Edap Tms SA (EDAP) 2025 Q1 法說會逐字稿

Good day. I would like to welcome everyone to Edap Tms first quarter 2025 earnings conference call.

再會。歡迎大家參加 Edap Tms 2025 年第一季財報電話會議。

(Operator Instructions)

（操作員指示）

I would now like to turn the call over to John Francis. Please go ahead.

現在我想把電話轉給約翰·弗朗西斯。請繼續。

Good morning.

早安.

Thank you for joining us for the Edap Tms first quarter 2025 Financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer Ken Mobi, Chief Financial Officer, and Francois Deach, Chief Accounting Officer.

感謝您參加 Edap Tms 2025 年第一季財務與經營績效電話會議。參加今天電話會議的還有執行長 Ryan Rhodes、財務長 Ken Mobi 和首席會計長 Francois Deach。

Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements, which includes statements regarding the company's growth and expansion plans.

在我們開始之前，我想提醒大家，管理階層今天的言論可能包含前瞻性陳述，其中包括有關公司成長和擴張計畫的陳述。

Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements.

此類聲明是基於管理階層目前的預期，並受多種風險和不確定因素的影響，可能導致實際結果與此類前瞻性聲明中所述的結果有重大差異。

Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission.

可能導致這種差異的因素包括但不限於公司向美國證券交易委員會提交的文件中所述的因素。

I would now like to turn the call over to Edap's Chief Executive Officer, Ryan Rhodes.

現在我想將電話轉給 Edap 的執行長 Ryan Rhodes。

Thank you, John, and good morning, everyone.

謝謝你，約翰，大家早安。

Over the last several months, Edap has made a series of important strategic decisions to further transform our company in becoming the global leader in Hai fu focal therapy.

在過去的幾個月裡，Edap 做出了一系列重要的策略決策，進一步轉型成為海扶療法的全球領導者。

In support of this strategy, we announced a series of important achievements which demonstrate the beginning of this transformation across multiple areas of our business. We placed nine focal one system in the first quarter of 2025, which is a record number of placements for any prior first quarter period.

為了支持這項策略，我們宣布了一系列重要成就，表明我們業務的多個領域已經開始了這項轉型。我們在 2025 年第一季安裝了 9 個焦點一系統，這是以往任何第一季中安裝數量的最高紀錄。

In March, we announced that Focal one received CE mark approval for the treatment of posterior deep infiltrating endometriosis. And in April, we launched the new focal 1I robotic HIFU system at this year's 2025 AUA meeting.

今年 3 月，我們宣布 Focal one 獲得 CE 標誌批准，可用於治療後部深部浸潤性子宮內膜異位症。今年 4 月，我們在今年 2025 年 AUA 會議上推出了新的焦點 1I 機器人 HIFU 系統。

As our focal one business continues to achieve these important milestones, we are also seeing a growing body of clinical data in support of robotic focal therapy for the management of prostate cancer.

隨著我們的重點業務不斷實現這些重要里程碑，我們也看到越來越多的臨床數據支持機器人局部治療用於治療前列腺癌。

Most notably, positive results from the FARC randomized controlled trial were presented at this year's 2025 AUA meeting, which we will discuss in more detail later on this call.

最值得注意的是，哥倫比亞革命武裝力量 (FARC) 隨機對照試驗的積極結果已在今年 2025 年 AUA 會議上公佈，我們將在稍後的電話會議上進行更詳細的討論。

Finally, we announced that Urologists from the Cleveland Clinic, Ohio, and the Cleveland Clinic Abu Dhabi conducted the world's first remote transatlantic focal one robotic hypo procedure.

最後，我們宣布來自俄亥俄州克利夫蘭診所和阿布達比克利夫蘭診所的泌尿科醫生進行了世界上首例遠端跨大西洋局部單一機器人低血壓手術。

A presentation discussing this groundbreaking procedure was to be delivered at this year's AUA meeting, and later on the call, I will provide additional details about this groundbreaking event.

今年的 AUA 會議上將進行一次關於​​這項突破性程序的演講，稍後在電話會議上，我將提供有關這一突破性事件的更多細節。

Collectively, these significant commercial regulatory and clinical milestones reflect our continued strategic focus on growing our core HIFU business and further validates the growing demand for focal one from the global Urology community. I will now discuss our system placement activity for the first quarter.

總的來說，這些重要的商業監管和臨床里程碑反映了我們持續致力於發展核心 HIFU 業務的戰略重點，並進一步驗證了全球泌尿外科界對焦點業務日益增長的需求。我現在將討論我們第一季的系統安置活動。

As noted, focal one continued along its positive growth trajectory in the first quarter of 2025.

如上所述，焦點一在 2025 年第一季繼續保持積極的成長軌跡。

We placed nine focal one robotic system in the quarter, which is a record number of system placements for any first quarter period in our company's history. The nine placements included six cash sales and three operating leases.

我們在本季安裝了九個焦點機器人系統，這是我們公司歷史上第一季安裝的系統數量的最高紀錄。九次配售包括六次現金銷售和三次營業租賃。

In the United States, our two cash sales were placed in Dallas, Texas, one with Baylor, Scott and White Health, and the second with Methodist Charlton Medical Center.

在美國，我們的兩筆現金銷售均在德克薩斯州達拉斯進行，一筆是與貝勒、斯科特和懷特健康中心進行的，另一筆是與衛理公會查爾頓醫療中心進行的。

Baylor, Scott and White Health is the largest nonprofit healthcare system in the state of Texas and ranks amongst the largest healthcare systems in the United States with nationally recognized medical services, including neurology.

貝勒、斯科特和懷特健康中心是德州最大的非營利醫療保健系統，也是美國最大的醫療保健系統之一，其醫療服務（包括神經病學）獲得全國認可。

Methodist Charlton Medical Center is part of the Methodist Health System, which has a network of 13 hospitals and more than 75 primary care and specialty clinics located throughout the region.

衛理公會查爾頓醫療中心是衛理公會醫療系統的一部分，該系統擁有遍布整個地區的 13 家醫院和 75 多家初級保健和專科診所組成的網路。

We believe the investment being made by such prominent community healthcare systems further reflects the growing recognition that focal one is fast becoming a medical necessary treatment option for prostate cancer patients.

我們相信，這些著名的社區醫療保健系統的投資進一步反映出人們日益認識到焦點醫療正迅速成為前列腺癌患者的必要治療選擇。

Importantly, both of these large healthcare systems operate in a very competitive environment within the fourth largest metropolitan statistical area in the United States, which represents another significant opportunity for Focal one to reach a large and important patient population.

重要的是，這兩個大型醫療保健系統都在美國第四大都市統計區內競爭非常激烈的環境中運營，這為 Focal one 接觸大量重要的患者群體提供了另一個重要機會。

We also signed individual 401 operating leases with three major hospital providers. These included Vanderbilt University of Colorado, and Kaiser Sacramento in Northern California.

我們也與三家主要醫院提供者簽署了單獨的 401 份經營租賃協議。其中包括科羅拉多范德比爾特大學和北加州的凱撒薩克拉門託大學。

Both Vanderbilt University and the University of Colorado are members of the National Comprehensive Cancer Network or NCCN, which is an alliance of 33 of the leading US hospital cancer centers devoted to patient care, research and education.

范德堡大學和科羅拉多大學都是美國國家綜合癌症網絡（NCCN）的成員，該網絡是由 33 家美國領先的醫院癌症中心組成的聯盟，致力於患者護理、研究和教育。

I am pleased to note that over half of these NCCN member institutions now have access to our focal one robotic HIFU platform.

我很高興地註意到，超過一半的 NCCN 成員機構現在可以使用我們的焦點機器人 HIFU 平台。

In addition, the University of Colorado also has an active Society of Neurologic oncology SUO fellowship program.

此外，科羅拉多大學還設有活躍的神經腫瘤學會 SUO 獎學金計畫。

By establishing a focal one training program within these highly regarded prestigious institutions, we can train the next generation of leading neurologists to become proficient in the use of robotic focal therapy to manage their prostate cancer patients.

透過在這些備受推崇的著名機構內建立焦點培訓計劃，我們可以培訓下一代領先的神經科醫生，使他們能夠熟練地使用機器人局部治療來治療前列腺癌患者。

Our placement with Kaiser Permanente Sacramento is also notable as this is our second placement within this large and influential healthcare network.

我們與 Kaiser Permanente Sacramento 的合作也值得關注，因為這是我們第二次與這個龐大且有影響力的醫療保健網絡合作。

Kaiser is one of America's leading healthcare providers and nonprofit health plans serving approximately €12.4 million people.

凱撒是美國領先的醫療保健提供者和非營利健康計劃之一，為約 1240 萬人提供服務。

We are highly encouraged to see a growing number of focal one systems being placed within these larger healthcare networks, and we anticipate this positive trend continuing throughout 2025 and beyond.

我們非常高興地看到，越來越多的焦點系統被納入這些更大的醫療保健網絡，我們預計這一積極趨勢將持續到 2025 年及以後。

Our Pokémon business in the international markets also continues to gather momentum.

我們的 Pokémon 業務在國際市場上也持續蓬勃發展。

In the first quarter, we completed 4 cash sales of Focal one outside of the United States, which included system placements throughout Europe, the Middle East, and Asia.

第一季度，我們在美國以外完成了 4 筆 Focal one 的現金銷售，其中包括遍布歐洲、中東和亞洲的系統部署。

I will now briefly touch on some key financial and operating metrics for the first quarter of 2025. We reported Hai fu revenues of €6.2 million as compared to €5.8 million for the first quarter of 2024, up 6.8% on a year over year basis.

現在我將簡要介紹2025年第一季的一些關鍵財務和營運指標。我們報告稱，海富的營收為 620 萬歐元，而 2024 年第一季的營收為 580 萬歐元，年成長 6.8%。

Total worldwide revenue was €13.6 million a decrease of 9.1% as compared to total revenue of €14.9 million for the same period in 2024.

全球總收入為 1,360 萬歐元，與 2024 年同期的總收入 1,490 萬歐元相比下降了 9.1%。

As noted on our fourth quarter conference call. The decline in non-core revenue was expected based on the strategic decision to focus exclusively on our high growth opportunity to become the global leader in focal therapy with our focal one robotic HIFU platform.

正如我們第四季電話會議所指出的那樣。非核心收入的下降是基於我們的策略決策而預期的，即專注於我們的高成長機會，利用我們的焦點機器人 HIFU 平台成為局部治療領域的全球領導者。

During the first quarter, US procedures grew approximately 4% over the first quarter of 2024, while the demand for focal one amongst the US urology community continues to remain strong. Over the last few months, we have experienced longer and more challenging review and procedure approvals, especially for patients enrolled in Medicare Advantage plans.

第一季度，美國的手術量比 2024 年第一季成長了約 4%，而美國泌尿外科界對焦點手術的需求持續強勁。在過去的幾個月裡，我們經歷了更長、更具挑戰性的審查和程序審批，特別是對於參加醫療保險優勢計劃的患者。

To be clear, this appears to be an industry-wide issue, and not one specific to folk one HIFU therapy. We continue to work diligently with our partners to increase market access and help accelerate pre-authorizations for focal one HIFI procedures.

需要明確的是，這似乎是整個產業的問題，而不是民間 HIFU 治療所特有的問題。我們將繼續與合作夥伴密切合作，以擴大市場准入並協助加快焦點一 HIFI 程序的預先授權。

The recently published HIFI study continues to be instrumental in this process and has already begun to make a positive impact.

最近發表的 HIFI 研究繼續在這一過程中發揮重要作用，並且已經開始產生積極影響。

As previously discussed last quarter, we believe the recent publication of the Landmark HIFI study in European neurology will help drive additional focal one adoption and procedure growth.

正如上個季度所討論的那樣，我們相信最近發表的歐洲神經病學里程碑 HIFI 研究將有助於推動更多焦點的採用和程序的成長。

To learn more about this compelling clinical evidence from this landmark study, I would encourage you to visit the website hifistudy.com, which provides an excellent, easy to understand summary of the clinical data.

要了解這項具有里程碑意義的研究的更多令人信服的臨床證據，我建議您訪問網站 hifistudy.com，該網站提供了出色且易於理解的臨床數據摘要。

I will now provide a brief update on our clinical programs.

我現在將簡要介紹我們的臨床項目的最新情況。

In March, we announced that Focal one robotic HIFI received CE mark indication for the treatment of deep infiltrating endometriosis.

今年3月，我們宣布Focal one機器人HIFI獲得CE標誌，可用於治療深部浸潤性子宮內膜異位症。

As a reminder, deep infiltrating endometriosis is a severe chronic inflammatory disease affecting young women of reproductive age and is also recognized as the most aggressive form of this disease.

需要提醒的是，深部浸潤性子宮內膜異位症是一種影響育齡年輕女性的嚴重慢性發炎性疾病，也被認為是這種疾病最具侵襲性的形式。

Receiving this CE mark from the European Union notified body represents a significant regulatory milestone enabling us to proceed with a controlled market entry while we continue to work with endometriosis experts and thought leaders to further refine and expand our clinical development efforts for addressing this disease.

獲得歐盟公告機構頒發的 CE 標誌代表著一個重要的監管里程碑，使我們能夠以可控的方式進入市場，同時我們將繼續與子宮內膜異位症專家和思想領袖合作，進一步完善和擴大我們治療這種疾病的臨床開發工作。

We also believe this milestone represents the first step in enabling women to gain access to this important non-invasive treatment alternative to surgical intervention. Which is associated with notable complications, side effects, and extended recovery times.

我們也相信，這個里程碑代表著讓女性獲得這種重要的非侵入性手術介入替代治療方法的第一步。這會導致明顯的併發症、副作用和延長恢復時間。

I would now like to briefly discuss some of our recent strategic collaborative activities. As noted earlier, we recently announced the world's first remote transatlantic focal one robotic HIFU procedure.

現在我想簡單談談我們最近的一些策略合作活動。如前所述，我們最近宣布了世界上第一個遠端跨大西洋焦點機器人 HIFU 手術。

This landmark procedure was performed across the distance of over 7,000 miles between two globally recognized Cleveland Clinic hospitals.

這項具有里程碑意義的手術是在兩家全球知名的克利夫蘭診所醫院之間進行的，相距超過 7,000 英里。

Using EAP's leading focal one robotic HIFU system, Urologist Dr. Walid Hassan in Cleveland Clinic, Abu Dhabi, managed the patient in the operating room locally while urologist Dr. Ruben Olivares in Cleveland Clinic, Ohio connected remotely to the focal one system in Abu Dhabi through an EDA developed proprietary workstation.

使用 EAP 領先的 focal one 機器人 HIFU 系統，阿布達比克利夫蘭診所的泌尿科醫生 Walid Hassan 博士在當地手術室對患者進行管理，而俄亥俄州克利夫蘭診所的泌尿科醫生 Ruben Olivares 博士則透過 EDA 開發的專有工作站遠端連接到阿布達比的 focal one 系統。

Doctor Olivers thus controlled the focal one system in real time from Ohio and collaborated with Doctor Hassen in Abu Dhabi to perform the procedure on the patient.

因此，奧利佛醫師從俄亥俄州即時控制了焦點一號系統，並與阿布達比的哈森醫生合作對患者實施了手術。

This event represents an important clinical and technological milestone in the treatment of prostate cancer for the focal One platform, and we would like to congratulate the entire Cleveland Clinic team on this historic event.

這項活動代表了 Focus One 平台在前列腺癌治療領域的一個重要的臨床和技術里程碑，我們想祝賀整個克利夫蘭診所團隊取得這一歷史性成就。

We believe this achievement will serve as a first step in a series of continued innovations that will further position focal One as a leading platform for focal therapy.

我們相信，這項成就將成為一系列持續創新的第一步，進一步使 focal One 成為焦點治療的領先平台。

Longer term, we anticipate remote procedure capabilities will facilitate more efficient and effective training and mentoring of surgeons on focal one with the ability to broaden patient access to expert care.

從長遠來看，我們預計遠距手術能力將有利於對焦點外科醫生進行更有效的培訓和指導，並能夠擴大患者獲得專家護理的機會。

Voel's reputation continues to grow as being the most compatible, scalable, and sought after technology platform for focal therapy, and we continue to expect additional collaborations in the future as we expand our presence in the management of prostate cancer and into other potential new indications.

Voel 作為局部治療領域最相容、可擴展且最受歡迎的技術平台，其聲譽不斷提升，隨著我們在前列腺癌管理領域和其他潛在新適應症領域的拓展，我們期待未來有更多合作。

I would now like to discuss our recent scientific conference activity. Ahead of this year's recent American Neurological Association meeting, the AUA, we partnered with leading academic urology team from the University of Southern California to hold the first ever master class on robotic focal HIFU for prostate cancer.

現在我想討論一下我們最近的科學會議活動。在今年最近的美國神經病學協會 (AUA) 會議之前，我們與南加州大學領先的泌尿科學術團隊合作，舉辦了第一屆機器人焦點 HIFU 治療前列腺癌大師班。

This event took place on April 24 and 25 in Los Angeles, two days in advance of this year's AUA meeting. The event was extremely well attended, attracting approximately 100 neurologists from 14 countries around the world.

該活動於4月24日至25日在洛杉磯舉行，比今年的AUA會議提前兩天。這次活動參與人數眾多，吸引了來自全球 14 個國家的約 100 名神經病學家。

Edap was the sole sponsor of this event, and Focal One was the exclusive technology presented throughout the program.

Edap 是本次活動的獨家贊助商，而 Focal One 是整個活動期間展示的獨家技術。

The robotic focal HIFI masterclass was led by world renowned faculty and featured several live focal one procedures while offering hands-on focal one simulation sessions for attendees.

機器人焦點 HIFI 大師班由世界知名教師主持，並展示了幾個現場焦點一程序，同時為與會者提供動手焦點一模擬課程。

Moving on to the important AUA meeting this year, we had our largest presence ever. As the AUA is the largest meeting in the world focused on neurology, and a significant number of presentations were made that highlighted the growing body of clinical data that is being generated from focal I HIFI procedures.

今年我們參加了重要的 AUA 會議，這是有史以​​來我們參加人數最多的一次。由於 AUA 是世界上規模最大的神經病學會議，因此大量的演講都強調了從局部 I HIFI 程序中產生的越來越多的臨床數據。

Of particular importance results from the much-anticipated FARP randomized controlled trial were presented at this year's meeting.

尤其重要的是，備受期待的 FARP 隨機對照試驗的結果在今年的會議上公佈。

This level one evidence study achieved its primary endpoint and demonstrated that the rate of treatment failure in the focal ablation group is non inferior to that in the radical prostatectomy group at the final three year follow up.

這項一級證據研究達到了其主要終點，並證明在最後三年的追蹤中，局部消融組的治療失敗率並不低於根治性攝護腺切除術組。

A total of 213 patients were enrolled in the study with 107 patients randomized to receive focal ablation and 106 to undergo radical prostatectomy.

共有 213 名患者參與了這項研究，其中 107 名患者隨機接受局部消融術，106 名患者接受根治性前列腺切除術。

Results from the study showed that the proportion of treatment failure was 6.5% in the focal ablation group, which was lower compared to the 8.5% in the radical prostatectomy group.

研究結果顯示，局部消融組的治療失敗率為 6.5%，低於根治性攝護腺切除術組的 8.5%。

As a randomized controlled trial, the FARP study represents the first level one evidence in support of high food therapy and mirrors the positive outcomes observed from larger landmark HIFI study, which also showed that HIFU therapy was not inferior to radical prostatectomy.

作為一項隨機對照試驗，FARP 研究代表了支持高食物療法的第一個一級證據，並反映了更大規模、具有里程碑意義的 HIFI 研究觀察到的積極結果，該研究也表明 HIFU 治療並不劣於根治性前列腺切除術。

We believe the cumulative impact from these rigorous data sets all point towards increased adoption of focal therapy for addressing early-stage prostate cancer, and we anticipate a growing number of clinical studies showing the benefits of focal I will continue to emerge in the major scientific meetings that focus on both urology and prostate cancer.

我們相信，這些嚴格的數據集的累積影響都表明，局部治療在治療早期前列腺癌方面的應用將會增加，並且我們預計，在關注泌尿科和前列腺癌的主要科學會議上，將會有越來越多的臨床研究顯示局部治療的益處。

In addition, this growing body of medical evidence will be instrumental in further advancing discussions on prostate cancer. And treatment guidelines and in possibly shaping coverage policies among healthcare insurance carriers. Another major announcement for the company was the launch of the new Focal one.

此外，越來越多的醫學證據將有助於進一步推進有關前列腺癌的討論。以及治療指南，並可能製定醫療保險業者的承保政策。該公司的另一個重大公告是推出新款 Focal。

I Robotic hauls system at this year's AUA. Focal one I represent a significant advancement. To our leading robotic HIFU platform that incorporates a number of cutting-edge technology advancements.

我在今年的 AUA 上展示了機器人運輸系統。焦點一 I 代表著一項重大進步。我們的領先機器人 HIFU 平台融合了多項尖端技術進步。

These include additional cap compatibility with the latest diagnostic imaging modalities, AI-based algorithms, along with remote procedure and collaboration cap capabilities.

這些包括與最新診斷成像模式的額外相容性、基於人工智慧的演算法，以及遠端程式和協作帽功能。

The new design of the focal One eye system, along with these additional features are based directly on the feedback of our customers, as well as anticipating the future needs of surgeons performing focal therapy.

焦點單眼系統的新設計以及這些附加功能直接基於我們客戶的回饋，並預測了進行局部治療的外科醫生的未來需求。

I will now turn the call over to Ken, who will review our first quarter 2025 financial results and also touch upon potential implications from recent US tariff activity.

現在我將電話轉給肯，他將回顧我們 2025 年第一季的財務業績，並談及近期美國關稅活動的潛在影響。

Thank you, Ryan, and good morning, everyone. For conversion purposes, our average EURO to dollar exchange rate was €1.05 for the first quarter of 2025.

謝謝你，瑞安，大家早安。為了換算，2025 年第一季歐元兌美元的平均匯率為 1.05 歐元。

Total HIFU revenue for the first quarter of 2025 was €6.2 million an increase of 6.8% as compared to €5.8 million for the first quarter of 2024.

2025 年第一季 HIFU 總營收為 620 萬歐元，與 2024 年第一季的 580 萬歐元相比成長 6.8%。

The increase in revenue was driven by six Focal one system sold in the first quarter of 2025 versus five systems sold in the first quarter of 2024, as well as increases in service-related revenue.

營收的成長得益於 2025 年第一季銷售了 6 套 Focal one 系統（2024 年第一季銷售了 5 套系統）以及服務相關收入的增加。

Total worldwide revenue for the first quarter of 2025 was €13.6 million a decrease of 9.1% as compared to total revenue of €14.9 million for the same period in 2024. The decrease in revenue was due to declines of 23.8% and 17.5% in our non-core ESWL and distribution divisions respectively.

2025 年第一季全球總營收為 1,360 萬歐元，與 2024 年同期的 1,490 萬歐元總營收相比下降了 9.1%。收入減少是由於我們的非核心 ESWL 和分銷部門分別下降了 23.8% 和 17.5%。

As we discussed on our fourth quarter of 2024 conference call, we expect revenue declines in our non-core segments between 20% and 25% from 2024 levels as we focus on becoming a pure play market leader in therapeutic HIFU.

正如我們在 2024 年第四季電話會議上所討論的那樣，我們預計非核心部門的收入將比 2024 年的水準下降 20% 至 25%，因為我們專注於成為治療性 HIFU 領域的純市場領導者。

Gross profit for the first quarter of 2025 was €5.7 million compared to €6.4 million for the same period in 2024. Gross profit margin was 42% in the first quarter of 2025 compared to 42.8% in the year ago period.

2025 年第一季的毛利為 570 萬歐元，而 2024 年同期的毛利為 640 萬歐元。2025 年第一季毛利率為 42%，去年同期為 42.8%。

The decrease in gross profit margin year over year was primarily due to mixed changes within our product portfolio.

毛利率年減主要是由於我們的產品組合發生混合變化。

Operating expenses were €11.7 million for the first quarter of 2025 compared to €11.2 million for the same period in 2024. The increase in operating expenses was primarily due to focused investments in our Hau business segment.

2025 年第一季的營運費用為 1,170 萬歐元，而 2024 年同期為 1,120 萬歐元。營業費用的增加主要是由於我們對 Hau 業務部門的重點投資。

Operating loss for the first quarter of 2025 was €6 million compared to an operating loss of €4.8 million in the first quarter of 2024, including the impact of non-cash share-based compensation, operating loss for the first quarter would have been €5.7 million compared to an operating loss of €4.1 million in quarter one 2024.

2025 年第一季的營業虧損為 600 萬歐元，而 2024 年第一季的營業虧損為 480 萬歐元，如果包括非現金股權激勵的影響，則第一季的營業虧損為 570 萬歐元，而 2024 年第一季的營業虧損為 410 萬歐元。

Net loss for the first quarter of 2025 was €7.1 million or €0.19 per diluted share as compared to a net loss of €4.5 million or €0.12 per diluted share in the year ago period. Inventory decreased to €1818 million at the end of quarter one 2025 as compared to €18.5 million at the end of quarter four 24.

2025 年第一季淨虧損為 710 萬歐元，即每股攤薄虧損 0.19 歐元，而去年同期淨虧損為 450 萬歐元，即每股攤薄虧損 0.12 歐元。2025 年第一季末，庫存下降至 18.18 億歐元，而 2024 年第四季末則為 1850 萬歐元。

The decrease in inventory levels was due to our ongoing efforts to effectively balance our demand and supply base along with more efficient just in time inventory management with our distribution partners. Total cash and cash equivalent at the end of quarter one was €22.8 million as compared to €29.8 million at the end of quarter four 2024. The decrease was driven primarily by the cash used in operating activities.

庫存水準的下降是由於我們不斷努力有效地平衡需求和供應基礎，以及與分銷合作夥伴更有效率的準時庫存管理。第一季末的現金及現金等價物總額為 2,280 萬歐元，而 2024 年第四季末的現金及現金等價物總額為 2,980 萬歐元。下降的主要原因是經營活動所用的現金。

Respect to the ongoing changes in tariff policies, there was no impact to our first quarter results. However, based on our latest estimates, we are currently forecasting a 10% tariff impact for all goods transferred from France to the US for the second quarter.

儘管關稅政策正在發生變化，但這對我們的第一季業績沒有影響。然而，根據我們最新的估計，我們目前預測第二季從法國輸往美國的所有商品的關稅影響將達到 10%。

As previously noted, approximately 80% to 90% of our Focal one component come from France, along with 100% of the Focal one system being assembled in France.

如前所述，我們大約 80% 到 90% 的 Focal one 組件來自法國，並且 100% 的 Focal one 系統都在法國組裝。

We will continue to monitor the potential impact from the Trump administration's tariff policies and adjust our forecasts accordingly.

我們將繼續關注川普政府關稅政策的潛在影響，並據此調整我們的預測。

We continue to monitor our cash flow closely, focusing on working capital management while actively balancing the need to invest and grow our HIFU business. Based on our strategic focus in growing our focal one business, we are currently considering a broad range of potential financing options that will strengthen our balance sheet and support our market leading position in therapeutic HIFU.

我們繼續密切監控現金流，專注於營運資金管理，同時積極平衡投資和發展 HIFU 業務的需求。基於我們發展重點業務的策略重點，我們目前正在考慮廣泛的潛在融資選擇，以加強我們的資產負債表並支持我們在治療性 HIFU 領域的市場領先地位。

I would like to now turn the call back to Ryan for closing comments.

現在我想將電話轉回給 Ryan 來做最後評論。

Thanks, Ken. With respect to guidance, we are reiterating the 2025 revenue guidance which we first issued on our fourth quarter call in late March.

謝謝，肯。關於指引，我們重申我們在 3 月底第四季電話會議上首次發布的 2025 年收入指引。

We continue to expect HIFU revenue to grow between 16% and 25% on a year over year basis, and the non-core ESWL distribution businesses to decline between 20% and 25% on a year over year basis.

我們繼續預期 HIFU 營收將年增 16% 至 25%，而非核心 ESWL 分銷業務將年減 20% 至 25%。

In summary, we continue to focus on our strategic plan in becoming the global leader in focal therapy, and our recent positive announcements demonstrate that we are making progress towards achieving these goals.

總之，我們繼續專注於我們的策略計劃，成為局部治療領域的全球領導者，我們最近的積極公告表明我們正在朝著實現這些目標的方向前進。

Demand for our leading Focal one platform remains on a strong upward trajectory, and we believe the introduction of the new Focal one eye system will further strengthen EAP's technological leadership in focal therapy.

我們領先的 Focal one 平台的需求仍保持強勁上升趨勢，我們相信新的 Focal one 眼系統的推出將進一步加強 EAP 在局部治療方面的技術領先地位。

As we continue to bring innovation and cutting-edge technology to the focal one platform, a growing body of clinical data provides additional evidence that supports the use of focal therapy for prostate cancer.

隨著我們不斷將創新和尖端技術引入焦點平台，越來越多的臨床數據提供了更多證據，支持使用局部療法治療前列腺癌。

We believe the positive results from the landmark HIFI study.

我們相信具有里程碑意義的 HIFI 研究將帶來正面成果。

Coupled with the recent presentation of the FARC randomized clinical trial data at this year's AUA will accelerate the adoption of focal therapy across the global com Urology community.

再加上今年 AUA 上最近展示的 FARC 隨機臨床試驗數據，將加速全球泌尿外科界對局部治療的採用。

These studies reinforce the oncologic efficacy of focal one and support the favorable quality of life functional outcomes patients are demanding.

這些研究強化了局部治療的腫瘤學療效，並支持了患者所要求的良好生活品質功能結果。

As focal one is a non-surgical, non-invasive procedure that requires no cutting, no blood loss, and no use of radiation. Finally, when we step back and look at the number of focal one placement since the beginning of 2022. We are clearly experiencing the steady upward trend in demand that we believe will continue to gain momentum.

其中最主要的是非手術、非侵入性手術，無需切割、不失血、不使用放射線。最後，我們回顧一下自 2022 年初以來的焦點一號安置數量。我們顯然正在經歷需求的穩定上升趨勢，我們相信這種趨勢將繼續增強。

As noted, we placed a record number of Focal one system in the first quarter, and we are seeing growing interest in the Focal One platform from many of the large hospital networks. These are clearly positive signs of focal one adoption, and we expect this trend will continue in 2025 and beyond.

如上所述，我們在第一季安裝了創紀錄數量的 Focal One 系統，並且我們看到許多大型醫院網路對 Focal One 平台的興趣日益濃厚。這些顯然是採用焦點一的正面訊號，我們預計這一趨勢將在 2025 年及以後持續下去。

With that, I will now turn the call back over to the operator for questions.

說完這些，我現在將把電話轉回給接線員以回答問題。

Thank you, sir.

謝謝您，先生。

(Operator Instructions)

（操作員指示）

We'll go for our first question for Michael Sarcone with Jeffreys. Please go ahead.

我們的第一個問題將問 Jeffreys 的 Michael Sarcone。請繼續。

Good morning and thanks for taking our questions. Just to start, Ryan, you commented on, some maybe changing trends on the payer landscape longer and more challenging reviews and procedure approvals. Maybe, can you just elaborate some more here, when exactly did you start seeing this?

早安，感謝您回答我們的問題。首先，瑞安，您評論說，付款人格局的一些變化趨勢可能是更長、更具挑戰性的審查和程序批准。也許，您能否在這裡詳細說明一下，您究竟是什麼時候開始看到這種情況的？

Is it only in the Medicare Advantage population or are you seeing that starting to broaden out just trying to get a better sense of what's going on here?

這是否僅限於醫療保險優勢人群，還是您是否看到這種情況開始擴大，只是想更了解這裡發生的事情？

Yeah, the comments and trends that I referenced are relevant to the Medicare Advantage Plan patients. As noted, about approximately 54% of patients who are on a Medicare plan will opt for a Medicare Advantage plan or a Medicare Part C plan.

是的，我引用的評論和趨勢與醫療保險優勢計劃患者相關。如上所述，大約 54% 的醫療保險計劃患者會選擇醫療保險優勢計劃或醫療保險 C 部分計劃。

We continue to work closely through this process. We're working with one of the largest and most capable consulting firms, and reimbursement and market access has been a core competency for the company, and we continue to see significant progress.

我們將繼續在這過程中密切合作。我們正在與規模最大、能力最強的諮詢公司之一合作，報銷和市場准入一直是該公司的核心競爭力，我們不斷看到顯著的進展。

And we continue to work through that process with individual payers and certainly with patients. So again, it's as referenced really in the area of Medicare Advantage that I made common to.

我們將繼續與個人付款人以及患者一起完成此流程。所以，正如我在醫療保險優勢計劃 (Medicare Advantage) 領域所提到的那樣。

Got it. I see. And so, is that has that continued, into two and are you ultimately able to get, the procedure approved? It just takes longer or are you seeing, any portion of these processes end up, in denial?

知道了。我懂了。那麼，這種情況會持續下去嗎？分為兩步嗎？最終您能獲得程序批准嗎？這只不過是需要更長的時間，還是說您是否看到這些過程的任何部分最終都以拒絕告終？

Well, there's always the risk of some denials, but we show notable progress of appeals and working through that progress or process with, and we see more patients obviously winning on the appeal front. So again, we stay very active in the process.

嗯，總是存在一些被拒絕的風險，但我們在上訴方面取得了顯著進展，並且正在努力完成這一進展或流程，我們看到更多患者在上訴方面明顯獲勝。因此，我們在過程中保持非常活躍的狀態。

We work very closely with the individual institutions, and we monitor it through use of our outside consulting partners. So, again, we, as mentioned, we see obviously more appeals happening, but we win in the majority of these appeals.

我們與各個機構密切合作，並透過外部諮詢合作夥伴進行監控。因此，正如我們所提到的，我們顯然看到有更多的上訴發生，但我們在大多數上訴中都獲勝了。

Got it. That's helpful. Maybe last one for me, maybe for Ken, you've maintained your HIFU sales growth guidance of 16% to 25%. Would love to just get a sense for what's incorporated into those assumptions at the low end and the high end and are you incorporating, a meaningful acceleration in procedure growth?

知道了。這很有幫助。對我來說也許這是最後一個，對 Ken 來說也許也是最後一個，您一直保持著 16% 至 25% 的 HIFU 銷售成長預期。很想了解在低端和高端的假設中都包含了哪些內容，以及您是否將其納入到程式成長的有意義的加速中？

I think you said high food procedure growth, 4%. Are we assuming in the guide that you know these payers, challenges, recede and you get an acceleration in two each?

我認為您說的是食品加工成長率高，4%。我們是否在指南中假設您了解這些付款人、挑戰、消退，並且您在兩者中都獲得了加速？

Yeah, so great question.

是的，這個問題問得真好。

Thank you, Michael. So, as capital equipment environment is lumpy. We're holding guidance, right now, we do have, procedure growth. A factored in our forecast right now and where we see the business at this phase, we're still, confident that we will achieve in that range between 16% to 25% HIFU revenue growth for the year.

謝謝你，麥可。因此，資本設備環境不穩定。我們目前正持有指導意見，我們確實有程序增長。考慮到我們目前的預測以及我們對現階段業務的了解，我們仍然有信心，今年的 HIFU 收入成長率將在 16% 到 25% 之間。

Got it thank you Ken.

明白了，謝謝你，肯。

Will next go to Sean Lee with HC Wainwright.

接下來將與 HC Wainwright 一起前往 Sean Lee。

Hey, good morning, guys, and thanks for taking my questions. I just have a couple on the endometriosis front. So, with the reception, the CE mark approval, what are your next steps on marketing, focal one for endometriosis in Europe?

嘿，大家早安，感謝你們回答我的問題。我剛剛患上子宮內膜異位症。那麼，在獲得 CE 標誌批准後，您在行銷方面的下一步計劃是什麼，重點是針對歐洲的子宮內膜異位症？

And also, maybe just a follow up to that. What are your plans for, endometriosis in the US? Thanks.

而且，也許只是對此的跟進。您對美國子宮內膜異位症治療有何計畫？謝謝。

Yeah, as referenced, we have embarked on a controlled market entry in CE countries, so we're working with a small group of initial hospitals based on receiving CE approval. And so again, our goal there is to continue to work with those thought leaders and really expand the clinical development efforts.

是的，正如所提到的，我們已經開始在 CE 國家進行受控市場准入，因此我們正在與一小部分獲得 CE 批准的初始醫院合作。因此，我們的目標是繼續與這些思想領袖合作，真正擴大臨床開發力道。

In preparation for a broader launch among CE countries, so it's kind of a stepwise approach. We're in this first phase and then we'll move to a secondary phase.

為了準備在中歐國家中更廣泛地推出，這是一種逐步的方法。我們正處於第一階段，然後我們將進入第二階段。

In terms of the US, again, we're what we're doing now is remember we're following up on the random randomized control trial, the phase two study, our phase two study and phase three studies.

就美國而言，我們現在正在做的事情是記住我們正在跟進隨機對照試驗、第二階段研究、我們的第二階段研究和第三階段研究。

In order to continue to track that data set and monitor those patients, as we've communicated in the past, there was a high number of patients post the randomized controlled trial that opted to Have focal one ablation for their endometriosis.

為了繼續追蹤該數據集並監測這些患者，正如我們過去所傳達的那樣，在隨機對照試驗後，有大量患者選擇進行局部消融治療子宮內膜異位症。

So, we want to be able to use that data and carry that data set forward for future interactions with the FDA in the US, but in the interim we're working in this controlled launch phase in Europe with our recent CE mark approval.

因此，我們希望能夠使用這些數據並將該數據集用於未來與美國 FDA 的互動，但在此期間，我們正在歐洲根據最近獲得的 CE 標誌批准開展這一受控發布階段的工作。

That's very helpful. Well thanks for that.

這非常有幫助。好的，謝謝。

And at this time we have no further questions. I'd like to turn the call back over to Ryan Rhodes for final and closing remarks.

目前我們沒有其他問題。我想將電話轉回給 Ryan Rhodes 做最後的總結發言。

I want to thank everyone for joining us on today's call, and we look forward to seeing you at the upcoming Jeffrey's Global Healthcare Conference on Thursday, June 5 in New York City.

我要感謝大家參加今天的電話會議，我們期待在 6 月 5 日星期四於紐約舉行的 Jeffrey 全球醫療保健會議上見到您。

Thank you.

謝謝。

Thank you and ladies and gentlemen that does conclude today's pro program we thank you for your participation. You may disconnect at any time.

謝謝大家，女士們，先生們，今天的專業節目到此結束，謝謝你們的參與。您可以隨時斷開連線。