Inspire Medical Systems Inc (INSP) 2024 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon. My name is Dulueem, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Inspire Medical Systems third-quarter 2024 conference call. (Operator Instructions)

    午安.我叫 Dulueem,今天我將擔任你們的會議操作員。現在,我歡迎大家參加 Inspire Medical Systems 2024 年第三季電話會議。(操作員說明)

  • I'll now hand the call over to your first speaker, Ezgi Yagci, the Vice President of Investor Relations at Inspire. You may begin the conference.

    現在我將把電話交給第一位發言人,Inspire 投資者關係副總裁 Ezgi Yagci。您可以開始會議了。

  • Ezgi Yagci - Vice President of Investor Relations

    Ezgi Yagci - Vice President of Investor Relations

  • Thank you, Dulueem, and thank you all for participating in today's call. Joining me are Tim Herbert, Chairman and Chief Executive Officer; and Rick Buchholz, Chief Financial Officer. Earlier today, we released financial results for the three and nine months ended September 30, 2024. A copy of the press release is available on our website.

    謝謝杜盧埃姆,也謝謝大家參加今天的電話會議。與我一起的還有董事長兼執行長 Tim Herbert;和財務長 Rick Buchholz。今天早些時候,我們發布了截至 2024 年 9 月 30 日的三個月和九個月的財務表現。我們的網站上提供了新聞稿的副本。

  • On this call, management will make forward-looking statements within the meaning of the federal securities laws. All forward-looking statements, including, without limitation, those relating to our operations, financial results and financial condition, investments in our business, full-year 2024 financial and operational outlook, and changes in market access are based upon our current estimates and various assumptions.

    在這次電話會議上,管理階層將做出聯邦證券法意義內的前瞻性聲明。所有前瞻性陳述,包括但不限於與我們的營運、財務表現和財務狀況、對我們業務的投資、2024 年全年財務和營運前景以及市場准入變化相關的陳述,均基於我們當前的估計和各種假設。

  • These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. Please see our filings with the Securities and Exchange Commission, including our Form 10-Q, which we filed with the SEC earlier this afternoon for a description of these risks and uncertainties.

    這些陳述涉及重大風險和不確定性,可能導致實際結果或事件有重大差異。因此,您不應過度依賴這些陳述。請參閱我們向美國證券交易委員會提交的文件,包括我們今天下午早些時候向 SEC 提交的 10-Q 表格,其中描述了這些風險和不確定性。

  • Inspire disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, November 4, 2024.

    除法律要求外,Inspire 不承擔任何更新或修改任何財務預測或前瞻性聲明的意圖或義務,無論是由於新資訊、未來事件或其他原因。本次電話會議包含時效性訊息,僅在今天(2024 年 11 月 4 日)直播時發言。

  • With that, it is my pleasure to turn the call over to Tim Herbert. Tim?

    至此,我很高興將電話轉給提姆·赫伯特。提姆?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Ezgi, and thanks, everyone, for joining our business update call for the third quarter of 2024. Let's start with what is most important and that is the delivery of safe and effective therapy to our patients. And as of this call, we have surpassed 85,000 patients who have received Inspire therapy. To ensure ongoing improvements in our system-level performance, we must continually monitor patient outcomes and invest in technology and programs to further advance Inspire therapy, including the annual publication of our patient experience report, which is available on our website.

    謝謝 Ezgi,也謝謝大家參加我們 2024 年第三季的業務更新電話會議。讓我們從最重要的事情開始,那就是為我們的患者提供安全有效的治療。截至本次電話會議,我們已經有超過 85,000 名患者接受了 Inspire 療法。為了確保我們系統級性能的持續改進,我們必須持續監測患者的治療結果,並投資於技術和項目以進一步推進 Inspire 治療,包括每年發布患者體驗報告(可在我們的網站上取得)。

  • Today, I would like to announce a recent peer reviewed publication in the Journal of Clinical Sleep Medicine that reviewed the real-world experience with Inspire since the original FDA approval in 2014. The investigators led by Dr. Colin Huntley at Thomas Jefferson University reviewed data from over 20,000 patients showing a continued improvement in patient safety as documented by reviewing individual site experience as well as FDA and company databases.

    今天,我想宣布《臨床睡眠醫學雜誌》最近發表了一篇經過同行評審的出版物,該出版物回顧了自 2014 年 FDA 最初批准以來 Inspire 的實際使用經驗。由托馬斯傑斐遜大學 Colin Huntley 博士領導的研究人員審查了 20,000 多名患者的數據,透過審查各個現場經驗以及 FDA 和公司資料庫記錄,患者安全性持續改善。

  • In fact, within the first year after implant, explant rates have been shown to be less than 0.7% and revision rates reported as 1.5%, which are both significant improvements from the originally reported STAR trial. These new data set the bar on what is expected from hypoglossal nerve stimulation in the treatment of obstructive sleep apnea. This strong data translates into our business performance, and we are proud to report a successful third quarter.

    事實上,在植入後的第一年內,外植體率已低於 0.7%,翻修率報告為 1.5%,這均較最初報告的 STAR 試驗有顯著改善。這些新數據為舌下神經刺激治療阻塞性睡眠呼吸中止症的預期效果設定了標準。這些強勁的數據轉化為我們的業務績效,我們很自豪地報告第三季的成功。

  • In the third quarter, we generated revenue of $203.2 million, representing a 33% increase compared to the third quarter of 2023. Third-quarter US revenue totaled $195.8 million, also a 33% increase over the same period last year. This revenue growth reflects greater therapy adoption primarily as a result of increased market penetration in existing centers as well as expansion into 66 new implanting centers in the United States and 13 new US sales territories. We now have 1,371 active US centers and 323 US sales territories. Utilization by account increased year over year and is consistent with the second quarter of 2024.

    第三季度,我們營收 2.032 億美元,較 2023 年第三季成長 33%。第三季美國營收總計1.958億美元,也較去年同期成長33%。這項收入成長反映了治療採用率的提高,主要是由於現有中心的市場滲透率提高以及在美國擴展到 66 個新的植入中心和 13 個新的美國銷售地區。我們現在在美國擁有 1,371 個活躍中心和 323 個美國銷售地區。按帳戶劃分的利用率年增,與 2024 年第二季一致。

  • Outside of the US, revenue increased 27% over the same period last year to $7.4 million. We saw strength in Germany, Switzerland, the Netherlands, and Belgium, and we began reimbursed procedures in France. We are increasing our 2024 revenue guidance to $793 million to $798 million, which represents 27% to 28% growth over 2023 revenue of $625 million. This updated guidance reflects some revenue headwinds as a result of the hurricanes and related IV solution shortage impacts in the fourth quarter.

    美國以外地區的營收較去年同期成長 27%,達到 740 萬美元。我們看到了德國、瑞士、荷蘭和比利時的實力,並開始在法國進行報銷程序。我們將 2024 年營收指引提高至 7.93 億美元至 7.98 億美元,比 2023 年 6.25 億美元的營收成長 27% 至 28%。這項更新的指引反映了由於第四季度颶風和相關 IV 解決方案短缺影響而造成的一些收入阻力。

  • Net income for the third quarter was $18.5 million compared to a net loss of $8.5 million in the prior-year period, representing net income of $0.60 per share compared to a net loss of $0.29 per share in the third quarter of 2023. Given the strong performance we have seen year to date, we are raising the full-year earnings per share guidance to $1.20 to $1.40.

    第三季淨利為 1,850 萬美元,而上年同期淨虧損為 850 萬美元,每股淨利為 0.60 美元,而 2023 年第三季每股淨虧損為 0.29 美元。鑑於我們今年迄今的強勁表現,我們將全年每股收益指引上調至 1.20 美元至 1.40 美元。

  • Highlighting a few key team accomplishments. In September, we attended the American Academy of Otolaryngology and the International Sleep Surgical Society conferences in Miami. Inspire had a fantastic conference, including symposia led by exceptional faculty, highlighting 10 years since FDA approval and how the Inspire care pathway leads to excellent outcomes in both academic and private practice settings.

    強調團隊的一些關鍵成就。九月,我們參加了在邁阿密舉行的美國耳鼻喉科學會和國際睡眠外科學會會議。Inspire 舉辦了一場精彩的會議,包括由傑出教師主持的研討會,重點介紹了 FDA 批准以來的 10 週年,以及 Inspire 護理途徑如何在學術和私人診所環境中取得優異的成果。

  • The investigators highlighted that Inspire is a proven therapy with significant and consistent outcomes demonstrated in over 300 publications and over 85,000 patients treated, resulting in coverage policies from Medicare and virtually all private plans. The presentations highlighted Inspire's commitment with an established national team of trusted Inspire professionals focused on patient outcomes in our easy-to-use SleepSync™ system.

    研究人員強調,Inspire 是一種經過驗證的療法,其顯著且一致的結果已在300 多份出版物和超過85,000 名接受治療的患者中得到證明,從而產生了Medicare 和幾乎所有私人計劃的承保政策。這些演講強調了 Inspire 與值得信賴的 Inspire 專業人士組成的國家團隊的承諾,該團隊專注於我們易於使用的 SleepSync™ 系統中的患者治療結果。

  • During these meetings, the investigators also presented data on the PREDICTOR study. As a reminder, the initial focus of the PREDICTOR study is to identify patients who may qualify for Inspire therapy without requiring a drug-induced sleep endoscopy procedure. The data presented focused on patients with a BMI lower than 32, which are those without significant lateral wall collapse that is a key component of complete concentric class. We will continue to discuss this data with physicians and payers to streamline the patient journey to receive Inspire therapy.

    在這些會議期間,研究人員也提供了 PREDICTOR 研究的數據。提醒一下,PREDICTOR 研究的最初重點是確定哪些患者可能有資格接受 Inspire 治療,而不需要藥物誘導的睡眠內視鏡檢查程序。所提供的數據主要針對 BMI 低於 32 的患者,這些患者沒有明顯的側壁塌陷,這是完全同心類的關鍵組成部分。我們將繼續與醫生和付款人討論這些數據,以簡化患者接受 Inspire 治療的過程。

  • On the market access front, we are pleased with the final 2025 national Medicare outpatient payment rates for CPT code 64582, which calls for a slight increase to both the hospital outpatient rate to $30,474 and the ambulatory surgical center rate to $25,832. The final physician fee schedule for 2025 is consistent with the 2024 Medicare physician fee at $816.

    在市場准入方面,我們對2025 年CPT 代碼64582 的最終國家醫療保險門診付款費率感到滿意,該費率要求將醫院門診費率小幅提高至30,474 美元,將門診手術中心費率小幅提高至25,832美元。2025 年的最終醫生費用表與 2024 年 Medicare 醫生費用 816 美元一致。

  • With respect to our market development activities, we continue to advance our medical education programs. And year to date, we have hosted over 250 advanced practice providers at Inspire training programs with another 70 registered for training before year-end. The primary focus of this initiative is to improve capacity in both sleep and ENT clinics to meet the strong patient demand we continue to see for Inspire therapy. Further, we continue to increase our presence at primary care and cardiology conferences to drive increased awareness of Inspire therapy.

    在我們的市場開發活動方面,我們繼續推進我們的醫學教育計劃。今年迄今為止,我們已接待了超過 250 名高級實踐提供者參加 Inspire 培訓計劃,另有 70 名提供者在年底前註冊參加培訓。該計劃的主要重點是提高睡眠和耳鼻喉科診所的能力,以滿足我們持續看到的患者對 Inspire 療法的強烈需求。此外,我們繼續增加在初級保健和心臟病學會議上的參與,以提高對 Inspire 療法的認識。

  • Our direct-to-consumer program remains strong and provides a pathway for patients to connect with the proper healthcare providers. In the third quarter, we continued to see operating leverage in our DTC expenses as we found ways to be more targeted and efficient in our digital advertising, which we believe has contributed to a significant increase in digital patient engagement at a lower cost. Going forward, we will continue to evaluate our DTC programs with the goal of enhancing patient awareness regarding Inspire therapy.

    我們的直接面向消費者的計劃仍然很強大,並為患者提供了與適當的醫療保健提供者聯繫的途徑。第三季度,我們繼續看到 DTC 支出的營運槓桿,因為我們找到了更有針對性和更有效率的數位廣告方法,我們相信這有助於以更低的成本顯著增加數位患者的參與度。展望未來,我們將繼續評估我們的 DTC 計劃,目標是提高患者對 Inspire 療法的認識。

  • We continue to advance initiatives to improve the patient experience. And one example is that we now have over 250 centers using digital scheduling to book patient appointments. With digital scheduling, the patient's ability to schedule an appointment on their first attempt is increased greatly improving the patient's journey to receive Inspire therapy.

    我們持續推動改善患者體驗的措施。一個例子是,我們現在有超過 250 個中心使用數位調度來預約患者。透過數位化安排,患者在第一次嘗試時安排預約的能力得到提高,大大改善了患者接受 Inspire 治療的旅程。

  • Switching to product development. We have begun the soft launch of our new SleepSync(TM) programming system designed to increase the efficiency of Inspire patient management with greater accessibility and a comprehensive view of therapy history. Early feedback is promising, and we expect full U.S. availability this year, enhancing capacity for patient follow-ups and improving experiences for patients and providers.

    轉向產品開發。我們已經開始軟啟動新的 SleepSync(TM) 編程系統,該系統旨在透過更方便的訪問和全面的治療歷史視圖來提高 Inspire 患者管理的效率。早期回饋是有希望的,我們預計今年在美國全面可用,從而增強患者追蹤能力並改善患者和提供者的體驗。

  • As you know, in August, we received FDA approval for the Inspire V neurostimulation system. We are focused on operational readiness and building sufficient inventory, and we remain on track for a soft launch in late 2024 and a full launch in 2025. Inspire V incorporates respiratory sensing capabilities into the neurostimulator, eliminating the need to implant the pressure sensing lead. We believe this will provide benefits to the patient with one fewer component to the physician with reduced surgical time and to the company with reduced production, complexity, and cost.

    如您所知,8 月份,我們的 Inspire V 神經刺激系統已獲得 FDA 批准。我們專注於營運準備和建立足夠的庫存,我們仍有望在 2024 年底進行軟啟動,並在 2025 年全面啟動。Inspire V 將呼吸感測功能融入神經刺激器中,無需植入壓力感測導線。我們相信,這將為患者帶來好處,減少組件的數量,為醫生帶來好處,減少手術時間,為公司帶來好處,降低產量、複雜性和成本。

  • We continue to validate the coding scenarios with payers and Medicare contractors to help ensure we are prepared for the full launch in 2025. We expect to provide more color on our coding strategy in early 2025 once we finalize discussions with the payers. With the final OPPS rules released last week, we have set the pricing for Inspire V system to be consistent with the current Inspire IV system.

    我們繼續與付款人和醫療保險承包商驗證編碼場景,以幫助確保我們為 2025 年的全面啟動做好準備。一旦我們完成與付款人的討論,我們預計將在 2025 年初為我們的編碼策略提供更多資訊。隨著上週發布的最終 OPPS 規則,我們已將 Inspire V 系統的定價與目前的 Inspire IV 系統保持一致。

  • In summary, we remain focused on the patient to continue the growth and adoption of Inspire therapy. We will execute our growth strategy of driving higher-quality patient flow and increasing the capacity of our provider partners to effectively treat and manage more patients. Our key strategies include adding advanced practice providers, training and adding new implanters, increasing center independence, and driving the adoption of SleepSync(TM) and our digital tools, all of which our embedded strategies and our commercial team's objective to increase provider capacity.

    總之,我們仍然以患者為中心,以繼續 Inspire 療法的發展和採用。我們將執行我們的成長策略,推動更高品質的患者流動,並提高我們的提供者合作夥伴有效治療和管理更多患者的能力。我們的關鍵策略包括增加高級實踐提供者、培訓和增加新的植入者、提高中心獨立性以及推動SleepSync(TM) 和我們的數位工具的採用,所有這些都是我們的嵌入式策略和商業團隊的目標,以提高提供者的能力。

  • Looking ahead, we remain excited about our future and are confident that we have the appropriate strategy in place to drive long-term stakeholder value.

    展望未來,我們仍然對未來感到興奮,並相信我們制定了適當的策略來推動利害關係人的長期價值。

  • With that, I'd like to turn the call over to Rick for his review of our financials.

    說到這裡,我想把電話轉給里克,請他審查我們的財務狀況。

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Thank you, Tim, and good afternoon, everyone. Total revenue for the quarter was $203.2 million, a 33% increase from the $153.3 million generated in the third quarter of 2023. US revenue in the quarter was $195.8 million, an increase of 33% from the $147.5 million in the prior-year period. Revenue outside the US was $7.4 million, which was a 27% increase year over year. Gross margin in the quarter was 84.1%, consistent with the prior-year period.

    謝謝蒂姆,大家下午好。該季度總營收為 2.032 億美元,比 2023 年第三季的 1.533 億美元成長 33%。該季度美國營收為 1.958 億美元,較上年同期的 1.475 億美元成長 33%。美國以外的收入為 740 萬美元,年增 27%。該季度毛利率為 84.1%,與去年同期持平。

  • Total operating expenses for the quarter were $156.5 million, an increase of 10% as compared to $142.4 million in the third quarter of 2023. This planned increase was primarily due to the expansion of our sales organization and increased general corporate costs, partially offset by a $3.1 million decrease in R&D expenses and a $2.2 million decrease in DTC expenses year over year.

    該季度的總營運費用為 1.565 億美元,較 2023 年第三季的 1.424 億美元成長 10%。這項計畫成長主要是由於我們銷售組織的擴張和一般公司成本的增加,但部分被研發費用減少 310 萬美元和 DTC 費用年減 220 萬美元所抵銷。

  • Interest and dividend income totaled $5.9 million in the quarter compared to $5.5 million in the prior-year period. This higher income was primarily driven by higher cash and investment balances compared to a year ago. Operating income for the quarter totaled $14.3 million compared to an operating loss of $13.5 million in the prior-year period. Net income for the quarter was $18.5 million compared to a net loss of $8.5 million in the prior-year period, representing net income per share of $0.60 compared to a net loss per share of $0.29 in the third quarter of 2023.

    本季利息和股息收入總計 590 萬美元,而去年同期為 550 萬美元。收入增加主要是由於現金和投資餘額較上年同期增加所致。本季營業收入總計 1,430 萬美元,而上年同期營業虧損為 1,350 萬美元。本季淨利為 1,850 萬美元,而上年同期淨虧損為 850 萬美元,每股淨收益為 0.60 美元,而 2023 年第三季每股淨虧損為 0.29 美元。

  • The weighted average number of diluted shares outstanding in the quarter was 30.6 million. Excluding the impact of any share repurchases that we may complete over the remainder of 2024, we expect the full-year diluted shares outstanding to be approximately 30.6 million to 30.7 million.

    本季稀釋後流通股數的加權平均數為 3,060 萬股。排除我們可能在 2024 年剩餘時間內完成的任何股票回購的影響,我們預計全年稀釋後的已發行股票約為 3060 萬至 3070 萬股。

  • We are excited to announce we generated $52 million in operating cash flow during the third quarter, bringing the year-to-date total to $61 million and increasing our total cash and investment balances to $524 million at September 30. This strong cash position allows us to remain focused on executing our growth strategies.

    我們很高興地宣布,第三季我們產生了5,200 萬美元的營運現金流,使年初至今的現金流總額達到6,100 萬美元,並將截至9 月30 日的現金和投資餘額總額增加到5.24 億美元。強大的現金狀況使我們能夠繼續專注於執行我們的成長策略。

  • Moving on to 2024 guidance. We now expect full-year revenue to be in the range of $793 million to $798 million, representing an increase of 27% to 28% compared to full-year 2023 revenue, and we continue to expect full-year gross margin to be in the range of 83% to 85%. We also continue to expect to activate 52 to 56 new US centers and establish 12 to 14 new US sales territories during the remaining quarter of 2024. Given the strong momentum in our business and our improving operating leverage, we now expect diluted net income for the full year 2024 will be between $1.20 and $1.40 per share.

    轉向 2024 年指導。我們目前預計全年營收將在 7.93 億美元至 7.98 億美元之間,較 2023 年全年營收成長 27% 至 28%,並且我們繼續預計全年毛利率將在範圍為 83% 至 85%。我們也繼續預計在 2024 年剩餘季度啟動 52 至 56 個新的美國中心,並建立 12 至 14 個新的美國銷售地區。鑑於我們業務的強勁勢頭和不斷提高的營運槓桿,我們現在預計 2024 年全年的攤薄淨利潤將在每股 1.20 美元至 1.40 美元之間。

  • In conclusion, our strong performance and business momentum provide us with confidence in our outlook for the remainder of 2024.

    總之,我們強勁的業績和業務勢頭使我們對 2024 年剩餘時間的前景充滿信心。

  • With that, our prepared remarks are concluded. Dulueem, you may now open the line for questions.

    至此,我們準備好的發言結束了。Dulueem,您現在可以撥打電話提問。

  • Operator

    Operator

  • (Operator Instructions) Robbie Marcus, JPMorgan.

    (操作員指示)Robbie Marcus,摩根大通。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Great. Congrats on a nice quarter. Thank you for taking the questions. Two for me, top-line and bottom-line question. Maybe I'll start with the bottom line. Once again, fantastic upside on profitability, very nice EPS, margin upside versus consensus and the guide. Maybe just speak to the sustainability and trajectory of those margins? I see what's implied in the guide for fourth quarter. But really, just thinking further out, it seems like you've been able to leverage your DTC spending better, you were down year over year. How do you think about the trajectory forward, the need for investment in '25 behind the new launch? And I guess, really, can we see this continue upwards as sales grow?

    偉大的。恭喜您度過了一個美好的季度。感謝您提出問題。對我來說有兩個問題:首要問題和底線問題。也許我會從底線開始。再一次,獲利能力有巨大的上升空間,每股收益非常好,利潤率相對於共識和指南有上升空間。也許只是談談這些利潤的可持續性和軌跡?我明白第四季指南中暗示的內容。但實際上,只要進一步思考,您似乎能夠​​更好地利用您的 DTC 支出,而您的支出卻逐年下降。您如何看待未來的發展軌跡以及新產品發布背後對 25 年投資的需求?我想,隨著銷售額的成長,我們真的能看到這種情況持續上升嗎?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Sure. Hi, Robbie. We want to continue, as we said, when we became profitable that we want to see consistency in getting leverage throughout our organization, not just with DTC, but also with our R&D as well as the performance of our sales team through increased utilization. So we want to continue moving forward, lot to in there, but we have shown some efficiencies with our DTC as you highlight there to be able to continue to create awareness and bring patients into the system yet be able to do that in a more efficient and cost appropriate manner. But yes, we continue to move forward in a profitable state.

    當然。嗨,羅比。正如我們所說,我們希望繼續獲利,當我們實現盈利時,我們希望看到整個組織的影響力保持一致,不僅是 DTC,還包括我們的研發以及透過提高利用率來提高銷售團隊的績效。因此,我們希望繼續向前推進,但我們已經透過 DTC 展示了一些效率,正如您所強調的那樣,能夠繼續提高意識並將患者帶入系統,同時能夠以更有效率的方式做到這一點和成本適當的方式。但是,是的,我們繼續在盈利的狀態下前進。

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Hey, Robbie. This is Rick. I'll add on to that. One item to call out is the R&D expense. It did -- it was reduced to about 13% of our Q3 revenue, historically that's been closer to the higher teens. And so, one of the phenomenon there is that we did have some prelaunch inventory, $1.7 million that was expensed in the third quarter of 2023. We did not have that in this quarter. And so we do expect R&D to be in the mid- to high-teens on a go-forward basis. We also had some development costs shift from development really into more of the regulatory process. We did not have some of those R&D costs in the third quarter. But we still expect that we'll have continued profitability on a year-over-year basis.

    嘿,羅比。這是瑞克。我會補充這一點。需要指出的一項是研發費用。確實如此——它減少到了我們第三季收入的 13% 左右,從歷史上看,這個數字更接近十幾歲的水平。因此,其中一個現像是,我們確實有一些發布前的庫存,即 170 萬美元,已在 2023 年第三季支出。我們本季沒有這樣的情況。因此,我們確實預期研發將在未來的基礎上保持在中高水準。我們還有一些開發成本從真正的開發轉移到更多的監管過程。第三季我們沒有一些研發成本。但我們仍然預期我們將保持年比持續獲利。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Great. Appreciate that. And maybe just for my follow-up on the top line. Tim, I think it was on the last quarter call -- maybe it was at an investor conference earlier this quarter, you talked about improving sequential utilization third quarter over second quarter, fourth quarter over third quarter. Now that we have the results, what are you seeing in terms of utilization? How do you feel about third quarter and what do you think -- or what's implied in the guide in fourth quarter? Thanks a lot.

    偉大的。很欣賞這一點。也許只是為了我對頂線的後續行動。提姆,我想是在上個季度的電話會議上——也許是在本季早些時候的投資者會議上,您談到了第三季度比第二季度、第四季度比第三季度連續利用率的提高。現在我們已經有了結果,您對利用率有何看法?您對第三季有何看法?多謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Yeah. I think we had a great Q3. I do -- the utilization from Q2 to Q3 is consistent between the two. We do have a step up from the prior-year period. It is our aspiration to be able to continue to grow utilization, and that will remain our focus going forward. I think maybe we saw a little seasonality in Q3 and maybe a late impact regionally at the end of the quarter. But I think, overall, we're happy with the performance in Q3 and utilization is flat to Q2.

    是的。我認為我們的第三季表現很棒。我確實認為,從第二季到第三季的利用率在兩者之間是一致的。我們確實比去年同期有所進步。我們希望能夠繼續提高利用率,這將仍然是我們未來的重點。我認為也許我們在第三季度看到了一些季節性因素,並且可能在季度末看到了區域性的後期影響。但我認為,總體而言,我們對第三季的表現感到滿意,利用率與第二季持平。

  • Robbie Marcus - Analyst

    Robbie Marcus - Analyst

  • Appreciate it. Thanks a lot.

    欣賞它。多謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Robbie.

    謝謝,羅比。

  • Operator

    Operator

  • Danielle Antalffy, UBS.

    丹妮爾·安塔菲,瑞銀集團。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Hi, good afternoon, guys. Thanks so much for taking the question. Congrats on a strong quarter here. Just to follow up on Robbie's question around the guidance and specifically, the comment, I think, Tim, that you made around reflecting some potential impacts from the IV fluid shortage and the hurricanes, any way to quantify that? Or maybe the way to ask the question is, how would we be thinking about utilization? Were we not seeing some impact there?

    嗨,大家下午好。非常感謝您提出問題。恭喜本季表現強勁。只是為了跟進羅比圍繞指南提出的問題,具體來說,蒂姆,我認為您圍繞靜脈輸液短缺和颶風的一些潛在影響所做的評論,有什麼方法可以量化嗎?或者也許問這個問題的方式是,我們將如何考慮利用率?我們沒有看到一些影響嗎?

  • And then just a follow-up after that.

    然後就是後續行動。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Sure. We think it's difficult to quantify at this time. We anticipate the combination of the hurricanes as well as the saline shortages will represent some revenue headwind in the fourth quarter, mostly due to the evacuation and center closures. The IV solution is more of a national phenomenon and is required in all of our procedures, including the DISE. But we're tracking that closely, and we have staff affected in the area due to the hurricanes. So we're making sure that we take care of them and we know that the centers, the hospital in the regions are working really hard to overcome the challenges of the hurricane.

    當然。我們認為目前很難量化。我們預計颶風和鹽水短缺的結合將為第四季度的收入帶來一些阻力,這主要是由於疏散和中心關閉造成的。IV 解決方案更多是一種全國現象,並且是我們所有程序(包括 DISE)中所必需的。但我們正在密切跟踪,該地區的工作人員因颶風而受到影響。因此,我們確保照顧好他們,我們知道各地區的中心和醫院正在非常努力地克服颶風的挑戰。

  • And while it's regionally focused, we certainly are working hard to make sure we can do whatever we can to help in those areas. But we do expect some impact at least regionally, but we're working as hard as you can to overcome that. But again, it's very difficult to quantify at this time.

    雖然它以區域為重點,但我們當然正在努力確保我們能夠盡我們所能為這些地區提供幫助。但我們確實預計至少會在區域範圍內產生一些影響,但我們正在盡最大努力克服這一影響。但同樣,目前很難量化。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Got it, okay. That's helpful. And then the follow-up I had is on what you guys are seeing at the sort of start of the funnel, thinking about like from the sleep physician perspective, feedback perspective, with -- we got approval for the app measuring obstructive sleep apnea, and our techs indicate like doctors expect what are already pretty long wait list to continue to grow. Anything you can say about what you're seeing there and sort of how to think about that as a potential tailwind in 2025? Thanks so much, guys.

    明白了,好吧。這很有幫助。然後我的後續行動是關於你們在漏斗開始時看到的情況,從睡眠醫生的角度、反饋的角度思考——我們測量阻塞性睡眠呼吸中止症的應用程序獲得了批准,我們的技術人員表示,醫生預計已經很長的等待名單會繼續增長。對於您所看到的情況,您有什麼想說的嗎?非常感謝,夥計們。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Danielle. That's a great question. I think the key is we have to look at all the avenues that people are becoming aware of the quality of their sleep, be it from sensors in their bed, being it to the Apple watches, be it the various technologies that are available. We also have other diagnostic techniques that can help sleep physicians diagnose more patients. And we know that GLP-1s will increase awareness of the quality of sleep as well. So we believe all of these will add to an increased awareness of sleep quality and identify many patients who do have sleep-disordered breathing and specifically, obstructive sleep apnea.

    謝謝,丹妮爾。這是一個很好的問題。我認為關鍵是我們必須專注於人們了解睡眠品質的所有途徑,無論是透過床上的感測器,還是蘋果手錶,無論是各種可用的技術。我們還有其他診斷技術可以幫助睡眠醫生診斷更多患者。我們知道 GLP-1 也會提高人們對睡眠品質的認識。因此,我們相信所有這些都將提高人們對睡眠品質的認識,並識別出許多確實患有睡眠呼吸障礙,特別是阻塞性睡眠呼吸中止症的患者。

  • So we do think it's going to be a tailwind going forward, and it's our job to continue our DTC and our awareness programs and to improve our ability to connect these patients with the healthcare providers. And as you mentioned, their demand is going to be continuing to grow. So we need to find efficiencies and helping our patients through the overall process.

    因此,我們確實認為這將成為未來的順風車,我們的工作是繼續我們的 DTC 和我們的意識計劃,並提高我們將這些患者與醫療保健提供者聯繫起來的能力。正如您所提到的,他們的需求將繼續增長。因此,我們需要提高效率並幫助我們的患者完成整個過程。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Thank you.

    謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Danielle.

    謝謝,丹妮爾。

  • Operator

    Operator

  • Travis Steed, Bank of America Securities.

    特拉維斯·斯蒂德,美國銀行證券公司。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Hey, congrats on the good quarter. I wanted to ask about the coding strategies for Inspire V. If you could kind of elaborate on what some of the potential outcomes could be around that and the decision to not take a price increase on Inspire V?

    嘿,恭喜這個季度的好成績。我想問Inspire V的編碼策略。您能否詳細說明圍繞此問題可能產生的一些潛在結果以及不提高 Inspire V 價格的決定?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Well, we have really one option that we're working with the payers, and we want to make sure that the Medicare, the MACs, as well as the payers are fully aware of this, and we can communicate with them. And then we're also -- we'll be working with our physicians. But we think the OPPS rules are consistent, and they show just a slight increase.

    嗯,我們確實有一個選擇,那就是與付款人合作,我們希望確保 Medicare、MAC 以及付款人充分意識到這一點,並且我們可以與他們溝通。然後我們還將與我們的醫生合作。但我們認為 OPPS 規則是一致的,只是略有增加。

  • And with that, we thought it was appropriate to maintain a system-level pricing when we introduce V versus Inspire IV. And remember, we don't have the pressure sensing lead anymore with the Inspire V system. So we will be adjusting the price of the neurostimulator, but the system-level pricing will be consistent. And we'll lay all this coding out once we get the direct feedback from the which we are already making good progress on and believe we'll be ready to go when we launch.

    因此,我們認為在推出 V 與 Inspire IV 時保持系統級定價是合適的。請記住,Inspire V 系統不再配備壓力感測導線。因此,我們將調整神經刺激器的價格,但係統級定價將保持一致。一旦我們得到直接回饋,我們就會安排所有這些編碼,我們已經在這方面取得了良好的進展,並相信我們將在發佈時做好準備。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Great. And I have a follow-up on 2025. I think before you said you were fine with the consensus at 2025. Is that still the case? And just how you're thinking about some of the puts and takes around competition baking in Inspire V, GLP-1s? Any other puts and takes to think about on 2025 at this point?

    偉大的。我還有 2025 年的後續。我想在你之前說過你對 2025 年的共識很滿意。現在還是這樣嗎?您如何看待 Inspire V、GLP-1 中的競賽烘焙中的一些操作?目前對於 2025 年還有其他需要考慮的嗎?

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Yeah, sure. Hey, Travis. It's Rick. Still a little early to comment on 2025 because we're right in the middle of our planning. But as we mentioned before, we continue to think that the current consensus, if you will, for 2025 is not unreasonable. We will provide some more color soon as we get to our Q4 earnings call. But some of the moving parts that really give us confidence for 2025 include our ongoing footprint expansion of more centers and more sales territories. Our targeted DTC investments.

    是的,當然。嘿,崔維斯。是瑞克。現在對 2025 年發表評論還為時過早,因為我們正處於計劃之中。但正如我們之前提到的,我們仍然認為目前對於 2025 年的共識並非不合理。我們將在第四季財報電話會議上盡快提供更多資訊。但真正讓我們對 2025 年充滿信心的一些變化包括我們不斷擴大業務範圍,擴大更多中心和更多銷售區域。我們的目標 DTC 投資。

  • We've not talked about France much, but we expect some contribution outside the US from France. And also, the -- obviously, the launch of Inspire V, and we continue to finally -- we get updated indication with our payers on the expanded indications for BMI and AHI in more payer coverages. Those are some tailwinds, I guess, for 2025.

    我們沒有過多談論法國,但我們期望法國在美國以外做出一些貢獻。而且,顯然,Inspire V 的推出,我們最終繼續向我們的付款人提供有關更多付款人保險範圍內 BMI 和 AHI 擴展適應症的最新指示。我想,這些都是 2025 年的一些有利因素。

  • Travis Steed - Analyst

    Travis Steed - Analyst

  • Great, thanks a lot.

    太好了,非常感謝。

  • Operator

    Operator

  • Adam Maeder, Piper Sandler.

    亞當梅德,派珀桑德勒。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Congrats on the quarter and the impressive leverage. And thanks for taking the questions. Maybe just picking up on that thread on 2025. Rick, you just kind of outlined the tailwinds for next year. But as you think about maybe some of the potential headwinds that could face the business in '25, whether it's potential impact from device competition or GLP-1s and tirzepatide, would just love for you to kind of provide some early thoughts there in terms of how you see that potentially impacting the business? I have a follow-up. Thanks.

    恭喜本季的業績和令人印象深刻的槓桿率。感謝您提出問題。也許 2025 年才開始關注這個主題。瑞克,你剛剛概述了明年的順風車。但當你想到 25 年業務可能面臨的一些潛在阻力時,無論是設備競爭還是 GLP-1 和替澤帕肽的潛在影響,我希望你能夠提供一些關於以下方面的早期想法:您如何看待這對業務的潛在影響?我有一個後續行動。謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Sure. I think that as far as well-established in our market with our centers and physicians, and we need to continue to watch to see if there's going to be any new products released in 2025 I'm sure there will be some experimenting with that technology but with our growth and utilization and the tailwinds that Rick described a minute ago we're not too worried about that. We'll continue to grow the adoption of Inspire therapy.

    當然。我認為,就我們的中心和醫生在我們市場上的地位而言,我們需要繼續觀察 2025 年是否會發布任何新產品,我確信將會對該技術進行一些試驗但隨著我們的增長和利用以及里克一分鐘前描述的順風,我們並不太擔心這一點。我們將繼續擴大 Inspire 療法的採用。

  • As far as GLP-1s, again, we'll wait and track the progress with those pharmaceuticals. And when they will be available with an indication for obstructive sleep apnea, we're waiting for the FDA to weigh in on that. But again, as we talked about, those products treat a different mechanism of action. And we think that GLP-1s will be complementary to Inspire therapy.

    至於 GLP-1,我們將再次等待並追蹤這些藥物的進展。當它們出現用於阻塞性睡眠呼吸中止症的適應症時,我們正在等待 FDA 對此進行權衡。但正如我們所討論的,這些產品的作用機制不同。我們認為 GLP-1 將與 Inspire 療法形成補充。

  • What we do believe is it's going to help people lose weight. It's going to help them relax their lateral walls, which is going to be able to present them with tongue base collapse and suitable for Inspire therapy. So again, I think a release of a GLP-1 will be a tailwind for us, but we do look forward to a positive 2025 coming forward.

    我們確實相信它會幫助人們減肥。它將幫助他們放鬆側壁,這將能夠使他們出現舌根塌陷並適合 Inspire 療法。因此,我再次認為 GLP-1 的發布將對我們來說是順風車,但我們確實期待 2025 年的積極發展。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • That's helpful, thank you for that. And for the follow-up, maybe if we could just double-click on the Gen 5 rollout and hoping for some additional granularity there. It sounds like progressing to a soft launch. What exactly does that look like? How are you coming along on the manufacturing and inventory side? Should we expect kind of an early 2025 full launch?

    這很有幫助,謝謝你。對於後續行動,也許我們可以雙擊第 5 代的推出,並希望那裡有一些額外的粒度。聽起來像是正在邁向軟啟動。那到底是什麼樣子的呢?你們在製造和庫存方面進展如何?我們是否應該期待 2025 年初全面推出?

  • And then just on the margin side, pricing sounds like is at parity to Gen 4, but will this still be gross margin accretive? Thanks again.

    然後就利潤率而言,定價聽起來與第四代持平,但這仍然會增加毛利率嗎?再次感謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Adam. I think the key is exactly that. It's having the manufacturing lines up and running. And with the success that we've had over the years, we need to make sure that we have the proper amount of inventory on the shelf prior to launch and the production line is active, and we're making sure that we're preparing for that. And when we have the proper inventory, we will go ahead and launch.

    謝謝你,亞當。我認為關鍵正是如此。它正在啟動並運行生產線。憑藉我們多年來的成功,我們需要確保在推出之前貨架上有適當數量的庫存,並且生產線處於活躍狀態,並且我們正在確保我們正在做好準備為此。當我們擁有適當的庫存時,我們將繼續推出。

  • Several elements that also happen as part of the readiness is we will need new contracts with all centers because it is a new model release. We will be training our internal team as well as training all physicians on the use of the new Inspire V device. So all positives, and we are preparing across the board for it. And as you mentioned, while the price is remaining consistent with the Inspire IV in that we do not require to produce the sensing lead anymore, it will reduce our COGs, and we believe that we'll see a slight increase in gross margin over time.

    作為準備工作的一部分,我們還需要與所有中心簽訂新合同,因為這是一個新模型的發布。我們將培訓我們的內部團隊以及所有醫生如何使用新的 Inspire V 設備。所有這些都是積極的,我們正在為此做好全面準備。正如您所提到的,雖然價格與 Inspire IV 保持一致,因為我們不再需要生產感測引線,但這會減少我們的 COG,我們相信隨著時間的推移,我們會看到毛利率略有增加。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Thank you.

    謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • David Rescott, Baird.

    大衛雷斯科特,貝爾德。

  • David Rescott - Analyst

    David Rescott - Analyst

  • Great. Thanks for taking the questions, and congrats on the quarter here. First one from us, the margin in the quarter is obviously pretty outstanding. I did want to ask more so on the DTC, the advertising side. It looks like that's been pretty flat, if not down slightly year over year. When you think about the level of investment that you have in DTC so far this year, I mean, is that something that you think can probably remain pretty flat into the out years? Does it continue to maybe go down on a year-over-year basis? Or is there some point in the future where maybe you have to start to reaccelerate that just to support the level of growth that's out there?

    偉大的。感謝您提出問題,並祝賀本季取得成功。我們的第一個數據是,本季的利潤率顯然相當出色。我確實想在 DTC(廣告方面)問更多問題。看起來這一數字即使不是同比略有下降,也相當持平。當您考慮今年迄今為止在 DTC 的投資水平時,我的意思是,您認為這在未來幾年可能會保持相當穩定嗎?它是否會繼續同比下降?或者在未來的某個時刻,你可能必須開始重新加速,以支持現有的成長水準?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Yeah, David, we're going to continue to invest in our growth. There's no question about that. And that comes in many forms, certainly with R&D because we're already talking about Inspire V and certainly with the continued scaling of our field organization, but also making sure that we measure the effectiveness of our DTC.

    是的,大衛,我們將繼續投資我們的成長。毫無疑問。這有多種形式,當然是研發,因為我們已經在談論 Inspire V,當然還有我們現場組織的持續擴展,但也要確保我們衡量 DTC 的有效性。

  • And while we mentioned over the time that we are able to build efficiencies and still get strong response in building the awareness of Inspire, we'll continue to monitor our DTC spend. And while it's been pretty consistent of late with gaining efficiencies and bringing the attention and still bringing the patients, requesting appointments with healthcare providers, we'll continue to monitor that and we're not committing long term that will continue to decrease and we may increase it to even grow adoption further. So again, really focused on investing in growth. Any other comment on that?

    雖然我們一直以來都提到,我們能夠提高效率,並且在建立 Inspire 的認知度方面仍能獲得強烈反響,但我們將繼續監控我們的 DTC 支出。雖然最近與提高效率、引起關注、仍然吸引患者、請求與醫療保健提供者預約保持一致,但我們將繼續監控這一點,並且我們不會長期承諾將繼續減少,我們可能會增加它甚至進一步提高採用率。再次強調,真正專注於成長投資。對此還有其他評論嗎?

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Yeah. I've mentioned from the dollar perspective, we mentioned in 2024 that the overall spend for the year will be relatively flat over 2023 where we spent $100 million in DTC, but we are also making medical education investments and those are higher in 2024. We're increasing our investments in training programs for the sleep fellows and ENTs. And so that, along with being more targeted and efficient in our digital advertising focus, it's allowed us to decrease the spend, but still have kind of wider DTC initiatives.

    是的。我從美元的角度提到過,我們在2024 年提到,今年的總體支出將與2023 年相對持平,當時我們在DTC 上花費了1 億美元,但我們也在進行醫學教育投資,並且2024 年的投資會更高。我們正在增加對睡眠研究員和耳鼻喉科醫師培訓計畫的投資。因此,除了我們的數位廣告重點更有針對性和高效之外,它還使我們能夠減少支出,但仍有更廣泛的 DTC 計劃。

  • David Rescott - Analyst

    David Rescott - Analyst

  • Thanks. Maybe on international, you called out France for next year. I know in Q4, you had a -- you have a little bit of a benefit, I guess, on a year-over-year basis in the fourth quarter for this year. So maybe can you help us think about how you're thinking about the implications for international in the fourth quarter this year? And then any other color, I think, that you could provide just around some of these additional markets that are contributing maybe the size of what France could be, but just help us think about that broader growth into 2025 as well? Thank you.

    謝謝。也許在國際比賽中,你提到了明年的法國隊。我知道在第四季度,我想,今年第四季與去年同期相比,你有一點好處。那麼,也許您可以幫助我們思考您如何看待今年第四季對國際市場的影響?然後,我認為,您可以在這些額外市場中提供任何其他顏色,這些市場的貢獻可能與法國的規模相當,但也能幫助我們思考到 2025 年更廣泛的成長?謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Sure. I think the two big markets that are going to have a positive impact going forward are going to be France and the UK. And I think that both of them are just up and comers right now. Obviously, we just spoke last quarter about the country-wide reimbursement in France and our ability now to really start to open up the centers and start to take advantage of that and help patients in France receive therapy. So we're going to help them build their business over the next several years.

    當然。我認為未來將產生正面影響的兩個大市場將是法國和英國。我認為他們倆現在都剛起步。顯然,我們上個季度剛剛談到了法國的全國範圍內的報銷,以及我們現在真正開始開放中心並開始利用這一點並幫助法國患者接受治療的能力。因此,我們將幫助他們在未來幾年內發展業務。

  • And I think we're also seeing increased performance out of the United Kingdom. And that being said, we still have another year to go in the DACH region with Germany, Austria, Switzerland. And again, Belgium and Netherlands continue to perform quite well. And we will make some progress over in the Asian markets as well. So I think we'll see a consistent growth in international markets, as we've seen in the past.

    我認為我們也看到英國的表現有所提升。話雖如此,我們與德國、奧地利、瑞士的 DACH 地區還有一年的時間。比利時和荷蘭再次表現出色。我們也將在亞洲市場取得一些進展。因此,我認為我們將看到國際市場的持續成長,正如我們過去所看到的那樣。

  • David Rescott - Analyst

    David Rescott - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Michael Sarcone, Jefferies.

    邁克爾·薩爾科內,杰弗里斯。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Great. Thank you for taking the question. Just a follow-up actually on Adam's question about the Inspire V rollout. Tim, you mentioned a few things that have to be done, including renegotiating some of those contracts. Do you think you can just talk about whether or not that's a heavy lift or does that vary by the type of account or customer?

    偉大的。感謝您提出問題。實際上只是 Adam 關於 Inspire V 推出的問題的後續行動。提姆,你提到了一些必須要做的事情,包括重新談判其中一些合約。您認為您可以只討論這是否是一項繁重的工作,或者這是否因帳戶或客戶的類型而異?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • I think with our decision to leave system level pricing consistent with the existing pricing of the contract, it minimizes that burden. It really is a logistics process to go through with centers just to make sure that we have the new product added on to the pricing this in the addendum. So we don't believe it's going to be too much of a heavy lift to complete those contracts.

    我認為,透過我們決定讓系統級定價與合約的現有定價保持一致,可以最大限度地減少這種負擔。這實際上是一個與中心進行的物流過程,只是為了確保我們將新產品添加到附錄中的定價中。因此,我們認為完成這些合約不會有太大的困難。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Great, thank you. And then just we saw the PREDICTOR data a few weeks ago. I was just curious if you had any update on how your conversations with payers are resonating now that we have that data?

    太好了,謝謝。然後我們幾週前就看到了 PREDICTOR 數據。我只是好奇,既然我們掌握了這些數據,您與付款人的對話是否會產生共鳴,您是否有任何最新消息?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Payers are receptive. They want to understand better ways to help patients through the process. And if they don't require to have a drug-induced sleep endoscopy, that can save the payer a little bit of investment in that patient's diagnostic without reducing the quality of care, and that's what's most important.

    付款人很樂意接受。他們希望了解更好的方法來幫助患者完成整個過程。如果他們不需要進行藥物誘導的睡眠內視鏡檢查,那麼可以為付款人節省一點在患者診斷上的投資,而不會降低護理質量,這是最重要的。

  • And as you saw at the meeting, there is an introduction of an algorithm for patients who have a BMI less than 32. And for patients with less than 28 -- BMI less than 28, they really don't have a lot of lateral wall collapse. So the proposal or the algorithm is that they can proceed directly to implant.

    正如您在會議上看到的,針對 BMI 小於 32 的患者引入了演算法。對於BMI低於28的患者來說,他們確實沒有太多的側壁塌陷。所以建議或者演算法是他們可以直接進行植入。

  • And those between the BMI 28 and 32, they want to have one more method, and that was the idea presented if neck circumference is less than 18 inches patient could proceed to therapy. So we need to collect a little bit more information on that. But it's a pretty strong algorithm that we can look at and have discussions with payers as well as physicians to be able to adopt that process.

    而那些BMI在28到32之間的人,他們希望有另一種方法,這就是如果頸圍小於18英吋的患者可以繼續治療的想法。因此,我們需要收集更多相關資訊。但這是一個非常強大的演算法,我們可以研究它並與付款人和醫生進行討論,以便能夠採用該流程。

  • So it's very good to be able to present that data. The physicians are working on a peer-reviewed publication, and there are two other abstracts at the meeting talking about lateral wall collapse as well. So we're going to combine a lot more of this information to get everything put together as we take the next step forward with this.

    所以能夠呈現這些數據是非常好的。醫生們正在撰寫一份同行評審的出版物,會議上還有另外兩篇摘要也討論了外側壁塌陷。因此,當我們採取下一步行動時,我們將結合更多這些訊息,將所有內容放在一起。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Okay. Thanks, Tim.

    好的。謝謝,蒂姆。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Richard Newitter, Truist Securities.

    理查德紐特 (Richard Newitter),Truist 證券公司。

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • Hey, guys. Thanks for taking the questions. Congrats on a good quarter here, especially the profit. I wanted to start. First question, just on the Inspire V coding strategy. If you could get a little more specific. Our understanding was that the most logical route or strategy is to go back to using the cranial neurostimulation code. Is that correct?

    嘿,夥計們。感謝您提出問題。恭喜本季表現良好,尤其是利潤。我想開始。第一個問題,關於 Inspire V 編碼策略。如果你能說得更具體一點的話。我們的理解是,最合乎邏輯的路線或策略是回到使用顱神經刺激程式碼。這是正確的嗎?

  • And then if it were, can you just talk to what your confidence level is that whether it's that pathway or some other pathway that you can keep the physician economics neutral to where they stand now, given the faster procedure time on a per kind of unit to time basis?

    然後,如果是的話,您能否談談您的置信度是多少,無論是該途徑還是其他途徑,您都可以使醫生的經濟狀況保持在目前的水平上,考慮到每種設備的手術時間更快以時間為基礎?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Yeah. And Rich, we're making sure that we have this work through with the MACs and the payers first before we really kind of lay themselves. We want to make sure that they have a fair shake at all the information and be able to come back and weigh in. The advantage that we have going forward, as you highlight, the Inspire V procedure shorter in that we do not need to implant the pressure sensing lead anymore, but that also improves the ability to do interoperative testing. That saves a little bit of time as well. So yes, when we get down to it, it's going to be a measure of physician reimbursement on a per minute basis.

    是的。Rich,我們要確保在我們真正開始行動之前,先與 MAC 和付款人完成這項工作。我們希望確保他們對所有資訊有公平的了解,並能夠回來權衡。正如您所強調的,我們未來的優勢是 Inspire V 程式更短,因為我們不再需要植入壓力感測引線,但這也提高了進行互通測試的能力。這也節省了一點時間。所以,是的,當我們認真考慮時,這將是每分鐘計算的醫生報銷衡量標準。

  • But what we look at, Rich, is if we can reduce the OR time, such that physicians can do more procedures in a single surgical day. That's a significant benefit because they can bring in significantly more revenue whatever code they use to be able to take care of more patients. So however you look at it, it's still going to be a net positive for the physicians in that it builds efficiencies and allows them to take care of more patients. And as we've talked about, we know the limiting factor that we have today is we simply do not have enough capacity with ENTs to take care of all the patients that we have. So being able to reduce OR time allows for more procedures in a day and the relative value of these codes is such that it's still going to be a net benefit for the physicians either way.

    但 Rich,我們關注的是是否可以減少手術室時間,以便醫生可以在單一手術日內完成更多手術。這是一個顯著的好處,因為無論他們使用什麼代碼來照顧更多的患者,他們都可以帶來更多的收入。因此,無論你如何看待它,它對醫生來說仍然是一個淨積極的結果,因為它提高了效率並允許他們照顧更多的病人。正如我們所討論的,我們知道我們今天面臨的限制因素是我們根本沒有足夠的耳鼻喉科能力來照顧我們擁有的所有患者。因此,能夠減少手術室時間可以在一天內進行更多手術,而這些代碼的相對價值使得無論哪種方式它仍然會給醫生帶來淨收益。

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • Okay, thanks for that. And then just going back to the 2025, you don't view consensus as unreasonable or consensus looks reasonable, however, you want to phrase that. I guess, because there's an international component to consensus, I'm just trying to think on US utilization. You've talked in the past about the goal being to consistently grow utilization in the US year over year. I guess, when you say consensus doesn't look unreasonable, the consensus does project modest, but still growth in US utilization year over year, low single digits. I guess, does that count as part of your comment that the consensus looks reasonable? Thank you.

    好的,謝謝。然後回到 2025 年,你不會認為共識是不合理的,也不會認為共識看起來合理,但你想表達這一點。我想,因為共識有國際組成部分,所以我只是想考慮美國的利用情況。您過去曾談到目標是逐年持續提高美國的使用率。我想,當你說共識看起來並非不合理時,共識確實預測了美國利用率的適度增長,但仍同比增長,較低的個位數。我想,這是否算是您認為共識看起來合理的評論的一部分?謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Rich. Yeah, we do want to continue to grow utilization. We do know same-store sales is an important aspect to the growth of Inspire. And we also know that centers that have the highest utilization also have the highest patient outcomes. Well, that's natural because there is more experience in every healthcare provider associated with that center has more experience.

    謝謝你,里奇。是的,我們確實希望繼續提高利用率。我們確實知道同店銷售是 Inspire 成長的一個重要面向。我們也知道,利用率最高的中心也具有最高的患者治療效果。嗯,這是很自然的,因為與該中心相關的每個醫療保健提供者都有更多的經驗。

  • So as we look for utilization into the future, we want to continually grow same-store sales, and that will continue to be a focus going forward. And that is incorporated when we make our comments that the consensus next year is not unreasonable. And we do take into account the international business as well.

    因此,當我們尋求未來的利用率時,我們希望不斷成長同店銷售額,這將繼續成為未來的重點。當我們評論明年的共識並非不合理時,這一點就被納入其中。我們也確實考慮了國際業務。

  • Richard Newitter - Analyst

    Richard Newitter - Analyst

  • Okay, thanks, Tim.

    好的,謝謝,提姆。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Larry Biegelsen, Wells Fargo.

    拉里·比格爾森,富國銀行。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Hi, good afternoon. Thanks for taking the questions. Tim, I'll make this pretty quick, two quick ones. One is when you do the soft launch, what are you going to tell surgeons -- how are you going to tell surgeons to bill for Inspire V, if you're not going to disclose the coding until next year? And second, is there any concern at this point of patient warehousing for Inspire V ahead of the full launch? Thanks.

    嗨,下午好。感謝您提出問題。提姆,我會做得很快,兩個很快。一是當你進行軟啟動時,你要告訴外科醫生什麼——如果你要到明年才披露編碼,你將如何告訴外科醫生為 Inspire V 付費?其次,在全面推出之前,Inspire V 的病患倉儲是否有任何問題?謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Larry. The physicians will have specific instructions with their payers for their soft launch of the Inspire V procedure. So they will be brought under the tent to make sure that they're able to work with the payers to get the proper sequencing all set up.

    謝謝,拉里。醫生將向付款人發出具體指示,以軟啟動 Inspire V 程序。因此,他們將被帶到帳篷下,以確保他們能夠與付款人合作,以建立正確的排序。

  • Number two, we believe people will become aware of Inspire V. We don't believe there will be a significant delay in patients wanting therapy. Especially in 2024, we know that with the high deductible insurance plans, patients are really going to be pushing hard to get the therapy in the year, but we'll continue to monitor that as we get into '25 and prepare for the full launch.

    第二,我們相信人們會意識到 Inspire V。我們認為需要治療的患者不會有明顯的延誤。特別是在 2024 年,我們知道,憑藉高免賠額保險計劃,患者確實會努力爭取在這一年接受治療,但我們將在進入 25 年後繼續監控這一情況,並為全面啟動做好準備。

  • Larry Biegelsen - Analyst

    Larry Biegelsen - Analyst

  • Got it. Thanks for the question.

    知道了。謝謝你的提問。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Larry.

    謝謝,拉里。

  • Operator

    Operator

  • Shagun Singh, RBC.

    沙貢辛格,加拿大皇家銀行。

  • Shagun Singh - Analyst

    Shagun Singh - Analyst

  • Great. Thank you so much. I guess just two clarification topics on Q4 and '25. If you look at sequential growth from Q3 to Q4, it implies about teams. And looking at the past 5 years, you've pretty consistently delivered sequential growth in the high-20s. It comes to somewhere around $20 million in that differential. And I'm just wondering what have you contemplated in your guidance for this hurricane IV saline shortage? And then is there any US inventory dynamic at play ahead of the Inspire V launch or is it conservatism? Anything you can share there?

    偉大的。太感謝了。我想只有關於第四季和 25 年的兩個澄清主題。如果你看一下從第三季到第四季的連續成長,這意味著團隊的成長。回顧過去 5 年,您的連續成長速度一直在 20 多歲左右。這個差價約為 2000 萬美元。我只是想知道您在應對颶風 IV 鹽水短缺的指導中考慮了什麼?那麼,在 Inspire V 發布之前,美國的庫存動態是否在發揮作用,還是保守主義?有什麼可以分享的嗎?

  • And then on 2025, again, just a follow-up, why do you think consensus is reasonable at about 20% year-over-year growth versus 27% to 28% that you're looking to do this year? And there are a lot of drivers next year as we think about Inspire V, PREDICTOR, replacement cycle, et cetera? So why is that reasonable at all? And why can't you do better? Thanks for taking the questions.

    然後,關於 2025 年,再次,只是一個後續行動,為什麼您認為共識是合理的,同比增長約為 20%,而您今年的目標是 27% 至 28%?當我們考慮 Inspire V、PREDICTOR、更換週期等等時,明年會有很多驅動程式?那麼為什麼這是合理的呢?為什麼你不能做得更好?感謝您提出問題。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Very good. Let's start with Q4 and start with the hurricane. Again, we are still kind of assessing the regional impact of the hurricanes. Again, we have our own team members who are displaced and working to make sure that they're all taken care of and the centers are back up and running. and potential patients they're able to get back to their homes and get back in and try and recover including scheduling a lot of the cases.

    非常好。我們先從Q4開始,從颶風開始。同樣,我們仍在評估颶風的區域影響。同樣,我們有自己的流離失所的團隊成員,並努力確保他們都得到照顧,並且中心恢復正常運作。和潛在的患者,他們能夠回到家中並嘗試康復,包括安排許多病例。

  • But also remember in the fourth quarter, that's when we run up against our capacity because as you mentioned, with the step-up from Q3, we run at a higher utilization and there is a high demand in there. So it's -- we don't have a lot of capacity to make up. So that's why we're closely monitoring the regional performance there. But we're doing everything we can to certainly help those patients as we go forward.

    但也要記住,在第四季度,我們的產能就達到了極限,因為正如您所提到的,隨著第三季度的提高,我們的利用率更高,而且那裡的需求很高。所以我們沒有太多的能力來彌補。這就是我們密切關注該地區表現的原因。但我們正在盡一切努力,在前進的過程中為這些患者提供幫助。

  • When we look at '25, yes, we have a lot of tailwinds helping us along. But again, we think that is very early, and we're still just starting our annual operating plan process. And -- but when we kind of look at our progress to date, that's where we kind of looked at those consensus numbers and we determine those are not unreasonable, but we really look forward to finishing our annual planning and coming forward with a strong plan for 2025.

    當我們回顧 25 年時,是的,我們有很多順風車幫助我們前進。但我們再次認為這還為時過早,我們仍然剛開始我們的年度營運計劃流程。但是,當我們審視迄今為止的進展時,我們就審視了這些共識數字,我們確定這些數字並非不合理,但我們真的期待著完成我們的年度計劃並提出一個強有力的計劃2025 年。

  • Shagun Singh - Analyst

    Shagun Singh - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Kallum Titchmarsh, Morgan Stanley.

    卡勒姆·蒂奇馬什,摩根士丹利。

  • Kallum Titchmarsh - Analyst

    Kallum Titchmarsh - Analyst

  • Yeah. Thanks for taking my questions, guys. I'll ask two upfront. Firstly, just wanted to understand your priorities with a strong cash pile. Last quarter, you obviously announced the buyback, but any other intentions you want to flag there as we head into 2025 and beyond?

    是的。謝謝你們回答我的問題,夥伴們。我先問兩個。首先,只是想了解您擁有大量現金的優先事項。上個季度,您顯然宣布了回購,但在我們進入 2025 年及以後,您還有其他意圖嗎?

  • And then secondly, just looking for any update on the metrics, you're thinking of providing us to help assess performance from '25 and beyond in absence of those center numbers? Thanks a lot.

    其次,只是尋找指標的任何更新,您是否正在考慮讓我們在沒有這些中心數據的情況下幫助評估 25 年及以後的績效?多謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Absolutely. We're very proud of the strong cash balance that we have. The team is working very hard. And as we mentioned, we're getting leverage across the organization to be profitable and start to move forward. With that, we did reserve for a stock buyback, and we said that we were going to be opportunistic with that. At this point, we have not triggered that buyback, as you know, as we've been tracking that very closely, but we remain opportunistic and the plan is still in place.

    絕對地。我們對擁有的強勁現金餘額感到非常自豪。團隊正在努力工作。正如我們所提到的,我們正在利用整個組織的影響力來實現盈利並開始向前發展。至此,我們確實為股票回購做好了準備,我們表示我們將對此採取機會主義態度。如您所知,目前我們尚未觸發回購,因為我們一直在密切跟踪,但我們仍然保持機會主義,並且該計劃仍然有效。

  • As far as the other use of cash, I think we always look for opportunities where we can grow the adoption of Inspire therapy. And in the past, we've made minority investments in technologies that can help us with patient flow. And we'll continue to keep our antennas up and on what technologies can really help us grow awareness and adoption of Inspire and continue to report back on that.

    至於現金的其他用途,我認為我們一直在尋找機會,以提高 Inspire 療法的採用率。過去,我們對能夠幫助我們改善患者流動的技術進行了少數投資。我們將繼續關注哪些技術可以真正幫助我們提高 Inspire 的認知度和採用率,並繼續對此進行報告。

  • As far as metrics?

    至於指標呢?

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Yeah. Regarding the 2025 metrics, we're still working through that, but we will guide to revenue and gross margin and earnings per share in 2025. We -- historically, we -- as you know, we've always been transparent, and so we want to continue that. So we will continue to disclose our US sales territories. We won't guide to that number, but we will disclose it.

    是的。關於 2025 年的指標,我們仍在研究中,但我們將指導 2025 年的收入、毛利率和每股盈餘。我們——從歷史上看,我們——如你所知,我們一直是透明的,所以我們希望繼續這樣做。因此,我們將繼續揭露我們的美國銷售地區。我們不會提供該數字,但我們會披露它。

  • And we're also discussing the fact that we will disclose possibly a number of field clinical representatives just to provide some additional insight into our business and how we continue to commercialize. But again, as we've grown and we're a larger company, we believe that profitability is more relevant guidance metric in tracking our financial performance over time.

    我們還在討論這樣一個事實:我們可能會透露一些現場臨床代表,只是為了提供對我們的業務以及我們如何繼續商業化的更多見解。但同樣,隨著我們的成長,我們成為一家規模更大的公司,我們相信,獲利能力是追蹤我們長期財務表現的更相關的指導指標。

  • Kallum Titchmarsh - Analyst

    Kallum Titchmarsh - Analyst

  • Thanks a lot.

    多謝。

  • Operator

    Operator

  • Jon Block, Stifel.

    喬恩·布洛克,斯蒂菲爾。

  • Jon Block - Analyst

    Jon Block - Analyst

  • Great. Thanks, guys. Two quick ones. Tim, I'm just curious if you're seeing any early outreach or inquiries from ENTs that are now looking to get trained due to the pending elimination of the sensing lead, simplifying the procedure, having them be a little bit more comfortable? Obviously, that could help the number of ENTs per center and free up capacity. That's the first quick one. I'll pause.

    偉大的。謝謝,夥計們。兩個快的。提姆,我只是很好奇,您是否看到耳鼻喉科的任何早期外展或詢問,這些耳鼻喉科現在由於即將取消感測引線而尋求接受培訓,簡化程序,讓他們更舒服一點?顯然,這有助於增加每個中心的耳鼻喉科數量並釋放容量。這是第一個快的。我會暫停一下。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • We talk about that, that we believe that, that will have a positive impact when physicians no longer need to place a sensing lead between the intercostal muscle as kind of the one unnatural parts of the procedure. We do believe that, that will have a positive impact. But Jon, at this point, we are not marketing Inspire V. The only time we talk about Inspire V is here on these calls to give you all some awareness of our plans going forward, but we're being very careful about talking about V outside of it.

    我們談論這一點,我們相信,當醫生不再需要在肋間肌之間放置感測引線作為手術中的一種不自然的部分時,這將產生積極的影響。我們確實相信,這將產生積極的影響。但喬恩,目前我們還沒有行銷 Inspire V。我們唯一一次談論 Inspire V 是在這些電話會議上,讓大家了解我們未來的計劃,但我們在談論 V 之外時會非常謹慎。

  • So I think that will be a phenomenon that you'll see in 2025 when it will be able to open the door. And I think -- the key to it is what you hint that is the best way for us to increase capacity is to train additional surgeons at existing sites. And I think that really helps. And that will be a focus going into next year and look forward to talking about that more in the future.

    所以我認為這將是 2025 年你會看到的一種現象,屆時它將能夠打開大門。我認為,關鍵是你所暗示的,我們增加能力的最佳方式是在現有地點培訓更多的外科醫生。我認為這確實有幫助。這將是明年的焦點,並期待將來更多地討論這個問題。

  • Jon Block - Analyst

    Jon Block - Analyst

  • That's helpful. Maybe just a follow-up there. I've actually always been surprised when we reach out the docs are very in tune with Inspire V. And quite honestly, Tim, most know about it. So I get your point if you're not marketing it, but they do seem to be pretty knowledgeable about and that it's approved, what are you telling these docs in terms of when they're going to get trained or when they can start doing the procedure, that's sort of a follow-up to that last one?

    這很有幫助。也許只是後續行動。事實上,當我們發現這些文件與 Inspire V 非常一致時,我總是感到驚訝。老實說,提姆,大多數人都知道這一點。因此,如果您不行銷它,我明白您的觀點,但他們似乎確實非常了解並且它已獲得批准,您要告訴這些文檔什麼時候他們要接受培訓或什麼時候可以開始做該程序是最後一個程序的後續程序嗎?

  • And just quickly, Rick, the EPS was huge. The OpEx that I've got it right was down about $4 million to $5 million sequentially. Back on the conference call, you expected it to be up $8 to $9 million, I think, sequentially. So just what played out throughout 3Q on the OpEx side that led it to come in considerably below what your view had been? Thanks.

    瑞克,很快,每股盈餘就非常巨大了。據我了解,營運支出連續下降了約 400 萬至 500 萬美元。回到電話會議上,我認為您預計它會連續增加 800 至 900 萬美元。那麼,整個第三季營運支出方面到底發生了什麼,導致它的表現大大低於您的預期呢?謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Quickly on the Inspire V, we do get questions when several individuals were on this call were down at the American Academy of Otolaryngology meeting and the International Sleep Surgical Society, and the Inspire V is not a large topic. We don't have it as part of our booth. Obviously, Jon, you talked to a lot of academic physicians and they have knowledge into the research ongoing, and they've been part of the evaluation. So there is a lot of talk amongst the academic physicians certainly about Inspire V.

    很快,關於 Inspire V,我們確實收到了一些問題,當時有幾個參加這次電話會議的人參加了美國耳鼻喉科學會會議和國際睡眠外科學會,而 Inspire V 並不是一個大話題。我們的展位上沒有它。顯然,喬恩,您與許多學術醫生交談過,他們了解正在進行的研究,並且他們一直是評估的一部分。因此,學術界的醫生們對 Inspire V 進行了許多討論。

  • But as far as our own discussions, we keep it relatively quiet. And so no, we haven't disclosed when they will be trained or when we will be launching it just as we discuss here.

    但就我們自己的討論而言,我們保持相對安靜。所以不,我們沒有透露他們何時接受培訓,也沒有透露我們何時啟動它,就像我們在這裡討論的那樣。

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Hey, Jon. It's Rick. Regarding the OpEx, we did have a reduction, as I mentioned, on our R&D line item because of Inspire V shifting from developmental to more operational readiness. We also -- again, DTC was down. We also -- some of our stock-based compensation just based on timing of in the past on hires and so on, that also had an impact on the sequential OpEx number. But again, we expect -- we're going to continue to invest in our business across all facets, R&D, and our sales organization.

    嘿,喬恩。是瑞克。關於營運支出,正如我所提到的,我們的研發專案確實有所減少,因為 Inspire V 從開發準備轉向了更多營運準備。我們也再次發現,DTC 下降了。我們也—我們的一些以股票為基礎的薪酬只是基於過去的招募時間等,這也對連續的營運支出數字產生了影響。但我們再次預計,我們將繼續在各個方面、研發和銷售組織方面對我們的業務進行投資。

  • Jon Block - Analyst

    Jon Block - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Anthony Petrone, Mizuho Americas.

    安東尼‧佩特龍,瑞穗美洲公司。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Hi, thanks. Maybe one on the funnel, Tim. Just when we think about GLP-1s that 32-plus BMI category potentially providing a halo effect to hypoglossal nerve stimulation, are you seeing that already in numbers? And when we think ahead to 2025, potentially having a GLP-1 on label for sleep apnea, how do you think that plays out from a funnel perspective? And then I'll have one quick follow-up for Rick. Thanks.

    你好,謝謝。也許是漏斗上的一個,提姆。當我們想到 32 以上 BMI 類別的 GLP-1 可能對舌下神經刺激產生光環效應時,您是否已經看到了這一點?當我們展望 2025 年時,GLP-1 可能會出現在治療睡眠呼吸中止症的標籤上,您認為從漏斗角度來看,效果如何?然後我將快速跟進 Rick。謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks. We watched the Maple Leafs in town last night. So sorry, we had to send them home. But -- the -- I think that's a great question. If you kind of look back with the lateral wall collapse as well as the early reimbursement policies from payers, the majority of our patients really have a BMI less than 32. So if you look at the number of patients in there, it's really going to be advantageous if we can find a better avenue to be able to move them straight to therapy or be able to assess also with neck circumference.

    謝謝。昨晚我們在城裡觀看了楓葉隊的比賽。很抱歉,我們不得不送他們回家。但是——我認為這是一個很好的問題。如果你回顧一下側壁塌陷以及付款人的早期報銷政策,我們大多數患者的 BMI 確實低於 32。因此,如果你看看那裡的患者數量,如果我們能找到更好的途徑讓他們直接接受治療或能夠透過頸圍進行評估,那真的會很有利。

  • It's really going to be a unique opportunity for those patients who really don't see a benefit of having a drug-induced sleep endoscopy because they don't really have a likelihood of having lateral wall collapse or complete concentric collapse. So really the BMI less than 32 is really just a natural breakpoint. And now, we're going to continue to keep investigating higher than 32 up to 35. But at that point, you really start to get a greater propensity for that lateral wall collapse.

    對於那些確實看不到藥物誘導睡眠內視鏡檢查好處的患者來說,這確實是一個獨特的機會,因為他們實際上不太可能發生側壁塌陷或完全同心塌陷。因此,BMI 低於 32 實際上只是一個自然的斷點。現在,我們將繼續調查 32 到 35 之間的範圍。但到了那時,你真的開始更有可能發生側壁塌陷。

  • As far as the GLP-1s, I think it's a matter of timing on when they get approval and if they get approval with the indication for obstructive sleep apnea and then what will be their time to be able to launch that product and have a positive impact. So there's still so much we don't know about that regulatory process or what their launch timing will be or how they will pursue reimbursement. But we are confident that the launch of the GLP-1s and the continued use of those drugs to be able to treat obesity is going to help patients with obstructive sleep apnea, lose weight, and come into the indication for Inspire. So we'll continue to track that, but we do believe that will be a positive tailwind well into the future.

    就 GLP-1 而言,我認為這是一個時間問題,即他們何時獲得批准,以及如果他們獲得針對阻塞性睡眠呼吸中止症適應症的批准,那麼他們什麼時候能夠推出該產品並獲得積極的反饋影響。因此,我們對監管程序、他們的啟動時間或他們將如何尋求報銷仍有許多不了解。但我們相信,GLP-1 的推出以及這些能夠治療肥胖的藥物的持續使用將幫助患有阻塞性睡眠呼吸中止症的患者減輕體重,並進入 Inspire 的適應症。因此,我們將繼續跟踪這一情況,但我們確實相信這將成為未來的積極推動力。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • That's helpful. One for Rick. Just on R&D, it stepped down quite a bit. Maybe just to recap of what studies are in there today is complete collapse still in there? And will there be additional studies launched in 2025? Thanks.

    這很有幫助。一張是給瑞克的。僅在研發方面,它就下降了不少。也許只是回顧一下今天的研究,是否仍然完全崩潰?2025 年是否還會進行更多研究?謝謝。

  • Richard Buchholz - Chief Financial Officer

    Richard Buchholz - Chief Financial Officer

  • Yeah. We're continuing to make investments in the R&D line item. There was -- we had expensed about $5 million of prelaunch inventory in 2023. And so that did not occur in 2024 because we got approval and we're getting closer to launch. So R&D was running a little hotter last year because of the prelaunch inventory, but we're still making investments as we have in the past, but we're also continuing to make investments in our SleepSync(TM), digital platform, and our digital health area. And also with the PREDICTOR study, we had clinical study expenses there. And with our recently approved SleepSync(TM) programmer, so we're continuing to make R&D investments. And that's why we're indicating that's going to be closer to mid-higher teens on a go-forward basis.

    是的。我們將繼續對研發項目進行投資。2023 年,我們花了約 500 萬美元的上市前庫存費用。因此,這種情況在 2024 年並沒有發生,因為我們獲得了批准,而且距離發布也越來越近了。由於上市前的庫存,去年的研發工作有點熱,但我們仍在像過去一樣進行投資,而且我們還將繼續對我們的 SleepSync(TM)、數位平台和我們的產品進行投資。對於 PREDICTOR 研究,我們也有臨床研究費用。憑藉我們最近批准的 SleepSync(TM) 編程器,我們將繼續進行研發投資。這就是為什麼我們表明,在未來的基礎上,這個數字將更接近中高級青少年。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Brett Fishbin, KeyBanc Capital Markets.

    Brett Fishbin,KeyBanc 資本市場。

  • Brett Fishbin - Analyst

    Brett Fishbin - Analyst

  • Hey, Tim and Rick, thanks so much for fitting me in. I just wanted to ask a follow-up on the hurricane and IV shortage topic. It sounded like you're still working on quantifying the impact on revenue for 4Q? So just curious if you think that, that item is generally de-risked in the implied guidance or if you're still seeing an impact and level of uncertainty even into the month of November?

    嘿,提姆和里克,非常感謝你們讓我加入。我只是想詢問有關颶風和靜脈注射短缺話題的後續情況。聽起來您仍在努力量化對第四季營收的影響?因此,只是好奇您是否認為該項目在隱含指導中通常已降低風險,或者即使到 11 月份您仍然看到影響和不確定性程度?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Yeah. We believe that the recovery effort is well underway, and we tried to build that in, but we do think that is de-risked. I think we see a little bit of the impact late in Q3, obviously, in September, when we got the evacuations and it's really a regionally focused area. And then in the fourth quarter, of course, we got a second hurricane and then the IV shortage. But I think that we're able to kind of address it.

    是的。我們相信復甦工作正在順利進行,我們也試圖將其納入其中,但我們確實認為這已經消除了風險。我認為我們在第三季末看到了一些影響,顯然是在 9 月份,當時我們進行了疏散,這確實是一個以區域為重點的區域。當然,在第四季度,我們遭遇了第二次颶風,然後是 IV 短缺。但我認為我們能夠解決這個問題。

  • Our challenge is going to be just making sure that we have the capacity in the fourth quarter to be able to take care of the patients once they get back into their homes and get back into that healthcare and get rescheduled for their Inspire procedure. So really, for the most part, we're just focused on a local effort.

    我們面臨的挑戰只是確保我們有能力在第四季度有能力照顧患者,一旦他們回到家中並重新接受醫療保健並重新安排他們的 Inspire 手術。所以實際上,在大多數情況下,我們只專注於本地工作。

  • Brett Fishbin - Analyst

    Brett Fishbin - Analyst

  • All right, thank you for that color. And then just for my follow-up. I was wondering if you could comment a bit on how the new centers that you added in the first half of this year have ramped around utilization compared to the typical progressing curve that you've seen in the past? Thank you.

    好吧,謝謝你的顏色。然後只是為了我的後續行動。我想知道您是否可以評論一下您在今年上半年添加的新中心與您過去看到的典型進展曲線相比,利用率如何提高?謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • I think that we always train centers lately with the expectation to be productive when they start. And we want them to make sure they have a number of patients identified. So when we do start them up, they already have patients in the pipeline. And we are straight up with the center of saying it's just -- there's no advantage to yourself to the patients to anybody for you to come on with the intent of not being a productive account. And there's too many accounts that really are pursuing Inspire as part of their offerings. And so we make sure that we screen the sites out. So the intent is that they will move up the utilization matter quickly.

    我認為我們最近總是對中心進行培訓,期望在他們開始時能夠富有成效。我們希望他們確保已經確定了一些患者。因此,當我們啟動它們時,他們已經有患者在準備中。我們直截了當地說,如果你不打算成為一個有生產力的客戶,那麼對你自己、對病人、對任何人都沒有好處。有太多的客戶真正將 Inspire 作為其產品的一部分。因此,我們確保屏蔽這些網站。因此,他們的目的是迅速提高利用率。

  • Now again, it takes time for them to do so. And whether they start earlier in the year, late in the year makes a difference because the way we categorize our classes is our fiscal year. So even if the center starts in December, they're part of that class of 2024. But again, we train them with the intent to be able to have a system to be able to have strong patient flow.

    現在,他們再次需要時間才能做到這一點。無論是在今年早些時候還是在今年晚些時候開始,都會產生影響,因為我們對課程進行分類的方式是我們的財政年度。因此,即使該中心於 12 月開業,他們也屬於 2024 年畢業生。但我們再次培訓他們,目的是能夠擁有一個能夠擁有強大病患流量的系統。

  • Brett Fishbin - Analyst

    Brett Fishbin - Analyst

  • Thank you.

    謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Chris Pasquale, Nephron Research.

    克里斯·帕斯誇萊,腎臟單位研究。

  • Chris Pasquale - Analyst

    Chris Pasquale - Analyst

  • Yeah, thanks for fitting me in. I'll just ask one, Tim. I wanted to follow up on the Inspire V rollout. I imagine customer demand is going to be high once you make that broadly available, you need to retrain the reps and the physicians, how do you execute that transition without taking people out of the field and disrupting procedure volumes? Is it going to be spread out enough across the account base? Is that not an issue or should we be actually expecting some disruption during the first quarter of the full launch?

    是的,謝謝你讓我融入。我只問一個,提姆。我想跟進 Inspire V 的推出。我想一旦你廣泛使用,客戶的需求將會很高,你需要重新培訓代表和醫生,如何在不讓人員離開現場並擾亂手術量的情況下執行這種轉變?它會在整個帳戶群中足夠分散嗎?這不是問題嗎?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • I think it's a little bit of a relative. I think that we can do a lot of the training on logistics management online. But when we get into the surgical training specific aspects of it, as you know, Chris, it's really pretty straightforward in that. We just simply don't implant the pressure sensing lead.

    我覺得有點親戚關係。我認為我們可以在網路上做很多物流管理的訓練。但是,當我們進入外科訓練的具體方面時,正如你所知,克里斯,這確實非常簡單。我們只是簡單地不植入壓力感測引線。

  • And the other avenues that we need to train is how do you do interoperative testing. And then the next training is with a lot of the field clinical reps when we get into the activation. But again, it's still a device replacement going from four to five. So it's a relatively really straightforward training that I don't know if we're going to really need to take all of our people out of the field to be able to do that trade, and we should be able to do that on site.

    我們需要培訓的其他途徑是如何進行互通測試。當我們進入激活階段時,下一個培訓是與許多現場臨床代表一起進行的。但同樣,它仍然是從四台設備更換到五台設備。因此,這是一項相對非常簡單的培訓,我不知道我們是否真的需要將所有人員都帶出現場才能進行這項交易,而且我們應該能夠在現場進行。

  • Chris Pasquale - Analyst

    Chris Pasquale - Analyst

  • Okay, thanks.

    好的,謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Chris.

    謝謝,克里斯。

  • Operator

    Operator

  • Michael Polark, Wolfe Research.

    邁克爾·波拉克,沃爾夫研究中心。

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • Good afternoon. Thank you. Just one for me. I want to confirm on the center additions in the quarter, 66 added, I see the center network up 55% sequentially. So can you confirm there are 11 deactivations

    午安.謝謝。只給我一個。我想確認本季新增的中心數量,增加了 66 個,我看到中心網路環比增長了 55%。那麼您能否確認有 11 次停用

  • Ezgi Yagci - Vice President of Investor Relations

    Ezgi Yagci - Vice President of Investor Relations

  • Yes.

    是的。

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • And can you just remind us what the criteria are to activate some of these centers? Thank you.

    您能否提醒我們激活其中一些中心的標準是什麼?謝謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Sure. I think the number one reason is the surgeon moves to a different facility, and they don't have the ability to offer inspire the therapy. That's primary. Number two, if it's a site that's been inactive, we want to be careful of sending patients to sites where they don't have an opportunity to receive Inspire therapy. So what we do is we take them off the website, we discontinue them.

    當然。我認為第一個原因是外科醫生搬到了不同的機構,他們沒有能力提供啟發性的治療。這是首要的。第二,如果該站點一直處於非活動狀態,我們希望謹慎地將患者送往他們沒有機會接受 Inspire 治療的站點。所以我們要做的就是將它們從網站上刪除,停止它們。

  • A lot of sites we do reactivate. And what happens is they may identify new surgeons that can take care of the patients, and we take them all the way through the training process all over again before we reactivate them. But we make sure that if a center is not able to take to patients that we certainly want to discontinue them.

    我們確實重新激活了很多網站。所發生的情況是,他們可能會找到可以照顧患者的新外科醫生,我們會在重新激活他們之前重新對他們進行整個培訓過程。但我們確保,如果一個中心無法為患者提供服務,我們當然希望停止提供服務。

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Mike Kratky, Leerink Partners.

    麥克‧克拉基 (Mike Kratky),Leerink 合夥人。

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Hi, everyone. Thanks for fitting us in. So following the PREDICTOR data, can you just help us understand to what extent you expect to be able to navigate away from certain patients needing a DISE procedure in 2025? Is that a noticeable tailwind next year? And what are some of the remaining gating factors to be able to see a meaningful impact on your procedure volumes from that?

    大家好。感謝您讓我們融入其中。那麼,根據 PREDICTOR 數據,您能否幫助我們了解您期望在 2025 年能夠在多大程度上擺脫某些需要 DISE 手術的患者?明年這是一個明顯的順風嗎?還有哪些剩餘的門控因素能夠從中看到對您的手術量產生有意義的影響?

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Yeah, I think it is. I think what we want to do is we already have payers that have not specifically -- I'm sorry, we have payers who have already changed their policy to not specifically require a DISE. And that's consistent with our FDA indication that they identify patients that do not have a lateral wall or complete concentric collapse. But they don't specify how that is determined.

    是的,我想是的。我認為我們想要做的是,我們已經有一些付款人沒有特別要求 - 對不起,我們有一些付款人已經改變了他們的政策,不再特別要求 DISE。這與 FDA 的指示一致,即他們識別出沒有側壁或完全同心塌陷的患者。但他們沒有具體說明這是如何決定的。

  • And with the algorithm that we talked about and that you saw down in Miami, that we were able to be able to have physicians start to submit patients into those payers to show that this is an acceptable method to be able to identify which patients are good candidates for Inspire therapy. So I do think it's going to have an impact.

    透過我們討論的演算法以及您在邁阿密看到的演算法,我們能夠讓醫生開始將患者提交給這些付款人,以表明這是一種可以接受的方法,能夠識別哪些患者表現良好Inspire 療法的候選人。所以我確實認為這會產生影響。

  • So we're already working with some physicians to work with their payers and submit patients using the algorithm to be able to determine if they qualify for Inspire and not requiring them to have a sleep endoscopy, and we'll continue to track that and continue to report back.

    因此,我們已經與一些醫生合作,與他們的付款人合作,並使用演算法提交患者,以確定他們是否有資格參加 Inspire,而不要求他們進行睡眠內視鏡檢查,我們將繼續跟踪並繼續報告回來。

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Awesome. Thanks very much.

    驚人的。非常感謝。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Suraj Kalia, Oppenheimer & Co.

    蘇拉吉·卡利亞,奧本海默公司

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Tim and Rick, thanks for squeezing me in. In the interest of time, I'll just ask one question. So Tim, just trying to understand US dynamics. If we normalize Q3 '23, the $10 million that got moved to Q4 '23. We normalized all that, utilization for the last four, five quarters has been relatively flattish. Can you help us reconcile your statement about capacity issues for this Q4? I guess what I'm trying to understand is that utilization is, let's say, 5.7 implants per site per quarter. So you have 65 working days. And somewhere, I'm not understanding your comment about the capacity issue. Even if it's hurricanes, it moves around. But maybe if you can expand on your capacity comments? That would be greatly appreciated. Thank you for taking my questions.

    提姆和里克,謝謝你們讓我參與其中。由於時間關係,我只問一個問題。蒂姆只是想了解美國的動態。如果我們將 23 年第三季標準化,那麼 1000 萬美元就會轉移到 23 年第四季。我們將這一切歸一化,過去四、五季的使用率相對持平。您能否幫助我們協調您關於第四季度容量問題的聲明?我想我想了解的是,利用率是,比方說,每季每個站點 5.7 次植入。所以你有 65 個工作天。在某個地方,我不明白你對容量問題的評論。即使是颶風,它也會移動。但也許您可以擴展一下您的容量評論嗎?我們將不勝感激。感謝您回答我的問題。

  • Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

    Timothy Herbert - Chairman of the Board, President, Chief Executive Officer

  • Absolutely. Thanks, Suraj. Yeah, you asked one question. I thought you're asking four parts. But I think that utilization continues to be our focus. And as you highlight, you spent time with that as well. And I think that as we get into the fourth quarter, we know that there's always a high demand for patients with the high [deductibles] (corrected by company after the call) to be able to increase capacity to be able to take care of those patients.

    絕對地。謝謝,蘇拉吉。是的,你問了一個問題。我以為你問的是四個部分。但我認為利用率仍然是我們的重點。正如您所強調的,您也花了時間在這方面。我認為,當我們進入第四季度時,我們知道對高[免賠額](由公司在通話後糾正)的患者總是有很高的需求,以便能夠增加能力來照顧這些患者患者。

  • And so it's up to our field team to work directly with the surgeons to really make sure that we maximize as much OR time as possible to take care of the high demand that we know we see in the fourth quarter and take care of patients as best as we can. But again, our goal continues to remain that we want to grow adoption and grow same-store sales because we think that, that's going to be an important factor with the specifics of the US market. So thanks very much.

    因此,我們的現場團隊需要直接與外科醫生合作,以真正確保我們最大限度地利用盡可能多的手術時間來滿足我們在第四季度看到的高需求,並儘可能地照顧患者盡我們所能。但我們的目標仍然是希望提高採用率並增加同店銷售額,因為我們認為這將成為美國市場具體情況的重要因素。非常感謝。

  • For everybody, I want to thank you for joining the call today. As always, I'm grateful to the growing team of dedicated Inspire employees for their enthusiasm, hard work, and continued motivation to achieve successful and consistent patient outcomes. The team's commitment to patients remains unmatched and is the most important element to our success. I wish to thank all of our employees as well as the healthcare provider teams for their continued efforts as we remain focused on further expanding our business in the US, Europe, and in Asia.

    對大家來說,我要感謝你們今天加入電話會議。一如既往,我感謝不斷成長的 Inspire 員工團隊的熱情、辛勤工作和持續的動力,以實現成功和一致的患者治療結果。團隊對患者的承諾仍然無與倫比,這是我們成功的最重要因素。我要感謝我們所有員工以及醫療保健提供者團隊的持續努力,因為我們仍然專注於進一步擴大我們在美國、歐洲和亞洲的業務。

  • And for all of you on the call, we appreciate your continued interest and support of Inspire, and we look forward to providing you with further updates in a month ahead. Thank you very much.

    對於所有參加電話會議的人,我們感謝您對 Inspire 的持續關注和支持,我們期待在未來一個月內為您提供進一步的更新。非常感謝。

  • Operator

    Operator

  • Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

    謝謝。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。