Senseonics Holdings Inc (SENS) 2024 Q3 法說會逐字稿

Good day, everyone and welcome to the Senseonics' third-quarter 2024 earnings call. (Operator Instructions) Please note this call may be recorded. I will be standing by if you should need any assistance.

大家好，歡迎參加 Senseonics 2024 年第三季財報電話會議。（操作員指示）請注意，此通話可能會被錄音。如果您需要任何幫助，我將隨時待命。

It is now my pleasure to turn the conference over to Jeremy Feffer. LifeSci Advisors.

現在我很高興將會議交給傑里米·費弗。生命科學顧問。

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，請允許我提醒您，該公司的言論包括前瞻性陳述。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、公司業績和其他事項的預期，並且僅代表截至本文發布之日的觀點。這些前瞻性陳述涉及許多風險和不確定性。

A list of these 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, 2023, our quarterly report on Form 10-Q for the quarter ended September 30, 2024, and our other reports filed with the SEC. These documents are available in 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.

這些因素可能導致實際結果與任何前瞻性陳述所表達或暗示的結果有重大差異，其詳細清單載於「風險因素」部分以及我們截至 2023 年 12 月 31 日的年度報告 10-K 表、截至 2024 年 9 月 30 日的季度報告 10-Q 表以及我們向美國證券交易委員會提交的其他報告中。這些文件可在我們網站 www.senseonics.com 的「投資者關係」部分查閱。除法律要求外，我們不承擔因任何原因公開更新或修改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. Today, we also have Brian Hansen, President of CGM at Ascensia Diabetes Care, our global distribution partner for Eversense, joining us.

今天與我一起出席的還有 Senseonics 總裁兼執行長 Tim Goodnow 和財務長 Rick Sullivan。今天，我們也邀請了 Eversense 全球分銷合作夥伴 Ascensia Diabetes Care 的 CGM 總裁 Brian Hansen 加入我們。

With that, I would like to turn the call over to Tim Goodnow, President and CEO. Tim?

說到這裡，我想把電話轉給總裁兼執行長 Tim Goodnow。提姆？

Thank you, Jeremy, and thank you all for joining us this afternoon. During our call today, we'll begin with a recap of what an exciting and pivotal quarter it has been for Senseonics. We'll also hear from Brian, who is responsible for the rollout of our recently approved Eversense 365, the world's first and only 1-year continuous glucose monitor. Lastly, Rick will review our third quarter financials, and then we'll take any questions you might have.

謝謝你，傑里米，也謝謝大家今天下午加入我們。在今天的電話會議中，我們首先回顧一下對於 Senseonics 來說這是一個多麼令人興奮和關鍵的一個季度。我們還將聽取 Brian 的發言，他負責推出我們最近批准的 Eversense 365，這是世界上第一台也是唯一一台 1 年連續血糖監測儀。最後，里克將審查我們第三季的財務狀況，然後我們將回答您可能提出的任何問題。

On September 17, we received FDA approval for the Eversense 365, marking a significant accomplishment many years in the making. When we designed our 90-day and 180-day CGM products, we were always working towards the goal of one CGM for one year, a goal that seemed imposing at the time. We did the market research and knew what patients and prescribers wanted: convenience, flexibility and longevity, coupled with accuracy and reliability. We set out to deliver all of these things to help people overcome common frustrations and interruptions experienced with traditional short-term CGMs.

9 月 17 日，我們獲得了 FDA 對 Eversense 365 的批准，這是我們多年來取得的重大成就。當我們設計 90 天和 180 天的 CGM 產品時，我們始終致力於實現一年一個 CGM 的目標，這個目標在當時似乎很艱鉅。我們做了市場調查，知道病人和處方者想要什麼：方便、靈活、持久，以及準確性和可靠性。我們致力於提供所有這些服務，以幫助人們克服傳統短期 CGM 所遇到的常見挫折和乾擾。

Early feedback we've received from patients and clinicians is extremely positive, and the lead generation that we have seen in the first month of the launch has well exceeded expectations. In the first week alone, we saw the highest influx of leads in the company's history, indicating that the diabetes community is embracing Eversense 365.

我們從患者和臨床醫生那裡收到的早期回饋非常積極，而且我們在推出的第一個月看到的潛在客戶開發已經遠遠超出了預期。僅在第一周，我們就看到了公司歷史上最高的潛在客戶湧入量，這表明糖尿病社群正在接受 Eversense 365。

And as you may have heard during our KOL call a couple of weeks ago, endocrinologists see the opportunity for Eversense 365 across type 1 and type 2 diabetes. Doctors Ahn and Ciaramita also agreed that for some people with diabetes, Eversense 365 is the only CGM that makes sense. For example, patients with difficulty hearing audible sensor alarms, patients with allergies to common adhesive materials used with short-term CGMs and patients who are physically active and tend to lose sensors before the end of their stated expiration date.

正如您可能在幾週前我們的 KOL 電話會議中聽到的那樣，內分泌學家看到了 Eversense 365 在治療 1 型和 2 型糖尿病方面的機會。Ahn 醫生和 Ciaramita 醫生也同意，對於一些糖尿病患者來說，Eversense 365 是唯一有意義的 CGM。例如，難以聽到聲音感測器警報的患者、對短期 CGM 使用的常見黏合材料過敏的患者以及身體活躍且容易在規定有效期結束前丟失感測器的患者。

During the KOL event, we also heard from Mercy, the first hospital system to adopt Eversense 365 as part of a system-wide solution. Mercy with over 30,000 patients who could benefit from a CGM believes that Eversense will improve outcomes for patients as well as decrease overall costs related to diabetes care. We believe that the Mercy collaboration can bring a model for other health care systems to follow, and we hope to enter into additional similar collaborations with other health systems in the coming year.

在 KOL 活動期間，我們也聽取了 Mercy 的意見，這是第一個採用 Eversense 365 作為系統範圍解決方案一部分的醫院系統。Mercy 擁有超過 30,000 名可從 CGM 中受益的患者，該公司相信 Eversense 將改善患者的治療效果並降低與糖尿病護理相關的整體成本。我們相信 Mercy 合作可以為其他醫療保健系統樹立一個榜樣，我們希望在未來一年與其他醫療系統進行更多類似的合作。

By offering Eversense 365 to its participants and arranging access to our remote patient monitoring program, health systems can offer patients more ongoing support than providing a CGM device alone as RPM leverages personal data to inform diabetes counselors who can proactively advise patients on improving their diabetes management. These professionals are intended to provide coaching and insight into things impacting patients' glucose levels, such as medications, foods, exercise and lifestyle. And that will allow patients to make better informed decisions.

透過向參與者提供 Eversense 365 並安排存取我們的遠端患者監控程序，醫療系統可以為患者提供比單獨提供 CGM 設備更持續的支持，因為 RPM 利用個人資料來通知糖尿病諮詢師，他們可以主動建議患者改善他們的糖尿病管理。這些專業人員旨在提供指導並深入了解影響患者血糖水平的因素，例如藥物、食物、運動和生活方式。這將使患者能夠做出更明智的決定。

And the program is designed to coach and interact with patients between physician visits. This is intended to shorten the feedback loop of information patients receive. Our goal is for the Eversense CGM and RPM offerings to help health systems improve diabetes management and reduce the cost of care.

該計劃旨在在醫生就診期間對患者進行指導和互動。這是為了縮短患者接收訊息的回饋迴路。我們的目標是透過 Eversense CGM 和 RPM 產品幫助醫療系統改善糖尿病管理並降低照護成本。

On the reimbursement side, Eversense 365 is covered by nearly all US private insurers as well as Medicare, covering over 300 million lives in aggregate. We have seen strong adoption by commercial payers and continue to work with a few smaller regional insurers to expand coverage as broadly as possible.

在報銷方面，Eversense 365 幾乎涵蓋了美國所有私人保險公司以及醫療保險，總計涵蓋超過 3 億人。我們看到商業付款人的大力採用，並繼續與一些較小的區域保險公司合作，盡可能擴大覆蓋範圍。

I'm so proud of the Senseonics team and all the hard work put into delivering the world's first and only one-year CGM, but our work doesn't stop here. Our pipeline includes the Gemini sensor incorporating battery power for continuous 24/7 readings as well as the Freedom sensor, which communicates directly with the patient's phone with no transmitter required. We're making progress in our development programs to integrate these exciting enhancements into the Eversense system, and we continue our mission to improve the patient experience and reduce life disruptions that glucose monitoring can cause.

我為 Senseonics 團隊以及為提供世界上第一個也是唯一一個一年期 CGM 所付出的所有努力感到非常自豪，但我們的工作並不止於此。我們的產品線包括採用電池供電、可全天候連續讀數的 Gemini 感測器，以及無需發射器即可直接與患者手機通訊的 Freedom 感測器。我們的開發項目正在取得進展，將這些令人興奮的增強功能整合到 Eversense 系統中，我們將繼續我們的使命，改善患者體驗並減少血糖監測可能造成的生活干擾。

Lastly, Eversense 365 has been granted the designation of an integrated continuous glucose monitoring system, recognizing its accuracy and meaning that it can communicate with and be integrated into automated insulin delivery systems. We continue to work with insulin pump manufacturers towards developing the necessary interface to seamlessly pair the two systems, creating a closed loop for the ultimate diabetes care. We look forward to providing updates on the developments of these pump interfaces in the coming quarters.

最後，Eversense 365 被授予整合連續血糖監測系統的稱號，以認可其準確性，並意味著它可以與自動胰島素輸送系統通訊並整合到其中。我們繼續與胰島素幫浦製造商合作，開發必要的介面，以無縫配對兩個系統，為最終的糖尿病護理創建一個閉環。我們期待在未來幾季內提供有關這些幫浦介面開發的最新資訊。

Now as we pivot to our US launch execution and making Eversense 365 available to as many patients as possible, we'd like you to hear from Brian Hansen, President of CGM at Ascensia Diabetes Care. Brian is here with us today to provide additional information on the Eversense 365 launch strategy and the execution to date. Brian?

現在，隨著我們轉向在美國推出 Eversense 365 並讓盡可能多的患者可以使用它，我們希望您聽聽 Ascensia Diabetes Care 的 CGM 總裁 Brian Hansen 的意見。Brian 今天在這裡向我們提供有關 Eversense 365 發布策略和迄今為止執行情況的更多資訊。布賴恩？

Thanks, Tim, and thanks for asking me to participate in your call today. At Ascensia, we are equally excited to be offering the Eversense 365 product as part of our glucose monitoring portfolio. Since we began this partnership with Senseonics in 2020, they have continued to disrupt the landscape with novel differentiated products. Eversense 365 is the most recent example, providing a significant breakthrough in diabetes technology and management.

謝謝，提姆，也謝謝你邀請我參加今天的電話會議。在 Ascensia，我們同樣很高興能夠提供 Eversense 365 產品作為我們血糖監測產品組合的一部分。自 2020 年我們與 Senseonics 開始合作以來，他們不斷以新穎的差異化產品顛覆市場格局。Eversense 365 就是最新的例子，它在糖尿病技術和管理方面取得了重大突破。

For those of you unfamiliar with Ascensia Diabetes Care, we are a global company based in Basel, Switzerland of approximately 1,700 employees working in 31 countries, entirely dedicated to improving the health and lives of those with diabetes. Ascensia's products are sold in more than 125 countries worldwide, including through multiple channels here in the United States and Canada. We have helped people manage their diabetes for more than 80 years and are proud to be the global distribution partner for Senseonics.

對於不熟悉 Ascensia Diabetes Care 的人來說，我們是一家總部位於瑞士巴塞爾的全球性公司，在 31 個國家/地區擁有約 1,700 名員工，致力於改善糖尿病患者的健康和生活。Ascensia 的產品銷往全球 125 多個國家，包括透過美國和加拿大的多種管道。80 多年來，我們一直幫助人們管理糖尿病，並很自豪能夠成為 Senseonics 的全球分銷合作夥伴。

Our approach to building a successful Eversense 365 launch has been to utilize multiple marketing channels. We have a very experienced team here in the United States exclusively promoting only the Eversense 365 system. This group that I lead has dedicated independent resources to drive Eversense expansion.

我們成功推出 Eversense 365 的方法是利用多種行銷管道。我們在美國擁有一支經驗豐富的團隊，專門推廣 Eversense 365 系統。我所領導的這個團隊擁有專門的獨立資源來推動 Eversense 的擴張。

Secondly, we have created a network of approximately 800 certified doctors and nurse practitioners to insert the sensor for US patients with approximately 3,000 prescribers who can help patients start on Eversense 365. This network is in addition to Eon Care Services, which Senseonics has created to support patient access with plans to build and grow the inserter network the nurse practitioner group established. This network currently provides in-home and clinic placement of sensors by nurse practitioners in approximately 35 US geographies with plans to expand access as we drive adoption.

其次，我們建立了一個由大約 800 名經過認證的醫生和執業護士組成的網絡，為美國患者插入感測器，並有大約 3,000 名處方人員可以幫助患者開始使用 Eversense 365。該網路是 Eon Care Services 的補充，Senseonics 創建該網路是為了支持患者訪問，並計劃建立和擴展護理師團體建立的插入器網路。該網路目前為美國約 35 個地區的執業護理師提供在家中和診所放置感測器的服務，並計劃隨著我們推動採用而擴大使用範圍。

We are also employing traditional and digital marketing strategies with direct-to-consumer ad campaigns as well as health care provider educational tools. And as Tim mentioned earlier, we are enhancing our resources for future hospital system integrations. We believe this multipronged approach to building brand awareness will enable Ascensia to reach a broader Eversense 365 potential customer base, driving sales while building a comprehensive catalog of patient experiences.

我們也採用傳統和數位行銷策略，包括直接面向消費者的廣告活動以及醫療保健提供者教育工具。正如蒂姆之前提到的，我們正在增強資源，以用於未來的醫院系統整合。我們相信，這種多管齊下的品牌知名度提升方法將使 Ascensia 能夠接觸到更廣泛的 Eversense 365 潛在客戶群，在建立全面的患者體驗目錄的同時推動銷售。

To get a bit more granular for a moment, our immediate priorities include increasing awareness through optimizing our creative efforts and targeting to cost effectively drive high-quality prospects to the Ascensia website. Our website has been fully updated to allow easier navigation for better access to product information, education, training and cost and insurance details. These improvements are designed to help increase lead capture for qualified high-scoring prospects, nurturing and expanding outreach approaches to leads to better reach them and optimizing end-to-end processes and training to improve customer experience and drive conversion. As a result of these efforts, we saw health care provider and our direct-to-consumer leads increased by more than 200% in the 4 weeks post 365 approval compared to the 4 weeks prior to approval.

更詳細地說，我們的當務之急包括透過優化我們的創意工作來提高知名度，並以經濟有效的方式吸引高品質的潛在客戶造訪 Ascensia 網站。我們的網站已全面更新，以便更輕鬆地導航，從而更好地獲取產品資訊、教育、培訓以及成本和保險詳細資訊。這些改進旨在幫助提高合格高分潛在客戶的獲取率，培育和擴大潛在客戶的推廣方式以更好地接觸他們，並優化端到端流程和培訓，以改善客戶體驗並推動轉換。透過這些努力，我們發現，與批准前 4 週相比，365 批准後的 4 週內，醫療保健提供者和直接面向消費者的銷售線索增加了 200% 以上。

Speaking of customer experience, I want to share with you some of what we've been hearing in the field. First of all, the primary reaction we've seen and heard is enthusiasm. We believe we have the best product in the world, and our reps are tremendously excited to carry Eversense 365 in their bag. Secondly, we are seeing real enthusiasm from our health care providers. As I mentioned earlier, the referrals of new patients have more than doubled in addition to encouraging those using the 180-day sensor to transition to 365 when their 6-month sensor has expired.

說到客戶體驗，我想與大家分享我們在該領域聽到的一些消息。首先，我們看到和聽到的主要反應是熱情。我們相信我們擁有世界上最好的產品，我們的代表非常高興能夠攜帶 Eversense 365。其次，我們看到醫療保健提供者的真正熱情。正如我之前提到的，除了鼓勵那些使用 180 天感測器的患者在 6 個月感測器到期後過渡到 365 天感測器之外，新患者的轉診數量也增加了一倍以上。

This is opening doors to us where we've had little to no access. Lastly, I've seen many successful as well as some not so successful launches in the diabetes space, and the buzz and buildup around this one certainly has me excited.

這為我們打開了以前幾乎無法進入的大門。最後，我看過糖尿病領域許多成功的產品，也看過一些不太成功的產品，而圍繞這一產品的熱議和積累無疑讓我感到興奮。

There is one other aspect of Eversense 365 that I know will resonate extremely well with both patients and physicians, reduced calibrations. Once-weekly calibration is a marked improvement over previous Eversense generations and now does not differ much from the transdermal insertion necessary with short-term CGMs that are replaced every 10 to 14 days. I believe the reduced calibration requirement will make the Eversense 365 a much more competitive offering, and early feedback confirms our market research that once-a-week calibration should benefit Eversense adoption, particularly given the enormous convenience benefit of a year-long sensor.

我知道 Eversense 365 的另一個方面會引起患者和醫生的強烈共鳴，那就是減少校準。每週一次的校準比前幾代 Eversense 有了顯著的改進，現在與每 10 到 14 天更換一次的短期 CGM 所需的透皮插入沒有太大區別。我相信減少校準要求將使 Eversense 365 成為更具競爭力的產品，早期回饋證實了我們的市場研究，即每週一次的校準應該有利於 Eversense 的採用，特別是考慮到長達一年的感測器帶來的巨大便利優勢。

As I mentioned, Ascensia is proud to partner with Senseonics to make Eversense 365 available to patients globally. We believe in the product and its potential to improve both the experience and the outcomes for patients with diabetes. With that, I'll hand it back over to Tim.

正如我所提到的，Ascensia 很榮幸與 Senseonics 合作，讓全球患者都能使用 Eversense 365。我們相信該產品具有改善糖尿病患者體驗和治療效果的潛力。說完這些，我就把它交還給提姆。

Thank you, Brian. It's great to have you here and thanks for your invaluable efforts to date.

謝謝你，布萊恩。很高興您能來這裡，並感謝您迄今為止所做的寶貴努力。

To follow on Brian's comments in terms of the actual commercial launch, I want to remind everyone that the first commercial insertion of Eversense 365 took place in early October. And we are just beginning to ship 365 sensors into the channel more recently. As a result, third quarter revenue we are reporting today is all pre-Eversense 365. Fourth quarter US revenue will be a mix of E3 sales from its final shipments and the initial shipments of 365, meaning we will not see the full impact of 365 revenue in the US until Q1 2025.

為了跟進 Brian 關於實際商業發布方面的評論，我想提醒大家，Eversense 365 的首次商業投放是在 10 月初進行的。我們最近才開始向通路運送 365 個感測器。因此，我們今天報告的第三季收入全部來自 Eversense 365 之前的收入。第四季美國的收入將是 E3 最終出貨量的銷售額和 365 初始出貨量的混合，這意味著我們要到 2025 年第一季才能看到 365 在美國收入的全部影響。

We continue to serve the European market with Eversense E3 and expect in the first quarter to submit 365 for its CE mark in Europe. While we will not be providing 2025 revenue guidance until our next earnings call, I can tell you that we are ecstatic with the early response to 365 that we've received from patients and physicians thus far. And we are looking forward to an exciting and successful year ahead.

我們將繼續透過 Eversense E3 服務歐洲市場，並預計在第一季提交 365 在歐洲的 CE 標誌。雖然我們要等到下次收益電話會議才能提供 2025 年的收入指引，但我可以告訴大家，我們對迄今為止患者和醫生對 365 的早期反應感到非常高興。我們期待著即將到來的激動人心、成功的一年。

With that, I'll now turn it over to our CFO, Rick Sullivan, who will provide more details on our financial results, recent financing activities and our restructuring efforts. Rick?

現在，我將把時間交給我們的財務長 Rick Sullivan，他將提供有關我們的財務表現、最近的融資活動和重組工作的更多詳細資訊。瑞克？

Thank you, Tim, and good afternoon, everyone. We appreciate the opportunity today to update you on our business. In the third quarter of 2024, net revenue was $4.3 million compared to $6.1 million in the prior year period due to the inventory dynamics associated with the 365-day product launch, where we've sought to reduce U.S. E3 inventories in anticipation of the transition to the 365-day product. U.S. revenues for the third quarter was $2.4 million, and revenue outside the U.S. was $1.9 million.

謝謝你，提姆，大家下午好。我們很高興今天有機會向您介紹我們的業務。2024 年第三季度，淨收入為 430 萬美元，而去年同期為 610 萬美元，這是由於與 365 天產品發布相關的庫存動態造成的，我們試圖減少美國 E3 庫存，以期過渡到 365 天產品。第三季美國營收為 240 萬美元，美國以外營收為 190 萬美元。

As a reminder, our collaboration agreement with Ascensia is for revenue sharing with the percentage of revenue to Ascensia increasing based on duration of the contract and annual revenue levels. We recognize our portion of revenue when shipments are delivered to Ascensia, and they take title and ownership of the inventory. This begins the multistep distribution to patients via Ascensia and their distributors. We manage our manufacturing based on patient demand generated from commercial activities, targeting 60 to 90 days of inventory across the various channels.

提醒一下，我們與 Ascensia 的合作協議是收入分成，Ascensia 的收入百分比會根據合約期限和年度收入水平而增加。當貨物交付給 Ascensia 時，我們確認我們的收入份額，並且他們取得庫存的所有權和所有權。這開始了透過 Ascensia 及其分銷商向患者進行多步驟分發的過程。我們根據商業活動產生的患者需求來管理我們的生產，目標是在各個管道實現 60 至 90 天的庫存。

Therefore, our shipments to Ascensia during the quarter are largely intended to support future demand for Eversense. Third quarter shipments were intended to support the file demand for the U.S. 180-day systems. We began the planned transition to the 365-day product launch in the fourth quarter. We do not expect to reach target inventory levels for 365-day product in the fourth quarter and will gradually increase inventory to target levels through the first half of 2025.

因此，我們本季向 Ascensia 的出貨主要是為了支持 Eversense 未來的需求。第三季的出貨量旨在滿足美國 180 天系統的文件需求。我們從第四季開始按計劃過渡到 365 天產品發布。我們預計第四季不會達到 365 天產品的目標庫存水平，並將在 2025 年上半年逐步將庫存增加到目標水準。

Gross loss in Q3 2024 was $4.1 million, a decrease from a gross profit of $1.2 million in the prior year period. This decline was primarily driven by onetime charges associated with the transition of Eversense E3 to Eversense 365.

2024 年第三季毛虧損為 410 萬美元，較去年同期的 120 萬美元毛利下降。這種下降主要是由於 Eversense E3 向 Eversense 365 過渡期間產生的一次性費用所致。

Research and development expenses in Q3 2024 were $10.5 million, a decrease of $2.3 million compared to $12.8 million in the prior year period. The decrease was primarily due to the completion of the ENHANCE clinical trial, which drove a $2.6 million reduction in clinical study costs over the prior year period.

2024 年第三季研發費用為 1,050 萬美元，與去年同期的 1,280 萬美元相比減少 230 萬美元。下降的主要原因是 ENHANCE 臨床試驗的完成，該試驗使臨床研究成本比去年同期減少了 260 萬美元。

Third quarter 2024 selling, general and administrative expenses were $8.3 million, an increase of $0.9 million compared to $7.4 million in the prior year period, primarily driven by increased personnel and consulting costs related to Eon Care and other commercial efforts to support Ascensia.

2024 年第三季銷售、一般和行政費用為 830 萬美元，較去年同期的 740 萬美元增加 90 萬美元，主要原因是與 Eon Care 相關的人員和諮詢成本增加以及支持 Ascensia 的其他商業努力。

For the 9 months ended September 2024, operating loss was $22.8 million compared to $19 million in the third quarter of 2023 due to inventory write-offs associated with the transition to the 365-day product, offset by a reduction in clinical trial costs. For the 3 months ended September 2024, total net loss was $24 million or a $0.04 loss per share compared to a net loss of $24.1 million or a $0.04 loss per share in the third quarter of 2023. Net income increased by $0.1 million due to the reduction in R&D expenses.

截至 2024 年 9 月的 9 個月，營業虧損為 2,280 萬美元，而 2023 年第三季為 1,900 萬美元，原因是向 365 天產品過渡相關的庫存註銷，但臨床試驗成本的減少抵消了這一損失。截至 2024 年 9 月的 3 個月，總淨虧損為 2,400 萬美元，即每股虧損 0.04 美元，而 2023 年第三季的淨虧損為 2,410 萬美元，即每股虧損 0.04 美元。由於研發費用減少，淨收入增加了 10 萬美元。

As of September 30, 2024, cash, restricted cash, cash equivalents and short-term investments totaled $74.8 million, and debt and accrued interest was $55.9 million. In Q3 and in early Q4, we raised gross proceeds of more than $20 million, including the $16 million offering announced in October. These financings improve our current balance sheet and provide us the flexibility to repay the 2025 notes due early next year, significantly reducing our outstanding debt. In October, we also executed a restructuring that included a reduction in force of nearly 20% and a planned reduction in operating expenses with a target of reducing cash operating expenses by more than $10 million in 2025.

截至 2024 年 9 月 30 日，現金、受限現金、現金等價物及短期投資總額為 7,480 萬美元，債務及應計利息為 5,590 萬美元。在第三季和第四季初，我們籌集了超過 2,000 萬美元的總收益，其中包括 10 月宣布的 1,600 萬美元發行。這些融資改善了我們目前的資產負債表，並為我們提供了償還明年初到期的 2025 年票據的靈活性，從而大大減少了我們的未償債務。10 月份，我們還實施了重組，包括裁員近 20% 併計劃削減營運費用，目標是到 2025 年將現金營運費用減少 1,000 多萬美元。

These efforts combined extend our cash runway for over a year into late 2025. We also recently acquired the Eversense insertion network assets of the nurse practitioner group and have begun the transition to our Eon Care subsidiaries. As we work to grow this network, we believe the opportunity of the CPT code payments associated with the insertions will enable a self-sustaining economic model for this initiative. We anticipate that having further influence over the insertion process through this strategic move will drive efficiencies, increase insertion throughput and ensure continued focus for an excellent patient experience. The acquisition will have a minimal cash impact to our Q4 financials.

這些努力加起來將使我們的現金流延長一年多，直到 2025 年底。我們最近也收購了執業護理師集團的 Eversense 插入網路資產，並已開始向 Eon Care 子公司過渡。在我們努力擴大這個網絡的過程中，我們相信與插入相關的 CPT 代碼支付機會將為該計劃提供一個自我維持的經濟模式。我們預計，透過這項策略措施對插入過程產生進一步的影響將提高效率，增加插入吞吐量並確保持續專注於卓越的患者體驗。此次收購對我們第四季的財務狀況的現金影響微乎其微。

Turning to our outlook for the remainder of 2024. Senseonics expects full year 2024 global net revenue to be approximately $22 million as we begin to transition our U.S. products to Eversense 365 following its approval in late Q3. The full year 2024 financial outlook assumes more than doubling the U.S. new patient starts and increasing the global installed base by approximately 50% in 2024 compared to 2023.

展望 2024 年剩餘時間的前景。Senseonics 預計 2024 年全年全球淨收入約為 2,200 萬美元，因為我們在第三季末獲得批准後開始將我們的美國產品過渡到 Eversense 365。2024 年全年財務展望預計，與 2023 年相比，2024 年美國新增病患數量將增加一倍以上，全球安裝基數將增加約 50%。

Inventory dynamics associated with the 365-day product launch impacted product sales in the third quarter as we began reducing E3 inventory in anticipation of the transition to Eversense 365. Sales are expected to accelerate in the fourth quarter based on anticipated initial 365-day product demand and the initial ramp of the Mercy collaboration.

由於我們開始減少 E3 庫存以期過渡到 Eversense 365，因此與 365 天產品發布相關的庫存動態影響了第三季的產品銷售。根據預期的初始 365 天產品需求和 Mercy 合作的初始成長，第四季銷售額預計將會加速成長。

While we're not yet providing guidance for 2025, we're confident that based on early lead generation, Eversense 365 revenue growth should accelerate further in 2025 when it will be the only product sold in the U.S. We also continue to expect gross margins for 2024 to be in the range of 10% to 15%, excluding the $4.8 million of onetime charges associated with the transition to the 365-day product. We're really excited about the unit economics of Eversense 365 and expect our gross profit margins to meaningfully improve almost immediately, approaching 30% next year. We expect our operating expenses for 2024 to continue to be in the range from $77.5 million to $82.5 million.

雖然我們尚未提供 2025 年的指引，但我們相信，基於早期的潛在客戶開發，Eversense 365 的收入成長應在 2025 年進一步加速，屆時它將成為美國唯一銷售的產品。我們也繼續預期 2024 年的毛利率將在 10% 至 15% 之間，不包括與向 365 天產品過渡相關的 480 萬美元的一次性費用。我們對 Eversense 365 的單位經濟效益感到非常興奮，並預計我們的毛利率將立即顯著提高，明年將接近 30%。我們預計 2024 年的營運費用將持續維持在 7,750 萬美元至 8,250 萬美元之間。

For 2025, we expect to see cash operating expenses decrease by $10 million compared to 2024 as a result of the recent restructuring efforts. With Eversense 365 on the market and the expected positive margin contribution, we'll work to ensure that the organization is rightsized and staying disciplined in our use of capital while remaining positioned to support both our commercial partner in driving adoption of Eversense and our important work progressing our product pipeline. With that, I'll turn it back to Tim.

由於最近的重組努力，我們預計 2025 年的現金營運支出將比 2024 年減少 1,000 萬美元。隨著 Eversense 365 上市並預期產生正利潤貢獻，我們將努力確保組織規模合適並在資本使用方面保持紀律，同時繼續支持我們的商業合作夥伴推動 Eversense 的採用以及我們推進產品線的重要工作。說完這些，我就把話題轉回給提姆。

Thanks Rick. And as I mentioned at the start of the call, we feel confident in sic's future trajectory. We are well positioned as we head into the final quarter of the year with a solid foundation of new approvals launch momentum and a strengthened balance sheet. We see the opportunity to drive growth through the delivery of our strategic initiatives. We're executing our development and operational initiatives. While Ascensia continues to enhance its commercial capabilities.

謝謝里克。正如我在電話會議開始時提到的那樣，我們對 sic 的未來發展充滿信心。進入今年最後一個季度，我們已做好充分準備，擁有堅實的基礎，新審批啟動勢頭強勁，資產負債表也得到加強。我們看到了透過實施策略性舉措來推動成長的機會。我們正在執行我們的開發和營運計劃。同時Ascensia不斷增強其商業能力。

Further, we are building from the strong foundation of our differentiated technology and a pipeline that has continuously advanced next generation products, the successful clearance and now the launch of our 365 day product represents one of the most significant catalysts in the company's history. And we are looking for 2025 to be a transformational year for the company. There is a large opportunity in front of us as we work to continue to simplify the lives of more people with diabetes and build higher growth and shareholder value.

此外，我們以差異化技術和不斷推進下一代產品的管道為基礎，成功清關以及現在推出的 365 天產品是該公司歷史上最重要的催化劑之一。我們期待 2025 年成為公司的轉型之年。當我們努力繼續簡化更多醣尿病患者的生活並實現更高的成長和股東價值時，我們面前面臨著巨大的機會。

In addition to Rick Brian and myself joining us for questions. Today is Mule Jane, our Chief Operating Officer.

除了 Rick Brian 和我之外，我們還將參與回答問題。今天是我們的營運長 Mule Jane。

Thank you for all your time today operator. Let's now open up the call for questions.

感謝您今天抽出時間。現在讓我們開始提問。

(Operator Instructions)

（操作員指示）

Brian Langan, Morgan Stanley.

摩根士丹利的 Brian Langan。

My question is, do you have an idea what the potential market is in the United States and also in in Europe?

我的問題是，您是否知道美國和歐洲的潛在市場是什麼？

Thanks, Brian. Sure. Obviously, the market for CGM is huge and growing. We had something like $11 billion, $12 billion this year. We calculate the CAGR to be in the 20%, 22% range.

謝謝，布萊恩。當然。顯然，CGM 市場巨大且不斷成長。今年我們的收入大約是 110 億美元到 120 億美元。我們計算出複合年增長率在 20% 至 22% 之間。

Eversense can absolutely be a participant in the majority of that market. We are -- as you may be aware, we are seeing most of our patients are coming from type 2s with the indication for insulin -- basal insulin. And that segment of the market is even significantly underpenetrated. So that's even a larger opportunity for us. So we see it as an alternative for the folks that are on CGM today and that we'll participate meaningfully as the product generations roll out here.

Eversense 絕對可以成為該市場大部分份額的參與者。您可能知道，我們發現大多數患者都是第 2 型糖尿病患者，需要注射胰島素——基礎胰島素。而這細分市場的滲透率甚至還遠遠不夠。所以這對我們來說是一個更大的機會。因此，我們將其視為當今使用 CGM 的人們的替代方案，隨著產品世代的推出，我們將積極參與其中。

Okay. All right. Thank you.

好的。好的。謝謝。

Vernon Bernardino, H.C. Wainright.

貝納迪諾、H.C. 溫賴特。

Hi, good afternoon, everyone. Thanks for taking my question. Question I have is, I think it was you, Rick, who mentioned your gross margin would improve to -- if you could just remind us what you had said your gross margin would get to in 2025 and how that might change after 2025.

大家好，下午好。感謝您回答我的問題。我的問題是，里克，我想是你提到你的毛利率會提高到——如果你能提醒我們一下你說過你的毛利率在 2025 年會達到多少，以及 2025 年後會發生怎樣的變化。

Hey, Vernon, great to hear from you. Thanks for the question. So in 2025, with the improved unit economics of the 365-day product, we expect that the gross profit margins will increase, approaching 30% by year-end and then continue to increase thereafter. With the partnership as we have it today, we think that the gross profit margins could get to 50%, and that's after the revenue sharing with the Ascensia partnership.

嘿，弗農，很高興收到你的來信。謝謝你的提問。因此，到 2025 年，隨著 365 天產品單位經濟效益的提高，我們預計毛利率將會上升，到年底將接近 30%，然後繼續上升。我們認為，憑藉目前的合作關係，毛利率可以達到 50%，這還是在與 Ascensia 合作夥伴分享收入之後。

And regarding the switches to 365, do you anticipate that a majority of those will occur quickly? Or do you think that will be kind of slow so that we can look at how patients who went on 180, the 6-month Eversense, as a rate of switch going into 2025?

關於向 365 的轉換，您是否預計其中大部分會很快發生？或者您認為這個速度會比較慢，以便我們可以觀察使用 180 個 6 個月 Eversense 的患者在 2025 年的轉換率如何？

Yes, Vernon. So we are transitioning the market very quickly. In the U.S., it's pretty much a light switch, right? We're -- if you're up next for a sensor, you're going to go to the 365. Europe, of course, is going to take a little bit longer because we are seeking the approval to commercialize over there.

是的，佛農。所以我們正在非常快速地轉變市場。在美國，它基本上就是一個電燈開關，對嗎？我們 — — 如果您接下來要使用感測器，那麼您將使用 365。當然，歐洲還需要更長的時間，因為我們正在尋求那裡的商業化批准。

But it's essentially immediate for, obviously, all new patients. But anybody that's coming off of 180, their next sensor will be 365.

但顯然，對於所有新患者來說，這基本上是立即的。但對於任何超過 180 的人來說，他們的下一個感測器將是 365。

Okay. Thank you. That's very helpful. Thanks for taking my question and congrats on the results looking forward to meeting this third quarter, I mean the fourth quarter.

好的。謝謝。這非常有幫助。感謝您回答我的問題，並祝賀您所取得的成果，期待第三季度，也就是第四季的業績。

Thank you. This does conclude our question-and-answer session. I'd be happy to return the call to Tim Goodnow for closing comments.

謝謝。我們的問答環節到此結束。我很樂意回電給 Tim Goodnow 徵求他的最後評論。

Great. Well, thank you for the opportunity to speak. We appreciate it and we look forward to updating you on our next quarterly call in Q1. Thank you.

偉大的。好吧，感謝您給我這次發言的機會。我們對此表示感謝，並期待在第一季的下一次季度電話會議上向您通報最新情況。謝謝。

This does conclude the Senseonics third quarter, 2024 earnings call. You may now disconnect your lines and everyone have a great day.

這確實結束了 Senseonics 2024 年第三季財報電話會議。現在您可以斷開線路，祝大家有個愉快的一天。