Axonics Inc (AXNX) 2023 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Axonics Third Quarter 2023 Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

女士們先生們，謝謝你們的支持。歡迎參加 Axonics 2023 年第三季業績電話會議。 （操作員指示）請注意，今天的會議正在錄製中。

I would like now to turn the conference over to Neil Bhalodkar, Axonics Investor Relations. Please go ahead.

我現在想將會議交給 Axonics 投資者關係部的 Neil Bhalodkar。請繼續。

Thank you, Michelle. Good afternoon, and thank you for joining Axonics' Third Quarter 2023 Results Conference Call. Presenting on today's call are Raymond Cohen, Chief Executive Officer; and Kari Keese, Chief Financial Officer.

謝謝你，米歇爾。下午好，感謝您參加 Axonics 2023 年第三季業績電話會議。出席今天電話會議的有執行長雷蒙德‧科恩 (Raymond Cohen)；和財務長 Kari Keese。

Before we begin, I'd like to remind listeners that statements made on this conference call that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. While these forward-looking statements are based on management's current expectations and beliefs, these statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause results to differ materially from the expectations expressed on this conference call. These risks and uncertainties are disclosed in more detail in Axonics filings with the Securities and Exchange Commission, all of which are available at www.sec.gov. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date, October 30, 2023. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, circumstances or unanticipated events that may arise.

在我們開始之前，我想提醒聽眾，本次電話會議上發表的有關未來計劃、事件、前景或業績的聲明屬於 1995 年《私人證券訴訟改革法案》所定義的前瞻性聲明。前瞻性陳述基於管理層目前的預期和信念，這些陳述受到許多風險、不確定性、假設和其他因素的影響，這些因素可能導致結果與本次電話會議上表達的預期有重大差異。這些風險和不確定性在 Axonics 向美國證券交易委員會提交的文件中進行了更詳細的揭露，所有這些文件均可在 www.sec.gov 上取得。請聽眾不要過度依賴這些前瞻性陳述，這些陳述僅截至今天（2023 年 10 月 30 日）。除法律要求外，Axonics 不承擔更新或修改任何前瞻性陳述以反映新情況的義務。可能出現的信息、情況或意外事件。

With that, I'd now like to turn the call over to Ray.

有了這個，我現在想把電話轉給雷。

Thank you, Neil, and I would like to welcome everyone joining this afternoon's call.

謝謝尼爾，我歡迎大家參加今天下午的電話會議。

With respect to the third quarter, we had strong company-wide execution. We generated solid results in this quarter with revenue at $93.1 million, representing an overall increase of 32% compared to the prior year period.

就第三季而言，我們在全公司範圍內的執行力很強。本季我們取得了穩健的業績，營收達到 9,310 萬美元，與去年同期相比整體成長了 32%。

More specifically, sacral neuromodulation revenue was $73.9 million, an increase of 30% compared to the prior year period. This strong level of growth was achieved despite a 42% growth comparison in Q3 of last year, a period which benefited from the launch of our F15 recharge-free sacral neuromodulation system.

更具體地說，骶神經調節收入為 7,390 萬美元，較上年同期成長 30%。儘管去年第三季成長了 42%，但仍實現瞭如此強勁的成長水平，這段時期得益於我們推出的 F15 免充電骶神經調節系統。

Over the last 12 months, approximately half of our SNM revenue growth in the United States has been driven by higher utilization and share of wallet at existing accounts, with the other half of our growth coming from the addition of competitive accounts that are now doing business with Axonics.

在過去 12 個月中，我們在美國 SNM 收入成長的大約一半是由現有帳戶的利用率和錢包份額的提高所推動的，另一半的成長來自於正在進行業務的競爭性帳戶的增加與Axonics 合作。

Drilling down even further, over the last 12 months, our existing customers have grown their SNM procedural volumes in the high teens compared to the prior 12-month period. We believe this growth represents or reflects the significant unmet need of the people with moderate to severe incontinence, physicians' enthusiasm for partnering with Axonics on SNM and increasing public awareness of advanced therapies, thanks to our DTC campaign.

更進一步，在過去 12 個月中，與之前 12 個月期間相比，我們現有客戶的 SNM 程式量增加了十幾倍。我們相信，這種成長代表或反映了中度至重度失禁患者的顯著未滿足需求、醫生與 Axonics 合作開發 SNM 的熱情以及公眾對先進療法的認識不斷提高，這要歸功於我們的 DTC 活動。

Internationally, while our SNM revenue is modest, sales of SNM systems grew by nearly 40%, compared to last year as a result of measurable contribution from our recently deployed direct sales force in Australia. We are working with TGA, which is Australia's competent authority and BSI, our notified body in Europe, to gain approval for the F15 recharge-free SNM system and are optimistic that these approvals will have a positive impact on international SNM revenue in 2024. The exact timing of these approvals is difficult to predict given the recent changes in the regulatory review process.

在國際上，雖然我們的 SNM 收入不大，但由於我們最近在澳洲部署的直銷團隊做出了巨大貢獻，SNM 系統的銷售額與去年相比增長了近 40%。我們正在與澳洲主管機關 TGA 和我們在歐洲的公告機構 BSI 合作，以獲得 F15 免充值 SNM 系統的批准，並樂觀地認為這些批准將對 2024 年的國際 SNM 收入產生積極影響。鑑於監管審查流程最近發生的變化，很難預測這些批准的確切時間。

Moving on to Bulkamid, revenue was $19.2 million, an increase of 42% compared to the prior year period. Results were driven by increasing reorder rates from existing accounts, the onboarding of new accounts and the addition of additional sales personnel primarily focused on promoting Bulkamid. Our gross margin in the third quarter was 74.2%, which is up from 72.8% in Q3 of last year. We also generated $14 million of adjusted EBITDA and nearly $4 million of GAAP net income in the quarter as we continue to realize and benefit from the operating leverage of our business.

Bulkamid 的營收為 1,920 萬美元，比去年同期成長 42%。業績的推動因素包括現有客戶再訂購率的提高、新客戶的加入以及主要致力於推廣 Bulkamid 的額外銷售人員的增加。我們第三季的毛利率為 74.2%，高於去年第三季的 72.8%。隨著我們繼續實現業務的營運槓桿並從中受益，本季度我們還產生了 1400 萬美元的調整後 EBITDA 和近 400 萬美元的 GAAP 淨利潤。

Now Kari will discuss our financial performance in further detail in her prepared remarks. But before we go there, I'd like now to provide several other corporate updates.

現在，卡里將在她準備好的演講中進一步詳細討論我們的財務表現。但在我們討論之前，我現在想提供一些其他公司的最新情況。

We have approximately 415 commercial team members in the United States, of which 200 are directly involved in selling or sales management. The balance of the team are field clinical specialists, field marketing specialists and remote therapy support personnel. Internationally, we have approximately 25 field-based personnel located in Western Europe and Australia. We are well staffed at this time and expect only a modest increase in our commercial headcount heading into 2024.

我們在美國大約有 415 名商業團隊成員，其中 200 名直接參與銷售或銷售管理。團隊的其餘成員包括現場臨床專家、現場行銷專家和遠距治療支援人員。在國際上，我們在西歐和澳洲擁有大約 25 名現場人員。目前我們的人員配備充足，預計到 2024 年我們的商業員工人數只會小幅增加。

Turning to the Axonics' Find Real Relief direct-to-consumer advertising campaign. We continue to generate more than 10,000 qualified leads each month. Qualified leads are those individuals that complete a symptom questionnaire on our website telling us about their symptoms and providing contact information. In addition, many of our customers tell us that patients come into their practices asking about Axonics therapy after seeing our ads on television or on the Internet. The campaign continues to generate goodwill with our physician customers who are grateful that we are getting the message out to the public and that there are advanced therapies available to treat adults with these conditions.

轉向 Axonics 的 Find Real Relief 直接面向消費者的廣告活動。我們每個月都會繼續產生超過 10,000 個合格的銷售線索。合格的潛在客戶是指在我們網站上完成症狀問卷、告訴我們他們的症狀並提供聯絡資訊的個人。此外，我們的許多客戶告訴我們，患者在看到我們在電視或網路上的廣告後，開始諮詢 Axonics 治療。該活動繼續在我們的醫生客戶中產生善意，他們很感激我們向公眾傳達了這一信息，並且有先進的療法可以治療患有這些疾病的成年人。

Now we continue to see that over half of the individuals filling out these questionnaires are treatment naive, underscoring the notion that people don't know that it's not a normal part of aging to leak urine or suffer from bowel dysfunction. Our call center continues to work diligently to connect qualified leads with urology specialists in their local community. The DTC program is yielding measurable SNM and Bulkamid revenue with an encouraging return on investment.

現在我們繼續看到，超過一半填寫這些問卷的人都沒有接受過治療，這突顯了這樣一種觀念，即人們不知道漏尿或腸道功能障礙並不是衰老的正常現象。我們的呼叫中心繼續努力工作，將合格的潛在客戶與當地社區的泌尿科專家聯繫起來。 DTC 計劃正在產生可觀的 SNM 和 Bulkamid 收入以及令人鼓舞的投資回報。

Given the success of the DTC program, we recently launched new television commercials relating to the conditions of stress urinary incontinence and bowel dysfunction as well as refreshing our OAB commercials. Other marketing, educational and clinical initiatives include, but are not limited to, our attendance at national and regional medical conferences, monthly programs to educate APPs, those are APs, NPs and RNs, visits to our Irvine campus by physicians, master courses for physicians seeking to better their skills for SNM and/or Bulkamid, educational fellows and residency programs, webinars and helping -- and also helping to facilitate mailings from physicians to patients who may not be aware that there are new products that can address their incontinence symptoms.

鑑於 DTC 計劃的成功，我們最近推出了與壓力性尿失禁和腸道功能障礙相關的新電視廣告，並更新了我們的 OAB 廣告。其他行銷、教育和臨床舉措包括但不限於我們參加國家和地區醫學會議、每月教育 APP（即 AP、NP 和 RN）計劃、醫生參觀我們的爾灣校區、為醫生開設碩士課程尋求提高SN​​M 和/或Bulkamid 技能、教育研究員和住院醫師計劃、網路研討會和幫助，並幫助促進醫生向可能不知道有新產品可以解決失禁症狀的患者發送郵件。

Turning to product development initiatives. We continue to expect the foramen finder lead placement technology that we acquired earlier this year to be commercially available in mid-2024. We are also making good progress on our new external trial system that aims to enhance the external trial experience and make it more comfortable for patients and more convenient for physicians. We have additional initiatives underway that we will not be discussing publicly at this time due to competitive reasons.

轉向產品開發計劃。我們仍預期今年稍早獲得的椎間孔定位器引線置入技術將於 2024 年中期投入商業化。我們的新外部試驗系統也取得了良好進展，旨在增強外部試驗體驗，讓患者更舒適，讓醫生更方便。我們正在進行其他舉措，由於競爭原因，我們目前不會公開討論這些舉措。

So at this point, I'd like to turn the call over to Kari for her detailed review of financial results. Kari?

因此，此時此刻，我想將電話轉給卡里，讓她詳細審查財務表現。卡里？

Thanks, Ray.

謝謝，雷。

As Ray noted, Axonics generated net revenue of $93.1 million in the third quarter of 2023. This represented an increase of 32% compared to the prior year period. Sacral neuromodulation revenue was $73.9 million, of which 98% was generated in the U.S. Bulkamid revenue was $19.2 million, of which 81% was generated in the U.S.

正如 Ray 指出的那樣，Axonics 在 2023 年第三季的淨收入為 9,310 萬美元。這比去年同期成長了 32%。骶神經調節收入為 7,390 萬美元，其中 98% 來自美國。Bulkamid 收入為 1,920 萬美元，其中 81% 來自美國。

Gross profit in the third quarter of 2023 was $69.1 million representing a gross margin of 74.2% compared to 72.8% in the prior year period. Through the first 9 months of 2023, Axonics generated a gross margin of 74.7%.

2023 年第三季的毛利為 6,910 萬美元，毛利率為 74.2%，而去年同期為 72.8%。 2023 年前 9 個月，Axonics 的毛利率為 74.7%。

While we are pleased with these results, as you know, gross margin is sensitive to overhead absorption, manufacturing yields, and supply chain disruptions. Taking these factors into account and given that we are continuing to ramp up the manufacturing lines of the R20 and F15 sacral neuromodulation products, we expect gross margin in the fourth quarter of 2023 to range between 74% to 75%. Operating expenses were $69.8 million in the third quarter of 2023. Excluding acquisition-related expenses, this compares to $59.4 million in the prior year period.

雖然我們對這些結果感到滿意，但如您所知，毛利率對管理費用吸收、製造產量和供應鏈中斷很敏感。考慮到這些因素，並考慮到我們正在繼續擴大 R20 和 F15 骶神經調節產品的生產線，我們預計 2023 年第四季的毛利率將在 74% 至 75% 之間。 2023 年第三季的營運費用為 6,980 萬美元。不包括收購相關費用，而去年同期為 5,940 萬美元。

We expect operating expenses of approximately $79 million in the fourth quarter of 2023, which is consistent with the $280 million of adjusted operating expenses in 2023 that we have guided to previously. Net income in the third quarter of 2023 was $3.9 million, aided by interest income of just over $4 million. This result compares to a net loss in the prior year period of $16.3 million.

我們預計 2023 年第四季的營運費用約為 7,900 萬美元，這與我們先前指導的 2023 年調整後營運費用 2.8 億美元一致。 2023 年第三季的淨利為 390 萬美元，利息收入略高於 400 萬美元。相比之下，去年同期的淨虧損為 1,630 萬美元。

In the third quarter of 2023, Axonics generated $14 million of adjusted EBITDA, compared to $3.3 million in the prior year period. The attractive financial profile of the company and the inherent operating leverage of our business model continues to be evident in our financial results. Cash, cash equivalents and short-term investments were $344.7 million as of September 30, 2023, an increase of $13.2 million compared to June 30, 2023.

2023 年第三季度，Axonics 調整後 EBITDA 為 1,400 萬美元，去年同期為 330 萬美元。公司有吸引力的財務狀況和我們業務模式固有的營運槓桿在我們的財務表現中繼續顯而易見。截至2023年9月30日，現金、現金等價物及短期投資為3.447億美元，較2023年6月30日增加1,320萬美元。

Turning to fiscal year 2023 guidance. Our updated outlook is as follows: we are increasing total company's full year guidance to $362 million, up from $358 million previously. This represents growth of 32% compared to fiscal year 2022. We anticipate SNM revenue of $288.5 million, an increase of 30% compared to fiscal year 2022 and Bulkamid revenue of $73.5 million, an increase of 42% compared to fiscal year 2022.

轉向 2023 財年指導。我們更新後的展望如下：我們將公司全年指引總額從先前的 3.58 億美元提高到 3.62 億美元。與 2022 財年相比成長 32%。我們預期 SNM 營收為 2.885 億美元，比 2022 財年成長 30%，Bulkamid 營收為 7,350 萬美元，比 2022 財年成長 42%。

That concludes our prepared remarks. I will now turn the call back to Neil.

我們準備好的演講到此結束。我現在將把電話轉回給尼爾。

Great. Thanks, Kari.

偉大的。謝謝，卡里。

At this time, we are ready to begin the Q&A session. We would like each analyst to have an opportunity to ask a question. So we request that you please limit yourself to 1 question only. If you have an additional question, please reenter the queue and we will take your second question if time permits.

此時，我們準備開始問答環節。我們希望每位分析師都有機會提出問題。因此，我們要求您只回答 1 個問題。如果您還有其他問題，請重新進入隊列，如果時間允許，我們將回答您的第二個問題。

With that, Michelle, please begin the Q&A session.

那麼，米歇爾，請開始問答環節。

(Operator Instructions) The first question comes from Chris Pasquale with Nephron Research.

（操作員說明）第一個問題來自 Nephron Research 的 Chris Pasquale。

Congrats on a nice quarter, guys.

恭喜你們度過了一個美好的季度。

Ray, I wanted to ask about the stat you gave around your existing customers growing at a high teens rate. I think that's a really interesting data point above what we think the overall market is growing. I'm curious what do you think the biggest drivers of that have been? Are you able to really direct the DTC efforts to those accounts and so you're helping to funnel patients there? Or do you think that it's really a function of having the Axonics technology at those accounts and having a more appealing therapy to offer those patients.

雷，我想問您提供的現有客戶以青少年高成長率成長的統計數據。我認為這是一個非常有趣的數據點，高於我們認為的整體市場成長的數據點。我很好奇您認為最大的推動因素是什麼？您是否能夠真正將 DTC 的工作導向這些帳戶，從而幫助將患者轉移到那裡？或者您是否認為這實際上是在這些帳戶上使用 Axonics 技術並為這些患者提供更具吸引力的治療的功能。

Thanks, Chris. Appreciate the question. I think it's a multifaceted answer to your question. It's not just one thing.

謝謝，克里斯。感謝這個問題。我認為這是對你的問題的多方面回答。這不僅僅是一件事。

Our objective is to go deep in all of the current accounts that we have. And when I say go deep, I mean, there's a number of initiatives that we're dealing with. First of all, we like to see that they hand out questionnaires very similar to the symptom questionnaire that we provide on our website. So if every patient that walks in the door to urology or urogynecology office gets a questionnaire, then they're going to score themselves immediately. And if they're moderate to severe, it just pops right off the page, then they can get counseled appropriately. I think every single customer that we have doing that, not yet, not everyone, but it's a big initiative at our field force.

我們的目標是深入了解我們擁有的所有經常帳戶。當我說深入時，我的意思是，我們正在處理許多舉措。首先，我們希望看到他們所發放的問卷與我們在網站上提供的症狀問卷非常相似。因此，如果每位走進泌尿科或泌尿婦科診所的患者都會收到一份問卷，那麼他們就會立即為自己評分。如果他們的病情是中度到重度，它就會直接從頁面上彈出，然後他們就可以得到適當的建議。我認為我們的每個客戶都在這樣做，不是現在，不是每個人，但這是我們現場團隊的重大舉措。

The other thing is our clinical specialists spend a lot of time with the office staff, talking about how to move patients more efficiently through the care pathway. And also, once they get an external trial to make sure that they get scheduled efficiently for a permanent implant, right? So that's key.

另一件事是我們的臨床專家花了很多時間與辦公室工作人員討論如何更有效地引導患者通過護理途徑。而且，一旦他們進行外部試驗，以確保他們能夠有效地安排永久植入，對嗎？所以這是關鍵。

DTC, of course, is a part of it, but it's a small part of it because as we have mentioned many times, a lot of the patients are treatment naive, and it takes quite a while for them to work their way through the care pathway. Having said that, as I mentioned in my prepared remarks, we are getting a nice return on that investment today. But here we are, it's October of '23, we started this process back in April of '22, as I recall. So it's taking some time, but it is starting to work.

當然，DTC 是其中的一部分，但它只是其中的一小部分，因為正如我們多次提到的，許多患者都沒有接受過治療，他們需要相當長的時間才能完成護理途徑。話雖如此，正如我在準備好的演講中提到的那樣，我們今天的投資獲得了不錯的回報。但現在是 23 年 10 月，我記得我們早在 22 年 4 月就開始了這個過程。所以這需要一些時間，但它已經開始發揮作用。

So I think that, of course, getting better clinical results and being sure that -- and our customers becoming aware of those results, unlike the way it used to be back in the day before Axonics was in the market, this is another big part of the equation. If physicians are aware that these patients are doing extremely well with our technology, then obviously, they're that much more motivated to talk to the next person about sacral neuromodulation.

所以我認為，當然，獲得更好的臨床結果並確保我們的客戶意識到這些結果，與 Axonics 進入市場之前的情況不同，這是另一個重要部分方程式的。如果醫生意識到這些患者使用我們的技術表現得非常好，那麼顯然，他們就會更有動力與下一個人談論骶神經調節。

And lastly, we -- clearly having Bulkamid as part of the portfolio or armamentarium, also helps us as well. So it's about presence of mind, it's about people thinking about the products that we have to offer. So it's a really good question. But I would tell you a lot of things involved in that. And I mentioned one of the marketing initiatives also is that we do what's called these APP events where we have these nurses coming in. Every month, there's a program someplace in the United States, which is typically attended by about 50 people -- 50 nurses, and they're able to then get insights into what's working in other accounts and things of that nature.

最後，我們顯然將 Bulkamid 作為產品組合或軍備​​庫的一部分，也對我們有幫助。因此，這關乎沉著，關乎人們對我們所提供的產品的思考。所以這是一個非常好的問題。但我會告訴你很多與此相關的事情。我提到行銷舉措之一就是我們舉辦所謂的 APP 活動，讓這些護士進來。每個月，美國某個地方都會有一個項目，通常有大約 50 人參加——50 名護士，然後他們就能夠深入了解其他帳戶中正在運行的內容以及類似性質的內容。

So there's a big, long laundry list of things, Chris, that we're doing. Now I'll just finish by saying, we're thrilled to see this kind of growth from our existing customers and this really gives us the confidence that the market is really growing. It's untapped. And in our hands, it's going to continue to grow. We can't speak to what our competitors are doing or not doing. But in our own hands, it's clear that this gives us a lot of confidence about some of the things we've been saying about the underserved market, the underserved population and the potential to grow this market.

克里斯，我們正在做一長串的事情。最後我想說的是，我們很高興看到現有客戶的這種成長，這確實讓我們有信心市場確實在成長。它尚未開發。在我們手中，它會繼續成長。我們無法談論我們的競爭對手正在做什麼或沒有做什麼。但在我們自己手中，很明顯，這讓我們對我們一直在談論的有關服務不足的市場、服務不足的人口以及該市場成長潛力的一些事情充滿信心。

The next question comes from Larry Biegelsen with Wells Fargo.

下一個問題來自富國銀行的拉里·比格爾森。

Congrats on a nice quarter here. Ray, just at a high level, taking a step back, you're at over 1/3 share now. What are the drivers to market leadership in the U.S. for you? How long do you think it will take? And is there any reason you can't grow SNM revenue by 25% next year?

恭喜您度過了一個愉快的季度。 Ray，只是處於較高水平，退後一步，您現在的份額超過 1/3。對您來說，在美國取得市場領導地位的驅動因素是什麼？您認為需要多長時間？明年 SNM 收入有什麼理由不能成長 25% 嗎？

Thanks, Larry. Appreciate the question. So look, we're not backing off kind of what we've been talking about, in terms of this general notion of 25% Axonics growth in SNM revenue year-over-year and in the neighborhood of 15% growth in the market, right? So we're confident about that and we will continue. And I think if you just run the numbers out, then we're going to get there. I mean, of course, I'd like it to happen sooner than later, but if we get there by the end of 2025, then that would be fantastic, right? So I think everything is moving in the right direction, and we're pleased with the results, and we're just going to keep executing the game plan.

謝謝，拉里。感謝這個問題。所以看，我們並沒有放棄我們一直在談論的事情，就 Axonics SNM 收入同比增長 25% 以及市場增長 15% 左右的一般概念而言，正確的？所以我們對此充滿信心，並將繼續下去。我認為如果你把數字算出來，那麼我們就能實現這個目標。我的意思是，當然，我希望它早點發生，但如果我們在 2025 年底之前實現這一點，那就太棒了，對吧？所以我認為一切都在朝著正確的方向發展，我們對結果感到滿意，我們將繼續執行遊戲計劃。

The next question comes from Travis Steed with Bank of America Securities.

下一個問題來自美國銀行證券公司的 Travis Steed。

Congrats on the margin upside this quarter. And I'll focus my question on the margins. Just curious if you can elaborate on some of the stuff you're doing to get the margin expansion this quarter? And how you can push that into 2024? And then it did sound like you were raising gross margin for Q4, but I don't know if there's any additional color behind that? I think before it was 73% to 74%, and now you're at 74% to 75%.

恭喜本季利潤率上升。我將把我的問題集中在邊緣。只是好奇您是否可以詳細說明您為實現本季利潤率擴張而正在做的一些事情？如何才能將其推遲到 2024 年？然後聽起來你確實提高了第四季度的毛利率，但我不知道這背後是否有任何額外的顏色？我想以前是73%到74%，現在是74%到75%。

Do you want to comment, Kari?

你想發表評論嗎，卡里？

Sure. Travis, Yes, we have had some meaningful improvements to our gross margin as you've stated. We've had and expect to continue to see some choppiness quarter-to-quarter as we're still getting to that even production capacity. At the end of Q2, we had some line of sight to certain yield and supply chain issues. So we had previously guided to 73% to 74% in the second half. We do feel that these items are fairly squared away at this point and have updated the guide to 74% to 75% as you mentioned, for Q4, and we do note that Q3 came in at 74.2%, the high end of that previous guide.

當然。特拉維斯，是的，正如您所說，我們的毛利率得到了一些有意義的改善。我們已經並預計將繼續看到季度與季度之間的一些波動，因為我們仍在達到均勻的生產能力。在第二季末，我們對某些產量和供應鏈問題有了一些了解。所以我們之前下半年指導是73%到74%。我們確實認為這些項目目前已經相當平衡，並且正如您所提到的，第四季度的指南已更新為74% 至75%，而且我們確實注意到第三季的比例為74.2%，這是上一個指南的高端。

So longer term, we do think there's several ways to continue to improve gross margin. We do not think 75% as the cap. And for now, we just need to keep executing. We're finding our process and supply chain have longer production runs and continue to optimize the overall process with expected higher volumes.

因此，從長遠來看，我們確實認為有多種方法可以繼續提高毛利率。我們不認為 75% 是上限。現在，我們只需要繼續執行。我們發現我們的流程和供應鏈的生產運行時間更長，並繼續優化整個流程，預計產量更高。

And EBITDA margins as well?

EBITDA 利潤率也是如此嗎？

Yes. On EBITDA margins, I think this Q3 marks the sixth consecutive quarter of adjusted positive EBITDA. So there's no reason that this trend shouldn't continue. We think that the results are being driven by the natural operating leverage in the business model. For Q4, we made the remark of $79 million for expected OpEx. If you look at adjusted OpEx, meaning just backing out the nonrecurring acquisition-related costs and the onetime acquired IP R&D charge, you can really see there's a steady increase quarter-to-quarter in that adjusted OpEx number.

是的。就 EBITDA 利潤率而言，我認為第三季標誌著調整後的 EBITDA 連續第六個季度為正值。因此，這種趨勢沒有理由不繼續下去。我們認為，結果是由商業模式中的自然營運槓桿所驅動的。對於第四季度，我們預計營運支出為 7900 萬美元。如果您查看調整後的營運支出，即僅扣除與收購相關的非經常性成本和一次性收購的智慧財產權研發費用，您確實可以看到調整後的營運支出數字逐季穩定成長。

So we think that trend will continue. The Q4 OpEx guide is slightly higher. We expect some increased spend in Q4 for higher commissions, more spend on certain marketing initiatives and product development initiatives. But the overall 2023 OpEx number at $280 million is right in line with consensus, which we're comfortable with.

所以我們認為這種趨勢將會持續下去。第四季營運支出指南略高。我們預計第四季度的支出會增加，以提高佣金，在某些行銷計劃和產品開發計劃上支出更多。但 2023 年營運支出總額為 2.8 億美元，完全符合共識，我們對此感到滿意。

The next question comes from Richard Newitter with Truist Securities.

下一個問題來自 Truist Securities 的 Richard Newitter。

Congrats on the quarter. Maybe just following up on the margins here. For 2024, looking ahead, Ray, do you still feel comfortable getting to a 20% plus EBITDA margin? And I'm just wondering if you could give us a sense as to timing or cadence of OpEx as we think out the next couple of quarters, specifically with the fourth quarter, it looks like there's a little bit of deleveraging as I think your applied sales growth is going to grow a little bit below OpEx. I'm just trying to think, should we be thinking about the operating leverage year-over-year disproportionately weighted in any part of the year next year?

恭喜本季。也許只是在這裡跟進。雷，展望 2024 年，您是否仍能輕鬆達到 20% 以上的 EBITDA 利潤率？我只是想知道您是否可以讓我們了解營運支出的時間或節奏，因為我們認為接下來的幾個季度，特別是第四季度，看起來有一點去槓桿化，因為我認為您應用了銷售成長將略低於營運支出。我只是想思考，我們是否應該考慮明年任何時候的營運槓桿比例不成比例的情況？

So look...

所以看...

I can give you some general comments, but we would rather wait to talk about 2024 until we finish Q4. As you know, consensus is $105 million in the quarter in terms of total revenue. So I think we've provided some pretty good inputs that one can riddle out what adjusted EBITDA is going to look like and so forth.

我可以給你一些一般性評論，但我們寧願等到第四季結束後再討論 2024 年。如您所知，就總收入而言，本季的共識是 1.05 億美元。因此，我認為我們已經提供了一些非常好的信息，人們可以透過這些資訊推測調整後的 EBITDA 會是什麼樣子等等。

In terms of cadence for next year, I think we've been very, very clear and really tried to message this beginning earlier this year that Q1 is the softest quarter for a company like Axonics given that our product is an elective -- represents an elective procedure. So we see that Q1 will be the lightest quarter. Q2 is always strong, and then you hope that Q3 is roughly equivalent to what you're able to do in Q2, given that there is momentum in the business, but then you have the holidays to deal with. And then, of course, Q4 is the strongest quarter of the year.

就明年的節奏而言，我認為我們已經非常非常明確地從今年早些時候開始就試圖傳達這樣的訊息：對於像Axonics 這樣的公司來說，第一季是最疲軟的季度，因為我們的產品是一門選修課－代表了選擇性程序。所以我們看到第一季將是最輕的季度。第二季總是很強勁，然後你希望第三季大致相當於你在第二季能夠做的事情，因為業務有動力，但你還有假期要處理。當然，第四季是一年中最強勁的季度。

So that's kind of the way that we've seen it work out the last couple of years, okay? There was a product launch that was a big deal in 2022, that maybe skewed the numbers a bit heavily in a particular quarter. But that's about -- that's the cadence that we expect. And we don't see us slipping back if that's part of the question that you're asking, right? In other words, given the increasing revenue and the ability for us to manage things in terms of our build plan and all the rest of the things that Kari was talking about, I think we're in pretty good shape. But we'd rather wait, if you don't mind, until early next year, likely in the January or February period, and we'll provide solid guidance for 2024 at that time. But I appreciate the question, Richard.

這就是我們過去幾年看到的情況，好嗎？ 2022 年有一項產品發布是一件大事，這可能會嚴重扭曲特定季度的數據。但這就是我們所期望的節奏。如果這是您所問問題的一部分，我們不會看到我們倒退，對吧？換句話說，考慮到收入的增加以及我們根據構建計劃以及卡里談論的所有其他事情進行管理的能力，我認為我們的狀況非常好。但如果您不介意的話，我們寧願等到明年初，可能是 1 月或 2 月期間，屆時我們將為 2024 年提供可靠的指導。但我很欣賞這個問題，理查德。

The next question comes from Adam Maeder with Piper Sandler.

下一個問題來自 Adam Maeder 和 Piper Sandler。

Congrats on the nice quarter. I'm going to maybe go a little bit off script here and ask about the international business and, Ray, specifically the comments on F15. If I look at my sacral neuromodulation model, which admittedly is not perfect, I show the OUS market at a little more than $100 million and I have your market share at roughly mid-single digits internationally. Curious if you could comment on those figures. And with a product like F15 in the market, I mean, how quickly do you think you can go more on the offensive like we've seen here in the United States?

恭喜這個美好的季度。我可能會稍微偏離劇本，詢問國際業務，雷，特別是對 F15 的評論。如果我看一下我的骶神經調節模型（誠然模型並不完美），我會顯示 OUS 市場略高於 1 億美元，而您的國際市場份額大約為中個位數。很好奇您是否可以對這些數字發表評論。對於市場上像 F15 這樣的產品，我的意思是，您認為您能多快採取更多進攻，就像我們在美國看到的那樣？

Yes. Thanks, Adam. I appreciate the question. Look, to start with, you're talking about we have in effect, 10% of the personnel internationally that we have in the United States, right? So I mean we got to kind of start there. I think we're appropriately staffed, considering the modest revenue that we currently have. In order for us to compete and to really grow our business internationally, we need the nonrechargeable SNM product. We need that product approved. With that approval, I think we're in a much better position to compete, honestly, in these various different markets.

是的。謝謝，亞當。我很欣賞這個問題。聽著，首先，你說的是我們實際上擁有美國國際人員的 10%，對嗎？所以我的意思是我們必須從這裡開始。考慮到我們目前的收入微薄，我認為我們的人員配備充足。為了讓我們能夠參與競爭並真正發展我們的國際業務，我們需要不可充電的 SNM 產品。我們需要該產品獲得批准。有了這項批准，我認為我們在這些不同的市場中誠實地競爭處於更好的位置。

I can't -- I don't know what Medtronic's international number is. The only thing that we know was that it represented about 10% of their overall revenue according to public remarks that they made back in 2018 when we were first going public. So as you know, we don't have privy to that information, and I haven't heard any hard numbers.

我不能——我不知道美敦力的國際電話號碼是多少。我們唯一知道的是，根據他們在 2018 年我們首次上市時的公開言論，這約佔他們總收入的 10% 左右。如你所知，我們不了解這些訊息，我也沒有聽到任何確切的數字。

So I don't know if it's as robust as you described. And just to remind people who may not be as aware, the issue internationally is you're dealing primarily with single payer systems who have budgets that don't provide a lot of money for products that are just the quality of life products, right? So that's the issue that there's these caps, whether it's Canada or the U.K. or the Netherlands or other markets we might talk about. Australia is a little more of a laissez-faire market, which is why we're focused now with the direct salespeople -- sales force there, and we're focused on that.

所以我不知道它是否像你描述的那麼強大。只是為了提醒那些可能不那麼意識到的人，國際上的問題是您主要與單一付款人系統打交道，這些系統的預算無法為僅僅是生活品質產品的產品提供大量資金，對嗎？這就是存在這些上限的問題，無論是加拿大、英國、荷蘭或我們可能討論的其他市場。澳洲是一個更自由放任的市場，這就是為什麼我們現在專注於直銷人員——那裡的銷售人員，我們專注於這一點。

So -- but this shouldn't take too much longer, right? I think that's the point I was trying to get across in my remarks, Adam, was that we're down the path, right? We are engaged with these regulatory bodies and we fully expect to get this product approved. There's no showstoppers per say. But things have changed a lot internationally in terms of the MDR requirements and even TGA requirements Down Under.

那麼——但這應該不會花太長時間，對吧？我認為這就是我在演講中試圖表達的觀點，亞當，我們正在走這條路，對嗎？我們正在與這些監管機構合作，我們完全希望該產品能夠獲得批准。沒有什麼好說的。但國際上的 MDR 要求甚至 TGA 要求方面發生了很大變化。

So we're working on it, and hopefully, we will get the approval in our hands in a matter of months as opposed to a longer period of time than that. So -- but you'll see revenue increasing for us once these products get approved internationally. And hopefully, this could become a more measurable part of our SNM business going forward.

所以我們正在努力，希望我們能在幾個月內獲得批准，而不是比這更長的時間。所以，一旦這些產品在國際上獲得批准，您就會看到我們的收入增加。希望這能夠成為我們未來 SNM 業務中更可衡量的一部分。

I appreciate that question, Adam.

我很欣賞這個問題，亞當。

The next question comes from Mike Polark with Wolfe Research.

下一個問題來自 Wolfe Research 的 Mike Polark。

Just on recharge-free versus rechargeable mix in the quarter, the mentions in recent quarters has been like 2/3, 1/3 recharge-free versus rechargeable. Seeing any change there? And I guess, just curious if any new insights as to what patients are preferring in the field?

僅就本季的免充電與可充電混合而言，最近幾季提到的免充電與可充電的比例分別為 2/3、1/3。看到那裡有什麼改變嗎？我想，只是好奇是否有關於患者在該領域更喜歡什麼的新見解？

Thank you, Mike. I appreciate the question. It's interesting that we all would like to attribute whether somebody goes rechargeable and not rechargeable to patient preference. But I would tell you, based upon dozens and dozens of conversations I've had directly with our customers that it's not so much patient preference. It's exactly whatever the doctor guides them to, which determines what they ultimately wind up with. Which is why we try to remind our customers that with the new R20, you're talking about a recharging interval of 1 hour every 6 to 12 months, mean that makes a rechargeable product not rechargeable really because they don't have to do anything. They just schedule the patient back in.

謝謝你，麥克。我很欣賞這個問題。有趣的是，我們都希望將某人是否可以充電或不充電歸因於患者的偏好。但我想告訴你，根據我與客戶直接進行的數十次對話，這並不是病人的偏好。醫生的指導決定了他們最終的結果。這就是為什麼我們試圖提醒我們的客戶，對於新的 R20，您所說的是每 6 至 12 個月充電 1 小時的間隔，這意味著可充電產品實際上無法充電，因為他們不需要做任何事情。他們只是安排病人回來。

(Operator Instructions)

（操作員說明）

Michelle, we're back on. Are you there?

米歇爾，我們回來了。你在嗎？

Yes.

是的。

Okay. So should we go ahead and continue?

好的。那我們應該繼續嗎？

Yes. Mike is still -- his line is still open for questions.

是的。麥克仍然——他的線路仍然有待提問。

Sorry about that. Okay. So Michelle, we're live now again?

對於那個很抱歉。好的。米歇爾，我們又開始直播了嗎？

Yes.

是的。

Okay. All right. Apologies. I think we had a power outage here in Irvine, California. So sorry about that. So Mike's question was about the split between rechargeable and nonrechargeable, and I was just kind of going down the path or explaining that as a company, we're agnostic but it's more about physician preference, it seems to us than patient preference. And the fact that the recharging interval is significantly long and not burdensome for people.

好的。好的。道歉。我想我們在加州歐文市停電了。對此感到非常抱歉。麥克的問題是關於可充電和不可充電之間的區別，我只是沿著這條路走下去或解釋說，作為一家公司，我們是不可知論的，但更多的是關於醫生的偏好，在我們看來，而不是病人的偏好。而且充電間隔時間相當長，對人們來說並不造成負擔。

But nevertheless, it's tough to erase the perceptions that physicians have, but because for 20-something years, the only thing they knew was a nonrechargeable device from our competitor. So -- but the direct answer to your question, Mike, is that it's now about 75% nonrechargeable and about 25% rechargeable. So F15 continues to gain in popularity. Product is working great, people are highly satisfied with the product. And we're okay either way. As long as they're doing business with Axonics, we're happy to get the business regardless of which device they want to implant.

但儘管如此，很難消除醫生的看法，因為二十多年來，他們唯一知道的是我們競爭對手的不可充電設備。所以，麥克，對你的問題的直接回答是，現在大約 75% 是不可充電的，大約 25% 是可充電的。因此F15繼續受到歡迎。產品運作良好，人們對產品非常滿意。不管怎樣我們都可以。只要他們與 Axonics 開展業務，無論他們想要植入哪種設備，我們都很樂意獲得業務。

Our next question comes from Shagun Singh with RBC Capital Markets.

我們的下一個問題來自加拿大皇家銀行資本市場的 Shagun Singh。

I do apologize, his line did disconnect.

我很抱歉，他的線路確實斷開了。

The next question comes from Mike Matson with Needham & Company.

下一個問題來自 Needham & Company 的 Mike Matson。

Yes. Thanks. Great to see the continued strength with Bulkamid. I was just wondering if in terms of the R&D pipeline, is there any opportunity to create enhancements, reformulations of that product? And are there any opportunities for indication expansions or maybe going into additional international markets?

是的。謝謝。很高興看到 Bulkamid 的持續強勢。我只是想知道就研發管道而言，是否有機會對該產品進行增強或重新配製？是否有機會擴大適應症或進入其他國際市場？

So with respect to Bulkamid, we have a pretty robust business internationally, Mike. In fact, I think it was 81% of the Bulkamid revenue? You guys checking me on this number?

因此，就 Bulkamid 而言，我們在國際上擁有相當強勁的業務，麥克。事實上，我認為這是 Bulkamid 收入的 81%？你們用這個號碼查我嗎？

It's 19% international.

其中19%是國際化的。

19% international, so 81% in the United States. So almost 20% of the business in the quarter came from international markets and we're selling in quite a few countries. So that will continue.

19% 來自國際，81% 來自美國。因此，本季近 20% 的業務來自國際市場，我們在相當多的國家/地區進行銷售。所以這將繼續下去。

At the moment, Mike, we got heads down. We're just focused on continued adoption and utilization of Bulkamid. We are -- our pants are not on fire to try to do more things with that product. It's going really well. And I think the key thing for us now is just kind of continuing to get the word out on the product and it's fast becoming first-line therapy for women with stress urinary incontinence. So I think that pretty well answers the question as directly as I can.

麥克，此刻我們都低著頭。我們只專注於 Bulkamid 的持續採用和利用。我們—我們的褲子不會因為嘗試用該產品做更多事情而著火。一切進展順利。我認為現在對我們來說關鍵的事情就是繼續宣傳該產品，它很快就會成為女性壓力性尿失禁的第一線治療方法。所以我認為這很好地盡可能直接地回答了這個問題。

The next question comes from David Rescott with Baird.

下一個問題來自 David Rescott 和 Baird。

Congrats on the strong quarter here. Ray, you -- I think in the prepared remarks, you called out a modest increase in head count heading into 2024. Not necessarily eternally sure where the Street is for next year, but we're kind of in that mid-teens OpEx growth outlook into 2024. I'm just wondering if you could provide any more color on really how you're thinking about or qualifying this modest increase in headcount next year?

恭喜本季的強勁表現。 Ray，你——我想在準備好的發言中，你提到了 2024 年員工人數將適度增加。不一定永遠確定明年的華爾街情況，但我們的運營支出增長處於十幾歲左右展望2024 年。我只是想知道您是否可以提供更多信息，說明您是如何考慮或限定明年員工人數的適度增長？

Well, I would say modest is probably in the neighborhood of 5% or so. I mean if it was 10%, it's not so modest, right? But we're covering literally the entire United States. I mean, we don't have areas of the country where we don't have representation. I mean we even -- maybe Alaska is last remaining state in the union. We have a representative now in Hawaii selling both Bulkamid and sacral neuromodulation. So we've got good coverage -- but we are now doubling down in certain territories around the United States where for one reason or another, our competitor may have more business than we do, that we're not getting our fair share, and those are the markets that we're really looking to invest more in terms of personnel. So we make sure we call on all those folks that are not doing business with us.

嗯，我想說適度可能在 5% 左右。我的意思是，如果是 10%，那也不算太小了，對吧？但我們實際上覆蓋了整個美國。我的意思是，我們在全國所有地區都沒有代表。我的意思是我們甚至——也許阿拉斯加是聯邦中最後一個剩下的州。我們現在在夏威夷有一名代表銷售 Bulkamid 和骶神經調節劑。因此，我們已經獲得了良好的覆蓋範圍，但我們現在正在美國各地的某些地區加倍努力，這些地區出於某種原因，我們的競爭對手可能比我們擁有更多的業務，而我們沒有獲得公平的份額，而這些是我們真正希望在人員方面進行更多投資的市場。因此，我們確保拜訪所有不與我們做生意的人。

So what I would say is that we have very good data at this point. We know exactly who's doing sacral neuromodulation in the United States. We know from third-party billing data how many procedures they're doing. We know a lot of stuff that we just didn't have this information years ago. So we're pretty focused now. And the key thing for us is that we want to bring some bigger users, if you may, people that have higher volume to the party, that really helps move the meter. So I think at this point, considering we're less than -- well, we're almost 4 years now, almost 4 years now commercial in the United States, that I think we've made phenomenal progress during this period of time. And I'm really excited about the next 18 to 24 months and what we can accomplish during that period.

所以我想說的是，我們目前擁有非常好的數據。我們確切地知道誰在美國進行骶神經調節。我們從第三方帳單資料中知道他們正在執行多少程序。我們知道很多我們幾年前沒有的資訊。所以我們現在非常專注。對我們來說，關鍵是我們希望吸引一些更大的用戶，如果可以的話，那些擁有更高音量的人參加聚會，這確實有助於推動進展。所以我認為，考慮到我們在美國商業化不到四年，我認為我們在這段時間取得了驚人的進展。我對未來 18 到 24 個月以及我們在此期間能夠取得的成就感到非常興奮。

The next question comes from Kristen Stewart with CL King.

下一個問題來自克里斯汀·史都華 (Kristen Stewart) 和 CL King。

Congrats on a good quarter. I was wondering if you could just go into a little bit more detail on the new external trialing system. And sorry if I missed this, but any thoughts on timing for that?

恭喜季度表現良好。我想知道您是否可以更詳細地介紹新的外部試用系統。抱歉，如果我錯過了這一點，但是對於時間安排有什麼想法嗎？

So, yes, in terms of timing, we're working diligently to be able to get that filed with the FDA in mid-2024. And assuming standard statutory timeline of the product, hopefully, we'll be in the market by the end of next year. So it does take some time, as you can imagine. The product is now fully developed. But we've got to do all the validation, verification testing and that's required and making the filing. So this is -- the product is designed to eliminate a lot of the cables and things that are being used today, make it much more streamlined, lower profile. And most importantly, we've said this publicly before, the ability for patients to be able to take a shower when they're undergoing that 3-day, typically 3-day, external trial.

所以，是的，就時間而言，我們正在努力工作，以便能夠在 2024 年中期向 FDA 提交申請。假設產品的標準法定時間表，我們希望能在明年年底上市。因此，正如您可以想像的那樣，這確實需要一些時間。該產品現已完全開發完成。但我們必須完成所有必要的驗證、驗證測試並進行備案。所以這就是——該產品的設計目的是消除當今使用的許多電纜和東西，使其更加流線型、低調。最重要的是，我們之前曾公開說過，患者在接受為期 3 天（通常是 3 天）的外部試驗時能夠洗澡。

So I could tell you there's an enormous amount of enthusiasm amongst our customer base who have heard about the new product. And I think the combination of the foramen finder and the new external trial system, I mean, these things in combination should really help. And I think, Kristen, the piece of the puzzle here or the message that we're really trying to get out to not only the investing public and our shareholders, but also to our customers that Axonics is the innovator in this space. We're the ones that are driving the market forward, coming up with new things and trying to make things more streamlined, et cetera, et cetera. And the message that we say to our customers, and I'd say to shareholders, if you're going to bet, bet on Axonics, because we're not stopping. And we're listening very intently to feedback from our customers, and we're nimble enough to be able to react.

所以我可以告訴你，我們的客戶群在聽說了這個新產品後展現了極大的熱情。我認為椎間孔探測器和新的外部試驗系統的結合，我的意思是，這些東西的結合應該確實有幫助。我認為，克里斯汀，這裡的難題或我們真正試圖不僅向投資大眾和我們的股東，而且向我們的客戶傳達的訊息是，Axonics 是這個領域的創新者。我們是推動市場前進的人，提出新事物並努力使事情變得更加精簡，等等。我們對客戶說的訊息，我對股東說的訊息，如果你要下注，就押注 Axonics，因為我們不會停止。我們非常認真地傾聽客戶的回饋，並且我們足夠靈活，能夠做出反應。

And when we talk about one of our key values being thoughtful innovation, that's really where it comes from, right, is listening, asking questions, listening and then taking it under advisement and making the changes. So I think that sacral neuromodulation has undergone a renaissance in our hands. And we will continue to push the envelope forward in terms of making this as easy as possible for caregivers and patients to get the symptom relief that they're looking for.

當我們談論我們的關鍵價值觀之一是深思熟慮的創新時，這確實是它的來源，對吧，就是傾聽，提出問題，傾聽，然後接受建議並做出改變。所以我認為骶神經調節在我們手中經歷了復興。我們將繼續突破極限，讓護理人員和患者盡可能輕鬆地獲得他們想要的症狀緩解。

So I appreciate the question. I draw you a picture, but it's difficult to do live over the phone line, but we'll be having a lot more information about this in the coming year.

所以我很欣賞這個問題。我為你畫了一張圖，但很難透過電話線即時進行，但我們將在來年獲得更多有關此的資訊。

The next question comes from Shagun Singh with RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的 Shagun Singh。

I'm so sorry, I dropped. But, Ray, congratulations on a on a strong quarter, and it does look like you have a lot of momentum going into '24. I was just wondering if you can maybe talk to us about how you think about adjacencies or call points that Axonics could potentially expand into even though there is a lot of runway right now with your current businesses, but you've add Bulkamid, that's turned out really well. Just how do you think of IDNs, does that make sense, urology, women's health? How do you think about it more broadly? And then separately, just how do you think about Axonics strategically? Would you be open to interest from other players?

真抱歉，我掉線了。但是，Ray，祝賀您季度表現強勁，看起來您在進入 24 年時確實有很大的動力。我只是想知道您是否可以與我們談談您如何看待 Axonics 可能擴展到的鄰接點或呼叫點，儘管您當前的業務目前有很多跑道，但您已經添加了 Bulkamid，這就變成了出來真的很好。您如何看待 IDN，這對泌尿科、女性健康有意義嗎？您如何更廣泛地思考這個問題？另外，您如何從戰略角度看待 Axonics？您願意接受其他玩家的興趣嗎？

If I decode the last part of your message, I think you're asking me, would Axonics be open to being acquired by a larger company. I think that's the question. Is that how you heard it, Neil? Okay.

如果我解讀您訊息的最後部分，我想您是在問我，Axonics 是否願意被一家更大的公司收購。我想這就是問題所在。尼爾，你是這麼聽的嗎？好的。

So my answer to that would be Axonics' stock is for sale every minute of every day and people -- we encourage people to buy it. So you can buy a little bit, a lot of bit or the whole bit. And I think that that would be my reaction to that question. I mean none of us are here for lifetime employment. We're here to create shareholder value, that's the game. And so we're certainly open. It's not something we think about. We just focus on the execution of our business.

因此，我對此的回答是 Axonics 的股票每天每時每刻都在出售——我們鼓勵人們購買它。因此，您可以購買一點、很多或全部。我想這就是我對這個問題的反應。我的意思是我們中沒有人是為了終身僱用而來到這裡的。我們來這裡是為了創造股東價值，這就是遊戲。所以我們當然是開放的。這不是我們考慮的事情。我們只專注於我們業務的執行。

The other question you asked is really -- it's really a big question and difficult to kind of get one's arms around it. I mean we are constantly looking at different things. We have a lot of folks coming to us, and they saw that we acquired Bulkamid and we acquired the foramen finder. So we get a lot of inbounds, as you might imagine. Our main focus is the new continence field, and we're trying to stay straight down the fairway with respect to that. So we've been evaluating a number of other potential products that could add to the bag that are strategic in nature, would move the meter. We don't want to fill the bag up with a bunch of miscellaneous stuff, right? That's inexpensive, that doesn't make sense for us. So we're going to be judicious and thoughtful about what we do. And we'll just go from there.

你問的另一個問題確實是——這確實是一個大問題，很難解決。我的意思是我們不斷地關注不同的事物。有很多人來找我們，他們看到我們獲得了 Bulkamid，我們獲得了椎間孔探測器。所以，正如你想像的那樣，我們收到了很多界外球。我們的主要關注點是新的失禁領域，我們正努力在這方面保持直線前進。因此，我們一直在評估許多其他潛在的產品，這些產品可以添加到袋子中，這些產品本質上具有戰略意義，可以提高價格。我們不想讓袋子裝滿一堆雜七雜八的東西，對嗎？這麼便宜，對我們來說沒有意義。因此，我們將對我們所做的事情保持明智和深思熟慮。我們就從那裡開始。

In terms of adjacencies, if that means what else could we do with neurostimulation? I think that we said numerous times that we do not anticipate getting into an adjacent business utilizing neurostimulation as a platform that does not make sense, different call points, different businesses completely. So we're going to stick to our knitting and just kind of stay straight ahead. We got a good business. We have such underappreciated or I should say, untapped market, with a combination between SUI patients who've been differentially diagnosed -- or who have the moderate to severe forms of stress urine incontinence or urgent incontinence patients at the bath time. And these are tens of millions of patients out there. And I think our DTC efforts really underscore the magnitude of this opportunity and so forth.

就鄰接而言，如果這意味著我們還能用神經刺激做什麼？我想我們已經說過很多次了，我們預計不會進入利用神經刺激作為一個沒有意義的平台的相鄰業務，不同的呼叫點，完全不同的業務。因此，我們將堅持我們的編織，並保持直線前進。我們生意很好。我們有這樣一個未被充分認識的市場，或者我應該說，尚未開發的市場，其中包括經過鑑別診斷的 SUI 患者，或患有中度至重度壓力性尿失禁或洗澡時緊急尿失禁的患者。那裡有數千萬患者。我認為我們的 DTC 努力確實強調了這個機會的重要性等等。

And when you run ads on television and you've got over 250,000 people per quarter, and this year, we'll be well over 1 million people coming to our website looking for information at findrealrelief.com. So that, I think, also underscores the fact that this is a really unbelievable market. And I think it would quite frankly, kind of a bit foolish for us to take our eye off the ball. So we're going to continue to go down the path and focus on growing the company, growing it profitably in the years to come. And I do appreciate the question, Shagun.

當您在電視上投放廣告時，每季都會有超過 25 萬人，而今年，將有超過 100 萬人造訪我們的網站 findrealrelief.com 尋找資訊。因此，我認為，這也強調了這樣一個事實：這是一個非常令人難以置信的市場。坦白說，我認為如果我們把注意力從球上移開，那就有點愚蠢了。因此，我們將繼續沿著這條路走下去，專注於發展公司，在未來幾年內獲利。我確實很欣賞這個問題，Shagun。

The next question comes from Anthony Petrone with Mizuho.

下一個問題來自瑞穗的 Anthony Petrone。

Congratulations sharing a strong quarter. A couple just on account penetration, referencing some statistics from last quarter. You mentioned, Ray, last quarter that the highest volume accounts at Axonics are doing about 50 surgeries a year. Just wondering where the average is across the user base and how many can get up to that 50 upper bound let's say, over the next year or so?

恭喜您分享了強勁的季度業績。有些只是關於帳戶滲透率，參考了上個季度的一些統計數據。 Ray，您在上個季度提到 Axonics 的最高交易量客戶每年進行約 50 例手術。只是想知道整個用戶群的平均值在哪裡，以及有多少人可以達到 50 的上限（比如說，在未來一年左右的時間）？

And then the second quick follow-up would be on just Bulkamid synergies here. Got that up to about 20,000 implants as of last quarter. And it certainly seems like there are synergies that are driving, I think, competitor wins, just considering that Medtronic doesn't have it for bags. So how much more runway is there with Bulkamid, just in terms of that procedure being now a bigger option for patients and practices but also potentially a lever to gain share from Medtronic?

然後第二個快速跟進將是關於 Bulkamid 的協同作用。截至上季度，已植入約 20,000 個植入物。我認為，考慮到美敦力（Medtronic）在袋子上沒有這種能力，我認為，似乎確實有協同效應正在推動競爭對手獲勝。那麼，僅就該手術現在成為患者和實踐的更大選擇，而且也有可能成為從美敦力獲得份額的槓桿而言，Bulkamid 還有多少跑道呢？

Yes. Thank you, Anthony. I appreciate your comments. Let me clean something up. I think that either some misinterpretation or a little bit out of context. We have some customers that are doing well over 50 implants a year. So I just want to get that point across. It's -- they're rare. And I think we kind of put them in 3 buckets, quite frankly. One is the -- well, we use the term dabbler bucket. Which is folks that are doing around 1 per month, right? So that's kind of -- there's a lot of those docs out there. I mean any one physician that's doing 1 implant per month, they have the ability to do probably 3x to 5x more than that, with just a teeny little bit of effort, right? So we're continuing to move those physicians up in terms of the volume, which is why we made it a point to talk about the mid- to high teens rate of growth on a per account basis.

是的。謝謝你，安東尼。我很欣賞你的評論。讓我清理一些東西。我覺得要嘛有些誤解，要嘛有點斷章取義。我們的一些客戶每年進行超過 50 次植牙手術。所以我只想讓大家明白這一點。這是——它們很罕見。坦白說，我認為我們將它們分為三個部分。一個是——嗯，我們使用術語“涉水桶”。這些人每個月大約做 1 次，對吧？所以這就是——那裡有很多這樣的文檔。我的意思是，任何一位醫生每月進行 1 次種植手術，他們只需付出一點點努力，就有能力完成大約 3 到 5 倍的工作，對嗎？因此，我們將繼續提高這些醫生的數量，這就是為什麼我們將重點放在每個帳戶中青少年中高成長率的原因。

Obviously, it's easier to get somebody who's doing 12 to turn that into 20 than it is to take somebody who's doing 60 and turn it into 80 or 90, right? So we're aware of that. But we are looking to move the dabblers into the middle category and we are looking obviously to maximize what we can out of high-volume accounts. The key thing for us is to bring some more of those high-volume accounts to Axonics. And if they were a high-volume account, we came into the market. Clearly, our competitor kind of withdrew their forces, if you may, and surrounded the castle to try to keep us out of the bigger high-volume accounts.

顯然，讓一個做 12 的人把它變成 20 比讓一個做 60 的人把它變成 80 或 90 更容易，對吧？所以我們知道這一點。但我們希望將涉足者轉移到中間類別，並且我們顯然希望最大限度地利用大容量帳戶。對我們來說，關鍵是為 Axonics 帶來更多大容量客戶。如果他們是大容量客戶，我們就會進入市場。顯然，我們的競爭對手撤出了他們的部隊（如果可以的話），並包圍了城堡，試圖阻止我們接觸更大的高容量客戶。

Now we've been able to penetrate quite a few of them. But Bulkamid has been the key for us to get into those castles and to get people using Bulkamid and then to play the longer game with them with respect to giving us an opportunity on sacral neuromodulation. So your question was implying or asking whether or not Bulkamid is helping us to gain share and to gain the business from a sacral neuromodulation standpoint. ?And the answer is absolutely without a doubt, no question. We would not be where we are today if we had not made that strategic acquisition and had that product in our line and you're right, it does clearly separate us from Medtronic, who has no other business in urology other than sacral neuromodulation.

現在我們已經能夠滲透其中的相當一部分了。但 Bulkamid 是我們進入這些城堡並讓人們使用 Bulkamid 的關鍵，然後與他們一起玩更長期的遊戲，為我們提供了骶神經調節的機會。所以你的問題是暗示或詢問 Bulkamid 是否正在幫助我們從骶神經調節的角度獲得份額和業務。 ？答案是絕對毫無疑問、毫無疑問的。如果我們沒有進行策略性收購並將該產品納入我們的產品線，我們就不會取得今天的成就，你是對的，它確實將我們與美敦力區分開來，美敦力除了骶神經調節之外在泌尿科沒有其他業務。

So now the good news is that we only have about half of our Bulkamid customers that are doing sacral neuromodulation with Axonics. A bunch of them are doing it with our competitor and some are just doing BOTOX. So we're continuing to work on that. There's a lot of cross-selling initiatives that we're doing as a company as you would imagine. And it's all moving in the right direction. I just think it's just going to take a little more time. It's difficult to displace a competitor who have had a monopoly for 25 years, right? I mean -- and we've talked about the legacy associated with that. So -- but we're moving in the right direction. And I think that the word's out, right? When it comes to sacral neuromodulation, we got the goods. Patients do really, really well with our products. They get great support from our team and so on and so forth. And Bulkamid works like a charm. And it is clearly much easier for a woman who has stress urinary incontinence to say yes to Bulkamid than to a sling procedure as an example. So hopefully, that gave you a pretty open-end answer, Anthony, to your question.

所以現在的好消息是，我們只有大約一半的 Bulkamid 客戶正在使用 Axonics 進行骶神經調節。他們中的一些人正在與我們的競爭對手一起做這件事，有些人只是做肉毒桿菌。所以我們正在繼續努力。正如您所想像的那樣，我們作為一家公司正在採取許多交叉銷售舉措。一切都在朝著正確的方向發展。我只是覺得這還需要多一點時間。想要取代一個已經壟斷了25年的競爭對手是很困難的，對吧？我的意思是——我們已經討論了與此相關的遺產。所以——但我們正朝著正確的方向前進。我想這話已經說完了，對吧？當談到骶神經調節時，我們得到了好處。患者對我們的產品的使用效果非常非常好。他們得到了我們團隊的大力支持等等。 Bulkamid 的作用就像一個魅力。對於患有壓力性尿失禁的女性來說，接受 Bulkamid 顯然比接受吊帶手術要容易得多。安東尼，希望這能為你的問題提供一個非常開放的答案。

The next question comes from Kallum Titchmarsh with Morgan Stanley.

下一個問題來自摩根士丹利的卡勒姆·蒂奇馬什。

Just on the DTC campaign, some interesting comments there. I'm wondering whether there's been certain respondent demographics or populations that have surprised you. Anything that's varied from a typical patient type you've seen receive an SNM treatment across the years? I mean given the goal of these campaigns is the spread awareness, I wanted to see whether you've seen anything different in patient mix since commencing the ads?

就 DTC 活動而言，有一些有趣的評論。我想知道是否有某些受訪者的人口統計或人群令您感到驚訝。多年來您所見過的接受 SNM 治療的典型患者類型有何不同？我的意思是，鑑於這些活動的目標是傳播意識，我想看看自廣告開始以來，您是否發現患者組合有什麼不同？

Thank you for the question. I wouldn't say that there's anything different about the people responding from -- to DTC from the actual patient demographics of who we're actually implanting. I would say it's pretty consistent. I think the only difference is that we have more men responding to DTC than actually we have as percentages of our customers that get an implant. As it turns out maybe 25% of the people inquiring are men, but in terms of actual implants, it's less than 15% or somewhere around that number. So that would be the only thing I'd call out.

感謝你的提問。我不會說人們對 DTC 的反應與我們實際植入的實際患者人口統計有什麼不同。我想說這是非常一致的。我認為唯一的區別是，我們對 DTC 做出反應的男性數量比實際接受植入手術的客戶百分比要多。事實證明，詢問的人中可能有 25% 是男性，但就實際植入情況而言，這一數字不到 15% 或大約在這個數字左右。所以這將是我唯一要指出的事情。

I think it's going to be really interesting now starting this month actually. We will have the first bowel dysfunction or fecal incontinence commercial that will be running with a gentleman who is a patient who talks about him having had both urinary and fecal incontinence and how Axonics has -- Axonics' therapy has really changed his life. So it will be interesting to see, and we very specifically picked a man to do that particular commercial.

我認為從本月開始實際上會變得非常有趣。我們將製作第一個腸道功能障礙或大便失禁廣告，由一位紳士播放，他是一位病人，他談論自己患有尿失禁和大便失禁，以及 Axonics 的治療如何真正改變了他的生活。所以這會很有趣，我們非常特別地挑選了一個人來製作這個特定的廣告。

Now we also have a woman who also has the same dual incontinence symptoms. And we're running that commercial as well. So this November we have, for the first time, stress urinary incontinence commercial. We have a dual incontinence commercial where people are talking about urinary and fecal incontinence at the same time. And in addition to the kind of straightforward more generic OAB ads.

現在我們還有一位女性也有同樣的雙重失禁症狀。我們也正在播放該廣告。今年 11 月，我們首次推出了壓力性尿失禁廣告。我們有一個雙重失禁廣告，人們同時談論尿失禁和大便失禁。除了那種簡單的、更通用的 OAB 廣告。

So you can see that we're trying to get to your question in a way. I mean we're going to -- we're changing up the messaging and seeing what kind of response we get is maybe different than what we've seen so far. But I think it was time for us to be a little more specific with some of these symptoms and see if we can draw some people in. We're really curious to see how the fecal incontinence add draws. Because talk about people being embarrassed. I mean it's one thing to talk about urinary dysfunction, it's really embarrassing to talk about fecal dysfunction.

所以你可以看到我們正在嘗試以某種方式回答你的問題。我的意思是，我們將改變訊息傳遞方式，看看我們得到的回應可能與我們迄今為止所看到的不同。但我認為現在是時候對其中一些症狀進行更具體的說明，看看是否可以吸引一些人參與其中。我們真的很好奇大便失禁會如何吸引人。因為談論人們會感到尷尬。我的意思是，談論泌尿功能障礙是一回事，談論糞便功能障礙確實很尷尬。

So we do know that about 30% or so of the patients that actually get sacral neuromodulation for urinary urge incontinence have some form of fecal incontinence to go along with it. So if we can draw some of those people in presenting with fecal continence as their primary indication, it will be really interesting to see how that impacts our business in general. So that's kind of what we're up to. But the demographic and why are we on television, right?

所以我們確實知道，大約 30% 左右的實際上接受骶神經調節治療急迫性尿失禁的患者會伴隨某種形式的大便失禁。因此，如果我們能吸引其中一些人以大便失禁作為他們的主要適應症，那麼看看這對我們的整體業務有何影響將是非常有趣的。這就是我們要做的。但是人口統計以及我們為什麼上電視，對嗎？

Well, we're on television because if you look at third-party SaaS, you'll find that it's the people 60 years or older, are the ones that are watching network television these days. And that's why we're on television because that's our demographic that we're after. The average age of a person getting sacral neuromodulation for Axonics is 58 years old. So that's the case. We've tried some streaming services and some other fancy stuff in the past and it just doesn't pull as well. As just plain vanilla Facebook and obviously a network television. So that's the story.

好吧，我們上電視是因為如果你看看第三方 SaaS，你會發現現在觀看網路電視的都是 60 歲或以上的人。這就是我們上電視的原因，因為這就是我們所追求的人群。接受 Axonics 骶神經調節的人的平均年齡是 58 歲。就是這樣。我們過去嘗試過一些串流媒體服務和其他一些奇特的東西，但效果不佳。就像普通的 Facebook 和網路電視一樣。這就是故事。

The next question comes from Michael Sarcone with Jefferies.

下一個問題來自傑弗里斯的邁克爾·薩爾科內。

Just a quick question. Can you just talk about, in the U.S., what does rep productivity look like on average? And kind of where do you think that could ultimately go?

只是一個簡單的問題。您能談談在美國，銷售代表的平均生產力是怎麼樣的嗎？您認為最終會走向何方？

That's a good question. So we talked publicly early day that when we looked at the headcount of our competitor for sacral neuromodulation, their average productivity per rep was about $3.5 million. Now that was with a monopoly with no competition. This year, in 2023, we expect average productivity to be a little over $2.5 million on a per rep basis. And we would expect, obviously, nice increases consistent with what we're guiding in terms of our growth trajectory in 2024. So you could imagine, once again, not even finished our fourth year and to see the productivity to be as high as it is, we're very encouraged by that. So that's the answer to your question. I think you got to round it up higher, obviously, for 2024, but that's what we're looking at.

這是個好問題。因此，我們很早就公開表示，當我們查看骶神經調節競爭對手的員工人數時，他們每個代表的平均生產力約為 350 萬美元。現在是壟斷，沒有競爭。今年，也就是 2023 年，我們預計每位代表的平均生產力將略高於 250 萬美元。顯然，我們預計，成長將與我們在 2024 年的成長軌跡中所指導的一致。因此，您可以再次想像，我們的第四年還沒有結束，生產力就已經達到瞭如此高的水平是的，我們對此感到非常鼓舞。這就是你問題的答案。顯然，我認為 2024 年你必須將其四捨五入得更高，但這就是我們正在考慮的。

The next question comes from Mike Kratky with Leerink Partners.

下一個問題來自 Leerink Partners 的 Mike Kratky。

So are your newly implemented DTC efforts and the new television commercials likely initiatives that you expect to continue throughout or potentially accelerate in 2024? And then just as a quick follow-up, how do you kind of balance the trade-offs in that DTC spending versus committing to more meaningful investment at the headcount side?

那麼，您新實施的 DTC 工作和新電視廣告是否可能是您預計在 2024 年持續或可能加速的舉措？接下來，您如何平衡 DTC 支出與致力於在員工數量方面進行更有意義的投資之間的權衡？

Well, I think they're mutually exclusive, quite frankly. We're -- once again, we're not looking at DTC as a driver of our business. We kind of look at it like that's the icing on top, right? And we're playing the long game. The DTC is about playing the long game for us, really counterprogramming messages that people are hearing on television that are ads that are suggesting it's normal to leak urine. And if you just take my pill or where my panties or whatever or adult diapers or whatever it is, then everything is great. So we're the company that's doing the counter programming.

嗯，坦白說，我認為它們是相互排斥的。我們再次強調，我們並不將 DTC 視為我們業務的驅動力。我們看它就像是錦上添花，對吧？我們正在打一場持久戰。 DTC 是為我們打一場持久戰，真正反編程人們在電視上聽到的暗示漏尿是正常現象的廣告訊息。如果你只是服用我的藥丸或我的內褲或其他任何東西或成人尿布或其他任何東西，那麼一切都很棒。所以我們是進行計數器編程的公司。

But I want to emphasize that DTC is not the driver of our business. It's all the other initiatives that we've talked about and some of which I mentioned in the script today, that are really driving the business. Now having said that, our customers really appreciate the fact that we're on the airways and that we're providing these messages to folks and some of the -- some of this is going to be difficult to measure, right? There's additional benefit where not everybody is going to fill out a symptom questionnaire. Not everybody is going to go to the website. Some of them just walk right into these offices and say, asking about Axonics -- asking about Axonics therapy. Now of course, when they walk into a customer location that doesn't offer Axonics and they go tell me about Axonics therapy, they go, "Yes, we got that, too. It's called InterStim right?" I'm still waiting for the thank you card from our competitor for doing national television, but that hasn't been forthcoming. So in any event, hopefully, that gives you a reasonably colorful answer to your question.

但我想強調的是，DTC 並不是我們業務的驅動力。真正推動業務發展的是我們討論過的所有其他舉措以及我今天在腳本中提到的一些舉措。話雖如此，我們的客戶確實很欣賞我們在航空公司上提供這些信息，以及我們向人們提供這些信息，其中一些信息將很難衡量，對嗎？並非每個人都會填寫症狀問卷，這還有一個額外的好處。不是每個人都會造訪該網站。他們中的一些人直接走進這些辦公室並說，詢問 Axonics——詢問 Axonics 療法。當然，現在，當他們走進不提供 Axonics 的客戶地點並告訴我有關 Axonics 療法時，他們會說：“是的，我們也有這種療法。它叫做 InterStim，對嗎？”我仍在等待我們的競爭對手寄來的感謝卡，感謝您在全國電視節目中的表現，但還沒有收到。因此，無論如何，希望這能為您的問題提供一個相當豐富多彩的答案。

I show no further questions at this time. I would now like to turn the call back to Raymond Cohen for closing your remarks.

我目前沒有提出任何進一步的問題。現在我想將電話轉回給雷蒙德·科恩，請他結束演講。

Thank you, operator. I appreciate your help today.

謝謝你，接線生。我很感謝你今天的幫忙。

So in closing, I'd like to say that our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, raising awareness of our best-in-class therapies and we're confident that Axonics will continue to grow rapidly and profitably in the years ahead as we continue to expand and penetrate the underserved and undertreated incontinence markets in which we participate.

因此，最後，我想說，我們以使命為導向的團隊仍然致力於創新，支持我們敬業的醫生客戶及其患者，提高對我們一流療法的認識，我們相信 Axonics 將繼續隨著我們繼續擴大和滲透我們參與的服務不足和治療不足的失禁市場，我們將在未來幾年內實現快速成長和獲利。

We remain grateful for the trust physicians, patients and shareholders have placed in Axonics. And as always, I would like to thank my colleagues in Irvine and our team in the field for our diligent efforts -- for their diligent efforts and dedication to fulfilling the Axonics' mission of improving the lives of adults with incontinence.

我們仍然感謝醫生、病人和股東對 Axonics 的信任。像往常一樣，我要感謝我在爾灣的同事以及我們在該領域的團隊的辛勤努力，感謝他們為實現 Axonics 改善失禁成人生活的使命而付出的辛勤努力和奉獻精神。

So thank you so much for the call today. Appreciate all the questions from the analyst community, and we look forward to seeing and speaking with you in the weeks and months ahead.

非常感謝您今天的來電。感謝分析師社群提出的所有問題，我們期待在未來幾週和幾個月內與您見面並交談。

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great afternoon.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。各位，度過一個愉快的下午。