Inspire Medical Systems Inc (INSP) 2023 Q2 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 Duluem, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Inspire Medical Systems Second Quarter 2023 Conference Call. (Operator Instructions)

    下午好。我叫 Duluem,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 2023 年第二季度電話會議。 (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 - VP of IR

    Ezgi Yagci - VP of IR

  • Thank you, Duluem, and thank you all for participating in today's call. Joining me are Tim Herbert, President and Chief Executive Officer; and Rick Buchholz, Chief Financial Officer. Earlier today, we released financial results for the three and six months ended June 30, 2023. A copy of the press release is available on our website.

    謝謝杜盧姆,也感謝大家參加今天的電話會議。與我一起的還有總裁兼首席執行官蒂姆·赫伯特 (Tim Herbert);和首席財務官 Rick Buchholz。今天早些時候,我們發布了截至 2023 年 6 月 30 日的三個月和六個月的財務業績。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 2023 financial and operational outlook, and changes in market access are based upon our current estimates and various assumptions. 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 was filed with the SEC earlier this afternoon, for a description of these risks and uncertainties. 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, August 1, 2023.

    在這次電話會議上,管理層將做出聯邦證券法含義內的前瞻性聲明。所有前瞻性陳述,包括但不限於與我們的運營、財務業績和財務狀況、對我們業務的投資、2023 年全年財務和運營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。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存在重大差異。因此,您不應過分依賴這些陳述。請參閱我們向美國證券交易委員會提交的文件,包括今天下午早些時候向美國證券交易委員會提交的 10-Q 表格,了解這些風險和不確定性的描述。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陳述的意圖或義務,無論是由於新信息、未來事件還是其他原因。本次電話會議包含時效性信息,僅在今天(2023 年 8 月 1 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蒂姆·赫伯特。蒂姆?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Thank you, Ezgi, and thanks, everyone, for joining our business update call for the second quarter of 2023. As always, we start with our commitment to patient outcomes and to ensure that each patient has the best possible experience with Inspire therapy. As of the end of the second quarter, over 46,000 patients have been treated with Inspire therapy.

    感謝 Ezgi,感謝大家參加我們 2023 年第二季度的業務更新電話會議。一如既往,我們首先致力於對患者治療結果的承諾,並確保每位患者在 Inspire 治療中獲得最佳體驗。截至第二季度末,已有超過 46,000 名患者接受了 Inspire 療法的治療。

  • Over the past week, we shared some exciting announcements with the additions of Carlton Weatherby as our Chief Strategy Officer and Dr. Charisse Sparks as our Chief Medical Officer. As we continue to expand our business, we need strong leadership to guide the team with our focus on increasing the adoption of Inspire therapy in the obstructive sleep apnea market. OSA is a large and underpenetrated market, and we see many years of sustained, healthy organic growth ahead of us.

    過去一周,我們發布了一些令人興奮的公告,任命 Carlton Weatherby 擔任我們的首席戰略官,Charisse Sparks 博士擔任我們的首席醫療官。隨著我們不斷擴大業務,我們需要強有力的領導來指導團隊專注於增加 Inspire 療法在阻塞性睡眠呼吸暫停市場的採用。 OSA 是一個龐大且滲透率較低的市場,我們預計未來將實現多年持續、健康的有機增長。

  • Carlton joins us from Medtronic, where he was General Manager of the spinal division. He brings a wealth of talent and experience that will be invaluable as we continue to scale our business. Dr. Sparks is a board-certified physician with extensive business and leadership experience, including direct experience with Inspire as a Board Director. She will lead Inspire's clinical program, provide executive oversight to ensure high-quality patient outcomes and serve as a liaison for the ENT and sleep physician communities. In connection with her appointment, Dr. Sparks will transition from her current role on the Inspire Board of Directors. We look forward to Carlton and Charisse's contributions toward our mission of serving the many patients with untreated OSA.

    卡爾頓在加入我們之前曾在美敦力 (Medtronic) 擔任脊柱部門總經理。他帶來了豐富的人才和經驗,隨著我們繼續擴大業務規模,這些人才和經驗將非常寶貴。 Sparks 博士是一位經過董事會認證的醫生,擁有豐富的商業和領導經驗,包括作為 Inspire 董事的直接經驗。她將領導 Inspire 的臨床項目,提供行政監督以確保高質量的患者治療結果,並擔任耳鼻喉科和睡眠醫生社區的聯絡人。根據任命,Sparks 博士將卸任 Inspire 董事會目前的職務。我們期待 Carlton 和 Charisse 為我們為眾多未經治療的 OSA 患者提供服務的使命做出貢獻。

  • With that, let's review our results. In the second quarter, we generated revenue of $151.1 million, representing a 65% increase compared to the second quarter of 2022. Our growth continues to be driven by higher utilization at existing centers and is complemented by the activation of new centers. Given the strong momentum we are seeing in our business, we now expect full revenue to be in the range of $600 million to $610 million, a 47% to 50% increase compared to 2022.

    接下來,讓我們回顧一下我們的結果。第二季度,我們實現了 1.511 億美元的收入,與 2022 年第二季度相比增長了 65%。我們的增長繼續受到現有中心利用率提高的推動,並輔以新中心的啟用。鑑於我們業務的強勁勢頭,我們現在預計總收入將在 6 億至 6.1 億美元之間,比 2022 年增長 47% 至 50%。

  • In the second quarter, we continued to increase our capacity to support the strong demand for Inspire therapy by adding 72 new implanting centers in the U.S., ending the quarter with a total of 1,045 centers. For the remainder of 2023, we continue to expect to activate 52 to 56 centers per quarter.

    第二季度,我們在美國新增了 72 個新的植入中心,繼續提高能力來支持 Inspire 治療的強勁需求,截至本季度末,中心總數達到 1,045 個。在 2023 年剩餘時間內,我們繼續預計每季度將啟動 52 至 56 個中心。

  • Regarding the U.S. sales team, we created 19 new sales territories in the second quarter, bringing our total to 261. We continue to expect to add 12 to 14 U.S. sales territories per quarter for the remainder of 2023.

    關於美國銷售團隊,我們在第二季度創建了 19 個新的銷售區域,使銷售區域總數達到 261 個。我們繼續預計在 2023 年剩餘時間內每季度增加 12 至 14 個美國銷售區域。

  • In the second quarter, the number of visitors to our website surpassed 2.9 million. From these visits, we had over 12,000 physician contacts. And even with the typical summer slowdown in contacts, we steadfastly improved our conversion of patients receiving therapy. We continue to make numerous changes to our website to enhance how patients engage with our Advisor Care Program, and we have a new website design in the works for later this year. Further, we are continuing to increase the use of digital scheduling for Inspire consultation through our ACP.

    第二季度,我們網站的訪問者數量超過 290 萬人。通過這些訪問,我們接觸了超過 12,000 名醫生。儘管夏季接觸人數普遍減少,但我們仍堅定不移地提高了接受治療的患者的轉化率。我們繼續對我們的網站進行大量更改,以增強患者參與我們的顧問護理計劃的方式,並且我們將於今年晚些時候進行新的網站設計。此外,我們將繼續通過 ACP 增加數字化日程安排的使用,以進行 Inspire 諮詢。

  • We previously mentioned one of the limiting factors to the adoption of Inspire therapy is the capacity of ENT surgeons performing the procedure. To this end, we are focusing on providing robust training programs to new physicians and reducing the time required to qualify and support patients through the entire Inspire journey. We believe that both of these focus areas will provide implanting surgeons with additional time to perform Inspire procedures.

    我們之前提到過採用 Inspire 療法的限制因素之一是耳鼻喉科醫生執行手術的能力。為此,我們致力於為新醫生提供強有力的培訓計劃,並減少在整個 Inspire 旅程中獲得資格和支持患者所需的時間。我們相信,這兩個重點領域將為植入外科醫生提供更多時間來執行 Inspire 手術。

  • One example to improve the patient experience and reduce the time burden of the surgeon is our ongoing PREDICTOR study, which is designed to replace a drug-induced sleep endoscopy, or DISE, with an office-based airway exam. We have completed the data quality checks from the first 300 patients and are actively enrolling the second group of 300 patients with a higher BMI. We will be moving towards preparing a publication from the first data set and expect that these results will be presented in the fall.

    我們正在進行的 PREDICTOR 研究是改善患者體驗並減少外科醫生時間負擔的一個例子,該研究旨在用辦公室氣道檢查取代藥物誘導的睡眠內窺鏡檢查 (DISE)。我們已經完成了前 300 名患者的數據質量檢查,並正在積極招募第二組 300 名 BMI 較高的患者。我們將著手根據第一個數據集準備出版物,並預計這些結果將在秋季公佈。

  • Another example relates to the growing adoption of the sleep SleepSync(TM) patient management system. SleepSync(TM) is designed to streamline the patient journey from initial contact through diagnosis, system implant and post-procedural longitudinal patient management. The utility of this platform continues to improve, as is highlighted by the recent launch of the Inspire Bluetooth-enabled patient remote, which is the link between the patient's device and SleepSync(TM).

    另一個例子涉及睡眠 SleepSync(TM) 患者管理系統的日益普及。 SleepSync(TM) 旨在簡化患者從初次接觸到診斷、系統植入和術後縱向患者管理的整個過程。該平台的實用性不斷提高,最近推出的支持藍牙功能的 Inspire 患者遙控器就凸顯了這一點,該遙控器是患者設備和 SleepSync(TM) 之間的鏈接。

  • The next step is our new physician programmer called the SleepSync(TM) programmer, which was approved by FDA in the second quarter and will formally launch in the U.S. in early 2024. The SleepSync(TM) programmer allows physicians and their staff to log in from their own computer to access the programming screens and view all patient activity stored in the SleepSync(TM) system. Once launched, this technology will remove the necessity for Inspire to provide tablets as part of the physician programming system and will pave the way for future remote patient programming.

    下一步是我們新的醫師編程器,稱為SleepSync(TM) 編程器,該編程器於第二季度獲得FDA 批准,並將於2024 年初在美國正式推出。SleepSync(TM) 編程器允許醫生及其員工登錄從他們自己的計算機訪問編程屏幕並查看存儲在 SleepSync(TM) 系統中的所有患者活動。一旦推出,這項技術將消除 Inspire 提供平板電腦作為醫生編程系統一部分的必要性,並將為未來的遠程患者編程鋪平道路。

  • Staying with product development, the Inspire V team is excited to announce the submission of our PMA supplement to the FDA. Subject to the FDA's review process, we expect approval in early 2024. Recall, Inspire V incorporates the sensor inside the neurostimulator using an accelerometer to measure respiration and will eliminate the need for the pressure sensing lead. Further, Inspire V is a platform device, which will enable firmware upgrades, transitioning to Inspire VI and beyond, whereby further product enhancements such as auto-activation will be introduced.

    繼續進行產品開發,Inspire V 團隊很高興地宣布向 FDA 提交我們的 PMA 補充劑。根據 FDA 的審查流程,我們預計將於 2024 年初獲得批准。回想一下,Inspire V 將傳感器集成在神經刺激器內,使用加速度計來測量呼吸,並將消除對壓力傳感引線的需要。此外,Inspire V是一個平台設備,將支持固件升級,過渡到Inspire VI及更高版本,從而引入自動激活等進一步的產品增強功能。

  • From a research, clinical and regulatory viewpoint, in the second quarter, we received FDA approval to expand our indication to include patients with an AHI up to 100 events per hour, up from 65, and raised the BMI warning in the labeling from 32 to 40. Furthermore, we are happy to announce that the ADHERE registry has met its target of 5,000 patients. And moving forward, patients will be enrolled into the ADHERE 2.0 registry, which will be integrated into the SleepSync(TM) system and included as part of a broader software release later this year.

    從研究、臨40. 此外,我們很高興地宣布 ADHERE 登記處已經實現了 5,000 名患者的目標。展望未來,患者將被納入 ADHERE 2.0 註冊表,該註冊表將集成到 SleepSync(TM) 系統中,並作為今年晚些時候更廣泛的軟件版本的一部分。

  • A quick comment on reimbursement as the new proposed OPPS rules were recently published and showed an increase to the national Medicare payment to hospitals of about $1,000 to $30,355 and an increase for ASCs of about $300 to $25,470. We also highlight the significant increase in the reimbursement of the DISE procedure, which increased from $180 to $1,639 for the Medicare facility payment. We do see a slight reduction in the physician payment proposed, but this is tied to the overall RVU rate, which typically rebounds by the final November rules.

    最近發布了新的 OPPS 規則提案,對報銷進行了快速評論,顯示向醫院支付的國家醫療保險費用增加了約 1,000 美元至 30,355 美元,ASC 費用增加了約 300 美元至 25,470 美元。我們還強調 DISE 程序的報銷顯著增加,醫療保險設施付款從 180 美元增加到 1,639 美元。我們確實看到擬議的醫生付款略有減少,但這與總體 RVU 率相關,通常會在 11 月最終規則出台後反彈。

  • Today, ASCs continue to make up about 23% of our total number of centers. But longer term, we continue to see the Inspire therapy migrate more to the ASC setting, but this is challenged by the varying Medicare reimbursement rates in different states. We also have seen a stronger rebound in Medicare cases over the last 2 quarters, and with the Medicare reimbursement rates lower, especially in the South, this is limiting Medicare cases to the hospital outpatient setting. While we are able to obtain sufficient OR time in hospitals, our long-term programs will focus on ASC reimbursement and education for ASCs as we see this as an efficient site of service for the Inspire procedure. Finally, while we are very happy with the strong Medicare rebound, we expect that the balance will shift more heavily towards commercial cases as we progress through the year.

    如今,ASC 仍然占我們中心總數的 23% 左右。但從長遠來看,我們繼續看到 Inspire 療法更多地遷移到 ASC 環境,但這受到不同州不同的醫療保險報銷率的挑戰。我們還看到過去兩個季度醫療保險案件出現強勁反彈,並且隨著醫療保險報銷率較低(尤其是在南方),這將醫療保險案件限制在醫院門診環境中。雖然我們能夠在醫院獲得足夠的手術室時間,但我們的長期計劃將側重於 ASC 報銷和 ASC 教育,因為我們認為這是 Inspire 手術的高效服務場所。最後,雖然我們對醫療保險的強勁反彈感到非常高興,但我們預計,隨著今年的進展,平衡將更多地轉向商業案件。

  • Switching over to our international business, the European team achieved a very successful second quarter, growing 81% over the prior year. This robust growth was driven by a strong performance in Germany and supported by the Netherlands and Switzerland. We are very excited about the strength we are seeing in Belgium, which finalized countrywide reimbursement earlier this year and look forward to building momentum in the quarters ahead. We are also excited about our new country manager in France, and we continue to prepare for a full market launch there, pending the final reimbursement announcement expected later this year. Finally, we have made progress with reimbursement in the United Kingdom and expect additional patients receiving Inspire therapy in this region.

    轉向我們的國際業務,歐洲團隊在第二季度取得了非常成功的業績,比上一年增長了 81%。這一強勁增長是由德國的強勁表現推動的,並得到荷蘭和瑞士的支持。我們對比利時的實力感到非常興奮,比利時於今年早些時候完成了全國范圍內的報銷,並期待在未來幾個季度建立勢頭。我們也對法國新任國家經理感到興奮,我們將繼續為法國的全面市場啟動做準備,等待預計今年晚些時候發布的最終報銷公告。最後,我們在英國的報銷方面取得了進展,並期望該地區有更多患者接受 Inspire 治療。

  • In Asia, we are seeing great momentum in Singapore with procedures showing significant growth, both sequentially and year-over-year. In Japan, we continue to advance our efforts of going direct by hiring and training additional team members, have completed the Japanese website and are seeing increased activity with physicians and active centers.

    在亞洲,我們看到新加坡的強勁勢頭,其手術無論是環比還是同比都顯示出顯著增長。在日本,我們通過僱用和培訓更多團隊成員繼續推進直接努力,已經完成了日本網站,並看到與醫生和活動中心的活動有所增加。

  • Regarding operations, we continue to make progress with the production ramp of the silicone-based stimulation and sensing leads. We remain in a challenged position with the sensor manufacturing yields. However, we have incorporated a recent manufacturing change and expect to grow inventory as we move through the quarter. We remain in a positive inventory position with short-term plans in place to grow to our goal of one quarter of safety stock by year-end. We feel good about our inventory position in our other products.

    在運營方面,我們在矽基刺激和傳感引線的生產上繼續取得進展。我們在傳感器製造產量方面仍然面臨挑戰。然而,我們已經納入了最近的製造變革,並預計隨著本季度的推移,庫存將會增加。我們仍然保持積極的庫存狀況,並製定了短期計劃,以在年底前實現四分之一安全庫存的目標。我們對其他產品的庫存狀況感覺良好。

  • In summary, we continue to see significant momentum in our business. We remain focused on patient outcomes and physician education to continue the adoption of our therapy. We will continue to increase utilization at our existing centers, while adding capacity by opening new centers. We remain extremely excited about our future prospects and are confident that we have the appropriate strategy in place to drive long-term stakeholder value.

    總而言之,我們的業務繼續保持強勁勢頭。我們仍然關注患者的治療結果和醫生教育,以繼續採用我們的療法。我們將繼續提高現有中心的利用率,同時通過開設新中心來增加容量。我們對未來的前景仍然感到非常興奮,並相信我們有適當的戰略來推動利益相關者的長期價值。

  • 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 J. Buchholz - CFO

    Richard J. Buchholz - CFO

  • Thank you, Tim, and good afternoon, everyone. Total revenue for the second quarter was $151.1 million, a 65% increase from the $91.4 million generated in the second quarter of 2022. U.S. revenue in the second quarter was $144.7 million, an increase of 65% from the $87.9 million in the prior year period. The primary growth driver in the U.S. was higher utilization at existing centers. Other growth drivers include the addition of new implanting centers, our continuing direct-to-consumer marketing and a higher number of territory managers.

    謝謝蒂姆,大家下午好。第二季度總收入為 1.511 億美元,比 2022 年第二季度的 9140 萬美元增長 65%。 第二季度美國收入為 1.447 億美元,比上年同期的 8790 萬美元增長 65% 。美國的主要增長動力是現有中心利用率的提高。其他增長動力包括增加新的植入中心、我們持續的直接面向消費者的營銷以及更多的區域經理。

  • We are pleased to announce revenue outside the U.S. increased to $6.3 million, which is an 81% increase year-over-year on a reported basis, while units sold outside the U.S. grew 72%.

    我們很高興地宣布,美國境外的收入增至 630 萬美元,據報告,同比增長 81%,而美國境外的銷量增長 72%。

  • The U.S. average selling price in the second quarter was $25,000 compared to $24,100 in the prior year period. The increase reflects our 5% price uplift that began in May of 2022. We expect the U.S. ASP to remain steady at the current level.

    第二季度美國平均售價為 25,000 美元,而去年同期為 24,100 美元。此次上漲反映了我們從 2022 年 5 月開始的 5% 價格上漲。我們預計美國平均售價將保持穩定在當前水平。

  • The ASP outside the U.S. was $22,100 during the quarter compared to $21,000 in the second quarter of 2022.

    本季度美國以外地區的平均售價為 22,100 美元,而 2022 年第二季度為 21,000 美元。

  • Gross margin in the second quarter was 83.9% compared to 84.5% in the prior year period, primarily due to additional manufacturing costs of sensors and lower yields prior to process enhancements, as well as higher cost of certain component parts, partially offset by the price increase, which is now fully in effect.

    第二季度的毛利率為 83.9%,而上年同期為 84.5%,主要是由於傳感器的額外製造成本和工藝改進之前的產量下降,以及某些零部件的成本較高,部分被價格所抵消增加,現已完全生效。

  • Total operating expenses for the second quarter were $143.4 million, an increase of 57% as compared to $91.2 million in the second quarter of 2022. This planned increase was due to the expansion of our sales organization, increased direct-to-consumer marketing programs, continued product development efforts and general corporate costs. The increase in operating expenses is reflective of our ongoing plan to drive continued long-term growth and to make investments in key areas of our business.

    第二季度的總運營費用為 1.434 億美元,較 2022 年第二季度的 9120 萬美元增長 57%。這一計劃增長是由於我們銷售組織的擴張、直接面向消費者的營銷計劃的增加、持續的產品開發工作和一般企業成本。運營費用的增加反映了我們正在進行的計劃,以推動持續的長期增長並在我們業務的關鍵領域進行投資。

  • Interest and dividend income totaled $4.9 million in the second quarter compared to $297,000 in the prior year period. This higher income was driven by higher interest rates on our increased cash balances compared to a year ago.

    第二季度利息和股息收入總計 490 萬美元,而去年同期為 297,000 美元。與一年前相比,我們增加的現金餘額帶來了更高的利率,從而推動了收入的增加。

  • Net loss for the second quarter was $12 million compared to $14.5 million net loss in the prior year period. The net loss per share was $0.41 compared to $0.53 in the second quarter of 2022. The net loss for the second quarter includes $3 million of R&D expenses associated with prelaunch inventory related to Inspire V that is expensed for accounting purposes.

    第二季度淨虧損為 1200 萬美元,而上年同期淨虧損為 1450 萬美元。每股淨虧損為0.41 美元,而2022 年第二季度為0.53 美元。第二季度淨虧損包括與Inspire V 相關的上市前庫存相關的300 萬美元研發費用,該費用出於會計目的而計入費用。

  • The weighted average number of shares outstanding for the second quarter was 29.2 million. We expect the third quarter weighted average shares outstanding to be approximately 29.4 million.

    第二季度流通股加權平均數為2920萬股。我們預計第三季度加權平均流通股約為 2940 萬股。

  • Given our continued operating leverage improvement, our cash and investments increased to $467 million at June 30 from $452 million at March 31. This strong cash position allows us to remain focused on executing our growth strategy of increasing procedure volumes at existing centers, while training and opening new implanting centers.

    鑑於我們的經營槓桿持續改善,我們的現金和投資從3 月31 日的4.52 億美元增加到6 月30 日的4.67 億美元。這種強勁的現金狀況使我們能夠繼續專注於執行增加現有中心手術量的增長戰略,同時培訓和培訓開設新的植入中心。

  • Moving on to updated 2023 guidance, given the strong momentum we are seeing in our business, we now expect full year revenue to be in the range of $600 million to $610 million, an increase from our previous guidance of $580 million to $590 million. This updated revenue guidance represents 47% to 50% growth compared to full year 2022 revenue. Similar to prior years, as we progress through the second half of the year, we generally see increased seasonality in the fourth quarter as patients and physicians attempt to schedule Inspire procedures before high deductible health plans reset at the beginning of the year.

    接下來是更新的 2023 年指導,鑑於我們業務的強勁勢頭,我們現在預計全年收入將在 6 億至 6.1 億美元之間,高於之前的 5.8 億至 5.9 億美元指導。與 2022 年全年收入相比,更新後的收入指引意味著 47% 至 50% 的增長。與往年類似,隨著下半年的進展,我們通常會看到第四季度的季節性增加,因為患者和醫生試圖在年初重置高免賠額健康計劃之前安排 Inspire 程序。

  • We continue to expect full year gross margin to be in the range of 83% to 85%. As Tim noted, we expect to activate 52 to 56 new U.S. centers per quarter and establish 12 to 14 new U.S. sales territories per quarter for the remainder of 2023. In conclusion, our strong performance and business momentum provide us with confidence in our outlook for the remainder of 2023.

    我們繼續預計全年毛利率將在 83% 至 85% 之間。正如Tim 指出的那樣,我們預計在2023 年剩餘時間內,每季度將啟動52 至56 個新的美國中心,並每季度建立12 至14 個新的美國銷售地區。總而言之,我們強勁的業績和業務勢頭使我們對未來的前景充滿信心。 2023 年剩餘時間。

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

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

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Jonathan David Block - MD & Senior Equity Research Analyst

    Jonathan David Block - MD & Senior Equity Research Analyst

  • It's Jon from Stifel. I didn't hear the beginning, but maybe I'll go. I'm going to ask both upfront. GLP-1, there's certainly a lot of chatter or concerns. So Tim, maybe sort of big picture, how do you view this playing out for the company's TAM? And has the funnel altered materially to the upside or the downside, arguably, from your view?

    我是來自斯蒂菲爾的喬恩。我沒聽到開頭,但也許我會去。我要提前問清楚。 GLP-1,肯定有很多討論或擔憂。 Tim,也許是一個大局,您如何看待這對公司的 TAM 的影響?從您的角度來看,漏斗是否發生了重大的上行或下行變化?

  • And then the second question, maybe more specific to the quarter P&L, I've been following you guys for a while, and international usually doesn't get a lot of play, but that's a big growth number. I know you've been working on the opportunity for some time. Was there anything specific to the second quarter? Or is this arguably an inflection point for the OUS business that you see going forward?

    然後是第二個問題,也許更具體地說是季度損益表,我關注你們一段時間了,國際業務通常不會得到很多關注,但這是一個很大的增長數字。我知道你已經為這個機會努力了一段時間了。第二季度有什麼特別的事情嗎?或者,這可以說是您認為未來 OUS 業務的拐點嗎?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • We're happy with GLP-1. We think it's complementary to Inspire. Again, it's very specifically discussed that the Inspire mechanism of action is to move the tongue base forward. We don't address lateral wall collapse that is associated with higher BMI patients. We've talked about this before. When patients go on a GLP-1 drug and they lose weight, they tend to lose the weight in the neck circumference, which is addressed by lateral wall collapse, which is outside of our mechanism of action.

    我們對 GLP-1 感到滿意。我們認為它是 Inspire 的補充。再次,非常具體地討論了 Inspire 的作用機制是向前移動舌根。我們不解決與 BMI 較高的患者相關的側壁塌陷問題。我們之前已經討論過這個問題。當患者服用 GLP-1 藥物並且體重減輕時,他們往往會減輕頸圍的重量,這是通過側壁塌陷來解決的,這不屬於我們的作用機制。

  • Therefore, if we can get higher BMI patients to lose weight, it will relax the lateral walls, and there will be predominantly tongue-based obstruction, which is highly effectively treated with Inspire by stimulation of the hypoglossal nerve. So again, 2 different mechanisms of action being treated by GLP-1 and Inspire and very complementary to each of them. We do have our own research project to address lateral wall collapse, but that's a longer-term solution. But in the meantime, if we can see progress with the GLP-1 drugs helping patients lose weight and moving them towards the Inspire indication, it's going to be highly beneficial.

    因此,如果我們能讓BMI較高的患者減肥,就會導致側壁鬆弛,主要出現舌部梗阻,而Inspire通過刺激舌下神經可以非常有效地治療這種情況。同樣,GLP-1 和 Inspire 處理兩種不同的作用機制,並且它們各自非常互補。我們確實有自己的研究項目來解決側壁倒塌問題,但這是一個長期的解決方案。但與此同時,如果我們能夠看到 GLP-1 藥物在幫助患者減肥並使他們走向 Inspire 適應症方面取得進展,那將是非常有益的。

  • At this point, it's a little early. So we haven't seen a lot of movement out in the field. We don't hear a lot of feedback from our physicians, but we welcome the opportunity to take care of the patients as they start to lose weight.

    現在看來,還有些早。因此,我們還沒有看到該領域有太多進展。我們沒有聽到醫生的太多反饋,但我們很高興有機會在患者開始減肥時照顧他們。

  • International is exciting. And I think we've seen some great progress in international. Jon, you've been following Inspire for quite some time. And what we've always said is we don't make strong investments in a country until we've established a reimbursement pathway in that country. And in the case of Germany, we've had great success there. And as we're coming out of COVID, now we're seeing a strong rebound. Germany had a very good quarter. The Netherlands overcame some reimbursement challenges and are opening up new centers, which provide growth there.

    國際化是令人興奮的。我認為我們在國際上已經看到了一些巨大的進步。喬恩,您關注 Inspire 已經有一段時間了。我們一直說的是,在一個國家建立報銷途徑之前,我們不會在該國家進行大量投資。就德國而言,我們在那裡取得了巨大的成功。隨著我們走出新冠疫情,我們現在看到了強勁的反彈。德國這個季度表現非常好。荷蘭克服了一些報銷挑戰,正在開設新的中心,從而促進了那裡的增長。

  • But the exciting news is in Belgium that completed the countrywide reimbursement. They will have a strong second half as they start to schedule their cases. And we already have the announcement on countrywide reimbursement in France, and we expect the new coding to come out relatively soon, so we can do a full launch there. So a lot going on in the international markets. We really like what's happening. The team is well organized. And then in the Asia market, Singapore, as we said, is doing well. And going direct in Japan is really starting to show good progress, and we look forward to reporting more activity there in the future.

    但令人興奮的消息是比利時完成了全國范圍內的報銷。當他們開始安排案件時,他們將有一個強勁的下半年。我們已經在法國宣布了全國范圍內的報銷,我們預計新編碼將很快發布,這樣我們就可以在那裡全面啟動。國際市場上發生了很多事情。我們真的很喜歡正在發生的事情。團隊組織良好。然後在亞洲市場,正如我們所說,新加坡表現良好。在日本的直接行動確實開始顯示出良好的進展,我們期待著將來報告更多的活動。

  • Operator

    Operator

  • And I show our next question comes from the line of Robbie Marcus from JPMorgan.

    我將展示我們的下一個問題來自摩根大通的羅比·馬庫斯。

  • Robert Justin Marcus - Analyst

    Robert Justin Marcus - Analyst

  • Congrats on a really nice quarter here. Maybe to start, you recently had the label updated. You can treat more episodes per night, more severe sleep apnea, and the BMI raised to 40. Can you talk about what you're seeing as an impact in the field and how much this can really increase your addressable market? And I guess you touched on it in the last with GLP-1, but I imagine it probably helps a whole lot with the combination of the 2 going forward.

    祝賀這裡度過了一個非常美好的季度。也許首先,您最近更新了標籤。您可以每晚治療更多次發作、更嚴重的睡眠呼吸暫停,並將BMI 提高到40。您能談談您認為對該領域的影響是什麼,以及這可以在多大程度上真正增加您的潛在市場?我猜你在最後的 GLP-1 中談到了它,但我想它可能對未來兩者的結合有很大幫助。

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Absolutely. As far as the label updates go, also remember, we recently received a pediatric approval for Down syndrome, and that is going along well, and we're opening up more children's facilities. Most of those facilities are already tied in with existing Inspire centers so we can take care of those kids. The label update for AHI is a pretty immediate introduction because there's just not a lot of options for those patients that have a higher apnea-hypopnea index above 65 going up to 100. And so that really helps us get the approval with the insurance companies. So that's a pretty immediate return. We're going to see a little bit increase in procedures right there.

    絕對地。就標籤更新而言,還請記住,我們最近獲得了針對唐氏綜合症的兒科批准,進展順利,我們正在開放更多兒童設施。大多數設施已經與現有的 Inspire 中心相連,因此我們可以照顧這些孩子。 AHI 的標籤更新是一個非常直接的介紹,因為對於那些呼吸暫停低通氣指數高於 65 至 100 的患者來說,沒有太多選擇。因此,這確實有助於我們獲得保險公司的批准。所以這是一個非常直接的回報。我們將看到那裡的程序有所增加。

  • BMI, we got to be a little bit careful about because just bringing in a BMI patient up to a BMI of 40 is a little dangerous because the probability of them having lateral wall collapse, which again, that presents as a complete concentric collapse when you do a DISE procedure -- and remember, we treat tongue-based obstructions with the anterior-posterior with the tongue moving forward. So with higher BMI, we're being very careful to not fill the appointment books of the ENT surgeons with high BMI patients who won't qualify for Inspire anyways. Now those are the patients that will be good patients to get on the GLP-1 drugs, if you will, to help them lose some weight, relax the lateral walls and allow us to assess if they,or tongue-based collapse that can be properly treated with Inspire.

    BMI,我們必須要小心一些,因為僅僅將 BMI 達到 40 的 BMI 患者引入就有點危險,因為他們有可能出現側壁塌陷,同樣,當您將其表現為完全同心塌陷時,進行DISE 手術- 請記住,我們通過舌頭向前移動的方式來治療舌部阻塞。因此,對於 BMI 較高的患者,我們會非常小心,不要將 BMI 較高的患者填滿耳鼻喉科醫生的預約簿,因為他們無論如何都不符合 Inspire 的資格。現在,這些患者將是接受 GLP-1 藥物的好患者,如果您願意的話,可以幫助他們減輕一些體重,放鬆側壁,並讓我們評估他們是否可以治療舌基塌陷。使用 Inspire 進行正確處理。

  • So to summarize, the AHI is going to be an indication expansion. I think in the past, we've talked about it being about a 10% increase over our published TAM. BMI, we're going to be careful about because the current system doesn't treat lateral wall, but we now have the advantage of the GLP-1 to be able to address of that market as well, albeit they need to lose the weight first, and we know that takes a little bit of time with the drugs.

    總而言之,AHI 將是一個適應症擴展。我想在過去,我們曾討論過比我們發布的 TAM 增加了 10% 左右。 BMI,我們要小心,因為當前的系統不治療側壁,但我們現在擁有 GLP-1 的優勢,也能夠解決該市場的問題,儘管他們需要減輕體重首先,我們知道這需要一點時間來服用藥物。

  • Robert Justin Marcus - Analyst

    Robert Justin Marcus - Analyst

  • And maybe one on spending, you called out, I think it was $3 million or so in Inspire V buildup in inventory and R&D accounts for a lot of the step-up. But maybe just give us an update on how you're thinking about balancing the great top line growth versus margin leverage and views on profitability going forward.

    也許是關於支出,你喊道,我認為 Inspire V 的庫存積累約為 300 萬美元,而研發佔了很大一部分。但也許您可以向我們提供最新信息,說明您如何考慮平衡巨大的營收增長與利潤槓桿以及對未來盈利能力的看法。

  • Richard J. Buchholz - CFO

    Richard J. Buchholz - CFO

  • Robbie, it's Rick. So yes, we understand profitability is important, and we continue to create leverage in our P&L. But our real focus is top line growth and growing the adoption. So we do invest in a disciplined manner. We continue to do that. We've made investments in DTC, R&D and all areas of our business, but we have been improving our leverage on our operating expenses. R&D is 20% of revenue. It was 20% of revenue in the first quarter. We've talked about the fact that we expect that to be in the high-teens or so but we're making tremendous investments, as Tim talked about in the prepared remarks.

    羅比,我是瑞克。所以,是的,我們知道盈利能力很重要,並且我們繼續在損益表中創造槓桿。但我們真正的重點是收入增長和提高采用率。因此,我們確實以嚴謹的方式進行投資。我們將繼續這樣做。我們在 DTC、研發和所有業務領域進行了投資,但我們一直在提高運營支出的槓桿率。研發佔收入的20%。佔第一季度收入的20%。我們已經討論過這樣一個事實,即我們預計這一數字將在十幾歲左右,但正如蒂姆在準備好的講話中談到的那樣,我們正在進行巨大的投資。

  • But we actually, in the second quarter, given the current macro supply chain environment and our confidence in Inspire V approval in 2024, we are purchasing some Inspire V components now. But for accounting purposes, it must be recorded as an R&D expense. I don't mean to get into the fine details of that, but that accounted for 200 basis points of our R&D as a percentage of revenue. That being said, stock-based compensation is a big number. In the quarter, it was nearly $22 million. And so taking that out, we've generated cash. We're cash positive by $15 million. So profitability will come. We haven't changed our tone on that, but we're really focused on the long-term top line growth.

    但實際上,在第二季度,考慮到當前的宏觀供應鏈環境以及我們對 2024 年 Inspire V 獲得批准的信心,我們現在正在採購一些 Inspire V 組件。但出於會計目的,必須將其記錄為研發費用。我無意深入探討其中的細節,但這占我們研發收入的 200 個基點的百分比。話雖這麼說,股票薪酬是一個很大的數字。該季度的銷售額接近 2200 萬美元。因此,除去這些,我們就產生了現金。我們的現金為 1500 萬美元。那麼盈利能力就會到來。我們對此的基調沒有改變,但我們真正關注的是長期的收入增長。

  • Operator

    Operator

  • And I show our next question comes from the line of Danielle Antalffy from UBS.

    我將展示我們的下一個問題來自瑞銀集團 (UBS) 的丹妮爾·安塔菲 (Danielle Antalffy)。

  • Danielle Joy Antalffy - Analyst

    Danielle Joy Antalffy - Analyst

  • Congrats on a really strong quarter. It's great to see. I just wanted to ask a follow-up question on the Medicare, the shift in patients a little bit away from Medicare patients given the proposed physician payment. So the first question I have is what percentage of your patients today are Medicare and then what percentage of overall OSA patients are Medicare? And also how we should think about this going forward? Is this really meaningful? Or is this just you guys being cautious?

    祝賀這個季度的強勁表現。很高興看到。我只是想問一個有關醫療保險的後續問題,考慮到擬議的醫生付款,患者與醫療保險患者之間的關係發生了一些變化。因此,我的第一個問題是,現在您的患者中有多少百分比享受醫療保險,然後佔 OSA 患者總數的多少百分比享受醫療保險?我們未來應該如何思考這個問題?這真的有意義嗎?還是說這只是你們謹慎的表現?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Sure. Danielle, I think the Medicare -- historically, our blend has always been about 65% to 70% commercial, 25% to 30% Medicare and about 5% VA or military, and that probably purposely doesn't add up to 100. But as we've seen in the last couple of quarters, we saw a good Medicare rebound. Usually, in Q1, we see heavy Medicare because we have the high commercial in Q4, again, going back to the high deductible insurance plans. And so in Q1, Q2, we just saw a higher percent, not quite 50% but approaching it for Medicare. So while that's really exciting for that population, it does put some challenges to the reimbursement in ASCs, and that's kind of what we're highlighting.

    當然。丹妮爾,我認為醫療保險——從歷史上看,我們的混合一直是大約65% 到70% 商業、25% 到30% 醫療保險和大約5% VA 或軍事,這可能故意不加起來為100。但是正如我們在過去幾個季度所看到的,我們看到醫療保險出現了良好的反彈。通常,在第一季度,我們會看到大量醫療保險,因為我們在第四季度有很高的商業成本,再次回到高免賠額保險計劃。因此,在第一季度、第二季度,我們看到醫療保險的比例較高,雖然不是 50%,但已接近這一比例。因此,雖然這對這些人群來說確實令人興奮,但它確實給 ASC 的報銷帶來了一些挑戰,這正是我們所強調的。

  • We're able to handle and cover those cases all in a hospital setting or in ASCs in the north, but that does present a longer-term challenge. As we progress into Q3 and certainly into Q4, as Rick highlighted, it becomes more weighted towards commercial cases because, again, the high deductibles really kind of drive the fourth quarter. So I would expect our percentages to move back to more traditional ratios. And then overall, obstructive sleep apnea is a young person's disease. And in the clinical studies, we saw the average age of our studies was down at 54.

    我們能夠在醫院環境或北部的 ASC 中處理和承保這些病例,但這確實帶來了長期挑戰。正如里克所強調的那樣,隨著我們進入第三季度,當然也進入第四季度,商業案例變得更加重要,因為高免賠額確實推動了第四季度的發展。因此,我預計我們的百分比將恢復到更傳統的比率。總的來說,阻塞性睡眠呼吸暫停是年輕人的疾病。在臨床研究中,我們發現研究的平均年齡下降至 54 歲。

  • During the early commercial years, of course, reimbursement is easy with Medicare. So it kind of rises up a little bit. But we think that it should be back in the average age in the 50s. Remember, now we have the pediatric approval. The youngest person is really just single digits years of age. So we're across the board on treating patients. But for the most part, I think that we want to keep our ratios focused on the commercial side, certainly complementary with Medicare and always provide service to the VA and military.

    當然,在商業早期,通過醫療保險報銷是很容易的。所以它有點上升。但我們認為應該回到50多歲的平均年齡。請記住,現在我們已獲得兒科批准。最小的人實際上只有個位數歲數。因此,我們正在全面治療患者。但在大多數情況下,我認為我們希望將我們的比率集中在商業方面,當然與醫療保險互補,並始終為退伍軍人管理局和軍隊提供服務。

  • Danielle Joy Antalffy - Analyst

    Danielle Joy Antalffy - Analyst

  • Okay. Got it. And then Inspire V, congrats on that. Once that is approved, should we think about that as a gradual rollout? Or how should we think about building capacity of Inspire V ahead of the launch and potential impact to margins there?

    好的。知道了。然後是 Inspire V,恭喜你。一旦獲得批准,我們是否應該將其視為逐步推出?或者我們應該如何考慮 Inspire V 在推出之前的產能建設以及對利潤率的潛在影響?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • I think people are excited about Inspire V. Obviously, the removal of the pressure sensing lead is an improvement for the patient and it makes the procedure more comfortable for an ear, nose and throat surgeon to perform. It also provides improved reliability as, even though we have a small number of revision surgeries, the culprit for most of those is that pressure sensing lead. So we want to be able to get this out broadly in the market as soon as we can. Once approved, I'm sure we'll do a small pilot study just to make sure it works well with all the SleepSync(TM) system, the new remotes and the adoption into the market. And by midyear, we expect to go full launch on this. And we believe once launched, it will be a very quick transition across the board.

    我認為人們對 Inspire V 感到興奮。顯然,壓力傳感引線的移除對患者來說是一種進步,它使耳鼻喉外科醫生執行手術時更加舒適。它還提供了更高的可靠性,因為即使我們進行了少量的翻修手術,但大多數手術的罪魁禍首是壓力傳感引線。因此,我們希望能夠盡快將其廣泛推向市場。一旦獲得批准,我確信我們將進行一項小型試點研究,以確保它能夠與所有 SleepSync(TM) 系統、新遙控器以及市場採用良好配合。到年中,我們預計將全面啟動此功能。我們相信,一旦啟動,這將是一個非常快速的全面過渡。

  • Operator

    Operator

  • And I show our next question comes from the line of Travis Steed from Bank of America Securities.

    我將展示我們的下一個問題來自美國銀行證券公司的特拉維斯·斯蒂德 (Travis Steed)。

  • Travis Lee Steed - MD

    Travis Lee Steed - MD

  • Congrats on a good quarter. Maybe the hospital outpatient reimbursement that came out recently, there was a big uptick in DISE procedures and a few things with the reimbursement going up on the replacement of the leads to be replaced. Just curious how you're seeing that, if that was expected, and how that should play out in the business?

    祝賀季度表現良好。也許是最近推出的醫院門診報銷,DISE 程序大幅增加,並且更換導線的報銷也有所增加。只是好奇您如何看待這一點,如果這是預期的,以及這應該如何在業務中發揮作用?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • I think the sleep endoscopy increase in reimbursement was a nice surprise. We know that they have been working on that. When they initially came out at just $180, or what it was, was very disappointingly low for a 15-minute procedure, and it wasn't worth hospitals or ASCs to be able to do that procedure. But moving that up, I think it actually brought the economics from the actuals over the last couple of years kind of drove that calculation, and getting it to $1,600 really is going to be beneficial for the centers providing that DISE procedure. Then again, on the other hand, as we got discussed with our PREDICTOR study, we want to reduce the reliance on DISE anyways to be able to go to an office exam. We'd rather have the ENTs and the OR suites spend that time doing implant procedures rather than DISE. So very happy about the reimbursement there, and I'm sure all the centers and ASCs will be equally excited when that takes effect in November.

    我認為睡眠內窺鏡檢查報銷的增加是一個驚喜。我們知道他們一直在為此努力。當他們最初的價格僅為 180 美元時,對於一個 15 分鐘的手術來說,這個價格非常令人失望,而且醫院或 ASC 不值得去做這個手術。但如果把這個數字往上推,我認為它實際上帶來了過去幾年的實際經濟情況,這推動了這一計算,並且將其提高到 1,600 美元確實對提供 DISE 程序的中心有利。另一方面,正如我們在 PREDICTOR 研究中討論的那樣,我們希望無論如何都能減少對 DISE 的依賴,以便能夠參加辦公室考試。我們寧願讓耳鼻喉科和手術室花時間進行植入手術,而不是 DISE。我對那裡的報銷感到非常高興,我相信當 11 月份生效時,所有中心和 ASC 都會同樣興奮。

  • As far as the increase to the hospital and ASC payment for the Inspire procedure, that's tied to the overall APC, Ambulatory Procedure Code. And again, very happy with the continued increase, and that's been pretty steady of an increase year-over-year for the last several years. So again, it just continues to move north, and that's really good for the hospitals and ASCs. But we just have to address the Medicare ASC payments in the South.

    至於 Inspire 手術的醫院和 ASC 費用增加,這與整體 APC(流動手術規範)相關。再次,我對持續增長感到非常高興,而且過去幾年的同比增長相當穩定。再說一次,它繼續向北移動,這對醫院和 ASC 來說確實有好處。但我們只需要解決南方醫療保險 ASC 付款問題。

  • Travis Lee Steed - MD

    Travis Lee Steed - MD

  • And maybe you can talk about summer seasonality, kind of cadence of the year, Q3, Q4. Just any color on both the revenue and the margins and spending, that would be helpful.

    也許你可以談論夏季季節性、一年中的節奏、第三季度、第四季度。只要對收入、利潤和支出進行任何顏色標註,都會有所幫助。

  • Richard J. Buchholz - CFO

    Richard J. Buchholz - CFO

  • Travis, it's Rick. As we talked about, we're really proud of the achievement of the team in the first half of the year, and we talked about all the opportunities with some of the label changes and the change in the BMI warning and other catalysts. So we have increased our guidance to $600 million to $610 million. And so we talk about the step-up that, and I mentioned this in the prepared remarks, that we generally see a strengthening in our year in the fourth quarter, given the commercial mix with physicians and patients attempting to schedule those procedures before those high deductible plans reset at the beginning of the year. We will continue to increase our spending. We have shown leverage. We expect to improve that as we progress throughout the year. And so we're excited about the second half of the year, but there will be a strengthening in the fourth quarter.

    特拉維斯,我是瑞克。正如我們所談到的,我們對團隊上半年取得的成就感到非常自豪,我們談到了一些標籤變化以及 BMI 警告和其他催化劑變化帶來的所有機會。因此,我們將指導值提高至 6 億至 6.1 億美元。因此,我們討論了加強這一點,我在準備好的發言中提到了這一點,考慮到醫生和患者試圖在高水平之前安排這些程序的商業組合,我們通常會在第四季度看到今年的加強。年初重置的免賠額計劃。我們將繼續增加支出。我們已經展示了槓桿作用。我們希望隨著全年的進步而改善這一點。因此,我們對今年下半年感到興奮,但第四季度將會有所加強。

  • Operator

    Operator

  • And I show our next question comes from the line of Adam Maeder from Piper Sandler.

    我將展示我們的下一個問題來自 Piper Sandler 的 Adam Maeder。

  • Adam Carl Maeder - Director & Senior Research Analyst

    Adam Carl Maeder - Director & Senior Research Analyst

  • Congrats on the nice quarter. I wanted to ask about the OUS business, and apologies if this was asked earlier in the Q&A, but obviously, a big increase sequentially to $6 million. So the question is, is this kind of the new watermark? What drove the performance? And anything to call out from a competitive standpoint in Europe? And then I had a follow-up.

    祝賀這個美好的季度。我想詢問 OUS 業務的情況,如果之前在問答中問過這個問題,我深表歉意,但顯然,連續大幅增長至 600 萬美元。那麼問題來了,這就是新的水印嗎?是什麼推動了性能?從歐洲競爭的角度來看,有什麼值得指出的嗎?然後我進行了跟進。

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Sure. I think it really is down to the performance of the Inspire team, and the focus in Germany was really strong and drove most of that growth. I also want to compliment the team in the Netherlands with opening new centers in the Netherlands. That's something we haven't been able to do for several years. And also Switzerland and the rest of that market really did very, very strong. We haven't really seen the performance from Belgium yet. That's still forthcoming. You're going to see, with the implementation of the national insurance coverage in Belgium, they're going to have a strong second half, so that's going to continue to move north.

    當然。我認為這確實取決於 Inspire 團隊的表現,而且對德國的關注非常強烈,推動了大部分增長。我還想讚揚荷蘭團隊在荷蘭開設新中心。這是我們多年來一直無法做到的事情。瑞士和該市場的其他國家也確實表現得非常非常強勁。我們還沒有真正看到比利時隊的表現。這仍然是即將發生的事情。你會看到,隨著比利時國家保險的實施,他們將有一個強勁的下半年,因此將繼續向北移動。

  • I think the U.K. has done implants, but now we're able to open up additional centers in the U.K., which is really promising. And we previously announced that we were awarded countrywide reimbursement in France, but France is working through the coding set, the CPT coding equivalent in France, to make sure that when they lay this out publicly and puts us on the registry that it will have the CPT codes in place. We expect that to happen post-vacation time in Europe, and so that will do a full launch in the latter half of the year, which is really exciting for France, which is obviously one of the largest markets in Europe. So while we have good progress in Europe, I think the upside is still yet to come, and it's really driven by the introduction of reimbursement in those countries. And that's what's really going to continue to drive the business.

    我認為英國已經進行了植入,但現在我們能夠在英國開設更多中心,這確實很有希望。我們之前宣布,我們在法國獲得了全國范圍內的報銷,但法國正在研究編碼集(法國的CPT 編碼等效),以確保當他們公開公佈這一點並將我們放在註冊表中時,它將擁有CPT 代碼到位。我們預計這將在歐洲假期後發生,因此將在今年下半年全面推出,這對法國來說確實令人興奮,因為法國顯然是歐洲最大的市場之一。因此,儘管我們在歐洲取得了良好進展,但我認為上行空間尚未到來,而這實際上是由這些國家引入報銷制度推動的。這才是真正繼續推動業務發展的因素。

  • No comment on competition. I'm not sure that has any kind of impact on us over there. But the team is really moving very, very strong. And later in the year, I think you're going to start to see some progress over from Asia. As we mentioned, Singapore is doing really well. And Japan, we're just coming through the transition to a direct representation in that country, and you're going to start seeing activity in Japan, which is really our focus in the Asia markets.

    不評論競爭。我不確定這對我們那裡有什麼影響。但團隊確實非常非常強大。今年晚些時候,我認為您將開始看到亞洲取得的一些進展。正如我們提到的,新加坡做得非常好。在日本,我們剛剛過渡到在該國設立直接代表處,您將開始看到在日本的活動,這確實是我們在亞洲市場的重點。

  • Adam Carl Maeder - Director & Senior Research Analyst

    Adam Carl Maeder - Director & Senior Research Analyst

  • That's great color, Tim. And for the follow-up, I guess I'll ask about the digital scheduling tool. I'm curious if you can give an update in terms of the number of U.S. centers that are now on that tool right now. And just remind us of the difference in utilization between centers that have that and don't. And then a second part would be just on the ASC mix this quarter. Can you provide an update there?

    這顏色真棒,蒂姆。對於後續,我想我會詢問數字調度工具。我很好奇您是否可以提供目前使用該工具的美國中心數量的最新信息。只是提醒我們有和沒有的中心之間的利用率差異。然後第二部分將是本季度的 ASC 組合。你能在那裡提供更新嗎?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Absolutely. We're still in the pilot center of the digital scheduling, but probably about 60-plus centers are using the tool right now. And that's really exciting because it's good for the patients. They don't go through the poor experience of getting voicemail at a center when we're trying to make those appointments. So we're going to continue to push that. We're entering the second phase of that, where we can add additional centers, partnering with our software company to interface into their digital scheduling. So really that's what's happening there. I think some of the top centers, we're going to be pushing that obviously quicker with those centers with a higher utilization because that really just, again, streamlines that process going forward.

    絕對地。我們仍處於數字調度的試點中心,但目前可能有大約 60 多個中心正在使用該工具。這真的很令人興奮,因為這對患者有好處。當我們嘗試進行這些預約時,他們不會經歷在中心收到語音郵件的糟糕經歷。所以我們將繼續推動這一點。我們正在進入第二階段,我們可以添加更多中心,與我們的軟件公司合作以接入他們的數字調度。確實,這就是那裡正在發生的事情。我認為一些頂級中心,我們將明顯更快地推動那些利用率更高的中心,因為這確實再次簡化了未來的流程。

  • And the second question? ASC mix. I think that comes down to just a little bit higher Medicare mix in the second quarter, and Medicare tends to be dominated in the hospital setting, especially down South, where they have the reduced Medicare rates. But as we progress back to higher commercial rates as we progress through the quarter, I think that you'll see more and more progress with ASCs. But it really is our long-term vision that ASCs will be a key catalyst for driving the business, and we need to continue to provide education to ASCs when they negotiate their contracts with commercial payers to make sure that they have the carve-out for Inspire, and we need to work on the reimbursement levels from a Medicare standpoint and the proper mix between commercial and Medicare on ASCs.

    第二個問題呢? ASC 混合。我認為這可以歸結為第二季度醫療保險組合稍高一些,而醫療保險往往在醫院環境中占主導地位,尤其是在南方,那裡的醫療保險費率較低。但隨著本季度的進展,我們逐漸恢復到更高的商業利率,我認為您會看到 ASC 取得越來越多的進展。但我們的長期願景確實是,ASC 將成為推動業務發展的關鍵催化劑,當 ASC 與商業付款人談判合同時,我們需要繼續向他們提供教育,以確保他們能夠擺脫受到啟發,我們需要從醫療保險的角度來研究報銷水平,以及ASC 上商業保險和醫療保險之間的適當組合。

  • Operator

    Operator

  • And I show our next question comes from the line of Richard Newitter from Truist Securities.

    我將展示我們的下一個問題來自 Truist Securities 的 Richard Newitter。

  • Richard Samuel Newitter - Research Analyst

    Richard Samuel Newitter - Research Analyst

  • Nice job on another good quarter. Maybe my first question, I know in the past, you've talked about all these initiatives that you have to increase throughput efficiency. One of them is getting more physicians per implanting center. So do you have an update on kind of the percent of your centers or installed base that have more than one physician? And how should we think about that over the next few quarters?

    又一個好的季度做得很好。也許是我的第一個問題,我知道您過去已經談到了必須提高吞吐量效率的所有這些舉措。其中之一是每個植入中心配備更多的醫生。那麼,您是否有關於您的中心或安裝基地擁有超過一名醫生的百分比的最新信息?在接下來的幾個季度我們應該如何考慮這個問題?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Yes, absolutely. I don't have a specific number for you. We know that continues to grow. And that's a primary factor when reps go in to make sure we, number one, have a backup. Who is your backup? If the surgeon goes away or is unable to perform procedures, as just a routine measure, we want to always have a backup. The other thing is we always look at, a lot of our surgeons have multiple sites of service, so they can do procedures at a hospital, but they also have a backup at an ASC per se. A lot of surgeons have multiple hospitals and an ASC. So for the most part, we're getting to the point we have multiple surgeons in most facilities, but most surgeons also have multiple sites of service, so kind of counteracts itself from that standpoint.

    是的,一點沒錯。我沒有具體的號碼給你。我們知道這一數字還在持續增長。當銷售代表介入以確保我們第一有備份時,這是一個主要因素。誰是你的後盾?如果外科醫生離開或無法執行手術(這只是例行措施),我們希望始終有一個備份。另一件事是我們一直關注的,我們的很多外科醫生都有多個服務地點,因此他們可以在醫院進行手術,但他們本身在 ASC 也有後備人員。許多外科醫生擁有多家醫院和 ASC。因此,在大多數情況下,我們已經達到了這樣的程度:大多數機構都有多名外科醫生,但大多數外科醫生也有多個服務地點,因此從這個角度來看,這有點抵消了自身的優勢。

  • What we're really excited about both from ENT and sleep is we have a very active fellows program. We want to capture the surgeons as they graduate and go forward into their first job to make sure that they're bringing their Inspire experience with them. And what we're doing is very actively training them before they start their jobs to really focus on making sure Inspire is part of their practice as they get going.

    對於耳鼻喉科和睡眠科,我們真正感到興奮的是我們有一個非常活躍的研究員計劃。我們希望捕捉到外科醫生畢業並進入第一份工作時的情況,以確保他們將 Inspire 經驗帶入其中。我們正在做的是在他們開始工作之前非常積極地培訓他們,真正專注於確保 Inspire 成為他們開始工作時實踐的一部分。

  • And we're doing that, again, both in ENT and sleep. We just finished our annual fellows course, and we had quite a few ENTs -- I'm not sure the exact numbers on those -- of the ENTs that graduated this year, but we're looking at about a 50% conversion of those surgeons being able to do Inspire procedures in their first year, and that same thing goes forward with sleep physicians. So we're going to continue to expand that program going forward and get Inspire taught more at the medical school level.

    我們在耳鼻喉科和睡眠方面再次這樣做。我們剛剛完成年度研究員課程,今年畢業的 ENT 中有不少 ENT(我不確定具體數字),但我們正在考慮這些人的轉化率約為 50%外科醫生在第一年就能進行Inspire 手術,睡眠醫生也能做同樣的事情。因此,我們將繼續擴大該計劃,並在醫學院層面更多地教授 Inspire。

  • Richard Samuel Newitter - Research Analyst

    Richard Samuel Newitter - Research Analyst

  • And then kind of a generic question with respect to the utilization backdrop for a number of elective procedures out there. It's been strong in the first half, above trend. I know you guys are in a different situation, so underpenetrated into this huge TAM. But I'm curious to the extent to which you're seeing any kind of backlog or pent-up demand that's continuing to come in and support strong results? And if you are, what the outlook is from a contribution standpoint as we move into the back half?

    然後是關於一些選擇性手術的使用背景的一般性問題。上半年表現強勁,高於趨勢。我知道你們處於不同的情況,所以對這個巨大的 TAM 的滲透不夠。但我很好奇,您在多大程度上看到積壓或被壓抑的需求持續出現並支持強勁的業績?如果是的話,當我們進入後半部分時,從貢獻的角度來看,前景如何?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Yes, we are. I think we're seeing continued growth across all of our centers. Obviously, same-store sales drove the growth in Q2, as it did in Q1, and I think will continue to do so as we move forward. I think that we're excited, again, about the pop that we saw with Medicare in the second quarter. And I think that kind of overwhelmed a little bit more of the commercial cases, which will come on strong in the second half. So the demand continues to be there. As you mentioned, Rich, we continue to be underpenetrated in the TAM.

    是的我們是。我認為我們所有的中心都在持續增長。顯然,同店銷售推動了第二季度的增長,就像第一季度一樣,我認為隨著我們的前進,這種情況將繼續下去。我認為我們再次對第二季度醫療保險的流行感到興奮。我認為這有點壓倒了更多的商業案例,這些案例將在下半年表現強勁。所以需求仍然存在。正如您所提到的,Rich,我們在 TAM 中的滲透率仍然較低。

  • And we still have limitations on the number of surgeons performing the procedures. So we still need to continue to address that and work the backlog of patients. But absolutely, people want to have their obstructive sleep apnea taken care of. Demand from our direct-to-consumer continues to be very effective. Our contacts are high. Our efficiency and conversions of patients through implant continues to be strong. We just got to continue to open up more OR time by training and getting ENTs to commit more of their time to these patients.

    我們對執行手術的外科醫生數量仍然有限制。因此,我們仍然需要繼續解決這個問題並解決積壓的患者問題。但毫無疑問,人們希望阻塞性睡眠呼吸暫停得到治療。我們直接面向消費者的需求仍然非常有效。我們的聯繫度很高。我們通過植入的效率和患者轉化率仍然很高。我們只需通過培訓繼續騰出更多手術室時間,並讓耳鼻喉科人員將更多時間投入到這些患者身上。

  • Operator

    Operator

  • And I show our next question comes from the line of Larry Biegelsen from Wells Fargo.

    我將展示我們的下一個問題來自富國銀行的拉里·比格爾森 (Larry Biegelsen)。

  • Lei Huang - Associate Analyst

    Lei Huang - Associate Analyst

  • It's Lei calling in for Larry. Congratulations on the quarter. Just on the guidance, you raised the full year revenue guidance by a little more than the beat. That seems implied in the second half, your top line growth is closer to 30%, whereas you grew over 70% in the first half. So if you can just talk about why the deceleration? Is there something other than conservatism and just general confidence in the second half outlook? And I have a follow-up.

    是雷打來拉里的電話。祝賀本季度。就指導而言,您將全年收入指導提高了一點。這似乎暗示下半年,你的收入增長接近 30%,而上半年你的增長超過 70%。那麼您能否談談為什麼減速?除了保守主義和對下半年前景的普遍信心之外,還有其他什麼嗎?我有一個後續行動。

  • Richard J. Buchholz - CFO

    Richard J. Buchholz - CFO

  • Lei, it's Rick. We haven't changed our guidance strategy. And so we put forth guidance that we believe in and we can stand behind. We did talk about the mix of Medicare and commercial. And so with that said, we expect a real strengthening of the commercial procedures as we enter into the fourth quarter. Despite that, we're very proud of the Inspire team in the first half of the year, and we have increased guidance, so really similar to previous years on how our revenue will kind of roll out for the year.

    雷,我是瑞克。我們沒有改變指導策略。因此,我們提出了我們相信並支持的指導方針。我們確實討論了醫療保險和商業的結合。話雖如此,我們預計隨著進入第四季度,商業程序將得到真正加強。儘管如此,我們對今年上半年的 Inspire 團隊感到非常自豪,並且我們增加了指導,因此與前幾年非常相似,我們今年的收入將如何推出。

  • Lei Huang - Associate Analyst

    Lei Huang - Associate Analyst

  • Got it. Okay. And then just my second question, Tim, you talked about the new Head of Strategy that you just hired, what will be his focus? The company has close to $500 million in cash. Should we read that as perhaps an increased interest in expanding your portfolio, either inside sleep apnea or even outside of sleep apnea?

    知道了。好的。然後是我的第二個問題,蒂姆,您談到了您剛剛聘請的新戰略主管,他的重點是什麼?該公司擁有近5億美元現金。我們是否應該將其視為擴大您的投資組合的興趣增加,無論是在睡眠呼吸暫停內部還是在睡眠呼吸暫停之外?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Sure. Great question. Carlton is a great talent. And as we continue to grow, we need that leadership to be able to scale our business. And I definitely see where you're coming from that. Our investments in the past were focused on technical tools that can help us grow the adoption of Inspire. That's not changing. I think we're going to focus on building the Inspire business to treat obstructive sleep apnea, nothing has changed there. And yes, we've been successful at making sure we have a strong balance sheet.

    當然。很好的問題。卡爾頓是一個偉大的人才。隨著我們的不斷發展,我們需要這種領導力來擴大我們的業務。我絕對明白你的出發點。我們過去的投資主要集中在可以幫助我們提高 Inspire 普及率的技術工具上。這並沒有改變。我認為我們將專注於建立 Inspire 業務來治療阻塞性睡眠呼吸暫停,這方面沒有任何改變。是的,我們已經成功地確保了我們擁有強大的資產負債表。

  • But our focus today remains with obstructive sleep apnea and leveraging tools as we have with Ognomy and EnsoData to be able to help patients make appointments with physicians to integrate in with the SleepSync(TM) system. But again, we're keeping our focus. We're growing the adoption of Inspire, and Carlton is going to be just instrumental in helping us with our overall strategy plan and understanding what this organization looks like when we go to $1 billion, $2 billion in annual revenue and what does the organization need to look like, not only from our external team but from our operational side, our clinical evaluation, our quality and our overall company as a whole.

    但我們今天的重點仍然是阻塞性睡眠呼吸暫停,並利用 Ognomy 和 EnsoData 等工具幫助患者與醫生預約,以便與 SleepSync(TM) 系統集成。但我們還是要保持專注。我們正在越來越多地採用Inspire,而Carlton 將在幫助我們制定總體戰略計劃方面發揮重要作用,並幫助我們了解當我們的年收入達到10 億美元、20 億美元時該組織會是什麼樣子以及該組織需要什麼不僅從我們的外部團隊來看,而且從我們的運營方面、我們的臨床評估、我們的質量以及我們整個公司來看。

  • Operator

    Operator

  • And I show our next question comes from the line of Anthony Petrone from Mizuho Americas.

    我表明我們的下一個問題來自 Mizuho Americas 的 Anthony Petrone。

  • Anthony Charles Petrone - MD & Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst

    Anthony Charles Petrone - MD & Senior Medical Devices, Diagnostics and Therapeutics Equity Research Analyst

  • Congrats on another strong quarter here. Maybe a quick one just on Inspire V, just to sort of clarify the pricing strategy for the latest gen system as we look toward a rollout, how will it stack up against the existing systems out there. And then a quick follow-up would be, when we look at the 2 themes of GLP-1s potentially lowering BMI for even patients now contraindicated above 40 BMI, but with that label expansion up to 40 BMI, when you think of those 2 out there now concurrently, how many patients can that actually bring into the category where they would be eligible for hypoglossal nerve stimulation?

    祝賀又一個強勁的季度。也許只是關於 Inspire V 的快速介紹,只是為了在我們期待推出時澄清最新一代系統的定價策略,以及它將如何與現有系統相比較。然後快速跟進是,當我們研究 GLP-1 的 2 個主題時,即使現在 BMI 超過 40 的患者也可能降低 BMI,但隨著標籤擴展至 40 BMI,當你想到這 2 個主題時現在,有多少患者實際上可以進入有資格接受舌下神經刺激的類別?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Got it. As far as Inspire V, we're still evaluating that and what our pricing strategy will be when we launch. It will be a change because, again, we won't be selling the pressure sensing lead either. So a little bit of time yet to come on that. We're still doing ongoing evaluation. As we've always said in the past, we tend to do price increases with technology improvements, and this is certainly a strong technology improvement, not only with Inspire V, but it opens up platform, allowing us to go to VI and VII and beyond. So a lot more to come on that, and we'll report back in the future.

    知道了。就 Inspire V 而言,我們仍在評估這一點以及我們推出時的定價策略。這將是一個改變,因為我們也不會出售壓力傳感引線。所以還有一點時間。我們仍在進行持續評估。正如我們過去常說的,我們傾向於通過技術改進來提高價格,這當然是一個強大的技術改進,不僅是Inspire V,而且它開放了平台,使我們能夠進入VI和VII,超過。所以還有很多事情要做,我們將在未來報告。

  • As far as GLP-1, you put out a note yesterday. You did a call with a doctor. That was very intriguing in regards to their take on what GLP-1 is going to do with addressing Inspire and how it's going do with overall weight loss is a very interesting discussion. I think what we're seeing is, we know that when you get a BMI above about 35, we can screen out well over a third of the patients due to complete concentric collapse or lateral wall collapses associated with the larger neck circumference. As we go to a BMI of 37, even up to 40, that's when you're going to screen of 50% or higher.

    至於GLP-1,您昨天發布了一份說明。你給醫生打了電話。他們對 GLP-1 將如何解決 Inspire 問題以及它將如何實現整體減肥的看法非常有趣,這是一個非常有趣的討論。我認為我們所看到的是,我們知道,當您的BMI 高於35 左右時,我們可以篩選出超過三分之一的患者,因為這些患者是由於與較大頸圍相關的完全同心塌陷或側壁塌陷。當我們的 BMI 達到 37,甚至達到 40 時,您的篩查率就會達到 50% 或更高。

  • And so if you can just look at the number of patients up there, when we're able to help them with the GLP-1 to be able to lose weight and relax the lateral wall component of their obstructive sleep apnea, that's going to have a significant impact on the Inspire business. The key is going to be, it will take time. I think your report highlighted that there's not a lot of activity that you've seen to date yet. We haven't heard a lot subjectively from the field on progress made with GLP-1, but we do know that's coming in the future.

    因此,如果您只看一下那裡的患者數量,當我們能夠通過 GLP-1 幫助他們減肥並放鬆阻塞性睡眠呼吸暫停的側壁部分時,就會有對 Inspire 業務產生重大影響。關鍵是,這需要時間。我認為您的報告強調了迄今為止您還沒有看到太多活動。我們還沒有從該領域主觀地聽到太多關於 GLP-1 取得的進展,但我們確實知道這將在未來發生。

  • Operator

    Operator

  • And I show our next question comes from the line of David Rescott from Baird.

    我表明我們的下一個問題來自貝爾德 (Baird) 的大衛·雷斯科特 (David Rescott)。

  • David Kenneth Rescott - Senior Research Analyst

    David Kenneth Rescott - Senior Research Analyst

  • Congrats on the strong quarter here. Just first on utilization in the U.S. I'm wondering maybe what's driving that, not what's driving that, but when we think about kind of the bell curve of physicians that may be or centers or maybe toward the upper end, middle end and lower end of this range, is increasing utilization kind of coming from any one of those specific segments? Or is it more or less broad across the kind of spectrum of centers? And then when we think about maybe those toward the higher end of that range, are there still improvements in utilization coming from those centers? Or are they approaching maybe somewhat of a capping out kind of level?

    祝賀本季度的強勁表現。首先關於美國的利用率,我想知道是什麼推動了這一點,而不是是什麼推動了這一點,但是當我們考慮醫生的鐘形曲線時,它可能是或集中或可能朝向上端、中端和下端在這個範圍內,利用率的提高是否來自於這些特定細分市場中的任何一個?或者它在各種中心範圍內或多或少是廣泛的?然後,當我們考慮那些接近該範圍高端的中心時,這些中心的利用率是否仍有改善?或者他們是否正在接近某種上限水平?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Yes, thanks for the question. I think we still have quite a ways to go as far as utilization. We can talk about the characteristics of the higher-end sites, and the key characteristic is team. And what that means is the surgeons can focus on those aspects of their practice and they can rely on sleep physicians who will do a lot of the longitudinal management of the patients, a lot of the programming of the device. And so the highest utilization centers have multiple surgeons and they have a well-defined team to know who does what with the patient, and it's easy for the patients to see their process through from the initial screening through the implant, through the longitudinal patient management.

    是的,謝謝你的提問。我認為在利用率方面我們還有很長的路要走。我們可以講一下高端網站的特點,最關鍵的特點就是團隊。這意味著外科醫生可以專注於他們實踐的這些方面,他們可以依靠睡眠醫生,他們將對患者進行大量的縱向管理,並對設備進行大量的編程。因此,利用率最高的中心擁有多名外科醫生,他們有一個明確的團隊,知道誰對病人做了什麼,病人很容易看到他們的過程,從最初的篩查到植入,再到縱向的病人管理。

  • I think that's kind of the key that we try to educate the tier 2 and the tier 3 sites with is you've got to be able to have a team. We have great respect for our friends who are those ENT surgeons who have dual board certified in sleep medicine because those are the early adopters. They've been with us since the very beginning. But they need to transition a little bit to have partnership with sleep physicians and other surgeons to really help them build their capacity. And what's important here is we know centers with the highest capacities also have the highest patient outcomes. Well, that's natural because everybody at the facility knows their job. Everybody at the facility is experienced, and they know what a good patient outcome is. And so we keep pushing utilization. And I think you highlighted that in your initiation report on that as well. So I think that's really kind of a key is we're going to keep pushing utilization as we move forward.

    我認為這就是我們試圖教育二級和三級網站的關鍵,那就是你必須能夠擁有一個團隊。我們非常尊重我們的朋友,他們是那些擁有睡眠醫學雙委員會認證的耳鼻喉科醫生,因為他們是早期採用者。他們從一開始就和我們在一起。但他們需要進行一些轉變,與睡眠醫生和其他外科醫生建立合作夥伴關係,以真正幫助他們增強能力。這裡重要的是我們知道能力最高的中心也有最高的患者治療效果。嗯,這很自然,因為工廠裡的每個人都知道自己的工作。該機構的每個人都經驗豐富,他們知道什麼是良好的患者治療效果。因此,我們不斷提高利用率。我認為您在啟動報告中也強調了這一點。所以我認為這確實是一個關鍵,我們將在前進的過程中繼續提高利用率。

  • David Kenneth Rescott - Senior Research Analyst

    David Kenneth Rescott - Senior Research Analyst

  • Just second one from us on the expanded AHI, BMI labels. I know you guys provided some comments around the impact there. But I'm just thinking or wondering, I guess, more towards the top of the funnel, I guess, to the extent of which you're able to see, if maybe you've heard anything anecdotal just around physicians more or less at the margin maybe considering offering the therapy to a broader number of patients, given that those labels have been bumped up a little bit?

    這是我們在擴展 AHI、BMI 標籤上的第二個。我知道你們就那裡的影響提供了一些評論。但我只是在思考或想知道,我想,更多的是接近漏斗的頂部,我想,在你能夠看到的範圍內,如果你或多或少聽到過關於醫生的任何軼事,考慮到這些標籤已經被提高了一點,利潤可能會考慮向更多的患者提供這種療法?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • High AHI, absolutely. We made sure all the physicians knew about the high AHI approval right away. We're working with the commercial payers on an update to their policies on that, amongst other things, including the pediatric population as well. The key is going to be that. That's important because those patients just don't have many other options. As far as the high BMI, as we've been talking about with the GLP-1, we're being very careful about jumping too fast into the high BMI ring because those patients will have a higher probability of being screened out with the DISE procedure because the complete concentric collapse or the lateral wall collapse. And those are the concerns, those are the patients we think can benefit from the GLP-1 drugs. So we're being very careful about BMI, pushing really hard on high AHI, pushing very hard on pediatrics with Down syndrome, and then we'll talk more in the near future about transition of DISE to that whole PREDICTOR. That will also be a key component with payers.

    絕對是高 AHI。我們確保所有醫生立即了解 AHI 的高度認可。我們正在與商業付款人合作更新他們的政策,其中包括兒科人群。關鍵就在於此。這很重要,因為這些患者沒有太多其他選擇。就高 BMI 而言,正如我們一直在討論 GLP-1 一樣,我們非常小心不要太快地跳入高 BMI 環,因為這些患者將有更高的概率被 DISE 篩查出來手術過程中由於完全同心塌陷或側壁塌陷。這些就是我們所關心的問題,這些是我們認為可以從 GLP-1 藥物中受益的患者。因此,我們對 BMI 非常謹慎,非常努力地推動高 AHI,非常努力地推動患有唐氏綜合症的兒科,然後我們將在不久的將來更多地討論 DISE 向整個 PREDICTOR 的過渡。這也將是付款人的一個關鍵組成部分。

  • Operator

    Operator

  • And I show our next question comes from the line of Matthew Mishan from KeyBanc.

    我將展示我們的下一個問題來自 KeyBanc 的 Matthew Mishan。

  • Matthew Ian Mishan - VP & Senior Equity Research Analyst

    Matthew Ian Mishan - VP & Senior Equity Research Analyst

  • I wanted to talk a little bit about SleepSync(TM), and how many of these new centers that you're adding are also kind of adopting SleepSync(TM)? And then kind of where are they in like the pathway -- and where are some of the larger centers in the pathway towards reimbursement for remote patient monitoring?

    我想談談 SleepSync(TM),以及您添加的這些新中心中有多少也採用了 SleepSync(TM)?那麼它們在哪裡,就像路徑一樣——一些較大的中心在遠程患者監測報銷的路徑中又在哪裡?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Great question. The Bluetooth remote that was launched last year really is the big change to SleepSync(TM). It provided the utility of the system to directly interface the patient's device with SleepSync(TM) so the physicians and the healthcare providers can now have a real-time view of how those patients are doing. When we open new centers, as we have for the last several quarters, new centers being trained are automatically put on SleepSync(TM). And our process is going back to the older centers that have been out for a while and starting to train them to add SleepSync(TM) to their process. But as far as new centers goes, it's standard requirement right upfront.

    很好的問題。去年推出的藍牙遙控器確實是對 SleepSync(TM) 的重大改變。它提供了系統實用程序,可將患者的設備與 SleepSync(TM) 直接連接,因此醫生和醫療保健提供者現在可以實時查看患者的情況。當我們開設新中心時,就像過去幾個季度一樣,正在接受培訓的新中心會自動啟用 SleepSync(TM)。我們的流程是回到已經退出一段時間的老中心,並開始培訓他們將 SleepSync(TM) 添加到他們的流程中。但就新中心而言,這是預先的標準要求。

  • We train all of them to make sure they're a part of it. It's necessary to have this direct communication. And as we mentioned, we already have the new physician programmer approved, and we're going to launch that in the beginning of next year. All the actions taken with the physician programmer are automatically stored in SleepSync(TM). And all the information from the patient remote from the implanted product is transitioned via the patient's smartphone to SleepSync(TM). And we're going to be introducing tools such as the sensor that goes under patients' mattresses to be able to record and monitor a patient's quality of sleep that will be part of SleepSync(TM).

    我們對所有人進行培訓,以確保他們成為其中的一部分。這種直接的溝通是必要的。正如我們提到的,我們已經批准了新的醫師程序員,我們將在明年初啟動它。醫生程序員採取的所有操作都會自動存儲在 SleepSync(TM) 中。遠離植入產品的患者的所有信息均通過患者的智能手機傳輸至 SleepSync(TM)。我們將推出一些工具,例如放置在患者床墊下的傳感器,能夠記錄和監測患者的睡眠質量,這將成為 SleepSync(TM) 的一部分。

  • We are interfacing with our minority investments, Ognomy and EnsoData, so their data automatically uploads to SleepSync(TM). And what SleepSync(TM) is going to be, it's going to be all-encompassing patient management tool that's going to have not only the objective evidence for the quality of sleep, but they'll also be able to input the subjective data from the patient, how do they feel when they do a telemedicine, right? What kind of complaints do they have? Is everything working fine with them?

    我們正在與我們的少數投資、Ognomy 和 EnsoData 連接,因此他們的數據會自動上傳到 SleepSync(TM)。 SleepSync(TM) 將會是一個包羅萬象的患者管理工具,不僅有睡眠質量的客觀證據,而且還能夠輸入來自睡眠質量的主觀數據。患者,當他們進行遠程醫療時,他們的感受如何,對吧?他們有什麼樣的抱怨?他們一切順利嗎?

  • And then the next step after this with SleepSync(TM) is we're going to be able to start taking action from a physician's office to a patient's home with remote patient programming. That's going to be tremendous. We're already working on that in-house. We're already in communication with FDA as well on that. So that's going to be a key step going forward.

    借助 SleepSync(TM),下一步我們將能夠通過遠程患者編程從醫生辦公室到患者家中採取行動。這將是巨大的。我們已經在內部開展這方面的工作。我們也已經就此與 FDA 進行了溝通。因此,這將是前進的關鍵一步。

  • Matthew Ian Mishan - VP & Senior Equity Research Analyst

    Matthew Ian Mishan - VP & Senior Equity Research Analyst

  • I'd just ask one last one on all these new centers that you're adding. Is this really a push from your sales force? Or is it a pull from these centers basically asking or saying we need to add this to our practice?

    我只想問最後一個關於您添加的所有這些新中心的問題。這真的是您的銷售人員的推動嗎?或者是這些中心的拉動,基本上要求或說我們需要將其添加到我們的實踐中?

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • Where we are today, we're still a pull. When we do our direct-to-consumer, yes, we are creating a brand, and a lot of patients see that as they come to our website. Well, physicians see this as well. We haven't mentioned this at all today, but we get general practitioners, family practice doctors, they see those outreach programs as well. They come to our website saying, "Look, my patient is going to ask me about this, I need to know how to communicate with my patient." So we have a large educational process with general practitioners or family practice doctors on how to talk to their patients and how to refer their patients to the ENTs.

    我們今天所處的位置,仍然具有吸引力。當我們直接面向消費者時,是的,我們正在創建一個品牌,很多患者在訪問我們的網站時都會看到這一點。嗯,醫生也看到了這一點。我們今天根本沒有提到這一點,但我們有全科醫生、家庭醫生,他們也看到了這些外展計劃。他們來到我們的網站說:“看,我的病人會問我這個問題,我需要知道如何與我的病人溝通。”因此,我們對全科醫生或家庭醫生進行了大規模的教育,告訴他們如何與患者交談以及如何將患者轉診至耳鼻喉科。

  • And so today, we're still responding to outside demand that we need to have this in our practice. And the first thing we do when we get an inbound call from a center is we kind of make them fill out an application. I know that sounds arrogant, but it's not. What it is? It's an organizational form that helps them identify who is who in the zoo? Who is the ENT? Who is the sleep physician? Do you have support from the C-suite? Do we have a proper navigator? Do we have the OR team? Who's going to do sleep endoscopy? How are you tied into your sleep practices? So we really kind of coordinate all the key functions that are necessary for centers to come onboard with a high utilization. So we're still in that early stage where we're bringing on patients, and we just don't have capacity in the centers yet. So we need to continue to grow the number of centers that we're training.

    因此,今天,我們仍在響應外部需求,即我們需要在實踐中實現這一點。當我們接到中心打來的電話時,我們要做的第一件事就是讓他們填寫一份申請表。我知道這聽起來很傲慢,但事實並非如此。這是什麼?這是一種幫助他們識別動物園裡誰是誰的組織形式?耳鼻喉科是誰?睡眠醫生是誰?您得到最高管理層的支持嗎?我們有合適的導航器嗎?我們有手術室團隊嗎?誰來做睡眠內窺鏡檢查?您如何與睡眠習慣聯繫起來?因此,我們確實協調了中心實現高利用率所需的所有關鍵功能。因此,我們仍處於接收患者的早期階段,而且我們的中心還沒有能力。因此,我們需要繼續增加我們正在培訓的中心數量。

  • Operator

    Operator

  • And I show our last question comes from the line of Suraj Kalia from Oppenheimer & Co.

    我表明我們的最後一個問題來自 Oppenheimer & Co. 的 Suraj Kalia。

  • Suraj Kalia - MD & Senior Analyst

    Suraj Kalia - MD & Senior Analyst

  • Congrats on the quarter. So Tim, I'll throw in all my questions quickly, all of them directed to you. So Tim, on your comments on GLP-1s, I appreciate the color. Maybe you can walk us through -- I look upon this as a 2-tailed curve, right? You were talking about high BMI getting pulled in and your comments about lateral collapse, I appreciate that. How do you look upon the net change? Because patients that are 30 to 35, 37, they're going to drop also. So I'm curious how do you all stratify what is the influx minus the outflux? So that's one question.

    恭喜本季度。蒂姆,我會很快提出我所有的問題,所有問題都直接向你提出。 Tim,關於您對 GLP-1 的評論,我很欣賞這種顏色。也許你可以引導我們完成——我將其視為一條 2 尾曲線,對嗎?你正在談論高體重指數被拉扯以及你對橫向塌陷的評論,我對此表示讚賞。您如何看待淨變化?因為 30 歲到 35 歲、37 歲的患者,他們的病情也會下降。所以我很好奇你們如何對流入量減去流出量進行分層?這是一個問題。

  • The second question, Tim, would be what percent of your patients currently are getting hypoglossal nerve stim but haven't even tried a CPAP?

    第二個問題,蒂姆,目前正在接受舌下神經刺激但甚至沒有嘗試過 CPAP 的患者中有多少百分比?

  • And the remote programming component, can you give us a specific example where remote programming has been done, whether it's neuromodulation, anything? And the reason I ask is general otolaryngologists, at least, and you and I have talked about this in the past also offline, they are sort of disconnected with the programming component of it they handed off. So I'm curious if you could, in the remaining time, just walk me through. Sorry, I threw all of those, and answers to any questions would be great.

    至於遠程編程部分,你能給我們一個具體的例子,其中遠程編程已經完成,無論是神經調節還是其他什麼?我問的原因至少是一般耳鼻喉科醫生,你和我過去也在線下討論過這個問題,他們與他們交付的編程組件有點脫節。所以我很好奇你能否在剩下的時間裡引導我完成這個過程。抱歉,我把所有這些都扔掉了,任何問題的答案都會很棒。

  • Timothy P. Herbert - CEO, President & Director

    Timothy P. Herbert - CEO, President & Director

  • No, those are all really, really good. Okay, BMI influx-outflux, you have knowledge on this, and that's why it's so key to talk about this. It's a percent of patients with a high BMI that actually have a lateral wall collapse. And as you highlight, not everybody does. And a lot of patients with the BMI of 37 only have tongue-based collapse, and so they will pass a sleep endoscopy and go right on to Inspire. The challenge that you're highlighting is how many patients do you have to see that will actually pass a DISE to be able to move on to Inspire and how much capacity did you eat up in that ENT's practice with patients that aren't able to get Inspire?

    不,這些都非常非常好。好的,BMI 流入-流出,你對此有所了解,這就是為什麼談論這個如此重要。 BMI 高的患者中,有一定比例的患者實際上患有側壁塌陷。正如您所強調的那樣,並不是每個人都這樣做。很多BMI為37的患者只有舌根塌陷,所以他們會通過睡眠內窺鏡檢查,然後繼續Inspire。您強調的挑戰是,您必須看診多少患者才能真正通過 DISE 才能繼續進行 Inspire,以及您在 ENT 的實踐中為無法通過 DISE 的患者消耗了多少能力得到啟發?

  • So it's a very good question. That's why we're being very careful with the high BMI. The good news is with PREDICTOR that airway exam, we can do a soft review in an office setting to see if a patient is likely to have a lateral wall collapse, and we're already in the next 300, so a lot more to come on that to really start stratifying those groups. But I think the GLP-1s are going to take those patients with the lateral wall collapse to the complete concentric collapse. And ideally, now we need to see how this works on practice. Ideally, lower their BMI and have them present really ideally as only a tongue-based collapse. So we need to track that going forward.

    所以這是一個非常好的問題。這就是為什麼我們對高 BMI 非常小心。好消息是,使用 PREDICTOR 進行氣道檢查,我們可以在辦公室環境中進行軟檢查,看看患者是否可能出現側壁塌陷,我們已經進入了接下來的 300 次檢查,所以還會有更多檢查在此基礎上真正開始對這些群體進行分層。但我認為 GLP-1 將使那些側壁塌陷的患者達到完全同心塌陷。理想情況下,現在我們需要看看這在實踐中是如何運作的。理想情況下,降低他們的體重指數,讓他們真正理想地表現為僅舌頭崩潰。所以我們需要繼續跟踪這一情況。

  • Your second question was with what percent of our hypoglossal nerve stimulation patients have actually tried CPAP? And the reference to this is with the Philips recall, did we get a significant amount of patients that were able to bypass CPAP and go right to Inspire? I think the real answer to that is probably not. I think the great majority of our patients have all tried CPAP. And I think that is a gate that the insurance companies always ask. I am sure there's a small percent that have been able to go through because they're unable to get a CPAP machine because there wasn't inventory there from ResMed. There wasn't inventory, obviously, from Philips because of the recall. But I think, historically, I think very few of our patients actually get through bypassing CPAP. So I think probably it really has no impact on the inventory side.

    您的第二個問題是,我們的舌下神經刺激患者中有多少百分比真正嘗試過 CPAP?與此相關的是飛利浦的召回事件,我們是否有大量患者能夠繞過 CPAP 並直接使用 Inspire?我認為真正的答案可能不是。我想我們絕大多數的患者都嘗試過CPAP呼吸機。我認為這是保險公司經常詢問的一個問題。我確信有一小部分人能夠通過,因為他們無法獲得 CPAP 機器,因為那裡沒有 ResMed 的庫存。顯然,由於此次召回,飛利浦沒有庫存。但我認為,從歷史上看,我們的患者中很少有人真正能夠繞過 CPAP 治療。所以我認為這可能對庫存方面確實沒有影響。

  • Neuromod, I think Abbott has approval for some of the diabetes products. And so if you look at the way SleepSync(TM) is set up and we look at the screens of SleepSync(TM), they really are modeled after our good friends at ResMed. And ResMed did a really good job with the Brightree system having a patient management system that the sleep physicians know how to manage their patients. And if we could model our screens after those, the sleep physicians would be comfortable using SleepSync(TM), and that's kind of the tool we're using. And those are the sleep physicians, those are the ones that manage the patients longitudinally, and those are the ones that the remote program is designed for. Now you may have ENTs that are doing more certified sleep, and they do the longitudinal management. But we're really kind of building SleepSync(TM) for the longitudinal management and remote programming. And FDA has approved that for implanted products in the past. So we do have precedents for which to move forward with. So thank you very, very much on that, Suraj.

    Neuromod,我認為雅培已經批准了一些糖尿病產品。因此,如果您看看 SleepSync(TM) 的設置方式以及我們查看 SleepSync(TM) 的屏幕,就會發現它們確實是按照我們在 ResMed 的好朋友的模型製作的。 ResMed 在 Brightree 系統上做得非常好,它擁有一個患者管理系統,睡眠醫生知道如何管理患者。如果我們能夠按照這些模型對屏幕進行建模,那麼睡眠醫生就會輕鬆地使用 SleepSync(TM),而這正是我們正在使用的工具。這些是睡眠醫生,那些是縱向管理患者的醫生,那些是遠程程序的設計對象。現在,耳鼻喉科可能會進行更多認證睡眠,並且進行縱向管理。但我們實際上是在構建 SleepSync(TM) 用於縱向管理和遠程編程。 FDA 過去已批准將其用於植入產品。因此,我們確實有可以繼續前進的先例。非常非常感謝你,Suraj。

  • I know we're over time, but I just want to make one last note. I want to thank you all 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 Inspire 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 teams for their continued efforts as we remain focused on further expanding our business in the U.S., Europe and in Asia. And for all of you on the call, we appreciate your continued interest in and support of Inspire and look forward to providing you with further updates in the months ahead. Please stay safe and healthy. Thank you very much.

    我知道我們已經超時了,但我只想做最後一點說明。我要感謝大家今天加入電話會議。一如既往,我感謝不斷壯大的 Inspire 員工團隊的熱情、辛勤工作和持續動力,以實現成功和一致的患者治療結果。 Inspire 團隊對患者的承諾是無與倫比的,也是我們成功的最重要因素。我要感謝我們所有的員工以及醫療保健團隊在我們繼續專注於進一步擴大我們在美國、歐洲和亞洲的業務的同時所做出的持續努力。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,並期待在未來幾個月為您提供進一步的更新。請保持安全和健康。非常感謝。

  • Operator

    Operator

  • This concludes today's conference call. You may now disconnect.

    今天的電話會議到此結束。您現在可以斷開連接。