Organon & Co (OGN) 2025 Q3 法說會逐字稿

Hello, and welcome to the Organon Third Quarter 2025 Earnings Call and Webcast. [Operator Instructions] I would now like to turn the conference over to Jennifer Halchak, Vice President, Investor Relations. You may begin.

大家好，歡迎參加 Organon 2025 年第三季財報電話會議和網路直播。[操作員指示] 現在我將會議交給投資者關係副總裁珍妮佛·哈爾查克。你可以開始了。

Thank you, operator, and good morning, everyone. Today, we will be referencing a presentation that is visible during this call for those of you on our webcast. This presentation will also be available following this call on the Events & Presentations section of our Organon Investor Relations website. Please reference Slides 2 and 3 for some brief reminders.

謝謝接線員，大家早安。今天，我們將參考一份演示文稿，透過網路直播觀看本次電話會議的各位可以查看該簡報。本次電話會議結束後，您也可以在 Organon 投資者關係網站的「活動與簡報」版塊查看本次簡報。請參考投影片 2 和 3 中的一些簡短回顧。

I would like to caution listeners that certain information discussed by management during this call will include forward-looking statements. Forward-looking statements can be identified because they do not relate strictly to historical or current facts and use words such as potential, should, will, continue, expects, believes, future, estimates, believes and other words of similar meaning.

我想提醒各位聽眾，管理階層在本次電話會議中討論的某些資訊將包含前瞻性陳述。前瞻性陳述可以透過以下方式識別：它們不完全與歷史或當前事實相關，並且使用諸如潛在、應該、將、繼續、預期、相信、未來、估計、相信等詞語以及其他類似含義的詞語。

Actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the SEC. This includes our most recent Form K and Forms 10-Q and those amended forms that we filed earlier this morning, as well as our October 27, 2025 Form 8-K. These statements are based on information as of today, November 10, 2025. And except as required by law, Organon undertakes no obligation to update or revise any of these forward-looking statements.

由於公司業務存在風險和不確定性，實際結果可能與前瞻性聲明中所述或暗示的結果有重大差異，這些風險和不確定性已在公司向美國證券交易委員會提交的文件中進行了討論。這包括我們最新的 K 表格和 10-Q 表格以及我們今天早上早些時候提交的修訂表格，以及我們 2025 年 10 月 27 日的 8-K 表格。這些聲明是基於截至2025年11月10日的資訊。除法律要求外，Organon 不承擔更新或修改任何前瞻性聲明的義務。

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. Descriptions of these measures and reconciliations to the comparable GAAP measures are included in today's earnings press release and conference call presentation, both of which are available on our Investor Relations website and have been furnished to the SEC on a current report on Form 8-K.

此外，我們將在本次電話會議上討論一些非GAAP財務指標，這些指標應被視為依照GAAP編制的財務指標的補充，而不是替代方案。這些措施的描述以及與可比較 GAAP 措施的調節表包含在今天的盈利新聞稿和電話會議演示文稿中，這兩份文件均可在我們的投資者關係網站上找到，並且已通過 8-K 表格的最新報告提交給美國證券交易委員會。

I note that while our full year 2025 guidance measures other than revenue are provided on a non-GAAP basis, Organon does not provide GAAP financial measures on a forward-looking basis, because we cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of those legal proceedings, unusual gains, and losses, the occurrence of matters creating GAAP tax impacts and acquisition-related expenses.

我注意到，雖然我們2025年全年除收入以外的其他業績指引指標均以非GAAP準則提供，但Organon公司並未以前瞻性方式提供GAAP財務指標，因為我們無法在不付出不合理努力的情況下，合理確定地預測這些法律訴訟的最終結果、異常和損失、產生GAAP稅務影響的事項的發生收益以及與與收購相關的費用。

These items are uncertain, depend on various factors and could be material to our results computed in accordance with GAAP. On the call today, [Carry], Joe and Matt will address certain information about our internal investigation. Additional information about the investigation is available in our SEC filings. Beyond the statements today and the information in our filings, we will not be taking questions on the investigation.

這些項目存在不確定性，取決於多種因素，並且可能對我們按照公認會計原則計算的結果產生重大影響。在今天的電話會議上，[Carry]、Joe 和 Matt 將介紹我們內部調查的某些資訊。有關調查的更多信息，請參閱我們向美國證券交易委員會提交的文件。除了今天發布的聲明和我們提交的文件中包含的資訊外，我們將不再接受有關調查的問題。

Today, the team will discuss our business, third quarter results and guidance, and they will take questions on those matters after their prepared remarks. And now I'll turn the call over to [ Carry ].

今天，團隊將討論我們的業務、第三季業績和展望，並在準備好的發言後回答有關這些問題的問題。現在我將把電話交給…[ 攜帶 ]。

Thank you, Jen. Hello, everyone, and thank you all for joining us today. I've had the privilege of serving as Board Chair of Organon since 2021. I've been in the [pharma] industry now over 4 decades. And about half of those years were spent in global leadership roles, which required navigating businesses through periods of transformation and growth. A good part of that experience was leading shearing [flow] global pharmaceuticals until the merger with Merck.

謝謝你，珍。大家好，感謝各位今天收看。自 2021 年以來，我有幸擔任 Organon 的董事會主席。我在製藥業工作已經超過40年了。其中大約一半的時間是在全球領導職位上度過的，這需要帶領企業度過轉型和成長時期。那段經歷的大部分時間都花在了領導全球製藥業務的剪切[流程]上，直到與默克合併。

So I have a deep understanding of many of our products and markets here at Organon. Since Organon's inception, our mission has been to deliver impactful medicines and solutions for a healthier every day. there is a shared passion at Organon to advance the complete health of women at all stages of her life, and that's what drew me to Organon from the beginning.

因此，我對歐加農的許多產品和市場都有著深刻的了解。自歐加農成立以來，我們的使命始終是提供有效的藥物和解決方案，讓人們擁有更健康的每一天。歐加農全體員工都懷著共同的熱情，致力於提升女性在人生各個階段的全面健康，而這正是我最初被歐加農吸引的原因。

While we focus on women's health, we also have a diverse portfolio of Biosimilars and Established brands that are important in markets around the world. I'm here today because I have assumed a new role at Organon as Executive Chair. Following the Board's investigation into the company's improper sales practices with two distributors with respect to US sales of Nexplanon. I will be supporting Joe Morrissey, who I will speak about in a minute as our interim CEO.

雖然我們專注於女性健康，但我們也擁有多元化的生物相似藥和成熟品牌產品組合，這些產品在世界各地的市場都非常重要。我今天來到這裡，是因為我已就任 Organon 的執行主席一職。在董事會調查該公司與兩家經銷商就 Nexplanon 在美國的銷售有不當銷售行為後。我將支持喬·莫里西擔任我們的臨時首席執行官，稍後我會詳細介紹他。

The Board has formed a search committee and will be conducting a search for our permanent CEO. In this role, my focus will be on working closely with our leadership team to ensure that we align our resources to our highest priorities and drive operational performance across the portfolio. I will be deeply engaged in monitoring progress, addressing challenges quickly and ensuring that every part of the business is working towards our shared goals.

董事會已成立遴選委員會，並將著手尋找我們的正式執行長。在這個職位上，我的重點是與我們的領導團隊緊密合作，確保我們將資源集中用於最重要的事項，並推動整個投資組合的營運績效。我將密切關注進展情況，迅速應對挑戰，並確保公司的每個部門都朝著我們的共同目標努力。

The independent internal investigation relating to the company's Nexplanon sales to wholesalers in the US is complete. And our remediation efforts are underway, including enhanced control, certain personnel actions, additional training and expanded written procedures.

針對該公司向美國批發商銷售 Nexplanon 的獨立內部調查已經完成。我們正在採取補救措施，包括加強管控、採取某些人事行動、提供額外培訓和擴大書面程序。

The company's wholesaler sales practices identified through this investigation have ceased. And we have new leadership at the company and in our US commercial sales area to ensure this does not happen again. The Board and I are confident that Joe is the right person to assume the role of Interim CEO of Organon and to oversee the remediation measures. He brings integrity, a strong focus on operational excellence and a deep commitment to executing our strategy.

經調查發現，該公司已停止批發銷售行為。我們公司和美國商業銷售部門都已任命了新的領導層，以確保此類事件不再發生。董事會和我相信，喬是擔任 Organon 臨時執行長並監督補救措施的合適人選。他為人正直，高度重視卓越運營，並堅定致力於執行我們的策略。

Joe came to Organon from Merck, where he spent more than 30 years. At Organon, he was already a member of the executive leadership team and has served as Head of Global Manufacturing and Supply Chain since Organon's inception, leading the company's efforts to deliver medicines and solutions around the world. We appreciate Joe agreeing to step in at this critical juncture.

喬從默克公司來到歐加農公司，他在默克公司工作了 30 多年。在 Organon 公司，他已經是執行領導團隊的成員，並且自 Organon 成立以來一直擔任全球製造和供應鏈負責人，領導公司在全球範圍內提供藥品和解決方案。我們感謝喬同意在這個關鍵時刻挺身而出。

Importantly, I want to stress that our drive for operational excellence and meeting our goals to move our company forward into the future remains unchanged. With that said, I'll hand it over to Joe so that he can talk a bit about his and Organon strategic priorities.

重要的是，我想強調，我們追求卓越營運和實現目標，推動公司走向未來的決心始終不變。接下來，我將把發言權交給喬，讓他談談他和歐加農公司的策略重點。

Thank you, [Terry]. I appreciate the introduction and the opportunity to speak with everyone today. As [ Carey ] mentioned, I spent more than 3 decades at Merck, where I led a number of manufacturing businesses, as well as corporate strategy. That experience combined with my deep understanding of our products, our markets and our supply chains made joining Organon a natural step as I was excited to build something meaningful from the ground up, leveraging our strong history.

謝謝你，[特里]感謝各位的引薦，也感謝今天給我這個與大家交流的機會。正如 [凱裡] 所提到的，我在默克公司工作了 30 多年，期間我領導過多個製造業務部門以及公司策略部門。這段經歷，加上我對我們產品、市場和供應鏈的深刻了解，使我加入 Organon 成為順理成章的事情，因為我很高興能夠利用我們強大的歷史，從零開始打造一些有意義的東西。

We have faced many challenges in these first 4.5 years, but we have a resilient and capable global team. Our diverse product portfolio and footprint help us to generate meaningful revenue and deliver real value to patients and communities around the world.

在過去的4.5年裡，我們面臨了許多挑戰，但我們擁有一支韌性十足、能力卓越的全球團隊。我們多元化的產品組合和廣泛的業務覆蓋有助於我們創造可觀的收入，並為世界各地的患者和社區帶來真正的價值。

As [Carry] has said, our strategic priorities have not changed. Moving forward, we remain focused on executing against these priorities. As we've previously shared, these include deleveraging the business, driving cost savings and achieving revenue growth. I am -- I believe deeply in Organon's mission, our values and our people around the world. I'm fully committed to helping Organon succeed. And with that, I hand it over to Matt.

正如[Carry]所說，我們的戰略重點並沒有改變。接下來，我們將繼續專注於落實這些優先事項。正如我們之前分享過的，這些目標包括降低企業槓桿率、降低成本和實現收入成長。我——我深深地相信 Organon 的使命、價值觀和我們遍布全球的員工。我全心全意致力於幫助歐加農取得成功。然後，我把它交給了馬特。

Thank you, Joe. Beginning on Slide 4. Third quarter revenue was $1.6 billion and adjusted EBITDA was $518 million, representing an adjusted EBITDA margin of 32.3%. Before I go deeper into a discussion of third quarter results, I'd like to spend a minute walking through some specifics about the company's U.S. wholesaler sales practices, the [carrier] reference.

謝謝你，喬。從第四張投影片開始。第三季營收為 16 億美元，調整後 EBITDA 為 5.18 億美元，調整後 EBITDA 利潤率為 32.3%。在深入討論第三季業績之前，我想花一分鐘時間詳細介紹一下公司在美國的批發商銷售做法，以及[承運商]參考。

It's important that investors understand this issue properly. There is limited revenue impact and no financial restatement is necessary. All revenue was properly recorded in accordance with US GAAP. On Slide 5, you'll see a summary of the revenue impact from these practices for the recent quarterly periods identified by the investigation.

投資者正確理解這個問題至關重要。對收入的影響有限，無需進行財務重述。所有收入均已按照美國通用會計準則正確記錄。在第 5 張投影片中，您將看到調查確定的最近幾季中，這些做法對收入影響的總結。

The revenue that we're highlighting is that of Nexplanon sales to two U.S. wholesalers with specific emphasis on revenue transactions occurring close to quarter end. Certain revenue transactions were advanced or pulled forward into the current quarter in excess of estimated patient demand and/or contractually agreed inventory holding levels.

我們重點關注的是 Nexplanon 向兩家美國批發商的銷售收入，尤其專注於季度末附近的收入交易。某些收入交易提前或提前到本季度，超過了預計的患者需求和/或合約約定的庫存持有水準。

For example, for the third quarter of 2024, on the left-hand side of this chart, the sales practices in question resulted in approximately $5 million of pull-forward revenue from the fourth quarter of that year. In the fourth quarter of 2024, there was approximately $15 million pulled forward from the first quarter of 2025. So the net impact in the fourth quarter of 2024 was $10 million. Importantly, because we're talking about the pull forward of sales, these quarterly numbers are not cumulative.

例如，對於 2024 年第三季（請參閱此圖表左側），所討論的銷售做法導致當年第四季提前產生了約 500 萬美元的收入。2024 年第四季度，約有 1,500 萬美元提前支付，這筆款項原定於 2025 年第一季支付。因此，2024 年第四季的淨影響為 1,000 萬美元。重要的是，因為我們討論的是銷售額的提前成長，所以這些季度數字不是累積的。

Our financial statements have been consistently reflecting the net impact, which is clearly not material to our consolidated revenue. Three other important points to make here. First, revenue recognition in all cases was appropriately recognized in accordance with US GAAP, specifically Section [ASC 60] 6, two, during these periods, product returns were at or below historical levels and three, in every relevant period, the units that were pulled forward occurred late in the third month of that quarter, and were absorbed through patient demand by approximately the end of the first month of the following quarter.

我們的財務報表一直反映出淨影響，這顯然對我們的合併收入並不重大。這裡還有三點要說明。首先，所有情況下的收入確認均按照美國公認會計準則（US GAAP）第 6 節進行了適當確認；其次，在這些期間，產品退貨量處於或低於歷史水平；第三，在每個相關期間，提前交付的單位均發生在該季度第三個月的後期，並在下一個季度第一個月末左右被患者需求消化。

Since this practice has ceased and will not continue in the future, we will see the most significant impact in the fourth quarter of this year because the $17 million pull forward in Q3 2025 will not have an offsetting buy-in in Q4 2025. As a result, the pull-forward dynamic rolls off in the fourth quarter and will be contained within the 2025 fiscal year with no carryover impact to 2026.

由於這種做法已經停止，並且將來也不會繼續，我們將在今年第四季度看到最顯著的影響，因為 2025 年第三季提前支付的 1700 萬美元在 2025 年第四季不會有相應的買入來抵消。因此，提前釋放的動力將在第四季度結束，並將控制在 2025 財年內，不會對 2026 年產生任何影響。

One last point on this topic. In the 8-K filing on October 27, the financial impact of these practices for the relevant periods was described as being less than 1% of consolidated revenue for the full year of 2022 and full year 2024 and less than 2% of consolidated revenue for the relevant quarterly periods. Subsequently, we have completed our testing and detailed reviews, resulting in the more narrow estimates that you see here on Slide 5, which are clearly within the ranges disclosed in the 8-K.

關於這個話題，還有最後一點。在 10 月 27 日提交的 8-K 文件中，這些做法對相關期間的財務影響被描述為：2022 年全年和 2024 年全年合併收入的不到 1%，相關季度期間合併收入的不到 2%。隨後，我們完成了測試和詳細審查，得出了您在幻燈片 5 中看到的更窄的估計值，這些估計值顯然在 8-K 文件中披露的範圍內。

Now moving to a discussion of third quarter 2025 results. To be clear, when I refer to revenue and revenue variances, unless otherwise noted, those references are to revenue recorded in our financial statements without adjusting to back out the pull forward. So let's go franchise by franchise, and then we'll move to a discussion of revenue by driver. So turning to Slide 6.

現在來討論一下2025年第三季的業績。需要明確的是，除非另有說明，當我提到收入和收入差異時，這些指的是我們財務報表中記錄的收入，而沒有進行調整以消除前期影響。那麼，讓我們逐一特許經營店進行分析，然後再討論按司機劃分的收入。接下來請看第6張投影片。

The women's health franchise declined 4% at constant currency in the third quarter of 2025 compared with the third quarter of 2024 with growth in contraceptives Marvelon, Mercilon and NuvaRing, partially offsetting a 9% decline in Nexplanon at constant currency. Global Nexplanon sales in the third quarter were $223 million. In the US, Nexplanon declined 50%, while internationally, the product grew 7% [ex] exchange. The biggest challenge facing Nexplanon this quarter was unfavorable US policy, which emerged in Q2, accelerated in Q3 and had the biggest impact in the budget constrained public segments.

2025 年第三季度，女性健康特許經營業務按固定匯率計算比 2024 年第三季度下降了 4%，其中避孕藥 Marvelon、Mercilon 和 NuvaRing 的增長部分抵消了 Nexplanon 按固定匯率計算下降的 9%。第三季全球 Nexplanon 銷售額為 2.23 億美元。在美國，Nexplanon 銷量下降了 50%，而在國際市場上，該產品銷量增長了 7%（不含匯率）。本季 Nexplanon 面臨的最大挑戰是美國不利的政策，該政策在第二季出現，在第三季加速發展，對預算受限的公共部門造成了最大的影響。

Planned Parenthood and federally qualified health centers, where Nexplanon has a leading market share among long-acting reversible contraceptives. In the second quarter, we cited US policy decisions that impact [ Title 1 ] funding and Planned Parenthood. In the third quarter, formalization of these policies intensified budget and access constraints with the greatest impact being realized in Planned Parenthood. On the commercial side, our Nexplanon business is primarily comprised of integrated delivery networks and to a lesser extent, independent health care clinics.

在計劃生育協會和聯邦認可的醫療中心，Nexplanon 在長效可逆避孕產品中佔據領先的市場份額。第二季度，我們引用了影響[Title 1]資金和計劃生育的美國政策決定。第三季度，這些政策的正式實施加劇了預算和進入的限制，其中對計劃生育協會的影響最大。在商業方面，我們的 Nexplanon 業務主要由綜合醫療服務網絡組成，其次是獨立的醫療診所。

In the independent commercial clinics, we've seen a shift away from both purchasing or buy and bill towards single unit specialty pharmacy fulfillment of these claims, as these small businesses try to preserve cash. This is also largely macro-driven and related to inflationary and economic factors with independent health care clinics are facing. We see these headwinds persisting in the fourth quarter in the US and likely to result in full year US Nexplanon sales that are down mid- to high single digit for the full year. We expect international sales of Nexplanon to grow mid- to high single digits ex-FX this year.

在獨立的商業診所中，我們看到，隨著這些小型企業努力節省現金，他們已經從購買或購買並結算轉向由單一單位的專科藥房完成這些索賠。這在很大程度上也是宏觀因素驅動的，與獨立醫療診所面臨的通貨膨脹和經濟因素有關。我們看到這些不利因素在美國第四季持續存在，並可能導緻美國全年 Nexplanon 銷售額下降中高個位數。我們預計今年 Nexplanon 的國際銷售額（不計匯率因素）將實現中高個位數成長。

Putting that together, that means we expect global Nexplanon sales will be down low single digit in 2025 compared with full year 2024 on an ex-exchange basis. In the fourth quarter, that implies global Nexplanon sales will be down by mid-teens ex exchange compared with the fourth quarter of 2024. The discontinuation of the wholesaler practices I mentioned will likely explain about 2/3 of the year-over-year variance in the fourth quarter. Turning to other components of our women's health business.

綜合來看，這意味著我們預計 2025 年全球 Nexplanon 銷售額將比 2024 年全年（不含匯率）下降個位數百分比。這意味著，與 2024 年第四季相比，第四季全球 Nexplanon 銷售額（不含匯率）將下降 15% 左右。我提到的批發商做法的停止，可能會解釋第四季度同比差異的約 2/3。接下來，我們來看看女性健康業務的其他組成部分。

Our fertility business was flat in the third quarter and up 13% year-to-date, ex-FX. For the full year, we expect high single-digit growth driven by the US, which represents about 40% of our global fertility business, as well as market expansion outside the US. And rounding out women's health.

我們的生育業務第三季持平，今年迄今成長了 13%（不計匯率影響）。預計全年將實現高個位數成長，主要得益於美國市場的成長（美國市場約占我們全球生育業務的 40%）以及美國以外市場的擴張。並完善女性健康。

On November 6, we announced that Organon has entered into a definitive agreement to divest the Jada system for $440 million plus another $25 million contingent on 2026 revenue targets. Since acquiring Jada 4 years ago, the Jada team successfully launched the product in the US, secured approvals across multiple countries and managed design iterations as part of continuous improvement activities all leading to Jada being recognized as the standard of care in postpartum hemorrhage management.

11 月 6 日，我們宣布 Organon 已達成最終協議，將以 4.4 億美元的價格出售 Ja​​da 系統，另加 2500 萬美元，具體金額取決於 2026 年的收入目標。自 4 年前收購 Jada 以來，Jada 團隊已成功在美國推出該產品，並在多個國家獲得批准，並透過持續改進活動管理設計迭代，最終使 Jada 被公認為產後出血管理的標準護理產品。

With this divestiture, Organon can delever faster by applying the proceeds to debt reduction, and put Jada in the hands of a med tech company well positioned to build on our great work and the very successful launch of the product.

透過此次剝離，Organon 可以將所得款項用於減少債務，從而更快地降低槓桿率，並將 Jada 交給一家醫療技術公司，該公司有能力在我們出色的工作和產品非常成功的上市基礎上繼續發展。

Turning now to Biosimilars on Slide 7. Year-to-date performance is largely driven by Hadlima, which is up 63% ex-FX globally through September and continues to rank among the leading Biosimilars in terms of total prescriptions in the U.S. This performance reflects the strong clinical profile of Hadlima, which includes the recent interchangeability approval in the US Hadlima has also benefited from the effectiveness of our low-price strategy as well as expansion into Canada and Puerto Rico.

現在就來看看第 7 張投影片中的生物類似藥。今年迄今的業績主要得益於 Hadlima 的推動，截至 9 月份，Hadlima 全球（不含匯率）股價上漲 63%，並且在美國處方總量方面繼續位居生物相似藥前列。這一業績反映了 Hadlima 強大的臨床表現，其中包括最近在美國獲得的互換性批准。 Hadlima 也受益於我們低價策略的有效性以及在加拿大和波多黎各的擴張。

The third quarter also benefited from an international tender for Ontruzant and to a lesser extent, contribution from our new denosumab biosimilar, which was approved by the FDA and launched in the U.S. in late September and Tofidence, which the company acquired in the second quarter of 2025. Wrapping up the franchise discussion with established brands now on Slide 8. The [camera] revenue in the third quarter was $34 million and $89 million year-to-date.

第三季也受惠於 Ontruzant 的國際招標，以及在較小程度上受益於我們新的地諾單抗生物相似藥（已獲得 FDA 批准，並於 9 月下旬在美國上市）和 Tofidence（公司於 2025 年第二季收購）的貢獻。現在在第 8 張投影片中，我們將結束關於成熟品牌的特許經營討論。第三季[相機]營收為 3,400 萬美元，年初至今為 8,900 萬美元。

Our ongoing focus here remains to differentiate Vtama in the market. We have the largest addressable market with a single product in both indications across all severities. Vtama is notable for its safety profile, powerful skin clearance and rapid effect [on] itch relief. It's once-daily dosing regimen and lack of restrictions on duration of use or percentage of body surface area affected further illustrate Vtama's potential for disease management in adults suffering from plaque psoriasis and adults in children down to 2 years of age with atopic dermatitis.

我們目前的工作重點仍然是使Vtama在市場上脫穎而出。我們擁有最大的潛在市場，單一產品即可滿足所有嚴重程度的兩種適應症需求。Vtama 以其安全性高、能有效清除皮膚污垢、快速緩解瘙癢而聞名。Vtama 每日一次的給藥方案，以及對使用時間長度或受影響體表面積百分比沒有限制，進一步表明 Vtama 在治療成人斑塊狀乾癬和 2 歲以下兒童異位性皮膚炎方面具有潛力。

The launch has had a flatter curve than we expected, but we are further investing behind the brand to effect a more rapid uptake in the atopic dermatitis indication. We still believe this product could get close to $0.5 billion globally at peak, even if our $150 million target for this year is now likely out of reach and closer to $120 million to $130 million.

該產品的上市曲線比我們預期的要平緩，但我們正在加大對該品牌的投入，以期在異位性皮膚炎適應症方面實現更快的市場接受度。我們仍然相信，即使我們今年設定的 1.5 億美元的目標現在可能遙不可及，更接近 1.2 億美元至 1.3 億美元，該產品在全球的峰值銷售額仍可接近 5 億美元。

Elsewhere in Established brands, the third quarter marked the last quarter of significant impact from the LOE of Atozet since we lapped that event in September. Importantly, we saw a continuation of softening in our respiratory business. Performance in the respiratory portfolio was primarily driven by declines in Singulair, resulting from lower demand outside of the US.

在其他知名品牌方面，第三季標誌著自 9 月 Atozet 的 LOE 事件以來，該事件對我們產生重大影響的最後一個季度。重要的是，我們看到呼吸系統業務持續疲軟。呼吸系統產品組合的業績主要受孟魯司特鈉（Singulair）銷售下滑的影響，這是由於美國以外地區的需求下降所致。

The montelukast molecule is losing share to newer respiratory products, especially in pediatrics and is facing mandatory price reductions in Japan and China. Dulera was also down significantly in the quarter, primarily due to increased discount rate pressure in the United States, coupled with temporary supply constraints and the negative impact from the loss of a customer contract early this year. As you know, our respiratory business can be seasonal.

孟魯司特分子正在被更新的呼吸系統產品搶佔市場份額，尤其是在兒科領域，並且在日本和中國面臨強制降價。Dulera 在本季也大幅下滑，主要原因是美國貼現率壓力增加，加上暫時的供應限制以及今年年初失去客戶合約帶來的負面影響。如您所知，我們的呼吸系統業務具有季節性。

And given the historical stability of these offerings at midyear, we believe this business would rebound. Based on Q3 results and current projections for the remainder of the year, we anticipate that erosion in the respiratory business will persist through this year and into next year.

鑑於這些產品在年中時的歷史穩定性，我們相信這項業務將會反彈。根據第三季業績和今年剩餘時間的預測，我們預計呼吸系統業務的下滑趨勢將持續到今年年底甚至明年。

Moving to Slide 9, where we detail the drivers of our 1% as reported revenue increase year-on-year for the third quarter. Starting on the left, loss of exclusivity was about $50 million for the quarter, which primarily reflects the impact of the LOE of Atozet in Europe, which occurred in September 2024. As we lap that LOE, we anticipate a relatively smaller impact in the fourth quarter.

接下來是第 9 張投影片，其中我們詳細介紹了第三季報告營收年增 1% 的驅動因素。從左側開始，本季獨家經營權的損失約為 5,000 萬美元，這主要反映了 Atozet 在歐洲的獨家經營權終止的影響，該終止發生在 2024 年 9 月。隨著我們完成該支出，我們預期第四季的影響相對較小。

Year-to-date, we're tracking at the high end of the $170 million to $190 million range we provided last quarter. And so we now estimate LOE impact to be about $200 million for the full year 2025. [ VBP ] in China was de minimis in the third quarter and year-to-date. We now expect Fosamax inclusion in Round 11 to be an early 2026 event, so we expect very minimal impact from [ DBP ] in 2025, less than our previous estimate of $30 million to $50 million. There was an approximate $30 million impact from price for the third quarter or about 1.9%.

今年迄今為止，我們的業績正處於上季預測的 1.7 億美元至 1.9 億美元區間的高端。因此，我們現在估計 2025 年全年 LOE 影響約為 2 億美元。 [VBP] 在中國第三季和年初至今的影響微乎其微。我們現在預計福善美（Fosamax）將在 2026 年初被納入第 11 輪審批，因此我們預計 [DBP] 在 2025 年的影響非常小，低於我們之前估計的 3000 萬美元至 5000 萬美元。第三季價格波動對業績的影響約 3,000 萬美元，影響幅度約 1.9%。

That was mainly driven by the mandatory pricing revisions in respiratory that I mentioned, competitive pricing pressures in fertility and the LOE of Atozet. We expect the full year impact from price to be in the range of $135 million to $145 million or about 2% with those same Q3 drivers of price being the most significant. This is an improvement over our prior range of $155 million to $185 million. Volumes increased $70 million in the third quarter, representing growth of about 4.5%, driven by the addition of Vtama to the portfolio, continued growth in Emgality and solid performance of Hadlima.

這主要是由於我提到的呼吸系統藥物的強制性價格調整、生育藥物的競爭性價格壓力以及 Atozet 的研發成功率降低。我們預期價格因素對全年業績的影響將在 1.35 億美元至 1.45 億美元之間，約佔 2%，其中第三季的價格因素最為顯著。這比我們先前預測的 1.55 億美元至 1.85 億美元範圍有所改善。第三季銷售量成長 7,000 萬美元，增幅約 4.5%，主要得益於 Vtama 加入產品組合、Emgality 的持續成長以及 Hadlima 的穩健表現。

Given year-to-date performance and our view into the fourth quarter, we estimate that volume could grow about 2.5% for the full year 2025, a revision from our former estimate of 6% to 7%. This would imply low single-digit decline in the fourth quarter and is reflective of continued softness in the respiratory portfolio, persisting policy headwinds in US Nexplanon and a flatter-than-expected ramp of Vtama.

根據今年迄今的業績以及我們對第四季度的展望，我們估計 2025 年全年銷量可能會增長約 2.5%，這比我們之前 6% 至 7% 的估計有所修正。這意味著第四季度將出現個位數低幅的下滑，反映出呼吸系統產品組合持續疲軟、美國 Nexplanon 政策持續受阻以及 Vtama 的成長速度低於預期。

In supply other, here, we captured the lower-margin contract manufacturing arrangements that we have with Merck, which have been declining since the spin-off as expected. And lastly, foreign exchange translation had an approximate $40 million favorable impact in the quarter or about 200 basis points, which reflects the weaker U.S. dollar versus the majority of foreign currencies in which we transact.

在其他供應方面，我們在這裡統計了與默克公司簽訂的利潤率較低的合約生產協議，正如預期的那樣，自分拆以來，這些協議的利潤率一直在下降。最後，外匯折算在本季度產生了約 4000 萬美元的有利影響，或約 200 個基點，這反映了美元對我們交易的大多數外幣走弱。

For the full year, we now expect the impact for FX to represent about a 50 to 70 basis point tailwind to total revenue. Now let's turn to Slide 10, where we show key non-GAAP P&L line items and metrics for the quarter. For reference, financials and reconciliations to the non-GAAP financial measures are included in our press release and the slides in the appendix of this presentation.

我們現在預計，全年外匯波動將對總收入產生約 50 至 70 個基點的利多影響。現在讓我們來看看第 10 張投影片，其中展示了本季的關鍵非 GAAP 損益表項目和指標。作為參考，財務數據以及與非GAAP財務指標的調節表包含在我們的新聞稿和本次簡報的附錄投影片中。

For gross profit, we are excluding purchase accounting amortization and onetime items from cost of goods sold, which can be seen in our appendix slides. Adjusted gross margin was 60.3% for the third quarter compared with 61.7% in the third quarter of 2024. This year-over-year decline in the non-GAAP adjusted gross margin is primarily attributable to pricing pressure, unfavorable product mix and unfavorable foreign exchange on our inventory turns.

對於毛利，我們從銷售成本中剔除了採購會計攤銷和一次性項目，這可以在我們的附錄幻燈片中看到。第三季調整後毛利率為 60.3%，而 2024 年第三季為 61.7%。非GAAP調整後毛利率年減，主要歸因於價格壓力、不利的產品組合以及不利的匯率波動對庫存週轉率的影響。

Adjusted EBITDA this quarter was $518 million, representing a 32.3% margin. Year-to-date, adjusted EBITDA margin is running favorable in part based on the timing of SG&A spend. There are planned increases in our SG&A spend in the fourth quarter as we support growing products such as Vtama and Tofidence. Year-to-date, non-GAAP SG&A as a percentage of sales is 25.4% and given the investments I just mentioned, our latest estimate is about 0.5 point higher than that for the full year.

本季調整後 EBITDA 為 5.18 億美元，利潤率為 32.3%。今年迄今為止，調整後的 EBITDA 利潤率表現良好，部分原因是銷售、一般及行政費用的支出時間表合理。由於我們要支援 Vtama 和 Tofidence 等成長型產品，因此計劃在第四季度增加銷售、一般及行政費用支出。今年迄今為止，非GAAP SG&A 佔銷售額的百分比為 25.4%，考慮到我剛才提到的投資，我們最新的全年估計比這個數字高出約 0.5 個百分點。

Turning to free cash flow on Slide 11. Year-to-date, we've delivered $813 million of free cash flow before onetime costs. Onetime costs related to the spin-off were completed in 2024, following the rollout of our global ERP system. What remains are margin-enhancing restructuring and manufacturing separation activities for 2025, which were $244 million year-to-date.

第 11 頁將討論自由現金流。今年迄今為止，我們在扣除一次性成本前已實現 8.13 億美元的自由現金流。與分拆相關的一次性成本已於 2024 年完成，此前我們已推出全球 ERP 系統。剩餘部分是旨在提高利潤率的重組和製造分離活動（預計到 2025 年完成），截至目前已達 2.44 億美元。

In line with our expectation of $250 million to $300 million for the full year. Year-to-date, these break out as follows: approximately $100 million relates to cash payments associated with the restructuring initiatives that we're executing to deliver $200 million of operating expense savings this year. $20 million relates to the final payment on the [Microspherex] legal settlement and the remaining $120 million relates to the planned exits from supply agreements with Merck.

與我們對全年2.5億至3億美元的預期相符。截至目前，具體構成如下：約1億美元為與我們正在執行的重組計劃相關的現金支付，該計劃旨在今年節省2億美元的運營費用；2000萬美元為[Microspherex]法律和解的最終付款；剩餘的1.2億美元為計劃終止與默克公司的供應協議的相關款項。

These are activities that will enable Organon to redefine our appropriate sourcing strategy and move to fit-for-purpose supply chains, while focusing on delivering efficiencies in terms of gross margin expansion, which we expect to begin realizing in 2027.

這些活動將使 Organon 能夠重新定義我們合適的採購策略，並轉向適合用途的供應鏈，同時專注於提高毛利率，我們預計將在 2027 年開始實現這一目標。

Below the free cash flow line, our estimate of business development cash investments for 2025 is approximately $240 million related to contractual milestones for Vtama, Emgality and the Biosimilar programs with [Shanghai Henlius]. Through the first 9 months of the year, the majority of those payments have already been made. Turning now to leverage on Slide 12.

在自由現金流線下方，我們預計2025年與Vtama、Emgality和生物相似藥計畫相關的業務發展現金投資約為2.4億美元，這些投資用於支付合約里程碑款項。[上海復宏漢霖].今年前9個月，大部分款項已經支付完畢。現在讓我們來利用第 12 張投影片。

Net leverage as of September 30 was approximately 4.2x, down from 4.3x at June 30. Earlier in the year, we took action to realign our capital allocation priorities and target a net leverage ratio of below 4x. To that end, in the second quarter, we repaid approximately $350 million in principal of long-term debt instruments.

截至 9 月 30 日，淨槓桿率約為 4.2 倍，低於 6 月 30 日的 4.3 倍。今年早些時候，我們採取了行動，重新調整了資本配置重點，目標是將淨槓桿率控制在 4 倍以下。為此，在第二季度，我們償還了約 3.5 億美元的長期債務本金。

As I mentioned, once the Jada transaction closes, which we estimate will be Q1 of 2026, we will apply the net proceeds after taxes and transaction costs to lowering our debt balance as well. Given our revised guide, we will likely end the year in line with Q3 with proceeds from the Jada sale helping to move the needle on leverage in early 2026.

正如我之前提到的，一旦 Jada 交易完成（我們預計將在 2026 年第一季完成），我們將把扣除稅款和交易成本後的淨收益用於降低我們的債務餘額。根據我們修訂後的指導，我們今年的業績可能會與第三季度持平，而出售 Ja​​da 所得的收益將有助於在 2026 年初改善槓桿狀況。

Now turning to 2025 full year revenue guidance on Slide 13. Given year-to-date performance and risk adjusting the fourth quarter for what we see as persisting US policy in Nexplanon and the challenges in the respiratory business, we're lowering our full year range to $6.2 billion to $6.25 billion from $6.275 billion to $6.375 billion, which represents a year-over-year nominal decline of 3.2% to 2.4% negative.

現在就來看看第 13 頁投影片中的 2025 年全年營收預期。鑑於年初至今的業績，並考慮到我們認為美國對 Nexplanon 的持續政策以及呼吸系統業務的挑戰，對第四季度進行了風險調整，我們將全年業績預期從 62.75 億美元至 63.75 億美元下調至 62 億美元至 62.5 億美元，同比名義下降 3.2% 至 2.4%。

Given the approximate $35 million to $45 million tailwind we expect from FX for the full year, that means we're revising our constant currency revenue guide down about 300 basis points at the midpoint. We continue to expect adjusted gross margin to be in the range of 60% to 61%. Year-to-date strength in adjusted gross margin is likely to be partially offset in the fourth quarter due to product mix.

鑑於我們預計全年外匯市場將帶來約 3500 萬至 4500 萬美元的利好，這意味著我們將按固定匯率計算的收入預期中位數下調約 300 個基點。我們仍然預計調整後的毛利率將在 60% 至 61% 之間。由於產品組合的變化，今年迄今調整後毛利率的強勁成長動能可能會在第四季被部分抵銷。

For OpEx, as I mentioned earlier, given expected investments in Vtama, we expect full year SG&A spend as a percentage of revenue to be about 0.5 point higher than the year-to-date figure, which puts us in the 26% area for the full year. We continue to expect R&D as a percentage of sales to be in the upper single-digit range. The math on all those components gets you closer to the lower end of the 31% to 32% adjusted EBITDA margin range we laid out in August of this year.

對於營運支出，正如我之前提到的，考慮到對 Vtama 的預期投資，我們預計全年銷售、一般及行政費用佔收入的百分比將比年初至今的數字高出約 0.5 個百分點，這將使我們全年達到 26% 左右。我們仍預期研發支出佔銷售額的比例將維持在個位數高點。所有這些組成部分的計算結果都接近了我們今年 8 月提出的 31% 至 32% 的調整後 EBITDA 利潤率範圍的下限。

So we are revising our adjusted EBITDA margin to approximately 31% for the full year. For below-the-line items, our estimate for full year 2025 interest expense remains at $510 million. The lower interest expense from voluntarily retired debt is essentially fully offset by higher euro-denominated interest expense due to FX translation, and an acceleration of noncash amortization of capitalized fees related to the early debt retirement.

因此，我們將全年調整後的 EBITDA 利潤率修正為約 31%。對於線下項目，我們對 2025 年全年利息支出的估計仍為 5.1 億美元。自願償還債務帶來的較低利息支出基本上被匯率折算導致的較高歐元計價利息支出以及與提前償還債務相關的資本化費用的非現金攤銷加速所完全抵消。

As we think about next year, we would expect the interest expense to be closer to a $450 million to $475 million run rate as a result of the voluntary debt repayments completed, lower variable interest rates and applying the net proceeds from Jada to debt repayment. For 2025, we continue to estimate our non-GAAP tax rate to be in the range of 22.5% to 24.5%.

展望明年，由於自願償還債務、浮動利率降低以及將 Jada 的淨收益用於償還債務，我們預計利息支出將接近 4.5 億美元至 4.75 億美元的年化水準。對於 2025 年，我們繼續預期我們的非 GAAP 稅率將在 22.5% 至 24.5% 之間。

The uptick from 2024 is largely due to the impact of the 15% global minimum tax rate required under the [OECD's] Pillar 2. Depreciation of $135 million remains our estimate for the full year 2025. At a very high level, next year pro forma for the Jada divestiture, we would expect consolidated revenue to be about flat as Vtama and Emgality and Biosimilars growth offset the headwinds across the respiratory portfolio. For Nexplanon, assuming existing headwinds in the US don't worsen and factoring in the volume and price variables associated with a 5-year launch in the US and continued growth internationally, we expect global Nexplanon revenues could be about flat next year.

2024 年的成長主要是由於經合組織第二支柱規定的 15% 全球最低稅率的影響。我們對 2025 年全年的折舊額估計仍為 1.35 億美元。從宏觀層面來看，考慮到 Jada 的剝離，我們預計明年合併收入將基本持平，因為 Vtama 和 Emgality 以及生物相似藥的增長抵消了呼吸系統產品組合的不利因素。對於 Nexplanon 而言，假設美國現有的不利因素不會惡化，並考慮到與在美國 5 年內推出以及在國際上持續增長相關的銷量和價格變量，我們預計明年 Nexplanon 的全球收入可能會基本持平。

We remain confident in our ability to continue to deliver the balance sheet through disciplined expense management and prudent capital allocation, all of which will strengthen Organon's financial position and support greater financial flexibility in the future.

我們仍然有信心透過嚴格的費用管理和審慎的資本配置，繼續保持良好的資產負債表，所有這些都將加強 Organon 的財務狀況，並在未來支持更大的財務靈活性。

Importantly, even in a challenging environment, our diverse portfolio continues to generate strong cash flows and provides a solid foundation for long-term value creation. We are committed to navigating the current headwinds, investing behind our growth drivers and delivering for patients, customers and shareholders. And finally, while the issue raised around certain of the company's wholesaler sales practices is receiving a lot of focus, the financial impacts are small. Remediation is well underway. And as an organization, we are moving forward. With that, operator, let's open the line for questions.

重要的是，即使在充滿挑戰的環境下，我們多元化的投資組合仍然能夠持續產生強勁的現金流，並為長期價值創造奠定堅實的基礎。我們致力於克服當前的逆境，增加對成長動力的投入，為病患、客戶和股東創造價值。最後，雖然圍繞該公司某些批發商銷售行為提出的問題受到了廣泛關注，但其財務影響卻很小。補救工作正在順利進行中。作為一個組織，我們正在向前發展。好了，接線員，我們現在開始接受提問。

[Operator Instructions] Your first question comes from Jason Gerberry, Bank of America.

[操作員說明] 您的第一個問題來自美國銀行的傑森‧格伯里。

My question is mainly, given the Jada divestiture, are there opportunities within the portfolio for additional divestitures as you look across? And then as my follow-up, just on Vtama, I appreciate the update as it pertains to the growth dynamics into year-end. When should we start thinking about a growth inflection? Do you feel like next year when the access barriers improve that 2026 is the time point to really evaluate whether or not the growth inflections achieved with the [AD] label?

我的問題主要是，鑑於 Jada 的剝離，從整體上看，投資組合中是否還有進一步剝離的機會？然後，作為我的後續補充，僅針對 Vtama，我很感謝您提供的有關年底增長動態的最新資訊。我們應該何時開始考慮成長拐點？您是否認為，明年隨著准入障礙的改善，2026 年將是真正評估 [AD] 標籤所取得的成長拐點是否到來的時機？

Thanks, Jason. We'll start with question. So to be clear, we've got nothing that's been announced or is definitively planned on asset divestitures, we're constantly from a strategic basis, looking at all of the assets in our portfolio. and anything additional would be opportunistic.

謝謝你，傑森。我們先從一個問題開始。所以需要明確的是，我們目前沒有任何已宣布或明確計劃的資產剝離計劃，我們始終從戰略角度審視投資組合中的所有資產，任何額外的舉措都屬於投機取巧。

I think in the case of Jada, we looked very hard at what is the economic value created in a hold and invest scenario and compare that against the opportunity to put that product in the hands of a better owner and the right economic answer in the math indicated that divestiture was the right answer in that case, but that is the kind of rigor that we'll put across all the assets in our portfolio.

我認為就 Jada 而言，我們非常認真地研究了持有和投資方案所創造的經濟價值，並將其與將產品交給更合適的擁有者的機會進行了比較。數學計算得出的正確經濟答案表明，在這種情況下，剝離是正確的選擇。但這種嚴謹的態度，我們將應用於我們投資組合中的所有資產。

And as regards Vtama, Vtama has grown nicely this year, will grow again next year. To your point, we have -- we have made significant strides to improve access in 2026. And so I think full year 2026 will be a very good basis for us to be judging where we are on the growth trajectory to achieving long-term peak revenue of that roughly $0.5 billion that underpin the investment for us in the first place. So yes, 2026 will be a key year.

至於Vtama，它今年長得很好，明年還會繼續生長。正如您所說，我們已經－我們已經取得了重大進展，以期在 2026 年改善人們的獲取途徑。因此，我認為 2026 年全年將是一個很好的基準，讓我們能夠判斷我們在實現長期高峰收入（約 5 億美元）的成長軌跡上處於什麼位置，而這正是我們最初進行投資的基礎。所以，2026年將是關鍵的一年。

The next question comes from David Amsellem, Piper Sandler.

下一個問題來自大衛·阿姆塞勒姆（Piper Sandler）。

So a couple for me. Firstly, can you talk more about the pressure on respiratory? And should we think of this long term as a declining business, not just '26, but beyond? And then secondly, how are you thinking about other potential trouble [spots] trouble spots, as you say, regarding established brands? So that's number one. And then number two is on Vtama.

所以對我來說，是一對。首先，您能詳細談談呼吸壓力嗎？我們是否應該將這種長期趨勢視為業務衰退，不僅是2026年，而是更遠的未來？其次，您如何看待其他潛在的問題點，也就是您所說的，關於成熟品牌的問題點？這是第一點。第二點是關於Vtama的。

Just wanted to get your thoughts on competitive dynamics here. Is there anything you feel like you're missing regarding the topical landscape vis-a-vis the [roflumilast] product in particular and how we should think about that and how that plays into your -- thinking regarding the product?

想聽聽你對這裡競爭格局的看法。關於羅氟司特（roflumilast）產品在局部應用方面，您是否覺得有什麼遺漏之處？我們該如何看待這個問題？這個問題又如何影響您對該產品的看法？

Sure. So we'll start with the respiratory piece of your question, David. So in the early part of the year, we were noting that the allergy season, specifically in the Asia Pacific region, including China, was off to a very slow start. That put a dent in our thinking about the full year performance of the respiratory business. But then as the year progressed, we were noting that competitively speaking, the age of certain products in the respiratory portfolio is working against them.

當然。那麼，我們就先從你問題中關於呼吸系統的部分開始回答吧，大衛。因此，在今年年初，我們注意到過敏季節，尤其是在包括中國在內的亞太地區，開始得非常緩慢。這讓我們對呼吸系統業務全年的業績預期產生了懷疑。但隨著時間的推移，我們注意到，從競爭角度來看，呼吸系統產品組合中某些產品的上市時間較長，這對它們不利。

Various health ministries around the world were starting to prioritize other molecules above, for example, Singulair. And then elsewhere in the portfolio, thinking about Dulera, we talked about that in the prepared comments in terms of the rate pressures that product is facing in the United States.

世界各地的衛生部門開始優先考慮其他分子，例如順爾寧（Singulair）。然後，在投資組合的其他方面，考慮到 Dulera，我們在準備好的評論中談到了該產品在美國面臨的利率壓力。

And then rounding [and] out just mandatory price downs in China and Japan and also just around the world, hit that business pretty hard this year. So as we said, we expect that softness to continue into 2026. We'll see what sort of allergy season we have with some of the other dynamics I've spoken about are more longer term in nature.

再加上中國、日本以及世界各地強制降價，今年對這個行業造成了相當大的打擊。正如我們所說，我們預計這種疲軟態勢將持續到 2026 年。我們將拭目以待，看看今年的過敏季會是什麼樣的，而我之前提到的一些其他因素則具有更長遠的意義。

Apart from that, the rest of the established brands portfolio is showing the stability that those products have demonstrated over long periods of time. But we've always said about the established brands business, it is a business that we felt, if managed very tightly, we could keep about flat or maybe very, very low single-digit rate of rate of decline.

除此之外，其他成熟品牌組合也展現出這些產品長期以來所展現的穩定性。但我們一直認為，對於成熟品牌業務，如果管理得當，我們可以將其保持平穩，或將下降率控制在非常非常低的個位數。

That is on a CAGR basis. Some years will be different than others. We've added to the established brands portfolio, having a global commercial infrastructure like we do is an asset. So products like Emgality tucked in very nicely. And Emgality continues to grow. And now the wave two markets now that we've added them, I think, are a case in point for what we can do with the infrastructure that we have. So no other trouble spots that we're managing at the moment.

這是以複合年增長率計算的。有些年份會與其他年份不同。我們擴充了現有品牌組合，擁有像我們這樣的全球商業基礎設施是一項優勢。因此，像 Emgality 這樣的產品就很好地融入其中了。平等意識仍在不斷增強。現在，我們已經增加了第二波市場，我認為，這正是我們利用現有基礎設施可以取得成就的一個例子。所以目前我們沒有其他需要處理的問題。

Vtama from a competitive standpoint, we are forced to market in the atopic dermatitis space with a nonsteroidal offering. So that has set the stage, I think, as what you -- what you would say about competition. The product, as we mentioned in the prepared comments, is really differentiated in terms of drug-to-drug interactions, no restrictions on use, no limitations on a percentage of a body air. So it's a very safe product.

從競爭的角度來看，Vtama 被迫以非類固醇藥物進入異位性皮膚炎市場。所以，我認為這為接下來你會如何看待競爭奠定了基礎。正如我們在準備好的評論中提到的，該產品在藥物交互作用方面確實與眾不同，使用沒有限制，對體內空氣百分比也沒有限制。所以這是一款非常安全的產品。

And we're looking to differentiate it with those patients for whom those characteristics are very important, including pediatrics.

我們希望透過這種方式來區別於那些非常重視這些特徵的患者群體，包括兒科患者。

The next question comes from Umer Raffat, Evercore ISI.

下一個問題來自 Evercore ISI 的 Umer Raffat。

I wanted to start by commending you for getting the 10-Q out, but I realize we haven't been able to speak at all since the inventory disclosures a few days ago. So I feel like it's only fair that we don't limit to just one question. So here's what I wanted to address on this public call.

首先我想表揚你提交了 10-Q 表格，但我意識到自從幾天前披露庫存資訊以來，我們一直沒有機會交流。所以我覺得我們不應該只提一個問題，這才是公平的。所以，我想在這次公開電話會議上談談以下幾點。

First, the audit committee investigation focused on Nexplanon. How do we know that the behavior was just limited to Nexplanon? Because inventory visibility is always lower [ex] US. So how do we know? Second, the filings point to the CEO and the Head of US Commercial as where divergence happened. But I also saw your Chief Commercial Officer left back in February last -- this year as well. Why was that?

首先，審計委員會的調查重點是Nexplanon植入劑。我們怎麼知道這種行為僅限於 Nexplanon？因為庫存可見性總是較低（例如美國）。那我們怎麼知道呢？其次，文件顯示，分歧出在執行長和美國商業主管身上。但我還看到你們的首席商務官在去年二月離職了——今年也是如此。為什麼會這樣呢？

Third, for 2024, your net pull forward is only $10 million, but the discounts and rebates paid to the channel went up by $177 million in '24, which puzzles me. So could you elaborate on that? Additionally, 4Q [ '20 ] had some inventory as well, but I didn't see any color on that. And then finally, the scale of these issues seems fairly low, fairly manageable, $10 million, $15 million sub $20 million. But if that's the case, then why the need to start this divestiture plan.

第三，2024 年，你們的淨增長額只有 1,000 萬美元，但支付給通路的折扣和回扣在 2024 年卻增加了 1.77 億美元，這讓我很困惑。能詳細解釋一下嗎？此外，2020 年第四季也有一些庫存，但我沒有看到任何顏色。最後，這些問題的規模似乎相當小，相當容易控制，1,000萬美元、1,500萬美元，不到2,000萬美元。但如果真是這樣，那為什麼還需要啟動這項資產剝離計畫呢？

As I mentioned in my comments, the independent internal investigation around the improper sales practices with Nexplanon in the US was with two wholesalers, and it's now complete. The investigation also looked other product areas and found nothing else at this time. So we believe that we are done with the investigation now and we're moving forward into the remediation efforts.

正如我在評論中提到的，針對美國 Nexplanon 不當銷售行為的獨立內部調查針對的是兩家批發商，目前調查已經完成。調查還涉及其他產品領域，但目前尚未發現其他問題。因此，我們認為調查已經結束，現在正著手進行補救工作。

Again, as I mentioned, that's things like enhancing our controls. We have taken certain personnel actions. We believe that's completed. We're doing additional training and we've got more written procedures and more training yet to come. So with the new leadership at the company, we're comfortable that we're moving forward, and we will continue to execute against our goals as stated. Matt, do you want to take the others?

正如我之前提到的，這包括增強我們的控制功能等。我們已採取一些人事措施。我們認為這件事已經完成了。我們正在進行額外的培訓，還有更多書面程序和培訓即將推出。因此，有了公司新的領導層，我們相信公司正在向前發展，我們將繼續按照既定目標執行計劃。馬特，你想帶其他人嗎？

Yes. So for the Nexplanon piece, as we stated in the prepared commentary [ or ] the marketplace for long-acting reversible contraceptives has gotten more competitive. And so we are meeting that competition partially on price. So that would result in some of the increases in rebates and discounts that you noted. This is just I would say, normal business and Nexplanon operating in a competitive marketplace where women have lots of options for contraception.

是的。所以對於 Nexplanon 而言，正如我們在準備好的評論中所述，長效可逆避孕藥的市場競爭變得更加激烈。因此，我們部分是透過價格來應對這種競爭的。所以，正如您所提到的，這會導致一些回扣和折扣的增加。我認為這只是正常的商業行為，Nexplanon 在競爭激烈的市場中運營，女性有很多避孕選擇。

[And] on the Q4 2022 disclosure here. We did. It wasn't on our slides, but as disclosed in the 10-K.

[以及] 2022 年第四季揭露的資訊。我們做到了。雖然我們的幻燈片上沒有提到，但 10-K 文件中披露了這一點。

Umer, you had a number of other questions. I just want to make sure we get to them all. Can you repeat the ones that you don't think we've answered yet?

烏默，你還有其他一些問題。我只是想確保我們能聯繫到所有人。你能再重複一下你認為我們還沒回答的問題嗎？

Yes, sure. Maybe for ['22], that wasn't disclosed also the Chief Commercial Officer, who left separate from the Head [of] and then why do all the divestitures now?

當然可以。也許對於[22]年來說，首席商務官的離職與負責人無關，也沒有披露，那麼為什麼現在要進行所有這些資產剝離呢？

So for Q4 of 2022, the revenue was impacted by -- I think it was about 1.5% on the quarter, 0.3% for the year. And the divestitures, I think we've already addressed that. Umer, we had an opportunistic chance to divest an asset for which the economic value received on an immediate basis was what was superior to the [whole] and invest option.

因此，2022 年第四季的收入受到了影響——我認為當季下降了約 1.5%，全年下降了約 0.3%。至於資產剝離的問題，我認為我們已經討論過了。Umer，我們當時有機會剝離一項資產，而剝離該資產立即獲得的經濟價值優於[整體]投資選擇。

And we had an employee retire towards the end of last year that was for that employee's personal reasons and not tied to the investigation anyway.

去年年底，我們有一名員工退休了，這是該員工的個人原因，與調查無關。

The next question comes from Chris Schott, JPMorgan.

下一個問題來自摩根大通的克里斯·肖特。

Just two questions for me. Maybe, [Cary], can you just talk a little bit about the new CEO search and kind of what's the optimal background and profile you're looking for here? And as part of either the search or with the new CEO coming in, should we assume a review of the broader strategy at Organon as part of this process?

我只有兩個問題。或許，[Cary]，你能稍微談談新任CEO的遴選工作，以及你們正在尋找的最佳人選背景和素質嗎？無論是在尋找新任執行長的過程中，還是隨著新任執行長的到來，我們是否應該假設 Organon 會在此過程中對更廣泛的策略進行審查？

And then my follow-up, just on Nexplanon. Thank you for the comments about the flat growth next year. Just can you add a little bit more and what that -- in terms of what that implies for these funding challenges and the impact of the 5-year launch on the US revenue?

然後，我的後續文章是關於 Nexplanon 的。感謝您對明年經濟成長停滯的評論。您能否再補充一點，說明一下這對這些資金挑戰意味著什麼，以及五年啟動計畫對美國收入的影響？

Thanks, Chris. The board formed a search committee essentially immediately, [the] committee has been hard at work. So we are in the process of conducting that search. And like any company at this point, we need someone who's got the global experience, the strategic experience, the operational depth and a deep understanding of the businesses in which we operate.

謝謝你，克里斯。董事會立即成立了遴選委員會，該委員會一直在努力工作。所以我們正在進行這項搜尋工作。就像任何一家公司一樣，我們需要一位擁有全球經驗、策略經驗、營運深度以及對我們所經營的業務有深刻理解的人才。

So we are confident that -- we not only have a great interim CEO that will continue to find good candidates as we go forward. I think the strategic discussion obviously waits for a permanent CEO. But at this point, we've been reaffirming that we don't see any strategic changes.

因此我們有信心——我們不僅擁有一位優秀的臨時首席執行官，而且在未來的發展過程中，他將繼續尋找優秀的候選人。我認為戰略討論顯然要等到有了正式的執行長之後才能進行。但目前為止，我們一直重申，我們認為不會有任何策略變化。

So I would say we are what we are right now, and we intend to continue that way and very much focused on driving towards our goals. Matthew WalshExecutive I'll take the second part of the question on Nexplanon. So in terms of our current view of Nexplanon being about flat next year, the components of that, we expect the product to continue to grow internationally.

所以我認為我們現在就是這樣，我們打算繼續保持這種狀態，並專注於實現我們的目標。Matthew WalshExecutive 我將回答關於 Nexplanon 的第二部分問題。因此，就我們目前對 Nexplanon 明年基本持平的看法而言，我們預計該產品將在國際上繼續成長。

From a policy perspective, assuming things don't get any worse, what we would probably see is an annualization of the issues that we experienced in the second half. And then the 5-year which we are assessing the relative weighting of the impacts of volume growth as the product would be appealing to a larger segment of the addressable population with a 5-year indication versus 3.

從政策角度來看，假設情況不再惡化，我們可能會看到下半年遇到的問題逐年出現。然後是 5 年，我們正在評估銷售成長影響的相對權重，因為 5 年適應症比 3 年適應症對目標族群的吸引力更大。

The volume decline that would come from lower reinsertions, right, as women who would be coming up to the 3-year limit can leave the rod in their arms now for longer. And then what we're able to do on the pricing front. So we'll have all of this sorted out more precisely when we guide in February. But these are the things, Chris, that would be pushing and pulling on the overall belief that revenue will be about flat next year.

數量下降的原因在於再次植入次數減少，對吧？因為即將達到 3 年期限的女性現在可以將鋼釘留在手臂中更長時間。然後是我們能夠在定價方面做些什麼。所以，等到二月我們開始帶隊的時候，我們會把所有這些事情都安排得更具體一些。但克里斯，正是這些因素會影響人們對明年營收將基本持平的整體看法。

The next question comes from Terence Flynn, Morgan Stanley.

下一個問題來自摩根士丹利的特倫斯·弗林。

I just had one follow-up on the CEO search. I was wondering if you can speculate on the duration of the search when you hope to have someone in place on a permanent basis? And then on denosumab on that product, obviously, one of your newer Biosimilars that you're launching. [Amgen] has expressed a lot of optimism about maintaining more share on the [Prolia] side versus [XGEVA]. Can you just talk through your expectations for fourth quarter, but then also into 2026?

我剛剛跟進了一下CEO的招聘事宜。我想問一下，您能否大致估算一下，您希望找到一位能夠長期任職的人選，那麼尋找合適人選的過程需要多長時間？然後是關於地諾單抗的產品，顯然，這是你們即將推出的新型生物相似藥之一。 [安進]對維持[Prolia]的市佔率非常樂觀。[XGEVA]。您能否談談您對第四季以及2026年的預期？

So on timing of the CEO search, you know it's always impossible to predict how long these things take. The Board did begin right away. So I'm confident we're doing what's necessary to go as fast as we can. But we also feel very good about putting Joe in as our interim CEO, and I've stepped in to assist him along with Matt, of course. So we're confident we can continue to run the company well in the interim, and we'll be moving through the search as fast as appropriately we can go.

所以，關於CEO遴選的時間安排，你知道，這類事情需要多久總是無法預測的。董事會立即開始運作。所以我相信我們正在採取一切必要措施，以最快的速度前進。但我們也非常樂意讓喬擔任我們的臨時首席執行官，當然，我也和馬特一起協助他。因此，我們有信心在此期間繼續妥善經營公司，並將以盡可能快的速度推進招募工作。

And on the denosumab piece, we're obviously very excited about that product. It's launched now. We don't guide to specific products, as you know. But what we are excited about is we continuously are adding products to the bag in our U.S Biosimilars business and that's giving us increasing commercial presence and access advantages that we look forward to 2026 for [Topdenter] and for all of our US Biosimilars.

至於地諾單抗，我們顯然對這款產品感到非常興奮。現在已經上線了。如您所知，我們不推薦特定產品。但令我們興奮的是，我們不斷為美國生物相似藥業務增加產品，這使我們獲得了不斷增強的商業影響力和市場准入優勢，我們期待著 [Topdenter] 以及我們所有的美國生物類似藥在 2026 年取得更大的成就。

The next question comes from Navann Ty with BNP Paribas.

下一個問題來自法國巴黎銀行的Navann Ty。

I have some questions on capital allocation. If you could discuss the future BD in women's health biopharma, only I understand and the timing of business development versus deleveraging progress? And second, if you could also discuss your pipeline versus the cost discipline strategy, including lower R&D?

我有一些關於資本配置的問題。如果您能談談只有我了解的女性健康生物製藥領域未來的業務拓展，以及業務拓展與去槓桿化進程之間的時機安排，那就太好了？其次，您能否也談談您的產品線與成本控制策略之間的關係，包括降低研發投入？

Yes. Thank you, Navann. So our business development activities in women's health continue. To the question that you're asking, we -- just because of where the balance sheet is, we've had to focus on later-stage assets or currently marketed assets. You can see that clearly in the kinds of deals that we have announced that we've announced recently.

是的。謝謝你，納萬。因此，我們在女性健康領域的業務拓展活動仍在繼續。對於你提出的問題，我們——僅僅因為資產負債表的現狀，我們不得不專注於後期資產或目前正在銷售的資產。從我們最近宣布的各項交易中，這一點可以清楚看出。

And the challenge in women's health is there aren't a lot of those assets that are available late stage are currently marketed. A lot of [the] truly exciting things in women's [health] are preclinical or generally speaking, much earlier in the development cycle.

女性健康領域面臨的挑戰是，目前市面上並沒有很多處於後期階段的可用資源。女性健康領域許多真正令人興奮的事情都處於臨床前階段，或者更確切地說，處於發育週期的早期階段。

So we are somewhat constrained in our ability to go after those, and that's one of the reasons why we've been prioritizing leverage reduction, debt repayment in our capital allocation strategies so that we can free up the ability, balance sheet and P&L to bring on the clinical programs, especially in women's health that are preclinical or early stage.

因此，我們在追求這些目標方面的能力受到一定限制，這也是我們優先考慮降低槓桿率、償還債務的資本配置策略的原因之一，這樣我們就可以釋放能力、資產負債表和損益表，從而開展臨床項目，特別是處於臨床前或早期階段的女性健康項目。

Once again, because of the financial challenges facing the company, we've applied that same rigor, not just to the BD we're looking at, but also to the pipeline that we are managing in-house. And we've had to trim some programs. Those weren't restricted to women's health.

再次，由於公司面臨財務挑戰，我們不僅對我們正在考察的業務拓展，而且對我們內部管理的業務線，都採用了同樣的嚴格標準。我們不得不削減一些項目。這些並不局限於女性健康。

We've got life cycle management activities across a number of products in the portfolio, but it's incumbent upon a supply that same kind of financial rigor and discipline to things inside the company as well as any capital deployments we might do externally.

我們對產品組合中的許多產品都進行了生命週期管理活動，但我們必須對公司內部的各項事務以及我們可能進行的任何外部資本部署，都保持同樣的財務嚴謹性和紀律性。

The next question comes from Mike Nadelkovich, TD Cowen.

下一個問題來自 TD Cowen 的 Mike Nadelkovich。

I have one actually something of a follow-up on the BD response you just gave, I think with today's updates, it's fair to say that business development track record is somewhat mixed. So I'm wondering what you could do from here to improve it, especially given how important BD is to potential growth for Organon.

實際上，我有一個關於您剛才給出的業務拓展回應的後續問題。我認為根據今天的更新，可以說業務拓展記錄是喜憂參半。所以我想知道從現在開始，您能做些什麼來改進它，特別是考慮到業務拓展對 Organon 的潛在成長有多重要。

And could that options that include expanding to therapeutic categories well beyond women's health?

這些選擇是否包括將治療類別擴展到女性健康以外的更廣泛領域？

So thank you for the question. I think we've shown success in the BD program, especially with later-stage assets where we've got synergies with our existing commercial capabilities. So the broad strategy just doing more of what we already do well. I think Emgality is a terrific example of that.

謝謝你的提問。我認為我們在業務拓展計劃中取得了成功，尤其是在後期資產方面，我們能夠與我們現有的商業能力產生協同效應。所以，整體戰略就是繼續做好我們已經做得好的事情。我認為平等就是一個很好的例子。

With the addition of Dermavant, we actually did already add a completely new vertical in the United States with dermatology. Right now, the Dermavant team that we added, which is now Organon's dermatology sales force is selling just one product.

隨著 Dermavant 的加入，我們實際上已經在美國新增了一個全新的皮膚科業務領域。目前，我們新加入的 Dermavant 團隊（現在是 Organon 的皮膚科銷售團隊）只銷售一種產品。

So we would have synergies going forward as we look to add additional derm products to that team. And we're already in, when you look at the [savage] Brands business, we're already in a pretty broad range of therapeutic categories outside the United States.

因此，隨著我們未來計劃為該團隊增加更多皮膚科產品，我們將實現協同效應。而且，當你審視[Savage] Brands的業務時，你會發現我們已經涉足美國以外的相當廣泛的治療類別。

So we believe that we've got lots of opportunities with the therapeutic areas we're already in with what we've already added with Dermavant so that we wouldn't necessarily need to add another therapeutic category in order to be successful with capital deployments, although we certainly wouldn't rule it out if it capitalizes once again on some functional expertise that we already have, whether it's the global commercial network or perhaps there's something that aligns particularly well with our manufacturing capabilities, for example.

因此，我們相信，憑藉我們目前所處的治療領域以及Dermavant的加入，我們已經有很多機會，所以我們不一定需要增加另一個治療類別才能在資本部署方面取得成功。當然，如果能夠再次利用我們已有的某些職能專長，例如全球商業網絡，或某些與我們的生產能力特別契合的領域，我們當然也不會排除這種可能性。

This concludes the question-and-answer session and will conclude today's conference call and webcast. Thank you for joining. You may now disconnect.

問答環節到此結束，今天的電話會議和網路直播也將結束。感謝您的參與。您現在可以斷開連線了。