CVRx Inc (CVRX) 2023 Q2 法說會逐字稿

Greetings, and welcome to the CVRxQ2 2023 Earnings Call. (Operator Instructions). As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Vallie. Thank you, Mike. You may begin.

您好，歡迎參加 CVRx2023 年第二季度財報電話會議。 （操作員說明）。提醒一下，本次會議正在錄製中。現在我很高興向大家介紹你們的主持人邁克·瓦利 (Mike Vallie)。謝謝你，邁克。你可以開始了。

Good afternoon. Thank you for joining us today for CVRx's Second Quarter 2023 Earnings Conference Call. Joining me on today's call are the company's President and Chief Executive Officer; and Nadim Yared; and Chief Financial Officer, 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-Q that will be filed with the SEC. I would now like to turn the call over to CBRx's President and Chief Executive Officer, Nadim Yared.

下午好。感謝您今天參加我們的 CVRx 2023 年第二季度收益電話會議。參加今天電話會議的還有該公司的總裁兼首席執行官；和納迪姆·亞里德；和首席財務官賈里德·奧西姆 (Jared Oasheim)。今天的講話將包含前瞻性陳述，包括有關財務指導的陳述。這些聲明基於截至目前的計劃和預期，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，包括本次電話會議之前發布的收益報告和公司向 SEC 提交的文件（包括即將向 SEC 提交的 10-Q 表格）中確定的風險和不確定性，實際結果可能存在重大差異。我現在想將電話轉給 CBRx 總裁兼首席執行官 Nadim Yared。

Thank you, Mike, and thanks to everyone for joining us. I'll begin today's call by providing an overview of our second quarter performance, followed by an operational update and a review of our financial results by our CFO, Jared Oasheim. Then I will conclude with our thoughts for the rest of the year before turning to Q&A. We are thrilled to share that we had another excellent quarter. The nearly 120% year-over-year growth that we delivered in the U.S. exceeded our expectations and is highlighted by the strength in volumes, the expansion of the new U.S. active implanting centers and the development of our new customer pipeline. Importantly, we are continuing to receive very positive feedback from physicians regarding their own experience when using our Barostim therapy on their patients. Our financial performance continues to demonstrate the quality of the Barostim procedure, the robust demand for Barostim in the market and our ability to execute. Now let's dive into the details of our performance during the quarter. Worldwide revenue was $9.5 million, an 89% increase over the second quarter of 2022. This was primarily due to the continued execution within our U.S. heart failure business, which grew by 119% over the prior year. These results came from the ongoing utilization of Barostim within our existing customer base, our successful expansion into new territories and the elevated physician and patient awareness. We are encouraged that following our February announcement of the preliminary results of the BeAT-HF trial, adoption and utilization of Barostim has continued to grow. In each of the 4 months following that announcement, the business has been strong and physicians have seen the data at scientific meetings have had positive reactions. Turning to an update on our operational progress during the second quarter. As a reminder, our focus areas are the continued expansion of our commercial infrastructure, and the expansion of our clinical body of evidence.

謝謝你，邁克，也感謝大家加入我們。在今天的電話會議中，我將首先概述我們第二季度的業績，然後由我們的首席財務官賈里德·奧西姆 (Jared Oasheim) 介紹運營情況更新情況以及對我們的財務業績的審查。然後我將總結我們今年剩餘時間的想法，然後再進行問答。我們很高興與大家分享，我們又度過了一個出色的季度。我們在美國實現的近 120% 的同比增長超出了我們的預期，銷量的強勁、美國新的主動植入中心的擴張以及新客戶渠道的開發凸顯了這一點。重要的是，我們不斷收到醫生關於他們在患者身上使用我們的 Barostim 療法時的體驗的非常積極的反饋。我們的財務業績繼續證明了 Barostim 程序的質量、市場對 Barostim 的強勁需求以及我們的執行能力。現在讓我們深入了解本季度業績的細節。全球收入為 950 萬美元，比 2022 年第二季度增長 89%。這主要歸功於我們美國心力衰竭業務的持續執行，該業務比上一年增長了 119%。這些結果來自於我們現有客戶群中 Barostim 的持續使用、我們成功擴展到新領域以及醫生和患者意識的提高。令我們感到鼓舞的是，繼 2 月份宣布 BeAT-HF 試驗的初步結果之後，Barostim 的採用和使用持續增長。在該公告發布後的 4 個月裡，業務一直表現強勁，醫生們也看到科學會議上的數據產生了積極的反應。接下來是我們第二季度運營進展的最新情況。提醒一下，我們的重點領域是持續擴大我們的商業基礎設施，以及擴大我們的臨床證據。

Starting with the continued expansion of our commercial infrastructure. As expected, we added three new U.S. sales territories, bringing the total to 32. The talent we have been able to attract and put into the field is impressive, and we look forward to continuing to leverage their abilities to educate and train physicians and healthcare providers on Barostim. Also during the second quarter, we further progressed our marketing initiatives, including our direct-to-consumer and patient education programs, which we will continue to optimize to support our commercial strategy. Moving to our second focus area, the expansion clinical body of evidence. As announced in June, we submitted the PMA supplement to FDA, which included data collected as part of the post-market BeAT-HF study. As a reminder, the PMA supplement is seeking a potential label expansion for Barostim, in line with the recommendation of the Executive searing committee of the BeAT-HF trial. We fully agree with the committee's assessment that the totality of evidence strongly supports Barostim as a safe and effective treatment option for heart failure. We are currently undergoing the normal review process with FDA and expect to receive a response from FDA by the end of the year. We remain committed to closely monitoring the progress and will provide updates when we have significant developments to share.

首先是我們商業基礎設施的持續擴張。正如預期的那樣，我們增加了三個新的美國銷售地區，使總數達到 32 個。我們吸引並投入該領域的人才令人印象深刻，我們期待繼續利用他們的能力來教育和培訓醫生和醫療保健Barostim 上的提供商。同樣在第二季度，我們進一步推進了營銷計劃，包括直接面向消費者和患者教育計劃，我們將繼續優化這些計劃以支持我們的商業戰略。轉向我們的第二個重點領域，擴大臨床證據。正如 6 月份宣布的那樣，我們向 FDA 提交了 PMA 補充材料，其中包括作為上市後 BeAT-HF 研究的一部分收集的數據。提醒一下，PMA 增刊正在尋求 Barostim 的潛在標籤擴展，以符合 BeAT-HF 試驗執行委員會的建議。我們完全同意委員會的評估，即所有證據都強烈支持 Barostim 作為心力衰竭的安全有效的治療選擇。我們目前正在接受 FDA 的正常審查程序，預計在今年年底前收到 FDA 的答复。我們將繼續致力於密切關注進展情況，並在有重大進展需要分享時提供最新信息。

One last update. CMS recently released the proposed outpatient prospective payment system or OPPS, for short, for 2024, along with the proposed physician fee schedule for the same period. Of particular note was the absence of any mention of our March submission requesting assignment to one of the new technology APC payment codes as our transitional pass-through additional payment expires at the end of 2023. We anticipate submitting formal comments on the proposed OPPS package and advocate for inclusion in the final document later this year. However, please remember that our base case for 2024 is the status quo, which would lead to a reduction in our expected average selling price across the U.S. to approximately $26,000. This has been the assumption in our model that is guiding us to be able to reach cash flow breakeven without the need to complete an equity financing. We are very excited about what we have been able to accomplish during the second quarter and throughout the first half of 2023. Through the first 6 months of the year, we have grown our U.S. heart failure revenue by 124% as compared to 2022. We look forward to continuing to build on this momentum for the balance of the year and I want to thank our team for their dedication to our mission of improving the lives of patients suffering from heart failure. I'll now turn the call over to Jared to review our financials. Jared?

最後更新一次。 CMS 最近發布了擬議的 2024 年門診預期支付系統（簡稱 OPPS）以及同一時期的擬議醫生費用表。特別值得注意的是，由於我們的過渡性轉通額外付款將於 2023 年底到期，因此沒有提及我們 3 月份提交的申請，要求分配新技術 APC 支付代碼之一。我們預計將就擬議的 OPPS 方案提交正式意見，並且主張將其納入今年晚些時候的最終文件中。然而，請記住，我們對 2024 年的基本預測是維持現狀，這將導致我們在美國的預期平均售價降至約 26,000 美元。這是我們模型中的假設，指導我們無需完成股權融資即可實現現金流盈虧平衡。我們對 2023 年第二季度和上半年所取得的成就感到非常興奮。今年前 6 個月，我們的美國心力衰竭收入比 2022 年增長了 124%。我們期待在今年剩下的時間裡繼續保持這一勢頭，我要感謝我們的團隊致力於改善心力衰竭患者的生活這一使命。我現在將電話轉給賈里德，讓他審查我們的財務狀況。賈里德？

Thanks, Nadim. In the second quarter, total revenue generated was $9.5 million, representing an increase of $4.5 million or 89% compared to the same period last year. Revenue generated in the U.S. was $8.3 million in the current quarter, reflecting growth of 111% over the same period last year. Heart failure revenue in the U.S. totaled $8.3 million in the current quarter on a total of 265 revenue units compared to $3.8 million in the second quarter of last year on 128 revenue units. The increases were 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. At the end of the current quarter, we had a total of 140 active implanting centers compared to 71 on June 30, 2022, and 122 on March 31, 2023. We also had 32 sales territories in the U.S. at the end of the current quarter compared to 20 on June 30, 2022, and 29 on March 31, 2023. Revenue generated in Europe was $1.2 million in the current quarter representing an increase of 10% compared to the same period last year. Total revenue units in Europe increased from 52% in Q2 of 2022 to 56 in the current quarter. The number of sales territories in Europe remained consistent at 6 for the 3 months ended June 30, 2023.

謝謝，納迪姆。第二季度總收入為950萬美元，較去年同期增加450萬美元，增幅89%。本季度在美國產生的收入為 830 萬美元，較去年同期增長 111%。本季度美國心力衰竭治療收入總計 830 萬美元，共有 265 個收入單位，而去年第二季度的收入為 380 萬美元，共有 128 個收入單位。這一增長主要是由美國心力衰竭業務的持續增長推動的，這是由於擴展到新的銷售領域、新客戶以及醫生和患者對 Barostim 認知度的提高。截至本季度末，我們共有 140 個活躍植入中心，而 2022 年 6 月 30 日為 71 個，2023 年 3 月 31 日為 122 個。截至本季度末，我們在美國還有 32 個銷售區域相比之下，2022 年 6 月 30 日為 20 日，2023 年 3 月 31 日為 29 日。本季度歐洲產生的收入為 120 萬美元，較去年同期增長 10%。歐洲的總收入單位從 2022 年第二季度的 52% 增加到本季度的 56 個。截至 2023 年 6 月 30 日的三個月，歐洲銷售地區數量保持在 6 個。

Gross profit for the 3 months ended June 30, 2023, was $8.0 million an increase of $4.2 million compared to the 3 months ended June 30, 2022. Gross margin for the current quarter increased to 84% compared to 76% for the same period last year. Gross margin for the 3 months ended June 30, 2023, improved primarily due to a decrease in the cost per unit driven by increased production volumes. Research and development expenses for the current quarter were $ 3.3 million, reflecting an increase of 39% compared to the same period last year. This change was driven by a $ 0.6 million increase in compensation expenses as a result of increased headcount, a $ 0.1 million increase in noncash stock-based compensation expense and a $ 0.1 million increase in consulting fees. SG&A expenses for the current quarter were $ 16.5 million, representing an increase of 32% compared to the same period last year. This change was primarily driven by a $2.5 million increase in compensation expenses, mainly as a result of increased headcount, a $0.8 million increase in marketing and advertising expenses associated with the commercialization of Barostim in the U.S., a $0.4 million increase in travel expenses and a $0.3 million increase in noncash stock-based compensation expense.

截至2023年6月30日止三個月的毛利潤為800萬美元，較截至2022年6月30日止三個月增加420萬美元。本季度毛利率增至84%，而上年同期毛利率為76%年。截至2023年6月30日止三個月的毛利率有所改善，主要是由於產量增加導致單位成本下降。本季度研發費用為330萬美元，較去年同期增長39%。這一變化是由於員工數量增加導致薪酬費用增加 60 萬美元、非現金股票薪酬費用增加 10 萬美元以及諮詢費用增加 10 萬美元。本季度的 SG&A 費用為 1650 萬美元，較去年同期增長 32%。這一變化主要是由於薪酬費用增加 250 萬美元（主要是由於員工數量增加）、與 Barostim 在美國商業化相關的營銷和廣告費用增加 80 萬美元、差旅費用增加 40 萬美元以及非現金股票補償費用增加 30 萬美元。

Interest expense increased $0.5 million for the 3 months ended June 30, 2023, compared to the 3 months ended June 30, 2022. This increase was driven by the interest expense on the borrowings under the loan agreement entered into on October 31, 2022. Other income net was $0.6 million in the current quarter compared to other expense net of $34,000 for the same period last year. The income in the second quarter of 2023 was primarily driven by interest income on our interest-bearing accounts. Net loss for the current quarter was $11.7 million or $ 0.56 per share compared to a net loss of $11.1 million or $0.54 per share for the same period last year. Net loss per share was based on 20.7 million weighted average shares outstanding for the second quarter of 2023 and 20.5 million weighted average shares outstanding for the second quarter of 2022. At the end of the second quarter, cash and cash equivalents were $90.8 million. Net cash used in operating and investing activities was $12.95 million for the second quarter which included our annual premium for our directors and officers insurance of approximately $2 million. This is compared to net cash used in operating and investing activities of $10.5 million for the 3 months ended March 31, 2023.

與截至2022年6月30日止3個月相比，截至2023年6月30日止3個月的利息支出增加了50萬美元。這一增長是由於2022年10月31日簽訂的貸款協議項下借款的利息支出所致。 其他本季度的淨收入為 60 萬美元，而去年同期的其他費用淨額為 34,000 美元。 2023年第二季度的收入主要由生息賬戶的利息收入驅動。本季度淨虧損為 1170 萬美元，即每股 0.56 美元，而去年同期淨虧損為 1110 萬美元，即每股 0.54 美元。每股淨虧損基於 2023 年第二季度加權平均已發行股票 2070 萬股和 2022 年第二季度加權平均已發行股票 2050 萬股計算。第二季度末，現金和現金等價物為 9080 萬美元。第二季度運營和投資活動使用的淨現金為 1,295 萬美元，其中包括我們董事和高級管理人員保險的年度保費約為 200 萬美元。相比之下，截至 2023 年 3 月 31 日的三個月，運營和投資活動使用的淨現金為 1,050 萬美元。

Now turning to guidance. For the full year of 2023, we now expect total revenue between $37.0 million and $38.5 million, up from $35.5 million to $38 million. We now expect full year gross margins between 83% and 84%, up from 80% to 83% and we now expect operating expenses between $78 million and $80 million, up from $76 million to $80 million. For the third quarter of 2023, we expect to report total revenue between $9.5 million and $10.2 million. I would now like to turn the call back over to Nadim.

現在轉向指導。我們現在預計 2023 年全年的總收入將在 3700 萬美元至 3850 萬美元之間，高於 3550 萬美元至 3800 萬美元。我們現在預計全年毛利率將在 83% 至 84% 之間，從 80% 上升至 83%；我們現在預計運營費用在 7800 萬美元至 8000 萬美元之間，從 7600 萬美元上升至 8000 萬美元。我們預計 2023 年第三季度的總收入將在 950 萬美元至 1020 萬美元之間。我現在想把電話轉回納迪姆。

Thanks, Jared. We had a fantastic first half of 2023. Our strategy for driving the adoption of Barostim while continuing to deliver improving financial performance is working. Which has resulted in increased revenue guidance for the second consecutive quarter. We are particularly pleased that the business has continued to flourish particularly since the announcement of our BeAT-HF data in February, and we remain optimistic about our plans to continue to grow. We look forward to building on our success during the back half of this year. And now I would like to open the line for questions. Operator?

謝謝，賈里德。我們在 2023 年上半年度過了美好的一年。我們推動 Barostim 的採用同時繼續改善財務業績的戰略正在發揮作用。這導致連續第二個季度增加收入指引。我們特別高興的是，該業務持續蓬勃發展，特別是自 2 月份公佈 BeAT-HF 數據以來，我們對繼續增長的計劃保持樂觀。我們期待在今年下半年取得成功。現在我想開通提問熱線。操作員？

(Operator Instructions). Our first question comes from Robbie Marcus with JP Morgan. Please proceed with your question.

（操作員說明）。我們的第一個問題來自摩根大通的羅比·馬庫斯。請繼續你的問題。

This is Allen on for Robbie. Congrats on the good quarter. Just starting with some of the momentum that you saw, through first quarter and second quarter, we really saw that translating into better active implanting centers than, I think, originally contemplated. So what are you seeing in the third quarter so far when it relates to that? And how sustainable do you think that level of more mid- to high-teens center ads will be into third quarter, fourth quarter and then beyond that?

這是艾倫替羅比發言。祝賀季度表現良好。從您看到的一些勢頭開始，通過第一季度和第二季度，我們確實看到它轉化為比我最初設想的更好的主動植入中心。那麼到目前為止，您在第三季度看到了什麼？您認為更多中高青少年中心廣告的水平將持續到第三季度、第四季度以及之後的可持續性如何？

Allen, this is Jared. I can take that one. Thanks for the question. So we've seen really strong numbers for active implanting center additions over the last few quarters. We talked about this back in 2022 as COVID moved to the wayside in hospital staffing surges were kind of solved. We started to see more interest from hospitals to get these programs off the ground. And that's allowed us to activate these centers. We remind everybody that the contracting process does take time. And therefore, we do have some insight into the pipeline of new centers that are on contract through value assessment and champions identified. And then the next step in the process to be identified as an active implanting center is to get that first patient treated. And that's where some of the hospital staffing shortage issues could come into play in the future. But I think as we look forward into Q3 and Q4 and out into 2024, we're still expecting to see about 12 to 13 new active implanting centers per quarter just based on the volume and the current pipeline that we're seeing today. So because of the beAT in the second quarter, it doesn't necessarily mean that we're going to see a slowdown in the new center adds in Q3 and Q4.

艾倫，這是賈里德。我可以接受那個。謝謝你的提問。因此，我們在過去幾個季度中看到了活躍植入中心新增數量的強勁增長。早在 2022 年，我們就討論過這個問題，當時醫院人員激增的情況已經得到解決，新冠疫情已經被擱置。我們開始看到醫院越來越有興趣啟動這些項目。這使我們能夠激活這些中心。我們提醒大家，簽約過程確實需要時間。因此，我們確實對通過價值評估和確定的冠軍簽訂合同的新中心的管道有了一些了解。然後，被確定為活躍植入中心的下一步是對第一位患者進行治療。這就是未來可能會出現一些醫院人員短缺問題的地方。但我認為，當我們展望第三季度和第四季度以及 2024 年時，僅根據我們今天看到的數量和當前管道，我們仍然預計每個季度會看到約 12 至 13 個新的主動植入中心。因此，由於第二季度的節拍，這並不一定意味著我們會看到第三季度和第四季度新中心的增長放緩。

Got it. That's good to hear. And then when I look at the guidance for $9.5 million to $10.2 million kind of an implied $10.0 million to $10.8 million in the fourth quarter, it seems like a pretty measured improvement given the increases we've seen so far this year. So why is that the appropriate level of increase we should forecast going forward? I think the general sense is that staffing, those kinds of dynamics have gotten better so far this year. So why shouldn't we see room for more upside in the back half?

知道了。聽起來還不錯。然後，當我查看第四季度 950 萬美元至 1020 萬美元的指導（即隱含的 1000 萬美元至 1080 萬美元）時，考慮到今年迄今為止我們所看到的增長，這似乎是一個相當有針對性的改進。那麼，為什麼我們應該預測未來的適當增長水平呢？我認為總體感覺是，今年到目前為止，人員配置、此類動態已經有所改善。那麼，為什麼我們不應該看到後半區有更多上升空間呢？

Yes, I'm happy to take that one again, Allen. Yes, I mean, we're really happy with the results that we've seen to date. I think as we look to provide guidance for Q3, we take into consideration what the current funnel is looking like, what the new active implanting center implant rates are starting to look like, and then also what's on the horizon. And the other thing that we take into consideration is the results we've seen so far in the quarter and what we've seen in July. I think as we march ahead into Q3 historically coming out of COVID, we have seen slowdowns in the month of August, right, where people take long vacations. Now there's been no signals of that for us yet. And we did just see our biggest jump ever from one quarter to the next from Q1 to Q2 just in a pure dollar amount of revenue. And so we didn't want to get ahead of ourselves with increasing the guidance too much and feel pretty comfortable with that range we gave of $9.5 million to $10.2 million.

是的，我很高興再次接受這個，艾倫。是的，我的意思是，我們對迄今為止所看到的結果感到非常滿意。我認為，當我們尋求為第三季度提供指導時，我們會考慮當前的漏斗情況、新的主動植入中心的植入率開始是什麼樣子，以及即將發生的情況。我們考慮的另一件事是本季度迄今為止以及 7 月份所看到的結果。我認為，當我們進入歷史上擺脫新冠疫情的第三季度時，我們已經看到了八月份的經濟放緩，人們在這個月份休假很長。現在我們還沒有收到任何信號。從第一季度到第二季度，我們確實看到了從一個季度到下一個季度的最大增幅，僅以純美元收入計算。因此，我們不想過度增加指導，並且對我們給出的 950 萬美元到 1020 萬美元的範圍感到非常滿意。

Our next question comes from Matthew O'Brien with Piper Sandler.

我們的下一個問題來自馬修·奧布萊恩和派珀·桑德勒。

So Nadim, this one is for you. You've got a lot of experience on the reimbursement side of things. And just help us get a sense for your -- the potential for you to get this APC code here in the final rule? Because if you don't, the 26,000 ASP is the first time I've heard that number specifically. Maybe I missed it, but based on what you're going to do this year from an ASP perspective, that's a pretty meaningful like 15% headwind just on the pricing side as we go into next year. So that's -- obviously, you're still going to be able to grow nicely with -- on the unit side, but you're going to have to deal with that headwind potentially on the ASP side of things. So just help us think about that dynamic on impact on the business, both on the top line and even gross profit line because gross profits are great, but ASPs are down 15%, that's going to be impactful to gross margin. So just help us think about the potential to get that extra code or get the [culture] you're looking for and then the impact of the business if that doesn't happen.

所以納迪姆，這個是給你的。您在報銷方面擁有豐富的經驗。請幫助我們了解您是否有可能在最終規則中獲得此 APC 代碼？因為如果你不這樣做的話，26,000 ASP 是我第一次聽說這個數字。也許我錯過了，但從 ASP 的角度來看，今年你要做的事情是非常有意義的，就像我們進入明年時在定價方面的 15% 逆風一樣。因此，很明顯，在單位方面，您仍然能夠很好地成長，但您將不得不應對 ASP 方面潛在的逆風。因此，請幫助我們考慮一下這種動態對業務的影響，包括營收甚至毛利潤，因為毛利潤很高，但平均售價下降了 15%，這將對毛利率產生影響。因此，請幫助我們考慮獲得額外代碼或獲得您正在尋找的[文化]的可能性，以及如果沒有發生的話對業務的影響。

Sure, Mark -- Matt, thanks for the question. I would ask Jared to answer the second half of the question. Let me answer the first one about the CMS and how to think about the process. We don't have much experience in this, but we looked at what happened exactly last year with a similar process followed by another small company that's now part of Zoll. I'm mentioning (inaudible) they follow the same process. The application was not mentioned in the summer's proposed ops, then they went in front of a panel made the case for it. We supported them as well as other constituencies and they got it at the end of the year. What does it tell us? Well, not much, because every case is different, no matter how much we can find similarities and try to find solace in here that it's worked for them, why wouldn't it work for us? That's not how CMS necessarily, we'll be looking at things, and we don't understand how -- what are the parameters that they will utilize in here to define whether they take the request like ours into account or not. That's why we have been modeling internally that the ASP will be lower in the future. And actually, let me turn here to Jared to walk you through a little bit about how we're thinking about it from a gross margin and ASP.

當然，馬克——馬特，謝謝你的提問。我會請賈里德回答問題的後半部分。讓我回答第一個關於 CMS 以及如何思考該流程的問題。我們在這方面沒有太多經驗，但我們研究了去年發生的情況，另一家現在屬於 Zoll 的小公司也採用了類似的流程。我提到（聽不清）他們遵循相同的流程。該應用程序在夏季提議的操作中並未提及，然後他們在一個小組面前提出了理由。我們支持他們以及其他選區，他們在年底得到了支持。它告訴我們什麼？好吧，沒什麼，因為每個案例都是不同的，無論我們能找到多少相似之處並試圖在這裡找到安慰，因為它對他們有用，為什麼對我們不起作用呢？這不一定是 CMS 的方式，我們將關注事物，但我們不明白他們將在此處使用哪些參數來定義他們是否考慮像我們這樣的請求。這就是為什麼我們一直在內部建模，認為未來的平均售價將會更低。實際上，讓我請賈里德向您介紹一下我們如何從毛利率和平均售價方面考慮這一問題。

Yes, Matt, I mean, this has been on the horizon for several years now, right? We knew the expiration of this add-on payment was going to be December 31, 2023. So we tend to take the conservative route when building these longer-term models. And so we wanted to take that into consideration to what our average selling price would be in '24 and beyond. And -- so as we look out to '24 with our base case, assuming we are in the same APC that we are today. That average selling price would be between 25,000 and 26,000. Now it doesn't drop off a cliff overnight, that number probably comes down over time. But I think the nice thing that we've shown here in 2023 with volume, we can see that cost per unit drop pretty dramatically. That's allowed us to achieve gross margins of 84% in the current quarter. And even with a decrease in the revenue or in the average selling price in 2024, we still believe gross margins of 80% in the short term would be attainable just based on volume in that cost per unit drop.

是的，馬特，我的意思是，這件事已經出現好幾年了，對吧？我們知道這筆附加付款將於 2023 年 12 月 31 日到期。因此，我們在構建這些長期模型時傾向於採取保守路線。因此，我們希望在考慮 24 年及以後的平均售價時考慮到這一點。而且，當我們展望 24 年的基本情況時，假設我們處於與今天相同的 APC 中。平均售價將在 25,000 至 26,000 之間。現在它不會在一夜之間跌落懸崖，這個數字可能會隨著時間的推移而下降。但我認為我們在 2023 年展示的銷量是件好事，我們可以看到單位成本大幅下降。這使得我們本季度的毛利率達到 84%。即使 2024 年收入或平均售價下降，我們仍然相信，僅根據單位成本下降量，短期內毛利率就能達到 80%。

Got it. Okay. Appreciate that. And then BeAT-HF came out recently. I'm just curious did you see any pause from some of your centers as they were digesting that information. Anybody that said, I don't like that or whereas potentially negatively impactful to the business? I know you still did well in Q2, but did you see any of that? And then just help us think about if you're able to get this indication for the treatment of HF, what -- I know it helps validate the technology some more, but what does that do from a selling perspective? Is it going to make it easier for new centers or just to go deeper in existing centers?

知道了。好的。感謝。最近 BeAT-HF 也問世了。我只是好奇你是否看到你們的一些中心在消化這些信息時有任何停頓。有人說，我不喜歡這樣，或者可能會對業務產生負面影響？我知道你在第二季度仍然表現出色，但是你看到了嗎？然後幫助我們思考一下，如果您能夠獲得治療心力衰竭的適應症，我知道這有助於進一步驗證該技術，但從銷售角度來看，這有什麼作用？它會讓新中心變得更容易還是只是讓現有中心更深入？

Excellent question. So let's start first with one reminder to everybody. Where we are right now, where the manuscript is not yet published and FDA has not given us the authorization to make any claims based on the data. We, as a company, are not allowed to proactively share with healthcare providers or patients the results of BeAT-HF. We can only answer questions when these questions are asked. So whatever impact we have seen so far has been limited to the physicians or other health care providers who have seen the BeAT-HF data presented at a scientific meeting by another healthcare provider. Period. How -- what's the percent of sites that have seen the data and comment on it. I don't have that split exactly. Nevertheless, we have not. I can repeat this over and over. We have not seen any slowdown even at the height of the uncertainty between February 21 and March 21, when we went out publicly and we mentioned that we did not meet the primary endpoint of the trial without sharing the data until a month later when the data was presented at the late-breaker at THD, during that month of uncertainty, even then we had not seen or observed any slowdown of activities in the site. That also kind of moved us into providing some level of directionality of revenue on a monthly basis in Q2, to alleviate any of this concern and give confidence in here that we are still on the right track.

很好的問題。首先，讓我們先提醒大家一下。我們現在所處的位置，手稿尚未發表，FDA 尚未授權我們根據數據提出任何主張。作為一家公司，我們不得主動與醫療保健提供者或患者分享 BeAT-HF 的結果。只有當這些問題被問到時我們才能回答。因此，到目前為止，無論我們看到什麼影響，都僅限於看過另一家醫療保健提供者在科學會議上提出的 BeAT-HF 數據的醫生或其他醫療保健提供者。時期。如何——查看過這些數據並對其發表評論的網站所佔的百分比是多少。我沒有準確的劃分。然而，我們沒有。我可以一遍又一遍地重複這句話。即使在 2 月 21 日至 3 月 21 日之間的不確定性最嚴重的時候，我們也沒有看到任何放緩，當時我們公開表示，我們沒有達到試驗的主要終點而沒有共享數據，直到一個月後數據公佈時在 THD 的晚間發布會上，在那個充滿不確定性的月份裡，我們沒有看到或觀察到該網站的活動有任何放緩。這也促使我們在第二季度每月提供一定程度的收入方向性，以減輕這種擔憂，並讓人們相信我們仍然走在正確的軌道上。

Now can I say for sure that those that have seen the results are implanting more patients, treating more patients or not. That's hard to quantify and hard to link our current growth with the results per se of BeAT-HF. To your second part of the question, what we expect if we get the labeling. Well, the total addressable market should increase a little bit based on the expansion of labeling. If you recall, when we did this and it's disclosed actually in full details in our S1 and subsequent filing when you go through the funnel, at the last step in the funnel, we eliminated from the total addressable market, many patients who have other co-morbid diseases assuming that when a therapy is assumed to be only treating symptoms, it may not be prescribed to a patient who have other comorbidities. So we went a little bit conservative on our assessment of the total addressable market. Now if we get the treatment labeling from FDA, we believe that some of this market will be addressable. Therefore, the total addressable market will increase. We're not at the point yet to disclose what the new number will be of new patients -- sorry, new patients eligible for therapy on a yearly basis yet, but at the right time, once we have clarity from FDA, what is the label that they're allowing us then we will do this exercise and we'll come back to everybody with it. So will we see an increase? Will we see an impact Possibly, but that will be next year. Will it be sufficient to alleviate your previous concern about the drop in ASP? I believe so, but we're not there yet. We're not yet at the point where we're giving guidance for 2024.

現在我可以肯定地說，那些看到結果的人是否正在植入更多患者、治療更多患者。這很難量化，也很難將我們當前的增長與 BeAT-HF 的結果本身聯繫起來。對於問題的第二部分，如果我們得到標籤，我們期望什麼。嗯，根據標籤的擴展，潛在市場總量應該會有所增加。如果您還記得，當我們這樣做時，它實際上在我們的 S1 和隨後的歸檔中進行了詳細披露，當您通過漏斗時，在漏斗的最後一步，我們從整個潛在市場中消除了許多患有其他疾病的患者-病態疾病假設當一種療法被認為僅治療症狀時，可能不會向患有其他合併症的患者開出該療法。因此，我們對整個潛在市場的評估有點保守。現在，如果我們獲得 FDA 的治療標籤，我們相信這個市場的一些部分將是可以解決的。因此，潛在市場總量將會增加。我們還沒有透露新患者的新數量——抱歉，每年都有資格接受治療的新患者，但在適當的時候，一旦我們從 FDA 得到明確的信息，標記他們允許我們，然後我們將進行此練習，然後我們會將其返回給每個人。那麼我們會看到增長嗎？我們可能會看到影響，但那是明年的事了。這足以緩解您之前對平均售價下降的擔憂嗎？我相信是這樣，但我們還沒有到那一步。我們還沒有到給出 2024 年指導的階段。

Our next question comes from Margaret Kaczor with William Blair.

我們的下一個問題來自瑪格麗特·卡佐爾和威廉·布萊爾。

I wanted to see if you guys would provide any additional details in terms of cadence of cases throughout the summer months and maybe into July and how that might compare to traditional summer seasonality.

我想看看你們是否能提供有關整個夏季甚至七月病例發生頻率的任何其他詳細信息，以及與傳統夏季季節性相比如何。

Margaret, this is Jared. So I know we've discussed month-to-month results here over the last few months after we came out with the Q1 results, we talked about how momentum was continuing into April. We also gave the update, I know at your conference about how May was continuing to be pretty strong just from a procedural perspective. But now that we've gotten through this process of disclosing the clinical data around BeAT-HF where there was maybe some uncertainty from investors out there about what was going to happen with the business. We're trying to get back into the traditional approach of sharing results on a quarterly basis and then giving that guidance for one quarter forward. So this is not in any way to indicate that we have concerns about what we're seeing in July, right? This is just us getting back to the normal cadence of deliver a quarter, give the guidance and move forward there. So I think we're going to pass on the question today to give any updates on July.

瑪格麗特，這是賈里德。所以我知道，在我們公佈第一季度業績後的過去幾個月裡，我們已經在這裡討論了逐月業績，我們討論了勢頭如何持續到四月份。我們還提供了最新情況，我在你們的會議上知道，從程序的角度來看，梅是如何繼續保持強勢的。但現在我們已經完成了披露 BeAT-HF 臨床數據的過程，投資者對於該業務的發展可能存在一些不確定性。我們正在嘗試回到按季度分享結果的傳統方法，然後給出未來一個季度的指導。所以這並不表明我們對 7 月份所看到的情況感到擔憂，對吧？這只是我們回到交付季度的正常節奏，提供指導並繼續前進。所以我想我們今天會轉達這個問題，以便在 7 月份提供任何更新。

No, understood. So I'll take a second crack at a slightly different question. But I'm just curious, as you look at the utilization growth that we've seen, you've now got some more tenured accounts. You've got some newer accounts online. Any surprises there? Or can you talk about the profile of account that's growing faster or slower, things are kind of on track, I guess, with your expectations?

不，明白了。所以我將再次嘗試一個稍微不同的問題。但我只是好奇，當您查看我們所看到的利用率增長時，您現在擁有了更多的終身帳戶。您有一些新的在線帳戶。有什麼驚喜嗎？或者您能談談增長更快或更慢的帳戶概況嗎？我想，事情已經步入正軌，符合您的期望？

Yes, excellent question, Margaret. This is Nadim by the way. Listen, two things. Number one, we've said previously that accounts that have been treating patients with Barostim for more than 2 years, are doing more patients in average per quarter, then those have been treating patients from 12 to 24 months ago. And these are also doing more patients per quarter than their most recent accounts that started treating patients with Barostim in the last 12 months. So that led us at the time, and we still stand behind the statement to conclude that the longer a site is treating patients with Barostim, the more they see the positive impact on their patients, the more they can spread the word around the institution to build more referral networks, to strengthen the deferral network around them, the more they end up treating patients with Barostim per quarter. So that stands. The second dynamic that is interesting just like in politics, right, everything displayed at the local level. So it's -- it depends a lot on the local competition between hospitals at a specific geography. And the more you have accounts in the geography, the more the competition start ramping up in hospitals trying to market the new therapies that they are offering their patients to the community, to the general cardiologists around them. The more we see the buzz augmenting in that geography and the more we see more sites wanting to come in for the fear of missing out on something big. So that bandwagon effect is real, and it happens at the local level, not at the national level. And that is very exciting for us to see.

是的，很好的問題，瑪格麗特。順便說一句，這是納迪姆。聽著，有兩件事。第一，我們之前說過，使用 Barostim 治療患者超過 2 年的賬戶平均每季度治療的患者數量比 12 至 24 個月前治療患者的賬戶要多。而且，與過去 12 個月內開始使用 Barostim 治療患者的最新賬戶相比，這些機構每季度治療的患者數量也更多。因此，這導致我們當時並且仍然支持該聲明，得出的結論是，一個機構治療 Barostim 患者的時間越長，他們就越能看到 Barostim 對患者的積極影響，他們就越能在機構內傳播信息建立更多的轉診網絡，以加強他們周圍的延期網絡，他們最終每季度使用 Barostim 治療的患者就越多。事實如此。第二個有趣的動態就像在政治中一樣，對吧，一切都在地方層面上展示。所以這在很大程度上取決於特定地區醫院之間的本地競爭。在某個地區擁有的客戶越多，醫院試圖向社區和周圍的普通心髒病專家推銷他們為患者提供的新療法的競爭就越激烈。我們越是看到該地區的嗡嗡聲越來越大，我們就越看到更多的網站因為擔心錯過一些大事而想要進入。因此，跟風效應是真實存在的，而且發生在地方層面，而不是國家層面。這對我們來說非常令人興奮。

Yes. Okay. That's very helpful. And then I'll sneak one more in since the first one was a little bit of a bust. But any kind of back-and-forth discussions you're having with the FDA on label expansion recently? Any kind of color maybe on concerns requests and whether you're confident, I guess, that they won't convene a panel.

是的。好的。這非常有幫助。然後我會再偷偷地放進去，因為第一個有點半身像。但是您最近與 FDA 就標籤擴展進行過任何形式的反复討論嗎？任何一種顏色都可能取決於您的要求以及您是否有信心他們不會召開小組會議。

You're always able to get from me some new things. So here is this one. Yes, we did have discussions with FDA prior to the submission. And if you recall at your conference, I mentioned publicly that we submitted the PMA supplement to FDA after having a few discussions for interaction with FDA prior to that, we became comfortable with where we stood with them. We prepared the dosage with all of the evidence, the totality of evidence that we submitted. Now the process is for FDA to take 100 days and then come back with questions. And we're in this period right now where we're waiting for them to do all of the analysis they need and come back to us with questions. That does not mean that we are not having other conversations with FDA in Paralel but not specific on the labeling of the PMA supplement.

你總能從我這裡得到一些新東西。這是這個。是的，我們在提交之前確實與 FDA 進行了討論。如果你還記得在你的會議上，我公開提到，我們在與 FDA 進行了一些互動討論之後，向 FDA 提交了 PMA 補充，我們對與他們的立場感到滿意。我們根據我們提交的所有證據準備了劑量。現在 FDA 的流程是 100 天，然後帶著問題回來。我們現在正處於這個時期，我們正在等待他們完成所需的所有分析並帶著問題回來給我們。這並不意味著我們沒有與 FDA 進行其他平行對話，但沒有具體討論 PMA 補充劑的標籤。

Question comes from Bill Plovanic with Canaccord Genuity.

問題來自 Canaccord Genuity 的 Bill Plovanic。

Great. Thanks. A couple of questions for -- just I want to understand the reimbursement. When we read through the ops, I guess we saw a T-Code-0266T that was reimbursing 30,400 and you're referencing 26,000, I think, on reimbursement. What code are you referencing on that in the ops. Just trying to figure that one out what we missed.

偉大的。謝謝。有幾個問題——我想了解報銷情況。當我們通讀操作時，我想我們看到了 T-Code-0266T，它報銷 30,400，我認為您引用的是 26,000 報銷。您在操作中引用了什麼代碼。只是想弄清楚我們錯過了什麼。

Yes, Bill, this is Nadim, by the way. I don't think I pronounced your name correctly, Plovanic. Listen, great question. So yes, it is the 0266T. That is the reimbursement for the device and the procedure. And what Jared is mentioning is the ASP of the device net of the procedure. Now when you say a 30,400 that's a national average. So sites at major cities are more expensive and reimbursement could go up all the way to $40,000 and smaller hospitals in rural areas in United States where the cost of living is lower, might go lower than $30,000. So that drives companies to be let's say, strategic in the account targeting in here. And that's why you see often novel therapies are targeting the big major metropolitan areas because the reimbursement is higher there. So when we're quoting $30,000, when you look at the average in the sites where Barostim is currently utilized, it's probably higher than 30,400. I'm sorry, will be the year talking about 2024. Jared, do you want to add something?

是的，比爾，順便說一句，這是納迪姆。我想我沒有正確發音你的名字，Plovanic。聽著，好問題。是的，它就是0266T。這是設備和程序的報銷。而Jared提到的是程序設備網的ASP。現在，當你說 30,400 時，這是全國平均水平。因此，大城市的醫院費用更高，報銷金額可能會一路上漲至 40,000 美元，而生活成本較低的美國農村地區的小型醫院的報銷金額可能會低於 30,000 美元。因此，這促使公司在客戶定位方面具有戰略性。這就是為什麼你經常看到新療法瞄準大城市地區，因為那裡的報銷更高。因此，當我們引用 30,000 美元時，如果您查看當前使用 Barostim 的網站的平均值，您會發現它可能高於 30,400。抱歉，我們談論的是 2024 年。Jared，您想補充一些內容嗎？

And remind us what's the reimbursement today?

並提醒我們今天的報銷是多少？

Yes, today, it's slightly below 30,000, but we have on top of it the transitional pass-through payment that adds another $10,000, $15,000 on top of it. And this is the TPT, the transition pass-through that expires by the end of this year. We've been granted this for 3 years, and that helps novel therapies to be adopted, and that's the process in the United States. Now if I compare and contrast with another product similar to ours, let me take the example of Inspire Medical, right? They did not have a transitional pass-through when they started their product. And they learn to live within that $30,000 envelope that we're talking about today. In our case, we got lucky. We received that transitional pass-through payment, but it's only for 3 years. And now it's arriving towards the end of it by the end of this year.

是的，今天，它略低於 30,000，但我們在此之上還有過渡性轉手付款，另外還增加了 10,000 美元，即 15,000 美元。這就是 TPT，過渡傳遞，將於今年年底到期。我們已經獲得此許可三年了，這有助於採用新療法，這就是美國的流程。現在如果我和另一個與我們類似的產品進行比較和對比，讓我以 Inspire Medical 為例，對嗎？當他們開始開發產品時，他們沒有過渡傳遞。他們學會瞭如何在我們今天討論的 30,000 美元的信封內生活。就我們而言，我們很幸運。我們收到了過渡性轉手付款，但期限只有 3 年。現在，到今年年底，它即將結束。

And then I was wondering if you could talk about the back wire. Now that you've had the submission and you're in the 100 days, your regulatory team, I would assume had a whole weekend off. And then are you kind of reenergized the BATwire or how should we think about that program?

然後我想知道你是否可以談談背面的電線。現在您已經提交了申請，並且還有 100 天的時間，我想您的監管團隊已經休息了整個週末。然後你是否讓 BATwire 重新煥發活力，或者我們應該如何考慮該計劃？

As a company, yes, we're super energized, but the reality on the ground is more nuanced and more difficult than this. The enrollment rate for BATwire has been more challenging than we have anticipated. I think post COVID, patients are a little bit wary regarding experimental approaches. And when they have a choice for a given indication between an FDA-approved product like Barostim, that is already minimally evasive and enrolling in a clinical trial with an uncertain outcome because not FDA approved for BATwire, it seems that the majority of the patients right now are preferring to go the safer route and selecting Barostim. We've seen this in the numbers. We've seen this in our growth in Barostim, but the price we're paying right now is a slower enrollment in BATwire. That said, while we remain blinded to the efficacy of BATwire, we see the safety on a daily basis, and we report on the safety of patients every 5 or 10 patients to FDA. And so far, we're super, super happy with how safe that approaches for patients. But again, let me remind everybody, we're still blinded to the efficacy of this. And as we proceed forward with the trial, we'll provide more updates when we have something more to say till about this.

作為一家公司，是的，我們充滿活力，但實際情況比這更加微妙和困難。 BATwire 的入學率比我們預期的更具挑戰性。我認為在新冠疫情之後，患者對實驗方法有點謹慎。當他們針對特定適應症在 Barostim 等 FDA 批准的產品之間進行選擇時，這已經是最低限度的迴避，並且由於 BATwire 未獲得 FDA 批准而參加了結果不確定的臨床試驗，似乎大多數患者都是正確的現在更願意走更安全的路線並選擇 Barostim。我們已經在數字中看到了這一點。我們在 Barostim 的增長中看到了這一點，但我們現在付出的代價是 BATwire 的註冊速度較慢。也就是說，雖然我們對 BATwire 的功效仍然視而不見，但我們每天都會看到其安全性，並且每 5 或 10 名患者向 FDA 報告一次患者的安全性。到目前為止，我們對這種方法對患者的安全性感到非常非常滿意。但我再次提醒大家，我們仍然對其功效視而不見。隨著試驗的進展，當我們對此有更多要說的時候，我們將提供更多更新。

Yes. On that topic, do you have any kind of updated thoughts on when you might complete enrollment or how far through enrollment you are, just to give us an idea?

是的。關於這個話題，您對何時完成註冊或註冊進行到什麼程度有什麼最新的想法，只是為了給我們一個想法？

Yes. No, let me pond on this. We will provide a longer update, I believe, probably next quarter when we'll learn a little bit more about the trend in the study in terms of enrollment. But what you hear from me here is the concern about the fact that the enrollment has been more challenging than we anticipated, and it's going slower.

是的。不，讓我思考一下。我相信，我們可能會在下個季度提供更長的更新，屆時我們將更多地了解該研究在入學方面的趨勢。但你從我這裡聽到的是對這樣一個事實的擔憂：招生比我們預期的更具挑戰性，而且進展速度更慢。

Our next question comes from Alex Nowak with Craig Hallum.

我們的下一個問題來自亞歷克斯·諾瓦克和克雷格·哈勒姆。

I want to follow up to a couple of questions on the proposed OPPS that was out there. We talked a bit on pricing, but I actually want to pivot just a little bit. Just trying to understand, how is Medicare thinking about Barostim? Were you just surprised that there was no play no mention of Barostim anywhere within the documents. I'm trying to understand, is that an outright the dial of getting Barostim a new APC code? Or is that simply that's the proposal for the new APC code just didn't make it into the proposed documents yet?

我想跟進有關擬議 OPPS 的幾個問題。我們就定價問題進行了一些討論，但實際上我想稍微調整一下。只是想了解 Medicare 如何看待 Barostim？您是否只是驚訝於文檔中沒有任何地方提到 Barostim ？我想了解一下，這是否就是讓 Barostim 獲得新 APC 代碼的直接方法？或者這只是新 APC 代碼的提案尚未納入提案文件？

Alex, it's a great question, by the way. I wish I know the answer. Would I prefer to have a negative comment explicit, which often what they do is they will say, yes, we received this request and nope, we will not give it to you or have them stay silent I don't know which one is better seriously. I think silent is better. It leaves the door open to have the dialogue with the panel in August. But it's hard to know. It is really hard to know, Alex.

亞歷克斯，順便說一句，這是一個很好的問題。我希望我知道答案。我是否希望有明確的負面評論，他們通常會說，是的，我們收到了這個請求，不，我們不會給你或讓他們保持沉默我不知道哪個更好嚴重地。我覺得沉默比較好這為八月份與專家組的對話敞開了大門。但這很難知道。這真的很難知道，亞歷克斯。

Well, getting a new indication or an upgraded label expansion at FDA, will that have any influence at all on the APC code that Medicare will ultimately choose in the final documents?

那麼，在 FDA 獲得新的適應症或升級的標籤擴展，這會對 Medicare 最終在最終文件中選擇的 APC 代碼產生任何影響嗎？

The way Medicare is structured, they have -- think about it as three different pillars that are independent. You have the coding, the payments and the coverage. The labeling expansion will impact coverage discussions, it would not impact payment, and it do not impact coding. Payment under the CMS regulations is driven almost entirely by the cost of charges that hospitals report back to CMS that CMS analyzes. So CMS tries to put therapies into buckets so that they don't have to price each one, each device or each flavor of a device different, they put them in bands or in buckets, and they try to price these buckets based on the (inaudible) average of the claim data that they receive from hospitals. And it's not linked to an efficacy data or label -- or labeling or anything like that, unfortunately.

他們將醫療保險的結構方式視為三個獨立的不同支柱。您擁有編碼、付款和承保範圍。標籤擴展將影響覆蓋範圍討論，不會影響付款，也不會影響編碼。 CMS 規定下的付款幾乎完全由醫院向 CMS 報告並由 CMS 分析的費用決定。因此，CMS 嘗試將療法放入桶中，這樣他們就不必對每種療法、每種設備或設備的每種風格進行不同的定價，他們將它們放入帶狀或桶中，並嘗試根據（聽不清）他們從醫院收到的索賠數據的平均值。不幸的是，它與功效數據或標籤或標籤或類似的東西沒有聯繫。

Okay. That makes sense. And then obviously, we've seen some really strong sales results this year, last year as well. You've been adding sales territories three on average per quarter. What is the right number? What is the sales leadership team asking for? And then this might be a little bit a follow-up question for cash flow breakeven just provide some more insights on how we get there with the capital and the resources on hand. When do we start to see the OpEx growth start to slow. I think it sounds like 2024, but just current thoughts there.

好的。這就說得通了。顯然，我們今年和去年都看到了一些非常強勁的銷售業績。您平均每季度增加三個銷售區域。正確的數字是多少？銷售領導團隊的要求是什麼？這可能是現金流盈虧平衡的一個後續問題，只是提供了一些關於我們如何利用現有資本和資源實現這一目標的更多見解。我們什麼時候開始看到運營支出增長開始放緩。我認為這聽起來像是 2024 年，但只是目前的想法。

Excellent two questions, Alex. Let me take the easy one, and I'll leave the difficult one to Jared. So yes, we believe the right number is three per quarter. As we looked into our path to getting to cash flow breakeven without needing to raise dilutive capital. It's a cone of possibilities. But if we go too slow in the growth rate, we will never get there. And if we go too fast, we'll burn the cash way too soon before getting there. Why is that? It's because when you hire a rep, it takes 6, 9, 12 months for the rep to be trained, to start creating the relationships in the field and to take the accounts through the contracting process that we know take many months until they can treat their first patients. So during that period, you're carrying the cost of the rep, the territory manager without getting real benefit from additional sales in that first year. So if you load it up too much upfront, you burn through the cash sooner without being able to get to the cash flow breakeven. If we were having your eye this conversation 5 years ago, where the market was rewarding growth irrespective of the need to raising capital. Maybe that would have been our strategy. But today, in this current environment where investors are focusing on the ability of companies to generate cash flow. It did not -- this did not appear to be the right strategy for us to grow faster than this. But let me turn to Jared to walk you through the thinking process.

很好的兩個問題，亞歷克斯。讓我先講容易的，然後把困難的留給賈里德。所以是的，我們認為正確的數字是每季度三個。當我們研究如何在不需要籌集稀釋資本的情況下實現現金流收支平衡時。這是一個充滿可能性的錐體。但如果我們的增長速度太慢，我們將永遠無法實現這一目標。如果我們走得太快，我們就會在到達目的地之前就燒掉現金。這是為什麼？這是因為，當您僱用銷售代表時，銷售代表需要接受 6、9、12 個月的培訓，才能開始在現場建立關係，並通過合同流程處理賬戶，而我們知道，這需要幾個月的時間才能處理。他們的第一批病人。因此，在此期間，您需要承擔代表、區域經理的成本，而無法從第一年的額外銷售中獲得真正的收益。因此，如果你預先加載太多，你就會更快地耗盡現金，而無法達到現金流收支平衡。如果您留意 5 年前的這段對話，當時的市場正在獎勵增長，而不管是否需要籌集資金。也許這就是我們的策略。但如今，在當前的環境下，投資者關注的是公司產生現金流的能力。但事實並非如此——這似乎不是我們增長速度更快的正確策略。但讓我請賈里德來引導您完成思考過程。

Yes, Alex, it's something we've been talking about for a while was 2023 was the flat lining year from a cash burn perspective. So the number that we burned in '22, the expectation was that we would be burning a number that was very similar to that in 2023 based on the guidance that we had put out at the beginning of the year. As we march into 2024 and beyond, that's where we see that cash burn number coming down and seeing the leverage in the model start to play out, where the growth in OpEx is a smaller dollar amount than the growth in revenue. And that's how we get to that cash flow breakeven number.

是的，Alex，我們已經討論了一段時間了，從現金消耗的角度來看，2023 年是平淡的一年。因此，我們在 22 年燃燒的數字，預計根據我們年初發布的指導，我們將燃燒一個與 2023 年非常相似的數字。當我們進入 2024 年及以後時，我們會看到現金消耗數量下降，並且模型中的槓桿作用開始發揮作用，其中運營支出的增長量小於收入的增長量。這就是我們達到現金流盈虧平衡數字的方法。

Our next question comes from Frank Takkinen with Lake Street Capital Markets.

我們的下一個問題來自 Lake Street Capital Markets 的 Frank Takkinen。

I wanted to ask slightly differently related to BeAT-HF data? I know it came up that was there any negative impact from that data and fully understanding it's not on label right now, so it can't be marketed and it's off-label technically, but was there on the flip side, any positive impact that you potentially saw from active implanting centers that were familiar with the data? I know as a patient, if you can find your way to 34% reduction in LVAD transplant. That's probably something you ask your physician about despite or whether or not it is or is not on label. So maybe any tailwind as it relates to that, that you may have seen at some of your active implanting centers.

我想問與 BeAT-HF 數據略有不同？我知道這些數據是否有任何負面影響，並且充分理解它現在不在標籤上，因此無法上市，而且從技術上講它是標籤外的，但另一方面，是否有任何積極影響您可能從熟悉這些數據的主動植入中心看到過嗎？我知道作為一名患者，如果您能找到使 LVAD 移植減少 34% 的方法。不管它是否在標籤上，您都可能會詢問您的醫生。因此，也許與此相關的任何順風車，您可能已經在一些活躍的植入中心看到過。

Frank, excellent question. So when we unblinded the data, and the data was presented at the late breaker. It's a common practice to have the steering committee present the data as well to the investigators who participated in the trial as a courtesy. And many of those investigators are current customers. Current Barostim customers. And the feedback we got at that time was very positive, super encouraging. Yes, there were questions about, okay, what does it mean not to have met the primary endpoint, but the focus on the long-term safety, the durability of the symptomatic improvement. And when you look at the totality of evidence, particularly as compounded with the win ratio analysis that was positive, and the trend in the mortality data, people felt very good about the fact. And we spoke about it publicly back then. But I think probably it might have appeared to be a bit defensive when we were trying to convey a positive message and there was some negative sentiments around the messaging that we did. In any way that positive messaging, we believe, has helped carry the day for us and is the reason why we're seeing that trajectory change slightly this year versus last year in terms of growth.

弗蘭克，很好的問題。因此，當我們對數據進行揭盲時，數據是在後期斷路器中呈現的。通常的做法是讓指導委員會出於禮貌向參與試驗的研究人員提供數據。其中許多調查人員都是現有客戶。目前的 Barostim 客戶。當時我們得到的反饋非常積極，非常令人鼓舞。是的，有人問，好吧，沒有達到主要終點意味著什麼，但重點是長期安全性、症狀改善的持久性。當你查看全部證據時，特別是結合積極的勝率分析以及死亡率數據的趨勢，人們對這一事實感覺非常好。我們當時公開談論過這件事。但我認為，當我們試圖傳達積極的信息並且我們所做的信息周圍存在一些負面情緒時，它可能看起來有點防禦性。我們相信，無論如何，積極的信息都幫助我們取得了勝利，也是我們看到今年的增長軌跡與去年相比略有變化的原因。

So with this in mind, yes, we believe it had a positive impact on our growth. Now we're talking here about the same patient population. We're not talking outside of the current labeling. Listen, we estimated, even with our conservative method back when we did the IPO 2 years ago that there were 55,000 new patients every year that could be eligible for our therapy. Those are new patients every year. So if you don't read them this year, there will be another 55,000 the next year and so forth. And right now, what are we talking about? Less than 1,000 or 2,000 patients we're treating every year, that's still a single-digit percentage point of this population. So there's a key here -- is to give more ammunition to the sites who are treating patients with Barostim when they, in turn, preach to the referring physicians about the virtues of Barostim, that's the key element in here is how can a treating -- a Barostim treating center can start spreading reward to the referral network about the benefit of Barostim. And that's what the data allows for those who have been able to see it at scientific meetings. Did I answer your question, Frank?

因此，考慮到這一點，是的，我們相信這對我們的增長產生了積極影響。現在我們在這裡談論的是相同的患者群體。我們不是在當前標籤之外討論。聽著，我們估計，即使採用兩年前 IPO 時的保守方法，每年仍有 55,000 名新患者有資格接受我們的治療。這些都是每年的新病人。所以如果你今年不讀，明年還會有 55,000 篇，以此類推。現在，我們在談論什麼？我們每年治療的患者不到 1,000 或 2,000 名，但這仍然只佔該人群的個位數百分比。因此，這裡有一個關鍵 - 是為使用 Barostim 治療患者的網站提供更多彈藥，而他們反過來向轉診醫生宣傳 Barostim 的優點，這就是這裡的關鍵要素是如何治療 - - Barostim 治療中心可以開始向推薦網絡傳播有關 Barostim 益處的獎勵。對於那些能夠在科學會議上看到它的人來說，這就是數據所允許的。我回答你的問題了嗎，弗蘭克？

Yes. That's perfect. And then maybe just one other one on utilization. I was hoping you can maybe approximate what percentage of your 140 or so are running at 12 or more implants per year. Just trying to get a sense for how that average is computed and how many of your centers are really contributing to bringing that average up.

是的。那很完美。然後也許只是關於利用率的另一項。我希望您能大概知道您的 140 名左右的人中每年進行 12 次或更多種植體的比例是多少。只是想了解該平均值是如何計算的，以及有多少中心真正為提高該平均值做出了貢獻。

Yes. Frank, I'll take that one. So one thing I'd like to call out for everybody is. So we have 140 active implanting centers. Just based on the additions we've done over the last 4 quarters or so, half of them were added, right, in the last year. So that means only 70 of the centers have been with us more than 12 months as of the end of June this year. So we don't have a lot of centers that have reached that 2-plus year marker. But we are seeing really good signs for the centers that have been with us 2-plus years to see that average implanting ratio reach that long-term average of one per month or 12 per year that you're asking about. So we're not going to go into the details on the exact number, but we've talked about it in the past, it's more than a couple of handfuls of centers that have started reaching that average in the more recent quarters.

是的。弗蘭克，我要那個。所以我想向大家呼籲的一件事是。所以我們有 140 個活躍的植入中心。僅根據我們在過去四個季度左右所做的添加，其中一半是在去年添加的，對吧。因此，這意味著截至今年 6 月底，只有 70 個中心在我們的服務時間超過 12 個月。因此，我們沒有很多中心達到了兩年多的標準。但我們看到，那些已經與我們合作兩年多的中心出現了非常好的跡象，平均植入率達到了您所詢問的每月 1 例或每年 12 例的長期平均水平。因此，我們不會詳細說明確切的數字，但我們過去已經討論過，不僅僅是少數幾個中心在最近幾個季度開始達到這一平均水平。

There are no further questions at this time. I would like to turn the floor back over to Nadim for closing comments.

目前沒有其他問題。我想將發言權交還給納迪姆以徵求結束意見。

Yes. Thank you, operator, and thanks, everyone, for joining us for our second quarter earnings call. We appreciate your ongoing support, and we look forward to updating you on our progress on our next update.

是的。謝謝運營商，也謝謝大家參加我們的第二季度財報電話會議。感謝您一直以來的支持，我們期待向您通報我們下一次更新的最新進展。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。