Mediwound Ltd (MDWD) 2026 Q1 法說會逐字稿

Good day, and welcome to the MediWound first quarter 2026 earnings conference call. (Operator Instructions) Please note today's event is being recorded. I'd now like to turn the conference over to Dan Ferry of Lifesci Advisors. Please go ahead.

各位早安，歡迎參加 MediWound 2026 年第一季財報電話會議。（接線員指示）請注意，今日活動將進行錄音。現在我想將會議交給 Lifesci Advisors 的 Dan Ferry。請開始。

Thank you, operator, and welcome, everyone. Earlier today, pre-market open, MediWound issued a press release announcing financial results for the first quarter ended March 31, 2026. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward-looking statements within this morning's press release.

謝謝，接線員，也歡迎各位。今天在盤前開盤前，MediWound 發布新聞稿，公布截至 2026 年 3 月 31 日止第一季的財務結果。您可在公司網站「投資人」分頁下查閱該新聞稿。我也請各位閱讀今早新聞稿中關於前瞻性陳述的完整文字。

Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to MediWound's expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC.

在開始之前，我想提醒各位，本次電話會議（包含問答環節）中所作之陳述，凡涉及 MediWound 預期未來表現、未來業務前景或未來事件或計畫者，均屬 1995 年《私人證券訴訟改革法》所定義之「前瞻性陳述」。此等陳述可能涉及風險與不確定性，可能導致實際結果與預期存在重大差異，相關內容已在我們向美國證券交易委員會（SEC）提交的文件中更完整地說明。

In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether a result of new information, future events or otherwise. This conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound.

此外，所有前瞻性陳述僅代表我們截至今日的觀點；MediWound 不承擔更新或補充任何前瞻性陳述之義務，無論係因新資訊、未來事件或其他原因。本電話會議為 MediWound 之財產，未經 MediWound 書面同意，明確禁止任何錄音或轉播。

With us today are Ofer Gonen, Chief Executive Officer of MediWound; and Hani Luxenburg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating in today's call. Following our prepared remarks, we will open the call for Q&A.

今天與會者包括 MediWound 執行長 Ofer Gonen，以及財務長 Hani Luxenburg。策略與企業發展執行副總裁 Barry Wolfenson 也將參與本次電話會議。在我們的準備發言之後，將開放問答。

Now I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer?

現在我想把電話會議交給 MediWound 執行長 Ofer Gonen。Ofer？

Thank you, Dan, and good morning, everyone. During the first quarter of 2026, we continue to execute against our key strategic priorities, advancing EscharEx towards commercialization and expanding the global role of NexoBrid. While the timeline for EscharEx Phase III VALUE study has shifted by one quarter, the underlying momentum behind the program continues to strengthen.

謝謝你，Dan，各位早安。2026 年第一季，我們持續執行關鍵策略優先事項，推進 EscharEx 邁向商業化，並擴大全球對 NexoBrid 的採用。雖然 EscharEx 第三期 VALUE 研究的時程延後了一季，但該計畫背後的動能仍持續增強。

During this quarter, we expanded our chronic wound collaboration network, generated additional clinical and scientific validation for both EscharEx and NexoBrid and continue to see strong engagement from strategic collaborators and the broader wound care community. We continue to advance our expanded NexoBrid manufacturing facility towards commercial readiness and further strengthen long-term opportunities with industry leaders and government partners across our portfolio.

本季我們擴大了慢性傷口合作網絡，為 EscharEx 與 NexoBrid 取得更多臨床與科學驗證，並持續看到策略合作夥伴及更廣泛傷口照護社群的高度參與。我們也持續推進擴建後的 NexoBrid 製造設施，朝商業化就緒邁進，並在整體產品組合上，進一步強化與產業領導者及政府合作夥伴的長期機會。

Let me start with an update on EscharEx. Enrollment continues in the global Phase III VALUE study in venous leg ulcers with more than 30 sites active across the United States, Europe and Israel. Recruitment has progressed more gradually than originally anticipated, primarily due to 2 operational factors.

我先從 EscharEx 的最新進展談起。針對靜脈性腿部潰瘍（VLU）的全球第三期 VALUE 研究持續收案，目前在美國、歐洲與以色列已有超過 30 個試驗中心啟動。招募進度較原先預期更為緩慢，主要是由於兩項營運因素。

First, certain European sites required ancillary-related regulatory adjustments, which have been now completed, and we expect the study to reach the targeted 40 active sites within weeks. Second, the travel and visit requirements associated with the protocol created participation challenges for the older and medically complex VLU patient population. To support enrollment and reduce participation burden, we implemented patient assistance measures, including hotel reimbursements, transportation services and facilitated access to enhanced care.

第一，部分歐洲試驗中心需要就輔助性（ancillary）相關事項進行法規調整，目前已完成；我們預期在數週內可達成目標的 40 個啟動試驗中心。第二，研究方案所要求的差旅與回診安排，對年長且病況較複雜的 VLU 病患族群造成參與上的挑戰。為支持收案並降低參與負擔，我們已導入病患協助措施，包括旅館費用補助、交通接送服務，以及協助取得加強型照護。

Importantly, given how quickly EscharEx works, the protocol requires daily wound assessment to determine the exact day complete debridement is achieved. This represents a shift from measuring debridement outcomes over weeks. While this creates operational complexity in the study, it may ultimately reflect one of EscharEx's key clinical and commercial advantages in real-world practice. Investigator engagement and site participation remains strong across all regions, and we expect the interim sample size reassessment and the enrollment completion by the end of the first quarter of 2027.

重要的是，由於 EscharEx 的作用速度很快，研究方案要求每日進行傷口評估，以判定達成完全清創的確切日期。這與以往以數週為尺度衡量清創結果的方式不同。雖然這使研究在執行上更為複雜，但最終可能更能反映 EscharEx 在真實世界臨床使用中的關鍵臨床與商業優勢。各地區研究者的投入與試驗中心參與度仍然強勁；我們預期將於 2027 年第一季末完成期中樣本數重新評估與收案完成。

At the same time, we continue to see expanding commercial, clinical and scientific validation supporting the broader opportunity of EscharEx across the chronic wound care market. Medline, a global leader in medical surgical and wound care products, has joined our collaboration network. Together with Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, B. Braun and MIMEDX, our collaborators now include essentially all the major advanced wound care companies relevant to the program.

同時，我們持續看到商業、臨床與科學層面的驗證不斷擴大，支持 EscharEx 在慢性傷口照護市場的更廣泛機會。全球醫療外科與傷口照護產品領導者 Medline 已加入我們的合作網絡。連同 Coloplast/Kerecis、Convatec、Essity、Mölnlycke、Solventum、B. Braun 與 MIMEDX，我們的合作夥伴如今幾乎涵蓋與該計畫相關的所有主要先進傷口照護公司。

As part of the collaboration, Medline will provide its class-leading skin protectant, Marathon, for the upcoming DFU Phase II study. Marathon is designed to protect tissue surrounding the wound, while EscharEx performed its debridement activity within the wound bed. A peer-reviewed US expert consensus document published in Wound Journal emphasized the need for effective, easy-to-use and less invasive debridement approaches in chronic wound care, a conclusion that aligns closely with the clinical profile and positioning of EscharEx.

作為合作的一部分，Medline 將為即將進行的糖尿病足潰瘍（DFU）第二期研究提供其同級最佳的皮膚保護劑 Marathon。Marathon 用於保護傷口周圍組織，而 EscharEx 則在傷口床內發揮其清創作用。一份經同儕審查、由美國專家共識撰寫並發表於《Wound Journal》的文件強調，在慢性傷口照護中需要有效、易用且侵入性較低的清創方法；此結論與 EscharEx 的臨床特性與定位高度一致。

We also presented new clinical data and new preclinical data at the WHS, SAWC and EWMA conferences, highlighting EscharEx's clinical benefits, distinct mechanism of action and broad potential across venous leg ulcers, diabetic foot ulcers and pressure ulcers.

我們也在 WHS、SAWC 與 EWMA 會議上發表新的臨床資料與新的臨床前資料，突顯 EscharEx 的臨床效益、獨特作用機轉，以及其在靜脈性腿部潰瘍、糖尿病足潰瘍與壓瘡等領域的廣泛潛力。

Turning to NexoBrid. During the quarter, we continue to see growing commercial adoption, clinical recognition and strategic interest in NexoBrid across both traditional burn care settings and government preparedness initiatives. Vericel reported continued growth in both ordering centers and total orders across the United States burn care market, reflecting ongoing adoption trends.

接著談 NexoBrid。本季我們持續看到 NexoBrid 在傳統燒燙傷照護場景與政府備援計畫中，商業採用度、臨床認可度與策略性關注度皆在提升。Vericel 報告指出，美國燒傷照護市場的下單中心數與總訂單量持續成長，反映採用趨勢仍在延續。

Most importantly, Vericel was also awarded a 10-year BARDA contract valued at up to $197 million to support NexoBrid procurement, vendor management inventory services, potential blast trauma indication development and next-generation manufacturing and formulation capabilities. We expect BARDA-related procurement and development to begin during the second half of 2026.

最重要的是，Vericel 亦獲得一份為期 10 年、最高可達 1.97 億美元的 BARDA 合約，用以支持 NexoBrid 採購、供應商管理庫存服務、潛在爆炸傷（blast trauma）適應症開發，以及下一代製造與配方能力。我們預期 BARDA 相關採購與開發將於 2026 年下半年開始。

This new 10-year BARDA contract builds on approximately $138 million already received from BARDA and the Department of War over the past decade, further solidifying the significance of NexoBrid as a strategic asset in mass casualty burn response and national preparedness.

這份新的 10 年期 BARDA 合約，建立在過去十年間已自 BARDA 與戰爭部（Department of War）取得約 1.38 億美元的基礎上，進一步巩固 NexoBrid 作為大規模傷亡燒傷應對與國家備援之策略性資產的重要性。

Importantly, the burn care community continues to move in the same direction. Newly published national consensus guidelines from Japan and the UK now added to existing recommendation from the WHO and countries, including Italy, Spain, Romania and Poland. To support this global demand, we remain focused on bringing our expanding manufacturing facility online. We are implementing modifications identified during a recent EMA pre-audit, and we expect to complete those implementations activities during the second half of 2026.

同樣重要的是，燒傷照護社群也持續朝同一方向前進。日本與英國新近發布的國家共識指引，已加入既有的 WHO 及包括義大利、西班牙、羅馬尼亞與波蘭等國的建議之列。為支援此全球需求，我們仍專注於讓擴建中的製造設施上線。我們正落實近期 EMA 預稽核所識別的修改事項，並預期於 2026 年下半年完成這些落實作業。

With that, I'll turn on the call to Hani. Hani?

接下來，我把電話會議交給 Hani。Hani？

Thank you, Ofer, and good morning, everyone. Let's turn to our financial results for the first quarter of 2026. Revenue for the quarter was $1.5 million compared to $4 million in the first quarter of 2025. The decrease was primarily attributable to timing of BARDA-related revenue as well as postponed shipment related to regional conflict.

謝謝你，Ofer，各位早安。接下來談 2026 年第一季的財務結果。本季營收為 150 萬美元，較 2025 年第一季的 400 萬美元下降。下降主要歸因於 BARDA 相關收入認列時點，以及因區域衝突而延後出貨。

Gross profit for the quarter was $0.3 million, representing a gross margin of 21.9% compared to gross profit of $0.7 million or a gross margin of 18.7% in the prior year period. Research and development expenses were $5.2 million compared to $2.9 million in the first quarter of 2025, primarily reflecting continued investment in the EscharEx VALUE Phase III study. SG&A expenses totaled $3.6 million compared to $3.1 million in the same period last year.

本季毛利為 30 萬美元，毛利率 21.9%，相較去年同期毛利 70 萬美元、毛利率 18.7%。研發費用為 520 萬美元，較 2025 年第一季的 290 萬美元增加，主要反映對 EscharEx VALUE 第三期研究的持續投入。銷售、一般及行政（SG&A）費用合計 360 萬美元，較去年同期的 310 萬美元增加。

Operating loss for the quarter was $8 million compared to $5.2 million in the first quarter of 2025. Net loss was $3 million or $0.23 per share compared to a net loss of $0.7 million or $0.07 per share in the prior year period. Adjusted EBITDA loss was $7 million compared to a loss of $4 million in the first quarter of 2025.

本季營業損失為 800 萬美元，較 2025 年第一季的 520 萬美元擴大。淨損為 300 萬美元或每股 0.23 美元，相較去年同期淨損 70 萬美元或每股 0.07 美元。調整後 EBITDA 虧損為 700 萬美元，較 2025 年第一季虧損 400 萬美元擴大。

Turning to our balance sheet. As of March 31, 2026, with $45 million in cash, cash equivalents and deposits compared to $54 million at year-end 2025. During the first quarter, net cash used in operating activity was $9.6 million, including the impact of foreign exchange movement between the US dollar and the Israeli shekel. Our balance sheet also benefited from $1.2 million received under the European Innovation Council (EIC) Accelerator grant program as well as $0.7 million received from the exercise of Series A warrants subsequent to quarter end.

接著看資產負債表。截至 2026 年 3 月 31 日，現金、約當現金及存款為 4,500 萬美元，較 2025 年底的 5,400 萬美元下降。第一季營運活動使用的淨現金為 960 萬美元，其中包含美元與以色列謝克爾之間匯率變動的影響。我們的資產負債表亦受惠於自歐洲創新委員會（EIC）加速器補助計畫取得的 120 萬美元，以及在季後因行使 A 系列認股權證而收到的 70 萬美元。

That concludes my review of the financials. Ofer, back to you.

以上就是我對財務狀況的檢視。Ofer，交回給你。

Thank you, Hani. We continue to make meaningful progress across our core strategic priorities, advancing EscharEx VALUE study, broadening industry validation, expanding NexoBrid commercial and government footprint and preparing our expanded manufacturing facility for commercial readiness.

謝謝你，Hani。我們在核心策略優先事項上持續取得實質進展，推進 EscharEx VALUE 研究、擴大產業驗證、拓展 NexoBrid 在商業與政府端的佈局，並為我們擴建的製造設施做好商業化就緒準備。

Based on the expected timing of the government-related procurement and the development revenue in the second half of the year, we are reaffirming our full year 2026 revenue guidance of $24 million to $26 million. Our focus remains on disciplined execution as we position the company for a potential inflection point in the next phase of commercial growth. Operator?

基於政府相關採購與下半年開發收入的預期時程，我們重申 2026 全年營收指引為 2,400 萬至 2,600 萬美元。我們仍聚焦於紀律性的執行，為公司在下一階段商業成長中可能出現的拐點做好定位。接線員？

Now begin the question-and-answer session.

現在開始問答環節。

(Operator Instructions)

（接線員指示）

Josh Jennings, TD Cowen.

Josh Jennings，TD Cowen。

Hi, good morning, Ofer and Hani. Thanks for the update. I wanted to just ask on the VALUE study and understand that there is some complexities in terms of evaluating some of the older patients and you described that well. But are there any other risks in terms of getting the interim analysis done by the end of 1Q '27?

嗨，早安，Ofer 和 Hani。謝謝更新。我想就 VALUE 研究提問；我理解在評估一些年紀較大的患者方面存在一些複雜性，你也描述得很清楚。但除此之外，在 2027 年第一季末前完成期中分析，還有其他風險嗎？

And has these adjustments been made already? And what are you seeing to date that gives you confidence that 1Q '27 is the appropriate new timeline?

另外，這些調整是否已經完成？以及截至目前你們看到了什麼，讓你們有信心認為 2027 年第一季是合適的新時間表？

Hi, Josh, good to speak to you. As I said, indeed, the enrollment has progressed more gradually than originally anticipated. But importantly, this is not related to, I don't know, safety, efficacy or protocol concern.

嗨，Josh，很高興和你交流。如我所說，確實，入組進度比原先預期更為緩慢。但重要的是，這並非與——我不知道——安全性、有效性或方案（protocol）方面的疑慮有關。

As I said in my prepared remarks that the slower pace is primarily reflected by all kind of operational factors that we believe are behind us. They are associated with running a very large multinational VLU study, the largest in a few decades. And those operational challenges were, as I said, ancillary-related regulatory adjustments at certain European sites, and it is done.

如我在事先準備的發言中所說，較慢的速度主要反映在我們認為已經克服的各種營運因素上。這些因素與執行一項非常大型的跨國 VLU 研究有關，這是數十年來規模最大的研究。而這些營運挑戰，如我所說，包含在部分歐洲站點所需的附帶性法規調整，且已完成。

We estimate that we reach approximately 40 active sites within weeks. We have also implemented targeted measures to support recruitment momentum with the transportation support, reimbursement programs and additional patient assistance initiatives.

我們預計在數週內達到約 40 個啟動中的站點。我們也已採取有針對性的措施以支持招募動能，包括交通支援、費用補助計畫以及額外的病患協助方案。

So according to what we see, believe and understand from how this study runs, we expect the enrollment to be completed by the end of 2027. I have to emphasize that we are focusing on making sure that the right patients are included in the study, not patients that placebo can cure the wound or not patients that even EscharEx cannot move the needle for them. So it takes time, but we feel that we are around nearing the end.

因此，根據我們對該研究運作方式的觀察、判斷與理解，我們預期入組將在 2027 年底完成。我必須強調，我們專注於確保納入研究的是合適的病患，而不是安慰劑就能治癒傷口的病患，也不是即使 EscharEx 也無法為其帶來明顯改善的病患。因此這需要時間，但我們覺得已接近尾聲。

Thanks for the extra detail. I appreciate it. And just in terms of the expanded manufacturing capacity for NexoBrid and looking at the regulators and the updates that you shared on the call, just the FDA inspection is planned in early 2027.

謝謝你補充這些細節，我很感謝。再就 NexoBrid 擴增的製造產能而言，結合你們在電話會議中分享的監管進展與更新，FDA 的查廠計畫是在 2027 年初。

Any just next steps on getting the FDA in there? I mean what are the steps in front of that inspection occurring in 2027? And when should we expect that facility to come online to be able to supply NexoBrid product in the US?

在讓 FDA 進場方面，接下來的步驟是什麼？也就是說，在 2027 年進行該次查廠之前，還有哪些前置工作？以及我們應該何時預期該設施上線，以便能供應美國市場的 NexoBrid 產品？

Yeah so indeed, the US inspectors are supposed to come very early 2027. But in order to do that, we need to finalize with the EMA first. As you know, it's a very complex biologic manufacturing and the transfers includes all kind of process validations, comparability, stability and regulatory reviews.

是的，確實，美國稽查人員預計會在 2027 年初來訪。但在此之前，我們需要先與 EMA 完成相關工作。如你所知，這是一個非常複雜的生物製劑製造流程，技術轉移包含各種製程驗證、可比性、穩定性以及法規審查。

These activities are progressing, but they require very careful and disciplined execution. We had -- during the quarter, we completed an on-site pre-audit from EMA. They identified all kind of several recommendations that are operational modifications. We are now implementing them.

這些工作正在推進，但需要非常謹慎且有紀律地執行。本季度期間，我們完成了 EMA 的現場預稽核（pre-audit）。他們提出了若干建議，屬於營運層面的修改。我們目前正在落實。

And as I said in the call, we expect to complete these activities during the second half of 2026. The feedback is operational in nature. It doesn't have anything related to product quality, safety or comparability concerns. So we think that we are on the right track.

如我在電話會議中所說，我們預期在 2026 年下半年完成這些工作。回饋屬於營運性質，與產品品質、安全性或可比性疑慮無關。因此我們認為進展方向正確。

Understood. Appreciate. Thanks a lot over.

了解。謝謝，十分感謝，Ofer。

Thank you.

謝謝。

Jeff Jones, Oppenheimer

Jeff Jones，Oppenheimer。

Hi, this is Mira on for Jeff. Thanks for the update. Just a couple of questions regarding the manufacturing facility and the EMA pre-audit. Just wanted to understand sort of the impact of the recommended modifications by the EMA to the facility on material already manufactured.

嗨，我是代 Jeff 發言的 Mira。謝謝更新。關於製造設施與 EMA 預稽核，我有幾個問題。想了解 EMA 建議的設施修改，對已經製造出的物料會有什麼影響。

And what is your confidence in being able to sell that material out of the new facility before year-end and sort of that timeline to complete the implementation of these fixes? And would the EMA have to reinspect this? Thank you.

以及你們對於在年底前能夠從新設施銷售該等物料的信心如何、完成這些修正落實的時間表為何？另外，EMA 是否需要重新檢查？謝謝。

Hi, Mira, Good to have you on. So as I said, responded to Josh, we -- it wasn't the inspection. It was a pre-audit by the EMA. And they identified several recommended the operational modification. And when the agency recommends something, you know it's not a real recommendation, you need to do that.

嗨，Mira，很高興你加入。如我剛才回覆 Josh 所說，我們——那不是正式稽查，而是 EMA 的預稽核。他們提出了幾項建議的營運修改。而當主管機關提出建議時，你知道那其實不算「建議」，你必須去做。

So we are now implementing it.

所以我們現在正在落實。

According to what we understand, we can finish everything as we planned during the second half of 2026. The feedback was only operational, nothing related to the comparability of the product, the safety of it. And these are the things that are really worrying in manufacturing transfer of biologics. So we think that we are in a good place.

依我們的理解，我們可以如計畫在 2026 年下半年完成所有事項。回饋僅屬營運層面，與產品可比性或安全性無關。而這些才是生物製劑製造轉移中真正令人擔憂的部分。因此我們認為目前狀況良好。

Great. Just one additional question on the BARDA contract. I was wondering if you could comment on the portion of the base BARDA contract, that $35 million that goes to NexoBrid procurement and how you would expect that to flow to MediWound versus Vericel. Thank you.

很好。再補充一個關於 BARDA 合約的問題。我想請你們評論一下 BARDA 基礎合約中那 3,500 萬美元用於 NexoBrid 採購的部分，你們預期這部分會如何在 MediWound 與 Vericel 之間分配與流轉？謝謝。

So the only thing that I can share about at this stage at the BARDA contract is that the $197 million is a 10-year contract between BARDA and Vericel. It contains five components: procurement, we share it with Vericel, VMI management. Vericel is running that. And manufacturing readiness and next-generation formulation, another indication for blast trauma, we are -- we have a big share in bringing that to the market.

就目前階段我能分享的 BARDA 合約資訊只有：1.97 億美元是一份為期 10 年、由 BARDA 與 Vericel 簽訂的合約。它包含五個組成部分：採購（procurement），我們會與 Vericel 共享；VMI 管理由 Vericel 負責；以及製造就緒（manufacturing readiness）與下一代配方、另一個爆炸傷（blast trauma）適應症——我們在推動其上市方面占有很大比重。

Certain elements in the BARDA framework also includes the room temperature stable formulation, which is a program that initiated back in the days by the Department of War. And we expect those revenue to kick in, in the beginning of the second half of 2026. Unfortunately, I cannot tell you at this stage what is the share, who gets what and what is the portion of MediWound there.

BARDA 架構中的某些要素也包含室溫穩定配方（room temperature stable formulation），這個計畫早年由戰爭部（Department of War）啟動。我們預期相關收入會在 2026 年下半年初開始貢獻。很遺憾，我目前無法告訴你分成比例、誰拿多少，以及 MediWound 在其中的占比。

RK, H.C. Wainwright

RK，H.C. Wainwright。

Thank you. Good afternoon, Ofer and Hani. A couple of questions from me. So just thinking through the program with EscharEx beyond the current study, just trying to have an idea of how the additional studies which you are planning, especially on the indication expansion, the DFU and the IIT on pressure ulcer, how are those -- the plans for those studies and how are those studies progressing?

謝謝。午安，Ofer 和 Hani。我有幾個問題。首先，關於 EscharEx 在目前研究之外的計畫，我想了解你們規劃的後續研究，特別是適應症擴展方面，包括 DFU 以及針對壓瘡的 IIT，這些研究的規劃如何？目前進展如何？

Hi, okay, and Thanks for joining. So as we mentioned, the Phase III VALUE study in VLU remains the primary focus of the EscharEx development program, and this is the company's key value driver, as you can imagine. In parallel, we are conducting 40 studies that are required for regulatory submission, which is a PK study and human factor studies that we are about to start in the second half of the year.

嗨，好的，謝謝加入。如我們提到的，針對 VLU 的第三期 VALUE 研究仍是 EscharEx 開發計畫的首要重點，這也是公司最關鍵的價值驅動因素，你可以想像。同時，我們也在進行 40 項法規申請所需的研究，包括一項 PK 研究與人因（human factor）研究，我們預計在今年下半年啟動。

We are also advancing a head-to-head Phase II study versus collagenase or SANTYL and all kind of other nonsurgical standard of care modalities also to strengthen the differentiation between us and to support -- between us and the competition and to support future market access discussions. Beyond VLU, we are expanding EscharEx into additional chronic wound indications.

我們也在推進一項與 collagenase 或 SANTYL 的頭對頭第二期研究，以及各種其他非手術標準治療方式，以進一步強化我們的差異化、支持我們與競品之間的區隔，並支援未來的市場准入（market access）討論。除了 VLU 之外，我們也正將 EscharEx 擴展至其他慢性傷口適應症。

As we already communicated, we're about to start a Phase II study in diabetic foot ulcers in the second half of '26. As well as an investigator-initiated trial in pressure ulcers, which is planned also for the second half of 2026. This structured program is designed to support the regulatory approval, the competitive positioning of EscharEx and of course, the long-term commercial expansion across the major chronic wound segments.

如我們先前已溝通，我們預計在 2026 年下半年啟動糖尿病足潰瘍（DFU）的第二期研究；同時也規劃在 2026 年下半年啟動一項由研究者發起的壓瘡試驗（IIT）。這套結構化計畫旨在支持 EscharEx 的法規核准、競爭定位，當然也包括在主要慢性傷口領域的長期商業擴張。

Thank you. The second question is on the revenues. So, there is a statement saying some of the shipments had to be postponed because of the regional conflict. So just trying to understand what sort of -- how these shipments are going to be moved into the next three quarters?

謝謝。第二個問題是關於營收。有一段提到因區域衝突，部分出貨必須延後。我想了解這些出貨將如何在接下來三個季度中遞延或轉移？

And also, as you reconfirmed your guidance for the year, $24 million to $26 million, which means quite a bit of it is going to show up in the next nine months. Out of that, how much is NexoBrid revenue-based income? And how much is the income that you can get from the BARDA contract approval?

另外，你們也重申全年指引為 2,400 萬至 2,600 萬美元，這表示其中相當一部分會在未來九個月反映。在這之中，有多少是以 NexoBrid 營收為基礎的收入？又有多少是來自 BARDA 合約核准後可取得的收入？

Yeah, hi RK, So the first quarter revenue was low -- relatively low, primarily as said, due to timing. We did not have BARDA-related revenue in the quarter and certain shipments were indeed postponed due to the regional conflict. Those postponed shipments have already been completed, so this was a timing issue.

是的，嗨 RK，所以第一季營收偏低——相對偏低，主要如前所述，是因為時點因素。本季沒有 BARDA 相關營收，且部分出貨確實因區域衝突而延後。那些延後的出貨已經完成，所以這是時點問題。

As a result, we expect -- looking ahead, we expect revenue to be weighted towards the second half of 2026, driven primarily by the expected ramp-up in government-related development services and procurement activities.

因此，我們預期——展望未來，我們預期營收將偏向 2026 年下半年，主要由政府相關開發服務與採購活動預期加速放量所帶動。

So our reaffirming 2026 guidance of $24 million to $26 million is, as you understand, supported by expected government-related development services with burn mass casualty preparedness. So we are quite confident that the second half of the year will do the ramp-up, and we're still reaffirming our guidance for the revenue this year.

因此，我們重申 2026 年 $2,400 萬至 $2,600 萬的財測，如你所理解，是由預期的政府相關開發服務所支撐，並聚焦於大規模傷亡應變準備（burn mass casualty preparedness）。所以我們相當有信心下半年會出現放量，我們仍重申今年的營收指引。

Is it possible for me to ask one more question, please?

我可以再問一個問題嗎？

Sure.

當然。

Yes. So on the Medline partnership, how does that relationship help in the overall development of the product itself? And what do they bring to the table and just so that we understand their contribution to this development cycle.

好的。關於與 Medline 的合作夥伴關係，這段關係如何在產品本身的整體開發上提供幫助？他們能帶來什麼？也請讓我們了解他們在這個開發週期中的貢獻。

Barry, do you want to speak on this?

Barry，你要談談這個嗎？

Sure, absolutely. RK, thanks for the question. Generally, as an overall comment, obviously, we believe that the level of industry engagement around EscharEx is highly significant. As Ofer mentioned in his comments, with Medline joining this quarter, our collaboration network essentially comprises all of the major relevant advanced wound care companies.

當然，沒問題。RK，謝謝你的問題。一般來說，作為整體評論，很明顯我們認為圍繞 EscharEx 的產業參與程度非常重要。如 Ofer 在他的評論中提到的，隨著 Medline 在本季加入，我們的合作網絡基本上涵蓋了所有主要且相關的先進傷口照護公司。

So along with Medline, it's Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, B. Braun and MIMEDX. These collaborations reflect growing recognition that chronic wound care continues to need an optimally effective, easy-to-use nonsurgical debridement solution, which we offer with EscharEx. And again, generally speaking, standardizing these key products used in both arms of the study, allowing us to only change one thing, active versus control, helps to minimize variability in the various studies and thus yield the best results.

因此，除了 Medline 之外，還包括 Coloplast/Kerecis、Convatec、Essity、Mölnlycke、Solventum、B. Braun 以及 MIMEDX。這些合作反映出市場日益認同：慢性傷口照護仍需要一個最佳有效、易於使用的非手術清創解決方案，而 EscharEx 正提供了這樣的方案。再者，概括而言，在研究的兩個組別中將這些關鍵產品標準化，讓我們只改變一個變因——有效成分組對照組——有助於降低各研究中的變異性，從而產出最佳結果。

Regarding Medline specifically, the product that they're going to provide is, again, for the DFU study, and it's their class-leading cyanoacrylate-based product, Marathon. So its job is to protect the healthy skin that surrounds the wound, which is an important component of standard of wound care, and that allows EscharEx to really just do its job within the wound bed itself.

就 Medline 而言，他們將提供的產品同樣是用於 DFU 研究，為其同級領先的氰基丙烯酸酯（cyanoacrylate）基產品 Marathon。它的作用是保護傷口周圍的健康皮膚，這是標準傷口照護的重要組成部分，並讓 EscharEx 能夠真正只在傷口床內發揮作用。

So the collaborators get the benefit of having their products as standard of care in some of the largest, most substantial clinical studies in the field of advanced wound care. which could have meaningful commercial impact for their brands. Medline will be looking at data after the study with regard to the health of the surrounding or periwound tissue around the wounds to see if indeed use of their product in a large-scale study helped to keep all of that periwound in very good condition.

因此，合作夥伴可受益於其產品在該領域規模最大、最具份量的一些先進傷口照護臨床研究中作為標準照護使用，這可能對其品牌帶來具意義的商業影響。Medline 會在研究後檢視與傷口周邊或傷口周圍（periwound）組織健康相關的數據，以確認在大型研究中使用其產品是否確實有助於讓周邊組織維持在非常良好的狀態。

From our perspective, the relationships with the research collaborators are strong, and any one of them could develop into a key strategic partner as EscharEx approaches commercialization.

從我們的角度來看，與研究合作夥伴的關係很穩固，其中任何一家都可能在 EscharEx 走向商業化之際，發展成關鍵的策略夥伴。

Perfect. No, thank you. Thank you all for taking all my questions. I appreciate it.

太好了。不，謝謝你。謝謝各位回答我所有問題，我很感激。

Thank you.

謝謝。

Chase Knickerbocker, Craig-Hallum.

Chase Knickerbocker，Craig-Hallum。

Good morning. Thanks for taking the questions maybe just to start, could you elaborate a little bit more on that regulatory change is causing some issues in Europe? I know you talked a little bit about it last quarter, but maybe if you could just remind us.

早安。謝謝讓我提問。先從這裡開始，你們能否再多說明一下，在歐洲造成一些問題的那項法規變更？我知道你們上季有稍微提到，但能否請你們再提醒我們一下。

And then is this responsible for the entirety of that difference between the current kind of 30-ish sites versus kind of the 40 target? Is that delta of 10 all in Europe?

另外，這是否就是目前約 30 個左右站點與目標約 40 個站點之間差異的全部原因？那 10 個站點的落差是否全部都在歐洲？

Hey, Chase, good to have you with us. Yes. First of all, the 10 sites that we are speaking about, all of them are European ones, and they will be open within weeks. As I think I shared with you in the past, specifically, some of the ancillaries that we need to import to Europe are a little bit problematic, specifically without mentioning the brand, cellular tissue products are not or were not allowed in specific countries in Europe, and it was a nightmare to bring them in.

嗨，Chase，很高興你加入。是的。首先，我們所說的那 10 個站點全部都在歐洲，而且會在幾週內開啟。正如我過去和你分享的，特別是我們需要進口到歐洲的一些輔助材料有點棘手；具體來說（不提品牌），細胞組織產品（cellular tissue products）在歐洲某些國家不被允許或曾不被允許，導入的過程非常痛苦。

And even if we had some resolutions, they were very local and to make it on a global scale was a little bit complicated. But now we can officially tell you that we are after it and all the sites are being open, and it is going to be executed. What was the second part of the question, sorry?

即使我們取得了一些解決方案，那些也非常在地化，要把它擴展到全球尺度就有點複雜。但現在我們可以正式告訴你，我們已經在處理這件事，所有站點都在開啟中，而且會被執行。抱歉，問題的第二部分是什麼？

Yeah, both are. Maybe just secondly, as far as what the 1Q '27 timeline kind of assumes for an enrollment rate, does it assume kind of an acceleration?

是的，兩個都是。第二點，關於 2027 年第一季（1Q '27）的時程，你們對收案速度的假設是什麼？是否假設會加速？

I mean, maybe just talk about the assumptions you're making within that. And then secondly, just as it relates to some of those changes around the travel reimbursement, et cetera, have you seen kind of an improvement in enrollment rate already from that?

也就是說，請談談你們在這方面做了哪些假設。然後第二個問題是，關於差旅補助等方面的一些變更，你們是否已經看到收案速度因此有所改善？

So Barry will address the second part of the question about the changes. But as for the first Q of 2027, our assumption that the enrollment per site, the number of patients per site to be enrolled per territory will be maintained. We will have more sites and we had some -- and eventually, we'll get there.

關於變更的第二部分，Barry 會回答。但就 2027 年第一季而言，我們的假設是：每個站點的收案量、每個區域每個站點要收的病人數將會維持。我們會有更多站點，而且我們也有一些——最終我們會達成。

As I said in the beginning of the call, our main motivation since there is a huge need for biologics, and Barry will elaborate on that in a second, there is a huge need for biologics in the market. We just need to make it to the finish line and make sure that the trial is success.

如我在電話會議一開始所說，我們的主要動機是：由於市場對生物製劑有巨大的需求——Barry 等一下會進一步說明——市場對生物製劑的需求非常大。我們只需要走到終點線，並確保試驗成功。

So there is no compromise in adding patients with all kind of exclusion criteria that we think will be too easy to cure for placebo or too tough to cure for EscharEx. We are keeping them out. We have more than thousands of patients that were already screened for this study.

因此，在納入病人方面我們不會妥協，不會因為各種排除標準而放寬；我們認為有些病人對安慰劑太容易痊癒，或對 EscharEx 來說太難治癒，我們都會排除。我們已經為這項研究篩檢了數以千計的病人。

So it means that there isn't a lack of patients. We just need to make sure that the patients that are enrolled are the right ones in order for us to be able to replicate the data that we had in previous studies. Barry, do you mind addressing the second part of the question?

這表示病人並不缺。我們只需要確保納入的病人是正確的，才能複製我們在先前研究中取得的數據。Barry，你介意回答問題的第二部分嗎？

Sure. I think Chase, I think that the question was directed towards whether or not these changes have impacted enrollment. And I guess what I would say about that is not likely. As Ofer just mentioned, we've had so many patients screened already. It's not for lack of patients and also talking to the sites before the study and during this last year, none of them said that anything having to do with reimbursement changes was impacting their ability to enroll patients or not.

當然。我想 Chase 的問題是，這些變更是否影響了收案。我會說，可能不太會。如 Ofer 剛提到的，我們已經篩檢了非常多病人，並不是病人不足；而且在研究開始前以及過去一年與各站點溝通時，沒有任何站點表示與補助/報銷（reimbursement）變更相關的事情會影響他們是否能收案。

And just in general, what Chase is referring to is this major change in the Medicare Physician Fee Schedule that happened at the end of last year, which was a major change reclassifying the skin substitutes to be paid as incident to supplies and establishing a standardized per square centimeter payment, which really lowered the overall sort of amount of dollars, if you will, flowing into that segment, so much so that CMS itself stated that the change is expected to reduce Medicare spending on those skin substitutes by nearly 90%, so which effectively translates to around $12 billion out of what was a $14 billion segment.

而一般而言，Chase 指的是去年年底 Medicare Physician Fee Schedule 的重大變更：這是一項重大調整，將皮膚替代物（skin substitutes）重新分類為「隨附於（incident to）」的耗材給付，並建立按每平方公分的標準化支付，這確實大幅降低了流入該細分市場的整體金額；以至於 CMS 自己都表示，該變更預期將使 Medicare 在這些皮膚替代物上的支出減少近 90%，等同於從原本約 140 億美元的市場中移除約 120 億美元。

That, in turn, will drop the whole US chronic wound care market from around $18 billion down to $5.5 billion. And in fact, over the last month or so, we've heard leading CTP companies reporting year-over-year declines in sales of around 60%. As Medicare closes that loophole, setting aside the clinical trial environment from a commercial opportunity, differentiated products outside this reimbursement construct will definitely stand out.

這反過來會使整體美國慢性傷口照護市場從約 180 億美元降至 55 億美元。事實上，在過去一個月左右，我們聽到領先的 CTP 公司回報其銷售年減約 60%。隨著 Medicare 補上這個漏洞，先撇開臨床試驗環境不談，從商業機會角度來看，在此報銷架構之外、具差異化的產品將會明顯脫穎而出。

EscharEx, for example, if approved, enters into a segment where a legacy product generates $400 million per year, and it places it as one of, if not the most valuable near-term asset in the field of wound care. Given the dramatic drop-off of these CTPs, certainly, the larger global wound care companies will very likely all shift their attention to products with higher order levels of regulatory approval, BLAs, NDAs, PMAs. And ours is one of the very few of those in late stages of clinical development.

例如 EscharEx，若獲核准，將進入一個既有產品每年可創造 4 億美元營收的細分領域，並使其成為傷口照護領域中最有價值、或至少是最有價值之一的近期資產。鑑於這些 CTP 的需求/銷售大幅下滑，較大型的全球傷口照護公司很可能都會把注意力轉向具有更高層級法規核准的產品——BLA、NDA、PMA。而我們是少數幾個處於臨床開發後期階段的此類產品之一。

And I'd add it's the only one heading into an existing proven category. So from a -- while it doesn't really impact or doesn't seem to have impacted the clinical study from a commercial perspective, this change is enormous for us.

我再補充一點：它也是唯一一個正邁向既有、已被證實的類別。因此，雖然從商業角度來看，這項變更對我們是巨大的利多，但它並未真正影響、或看起來並未影響臨床研究。

Helpful color, guys. Thank you.

很有幫助的補充資訊，各位。謝謝。

Michael Okunewitch, Maxim Group

Michael Okunewitch，Maxim Group

Hey there. Thank you so much for taking my questions today.

大家好。非常感謝今天讓我提問。

Hi, Michael.

嗨，Michael。

I think to start off, I'd like to ask a little bit about the consensus document published in Wounds. And in particular, if you could expand on what the driving rationale for the consensus on less aggressive methods earlier in the debridement course and what this could mean for EscharEx adoption?

我想先從《Wounds》上發表的共識文件談起。特別是，能否請你們進一步說明：為什麼在清創療程的較早階段會更強調採用較不具侵入性的方法？以及這對 EscharEx 的採用可能意味著什麼？

Is this something that could further build on that expectation that something like EscharEx could expand the share of enzymatic debridement in the overall chronic wound debridement segment? I'd just like to get your thoughts on that.

這是否可能進一步強化市場對於像 EscharEx 這類產品能夠提升酵素性清創在整體慢性傷口清創市場中占比的預期？想聽聽你們的看法。

Hi, Michael, I think, Barry, it's the best that you respond to that, okay?

嗨，Michael，我想，Barry，這題最好由你來回答，好嗎？

Sure. Michael, thanks for the question. We viewed the recent consensus publication, which was in Wounds as an important external validation of the direction that the field is moving. To your question specifically about why more of a focus on less invasive modalities early, I think it's just to allow for more broad access. The higher level of complexity of the intervention, the more training that someone would need to do that.

當然。Michael，謝謝你的問題。我們認為近期發表在《Wounds》的共識出版物，是對本領域發展方向的重要外部驗證。針對你特別問到為何在早期更聚焦於較不具侵入性的治療方式，我想主要是為了讓更多場域能夠使用。介入方式的複雜度越高，執行者所需的訓練就越多。

And if you know much about the wound care market, you know that wounds are treated in lots of different places from nursing homes in home care obviously, in the wound clinics and physicians' offices all the way up to and including hospitals, of course. And so there -- one of the charts that they have in the consensus document, they talk about it almost like a Chutes, and they talk about it as a Chutes and Ladders kind of approach where you start off at the base with these more easy-to-use products and then you progressively go higher and higher as it's required.

如果你對傷口照護市場有所了解，就會知道傷口是在許多不同場所被治療：從安養機構、居家照護，當然也包括傷口門診與醫師診所，一直到醫院等。因此——在該共識文件中的其中一張圖表，他們幾乎把它描述成「溜滑梯」的概念，並以「蛇梯棋（Chutes and Ladders）」的方式來說明：你從底部開始使用較容易上手的產品，然後在需要時逐步往上，採用更高階的方式。

And then even after you get to the top, as you sort of come down from that, you might need kind of check-ins, if you will, for maintenance debridement with the more easy-to-use products. Overall, the way that we see it and to your question of how does this -- what does this really translate to for EscharEx, the way that we view this, not that they used these words in that consensus document, but the very accurate picture that they drew of the market, the segment is one of a lot of confusion and a lot of moving parts.

而且即使你到了頂端，當你從那個階段往下回到較低強度的處置時，可能仍需要用較容易使用的產品做一些「回診式」的維持性清創。整體而言，回到你的問題：這對 EscharEx 實際意味著什麼？我們的看法是——雖然他們在共識文件中未必用這些字眼——但他們對市場描繪得非常精準：這個細分市場充滿混亂，且牽涉很多變動因素。

And the reason for that is the products that they consider to be first line, which are autolytic hydrogel types of moist wound care and the current enzymatic product are not deemed to be optimally clinically effective. Yes, they could be used in all settings. Yes, you don't need a lot of training to do them, but the debridement is measured in weeks.

原因在於，他們認為的一線產品——也就是自溶性（autolytic）的水凝膠類濕性傷口照護，以及現有的酵素性產品——在臨床效果上並不被視為最佳。是的，它們可以在各種場域使用；是的，執行不需要太多訓練；但清創的時間尺度是以「週」來計算。

So that kind of forces clinicians' hands to go up that ladder and get to more invasive approaches. How EscharEx changes that entire dynamic is by, yes, having a product that's easy to use, yes, having a product that could be used across all settings, but most importantly, is optimally effective where debridement can be measured in days.

因此，這會迫使臨床人員不得不往那個梯子上爬，改採更具侵入性的方式。EscharEx 改變整個動態的地方在於：它確實是一個容易使用的產品，也確實可以跨各種場域使用，但最重要的是，它的效果可達到最佳化，清創可以用「天」來衡量。

According to the data from third-party research, we do believe that because of that change, that EscharEx will significantly increase the market size of the overall enzymatic debridement market. When we look at from a pricing perspective and a relative desire to switch to EscharEx between diabetic -- while SANTYL is around $400 million a year, for EscharEx, we believe that peak sales reaches up to around $831 million just from venous leg ulcers and diabetic foot ulcers alone. So yes, we do anticipate a good amount of market expansion.

根據第三方研究數據，我們確實相信，因為這樣的改變，EscharEx 將顯著擴大整體酵素性清創市場的規模。從定價角度以及在糖尿病相關傷口等適應症中轉換到 EscharEx 的意願來看，雖然 SANTYL 年銷售額約為 4 億美元，但對 EscharEx 而言，我們認為僅靜脈性腿部潰瘍與糖尿病足潰瘍兩個適應症，峰值銷售就可達約 8.31 億美元。因此，是的，我們預期市場會有相當程度的擴張。

All right. And then just one more for me before I hop into the queue. Just with the enrollment challenges in VALUE, are there any lessons learned that you think you can carry over to streamline future development for EscharEx, whether that's for the supplementary studies or for the potential expansion studies into DFU and pressure ulcers?

好的。那我再問最後一題，之後我就回到隊列。關於 VALUE 試驗的收案挑戰，你們是否有任何經驗教訓可以沿用，以便在 EscharEx 未來的開發上更精簡流程——不論是補充性研究，或是未來擴展到 DFU 與壓瘡的研究？

Well, there are many lessons -- tactical lessons learned. The only one that I think is a change that we will take into account in future trials is that the enrolling rate, which is half a patient per site per month, which was a correct number when there was COVID, people were looking for excuses to go out of their home, physicians' offices were empty.

確實有很多——戰術層面的——經驗教訓。我認為我們在未來試驗中會納入的一個改變是：收案速率的假設。當時我們用的是每個中心每月 0.5 位病人，這在 COVID 期間是合理的，因為人們想找理由出門，醫師診所也很空。

These numbers should be reduced in our future calculation when we say end of Q1, we are counting on a lower number, making sure that we recruit the right patients. So all the others, additional money for transportation, make sure not to import to Europe all kind of complicated products, we are after that, and I don't think it will be an issue next time.

在我們未來的估算中，這些數字應該要下修；當我們說到第一季末時，我們會以較低的數字來規劃，並確保招募到合適的病人。其他方面，例如提供更多交通補助、避免把各種複雜產品運到歐洲，我們都已經處理過了，我不認為下次會是問題。

Alright, thank you very much.

好的，非常感謝。

Thank you.

謝謝。

Scott Henry, AGP

Scott Henry，AGP

Thank you. Good morning or afternoon, depending on your location. A follow-up -- a bit of a follow-up on RK's question, perhaps a little more specific. How dependent is 2026 revenue guidance on increasing manufacturing capacity?

謝謝。早安或午安，取決於你所在的位置。針對 RK 的問題做個追問，可能更具體一些。2026 年營收指引在多大程度上取決於提升製造產能？

And if that comes in towards the back part in Q4, is that a risk? Or can you build inventory ahead and such that you ship a lot in that quarter? Just trying to get a sense as we get later into the year.

如果產能提升要到第四季後段才到位，這會是風險嗎？還是你們可以提前建立庫存，讓那一季大量出貨？我想了解一下，因為我們越接近年底就越關鍵。

So hi, Scott, good to hear from you. So I'm following up, Hani, if this is okay, on what you said earlier. So we -- the forecast of 2026 is dependent on -- substantially on development services from all kind of government-related agreements. Specifically, we have some flexibility.

嗨，Scott，很高興聽到你的聲音。我接續一下你先前提到的內容，Hani，如果可以的話。我們對 2026 年的預測，主要取決於各類政府相關協議所帶來的開發服務（development services）。具體而言，我們有一定彈性。

It's not that our guidance of $24 million to $26 million is assuming specific revenue from products or from revenue from development services. We know that we can do either this one or that one. We feel quite comfortable with the guidance, and we are not dependent specifically on the manufacturing capacity.

我們給出的 2,400 萬到 2,600 萬美元指引，並不是假設一定要有特定的產品收入或特定的開發服務收入。我們知道兩者可以擇一或搭配。我們對這個指引相當有信心，且並不特別依賴製造產能。

Okay. Great. And then when we think about the development services revenue, how should we think about 2Q? Should -- I'm assuming there was none in Q1. Should we expect that to sequentially go up through the year?

了解。那再問一下，談到開發服務收入，我們該如何看待第二季？我猜第一季沒有。是否預期會在全年逐季上升？

Or should 2Q be perhaps a little bigger than that? Just trying to get a sense of that.

或者第二季可能就會比那樣更大一些？我想抓一下節奏。

So looking ahead, we expect revenue to be weighted towards the second half of 2026, primarily from government-related development services. We still have some revenue from development services in the first half, but it's relatively very low compared to the -- what we expect in the second half.

往前看，我們預期營收會偏向 2026 年下半年，主要來自政府相關的開發服務。上半年仍會有一些開發服務收入，但相對於我們預期下半年的規模，會非常低。

Don't forget that we still have an agreement with -- we have an agreement also with the Department of Force and Development Services there. So the assumption that it is 0 is not the right assumption. But definitely, it will be weighted towards the second half of the year.

別忘了，我們仍有一項協議——我們也與國防部（Department of Force）有協議，並在那裡提供開發服務。因此，假設是 0 並不正確。但可以確定的是，收入會偏向下半年。

Okay. And just one clarification. I thought I heard earlier in the remarks, you mentioned that the US manufacturing capacity expansion somehow hinged on the EU manufacturing capacity expansion. Did I hear that correct?

好的。再確認一點：我以為我先前在你們的說明中聽到，美國的製造產能擴充在某種程度上取決於歐盟的製造產能擴充。我有聽對嗎？

Because that would seem unusual that the two would be related, but I wanted to follow up on that.

因為這樣聽起來兩者有關聯有點不尋常，但我想追問確認一下。

Yeah, It's a technical constraint. Every product that is shipped from Israel -- from Israel to the United States needs to get an approval from the local agency. The local agency is considered the European one.

是的，這是一個技術性的限制。任何從以色列——從以色列運往美國的產品，都需要取得當地主管機關的核准。而這個當地主管機關被視為是歐洲那邊的機關。

So before I get the approval from the EMA or Israeli local agency, I cannot ship to the United States. But again, these are not different requirements. So I wouldn't spend too much in order to understand it. But it is what it is. We need to get OK clearance from Israel and then we can ship to the United States and then we can call for audits.

所以在我取得 EMA 或以色列當地主管機關的核准之前，我無法出貨到美國。但再次強調，這些並不是不同的要求，所以我不會花太多力氣去解讀它；但現況就是如此。我們需要先在以色列取得 OK 放行，之後才能出貨到美國，然後才能安排稽核。

Okay, great. Thank you for that clarification and thank you for taking the questions.

好的，了解。謝謝你釐清，也謝謝你們回答問題。

Thank you very much.

非常感謝。

Thank you. And that concludes our Q&A session. I'd like to turn the conference back over to management for any closing remarks.

謝謝。問答環節到此結束。接下來把電話會議交回管理層做結語。

So thank you, everyone, for joining us today. We look forward to updating you again on our next quarterly call.

謝謝各位今天參與。我們期待在下一次季度電話會議再向各位更新。

Thank you. That concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.

謝謝。今天的電話會議到此結束。我們感謝各位出席今天的簡報。各位現在可以掛線，祝各位有美好的一天。