CVRx Inc (CVRX) 2022 Q4 法說會逐字稿

Good day, and welcome to the CVRx Q4 2022 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，歡迎來到 CVRx 2022 年第四季度財報電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker, Mr. Mike Vallie. Please go ahead.

我現在想將會議交給您的發言人 Mike Vallie 先生。請繼續。

Good afternoon. Thank you for joining us today for CVRx's fourth quarter and full year 2022 earnings conference call. Joining me on today's call are the company's President and Chief Executive Officer Nadim Yared; and its Chief Financial Officer Jared Oasheim.

下午好。感謝您今天加入我們參加 CVRx 第四季度和 2022 年全年收益電話會議。公司總裁兼首席執行官 Nadim Yared 和我一起參加今天的電話會議；及其首席財務官 Jared Oasheim。

The remarks today will contain forward-looking statements, including statements about financial guidance. The statements are based on plans and expectations as of today, which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the earnings release issued prior to this call and in the company's SEC filings, including the upcoming Form 10-K that will be filed with the SEC.

今天的評論將包含前瞻性陳述，包括有關財務指導的陳述。這些陳述基於截至今日的計劃和預期，可能會隨著時間的推移而發生變化。此外，由於許多風險和不確定性，包括在本次電話會議之前發布的收益發布和公司向美國證券交易委員會提交的文件中確定的風險和不確定性，實際結果可能存在重大差異，包括即將提交給美國證券交易委員會的 10-K 表格.

I would now like to turn the call over to CVRx's President and Chief Executive Officer, Nadim Yared.

我現在想把電話轉給 CVRx 的總裁兼首席執行官 Nadim Yared。

Thank you, Mike, and thanks to everyone for joining us today. I'll begin today's call by providing an overview of our fourth quarter and full-year performance, followed by an operational update, a review of our financial results by our CFO Jared Oasheim and then I will conclude with our thoughts on 2023 before turning to questions and answers.

謝謝你，邁克，感謝大家今天加入我們。在今天的電話會議開始時，我將概述我們的第四季度和全年業績，然後是運營更新，首席財務官 Jared Oasheim 對我們財務業績的審查，然後我將總結我們對 2023 年的看法，然後再轉向問題和解答。

We are very proud of everything that our team accomplished in 2022. It has been a great year for CVRx. We made progress towards all our strategic initiatives, resulting in the increased adoption and utilization of Barostim despite several macro disruptions throughout the year. This is demonstrated by the fact that our worldwide revenue increased by 72% over 2021, primarily driven by our U.S. Heart Failure business' 108% annual growth.

我們為我們的團隊在 2022 年取得的一切成就感到非常自豪。對於 CVRx 來說，這是偉大的一年。我們在所有戰略舉措方面都取得了進展，儘管全年出現了幾次宏觀中斷，但 Barostim 的採用和利用有所增加。事實證明，我們的全球收入比 2021 年增長了 72%，這主要是由我們美國心力衰竭業務 108% 的年增長率推動的。

And the year was capped by a strong fourth quarter. Our worldwide revenue for the fourth quarter was $7.2 million, an increase of 96% over the fourth quarter of 2021. Performance in the quarter was driven by the continued expansion of our U.S. sales force and contributions from our marketing initiatives, which led to an increase in U.S. active implanting centers.

今年第四季度表現強勁。我們第四季度的全球收入為 720 萬美元，比 2021 年第四季度增長 96%。本季度的業績是由我們美國銷售隊伍的持續擴張和我們營銷計劃的貢獻推動的，這導致了增長在美國活躍的植入中心。

In the U.S., our Heart Failure business generated $6.0 million, an increase of more than 121% over the fourth quarter of 2021. The increase was primarily driven by continued growth and expansion into new sales territories, new accounts and increased physician and patient awareness. When we went public, in the summer of 2021, we were in the very early stages of our commercial launch in the U.S. At the time, we expected to consistently grow this business in line with the investment in our commercial organization. We are very pleased with how this has played out with the fourth quarter being our 10th consecutive quarter of increasing U.S. Heart Failure revenue with average quarterly sequential growth in excess of 20% since the IPO.

在美國，我們的心力衰竭業務產生了 600 萬美元的收入，比 2021 年第四季度增長了 121% 以上。增長的主要原因是持續增長和擴展到新的銷售區域、新客戶以及醫生和患者意識的提高。當我們在 2021 年夏天上市時，我們正處於美國商業發布的早期階段。當時，我們希望根據對我們商業組織的投資來持續發展這項業務。我們對第四季度的結果感到非常滿意，這是我們連續第 10 個季度增加美國心力衰竭收入，自 IPO 以來平均季度連續增長超過 20%。

Now for an update on operational developments during the fourth quarter to support greater adoption and use of Barostim. Our focus areas were: one, the continued expansion of commercial infrastructure; two, innovation of our product portfolio; and three, (inaudible) the expansion of the clinical body of evidence.

現在更新第四季度的運營發展情況，以支持更多地採用和使用 Barostim。我們的重點領域是：一，商業基礎設施的持續擴張；二、我們產品組合的創新；第三，（聽不清）臨床證據的擴展。

Starting with the continued expansion of our commercial infrastructure. During the quarter, we added 3 new territories, bringing the total to 26. We are excited with the quality of sales talent we have been able to attract and look forward to continuing to build upon that quality in 2023. During the year, we generated momentum with several of our marketing programs, including our direct-to-consumer or (inaudible) DTC pilot program, our new branding campaign and patient (inaudible) irrigation programs. The DTC pilot program has been successful to date and has had a positive impact on our U.S. business. To date, we have made minimal investments in localized DTC campaigns, and we have seen more than 100 patients undergo a Barostim implant and have a robust pipeline of potential patients with interest in learning whether they are candidates for the therapy. We plan to continue to optimize these campaigns to make them more cost effective as we evaluate whether to roll them out more broadly.

從我們商業基礎設施的持續擴張開始。在本季度，我們增加了 3 個新區域，使總數達到 26 個。我們對能夠吸引的銷售人才的質量感到興奮，並期待在 2023 年繼續提高這種質量。在這一年中，我們產生了我們的幾個營銷計劃勢頭強勁，包括我們的直接面向消費者或（聽不清）DTC 試點計劃、我們的新品牌宣傳活動和患者（聽不清）灌洗計劃。迄今為止，DTC 試點計劃取得了成功，並對我們的美國業務產生了積極影響。迄今為止，我們對本地化 DTC 活動的投資極少，我們已經看到 100 多名患者接受了 Barostim 植入物，並且有大量潛在患者有興趣了解他們是否適合該療法。我們計劃在評估是否更廣泛地推廣這些活動時，繼續優化這些活動，使它們更具成本效益。

Our second area of focus is the innovation of our product portfolio. During the second half of 2022, we launched Barostim NEO2 IPG, the second generation device, which reduces the size of the IPG by 10% and extends battery life by 20%, reducing the frequency of device replacements for patients and their providers. It is remarkable how the NEO2 extends longevity while employing a smaller footprint and allows for a streamlining of the implantation procedure.

我們的第二個重點領域是產品組合的創新。 2022 年下半年，我們推出了第二代設備 Barostim NEO2 IPG，該設備將 IPG 的尺寸減小了 10%，電池壽命延長了 20%，減少了患者及其提供者更換設備的頻率。值得注意的是，NEO2 如何在使用更小的佔地面積的同時延長壽命並允許簡化植入程序。

Our third focus of area is the expansion of our clinical body of evidence. The BeAT-HF clinical trial was designed to demonstrate that Barostim provides a mortality and morbidity benefit in addition to a reduction of symptoms of heart failure in patients with reduced ejection fraction. As previously announced, we accrued the required 320th event in the trial and are working to collect and monitor all the data. As a reminder, the primary endpoint is a mortality and morbidity composite endpoint, and we have pre-specified a few potentially meaningful secondary and ancillary endpoints and analysis. These include a hierarchical win ratio analysis, a few COVID sensitivity analysis and ways to account for the severity of hospitalization.

我們的第三個重點領域是擴展我們的臨床證據。 BeAT-HF 臨床試驗旨在證明 Barostim 除了減少射血分數降低患者的心力衰竭症狀外，還能降低死亡率和發病率。正如之前宣布的那樣，我們在試驗中累積了所需的第 320 次事件，並且正在努力收集和監控所有數據。提醒一下，主要終點是死亡率和發病率複合終點，我們預先指定了一些可能有意義的次要和輔助終點和分析。其中包括分層贏率分析、一些 COVID 敏感性分析以及解釋住院嚴重程度的方法。

While we and the Steering Committee are still blinded to the results but also based on how the data collection is progressing, we now believe that we will be in a position to unblind and share the data before the end of the first quarter of 2023. Our goal for this post-market trial is to broaden Barostim's labeling. We plan to submit the totality of the evidence in our corresponding analysis to FDA when we outline the data. Please note that FDA is the ultimate decision-maker on whether to allow additional claims and new labeling for Barostim based on its own evaluation of all the available data. FDA may also seek advice from a panel of independent experts. At this point, it is difficult to plan for a specific scenario. The results may produce a conclusion that is more complex and nuanced than a straightforward binary answer.

雖然我們和指導委員會仍然對結果視而不見，但也基於數據收集的進展情況，我們現在相信我們將能夠在 2023 年第一季度末之前公佈和共享數據。我們的此次上市後試驗的目標是擴大 Barostim 的標籤範圍。我們計劃在概述數據時將相應分析中的全部證據提交給 FDA。請注意，FDA 是最終決策者，根據其對所有可用數據的評估，決定是否允許對 Barostim 進行額外的聲明和新標籤。 FDA 也可能征求獨立專家小組的意見。此時，很難針對特定場景進行規劃。結果可能會得出一個比簡單的二元答案更複雜、更微妙的結論。

In addition, we continue to make progress with BATwire, our ultrasound guided implant toolkit. In 2022, we added more sites and more patients into the clinical trial. As a reminder, we expect to complete the trial in 2024. We announced in late September that we added a veteran medical device executive, Kevin Hykes, to our Board of Directors. Kevin brings his business acumen and his decades-long experience in the field of cardiovascular implantable devices.

此外，我們繼續在 BATwire 方面取得進展，BATwire 是我們的超聲引導植入工具包。 2022年，我們增加了更多地點和更多患者進入臨床試驗。提醒一下，我們預計將在 2024 年完成試驗。我們在 9 月下旬宣布，我們在董事會中增加了一位經驗豐富的醫療器械高管 Kevin Hykes。凱文帶來了他的商業頭腦和他在心血管植入設備領域數十年的經驗。

Additionally, with the promotion of 4 leaders to the executive team, we now have 8 out of 10 of our executives promoted internally, showcasing the strength and depth of our talent bench at CVRx. In summary, we had a fantastic 2022 as we considerably expanded the adoption and application of Barostim as seen by 10 consecutive quarters of strong growth in our U.S. Heart Failure business.

此外，隨著 4 位領導者晉升到高管團隊，我們現在有十分之八的高管在內部晉升，展示了 CVRx 人才儲備的實力和深度。總而言之，我們在 2022 年表現出色，因為我們大大擴大了 Barostim 的採用和應用，從我們美國心力衰竭業務連續 10 個季度的強勁增長可以看出。

The year was topped off with a successful fourth quarter, during which we continued to push the growth of active implanting facilities in the United States, highlighting once more the benefits that Barostim can provide to both health care professionals and patients with cardiovascular disease.

這一年以第四季度的成功結束，在此期間我們繼續推動美國有源植入設施的發展，再次強調了 Barostim 可以為醫療保健專業人員和心血管疾病患者提供的好處。

I'll now turn the call over to Jared to review our financials. Jared?

我現在將電話轉給 Jared 來審查我們的財務狀況。賈里德？

Thanks, Nadim. Total revenue generated in the fourth quarter was $7.2 million, which is an increase of $3.5 million or 96%, when compared to the same period last year. Revenue generated in the U.S. was $6 million for the fourth quarter, which is an increase of 109% over the same period last year.

謝謝，納迪姆。第四季度的總收入為 720 萬美元，與去年同期相比增加了 350 萬美元或 96%。第四季度在美國產生的收入為 600 萬美元，比去年同期增長 109%。

Heart Failure revenue in the U.S. totaled $6 million in the fourth quarter on a total of 193 revenue units, up 121% as compared to $2.7 million in the same period last year on 95 revenue units. The increase was primarily driven by continued growth in the U.S. Heart Failure business as a result of the expansion into new sales territories, new accounts and increased physician and patient awareness of Barostim.

第四季度美國的心力衰竭收入總計 600 萬美元，共有 193 個收入單位，與去年同期的 95 個收入單位的 270 萬美元相比增長了 121%。這一增長主要是由美國心力衰竭業務的持續增長所推動的，這是由於擴展到新的銷售區域、新客戶以及醫生和患者對 Barostim 的認識提高所致。

At the end of the fourth quarter, we had a total of 106 active implanting centers as compared to 46 at the end of Q4 2021 and 91 at the end of Q3 2022. At the end of the fourth quarter, we had a total of 26 territories in the U.S. compared to 14 at the end of Q4 2021 and 23 at the end of Q3 2022. Revenue generated in Europe was $1.2 million in the fourth quarter, which is an increase of 49% when compared to the same period last year. Total revenue units in Europe increased from 39 in Q4 2021 to 68 in Q4 2022. The revenue increase was primarily due to the lessening impact of the COVID-19 pandemic in Europe. The number of sales territories in Europe remained consistent at 6 during Q4 2022.

截至第四季度末，我們共有 106 個活躍的植入中心，而 2021 年第四季度末為 46 個，2022 年第三季度末為 91 個。第四季度末，我們共有 26 個相比之下，2021 年第四季度末為 14 個，2022 年第三季度末為 23 個。歐洲第四季度的收入為 120 萬美元，與去年同期相比增長了 49%。歐洲的總收入單位從 2021 年第四季度的 39 個增加到 2022 年第四季度的 68 個。收入增加的主要原因是歐洲 COVID-19 大流行的影響減弱。 2022 年第四季度，歐洲的銷售區域數量保持在 6 個。

Gross profit was $5.7 million for the fourth quarter, an increase of $3 million when compared to the same period last year. Gross margin increased to 79% for the fourth quarter compared to 73% for the same period last year. Gross margin for the 3 months ended December 31, 2022, was higher due to a decrease in the cost per unit and an increase in average selling price, partially offset by a larger percentage of our revenue units coming from full systems versus battery replacements.

第四季度的毛利為 570 萬美元，比去年同期增加 300 萬美元。第四季度的毛利率從去年同期的 73% 增至 79%。截至 2022 年 12 月 31 日止 3 個月的毛利率較高，原因是單位成本下降和平均售價上漲，部分被我們來自完整系統而非電池更換的收入單位的較大百分比所抵消。

Research and development expenses were $3 million for the fourth quarter, which is an increase of 70% when compared to the same period last year. This change was primarily driven by increases in compensation expenses due to increased headcount.

第四季度研發費用為300萬美元，與去年同期相比增長了70%。這一變化主要是由於員工人數增加導致薪酬費用增加所致。

SG&A expenses were $14.1 million for the fourth quarter, which is an increase of 46% when compared to the same period last year. This was primarily driven by an increase in marketing and advertising costs associated with the commercialization of Barostim as well as higher compensation costs from increased headcount.

第四季度的 SG&A 費用為 1410 萬美元，與去年同期相比增長了 46%。這主要是由於與 Barostim 商業化相關的營銷和廣告成本增加以及員工人數增加帶來的更高補償成本。

Net loss was $10.5 million or $0.51 per share for the fourth quarter as compared to a net loss of $10.6 million or $0.52 per share for the same period last year. Net loss per share was based on approximately 20.6 million weighted average shares outstanding for the fourth quarter and approximately 20.4 million weighted average shares outstanding for the same period last year.

第四季度淨虧損為 1050 萬美元或每股 0.51 美元，而去年同期為淨虧損 1060 萬美元或每股 0.52 美元。每股淨虧損基於第四季度約 2060 萬股加權平均流通股和去年同期約 2040 萬股加權平均流通股。

At the end of the fourth quarter, cash and cash equivalents were $106.2 million. Net cash used in operating and investing activities was $10.9 million for the fourth quarter compared to $7.6 million for the same period last year. We continue to believe we have enough cash on hand to reach cash flow breakeven without needing to raise additional capital.

第四季度末，現金及現金等價物為 1.062 億美元。第四季度用於經營和投資活動的淨現金為 1090 萬美元，而去年同期為 760 萬美元。我們仍然相信我們手頭有足夠的現金來實現現金流盈虧平衡，而無需籌集額外資金。

Now turning to guidance. As announced in early January, for the full year of 2023, we expect total revenue between $35 million and $38 million, gross margin between 78% and 79% and operating expenses between $76 million and $80 million. For the first quarter of 2023, we expect to report total revenue between $7.1 million and $7.5 million.

現在轉向指導。正如 1 月初宣布的那樣，我們預計 2023 年全年總收入在 3500 萬美元至 3800 萬美元之間，毛利率在 78% 至 79% 之間，運營費用在 7600 萬美元至 8000 萬美元之間。對於 2023 年第一季度，我們預計報告的總收入將在 710 萬美元至 750 萬美元之間。

I would now like to turn the call back over to Nadim.

我現在想把電話轉回 Nadim。

Thanks, Jared. Before opening the line for questions, I would like to discuss our key areas of focus for 2023 as we seek to drive the increased adoption and utilization of Barostim.

謝謝，賈里德。在開始提問之前，我想討論一下我們在 2023 年的重點關注領域，因為我們力求推動 Barostim 的採用和利用。

First, the continued expansion of our commercial infrastructure, especially our direct sales force in the United States remains a top priority. We expect to continue hiring top talent throughout the year and are targeting a total of approximately 38 U.S. territories by the end of 2023 or on average, adding 3 new territories per quarter. In addition, we will continue to invest in marketing efforts to help drive increased awareness of Barostim.

首先，繼續擴大我們的商業基礎設施，尤其是我們在美國的直銷隊伍，仍然是重中之重。我們預計全年將繼續招聘頂尖人才，目標是到 2023 年底或平均每季度增加 3 個新地區，總共約 38 個美國地區。此外，我們將繼續投資於營銷工作，以幫助提高 Barostim 的知名度。

Outside of the U.S., we have added additional talent to our direct sales organization in Germany, and we continue to expect to add incremental headcount in 2023 to support our commercial strategy in that region.

在美國以外，我們為德國的直銷組織增加了更多人才，我們繼續期望在 2023 年增加員工人數，以支持我們在該地區的商業戰略。

Our second focus area is the expansion of our clinical body of evidence, both our post-market study of BeAT-HF and BATwire remain on track with our previous updates. In regard to BeAT-HF, we have been conducting this trial since early 2016. And here we are, 7 years later, we are looking forward to potentially unblinding the data and sharing the results with you before the end of this quarter.

我們的第二個重點領域是擴大我們的臨床證據，我們對 BeAT-HF 和 BATwire 的上市後研究都與我們之前的更新保持一致。關於 BeAT-HF，我們自 2016 年初以來一直在進行這項試驗。現在，7 年後，我們期待在本季度末之前可能揭盲數據並與您分享結果。

Looking ahead to 2023, we are very eager to accelerate the development of Barostim by utilizing the positive momentum we have built over the previous 2 years. While we are still very early in the commercial ramp and the market penetration, we are totally focused on the significant potential to provide treatment to as many patients as possible.

展望2023年，我們非常渴望利用過去兩年積累的積極勢頭，加速Barostim的發展。雖然我們在商業化和市場滲透方面仍處於早期階段，但我們完全專注於為盡可能多的患者提供治療的巨大潛力。

And now I would like to open the line for questions. Operator?

現在我想打開問題熱線。操作員？

(Operator Instructions) Our first question will come from the line of Robbie Marcus with JPMorgan.

（操作員說明）我們的第一個問題將來自摩根大通的 Robbie Marcus。

Maybe first, the cash burn is going to be -- it looks maybe a bit higher than last year based on the sales and OpEx guidance. And you talk about a pathway to profitability without further capital raises. How important is a positive readout from BeAT-HF (inaudible) to getting to that target? And any timeframes in terms of revenue or years out that we could be thinking about cash flow profitability?

也許首先，現金消耗將會——根據銷售和運營支出指導，它看起來可能比去年高一點。你談到了無需進一步融資即可實現盈利的途徑。 BeAT-HF 的正讀數（聽不清）對達到該目標有多重要？以及我們可以考慮現金流盈利能力的收入或年限的任何時間框架？

Yes, Robbie, thanks for the question. So one thing that we've been consistent on is the model that we've built is under the assumption that we get a neutral readout from the morbidity mortality trial. And that's not based on us being pessimistic about the results. It's just us taking a conservative approach. And so when we say that we think we still have enough cash on hand to reach cash flow breakeven, it comes with that assumption that morbidity mortality is neutral. We haven't yet drawn a line in the sand for when -- publicly, when we're going to reach that cash flow breakeven point from a run rate perspective. But we do expect this to be the year where we see that cash burn start to flatline, to be similar where -- to the burn that we saw in 2022. And then from there, starting to see the overall burn start to drop on a quarterly basis.

是的，羅比，謝謝你的提問。因此，我們一直堅持的一件事是，我們建立的模型假設我們從發病率死亡率試驗中獲得中性讀數。這並不是基於我們對結果的悲觀態度。只是我們採取了保守的做法。因此，當我們說我們認為我們手頭仍有足夠的現金來實現現金流盈虧平衡時，它伴隨著發病死亡率是中性的假設。我們還沒有在公開場合劃清界線，從運行率的角度來看，我們什麼時候才能達到現金流盈虧平衡點。但我們確實預計今年將是我們看到現金消耗開始趨於平穩的一年，與我們在 2022 年看到的燒錢相似。然後從那裡開始，整體燒錢開始下降每季。

If I just want to dream big and say it is a positive trial. How important has -- or how big a barrier has not having a mortality benefit been to driving physician adoption? And if it does have a positive, do you think we should be thinking more like a rapid improvement in adoption following? Or is there still -- would it have to wait for FDA labeling, so maybe a little time afterwards?

如果我只是想夢想成真並說這是一個積極的嘗試。沒有降低死亡率對推動醫生採用有多重要或有多大障礙？如果它確實有積極意義，您認為我們是否應該更多地考慮採用率的快速提高？或者是否還有 - 它是否必須等待 FDA 標籤，所以也許再過一段時間？

Hi, Robbie, Nadim here. So thanks for the question, by the way. Listen, when we started this trial in 2017 in it (inaudible) and 2016 started enrolling it, we powered it to win it, right? So we're still hopeful that the data will be (inaudible) a clear-cut simple yes answer to all of the questions below. That said, it's the certainty here is the time it takes to get the word out. First, we'll probably -- if there is a meeting, we'll do the announcement of the results during the medical meeting. But if there isn't one close by in terms of time (inaudible) to sit on the data for too long. So we'd like to get it out as soon as possible. So we may end up doing basically an (inaudible) event where we'll invite you and other people who wants to listen in and we'll present ourselves the data. But that does still get (inaudible). So we'll have to wait for that medical meeting and do the presentation there via symposia (inaudible) or late baker. After that, you (inaudible) alerts. One is the FDA labeling that would allow us to market the data. And the second is the publication of the (inaudible). Surprisingly, FDA has been faster than most journals. The median time to publish a manuscript (inaudible). So those are the uncertain element that would make me hesitate to say, yes, we will see a pick up in 2023, (inaudible) whether backup in sales would happen in 2024. But based on your previous question, if the data is positive, we may decide to faster (inaudible) so paradoxically, we may burn cash a little bit faster earlier to follow that. (inaudible) You have to feel that.

嗨，羅比，這裡是納迪姆。順便說一下，謝謝你的提問。聽著，當我們在 2017 年開始這項試驗（聽不清）並且 2016 年開始註冊它時，我們推動它贏得了它，對吧？因此，我們仍然希望數據將（聽不清）對以下所有問題做出明確簡單的肯定回答。就是說，這裡可以肯定的是，它需要時間來宣傳。首先，我們可能會——如果有會議，我們將在醫療會議期間宣布結果。但是，如果沒有人在時間（聽不清）上停留太久的數據。所以我們想盡快把它弄出來。所以我們可能最終會做一個（聽不清）活動，我們會邀請您和其他想要收聽的人，我們會向自己展示數據。但這仍然會（聽不清）。因此，我們將不得不等待那個醫學會議，並通過座談會（聽不清）或遲到的麵包師在那裡做演示。之後，您（聽不清）發出警報。一個是 FDA 標籤，這將使我們能夠銷售數據。第二個是（聽不清）的發布。令人驚訝的是，FDA 的速度比大多數期刊都要快。發表手稿的平均時間（聽不清）。因此，這些不確定因素讓我猶豫要不要說，是的，我們將在 2023 年看到回升，（聽不清）銷售量是否會在 2024 年出現回升。但是根據你之前的問題，如果數據是積極的，我們可能會決定更快（聽不清），所以矛盾的是，我們可能會更快地燃燒現金以遵循這一點。 （聽不清）你必須感受到這一點。

Just last quick one for me. Is this something you're going to try and submit for a late breaker at ACC or do you think you'll miss the date there?

對我來說只是最後一個快速的。這是您要嘗試提交給 ACC 的遲到者的東西，還是您認為您會錯過那裡的約會？

Yes. Thanks for the question. We don't know yet. Thank you. The (inaudible) if you're still listening, the ACC deadline for late vehicle was -- has passed. And that's why we don't know. We don't know if the data will be ready (inaudible) unblinded, number one. And if we are, if they would accept us even after the deadline. Thank you, Robbie. Operator?

是的。謝謝你的問題。我們還不知道。謝謝。 （聽不清）如果你還在聽，遲到車輛的 ACC 截止日期已經過去了。這就是我們不知道的原因。我們不知道數據是否準備好（聽不清），第一。如果我們是，他們是否會在截止日期之後接受我們。謝謝你，羅比。操作員？

And that will come from the line of Matthew O'Brien with Piper Sandler.

這將來自 Matthew O'Brien 和 Piper Sandler 的系列。

I don't know Nadim or Jared, which one of you this is for, but -- and I don't want to overstate this too much. But when I look at the unit number in Q4 versus the number of active centers that you had the last in Q3 and even in Q2, that productivity rate is down somewhat here in Q4. So can you just talk a little bit about why that's the case? And then the confidence in why those metrics improved so steadily, especially even in Q1 and all the way throughout 2023?

我不知道 Nadim 或 Jared，這是給你們中的哪一個，但是——我不想過分誇大這一點。但是當我看一下第四季度的單位數量與第三季度甚至第二季度最後一個活躍中心的數量相比，第四季度的生產率有所下降。那麼你能談談為什麼會這樣嗎？然後是對為什麼這些指標如此穩步改善的信心，尤其是在第一季度和整個 2023 年？

Matt, this is Jared. I can take that one. So as we look to the productivity for the accounts that we saw throughout 2022, part of this was driven by the success on the addition of new accounts driving the overall average productivity down. We've said early on that the -- right when an account starts, we see them treat 1 or 2 patients and then they push pause for a period of 3, 4, 5 or 6 months. They check out the results from a reimbursement perspective, but then also as to how the therapy is going with -- or doing with their patients. After they see that, then they start to pick up the pace on their own productivity. So the longer they're with us, on average, the more patients they are treating. So we still have confidence that the longer these accounts stay with CVRx, they're going to treat more and more patients based on the data that we've seen and collected over the last 3 years. But I think the challenge we're facing over the last couple of quarters is that we've exceeded expectations on the number of accounts we were expecting to add, which just drives that overall productivity rate down because of the newness of those new accounts.

馬特，這是賈里德。我可以拿那個。因此，當我們審視整個 2022 年我們看到的客戶的生產率時，部分原因是新客戶的成功增加導致整體平均生產率下降。我們早就說過——當一個賬戶開始時，我們看到他們治療 1 或 2 名患者，然後他們暫停 3、4、5 或 6 個月的時間。他們從報銷的角度檢查結果，然後還檢查治療的進展情況——或者與他們的病人一起做。在他們看到這一點之後，他們就會開始加快自己的工作效率。因此，平均而言，他們與我們在一起的時間越長，他們治療的患者就越多。因此，我們仍然有信心，這些帳戶在 CVRx 中停留的時間越長，他們將根據我們在過去 3 年中看到和收集的數據治療越來越多的患者。但我認為我們在過去幾個季度面臨的挑戰是，我們已經超出了我們預期添加的帳戶數量的預期，這只會因為這些新帳戶的新穎性而導致整體生產率下降。

So just to put a finer point on it, just because you were up 15 to 20 active centers in Q2 and Q3, respectively, that's the reason why that metric is down a little bit. And you're not seeing any change from trend line as far as utilization among those accounts as we're kind of exiting that 6-month window.

因此，為了更好地說明這一點，僅僅因為您在第二季度和第三季度分別增加了 15 到 20 個活躍中心，這就是該指標略有下降的原因。就這些帳戶的利用率而言，您沒有看到趨勢線有任何變化，因為我們正在退出 6 個月的窗口。

Yes, that's correct. Yes. We're still seeing the centers that have been with us for a couple of years, doing more than the centers that have been with us between 1 and 2 years, and they're doing more than the centers that have been with us less than 12 months.

對，那是正確的。是的。我們仍然看到與我們一起工作了幾年的中心，比與我們在一起 1 到 2 年的中心做的更多，而且他們比與我們在一起不到 1 年的中心做的更多12個月。

And then we can get into margins and all the other stuff, which are positive updates, I guess, later. But the other question I did have was really on the (inaudible) DTC campaign. It seems like there's a lot of patients out there. And I know it's just a pilot study, but what are you seeing as far as running some of those studies getting in front of patients that could be good candidates for this and then transitioning them all the way through to potentially getting an implant.

然後我們可以進入利潤率和所有其他東西，我想這些都是積極的更新。但我確實有另一個問題是關於（聽不清）DTC 活動。好像那裡有很多病人。我知道這只是一項試點研究，但就運行這些研究中的一些而言，你看到了什麼？這些研究是在患者面前進行的，這些研究可能是很好的候選者，然後將他們一直過渡到可能獲得植入物。

Matt, this is Nadim. Thanks for the question (inaudible) at our DTC pilot and why we kept it as a pilot still for a little bit longer is to understand exactly those questions that you're asking. (inaudible) need to have no idea what form of heart failure they have. If they have an ICD or a CRT they think they have a pace vehicle. And over general (inaudible). It's a disease that's harder to characterize. And when you look at our incidence rates that we calculated, you may (inaudible) 1,000 new patients every year, that's about 4% to 5% of the heart failure patients overall. So it's a small percent of standard base -- it's a game of numbers, and we track every single click, every single patient when they provide us the information we try to get as much as possible medical condition as much as we are allowed to know. And if they are seeing their own physicians versus seeing (inaudible) a past diverge and if the hospital specialist they're seeing happen to be on a site where we are already activated, as well as there (inaudible) and then it will go much faster on the other hand, much slower. So it's all of those uncertainties, Matt, that keeps us for the time being as a very (inaudible) nationwide across all centers.

馬特，這是納迪姆。感謝我們的 DTC 試點提出的問題（聽不清），以及為什麼我們將其作為試點保持更長的時間是為了準確理解您提出的那些問題。 （聽不清）需要不知道他們有什麼形式的心力衰竭。如果他們有 ICD 或 CRT，他們就會認為他們有起搏器。並且過於籠統（聽不清）。這是一種更難表徵的疾病。當您查看我們計算的發病率時，您可能（聽不清）每年有 1,000 名新患者，這大約佔心力衰竭患者總數的 4% 到 5%。所以它只是標準基礎的一小部分——這是一個數字遊戲，我們跟踪每一次點擊，每一個病人，當他們向我們提供信息時，我們試圖盡可能多地了解我們被允許知道的醫療狀況.如果他們看到自己的醫生與看到（聽不清）過去的分歧，如果他們看到的醫院專家恰好在我們已經激活的網站上，以及那裡（聽不清），那麼它會走得更遠另一方面更快，更慢。因此，正是所有這些不確定性，馬特，讓我們暫時成為一個非常（聽不清）全國所有中心的人。

Our next question -- and that will come from the line of Margaret Kaczor with William Blair.

我們的下一個問題——這將來自 Margaret Kaczor 和 William Blair 的台詞。

Just because BeAT-HF obviously (inaudible) the short-term catalyst. I was just curious if you can walk us through any commercial or marketing changes that you would make based on, let's call it, 3 scenarios where the first is positive on morbidity, mortality or on all events, maybe in more gray area of numerical improvement in mortality, but not on events and then third is maybe a less good morbidity outcome or whatever gray area that would be less good that you would look at. How would that change your behavior, I guess, relative to the guidance that you have?

只是因為 BeAT-HF 顯然（聽不清）是短期催化劑。我只是很好奇，您是否可以向我們介紹您將根據（我們稱之為）3 種情況做出的任何商業或營銷變化，其中第一種情況對發病率、死亡率或所有事件都是積極的，也許在數字改進的更多灰色區域在死亡率方面，但不是在事件方面，然後第三個可能是不太好的發病率結果，或者任何你會看到的不太好的灰色區域。我猜，相對於你所擁有的指導，這將如何改變你的行為？

Thank you, Margaret. Thanks for the question. Listen, of the 3 scenarios that you mentioned, let's start from the most negative to the most positive. The most negative, the data is neutral, there is no data (inaudible) probably what we're doing. Our plan is built on that scenario. As Jared just mentioned earlier, it's not that we don't believe that we will win. It's just -- you know what (inaudible) but would like to establish a baseline that is conservative and consider all of the positive news as upside. If it's the positive trending positive, but not meeting the endpoint itself, then probably there'll be no change in our (inaudible) the sales strategy. Now if it's a clear cut partner where we met the mortality morbidity endpoint and that (inaudible) that FDA will give us the labeling that this device improves heart failures outcome, then (inaudible) that Jared and I with the approval of our Board, we may decide to accelerate the (inaudible) in our sales and marketing efforts in the United States. And when that would happen, it will take time. You don't see (inaudible) us adding territories, you have to identify the talent, hire them, train them and so forth. So that trend will accelerate, but you will not see it overnight. (inaudible) your question?

謝謝你，瑪格麗特。謝謝你的問題。聽著，在你提到的 3 種情況中，讓我們從最消極的到最積極的開始。最負面的是，數據是中性的，沒有數據（聽不清）可能是我們正在做的。我們的計劃是建立在那個場景之上的。正如賈里德剛才提到的，我們並不是不相信我們會贏。它只是 - 你知道什麼（聽不清）但想建立一個保守的基線並將所有積極消息視為上行空間。如果它是積極的趨勢，但沒有達到終點本身，那麼我們的（聽不清）銷售策略可能不會改變。現在，如果它是一個明確的合作夥伴，我們達到了死亡率發病率終點，並且（聽不清）FDA 將給我們貼上該設備改善心力衰竭結果的標籤，那麼（聽不清）Jared 和我在我們董事會的批准下，我們可能會決定加快（聽不清）我們在美國的銷售和營銷工作。而當這種情況發生時，需要時間。你看不到（聽不清）我們增加了地區，你必須確定人才、僱用他們、培訓他們等等。所以這種趨勢會加速，但你不會在一夜之間看到它。 （聽不清）你的問題？

And then I guess, (inaudible) parting further on that, right? So the existing accounts who already have a good sense of training and patient use and history with Barostim, have you talked to them about what their expectations are for the trial and how they might change their utilization once the data is announced and also (inaudible) make one more and walk us through how they would view their (inaudible) TAM opportunity changing should one of those more positive scenarios come up?

然後我想，（聽不清）進一步分開，對吧？因此，已經對 Barostim 的培訓和患者使用以及歷史有很好了解的現有客戶，您是否與他們討論過他們對試驗的期望，以及一旦數據公佈後他們可能會如何改變他們的利用率以及（聽不清）再做一個並向我們介紹他們如何看待他們的（聽不清）TAM 機會變化，如果出現更積極的情況之一？

(inaudible) question. And now I wonder if I should have spoken with some positions about this. Number one, we instruct our sales force to be super careful and stick with (inaudible) FDA-approved labeling. So that's why they do not engage in speculative discussions regarding outcome. However, I could do that, explore that comment, getting feedback perspective. That said, there is one area where our TAM will increase if we hit the endpoint. When we negotiated the current labeling with FDA back in 2019, FDA was very clear that we have not met yet the mortality morbidity base because it was not what we are blinded for. And (inaudible) devices, when they are a Class I indicated. So (inaudible) and the presence of a left bundle (inaudible) they have the mortality morbidity benefit. FDA did not want physicians to prescribe a (inaudible) in those situations. So that's why in our calculation of the total addressable market, we excluded patients who are eligible or actually indicated for a CRT treatment. I believe that if we hit the mortality morbidity end point I know that we will ask FDA to remove that exclusion. And I believe that FDA will accept the exclusion because we should then let the physicians decide what therapy is more appropriate for their patients and the labeling would allow us then (inaudible) for those patients who are indicated for a CRT device. So that will increase the total addressable market (inaudible) to expand of how much, Margaret. But at the right time, probably during the discussion about the results we -- I'm speculating here, but I believe we'll be ready with the updated numbers of the total addressable market at the same time.

（聽不清）問題。現在我想知道我是否應該就此發表一些立場。第一，我們指示我們的銷售人員要非常小心並堅持使用（聽不清）FDA 批准的標籤。所以這就是為什麼他們不參與有關結果的推測性討論。但是，我可以這樣做，探索該評論，獲得反饋觀點。也就是說，如果我們達到終點，我們的 TAM 將在一個區域增加。當我們在 2019 年與 FDA 就當前標籤進行談判時，FDA 非常清楚我們還沒有達到死亡率發病率基礎，因為這不是我們所盲目的。和（聽不清）設備，當它們是 I 類時。因此（聽不清）和左束的存在（聽不清）它們具有死亡率發病率優勢。 FDA 不希望醫生在這些情況下開處方（聽不清）。因此，這就是為什麼在我們計算總目標市場時，我們排除了符合條件或實際表明接受 CRT 治療的患者。我相信，如果我們達到死亡率發病率終點，我知道我們將要求 FDA 取消該排除。我相信 FDA 會接受排除，因為我們應該讓醫生決定哪種療法更適合他們的患者，然後標籤將允許我們（聽不清）用於那些適用於 CRT 設備的患者。因此，瑪格麗特，這將增加總的潛在市場（聽不清）以擴大多少。但在適當的時候，可能是在討論結果的時候——我在這裡推測，但我相信我們會同時準備好更新的總目標市場數量。

Our next question. That will come from the line of William Plovanic with Canaccord.

我們的下一個問題。這將來自 William Plovanic 與 Canaccord 的血統。

A lot of them have already been answered, so I think I'll stick with some guidance and P&L stuff. As you talked, you gave us the (inaudible) rep cadence you expect in terms of the new account cadence, would you expect that to stay the same? Or are you shifting more to a go deep strategy?

其中很多已經得到解答，所以我想我會堅持一些指導和 P&L 的東西。正如你所說，你給了我們你在新客戶節奏方面所期望的（聽不清）代表節奏，你希望它保持不變嗎？還是您正在轉向更深入的策略？

Bill, this is Jared. I can handle that one. So from an account perspective, last year, we were talking about adding high single digits on a quarterly basis throughout 2022. This year, we're expecting that to be in the range of about 10 to 12 new active implanting centers added on a quarterly basis as we march through 2023. And then there is going to be a bit of work done by the account managers to really start digging a little bit deeper and work in the referral pathway for those centers that are already active. So the centers that have been around for 12 or 24 months, trying to go a little bit deeper, reach out to more of the referral cardiologists along the way.

比爾，這是賈里德。我可以處理那個。因此，從客戶的角度來看，去年，我們討論了在整個 2022 年每個季度增加高個位數的數字。今年，我們預計每個季度將增加大約 10 到 12 個新的活躍植入中心在我們邁向 2023 年的基礎上。然後客戶經理將做一些工作，真正開始更深入地挖掘，並在那些已經活躍的中心的推薦途徑中工作。因此，已經存在 12 或 24 個月的中心試圖更深入一點，在此過程中接觸到更多的轉診心髒病專家。

Okay. And that kind of -- that ties into the DTC question. And I think you kind of alluded to the fact, and I want to make sure I heard that right. Is this more of an efficiency in terms of spend that you're trying to titrate and find out what is the most efficient in terms of getting a patient and converting them all -- or getting a lead and converting it through a patient? Is that where a lot of the focus on the DTC is today?

好的。那種 - 這與 DTC 問題有關。我想你有點暗示了這個事實，我想確保我沒聽錯。這是否更像是一種支出方面的效率，您正在嘗試滴定並找出在獲得患者並將他們全部轉化方面最有效的方法 - 或者獲得潛在客戶並通過患者轉化它？這就是今天對 DTC 的很多關注點嗎？

Bill, the study by the way. Thank you for this question. It's an excellent question. Yes. direct-to-consumer awareness campaigns that medical device companies did 20 years ago are very different from what we are doing today. Think about it, what they did back then, putting TV ads was an open-loop system. What we are doing is a closed system. We favor channels where we have traceability of every single click in every single patient. And then everything (inaudible) sale ads and convert it. So we know all of those metrics at every single stage of the game. And the visible tip of the iceberg is the marketing campaign itself. 90% of the work is what happened behind the scene, those consumers who saw the ad all the way to becoming candidates -- or not becoming, to identifying if they are a candidate (inaudible) to basically offer them possibilities and contact sites that are doing the procedure. The cost for every single one of those campaigns is very closely tracked and monitored almost on a daily basis, and we (inaudible) to optimize. We are not in the business right now of throwing money and creating awareness. This is not what we're doing. We're paying money, where we believe that those money would lead to X number of patients, who are -- and that equation should be profitable for us from the (inaudible) end market. So that's what we're trying to explore. As an example, we added a new channel 2 days ago. And we'll be testing it for a few weeks, (inaudible) different iteration and see if it's as profitable, more profitable or less profitable than other channels we're using. And that's namely (inaudible) came what we're trying to do here and trying to figure out different geography, different type of sites, different type of advertisement, different channels between sort of a (inaudible) social media out there. And you do not advertise on Facebook the same way you do it on Instagram or TikTok or Twitter and so forth. So it's a big (inaudible) point of no we're so excited about.

比爾，順便學習一下。謝謝你提出這個問題。這是一個很好的問題。是的。醫療器械公司 20 年前開展的直接面向消費者的宣傳活動與我們今天開展的活動大不相同。想想看，他們當年做的，投放電視廣告，就是一個開環系統。我們正在做的是一個封閉的系統。我們喜歡可以追踪每位患者每次點擊的渠道。然後所有（聽不清）銷售廣告並將其轉換。所以我們知道遊戲每個階段的所有這些指標。可見的冰山一角是營銷活動本身。 90% 的工作是在幕後發生的事情，那些一直看到廣告的消費者成為候選人——或沒有成為候選人，確定他們是否是候選人（聽不清），基本上為他們提供可能性和聯繫網站做程序。這些活動中的每一個活動的成本幾乎每天都受到非常密切的跟踪和監控，我們（聽不清）進行優化。我們現在不從事投入資金和提高知名度的業務。這不是我們正在做的。我們正在付錢，我們相信這些錢會導致 X 數量的患者，他們是 - 這個等式應該從（聽不清）終端市場為我們帶來利潤。這就是我們要探索的。例如，我們在 2 天前添加了一個新頻道。我們將對其進行幾週的測試，（聽不清）不同的迭代，看看它是否與我們正在使用的其他渠道一樣有利可圖，更有利可圖或更不有利可圖。這就是（聽不清）我們在這裡嘗試做的事情，並試圖弄清楚不同的地理位置、不同類型的網站、不同類型的廣告、不同的渠道（聽不清）社交媒體之間的差異。而且你在 Facebook 上做廣告的方式與在 Instagram、TikTok 或 Twitter 等上做廣告的方式不同。所以這是一個很大的（聽不清）點，我們對此非常興奮。

And then quick, Jared, the $1.136 (inaudible) gain in the other, that's a little -- it's kind of a big number. Just curious what that was. And then just you've kind of went through it with Margaret, but in like as simply as possible, what would you define as positive, what would you define as neutral? And what would you define as negative for the BeAT-HF outcomes? And I know that's hard to do, but I think for investors, if you could sum it up, like where are those kind of break points? And how should we think about it?

然後很快，賈里德，另一個 1.136 美元（聽不清）的收益，這是一個很大的數字。只是好奇那是什麼。然後你就和瑪格麗特一起經歷了它，但盡可能簡單地，你將什麼定義為積極的，你將什麼定義為中立的？您將什麼定義為對 BeAT-HF 結果的負面影響？我知道這很難做到，但我認為對於投資者來說，如果你能總結一下，比如那些突破點在哪裡？我們應該如何考慮呢？

Bill, I'll just -- on the first piece of it. I mean, the biggest chunk that's fallen into that other expense net bucket is the interest income that we're seeing from the cash balance that we have at this point in time. So that's kind of the biggest number there. Nadim, I'll let you cover the second piece.

比爾，我只是 - 關於它的第一部分。我的意思是，落入其他費用淨桶中的最大部分是我們從目前的現金餘額中看到的利息收入。所以這是那裡最大的數字。 Nadim，我會讓你講第二部分。

Yes, regarding the second piece, in statistics, Bill, there is a p-value that you've identified to ensure that the trial (inaudible) kind of tie point error less than a certain percentage, right? So what FDA wants to know is what is -- whether you achieve those results as a fluke, by chance or whether the observation is (inaudible) the reality. What I consider to be positive is if the primary endpoint met the statistical relevance that FDA is looking for. I would then say it will be in between (inaudible) Margaret. If either the mortality morbidity rate is trending close to that point, but not reaching it or for what other pre-specified prioritized endpoints that we have previously agreed with FDA to analyze with (inaudible) statistical relevance. Why do I say so? Usually, when you're designing a trial for approval, you select an endpoint, if you approve the endpoint. And if you meet the endpoint, you win, if you don't meet the endpoint, you lose, and that's the end of the game. What we have seen over the past 20 years in (inaudible) devices, it's a little bit more complicated than this. And FDA has to rely on the totality of evidence before they issue a judgment on (inaudible) get approved or not. In our case, our device is already approved, the benefit outweighs the risk according to FDA. So what we're looking here is what does the device do in other elements that FDA would allow us to tell physicians that yes, the device is (inaudible). And that's why it's a little bit more complicated than the usual situation. And even if we don't meet the private end point per se, but we're (inaudible) meet another secondary or ancillary endpoint, we still believe that there is a net-net positive, not as positive as meeting the primary end point but positive above our base case right now.

是的，關於第二部分，在統計中，Bill，你已經確定了一個 p 值，以確保試驗（聽不清）類型的連接點誤差小於一定百分比，對嗎？所以 FDA 想知道的是——你取得這些結果是僥倖、偶然還是觀察結果（聽不清）是現實。我認為積極的是主要終點是否符合 FDA 正在尋找的統計相關性。然後我會說它將介於（聽不清）瑪格麗特之間。如果死亡率發病率趨勢接近該點，但未達到該點，或者我們之前與 FDA 同意使用（聽不清）統計相關性進行分析的其他預先指定的優先終點。我為什麼這麼說？通常，當您設計用於審批的試驗時，如果您批准端點，則選擇一個端點。如果你達到終點，你就贏了，如果你沒有達到終點，你就輸了，這就是遊戲的結局。過去 20 年我們在（聽不清）設備中看到的情況比這要復雜一點。 FDA 在對（聽不清）是否獲得批准做出判斷之前必須依賴全部證據。在我們的案例中，我們的設備已經獲得批准，根據 FDA 的規定，收益大於風險。所以我們在這裡看到的是該設備在 FDA 允許我們告訴醫生是的，該設備是（聽不清）的其他元素中做了什麼。這就是為什麼它比通常情況要復雜一點。即使我們本身沒有達到私人終點，但我們（聽不清）達到另一個次要或輔助終點，我們仍然相信存在淨-淨積極，而不是像達到主要終點那樣積極但現在高於我們的基本情況。

Our next question. That will come from the line of Alex Nowak with Craig-Hallum.

我們的下一個問題。這將來自 Alex Nowak 和 Craig-Hallum 的系列。

And perhaps I missed this, but can you expand on what is happening in the background, collecting all the morbidity data to move the readout from the first half to first quarter? You must be seeing something or hearing something to give you that confidence, it's going to come this quarter rather than more in the first half of the year.

也許我錯過了這一點，但您能否詳細說明背景中發生的事情，收集所有發病率數據以將讀數從上半年移至第一季度？您必須看到或聽到某些東西才能給您信心，它會在本季度出現，而不是在今年上半年出現。

Alex, this is Nadim, nice hearing from you (inaudible) it's actually not the data, but the rate of collection of the data and the rate of monitoring of the data. So we're justifying (inaudible) the trend of monitoring of sites to ensure that we will have all of the data monitored as required by FDA before we (inaudible). And based on the trajectory, we see we are able -- and we're able to narrow the time line for the unblinding (inaudible) how it's a very strong likelihood that this will happen in Q1, not in Q2.

亞歷克斯，我是納迪姆，很高興收到你的來信（聽不清）實際上不是數據，而是數據收集率和數據監控率。因此，我們正在證明（聽不清）監控站點的趨勢，以確保在我們（聽不清）之前我們將按照 FDA 的要求監控所有數據。根據軌跡，我們看到我們能夠——而且我們能夠縮小揭盲（聽不見）的時間線，這很有可能在第一季度而不是第二季度發生。

(inaudible) (cross talk) What do you think about the rate of new center adds in 2023? You more than doubled that number in 2022. I'm just going to throw it out to double the number again in 2023? Or what are you thinking about what the ramping sales can do this year?

（聽不清）（相聲）您如何看待 2023 年新中心的增加率？你在 2022 年將這個數字增加了一倍多。我只是想在 2023 年再次將這個數字增加一倍？或者你在想今年銷量的上升會帶來什麼？

Yes, Alex, maybe I'll just kind of baseline on that guidance again. So for the U.S. Heart Failure business, the midpoint of the range, the expectation is that we'll be seeing ads of around 10 to 12 active implanting centers on a quarterly basis going forward. Continuing to see those longer-term accounts continue to ramp up the productivity level similar to rates we saw in the past. And then as I just looked to the hypertension business in the U.S., it's still flat, right? It's a set patient population. And then just one more piece on the European side of it. We still haven't necessarily cracked the code over there at this point. And so our base case, the middle of the road of the guidance is that it would stay consistent at around that $1 million or so per quarter. We saw a bit of an uptick there in the fourth quarter, but some of that was distributors stocking up some shelves -- shelf units there for the first half of 2023. So we don't expect that to be repeated here in the first quarter. So overall, the vast majority of that growth coming from the U.S. Heart Failure business, but most of that revenue is coming from those centers that have already signed up, have already been activated in 2022 and then adding that $10 to $12 million per quarter going forward.

是的，亞歷克斯，也許我會再次作為該指導的基線。因此，對於美國心力衰竭業務，範圍的中點，預期我們將在未來每季度看到大約 10 到 12 個活動植入中心的廣告。繼續看到那些長期賬戶繼續提高生產率水平，類似於我們過去看到的水平。然後當我只關注美國的高血壓業務時，它仍然持平，對吧？這是一個固定的患者群體。然後在它的歐洲一側再多一塊。在這一點上，我們還不一定能破解那裡的密碼。因此，我們的基本情況，指導的中間路線是，它會保持在每季度 100 萬美元左右的水平。我們在第四季度看到了一些增長，但其中一些是分銷商囤積了一些貨架——2023 年上半年那裡的貨架單元。所以我們預計第一季度不會在這裡重複這種情況.所以總的來說，絕大多數增長來自美國心力衰竭業務，但大部分收入來自那些已經簽約的中心，這些中心已經在 2022 年啟動，然後每季度增加 10 到 1200 萬美元向前。

And maybe on my last point, what do you need to happen for Europe to really ramp? Is it just you need to put a little bit more focus on it, you're just focusing too much on the U.S. for obviously good reasons. Is it a reimbursement dynamic? Just how are you thinking about Europe?

也許關於我的最後一點，你需要做什麼才能讓歐洲真正崛起？是不是你需要更多地關注它，你只是出於明顯充分的理由過多地關注美國。是報銷動態嗎？您如何看待歐洲？

Alex, this is Nadim. It's all of the above. From a -- first, we're really not in Europe, we're in Germany and a couple of other countries. In regards to Germany, we have a (inaudible) ZE code from a reimbursement perspective. (inaudible) ZE code is kind of the middle layer. It's not a (inaudible) slowing in new it's not as good as DRG. One of the constraints about the ZE code is that the (inaudible) hospital has to (inaudible) procedures at the beginning of the year with their payers. But even if they pre-negotiated it, they could do the procedure, they can still be in after by an entity called the MDS that is made of medical auditors who would come in hindsight. And that kind of scares off (inaudible) hospitals of engaging in procedures that are not yet at DRG or are not yet in the guidelines. And we are neither. And because of this, we have not had (inaudible) in Germany right now, waiting until we have more data and do more advocacy and education in regards to getting the (inaudible) in the guidelines in Europe. And it's a chicken and the egg. To get a DRG, we need a certain number of units per year (inaudible) about 1,500 procedures. We have a device that's a high price, low number of units, as I've mentioned (inaudible) and because of that, it's harder to get 1,500 units in Germany to get into that DRG examination mode. (inaudible) all of the above that we have not yet decided to invest heavily in Europe, just in the comparison. We have more in our marketing team (inaudible) we have our entire team in Europe right now. It takes from an education perspective, physician education, patient education and direct-to-consumer marketing, the physician-directed marketing team and so forth, it's a large effort that (inaudible) resources right now to duplicate that just for Germany, in Germany, and we don't have the volume to justify being able to do it. And again, it's a chicken and the egg (inaudible) have to decide to do it and break that loop. But right now, our focus is in the U.S. Have I answered your question, Alex?

亞歷克斯，這是納迪姆。以上都是。首先，我們真的不在歐洲，我們在德國和其他幾個國家。關於德國，從報銷的角度來看，我們有一個（聽不清）ZE 代碼。 （聽不清）ZE 代碼是一種中間層。這不是新的（聽不清）減慢，它不如 DRG 好。 ZE 代碼的限制之一是（聽不清）醫院必須在年初與其付款人進行（聽不清）程序。但即使他們預先協商好，他們可以執行程序，他們仍然可以通過一個名為 MDS 的實體進行處理，該實體由事後看來會出現的醫療審計員組成。那種嚇跑（聽不清）醫院從事尚未在 DRG 或尚未在指南中的程序。而我們兩者都不是。正因為如此，我們現在在德國還沒有（聽不清），等到我們有更多的數據並進行更多的宣傳和教育以在歐洲獲得（聽不清）指南。這是先有雞還是先有蛋。要獲得 DRG，我們每年需要一定數量的單位（聽不清）大約 1,500 個程序。正如我已經提到的（聽不清），我們有一個價格高、單位數量少的設備，因此，在德國很難獲得 1,500 個單位進入 DRG 檢查模式。 （聽不清）以上所有我們還沒有決定在歐洲大量投資，只是在比較。我們的營銷團隊中有更多人（聽不清），我們現在整個團隊都在歐洲。從教育的角度來看，醫生教育、患者教育和直接面向消費者的營銷、以醫生為導向的營銷團隊等等，這是一項巨大的努力，現在（聽不清）資源只為德國複製，在德國，而且我們沒有足夠的數量來證明能夠做到這一點。再一次，這是一隻雞和雞蛋（聽不清）必須決定這樣做並打破這個循環。但現在，我們的重點是美國。亞歷克斯，我回答你的問題了嗎？

Thank you.

謝謝。

Go ahead, Operator.

來吧，接線員。

I'm showing no further questions in the queue. At this time, I would like to turn the call back over to you, Mr. Yared for any closing remarks.

我不會在隊列中顯示更多問題。在這個時候，我想把電話轉回給你，Yared 先生，請你發表任何結束語。

Excellent. Thank you so much, Operator. And thanks, everyone, again for joining us for our fourth quarter earnings call. We have (inaudible) and we look forward to updating you on our progress during our next update. Good night.

出色的。非常感謝，接線員。再次感謝大家參加我們的第四季度財報電話會議。我們已經（聽不清）並期待在下次更新時向您通報我們的進展。晚安。

Thank you all for participating. This concludes today's program. You may now disconnect.

謝謝大家的參與。今天的節目到此結束。您現在可以斷開連接。