Senseonics Holdings Inc (SENS) 2025 Q1 法說會逐字稿

Good day, everyone. Welcome to the Senseonics first-quarter 2025 earnings call.

大家好。歡迎參加 Senseonics 2025 年第一季財報電話會議。

(Operator Instructions) Please note this call is being recorded. (Operator Instructions)

（操作員指示）請注意，此通話正在錄音。（操作員指示）

It is now my pleasure to turn the conference over to Jeremy Feffer from LifeSci Advisors. Please go ahead.

現在我很高興將會議交給 LifeSci Advisors 的 Jeremy Feffer。請繼續。

Thank you. This is Jeremy Feffer from LifeSci Advisors.

謝謝。我是 LifeSci Advisors 的 Jeremy Feffer。

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.

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 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 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.

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、10-Q 表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的投資者關係部分（www.senseonics.com）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更新、公開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.

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。

I'll now turn the call over to Tim Goodnow, President and CEO. Tim?

現在我將把電話轉給總裁兼執行長提姆·古德諾。提姆？

Thanks, Jeremy. Thank you to everyone on the call for joining us.

謝謝，傑里米。感謝電話會議中所有人的參與。

Today, I'm happy to add detail about our latest step in transforming diabetes care, the integration of our Eversense 365 continuous glucose monitor with Sequel's twiist automated insulin delivery system. I'll also provide an update on our recent CE Mark submission, our European launch planning, our pipeline programs, and our ongoing initiatives for practice and healthcare systems integration.

今天，我很高興詳細介紹我們在轉變糖尿病護理方面的最新舉措，即將我們的 Eversense 365 連續血糖監測儀與 Sequel 的 twiist 自動胰島素輸送系統相結合。我還將提供有關我們最近的 CE 標誌提交、我們的歐洲發布計劃、我們的管道計劃以及我們正在進行的實踐和醫療保健系統整合計劃的最新資訊。

After that, Rick will run you through the numbers. And then, we'll take your questions.

之後，瑞克會向你介紹這些數字。然後，我們將回答您的問題。

We announced on, April 29, our first AID integration of Eversense 365 with the twiist automated insulin delivery system. This partnership enables real-time readings from our CGM to be received by the twiist pump, which were then used in the loop algorithm to automatically adjust insulin delivery and predict future glucose levels.

我們於 4 月 29 日宣布首次將 Eversense 365 與 twiist 自動胰島素輸送系統進行 AID 整合。透過這種合作關係，twiist 幫浦可以接收我們 CGM 的即時讀數，然後在循環演算法中使用這些讀數自動調整胰島素輸送並預測未來的血糖水平。

We're excited about this collaboration, particularly joining the most technologically-advanced innovations in pump, CGM, and algorithm technologies. And we see this as a significant step forward for both companies towards improving personalization, choice, and improved health outcomes for patients with diabetes.

我們對此次合作感到非常興奮，特別是加入泵浦、CGM 和演算法技術領域最先進的創新。我們認為，這是兩家公司在改善糖尿病患者的個人化、選擇性和健康狀況方面邁出的重要一步。

We believe this compatibility will enhance the patient's experience through simplification of insulin delivery. And, with only one CGM required over the course of a year, patients will experience significantly less complexity in managing their diabetes.

我們相信，這種相容性將透過簡化胰島素輸送來增強患者的體驗。而且，由於一年內僅需進行一次 CGM 檢查，患者的糖尿病管理將變得簡單得多。

The teams are working on the systems integration. And we look forward to jointly launching our combined products in the coming quarter.

這些團隊正在致力於系統整合。我們期待在下一季聯合推出我們的組合產品。

The other collaboration we established during the quarter is with SweetSpot, which enables endocrinology practices to provide virtual CGM monitoring and enhance patient care. By receiving real-time CGM data from a patient's Eversense 365 through SweetSpot's technology platform, providers can assess and make treatment decisions between patient appointments and keep patients more connected to their care teams.

我們在本季建立的另一個合作關係是與 SweetSpot 合作，這使得內分泌科能夠提供虛擬 CGM 監測並加強病患照護。透過 SweetSpot 的技術平台從患者的 Eversense 365 接收即時 CGM 數據，醫療服務提供者可以在患者預約之間評估並做出治療決策，並讓患者與護理團隊保持更緊密的聯繫。

Endocrinologist practices can utilize SweetSpot's platform to capture reimbursable care events, improving efficiency and streamlining the totality of patient care.

內分泌科醫生可以利用 SweetSpot 的平台來捕捉可報銷的護理事件，提高效率並簡化整個患者護理。

We believe this benefit will be particularly useful for [accountable] care organizations and health systems looking to improve network-wide health outcomes that decrease costs.

我們相信，這項好處對於尋求改善全網路健康結果並降低成本的[負責任的]護理組織和衛生系統特別有用。

Our key accounts teams continue to work with health systems to include Eversense 365 in their standard offering for patients with diabetes to monitor and improve overall glycemic control and reduce the frequency and cost of long-term complications due to diabetes.

我們的大客戶團隊繼續與醫療系統合作，將 Eversense 365 納入其為糖尿病患者提供的標準服務中，以監測和改善整體血糖控制，並減少糖尿病長期併發症的頻率和成本。

We are engaged in a series of discussions to that end.

為此，我們正在進行一系列討論。

At the same time, Mercy Health Systems, in St. Louis, has recently undergone a significant executive level restructuring, which has caused them to pause many new initiatives, as they evaluate programs within this new structure.

與此同時，聖路易斯的 Mercy Health Systems 最近經歷了重大的高階主管層級重組，這導致他們暫停了許多新舉措，因為他們正在評估新架構下的專案。

While this was a broader action that does not reflect on Eversense, it does mean that the ongoing work to drive our Eversense with remote patient monitoring, offering [forward], at Mercy is currently on hold. And we do not yet have an estimate as to when the project will be restarted.

雖然這是一項更廣泛的行動，並不反映在 Eversense 上，但它確實意味著，在 Mercy 推動 Eversense 與遠端患者監控相結合的持續工作目前處於暫停狀態。我們目前還無法確定該項目何時能夠重新啟動。

Progress on the program, to date, has given us valuable insights about such an integration and the RPM element of the program. We expect this to benefit us, as we move forward with other health system initiatives.

迄今為止，該計劃的進展為我們提供了有關此類整合以及該計劃的 RPM 要素的寶貴見解。隨著我們推進其他醫療系統計劃，我們期望這將使我們受益。

As the program is expanded, we had planned to see Mercy impact the back half of the year. However, with the progress we are seeing with the 365 launch, the expected European launch and additional marketing initiatives planned, we reiterate the 2025 revenue guidance we've previously issued.

隨著計劃的擴大，我們計劃看到 Mercy 對今年下半年產生影響。然而，隨著 365 的推出、預期的歐洲發布以及計劃中的額外行銷活動取得進展，我們重申先前發布的 2025 年收入指引。

These complicated collaborations do take several quarters to implement. But we continue to expect these types of partnerships to be an important part of our growth strategy in the coming years.

這些複雜的合作確實需要幾個季度才能實現。但我們仍然期望這些類型的合作夥伴關係成為未來幾年我們成長策略的重要組成部分。

Looking at these Eversense 365 expansion opportunities, we filed our CE Mark application with a notified body in the first quarter. The review appears to be progressing, as expected. And, subject to receiving the anticipated approval, we remain on track for a European launch in the second half of this year.

考慮到這些 Eversense 365 擴展機會，我們在第一季向公告機構提交了 CE 標誌申請。正如預期的那樣，審查似乎正在取得進展。並且，在獲得預期批准的前提下，我們仍有望在今年下半年在歐洲推出該產品。

Our commercial partner, Ascensia Diabetes Care, has initiated the planning and preparation for this launch. We look forward to users in our European markets being able to experience the convenience of a one-year CGM. And our current expectation is that the Eversense 365 will be our single product offering by the end of 2025, offering meaningful global supply chain synergies and cost of goods improvements.

我們的商業合作夥伴 Ascensia Diabetes Care 已啟動此次發布的規劃和準備工作。我們期待歐洲市場的使用者能夠體驗到一年期 CGM 的便利性。我們目前的預期是，到 2025 年底，Eversense 365 將成為我們提供的單一產品，提供有意義的全球供應鏈協同效應和商品成本改進。

Our commercial accomplishments in Q1 were all made possible by delivering on our promise of one-year one CGM. We continue to make good on our progress on our work with US payers to transition reimbursement from 180 to 365 days for Eversense, with many payers having already transitioned their coverage.

我們在第一季取得的商業成就都是透過兌現一年一份 CGM 的承諾而實現的。我們繼續與美國付款人合作，將 Eversense 的報銷期從 180 天延長至 365 天，並取得進展，許多付款人已經完成了保險範圍的轉換。

Specifically, on the Medicare front, last month, we were happy to see that the 2025 physician fee schedule was updated to provide payment for our full year of Eversense, with effectiveness retroactive back to January 1.

具體來說，在醫療保險方面，上個月，我們很高興看到 2025 年醫師收費表已更新，以支付我們全年的 Eversense 費用，其有效性可追溯至 1 月 1 日。

We see many patients and providers enthusiastically embracing Eversense 365. And we continue to hear feedback on its convenience of ease of use. We look forward to continuing to build more awareness and adoption of the product throughout the year.

我們看到許多患者和提供者熱情地接受 Eversense 365。我們不斷聽到有關其易用性的回饋。我們期待全年繼續提高該產品的知名度和採用率。

I'd also like to highlight the importance of our continued work on our pipeline products, Gemini and Freedom, as our development team work diligently to continuously improve the patient's experience with Eversense.

我還想強調我們繼續致力於我們的管道產品 Gemini 和 Freedom 的重要性，因為我們的開發團隊正在努力不斷改善患者使用 Eversense 的體驗。

We remain on track to submit an IDE for a pivotal study, by year-end, for Gemini, using the data we are currently collecting in our human feasibility studies. The Gemini product includes a one-year sensor with a built-in battery that allows for both continuous, as well as optional, swipe testing, providing for more flexibility and choice for patients, who decide when and where they want to wear something on body.

我們仍計劃在年底前為 Gemini 提交一項關鍵研究的 IDE，使用我們目前在人類可行性研究中收集的數據。Gemini 產品包含一個內建電池的可使用一年的感測器，可進行連續且可選的滑動測試，為患者提供更多的靈活性和選擇，讓他們可以決定何時何地在身上佩戴某種東西。

Our Freedom system, which incorporates Bluetooth within the sensor to eliminate the need for any on-body transmitter is right behind and is built on the same sensing chemistry as the Eversense 365 and the Eversense Gemini. Freedom is designed to communicate, directly, with the user's phone to create the world's first and only invisible CGM. This offers the benefits of being able to monitor their glucose levels for an entire year, without any on-body device or adhesive.

我們的 Freedom 系統在感測器中整合了藍牙，從而無需任何身體發射器，並且基於與 Eversense 365 和 Eversense Gemini 相同的感測化學原理構建。Freedom 的設計目的是直接與使用者的手機進行通信，以創建世界上第一個也是唯一一個隱形的 CGM。這樣做的好處是，無需任何身體設備或黏合劑，就能監測他們一整年的血糖水平。

I think it's easy to understand why we call this project Freedom. And our team is driving hard to advance this development. Over the next few quarters, we expect to share more collaborations, partnerships, and development advances with you.

我想很容易理解為什麼我們將這個項目稱為「自由」。我們的團隊正在努力推動這項發展。在接下來的幾個季度裡，我們期待與您分享更多的合作、夥伴關係和發展進展。

Our goal remains to transform the lives in the global diabetes community through technologically-differentiated long-term implantable glucose monitoring. And, with each new collaboration, each technology interface and device integration and with each development milestone, we move one step closer to that goal.

我們的目標仍然是透過技術差異化的長期植入式血糖監測來改變全球糖尿病患者的生活。而且，隨著每一次新的合作、每一次技術介面和設備整合以及每一個發展里程碑，我們都朝著這一目標邁進了一步。

Now, I'll turn it over to Rick to walk you through the financials from the quarter.

現在，我將把時間交給 Rick，讓他向您介紹本季的財務狀況。

Thank you, Tim. Thanks to everyone joining us this afternoon.

謝謝你，提姆。感謝今天下午加入我們的各位。

In the first quarter of 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period. US revenue for the first quarter was $4.5 million and revenue outside the US was $1.8 million.

2025 年第一季度，淨收入較去年同期的 500 萬美元成長 24%，達到 630 萬美元。第一季美國營收為 450 萬美元，美國以外營收為 180 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.

與往常一樣，關於我們的收入確認，需要快速提醒一下：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。

For most sales, we recognize our portion of revenue, when shipments are delivered to Ascensia. This begins the distribution to patients via Ascensia and their distributors. We manage our manufacturing based on patient demands generated from commercial activities, targeting 60 to 90 days of inventory across the various channels. Therefore, our shipments to Ascensia during the quarter are largely intended to support future demand for Eversense.

對於大多數銷售，當貨物交付給 Ascensia 時，我們確認我們的收入份額。這開始透過 Ascensia 及其分銷商向患者分發。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。因此，我們本季向 Ascensia 的出貨主要是為了支持 Eversense 未來的需求。

Following the launch of Eversense 365, we are still increasing inventory levels and continue to expect to reach target levels by the end of Q2 2025.

在推出 Eversense 365 之後，我們仍在增加庫存水平，並預計到 2025 年第二季末達到目標水平。

We also sell product through an office consignment program and continue to see strong utilization in Q1, with approximately 13% of our revenue flowing through this channel.

我們也透過辦公室寄售計畫銷售產品，並在第一季繼續保持強勁的利用率，約有 13% 的收入來自該通路。

We have well over 100 healthcare providers participating in the consignment program, which enables the physician to have the product on the shelves, providing convenience to health care providers and patients, facilitating faster and even same-day insertions.

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，為醫療保健提供者和患者提供便利，促進更快甚至當天插入。

In the consignment program, we recognize revenue at the time of the procedure.

在寄售計畫中，我們在辦理手續時確認收入。

We also record a sales commission expense for Ascensia support with sales and marketing efforts on the revenue through this channel.

我們也記錄了 Ascensia 透過該管道對銷售和行銷工作提供支援的銷售佣金費用。

In Q1 2025, gross profit was $1.5 million, an increase from a gross profit of $0.3 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 $0.4 million in manufacturing costs previously expensed to research and development, prior to FDA approval of Eversense 365.

2025 年第一季度，毛利為 150 萬美元，較去年同期的 30 萬美元增加。毛利的成長主要得益於 365 天產品利潤率的提高，但也包括 FDA 批准 Eversense 365 先前用於研發的約 40 萬美元製造成本的正面影響。

When we include these costs in our gross profit margin calculation, we would see margins of approximately 18%. This is very encouraging, considering that we still have limited manufacturing scale, with it being so early in the product life cycle 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，我們會看到利潤率約為 18%。這是非常令人鼓舞的，考慮到我們的生產規模仍然有限，產品生命週期還處於早期階段，而且歐洲的銷售仍然是利潤率較低的 180 天產品。

Also, seasonality with our business because of higher utilization of our patient assistance programs to offset patient deductibles early in the year reduce our ASPs and, therefore, our margins.

此外，由於我們更多地利用患者援助計劃來抵消年初的患者免賠額，因此我們的業務具有季節性，從而降低了我們的平均銷售價格，從而降低了我們的利潤率。

Research and development expenses in Q1 2025 were $7.3 million, a decrease of $3.1 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.

2025 年第一季研發費用為 730 萬美元，較去年同期減少 310 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。

First-quarter 2025 selling, general, and administrative expenses were $7.7 million, a decrease of $0.4 million compared to $8.1 million in the prior year period, primarily driven by favorable personnel costs, consulting fees, and legal expenses.

2025 年第一季銷售、一般和行政費用為 770 萬美元，與去年同期的 810 萬美元相比減少 40 萬美元，主要由於人員成本、諮詢費和法律費用有利。

Net loss was $14.3 million or a $0.02 loss per share in the first quarter of 2025 compared to a net loss of $18.9 million or a $0.03 loss per share in the first quarter of 2024. Net loss decreased by $4.6 million, primarily due to improved gross profit margins of Eversense 365 and reduced research and development costs.

2025 年第一季淨虧損為 1,430 萬美元，即每股虧損 0.02 美元，而 2024 年第一季淨虧損為 1,890 萬美元，即每股虧損 0.03 美元。淨虧損減少460萬美元，主要由於Eversense 365毛利率提高和研發成本降低。

As of March 31, 2025, cash, restricted cash, and cash equivalents totaled $64.6 million; and debt and accrued interest was $35.3 million.

截至 2025 年 3 月 31 日，現金、受限現金及現金等價物總額為 6,460 萬美元；債務及應計利息為 3,530 萬美元。

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.

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, in Q1, all preferred stock was 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，在第一季度，所有優先股都轉換為普通股。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, in Q1, 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，在第一季度，我們利用市場融資工具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延長至 2026 年中期。

Reiterating our outlook for 2025, we expect full-year 2025 global net revenue to be approximately $34 million to $38 million, as we progress the launch of Eversense 365. This financial outlook takes into consideration several factors:

我們重申對 2025 年的展望，隨著 Eversense 365 的推出，我們預計 2025 年全年全球淨收入約為 3,400 萬至 3,800 萬美元。這個財務前景考慮了幾個因素：

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.

監管部門批准和 Eversense 365 在美國以外商業發布的時間表、繼續將美國報銷從 Eversense E3 過渡到 Eversense 365 的工作、有關在美國直接面向消費者的營銷活動上花費以產生潛在客戶的計劃，以及其他銷售和營銷計劃的狀態。

The full-year 2025 financial outlook assumes approximately doubling the global patient base in 2025 compared to 2024, with patients growing steadily throughout the year.

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，並且全年患者數量將穩定成長。

We expect our revenue to be approximately one-third in the first half, with the remaining two-thirds in the second half, as a result of the steady increase to patients and the ASP impact due to the seasonality of our business from program discounts previously described.

我們預計上半年的收入約為三分之一，下半年的收入將佔剩餘的三分之二，這是由於患者數量的穩定增長以及我們業務的季節性（如前所述的計劃折扣）對 ASP 的影響。

We are following the evolving tariff situation, closely, and monitoring how they could impact our gross profit margins. We have a global supply chain and utilize contract manufacturers for several manufacturing processes in Europe. And we obtain components and subcomponents from around the world, including a very small percentage from China, which could lead to a low single-digit impact to our gross profit margins.

我們正在密切關注不斷變化的關稅情況，並監控其如何影響我們的毛利率。我們擁有全球供應鏈，並利用合約製造商在歐洲進行多項製造流程。我們從世界各地採購零件和子零件，其中只有很小一部分來自中國，這可能會對我們的毛利率產生低個位數的影響。

Between the European piece of our business being largely sheltered from tariffs, utilization of industry exemptions, and some of the operational changes our supply chain has begun to implement, we expect to be able to mitigate any negative impact from tariffs to our gross profit margins.

由於我們的歐洲業務基本上不受關稅影響、利用產業豁免以及我們的供應鏈已開始實施的一些營運變革，我們預計能夠減輕關稅對我們毛利率的任何負面影響。

We continue to expect gross profit margins to steadily increase each quarter in 2025, with full-year gross margins projected to be between 25% and 30%.

我們繼續預計 2025 年每季的毛利率將穩定上升，全年毛利率預計在 25% 至 30% 之間。

We will continue to evaluate our supply chain and assess whether any aspects of our manufacturing processes could be performed efficiently in the US, as tariffs become clearer and the US represents a larger piece of our business.

隨著關稅變得更加清晰以及美國在我們的業務中所佔份額更大，我們將繼續評估我們的供應鏈，並評估我們的製造流程的任何方面是否可以在美國有效地進行。

We're also seeing the results of our expense management through lower operating expenses, which we continue to expect to translate into cash utilization between $50 million and $60 million in 2025.

我們也看到了透過降低營運費用來實現費用管理的成果，我們預計到 2025 年這將轉化為 5,000 萬至 6,000 萬美元之間的現金利用率。

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.

謝謝，里克。

We've had a busy start to the year at Senseonics. And we only expect to see the momentum continue with new announcements, new technical advances, new collaborations, and new customers.

Senseonics 的新一年伊始，我們過得非常忙碌。我們只希望看到這種勢頭隨著新公告、新技術進步、新合作和新客戶而繼續保持。

As the world's first and only one-year CGM, Eversense 365 is making a difference in patients' lives through simplification and peace of mind: the promise of one-year one CGM.

作為世界上第一個也是唯一一個一年期 CGM，Eversense 365 透過簡化和安心為患者的生活帶來改變：一年一個 CGM 的承諾。

Our launch metrics and revenue numbers give me confidence that we are on the right track, with this value proposition, to catalyzing growth for the company.

我們的發布指標和收入數字讓我相信，我們正走在正確的軌道上，透過這個價值主張，推動公司的成長。

From securing positive CMS reimbursement effective through January 1 to announcing the agreement for our first pump integration with Sequel’s twiist and announcing the collaboration with SweetSpot, we have made important progress to support Eversense 365 access and adoption.

從確保截至 1 月 1 日的積極 CMS 報銷到宣布與 Sequel 的 twiist 進行首次泵集成的協議以及宣布與 SweetSpot 合作，我們在支持 Eversense 365 訪問和採用方面取得了重要進展。

Further, we plan to launch Eversense 365 in Europe, this year, to bring the one-year one CGM promise to the people with diabetes in Europe.

此外，我們計劃今年在歐洲推出 Eversense 365，為歐洲糖尿病患者帶來一年一次的 CGM 承諾。

And we continue to build on our platform to deliver the further advances of Gemini and Freedom to users in the upcoming years.

我們將繼續建立我們的平台，在未來幾年為用戶提供 Gemini 和 Freedom 的進一步發展。

We hope you share our optimism and excitement in one of the fastest-growing segments in the medical device landscape.

我們希望您能與我們分享對醫療器材領域中成長最快的領域之一的樂觀和興奮。

Thank you, all, once again, for your time today.

再次感謝大家今天抽出時間。

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

接線員，我們繼續開始提問吧。

(Operator Instructions)

（操作員指示）

Anthony Petrone, Mizuho.

瑞穗的安東尼‧佩特羅內 (Anthony Petrone)。

Thanks. Congrats, again, on the E365 launch and a good start to the year here, overall.

謝謝。再次恭喜 E365 的發布，總體而言，今年有一個好的開始。

I think I want to, maybe, Tim, start on the guidance, intrigued there that -- actually raising the outlook, despite the pause on the Mercy contract and initiatives. And you mentioned the US trajectory being one driver but also OUS.

我想，也許，蒂姆，開始提供指導，對此很感興趣 - 儘管 Mercy 合約和計劃暫停，但實際上提高了前景。您提到美國的發展軌跡是一個驅動因素，但 OUS 也是一個驅動因素。

So, maybe, break those three buckets out a little bit. What were the initial expectations for Mercy that were baked in. And if you split between your early views here on trajectory US versus US, put it placing the offsets in those two buckets, how do we quantify those two?

因此，也許可以稍微將這三個桶子分開一下。最初對 Mercy 的期望是什麼？如果您將早期對美國軌蹟的看法與對美國的軌蹟的看法分開，並將其偏移量放在這兩個桶中，我們如何量化這兩個？

And then, I'll have a follow-up.

然後，我會進行跟進。

Sure. Thanks. Thanks for the time, as well.

當然。謝謝。也感謝您抽空。

Based on the early launch metrics that we've shared, we continue to see a very exciting response for the Eversense 365. We continue to have a good first quarter, as you saw.

根據我們分享的早期發布指標，我們繼續看到 Eversense 365 的非常令人興奮的反響。如您所見，我們第一季的業績繼續保持良好。

We're just excited about the conversion rates that we're seeing. We're excited about the interest that we're seeing. So all of the signals are certainly to the positive.

我們對所看到的轉換率感到非常興奮。我們對所看到的興趣感到非常興奮。所以所有訊號肯定都是正面的。

So as -- I would say yes, we did anticipate the ability to do more ramp with Mercy in the back half of the year. But that will certainly be moderated. And any risk that might have existed, it will be fully eliminated by the 365 launch.

所以 — — 我想說是的，我們確實預計今年下半年能夠利用 Mercy 做更多的提升。但這肯定會得到緩和。任何可能的風險都將透過 365 的推出徹底消除。

The OUS component will certainly add to that, as well. The progress that we're making with the reviewer notified [body's BSI] is right on schedule. And we certainly anticipate having that in the second half of the year, along the lines of what we've seen, what we've previously communicated.

OUS 組件肯定也會對此有所貢獻。我們與審查員通知[機構的 BSI] 所取得的進展正按計劃進行。我們當然預計今年下半年就會實現這一目標，就像我們所看到的和我們之前傳達的那樣。

The launch excitement in the US? We do expect to propagate outside the United States, as well. So we're hoping that there's some good opportunity with that, as well.

美國的發表會令人興奮嗎？我們確實也希望在美國以外傳播。因此，我們也希望這會帶來一些好的機會。

And then, based on the metrics that we're seeing with the conversions, especially around BTC and the performance of the sales reps, we know that if we increase awareness, which we will be doing, we're going to drive more sensors in, as well.

然後，根據我們看到的轉換指標，特別是圍繞 BTC 和銷售代表的表現，我們知道，如果我們提高知名度（我們將這樣做），我們也將引入更多的感測器。

So net-net, yeah, all those together, we're actually very excited with the launch, as it's going. And if there's a little bit of a speed bump with the slowdown of Mercy, as they go through some internal reorganizations, we're certainly going to blow right through that.

所以，是的，綜合起來，我們對這次發布的進展感到非常興奮。如果 Mercy 的發展速度因內部重組而放緩，出現一些障礙，我們肯定會立即克服它。

Maybe, the follow-up will just be on the DTC that you mentioned, here. Obviously, some of your competitors are out there -- pretty high profile, just in terms of their DTC efforts.

也許，後續只會關注您在這裡提到的 DTC。顯然，你們的一些競爭對手已經存在——僅從 DTC 努力來看，他們的知名度就相當高。

So what do those look like for Senseonics? What are the channels that you expect to penetrate, here, on DTC?

那麼對於 Senseonics 來說這些是什麼樣的呢？您期望在 DTC 上滲透哪些管道？

And then, when you think about just conversion on that, at the position level, when you segment just the target market for CGM, are there specific populations within that broader adult type 1, type 2 patient backdrop that you're really zoning in on, here, on for a 365 sensor

然後，當您考慮在位置層級進行轉換時，當您僅細分 CGM 的目標市場時，在更廣泛的成人 1 型、2 型患者背景中是否存在您真正關注的特定人群，在這裡，對於 365 感測器

Thanks, again. Congrats.

再次感謝。恭喜。

Sure. Yeah. The mediums that we focused on have been predominantly through the traditional social media. We've shown good success through Facebook. We've shown very good success through TikTok, as well as Instagram and YouTube, frankly.

當然。是的。我們關注的媒介主要是傳統社群媒體。我們已經透過 Facebook 取得了良好的成功。坦白說，我們透過 TikTok、Instagram 和 YouTube 取得了非常好的成功。

So we're able to very specifically geo-target. It helps with our individual sales reps and whatever success they may be having in their particular region.

因此我們能夠非常具體地進行地理定位。它對我們的個人銷售代表以及他們在特定區域所取得的成功有所幫助。

I would say that that will continue to be our investment.

我想說這將繼續是我們的投資。

The conversion that we're seeing, obviously, it's the people that are on insulin. We've seen especially good success, of late, in the Medicare population.

我們看到的轉變顯然是那些使用胰島素的人。近來，我們看到醫療保險人群取得了特別好的成功。

As you know, now having the reimbursement schedule up and in place and being able to document that for all of the providers is hugely valuable and takes any discussion in regards to economics off the table from the sales reps because it's very easy to see.

如您所知，現在製定並實施報銷計劃並能夠為所有提供者記錄下來是非常有價值的，並且使銷售代表不再討論經濟問題，因為它很容易看到。

So I would say that that's frankly probably been our best and those targeted advertisements for that population are leading the pack for us.

所以我想說，坦白說，這可能是我們最好的成績，而針對該人群的定向廣告對我們來說是領先的。

Much appreciated. Thank you.

非常感謝。謝謝。

Marie Thibault, BTIG.

Marie Thibault，BTIG。

Hey. Good afternoon, Tim and Rick. This is Sam, on for Marie. Thanks for taking the questions. Congrats to a nice start to the year.

嘿。下午好，提姆和里克。我是薩姆，代替瑪麗。感謝您回答這些問題。祝賀新的一年有一個好的開始。

Maybe, I could start on the twiist integration. Congratulations on that announcement. How much integration work is needed or that's left on your part to meet that Q3 timeline? And is this a channel where Ascensia is going to be pushing at all or is it really coming from twiist's own commercial team, here?

也許，我可以開始進行 twiist 整合。祝賀這一宣布。為了滿足第三季的時間表，需要做多少整合工作或您還需要做多少整合工作？這是 Ascensia 將要大力推廣的管道嗎？還是它真的來自 twiist 自己的商業團隊？

No. I think you're going to see an exciting partnership that's going to come from both sides. I think we'll show, at the ADA, a good interest of integration.

不。我認為你將會看到雙方建立令人興奮的合作關係。我認為，在 ADA 上，我們會表現出對融合的良好興趣。

And the teams are already working together, as we speak. It just so happens that Ascensia's sales -- the national sales meeting is next week and there's a good full participation from the Sequel team in that meeting, as well. So there's a lot of joint programs that are put together.

正如我們所說，各個團隊已開始合作。碰巧的是，Ascensia 的全國銷售會議將於下週舉行，Sequel 團隊也將全程參與會議。因此有很多聯合項目被整合在一起。

As two of the newer entrees in place with best-in-class technology from both platforms, we're really excited about the story that we're going to be able to tell.

作為兩個新晉品牌，我們擁有兩個平台的一流技術，對於即將要講述的故事，我們感到非常興奮。

The (inaudible) for a full year with that loop algorithm, highly-differentiated pump is going to be exciting to a lot of folks. And we're excited to see what we can to see what we can do with that.

（聽不清楚）整整一年的循環演算法、高度差異化的幫浦將會讓很多人興奮。我們很高興看到我們能用它做什麼。

Okay. Very good. [Any] integration work that's left or needed to be done?

好的。非常好。還有什麼整合工作要完成嗎？

Yeah. We're actively working together.

是的。我們正在積極合作。

The majority of the work still falls in verification and validation of the integrated system on the pump side. They're highly motivated to get that done. And I know that they're committed to get that out, here, in the third quarter.

大部分工作仍然在於泵側整合系統的驗證和確認。他們有很強的動力去完成這件事。我知道他們致力於在第三季實現這一目標。

So we've got just about a quarter, a little bit more work that needs to be done. And we're pretty excited about being able to keep that on schedule.

因此，我們只剩下大約四分之一的時間，還有一點點工作要完成。我們非常高興能夠按計劃完成這項任務。

Okay. That's helpful.

好的。這很有幫助。

And then, maybe, moving to the reimbursement side of things -- congrats on the Medicare policy update. Any update on how commercial plans are starting to convert over to 365 sensor and any targets on where you're hoping to be, maybe, three months from now and, possibly, by the end of the year?

然後，也許，轉到報銷方面——祝賀醫療保險政策更新。關於商業計劃如何開始轉換為 365 感測器，有任何最新消息嗎？以及您希望達到什麼目標，也許是從現在起三個月後，也可能是在今年年底前？

Yeah. Certainly. I would fully expect by the end of the year, even by the third quarter, to have the vast, vast majority of all the plans covered over, now. Quite frankly, a significant number have.

是的。當然。我完全相信，到今年年底，甚至到第三季度，絕大多數計畫都能夠落實。坦白說，有相當多的人確實這麼做了。

We have seen one or two of the commercial payers go from the [DME] channel to the buy-and-build channel, that consignment program that Rick referred to. So I think a little bit of consolidation towards what Medicare does, we may be seeing.

我們已經看到一兩家商業付款人從 [DME] 管道轉向購買和建造管道，即 Rick 提到的寄售計劃。因此，我認為我們可能會看到醫療保險制度有所整合。

But through that entire process, they are, of course, updating to the 365. So I would say that we're certainly more than halfway in that -- the 180 and 365 conversion. And I would expect, over the next quarter so, that that'll be in the 90% range.

但在整個過程中，他們當然會更新到 365。所以我想說，我們肯定已經完成了一半以上——180 和 365 的轉換。我預計，下一季這一比例將達到 90% 左右。

Got it. Okay. Very good. Thanks for taking the questions.

知道了。好的。非常好。感謝您回答這些問題。

Thank you. This concludes our Q&A session.

謝謝。我們的問答環節到此結束。

I will now turn the call over to Tim Goodnow for closing remarks.

現在我將把電話交給蒂姆·古德諾 (Tim Goodnow) 來做結束語。

Great. I'd like to thank everyone, again, for the time this afternoon.

偉大的。我想再次感謝大家今天下午抽出時間。

It's an exciting quarter for us to be able to announce the partnership with Sequel. It's a work that has been going on for some time. We're excited to see it, here, in front of us.

對我們來說，這是一個令人興奮的季度，能夠宣布與 Sequel 建立合作夥伴關係。這項工作已經進行了一段時間了。我們很高興看到它就在這裡，就在我們面前。

They are excited to launch their product; and to be able to offer that pump integration with our first partner is pretty exciting for us.

他們很高興推出他們的產品；並且能夠與我們的第一個合作夥伴一起提供泵集成，這對我們來說非常令人興奮。

So look for us at the ADA. I think you'll see a pretty good splash there.

因此請在 ADA 尋找我們。我想你會看到那裡一片美麗的景象。

We appreciate everybody's time this afternoon. Look forward to updating you, next quarter.

我們感謝大家今天下午抽出的時間。期待下個季度向您更新資訊。

So have a good day. Thanks, all.

祝您有美好的一天。謝謝大家。

Thank you.

謝謝。

This does conclude today's program.

今天的節目到此結束。

Thank you for your participation.

感謝您的參與。

You may disconnect at any time.

您可以隨時斷開連線。