Edap Tms SA (EDAP) 2023 Q2 法說會逐字稿

Greetings and welcome to the EDAP TMS second-quarter 2023 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 EDAP TMS 2023 年第二季度收益電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

I would now like to turn the conference over to John Fraunces, Managing Director of LifeSci Advisors. Thank you. Please go ahead.

我現在想將會議轉交給 LifeSci Advisors 董事總經理約翰·弗朗西斯 (John Fraunces)。謝謝。請繼續。

Good morning. Thank you for joining us for the EDAP TMS second-quarter 2023 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer; François Dietsch, Chief Financial Officer; and Ken Mobeck, Chief Financial Officer of the US subsidiary.

早上好。感謝您參加我們的 EDAP TMS 2023 年第二季度財務和運營業績電話會議。與我一起參加今天電話會議的是首席執行官 Ryan Rhodes；弗朗索瓦·迪奇 (François Dietsch)，首席財務官；以及美國子公司首席財務官 Ken Mobeck。

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

在開始之前，我想提醒大家，管理層今天的言論可能包含前瞻性陳述，其中包括有關公司增長和擴張計劃的陳述。此類聲明基於管理層當前的預期，並受到許多風險和不確定性的影響，這些風險和不確定性可能導致實際結果與此類前瞻性聲明中描述的結果存在重大差異。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描述的因素。

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

我現在想將電話轉給 EDAP 首席執行官 Ryan Rhodes。瑞安？

Thank you, John, and good morning, everyone. I will start today's call by providing highlights from the second quarter of 2023 and then turn the call over to Ken Mobeck, our US CFO, who will then present the corresponding details of financial performance.

謝謝約翰，大家早上好。我將首先介紹 2023 年第二季度的要點，然後將電話轉交給我們的美國首席財務官 Ken Mobeck，他將介紹相應的財務業績細節。

I'm pleased to report that we achieved record second-quarter and first half revenues, reflecting strong underlying demand for Focal One HIFU technology. Second-quarter revenue of EUR14.3 million was predominantly driven by new US capital placements at leading academic and community hospitals, as well as from increased procedure volumes leading to higher disposable sales. We are very encouraged by the higher utilization trends of Focal One HIFU amongst our existing customers, which helped EDAP generate strong year over year HIFU revenue growth of 63.6% for the quarter.

我很高興地向大家報告，我們第二季度和上半年的收入創歷史新高，反映出對 Focal One HIFU 技術的強勁潛在需求。第二季度收入為 1,430 萬歐元，主要是由於美國在領先的學術和社區醫院的新資本配置，以及手術量的增加導致一次性銷售額增加。我們對現有客戶中 Focal One HIFU 的更高使用率趨勢感到非常鼓舞，這幫助 EDAP 本季度 HIFU 收入同比強勁增長 63.6%。

There are several factors contributing to increased adoption. As a reminder, Focal One Robotic HIFU is a noninvasive outpatient procedure that demonstrates excellent oncological control with minimal patient downtime and does not require use of surgery or radiation. Focal One continues to demonstrate strong clinical outcomes and favorable economics that are driving both growth and adoption. In fact, Focal One is now a leading and prominent focal therapy in 6 out of the 10 best hospitals for urology according to a recent US news and world report.

有幾個因素有助於提高采用率。需要提醒的是，Focal One 機器人 HIFU 是一種無創門診手術，具有出色的腫瘤控制能力，患者停機時間最短，並且不需要使用手術或放射治療。 Focal One 繼續展現出強勁的臨床成果和有利的經濟效益，推動了增長和採用。事實上，根據最近的一份美國新聞和世界報導，Focal One 現在是 10 家最佳泌尿外科醫院中的 6 家領先且突出的局部療法。

Focal One HIFU is also becoming one of the fastest growing treatments within the category of prostate cancer management. Strong Focal One Robotic HIFU capital sales continue to lead our topline performance with sales of four Focal One units in the US, including the first system placements in the states of both Kansas and West Virginia.

Focal One HIFU 也正在成為前列腺癌治療領域中增長最快的治療方法之一。強勁的 Focal One 機器人 HIFU 資本銷售繼續引領我們的營收業績，在美國銷售了四台 Focal One 設備，包括在堪薩斯州和西弗吉尼亞州部署的第一批系統。

While we continue to see adoption at leading academic and regional cancer centers, we are also proud to announce the recent sale of Focal One to Memorial Sloan-Kettering Cancer Center which is a top-ranked, world-renowned urology institution. While prominent academic urology-focused hospitals continue to be strong proponents of Focal One HIFU therapy, community hospitals and large urology practices are increasingly adopting Focal One HIFU as a necessary treatment option for their prostate cancer patients.

雖然我們繼續看到領先的學術和區域癌症中心採用該技術，但我們也很自豪地宣布最近將Focal One 出售給紀念斯隆-凱特琳癌症中心，該中心是一家頂級、世界知名的泌尿學機構。雖然以泌尿外科為重點的著名學術醫院仍然是 Focal One HIFU 治療的堅定支持者，但社區醫院和大型泌尿外科診所越來越多地採用 Focal One HIFU 作為前列腺癌患者的必要治療選擇。

Procedure growth is also an important metric that we follow closely. As noted, Focal One HIFU procedure volumes in the US experienced robust 85% year-over-year growth in the second quarter. Sequentially, procedure volumes grew 29% in the second quarter of 2023 as compared to the first quarter, representing our third consecutive quarter of double-digit percentage growth. We attribute this acceleration in procedure growth to our strategic investments to grow the Focal One clinical sales team combined with improved reimbursement rates.

程序增長也是我們密切關注的一個重要指標。如上所述，第二季度 Focal One HIFU 手術量在美國同比增長 85%。隨後，2023 年第二季度的手術量較第一季度增長了 29%，代表我們連續第三個季度實現兩位數百分比增長。我們將手術增長的加速歸功於我們對 Focal One 臨床銷售團隊的戰略投資以及報銷率的提高。

While we continue to see favorable impact on demand for higher reimbursement in the US, in July, we were also pleased to announce reimbursement approval in Switzerland for the use of High-Intensity Focused Ultrasound in the treatment of prostate cancer having taken effect on July 1, 2023.

雖然我們繼續看到美國對更高報銷需求的有利影響，但 7 月份，我們還很高興地宣布瑞士批准使用高強度聚焦超聲治療前列腺癌的報銷已於 7 月 1 日生效，2023。

Switzerland is a member of the DACH region including Germany, Austria, and Switzerland with over 100 million combined total inhabitants. Switzerland has many hospitals ranked amongst the best 250 in the world according to Newsweek's The World's Best Hospitals 2023. Included in this list is the University of Zurich, an active prominent Focal One site, and the leading innovation center for HIFU in the country and a member of The League of European Research Universities, placing it among Europe's most prestigious research institutions.

瑞士是 DACH 地區的成員，該地區包括德國、奧地利和瑞士，總人口超過 1 億。根據《新聞周刊》的《2023 年世界最佳醫院》，瑞士有許多醫院躋身世界最佳250 家醫院之列。此名單中包括蘇黎世大學、活躍的著名Focal One 網站、該國領先的HIFU 創新中心和歐洲研究型大學聯盟的成員，使其躋身歐洲最負盛名的研究機構之列。

We have also made commensurate investments in ongoing educational activities including the live broadcasted Focal One procedure performed by Dr. Andre Abreu and Dr. Amir Lebastchi, Assistant Professors of Clinical Urology at the Keck School of Medicine at the University of Southern California, the first institution to acquire and adopt EDAP HIFU technology. In April, we broadcasted this live event worldwide and discussed its success on our last earnings call. A replay of that procedure is still available to view at our website, focalone.com.

我們還對正在進行的教育活動進行了相應的投資，包括由南加州大學凱克醫學院（第一個機構）臨床泌尿外科助理教授 Andre Abreu 博士和 Amir Lebastchi 博士進行的直播 Focal One 手術獲得併採用EDAP HIFU技術。四月，我們在全球範圍內直播了這一活動，並在上次財報電話會議上討論了其成功。該過程的重播仍然可以在我們的網站 focusone.com 上查看。

In April, we had our largest presence ever at the American Urological Association meeting with many productive engagements amongst prominent clinicians, hospital executives, and other stakeholders who validated our leading position in the category of focal therapy.

四月，我們在美國泌尿外科協會會議上進行了有史以來最大規模的出席，與著名臨床醫生、醫院高管和其他利益相關者進行了許多富有成效的交流，他們證實了我們在局部治療領域的領先地位。

As a reminder, there were multiple Focal One scientific abstracts presented by several prestigious institutions including The Martini-Klinik in Hamburg, Germany. The Martini-Klinik Martini clinic has the largest prostate cancer treatment program in the world. The AUA abstract presented by The Martini-Klinik highlighted seven years' experience using Focal One High-Intensity Focused Ultrasound in 164 patients with prostate cancer. All treatments were established as primary therapy, and monitor and definitions followed a very strict protocol. The oncologic outcome showed excellent cancer control with only 7% significant infield recurrence and 91.5% radical treatment-free survival at seven years.

提醒一下，包括德國漢堡的 Martini-Klinik 在內的多家著名機構發表了多份 Focal One 科學摘要。 Martini-Klinik Martini 診所擁有世界上最大的前列腺癌治療項目。 Martini-Klinik 提交的 AUA 摘要強調了使用 Focal One 高強度聚焦超聲治療 164 名前列腺癌患者七年的經驗。所有治療均被確定為主要治療，監測和定義遵循非常嚴格的方案。腫瘤學結果顯示出出色的癌症控制，七年時顯著內野復發率僅為 7%，無根治性治療生存率為 91.5%。

On the functional side, very few complications were reported with 91.5% patients maintaining their baseline urinary continence and 85% maintaining their baseline erectile function. These results were impressive, as we continue to further educate clinicians, patients, and providers on the benefits of Focal One Robotic HIFU.

在功能方面，報告的並發症很少，91.5% 的患者保持基線尿失禁，85% 的患者保持基線勃起功能。這些結果令人印象深刻，我們將繼續向臨床醫生、患者和醫療服務提供者進一步宣傳 Focal One 機器人 HIFU 的優勢。

Additionally, throughout the AUA meeting, EDAP was very busy giving numerous customers their hands-on ability to use Focal One in a simulated prostate ablation procedure. They were able to see in action the robotic positioning system, advanced imaging, and fusion capabilities while setting up a prescribed ablation treatment plan.

此外，在 AUA 會議期間，EDAP 非常忙於向眾多客戶提供在模擬前列腺消融手術中使用 Focal One 的實踐能力。他們能夠在製定規定的消融治療計劃時看到機器人定位系統、先進成像和融合功能的實際應用。

More recently, Focal One was the only focal therapy invited to present and participate in a plenary panel on innovative robotic systems at the preeminent Annual Meeting of the Society of Robotic Surgery held in Melbourne, Australia.

最近，Focal One 是唯一受邀出席在澳大利亞墨爾本舉行的機器人外科學會年會的創新機器人系統全體小組會議的焦點療法。

I'd now like to provide a brief update on our distribution business.

現在我想簡單介紹一下我們的分銷業務。

As previously announced during the first quarter, EDAP received approval from Japan's Pharmaceutical and Medical Devices Agency for commercialization of ExactVu Micro-Ultrasound, enabling EDAP to emerge as a major player in the prostate cancer market in Japan. Japan remains the second largest market for advanced medical device technology with prostate cancer being the most commonly diagnosed cancer in Japanese men with over 100,000 new prostate cancer diagnoses made annually. Following this approval, EDAP had a strong presence at the 110th Annual Meeting of the Japanese Urology Association, which showcased and officially launched ExactVu Micro-Ultrasound in Japan. During the quarter, we sold nine ExactVu units. We continue to see ongoing demand for this differentiated advanced imaging technology that is becoming routinely used in performing targeted biopsies for prostate cancer.

正如之前在第一季度宣布的那樣，EDAP 獲得了日本藥品和醫療器械管理局的 ExactVu 微超聲商業化批准，使 EDAP 成為日本前列腺癌市場的主要參與者。日本仍然是先進醫療設備技術的第二大市場，前列腺癌是日本男性最常診斷的癌症，每年新診斷出的前列腺癌病例超過 100,000 例。獲得批准後，EDAP 在日本泌尿外科協會第 110 屆年會上強勢亮相，在日本展示並正式推出了 ExactVu 微超聲。本季度，我們售出了九台 ExactVu。我們繼續看到對這種差異化先進成像技術的持續需求，該技術正在常規用於前列腺癌的靶向活檢。

In parallel, our Focal One HIFU clinical development programs are progressing well. Last quarter, we reported positive results from the Endo-HIFU-R1 Phase 2 study in deep infiltrating rectal endometriosis, where patients treated with Focal One HIFU experienced measurable improvement across a broad range of debilitating symptoms.

與此同時，我們的 Focal One HIFU 臨床開發項目進展順利。上個季度，我們報告了針對深部浸潤直腸子宮內膜異位症的Endo-HIFU-R1 2 期研究的積極結果，其中接受Focal One HIFU 治療的患者在廣泛的衰弱症狀方面經歷了可測量的改善。

Following these positive results, we are pleased to report that more than 50% of the patients have now been enrolled across six centers in France for our confirmatory Phase 3 comparative double-blind randomized controlled trial. As noted, the primary efficacy endpoint for this 60-patient study is the level of acute pelvic pain as assessed at three months post procedure. If results from the Phase 3 trial mirror those from the Phase 2 trial, we would assess strong clinical evidence to support Focal One HIFU as a new effective less-invasive first-line treatment for deep infiltrating rectal endometriosis.

繼這些積極結果之後，我們很高興地報告，法國六個中心已有超過 50% 的患者入組，參加我們的驗證性 3 期比較雙盲隨機對照試驗。如前所述，這項 60 名患者參與的研究的主要療效終點是術後三個月評估的急性盆腔疼痛水平。如果3 期試驗的結果與2 期試驗的結果一致，我們將評估強有力的臨床證據，以支持Focal One HIFU 作為一種新的有效的微創一線治療方法，治療深部浸潤直腸子宮內膜異位症。

Given how few treatment options are available, Focal One HIFU could become an important new treatment option, enabling patients to avoid the known morbidity and complications often associated with surgical resection of the bowel or rectum.

鑑於可用的治療選擇很少，Focal One HIFU 可能成為一種重要的新治療選擇，使患者能夠避免通常與腸道或直腸手術切除相關的已知發病率和並發症。

Looking ahead, we expect both growing demand for new Focal One HIFU systems as well as increased utilization amongst our existing customers. With EUR51.3 million or USD56 million in cash and short-term investments and de minimis debt, we remain well positioned to invest in our sales, marketing, education, and clinical development activities to support the continued expansion of Focal One HIFU. The strategic and ongoing investments made in the first half of 2023 will support the increased demand in the US marketplace for our technology. With our growing active pipeline for new business, we anticipate continued strong adoption of Focal One technology platform with respect to new system placements and increasing utilization.

展望未來，我們預計對新型 Focal One HIFU 系統的需求將會不斷增長，並且我們現有客戶的利用率也會提高。憑藉 5130 萬歐元或 5600 萬美元的現金和短期投資以及微額債務，我們仍然能夠很好地投資於我們的銷售、營銷、教育和臨床開發活動，以支持 Focal One HIFU 的持續擴張。 2023 年上半年進行的戰略和持續投資將支持美國市場對我們技術不斷增長的需求。隨著我們新業務的活躍渠道不斷增長，我們預計 Focal One 技術平台在新系統佈局和利用率方面將繼續得到廣泛採用。

With that, I will now pass the call over to Ken to review the second-quarter financial performance. Ken?

現在，我將把電話轉給肯，讓他審查第二季度的財務業績。肯？

Thank you, Ryan, and good morning, everyone. Please note that all figures except for percentages are in euros. For conversion purposes, our average euro dollar exchange rate was 1.0871 for the second quarter of 2023.

謝謝瑞安，大家早上好。請注意，除百分比外的所有數字均以歐元為單位。出於換算目的，我們 2023 年第二季度的平均歐元兌美元匯率為 1.0871。

Total revenue for the same second quarter of 2023 was EUR14.3 million, an increase of almost 1% as compared to total revenue of EUR14.2 million for the same period in 2022, a new record level for a second quarter.

2023 年第二季度的總收入為 1,430 萬歐元，較 2022 年同期的 1,420 萬歐元的總收入增長近 1%，創第二季度新紀錄。

Looking at revenue by division, total revenue in the HIFU business for the second quarter was EUR4.9 million as compared to EUR3 million for the second quarter of 2022, a 63.6% increase year over year. As referenced, the increase was driven by selling four Focal One units in the second quarter of 2023 versus one unit sold in the second quarter of 2022.

按部門劃分的收入來看，第二季度 HIFU 業務的總收入為 490 萬歐元，而 2022 年第二季度為 300 萬歐元，同比增長 63.6%。如前所述，這一增長是由於 2023 年第二季度銷售了 4 台 Focal One，而 2022 年第二季度銷售了 1 台。

Total revenue in the LITHO business for the second quarter was EUR2.2 million as compared to EUR3.6 million for the second quarter of 2022. The year-over-year decline in LITHO revenue was mainly attributed to six less units sold year over year, as well as supply chain constraints with a few key suppliers during the quarter.

第二季度 LITHO 業務總收入為 220 萬歐元，而 2022 年第二季度為 360 萬歐元。LITHO 收入同比下降的主要原因是銷量同比減少了 6 台以及本季度少數主要供應商的供應鏈限制。

Total revenue in the distribution business for the second quarter was EUR7.2 million as compared to EUR7.6 million for the second quarter of 2022. The decline in distribution revenue was primarily driven by nine ExactVu units sold during the second quarter of 2023 as compared to 15 units sold during the second quarter of 2022.

第二季度分銷業務總收入為 720 萬歐元，而 2022 年第二季度為 760 萬歐元。分銷收入下降的主要原因是 2023 年第二季度售出 9 台 ExactVu 設備。 2022 年第二季度售出15套。

Gross profit for the second quarter was EUR5.7 million compared to EUR6.2 million for the year-ago period. Gross profit margin on net sales was 39.6% in the second quarter compared to 43.8% in the year-ago period. The decrease in gross profit margin year over year was primarily due to distribution product mix, global inflationary price pressure on components with increased manufacturing costs, and continued investments in our US service and clinical application organizations to support HIFU in long-term revenue growth.

第二季度毛利潤為 570 萬歐元，去年同期為 620 萬歐元。第二季度淨銷售額毛利率為 39.6%，而去年同期為 43.8%。毛利率同比下降主要是由於分銷產品組合、全球通脹價格壓力導致製造成本增加，以及我們對美國服務和臨床應用機構的持續投資以支持 HIFU 的長期收入增長。

Operating expenses were EUR9.9 million for the second quarter compared to EUR6.6 million for the same period of 2022. The increase in operating expenses was primarily due to the strategic and planned buildout of the US team and commercial infrastructure, variable compensation, and increased marketing activities.

第二季度運營費用為 990 萬歐元，而 2022 年同期為 660 萬歐元。運營費用增加主要是由於美國團隊和商業基礎設施的戰略和計劃建設、可變薪酬和增加營銷活動。

Operating loss for the second quarter was EUR4.2 million compared to an operating loss of EUR0.4 million in the second quarter of 2022. Excluding the impact of non-cash, share-based compensation, operating loss for the second quarter would have been EUR3.1 million compared to an operating loss of EUR0.1 million in Q2 2022. Net loss for the second quarter was EUR4.7 million or EUR0.13 per diluted share as compared to net income of EUR1.8 million or EUR0.05 per diluted share in the year-ago period.

第二季度的運營虧損為 420 萬歐元，而 2022 年第二季度的運營虧損為 40 萬歐元。如果排除非現金、股權激勵的影響，第二季度的運營虧損將是310 萬歐元，而2022 年第二季度的運營虧損為10 萬歐元。第二季度淨虧損為470 萬歐元，即稀釋後每股0.13 歐元，而淨利潤為180 萬歐元，即0.05 歐元去年同期稀釋後每股收益。

Total cash and cash equivalents at the end of Q2 was EUR51.3 million or USD56 million as compared to EUR58.3 million or USD63.4 million at the end of Q1 2023.

第二季度末的現金和現金等價物總額為 5130 萬歐元或 5600 萬美元，而 2023 年第一季度末為 5830 萬歐元或 6340 萬美元。

We continue to monitor cash flow closely as we invest for long-term business growth while also remaining cognizant of short-term financial performance. Through our strategic investments, we are confident in realizing the extraordinary opportunity with Focal One HIFU to fundamentally change the emerging treatment paradigm for the management of prostate cancer.

我們在投資長期業務增長的同時，繼續密切監控現金流，同時也保持對短期財務業績的認識。通過我們的戰略投資，我們有信心利用 Focal One HIFU 實現這一非凡機遇，從根本上改變前列腺癌管理的新興治療模式。

Those are our key financial highlights for the second quarter of 2023.

這些是我們 2023 年第二季度的主要財務亮點。

And with that, I'd like to turn the call back to Ryan. Ryan?

說到這裡，我想把電話轉回給瑞安。瑞安？

Thank you, Ken.

謝謝你，肯。

In summary, our second-quarter results continue to reinforce our confidence in the growing demand for Focal One as well as validating our strategy and execution to drive education and adoption. Sales and unit placements of Focal One are growing along with increased Focal One HIFU procedures.

總之，我們第二季度的業績繼續增強了我們對 Focal One 不斷增長的需求的信心，並驗證了我們推動教育和採用的戰略和執行力。隨著 Focal One HIFU 手術的增加，Focal One 的銷量和單位安置也在增長。

In closing, we remain optimistic about the remainder of 2023. I would like to thank the entire EDAP team for their dedication and hard work that is driving increased awareness amongst clinicians and patients of Focal One HIFU as an important and growing treatment option for prostate cancer management.

最後，我們對 2023 年剩餘時間保持樂觀。我要感謝整個 EDAP 團隊的奉獻和辛勤工作，他們提高了臨床醫生和患者對 Focal One HIFU 作為前列腺癌重要且不斷增長的治療選擇的認識管理。

We look forward to sharing our progress with you again in the fall, and I will now turn it back over to the operator for questions. Operator?

我們期待在秋季再次與您分享我們的進展，現在我將把它轉交給運營商以供提問。操作員？

Thank you. The floor is now open for questions. (Operator Instructions) Michael Sarcone at Jefferies.

謝謝。現在可以提問。 （操作員說明）Jefferies 的 Michael Sarcone。

So first one is just on the four Focal One system sales in the US. I guess, can you just talk more about the sales funnel and how demand is shaping up there, and maybe how you think the trajectory of the system placements might shake out through the remainder of the year?

第一個是關於美國的四台 Focal One 系統的銷售情況。我想，您能否更多地談談銷售漏斗以及那裡的需求是如何形成的，也許您認為系統佈局的軌跡在今年剩餘時間內可能會發生變化？

Yeah. So we continue to see our active pipeline growing. As noted, we have added additional headcount. We're building a broader coverage model. And again, our pipeline continues to grow. We have a number of projects in play, and we expect to have notable sales in both Q3 and 4.

是的。因此，我們繼續看到我們的活躍管道不斷增長。如前所述，我們增加了額外的員工人數。我們正在建立一個更廣泛的覆蓋模型。同樣，我們的管道繼續增長。我們有許多項目正在進行中，我們預計第三季度和第四季度都有可觀的銷售。

So we would say openly, the back half of the year should be a stronger portion of the year. So currently, again, we've got our team active. We have some deals in process, and we're excited to close out both Q3 and Q4.

因此，我們可以公開地說，今年下半年應該是一年中表現強勁的部分。因此，目前我們的團隊再次活躍起來。我們正在進行一些交易，我們很高興能夠完成第三季度和第四季度。

Great. Thanks for the color. And maybe just a follow-up on that. If you had about 11 system placements in 1H just based on your commentary, that means we could see above that for 2H?

偉大的。謝謝你的顏色。也許只是後續行動。如果僅根據您的評論，您在 1H 中就有大約 11 個系統放置，這意味著我們可以在 2H 中看到上面的內容？

Definitely I would say above that for sure. And again, we continue to grow the commercial structure. And with that, we broaden the number of hospitals that, as I would say, in our active pipeline.

我肯定會在上面說。再次，我們繼續擴大商業結構。由此，我們擴大了我們正在建設的醫院數量。

That's really helpful. Thanks, Ryan. And then just last one for me. 85% strategic growth in the US seems pretty strong. Can you just give a little more color on what you're seeing in terms of the utilization environment even if its trends and procedures per system? And is there any way you can quantify or ballpark the number of procedures you're seeing either quarterly or annualized in the US?

這真的很有幫助。謝謝，瑞安。然後是我的最後一個。美國 85% 的戰略增長似乎相當強勁。您能否就您在使用環境方面所看到的情況提供更多的信息，即使它的趨勢和每個系統的過程？有什麼方法可以量化或估算美國每季度或每年看到的手術數量嗎？

Yeah, Michael, we don't give out our actual procedure numbers. What I would say is we continue to see increased utilization both in our installed base customers and even new customers that are just acquiring the technology. We track metrics to include time to first case, time for case 1 to case 10 and beyond. So I think we're seeing the impact our clinical sales team is making, but we're also seeing the consumer that is patients looking for other options beyond just surgery and radiation.

是的，邁克爾，我們不會給出實際的程序編號。我想說的是，我們繼續看到我們的已安裝客戶群甚至剛剛獲得該技術的新客戶的利用率不斷提高。我們跟踪的指標包括第一個案例的時間、案例 1 到案例 10 以及更多案例的時間。因此，我認為我們看到了我們的臨床銷售團隊所產生的影響，但我們也看到了消費者，即患者正在尋找手術和放射之外的其他選擇。

And again, I think in our message, we have a noninvasive treatment option for men diagnosed with prostate cancer. So we continue to create more market awareness. And I think that also will breed additional momentum into our story.

再次，我認為在我們的信息中，我們為診斷患有前列腺癌的男性提供了一種非侵入性治療選擇。所以我們繼續創造更多的市場意識。我認為這也將為我們的故事帶來更多動力。

Great.

偉大的。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

I just wanted to follow up just one more question on placement expectations in the second half of the year. Ryan, I was hoping you could comment on regular seasonality trends. I know I asked about this last call, but I was looking for just an update if you expect that Q3 being a summer month or US seasonality more pronounced as sometimes US seasonality more pronounced as well with the majority of those greater than 11 implants in the fourth quarter as an expectation?

我只想再跟進一個關於下半年安置預期的問題。瑞安，我希望你能評論一下常規的季節性趨勢。我知道我問過最後一次電話會議，但我只是在尋找更新，如果您預計第三季度是夏季，或者美國的季節性因素更加明顯，因為有時美國的季節性因素也更加明顯，而且大多數植入數量超過11 次第四季度是預期嗎？

Yeah, Frank, we don't see, at least as we're going through the quarter, the seasonality we would typically experience in, say, a summer slowdown. We don't see that. I think we see the momentum building. And as mentioned earlier, again, our pipeline continues to develop and grow. We've got our team head down and focused, and I would expect a stronger second half of the year again. So I don't see the slower Q3 that may be common for other companies or other technologies. I think we have that momentum as we walk into the back half of the year. So I think that's where we stand.

是的，弗蘭克，至少在我們整個季度中，我們沒有看到我們通常會經歷的季節性，例如夏季經濟放緩。我們沒有看到這一點。我認為我們看到了勢頭的增強。正如前面提到的，我們的產品線繼續發展和壯大。我們的團隊已經低頭並專注，我預計今年下半年會再次變得更加強勁。因此，我沒有看到其他公司或其他技術可能常見的第三季度較慢的情況。我認為，當我們進入今年下半年時，我們就有了這種勢頭。所以我認為這就是我們的立場。

Got it. That's helpful. And then on the procedure side, I know one thing you've spoken about the past is related to the disposable ASP with the renewed reimbursement at the beginning of this year and maybe having a little bit of flexibility to increase that ASP or slowly increase that ASP over a number of years. Can you maybe update us on that dynamic and whether or not you still think there's more room to go on the ASP-related disposables?

知道了。這很有幫助。然後在程序方面，我知道您過去談到的一件事與今年年初更新報銷的一次性 ASP 有關，也許有一點靈活性來增加 ASP 或慢慢增加ASP 已有多年曆史。您能否向我們介紹一下最新動態以及您是否仍然認為與 ASP 相關的一次性用品還有更多空間？

It's a great question. I would say, yes, there is an opportunity. And I would say, historically, since I've been in the company, the ASP on procedures has gone up. We continue to look at it closely. We work very closely with our legacy customers, and we've had some price increases notably with certain accounts and continue to see that average -- call it, average sales price per procedure going up.

這是一個很好的問題。我會說，是的，有機會。我想說，從歷史上看，自從我進入公司以來，程序的平均售價一直在上升。我們繼續密切關注。我們與我們的老客戶密切合作，我們的價格有所上漲，特別是某些客戶的價格上漲，並且繼續看到平均——稱之為，每個程序的平均銷售價格上漲。

Now, again, we pay close attention to that, and we monitor. And that also plays true for the new accounts that acquire our technology. So I'd say we would say there's room to grow for sure. And again, I think we enjoy some additional advantages from the reimbursement that's in place.

現在，我們再次密切關注並監控這一點。對於獲得我們技術的新客戶來說也是如此。所以我想說我們肯定有增長的空間。再說一次，我認為我們從現有的報銷中獲得了一些額外的優勢。

Got it. Thanks for the color. I'll stop there.

知道了。謝謝你的顏色。我就到此為止。

Jason Bednar, Piper Sandler.

傑森·貝德納，派珀·桑德勒。

I wanted to follow-up just really on the Focal One placement. I'm sorry to ask another one here, but I wanted to check to see just how or whether the rate environment and the broader macro dynamics out there just influencing the attitude of hospitals, both on the large academic side and the community centers. Are your prospects moving forward at the same pace as what you've seen historically?

我想對 Focal One 的安置進行真正的跟進。我很抱歉在這裡問另一個問題，但我想檢查一下利率環境和更廣泛的宏觀動態如何或是否會影響醫院的態度，無論是在大型學術方面還是社區中心。您的前景是否以與您歷史上看到的相同的速度前進？

I may know the answer just based on what you responded to Frank's question just there regarding business strength here in the third quarter, but I just wanted to check with you if that's the dynamic at all that's influencing conversations you're having and whether your business actually might even be stronger than what you're seeing in the third quarter, if not for some of these macro factors.

我可能僅根據您對弗蘭克關於第三季度業務實力的問題的回答就知道答案，但我只是想與您核實一下這是否是影響您正在進行的對話的動態以及您的業務是否如果不是因為其中一些宏觀因素，實際上甚至可能比第三季度看到的還要強勁。

Yeah, we don't really see any headwinds related to that. I know with interest rates going the direction they're going, we have not seen the impact on that. We are in a category of disruptive capital equipment. However, we're also in the category of strategic capital. So again, hospitals, as you know, routinely buy capital equipment. But again, adding Focal One and adding focal therapy or, in our case, robotic focal HIFU, we see that as a strategic initiative, and we work very closely with our hospital customers as we move through that buying process.

是的，我們確實沒有看到任何與此相關的阻力。我知道隨著利率朝著目前的方向發展，我們還沒有看到對此的影響。我們屬於顛覆性資本設備類別。然而，我們也屬於戰略資本的範疇。正如您所知，醫院通常會購買固定設備。但同樣，添加 Focal One 並添加焦點治療，或者在我們的例子中，添加機器人焦點 HIFU，我們將其視為一項戰略舉措，並且在完成購買流程時，我們與醫院客戶密切合作。

So again, I don't put us in the category of operational capital. We are strategic capital. And again, you can back it up in the state of, hey, it's clinically necessary to offer something today, we believe, in focal therapy. It's also strategic for a hospital, and it can bring strong economic reward. So we have that in our narrative.

再說一次，我不把我們歸入運營資本的範疇。我們是戰略資本。再說一次，你可以在這樣的狀態下支持它，嘿，我們相信，今天在臨床上有必要在局部治療中提供一些東西。這對醫院來說也具有戰略意義，可以帶來豐厚的經濟回報。所以我們的敘述中有這一點。

Jason, the only other thing I'd add regarding your question is we have seen in the hospital environment in the purchase environment, they're taking time in approving their purchases, okay? We had a few systems get stuck in the buying process in Q2 that we see going through in Q3. So if anything, they're just taking a really good look at these purchases before they buy them.

傑森，關於你的問題我要補充的唯一一件事是我們在醫院環境中的購買環境中看到，他們需要時間來批准他們的購買，好嗎？我們有一些系統在第二季度的購買過程中陷入困境，我們看到在第三季度也會遇到這種情況。因此，如果有的話，他們只是在購買之前仔細查看這些購買的產品。

Okay. So maybe just a longer sales cycle but not actually influencing the yes or no decision.

好的。因此，也許只是更長的銷售週期，但實際上並不會影響是或否的決定。

Exactly.

確切地。

Perfect. Okay. That's very helpful. I also wanted to ask Ken on the gross margins. They're a little bit below what we are looking for. I know you called out some of the factors that are influencing some of that softness. But maybe if you could just add any more color on the distribution side. That was probably the bigger miss in our model. But then any other directional guidance you can give?

完美的。好的。這非常有幫助。我還想問 Ken 關於毛利率的問題。它們比我們要尋找的要低一些。我知道你指出了一些影響這種柔軟度的因素。但也許你可以在分配方面添加更多顏色。這可能是我們模型中更大的失誤。那麼您還能提供其他方向性指導嗎？

I know you don't offer formal guidance, but any color on how to think about whether it's segment or company-wide gross margins going forward and whether we're at a trough here or if we need to contemplate additional service investments that may still then weigh on those gross margins going forward.

我知道你沒有提供正式的指導，但任何關於如何思考未來的細分市場或全公司毛利率以及我們是否處於低谷或者我們是否需要考慮可能仍然存在的額外服務投資的任何顏色然後權衡未來的毛利率。

Yeah, so good question, Jason. The one big thing was our distribution mix this quarter. So I look at that as timing related. We're always going to continue to make investments to grow the company forward. Our operating expenses are continuing to -- continue to grow, but we're monitoring them closely, right? We really need to invest in areas that's really going to drive the sales funnel.

是的，很好的問題，傑森。一件大事是我們本季度的分銷組合。所以我認為這與時間有關。我們將始終繼續進行投資以推動公司發展。我們的運營費用正在繼續增長，但我們正在密切監控它們，對吧？我們確實需要投資於真正能夠推動銷售渠道的領域。

So as well as on the COGS line, we've got to build to support to get the tools installed and serviced as well. We did see a little bit of inflationary price pressures that we're monitoring. Obviously, we're looking at solutions to that. And then, just going forward, I do see when the mix gets stronger, as Ryan noted, we do expect Focal One to pick up here in the second half. And then, as we noted earlier in the year too, we increased our prices as well, our list prices for Focal One. So I do see margins picking back up versus where they ended up in Q2.

因此，與 COGS 生產線一樣，我們還必須建立支持來安裝和維護工具。我們確實看到了我們正在監測的一些通脹價格壓力。顯然，我們正在尋找解決方案。然後，就在接下來，我確實看到混合動力何時變得更強，正如 Ryan 指出的那樣，我們確實預計 Focal One 在下半場會有所回升。然後，正如我們在今年早些時候指出的那樣，我們也提高了價格，即 Focal One 的標價。因此，我確實看到利潤率較第二季度有所回升。

All right. Very helpful.

好的。很有幫助。

Swayampakula Ramakanth, H.C. Wainwright.

斯瓦安帕庫拉·拉瑪坎特 (Swayampakula Ramakanth)，H.C.溫賴特。

This is RK from H.C. Wainwright. With increasing volume growth, as you stated, about 85% year over year and 29% quarter over quarter, when would you expect this to be reflected in your consumables' revenue growth? Just trying to get an idea in terms of the cadence of that revenue flow?

我是 H.C. 的 RK。溫賴特。正如您所說，隨著銷量的增長，同比增長約 85%，環比增長 29%，您預計這何時會反映在消耗品的收入增長中？只是想了解收入流的節奏嗎？

Yeah, RK. First thing, again, we build program. So when the system is placed, there's a training event for the team. We call it an onboarding process. And so that can take some time. It really depends on each hospital, their individual. But we do everything to shorten that timeline.

是的，RK。首先，我們再次構建程序。因此，當系統安裝完畢後，就會為團隊舉辦一次培訓活動。我們稱之為入職流程。這可能需要一些時間。這實際上取決於每家醫院及其個人。但我們會盡一切努力縮短這個時間。

So I think we'll see more of a notable impact over time certainly as we place more systems. But also, as systems get used to using the technology and have clinical use and patients treated clinically and successfully, I think just organically, you're going to see an increase in same-store sales. And we have a dedicated team, both clinical sales team and applications team, that work very closely with our customers.

因此，我認為隨著時間的推移，隨著我們放置更多的系統，我們肯定會看到更多顯著的影響。而且，隨著系統習慣於使用該技術並進行臨床使用，並且患者得到臨床和成功的治療，我認為，從有機角度來看，您將看到同店銷售額的增長。我們擁有一支專門的團隊，包括臨床銷售團隊和應用團隊，與我們的客戶密切合作。

So I think as you look outward, it takes a while. But notably, based on percentage increase, we see an increase of procedures. And that is both in our legacy accounts as well as we are placing more systems. So I think over time, that will be something to look closer at. And again, we are very focused on our procedures as noted, and we continue to resource that team accordingly.

所以我認為當你向外看時，這需要一段時間。但值得注意的是，根據百分比增長，我們看到程序有所增加。這既存在於我們的遺留帳戶中，也存在於我們正在放置的更多系統中。所以我認為隨著時間的推移，這將是值得仔細研究的事情。再次強調，我們非常關注我們的程序，我們將繼續為該團隊提供相應的資源。

Just trying to get an additional color on the sales cycle timing. With reimbursement in place, and you stated in an answer to the previous question that the sales cycle is becoming a little bit longer because they're trying to take a closer look, any additional color why that is? So is that more on the financing side of things or -- I'm just trying to understand what is making that sales cycle longer. Is it more administrative stuff? Anything at all?

只是想在銷售週期時間上獲得額外的色彩。報銷到位後，您在回答上一個問題時表示，銷售週期變得有點長，因為他們試圖仔細觀察，有任何其他顏色嗎？這是為什麼？那麼，這更多是在融資方面，還是——我只是想了解是什麼導致了銷售週期更長。是更多行政事務嗎？有什麼嗎？

Yeah, it would be fair to say today, hospitals that are looking at making investments in new innovative capital equipment, they typically go through their own pro forma analysis. So those pro forma analyses vary by institution. Some institutions move faster than others. Some may slow down. They just want to do their due diligence. And, again, we're adding -- in many cases, it's a new revenue enhancing service line. And with that said, they just want to look at the numbers and run some calculations.

是的，公平地說，今天，正在考慮投資新的創新資本設備的醫院通常會進行自己的形式分析。因此，這些形式分析因機構而異。有些機構比其他機構行動得更快。有些可能會放慢速度。他們只是想盡職調查。而且，我們再次添加——在許多情況下，這是一條新的增收服務線。話雖如此，他們只是想看看數字並進行一些計算。

As we said in the past, we have favorable economics and typically when we go through that process, it leads up ultimately to sale. So again, I think it varies by institution as Ken had referenced. And it's not for every hospital. I think -- some will always move faster than others. But we're accustomed to going through that process, and we pay a lot of attention to it.

正如我們過去所說，我們有良好的經濟效益，通常當我們經歷這個過程時，它最終會導致銷售。再說一次，我認為正如肯所提到的那樣，它因機構而異。而且並不適合每家醫院。我認為——有些人總是比其他人行動得更快。但我們已經習慣了這個過程，並且非常關注它。

If it slows down, we're active with our customers, kind of working shoulder to shoulder to make sure we answer any questions they have or we can help them fully appreciate and understand the financial return from their investment.

如果速度放緩，我們會積極與客戶合作，並肩工作，以確保我們回答他們的任何問題，或者我們可以幫助他們充分欣賞和理解投資的財務回報。

Thanks for that. And then on the Swiss reimbursement, with that in place, how long do you think it could take for it to reflect on your sales? And how big is the Swiss market as [Swiss are] associated countries along with Swiss?

感謝那。然後，在瑞士報銷方面，您認為它需要多長時間才能反映在您的銷售額上？作為與瑞士相關的國家，瑞士的市場有多大？

So as noted, we -- first off, Switzerland is a country with essentially three languages, right? You have the German side, Zurich, and the Cantons, the French side. And then you even have an area of Italian influence. And so I think back to the reimbursement, we've been active in Switzerland over the years. As mentioned, we have a very prominent program at University of Zurich with Professor Daniel Eberli. And we have had some -- and we have other systems placed in the Geneva market, et cetera.

如前所述，我們——首先，瑞士是一個基本上擁有三種語言的國家，對吧？德國方面是蘇黎世，而各州則是法國方面。然後你甚至還有一個受意大利影響的地區。所以我回想一下報銷問題，多年來我們一直在瑞士積極開展工作。如前所述，我們在蘇黎世大學有一個非常著名的項目，由 Daniel Eberli 教授主持。我們已經有一些系統，並且我們還在日內瓦市場上放置了其他系統，等等。

So in order to really say how big the market is, I mean, there's a handful of hospitals that are well-known and prominent, and some of those we're actively working with. I can't give you a hard number, but I would say this. Our sales teams are active in the market. We know our customer base, both the legacy base and our target customers, and we're resourced well to go after that business.

因此，為了真正說出市場有多大，我的意思是，有一些知名且著名的醫院，其中一些我們正在積極合作。我無法給你一個確切的數字，但我會這麼說。我們的銷售團隊活躍於市場。我們了解我們的客戶群，包括傳統客戶群和目標客戶，並且我們擁有充足的資源來發展該業務。

And I'm excited. I think this is notable in a country that is small. Switzerland is not a big country but a country that has influence in Europe.

我很興奮。我認為這對於一個小國來說是值得注意的。瑞士不是一個大國，但卻是一個在歐洲有影響力的國家。

So last question from me. On the LITHO business, you stated there were some supply chain issues. Is that pretty much limited to the LITHO business or can it bleed into other divisions as well? And how long do you think the supply chain issue would last within the LITHO business?

這是我的最後一個問題。關於LITHO業務，您提到存在一些供應鏈問題。這很大程度上僅限於 LITHO 業務，還是也可以滲透到其他部門？您認為光刻業務中的供應鏈問題會持續多久？

Yeah. So the supply chain is -- and it's not so much related to us, it's the componentry that they would bring together or purchase alongside of our proprietary lithotripsy technologies. So I don't think it's a long-term thing. In fact, we -- those sales are just delayed until they have the ability to purchase the other components that work alongside our lithotripsy technology. And I don't see really any spillover into any other areas of our business today as stated today.

是的。因此，供應鏈與我們沒有太大關係，而是他們將與我們專有的碎石技術一起組裝或購買的組件。所以我認為這不是一個長期的事情。事實上，我們只是推遲了這些銷售，直到他們有能力購買與我們的碎石技術配合使用的其他組件。正如今天所說，我並沒有看到任何溢出效應會滲透到我們今天業務的任何其他領域。

So again, I think it just -- we had some sales that were ready, but they need to get the additional components added as noted. And we don't see any impact in our other distribution business at this point.

再說一次，我認為這只是——我們已經準備好了一些銷售，但他們需要按照說明添加額外的組件。目前我們還沒有看到我們的其他分銷業務受到任何影響。

At this time, I'd like to turn the floor back over to Mr. Rhodes for closing comments.

現在，我想把發言權交還給羅茲先生以供結束髮言。

I want to thank all who participated in today's call. As a reminder, we will be presenting in New York at both the Morgan Stanley and H.C. Wainwright investment conferences in September. In November, we plan to participate in the Jefferies Global Healthcare Conference in London, and we look forward to speaking to all of you again in November on our third-quarter earnings.

我要感謝所有參加今天電話會議的人。提醒一下，我們將在紐約的摩根士丹利和 H.C.九月溫賴特投資會議。 11 月，我們計劃參加在倫敦舉行的傑富瑞全球醫療保健會議，我們期待在 11 月再次與大家討論我們的第三季度收益。

Thank you.

謝謝。

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.

女士們、先生們，感謝您的參與。今天的活動到此結束。此時，您可以斷開線路或註銷網絡廣播，享受剩下的一天。