Delcath Systems Inc (DCTH) 2026 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Delcath Systems first quarter 2026 earnings conference call. (Operator Instructions) This call is being recorded on Thursday, May 7, 2026.

各位女士、先生，早安，歡迎參加 Delcath Systems 2026 年第一季財報電話會議。(接線員指示) 本次電話會議將於 2026 年 5 月 7 日（星期四）錄音。

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

現在我想把會議交給 David Hoffman。請開始。

Thank you, and welcome to Delcath Systems first quarter 2026 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Chief Financial Officer; Kevin Muir, Chief Commercial Officer; Vojislav Vukovic, Chief Medical Officer; and Martha Rook, Chief Operating Officer.

謝謝，歡迎參加 Delcath Systems 2026 年第一季財報電話會議。與我一同出席的有：執行長 Gerard Michel；財務長 Sandra Pennell；商務長 Kevin Muir；醫務長 Vojislav Vukovic；以及營運長 Martha Rook。

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.

本聲明係依據《1995 年私人證券訴訟改革法》所述之前瞻性陳述安全港條款作出。除歷史事實外，本次電話會議中所作之所有陳述，均可能構成《1933 年證券法》第 27A 條及《1934 年證券交易法》第 21E 條所定義之前瞻性陳述。

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

儘管本公司認為這些前瞻性陳述所反映之預期與假設屬合理，但本公司不保證該等預期將被證實為正確。由於各種風險與不確定性，實際結果可能與前瞻性陳述中明示或暗示之內容存在重大差異。

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 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. 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.

關於可能導致實際結果與前瞻性陳述中明示或暗示之結果不同的相關風險與不確定性之討論，請參閱本公司 Form 10-K 年度報告中所詳述之風險因素、已提交之 Form 10-Q 季度報告所載內容，以及本公司不時向美國證券交易委員會提交的其他報告。本次電話會議所包含之任何前瞻性陳述僅以本次電話會議日期為準。本公司不承擔任何義務更新或補充任何前瞻性陳述，以反映其後取得之資訊、事件或情況。

Our press release with our first quarter 2026 results is available on our website 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.

我們發布的 2026 年第一季業績新聞稿可於本公司網站「投資人」專區取得，並包含更多關於我們財務結果的細節。我們的網站亦提供最新的 SEC 申報文件，建議各位查閱。今日電話會議的錄音將於本公司網站提供。

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

現在我想把電話會議交給 Gerard。Gerard，請繼續。

Thank you, David, and welcome, everyone. We've had a very successful first quarter marked by four-centre activations and record new patient starts in the first quarter, both of which are core growth drivers for the business. In addition, we continue to advance numerous commercial and medical initiatives to ensure the long-term growth of HEPZATO with a strong focus on a third critical growth driver, building referral networks to quickly connect eligible patients with treating centers. To support center activations, increased utilization at existing centers and expanded referral patterns, we have nearly completed our US commercial expansion into nine regions.

謝謝你，David，也歡迎各位。我們第一季表現非常成功，亮點包括啟用四個中心，以及第一季新病患開始治療人數創下紀錄；這兩項都是公司業務的核心成長驅動因素。此外，我們持續推進多項商業與醫療計畫，以確保 HEPZATO 的長期成長，並高度聚焦第三個關鍵成長驅動因素：建立轉介網絡，快速將符合資格的病患連結至治療中心。為了支持中心啟用、提升既有中心的使用率並擴大轉介模式，我們幾乎已完成美國商業版圖擴張至九個區域。

In addition, the expanded MSL team is fully trained and in the field, educating physicians about metastatic uveal melanoma with a focus on the CHOPIN results.

此外，擴編後的 MSL 團隊已完成全面訓練並已在第一線，向醫師宣導轉移性葡萄膜黑色素瘤，並聚焦於 CHOPIN 的研究結果。

As of today, we have 29 REMS-certified sites, and we are in active discussions with over 50 potential new centers. And 38 of these centers have had one or more members of a potential treatment team take the time to travel and be preceptive. While not all of these centers will be activated and the practice can take over a year in some cases, there is clearly broad-based interest in this therapy, which bodes well for the long-term growth of the business.

截至今日，我們已有 29 個通過 REMS 認證的據點，並正與超過 50 個潛在新中心積極洽談。其中有 38 個中心已有一位或多位潛在治療團隊成員願意花時間出行並進行見習（preceptorship）。雖然並非所有中心都會啟用，且在某些情況下流程可能需要一年以上，但顯然市場對此療法具有廣泛興趣，這對公司長期成長是正面訊號。

As we note on every call, it is very difficult to predict pacing. And given where we are at this point in the year, we are modifying our year-end activated center build to 37 active centers with 40 active center treatment centers sometime in the first quarter of 2027.

如同我們每次電話會議所提到的，進度節奏非常難以預測。鑑於我們目前在年度中的進展，我們將年末啟用中心的目標調整為 37 個運作中中心，並預期於 2027 年第一季某個時間點達到 40 個運作中的治療中心。

In patient center activation, we are focused on changing prescribing patterns by expanding the set of appropriate patients that treating teams consider for PHP through education, fostering peer-to-peer conversations and evidence generation. First quarter 2026 new patient starts per site have tracked at or slightly higher than the first quarter of 2025 at approximately 0.7 new patients per site per month. New patient starts contribute to revenue over subsequent quarters as patients receive a series of treatments. We expect the strong first quarter new patient starts to offset the reduced site activation pace.

在病患與中心啟用方面，我們聚焦於透過教育、促進同儕間交流以及產生更多證據，來改變處方模式，擴大治療團隊在考量 PHP 時所認定的適用病患範圍。2026 年第一季各據點的新病患開始治療數，約為每據點每月 0.7 位，與 2025 年第一季持平或略高。新病患開始治療會在後續季度隨著病患接受一系列療程而貢獻營收。我們預期第一季強勁的新病患開始治療數，將可抵消據點啟用速度放緩的影響。

Based on conversations with some treating physicians, we know that the publication of the CHOPIN results in Lancet Oncology is already changing treatment patterns at certain centers. One piece of publicly available anecdotal evidence is the recent webinar hosted by the patient advocacy group at Kurinsight, during which Dr. Sid Padia, an interventional radiologist from UCLA, shared his experience treating metastatic uveal melanoma patients with HEPZATO. Some of the patients Dr. Padia is treating with PHP are also being treated with immunotherapy.

根據與部分治療醫師的對話，我們得知 CHOPIN 結果發表於《Lancet Oncology》後，已在某些中心改變治療模式。一項公開可得的軼事證據是病患倡議團體 Kurinsight 近期主辦的線上研討會，會中 UCLA 的介入放射科醫師 Sid Padia 醫師分享了他以 HEPZATO 治療轉移性葡萄膜黑色素瘤病患的經驗。Padia 醫師以 PHP 治療的部分病患，同時也接受免疫治療。

And he noted on the webinar that his results with these patients are consistent with or perhaps superior in the positive results reported from the CHOPIN trial. As a reminder, CHOPIN response rates improved from approximately 40% with HEPZATO alone to about 76% when HEPZATO was combined with immunotherapy, including some cases of complete response. The combination arm demonstrated a survival benefit with a clear separation between survival curves of both one and two years.

他在研討會中指出，他在這些病患身上觀察到的結果，與 CHOPIN 試驗所報告的正向結果一致，甚至可能更佳。提醒各位，CHOPIN 的反應率在僅使用 HEPZATO 時約為 40%，而當 HEPZATO 與免疫治療合併使用時提升至約 76%，其中包含部分完全緩解案例。合併治療組顯示存活獲益，在一年與兩年的存活曲線之間均呈現明顯分離。

Dr. Padia characterized these study results as extremely encouraging and consistent with his clinical experience. Many metastatic uveal melanoma patients are managed outside REMS-certified centers. So earlier identification and streamlined referral processes are essential. One important approach to enhancing referral patterns is to use multiple data sources to identify physicians treating newly diagnosed metastatic patients and promptly connect these patients with a suitable HEPZATO treatment center.

Padia 醫師將這些研究結果形容為極具鼓舞，且與他的臨床經驗一致。許多轉移性葡萄膜黑色素瘤病患是在 REMS 認證中心之外接受管理。因此，更早的辨識以及更順暢的轉介流程至關重要。強化轉介模式的一項重要作法，是運用多種資料來源辨識正在治療新診斷轉移病患的醫師，並迅速將這些病患連結至合適的 HEPZATO 治療中心。

As these networks mature, we expect referrals to be an important driver of new patient starts across our footprint. I now would like to turn to our clinical development programs. In our ongoing metastatic colorectal cancer trial, we continue to activate new trial sites and now have a total of 13 centers who can actively screen CRC patients. We have implemented specialized training modules and streamlined onboarding processes to continue to accelerate site readiness and ensure protocol adherence. We are on track to activate nearly all of the currently targeted 26 trial sites by the end of this year and anticipate presenting interim results in late 2027.

隨著這些網絡逐步成熟，我們預期轉介將成為我們整體布局中新病患開始治療的重要驅動因素。接下來我想談談我們的臨床開發計畫。在進行中的轉移性大腸直腸癌試驗中，我們持續啟用新的試驗據點，目前共有 13 個中心可主動篩選 CRC 病患。我們已導入專門訓練模組並簡化上線流程，以持續加速據點就緒並確保遵循試驗方案。我們按計畫將在今年年底前啟用目前目標的 26 個試驗據點中的幾乎全部，並預期於 2027 年下半年公布期中結果。

To date, we have enrolled seven patients. While this pace has been slower than initially anticipated, we believe the program is picking up momentum.

截至目前，我們已招募七名患者。雖然這一進度較最初預期為慢，但我們相信該計畫正逐步累積動能。

Our second program in metastatic breast cancer now has 4 clinical trial sites that are prepared to screen patients with additional sites opening soon. Since breast cancer physicians typically have less experience with liver-directed therapies compared to those treating metastatic colorectal cancer, we are conducting targeted education and outreach initiatives to increase awareness of HEPZATO's potential benefit to patients with metastatic breast cancer. We are targeting 15 trial sites and expect to activate them by late 2026. We will provide guidance related to the readouts from this trial later this year as operational progress supports more precise forecasting.

我們在轉移性乳癌的第二項計畫目前已有 4 個臨床試驗中心已準備好篩選患者，且不久將有更多中心啟用。由於乳癌醫師相較於治療轉移性大腸直腸癌的醫師，通常對肝臟定向治療的經驗較少，我們正進行針對性的教育與外展推廣，以提升對 HEPZATO 可能為轉移性乳癌患者帶來效益的認知。我們的目標是 15 個試驗中心，並預期於 2026 年底前完成啟用。隨著營運進展支持更精準的預測，我們將於今年稍晚提供與本試驗讀出相關的指引。

We are seeing growing interest in HEPZATO beyond colorectal and breast cancer and are exploring clinical trial designs into additional indications, guided by physician input and advisory board feedback. Based on the results of the CHOPIN trial, there is strong enthusiasm from the medical community to investigate a CHOPIN-like combination regimen to treat liver involvement in patients with a variety of solid tumor types. I look forward to sharing updates on these plans later in the year.

我們看到 HEPZATO 在大腸直腸癌與乳癌之外的興趣日益增加，並在醫師意見與顧問委員會回饋的指引下，探索擴展至其他適應症的臨床試驗設計。根據 CHOPIN 試驗結果，醫學界對於研究類似 CHOPIN 的聯合療法方案、用以治療多種實體腫瘤類型患者的肝臟受累，抱持高度熱忱。我期待在今年稍晚分享這些計畫的最新進展。

I will now ask Sandra to review our financial results.

接下來我將請 Sandra 回顧我們的財務結果。

Thank you, Gerard. Total revenue in the first quarter of 2026 was $25 million compared with $19.8 million in the first quarter of 2025. This included $23.3 million of HEPZATO KIT revenue and $1.7 million of CHEMOSAT revenue. Gross margin for the quarter was 85% compared to 86% in the first quarter of 2025. Research and development expenses in the first quarter was $9.8 million compared to $5 million in the prior quarter, driven primarily by continued investment in our clinical organization and the ongoing Phase II trial.

謝謝你，Gerard。2026 年第一季總營收為 2,500 萬美元，較 2025 年第一季的 1,980 萬美元增加。其中包含 2,330 萬美元的 HEPZATO KIT 營收與 170 萬美元的 CHEMOSAT 營收。本季毛利率為 85%，相較於 2025 年第一季的 86%。2026 年第一季研發費用為 980 萬美元，較前一季的 500 萬美元增加，主要係因我們持續投資臨床組織以及進行中的第二期試驗。

Selling, general and administrative expense in the first quarter was $13.1 million compared to $11.3 million in the prior year quarter. This reflects our investment into the continued commercial expansion and increased marketing activities. Net loss for the first quarter was $1.1 million compared to net income of $1.1 million in the prior year first quarter.

2026 年第一季銷售、一般及行政費用為 1,310 萬美元，較去年同期的 1,130 萬美元增加。這反映我們對持續商業擴張及增加行銷活動的投資。第一季淨損為 110 萬美元，相較於去年第一季淨利 110 萬美元。

On a non-GAAP basis, adjusted EBITDA for the quarter was $3.4 million compared to $7.6 million for the first quarter of 2025. We ended the quarter with $89.3 million in cash and investments and no debt. Cash provided by operations was $0.9 million in the quarter. We also purchased approximately 300,000 common shares for about $3 million in the first quarter under the company's approved $25 million share buyback program. To date, we have purchased $9 million worth of common shares.

以非 GAAP 基礎計，當季調整後 EBITDA 為 340 萬美元，較 2025 年第一季的 760 萬美元下降。本季期末我們持有 8,930 萬美元的現金及投資，且無負債。本季營運活動提供的現金為 90 萬美元。我們亦於第一季在公司核准的 2,500 萬美元庫藏股回購計畫下，以約 300 萬美元回購約 30 萬股普通股。截至目前，我們已回購價值 900 萬美元的普通股。

Turning to 2026 guidance. We are confident we will achieve total revenue of at least $100 million, which reflects 20% growth in HEPZATO kit volume over 2025. Our guidance takes into account expected seasonal trends in the third and fourth quarters, much like in 2025 when new patient starts rates declined partially due to scheduling challenges. Forecast for 2026 gross margins remain between 85% to 87%, and we now expect to report positive adjusted EBITDA for the remainder of the year.

接著談 2026 年財測指引。我們有信心達成至少 1 億美元的總營收，這反映 HEPZATO kit 銷量較 2025 年成長 20%。我們的指引已納入第三季與第四季預期的季節性趨勢，類似於 2025 年，當時新患者啟動率部分因排程挑戰而下降。2026 年毛利率預測仍維持在 85% 至 87% 之間，且我們現在預期今年剩餘期間將呈報正向的調整後 EBITDA。

I want to thank you all for participating today. This does conclude our prepared remarks, and I'd ask the operator to open the phone lines for Q&A.

感謝各位今天的參與。以上為我們事先準備的發言內容，並請接線員開放電話線進行問答。

(Operator Instructions)

(接線員指示)

Marie Thibault, BTIG.

Marie Thibault，BTIG。

Good morning, Gerard and Sandra. Thank you for taking the questions. I wanted to ask my first here on the volume you're seeing per site. Certainly encouraging to hear that that's more than offsetting kind of the slightly slower pace of activations. So I just want to understand what was driving that. It sounds like perhaps CHOPIN is having a bit of an effect. I know in the past, competing or other trials might have been a distraction.

早安，Gerard 與 Sandra。謝謝你們回答問題。我想先問一下你們在各試驗中心看到的每站點量能。聽到這足以抵消啟用速度稍慢的影響，確實令人鼓舞。所以我想了解是什麼因素在推動。聽起來或許 CHOPIN 有一些影響。我知道過去競爭性或其他試驗可能會造成分心。

So if you can just tell us a little bit more about some of the dynamics behind driving that higher volume.

所以如果可以的話，請再多談一些推動較高量能背後的動態因素。

Yeah, I think it's primarily CHOPIN as well as new sites come on board. Not all of them, but as some of the new sites come on board, when they see the results, they start increasing their volume. So I think it's both things, what they see in practice and the CHOPIN results as well. Clinical trial headwinds are probably reduced a bit from probably similar time last year.

是的，我認為主要是 CHOPIN，再加上新中心加入。並非所有中心都是如此，但有些新中心加入後，當他們看到結果，就開始提高量能。所以我認為兩者都有影響：他們在臨床實務中看到的情況，以及 CHOPIN 的結果。臨床試驗帶來的逆風，相較於大約去年同期，可能也減輕了一些。

But I think the majority of the effect, as best as I can sort out, is CHOPIN and then doctors just seeing the scans and seeing the tumor shrinkage.

但就我能釐清的情況來看，影響的主要部分是 CHOPIN，以及醫師親眼看到影像掃描並看到腫瘤縮小。

Okay, Great to hear. Simple enough. And then I'll ask a follow-up, I think, for Sandra. When we think about the spending trajectory this year, I recall that it is expected to be higher in 2026 than it was in 2025. Can you just give us any more detail, if you have it at this point, on visibility for cadence of that spending, how you see some of the investments in R&D and commercial expansion unfolding throughout this year?

好的，很高興聽到。很簡單明瞭。接著我想追問一題，應該是給 Sandra。談到今年的支出走勢，我記得 2026 年的支出預期會高於 2025 年。你能否在目前這個時間點提供更多細節，說明對支出節奏的能見度，以及你如何看待今年研發與商業擴張的投資在全年中的展開？

Absolutely. So I know in the previous call, we did mention R&D for full year 2026 would be about a 90% increase over 2025. But based on a little bit of acceleration in the enrollment in both trials, we're likely going to see a full year increase closer to the 70% to 75% over 2025. R&D, we will likely see a decent increase in Q2, about 20% over Q1, and start to level off, but about 10% over the remainder of the year and into the fourth quarter. SG&A, probably about a 60% increase in 2026 over 2025 due to the sales force expansion and just increases in selling costs as we grow.

當然可以。我們在前一次電話會議中提到，2026 全年研發費用約較 2025 年增加 90%。但由於兩項試驗的入組速度略有加快，我們全年增幅可能更接近較 2025 年增加 70% 至 75%。研發方面，我們可能會在第二季看到相當幅度的增加，約較第一季增加 20%，之後開始趨於平穩，但在今年剩餘期間至第四季大約仍會維持較前期高出約 10% 的水準。SG&A 方面，2026 年可能較 2025 年增加約 60%，主要因擴編銷售團隊，以及隨著成長帶來的銷售成本上升。

Q2 for SG&A, probably a 10% to 15% increase over Q1 due to those marketing initiatives and then increase just modestly each quarter thereafter.

SG&A 在第二季可能較第一季增加約 10% 至 15%，主要因那些行銷推廣計畫，之後每一季再小幅增加。

Very helpful. Thank you.

非常有幫助。謝謝。

John Newman, Canaccord.

John Newman，Canaccord。

Congrats on the continued progress. I just wondered if you could talk a little bit about the factors involved regarding the change to the site addition guidance. Obviously, it looks like that's going to be offset by increased patient volume, which is great. But just curious if you could discuss a little bit the different factors that went into that change there.

恭喜持續取得進展。我只是想請您稍微談談，關於站點新增指引變更所涉及的因素。顯然，看起來這將會被增加的病患量所抵銷，這很棒。但我只是好奇，您是否能稍微說明一下，促成這項變更的不同因素有哪些。

Really, the visibility we have in terms of -- there's always about half a dozen or more sites roughly that look like they could go any week. And so the pipeline is full. I want to make sure that's clear. If I don't have patients that I know are scheduled for treatment or multiple patients going through screening, then I'm a little reluctant to say, hey, I'm going to get a couple of sites in the next month or two. The average pace has been a little over — since we've launched has been, I think, about 1.1, 1.2 per month.

其實，就我們在可視性方面而言——大概一直都有半打或更多的站點，看起來任何一週都有可能啟動。所以管線是滿的。我想確保這點很清楚。如果我沒有病患是我知道已排程要治療，或是有多位病患正在進行篩檢，那我會有點不太願意說：嘿，我接下來一兩個月會新增幾個站點。自我們啟動以來的平均速度，我想大約是每月 1.1、1.2 個。

But if I don't see sites ready to treat a patient or having one scheduled, then I say, all right, I'm going to have another dry month or two, and I pull that out. So, under that framework, I'm saying, yes, it's more likely we'll be 37. Could it be 38 or 39? Yes. But I think 37 is probably a more likely number.

但如果我看不到站點已準備好治療病患或已有排程，那我就會說，好吧，接下來可能又會有一兩個月的空窗期，然後我就把那部分往後移。所以，在這個框架下，我的意思是，是的，更可能會是 37 個。會不會是 38 或 39？會。但我認為 37 可能是更有可能的數字。

And it's as simple as that. We just don't see anything in the next month or so, so I kind of reduce it.

就這麼簡單。我們在接下來一個月左右看不到什麼動靜，所以我就稍微下修。

Okay, great. And then one quick follow-up. On the CHOPIN data, which I think are really fantastic and should be really beneficial, I'm curious if you're seeing most of the new sites that you're in discussion with kind of citing that as a factor for their enthusiasm, or if it's sort of balanced between new and old sites. I'm just curious if perhaps you're seeing kind of the new sites pick up on this in terms of wanting to get on board with the product? Or is it kind of balanced across older existing sites and the new sites?

好的，很棒。接著一個快速追問。關於 CHOPIN 數據，我覺得真的非常出色，而且應該會很有幫助。我好奇的是，您是否看到大多數正在洽談的新站點，把這視為他們熱情的一個因素，還是新舊站點之間大致平衡。我只是想了解，是否新站點在想加入產品時，特別會注意到這點？或者在既有的老站點與新站點之間大致是平衡的？

All right. So if you're asking the level of enthusiasm from CHOPIN, I think it's both new and existing. There are some existing sites that have been doing a CHOPIN -like protocol from day one when they became active. And there are others that have moved over to that given the data. I would argue that probably most new sites are planning to do a CHOPIN -like protocol, a combination of immunotherapy and PHP.

好的。所以如果你問的是 CHOPIN 帶來的熱情程度，我認為新站點與既有站點都有。有些既有站點從一開始啟用的第一天起，就一直在做類似 CHOPIN 的方案。也有其他站點在看到數據後轉向採用。我會認為，多數新站點計畫採用類 CHOPIN 的方案，也就是免疫治療與 PHP 的組合。

But Kevin, why don't you chime in? You're a little closer to it than I am in terms of would you say almost all the new sites are going with the CHOPIN? Or is it more 50:50?

不過 Kevin，你要不要補充一下？就你而言，你比我更貼近實際情況；你會說幾乎所有新站點都會採用 CHOPIN 嗎？還是大概 50:50？

I would say that the majority of them will be going with the CHOPIN -like protocol. We hear a lot about just combination treatments in general, but CHOPIN specifically. Now it is kind of important to note the new sites we have been engaged with for months. As you just pointed out, the site opening process takes a considerable amount of time. So when we talk with these sites as they are bringing us on, there are many conversations between peer-to-peer groups as well as our medical and clinical team as well.

我會說其中大多數會採用類 CHOPIN 的方案。我們常聽到大家談到組合治療的一般趨勢，但特別是 CHOPIN。另外也很重要的一點是，我們與這些新站點的接觸已經持續了好幾個月。如你剛才指出的，站點開設流程需要相當長的時間。因此，當我們與這些站點合作、他們把我們納入時，除了同儕對同儕的團體交流外，我們的醫療與臨床團隊之間也有很多對話。

So everyone is well versed in the CHOPIN -type protocol. And so I would anticipate the majority of them that are coming on in the future will embrace that.

所以大家都非常熟悉 CHOPIN 類型的方案。因此我預期，未來加入的大多數站點都會採納那個方案。

Great. Thanks.

很好。謝謝。

Great. Thank you.

很好。謝謝。

Sudan Loganathan, Stephens.

Sudan Loganathan，Stephens。

Hi. Good morning, Gerard and Sandra. My first question is regarding the ESMO breast cancer data that you also provided. I noticed that the adverse event profile showed some Grade three-four adverse events in about 8% of patients. Additionally, the median overall survival is around 6 months for untreated liver metastatic breast cancer patients, or maybe around the four- to five-month range. So just kind of curious on how you're viewing this first set of data for this indication and how this kind of dictates how you go forward?

嗨。早安，Gerard 和 Sandra。我的第一個問題是關於你們也提供的 ESMO 乳癌數據。我注意到不良事件概況顯示，大約 8% 的病患出現了三級到四級的不良事件。此外，未治療的肝轉移乳癌病患的整體存活期中位數大約是 6 個月，或可能在 4 到 5 個月左右。所以我想請教，你們如何看待這個適應症的第一批數據，以及這會如何影響你們接下來的推進方式？

Yeah, these were all very heavily pretreated patients. And I think probably one of the most important parts of the data is -- although the adverse event profile you mentioned may seem high to oncologists, these events are easily managed and all are resolvable. I think there's not much that can be done for these types of patients that were treated. So I think we're quite happy with the data and glad it's there to help improve recruitment, site activation and recruitment in the clinical trial.

是的，這些病患都接受過非常多線的治療。我認為數據中最重要的一點之一是——雖然你提到的不良事件概況對腫瘤科醫師而言可能看起來偏高，但這些事件都容易處理，而且都可恢復。我認為對於這類已接受治療的病患，能做的其實不多。所以我們對這些數據相當滿意，也很高興它能幫助改善臨床試驗的招募、站點啟用與招募。

I'll ask Vojislav, is there any other commentary you want to add regarding those results?

我想問一下 Vojislav，對於這些結果你還有沒有其他想補充的評論？

Yes, sure. So thanks for the question. In addition to the comments that Gerard made, I'd like to point out that the patients who were treated with HEPZATO in this data review received a median of four prior systemic treatments. That means they have been receiving multiple chemotherapies and many, if not most, of the patients have residual toxicities. So these are not the patients that we have treated before in the FOCUS or Phase III trial, which are typically very little pretreatment or no pretreatment at all.

是的，當然。謝謝你的提問。除了 Gerard 的評論之外，我想指出，在這次數據回顧中接受 HEPZATO 治療的病患，先前系統性治療的中位數為 4 線。這表示他們已接受多種化療，而且許多（如果不是大多數）病患仍有殘留毒性。因此，這些並不是我們在 FOCUS 或第三期試驗中治療過的那類病患；那些病患通常幾乎沒有接受過前期治療，或完全沒有。

So the safety profile depends also on the line of treatment in which you administer PHP. And regarding your comment about the survival, these are patients with breast cancer and they develop liver metastases. Typically, that's the final stage of the disease where patients have just a few months of life left. So seeing 6 months is actually, in that context, not so bad. And doctors expressed a great deal of satisfaction when we talk to them about being able to manage this very difficult stage of the disease.

因此，安全性概況也取決於你在第幾線治療中施行 PHP。至於你對存活期的評論，這些是乳癌病患並發展出肝轉移。通常那是疾病的末期階段，病患往往只剩下幾個月的生命。所以在那樣的背景下，看到 6 個月其實不算差。而且當我們與醫師討論能夠處理這個非常困難的疾病階段時，醫師表達了相當高的滿意度。

Thank you. I appreciate the details. And then additionally, I just wanted to ask, even as we go into the second half of this year, could we still anticipate a few other data readouts or just other updates on either breast cancer or colorectal cancer indications going forward?Thanks.

謝謝。我很感謝這些細節。另外我也想問，即使進入今年下半年，我們是否仍可預期會有其他一些數據讀出，或是關於乳癌或大腸直腸癌適應症在後續推進上的其他更新？謝謝。

Yeah, there's not going to be any data readouts. I mean we'll keep you apprised of how the trials are proceeding in terms of open sites and patients. But there won't be any data readouts from us. As you know, the product has been on the market as a stand-alone device in Europe for over a decade.

是的，不會有任何數據讀出。我的意思是，我們會就試驗進展情況向各位通報，例如已開放的中心與患者招募情況。但我們不會發布任何數據讀出。如各位所知，該產品作為獨立設備在歐洲上市已超過十年。

And often data comes out that we don't know investigators or clinicians have submitted for a poster presentation or publication. So could something else come out? Yes, but not from the company.

而且常常會有我們不知道的數據被研究者或臨床醫師提交做海報展示或發表。所以還會有其他結果出來嗎？會的，但不會由公司發布。

Chase Knickerbocker, Craig-Hallum.

Chase Knickerbocker，Craig-Hallum。

Good morning, everyone. This is Jake on for Chase. Just first, regarding the goal of 40 sites by the first quarter of 2027, for the incremental 11 sites, how much are you relying on the three new sales territories? And what are you seeing from the funnel there?

各位早安。我是 Jake，代替 Chase 發言。首先，關於在 2027 年第一季前達到 40 個中心的目標，新增的 11 個中心中，你們有多大程度仰賴三個新的銷售區域？那邊的漏斗（pipeline）情況如何？

Yeah, The territories are not new geographies, okay? So we are just slicing the existing territories from four to six to nine into smaller territories, so there's more concentrated effort. So there's no particular territory. I think the reason to increase -- there's no particular region where we're going to get more business.

是的，這些區域不是新的地理市場，好嗎？我們只是把既有區域從四個切分成六個、再到九個，切成更小的區域，讓投入更集中。所以沒有特定哪個區域。我認為增加（人力/區域）的原因——並不是因為某個特定地區會帶來更多業務。

As sites are opened, it takes effort to manage open sites. So, to maintain the same level of effort in terms of activating the sites and the same pace of activating the sites, we have to put more bodies in the field. Now these are very experienced reps, bodies. But we have to put more experienced people out there to manage the existing accounts and to maintain the same level of site activation effort.

隨著中心開放，管理已開放中心需要投入精力。因此，為了在啟動中心以及維持中心啟動速度方面保持同等投入，我們必須在前線增加人手。而且這些都是非常有經驗的業務代表。但我們必須派出更多有經驗的人員，來管理既有客戶並維持同等強度的中心啟動工作。

Okay. And then on guidance, just on a run rate basis, you're already at the $100 million floor just with this quarter. What are your assumptions for the remaining 3 quarters for revenue?

了解。另外關於財測，以目前的運行率來看，光是這一季你們就已經達到 1 億美元的下限。那你們對接下來 3 個季度的營收假設是什麼？

Yeah, Well the assumptions, as I mentioned before, are that we will see the same seasonal impact we saw in the third and fourth quarter of last year. Now we could be wrong there. In hindsight, it could very well be that we're being overly conservative. But we have a very small end in terms of understanding to what extent seasonality will impact things.

是的，我們的假設，如我先前提到的，是我們會看到與去年第三、第四季相同的季節性影響。當然我們也可能判斷錯。事後回看，很可能我們其實過於保守。但我們對季節性會在多大程度上影響業績的理解仍然非常有限。

There are certain aspects of the seasonality that we think we can address and are trying to address. The specific one that we are trying to handle is if at an important center, there is only one full treatment team, let's say there's only one IR or there's only one anesthesiologist who's trained. If they go on vacation, by definition, the capacity has dropped at that center.

季節性有些面向我們認為可以處理，也正在嘗試處理。我們特別想解決的一點是：如果在某個重要中心只有一個完整治療團隊，例如只有一位介入放射科醫師（IR）或只有一位受訓的麻醉科醫師。如果他們去休假，按定義該中心的產能就會下降。

So, we have implemented a special incentive to the sales force. If you get a second treatment team trained up and going, there will be something in it for the rep. That is yielding some additional backup treatment teams. And I'm hopeful that, that will offset some of the seasonality we saw. There's also seasonality, I think, by patients deciding in certain times of the year, they would rather not be treated.

因此，我們已對銷售團隊推出一項特別激勵措施。如果你能讓第二個治療團隊完成訓練並開始運作，業務代表就會獲得相應獎勵。這正在帶來一些額外的備援治療團隊。我希望這能抵消我們先前看到的部分季節性影響。另外我認為也存在患者端的季節性：患者在一年中的某些時段會選擇不接受治療。

They'll postpone treatment or postpone getting started. That is difficult for us to impact. But for those aspects we can impact, specifically maintaining capacity in terms of training teams, we're doing what we can. But again, getting back to the core of your question, what assumptions are we utilizing given we're already at a run rate to hit guidance, we're assuming we see the same level of seasonality as last year. And again, that might be overly conservative.

他們會延後治療或延後開始。這一點我們很難施加影響。但對於我們能影響的部分，特別是透過訓練團隊來維持產能，我們會盡力而為。不過回到你問題的核心：在我們已經以運行率足以達成指引的情況下，我們採用的假設是季節性程度與去年相同。再次強調，這可能偏保守。

But I think it's best to guide that way and also to be clear about our assumptions underlying the guidance.

但我認為以這種方式給出指引是最好的，同時也清楚說明指引背後的假設。

Appreciate that color. Thank you.

感謝這些補充說明。謝謝。

John Newman.

John Newman。

Hi. Thanks for taking my follow-up. I had a question about the recent data that you were just discussing earlier on the breast cancer work that was done in Europe. It was interesting, I noticed that the median number of cycles was 1. And I'm wondering if you think that's representative of what we'll see going forward when you test this treatment in perhaps a different set of breast cancer patients and also whether that median cycle may have just been limited by either patient survival or just physicians that maybe hadn't had a lot of experience with the treatment. Thanks.

你好。謝謝讓我追問。我想問一下你們剛才提到、近期在歐洲完成的乳癌研究數據。很有意思的是，我注意到治療週期（cycles）的中位數是 1。我想知道你們是否認為，未來在可能不同的一組乳癌患者中測試這項治療時，也會看到類似情況；以及這個中位週期是否可能只是受到患者存活期限制，或是因為醫師對該治療經驗不足所致。謝謝。

Yeah, I will note that the clinical protocol calls for 2 treatments. So I would think that would be the median when the trial reads out. In terms of why they only received one, I have some theories, but let me ask Vojislav to comment.

是的，我要指出臨床試驗方案規定是進行 2 次治療。所以我認為當試驗讀出時，中位數應該會是 2。至於為什麼他們只接受一次，我有一些推測，但我先請 Vojislav 來評論。

Yeah, as Gerard mentioned, this was not a prospective trial. This is basically reflecting data from real-world clinical practice. And the practicing physicians were probably making decisions which they thought in the absence of any guiding data are the best for the patients. So just to remind you, these are heavily pretreated patients with a median of four prior treatments, quite exhausted with lots of residual toxicities.

是的，如 Gerard 所說，這不是一項前瞻性試驗。這基本上反映的是現實世界臨床實務的數據。而臨床醫師在缺乏任何指引性數據的情況下，可能會做出他們認為對患者最好的決策。提醒一下，這些都是重度既往治療的患者，先前治療的中位數為 4 種，身心相當耗竭，且殘留許多毒性反應。

And I think physicians were probably being cautious and trying to manage the disease, perhaps not to achieve the best possible efficacy, but rather to control the disease and prolong patients' lives, which will be typical the treatment goal after first or second line. So I think that the median number of cycles simply reflects the different treatment objective compared to if you treat patients at an earlier stage in the patient journey.

我認為醫師可能較為謹慎，並試圖管理疾病；也許不是追求最佳可能療效，而是控制疾病並延長患者生命——這通常是在第一線或第二線治療之後的典型治療目標。因此，我認為週期數的中位數只是反映了不同的治療目標；若在患者治療旅程較早期的階段進行治療，目標就會不同。

Great. Thank you.

很好。謝謝。

Yale Jen, Needham & Company.

Yale Jen，Needham & Company。

Good morning, and thanks for taking the questions. You refer in the press release that you have 36% volume growth year-over-year of the same quarter. I just wonder whether if you compare to the fourth quarter of last year, what that readout might be? And then I have a follow-up.

各位早安，謝謝回答問題。你們在新聞稿中提到，本季度相較去年同期的量（volume）成長 36%。我想知道如果改和去年第四季相比，讀數會是什麼？另外我還有一個追問。

Sandra, do you have the quarter-on-quarter growth off the top of your head? Sandra, you might be on mute.

Sandra，你是否能直接說一下季度對季度的成長率？Sandra，你可能在靜音。

Apologies, You're correct. I was on mute. I want to say we're mid-20% volume growth from Q1 2026 over Q4 2025.

抱歉，您說得對。我剛剛在靜音。我想說的是，從2025年第四季到2026年第一季，我們的量成長在20%中段。

Okay. Great. That's very helpful. Maybe just a follow-up here that we know that the referral, obviously, is the long-term sort of expansion sources. And so we know that you guys already started the process.

好的。很好。這非常有幫助。也許這裡再追問一下，我們知道轉介顯然是長期的那種擴張來源。所以我們知道你們已經開始這個流程了。

And just curious what will be the measurement or other sort of follow-up to track how the referral track is being done and improvements if needed, so on and so forth. So any color on that front? And thanks.

只是好奇，你們會用什麼衡量方式或其他追蹤機制，來追蹤轉介管道的執行情況，以及在需要時進行改善等等。所以在這方面能否提供一些補充說明？謝謝。

Yeah, It's interesting that you asked that question because it's something I've grappled with Kevin. Just what we want to do is incentivize our oncology managers to get the referrals going. It is somewhat difficult to know when the patient shows up at the center because obviously, we have the compliance. You can't exactly quiz the doctor on where did this patient come from that sort of thing.

是的，你問這個問題很有意思，因為這也是我一直在和Kevin一起思考的事情。我們想做的就是激勵我們的腫瘤科經理把轉介推動起來。但要知道病人何時出現在中心其實有點困難，因為顯然我們有合規要求。你不可能真的去盤問醫師說這位病人是從哪裡來的之類的。

So, it's difficult to know, hey, did our referral process lead to this specific patient. We definitely know of cases, many, many cases where the work of the oncology manager resulted in a patient ending up at one of our treating centers. So, it is working. In terms of measuring it on a specific metric, we're grappling with that an accurate metric. We're grappling with that ourselves.

所以很難知道，嘿，我們的轉介流程是否帶來了這位特定病人。我們確實知道有很多很多案例，腫瘤科經理的工作讓病人最後來到我們其中一個治療中心。所以它確實有效。至於要用某個特定指標來衡量，我們正在苦思一個準確的指標。我們自己也在摸索。

How do we follow that. We have some ideas. But right now, I can't point to a specific way we're going to measure that. And it's unlikely that we're going to be able to tell you ever get to the point where we can say, hey, X percent of our patients or the rate of referral is Y per site. I don't think we'll ever get there.

要怎麼追蹤這件事。我們有一些想法。但目前我還無法指出我們會用哪一個具體方式來衡量。而且我們不太可能有一天能告訴你們，嘿，X% 的病人是我們轉介來的，或每個據點的轉介率是 Y。我不認為我們會走到那一步。

Because again, it's HIPAA compliant, you can't quiz the docs, but we're focused very, very much on it.

因為同樣地，這要符合HIPAA，你不能去盤問醫師，但我們非常非常專注在這件事上。

Okay, great. That's very helpful and thanks and congrats.

好的，很好。這非常有幫助，謝謝，也恭喜。

Charles Wallace, H.C. Wainwright.

Charles Wallace，H.C. Wainwright。

Hi, This is Charles on for RK from H.C. Wainwright. So, the first question I have is, I was curious for the CHOPIN publication in the ESMO clinical practice guidelines, are you seeing these two publications translate into increased physician adoption in Europe? I know it's a little early, but should we expect kind of that to grow in 2026 from these?

嗨，我是Charles，代表H.C. Wainwright的RK來提問。我第一個問題是，我想了解CHOPIN在ESMO臨床實務指引中的發表，你們是否看到這兩篇發表轉化為歐洲醫師採用度的提升？我知道現在可能還有點早，但我們是否應該預期這會在2026年帶動成長？

Yeah, I think the European growth is significantly hampered by reimbursement issues. I think many centers in Europe are doing a combination type regime. But to be frank, a lot of European oncologists are less aggressive than they are in the US. But I can't really comment as to whether or not I think is it going to grow to increase revenue in Europe over the long-term, certainly.

是的，我認為歐洲的成長受到給付（報銷）問題的顯著限制。我認為歐洲許多中心在做的是某種組合型療程。但坦白說，很多歐洲腫瘤科醫師沒有美國那麼積極。不過我無法真正評論我是否認為長期來看它會在歐洲成長並帶動營收增加，當然長期是有可能的。

For this particular year, I think we just have to assume that we're going to see probably modest single-digit growth in Europe. What will change that is getting reimbursement in the UK which we've been working on for quite a while as well as establishing commercial businesses in Spain, France and Italy, and we're working hard on that as well.

就今年而言，我想我們只能假設歐洲大概會是溫和的個位數成長。能改變這點的是在英國取得給付，我們也已經努力了一段時間；以及在西班牙、法國和義大利建立商業化業務，我們也正在積極推進。

In terms of the overall impact on the business, given the price point in Europe, I wouldn't just call it a rounding error, certainly, but it's a plus or minus 10% thing on EBITDA for the business. It's not a huge driver. But we're focused on Europe, as I've mentioned before, primarily at least for the short to medium-term as areas where we can generate data. The drug is approved, the device is approved to deliver melittin to the liver. It is not tied to a specific tumor type.

就對整體業務的影響而言，考量歐洲的定價，我不會說它只是四捨五入的誤差，當然不是，但對公司EBITDA而言大概是正負10%的影響。它不是很大的驅動因素。但我們仍然專注在歐洲，如我之前提過的，至少在短中期主要是把它當作可以產生數據的區域。藥物已獲核准，裝置也已獲核准用於將melittin輸送至肝臟。它不與特定腫瘤類型綁定。

Now most of the usage is in uveal melanoma because that's where most of the data is. But it's a great place to generate run IITs and generate data in other tumor types. So right now, Europe's importance is generation of data. We manage it on a breakeven basis. At some point, we may relaunch the product as a combination drug device as a HEPZATO and try to reset the price point, but that's many, many years down the road.

目前大多數使用是在葡萄膜黑色素瘤，因為那是數據最多的領域。但這也是一個很好的地方，可以啟動研究者發起試驗（IIT）並在其他腫瘤類型上產生數據。所以目前歐洲的重要性在於產生數據。我們以損益兩平為目標來管理。未來某個時點，我們可能會以藥械組合的形式、以HEPZATO重新推出產品並嘗試重設價格點，但那是很多很多年以後的事。

Yeah, thank you for all the color. I guess one more follow-up for me. So, on the pipeline for mCRC, I think you mentioned that there's 13 sites, but it's been slower-than-expected enrollment with -- I think you said seven patients. So, I was just curious when you expect enrollment to pick up and ultimately complete for this study? Thank you.

是的，謝謝你提供這麼多補充說明。我還有一個追問。關於mCRC的研發管線，我想你提到有13個據點，但收案比預期慢——我記得你說目前是7位病人。所以我想請教你預期何時收案會加速，並最終完成這項研究？謝謝。

Sure. Vojislav, you mind taking that?

當然。Vojislav，你介意回答一下嗎？

Sure. You're correct. We have opened 13 sites, and we have enrolled thus far seven patients. Based on the momentum that we've observed over the last several months, we feel confident that the momentum, both in terms of site openings and patient screening and enrollment is picking up. So, we believe that enrollment will proceed in this year and next year and that we'll be able to share interim results publicly by the end of next year, '27.

當然。你說得沒錯。我們已開啟13個據點，截至目前已收案7位病人。根據我們過去幾個月觀察到的動能，我們有信心動能正在提升，無論是在據點開啟，或病人篩選與收案方面。因此，我們相信收案會在今年與明年持續推進，並且我們將能在明年（'27）年底前對外公開分享期中結果。

Okay, thank you for taking my questions.

好的，謝謝回答我的問題。

Thank you. We have reached the end of the question-and-answer session. And this concludes today's conference, and you may now disconnect your lines. Thank you all for your participation.

謝謝。我們已到達問答環節的結束。今天的會議到此結束，您現在可以掛斷電話線。感謝各位的參與。