Penumbra Inc (PEN) 2022 Q4 法說會逐字稿

Good afternoon. My name is Kathy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Penumbra Fourth Quarter and Year-End 2022 Conference Call. (Operator Instructions)

下午好。我叫凱西，今天我將擔任你們的會議接線員。此時，我想歡迎大家參加 Penumbra 第四季度和 2022 年年終電話會議。 （操作員說明）

I would now like to introduce Ms. Jee Hamlyn-Harris, Investor Relations for Penumbra. Ms. Hamlyn-Harris, you may begin your conference.

我現在想介紹一下 Penumbra 投資者關係部的 Jee Hamlyn-Harris 女士。 Hamlyn-Harris 女士，您可以開始您的會議了。

Thank you, operator, and thank you all for joining us on today's call to discuss Penumbra's earnings release for the fourth quarter and full year 2022. A copy of the press release and financial tables, which include the GAAP to non-GAAP reconciliation, can be viewed under the Investors tab on our company website at www.penumbrainc.com.

謝謝接線員，也感謝大家參加今天的電話會議，討論 Penumbra 第四季度和 2022 年全年的收益發布。新聞稿和財務表格的副本，其中包括 GAAP 與非 GAAP 對賬，可以在我們公司網站 www.penumbrainc.com 的“投資者”選項卡下查看。

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, 2022, which is scheduled to be filed with the SEC on February 23, 2023.

在本次電話會議期間，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陳述，包括有關我們的財務業績、商業化、臨床試驗、監管狀況、質量、合規性的陳述和商業趨勢。由於某些風險和不確定性，包括我們截至 2022 年 12 月 31 日止年度的 10-K 中引用的那些，計劃於2023 年 2 月 23 日。

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，我們告誡您不要過分依賴這些前瞻性陳述，我們鼓勵您查看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，以便更全面地討論這些因素和其他風險可能會影響我們未來的業績或我們股票的市場價格。 Penumbra 不承擔因新信息、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義務。

On this call, certain financial measures 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.

在這次電話會議上，某些財務措施是在非 GAAP 基礎上提出的。我們發布的新聞稿中提供了相應的 GAAP 措施以及 GAAP 與非 GAAP 財務措施的調節。

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 fourth quarter and full year 2022; and Jason Mills, our Executive Vice President of Strategy, will discuss our 2023 guidance. Sandra Lesenfants, our President of Interventional, will join the team for questions.

Penumbra 董事長兼首席執行官 Adam Elsesser 將提供業務更新；我們的首席財務官 Maggie Yuen 隨後將討論我們 2022 年第四季度和全年的財務業績；我們的戰略執行副總裁 Jason Mills 將討論我們的 2023 年指導方針。我們的介入總裁 Sandra Lesenfants 將加入團隊提問。

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

有了這個，我想把電話轉給 Adam Elsesser。

Thank you, Jee. Good afternoon. Thank you for joining Penumbra's fourth quarter and year-end 2022 conference call. Our total revenues for the fourth quarter were $221.2 million, a year-over-year increase of 8.4% as reported and 10.5% on a constant currency basis. Our fourth quarter revenue increased 3.5% sequentially, our fastest sequential growth of the year and a trend we expect to continue into 2023. Our gross margin increased 110 basis points compared to the fourth quarter of 2021 and was consistent with our near-term expectations. We saw continued improvement in productivity, which was offset in the near term by inflationary pressures.

謝謝你，吉。下午好。感謝您加入 Penumbra 的第四季度和 2022 年底電話會議。我們第四季度的總收入為 2.212 億美元，同比增長 8.4%，按固定匯率計算增長 10.5%。我們第四季度的收入環比增長 3.5%，這是我們今年最快的環比增長，我們預計這一趨勢將持續到 2023 年。與 2021 年第四季度相比，我們的毛利率增長了 110 個基點，與我們的近期預期一致。我們看到生產率持續提高，但在短期內被通脹壓力所抵消。

We increased our non-GAAP operating income to $7.2 million, representing 3.3% of revenue in the fourth quarter, increasing nearly threefold year-over-year. We generated positive operating cash flow in the fourth quarter and continue to expect increasing profitability and operating cash flow in 2023, as I will discuss in a few minutes.

我們將非 GAAP 營業收入增加到 720 萬美元，佔第四季度收入的 3.3%，同比增長近三倍。我們在第四季度產生了正的運營現金流，並繼續預計 2023 年盈利能力和運營現金流將增加，我將在幾分鐘後討論。

For the full year 2022, our total annual revenues were $847.1 million, representing growth of 13.3% over full year 2021 on a reported basis. On a constant currency basis, total revenue grew 15.5% over 2021, which met our original guidance given this time a year ago.

2022 年全年，我們的年總收入為 8.471 億美元，按報告數據顯示比 2021 年全年增長 13.3%。按固定匯率計算，總收入比 2021 年增長 15.5%，符合我們一年前這個時候給出的最初指導。

We are now embarking on a new era in thrombectomy, and our team is focused on doing the purposeful work necessary to help the significant number of patients who can benefit from our proprietary computer-orchestrated thrombectomy products. Our journey to develop the most optimal solution for safe, effective, fast and powerful removal of blood clot, wherever it resides in the body, is nearly two decades in the making. And the early results from the use of Lightning Flash in venous and PE patients and Thunderbolt in our stroke trial is giving us even more confidence that the computer-orchestrated aspiration is changing the treatment paradigm in profoundly positive ways for patients and physicians.

我們現在正在開啟血栓切除術的新時代，我們的團隊專注於開展有目的的必要工作，以幫助大量患者受益於我們專有的計算機編排血栓切除術產品。我們開發最佳解決方案以安全、有效、快速和強大地清除血塊的旅程，無論它位於身體的任何地方，已經進行了將近二十年。在靜脈和 PE 患者中使用 Lightning Flash 以及在我們的中風試驗中使用 Thunderbolt 的早期結果讓我們更有信心，計算機控制的抽吸正在以對患者和醫生非常積極的方式改變治療模式。

Looking into 2023, we reiterate our expectations for our business. We expect to achieve at least $1 billion in total revenue, expand our gross margins, making progress toward our objective of 70% plus margins within a couple of years and increase our profitability and operating cash flow. We will realize these goals by helping more patients with our proprietary products.

展望 2023 年，我們重申對業務的期望。我們預計將實現至少 10 億美元的總收入，擴大我們的毛利率，在幾年內朝著我們 70% 以上利潤率的目標取得進展，並提高我們的盈利能力和經營現金流。我們將通過使用我們的專有產品幫助更多患者來實現這些目標。

And if we look beyond 2023, we believe we are still closer to the beginning of our journey to help all patients who have blood clot in their body rather than the end of the journey. There are over 1.25 million patients with clinically significant clot in their bodies in the United States alone across the five vascular beds we target. And the number of patients around the world with similar needs is 2 to 3x larger. The rate of treatment with mechanical thrombectomy in the United States ranges from under 10% to about 25%. So we have in front of us, in 2023 and beyond, a significant opportunity to help the vast majority of these patients with our computer-orchestrated thrombectomy.

如果我們展望 2023 年以後，我們相信我們仍然更接近幫助所有體內有血栓患者的旅程的開始，而不是旅程的結束。在我們所針對的五個血管床中，僅在美國就有超過 125 萬患者體內有臨床意義的血栓。世界各地具有類似需求的患者數量要多出 2 到 3 倍。在美國，機械血栓切除術的治療率從不到 10% 到大約 25% 不等。因此，在 2023 年及以後，我們面臨著一個重要的機會，可以幫助絕大多數這些患者進行我們的計算機編排血栓切除術。

During the fourth quarter of 2022, our Vascular business achieved record revenue of $129.7 million, accelerating sequentially to over 5% growth compared to the third quarter. Our Vascular business was driven by growth in our thrombectomy franchise, which grew over 20% year-over-year and also accelerated sequentially, growing 5%. We continued to gain share in the fourth quarter in venous, arterial and coronary with our Lightning 12, Lightning 7 and CAT RX products.

2022 年第四季度，我們的血管業務實現了創紀錄的 1.297 億美元收入，與第三季度相比連續加速增長超過 5%。我們的血管業務受到血栓切除術特許經營權增長的推動，該特許經營權同比增長超過 20%，而且環比增長 5%。我們在第四季度繼續通過我們的 Lightning 12、Lightning 7 和 CAT RX 產品在靜脈、動脈和冠狀動脈中獲得份額。

Looking into the first quarter, our Vascular team is launching full speed into the Lightning Flash era in the United States. Lightning Flash is performing just as we had expected and is being used successfully in both pulmonary embolism and DVT procedures. We are also proud to announce that we are embarking on a new era in arterial thrombectomy. Last week, LIGHTNING BOLT was cleared by the FDA. We have talked in the past about both the promise and the propriety of our modulating aspiration algorithms, which are built into both LIGHTNING BOLT and our Thunderbolt stroke product. We are excited about the potential of this technology for arterial patients. Initial evaluation cases using LIGHTNING BOLT are planned for the next few weeks, and we are on track to initiate a full launch of this product just before the end of March.

展望第一季度，我們的Vascular團隊正全速向美國的Lightning Flash時代進發。 Lightning Flash 的表現正如我們預期的那樣，並成功地用於肺栓塞和 DVT 手術。我們也很自豪地宣布，我們正在開啟動脈血栓切除術的新紀元。上週，LIGHTNING BOLT 獲得 FDA 批准。我們過去曾討論過我們的調製吸入算法的承諾和適當性，這些算法內置於 LIGHTNING BOLT 和我們的 Thunderbolt 中風產品中。我們對這項技術對動脈患者的潛力感到興奮。使用 LIGHTNING BOLT 的初始評估案例計劃在接下來的幾週內進行，我們有望在 3 月底之前啟動該產品的全面發布。

Moving to Thunderbolt. We are seeing solid progress in enrolling patients in our Thunder trial, and importantly, the product continues to perform just as we had anticipated. Notwithstanding the slowing in the growth of the stroke market that has been discussed during the past year, the RED catheters, which will be part of the Thunderbolt system and our other neuro products, continue to gain share in the United States and globally, which led to another quarter of sequential growth.

移動到 Thunderbolt。我們在 Thunder 試驗中招募患者方面取得了堅實的進展，重要的是，該產品繼續按照我們的預期運行。儘管在過去一年中討論的中風市場增長放緩，但將成為 Thunderbolt 系統和我們其他神經產品一部分的 RED 導管繼續在美國和全球獲得份額，這導致到另一個季度的連續增長。

The recent launch of RED 43, coupled with the launch of an access product, should help us grow our neurovascular business in 2023, leading up to the introduction of Thunderbolt. We continue to believe Thunderbolt has the potential to fundamentally change interventional treatment of ischemic stroke, and we believe this product in conjunction with the work of our extraordinary commercial team and partnership with physicians could create an environment in the stroke care system in the U.S. in which many more patients who suffer an ischemic stroke will get treated successfully and quickly.

最近推出的 RED 43，加上接入產品的推出，應該有助於我們在 2023 年發展我們的神經血管業務，從而促成 Thunderbolt 的推出。我們仍然相信 Thunderbolt 有可能從根本上改變缺血性中風的介入治療，我們相信該產品與我們非凡的商業團隊的工作以及與醫生的合作可以在美國的中風護理系統中創造一個環境，其中更多患有缺血性中風的患者將得到成功和快速的治療。

In sum, we still have a long way to go to reach all of these patients, and we believe Thunderbolt will help the field get there just as we expect our proprietary computer-orchestrated products to do across all five vascular beds. And while we think these products will initially have the biggest impact on our thrombectomy business in the United States, we plan to bring these products to physicians and patients in Europe, China, Japan, Asia Pacific and Latin America, where our businesses are already strong and growing, but still just as nascent in the U.S. relative to the number of patients we can ultimately help.

總之，要覆蓋所有這些患者，我們還有很長的路要走，我們相信 Thunderbolt 將幫助該領域實現這一目標，正如我們期望我們專有的計算機編排產品在所有五個血管床上發揮作用一樣。雖然我們認為這些產品最初將對我們在美國的血栓切除術業務產生最大影響，但我們計劃將這些產品帶給歐洲、中國、日本、亞太地區和拉丁美洲的醫生和患者，我們的業務在這些地方已經很強大並且不斷增長，但相對於我們最終可以幫助的患者數量而言，在美國仍處於起步階段。

Let me briefly discuss our Immersive Healthcare business before handing the call to Maggie. As we have stated in the past, we have restructured our work in this field to better fit with the current market. This has allowed us to focus on the two most important aspects of Immersive Healthcare. First, ensuring that patients who are using the real Immersive system are responding positively to the technology. And second, that we are working with large health care providers, both public and private, to figure out how to properly introduce our real Immersive system into the therapeutic workflow for patients who need rehabilitation as well as patients struggling with aging and many other conditions, including mental health issues. We remain very optimistic about these efforts.

在將電話轉給 Maggie 之前，讓我簡要討論一下我們的沉浸式醫療保健業務。正如我們過去所說，我們已經重組了我們在這一領域的工作，以更好地適應當前市場。這使我們能夠專注於沉浸式醫療保健的兩個最重要的方面。首先，確保使用真實沉浸式系統的患者對該技術做出積極反應。其次，我們正在與公共和私人的大型醫療保健提供者合作，以弄清楚如何將我們真正的沉浸式系統正確地引入治療工作流程中，以幫助需要康復的患者以及與衰老和許多其他疾病作鬥爭的患者，包括心理健康問題。我們對這些努力仍然非常樂觀。

I'll now turn the call over to Maggie to go over our financial results for the fourth quarter and the full year 2022.

我現在將電話轉給瑪吉，讓她回顧一下我們第四季度和 2022 年全年的財務業績。

Thank you, Adam. Good afternoon, everyone. Today, I will discuss the financial results for the fourth quarter and full year of 2022. Financial results on this call for revenue and gross margin are on a GAAP basis while operating expenses and operating income 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，亞當。大家下午好。今天，我將討論 2022 年第四季度和全年的財務業績。本次電話會議的收入和毛利率財務業績基於 GAAP，而營業費用和營業收入基於非 GAAP。我們發布的新聞稿中提供了相應的 GAAP 措施以及 GAAP 與非 GAAP 財務措施的調節。

For the fourth quarter ended December 31, 2022, our total revenues were $221.2 million, an increase of 8.4% reported and 10.5% in constant currency compared to the fourth quarter of 2021. Our geographic mix of sales in the quarter was 71% U.S. and 29% international. U.S. reported growth of 8.8% and our international regions increased 7.7% reported and 14.9% in constant currency. We see strong sequential growth in U.S. and Europe direct channels, offset by timing in international distributor orders.

截至 2022 年 12 月 31 日的第四季度，我們的總收入為 2.212 億美元，與 2021 年第四季度相比報告增長 8.4%，按固定匯率計算增長 10.5%。本季度我們的銷售地域組合為 71% 美國和29% 國際化。美國報告增長 8.8%，我們的國際地區報告增長 7.7%，按固定匯率計算增長 14.9%。我們看到美國和歐洲直接渠道的強勁連續增長，被國際分銷商訂單的時機所抵消。

Moving to revenue by franchise. Revenue from our Vascular business grew to $129.7 million in the fourth quarter of 2022, an increase of 14.2% reported and 15.4% in constant currency compared to the same period last year, driven by growth in the U.S. Revenue from our Neuro business was $91.5 million in the fourth quarter of 2022, an increase of 1.2% reported and 4.4% in constant currency compared to the same period a year ago, driven by the RED catheter launch in Europe.

通過特許經營轉向收入。 2022 年第四季度，我們血管業務的收入增長至 1.297 億美元，與去年同期相比增長 14.2%，按固定匯率計算增長 15.4%，這是受美國增長的推動。我們神經業務的收入為 9150 萬美元2022 年第四季度，在歐洲推出 RED 導管的推動下，與去年同期相比，報告增長 1.2%，按固定匯率計算增長 4.4%。

Moving to gross margins. Gross margin in the fourth quarter was slightly improved at 62.6% compared to 61.5% in the same quarter last year. While we have made great progress in labor efficiency at our Roseville manufacturing site, short-term disruptions from supply chain inconsistencies have had an impact on steady margin improvement. Looking forward to 2023, we target to achieve 100 to 200 basis point improvement driven by product mix and productivity offsetting inflation headwinds.

轉向毛利率。與去年同期的 61.5% 相比，第四季度的毛利率略有改善，為 62.6%。雖然我們在 Roseville 製造基地的勞動效率方面取得了很大進步，但供應鏈不一致造成的短期中斷對穩定的利潤率提高產生了影響。展望 2023 年，我們的目標是在產品組合和生產力抵消通脹逆風的推動下實現 100 至 200 個基點的改善。

Now on to our non-GAAP operating expenses, which exclude the amortization of acquired intangible assets of $2.4 million for this quarter and last quarter, respectively, and -- as well as nonrecurring research and development milestone, onetime expenses associated with the Sixense acquisition and amortization of acquired intangible assets of $42.6 million for the same quarter last year.

現在來看我們的非 GAAP 運營費用，其中分別不包括本季度和上季度收購的無形資產攤銷 240 萬美元，以及 - 以及非經常性研發里程碑，與 Sixense 收購相關的一次性費用和去年同期收購的無形資產攤銷額為 4260 萬美元。

Total operating expense for the quarter was $131.2 million or 59.3% of revenue compared to $123 million or 60% of revenue for the same quarter last year. In the fourth quarter of 2022, we had $1.5 million due to onetime costs for reorganization efforts, a continuation of future savings we previously discussed last quarter. Our research and development expenses for Q4 2022 were $18 million compared to $19.4 million for Q4 2021. SG&A expenses for Q4 2022 were $113.3 million or 51.2% of revenue compared to $103.5 million or 50.7% of revenue for Q4 2021 and $106.2 million or 49.7% of revenue last quarter.

本季度總運營費用為 1.312 億美元，佔收入的 59.3%，而去年同期為 1.23 億美元，佔收入的 60%。在 2022 年第四季度，由於重組工作的一次性成本，我們有 150 萬美元，這是我們之前在上個季度討論過的未來節省的延續。我們 2022 年第四季度的研發費用為 1800 萬美元，而 2021 年第四季度為 1940 萬美元。2022 年第四季度的 SG&A 費用為 1.133 億美元，佔收入的 51.2%，而 2021 年第四季度為 1.035 億美元，佔收入的 50.7%，1.062 億美元，佔收入的 49.7%上個季度的收入。

We are investing in resources to support our growth targets while maintaining discipline in discretionary spend. In 2023, we expect higher investment in clinical trials while leveraging our infrastructure investment made in 2022 to deliver operating margin expansion. We recorded operating income of $7.2 million or 3.3% of revenue in fourth quarter 2022, excluding the amortization of acquired intangible assets compared to an operating income of $2.5 million for the same period last year.

我們正在投資資源以支持我們的增長目標，同時保持可自由支配支出的紀律。到 2023 年，我們預計將增加對臨床試驗的投資，同時利用我們在 2022 年進行的基礎設施投資來擴大營業利潤率。我們在 2022 年第四季度的營業收入為 720 萬美元，佔收入的 3.3%，不包括所收購無形資產的攤銷，而去年同期的營業收入為 250 萬美元。

I will now summarize our full year performance. For the full year 2022, our total revenue was $847.1 million, which represent an increase of 13.3% reported and 15.5% in constant currency compared to full year 2021. Our geographic mix of sales in the year were 69.8% U.S. and 30.2% international. U.S. reported growth of 12.1% and our international regions increased 16.2% reported and 23.5% in constant currency compared to a year ago.

我現在將總結我們全年的表現。 2022 年全年，我們的總收入為 8.471 億美元，與 2021 年全年相比，報告的收入增長了 13.3%，按固定匯率計算增長了 15.5%。我們全年的銷售地域組合為 69.8% 美國和 30.2% 國際。與一年前相比，美國報告增長 12.1%，我們的國際地區報告增長 16.2%，按固定匯率計算增長 23.5%。

Revenue from our Vascular business for the full year of 2022 was $499.4 million, an increase of 22.1% reported and 23.6% in constant currency. Revenue from our Neuro business for the full year of 2022 was $347.7 million, an increase of 2.7% reported and 5.6% in constant currency. Our gross margin for the year was 63.2% of revenue compared to 63.6% of revenue for full year 2021. Excluding the amortization of acquired intangible assets of $8.3 million for 2022 and nonrecurring research and development milestones, onetime expenses associated with Sixense acquisition and amortization of acquired intangible assets of $42.6 million in 2021. In 2022, we had non-GAAP operating income for the full year of $14.4 million compared to our non-GAAP operating income of $35 million for 2021.

2022 年全年，我們血管業務的收入為 4.994 億美元，報告增長 22.1%，按固定匯率計算增長 23.6%。 2022 年全年神經業務收入為 3.477 億美元，報告增長 2.7%，按固定匯率計算增長 5.6%。我們今年的毛利率為收入的 63.2%，而 2021 年全年的毛利率為 63.6%。不包括 2022 年收購的 830 萬美元無形資產攤銷和非經常性研發里程碑、與 Sixense 收購相關的一次性費用和攤銷2021 年收購了 4260 萬美元的無形資產。2022 年，我們全年的非 GAAP 營業收入為 1440 萬美元，而 2021 年的非 GAAP 營業收入為 3500 萬美元。

Turning to cash flow and balance sheet. We ended the fourth quarter with a cash, cash equivalents and marketable security balance of $188 million. We expect positive operating cash flow trends to continue in 2023.

轉向現金流和資產負債表。第四季度末，我們的現金、現金等價物和有價證券餘額為 1.88 億美元。我們預計積極的經營現金流趨勢將在 2023 年繼續。

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

現在我想把電話轉給 Jason 來討論我們的指導。

Thank you, Maggie, and good afternoon, everyone. We reiterate our guidance for total revenue in 2023 to be $1 billion or more, representing year-over-year growth of at least 18%, which is an acceleration from 2022 total revenue of $847 million. Moreover, we expect our quarterly revenue growth rates to accelerate as the year progresses. Further, we expect to expand gross margins in 2023 toward our 70% plus objective within a few years with margins increasing from current levels in the first half of the year towards the mid-60% range in the second half. Lastly, we expect our operating margins to expand sequentially during 2023, approaching double digits as we exit the year.

謝謝你，Maggie，大家下午好。我們重申我們對 2023 年總收入為 10 億美元或更多的指導，同比增長至少 18%，比 2022 年的總收入 8.47 億美元有所加速。此外，我們預計我們的季度收入增長率會隨著時間的推移而加快。此外，我們預計將在幾年內將 2023 年的毛利率提高到 70% 以上的目標，而利潤率將從今年上半年的當前水平提高到下半年的 60% 左右。最後，我們預計我們的營業利潤率將在 2023 年連續擴大，並在年底接近兩位數。

I will now turn the call back to Adam for closing remarks.

我現在將把電話轉回給亞當，讓他發表結束語。

Thank you, Jason, Maggie and Jee. I'll be brief in my closing remarks. This is the dawning of the age of computer-orchestrated aspiration. With this technology, we can see to the point where removing blood clots from any part of the body becomes routine. It is very important to give special recognition to the entire team at Penumbra who over the course of almost 20 years stayed focused on this arc of innovation.

謝謝杰森、瑪姬和吉。我將在結束語中進行簡要介紹。這是計算機精心策劃的時代的曙光。有了這項技術，我們可以看到從身體任何部位清除血塊成為常規的地步。非常重要的是要特別表彰 Penumbra 的整個團隊，他們在將近 20 年的時間裡一直專注於這一創新弧線。

I admire you all so much. You never gave up. You kept working and working, sometimes against all odds, to deliver this extraordinary technology to the field. Also, it is important to give a special acknowledgment to Dr. Corey Teigen and Scott Teigen for their critical role in making this technology a reality. Thank you to them and the entire Penumbra team.

我非常欽佩你們。你從未放棄。您一直努力工作，有時不顧一切困難，將這項非凡的技術帶到現場。此外，特別感謝 Corey Teigen 博士和 Scott Teigen 博士在使這項技術成為現實方面發揮的關鍵作用。感謝他們和整個 Penumbra 團隊。

Thank you. Operator, we can now open the call to questions.

謝謝。接線員，我們現在可以打開問題電話了。

(Operator Instructions) And our first question will come from Pito Chickering of Deutsche Bank.

（操作員說明）我們的第一個問題將來自德意志銀行的 Pito Chickering。

You talked about sequential sort of revenue growth 3Q and 4Q and into 1Q. Is there any color that you can give us as we thinking about that growth or with Lightning Flash in the first quarter? And are you comfortable with $115 million of revenues from Lightning Flash in 2023?

您談到了第三季度和第四季度以及第一季度的連續收入增長。在我們考慮第一季度的增長或 Lightning Flash 時，您有什麼顏色可以給我們嗎？您對 2023 年 Lightning Flash 的 1.15 億美元收入感到滿意嗎？

Yes. So as you know, we don't guide quarterly, but we do expect the quarterly growth rate in the first quarter to be slightly higher than the sequential growth you saw fourth quarter over third quarter. As you move beyond the first quarter, the second quarter likely accelerates quite a bit with the launch of Lightning Flash still fresh and LIGHTNING BOLT at the end of this quarter. And in the back half of the year, we expect strong sequential growth rates as well, probably better than the first quarter sequentially and sort of in line with where we would expect to see second quarter.

是的。如您所知，我們不提供季度指導，但我們確實預計第一季度的季度增長率將略高於您看到的第四季度與第三季度的環比增長。隨著您超越第一季度，第二季度可能會加速很多，因為 Lightning Flash 仍然新鮮，LIGHTNING BOLT 將在本季度末推出。在今年下半年，我們預計環比增長率也將強勁，可能比第一季度環比好，並且與我們預期的第二季度一致。

Okay. And then the only -- go ahead.

好的。然後唯一的 - 繼續。

The only color I'd like to add to that is that's sort of the -- when you have a launch, not just one but two like we have with Flash and LIGHTNING BOLT, that's just sort of the normal sequence of what happens with getting into all these labs and making sure that you go through the value analysis maybe and everyone has it. It just has that sequence to it. And as you know, we're knee-deep and sort of responding to doctors asking for it as opposed to us asking them to buy it, which is a really, really nice phase to be in. And that's why you're going to see that kind of growth going.

我想添加的唯一顏色是——當你發射時，不僅僅是一個，而是兩個，就像我們使用 Flash 和 LIGHTNING BOLT 一樣，這只是獲得時發生的正常順序進入所有這些實驗室，並確保您可能進行了價值分析，並且每個人都有。它只是有那個順序。正如你所知，我們是在屈膝地回應醫生的要求，而不是我們要求他們購買，這是一個非常非常好的階段。這就是為什麼你要看到這種增長。

Okay. And then sticking on Lightning Flash. Can you give any details on what the reorder rate is from the physicians that are using it? And any early color on either market penetration gains from shifting from medical to mechanical thrombectomy or market share shifts?

好的。然後堅持閃電閃光。您能否詳細說明使用它的醫生的再訂購率是多少？從醫學取栓術到機械血栓切除術的市場滲透率或市場份額轉移的任何早期跡象？

Yes. We're a month into the launch. So let's take that into account to give you guys some sense. Needless to say, I think it's fairly -- I'm fairly confident in saying this, Lightning Flash is without a doubt the best launch we've ever had. And I only have said that one other time, and it turned out to be true. There's -- the use of this product, the excitement around it, the speed and efficacy, the safety profile have made this really just an extraordinary product. Obviously, we're in the middle of the quarter, and we'll give a lot more color at the end of the quarter on the next call, but this is a great launch.

是的。我們已經推出一個月了。因此，讓我們考慮到這一點，讓你們有所了解。不用說，我認為這是公平的——我非常有信心這樣說，Lightning Flash 毫無疑問是我們有史以來最好的發布。我只說過一次，結果證明是真的。有——這個產品的使用、圍繞它的興奮、速度和功效、安全性使它真的成為一個非凡的產品。顯然，我們正處於本季度中期，我們將在本季度末的下一次電話會議上提供更多顏色，但這是一個很棒的發布。

And our next question will come from Robbie Marcus of JPMorgan.

我們的下一個問題將來自摩根大通的羅比馬庫斯。

This is Rohin on for Robbie. Congrats on a nice quarter. I guess I just wanted to touch on pricing and how we should think about better mix, and how that reflects in gross margin and profitability this year and beyond. Can you comment a little bit about how much of gross margin expansion this year is due to kind of the general productivity improvements that you brought up versus the mix benefit that we should see from new products?

這是羅比的羅欣。祝賀一個不錯的季度。我想我只是想談談定價以及我們應該如何考慮更好的組合，以及這如何反映在今年及以後的毛利率和盈利能力上。您能否評論一下今年毛利率的增長有多少是由於您提出的總體生產率提高以及我們應該從新產品中看到的混合收益？

Yes. Maggie, why don't you take a shot at that?

是的。瑪吉，你為什麼不試一試呢？

Yes. Thanks for the question. I'll just comment on the gross margin impact first. As we mentioned before, we are on track to -- we're making great progress and on track to our 70% gross margin target. It is going to come from productivity improvement in transferring over to Roseville, product mix and price impact as well as longer-term lean initiatives. All three factors are going to -- has an impact to our 2023 gross margin target, and it's going to continue to improve beyond 2023. In 2023, we expect to see a little bit bigger contribution from product mix.

是的。謝謝你的問題。我先評論一下毛利率的影響。正如我們之前提到的，我們正朝著 - 我們正在取得很大進展並朝著我們 70% 的毛利率目標邁進。它將來自轉移到 Roseville 的生產率提高、產品組合和價格影響以及長期精益計劃。這三個因素都將對我們 2023 年的毛利率目標產生影響，並且在 2023 年之後將繼續改善。到 2023 年，我們預計產品組合的貢獻會更大一些。

Great. No, that's super helpful. I guess another one is just more focused on near-term trends. And you kind of touched on this, but I just wanted to get, now that we're like almost done with February, basically, and just wanted to see how -- or if you had any more detail on how the launch for Lightning Flash is shaping up in the contributions you can expect from both Flash as well as LIGHTNING BOLT in the near term, but as well as over the balance of the year? And I guess maybe kind of the specifics and split between those, if you can provide any color there, that would be really helpful.

偉大的。不，那超級有用。我想另一個只是更關注近期趨勢。你有點談到了這一點，但我只是想知道，現在我們基本上已經差不多完成了 2 月，只是想看看如何 - 或者你是否有關於 Lightning Flash 發布的更多細節Flash 和 LIGHTNING BOLT 在短期內以及在今年餘下時間裡的貢獻正在形成嗎？我想也許是具體細節和它們之間的區別，如果你能在那裡提供任何顏色，那將非常有幫助。

It's a great question, and obviously, in the middle of the quarter, we were talking about last quarter's numbers. It's a little tricky to sort of talking about that in the kind of detail maybe you want. That being said, as I've already said today, the launch of Flash is going extremely well. We're a month-plus into it, and the level of interest, the level of success we've seen is, obviously, driving people to want to order the product and continue to try it.

這是一個很好的問題，顯然，在本季度中期，我們在談論上一季度的數據。以您想要的那種細節來談論它有點棘手。話雖這麼說，正如我今天已經說過的，Flash 的發布進展得非常順利。我們已經進行了一個多月，我們所看到的興趣程度和成功程度顯然促使人們想要訂購該產品並繼續嘗試。

So we're just knee-deep in getting through that process and getting the product through all the various value analysis, committees and responding as fast as we can to that interest. We, obviously, haven't even launched LIGHTNING BOLT yet. So let us do some cases, and we'll be able to report that next quarter. But needless to say, it's a great time. It's exciting. It's fun to see the level of interest and reaction to and the success we're seeing with this. There's -- it's just one of those things that you get to do very rarely in a career in medtech, and we're pretty excited about it.

因此，我們只是竭盡全力完成該過程，並通過所有各種價值分析、委員會獲得產品，並儘快對這種興趣做出反應。顯然，我們甚至還沒有推出 LIGHTNING BOLT。所以讓我們做一些案例，我們將能夠在下個季度報告。但不用說，這是一個美好的時光。是興奮的。看到對此的興趣和反應程度以及我們看到的成功很有趣。有——這只是你在醫療技術職業生涯中很少做的事情之一，我們對此感到非常興奮。

Yes. Rohin, this is Jason. Just to add on to that. We believe -- and maybe this sort of goes to the heart of your question with respect to our guidance. We believe we have very strong visibility into the lower limit of our guidance range at that $1 billion level. But as Adam mentioned, this is really early in the launch of two very important products with respect -- so with respect to the upper end of guidance this year, we don't have -- yet have the same visibility to put an upper limit on it. So just give us a quarter.

是的。羅欣，這是傑森。只是為了補充這一點。我們相信 - 也許這就是您關於我們指導的問題的核心。我們相信，我們對 10 億美元水平的指導範圍下限有很強的預見性。但正如亞當所提到的，這真的是兩個非常重要的產品推出的早期 - 所以關於今年指導的上限，我們沒有 - 但具有相同的可見性來設置上限在上面。所以只給我們四分之一。

And now we take a question from Michael Sarcone from Jefferies.

現在我們來回答 Jefferies 的 Michael Sarcone 的問題。

So just wanted to follow up on Maggie's comments around short-term disruptions in the supply chain in 4Q, and just wanted to get a little more color there. And just can you talk about if any of those are continuing into '23, and how they may impact gross margin through the year?

所以只是想跟進 Maggie 關於第四季度供應鏈短期中斷的評論，並且只是想在那裡獲得更多顏色。你能談談這些是否會持續到 23 年，以及它們如何影響全年的毛利率？

Yes. Thanks for the question. I did mention that the supply chain inconsistency disruption is just short term. It affects only in terms of slowing down our gross margin improvement, but it likely will not affect us, the ability to meet demand and longer-term margin improvement opportunities.

是的。謝謝你的問題。我確實提到過供應鏈不一致中斷只是短期的。它只會影響我們毛利率改善的放緩，但它可能不會影響我們滿足需求的能力和長期利潤改善機會。

Okay. And then do you think you could comment a little more just on how you're thinking about operating expense cadence through the year?

好的。然後你認為你可以就你如何考慮全年的運營支出節奏發表更多評論嗎？

Yes. I think this year, we're going to continue to invest, but we're going to start seeing more leverage on the G&A infrastructure investment that we had last year. We're going to gradually see sequential operating margin improvement. And I think in Jason's guidance comment, we will continue to see improvement throughout the end of the year.

是的。我認為今年，我們將繼續投資，但我們將開始看到去年對 G&A 基礎設施投資產生更多影響。我們將逐漸看到連續的營業利潤率提高。我認為在 Jason 的指導評論中，我們將在今年年底繼續看到改進。

Yes. And the only thing I would add to that, Michael, is in the first, we expect to be profitable every single quarter. In the first quarter, as with every first quarter, we have two important national sales meetings as well as payroll taxes that are, obviously, germane to that quarter. As we move through the year, we expect to, by the end of the year, be approaching double-digit operating margins.

是的。邁克爾，我唯一要補充的是，首先，我們希望每個季度都能盈利。在第一季度，與每個第一季度一樣，我們有兩次重要的全國銷售會議以及顯然與該季度密切相關的工資稅。隨著我們度過這一年，我們預計到今年年底，營業利潤率將接近兩位數。

Next we have David Rescott of Truist.

接下來我們有來自 Truist 的 David Rescott。

First, so in the past, you've talked about market share gains, market growth and then pricing as being contributors to growth for Flash, not necessarily in that order, but just wondering when you think about BOLT, and then ultimately, Thunderbolt. If you'd be able to kind of characterize where you see the biggest amount of growth within each of those segments, coming from whether it's market share growth price, that would be helpful.

首先，在過去，您談到了市場份額增長、市場增長以及定價是閃存增長的貢獻者，不一定按這個順序，但只是想知道您什麼時候想到 BOLT，然後最終想到 Thunderbolt。如果你能夠從某種程度上描述你在每個細分市場中看到最大增長量的地方，這是否來自市場份額增長價格，那將是有幫助的。

You're talking about as it relates to LIGHTNING BOLT or both or any of those products? LIGHTNING BOLT?

你說的是因為它與 LIGHTNING BOLT 或兩者或任何這些產品有關？閃電？

LIGHTNING BOLT and then Thunderbolt.

LIGHTNING BOLT 然後 Thunderbolt。

Okay. So LIGHTNING BOLT is sort of similar to what we've said about Flash, where price will be the smallest of those three. And as it relates to market growth versus share gain. With that product, it's sort of -- they're almost the same thing depending on how you define it. As you know, we're -- from a mechanical product, we have the vast majority of share in the arterial already. But the biggest sort of opportunity comes from both people, physicians who are using tPA drip, catheter-directed lysis or open surgery. And so if those are classified as market growth-type thing, then that will by far be the biggest gain. If you were to classify those as using another tool, if you will, then that would be share gain from those two. That's the biggest pool right now.

好的。所以 LIGHTNING BOLT 有點類似於我們所說的 Flash，價格是這三者中最小的。並且因為它涉及市場增長與份額增長。對於那個產品，它有點——它們幾乎是一樣的，這取決於你如何定義它。如您所知，我們是 - 從機械產品開始，我們已經在動脈中佔據了絕大多數份額。但最大的機會來自於使用 tPA 滴注、導管導向裂解或開放手術的人和醫生。因此，如果這些被歸類為市場增長類型的東西，那麼這將是迄今為止最大的收益。如果您將這些歸類為使用另一種工具，如果您願意的話，那將是這兩種工具的份額收益。那是目前最大的游泳池。

All of those patients are still with our customers. If they're already getting catheter-drug lysis or they're getting surgery, they're with our customers or potential customers already. And so that will be the first goal is to go there. And for those of you who in January saw the video of LIGHTNING BOLT, it's pretty extraordinary, and we have a fairly high level of confidence around that product in the clinic because, obviously, we've been doing showcases with similar technology. And so we -- so it's not starting from a blank slate. And I think we'll see a lot of excitement from physicians who are using one of those two modalities switch the soonest. So it's -- depending on your terminology, it's either one of those, but it's from those two sources.

所有這些患者仍然與我們的客戶在一起。如果他們已經在進行導管藥物溶解或正在接受手術，那麼他們已經與我們的客戶或潛在客戶在一起了。因此，第一個目標就是去那裡。對於那些在 1 月份看過 LIGHTNING BOLT 視頻的人來說，它非常了不起，我們對臨床上的該產品有相當高的信心，因為很明顯，我們一直在用類似的技術進行展示。所以我們 - 所以它不是從一張白紙開始的。而且我認為我們會看到使用這兩種方式中的一種最快轉換的醫生會感到非常興奮。所以它是——取決於你的術語，它是其中之一，但它來自這兩個來源。

Okay. That's helpful. And then maybe stepping back kind of from a higher level on the neuro side. So I think at the International Stroke Conference, there was some positive data just around use of thrombectomy, the benefit of thrombectomy into some type of patients that are currently excluded in the guideline recommendations, meaning those with essentially larger infarct volumes, right? So when we think longer term about the potential market expansion opportunity from that indication, just wondering, initially, one, what your view is on that?

好的。這很有幫助。然後也許從神經方面的更高層次退後一步。所以我認為在國際中風會議上，有一些關於血栓切除術的積極數據，血栓切除術對目前指南建議中排除的某些類型患者的益處，這意味著那些梗塞體積較大的患者，對嗎？因此，當我們從該跡像中長期考慮潛在的市場擴張機會時，只是想知道，一開始，您對此有何看法？

And then when you think about the new launch, maybe market expansion, just regaining share, some of the grassroots efforts that have been going on in the local kind of state and local levels to reaccelerate potentially underlying neuro thrombectomy growth rate, how would you just kind of think about the 3 or 4 of those in your view as it relates to reaccelerating your kind of U.S. neuro thrombectomy growth rates?

然後當你想到新的發布，也許是市場擴張，只是重新獲得份額，一些在地方州和地方層面正在進行的基層努力，以重新加速潛在的潛在神經血栓切除術增長率，你會如何考慮一下您認為與重新加速您的美國神經血栓切除術增長率有關的 3 或 4 個？

Yes. I think in the stroke market, specifically, we've been successful in the last couple of years because of share gain. The RED series are back with a decent amount of share and that's continuing. We mentioned in the prepared remarks that we have RED 43 and an access tool. I think that will continue to drive share gain. As it relates to the market growth, we're going to always remain not just hopeful and optimistic, but I think it's grounded in a good sense of reality that as you see data that comes out, like you alluded to ISC, which is -- I think a lot of the physicians in this field believe that, but it really, really it's nice to see that kind of rigorous data that supports it as well as products just getting easier and easier, not just with the RED series and the additions that I talked about, but then ultimately, with Thunderbolt.

是的。我認為在中風市場，具體而言，由於份額增加，我們在過去幾年取得了成功。 RED 系列以可觀的份額回歸，並且還在繼續。我們在準備好的評論中提到我們有 RED 43 和一個訪問工具。我認為這將繼續推動份額增長。由於它與市場增長有關，我們將始終保持不僅充滿希望和樂觀，而且我認為它基於良好的現實感，正如你看到的數據出來的那樣，就像你提到的 ISC，這是 - - 我想這個領域的很多醫生都相信這一點，但真的，真的很高興看到支持它的那種嚴格數據以及產品變得越來越容易，而不僅僅是 RED 系列和附加產品我談到過，但最終還是用 Thunderbolt。

We're really set up for all of the things that could potentially limit people getting successfully treated to sort of make those excuses go away, if you will, and drive growth again. So it's hard to predict them. We've never been that good at predicting over 7 or 8 years now that we've been talking about stroke growth, that growth in an exact way. But I think you're seeing everything line up in a positive way for a number of years now of sort of reengagement and growth. And it's hard to put an exact number on that, but it feels like that's happening in the field now.

我們真的為所有可能限制人們獲得成功治療的事情做好了準備，以便讓這些藉口消失，如果你願意的話，並再次推動增長。所以很難預測它們。既然我們一直在談論中風增長，那麼我們從來沒有那麼擅長預測超過 7 或 8 年的增長，這種增長是以一種精確的方式。但我認為，多年來，你看到一切都以積極的方式排列，重新參與和增長。很難給出一個確切的數字，但感覺現在這個領域正在發生這種情況。

Now we'll take a question from Ryan Zimmerman of BTIG.

現在我們將接受 BTIG 的 Ryan Zimmerman 的提問。

Very exciting to see all the products are coming out. I wanted to just ask first on the guidance and the $1 billion plus kind of leaves a lot of room to go higher. And I'm wondering if you can elaborate on kind of how you think about what's implied in the guidance from a market share gain perspective? Because if I understand correctly, you're not assuming market share gains from Lightning Flash or LIGHTNING BOLT at present.

很高興看到所有產品都問世了。我想先問一下指導，10 億美元以上還有很大的上升空間。我想知道您是否可以從市場份額增加的角度詳細說明您如何看待指南中暗示的內容？因為如果我理解正確的話，你目前並沒有從 Lightning Flash 或 LIGHTNING BOLT 中獲得市場份額。

No, we are. So let me walk you through it just a little bit, Ryan. First thing, let's start with the guidance itself. So the lower limit of $1 billion is, as I mentioned in the prepared remarks, an acceleration in growth to 18%. And I think you're going to appreciate a company at this scale comparing against nearly and $850 million in 2022. That's a significant projection in and of itself. As I mentioned, given the profoundly important aspects of these 2 technologies and the large number of patients that both of these new technologies, Lightning Flash and LIGHTNING BOLT can help. We don't have the kind of visibility that we -- right now that we do on the lower limit, we believe. So as we move into the next -- give us another quarter, we think we'll have more visibility. But as it relates to share, as Adam mentioned, there are 3 components to our growth profile. The least catalytic is the price. The two most catalytic will be share gain and market growth.

不，我們是。因此，讓我向您介紹一下，Ryan。首先，讓我們從指南本身開始。因此，正如我在準備好的發言中提到的那樣，10 億美元的下限是增長加速到 18%。而且我認為，與 2022 年的近 8.5 億美元相比，你會欣賞這種規模的公司。這本身就是一個重要的預測。正如我所提到的，鑑於這兩種技術的極其重要的方面以及這兩種新技術的大量患者，Lightning Flash 和 LIGHTNING BOLT 可以提供幫助。我們沒有那種能見度，我們相信，現在我們在下限做的那樣。因此，當我們進入下一個階段時——再給我們一個季度，我們認為我們會有更多的知名度。但正如亞當所提到的，與份額有關，我們的增長概況有 3 個組成部分。催化作用最小的是價格。最具催化作用的兩個將是份額增加和市場增長。

Okay. Understood. And then Adam, I was reviewing the transcript, and I may have missed this, but I didn't hear timing on Thunderbolt enrollment completion and submission and then subsequent approval. And so I was wondering if you could maybe clarify -- maybe I missed it, but I don't think I heard it.

好的。明白了。然後亞當，我正在審查成績單，我可能錯過了這個，但我沒有聽到 Thunderbolt 註冊完成和提交以及隨後批准的時間。所以我想知道你是否可以澄清 - 也許我錯過了，但我想我沒有聽到。

No, I didn't give a specific prediction. And as you know, predicting the enrollment of an emergent disease like stroke is not something that anyone -- if anyone says they can do that, I would discount that prediction. So we're not going to do that. What we have said is, we're doing fine. It's on track, and we're feeling good about that. That being said, we also said that there is no Thunderbolt in our projections for 2023 from a revenue standpoint. So we're not saying -- and don't read that as it's not going well. It is, but we're also being cautious in our prediction that Thunderbolt is -- we will do fine and do all the things we said we're going to do without Thunderbolt in the numbers for this year.

不，我沒有給出具體的預測。正如你所知，預測像中風這樣的突發疾病的登記不是任何人都能做的——如果有人說他們可以做到，我會打折扣這個預測。所以我們不會那樣做。我們所說的是，我們做得很好。它走上正軌，我們對此感覺很好。話雖如此，我們還表示，從收入的角度來看，我們對 2023 年的預測中沒有 Thunderbolt。所以我們不是說 - 也不要閱讀它，因為它進展不順利。確實如此，但我們對 Thunderbolt 的預測也持謹慎態度——我們會做得很好，並按照我們所說的，在今年的數字中沒有 Thunderbolt 的情況下我們將要做的所有事情。

And next, we have Mike Matson of Needham.

接下來，我們有來自 Needham 的 Mike Matson。

I guess I'll start with the -- just the RED catheter. So it did look like the growth maybe improved a little on the neuro side. Can you just comment on how those are doing in Europe? I think you launched them kind of late in the third quarter and so this is the first full quarter they were out there. And then I had a follow-up on RED 43.Can you maybe just talk about sort of where that fits in the lineup and how it's different from the other catheters?

我想我將從——只有紅色導管開始。所以看起來神經方面的增長確實有所改善。你能評論一下歐洲的情況嗎？我認為你在第三季度晚些時候推出了它們，所以這是他們在那裡的第一個完整季度。然後我對 RED 43 進行了跟進。你能不能談談它在陣容中的位置以及它與其他導管的不同之處？

Sure. Let me start backwards. We'll start with RED 43, and then we'll answer the larger question about the RED series in Europe, and I can broaden that question to the U.S. as well. RED 43, early days, as you know, in terms of getting it out there and getting it through the various value analysis committees. But the cases that have happened and the people have done have really, really liked it. It's a great sort of coaxial catheter plus the ability to have a catheter that size that can go distal has been -- people have just really, really responded to it. We're particularly proud of the design work that has gone into that catheter, and I think it's a clear need in the market.

當然。讓我從頭開始。我們將從 RED 43 開始，然後我們將回答有關歐洲 RED 系列的更大問題，我也可以將這個問題擴大到美國。 RED 43，正如你所知，就發布和通過各種價值分析委員會而言，早期。但是已經發生的案例和人們所做的事情真的非常喜歡它。它是一種很棒的同軸導管，而且具有可以延伸到遠端的尺寸的導管的能力——人們真的、真的對它做出了回應。我們對該導管的設計工作感到特別自豪，我認為這是市場上的明確需求。

As it relates to the general franchise that RED has brought, both in Europe and in the U.S., it's been a great launch. We really saw it start in the fourth quarter of 2021. We saw a bolus of that, which actually kind of hurt us a little on the comp right now because it was a great launch. But that being said, it has continued really strongly and taking share. So even in a market that isn't now growing, that franchise has continued to do well because more and more people are using it and that's what you want. You want a product that's good, that is that good that where the mouth travels and people try it and they stick with it, and that's what's happening with the RED series. And obviously, that's critically important to the success of Thunderbolt because those catheters are paired with Thunderbolt. And so if those catheters are getting the reaction that they're getting, they're trackable, the catheters people want to use, obviously, moving on and adding Thunderbolt to that becomes that much easier.

由於它涉及到 RED 在歐洲和美國帶來的一般特許經營權，因此它是一個很棒的發布。我們真的看到它從 2021 年第四季度開始。我們看到了其中的一大塊，這實際上對我們現在的競爭造成了一些傷害，因為這是一個很好的發布。但話雖這麼說，它仍然非常強勁地繼續發展並佔據份額。因此，即使在一個現在沒有增長的市場中，該特許經營權也繼續表現良好，因為越來越多的人在使用它，這就是你想要的。你想要一個好產品，好到口口相傳，人們嘗試並堅持下去，這就是 RED 系列正在發生的事情。顯然，這對 Thunderbolt 的成功至關重要，因為這些導管與 Thunderbolt 配對。因此，如果這些導管得到他們正在得到的反應，它們是可追踪的，人們想要使用的導管，顯然，繼續前進並將 Thunderbolt 添加到其中變得容易得多。

Okay. And then just on the Thunder trial, I may have asked this on a prior call, I can't remember to be honest, but will we see that data before you submitted the FDA or after you submit it or at some point before the product is actually launched?

好的。然後就 Thunder 試驗而言，我可能在之前的電話中問過這個問題，老實說我不記得了，但我們會在您提交 FDA 之前或之後或在產品發布之前的某個時候看到該數據真的推出了嗎？

It's hard to tell. It will depend on when that data is ready. If it happens to be ready and there's a big meeting that it can be presented on before it's made otherwise public, sure, then you would see it. If the timing of that doesn't work, we're, obviously not going to wait to submit it to the FDA in order to present it at the meeting. So it really just depends on the timing, and at this point, that's hard to predict.

很難說。這將取決於數據何時準備就緒。如果它恰好準備就緒，並且可以在一個大型會議上展示它，然後再公開，那麼你肯定會看到它。如果時機不對，我們顯然不會等到將其提交給 FDA 才能在會議上展示。所以這真的只取決於時間，而在這一點上，這很難預測。

And next, we have Shagun Singh of RBC.

接下來，我們有 RBC 的 Shagun Singh。

Looking forward to 2023. So just with respect to the questions, I was just wondering if you could elaborate on any apparent clinical advantages of Flash in early cases with respect to maybe clot removal time. You did mention speed, efficacy and safety. Any way to quantify that? And are you seeing greater uptake in PE or DVT cases?

期待 2023 年。所以關於問題，我只是想知道您是否可以詳細說明 Flash 在早期病例中的任何明顯的臨床優勢，可能與血塊清除時間有關。你確實提到了速度、有效性和安全性。有什麼方法可以量化嗎？您是否看到 PE 或 DVT 病例的接受度更高？

And then with respect to my second question, I was just wondering if you can give us a little bit of an update on clinical trial activity. And then on Thunder, I specifically just wanted to get a sense of enrollment. I think, as I understand it, patients have to be treated in a certain time frame. Is that limiting enrollment in any way? Or is it on track?

然後關於我的第二個問題，我只是想知道你是否可以向我們提供一些關於臨床試驗活動的最新信息。然後在 Thunder 上，我特別想了解一下註冊情況。我認為，據我了解，患者必須在一定的時間範圍內接受治療。這是否以任何方式限制入學？還是走上正軌？

All right. I'm going to try to remember all these. I try to write it down. I might need a prompt. The first, you asked the question about safety and speed and all that, and then the answer is yes. All those things are good, and Flash has all those things. And again, it's one of those rare things in at least our experience in 20-some-odd years in this field that a product is that good and has the kind of word of mouth that's following it around. So it's noticeable once you use it, and we're particularly happy about that because again, it goes to how well patients can be treated. The next question was still Flash, and I tried to write fast and then we went into Thunderbolt. So remind me of the next question.

好的。我會努力記住所有這些。我試著把它寫下來。我可能需要一個提示。首先，你問了關於安全和速度等等的問題，然後答案是肯定的。所有這些都很好，Flash 擁有所有這些東西。再一次，至少在我們在該領域 20 多年的經驗中，這是一件罕見的事情，即產品如此出色並且具有跟隨它的那種口碑。所以一旦你使用它就會很明顯，我們對此特別高興，因為這又關係到患者的治療效果。下一個問題仍然是 Flash，我試著寫得很快，然後我們進入了 Thunderbolt。所以提醒我下一個問題。

Well, actually, just a follow-up, if you can quantify like in terms of speed or anything, if you can quantify it. And then the question was really about if you're seeing greater uptake in PE or DVT cases.

好吧，實際上，只是一個跟進，如果你可以量化速度或任何東西，如果你可以量化它。然後問題實際上是關於您是否看到 PE 或 DVT 病例的吸收率更高。

Yes, that's right. So how do you quantify it? Every case is different. Obviously, DVT and PE are different. And you can have easy -- basic P cases and more challenging ones and vice versa in DVT. So hard to quantify that in terms of numbers that, that's what you're looking for. The answer is the impression. The reality is, people who are using it are reacting to that very positively, like, wow, that was amazing. That was so easy, so fast and powerful, and it just got the job done. And so it's hard to quantify that.

恩，那就對了。那麼如何量化呢？每個案例都是不同的。顯然，DVT和PE是不同的。在 DVT 中，您可以擁有簡單的基本 P 案例和更具挑戰性的案例，反之亦然。很難用數字來量化，這就是你要找的東西。答案是印象。事實上，使用它的人對此反應非常積極，就像，哇，太棒了。那是如此簡單、如此快速和強大，而且它剛剛完成了工作。因此很難對其進行量化。

We don't -- we're not running a trial on it now. So there's no number that I can share with you that have any kind of validity. It's not like sort of collection of self-reported stuff. So I think it just -- it is notably performing better than what they're used to. So that's that.

我們沒有——我們現在沒有對其進行試驗。因此，我無法與您分享具有任何有效性的數字。它不像某種自我報告的東西的集合。所以我認為它只是——它的表現明顯比他們習慣的要好。就是這樣。

Between DVT and PE, I think we're seeing a real mix. I think, for people who are using it -- I mean many are using in both. The doctors are reacting equally good or equally favorably in both of those. There's not at all clear difference between, oh, well, I like it, but only for this versus that. If you are responding to it and again, the vast, vast majority are who are using it, it's for both DVT and PE.

在 DVT 和 PE 之間，我認為我們看到了真正的混合。我認為，對於使用它的人來說——我的意思是很多人都在使用這兩種方法。醫生對這兩者的反應同樣好或同樣有利。哦，好吧，我喜歡它之間並沒有明顯的區別，但只是為了這個和那個。如果你一次又一次地回應它，絕大多數人都在使用它，它適用於 DVT 和 PE。

On the Thunderbolt question, really hard, as I've said a couple of times, to quantify enrollment for you, stroke enrollment. And I've done lots and lots of stroke trials that have been involved with them over the years. It goes in fits and starts. You might go 4 days without a case, and then you'll have 5 cases in 2 days that kind of thing. That's the nature of a stroke trial. That's not different in the stroke trial, but as I've said, it's -- we're in good shape, on track. And again, cautiously, we have made sure we are counting on this product in which we don't control the timing of the trial for any revenue in 2023. So from that standpoint, I think everyone can rest assured that we're in pretty good shape and aren't out on a limb on that topic.

關於 Thunderbolt 問題，真的很難，正如我已經說過幾次的那樣，要為你量化入學率，中風入學率。多年來，我做了很多涉及他們的中風試驗。它時斷時續。你可能 4 天沒有案件，然後你會在 2 天內有 5 個案件之類的事情。這就是中風試驗的性質。這在中風試驗中並沒有什麼不同，但正如我所說的那樣——我們的狀態很好，在正軌上。再一次，謹慎地，我們確保我們指望這個產品，我們無法控制 2023 年任何收入的試驗時間。所以從這個角度來看，我認為每個人都可以放心，我們在相當身材很好，在這個話題上也毫不猶豫。

And now we'll take a question from Matt O'Brien with Piper Sandler.

現在我們將與 Piper Sandler 一起接受 Matt O'Brien 的提問。

This is Sam on for Matt. I guess, for first, I was wondering if you could provide any more information or any color on surgeon training for Lightning Flash and any feedback you've gotten from physicians there.

這是山姆代替馬特。我想，首先，我想知道您是否可以提供更多關於 Lightning Flash 外科醫生培訓的信息或顏色，以及您從那裡的醫生那裡得到的任何反饋。

Sure. Surgeon training or interventional training, whichever the specialty is, physician training, it's slightly different, depending on if the physician has used one of our Lightnings in the past. If they have, setup is very similar. If they haven't, we just have to do an in-service and get their lab squared away. But again, we've been doing that for a while. So it's relatively straightforward.

當然。外科醫生培訓或介入培訓，無論哪個專業，醫生培訓，都略有不同，這取決於醫生過去是否使用過我們的 Lightnings。如果有，設置非常相似。如果他們還沒有，我們只需要進行一次服務並讓他們的實驗室擺平。但是，我們這樣做已經有一段時間了。所以它相對簡單。

The only real difference for people who've used Lightning either 7 or 12 or versus Lightning Flash is, there is -- the algorithm is different and the feedback is different. And so there is -- and it's a lot more powerful. So there's just basic training around how to think about that and how to read, what the visual cues are on the lights and the sound. Again, not different than anything we've done in the past and certainly not providing any form of sort of barrier for adoption, and it can be done pretty simply by our field team.

對於使用過 Lightning 7 或 12 或與 Lightning Flash 的人來說，唯一真正的區別是——算法不同，反饋也不同。所以有 - 而且它更強大。所以只有關於如何思考和閱讀的基本培訓，燈光和聲音上的視覺提示是什麼。同樣，這與我們過去所做的任何事情都沒有什麼不同，當然也沒有為採用提供任何形式的障礙，而且我們的現場團隊可以非常簡單地完成它。

Great. And I guess just a little final point on that. How -- would you be able to tell us how many have previously used Lightning and how many have not previously?

偉大的。我想這只是最後一點。如何——你能告訴我們有多少人以前使用過 Lightning，有多少人以前沒有使用過嗎？

Really hard to know that number. We don't certainly look at that and track that. I can tell you, we certainly have had a number of our current customers want to switch over. Obviously, that shouldn't surprise anyone. But what has been really nice to see is folks that for years and years have said, "I need a bigger catheter" are now very, very much responding to Flash. And as we all know, what they wanted is a much more powerful system than maybe Lightning 12 provided, and now they have it. And it's -- so for people who haven't been using us, the reaction and the response has been really, really heartening to see that what we did is, we made and gave the product that everyone wanted. What everyone has been asking for, we've really given them, and that's sort of what we're supposed to be doing. So we're pretty excited about that.

真的很難知道這個數字。我們當然不會查看並跟踪它。我可以告訴你，我們當然有一些現有客戶想要轉換。顯然，這不應該讓任何人感到驚訝。但真正令人高興的是，多年來一直說“我需要一根更大的導管”的人們現在對 Flash 的反應非常非常好。眾所周知，他們想要的是一個比 Lightning 12 提供的系統更強大的系統，現在他們擁有了。而且它 - 所以對於那些沒有使用過我們的人來說，看到我們所做的是，我們製造並提供了每個人都想要的產品，反應和回應真的非常令人振奮。每個人都在要求的，我們真的給了他們，這就是我們應該做的。所以我們對此感到非常興奮。

And now we will go to Lei Huang of Wells Fargo.

現在我們將去富國銀行的黃雷。

It's Lei calling in for Larry Biegelsen. Can you hear me?

是雷打電話給拉里·比格爾森。你能聽到我嗎？

Yes.

是的。

I want to go back to gross margin. You talked about gross margin expansion of 100 to 200 basis points this year, and it sounds like most of that is coming in second half of the year. Can you just give a little more color in terms of what gets better between first half and second half to drive that margin expansion? And as part of that, can you talk about how you're thinking about China DVT and how that's reflected in that outlook? And then I have a follow-up.

我想回到毛利率。你談到今年毛利率增長 100 到 200 個基點，聽起來大部分會在今年下半年實現。您能否就上半年和下半年之間的哪些方面變得更好來推動利潤率增長提供更多的顏色？作為其中的一部分，您能否談談您對中國 DVT 的看法以及它如何反映在該展望中？然後我有一個後續行動。

Okay. Yes. No, thanks for the question. So two factors here. As we continue to increase proportionally thrombectomy volume versus embolization, you're going to see continued product mix impact to our gross margin. So that is one factor why second half will be stronger than the first half. And also in the first half where our operation team is mainly focusing on leading demand for these new product launches, so their priority focus right now is not on achieving optimal level of yield performance and labor efficiency, and we can continue to see those improvements continue on in the second half of the year.

好的。是的。不，謝謝你的提問。所以這裡有兩個因素。隨著我們繼續按比例增加血栓切除術與栓塞術的比例，您將看到產品組合對我們毛利率的持續影響。所以這就是下半場比上半場強的一個因素。而且在上半年，我們的運營團隊主要關注對這些新產品發布的領先需求，因此他們現在的首要任務不是實現最佳的產量表現和勞動效率水平，我們可以繼續看到這些改進繼續在今年下半年。

Yes. Lei, I'll take the question on China. We've been really, really happy with the bounce back really from a broader health care perspective in China. As you know, in the latter part of 2022, namely November and December, many hospitals were shut down or doing relatively lower levels of procedures relative to what they typically do just because of the pandemic. And the doctors in China seem to be really bouncing back, working overtime, trying to help their patients and that is a very positive thing. As you know, we have a very strong partnership with Genesis really in the early stages of that from a long-term perspective. So we feel good about China writ large, including what we have in our forecast with respect to the volume-based pricing that you mentioned.

是的。雷，我來回答關於中國的問題。從更廣泛的醫療保健角度來看，我們對中國的反彈真的非常非常滿意。如您所知，在 2022 年下半年，即 11 月和 12 月，許多醫院因大流行而關閉或進行相對於通常所做的相對較低水平的程序。中國的醫生似乎真的恢復了活力，加班加點，努力幫助他們的病人，這是一件非常積極的事情。如您所知，從長期的角度來看，我們確實在早期階段與 Genesis 建立了非常牢固的合作夥伴關係。因此，我們對中國感到滿意，包括我們對您提到的基於數量的定價的預測。

Got it. And then my second question, just bigger picture. Penumbra is known for technology improvement and iterations over the years. As you think about your new AI-orchestrated technology, how does that change the way you approach device iteration going forward and your competitive moat?

知道了。然後我的第二個問題，更大的圖景。 Penumbra 多年來以技術改進和迭代而聞名。當您考慮新的 AI 編排技術時，這將如何改變您處理未來設備迭代的方式和您的競爭護城河？

So, it's -- there's two parts to that question. One is, how does it change our innovation or ability to do things. The answer is it doesn't. We're going to keep working on this. What we have now with Flash is amazing. Can we make it better? I don't know. We haven't done enough cases in 1.5 months to really say where the improvement is that hasn't been obvious, which is a positive for us. But I'm sure there will be things that we can continue to tweak. We will always do that. And our R&D team over the years has proven that they're so good at doing that.

所以，這個問題有兩個部分。一是，它如何改變我們的創新或做事的能力。答案是沒有。我們將繼續努力。我們現在擁有的 Flash 令人驚嘆。我們可以讓它變得更好嗎？我不知道。我們在 1.5 個月內沒有做足夠多的案例來真正說明改進不明顯的地方，這對我們來說是積極的。但我相信我們可以繼續調整一些東西。我們將永遠這樣做。多年來，我們的研發團隊已經證明他們非常擅長這樣做。

What I said on the call and I really mean this, we now, for the first time, really can see any moment where getting clot out is so routine. We're not there yet, but we can see it. And the innovation will take us from where we are to that point, which is a much shorter journey than the journey that took us all these years to get to this point. And that's very heartening, having spent a long time doing this.

我在電話中所說的，我的意思是，我們現在第一次真正可以看到任何時候清除血塊是如此例行公事。我們還沒有到那一步，但我們可以看到它。創新將把我們從現在的位置帶到那一點，這比我們花了這麼多年才走到這一步的旅程要短得多。這是非常令人振奮的，因為花了很長時間這樣做。

The competitive moat part, I hate to sort of talk about our products that way because what we do is focus, obviously, on innovation and the patients. It's not about other companies and what they do. But obviously, we have IP around this whole mechanism and the way it works. And obviously, we expect people will honor that IP, and if they don't, we'll have a conversation about it. We're not -- that's a different type of dynamic than we've ever had before where people can copy and do things and have, but I don't think it will slow down our drive to get these products tuned perfectly. That being said, it's -- as I said, it's the dawning of a great new era. It's fun.

競爭護城河部分，我討厭以這種方式談論我們的產品，因為我們所做的顯然是專注於創新和患者。這與其他公司及其所做的無關。但顯然，我們擁有圍繞整個機制及其工作方式的知識產權。顯然，我們希望人們會尊重該 IP，如果他們不尊重，我們將就此進行對話。我們不是——這是一種不同於以往的動態類型，人們可以在其中復制和做事並擁有，但我認為這不會減慢我們對這些產品進行完美調整的動力。話雖如此，正如我所說，這是一個偉大新時代的曙光。好有趣。

And now we'll take a question from Bill Plovanic of Canaccord.

現在我們將接受來自 Canaccord 的 Bill Plovanic 的提問。

First question is on Lightning Flash rollout. I was wondering if you could just help us understand when did you transition from LMR to full market launch? And when you do that going to full market launch, do you initially start with your own customers? Or do you make it more broad based? And how do we think about that scale up over time? And then with the VAC process, what does the time look like to get through the VAC at the hospitals these days to where you're really -- you're getting them, you're getting them trial it, but how long does it take to get through and kind of get on the shelves into daily use?

第一個問題是關於 Lightning Flash 的推出。我想知道您是否可以幫助我們了解您是什麼時候從 LMR 過渡到全面上市的？當您這樣做以全面推出市場時，您是否首先從您自己的客戶開始？或者你讓它的基礎更廣泛？我們如何考慮隨著時間的推移擴大規模？然後通過 VAC 流程，這些天通過醫院的 VAC 到你真正的地方的時間是什麼樣的 - 你正在接受他們，你正在讓他們試用它，但是它需要多長時間需要通過並上架進入日常使用嗎？

Yes. Let me try to attack all those questions. The first is, we are -- we went through our evaluation phase relatively quickly given the performance of this product. And I think the large conference in early January, we announced that we were already through that. So we have been in sort of the launch mode for about a month and a couple of weeks now. That being said, what does that look like? Every launch can be different. You can -- different companies do different things. On this launch, we are basically just trying to get through all the order process. Anyone who wants it is starting the process in their hospitals to buy it. Some of those can be very quick, and we can satisfy some of those orders for whatever reason the hospital wanted or the physician is able to push it through within a matter of a week or 2 or 3. Others take much, much longer and some can take several months to go through that process.

是的。讓我試著回答所有這些問題。首先，我們是——鑑於該產品的性能，我們相對較快地完成了評估階段。我認為在 1 月初的大型會議上，我們宣布我們已經通過了。所以我們已經處於啟動模式大約一個月零幾週了。話雖這麼說，那看起來像什麼？每次發射都可能不同。你可以——不同的公司做不同的事情。在這次發布會上，我們基本上只是想完成所有的訂購流程。任何想要它的人都在他們的醫院開始購買它的過程。其中一些可能很快，我們可以出於醫院想要的任何原因滿足其中一些訂單，或者醫生能夠在一周或 2 或 3 天內完成訂單。其他人需要更長、更長時間和一些可能需要幾個月的時間來完成這個過程。

So there's a wide range. What is happening now is, we're just going through that process. And anyone, again, who wants it is starting that process with us and some are being satisfied pretty quickly and others will take more time. We're not -- we can't really quantify that, obviously, but needless to say that, that is what the team is doing in addition to, obviously, being there for their first cases and getting the folks reoriented to the algorithms of this particular product. So again, we're in really good shape. As I said, this has been one of the most exciting times that I've ever had, and this will be our most successful launch. I say that with LIGHTNING BOLT coming right behind it. So I hope I get to say it again soon, but it's a lot of fun. So thanks for the question, Bill.

所以範圍很廣。現在發生的事情是，我們正在經歷這個過程。再次，任何想要它的人都在與我們一起開始這個過程，有些人很快就滿意了，而另一些人則需要更多時間。我們不是 - 我們無法真正量化，顯然，但不用說，這就是團隊正在做的事情，此外，顯然，他們在那里處理他們的第一個案例並讓人們重新定位到算法這個特定的產品。再一次，我們的狀態非常好。正如我所說，這是我經歷過的最激動人心的時刻之一，這將是我們最成功的發布。我說閃電緊隨其後。所以我希望我能很快再說一遍，但這很有趣。謝謝比爾的提問。

And then when you launch, do you launch to your existing customers first or...

然後當你推出時，你是先向現有客戶推出還是......

Yes. No, we don't discriminate. We're happy to have all customers. And what I've said, which is kind of a really unique aspect of this is, we're getting approached by people who typically aren't using Lightning at a pretty large scale to try to use it and buy it. And again, they have to go through the process and go through value analysis committees and so on. But that is the level of sort of discussion and interest around this that made that a lot more fun, obviously. So it's just a matter of going through the process and doing it all right so that we're following all hospitals rules and getting them in the right way.

是的。不，我們不歧視。我們很高興擁有所有客戶。我說過，這是一個非常獨特的方面，我們正在接觸那些通常不會大規模使用閃電網絡的人，他們會嘗試使用它併購買它。同樣，他們必須通過流程並通過價值分析委員會等。但顯然，正是圍繞這一點的討論和興趣讓這件事變得更加有趣。因此，這只是完成整個過程並正確執行的問題，以便我們遵守所有醫院規則並以正確的方式進行。

And then on LIGHTNING BOLT, if I could, you're in LMR or the eval right now. It's -- I think the comments were that you'll go into kind of full market launch exiting March. Do you -- given that you've already kind of put Flash through, which is that similar technology, does that allow you to kind of accelerate the VAC process and order process? Or is it the same kind of steps you've got to roll through when that goes full market?

然後在 LIGHTNING BOLT 上，如果可以的話，你現在在 LMR 或 eval 中。它是——我認為評論是你將在 3 月份開始全面推出市場。你 - 鑑於你已經有點通過 Flash，這是類似的技術，這是否允許你加速 VAC 流程和訂購流程？還是當它進入全面市場時，你必須經歷同樣的步驟？

Yes. It's really -- actually, great question. I don't think you get any bonus, if you will, for saying, "Hey, now we want to do it again. Thanks for doing all this work, and now we want to do it again." I don't think that helps us. I do think there will be, obviously, once that launch happens, the ability to potentially combine them, but we won't see that until into April timeframe and beyond. So for the next month, it's really going to be still Flash, as I've said, and we'll sort of make sure LIGHTNING BOLT goes through the early cases and all that stuff. But yes, once we get into the second quarter, I think you can combine these as one process through the value analysis committee might make it more efficient.

是的。這真的 - 實際上，是個好問題。我不認為你會得到任何獎金，如果你願意的話，因為你說，“嘿，現在我們想再做一次。感謝你所做的所有這些工作，現在我們想再做一次。”我認為這對我們沒有幫助。我確實認為，很明顯，一旦發布發生，就有可能將它們結合起來，但我們要到 4 月及以後才能看到。因此，在下個月，正如我所說，它實際上仍然是 Flash，我們將確保 LIGHTNING BOLT 通過早期案例和所有這些東西。但是，是的，一旦我們進入第二季度，我認為你可以通過價值分析委員會將這些作為一個過程結合起來，這可能會提高效率。

And with that, that does conclude today's question-and-answer session. Ms. Hamlyn-Harris, I'd like to turn the call back to you for additional or closing comments.

這樣，今天的問答環節就結束了。 Hamlyn-Harris 女士，我想將電話轉回給您以徵求更多意見或結束意見。

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 first quarter call.

謝謝你，運營商。代表我們的管理團隊，再次感謝大家今天加入我們以及您對 Penumbra 的興趣。我們期待在第一季度的電話會議上向您通報最新情況。

And this does conclude today's conference call. You may now disconnect.

這確實結束了今天的電話會議。您現在可以斷開連接。