Penumbra Inc (PEN) 2025 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Ladies and gentlemen, good afternoon. My name is Abby, and I'll be your conference operator today. At this time, I would like to welcome everyone to Penumbra's third-quarter 2025 conference call. (Operator Instructions)

    女士們、先生們,午安。我叫艾比,今天我將擔任你們的會議接線生。此時此刻,我謹代表 Penumbra 公司歡迎各位參加 2025 年第三季電話會議。(操作說明)

  • Thank you. And I would now like to introduce Ms. Cecilia Furlong, Business Development and Investor Relations for Penumbra. Ms. Furlong, you may begin your conference.

    謝謝。現在我謹向大家介紹 Penumbra 的業務發展和投資者關係負責人 Cecilia Furlong 女士。弗隆女士,您可以開始您的會議了。

  • Cecilia Furlong - Director of Business Development

    Cecilia Furlong - Director of Business Development

  • Thank you, operator, and thank you all for joining us on today's call to discuss Penumbra's earnings release for the third quarter of 2025. A copy of the press release and financial tables, which includes a GAAP to non-GAAP reconciliation, can be viewed under the Investors tab on our company website at www.penumbrainc.com. With me on today's call are Adam Elsesser, Chairman and CEO; Shruthi Narayan, President; and Maggie Yuen, Chief Financial Officer. Also joining us for the Q&A portion of the call is Jason Mills, EVP, Strategy.

    謝謝接線員,也感謝各位參加今天的電話會議,共同討論 Penumbra 公司 2025 年第三季的收益報告。新聞稿和財務報表(包括GAAP與非GAAP財務報表調節表)的副本可在公司網站www.penumbrainc.com的「投資者」欄位下查看。今天與我一同參加電話會議的有:董事長兼執行長Adam Elsesser;總裁Shruthi Narayan;以及財務長Maggie Yuen。參與本次電話會議問答環節的還有策略執行副總裁 Jason Mills。

  • During the course of this conference call, the company will make forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our financial performance, commercialization, clinical trials, regulatory status, quality, compliance and business trends. Actual results could differ materially from those stated or implied by our forward-looking statements due to certain risks and uncertainties, including those referenced in our 10-K for the year ended December 31, 2024, filed with the SEC.

    在本次電話會議期間,本公司將根據 1995 年《私人證券訴訟改革法案》的安全港條款作出前瞻性聲明,包括有關公司財務業績、商業化、臨床試驗、監管狀況、品質、合規性和業務趨勢的聲明。由於某些風險和不確定性,實際結果可能與我們的前瞻性聲明中所述或暗示的結果有重大差異,包括我們在截至 2024 年 12 月 31 日止年度向美國證券交易委員會提交的 10-K 文件中提及的風險和不確定性。

  • As a result, we caution you against placing undue reliance on these forward-looking statements, and we encourage you to review our periodic filings with the SEC, including the 10-K previously mentioned, for a more complete discussion of these factors and other risks that may affect our future results or the market price of our stock. Penumbra disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments or otherwise.

    因此,我們提醒您不要過度依賴這些前瞻性陳述,並鼓勵您查閱我們定期向美國證券交易委員會提交的文件,包括前面提到的 10-K 表格,以更全面地討論這些因素以及可能影響我們未來業績或股票市場價格的其他風險。Penumbra 聲明,對於因新資訊、未來事件、發展或其他原因而更新或修改我們的前瞻性聲明,我們沒有任何義務。

  • On this call, financial results for revenue and gross margin are presented on a GAAP basis, while operating expenses, operating income, and adjusted EBITDA are presented on a non-GAAP basis. The corresponding GAAP measures and a reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release.

    本次電話會議中,收入和毛利率的財務表現按美國通用會計準則 (GAAP) 列示,而營業費用、營業收入和調整後 EBITDA 則按非美國通用會計準則 (non-GAAP) 列示。相應的 GAAP 指標以及 GAAP 與非 GAAP 財務指標的調整表已在我們的新聞稿中提供。

  • Non-GAAP operating expenses and operating income exclude expenses related to the wind down of our Immersive Healthcare business in the third quarter of 2024 of $5 million and adjusted EBITDA excludes wind-down expenses, stock compensation expense, depreciation and amortization, provision for income taxes and interest income expenses.

    非GAAP營運費用和營運收入不包括與2024年第三季關閉沉浸式醫療保健業務相關的500萬美元費用,調整後的EBITDA不包括關閉費用、股票補償費用、折舊和攤提、所得稅準備金和利息收入費用。

  • And with that, I would like to turn the call over to Adam.

    接下來,我想把電話交給亞當。

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Cecilia. Good afternoon. Thank you for joining Penumbra's Third Quarter 2025 Conference Call. In the third quarter, we generated total revenue of $354.7 million, representing underlying year-over-year growth of 17.8% on a reported basis and 16.9% on a constant currency basis. Our strong third quarter results reflect broad-based execution against our strategy and significant progress in further enhancing our competitive technological and market positioning across all franchises.

    謝謝你,塞西莉亞。午安.感謝您參加 Penumbra 2025 年第三季電話會議。第三季度,我們實現了總營收 3.547 億美元,按報告匯率計算年增 17.8%,以固定匯率計算年增 16.9%。我們強勁的第三季業績反映了我們策略的全面執行,以及在所有業務領域進一步提升我們競爭性的技術和市場地位方面取得的重大進展。

  • Total US revenue was $275 million in the third quarter, an increase of 21.5% compared to the third quarter of 2024. Total US thrombectomy sales increased 18.5% year-over-year to $192 million. Our VTE franchise once again led overall corporate growth, delivering 34% year-over-year growth. US embolization across and access revenue of $83 million increased 29.2% year-over-year.

    第三季美國總營收為 2.75 億美元,比 2024 年第三季成長 21.5%。美國血栓切除術總銷售額年增 18.5%,達到 1.92 億美元。我們的VTE特許經營業務再次引領了公司整體成長,實現了34%的年成長。美國栓塞和介入收入為 8,300 萬美元,年增 29.2%。

  • Growth in our embolization and access business exceeded our expectations, reflecting the benefit of a dedicated peripheral embolization sales team alongside our investment in continuous innovation and new product introductions.

    我們的栓塞和通路業務成長超乎預期,這反映了我們擁有一支專業的周邊栓塞銷售團隊,以及我們對持續創新和新產品推出的投入所帶來的益處。

  • Internationally, the work we previously undertook to enhance our long-term market positioning is beginning to play out. We are now operating from a position of portfolio and geographic strength with our commercial execution in the quarter more than offsetting the China growth comp headwinds we continue to face. Total international revenue of $79.7 million increased 6.6% year-over-year or 3% in constant currency.

    在國際上,我們先前為提升長期市場地位所做的工作開始顯現成效。目前,憑藉強大的產品組合和地理優勢,我們本季的商業執行力足以抵消我們持續面臨的中國市場成長逆風。國際總營收為 7,970 萬美元,年增 6.6%,以固定匯率計算成長 3%。

  • Below the top line, gross margin of 67.8% expanded 130 basis points over the prior year period, and we delivered operating income of $48.8 million or 13.8% of revenue with our operating expense in the quarter, reflecting the full impact of our embolization sales force build-out. We remain on track and are well-positioned to achieve a gross margin profile of over 70% by the end of 2026 and expect operating margin expansion to outpace gross margin expansion for the foreseeable future as we prioritize delivering profitable growth and an expanding profitability profile.

    在營收方面,毛利率為 67.8%,比去年同期成長了 130 個基點;本季營業收入為 4,880 萬美元,佔營收的 13.8%(扣除營業費用後),這反映了我們栓塞銷售團隊建設的全面影響。我們仍按計劃推進,並預計在 2026 年底實現 70% 以上的毛利率。我們預計,在可預見的未來,營業利潤率的成長速度將超過毛利率的成長速度,因為我們將優先實現獲利成長和不斷提高獲利能力。

  • Turning to our US peripheral business. Our third quarter thrombectomy performance reflected both the clinical benefit and competitive strength of our CAVT technology alongside enhanced commercial focus from our now peripheral thrombectomy dedicated sales force. We delivered the highest sequential quarterly increase in VTE case volume growth to date in 2025. Our US arterial business also delivered another strong performance with the combination of Bolt 7 and Bolt 6X supporting further physician conversion from open surgery or the use of lytics to CAVT.

    接下來談談我們在美國的周邊業務。第三季血栓切除術的表現反映了我們 CAVT 技術的臨床益處和競爭優勢,以及我們現在專注於週邊血栓切除術的銷售團隊所加強的商業關注。2025 年,我們實現了 VTE 病例數季度環比增長的最高水準。我們的美國動脈業務也取得了又一次強勁的業績,Bolt 7 和 Bolt 6X 的組合進一步支持醫生從開放性手術或使用溶栓劑轉向 CAVT。

  • Penumbra received FDA clearance during the third quarter for both Lightning Bolt 16 and Lightning Flash 3.0. Lightning Bolt 16 brings proprietary modulated aspiration technology to our 16 French system and Flash 3.0 improves the fidelity of the algorithm by updating both the hardware and the software. These new products significantly add to the growing portfolio of advanced CAVT devices, opening up a clear path for us to reach the over 800,000 patients in the US who suffer from VTE and arterial clot with our CAVT technology.

    Penumbra 在第三季度獲得了 FDA 對 Lightning Bolt 16 和 Lightning Flash 3.0 的批准。 Lightning Bolt 16 將專有的調變抽吸技術引入我們的 16 French 系統中,而 Flash 3.0 則透過更新硬體和軟體來提高演算法的保真度。這些新產品極大地豐富了我們不斷增長的先進 CAVT 設備產品組合,為我們利用 CAVT 技術為美國超過 80 萬名患有 VTE 和動脈血栓的患者提供服務開闢了一條清晰的道路。

  • I also want to remind everyone that the core technology in our CAVT products is protected by a robust patent portfolio. We recently secured a victory from the Court of Appeals for the Federal Circuit, which similarly and unanimously affirmed the Patent and Trademark Appeal Board's IPR decisions in validating several competitive patents challenged by Penumbra.

    我還要提醒大家,我們 CAVT 產品的核心技術受到強大的專利組合保護。我們最近在聯邦巡迴上訴法院取得了一場勝利,該法院同樣一致地確認了專利商標上訴委員會的IPR裁決,該裁決確認了Penumbra公司對幾項競爭性專利提出的質疑。

  • We will continue to vigorously defend all of our patents and IP for our CAVT technology. At the TCT and VIVA conferences, we presented the landmark results from STORM-PE, the prospective multicenter randomized controlled trial evaluating CAVT plus anticoagulation versus anticoagulation alone for the treatment of acute intermediate high-risk PE.

    我們將繼續大力捍衛我們所有與 CAVT 技術相關的專利和智慧財產權。在 TCT 和 VIVA 會議上,我們展示了 STORM-PE 的里程碑式結果,這是一項前瞻性多中心隨機對照試驗,旨在評估 CAVT 加抗凝血治療與單獨抗凝血治療在治療急性中高風險 PE 方面的療效。

  • Shruthi will provide additional detail on the trial and study outcomes in her prepared remarks. But needless to say, taking into account the medical community's reaction to the data, we are highly optimistic that STORM-PE will act as a major catalyst in positively impacting the treatment of PE while significantly increasing the number of patients receiving intervention with CAVT.

    Shruthi 將在事先準備好的演講稿中提供有關試驗和研究結果的更多細節。但毋庸置疑,考慮到醫學界對這些數據的反應,我們非常樂觀地認為,STORM-PE 將成為積極影響 PE 治療的主要催化劑,同時顯著增加接受 CAVT 幹預的患者數量。

  • In our US peripheral embolization business, our new Embo dedicated 50-plus member sales team delivered strong 21.2% sequential growth in embolization revenue in the quarter. We believe the team's performance this quarter and the enhanced focus across our comprehensive current coil portfolio represents a new phase of sustainable growth in our US embolization franchise. Shruthi will discuss how the integration of this new team is unfolding.

    在美國週邊栓塞業務方面,我們新成立的 Embo 專職銷售團隊(50 多名成員)在本季度實現了栓塞收入 21.2% 的強勁環比增長。我們相信,本季團隊的表現以及對我們目前全面的線圈產品組合的更加重視,代表著我們在美國栓塞業務可持續成長的新階段。Shruthi 將探討這支新團隊的整合進展。

  • Shifting to our Neurovascular business. Recent market trends in the macro US stroke market showed a slight decline in the third quarter. Notwithstanding that, our stroke thrombectomy portfolio delivered positive growth and share gain. Historically, new innovation has catalyzed the stroke market, and we are optimistic that with the anticipated introduction of Thunderbolt, we will see a similar dynamic play out. In neuro embolization, the recent interest we've seen in utilizing our Swift coil for MMA embolization continues to translate into extremely strong above-market procedure growth, further contributing to sustainable growth in the US embolization franchise.

    轉向我們的神經血管業務。美國中風市場宏觀趨勢近期在第三季略有下滑。儘管如此,我們的中風取栓產品組合仍實現了正成長和市佔率提升。從歷史上看,新的創新推動了中控台市場的發展,我們樂觀地認為,隨著 Thunderbolt 的即將推出,我們將看到類似的動態發展。在神經栓塞領域,我們最近看到的對使用我們的 Swift 線圈進行 MMA 栓塞的興趣持續轉化為遠超市場水平的強勁手術增長,進一步促進了美國栓塞業務的可持續增長。

  • Now I'd like to give you an update on Thunderbolt. In October, we submitted thorough responses to all the outstanding questions received from the FDA during the 510(k) review process. We are now in the stage where we address any final questions or provide any required clarifications to our answers. For obvious reasons, we'll be prudent in our discussion today about Thunderbolt. However, we remain excited about the prospect of introducing CAVT to the neurovascular field.

    現在我想向大家介紹一下 Thunderbolt 的最新情況。10 月份,我們對 FDA 在 510(k) 審查過程中提出的所有未決問題都作出了詳盡的答覆。現在我們進入了回答最後問題或對我們的答案進行必要澄清的階段。出於顯而易見的原因,我們今天在討論 Thunderbolt 時會保持謹慎。然而,我們仍然對將 CAVT 引入神經血管領域的前景感到興奮。

  • Overall, based on our third quarter performance and reflecting the trends we've seen in our business and our target markets highlighted previously, we are raising our revenue guidance for the year to $1.375 billion to $1.380 billion. We reiterate 20% to 21% year-over-year growth for 2025 for US thrombectomy.

    總體而言,根據我們第三季的業績,並考慮到我們業務和目標市場先前所展現的趨勢,我們將全年營收預期上調至 13.75 億美元至 13.8 億美元。我們重申,到 2025 年,美國血栓切除術的年增長率將達到 20% 至 21%。

  • Now I will turn the call over to Shruthi, who will discuss a few details on the expansion of our sales team as well as the STORM-PE trial.

    現在我將把電話交給 Shruthi,她將討論我們銷售團隊擴張的一些細節以及 STORM-PE 試驗。

  • Shruthi Narayan - President

    Shruthi Narayan - President

  • Thank you, Adam. Good afternoon, everyone. Starting off with an update on our recent commercial expansion initiatives. Based on the significant ramp in physician interest in CAVT we experienced throughout 2023 and 2024. Entering 2025, we made the strategic decision to build out an additional peripheral sales team to focus on our embolization business, enabling our existing peripheral sales team to shift exclusive focus to CAVT. Through the first half of 2025, we added over 50 new peripheral embolization sales reps under our existing peripheral sales leadership team.

    謝謝你,亞當。大家下午好。首先向大家報告我們近期的商業擴張計劃。基於我們在 2023 年和 2024 年期間所經歷的醫生對 CAVT 的濃厚興趣。進入 2025 年,我們做出了策略決策,組建一支額外的周邊銷售團隊,專注於我們的栓塞業務,使我們現有的周邊銷售團隊能夠將全部精力轉移到 CAVT 上。到 2025 年上半年,我們在現有周邊銷售領導團隊下新增了 50 多名周邊栓塞銷售代表。

  • The build-out and integration went extremely well with the new team fitting seamlessly into our organization. This allowed the team to execute the launch of Ruby XL while also maintaining our momentum in our established portfolio, achieving strong 21.2% sequential growth in embolization revenue in the third quarter.

    團隊的組建和整合過程非常順利,新團隊無縫融入了我們的組織。這使得團隊能夠在推出 Ruby XL 的同時,保持我們在現有產品組合中的成長勢頭,並在第三季度實現了栓塞收入強勁的 21.2% 的環比增長。

  • As we execute the shift in our commercial structure, our existing team helped integrate our new team and supported the transition of embolization case coverage across our accounts. This transition process will taper in the fourth quarter, well-positioning our teams to enter 2026 fully focused on their respective sales objectives, CAVT and embolization.

    在我們執行商業結構轉變的過程中,我們現有的團隊幫助新團隊融入,並支持了我們所有客戶栓塞病例覆蓋範圍的過渡。這個過渡過程將在第四季度逐漸減弱,使我們的團隊能夠更好地進入 2026 年,全力專注於各自的銷售目標、CAVT 和栓塞治療。

  • Turning to STORM-PE. At the TCT conference early last week, Dr. Rob Lookstein presented the study's primary endpoints alongside key safety data. Additional secondary endpoint data, including key physiological and functional outcomes was presented by Dr. Rachel Rosovsky at VIVA earlier this week. The trial proved CAVT superior in reducing right heart strain in intermediate high-risk PE patients with a comparable safety profile to the current standard of care.

    轉向 STORM-PE。在上週初的 TCT 會議上,羅伯·盧克斯坦博士介紹了該研究的主要終點以及關鍵的安全數據。本週早些時候,Rachel Rosovsky 博士在 VIVA 會議上介紹了其他次要終點數據,包括關鍵的生理和功能結果。試驗證明,CAVT 在降低中高風險 PE 患者的右心負荷方面優於目前的標準治療,且安全性與目前的標準治療相當。

  • In addition, while not powered to show statistical significance on secondary endpoints, the trial data demonstrated statistical significance in favor of CAVT across multiple secondary endpoints. In addition, the initial trial results were published in circulation on Monday.

    此外,雖然該試驗並未充分統計次要終點的統計學意義,但試驗數據表明,CAVT 在多個次要終點方面具有統計意義。此外,初步試驗結果已於週一公佈。

  • STORM-PE proved CAVT superior to the current standard of care across the primary as well as multiple secondary endpoints showing CAVT patients recovered earlier and have significant long-term improvement in functional outcomes. The trial also highlighted the ability of the field's most advanced technology to deliver faster procedure and device times, reestablishing the baseline and expectations around acceptable case times.

    STORM-PE 證明 CAVT 在主要終點和多個次要終點方面均優於目前的標準治療,顯示 CAVT 患者恢復更快,功能結果有顯著的長期改善。該試驗也突顯了該領域最先進的技術能夠加快手術和設備使用時間,重新確立了可接受的手術時間基準和預期。

  • With procedures in the trial requiring minimal prior experience with Flash ahead of enrolling patients in STORM-PE, the strong results also highlight CAVT's ease of use and exceptional safety profile. The physician feedback across the interventional and non-interventional community has been enthusiastically positive. Since the presentations, we are seeing a shift to CAVT from older mechanical thrombectomy options for PE. We expect to see this continue. We are also working with societies and organizations to disseminate the now published data from STORM-PE to hospitals so they can update their current hospital protocols.

    STORM-PE 試驗中,患者在入組前對 Flash 的使用經驗要求極低,因此試驗結果也凸顯了 CAVT 的易用性和卓越的安全性。介入治療和非介入治療領域的醫生們都給予了非常正面的回饋。自從那次演講以來,我們看到肺栓塞的治療方案正在從較老的機械血栓切除術轉向 CAVT。我們預計這種情況會持續下去。我們也與各協會和組織合作,將 STORM-PE 現已發布的數據傳播給各醫院,以便他們能夠更新其目前的醫院規程。

  • Over the next year, this will be one of our top priorities. We are executing at a high level across our peripheral and neuro business units and are well-positioned to continue to build off our groundwork to date. As we look towards 2026 and beyond, we remain highly confident in our long-term strategy grounded in meaningful innovation, data generation, and investment in our team, supporting durable, profitable growth and the ability to treat a significant number of patients with our technologies.

    在接下來的一年裡,這將是我們的首要任務之一。我們在周邊和神經業務部門都保持著高水準的執行力,並已做好充分準備,繼續鞏固我們迄今為止的成果。展望 2026 年及以後,我們對以有意義的創新、數據生成和對團隊的投資為基礎的長期策略仍然充滿信心,這將支持持久的盈利增長,並使我們能夠利用我們的技術治療大量患者。

  • I'll now turn the call over to Maggie to go over our financial results for the third quarter of 2025.

    現在我將把電話交給瑪姬,讓她來介紹我們2025年第三季的財務表現。

  • Maggie Yuen - Chief Financial Officer

    Maggie Yuen - Chief Financial Officer

  • Thank you, Shruthi. Good afternoon, everyone. Today, I will discuss the financial results for the third quarter of 2025. Financial results on this call for revenue and gross margin are on a GAAP basis, while operating expenses, operating income, and adjusted EBITDA are on a non-GAAP basis. The corresponding GAAP measures and a reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release.

    謝謝你,Shruthi。大家下午好。今天,我將討論2025年第三季的財務表現。本次電話會議中,收入和毛利率的財務表現以 GAAP 為基礎,而營業費用、營業收入和調整後 EBITDA 則以非 GAAP 為基礎。相應的 GAAP 指標以及 GAAP 與非 GAAP 財務指標的調整表已在我們的新聞稿中提供。

  • For the third quarter ended September 30, 2025, our total revenues were $354.7 million, an increase of 17.8% reported and 16.9% in constant currency compared to the third quarter of 2024. Our geographic mix of sales for the third quarter of 2025 was 77.5% US and 22.5% international.

    截至 2025 年 9 月 30 日的第三季度,我們的總收入為 3.547 億美元,與 2024 年第三季度相比,按報告匯率計算增長了 17.8%,按固定匯率計算增長了 16.9%。2025 年第三季度,我們的銷售額地理構成中,美國佔 77.5%,國際佔 22.5%。

  • Our US region reported growth of 21.5%, driven by 18.5% growth in our thrombectomy franchise and 29.2% growth in embolization and access, driven by our Ruby XL product compared to the same period last year. As we previously shared, due to easing of China's headwind and double-digit growth for the remaining international regions, our international business has returned to growth, increasing by 6.6% reported and 3% in constant currency compared to the same period last year.

    與去年同期相比,我們美國地區的業績成長了 21.5%,這主要得益於血栓切除術業務成長了 18.5%,以及栓塞和通路業務成長了 29.2%,這主要得益於我們的 Ruby XL 產品。正如我們之前分享的那樣,由於中國市場不利因素的緩解以及其他國際地區兩位數的增長,我們的國際業務已恢復增長,按報告匯率計算增長了 6.6%,按固定匯率計算增長了 3%,與去年同期相比。

  • Moving to revenue by product. Revenue from our global thrombectomy business grew to $236.4 million in the third quarter of 2025, an increase of 15.8% reported and 15.1% in constant currency compared to the same period last year. The growth was primarily driven by an increased 18.5% increase in our US thrombectomy business.

    按產品劃分收入。2025 年第三季度,我們全球血栓切除業務的營收成長至 2.364 億美元,按報告匯率計算成長 15.8%,以固定匯率計算成長 15.1%,與去年同期相比。成長主要得益於我們在美國血栓切除術業務成長了 18.5%。

  • As expected, our international thrombectomy revenue also increased by 5.6% when compared to the same period last year. Revenue from our embolization and access business was $118.3 million in the third quarter of 2025, an increase of 22% reported and 20.8% in constant currency compared to the same period last year, primarily driven by an increase in US peripheral embolization sales due to the momentum from our successful launch of Ruby XL, combined with strategic investment we made in expanding our US embolization team in the first half of the year.

    正如預期的那樣,與去年同期相比,我們的國際血栓切除術收入也增加了 5.6%。2025 年第三季度,我們的栓塞和通路業務收入為 1.183 億美元,與去年同期相比,按報告匯率計算增長了 22%,按固定匯率計算增長了 20.8%,這主要得益於美國外周栓塞銷售額的增長,這得益於我們成功推出 Ruby XL 的勢頭,以及我們在今年上半年栓塞團隊的戰略投資。

  • Gross margin for the third quarter of 2025 is 67.8% compared to 66.5% for the third quarter of 2024. And consistent with our expectations, we delivered sequential gross margin growth of 180 basis points, driven primarily by favorable regional mix, product mix, and productivity improvements. We are very pleased at how quickly the team stabilized our Ruby XL build, of which our Ruby XL product has an accretive impact on our gross margin and the sales model supports a more efficient working capital dynamic. In addition, we are on track to achieve our full year gross margin targets and remain well-positioned to deliver our long-term gross margin profile of 70% by the end of 2026.

    2025 年第三季的毛利率為 67.8%,而 2024 年第三季的毛利率為 66.5%。正如我們預期的那樣,我們實現了毛利率環比增長 180 個基點,這主要得益於有利的區域組合、產品組合和生產效率的提高。我們非常高興團隊能夠如此迅速地穩定我們的 Ruby XL 構建,我們的 Ruby XL 產品對我們的毛利率產生了增值影響,並且銷售模式支持更有效率的營運資本動態。此外,我們預計將實現全年毛利率目標,並保持良好勢頭,在 2026 年底前實現 70% 的長期毛利率目標。

  • Now on to our non-GAAP operating expenses, non-GAAP operating income and margin and adjusted EBITDA. Total operating expense for the quarter was $191.6 million or 54% of revenue, compared to $160 million or 53.1% of revenue for the same quarter last year. Our research and development expenses for Q3 2025 were $22.7 million or 6.4% of revenue compared to $22.6 million or 7.5% of revenue for Q3 2024, which reflects savings of $3.6 million due to our Immersive business wind down, offset by continued investment in product development.

    接下來是我們的non GAAP營業費用、non GAAP營業收入和利潤率以及調整後的EBITDA。本季總營運支出為 1.916 億美元,佔營收的 54%,去年同期為 1.6 億美元,佔營收的 53.1%。2025 年第三季度,我們的研發費用為 2,270 萬美元,佔營收的 6.4%,而 2024 年第三季為 2,260 萬美元,佔營收的 7.5%。這反映了由於我們的沉浸式業務逐步結束而節省的 360 萬美元,但被對產品開發的持續投資所抵消。

  • SG&A expenses for Q3 2025 were $168.9 million or 47.6% of revenue compared to $137.4 million or 45.6% of revenue for Q3 2024. As we have stated previously, we have made targeted hires in our commercial and market access teams, which will support customer demand and allow us to capitalize on long-term growth drivers. Sequentially, our SG&A expenses increased by $8.9 million, reflecting the full quarter presence of our embolization sales team investment along with other variable spend.

    2025 年第三季銷售、一般及行政費用為 1.689 億美元,佔營收的 47.6%,而 2024 年第三季為 1.374 億美元,佔營收的 45.6%。正如我們之前所說,我們已在商業和市場准入團隊中進行了有針對性的招聘,這將有助於滿足客戶需求,並使我們能夠利用長期成長動力。與上一季相比,我們的銷售、一般及行政費用增加了 890 萬美元,這反映了我們栓塞銷售團隊投資的整個季度以及其他可變支出。

  • With this build-out now complete, we are positioned to capture sales and operation leverage in future quarters. We recorded operating income of $48.8 million or 13.8% of revenue compared to an operating income of $40.3 million or 13.4% of revenue for the same period last year. We posted adjusted EBITDA of $66.7 million or 18.8% of total revenue compared to $56.7 million or 18.8% in the third quarter last year.

    隨著這項建設工作的完成,我們已做好準備,在未來幾季獲得銷售和營運方面的槓桿效應。本年度營業收入為 4,880 萬美元,佔總收入的 13.8%,而去年同期營業收入為 4,030 萬美元,佔總收入的 13.4%。我們公佈的調整後 EBITDA 為 6,670 萬美元,佔總營收的 18.8%,而去年第三季為 5,670 萬美元,佔總營收的 18.8%。

  • Turning to cash flow and balance sheet. We ended the third quarter of 2025 with cash, cash equivalents, and marketable security balance of $470.3 million and no debt, which is an increase of $45.7 million sequentially. This increase includes improving working capital ratios in both receivable and inventory turns and strong profitability. We continue to expect positive operating cash flow trends to continue in 2025 and beyond.

    接下來分析現金流量表和資產負債表。截至 2025 年第三季末,我們的現金、現金等價物和有價證券餘額為 4.703 億美元,且無債務,比上一季增加了 4,570 萬美元。這一增長包括應收帳款和存貨週轉率的提高以及強勁的盈利能力。我們預計2025年及以後,積極的經營現金流趨勢將持續維持。

  • Turning to 2025 guidance. As Adam previously stated, we are raising our revenue guidance for the year to $1.375 billion to $1.380 billion. We reiterate 20% to 21% year-over-year growth for 2025 for US thrombectomy. Finally, we remain -- we maintain our previously stated 2025 gross and operating margin expansion guidance.

    接下來展望2025年的發展方向。正如亞當之前所說,我們將今年的營收預期上調至 13.75 億美元至 13.8 億美元。我們重申,到 2025 年,美國血栓切除術的年增長率將達到 20% 至 21%。最後,我們仍然維持先前公佈的 2025 年毛利率和營業利潤率成長預期。

  • This concludes our prepared remarks. Operator, we can now open the call to questions.

    我們的發言稿到此結束。接線員,現在可以開始接受提問了。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Travis Steed, Bank of America.

    特拉維斯·斯蒂德,美國銀行。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Congrats on the good quarter. I'll start with Thunderbolt since it's topical. It sounds like you're a lot closer to approval than you were. I assume nothing surprising with the FDA back and forth. But just maybe how you're thinking about the product when it hits the market, how much share you can take and how much -- when investors will see the data from Thunderbolt? Anything else you can share on the FDA process would be helpful if you could have the product approved by year-end or not?

    恭喜你們本季業績出色。鑑於雷電技術比較熱門,我就先從它說起。聽起來你離獲得批准比之前更近了。鑑於美國食品藥物管理局(FDA)的反覆表態,我認為不會有任何意外發生。但或許你對產品上市時的看法,能獲得多少市場份額,以及投資人何時才能看到 Thunderbolt 的數據?如果您還能分享一些關於FDA審批流程的信息,以及產品能否在年底前獲得批准,那就太好了。

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • That's great. Thanks, Travis. A lot of nuances to that question. So let me try to cover as much as possible. Let's maybe start with the process and give a little additional color, and then we can talk about at a point in time of what happens subsequently. I know there's been a lot of comments and thoughts around the timing of the process. I want to maybe level set the process and the timing because there's some -- I think, some maybe misunderstanding.

    那太棒了。謝謝你,崔維斯。這個問題有很多細微之處。那麼,讓我盡量涵蓋所有內容。我們不妨先從過程入手,再補充一些細節,然後再討論之後發生的事。我知道大家對這個過程的時間安排有很多評論和想法。我想統一流程和時間安排,因為我覺得可能有些誤解。

  • Thunderbolt is a brand-new product. It doesn't -- it's not already approved. It doesn't -- it's not just seeking a new indication. So I know in the past, there's been comparables to products that have been already on the market that have a history, that have safety information that obviously, the FDA sees and collects. And all they're looking for is a new indication. That's a different time period usually, and those can be shorter.

    Thunderbolt 是全新產品。還沒有——它還沒有獲得批准。並非如此——它不僅僅是在尋求新的指標。所以我知道過去曾出現過與已上市產品類似的情況,這些產品有歷史記錄,有安全信息,顯然,FDA 會查看和收集這些信息。他們所期待的,只是一個新的跡象。那通常是不同的時間段,而且可能更短。

  • For products that are brand new, those processes, at least in our experience with the neuro division sometimes take a while. For example, this is not fundamentally different timing than our original RED 72 SILVER LABEL, which was an update on an existing product, but it was a new product with some new materials and so on. And it takes a while because the FDA, and I applaud them for this are incredibly thorough.

    對於全新的產品,至少根據我們在神經科學部門的經驗,這些流程有時需要一段時間。例如,這與我們最初的 RED 72 SILVER LABEL 在時間安排上並沒有本質上的不同,它是對現有產品的更新,但它是一款採用一些新材料等的新產品。而且這需要一段時間,因為美國食品藥物管理局(FDA)的審查非常細緻,我為此表示讚賞。

  • So there's nothing about this process and timing, but we're feeling at least hopeful and optimistic. Needless to say, without sharing competitive information about what does the launch look like. And obviously, we don't want to do that. We obviously are ready and to launch this product and are excited about it when that time comes that we can do that. So we'll stay optimistic. And again, got to have a little prudence until we have a clearance letter from giving you more sort of detail on that, okay?

    所以目前還沒有關於流程和時間的具體訊息,但我們至少感到充滿希望和樂觀。不言而喻,我們不會透露有關產品發布會的具體資訊。顯然,我們不想那樣做。我們顯然已經做好了推出這款產品的準備,並且非常期待時機成熟時能夠推出這款產品。所以我們會保持樂觀。再次提醒,在收到你的許可信之前,還是要謹慎一些,以便我們能提供更多細節,好嗎?

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Makes a lot of sense. And maybe a follow-up on the STORM-PE secondaries now that those are out earlier this week and you've had a chance to talk to doctors. Curious how you're thinking about kind of the impact to the market and acceleration of the market and the potential to kind of take share given your safety profile on the device.

    很有道理。既然 STORM-PE 二級篩檢結果已於本週稍早公佈,而且您也有機會與醫生交流,那麼或許可以跟進一下。很好奇您如何看待這款設備在安全性方面對市場的影響、市場加速發展以及搶佔市場份額的潛力。

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yeah. There's a couple of interesting and exciting things that have happened. One, the reaction to the data within the medical community has been really just incredibly positive. I think folks who were at either TCT or VIVA or both saw that, they felt it. The safety -- the endpoints, the primary endpoint and of course, the secondary endpoints are really, really positive and strong and will have a big impact on non-interventionalists as well.

    是的。發生了一些有趣又令人興奮的事情。第一,醫學界對這些數據的反應非常正面。我認為參加過 TCT 或 VIVA 的人,或者兩者都參加過的人,都看到了這一點,感受到了這一點。安全性-終點、主要終點以及次要終點都非常積極和有力,並且也會對非介入治療者產生重大影響。

  • But in addition, the safety profile of the product was really striking, and I think that's led to a number of interventionalists who have not traditionally used our product call and want to start doing cases and have done cases in the last really weeks since last Sunday, with our product really for the first time in multiple cases. So that momentum is exciting as the field moves from the older technology that sort of got the field started to sort of the more modern CAVT technology. And as it relates to the non-interventional community and sort of what that reaction is, which is really core to building this market and growing it, Shruthi maybe can give you some additional comments. She's had a number of conversations with people and can share her perspective.

    此外,該產品的安全性表現非常出色,我認為這促使許多以前從未使用過我們產品的介入醫生聯繫我們,希望開始進行手術,並且在過去幾週,從上週日開始,他們已經多次使用我們的產品進行手術,這確實是他們第一次在多個病例中使用我們的產品。因此,隨著該領域從早期技術發展到更現代的 CAVT 技術,這種發展勢頭令人振奮。至於與非干預主義群體以及他們的反應(這對於建立和發展這個市場至關重要),Shruthi 或許可以給你一些補充意見。她與許多人進行過交談,可以分享她的觀點。

  • Shruthi Narayan - President

    Shruthi Narayan - President

  • Yes. Thanks, Adam. So yes, on the non-interventional community, for example, specific conversations with like pulmonologists, hematologists, they're all now very happy that there's validation that right heart recovery then leads to the sort of 6-minute walk test progress that we saw in the functional outcomes. And so they're now doing the work to start updating protocols within their institutions and start to see more and more patients get access to care. That was a comment Dr. Rachel Rosovsky made on the podium right at the end of the presentation.

    是的。謝謝你,亞當。所以,是的,例如在非介入治療領域,與肺科醫生、血液科醫生等進行的具體對話中,他們現在都非常高興地看到,右心恢復確實能夠帶來我們在功能性結果中看到的 6 分鐘步行測試進展。因此,他們現在正著手更新各自機構內的規程,並開始看到越來越多的患者獲得醫療服務。這是瑞秋·羅索夫斯基博士在演講結束時在講台上發表的評論。

  • And now different physicians in the non-interventional community are looking at their own hospital protocols to make those updates. Just since the release of Rachel's presentation on Monday, I've had conversations myself with physicians that have had the same reaction. So I think it's really positive for the field and hopefully, it's going to open up access to care for a lot more patients.

    現在,非介入治療領域的不同醫生正在審視各自醫院的治療方案,以便進行這些更新。自從瑞秋週一發布演講以來,我自己也和一些醫生進行了交談,他們的反應和我一樣。所以我認為這對這個領域來說真的是件好事,希望它能讓更多病患獲得醫療服務。

  • Operator

    Operator

  • Robbie Marcus, JPMorgan.

    羅比馬庫斯,摩根大通。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Congratulations on a nice quarter. I wanted to touch on margins here. I'll stay away from the revenue questions. And reiterating gross margin and operating margin guide, just wondering how you're thinking about the ability to drive margins. Is it -- is Thunderbolt going to be a big component to get those moving higher versus where you were thinking originally? And how should we be thinking about the impact of tariffs and how that impacted full year '25 margins?

    恭喜你本季業績出色。我想在這裡談談邊際效應。我會避開有關收入的問題。再次重申毛利率和營業利潤率指引,只是想知道您是如何看待提高利潤率能力的。Thunderbolt 是否會成為推動價格上漲到你最初預期水準的重要因素?我們該如何看待關稅的影響,以及關稅對 2025 年全年利潤率的影響?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Let me start briefly and then Maggie can address most of this. All of our CAVT products have very, very strong margins. So all of them, whether it's just Thunderbolt or any of the other areas that we've just spent a lot of time talking about have the ability as that mix changes. The other thing is with our newest coil that we launched, that's also accretive. So I think we're feeling pretty good. But Maggie can maybe go through some of the more specifics.

    我先簡單說幾句,然後Maggie可以解答大部分問題。我們所有 CAVT 產品的利潤率都非常非常高。所以,無論是 Thunderbolt 還是我們剛才花了很多時間討論的其他領域,它們都能夠隨著這種混合方式的變化而改變。另外,我們最新推出的線圈也是積層製造的。所以我覺得我們感覺還不錯。但瑪吉或許可以詳細解釋一些細節。

  • Maggie Yuen - Chief Financial Officer

    Maggie Yuen - Chief Financial Officer

  • Yes, yes. Thanks. With the remaining factors, this quarter, you see favorable, especially on a regional mix standpoint since we have seen a lot of US growth, but continued product mix and also the recovery from the operation teams to stabilize our Ruby XL yield improvement and productivity. And for going into Q4, we'll continue to see this trend. I think we'll continue to see sequential improvement from product mix, regional mix, and productivity improvement and also some volume leverage. I think what we have seen in this quarter already reflected some tariff impact. We do not have material impact on tariff, although still a little bit, but the number and trend that we've seen has already reflecting absorbing those headwinds.

    是的,是的。謝謝。考慮到其他因素,本季情況較為有利,尤其是在區域組合方面,因為我們看到了美國市場的大幅成長,產品組合持續改善,營運團隊也恢復了正常運營,從而穩定了 Ruby XL 的產量和生產力。進入第四季度,我們將繼續看到這種趨勢。我認為我們將繼續看到產品組合、區域組合和生產效率的逐步提高,以及銷售方面的一些成長。我認為本季我們已經看到了關稅帶來的一些影響。雖然關稅方面仍有一些影響,但我們並未受到實質影響,而且我們看到的數量和趨勢已經反映出我們正在消化這些不利因素。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Great. Maybe just a quick follow-up. If I zoom in on thrombectomy, US and OUS, but I guess more specifically US here. It's been decelerating throughout the year. I imagine a lot of that has been pressure in the stroke market, offset by really strong venous growth, market growth and Penumbra growth. How do you think about -- is it fair to assume that it will continue to downward trend? Or do you think there might be a stabilization in stroke as we move out to '26 with venous offsetting that and returning it more towards accelerating growth?

    偉大的。或許只需要簡單跟進。如果我放大血栓切除術,US 和 OUS,但我想這裡更具體地說是 US。今年以來增速一直在放緩。我認為這很大程度上是由於中風市場的壓力造成的,但被靜脈疾病市場的強勁成長、市場成長以及Penumbra的成長所抵消。你認為-假設它會繼續呈下降趨勢是否合理?或者您認為隨著我們進入 2026 年,中風可能會趨於穩定,靜脈疾病會抵消這種影響,並使中風的發生率進一步上升?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yes. Robbie, thank you. And thanks for -- in the body of your question, sort of highlighting and pointing out the dynamic in the market. You're exactly accurate. Obviously, VTE has led the growth sort of quarter after quarter. And some of that's market growth, obviously, some significant share gain. I think arterial has also been very, very strong. Stroke over the last couple of quarters has definitely been the drag that notwithstanding, we've held our own and used that opportunity to continue to take share. So we're not negative there. We're not seeing a decline in our business. It's just not growing at the same rate, obviously.

    是的。羅比,謝謝你。感謝您在問題正文中強調並指出了市場的動態。你說得完全正確。顯然,VTE 已經連續幾季引領了成長。顯然,其中一部分是市場成長,一部分是顯著的市佔率提升。我認為動脈血氣也一直非常強烈。過去幾季的中風無疑是最大的拖累,儘管如此,我們還是保持住了自己的水平,並利用這個機會繼續擴大市場份額。所以,我們在這方面並不悲觀。我們的業務並沒有出現下滑。顯然,它的成長速度沒有那麼快。

  • Over the course of the many, many years we've been in the stroke market, we have seen this. This happens. This is not new, and you've known that from watching us for many, many years. It doesn't -- it comes in waves. It doesn't happen always linearly. So there's nothing at this moment to be particularly concerned about. I do think having new technology that's very, very novel, not sort of similar to others has usually been a pretty significant catalyst. And so that certainly could help. But even without that, the market typically sort of ebbs and flows a bit, and we would expect that to turn around. The fourth quarter is usually a growth quarter traditionally in terms of the volume that grows. But overall, I'm optimistic about the future. It just comes in these waves.

    多年來,我們一直深耕中風治療市場,也見證了這一點。這種事時有發生。這並非什麼新鮮事,你們多年來一直關注著我們,早就知道了。不是這樣的——它是一波一波地來的。它並非總是線性發展的。所以目前沒有什麼特別值得擔心的事。我認為,擁有非常新穎、與其他技術截然不同的新技術通常是一個非常重要的催化劑。所以這肯定會有幫助。但即便沒有這些因素,市場通常也會有一些波動,我們預期這種情況會好轉。第四季通常是成長季度,傳統上是指銷售成長。但總的來說,我對未來持樂觀態度。它就像一波又一波地襲來。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    拉里·比格爾森,富國銀行。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Congrats on the nice quarter here, Adam. Adam, I wanted to ask about Embo Access, which was -- in the US, which was extremely strong in Q3. And in fact, worldwide Embo Access grew faster than worldwide thrombectomy. So was there anything you would characterize as onetime in Q3? How much of the strength was Ruby XL versus Swift, which you called out? And going forward, should we expect Embo Access to now outpace thrombectomy? And I had one follow-up.

    恭喜你這季度業績不錯,亞當。Adam,我想問關於 Embo Access 的問題,這家公司在美國第三季表現非常強勁。事實上,全球範圍內的栓塞治療成長速度超過了全球的血栓切除術。那麼,第三季有沒有什麼事情是你認為是一次性的?你提到的Ruby XL相對於Swift的優勢究竟有多大?展望未來,我們是否應該預期栓塞治療會超越血栓切除術?我還有一個後續問題。

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yes. It's a great question. We're really -- to answer the immediate question, there was nothing onetime about this quarter. The two things that were really stood out in the US, which was what was driving that -- well, two things around the peripheral part of the business. One, we have a dedicated team for the first time in a while. So their focus is on that. Obviously, over the last few years, our focus with our peripheral team had been split between our coils and our thrombectomy, making it pretty hard to do both well.

    是的。這是一個很好的問題。要回答眼前的問題,我們真的——本季沒有任何一次性事件發生。在美國,真正突出的兩件事,也是推動這一趨勢的因素——其實是圍繞業務外圍的兩件事。第一,我們好久以來第一次擁有了一支專門的團隊。所以他們的重點就在於此。顯然,在過去的幾年裡,我們週邊血管團隊的精力分散在栓塞術和血栓切除術上,這使得我們很難把兩件事都做好。

  • So I think that bodes well for our future that the integration, as Shruthi said, was really seamless. And I'll be honest, I was incredibly impressed with every member of that team and the leadership of the sales team for getting to allow that to happen that way. It was -- it's not a normal process to be that seamless and it really was. So I think we're in really good shape. I think what this shows is that there's a huge market and appetite for our very distinctive products that are different than others on the market, and I think that will continue. And I said that in my prepared remarks.

    所以我認為這預示著我們的未來會很美好,正如Shruthi所說,這次整合非常順利。說實話,我對團隊中的每一位成員以及銷售團隊的領導層都印象深刻,他們促成了這件事的發生。確實如此——這並非一個正常的流程,但它確實如此。所以我覺得我們情況非常好。我認為這表明,市場對我們獨特的產品有著巨大的需求,這些產品與市場上其他產品截然不同,而且我認為這種情況還會持續下去。我在事先準備好的發言稿中也提到了這一點。

  • As it relates to the neuro side, I'm really fascinating to watch that. The growth continues to happen there. The number of cases that people are doing in general for MMA embolization has increased notably. And more and more people are moving to our product because of the safety profile of it compared to more traditional means of treatment. So I think we're pretty optimistic about this business. And I think together with the thrombectomy, they both become equal drivers of growth. Obviously, you're going to see a quarter -- the quarter that you launch a product have slightly bigger growth on a sequential basis. But overall, I think going forward, we're not going to be looking at that business is dragging down our growth. I think both Embo and thrombectomy will be an important part of our growth in '26 and beyond.

    至於神經系統方面,我真的非常感興趣。那裡的成長仍在繼續。總體而言,人們進行 MMA 栓塞手術的病例數量顯著增加。越來越多的人因為該產品的安全性優於傳統治療方法而選擇使用該產品。所以我覺得我們對這項業務相當樂觀。我認為,血栓切除術和血管成形術共同作用,成為促進血管成形術和血管成形術的同等重要因素。顯然,你會看到產品上市的那個季度,其環比成長會略微大一些。但總的來說,我認為展望未來,我們不會再把這項業務視為拖累我們成長的因素。我認為栓塞術和血栓切除術都將是我們2026年及以後發展的重要部分。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • That's helpful. Adam, one quick one on the guidance. It does look like the guidance implies a deceleration in Q4. So my question is why? And the guidance for the year, 15% to 16% for 2025 has about a 4% headwind from China. So I guess on a reported basis, that 15% to 16%, is there any reason why growth would slow next year?

    那很有幫助。亞當,關於指導方面,我還有一個簡短的問題。看起來,該指引似乎暗示第四季成長將放緩。所以我的問題是,為什麼?而今年的預期是 2025 年成長 15% 至 16%,但來自中國的經濟成長將帶來約 4% 的阻力。所以,根據報告的成長率(15%到16%)來看,明年成長放緩有什麼原因嗎?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yes. Look, I think we've been pretty clear about learning our lessons on guidance, not getting ahead of ourselves. I do not -- we're obviously not going to give sort of backdoor guidance, if you will, for 2026. I'm not going to do that. We'll give our guidance on the fourth quarter call. But obviously, if you listen carefully and you did to what we've just said about our business and where we stand, we feel particularly good about our -- where we stand, not just this quarter, but for a while to come well into next year and the years beyond.

    是的。你看,我認為我們已經很清楚地認識到,在指導方面,我們要吸取教訓,不要操之過急。我不會——我們顯然不會為 2026 年提供任何形式的幕後指導。我不會那樣做。我們將在第四季財報電話會議上給予業績指引。但顯然,如果你仔細聆聽,並且認真聽了我們剛才所說的關於我們業務和現狀的內容,我們對我們的現狀感到非常滿意——不僅是本季度,而且在未來一段時間內,甚至到明年及以後的幾年裡,我們都保持著良好的狀態。

  • Operator

    Operator

  • Joanne Wuensch, Citibank.

    Joanne Wuensch,花旗銀行。

  • Joanne Wuensch - Analyst

    Joanne Wuensch - Analyst

  • I want to dig a little bit into international sales, please. It seems based on your commentary that China headwinds are waning. At what stage are they done? And if we adjusted for said headwinds, what would OUS growth have been this quarter?

    我想稍微了解一下國際銷售方面的資訊。根據你的評論來看,中國帶來的不利影響似乎正在減弱。它們在哪個階段完成?如果考慮到上述不利因素,本季 OUS 的成長會是多少?

  • Maggie Yuen - Chief Financial Officer

    Maggie Yuen - Chief Financial Officer

  • Yes. I think pretty much by next year, early next year, a lot of our headwind will be very minimal. We do have some China revenue a little bit this year, but I wouldn't look at it as a headwind for next year. In terms of our international -- rest of the international region growth, we mentioned that other than outside of China, the rest of the international regions are growing in double digits. I think in the prior quarters, sometimes we have highlighted that thrombectomy part of the OUS a lot of time grow in the mid-teens. So that has been kind of our trend throughout this year and still a lot of growth momentum next year.

    是的。我認為到明年年初,我們的大部分不利因素都將變得非常小。我們今年確實有一些來自中國的收入,但我不認為這會對明年造成不利影響。就我們的國際業務-除中國以外其他國際區域的成長而言,我們提到,除中國以外,其他國際區域的成長率均為兩位數。我認為在前幾個季度,我們有時會強調,血栓切除術在 OUS 中的應用很多時候都在十幾歲左右增長。所以這算是我們今年以來的發展趨勢,明年仍將保持強勁的成長動能。

  • Operator

    Operator

  • Vijay Kumar, Evercore.

    Vijay Kumar,Evercore。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Congrats on the nice one here. Adam, maybe my first one for you on the STORM-PE. I think in the past, you alluded to STORM-PE is having the potential to change clinical practice. I'm curious now that we've seen the primary and secondary endpoints, is this enough to change practice? Should we start seeing an acceleration in procedures adoption? Or are there any sort of hurdles, if you will, on the adoption of thrombectomy treating PE cases?

    恭喜你買到這麼好的東西。Adam,這可能是我在 STORM-PE 上為你準備的第一份禮物。我認為你過去曾暗示過 STORM-PE 有可能改變臨床實踐。既然我們已經看到了主要終點和次要終點,我很好奇這是否足以改變實踐?我們是否應該看到醫療程序採用率加速上升?或者說,在使用血栓切除術治療肺栓塞病例方面是否有任何障礙?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yes. Look, I can only tell you what we have heard in the last week or so, lots and lots of conversations. I will tell you that a number of non-interventionalist. And I think Shruthi alluded to two pulmonologists that she's had personal conversations with and a number of other non-interventionals have indicated to us that they would be leading the effort in their particular hospitals to change the protocols based on this data. So I think the reaction -- the positive reaction to this data has been uniform just across interventionalists, non-interventionalists.

    是的。聽著,我只能告訴你我們最近一週左右聽到的情況,很多很多的談話。我會告訴你,有很多非干預主義者。我認為 Shruthi 提到了她曾私下交談過的兩位肺科醫生,還有一些其他非介入性醫生也向我們表示,他們將在各自的醫院牽頭,根據這些數據改變治療方案。所以我認為,無論是乾預主義者還是非干預主義者,對這些數據的反應都是一致的——積極的反應。

  • So now the work starts to get protocols in hospitals change. And usually, as we've said, you heard members of our steering committee say, guidelines sort of lag behind practice sometimes. So I think you'll see the behavior and the protocols in hospitals change and guidelines will follow that effort. But it's been really heartening to see the excitement around this and not just with interventionalists, but with non-interventionalists knowing that they now have a very strong alternative for when they know their patients need something more significant. So I think it's a good day for the field and a good moment in time, and we're very optimistic about that.

    所以現在的工作重點是改變醫院的規章制度。正如我們所說,你們也聽我們指導委員會的成員說過,通常情況下,指導方針有時會滯後於實踐。所以我認為你會看到醫院的行為和規章制度改變,相關指引也會跟著調整。但令人欣慰的是,大家對此感到非常興奮,不僅是介入治療專家,就連非介入治療專家也感到興奮,因為他們知道,當他們知道患者需要更重要的治療時,現在有了一個非常有效的替代方案。所以我認為這對這項運動來說是個好日子,也是一個好時機,我們對此非常樂觀。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Understood. And then maybe one P&L question. Gross margins up 180 basis points Q-on-Q, with SG&A growth was quite striking up 25%. Was there any timing benefit on -- or timing impact, if you will, on SG&A OpEx? Or is this number being proactive as you look at that pipeline, some of these new products coming to fruition?

    明白了。然後可能還會問一個損益方面的問題。毛利率較上季成長 180 個基點,其中銷售、管理及行政費用成長尤為顯著,達 25%。銷售、一般及行政營運支出(SG&A OpEx)是否有任何時間上的優勢或影響?或者,這個數字是否反映了您在考察產品線時所採取的積極主動的態度,即一些新產品即將問世?

  • Maggie Yuen - Chief Financial Officer

    Maggie Yuen - Chief Financial Officer

  • Yes. No, thanks for your question. On the operating expense side, most of the increases that you see is pretty much all from the investment of our embolization team and the commercial team structure. We have pretty much completed the investment or the build-out by the end of this quarter or last quarter. So going forward, we'll start to see more leverage and it will be -- the investment level will be lower than what you have seen earlier in the year.

    是的。不,謝謝你的提問。在營運費用方面,您看到的大部分成長幾乎都來自我們栓塞團隊和商業團隊結構的投資。到本季末或上個季度末,我們基本上已經完成了投資或建設工作。因此,展望未來,我們將看到更大的槓桿作用,而且投資水準將低於今年稍早的水準。

  • Operator

    Operator

  • Brandon Vazquez, William Blair.

    布蘭登·瓦茲奎茲,威廉·布萊爾。

  • Brandon Vazquez - Analyst

    Brandon Vazquez - Analyst

  • I wanted to stay on this STORM-PE train of thought for a minute, but I'll ask this question slightly different, but it sounds like there could be kind of an initial benefit from the current interventionalists performing more mechanical thrombectomy. But one of the other tertiary benefits that might come is really that like smaller hospitals that aren't using any thrombectomy at all today might start performing these procedures. We saw in the data that it was a very low learning curve, a lot of naive users in this trial.

    我想繼續探討 STORM-PE 的思路,但我會換個方式問這個問題,聽起來目前的介入醫生進行更多機械血栓切除術可能會帶來一些初步的益處。但其他可能帶來的額外好處之一是,像目前完全不使用血栓切除術的小型醫院可能會開始進行這些手術。我們從數據中看到,它的學習曲線非常低,本次試驗中有很多新手用戶。

  • So the question that I'll kind of frame here is like, one, talk to us a little bit about the time lines and your expectations of kind of turning on some of these accounts, how difficult or easy that might be? And then two, once your foot is in the door with PE treatment, are there other venous opportunities now that you've placed the lightning in these smaller hospitals that you could start to go after as well?

    所以我在這裡要問的問題是,第一,請您談談啟用這些帳戶的時間表和您的預期,以及這可能有多難或多容易?其次,一旦你在 PE 治療領域站穩腳跟,既然你已經在這些小型醫院裡開展了閃電療法,那麼現在是否還有其他靜脈治療的機會可以開始爭取呢?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yes. There's a lot to your question. So at a respectful time, I'll try to give you a fairly complete, but brief answer. There's so many layers of opportunity here. There's practices that are not treating everyone, which is the most of them who now will hopefully start to change their internal protocols. There are hospitals that don't really do intervention for PE that -- as you alluded to, that might now take it on. Sometimes that could also have a benefit because once you're doing PE, you really are sort of related to its cousin of DVT treatments.

    是的。你的問題包含的資訊很多。所以,我會找個合適的時間,盡量給你一個比較完整但又簡短的答案。這裡蘊藏著太多機會。有些醫療機構沒有為所有人提供治療,希望這些機構中的大多數現在能夠開始改變其內部規章制度。正如你所提到的,有些醫院以前並不真正對肺栓塞進行幹預治療,但現在可能會開始進行幹預治療。有時這樣做也有好處,因為一旦你開始進行肺栓塞治療,你實際上就和它的近親深部靜脈血栓治療有點關係了。

  • Some of those places are using our technology for arterial, for example, which is a little bit of a different dynamic. So there's some overlap. All in all, what it does is really put a spotlight on the newest technology, which is CAVT, the speed of those cases, the safety profile of those cases. In the past, as you know, we've talked about and presented really robust data on the health economics of that, which justifies doing this. It's a procedure that is clearly validated not only clinically but also economically. So I think it just really opens the door for a lot of people.

    例如,有些地方正在使用我們的技術進行動脈治療,這其中的情況略有不同。所以兩者之間存在一些重疊之處。總而言之,它真正突出了最新技術——CAVT,以及這些案件的處理速度和安全性。如您所知,過去我們已經討論並提出了關於這方面的健康經濟學的非常可靠的數據,這證明了這樣做是合理的。這項技術不僅在臨床上,而且在經濟上也得到了充分的驗證。所以我認為這確實為很多人打開了一扇門。

  • I personally had the experience at TCT of talking to a cardiologist who runs a very well-known national practice, but their group doesn't typically do PE. It's covered by another specialty in their hospital. And after hearing the data, they were particularly excited about getting in there, helping their colleagues, opening up the coverage capacity pretty dramatically. So -- and that was just one of many, many conversations. So it takes some time. It can't all happen in 1 quarter, but it puts us in a really good spot for 2026.

    我自己在 TCT 有過這樣的經歷:我和一位在全國享有盛名的心臟科醫生交談過,但他們的團隊通常不做肺栓塞治療。這屬於他們醫院的另一個專科負責。在聽取了相關數據後,他們非常興奮地加入進來,幫助他們的同事,從而大幅提升了覆蓋能力。所以——而這只是眾多對話中的一次。所以需要一些時間。這不可能在一個季度內全部實現,但這讓我們在 2026 年處於非常有利的位置。

  • Brandon Vazquez - Analyst

    Brandon Vazquez - Analyst

  • Okay. And a separate follow-up question here. Forgive me if you guys had kind of gone over these details already before, but this is the first I'm hearing a little bit more of Lightning Flash 3.0. Can you just spend a minute talking about timings for when that goes into a broader launch? How important it is? Where do you think we'll see the benefits of this 3.0 over 2.0?

    好的。這裡還有一個後續問題。如果你們之前已經討論過這些細節,請原諒,但這是我第一次聽到關於 Lightning Flash 3.0 的消息。能否花一分鐘時間談談它何時會全面發布?它有多重要?你認為3.0版本比較2.0版本有哪些優點?

  • Shruthi Narayan - President

    Shruthi Narayan - President

  • Yes. So with 3.0, as Adam alluded to on the prepared remarks, it is really a hardware and a software update. And what it does is it really improves the fidelity. And so what that means is these cases, as you saw from STORM-PE, 25-minute device times and really the fastest on the market right now, but Flash 3.0 is going to make it even faster, even better in terms of overall safety profile, blood mitigation, all the things that our physicians have now sort of come to expect. And so this really moves that even further forward by improving those case times even more.

    是的。正如亞當在準備好的演講稿中所提到的,3.0 版本實際上是一次硬體和軟體的更新。它的確能提高保真度。因此,這意味著,正如您在 STORM-PE 中看到的那樣,這些病例的治療時間為 25 分鐘,是目前市場上最快的,但 Flash 3.0 將使其速度更快,在整體安全性、血液緩解等方面表現更好,這些都是我們的醫生現在所期望的。因此,這確實透過進一步縮短案件處理時間,推動了案件處理工作向前發展。

  • Operator

    Operator

  • Bill Plovanic, Canaccord.

    Bill Plovanic,Canaccord。

  • William Plovanic - Equity Analyst

    William Plovanic - Equity Analyst

  • The first is going to be -- I understand on the guidance, you want to be conservative, but the high end of that guidance is up 2% sequentially. You did up 4.8% and 5.1% in last year and the year before. And I'm just trying to -- is there anything specific that you're concerned about that you're only guiding up 2% and not the 5% that would be in line with the past 2 years?

    首先,我理解你們在業績指引方面希望保持保守,但指引的上限是環比成長 2%。去年和前年你們的表現分別成長了 4.8% 和 5.1%。我只是想問——您具體擔心什麼,以至於只給出 2% 的漲幅預期,而不是過去兩年 5% 的漲幅預期?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Not something sort of I look at in all the various way you look at it. I look at what we beat by and what we raise by. And I think that's a pretty solid guide up. We're obviously not going to want to get ahead of ourselves, and there's so much positive work to do over the next period of time. Let's give us a chance to get started. Let's get going. We're only a week into STORM-PE. And I think we'll feel pretty comfortable. We got a couple of products to launch in peripheral and neuro is strong. Bear with us, we'll be good.

    這不是我會像你一樣從各種角度去看待的事情。我關注的是我們戰勝了什麼,以及我們增加了什麼。我認為這是一份相當不錯的指南。我們顯然不想操之過急,而且在接下來的這段時間裡還有很多積極的工作要做。給我們一個開始的機會。我們出發吧。STORM-PE 才開始一週。我想我們會覺得很舒服。我們在外圍設備和神經領域有幾款產品即將推出,而且它們表現強勁。請耐心等待,我們會沒事的。

  • William Plovanic - Equity Analyst

    William Plovanic - Equity Analyst

  • All right. And then just a follow-up again on the FDA. I truly appreciate the update, a lot of detail today. My question is, is the FDA requiring any additional testing and/or clinical data from you? Or is this a purely back and forth at this point?

    好的。然後,我又跟進了一下FDA的情況。我非常感謝這次更新,今天提供了許多細節。我的問題是,FDA是否要求您提供任何額外的測試和/或臨床數據?或者說,目前這只是雙方的來回爭論?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yes. So again, I want to remain prudent. I was pretty clear about that. The -- we -- what I said in my prepared remarks is we have already answered very thoroughly all the questions that we had received at that point. So that has already been done. They are now in the phase where they can obviously ask for clarifications or additional questions. But -- so I can't tell you what that's going to be yet. But we've been through, obviously, for a period of time here, very, very thorough questions like any new product that they review in the neuro division. So totally appropriate and not totally unexpected.

    是的。所以,我還是想保持謹慎。我對此已經說得很清楚了。正如我在事先準備好的演講稿中所說,我們已經非常詳盡地回答了當時收到的所有問題。這件事已經辦好了。他們現在顯然可以要求澄清或提出其他問題。但是——所以我現在還不能告訴你那會是什麼。但很顯然,我們已經在這裡進行了一段時間的非常非常徹底的提問,就像神經部門審查任何新產品一樣。完全合情合理,但也在意料之中。

  • William Plovanic - Equity Analyst

    William Plovanic - Equity Analyst

  • And is the shutdown impacting their responses? Or are they continuing to work through?

    政府停擺是否影響了他們的因應措施?還是他們還在繼續努力?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • As -- I can't speak to that on a sort of daily basis. But as of now, we have not experienced any sense of delay because of the shutdown. But obviously, that's a process that's in real time and continues. So I can't speak to that what might happen end of this week or next week or what have you.

    至於——我無法就此進行日常評論。但截至目前,我們尚未感受到因停工而造成的任何延誤。但很顯然,這是一個即時進行且持續的過程。所以我無法預測本週末、下週或其他時候可能會發生什麼。

  • Operator

    Operator

  • Michael Sarcone, Jefferies.

    Michael Sarcone,傑富瑞集團。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • There's been a lot of focus on STORM-PE and pulmonary embolism. Your US VTE business continues to grow at a healthy clip. Maybe you can give us kind of the latest and greatest trends on the DVT side of the business and how you're thinking about growth there?

    人們對 STORM-PE 和肺栓塞給予了許多關注。您的美國VTE業務持續保持健康成長動能。或許您可以為我們介紹一下DVT業務的最新發展趨勢,以及您如何看待這方面的成長?

  • Shruthi Narayan - President

    Shruthi Narayan - President

  • Thanks. That's a great question. So on the DVT side, what we're again seeing is just a positive response to Flash 2.0, we have commented on the VTE segment as a whole growing consistently the past several quarters, and that trend is expected to continue. And you're just going to see physicians as they hear about STORM results start adopting the technology on PE. And if they haven't yet used us on DVT, you're going to see that dynamic play out. So I think it just sets us up really well here for the future. Hopefully, that answers the question.

    謝謝。這是一個很好的問題。因此,在 DVT 方面,我們再次看到 Flash 2.0 獲得了正面的迴響。我們已經評論過,VTE 領域在過去幾個季度持續成長,預計這一趨勢還將繼續。你會看到,當醫生聽到 STORM 的結果後,就開始在肺栓塞治療中採用這項技術。如果他們還沒有讓我們參與治療深部靜脈血栓,你很快就會看到這種情況發生。所以我認為這為我們未來的發展奠定了非常好的基礎。希望這能解答你的疑問。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • That does. That's really helpful. And just one quick follow-up there. In the past, you've talked about DVT being a little bit different in that you're focused more on the health economic side and working in collaboration with some hospital accounts. I guess, do you still have a focus there? And are you going to continue to execute on that kind of health economic data on the DVT side?

    確實如此。這真的很有幫助。最後還有一個問題要補充。過去,您曾談到 DVT 有些不同,因為您更關注健康經濟方面,並與一些醫院客戶合作。我想,你現在仍然把重心放在那方面嗎?你們是否會繼續利用這類健康經濟學數據來研究深部靜脈栓塞(DVT)?

  • Shruthi Narayan - President

    Shruthi Narayan - President

  • Absolutely. We're starting to see those results get presented at different conferences, just some of the market access data sets, working with the Vizient and the Premier databases. So the physician community is starting to hear about that. We also have our hospital engagement team that is actively having conversations with different folks within the hospitals to communicate that information. And what you'll also see is, again, the benefit of STORM-PE applies to the overall sort of VTE segment. So you're just going to see more excitement within the hospital to treat these patients. The Level 1 evidence that's now available will help on the DVT side as well.

    絕對地。我們開始看到這些結果在不同的會議上展出,其中一些是市場准入資料集,與 Vizient 和 Premier 資料庫合作。所以醫生界開始聽到這些消息了。我們還有一個醫院聯絡團隊,他們積極與醫院內的不同人員溝通,以傳達這些訊息。而且您還會看到,STORM-PE 的好處同樣適用於整個 VTE 領域。所以你會看到醫院裡有更多的人充滿熱情地去治療這些病人。目前可取得的 1 級證據對 DVT 方面也有幫助。

  • Operator

    Operator

  • Pito Chickering, Deutsche Bank.

    皮托·奇克林,德意志銀行。

  • Pito Chickering - Analyst

    Pito Chickering - Analyst

  • A few follow-up, Peter, on US thrombectomy. Can you talk about market share versus market growth in the quarter? And can you quantify how many new accounts you added this quarter and how you see that in the fourth quarter post the STORM trial?

    Peter,關於美國血栓切除術,我還有一些後續問題。能否談談本季市佔率與市場成長率之間的關係?您能否量化一下本季新增了多少個帳戶,以及在 STORM 試驗之後,您如何看待第四季的情況?

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yeah. Obviously, we have -- there's comparative information out there with other companies. So obviously, a huge chunk of -- this is all before STORM, obviously, came out, but a huge chunk of that was market share. And I think that's known. It's not -- just number of new accounts isn't really the complete way to look at it because obviously, there are number of different physicians within each account.

    是的。顯然,我們有-可以查閱與其他公司的比較資訊。顯然,這很大一部分——這顯然都是在《風暴》發布之前——但很大一部分是市場份額。我想這一點大家都知道。並非如此——僅僅看新帳戶的數量並不能全面反映情況,因為顯然每個帳戶中都有許多不同的醫生。

  • Some use one product and other uses another. So there's mix between that. So that's not a good measure. But when we look at the people who were using something and switched to us, that has continued all year long, obviously, at the end of last year and all the way through this year.

    有些人使用一種產品,有些人使用另一種產品。所以兩者之間存在著混合。所以這不是一個好的衡量標準。但當我們觀察那些之前使用其他產品後來轉而使用我們產品的用戶時,很明顯,這種情況持續了一整年,從去年年底一直持續到今年年底。

  • And really, what was surprising was, I guess, not surprising, but pleasant to see is just in the last week, because of the data and the safety profile as one of the cited reasons for their switch, we saw people who have moved from older technology to newer and all signs are that, that will continue.

    而真正令人驚訝的是,我想,這或許並不令人驚訝,但令人欣喜的是,就在上週,由於數據和安全狀況(這是他們轉換的原因之一),我們看到人們從舊技術轉向了新技術,而且種種跡象表明,這種情況還會繼續下去。

  • So I think it's a combination going forward of continued share shift from older type of technology to the newer CAVT and what will play out, I think, over the next year or so is the increase in the number of patients treated. And I think they're tied. DVT and PE play into each other that way. And I think you're going to see some growth over the next two, three years.

    所以我認為,未來一段時間內,市佔率將繼續從舊式技術轉移到新型 CAVT ,而未來一年左右,接受治療的患者人數將會增加。我認為他們打成平手。深部靜脈血栓形成和肺栓塞就是這樣相互影響的。我認為未來兩三年你會看到一些成長。

  • Pito Chickering - Analyst

    Pito Chickering - Analyst

  • Okay. If I step back and look at market growth, how many PER teams do you think were created this year? And how do the from hospitals look post storm trials? There seem to be a lot of excitement last week at TCT about starting more programs.

    好的。如果我退後一步,從市場成長的角度來看,你認為今年創造了多少支 PER 團隊?風暴過後,醫院的狀況如何?上週,TCT 似乎對啟動更多項目感到非常興奮。

  • Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

    Adam Elsesser - Chairman of the Board, President, Chief Executive Officer

  • Yeah. I think, look, there's two different groups of PER teams. There's the formal PER teams that are also members of the PERT consortium. And then there are lots and lots of sort of local PER teams that aren't -- haven't joined the PERT consortium. Some of the times, smaller hospitals are just newer in the process. What I was very pleased to see is at the beginning of TCT, the PERT Consortium announced a pretty significant effort over the next couple of years to dramatically increase the number of members of their consortium as well as really help get sort of with the most current technology and the idea that these people can be helped in a different way.

    是的。我認為,你看,PER 團隊可以分為兩大類。還有正式的PER團隊,他們也是PERT聯盟的成員。此外,還有很多地方性的PER團隊沒有加入PERT聯盟。有些時候,規模較小的醫院只是成立時間較短而已。令我非常高興的是,在 TCT 會議伊始,PERT 聯盟宣布將在未來幾年內做出相當大的努力,大幅增加其聯盟成員的數量,並真正幫助人們掌握最新的技術,以及以不同的方式幫助這些人的想法。

  • So I think there's a lot of energy ready to go and coming out of the TCT meeting and also at VIVA, that was really clear that people are going to have either informal PERT programs, which is a cross-functional group of people caring about these patients differently or formalize them and be part of the PERT consortium. Either way, I think we're seeing a huge change in energy and focus around pulmonary embolism patients.

    所以我認為,從 TCT 會議和 VIVA 會議來看,已經有很多能量準備就緒,這非常清楚,人們要么會建立非正式的 PERT 項目(這是一個由關心這些患者不同方式的人員組成的跨職能小組),要么會將其正式化並成為 PERT 聯盟的一部分。無論如何,我認為我們正在看到人們對肺栓塞患者的關注和重視程度發生了巨大變化。

  • Operator

    Operator

  • Ryan Zimmerman, BTIG.

    Ryan Zimmerman,BTIG。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • I appreciate that very much. So I'll ask the two questions upfront. We haven't talked much about the interim update on STRIKE-PE out of TCT. And I'm wondering if you can kind of give us your high-level thoughts, Adam, on that. We looked at the data, good kind of RV/LV changes. But I think certainly, there are some other aspects to it that may have stuck out or been on people's minds. I'm curious to kind of get your high-level thoughts.

    我非常感謝。所以我先問這兩個問題。我們還沒有過多討論 TCT 發布的 STRIKE-PE 的中期更新。亞當,我想知道你是否可以就此談談你的看法。我們查看了數據,發現右心室/左心室發生了良好的變化。但我認為,肯定還有其他一些方面可能更引人注目或引起了人們的注意。我很想了解你的整體想法。

  • And then the other question is just directed to Shruthi, which is embolization and access, you talked about it. These markets typically don't grow at the kind of rates that you're seeing. And so is it just the products themselves? Is it higher use of MMA? I'm just curious if you could kind of talk specifically about what is going to drive this durably for the time being.

    另一個問題是問 Shruthi 的,是關於栓塞和路徑的問題,你之前談過。這些市場通常不會以你現在看到的這種速度成長。所以問題僅僅出在產品本身嗎?MMA的使用率更高嗎?我只是好奇,您能否具體談談目前是什麼因素會持續推動這一趨勢。

  • Shruthi Narayan - President

    Shruthi Narayan - President

  • Yes. Great questions. So on the first one there with STRIKE-PE, just like you commented on, I mean, there's obviously STORM-PE is kind of the highlight right now, but STRIKE-PE certainly confirms the longer-term benefit of CAVT. As you may recall, that study goes out to one year and looks at functional outcomes. Longer term, how do these patients do out to one year. And so it just adds to the overall body of evidence. At VIVA, there was a specific subset presented on just the use of the Flash product in these patients and their follow-up out to one year.

    是的。問得好。所以,關於第一個 STRIKE-PE,就像你評論的那樣,我的意思是,很明顯 STORM-PE 目前是亮點,但 STRIKE-PE 肯定證實了 CAVT 的長期益處。您可能還記得,那項研究持續了一年,並著眼於功能性結果。從長遠來看,這些患者一年後的狀況如何?因此,這只是為整體證據庫增添了新的證據。在 VIVA 會議上,專門介紹了 Flash 產品在這些患者中的應用以及長達一年的追蹤。

  • At TCT, there was a data set around the high-risk PE patients and just showing that CAVT can have a real benefit in that patient group. So overall, I think it's just a growing body of evidence in PE. And so I think the -- what you'll start to see is that these PER teams and PE teams across the board are just going to have more of a focus around treating more patients with CAVT.

    在 TCT,有一組關於高風險 PE 患者的數據,顯示 CAVT 可以對該患者群體產生真正的益處。所以總的來說,我認為這只是體育教育領域越來越多的證據。因此,我認為——你會開始看到的是,這些 PER 團隊和 PE 團隊將會更專注於治療更多患有 CAVT 的患者。

  • On your second question, as it relates to the embolization products and that category as a whole, the team now is in place to focus 100% on our embolization products. And while we are market leading, we do not yet have 100% of the market. So I think there is still opportunity to continue to grow that. Our physicians love the way the coils perform. And so the focus just allows our team to be able to go and make sure that the coils are available to everyone.

    關於你的第二個問題,即與栓塞產品及整個類別相關的問題,目前團隊已就位,將 100% 專注於我們的栓塞產品。雖然我們處於市場領先地位,但我們尚未佔據100%的市場份額。所以我認為這方面仍有繼續發展的機會。我們的醫生對這種線圈的性能非常滿意。因此,我們團隊的重點工作就是確保每個人都能獲得線圈。

  • On top of that, you see MMAs are sort of a newer procedure overall. And as Adam alluded to, there are some of the more traditional options like embolics that have been available, but the coils, the way they perform, our coil specifically have really been -- our physicians have been really been responding well to that. So I think you're seeing here a combination of what we have with the peripheral embolization focus as well as the growing number of procedures in the MMA category.

    此外,MMA手術整體來說也算是一種比較新的手術。正如亞當所暗示的那樣,還有一些更傳統的選擇,例如栓塞術,但是線圈,就其性能而言,特別是我們的線圈,確實——我們的醫生對它的反應非常好。所以我認為你在這裡看到的是外周栓塞治療的重點以及MMA類別手術數量的增長。

  • Operator

    Operator

  • And that concludes the question-and-answer portion of today's conference call. Ms. Furlong, I will turn the call back over to you.

    今天的電話會議問答環節到此結束。弗隆女士,我把電話轉回給您。

  • Cecilia Furlong - Director of Business Development

    Cecilia Furlong - Director of Business Development

  • Thank you, operator. On behalf of our management team, thank you all again for joining us today and for your interest in Penumbra. We look forward to updating you on our fourth quarter call.

    謝謝接線生。我謹代表管理團隊,再次感謝各位今天蒞臨指導,並感謝各位對Penumbra的關注。我們期待在第四季財報電話會議上向您報告最新情況。

  • Operator

    Operator

  • And ladies and gentlemen, this concludes today's call, and we thank you for your participation. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束,感謝各位的參與。您現在可以斷開連線了。