Penumbra Inc (PEN) 2024 Q3 法說會逐字稿

Hello. Good afternoon. My name is Jeremy, and I'll be your conference operator today. At this time, I would like to welcome everyone to Penumbra's third-quarter 2024 conference call. (Operator Instructions)

你好。午安.我叫傑瑞米，今天我將擔任你們的會議操作員。此時此刻，我歡迎大家參加 Penumbra 的 2024 年第三季電話會議。 （操作員說明）

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

我想介紹一下 Penumbra 業務開發和投資者關係部門的 Cecilia Furlong 女士。弗隆女士，您可以開始會議了。

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 2024. 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.

感謝營運商，感謝大家參加今天的電話會議，討論 Penumbra 2024 年第三季度的收益發布。的“投資者”選項卡下。

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, 2023, 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》的安全港條款做出前瞻性聲明，包括有關我們的財務表現、商業化、臨床試驗、監管狀況、品質、合規性的聲明，以及商業趨勢。由於某些風險和不確定性，包括我們向SEC 提交的截至2023 年12 月31 日的10-K 年度報告中提到的風險和不確定性，實際結果可能與我們的前瞻性陳述中明示或暗示的結果存在重大差異。

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 (technical difficulty) 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，並鼓勵您查看我們向 SEC 提交的定期文件，包括前面提到的 10-K，以便更全面地討論這些因素和其他風險這可能會影響我們未來的業績或我們股票的市場價格。 Penumbra 不承擔因新資訊、未來事件、發展或其他原因而更新或修改我們的前瞻性陳述的任何（技術困難）。

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.

在本次電話會議上，收入和毛利率的財務表現按照公認會計原則（GAAP）計算，而營運費用、營運收入和調整後的 EBITDA 則按照非公認會計原則（Non-GAAP）計算。我們發布的新聞稿中提供了相應的 GAAP 衡量標準以及 GAAP 與非 GAAP 財務衡量標準的調整表。

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, a one-time expense associated with the acquisition of IPR&D of $18.2 million in the third quarter of 2023, and amortization of acquired intangible assets of $2.4 million in the third quarter of 2023. Adjusted EBITDA of $56.7 million for the third quarter of 2024 excludes the 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，這是與 2024 年第三季收購 IPR&D 相關的一次性費用 1,820 萬美元。的無形資產攤提為240 萬美元。

Adam Elsesser, Penumbra's Chairman and CEO, will provide a business update. Maggie Yuen, our Chief Financial Officer, will then discuss our financial results for the third quarter of 2024, and Jason Mills, our Executive Vice President of Strategy, will discuss our 2024 guidance.

Penumbra 董事長兼執行長 Adam Elsesser 將提供業務最新動態。然後，我們的財務長 Maggie Yuen 將討論我們 2024 年第三季的財務業績，我們的策略執行副總裁 Jason Mills 將討論我們的 2024 年指引。

With that, I would like to turn the call over to Adam Elsesser.

說到這裡，我想將電話轉給 Adam Elsesser。

Thank you, Cecilia. Good afternoon. Thank you for joining Penumbra's third-quarter 2024 conference call. In the third quarter, we generated total revenue of $301 million, representing a year-over-year increase of 11.1% on a reported basis and 10.9% on a constant currency basis. Our third-quarter results reflect another strong performance by our US thrombectomy business, driven by continued adoption and further market penetration of our current CAVT portfolio, Lightning Flash 2.0 and Lightning Bolt 7.

謝謝你，塞西莉亞。午安.感謝您參加 Penumbra 2024 年第三季電話會議。第三季度，我們的總營收為 3.01 億美元，按報告計算年增 11.1%，以固定匯率計算年增 10.9%。我們的第三季業績反映出我們的美國血栓切除業務的強勁表現，這得益於我們目前的 CAVT 產品組合、Lightning Flash 2.0 和 Lightning Bolt 7 的持續採用和進一步的市場滲透。

US thrombectomy grew 21.2% year over year to $162.1 million, with our US VTE franchise delivering revenue growth of 32% year over year and 13% sequentially. The balance of our US thrombectomy franchise continued to perform very well in line with our expectations.

美國血栓切除術年增 21.2%，達到 1.621 億美元，我們的美國 VTE 特許經營業務收入年增 32%，環比增長 13%。我們美國血栓切除業務的平衡持續表現良好，符合我們的預期。

In the quarter, we received FDA clearance for two new CAVT products, Lightning Bolt 6x and Lightning Bolt 12, which further enhance and build out an increasingly comprehensive CAVT portfolio. I will provide additional details on these products later in my prepared remarks.

本季度，我們獲得了 FDA 批准兩款新的 CAVT 產品 Lightning Bolt 6x 和 Lightning Bolt 12，這進一步增強和建構了日益全面的 CAVT 產品組合。我將在稍後準備的發言中提供有關這些產品的更多詳細資訊。

In addition, we received CE Mark for Lightning Flash 2.0 and Lightning Bolt 7 in mid-September and are in the early phases of introducing our transformative technology to European markets. The trend of improving profitability continued in the third quarter, with gross margins expanding to 66.5%, up 90 basis points over the prior-year period,and non-GAAP operating income of $40.3 million or 13.4% of revenue in the third quarter, up 110 basis points year over year.

此外，我們在 9 月中旬獲得了 Lightning Flash 2.0 和 Lightning Bolt 7 的 CE 標誌，目前正處於將我們的變革性技術引入歐洲市場的早期階段。第三季獲利能力持續改善，毛利率擴大至 66.5%，較上年同期成長 90 個基點，非 GAAP 營業收入為 4,030 萬美元，佔第三季營收的 13.4%，較去年同期成長110個基點。

Behind positive product mix shift and operating efficiencies, we continue to see a path to a gross margin profile of over 70% within the next 18 to 24 months and expect non-GAAP operating margin expansion to outpace gross margin expansion for the foreseeable future. Additionally, backed by strong revenue growth, expanding gross margins and disciplined operating spend this quarter, we generated $51.3 million in operating cash before you include the impact of our $100 million stock buyback. We are well positioned to continue to increase our profitability and operating cash flow into the future.

在積極的產品組合轉變和營運效率的背後，我們繼續看到未來18 至24 個月內毛利率將達到70% 以上，並預計在可預見的未來，非GAAP 營運利潤率擴張將超過毛利率擴張。此外，在強勁的營收成長、不斷擴大的毛利率和嚴格的營運支出的支持下，本季我們產生了 5,130 萬美元的營運現金（不包括 1 億美元股票回購的影響）。我們處於有利位置，可以繼續提高未來的獲利能力和營運現金流。

Within our US peripheral business, the standout of the quarter, was Lightning Flash 2.0. Flash 2.0 consistently removes blood clots in VTE patients considerably faster than all older products. Given the speed of the procedure now with Flash 2.0, there is no significant blood loss.

在我們的美國外圍業務中，本季最出色的是 Lightning Flash 2.0。 Flash 2.0 始終能夠比所有舊產品更快清除 VTE 患者的血栓。考慮到目前使用 Flash 2.0 的手術速度，沒有明顯的失血。

This Flash 2.0 technology compares very favorably to other companies' older technology that takes much longer to remove blood clots with enough blood loss to make physicians feel like they need to return blood to the patients. As a result, Flash 2.0's performance continues to command physician interest, and our third-quarter results reflect strong adoption of our latest Flash technology in its first full quarter on the market, with September representing our highest month of VTE procedure volumes ever as we continue to gain VTE market share.

與其他公司的舊技術相比，這種 Flash 2.0 技術非常有利，後者需要更長的時間才能清除血塊，並且失血量足以讓醫生感覺他們需要將血液回輸給患者。因此，Flash 2.0 的表現繼續引起醫生的興趣，我們第三季度的業績反映出我們最新的Flash 技術在市場上第一個完整季度的大力採用，其中9 月份是我們有史以來VTE 手術量最高的月份。

The speed of Flash 2.0 was extremely evident in a PE case this quarter where a firefighter, who was 39 weeks pregnant was treated for a very serious PE with a Flash 2.0. The speed of the procedure saved the patient and her baby. I had the privilege of watching a video of her and her baby being greeted by a line of firefighters when she was being discharged from the hospital.

Flash 2.0 的速度在本季度的一起 PE 案例中表現得非常明顯，一名懷孕 39 週的消防員因非常嚴重的 PE 接受了 Flash 2.0 的治療。手術的速度拯救了病人和她的孩子。我有幸觀看了一段視頻，影片中她和她的孩子在她出院時受到一排消防員的歡迎。

In addition, we received FDA clearance for Lightning Bolt 12, expanding our portfolio of latest-generation CAVT products engineered to address VTE. Lightning Bolt 12 combines our proprietary modulated aspiration technology validated by Lightning Bolt 7's strong clinical outcomes with a catheter size designed to address smaller parts of the venous anatomy.

此外，我們也獲得了 FDA 對 Lightning Bolt 12 的批准，擴大了我們專為解決 VTE 問題而設計的最新一代 CAVT 產品組合。 Lightning Bolt 12 將經過 Lightning Bolt 7 強大臨床結果驗證的專有調製抽吸技術與專為解決靜脈解剖結構較小部分而設計的導管尺寸相結合。

The initial cases have gone very well. And this technology expands the number of VTE patients we can treat with our CAVT technology. While we expect modest initial contributions in the fourth quarter, looking to 2025 and beyond, we view CAVT's demonstrated value proposition and our increasingly comprehensive VTE-focused CAVT catheter portfolio, helping accelerate conversion from other mechanical thrombectomy products, lytics, and medical management.

最初的案件進展順利。這項技術擴大了我們可以使用 CAVT 技術治療的 VTE 患者的數量。雖然我們預計第四季度的初始貢獻不大，但展望2025 年及以後，我們認為CAVT 已證明的價值主張和我們日益全面的以VTE 為重點的CAVT 導管產品組合，有助於加速其他機械血栓切除產品、溶解劑和醫療管理的轉換。

Our US arterial business, led by Lightning Bolt 7, continued to perform well in the third quarter. FDA clearance of Lightning Bolt 6x in September further expands the reach of our advanced [CAV] technology to smaller arteries, including below-the-knee arterial occlusions, where our legacy catheters are currently used to treat a portion of the patient population. The introduction of Bolt 6x will deliver CAVT's benefits, improved procedure efficiency and a reduction in procedure times to these patients.

以Lightning Bolt 7為首的我們的美國幹線業務在第三季持續表現良好。 FDA 於 9 月批准 Lightning Bolt 6x，進一步將我們先進的 [CAV] 技術的應用範圍擴大到較小的動脈，包括膝下動脈閉塞，我們的傳統導管目前用於治療部分患者群體。 Bolt 6x 的推出將為這些患者帶來 CAVT 的優勢、提高手術效率並縮短手術時間。

Similar to Lightning Bolt 12, we expect modest contributions from 6x in the fourth quarter as we commence commercialization. That said, we see a meaningful opportunity for our arterial-focused CAVT portfolio, currently including Bolt 7 and Bolt 6x to accelerate physician conversion from open surgery or the use of lytics to a computer-assisted endovascular-first approach to treating arterial clot. Despite significant progress to date, we remain in the early stages of helping the over 800,000 patients annually in the US who suffer from VTE and arterial clot with our proprietary CAVT technology.

與 Lightning Bolt 12 類似，隨著我們開始商業化，我們預計第四季度 6x 的貢獻將不大。也就是說，我們看到了以動脈為中心的CAVT 產品組合（目前包括Bolt 7 和Bolt 6x）的一個有意義的機會，可以加速醫生從開放性手術或使用溶解劑轉向電腦輔助血管內優先治療動脈血栓的方法。儘管迄今為止取得了重大進展，但我們仍處於利用我們專有的 CAVT 技術幫助美國每年超過 80 萬名患有 VTE 和動脈血栓的患者的早期階段。

Turning to the neurovascular business, our team delivered another solid, double-digit performance in stroke thrombectomy. As interest wanes in the super large bore OE8 catheters as aspiration catheters, most of the companies with those products have switched to positioning them as guide catheters. This positions us very well with our market-leading aspiration portfolio, led by RED 72 with our proprietary SENDit technology and RED 43 as we prepare to bring Thunderbolt and the benefits of our CAVT technology to the neurovascular field.

轉向神經血管業務，我們的團隊在中風血栓切除術方面再次取得了兩位數的穩定表現。隨著人們對超大口徑 OE8 導管作為抽吸導管的興趣減弱，大多數擁有這些產品的公司已將其定位為引導導管。這使我們在市場領先的抽吸產品組合中處於有利地位，其中以採用我們專有的 SENDit 技術的 RED 72 和 RED 43 為主導，我們準備將 Thunderbolt 和 CAVT 技術的優勢引入神經血管領域。

As we previously announced, our THUNDER trial recently completed enrollment with follow-up scheduled to be completed by the end of the year. We will provide additional future updates as appropriate, but needless to say, we are excited about the prospect of bringing CAVT and its demonstrated clinical benefits and procedural advantages to the neurovascular field, further solidifying and enhancing our market-leading position in the field of stroke thrombectomy.

正如我們之前宣布的，我們的 THUNDER 試驗最近完成了註冊，後續計劃將於今年年底完成。我們將在適當的時候提供更多的未來更新，但不用說，我們對將CAVT 及其已證實的臨床益處和程序優勢引入神經血管領域的前景感到興奮，進一步鞏固和增強我們在中風領域的市場領先地位血栓切除術。

Shifting to our international business. In September, we received CE Mark for Lightning Flash 2.0 and Lightning Bolt 7, further expanding the global reach of our latest CAVT technology. Physician interest in the technology in European markets is high. And while we have commenced initial sales, we expect revenue contributions to scale in a measured fashion, given the current reimbursement landscape across the region. That said, over time, we see opportunity for CAVT in international markets, supported by the work we're currently doing in reimbursement and clinical evidence generation and backed by strong commercial execution.

轉向我們的國際業務。 9 月，我們的 Lightning Flash 2.0 和 Lightning Bolt 7 獲得了 CE 標誌，進一步擴大了我們最新 CAVT 技術的全球影響力。歐洲市場的醫生對該技術的興趣很高。雖然我們已經開始初始銷售，但考慮到該地區目前的報銷情況，我們預計收入貢獻將以適度的方式擴大。也就是說，隨著時間的推移，我們在國際市場上看到了CAVT 的機會，這得到了我們目前在報銷和臨床證據生成方面所做的工作的支持，並得到了強大的商業執行力的支持。

As we look towards 2025 and beyond, we view a significant opportunity for CAVT to globally transform the way blood clots are addressed and treated. Over the near term, we are focusing on executing a 4-pronged strategy that we previously laid out.

展望 2025 年及以後，我們認為 CAVT 面臨著在全球範圍內改變血栓解決和治療方式的重大機會。短期內，我們將重點放在執行先前製定的四管齊下的策略。

Number one, constant innovation to further enhance CAVT's comprehensive value proposition and further expand the patient population with clot burden able to be treated with CAVT therapy safely, effectively swiftly, and simply. Number two, clinical and health economic data generation via randomized clinical trials, real-world studies and our global -- and our market access initiatives to increase awareness, not only of CAVT's outcomes' benefits but also of the economic benefit to hospital systems.

第一，不斷創新，進一步增強 CAVT 的綜合價值主張，並進一步擴大能夠安全、有效、快速、簡單地接受 CAVT 治療的血栓負擔患者群體。第二，透過隨機臨床試驗、真實世界研究和我們的全球市場准入計畫產生臨床和健康經濟數據，以提高人們對 CAVT 結果益處和醫院系統經濟效益的認識。

Number three, investment in our commercial and market access teams to fully realize CAVT's potential and support sustainable strong growth in the number of patients able to benefit annually from a computer-assisted interventional approach. And number four, executing our strategy with a disciplined focus on driving operating efficiencies and an improving profitability profile.

第三，對我們的商業和市場准入團隊進行投資，以充分發揮 CAVT 的潛力，並支持每年能夠從電腦輔助介入方法中受益的患者數量持續強勁增長。第四，嚴格執行我們的策略，專注於提高營運效率和改善獲利狀況。

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

現在我將把電話轉給瑪吉，讓她檢查我們第三季的財務表現。

Thank you, Adam, and good afternoon, everyone.

謝謝亞當，大家下午好。

Today, I will discuss the financial results for the third quarter of 2024 financial results on this call for revenue and gross margin on a GAAP basis, while operating expenses and operating income on a non-GAAP basis, the corresponding GAAP measures are reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release.

今天，我將討論2024年第三季的財務業績，在此呼籲收入和毛利率按GAAP基礎，而營業費用和營業收入按非GAAP基礎，相應的GAAP措施是GAAP調節表我們發布的新聞稿中提供了非公認會計準則財務指標。

For the third quarter ended September 30, 2024, our total revenues were $301 million, an increase of 11.1% reported and 10.9% in constant currency compared to the third quarter of 2023. Our geographic mix of sales for the third quarter 2024 was 75.2% US and 24.8% international. Our US region reported growth of 16.2%, driven by 21.2% growth in our thrombectomy franchise.

截至2024 年9 月30 日的第三季度，我們的總營收為3.01 億美元，與2023 年第三季相比，報告成長11.1%，以固定匯率計算成長10.9%。銷售地理組合為75.2%美國及國際 24.8%。我們的美國地區報告成長了 16.2%，這主要得益於我們的血栓切除術業務成長 21.2%。

Our international regions decreased by 1.9% reported and 2.5% in constant currency, primarily due to a reduction in China revenue of $13.6 million, which was offset by an increase of $12.2 million in all other international regions. .

我們的國際地區收入下降了 1.9%，以固定匯率計算下降了 2.5%，這主要是由於中國收入減少 1,360 萬美元，但所有其他國際地區收入增加 1,220 萬美元所抵銷。 。

The sequential growth in our total revenues of 0.5% was primarily driven by an increase in our US thrombectomy revenue of $8.3 million, relatively flat revenue in Europe and offset by a decline in China revenue of $9.4 million.

我們總收入環比成長 0.5%，主要是由於美國血栓切除術收入增加 830 萬美元，歐洲收入相對持平，並被中國收入下降 940 萬美元所抵消。

Moving to revenue by products. Revenue from global thrombectomy business grew to $204.1 million in the third quarter of 2024, an increase of 14% reported and 13.8% in constant currency compared to the same period last year. Our US growth of 21.2% is driven primarily by continuous adoption of CAVT. Our international business declined by 7.1%, primarily driven by a decrease in China revenue, which was offset by an increase in all other international regions as compared to the same period last year.

轉向按產品劃分的收入。 2024 年第三季度，全球血栓切除業務收入成長至 2.041 億美元，與去年同期相比成長 14%，以固定匯率計算成長 13.8%。我們在美國實現 21.2% 的成長主要得益於 CAVT 的持續採用。我們的國際業務下降 ​​7.1%，主要是由於中國收入下降，但與去年同期相比，所有其他國際地區的收入成長抵消了這一下降。

Revenue from embolization and access business was $96.9 million in the third quarter of 2024, an increase of 5.5% reported and 5.2% in constant currency, which is in line with our expectations and primarily driven by an increase in the US. Gross margin for the third quarter of 2024 is 66.5% compared to 65.6% for the third quarter of 2023.

2024 年第三季栓塞和通路業務收入為 9,690 萬美元，報告成長 5.5%，以固定匯率計算成長 5.2%，這符合我們的預期，主要是由美國的成長推動的。 2024 年第三季的毛利率為 66.5%，而 2023 年第三季的毛利率為 65.6%。

We delivered 90 basis point improvements driven by favorable thrombectomy product mix across all regions and strong productivity improvements. Additionally, sequentially, we had a 100 basis point improvement in our gross margin, excluding the onetime $33 million immersive health care inventory write-off in the second quarter of 2024, which reflects higher thrombectomy product mix and favorable distributor mix. Our manufacturing team will focus on ramping up our volume, while driving our productivity and efficiency for our new product launches in the fourth quarter.

在所有地區有利的血栓切除產品組合和生產力的強勁提高的推動下，我們實現了 90 個基點的改進。此外，我們的毛利率連續提高了 100 個基點，不包括 2024 年第二季度一次性的 3300 萬美元沉浸式醫療保健庫存沖銷，這反映了更高的血栓切除產品組合和有利的分銷商組合。我們的製造團隊將專注於提高產量，同時提高第四季新產品發布的生產力和效率。

Now on to our non-GAAP operating expenses, non-GAAP operating income and margin and adjusted EBITDA. Total operating expense for the quarter was $160 million or 53.1% of revenue compared to $144.5 million or 53.3% of revenue for the same quarter last year. Research and development expenses for Q3 2024 were $22.6 million compared to $21 million for Q3 2023. SG&A expenses for Q3 2024 were $137.4 million or 45.6% of revenue compared to $123.5 million or 45.6% of revenue for the third quarter of 2023.

現在我們來看看我們的非公認會計準則營運費用、非公認會計準則營運收入和利潤率以及調整後的 EBITDA。本季總營運費用為 1.6 億美元，佔營收的 53.1%，去年同期為 1.445 億美元，佔營收的 53.3%。 2024 年第三季的研發費用為2,260 萬美元，而2023 年第三季為2,100 萬美元。季度的研究和開發費用為1.235 億美元，佔營收的45.6%。

We recorded operating income of $40.3 million or 13.4% of revenue in the third quarter of 2024, compared to an operating income of $33.2 million or 12.3% of revenue for the same period last year. We wound down out the immersive healthcare business in the later half of the quarter, resulting in GAAP operating expense savings of approximately $6 million.

2024 年第三季度，我們的營業收入為 4,030 萬美元，佔營收的 13.4%，而去年同期的營業收入為 3,320 萬美元，佔營收的 12.3%。我們在本季後半段結束了沉浸式醫療保健業務，導致 GAAP 營運費用節省約 600 萬美元。

We expect to create GAAP operating expense savings of approximately $40 million a year moving forward. With the full quarter of Immersive savings, we expect to continue our sequential margin expansion into Q4 2024.We posted adjusted EBITDA of $56.7 million or 18.8% of total revenue compared to $51.5 million or 19% in the third quarter last year.

我們預計未來每年將根據 GAAP 準則節省營運費用約 4,000 萬美元。憑藉Immersive 整個季度的節省，我們預計利潤率將繼續擴大到2024 年第四季。總收入的19%。

Turning to cash flow and balance sheet. We ended the third quarter with cash, cash equivalents and marketable security balance of $291 million and no debt, which is a decrease of $48.7 million sequentially due to the stock repurchase of $100 million during Q3 2024. Excluding the stock repurchase, our operating cash increased by $51.3 million driven by operation profitability and improvement in working capital management. We continue to expect positive operating cash flow trends for the rest of 2024 and beyond.

轉向現金流和資產負債表。截至第三季末，我們的現金、現金等價物和有價證券餘額為2.91 億美元，無債務，由於2024 年第三季回購了1 億美元的股票，環比減少了4,870 萬美元。回購，我們的營運現金增加由於營運獲利能力和營運資金管理的改善，增加了 5,130 萬美元。我們繼續預期 2024 年剩餘時間及以後將出現正面的營運現金流趨勢。

And now I'd like to turn the call over to Jason to discuss our guidance.

現在我想將電話轉給 Jason 來討論我們的指導。

Thank you, Maggie, and good afternoon, everyone.

謝謝瑪吉，大家下午好。

We reiterate our total revenue guidance range for 2024 of $1,180 million to $1,200 million. With one quarter remaining in the year, we are comfortable with expectations at the middle of this range, which is where they were coming into this call. Furthermore, we are raising the lower end of our 2024 guidance range for US thrombectomy growth to 24% to 25% from 23% to 25% previously. .

我們重申 2024 年總收入指引範圍為 11.8 億美元至 12 億美元。距離今年還剩一個季度，我們對這個範圍的中間預期感到滿意，這也是他們在這次電話會議中的預期。此外，我們將 2024 年美國血栓切除術成長指引範圍的下限從先前的 23% 至 25% 提高至 24% 至 25%。 。

Moving down the income statement. We expect gross margin in the fourth quarter to be consistent with third quarter levels, and we expect non-GAAP operating margin to expand sequentially. Excluding the impact from the Immersive Healthcare impairments, these metrics would correlate with our full year guidance of 100 basis points to 150 basis points improvement in gross margin and 100 basis points to 200 basis points improvement in operating margin.

將損益表向下移動。我們預計第四季度的毛利率將與第三季的水平一致，並且我們預計非公認會計原則營業利潤率將連續擴大。排除沉浸式醫療保健損傷的影響，這些指標將與我們的全年指導相關，即毛利率提高 100 個基點到 150 個基點，營業利潤率提高 100 個基點到 200 個基點。

Operator, we can now open the call for your questions.

接線員，我們現在可以打開電話詢問您的問題。

(Operator Instructions) Richard Newitter, Truist Securities.

（操作員指令）Richard Newitter，Truist 證券公司。

Hi, thanks for taking the question. Maybe just to start off on the US. Thrombectomy was a healthy 22%. I think you said that your US Venus or VTE was 32%. Maybe could you just go over the US Neuro thrombectomy piece, if I might calculation and it might be wrong, but I would suggest a pretty big deceleration in the third quarter. Is that right? And how should we think about the trend there and going forward?

您好，感謝您提出問題。也許只是從美國開始。血栓切除術的健康率為 22%。我想你說你的美國維納斯或VTE是32%。也許你可以看一下美國神經血栓切除術的文章，如果我可以計算的話，它可能是錯的，但我建議第三季出現相當大的減速。是這樣嗎？我們該如何思考那裡的趨勢以及未來的趨勢？

Yeah. Thanks for the question. I appreciated our from our fruit business had a really good sort of high double digit growth from. So I don't think I would qualify that as a deceleration.

是的。謝謝你的提問。我很高興我們的水果業務取得了非常好的兩位數成長。所以我認為我不會將其視為減速。

If you remember, the elements that go into US thrombectomy, we have a Neuro. We have arterial peripheral arterial coronary as well as VTE. And obviously, coronary, which has been out there with our legacy product for many years is in the single digits. So I think that's the delta. But Neuro did really well this quarter.

如果您還記得美國血栓切除術的要素，我們有 Neuro。我們有動脈、週邊動脈、冠狀動脈、靜脈血栓栓塞。顯然，多年來一直與我們的傳統產品一起出現的冠狀病毒的銷售只有個位數。所以我認為這就是三角洲。但 Neuro 本季表現非常好。

Okay. Sorry, that's my math. So I apologize that I congratulate the very solid US Neuro growth through. I guess maybe just on the international piece and your view of recovery for those regions and as we look forward into '25, and it seems like the international business continues to be somewhat unpredictable. So what's your visibility there?

好的。抱歉，這是我的數學。因此，我很抱歉，我祝賀美國神經系統的強勁發展。我想也許只是關於國際業務以及您對這些地區復甦的看法，當我們展望 25 世紀時，國際業務似乎仍然有些不可預測。那麼你在那裡的能見度如何？

And how do we think about new product contribution in some of the areas that are just launching in with the new products to offset that? Thank you.

我們如何看待新產品在一些剛推出的新產品領域的貢獻來抵銷這種影響？謝謝。

Yeah, I think it's a great question. I think, look, we've talked about trying to last quarter and sort of what's happening for us, particularly as we go from our licensing revenue model to the distribution model. That's part of our deal. We spent a lot of time last quarter walking through that. So really nothing has changed that that just now showing up. So we've sort of taken that into account.

是的，我認為這是一個很好的問題。我想，看，我們已經討論過上個季度的努力以及我們正在發生的事情，特別是當我們從許可收入模式轉向分銷模式時。這是我們協議的一部分。上個季度我們花了很多時間來解決這個問題。所以，實際上，剛剛出現的情況並沒有任何改變。所以我們已經考慮到了這一點。

There's no new information there. Obviously as China recovers. And that will be an upside in the future, whether that's the back half of 2025 or 2026 or beyond. There's certainly significantly fewer headwinds in 2025 and there were in 2024 internationally. And there's some real bright spots with, as we've called out on this call, the launch of a flash 2.0 as well as Lightning Bolt 7.

那裡沒有新資訊。顯然，隨著中國的復甦。無論是 2025 年下半年、2026 年或更晚的時間，這都將是未來的優點。 2025 年和 2024 年國際上的阻力肯定會明顯減少。正如我們在這次電話會議中所指出的，flash 2.0 和 Lightning Bolt 7 的推出確實帶來了一些真正的亮點。

Obviously, there's a lot of interest. There's a lot of conversations between physicians here in the states that are using it to their colleagues in European markets and on. I think as we roll that out, we're going to see that part of the business. I do really, really well. So there's not a lot of new, news on our international markets. This is playing out how we had talked about it for a while.

顯然，人們對此很感興趣。美國各州的醫生與歐洲市場及其他地區的同事進行了許多對話。我認為，當我們推出該產品時，我們將看到這部分業務。我做得真的非常好。因此，我們的國際市場上沒有太多新消息。這就是我們已經討論了一段時間的情況。

Robbie Marcus, JPMorgan.

羅比馬庫斯，摩根大通。

Thanks for taking the questions and congrats on a nice quarter here. Two for me, first wanted to ask on the margin expansion. Once again came in nice. We saw some upside there, especially on EPS.

感謝您提出問題，並祝賀您度過了一個愉快的季度。對我來說有兩個，首先想問的是關於利潤擴張的問題。再次進來很好。我們看到了一些好處，尤其是每股盈餘。

How should we think about your ability to continue to drive this margin expansion? Is it one of these things that 100 basis points to 200 basis points is a good range to use along? Is that thrombectomy continues to grow the elevated levels? Or is there something one-time in '24?

我們該如何看待您繼續推動利潤率擴張的能力？ 100 個基點到 200 個基點是一個很好的使用範圍嗎？血栓切除術是否繼續上升水平？或者說24年有什麼一次性的事情嗎？

Yeah. If you're talking about gross margin, we that is a longer term process that we've laid out for a while now, which is it's a combination of efficiencies and together with the product shift as we move toward a bit bigger chunk of that business coming from our CABT platform.

是的。如果你談論的是毛利率，那麼這是一個我們已經制定了一段時間的長期流程，它是效率和產品轉變的結合，因為我們朝著更大的目標邁進。

So that will continue for your time at operating margins again, that also we think will outpace the gross margin. And I think this is the quarter that is like some of the past quarters that has shown that we have a really profitable business here and we can do both things.

因此，您的營業利潤率將再次持續，我們也認為這將超過毛利率。我認為這個季度就像過去的一些季度一樣，表明我們在這裡擁有真正盈利的業務，而且我們可以做這兩件事。

We can obviously invest in this and we laid out again, sort of clearly the four pronged strategy where we can invest in innovation will invest in the clinical data in a variety of fashions as well as in the growth of our call, virtual and market access teams.

顯然，我們可以對此進行投資，我們再次明確了我們可以投資創新的四管齊下的策略，將以各種方式投資於臨床數據，以及我們的電話、虛擬和市場准入的成長團隊。

All of those folks investments focused on growth at the same time doing that in a very, very profitable business. So I think we're pretty clear in the prepared remarks about that. That hasn't changed from the past. It's just clearer than ever now. And I think this quarter puts a pretty fine point on that.

所有這些人的投資都集中在成長上，同時在一個非常非常有利可圖的業務中成長。所以我認為我們在準備好的評論中對此已經非常清楚了。這一點與過去相比並沒有改變。現在比以往任何時候都更清晰。我認為本季對此提出了很好的觀點。

I was thinking operating margin, so you got both of them. I appreciate that.

我考慮的是營業利潤率，所以你兩者都得到了。我很欣賞這一點。

Just be sure. I covered it all for you.

請確定。我已經為你講述了這一切。

I really appreciate it. And then on just came back from TCT today and we saw yesterday that Peerless data from your competitor.

我真的很感激。今天剛從 TCT 回來，我們昨天看到了你們競爭對手的 Peerless 數據。

And I guess the question is, do you think that's going to be viewed by the clinical community as specific to your competitor? Or do you think that's going to be applied to contact me and general and translate to your business as well?

我想問題是，您認為臨床界會認為這是針對您的競爭對手的嗎？或者您認為這將適用於與我和一般人員聯繫並轉化為您的業務嗎？

Yeah, look, without being inappropriate, given the pretty muted reaction that we've seen and heard from most physicians, we certainly hope that it's not viewed no for all compare for all products. Some obviously some of the details there. We're not surprising given the procedure, the duration of the procedure with their older devices and really the bleeding rates that aren't true now with flash 2.0.

是的，聽著，考慮到我們從大多數醫生那裡看到和聽到的相當平靜的反應，這並不是不恰當的，我們當然希望它不會被視為所有產品的所有比較。一些顯然有一些細節。考慮到該手術、舊設備的手術持續時間以及目前 Flash 2.0 所不具備的出血率，我們並不感到驚訝。

So, I think flash, CAVT and 2.0 are commanding a lot of attention. And I think from everyone we've talked to there on the ground as well as we were reading at. I think we're all looking past that particular type of study and to the more important comparison, which is against anti-coagulation.

所以，我認為flash、CAVT和2.0引起了很多關注。我認為來自我們在現場交談過以及我們閱讀過的每個人的意見。我認為我們都在忽略那種特定類型的研究，轉向更重要的比較，即與抗凝血治療的比較。

And unlike we're running in our STORM study, and I think that's where the real energy has put in the field, and that's where the interest is. So I guessed given those issues, we weren't surprised with somewhat of a muted reaction. But I don't think it's a negative for us at all.

與我們正在進行的 STORM 研究不同，我認為這就是該領域真正投入精力的地方，也是人們感興趣的地方。所以我猜考慮到這些問題，我們對反應平淡並不感到驚訝。但我認為這對我們來說根本不是負面的。

Larry Biegelsen, Wells Fargo.

拉里·比格爾森，富國銀行。

Hi, it's [Kelly] calling in for Larry. Thanks for taking my question. Just starting with the Thunder trial. Congratulations on completing the patient enrollment, we saw on clinicaltrials.gov that the sample size, the patient sample pie has changed. It's a little bit less than what you started with. And the endpoint has changed. One of the safety endpoints has changed. Can you just comment on those and if the FDA agreed to those changes? And I have a follow-up.

嗨，我是[凱莉]打來拉里的電話。感謝您提出我的問題。剛從雷霆審判開始。恭喜您完成患者入組，我們在 ClinicalTrials.gov 上看到樣本量、患者樣本餡餅已發生變化。它比你開始時要少一點。且終點已經改變。安全性終點之一已發生變化。您能否對這些做出評論以及 FDA 是否同意這些變更？我有一個後續行動。

Yes, the FDA did agree to those changes. That is accurate.

是的，FDA 確實同意這些改變。這是準確的。

I mean, you have for both of those changes.

我的意思是，這兩個改變你都有。

Yes.

是的。

Okay, perfect. Thank you. And then, Adam, you mentioned a few times before and again on this call that there are fewer headwinds in '25 versus '24. Can you just elaborate on which headwinds would go away in '25 versus '24? And what additional tailwinds that we can see in '25?

好的，完美。謝謝。然後，亞當，你之前在這次電話會議上多次提到，與 24 年相比，25 年的阻力要少一些。您能否詳細說明一下 25 年和 24 年哪些不利因素會消失？ 25 年我們還能看到哪些額外的有利因素？

Thank you. That's a good question.

謝謝。這是個好問題。

So some of the things we've talked about this year -- at the beginning of the year, we talked about getting sort of recalibrating selling some of our embolization products and our access products in certain markets internationally where the reimbursement had gone down to the point where it wasn't a viable business.

因此，我們今年討論的一些事情 - 在今年年初，我們討論了在國際某些市場上重新調整我們的一些栓塞產品和通路產品的銷售，這些市場的報銷已降至這不是一項可行的業務。

That's obviously one, a significant issue that will not be prevalent in 2025. We talked a bit about China over the last couple of calls and recalibrating that as we move to the next phase. And so -- and also, the delay, if you will, in getting CAVT in Europe. So those are sort of the big topics that we were dealing with internationally, and those really go away and for the most part in 2025.

這顯然是一個在 2025 年不會普遍存在的重大問題。所以——如果你願意的話，還有在歐洲獲得 CAVT 的延遲。因此，這些都是我們在國際上處理的重大話題，但這些話題實際上會在 2025 年大部分時間消失。

Some of the things that are looking positive, obviously, we've also talked about new product launches are coming. We have the sort of continued share gain with existing products like what we just saw pretty significant share shift just again in yet another quarter with Flash 2.0 so pretty consistent movement there. I think when you add those up, we're looking forward to 2025 as well.

顯然，一些看起來正面的事情，我們也談到了即將推出的新產品。我們現有產品的份額持續增長，就像我們剛剛在另一個季度看到 Flash 2.0 的份額發生了相當大的變化一樣，因此那裡的變化相當一致。我認為當你把這些加起來時，我們也期待 2025 年。

Joanne Wuensch, Citi.

喬安妮‧溫施，花旗銀行。

Thank you very much. I actually have two quick questions. up on front. Can you walk us through your steps to get to your 80% gross margin goals over the next 18 months. How much of that is coming from real or the renamed label for that or something else?

非常感謝。我實際上有兩個簡單的問題。在前面。您能否向我們介紹一下在未來 18 個月內實現 80% 毛利率目標的步驟？其中有多少來自真實的或更名的標籤或其他東西？

And then my second question has to do with underbulk, congratulations on that completion of the clinical trial and the filing. But I'm curious about the steps to commercialization and how you think about uptake?

然後我的第二個問題與小批量有關，祝賀臨床試驗和備案的完成。但我很好奇商業化的步驟以及您如何看待採用？

Yeah. Good questions. I maybe misheard you. I think you asked about gross margins. And I think you said getting them to 88% as opposed to what we had said out there, which was 70%. So I just want to make sure I heard it right. I might not have. But gross margins, we think, can get to above 70%.

是的。好問題。我可能聽錯你的話了。我想你問的是毛利率。我想你說的是讓他們達到 88%，而不是我們所說的 70%。所以我只是想確保我沒聽錯。我可能沒有。但我們認為毛利率可以達到70%以上。

And the big issue there is continued efficiencies, but the primary driver is just as we go further and deeper into CAVT products, the margins are different, and the product shift drives that. So that's the primary driver getting to the gross margin number that we talked about or above that.

最大的問題是持續的效率，但主要驅動力是隨著我們進一步深入 CAVT 產品，利潤率有所不同，而產品轉移推動了這一點。因此，這是達到我們所討論的或更高的毛利率數字的主要驅動因素。

On Thunderbolt, you talked about sort of the question was related to commercialization. Before we get ahead of ourselves, let do the follow-up for that to do -- we should complete that by the end of this year. And then obviously, we'll submit it and go through that. We certainly know how to launch products after 20 years, and we certainly are pretty excited about it. But let's wait until we can get the trial formally finished with the follow-up and move on, and then we'll give you more updated information at that point.

在 Thunderbolt 上，您談到了一些與商業化相關的問題。在我們超前之前，讓我們先做一下後續工作——我們應該在今年年底前完成。然後顯然，我們將提交它並進行處理。我們當然知道如何在 20 年後推出產品，我們對此感到非常興奮。不過，讓我們等到試驗正式結束並進行後續處理後，我們才會向您提供更多最新資訊。

Thank you. Sorry, if I set your goal is too high.

謝謝。抱歉，如果我給你的目標太高了。

Well, it's a good internal goals, and I'm just joking.

嗯，這是一個很好的內部目標，我只是在開玩笑。

Michael Sarcone, Jefferies.

邁克爾·薩爾科內，杰弗里斯。

Just first one for me. A really nice growth in USDTE. Could you maybe talk to us about where you think your share is shaking out of profitable each day?

對我來說只是第一個。 USDTE 的成長非常好。您能否與我們談談您認為您的股票每天在哪些方面失去獲利？

You know, I think it's probably premature. Maybe we'll sort of do it at the end of the year like we did last year to sort of do a recalibration. Obviously, quarter after quarter this year, we've seen a share shift toward us. But in terms of putting your exact numbers on it, I think it's premature. We'll consider doing that again as we the year. The PE part of it been pretty significant. We already were pretty successful in DVT sort of sharing that business 50-50. But we've seen a huge change in the PE shift -- and a lot of that really comes down to what I said.

你知道，我認為這可能還為時過早。也許我們會像去年一樣在年底進行重新校準。顯然，今年每個季度，我們都看到份額向我們轉移。但就給出確切的數字而言，我認為現在還為時過早。今年我們會考慮再次這樣做。 PE 部分非常重要。我們在 DVT 方面已經相當成功，以 50-50 的比例分享業務。但我們已經看到私募股權的轉變發生了巨大的變化——其中許多確實可以歸結為我所說的。

The product as 2.0 is so fast. The time of the procedure, dramatically different, no significant blood loss at all. Therefore, you don't have the same anxiety, the same worry of having so much blood loss that you have to put the blood back in using other products and so on to do that. And that's just -- by definition, if you can get all the clot out much faster and don't have any issue of need to put anything back in, that's better for the patient. It's able to stabilize patients much faster -- and frankly, I think it bodes really, really well for the future.

2.0的產品是如此之快。手術時間截然不同，沒有明顯失血。因此，您不會有同樣的焦慮，同樣擔心失血過多，以至於您必須使用其他產品來補充血液，等等。這就是——根據定義，如果你能更快地取出所有凝塊，並且不存在任何需要將任何東西放回去的問題，這對病人來說更好。它能夠更快地穩定患者的病情——坦白說，我認為這對未來來說是一個非常非常好的兆頭。

And again, it just goes to the need to constantly be innovating in these fields. Things change, products get better and better. And I hope all of us are excited about that and applaud that. That's sort of the point of innovation that we've been obviously known for the past 20 years.

再說一遍，這只是需要在這些領域不斷創新。事情發生了變化，產品變得越來越好。我希望我們所有人都對此感到興奮並鼓掌。這就是過去 20 年來我們眾所周知的創新點。

Got it. That's helpful, Adam. And just my follow-up, Bolt 6x and Bolt 12, just got FDA clearance. You have to go through that processes for each account to start selling those. Can you just talk about that process? And then maybe anything on pricing and what it does for economics on the P&L?

知道了。這很有幫助，亞當。我後續的產品 Bolt 6x 和 Bolt 12 剛剛獲得 FDA 批准。您必須為每個帳戶完成流程才能開始銷售這些帳戶。能簡單講一下這個過程嗎？然後也許還有關於定價的事情以及它對損益表的經濟學有何影響？

Yeah. Well, a couple of things just first on price. Obviously, the CAVT products have a little bit different price point than the non-CAVT products do. So there in a comparison to legacy products, which are literally just the catheter and the original pump, there is obviously going to be a difference. In terms of the process, yes, I am not aware of a blanket free pass and not having to go through the process with new products.

是的。嗯，首先是價格方面的一些事情。顯然，CAVT 產品的價格點與非 CAVT 產品略有不同。因此，與傳統產品（實際上只是導管和原始幫浦）相比，顯然會有差異。就流程而言，是的，我不知道一攬子免費通行證並且不必經歷新產品的流程。

These are obviously new products we'll go through that process. And again, having launched multiple products every year for many, many years now, I think we know how to do it, and we'll keep going. But they do have to go through the VAC process.

這些顯然是我們將經歷這個過程的新產品。再說一遍，多年來每年都會推出多種產品，我認為我們知道如何做到這一點，我們將繼續前進。但他們確實必須經過 VAC 流程。

Matthew O'Brien, Piper Sandler.

馬修·奧布萊恩，派珀·桑德勒。

Hi, this is Samantha on for Matt today and thanks for taking our question.

大家好，我是今天為馬特做的薩曼莎，感謝您提出我們的問題。

We want to ask more about the 6x and the new bolt 12 devices. And I guess specifically starting with the 6x. Can you talk just a little bit more about the difference between the below-the-knee catheter versus [APR 1] -- is it just the size of the catheter that's different? And then maybe talk about some of the competitive dynamics going on in the arterial market, too.

我們想詢問有關 6x 和新的 Bolt 12 設備的更多資訊。我想特別是從 6x 開始。您能否多談談膝下導管與 [APR 1] 之間的差異 - 只是導管的尺寸不同嗎？然後也許還可以談談動脈市場上正在發生的一些競爭動態。

Yeah. There's not -- on the size of the catheter, it's obviously a little smaller. The numbers [7 rends, 6 rends] can note that the smaller it is, the further distillate can go. So not just below the knee, but into smaller arteries in other parts of the body as well, which I mentioned in the prepared remarks. And that's just the natural evolution of CAVT as we bring it to other places.

是的。沒有——就導管的尺寸而言，它顯然要小一些。數字[7 rends, 6 rends]可以注意到，它越小，餾出物可以走得越遠。因此，不僅是膝蓋以下，還包括身體其他部位的小動脈，我在準備好的發言中提到了這一點。當我們將 CAVT 帶到其他地方時，這只是 CAVT 的自然演進。

The X part of the 6x is really a tool similar to what we call send it in the neuro space, where we help get the catheter and track it to more distal places. So it's really ease of tracking and so on. But overall, I think you've got the [gist] of the product. It just goes further into the vasculature, so we can remove that clot.

6x 的 X 部分實際上是一個類似於我們所說的將其發送到神經空間的工具，我們幫助獲取導管並將其追蹤到更遠端的位置。所以它真的很容易跟踪等等。但總的來說，我認為您已經了解了該產品的[要點]。它只是進一步進入脈管系統，因此我們可以移除該凝塊。

Your second question was what again, I apologize -- was it around 12 or not. What was the second part of that question.

你的第二個問題是，再次抱歉，是在 12 點左右嗎？該問題的第二部分是什麼？

Well, just competitive guide.

好吧，只是競爭指南。

In arterial. I'm sorry, I apologize. I think everyone knows there's not a lot of competition of ACT. There's a lot of companies with sort of gizmos and various things. I think we've seen this play out in stroke in the brain for years. This game sort of happened for many years in stroke. Aspiration works. Aspiration, the whole science behind aspiration is pretty clear, I think folks have understood that now in the neuro space.

在動脈。對不起，我道歉。我想大家都知道ACT的競爭並不激烈。有很多公司都有各種小玩意和各種各樣的東西。我想多年來我們已經在腦中風中看到了這種情況。這種遊戲在中風中已經發生了很多年。願望有效。願望，願望背後的整個科學非常清楚，我認為人們現在已經在神經領域中理解了這一點。

And I think that's working and people are starting to pretty clearly understand that in the arterial space on the vascular side. So there's not a lot of companies that are focusing on that. And certainly none of them have the modulated aspiration that we bring with Lightning Bolt 7 and Lightning Bolt 6x, which is really a whole total game changer, it sort of creates a new class, if you will, of technology.

我認為這是有效的，人們開始非常清楚地了解血管側動脈腔的情況。因此，並沒有很多公司關注這一點。當然，他們中沒有一個人擁有我們透過Lightning Bolt 7 和Lightning Bolt 6x 帶來的調製願望，這確實是一個徹底的遊戲規則改變者，如果你願意的話，它在某種程度上創造了一個新的技術類別。

So really, the fight for us, the competition, if you will, is open surgery and anti-coagulation and also analytic. All of that is where we put our energy, and that's where our focus has been, and that's what's really seen the continued growth of that business sort of quarter-over-quarter.

所以說真的，我們的鬥爭，如果你願意的話，競爭是開放性手術和抗凝血以及分析。所有這些都是我們投入精力的地方，也是我們一直在關注的地方，也是我們真正看到該業務逐季度持續成長的原因。

Great. Thank you. And then just one more quick one. I know we touched on the vendor trial a couple of times in the call from a different point. When would follow-up ending at the end of the year, when could we expect to see data for that trial?

偉大的。謝謝。然後再快一點。我知道我們在電話中從不同的角度多次談到了供應商試用。後續行動將於今年年底結束，我們什麼時候可以看到該試驗的數據？

I'm not going to -- so I made a mistake a few years back, obviously, in putting out times for a trial to end in all. So I'm not going to do that with a specific time. Obviously, as soon as we know that answer in a very specific way, we will let everyone know. Obviously, we're pretty excited to get that out there. But the specific time frame, we'll update when we have that -- when we have more information to finish the trial.

我不會——所以幾年前我顯然犯了一個錯誤，就是拖延了審判最終結束的時間。所以我不會在特定時間這樣做。顯然，一旦我們以非常具體的方式知道答案，我們就會讓所有人知道。顯然，我們非常高興能將其推出。但具體的時間範圍，當我們有更多資訊來完成試驗時，我們會更新。

Mathew Blackman, Stifel.

馬修布萊克曼，史蒂菲爾。

Great. I had a couple of stroke questions. Just curious for [Paul], can you give us the high the current sort of US stroke growth rate is sustainable until we get Thunderbolt. And then I'll just [lob] in the follow-up last week, Medtronic Philips announced the partnership any targeting stroke awareness. Just your thoughts on what impact, if any, that could have on the market over time. And it doesn't seem like it, but are there any competitive implications of a device provider teaming up with an imaging provider. Just be interested in hearing your thoughts on that?

偉大的。我有幾個關於中風的問題。只是對 [Paul] 感到好奇，您能否告訴我們，在我們獲得 Thunderbolt 之前，美國目前的中風成長率是可持續的。然後我將在上週的後續行動中[吊球]，美敦力飛利浦宣布了任何針對中風意識的合作關係。只是您對隨著時間的推移可能對市場產生什麼影響（如果有的話）的看法。看起來並非如此，但是設備提供者與成像供應商合作是否會產生競爭影響？只是有興趣聽聽您對此的想法嗎？

Yes. Well, let me answer that first, and then I'll go back to the sort of sustainability of our growth in stroke. I was thrilled to see that. The more folks are bringing awareness to the idea that we should be intervening on stroke patients. I mean this is something that 10-plus years ago now was shown definitively in many different randomized trials. So I think it's great. I don't think it has any device-specific impact. I mean I think we all know that the physicians are going to pick the product that works the best and get the cloud out fastest.

是的。好吧，讓我先回答這個問題，然後我將回到中風成長的可持續性問題。我很高興看到這一點。越來越多的人意識到我們應該對中風患者進行幹預。我的意思是，十多年前，許多不同的隨機試驗已經明確地證明了這一點。所以我認為這很棒。我不認為它有任何特定於設備的影響。我的意思是，我認為我們都知道醫生會選擇效果最好的產品並以最快的速度推出雲端。

And I don't think there's anything we should say other than applaud everybody, whether it's imaging companies, device companies, hospital systems in their local community to bring all kinds of awareness. We've been involved in lots of programs, bringing awareness to this, working with -- some of the big societies get ahead of stroke, as you know, over the years. And I applaud it, and I'm glad to see it, and I think it helps pay many, many patients. So I'm all in.

我認為除了為每個人鼓掌之外，我們沒有什麼可以說的，無論是成像公司、設備公司、當地社區的醫院系統，以提高人們的各種意識。如您所知，多年來，我們參與了許多項目，提高了人們對這一問題的認識，並與一些大型協會合作，以預防中風。我對此表示讚賞，我很高興看到它，我認為這有助於支付很多很多患者的費用。所以我全力以赴。

As it relates to or growth in the stroke business. I think we're in a really, really good spot. As I mentioned, on the call, there are a lot of companies with sort of the super board catheters that interest is clearly waning as people understand it and realize that maybe they are better focused as guide catheters, which is a very different thing than an aspiration catheter. And I think that's really laid the foundation for what I think will be a pretty good run on our business in stroke and a lot of excitement as we move toward bringing Thunderbolt to the Neuro space as well.

因為它與中風業務的成長有關。我認為我們處於一個非常非常好的位置。正如我在電話會議中提到的，有很多公司擁有某種超級板導管，隨著人們了解它並意識到也許他們更專注於引導導管，興趣明顯減弱，這與引導導管非常不同。 。我認為這確實為我們在中風方面的業務的良好運作奠定了基礎，隨著我們將 Thunderbolt 引入神經領域，我們也感到非常興奮。

Mike Kratky, Leerink.

麥克·克拉基，萊林克。

Hi, everyone. Thanks for taking your questions. On the arterial side, can you provide some more specifics on your US arterial thrombectomy growth during 3Q? And if the really strong momentum you've seen to date in that segment continued? And then just as a follow-up, was there anything specific to call out in 3Q in that segment that may have led to any deviation in the recent growth you've seen, if any?

大家好。感謝您提出問題。在動脈方面，您能否提供有關第三季度美國動脈血栓切除術增長情況的更多具體資訊？迄今為止，您在該領域看到的強勁勢頭是否持續？作為後續行動，第三季該細分市場是否有任何具體情況需要指出，可能導致您所看到的近期成長出現偏差（如果有的話）？

No. The Arteria business grew in the high teens of pretty challenging comps with -- from the prior year with the launch of Lightning Bolt 7. So we felt really, really good about the growth of the arterio business. The product works, I mean, it's just that simple. Lightning Bolt 7 really works, lightly Baltic really works. And it's getting the cloud out quickly easily.

不。我的意思是，該產品有效，就這麼簡單。 Lightning Bolt 7 確實有效，lightly Baltic 確實有效。而且它可以快速、輕鬆地消除雲端。

There's not a lot of issues there. So I think we're seeing that continue. And again, we just are doing the work between launching 2.0, continuing to launch the brand new products, continue to penetrate with 7. The guys in the field have their hands full talking about some of the most innovative products this field has ever seen. But that business is really, really solid right now.

那裡沒有太多問題。所以我認為我們會看到這種情況繼續下去。再說一次，我們只是在做 2.0 發布之間的工作，繼續推出全新產品，繼續滲透 7。但現在這項業務確實非常穩固。

Understood. Thanks for the color. Then maybe just one quick one. In terms of the BTK side of the world, do you think about that as more of a market expansion story? Or is that something that you think is probably going to be more of an increased utilization.

明白了。謝謝你的顏色。然後也許只是一個快速的。就 BTK 而言，您是否認為這更像是一個市場擴張故事？或者您認為這可能會增加利用率。

It really is just a catheter size question. Right now, if you go backwards to before we add CAVT we didn't really think about them as below the knee or not because the catheters, whatever size you could get to the clock is what you would use. But it became a little more like that when we had CAVT only on a catheter size that really doesn't go below the knee, which is the Bolt 7.

這其實只是一個導管尺寸問題。現在，如果你回到我們添加 CAVT 之前，我們並沒有真正考慮它們是否在膝蓋以下，因為導管，無論你能得到的尺寸是什麼，你都會使用。但當我們只對尺寸確實不低於膝蓋的導管（即 Bolt 7）進行 CAVT 時，情況就變得有點像了。

Now that we have it on a catheter that can go further down and below the knee, we're bringing that CAVT. Our goal is to bring the CAVT Technology to every part of the body that has a blood clot where CAVT can be helpful. And we're not fully done yet. And then continue innovating from there. So we're well underway on that plan.

現在我們已經將它安裝在可以進一步向下延伸到膝蓋以下的導管上，我們正​​在引入 CAVT。我們的目標是將 CAVT 技術引入身體每個有血栓的部位，使 CAVT 能夠發揮作用。我們還沒有完全完成。然後從那裡繼續創新。所以我們正在順利實施該計劃。

Again, in the 4-pronged strategy that I laid out pretty clearly, innovation is number one. Innovation has always been number one for Penumbra. And that's why we made sure it was crystal clear. We're going to continue to bring CAVT Technology to every part of the body that can benefit from getting the clot out so much faster and so much safer.

再次強調，在我明確闡述的四管齊下的策略中，創新是第一位的。對 Penumbra 來說，創新始終是第一位的。這就是為什麼我們確保它非常清晰。我們將繼續將 CAVT 技術引入身體的各個部位，以便更快、更安全地排出血栓。

Pito Chickering, Deutsche Bank.

皮托·奇克林，德意志銀行。

Hey guys. A quick one here in guidance. You're raising your US thrombectomy guidance to at above the street, but maintaining your overall revenue guidance. Are there any other changes the other segments of your guidance?

嘿夥計們。這裡有一個快速的指導。您將美國血栓切除術指導提高到高於市場水平，但維持整體收入指導。您的指導的其他部分還有其他變化嗎？

No, I don't think so.

不，我不這麼認為。

No. So in the fourth quarter, I laid out, we said comfortable at the midpoint, that would be reflective obviously, of at least the midpoint of that new range of 24% to 25%. As you model out the international thrombectomy business, we've already talked about the headwinds that we're seeing internationally, especially in China, and so that's reflective of that.

不。當您對國際血栓切除術業務進行建模時，我們已經討論了我們在國際上看到的逆風，尤其是在中國，因此這反映了這一點。

But at the midpoint of the guidance, obviously, the fourth quarter ends up being in and around 20% growth for US thrombectomy is what is implied at the midpoint of guidance. And the rest of the business, I think, the Street is modeling somewhat appropriately.

但顯然，在指導的中點，第四季度美國血栓切除術的成長率約為 20%，這就是指導中點所暗示的。我認為，華爾街的其餘業務的建模有些適當。

All right. Great. One more on margins. So I understand gross margins expanding as the positive mix offers those tailwinds. But if I look specifically at SG&A leverage, how should we be thinking about how you balance revenue growth with investments to afford that growth? How much leverage that you can drive over the next couple of years? It seems as though there can be a lot of SG&A leverage over the next 3 to 5 years. Is this like a 50-plus basis point margin pension per year on SG&A next couple of years?

好的。偉大的。邊緣還有一個。因此，我理解毛利率會隨著積極的組合提供這些順風而擴大。但如果我專門關注 SG&A 槓桿，我們應該如何考慮如何平衡收入成長與投資以承受這種成長？未來幾年你可以發揮多大的槓桿作用？看來未來 3 到 5 年可能會有大量的銷售、管理及行政費用槓桿。這是否類似於未來幾年每年 SG&A 50 多個基點的邊際退休金？

Yes, without giving you a specific number, I think we've been pretty clear that we can really kind of do both. We can invest pretty significantly in the things that matter. And again, those really go back to the four pronged strategy, which is continued innovation, the data that will be relevant to continue to grow the thrombectomy business as well as the commercial team and the market access team that will drive really market growth going forward, and do that by continuing to run a pretty significantly profitable business. And I think this quarter shows that, and we're going to continue to do that going forward.

是的，在沒有給你具體數字的情況下，我認為我們已經非常清楚我們確實可以做到這兩點。我們可以在重要的事情上進行大量投資。再說一遍，這些實際上可以追溯到四管齊下的策略，即持續創新、與繼續發展血栓切除術業務相關的數據以及將真正推動市場未來成長的商業團隊和市場准入團隊，並透過繼續經營利潤相當可觀的業務來做到這一點。我認為本季度表明了這一點，我們將繼續這樣做。

Margaret Kaczor Andrew, William Blair.

瑪格麗特·卡佐爾·安德魯，威廉·布萊爾。

Everyone at McCauley on for Margaret tonight. Thanks for taking our question. And there's been a lot of discussion around changing the guidelines, obviously on the data at TCT this week, and I understand those product-specific.

今晚麥考利的每個人都為瑪格麗特服務。感謝您提出我們的問題。關於更改指南有很多討論，顯然是關於本週 TCT 的數據，我了解這些特定於產品的內容。

But as we look towards the longer-term adoption of thrombectomy and CAVT in particular, I guess, how do you think about guideline-changing recommendations? And ultimately, how does that tie into the market access work that you've been continuing to work on in the background?

但當我們展望血栓切除術和 CAVT 的長期採用時，我想，您如何看待改變指南的建議？最終，這與您一直在後台持續進行的市場准入工作有何關聯？

Yeah. I think it really depends on the vascular bed you're talking about. You're focusing on PE obviously, we're talking about PE a lot, and I'll address that in a second, but there's also DVT which is obviously, as I think you know, the larger number of patients as well as arterial, which are also a larger number of patients than PE.

是的。我認為這實際上取決於你所說的血管床。顯然，您關注的是 PE，我們經常談論 PE，我將立即解決這個問題，但還有 DVT，顯然，正如我認為您知道的那樣，患者數量較多，以及動脈瘤，其患者數量也比PE多。

So the guideline issues are really most acute right now around PE. And I think legitimately, if you just think about the numbers, 85% of patients in the pool of PE patients still are getting anti-coagulation. 10% or so are getting mechanical thrombectomy and the balance, I think, 5%, if my numbers add up are getting catheter-directed lysis.

因此，目前 PE 的指導方針問題確實是最尖銳的。我認為，如果你只考慮數字，PE 患者中 85% 的患者仍在接受抗凝血治療，這是合理的。大約 10% 的人正在接受機械血栓切除術，如果我的數字加起來的話，我想剩下的 5% 正在接受導管引導的溶解術。

So you're not -- the guideline change around the 2%, 3%, 4%, 5% isn't really relevant and it would be somewhat not particularly relevant for guidelines to change around a specific product, particularly given the reaction to the -- for most physicians to that data. I think really the field is looking to the trials that come out with anti-coagulation endpoints. And then I think guidelines will likely change.

所以你不是——圍繞 2%、3%、4%、5% 的指導方針變化並不真正相關，而且對於圍繞特定產品進行變化的指導方針來說也不是特別相關，特別是考慮到對大多數醫生來說，這些數據。我認為該領域確實正在尋找抗凝血終點的試驗。然後我認為指導方針可能會改變。

I think it's unlikely that it will be product specific, even if we're the product, that really stops innovation, and no one wants to stop innovation. What you want to do is prove the concept and move on and continue to innovate and get better and better. And I think back to 10-plus years ago, when the stroke trials came out, there was no real desire to stop innovation. So it was interventional means what people are using today versus what they used 10 years ago in stroke are dramatically different but the point still holds. So I think that's how I would look at the field going forward.

我認為，即使我們是產品，也不太可能真正阻止創新，而且沒有人願意阻止創新。你要做的就是證明這個概念，然後繼續前進，不斷創新，變得越來越好。我回想起十多年前，當中風試驗出現時，並沒有真正的願望停止創新。因此，介入意味著人們現在使用的治療方法與 10 年前治療中風的方法有很大不同，但這一點仍然成立。所以我認為這就是我對這個領域未來的看法。

That's great. And then just as a follow-up, I acknowledge the larger driver is the CAVT platform itself. But we've also heard quite a bit of positive receptivity of the Select plus launch this week. So has that been able to drive any incremental growth similar to when (inaudible) first launched as kind of a comparator?

那太棒了。作為後續行動，我承認更大的驅動力是 CAVT 平臺本身。但我們也聽到了人們對本週推出的 Select plus 的正面反應。那麼，這是否能夠推動任何增量成長，類似於（聽不清楚）首次作為比較器推出時？

Well, yes, thank you for raising it. We don't typically talk about the inner catheters like Select Plus, they're sort of -- there to just make the case faster and easier. People really, really like Select Plus, and it definitely has caught a lot of people's attention and made the cases even faster in terms of the access of the case.

嗯，是的，謝謝你提出來。我們通常不會談論像 Select Plus 這樣的內導管，它們只是讓案件變得更快更容易。人們真的非常喜歡 Select Plus，它確實吸引了許多人的注意，並且使案件的訪問速度更快。

So it's really inside the umbrella of Flash 2.0. If you're just making Flash 2.0 from start to finish, that much faster, getting it there faster, getting a cloud out now extremely fast. All of that adds up to an impression that this was really, really a great case. And I think that's going to continue to be what people gravitate to for quite a while.

所以它確實屬於 Flash 2.0 的範疇。如果您只是從頭到尾製作 Flash 2.0，那就快得多，更快地實現它，現在就可以非常快地推出雲端。所有這些都給人一種印象：這真的是一個非常非常好的案例。我認為這將在相當長一段時間內繼續成為人們所青睞的。

Chris Pasquale, Nephron Research.

克里斯·帕斯誇萊，腎臟單位研究。

Adam, I wanted to follow up on the question about both 12 and 6x. So buses what percentage of venous and arterial clots occur in vessels that are too small for flash or bolt 7 to reach? And are you guys involved in those cases today with non-CAT products? Or do those patients need to get treated with something else or with surgery?

Adam，我想跟進有關 12 和 6x 的問題。那麼，在閃光或螺栓 7 無法到達的血管中發生靜脈和動脈血栓的百分比是多少？你們今天是否參與過那些使用非 CAT 產品的案例？或是這些患者是否需要接受其他治療或手術治療？

Yes, it's a good question. I don't have really good numbers. So I don't want to just sort of throw out sort of more guesstimates on the percentages within sort of -- if you take 12, the venous space. And some of it's preference as well. People would like a smaller catheter in a certain case and so on. But the answer to the -- I think the more significant question is, are we in those cases today? Most of the time, if they are using mechanical, we're in those cases.

是的，這是一個好問題。我沒有很好的數字。所以我不想只是對靜脈空間內的百分比進行更多的猜測——如果你取 12，即靜脈空間。還有一些偏好。在某些情況下，人們會想要更小的導管等等。但我認為更重要的問題的答案是，我們今天是否處於這種情況？大多數時候，如果他們使用機械，我們就會遇到這種情況。

They're just using the non-CAVT to the extent that they need the smaller-sized product. And so that gives us an opportunity to move and bring the CAVT products to those vascular beds. And most of the time, those physicians have already experienced them in -- with our larger systems, both on the arterial and venous side. So they're all excited about getting the benefit of CAVT in those smaller vascular beds. So I think it's a pretty straightforward understanding of it. And I think it will just again, make -- it will provide the benefit to those patients in the smaller vascular beds with CAVT.

他們只是在需要較小尺寸產品的情況下使用非 CAVT。因此，這為我們提供了將 CAVT 產品轉移到這些血管床的機會。大多數時候，這些醫生已經在我們更大的系統中經歷過這些，無論是在動脈或靜脈方面。因此，他們都對在較小的血管床中受益於 CAVT 感到興奮。所以我認為這是一個非常簡單的理解。我認為它會再次為那些接受 CAVT 的較小血管床的患者帶來好處。

That's helpful. Thanks. And then you mentioned that reimbursement constraints in Europe could lead to a more measured uptake of flash and bold. Do you see any opportunities to push for incremental reimbursement maybe through some additional in-country clinical studies or things of that nature?

這很有幫助。謝謝。然後你提到，歐洲的報銷限制可能會導致人們更加謹慎地採用「閃光」和「大膽」。您是否認為有機會透過一些額外的國內臨床研究或類似性質的事情來推動增量報銷？

Yes. So I want to just maybe clarify the word you used. We don't really have reimbursement concerns. We just want to make sure we get an appropriate reimbursement for these products. Obviously, they come with more cost. When you're adding a computer to every chip, it's not like a catheter or syringe or something. It's a much different type of product.

是的。所以我想澄清一下你所用的字。我們確實不存在報銷問題。我們只是想確保我們獲得這些產品的適當補償。顯然，它們的成本更高。當你為每個晶片添加一台電腦時，它就不再像導管或註射器之類的東西了。這是一種非常不同類型的產品。

So by definition, that requires sort of more work to get that reimbursement and to prove that. And so yes, there are going to be opportunities to do that. in different forms, including with data, for sure. And we sort of -- I sort of mentioned that again, if you go back to the 4-pronged strategy in addition to that innovation is the generation of data that will continue to drive the growth of this. So it sort of fits into that bucket.

因此，根據定義，這需要更多的工作來獲得補償並證明這一點。所以，是的，將有機會做到這一點。當然，以不同的形式，包括數據。我再次提到，如果你回到四管齊下的策略，除了創新之外，數據的產生將繼續推動這一成長。所以它有點適合這個桶子。

Mike Matson, Needham.

麥克馬森，李約瑟。

Just a couple on Thunderbolt. So on the Thunder trial, do you think we'll see the data at some point maybe in the first half of next year before you submit it to the FDA? And then just pricing on Thunderbolt, I know you're not going to tell us what it is, but is it going to be at a similar sort of premium to what we've seen with what the venous side?

Thunderbolt 上只有一對。那麼，在 Thunder 試驗中，您認為我們會在明年上半年的某個時間點看到數據，然後再提交給 FDA 嗎？然後只是 Thunderbolt 的定價，我知道您不會告訴我們它是什麼，但它的溢價是否會與我們在靜脈側看到的類似？

Yeah, those are good questions. Well, we haven't even begun to sort of think about the exact timing of when the data would be published and presented. Usually, you do that around one of the significant Neuro meetings. But we haven't -- let's get the trial done first, and then we can give you updates on the specific timing. And I hope you appreciate that. But again, I'm excited about getting through that and getting it done.

是的，這些都是好問題。好吧，我們甚至還沒有開始考慮數據發布和呈現的確切時間。通常，您會在一次重要的神經會議期間進行此操作。但我們還沒有——讓我們先完成試驗，然後我們可以向您提供具體時間的最新資訊。我希望你能欣賞這一點。但再次，我很高興能夠完成並完成它。

In terms of price, sort of within the confines of the reimbursement structure of Neuro will obviously price this to be a profitable procedure for the hospitals. But yes, there likely will be a premium. I can't tell you that it would be dollar-for-dollar matched to a particular other CAVT product, they're all a little different based on the reimbursement structure of those vascular beds.

就價格而言，在 Neuro 報銷結構的範圍內，顯然這對醫院來說是一個有利可圖的手術。但是，是的，可能會有溢價。我不能告訴您，它會與特定的其他 CAVT 產品進行一美元對一美元的匹配，根據這些血管床的報銷結構，它們都略有不同。

There are no further questions at this time. Mr. Furlong, I turn the call back over to you.

目前沒有其他問題。弗隆先生，我把電話轉給你。

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

謝謝你，接線生。代表我們的管理團隊。再次感謝大家今天加入我們以及對 Penumbra 的興趣，並期待在我們的第四季電話會議上向您通報最新情況。

This concludes today's call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。