講到此結束,我想請接線生開通電話線路進行問答。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Thank you. We will now be conducting the question-and-answer session. (Operator Instructions)

    謝謝。我們現在將進行問答環節。(操作員指示)

  • Our first question comes from Chase Knickerbocker of Craig-Hallum Capital Group. Please go ahead.

    我們的第一個問題來自 Craig-Hallum Capital Group 的 Chase Knickerbocker。請繼續。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Good morning. Congrats on the strong results here, continued progress, and thank you for taking the questions.

    早安.恭喜您取得的優異成績和持續的進步,感謝您回答問題。

  • Just first on center ads, Gerard, you had previously said that you expect, the majority of ads to be in the second half of the year. I would say that this is, kind of stronger progress than we had expected. You've got visibility on a further 10.

    首先關於中心廣告,傑拉德,您之前曾說過,您預計大部分廣告將出現在下半年。我想說,這比我們預期的進展更為強勁。您可看到另外 10 個。

  • Can we add another two to three centers in Q2 here? I mean, do your kind of still stand by those comments that the majority of the ads will be in the second half, just kind of an update there.

    我們可以在 Q2 中再增加兩到三個中鋒嗎?我的意思是,您是否仍然堅持那些評論,即大多數廣告將出現在下半年,這只是一種更新。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • I think it will be a little more even throughout the year than I anticipated. As I've had a less than perfect track record in predicting. Center activations for some reason the hospitals don't always listen to our timing, but you know it is a solid queue. I know a few of those 10 will all of a sudden hit a barrier. I don't know what it will be that will slow them down.

    我認為全年的情況會比我預期的更均衡。因為我的預測記錄並不完美。由於某種原因,中心激活醫院並不總是聽從我們的時間安排,但你知道這是一個穩定的隊列。我知道這十個人中有幾個會突然遇到障礙。我不知道什麼會減慢他們的速度。

  • So, I'm on balance looking at I think 30 is about the right number to expect by the end of the year. Hope to do better, but I'm not going to bank on that.

    因此,總的來說,我認為 30 是今年年底預計的正確數字。希望做得更好,但我不會指望這一點。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • But so more even in the first half and so call it potential for two or three more of those centers in two to come on.

    但上半場的情況更為均衡,因此可以說下半場有兩到三名中鋒有潛力上場。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Yeah, I think so and I think it's going to be more of along the lines of, roughly four quarter, but again, very difficult, we're talking about small ends and complex processes, but yeah.

    是的,我是這麼認為的,而且我認為它將更接近大約四分之一,但同樣,非常困難,我們談論的是小目標和複雜過程,但是是的。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Got it. And has there been anything that's changed about the process? Any learnings that have kind of smoothed it out? And then you've got a little over two treatments per center per month in Q1. You'd said a little under two kinds of for the rest of the year.

    知道了。這個過程有什麼改變嗎?有什麼經驗可以幫助解決這個問題嗎?然後,在第一季度,每個中心每個月的治療次數略多於兩次。您說的是今年剩餘時間的兩種情況。

  • Can you just give us an update on kind of who these, centers are for the last 10? Do you expect them to be pretty, is there some pretty good potential adopters in there, and any reason why we we're going to see that a little bit of a decrease sequentially. From that Q1 treatments per center per month number.

    您能否向我們介紹一下過去 10 年這些中鋒的最新情況?您是否期望它們會很漂亮,其中是否有一些非常好的潛在採用者,以及我們為什麼會看到它們的數量環比略有下降。由此得出每個中心每月第一季的治療次數。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Yeah, there are some that we would hope would be a really high volume if you look at the script data who treats metastatic uveal melanoma in Miami should be theoretically a big center, legal clinic, etc. But what we found is even these centers with a lot of patients.

    是的,如果你查看腳本數據,我們希望其中一些的數量會非常高,在邁阿密治療轉移性葡萄膜黑色素瘤的人理論上應該是一個大的中心、合法診所等。但我們發現即使是這些中心也有很多病人。

  • It takes a while before they kind of start doing a lot. They'll do a few patients wait and see, and that wait and seek can take, when I say wait and see it doesn't stop, but they're not going to do a lot, and that could be like a six-month lag before they really hit their stride.

    他們要花一段時間才能開始做很多事情。他們會讓一些病人等待觀察,這種等待和尋求可能需要一些時間,當我說等待觀察時它不會停止,但他們不會做太多,這可能需要六個月的時間才能真正發揮作用。

  • So that's why I'm keeping the number, a little under two for the balance of the year and it's been pretty consistent since we launched. Just under two. Yeah, this first quarter, you're doing some quick math. It was it was about two, maybe a little over.

    所以這就是為什麼我將這個數字保持在今年剩餘時間略低於 2,而且自從我們推出以來,這個數字一直相當穩定。剛好不到兩點。是的,第一季度,你正在做一些快速的計算。大約是兩點,或稍微多一點。

  • But I think if we get the new continue to increase the pace of new centers, I think just under two is probably the right number. Now you would ask, are there any learnings I think we're getting better at anticipating.

    但我認為,如果我們繼續加快新中鋒的步伐,我認為略低於兩個可能是正確的數字。現在你可能會問,我認為我們是否能夠更好地預測任何學習成果。

  • Where there are hiccups and being much more aggressive to get the multiple stakeholders in the hospital or the center around the table and talk to them beforehand to try to preempt some of the barriers. So, on the margin, yeah, I think we've gotten better at it as we've learned, but still, there's just a lot of, uncontrollable variables that we have to deal with as they come up.

    當出現問題時,我們會更積極地讓醫院或中心的多個利害關係人坐下來,提前與他們交談,試圖預先消除一些障礙。所以,從邊際上來說,是的,我認為隨著我們學習的深入,我們已經做得更好了,但是仍然有很多不可控的變數需要我們去處理。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Got it. And just last for me, Sandra, as we think about kind of, basically asking kind of cadence of OpEx here, how we expect kind of R&D to ramp as these studies, ramp up and, connected with that, how are you thinking about EIA kind of through the year as those expenses ramp for the trials.

    知道了。最後,桑德拉,當我們思考的時候,基本上問的是這裡的營運支出的節奏,我們預計隨著這些研究的增加,研發支出也會增加,與此相關的是,隨著試驗費用的增加,您如何看待全年的 EIA。

  • Sandra Pennell - Senior Vice President - Finance, Chief Accounting Officer, Executive Officer

    Sandra Pennell - Senior Vice President - Finance, Chief Accounting Officer, Executive Officer

  • Yeah, so total OpEx, yes, we expect it to increase obviously over 2024 as you've already seen in Q1, 2025 SD&A for will increase probably 60% over 2024, and that includes our non-cash stock compensation. Stock comp is comprised about 35% of that.

    是的,總營運支出,是的,我們預計它將在 2024 年顯著增加,正如您在 2025 年第一季已經看到的那樣,SD&A 可能會在 2024 年增加 60%,其中包括我們的非現金股票薪酬。股票補償約佔其中的 35%。

  • Now R&D is expected to increase pro at a. Higher rate over 2024 around 150% again with stock com comprising about 20% of that 20% of that balance. In terms of EBITA, yeah, we had, EBITA margins of 30% this in in 11, there is no current target to maintain that that EBITA margin now in the near term and executing site opening and clinical trial initiatives, we should remain EBITA positive this year. Thank you.

    現在研發預計會增加。2024 年利率將再次上升至 150% 左右,其中股票佔該餘額的 20% 左右。就 EBITA 而言,是的,我們的 EBITA 利潤率在 11 年達到了 30%,目前沒有短期內維持該 EBITA 利潤率的目標,並且通過執行場地開放和臨床試驗計劃,我們今年的 EBITA 利潤率應該會保持為正值。謝謝。

  • Operator

    Operator

  • Our next question comes from Swayampakula Makanta of H.C. Wainwright. My apologies from HC Wainwright. Please go ahead.

    我們的下一個問題來自 H.C. 的 Swayampakula Makanta。溫賴特。我代表 HC Wainwright 向您道歉。請繼續。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thank you. This is okay from it, right, excellent quarter, it's all good on all fronts, in general. Oh, in terms of patients, undergoing procedures, are you seeing any repeat, procedures done on patients, over the period that it has been commercial so far, and also, in terms of.

    謝謝。從這一點來看還不錯,非常好的一個季度,整體來說,各方面都很好。哦,就患者接受手術而言,在迄今為止的商業化期間,您是否看到對患者進行任何重複的手術,此外,就…而言。

  • The centers coming on board, just trying to understand the cadence in the sense, are some of these centers. Kind of in that competitive situation where they feel they're within a certain geographic jurisdiction that they need to grab patience as soon as they can and some of them are you know in that in that process and that's why you're seeing this higher than expected, increase in terms of coming on board.

    加入的中心只是試圖從意義上理解節奏,是其中的一些中心。在這種競爭激烈的情況下,他們覺得自己處於某個地理管轄範圍內,需要盡快保持耐心,你知道,他們中的一些人正處於這個過程中,這就是為什麼你會看到這個數字高於預期,加入的數量有所增加。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Sure, in terms of your question about frequency of treatment in the clinical trial, it averaged 4.1 and it's as we look backwards, patients who came on board a year ago, six months ago, etc. It seems like we're going to be pretty much have exactly what happened in the trial or close to it.

    當然,關於您關於臨床試驗中治療頻率的問題,平均為 4.1,回顧一下,一年前、六個月前等加入試驗的患者。看起來我們幾乎會得到與試驗中完全一樣或接近的結果。

  • So, I think you know for those modeling four is a good number, '4.1 is a good number.it might bounce down to '3.9 at some point or up to '4.2 or '3, but it's definitely in that range and you know that is a big driver for overall revenues is how many treatments do these patients get.

    所以,我認為對於那些模型來說,4 是一個很好的數字,『4.1』是一個很好的數字。它可能會在某個時候反彈到‘3.9’或上升到‘4.2’或‘3’,但它肯定在這個範圍內,你知道這對整體收入是一個很大的驅動力,即這些病人得到了多少治療。

  • In terms of pace of opening, this is about what we expected it maybe it's a center over so but it's about what we expected in terms in terms of the pace. Our center is feeling, competitive pressure to get this.

    就開場速度而言,這大概是我們所預期的,也許它是一個中心,但就速度而言,這大概是我們所預期的。為了實現這一目標,我們的中心感受到了競爭壓力。

  • It's human nature. I'm sure there's a bit of, hey, XYZ center has it, so I need it as well. I think the biggest, the larger driver though is there aren't that many patients in this in this area. Nobody's really except perhaps Thomas Jefferson, nobody is, no one has a foundation of their practice based on Uveal of melanoma except outside of some Docs and Thomas Jefferson. So, they talk to each other and share information, and it's very collaborative across centers we've noted in this particular disease state.

    這是人的本性。我確信有一點,嘿,XYZ 中心有它,所以我也需要它。我認為最大的、更重要的驅動因素是該地區的病人並不多。除了托馬斯·傑斐遜之外,沒有人真正了解這一點,除了一些醫生和托馬斯·傑斐遜之外,沒有人有基於黑色素瘤葡萄膜的實踐基礎。因此,他們互相交談並分享訊息,而且我們注意到,在這種特殊的疾病狀態下,各個中心之間的協作非常緊密。

  • With docs and they're just hearing about good results, and I think that's the biggest driver, an IR or an oncologist speaks to another one at a conference, and they say what they're seeing with HEPZATO and that's the biggest driver for centers, wanting to bring the product on board.

    從醫生那裡聽說了好的結果,我認為這是最大的驅動力,IR 或腫瘤學家在會議上與另一位腫瘤學家交談,他們說出了他們對 HEPZATO 的看法,這是中心想要將產品引入的最大驅動力。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thanks for that, Gerard. 11 last questions from me on the European front, if I heard it correctly, the revenues were up 26%. But and but you're you're saying it's not a major contributor yet. I get that. But at the same time, every quarter we are watching that and it's kind of inching, higher and higher.

    謝謝你,傑拉德。我最後問了 11 個關於歐洲的問題,如果我沒聽錯的話,收入增加了 26%。但是,但是您說它還不是一個主要貢獻者。我明白。但同時,我們每季都在關注這一趨勢,而且它正在緩慢地、越來越高。

  • So, what is working there, and do you think you would want to put additional Resources, or you just want to wait for it to grow organically to a certain point before you start adding more resources. I know you're also looking for other countries to get reimbursement through and if there's any comments on that front.

    那麼,那裡在做什麼,您是否認為您想要投入額外的資源,或者您只是想等待它有機地增長到某個點,然後再開始添加更多資源。我知道您也在尋找其他國家來獲得報銷,並想知道您對此有何評論。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • So aside from, yeah, aside from Germany, there is no other reimbursement in Europe, and we hope to get reimbursed in the UK. We we've put our submission in and hopefully we get approval sometime this year and fund next year. The issue we have is twofold. One is when they look at the price of this, they include the costs of procedure.

    所以除了德國之外,歐洲沒有其他地方可以報銷,我們希望在英國獲得報銷。我們已經提交了申請,希望今年某個時候能獲得批准並在明年獲得資金。我們面臨的問題是雙重的。一是當他們考慮這個價格時,他們會把續費也算進去。

  • The second thing is when they come up with pricing they do look at the trial and they say this is a single arm trial we factor all that in. We don't think we're going to get much more than maybe a seventh of the US price which is roughly what we're doing now.

    第二件事是,當他們提出定價時,他們會考慮試驗,他們說這是一個單組試驗,我們將所有這些都考慮在內。我們認為,我們獲得的價格可能不會超過美國價格的七分之一,這大致就是我們現在的價格。

  • So you know whatever the tin is in the US. You kind of have to divide that let's say Europe's roughly equivalent, you have to divide that by seven. So, there's just less to go after at this price point. It's just not feasible to get the price point we have in the US and Europe.

    所以你知道美國的罐頭是什麼。你必須將其除以,比如說歐洲的大致相當數,你必須將其除以七。因此,在這個價位上,可供追求的東西就更少了。我們不可能達到美國和歐洲的定價水準。

  • I would invest more if there was, reimbursement that when we do get reimbursement, we will invest more in certain markets. But right now, I'm willing to do IITs and that sort of thing anywhere in Europe because it generates clinical data.

    如果有報銷的話,我會投入更多,當我們獲得報銷時,我們會在某些市場上投入更多。但現在,我願意在歐洲的任何地方進行 IIT 和類似的事情,因為它可以產生臨床數據。

  • I'm managing it roughly on a break-even basis, so you know we probably added three people in the last two years in Europe, which isn't a lot, but you know we're incrementally adding people when we think it'll do some good. But yeah, my focus in the in the short to medium term is let's get a lot of clinical data out of Europe.

    我大致上是在收支平衡的基礎上進行管理的,所以你知道我們可能在過去兩年裡在歐洲增加了三個人,雖然不是很多,但你知道,當我們認為這會帶來一些好處時,我們就會逐步增加人手。但是的,我短期到中期的重點是從歐洲取得大量臨床數據。

  • At some point an indication will come along at high enough volume with the right type of data to get better pricing and higher volume and reimbursement. That's probably not going to be with ule melanoma. Maybe it'll be with colorectal breasts or one of the other indications we'll pursue.

    在某個時候,當資料量足夠大且類型正確時,就會出現指示,以獲得更好的定價、更高的數量和報銷。這可能與黑色素瘤無關。也許它將與結直腸乳房有關,或者我們將要追求的其他適應症之一。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Yeah, so if I can, if I may one really one last question on the R&D front because you just talked about additional indications, so you, on the opening remarks, we did talk about the CRC and breast cancer, but at the same time I know since CHEMOSAT has been in Europe for a long time, are you seeing any additional indications that that the centers are wanting to do, especially with the liver metastasis in it, and if so, are, is that indication at a point where we can start, thinking about, or is it just too early?

    是的,如果可以的話,我真的很想問最後一個關於研發方面的問題,因為您剛才談到了額外的適應症,所以在開場白中,我們確實談到了 CRC 和乳腺癌,但與此同時,我知道由於 CHEMOSAT 已經在歐洲存在很長時間了,您是否看到了中心想要做的任何其他跡象,特別是其中的肝轉移,如果是這樣,那麼我們還可以開始的點,我們還可以開始這個跡象,特別是其中的肝轉移,如果是這樣,那麼我們還可以考慮這個跡象,特別是其中的肝轉移,如果是這樣,那麼我們還可以開始的點,我們還可以開始這個跡象,特別是其中的肝轉移,如果是這樣,那麼我們還可以考慮這個跡象?

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Yeah, no, centers in Europe have done breast cancer. They've done quite a bit of ICC. We've had centers say they'd like to do percutaneous melanoma, but these are like N equals 236, not enough to generate real world data. The most data that's out there on the product is.

    是的,歐洲的中心已經治療過乳癌了。他們已經完成了相當多的 ICC。有些中心表示他們願意進行經皮黑色素瘤治療,但這些就像 N 等於 236,不足以產生真實世界的數據。關於該產品的最多數據是。

  • Uveal Melanoma and docs like to, I want to call it an experiment, TRY this for some patients, what we really drive is either funding an IIT when the doc raises their hands and ask about it and getting that published or sponsored trial, but you know we try, we're trying to get these docs to publish case studies or small series when they have the data.

    葡萄膜黑色素瘤和醫生喜歡,我想稱之為一個實驗,對一些病人嘗試一下,我們真正推動的是當醫生舉手詢問時資助 IIT 並讓它發表或贊助試驗,但你知道我們會嘗試,我們試圖讓這些醫生在有數據時發表案例研究或小系列研究。

  • And hopefully we'll get some more papers out of Europe based on these small and you know retrospective analysis. But I don't think from a revenue perspective, I don't think there's anything that to make into a model that's meaningful.

    希望我們能根據這些小型回顧性分析從歐洲獲得更多的論文。但從收入角度來看,我認為沒有任何事物可以成為有意義的模式。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thank you very much, Gerard, and good luck. Right.

    非常感謝,傑拉德,祝你好運。正確的。

  • Operator

    Operator

  • Our next question comes from Marie Thibault of BTIG. Please go ahead.

    下一個問題來自 BTIG 的 Marie Thibault。請繼續。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Hi, good morning, thanks for taking the questions, Gerard and Sandra and congrats on a very impressive start to the year. Wanted to ask you very quickly, I heard mention of the patient access program. I want to understand if there's been any hurdles in terms of payments or anything that you're seeing on the patient access front that's led to the creation of this program or if this was always sort of intended and and planned as as we typically might see with some of these.

    大家早安,感謝 Gerard 和 Sandra 回答問題,祝賀你們今年取得了令人印象深刻的開端。想快速問您一下,我聽說過有關患者訪問計劃的問題。我想了解在付款方面是否存在任何障礙,或者您在患者訪問方面看到的任何障礙,從而導致了該計劃的創建,或者這是否一直是有意和計劃的,就像我們通常會看到的那樣。

  • More rare diseases, so any detail on that and any impacts you might see, or expect from it, on adoption, pace would be great.

    更多罕見疾病,因此有關這方面的任何細節以及您可能看到或預期的任何影響,對採用、速度都會很棒。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Now in terms of, I mean, we put this in place primarily for co-pays, copay assistance and the rare patient that had no coverage whatsoever. In terms of the hospitals getting reimbursed aside from the HEPZATO that were driven by submitting claims incorrectly. We have seen nothing that gives us any pause about either commercial or Medicare coverage.

    現在就此而言,我的意思是,我們實施這項措施主要是為了共同支付、共同支付援助以及那些根本沒有保險的罕見病人。就除 HEPZATO 之外的醫院因錯誤提交索賠而獲得報銷而言。我們沒有看到任何讓我們對商業或醫療保險覆蓋範圍產生任何疑慮的事情。

  • So, I think this is the sort of thing that it's helpful for patients that can lower their co-pay. If they don't have any coverage at all, we can point them towards various charities that do assist with the patients with rare diseases.

    所以,我認為這對患者有幫助,可以降低他們的共同支付費用。如果他們根本沒有任何保險,我們可以向他們推薦各種為罕見疾病患者提供幫助的慈善機構。

  • And I think as you said, Marie, it is kind of standard practice to have this type of service up and running, if we had been accompanied with, more resources moving into the launch, we probably would have had it on day one, but we had to wait a bit so we could, gather the resources necessary to launch it.

    我認為正如你所說,瑪麗,啟動和運行這種類型的服務是一種標準做法,如果我們在啟動時投入更多的資源,我們可能在第一天就能完成,但我們必須等待一段時間,這樣我們才能收集啟動它所需的資源。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Okay, glad to see it and glad to confirm that billing is going well, and then you know we're expecting Chopin data I think later this year. Any chance we could start to sort of understand what what the bar for what will be impressive to clinicians is? I don't know if you can start to help us set up some expectations for that data at this point.

    好的,很高興看到它,並很高興確認計費進展順利,然後你知道我們期待今年晚些時候獲得蕭邦的數據。我們是否有機會開始了解給臨床醫生留下深刻印象的標準是什麼?我不知道您是否可以開始幫助我們為這些數據設定一些期望。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Yeah, the end point is PFS, so I think you know a meaningful increase in PFS would, is what we're looking for. What might that be? I think it's in the eye of the beholder. I think anything, any increase of, given how severe this disease is for patients.

    是的,終點是 PFS,所以我認為 PFS 的顯著增加正是我們所追求的。那會是什麼?我認為這取決於旁觀者的看法。考慮到這種疾病對患者的嚴重程度,我認為任何情況,任何增加都是可以的。

  • I think for example a four-month increase would be phenomenal, because that's probably translates into four months or more life. So, something in that range, I think would be great. But we'll have to see, but that's my kind of personal bar about four months increasing that would be great.

    我認為例如四個月的增長將是驚人的,因為這可能意味著四個月或更長的壽命。所以,我認為在這個範圍內的東西會很棒。但我們還得拭目以待,但這是我個人的標準,增加四個月就好了。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Okay, great, congrats again on the ninth quarter.

    好的,太好了,再次恭喜第九節。

  • Operator

    Operator

  • Thank you. The next question comes from Sudan Loganathan of Stephens Inc. Please go ahead.

    謝謝。下一個問題來自 Stephens Inc. 的蘇丹·洛加納坦 (Sudan Loganathan)。請提問。

  • Sudan Loganathan - Analyst

    Sudan Loganathan - Analyst

  • Hi, Gerard and Sandra. Congrats on the great quarter and thank you for taking my questions. My first one is going to be kind of on the territories that you mentioned, the six territories you mentioned cover the lower 48 states and get you to that eventual peak site activation to potentially. 40 sites like you've mentioned before, does your current boots on the ground get you to the over 30 sites, or will there need to be some kind of increase to that, SG&A effort, to support site activation growth over 30 sites.

    你好,傑拉德和桑德拉。恭喜本季取得的優異成績,感謝您回答我的問題。我的第一個問題將是關於您提到的地區,您提到的六個地區涵蓋了美國本土 48 個州,並最終使您的站點激活達到峰值。就像您之前提到的 40 個站點,您目前的實地部署是否可以讓您達到 30 多個站點,或者是否需要增加銷售、一般和行政管理費用 (SG&A) 來支援 30 多個站點的站點啟動成長。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • I think we can get to 40 with the six territories. With that said, if it looks like, the number of boots on the ground, as some say is limiting the growth, we'll do more. Luckily this is not a huge expense, we could go from if we went from six territories to eight, that would be an incremental six people, so it doesn't move the needle very much one way or another.

    我認為我們可以在六個地區達到 40 個。話雖如此,如果看起來,實地部隊的數量(正如一些人所說)限制了增長,我們就會採取更多行動。幸運的是,這並不是一筆巨大的開支,如果我們從六個地區擴展到八個地區,那就會增加六個人,所以無論如何,這都不會對情況產生太大的影響。

  • So, time will tell and right now on paper our models say hey we should be able to get by with these 6 territories.

    所以,時間會證明一切,現在從紙上看,我們的模型顯示我們應該能夠解決這 6 個地區的問題。

  • Sudan Loganathan - Analyst

    Sudan Loganathan - Analyst

  • Okay, great. And then my second one, with the FDA clearance now in hand for the phase two trials for, HER2-negative breast cancer and DRC, what are the remaining tasks prior to initiating the first patient on trial, and what's kind of the bars now from initiating a patient, maybe this quarter itself versus, waiting into the third or fourth quarter of this year.

    好的,太好了。然後我的第二個問題是,現在 FDA 已經批准了 HER2 陰性乳癌和 DRC 的二期試驗,在開始對第一位患者進行試驗之前還剩下哪些任務,現在對開始對患者進行試驗的障礙是什麼,可能是在本季度進行,還是等到今年第三季或第四季。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • So, I've got Voyo virtually here with me, so our CMO may ask Voyo to chime in there.

    因此,我實際上已經將 Voyo 帶到了我身邊,因此我們的 CMO 可能會要求 Voyo 加入進來。

  • Vojislav Vukovic - Chief Medical Officer

    Vojislav Vukovic - Chief Medical Officer

  • Sure, happy to address the question. So once the FDA clears the protocol here in the US, we engage with conical trial sites, the major centers, to, review and approve the protocol. Change the site if necessary, and also do the contracting to make sure that the cost of the trial and the procedures is covered.

    當然,很高興回答這個問題。因此,一旦 FDA 在美國批准該方案,我們就會與錐形試驗站點(主要中心)合作,審查並批准該方案。如果有必要的話,更改地點,並簽訂合約以確保試驗和程序的費用得到覆蓋。

  • So, because we typically go to large academic centers which quite complex to navigate. This process can take anywhere between six and 12 months for the typical treatment centers. So that's why there's a GAAP between the FDA clearing the protocol and us actually enrolling patients.

    因此,因為我們通常會去大型學術中心,所以導航相當複雜。對於典型的治療中心來說,這個過程可能需要 6 到 12 個月的時間。這就是為什麼 FDA 批准協議和我們實際招募患者之間存在 GAAP。

  • In Europe it's a similar situation. We filed typically in Europe protocols for regulatory clearance after the FDA has left them, and that's what we've done for these two trials.

    歐洲的情況也類似。我們通常在 FDA 批准後才向歐洲提交方案以獲得監管部門的批准,而這兩項試驗我們就是這樣做的。

  • And in parallel we engage in sites and doing the same process. Activation of sites in Europe can also take anywhere between three and 12 months depending on what type of site in which country it is. So, there's always an operational lag between clearance of the protocol and staff official involvement.

    同時,我們也參與網站建置並執行相同的流程。歐洲網站的啟動也可能需要 3 到 12 個月的時間,具體取決於網站所在的國家/地區的類型。因此,在協議審批和工作人員正式參與之間總是存在操作滯後。

  • I hope that's just your question.

    我希望這只是你的問題。

  • Sudan Loganathan - Analyst

    Sudan Loganathan - Analyst

  • Yeah, thank you for the clarity there. That's true. I really appreciate it. And one more last one if I can squeeze one in, and I think I believe you may have noted before that achieving that around $13 million in revenues should kind of yield like a break-even EPS and then over that could yield a positive EPS, with current off levels, which we now proven in the first quarter. So, congrats on that great milestone.

    是的,謝謝你的澄清。這是真的。我真的很感激。如果可以的話,我還有最後一個問題,我想您可能之前已經註意到,實現約 1,300 萬美元的收入應該會產生盈虧平衡的每股收益,然後超過這個數字可能會產生正的每股收益,目前的水平,我們現在已經在第一季度證明了這一點。所以,恭喜你取得這偉大的里程碑。

  • Now that is proven about your business and with the cash positions you currently have, is there any interest in employing back cash to in license a companion diagnostic device, or therapeutic that go hand in hand with it? Is that okay to be accretive to the business maybe in a shorter time frame than running, clinical trials for label expansion and going that route. Just curious, what your level of consideration is, for that kind of a strategy.

    現在已經證明了您的業務以及您目前擁有的現金狀況,是否有興趣使用返還的現金來獲得伴隨診斷設備或與之相輔相成的治療方法的許可?與運行、進行標籤擴展臨床試驗和走這條路線相比,這是否可以在更短的時間內增加業務?只是好奇,對於這種策略,您的考慮程度如何。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • We always keep an open mind, and a number of things have come across. Our desks to look at, none of which seem like it makes sense. I think you know usually you know in licensing it's usually along the lines of what else could the sales force sell in this type of business.

    我們始終保持開放的心態,也遇到很多事情。看看我們的辦公桌,似乎都沒有意義。我認為,通常你知道,在許可方面,它通常與銷售人員在這種類型的業務中還能銷售什麼有關。

  • I think taking our eye off this very profitable product to sell something that is high volume, low margin that takes a lot more sites to sell into doesn't make a lot of sense. Now something comes along that is more a profile in terms of focus.

    我認為,將我們的注意力從這個非常有利可圖的產品上移開,而去銷售銷量大、利潤低、需要更多網站才能銷售的產品,這是沒有意義的。現在出現了一些在焦點方面更具代表性的東西。

  • Focused highly technical sale that might make some sense but nothing's come across to date in terms of a companion, diagnostic or something, if we do move into an adjuvant setting, which is probably, something we do talk about, but it's not actionable yet, if there was something that for example.

    專注於高度技術性的銷售可能有些道理,但迄今為止在伴隨、診斷或其他方面還沒有任何進展,如果我們確實進入輔助治療領域,這可能是我們確實談論過的事情,但目前還不可行,例如,如果有的話。

  • Predicted one will get liver met we might be interested in funding something like that. I don't, there's no such thing out there right now that's just to pick up its commercialized. That would be more of an R&D investment, but you know we look at complimentary things like that there might be a synergistic systemic, something that for some reason.

    預計其中一人將獲得肝臟治療,我們可能有興趣資助這樣的計畫。我不認為,現在還不存在這樣一種只是為了將其商業化的東西。這更像是一項研發投資,但你知道,我們關注的是互補的東西,例如可能存在協同系統的東西,出於某種原因。

  • Fits with our liver targeted, we would look at that if there's a good clinical and medical rationale, but I don't think there's a lot out there in the near term that fits well within the business. We're certainly not going to license something just to have a larger top line.

    符合我們的肝臟目標,如果有良好的臨床和醫學原理,我們會考慮這一點,但我認為短期內沒有太多適合該業務的產品。我們絕對不會只為了獲得更大的收入而去授權某些產品。

  • Sudan Loganathan - Analyst

    Sudan Loganathan - Analyst

  • Got you. Thanks, Gerard. I really appreciate all the color there and again, great congrats on the great start to the year.

    明白了。謝謝,傑拉德。我真的很欣賞那裡的所有色彩,並再次祝賀今年的美好開端。

  • Operator

    Operator

  • My next question comes from Bill Morgan of Claritev. Please go ahead.

    我的下一個問題來自 Claritev 的 Bill Morgan。請繼續。

  • Bill Morgan - Analyst

    Bill Morgan - Analyst

  • Hi, thanks for taking the question. Congrats on the quarter. So looking at, revenue in Q1, I just kind of want to look at it from any angle to see kind of how stable this base is going forward, with it, being such a strong number. So, was there any month to month variability that might suggest any, quarter to quarter variability going forward, and were there any headwinds, from beginning of the year insurance resets? Thanks.

    你好,謝謝你回答這個問題。恭喜本季取得佳績。因此,從第一季的收入來看,我只是想從任何角度來看一下,這個基礎在未來有多穩定,數字如此強勁。那麼,是否存在月與月之間的差異,這可能預示著未來季度與季度之間的差異,並且從年初保險重置開始是否存在任何阻力?謝謝。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • To the latter part, we expected to perhaps see something with, the copays resetting and we did, we didn't expect, we wondered, that's probably a better way to put it. But with the disease such as this, it seems relatively. I would say immune to it, but it is less of an effect.

    對於後者,我們預計可能會看到一些與共同支付重置有關的事情,我們確實看到了,我們沒有想到,我們想知道,這可能是更好的說法。但對於這種疾病來說,情況似乎相對如此。我想說的是,它對人體有免疫力,但影響較小。

  • In terms of kind of month-to-month variability, we're still talking about relatively small ends, so by definition you're going to have some level of variability. It's tough to tease out a pattern since patients are treated every six to eight weeks and probably closer to eight, we do kind of see an up and down effect. Month to month depending on you know if January has a lot and February has a lot a bit fewer than March is likely to have a lot in April a bit fewer just due to the returning patterns, but it's not that meaningful and again the. The ends are relatively small, so there's noise in there as well.

    就每月變化而言,我們談論的仍然是相對較小的變化,因此根據定義,您將會有一定程度的變化。很難找出一種模式,因為患者每六到八週接受一次治療,可能接近八週,我們確實看到了一種起伏效應。逐月來看,你知道一月是否有很多,二月是否有很多,三月是否少一點,四月是否有很多,少一點,只是由於回歸模式,但這並不是那麼有意義,而且。末端相對較小,因此也會有雜訊。

  • Operator

    Operator

  • Thank you. Ladies and gentlemen, just a reminder, if I ask a question, you won't press star and then one. Our next question comes from Yale Jen of Laidlaw and company Please go ahead.

    謝謝。女士們,先生們,提醒一下,如果我問一個問題,你就不會先按星號,然後再按一號。我們的下一個問題來自 Laidlaw 和公司的 Yale Jen,請繼續。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Good morning, Gerard, and the congrats on a recorder.

    早安,傑拉德,恭喜你獲得錄音機。

  • I have a few short short questions here. First, in terms of the CRC trials, how many sites you are anticipating to activate for the study?

    我這裡有幾個簡短的問題。首先,就 CRC 試驗而言,您預計將啟動多少個網站進行研究?

  • The boy?

    男孩?

  • Vojislav Vukovic - Chief Medical Officer

    Vojislav Vukovic - Chief Medical Officer

  • Sure, we anticipate more than 20 sites across the US and Europe, to participate in the coal trial.

    當然,我們預計美國和歐洲將有 20 多個地點參與煤炭試驗。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great. And the second one is that in I don't remember whether you haven't mentioned that how many units been sold in the quarter, I guess we can calculate that, but would you be able to just provide a number as well?

    好的,太好了。第二個問題是,我不記得您是否提到本季度售出了多少台,我想我們可以計算一下,但您能否也提供一個數字?

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • That we had a price increase, mid first quarter, so it probably isn't quite as clear as that, but I think if you just, divide by about say 185,000 you'll get the number or close to it within, two units or so.

    我們在第一季中期提高了價格,所以可能不是那麼明顯,但我認為如果你除以大約 185,000,你就會得到這個數字,或者接近這個數字,在兩個單位左右。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, so, could you elaborate the level of price increase?

    好的,那麼,您能詳細說明一下價格上漲的幅度嗎?

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Sandra, will you Yeah, the price increases the timing.

    桑德拉,你願意嗎?價格上漲的時機已經到來。

  • Sandra Pennell - Senior Vice President - Finance, Chief Accounting Officer, Executive Officer

    Sandra Pennell - Senior Vice President - Finance, Chief Accounting Officer, Executive Officer

  • Yes, we started the year on January 1, at the price of 182.5, and on February 1, we went up to 187.5.

    是的,我們在 1 月 1 日以 182.5 的價格開始了新的一年,而在 2 月 1 日,我們漲到了 187.5。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great. That's very helpful and thanks. The next question is that in terms of, have you guys start to try to see how many patients, the breakdown of patients that actually refer, initially referred by oncologist versus those patients already in the interventional oncology, so to track in terms of the performance of the sales team toward the colleges.

    好的,太好了。這非常有幫助,謝謝。下一個問題是,你們是否已經開始嘗試了解有多少患者,實際轉診的患者(最初由腫瘤科醫生轉診的患者與已經在介入腫瘤科的患者)的細分情況,以便跟踪銷售團隊對大學的表現。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • So are you Are you asking out of the, how many of those patients were already at that center versus referred into that center. Yes. Oh Kevin, can you give an estimate on that?

    那麼,您是想問,有多少患者已經在該中心,有多少患者被轉診到該中心。是的。哦,凱文,你能對此做出估計嗎?

  • Kevin Muir - General Manager, Interventional Oncology

    Kevin Muir - General Manager, Interventional Oncology

  • Yeah, that's a great question and something we attempt to track some of our key indicators for the health of these centers that we're in, and I would say that right now it's probably around 30% to 40% of the patients are organic to the sites that we have opened with the remainder being referred from the outside.

    是的,這是一個很好的問題,我們試圖追蹤一些關鍵指標來了解我們所在中心的健康狀況,我想說,目前大約有 30% 到 40% 的患者是我們開設的站點的自然患者,其餘患者則是從外部轉診過來的。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great that so that that's actually go ahead, sorry.

    好的,太好了,這樣就可以繼續了,抱歉。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • Yeah, I'm going to say. What's kind of there's Two contravening courses there, we try to get better at generating referrals into the centers. On the flip side is that as more centers open there's less need for referrals, so. But that's a healthy and that the reason we structured these territories with three different types of professionals, the deliver therapy. Manager, the clinical support or specialist.

    是的,我會這麼說。那裡有兩種相矛盾的課程,我們試圖更好地為中心提供推薦。另一方面,隨著更多中心的開放,對轉診的需求越來越少。但這是健康的,這就是我們在這些領域中安排三種不同類型的專業人員來提供治療的原因。經理、臨床支援或專家。

  • Who's in there and then the oncology manager. That third person, their job is to get those referrals to the centers and so they're clearly doing a decent job. Now some of these patients are self-referrals, but definitely, we're doing the introductions for many of these patients, oncologist, to keep feeding the pipeline into these centers.

    誰在那裡,然後是腫瘤科經理。第三個人的工作是將這些轉介送到中心,因此他們顯然做得很好。現在,其中一些患者是自我推薦的,但毫無疑問,我們正在為許多患者介紹腫瘤學家,以便繼續向這些中心提供管道。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great. Maybe the last question here is that I'm just doing a quick scan in terms of the top line, particularly Haado in the United States, and I just realized that you got roughly a $4 million. Quarter over quarter revenue increase up to this quarter, so it's about almost five quarters when we started. I mean, was there any meaning you can Extract from this or simply that just what has happened and thing.

    好的,太好了。也許這裡的最後一個問題是,我只是對頂線進行了快速掃描,特別是美國的 Haado,我剛剛意識到你獲得了大約 400 萬美元。截至本季度,收入逐季增加,因此與我們剛開始時相比,這已經是五個季度了。我的意思是,你能從中提取出什麼意義嗎?或僅僅提取出了發生了什麼事情。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • I think it's driven by center activation, and it hasn't been the same number of centers every quarter, but it's that's roughly what's causing that increase. We had Let's call it, Q3 to $0.05 a quarter three that you're going to end up at the at the pace at which Centers do treatment to kind of leads to that fixed increase every quarter. So, it's not an exponential growth like you might get with a drug, but we'll keep this is kind of more of a typical device cramp, as you enter more centers, you get the growth.

    我認為這是由中心激活所驅動的,並且每個季度的中心數量並不相同,但這大致就是導致這種增長的原因。我們稱之為 Q3,即每季 0.05 美元,最終將以中心進行治療的速度實現每季固定的成長。因此,它並不像藥物那樣呈指數級增長,但我們會認為這是一種更典型的設備痙攣,隨著你進入更多的中心,你就會獲得增長。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • And actually, let me see the last one here which is you may or may not answer which is that can we extrapolate at least for toward the end of this year.

    實際上,讓我看看這裡的最後一個問題,您可能會回答也可能不會回答,那就是我們是否可以推斷至少到今年年底。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • I'll pass on that one, Yale.

    我會傳遞這個,耶魯。

  • Yale Jen - Analyst

    Yale Jen - Analyst

  • Okay, great, thanks a lot and congrats, really congrats on the performance.

    好的,太好了,非常感謝,恭喜,真的恭喜你的表現。

  • Vojislav Vukovic - Chief Medical Officer

    Vojislav Vukovic - Chief Medical Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Ladies and gentlemen, that brings us to the end of today's event. Thank you for attending and you may not disconnect your lines.

    女士們、先生們,今天的活動到此結束。感謝您的參與,您不能斷開線路。

  • Gerard Michel - Chief Executive Officer, Director

    Gerard Michel - Chief Executive Officer, Director

  • All right, who's still here?

    好吧,誰還在這兒?