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Operator
Operator
Greetings, and welcome to the EDAP TMS first-quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions)
您好,歡迎來到 EDAP TMS 2023 年第一季度收益電話會議。此時,所有參與者都處於只聽模式。正式介紹後將進行簡短的問答環節。 (操作員說明)
As a reminder, this conference is being recorded.
提醒一下,這次會議正在錄製中。
It is now my pleasure to introduce your host, John Fraunces, Managing Director of LifeSci Advisors. Thank you. Please go ahead.
現在我很高興向您介紹主持人,LifeSci Advisors 的常務董事 John Fraunces。謝謝。請繼續。
John Fraunces - IR
John Fraunces - IR
Good morning. Thank you for joining us for the EDAP TMS first-quarter 2023 financial and operating results conference call. On today's call, we'll hear from Ryan Rhodes, Chief Executive Officer; and François Dietsch, Chief Financial Officer; and Ken Mobeck, Chief Financial Officer of the US Subsidiary.
早上好。感謝您加入我們的 EDAP TMS 2023 年第一季度財務和運營業績電話會議。在今天的電話會議上,我們將聽取首席執行官 Ryan Rhodes 的講話;首席財務官 François Dietsch;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.
在我們開始之前,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。此類陳述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陳述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所述的因素。
I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?
我現在想把電話轉給 EDAP 的首席執行官 Ryan Rhodes。賴安?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Thank you, John, and good morning, everyone. I will start today's call by providing highlights from the first 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。我將通過提供 2023 年第一季度的亮點來開始今天的電話會議,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。
After reporting a record fourth quarter, I'm pleased to note that our strong business execution has continued into 2023, reporting our strongest-ever first-quarter revenue performance. In Q1 2023, we recorded revenue of EUR14.8 million or USD15.9 million, which is a year-over-year increase of 13.8% over the first quarter of 2022. Focal One Robotic HIFU sales continue to drive our strong topline performance. During this last quarter, we were successful in placing seven Focal One units, including six equipment sales and one operating lease.
在報告創紀錄的第四季度後,我很高興地註意到,我們強勁的業務執行力一直持續到 2023 年,報告了我們有史以來最強勁的第一季度收入表現。 2023 年第一季度,我們的收入為 1480 萬歐元或 1590 萬美元,比 2022 年第一季度同比增長 13.8%。Focal One Robotic HIFU 的銷售繼續推動我們強勁的營收表現。在上一季度,我們成功安置了七個 Focal One 單位,包括六個設備銷售和一個經營租賃。
One of the noted placements included UCLA Medical Center located in Los Angeles, California. With the addition of UCLA, we have now placed Focal One Robotic HIFU systems at each and every university of California academic teaching hospital. In addition, last quarter, we placed our first Focal One systems in the states of Minnesota and Tennessee, reflecting our expanding and growing geographical presence across the US.
其中一項著名的安置包括位於加利福尼亞州洛杉磯的加州大學洛杉磯分校醫療中心。隨著加州大學洛杉磯分校的加入,我們現在已將 Focal One 機器人 HIFU 系統安裝在加州大學的每一所學術教學醫院。此外,上個季度,我們在明尼蘇達州和田納西州放置了我們的第一個 Focal One 系統,反映了我們在美國不斷擴大和增長的地域影響力。
Lastly, we placed a Focal One system at Santa Barbara Cottage Hospital and we also placed our first Focal One system at Kaiser Permanente Hospital. As market demand for Focal One HIFU technology continues to grow, we are pleased to note that more community and hospitals are adopting our technology. Not surprisingly, the leading academic urology-focused hospitals were amongst the first adopters of Focal One Robotic HIFU.
最後,我們在 Santa Barbara Cottage 醫院安裝了一個 Focal One 系統,我們還在 Kaiser Permanente 醫院安裝了我們的第一個 Focal One 系統。隨著市場對 Focal One HIFU 技術的需求不斷增長,我們很高興地註意到越來越多的社區和醫院正在採用我們的技術。毫不奇怪,領先的泌尿科學術醫院是 Focal One 機器人 HIFU 的首批採用者之一。
We now see a growing interest in Focal One technology in large community urology practices, indicating market demand is likely to increase as we further penetrate this key target market segment. An account like Kaiser, which is a leader in integrated managed care, further validates that HIFU is part of a comprehensive approach to prostate cancer care. We believe that the continued expansion of Focus One Robotic HIFU amongst academic medical centers, community hospitals, and integrated health systems demonstrates the value that this treatment option provides an any care setting for the most common cancer amongst men.
我們現在看到大型社區泌尿外科實踐對 Focal One 技術的興趣越來越大,這表明隨著我們進一步滲透到這一關鍵目標市場領域,市場需求可能會增加。像 Kaiser 這樣的帳戶,它是綜合管理護理的領導者,進一步驗證了 HIFU 是前列腺癌護理綜合方法的一部分。我們相信,Focus One 機器人 HIFU 在學術醫療中心、社區醫院和綜合衛生系統中的持續擴展證明了這種治療選擇為男性最常見的癌症提供任何護理環境的價值。
As noted on prior calls, a significant increase in CMS reimbursement for hospitals performing a Focal One procedure went into effect at the beginning of 2023. More favorable ROI economics compel hospitals to invest in Focal One HIFU as a necessary treatment option for a subset of patients diagnosed with prostate cancer. We expect this dynamic to help us maintain momentum throughout 2023 and beyond.
正如之前的電話所述,執行 Focal One 手術的醫院的 CMS 報銷顯著增加於 2023 年初生效。更有利的投資回報率經濟學迫使醫院投資 Focal One HIFU 作為部分患者的必要治療選擇被診斷出患有前列腺癌。我們希望這種動態能夠幫助我們在整個 2023 年及以後保持勢頭。
Going forward, we also anticipate continued reimbursement expansion from commercial payers, who often follow CMS's lead in determination of policy. While more favorable reimbursement is clearly an important factor in providing access to Focal One HIFU technology, we also believe that generation of high-quality patient data and treatment outcomes through rigorous clinical studies is an integral part of driving long-term demand for our Robotic HIFU technology.
展望未來,我們還預計商業付款人將繼續擴大報銷範圍,他們通常會跟隨 CMS 的領導來確定政策。雖然更優惠的報銷顯然是提供 Focal One HIFU 技術的一個重要因素,但我們也相信,通過嚴格的臨床研究生成高質量的患者數據和治療結果是推動我們的機器人 HIFU 長期需求的一個組成部分技術。
During the first quarter, we announced positive results from two clinical trials and studies, one in endometriosis and the other in prostate cancer. The principal investigators for both studies were well-recognized, key thought leaders from leading international academic centers. We were pleased to note that the results from each trial clearly underscore the safety, efficacy, and additional symptom and quality-of-life benefits of Focal One HIFU therapy.
在第一季度,我們宣布了兩項臨床試驗和研究的積極結果,一項針對子宮內膜異位症,另一項針對前列腺癌。這兩項研究的主要研究者都是來自領先的國際學術中心的公認的關鍵思想領袖。我們很高興地註意到,每項試驗的結果都清楚地強調了 Focal One HIFU 治療的安全性、有效性以及額外的症狀和生活質量益處。
The Endo-HIFU-R1 Phase 2 study evaluated the safety of therapeutic HIFU for the treatment of rectal endometriosis, which results reported in January. Of 60 patients evaluated, 96.7% demonstrated positive safety with no or non-significant Clavien 1 adverse events. Only 3.3% presented Clavien 2 complications and zero patients presented Clavien 3 complications.
Endo-HIFU-R1 2 期研究評估了治療性 HIFU 治療直腸子宮內膜異位症的安全性,結果於 1 月報告。在接受評估的 60 名患者中,96.7% 的患者表現出積極的安全性,沒有或沒有顯著的 Clavien 1 不良事件。只有 3.3% 的患者出現 Clavien 2 並發症,零患者出現 Clavien 3 並發症。
A broad range of debilitating symptoms associated with endometriosis improved for the Focal One group as did almost all evaluated quality-of-life-based criteria at one, three, and six months. MRIs were performed in six months also demonstrated a significant reduction of lesion volume.
Focal One 組與子宮內膜異位症相關的廣泛衰弱症狀得到改善,幾乎所有評估的基於生活質量的標准在 1、3 和 6 個月時都有改善。六個月後進行的核磁共振成像也顯示病灶體積顯著減少。
To confirm the positive results from the Phase 2 study, we plan to initiate a Phase 3 study in the second quarter of this year. As a Level 1 study, we anticipate this being a multicenter, double-blind, randomized, controlled clinical trial enrolling approximately 60 subjects across eight centers in France, with 30 subjects randomized to each group.
為確認 2 期研究的積極結果,我們計劃在今年第二季度啟動 3 期研究。作為一項 1 級研究,我們預計這是一項多中心、雙盲、隨機、對照臨床試驗,在法國的八個中心招募了大約 60 名受試者,每組隨機分配 30 名受試者。
The primary efficacy endpoint will be acute pelvic pain three months post procedure. If results from this Phase 3 study are similar to the Phase 2 results, EDAP would have the strongest clinical evidence to date, demonstrating the utility of therapeutic HIFU to address this painful and debilitating condition.
主要療效終點將是術後三個月的急性盆腔疼痛。如果此 3 期研究的結果與 2 期結果相似,則 EDAP 將擁有迄今為止最有力的臨床證據,證明治療性 HIFU 可以解決這種痛苦和虛弱的狀況。
Based on the results thus far from this program, we believe Focal One HIFU could become an important new treatment option that would allow women suffering from deep infiltrating endometriosis to avoid the significant comorbidities associated with highly invasive surgical resection of the bowel or rectum.
根據該項目迄今為止的結果,我們認為 Focal One HIFU 可能成為一種重要的新治療選擇,可以讓患有深層浸潤性子宮內膜異位症的女性避免與高侵入性手術切除腸道或直腸相關的嚴重合併症。
Now let me turn to some very exciting clinical data that we recently announced at the 38th Annual Congress of the European Association of Urology. Results from the largest, multicenter, non-inferiority study ever conducted to prospectively evaluate HIFU against radical prostatectomy as a first-line treatment for patients with localized prostate cancer demonstrated a salvage treatment-free survival rate at 30 months of 90.1% in the HIFU-treated arm as compared to 86.8% in patients who underwent radical prostatectomy. Investigators found that the risk of salvage treatment was greater than 1.2-fold higher after radical prostatectomy than with Focal One.
現在讓我談談我們最近在歐洲泌尿外科協會第 38 屆年會上宣布的一些非常令人興奮的臨床數據。為前瞻性評估 HIFU 與根治性前列腺切除術作為局限性前列腺癌患者一線治療的最大、多中心、非劣效性研究的結果表明,HIFU 的 30 個月無挽救治療生存率為 90.1%。接受根治性前列腺切除術的患者接受治療的手臂與 86.8% 相比。研究人員發現,根治性前列腺切除術後進行挽救性治療的風險比 Focal One 高 1.2 倍以上。
Furthermore, ICS scores as a measure of urinary incontinence were significantly lower after Focal One HIFU and IIEF scores as a measure of erectile function decreased significantly less after HIFU than after radical prostatectomy. This is even more remarkable considering the Focal One treated patient group was on average 9.6 years older than the radical prostatectomy patients. Together, these two studies provide further clinical evidence supporting the efficacy of Focal One HIFU, enabling patients to maintain a higher level of baseline functionality while demonstrating good oncologic outcomes.
此外,作為衡量尿失禁的 ICS 評分在 Focal One HIFU 後顯著降低,而作為勃起功能衡量指標的 IIEF 評分在 HIFU 後比在根治性前列腺切除術後顯著降低。考慮到接受 Focal One 治療的患者組平均比接受根治性前列腺切除術的患者大 9.6 歲,這一點就更加引人注目了。這兩項研究共同提供了進一步的臨床證據,支持 Focal One HIFU 的療效,使患者能夠保持更高水平的基線功能,同時展示良好的腫瘤學結果。
Following our strong showing at the EAU meeting, our momentum continued into this year's American Urological Association meeting held just a couple of weeks ago in Chicago, where feedback and enthusiasm for Focal therapy from attending urologists and other thought leaders was universally very positive. AUA is widely recognized as the largest meeting of academic and practicing urologists globally, also attracting a large number of investors and research analysts with a defined focus in showcasing the latest advances in urologic medicine.
繼我們在 EAU 會議上的強勁表現之後,我們的勢頭一直持續到幾週前在芝加哥舉行的今年美國泌尿外科協會會議上,與會泌尿科醫生和其他思想領袖對 Focal 治療的反饋和熱情普遍非常積極。 AUA 被廣泛認為是全球最大的學術和實踐泌尿科醫生會議,也吸引了大量投資者和研究分析師,他們明確關注展示泌尿外科醫學的最新進展。
This year, EDAP had its largest AUA presence ever. Several plenary presentations and instructional courses were delivered by leading academic urologists, showcasing Focal One's ability to meet accepted oncological standards for the management of prostate cancer while preserving sexual function and urinary control. A particular interest was the Focal One scientific abstract presented by the prestigious Martini-Klinik in Hamburg, Germany.
今年,EDAP 擁有有史以來最大的 AUA 存在。領先的學術泌尿科醫師提供了幾次全體會議報告和教學課程,展示了 Focal One 能夠滿足公認的前列腺癌治療腫瘤學標準,同時保持性功能和尿液控制。特別感興趣的是德國漢堡著名的 Martini-Klinik 提供的 Focal One 科學摘要。
The Martini-Klinik has the largest prostate cancer treatment program in the world. The AUA abstract presented by the Martini-Klinik highlighted seven years' experience utilizing Focal One high-intensity focused ultrasound in 164 patients with prostate cancer. All treatments were established as primary therapy and monitoring definitions followed a very strict protocol. The oncologic outcomes showed excellent cancer control with only 7% significant infield recurrence and 91.5% radical treatment-free survival at seven years.
Martini-Klinik 擁有世界上最大的前列腺癌治療項目。 Martini-Klinik 提交的 AUA 摘要強調了在 164 名前列腺癌患者中使用 Focal One 高強度聚焦超聲七年的經驗。所有治療都被確定為主要治療,監測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,只有 7% 的顯著內野復發和 91.5% 的七年無根治治療生存率。
On the functional side, very few complications were reported with 91.5% of the 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。隨著我們繼續就 Focal One 機器人 HIFU 的好處進一步教育臨床醫生、患者和提供者,這些結果令人印象深刻。
Additionally, throughout the AUA meeting, EDAP was very busy giving numerous customers the 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,在整個 AUA 會議期間,EDAP 非常忙於為眾多客戶提供在模擬前列腺消融手術中使用 Focal One 的動手能力。他們能夠看到機器人定位系統、高級成像和融合功能的運行情況,同時制定了規定的消融治療計劃。
To further drive Focal One awareness and recognition, in April, we held a live global procedure broadcast featuring a Focal One HIFU treatment performed by Dr. Andre Abreu and Dr. Amir Lebastchi, both who are Assistant Professors of Clinical Urology at Keck Medicine of the University of Southern California. USC also happens to be the first US hospital institution to acquire and adopt EDAP's Robotic HIFU technology. This patient procedure broadcast enabled us to demonstrate the many important features and benefits of our Robotic HIFU technology platform to physicians, clinicians, and investors from around the world.
為了進一步提高 Focal One 的知名度和認可度,我們在 4 月舉行了一場全球程序直播,其中包括 Andre Abreu 博士和 Amir Lebastchi 博士進行的 Focal One HIFU 治療,他們都是凱克醫學臨床泌尿外科的助理教授南加州大學。南加州大學也恰好是美國第一家獲得併採用 EDAP 機器人 HIFU 技術的醫院機構。此次患者手術廣播使我們能夠向來自世界各地的醫生、臨床醫生和投資者展示我們的機器人 HIFU 技術平台的許多重要特性和優勢。
I'd now like to briefly discuss our exciting ExactVu 29 megahertz micro-ultrasound system developed for targeted biopsies in prostate cancer. ExactVu's proprietary technology allows urologists unparalleled visualization of prostate ultrasound images, thus leading to the real-time detection of suspicious areas necessary for performing precise prostate biopsies.
我現在想簡要討論一下我們為前列腺癌靶向活檢而開發的激動人心的 ExactVu 29 兆赫茲微超聲系統。 ExactVu 的專有技術使泌尿科醫生能夠對前列腺超聲圖像進行無與倫比的可視化,從而實時檢測執行精確前列腺活檢所需的可疑區域。
In the first quarter of 2023, we sold eight ExactVu units. Operating at 29 megahertz, the platform can generate micro-ultrasound resolution that is comparable to MRI, with a 300% improvement over conventional ultrasound technology.
2023 年第一季度,我們售出了 8 台 ExactVu。該平台以 29 兆赫茲的頻率運行,可以產生與 MRI 相當的微超聲分辨率,比傳統超聲技術提高 300%。
In April, we announced that ExactVu received commercial approval from Japan's Pharmaceutical and Medical Devices Agency. The Japanese market is the second largest global market for advanced medical device technology with prostate cancer as the most common cancer diagnosis in Japanese men, with over 100,000 new prostate cancer cases diagnosed annually.
4 月,我們宣布 ExactVu 獲得日本製藥和醫療器械機構的商業批准。日本市場是全球第二大先進醫療器械技術市場,前列腺癌是日本男性最常見的癌症診斷,每年診斷出超過 100,000 例新前列腺癌病例。
We have an existing strong presence of urology devices in Japan. And now with adding the revolutionary micro-ultrasound technology, we have the ability to significantly expand our business in the country.
我們在日本擁有強大的泌尿外科設備。現在,隨著革命性的微超聲技術的加入,我們有能力顯著擴大我們在該國的業務。
Before I turn the call over to Ken to review our financial performance in the last quarter, I just want to again acknowledge our strong cash position, which is a critical factor given the broader weakness in the capital markets. We ended the first quarter with EUR58.3 million or USD63.4 million.
在我將電話轉交給 Ken 審查我們上個季度的財務業績之前,我只想再次承認我們強大的現金狀況,鑑於資本市場普遍疲軟,這是一個關鍵因素。我們以 5830 萬歐元或 6340 萬美元結束了第一季度。
Maintaining a strong balance sheet enables us to make the necessary investments to fully maximize the opportunity for Focal One, ExactVu, and our broader portfolio of innovative technologies. As our sales pipeline continues to expand, it is becoming increasingly evident that the investments in our key technology platforms and commercial activities are helping drive demand in the market for our product offerings.
保持強勁的資產負債表使我們能夠進行必要的投資,以充分利用 Focal One、ExactVu 和我們更廣泛的創新技術組合的機會。隨著我們的銷售渠道不斷擴大,越來越明顯的是,對我們關鍵技術平台和商業活動的投資正在幫助推動市場對我們產品的需求。
With that, I will now turn it over to our US CFO, Ken, to discuss the financials. Ken?
有了這個,我現在將把它交給我們的美國首席財務官 Ken 來討論財務問題。肯?
Ken Mobeck - CFO, US Subsidiary
Ken Mobeck - CFO, US Subsidiary
Thank you, Ryan, and good morning, everyone. I would like to start by thanking our global cross-functional teams who executed with dedication to deliver a solid first quarter of 2023. Please note that all figures, except for percentages, are in euros. For conversion purposes, our average euro-dollar exchange rate was 1.0777 for the first quarter of 2023.
謝謝你,瑞安,大家早上好。首先,我要感謝我們的全球跨職能團隊,他們竭誠執行,在 2023 年第一季度取得了穩健的業績。請注意,除百分比外,所有數字均以歐元為單位。出於換算目的,我們 2023 年第一季度的平均歐元兌美元匯率為 1.0777。
Total revenue for the first quarter was EUR14.8 million, an increase of 13.8% as compared to EUR13 million for the same period in 2022, and a record level for a first quarter.
第一季度總收入為 1480 萬歐元,比 2022 年同期的 1300 萬歐元增長 13.8%,創下第一季度的歷史新高。
Looking at revenue by division, total revenue in the HIFU business for the first quarter was EUR5.3 million as compared to EUR3.8 million for Q1 2022. The 37.5% (sic - see press release, "39.5%") increase was driven primarily by six Focal One units sold in the first quarter versus four units sold in the first quarter of 2022.
按部門劃分的收入來看,第一季度 HIFU 業務的總收入為 530 萬歐元,而 2022 年第一季度為 380 萬歐元。增長 37.5%(原文如此 - 參見新聞稿,“39.5%”)是由於主要是第一季度售出 6 台 Focal One,而 2022 年第一季度售出 4 台。
Total revenue in the LITHO business for the first quarter was EUR2.8 million as compared to EUR2.2 million for the first quarter of 2022. The improvement was driven by four lithotripsy units sold in the first quarter as compared to one unit sold in the first quarter of 2022.
第一季度 LITHO 業務的總收入為 280 萬歐元,而 2022 年第一季度為 220 萬歐元。這一增長的推動因素是第一季度售出 4 台碎石機,而去年同期售出 1 台2022 年第一季度。
Total revenue in the distribution business for the first quarter was EUR6.8 million as compared to EUR7 million for the first quarter of 2022. The slight decrease was driven primarily by eight ExactVu units sold during the first quarter as compared to nine units sold during the first quarter of 2022.
第一季度分銷業務的總收入為 680 萬歐元,而 2022 年第一季度為 700 萬歐元。略有下降的主要原因是第一季度售出 8 台 ExactVu,而去年同期售出 9 台2022 年第一季度。
Gross profit for the first quarter was EUR6 million as compared to EUR5.8 million for the year-ago period. Gross profit margin on net sales was 40.8% in the first quarter compared to 44.3% in the year-ago period. The decrease in gross margin year over year was primarily due to investments in our service and clinical application support organizations in the US.
第一季度的毛利潤為 600 萬歐元,而去年同期為 580 萬歐元。第一季度淨銷售額的毛利率為 40.8%,而去年同期為 44.3%。毛利率同比下降主要是由於對我們在美國的服務和臨床應用支持組織的投資。
Operating expenses were EUR12.6 million for the first quarter compared to EUR5.9 million for the same period in 2022. The significant increase in operating expenses was mainly attributed to the planned build out and expansion of the US commercial team as well as non-recurring expenses that were linked to the CEO transition and succession plan we announced at the end of March.
第一季度的運營費用為 1260 萬歐元,而 2022 年同期為 590 萬歐元。運營費用的顯著增加主要歸因於美國商業團隊的計劃擴建和非與我們在 3 月底宣布的 CEO 交接和繼任計劃相關的經常性費用。
Operating loss for the first quarter was EUR6.6 million compared to an operating loss of EUR0.1 million in the first quarter of 2022. Excluding the impact of non-cash share-based compensation, operating loss for the first quarter would have been EUR3.9 million compared to an operating profit of EUR0.5 million in Q1 2022.
第一季度的運營虧損為 660 萬歐元,而 2022 年第一季度的運營虧損為 10 萬歐元。排除非現金股權補償的影響,第一季度的運營虧損為 3 歐元90 萬歐元,而 2022 年第一季度的營業利潤為 50 萬歐元。
Net loss for the first quarter of 2023 was EUR7.5 million or EUR0.2 per diluted share as compared to net income of EUR0.4 million or EUR0.01 per diluted share in the same year-ago period.
2023 年第一季度淨虧損為 750 萬歐元或攤薄後每股 0.2 歐元,而去年同期為淨收入 40 萬歐元或攤薄後每股 0.01 歐元。
As Ryan mentioned earlier, total cash and cash equivalents amounted to EUR58.3 million or USD63.4 million at the end of Q1 as compared to EUR63.1 million or USD67.5 million at the end of 2022.
正如 Ryan 之前提到的,第一季度末現金和現金等價物總額為 5830 萬歐元或 6340 萬美元,而 2022 年底為 6310 萬歐元或 6750 萬美元。
Those are our financial highlights for the first quarter of 2023. And with that, I would like to turn the call back to Ryan. Ryan?
這些是我們 2023 年第一季度的財務亮點。因此,我想把電話轉回給瑞安。賴安?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Thank you, Ken. In summary, our strong first-quarter results demonstrate that our efforts and strategies are proving effective. The improved reimbursement landscape is having an impact, and we believe Focal One HIFU is fast becoming a necessity to offer prostate cancer patients in the management of their disease.
謝謝你,肯。總之,我們強勁的第一季度業績表明我們的努力和戰略被證明是有效的。改善的報銷環境正在產生影響,我們相信 Focal One HIFU 正迅速成為為前列腺癌患者提供疾病管理的必需品。
Based upon the results today and the positive feedback from urologists, particularly at this year's recent AUA meeting, we have every reason to anticipate continued strength throughout 2023. We want to again recognize and thank the entire EDAP team and the pioneering clinicians and their patients who seek the benefits and value in embracing Focal One HIFU as an appropriate treatment choice.
根據今天的結果和泌尿科醫師的積極反饋,特別是在今年最近的 AUA 會議上,我們有充分的理由預計整個 2023 年將繼續保持強勁勢頭。我們要再次認可並感謝整個 EDAP 團隊以及開拓性的臨床醫生和他們的患者尋求將 Focal One HIFU 作為合適的治療選擇的好處和價值。
I will now turn it back over to the operator for questions. Operator?
我現在將其轉回給操作員提問。操作員?
Operator
Operator
Thank you. The floor is now open for questions. (Operator Instructions)
謝謝。現在可以提問了。 (操作員說明)
Joseph Downing, Piper Sandler.
約瑟夫·唐寧,派珀·桑德勒。
Joseph Downing - Analyst
Joseph Downing - Analyst
Hi, guys. Good morning. Joe here for Jason Bednar today. How is the Focal One utilization been trending in 1Q following the reimbursement upcoding? And what's the right way for investors to be thinking about utilization levels over the balance of the year, particularly as procedure volumes recover across the healthcare landscape?
嗨,大家好。早上好。喬今天為傑森·貝德納而來。報銷升級後,第一季度 Focal One 的使用趨勢如何?投資者考慮今年餘下時間的利用率水平的正確方法是什麼,特別是隨著整個醫療保健領域的手術量恢復?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yes. So we've stated before, on a trend basis, Q1 is certainly favorable. We continue to see double-digit growth, but we don't share our exact numbers. So directionally, we're seeing the benefits of the reimbursement change that went into effect January.
是的。所以我們之前說過,從趨勢來看,第一季度肯定是有利的。我們繼續看到兩位數的增長,但我們不分享我們的確切數字。因此,在方向上,我們看到了 1 月份生效的報銷變更帶來的好處。
We're again monitoring this very closely. And remember also, we also added last year our regional clinical manager team and applications team, so they're part of the process of driving hospital-based utilization. So again, we're trending favorably, and we are excited about the momentum in the market. And we continue to monitor it on a daily, weekly, monthly, and quarterly basis.
我們再次密切關注此事。還要記住,我們去年還增加了我們的區域臨床經理團隊和應用團隊,因此他們是推動基於醫院的利用過程的一部分。因此,我們的趨勢再次向好,我們對市場的發展勢頭感到興奮。我們繼續每天、每週、每月和每季度對其進行監控。
Joseph Downing - Analyst
Joseph Downing - Analyst
Great. Thanks, Ryan. And then I think you mentioned on the previous call that there wasn't much in the way of a broad hesitation to purchase capital equipment. Just wondering if there's any update on how the capital equipment environment is shaping up amongst your hospital customers? And is there any distinction being made between buying patterns than, say, some the larger versus some of the smaller hospital customers you serve?
偉大的。謝謝,瑞安。然後我想你在之前的電話會議上提到,購買資本設備並沒有太大的猶豫。只是想知道是否有任何關於資本設備環境在您的醫院客戶中如何形成的最新消息?購買模式之間是否有任何區別,比如,你服務的一些較大的醫院客戶與一些較小的醫院客戶?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yes, I think from my vantage point and how we look at it, it seems to be pretty consistent. Depending on markets, there are some pressures, I think, in some institutions. But I think where we have been effective is obviously we've talked about reimbursement and that change. But adding Focal therapy to your prostate cancer treatment options for an institution is really strategic in nature. It's not an operational investment.
是的,我認為從我的角度和我們的看法來看,它似乎非常一致。根據市場的不同,我認為某些機構存在一些壓力。但我認為我們一直有效的地方顯然是我們討論了報銷和這種變化。但是,在機構的前列腺癌治療方案中加入局部治療在本質上確實具有戰略意義。這不是一項運營投資。
So centers that understand that, this is anchored in cancer, it's anchored in the number-one cancer diagnosed in men, it's also tied to men's health initiatives typically found in hospital institutions. So we continue to work through the processes, as noted.
所以中心明白,這與癌症有關,與男性診斷出的頭號癌症有關,也與通常在醫院機構中發現的男性健康倡議有關。因此,如前所述,我們將繼續完成這些流程。
We do see more interest coming from community hospitals. We work both academic centers and community hospitals in tandem. And I think some of the benefits of reimbursement have played into making the decision to invest in acquiring Focal One Robotic HIFU technology. So we're excited to see the engagement. And as mentioned, we've hired more sales people. So I think we're getting more touches out in the market.
我們確實看到更多的興趣來自社區醫院。我們協同工作學術中心和社區醫院。而且我認為報銷的一些好處已經影響了投資收購 Focal One 機器人 HIFU 技術的決定。所以我們很高興看到訂婚。如前所述,我們僱傭了更多的銷售人員。所以我認為我們正在市場上進行更多的接觸。
Joseph Downing - Analyst
Joseph Downing - Analyst
Perfect. Thanks, Ryan. And one more, I appreciate the updates on Phase 3. It seems like no change there for rectal endometriosis. I'm wondering if you could update us on where some of the clinical work sits and some of the other indications you're pursuing, particularly for BPH. What are some reasonable timelines or milestones you're extracting there? And are there any other indication expansion we should have on our radar?
完美的。謝謝,瑞安。還有一點,我很欣賞第 3 階段的更新。直腸子宮內膜異位症似乎沒有變化。我想知道您是否可以向我們介紹一些臨床工作的進展情況以及您正在尋求的其他一些適應症,尤其是 BPH。您在那裡提取的一些合理的時間表或里程碑是什麼?還有我們應該關注的任何其他跡象擴展嗎?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yes. So we've socialized the activity on BPH really being more focused on feasibility study work we're doing in Europe. We're going to broaden that in some regards. We have a plan to do that. But a lot of that work is being done currently in Europe. And we'll look for a strategy more specific to the US over time.
是的。因此,我們已經將 BPH 活動社會化,真正更加關注我們在歐洲所做的可行性研究工作。我們將在某些方面擴大這一範圍。我們有計劃這樣做。但目前歐洲正在開展大量此類工作。隨著時間的推移,我們將尋找更適合美國的戰略。
Again, we have a lot of strong users in Europe, as you can imagine, and many are participating in some of the early feasibility work that we're doing. And as we move forward, we'll look to expand that at some point with US sites.
同樣,正如您可以想像的那樣,我們在歐洲有很多強大的用戶,並且許多人正在參與我們正在進行的一些早期可行性工作。隨著我們的前進,我們將尋求在某個時候通過美國站點擴展它。
But again, we're still early in our feasibility work and we're continuing to make progress as planned. Nothing else that I can speak to about other indications other than what's been already mentioned with endometriosis.
但同樣,我們的可行性工作仍處於早期階段,我們將繼續按計劃取得進展。除了已經提到的子宮內膜異位症之外,我無話可說。
Joseph Downing - Analyst
Joseph Downing - Analyst
Great. Really appreciate the updates.
偉大的。非常感謝更新。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Thank you, Joe.
謝謝你,喬。
Operator
Operator
Mike Sarcone, Jefferies.
邁克·薩爾科內,傑富瑞。
Mike Sarcone - Analyst
Mike Sarcone - Analyst
Hi, thanks. And thanks for taking my questions. So just to start, can you elaborate a little bit more, Ryan, on the sales funnel? And maybe just give us an update on how conversations went at AUA and maybe the new leads that you generated post that conference.
你好謝謝。感謝您回答我的問題。因此,剛開始時,Ryan,你能詳細說明一下銷售漏斗嗎?也許只是向我們提供有關 AUA 對話進展情況的最新信息,以及您在該會議後產生的新線索。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yeah, Michael. We had a real strong showing, as mentioned, at AUA, stronger showing ever. We were large; we were prominent. And we even added some presentations in our booth throughout the meeting. So we brought our whole capital team there. So we had everybody on board.
是的,邁克爾。如前所述,我們在 AUA 的表現非常出色,比以往任何時候都更出色。我們很大;我們很突出。我們甚至在整個會議期間在我們的展位上添加了一些演示文稿。所以我們把整個資本團隊都帶到了那裡。所以我們讓每個人都參與其中。
The engagement, I would say, was very high. For some customers, they were already in our pipeline and we're moving them through that sales pipeline. But we also had notable new touches from new hospitals. And so I think as we've continued to make progress in growing our install base, there's -- realize that Focal therapy is a necessity and hospitals need to answer to that.
我想說,參與度非常高。對於一些客戶,他們已經在我們的管道中,我們正在通過該銷售管道移動他們。但我們也從新醫院那裡獲得了顯著的新變化。因此,我認為,隨著我們在擴大安裝基礎方面繼續取得進展,意識到焦點治療是必要的,醫院需要對此做出回應。
And when they answer to that, the question is: what technology do they answer with? And that's where I think we've been strong in our showing and being able to -- there at that meeting actually give hands-on procedural simulations of a Focal One treatment. We did that throughout the meeting. We also used and showed our 29 megahertz micro-ultrasound product, ExactVu. So we had more than one product to talk about.
當他們回答這個問題時,問題是:他們用什麼技術回答?這就是我認為我們在展示和能力方面一直很強大的地方——在那次會議上,我們實際上對 Focal One 治療進行了實際操作的程序模擬。我們在整個會議期間都這樣做了。我們還使用並展示了我們的 29 兆赫微型超聲產品 ExactVu。所以我們要談論的產品不止一種。
But I would say, overall, the engagement was very high. There were some notable presentations given. And again, as we've added recent headcount to our sales team, we had everybody there who was available to really take advantage of AUA and our strong showing. So I think our pipeline continues to build. It's the strongest it's ever been, and we continue to add new accounts into that active pipeline.
但我要說的是,總體而言,參與度非常高。有一些值得注意的介紹。再一次,隨著我們為銷售團隊增加了最近的員工人數,我們那裡的每個人都可以真正利用 AUA 和我們的強勁表現。所以我認為我們的管道會繼續建設。這是有史以來最強大的,我們將繼續向該活動管道中添加新帳戶。
Mike Sarcone - Analyst
Mike Sarcone - Analyst
Okay, thanks. That's really helpful. And I would love to also hear just what kind of turnout you got for the live procedure in April, and maybe the conversations and then the level of awareness you're seeing post that live procedure.
好的謝謝。這真的很有幫助。我也很想听聽您在 4 月份的現場程序中獲得了什麼樣的投票率,也許還有對話以及您在現場程序後看到的意識水平。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yes. So we had a couple 100 folks logged on for the live event. And again, we still see people going back to watch the replay. So I think it exceeded our expectations. We also had representatives from all over the world. So it wasn't just from the US. So we had promoted that on a global basis and saw many physicians from the extended OUS markets also watching the live broadcast.
是的。因此,我們有 100 人登錄了現場活動。再一次,我們仍然看到人們回去觀看重播。所以我認為它超出了我們的預期。我們還有來自世界各地的代表。所以它不僅僅是來自美國。因此,我們在全球範圍內進行了推廣,並看到許多來自 OUS 擴展市場的醫生也在觀看直播。
And again, it was very well received. I think people really had a better understanding of how our technology works, how it's very efficient. They got to see all the benefits that we typically describe, the robotic positioning system, the contouring capability in Focal One, the speed of treatment which is notably something that we discuss with many of our customers because we have a very efficient way to ablate prostate tissue.
再一次,它很受歡迎。我認為人們真的更好地理解了我們的技術是如何工作的,它是如何非常有效的。他們看到了我們通常描述的所有好處,機器人定位系統,Focal One 的塑形能力,治療速度,這是我們與許多客戶討論的特別問題,因為我們有一種非常有效的前列腺消融方法組織。
So again, it was a very good showing for us, and we still see customers continue to log on to watch it for educational purposes, or just to better understand the technology.
同樣,這對我們來說是一個非常好的展示,我們仍然看到客戶繼續登錄觀看它用於教育目的,或者只是為了更好地了解技術。
Mike Sarcone - Analyst
Mike Sarcone - Analyst
Okay, great. And then just one more for me, maybe for Ken. How should we think about OpEx spend through the rest of the year?
好的,太好了。然後再給我一個,也許是給 Ken 的。我們應該如何考慮今年剩餘時間的運營支出?
Ken Mobeck - CFO, US Subsidiary
Ken Mobeck - CFO, US Subsidiary
Yes. So for OpEx this year, we should continue to see it grow a little bit quarter over quarter as we continue to invest in both the commercial infrastructure to help build out the business here in the United States.
是的。因此,對於今年的 OpEx,我們應該繼續看到它比上一季度略有增長,因為我們繼續投資商業基礎設施以幫助在美國建立業務。
Mike Sarcone - Analyst
Mike Sarcone - Analyst
Okay. Thanks a lot.
好的。多謝。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Thanks, Michael.
謝謝,邁克爾。
Operator
Operator
Sean Lee, H.C. Wainwright.
肖恩·李,H.C.溫賴特。
Sean Lee - Analyst
Sean Lee - Analyst
Good morning, Ryan and Ken. Thanks for taking my questions. My first one is on the upcoming Phase 3 study. Could you provide a bit more color on the design of the study? And also, whether there are any changes in terms of patient selection and treatment compared to the previous Phase 1, 2?
早上好,瑞安和肯。感謝您回答我的問題。我的第一個是關於即將進行的第三階段研究。您能否為研究設計提供更多色彩?還有,與之前的一期、二期相比,在患者選擇和治療方面有什麼變化嗎?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yes, so you're referring to the endometriosis study. Is that correct?
是的,所以你指的是子宮內膜異位症研究。那是對的嗎?
Sean Lee - Analyst
Sean Lee - Analyst
That's correct, yes.
沒錯,是的。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yeah. So the Phase 3 study, as mentioned, it will be 60 patients. This is a blinded study, so half of those patients will be subject to an ablation of their endometrial implants and the other half will be part of a sham, non-treatment arm.
是的。因此,如前所述,第三階段研究將有 60 名患者。這是一項盲法研究,因此這些患者中的一半將接受子宮內膜植入物的消融,另一半將成為假的、非治療組的一部分。
So again, I think this being a more stricter study in terms of protocol and design will really allow us to show with increasing evidence the value of being able to ablate endometrial implants of the rectum for women suffering from deep rectal endometriosis.
因此,我再次認為,這是一項在方案和設計方面更嚴格的研究,這將真正讓我們以越來越多的證據展示能夠為患有深部直腸子宮內膜異位症的女性消融直腸子宮內膜植入物的價值。
So again, we're working closely with the center and enrolling patients as we're speaking now because we're in Q2. And again, we're excited about the momentum and the interest. And we'll continue to work closely with our lead site as we enroll more patients and treat more patients.
因此,我們正在與中心密切合作,並在我們現在發言時招募患者,因為我們處於第二季度。再一次,我們對勢頭和興趣感到興奮。隨著我們招募更多患者並治療更多患者,我們將繼續與我們的領先站點密切合作。
Sean Lee - Analyst
Sean Lee - Analyst
Great. Just a quick follow-up. Considering that the pilot sites are all in France, do you believe that the results of this study could be used to support approval in this indication to US as well?
偉大的。只是快速跟進。考慮到試點地點都在法國,您是否認為這項研究的結果也可以用來支持美國批准該適應症?
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yeah. Sean, that's a great question. Yes, we would want to use that data. One of our goals we've socialized is getting in front of the FDA this year for a pre-submission and really get a further understanding of what the acceptable data that we'll be looking for.
是的。肖恩,這是一個很好的問題。是的,我們想要使用這些數據。我們已經社交化的目標之一是今年在 FDA 面前進行預提交,並真正進一步了解我們將尋找的可接受數據。
But I think that data would be very useful from all the studies we've done, certainly the more recent one we're working on, but also the Phase 2 study that we had already completed. So we'll have to see what the FDA's response will be. But our goal, yes, would be to use that data where needed to make a case for a new indication in the US.
但我認為,我們所做的所有研究的數據都會非常有用,當然是我們正在進行的最近的一項研究,還有我們已經完成的第二階段研究。所以我們必須看看 FDA 的反應是什麼。但我們的目標,是的,將是在需要的地方使用這些數據來為美國的新適應症提供理由。
Sean Lee - Analyst
Sean Lee - Analyst
Great. Thanks for the time. That's all I have.
偉大的。謝謝你的時間。這就是我的全部。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Thank you, Sean.
謝謝你,肖恩。
Operator
Operator
Frank Takkinen, Lake Street Capital Markets.
弗蘭克·塔基寧 (Frank Takkinen),湖街資本市場。
Frank Takkinen - Analyst
Frank Takkinen - Analyst
Hey. Thanks for taking the questions. I was hoping we could revisit placement expectations for the year. Clearly, a strong start with seven this year. Looking back at last year, it's obviously a much more volatile macro environment, so a little bit hard to take away any meaningful insight from the placement sequential cadence from last year.
嘿。感謝您提出問題。我希望我們可以重新審視今年的安置預期。顯然,今年有七個開局。回顧去年,這顯然是一個更加動蕩的宏觀環境,因此很難從去年的安置順序節奏中剔除任何有意義的見解。
But maybe could you just speak to -- generally speaking, if we should be getting back to a more normalized seasonal pattern of Q1 is normally the lightest and Q2 and Q3 a little bit better. Maybe some lightness in Q3 due to OUS seasonality and then Q4 being strongest. But I'm just hoping you can kind of put some guideposts around placement expectations for 2023.
但也許你能談談——一般來說,如果我們應該回到更正常化的季節性模式,Q1 通常是最輕的,而 Q2 和 Q3 稍微好一點。由於 OUS 的季節性,第三季度可能有些輕盈,然後第四季度最強。但我只是希望你能為 2023 年的安置預期設置一些指南。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yes. So, Frank, I would look at it as kind of similar to what you had referenced. Certainly, coming off of Q1, we're continuing to see some momentum in the market. But again, hospitals buy on their own timelines. So it's sometimes hard to predict, again, if a deal gets done in a particular quarter or moves out a quarter.
是的。所以,弗蘭克,我認為它與你提到的有點相似。當然,從第一季度開始,我們將繼續看到市場的一些勢頭。但同樣,醫院按照自己的時間表購買。因此,有時很難再次預測交易是在特定季度完成還是在一個季度結束。
I would say on a directional basis, I think we would expect to see anticipated growth similar to what you referenced, Q2 being a quarter that would be certainly positive over prior year. I can't give you exact numbers.
我想說的是,在方向性的基礎上,我認為我們預計會看到與您所提到的類似的預期增長,第二季度肯定會比去年同期增長。我不能給你確切的數字。
But also as mentioned, if we walk into Q3 and you see sometimes a slowdown, especially in OUS markets and even sometimes in the US, and then you come out of it in Q4, which is typically seasonally our strongest quarter or strongest quarter for capital purchases. So I think we would follow along those lines in terms of how we would predict capital sales for the remainder of the year.
但也如前所述,如果我們進入第三季度,您有時會看到經濟放緩,尤其是在美國市場,甚至有時在美國,然後您會在第四季度擺脫它,這通常是我們季節性最強的季度或資本最強勁的季度購買。因此,我認為我們將遵循這些思路來預測今年剩餘時間的資本銷售。
As mentioned, too, and just answering a question, we did add -- we've added some new capital sales executives. And our total sales team today is at about 19, both capital and clinical. We expect that number to jump by in a year to 38 to 40. So with that said, as we onboard more of those folks and have more touches and engagement, we would anticipate continuing to build a strong pipeline of potential accounts.
正如所提到的,只是回答一個問題,我們確實增加了——我們增加了一些新的資本銷售主管。我們今天的總銷售團隊大約有 19 人,包括資本和臨床。我們預計這一數字將在一年內躍升至 38 至 40 人。話雖如此,隨著我們招募更多這樣的人並進行更多接觸和參與,我們預計將繼續建立強大的潛在客戶渠道。
Frank Takkinen - Analyst
Frank Takkinen - Analyst
Okay, that's helpful. And then my second question was actually going to be directly on the sales organization. So thanks for that color. Maybe if you could provide a little more color, expected hiring cadence throughout the year to get to 38 to 40. Should we think of that as a linear progression throughout the year? And maybe just talk about the quality of sales reps you're attracting to the organization now.
好的,這很有幫助。然後我的第二個問題實際上將直接針對銷售組織。所以謝謝你的顏色。也許如果你能提供更多顏色,預計全年的招聘節奏將達到 38 到 40。我們是否應該將其視為全年的線性增長?也許只是談談你現在吸引到組織的銷售代表的素質。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Yeah, Frank. So I'd say the quality -- we're tapping into a higher-quality segment of potential sales executives. And I think a lot of it is relevant to this story and we'll call it wins that we've had in the market already. And I think people understand what we're doing: right product, right time, right market. So I think quality, obviously, is always important. But I'm impressed with the recent hires we've made on the capital side and clinical side.
是的,弗蘭克。所以我想說的是質量——我們正在挖掘潛在銷售主管的更高質量部分。我認為其中很多與這個故事有關,我們稱之為我們已經在市場上取得的勝利。我認為人們理解我們在做什麼:正確的產品、正確的時間、正確的市場。所以我認為質量,顯然,總是很重要的。但我對我們最近在資本方面和臨床方面所做的招聘印象深刻。
But speaking to the cadence, the capital team will typically ramp faster, because we're out selling capital. The clinical team will be hired as a result of those capital placements. So depending on the market, we would hire additional clinical folks. We would hire them as to where we place those systems.
但就節奏而言,資本團隊通常會加快速度,因為我們正在出售資本。這些資本配售將聘用臨床團隊。因此,根據市場情況,我們會僱用更多的臨床人員。我們會僱用他們來確定我們放置這些系統的位置。
So they typically trail the system placements on some level, obviously, a coverage model, your largest MSAs, or metropolitan statistical areas. We focus on those and/or large metropolitan markets where there's a higher concentration of patients and hospitals.
因此,它們通常在某種程度上落後於系統佈局,顯然是覆蓋模型、最大的 MSA 或大都市統計區域。我們專注於患者和醫院高度集中的那些和/或大都市市場。
So I would just say, we continue to interview and hire routinely. And we'll do that in quarters two, the quarter we're in now, three and four, and hit our year-end goal of having a fully staffed team.
所以我只想說,我們繼續例行面試和招聘。我們將在第二季度、第三季度和第四季度做到這一點,並實現我們擁有一支人員齊全的團隊的年終目標。
But again, I think the capital folks will be hired before the clinical folks typically. And we'll make the necessary adjustments on an as needed basis. So we're excited to make those investments and we're on our roadmap. Currently, we're on plan and we'll continue to make those additional hires throughout the rest of the year.
但同樣,我認為資本人員通常會在臨床人員之前被雇用。我們將根據需要進行必要的調整。因此,我們很高興進行這些投資,並且我們正在製定路線圖。目前,我們正在計劃中,我們將在今年餘下的時間裡繼續招聘這些額外人員。
Frank Takkinen - Analyst
Frank Takkinen - Analyst
Got it. That's helpful. Maybe the last one for Ken. As it relates to the gross margin, how should we be thinking -- obviously the HIFU continuing to become a larger portion of sales. That should naturally bring up that margin profile over time. But maybe just if you could throw some goalposts around gross margins expectations for the year, that'd be helpful as well.
知道了。這很有幫助。也許是 Ken 的最後一個。由於它與毛利率有關,我們應該如何思考——顯然 HIFU 繼續成為銷售額的較大部分。隨著時間的推移,這自然會提高利潤率。但也許如果你能圍繞今年的毛利率預期設定一些目標,那也會有所幫助。
Ken Mobeck - CFO, US Subsidiary
Ken Mobeck - CFO, US Subsidiary
Yeah. So on the HIFU business, we should definitely -- as we sell more HIFU during the year, that will definitely be accretive to gross margin. So we will definitely see margin tick up there. In our other businesses, particular distribution, we need to trend the mix of products.
是的。因此,在 HIFU 業務上,我們絕對應該——因為我們在這一年銷售了更多的 HIFU,這肯定會增加毛利率。所以我們肯定會看到保證金在那裡上漲。在我們的其他業務中,特別是分銷,我們需要趨勢產品組合。
We did see distribution margin ticked down a little bit just due to mix of product, especially in Japan. And then I think also on the US front, as procedure volumes grow, okay, that will continue to also help aid to accretive gross margins in the Focal One space in the US.
我們確實看到分銷利潤率因產品組合而略有下降,尤其是在日本。然後我認為在美國方面,隨著手術量的增長,好吧,這也將繼續幫助提高美國 Focal One 領域的毛利率。
Frank Takkinen - Analyst
Frank Takkinen - Analyst
Okay. That's helpful. Thanks for taking the questions and congrats on all the progress.
好的。這很有幫助。感謝您提出問題並祝賀所有進展。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
Thank you, Frank.
謝謝你,弗蘭克。
Operator
Operator
Thank you. At this time, I would like to turn the floor back over to Mr. Rhodes for closing comments.
謝謝。現在,我想將發言權轉回 Rhodes 先生以徵求結束意見。
Ryan Rhodes - CEO
Ryan Rhodes - CEO
In closing, I want to thank all who participated in today's call. We look forward to speaking with you in August on results from our 2023 second-quarter earnings release. Thank you, again.
最後,我要感謝所有參加今天電話會議的人。我們期待在 8 月與您討論我們 2023 年第二季度財報發布的結果。再次感謝你。
Operator
Operator
Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your line or log off the webcast at this time, and enjoy the rest of your day.
女士們,先生們,感謝你們的參與。今天的活動到此結束。您可以在此時斷開您的線路或註銷網絡廣播,並享受您一天的剩餘時間。