Senseonics Holdings Inc (SENS) 2025 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good day everyone and welcome to today's Senseonics 3rd Quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer session, and please note today's call will be recorded.

    大家好,歡迎參加今天的Senseonics 2025年第三季財報電話會議。目前,所有參與者均處於唯讀模式。稍後您將有機會在問答環節提問,請注意,今天的通話將被錄音。

  • I'll be standing by should you require any assistance, and it is now my pleasure to turn the conference over to Mr. Jeremy Pfeffer from Life Sci Advisors. Mr. Pfeffer, please go ahead, sir.

    如果您需要任何幫助,我將隨時待命。現在,我很高興將會議交給來自 Life Sci Advisors 的 Jeremy Pfeffer 先生。佩弗先生,請繼續。

  • Jeremy Feffer - Managing Director

    Jeremy Feffer - Managing Director

  • Thank you. This is Jeremy Pfeffer from LifeSci Advisors. Before we begin today, let me remind you that the company's remarks include forward-looking statements. These statements reflect management's expectations about future events, operating plans, regulatory matters, product enhancements, company performance, and other matters, and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under risk factors and elsewhere in our annual report on Form 10K for the year ended December 31, 2024, and our 10Qs and our other reports filed with the SEC.

    謝謝。這位是來自 LifeSci Advisors 的 Jeremy Pfeffer。在今天會議開始之前,請允許我提醒各位,該公司的聲明中包含前瞻性陳述。這些聲明反映了管理層對未來事件、營運計劃、監管事項、產品改進、公司業績及其他事項的預期,並且僅代表截至本聲明發布之日的情況。這些前瞻性陳述涉及許多風險和不確定性。可能導致實際結果與任何前瞻性聲明中明示或暗示的結果存在重大差異的因素清單,詳見截至 2024 年 12 月 31 日止年度的 10-K 表格年度報告以及我們向美國證券交易委員會提交的 10-Q 表格和其他報告中的“風險因素”部分及其他部分。

  • These documents are available in the investor relations section of our website at www.senseionics.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason, except as required by law.

    這些文件可在我們網站 www.senseionics.com 的投資者關係欄位中查閱。除法律要求外,我們不承擔因任何原因公開更新或修訂這些前瞻性聲明的義務。

  • Joining me today from Senseonics are Tim Goodnow, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. I'll now turn the call over to Tim.

    今天與我一同出席的有 Senseonics 公司的總裁兼執行長 Tim Goodnow 和財務長 Rick Sullivan。現在我將把電話交給提姆。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Thanks Jeremy, and I appreciate everyone's time joining us today. As mentioned in our earnings release earlier today, the 3rd Quarter was truly exceptional for Senseonics. We're pleased to see the growth in interest and adoption of Eversense E3, supported by Senseonics DTC campaign and sales efforts. Our 3rd Quarter revenue grew by 90% from Q3 last year. During the quarter, we also executed a memorandum of understanding with the Ascensia Diabetes Care to reassume control of Eversense commercialization.

    謝謝傑里米,也感謝今天所有抽出時間參加我們節目的朋友。正如我們在今天稍早發布的財報中所提到的,Senseonics 第三季的業績確實非常出色。我們很高興看到人們對 Eversense E3 的興趣和接受度不斷提高,這得益於 Senseonics 的 DTC 行銷活動和銷售努力。我們第三季的營收比去年第三季成長了90%。本季度,我們也與 Ascensia Diabetes Care 簽署了一份諒解備忘錄,以重新掌控 Eversense 的商業化。

  • We're excited about the upcoming change and seeing it as enabling us to control the strategy and investments into building Eversense. Through this change, commercialization efforts will continue to be led by Brian Hansen, who has been appointed as Chief Commercial Officer of Senseonics.

    我們對即將到來的變化感到興奮,並認為這將使我們能夠控制建立 Eversense 的策略和投資。透過這項變化,商業化工作將繼續由 Brian Hansen 領導,他已被任命為 Senseonics 的首席商務長。

  • I'll provide some additional details on the progress we've made with the Ascensia CGM division in a few minutes. But first, I'll share some additional accomplishments from the 3rd Quarter. This time last year we committed to doubling the number of patients on Eversense in 2025, and we are on track to achieve that goal. The 90% year over year revenue growth in the third quarter was driven by 160% growth in new patient shipments for the quarter over the prior year period. These growth numbers are a testament to the effectiveness of our direct-to-consumer marketing which we continue to invest in, driving demand with patients asking their physicians to prescribe the world's only 365-day continuous glucose monitor.

    稍後我將提供更多關於我們與 Ascensia CGM 部門合作取得進展的細節。但首先,我想分享一下第三季取得的其他一些成就。去年這個時候,我們承諾到 2025 年將 Eversense 的患者人數翻一番,我們正朝著實現這一目標穩步前進。第三季營收年增 90%,主要得益於當季新增病患出貨量較上年同期成長 160%。這些成長數字證明了我們直接面向消費者的行銷策略的有效性,我們將繼續投資於此,推動需求成長,患者要求他們的醫生開立世界上唯一的 365 天連續血糖監測儀。

  • During the quarter, we made meaningful DTC investments to augment Ascensia's spend, leading to an increase in patient leads through our digital campaigns of 300% year-over-year and 85% sequentially. Approximately 60% of our new patients in Q3 originated from our DTC advertising and 40% from HCP referrals, a historically larger portion now coming from DTC due to the scaling of our direct-to-consumer strategy and investments.

    本季度,我們對 DTC 進行了重要的投資,以增加 Ascensia 的支出,從而使我們的數位行銷活動帶來的患者線索同比增長 300%,環比增長 85%。第三季度,我們約 60% 的新患者來自我們的 DTC 廣告,40% 來自 HCP 轉診,由於我們直接面向消費者的策略和投資規模擴大,現在來自 DTC 的比例比以往更大。

  • We will continue to invest in direct consumer marketing primarily through social media. Our increased spending has directly contributed to our increased number of leads, prescribed referrals, and prescriptions written. In the 3rd Quarter, we continue to break records for the newest patient starts, with September being our highest number of new patients starts in a month and Q3 being our highest quarter in the company's history.

    我們將繼續加大對直接消費者行銷的投入,主要透過社群媒體進行。我們增加的支出直接促成了我們銷售線索數量、處方轉診數量和處方數量的增加。第三季度,我們持續打破新患者開診數量的紀錄,9 月的新患者開診數量達到單月最高,第三季也創下公司史上的最高季紀錄。

  • New insertions increased nearly 150% year over year. And more than 50% sequentially. As a result, our installed base grew over 150% year over year and nearly 40% sequentially, reflecting accelerating adoption of Eversense 365 among both patients and providers. As expected, reorder volumes were minimal for the quarter following the one-time transition to the 365-day sensor. This means that essentially all of those patients inserted with Eversense in the quarter were new users. In Q4 with the first Eversense 365 coming up for reinsertion. Reorders will make a more meaningful contribution to sales.

    新增植入量年增近150%。環比增長超過 50%。因此,我們的安裝基礎年增率超過 150%,較上季成長近 40%,反映出 Eversense 365 在病患和醫療服務提供者中的普及速度加快。正如預期的那樣,在一次性過渡到 365 天感測器之後的那個季度,重新訂購量非常少。這意味著本季接受 Eversense 置入的患者基本上都是新用戶。第四季度,首批 Eversense 365 將進行重新植入。重複訂購將對銷售做出更有意義的貢獻。

  • Our DTC channel continues to expand and deepen engagement as well. The number of providers actively prescribing Eversense grew more than 55% year over year, reflecting broadening awareness and confidence in the Eversense 365 system.

    我們的DTC管道也不斷拓展和深化用戶互動。積極開立 Eversense 處方的醫療服務提供者數量年增超過 55%,反映出人們對 Eversense 365 系統的認識和信心不斷增強。

  • Importantly, we added 75 new trained inserters in the quarter, 140% more than the same time last year. The capacity of our inserter network continues to expand, ensuring continued access and scalability as demand accelerates. Many of these new patients that we added are now supported by our Eversense Care direct insertion business, which provides greater access to Eversense through our network of providers. Eversense Care delivered a standout quarter, advancing its role as a key strategic driver of insertion capacity, access, and standardized patient experience. While still early in its development, Eversense Care now represents approximately 25% of all insertions nationwide.

    重要的是,本季我們新增了 75 位受過訓練的插頁員,比去年同期成長了 140%。我們的插入器網路容量持續擴大,確保隨著需求的加速成長,使用者能夠持續存取產品並實現可擴展性。我們新增的許多患者現在都透過我們的 Eversense Care 直接植入業務獲得支持,該業務透過我們的醫療服務提供者網路提供更多獲得 Eversense 的機會。Eversense Care 在本季度表現出色,進一步鞏固了其作為植入能力、准入和標準化患者體驗的關鍵策略驅動者的地位。儘管 Eversense Care 仍處於發展初期,但目前已佔全國所有植入量的約 25%。

  • And we continue to expand Eversense Care's capacity by adding significantly more inserters in the network in Q3. Eversense Care is a central enabler of nationwide access and adoption. Patients love the convenience and affordability, and prescribers appreciate having a trusted certified Eversense inserter they can refer patients to. We will continue to expand Eversense Care’s capacity in Q4 and beyond as it becomes an increasingly important enabler of Eversense growth. In new product development, our CE Mark application for Eversense 365 in Europe was submitted in February, and while in the final stages of review, we continue to expect to receive the approval before the end of 2025. Approval in Europe is anticipated to support additional growth beginning with our planned launch in the first half of 2026, now utilizing our own Senseonics European sales force after the transition away from the Ascensia Diabetes Care.

    第三季度,我們將繼續擴大 Eversense Care 的容量,在網路中增加更多的插入器。Eversense Care 是全國範圍內獲取和推廣服務的核心推動力量。患者喜歡它的便利性和經濟性,而處方醫生也樂於見到值得信賴的、經過認證的 Eversense 植入器,可以將其推薦給患者。我們將在第四季及以後繼續擴大 Eversense Care 的產能,因為它正成為 Eversense 成長日益重要的推動因素。在新產品開發方面,我們於 2 月提交了 Eversense 365 在歐洲的 CE 標誌申請,雖然目前處於審查的最後階段,但我們仍然預計在 2025 年底之前獲得批准。預計在歐洲獲得批准將支援進一步成長,我們計劃於 2026 年上半年推出該產品,在從 Ascensia Diabetes Care 過渡後,現在將利用我們自己的 Senseonics 歐洲銷售團隊。

  • Prior to the European launch of Eversense 365, we expect to work with Ascensia through transition service agreements while we set up our own infrastructure to support a smooth transfer of some employees, the hiring of new CGM dedicated sales reps, and transferring current customer contracts and tender agreements. In contrast with the US commercial integration, which we expect to be in place by January 1, the European transition will be taking place in the first half of 2026 with support from Ascensia. We are currently finalizing these arrangements with Ascensia and planning this transition in a collaborative process. We've made good progress since the announcement in early September. Nearly all of the employees from Ascensia’s US CGM business have elected to join the Senseonics team for the planned transition on January 1, including Brian Hansen’s leadership team. The European CGM employees are expected to transition over later in the 1 quarter. The sales operations team has been extremely busy getting our CRM system up and running, and many of our distribution agreements between the distributors and Senseonics are already in place or in the process of being transitioned. We appreciate the cooperation between Senseonics and Ascensia teams who are working hard to ensure that we get this right for the patients and the providers. I'm pleased with the execution that's taken place over the past 60 days to bring Ascensia’s CGM business into Senseonics.

    在 Eversense 365 於歐洲推出之前,我們預計將透過過渡服務協議與 Ascensia 合作,同時建立我們自己的基礎設施,以支援部分員工的順利轉移、招募新的 CGM 專屬銷售代表以及轉移現有客戶合約和投標協議。與我們預計於 1 月 1 日完成的美國商業一體化相比,歐洲的過渡將在 2026 年上半年進行,並得到 Ascensia 的支持。我們目前正在與 Ascensia 敲定這些安排,並透過合作的方式規劃這項過渡。自9月初發佈公告以來,我們取得了良好進展。Ascensia 美國 CGM 業務的幾乎所有員工都選擇加入 Senseonics 團隊,以進行 1 月 1 日的計劃過渡,其中包括 Brian Hansen 的領導團隊。歐洲 CGM 員工預計將在第一季稍後完成過渡。銷售營運團隊一直非常忙於啟動和運行我們的客戶關係管理系統,我們與經銷商和 Senseonics 之間的許多分銷協議已經到位或正在過渡過程中。我們感謝 Senseonics 和 Ascensia 團隊的合作,他們正努力確保我們為患者和醫療服務提供者做好這件事。我對過去 60 天將 Ascensia 的 CGM 業務併入 Senseonics 的執行情況感到滿意。

  • Our partner SOOIL is working towards expanding its launch of the Twiist insulin delivery system and to include compatibility with Eversense 365, representing another top-line growth driver for us in 2026. As a first pump integration, we're excited for the opportunity to be part of the closed loop system with SOOIL's Twiist pump making insulin delivery decisions based on the data received from Eversense. We expect this closed loop system to allow patients to forget about glucose monitoring for an entire year, as their Eversense 365 communicates directly with Twiist for real-time adjustments in insulin delivery. Beyond SOOIL, we hope to make additional announcements on insulin pump integrations in the coming quarters. In addition to the integration work, our R&D team remains focused on delivering our seminal pipeline of products, Gemini and Freedom, with the IDE for Gemini on track to be submitted in the 4th quarter and the US approval still planned for late 2026. We expect to file the IDE for Freedom in the second half of next year with a commercial launch of our truly invisible transmitter-less 365-day CGM targeted by early 2028.

    我們的合作夥伴 SOOIL 正在努力擴大其 Twiist 胰島素輸送系統的上市規模,並使其與 Eversense 365 相容,這將為我們在 2026 年帶來另一個營收成長動力。作為首個幫浦整合項目,我們很高興有機會與 SOOIL 的 Twiist 幫浦組成閉環系統,該系統根據從 Eversense 接收的數據做出胰島素輸送決策。我們預計,這種閉環系統可以讓患者一整年無需監測血糖,因為他們的 Eversense 365 可以直接與 Twiist 通信,即時調整胰島素輸送。除了 SOOIL 之外,我們希望在接下來的幾個季度發布更多關於胰島素幫浦整合的公告。除了整合工作之外,我們的研發團隊仍專注於交付我們具有里程碑意義的產品線 Gemini 和 Freedom,Gemini 的 IDE 預計將於第四季度提交,美國批准仍計劃於 2026 年底進行。我們預計將於明年下半年提交 Freedom 的 IDE 申請,並計劃於 2028 年初正式推出我們真正隱形、無發射器的 365 天 CGM。

  • I'd also like to highlight the margin improvements that Rick will speak to. We are currently seeing meaningful improvements from the Eversense 365 product and expect to see even more as a result of the commercial integration. Based on what we've seen in the first three quarters of 2025, we are on track to end with gross profit margins now north of 40% compared to 25% at the end of 2024 based on the benefits and performance of Eversense 365. And we expect our transition with Ascensia to further positively impact our margins. As noted, when the deal was announced, we currently project that our gross margin would grow to roughly 50% in 2026 and reach approximately 70% at scale for the unified business.

    我還想重點介紹一下里克將要談到的利潤率提升方面的問題。我們目前已經看到 Eversense 365 產品帶來了顯著的改進,並期待隨著商業整合的完成,看到更多改進。根據我們在 2025 年前三個季度所看到的,基於 Eversense 365 的效益和表現,我們預計將實現毛利率超過 40%,而 2024 年底的毛利率為 25%。我們預計與 Ascensia 的合併將進一步對我們的利潤率產生積極影響。如前所述,在宣布該交易時,我們預計到 2026 年,我們的毛利率將增長到大約 50%,並且在統一業務規模擴大後將達到約 70%。

  • Hopefully this update on our growth drivers and a strong performance during the 1 year of the Eversense 365 launch gives you a good sense of where we're headed. To continue to drive shareholder value and meet the needs of our patients and providers, we remain committed to expanding access to our unique system and continuing to advance our technology to simplify glucose testing for people with diabetes.

    希望透過此次關於我們成長動力和Eversense 365發布第一年強勁表現的最新信息,能讓您更了解我們的發展方向。為了持續提升股東價值並滿足患者和醫療服務提供者的需求,我們將繼續致力於擴大我們獨特系統的使用範圍,並不斷推進我們的技術,以簡化糖尿病患者的血糖檢測。

  • I'll now turn the call over to Rick to walk through the Q3 financials, highlighting revenue growth, margin improvement, cost reduction, and steady progress on execution.

    現在我將把電話交給里克,讓他詳細介紹第三季度的財務狀況,重點關注收入成長、利潤率提高、成本降低以及執行方面的穩定進展。

  • Rick Sullivan - Chief Financial Officer

    Rick Sullivan - Chief Financial Officer

  • Thank you, Tim, and thanks to everyone joining us this afternoon.

    謝謝你,提姆,也謝謝今天下午所有到場的各位。

  • First of all, this has been an extremely busy quarter for Senseonics, and I'm grateful for all the team has achieved this quarter. Since announcing our plans to reassume CGM commercial operations from Ascensia Diabetes Care, we've made enhancements to the CRM system, expanded our ERP system. Plan the transition of most of the necessary contracts with US distributors and of offers accepted from almost all of the US employees joining Senseonics from Ascensia. We continue to invest in DTC advertising and as we've said previously, we plan to continue this spend for the foreseeable future. This investment has been extremely helpful in driving awareness and adoption, as evidenced by our strong top-line revenue growth. As you may have seen, with support from our shareholders, we executed a reverse stock split. This was an important step for the company as we had the opportunity to speak with many investors that were interested in the story but were unable to invest in a sub - $1 stock. The reverse split enables access to new large investors and significantly simplifies our cap table.

    首先,Senseonics 本季非常忙碌,我感謝團隊在本季的所有成就。自從我們宣布計劃從 Ascensia Diabetes Care 重新接管 CGM 商業運營以來,我們對 CRM 系統進行了改進,並擴展了 ERP 系統。該計劃將與美國分銷商的大部分必要合約以及幾乎所有從 Ascensia 加入 Senseonics 的美國員工接受的聘用合約進行過渡。我們將繼續投資於直接面向消費者的廣告,正如我們之前所說,我們計劃在可預見的未來繼續這項支出。這項投資對提高品牌知名度和推廣應用起到了極大的幫助,我們強勁的營收成長證明了這一點。如您所見,在股東的支持下,我們進行了反向股票分割。這對公司來說是一個重要的里程碑,因為我們有機會與許多對公司發展故事感興趣但無法投資股價低於 1 美元的投資者進行交流。反向分割使我們能夠吸引新的大型投資者,並大幅簡化我們的股權結構表。

  • Following the split, we currently have approximately 41 million shares of common stock outstanding. Now transitioning to the quarterly results—in the third quarter of 2025, net revenue grew 90% to 8.1 million compared to 4.3 million in the prior year period on the strength of top-line Eversense 365 U.S. revenue. US revenue for the third quarter was 6.4 million, and revenue outside the US was 1.7 million. Also, as a quick reminder regarding revenue recognition, through our collaboration agreement with Ascensia, we recognize a portion of the Eversense revenue under our revenue sharing agreement. With the expected transition from Ascensia distribution, we anticipate that we would recognize 100% of revenues due to elimination of the revenue share. Without the collaboration, reported revenue in Q3 would be nearly 20% higher based on the current channel mix, and we expect a similar channel mix going forward. We also sell products through an office consignment program which continues to grow—now making up over 50% of our global revenue in Q3. In this channel, we recognize revenue at the time of procedure and at the same time record a commission expense to sales and marketing expenses based on the current revenue sharing percentage for Ascensus's commercial support which we also anticipate being eliminated on January 1.

    股票分割後,我們目前約有 4,100 萬股普通股流通在外。現在過渡到季度業績——2025 年第三季度,淨收入增長 90%,達到 810 萬美元,而去年同期為 430 萬美元,這主要得益於 Eversense 365 美國業務的強勁收入。第三季美國營收為 640 萬美元,美國以外地區營收為 170 萬美元。另外,關於收入確認,需要快速提醒一下,根據我們與 Ascensia 的合作協議,我們將根據收入分成協議確認一部分 Eversense 收入。隨著從 Ascensia 分銷管道的過渡,我們預計由於收入分成的取消,我們將確認 100% 的收入。如果沒有此次合作,根據目前的通路組合,第三季報告的營收將成長近 20%,我們預計未來通路組合也將維持類似水準。我們也透過辦公室寄售計畫銷售產品,該計畫持續成長——目前在第三季占我們全球收入的 50% 以上。在這個管道中,我們在手術時確認收入,同時根據 Ascensus 商業支持的當前收入分成比例,將佣金支出計入銷售和行銷費用,我們也預計該佣金支出將在 1 月 1 日被取消。

  • In Q3 2025, gross profit was $3.5 million, an increase of $7.5 million from the prior year period. This increase in gross profit was primarily driven by the one-time charges incurred in the prior year as a result of the transition from Eversense E3 to Eversense 365, as well as more favorable margins on the 365-day product sales.Research and development expenses in Q3 2025 were $7.8 million, a decrease of $2.7 million compared to the prior year period. The decrease was primarily due to the completion of the Eversense 365 clinical trials and development efforts, as well as a reduction in headcount. Third quarter 2025, selling general and administrative expenses were $15.3 million, an increase of $7 million compared to $8.3 million in the prior year period, primarily driven by higher selling and marketing personnel costs, promotional expenses mainly due to the DTC investments, sales commission expenses to Ascensia as we, increased consignment sales, and other general and administrative costs. Net loss was $19.5 million or a $0.43 loss per share in the third quarter of 2025 compared to a net loss of $24 million or a $0.77 loss per share in the third quarter of 2024. Net loss decreased by 4.5 million, primarily due to improved gross margins of Eversense 365 sales in the United States and the overall reduction in research and development costs. We now expect full year 2025 global net revenue to be approximately $35 million as we progress the launch of Eversense 365 in the US.

    2025 年第三季度,毛利為 350 萬美元,比去年同期增加了 750 萬美元。毛利的成長主要得益於前一年因從 Eversense E3 過渡到 Eversense 365 而產生的一次性費用,以及 365 天產品銷售利潤率的提高。 2025 年第三季的研發費用為 780 萬美元,比去年同期減少了 270 萬美元。下降的主要原因是 Eversense 365 臨床試驗和開發工作的完成,以及人員數量的減少。2025 年第三季度,銷售一般及行政費用為 1530 萬美元,比上年同期的 830 萬美元增加了 700 萬美元,主要原因是銷售和營銷人員成本增加、促銷費用(主要由於 DTC 投資)、支付給 Ascensia 的銷售佣金、寄售銷售額增加以及其他一般及行政費用。2025 年第三季淨虧損 1,950 萬美元,即每股虧損 0.43 美元,而 2024 年第三季淨虧損 2,400 萬美元,即每股虧損 0.77 美元。淨虧損減少了 450 萬美元,主要原因是 Eversense 365 在美國的銷售毛利率提高以及研發成本的整體降低。隨著我們在美國推進 Eversense 365 的推出,我們現在預計 2025 年全年全球淨收入約為 3500 萬美元。

  • This financial outlook takes into consideration several factors. Including the timeline for regulatory approval and the planned commercial launch of Eversense 365 outside the United States, plans with respect to spending on the U.S DTC marketing campaigns to generate leads, continued progress in our launch activities, reinsertion and pricing dynamics with the shift from a 6- to 12-month product, the status of other sales and marketing initiatives. And importantly, this excludes any one-time accounting adjustments related to the technical review of the final Ascensia agreement, including the transition of inventory back to Senseonics during the business integration. The full year 2025 financial outlook assumes approximately doubling the global patient base in 2025 compared to 2024. We achieved our target of approximately one-third of planned annual revenue in the first half of the year, with the remaining two-thirds of revenue expected in the second half because of the steady increase in patients and the seasonality of program discounts and patient deductibles. We expect the majority of revenue in the 4th quarter due to the continued momentum and new patient starts and importantly reorders from our first U.S. Eversense 365 patients as we pass the first anniversary of our Eversense 365 launch. Excluding accounting adjustments and one-time benefits that have a positive impact on gross profit margins, we continue to see favorability due to our sales channel mix and the execution of our manufacturing and supply chain teams. We are continuing to monitor the impact of tariffs and currently expect that we'll be able to mitigate much of the negative impacts.

    這份財務展望考慮了多種因素。包括監管部門批准的時間表和 Eversense 365 在美國以外地區的計劃商業發布,關於在美國開展 DTC 營銷活動以獲取潛在客戶的支出計劃,我們發布活動的持續進展,從 6 個月產品到 12 個月產品的重新插入和定價動態,以及其他銷售和營銷舉措的現狀。更重要的是,這不包括與最終 Ascensia 協議的技術審查相關的任何一次性會計調整,包括在業務整合期間將庫存轉移回 Senseonics。2025 年全年財務展望假設 2025 年全球病患數量將比 2024 年翻倍。今年上半年,我們實現了計劃年度收入的三分之一左右的目標,預計下半年將實現剩餘的三分之二收入,這得益於患者數量的穩步增長以及項目折扣和患者自付額的季節性變化。由於持續的成長勢頭和新患者的加入,以及更重要的是,隨著我們 Eversense 365 上市一周年,首批美國 Eversense 365 患者的複購訂單,我們預計第四季度將獲得大部分收入。除會計調整和對毛利率產生積極影響的一次性收益外,我們繼續看到有利因素,這主要歸功於我們的銷售管道組合以及我們製造和供應鏈團隊的執行力。我們正在持續關注關稅的影響,目前預計將減輕大部分負面影響。

  • Taking into consideration our margin performance to date, the anticipated continued favorability and excluding favorable accounting adjustments, we now expect full year gross profit margins to be between 35% and 40%. As Tim mentioned, we are excited about our margin expansion next year as a result of bringing the commercialization of Eversense back to Senseonics and expect gross profit margins north of 50% next year growing to approximately 70% or more with scale. It is still too early to provide guidance for 2026 at this time as we execute the transition of the commercial team and work closely with them on our financial plans considering balanced investments in DTC, Salesforce expansion, other commercial programs, inventory balances across the various channels, and inventory transitioning back to Sensionics depending on the final agreement with Ascensia. We intend to provide initial 2026 guidance in early January. We continue to expect cash utilization in 2025 to be approximately $60 million largely as a result of tight cash management while meaningfully contributing to the DTC spend. Our September 30thcash, restricted cash, and cash equivalent balance was $111.3 million and debt and accrued interest was $35.3 million.

    考慮到我們迄今為止的利潤率表現、預期的持續有利因素,並且不考慮有利的會計調整,我們現在預計全年毛利率將在 35% 至 40% 之間。正如 Tim 所提到的,由於 Eversense 的商業化回歸 Senseonics,我們對明年利潤率的擴張感到興奮,預計明年毛利率將超過 50%,隨著規模的擴大,毛利率將增長到 70% 或更高。目前為 2026 年提供指導還為時過早,因為我們正在執行商業團隊的過渡,並與他們密切合作制定財務計劃,考慮在 DTC、Salesforce 擴展、其他商業計劃、各個渠道的庫存餘額以及根據與 Ascensia 的最終協議將庫存轉移回 Sensionics 等方面的平衡投資。我們計劃在1月初發布2026年初步業績指引。我們繼續預期 2025 年現金使用量約為 6,000 萬美元,這主要是由於嚴格的現金管理,同時也將對 DTC 支出做出重大貢獻。截至9月30日,我們的現金、受限現金及現金等價物餘額為1.113億美元,債務及應計利息為3,530萬美元。

  • With that, I'll turn it back to Tim.

    這樣,我就把麥克風交還給提姆了。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Thanks, Rick. These are exciting times for Eversense and the accelerating growth of our revolutionary 365-day product. We are seeing significant new patient additions and top-line growth due to expanding awareness and adoption of Eversense 365 in the U.S. DTC investments are paying dividends as more people become aware of the compelling benefits of our product. Our margins are improving. The sales force is gaining traction, rep productivity is improving, and we are now entering a cycle where renewals will contribute to the sales as the initial 365 patients restart the clock on 365 days of carefree continuous glucose monitoring. The Gemini and Freedom programs are advancing, and our European approval is on track, as is our compatibility with SOOIL’s Twiist insulin pump. We are making good progress in executing the transition to resume control of Eversense commercialization and look forward to our full independent direction in a couple of months. Overall, this was a record setting quarter highlighted by all-time highs in new patient shipments, insertions, and installed base. A hybrid BTC and provider model amplified by Eversense Care’s growing network continues to accelerate awareness, access, confidence, and growth in Eversense 365 and positioning us for sustained growth heading into 2026.

    謝謝你,里克。對於 Eversense 而言,這是一個令人興奮的時刻,我們革命性的 365 天產品正在加速成長。由於 Eversense 365 在美國的知名度和普及程度不斷提高,我們看到新增患者數量和營收大幅成長。隨著越來越多的人意識到我們產品的顯著優勢,直接面向消費者的投資正在獲得回報。我們的利潤率正在提高。銷售團隊正在取得進展,銷售代表的生產力正在提高,我們現在正進入一個週期,續約將有助於銷售,因為最初的 365 名患者將重新開始 365 天的無憂連續血糖監測。Gemini 和 Freedom 專案正在推進,我們的歐洲審批也進展順利,與 SOOIL 的 Twiist 胰島素幫浦的兼容性也得到了驗證。我們在恢復對Eversense商業化控制權的過渡工作中取得了良好進展,並期待在幾個月內實現完全獨立的發展方向。整體而言,本季創下歷史新高,新患者出院量、植入量和安裝基數均達到歷史最高水準。混合型 BTC 和提供者模式,加上 Eversense Care 不斷增長的網絡,持續加速人們對 Eversense 365 的認知、獲取、信心和成長,並使我們為 2026 年的持續成長奠定了基礎。

  • Thank you all for joining us today and for your continued interest. With that, I'll now turn the call over to the operator to answer any questions that you may have. Operator let's go ahead and open up the call for questions.

    感謝各位今天蒞臨,也感謝你們一直以來的關注。接下來,我將把電話轉交給接線員,由他來回答您可能有的任何問題。接線員,我們現在開始接受提問。

  • Operator

    Operator

  • [Operator instruction]

    [操作說明]

  • Matt Miksis of Barclays. Matt, please go ahead.

    巴克萊銀行的馬特‧米克西斯。馬特,請繼續。

  • Matt Miksic - Equity Research Analyst

    Matt Miksic - Equity Research Analyst

  • Hey, thanks so much for taking the questions and congrats on all the great progress. Wanted to follow-up on, some of the growth opportunities that you've shown in DTC.

    嘿,非常感謝你回答這些問題,也祝賀你取得的巨大進步。我想就您在DTC領域展示的一些成長機會進行後續探討。

  • And then I have 11 other quick follow-ups. So just on the new patient implants, which made up the majority here in Q3, can you talk a little bit about what you're learning, if at all, about the, where these folks are coming from — in terms of new, in terms of, tired of externally worn sensors. Just some color would be super interesting and helpful to understand, where the demand is coming from, and as I mentioned, I have one quick follow-up.

    然後我還有 11 個後續問題需要快速解答。所以,就第三季度佔大多數的新患者植入而言,您能否談談您了解到的情況,以及這些患者來自哪裡——他們厭倦了外部佩戴的傳感器。如果能提供一些具體信息,將會非常有趣,也很有助於了解需求的來源。正如我之前提到的,我還有一個後續問題。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • To appreciate the time as well. So overall, geographically, it's a very nice distribution as we are certainly focused on obviously the highest prescribing, best reimbursement, highest insulin utilization. So, you know no one locale I would say is driving it, but we are definitely seeing—and we gave a hint to it—we are seeing a significant growth in the number of switches. So, as you may recall we typically saw about 75% were folks that were coming from existing CGM and now with this increased DTC we're seeing that right around at 90%. So, we clearly are reaching out to the folks that are currently on CGM. I would say of those switchers it's probably 60–65% from Dexcom and 35-40% coming from Libre, so good distribution there. Typical demographics, we're still seeing a nice utilization and interest in the in the Medicare space with probably two-thirds of it still coming from commercial pay so. Hope that helps.

    也要珍惜這段時光。因此,從地理分佈來看,總體而言,這是一個非常好的分佈,因為我們顯然專注於處方量最高、報銷額最高、胰島素使用率最高的地區。所以,雖然我不能說是某個特定地區在推動這一趨勢,但我們確實看到——而且我們已經暗示過——交換機的數量正在顯著增長。所以,您可能還記得,我們​​通常看到大約 75% 的人來自現有的 CGM,而現在隨著 DTC 的增加,我們看到這個比例達到了 90% 左右。所以,我們顯然是在聯繫目前正在使用 CGM 的人群。我認為在這些轉換者中,大概有 60-65% 來自 Dexcom,35-40% 來自 Libre,所以分佈情況不錯。從典型的人口統計數據來看,我們仍然看到醫療保險領域有良好的使用率和興趣,其中可能三分之二仍然來自商業支付。希望對您有幫助。

  • Matt Miksic - Equity Research Analyst

    Matt Miksic - Equity Research Analyst

  • Yeah, no, absolutely, and it's just a follow-up on the integration with. With Twist, maybe if you could talk a little bit about how that ramps— I know, Twist and Sequel are now kind of ramping up their launch. Maybe give us a sense of when you think and expect that that'll start to make a note, a measurable contribution that that we can start talking about recognizing in the numbers. Thanks again.

    是的,沒錯,這只是對整合的後續跟進。關於 Twist,也許你可以談談它的加速器是如何運作的……我知道,Twist 和 Sequel 現在正在加速它們的發布。或許您可以告訴我們,您認為和預期何時才能開始產生顯著影響,產生可衡量的貢獻,以便我們開始討論如何從數據中體現出來。再次感謝。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah, we are excited about that opportunity in 2026, they are still executing on some of their early launch activities. So our expectation at this point is that our first patients will go on early in the first quarter and that we would ramp from there. We've got a number of our large sites that are very interested.

    是的,我們對 2026 年的這個機會感到興奮,他們仍在執行一些早期的啟動活動。因此,我們目前的預期是,我們的第一批患者將在第一季初入院,然後我們將逐步擴大規模。我們有很多大型站點對此非常感興趣。

  • But there does need to be enough capacity on the pump site to support all of that. So, my expectation is that for the first couple of quarters it may be gated by the pump availability but expecting that later in the year that that will be an expansion and certainly we are excited about the work that we're doing with SQL. We are working with them quite close; we've got a number of joint accounts that we're already calling on, so I expect that to be. A bigger part later in the second half of the year.

    但泵站確實需要有足夠的容量來支援所有這些。因此,我預計在前幾個季度,泵浦的可用性可能會受到限制,但預計今年稍後將會擴大規模,當然,我們對與 SQL 合作的工作感到興奮。我們與他們合作非常密切;我們已經啟動了一些聯合帳戶,所以我預計情況會是這樣。下半年稍後會佔更大比例。

  • Matt Miksic - Equity Research Analyst

    Matt Miksic - Equity Research Analyst

  • That's great. Well, congrats again and thanks so much for the color.

    那太棒了。再次恭喜,非常感謝你提供的顏色。

  • Operator

    Operator

  • Thank you. We'll go next now to Josh Jennings with TD Cowan.

    謝謝。接下來我們連線喬許·詹寧斯和TD·考恩。

  • Josh Jennings - Senior Analyst

    Josh Jennings - Senior Analyst

  • Hi. Good afternoon. Congratulations on the continued progress with the Eversense 365 launch. One of the objectives you've called out, Tim, it's been just enhancing access to Eversense 365 and the detail that EonCare built out. I was hoping to get a better understanding of... just how you envision the inserter network evolving from here outside of Eon and just ... how providers are, especially with the Medicare reimbursement that's in place and some private payers following with bundled payment reimbursement coverage, being attractive to a financial incentive for providers to be in planners, where do we stand today and how do you see that evolving as we move forward?

    你好。午安.恭喜 Eversense 365 發布工作持續取得進展。Tim,你提到的目標之一就是增強對 Eversense 365 的訪問以及 EonCare 構建的細節。我希望更了解…您設想的 Eon 之外的插入式網路將如何發展,以及…醫療服務提供者,特別是 Medicare 的報銷政策以及一些私人支付方跟進的打包支付報銷方案,如何為醫療服務提供者提供參與計劃的經濟激勵,我們目前的處境如何,您認為未來會如何發展?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah, so Josh, as we've spoken, the Eon is an important part because it really helps fulfill the need for our expansion, really in a lot of the primary care focus. When we go out and offer the opportunity to train on doing the insertion, of course, that's driven by the clinician's perspective. Many have an interest in doing it themselves, and they'll institutionalize it.

    是的,Josh,正如我們剛才所說,Eon 是一個重要的組成部分,因為它確實有助於滿足我們擴張的需求,尤其是在初級保健方面。當我們外出提供插管訓練機會時,這當然是由臨床醫師的視角所驅動的。許多人有興趣親自去做,他們會將其製度化。

  • We'll do the training on them, and we saw growth, certainly, in the quarter. In that population of folks—for those that don't have an interest in bringing it in, and we're seeing that in some cases in primary care where we're getting some of our new Medicare patients from—they don't yet have the installed base to go through to Eon. That's where the Eon Care works extremely well. So, we'll have a nurse in the area that they can refer to—somebody that has a nice connection with the patients and with the clinical staff—and we can work hand in hand to get that all coordinated to really help with a white-glove type handoff and treatment.

    我們會對他們進行培訓,而且我們確實在本季度看到了成長。在那部分人群中——對於那些沒有興趣引入它的人來說,我們看到,在某些情況下,初級保健機構(我們的一些新 Medicare 患者來自那裡)——他們還沒有足夠的用戶基礎來使用 Eon。這正是 Eon Care 的優勢所在。所以,我們會安排一位當地的護士,他們可以推薦給病人——一位與病人和臨床工作人員關係良好的護士——我們可以攜手合作,協調好一切,真正幫助實現細緻周到的交接和治療。

  • There are some folks that have recognized the attractiveness from the CPT code, and some of our largest prescribers and utilizers come from those as well. So they're more than willing and more than happy to institutionalize that. That insertion process—and that certainly continues to grow for us as well. We've got a number of very large accounts that are concentrated on because they see the benefit of Eversense for the patients. Being able to control that whole insertion process and be appropriately remunerated for it from the CPT codes is attractive for them as well.

    有些人已經認識到 CPT 代碼的吸引力,我們最大的處方醫生和使用者也來自這些醫生和使用者。所以他們非常願意也非常樂意將這種做法制度化。這種插入過程……而且對我們來說,它當然也在不斷發展。我們有很多非常大的客戶,我們之所以重點關注他們,是因為他們看到了Eversense對病人的好處。能夠控制整個插入過程並從 CPT 代碼中獲得適當的報酬,對他們來說也很有吸引力。

  • Josh Jennings - Senior Analyst

    Josh Jennings - Senior Analyst

  • Great, and I just was hoping to get a potential update on the private payers moving over to the bundled payment reimbursement. I know you guys have had some progress in the first half of the year, how that's trending, and how you expect that to trend into 2026. And then lastly, with the growth in prescribers in the provider community, maybe give us a sense of the mix between endos and PCPs—if that's kind of 50/50 or more heavily weighted towards endos or PCPs. Thanks for taking the questions.

    太好了,我正希望能了解一下私人支付方轉向打包支付報銷方式的最新進展。我知道你們在今年上半年取得了一些進展,請問目前的進展趨勢如何?你們預計 2026 年的進展趨勢又會如何?最後,隨著醫療服務提供者群體中處方醫生數量的增長,能否讓我們了解一下內科醫生和全科醫生之間的比例——是五五開,還是內科醫生或全科醫生的比例更高一些?謝謝您回答問題。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • So, we are still more heavily weighted towards the endos with the PCPs is certainly growing primary care, especially with that that Medicare expansion. I don't have the exact numbers, but I can certainly get that and get back to you, Josh, on it. Again, sorry, the first part of the question?

    所以,我們仍然更傾向於內分泌科醫生,而初級保健醫生無疑正在發展壯大,尤其是在醫療保險擴大之後。我沒有確切的數字,但我肯定可以拿到這些數字,然後儘快回覆你,喬許。再次抱歉,問題的第一部分是什麼?

  • Josh Jennings - Senior Analyst

    Josh Jennings - Senior Analyst

  • I was just hoping for an update on just private payers' kind of following CMS's lead and how they expect that to evolve from here and whether you could have a majority of private payers' kind of sometime in 2026 that may be too aggressive but love to hear your thoughts.

    我只是想了解一下私人支付方是否會效仿 CMS 的做法,以及他們預計未來會如何發展,還有,到 2026 年是否有可能出現大多數私人支付方都採取類似做法的情況——這可能有點過於激進,但我很想听聽您的想法。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah, I do expect to continue to transition. I would say the first half of the year we had a couple of large payers that transitioned—United, of course, being the largest. That was one of them that went to the bundled payment. I would expect that to continue as well. We are still working on the Kaiser partnership, and I would anticipate it will go in that direction as well—which would be in 2026. But otherwise, I do expect—because of the one-time use per year—it is more consistent with that buy-and-bill approach, and obviously we'll continue to support that. There are a fair number of folks that continue to, of course, offer it through the D&E channel, and we support those with our distributors. We'll work as best works for those payers, whether it's in that consignment buy-and-bill model or the traditional DME commercial. Right now, as you heard us say, it's about half and half, but we do expect that consignment channel to grow faster in 2026.

    是的,我預計會繼續轉型。我想說,今年上半年我們有幾家大型支付方進行了轉型——當然,最大的是聯合航空。其中一件就屬於打包付款的。我預計這種情況還會持續下去。我們仍在努力與凱撒醫療集團建立合作關係,我預期合作也會朝著這個方向發展——也就是在 2026 年。但除此之外,我確實認為——因為每年只使用一次——它更符合先買後付的方式,顯然我們會繼續支持這種方式。當然,還有相當一部分人繼續透過 D&E 管道提供這種產品,我們會透過我們的經銷商為他們提供支援。我們將盡最大努力為付款方服務,無論是寄售購買和結算模式還是傳統的DME商業模式。正如我們所說,目前兩者的比例大約是五五開,但我們預計到 2026 年,寄售管道的成長速度會更快。

  • Josh Jennings - Senior Analyst

    Josh Jennings - Senior Analyst

  • Great, thanks again.

    太好了,再次感謝。

  • Operator

    Operator

  • Thank you. We'll go next now to Anthony Petrone with the Mizuho Group.

    謝謝。接下來我們連線瑞穗集團的安東尼佩特羅內。

  • Anthony Petrone - Senior Equity Research Analyst

    Anthony Petrone - Senior Equity Research Analyst

  • Hi, good afternoon, everyone. Thanks, for taking a question. Congrats on the quarter here. Maybe on the Ascensia transition, as we head into that Gen 1 2026 go-live—a lot of the reps from Ascensia jumping over—but of course there'll also be a DTC push here from Senseonics. So maybe, you know, what does that push look like, when does it start? What will be the commitment at the SG&A line, how does that layer in through 2026? And then, I'll have a follow-up on new patient stats.

    大家好,下午好。謝謝您回答問題。恭喜你本季取得佳績。也許在 Ascensia 過渡期間,隨著我們進入 2026 年第一代產品上線階段——Ascensia 的許多代表都會跳槽過來——當然,Senseonics 也會在這裡大力推廣 DTC 產品。所以,你知道,這種推動力是什麼樣的,它何時開始?銷售、一般及行政費用的投入將如何安排?到 2026 年,這些投入將如何逐步落實?然後,我將跟進新患者統計數據。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah, so we've definitely seen progress, Anthony, as you've heard of the DTC, clearly awareness is an area that we can invest in and continue to grow, and it's exciting to bring those new patients to the product. I would anticipate that the level of DTC that we've invested in in 2025 will materially be consistent. In 2026 will of course gate it to the buying patterns. As you'll recall, the 4th quarter is really the largest, especially for, a more expensive piece of medical equipment with new deductibles and so forth, and Q1, it tends to soften a little bit. So, I do expect that to be a material part of the combined investment that we're going to make as the new Onyx after January 1, and we do expect that it will continue to show good positive trends for us.

    是的,安東尼,我們確實看到了進展。如你所知,DTC(直接面向消費者)顯然是一個我們可以投資並繼續發展的領域,能夠將這些新患者引入產品令人興奮。我預計到 2025 年,我們在 DTC 領域的投資水準將基本保持不變。當然,2026 年的結果將取決於購買模式。您應該記得,第四季度通常是最大的季度,尤其是對於價格較高的醫療設備而言,因為新的免賠額等等,而第一季往往會略有放緩。因此,我預計這將是我們作為新的 Onyx 在 1 月 1 日之後進行的聯合投資的重要組成部分,我們也預計它將繼續為我們帶來良好的積極趨勢。

  • Anthony Petrone - Senior Equity Research Analyst

    Anthony Petrone - Senior Equity Research Analyst

  • That's helpful. And then DTC, new patient starts rather record in 3Q record in September, maybe if you could provide a little bit of color on October trends.

    那很有幫助。然後是DTC,新患者數量在第三季創下紀錄,9月也創下紀錄,也許您能稍微介紹一下10月的趨勢。

  • Which would be helpful on new patients starts and when you look at the space in totality, there was just some noise out there. Abbott, had a dis distributor sort of, destock, kind of event and then, Dexcom had some issues with supply specifically.

    這對於新患者的開始治療會很有幫助,而且從整體上看,這個領域存在一些幹擾因素。雅培公司經歷了類似經銷商清倉的事件,然後,德康公司在供應方面也遇到了一些問題。

  • So, it seems like some share shifted around. It looks like the company gained some of that share.

    所以,似乎部分股票發生了轉移。看來該公司已經獲得了一些市場份額。

  • But maybe the competitive, dynamic, how do you, any long-lasting patterns that you're noticing, anything that's out of the ordinary and type 2 basal only.

    但也許競爭性、動態性、你如何、你注意到的任何長期模式、任何不尋常的事情以及 2 型基礎型都只是。

  • So just some of the context on new patients starts in October and how it's shaken out competitively. Thanks.

    所以,關於新患者的情況,從 10 月開始,以及競爭格局是如何變化的,這裡有一些背景資訊。謝謝。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah. Yeah, I would say, as you're aware, the guidance that we've given calls for a very material Q4. And certainly, October appears to be no disappointment in heading us down that path, which is obviously the basis of us of us giving that very big guidance.

    是的。是的,如您所知,我們給予的業績指引預計第四季將取得非常顯著的成績。當然,10 月似乎也沒有讓我們失望,它引領我們走向了這條道路,這顯然是我們給出這一重大指導的基礎。

  • From a supply perspective, there's certainly no issues on the on the side. We continue to supply, from a competitive perspective, as I said, I don't know really where it comes from. I think the majority of it H1ly is the reach, right as we get awareness up higher and higher with that DTC investment we're waiting. The first people that typically respond to those that are currently on a product. They may be looking for some element whether it's duration, the improved accuracy that we have, or just that long-term.

    從供應角度來看,這方面肯定沒有任何問題。從競爭的角度來看,我們仍在繼續供應,正如我所說,我真的不知道它來自哪裡。我認為 H1ly 的主要問題是覆蓋面,隨著我們透過 DTC 投資不斷提高知名度,我們正在等待時機。首先,那些正在使用該產品的人通常會做出回應。他們可能在尋找某些要素,無論是持續時間、我們擁有的更高精度,還是只是長期發展。

  • Put the sensor in and enjoy it for the next 365 days is really attracting people over to it. So, no supply issues, certainly no destocking. As Rick has told you, we—Ascensia's kept about 60 days' worth of supply in the channel. We're going to work to tighten that up in 2026, but there's been no impact in 2025. Basal-only continues to be very interesting for us—a good portion of our Medicare patients, of course, basal-only, and those that we convinced to try the product have been very excited with it—very happy with the performance. It does take a little bit longer to do the sale on the basil only patients just because they're coming from more of a naive position on CGM, whereas, of course, anybody that might be on a pump or even in the iCGM is just further up the technology learning curve. Thanks again.

    將感測器放入體內,即可享受接下來 365 天的服務,這確實很吸引人。所以,不存在供應問題,當然也不會出現清倉狀況。正如里克告訴你們的那樣,我們Ascensia在渠道中儲備了大約60天的供應量。我們將在 2026 年努力收緊這個問題,但 2025 年尚未產生任何影響。對我們來說,基礎胰島素療法仍然非常有趣——當然,我們很大一部分醫療保險患者都只接受基礎胰島素療法,而我們說服他們嘗試該產品的患者也對它非常興奮——對它的效果非常滿意。對於只使用羅勒的患者來說,銷售過程確實需要更長的時間,因為他們對 CGM 的了解還比較淺薄,而那些使用胰島素幫浦甚至 iCGM 的患者,當然在技術學習曲線上已經走得更遠了。再次感謝。

  • Anthony Petrone - Senior Equity Research Analyst

    Anthony Petrone - Senior Equity Research Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Thank you. We'll go next now to Jonathan Block with Stifel.

    謝謝。接下來我們連線Stifel公司的Jonathan Block。

  • Jonathan Block - Director

    Jonathan Block - Director

  • Thanks, and good afternoon, guys.

    謝謝,各位下午好。

  • Rick, maybe just high level or conceptually for 26, and I know you don't want to give specifics, but again, just conceptually. Do we sort of like take our previous top-line thoughts and gross it up by, approximately 20% or there's some, call it international markets that you might not pursue or more of a scaled back approach, now that you'll be able to go at it from a direct perspective.

    Rick,也許只是從高層次或概念上來說,關於第 26 題,我知道你不想給出具體細節,但再說一遍,只是概念上。我們是否可以把之前的主要想法再增加約 20%?或者,考慮到一些國際市場,你可能不會去開拓,或採取規模較小的策略,現在你可以從更直接的角度開拓這些市場了。

  • Rick Sullivan - Chief Financial Officer

    Rick Sullivan - Chief Financial Officer

  • Yeah, hey John, thanks for the question. So, as I think about it and I alluded to briefly in my prepared remarks, there's likely going to be some inventory dynamics. I've mentioned before with Ascencia holding somewhere between 60 and 90 days between them and the other sales channels and we're going to reduce that. We're going to be closer to 30 days, so that means there's 1 or 2 months of inventory in the channel that we won't recognize revenue on for next year. So, we're not going to see the full 20%. So, it's not as simple as that, but we will see the margin improvement that I've talked about for everything that we do sell. So, we will see those margins up at 50%.

    嘿,約翰,謝謝你的提問。所以,仔細想想,正如我在準備好的發言稿中簡要提到的,庫存可能會出現一些動態變化。我之前提到過,Ascencia 與其他銷售管道之間大約有 60 到 90 天的間隔,我們將縮短這個間隔。距離30天左右就差不多了,這意味著通路中會有1到2個月的庫存,明年我們將無法確認這些庫存的收入。所以,我們不會看到全部的 20%。所以,事情並沒有那麼簡單,但我們銷售的所有產品都將實現我所說的利潤率提升。所以,我們將看到這些利潤率上升到 50%。

  • Jonathan Block - Director

    Jonathan Block - Director

  • Okay, in the international? market dynamic or TBD?

    好的,在國際層面?市場情勢尚不明朗?

  • Rick Sullivan - Chief Financial Officer

    Rick Sullivan - Chief Financial Officer

  • So you know I think we talked about it briefly excited to launch the 365 day product OUS with our own sales force and so you know we made that conscious decision to wait till we had our entities established and had high our own reps to really launch the products the way we want to and so that'll be in the first half of the year and you know until then it's going to be a steady state in Europe and then we'll expect to see the similar growth as we did in the US outside the US.

    所以,我們之前簡單討論過,很興奮能用我們自己的銷售團隊在美國推出365天產品。但我們後來決定,要等到我們的實體機構建立起來,擁有自己的銷售代表之後,才能真正按照我們想要的方式推出產品。所以,這將在今年上半年進行。在此之前,歐洲市場將保持穩定。之後,我們預期美國以外地區的市場也將出現與美國類似的成長。

  • Jonathan Block - Director

    Jonathan Block - Director

  • Okay, fair enough. Thank thanks for that caller. And then Tim, just to shift gears, I thought I heard you correctly. Maybe you lose your ... in early 2028. And I thought previously in my mind it was late 2027. I know we're talking a way out, but I was just curious if I've got that correct and then was there anything specific on why that would be a new sort of early 28 versus previous target of back half of 2027.

    好吧,這說得有道理。謝謝這位來電者。然後,提姆,換個話題,我想我沒聽錯吧。也許你會在 2028 年初失去你的…我之前一直以為是 2027 年末。我知道我們是在討論解決辦法,但我只是好奇我的理解是否正確,以及為什麼這會是 2028 年初的新目標,而不是之前 2027 年下半年的目標,這其中有什麼具體的原因嗎?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Thank you, John. No change in the development schedule at all. I was referring to really the commercial contribution would really be in 2028, right, as the anticipated approval is just that continues to be that in the in the fourth quarter of 2027, but it really has the ability to contribute to the 2028 fiscal year.

    謝謝你,約翰。開發進度安排沒有任何變化。我指的是,真正的商業貢獻將在 2028 年實現,對吧?因為預計的批准時間仍然是 2027 年第四季度,但它確實有能力為 2028 財年做出貢獻。

  • Jonathan Block - Director

    Jonathan Block - Director

  • Fair enough, thank you.

    好的,謝謝。

  • Operator

    Operator

  • Thank you. We go next now to Ben Haynor of Lake Street Capital Markets.

    謝謝。接下來我們連線 Lake Street Capital Markets 的 Ben Haynor。

  • Ben Haynor - Managing Director

    Ben Haynor - Managing Director

  • Good afternoon, gentlemen. Thanks for taking the questions. Just wondering on the DTC marketing spend, as you kind of look at the data there and, slice and dice it by demographics, geographies, what have you, do you see that, X dollars in equal. Why patients, do you see any sort of saturation or inflections as you spend more over time, or how does that kind of track and various subsegments of the folks you're targeting the geographies you're targeting?

    下午好,先生們。謝謝您回答問題。我只是想了解 DTC 行銷支出,當你查看那裡的數據,並按人口統計、地理位置等進行細分時,你是否發現 X 美元是相等的。為什麼說患者?隨著時間的推移,您是否觀察到任何飽和或拐點?或者,這種趨勢如何追蹤您針對的不同人群細分群體以及您針對的地理位置?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah, Thanks, Ben. Yes, there's a number of observations. Clearly, as you increase the spend on PPC, there absolutely is a direct increase on the number of patients coming to ever since, which is good news. It is, however, obviously a conversion process you need to go through. There is quite a bit of education and obviously we, we've been continuing to optimize the algorithms of who we reach. Obviously, the reimbursement for folks that are on insulin is one of the key things that we look for. We did run some pilot work where we were doing some linear television, and in that recognized that we got a much broader audience. Many of those folks were actually not on insulin or they were looking for, starter material.

    謝謝你,本。是的,有很多觀察。顯然,隨著您在 PPC 上的支出增加,前來就診的患者數量也必然會直接增加,這是個好消息。然而,這顯然是一個需要經歷的轉變過程。我們投入了大量精力進行教育,而且顯然,我們一直在不斷優化演算法,以便更好地觸及目標受眾。顯然,對於使用胰島素的人來說,報銷情況是我們關注的重點之一。我們確實進行了一些試播工作,嘗試製作一些線性電視節目,並在試播中發現我們獲得了更廣泛的受眾。這些人中很多實際上並沒有使用胰島素,或者他們正在尋找胰島素的起始原料。

  • In the sense of, something that they could try for free, perhaps Medicaid patients where there isn't good reimbursement yet. So, we certainly recognize that as you go very broad. In the advertisements, you do get less and less in the center of the bull's eyes. So therefore, you, the effectiveness of the investment can drop off in that that debt. So, we've tried to stay pretty pointed, pretty geo targeted as you know what we can do with the investment these days. But we also of course tie that to where we make sure that we have good depth of insertion capability Eon gives us an opportunity as well. We're approaching 50 Eon nurses and we're exciting. One of the reasons that we're going to double that to 100 next year is just because of that breadth that we can get with it and then further expand the DTC investment from that.

    從某種意義上說,這或許是他們可以免費嘗試的東西,特別是對於那些還沒有獲得良好報銷的醫療補助患者而言。所以,當你的範圍非常廣泛時,我們當然會意識到這一點。在廣告中,你越來越難看到正中靶心的畫面了。所以,因此,投資的有效性可能會因為債務而下降。所以,我們一直努力保持精準性,並盡可能地進行地域性定位,因為你知道,如今我們可以利用投資做很多事情。當然,我們也要確保我們擁有良好的深度部署能力,Eon 也給了我們這樣的機會。我們即將擁有 50 名 Eon 護士,這令人振奮。我們明年將規模擴大一倍至 100 的原因之一,就是因為我們可以透過這種方式獲得更廣泛的覆蓋面,然後在此基礎上進一步擴大 DTC 投資。

  • Ben Haynor - Managing Director

    Ben Haynor - Managing Director

  • Okay, great. Thanks for the color there. And then, lastly for me, I appreciate that, you don't plan on giving guidance until, January for 2026, but I think high level, you've talked about, kind of roughly doubling patients this year, doubling patients next year and the following year. Has there been any change to your thinking on kind of that high level, of, patient doubling?

    好的,太好了。謝謝你帶來的色彩。最後,我很欣賞您不打算在 2026 年 1 月之前給出指導意見,但我認為從總體上看,您已經談到今年患者人數大致翻一番,明年和後年患者人數也大致翻一番。您對病人數量翻倍這種高層次的問題,您的想法是否有改變?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • No, we're still driving John to do exactly that, Ben, I'm sorry. And making the investments that we talked about with the with the DPC, I do want to echo Rick's comments. We do have this one time dynamic as we switch from Aya and Senseonics, right, where they had product in the channel, they cap about 30 days, they put up the 60 days with the distributors. We're certainly going to try to pull that back, but in the normal practice they of course do have that in the channel, so that'll have a one-time impact. In 2026, it's not going to impact patient starts, but since the product is in the channel, they'll need to be some consideration for that for the first 60 days or so of the year as we as we go through that transition.

    不,本,我很抱歉,我們還在逼約翰去做這件事。至於我們與DPC討論過的那些投資,我完全同意Rick的觀點。我們確實遇到了這種特殊情況,因為我們從 Aya 和 Senseonics 過渡過來,對吧?他們的產品在通路中最多只能維持 30 天,而他們與經銷商合作時,則允許他們維持 60 天。我們當然會盡力阻止這種情況發生,但通常情況下,他們確實會在頻道中這樣做,所以這只會產生一次性的影響。到 2026 年,這不會影響患者開始治療,但由於該產品已進入管道,因此在當年的前 60 天左右,在我們經歷過渡期時,他們需要對此有所考慮。

  • Ben Haynor - Managing Director

    Ben Haynor - Managing Director

  • Makes sense. Got it. Well, thanks for taking the questions, gentlemen.

    有道理。知道了。謝謝各位回答問題。

  • Operator

    Operator

  • Thank you. We go next now to Jayson Bedford of Raymond James.

    謝謝。接下來我們請Raymond James公司的Jayson Bedford上台。

  • Jayson Bedford - Equity Research Director

    Jayson Bedford - Equity Research Director

  • Good afternoon. Just a couple quick ones I guess on the $35 million in revenue guidance, I think the old guidance was 34 to 38, just any details on what changed?

    午安.關於3500萬美元的營收預期,我想問幾個簡單的問題。我記得之前的預期是3400萬到3800萬美元,請問有什麼細節改變了嗎?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • No, we're right in that range, Jason. I think as we get more fine-tuned and manage this inventory transition between Ascensia and us, it just gives us a little bit better visibility. As I said, we're still absolutely on track for doubling the patience, so, the revenue behind it is just dictated by timing or, some of these transition accounting dynamics.

    不,我們就在這個範圍內,傑森。我認為,隨著我們對 Ascensia 和我們之間的庫存交接進行更精細的調整和管理,這將使我們對庫存情況有更清晰的了解。正如我所說,我們仍然完全有信心將耐心值提高一倍,因此,背後的收入只是取決於時間安排或一些過渡會計動態。

  • Jayson Bedford - Equity Research Director

    Jayson Bedford - Equity Research Director

  • Okay, on the SG&A spend, a little bit of lift there, is there any way to frame the size of the DTC spend and I assume this continues in the 4th quarter.

    好的,關於銷售、一般及行政費用,略有成長,有沒有辦法描述直接面對消費者的支出規模?我假設這種情況會持續到第四季。

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Yeah, Rick, you want to go through that?

    是啊,瑞克,你想經歷這一切嗎?

  • Rick Sullivan - Chief Financial Officer

    Rick Sullivan - Chief Financial Officer

  • Yeah, I mean, much of the list was the DTC spend that we made in the 3rd Quarter, and it'll be similar in the 4th quarter. I mean I think we raised our cash utilization range to the top at $60 and so you know it's up to $10 million in DTC for the for the year that we're going to be spending to bring up the awareness.

    是的,我的意思是,這份清單上的大部分內容都是我們在第三季進行的直接面向消費者(DTC)支出,第四季的情況也類似。我的意思是,我認為我們將現金使用範圍提高到了上限 60 美元,所以你知道,今年我們將在 DTC 上花費高達 1000 萬美元來提高品牌知名度。

  • Jayson Bedford - Equity Research Director

    Jayson Bedford - Equity Research Director

  • Okay, and then just lastly on Twist, what's left to be done here? Is it all in in ... hands right now?

    好的,最後關於 Twist,還有什麼需要完成的嗎?現在一切都掌握在…手中了嗎?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • There are joint marketing activities that need to be done. There are some scaling activities that Twist is going through at this point, so we're essentially ready to go, and I know they're getting pretty close as well. So, we're down to the 5- or 10-year line.

    需要開展一些聯合行銷活動。Twist 目前正在進行一些規模化活動,所以我們基本上已經準備就緒,我知道他們也即將完成。所以,我們現在面臨的是 5 年或 10 年的期限。

  • Jayson Bedford - Equity Research Director

    Jayson Bedford - Equity Research Director

  • Okay, thanks.

    好的,謝謝。

  • Operator

    Operator

  • Thank you. We'll go next now to Sean Lee with HC Wainwright.

    謝謝。接下來我們連線 Sean Lee 和 HC Wainwright。

  • Sean Lee - Equity Research Analyst

    Sean Lee - Equity Research Analyst

  • Hey guys, good afternoon. Thanks for taking my questions. I'm just have a couple ones on the European side of the business. I may have missed it, but did you provide an update on the C mark for the Eversense 365 and understand that the transition on Europe is expected to take longer.

    各位,下午好。謝謝您回答我的問題。我在歐洲那邊只有幾個客戶。我可能錯過了,但您有沒有提供關於Eversense 365 C標誌的最新資訊?我了解到歐洲的過渡預計需要更長時間。

  • Are you also transitioning the associate employees over or building a new team from the ground up on that side and what else, should we, oh, sorry, what other cars do you provide on the transition process there?

    你們是將現有員工過渡過去,還是從零開始組成新的團隊?還有,我們應該…哦,不好意思,在過渡過程中,你們還提供哪些其他車輛?

  • Tim Goodnow - President and Chief Executive Officer

    Tim Goodnow - President and Chief Executive Officer

  • Sure. CD marketing and then I'll let you pick up on the.

    當然。CD行銷,然後我就讓你自己去體會吧。

  • On that transition and our thoughts on launching 365 on CE Mark, we continue to be on track. Obviously we'd like to have it sooner rather than later. We did submit it in February, so it has been under review for some time period. There are no issues. We are down to the very final stages, so that's why we continue to believe that we'll have the approval on it here this quarter.

    關於過渡以及我們對推出獲得 CE 認證的 365 的看法,我們仍然在按計劃進行。我們當然希望它能盡快實現。我們二月就提交了,所以已經審核了一段時間了。沒有任何問題。我們已經進入最後階段,所以我們仍然相信本季就能獲得批准。

  • Unfortunately, the CE marking we use BSI, they're not actually a little bit less predictable than the FDA is, and I think we're just in their normal process of final review. So, no issues, nothing new, we're certainly happy to get it over to the folks in Europe, but with the transition, we are thinking a little bit different about when to bring it out, and Rick, I'll let you speak to that.

    不幸的是,我們使用的 CE 標誌來自 BSI,實際上他們的可靠性不如 FDA,我認為我們只是處於他們正常的最終審查流程中。所以,沒有問題,沒有什麼新情況,我們當然很高興能把它交給歐洲的朋友們,但是隨著過渡期的到來,我們對何時推出它有了不同的看法,里克,這方面就由你來談談吧。

  • Rick Sullivan - Chief Financial Officer

    Rick Sullivan - Chief Financial Officer

  • Yeah, that's right. So, we are transitioning the European business over the first half of the year. We're in the process of setting up our entities. We'll transition the current CGM dedicated employees and then hire our own sales force. And so, there was some 365 contribution that we previously thought for revenue in 2025, but making the decision to launch the product with our own sales force that we directed control is certainly the way to go. So, we'll launch that product in the first half of the year with our own sales force outside the US.

    是的,沒錯。因此,我們將在今年上半年逐步過渡歐洲業務。我們正在籌建公司。我們將把目前 CGM 的專職員工過渡到新職位,然後招募我們自己的銷售團隊。因此,我們之前認為 365 會在 2025 年帶來一些收入,但決定由我們自己的銷售團隊來推出產品,並由我們直接控制,這無疑是正確的做法。因此,我們將在今年上半年透過我們自己的美國以外銷售團隊推出該產品。

  • Sean Lee - Equity Research Analyst

    Sean Lee - Equity Research Analyst

  • Great. Thanks for the additional call on that.

    偉大的。感謝您就此事再次致電。

  • Operator

    Operator

  • Thank you. Ladies and gentlemen, it appears we have no further questions this afternoon, so that will bring us to the conclusion of today's conference call. We'd like to thank you all so much for joining us this afternoon for our conference and wish you all a great remainder of your day. Goodbye everyone.

    謝謝。女士們、先生們,今天下午似乎沒有其他問題了,所以今天的電話會議就到此結束。非常感謝各位今天下午蒞臨參加我們的會議,祝福大家今天剩下的時間愉快。各位再見。