Senseonics Holdings Inc (SENS) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good day, everyone, and welcome to Senseonics first-quarter 2026 earnings call. (Operator Instructions) Please note today's call will be recorded and I'll be standing by should you need any assistance. It is now my pleasure to turn the conference over to Jeremy Feffer from LifeSci Advisors. Please go ahead.

    各位好,歡迎參加 Senseonics 2026 年第一季財報電話會議。(接線員指示) 請注意,今天的電話會議將被錄音;如您需要任何協助,我將隨時待命。現在我很高興將會議交給 LifeSci Advisors 的 Jeremy Feffer。請開始。

  • Jeremy Feffer - Investor Relations

    Jeremy Feffer - Investor Relations

  • Thank you. This is Jeremy Feffer 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.

    謝謝。我是 LifeSci Advisors 的 Jeremy Feffer。在我們今天開始之前,提醒各位公司發言將包含前瞻性陳述。這些陳述反映管理層對未來事件、營運計畫、監管事項、產品強化、公司表現及其他事項的預期,且僅截至本日為止有效。這些前瞻性陳述涉及多項風險與不確定性。

  • 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 10-K for the year ended December 31, 2025, and our 10-Qs and our other reports filed with the SEC. These documents are available on the Investor Relations section of our website at www.senseonics.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason, except as required by law.

    可能導致實際結果與任何此等前瞻性陳述所明示或暗示者存在重大差異的因素清單,已在截至 2025 年 12 月 31 日止年度之 Form 10-K 年報的「風險因素」及其他章節,以及我們提交給 SEC 的 10-Q 與其他報告中詳述。這些文件可於我們網站 www.senseonics.com 的投資人關係專區取得。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陳述之義務。

  • Joining me today from Senseonics are Tim Goodnow, President and Chief Executive Officer; and Rick Sullivan, Chief Financial Officer. Brian Hansen, Chief Commercial Officer, will also be available during the Q&A.

    今天與我一同出席的 Senseonics 代表包括:總裁兼執行長 Tim Goodnow,以及財務長 Rick Sullivan。商務長 Brian Hansen 也將在問答環節中待命。

  • Now I'll turn the call over to Tim.

    現在我把電話交給 Tim。

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Thanks, Jeremy, and I appreciate everyone joining us today. 2026 is off to a very strong start for Senseonics commercially and strategically. In the first quarter, we delivered $11.7 million in revenue and 58% gross margin. We view the combination of top line growth and margin expansion as early validation that our integrated commercial model can deliver with improving financial performance as we scale. Given all of this, we are raising our full-year 2026 global net revenue guidance to $60 million to $64 million from $58 million to $62 million, representing year-over-year growth of 70% to 82%.

    謝謝你,Jeremy,也感謝各位今天加入我們。對 Senseonics 而言,2026 年在商業與策略層面都迎來非常強勁的開局。第一季我們實現營收 1,170 萬美元,毛利率 58%。我們認為,營收成長與毛利率擴張的結合,是對我們整合式商業模式在規模擴張過程中能帶來更佳財務表現的初步驗證。基於上述進展,我們將 2026 全年全球淨營收指引由 5,800 萬至 6,200 萬美元上調至 6,000 萬至 6,400 萬美元,代表年增 70% 至 82%。

  • Beyond the financial results, we successfully completed the integration of the US commercial organization, continued progress towards completing the European commercial integration, launched our first AID partnership, advanced our Gemini and Freedom development programs and added over $100 million in growth capital to our balance sheet.

    除財務成果外,我們也成功完成美國商業組織的整合,並持續推進歐洲商業整合的完成;啟動我們第一個 AID 合作夥伴關係;推進 Gemini 與 Freedom 研發計畫;並為資產負債表新增超過 1 億美元的成長資金。

  • Taken together, these accomplishments give Senseonics the commercial control, the product pipeline and the financial resources to drive Eversense revenue growth, first through our compelling Eversense 365 offering and then through the next-generation CGM system that we are developing. We're at an exciting stage of our journey and the opportunity ahead for Senseonics is significant. There's a lot more work to do, but we are now in control of our destiny with the right team, structure and strategy in place to accelerate our recent momentum.

    綜合而言,這些成果使 Senseonics 具備商業掌控力、產品研發管線與財務資源,以推動 Eversense 營收成長:首先透過我們具吸引力的 Eversense 365 產品,接著透過我們正在開發的下一代 CGM 系統。我們正處於旅程中令人振奮的階段,Senseonics 未來的機會相當可觀。仍有許多工作要做,但我們現在已能掌握自身命運,並具備合適的團隊、架構與策略,以加速近期的成長動能。

  • Now I'd like to provide more detail on the encouraging progress so far this year. On the commercial side, execution was strong. The first quarter of 2026 was our first full quarter with direct ownership of the Eversense commercial organization in the US following the January 1 transition from Ascensia Diabetes Care. Having the commercial team inside Senseonics gives us the ability to align sales strategy, field execution and market access priorities with our product development and our qualified manufacturing partners.

    接下來我想更詳細說明今年迄今令人鼓舞的進展。在商業面,執行力表現強勁。2026 年第一季是我們在 1 月 1 日自 Ascensia Diabetes Care 完成交接後,首次在美國直接擁有 Eversense 商業組織的完整季度。將商業團隊納入 Senseonics 內部,使我們能把銷售策略、前線執行與市場准入(market access)優先事項,與產品開發及合格的製造合作夥伴進行一致化。

  • This has been invaluable and that alignment contributed to an exceptional financial quarter. In the quarter, we generated revenue of $11.7 million, a strong financial result that reflects growing Eversense 365 adoption in the US and a focused reimbursement channel mix, which Rick will detail shortly. Equally important, gross margin reached 58%, driven by more new users, higher manufacturing volumes and the structural benefit of eliminating the Ascensia revenue share. We view the combination of top line growth and margin expansion as early validation that our integrated commercial model can deliver with improving financial performance as we scale.

    這一點極具價值,而這種一致性也促成了卓越的財務季度表現。本季我們創造 1,170 萬美元營收,這項強勁成果反映 Eversense 365 在美國的採用率提升,以及更聚焦的給付通路組合,Rick 稍後將進一步說明。同樣重要的是,毛利率達到 58%,主要受惠於新用戶增加、製造量提升,以及取消 Ascensia 分潤所帶來的結構性效益。我們認為,營收成長與毛利率擴張的結合,是對我們整合式商業模式在規模擴張過程中能帶來更佳財務表現的初步驗證。

  • Eversense sales have continued to grow, and we believe we remain on track to double patients this year in the US. Our direct-to-consumer channel continues to yield strong results. In 2025, DTC sourced new patient shipments doubled year-over-year. And within the year, our monthly DTC new patient volumes grew more than fourfold from January through December as we scaled our investment. That momentum carried into 2026.

    Eversense 銷售持續成長,我們相信今年在美國仍有望達成患者數翻倍的目標。我們的直達消費者(DTC)通路持續帶來強勁成果。在 2025 年,DTC 來源的新患者出貨量年增一倍。且在該年度內,隨著我們擴大投資,DTC 每月新患者量自 1 月至 12 月成長超過四倍。這股動能延續至 2026 年。

  • In Q1, DTC sourced new patient shipments grew nearly 100% compared to the first quarter of 2025, with DTC accounting for roughly 60% of all new patient shipments in the quarter. The health care professional channel is also growing as our sales reps continue to become more efficient with March providing the most HCP sales leads in the company's history.

    第一季,DTC 來源的新患者出貨量較 2025 年第一季成長近 100%,且 DTC 約占本季所有新患者出貨量的 60%。醫療專業人員(HCP)通路也在成長,因為我們的業務代表持續提升效率;3 月更創下公司史上最高的 HCP 銷售線索數。

  • We're also encouraged that patient reorders tracked above plan in Q1, an early signal of the retention dynamics we expect from our year-long product. Following the positive reception of Eversense 365 in the US, we anticipate the current launch of our year-long sensor in Europe will support growth in these markets as well. In April, we inserted our first patients in Sweden, followed by Spain earlier this week.

    我們也很受鼓舞地看到,第一季患者再訂購(reorder)表現高於計畫,這是我們對一年期產品所預期留存動態的早期訊號。在 Eversense 365 於美國獲得正面回饋後,我們預期目前在歐洲推出一年期感測器也將支持這些市場的成長。4 月我們在瑞典為首批患者完成植入,並於本週稍早在西班牙完成後續植入。

  • And we're in the process of launching across Germany and Italy, rounding out the four European markets we'll be serving following the transition of Ascensia's commercial organization. We also see Eon Care as an increasingly important growth driver for Eversense. Eon now has over 70 nurses available for insertions, and the team is well on its way towards our goal of 100 nurses by the end of the year. Critically, Eon Care now performs more than one-third of all Eversense insertion procedures. To put the reach of our broadening network in perspective, we have established Eon in 34 states and are continuing to grow its reach.

    我們也正在德國與義大利推進上市,完成在 Ascensia 商業組織移轉後我們將服務的四個歐洲市場。我們也認為 Eon Care 正成為推動 Eversense 成長日益重要的動能。Eon 目前已有超過 70 名護理師可提供植入服務,團隊正穩步朝年底達到 100 名護理師的目標前進。關鍵的是,Eon Care 現在執行超過三分之一的 Eversense 植入手術。為了讓各位了解我們持續擴大的網路覆蓋範圍,我們已在 34 個州建立 Eon 服務,並持續擴展其觸及範圍。

  • This expansion across the country reduces geographic barriers that may have previously limited implantable CGM adoption. That reach is significant for several reasons. First, it means that we have built meaningful insertion capacity that is not dependent on individual physician practices. This lowers the barrier for prescribers who offer Eversense. Second, it gives patients a more convenient path to access the only year-long CGM, including in markets where inserting physician availability has historically been a constraint.

    這項全國性的擴張降低了地理因素所造成的障礙,而這些障礙過去可能限制可植入式 CGM 的採用。這樣的覆蓋範圍之所以重要,有幾個原因。第一,這代表我們已建立具規模的植入量能,不再依賴個別醫師診所。這降低了提供 Eversense 的處方醫師門檻。第二,這讓患者能以更便利的方式取得唯一的一年期 CGM,即使是在過去因植入醫師可用性長期受限的市場亦然。

  • And third, it provides Senseonics with a scalable service infrastructure that grows alongside our patient base. We expect Eon Care's share of insertions to continue increasing over the rest of the year as we add more nurses and further expand geographic coverage.

    第三,它為 Senseonics 提供可擴展的服務基礎設施,能隨著我們的病患基礎一同成長。隨著我們增加更多護理人員並進一步擴大地理覆蓋範圍,我們預期 Eon Care 的植入占比在今年剩餘時間將持續提高。

  • In addition, the availability of Eversense with our first automated insulin delivery platform will continue to support our growth. In February, we announced the integration of Sequel Med Tech's twiist insulin pump with Eversense 365, the first automated insulin delivery system to integrate with a year-long CGM. Not only does this integration expand the options available to people with diabetes, but it also provides a technology that fits the reality of their lives.

    此外,Eversense 與我們第一個自動化胰島素輸送(AID)平台的可用性,將持續支持我們的成長。今年 2 月,我們宣布將 Sequel Med Tech 的 twiist 胰島素幫浦與 Eversense 365 整合,這是首個與一年期 CGM 整合的自動化胰島素輸送系統。這項整合不僅擴大了糖尿病患者可選擇的方案,也提供了一項更符合其生活現實的技術。

  • Our efforts have brought two advanced platforms to users, is combining the precision of the twiist insulin delivery system with the unmatched longevity and performance of Eversense 365 in a flexible, convenient offering. We continue to pursue additional opportunities to integrate Eversense with other pump platforms and are very encouraged by the early uptake of Eversense 365 as part of our first AID system. We've seen good early adoption with twiist. We've had exceptional anecdotal feedback from the initial users and the data presented at ATTD puts early numbers to the positive impact this combination is having.

    我們的努力已為使用者帶來兩個先進平台,將 twiist 胰島素輸送系統的精準度與 Eversense 365 無可匹敵的長效性與效能結合,提供彈性且便利的方案。我們持續尋求將 Eversense 與其他幫浦平台整合的更多機會,並且對於 Eversense 365 作為我們第一個 AID 系統一部分的早期採用情況感到非常振奮。我們已看到 twiist 的良好早期採用。我們從初期使用者獲得了極佳的口碑回饋,而在 ATTD 發表的數據也以初步數字量化了這項組合所帶來的正面影響。

  • I also encourage you to check out the data to be presented by our Chief Medical Officer, Dr. Francine Kaufman, at the ADA. This is further real-world evidence on Eversense 365, and the data shows a full year of strong patient adherence, glucometrics and hypoglycemic outcomes. It also validates our sensor's performance and accuracy across an entire year with the same performance between the first and second six-month periods.

    我也鼓勵各位關注我們首席醫療官 Francine Kaufman 醫師將在 ADA 發表的數據。這是關於 Eversense 365 的進一步真實世界證據,數據顯示病患在整整一年中具有強勁的依從性、血糖指標(glucometrics)以及低血糖結果。同時也驗證了我們感測器在整整一年期間的效能與準確性,且前後兩個六個月期間的表現一致。

  • Generally, we are very pleased with the progress we are making in advancing our penetration in the Type 1 population. All of these areas of commercial progress are encouraging, and I look forward to continuing the exciting commercial momentum that is building.

    整體而言,我們對於在第一型糖尿病族群中提升滲透率所取得的進展感到非常滿意。上述各項商業進展都令人鼓舞,我也期待延續目前正在形成的令人振奮的商業動能。

  • Significantly, this momentum is driven by the successful integration of the Ascensia commercial organization into Senseonics. As an update on this initiative, we brought the Ascensia US CGM organization into Senseonics on January 1, and that transition has gone smoothly as evidenced by our first quarter performance. The US territories are effectively running and showing progress.

    值得注意的是,這股動能來自 Ascensia 商業組織成功整合進 Senseonics。就此計畫更新而言,我們已於 1 月 1 日將 Ascensia 美國 CGM 組織納入 Senseonics,而從第一季表現可見,該轉換進行順利。美國各地區的營運已有效運轉並展現進展。

  • We appreciate the continuing commitment of our new colleagues, and we're enjoying building our capabilities with them directly as part of one aligned team. We've continued to collaborate with Ascensia to complete the OUS transition and build a dedicated European commercial team to execute launches in Germany, Italy, Spain and Sweden.

    我們感謝新同仁持續的投入,也很高興能作為同一個一致的團隊,與他們直接共同打造我們的能力。我們也持續與 Ascensia 合作,以完成美國以外(OUS)的轉換,並建立專責的歐洲商業團隊,以在德國、義大利、西班牙與瑞典執行上市推進。

  • As mentioned earlier, we are now live in Sweden and Spain with Germany and Italy on track. As part of this, we have hired key additional roles to support those countries. We are working to finalize our business systems and to transfer the contracts, tenders and employees to within the new Senseonics organization.

    如先前所提,我們目前已在瑞典與西班牙正式上線,德國與義大利也按計畫推進。為此,我們已增聘關鍵職位以支援這些國家。我們正致力於完成商業系統的定案,並將合約、標案(tenders)與員工移轉至新的 Senseonics 組織之內。

  • We are planning to close the European transition this quarter. We've appreciated Ascensia's partnership over the past several years and their ongoing collaboration to make this transition smooth for both Eversense users, providers and commercial employees. At the same time, we recognize the value of having the full view of the product life cycle inside Senseonics, being more equipped to drive operational strategies and having the control and agility to rapidly respond to market needs.

    我們計畫在本季完成歐洲轉換的結案。我們感謝 Ascensia 過去數年來的合作夥伴關係,以及其持續協作,讓此次轉換對 Eversense 使用者、醫療提供者與商業員工而言都能順利進行。同時,我們也認知到將產品生命週期的全貌納入 Senseonics 內部的價值,使我們更有能力推動營運策略,並具備控制力與敏捷性以快速回應市場需求。

  • In addition, the full team is excited about being part of a single organization that is fully aligned and committed to building and growing the world's most advanced offering in continuous glucose monitoring. While we continue our focused work to drive awareness and adoption of 365 today, we're also excited about further shaping the future of CGM with our compelling product pipeline for tomorrow.

    此外,整個團隊也很興奮能成為單一組織的一部分,該組織完全一致並致力於打造與擴大全球最先進的連續血糖監測(CGM)方案。在我們持續專注推動 365 於今日的知名度與採用之際,我們也對於透過具吸引力的產品研發管線來進一步塑造明日 CGM 的未來感到振奮。

  • We remain on schedule to launch Gemini in the first half of 2027 as we target delivering a one-year sensor with a battery for continuous and optional on-demand readings. Moreover, in the second half of the year, we plan to initiate the first-in-human trial for Freedom, a one-year sensor with built-in Bluetooth that will connect directly to the user's phone and insulin pump without a transmitter. We've also begun the important steps of building and scaling the manufacturing processes with our manufacturing partners as we advance towards the clinical trial and ultimate launch.

    我們仍按計畫於 2027 年上半年推出 Gemini,目標是提供一款一年期感測器,搭配電池以支援連續讀值與可選的按需讀值。此外,我們計畫在今年下半年啟動 Freedom 的首次人體試驗;Freedom 為一年期感測器,內建藍牙,可在無需發射器的情況下直接連接使用者手機與胰島素幫浦。隨著我們朝臨床試驗與最終上市邁進,我們也已與製造合作夥伴開始進行建置並擴大製造流程等重要步驟。

  • Additionally, we're also working on enhancements to our Eversense 365 app. This is currently in development, and we expect that to launch later this year. The feedback that we've received during early testing has been positive, and we look forward to rolling out the app to advance our customers' diabetes management decision-making, and we're excited about advanced AI features that will be added as well.

    另外,我們也在進行 Eversense 365 應用程式的功能強化。目前仍在開發中,預期將於今年稍晚推出。我們在早期測試期間收到的回饋相當正面;我們期待推出該應用程式,以提升客戶在糖尿病管理上的決策制定,同時也對將加入的進階 AI 功能感到興奮。

  • Finally, I'd like to update you on our recent financing initiatives. Delivering on the value creation opportunity our shareholders have in Eversense requires us to have the growth capital to support these initiatives. Therefore, to position us to execute on our strategies, we took two steps to substantially strengthen our balance sheet. On Friday, we executed an amendment and expansion to our credit facility with Hercules Capital, increasing that facility from $100 million to $140 million.

    最後,我想向各位更新我們近期的融資措施。要實現股東在 Eversense 上的價值創造機會,我們需要成長資本來支持這些計畫。因此,為了讓我們能執行策略,我們採取兩項措施以大幅強化資產負債表。上週五,我們完成與 Hercules Capital 的信貸額度修訂與擴增,將該額度由 1 億美元提高至 1.4 億美元。

  • We have drawn an additional $20 million above the $35 million that was previously outstanding. And there are additional draws of up to $85 million available subject to various terms and conditions. Additionally, on Monday, we closed on a public offering raising $92 million in gross proceeds through the sale of common stock and prefunded warrants. As a result of these two financing steps, Senseonics is in a stronger position to build on the progress we are describing today.

    在先前未償還的 3,500 萬美元之上,我們已額外動用 2,000 萬美元。此外,在符合各項條款與條件的前提下,仍可再動用最高 8,500 萬美元。另外,週一我們完成一項公開發行,透過出售普通股與預付認股權證(prefunded warrants)募集 9,200 萬美元的總募集款。透過這兩項融資措施,Senseonics 更有能力在我們今天所描述的進展基礎上持續推進。

  • I'll now turn the call over to Rick to walk through the numbers.

    接下來我將把電話會議交給 Rick,請他帶大家檢視相關數字。

  • Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

    Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

  • Thanks, Tim. I'd like to begin today with an overview of our sales channels, reimbursement channels and revenue recognition to help clarify the mechanics of our financials. Now that the sales and marketing team is fully integrated into the company, I think it is important to provide additional details on what you should expect over the course of 2026.

    謝謝你,Tim。我想先從我們的銷售通路、給付/報銷通路以及收入認列的概覽開始,以協助釐清我們財務數字的運作機制。現在銷售與行銷團隊已完全整合進公司,我認為有必要提供更多細節,說明在 2026 年期間各位應可預期的情況。

  • Senseonics has three primary sales channels in the US, direct-to-consumer, health care providers and reorders. Direct-to-consumer sales is the largest US sales channel and currently accounts for approximately 60% of our new patient growth. In the second half of 2025, we made the strategic decision to invest heavily in the channel and will spend a similar amount this year at approximately $13 million. We learned a lot last year about effectively deploying and targeting this spending and have applied those learnings in 2026, resulting in lower cost per workable leads and higher conversion rates.

    Senseonics 在美國有三個主要銷售通路:直接面向消費者、醫療照護提供者,以及再訂購(reorders)。直接面向消費者的銷售是美國最大的銷售通路,目前約占我們新病患成長的 60%。在 2025 年下半年,我們做出策略性決策,大幅投資該通路,今年也將以約 1,300 萬美元投入相近金額。我們去年在如何有效部署並精準投放這些支出方面學到很多,並已將這些經驗應用於 2026 年,帶來更低的每個可行潛在客戶(workable leads)成本與更高的轉換率。

  • Our second US sales channel is health care providers targeted by our sales force. While HCP sales currently account for about 40% of new patient growth, this channel has the highest ROI due to repeat prescribers. In 2026, our sales force has continued to increase productivity, driving more and more new patient leads, and we expect this trend to continue each quarter. Last, but critical to our business is our patient reorders, which will continue to grow each year. We expect 40% of our US volume to come from reorders in 2026 and are focused on continuing to improve patient retention.

    我們在美國的第二個銷售通路是由我們的銷售團隊鎖定的醫療照護提供者(HCP)。雖然HCP銷售目前約占新病患成長的40%,但由於處方醫師的重複開立,該通路具有最高的投資報酬率(ROI)。在2026年,我們的銷售團隊持續提升生產力,帶動越來越多的新病患線索,我們預期此趨勢將在每一季延續。最後,對我們業務至關重要的是病患的再次訂購,且將在每年持續成長。我們預期2026年美國銷量的40%將來自再次訂購,並專注於持續提升病患留存率。

  • Now I'll move to US reimbursement channels and the mix of bundled pay versus durable medical equipment. In bundled pay, the insertion procedure and the Eversense 365 sensor are combined in a single payment. It is the most profitable reimbursement channel and with good support from our inside sales team, approximately 60% of our volume is now flowing through this channel. This contributed to the favorable margins we saw in Q1.

    接下來我將說明美國的給付通路,以及整合式給付(bundled pay)與耐用醫療設備(DME)的組合。在整合式給付中,植入手術與Eversense 365感測器合併為單一筆付款。這是獲利能力最高的給付通路,在我們內勤銷售團隊的良好支援下,目前約有60%的銷量正透過此通路流入。這也促成了我們在第一季看到的有利毛利率表現。

  • The remainder of the volume continues to flow through our DME reimbursement channel. The DME channel is serviced by distributors with payer contracts, and we recognize revenue upon shipment to the DME distributors. These distributors maintain appropriate levels of inventory, typically 30 days or less. We service the bundled pay channel primarily in two ways.

    其餘的銷量仍持續透過我們的DME給付通路流入。DME通路由與付款方(payer)簽有合約的經銷商提供服務,我們在出貨給DME經銷商時認列營收。這些經銷商會維持適當的庫存水位,通常為30天或更短。我們主要以兩種方式服務整合式給付通路。

  • First, through our consignment program, where participating physicians keep inventory on their shelves, so the product is readily available for patients; second, through Eon Care, our wholly owned subsidiary that utilizes contracted nurses to perform the procedure once a patient has a prescription. In the bundled pay channel, we recognize revenue at the time of the procedure. With the integration of the commercial organization, we will no longer be reporting sales to Ascensia, so our reported revenue growth will more closely align with our patient base growth. I hope these descriptions were helpful.

    第一,透過我們的寄售(consignment)計畫,參與的醫師在診所備有庫存,使產品可即時提供給病患;第二,透過Eon Care(我們的全資子公司),在病患取得處方後,運用簽約護理師執行該項手術。在整合式給付通路中,我們於手術發生時認列營收。隨著商業組織的整合,我們將不再申報對Ascensia的銷售,因此我們所揭露的營收成長將更貼近我們的病患基礎成長。希望以上說明對各位有所幫助。

  • Now let's turn to the financials for the quarter. In the first quarter of 2026, net revenue grew 85% year-over-year to $11.7 million compared to $6.3 million in the prior year period on the continued momentum of Eversense 365 new patient additions, retention rates slightly above plan and more of our business transitioning into the more profitable bundled pay reimbursement channel.

    現在讓我們來看本季的財務表現。在2026年第一季,淨營收年增85%至1,170萬美元,相較於去年同期的630萬美元;成長動能來自Eversense 365新增病患持續增加、留存率略高於計畫,以及更多業務轉向獲利能力較高的整合式給付通路。

  • US revenue for the fourth quarter was $9.3 million and revenue outside the US was $2.4 million. In Q1 2026, gross profit was $6.9 million, an increase of $5.4 million from the prior year period. This increase in gross profit was primarily due to higher US revenues driven by continued adoption of the Eversense 365 system, higher average selling prices as more of our business moves to the bundled pay channel and a more streamlined manufacturing and supply chain contributing to improved margins.

    第四季的美國營收為930萬美元,美國以外營收為240萬美元。在2026年第一季,毛利為690萬美元,較去年同期增加540萬美元。毛利增加主要來自美國營收提高(受Eversense 365系統持續採用所帶動)、隨著更多業務轉向整合式給付通路而提升的平均售價,以及更精簡的製造與供應鏈帶動毛利率改善。

  • During the quarter, we recognized a onetime benefit of $0.5 million in cost of goods sold due to the utilization of raw materials for the continued commercialization of Eversense E3 outside of the US. Excluding this onetime benefit, gross profit margins would still be above plan at approximately 54%. Research and development expenses in Q1 2026 were $8.6 million, an increase of $1.3 million compared to the prior year period. The increase was primarily due to new R&D projects, the ramp-up of new clinical trials and increased headcount to support these activities.

    本季我們在銷貨成本中認列一次性利益50萬美元,係因使用原物料以支持Eversense E3在美國以外地區的持續商業化。即使排除這項一次性利益,毛利率仍將高於計畫,約為54%。2026年第一季研發費用為860萬美元,較去年同期增加130萬美元。增加主要由於新的研發專案、新臨床試驗的加速推進,以及為支援上述活動而增加的人力。

  • First quarter 2026 selling, general and administrative expenses were $30.2 million, an increase of $22.5 million compared to $7.7 million in the prior year period, primarily driven by the integration of the commercial organization, including increased personnel, transition support services from Ascensia, direct-to-consumer marketing and other operational costs.

    2026年第一季銷售、一般及行政費用為3,020萬美元,較去年同期的770萬美元增加2,250萬美元,主要由商業組織整合所驅動,包括人員增加、來自Ascensia的轉換支援服務、直接面向消費者(DTC)行銷及其他營運成本。

  • Net loss was $32.3 million or $0.71 loss per share in the first quarter of 2026 compared to a net loss of $14.3 million or a $0.40 loss per share in the first quarter of 2025. Net loss increased by $18 million, primarily due to increased expenses resulting from the costs related to taking over the commercialization and distribution of Eversense. As of March 31, 2026, cash, restricted cash and cash equivalents totaled $64.6 million, and debt and accrued interest was $35.2 million. Q1 delivered, and we're building on that momentum.

    2026年第一季淨損為3,230萬美元,或每股虧損0.71美元;相較之下,2025年第一季淨損為1,430萬美元,或每股虧損0.40美元。淨損增加1,800萬美元,主要由於接手Eversense商業化與配送所產生的相關成本導致費用上升。截至2026年3月31日,現金、受限制現金及約當現金合計為6,460萬美元,負債及應計利息為3,520萬美元。第一季表現達標,我們正以此動能持續推進。

  • We're raising our full-year 2026 global net revenue guidance to $60 million to $64 million compared to $58 million to $62 million previously. This updated revenue range represents notable year-over-year growth of 70% to 82%. Our business is seasonal due to the resetting of patient deductibles at the beginning of the calendar year and heavier utilization of patient assistance programs at that time to offset out-of-pocket costs.

    我們將2026年全年全球淨營收指引上調至6,000萬至6,400萬美元,先前為5,800萬至6,200萬美元。更新後的營收區間代表顯著的年增幅度,約為70%至82%。由於每年年初病患自付額(deductible)重置,以及同一期間為抵銷自付費用而更頻繁使用病患協助計畫,我們的業務具有季節性。

  • The seasonality of our business, the fact that we launched Eversense 365 in the fourth quarter of 2024 and the second half focus of our investments in DTC to drive awareness in the back half of 2025 contribute to our revenue being more heavily weighted to the back half of the year. We expect to see approximately 40% of the sales in the first half of the calendar year and 60% in the second half.

    我們業務的季節性、我們於2024年第四季推出Eversense 365,以及我們在2025年下半年將DTC投資重點放在提升市場認知等因素,使得我們的營收權重更偏向年度下半年。我們預期約40%的銷售將發生在上半年,60%在下半年。

  • Taking into consideration our margin performance to date, along with the planned launch of Eversense 365 in Europe, which will allow us to focus primarily on a single product globally, we now expect full-year 2026 gross profit margin to be between 55% and 58%, increasing in the back half of the year. We are excited by the financial results in Q1, driven by the integration of the commercial organization and expect to see continued improvements in our top line and the expansion of our gross profit margins.

    綜合考量目前的毛利率表現,以及計畫在歐洲推出Eversense 365(使我們得以在全球主要聚焦單一產品),我們目前預期2026年全年毛利率將介於55%至58%,並在下半年提高。我們對第一季的財務成果感到振奮,該成果由商業組織整合所帶動;並預期營收將持續改善,毛利率亦將進一步擴張。

  • Due to the integration of the commercial organization and supporting transition service agreements from Ascensia, we expect operating expenses to be between $150 million and $160 million with increases primarily in SG&A and a smaller increase in R&D for the Gemini pivotal trial. We expect cash utilization in 2026 to be between $110 million and $120 million, largely as a result of increasing SG&A due to bringing the sales and marketing teams in-house. Earlier this week, we completed an equity financing and expanded our debt facility with Hercules Capital, adding more than $100 million to our balance sheet.

    由於商業組織整合以及Ascensia提供的轉換服務協議支援,我們預期營業費用將介於1.5億至1.6億美元,增幅主要來自SG&A,研發費用則因Gemini關鍵性試驗(pivotal trial)而小幅增加。我們預期2026年現金使用量將介於1.1億至1.2億美元,主要因將銷售與行銷團隊內部化而使SG&A增加。本週稍早,我們完成一筆股權融資,並與Hercules Capital擴增我們的債務融資額度,使資產負債表增加逾1億美元。

  • We issued common stock and prefunded warrants to institutional investors for gross proceeds of $92 million and drew an additional $20 million on our $140 million debt facility, bringing total debt outstanding to $55 million. We believe this is the right mix of debt and equity in our capital structure, and we believe we now have the financing in place to get us to the anticipated launch of the Freedom product in 2028. We're excited that our strengthened balance sheet will allow us to drive shareholder value by supporting the continued investment in Eversense 365 and future generation products while focusing on executing our commercial strategy.

    我們向機構投資人發行普通股及預付認股權證,募集總額為9,200萬美元,並在我們1.4億美元的債務融資額度下額外提取2,000萬美元,使未償還債務總額達到5,500萬美元。我們認為,這是我們資本結構中債務與股權的適當組合,並且我們相信,我們現在已具備資金,可支持我們達成預期於2028年推出Freedom產品的目標。我們很振奮,因為更強健的資產負債表將使我們能夠透過支持對Eversense 365及下一代產品的持續投資,同時專注於執行我們的商業策略,來提升股東價值。

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

    接下來,我把話筒交回給Tim。

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Thank you, Rick. To wrap up, I want to step back and frame where we stand. Senseonics entered 2026 with a clear thesis that bringing the commercial organization in-house, combined with the strength of the Eversense 365 product would unlock revenue growth and margin improvement. The first quarter results support that thesis, $11.7 million in revenue, gross margins of 58%, DTC new patient shipments nearly doubling and Eon Care now performing more than one-third of all insertions, as well, patient reorders are tracking above plan. At the same time, our balance sheet is healthy.

    謝謝你,Rick。在結束之前,我想先退一步,說明我們目前的狀況。Senseonics在2026年初提出明確的主張:將商業組織內部化,再加上Eversense 365產品的優勢,將能帶動營收成長並改善毛利率。第一季的結果支持了這項主張:營收1,170萬美元、毛利率58%、DTC新病患出貨量幾乎翻倍,且Eon Care目前已執行超過三分之一的所有植入手術;同時,病患回購也高於計畫進度。同時,我們的資產負債表也很健康。

  • Our pipeline is advancing on schedule with Gemini targeted in the first half of 2027 and Freedom on track to enter its first human trial later this year, and we have the organizational structure in place with a full US team integrated. The European transition is underway and Eon Care is scaling.

    我們的產品線(pipeline)正按計畫推進,Gemini目標在2027年上半年推出,Freedom也按進度預計於今年稍晚進入首次人體試驗;此外,我們已建立組織架構,並完成整合一支完整的美國團隊。歐洲的轉換正在進行中,Eon Care也在擴張規模。

  • We believe Senseonics is positioned to become the company that reshapes continuous glucose monitoring, and we intend to execute with the discipline and urgency that this opportunity demands. With the momentum that we are building across our commercial, development and financial initiatives, we're optimistic about the remainder of 2026 and beyond.

    我們相信,Senseonics已具備條件成為重塑連續血糖監測(CGM)的公司,我們也將以此機會所要求的紀律與緊迫感來執行。隨著我們在商業、研發與財務各項計畫上持續累積動能,我們對2026年剩餘期間及未來發展保持樂觀。

  • We look forward to speaking with many of you at our event during this year's American Diabetes Association Conference in New Orleans. With that, I'll now turn the call over to the operator to answer any questions that you may have. Thanks once again for your time today.

    我們期待在今年於紐奧良舉行的美國糖尿病協會(ADA)年會期間的活動上,與各位中的許多人交流。接下來,我將把電話交給接線員,回答各位可能有的問題。再次感謝各位今天撥冗參與。

  • Operator, let's go ahead and open up the call for questions.

    接線員,請開始開放提問。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Anthony Petrone, Mizuho Group.

    Anthony Petrone,瑞穗集團。

  • Anthony Petrone - Analyst

    Anthony Petrone - Analyst

  • Congrats to the team here. Maybe Tim and Brian, sort of a two-part question here. Ascensia coming over in the US described as a seamless transition. Just wondering, though, as you sort of put them under a new corporate umbrella, is there any like lag as to what their contribution is going to look like for turning on new sites contributing to patient growth.

    恭喜團隊。Tim和Brian,我這裡有一個兩部分的問題。Ascensia在美國的交接被形容為無縫轉換。不過我想了解的是,當你們把他們納入新的公司架構之下時,在啟動新據點、進而對病患成長做出貢獻方面,是否會有任何延遲?

  • It seems like there can be more of a tailwind certainly as this year goes on and then that follows through to the European experience. And then a follow-up here quickly would be on the cadence of investments. You're coming off the capital raise, debt and equity. Investments in regions was a gating factor. DTC drives new patients.

    看起來隨著今年推進,確實可能會有更大的順風,並且也會延伸到歐洲的經驗。接著很快追問一點,關於投資的節奏。你們剛完成資本募集,包含債務與股權。對各地區的投資曾是限制因素。DTC能帶來新病患。

  • You have the investment opportunity with the Eon inserter. So how do you look at the pace of investments? Where will they be focused kind of initially in the first half to the second half? And how meaningful do you expect a conversion in new patient growth this year from the increased investments?

    你們也有Eon植入器的投資機會。那麼你們如何看待投資步調?在上半年到下半年之間,初期會把重點放在哪些方面?而就今年因增加投資而帶來的新病患成長轉換,你們預期會有多大幅度的貢獻?

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Thanks, Anthony. In regards to the transition, I'll speak to that or at least introduce and Brian can come in. But it really has gone quite smooth, right? The sales reps were obviously -- we work with them pretty extensively in the fourth quarter, made sure they had everything they need. Even simple things like keeping the exact same cell phone numbers, all of that happened.

    謝謝你,Anthony。關於轉換,我先回應或至少先做個引介,Brian也可以補充。整體來說確實進行得相當順利。銷售代表在第四季我們就與他們密切合作,確保他們具備所需的一切。甚至像是保留完全相同的手機號碼這種小事,也都完成了。

  • So we pretty much flipped the switch on December 31, and they were calling on the same accounts, really picked up everywhere that they should have. So we don't -- we haven't seen and don't anticipate any lag in regards to their efforts and capability. Brian, I don't know if you had any further qualification for that or --

    所以我們幾乎是在12月31日就完成切換,他們隨即拜訪相同的客戶,基本上在各方面都如預期地接續運作。因此,就他們的努力與能力而言,我們沒有看到、也不預期會有任何延遲。Brian,我不確定你是否還要再補充說明,或--

  • Brian Hansen - Director, Chief Commercial Officer

    Brian Hansen - Director, Chief Commercial Officer

  • Anthony, I'd probably add to that, that on the EU side, right, for our four European countries, we're moving from the BGM sales efforts to hiring sales reps to now take over those activities. So if there's a lag, it's in our four OUS countries. But as Tim said, the US was fairly seamless.

    Anthony,我可能補充一點:在歐盟那邊,對於我們四個歐洲國家,我們正從BGM的銷售推廣模式,轉為招募銷售代表來接手這些活動。所以如果有延遲,會是在我們四個美國以外(OUS)的國家。但如Tim所說,美國這邊相當無縫。

  • Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

    Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

  • Yes. And then Anthony, I'll cover the investment question. So we stuck to our original plan. Our original plan does call for an increase in DTC spend in the back half of the year from where it is in the first half, but still in that $13 million ballpark. And we are certainly monitoring the sales force. We have 43 territories today with a plan to maintain that level and increase it next year and the following with our future generation product launches.

    是的。Anthony,接著我來回答投資的問題。我們維持原先的計畫。原先的計畫確實預期下半年DTC支出會較上半年增加,但仍大致落在1,300萬美元的區間。我們也持續監控銷售團隊。目前我們有43個銷售區域,計畫維持這個水準,並在明年及後年隨著下一代產品上市而進一步擴增。

  • Operator

    Operator

  • Josh Jennings, TD Cowen.

    Josh Jennings,TD Cowen。

  • Joshua Jennings - Analyst

    Joshua Jennings - Analyst

  • Nice to see the strong momentum here in the early part of 2026. I wanted to ask just about the stat about 60% of insertions are coming through the bundled pay channel, Tim and Rick. I mean, that's a nice higher number than we were anticipating here in the early days of 1Q '26 relative to, I think, where you exited in 2025. How do you see that mix evolving? Is that 60% kind of a steady state? Or should we be thinking that, that continues to move higher over the course of '26 and into 2027 with it being kind of, I think, a higher revenue, higher-margin channel?

    很高興看到2026年初期展現強勁動能。我想請教一個數據:大約60%的植入是透過bundled pay通路完成的,Tim和Rick。我的意思是,相較於你們在2025年結束時的狀況,這在2026年第一季初期是個比我們預期更高的比例。你們如何看待這個組合的演變?60%會是一個穩態水準嗎?或者我們應該預期在2026年、甚至進入2027年,這個比例會持續提高,因為這似乎是一個營收更高、毛利更高的通路?

  • Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

    Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

  • Yes, you're right. Historically, we've been about 50-50 DME and bundled pay. And we certainly have focused some of our DTC spending and inside sales efforts on that bundled pay channel. So we were pretty excited as that our channel mix moved to that channel being more profitable, which was a good piece of the reason we saw the upside in our margins. We're going to keep focusing on that channel over the course of the year. But right now, thinking that the 60/40 is an appropriate target.

    是的,你說得對。過去我們大約是DME與bundled pay各半。而我們確實把部分DTC支出與內勤銷售(inside sales)的努力,聚焦在bundled pay通路上。因此我們很振奮看到通路組合轉向更有利可圖的通路,這也是我們毛利率出現上行的一個重要原因。我們會在今年持續聚焦這個通路。但就目前而言,我們認為60/40是一個合適的目標。

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Yes. As Rick is pointing out, Brian's team is doing a great job to reaching out to the folks that are on Medicare, which is a pretty good portion of that. But we are also seeing some of the commercial payers transition to the bundled pay. So, Josh, I would expect that to transition, but over a couple of year time period. I don't think it's anything that will have precipitously in this year.

    是的。正如 Rick 所指出的,Brian 的團隊在主動接觸使用 Medicare 的族群方面做得非常出色,而這部分占比相當可觀。但我們也看到部分商業保險支付方正在轉向採用打包式支付(bundled pay)。所以,Josh,我預期這會逐步轉換,但會是在接下來幾年的時間尺度上。我不認為今年會有任何突然發生的變化。

  • Joshua Jennings - Analyst

    Joshua Jennings - Analyst

  • Maybe a follow-up, just a two-part pipeline question. The first part, just thinking about the data that hit at ATTD with the Sequel integration and what will be put forward at ADA just on the performance of Eversense 365. There may be some other pump partners that are interested in integrating Eversense 365 here. Any updates on any partnership discussions?

    也許追問一下,關於管線的兩段式問題。第一部分,想請教在 ATTD 上釋出的 Sequel 整合相關數據,以及在 ADA 上將提出的 Eversense 365 表現數據。可能還會有其他胰島素幫浦合作夥伴有興趣在這裡整合 Eversense 365。關於任何合作討論,有沒有最新進展?

  • And then also just with the Freedom progress and getting into a human trial in the second half of this year, maybe just help us think about how derisked that program is? Are there any further steps that need to be taken before you guys can move into that trial? I guess what boxes are left to be checked before the trial can kick off?

    另外,關於 Freedom 的進展,以及今年下半年進入人體試驗,能否幫我們理解這個專案目前去風險(derisked)的程度?在你們能夠進入該試驗之前,是否還需要完成任何進一步步驟?也就是說,在試驗啟動前,還有哪些項目需要勾選完成?

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Sure, Josh. On the first part on the the data that Fran is going to speak to. That's going to be an extension of the work that she did. We now have a notably much larger population of the Sequel folks. We're seeing really encouraging results there.

    當然可以,Josh。第一部分關於 Fran 將要談到的數據。那會是她先前工作的延伸。我們現在擁有明顯更大規模的 Sequel 使用者族群。我們看到的結果非常令人鼓舞。

  • She did get an oral presentation. We'll also have a lot more extension of the 365 data. So that will be encouraging, and we're looking forward to the results from that. On the pump partnership, we continue to be very active. We don't have anything to announce, but it is an important focus for us, and we're continuing to make progress. On Freedom?

    她也獲得了一場口頭報告的機會。我們也會有更多 365 數據的延伸結果。所以那會是令人振奮的,我們也很期待那些結果。至於幫浦合作夥伴關係,我們持續非常積極推進。目前沒有任何可以宣布的內容,但這是我們的重要重點,我們也在持續取得進展。至於 Freedom 呢?

  • Mukul Jain - Chief Operating Officer

    Mukul Jain - Chief Operating Officer

  • Josh, this is Mukul. On Freedom, we have been making a lot of progress. We are doing a second preclinical in animals. And now we think we are at a stage where we've taken the risk out of the product and take it into humans. The first-in-human, we'll be doing outside US in a feasibility study. And then we'll bring the data over to start discussions with FDA to get a pivotal study, IDE in by end of the year.

    Josh,我是 Mukul。關於 Freedom,我們已經取得了很多進展。我們正在進行第二項動物的臨床前研究。現在我們認為已經到了把產品風險降下來、並推進到人體的階段。首次人體試驗(first-in-human)我們會在美國以外地區,以可行性研究(feasibility study)的形式進行。接著我們會把數據帶回來,開始與 FDA 討論,目標是在年底前提交關鍵性試驗(pivotal study)的 IDE。

  • Operator

    Operator

  • Matt Miksic, Barclays.

    Barclays 的 Matt Miksic。

  • Matthew Miksic - Analyst

    Matthew Miksic - Analyst

  • Congrats on a really great quarter. I had one question on just sort of like the retention of some of the folks using the system and then one on sort of the next-gen technology platform power enhancements that you've made because it's a question that I get fairly often from investors. So the first, you've talked about sort of like the percentage of folks that will renew the first time, the second time and the third time.

    恭喜你們交出非常出色的一季。我有一個問題是關於使用系統的部分患者留存率,另外一個是關於你們在下一代技術平台電源強化方面所做的改進,因為投資人常常問我這個問題。第一個,你們談過大概有多少比例的使用者會在第一次、第二次、第三次進行續用。

  • And I'm wondering now that you're a year in change in on 365, if you're seeing any changes in that or improvements in that just because I think that was like a six-month statistic before. Just wondering if that's changing at all? And then I have a quick follow-up.

    我想問的是,現在 365 推出已經一年多了,你們是否看到這些數字有任何變化或改善?因為我記得那之前像是以六個月為統計基礎。想了解這是否有任何改變?然後我還有一個簡短的追問。

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Yes. Obviously, we don't have the multi sensors at this point, but we are encouraged. The historical has been first to second is around 75%, second to third is around 85%. By the time you get to your third sensor, it's well into the 90s. And I think we're continuing on that track. We don't yet have the data, obviously, for the second year, but the first data is quite encouraging and frankly, was a little bit stronger than we had modeled. So we feel quite good about the experience we're seeing in the one-year sensor. What was the question on battery powering?

    是的。顯然我們目前還沒有多顆感測器的數據,但我們感到鼓舞。歷史上,從第一顆到第二顆大約是 75%,第二顆到第三顆大約是 85%。等到你用到第三顆感測器時,留存率就已經遠超過 90%。我認為我們仍在沿著這個軌跡前進。我們當然還沒有第二年的數據,但第一批數據相當令人鼓舞,而且坦白說,比我們模型預估的還要更強一些。所以我們對一年期感測器所呈現的使用體驗感到相當有信心。你關於電池供電的問題是什麼?

  • Mukul Jain - Chief Operating Officer

    Mukul Jain - Chief Operating Officer

  • He was going to ask the question to follow-up.

    他本來要追問下一個問題。

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Did you have a question on the battery, Matt?

    Matt,你有關於電池的問題嗎?

  • Matthew Miksic - Analyst

    Matthew Miksic - Analyst

  • Yes. Sorry about that. Yes, I accidentally put myself back on mute. Yes. Just maybe talk about how to think about the sort of level of work that you've done so far on sort of the next-gen battery platform, what maybe the technology risk is to that or the manufacturing risk or how to frame that just given that it's the next big thing in the pipeline?

    有的。不好意思。是的,我不小心又把自己設回靜音了。是的。能否談談你們目前在下一代電池平台上已完成的工作程度、可能的技術風險或製造風險,或是該如何看待這件事?畢竟這是管線中下一個重大項目。

  • Mukul Jain - Chief Operating Officer

    Mukul Jain - Chief Operating Officer

  • Sure, Matt. So the battery comes from Integer, right, that they're pretty much the only manufacturer of implantable batteries for all medical devices. So there's no technological risk. The chemistry we are using is very well-known in the cardiac and neuromodulation devices used over two decades. And all those choices were made just to make sure that the risk is low.

    當然可以,Matt。電池是由 Integer 提供的,對吧?他們幾乎是所有醫療器材植入式電池的唯一製造商。所以沒有技術風險。我們使用的化學體系在心臟與神經調控裝置中已使用超過二十年,非常成熟。而所有這些選擇都是為了確保風險很低。

  • FDA knows that company pretty well. So for Gemini, we have already attached the battery. We already have it in clinical study. So there is no technical risk left in Gemini. Going beyond the battery is the Bluetooth that comes new to Freedom, and we have made a lot of progress there. And as we have stated earlier, we are ready to go into humans to kind of start collecting data while we continue to refine the Bluetooth technology in that really small form factor.

    FDA 也非常熟悉那家公司。因此就 Gemini 而言,我們已經把電池裝上去了。也已經在臨床研究中使用。所以 Gemini 在技術風險上已經沒有剩餘。超出電池之外,Freedom 新增的是藍牙功能,而我們在這方面已取得很大進展。正如我們先前所說,我們已準備好進入人體試驗,一邊開始收集數據,一邊持續在那個非常小的尺寸規格下精進藍牙技術。

  • Operator

    Operator

  • Sean Lee, H.C. Wainwright.

    H.C. Wainwright 的 Sean Lee。

  • Sean Lee - Analyst

    Sean Lee - Analyst

  • In the prepared remarks, you mentioned that DTC is becoming an increasing larger piece of the new patient adds. So I was wondering, have you seen any changes in the cost per patient out through these channels pre and post the Ascensia transition? And what point do you think we can get to once it's fully ramped up?

    在事先準備的發言中,你提到 DTC 正成為新增患者中占比愈來愈大的來源。所以我想問,在 Ascensia 轉換前後,你們是否看到透過這些通路取得每位患者的成本有任何變化?以及你認為在完全拉升(fully ramped up)之後,我們大概能達到什麼水準?

  • Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

    Frederick Sullivan - Chief Financial Officer, Treasurer, Secretary

  • Yes, sure, Sean. I'll take that. So I think if you remember, the back half of 2025, we made significant investment in DTC, certainly drove increased awareness of our product, but those cost per workable leads were higher, it did become a little bit less efficient. And so, in 2026, what we did is take the same amount of spend that we spent in the back half of '25 and spread it all year long. And so although we're making smaller investments on a monthly basis, we're seeing improvements in both cost per workable lead and in our conversion rates.

    好的,當然可以,Sean。我來回答。我想如果你還記得,在 2025 年下半年,我們在 DTC 上做了顯著投資,確實提升了產品知名度,但每個可用線索(workable lead)的成本更高,效率也確實變得稍微差一些。因此在 2026 年,我們做的是把 2025 年下半年同樣的支出金額,分攤到全年。所以雖然我們每月投入較小,但我們看到每個可用線索成本與轉換率兩方面都有所改善。

  • So we've learned a lot with that investment we made in the back half of the year and are certainly tweaking algorithms and spend levels to make sure that it's extremely efficient. So we're pretty happy with the progress we've made so far in Q1.

    因此,我們從今年下半年所做的那項投資中學到了很多,並且確實正在微調演算法與支出水準,以確保其極具效率。所以,我們對目前在第一季所取得的進展感到相當滿意。

  • Sean Lee - Analyst

    Sean Lee - Analyst

  • Great to hear that. And with the competition that Dexcom and others are coming up with these long next-gen short durations. Again, how do you defend the value proposition of Eversense 365 versus these other sensors that are coming in and potentially lower price points?

    很高興聽到。另外,面對 Dexcom 以及其他競爭對手推出這些新一代、較短配戴週期但仍屬長效的產品。再請教一次,你們如何捍衛 Eversense 365 相較於這些即將上市、且可能具備更低價格帶的其他感測器之價值主張?

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • The value proposition for Eversense continues to be the same. They have made some changes from 14 to 15 days, but obviously, that's significantly different than a year-long sensor. The primary premise, of course, a person with diabetes is they'd like to think less about their diabetes technology and more about the rest of their lives. So as we manufacturers can make it simpler and easier to use, they will reward you for the purchase of a quality product. And Eversense certainly fits that bill.

    Eversense 的價值主張仍然相同。他們把配戴天數從 14 天改到 15 天,但顯然,這與一年期感測器有著顯著差異。當然,核心前提是:糖尿病患者希望把更少心力放在糖尿病科技上,而把更多心力放在生活的其他面向。因此,作為製造商,我們若能讓產品更簡單、更容易使用,消費者就會以購買高品質產品來回饋你。而 Eversense 無疑符合這一點。

  • So a year-long, I'm not having to think about a sensor change is really very attractive to people, and that's why we're seeing the growing penetration that we're seeing.

    因此,一年期、我不必去想要更換感測器,對人們來說確實非常有吸引力,這也是我們看到滲透率持續提升的原因。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Ben Haynor, Lake Street Capital Markets.

    Ben Haynor,Lake Street Capital Markets。

  • Benjamin Haynor - Analyst

    Benjamin Haynor - Analyst

  • First off for me, just thinking about some of the data that you presented at the ATTD conference on the first 5,355 patients. You have really good time and range, really good GMI look better than what a lot of competitors have published both on the CPM and CGM pump side. Can you talk about whether that got much attention or kind of any color on how that was received at that conference?

    我先從你們在 ATTD 會議上所展示的前 5,355 名患者資料談起。你們的目標範圍內時間(time in range)表現非常好,GMI 也看起來優於許多競爭對手在 CPM 與 CGM 幫浦端所發表的數據。你能談談這是否引起了很多關注,或是在會議上大家對此的反應如何嗎?

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • Yes. We've actually received quite nice feedback from it. I think one of the things is, we'll have an extension on that at the ADA that I think will get further coverage, but we've also been in the process of getting that peer-reviewed -- written up and peer-reviewed. And that's really the next big step for us to get further visibility of it. So I would hope that later this summer, we'll have a peer-reviewed publication that will strengthen the publication and rollout of that information.

    是的。我們確實收到了相當不錯的回饋。我想其中一點是,我們會在 ADA 會議上對此做延伸,我認為會獲得更多報導;同時,我們也正在把這些內容整理成文並送交同儕審查(peer-reviewed)。而這正是我們下一個重要步驟,以提升其能見度。因此,我希望在今年夏末,我們能有一篇同儕審查的出版物,來強化這些資訊的發表與推廣。

  • But the feedback certainly has been positive. As we pointed out, we feel very comfortable. You get the long-term compliance, obviously, of Eversense at 365 days. And the algorithm, the loop algorithm has some pretty attractive attributes and is performing pretty well. So when you put those together with our high-precision pump like you get out of Sequel, you get those very, very good results.

    但回饋確實是正面的。如同我們所指出的,我們感到非常有信心。你能獲得 Eversense 365 天所帶來的長期依從性(compliance)。而演算法、閉環演算法也具備一些相當吸引人的特性,且表現相當不錯。因此,當你把這些與 Sequel 所提供的高精準度幫浦結合在一起,就能得到非常、非常好的結果。

  • Benjamin Haynor - Analyst

    Benjamin Haynor - Analyst

  • Excellent. And then, I guess, this kind of dovetails with one of Josh's questions on that -- the data that was with the first 100 or whatever was Sequel pump users was -- does that help the level of attention and maybe get some of the other potential pump partners across the finish line? Or is that not enough patients yet or how is the right way to think about that?

    很好。接著我想,這也呼應 Josh 其中一個問題——那份包含前 100 位左右 Sequel 幫浦使用者的資料——是否有助於提升關注度,並可能讓其他潛在的幫浦合作夥伴更接近拍板?還是說患者數仍不夠多?應該如何正確看待這件事?

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • I mean, it's definitely helping with the partnership. Brian, do you want to speak to that? Your team is spending a lot of time working with them.

    我的意思是,這肯定有助於合作夥伴關係。Brian,你要不要談談?你的團隊花了很多時間在和他們合作。

  • Brian Hansen - Director, Chief Commercial Officer

    Brian Hansen - Director, Chief Commercial Officer

  • Yes. I think both the success we've had in the first couple of months of the combined system has opened some eyes and exceeded our expectations. And clearly, the data was good, both on the sensor and the sensor and the pump. And so, any time you can show that data in real life now, it substantiates a whole lot. It just helps a lot of conversations, Ben. So very happy with it. And yes, it's helping the conversations move forward.

    是的。我認為,我們在前幾個月的整合系統所取得的成功,確實讓一些人眼睛一亮,也超出我們的預期。而且數據很不錯,無論是感測器本身,或是感測器與幫浦的整體表現。因此,任何時候你能在真實世界情境中展示這些數據,都能大幅佐證許多事情。Ben,這確實對很多對話很有幫助。所以我們對此非常滿意。而且是的,這正在幫助對話持續往前推進。

  • Operator

    Operator

  • And this does conclude the Q&A portion of today's event. I would now like to turn back to CEO, Tim Goodnow, for any additional or closing remarks.

    今天活動的問答環節到此結束。接下來我想把時間交回給執行長 Tim Goodnow,請他做任何補充或結語。

  • Timothy Goodnow - President, Chief Executive Officer, Director

    Timothy Goodnow - President, Chief Executive Officer, Director

  • I'd like to thank everybody for participating, and we look forward to updating you next quarter. So with that, we'll go ahead and end the call. Thank you.

    我要感謝各位的參與,我們期待在下個季度向各位更新進展。那麼,我們就到此結束本次電話會議。謝謝。

  • Operator

    Operator

  • Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

    謝謝。今天的會議到此結束。感謝各位撥冗與會並參與。您現在可以掛線。