Organon & Co (OGN) 2025 Q1 法說會逐字稿

Hello, and welcome to the Organon first quarter 2025 earnings call and webcast (Operator Instructions)

您好，歡迎參加 Organon 2025 年第一季財報電話會議及網路直播（操作員指示）

I would now like to turn the conference over to Jennifer Halchak, Vice President, Investor Relations. You may begin.

現在，我想將會議交給投資者關係副總裁 Jennifer Halchak。你可以開始了。

Thank you, operator, and good morning, everyone. Thank you for joining Organon's first quarter earnings call. With me today are Kevin Ali, Organon's Chief Executive Officer; and Matt Walsh, our Chief Financial Officer. Juan Camilo Arjona Ferreira, Organon's Head of R&D will also be joining for the Q&A portion of this call.

謝謝接線員，大家早安。感謝您參加 Organon 第一季財報電話會議。今天和我一起的還有 Organon 的執行長 Kevin Ali；以及我們的財務長 Matt Walsh。Organon 研發部主管 Juan Camilo Arjona Ferreira 也將參加本次電話會議的問答環節。

Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast. This presentation will also be available following this call on the Events and Presentations section of our Investor Relations website, www.organon.com.

今天，我們將在本次電話會議期間為網路廣播中的各位觀眾提供一份簡報。本次電話會議結束後，您也可以在我們的投資者關係網站 www.organon.com 的活動和簡報部分查看此簡報。

Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements. 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 Securities and Exchange Commission, including our 10-K and subsequent periodic filings.

在我們開始之前，我想提醒聽眾，管理層在本次電話會議中討論的某些資訊將包括前瞻性陳述。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陳述中明示或暗示的結果存在重大差異，這些風險和不確定性在公司向美國證券交易委員會提交的文件中進行了討論，包括我們的 10-K 和後續定期文件。

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 the press release and conference call presentation.

此外，我們將在本次電話會議上討論某些非 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。新聞稿和電話會議介紹中包含了這些非 GAAP 指標與可比較 GAAP 指標的對帳。

I'd now like to turn the call over to our CEO, Kevin Ali.

現在我想將電話轉給我們的執行長凱文·阿里 (Kevin Ali)。

Good morning, everyone, and thank you, Jen. Our first quarter results represented a solid start to 2025, and we're very much in line with our expectations for the year. Key growth drivers are on track. Nexplanon grew double-digit and is set to achieve more than $1 billion in revenue in 2025.

大家早安，謝謝你，Jen。我們第一季的業績代表著 2025 年的一個良好開端，並且與我們對今年的預期非常一致。主要成長動力正步入正軌。Nexplanon 實現了兩位數成長，預計到 2025 年收入將超過 10 億美元。

The launch of Vtama in the atopic dermatitis indication has been successful, ramping just as expected, and the product is marching towards $150 million of revenue for the year. Additionally, we continue to estimate that our restructuring initiatives will yield approximately $200 million of annual savings.

Vtama 在治療異位性皮膚炎方面的推出取得了成功，銷量正如預期的那樣增長，該產品今年的收入預計將達到 1.5 億美元。此外，我們繼續估計，我們的重組措施每年將節省約 2 億美元。

Given the tariff policies in effect as of today, we're affirming our revenue and adjusted EBITDA margin guidance, as well as our target of generating over $900 million of free cash flow before one-time costs in 2025. Today, we also announced that we have reset our dividend payout and will redirect those funds to debt reduction.

鑑於今天生效的關稅政策，我們確認我們的收入和調整後的 EBITDA 利潤率指引，以及我們在 2025 年扣除一次性成本之前產生超過 9 億美元自由現金流的目標。今天，我們也宣布，我們已經重新設定了股息支付，並將把這些資金用於減少債務。

With a reduced dividend payout, the company can redeploy almost $200 million in prospective dividend payments over the remainder of 2025 that will enable a path to achieve a net leverage ratio below four by year-end.

透過減少股息支付，該公司可以在 2025 年剩餘時間內重新部署近 2 億美元的預期股息支付，預計在年底前實現低於 4 的淨槓桿率。

Over the last year, we have established a leaner, more fit-for-purpose cost structure while increasing revenue contribution from our core growth drivers. By deleveraging more rapidly, we will continue to strengthen the future prospects of the company.

在過去的一年裡，我們建立了更精簡、更適合的成本結構，同時增加了核心成長動力的收入貢獻。透過更快地去槓桿，我們將繼續增強公司的未來前景。

Over time, this will position us to execute more of the compelling business development opportunities we've done to date, bringing in additional growth drivers to our portfolio while maintaining lower leverage. Further, the recent macroeconomic uncertainty has created a pronounced dislocation in our equity valuation relative to our earnings. To us, this is an affirming signal from the market that now is the right time to proactively take action to support our balance sheet.

隨著時間的推移，這將使我們能夠執行迄今為止已完成的更多引人注目的業務發展機會，為我們的投資組合帶來額外的成長動力，同時保持較低的槓桿率。此外，近期宏觀經濟的不確定性導致我們的股票估值相對於收益出現明顯錯置。對我們來說，這是來自市場的一個肯定訊號，表明現在是主動採取行動支持資產負債表的正確時機。

A lot of the uncertainty in the broader market obviously centers around current and future tariff policy. Based on tariffs in place as of today, we have very limited exposure in 2025. Our revenue composition is about 75% ex-US Europe, Canada represents about 25% of our total revenue. China represents about 13% of our revenue. And for that revenue generated in China, a majority of the supply comes from Europe.

顯然，大盤中的許多不確定性都集中在當前和未來的關稅政策上。根據目前實施的關稅，我們在 2025 年的風險敞口非常有限。我們的收入組成中約 75% 來自美國以外的歐洲，加拿大約占我們總收入的 25%。中國約占我們收入的13%。而在中國產生的收入中，大部分供應來自歐洲。

As you think about the roughly 25% of our revenue generated in the US again, most of that supply comes from Europe. Our women's health products sold in the US are primarily made in the Netherlands. Nexplanon is the bulk of that, and we have already taken steps to mitigate exposure through inventory management. For US biosimilars, Ontruzant, Renflexis and Hadlima are mainly supplied from Korea and the EU.

當您再次想到我們約 25% 的收入來自美國時，大部分供應來自歐洲。我們在美國銷售的女性保健產品主要在荷蘭生產。Nexplanon 佔了其中的大部分，我們已經採取措施透過庫存管理來減少風險。對於美國生物相似藥，Ontruzant、Renflexis 和 Hadlima 主要來自韓國和歐盟。

For recently acquired Tofidence, that product is manufactured in China, but we have inventory coverage offering us protection through 2025. The denosumab asset from Shanghai Henlius is not planned to launch until much further in the year. So, again, based on the tariffs in place as of today, we have very limited exposure in 2025.

對於最近收購的 Tofidence，該產品在中國製造，但我們有庫存保障，可以為我們提供到 2025 年的保障。上海復宏漢霖的地舒單抗資產計畫在今年稍後推出。因此，再次強調，根據目前實施的關稅，我們在 2025 年的風險敞口非常有限。

With those important topics addressed, let's move now to a discussion of the financial results. As I mentioned, the first quarter was very much in line with our expectations. We had guided that first quarter would be the lightest of the year as we work through the loss of exclusivity of Atozet and as Vtama ramped up.

在討論了這些重要主題之後，現在讓我們來討論財務結果。正如我所提到的，第一季的表現非常符合我們的預期。我們曾預計，由於我們正努力克服 Atozet 獨家經營權的喪失以及 Vtama 業務的擴張，第一季將是今年業績最輕的季度。

The women's health franchise grew 12% ex-exchange, led by performance of Nexplanon, which was up 14% in the quarter. Nexplanon grew double-digit in both the US and ex-US markets. This year, we expect Nexplanon to deliver more than $1 billion in sales, driven by both price increase and demand growth. For the five-year indication, we have made our submission to the FDA, putting us in a position to be ready for a late 2025 launch pending FDA approval.

女性健康特許經營業務年增 12%，其中 Nexplanon 的業績最為亮眼，本季成長了 14%。Nexplanon 在美國和美國以外市場均實現了兩位數的成長。今年，我們預計 Nexplanon 的銷售額將超過 10 億美元，這得益於價格上漲和需求成長。對於五年適應症，我們已向 FDA 提交了申請，準備在 FDA 批准後於 2025 年底推出。

Fertility had a very strong quarter, growing nearly 26% globally. The US grew $23 million or 70%, with about half of the growth coming from lapping a buyout in Q1 of last year. The other half was volume growth and rate favorability. Ex-US fertility grew 4%, with new launches in Turkey and Japan offsetting sluggish performance in China.

本季生育率表現非常強勁，全球生育率成長近 26%。美國成長了 2,300 萬美元，即 70%，其中約一半的成長來自去年第一季的收購。另一半是交易量成長和利率有利性。美國以外的生育率成長了 4%，土耳其和日本的新產品上市抵消了中國市場的低迷表現。

We expect growth in the US as well as footprint expansion outside the US to drive high single-digit growth in our global fertility business in 2025. Jada grew 20% in the quarter, driven by growth in shipments, especially in the US among existing customers that are expanding Jada adoption. More than 94% of the nation's largest birthing hospitals now stock Jada.

我們預計，美國國內的成長以及美國以外地區的擴張將推動我們 2025 年全球生育業務實現高個位數成長。本季度，Jada 成長了 20%，這得益於出貨量的成長，尤其是美國現有客戶正在擴大 Jada 的採用。目前，全國 94% 以上的大型婦產科醫院均已配備 Jada。

During the first quarter, Jada launched in South Korea and achieved the CE Mark of approval in Europe. We plan to launch in select EU markets this year, and we continue to assess future market expansion opportunities.

第一季度，Jada 在韓國上市，並在歐洲獲得 CE 標誌認證。我們計劃今年在部分歐盟市場推出產品，並將繼續評估未來的市場擴張機會。

Turning to biosimilars. Biosimilars continues to be an important part of our growth story. In 2025, though Ontruzant and Remflexis will continue to decline, Hadlima grew 57% in the first quarter with continued strong uptake in the US We also recently acquired the regulatory and commercial rights for Tofidence in the US for intravenous infusion. Tofidence is the first biosimilar approved for Actemra.

轉向生物相似藥。生物相似藥仍然是我們成長故事的重要組成部分。2025 年，儘管 Ontruzant 和 Remflexis 將繼續下滑，但 Hadlima 在第一季成長了 57%，並且在美國繼續保持強勁成長。我們最近也收購了 Tofidence 在美國用於靜脈輸液的監管和商業權利。Tofidence 是第一個核准的 Actemra 生物相似藥。

Tofidence was launched in May 2024, but the overall Actemra biosimilar market was slow to form in the US yielding an opportunity, a very good opportunity for future sales uptake and growth. Immunology is a market we certainly know well in the US, notably the physician-administered business, and as a result, we are uniquely positioned to drive Tofidence sales. And finally, we anticipate launching the portfolio of Henlius products beginning in late 2025 with the denosumab biosimilar in the US followed by pertuzumab in Europe.

Tofidence 於 2024 年 5 月推出，但美國 Actemra 生物相似藥市場整體形成緩慢，這為未來的銷售成長帶來了機遇，非常好的機會。我們非常了解美國免疫學市場，尤其是由醫生管理的業務，因此，我們在推動 Tofidence 銷售方面具有獨特的優勢。最後，我們預計將於 2025 年底開始推出 Henlius 產品組合，首先在美國推出地舒單抗生物相似藥，然後在歐洲推出帕妥珠單抗。

Wrapping up the revenue discussion with established brands, in the respiratory portfolio, mandatory pricing revisions in Japan and mild seasonal respiratory complications in China weighed on their results in the first quarter. Performance in the cardiovascular portfolio during the first quarter was driven by the headwinds from the loss of exclusivity of Atozet, which will abate in the fourth quarter of this year.

總結與知名品牌的收入討論，在呼吸產品組合中，日本的強制性價格調整和中國的輕微季節性呼吸系統並發症對其第一季的業績產生了影響。第一季心血管產品組合的表現受到 Atozet 失去獨家經營權的不利影響，但這種影響將在今年第四季減弱。

As we have said since then, though many of the brands in this portfolio have been around for decades, we have taken an entrepreneurial approach in managing the business for profitable growth. The Established Brands franchise is starting to look different than it did at spin, now home to innovative medicines that are growth engines for the company, it looks more like a general medicines portfolio.

正如我們從那時起所說的那樣，儘管該投資組合中的許多品牌已經存在了幾十年，但我們採取了企業家的方式來管理業務，以實現盈利增長。成熟品牌特許經營權開始看起來與分拆時有所不同，現在它是公司成長引擎的創新藥物的所在地，看起來更像是通用藥物組合。

Over the last year and a half, we have added products with patent protection to this franchise, including Emgality and Vtama. Combined, we expect those products to generate over $300 million in revenue in 2025.

在過去的一年半里，我們為這個特許經營權增加了具有專利保護的產品，包括 Emgality 和 Vtama。我們預計這些產品到 2025 年將產生超過 3 億美元的收入。

The Vtama launch performance has been encouraging. As it continues to outpace branded competition in NRx and TRx growth. For the week ending April 18, Vtama NRX grew 71% versus direct competitors who were up 4% compared to a pre-AD approval 13-week average baseline. TRx grew 30% compared with competitors who were up 5%.

Vtama 的發售表現令人鼓舞。因為它在 NRx 和 TRx 成長方面繼續超越品牌競爭對手。截至 4 月 18 日當週，Vtama NRX 增長了 71%，而直接競爭對手與 AD 批准前 13 週的平均基線相比僅增長了 4%。TRx 成長了 30%，而競爭對手的成長率為 5%。

Vtama is uniquely positioned within the atopic dermatitis market. It is applied once-a-day and it is the only nonsteroidal topical approved for mild, moderate, and severe atopic dermatitis, providing access to all segments of the addressable market. It is the only product approved for patients two years of age and older, offering a significant advantage over competitors.

Vtama 在異位性皮膚炎市場中佔據獨特的地位。本產品每日使用一次，是唯一獲準用於治療輕度、中度和重度異位性皮膚炎的非類固醇用藥物，可進入所有目標市場。它是唯一獲準用於兩歲及以上患者的產品，比競爭對手具有顯著優勢。

We have developed a core capability in finding opportunities like Emgality and Vtama. These are accretive transactions with deal structures heavily weighted towards success-based milestones. These are the types of assets that over time, we will have greater opportunity to pursue with the capital freed up from the dividend.

我們已經發展出尋找 Emgality 和 Vtama 等機會的核心能力。這些是增值交易，其交易結構主要側重於基於成功的里程碑。隨著時間的推移，我們將有更多機會利用股息釋放的資本來追求這些類型的資產。

I'll now turn the call over to Matt, who will review the financials in more detail.

我現在將電話轉給馬特，他將更詳細地審查財務狀況。

Thank you, Kevin. Beginning on Slide 9, here we bridge the 4% constant currency revenue decline in the first quarter year-over-year. Starting on the left, LOE was about $60 million for the quarter, which primarily reflects the impact of the loss of exclusivity of Atozet in Europe, which occurred in September 2024. VBP in China was de minimis in the first quarter, and we expect only a nominal impact on a full year basis for 2025.

謝謝你，凱文。從第 9 張投影片開始，我們在此彌補了第一季同比 4% 的恆定貨幣收入下降。從左邊開始，本季的 LOE 約為 6,000 萬美元，這主要反映了 2024 年 9 月 Atozet 在歐洲失去獨家經營權的影響。第一季度，中國的 VBP 微乎其微，我們預計 2025 年全年的影響僅很小。

Our potential exposure this year will be more back-half weighted as we expect Fosamax will be included in round 11. Once this occurs, approximately 80% of our Established Brands portfolio will have been subjected to the VBP process.

由於我們預計 Fosamax 將在第 11 輪中被納入，因此我們今年的潛在風險敞口將更多地集中在後半部分。一旦發生這種情況，我們大約 80% 的成熟品牌組合將接受 VBP 流程的審查。

There was an approximate $40 million impact from price for the first quarter, or about 2.5%. Pricing pressure was mainly from biosimilars, certain mature products in the US, like NuvaRing and Dulera, and the LOE of Atozet.

第一季的價格影響約為 4,000 萬美元，約佔 2.5%。定價壓力主要來自生物相似藥、美國某些成熟產品，如 NuvaRing 和 Dulera，以及 Atozet 的 LOE。

From a regional perspective, we continue to face expected mandatory pricing revisions in Japan and ongoing competitive price pressures related to our respiratory products in China. Volumes increased $45 million in the quarter, representing growth of a little over 2.5%. Hadlima, Emgality, Vtama, and Nexplanon were the largest contributors to volume growth and will likely continue to be the main drivers for the full year.

從區域角度來看，我們繼續面臨日本預期的強制性定價調整以及中國呼吸產品持續的競爭價格壓力。本季交易量增加了 4,500 萬美元，增幅略高於 2.5%。Hadlima、Emgality、Vtama 和 Nexplanon 是銷量成長的最大貢獻者，並可能繼續成為全年的主要推動力。

In supply or other, here we capture 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 $45 million impact in the first quarter or about 280 basis points of headwind to revenue, which reflects a strengthening US dollar versus most foreign currencies in the current period relative to the first quarter of 2024. The recent weakening of the US dollar potentially creates a tailwind for us over the remainder of 2025, and I'll revisit this point later in the presentation when we discuss guidance.

在供應或其他方面，我們在這裡捕捉到了與默克公司達成的利潤較低的合約製造安排，自分拆以來，這些安排一直在下降，正如預期的那樣。最後，外匯折算在第一季產生了約 4,500 萬美元的影響，或對收入造成約 280 個基點的阻力，這反映了本期美元兌大多數外幣相對於 2024 年第一季的走強。美元近期的疲軟可能會為我們在 2025 年剩餘時間內帶來順風，我將在稍後的演講中討論指導意見時再次討論這一點。

Now let's turn to Slide 10, where we show key non-GAAP P&L line items and metrics for the quarter. For reference, GAAP financials and reconciliations to the non-GAAP financial measures are included in our press release and the slides in the appendix of this presentation. For gross profit, we are excluding from cost of goods sold, purchase accounting amortization and one-time items, which can be seen in our appendix slides.

現在讓我們翻到投影片 10，其中展示了本季的關鍵非 GAAP 損益項目和指標。作為參考，我們的新聞稿和本簡報附錄中的投影片包含 GAAP 財務資料和與非 GAAP 財務指標的對帳。對於毛利，我們排除了銷售成本、採購會計攤銷和一次性項目，這些都可以在我們的附錄幻燈片中看到。

Adjusted gross margin was 61.7% for the first quarter compared with 62.1% in the first quarter of 2024. The year-over-year decrease in adjusted gross margin primarily reflects the impact of unfavorable price, as I discussed. Non-GAAP SG&A expense was up 6% in the first quarter, driven by commercial and launch expenses for Vtama, which was acquired in the fourth quarter of 2024. Excluding expenses related to Vtama, SG&A was down versus prior year, reflective of our efforts to contain and reduce operating expenses.

第一季調整後毛利率為 61.7%，而 2024 年第一季為 62.1%。正如我所討論的，調整後毛利率的年減主要反映了不利價格的影響。第一季非公認會計準則銷售、一般及行政費用上漲 6%，主要原因是 2024 年第四季收購的 Vtama 的商業和發布費用。不包括與 Vtama 相關的支出，銷售、一般及行政費用較上年有所下降，這反映了我們為控制和減少營運支出所做的努力。

Non-GAAP R&D expense before $6 million of IPR&D was down 17%, primarily due to the timing of clinical study spend. As we think about the restructuring actions to reduce operating expense that we communicated as part of our 2025 earnings guidance in February, we began executing those plans during the first quarter, and we fully expect to achieve approximately $200 million in expense savings over quarters two through four, which is already incorporated into our earnings guidance.

600 萬美元知識產權與開發 (IPR&D) 之前的非公認會計準則研發費用下降了 17%，這主要是由於臨床研究支出的時間表。當我們考慮在 2 月作為 2025 年獲利預測的一部分傳達的降低營運費用的重組行動時，我們在第一季度就開始執行這些計劃，並且我們完全預計在第二季度至第四季度實現約 2 億美元的費用節省，這已經納入我們的盈利預測中。

Our first quarter adjusted EBITDA margin of 32% was about 150 basis points better than we expected, in part because of the timing of clinical study spend that I just spoke of. We also did a bit better on gross margin, driven by favorable product mix. Also in the first quarter, we benefited from a $4 million realized transaction gain from foreign exchange, mainly driven by currencies that we can't hedge.

我們第一季調整後的 EBITDA 利潤率為 32%，比我們預期的高出約 150 個基點，部分原因是我剛才提到的臨床研究支出的時機。由於良好的產品組合，我們的毛利率也略有增加。此外，在第一季度，我們從外匯交易中獲得了 400 萬美元的收益，這主要歸功於我們無法對沖的貨幣。

Turning to Slide 11, we delivered $146 million of free cash flow before one-time costs in the first quarter, about a third better than the prior year period. This is a function of active cash cycle working capital management, lower interest rates, and timing of cash interest and tax payments.

翻到第 11 張投影片，我們在第一季實現了 1.46 億美元的一次性成本前的自由現金流，比去年同期高出約三分之一。這是積極的現金週期營運資本管理、較低利率以及現金利息和稅金支付時間的功能。

As we said back in February, one-time costs related to the spin-off were completed in 2024 following the rollout of our global ERP system. We expected one-time spin-off costs to be zero in 2025, and you can see that reflected in our first quarter results against $62 million in the prior year period.

正如我們二月所說的那樣，與分拆相關的一次性成本將在 2024 年我們推出全球 ERP 系統後完成。我們預計 2025 年一次性分拆成本將為零，您可以從第一季的業績中看到這一點，而去年同期成本為 6,200 萬美元。

In the $75 million of other one-time costs, about $15 million relates to cash payments associated with restructuring initiatives aimed at leaning out our operating expense, as I mentioned earlier, $20 million relates to the final payment on the Microspherix settlement, and the remaining $40 million relates to the planned exits from supply arrangements with Merck that, as we've discussed in past quarters, would be ramping up.

在 7500 萬美元的其他一次性成本中，約有 1500 萬美元與旨在削減運營費用的重組計劃相關的現金支付有關，正如我之前提到的，2000 萬美元與 Microspherix 和解的最終付款有關，剩餘的 4000 萬美元與計劃退出與默克的供應安排有關，正如我們在前幾個季度所討論的那樣，這些安排將增加的那樣，這些安排將增加。

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 能夠重新定義我們適當的採購策略，並轉向適合用途的供應鏈，同時專注於提高毛利率擴張方面的效率，我們預計這一目標將在 2027 年開始實現。

Restructuring and manufacturing separation activities could together represent $325 million to $375 million in 2025. Our current view is that we could finish 2025 at the lower end of this range. Once again, these one-time costs drive value that investors will be able to see in 2025 in the form of improved operating expense efficiency and in later years related to more cost-efficient manufacturing that is expected to drive meaningful margin expansion.

到 2025 年，重組和製造分離活動的總價值可能達到 3.25 億至 3.75 億美元。我們目前的看法是，到 2025 年，我們的業績可能會處於這一範圍的低端。再次，這些一次性成本推動的價值將使投資者能夠在 2025 年以營運費用效率提高的形式看到，並在以後幾年中與更具成本效益的製造相關，預計這將推動利潤率的大幅擴張。

In 2025, we expect to pay about $200 million in commercial milestones, primarily tied to Vtama, Emgality, in the biosimilar programs with Shanghai Henlius. Through the first quarter, we have paid about $130 million towards that expected amount.

2025 年，我們預計將支付約 2 億美元的商業里程碑費用，主要與上海復宏漢霖的生物相似藥計畫 Vtama、Emgality 相關。截至第一季度，我們已支付約 1.3 億美元以實現預期金額。

The achievement of these milestones means that we are realizing value for business development deals already signed and validates the path to low to mid single-digit revenue growth post 2025 that we've been saying Organon should be able to deliver.

這些里程碑的實現意味著我們正在實現已簽署的業務發展協議的價值，並驗證了我們一直認為 Organon 應該能夠實現的 2025 年後低至中等個位數收入增長的道路。

Now turning to Slide 12. Our net leverage ratio was 4.3 times at March 31. That performance is consistent with prior commentary that leverage could float up to the mid-4 times area during 2025 as we digest the Dermavant transaction. As we capture more EBITDA benefit from the Vtama launch later in the year and realize the benefit of operating expense restructuring actions, we would naturally delever closer to 4.2 times where we ended 2024.

現在翻到投影片 12。截至3月31日，我們的淨槓桿率為4.3倍。這一表現與先前的評論一致，即隨著我們消化 Dermavant 交易，槓桿率可能在 2025 年上升至 4 倍中間區域。隨著我們在今年稍後從 Vtama 的推出中獲得更多 EBITDA 收益，並實現營運費用重組行動的好處，我們自然會將槓桿率降低至接近 2024 年底的 4.2 倍。

With our revised capital allocation plan announced today that increases our retention ratio, we now have the ability to accelerate progress on deleveraging. In the near term, as Kevin stated, our priority is to reduce net leverage, given the uncertain macroeconomic environment that investors are reacting to.

我們今天宣布了修訂後的資本配置計劃，提高了我們的留存率，現在我們有能力加快去槓桿的進程。正如凱文所說，短期內，鑑於投資者面臨的不確定的宏觀經濟環境，我們的首要任務是降低淨槓桿。

We see a clear path to achieving net leverage below 4 times by year-end. And over time, the capital preserved with a higher retention ratio creates a compounding improvement in financial flexibility. It offers us the opportunity to achieve meaningful deleveraging over the next few years, whether it's through outright debt repayment, accretive M&A, or some combination of the two.

我們看到了到年底實現淨槓桿率低於 4 倍的明確途徑。隨著時間的推移，以更高的留存率保留的資本會創造財務彈性的複合改善。它為我們提供了在未來幾年實現有意義的去槓桿的機會，無論是透過直接償還債務、增值併購，還是兩者結合。

Now turning to 2025 guidance on Slide 13. For the operational bars on this page, everything remains the same for the full year. Our constant-currency guidance remains the same, which is about flat versus prior year at the midpoint.

現在轉到第 13 張投影片上的 2025 年指引。對於此頁面上的營運欄，全年一切都保持不變。我們的固定匯率指引維持不變，與去年同期的中間值基本持平。

We expect the uptake of Vtama, continued solid performance in Emgality, and organic growth in Nexplanon and other products in our portfolio will help to offset the LOE of Atozet in Europe along with pricing headwinds in other parts of the portfolio. That's a pretty strong statement, given that Atozet's LOE represents a headwind of approximately $200 million alone between volume and price.

我們預期 Vtama 的普及、Emgality 的持續穩健表現以及 Nexplanon 和我們產品組合中其他產品的有機成長將有助於抵消 Atozet 在歐洲的 LOE 以及產品組合中其他部分的定價阻力。這是一個相當有力的聲明，因為 Atozet 的 LOE 代表著在數量和價格之間約 2 億美元的逆風。

So, with no changes to the ranges on the operational drivers, let's focus for a moment on foreign exchange. The guidance we provided in February was for an expected $200 million negative impact from FX in 2025 or about a 300 basis point headwind.

因此，在營運驅動因素範圍沒有變化的情況下，讓我們暫時關注外匯。我們在二月提供的指導是，預計 2025 年外匯將造成 2 億美元的負面影響，或約 300 個基點的逆風。

As I mentioned, the Q1 impact was about 280 basis points, in line with that full year estimate. Since February, however, the dollar has weakened. And if current rates persist, we would see some upside to the full year estimate that would move us to the high end of the guidance range.

正如我所提到的，第一季的影響約為 280 個基點，與全年估計一致。然而，自二月以來，美元已經走弱。如果目前的利率持續下去，我們將看到全年預測上調，這將使我們達到指導範圍的高端。

Given the volatility in the currency markets, that upside could be temporary. The responsible thing to do at this point as regards guidance is to avoid chasing a very volatile currency market and for now leave that component of our guidance unchanged and simply note the possibility for favorability over the remainder of the year. We'll be reevaluating our view on FX as the year progresses.

鑑於貨幣市場的波動性，這種上漲可能是暫時的。就指導而言，目前負責任的做法是避免追逐非常動蕩的貨幣市場，目前保持指導的這一部分不變，並僅注意今年剩餘時間內有利的可能性。隨著時間的推移，我們將重新評估對外匯的看法。

From a quarterly phasing perspective, we should deliver modest sequential revenue growth from the first quarter to the second quarter, and we continue to expect the fourth quarter to be the strongest of the year.

從季度分階段來看，我們應該會在第一季到第二季實現適度的連續收入成長，並且我們仍然預計第四季度將是今年最強勁的季度。

Turning to Slide 14, where we show all components of our earnings guidance. Again, no changes to what we provided back in February. We expect adjusted gross margin to be in the range of 60% to 61%, about a one point lower at the midpoint compared with last year. And that's a continuation of the pressure on gross margin that we saw in 2024, especially in the back half due to price and higher manufacturing and distribution costs.

翻到投影片 14，我們展示了獲利預測的所有組成部分。再次強調，我們二月提供的內容沒有任何變化。我們預計調整後的毛利率將在 60% 至 61% 之間，與去年相比中間值下降約一個百分點。這是我們在 2024 年看到的毛利率壓力的延續，尤其是在下半年，由於價格以及製造和分銷成本的上升。

On SG&A expense, we ended 2024 at 25% of revenue, and R&D was about 7% of revenue ex-IPR&D. Those general percentages also hold for 2025. And that guidance implies essentially flat OpEx dollars year-over-year, which is consistent with ongoing actions to improve our operating cost efficiency that would serve as offsets to investments to grow Vtama. Those pieces culminate in an adjusted EBITDA margin range of 31% to 32%. The favorability we saw in Q1 adjusted EBITDA margin was mostly timing.

就銷售、一般及行政費用而言，截至 2024 年，我們的銷售、一般及行政費用佔營收的 25%，而研發費用約佔不含智慧財產權及研發收入的 7%。這些總體百分比也適用於 2025 年。該指引意味著營運支出與去年同期基本持平，這與我們為提高營運成本效率而採取的持續行動一致，這些行動將抵消對 Vtama 發展的投資。這些因素最終使調整後的 EBITDA 利潤率達到 31% 至 32%。我們在第一季調整後的 EBITDA 利潤率中看到的有利因素主要是時機。

Second quarter adjusted EBITDA margin should look very similar to what Q1 would have looked like without the upside that came through. So, that means we're expecting a Q2 adjusted EBITDA margin in the 30.5% area. We continue to believe Q4 will have the highest margin for the full year as Vtama ramps and we capture more of the benefit of our restructuring initiatives.

第二季調整後的 EBITDA 利潤率應該與第一季非常相似，如果沒有出現上漲趨勢。因此，這意味著我們預計第二季調整後的 EBITDA 利潤率將在 30.5% 左右。我們仍然相信，隨著 Vtama 的成長以及我們從重組舉措中獲得更多收益，第四季度的利潤率將是全年最高的。

For below the line items, our estimate for full year 2025 interest expense remains at $510 million, which includes about $25 million related to the debt-like instruments assumed in the Dermavant acquisition. Payments on a portion of those instruments are tied to Vtama sales.

對於以下項目，我們對 2025 年全年利息支出的估計仍為 5.1 億美元，其中包括與 Dermavant 收購中承擔的債務類工具相關的約 2,500 萬美元。部分工具的付款與 Vtama 銷售掛鉤。

Exclusive of the Dermavant transaction, our interest expense estimate for 2025 is approximately $30 million lower compared with last year as a result of the two refinancing events completed in 2024 and lower borrowing rates on our variable rate debt instruments.

不包括 Dermavant 交易，由於 2024 年完成的兩次再融資活動以及我們的浮動利率債務工具的借款利率較低，我們對 2025 年的利息支出估計比去年低約 3000 萬美元。

For 2025, we continue to estimate our non-GAAP tax rate to be in the range of 22.5% to 24.5%. 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 is a touch higher than last year at $135 million, driven by the completion of our new ERP system in 2024.

到 2025 年，我們繼續估計我們的非 GAAP 稅率將在 22.5% 至 24.5% 之間。2024年以後的上漲主要是受經合組織第二支柱規定的15%全球最低稅率的影響。由於我們新的 ERP 系統將於 2024 年完工，折舊額比去年略高，為 1.35 億美元。

In summary, first quarter performance was solid and puts us squarely on track to meet our financial guidance for the year. Nexplanon, our largest product, posted another quarter of double-digit revenue growth. Our largest acquisition, Vtama, is launching nicely and is on track to deliver the $150 million in 2025 revenue that we forecasted, and we continue to make steady progress on the $200 million of identified operating expense savings in 2025, which would deliver our best operating expense efficiency metrics since the spin-off.

總而言之，第一季的業績表現穩健，使我們有望實現今年的財務目標。我們最大的產品 Nexplanon 本季的營收再次實現兩位數成長。我們最大的收購項目 Vtama 進展順利，預計將實現我們預測的 2025 年 1.5 億美元的收入，並且我們將繼續穩步推進 2025 年 2 億美元的已確定營運費用節省目標，這將實現我們自分拆以來最好的營運費用效率指標。

We expect these OpEx savings to benefit not only 2025, but annualized to roughly $275 million, which we would realize in 2026 and thereafter. And finally, the change we are making to our capital allocation priorities to increase our retention ratio will enable us to accelerate meaningful strengthening of our balance sheet, including lowering our 2025 net leverage ratio target to sub-4 times by the end of the year.

我們預計這些營運支出的節省不僅會在 2025 年帶來好處，而且年化後將達到約 2.75 億美元，我們將在 2026 年及以後實現這一目標。最後，我們對資本配置重點所做的改變，以提高我們的留存率，將使我們能夠加速有意義的資產負債表強化，包括到今年年底將 2025 年淨槓桿率目標降低至 4 倍以下。

With that, now let's turn the call over to Q&A.

好了，現在讓我們進入問答環節。

(Operator Instructions)

（操作員指示）

David Amsallem from Piper Sandler.

派珀‧桑德勒 (Piper Sandler) 的戴維‧阿姆薩勒姆 (David Amsallem)。

Hi, thanks. So, a couple for me. First on Vtama, can you just talk through your level of confidence that you can get to that sales target that you reiterated? And I guess part of my question here is, just given the nature of the category and that it is tightly controlled, how are you feeling about access?

你好，謝謝。所以，對我來說是一對。首先關於 Vtama，您能否談談您對實現您重申的銷售目標的信心程度？我想我的問題的一部分是，考慮到類別的性質以及嚴格控制，您對訪問有何看法？

How are you feeling about the gross to net here? Just help us understand in just overall how you think you can get to the target. That's number one. And then number two, just with your priorities regarding deleveraging, where does additional BizDev M&A fit? Is that on the back burner? Is that something where you're just going to continue to be opportunistic? How should we think about that? Thank you.

您對這裡的總淨額有何感想？只需幫助我們從整體上了解您認為如何才能達到目標。這是第一點。第二，就您關於去槓桿的優先事項而言，額外的 BizDev 併購適合什麼？那是暫時擱置的事嗎？您是否還會繼續抓住機會？我們該如何看待這個問題？謝謝。

Thanks for the question, David. It's Kevin. And in regards to Vtama, we are confident that we'll achieve that $150 million that I kept mentioning. And the reason for that is that the new label, the atopic dermatitis label, really is a game-changer.

謝謝你的提問，大衛。我是凱文。關於 Vtama，我們有信心實現我一直提到的 1.5 億美元目標。原因在於，新標籤，即異位性皮膚炎標籤，確實改變了遊戲規則。

The kind of advantages that we have versus competition are significant, whether it's essentially the once-a-day down to two years of age, the incredible efficacy in terms of attacking itch, which is the number one essentially symptom that you see with AD, it's been and the initial reports have been fantastic, not only that, but you see the NRx and TRx numbers.

我們相對於競爭對手的優勢非常顯著，無論是每天一次的給藥劑量，還是兩歲以下兒童服用的劑量，還是在治療瘙癢方面的驚人功效，瘙癢是 AD 的首要症狀，初步報告非常出色，不僅如此，您還可以看到 NRx 和 TRx 數字。

But you put your finger on probably the most important aspect of getting to that number, which is access. And we've got a fantastic managed care group, working on access as we speak right now. And I think all the things that I'm seeing in terms of signals are coming from the market is essentially getting really good uptake in regards to moving the needle on and getting more covered lives, moving prior off to essentially preferred and non-preferred, and just moving that whole continuum over.

但你可能已經指出了獲得這個數字的最重要的方面，那就是訪問權。我們有一個優秀的管理式醫療小組，目前正在致力於提供醫療服務。我認為，我所看到的所有訊號都來自市場，這些訊號基本上在推動發展、覆蓋更多生命、從優先和非優先轉向推動整個連續體方面得到了很好的接受。

And that is the key point underpinning my confidence in being able to reach that $150 million. I was in the field actually doing double visits last week, and in three different cities in the states, and I what I can tell you is there's been a lot of momentum and a lot of good positive feedback right now because now patients are coming back after they've been prescribed the drug and kind of seeing follow-up, and what they're saying signaling to me has been outstanding efficacy and really easy to apply.

這是我對於能夠達到 1.5 億美元目標充滿信心的關鍵。實際上，上週我在美國三個不同的城市進行了兩次訪問，我可以告訴你的是，現在有很多發展勢頭和很多積極的反饋，因為現在患者在開藥後會回來並進行後續治療，他們告訴我，這種藥物療效顯著，而且非常容易使用。

So, we feel good about that. And ultimately, when we reach that number, we'll have a different discussion in terms of what the future outlook looks like because we're going to be launching in Canada later actually in a few months coming and we'll be launching ex-US in terms of international and globalizing this product. We feel very good about this acquisition.

因此，我們對此感到很高興。最終，當我們達到這個數字時，我們將對未來前景進行不同的討論，因為我們實際上將在幾個月後在加拿大推出該產品，並且我們將在美國以外推出該產品的國際和全球化產品。我們對這次收購感到非常高興。

And in regards to the second question about deleveraging, yes, that's what we're focused on right now. We think it's the right thing to do, as Matt said, sub four by the end of the year and then accelerating that going forward. And then ultimately over time, what we think this is going to do is essentially it's going to strengthen the company's future prospects. As we start to delever, we'll be able to kind of look for opportunities down the road in terms of being able to bring in more assets like Vtama into the organization.

關於第二個問題，關於去槓桿，是的，這是我們現在關注的重點。我們認為這是正確的做法，正如馬特所說，在今年年底前達到 4 個，然後加速推進。最終，隨著時間的推移，我們認為這將從本質上增強公司的未來前景。當我們開始去槓桿時，我們將能夠尋找機會，為組織引入更多像 Vtama 這樣的資產。

Look, we need products like that. We've got a fantastic business development organization that really has developed a real skill set at being able to identify assets that we can bring into our hands and ultimately plug into our commercial organization and do a really good job with.

看，我們需要這樣的產品。我們擁有一個出色的業務發展組織，該組織確實已經開發出一套真正的技能，能夠識別我們可以掌握的資產，並最終將其納入我們的商業組織並真正出色地完成工作。

So, for right now, it's really focused on delevering. And then over time, it's really focused on being able to bring in other assets like a Vtama or Tofidence that we just brought in that have fantastic opportunities and are accretive almost immediately.

因此，就目前而言，它的重點是去槓桿。然後隨著時間的推移，它真正專注於引入其他資產，例如我們剛剛引入的 Vtama 或 Tofidence，它們具有絕佳的機會並且幾乎可以立即增值。

Okay. Thank you.

好的。謝謝。

Yes, Dave.

是的，戴夫。

Michael Nedelcovych with TD Cowen.

TD Cowen 的 Michael Nedelcovych。

Thank you for the question. I have one question and a follow-up. So, clearly, BD will be more of a focus moving forward. Should we think of any uptick in that area as an increase in the frequency of future deals, or could there also be an increase in the size of future deals?

謝謝你的提問。我有一個問題和一個後續問題。因此，顯然，BD 將成為未來更加關注的焦點。我們是否應該將該領域的任何上漲視為未來交易頻率的增加，或者未來交易規模是否也會增加？

And as a follow-up, when we survey the assets that Organon has been licensed recently, I think it's fair to say the company has adopted a pretty flexible definition of women's health. So, what should we consider to be your option space moving forward? Is there any asset or therapeutic category that you view as outside the bounds of your strategic focus, or is pretty much everything fair game so long as it makes financial sense? Thank you.

作為後續行動，當我們調查 Organon 最近獲得許可的資產時，我認為可以公平地說，該公司對女性健康採取了相當靈活的定義。那麼，我們應該考慮您未來的選擇空間是什麼？您是否認為某些資產或治療類別超出了您的策略重點範圍，或者只要具有財務意義，幾乎所有資產或治療類別都是公平的？謝謝。

Thanks for the question, Michael. I would say this that we have a very broad definition of women's health, first and foremost. It encompasses, I would say, three accesses. One is those conditions unique to women, like for example our Forendo acquisition, of which we'll be talking about the more down the road in terms of what we're doing in that space for endometriosis or polycystic ovary syndrome.

謝謝你的提問，麥可。我想說的是，首先，我們對女性健康的定義非常廣泛。我想說，它包含三個入口。一是女性特有的疾病，例如我們收購的 Forendo，我們將在以後詳細討論我們在子宮內膜異位症或多囊性卵巢症候群領域所做的工作。

Our partnership with Lilly on Emgality, two-thirds of the patients who suffer and struggle with migraine are women, which are those conditions, I would call it, disproportionately impacting women. And then the third category would be I would say, fall into the category where Vtama falls in, which is dermatology, specifically AD where it affects women differently, whether it's the fact that women happen to be the caregivers by and large.

我們與禮來公司在 Emgality 上的合作表明，患有偏頭痛並與之抗爭的患者中有三分之二是女性，我認為這種疾病對女性的影響尤其嚴重。然後我想說，第三類是屬於 Vtama 所屬的類別，即皮膚病學，特別是 AD，它對女性的影響不同，無論是否事實上女性恰好是大部分護理人員。

And so, in the pediatric space, there's nothing there that ultimately approaches from a non-steroidal perspective, patients that are two years of age and older. And by the way, we are getting started this year on studying this product for down to three months of age and older. So, that's a game-changer.

因此，在兒科領域，從非類固醇角度來看，沒有任何藥物可以治療兩歲及以上的患者。順便說一下，我們今年開始研究針對三個月及以上嬰兒的產品。所以，這是一個改變遊戲規則的事件。

And from that point of view, I mean, when you look at adults, adults typically suffer more from AD that are women than men. And so, that is kind of the more squishy, I would say, of the three definitions. But typically, we are looking at a broader perspective, but also we have a very business-oriented mindset in regards to getting assets that we feel that we're a better owner of, that we can do better with globally, whether it's plugging it into our international commercial footprint or whether it's essentially using our medical affairs teams or commercial assets teams.

從這個角度來看，我的意思是，當你觀察成年人時，女性罹患 AD 的幾率通常比男性更大。所以，我想說，這是三種定義中比較模糊的一種。但通常情況下，我們會從更廣闊的視角來看待問題，但我們也具有非常商業導向的思維方式，以獲得我們認為自己更適合擁有的資產，我們可以在全球範圍內做得更好，無論是將其插入我們的國際商業足跡，還是本質上利用我們的醫療事務團隊或商業資產團隊。

So, I think, overall, we're making the right use of capital, and our BD organization is doing a really good job of setting up these deals, so that it's not just a one hit where it's essentially success-based, everybody has got skin in the game, and we're paying milestones along the way. We're happy to pay those milestones because it just basically means that we're hitting on some of those achievements in terms of commercial achievements.

因此，我認為，總的來說，我們正在正確使用資本，我們的 BD 組織在建立這些交易方面做得非常好，因此它不僅僅是一次性的成功，它本質上是基於成功的，每個人都參與其中，我們在此過程中支付里程碑費用。我們很樂意支付這些里程碑，因為這基本上意味著我們在商業成就方面取得了一些成就。

In regards to whether it's more frequent smaller deals or larger deals, again, like I said, the key thing is delevering. And when we find the deal, the right deal like a Vtama, for example, or Tofidence that we just brought in, we'll do that, but it just gives us more room to breathe when we have a much lower leverage rate, and we'll continue to accelerate that.

至於是更頻繁地進行小額交易還是更大規模交易，正如我所說，關鍵在於去槓桿。當我們找到交易時，例如 Vtama 或我們剛剛引入的 Tofidence 這樣的正確交易，我們就會這樣做，但當我們擁有更低的槓桿率時，它給了我們更多的喘息空間，我們將繼續加速這一進程。

Take the next question.

請回答下一個問題。

Chris Schott with JPMorgan.

摩根大通的 Chris Schott。

Hi. This is Ethan on for Chris Schott. Thanks for taking our questions. On the first question, just wanted to ask about capital allocation more broadly in your framework going forward. And maybe more specifically, how share repo might fit into that equation relative to debt paydown and business development? And then my second question is just on the potential impact of tariffs.

你好。這是 Ethan 為 Chris Schott 上場。感謝您回答我們的問題。關於第一個問題，我只是想更廣泛地詢問您未來框架中的資本配置問題。也許更具體地說，股票回購如何適應債務償還和業務發展之間的等式？我的第二個問題是關於關稅的潛在影響。

I know you provided some commentary on 2025. But any general color on your ability to navigate this dynamic looking past 2025, although details are lacking, maybe just frame out how you're thinking about that impact? Thank you.

我知道您對 2025 年發表了一些評論。但是，儘管缺乏細節，但對於您在 2025 年之後如何應對這種動態的能力，您有什麼總體看法嗎？也許可以概括一下您對這種影響的看法？謝謝。

Yeah, Ethan, I think Matt and I will ping-pong on addressing these topics. So, I'll keep the tariff issue aside for Matt to deal with. But on capital allocation, really briefly, right, look, we're doing this I want to be clear. We're doing this from a position in terms of what we've done with the dividend today what we announced from a position of strength.

是的，伊桑，我想馬特和我會就這些問題進行討論。因此，我將把關稅問題放在一邊，讓馬特來處理。但關於資本配置，真的簡而言之，對，看，我們正在這樣做，我想清楚一點。我們這樣做是基於我們今天對股息的處理，這是我們從強勢地位宣布的。

Over the last few years, we have, for example, reestablished Nexplanon where our key product, where we're going to surpass a $1 billion this year. We have stabilized the Established Brands business. We have essentially grown regrown our fertility business. We have also successfully launched Jada and Hadlima and Emgality and now Vtama and Tofidence.

例如，在過去幾年裡，我們重新建立了 Nexplanon 作為我們的主要產品，今年其銷售額將超過 10 億美元。我們已經穩定了成熟品牌業務。我們的生育業務已從根本上重新發展。我們也成功推出了 Jada、Hadlima 和 Emgality，現在又推出了 Vtama 和 Tofidence。

And so, we're very comfortable with the fact that going forward, some of the headwinds we faced this year with a loss of exclusivity or of our second-largest product out of that will be behind us. And essentially, going forward, we have opportunities really to accelerate our top line and bottom line growth. And so for that and we've done three restructurings in the last year and a half. So, we're a much more leaner, fit-for-purpose organization.

因此，我們對未來感到非常放心，今年我們面臨的一些不利因素，例如失去獨家經營權或第二大產品等，都將成為過去。從本質上講，展望未來，我們確實有機會加速我們的營收和利潤成長。為此，我們在過去一年半中進行了三次重組。因此，我們是一個更精簡、更適合用途的組織。

This is really done in order to be able to set us up, so that in the future, we can do more business development deals like the Vtama and the other Tofidence deal that we just did recently in order to be able to continue to grow, continue to grow for the long term. And so, I believe this is a position of strength.

這樣做實際上是為了讓我們做好準備，以便將來我們可以進行更多的業務發展交易，例如我們最近剛完成的 Vtama 和另一項 Tofidence 交易，以便能夠繼續增長，繼續長期增長。所以，我相信這是一個強勢地位。

And when it comes now to your second question around tariffs, I'll hand that over to Matt in terms of in regards to the fact that what we see today is not something that we feel very concerned about, but

現在談到你關於關稅的第二個問題，我會把它交給馬特，因為我們今天看到的情況並不是我們非常擔心的事情，但是

Yes. Yes. Thank you, Kevin. So, as we spoke of in the prepared comments, where the policy is more clear around countries like Canada, Mexico, China, we have very nominal exposure, less than $5 million in 2025 and it's one of the factors that has enabled us to affirm guidance for the year.

是的。是的。謝謝你，凱文。因此，正如我們在準備好的評論中提到的那樣，加拿大、墨西哥、中國等國家的政策更加明確，我們的風險敞口非常小，2025 年的風險敞口不到 500 萬美元，這是我們能夠確認年度指導的因素之一。

When you look forward, Organon has six manufacturing plants, all of them outside the United States. Most of the production that ends up coming into the United States is from our plants in Europe. And since the policy around there around that route into the United States is still very fluid, it's really too soon to be talking about what potential impacts might be.

展望未來，Organon 擁有六家製造工廠，全部位於美國境外。最終進入美國的大部分產品都來自我們位於歐洲的工廠。由於進入美國的路線政策仍非常不穩定，現在談論可能的影響還為時過早。

Do you want to address share buybacks that he had mentioned earlier, Ethan?

伊森，你想談談他之前提到的股票回購問題嗎？

Sure. So, share buybacks have been a lower priority for us on our roster of capital allocation priorities. The biggest issues we face that can improve Organon's valuation in the near term relate to managing our leverage and relate to growth.

當然。因此，在我們的資本配置優先事項中，股票回購的優先順序較低。我們面臨的最大問題在於管理我們的槓桿並與成長有關，這些問題可以在短期內提高 Organon 的估值。

And we need capital to solve both of those issues. And so, returning capital to shareholders is right now less of a priority. It's one of the reasons why we made the move that we did with the dividend announcement today. So and especially as long as our leverage is above 4 times, I believe we'll create more value and better positioning and overall strength for the future by rightsizing our leverage versus buying back shares.

我們需要資金來解決這兩個問題。因此，向股東返還資本現在不再是當務之急。這就是我們今天宣布派發股息的原因之一。因此，特別是只要我們的槓桿率高於 4 倍，我相信透過調整槓桿率而不是回購股票，我們將為未來創造更多價值、更好的定位和整體實力。

Umer Raffat with Evercore ISI.

烏默·拉法特 (Umer Raffat) 與 Evercore ISI。

Hi, guys. Thanks for taking my question. I mean, look, I feel like the Dermavant deal was a surprise, but today is a bigger surprise, and there's a lot of market sentiment that they can't have confidence in consistency and decision-making process at Organon right now.

嗨，大家好。感謝您回答我的問題。我的意思是，你看，我覺得 Dermavant 交易是一個驚喜，但今天的驚喜更大，而且市場情緒很強烈，他們現在對 Organon 的一致性和決策過程沒有信心。

So, specifically, last call, you guys said you're committed to regular dividend as the number one capital allocation priority. I think you just now said returning capital is a lower priority. And I guess the question is really for all the investors on the line, what is the priority? And how can we be sure that this will be the priority going forward because there appears to be a lot of things just moving around constantly?

因此，具體來說，最後一次，你們說你們致力於將定期股利作為首要的資本配置優先事項。我認為您剛才說過返還資本的優先順序較低。我想，真正的問題是，對於所有投資者來說，優先事項是什麼？鑑於似乎有很多事情在不斷變化，我們如何確定這將是未來的優先事項？

Well, Umer, thanks for the question. And as if you noticed, things are going on in the outside, macroenvironment is changing. It's quite volatile out there. Clearly, investment community is not clearly focused on the dividend for us as much as it is on leverage.

好吧，Umer，謝謝你的提問。正如你所注意到的，外面的事情正在發生，宏觀環境正在改變。那裡的情況相當不穩定。顯然，投資界並不十分關注我們的股息，而是關注槓桿。

I hear it in almost every discussion that I have with investors that they're very concerned about where we are in terms of leverage in these very volatile times, it's really a risk-off type of analysis.

幾乎在與投資者的每次討論中，我都會聽到他們非常關心我們在這些非常動蕩的時期的槓桿情況，這實際上是一種避險類型的分析。

So, for us, we're very committed to that. But when we saw the type of volatility happening, we saw the timing, we're on the verge of really having, I think, a really great year in 2026 and the second half of this year, I think we're in a much better position to say, look, we know that we can delever very quickly.

所以，對我們來說，我們非常致力於此。但是，當我們看到波動類型的發生時，我們看到了時機，我認為我們即將迎來真正偉大的 2026 年和今年下半年，我認為我們處於更有利的位置，可以說，看，我們知道我們可以很快去槓桿。

And as we delever and as we have a situation where we give ourselves more of an opportunity to bring in assets like Vtama, and I will tell you that right now, if you just look at the NRx and TRxs of Vtama, it's clearly positive signaling to the fact that we made the right decision, and hopefully, we'll be able to have a discussion at the end of the year where you see that we delivered what we said we were going to deliver with the product, and ultimately, then you see the run rate of where we're going with this product and the type of label we're developing was a good use of capital. And I think there's a better use of capital in bringing in more assets in that space.

隨著我們去槓桿，我們給自己更多機會引入像 Vtama 這樣的資產，我現在要告訴你，如果你只看 Vtama 的 NRx 和 TRxs，這顯然是一個積極的信號，表明我們做出了正確的決定，希望我們能夠在年底進行一次討論，屆時你會看到我們兌現了我們承諾的產品，最終，你會看到我們正在利用這款開發的標誌性資本。我認為，在該領域引入更多資產可以更好地利用資本。

And so, the combination of what's happening externally, coupled with where investors essentially are kind of telling us that they're very focused on delevering, much more so than anything else, kind of brought us to the fact and the initial encouraging results we're really having with Vtama and the continued strength of our core products like Nexplanon tells us that there's a better use of that capital in terms of being able to go forward and use it to be able to not only delever, but bring in growth aspects for the company.

因此，外部發生的各種情況，再加上投資者基本上告訴我們，他們非常注重去槓桿，而不是其他任何事情，都讓我們認識到一個事實，即 Vtama 最初取得的令人鼓舞的成果以及我們核心產品（如 Nexplanon）的持續強勁表現告訴我們，可以更好地利用這些資本，不僅可以去槓桿，還可以為公司帶來增長。

Thank you for that, Kevin. And maybe just to clarify then, is part of your thought process in anticipation for tariffs given your manufacturing network, or was it exclusively from deleveraging perspective?

謝謝你，凱文。那麼，也許只是為了澄清一下，考慮到你們的製造網絡，你們的思考過程是否部分考慮了關稅，還是完全從去槓桿的角度考慮？

Well, right now, we don't know where we're pretty well set for where the tariffs are today. Let's see where they land in the US. It's very early to be able to determine exactly what that's going to look like. But I think we're pretty good for 2025.

嗯，現在我們還不知道今天的關稅是多少。讓我們看看他們會在美國哪裡降落。現在還無法準確判斷其具體是什麼樣子。但我認為，2025 年我們的成績相當不錯。

We brought in a lot of the inventory that as I said, we manage the inventory of our biggest product, Nexplanon, but the focus really is on deleveraging right now. And I think that, as I said, volatile times, investors being very clear with us, we need to delever, accelerate that process kind of took us to where we took that decision, not lightly, but I think very clear-minded.

我們引進了大量庫存，正如我所說，我們管理著我們最大的產品 Nexplanon 的庫存，但現在的重點確實是去槓桿。我認為，正如我所說的，在動盪時期，投資者對我們非常清楚，我們需要去槓桿，加速這一進程，這讓我們做出了這個決定，雖然不是輕率的，但我認為是非常清醒的。

Thank you.

謝謝。

Jason Gerberry with Bank of America.

美國銀行的 Jason Gerberry。

Hi, guys. This is Bhavin Patel on for Jason. Two questions from us. First, what are your views on the Nexplanon Paragraph IV? Do you see the filer as a credible threat to launching generic in ex-US markets? And where does the FDA stand on the issue of applicator similarity, which I believe was the core issue in your Citizens petition?

嗨，大家好。我是 Bhavin Patel，取代 Jason。我們有兩個問題。首先，您對Nexplanon第四段有何看法？您是否認為該申請人對在美國以外市場推出仿製藥構成了可信的威脅？FDA 對施藥器相似性議題的立場為何？我認為這是公民請願書中的核心問題。

And then my second question is regarding the expected $900-plus millions of free cash flow before one-time costs. Can you break down the anticipated one-time costs for 2025? And how should we think about free cash flow both before and after one-time costs in 2026? Thank you.

我的第二個問題是關於一次性成本之前預計的9億多美元的自由現金流。您能分解一下 2025 年預計的一次性成本嗎？我們該如何看待2026年一次性成本之前和之後的自由現金流？謝謝。

Why don't we address those questions in reverse order, Matt, why don't you deal with the cash flow issues one-time cost and then maybe you want Camilo, you can address the paragraph 4 issue, which is US by the way, yeah.

為什麼我們不以相反的順序來解決這些問題，馬特，你為什麼不處理現金流問題的一次性成本，然後也許你想要卡米洛，你可以解決第 4 段的問題，順便說一下，這是我們的問題，是的。

Yes. So, with regards to this fiscal year, in the included in our estimates for one-time costs, it's about $150 million in round numbers related to the manufacturing separation from Merck. Recall that the one-time cost of separation on the administrative side for things like TSA activities, that number is zero.

是的。因此，就本財政年度而言，在我們對一次性成本的估計中，與默克製造業務分離相關的整數約為 1.5 億美元。回想一下，對於 TSA 活動等行政方面的一次性分離成本，這個數字是零。

From a restructuring perspective, we were looking at something in the vicinity of $200 million to achieve the operating expense savings of $200 million this year, annualizing to $275 million. And then there's about $75 million of other costs, which I elucidated in the prepared comments.

從重組的角度來看，我們希望今年能節省 2 億美元的營運費用，年化後達到 2.75 億美元。然後還有大約 7500 萬美元的其他費用，我在準備好的評論中對此進行了闡述。

Now as we look forward to 2026 and really beyond, we will continue to have manufacturing separation costs for the next few years. This year is probably the largest. It will be gradually declining. And then what we will start to see is the back-end milestone payments for BD deals already signed that will probably be in the $200 million to maybe $250 million range going forward. But thankfully, the further we get from the spin-off, the less of an impact these various one-time costs are making.

現在，當我們展望 2026 年及以後時，未來幾年我們將繼續承擔製造分離成本。今年可能是規模最大的一年。將會逐漸下降。然後我們將開始看到已經簽署的 BD 交易的後端里程碑付款，未來可能在 2 億美元到 2.5 億美元之間。但值得慶幸的是，我們距離分拆越遠，這些一次性成本的影響就越小。

And then I'll ping pong with Juan Camilo in regards to the question on the Paragraph IV. It's not a surprise to us. And the legal process that, that's going to go through will take us anyway through probably mid-2027. We still have a patent that needs to be determined in regards to legal process in regards to our applicator.

然後，我將與胡安·卡米洛就第四段的問題進行交流。這對我們來說並不奇怪。無論如何，這項法律程序可能會持續到 2027 年中期。我們仍然有一項專利需要根據我們的施藥器的法律程序來確定。

We feel very confident that, that's a fairly strong patent that takes us through 2030 and the issues in terms of regulatory process of being able to get the FDA approval in regards to actually having a three year, remember, we're launching five-year indication later this year.

我們非常有信心，這是一項相當強大的專利，可以讓我們持續到 2030 年，而就監管流程而言，我們能夠獲得 FDA 批准，實際上擁有三年的期限，請記住，我們將在今年晚些時候推出五年期的適應症。

So there'll be if they overcome all the significant large obstacles, which nobody has been able to do yet with the FDA on large, then they'll be coming into the market that's already moved to a five-year indication. But I'll move it over to Juan Camilo to discuss in regards to some of the difficult regulatory difficulties around trying to get an approval for a product like this.

因此，如果他們能克服所有重大障礙，而目前還沒有人能夠與 FDA 達成這一目標，那麼他們就能進入已經進入五年適應症的市場。但我會將其交給胡安·卡米洛 (Juan Camilo) 來討論有關嘗試獲得此類產品批准的一些棘手的監管難題。

Yes. Thank you, Kevin. And thank you, Jason. The complexity of getting a generic lag it's been highlighted multiple times, it is multiple fold. First is the demonstration of equivalent. There is the need for bioequivalence.

是的。謝謝你，凱文。謝謝你，傑森。獲得通用滯後的複雜性已被強調多次，它是多倍的。首先是等價性的論證。需要進行生物等效性研究。

The current draft guidance from FDA for six months but it's been shown in the past that six months of bioequivalent does not translate into three years of efficacy. Therefore, that's one of the challenges that I be going to have to decide how much the how confident they are on the efficacy side.

FDA 目前的指導草案為六個月，但過去的經驗表明，六個月的生物等效性並不等同於三年的療效。因此，這是我要面臨的挑戰之一，決定他們對療效有多大信心。

Then you mentioned the applicator that gets to the safety. The FDA is really focused on the safety of the insertion and removal of in funds like this, any changes to the applicator, open the door for really questioning the safety of a new device, and the requirements for training, for restricted distribution, for certification of physicians before they can use their products.

然後你提到了達到安全效果的塗抹器。FDA 真正關注的是此類資金插入和移除的安全性，對施用器的任何改變，都為真正質疑新設備的安全性打開了大門，並且對培訓、限制分發、醫生使用其產品前的認證要求也提出了要求。

So there is complexity all throughout, so FDA will have to now go through this review and we've highlighted this very clearly multiple aspects of this in detail in our citizen petition because we know how complex it is because we've been doing it for many, many, many years to ensure the safety of NEXPLANON.

所以整個過程都很複雜，所以 FDA 現在必須進行這項審查，我們在公民請願書中非常清楚地詳細地強調了這方面的多個方面，因為我們知道這有多複雜，因為我們已經這樣做了很多年，以確保 NEXPLANON 的安全。

So we see that there is a very, very high bar, not only from a legal perspective on the IP of the rod and the applicator but also the regulatory bar for FDA to be confident on the efficacy and safety of a new product. So as Kevin pointed out, we continue to be very, very confident in our ability to grow NEXPLANON all the way at the end of the decade, and we're excited about the potential for a five year indication coming way before the end of the year.

因此，我們看到，不僅從法律角度對棒和塗抹器的智慧財產權有很高的要求，而且從監管角度對 FDA 對新產品的功效和安全性也有很高的要求。因此，正如凱文所指出的，我們仍然非常有信心在 2020 年底實現 NEXPLANON 的全面發展，並且我們對在今年年底之前實現五年期適應症的可能性感到興奮。

Thank you.

謝謝。

This concludes the question-and-answer session and will conclude today's conference call and webcast. We 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。感謝您的加入。您現在可以斷開連線。