使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Hello, and welcome to the Organon fourth quarter and full year 2025 earnings call and webcast. (Operator Instructions).
大家好,歡迎參加 Organon 2025 年第四季及全年財報電話會議和網路直播。(操作說明)
I would now like to turn the conference over to Jennifer Halchak, Vice President, Investor Relations. You may begin.
現在我將把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。
Jennifer Halchak - Investor Relations
Jennifer Halchak - Investor Relations
Thank you, operator. Good morning, everyone. With me today are Joe Morrissey, Organon's Interim Chief Executive Officer; and Matt Walsh, our Chief Financial Officer; Carrie Cox, Organon's Board Chair; and Juan Camilo Arjona Ferreira, Organon's Head of R&D, will also be joining for the Q&A portion of this call.
謝謝接線生。各位早安。今天與我一同出席的有 Organon 的臨時執行長 Joe Morrissey;財務長 Matt Walsh;Organon 的董事會主席 Carrie Cox;以及 Organon 的研發主管 Juan Camilo Arjona Ferreira,他們也將參加本次電話會議的問答環節。
Today, we are 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 Organon Investor Relations website. Please reference slides 2 and 3 for a couple of brief reminders.
今天,我們將介紹一份演示文稿,參加我們網路直播的各位可以在本次通話期間看到它。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,其中包含一些簡單提醒。
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, believe, future, estimates, believes, outlook and other words of similar meaning. 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. This includes our most recent Form 10-K and Forms 10-Q and those amended forms.
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、展望等詞語以及其他類似含義的詞語。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 10-K 表格和 10-Q 表格以及這些修訂後的表格。
These statements are based on information as of today, February 12, 2026 and except as required by law, Organon undertakes no obligation to update or revise any of these forward-looking statements. 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 the current report on Form 8-K.
這些聲明是基於截至 2026 年 2 月 12 日的信息,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。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,並且已在當前的 8-K 表格報告中提交給美國證券交易委員會。
I note that while our full year 2026 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 legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and acquisition-related expenses. These items are uncertain, depend on various factors and could be material to our results computed in accordance with GAAP.
我注意到,雖然我們2026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努力的情況下,合理確定地預測法律訴訟的最終結果、異常收益和損失、產生GAAP稅務影響的不合理事項的發生以及與收購相關的費用。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。
I'd now like to turn the call over to Joe Morrissey.
現在我想把電話交給喬莫里西。
Joseph Morrissey - Interim Chief Executive Officer, Executive Vice President, Head - Manufacturing and Supply
Joseph Morrissey - Interim Chief Executive Officer, Executive Vice President, Head - Manufacturing and Supply
Thank you, Jen. Beginning on slide 4. In 2025, Organon delivered $6.2 billion in revenue and $1.9 billion of adjusted EBITDA. Revenue was down 3% on both a reported and ex exchange basis. Relative to where we began the year, our biosimilar franchise performed better than expected, driven by solid performance in Hadlima as well as contributions from new launches.
謝謝你,珍。從第4張投影片開始。2025 年,Organon 的營收為 62 億美元,調整後 EBITDA 為 19 億美元。無論以報告匯率或以匯率變動計算,收入均下降了3%。與年初相比,我們的生物相似藥業務表現超出預期,這主要得益於 Hadlima 的穩健表現以及新產品的上市。
Vtama delivered $128 million of global revenue in 2025 and Emgality and our fertility business also grew strongly in 2025. That performance helped to offset the continued impact of the LOE of Atozet and headwinds in other parts of the business that emerged during the year. Those include policy-related changes in the US for Nexplanon and a revision to medical guidelines in certain international markets that deprioritize the use of montelukast, which impacted Singulair. Though Nexplanon had its challenges this year, the FDA approved our sNDA to extend the duration of Nexplanon from three to five years.
Vtama 在 2025 年實現了 1.28 億美元的全球收入,Emgality 和我們的生育業務在 2025 年也實現了強勁成長。這項業績有助於抵消 Atozet 的持續營運影響以及年內其他業務領域出現的不利因素。這些變化包括美國針對 Nexplanon 的政策變化,以及某些國際市場對醫療指南的修訂,降低了孟魯司特的使用優先級,這對 Singulair 產生了影響。儘管 Nexplanon 今年遇到了一些挑戰,但 FDA 批准了我們的補充新藥申請,將 Nexplanon 的使用期限從三年延長至五年。
The study supporting the approval enrolled a population of women with varying body mass indices, including women with overweight or obesity, a testament to Organon's commitment to inclusive and comprehensive women's healthcare. This is a meaningful milestone for Organon and the Nexplanon brand as it potentially broadens the addressable market for this key product. The approval also includes a new risk evaluation and mitigation strategy program that will enhance Organon's existing clinical training program and controlled distribution program, which has been in place since 2006.
支持這項批准的研究招募了不同體重指數的女性,包括超重或肥胖的女性,證明了 Organon 致力於提供包容性和全面的女性醫療保健。這對 Organon 和 Nexplanon 品牌來說是一個意義重大的里程碑,因為它有可能擴大這個關鍵產品的潛在市場。此次批准還包括一項新的風險評估和緩解策略計劃,該計劃將加強 Organon 自 2006 年以來一直實施的現有臨床培訓計劃和受控分銷計劃。
One of the most important decisions the company made in 2025 was to lower our dividend payout ratio and apply those excess funds to debt reduction. We also divested the Jada system, resulting in approximately $390 million in net proceeds that will help us to reduce net debt in 2026. Together, these decisions mark our commitment to improving capacity in Organon's balance sheet to put us in a position to pursue growth opportunities in the future. At the same time, we have scrutinized our spending and had to consider tough but necessary changes to our business.
公司在 2025 年做出的最重要的決定之一是降低股息支付率,並將多餘的資金用於償還債務。我們也剝離了 Jada 系統,獲得了約 3.9 億美元的淨收益,這將有助於我們在 2026 年減少淨債務。這些決定共同標誌著我們致力於改善 Organon 的資產負債表,使我們能夠在未來抓住成長機會。同時,我們仔細審查了支出情況,並不得不考慮對業務進行艱難但必要的變革。
In 2025, we were able to keep adjusted EBITDA margins essentially flat with 2024, despite 150 basis points of gross margin degradation. We achieved over $200 million in cost savings in 2025 through significant efforts, which offset investments in growth drivers like Vtama. We also discontinued early-stage clinical programs and are limiting spend to activities such as medical and regulatory affairs that support products already in the market.
2025 年,儘管毛利率下降了 150 個基點,但我們仍能夠使調整後的 EBITDA 利潤率與 2024 年基本持平。我們透過大量努力,在 2025 年實現了超過 2 億美元的成本節約,這抵消了對 Vtama 等成長驅動因素的投資。我們也停止了早期臨床項目,並將支出限制在支援已上市產品的醫療和監管事務等活動中。
As we look across the portfolio, we expect revenue and adjusted EBITDA this year to be very much in line with 2025, which means at a high level, we expect to deliver about $6.2 billion of revenue and about $1.9 billion of adjusted EBITDA in 2026. We expect that the annual revenue foregone with the sale of the Jada system will be offset by an FX tailwind of about the same amount, which means we expect revenue to be about flat with prior year on a constant currency basis, pro forma for the Jada system divestiture.
從整體投資組合來看,我們預計今年的營收和調整後 EBITDA 將與 2025 年基本持平,這意味著總體而言,我們預計 2026 年的營收將達到約 62 億美元,調整後 EBITDA 將達到約 19 億美元。我們預計,出售 Jada 系統所損失的年度收入將被大致相同金額的外匯利好所抵消,這意味著,按固定匯率計算,在不考慮 Jada 系統剝離的情況下,我們預計收入將與上一年基本持平。
On the profitability front, we continue to thoughtfully curtail OpEx to offset what we believe is about 75 to 100 basis points of deterioration in gross margin in 2026 and that we can manage to an adjusted EBITDA figure of about $1.9 billion.
在獲利能力方面,我們繼續謹慎地削減營運支出,以抵消我們認為 2026 年毛利率將下降約 75 至 100 個基點的影響,並且我們可以將調整後的 EBITDA 控制在約 19 億美元。
I remain confident in our ability to deliver these results in 2026, and I'm deeply proud of the talented teams across Organon who are driving this work every day.
我對我們在 2026 年實現這些目標的能力仍然充滿信心,並且我為 Organon 各個才華橫溢的團隊感到無比自豪,他們每天都在推動這項工作。
With that, I hand it over to Matt.
說完,我把它交給了馬特。
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
Thank you, Joe. Beginning on slide 5, let's talk about the main drivers of performance in women's health. Women's health was down 16% ex FX for the fourth quarter and down 2% for the year. Sales of Nexplanon decreased 20% ex FX in the fourth quarter and 4% for the full year, in line with what we discussed in November when we re-guided on the product. As we've talked about in previous quarters, in 2025, Nexplanon was impacted by several headwinds.
謝謝你,喬。從第5張投影片開始,我們來談談影響女性健康表現的主要因素。第四季女性健康指數(不計匯率影響)下降了 16%,全年下降了 2%。第四季 Nexplanon 的銷售額(不計匯率因素)下降了 20%,全年下降了 4%,這與我們 11 月重新發布該產品業績指引時所討論的情況一致。正如我們在前幾季討論的那樣,2025 年,Nexplanon 受到了幾個不利因素的影響。
Let's break it down between those we expect to continue versus those that we believe are onetime in nature. And starting with the onetime item. As we talked about last quarter, we expected an approximate $17 million negative impact in the fourth quarter related to the cessation of certain identified US wholesaler sales practices identified in the Audit Committee's internal investigation disclosed in late October. The impact from that practice is contained to 2025.
讓我們來區分一下我們預期會持續發生的事情和我們認為只會發生一次的事情。首先從一次性物品開始。正如我們上個季度所討論的那樣,我們預計第四季度將出現約 1700 萬美元的負面影響,這與審計委員會在 10 月下旬披露的內部調查中發現的某些美國批發商銷售行為的停止有關。此做法的影響僅限於 2025 年。
Now what do we think is likely to persist in 2026. We see 4 drivers. The first driver is in the US and is macro in nature. Government policy-related access restrictions have impacted planned parenthood and federally qualified health centers where Nexplanon has a leading market share among LARCs, incorporated in our guidance is that this policy environment persists in 2026.
那麼,我們認為哪些因素可能會在2026年繼續存在呢?我們看到4名司機。第一個驅動因素來自美國,本質上是宏觀層面的。政府政策相關的准入限制影響了計劃生育和聯邦合格的醫療中心,而 Nexplanon 在 LARC 中佔據了領先的市場份額。我們的指導方針中也提到,這種政策環境在 2026 年仍然存在。
The second driver. In 2025, we saw a developing weakness with smaller independent commercial clinics who are tightly managing their buy-and-bill purchasing with some choosing to switch to specialty pharmacy claims for each patient via assignment of benefits. While we expect this change to remain, we are actively engaging customers in this segment to support sustained and improved access to Nexplanon.
第二位司機。2025 年,我們看到小型獨立商業診所的弱點日益顯現,這些診所嚴格管理其購買和結算採購,有些診所選擇透過福利分配的方式,為每位患者轉為專科藥房索賠。雖然我們預計這種變化會持續下去,但我們正在積極與該領域的客戶溝通,以支持持續和改善對 Nexplanon 的獲取。
Third driver. As we've discussed previously, in 2026, we will have a volume headwind from loss of reinsertions as we transition to the five-year label. Fourth and final driver is an offsetting positive. We expect strong ex US growth to compensate for the US, particularly in Latin America, where we are seeing improved access.
第三位司機。正如我們之前討論過的,到 2026 年,隨著我們過渡到五年標籤制度,由於再插入次數的減少,我們將面臨銷量下滑的不利因素。第四個也是最後一個驅動因素是抵消性的正面因素。我們預計除美國以外的強勁成長將彌補美國的不足,尤其是在拉丁美洲,我們看到那裡的市場准入正在改善。
Turning to fertility. Our fertility business declined 6% ex FX in the fourth quarter of 2025, primarily related to sales performance in China, where we are holding share, but socioeconomic trends are weighing on the broader fertility market. For the full year, the fertility business grew 8% ex FX, driven by performance in the US, particularly in the first half of 2025 as well as geographic footprint expansion which together offset declines in China.
轉而討論生育問題。2025 年第四季度,我們的生育業務(不計匯率)下降了 6%,主要與我們在中國的銷售業績有關,我們在中國擁有市場份額,但社會經濟趨勢對更廣泛的生育市場構成壓力。全年來看,不計匯率因素,生育業務成長了 8%,這主要得益於美國市場的良好表現,尤其是在 2025 年上半年,以及地域範圍的擴大,這兩者共同抵消了中國市場的下滑。
Fertility will likely be a headwind for us in 2026 as we expect an increasingly competitive environment in the US brought on by a competitor's agreement with the administration's new Direct Access Program. And finally, the Jada system delivered $74 million of revenue in 2025. We completed the divestiture of Jada in January of this year. So that will represent a headwind of about 120 basis points to Organon's consolidated revenue in 2026.
2026 年,生育率可能會成為我們的一大不利因素,因為我們預計,由於競爭對手與政府新的直接准入計畫達成協議,美國市場競爭將日益激烈。最後,Jada 系統在 2025 年實現了 7,400 萬美元的收入。我們在今年一月完成了對 Jada 的剝離。因此,這將對 Organon 2026 年的合併收入造成約 120 個基點的不利影響。
Turning now to biosimilars on slide 6. For the fourth quarter and full year, the drivers in biosimilars are largely the same. Performance was driven by Hadlima, which grew 61% ex FX globally for the full year, reflecting the strong clinical profile of Hadlima and the effectiveness of our pricing strategy as well as expansion into Canada and Puerto Rico.
現在就來看看第 6 張投影片中的生物類似藥。第四季和全年,生物相似藥的驅動因素基本上相同。Hadlima 的業績成長是主要驅動力,其全年全球銷售額(不含匯率影響)成長了 61%,這反映了 Hadlima 強大的臨床表現、我們定價策略的有效性以及在加拿大和波多黎各的擴張。
To a lesser extent, biosimilars also benefited from our new denosumab biosimilars, which were approved by the FDA in August and launched in the US in late September, and Tofidence, which the company acquired in the second quarter of 2025. In 2026, we expect biosimilars to deliver flat to modest growth with Hadlima and the contribution of new assets expected to at least offset the expected decline in Ontruzan and Renflexis, consistent with the maturity of those assets. As regards to future launches, we've entered into a settlement with Genentech that grants us a license to start launching our pertuzumab biosimilar asset in UCAN in 2027 and in the US in 2028.
生物相似藥也在一定程度上受益於我們的新型地諾單抗生物相似藥(於 8 月獲得 FDA 批准,並於 9 月下旬在美國上市)以及公司於 2025 年第二季度收購的 Tofidence。2026 年,我們預計生物相似藥將實現平穩或溫和增長,Hadlima 和新資產的貢獻預計至少可以抵消 Ontruzan 和 Renflexis 的預期下滑,這與這些資產的成熟度相符。關於未來的產品上市,我們已與基因泰克達成和解,和解協議授予我們許可,允許我們在 2027 年於加拿大、2028 年在美國推出我們的帕妥珠單抗生物相似藥產品。
Wrapping up the franchise discussion with established brands on slide 7. Established brands revenue declined 5% ex FX in the fourth quarter of 2025 as well as for the full year. We've always said that the CAGR in established brands should be about flat ex FX and with some years above and some years below.
在第 7 張投影片上,我們總結了關於成熟品牌的特許經營討論。2025 年第四季及全年,知名品牌營收(不計匯率因素)均下降 5%。我們一直認為,成熟品牌的複合年增長率(不計匯率影響)應該基本上持平,有些年份高於平均水平,有些年份低於平均水平。
In 2025, we navigated through the LOE of Atozet, which itself was an approximate 400 basis point headwind to established brands revenue. In 2026, we expect to return to flat performance. Contributions from Vtama and Emgality together with lapping the LOE of Atozet, should offset expected continued pressure in our respiratory franchise.
2025 年,我們克服了 Atozet 的 LOE(上市時間限制),這本身對成熟品牌的收入造成了約 400 個基點的不利影響。我們預計到 2026 年,業績將恢復穩定。Vtama 和 Emgality 的貢獻,加上 Atozet 的 LOE 到期,應該可以抵消我們呼吸系統產品線預計持續面臨的壓力。
Turning now to the fourth quarter revenue bridge on slide 8. Revenue in the fourth quarter was $1.57 billion, down 8% at constant currency. Loss of exclusivity was about $20 million in the quarter, the lowest of the year and was related to lapping the Atozet LOE in the EU, which occurred in September of 2024. VBP was negligible for the quarter. Organon products were not included in any new rounds of China's national VBP program during 2025.
現在來看第 8 頁投影片上的第四季營收銜接部分。第四季營收為15.7億美元,以固定匯率計算下降8%。本季獨家經營權的損失約為 2,000 萬美元,是今年以來的最低水平,這與 Atozet 在歐盟的獨家經營權到期有關,該到期發生在 2024 年 9 月。本季VBP微乎其微。2025 年,Organon 產品沒有被納入中國國家價值導向支付計畫的任何新一輪計畫。
We lost approximately $80 million on price in the fourth quarter. About $30 million of this was related to four separate gross to net adjustments that were onetime in nature. The remainder was primarily driven by pricing revisions in respiratory, expected competitive pricing pressures in fertility and biosimilars and the LOE of Atozet.
第四季我們在價格方面損失了約 8000 萬美元。其中約 3000 萬美元與四項一次性總額到淨額的調整有關。其餘部分主要受呼吸系統藥物價格調整、生育和生物相似藥領域預期競爭價格壓力以及 Atozet 的剩餘有效期所驅動。
Additionally, there was an increase in the US rebate rate for Nexplanon in the quarter related to a change in patient mix tied to Medicaid usage claims. Volume declined about $10 million in the quarter, and that was mainly driven by lower volume for Nexplanon and in the respiratory portfolio, which was largely offset by volume growth in Vtama, Hadlima, Emgality and Arcoxia.
此外,由於與醫療補助使用索賠相關的患者組成變化,本季美國 Nexplanon 的回扣率有所上升。本季銷量下降了約 1000 萬美元,這主要是由於 Nexplanon 和呼吸系統產品組合的銷量下降所致,但 Vtama、Hadlima、Emgality 和 Arcoxia 的銷量增長在很大程度上抵消了這一影響。
In Supply 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 $35 million favorable impact for the quarter, which reflects the weaker US dollar against the majority of foreign currencies in which we transact.
在「其他供應」中,我們記錄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,這些協議一直在減少。最後,外匯折算在本季度產生了約 3500 萬美元的有利影響,這反映了美元對我們交易的大多數外幣走弱。
Let's look at these same drivers now on a full year basis on slide 9. Loss of volume from LOE was about $200 million, consistent with the range we've outlined all year and that was primarily related to the LOE of Atozet in the EU. As I mentioned, there was essentially no VBP impact in 2025. There was about $180 million of negative impact from price in 2025 or about 2.8%.
現在讓我們在第 9 張投影片上,以全年為單位來看這些相同的驅動因素。LOE造成的銷售損失約2億美元,與我們全年概述的範圍一致,這主要與歐盟Atozet的LOE有關。正如我之前提到的,VBP 在 2025 年基本上沒有產生任何影響。到 2025 年,價格將產生約 1.8 億美元的負面影響,約佔 2.8%。
Pricing headwinds for the full year were primarily in the respiratory portfolio with rate pressure in the US for Dulera and mandatory price reductions in China for Nasonex and Singulair. To a lesser extent, we also felt price impacts stemming from the competitive environment in biosimilars and fertility in the US. Volume grew $200 million in 2025 or 3% for the year with contributions from Vtama and Emgality and growth in fertility and biosimilars, offsetting declines in the global respiratory portfolio and Nexplanon in the US.
全年價格上漲的主要阻力來自呼吸系統藥物組合,包括美國 Dulera 的價格壓力以及中國 Nasonex 和 Singulair 的強制降價。我們在某種程度上也感受到了美國生物相似藥和生育領域競爭環境帶來的價格影響。2025 年銷售量成長 2 億美元,年成長 3%,這主要得益於 Vtama 和 Emgality 的貢獻,以及生育和生物相似藥的成長,抵消了全球呼吸系統產品組合和美國 Nexplanon 的下滑。
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 purchase accounting and amortization and onetime items from cost of goods sold, which can be seen in our appendix slides. Non-GAAP adjusted gross margin was 56.7% for the fourth quarter of 2025 compared to 60.6% in the fourth quarter of 2024.
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,GAAP財務數據以及與非GAAP財務指標的調節表已包含在我們的新聞稿和本次簡報的附錄投影片中。對於毛利,我們從銷售成本中剔除了採購會計處理、攤銷和一次性項目,這可以在我們的附錄幻燈片中看到。2025 年第四季非 GAAP 調整後毛利率為 56.7%,而 2024 年第四季為 60.6%。
Pricing pressure and unfavorable product mix were notable drivers in the decline of non-GAAP adjusted gross margin. Adjusted gross margin for the full year 2025 was 60.1% compared with 61.6% for the full year 2024, with pricing pressure being the primary unfavorable driver in the year. Non-GAAP adjusted EBITDA margin was 25.4% in the fourth quarter of 2025 compared with 28.1% in the fourth quarter of 2024.
價格壓力和不利的產品組合是導致非GAAP調整後毛利率下降的顯著因素。2025 年全年調整後毛利率為 60.1%,而 2024 年全年為 61.6%,價格壓力是該年度的主要不利因素。2025 年第四季非 GAAP 調整後 EBITDA 利潤率為 25.4%,而 2024 年第四季為 28.1%。
The year-over-year decline in the fourth quarter 2025 adjusted EBITDA margin was primarily driven by the lower adjusted gross margin that was partially offset by a 5% reduction in non-GAAP operating expenses. Adjusted EBITDA margin was 30.7% for full year 2025, consistent with prior year as the decline in adjusted gross margin was substantially offset by lower R&D expense.
2025 年第四季調整後 EBITDA 利潤率年減,主要是由於調整後毛利率下降所致,但非 GAAP 營運費用下降 5% 部分抵銷了這一影響。2025 年全年調整後 EBITDA 利潤率為 30.7%,與上年持平,因為調整後毛利率的下降被研發費用的減少大幅抵銷。
Net loss for the fourth quarter of 2020 was $205 million or $0.79 per diluted share compared with net income of $109 million or $0.42 per diluted share in the fourth quarter of 2024. Net loss for the fourth quarter of 2025 includes a noncash goodwill impairment of $301 million or $1.16 per share related to the decline in the company's stock price and underperformance in the US.
2020 年第四季淨虧損 2.05 億美元,即每股攤薄虧損 0.79 美元,而 2024 年第四季淨利為 1.09 億美元,即每股攤薄利潤 0.42 美元。2025 年第四季淨虧損包括 3.01 億美元或每股 1.16 美元的非現金商譽減損,這與該公司股價下跌和在美國業績不佳有關。
For the fourth quarter of 2025, non-GAAP adjusted net income was $165 million or $0.63 per diluted share compared with $235 million or $0.90 per diluted share in 2024. Non-GAAP adjusted net income was $954 million for full year 2025 or $3.66 per share compared with $1.065 billion or $4.11 per share in full year 2024.
2025 年第四季,非 GAAP 調整後淨收入為 1.65 億美元,即每股攤薄收益 0.63 美元,而 2024 年同期為 2.35 億美元,即每股攤薄收益 0.90 美元。2025 年全年非 GAAP 調整後淨收入為 9.54 億美元,即每股 3.66 美元,而 2024 年全年為 10.65 億美元,即每股 4.11 美元。
Turning to free cash flow now on slide 11. For full year 2025, we delivered $960 million of free cash flow before onetime costs, consistent with prior year. 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 which were together about $270 million for 2025.
現在來看第 11 頁的自由現金流。2025 年全年,我們在扣除一次性成本前實現了 9.6 億美元的自由現金流,與前一年持平。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。剩下的工作是提高利潤率的重組和製造分離活動,預計到 2025 年這些活動的總投資額約為 2.7 億美元。
For 2026, we expect costs associated with manufacturing separation activities to be about $100 million. We do expect an increase in CapEx associated with these activities as well as an increase in net working capital consumption driven largely by inventory in established brands and biosimilars, which means our free cash flow in 2026 will likely resemble what we delivered in both 2024 and 2025.
預計到 2026 年,與製造分離活動相關的成本約為 1 億美元。我們預計與這些活動相關的資本支出將會增加,淨營運資本消耗也會增加,這主要是由於成熟品牌和生物相似藥的庫存增加所致,這意味著我們 2026 年的自由現金流可能與 2024 年和 2025 年的自由現金流相似。
Below the free cash flow line in 2025, we paid about $170 million related to contractual milestones for Vtama, Emgality and the biosimilar programs with Shanghai Henlius and made another $66 million in upfront payments, primarily related to acquiring the licensing rights for Tofidence and to a lesser extent, the purchase of the Oss bio manufacturing site. In 2026, we expect that commercial milestone payments will be similar to 2025 at approximately $170 million.
在 2025 年自由現金流線以下,我們支付了約 1.7 億美元,用於支付 Vtama、Emgality 和與上海復宏漢霖合作的生物類似藥項目的合約里程碑款項,並支付了另外 6600 萬美元的預付款,主要用於收購 Tofidence 的許可權,以及較小程度上用於收購 Oss 生物製造基地。我們預計 2026 年的商業里程碑付款將與 2025 年類似,約為 1.7 億美元。
Turning now to leverage on slide 12. Net leverage at year-end was approximately 4.3 times. Consistent with our priority to reduce leverage, during the year, we retired approximately $530 million of debt which included the open market repurchase and cancellation of $419 million of Organon's 5.125% notes due in 2031 including $177 million retired in the fourth quarter, the prepayment of a portion of the long-term debt assumed as part of the Dermavant acquisition and normal quarterly term loan payments.
現在轉向利用第 12 張投影片。年末淨槓桿率約為 4.3 倍。為優先降低槓桿率,我們在這一年中償還了約 5.3 億美元的債務,其中包括在公開市場上回購和註銷 Organon 將於 2031 年到期的 4.19 億美元 5.125% 票據(其中 1.77 億美元在第四季度償還貸款),提前償還作為 Dermavant 收購的部分長期債務貸款。
Given our outlook for approximately $1.9 billion in adjusted EBITDA in 2026, together with approximately $390 million of net proceeds from the Jada divestiture, we expect to be able to achieve net leverage below 4 times by the end of the year. Now turning to the 2026 full year revenue bridge on slide 13.
鑑於我們預計 2026 年調整後 EBITDA 約為 19 億美元,加上從 Jada 出售中獲得的約 3.9 億美元淨收益,我們預計到今年年底能夠實現淨槓桿率低於 4 倍。現在就來看看第 13 頁投影片中的 2026 年全年收入過渡期。
For full year 2026, we expect revenue of about $6.2 billion. We expect LOE to be about $40 million related to a collection of smaller LOEs, for example, CLARINEX in Japan, as well as the potential for a generic of Dulera in the US. We expect VBP impact to be about $30 million and related to the inclusion of Fosamax in round 11. We expect headwinds from price to be about $75 million or about 1.2%, which is lower than what the portfolio has experienced in prior years and it's driven by several factors. First, lapping of the approximate $30 million in onetime gross to net adjustments in the fourth quarter of 2025.
我們預計 2026 年全年營收約 62 億美元。我們預計 LOE 約為 4000 萬美元,涉及一系列較小的 LOE,例如日本的 CLARINEX,以及在美國推出 Dulera 仿製藥的可能性。我們預計 VBP 的影響約為 3000 萬美元,這與在第 11 輪融資中加入福善美有關。我們預計價格帶來的不利影響約為 7,500 萬美元,即 1.2% 左右,低於該投資組合往年所經歷的不利影響,這是由多種因素造成的。首先,在 2025 年第四季一次性毛利淨額調整中扣除約 3,000 萬美元。
Second, we expect stability in US gross to net in the US in 2026. And three, less pricing erosion internationally, particularly in the EU as we lap the LOE of Atozet. And in Japan, as the majority of our portfolio there has already reached pricing parity with generics. We expect volume growth of about $150 million or about 2.4% will be driven by continued contribution from Vtama and Emgality and growth in biosimilars and Nexplanon ex US. And finally, we're estimating that a modest FX tailwind offsets the loss of Jada revenue.
其次,我們預期 2026 年美國毛利淨利將保持穩定。第三,國際價格侵蝕較小,尤其是在歐盟,因為我們即將達到 Atozet 的 LOE。在日本,我們的大部分產品組合已經與仿製藥的價格持平。我們預計銷量將成長約 1.5 億美元,增幅約 2.4%,這主要得益於 Vtama 和 Emgality 的持續貢獻,以及生物相似藥和美國以外地區 Nexplanon 的成長。最後,我們預期適度的匯率利好可以抵銷 Jada 收入的損失。
Turning to slide 14. We expect adjusted gross margin in 2026 to be about 75 to 100 basis points lower than prior year. And while price will be a headwind as it has been in prior years, the main driver of the adjusted gross margin decline in 2026 is higher cost of goods sold related to the release of accumulated foreign exchange translation on inventory that has subsequently matched to revenue when the inventory is sold.
翻到第14張投影片。我們預計 2026 年調整後的毛利率將比上年下降約 75 至 100 個基點。儘管價格將像往年一樣成為一個不利因素,但2026年調整後毛利率下降的主要驅動因素是銷售成本上升,這與庫存中累積的外匯折算釋放有關,而這些庫存隨後在售出時與收入相匹配。
For OpEx, our range for SG&A as a percentage of sales remains in the mid-20% area, and we expect the range for R&D spend to be in the mid-single-digit area. For below-the-line items, our estimate for full year 2026 interest expense is about $500 million, in line with 2025. In 2026, we expect to refinance certain 2028 maturities, which will offset the benefits of recent voluntary debt payments and lower variable interest rates. We expect depreciation of about $140 million for full year 2026 and expect approximately 265 million for our fully diluted share count. For 2026, we estimate our non-GAAP tax rate to be in the range of 27.5% to 29.5%.
對於營運支出,銷售、一般及行政費用佔銷售額的百分比預計在 20% 左右,研發支出預計在個位數百分比左右。對於線下項目,我們估計 2026 年全年利息支出約為 5 億美元,與 2025 年的情況一致。2026 年,我們預計將對某些 2028 年到期的債務進行再融資,這將抵消近期自願償還債務和較低的浮動利率的好處。我們預計 2026 年全年折舊約為 1.4 億美元,預計完全稀釋後的股份數量約為 2.65 億股。我們預計 2026 年的非 GAAP 稅率將在 27.5% 至 29.5% 之間。
The uptick from 2025 is largely due to the full year impact of the implementation of OECD's Pillar 2, 15% global minimum tax, the absence of a tax amortization benefit and an increase in our nondeductible interest expense, offset by use of additional foreign tax credits. Pro forma for any divestitures, we expect cash taxes to be similar to 2025. A
2025 年的成長主要是由於經合組織第二支柱 15% 全球最低稅的實施帶來的全年影響、稅收攤銷優惠的缺失以及不可抵扣利息支出的增加,但這些影響被額外的外國稅收抵免所抵消。假設發生任何資產剝離,我們預計 2025 年的現金稅將與 2025 年類似。一個
s we think about the phasing of the quarters in 2026, we expect revenue growth to build throughout the year, but OpEx is more evenly spread through the quarters. So that means Q1 margin is likely to have the lowest margin of the year, and Q1 could wind up looking a lot like the quarter that we just reported in Q4 of 2025.
當我們考慮 2026 年各季度的安排時,我們預計全年收入成長將逐步增強,但營運支出將在各季度中更均勻地分佈。所以這意味著第一季的利潤率很可能是全年最低的,而且第一季的業績最終可能會與我們剛剛報告的 2025 年第四季非常相似。
In 2026, our primary objective is to maintain performance that aligns with last year. At the same time, we are committed to continuing to manage operating expenses and capital deployment in a disciplined fashion to achieve progress on our deleveraging efforts.
2026年,我們的主要目標是保持與去年相符的業績。同時,我們致力於繼續以嚴謹的方式管理營運費用和資本部署,以在去槓桿化工作中取得進展。
Carrie Cox - Independent Chairman of the Board
Carrie Cox - Independent Chairman of the Board
This is Carrie. Before we go to Q&A, I'd just like to say that we won't be able to answer any questions today regarding the topic referred to in our press release under other matters that was brought to the attention of the Audit Committee yesterday. With that, operator, we are ready to begin Q&A.
這是凱莉。在進入問答環節之前,我想先說明一下,對於昨天提交給審計委員會的其他事項中提到的新聞稿中所提及的主題,我們今天無法回答任何問題。操作員,那麼,我們準備開始問答環節。
Operator
Operator
(Operator Instructions) Umer Raffat, Evercore ISI.
(操作說明)Umer Raffat,Evercore ISI。
Umer Raffat - Equity Analyst
Umer Raffat - Equity Analyst
And Carrie I want to be respectful for what you just said, but not relating to that specific issue on what exactly the specifics are of the purchasing. My question is more higher level. Remember last quarter, I asked you how can one -- anyone know that the channel behavior issues were limited to Nexplanon? And why was the Audit Committee investigation so limited in its scope only to Nexplanon? And I remember at the time, you said it did span beyond look through other product areas and found nothing else.
Carrie,我想尊重你剛才所說的話,但我不想討論購買的具體細節問題。我的問題比較高層次。還記得上個季度我問過你們,如何才能知道通道行為問題僅限於 Nexplanon 嗎?為什麼審計委員會的調查範圍僅限於Nexplanon?我記得當時你說過,它確實超出了其他產品領域,你查看了其他產品領域,但沒有發現其他問題。
Today, we're learning there was another issue. And this time, it's biosimilars purchasing and that too because it was brought up, meaning five other things could be brought up. How can we know that a comprehensive review has been taken? It almost looks like there's an unwillingness by the Board and the leadership to actually solve this for once and do it the right way so we can move on and look at fundamentals and pay down all the $9 billion in debt.
今天,我們得知還有另一個問題。而這一次,是生物相似藥的採購,而且也是因為有人提到了這件事,這意味著還可以提出其他五件事。我們如何才能確定已經進行了全面的審查?看起來董事會和領導層似乎不願意真正解決這個問題,不願意用正確的方式解決,這樣我們才能繼續前進,著眼於基本面,償還全部 90 億美元的債務。
Carrie Cox - Independent Chairman of the Board
Carrie Cox - Independent Chairman of the Board
Thanks, Umer. I'm sorry. We can't provide any additional color at this point.
謝謝你,烏默。對不起。目前我們無法提供任何其他顏色資訊。
Operator
Operator
Mike Nedelcovych, TD Cowen.
邁克·內德爾科維奇,TD Cowen。
Michael Nedelcovych - Equity Analyst
Michael Nedelcovych - Equity Analyst
I have two. My first is on the biosimilar portfolio. Back in October, as you know, FDA released draft guidance limiting the requirement for comparative efficacy studies for biosimilars. So I'm curious what you consider to be the status of this policy in the US. What's your interpretation of that guidance? And what impact should we expect it to have on Organon's business, for example, does it open the biosimilar floodgates and hugely boost margins? Or is it more of an incremental change?
我有兩個。我的第一個目標是生物相似藥產品組合。如您所知,早在去年十月,FDA 就發布了指導草案,限制了對生物相似藥進行療效比較研究的要求。所以我很想知道您認為這項政策在美國的現況如何。你如何理解該指導意見?那麼,我們應該預期這會對 Organon 的業務產生什麼影響呢?例如,它是否會打開生物相似藥的閘門,大幅提高利潤率?或者說,這更像是一種漸進式的改變?
And then my second question is on your 2026 guidance. Can you provide any more detail on the Nexplanon contribution that's contemplated in your 2026 sales guidance and will launch of the longer-acting Nexplanon implant be accretive to total Nexplanon sales this year?
我的第二個問題是關於你們2026年的指導。您能否提供更多關於您在 2026 年銷售預期中對 Nexplanon 的貢獻的細節?長效 Nexplanon 植體的推出是否會增加今年 Nexplanon 的總銷售額?
Joseph Morrissey - Interim Chief Executive Officer, Executive Vice President, Head - Manufacturing and Supply
Joseph Morrissey - Interim Chief Executive Officer, Executive Vice President, Head - Manufacturing and Supply
Mike, I think the first -- the first question on the biosimilars. We feel it would be more incremental. So we think our strategy with biosimilars is the right one of picking the right partners that are positioning their biosimilars in the right order of the ability to launch and building out those partnerships. We're excited about our opportunities in the US, continuing to grow Hadlima as well as with our launch of the denosumab biosimilars and expanding that in other markets around the world and continue to grow in that way. So we see that more incremental.
麥克,我認為第一個問題——關於生物相似藥的第一個問題。我們認為這會是一個循序漸進的過程。因此,我們認為我們在生物相似藥方面的策略是正確的,即選擇合適的合作夥伴,按照正確的順序推出他們的生物相似藥,並建立這些合作關係。我們對在美國的發展機會感到興奮,我們將繼續發展 Hadlima,並推出地諾單抗生物類似藥,將其推廣到世界其他市場,並繼續以這種方式發展壯大。所以我們看到的是漸進式的。
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
And on the second part of the question for 2026 guidance at Nexplanon, we believe Nexplanon will be roughly flat year on year. We've got pushes and pulls on the Nexplanon business. Ex US, the business will continue to grow nicely. We talked about improved access to Nexplanon in Latin American markets. In the United States, we'll have consistent with the launch of the five-year label, we will have a bit of a dip due to no reinsertion.
關於 Nexplanon 2026 年業績指引的第二部分問題,我們認為 Nexplanon 的業績將與前一年大致持平。Nexplanon業務目前面臨一些阻力和推動因素。除美國以外,該業務將繼續保持良好的成長動能。我們討論如何改善拉丁美洲市場對 Nexplanon 的取得途徑。在美國,隨著五年期標籤的推出,由於沒有重新插入,銷量將略有下降。
Roughly -- and we've said 10% to 15%, let's call it, 13% of insertions annually are actually reinsertions. So now with the move to three to five years, that will create a bit of an inflection point in volume there. And some of the channel issues that we experienced in the second half of the year will annualize. So net-net, the contribution of Nexplanon to our 2026 guidance is to summarize roughly the level with 2025. But we remain optimistic that the attractiveness of the five-year label, especially for high BMI patients, and now with the duration making the product more attractive versus other long-acting reversible contraceptives, bode very well for the long-term growth of the product, both inside and outside the United States.
粗略估計——我們之前說過 10% 到 15%,我們姑且稱之為 13% 吧,每年植入的植入物中實際上有 13% 是重新植入的。所以現在隨著期限延長至三到五年,這將在交易量上造成一個轉捩點。我們在下半年遇到的一些通路問題將會持續到全年。綜上所述,Nexplanon 對我們 2026 年業績指引的貢獻是大致與 2025 年的水準持平。但我們仍然樂觀地認為,五年有效期的標籤對高 BMI 患者尤其具有吸引力,而且現在有效期的延長使該產品相對於其他長效可逆避孕藥更具吸引力,這預示著該產品在美國境內外都將有非常好的長期增長。
Operator
Operator
Jason Gerberry, Bank of America.
傑森‧格伯里,美國銀行。
Bhavin Patel - Analyst
Bhavin Patel - Analyst
This is Bhavin Patel on for Jason. Two questions from us. So the first is you're guiding to a flat 2026 adjusted EBITDA of $1.9 billion, and we have $275 million in annualized cost savings from the reset flowing into the P&L. So I guess if we strip out those savings, the underlying EBITDA performance appears to be declining. Maybe if you can help us bridge where that $275 million benefit is being absorbed. Is it purely the 75 to 100 bps of gross margin deterioration? Or are there a massive onetime reinvestments into Vtama and Nexplanon REMS program?
以下是 Bhavin Patel 為 Jason 報道。我們有兩個問題。首先,預計 2026 年調整後 EBITDA 將維持在 19 億美元,並且透過調整,每年可節省 2.75 億美元的成本,這些成本將計入損益表。所以,如果剔除這些節省,基本 EBITDA 績效似乎正在下降。或許您可以幫我們解決這2.75億美元收益的分配問題。只是毛利率下降了 75 到 100 個基點嗎?或者,Vtama 和 Nexplanon REMS 專案是否會進行大規模的一次性再投資?
And then my second question is to double-click on this REMS program that launches in a couple of weeks with a six-month grace period ending in August. So does your 2026 Nexplanon outlook assume any volume bottlenecks or certification friction in the second half of the year once that mandate is fully enforced? And maybe does the REMS mandate distributor registration potentially provide you with like a cleaner data to monitor the wholesaler days of coverage?
我的第二個問題是,雙擊這個 REMS 計劃,它將在幾週後啟動,並有六個月的寬限期,到八月結束。那麼,您對 2026 年 Nexplanon 的展望是否考慮到了該強制性措施全面實施後,下半年可能出現的任何銷售瓶頸或認證摩擦?REMS 強制經銷商註冊或許能為您提供更清晰的數據,以便監控批發商的承保天數?
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
So I'll take the first part of the question, Juan Camilo can take the REMS question. So on the operating expense savings, the $275 million we referred to when we spoke earlier in the year was all related to gross takeouts that we were going after in sort of the base administrative and structural elements of our cost structure. That was the gross number we were going after. That enabled us to take a portion of that and reinvest it, for example, in increased enhanced promotional activity for Vtama. So when you asked the question, you essentially answered it by saying that some of that $275 million would be redirected to revenue growth opportunities.
所以我來回答問題的第一部分,胡安·卡米洛可以回答 REMS 問題。因此,關於營運費用節省,我們今年稍早提到的 2.75 億美元全部與我們在成本結構的基本行政和結構要素方面追求的總支出有關。這就是我們想要達到的毛利目標。這使我們能夠將其中的一部分進行再投資,例如,用於增加對 Vtama 的推廣力度。所以,當你提出這個問題時,你實際上回答說,這 2.75 億美元中的一部分將重新分配到收入成長機會。
I'll take a step back and say that the management team here continues to go after OpEx very aggressively. We've built another round of OpEx savings into our 2026 guidance, not quite as large as the 2025 effort, but certainly in the same ballpark. And it's just essential that we continue to rightsize the operating expense footprint of the company in light of what's happening in terms of our gross margins being compressed.
我退一步說,這裡的管理團隊一直非常積極地追求營運支出。我們在 2026 年的業績預期中又增加了一輪營運支出節省,雖然規模不如 2025 年,但肯定在同一水平線上。鑑於毛利率不斷下降,我們必須繼續調整公司的營運費用規模,這一點至關重要。
Now I'll turn the question over to Juan Camilo for REMS.
現在我將這個問題交給 REMS 的 Juan Camilo 來回答。
Juan Ferreira - Executive Vice President, Head of Research and Development and Chief Medical Officer
Juan Ferreira - Executive Vice President, Head of Research and Development and Chief Medical Officer
Yes. Thank you, Matt, and thanks, Jason. Yes. We are pretty confident that with this window that we have and the efforts that we have already planned, we will be able to recertify the prescribers that constantly use or loyalty use of Nexplanon. This physicians that have been already certified before will have a very small requirement that will take them around 15 to 20 minutes to be certified.
是的。謝謝你,馬特,也謝謝你,傑森。是的。我們相當有信心,憑藉我們目前掌握的時間窗口和我們已經計劃好的努力,我們將能夠重新認證那些經常使用或忠誠使用 Nexplanon 的處方醫生。對於之前已經獲得認證的醫生來說,認證的要求非常低,大約需要 15 到 20 分鐘即可完成。
So we are pretty confident that we'll be able to maintain the volume based on the retraining that I believe was your question. The other factors are the ones that Matt and Joe already covered.
因此,我們相當有信心能夠根據重新培訓的情況維持目前的產量,我相信這就是你提出的問題。其他因素馬特和喬已經討論過了。
Operator
Operator
Chris Schott, JPMorgan.
克里斯‧肖特,摩根大通。
Ethan Brown - Analyst
Ethan Brown - Analyst
This is Ethan on for Chris. Maybe just building on the margin commentary, just maybe taking a step back, what are your latest thoughts on what operating costs and margins can look like over time from here? And then on Nexplanon, very helpful commentary on the headwinds going to the five-year indication. Just maybe how long should we think about that headwind -- about the duration of that headwind? And are there any potential offsets via price there?
這裡是伊桑替克里斯發言。或許可以基於利潤率的評論,退一步思考,您目前對未來的營運成本和利潤率有何看法?然後是關於 Nexplanon 的,對五年指標所面臨的不利因素進行了非常有幫助的評論。或許我們應該思考一下這種逆風會持續多久──也就是這種逆風會持續多久?那麼價格方面是否存在任何潛在的抵銷因素呢?
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
So the first part of the question relates to OpEx. And I think the challenge for the company as we've seen gross margins compress since the spin is to continue to streamline, make the business more efficient, get economies of scale where we can. And I just make the broad comment that it's incumbent upon us to continue to do that. And -- but at the same time, make sure that we are not sacrificing OpEx where it can draw a clear line to revenue growth and value creation in the top line. So I don't have a numerical answer to the question.
所以問題的第一部分與營運支出有關。我認為,隨著分拆後毛利率的下降,公司面臨的挑戰是繼續精簡業務,提高效率,盡可能實現規模經濟。我只想籠統地說,我們有責任繼續這樣做。但同時,也要確保我們不會為了提高收入成長和創造營收價值而犧牲營運支出。所以,我無法給出這個問題的數值答案。
What I have is the philosophy here that we are deploying -- have been deploying as we try and manage a bottom line that optimizes what our opportunity is. On the five-year and the reinsertion, I think this year will be the most pronounced for it, 2026. We might be talking about reinsertion risk in 2027. It should be at a fairly significantly lower level than what we're talking about this year.
我在這裡所秉持的理念是——我們正在推行——並且一直在推行——我們努力管理底線,以最大限度地利用我們的機會。關於五年期和重新加入,我認為今年(2026 年)將是最明顯的一年。我們或許會在 2027 年討論再次植入的風險。應該會比我們今年討論的水平低得多。
Operator
Operator
David Amsellem, Piper Sandler.
大衛·阿姆塞勒姆,派珀·桑德勒。
Alex von Riesemann - Analyst
Alex von Riesemann - Analyst
This is Alex on for David. The first one is, can you talk to the pressure on established brands and how we should think about key established brand segments, not only in 2026 but also beyond? And how you're thinking about potential trouble spots such as respiratory? And then on Vtama, how are you thinking about competitive dynamics for the product given that growth has been slower than topical roflumilast? So with that in mind, how are you thinking about your support of the product?
這裡是Alex替David報道。第一個問題是,您能否談談成熟品牌面臨的壓力,以及我們應該如何看待關鍵的成熟品牌區隔市場,不僅是 2026 年,還有更遠的未來?您是如何考慮呼吸系統等潛在問題領域的?那麼,關於 Vtama,鑑於其成長速度低於外用羅氟司特,您如何看待該產品的競爭動態?考慮到這些因素,您打算如何支持這款產品?
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
So the first part of that question -- go ahead, Joe.
那麼,問題的第一部分——請講,喬。
Joseph Morrissey - Interim Chief Executive Officer, Executive Vice President, Head - Manufacturing and Supply
Joseph Morrissey - Interim Chief Executive Officer, Executive Vice President, Head - Manufacturing and Supply
Yes. Thanks, Matt. So I think, Alex, the first thing with the established brands, I think Matt said it in his commentary, right? We do think established brands are going to have some years where you have somewhat of a reset like we did with the respiratory in 2025 and then remaining backward flat. I think when we look at it, a lot of the respiratory risk, it may -- it will pull into this year but it's largely we're getting past that as well as some of the declines we had over the year and the prior year in Japan.
是的。謝謝你,馬特。所以我覺得,Alex,對於成熟的品牌來說,首先,我想Matt在他的評論中也說過,對吧?我們認為,成熟品牌將會經歷一些調整期,就像我們在 2025 年對呼吸系統所做的那樣,然後保持平穩發展。我認為,從這個角度來看,許多呼吸系統疾病的風險可能會——它會延續到今年,但總的來說,我們正在克服這些風險,同時也克服了過去一年以及前一年日本的一些下降趨勢。
And so when we look at them, the growth with products like Emgality plus Vtama and so forth, that's where we see stabilization in established brands, but it's still going to be somewhat chunky, I would say, in the future, where we'll have some challenges and then opportunities to offset that with growth. Matt, do you want to take Vtama?
因此,當我們審視這些產品時,像 Emgality 和 Vtama 等產品的成長,我們看到成熟品牌趨於穩定,但我認為未來仍會有些波動,我們會面臨一些挑戰,但也有機會透過成長來抵銷這些挑戰。馬特,你想參加Vtama嗎?
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
Yes. So from a Vtama perspective, as it competes against steroidal nonsteroidal options, we see that 2026, the product is likely to grow in line with the other nonsteroidal topical. So in the 20%, 25% range year on year for Vtama. The only other thing I would add to Joe's comment on established brands is that we continue to add products there that capitalize on the global infrastructure that we have. So we -- the company made an announcement tail-end of last year that we will be marketing Nilemdo in the EU.
是的。因此,從 Vtama 的角度來看,由於它與類固醇類和非類固醇類藥物競爭,我們認為到 2026 年,該產品可能會與其他非類固醇類外用藥物一樣增長。因此,Vtama 的年增長率在 20% 到 25% 之間。關於喬對成熟品牌的評論,我唯一要補充的是,我們將繼續增加能夠充分利用我們擁有的全球基礎設施的產品。因此,我們公司在去年年底宣布,我們將在歐盟銷售Nilemdo。
Not a big product, but it can slide right in similar to Emgality, very little in the way of incremental operating expense necessary and once again, capitalizes on what's a unique asset and feature for Organon's business, which is this global infrastructure that enables us to sell either directly or directly into 140 countries around the globe.
雖然產品規模不大,但它可以像 Emgality 一樣輕鬆融入現有體系,幾乎不需要增加營運費用,並且再次利用了 Organon 的獨特資產和特點,即我們能夠直接或間接向全球 140 個國家/地區銷售的全球基礎設施。
Operator
Operator
Terence Flynn, Morgan Stanley.
Terence Flynn,摩根士丹利。
Terence Flynn - Analyst
Terence Flynn - Analyst
Two for me. I was just wondering if you can give us any update on the search for a permanent CEO? And then the second one relates to the denosumab biosimilar that I know you guys launched end of December. I think Amgen has talked about being able to, on the Prolia side, at least, hold on some more share given they have Evenity as another option. So I guess as you think about your go-to-market strategy, on the denosumab biosimilar specifically for the osteoporosis setting.
我兩個。我想問一下,能否告知我們有關尋找正式CEO的最新進展?第二個問題與你們在 12 月底推出的地諾單抗生物相似藥有關。我認為安進公司已經表示,至少在Prolia方面,他們能夠保住更多的市場份額,因為他們還有Evenity作為另一個選擇。所以我想,當你考慮你的上市策略時,特別是針對骨質疏鬆症的地諾單抗生物相似藥時。
Anything you're doing differently to try to capture more share there?
為了爭取更多市場份額,你們有沒有採取什麼不同的措施?
Carrie Cox - Independent Chairman of the Board
Carrie Cox - Independent Chairman of the Board
So I can take the one on the CEO search. You might recall there was a special committee of the Board formed last year. We've had a very robust process underway, but there's no public update to share right now.
所以我可以接手CEO招募那件工作。您可能還記得,董事會去年成立了一個特別委員會。我們已經開展了一項非常完善的流程,但目前還沒有任何公開的進展可以分享。
Matthew Walsh - Chief Financial Officer, Executive Vice President
Matthew Walsh - Chief Financial Officer, Executive Vice President
And as far as the denosumab question, I think let's just talk about what we should be modeling and how investors should be thinking about Organon's opportunity for that product. And like a lot of the biosimilar partnered opportunities that we have will be competing against highly competitive markets, both from a volume and price perspective when we think about what the peak revenues might be for that denosumab product over both reference products, it's on the order of $100 million in total, let's say, over about a five-year timeframe.
至於地諾單抗的問題,我認為我們應該討論一下應該建立什麼樣的模型,以及投資者應該如何看待 Organon 在該產品方面的機會。就像我們擁有的許多生物相似藥合作機會一樣,我們將與競爭非常激烈的市場競爭,無論從銷售量或價格角度來看都是如此。當我們考慮地諾單抗產品相對於兩種參考產品的最高收入時,我們估計在五年左右的時間範圍內,總收入約為 1 億美元。
Operator
Operator
This concludes the question-and-answer session, and we'll 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。