Senseonics Holdings Inc (SENS) 2024 Q4 法說會逐字稿

Good day, everyone, and welcome to today's Senseonics fourth quarter in full year 2024 earnings call. (Operator Instructions) Please note today's call will be recorded. It is now my pleasure to turn the conference over to Jeremy Feffer from LifeSci Advisors. Please go ahead.

大家好，歡迎參加今天的 Senseonics 2024 年全年第四季財報電話會議。（操作員指示）請注意，今天的通話將會被錄音。現在我很高興將會議交給 LifeSci Advisors 的 Jeremy Feffer。請繼續。

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.

謝謝。我是 LifeSci Advisors 的 Jeremy Pfeffer。在我們今天開始之前，請允許我提醒您，該公司的評論包括前瞻性陳述。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。

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 10-K for the year ended December 31, 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.

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這些前瞻性陳述所表達或暗示的結果有重大差異的因素清單已在風險因素下以及我們截至 2024 年 12 月 31 日的 10-K 表年度報告和我們向美國證券交易委員會提交的其他報告中進行了詳細說明。這些文件可在我們網站 www.senseonics.com 的投資者關係部分找到。

We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law.

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

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。說到這裡，我想把電話轉給總裁兼執行長 Tim Goodnow。提姆？

Thanks, Jeremy, and thank you to everyone on the call today for taking the time to join us. As Jeremy mentioned, we'll have Brian with us again today who can provide a boots-on-the-ground perspective on how Eversense 365 has been received in the marketplace since its launch in November.

謝謝，傑里米，也感謝今天參加電話會議的每個人抽出時間來參加我們的會議。正如 Jeremy 所提到的，今天我們將再次邀請 Brian 與我們一起，他可以從實際角度介紹 Eversense 365 自 11 月推出以來在市場上的反響。

Before we hear from Brian, I'll provide a look back on 2024 and the strong progress that we've made. I'll provide an update on our recent CE Mark submission, our European launch planning, our pipeline programs Gemini and Freedom, and I'll touch on our current partnerships with Mercy and SweetSpot as well as our ongoing progress with insulin pump manufacturers. Finally, Rick will run you through the numbers and then we'll take your questions.

在聽取 Brian 的發言之前，我將回顧 2024 年以及我們取得的重大進展。我將提供有關我們最近提交的 CE 標誌、我們的歐洲發布計劃、我們的管道計劃 Gemini 和 Freedom 的最新信息，並且我將談及我們目前與 Mercy 和 SweetSpot 的合作夥伴關係以及我們與胰島素泵製造商的持續進展。最後，里克將向您介紹這些數字，然後我們將回答您的問題。

On September 17, 2024, marked the US approval of Eversense 365, the world's first and only once yearly continuous glucose monitor. The company was founded on the premise of a one year sensor and we have been working for many years to reach this goal increasing from a 90-day sensor to a 180-sensor and finally to Eversense 365. As a reminder, the Eversense 365 sensor is the backbone of both the Gemini and Freedom system which I'll elaborate on in a few minutes.

2024 年 9 月 17 日，美國批准了世界上第一台也是唯一一台每年一次的連續血糖監測儀 Eversense 365。該公司以一年感測器為前提成立，多年來我們一直致力於實現這一目標，從 90 天感測器增加到 180 天感測器，最後增加到 Eversense 365。提醒一下，Eversense 365 感測器是 Gemini 和 Freedom 系統的支柱，我將在幾分鐘內詳細說明。

Since the launch, we've been very pleased with the positive reception and feedback we've received from both providers and patients. We have more patients than ever switching to Eversense 365, more doctors prescribing Eversense, and more health systems interested in partnering with us than we've ever had before. Brian will tell you more about our performance metrics but I'm extremely pleased with our early performance on the 365 launch and with what has been accomplished over the past couple of months.

自推出以來，我們對來自供應商和患者的正面回饋感到非常高興。與我們相比，現在有越來越多的患者轉用 Eversense 365，越來越多的醫生開出 Eversense 處方，並且有越來越多的醫療系統有興趣與我們合作。Brian 將向您詳細介紹我們的績效指標，但我對我們在 365 發佈時的早期表現以及過去幾個月所取得的成就感到非常滿意。

As you may have seen, we have now filed our CE mark for approval for Eversense 365 and pending clearance we are planning for a launch in the European Union later this year.

正如您可能已經看到的，我們現在已經為 Eversense 365 提交了 CE 標誌審批，等待審批通過後，我們計劃於今年稍後在歐盟推出。

Ascensia has sales and distribution channels in place in Europe to support our launch and we look forward to the opportunity to increase the number of patients benefiting from Eversense by bringing the value proposition of our one year one sensor to patients in the European market that we serve. We expect to launch Eversense 365 in the second half of 2025.

Ascensia 在歐洲擁有銷售和分銷管道來支持我們的產品發布，我們期待有機會透過將我們的一年一個感測器的價值主張帶給我們所服務的歐洲市場的患者來增加從 Eversense 中受益的患者數量。我們預計將於 2025 年下半年推出 Eversense 365。

I also want to highlight the important work we continue to do to advance our product pipeline. Our development teams are working continuously to improve the patient's experience with Eversense. Our feasibility study for Gemini -- the one year sensor with the battery which allows for both continuous as well as optional swipe testing -- it's expected to be complete this year and we are on target to submit our IDE for a pivotal study by year end.

我還想強調我們為推進產品線而持續進行的重要工作。我們的開發團隊正在不斷努力改善患者使用 Eversense 的體驗。我們對 Gemini 的可行性研究——配備電池的一年感測器，可進行連續測試和可選滑動測試——預計將於今年完成，我們計劃在年底前提交 IDE 進行關鍵研究。

We are also making progress on our Freedom system which incorporates bluetooth within the sensor thereby eliminating the need for an on-body transmitter by allowing the sensor to communicate directly with the phone.

我們的 Freedom 系統也正在取得進展，該系統在感測器中加入了藍牙功能，透過允許感測器直接與手機通信，不再需要體內發射器。

The backbone for both of these systems is the updated chemistry and technology already approved in the Eversense 365. We believe these advances will create a strong platform on which to add the battery, bluetooth technology, and other features that will continue to improve the patient experience.

這兩個系統的核心是 Eversense 365 中已經批准的更新的化學和技術。我們相信這些進步將創造一個強大的平台，可以在其上添加電池、藍牙技術和其他功能，從而繼續改善患者體驗。

With our integrated continuous glucose monitor designation received last year we are also working actively towards pump integration. This will allow Eversense 365 to communicate wirelessly to pumps to augment and control insulin delivery.

憑藉去年獲得的整合式連續血糖監測儀稱號，我們也積極致力於泵浦整合。這將允許 Eversense 365 與幫浦進行無線通信，以增強和控制胰島素輸送。

Currently, this is only possible with short term CGMs requiring entirely new sensors, disposable insertion hardware, and bulky packaging, and a repetitive insertion process with every two-week sensor replacement. We expect to provide you with additional updates in the coming quarters on our ongoing discussion with insulin pump manufacturers.

目前，這僅適用於短期 CGM，需要全新的感測器、一次性插入硬體和笨重的包裝，以及每兩週更換一次感測器時重複的插入過程。我們期望在未來幾季為您提供有關我們與胰島素幫浦製造商正在進行的討論的更多更新資訊。

In addition, we continue to focus our efforts on expanding relationships with additional health systems and accountable care organizations. Our partnership with Mercy Health provides access to 365 for its patients' populations that could benefit from wearing a CGM.

此外，我們將繼續致力於擴大與其他醫療系統和負責任的醫療組織的關係。我們與 Mercy Health 合作，為其患者群體提供 365 天的護理服務，使他們能夠從佩戴 CGM 中受益。

Based on this cost containing strategic arrangement, several other health systems have been in contact with us to inquire about Eversense use and to discuss whether they could implement a similar program. Stay tuned for additional details on these types of partnerships and our initiatives to create greater access to Eversense.

基於此控製成本的策略安排，其他幾個醫療系統已與我們聯繫，詢問 Eversense 的使用情況，並討論是否可以實施類似的計劃。請繼續關注這些類型的合作夥伴關係的更多詳細資訊以及我們為擴大 Eversense 存取權限所採取的措施。

Lastly, we continue to explore collaborations similar to our recently announced integration with SweetSpot where Eversense 365 populates glucose readings directly into SweetSpot's tech-enabled diabetes service that includes clinical support for patients and accessibility for endocrinologists.

最後，我們繼續探索類似於我們最近宣布的與 SweetSpot 整合的合作，其中 Eversense 365 將血糖讀數直接填充到 SweetSpot 的技術支援型糖尿病服務中，其中包括對患者的臨床支持和對內分泌學家的可訪問性。

From our own development efforts to our collaborations with commercial and development partners we continue advancing our technology offering and access to make managing diabetes more convenient for the patients we serve.

從我們自己的開發努力到與商業和開發夥伴的合作，我們不斷改進我們的技術產品和途徑，使我們服務的患者能夠更方便地管理糖尿病。

Now I'd like to transition the call to Brian, Ascensia's President of CGM for an overview of our 365 launch progress. Brian, the mic is yours.

現在，我想將電話轉給 Ascensia 的 CGM 總裁 Brian，請他概述我們的 365 發布進度。布萊恩，麥克風是你的。

Thanks, Tim. I'm excited to be here with you today and share some of the metrics that we've been tracking during the US launch. As a reminder, there are four pillars to our commercial strategy for Eversense 365: direct consumer marketing to drive awareness; marketing to healthcare professionals to build a network of physicians and nurse practitioners to prescribe and insert the sensor; collaboration and targeted account efforts with hospital systems provide system-wide access to Eversense 365; and as we build our install base, it is equally important that we retain and renew our existing users.

謝謝，蒂姆。我很高興今天能和大家在一起，分享我們在美國發布期間追蹤的一些指標。提醒一下，Eversense 365 的商業策略有四大支柱：直接消費者行銷以提高知名度；向醫療保健專業人士行銷以建立醫生和執業護理師網絡來開處方和插入感測器；與醫院系統的合作和有針對性的帳戶努力提供對 Eversense 365 的全系統存取；在我們建立現有用戶基礎的同時，保留和安裝用戶也同樣重要。

Four months in I'm pleased with the interest both users and prescribers have shown in the Eversense 365 product and its advantages over short-term CGMs. Feedback has been positive as to the sensors continued superior performance, increased wear time of one year, and the reduced calibrations to once a week -- a true game changer for the patient. We are also seeing increased access to new accounts with the introduction of the 365-day sensor.

四個月後，我很高興看到使用者和處方者對 Eversense 365 產品表現出的興趣以及它相對於短期 CGM 的優勢。關於感測器繼續保持卓越性能、佩戴時間延長一年以及校準次數減少至每週一次等方面的反饋都是積極的——這對患者來說是一個真正的改變。隨著 365 天感測器的引入，我們還看到新帳戶的訪問量增加。

In 2024, we saw the majority of our prescriptions coming from first-time prescribers and this bodes well for future growth. While early interest and uptake metrics have been favorable we recognize that we are early in the launch. So we have to remain focused on driving increased awareness and adoption of ever since in order to realize its promise.

2024 年，我們發現大部分處方來自首次開處方的醫生，這預示著未來的成長前景良好。雖然早期的興趣和吸收指標一直很好，但我們認識到我們處於發布的早期階段。因此，我們必須繼續致力於提高人們對它的認識和採用，以實現它的承諾。

We continue to work directly with payers to transition our 180-day reimbursement over to the full year sensor. This is particularly important for the Medicare segment so that reimbursement is clear and straightforward for our providers.

我們將繼續與付款人直接合作，將 180 天的報銷過渡到全年的報銷。這對於醫療保險部門來說尤其重要，這樣我們的提供者就可以清晰、直接地獲得報銷。

With that in mind, Ascensia and Senseonics are focused on awareness campaigns through direct consumer and sales force efforts working to grow sales to support updated reimbursement specifically to the 365 day product.

考慮到這一點，Ascensia 和 Senseonics 專注於透過直接消費者和銷售人員的努力進行宣傳活動，努力提高銷售額，以支持針對 365 天產品的更新報銷。

We are driving strong sales execution, continued refinement of our marketing message and campaigns which to date have been very well received, and we're finding our customer service efforts to simplify the customer journey for the patients and the physicians we serve.

我們正在推動強勁的銷售執行，不斷完善我們的行銷訊息和活動，迄今為止這些資訊和活動都受到了熱烈歡迎，我們發現我們的客戶服務工作可以簡化我們服務的患者和醫生的客戶旅程。

Up to this point, most of the progress we've been reporting has been qualitative but today let me share some more tangible quantitative key performance indicators with you.

到目前為止，我們報告的大部分進展都是定性的，但今天讓我與大家分享一些更具體的量化關鍵績效指標。

In 2024, our patient base increased 56% to approximately 6,000 global patients; our target growth was 50%. We also exceeded 2,400 annual US Eversense prescribers during the year a 73% increase over the prior year and we saw direct consumer leads increase by 40% compared to 2023 with average monthly leads more than doubling following the launch of 365 in Q4.

2024 年，我們的患者群體將增加 56%，達到全球約 6,000 名患者；我們的目標成長率為 50%。今年，我們的美國 Eversense 年度處方量也超過了 2,400 名，比前一年增加了 73%，我們看到直接消費者線索與 2023 年相比增加了 40%，自第四季度推出 365 以來，平均每月線索量增加了一倍以上。

We reached new patient shipments of over 3,000 for 2024 and saw an impressive number of patients switched to ever since from competitive CGMs. Approximately 81% of our patient base have switched from other CGMs.

2024 年，我們的新患者出貨量超過 3,000 名，並且從那時起，有大量患者從競爭對手的 CGM 轉而使用我們的 CGM。我們大約 81% 的患者已從其他 CGM 轉換過來。

We also continue to see strong growth in the Type 2 segment. 69% of our new users during the year were people with Type 2 diabetes. This launch is going well and it's clear that we are making a positive impact for patients and healthcare providers.

我們也看到第 2 型糖尿病領域持續保持強勁成長。今年我們新增的用戶中有 69% 是第 2 型糖尿病患者。此次發布進展順利，很明顯我們正在為患者和醫療保健提供者帶來正面的影響。

Lastly, we are excited to begin planning activities for the upcoming 365 launch in Europe. We will be previewing the 365-day sensor in a few weeks at ATTD in Amsterdam. Positive feedback has definitely spread to our European users, healthcare providers, and our commercial teams. They will also benefit from the learnings we gleaned from the launch here in the United States.

最後，我們很高興開始為即將在歐洲推出的 365 進行規劃活動。我們將在幾週後於阿姆斯特丹舉行的 ATTD 上預覽 365 天感測器。正面的回饋肯定已經傳播給了我們的歐洲用戶、醫療保健提供者和我們的商業團隊。他們也將受益於我們在美國發表會上所獲得的經驗。

Thank you for your time and with that, I will turn it over to Rick to review our financial performance.

感謝您抽出時間，現在我將把時間交給 Rick 來審查我們的財務表現。

Thank you, Brian, and good afternoon, everyone. We appreciate the opportunity today to update you on our financials and provide top line revenue guidance for 2025.

謝謝你，布萊恩，大家下午好。我們很高興今天有機會向您通報我們的財務狀況並提供 2025 年的收入指引。

In the fourth quarter of 2024, net revenue was $8.3 million compared to $8 million in the prior year period. US revenue for the fourth quarter was $6.2 million and revenue outside the US was $2.1 million.

2024 年第四季淨收入為 830 萬美元，而去年同期為 800 萬美元。第四季美國營收為 620 萬美元，美國以外營收為 210 萬美元。

As always, a quick reminder regarding our revenue recognition. 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.

像往常一樣，快速提醒一下我們的收入確認。我們與 Ascensia 的合作協議是收入分成，Ascensia 的收入百分比根據合約期限和年度收入水平而增加。

For most sales we recognize our portion of revenue when shipments are delivered to Ascensia. This begins the multi-step 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.

對於大多數銷售，我們在貨物送達 Ascensia 時確認我們的收入份額。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. Following the launch of Eversense 365, we are still increasing inventory to reach 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。在推出 Eversense 365 之後，我們仍在增加庫存，以達到 2025 年上半年的目標水準。

We also sell product through an office consignment program. In 2024, we saw this consignment program continue to grow and now approximately 15% of our revenue flows through this channel. We have well over 100 healthcare providers participating in the consignment program which enables a physician to have the product on the shelf and ready for patients.

我們也透過辦公室寄售計畫銷售產品。2024 年，我們看到這個寄售計畫持續成長，現在我們大約 15% 的收入來自這個管道。我們有超過 100 家醫療保健提供者參與寄售計劃，這使醫生能夠將產品放在貨架上並隨時為患者提供。

This program increases the convenience to healthcare providers and patients facilitating faster and even same-day insertions. In the consignment program, we recognize revenue at the time of the procedure. We also record a sales commission expense for Ascensia support with sales and marketing efforts on revenue through this channel.

該計劃為醫療保健提供者和患者提供了更多便利，使其能夠更快地甚至在當天完成插入。在寄售計畫中，我們在辦理手續時確認收入。我們也記錄了 Ascensia 透過此管道對銷售和行銷工作的支援的銷售佣金費用。

In Q4 2024, gross profit was $4 million an increase from a gross profit of $1.1 million in the prior year period. This increase in gross profit was primarily driven by increased margins on the 365 day product but also includes the positive impact of approximately $1.6 million in manufacturing costs, previously expense to research and development expenses prior to FDA approval of the 365-day product.

2024 年第四季，毛利為 400 萬美元，較去年同期的 110 萬美元成長。毛利的成長主要得益於 365 天產品利潤率的提高，但也包括約 160 萬美元製造成本的正面影響，這筆成本此前在 FDA 批准 365 天產品之前被計入研發費用。

When we include these costs in our gross profit margin calculation, we would still see margins north of 25%. This is very encouraging considering that we still have limited manufacturing scale with it being so early in the product life cycle that we only had US 365-day product sales for part of the quarter and that European sales continue to be the lower margin 180-day product.

當我們將這些成本納入毛利率計算時，我們仍然會看到利潤率超過 25%。這是非常令人鼓舞的，因為我們的生產規模仍然有限，而且產品生命週期還處於早期階段，我們在本季度的部分時間裡只有美國 365 天的產品銷售，而歐洲的銷售仍然是利潤率較低的 180 天產品。

Research and development expenses in Q4 2024 were $9.4 million a decrease of $1.4 million compared to the prior year period. The decrease was primarily due to a reduction in clinical study spend and consultant costs due to the completion of the 365-day product trials.

2024 年第四季研發費用為 940 萬美元，較去年同期減少 140 萬美元。下降的主要原因是 365 天產品試驗完成後臨床研究支出和顧問費用減少。

Fourth quarter of 2024, selling, general, and administrative expenses were $8.9 million an increase of $1.5 million compared to $7.4 million in the prior year period primarily driven by personnel costs, consulting fees, sales commissions, and legal expenses.

2024 年第四季度，銷售、一般和行政費用為 890 萬美元，較去年同期的 740 萬美元增加 150 萬美元，主要原因是人員成本、諮詢費、銷售佣金和法律費用。

Net loss was $15.5 million or a $0.02 loss per share in the fourth quarter of 2024 compared to net loss of $17.2 million or a $0.03 loss per share in the fourth quarter of 2023. Net loss decreased by $1.7 million, primarily due to improved gross profit margins of Eversense 365.

2024 年第四季淨虧損為 1,550 萬美元，即每股虧損 0.02 美元，而 2023 年第四季淨虧損為 1,720 萬美元，即每股虧損 0.03 美元。淨虧損減少 170 萬美元，主要由於 Eversense 365 的毛利率提高。

For the full year, total revenue was $22.5 million compared to $22.4 million in 2023. US revenue is $15.3 million in 2024 compared to $14.1 million in the prior year. And revenue outside the US was $7.2 million in 2024 compared to $8.3 million in 2023.

全年總收入為 2,250 萬美元，而 2023 年為 2,240 萬美元。2024 年美國收入為 1,530 萬美元，而前一年為 1,410 萬美元。2024 年美國以外地區的收入為 720 萬美元，而 2023 年為 830 萬美元。

Although total revenue was consistent from 2023 to 2024, we did see patient growth increase by more than 50%. This difference in patients compared with revenue resulted primarily from the revenue recognition treatment previously explained and inventory stocking at the end of 2023 that was utilized for new patients in 2024.

儘管 2023 年至 2024 年的總收入保持不變，但我們確實看到患者成長率超過了 50%。患者數量與收入數量的差異主要源於先前解釋的收入確認處理以及 2023 年底用於 2024 年新患者的庫存。

Gross profit for 2024 was $0.5 million a decrease from $3.1 million in 2023. The decrease in gross profit was primarily driven by $4.8 million in one-time charges as a result of the transition from Eversense E3 to Eversense 365 partially offset by an estimated reduction of $1.6 million in pre-approval of manufacturing costs previously expense to research and development. Excluding these one-time product transition costs, gross profit margin for full year 2024 would be more than 16%.

2024 年毛利為 50 萬美元，較 2023 年的 310 萬美元減少。毛利的下降主要是由於從 Eversense E3 過渡到 Eversense 365 而產生的 480 萬美元的一次性費用，但先前用於研發的製造成本預批准預計減少 160 萬美元，部分抵消了這一影響。除去這些一次性產品轉型成本，2024 年全年毛利率將超過 16%。

Selling general and administrative expenses for 2024 increased by $4.3 million year over year to $34.2 million. The increase was primarily driven by personnel costs, consulting fees, sales commissions, and legal expenses.

2024 年銷售一般及行政費用年增 430 萬美元，達到 3,420 萬美元。成長的主要原因是人事成本、諮詢費、銷售佣金和法律費用。

Research and development expenses for 2024 decreased by $7.6 million from 2023 to $41.1 million. The decrease was primarily due to a reduction in clinical study spend and other research costs due to the completion of 365-day product trials. These savings were partially offset by pre-approval inventory costs associated with the manufacturing of the 365-day product.

2024 年研發費用較 2023 年減少 760 萬美元至 4,110 萬美元。下降的主要原因是365天產品試驗的完成導致臨床研究支出和其他研究成本的減少。這些節省的部分被與製造 365 天產品相關的預核准庫存成本所抵消。

Net loss was $78.6 million or a $0.12 loss per share in 2024 compared to net loss of $60.4 million or an $0.11 loss per share in 2023. Net loss increased by $18.2 million, primarily due to a reduction in gains due to the exchange of existing notes and gains driven by changes in the fair value of derivatives.

2024 年淨虧損為 7,860 萬美元，即每股虧損 0.12 美元，而 2023 年淨虧損為 6,040 萬美元，即每股虧損 0.11 美元。淨虧損增加了 1,820 萬美元，主要原因是現有票據交換產生的收益減少以及衍生性商品公允價值變動帶來的收益減少。

As of December 31, 2024, cash restricted cash and cash equivalents totaled $74.9 million and debt and accrued interest was $56.2 million.

截至 2024 年 12 月 31 日，現金限制現金和現金等價物總額為 7,490 萬美元，債務和應計利息為 5,620 萬美元。

Subsequent to year end we have been busy simplifying our capital structure and improving our balance sheet. In January, the remaining outstanding 2025 convertible notes in the principal amount of $20.4 million were repaid reducing the total principal debt outstanding to $35 million.

年底之後，我們一直忙於簡化資本結構和改善資產負債表。1 月份，剩餘未償還的 2025 年可轉換票據本金金額為 2,040 萬美元，已償還，使未償還本金債務總額降至 3,500 萬美元。

Additionally after year end all preferred stock has been converted into shares of common stock. The 12,000 shares of Series B preferred stock were converted into about 30.4 million shares of common stock at the end of January. The common shares issued have been included in our diluted earnings per share calculation since the preferred shares were issued.

此外，年底後所有優先股都已轉換為普通股。12,000股B系列優先股於1月底轉換為約3,040萬股普通股。自發行優先股以來，已發行的普通股已納入我們的稀釋每股盈餘計算中。

Finally, we received gross proceeds of approximately $27 million from the sale of common stock by utilizing our at the market facility which we expect will extend our cash runway into mid-2026 based on our current operating plans.

最後，我們利用市場機制出售普通股獲得了約 2,700 萬美元的總收益，根據我們目前的營運計劃，我們預計這將使我們的現金流量延長至 2026 年中期。

Turning to our outlook for 2025. We expect full year 2025 global net revenue to be approximately $34 million to $38 million as we continue to transition US patients to Eversense 365 following its launch in Q4.

展望 2025 年。我們預計 2025 年全年全球淨收入將達到約 3,400 萬至 3,800 萬美元，因為我們在第四季度推出 Eversense 365 後將繼續幫助美國患者轉向該服務。

The financial outlook takes into consideration several factors including: the timeline for the regulatory approval and the planned commercial launch of Eversense 365 outside the United States; continuing work to transition US reimbursement from Eversense E3 to Eversense 365; plans with respect to spending on the US direct to consumer marketing campaigns to generate leads; and the status of other sales and marketing initiatives.

財務前景考慮了幾個因素，包括：監管部門批准的時間表和 Eversense 365 在美國以外商業發布的計劃；繼續將美國報銷從 Eversense E3 過渡到 Eversense 365 的工作；關於在美國直接面向消費者的營銷活動上支出以產生潛在客戶的計劃；以及其他銷售和營銷計劃的狀態。

Also, we expect greater seasonality in our business with Eversense 365, influenced by annual insurance deductible limits and out of pocket costs resetting in January and the resulting utilization of patient assistance programs to offset those costs.

此外，我們預計 Eversense 365 業務的季節性會更強，受到年度保險免賠額限額和 1 月份重置的自付費用以及隨之而來的患者援助計劃利用來抵消這些成本的影響。

We expect to see a noticeable impact to our average selling price and therefore revenue and gross profit margins in the first half of each year as we account for the patient assistance program as a reduction to revenue. We anticipate notably more favorable average selling prices and therefore gross profit margins in the second half of the year.

我們預計，由於病患援助計畫導致收入減少，我們的平均售價以及每年上半年的收入和毛利率將受到明顯影響。我們預計下半年的平均銷售價格將更加優惠，因此毛利率也將更高。

The full year 2025 financial outlook assumes approximately doubling the global patient base in 2025 compared to 2024. We expect patients to grow steadily throughout the year but as a result of the seasonality and program impacts previously described we expect our revenue to be about one-third in the first half with the remaining two-third of revenue in the second half.

2025 年全年財務展望預計 2025 年全球患者數量將比 2024 年增加約一倍。我們預計患者數量將全年穩步增長，但由於先前描述的季節性和計劃影響，我們預計上半年的收入約為三分之一，下半年的收入為剩餘的三分之二。

We are excited about the unit economics of Eversense 365. Gross margins are expected to steadily increase each quarter in 2025 with four-year gross margins projected to be between 25% and 30%. We're also focused on continuing to be cost conscious and expect cash utilization in 2025 to be between $50 million and $60 million.

我們對 Eversense 365 的單位經濟效益感到興奮。預計 2025 年毛利率將每季穩定成長，四年毛利率預計在 25% 至 30% 之間。我們也專注於持續關注成本，預計 2025 年的現金利用率將在 5,000 萬美元至 6,000 萬美元之間。

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

說完這些，我就把話題轉回給提姆。

Thanks, Rick. After hearing from Brian and Rick, you can see why I'm excited about Senseonics' growth potential in 2025. We have strengthened our balance sheet and we are performing well on key performance indicators for the 365 launch in the US.

謝謝，里克。聽了 Brian 和 Rick 的演講後，您就會明白為什麼我對 Senseonics 在 2025 年的成長潛力感到興奮。我們已經加強了資產負債表，並且在美國推出 365 的關鍵績效指標方面表現良好。

We plan to commercialize Eversense 365 in Europe this year and we continue to build on the Eversense 365 technology platform to deliver Gemini and Freedom to patients in the upcoming years. The successful initial launch of a 365-day product represents one of the most significant catalysts in the company's history and we're looking forward for 2025 to be another transformational year for the company.

我們計劃今年在歐洲將 Eversense 365 商業化，並將繼續建構 Eversense 365 技術平台，以便在未來幾年為患者提供 Gemini 和 Freedom。365 天產品的成功首次推出是公司歷史上最重要的催化劑之一，我們期待 2025 年成為公司的另一個轉型之年。

The CGM market remains one of the most exciting spaces in medical devices. Our technology offers unique solutions to help people manage their diabetes. There is a large opportunity in front of us as we work to continue to simplify the lives of more people with diabetes and drive higher growth to build shareholder value.

CGM 市場仍然是醫療器材領域最令人興奮的領域之一。我們的技術提供獨特的解決方案來幫助人們控製糖尿病。當我們努力繼續簡化更多醣尿病患者的生活並推動更高的成長以創造股東價值時，我們面前存在著巨大的機會。

In addition to Rick, Brian, and myself, joining us for questions today is Mukul Jain, our Chief Operating Officer. Thank you all for your time today. Operator, let's now open up the call for questions.

除了 Rick、Brian 和我之外，我們的營運長 Mukul Jain 今天也與我們一起回答問題。感謝大家今天的寶貴時間。接線員，我們現在開始提問。

(Operator Instructions) Mathew Blackman, Stifel.

（操作員指示） Mathew Blackman，Stifel。

Hey, Rick. Hi, Tim. A quick question on the OUS launch plan for later in the year. You've had a couple iterations with 180 and 365 in the US and we've seen these inventory building dynamics happen. What should we expect when you take it OUS? Should we expect a similar type of inventory stocking or is that going to be a more gradual thing that you do over time?

嘿，瑞克。你好，提姆。關於今年稍後的 OUS 發布計劃，我有一個簡短的問題。您在美國已經進行了 180 和 365 的幾次迭代，我們已經看到了這些庫存建設動態的發生。當您服用 OUS 時我們應該期待什麼？我們是否應該期待類似類型的庫存儲備，或者這將是隨著時間的推移而逐漸發生的事情？

Now, we anticipate that it'll be more gradual as Rick already alluded to. Even building in the US we do expect it to be frankly three or four more months before we get to the planned level. And in Europe we would plan to build pretty conservatively as well.

現在，我們預計它會更加漸進，正如 Rick 已經提到的那樣。即使在美國建設，我們預計還需要三到四個月的時間才能達到計劃的水平。在歐洲，我們也計劃採取相當保守的建設方式。

Got you. And then quickly on Mercy -- that you guys have been inserting 365-day sensors for around a quarter now at least. What are you seeing on the ground relative to what you've seen in other offices and how are you thinking about the prescriber base going forward whether it be people in the Mercy system, [endos], [PCPs], what are you seeing with regard to 365-day insertion? Thank you.

明白了。然後快速談談 Mercy —— 你們至少已經插入了大約一個季度的 365 天感測器。與您在其他診所看到的情況相比，您在當地看到了什麼？您如何看待未來的處方者群體，無論是 Mercy 系統中的人員、[內分泌科醫生]、[PCP]，您對 365 天插入的情況有何看法？謝謝。

So from the patient and physicians there continues of course to be a lot of excitement around 365 as we talked about. The use attributes, the once a year sensor, and the single calibration of week continue to win the day for us.

因此，正如我們所說的，患者和醫生對 365 仍然感到非常興奮。使用屬性、每年一次的感測器以及每週一次的校準繼續為我們贏得勝利。

We have transitioned from the early work we did was on the endocrinology side with the Mercy system and we have opened it up for about the last month to primary care which is frankly where we expect to see.Most of the patients coming in as these are predominantly Type 2 patients that are either on MDI or basal insulin.

我們早期的工作是利用 Mercy 系統進行內分泌學的研究，大約在上個月，我們將其開放給初級保健，坦白說，這正是我們所期望看到的。大多數患者來這裡主要是使用 MDI 或基礎胰島素的 2 型患者。

So there's quite a bit of reach out that we that we need to continue to do as we've expanded to the much larger population. So we'll certainly continue to work on that over the next coming quarters but we're encouraged with the early signs that we're seeing but also do have quite a bit more work to do as we go to the broader prescriber population.

因此，隨著我們服務範圍擴大到更大的人群，我們需要繼續進行更多的工作。因此，我們肯定會在接下來的幾個季度繼續致力於此，但我們對所看到的早期跡象感到鼓舞，但隨著我們面向更廣泛的處方人群，我們還有很多工作要做。

Thanks for taking my questions. Congrats on the nice quarter.

感謝您回答我的問題。恭喜本季取得良好成績。

Thank you.

謝謝。

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞。

Hi, thank you for taking the question. So I had a couple. One was I was hoping just to clarify, I think on the pre-announcement a few weeks ago you said you had over 1,000 prescribers in the US and then this one you talked about 2,400. So was it over 1,000 just in precise and 2,400 was where you were a month ago or or have you had a large increase in the prescribers in the recent weeks?

您好，感謝您回答這個問題。所以我有幾個。一是我希望澄清一下，我記得在幾週前的預先公告中您說過您在美國有超過 1,000 名處方人員，而這次您又說有 2,400 名。那麼，確切地說是不是超過 1,000 了，一個月前是 2,400 了，還是最近幾週處方量有大幅增加？

We certainly had an increase. Not to that size, Rick, do you want to go ahead and and clarify the numbers?

我們的數字確實有所成長。沒有那麼大，里克，你想繼續澄清這些數字嗎？

Yeah, I think the the 1,000 was prescribers since launch where the 2,400 was an annual number of prescribers? So that's probably the difference that you're seeing.

是的，我認為 1,000 是自推出以來的開處方人數，而 2,400 是每年的開處方人數？這可能就是您所看到的區別。

Okay. And just on the guidance and with the dynamics in Europe and the US, could you talk to how much of the revenue growth you expect to come from international versus the US and what should we -- could you help us with the forecast in Europe before you launch the new product?

好的。僅根據指導以及歐洲和美國的動態，您能否談談您預計有多少收入增長來自國際市場而不是美國市場，以及我們應該怎麼做——您能否在推出新產品之前幫助我們預測歐洲的情況？

Certainly. Most of the growth will continue to come from the US as we've seen in in 2024. That said, we do expect a significant rate of increase when we launch the 365-day product in Europe in the second half of the year.

當然。正如我們在 2024 年所看到的，大部分成長仍將來自美國。話雖如此，我們確實預計，當我們在今年下半年在歐洲推出 365 天產品時，成長率會大幅提高。

So most of the investment with Brian and his team is in the view in the US initiatives but we will certainly ramp those up as a new product becomes available in Europe when we get to market.

因此，Brian 和他的團隊的大部分投資都集中在美國計劃上，但隨著新產品進入歐洲市場，我們肯定會加強投資。

Maybe I'll just squeeze in one more just on the prescribers. I mean just thinking about those numbers it seems like rough estimates you're seeing about and per prescriber in the US?

也許我只需要再擠一點時間就可以開處方了。我的意思是，僅僅考慮這些數字，您看到的似乎是關於美國每個處方醫生的粗略估計？

In terms of what you're forecasting, I was just wondering if you could comment on kind of the shape of your prescriber base. Are there some really heavy prescribers? Are you seeing most folks do that kind of average or what does that look like?

就您的預測而言，我只是想知道您是否可以評論一下您的處方者基礎的形態。是否存在一些開藥量很大的醫師？您是否看到大多數人都這樣做平均數或那是什麼樣子的？

It's truly a distribution. Brian, do you want to speak to that?

這確實是一種分佈。布萊恩，你想談談這件事嗎？

Yeah, I do think that's the proper answer. Because we do a lot of direct to consumer advertising, about half of our inbound businesses from direct to consumer advertising, we do get a lot of new prescribers. We do get a lot of the primary care physicians where that patient is expressing interest from and therefore we connect with that physician and quite honestly then they become a new prescriber.

是的，我確實認為這是正確答案。由於我們做了很多直接面向消費者的廣告，大約有一半的業務來自直接面向消費者的廣告，我們確實獲得了許多新的處方者。我們確實聯繫了許多初級保健醫生，患者對他們表達了興趣，因此我們與這些醫生取得了聯繫，然後坦白地說，他們就成為了新的處方醫生。

We do have a couple of very large clinics that have multiple prescribers in them and they are doing a much higher volume. So the goal obviously is to take those individual onesie, twosies and now that we've driven awareness through capturing a patient or two in their practice make them bigger prescribers, believers, bring them on board.

我們確實有幾家非常大的診所，裡面有多名開處方的醫生，而且他們的診療量要大得多。因此，我們的目標顯然是讓這些個體穿上連身衣、兩件衣服，現在我們已經透過在他們的實踐中捕捉一兩個病人來提高認識，讓他們成為更大的處方者、信徒，讓他們加入進來。

And then there's some in the middle, clearly, an endocrinologist that's doing 6, 8, 10 here or there but it is truly a distribution throughout with a couple of very large ones and a lot of ones they choose, especially on the Senseonics' for us Type 2s.

然後還有一些處於中間的，顯然，內分泌學家在這裡或那裡做 6、8、10 個，但它確實是一個分佈，有幾個非常大的和很多他們選擇的，特別是對我們 2 型 Senseonics 來說。

Got you. Okay, great. Thanks for the color; that's helpful.

明白了。好的，太好了。謝謝你的顏色；這很有幫助。

Marie Thibault, BTIG.

Marie Thibault，BTIG。

Hi, good afternoon. Thanks for taking the questions. Wanted to ask here for just a more qualitative or detailed update on the reimbursement efforts, especially at Medicare. What is sort of where are we in the transition to the 365 day? I know there's always a little bit of details that need to be worked out.

嗨，下午好。感謝您回答這些問題。只是想在這裡詢問有關報銷工作的更定性或更詳細的更新信息，特別是在醫療保險方面。我們在向 365 天過渡的過程中處於什麼位置？我知道總是有一些細節問題需要解決。

So when in the year do you expect that the majority of Medicare patients will be able to get reimbursement for 365?

那麼您預計大多數醫療保險患者何時能夠獲得 365 天的報銷？

It's a good question. We're actually working on that arduously right now, Marie. We actually have the -- G-codes have been published so reimbursement is available to all patients on Medicare. What we're actually working with is the max on the pricing for that.

這是個好問題。瑪麗，我們現在確實正在努力解決這個問題。我們實際上已經發布了 G 代碼，因此所有享有醫療保險的患者都可以獲得報銷。我們實際上正在考慮的是其最高定價。

So there's a process that we were that we're going through. We certainly -- some of the government dynamics that are going on in regards to the ability to meet are impacting that schedule but we're continuing to push through and get that pricing all in place.

所以我們正在經歷一個過程。當然，政府在滿足會議能力方面正在發生的一些動態正在影響該計劃，但我們正在繼續努力，並讓所有定價都落實到位。

So we're working with the prescribers and the reimbursement we're doing it ourselves with our Eon care services so we have the coverage we're working on the the pricing level and I anticipate that'll get resolved over the next quarter or so.

因此，我們正在與處方人員合作，並透過 Eon 護理服務自行進行報銷，這樣我們就可以獲得覆蓋範圍，我們正在研究定價水平，我預計這將在下個季度左右得到解決。

Okay, so I don't know if you want to add anything about. Right, Brian, I don't know if you want any more on commercial plans. We certainly have had some success but we've also got some more working on there as well.

好的，我不知道您是否想補充一些內容。好的，布萊恩，我不知道您是否想要更多商業計劃。我們確實取得了一些成功，但我們還需要做更多的工作。

Yeah, I think that's spot on.

是的，我認為說得很對。

Okay, great. And then maybe I could ask for a little bit more quantitative detail as well on the spending side. You've talked about cutting about $10 million year every year on cash OpEx and I know of course R&D and things, there might be some investments coming near the year end with Gemini.

好的，太好了。然後，也許我可以要求提供有關支出方面的更多量化細節。您談到每年削減約 1000 萬美元的現金營運支出，我當然知道研發和其他方面，年底前可能會對 Gemini 進行一些投資。

So just help us think through the cadence of some of this, especially as you go DTC, do some of these efforts -- how we should be thinking about the OpEx cadence throughout the year? Thanks for taking the questions

因此，請幫助我們思考其中的一些節奏，特別是當您採用 DTC 時，做一些這樣的努力——我們應該如何考慮全年的 OpEx 節奏？感謝您回答問題

Sure. And remember, Marie, as I know you're aware, right, the sales and marketing expenses are coming from predominantly from Ascensia so you know we won't be speaking to that to their part of the contribution. But Rick, I'll let you go through the cadence of expense for us mostly driven by that R&D worker.

當然。請記住，瑪麗，我知道您知道，銷售和行銷費用主要來自 Ascensia，所以您知道我們不會談論他們的貢獻部分。但是里克，我會讓你了解我們主要由研發人員推動的開支節奏。

Right, from the SG&A perspective, Marie, it's pretty linear across quarters. It does increase slightly with those sales commissions that are a result of the consignment program and that's success. And then from an R&D perspective when we start the Gemini Pivotal trial, once we get that ID approval later in the year there will be a slight increase to R&D.

是的，瑪麗，從銷售、一般及行政費用的角度來看，各季度之間的變化相當線性。由於寄售計劃的實施，銷售佣金確實略有增加，這是成功的。然後從研發的角度來看，當我們開始 Gemini Pivotal 試驗時，一旦我們在今年稍後獲得 ID 批准，研發就會略有增加。

And it does appear that there are no further questions at this time. I would now like to turn it back to management for any additional or closing remarks.

目前看來沒有其他問題了。現在我想將發言權交還給管理階層，請他們發表補充意見或結語。

Well, great, I appreciate everybody's time this afternoon. I appreciate everyone's excitement about 365. We certainly are and as you've heard our focus absolutely is continuing to build the best product we can.

好吧，太好了，感謝大家今天下午抽出時間。我感謝大家對 365 的興奮。我們當然是的，正如您所聽到的，我們的重點絕對是繼續打造最好的產品。

Obviously quarter-by-quarter revenue performance is important for us but the long term picture here is to have this highly differentiated product and make it as absolutely successful as we can both with the current 365 and the future generations -- Gemini and Freedom -- that we are very excited about.

顯然，逐季的營收表現對我們來說很重要，但長期目標是擁有這款高度差異化的產品，並儘可能使其在當前的 365 和未來幾代產品（Gemini 和 Freedom）上取得絕對的成功，我們對此感到非常興奮。

We know that many are in the space as well. So we look forward to continuing to report on that, progress with pump partners, as well as the future progress with Gemini Freedom and we look forward to updating you in the coming quarters. So with that, thanks, all.

我們知道還有很多人也處於這個領域。因此，我們期待繼續報告與泵浦合作夥伴的進展以及 Gemini Freedom 的未來進展，並期待在未來幾季向您通報最新情況。所以，謝謝大家。

This does conclude today's program. Thank you for your participation. You might disconnect at any time and have a wonderful evening.

今天的節目到此結束。感謝您的參與。您可以隨時斷開連接並度過美好的夜晚。