Edap Tms SA (FOCL) 2026 Q1 法說會逐字稿

(Operator Instructions)

(接線員指示)

Greetings, and welcome to the EDAP TMS First Quarter 2026 Conference Call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Louisa Smith from Gilmartin Group. Please go ahead.

各位早安，歡迎參加 EDAP TMS 2026 年第一季電話法說會。提醒各位，本次電話會議將進行錄音。現在我想把電話交給來自 Gilmartin Group 的 Louisa Smith。請開始。

Good morning. Thank you for joining us for the EDAP TMS First Quarter 2026 Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer; Ken Mobeck, Chief Financial Officer; and Francois Dietsch, Chief Accounting Officer.

各位早安。感謝各位參加 EDAP TMS 2026 年第一季財務與營運成果電話法說會。今天與我一同出席的有執行長 Ryan Rhodes、財務長 Ken Mobeck，以及會計長 Francois Dietsch。

Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

在開始之前，我想提醒各位，管理層今天的發言可能包含《1995 年私人證券訴訟改革法》所定義的前瞻性陳述。

These forward-looking statements are based on management's current expectations and involve risks and uncertainties that could cause actual results to differ materially from those anticipated.

這些前瞻性陳述係基於管理層目前的預期，並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。

We direct you to the Risk Factors section of our most recently filed annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission as well as our other filings with the SEC for a description of factors that may cause such differences.

我們請各位參閱我們最近提交的截至 2025 年 12 月 31 日止年度 Form 10-K 年報中「風險因素」章節（已向美國證券交易委員會提交），以及我們向 SEC 提交的其他文件，其中描述了可能造成此類差異的因素。

These statements speak only as of today's date, and we undertake no obligation to update or revise them, except as required by law. Additionally, this call is being recorded and constitutes a public disclosure for purposes of Regulation FD.

上述陳述僅截至今日有效；除法律要求外，我們不承擔更新或修訂之義務。此外，本次電話會議將進行錄音，並就 Regulation FD 而言構成公開揭露。

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

現在我想把電話交給執行長 Ryan Rhodes。

Thank you, Louisa, and good morning, everyone. As announced this morning, we delivered a strong first quarter.

謝謝你，Louisa，各位早安。如同今天早上所公布的，我們交出強勁的第一季表現。

We reported record first quarter total revenue for the company of $17.8 million, led by record first quarter Focal One Robotic HIFU revenue of $11.6 million, further reinforcing the momentum we highlighted on our previous fourth quarter call.

我們第一季公司總營收達到創新高的 1,780 萬美元，其中 Focal One 機器人 HIFU 第一季營收亦創新高，達 1,160 萬美元，進一步強化我們在上一季第四季電話會議中所提到的動能。

Today, I will provide additional color on new system placements, growing utilization trends and our ongoing indication expansion efforts before turning the call over to Ken to review our financial results.

今天，在把電話交給 Ken 說明財務結果之前，我將就新系統裝機、使用量成長趨勢，以及我們持續推動適應症擴展的工作提供更多說明。

Before discussing the quarter in more detail, I would like to remind everyone that effective January 1 of this year, EDAP becomes a US domestic issuer. As a result, beginning this quarter, we will report all financial results in US dollars on a go-forward basis.

在更詳細討論本季之前，我想提醒各位，自今年 1 月 1 日起，EDAP 成為美國本土發行人。因此，自本季起，我們將在未來以美元呈報所有財務結果。

Now turning to our first quarter results.

接著談我們第一季的結果。

Our HIFU business continues to demonstrate strong and sustained momentum. We have now delivered seven consecutive quarters of year-over-year growth in this segment, reflecting increasing physician adoption, expanding utilization and growing global demand for Focal One Robotic HIFU technology.

我們的 HIFU 業務持續展現強勁且可持續的動能。目前我們在此分部已連續七個季度實現年對年成長，反映醫師採用度提升、使用量擴大，以及全球對 Focal One 機器人 HIFU 技術需求增加。

We delivered record revenue across our core HIFU business driven by strong growth in both system placements and procedure volumes across US and international markets. During the quarter, we recorded 11 capital sales and 10 total net placements, further reinforcing the strength and growing visibility of our Focal One pipeline.

在美國與國際市場的系統裝機與手術量雙雙強勁成長帶動下，我們核心 HIFU 業務營收創下新高。本季我們記錄了 11 台資本設備銷售與 10 台淨裝機，進一步印證我們 Focal One 管線的強勁力道與能見度提升。

In the quarter, we continued to expand adoption across many of the most prestigious academic cancer centers in the United States.

本季我們持續在美國多家最具聲望的學術型癌症中心擴大採用。

As noted, University of Pittsburgh Medical Center, UPMC, converted to a cash sale and Moffitt Cancer Center became the 10th Focal One system installed in the state of Florida. These placements further validate Focal One's emergence as a leading robotic focal therapy platform being adopted and utilized by top-ranked institutions nationwide.

如前所述，匹茲堡大學醫學中心（UPMC）轉為現金銷售，而 Moffitt 癌症中心則成為佛羅里達州安裝的第 10 套 Focal One 系統。這些裝機進一步驗證 Focal One 正崛起為領先的機器人局部治療平台，並被全國頂尖機構採用與使用。

We also placed a second Focal One system within the Mass General Brigham Healthcare Network. With this addition, 11 US hospital and health networks have now invested in and launched two or more Focal One robotic HIFU programs, underscoring the growing utilization, confidence and long-term commitment we are seeing from major health care systems.

我們也在 Mass General Brigham 醫療網絡內部署了第二套 Focal One 系統。隨著此次新增，目前已有 11 家美國醫院與健康照護網絡投資並啟動兩個或以上的 Focal One 機器人 HIFU 計畫，凸顯大型醫療體系對其使用量、信心與長期承諾正持續提升。

Internationally, we achieved a record six capital sales in the first quarter, reflecting the continued expansion of our global commercial reach, supported by our established and growing sales channel infrastructure. Performance in Europe was particularly strong.

在國際市場方面，我們第一季創紀錄地達成 6 台資本設備銷售，反映我們在既有且持續成長的銷售通路基礎設施支持下，全球商業觸角持續擴張。歐洲市場表現尤其強勁。

In France, we completed our first cash sale following the French National Health System's decision to provide universal coverage for the Focal One HIFU procedure.

在法國，法國國家健康保險體系決定對 Focal One HIFU 手術提供全民給付後，我們完成了首筆現金銷售。

As a reminder, this coverage decision was supported by results from the landmark HIFI study, a large prospective comparative trial that demonstrated positive efficacy outcomes for Focal One robotic HIFU as compared with radical prostatectomy in the treatment of prostate cancer.

提醒各位，這項給付決策係由里程碑式的 HIFI 研究結果所支持；該研究為大型前瞻性比較試驗，顯示在治療前列腺癌方面，Focal One 機器人 HIFU 相較於根治性前列腺切除術具有正向的療效結果。

This quarter also marked the first time our Focal One capital sales were driven by demand across two clinical indications, prostate cancer and deep infiltrating endometriosis. Further highlighting the value of Focal One as both a multi-specialty and multi-indication treatment platform.

本季也標誌著我們的 Focal One 資本設備銷售首次由兩項臨床適應症的需求所驅動：前列腺癌與深部浸潤型子宮內膜異位症。進一步凸顯 Focal One 作為多專科、且具多適應症的治療平台之價值。

In the United Kingdom, Cleveland Clinic London converted to a cash sale supported by strong engagement from global thought leaders in both urology and gynaecology departments, which plan to utilize Focal One Robotic HIFU for the treatment of both prostate cancer and endometriosis.

在英國，Cleveland Clinic London 在泌尿科與婦科兩個部門的全球意見領袖高度參與支持下，轉為現金銷售；該院計畫使用 Focal One 機器人 HIFU 治療前列腺癌與子宮內膜異位症。

In Eastern Europe, we achieved our first Focal One cash sale in Hungary, driven by the hospital's strategic initiative to expand treatment capabilities for both prostate cancer and endometriosis.

在東歐，我們在匈牙利達成首筆 Focal One 現金銷售，係由該院擴充前列腺癌與子宮內膜異位症治療能力的策略性計畫所帶動。

These placements are important as they recognize Focal One robotic HIFU as the only Mult indication focal therapy platform to deliver broad clinical utility across both men's and women's health. In the Americas, we delivered our first Focal One system in Mexico, further expanding our growing clinical regional footprint, which now includes Brazil, Argentina, Chile, Panama and Mexico. This is a result of our growing and expanding sales channel throughout this region.

這些裝機相當重要，因其肯定 Focal One 機器人 HIFU 為唯一的多適應症局部治療平台，能在男性與女性健康兩大領域提供廣泛的臨床效用。在美洲地區，我們於墨西哥交付首套 Focal One 系統，進一步擴大我們持續成長的區域臨床版圖，目前已涵蓋巴西、阿根廷、智利、巴拿馬與墨西哥。這是我們在該地區銷售通路持續成長與擴張的成果。

Turning to utilization.

接著談使用量。

US procedure volumes increased 53% year-over-year. This significant growth was driven by physicians and hospital systems that increasingly recognize the importance of offering Focal One as a cornerstone focal therapy treatment within a comprehensive prostate cancer program.

美國手術量年對年成長 53%。這項顯著成長係由醫師與醫院體系所帶動；他們日益認同在完整的前列腺癌治療計畫中，提供 Focal One 作為核心局部治療方案的重要性。

As we continue to expand the clinical applications of Focal One Robotic HIFU and bring meaningful value to a broader population of prostate cancer patients, we also remain focused on the significant unmet need in patients who experience recurrence following failed radiation therapy.

在我們持續擴展 Focal One 機器人 HIFU 的臨床應用、並為更廣泛的前列腺癌患者族群帶來實質價值的同時，我們也持續聚焦於一項重大未被滿足的需求：放射治療失敗後復發的患者。

Radiation therapy failure rates reported in the clinical literature remains significant and treatment options for these patients are extremely limited, often consisting primarily of hormone deprivation therapy, which can carry debilitating long-lasting side effects that materially impact the patient's quality of life.

臨床文獻所報告的放射治療失敗率仍然相當可觀，而這些患者的治療選項極其有限，往往主要只能採用荷爾蒙剝奪治療；此療法可能帶來使人衰弱且長期的副作用，並對患者生活品質造成重大影響。

Our recent announcement regarding the peer-reviewed publication of the HIFI-2 study further strengthens our global leadership position in focal therapy. This study is significant for several reasons. First, it represents the largest prospective study ever conducted, enrolling more than 500 patients evaluating salvage treatment following recurrence after failed radiation therapy.

我們近期宣布 HIFI-2 研究已於同儕審查期刊發表，進一步鞏固我們在局部治療領域的全球領導地位。此研究之所以重要，原因有數點。首先，這是迄今規模最大的前瞻性研究，納入超過 500 名患者，用以評估放射治療失敗後復發患者的挽救性治療。

Second, HIFI-2 is the largest prospective study assessing the use of Focal One robotic HIFU within this important patient population.

第二，HIFI-2 是目前在這一重要患者族群中，評估使用 Focal One 機器人 HIFU 的最大規模前瞻性研究。

Importantly, the study demonstrated clinically meaningful oncologic control with 71% of the overall patient population avoiding hormone deprivation therapy at 30 months. Additionally, in a rigorously selected subgroup of patients, 84% avoided hormone deprivation therapy within the same follow-up time period.

重要的是，研究顯示具臨床意義的腫瘤控制效果：在 30 個月時，整體患者族群中有 71% 避免了荷爾蒙剝奪治療。此外，在嚴格篩選的患者亞組中，在相同追蹤期間有 84% 避免了荷爾蒙剝奪治療。

These positive results show promise for use of Focal One HIFU as a breakthrough treatment for this important population of men who have previously been left with limited options that result in negative long-lasting side effects.

這些正面結果顯示，Focal One HIFU 有望成為此一重要男性族群的突破性治療選項；過去他們的選擇有限，且往往會帶來負面且長期的副作用。

It is also important to note that the National Comprehensive Cancer Network guidelines already recommend HIFU as a treatment option for patients with prostate cancer recurrence following failed radiation therapy, and both Medicare and commercial payers currently provide reimbursement coverage for the use of Focal one robotic HIFU in this clinical setting.

同樣重要的是，國家綜合癌症網絡（NCCN）指引已建議 HIFU 作為放射治療失敗後前列腺癌復發患者的治療選項；且目前 Medicare 與商業保險給付方在此臨床情境下，皆提供使用 Focal One 機器人 HIFU 的報銷給付。

In summary, the publication of the HIFI 2 study further reinforces Focal One's unique position as a non-invasive organ-sparing and function-preserving treatment option for a patient population that has historically faced limited therapeutic alternatives beyond palliative care.

總結而言，HIFI 2 研究的發表進一步鞏固了 Focal One 的獨特定位：作為一種非侵入性、保留器官並維持功能的治療選項，適用於一個歷來除緩和治療外幾乎缺乏其他治療替代方案的患者族群。

In urology and moving beyond prostate cancer, we continue to invest in expanded clinical indications for Focal One.

在泌尿科領域，並且不僅限於前列腺癌，我們持續投資於擴大 Focal One 的臨床適應症。

We are currently accelerating clinical studies evaluating the use of Focal One for the treatment of benign prostatic hyperplasia or BPH. In early March, our clinical team collaborated with urologists from the New York Icahn School of Medicine at Mount Sinai to treat patients in Chile as part of an ongoing clinical research study.

我們目前正加速進行臨床研究，以評估 Focal One 用於治療良性前列腺增生（BPH）。3 月上旬，我們的臨床團隊與紐約西奈山伊坎醫學院（Icahn School of Medicine at Mount Sinai）的泌尿科醫師合作，作為一項持續進行的臨床研究的一部分，在智利為患者進行治療。

Based on encouraging early outcomes, the trial will continue with plans to enroll and to treat a second cohort of patients over the coming months. In addition, a separate IRB-approved study will be conducted at Mount Sinai in New York following patient evaluations from the Chile study.

基於令人鼓舞的早期結果，該試驗將持續進行，並計畫在未來數月招募並治療第二批患者。此外，在完成對智利研究患者的評估後，紐約西奈山也將開展另一項經 IRB 核准的研究。

Together, these initiatives reflect our broader strategy to expand the clinical utility of Focal One and to further strengthen the body of evidence supporting its expanded use across additional urologic applications.

綜合而言，這些舉措反映了我們更廣泛的策略：擴大 Focal One 的臨床效用，並進一步強化支持其在更多泌尿科應用中擴大使用的證據基礎。

Within gynaecology, our commercial rollout in endometriosis continues to gain momentum across Europe. As mentioned earlier, multiple hospitals have now invested in Focal One Robotic HIFU to support the treatment of both prostate cancer and endometriosis, reinforcing the platform's growing multi-specialty clinical utility.

在婦科領域，我們在子宮內膜異位症方面的商業推廣於歐洲持續加速。如先前所提，多家醫院現已投資 Focal One 機器人 HIFU，以支援前列腺癌與子宮內膜異位症的治療，進一步印證該平台日益增長的跨專科臨床效用。

During the quarter, we actively participated in two major scientific meetings, the European Endometriosis Congress and the British Society for Gynaecological Endoscopy Annual Scientific Meeting. Our Focal One sponsored symposium at the European Endometriosis Congress in Bologna, Italy, attracted more than 400 attendees and generated strong engagement from leading clinicians and specialists across key international markets.

本季度期間，我們積極參與兩場重要的科學會議：歐洲子宮內膜異位症大會，以及英國婦科內視鏡學會年度科學會議。我們在義大利波隆那舉辦的歐洲子宮內膜異位症大會上所贊助的 Focal One 專題研討會，吸引超過 400 名與會者，並在多個關鍵國際市場的領先臨床醫師與專家之間引發高度互動。

On the clinical front, Croix-Rousse Hospital in Lyon, France remains central to our expansion strategy, serving both as a high-volume treatment center and as our primary physician training hub for endometriosis. In parallel, Focal One robotic HIFU endometriosis programs are beginning to launch and enroll patients.

在臨床方面，法國里昂的 Croix-Rousse 醫院仍是我們擴張策略的核心，既是高量治療中心，也是我們子宮內膜異位症醫師訓練的主要樞紐。同時，Focal One 機器人 HIFU 的子宮內膜異位症計畫也開始啟動並招募患者。

We are pleased to confirm that first patient treatments at several newly established clinical centers are expected to begin in the coming weeks, representing an important milestone as these programs transition from physician training into active clinical adoption.

我們很高興確認，數個新設立的臨床中心預計將在未來幾週開始進行首例患者治療；這代表一項重要里程碑，因為這些計畫正從醫師訓練階段轉入實際臨床採用。

At these recent scientific meetings, investigators also presented positive long-term follow-up data from the Phase II and Phase III randomized controlled trial, demonstrating effective and durable outcomes that remain consistent across all patient cohorts. These findings further reinforce our confidence in the long-term clinical value of this treatment approach.

在近期的科學會議上，研究者亦發表了第二期與第三期隨機對照試驗的正面長期追蹤數據，顯示療效良好且持久，並在所有患者隊列中保持一致。這些發現進一步強化我們對此治療方法長期臨床價值的信心。

Importantly, we believe the growing body of clinical evidence establishes a strong foundation to support the advancement along the regulatory pathway.

重要的是，我們相信日益累積的臨床證據已建立堅實基礎，可支持沿著法規審查途徑持續推進。

Collectively, these commercial and clinical developments further strengthen our conviction that endometriosis represents a significant long-term growth opportunity for Focal One. As we mentioned on our last call in March, we collaborated with the leadership team from the NYU Langone Department of Urology to host the inaugural International Symposium on Robotic Focal therapy in New York City.

整體而言，這些商業與臨床進展進一步強化我們的信念：子宮內膜異位症對 Focal One 而言代表一項重要的長期成長機會。正如我們在 3 月上次電話會議中提到的，我們與 NYU Langone 泌尿科系的領導團隊合作，於紐約市主辦首屆「機器人局部治療國際研討會」。

This event attracted physicians from both the US and international markets who are either developing or actively evaluating focal therapy programs centered around Focal One Robotic HIFU.

該活動吸引了來自美國及國際市場的醫師，他們正建立或積極評估以 Focal One 機器人 HIFU 為核心的局部治療計畫。

The strong attendance and overall success of this educational program further highlights the growing momentum we continue to see throughout the global urology community.

此教育計畫的踴躍出席與整體成功，進一步凸顯我們在全球泌尿科社群中持續看到的成長動能。

Building on the success of the NYU symposium and in response to increasing demand from urologists seeking to integrate Focal One technology into their practices, we will be sponsoring a CME accredited physician training course at Memorial Sloan Kettering Cancer Center on Thursday, May 14.

在 NYU 研討會成功的基礎上，並回應越來越多泌尿科醫師希望將 Focal One 技術導入其臨床實務的需求，我們將於 5 月 14 日（週四）在紀念斯隆—凱特琳癌症中心（Memorial Sloan Kettering Cancer Center）贊助一場具 CME 認證的醫師訓練課程。

MSKCC is ranked as the leading urology-focused comprehensive cancer center in the United States and is a leading and highly experienced user of Focal One robotic HIFU globally. Looking ahead, we will deliver a strong presence at the upcoming Annual Meeting of the American Urological Association in Washington, D.C. starting on May 15.

MSKCC 被評為美國首屈一指、以泌尿科為重點的綜合癌症中心，亦是全球使用 Focal One 機器人 HIFU 的領先且經驗豐富的機構之一。展望未來，我們將自 5 月 15 日起在華盛頓特區舉行的美國泌尿科學會（AUA）年會上展現強勢存在感。

The AUA meeting represents the largest global gathering of urologists and serves as a premier forum where the latest advances in urology are presented and translated into clinical practice.

AUA 年會是全球規模最大的泌尿科醫師聚會，亦是展示泌尿科最新進展並將其轉化為臨床實務的頂尖平台。

Throughout the conference, we will host multiple educational and clinical engagement activities, including booth presentations, semi-live Focal One procedures, panel discussions and handson Focal One simulation sessions led by key clinical thought leaders.

在整個會議期間，我們將舉辦多項教育與臨床互動活動，包括攤位展示、半實況的 Focal One 手術示範、座談討論，以及由關鍵臨床意見領袖帶領的 Focal One 實作模擬訓練課程。

In addition, we will be hosting numerous analyst and investor meetings throughout the scientific program. And finally, we are excited to announce that we will host an Investor Day on June 1 at the NASDAQ MarketSite in New York City.

此外，我們也將在科學議程期間安排多場分析師與投資人會議。最後，我們很高興宣布，將於 6 月 1 日在紐約市 NASDAQ MarketSite 舉辦投資人日（Investor Day）。

During this event, we will provide important updates on our commercial growth strategy, clinical indication expansion and product innovation road map as we continue to build increased momentum across our business. We believe the opportunity ahead of us has never been greater, and we look forward to sharing our vision for the next phase of growth.

在此活動中，我們將就商業成長策略、臨床適應症擴展，以及產品創新路線圖提供重要更新，並持續推動業務動能提升。我們相信，眼前的機會前所未有地龐大，並期待分享我們對下一階段成長的願景。

We hope you will join us in New York. With that, I would now like to turn the call over to Ken to review our financial results.

我們希望您能在紐約與我們相聚。接下來，我想把電話會議交給 Ken，請他回顧我們的財務結果。

Thank you, Ryan, and good morning, everyone. As a reminder, all figures will now be reported in US dollars. As Ryan mentioned earlier, our record revenue performance for the first quarter of 2026 was driven by continued strength in our core HIFU business, which grew 78% compared to the first quarter of 2025.

謝謝你，Ryan，各位早安。提醒一下，所有數字接下來都將以美元呈報。如 Ryan 先前提到，我們 2026 年第一季創紀錄的營收表現，主要來自核心 HIFU 業務的持續強勁成長；相較於 2025 年第一季，該業務成長了 78%。

Growth in our HIFU business was partially offset by expected continued decline in our noncore distribution and ESWL businesses, which declined by 20% in Q1 2026 versus Q1 2025.

我們的 HIFU 業務成長，部分被我們非核心的經銷與 ESWL 業務如預期持續下滑所抵銷；該等業務在 2026 年第一季相較 2025 年第一季下滑 20%。

Total company-wide revenue for the first quarter was $17.8 million, an increase of 25% as compared to total revenue of $14.3 million for the same period in 2025. Total HIFU revenue for the first quarter was $11.6 million as compared to $6.5 million for the first quarter of 2025.

公司第一季整體營收為 1,780 萬美元，較 2025 年同期總營收 1,430 萬美元成長 25%。第一季 HIFU 總營收為 1,160 萬美元，較 2025 年第一季的 650 萬美元增加。

The 78% year-over-year increase in HIFU revenue was driven by 11 Focal One capital sales in the first quarter of 2026 versus 6 capital sales in the prior year period as well as a 30% year-over-year increase in Focal One treatment-driven revenue.

HIFU 營收年增 78%，主要受 2026 年第一季 Focal One 資本設備銷售 11 台（相較前一年同期 6 台）所帶動，此外 Focal One 以治療量驅動的營收亦年增 30%。

As mentioned earlier, Focal One procedures in the US grew 53% year-over-year. Gross profit for the first quarter was $8.1 million compared to $6 million for the prior year period. Gross margin was 45.7% in the first quarter compared to 42% for the first quarter of 2025. The 370 basis points increase in gross margin year-over-year was primarily due to the strategic shift to our higher-margin HIFU business segment, which had gross margins of 51.4% for the first quarter compared to 48.6% for the first quarter of 2025.

如先前提到，Focal One 在美國的手術量年增 53%。第一季毛利為 810 萬美元，較前一年同期的 600 萬美元增加。第一季毛利率為 45.7%，相較 2025 年第一季的 42%。毛利率年增 370 個基點，主要由於策略性轉向毛利率較高的 HIFU 業務分部；該分部第一季毛利率為 51.4%，相較 2025 年第一季的 48.6%。

Operating expenses were $15.5 million for the first quarter compared to $12.3 million for the same period in 2025.

第一季營業費用為 1,550 萬美元，較 2025 年同期的 1,230 萬美元增加。

The increase in operating expenses was driven by higher sales expense related to increased system sales as well as incremental costs associated with our transition to a US domestic filer. Operating loss for the first quarter was $7.4 million as compared to $6.3 million in the first quarter of 2025.

營業費用增加，主要由於系統銷售增加帶動較高的銷售費用，以及我們轉型為美國國內申報公司所產生的新增成本。第一季營業損失為 740 萬美元，較 2025 年第一季的 630 萬美元增加。

Net loss for the first quarter was $9.1 million or $0.24 per share as compared to a net loss of $7.4 million or $0.20 per share in the prior year period. The increase in net loss was driven by incremental operating loss of $1.1 million as well as a $1.7 million non-cash charge related to warrants and interest expense on the European Investment Bank Cante drawdown. This was partially offset by $1.1 million positive currency impact versus the prior year period.

第一季淨損為 910 萬美元（每股 0.24 美元），相較前一年同期淨損 740 萬美元（每股 0.20 美元）。淨損增加主要來自營業損失增加 110 萬美元，以及與認股權證相關的 170 萬美元非現金費用與歐洲投資銀行（EIB）Cante 提款的利息費用。上述部分被相較前一年同期 110 萬美元的正向匯兌影響所抵銷。

Turning to the balance sheet.

接下來談資產負債表。

Inventory increased $13.3 million at the end of the first quarter as compared to $12.8 million at the end of Q4 2025. This sequential increase in inventory was due to a higher level of HIFU-related inventory to meet the increased demand for Focal One systems as our business momentum continues to grow.

第一季末存貨為 1,330 萬美元，較 2025 年第四季末的 1,280 萬美元增加。存貨的季增主要因為為因應 Focal One 系統需求增加、且我們業務動能持續增長，而提高 HIFU 相關存貨水位。

Cash and cash equivalents at the end of the first quarter were $15 million compared to $20.5 million at the end of Q4 2025.

第一季末現金及約當現金為 1,500 萬美元，較 2025 年第四季末的 2,050 萬美元減少。

The sequential decrease was driven primarily by cash used in operating activities to support our strategic investments in accelerating HIFU growth.

該季減主要是因為營運活動使用現金，以支持我們加速 HIFU 成長的策略性投資。

Subsequent to the end of the first quarter, on April 20, we received the second tranche from the European Investment Bank credit facility totalling approximately $14 million, which will further strengthen our balance sheet and will be reflected in our Q2 financial statements.

在第一季結束後的 4 月 20 日，我們自歐洲投資銀行信貸額度收到第二筆撥款，合計約 1,400 萬美元，將進一步強化我們的資產負債表，並將反映於第二季財務報表中。

The tariff impact on the first quarter P&L and balance sheet was approximately $400,000. We are reiterating our full year 2026 guidance.

關稅對第一季損益表與資產負債表的影響約為 40 萬美元。我們重申 2026 全年財測指引。

We continue to expect core HIFU revenue in the range of $50 million to $54 million, representing 34% to 45% growth over 2025 and combined noncore revenue in the range of $22 million to $26 million.

我們仍預期核心 HIFU 營收介於 5,000 萬至 5,400 萬美元，代表相較 2025 年成長 34% 至 45%；合計非核心營收則預期介於 2,200 萬至 2,600 萬美元。

I will now turn it back to Ryan for closing remarks. Ryan?

我現在把時間交回給 Ryan 做結語。Ryan？

Thanks, Ken. As we execute through 2026, our priorities remain clear: commercial execution and continuing to deepen penetration across leading centers, indication expansion and advancing our endometriosis and BPH programs, technology and innovation positioning Focal One as a leader in the space with the most advanced robotic focal therapy platform. Q1 was a great start, and we are confident in our ability to deliver on our 2026 priorities.

謝謝，Ken。在我們推進 2026 年的執行過程中，我們的優先事項依然明確：商業執行並持續深化在領先中心的滲透；適應症擴展並推進我們的子宮內膜異位症與 BPH 計畫；以及以技術與創新定位 Focal One，使其成為該領域的領導者，並擁有最先進的機器人局部治療平台。第一季是很好的開局，我們對於達成 2026 年優先事項的能力充滿信心。

Operator, please open the line for questions.

接線員，請開放提問。

(Operator Instructions) Michael Sarcone, Jefferies.

(接線員指示) Michael Sarcone，Jefferies。

Good morning, and thanks for taking our questions. Just to start, the US HIFU procedure growth, 53%, really impressive, and that's a nice acceleration. Maybe you can just talk a little bit more about what you're seeing in terms of utilization and what's driving that growth, and then, I guess, secondly, how sustainable is that level of growth, in your opinion?

早安，謝謝讓我們提問。先從美國 HIFU 手術量成長 53% 開始，真的很亮眼，而且加速得很不錯。也許你可以再多談一點你們在使用率方面看到的情況、以及是什麼在驅動這個成長；接著我想問的是，以你的看法，這樣的成長幅度有多可持續？

Yeah, Michael. First off, yes, we had good procedure growth, and again, on a quarter-over-quarter basis, double-digit growth and so, again, we're seeing increased demand for non-radical treatments, obviously, focal therapy being the discussion point.

好的，Michael。首先，是的，我們的手術量成長表現不錯；而且以季對季來看也是雙位數成長，所以我們再次看到對非根治性治療的需求增加，當然局部治療（focal therapy）是討論的重點。

So I see -- we see a couple of things. One is our install-based customers continue to evolve with their programs.

所以我看到——我們看到幾件事。第一，我們既有裝機客戶持續在其計畫上演進與成熟。

We've expanded training to additional doctors, so that has a direct input to increased volume of procedures, but also we're getting better at ramping programs and so obviously selling more capital creates more capacity to treat more patients.

我們把訓練擴展到更多醫師，這會直接帶動手術量增加；同時我們也更擅長讓各中心的計畫加速爬坡，因此銷售更多資本設備自然會帶來更大的治療量能、可治療更多病患。

So I think it's really a culmination of a number of things. I think, the patient audience, as we know, prostate cancer is a heterogeneous cancer. So patients are now doing more research.

所以我認為這其實是多項因素的綜合結果。我想病患族群方面，如我們所知，前列腺癌是一種異質性癌症。因此病患現在會做更多研究。

They're really looking at their options closely and if they're really not a candidate. For radical treatments, then they should ideally be on active surveillance or they should be a target for focal therapy.

他們會非常仔細地評估各種選項；如果他們確實不適合根治性治療，那麼理想上應該採取主動監測（active surveillance），或成為局部治療的目標族群。

So, we see very good engagement from the centers that have our technology and certainly more centers looking to adopt it. And so, again, we have a dedicated sales force on.

因此，我們看到已採用我們技術的中心有非常好的參與度，當然也有更多中心正在評估導入。因此，再次強調，我們有一支專注的銷售團隊在運作。

On the clinical side, that's doing an excellent job of advancing the programs. And again, we sell and build a program. So we feel very confident that we'll continue to grow our procedures.

在臨床端，他們在推進各項計畫方面做得非常出色。而且我們是銷售並建立一個完整的計畫。因此我們非常有信心，我們的手術量將會持續成長。

It's a very important metric for us. And of course, it's important to driving increased margin as well as overall revenue.

這對我們而言是一項非常重要的衡量指標。當然，這也有助於推動毛利率提升以及整體營收成長。

That's helpful. Thanks, Ryan. And I guess just to follow-up on that when you think about your US Accounts in particular for Focal 1, I mean, can you give us some sense of what's the average number of surgeons using the system at accounts today and maybe talk about how that's evolved over the past few quarters?

這很有幫助。謝謝你，Ryan。我想就此再追問一下，特別是針對你們在美國的 Focal 1 客戶，你能否讓我們了解一下，目前各帳戶平均有多少位外科醫師在使用該系統，並談談過去幾季這個數字是如何演變的？

Yeah, so very good question. So some of our earlier programs, we had individual surgeons or urologists that drove deals. And of course, as we described it as a program may involve a number of urologists.

是的，這是個很好的問題。我們早期的一些專案，是由個別外科醫師或泌尿科醫師推動成交。當然，如我們所描述，一個專案可能會涵蓋多位泌尿科醫師。

So we've moved from kind of that 1.5 number of trained doctors to nearly two per site two or more. We have some sites where we have as many as six urologists trained to access Focal 1 and more in the queue to be trained in coming quarters, including weeks.

因此，我們已從每個據點約 1.5 位受訓醫師，提升到接近每個據點兩位、甚至兩位以上。我們有些據點多達六位泌尿科醫師已受訓可使用 Focal 1，且還有更多人在排隊等待於接下來幾季（甚至幾週內）接受訓練。

So we're a little more prescriptive now as we've matured in our business. We want to train more urologists.

所以，隨著我們業務日趨成熟，我們現在的做法更具指導性。我們希望訓練更多泌尿科醫師。

It really depends. It varies by institution, academic centers versus community hospitals but we're in that kind of two or more range is our goal and certainly, in some instances, as I referenced, we have up to six or seven urologists trained and now starting to access Vocal One.

這確實取決於情況。不同機構會有差異，例如學術中心與社區醫院；但我們的目標大致是在每個據點兩位或以上，當然在某些情況下，如我提到的，我們已經有多達六到七位泌尿科醫師受訓，並且現在開始使用 Vocal One。

So that's really positive for us. And we'll continue to focus on that as we launch new programs.

所以這對我們來說非常正面。而且在我們推出新專案時，會持續聚焦在這一點。

All right. And then if I could just squeeze in one more, just on the endometriosis side, sounds like some really solid momentum overseas. I guess just a two-parter here.

好的。如果我可以再塞一個問題，關於子宮內膜異位症這一塊，聽起來你們在海外有很扎實的動能。我想這裡有兩個部分。

How are you thinking about financial contribution as you start to see endometriosis application grow? And then just secondly here, any update on what's going on with your US Efforts in endometriosis? Thank you.

當你們開始看到子宮內膜異位症的應用成長時，你們如何看待其財務貢獻？第二，美國在子宮內膜異位症方面的推進目前有什麼最新進展嗎？謝謝。

Yeah, so as we talked about, we had some great wins in the quarter with gynaecologists weighing in on endometriosis.

是的，如我們所談到的，本季我們在婦科醫師採用子宮內膜異位症方面取得了一些很好的勝利。

So again, bringing in a second specialty, we're not only a urology company and men's health, but we're also becoming a women's health company. So I think what you're seeing there is certainly, more activity on the capital sales side.

因此，再次引入第二個專科，我們不僅是一家泌尿科與男性健康公司，也正在成為一家女性健康公司。所以我認為你看到的，確實是在資本設備銷售端有更多活動。

In the short-term, we'll see that I think we'll see more of that coming because we can do more procedures on the same platform, Focal One.

短期內，我們會看到這一點，而且我認為未來還會看到更多，因為我們可以在同一個平台 Focal One 上執行更多手術。

So it may be too early to say in our models, we'll have more that we can share in future updates of how that may play into the overall revenue number, including recurring revenue, right, on disposables or consumables.

所以在我們的模型中，現在可能還太早下定論；未來更新時，我們會分享更多，說明這可能如何影響整體營收數字，包括經常性營收，例如一次性耗材或消耗品。

As far as the US, we, as noted, we're still waiting for published data from the randomized control trial that has now follow-up out to 24 months, coming up on 24 months, and then there was a subset of patients who were part of the sham arm who we're treated, and we're coming up to 12 months follow-up.

至於美國方面，如先前所述，我們仍在等待隨機對照試驗的已發表數據；該試驗目前追蹤期已延伸至 24 個月、即將達到 24 個月，另外還有一部分屬於假手術（sham）組的患者後續接受了治療，我們也即將取得其 12 個月追蹤結果。

We're expecting that data to be published likely sometime this year that data will be very important for us to revisit our strategy with the FDA in the US.

我們預期這些數據很可能會在今年某個時間點發表；這些數據對我們重新檢視在美國與 FDA 的策略將非常重要。

So the good news is some of this data has been recently discussed and presented at the two meetings I referenced in Europe, and there seems to be very good engagement from the thought leaders.

好消息是，其中部分數據最近已在我提到的歐洲兩場會議中被討論並發表，且看起來獲得意見領袖非常好的參與度。

Who specialize in endometriosis. But when the new data is presented, I think that will be an opportunity, again, to take that, and that will play directly back into the conversations that we'll have with the FDA.

他們專精於子宮內膜異位症。但當新的數據被呈現時，我認為那將是一次機會，再次把這些資料帶回來，並直接回饋到我們與 FDA 的對話中。

Great. Thanks, Ryan.

很好。謝謝你，Ryan。

Thank you.

謝謝。

Jason Bednar, Piper Sandler.

Jason Bednar，Piper Sandler。

Hey, guys. Good morning. Thanks for taking the questions, and congrats on the quarter here. I wanted to start on the HIFU business here in the US. Your placements are doing well globally that's obviously pretty good growth here in the quarter.

嗨，各位。早安。謝謝讓我提問，也恭喜本季表現。我想先從美國的 HIFU 業務談起。你們的裝機量在全球表現不錯，本季顯然也有相當好的成長。

A lot of that can be attributed to this international expansion that you're touching on. I know we're a few years into this more focused commercial initiative around HIFU in the US

其中很大一部分可歸因於你們提到的國際擴張。我知道你們在美國針對 HIFU 的更聚焦商業化計畫也已推進了幾年。

As well, though. Can you take us around through how you're thinking about the US Market? What does that runway look like in the US? And. think about opportunities in high store, are they just simply greater now outside the US, and that's why we're seeing, more emphasis and growth from, again, from kind of your ex-US Markets.

同時也是如此。你能帶我們了解一下你們如何看待美國市場嗎？美國的成長跑道看起來如何？另外，談到 HIFU 的機會，是否只是因為目前美國以外的機會更大，所以我們才看到你們更強調、且成長更多來自美國以外市場？

Yes, so again, we sell what we believe and clearly have demonstrated a clinically necessary strategic revenue-enhancing service line in the number one diagnosed cancer in men.

是的，所以再次強調，我們銷售的是我們相信、且已清楚證明在臨床上必要、並能提升營收的策略性服務線，聚焦於男性最常被診斷的癌症。

So prostate cancer obviously is an anchor point in men's health. So looking at the system sales, we have a strong pipeline, and that pipeline is building.

因此，前列腺癌顯然是男性健康的核心切入點。就系統銷售而言，我們有強勁的案源管線，而且這個管線正在擴大。

I think hospitals are also starting to recognize the need to answer to the call of offering focal therapy. Focal therapy is emerging as a treatment category, as we know, but it is a necessity to be a comprehensive offering in a hospital and we are looking at our system sales.

我認為醫院也開始認知到，需要回應提供局部治療（focal therapy）的需求。如我們所知，局部治療正逐步成為一個治療類別，但要成為醫院完整的治療選項，這是必要的；因此我們也在檢視我們的系統銷售。

We're really early in this adoption lifecycle. I mean, we're growing here, but the upside is significant for the company and looking at total numbers of potential sales for the future, and I'm talking about the US.

我們在這個採用生命週期中仍非常早期。我的意思是，我們正在成長，但對公司而言上行空間相當可觀；從未來潛在銷售總量來看——我指的是美國市場。

So, again, we continue to focus on building our active pipelines. As you can see, we continue to sell in academic centers, but also growing more rapidly in community hospitals and that's important, and we had some notable wins as we look across our install base.

所以，再次強調，我們會持續專注於建立我們的活躍案源管線。如你所見，我們持續在學術中心成交，同時在社區醫院的成長更快，這很重要；而且當我們檢視整體裝機基礎時，也有一些值得注意的勝利。

In the outside US, I think the important thing to understand is our legacy history in urology as a company in extracorporeal shockwave lithotripsy, we already have an established sales channel, so now we're fully activating on that sales channel.

在美國以外市場，我認為重要的是要理解：我們公司在泌尿科領域、體外震波碎石術方面有長期歷史，因此我們已建立既有的銷售通路；現在我們正全面啟動並活化這個銷售通路。

A number of us came from Intuitive Surgical, and we know the playbook, and we're applying that playbook like we did back in the early days of radical prostatectomy and so I think we're seeing those results play out now. So the outside US Market continues to gain traction as we continue to move the US Market.

我們當中有不少人來自 Intuitive Surgical，我們熟悉那套作法（playbook），而且正如當年在根治性前列腺切除術早期一樣，我們正在套用那套作法，因此我認為我們現在正看到那些成果逐步展現。因此，隨著我們持續推進美國市場，美國以外的市場也持續獲得更多動能。

And to add to that, as we look at our mix for the year, it will still be predominantly in the US when it comes to unit sales, and as a reminder, we sell direct in the US, so we can demand a higher ASP both on our system and on our consumable products.

另外補充一下，從我們今年的組合來看，就單位銷售量而言，仍將以美國為主；並提醒一下，我們在美國採直銷模式，因此無論是系統或耗材產品，我們都能要求較高的 ASP（平均銷售價格）。

Okay, so just to clarify, Ken, you're saying, embedded in the guidance for the rest of this year, what's implied is that US Accounts for a disproportionate amount of the mix of system sales, correct?

好的，為了釐清一下，Ken，你的意思是，在今年剩餘期間的指引中，所隱含的是：美國在系統銷售的組合中占比不成比例地更高，對嗎？

Okay, perfect.

好的，完美。

Maybe the next one on -- you obviously have the biggest conference coming up here with AUA. Is there anything quantitative you're prepared to talk about in terms of sessions, meetings, exposure?

也許下一題——你們顯然即將迎來最大的會議，也就是 AUA。在場次、會議、曝光度等方面，有沒有任何你們準備好可以量化分享的內容？

I know, Ryan, you mentioned a lot of those that you have planned, but how this year's conference compares to the last few years as you look to broaden your exposure and deepen your relationships?

我知道，Ryan，你提到你們規劃了很多，但當你們希望擴大曝光並深化關係時，今年的會議與過去幾年相比如何？

Yes, so a couple of good things for this year. The meeting is in Washington, D.C.

是的，今年有幾個好消息。會議在華盛頓特區舉行。

Next week, and as communicated on the call, we have a course going on with Memorial Sloan Kettering Cancer Center, so that's on the front end of AUA. The day before, and then we're going to be directly in Washington, D.C. With the scientific program of AUA.

就在下週；而且如同在電話會議中所提到的，我們與 Memorial Sloan Kettering Cancer Center 會有一個課程，因此那會在 AUA 的前段進行。在前一天，接著我們將直接在華盛頓特區參與 AUA 的科學議程。

So as we look at it, we will have a very strong showing at this meeting, a lot of busy activity at our booth, we have presentations, we have the ability to do case simulations, which are really important for new customers that get to get on the Focal One platform and go through an actual treatment, they see how easy it is to set up the treatment and what the robotic platform can do for them.

因此整體來看，我們在這次會議上會有非常強的曝光：我們的攤位會有大量且忙碌的活動；我們有簡報發表；我們也能進行病例模擬，這對新客戶非常重要，因為他們可以上手 Focal One 平台並走完整個實際治療流程，看到治療設定有多容易，以及這個機器人平台能為他們做到什麼。

Beyond that, I would just say there are a scattering of different scientific presentations throughout the meeting, abstracts either presented orally or in some of the poster sessions or even some discussion on the growth of focal therapy.

除此之外，我想說在整個會議期間，還會零星分布各種不同的科學發表，摘要可能以口頭報告、海報展示，甚至也會有一些關於局部治療（focal therapy）成長的討論。

I think the biggest thing that we see is focal therapy is becoming more of a household word in the treatment category of prostate cancer.

我認為我們看到最重要的一點是：在前列腺癌的治療領域中，局部治療正逐漸成為家喻戶曉的詞彙。

As it continues to evolve, we're in a new era of treatment, so we'll see some of that going on out in the Scientific Sessions. We have a number of presentations from key thought leaders at our booth.

隨著它持續演進，我們正處於治療的新時代，因此在科學場次中也會看到一些相關內容。我們攤位也會有多位關鍵意見領袖的發表。

We'll have a dinner event that's already sold out, and we're excited about that. That'll be on Saturday night. So we'll have a lot of great activity, and of course, we have a very large booth in the main focused area of the exhibit hall.

我們也會舉辦一場晚宴活動，目前已經售罄，我們對此感到很興奮。活動在週六晚上。因此會有很多很棒的活動；當然，我們在展覽館主要焦點區域也有一個非常大的攤位。

While we're there. We're entertaining a number of discussions with key investors and key analysts. We believe we're a breakout story, so we want to have those conversations and continue the momentum we're building.

在我們在那裡期間，我們也會與多位重要投資人與重要分析師進行多場交流討論。我們相信自己是一個具突破性的故事，因此希望進行這些對話，並延續我們正在建立的動能。

All right, very good. Last one for me, and maybe just shortly after that, Eli, you've got your Investor Day coming up.

好的，非常好。我最後一題，接著不久之後，Eli，你們也即將舉辦 Investor Day。

Should we be prepared for a long-range plan at the Investor Day? Is that something you're going to be prepared to discuss?

在 Investor Day 上，我們是否應該期待你們提出一個長期計畫？這是你們會準備討論的內容嗎？

Yeah, on our Investor Day, really, we're really at an inflection point of our business, so we want to provide a number of key updates, so there will be some updates on our financial models, we'll be talking about kind of the wrap around our commercial strategy of course, we'll be talking about some of the new indications and what we're focusing on there.

是的，在我們的 Investor Day 上，坦白說，我們的業務正處於一個拐點（inflection point），因此我們希望提供多項關鍵更新：會有一些財務模型的更新；我們會談到商業化策略的整體布局；當然也會談到一些新的適應症，以及我們在那方面的重點。

And I think there will be a technology element, something we haven't discussed or shown before, that will be of interest to all attendees. We're investing in some new innovations as it relates to FOCAL 1, but even beyond Focal 1. So I think there will be a lot there for people to learn and understand, and we look forward to sharing those updates accordingly.

我認為也會有一個技術面的元素，是我們以前沒有討論或展示過的，所有與會者都會感興趣。我們正在就 FOCAL 1 相關投入一些新的創新，甚至不僅限於 Focal 1。因此我認為會有很多內容讓大家學習與理解，我們也期待適時分享這些更新。

All right. Thank you very much.

好的。非常感謝。

Thank you.

謝謝。

Thank you. At this time, there are no further questions. I will now turn the meeting back to Ryan Rhodes.

謝謝。此時沒有其他問題。我現在把會議交回給 Ryan Rhodes。

As discussed on this quarter's call, Focal One Robotic HIFU continues to emerge as a market leading focal therapy technology being adopted by more and more physicians and hospitals around the world. Focal One requires no surgery cutting or use of radiation, thus allowing physicians to perform a noninvasive precise robotic targeted ablation that treats only the intended disease areas while preserving the patient's healthy tissue. Its focus as an organ sparing and function-preserving treatment aligns with the direction of modern medicine.

如同本季電話會議所討論，Focal One Robotic HIFU 持續崛起，成為市場領先的局部治療技術，並正被全球越來越多的醫師與醫院採用。Focal One 不需要手術切割或使用放射線，因此讓醫師能執行非侵入性、精準的機器人靶向消融，只治療預定的病灶區域，同時保留病患的健康組織。其作為器官保留與功能保留治療的定位，與現代醫學的發展方向一致。

Importantly, Focal One is not just a device. It's a foundation of program building within health care institutions.

重要的是，Focal One 不僅僅是一台設備。它是在醫療機構內推動方案建置（program building）的基礎。

We believe this multi-specialty multi-indication strategy positions us well for sustained growth and long-term value creation.

我們相信，這項多專科、多適應症的策略，讓我們具備良好條件以實現持續成長並創造長期價值。

I want to thank everyone for joining us on today's call. We look forward to seeing you at the upcoming Annual Meeting of the American Urological Association next week and at our Investor Day and the Jefferies Healthcare Conference, both taking place in New York City in early June. Thank you.

我要感謝各位參與今天的電話會議。我們期待下週在美國泌尿科醫學會（American Urological Association）年度會議與各位見面，也期待在 6 月初於紐約市舉行的 Investor Day 與 Jefferies Healthcare Conference 與各位相見。謝謝。

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect

謝謝。今天的會議到此結束。感謝各位撥冗與會並參與。您現在可以斷線