NeuroOne Medical Technologies Corp (NMTC) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good day, ladies and gentlemen, and welcome to NeuroOne Medical Technologies Corporation's second-quarter fiscal 2026 financial results conference call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; and Ron McClurg, the company's Chief Financial Officer.

    各位女士、各位先生,大家好,歡迎參加 NeuroOne Medical Technologies Corporation 2026 會計年度第二季財務業績電話會議。今天的電話會議將由公司執行長 Dave Rosa 以及公司財務長 Ron McClurg 主持。

  • Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of US federal securities laws with respect to future operations, financial results, including events, trends and performance, which are based on management's beliefs and assumptions as of today's call.

    在我將電話交給 Rosa 先生之前,我想提醒各位,本次電話會議將包含依據美國聯邦證券法所定義的前瞻性陳述,內容涉及未來營運與財務結果,包括事件、趨勢與表現,並係基於管理層截至本次電話會議當日的信念與假設。

  • Forward-looking statements may involve known and unknown risks, uncertainties and other factors, which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, NeuroOne undertakes no obligation to update such forward-looking statements.

    前瞻性陳述可能涉及已知與未知的風險、不確定性及其他因素,可能導致實際結果與該等陳述所明示或暗示者存在重大差異。關於可能導致實際結果不同的特定風險與不確定性資訊,請參閱 NeuroOne 的財務業績新聞稿及向 SEC 提交的文件。除法律另有要求外,NeuroOne 不承擔更新該等前瞻性陳述之義務。

  • With that, I will turn the call over to Mr. Dave Rosa, Chief Executive Officer of NeuroOne. Please go ahead, sir.

    那麼,我現在將電話交給 NeuroOne 執行長 Dave Rosa 先生。先生,請開始。

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Thank you, operator, and thank you to everyone for joining us today. I'd like to welcome you to our second-quarter fiscal 2026 financial results conference call. Product revenue for the OneRF brain ablation system in the second quarter of fiscal 2026 grew 72% year over year to $2.4 million compared to $1.4 million in the second quarter of fiscal 2025.

    謝謝接線員,也感謝各位今天加入我們。我在此歡迎各位參加我們 2026 會計年度第二季財務業績電話會議。2026 會計年度第二季 OneRF 腦部消融系統的產品營收年增 72%,達到 240 萬美元,相較於 2025 會計年度第二季的 140 萬美元。

  • We continue to be energized by reports of the positive impact this therapy is having on people's lives. Most recently, the US Department of Veterans Affairs published an article regarding Dr. Garrett Banks experience with the technology. The article discussed the challenges that Navy veteran Derek Harpole had to endure after being diagnosed with epilepsy.

    我們持續因為這項療法對人們生活帶來的正面影響而備受鼓舞。最近,美國退伍軍人事務部(US Department of Veterans Affairs)發表了一篇文章,介紹 Garrett Banks 醫師使用該技術的經驗。文章討論了海軍退伍軍人 Derek Harpole 在被診斷為癲癇後必須承受的挑戰。

  • For more than two decades, he was unable to work, drive or hunt alone. Dr. Banks and his team at the Houston VA performed their first OneRF brain ablation procedure on Derek. He woke up the morning after the procedure bright-eyed and bushy-tailed in his words. With his seizures dramatically reduced, he now has hope that he can regain the life he once had.

    二十多年來,他無法工作、開車或獨自狩獵。Banks 醫師與其位於休士頓 VA 的團隊為 Derek 進行了他們的第一例 OneRF 腦部消融手術。用他自己的話說,他在手術後隔天早上醒來時精神奕奕、神采飛揚。由於癲癇發作大幅減少,他如今重新燃起希望,期待能找回曾經擁有的生活。

  • Through our partnership with Zimmer Biomet, our goal is to expand this therapy into new centers in order to change other people's lives as well. The company also had several important corporate developments I'd like to highlight. First, we appointed David Wambeke as Chief Business Officer to lead our drug delivery program, oversee Investor Relations and support business development. As a meaningful sign of his confidence, David purchased 1 million shares of NeuroOne common stock on a pre-split basis.

    透過與 Zimmer Biomet 的合作,我們的目標是將這項療法擴展至新的中心,進而改變更多人的生活。公司也有幾項重要的企業發展我想特別說明。首先,我們任命 David Wambeke 擔任首席商務長(Chief Business Officer),負責領導我們的藥物遞送計畫、監督投資人關係並支援業務發展。作為其信心的重要展現,David 以拆股前基準購買了 100 萬股 NeuroOne 普通股。

  • We were also pleased to announce that we regained compliance with Nasdaq's minimum bid price requirement following a 1-for-6 reverse split of our common stock. Finally, we are always excited to welcome new investors, and we're pleased to learn a new high net worth investor acquired approximately 7.4% of our outstanding common stock in the open market.

    我們也很高興宣布,在對普通股進行 1 比 6 反向拆股後,我們已重新符合 Nasdaq 的最低買入價(minimum bid price)要求。最後,我們也一向樂於迎接新投資人,並欣然得知一位新的高淨值投資人在公開市場收購了約占我們已發行普通股 7.4% 的股份。

  • Now let's move on to discuss the exciting progress we have made with our existing product portfolio. Regarding our OneRF brain ablation system, as I mentioned in the opening, we experienced 72% year-over-year revenue growth. We believe there is upside for growth domestically and internationally.

    接下來讓我們談談既有產品組合所取得的令人振奮的進展。就 OneRF 腦部消融系統而言,如我在開場提到的,我們的營收年增 72%。我們相信在美國國內與國際市場仍有成長上行空間。

  • Domestically, we are developing a webinar that will highlight clinical experience with the device that we can expand exposure to neurologists and neurosurgeons that may not be aware of the exciting results that are being reported.

    在美國國內方面,我們正在製作一場網路研討會(webinar),將重點呈現該裝置的臨床使用經驗,以擴大對可能尚未了解目前回報之令人振奮成果的神經科醫師與神經外科醫師的曝光。

  • With respect to international commercialization progress, we completed the Stage 2 audit of our Minnesota facility for ISO 13485 certification and remain bullish on certification in the latter part of 2026, which is a key step in the process of enabling international distribution of our products.

    在國際商業化進展方面,我們已完成明尼蘇達州廠區 ISO 13485 認證的第二階段稽核(Stage 2 audit),並仍然看好在 2026 年後期取得認證;這是推動我們產品得以進行國際分銷流程中的關鍵一步。

  • We also had an important clinical milestone this quarter with the publication of a peer-reviewed case series that validates what physicians using our platform have been telling us. That real-time temperature monitoring during SEEG-guided RF ablation is an important technology feature when performing brain ablations on patients with drug-resistant epilepsy.

    本季我們也達成一項重要的臨床里程碑:一篇經同儕審查的病例系列(case series)發表,驗證了使用我們平台的醫師一直告訴我們的內容——在 SEEG 導引的射頻(RF)消融過程中進行即時溫度監測,是為藥物難治型癲癇患者執行腦部消融時的一項重要技術特性。

  • The OneRF brain ablation system was also highlighted at Zimmer Biomet's booth at the American Association of Neurological Surgeons meeting in San Antonio, Texas, alongside presentations on the technology.

    OneRF 腦部消融系統也在德州聖安東尼奧舉行的美國神經外科醫師協會(American Association of Neurological Surgeons)年會上,於 Zimmer Biomet 的展位中亮相,並搭配多場關於該技術的簡報。

  • Moving on to our OneRF trigeminal nerve ablation system, we have continued to gain clinical experience and have experienced clinical success following our FDA 510(k) clearance and limited market release. To date, we have successfully completed 16 cases using the ablation system for the treatment of facial pain known as trigeminal neuralgia, with all patients reportedly pain-free after the procedure.

    接著談到我們的 OneRF 三叉神經消融系統,在取得 FDA 510(k) 核准並進行有限度市場上市(limited market release)後,我們持續累積臨床使用經驗並取得臨床成功。迄今為止,我們已成功完成 16 例使用該消融系統治療稱為三叉神經痛(trigeminal neuralgia)的臉部疼痛病例,據報所有患者在手術後皆無疼痛。

  • We continue to be optimistic regarding the advantages and clinical performance of the device for treating facial pain. As a reminder, unlike traditional ablation systems, our product is intended to be placed once due to the multiple contacts present on the device, whereas traditional systems typically require multiple probe placements that can cause additional patient discomfort and extend treatment times.

    我們對該裝置在治療臉部疼痛方面的優勢與臨床表現仍保持樂觀。提醒各位,與傳統消融系統不同,我們的產品因裝置上具有多個接觸點,設計上只需放置一次;而傳統系統通常需要多次探針放置,可能造成患者額外不適並延長治療時間。

  • We were also pleased to be highlighted in the Business Research Company's April 24, 2026, report which noted that emerging growth patterns are driving expansion in the trigeminal neuralgia market valued at approximately $780 million toward stereotactic surgery using technology similar to our OneRF trigeminal nerve ablation system.

    我們也很高興在 Business Research Company 於 2026 年 4 月 24 日發布的報告中被重點提及;該報告指出,新興成長型態正推動市值約 7.8 億美元的三叉神經痛市場,朝向使用與我們 OneRF 三叉神經消融系統類似技術的立體定位手術(stereotactic surgery)擴張。

  • Regarding our drug delivery program, we remain on track for commercial availability of the system in the second half of fiscal 2026 for use in investigational clinical studies or animal studies. Also, we are currently evaluating distributors for commercialization of the product.

    關於我們的藥物遞送計畫,我們仍按計畫在 2026 會計年度下半年使該系統具備商業可用性,以供研究性臨床研究或動物研究使用。此外,我們目前也正在評估用於產品商業化的經銷商。

  • In addition, we announced a collaboration with the Department of Neurology's Division of Epilepsy at the University of Minnesota Medical School to advance a study evaluating next-generation epilepsy therapies using our drug delivery platform.

    此外,我們宣布與明尼蘇達大學醫學院(University of Minnesota Medical School)神經科癲癇分部(Department of Neurology's Division of Epilepsy)合作,推進一項研究,使用我們的藥物遞送平台評估下一代癲癇療法。

  • Moving on to our two lower back pain management programs, I will first provide an update on our Basivertebral nerve ablation system. This quarter, we completed the user design requirements for the system and initiated preclinical testing to support continued development of the program.

    接下來談到我們兩項下背痛管理計畫,我將先更新我們的椎體終板神經(Basivertebral nerve)消融系統。本季我們完成了該系統的使用者設計需求(user design requirements),並啟動臨床前測試(preclinical testing),以支持該計畫的持續開發。

  • Our strategy remains to leverage our existing OneRF generator, temperature accessory, and ablation electrode while outsourcing access tools either through outside vendors or potential distribution partners. We continue to remain excited about the prospects of the system given the potential clinical advantages it offers.

    我們的策略仍是利用既有的 OneRF 產生器、溫度配件與消融電極,同時透過外部供應商或潛在分銷合作夥伴外包進入工具(access tools)。鑑於該系統可能帶來的臨床優勢,我們對其前景仍感到非常振奮。

  • Now let's move on to our spinal cord stimulation percutaneous paddle lead program. As a reminder, this system is designed to offer broader customizable stimulation, lower energy consumption and can be inserted through a 14-gauge needle, eliminating the need for an incision in the patient's back.

    現在讓我們談談脊髓刺激(spinal cord stimulation)經皮槳狀導線(percutaneous paddle lead)計畫。提醒各位,該系統旨在提供更廣泛且可客製化的刺激、較低的能耗,並可透過 14 號針(14-gauge needle)置入,免除在患者背部切開傷口的需求。

  • During the quarter, we concluded our chronic animal study and identified opportunities to enhance performance. In addition, the system was also displayed at the North American Neuromodulation Society or otherwise known as NANS, and we received a great deal of interest from physicians that stopped by our booth.

    本季期間,我們完成了慢性動物研究(chronic animal study),並找出提升效能的機會。此外,該系統也在北美神經調控學會(North American Neuromodulation Society,亦稱 NANS)展出,我們的展位吸引了許多醫師駐足並表達高度興趣。

  • Finally, we also announced a CFO transition plan. Ron McClurg, who has served as our CFO with great distinction for over five years, will retire as CFO effective June 30, 2026, and remain a senior adviser to the company through year end. Effective July 1, 2026, Chris Volker, our current Chief Operating Officer, will assume the role of Chief Financial Officer.

    最後,我們也宣布一項財務長交接計畫。Ron McClurg 先生在過去五年多以卓越表現擔任本公司財務長,將於 2026 年 6 月 30 日起退休卸任財務長,並將以資深顧問身分留任至年底。自 2026 年 7 月 1 日起,現任營運長(Chief Operating Officer)的 Chris Volker 將接任財務長職務。

  • We are confident that this transition will be seamless and support continued execution against our strategic priorities. I also want to personally thank Ron for all his efforts, his commitment and his willingness to remain through this transition, and I am confident that Chris Volker is a great fit for this role.

    我們有信心此次交接將順利無縫,並支持我們持續執行既定策略重點。我也想親自感謝 Ron 付出的所有努力、承諾,以及願意在交接期間繼續留任;同時我也相信 Chris Volker 非常適合擔任此一職務。

  • I would now like to turn the call over to Ron to provide a review of our second quarter fiscal 2026 financial results.

    我現在想把電話交給 Ron,請他回顧我們 2026 會計年度第二季的財務結果。

  • Ronald McClurg - Chief Financial Officer

    Ronald McClurg - Chief Financial Officer

  • Thanks, Dave. Product revenue was $2.4 million in the second quarter of fiscal 2026, a 72% increase compared to product revenue of $1.4 million in the second quarter of fiscal 2025. The increase was driven by higher sales of OneRF products. For the six months ended March 31, 2026, product revenue was $5.3 million, an increase of 13% compared to $4.7 million in the same period of the prior fiscal year.

    謝謝,Dave。2026 會計年度第二季產品營收為 240 萬美元,較 2025 會計年度第二季的 140 萬美元成長 72%。此成長主要由 OneRF 產品銷售增加所帶動。截至 2026 年 3 月 31 日止六個月,產品營收為 530 萬美元,較上一會計年度同期的 470 萬美元增加 13%。

  • The company had no license revenue in the second quarter or first six months of fiscal 2026 compared to license revenue of $3 million in the first six months of fiscal 2025, which was derived from the expanded exclusive distribution agreement with Zimmer Biomet.

    公司在 2026 會計年度第二季及前六個月均無授權收入;相較之下,2025 會計年度前六個月的授權收入為 300 萬美元,該收入來自與 Zimmer Biomet 擴大之獨家經銷協議。

  • Product gross profit was $1.3 million or 53.8% of product revenue in the second quarter of fiscal 2026 compared to product gross profit of $0.8 million or 55.6% of product revenue in the same quarter of the prior fiscal year. For the six months ended March 31, 2026, product gross profit was $2.9 million or 54.0% of product revenue compared to $2.7 million or 57.9% of product revenue in the same period of the prior fiscal year.

    2026 會計年度第二季產品毛利為 130 萬美元,佔產品營收 53.8%;相較上一會計年度同季產品毛利為 80 萬美元,佔產品營收 55.6%。截至 2026 年 3 月 31 日止六個月,產品毛利為 290 萬美元,佔產品營收 54.0%;相較上一會計年度同期為 270 萬美元,佔產品營收 57.9%。

  • Total operating expenses were $3.4 million in the second quarter of fiscal 2026 compared to $3.5 million in the same quarter of the prior year. Research and development or R&D expense in the second quarter of fiscal 2026 was $1.5 million compared to $1.5 million in the same quarter of the prior year.

    2026 會計年度第二季總營業費用為 340 萬美元,較上一年度同季的 350 萬美元略降。2026 會計年度第二季研發(R&D)費用為 150 萬美元,與上一年度同季的 150 萬美元持平。

  • Selling, general, and administrative or SG&A expense in the second quarter of fiscal 2026 was $1.9 million compared to $1.9 million in the same quarter of the prior year. For the first six months of fiscal 2026, total operating expenses were $6.7 million compared to $6.7 million in the same period of fiscal 2025.

    2026 會計年度第二季銷售、一般及行政(SG&A)費用為 190 萬美元,與上一年度同季的 190 萬美元持平。2026 會計年度前六個月總營業費用為 670 萬美元,與 2025 會計年度同期的 670 萬美元持平。

  • R&D expense in the first six months of fiscal 2026 was $2.9 million compared to $2.7 million in the same period of fiscal 2025. SG&A expense in the first six months of fiscal 2026 decreased 4% to $3.8 million compared to $4.0 million in the prior year period.

    2026 會計年度前六個月研發費用為 290 萬美元,較 2025 會計年度同期的 270 萬美元增加。2026 會計年度前六個月 SG&A 費用較上一年度同期下降 4% 至 380 萬美元,上一年度同期為 400 萬美元。

  • Net loss in the second quarter of fiscal 2026 was $2.1 million or $0.25 per basic and diluted share compared to a net loss of $2.3 million or $0.44 per basic and diluted share in the same quarter of the prior year. The net loss in the second quarter of fiscal 2025 was favorably impacted by a $0.4 million gain from the fair value change in the warrant liability.

    2026 會計年度第二季淨損為 210 萬美元,或每股基本及稀釋虧損 0.25 美元;相較上一年度同季淨損 230 萬美元,或每股基本及稀釋虧損 0.44 美元。2025 會計年度第二季的淨損因認股權證負債公允價值變動產生 40 萬美元收益而受到有利影響。

  • For the six months ended March 31, 2026, net loss was $3.5 million or $0.42 per basic share and $0.44 per diluted share compared to a net loss of $0.5 million or $0.09 per basic and diluted share in the same period of the prior year. The lower net loss in the first six months of fiscal 2025 reflected a $3 million of license revenue recognized in the first quarter of fiscal 2025.

    截至 2026 年 3 月 31 日止六個月,淨損為 350 萬美元,或每股基本虧損 0.42 美元、每股稀釋虧損 0.44 美元;相較上一年度同期淨損 50 萬美元,或每股基本及稀釋虧損 0.09 美元。2025 會計年度前六個月淨損較低,反映 2025 會計年度第一季認列的 300 萬美元授權收入。

  • As of March 31, 2026, the company had cash and cash equivalents of $2.8 million compared to $6.6 million as of September 30, 2025. The company also had $2.4 million in accounts receivable as of March 31, 2026, which should be converted to cash in the third quarter of fiscal 2026 based on normal collection patterns.

    截至 2026 年 3 月 31 日,公司持有現金及約當現金 280 萬美元,較 2025 年 9 月 30 日的 660 萬美元減少。公司截至 2026 年 3 月 31 日亦有應收帳款 240 萬美元,依正常收款模式,預期將於 2026 會計年度第三季轉為現金。

  • The company had working capital of $5.7 million as of March 31, 2026, compared to working capital of $7.9 million as of September 30, 2025. NeuroOne had no debt outstanding as of March 31, 2026.

    截至 2026 年 3 月 31 日,公司營運資金為 570 萬美元,較 2025 年 9 月 30 日的 790 萬美元減少。截至 2026 年 3 月 31 日,NeuroOne 無任何未償債務。

  • Before I turn the call back to Dave for his closing remarks, I would like to thank Dave and the Board of Directors for giving me the opportunity to be part of such a talented team. It has been a privilege to serve as NeuroOne's Chief Financial Officer for over five years and to see the life-changing results our products are providing for patients.

    在我把電話交回給 Dave 進行結語之前,我想感謝 Dave 與董事會給我機會成為這個才華洋溢團隊的一員。能擔任 NeuroOne 財務長超過五年,並見證我們的產品為病患帶來改變人生的成果,是我的榮幸。

  • I look forward to watching the continued growth and success of NeuroOne.

    我期待看到 NeuroOne 持續成長並取得成功。

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Thank you, Ron. In summary, this was a very productive quarter for the company. We delivered 72% year-over-year product revenue growth, gained meaningful clinical experience with our OneRF trigeminal nerve ablation system, completed the Stage 2 ISO 13485 audit, paving the way for international distribution, regained Nasdaq compliance, and added two highly experienced executives and Dave Wambeke as Chief Business Officer; and effective July 1, Christopher Volker as our next Chief Financial Officer.

    謝謝你,Ron。總結來說,這一季對公司而言非常有成效。我們實現了產品營收年增 72%,在 OneRF 三叉神經消融系統上累積了具意義的臨床經驗,完成 ISO 13485 第二階段稽核,為國際經銷鋪路,恢復符合納斯達克規範,並新增兩位具高度經驗的高階主管以及任命 Dave Wambeke 為首席商務長;同時自 7 月 1 日起,Christopher Volker 將擔任我們下一任財務長。

  • Looking ahead, the catalysts are clear: continued commercial expansion of the OneRF brain ablation and OneRF trigeminal neuralgia ablation systems, commercial availability of our drug delivery system later this year, continued progress in our back pain technologies and future international commercial expansion. I am proud of what our team has built and believe we remain well positioned for the future. Finally, I look forward to sharing more of our story with investors at the Planet MicroCap Conference in Las Vegas in June.

    展望未來,催化因素相當明確:持續擴大 OneRF 腦部消融與 OneRF 三叉神經痛消融系統的商業化、我們的藥物遞送系統預計於今年稍晚開始商業供應、背痛技術的持續進展,以及未來的國際商業擴張。我為團隊所建立的一切感到自豪,並相信我們仍具備良好的未來布局。最後,我也期待在 6 月於拉斯維加斯舉行的 Planet MicroCap Conference 與投資人分享更多我們的故事。

  • With that, operator, at this time, we can open up the call for questions.

    那麼,接線員,現在我們可以開放提問。

  • Operator

    Operator

  • (Operator Instructions) Jeff Cohen, Ladenburg Thalmann.

    (接線員指示)Jeff Cohen,Ladenburg Thalmann。

  • Destiny Hance - Equity Analyst

    Destiny Hance - Equity Analyst

  • This is Destiny on for Jeff. Can we start with the drug delivery timing and strategy? I know you mentioned that it would be available for partnering and clinical evaluation in the second half of '26. So I'm curious what's left on your end to do?

    我是 Destiny,代 Jeff 發言。我們可以先從藥物遞送的時程與策略開始嗎?我知道你提到它會在 26 年下半年可供合作夥伴洽談與臨床評估。所以我想了解你們這邊還剩下哪些工作要完成?

  • And this is -- I think this is the first time I've heard you mention working with a distributor. Can you just walk us through that and that strategy a bit?

    另外,這是——我想這是我第一次聽到你提到與經銷商合作。你能否帶我們了解一下這件事,以及這個策略的概況?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Sure. And thanks for joining the call, Destiny. So really, what's left is for us to finish our sterilization testing and validation, and packaging. Once that's done, and it usually takes about three months, we'll be in a position to start shipping the product. And again, it's for any animal use as well as any approved human IDE studies.

    當然可以,也謝謝你加入電話會議,Destiny。基本上,我們剩下的工作是完成滅菌測試與驗證,以及包裝。一旦完成——通常大約需要三個月——我們就能開始出貨。再次強調,該產品可用於任何動物用途,以及任何已核准的人體 IDE 研究。

  • And we obviously don't have a direct sales force today. So the best way, we think, of really being able to commercialize the technology, at least initially for animal use is to identify the distributors that sell into those areas. So that's the plan there.

    而且我們目前顯然沒有直銷團隊。因此我們認為,至少在初期針對動物用途,要將這項技術商業化的最佳方式,是找出那些在相關領域銷售的經銷商。這就是我們的計畫。

  • And yes, I think you probably also heard that we just partnered with the University of Minnesota regarding some of the therapies that they would like to test. They're not the only healthcare system that's approached us. We expect to have more of those as well in the future.

    是的,我想你可能也聽說我們剛與明尼蘇達大學就他們想測試的一些療法建立合作。他們並不是唯一主動接洽我們的醫療體系;我們預期未來也會有更多這類合作。

  • Destiny Hance - Equity Analyst

    Destiny Hance - Equity Analyst

  • Okay. Got it. And then turning to face pain for a second. I'm wondering how that commercialization strategy has changed or evolved as you're getting more of these procedures done. And then I wanted to follow up on one of my questions from -- I think it was December about scheduling.

    好的,了解。接著談一下臉部疼痛。我想知道,隨著你們完成更多這類手術,你們的商業化策略如何改變或演進?另外我也想追問我之前的一個問題——我想是在 12 月時問到的,關於排程。

  • Are you seeing the same trends? I know you only had a couple when I asked the question originally, but are you seeing consistent trends with these physicians performing multiple ablations in different patients a day? Or has that kind of changed?

    你們看到的趨勢是否相同?我知道我最初問這個問題時你們只有少數案例,但現在你們是否看到一致的趨勢:這些醫師一天會在不同病患身上進行多次消融?還是這種情況有所改變?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • I'll answer the second question first. No, that's remained, and I expect that it will continue to be that way. It's a lot easier to really schedule these cases than it is the brain ablation cases because there's always the waiting period on the brain ablation cases to identify the focal area. Here, when the patient comes in, they know they're getting an ablation. So the neurosurgeons at the sites that we're at are stacking these cases in a day, and that makes it really easy to plan for that.

    我先回答第二個問題。不,這一直維持不變,而且我預期會繼續如此。相較於腦部消融病例,這些病例更容易真正排程,因為腦部消融病例總是需要等待期來辨識病灶焦點區域。而在這裡,病人一進來就知道他們要接受消融治療。因此,我們所在據點的神經外科醫師會把這些病例集中安排在同一天,這讓我們非常容易做規劃。

  • The commercialization strategy really hasn't changed. I still expect that we'll be partnering with another company. But until any agreement is final, we'll continue to do what we're doing, which is really opening up centers ourselves.

    商業化策略其實沒有改變。我仍然預期我們會與另一家公司合作。但在任何協議定案之前,我們會繼續做我們正在做的事,也就是自行開設中心。

  • Destiny Hance - Equity Analyst

    Destiny Hance - Equity Analyst

  • Got it. Okay. And then lastly, I just wanted to ask on guidance. I know you gave a top line of, I think it's $10.5 million for product revenue for 2026. I'm wondering if that outlook kind of remains the same.

    了解。好。最後我想問一下指引(guidance)。我知道你給了一個大方向,我想是 2026 年產品營收 1,050 萬美元。我想確認一下,這個展望是否大致維持不變。

  • And I know it did not include anything for drug delivery or facial pain. So I'm wondering if you can give us any updates there?

    而且我知道其中沒有包含任何藥物遞送或顏面疼痛的部分。所以我想請問你能否提供那兩方面的最新進展?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • It still remains the same, the guidance. And you're correct. It doesn't include anything from those areas. I think by the time we get to commercialize drug delivery, it will be late in our fiscal year. So I'm not expecting any major contributions from that area. And in terms of facial pain, it also really depends on how quickly we're able to finalize an agreement.

    指引仍然維持不變。你說得沒錯,並未包含那些領域的任何貢獻。我認為等到我們能將藥物遞送商業化時,會是在我們會計年度的較晚期,所以我不預期那個領域會有任何重大貢獻。至於顏面疼痛,則也很大程度取決於我們能多快把協議定案。

  • Operator

    Operator

  • Jeremy Pearlman, Maxim Group.

    Jeremy Pearlman,Maxim Group。

  • Jeremy Pearlman - Analyst

    Jeremy Pearlman - Analyst

  • Firstly, I wanted to speak a little bit about the international opportunity. You hope to get certification by the end of '26. Is that going to be -- is that commercial rollout going to be with Zimmer? Is that -- or is that potentially there with Zimmer?

    首先,我想談一下國際市場機會。你們希望在 26 年底前取得認證。那麼——商業化推廣會與 Zimmer 一起進行嗎?那——或是有可能會與 Zimmer 一起?

  • Or is it going to be through other distributors? And also maybe are there countries that you've targeted to be the first ones for that launch? Or maybe any update on that would be great?

    還是會透過其他經銷商?另外,是否有鎖定哪些國家作為首波上市的市場?如果能提供任何更新會很棒。

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Yes. Thanks for joining the call as well. So yes, the initial plan will be to enter international markets with Zimmer. In our agreement with Zimmer, they actually have certain geographies as part of the agreement, but there are some additional geographies that they don't have distribution rights to. So there is a chance that we will partner with other distributors for geographies that Zimmer has not signed up for.

    是的,也謝謝你加入這通電話。所以是的,初步計畫會與 Zimmer 一起進入國際市場。在我們與 Zimmer 的協議中,他們其實在協議裡涵蓋了特定地理區域,但也有一些額外地理區域他們沒有配銷權。因此,對於 Zimmer 未簽約的地區,我們有可能會與其他經銷商合作。

  • In terms of where we're going to focus on first, that's really in process right now with the Zimmer folks. The good news is that they're more than willing to help us help support any registrations or regulatory clearances that we need.

    至於我們會先聚焦在哪些地區,目前正與 Zimmer 團隊進行中。好消息是,他們非常願意協助我們,支持我們所需的任何註冊或法規核准。

  • But we are waiting to come up with a final list of at least the initial territories that we're looking to target. We would like to go to those geographies that accept FDA clearance so that there aren't any additional requirements for the company. But I expect next quarter to have more information on that.

    但我們仍在等待擬定最終清單,至少先確定我們要鎖定的初始區域。我們希望先去那些接受 FDA 核准的地區,這樣公司就不需要額外的要求。不過我預期下個季度會有更多相關資訊。

  • Jeremy Pearlman - Analyst

    Jeremy Pearlman - Analyst

  • Okay. Great. And then maybe, again, these are some KPIs. I don't know if you have all this information because I know it's sold a lot of it through Zimmer. Can you quantify how many procedures this quarter were performed by VP physicians versus, let's say, first-time users, so we can get some sense of how it's trending both within the current installed base and then potentially new users?

    好的,很好。接著也許——這些算是一些 KPI。我不確定你是否有所有這些資訊,因為我知道很多是透過 Zimmer 銷售的。你能否量化本季度由 VP 醫師執行的手術數量,相較於例如首次使用者的手術數量,讓我們能了解在既有裝機基礎內的趨勢,以及潛在新使用者的趨勢?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Yes, we don't have that information from Zimmer.

    是的,我們沒有從 Zimmer 那邊取得這項資訊。

  • Jeremy Pearlman - Analyst

    Jeremy Pearlman - Analyst

  • Okay. Understood. And I mean -- and then jumping to the trigeminal, is there -- could you remind us, I'm not sure if this information might have slipped my head. Is there a CPT code that covers that procedure? Or is it being billed under an existing CPT code? Maybe how should we look at the reimbursement landscape for the trigeminal ablation device?

    好的,了解。那我——再跳到三叉神經(trigeminal)這塊,能否提醒我們一下,我不確定是不是我漏掉了:是否有 CPT 代碼涵蓋該手術?還是目前是用既有的 CPT 代碼來申報?我們應該如何看待三叉神經消融裝置的給付(reimbursement)環境?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Yes. It is being built under an existing code. I don't -- in terms of what the code number is, I don't know that off the top of my head.

    是的,目前是用既有的代碼來申報。至於代碼號碼是多少,我一時想不起來。

  • Operator

    Operator

  • Justin Walsh, JonesTrading.

    Justin Walsh,JonesTrading。

  • Unidentified Pariticipant

    Unidentified Pariticipant

  • This is Bill on for Justin Walsh at Jones. We are curious on how are you driving new physician adoption for your OneRF system for facial pain.

    我是 Jones 的 Bill,代替 Justin Walsh 提問。我們想了解,你們如何推動新的醫師採用你們用於顏面疼痛的 OneRF 系統?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • I'm sorry, could you repeat the question? I just couldn't hear very clearly.

    不好意思,你可以重複一下問題嗎?我剛剛聽得不是很清楚。

  • Unidentified Pariticipant

    Unidentified Pariticipant

  • How are you driving new physician adoption for your OneRF system for facial pain?

    你們如何推動新的醫師採用你們用於顏面疼痛的 OneRF 系統?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Sure. So we're targeting centers that already have a generator at their facility. And if you remember, the surgeons that are performing the facial pain procedures are the same ones that are performing the brain ablation procedures. And I think if you look at the results to date, what we've said publicly is that 16 cases that we've currently done, all are pain-free.

    當然。我們鎖定的是那些院內已經有發生器(generator)的中心。如果你還記得,執行顏面疼痛手術的外科醫師,與執行腦部消融手術的是同一批人。我想如果你看目前為止的結果,我們公開說過:我們目前做的 16 例,全部都無痛(pain-free)。

  • So I think being able to really broadcast that data as we go to new sites that the system, in addition to seeing that so far, patients are pain-free, it also is a much more comfortable procedure for the patient because our device only has to be placed a single time as opposed to other existing technologies where the probe has to be placed multiple times until the neurosurgeon has found the area of the nerve that's triggering pain.

    所以我認為,隨著我們前往新的據點,能夠有效地傳播這些數據——除了目前看到病人都無痛之外,對病人而言這也是更舒適的手術,因為我們的裝置只需要放置一次;相較之下,其他既有技術往往需要多次放置探針,直到神經外科醫師找到引發疼痛的神經區域。

  • Because we have multiple contacts on the electrode, we can place it once and then test each of those contacts. So in other words, the patient doesn't have to get that probe placed multiple times. So that typically leads to shorter procedures and certainly a higher level of comfort.

    因為我們的電極上有多個接點(contacts),我們可以放置一次,然後測試每一個接點。換句話說,病人不需要多次放置探針。因此通常會帶來更短的手術時間,當然也會有更高的舒適度。

  • And the surgeons so far that we've gone to understand that and can appreciate it. So I don't think it's going to be that difficult to continue to show the advantages of our system.

    而且到目前為止我們接觸的外科醫師都理解並能認同這點。所以我不認為要持續展現我們系統的優勢會有多困難。

  • Unidentified Pariticipant

    Unidentified Pariticipant

  • Okay. And would you please expand on your timeline for your spinal cord stimulation percutaneous paddle program?

    好的。那你能否請你進一步說明你們脊髓刺激(spinal cord stimulation)經皮式槳葉(percutaneous paddle)計畫的時程?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • I'm sorry, again, I'm having a little trouble hearing. Could you repeat that?

    不好意思,我又有點聽不清楚。你可以重複一下嗎?

  • Unidentified Pariticipant

    Unidentified Pariticipant

  • Yes, of course. Would you expand on your timeline for your spinal cord stimulation percutaneous paddle program? What's the timeline for that program?

    好的,當然。你能否說明你們脊髓刺激經皮式槳葉計畫的時程?那個計畫的時間表是什麼?

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Yes. So we haven't put out a timeline yet. And now with some of the adjustments that we want to make, we'll have to figure out what that timeline is going to look like. But at this point, we're still trying to investigate the steps for what we want to do to make some enhancements on the system. So that will be something that we'll likely provide, I would assume, in the next one to two quarters.

    好的。我們目前還沒有公布時程。而且現在因為我們想做一些調整,我們必須再確認那個時程會長什麼樣子。但就目前而言,我們仍在研究我們想採取哪些步驟,來對系統做一些強化。因此這部分我們很可能會在接下來一到兩個季度提供,我想應該會是那個時間點。

  • Operator

    Operator

  • That appears to be the last question at this time. So I would like to turn the call back over to Mr. Dave Rosa for any closing remarks.

    看起來目前這是最後一個問題。因此我想把電話交回給 Dave Rosa 先生,請他做結語。

  • David Rosa - President, Chief Executive Officer, Director

    David Rosa - President, Chief Executive Officer, Director

  • Thank you, operator. I would like to thank everyone again for attending the call and look forward to connecting with the investor community throughout the quarter.

    謝謝,接線員。我想再次感謝各位參加本次電話會議,也期待在本季度期間持續與投資人社群保持聯繫。

  • If we were unable to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist.

    如果我們今天未能回答你的任何問題,請聯繫我們的投資人關係(IR)公司 MZ Group,他們將非常樂意提供協助。

  • Operator

    Operator

  • Thank you. Ladies and gentlemen, this concludes today's conference. We thank you for your participation, and you may disconnect your lines at this time, and we hope you have a great day.

    謝謝。各位女士、先生,今天的會議到此結束。感謝各位的參與。現在您可以掛斷電話線,並祝您有美好的一天。