Embecta Corp (EMBC) 2024 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Welcome, ladies and gentlemen, to the fiscal second-quarter-2024 Embecta earnings conference call. (Operator Instructions) Please note that this conference call is being recorded and the recording will be available on the company's website for replay following the completion of this call.

    女士們、先生們,歡迎參加 Emecta 2024 年第二季財報電話會議。(操作員說明)請注意,本次電話會議正在錄音,錄音將在公司網站上提供,以便在本次電話會議結束後重播。

  • I would now like to hand the conference call over to your host today, Mr. Pravesh Khandelwal, Vice President of Investor Relations. Please go ahead.

    現在我想將電話會議交給今天的東道主,投資者關係副總裁 Pravesh Khandelwal 先生。請繼續。

  • Pravesh Khandelwal - VP, Head of IR

    Pravesh Khandelwal - VP, Head of IR

  • Thank you, operator. Good morning, everyone, and welcome to Embecta's fiscal second-quarter-2024 earnings conference call. The press release and slides to accompany today's call and webcast replay details are available on the Investor Relations section of the company's website at www.embecta.com. With me today are Dev Kurdikar, Embecta's President and Chief Executive Officer; and Jake Elguicze, our Chief Financial Officer.

    謝謝你,接線生。大家早安,歡迎參加 Embecta 2024 年第二季財報電話會議。今天電話會議的新聞稿和幻燈片以及網路廣播重播的詳細資訊可在公司網站 www.embecta.com 的投資者關係部分取得。今天和我在一起的有 Embecta 總裁兼執行長 Dev Kurdikar;和我們的財務長 Jake Elguicze。

  • Before we begin, I would like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, which can be accessed on our website.

    在我們開始之前,我想提醒您,電話會議中討論的一些事項將包含有關幻燈片中概述的未來事件的前瞻性陳述。我們希望提醒您,此類陳述實際上具有前瞻性,並存在風險和不確定性,實際事件或結果可能存在重大差異。可能導致實際結果或事件出現重大差異的因素包括但不限於我們今天的新聞稿中提到的因素以及我們向 SEC 提交的文件(可以在我們的網站上存取)。

  • In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in our press release and conference call presentation.

    此外,我們將在本次電話會議上討論某些非公認會計原則財務措施,這些措施應被視為根據公認會計原則準備的財務措施的補充,而不是替代。我們的新聞稿和電話會議簡報中包含了這些非公認會計準則衡量標準與可比較公認會計準則衡量標準的調整。

  • Our agenda for today's call is as follows. Dev will begin by providing some remarks on the overall performance of our business during the fiscal second quarter of 2024 as well as an overview of our strategic priorities. Jake will then provide a more in-depth review of our Q2 financial results as well as our updated financial guidance for the year. We will then open the call for questions.

    我們今天的電話會議議程如下。Dev 將首先對 2024 財年第二季我們業務的整體業績進行一些評論,並概述我們的策略重點。然後,傑克將對我們第二季的財務業績以及今年更新的財務指引進行更深入的審查。然後我們將開始提問。

  • With that said, I would now like to turn the call over to our CEO, Dev Kurdikar. Dev?

    話雖如此,我現在想將電話轉給我們的執行長 Dev Kurdikar。開發?

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Good morning, and thank you for taking the time to join us. Let's start with our strategic priorities on slide 5. We remain committed to the same trio of strategic priorities that have guided us since we established our service as an independent company. These priorities form the basis of our decisions and actions, and they are: remaining focused on strengthening our base business while maintaining our global leadership position in the category of insulin injection devices; separating ourselves from our former parent in a thoughtful manner to mitigate risk and position us for long-term success as an independent company; and finally, investing in growth, most notably around our insulin patch pump program that is being developed for the type 2 market, as well as seeking M&A and additional partnership opportunities. During this past quarter, we made significant progress within each of these goals.

    早安,感謝您抽出寶貴時間加入我們。讓我們從投影片 5 上的策略重點開始。我們仍然致力於自我們作為一家獨立公司建立服務以來一直指導我們的三大策略重點。這些優先事項構成了我們決策和行動的基礎,它們是: 繼續專注於加強我們的基礎業務,同時保持我們在胰島素注射設備領域的全球領導地位;以深思熟慮的方式將我們與前母公司分開,以降低風險並使我們作為一家獨立公司取得長期成功;最後,投資於成長,尤其是圍繞我們為 2 型市場開發的胰島素貼片幫浦專案進行投資,以及尋求併購和其他合作機會。在過去的這個季度,我們在每個目標方面都取得了重大進展。

  • Turning to some second quarter highlights. The second quarter was a strong quarter for Embecta, one in which we generated approximately $287 million in revenue, which represented an increase of 3.6% on an as-reported basis and 4.5% on a constant currency basis. When normalizing for the transient contract manufacturing revenue that we generate based on sales of non-diabetes products to our former parent, our constant currency revenue grew 4.9% as compared to the prior year period.

    轉向第二季的一些亮點。第二季度對 Embecta 來說是一個強勁的季度,我們產生了約 2.87 億美元的收入,按報告計算增長了 3.6%,按固定匯率計算增長了 4.5%。當我們根據向前母公司銷售非糖尿病產品而產生的臨時合約製造收入正常化時,我們的固定貨幣收入與去年同期相比增長了 4.9%。

  • This solid performance exceeded our expectations and occurred while simultaneously implementing our own ERP system, operationalizing our new distribution network including seven new distribution centers, and standing up shared services capability in markets comprising 25% of our revenue in over 100 countries and serving approximately 5,000 customers. We also implemented these systems and processes in our third manufacturing plant.

    這一穩健的業績超出了我們的預期,同時實現了我們自己的ERP 系統、運營了包括七個新配送中心在內的新分銷網絡,並在100 多個國家/地區占我們收入25% 的市場中建立了共享服務能力,為大約5,000 名客戶提供服務。我們還在我們的第三個製造工廠實施了這些系統和流程。

  • Thus, at the end of the second quarter, we have completed the implementation of our ERP system and operationalized our distribution network and shared service capability across approximately 85% of our revenue base, servicing customers in US, Canada, EMEA and parts of Asia and at all three of our manufacturing plants in the US, Ireland and China.

    因此,在第二季末,我們已經完成了ERP 系統的實施,並在我們約85% 的收入基礎上運營了我們的分銷網絡和共享服務能力,為美國、加拿大、歐洲、中東和非洲以及亞洲部分地區的客戶提供服務。

  • Additionally, we successfully completed the remaining steps in the demerger process for our manufacturing entity in China and have transitioned its legal ownership from BD to Embecta. We have also resumed manufacturing at this facility for products for supply to our customers in China. We have previously commented that this facility was producing goods for export to other markets. So now, the plant is fully operational.

    此外,我們成功完成了中國製造實體分拆過程中的剩餘步驟,並將其合法所有權從 BD 轉移到 Embecta。我們也恢復了該工廠的生產,為中國客戶供應產品。我們之前曾評論過,該工廠正在生產出口到其他市場的商品。現在,該工廠已全面投入運作。

  • All of these accomplishments were achieved in alignment with our projected timelines. The transfer of ownership of this important plant from BD to Embecta and the restarting of domestic China production marks the completion of a significant separation project that our team has been meticulously working on since prior to our spin-off date.

    所有這些成就都是按照我們預計的時間表實現的。這個重要工廠的所有權從 BD 轉移到 Embecta 以及中國國內生產的重啟,標誌著我們團隊自分拆日期之前就一直在精心開展的一項重要分離項目的完成。

  • Lastly, as it relates to separation activities, to facilitate the phased implementation of our ERP solution, distribution network and shared services capabilities, we had requested an extension for certain TSAs and related agreements from BD. BD granted that limited extension, which has allowed us to implement our ERP system and associated distribution and shared services capabilities in a phased manner with the goal of completing these implementations in all markets except in certain limited deferred closing jurisdictions by early fiscal year 2025. It goes without saying that these implementations are highly intricate, and I'm proud of our team for bringing these complex projects to near completion.

    最後,由於涉及分離活動,為了促進我們的 ERP 解決方案、分銷網絡和共享服務能力的分階段實施,我們已要求 BD 延長某些 TSA 和相關協議。BD 批准了有限延期,這使我們能夠分階段實施我們的ERP 系統以及相關的分銷和共享服務功能,目標是到2025 財年年初在除某些有限延遲關閉管轄區之外的所有市場中完成這些實施。不用說,這些實現非常複雜,我為我們的團隊使這些複雜的專案接近完成感到自豪。

  • Related to our objective of entering the infusion pump market, we sponsored the publication of a paper titled, Opportunities to Overcome Underutilization of Enhanced Insulin Delivery Technologies in People with Type 2 Diabetes: A Narrative Review. This paper aims to inform health care providers, particularly primary care physicians and those less familiar with technology about the benefits of insulin pumps for people with type 2 diabetes. It highlights the safety and effectiveness of innovative technologies like insulin delivery systems in improving glycemic outcomes.

    與我們進入輸液幫浦市場的目標相關,我們贊助發表了一篇題為《克服 2 型糖尿病患者強化胰島素輸送技術利用不足的機會:敘述性評論》的論文。本文旨在告知醫療保健提供者,特別是初級保健醫生和那些不太熟悉技術的人,了解胰島素幫浦對第 2 型糖尿病患者的好處。它強調了胰島素輸送系統等創新技術在改善血糖結果方面的安全性和有效性。

  • Despite the proven efficacy, these technologies are often overlooked in primary care settings. The review explores the clinical and economic advantages of tubeless insulin delivery devices and explains how this technology can address common challenges associated with traditional insulin delivery methods. And speaking of insulin patch pumps, we continue to make progress in terms of insulin patch pumps that are being developed. I'll share more about these accomplishments in the following slide.

    儘管功效已得到證實,但這些技術在初級保健機構中經常被忽視。這篇綜述探討了無管胰島素輸送裝置的臨床和經濟優勢,並解釋了該技術如何解決與傳統胰島素輸送方法相關的常見挑戰。說到胰島素貼片泵,我們在正在開發的胰島素貼片泵方面不斷取得進展。我將在下一張幻燈片中分享有關這些成就的更多資訊。

  • To summarize, during the second quarter, strong operational execution led to results that exceeded our internal expectations. And based on these results, we are raising and tightening our guidance range for key financial metrics, which Jake will be discussing later.

    總而言之,第二季度,強勁的營運執行力帶來了超越我們內部預期的業績。根據這些結果,我們正在提高和收緊關鍵財務指標的指導範圍,傑克將在稍後討論這一點。

  • Turning to the advancements we made in terms of our insulin patch pump program. Our 510(k) application for the open-loop version of our insulin patch pump continues to be under FDA review, and we continue to have ongoing dialogue with the FDA. As a reminder, we submitted our 510(k) application to the FDA in late calendar year 2023.

    談談我們在胰島素貼片幫浦專案方面的進步。我們的胰島素貼片幫浦開環版本的 510(k) 申請繼續接受 FDA 審查,並且我們將繼續與 FDA 進行持續對話。謹此提醒,我們於 2023 年底向 FDA 提交了 510(k) 申請。

  • In parallel, during the second quarter, we also continued the development of a closed-loop insulin patch pump that is targeted towards those individuals who have type 2 diabetes, including further collaborating with Tidepool concerning the adaptation of their FDA-approved type 1 algorithm into a type 2 algorithm that could be used in our closed-loop insulin patch pump system. As we continue to progress throughout this year, we will continue to provide updates to the investment community regarding the status of FDA's review at the appropriate time as well as progress we made regarding our closed-loop type 2 patch pump.

    同時,在第二季度,我們也繼續開發針對 2 型糖尿病患者的閉環胰島素貼片泵,包括與 Tidepool 進一步合作,將其 FDA 批准的 1 型演算法調整為一種2 型演算法,可用於我們的閉環胰島素貼片幫浦系統。隨著我們今年繼續取得進展,我們將繼續在適當的時間向投資界提供有關 FDA 審查狀態的最新資訊以及我們在閉環 2 型貼片泵方面取得的進展。

  • Lastly, I would like to provide a review of our second-quarter revenue performance in a bit more detail. As I mentioned at the outset, during Q2, we generated revenue of $287.2 million, which represented an increase of 3.6% on an as-reported basis and an increase of 4.5% on a constant currency basis or 4.9% when normalizing for the impact of year-over-year changes in the revenue of non-diabetes products that we contract manufacture and sell to BD.

    最後,我想更詳細地回顧一下我們第二季的營收表現。正如我在一開始提到的,第二季度,我們實現了 2.872 億美元的收入,按報告計算增長了 3.6%,按固定匯率計算增長了 4.5%,按照正常化的影響增長了 4.9%。向BD 承包生產和銷售的非糖尿病產品收入的同比變化。

  • Our Q2 revenue exceeded our previously communicated expectations, primarily due to the timing of customer orders in advance of our aforementioned EMEA and parts of Asia focused ERP system and associated capabilities implementations and in advance of a price increase in the US. Q2 revenue also benefited from a better-than-expected product and geographic mix. We estimate that the timing of customer orders impacted our second-quarter results positively by approximately $16 million and we currently expect that the timing benefit will unwind during fiscal Q3.

    我們第二季的收入超出了我們先前傳達的預期,主要是因為客戶訂單的時間安排在我們前面提到的歐洲、中東和非洲和亞洲部分地區重點關注的ERP 系統和相關功能實施之前,以及在美國價格上漲前。第二季營收也受惠於好於預期的產品和地理組合。我們估計,客戶訂單的時間表對我們第二季的業績產生了約 1,600 萬美元的正面影響,我們目前預計時間安排的好處將在第三財季期間消失。

  • Within the US, during the quarter, revenue totaled $147.6 million, which represented a year-over-year growth of approximately 0.8% on a constant currency basis. When normalizing for year-over-year contract manufacturing revenues, our underlying Q2 constant currency revenue growth within the US was approximately 1.5%. Volume was the primary contributor of growth in the quarter, aided by our contract wins with the top-three Medicare Part D plans going into effect in January 2024.

    在美國,本季營收總計 1.476 億美元,以固定匯率計算年增約 0.8%。當合約製造收入較去年同期正常化時,我們在美國第二季的基本固定貨幣收入成長率約為 1.5%。銷售量是本季成長的主要貢獻者,這得益於我們贏得了 2024 年 1 月生效的三大 Medicare Part D 計劃的合約。

  • As we have previously noted, we are the preferred or dual preferred brand on the formularies for these plans. These additional Medicare Part D plan volumes were somewhat offset by the unwinding of certain customer orders that benefited us in our fiscal first quarter as was discussed on our first-quarter earnings call. Pricing was flat in the quarter as compared to the year ago period, which was expected.

    正如我們之前指出的,我們是這些計劃的處方集上的首選或雙重首選品牌。這些額外的醫療保險 D 部分計劃數量在一定程度上被某些客戶訂單的解除所抵消,這些訂單使我們在第一財季受益,正如我們在第一季度財報電話會議上討論的那樣。本季的定價與去年同期持平,符合預期。

  • During Q2, our international revenue totaled $139.6 million, which equated to year-over-year constant currency growth of approximately 8.7%. Growth in our international business was due to increased volumes and can be largely attributed to the timing of certain customer orders in advance of previously mentioned ERP and associated capabilities implementations that occurred within the quarter. Pricing within our international business remained relatively flat.

    第二季度,我們的國際營收總計 1.396 億美元,以固定匯率計算年增約 8.7%。我們國際業務的成長是由於銷售量增加,並且在很大程度上歸因於某些客戶訂單的時間提前於前面提到的 ERP 和本季度內發生的相關功能實施。我們的國際業務定價保持相對穩定。

  • That completes my prepared remarks. And with that, let me turn the call over to Jake to take you through our second-quarter financial results as well as our updated full-year financial guidance in more detail. Jake?

    我準備好的發言就到此結束。接下來,讓我將電話轉給傑克,讓您更詳細地了解我們第二季的財務表現以及更新的全年財務指引。傑克?

  • Jacob Elguicze - Chief Financial Officer, Senior Vice President

    Jacob Elguicze - Chief Financial Officer, Senior Vice President

  • Thank you, Dev, and good morning, everyone. Given the discussion that has already occurred regarding revenue, I will start my review of Embecta’s financial performance for the second quarter at the gross profit line.

    謝謝你,Dev,大家早安。鑑於已經就收入進行了討論,我將從毛利線開始回顧 Embecta 第二季度的財務表現。

  • GAAP gross profit and margin for the second quarter of fiscal 2024 totaled $185.4 million and 64.6%, respectively. This compared to $189.8 million and 68.5% in the prior year period. While on an adjusted basis, our Q2-2024 adjusted gross profit and margin totaled $185.8 million and 64.7%. This compared to $190.1 million and 68.6% in the prior year period.

    2024 財年第二季的 GAAP 毛利和利潤率分別為 1.854 億美元和 64.6%。相比之下,去年同期為 1.898 億美元,成長了 68.5%。在調整後的基礎上,我們 2024 年第二季調整後的毛利和利潤率總計 1.858 億美元,達到 64.7%。相較之下,去年同期為 1.901 億美元,成長 68.6%。

  • The year-over-year decrease in adjusted gross profit and margin was due to the impact of inflation on the cost of certain raw materials, direct labor, freight and overhead; the impact of negative year-over-year manufacturing variances, primarily attributable to the planned temporary shutdown of our Suzhou, China facility as it relates to production for the domestic Chinese market for part of the quarter; and the negative impact of foreign currency translation, primarily due to the strengthening of the US dollar.

    調整後毛利和利潤率年減是由於通貨膨脹對某些原材料、直接人工、運費和間接費用的成本的影響;年比製造負差異的影響,主要是由於我們計劃暫時關閉中國蘇州工廠,因為這與本季度部分時間中國國內市場的生產有關;外幣換算的負面影響,主要是因為美元走強。

  • As compared to our prior outlook, our adjusted gross margin during the second quarter was better than we previously expected, and this was due to the higher-than-anticipated revenue that Dev referred to earlier as well as favorable geographic and product mix.

    與我們先前的預期相比,我們第二季調整後的毛利率優於我們先前的預期,這是由於 Dev 先前提到的收入高於預期以及有利的地域和產品組合。

  • Turning to GAAP operating income and margin. During the second quarter, they were $39.2 million and 13.6%. This compared to $55.6 million and 20.1% in the prior year period. While on an adjusted basis, our Q2-2024 adjusted operating income and margin totaled $74.9 million and 26.1%. This compared to $84.9 million and 30.6% in the prior year period.

    轉向 GAAP 營業收入和利潤率。第二季為 3,920 萬美元,佔 13.6%。相比之下,去年同期成長了 5,560 萬美元,成長了 20.1%。在調整後的基礎上,我們 2024 年第二季調整後的營業收入和利潤率總計 7,490 萬美元,佔 26.1%。相比之下,去年同期成長了 8,490 萬美元,成長了 30.6%。

  • The year-over-year decrease in adjusted operating income and margin is primarily due to the adjusted gross profit changes I just discussed as well as an increase in SG&A costs associated with standing up the organization. These additional costs were somewhat offset by a reduction in year-over-year R&D expense, primarily due to an upfront payment made in the prior year period in connection with the Tidepool algorithm collaboration agreement as well as a reduction in TSA expenses. The adjusted operating Income and margin performance during Q2 was better than we previously expected, primarily due to the overachievement of the gross margin line, coupled with the timing of R&D spending within the quarter.

    調整後營業收入和利潤率的同比下降主要是由於我剛才討論的調整後毛利變化以及與組織建立相關的銷售、管理和行政費用的增加。這些額外成本在一定程度上被同比研發費用的減少所抵消,這主要是由於上一年期間與 Tidepool 演算法合作協議相關的預付款以及 TSA 費用的減少。第二季調整後的營業收入和利潤率表現優於我們先前的預期,這主要是由於毛利率線的超額完成,以及本季研發支出的時機。

  • Turning to the bottom line. GAAP net income and earnings per diluted share were $28.9 million and $0.50 during the second quarter of fiscal 2024, which compared to $14 million and $0.24 in the prior year period. While on an adjusted basis, net income and earnings per share were $38.9 million and $0.67 during the second quarter of fiscal 2024. This compared to $43.3 million and $0.75 in the prior year period.

    轉向底線。2024 財年第二季的 GAAP 淨利和稀釋每股收益分別為 2,890 萬美元和 0.50 美元,而去年同期為 1,400 萬美元和 0.24 美元。調整後的 2024 財年第二季淨利和每股盈餘分別為 3,890 萬美元和 0.67 美元。相比之下,去年同期為 4,330 萬美元,0.75 美元。

  • The decrease In year-over-year adjusted net income and diluted earnings per share is primarily due to the adjusted operating profit drivers I just discussed, as well as an increase in year-over-year interest expense associated with the rise in SOFR and the impact that had on our variable interest rate debt. This was somewhat offset by a reduction in our adjusted tax rate from approximately 25% in Q2 of 2023 to approximately 17.9% in Q2 of 2024.

    調整後淨利潤和稀釋每股收益同比下降主要是由於我剛才討論的調整後營業利潤驅動因素,以及與 SOFR 和這對我們的可變利率債務產生了影響。我們調整後的稅率從 2023 年第二季的約 25% 降至 2024 年第二季的約 17.9%,在一定程度上抵銷了這一影響。

  • The year-over-year reduction in our adjusted tax rate was expected and was due to certain discrete tax items that occurred during the quarter. For the first six months of 2024, our adjusted tax rate was approximately 22%, which is in line with our annual adjusted tax rate expectations.

    我們的調整後稅率年減是預期的,這是由於本季發生的某些離散稅項所致。2024年前六個月,我們的調整後稅率約為22%,這與我們的年度調整後稅率預期一致。

  • Lastly, from a P&L perspective. For the second quarter of 2024, our adjusted EBITDA and margin totaled approximately $90.8 million and 31.6%. This compared to $96.7 million and 34.9% in the prior year period.

    最後,從損益表的角度來看。2024 年第二季度,我們調整後的 EBITDA 和利潤率總計約為 9,080 萬美元和 31.6%。相比之下,去年同期成長了 9,670 萬美元,成長了 34.9%。

  • Turning to the balance sheet and cash flow. At the end of the second quarter, our cash balance totaled $306.5 million, while our last 12-months net leverage, as defined under our credit facility agreement, stood at approximately 3.8 times. As a reminder, our net leverage covenant requires us to stay below 4.75 times.

    轉向資產負債表和現金流量。截至第二季末,我們的現金餘額總計 3.065 億美元,而我們過去 12 個月的淨槓桿率(根據信貸安排協議定義)約為 3.8 倍。提醒一下,我們的淨槓桿契約要求我們保持在 4.75 倍以下。

  • From a cash flow perspective, our cash balance as of March 31 is approximately $20 million lower than the balance that existed as of September 30, and this is largely attributed to cash that has been used related to separation-related activities, which include product registration and labeling costs; warehousing and distribution setup costs; legal costs associated with patents and trademark work; temporary head count resources within accounting, tax, finance, human resources, regulatory and IT; and onetime business integration and IT-related costs, primarily associated with our global ERP implementations. We estimate that during the first six months of fiscal-year 2024, we used approximately $90 million of cash towards the separation activities.

    從現金流的角度來看,我們截至 3 月 31 日的現金餘額比截至 9 月 30 日的餘額減少了約 2000 萬美元,這主要歸因於與離職相關活動(包括產品註冊)所使用的現金和標籤費用;倉儲和配送設置成本;與專利和商標工作相關的法律費用;會計、稅務、財務、人力資源、監管和 IT 領域的臨時人員資源;一次性業務整合和 IT 相關成本,主要與我們的全球 ERP 實施相關。我們估計,在 2024 財年的前六個月,我們使用了約 9,000 萬美元的現金用於離職活動。

  • As we look forward, we currently estimate that we will end fiscal-year 2024 with a cash balance roughly comparable to the balance that existed at the end of the second quarter. This includes an expectation that for the full year, we will use between approximately $180 million and $190 million of cash towards separation activities. This compares to cash used for separation activities of approximately $145 million during fiscal-year 2023.

    展望未來,我們目前估計 2024 財年結束時,我們的現金餘額將與第二季末的餘額大致相當。這包括預計我們將在全年使用約 1.8 億至 1.9 億美元的現金用於離職活動。相較之下,2023 財年用於離職活動的現金約為 1.45 億美元。

  • Given that we expect to be complete with most separation projects by the end of this fiscal year, we would expect to see an improvement in our cash balances in fiscal-year 2025 and beyond, which would allow us additional flexibility in terms of capital allocation, including debt repayment. Additionally, we now show trade receivables globally on our balance sheet given our previously mentioned ERP implementations and the exit of our factoring agreements with BD.

    鑑於我們預計將在本財年年底前完成大多數分離項目,我們預計 2025 財年及以後的現金餘額將有所改善,這將使我們在資本配置方面具有更大的靈活性,包括償還債務。此外,鑑於我們之前提到的 ERP 實施以及與 BD 的保理協議的退出,我們現在在資產負債表上顯示全球範圍內的貿易應收帳款。

  • I’m pleased to report that following the implementation of our ERP system and shared service functionality in November of 2023 within North America, that the cash collections associated with those receivables have continued to trend in a positive direction, and that this has returned to a more typical levels of accounts receivable within North America. This is important as it will allow us to focus our attention on the newly generated accounts receivable that exists within EMEA and Asia, and turning those receivables into cash following our March of 2024 ERP implementations and shared service capabilities in those regions.

    我很高興地報告,繼 2023 年 11 月在北美實施我們的 ERP 系統和共享服務功能後,與這些應收款相關的現金收款繼續呈積極趨勢,並且已恢復到北美地區更典型的應收帳款水平。這很重要,因為這將使我們能夠將注意力集中在歐洲、中東和非洲和亞洲地區新產生的應收帳款上,並在2024 年3 月在這些地區實施ERP 和共享服務能力後將這些應收帳款轉化為現金。

  • That completes my comments on our fiscal Q2 results. Next, I will provide an update on our full-year 2024 financial guidance.

    我對第二財季業績的評論就到此結束。接下來,我將提供 2024 年全年財務指引的最新資訊。

  • Beginning with revenue. Given our performance during the first half of the year, we are tightening our constant currency revenue guidance range as we are now calling for full-year 2024 constant currency revenue to be flat to down 0.5% as compared to 2023. This compares to our prior guidance range, which called for full-year constant currency revenue to be flat to down 2% as compared to the prior year or an increase of approximately 75 basis points at the midpoint.

    從收入開始。鑑於我們上半年的業績,我們正在收緊固定貨幣收入指引範圍,因為我們現在要求 2024 年全年固定貨幣收入與 2023 年相比持平或下降 0.5%。這與我們先前的指導範圍相比,我們先前的指導範圍要求全年固定貨幣收入與上一年相比持平至下降 2%,或中點增加約 75 個基點。

  • The low end of our updated constant currency revenue growth guidance range is driven entirely by year-over-year headwinds associated with reduced contract manufacturing revenue of non-diabetes products as we now expect our underlying core injection diabetes product revenues to be flat compared to a 1% decline assumed in our prior guidance. While the high end of our constant currency revenue range is unchanged as compared to our prior guidance.

    我們更新後的固定貨幣收入成長指引範圍的低端完全是由與非糖尿病產品合約製造收入減少相關的逐年不利因素驅動的,因為我們現在預計我們的基礎核心注射糖尿病產品收入將與去年同期持平。我們先前的指導中假設下降1%。雖然我們的固定貨幣收入範圍的上限與我們先前的指導相比沒有變化。

  • Turning to FX. We are reaffirming our previously provided guidance, which called for a foreign currency to be a headwind of approximately 0.4% versus the prior year. These FX assumptions are based on foreign exchange rates that were in existence during the late April time frame, including a euro to US dollar exchange rate of approximately 1.08. On a combined basis, our updated as reported guidance range calls for revenue to be down between 0.4% and 0.9% as compared to 2023, resulting in an updated revenue guide of between $1.111 billion and $1.116 billion.

    轉向外匯。我們重申先前提供的指導,該指導要求外幣比上年逆風約 0.4%。這些外匯假設是基於 4 月下旬期間存在的外匯匯率,其中歐元兌美元匯率約為 1.08。綜合來看,我們更新後的報告指引範圍要求收入較 2023 年下降 0.4% 至 0.9%,從而導致更新後的收入指引在 11.11 億美元至 11.16 億美元之間。

  • Turning to margins. We are raising the midpoint of our adjusted gross, adjusted operating and adjusted EBITDA margin guidance by 125 basis points each. As we now expect adjusted gross margin of between 64.5% and 65%, adjusted operating margin of between 25.25% and 25.75%, and adjusted EBITDA margin of between 31% and 31.5%.

    轉向邊緣。我們將調整後毛利率、調整後營業額和調整後 EBITDA 利潤率指引的中點分別上調 125 個基點。我們目前預計調整後毛利率在 64.5% 至 65% 之間,調整後營業利潤率在 25.25% 至 25.75% 之間,調整後 EBITDA 利潤率在 31% 至 31.5% 之間。

  • Finally, due to a combination of improved revenue and margin outlook, we are increasing our adjusted earnings per share guidance from a range of between $1.95 and $2.15 to a new range of between $2.20 and $2.30 or an increase at the midpoint of $0.20. Our updated guidance range continues to assume that our annual net interest expense will be approximately $116 million, that our annual adjusted tax rate will be approximately 22%, and that our weighted average diluted shares outstanding will be approximately 58.1 million.

    最後,由於收入和利潤前景的改善,我們將調整後每股收益指引從 1.95 美元至 2.15 美元提高到 2.20 美元至 2.30 美元的新範圍,或增加 0.20 美元的中點。我們更新後的指導範圍繼續假設我們的年度淨利息支出約為 1.16 億美元,我們的年度調整稅率約為 22%,我們的加權平均稀釋後流通股約為 5810 萬股。

  • This completes my prepared remarks. And at this time, I would like to turn the call over to the operator for questions. Operator?

    我準備好的發言到此結束。此時,我想將電話轉給接線生詢問。操作員?

  • Operator

    Operator

  • (Operator Instructions) Travis Steed, Bank of America Securities.

    (操作員指示)Travis Steed,美國銀行證券公司。

  • Unidentified Analyst

    Unidentified Analyst

  • Hi. This is Caroline on for Travis. Thanks for taking the questions. I wanted to start out first with the full-year guidance. It looks like you beat street expectations by about $8.5 million, and then raised the full-year guide by $22 million.

    你好。這是崔維斯的卡洛琳。感謝您提出問題。我想先從全年指導開始。看起來您超出了市場預期約 850 萬美元,然後將全年指導提高了 2200 萬美元。

  • So I'm wondering if you can speak to any one-time impacts in the quarter? I believe you said previously that about $15 million was pulled forward, and then contract manufacturing was a 40 bps headwind. So I just wanted to confirm that I got that right, see if there's anything else that we should be taking into consideration for the full-year guidance here. Thanks. And then, I have one follow up.

    所以我想知道您是否可以談談本季的任何一次性影響?我相信你之前說過大約 1500 萬美元被提前,然後合約製造是 40 個基點的逆風。所以我只是想確認我的說法是正確的,看看我們在全年指導中是否還應該考慮其他任何事情。謝謝。然後,我有一個跟進。

  • Jacob Elguicze - Chief Financial Officer, Senior Vice President

    Jacob Elguicze - Chief Financial Officer, Senior Vice President

  • Yeah. Thanks, Caroline. I think you might have had the numbers just transposed. We did very well in the quarter. I'm not necessarily going to refer to consensus expectations. But I think we did beat our own internal expectations by about $22 million in the quarter, and we did refer to about $16 million of that being attributed to timing.

    是的。謝謝,卡洛琳。我想你可能已經把剛才的數字調換了。我們本季表現非常好。我不一定要提及共識期望。但我認為本季我們確實超出了內部預期約 2,200 萬美元,我們確實提到其中約 1,600 萬美元歸因於時間安排。

  • So simply in advance of the ERP implementations, we saw customers order some additional product in our international markets, probably by about $10 million in the quarter. And then, in the US, in advance of our normal April 1 price increase, we saw some additional volumes in the US, and we estimate that to be a timing benefit of about $6 million in the quarter.

    因此,就在 ERP 實施之前,我們看到客戶在我們的國際市場上訂購了一些額外產品,本季可能訂購了約 1000 萬美元。然後,在美國,在 4 月 1 日正常漲價之前,我們看到美國銷量增加,我們估計本季的時間效益約為 600 萬美元。

  • So $16 million, we would affect to reverse from Q2 into Q3. But then, the underlying business did quite well, did about $6 million better than what we had previously internally expected, largely due to the US.

    因此,1600 萬美元,我們會影響從第二季逆轉到第三季。但隨後,基礎業務表現相當不錯,比我們之前的內部預期高出約 600 萬美元,主要歸功於美國業務。

  • In relation to the full year, we're raising our midpoint of the guidance range on the top line by about $8.5 million at midpoint, about $6 million of which we think occurred in the US in the second quarter. But obviously, we're affecting commissional favorability in the half of the year in relation to the prior guide. So a very strong quarter, I think for us, particularly when you think about all the work that had to occur related to the ERP implementations.

    就全年而言,我們將營收指引範圍的中點提高了約 850 萬美元,其中約 600 萬美元我們認為第二季發生在美國。但顯然,相對於先前的指南,我們會影響今年上半年的佣金好感度。我認為對我們來說,這是一個非常強勁的季度,特別是當你考慮到與 ERP 實施相關的所有工作時。

  • Unidentified Analyst

    Unidentified Analyst

  • Thank you. Yes, I had that transposed. I appreciate that correction there. And then, second question, can you provide an update on your plans for entering the GLP-1 market with pen needles. I know recently, it looks like Lilly got an approval for a Kwikpen. I'm not sure if there's anything more you can say there just again on your outlook for entering the GLP-1 market. Thank you.

    謝謝。是的,我已經把它換位了。我很欣賞那裡的糾正。然後,第二個問題,您能否提供有關筆式針頭進入 GLP-1 市場的計劃的最新資訊。我知道最近,Lilly 似乎獲得了 Kwikpen 的批准。對於進入 GLP-1 市場的前景,我不確定您是否還有什麼可以再說的。謝謝。

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Yeah, Caroline. Hi. This is Dev. I'll take that. Yeah, as you correctly pointed out, Lilly did get approval for the Kwikpen. Kwikpen, as you know, is the same pen that's used for insulin delivery. And pen is used for insulin delivery, typically use our pen needles in most markets around the world. We do have leading share.

    是的,卡洛琳。你好。這是德夫。我會接受的。是的,正如您正確指出的那樣,禮來公司確實獲得了 Kwikpen 的批准。如您所知,Kwikpen 與用於胰島素輸送的筆相同。筆用於胰島素輸送,在全球大多數市場通常使用我們的筆針。我們確實擁有領先的份額。

  • Our expectation is as GLP presentation forms continue to evolve and more and more of them become available in pens, certainly, our pen needles can be used with it. We continue to have discussions with other potential entrants into the GLP-1 space, including generics now. Admittedly, they are years away. But our hypothesis is as more GLP-1 players enter the market, it's likely that many of them will present their version of the GLP-1 in a multi-dose pen form and our pen needles will be applicable for it.

    我們的期望是,隨著 GLP 演示形式的不斷發展,越來越多的形式可以用筆使用,當然,我們的筆針也可以與之一起使用。我們繼續與 GLP-1 領域的其他潛在進入者進行討論,包括現在的仿製藥。誠然,距離他們還有好幾年的時間。但我們的假設是,隨著越來越多的GLP-1 參與者進入市場,他們中的許多人可能會以多劑量筆的形式展示他們的GLP-1 版本,而我們的筆針將適用於它。

  • Now, certainly, as these manufacturers work to expand capacity, in some cases, they're also using vials. And with the regulatory approval, our syringes can be used as well. So as more and more GLPs enter the market, more pens will become available. And certainly, our pen needles can be used with those pens.

    當然,現在,隨著這些製造商努力擴大產能,在某些情況下,他們也會使用小瓶。經監管部門批准,我們的注射器也可以使用。因此,隨著越來越多的 GLP 進入市場,將會有更多的筆可供使用。當然,我們的筆針可以與這些筆一起使用。

  • Unidentified Analyst

    Unidentified Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Marie Thibault, BTIG.

    瑪麗蒂博,BTIG。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Hi. Good morning. Thanks for taking the questions, and congrats on a very nice quarter here. I'll leave the guidance questions to others. But I did want to ask a little bit more about accounts receivables. I know, with Embecta now responsible for collecting some of those receivables, the plan was to work some of this down in fiscal '24. I know the ERP transition is still happening. Just wanted to try to understand why that receivables number ticked up a little bit, and how we can expect that to look for the rest of the fiscal year?

    你好。早安.感謝您提出問題,並祝賀您度過了一個非常愉快的季度。我將把指導問題留給其他人。但我確實想多問一些有關應收帳款的問題。我知道,Embecta 現在負責收取其中一些應收帳款,計劃是在 24 財年解決其中的一些問題。我知道 ERP 轉型仍在進行中。只是想嘗試了解為什麼應收帳款數量略有上升,以及我們如何預期該情況會在本財年剩餘時間內出現?

  • Jacob Elguicze - Chief Financial Officer, Senior Vice President

    Jacob Elguicze - Chief Financial Officer, Senior Vice President

  • Yeah. So Marie, the change in the receivable balance from, let's call it, fiscal year-end 9/30/2023 to where we are now entirely has to do with the fact that went live with our ERP implementations, and the factoring agreements that we had previously in place with BD where they would essentially factor those receivables on our behalf went away. And now, we're responsible. All those receivables now appear on our balance sheet.

    是的。因此,瑪麗,應收帳款餘額從 2023 年 9 月 30 日財年結束到現在的變化完全與我們的 ERP 實施以及我們所簽訂的保理協議有關。上會代表我們對這些應收帳款進行保理。現在,我們有責任了。所有這些應收帳款現在都出現在我們的資產負債表上。

  • And at this point, all of the factoring agreements have now ceased. So the receivables that you see on our balance sheet are 100% representative of what the AR balance is for Embecta look like. There's no additional receivables that we would need to put on to our balance sheet.

    至此,所有保理協議均已終止。因此,您在我們的資產負債表上看到的應收帳款 100% 代表了 Emecta 的應收帳款餘額。我們不需要將額外的應收帳款加到資產負債表中。

  • From the last quarter, from Q1 or fiscal Q1 to where we are right now, we did see an increase in the AR, again, entirely due to now our EMEA and Asia receivables coming on to our balance sheet as a result of those ERP implementations. And I think the way that you should think about this moving forward, maybe just from like a total cash standpoint, I think we said in our prepared remarks that we would expect our overall ending cash balance for fiscal 2024 to be very close to where it is right now from a Q2 standpoint, so somewhere around that kind of $300 million-ish mark. That's down about $20 million from where we were at year end. And again, that entirely has to do with cash used for separation and stand-up activities.

    從上個季度,從第一季或第一財季到我們現在的情況,我們確實看到AR 有所增加,這完全是由於ERP 實施導致我們的EMEA 和亞洲應收帳款進入了我們的資產負債表。我認為您應該如何考慮這一進展,也許只是從總現金的角度來看,我認為我們在準備好的評論中說過,我們預計 2024 財年的最終現金餘額總體將非常接近從第二季度的角度來看,現在大約是3 億美元左右。這比年底減少了約 2000 萬美元。再說一次,這完全與用於分離和站立活動的現金有關。

  • We estimate that we're going to use somewhere between $180 million and $190 million of cash this year related to separation. That comes on top of using about $145 million in the prior year. And I think that's really one of the things that is distorting, if you will, the real free cash flow capabilities of the company. And I think as we move into fiscal 2025 and beyond, now that we're almost past all of the separation work, you're really going to see the true free cash flow potential of this organization.

    我們估計,今年我們將使用 1.8 億至 1.9 億美元的與離職相關的現金。在此基礎上,上一年使用了約 1.45 億美元。我認為這確實是扭曲公司真正自由現金流能力的因素之一。我認為,隨著我們進入 2025 財年及以後,現在我們幾乎已經完成了所有的分離工作,您真的會看到該組織真正的自由現金流潛力。

  • Marie Thibault - Analyst

    Marie Thibault - Analyst

  • Marie Thibault

    瑪麗蒂博

  • Okay, Jake, that's helpful. And then, I wanted to ask a question a little bit about some of the market dynamics, competitive dynamics. I think near the end of your fiscal second quarter, we saw a competitor sell off and transfer its pen needle and blood glucose meter business to another company. I wanted to hear if you've seen any disruption here now in the existing current quarter? And any thoughts on ability to maybe take some market share or make some efforts in those regions where that competitor was very active? Thanks for taking the questions.

    好的,傑克,這很有幫助。然後,我想問一些有關市場動態、競爭動態的問題。我認為在第二財季末,我們看到一家競爭對手出售並將其筆針和血糖儀業務轉移到另一家公司。我想聽聽您在當前季度是否發現任何中斷?對於是否有能力在競爭對手非常活躍的地區佔據一些市場份額或做出一些努力有什麼想法?感謝您提出問題。

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Yeah. Hi, Marie. Good morning. So we haven't seen any disruption really from our perspective with respect to the transaction you were referring to. And certainly, with respect to our sales force focus on ensuring that we present our products with as much vigor as possible and certainly continue to gain share, I mean that will continue.

    是的。嗨,瑪麗。早安.因此,從我們的角度來看,對於您所指的交易,我們並沒有真正看到任何中斷。當然,就我們的銷售人員而言,我們的重點是確保我們盡可能充滿活力地展示我們的產品,並肯定會繼續獲得份額,我的意思是這種情況將會持續下去。

  • We find that -- we certainly think that our products that compete with these competitors' products are very well positioned. We have demonstrated continuity of supply, notably even through the ERP transitions that we referred to. And so, we'll continue to make efforts in that area, but I'll leave it at that.

    我們發現—我們當然認為我們的產品在與這些競爭對手的產品競爭時處於非常有利的地位。我們已經證明了供應的連續性,尤其是透過我們提到的 ERP 過渡。因此,我們將繼續在該領域做出努力,但我就到此為止。

  • Operator

    Operator

  • Kallum Titchmarsh, Morgan Stanley.

    卡勒姆·蒂奇馬什,摩根士丹利。

  • Kallum Titchmarsh - Analyst

    Kallum Titchmarsh - Analyst

  • Hey. Good morning, guys. Thanks for taking the question. On the patch pump program, I know we're still in the early stages here. But now, you've had some more time to consider the implications. I'm wondering when you expect the costs to begin ramping to support the commercial infrastructure behind the project? It seems, just eyeballing consensus, that there's about flattish OpEx across the next few years. So just curious on how we should be thinking about midterm changes there? And then, I have one follow up. Thanks.

    嘿。早上好傢伙。感謝您提出問題。關於補丁泵計劃,我知道我們仍處於早期階段。但現在,您有更多時間來考慮其影響。我想知道您預計何時開始增加支持該項目背後的商業基礎設施的成本?就目前的共識而言,未來幾年的營運支出似乎將持平。所以只是好奇我們該如何考慮中期變化?然後,我有一個跟進。謝謝。

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Yeah. Hi, Kallum. So look, our focus right now is just undergoing -- completing the FDA review. We submitted our 510(k) in late calendar 2023, as you know. And so, I certainly don't want to comment on either the outcome or the timing of when we would expect a decision from the FDA. And candidly, our focus right now is just completing that review and completing the remaining separation work and closing out FY2024.

    是的。嗨,卡勒姆。所以看,我們現在的重點是完成 FDA 審查。如您所知,我們在 2023 年末提交了 510(k)。因此,我當然不想評論結果或我們期望 FDA 做出決定的時間。坦白說,我們現在的重點只是完成審查並完成剩餘的分離工作並結束 2024 財年。

  • So I'll refrain from talking about '25 expenses and beyond. But certainly, we are considering that as we get closer and we get more and more definitive decisions from the FDA, we are thinking about a potential Investor Day event or a call to better provide our thoughts on FY25 and beyond, particularly as it respect -- as it relates to the patch pump.

    所以我不會談論'25 及以後的費用。但當然,我們正在考慮,隨著我們越來越接近,我們從FDA 得到越來越多的明確決定,我們正在考慮潛在的投資者日活動或呼籲更好地提供我們對25 財年及以後的想法,特別是因為它尊重 - - 因為它與貼片泵有關。

  • Kallum Titchmarsh - Analyst

    Kallum Titchmarsh - Analyst

  • That's fair enough. Thanks. And then, I know we've got to keep our eyes on leverage, but any change in your appetite for M&A?

    這很公平。謝謝。然後,我知道我們必須密切注意槓桿,但是您對併購的興趣有什麼變化嗎?

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • I think leverage is front and center of our minds here. Jake referred to the fact that we certainly expect our free cash to improve in '25 and beyond. And we are going to be thinking pretty strongly about debt and debt pay down as well.

    我認為槓桿是我們最關心的問題。傑克提到,我們當然希望我們的自由現金在 25 年及以後有所改善。我們也將認真考慮債務和債務償還問題。

  • So again, this is something that we will update the investment community on once we've closed out 2024 and finished up the rest of the separation projects. We certainly expect AR to have normalized. And we'll just have a better sense of the free cash that will be available to the company and talk about our capital allocation priorities going forward from there.

    再次強調,一旦 2024 年結束並完成其餘的分離項目,我們將向投資界通報最新情況。我們當然期望 AR 能夠正常化。我們將對公司可用的自由現金有更好的了解,並討論我們今後的資本配置優先事項。

  • Jacob Elguicze - Chief Financial Officer, Senior Vice President

    Jacob Elguicze - Chief Financial Officer, Senior Vice President

  • And Kallum, I think on prior calls, we referred to wanting to keep a larger cash balance on hand as we went through some of these ERP implementations in case something went wrong. Thankfully, everything has gone very, very well. I think the team has done a tremendous job as far as all of that is concerned. And I think that, as we go into the second half of the year and certainly into 2025, that's just going to provide us with a lot more flexibility in order to potentially pay down more material amounts of debt in addition to what we have been doing so far, which is really just paying off the 1% amortization each year for the term loan base.

    Kallum,我想在之前的電話會議中,我們提到在實施一些 ERP 實施過程中希望手頭保留更多的現金餘額,以防出現問題。值得慶幸的是,一切都進行得非常非常順利。我認為就所有這些而言,團隊做得非常出色。我認為,隨著我們進入今年下半年,當然還有 2025 年,這將為我們提供更大的靈活性,以便在我們一直在做的事情之外還清​​更多的實質債務。 ,這實際上只是還清每年1% 的定期貸款基礎攤還。

  • Kallum Titchmarsh - Analyst

    Kallum Titchmarsh - Analyst

  • Great. Thanks, guys.

    偉大的。多謝你們。

  • Operator

    Operator

  • (Operator Instructions) Ryan Schiller, Wolfe Research, LLC.

    (操作員說明)Ryan Schiller,Wolfe Research, LLC。

  • Ryan Schiller - Analyst

    Ryan Schiller - Analyst

  • Hey. Good morning. This is Ryan Schiller on for Mike Polark. Thank you for taking the question. I wanted to follow up on the patch pump. It seems to be a product that, if all goes according to plan, could really drive revenue growth. So what changes need to be made to the Tidepool pipeline algo to fit it to type 2? Can you give us your latest expectation on timing to get this to the FDA?

    嘿。早安.我是瑞安·席勒 (Ryan Schiller) 為邁克·波拉克 (Mike Polark) 發言。感謝您提出問題。我想跟進補丁泵。如果一切按計劃進行,這似乎是一個可以真正推動收入成長的產品。那麼,需要對 Tidepool 管道演算法進行哪些更改才能使其適應類型 2?您能否告訴我們您對提交給 FDA 的時間的最新期望?

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Yeah. So look, from a technical aspect, that type of algorithm, Ryan, that you referred to, obviously, was approved for type 1. We are evaluating how it needs to be adapted for type 2. The way we are proceeding with this is our open loop, as you know, is under review with the FDA. We are concurrently working with Tidepool on adapting that algorithm for type 2.

    是的。所以,從技術角度來看,Ryan,您提到的那種演算法顯然已被批准用於類型 1。我們正在評估它需要如何適應類型 2。如您所知,我們正在進行的開環方式正在接受 FDA 的審查。我們同時與 Tidepool 合作,調整該演算法以適應類型 2。

  • And our anticipation is when we are ready, and again, this is something we can talk about after we get clearance, assuming we get clearance for FDA -- from FDA for open loop, we'll certainly talk a little more about the clinical trial that will be required here and the timing of the clinical trial. Because from our perspective, that's a very critical element of having the Tidepool algorithm adapted for type 2 and really tested in-patient use and taking all of the data and then submitting that to the FDA for the eventual clearance of a type 2 closed-loop pump. So more on timing post -- after we finish FY24, and once we have clarity on FDA's decision on the open-loop.

    我們的預期是當我們準備好時,再說一遍,這是我們獲得許可後可以討論的事情,假設我們獲得 FDA 的許可——從 FDA 獲得開環,我們肯定會更多地談論臨床試驗這裡需要的以及臨床試驗的時間。因為從我們的角度來看,這是讓 Tidepool 演算法適應 2 型並真正測試住院使用並獲取所有數據然後將其提交給 FDA 以最終批准 2 型閉環的一個非常關鍵的因素泵。因此,更多關於時間發布的信息——在我們完成 2024 財年之後,一旦我們明確了 FDA 關於開環的決定。

  • Ryan Schiller - Analyst

    Ryan Schiller - Analyst

  • That's helpful. Thank you. And then, one follow up. A lot of the major insulin companies have been looking to get approval and to launch weekly basal insulin. How are you guys thinking about this? And what gives you the confidence that Embecta will be able to continue to grow and start to scale up in major geographies?

    這很有幫助。謝謝。然後,進行一項跟進。許多主要胰島素公司一直在尋求批准並推出每週基礎胰島素。你們怎麼看待這個問題?是什麼讓您對 Embecta 能夠繼續發展並開始在主要地區擴大規模充滿信心?

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Yeah, Ryan. So certainly, weekly insulin is something we are watching very closely as well. I think one form of weekly insulin, certainly folks are expecting will get approved in Europe in the coming months.

    是的,瑞安。因此,我們當然也在密切關注每週胰島素的情況。我認為人們肯定期望一種形式的每週胰島素將在未來幾個月內在歐洲獲得批准。

  • From what we understand right now, and clearly, it's not widely available in most geographies, but it will be in a pen form. It won't be packaged with a pen needle, or at least that's what indications seem to be. And as I mentioned before, if it's a pen, quite possibly, our pen needles can be used with it.

    根據我們目前的了解,顯然,它在大多數地區並未廣泛使用,但它將以筆的形式出現。它不會與筆針一起包裝,或至少看起來是這樣。正如我之前提到的,如果它是一支筆,很可能我們的筆針可以與它一起使用。

  • Some of the factors that need to be considered when you think about the adoption of weekly insulin is obviously cost, right? Insulin, regular insulin costs have come down dramatically over the last few years. And so there's going to be needing to be a trade off across cost and efficacy, if you will, is there increased efficacy with weekly insulin versus daily insulin. Promotional focus will matter where the pharma and biopharma companies decide to spend their selling dollars, will it be on GLP-1s or weekly insulin.

    當您考慮採用每週胰島素時,需要考慮的一些因素顯然是成本,對嗎?胰島素,常規胰島素的成本在過去幾年急劇下降。因此,如果願意的話,就需要在成本和功效之間進行權衡,每週胰島素與每日胰島素相比是否會提高功效。製藥和生物製藥公司決定將銷售資金花在哪裡,促銷重點將很重要,是花在 GLP-1 還是每週胰島素。

  • A lot of the basal patients are seen by primary care physicians who may be reluctant to prescribe weekly insulin. Because obviously, dosing of insulin is tricky. And so, they will be maybe, potentially concerned with potentially higher hypoglycemia. I believe in type 1, there is the greater potential for hypoglycemia in type 2, but the fear might remain. People that are using multiple daily injections of insulin, they might just want to stay because they take multiple daily injections every day anyway.

    許多基礎患者由初級保健醫生看診,他們可能不願意每週開胰島素處方。因為顯然,胰島素的劑量很棘手。因此,他們可能會擔心潛在的高血糖。我相信第 1 型,2 型發生低血糖的可能性更大,但恐懼可能仍然存在。每天多次注射胰島素的人可能只想留下來,因為無論如何他們每天都會注射多次。

  • So our thinking is that to the extent that weekly insulin gets adopted, it might likely be with new basal patients rather than folks switching over. But look, I mean, these are all hypothesis, right? I mean we don't have enough data of real use in patients to be able to accurately or perhaps more precisely determine the impact of weekly insulin on us. And so, it's going to take time to figure all of it out. But some of the factors that I laid out here, Ryan, are those that we are considering certainly as things to watch as weekly insulin gets introduced into the world.

    因此,我們的想法是,在採用每週胰島素的情況下,可能是新的基礎患者而不是轉換的人。但你看,我的意思是,這些都是假設,對吧?我的意思是,我們沒有足夠的患者實際使用數據,無法準確或更精確地確定每週胰島素對我們的影響。因此,解決所有問題需要時間。但瑞安,我在這裡列出的一些因素是我們在每週胰島素引入世界時肯定要考慮的因素。

  • Operator

    Operator

  • Thank you. I'm currently showing no further questions at this time. I'd like to hand the call back over to Dev Kurdikar for closing remarks.

    謝謝。我目前沒有提出任何進一步的問題。我想將電話轉回德夫庫迪卡 (Dev Kurdikar) 作結束語。

  • Devdatt Kurdikar - President, Chief Executive Officer, Director

    Devdatt Kurdikar - President, Chief Executive Officer, Director

  • Thank you, Shannon. As we wrap up the call, I want to extend my heartfelt appreciation to all of my colleagues at Embecta across the globe.

    謝謝你,香農。在我們結束電話會議時,我想向全球 Embecta 的所有同事表示衷心的感謝。

  • In the last two years since our spin off, our team has worked nonstop on executing our strategic priorities, including major separation-related programs while never wavering from our mission of developing and providing solutions that make life better for people living with diabetes.

    自分拆以來的過去兩年裡,我們的團隊一直在不間斷地執行我們的戰略重點,包括與離職相關的重大計劃,同時從未動搖過我們開發和提供解決方案的使命,讓糖尿病患者的生活變得更好。

  • Thank you all for attending the call and for your interest in our business.

    感謝大家參加電話會議以及對我們業務的興趣。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for your participation. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。