Beta Bionics Inc (BBNX) 2025 Q3 法說會逐字稿

Good afternoon and welcome to the Beta Bionics third-quarter 2025 earnings conference call. (Operator Instructions) As a reminder, please be advised that today's conference is being recorded.

下午好，歡迎參加 Beta Bionics 2025 年第三季財報電話會議。（操作說明）提醒各位，本次會議正在錄音。

I would like to hand the conference over to Blake Beber, Head of Investor Relations. Please go ahead.

我謹將會議交給投資人關係主管布萊克‧貝伯。請繼續。

Good afternoon and thank you for tuning in to Beta Bionics' third-quarter 2025 earnings call. Joining me for today's call are Chief Executive Officer, Sean Saint; and Chief Financial Officer, Stephen Feider.

下午好，感謝收聽 Beta Bionics 2025 年第三季財報電話會議。今天與我一起參加電話會議的有執行長肖恩·聖和財務長史蒂芬·費德。

Both the replay of this call and the press release discussing our third-quarter 2025 results will be available on the Investor Relations section of our website. The replay will be available for approximately one year following the conclusion of this call.

本次電話會議的錄音回放以及有關我們 2025 年第三季業績的新聞稿都將在本公司網站的投資者關係版塊提供。本次電話會議結束後，錄音重播將保留約一年。

Information recorded on this call speaks only as of today, October 28, 2025. Therefore, if you are listening to any replay, any time sensitive information may no longer be accurate. Also on our website is our supplemental third-quarter 2025 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates.

本次通話記錄的資訊僅代表截至 2025 年 10 月 28 日的情況。因此，如果您收聽的是重播，任何時效性資訊可能不再準確。此外，我們的網站上還有 2025 年第三季補充收益簡報和更新後的公司簡報。我們建議您參考這些文件，以取得關鍵指標和業務更新的摘要。

Before we begin, we would like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect management's expectations about future events, our product pipeline, development timelines, financial performance, and operating plans.

在開始之前，我們想提醒各位，今天的討論將包含 1995 年《私人證券訴訟改革法案》所界定的前瞻性陳述。這些聲明反映了管理層對未來事件、產品線、開發時間表、財務表現和營運計劃的預期。

Please refer to the cautionary statements in the press release we issued earlier today, as well as our SEC filings, including our Form 10-Q filed today for a detailed explanation of the inherent limitations of such forward-looking statements. These documents contain and identify important factors that may cause actual results to differ materially from current expectations expressed or implied by our forward-looking statements.

請參閱我們今天早些時候發布的新聞稿中的警示性聲明，以及我們向美國證券交易委員會提交的文件，包括我們今天提交的 10-Q 表格，以詳細解釋此類前瞻性聲明的固有局限性。這些文件包含並指明了可能導致實際結果與我們前瞻性聲明中明示或暗示的當前預期有重大差異的重要因素。

Please note that the forward-looking statements made during this call speak only as of today's date, and we undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law.

請注意，本次電話會議中所作的前瞻性陳述僅代表截至今日的觀點，除法律要求外，我們不承擔更新這些陳述以反映後續事件或情況的義務。

Today's discussion will also include references to non-GAAP financial measures with respect to our performance, namely adjusted EBITDA. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods.

今天的討論還將包括提及與我們績效相關的非GAAP財務指標，即調整後的EBITDA。我們提供非公認會計準則財務指標，旨在向投資者提供我們認為能夠反映我們核心經營績效和持續業務營運的資訊。我們認為這些非GAAP財務指標有助於更好地比較不同報告期間的經營績效。

Any non-GAAP information presented should not be considered as a substitution independently or superior to results prepared in accordance with GAAP. Please refer to our earnings press release and supplemental earnings presentation on the Investor Relations section of our website for a reconciliation of non-GAAP measures to their most directly comparable GAAP financial measure.

任何根據非公認會計準則（non-GAAP）提供的資訊都不應被視為獨立於或優於根據公認會計準則（GAAP）編制的結果。有關非GAAP指標與其最直接可比較的GAAP財務指標的調節表，請參閱我們網站投資者關係部分的盈利新聞稿和補充盈利演示文稿。

With that, I'd now like to turn the call over to Sean.

接下來，我想把電話交給肖恩。

Thanks, Blake. Good afternoon, everyone, and thank you for joining.

謝謝你，布萊克。各位下午好，感謝各位的參與。

We're proud to share with you all today the details of our strong performance in the third quarter, as well as discuss our updated annual projections for the full year 2025.

今天，我們很榮幸與大家分享我們第三季強勁業績的詳情，並討論我們更新後的 2025 年全年年度預測。

Starting with our performance in the third quarter, we continue to make key advances across our business, both commercially and in our innovation pipeline. Demand for the iLet both in existing practices as well as new practices, continues to exceed our expectations, and in the third quarter, we saw a record number of both new patient starts as well as the percentage of those new patient starts going through the pharmacy channel.

從第三季的業績來看，我們在業務的各個方面，包括商業和創新研發方面，都持續取得關鍵進展。無論是現有診所還是新診所，對 iLet 的需求都持續超出我們的預期。第三季度，我們看到新患者數量以及透過藥房管道開始使用 iLet 的新患者比​​率均創下歷史新高。

The iLet's automation and adaptation continue to set a new standard for our industry, simplifying and alleviating the burden of managing diabetes for our users, their caregivers, and their healthcare providers. But we're not stopping there, and we're continuing to push the envelope on key innovations to our pipeline that I believe will enable Beta Bionics to disrupt ourselves in the future and deliver even more life-changing solutions to people with diabetes and the community that supports them.

iLet 的自動化和適應性不斷為我們的行業樹立新的標準，簡化並減輕了使用者、他們的照護者和他們的醫療保健提供者管理糖尿病的負擔。但我們不會止步於此，我們將繼續推動關鍵創新，為我們的研發管線注入新的活力。我相信，這將使 Beta Bionics 在未來能夠顛覆自我，並為糖尿病患者及其支持團體提供更多改變生活的解決方案。

During today's call, I'll begin by covering our Q3 results, which exceeded our expectations across the board. Stephen will then discuss our Q3 performance and updated full year 2025 guidance in more detail. Lastly, I'll share some exciting updates across our innovation pipeline, including iLet and some new features we recently rolled out; Mint, which is our patch pump in development; and lastly, our bihormonal system in development.

在今天的電話會議上，我將首先介紹我們第三季的業績，該業績全面超出了我們的預期。接下來，Stephen 將更詳細地討論我們第三季的業績以及更新後的 2025 年全年業績預期。最後，我將分享我們創新產品線的一些令人興奮的最新進展，包括 iLet 和我們最近推出的一些新功能；Mint，我們正在開發的貼片幫浦；以及我們正在開發的雙激素系統。

Let's begin with an overview of our Q3 2025 performance. I'm pleased to share that we delivered $27.3 million in net sales, which grew 63% year over year. Q3 revenue growth was predominantly driven by 5,334 new patient starts in the quarter, which grew 68% year over year, as well as our growing installed base of users accessing their monthly supplies for the iLet through the pharmacy channel.

讓我們先來概覽一下我們 2025 年第三季的業績。我很高興地宣布，我們的淨銷售額達到 2,730 萬美元，年增 63%。第三季營收成長主要得益於本季新增 5,334 名患者，較去年同期成長 68%，以及我們不斷成長的用戶群透過藥局管道取得 iLet 的每月耗材。

In Q3, a low [30%] of our new patient starts were reimbursed through the pharmacy channel, which is significantly higher than the high-single-digit percentage we saw in Q3 of the prior year and increasing sequentially compared to the high 20% we saw in Q2 of this year.

第三季度，我們新患者的治療費用中只有 30% 透過藥房管道獲得報銷，這比上年第三季度的個位數百分比高出很多，並且比今年第二季度的 20% 以上百分比逐年增加。

As of the end of Q3, Beta Bionics has greater than 80% of insured lives in the US covered under formulary agreements with pharmacy benefit managers or PBMs, including all the major PBMs that operate in the US. However, patients covered under those formulary agreements do not yet benefit from the pharmacy channel until the health plans that partner with those PBMs adopt the iLet for reimbursement under their pharmacy benefit, which is why the over 80% of covered lives under PBM agreements differs from the low 30% of our new patient starts that actually benefited from accessing the iLet and its consumables through the pharmacy channel during the quarter.

截至第三季末，Beta Bionics 在美國擁有超過 80% 的投保人，這些投保人透過與藥品福利管理機構 (PBM) 的處方集協議獲得保障，其中包括在美國運營的所有主要 PBM。然而，根據這些處方集協議涵蓋的患者，只有在與這些藥品福利管理機構 (PBM) 合作的健康計劃在其藥品福利中採用 iLet 進行報銷後，才能從藥房管道受益。這就是為什麼 PBM 協議涵蓋的 80% 以上的人群與我們本季度透過藥房管道實際受益於 iLet 及其耗材的新患者中僅有 30% 的人群存在差異的原因。

Driving adoption of the iLet as a pharmacy benefit at the health plan level remains a core focus of ours, and that is why we share the percentage of new patients starts going through the pharmacy as the right KPI to use to measure our progress in that channel, not just the PBM-covered lives percentage, which does not account for pull through at the health plan level.

推動 iLet 作為健康計劃層面的藥房福利的普及仍然是我們的核心重點，因此我們認為透過藥房開始使用 iLet 的新患者百分比是衡量我們在該管道進展的正確 KPI，而不僅僅是 PBM 覆蓋人群的百分比，因為後者沒有考慮到健康計劃層面的推廣。

Shifting now to gross margin, our gross margin in the quarter was 55.5%, up 212 basis points compared to 53.4% in Q3 of 2024, and up 167 basis points sequentially relative to 53.8% in Q2 of this year.

現在來看毛利率，本季我們的毛利率為 55.5%，比 2024 年第三季的 53.4% 成長了 212 個基點，比今年第二季的 53.8% 環比成長了 167 個基點。

Last quarter, we guided towards sequential gross margin expansion in Q3 of this year relative to the prior quarter, citing benefits of increased scale and manufacturing volume leverage, greater contribution of high margin revenue from our growing pharmacy installed base, and continued cost discipline. We delivered in all those areas in Q3 and expect that each of those factors will continue to provide a tailwind to gross margin in Q4, as Stephen will discuss in more detail shortly.

上個季度，我們預計今年第三季度毛利率將比上個季度有所增長，理由是規模擴大和生產量槓桿作用增強、不斷增長的藥房裝機量帶來的高利潤收入貢獻更大，以及持續的成本控制。我們在第三季在所有這些領域都取得了成果，並預計這些因素將在第四季度繼續為毛利率帶來利好，Stephen稍後將對此進行更詳細的討論。

Looking ahead, I'm confident in the direction this business is headed in. The iLet's highly differentiated, fully adaptive, closed loop algorithm is producing phenomenal real-world outcomes, and those outcomes are resonating with users, caregivers, providers, and payers. We're expanding availability for the iLet in the pharmacy channel, enabling more people with diabetes to access insulin pump therapy with minimal to no upfront out-of-pocket costs.

展望未來，我對公司的發展方向充滿信心。iLet 高度差異化、完全自適應的閉環演算法正在產生驚人的實際效果，這些效果引起了用戶、護理人員、醫療服務提供者和支付方的共鳴。我們正在擴大 iLet 在藥房管道的供應範圍，使更多醣尿病患者能夠以極少甚至無需預付自付費用即可獲得胰島素幫浦治療。

The 20 new territories we onboarded toward the end of Q1 of this year have hit the ground running, and they're validating our strategy to remain disciplined and highly selective in our salesforce hiring as we look forward.

今年第一季末，我們新增的 20 個銷售區域迅速投入運營，這驗證了我們未來在銷售人員招募方面保持嚴謹和高度選擇性的策略是正確的。

With that, I'll hand the call over to Stephen to provide some additional color on our third-quarter performance and full year 2025 guidance and later wrap up the call with some important updates on our pipeline.

接下來，我將把電話交給 Stephen，讓他進一步介紹我們第三季的業績和 2025 年全年預期，並在電話會議的最後更新我們產品線的最新情況。

Stephen?

史蒂芬？

Thanks, Sean. Approximately 70% of our 5,334 new patients starts in Q3 came from people with diabetes that used multiple daily injections prior to starting the iLet, which is an important representation of how much the iLet is expanding the market for insulin pumps and addressing an unmet need.

謝謝你，肖恩。第三季新增的 5,334 名患者中，約有 70% 是糖尿病患者，他們在開始使用 iLet 之前每天需要多次注射胰島素。這充分錶明 iLet 正在擴大胰島素幫浦的市場，並滿足未被滿足的需求。

We believe the iLet is a game changer given its unique simplicity and ease of use, powered by the most advanced adaptive algorithm available. Given its simplicity, we're able to reach a broader group of patients and providers that were previously inaccessible to existing automated insulin delivery players, and we're seeing that in our results.

我們相信 iLet 將會改變遊戲規則，因為它具有獨特的簡潔性和易用性，並採用了最先進的自適應演算法。由於其簡便性，我們能夠接觸到更廣泛的患者和醫療服務提供者群體，而這些群體以前是現有自動化胰島素輸送設備無法觸及的，我們的結果也證明了這一點。

Turning to gross margin. The improvements we saw in our Q3 gross margin relative to the prior year and the prior quarter are driven by two primary factors. Number one, growth in the pharmacy installed base, which generates high margin recurring revenue and where we continue to see strong patient retention.

接下來我們來看毛利率。與去年同期和上一季相比，我們第三季毛利率的改善主要受兩個因素驅動。第一，藥局裝機量的成長，帶來了高利潤的經常性收入，而且我們持續看到強勁的病患留存率。

And number two, lower cost per unit from higher manufacturing volumes driven by growth and patient demand.

第二，成長和病患需求推動了生產量的增加，從而降低了單位成本。

Shifting to operating expenses, total operating expenses in the third quarter were $32.2 million, an increase of 62% compared to $19.9 million in the third quarter of 2024. The increase in sales and marketing expenses relative to the prior year is driven by expansion of our field sales team, which still stands at 63 sales territories exiting Q3.

轉而關注營運支出，第三季營運支出總額為 3,220 萬美元，比 2024 年第三季的 1,990 萬美元增加了 62%。與前一年相比，銷售和行銷費用的增加是由於我們的現場銷售團隊的擴張，截至第三季末，我們的銷售區域仍達到 63 個。

The increase in R&D expenses relative to the prior year is driven by the Mint and bihormonal programs. The increase in G&A expenses relative to the prior year is driven by new costs related to operating as a public company.

與前一年相比，研發費用的增加主要由 Mint 和雙激素計畫推動。與前一年相比，一般及行政費用的增加是由於作為一家上市公司運營所產生的新成本所致。

Let's discuss cash. As of September 30, 2025, we have approximately $274 million in cash, cash equivalents, and short- and long-term investments. We are sufficiently capitalized to fund all of our key initiatives and position to begin generating free cash flow well ahead of historical diabetes peers.

我們來談談現金吧。截至 2025 年 9 月 30 日，我們擁有約 2.74 億美元的現金、現金等價物以及短期和長期投資。我們擁有充足的資金來支持我們所有的關鍵舉措，並有能力在糖尿病領域領先以往的同行，開始產生自由現金流。

Turning to our updated full year 2025 guidance, we are raising guidance across the board. We project total revenue for the full year of 2025 will be greater than $96.5 million, up from our prior guidance of $88 million to $93 million. This means we project sales of at least $28.5 million in Q4 2025.

展望我們更新後的 2025 年全年業績預期，我們將全面上調業績預期。我們預計 2025 年全年總收入將超過 9,650 萬美元，高於我們先前預測的 8,800 萬美元至 9,300 萬美元。這意味著我們預計 2025 年第四季銷售額至少為 2,850 萬美元。

For the full year 2025, we now expect 27% to 29% of our new patient starts to be reimbursed through the pharmacy channel versus our prior guidance of 25% to 28%. This implies that we project our pharmacy mix as a percentage of new patients starts in Q4 to be similar to the mix we saw in Q3.

我們現在預計，到 2025 年全年，我們新增患者中將有 27% 至 29% 的患者透過藥局管道獲得報銷，而我們先前的預期是 25% 至 28%。這意味著我們預計第四季度新患者就診的藥房組合比例將與第三季度看到的組合相似。

I want to point out a couple of factors that could create variability to the upside or downside in our pharmacy mix of new patients starts in Q4. On one hand, we continue to drive more adoption of the iLet under the pharmacy benefit at the health plan level, which pushes pharmacy mix higher.

我想指出一些因素，這些因素可能會導致我們藥房第四季度新患者數量的增加或減少。一方面，我們繼續推動在健康計畫層面的藥房福利中更多地採用 iLet，從而提高藥房組合的佔比。

On the other hand, new patient starts in the DME channel tend to be strong in Q4 because many people have hit their out-of-pocket maximum and can receive their pump and supplies at no cost until year end.

另一方面，DME通路的新患者數量在第四季度往往比較強勁，因為許多人已經達到了自付費用上限，可以在年底前免費獲得幫浦和耗材。

Taking those dynamics together, we expect Q4 pharmacy mix as a percentage of new patients starts to be similar to Q3, but recognize there is potential for that mix to trend higher or lower based on those dynamics.

綜合考慮這些因素，我們預計第四季度藥房產品佔新患者的比例將與第三季度相似，但我們也意​​識到，根據這些因素，該比例有可能上升或下降。

Moving on to gross margin. We are raising our outlook to 54% to 55% gross margin for the full year 2025 versus our prior guidance of 52% to 55%. This means we project Q4 gross margin to be in line with or improve slightly relative to Q3. We are increasing guidance at the low end and midpoint of the range for a couple of reasons.

接下來分析毛利率。我們將 2025 年全年毛利率預期上調至 54% 至 55%，而先前的預期為 52% 至 55%。這意味著我們預計第四季毛利率將與第三季持平或略有增加。我們上調了預期價格區間下限和中點的指引，原因有二。

Number one, embedded in our revenue guidance raise and pharmacy mix guidance raise is a raise in our expectations for new patient starts, and that increased scale should generate a lower per unit cost through manufacturing volume leverage.

第一，我們提高了收入預期和藥房組合預期，同時也提高了對新患者數量的預期，而規模的擴大應該能夠透過生產量槓桿作用降低單位成本。

And number two, we expect to benefit from our growing pharmacy installed base where the large number of new pharmacy users year to date combined with the strong retention of those users produces high-margin recurring revenue in Q4 and beyond.

第二，我們預計將受益於不斷增長的藥房安裝基礎，今年迄今新增的大量藥房用戶，加上這些用戶的強勁留存率，將在第四季度及以後產生高利潤的經常性收入。

We continue to contemplate the impact of existing and potential tariffs on our full year gross margin guidance. We are aware of recent initiatives focused on re-evaluating the application of tariffs in our industry and do not have a reason at this time to believe that duty-free exemptions from custom components of the iLet and its consumables are in any jeopardy.

我們將繼續評估現有和潛在關稅對全年毛利率預期的影響。我們注意到最近一些旨在重新評估本行業關稅適用性的舉措，目前我們沒有理由相信iLet及其耗材的客製化組件的免稅待遇會受到任何威脅。

With that, I'll hand the call back to Sean to discuss updates in our innovation pipeline. Sean?

接下來，我將把電話轉回給肖恩，討論我們創新專案的最新進展。肖恩？

Thanks, Stephen. As I've stated before, our goal with our pipeline programs is to disrupt the industry and disrupt ourselves.

謝謝你，史蒂芬。正如我之前所說，我們推出這些計畫的目標是顛覆整個產業，也顛覆我們自己。

Let's start with an update on Mint, our patch pump and development. We've spoken at length in the past about the key advantages of Mint's two-piece design architecture, where we believe we've chosen a design that creates an advantage user experience relative to other patch pumps currently on the market and in development.

讓我們先來了解一下 Mint 的最新進展，這是我們的修補程式和開發情況。我們過去曾詳細討論過 Mint 兩件式設計架構的主要優勢，我們相信我們選擇的設計能夠創造優於目前市場上和正在開發中的其他貼片泵的用戶體驗。

Our design choices spanning from a patch change experience that doesn't require phone interaction to eliminating the need for recharging, and to enabling firmware over the air updates are all in service of user experience.

從無需手機互動即可完成補丁更換，到消除充電需求，再到啟用韌體空中更新，我們的所有設計選擇都是為了提升用戶體驗。

Add those advantages to our industry-leading algorithm which has been shown to produce excellent clinical outcomes independent of user engagement, and we believe that Mint will be a true game changer when it commercializes. In Q3, we continue to execute according to plan on our Mint timelines and remain highly confident in our ability to gain 510(k) clearance for the product as well as manufactured at scale.

將這些優勢與我們領先業界的演算法相結合，該演算法已被證明能夠獨立於用戶參與產生出色的臨床結果，我們相信 Mint 在商業化後將真正改變遊戲規則。第三季度，我們繼續按計劃推進 Mint 專案的進度，並對我們獲得產品 510(k) 許可以及大規模生產的能力充滿信心。

Our goal remains to commercialize Mint with an unconstrained commercial launch by the end of 2027, meaning we expect to be able to fully support demand for the product by that time.

我們的目標仍然是在 2027 年底前實現 Mint 的商業化，不受任何限制地進行商業推廣，這意味著我們預計到那時將能夠完全滿足對該產品的需求。

Shifting to our bihormonal pump program, in September, we completed our pharmacokinetic, pharmacodynamic, or PK/PD bridging trial for our glucagon asset. Full results from that trial are in line with our expectations, and we believe such results are supportive of the continued development of our glucagon asset for use in our bihormonal system and development.

9 月份，我們完成了雙激素幫浦計畫的藥物動力學、藥效學或 PK/PD 橋接試驗，用於我們的胰高血糖素資產。該試驗的最終結果符合我們的預期，我們相信這些結果支持我們繼續開發胰高血糖素資產，用於我們的雙激素系統和開發。

In Q4 of this year, we expect to initiate a feasibility trial of our bihormonal system to test any humans for the first time with our glucagon asset before progressing the asset to any larger scale studies.

今年第四季度，我們預計將啟動雙激素系統的可行性試驗，首次在人體上測試我們的胰高血糖素資產，然後再將資產推進到任何更大規模的研究。

As a reminder, the PK/PD study was the first in human trial for our glucagon asset, but the bihormonal system also includes our bihormonal pump and algorithm for insulin and glucagon dosing. And we're yet to test that system using our glucagon asset in humans such that we believe the best strategy is to run at least one hormonal system feasibility trial before progressing to pivotal trials.

提醒一下，PK/PD 研究是我們升糖素資產的首次人體試驗，但雙激素系統還包括我們的雙激素幫浦和胰島素和升糖素劑量演算法。我們尚未在人體中使用我們的胰高血糖素資產來測試該系統，因此我們認為最好的策略是在進行關鍵性試驗之前至少進行一次荷爾蒙系統可行性試驗。

There is no change to our expectations that we'll conduct concurrent pivotal trials to fulfill the requirements for a 505(b)(2) NDA with a chronic drug indication for glucagon and the ACE and iAGC 510(k)s for the pump and algorithm, respectively.

我們仍期望進行同步關鍵性試驗，以滿足胰高血糖素慢性藥物適應症的 505(b)(2) NDA 要求，以及泵浦和演算法的 ACE 和 iAGC 510(k) 要求。

We continue to be extremely excited by the bihormonal system's ability to transform clinical outcomes for people with diabetes, but more importantly, the ability to transform the way people experience their diabetes and shift their mindset from diabetes being a disease that they manage to simply a disease that they have.

我們仍然對雙激素系統能夠改變糖尿病患者的臨床結果的能力感到非常興奮，但更重要的是，它能夠改變人們對糖尿病的體驗方式，並將他們的思維方式從糖尿病視為一種需要控制的疾病轉變為一種他們患有的疾病。

To highlight another recent win in our pipeline, on September 29, we received a special 510(k) clearance for certain feature updates for the iLet. These updates focused on improving the usability of the pump. We introduced an improved workflow for the cartridge change process to make it more seamless for the user and eliminated redundant low glucose alerts to ensure our users are focusing on the alerts that matter most while reducing alert fatigue.

為了強調我們近期取得的另一場勝利，9 月 29 日，我們獲得了 iLet 某些功能更新的特殊 510(k) 許可。這些更新主要集中在提高泵浦的易用性。我們引入了改進的墨盒更換流程，使用戶操作更加順暢，並取消了冗餘的低血糖警報，以確保用戶專注於最重要的警報，同時減少警報疲勞。

These updates are illustrative of both the intent we have in listening to feedback from our users, as well as the speed with which we operate in an effort to ensure our users' needs are consistently met every day.

這些更新既體現了我們認真聽取使用者回饋的意願，也反映了我們為確保使用者需求每天都能持續滿足而採取的快速行動。

There's one more update that I'd like to discuss on the regulatory front. In late June, the FDA issued a Form 483 following an inspection. The Form 483 is primarily related to our customer complaint handling system and our criteria for reporting complaints to the FDA, which are ultimately reflected in the FDA's manufacturer and user facility device experience database, also known as the [mod] database.

關於監理方面，我還有一項更新想跟大家討論。6 月下旬，FDA 在一次檢查後簽發了 483 表格。483 表格主要與我們的客戶投訴處理系統以及我們向 FDA 報告投訴的標準有關，這些最終反映在 FDA 的製造商和使用者設施設備體驗資料庫中，也稱為 [mod] 資料庫。

The results of the FDA's inspection is not unusual in our industry, as numerous precedents the agency has set for our peers at similar stages would suggest. We believe that in those instances, Beta Bionics and our peers likely developed similar definitions for what constitutes a reportable complaint prior to the FDA's feedback, and each company has successfully taken the steps required to align reporting with the FDA's standards. We are no different, and our remediation efforts to the Form 483 are straightforward and well underway.

FDA 的檢查結果在我們的行業中並不罕見，該機構為處於類似階段的同行樹立的許多先例就表明了這一點。我們認為，在這些情況下，Beta Bionics 和我們的同行可能在 FDA 反饋之前就對構成可報告投訴的內容制定了類似的定義，並且每家公司都成功地採取了必要的措施，使報告符合 FDA 的標準。我們也不例外，我們對 483 表格的補救措施簡單明了，目前正在順利進行中。

Regarding the change to the criteria for reporting complaints to the FDA, we revised our definition of what complaints are reportable to better align with the broader industry standards. Our revised standard operating procedure for reportable complaints took effect in late July, which resulted in the notable increase in reportable complaints in August and September.

關於向 FDA 報告投訴的標準變更，我們修改了哪些投訴需要報告的定義，以更好地與更廣泛的行業標準保持一致。我們修訂後的可報告投訴標準作業程序於 7 月下旬生效，導致 8 月和 9 月可報告投訴數量顯著增加。

To cite some examples of how our definition of reportable complaints has changed, prior to the 483, we were not reporting complaints such as the device's screen cracking or a hypo or hypoglycemic event that did not require medical intervention.

舉例說明我們對可通報投訴的定義是如何改變的，在 483 條款之前，我們不會報告諸如設備螢幕破裂或低血糖或低血糖事件等不需要醫療幹預的投訴。

We now report these types of complaints to the FDA, given they could result in an adverse event if ignored. I want to make something abundantly clear. While the number of complaints we have reported to the FDA increased, most notably in August and September after the new system went live, this is not the result of a change to the underlying complaint or adverse event rate relative to our installed base.

鑑於忽視此類投訴可能會導致不良事件，我們現在會將此類投訴報告給 FDA。我想把一件事說得非常清楚。雖然我們向 FDA 報告的投訴數量有所增加，尤其是在新系統上線後的 8 月和 9 月，但這並不是由於我們已安裝的系統的基本投訴或不良事件發生率發生了變化。

In terms of what to expect going forward, since we received the Form 483 in June, we've submitted monthly progress reports to the agency. We're confident that our new complaint handling system and reporting system meets or exceeds the expectations laid out by the agency in their Form 483 observations.

至於未來的預期，自從我們在 6 月收到 483 表格以來，我們已經向該機構提交了每月進度報告。我們有信心，我們新的投訴處理系統和報告系統能夠達到或超過該機構在 483 表格觀察結果中提出的預期。

As part of this process, we will be applying the new reporting criteria to all historical complaints we have received since the iLet launched. That remedial filing process started very recently.

作為此過程的一部分，我們將把新的報告標準應用於自 iLet 推出以來我們收到的所有歷史投訴。這個補救性備案程序是最近才開始的。

As such, we expect to see the number of mod entries relative to our installed base increase considerably from October to November and remain elevated until we have completed the remediation process, as both current and historical complaints will layer on top of each other. We expect to complete the remediation process by the end of Q2 2026, at which time the number of mod entries relative to our install base will fall as historical reports are no longer being submitted.

因此，我們預計從 10 月到 11 月，相對於我們的安裝基礎，mod 條目的數量將大幅增加，並且在我們完成補救過程之前將保持高位，因為當前和歷史投訴都會相互疊加。我們預計將在 2026 年第二季末完成修復過程，屆時，由於不再提交歷史報告，相對於我們的安裝基礎，mod 條目的數量將會下降。

Shifting the topic of type 2 diabetes. In Q3, we continue to see some healthcare providers prescribed islet to their type 2 diabetes patients off label. We estimate that over 25% of our new patients starts in Q3 were from type 2, which is consistent with the prior quarter. While we're not committing to a specific timeline, we remain eager to pursue the type 2 diabetes label through the FDA.

轉移話題，談第2型糖尿病。第三季度，我們繼續看到一些醫療保健提供者給 2 型糖尿病患者開胰島細胞的處方，但這是超適應症用藥。我們估計，第三季新入院患者中超過 25% 為第 2 型糖尿病患者，這與上一季的情況一致。雖然我們沒有承諾具體的時間表，但我們仍然渴望透過 FDA 申請 2 型糖尿病標籤。

To conclude the prepared remarks portion of today's call, I want to highlight the key points that we hope you take away from our discussion. Number one, the iLet's differentiation is resonating wider and deeper in the market.

在今天電話會議的準備好的發言部分結束之際，我想強調我們希望大家從我們的討論中記住的幾個要點。第一，iLet 的差異化優勢正在市場上引起更廣泛、更深入的共鳴。

Number two, our commercial strategy is working and we're continuing to execute relentlessly toward the goal of making iLet the new standard of care.

第二，我們的商業策略正在奏效，我們將繼續不懈努力，朝著使 iLet 成為新的護理標準這一目標邁進。

Lastly, we're aiming to build the most innovative pipeline in the industry with the goal of disrupting the industry and ourselves, and we continue to make progress on each key pipeline initiative every day. This is a business that we believe is set up for sustainable success of the near, medium, and long-term, and we're excited to continue sharing updates with you all as we continue to execute.

最後，我們的目標是打造業界最具創新性的研發管線，以顛覆整個產業和我們自身，我們每天都在各個關鍵研發管線專案上不斷取得進展。我們相信，這項業務已經為近期、中期和長期的可持續成功奠定了基礎，我們很高興能夠繼續與大家分享最新進展，並繼續推進各項工作。

With that, thank you all for tuning in, and we'll now open the call for Q&A.

感謝大家的收看，現在我們進入問答環節。

(Operator Instructions) Mike Kratky, Leerink Partners.

（操作員說明）Mike Kratky，Leerink Partners。

Hi, everyone, thanks for taking our questions. The fact that you're creeping up on $100 million in revenue for the year and at a much higher rate of pharmacy mix than we've been expecting is super impressive. So congrats on the ongoing execution.

大家好，感謝各位回答我們的問題。你們今年的收入即將達到 1 億美元，而且藥局業務佔比遠高於我們的預期，這真是令人印象深刻。恭喜你們的執行工作進展順利。

Just at that point, can you share some additional color on what's driving that momentum you're seeing, what factors really seem to be contributing to that demand? And can you talk about the cadence of new starts throughout the third quarter, specifically that's shaping your assumptions, on the fourth quarter?

在此，您能否進一步闡述您所看到的這種成長動能背後的驅動因素，哪些因素真正促成了這種需求？您能否談談第三季新專案的啟動節奏，特別是這如何影響您對第四季的預期？

Yeah, Mike, first of all, thanks a lot for that. Appreciate it. In terms of what's driving the quarter, I mean, I frankly -- I don't think it's anything different than what's been driving our success all along. We do see the iLet as a new category of device and fundamentally that takes a bit of time, right?

是的，麥克，首先非常感謝你。謝謝。至於推動本季業績成長的因素，坦白說，我認為它與我們一直以來取得成功的因素並沒有什麼不同。我們認為 iLet 是一種新型設備，而這從根本上來說需要一些時間，對吧？

We're not launching just another insulin pump here; we're launching an insulin pump that you have to think a little differently about. And that takes time and necessarily we're going to see increased adoption as the world gets it more and more over time, and I think we just saw that continuing, but I don't think there's any particular initiative that I could point to uniquely in Q3 that really impacted the quarter.

我們推出的不只是另一款胰島素幫浦；我們推出的是一款需要你用不同方式思考的胰島素幫浦。這需要時間，隨著世界逐漸接受它，我們必然會看到採用率不斷提高，我認為我們剛剛也看到了這種趨勢的持續，但我認為在第三季度並沒有什麼特別的舉措真正對該季度產生了影響。

Stephen, can you comment further?

史蒂芬，你還能再補充一些內容嗎？

Yeah, cadence and demand, I'll just address that briefly. It was generally consistent across the entire quarter, so nothing really to read into in terms of timing of demand and where it was relative to the upcoming quarter.

是的，節奏和需求，我簡單談談。整個季度情況基本一致，因此從需求的時間安排以及與下一個季度的相對位置來看，沒有什麼可解讀的。

Understood. And maybe just one quick follow-up, in terms of things that are out of your control, how does the government shutdown impact your assumptions on timing for the Mint launch, if at all?

明白了。最後還有一個小問題，就您無法控制的事情而言，政府停擺會對您對 Mint 上線時間的預期產生什麼影響（如果有的話）？

I would say it doesn't currently have an impact on our expectations for timing. We reiterated those earlier in the call.

我認為目前這不會影響我們對時間安排的預期。我們在通話早些時候重申了這些內容。

Yeah, I'll leave it at that.

好的，我就說到這裡吧。

Understood. Thanks very much.

明白了。非常感謝。

David Roman, Goldman Sachs.

大衛羅曼，高盛集團。

Thank you and good afternoon, everyone. I appreciate you taking the questions here. Maybe I'll just start with a further question on kind of what you're seeing in the underlying market dynamics. You talked about the 70% of patients coming from MDI converts. Can you maybe give us a flavor on the remaining 30% of the patients, whether that's coming from conversions from patients who are coming up for renewal?

謝謝大家，下午好。感謝您接受大家的提問。或許我可以先問一個關於您觀察到的潛在市場動態的問題。你提到70%的患者都是從MDI（定量吸入器）轉來的。您能否簡單介紹一下剩餘 30% 的病患狀況，例如他們是否來自即將續保的病患？

It looks to be a big bolus of renewal patients coming to market. Is that conversions from different pump therapy? Maybe just help us understand the balance of the growth drivers there and how you see that unfolding through the rest of '25 and in '26.

看來將有大量續保患者湧入市場。這是不同幫浦治療方案之間的轉換嗎？或許您可以幫我們了解當地成長驅動因素的平衡情況，以及您認為這種情況在 2025 年剩餘時間和 2026 年將如何發展。

Yeah, thanks, David. This is Stephen here. Then in terms of the remaining 30% that are coming to us from competitive pump systems, they're coming roughly one-third, one-third, one-third from the three primary competitors. And in terms of the outlook in the future, there's nothing that -- look, that bifurcation of our demand coming from -- 70% coming from injections and the other 30% coming from competitive pumps, that's been pretty consistent over the last four to eight quarters.

謝謝你，大衛。這位是史蒂芬。至於剩下的 30% 來自競爭泵浦系統的份額，它們大約三分之一、三分之一、三分之一來自三大主要競爭對手。至於未來的前景，沒有什麼——你看，我們的需求分成了兩部分——70% 來自註入，另外 30% 來自競爭性加油站，這種情況在過去四到八個季度中一直相當穩定。

And there's nothing that we see in our business that would imply that the future will look any differently. I would say there's still like -- the market for insulin pumps in both type 1 and type 2 is still very under penetrated. I want you to remind you of those percentages and so the large opportunity that still exists for a company like ours with a new and differentiated system remains an MDI, and I expect most of our demand will continue to come from there.

從我們目前的業務狀況來看，沒有任何跡象表明未來會有任何不同。我認為，無論是第 1 型糖尿病還是第 2 型糖尿病，胰島素幫浦的市場滲透率仍然非常低。我希望你記住這些百分比，因此，對於像我們這樣擁有全新差異化系統的公司來說，仍然存在著巨大的機會，那就是 MDI，而且我預計我們的大部分需求將繼續來自那裡。

That's very helpful and I appreciate you're reiterating the timelines around the mid, full commercialization by the end of 2027, but can you maybe just remind us of the different steps that need to take place between now and then? For example, have you finished human factor testing, and what types of updates will you be able to provide us along the way?

這很有幫助，我很感謝你重申了中期全面商業化的時間表，目標是在 2027 年底實現，但你能否提醒我們一下從現在到那時需要採取哪些不同的步驟？例如，你們是否已經完成了人因工程測試？在此過程中，你們能夠提供我們哪些類型的更新資訊？

Yeah, I don't think we're going to provide any additional information on where we are at the moment. I mean, we would reiterate that generically, the three main steps that we need to look for here, our 510(k) clearance followed by manufacturing readiness followed by launch, we talked about those in the past.

是的，我認為我們不會提供任何關於我們目前處境的更多資訊。我的意思是，我們重申一下，總的來說，我們需要關注的三個主要步驟是：510(k) 許可、生產準備和產品上市，我們過去已經討論過這些。

But I don't want to get into the details exactly where our internal program is, less people read more or less in them than they deserve. So for the moment, we'll reiterate our timelines and we reserve the right, of course, at all times to update you as we know more.

但我不想透露我們內部專案的具體細節，因為很少有人會太多或過少閱讀其中的內容。所以目前，我們將重申我們的時間表，當然，我們始終保留在了解更多資訊後及時更新的權利。

Great, thank you very much.

太好了，非常感謝。

Matt O'Brien, Piper Sandler.

馬特·奧布萊恩，派珀·桑德勒。

I appreciate the questions. Maybe just starting with those 20 new territories that you added in Q1, maybe if you can just tease out the impact that those 20 territories are having here in Q3 because you don't typically see such a meaningful step-up here in the third quarter versus Q4 based on seasonality? So maybe talk about how those reps are ramping.

感謝大家的提問。或許可以先從第一季新增的 20 個地區入手，看看這 20 個地區在第三季產生了哪些影響，因為通常情況下，由於季節性因素，第三季與第四季相比不會出現如此顯著的成長？所以或許可以談談這些重複次數是如何逐漸增加的。

And then kind of what's left for that group for that cohort, as we think about maybe the next 18 months?

那麼，展望未來 18 個月，對這群人、這群人來說，還剩下什麼呢？

Yeah. All right, so the territory, the new territories that we added at the start of the year are absolutely growing in their maturity and increasing in productivity, but the entire sales force on balance also is. So if you looked at even just the quarter-over-quarter growth in new patients starts from Q2 to Q3, we saw an 8% uptake.

是的。好的，所以年初新增的這些區域，其成熟度和生產力都在不斷提高，但總體而言，整個銷售團隊也是如此。即使只看第二季到第三季新患者數量的季度環比增長，我們也看到了 8% 的增長。

And yes, that is driven in large part by the new 20 new territories that we had in the start of the year, but the iLet is still new to almost every territory nationwide and so we're continuing to see an uptake in new store sales, same-store sales across the entire country.

是的，這在很大程度上得益於年初新增的 20 個地區，但 iLet 對全國幾乎所有地區來說仍然是全新的，因此我們繼續看到全國各地的新店銷售額和同店銷售額都在增長。

Okay, and then maybe talk a little bit -- I wanted to ask a little bit more about Mint, but just maybe talk a little bit more about the 483 because that's a little bit of new information, and how serious that is, your remediation efforts? It sounds like you're kind of on track already so maybe just try to frame up the 483 for us, not that they're ever great to see, not that you take them for granted.

好的，然後也許可以稍微聊聊——我想多問一些關於Mint的問題，但也許可以多談談483，因為這是一個新信息，以及它的嚴重性，你們的補救措施？聽起來你已經基本上走上正軌了，所以也許可以試著為我們描繪一下 483 號公路，雖然它們並不怎麼令人愉快，但你也並非認為它們是理所當然的。

But just how this one falls in terms of seriousness and then your ability to respond quickly? Thank you.

但這件事的嚴重程度如何？你又能否迅速做出反應？謝謝。

Yeah, great question, Matt. I mean, it's tough to put a qualifier on something like that. I mean, obviously the FDA issues -- 483 is when they find something to be important, but I think with the 483, as long as you're aggressive with dealing with the problem, you don't have a big problem, and we've certainly been that.

是啊，問得好，馬特。我的意思是，很難給這樣的事情加上限定條件。我的意思是，很明顯，FDA 的問題——483 條款是他們發現某些事情很重要的時候才會提出的，但我認為對於 483 條款，只要你積極主動地處理問題，就不會有大問題，而我們當然一直都是這樣做的。

We're very far along in our remediation efforts, new systems are fully in place at this time, and what we're seeing now, as we stated on the prepared remarks is just the implementation of those systems and sort of remediating past complaints. But the new systems are in place at this time and no, we don't foresee any ongoing challenges with this at all.

我們的補救工作已經取得了很大進展，新的系統目前已經全面到位，正如我們在準備好的發言稿中所說，我們現在看到的只是這些系統的實施以及對過去投訴的補救。但目前新系統已經到位，我們預計不會再有任何挑戰。

Stephen, you got anything to add to that?

史蒂芬，你還有什麼要補充的嗎？

Sure, yeah, I think -- look, the FDA interpret -- or the interpretation of the rules for what's considered a reportable complaint and what's considered a non-reportable complaint actually leaves a lot of room for interpretation, and so we were interpreting before the 483 observation. We were interpreting the rules a particular way that we had a lot of confidence in and we're not apologetic about.

當然，是的，我認為——你看，FDA 對“可報告投訴”和“不可報告投訴”的規則解釋實際上留下了很多解釋的空間，所以我們在 483 號意見之前就是這樣解釋的。我們當時對規則的解讀方式非常有信心，我們對此並不感到抱歉。

However, when the FDA did their observation, they disagreed with our interpretation, which is totally fine. They asked us to remediate our -- and use the new definition, and we of course complied and now, to us this is a very benign issue as long as we actually do what we say we're going to do.

然而，當 FDA 進行觀察時，他們不同意我們的解釋，這完全沒問題。他們要求我們改正——並使用新的定義，我們當然照做了，現在，對我們來說，只要我們言出必行，這就是一個非常良性的問題。

And so we're bringing it to your attention because we feel it's important to be transparent. There may be some misinformation out there about why we've seen an uptake in reportable complaints in the mod database. We don't see it as an issue at all, and it's kind of on brand for us to just answer the mail and so hence why we brought it up today.

因此，我們特此提請您注意，因為我們認為保持透明非常重要。關於為什麼我們在模組資料庫中看到可報告的投訴數量增加，可能存在一些錯誤訊息。我們完全不認為這是一個問題，而且回覆郵件也符合我們的一貫作風，所以我們今天才提出這個問題。

Understood. Thanks so much.

明白了。非常感謝。

Travis Steed, Bank of America Securities.

特拉維斯·斯蒂德，美國銀行證券。

Hi, this is Stephanie Piazzolla on for Travis. Thanks for taking the question and congrats on a good quarter.

大家好，我是Stephanie Piazzolla，替Travis為您報道。感謝您回答這個問題，並祝賀您本季業績出色。

Maybe just wanted to follow-up again on the increased complaints being reported, maybe you can just elaborate more on the real-world performance and feedback and retention that you're seeing despite some of the complaints received?

或許您只是想再次跟進一下最近收到的投訴增加的情況，您能否詳細說明一下儘管收到了一些投訴，但您在實際工作中看到的表現、反饋和客戶留存情況？

And if you could clarify, it sounds like you've made good progress on the remediation already but some things will continue through Q2 of next year if I heard that right, so maybe you can just clarify what's going to be outstanding through them. Thanks.

如果您能澄清一下，聽起來您在補救工作方面已經取得了不錯的進展，但如果我理解正確的話，有些事情將持續到明年第二季度，所以也許您可以澄清一下到那時還有哪些事情尚未完成。謝謝。

Yeah, first of all, I wouldn't read anything into the word complaint in this case. The insulin pump industry is -- if you look at the complaint rates that all insulin pump companies receive, it's somewhat shocking at some level. And the primary reason for that is that definition that Stephen alluded to earlier where really anything -- anybody calls in with a problem with your product or an experience issue and it gets reflected as a complaint, which is fine.

首先，我認為在這種情況下，「抱怨」這個詞並沒有什麼特別的意思。胰島素幫浦產業的情況是——如果你看一下所有胰島素幫浦公司收到的投訴率，在某種程度上會令人震驚。主要原因在於 Stephen 之前提到的定義，即任何人打電話反映產品問題或體驗問題，都會被反映為投訴，這也沒關係。

Those are the rules. But I don't want anybody to hear, and I don't believe it's true that there's any complaint with the product that -- I don't know the right words here. Anyway, I wouldn't read too much into it. Second half of that question is --?

這就是規則。但我不想讓任何人聽到，而且我也不相信產品有任何投訴——我不知道該怎麼說。總之，我覺得沒必要過度解讀。問題的後半部是——？

I think -- I don't know, I think the kind of answers, Stephanie, was there a part that we missed?

我覺得──我不知道，我覺得史蒂芬妮，你給的答案是不是我們漏掉了什麼？

Yeah, I forgot the second half for her question.

是的，我忘了回答她問題的後半部。

It was just that you mentioned you made good progress on the remediation effort, but something to continue through next year.

剛才您提到，補救工作取得了良好進展，但還需要在明年繼續進行。

So yeah, you want details on that, absolutely. So what it is specifically, and I think we said this, but I'll give a little more clarity. When over time we received calls, right, everybody receives calls and you have to decide whether or not those get reflected as reportable complaints to the agency.

是的，你當然想知道細節。那麼具體是什麼呢？我想我們之前已經說過，但我再解釋得更清楚一些。隨著時間的推移，我們會接到一些電話，對吧？每個人都會接到電話，你必須決定這些電話是否應該作為需要向機構報告的投訴。

So what we're doing at this point is we're going back through all of those calls we've received since the dawn of time and reporting the ones that now qualify under the new definition as reportable events that did not prior. Does that make more sense?

所以，我們現在正在做的，就是回顧自古以來我們接到的所有電話，並將那些現在符合新定義、以前不符合報告標準的事件報告出來。這樣解釋得通嗎？

Yes, got it, thank you.

是的，明白了，謝謝。

And we'll be done with that process by Q2 next year.

我們將在明年第二季完成這個過程。

Okay, understood.

好的，明白了。

Again, the systems are now in place. Everything is working as it should at this point. We just have to go back and do all that catch-up work, that's all.

再次強調，各項系統現已到位。目前一切運作正常。我們只需要回去把所有落下的工作都做完，僅此而已。

Okay, got it.

好的，明白了。

And then you talked about some of the positive growth drivers that you have this year and are going to continue into Q4. Maybe just thinking a little bit ahead to next year, how we can think about some of those continuing, and then any headwinds that we should keep in mind for next year as well?

然後您談到了今年的一些積極成長動力，這些動力將延續到第四季。或許我們可以稍微展望一下明年，想想如何讓其中一些事情繼續下去，以及明年我們應該注意哪些不利因素？

Thank you.

謝謝。

Yeah, I'll start with that one and then Stephen can add anything that he may want to. The primary growth driver that I listed was obviously additional understanding what iLet is. Again, I think there's -- when you look at data on adoption from healthcare providers, it really takes quite a number of years, in fact.

好的，我先從這個開始，然後史蒂芬可以再添加他想添加的任何內容。我列出的主要成長驅動因素顯然是對 iLet 的進一步了解。再次強調，我認為——當你查看醫療保健提供者的採用數據時，你會發現這實際上需要相當長的時間。

So I think that we expect that that tailwind to continue over time as people start to understand iLet better as we develop more and more of our own real-world evidence and get that evidence out there, showing the world how well iLet really is working in a in a real-world setting. So those continue, obviously.

因此，我認為隨著我們不斷累積更多現實世界的證據並將這些證據公之於眾，向世界展示 iLet 在現實世界中的實際效果，人們會逐漸更好地了解 iLet，我們預計這種順風勢會持續下去。所以，這些情況顯然還會持續下去。

The other tailwind that I'll mention is obviously pharmacy adoption. There's a lot of reasons that pharmacy adoption is better for the business. It makes it easier to adopt dial it, easier to script dial it. Obviously with the expansion of that, that's certainly going to be a tailwind, and we hope that the expansion of pharmacy adoption itself continues more in the next year as well.

另一個值得一提的利多因素顯然是藥局的普及。藥局採用這種模式對企業有許多好處。這樣比較容易採用撥號方式，也比較容易編寫撥號腳本。顯然，隨著藥局的擴張，這肯定會是一個有利因素，我們也希望明年藥局的普及程度能繼續提高。

And this year -- and by the way, thanks for the compliments, Stephanie, on the results. We're definitely happy with them.

今年——順便說一句，謝謝你對結果的讚揚，史蒂芬妮。我們對他們非常滿意。

The uptake that we've seen in pharmacy this particular year, meaning now in the low 30s percentage of our new patients starts, it's way exceeded even our internal expectations and what it's really doing for next year's financials that that's great is that we're retaining those patients at a very high level.

今年我們在藥局看到的接受度顯著提高，這意味著現在我們新患者的接受度達到了 30% 左右，這遠遠超出了我們內部的預期，這對明年的財務狀況來說非常棒，因為我們以非常高的水平留住了這些患者。

And because of that, it's high margin recurring revenue now that we have in this pharmacy installed base, which is the design of the whole program and that's the intention of the whole program to move to a subscription like revenue stream and you're going to see that in our financials and you've already been seeing that and even like the gross margin profile that we now have again have this high margin revenue that we've generated from our growing pharmacy installed base.

正因如此，我們現在在這個藥局安裝基礎中擁有了高利潤的經常性收入，這正是整個計劃的設計初衷，也是整個計劃的目標，即轉向類似訂閱的收入流。您將在我們的財務報表中看到這一點，而且您已經看到了這一點，甚至從我們現在的毛利率來看，我們再次擁有了從不斷增長的藥房安裝基礎中產生的高利潤收入。

Michael Polark, Wolfe Research.

邁克爾·波拉克，沃爾夫研究中心。

First topic for me was the 510(k) clearances you mentioned, different cartridge change process and elimination of redundant low glucose alerts. I guess I'd just be curious that the cartridge change process, what improved, how was it before? How is it now and what kind of was root cause, if you will, of too many low glucose alerts? Is that a software fix or another change?

我首先要討論的是您提到的 510(k) 許可、不同的墨盒更換流程以及消除冗餘的低血糖警報。我只是好奇墨盒更換過程，有哪些改進，以前是什麼樣的？現在情況如何？造成低血糖警報過多的根本原因是什麼？這是軟體修復還是其他改動？

Yeah, so on the first part the exchange process, these are really just subtleties in the process, different screens and whatnot, user experience stuff, they're not huge, but we think meaningful. On the low glucose alert, so I want to make really make sure that one's really clear, with a system like an insulin pump, you can get for example an urgent low, a low, a very low, there's all different kinds of alerts and they can stack on top of one another and require you to clear each one individually and what have you.

是的，所以在交換流程的第一部分，這些實際上只是流程中的一些細微之處，不同的螢幕等等，使用者體驗方面的東西，它們並不大，但我們認為很有意義。關於低血糖警報，我想確保這一點非常清楚，使用像胰島素幫浦這樣的系統，例如，你會收到緊急低血糖、低血糖、極低血糖等各種警報，它們會相互疊加，需要你逐一清除等等。

Or you can look at it and take the most severe of those alerts and only deal with that one, for example. So it's sort of related to that. It's just like you really have to clear four alerts at all in effect until you're low that seems pointless, right? Does that make sense?

或者，您可以查看這些警報，然後只處理其中最嚴重的警報，例如。所以這跟那件事有點關係。就好像你必須清除所有四個生效的警報才能恢復正常，這似乎毫無意義，對吧？這樣說得通嗎？

Yeah, understood.

嗯，明白了。

The other one is just maybe kind of a look into '26 as well or a reminder on what's a good way to think about sales force expansion as you roll into next year? Any soft circle for a number of territories that you would hope to add?

另一份報告或許是對 2026 年的展望，或是提醒大家在邁入明年之際，如何能更好地考慮銷售團隊擴張？您希望增加哪些地區的軟性圈選？

Yeah, of course, good question, Mike. Yes, of course, we have our internal expectation of how many new sales territories we're going to expand and win next year, but I'm not going to talk about a forecast for 2026 that gives any indication as to what our revenue is going to look like. So unfortunately, I'm not going to share that number.

當然，問得好，麥克。當然，我們內部對明年要拓展和贏得多少新的銷售區域有預期，但我不會談論 2026 年的預測，因為這會暗示我們的收入會是什麼樣子。所以很遺憾，我不能透露這個數字。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Great, thanks for taking the questions. Congrats on a really solid quarter. Just a curiosity question versus my model and I could be unique in how I modeled it this quarter, but it feels like the bigger portion of your performance, you have performed on both my DME and PBM expectations. A bigger portion for me was related to DME.

太好了，謝謝你回答這些問題。恭喜你們本季業績非常出色。只是出於好奇，我想問關於我的模型的問題。我這季度的建模方式可能比較獨特，但感覺你們的大部分業績都達到了我對DME和PBM的預期。對我來說，更大一部分原因與糖尿病性肌痛有關。

Was this just a modeling discrepancy on my side or was DME maybe a little bit stronger than you anticipated? Any specifics on maybe where the pumps were replaced with geographies maybe didn't have health plans set up, or anything to kind of call out that maybe drove that DME being a little stronger than my expectations?

這只是我這邊的模型偏差，還是DME的強度可能比你預期的還要強？有沒有具體說明哪些地區的輸液幫浦被更換，而這些地區可能沒有醫療保險計畫？或者有什麼其他因素可能導致耐用醫療設備（DME）的強度超出我的預期？

Yeah, good question, Frank. The outperformance in DME, of course, is just mostly driven by new patients starts exceeding expectations, but there actually was some favorability from stocking dynamics in Q3 relative to Q2, and that that created favorability in DME revenue in Q3 relative to Q2.

嗯，問得好，弗蘭克。當然，DME 的優異表現主要得益於新患者數量超出預期，但第三季度相對於第二季度的庫存動態也帶來了一些有利因素，這使得第三季度 DME 的收入相對於第二季度有所增長。

They're actually -- and you didn't ask about this, but there's actually the inverse impact we saw in the pharmacy supply kit revenue. There was an unfavorable stocking dynamic or had an unfavorable impact on revenue in Q3 relative to Q2.

實際上——雖然你沒問到這一點，但我們確實在藥局用品包收入中看到了相反的影響。與第二季相比，第三季庫存動態不利，或對收入產生了不利影響。

And what I mean by this in the case of DME is that the DME customers ended their quarter with more inventory on their shelves in Q3 than they did in Q2, creating again what I would call a favorable stocking dynamic in Q3.

就 DME 而言，我的意思是，DME 客戶在第三季末的貨架庫存比第二季末的庫存更多，再次創造了我所說的第三季有利的庫存動態。

Got it. Okay, that's helpful. Thank you for that. And then maybe on the bihormonal timeline, I know you guys are talking about the feasibility study, but how should we maybe think about when you guys might formalize a cleaner timeline kind of similar to how you've talked about patch end of 2027? Will you do that with the bihormonal pump in the near future? How should we think about that?

知道了。好的，這很有幫助。謝謝。然後，關於雙激素療法的時間表，我知道你們正在討論可行性研究，但我們應該如何考慮你們何時才能製定一個更清晰的時間表，類似於你們之前提到的在 2027 年底推出補丁？您會在不久的將來使用雙激素幫浦嗎？我們該如何看待這個問題？

Yeah, Frank, look, we love nothing more than to give you a solid timeline on the bihormonal product, but -- and we obviously have internal expectations on that that we have not shared. However, given the complexity of that particular product being having to get both [CDH] SEDAR on the same page in terms of what a pivotal clinical trial looks like and all the requirements around the drug, and frankly, our own evolution into a drug company as well.

是的，弗蘭克，聽著，我們最希望的就是能給你一個關於雙激素產品的確切時間表，但是——而且我們顯然對此有一些內部預期，但我們還沒有和大家分享。然而，考慮到該產品的複雜性，需要讓 [CDH] SEDAR 在關鍵性臨床試驗的形式和藥物的所有要求方面達成一致，坦率地說，也考慮到我們自身向製藥公司發展的過程。

I think it would be a little bit premature to start putting timelines on the mat now, because frankly, they could evolve as we learn and as we get the agency, both halves of the agency on the same page of what it is that we're doing here, so not just yet but please be assured that we're working toward getting most importantly the product out the door as soon as we possibly can but of course, the next step will be to help you all understand the timelines on that as soon as we can.

我認為現在就制定時間表還為時過早，因為坦白說，隨著我們不斷學習，以及公司上下就我們正在做的事情達成共識，時間表可能會有所調整。所以現在還不是時候，但請放心，我們正在努力盡快將產品推向市場，當然，下一步我們將盡快幫助大家了解相關的時間表。

But in the meantime, hopefully, you do see that we continue to make progress on the product, including, as I said, the completion of PK/PD and the soon implementation of the new feasibility trial which we're excited about.

但同時，希望您能看到我們在產品方面繼續取得進展，包括我剛才提到的 PK/PD 研究的完成以及即將實施的新可行性試驗，我們對此感到非常興奮。

Jeff Johnson, Baird.

傑夫·約翰遜，貝爾德。

Yeah, thanks. Good evening, guys. So Sean, maybe on the bihormonal question there, even if you can't put a timeline out there, which I understand, can you just remind us, we're so accustomed to 510(k) pathways here in the diabetes space, we know the kind of six-month review processes, we know these tend to be 13-, 26-week trials, things like that.

嗯，謝謝。晚上好，各位。所以肖恩，關於雙激素的問題，即使你不能給出時間表（我理解），你能提醒我們嗎？我們已經習慣了糖尿病領域的 510(k) 途徑，我們知道那種六個月的審查流程，我們知道這些試驗往往是 13 週、26 週等等。

Once you do start a pivotal, how long would a pivotal for a bihormonal run as far as from in a single patient? I know it takes a while to enroll a first patient in, the last patient in and all that. We'd have to estimate, but I guess my question is more how long would the study last on a per patient visit -- or per patient basis?

一旦開始一項關鍵性試驗，對於單一患者而言，雙荷爾蒙療法的關鍵性試驗通常會持續多久？我知道招募第一位患者、招募最後一位患者等等都需要一段時間。我們得估算一下，但我更想問的是，每次就診或以患者計算，這項研究需要多長時間？

And then how do we think about the review timeline once you do get that data and submitted to the agencies, how long a review process could last?

那麼，一旦獲得這些數據並提交給相關機構，我們應該如何考慮審查時間表？審查過程可能需要多長時間？

Yeah, a great question, Jeff. The ICH guidelines dictate that for a chronic drug indication, we need a year's worth of data on an individual patient. So to your point, plus enrollment, et cetera, but the trial itself will run at least a year on at least one -- well, not at least one, on a number of patients.

是的，傑夫，問得好。ICH 指引規定，對於慢性藥物適應症，我們需要一名患者一年的資料。所以，正如你所說，除了招募等因素外，試驗本身至少會在一名——不，不是至少一名，而是多名患者身上進行一年。

And then, timelines for enrollment, timelines for review of that data, early interactions with the agency, but then the actual NDA submission itself, I believe, is a year.

然後，還有註冊時間表、資料審查時間表、與機構的早期互動，但我認為，實際提交 NDA 本身需要一年時間。

One year on that too, yeah, okay, that helps. Thanks. I'm not a pharma guy, so never strong there. But also then Stephen, maybe can you just maybe quantify for us the stocking headwind in pharmacy and the stocking tailwind in DME at all and how much of that was on supply side?

一年過去了，嗯，好吧，這很有幫助。謝謝。我不是搞醫藥的，所以這方面不太擅長。另外，Stephen，你能否為我們量化一下藥房的庫存逆風和耐用醫療設備 (DME) 的庫存順風，以及其中有多少是供應方面的因素？

Just as we look at the supply revenue this quarter on a per patient basis in the pharmacy channel, it came down about 10%, 12% or so sequentially. And we keep trying to wrestle with how much of that is attrition versus stocking dynamics and all that. So just maybe help us quantify, especially in the pharmacy channel, maybe what that stocking headwind was in the quarter?

正如我們本季按藥房管道每位患者計算的供應收入一樣，它環比下降了約 10% 到 12%。我們一直在努力弄清楚其中有多少是自然損耗，又有多少是庫存動態等等因素造成的。所以，能否請您幫忙量化一下，尤其是在藥局管道，本季庫存方面的不利因素是什麼？

Yeah, of course.

當然。

I have two parts to this answer. First part is that I'm not going to quantify the exact dollar amount of the stocking impact in DME versus pharmacy, but the two offset one another, nearly $1 for $1 in the quarter. So net neutral stocking impact with again favorability in DME, unfavorability in pharmacy.

我的回答分為兩部分。首先，我不會量化DME和藥局庫存影響的具體金額，但兩者相互抵消，季度內幾乎是1比1。因此，淨庫存影響為中性，DME 再次呈現有利態勢，而藥局則呈現不利態勢。

And then on a sec, on your point about attrition and retention, while I'm not going to share retention rate or attrition rate, even though I know we get asked about it consistently, and this is for reasons that I think we've been very clear about, most notably that the competition doesn't share attrition or retention rates.

再說一下，關於您提到的流失率和留存率，雖然我知道我們經常被問到這個問題，但我不會透露留存率或流失率，原因我們已​​經解釋得很清楚了，最主要的是競爭對手不會透露流失率或留存率。

I do want to point to one output of your model, Jeff, and I guess any investor or analyst that has a has a model that I would sort of maybe alleviate maybe your feeling on that question. So if you look at the metric that I want to point your attention to is the number of pharmacy supply kits per pharmacy patient per quarter.

傑夫，我想指出你模型的一個輸出結果，我想任何擁有模型的投資者或分析師，或許都能從中得到一些啟發，從而緩解你對這個問題的疑慮。因此，我想提請大家注意的指標是每個藥局患者每季獲得的藥局用品包數量。

And so the math there, what you can do, how to do the math to get to that metric is you'll take the pharmacy revenue, pharmacy supply revenue, I should say, in the given quarter, divide that by the price of each pharmacy supply kit, which you know is roughly $450 because that's what we've said. And then divide that again by your belief of what the pharmacy installed base is.

所以，計算方法是，你可以用給定季度的藥房收入（或者應該說是藥房供應收入）除以每個藥房供應包的價格，你知道這個價格大約是 450 美元，因為我們之前說過。然後，再用你認為的藥局現有客群數量除以這個結果。

So that's again -- it's pharmacy revenue in the given quarter divided by the price, $450, and then divided again by the pharmacy installed base. And what you're going to find when you run that metric in this quarter and in all of the most recent quarters is that that metric is well over, well in excess of three, and that's regardless of what attrition rate or retention rate assumption you use in your model, no matter how low you would choose the attrition or the attrition rate to be.

所以，這又是——用給定季度的藥房收入除以價格 450 美元，然後再除以藥房的安裝基數。當你在本季度以及最近所有季度運行該指標時，你會發現該指標遠遠超過 3，無論你在模型中使用什麼流失率或留存率假設，無論你選擇多低的流失率或流失率，情況都是如此。

And what does that say? If it's above three, well, remember that a patient only uses one pharmacy supply kit per month. And so that you would use three per quarter. So by very virtue of that number, which is again an output in your model, by that being above three, I think that illustrates why there's not a retention or attrition issue at the business.

那又說明了什麼呢？如果超過三，請記住，患者每月只能使用一套藥房用品包。這樣一來，你每季就會用到三個。因此，僅憑這個數字（這也是你模型中的一個輸出），由於它大於 3，我認為這就說明了為什麼公司不存在員工留存或流失問題。

So I guess I -- hopefully that was helpful, but again, I'm not going to talk specifically about attrition or retention, the number for reasons that we've communicated in the past.

所以我想我——希望這有所幫助，但再次聲明，我不會具體談論人員流失或留存率，原因我們過去已經溝通過了。

Yeah, no, that math is helpful. That's exactly how we run it in our model, I guess it's just -- we're trying to understand the 40% decline we've seen in per patient per pharmacy over the last 2.5 quarters.

是的，沒錯，數學很有用。我想，這正是我們模型運作的方式，我們只是想了解過去 2.5 個季度中，每位患者每家藥局的用藥量下降了 40% 的原因。

So I think the other thing to remember is that you're going to see like again big deviations in that metric from quarter to quarter, meaning, yeah, you did see a downtake in it this quarter. You've also seen uptakes in the same metric if you looked over trending over quarter to quarter. And what that really points out is that there are fluctuations in pharmacy stocking and it does have a material impact on our revenue in a given quarter.

所以我覺得需要記住的另一點是，你會看到該指標每季之間出現很大的偏差，也就是說，是的，你確實看到本季該指標有所下降。如果你觀察季度間的趨勢，也會發現同一指標有所成長。這實際上表明，藥房的庫存存在波動，並且會對特定季度的收入產生實質影響。

But really, the reason why there's this is so much fluctuation is just think about how much our pharmacy demand has changed. We've gone from our guidance being low teens or low-double-digit percentage, up to now we're in the low 30s. And so pharmacy distribute -- pharmacy customers don't really know how much to order to keep up with demand, and that's a part of why you're seeing big fluctuations.

但實際上，造成這種如此大波動的原因，想想我們對藥品的需求發生了多大的變化就知道了。我們之前的指導值是十幾個百分點或兩位數的低百分比，而現在已經達到了三十個百分點左右。因此，藥局的配送－藥局的顧客並不清楚應該訂購多少才能滿足需求，這也是你看到價格大幅波動的原因之一。

Understood. Thank you.

明白了。謝謝。

Richard Newitter, Truist Securities.

Richard Newitter，Truist Securities。

All right, thanks for taking the questions and congrats on the quarter. Maybe just on the pharmacy channel on the percentage here, so you're obviously exceeding your expectations, our model and I think consensus too you're exiting, you're on track to exit at a low 30%. Did you know -- let's just think through where this percentage could reasonably get to or where we should not be, what threshold we shouldn't be exceeding before you potentially on commercial with a patch?

好的，謝謝你們回答問題，也恭喜你們本季取得好成績。或許只是藥房管道的百分比，所以你顯然超出了預期，我們的模型和我認為的共識也是，你正在退出，你正按計劃以 30% 的低位退出。你知道嗎——讓我們仔細想想這個百分比可能達到的合理範圍，或者我們不應該達到的範圍，在你有可能使用補丁進行商業推廣之前，我們不應該超過的閾值是什麼？

Is this something that could be 50% exiting 2026? What's the threshold that we should be thinking about or put some book ends around it as we fine tune our models because clearly, you're exceeding -- you're exceeding where we all had you on the trajectory.

到 2026 年，這種情況發生的可能性會達到 50% 嗎？我們應該考慮的閾值是什麼？或者說，在微調模型時，我們應該給它設定一些界限嗎？因為很明顯，你已經超越了——你已經超越了我們所有人對你軌蹟的預期。

Yeah, I appreciate the question. Frankly, the frustrating answer for us and you is that we don't know. We're doing something nobody's ever done before and that's push a durable pump through the pharmacy channel. To your point, we've exceeded our own expectations on what we can do there. We hope that those exceedances continue and that we can get even farther than even we think we can.

是的，感謝你的提問。坦白說，令我們和你們都感到沮喪的答案是我們不知道。我們正在做一件前所未有的事情，那就是透過藥局管道推廣耐用型幫浦。正如您所說，我們在那裡所取得的成就已經超出了我們自己的預期。我們希望這種超越預期的勢頭能夠繼續下去，並且我們能夠取得比我們自己想像中更大的成就。

But it's very hard for us to make a prediction on that, and I don't think we're frankly in any better position to do it than anybody else. We're just forced with going out and actually doing the work, so I'm sorry we can't make that prediction. But what I will tell you is that we'll try and make that number as high as we absolutely can.

但我們很難對此做出預測，坦白說，我認為我們在這方面並不比其他人更有優勢。我們只能被迫出去實際工作，所以很抱歉我們無法做出預測。但我可以告訴你們的是，我們會盡一切努力讓這個數字達到盡可能高的目標。

Okay, fair enough. And then just on type 2 indication, I think, Sean, you've talked in the past that it's not something that you necessarily -- it's precluding you from moving that percentage higher. It was a little flat this quarter. I'm just curious, anything you're seeing that we have multiple players out there with an official indication and data?

好吧，這說得有道理。然後，就 2 型指標而言，我認為，肖恩，你過去曾說過，這並不是你——它不會阻止你將這個百分比提高。本季業績略顯平淡。我只是好奇，你有沒有看到有多名玩家擁有官方數據和相關跡象？

And you mentioned you're not going to commit to precisely the strategy and timing of what you're going to do to ultimately secure an indication. But if you could elaborate on how you're thinking about that and what your options are? Thanks.

你提到你不會具體承諾採取何種策略和時間安排來最終獲得簽約。但如果您能詳細說明您是如何考慮這個問題的，以及您有哪些選擇呢？謝謝。

Yeah, the first thing I would say is that I wouldn't look at it as flat. The percentage was the same, and our new patients starts -- obviously, they grew, I don't think there's any benefit to Beta Bionics to grow that 30% or roughly 30% to roughly 25%, excuse me, to something much larger. I mean, we need to grow our total new patient starts.

是的，首先我要說的是，我不會把它看作是扁平的。百分比保持不變，而我們的新患者數量——顯然，他們增加了，我認為 Beta Bionics 沒有必要將 30% 或大約 30% 的比例提高到大約 25%，抱歉，提高到更大的比例。我的意思是，我們需要增加新患者總數。

And to your point, we're not really out selling it, so it kind of is what it is on a percentage basis and that's okay. There's some other things that go into the dynamic as to whether or not we would make the decision to invest in that or when we make the decision to invest in that is what I should say, that I probably just can't get into at this stage, because they result or they relate to some internal product pipeline stuff.

正如你所說，我們的銷量並沒有真正超過競爭對手，所以從百分比來看，情況就是這樣，這也沒什麼大不了的。還有一些其他因素會影響我們是否決定投資，或何時決定投資，我應該說的是，這些因素在現階段我可能無法詳細說明，因為它們與一些內部產品線相關。

But yeah, I don't know, I would say that we're doing as well as anybody effectively in that channel and we don't even have the indication, so yeah, leave it at that.

但是，嗯，我不知道，我想說我們在這個管道上做得和任何人一樣好，而且我們甚至還沒有相關數據，所以，嗯，就說到這裡吧。

Okay, thank you.

好的，謝謝。

Jon Block, Stifel.

Jon Block，Stifel。

I need to call out regarding just the competitive landscape. There's really been a good amount of focus there with the new entrant, but your competitive wins as a percent of ads actually ticked up a bit Q over Q, and obviously, you had a huge growth rate if we look at it year over year. So just any color you can provide there with the landscape maybe changing or maybe not?

我需要就競爭格局提出一些看法。雖然新進業者確實受到了相當多的關注，但你的廣告勝出率（佔廣告總數的百分比）實際上環比略有上升，而且顯然，如果我們從同比來看，你的成長率非常高。所以，只要你能提供任何顏色，景觀可能會變化，也可能不會改變？

Short answer is no. It is a highly competitive industry. It's competitive not only just for recruiting the right type of sales reps, but every account has a lot of different sales reps that are trying to sell and get the attention of the HDP at that given account. But we're confident in what we have.

簡而言之，答案是否定的。這是一個競爭非常激烈的行業。競爭不僅在於招募合適的銷售代表，而且每個客戶都有許多不同的銷售代表試圖向該客戶推銷產品並引起HDP的注意。但我們對我們所擁有的充滿信心。

We have a highly differentiated product, the easiest system on the market we believe to use for doctors, for patients, compelling solution with the pharmacy reimbursement. And so I don't see the market or the competitive landscape as meaningfully different than it was semi recently, and we feel confident.

我們擁有高度差異化的產品，我們相信它是市場上最簡單易用的系統，對醫生和患者來說都是極具吸引力的藥房報銷解決方案。因此，我認為市場或競爭格局與不久前相比並沒有實質的不同，我們對此充滿信心。

All good. Stephen, maybe I'll stick with you. I'm struggling with the guidance from gross margins in a good way, and I know you gave some reasons. You sort of said, hey it implies flattish just slightly up GMs Q over Q for 4Q, but your pharmacy mix is largely consistent, or the assumption is with 3Q. And we've seen a lot of scale right throughout 2025 when you just look at your sequential gross margin improvement despite pharmacy ramping as an overall percentage.

一切都好。史蒂芬，也許我會跟著你。我正在努力理解毛利率的指導意義，我知道您也給了一些理由。你好像說過，嘿，這意味著第四季度通用汽車的業績將略微持平，但你的藥房組合基本上保持一致，或者說，假設與第三季度一致。即使考慮到藥房產能擴張的總體百分比，我們也看到，從 2025 年全年來看，毛利率的連續增長幅度很大。

So can you just tell me why like that improving scale dynamic wouldn't resonate as much if you would in 4Q '25? Or is this maybe just leaving a little bit of wiggle room considering you really don't know the percentage DME versus pharmacy because of the deductible metric you brought up earlier? Thanks for your time.

所以你能告訴我為什麼，如果在 2025 年第四季改進規模動態，就不會引起那麼大的迴響嗎？或者，考慮到您之前提到的免賠額指標，您實際上並不知道 DME 與藥品之間的百分比，這或許只是留了一些迴旋餘地？感謝您抽出時間。

Of course. On the high end of the range, the gross margin guidance for Q4 is actually in line with the increase or the increase that we're guiding to in Q4 revenue. So the increase in scale and the benefit that we would get the gross margin is actually sort of in line again with the revenue increase quarter over quarter. But on the low end of the range, you're right, that may like seem a little surprising to you that we're guiding to that low.

當然。從預期範圍的高端來看，第四季的毛利率指引實際上與我們預期的第四季營收成長相符。因此，規模的擴大以及由此帶來的毛利率成長，實際上與季度環比的營收成長又基本一致。但是，就價格區間的低端而言，你說得對，我們引導到如此低的價格可能會讓你感到有些驚訝。

Really, it just comes down to lack of predictability around the pharmacy reimbursement channel. There is a world where in Q4 we out outperform our expectations in pharmacy, which actually creates in terms of new patient starts, and what would that do is it would create a short-term headwind to revenue and gross margin, and that's one reason.

說到底，問題就在於藥局報銷管道缺乏可預測性。第四季度，我們在藥房業務方面的表現超出了預期，這實際上會增加新患者的數量，而這將對收入和毛利率造成短期不利影響，這是其中一個原因。

And the second is that cost of sales, well, look, we like to set -- the guidance philosophy around here is for metrics like this, we like to set expectations at a level that we have a high degree of confidence in. And with cost of sales, there can at times be things that are semi unpredictable that could come up and be a one-time charge.

第二點是銷售成本，嗯，你看，我們喜歡設定——我們這裡的指導理念是，對於這類指標，我們喜歡將預期設定在我們非常有信心的水平上。在銷售成本中，有時會出現一些難以預料的情況，這些情況可能會產生一次性費用。

I'm not suggesting I see any of those in Q4, but that can happen. And so hence we like to be, I guess, a little cautious with large uptakes and gross margin guidance for that reason.

我並不是說我會在第四季看到這些，但這也不是不可能。因此，我想，基於這個原因，我們對大規模銷售和毛利率預期會比較謹慎。

Jeffrey Cohen, Ladenburg Thalmann & Company.

Jeffrey Cohen，Ladenburg Thalmann & Company。

Congrats on a strong quarter. Just one for us. If you could maybe talk about your special 510(k). Was this software only and was this uploaded to all the units out there and does that help or would that help in Mint development or some of those updates being embedded into Mint now?

恭喜你們本季業績出色。我們只留一個。如果您能談談您的特殊 510(k) 計劃就好了。這個軟體僅僅是軟體嗎？它是否已上傳到所有設備？這對 Mint 的開發或將某些更新嵌入到 Mint 中是否有幫助？

Yeah, it's a software upgrade and as with all of our software upgrades, that's something that all of our users get a chance to download and use. And in fact, we always like to push people to our newest software.

是的，這是一次軟體升級，就像我們所有的軟體升級一樣，所有用戶都有機會下載和使用。事實上，我們總是樂於向用戶推廣我們最新的軟體。

I would say that part of those software upgrades are related to Mint and some not, some of the way we do the alarms and what alerts and alarms certainly will be reflected in Mint. Cartridge change process, of course, has nothing to do with Mint whatsoever.

我認為，這些軟體升級一部分與 Mint 有關，一部分則無關，我們設定警報的方式以及警報內容肯定會在 Mint 中有所體現。當然，墨盒更換過程與Mint公司沒有任何關係。

So yes and no, but as with anything where Beta Bionics considers ourselves to be primarily user innovation, user experience company, I should say. And to the extent that those user experience things are applicable to Mint will absolutely reflect them in that.

所以，可以說是，也可以說不是。但是，就像 Beta Bionics 認為我們主要是一家使用者創新、使用者體驗公司一樣，我應該這麼說。如果這些使用者體驗方面的因素適用於 Mint，那麼它們也一定會體現在 Mint 中。

David Roman, Goldman Sachs.

大衛羅曼，高盛集團。

Thank you. I appreciate you taking the follow-up and I hate to focus on the 483, but the mod dynamic has become such a distraction for investors into the quarter. And as we think about the kind of remediation process here, that does have the potential just to create some noise for people out there counting up mod reports or just sort of like a meaningless metric, but it does get a lot of attention.

謝謝。感謝您跟進，雖然我不想把注意力集中在 483 上，但這種動態變化已經嚴重分散了投資者在本季度的注意力。當我們思考這裡的補救措施時，它確實有可能給那些統計作弊舉報的人帶來一些噪音，或者只是一種毫無意義的指標，但它確實引起了很多人的注意。

So can you maybe just help us frame like how we should think about those reports when we see them, how to interpret the remediation, filings, and just maybe help us kind of calm the obsession with counting mod entries?

所以，您能否幫助我們理清思路，例如當我們看到這些報告時應該如何看待它們，如何解讀補救措施和備案文件，以及能否幫助我們冷靜下來，不再那麼執著於統計修改條目的數量？

Great question. Well, from our perspective, this is something that every company in the diabetes spaces has gone through at one time or another. I think, as Stephen alluded to, the guidelines associated with what constitutes a complaint or a report, I should say, are unclear at best, and we've all had to align our understandings with that of the agency.

問得好。從我們的角度來看，這是糖尿病領域的每家公司都曾經歷過的事情。我認為，正如史蒂芬所暗示的那樣，關於什麼構成投訴或舉報的指導方針充其量也只是不明確，我們都不得不讓自己的理解與該機構的理解保持一致。

For anybody who really wants to dig in, I guess I encourage you to, you can go to the mod database, that's the whole point of the thing, and you can look what's being submitted. And in our case, the case of any other company out there, you can look at rates. We've been fairly transparent with what our installed bases, et cetera.

對於任何真正想深入了解的人，我鼓勵你們去看看，你們可以存取模組資料庫，這才是關鍵所在，你們可以看看有哪些模組被提交了。就我們公司而言，或就任何其他公司而言，您可以查看費率。我們一直對我們的用戶基數等情況保持相當透明的態度。

And you can compare those things and we think we compare favorably, but in terms of how to think through it beyond that, I'd say that's hard to say. We don't see an underlying problem in our data here. The 483 itself had nothing to do with the actual complaints being received or the number of them. It had to do solely with the definition of the reports being filed as complaints, and that's all.

你可以比較這些方面，我們認為我們在這方面表現不錯，但要進一步思考這個問題，我覺得很難說。我們從數據中沒有發現任何根本性問題。483 這個數字本身與實際收到的投訴或投訴數量無關。這完全與將提交的報告定義為投訴有關，僅此而已。

So hopefully, that's clear.

希望這一點很清楚了。

Very. Appreciate you taking the additional question.

非常。感謝您回答我的補充問題。

No problem.

沒問題。

Not at all.

一點也不。

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Sean for any closing remarks.

謝謝。我目前不再提出其他問題。我想把電話交還給肖恩，讓他做最後的總結發言。

All right, thanks, everyone. As usual, we enjoyed discussing a strong quarter with you today. We appreciate your work to understand our business, and I guess we look forward to seeing you all next quarter.

好的，謝謝大家。今天和往常一樣，我們很高興和大家討論本季強勁的業績。我們感謝您為了解我們的業務所做的工作，我們期待下個季度能再次見到您。

Thank you.

謝謝。

Yeah, thanks, everyone.

是啊，謝謝大家。

Thank you for your participation. You may now disconnect. Good day.

感謝您的參與。您現在可以斷開連線了。再會。