Pulmonx Corp (LUNG) 2023 Q3 法說會逐字稿

Thank you for standing by. Welcome to the Pulmonx Third Quarter 2023 Earnings Conference Call. (Operator Instructions) As a reminder, today's conference is being recorded.

謝謝你的支持。歡迎參加 Pulmonx 2023 年第三季財報電話會議。 （操作員指示）提醒一下，今天的會議正在錄製中。

I would now like to turn the conference over to your host, Laine Morgan at the Gilmartin Group. Laine, please go ahead.

現在我想將會議交給主持人吉爾馬丁集團的萊恩摩根。萊恩，請繼續。

Thank you, operator. Good afternoon, and thank you all for participating in today's call. Joining me from Pulmonx are Glen French, President and Chief Executive Officer; and John McKune, Interim Chief Financial Officer and Vice President, Corporate Controller.

謝謝你，接線生。下午好，感謝大家參加今天的電話會議。與我一起來自 Pulmonx 的還有總裁兼執行長 Glen French；臨時財務長兼副總裁兼公司財務總監約翰‧麥庫恩 (John McKune)。

Earlier today, Pulmonx issued a press release announcing its financial results for the quarter ended September 30, 2023. A copy of the press release is available on Pulmonx's website.

今天早些時候，Pulmonx 發布了一份新聞稿，宣布其截至 2023 年 9 月 30 日的季度的財務業績。該新聞稿的副本可在 Pulmonx 的網站上取得。

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據美國《私人證券訴訟改革法案》的安全港條款制定的。1995 年。本次電話會議中包含的任何與對未來事件、結果或業績的預期或預測相關的陳述均為前瞻性陳述。

All forward-looking statements, including, without limitation, those relating to our Chief Financial Officer transition, our operating trends, commercial strategies and future financial performance, the timing and results of clinical trials, expense management, expectations for hiring, growth in our organization, market opportunity, guidance for revenue, gross margin and operating expenses, commercial expansion and product pipeline development are based upon current estimates and various assumptions.

所有前瞻性陳述，包括但不限於與我們的財務長過渡、我們的營運趨勢、商業策略和未來財務表現、臨床試驗的時間和結果、費用管理、招聘預期、我們組織的發展有關的陳述、市場機會、收入指導、毛利率和營運費用、商業擴張和產品管道開發均基於當前估計和各種假設。

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of risks and uncertainties associated with our business, please refer to Risk Factors section -- to the Risk Factors section of our filings with the Securities and Exchange Commission, including the quarterly report on Form 10-Q filed with the SEC on August 4, 2023.

這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的清單和描述，請參閱風險因素部分 - 我們向證券交易委員會提交的文件中的風險因素部分，包括向 SEC 提交的 10-Q 表季度報告2023 年8月4 日。

Also during this call, we will discuss certain non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the press release, which is posted on our Investor Relations website. These non-GAAP measures are not intended to be a substitute for our GAAP results.

此外，在本次電話會議中，我們還將討論某些非公認會計準則財務指標。我們的投資者關係網站上發布的新聞稿中提供了這些非公認會計原則財務指標與最直接可比較的公認會計原則財務指標的調節表。這些非公認會計準則衡量標準無意取代我們的公認會計準則結果。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, October 30, 2023. Pulmonx disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

本次電話會議包含時間敏感信息，僅截至今天（2023 年 10 月 30 日）直播時準確。除法律要求外，Pulmonx 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，無論是因為新資訊、未來事件還是其他原因。

And with that, I'll turn the call over to Glen.

然後我會把電話轉給格倫。

Thanks, Laine. Good afternoon, and welcome to our third quarter 2023 earnings call. Here with me is John McKune, our recently appointed Interim Chief Financial Officer, who's been a leader on our finance team as VP Corporate Controller since our IPO.

謝謝，萊恩。下午好，歡迎參加我們的 2023 年第三季財報電話會議。和我在一起的是 John McKune，我們最近任命的臨時財務官，自我們首次公開募股以來，他一直擔任我們財務團隊的領導者，擔任企業財務副總裁。

We are very pleased with our recent performance as we achieved another quarter of record revenue. In the third quarter, we delivered $17.7 million in worldwide sales, representing 31% growth over the same period of the prior year and 29% on a constant currency basis. Growth was driven primarily by record U.S. performance as we achieved $11.8 million in sales, representing 41% year-over-year growth. Outperformance in the U.S. was due to continued momentum and traction of our focused commercial strategy and also to slightly less seasonal impact than expected.

我們對最近的表現非常滿意，因為我們又實現了一個季度創紀錄的收入。第三季度，我們的全球銷售額為 1,770 萬美元，年增 31%，以固定匯率計算成長 29%。成長主要得益於美國創紀錄的業績，我們實現了 1,180 萬美元的銷售額，年增 41%。美國市場的出色表現是由於我們重點放在商業策略的持續動力和牽引力，以及季節性影響略小於預期。

Meanwhile, seasonal impacts internationally were more consistent with our expectations and historical trends. Given the strength of our business year-to-date, we are updating our full year 2023 revenue guidance to be in the range of $67 million to $68 million, up from our prior guidance of $64 million to $66 million. At the midpoint, this implies anticipated year-over-year growth of over 25%.

同時，國際上的季節性影響更符合我們的預期和歷史趨勢。鑑於我們今年迄今的業務實力，我們將 2023 年全年收入指引從先前的 6,400 萬美元至 6,600 萬美元的指引上調至 6,700 萬美元至 6,800 萬美元之間。中位數意味著預計同比增長超過 25%。

We attribute our confidence largely to the traction we are seeing with our focused commercial strategy as we had planned this strategy designed to accelerate account productivity across our already meaningful footprint has resulted in 1 more existing treating centers with optimized Zephyr Valve programs; two, new treating centers launching with a greater ability to scale; and three, increased awareness around the benefits of our treatment among COPD physicians and the many patients who stand to benefit from it.

我們的信心主要歸功於我們所看到的重點商業戰略的牽引力，因為我們計劃了這一戰略，旨在提高我們已經有意義的足跡中的客戶生產力，從而導致又一個現有的治療中心擁有優化的Zephyr Valve 計劃；第二，新的治療中心啟動，具有更大的規模化能力；第三，提高了慢性阻塞性肺病醫生和許多有望從中受益的患者對我們的治療益處的認識。

In the third quarter, average U.S. account productivity was approximately 4.7 cases per center despite anticipated summer seasonality. We attribute this largely to improvement in the number of highly experienced and efficient accounts and the cases they performed, offset by continued growth in our base of actively treating centers. As a reminder, we have measured account productivity based on the average number of cases conducted in a given quarter by our active established Zephyr Valve treating hospitals, which are those that have been performing Zephyr Valve procedures for at least 4 quarters and placed a revenue-generating order in the current quarter. While seasonal trends will drive some variability in this metric from quarter-to-quarter, on average, over time, we expect account productivity to continue to move higher into the fourth quarter and beyond.

儘管預計是夏季季節性因素，但第三季美國客戶的平均生產力約為每個中心 4.7 例。我們將這主要歸因於經驗豐富、高效的客戶數量及其執行的案件數量的增加，但被我們積極治療中心基地的持續增長所抵消。提醒一下，我們根據我們活躍的 Zephyr Valve 治療醫院在給定季度內進行的平均病例數來衡量帳戶生產力，這些醫院是那些已經執行 Zephyr Valve 手術至少 4 個季度並產生收入的醫院本季度產生訂單。雖然季節性趨勢將導致該指標逐季度出現一些變化，但平均而言，隨著時間的推移，我們預計帳戶生產力將在第四季度及以後繼續提高。

Meanwhile, U.S. account activity in the third quarter of 2023 was 73%, representing 235 centers that placed a revenue-generating order in the third quarter. we continue to expect account activity to remain in the low to mid-70s range as we grow our denominator of treating centers.

同時，2023 年第三季美國帳戶活動率為 73%，即有 235 個中心在第三季下了創收訂單。隨著我們治療中心分母的增加，我們仍然預期帳戶活動將保持在 70 多歲的範圍內。

Lastly, we continue to expand our base of U.S. centers. We added 15 new accounts in the U.S. in the third quarter, bringing the total number of U.S. centers to 323 and we now expect to end the year having opened approximately 55 to 60 new accounts. Collectively, commercial trends year-to-date have demonstrated to us that treating centers, both established and new, are eager to adopt Zephyr Valve treatment and invest in their programs. This comes as patients and referring COPD physicians become increasingly familiar with our technology and its clinical benefits due to our ongoing education and outreach focused in geographies with optimized Zephyr programs. Taken together, we believe that, one, there is still meaningfully more room to grow within existing centers; and two, we are still early in penetrating broader patient demand.

最後，我們繼續擴大我們的美國中心基礎。第三季我們在美國增加了 15 個新帳戶，使美國中心總數達到 323 個，我們現在預計到年底將開設約 55 至 60 個新帳戶。總的來說，今年迄今為止的商業趨勢向我們表明，無論是老牌還是新建的治療中心都渴望採用 Zephyr Valve 治療並投資於他們的計畫。由於我們持續的教育和外展活動專注於優化 Zephyr 計畫的地區，患者和轉診 COPD 的醫生越來越熟悉我們的技術及其臨床益處。總而言之，我們相信，第一，現有中心仍有更大的發展空間；第二，我們在滲透更廣泛的患者需求方面仍處於早期階段。

As we look forward into 2024, we will invest in our commercial and educational capabilities to penetrate the market. We will continue to grow our base of highly trained and motivated new centers and strengthen existing centers by helping our champions explain the value of their programs and the value that they bring to the hospital system. And we will continue to share best practices on how to build advanced Zephyr Valve programs. In targeted geographies with well-developed programs, we will increase both patient outreach and education of COPD-focused health care providers with proven strategies that we can replicate and scale. Taken together, these strategies will help develop a growing base of highly capable centers with increasing penetration of the substantial opportunity in these geographies.

展望 2024 年，我們將投資於我們的商業和教育能力，以滲透市場。我們將繼續擴大我們訓練有素、積極進取的新中心基礎，並透過幫助我們的冠軍解釋其項目的價值以及它們為醫院系統帶來的價值來加強現有中心。我們將繼續分享如何建立先進的 Zephyr Valve 程式的最佳實踐。在計畫完善的目標地區，我們將透過可複製和擴展的行之有效的策略，增加對慢性阻塞性肺病醫療保健提供者的患者服務和教育。總而言之，這些策略將有助於發展越來越多的高能力中心基礎，並提高這些地區的大量機會的滲透率。

Meanwhile, we will continue to benefit from a growing body of published clinical evidence. Most recently, we were pleased to see the publication of data from a single-center retrospective analysis in Germany that published in the Journal of Respiratory Medicine. Results from the study suggested that patients who received endobronchial valve implantation experienced a reduction in severe COPD exacerbations in the 12 months following implantation as compared to the 12 months prior to treatment. This is similar to the documented reductions in severe exacerbations delivered by lung volume reduction surgery.

同時，我們將繼續受益於越來越多已發表的臨床證據。最近，我們很高興看到《呼吸醫​​學雜誌》上發表的德國單中心回顧性分析數據。研究結果表明，與治療前 12 個月相比，接受支氣管內瓣膜植入的患者在植入後 12 個月內 COPD 嚴重急性惡化。這與有記錄的肺部減容手術可減少嚴重急性惡化的情況類似。

Moving now to our international expansion plans. We are excited to have recently been approved for reimbursement for our Zephyr Valve treatment in Japan, which allows pricing that is consistent with our global average. This marks an essential step toward commercialization in Japan, starting next year with a post-market approval study of approximately 140 patients at 10 to 15 sites, which will then be followed by broader commercial expansion.

現在轉向我們的國際擴張計劃。我們很高興最近獲得日本 Zephyr Valve 療程的報銷批准，這使得定價與我們的全球平均水平一致。這標誌著日本商業化的重要一步，從明年開始，將在 10 至 15 個地點對約 140 名患者進行上市後批准研究，隨後將進行更廣泛的商業擴張。

Now turning to our clinical development pipeline. We remain on track with our AeriSeal program, which we expect will expand the addressable market for our Zephyr Valve solution for severe emphysema patients with collateral ventilation and continue to expect final data of the CONVERT 1 trial to be presented later next year. Meanwhile, we are preparing to launch our CONVERT 2 trial, which will form the basis for our U.S. AeriSeal PMA submission.

現在轉向我們的臨床開發管道。我們的AeriSeal 計劃仍按計劃進行，我們預計該計劃將擴大我們的Zephyr Valve 解決方案針對有側支通氣的嚴重肺氣腫患者的潛在市場，並繼續預計CONVERT 1 試驗的最終數據將於明年晚點時候公佈。同時，我們正準備啟動 CONVERT 2 試驗，這將構成我們向美國 AeriSeal PMA 提交的基礎。

I'll now turn the call over to John to provide more detailed review of our third quarter results. John?

我現在將把電話轉給約翰，以提供對我們第三季度業績的更詳細的審查。約翰？

Thank you, Glen, and good afternoon, everyone. Total worldwide revenue for the 3 months ended September 30, 2023, reached a new quarterly high of $17.7 million, a 31% increase from $13.5 million in the same period of the prior year and 29% on a constant currency basis. U.S. revenue in the third quarter reached a new record of $11.8 million, a 41% increase from $8.4 million during the prior year period. The growth in U.S. sales reflected continued commercial momentum and adoption of our Zephyr Valve therapy as well as less impact from seasonality compared to the prior year period.

謝謝格倫，大家下午好。截至 2023 年 9 月 30 日的三個月全球總收入達到 1,770 萬美元的季度新高，較上年同期的 1,350 萬美元增長 31%，按固定匯率計算增長 29%。第三季美國營收創下 1,180 萬美元的新紀錄，比去年同期的 840 萬美元成長 41%。美國銷售額的成長反映了持續的商業勢頭和 Zephyr Valve 療法的採用，以及與去年同期相比季節性影響較小。

International revenue in the third quarter of 2023 was $5.8 million, a 14% increase from $5.1 million during the same period last year and a 9% increase on a constant currency basis. The overall increase in international sales was driven by growth of Zephyr Valve procedure volumes. Gross margin for the third quarter of 2023 was 74% compared to 75% in the prior year period, reflecting higher inventory reserves in the quarter. We expect gross margin for the remainder of 2023 to be approximately 74%.

2023年第三季國際營收為580萬美元，較去年同期的510萬美元成長14%，以固定匯率計算成長9%。國際銷售額的整體成長是由 Zephyr Valve 手術量的成長所推動的。 2023 年第三季的毛利率為 74%，而去年同期為 75%，反映出該季庫存儲備較高。我們預計 2023 年剩餘時間的毛利率約為 74%。

Total operating expenses for the third quarter of 2023 were $28.2 million, a 17% increase from $24.1 million in the third quarter of 2022. Noncash stock-based compensation expense was $6 million in the third quarter of 2023. Excluding stock-based compensation expense, total operating expenses in the third quarter of 2023 increased 12% from the same period of the prior year. Looking ahead, we continue to expect operating expenses for the full year 2023 to fall between $112 million to $114 million, inclusive of approximately $21 million of noncash stock-based compensation expense as we take a disciplined and prudent approach to managing expenses while contributing to invest to drive growth.

2023 年第三季的總營運費用為 2,820 萬美元，比 2022 年第三季的 2,410 萬美元增加 17%。2023 年第三季非現金股票補償費用為 600 萬美元。不含股票補償費用，2023年第三季總營運費用較上年同期成長12%。展望未來，我們繼續預計2023 年全年的營運費用將下降到1.12 億美元至1.14 億美元之間，其中包括約2,100 萬美元的非現金股票補償費用，因為我們在促進投資的同時採取嚴格而審慎的方法來管理費用推動成長。

R&D expenses for the third quarter of 2023 were $4.2 million compared to $4.4 million in the same period of the prior year. The decrease was primarily attributable to lower AeriSeal program costs. Sales, general and administrative expenses for the third quarter of 2023 were $24 million compared to $19.7 million in the third quarter of 2022. The increase was attributable to continued investment in our commercial activities as well as an increase in legal and stock-based compensation expenses. Net loss for the third quarter of 2023 was $14.9 million or a loss of $0.39 per share as compared to a net loss of $14.2 million or a loss of $0.38 per share for the same period of the prior year. An average weighted share count of 38.1 million shares was used to determine loss per share for the third quarter of 2023.

2023 年第三季的研發費用為 420 萬美元，而去年同期為 440 萬美元。減少的主要原因是 AeriSeal 計劃成本降低。 2023 年第三季的銷售、一般和管理費用為 2,400 萬美元，而 2022 年第三季為 1,970 萬美元。這一增長歸因於對我們商業活動的持續投資以及法律和股票補償費用的增加。 2023 年第三季淨虧損為 1,490 萬美元，即每股虧損 0.39 美元，而去年同期淨虧損為 1,420 萬美元，即每股虧損 0.38 美元。平均加權股數為 3,810 萬股，用於確定 2023 年第三季的每股虧損。

Adjusted EBITDA loss for the third quarter of 2023 was $9 million as compared to $9.7 million in the third quarter of 2022. The year-over-year improvement demonstrates our ability to drive operating leverage. We ended September 30, 2023, with $139.8 million in cash, cash equivalents and marketable securities, a decrease of $7.9 million from the June 30, 2023, period. We continue to feel very good about the strength of our balance sheet and our pathway to cash flow breakeven.

2023 年第三季調整後 EBITDA 損失為 900 萬美元，而 2022 年第三季為 970 萬美元。年比改善顯示我們有能力提高營運槓桿。截至 2023 年 9 月 30 日，我們的現金、現金等價物及有價證券為 1.398 億美元，較 2023 年 6 月 30 日減少 790 萬美元。我們仍然對我們的資產負債表實力和實現現金流收支平衡的途徑感到非常滿意。

Finally, turning to our revenue outlook for 2023. Given our strong performance in the third quarter, we are updating our full year 2023 revenue guidance to be in the range of $67 million to $68 million, representing approximately 25% to 27% growth over 2022 and up from our prior guidance of $64 million to $66 million.

最後，轉向我們對 2023 年的營收展望。鑑於我們在第三季的強勁表現，我們將 2023 年全年營收指引更新為 6,700 萬美元至 6,800 萬美元，較 2022 年成長約 25% 至 27%從我們之前的指導值6400 萬美元增加到6600 萬美元。

I'll now turn the call back to Glen for his closing comments.

現在我將把電話轉回給格倫，聽取他的結束語。

So in summary, I am very pleased with the way that we are executing our operational plans and with the resulting record third quarter results. We are confident in our long-term value proposition as we continue to drive increasingly predictable growth. Further, we are advancing key development projects and now entering Japan and in both ways are working to materially expand our already substantial addressable market.

總而言之，我對我們執行營運計劃的方式以及由此產生的創紀錄的第三季業績感到非常滿意。隨著我們繼續推動日益可預測的成長，我們對我們的長期價值主張充滿信心。此外，我們正在推進關鍵開發項目，現在正在進入日本，並以這兩種方式努力實質擴大我們已經很大的潛在市場。

Finally, from a financial perspective, our revenue growth, strong balance sheet and healthy gross margins together provide us a clear path to cash flow breakeven.

最後，從財務角度來看，我們的收入成長、強勁的資產負債表和健康的毛利率共同為我們提供了實現現金流收支平衡的明確途徑。

With that, I'd like to thank you all for your attention, and we will now open the call for questions. Operator?

在此，我要感謝大家的關注，我們現在開始提問。操作員？

(Operator Instructions) And our first question will come from Jason Bednar of Piper Sandler.

（操作員說明）我們的第一個問題將來自 Piper Sandler 的 Jason Bednar。

Can you hear me okay?

你聽得到我說話嗎？

Yes.

是的。

Great. Congrats on the results in the quarter here, Glen. I want to go back to maybe the setup for -- as we came into third quarter from your comments 3 months ago in early August. You talked about maybe some concerns around seasonality in the third quarter, but you clearly outexecuted your plan, which is really great to see. So maybe could you help us understand where the quarter may have gone as you expected? Did you see the seasonality hit procedure volumes in maybe July and August?

偉大的。格倫，祝賀本季的業績。我想回到可能的設定——因為我們從三個月前八月初的評論中進入了第三季。您談到了第三季可能對季節性的一些擔憂，但您顯然超出了計劃的執行情況，這真的很高興看到。那麼，您能否幫助我們了解本季的進展是否符合您的預期？您是否看到季節性影響了七月和八月的手術量？

And then was the upside in the quarter and the raised guidance here today, was that simply what you saw then play out in September and October? Is that the right way to think about just how things unfolded for the quarter and really got us to where we're at today?

然後是本季的上行空間以及今天提高的指引，這就是您在 9 月和 10 月看到的情況嗎？這是思考本季的情況如何展開以及如何真正讓我們達到今天的水平的正確方法嗎？

Yes. Thanks, Jason. Yes, it was a very interesting quarter, and I remember talking to everybody sort of in early August, and July revealed a great deal of seasonality. And I think we probably signaled that when we were having those conversations. The good news is that August was not nearly as impacted as it was last year in the United States.

是的。謝謝，傑森。是的，這是一個非常有趣的季度，我記得在八月初與每個人交談過，七月揭示了很大的季節性。我認為，當我們進行這些對話時，我們可能已經發出了這個訊號。好消息是，美國 8 月受到的影響遠沒有去年那麼嚴重。

And I think one of the things that's fundamentally different as it relates to the U.S. situation this year versus last, or at least what it appears at this point, is that a good bit of that, which didn't happen in the third quarter of last year, rolled into the fourth quarter. So you had these delays, you had people coming back from vacations and many cases, they didn't get those procedures executed until into the fourth quarter. This year, in the third quarter, particularly in the U.S., though we had a delay in procedures in the early part of the quarter, they got completed later in the quarter. So I think that's the dynamic that explains the strength of this period unto itself and also how it contrasts to what we saw last year.

我認為，與今年美國局勢相比，或至少目前看來，有一個根本不同的事情是，其中很大一部分是在第三季度沒有發生的。去年，已進入第四季度。所以你遇到了這些延誤，有人從假期回來，很多情況下，他們直到第四季才執行這些程序。今年第三季度，特別是在美國，雖然我們在季度初的程序有所延遲，但在季度晚些時候就完成了。所以我認為這就是解釋這段時期本身的力量以及它與我們去年所看到的對比的動態。

Okay. And maybe if I could just come back then on maybe a real-time comment, I mean, how -- can you talk about maybe the exit rate in September or maybe what we're seeing here in early October and how that is contributing to the implied guidance here for the fourth quarter?

好的。也許如果我能回來發表即時評論，我的意思是，你能談談 9 月的退出率或我們 10 月初在這裡看到的情況以及這如何有助於第四季度的隱含指導？

Well, the -- what specifically are you -- I mean I will give you as much detail as we traditionally provide in terms of inter-quarter results. But when you're talking about the implied guidance, can you be more specific?

嗯，你具體是什麼——我的意思是，我將向你提供我們傳統上在季度間業績方面提供的盡可能多的細節。但是當你談論隱含的指導時，你能說得更具體一點嗎？

I guess I'm wondering to what extent, the momentum you had coming out of September, how that influenced what you're expecting now for the fourth quarter, because this wasn't just a typical beat and flow through the raise to the full year guide, this was a beat and then raised by even more than the beat. So yes, I don't want to speak for the rest of the Street, but I'm guessing that 4Q numbers are going to be moving higher today based on your updated guidance. So I'm trying to get a sense of how strong was that exit rate coming out of September that you were seeing in your business.

我想我想知道你從 9 月出來的勢頭在多大程度上影響了你現在對第四季度的預期，因為這不僅僅是典型的節拍和整個加薪流程年度指南，這是一個節拍，然後提高的幅度甚至超過了節拍。所以，是的，我不想代表華爾街的其他人發言，但我猜測根據您更新的指導，今天第四季的數據將會走高。因此，我試圖了解您在您的業務中看到的 9 月的退出率有多強。

Yes. No. Our increase was greater than our beat for this quarter, but I think you'll recall we had some catching up to do. So there were a number of questions in the past about making adjustments, we made them now. So in any case, I think as we look ahead, we are encouraged by the performance in the third quarter. We were sobered a little bit by the idea that we didn't get any carryover into the fourth quarter in the way that we did last year. And we have a limited number of -- if there's a significant impact on the number of shipping days in the fourth quarter as well.

是的。不。我們的增幅高於本季的預期，但我想您會記得我們還有一些工作要做。所以過去有很多關於調整的問題，我們現在做了。因此，無論如何，我認為當我們展望未來時，我們對第三季的表現感到鼓舞。我們沒有像去年那樣將任何資金結轉到第四季度，這想法讓我們清醒了一點。如果第四季的運輸天數也受到重大影響，我們的數量有限。

So we feel good about the fourth quarter. So we've always talked about that being a stronger relative quarter, but I think this third quarter performance is pushing up against that. And I think that's reflected in the overall guidance and what that implies as it relates to what we expect to do in the fourth quarter.

所以我們對第四季感覺良好。因此，我們一直在談論這是一個相對強勁的季度，但我認為第三季度的表現正在推動這一點。我認為這反映在總體指導及其含義中，因為它與我們預期在第四季度所做的事情有關。

All right. Perfect. And then one other maybe commercial-focused one from us, yes, but it will be a 2-parter, so apologies in advance. So you've got these new center additions in the U.S. You've been running well ahead of your expectations from where you started the year, which again is also really good to see. So first, are you able to support this better new account activity because the core productivity improvements have been as strong as they have been, like we're just talking about in the last question?

好的。完美的。然後是我們的另一部可能以商業為中心的一部，是的，但這將是一部兩人合作的電影，所以請提前道歉。所以你在美國增加了這些新的中心。從今年年初開始，你的表現遠遠超出了你的預期，這也是非常值得一看的。首先，您是否能夠支援這種更好的新帳戶活動，因為核心生產力的改進一直如此強勁，就像我們在上一個問題中剛剛討論的那樣？

And then second part, given the commercial improvements you've made this year and the account activation adjustments that you've made, can you talk about maybe some context around the accounts that you've onboarded this year, how they've scaled relative to the accounts that you've onboarded in 2021 or 2022? Just is there -- are you having more success in scaling these accounts because you have this new commercial program in place?

然後第二部分，考慮到您今年所做的商業改進以及您所做的帳戶激活調整，您能否談談您今年加入的帳戶的一些背景，以及它們相對規模的擴展情況您在2021 年或2022年註冊的帳號？就是這樣——你是否因為有了這個新的商業計劃而在擴大這些帳戶方面取得了更大的成功？

Yes. So with regard to the -- so first of all, the new additions are interesting. It's always great to bring these new centers on. I mean we're adding about 1 per territory per year. So we've got just -- we got 55 reps, will be 55 to 60 new accounts this year.

是的。因此，首先，新增加的內容很有趣。啟用這些新中心總是很棒的。我的意思是，我們每年每個地區增加約 1 個。所以我們有 55 位代表，今年將有 55 到 60 位新客戶。

With regard to our metrics, the addition of new -- of more greater-than-expected new accounts sort of dilutes the denominator in that regard. But with regard to our ability to absorb it, I think was what your question or comment was, this is kind of normal course activity, and we're not realizing any challenges with regard to our ability to absorb those accounts.

就我們的指標而言，增加新帳戶——超出預期的新帳戶在某種程度上稀釋了這方面的分母。但關於我們吸收它的能力，我認為這就是您的問題或評論，這是正常的課程活動，我們沒有意識到我們吸收這些帳戶的能力有任何挑戰。

Although I will say that as those accounts mature and they get to the 1-year mark and they get included into our calculations, they are dilutive. So an account -- though an account is much stronger at a year than it is at, say, 3 months, it's -- they still continue to expand. And so as the greater-than-anticipated number of new accounts roll in each quarter and to our denominator, it is dilutive to the overall number.

儘管我會說，隨著這些帳戶的成熟、達到一年期並納入我們的計算中，它們會被稀釋。因此，儘管一年的帳戶比三個月的帳戶要強得多，但它們仍然在繼續擴張。因此，隨著每個季度的新帳戶數量超出預期，就我們的分母而言，它會稀釋總數。

Now you asked about the context of accounts today versus, say, 2 or 3 years ago and how productive those accounts are. We have -- and I think we've talked about this before, materially increased the number and height of the hurdles that accounts need to clear in order to become accounts today. We've learned a lot over the last few years. And so I would say that these accounts that come on board are much better prepared.

現在，您詢問了今天的帳戶背景與兩三年前的情況相比，以及這些帳戶的效率如何。我們已經——我想我們之前已經討論過這一點，實質地增加了帳戶需要清除的障礙的數量和高度，才能成為今天的帳戶。過去幾年我們學到了很多。所以我想說，這些加入的帳戶準備得更好。

I mean an example of it is the number of steps that a treating physician needs to go through in order to even get to training. They need to identify at least 3 patients in advance of training. They come to training, they discuss those patients, they go back and they treat the patients, and then they have a 45-day review with an expert. So I would say that one of the fundamental differences in terms of folks that are coming out of training today is that they're much better, they're much further along in terms of their understanding of things.

我的意思是，一個例子是治療醫生甚至需要完成培訓才能完成的步驟數。他們需要在培訓前識別至少 3 名患者。他們來參加培訓，討論這些患者，然後回去治療患者，然後與專家進行 45 天的審查。所以我想說，今天從培訓中出來的人們的根本區別之一是，他們更好了，他們在對事物的理解方面取得了更大的進步。

Now going back to like does that translate directly into these accounts being way further along. I think it's super important to remember that there's a 6-step sort of process, and we take folks from step 1 through step 6 is what they're developing and they're clearing through gates along the way. That's a process that takes time, irrespective of how well trained the doctors are, who enter into it. So I would simply say that I wouldn't anticipate material acceleration with regard to getting an account up to speed. But we have a whole array of examples of accounts that are very material contributors after only 3 months and others that take longer to come up to speed. So there's a bit of a spectrum.

現在回到類似的情況，這是否會直接轉化為這些帳戶的進一步發展。我認為記住這一過程非常重要，有 6 個步驟，我們讓人們從第 1 步到第 6 步，這就是他們正在開發的內容，並且他們一路上正在通過大門。這是一個需要時間的過程，無論參與其中的醫生訓練有素。所以我只想說，我不會預期帳戶加速會出現實質的加速。但我們有一系列的例子，這些帳戶在短短 3 個月後就做出了非常重要的貢獻，而其他帳戶則需要更長的時間才能跟上。所以有一個範圍。

Okay. Appreciate all the color and congrats again on the quarter.

好的。欣賞所有的色彩並再次祝賀本季。

(Operator Instructions) And our next question will be coming from Rick Wise of Stifel.

（操作員說明）我們的下一個問題將來自 Stifel 的 Rick Wise。

Glen, I just want to make sure I'm understanding a couple of things if you could just expand on a little bit. The account productivity and implementation of best practice. You -- when you started your remarks, you talked about the number of accounts, you had a lot of momentum in accounts, and I think your words were with optimized Zephyr programs.

格倫，我只是想確保我理解了一些事情，如果你能詳細說明一下的話。帳戶生產力和最佳實踐的實施。當您開始講話時，您談到了帳戶數量，您在帳戶方面有很大的動力，我認為您的話是關於優化的 Zephyr 程序。

And Glen, I might the question, you rephrase it if you feel like I'm not coming out in a clear way, but I say to myself, you came -- you ended last year with 278 total active accounts, if I am looking at it correctly. Today, what percent of those accounts have optimized Zephyr programs? You follow me? And the reason I'm asking the question is to get at are the 25% of those 278 have optimized programs and, "Gosh, we've got a lot of room in a good way to keep driving greater productivity?" That's what I'm trying to get at.

格倫，我可能會問這個問題，如果你覺得我沒有以明確的方式表達出來，你可以重新表述一下，但我對自己說，你來了——如果我看的話，你去年的活躍賬戶總數為278 個正確地對待它。如今，這些帳戶中有多少百分比已優化 Zephyr 程式？你跟著我？我問這個問題的原因是為了了解這 278 個程序中的 25% 是否已經優化了程序，“天哪，我們有很大的空間以良好的方式繼續提高生產力？”這就是我想要達到的目的。

Yes. So first of all, an active account is one that's ordered in the last quarter, and the active number is in the low 70s, as we talked about 73%, 74%. So in any given quarter, 73% or 74% of our accounts are ordering. If you were to say, in any 6-month period, it will be about 85%. But in any case, the -- you said a year ago, we were at 278. I'll take your word for that. I don't know it off the top of my head. We're at 330 or something now. But the -- those are not all active accounts. That's the total number of accounts. So there's a subset of that, about 70% to 75% of those would be active accounts.

是的。首先，活躍帳戶是上個季度訂購的帳戶，活躍帳戶數量在 70 左右，正如我們所說的 73%、74%。因此，在任何特定季度，我們 73% 或 74% 的客戶都在訂購。如果你說，在任何 6 個月的時間內，這個比例大約是 85%。但無論如何，你一年前說過，我們的排名是 278。我相信你的話。我根本不知道。我們現在是 330 左右。但這些並不都是活躍帳戶。這就是帳戶總數。因此，其中有一個子集，其中大約 70% 到 75% 是活躍帳戶。

So let's say, out of 200 active accounts, probably about 25% to 30% of those are what I would consider to be truly optimized. And the reference to optimization in my earlier comments was really the geographies in which, when I was commenting on sort of our plans for 2024, it was in those geographies where we would be making broader investments and trying to get the word out to the COPD physicians and the patients themselves. So we've been talking about the need to have the accounts ready first, then the referring physicians or the COPD physicians and then activating the patients.

這麼說吧，在 200 個活躍帳戶中，我認為其中大約 25% 到 30% 可能是真正優化過的。我先前的評論中提到的優化實際上是指那些地區，當我評論我們的 2024 年計劃時，我們將在這些地區進行更廣泛的投資，並試圖向慢性阻塞性肺病 (COPD) 傳達訊息。醫生和患者本身。因此，我們一直在討論需要先準備好帳戶，然後轉診醫生或慢性阻塞性肺病醫生，然後啟動患者。

Got you. I know it's early. It's hard to resist asking about 2024, especially given the momentum we saw in the third quarter. And especially when I hear you talk so clearly and positively about more accounts, account productivity, the patient and physician outreach and education and training. I mean -- you -- I'm not so much looking for exact numerical guidance, feel free if you want to, but more, should we just assume that given all this, the outlook, the possibility, the likelihood of continuing in a kind of a 20% or better growth range, is there reasonable expectation based on everything we're hearing tonight?

明白你了。我知道現在還早我們很難抗拒詢問 2024 年的情況，尤其是考慮到我們在第三季度看到的勢頭。尤其是當我聽到您如此清晰而積極地談論更多帳戶、帳戶生產力、患者和醫生外展以及教育和培訓時。我的意思是——你——我並不是在尋找精確的數字指導，如果你願意的話，請隨意，但更重要的是，我們是否應該假設考慮到這一切，前景、可能性、繼續下去的可能性20% 或更好的成長範圍，根據我們今晚聽到的一切，是否有合理的預期？

Well, we feel really good about where our foundation is. We do have a number of things lined up and we feel good about that. But we're going to be providing you with specific guidance for 2024 in a few months here. And so we're not providing 2024 guidance. I know that a question was recently asked in one of these public forums about how we felt about next year and where people's heads were, and we continue to feel like you all are in the right place. But -- so I'm not trying -- I wouldn't want to talk that down, but I also am not in a position to be talking it up. We've got some more information. I think the fourth quarter is going to be an important data set. And we'll spend a lot of time between now and when we -- when that all comes together to provide far greater clarity on how we see 2024.

嗯，我們對我們的基礎感到非常滿意。我們確實有很多事情要做，我們對此感覺很好。但我們將在幾個月後為您提供 2024 年的具體指導。因此，我們不提供 2024 年指導。我知道最近在其中一個公共論壇上有人問了一個問題，關於我們對明年的感受以及人們的想法，我們仍然覺得你們都在正確的地方。但是——所以我沒有嘗試——我不想貶低這一點，但我也沒有能力談論它。我們得到了更多資訊。我認為第四季將是一個重要的數據集。從現在到我們將花費大量時間——當所有這些結合在一起時，我們將更清楚地了解我們如何看待 2024 年。

That's great. And it's great to see the excellent quarter.

那太棒了。很高興看到這個出色的季度。

And our next question will be coming from Larry Biegelsen of Wells Fargo.

我們的下一個問題將來自富國銀行的拉里·比格爾森。

This is Charles on for Larry. First, congrats on the nice quarter. A couple of questions here. First, just on AeriSeal. It sounds like that's on track here, fully enrolled CONVERT 1, presenting the final data next year. I guess from there, I mean, that -- then CONVERT 2 in your PMA submission, but how soon after CONVERT 1 completion do you think we can expect OUS sales?

這是查爾斯替補拉里。首先，恭喜這個美好的季度。這裡有幾個問題。首先，僅在 AeriSeal 上。聽起來一切都已步入正​​軌，CONVERT 1 已完全註冊，明年將公佈最終數據。我想從那裡開始，我的意思是，然後在您的 PMA 提交中 CONVERT 2，但是 CONVERT 1 完成後多久您認為我們可以預期 OUS 銷售？

So CONVERT 1 is -- we're just following up. So it's fully enrolled. We're following up. We've got, I think, a 1-year follow-up that we're going to put into our -- or can't remember, it might be 6 months. In any case, we're planning on presenting those data at the European Respiratory Society meeting. I think what you're alluding to is that we have a CE Mark in place already for AeriSeal and we have spoken about limited and then expanding over time, commercialization of AeriSeal in CE Mark regulated countries. Of course, CONVERT 2 is on the critical path to getting AeriSeal available in the United States. So that's a separate matter.

所以 CONVERT 1 是－我們只是跟進。所以已經全部錄取了。我們正在跟進。我想，我們有一個為期 1 年的後續行動，我們將把它納入我們的——或者不記得了，可能是 6 個月。無論如何，我們計劃在歐洲呼吸學會會議上展示這些數據。我認為您所指的是，我們已經為 AeriSeal 制定了 CE 標誌，並且我們已經談到了 AeriSeal 在 CE 標誌監管國家的有限商業化，然後隨著時間的推移不斷擴大。當然，CONVERT 2 正處於在美國推出 AeriSeal 的關鍵道路上。所以這是一個單獨的問題。

So we're going to go ahead and present those data, we'll get those published and then selectively sort of a limited launch, if you will, in various different locations. And the pacing of that will likely be informed by the rate of enrollment in European centers in CONVERT 2 because we don't want to create -- we don't want to inhibit the ability to get that study enrolled quickly because we're commercializing in the hospital next door to a clinical trial center.

因此，我們將繼續展示這些數據，我們將發布這些數據，然後選擇性地在不同的不同地點進行有限的發布（如果您願意的話）。其節奏可能取決於 CONVERT 2 歐洲中心的註冊率，因為我們不想創建 - 我們不想抑制快速註冊該研究的能力，因為我們正在商業化在醫院臨床試驗中心隔壁。

So in any case, I don't have perfect information on that. Once we get CONVERT 2 underway and begin to scale, we'll have much greater resolution on exactly when and how we will be commercializing. But we will commercialize in CE Mark countries ahead of the commercialization of AeriSeal in the U.S.

所以無論如何，我沒有這方面的完整資訊。一旦我們啟動 CONVERT 2 並開始規模化，我們將在具體何時以及如何商業化方面有更大的決策。但我們將在 AeriSeal 在美國商業化之前在 CE 標誌國家進行商業化。

Okay. And then just one follow-up. You announced recently -- so you're searching for a new CFO. Is there any update you could share on that or when the company might hope to have that search complete by?

好的。然後只有一個後續行動。您最近宣布，您正在尋找新的財務長。您是否可以就此分享任何最新消息，或者公司希望何時完成搜尋？

We -- you are correct. We are in the process of trying to sort that matter out. We are in the process -- we have undertaken that process. We're going to find the right person and I do not have specific resolution on the timing. I will tell you that Derrick had 2 extraordinarily strong lieutenants and 1 of them has stepped into the interim CFO role. John has been with us since the IPO and he's been Controller and essentially Chief Accounting Officer for 1 or 2 other companies before that, publicly traded. So we're in good shape, but nonetheless, we are moving quickly, and we will -- but we will not compromise. So I don't know exactly what the timing will be.

我們——你是對的。我們正在努力解決這個問題。我們正在這個過程中——我們已經進行了這個過程。我們將找到合適的人選，但我對時間沒有具體的決定。我告訴你，Derrick有兩位非常強大的副手，其中一位已經擔任臨時CFO。約翰自 IPO 以來一直在我們這裡工作，在此之前他曾擔任其他 1 或 2 家上市公司的財務總監和首席會計官。因此，我們的狀況良好，但儘管如此，我們正在迅速採取行動，而且我們會——但我們不會妥協。所以我不知道確切的時間是什麼。

Got it. And again, congrats on the nice quarter.

知道了。再次恭喜這個美好的季度。

Thank you.

謝謝。

Our next question is going to come from Joanne Wuensch of Citi.

我們的下一個問題將來自花旗銀行的 Joanne Wuensch。

And let me also say very nice quarter. I want to talk about Japan and with reimbursement now in place and it's starting to contribute to revenue next year, how should we think about the launch and the expenses that are needed for that launch?

我還要說一個非常好的季度。我想談談日本，現在已經有了報銷，並且它開始為明年的收入做出貢獻，我們應該如何考慮啟動以及啟動所需的費用？

Okay. I'm going to probably -- I might pull John into part of that answer. But from -- yes, so we got reimbursement. So that's awesome. We couldn't be happier. It is a monumental path to go through that process or the entire review and approval and then reimbursement process. So as predicted, by the end of this year, we said we would have it. We have it now, which is great. And what that does is it allows us to commence a post-approval trial. In every other country that I have been -- I've worked in, you do that in parallel with initial commercialization. In Japan, you do it on the path to commercialization.

好的。我可能會——我可能會把約翰拉進這個答案的一部分。但從——是的，所以我們得到了報銷。所以這太棒了。我們高興極了。經歷這個過程或整個審核和批准然後報銷過程是一條重要的道路。正如預測的那樣，到今年年底，我們說我們會得到它。我們現在有了它，這太棒了。這樣做的目的是讓我們能夠開始批准後試驗。在我去過的每一個其他國家——我工作過的地方，你都是在進行最初的商業化的同時進行的。在日本，你是在商業化的道路上做到這一點。

So literally, the first 140 patients treated will be entered into a protocol. They will be revenue generating and there'll be expenses that go along with them, but revenue generating is a nice thing. It's -- we expect our revenue per patient to be in the range of our global sort of revenue per patient number.

因此，從字面上看，前 140 名接受治療的患者將被納入治療方案。它們會產生收入，也會隨之產生費用，但產生收入是件好事。我們預計每位患者的收入將在全球每位患者的收入範圍內。

So we talk about very, very roughly $10,000 per patient. So 140 patients, about $1.4 million of revenue is expected. That's going to throw off a little cash to help pay for this commercialization. And John, I don't know if we break out our spending on Japan, but my guess is that the total cost -- incremental cost of commencing in Japan. We've already got the team in place. We've got some number of sales reps, marketing folks, general manager are already in place. So I don't know what we have incremental.

所以我們談論的是每個病人非常非常大約 10,000 美元。因此，預計有 140 名患者，收入約為 140 萬美元。這將花費一點現金來幫助支付這種商業化的費用。約翰，我不知道我們是否詳細列出了在日本的支出，但我的猜測是總成本——在日本開始的增量成本。我們已經把團隊安排到位了。我們已經有一些銷售代表、行銷人員、總經理就位。所以我不知道我們有什麼增量。

Yes, Glen, you're thinking about that the right way. We -- I'll reiterate that the patients we're treating in Japan are going to be revenue-generating patients and that the team that we have there is largely in place. Any -- their expense and any incremental expense will be factored into our 2024 guidance when we share that with you next quarter.

是的，格倫，你的想法是對的。我要重申，我們在日本治療的患者將是創收患者，而我們在那裡的團隊基本上已經到位。當我們下個季度與您分享時，他們的任何費用和任何增量費用都將納入我們的 2024 年指導中。

Our next question will be from John Young of Canaccord.

我們的下一個問題將來自 Canaccord 的 John Young。

Congrats on the quarter. Maybe to follow up on Joanne's question on Japan. How long do you anticipate it will take in all those 140 patients in the post-approval study? And do you have to wait for any follow-ups in the study before commencing the full commercialization in Japan?

恭喜本季。也許是為了跟進喬安妮關於日本的問題。您預計對所有 140 名患者進行批准後研究需要多長時間？在日本開始全面商業化之前是否需要等待研究的後續進展？

So with regard to waiting, no. My understanding is as soon as we enroll that 140th, we can -- we just don't want to see the data, but we won't be held up for 3, 6 or 12 months before we can go to a broader launch.

所以關於等待，沒有。我的理解是，一旦我們註冊了第 140 個，我們就可以——我們只是不想看到數據，但我們不會被耽擱 3、6 或 12 個月才能進行更廣泛的發布。

With regard to timing, as you probably know, clinical trials are -- tend to be back-end loaded, they take some time to get off the ground. And then they -- I think, probably half the patients come in, in the last quarter of the time that it takes to execute the trial. The good news for us is that we have -- since we had approval, we were able to go out and engage with all the sites that we need to engage with. And I think most, if not all of the treating physicians have gone through a training program. I believe we sent global thought leaders in on at least 2 occasions into Japan that provide extensive training to those physicians. So we're lining things up.

關於時間安排，您可能知道，臨床試驗往往是後端加載的，需要一些時間才能啟動。然後他們——我想，可能有一半的病人是在執行試驗的最後四分之一的時間內進來的。對我們來說，好消息是，自從我們獲得批准以來，我們能夠出去與我們需要參與的所有網站互動。我認為大多數（如果不是全部）主治醫生都接受過培訓計劃。我相信我們至少兩次派遣全球思想領袖前往日本，為這些醫生提供廣泛的培訓。所以我們正在安排事情。

We had to -- this -- we had to get finalization of the protocol before it could be presented to ethics committees and so forth. So we haven't gotten all of the logistics and so forth out of the way. But we'll be pushing forward. I would guess best case a year probably could bleed into a second year as well. And I think in the coming quarters, we'll have significantly greater resolution for the -- because as I said, these things tend to be back-end loaded. So there's going to be a point in time where we're going to have a high degree of precision on when we see that -- do that closing out.

我們必須——這個——我們必須最終確定協議，然後才能將其提交給道德委員會等。所以我們還沒有解決所有的物流等問題。但我們會繼續前進。我猜想一年最好的情況也可能延續到第二年。我認為在接下來的幾個季度，我們將有更大的分辨率——因為正如我所說，這些東西往往是後端加載的。因此，將會有一個時間點，當我們看到這一點時，我們將會有很高的精確度——做到這一點。

And then maybe just go back to some of the other questions on the optimized account base. Do you see certain types of centers, maybe like a strong academic center or a certain geography that are embracing the technology more and establishing those patient pathways. And I know you talked about clinical coordinators. Is it just a function of time? Or is it getting the interventional pulmonologist or COPD physicians to really champion there?

然後也許只是回到關於優化帳戶基礎的其他一些問題。您是否看到某些類型的中心，例如強大的學術中心或特定地理位置，正在更多地擁抱技術並建立這些患者途徑。我知道您談到了臨床協調員。它只是時間的函數嗎？還是讓介入性肺科醫師或慢性阻塞性肺病醫師真正支持這個領域？

Yes. There's -- I think that the singular -- we feel really good about the process that we're running folks through. So you can kind of push folks along, guide them through the process. As we talked about before, these centers represent 8% to 10% of the centers in the United States. And thus by definition, they're sort of committed to being in the lung space. It's not hard to get people to say they want to be -- they want to embrace best practices and so long as they're interested in doing that, it does pivot a lot off of people and process, so making sure that we're investing in the right people at the right centers who are embracing what we see as best practices are all super important.

是的。我認為這是獨一無二的，我們對我們幫助人們經歷的過程感覺非常好。所以你可以推動人們前進，引導他們完成整個過程。正如我們之前談到的，這些中心占美國中心的 8% 到 10%。因此，根據定義，它們有點致力於進入肺部空間。讓人們說他們想要成為這樣的人並不難——他們想要採用最佳實踐，只要他們有興趣這樣做，它確實會在很大程度上依賴人員和流程，因此確保我們在正確的中心投資於正確的人才，讓他們接受我們所認為的最佳實踐，這一切都非常重要。

But I mean, we -- there is no specific university hospital in a city of greater than 3 million patients or anything like that. We have really productive centers that would probably fall into 6 different buckets, places, fairly kind of the only game in town within 3 or 4 hours drive in certain parts of the Southeast and so forth that are incredibly productive referral centers where it's -- you just have a ton of patients that are in need of this, that are seeking out that kind of care.

但我的意思是，我們——在一個擁有超過 300 萬名患者的城市中沒有特定的大學醫院或類似的醫院。我們擁有非常高效的中心，可能會分為6 個不同的桶子、地點，在東南部某些地區，在3 或4 小時車程內的鎮上，這是唯一的遊戲，等等，這是非常高效的轉介中心，在那裡- 你只是有大量的病人需要這種服務，正在尋求這種護理。

We have university hospitals in major cities that are also sort of tertiary care referral centers, globally well-known treatment -- treating physicians and so forth. And there's an entire spectrum. And I think we've talked about some of these folks and some of the more constructive centers are outside of major cities where folks just don't want to drive down into the big city. And so 30, 40 miles outside of a big city, there's often a center that people will stop in and get their procedure done as opposed to driving further and into a fairly intimidating place, which is most major cities for people who aren't familiar with them.

我們在主要城市設有大學醫院，它們也是三級護理轉診中心、全球知名的治療——主治醫生等等。並且有一個完整的範圍。我想我們已經討論過其中一些人，一些更具建設性的中心位於主要城市之外，人們只是不想開車進入大城市。因此，在大城市外30、40 英里處，通常會有一個中心，人們會停下來完成手術，而不是開車更遠，進入一個相當令人生畏的地方，對於不熟悉的人來說，這是大多數大城市跟他們。

(Operator Instructions) Our next question will be coming from Alex Nowak of Craig-Hallum.

（操作員說明）我們的下一個問題將來自 Craig-Hallum 的 Alex Nowak。

Maybe expand on the sales dynamic in Europe, just what is needed to really unlock more of the potential in the region? Because you already have pretty good data over there. Is it reimbursement? Is it just more studies? Or is it really just an allocation of sale resources?

或許可以擴大歐洲的銷售動態，但真正釋放該地區更多潛力需要什麼？因為你那裡已經有很好的數據了。是報銷嗎？僅僅是更多的學習嗎？或者說這真的只是銷售資源的分配嗎？

Okay. So the -- your -- so the -- I think the biggest explanation of the relative performance in the third quarter, between international and the U.S., is the impact of seasonality. Our international sales are mostly, the 80-plus percent are in Europe. And there was a fairly typical third quarter across Europe. So I would expect the fourth quarter to be stronger. And I think this was fairly predictable.

好的。因此，我認為，國際和美國之間第三季相對錶現的最大解釋是季節性的影響。我們的銷售主要是國際銷售，80%以上是在歐洲。整個歐洲的第三季表現相當典型。所以我預計第四季會更加強勁。我認為這是可以預見的。

There is -- we've got -- we're direct in 97% of our revenue on a global basis is correct. So we're -- we have the -- and we have considerable, not only sales, but also marketing, regional marketing resources. So I think we're good from that perspective.

我們的全球收入中 97% 的直接數據是正確的。所以我們——我們擁有——而且我們不僅擁有大量的銷售資源，而且還擁有行銷、區域行銷資源。所以我認為從這個角度來看我們做得很好。

In terms of data, we've got 4 randomized controlled trials, all published. We're in the global guidelines. So it's not so much that. I think getting the word out in Europe and other countries is a bit more challenging than it is in the United States, largely because of either custom and/or law, and what is acceptable and not acceptable as it relates to direct-to-patient, direct-to-referring physician, even -- and the economic incentives for the treating physician are different.

在數據方面，我們有 4 個隨機對照試驗，兩者都已發表。我們遵守全球準則。所以並不是那麼回事。我認為在歐洲和其他國家進行宣傳比在美國更具挑戰性，這主要是因為習慣和/或法律，以及與直接面向患者相關的可接受和不可接受的內容，甚至直接轉診醫生——而且治療醫生的經濟誘因是不同的。

Where we are as it relates to executing outside the United States is we are embracing the things now that have been demonstrated to work in the United States and to the extent that we can leverage them outside the United States, we are focused on doing so. And I think probably our greatest success story OUS as it relates to that is the U.K., and it's easy to argue that in some ways, the U.K. -- the execution in the U.K. informed our strategies in the United States. So they're very much moving in the same direction, executing all of those things that they can embrace. And in the other larger countries we're sort of following the lead of the United States in terms of embracing some of these new approaches to the extent that they're allowable.

與在美國境外執行相關的情況是，我們正在接受現在已被證明在美國有效的東西，並且只要我們可以在美國境外利用它們，我們就會專注於這樣做。我認為我們最成功的故事 OUS 可能是英國，而且很容易說，在某些方面，英國——英國的執行情況影響了我們在美國的戰略。所以他們非常朝著同一個方向前進，執行他們可以接受的所有事情。在其他較大的國家，我們在某種程度上追隨美國的腳步，在允許的範圍內採用其中一些新方法。

Okay. That is helpful. And then clarification on the CONVERT studies. Other than the geographies and the size, are there any major differences in the protocols between the 2 studies? Or can you really compare CONVERT 1 to get a proxy for what CONVERT 2 should look like?

好的。這很有幫助。然後對 CONVERT 研究進行澄清。除了地理位置和規模之外，這兩項研究之間的方案是否有重大差異？或者你真的可以比較 CONVERT 1 來獲得 CONVERT 2 應該是什麼樣子的代理嗎？

With regard to -- I think the essence of your question is the latter part of that question is do we think that CONVERT 1 and the results from CONVERT 1 will give us -- will be a significant risk reducer as it relates to the variability that may or may not happen in CONVERT 2. And I think the answer is that we expect that the patients that we treat in CONVERT 2 will behave similarly to those that we treat in CONVERT 1.

關於 - 我認為你的問題的本質是問題的後半部分是我們是否認為 CONVERT 1 和 CONVERT 1 的結果會給我們帶來 - 將是一個顯著的風險降低器，因為它與可變性有關在CONVERT 2 中可能發生也可能不會發生。我認為答案是我們期望在CONVERT 2 中治療的患者的行為與我們在CONVERT 1 中治療的患者相似。

And we provided a window into some data that were disclosed at last year's European Respiratory Society meeting where the data indicated that nearly 80% of the time we tried to take a patient that was CV positive and make them CV negative, we were successful. So that was great. I would expect the CONVERT 1 data will remain in that neighborhood. And I would expect CONVERT 2 numbers to be in that general neighborhood. Experts told us that it needed to be greater than 30% to 50%. So being up around 75% to 80% is a really good place to be. So we would expect that, that neighborhood will stay in.

我們提供了一個窗口，了解去年歐洲呼吸學會會議上披露的一些數據，其中數據表明，在我們嘗試將 CV 呈陽性的患者轉為 CV 陰性的情況下，近 80% 的情況我們都是成功的。所以那太好了。我預計 CONVERT 1 資料將保留在該附近。我預計 CONVERT 2 數字會在該附近。專家告訴我們，需要大於30%到50%。因此，上漲 75% 到 80% 左右確實是一個不錯的情況。因此，我們預計該社區將繼續存在。

And then the question is -- that we also -- was also talked about last year was whether when you put valves in those patients, do they behave similarly to those that we treated across the 4 randomized controlled trials. And directionally, for sure, the answer is yes. So it's all good and encouraging. So I would expect the data that we see from CONVERT 1 to give us a good bit of confidence as to what we might see in CONVERT 2. It's not an identical study, but it should answer that question in the way I think you're asking it.

然後問題是，我們去年也討論過，當你將瓣膜植入這些患者時，他們的行為是否與我們在 4 項隨機對照試驗中治療的患者相似。從方向上來說，答案當然是肯定的。所以這一切都很好且令人鼓舞。因此，我希望我們從 CONVERT 1 中看到的數據能夠讓我們對 CONVERT 2 中可能看到的內容充滿信心。這不是一項完全相同的研究，但它應該以我認為您的方式回答這個問題問它。

And I'm showing no further questions. I would now like to turn the conference back to Glen for closing remarks.

我沒有再提出任何問題。現在我想請格倫進行閉幕致詞。

Great. Well, thank you all very much for your time. We are -- we couldn't be more pleased with the way the quarter went and the way that the plan seems to resonate, not only for us but for our customers. So I'd like to thank you all again for your time and attention and wish you a good evening.

偉大的。非常感謝大家抽出寶貴的時間。我們對本季的進展以及該計劃似乎引起共鳴的方式感到非常滿意，不僅對我們而且對我們的客戶。因此，我要再次感謝大家的時間和關注，並祝福大家有個美好的夜晚。

Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.

女士們、先生們，今天的會議到此結束。感謝您的參與。您現在可以斷開連線。