Inspire Medical Systems Inc (INSP) 2025 Q1 法說會逐字稿

Good afternoon. My name is Dilem, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Inspire Medical Systems First Quarter 2025 Conference Call. (Operator Instructions). Please be advised that today's conference is being recorded.

午安.我叫 Dilem，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Inspire Medical Systems 2025 年第一季電話會議。（操作員指令）。請注意，今天的會議正在錄音。

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

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

Thank you, Dilem, and thank you all for participating in today's call. Joining me are Tim Herbert, Chairman and Chief Executive Officer; and Richard Buchholz, Chief Financial Officer. Earlier today, we released financial results for the three months ended March 31, 2025. The a copy of the press release is available on our website. On this call, management will make forward-looking statements within the meaning of the federal securities laws.

謝謝你，Dilem，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首席執行官蒂姆·赫伯特 (Tim Herbert) 和首席財務官理查德·布赫霍爾茨 (Richard Buchholz)。今天早些時候，我們發布了截至 2025 年 3 月 31 日的三個月的財務業績。新聞稿的副本可在我們的網站上查閱。在本次電話會議上，管理階層將根據聯邦證券法做出前瞻性陳述。

All forward-looking statements, including without limitation, those relating to our operations, financial results and financial condition, investments in our business, full year 2025 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.

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、2025 年全年財務和營運前景以及市場准入變化有關的陳述，均基於我們當前的估計和各種假設。這些聲明涉及重大風險和不確定性，可能導致實際結果或事件產生重大差異。

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. 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.

因此，您不應過度依賴這些聲明。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美國證券交易委員會提交的 10-Q 表，以了解這些風險和不確定性的描述。除法律要求外，Inspire 不承擔更新或修改任何財務預測或前瞻性聲明的任何意圖或義務，無論是由於新資訊、未來事件或其他原因。

This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 5, 2025.

本次電話會議包含時間敏感訊息，僅代表截至今天（2025 年 5 月 5 日）現場直播時的觀點。

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

說完這些，我很高興將電話轉給提姆·赫伯特。提姆？

Thank you, Ezgi, and thanks, everyone, for joining our business update call for the first quarter of 2025. We achieved many important milestones to start the year as our patients remain our top focus, we are proud to announce that since the inception of Inspire, we have surpassed 100,000 patients who have received Inspire therapy.

謝謝 Ezgi，也謝謝大家參加我們 2025 年第一季的業務更新電話會議。我們在年初取得了許多重要的里程碑，因為我們的患者仍然是我們的首要關注點，我們很自豪地宣布，自 Inspire 成立以來，接受過 Inspire 治療的患者已超過 100,000 名。

Even with this key milestone, there is so much more in front of us as we remain lightly penetrated in our target market, and we are just getting started. We also recently announced the appointment of Dr. Paul Hoff and Dr. Rahir Patel as Vice President and Senior Medical Directors. Dr. Hoff and Dr. Patel are both highly experienced in treating sleep apnea patients, including with Inspire therapy.

即使取得了這個重要的里程碑，我們面前還有更多的任務要完成，因為我們在目標市場的滲透率仍然很低，而且我們才剛起步。我們最近也宣布任命 Paul Hoff 博士和 Rahir Patel 博士為副總裁和高級醫療主任。Hoff 博士和 Patel 博士在治療睡眠呼吸中止症患者方面都擁有豐富的經驗，包括 Inspire 療法。

Dr. Hoff brings a focus from the ENT surgeons' perspective, while Dr. Patel will leverage his expertise in sleep medicine. They will play key roles in guiding Inspire's medical education, training and technology development activities. In addition to the focus on these newly appointed positions, both Dr. Hoff and Dr. Patel will maintain their clinical practices independent from Inspire.

霍夫醫師從耳鼻喉科醫師的角度進行探討，而帕特爾醫師將運用他在睡眠醫學方面的專業知識。他們將在指導 Inspire 的醫學教育、培訓和技術開發活動中發揮關鍵作用。除了專注於這些新任命的職位之外，霍夫博士和帕特爾博士都將繼續獨立於 Inspire 進行臨床實踐。

In the first quarter, we continued to expand the limited market release of the Inspire V system in the US and with this gained meaningful experience with Inspire V while concurrently solidifying our inventory levels. As such, we are incredibly excited to announce that we are ready. And we will begin the full launch of the Inspire V system in the US this month. The Inspire V system kick starts the next generation of therapy with the release of this new platform.

第一季度，我們繼續擴大Inspire V系統在美國市場的限量發行，並由此獲得了Inspire V的有意義的經驗，同時鞏固了我們的庫存水準。因此，我們非常高興地宣布我們已經準備好了。我們將於本月在美國全面推出 Inspire V 系統。隨著這個新平台的發布，Inspire V 系統開啟了下一代治療。

Incorporating accessing into the neurostimulator provides a stable sensing environment, which is key to our differentiated closed-loop hypoglossal nerve stimulation system. The added technical capabilities of the device provides the basis for future therapy enhancements including sleep protection and broader therapy indications.

將訪問納入神經刺激器可提供穩定的感知環境，這是我們差異化的閉環舌下神經刺激系統的關鍵。該設備增加的技術能力為未來治療增強提供了基礎，包括睡眠保護和更廣泛的治療適應症。

From a financial perspective, we had a strong first quarter generating revenue of $201.3 million, representing a 23% increase compared to the first quarter of 2024. Net income for the first quarter was $3 million represented diluted net income of $0.10 per share as compared to a net loss of $10 million representing a net loss of $0.34 per share in the first quarter of 2024.

從財務角度來看，我們第一季表現強勁，營收達 2.013 億美元，與 2024 年第一季相比成長了 23%。第一季淨收入為 300 萬美元，即每股稀釋淨收入 0.10 美元，而 2024 年第一季淨虧損為 1,000 萬美元，即每股淨虧損 0.34 美元。

Looking forward to the balance of 2025, we are reiterating our full year 2025 revenue guidance of $940 million to $955 million, representing 17% to 19% growth year-over-year. Regarding profitability, we are increasing our full share diluted net income guidance, to be in the range of $2.20 to $2.30 per share. As we initiate the full launch of the Inspire V system, we anticipate the second quarter will be a transition quarter as we work through the steps necessary to launch this system.

展望 2025 年餘下時間，我們重申 2025 年全年營收預期，即 9.4 億美元至 9.55 億美元，年增 17% 至 19%。關於獲利能力，我們將提高全年稀釋淨收入預期，至每股 2.20 美元至 2.30 美元之間。隨著我們開始全面推出 Inspire V 系統，我們預計第二季度將是一個過渡季度，因為我們將完成推出該系統所需的步驟。

For centers, this process includes a contract amendment, implementation of the new physician programmer and working through the Inspire IV inventory. Our experience to date with the Inspire V system has been very positive and well received by health care providers, especially with ENT surgeons. Since the start of the limited market release last year, we have continued to add additional centers and increase the number of patients receiving the new device.

對於中心來說，這個過程包括合約修改、新醫生程式設計師的實施以及透過 Inspire IV 庫存進行工作。到目前為止，我們對 Inspire V 系統的體驗非常積極，並受到醫療保健提供者，尤其是耳鼻喉科醫生的好評。自去年開始有限量上市以來，我們不斷增加中心並增加接受新設備的患者數量。

This led to an increased general awareness of the pending Inspire V launch. And late in the first quarter and continuing into the second quarter, we started to see evidence of patients waiting for the new device. Combining this with centers working through the launch process, we expect the second quarter to be a transition quarter and for revenue to grow mid- to high single digits sequentially.

這提高了人們對即將推出的 Inspire V 的普遍認識。在第一季末以及進入第二季後，我們開始看到患者等待新設備的證據。結合各中心正在進行的啟動過程，我們預計第二季度將是一個過渡季度，收入將連續實現中高個位數成長。

As the full launch of Inspire V system progresses, we expect a strong second half of 2025. And as such, we are reiterating our full year revenue guidance and raising our EPS guidance. Detailed performance data in the Inspire V system is being closely tracked and initial data will be presented at the upcoming Sleep Conference. Regarding reimbursement of the Inspire V system.

隨著 Inspire V 系統的全面推出，我們預計 2025 年下半年將表現強勁。因此，我們重申全年營收預期並提高每股盈餘預期。Inspire V 系統的詳細性能數據正在密切跟踪，初始數據將在即將召開的睡眠會議上公佈。關於 Inspire V 系統的報銷。

On our last call, we detailed the transition to CPT Code 64568. We are happy to announce that this code has been incorporated into policies covering approximately 80% of our over 300 million covered lives. This includes commercial payers, Medicare and the VA system. We expect to submit for regulatory approval of the Inspire V system in Europe and in Asia this year and will continue to provide the Inspire IV system during the review processes.

在我們上次通話中，我們詳細介紹了向 CPT 代碼 64568 的過渡。我們很高興地宣布，該準則已被納入到覆蓋我們 3 億多受保人群中約 80% 的保單中。其中包括商業付款人、醫療保險和退伍軍人事務部系統。我們預計今年將向歐洲和亞洲提交 Inspire V 系統的監管批准，並將在審查過程中繼續提供 Inspire IV 系統。

We also plan to initiate a focused patient marketing and education program to announce the full launch of the Inspire V system. Prior to launching of Inspire V, we had deliberately pulled back on patient marketing, but expect to step this up in the second quarter and throughout the rest of 2025. This will focus on the education and awareness of the Inspire V system and aim to increase patients visiting our website and inquiring about making contact with a health care provider.

我們還計劃啟動一項針對患者行銷和教育計劃，以宣布全面推出 Inspire V 系統。在推出 Inspire V 之前，我們曾刻意減少了針對患者的行銷，但預計在第二季以及 2025 年剩餘時間內將加大行銷力度。這將側重於 Inspire V 系統的教育和宣傳，旨在增加訪問我們網站的患者並詢問如何與醫療保健提供者聯繫。

To further support this, during the early part of the year, we continued our efforts to expand utilization of digital scheduling within implanting centers. As a reminder, digital scheduling is an online tool used by our advisor care program to submit appointment requests to qualified health care providers on behalf of prospective patients. Digital scheduling significantly streamlines a patient's request to schedule that important first appointment.

為了進一步支持這一點，在今年年初，我們繼續努力擴大植入中心內數位化調度的使用率。提醒一下，數位排程是我們的顧問護理計劃使用的線上工具，用於代表潛在患者向合格的醫療保健提供者提交預約請求。數位化排程大大簡化了病患安排重要首次預約的請求。

With respect to our market development activities, we continue to advance our medical education programs. In the first quarter, we hosted over 300 physicians at Inspire programs, including 120 soon to be graduating ENT physicians, over 110 sleep fellows and introduced Inspire therapy to 90 new ENT residents.

關於我們的市場開發活動，我們繼續推進我們的醫學教育計劃。在第一季度，我們接待了 300 多名參加 Inspire 計畫的醫生，其中包括 120 名即將畢業的耳鼻喉科醫生、110 多名睡眠研究員，並向 90 名新的耳鼻喉科住院醫師介紹了 Inspire 療法。

We remain committed to our mission to educate the next generation of sleep and ENT leaders. In addition, this year, we trained over 100 advanced practice providers, bringing the total inception to date to over 400 ACPs trained. We plan to increase the investments we are making in our medical education programs, including ongoing resident, fellowship.

我們始終致力於培養下一代睡眠和耳鼻喉科領導者的使命。此外，今年我們培訓了 100 多名高級執業醫師，迄今為止，我們培訓的 ACP 總數已超過 400 名。我們計劃增加對醫學教育計畫的投資，包括持續住院醫師培訓和獎學金。

And ACP training, participating in cardiology and primary care conferences and a continuing medical education program to support the awareness and adoption of Inspire therapy in Cardiology and Primary Care. 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 high-quality patient flow and increasing the capacity of our provider partners to effectively treat and manage more patients.

以及 ACP 培訓、參加心臟病學和初級保健會議和繼續醫學教育計劃，以支持對心臟病學和初級保健中的 Inspire 療法的認識和採用。總之，我們將繼續關注患者，並繼續推動 Inspire 療法的發展和應用。我們將執行我們的成長策略，推動高品質的患者流動，並提高我們的醫療合作夥伴有效治療和管理更多患者的能力。

Our key strategies included adding advanced practice providers, certifying additional surgeons qualified implant Inspire therapy and driving the adoption of SleepSync and our digital tools, all of which are embedded strategies in our commercial team's objective to increase provider capacity. 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.

我們的關鍵策略包括增加高級實踐提供者、認證更多外科醫生獲得植入 Inspire 療法的資格以及推動採用 SleepSync 和我們的數位工具，所有這些都是我們商業團隊提高提供者能力的目標中的嵌入式策略。展望未來，我們仍然對未來充滿興奮，並相信我們已經制定了適當的策略來推動長期利害關係人的價值。

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

說到這裡，我想把電話轉給里克，讓他對我們的財務狀況進行評估。

Thank you, Tim, and good afternoon, everyone. Total revenue for the quarter was $201.3 million, a 23% increase from the $164 million generated in the first quarter of 2024. US revenue in the quarter was $193.6 million, an increase of 24% from the $155.8 million in the prior year period. Revenue outside the US was $7.7 million, which was a 6% decrease year-over-year.

謝謝你，提姆，大家下午好。本季總營收為 2.013 億美元，較 2024 年第一季的 1.64 億美元成長 23%。本季美國營收為 1.936 億美元，較去年同期的 1.558 億美元成長 24%。美國以外地區的收入為 770 萬美元，年減 6%。

As a reminder, European revenue in the first quarter of 2024 benefited from the pent-up demand created by the supply shortage resulting from the EU MDR approval delay in the fourth quarter of 2023 and as we transition from polyurethane to silicone-based leads. Gross margin in the quarter was 84.7%, which was stable with the prior year period.

提醒一下，2024 年第一季的歐洲收入受益於 2023 年第四季度歐盟 MDR 批准延遲導致的供應短缺以及我們從聚氨酯向有機矽基導線過渡所造成的被壓抑的需求。本季毛利率為84.7%，與去年同期持平。

Total operating expenses for the quarter were $172.1 million, an increase of 11% as compared to $154.5 million in the first quarter of 2024. This planned increase was primarily due to the expansion of our sales organization and increased general corporate costs partially offset by a reduction in R&D and patient marketing expenses year-over-year.

本季總營運費用為 1.721 億美元，較 2024 年第一季的 1.545 億美元成長 11%。這項計畫成長主要歸因於我們銷售組織的擴張和一般公司成本的增加，但被研發和病患行銷費用的年減部分抵銷。

Interest and dividend income totaled $5.1 million in the quarter compared to $5.9 million in the prior year period. Operating loss for the quarter totaled $1.5 million compared to $15.2 million in the prior year period. Net income for the quarter was $3 million or a 1% net income margin compared to a net loss of $10 million or a 6% net loss in the prior year period.

本季利息和股息收入總計 510 萬美元，而去年同期為 590 萬美元。本季營業虧損總計 150 萬美元，而去年同期的營業虧損為 1,520 萬美元。本季淨收入為 300 萬美元，淨收入率為 1%，而去年同期淨虧損為 1,000 萬美元，淨虧損率為 6%。

This represented diluted net income per share of $0.10 compared to a net loss of $0.34 in the first quarter of 2024. Adjusted EBITDA totaled $33.2 million or a 16% adjusted EBITDA margin in the first quarter compared to $11.9 million and 7% respectively, in the first quarter of 2024. The weighted average number of diluted shares outstanding in the quarter was $30.5 million.

這意味著每股攤薄淨收入為 0.10 美元，而 2024 年第一季的淨虧損為 0.34 美元。第一季調整後 EBITDA 總計 3,320 萬美元，調整後 EBITDA 利潤率為 16%，而 2024 年第一季分別為 1,190 萬美元和 7%。本季流通在外稀釋股份的加權平均數為 3,050 萬美元。

We ended the quarter with $414 million in cash and investment balances. The reduction in our cash position is attributed to $75 million of share repurchases and cash used in operating activities, including building Inspire V inventory balances. This strong cash position allows us to remain focused on executing our growth strategies.

本季末我們的現金和投資餘額為 4.14 億美元。我們的現金狀況的減少歸因於 7500 萬美元的股票回購和經營活動中使用的現金，包括建立 Inspire V 庫存餘額。強勁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 2025 guidance. We continue to expect full year revenue to be in the range of $940 million to $955 million, representing an increase of 17% to 19% compared to full year 2024 revenue. As Tim noted, we are initiating the full launch of Inspire V this month. As such, the second quarter will be a transition quarter and we may see some inventory destocking of Inspire IV and patient warehousing for Inspire V.

繼續推進 2025 年指導。我們繼續預計全年營收將在 9.4 億美元至 9.55 億美元之間，與 2024 年全年營收相比成長 17% 至 19%。正如蒂姆所說，我們將於本月全面推出 Inspire V。因此，第二季度將是一個過渡季度，我們可能會看到 Inspire IV 的一些庫存減少，以及 Inspire V 的耐心倉儲。

Therefore, we expect to grow revenue sequentially from Q1 to Q2 and by mid- to high single digits. We continue to expect full year gross margin to be in the range of 84% to 86%. We now expect diluted net income for the full year 2025 will be $2.20 to $2.30 per share, an increase from our previous range of $2.10 to $2.20 per share. We ended the quarter with 343 US territories and 245 US field clinical representatives.

因此，我們預計第一季至第二季的營收將環比成長中高個位數。我們繼續預計全年毛利率將在 84% 至 86% 之間。我們現在預計 2025 年全年稀釋淨收入將為每股 2.20 美元至 2.30 美元，高於我們之前的每股 2.10 美元至 2.20 美元的範圍。本季結束時，我們在美國擁有 343 個領土，美國實地臨床代表有 245 名。

We continue to expect our reported tax rate in 2025 to be roughly 10%, primarily related to state and local taxes. We expect the full year diluted shares outstanding to be approximately $31 million. As previously noted, our products are currently sourced and assembled primarily in the US and our exposure to recently implemented tariff policies is de minimis.

我們繼續預期 2025 年的申報稅率約為 10%，主要與州稅和地方稅有關。我們預計全年稀釋流通股數約為 3,100 萬美元。如前所述，我們的產品目前主要在美國採購和組裝，因此我們受最近實施的關稅政策的影響極小。

In conclusion, our strong performance and business momentum provide us with confidence in our outlook for 2025. With that, our prepared remarks are concluded.

總而言之，我們強勁的業績和業務勢頭使我們對 2025 年的前景充滿信心。我們的準備演講到此結束。

Dilam, you may now open the line for questions.

迪拉姆，你現在可以開始提問了。

(Operator Instructions) Travis Steed, Bank of America Securities.

（操作員指示）美國銀行證券的 Travis Steed。

First, congrats on profitability this quarter, but I actually wanted to focus on the Q2 revenue guidance and the destock and the patient warehousing that you mentioned, I think it's in the 10-K as well or 10-Q. First of all, maybe just like what happens kind of versus expectations there? Is the impact in the quarter, basically the kind of $12 million delta between your 2Q guidance and the Street number?

首先，恭喜本季獲利，但我實際上想專注於第二季的收入指引以及您提到的去庫存和耐心倉儲，我認為這也在 10-K 或 10-Q 中。首先，也許就像發生的事情與預期相反？本季的影響基本上是您第二季的預測和華爾街預測數字之間的 1200 萬美元差額嗎？

And how do you rate the full year guidance? Do you expect that to kind of be made up in Q3 and Q4 to be able to reiterate the full year guidance.

您如何評價全年業績指引？您是否預計第三季和第四季能夠彌補這一損失，以便能夠重申全年指引？

Yes. Travis, I think as we started to expand the Inspire V limited market release, work got out and the awareness of the technology and the pending launch became more prevalent. And we started to see more the patient warehousing. We knew as we were going to launch Inspire V, there would be a transition period with centers working through the contracts, working through getting the new physician program as well as working through their Inspire IV inventory.

是的。崔維斯，我認為，隨著我們開始擴大 Inspire V 的限量市場發行，工作開始展開，人們對這項技術和即將推出的產品的認識也變得更加普遍。我們開始看到更多的患者倉儲。我們知道，當我們準備推出 Inspire V 時，會有一個過渡期，中心需要完成合約、獲得新的醫生計劃以及處理他們的 Inspire IV 庫存。

So that's why we expect with the number of patients waiting for therapy with the V until such time as it's available. That we would see the second quarter affected, and that's why we'll still see a good step-up in Q2, but as we mentioned in the mid- to high single digits. And yes, we do plan to make that up throughout the year as we continue to launch and grow the utilization of Inspire V. .

因此，我們預計會有大量患者等待 V 療法，直到該療法可用。我們會看到第二季度受到影響，這就是為什麼我們仍然會看到第二季度出現良好的成長，但正如我們所提到的，成長率在中高個位數之間。是的，我們確實計劃在全年繼續推出 Inspire V 並擴大其使用率的同時，彌補這一不足。。

Danielle Antalffy, UBS.

瑞銀的丹妮爾·安塔爾菲 (Danielle Antalffy)。

Congrats on a really strong start to the year. Just if I could follow up on the cadence commentary for the year. I guess, how much confidence do you have in as far as how much Inspire IV inventories in the marketplace right now? And I guess sort of that number you're putting out there for Q2 and that you can sort of make up for some of that in Q3 and Q4.

祝賀您今年取得了非常強勁的開局。只是如果我能跟進今年的節奏評論就好了。我想，就目前市場上的 Inspire IV 庫存量而言，您有多大信心？我猜你公佈的第二季的數字可以在第三季和第四季彌補一些。

Just curious about what level of visibility you guys have into that? And how confident can we be because obviously, back half loaded guidance can sometimes make people a little nervous. So just wondering if you could give a little bit more color.

我只是好奇你們對此有何了解？我們能有多大信心，因為很明顯，半負荷的指導有時會讓人有點緊張。所以我只是想了解一下您是否可以提供更多細節。

Absolutely, Danielle. Thank you very much. We have close knowledge of the inventory on the field. The majority of the centers only have a couple of units on the shelf. Those centers that are the high-volume centers will have a higher number of Inspire, but they also do -- they tend to be the quartile on centers that do a significant number of implants on a monthly basis.

當然，丹妮爾。非常感謝。我們對現場的庫存情況有深入的了解。大多數中心的貨架上只有幾台設備。那些手術量較大的中心將擁有更多的 Inspire 數量，但它們也往往是每月大量植入的中心中的四分位數。

So they'll be able to work through the majority of that inventory in a short period of time in the second quarter. And once they work through that Inspire IV for inventory, there's a replacement with the Inspire V inventory. So we do have confidence in this back half of the year as we continue to ramp and expand the full launch of V. But we do have, can closely monitor existing IV inventory, and that's why we have confidence that the majority of the units and the inventory burn down will be accomplished in the second quarter.

因此他們將能夠在第二季的短時間內處理掉大部分庫存。一旦他們用完 Inspire IV 的庫存，就會用 Inspire V 庫存進行替換。因此，我們對今年下半年充滿信心，因為我們將繼續加強並擴大 V 的全面發布。但我們確實可以密切監控現有的 IV 庫存，這就是為什麼我們有信心大部分單位和庫存消耗將在第二季完成。

Robbie Marcus, JPM.

羅比·馬庫斯（JPM）。

Great. I'll add my congratulations on a nice quarter. Sorry to keep on this, but maybe just a follow-up on the question there. And is the way we should be thinking about this, you had very good procedure volume growth in sales in first quarter. There is some lower number of procedures in second quarter, call it, the $10 million to $15 million that's getting -- that's lower than the Street, but maybe not quite as much as that because you're eating into existing inventory?

偉大的。我要對這個美好的季度表示祝賀。很抱歉繼續這個問題，但也許只是對這個問題的後續跟進。我們應該這樣考慮這個問題，第一季的銷售程序量成長非常好。第二季度的程序數量有所減少，大概在 1000 萬到 1500 萬美元之間——這比華爾街的預測要低，但可能沒有那麼多，因為你們正在蠶食現有庫存？

And then we'll get that restocking in third and into fourth quarter? And I guess the question I really have is, how should we think about the balance of restocking? And how should we think about the sizing of the pent-up demand? And is the system ready? Is it a big amount of patients that are being warehoused that gives you the confidence in the back half of the year? And it's just you're seeing some lead down of inventory and some delay of procedures, and that's why you're not raising guidance for the year.

然後我們會在第三季和第四季補貨嗎？我想我真正想問的問題是，我們該如何考慮補貨的平衡？我們該如何考慮被壓抑的需求的規模？系統準備好了嗎？是不是大量的病人被收治，讓你對下半年的業績充滿信心？只是您看到庫存有所下降，程序有所延遲，這就是您沒有提高今年的指導的原因。

Thanks, Robbie. Great question. The getting into detail. The first thing that's always strong with the patient’s outcomes and our awareness programs, the patient full always remains strong. And we continue to add centers, we continue to grow the utilization, and we continue to help patients make that first connection. So the front of the funnel remains very, very strong, and that's what gives us confidence going forward.

謝謝，羅比。好問題。深入細節。對於患者的結果和我們的意識計劃來說，第一件事就是讓患者始終保持堅強。我們將繼續增加中心，繼續提高利用率，並繼續幫助患者建立初步聯繫。因此，漏斗前端仍然非常非常強勁，這給了我們前進的信心。

We do know that we have to work in process of activating these centers. and we do have to burn down the Inspire IV inventory. But the key is to continue to grow the number of implants and you kind of hinted at that in your question that yes, we're going to still do implant with Inspire IV in the second quarter, but you're going to see a little bit of a shift until the Inspire V inventory comes in and replaces that.

我們確實知道我們必須在激活這些中心的過程中開展工作。並且我們必須燒毀 Inspire IV 庫存。但關鍵是繼續增加植入物的數量，您在問題中暗示了這一點，是的，我們在第二季度仍將對 Inspire IV 進行植入，但在 Inspire V 庫存到位並取代它之前，您會看到一點點變化。

So while we are doing the full launch this month, there is a little bit of a transition process for centers to get up and running with V. But the strength that we have is the demand with the patient flow remains very, very strong. And that's what's really encouraging to us as we lean forward and have confidence going into the second half of the year. .

因此，雖然我們本月將全面推出 V，但各中心仍需要經歷一個過渡過程才能順利啟動並運作。但我們的優勢在於，患者流量的需求仍然非常強勁。這對我們來說是真正令人鼓舞的，因為我們對下半年充滿信心。。

Adam Maeder, Piper Sandler.

亞當梅德、派珀桑德勒。

Congrats on a nice quarter and the full launch of Gen V this month. I wanted to ask maybe just one more on Gen V the level of confidence that you have to kind of take that next step from a launch standpoint, really, just around manufacturing, reimbursement and device performance. Presumably, you're pleased with the progress you made in each of those different areas.

恭喜本季取得良好業績並於本月全面推出 Gen V。我想再問一個關於第五代的問題，從發布的角度來看，您對邁出下一步有多大的信心，實際上，只涉及製造、報銷和設備性能。想必您對自己在各個不同領域的進展感到滿意。

But there has been some speculation around why the rollout hasn't gone faster. So I just wanted to give you the opportunity to add a little bit more color there with what you're seeing and the progress that you're making in those different areas?

但對於為何推出速度沒有加快，存在一些猜測。所以我只是想給你機會，根據你所看到的以及你在這些不同領域所取得的進展，來添加一些色彩？

Okay. Sure, Adam. Thanks very much. Well, first off, the device is fully approved. And so we submitted to the FDA the full data set that we had, the full qualification. And so it's been under tight review and we're very confident in the performance of the device. We have done the work in Singapore, as you recall, we have done significant number of centers and implants in our limited market release.

好的。當然，亞當。非常感謝。首先，該設備已獲得完全批准。因此，我們向 FDA 提交了我們擁有的完整資料集和完整資格。因此，它一直受到嚴格的審查，我們對該設備的性能非常有信心。正如您所記得的，我們已經在新加坡開展了這項工作，我們在有限的市場發布中完成了大量的中心和植入物。

So full confidence in the product moving forward. The challenge that we had is wrapping up the manufacturing facility to have standard processes such that we could have the throughput and the starting inventory to support the full launch. And we do a significant number of implants on a monthly basis more so than we did, obviously, when we did Inspire IV back in 2018.

因此對產品的發展充滿信心。我們面臨的挑戰是完善製造設施，使其擁有標準流程，以便我們能夠擁有足夠的產量和起始庫存來支援全面推出。我們每月進行的植入數量明顯比 2018 年植入 Inspire IV 時多得多。

So we needed a strong inventory level to do the full launch. And we now have stable manufacturing. We do have good inventory levels. We've always had confidence in the Inspire V technology. And we're really liking the response that we're seeing from the health care providers, specifically the Inspire V experienced surgeons who don't no longer have to implant the pressure sensing lead, which we all know has been the most uncomfortable step of the process for Inspire implanting's with the ENT surgeons.

因此我們需要強大的庫存水準來全面推出產品。現在我們的生產已經穩定。我們的庫存水準確實良好。我們一直對 Inspire V 技術充滿信心。我們真的很喜歡從醫療保健提供者那裡看到的反饋，特別是 Inspire V 經驗豐富的外科醫生，他們不再需要植入壓力感測導線，我們都知道這是耳鼻喉外科醫生在 Inspire 植入過程中最不舒服的一步。

So we just needed to make sure that we were ready that we had all the key elements in order. And so from a technology to a product, to the approval, to the reimbursement, as we mentioned and the support with the policies with the new code 64568. And finally, with the proper inventory levels, we're ready to throw the switch and be able to move into full launch.

因此，我們只需要確保我們已經做好準備，並且所有關鍵要素都已準備就緒。因此，從技術到產品、到批准、到報銷，正如我們所提到的，以及對新代碼 64568 的政策的支持。最後，有了適當的庫存水平，我們就可以開始轉換並全面啟動了。

Richard Newitter, Truist.

Richard Newitter，Truist。

Nice first quarter here. Maybe you can frame for us the reiterated revenue range for the year. One, when you originally provided that guidance, what was assumed or were you assuming any transition situation that would require kind of inventory work out. And then B, can you talk to the bottom and top end of your range right now.

這裡的第一季很不錯。也許您可以為我們確定今年的重申收入範圍。第一，當您最初提供該指導時，您假設了什麼，或者您是否假設了需要進行庫存整理的任何過渡情況。然後 B，您能談談您現在的範圍的底端和頂端嗎？

We're just trying to figure out what kind of cushion is built in and how much you into what normally is a cushion provided guidance range. So if you could just talk to what gets you to the upper end, what gets you to lower end with respect to the various components of capacity, Inspire V and enabling increased capacity and kind of some of the dynamics now that you're introducing with the 2Q revenue push out.

我們只是想弄清楚內建了什麼樣的緩衝墊，以及您在通常緩衝墊提供的指導範圍內能獲得多少緩衝墊。因此，如果您可以談談什麼使您達到高端，什麼使您達到低端，就容量的各個組成部分而言，Inspire V 和實現增加的容量以及您現在在第二季度收入推動中引入的一些動態。

Got you, Rich. Well, the key is from a full year, we haven't changed. And we start out confidence in that full year. And we knew we were going to do an Inspire V launch during the year sometime, and we wouldn't be working through the inventory. So not a lot of change there. And really, what's clarifying here is our ability to do the full launch right now.

明白了，里奇。嗯，關鍵是從整整一年來看，我們沒有改變。我們對這一整年都充滿信心。我們知道我們將在今年某個時候推出 Inspire V，而且我們不會透過庫存來開展工作。因此那裡沒有太多變化。實際上，這裡要澄清的是我們現在是否有能力進行全面發布。

And with our limited release, we saw a little bit more of the patient awareness and wanting to wait for the new device. And I think that's become evident really most recently, late Q1 and into the second quarter that we started to see that. And that kind of shifts the mix of -- or the timing of the revenue and where Inspire V comes in. So not a lot of changes in our overall annual planning.

隨著我們限量發售，我們發現患者的意識有所增強，並且希望等待新設備。我認為這一點最近才變得明顯，在第一季末和第二季度，我們開始看到這一點。這會改變收入的組合或時間以及 Inspire V 的發揮作用的地方。因此我們的整體年度計劃沒有太大變化。

But again, we knew we were going to work through the Inspire IV inventory just a timing issue as we do the full launch in the second quarter. And hand off to Rick for additional comments.

但是，我們知道我們將處理 Inspire IV 庫存，這只是一個時間問題，因為我們將在第二季度全面推出。並將其交給 Rick 以獲得更多評論。

Yes. We did say at the beginning of the year that we did expect our full year revenue to be a little more heavily back-end weighted. And given the Q2 launch dynamics, as we talked about, we are expecting some utilization improvements in the second half. And we expect Q4 to be a little bit stronger than our historical levels. .

是的。我們確實在年初就說過，我們預計全年收入中後端收入的比重會更大一些。正如我們所討論的，考慮到第二季的發布動態，我們預計下半年利用率會有所提高。我們預計第四季的表現將比歷史水準略強一些。。

Kallum Titchmarsh, Morgan Stanley.

摩根士丹利的卡勒姆·蒂奇馬什 (Kallum Titchmarsh)。

From your initial rollout of Inspire V and the limited launch, I assume the majority of these surgeons were Sleep specialists. But I'm curious if you were able to target any of those generalist ENTs that you think could eventually be the driver of a broadening surgeon, Paul. Just maybe talk us through how you plan on onboarding these generalist ENTs as you enter the full market launch in May and how that may differ from your strategy with the bulk of active implants today?

從您最初推出的 Inspire V 和有限的發布來看，我認為這些外科醫生中的大多數都是睡眠專家。但我很好奇，保羅，您是否能夠針對那些您認為最終可能成為擴大外科醫生的推動者的全科耳鼻喉科醫生。您能否向我們介紹一下，當您在 5 月全面進入市場時，您計劃如何讓這些全科耳鼻喉科醫生加入進來，以及這與您目前針對大部分主動植入物的策略有何不同？

No, absolutely. Thank you. I think the key is when we do new launches like this, when we do critical studies, when we do research, obviously, we partner with a lot of our key physicians at the academic centers. But in our limited market launch, in that it is a commercial launch, albeit limited. We do want to involve the commercial centers and the general practice ENTs to get a good balance when we do that limited launch.

不，絕對不是。謝謝。我認為關鍵在於，當我們進行這樣的新產品發佈時，當我們進行批判性研究時，當我們進行研究時，顯然我們會與學術中心的許多主要醫生合作。但在我們的有限市場發布中，儘管有限，但這是商業發布。我們確實希望在有限的發布過程中讓商業中心和全科耳鼻喉科參與進來，以達到良好的平衡。

So it is a balance between the two groups, both academic as well as the general ENTs, and that gives us confidence to move forward with the full launch of Inspire V. So we have had the ability to talk with both groups. They have confidence with our training programs. So as we introduced V broadly in the US that the training programs will go very swiftly.

因此，這是學術群體和普通 ENT 兩個群體之間的平衡，這使我們有信心全面推出 Inspire V。因此我們有能力與這兩個群體進行交談。他們對我們的培訓計劃充滿信心。因此，當我們在美國廣泛推出 V 時，培訓計劃將會進展得非常迅速。

The ENTs that have done performed Inspire V implants have responded very favorably. And we expect a pretty seamless transition moving forward. .

已實施 Inspire V 植入的耳鼻喉科醫師反應非常好。我們期望未來的過渡能夠順利進行。。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Congrats on the start to the year here. Wanted to ask about so far and what's implied in the guide. If you look at the last couple of quarters, you've grown OpEx well below half of that about the top line is. And if you continue that for the rest of the year, you're getting somewhere ahead of what the guidance for 2025 is at this point.

祝賀新的一年的開始。想詢問到目前為止的情況以及指南中暗示的內容。如果你回顧過去幾個季度，你會發現營運支出的成長遠低於營收的一半。如果你在今年剩餘時間裡繼續保持這種勢頭，那麼你將比目前的 2025 年預期目標有所進步。

So I'm just curious on what your assumptions are in the implied guide on EPS this year and whether or not we should be thinking about some incremental step-up or acceleration and spend behind the Inspire V launch.

所以我只是好奇你對今年 EPS 的隱含指南的假設是什麼，以及我們是否應該考慮在 Inspire V 推出後進行一些漸進式的提升或加速和支出。

Yes. Thanks for the question. We're going to continue to invest in our operating expenses to drive top line. And we continue to expect that revenue on an annual basis will outpace OpEx growth. But really, we are going to continue to slightly increase our DTC on a year-over-year basis.

是的。謝謝你的提問。我們將繼續投資營運費用來推動營收成長。我們仍然預期年度收入的成長速度將超過營運支出的成長速度。但實際上，我們將繼續同比略微增加我們的 DTC。

We are going to spend more in patient marketing with the Inspire V launch, as Tim mentioned. R&D is going to continue to run at mid-teens. That does fluctuate a little bit. And then stock-based compensation on an annual basis, too, is going to continue to increase. And with that net-net is really going to get us to mid-single digits from an operating margin standpoint on an annual basis.

正如蒂姆所提到的，隨著 Inspire V 的推出，我們將在患者行銷方面投入更多資金。研發將繼續以十幾歲的速度運轉。這確實有點波動。然後，年度股票薪酬也將繼續增加。有了這個淨額，從年度營業利潤率的角度來看，我們的年度淨額確實會達到中等個位數。

Michael Sarcone, Jefferies.

薩科內（Michael Sarcone），傑富瑞集團（Jefferies）。

Just one on the Inspire V launch and CPT code 64568, it's been a few months of the limited market release now. I was wondering if you could just give us some commentary on how physicians are responding to the lower professional fee that comes with the 64568 code and are you seeing any increased procedures in a day to offset that. Would love to hear what the experience has been so far.

Inspire V 發佈時僅有一款，CPT 代碼為 64568，目前已在市場上限量發售幾個月了。我想知道您是否可以給我們一些評論，關於醫生對 64568 代碼帶來的較低專業費用的反應如何，以及您是否看到一天內有任何增加的程序來抵消這種影響。很想聽聽迄今為止的經驗。

Yes, absolutely. Thanks, Mike. I think we're going to track that very closely going forward. We have confidence in the reimbursement levels with 64568 and $200 reduction with Medicare across the board. I think a lot of the limited live centers were academic. So they're not as effective, but equally balance is the commercial centers with -- as we talked about general ENTs from a couple of questions earlier on that they're comfortable with the procedure.

是的，絕對是。謝謝，麥克。我認為我們今後將會密切關注這一點。我們對 64568 美元的報銷水平以及全線醫保減免 200 美元充滿信心。我認為很多有限的現場中心都是學術性的。因此它們不那麼有效，但商業中心也同樣平衡——正如我們之前在幾個問題中談到的一般耳鼻喉科醫生那樣，他們對這種程序感到滿意。

I think a lot of excitement around Inspire V not putting in the pressure testing lead will far outweigh the extra work it takes to do that part of the procedure and not getting paid for the work that they don't do. I think it's been quite balanced so far and the feedback from the physicians is very excited to not have to deal with the pressure sensing lead with the reduced OR time.

我認為，Inspire V 不放入壓力測試導線所帶來的興奮感將遠遠超過完成該部分程序所需的額外工作以及不為他們沒有做的工作獲得報酬。我認為到目前為止一切都相當平衡，醫生們的回饋令人非常興奮，因為他們不必處理壓力感測導線，從而縮短了手術時間。

And just with the ability for them to plan their time consistently without having an implant that pressure sensing lead. So we're going to continue to monitor this as we go through the year to make sure that that physicians are comfortable with 64568 and the reimbursement levels. The other key to it, though, is we're going to track their acceptance of Inspire V.

而他們無需植入壓力感應導線就能持續規劃自己的時間。因此，我們將在全年持續監控這一情況，以確保醫生對 64568 和報銷水準感到滿意。不過，另一個關鍵是我們要追蹤他們對 Inspire V 的接受度。

And we really accept strong acceptance from the surgeons with the simplicity of the procedure compared to Inspire IV. And also remember, there's an increased payment to ambulatory surgical centers with the new code as well. So I think the payers throughout have all been very accepting going to 64568, I think the surgeons will be accepting during the more simpler procedure with the reduced time, with the reimbursement level that's available, and we'll continue to monitor that closely and continue to provide feedback throughout the year.

與 Inspire IV 相比，該手術的簡單性確實得到了外科醫生的強烈認可。還要記住的是，新代碼還會增加對門診手術中心的支付。因此，我認為整個付款人都非常接受 64568，我認為外科醫生會接受更簡單的程序、更短的時間以及可用的報銷水平，我們將繼續密切監測並在全年繼續提供回饋。

Shagun Singh, RBC.

沙根·辛格，RBC。

Great. Just a couple of quick ones for me. So what was the impact of pausing in inventory dynamics in Q1? On Q2, any color on EPS versus prior consensus at $0.41. And then I have a follow-up.

偉大的。對我來說，只有幾個簡單的問題。那麼第一季庫存動態暫停會產生什麼影響？第二季度，每股盈餘（EPS）與先前的預期值（0.41美元）相比，有何變化？然後我再跟進。

Yes. Shagun, regarding Q2, we talked about mid- to-high single-digit sequential revenue growth. And so with that, we are going to spend more in patient marketing with the Inspire V launch. But we do expect to be profitable in Q2, and then to improve that profitability sequentially throughout the year. So maybe a little bit lower in Q2, but lower than current consensus, but we're going to grow that sequentially.

是的。Shagun，關於第二季度，我們談到了中高個位數的連續收入成長。因此，隨著 Inspire V 的推出，我們將在患者行銷方面投入更多資金。但我們確實預計第二季將實現盈利，並在全年逐步提高盈利能力。因此，第二季的銷售額可能會略低一些，但低於目前的共識，但我們會逐步增加銷售額。

But you should also expect sequential EPS growth in Q2 versus Q1.

但您也應該預期第二季的每股盈餘將相對於第一季實現連續成長。

Got it. And what was the impact of pausing an inventory dynamic in Q1?

知道了。那麼，第一季暫停庫存動態會產生什麼影響？

We didn't. I mean, it would have been really difficult to tell. There weren't really a lot of one-time items. And as we said, the patient warehousing didn't manifest until later in Q1. So it would be really difficult to quantify that. Nothing to call out. .

我們沒有。我的意思是，這真的很難說。實際上，一次性物品並不多。正如我們所說，耐心倉儲直到第一季後期才顯現出來。因此，要量化這一點確實非常困難。沒什麼好喊的。。

Got it. And then just as a follow-up. I was wondering if you can comment on profitability. It seems like we've gotten mixed feedback on that. And I'm just wondering why don't you think that could be a bad year to broader option?

知道了。然後只是作為後續行動。我想知道您是否可以評論一下盈利能力。看來我們對此收到了褒貶不一的回饋。我只是想知道為什麼您不認為今年對於更廣泛的選擇來說可能是糟糕的一年？

Yes, absolutely. Thank you. I think as we work with surgeons and work to help streamline their practices and how they introduce their Inspire systems. We can improve their profitability by streamlining their processes. We mentioned earlier that we have trained 100 APPs, advanced practice providers that can really help streamline patient flow through centers it is a much more efficient way for patients and for physicians to build their practices.

是的，絕對是。謝謝。我認為，我們與外科醫生合作，努力幫助他們簡化實踐以及他們如何引入他們的 Inspire 系統。我們可以透過簡化他們的流程來提高他們的獲利能力。我們之前提到過，我們已經培訓了 100 名 APP，這些先進的實踐提供者可以真正幫助簡化患者在中心的流動，這對患者和醫生來說是一種更有效的實踐方式。

And this is pretty common across the higher volume centers where they can build efficiencies by having the surgeon spend more time in the operating room to do more procedures and with the reduced OR time to be able to further build on the profitability. I think in the academic centers and some centers that don't do the same level of procedures, it's more difficult. And maybe that's where some of the feedback comes from.

這在手術量較大的中心相當常見，透過讓外科醫生花更多時間在手術室進行更多手術，他們可以提高效率，並減少手術室時間，從而進一步提高盈利能力。我認為在學術中心和一些不進行相同級別程序的中心，這更加困難。也許這就是部分回饋的來源。

But in the high productive accounts, the ones that do that greatest number of implants. They understand throughput. They know how to leverage APPs. They have strong partnerships with sleep positions to manage the patients longitudinally and have really built efficiencies into the practice to be profitable. .

但在高生產力帳戶中，植入的數量最多。他們了解吞吐量。他們知道如何利用 APP。他們與睡眠診所建立了牢固的合作關係，對患者進行縱向管理，並真正提高了實踐效率，並實現了盈利。。

Chris Pasquale, Nephron Research.

克里斯‧帕斯誇萊 (Chris Pasquale)，腎元研究機構。

Tim, you talked about some early data on Inspire V being presented at some of the upcoming meetings. Curious what you expect that to show. Most of the focus has been on the increased convenience of this form factor. But I think you've also said that you think the accelerometer can actually do a better job with respiratory gating. So do you expect that to manifest in any tangible outcome improvements?

提姆，您談到了即將召開的一些會議上展示的有關 Inspire V 的一些早期數據。好奇你期望它展示什麼。大部分的焦點都集中在這種外形尺寸所增加的便利性。但我認為您也說過，您認為加速度計實際上可以在呼吸門控方面做得更好。那麼，您是否期望這能反映出任何實際的結果改善？

Yes, I think that's kind of the key to it. Yes, everybody is excited because they want to hear numbers about reduced OR time. The safety performance, what kind of -- have you seen any adverse events? Is all procedures completed successfully? And the feedback has been very strong on all of those fronts. But from a patient outcome standpoint that Chris, we always talk about how that's such a high priority for us.

是的，我認為這就是關鍵。是的，每個人都很興奮，因為他們想聽到有關縮短手術時間的數字。安全性能怎麼樣－您看過什麼不良事件嗎？所有程序是否都順利完成？所有這些方面的回饋都非常強烈。但從患者結果的角度來看，克里斯，我們總是談論這對我們來說是多麼重要的優先事項。

We believe that accelerometer or does provide a more stable sensing environment and the data that we provided to the FDA as part of our approval process did show an improved stability. And in Singapore, we actually did a little bit more of a detailed clinical study to capture that data and to capture the utilization or the patient adherence to therapy, and not sure that AHI data will be available.

我們相信加速度計確實提供了更穩定的感測環境，而我們在審批過程中向 FDA 提供的數據確實顯示出穩定性的提高。在新加坡，我們實際上做了更詳細的臨床研究來獲取這些數據並獲得利用率或患者對治療的依從性，但不確定是否可以獲得 AHI 數據。

But that is something we are also tracking as well as we'll continue to attract feedback from all the US centers as part of the limited loss. So yes, when we're coming up by June, we will want to talk about outcomes, more so beyond just the -- what people always talk about with the reduced OR time and we'll talk about surgical times as well.

但這也是我們正在追蹤的事情，作為有限損失的一部分，我們將繼續吸引來自所有美國中心的回饋。所以是的，到六月的時候，我們會談論結果，不僅僅是人們總是談論的縮短手術時間，我們還會談論手術時間。

But to us, it really is a focus on those critical patient outcomes, and we believe that with the improved sensing, and we have new algorithms in the device that we think can further improve our already strong patient outcomes. .

但對我們來說，真正關注的是那些關鍵的患者結果，我們相信，隨著感測技術的改進，我們在設備中採用了新的演算法，我們認為這些演算法可以進一步改善我們已經很好的患者結果。。

Larry Biegelsen, Wells Fargo.

富國銀行的拉里·比格爾森。

Tim, just a multipart question. So when do you expect to complete the transition to Inspire V, last call it was Q4. And so my question is, why won't these factors that you mentioned impact also Q3, given the full launch won't complete until Q4?

提姆，這只是一個由多個部分組成的問題。那麼您預計何時完成向 Inspire V 的過渡，上次是第四季。所以我的問題是，既然全面發布要到第四季度才能完成，為什麼您提到的這些因素不會影響第三季？

And second, Tim, our checks also suggest just linking the Inspire V CPT code to the ICD-10 code for sleep apnea can also slow things down. What are you seeing on that as well?

其次，Tim，我們的檢查還表明，僅將 Inspire V CPT 代碼與睡眠呼吸中止症的 ICD-10 代碼相連結也可以減慢速度。您對此也看到了什麼？

Got you. We talked last call that yes, we would complete the transition by the end of the year. When we stated that, of course, we didn't have the full launch date announced at that time either. So now that we're doing the full launch day, we're going to do everything we can to really pull the individual centers forward. We don't expect to have too much carryover in the third quarter.

明白了。我們最後一次通話時表示，我們將在今年年底前完成過渡。當然，當我們聲明這一點時，我們當時也沒有宣布完整的發布日期。因此，現在我們正在進行完整的發布日，我們將竭盡全力推動各個中心向前發展。我們預計第三季不會有太多結轉。

As Rick mentioned, that we expect to have a stronger Q4 than normal. And again, we're reiterating full year guidance. So we're going to work hard at the field and the physicians are excited for Inspire V. The contracting, as you recall, is quite simple because it's just a one page multi page small contract amendment just changed from IV to V. So that should be pretty simplistic.

正如里克所提到的，我們預計第四季的表現將比往年更強勁。我們再次重申全年指引。因此，我們將在該領域努力工作，醫生們對 Inspire V 感到非常興奮。您還記得，簽訂合約非常簡單，因為它只是一份一頁多頁的小合約修正案，只是從 IV 更改為 V。這應該非常簡單。

And the new physician program, which was launched last year, most centers are ready to take on the new physician programmer. So the transition should not be that difficult. We're going to work very hard in the second quarter, but we'll track that as we get into Q3. And Rick talked about the cadence for the second half of the year.

去年啟動的新醫師計劃，大多數中心都已準備好接受新的醫師程式設計師。因此過渡應該不會那麼困難。我們將在第二季度非常努力地工作，但我們將在進入第三季度時跟踪這一點。瑞克談到了今年下半年的節奏。

As far as the linking to the ICD9 diagnostic code. We're already working with CMS to get that done. As we mentioned before, we already have 80% of our $300 million covered lives. That does include Medicare, that does include commercial payers, does include the VA, and we have overcome that connection that you're talking about because we address that right up front.

至於與 ICD9 診斷代碼的連結。我們已經與 CMS 合作來完成該任務。正如我們之前提到的，我們的 3 億美元保險金中已經有 80% 已經投保了。這確實包括醫療保險，包括商業付款人，包括退伍軍人事務部，我們已經克服了您所說的這種聯繫，因為我們一開始就解決了這個問題。

Anthony Petrone, Mizuho Financial Group.

瑞穗金融集團的安東尼‧佩特羅內 (Anthony Petrone)。

Congrats on the quarter here. Maybe just a question on capacity into the second half. Specifically, you mentioned, Tim, you're adding ENT general surgeons. And obviously, we had a little bit of backlog that's pushed into the second half. Just wondering where that ENT capacity sits today. And is it enough to handle this bolus of volumes in the second half.

恭喜本季取得的成績。也許只是關於下半年產能的一個問題。具體來說，提姆，你提到你正在增加耳鼻喉科普通外科醫生。顯然，我們有一些積壓的工作被推遲到了下半年。我只是想知道 ENT 容量目前處於什麼水平。它是否足以處理下半年的大量需求？

And the quick follow-up there would just be if you can give us any update on sleep sync and how that's evolving or front end of the funnel?

接下來的問題是，您能否向我們提供有關睡眠同步的最新信息，以及它的發展情況或漏斗前端的情況？

Absolutely. Thank you. Talking about capacity first. There's several elements that are in play there. Number one, the Inspire V device is a shorter procedure, allowing existing surgeons to do additional cases in any given day. Number two, we believe that once they start doing this IV, V, and they're comfortable that they know longer have to put in the pressure sensing lead.

絕對地。謝謝。先說容量。那裡有多種因素在起作用。首先，Inspire V 設備的手術過程更短，允許現有的外科醫生在一天內完成更多手術。第二，我們相信，一旦他們開始進行 IV、V 檢查，他們就會感到舒適，知道不再需要插入壓力感測導線。

Again, remember, take putting an acceptor into the chest wall, that will give additional confidence to schedule more cases as well thereby increasing capacity. Two, we believe there are a number of ENT surgeons that just we're reluctant to do the Inspire procedure solely because of that pressure sensing lead. So as we move through the year, we're going to be reaching out to those surgeons to make sure that they understand that Inspire V is now available to be able to make this an important part of their practice going forward.

再次提醒，請記住，將受體放入胸壁，這將為安排更多病例提供額外的信心，從而增加容量。其次，我們相信有很多耳鼻喉外科醫生僅僅因為壓力感測導線而不願意進行 Inspire 手術。因此，隨著時間的推移，我們將與這些外科醫生取得聯繫，確保他們了解 Inspire V 現已可用，以便能夠將其作為未來實踐的重要組成部分。

Number three, we talked about our medical education and the significant number of new ENTs graduating and coming out and excited about including Inspire into their new practice as they go forward. We're going to continue to add new centers as we work through the year, especially those centers coming on training directly into Inspire V.

第三，我們討論了我們的醫學教育，以及大量新畢業的耳鼻喉科醫生對將 Inspire 納入他們未來的新實踐中感到興奮。我們計劃在全年繼續增加新的中心，特別是那些直接接受 Inspire V 培訓的中心。

So it's really going to continue to be strive focused to build this capacity because it continues to be the limiting factor for us from the beginning of the call, one of the earlier questions talked about the number of patients still coming into the pipeline is overwhelming by the capacity that we have to serve these patients. So really going to be a key focus element to it.

因此，我們確實將繼續致力於建立這種能力，因為從通話一開始，這一直是我們的限制因素，而先前討論的一個問題是，仍在等待治療的患者數量與我們為這些患者提供服務的能力不相符。因此這確實會成為其關鍵的焦點元素。

This your second part of your question is a very strong one. We'll start talking about sleep sync. As we increase the number of patients treated, sleep sync provides an opportunity for the sleep physicians to manage a greater number of patients on a longitudinal basis. The majority of the high-volume centers already have SleepSync as part of their practice, and they can leverage that to streamline patient flow and how they manage their patients.

你的問題的第二部分非常有力。我們將開始討論睡眠同步。隨著我們治療的患者數量的增加，睡眠同步為睡眠醫生提供了縱向管理更多患者的機會。大多數高容量中心已經將 SleepSync 作為其實踐的一部分，他們可以利用它來簡化患者流程以及他們對患者的管理方式。

What's key to Inspire V is, Inspire V, the new physician programmer leverages SleepSync and logs into Sleeping to be able to provide data directly into the cloud-based patient management system. So those centers that are on SleepSync have an easy transition in. And as Rick mentioned on our R&D investments going forward, we're going to continue to invest heavily in our digital tools and a lot of that is all about SleepSync to really help the patient be part of their own care with the app.

Inspire V 的關鍵在於，Inspire V，新的醫生程式設計師利用 SleepSync 並登入 Sleeping 能夠將資料直接提供給基於雲端的病患管理系統。因此那些使用 SleepSync 的中心可以輕鬆過渡。正如 Rick 提到的我們未來的研發投資，我們將繼續大力投資我們的數位工具，其中很大一部分都與 SleepSync 有關，旨在真正幫助患者使用該應用程式參與自己的護理。

But really, they also be able to help patient monitoring and help physicians be able to track how well their patients are going with Inspire therapy. So a pretty intense question, and hopefully, I got the right answers all to you there.

但實際上，它們也能夠幫助患者監測，並幫助醫生追蹤患者接受 Inspire 療法的進展。這是一個相當尖銳的問題，希望我能提供你們正確的答案。

John Block, Stifel.

約翰·布洛克（John Block），斯蒂費爾（Stifel）。

Great. Maybe two parter of the 1,500 centers, Tim, what was like the sort of incoming where delays were or are taking place. And I'm just curious, was it a couple of hundred centers heard about ? Was it much more pervasive than that and across most of the centers? Any details would be appreciated. And then this is sort of a follow-up to a prior question, but I just want to make sure I've got it clear.

偉大的。提姆，也許在 1,500 個中心中有兩個中心出現延誤，或者正在出現延誤。我只是好奇，聽過幾百個中心嗎？？它是否比這更普遍並且覆蓋了大多數中心？任何詳細資訊都將不勝感激。這是對之前問題的後續回答，但我只是想確保我已經把問題說清楚了。

So the prior plan was to have, I think, on the last call, all the centers trained by the end of 2025. I think you were citing like full conversion by the end of '25. Are you now talking about full conversion by, call it, end of 2Q? And if so, what gives you the confidence and at the end of the day that you're still able to put patient safety and patient priority first?

因此，我認為，先前的計劃是在 2025 年底之前完成所有中心的培訓。我認為您引用的是 25 年底的完全轉變。您現在談論的是在第二季末實現全面轉換嗎？如果是這樣，是什麼讓您有信心並且最終仍然能夠將患者安全和患者優先放在首位？

Got it. Thanks, John. I think from your first part of the question, it's more of a qualitative feel for patients delaying to get to Inspire V more than it is having specific quantities around that. And of the 1,500 centers, let's talk about the high-volume centers, if you count, word gets out is the limited market release centers, do cases and communicate that with their partners and with other centers and people become aware of it.

知道了。謝謝，約翰。我認為從問題的第一部分來看，對於延遲使用 Inspire V 的患者來說，這更多的是一種定性感受，而不是具體的數量。在這 1,500 個中心中，讓我們來談談那些處理量大的中心，如果你算上的話，就會知道那些有限的市場發布中心，處理案例，並與他們的合作夥伴和其他中心進行溝通，這樣人們就會意識到這一點。

Yes, people listened to our earnings calls, they do read your note and the other's notes on Inspire V and the pending launch. And I think that just continued to grow the awareness. And so qualitatively, we're really starting to hear a little bit more about that across the board without putting specific numbers to it. And going back to the previous question that you talked about in part two is, I mean, we're continuing to focus on the training of all the centers.

是的，人們聽了我們的財報電話會議，他們確實閱讀了您的筆記以及其他人關於 Inspire V 和即將推出的產品的筆記。我認為這只會不斷提高人們的認識。因此，從質量上講，我們確實開始聽到更多關於這方面的全面信息，儘管沒有具體的數字。回到您在第二部分中談到的上一個問題，我的意思是，我們將繼續關注所有中心的培訓。

And this month, we're going to do the full launch to make Inspire V available. That's not committing that we're going to have every center trained by the second quarter. But certainly, we're going to focus on the high quartile centers first to make sure that they're up and running with V, but we're going to make sure that we have full transition by the end of the year and being that we're able to do the strong launch of the full large right here in the May time frame, certainly gives us the opportunity to pull that full penetration up quite a bit. So we'll keep tracking that, and we'll continue to report back to you on that.

本月，我們將全面推出 Inspire V。這並不意味著我們會在第二季之前對所有中鋒進行訓練。但當然，我們將首先關注高四分位數中心，以確保它們能夠與 V 一起運行，但我們將確保在年底前完成全面過渡，並且我們能夠在 5 月份強勢推出全面產品，這無疑使我們有機會將全面滲透率提高很多。因此，我們會繼續追蹤此事，並將繼續向您報告。

Brett Fishbin, KeyBanc Capital Markets.

布雷特‧菲什賓 (Brett Fishbin)，KeyBanc 資本市場。

Just wanted to switch gears a little bit to the marketing strategy for Inspire V. It sounds like you're going to be stepping up the DTC spend a little bit ahead of the launch which makes sense? And really just curious like how you're thinking about changing the external messaging to potential patients, if you're going to be focusing on specifically some of the improvements to the procedure or if that's like you and the weeds for general consumption. Maybe just like a little bit more about how you're thinking about that?

我只是想稍微談談 Inspire V 的行銷策略。聽起來你會在產品發布前稍微增加 DTC 支出，這合理嗎？我真的很好奇，您是如何考慮改變向潛在患者傳達的外部信息，您是否會特別關注程序的某些改進，或者這是否像您和供一般消費的雜草一樣。也許只是想進一步了解您對此的看法？

Yes, I think we'll do a little bit of both. We'll continue with our own outreach programs that's very strong and be able to get patients' awareness and to get them to the website. Our website will talk about Inspire V, and we'll have to provide the necessary information to the patient so they understand the therapy going in. And so when they are able to make that appointment with their health care provider that they're coming in with knowledge V coming in with confidence in the therapy and understanding of the process overall.

是的，我想我們會兩者兼顧。我們將繼續推行我們自己的非常強大的外展計劃，並能夠提高患者的認識並讓他們訪問網站。我們的網站將討論 Inspire V，我們必須向患者提供必要的信息，以便他們了解正在進行的治療。因此，當他們能夠與醫療保健提供者預約時，他們就會帶著知識和對治療的信心來接受治療，並了解整個過程。

We will be doing individual communications with patients who have come to our website in the past, left our contact information and if there's new information coming off to please, let them know about the new information. So we will go back and reach back to all the patients that have previously come to Inspire. And that's a significant number of patients that have visited Inspire over the years and let them know that.

我們將與過去曾造訪我們網站並留下聯絡資訊的患者進行個人溝通，如果有新的訊息，我們會告知他們。因此，我們將回去聯繫所有先前來過 Inspire 的患者。多年來，有大量患者造訪過 Inspire 並告知他們這一點。

Yes, Inspire V is now available. It is in the full launch aspects of it. So it's going to be a multiple faceted marketing program. to be able to get that, get the word out even further.

是的，Inspire V 現已上市。它正處於全面啟動階段。所以這將是一個多方面的行銷計劃。為了能夠實現這一目標，我們將進一步傳播這一訊息。

Michael Polark, Wolfe Research.

邁克爾·波拉克，沃爾夫研究中心。

Two quick ones. How many Inspire V implants to date worldwide, if you said it, I missed it. I'm just curious for the evidence base, the size of it ahead of launch. And then -- with all of the sequential phasing discussion, I'm interested if you're willing to put a finer point on 3Q. I hear the 2Q guidance.

兩個簡單的。到目前為止，全球有多少 Inspire V 植入物？如果您說了，我錯過了。我只是好奇證據基礎以及發射前的證據規模。然後 - 通過所有連續階段的討論，我很想知道您是否願意對第三季度進行更詳細的說明。我聽到了第二季的指導。

If I look at the last two years, 31 has been up low single digits versus 2Q. 2Q sounds suppressed, should we compare our 3Q to 1Q and do it that way? Or what kind of progression growth-wise, what you expect? And I'm really getting to like how loaded the guide is into 4Q?

如果我回顧過去兩年，31 與第二季相比只上漲了個位數。2Q 聽起來被抑制了，我們應該將 3Q 與 1Q 進行比較並這樣做嗎？或者您期望在成長方面取得什麼樣的進展？我真的很喜歡 4Q 指南的內容嗎？

Sure, Mike. Let me tackle the first one, and we'll give you Rick for second one. First, we haven't really put out how many Inspire V's we've done. But we did early work prior to approval. We submitted that data to the FDA. And that's where we're able to collect devices or collect data with inspire IV patients and using external V with that -- to use those patients as their own comparison.

當然，麥克。讓我來解決第一個問題，然後我們會把第二個問題交給 Rick。首先，我們還沒有真正公佈我們已經生產了多少 Inspire V。但我們在獲得批准之前做了一些早期工作。我們將該數據提交給了 FDA。在那裡，我們能夠收集設備或收集來自激勵 IV 患者的數據，並使用外部 V - 將這些患者作為自己的比較對象。

So we have evidence going in that gave us confidence with the therapy, that, of course, with the qualification data, we have significant evidence from that standpoint. And now, of course, post approval with a lot of commercial implants both Singapore and through the limited release and we'll be putting a lot of that information together, and you'll see some of that come out during the upcoming Sleep meeting in Seattle in June.

因此，我們有證據讓我們對這種療法充滿信心，當然，有了資格數據，從這個角度來看，我們有重要的證據。當然，現在，許多商業植入物都已在新加坡和有限的市場獲得批准，我們將把這些資訊匯總在一起，您將在 6 月於西雅圖舉行的睡眠會議上看到其中一些資訊。

Yes. Regarding the second half of the year, Mike, Q4 is historically our strongest quarter. And I did talk a little bit earlier in the earlier responses that we expect even Q4 to be even stronger this year given the Q2 launch of Dynamics and how we expect utilization improvements to occur in the second half of the year.

是的。關於下半年，麥克，第四季是我們歷史上表現最強勁的一個季度。我在之前的回覆中確實提到過，考慮到 Dynamics 在第二季度的推出以及我們預計今年下半年利用率會有所提高，我們預計今年第四季度的表現會更加強勁。

Brett Gasaway, Leerink Partners.

Leerink Partners 的 Brett Gasaway。

This is Brett on for Mike. Congrats on a good quarter. So the inventory days, obviously, we've spoken about this at length on this call, but it increased by almost a full quarter's worth of inventory. So I just want to see how you're thinking about the progression of gross margin over the course of the year as this Inspire V mix increases?

我是布雷特，代替麥克。恭喜本季取得良好業績。因此，庫存天數顯然我們已經在這次電話會議上詳細討論過這個問題，但它增加了近一個季度的庫存。所以我只是想看看，隨著 Inspire V 組合的增加，您如何看待今年毛利率的進展？

Yes. We reiterated our gross margin guidance of 84% to 86%. We did increase that this year compared to a year ago. And we have stated that without price change that our gross margin is accretive with Inspire V. And we're going to continue to manufacture Inspire IV throughout 2025 because we're going to continue to sell it internationally as we await approval and we want to make sure we have sufficient Inspire IV inventory on hand until Inspire V is approved outside the US.

是的。我們重申 84% 至 86% 的毛利率預期。與去年相比，今年我們確實增加了這個數字。我們已經聲明，在價格不變的情況下，我們的毛利率會隨著 Inspire V 而增加。我們將在 2025 年繼續生產 Inspire IV，因為在等待批准期間，我們將繼續在國際上銷售它，並且我們希望確保在 Inspire V 在美國以外獲得批准之前，我們手頭上有足夠的 Inspire IV 庫存。

And also keep in mind that a lot of the components for Inspire v can be used -- or for Inspire IV can be used for Inspire V as well. So we're going to continue to build sufficient inventory, and we're excited about the launch, and we're in a good spot for that this month.

還要記住，Inspire v 的許多組件都可以用於 Inspire IV，或者也可以用於 Inspire V。因此，我們將繼續建立足夠的庫存，我們對此次發布感到非常興奮，本月我們處於有利位置。

Understood. That's helpful. And if I can get one follow-up, just on the OUS side. I don't know if we touched on it too much. But obviously, you had a tough comp, and it was down sequentially. So was there any FX that was impacting that?

明白了。這很有幫助。如果我可以得到一個後續訊息，就在 OUS 方面。我不知道我們是否談論得太多。但顯然，你們的競爭很激烈，而且情況連續下滑。那麼是否有任何 FX 對此產生影響？

No real FX in the first quarter, but we are seeing some in the second quarter.

第一季沒有真正的外匯，但我們在第二季度看到了一些。

This concludes the Q&A session for the conference. I'd now like to turn the call back to Tim for any closing remarks.

會議的問答環節到此結束。現在我想把電話轉回給提姆，請他做最後發言。

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 team's commitment to patients remains unmatched and is the most important element to our success.

感謝大家今天參加電話會議。像往常一樣，我感謝不斷成長的 Inspire 員工團隊，感謝他們的熱情、辛勤工作和持續的動力，為患者帶來了成功和一致的治療效果。團隊對患者的承諾無與倫比，這是我們成功的最重要因素。

I wish to thank all of our employees as well as the health care teams for the continued efforts as we remain focused on further expanding our business in the US, Europe and in Asia. For all of you on the call, we appreciate your continued interest and support of Inspire and look forward to providing you with further updates in the months ahead.

我要感謝我們所有的員工以及醫療團隊的持續努力，我們將繼續專注於進一步擴大我們在美國、歐洲和亞洲的業務。對於電話會議中的所有人，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。

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

今天的電話會議到此結束。您現在可以斷開連線。