Organon & Co (OGN) 2024 Q4 法說會逐字稿

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  • Unidentified participant

    Unidentified participant

  • Thank you for standing by mainly [MRIdian] and I will be your conference operator today. At this time, I would like to welcome everyone to the Organon Fourth Quarter and Full Year 2024 for earnings call. (Operator instructions)

    非常感謝大家的支持[MRIdian],今天我將擔任您的會議主持人。現在,我歡迎大家參加 Organon 2024 年第四季和全年財報電話會議。(操作員指令)

  • I would now like to turn the call over to Juan.

    現在我想把電話轉給胡安。

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • Good morning, everyone. Thank you for joining Organon Fourth Quarter and Full Year 2024 earnings call. With me today are Kevin Ali, Organon's Chief Executive Officer, Matthew Walsh, our Chief Financial Officer, and Juan Camilo, our homeowner Ferrara Organon's, Head of R&D.

    大家早安。感謝您參加 Organon 2024 年第四季和全年財報電話會議。今天與我一起的有 Organon 的執行長 Kevin Ali、我們的財務長 Matthew Walsh 和我們的房主 Ferrara Organon 的研發主管 Juan Camilo。

  • Today, it will be referencing a presentation that will be visible during this call. For those of you on our webcast presentation will also be available following this call on the Events and Presentations section of our Organon Investor Relations website. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward looking statements.

    今天,它將引用本次通話期間可見的簡報。對於那些關注我們網路直播的人來說,本次電話會議結束後,他們還可以訪問 Organon 投資者關係網站的「活動和演示」部分,查看我們的演示內容。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。

  • 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 10K and subsequent periodic filings.

    由於與公司業務相關的風險和不確定性,實際結果可能與前瞻性陳述中明確或暗示的結果存在重大差異,這些風險和不確定性在公司提交給美國證券交易委員會的文件中進行了討論,包括我們的 10K 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,這些指標應被視為根據 GAAP 編制的財務指標的補充,而不是替代方案。新聞稿和電話會議報告中包含了這些非公認會計準則指標與可比較公認會計準則指標的對帳。

  • I would 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)。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Good morning, everyone, and thank you, John. Welcome to today's call. We will talk about our fourth quarter and full year 2024 results. For the full year 2024 revenue was $6.4 billion, representing a 3% growth rate at constant currency. This is the third consecutive year that Organon have delivered constant currency revenue growth.

    大家早安,謝謝你,約翰。歡迎參加今天的電話會議。我們將討論 2024 年第四季和全年的業績。2024 年全年營收為 64 億美元,以固定匯率計算成長率為 3%。這是 Organon 連續第三年實現貨幣收入持續成長。

  • In fact, all three of our franchises have delivered three years of constant currency revenue growth. Adjusted EBITDA was $1.96 billion, inclusive of $81 million of IPR&D, representing a 30.6% adjusted EBITDA margin at SIPR&D.

    事實上,我們的三個特許經營權均實現了三年的持續貨幣收入成長。調整後的 EBITDA 為 19.6 億美元,其中包括 8,100 萬美元的 IPR&D,佔 SIPR&D 調整後 EBITDA 利潤率為 30.6%。

  • Our adjusted EBITDA margin was 31.8%, about a half a point of margin expansion over last year. On the same basis today, we are also providing guidance for the full year 2025. For this year, we expect revenue to be in the range of $6.125 billion to $6,325 billion, inclusive of an approximate $200 million headwind from foreign currency or constant currency basis is the midpoint of this range would represent flat revenue performance in 2025.

    我們的調整後 EBITDA 利潤率為 31.8%,比去年同期成長了約半個百分點。今天,基於同樣的基礎,我們也將提供 2025 年全年業績指引。我們預計今年的營收將在 61.25 億美元至 63.25 億美元之間,其中包括來自外幣或固定匯率基礎的約 2 億美元逆差,這個範圍的中點將代表 2025 年的營收表現持平。

  • That is reflective of an approximate $200 million headwind from out of that loss of exclusivity in Europe, which we will look to offset with growth in products like the and of NexPlanar. Our adjusted EBITDA range for 2025 is 31% to 32%, consistent with prior commentary that we intend to manage to hold of 31% adjusted EBITDA margin, floor XIPR. and D. This applies even in 2025 as we manage through the yellow, we have our second largest product.

    這反映出因失去歐洲獨家經營權而產生的約 2 億美元的逆風,我們將尋求透過 NexPlanar 等產品的成長來彌補這一損失。我們對 2025 年的調整後 EBITDA 範圍為 31% 至 32%,與先前的評論一致,即我們打算設法保持 31% 的調整後 EBITDA 利潤率,底線 XIPR。和 D.這甚至適用於 2025 年,因為我們透過黃色進行管理,所以我們擁有第二大產品。

  • Let's move now to discuss the growth drivers within the franchises. In 2024, the women's health franchise grew 5%, ex-exchange, led by performance of NexPlanar, which was up 17% ExFx for the full year of 2024. This was NexPlanar best annual performance ever and positions the product to achieve at least $1 billion of revenue in 2025 in 2020 for next one on grew double digit, both in the US and in international markets.

    現在讓我們來討論一下特許經營內的成長動力。2024 年,女性健康特許經營業務成長 5%(不含交易所),其中 NexPlanar 的業績領先,2024 年全年上漲 17%(不含交易所)。這是 NexPlanar 有史以來最好的年度業績,並預計在 2025 年和 2020 年實現至少 10 億美元的收入,並在接下來幾年內在美國和國際市場上實現兩位數的成長。

  • Outside the U.S growth in the Americas region was particularly strong, driven by increased demand, tender expansions as well as strong performance in Brazil. We also had a strong growth in the UK were Nexsan is a market leader in the US. We benefited from next one and market leadership, coupled with our pricing strategy, which includes management of the $340 billion. discount program as well as continued growth in physician demand.

    除美國外,美洲地區的成長尤其強勁,這得益於需求增加、招標擴張以及巴西的強勁表現。我們在英國也取得了強勁成長,Nexsan 在美國佔據市場領先地位。我們受益於下一個舉措和市場領導地位,再加上我們的定價策略,其中包括對 3,400 億美元的管理。折扣計劃以及醫生需求的持續增長。

  • We remain very optimistic about the future X1 on, especially with the potential of a five year indication to sustain long, long term. Next one on growth in 2024, we submitted our five year study package to the FDA, which had strong results, including zero pregnancies and no new safety signals. We also have collected data from the same study on women with a high BMI, where there is a significant unmet need for new, highly effective option with an adequate safety profile.

    我們對 X1 的未來仍然非常樂觀,尤其是考慮到其五年內能夠長期維持的潛力。下一個是關於2024年的成長,我們向 FDA 提交了我們的五年研究方案,結果非常好,包括零懷孕和沒有新的安全訊號。我們也從同一項研究中收集了針對高 BMI 女性的數據,這些女性對於具有足夠安全性的新型高效治療選擇存在巨大的未滿足需求。

  • Late in 2024, we made our submission to the FDA, putting us in a position to be ready for late 2025 launch pending FDA approval. Also in women's health data grew to $61 million in 2024 and celebrated 100,000 units shipped since launch, over 90% of the largest berthing hospitals in the US now stop JV. We expect continued growth of data in 2025 as we drive depth in our existing base and advocate for Jade has continued incorporation into hospital protocols. Rounding out women's health, our Fertility franchise was down 2% ex-exchange in 2024 in the U.S.

    2024 年末,我們向 FDA 提交了申請,準備在 FDA 批准後於 2025 年末推出。此外,在女性健康領域,數據在 2024 年增長到 6,100 萬美元,自推出以來已出貨 10 萬台,美國 90% 以上的大型靠泊醫院現已停止合資。隨著我們進一步深化現有數據基礎並提倡將 Jade 繼續納入醫院協議,我們預計 2025 年數據將繼續成長。在女性健康領域,我們的生育特許經營業務在 2024 年在美國下跌了 2%。

  • We worked through a late 2023 buy-in for Folotyn due to the exit of a spin related in term operating model. This offset growth we saw from new launches in Latin America, Japan and Turkey, and strong performance in the Asia Pacific region. Our facility products in China are performing better than the market, and we are well positioned to capture growth when that market accelerates in 2020.

    由於與旋轉相關的長期營運模式的退出,我們在 2023 年末完成了對 Folotyn 的買入。這抵消了我們在拉丁美洲、日本和土耳其新產品推出時所看到的成長以及亞太地區的強勁表現。我們在中國的設施產品表現優於市場,當 2020 年中國市場加速發展時,我們有能力抓住成長機會。

  • For our biosimilar franchise grew 12% at constant currency, in part because of our ability to capture more than our contractual share of the Brazil tender for onto resolved with rents, licenses and Andreas Arndt at the mature between there, longer than projected lifecycle will likely see a decline in biosimilars in the middle single digit range in 2025, we expect continued strong growth in has Lima following our US launch in July of 2023 and late in 2025.

    我們的生物仿製藥特許經營權按固定匯率計算增長了 12%,部分原因是我們有能力獲得超過我們在巴西招標中的合約份額,這些招標通過租金、許可證和 Andreas Arndt 解決,在兩者之間的成熟期,預計生命週期較長,到 2025 年,生物仿製藥可能會繼續出現中等大小的 2025 月 2025 年生物仿製藥可能會在 202 月繼續增長,美國生物仿製藥後將持續 2025 月 2025 月在 202 年後繼續成為 2025 月。

  • Pending FDA approval, we expect to launch at the nose I-Mab biosimilar in collaboration with Shanghai, unless we also plan to launch it biosimilar for Perjeta in the EU and in Latin America and 2026 with the U.S. following those launches.

    在獲得 FDA 批准後,我們預計將與上海合作推出 I-Mab 生物仿製藥,除非我們還計劃在歐盟和拉丁美洲推出 Perjeta 生物仿製藥,並於 2026 年在美國推出。

  • Lastly, we continue to see further business development opportunities to build out our pipeline for biosimilars. Wrapping up the revenue discussion with established brands established brands grew 2% ex-exchange for the full year of 2024, contributions from Emgality and the Terumo along with recovery and an injectable steroids more than offset the impact from the other. We have out of that and an unfavorable pricing dynamic in Japan.

    最後,我們繼續看到進一步的業務發展機會,以擴大我們的生物相似藥產品線。總結成熟品牌的收入討論,成熟品牌 2024 年全年收入同比增長 2%,Emgality 和 Terumo 以及恢復和注射類固醇的貢獻超過了其他品牌的影響。我們已經擺脫了這一困境,而且日本的定價情況也較為不利。

  • Before turning to R&D pipeline, let's spend a few minutes discussing our strategy and where we're at at this point in time. Even for spin, we knew that we had substantial work to do in order to stand up this new company and build out the capabilities required for success. During this period, we established Organon as a leader in women's health, completed 11 business development transactions achieved double digit revenue. Cadence was NexPlanar and drove growth in our base business. We also began to streamline our operating expenses with the goal of expanding profitability.

    在轉向研發管道之前,讓我們花幾分鐘討論一下我們的策略以及目前的情況。即使是對於分拆,我們也知道,為了建立這家新公司並建立成功所需的能力,我們還有很多工作要做。在此期間,我們確立了 Organon 作為女性健康領域領導者的地位,完成了 11 項業務發展交易,並實現了兩位數的收入。Cadence 是 NexPlanar,推動了我們基礎業務的成長。我們也開始精簡營運費用,以提高獲利能力。

  • You see that both of those actions in our full year 2024 results with non-GAAP operating expenses at IPR&D down 2% for the last two years. We've also tailored our business development approach to focus on transactions like gallons in Derma that the drive earnings accretion and enhance our revenue growth profile for driving a lean culture focused on profitable growth, where we see our kegger on both revenue and adjusted EBITDA accelerating through the end of the decade.

    您可以看到,這兩項舉措都體現在我們 2024 年全年業績中,過去兩年 IPR&D 的非 GAAP 營運費用下降了 2%。我們還調整了我們的業務發展方法,將重點放在 Derma 的加侖交易上,這將推動盈利增長並提高我們的收入增長狀況,從而推動專注於盈利增長的精益文化,我們看到我們的收入和調整後的 EBITDA 都將在本世紀末加速增長。

  • That will be powered by the portfolio we have in hand as well as future business development activities. Let's talk about our specific plans in 2025 and focus on four specific strategic pillars one, continued demonstration of resiliency in our base business. Our base business represents a material driver of value for our company. We've aggressively manage this portfolio since spin driving cash flow for reinvestment and growth to capturing efficiencies.

    這將由我們現有的投資組合以及未來的業務發展活動所推動。讓我們來談談我們 2025 年的具體計劃,並重點關註四個具體的策略支柱:第一,繼續展示我們基礎業務的彈性。我們的基礎業務代表著我們公司價值的重要驅動力。自從旋轉推動現金流進行再投資和成長以獲得效率以來,我們一直積極管理該投資組合。

  • When we look at our operations, we are ready in the process of implementing multiple initiatives that will drive significant operating savings during the calendar year of 2025. Those savings will more than offset the $180 million of expenses of Derma that post synergies. We are reframing the way the company operates to be more nimble, eliminating reporting layers and increasing spans of control, also position the Company for profitable growth, three, consistent deployment of capital. We're committed to our regular dividend as our number one capital allocation priority and for delivering on the promise of our growth products and pipeline. This includes eclipsing $1 billion mark for NexPlanar for the calendar year of 2012.

    當我們審視我們的營運時,我們已準備好實施多項舉措,這些舉措將在 2025 日曆年帶來大幅的營運節約。這些節省的費用將足以抵消 Derma 因協同效應而產生的 1.8 億美元費用。我們正在重新建構公司的營運方式,使其更加靈活,消除報告層級並增加控制範圍,同時也使公司獲利成長,三是持續部署資本。我們致力於將定期股利作為我們的首要資本配置重點,並兌現我們對成長產品和通路的承諾。這包括 NexPlanar 在 2012 年度突破 10 億美元的大關。

  • Finally, we also have a line of sight to deliver more than $300 million of revenue from our recent business development transactions, specific functionality and the Dermabond acquisition. With $150 million of that coming from the TAM, we're off to a strong start with the Tampa taking recent data ending January 31st, the TAM of saw strong NRx growth of 51% over the pre 80 approval 13-week average.

    最後,我們還有望透過最近的業務發展交易、特定功能和 Dermabond 收購實現超過 3 億美元的收入。其中 1.5 億美元來自 TAM,我們開局強勁,根據坦帕截至 1 月 31 日的最新數據,TAM 的 NRx 成長率強勁,比 80 個批准前 13 週平均值高出 51%。

  • For comparison, our direct competitors were up only 5%, determine TRx also outperform competitors by 10 points on that same basis, we remain comfortable with our revenue estimate for the Teva in 2025, especially following the broad favorable and differentiating label we received in December.

    相較之下,我們的直接競爭對手僅成長了 5%,確定 TRx 也比競爭對手高出 10 個百分點,在同樣的基礎上,我們對 2025 年 Teva 的收入預測仍然感到滿意,尤其是在 12 月我們獲得廣泛有利和差異化的標籤之後。

  • In atopic dermatitis, the TAM is the only nonsteroidal topical approved for mild model and severe atopic dermatitis, providing access to all segments of the market in patients as young as two years of age, these have delivered systemic like efficacy has no black box warning, no contraindications. I know duration ore body surface area limitations, allowing for treatment across varying levels of disease severity had been visited from the field. Health care professionals are telling us they have been waiting for this approval, but they have felt an obligation to expand the use of nonsteroidals, especially for children.

    在異位性皮膚炎中,TAM 是唯一獲準用於治療輕度和重度異位性皮膚炎的非類固醇用藥物,可為所有細分市場的患者提供治療,最小可治療兩歲,這些藥物具有類似全身性的療效,沒有黑框警告,也沒有禁忌症。我知道礦石體表面積的限制,允許對不同嚴重程度的疾病進行治療,這一點已經從現場進行了訪問。醫療保健專業人士告訴我們,他們一直在等待這項批准,但他們感到有義務擴大非類固醇藥物的使用,特別是針對兒童。

  • And that there has yet to be a product that could treat the entire family for all feedback has confirmed that there is a significant unmet need in atopic dermatitis. And finally, in 2025, we also will be approaching stage gates in our R&D pipeline. Some of them like OG. six two one nine that have the potential to be game changing programs. With that, I'll turn it over to Juan Camilo, speak more about our R&D priorities.

    而目前還沒有一種產品可以治療全家人的所有回饋,證實了在治療異位性皮膚炎方面存在著巨大的未滿足的需求。最後,到 2025 年,我們的研發流程也將進入關鍵階段。其中一些人喜歡 OG。六二一九有可能成為改變遊戲規則的程式。接下來,我將把主題交給胡安‧卡米洛 (Juan Camilo),進一步談談我們的研發重點。

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • Thank you, Kevin. Our research and development organization plays a pivotal role in shaping Organon's long-term growth and fulfilling our mission. We strive to address long-standing unmet needs and realize our mission of better and healthier every day for everyone. To accomplish this, we work to maximize the potential of our existing assets through lifecycle management, advance novel therapeutics through clinical development process and explore innovative modalities to improve health.

    謝謝你,凱文。我們的研發機構在塑造 Organon 的長期發展和實現我們的使命方面發揮著關鍵作用。我們努力解決長期未滿足的需求,實現讓每個人每天都過得更美好、更健康的使命。為了實現這一目標,我們致力於透過生命週期管理最大限度地發揮現有資產的潛力,透過臨床開發過程推進新療法,並探索改善健康的創新模式。

  • Starting with exciting regulatory milestones in December, we received approval for the Talmer for the treatment of atopic dermatitis in adults and children down to two years of age. Despite an extended review period to a collaborative engagement with the FDA, we achieved approval on our original time line, reflecting our proactive approach. The approved label outlines the compelling benefit risk profile differentiated from the labels of the other available treatment options for atopic dermatitis with Derma that we also acquired DMD five oh six, a preclinical RL hydrocarbon receptor agonist with potential applications in immunological inflammatory diseases and multiple routes of administration, our collaboration with Shanghai Henley.

    從 12 月令人興奮的監管里程碑開始,我們獲得了 Talmer 的批准,用於治療成人和兩歲以下兒童的異位性皮膚炎。儘管與 FDA 合作的審查期延長,但我們還是在原定的時間內獲得了批准,這反映了我們積極主動的做法。該批准的標籤概述了引人注目的益處風險概況,與 Derma 治療異位性皮膚炎的其他可用治療方案的標籤有所區別,我們還與上海亨利合作獲得了 DMD 506,這是一種臨床前 RL 碳氫化合物受體激動劑,在免疫炎症疾病和多種給藥途徑中具有潛在應用。

  • This has advanced to biosimilars HLA 14, a biosimilar candidate for the nine months, probably ex Java for the treatment of osteoporosis and cancer related skeletal events and HLX. 11, a candidate for participation and ask for data for the treatment of breast cancer. Both biosimilar labeling applications have been accepted by FDA with HLX. 14 being potentially available in the U.S. later in 2025, pending FDA review and approval.

    該藥物已發展為生物相似藥 HLA 14,這是九個月來的生物相似藥候選藥物,可能來自爪哇,用於治療骨質疏鬆症和癌症相關的骨骼事件和 HLX。 11、一名候選人參與並索取乳癌治療的數據。HLX 的兩種生物相似藥標籤申請均已被 FDA 接受。 14 可能在 2025 年下半年在美國上市,但需等待 FDA 的審查和批准。

  • As Kevin mentioned, we submitted robust data from our five year NexPlanar study to the FDA. And if approved, we expect to be able to launch this five year indication by the end of this year. Additionally, the study included data and women with body mass index about 30 with the potential to address significant need. Our contraceptive options and its population are long acting recombinant human follicle stimulating hormone SJO. two is under review by the China Water agency.

    正如凱文所說,我們向 FDA 提交了我們五年 NexPlanar 研究的可靠數據。如果獲得批准,我們預計將能在今年底推出這項五年計畫。此外,該研究還包括體重指數約 30 的女性數據,有可能滿足重大需求。我們的避孕選擇及其人群是長效重組人促卵泡激素SJO。二是正在接受中國水利部審查。

  • If approved, it will be the first of its kind in China for control of our stimulation bargain on acquired the exclusive commercialization rights for SJO. two in Mainland China from Zoo country gene pharmaceuticals. On the clinical development side, early in 2023% on made a strategic investment in Clarion Medical, Inc., a privately held company, developing an investigation on medical device for use during minimally invasive laparoscopic hysterectomy. Clarios responsible for clinical development and the clinical trials to support registration are underway.

    如果獲得批准,這將是中國首個控制我們獲得的SJO獨家商業化權利的刺激協議。中國大陸有兩家基因製藥公司。在臨床開發方面,2023 年初,公司對私人控股公司 Clarion Medical, Inc. 進行了策略性投資,進行了一項用於微創腹腔鏡子宮切除術的醫療設備研究。Clarios 負責臨床開發,並且支援註冊的臨床試驗正在進行中。

  • Perhaps the biggest potential opportunity we have is OG six to one nine acquired as part of the for Endo transaction OG. six to one nine as a potential novel therapy for endometriosis and is currently in Phase two and the materials. This is a chronic disease affecting up to one in 10 women of reproductive age age is associated with abdominal pain among many other debilitating symptoms and is a common cause of infertility currently available treatments.

    也許我們最大的潛在機會是作為 Endo 交易的一部分收購 OG 的六比一九。六到十九是一種治療子宮內膜異位症的潛在新療法,目前正處於第二階段。這是一種慢性疾病,影響多達十分之一的育齡婦女,並伴隨腹痛和許多其他使人衰弱的症狀,是目前可用的治療方法不孕的常見原因。

  • Only address Spain have limited efficacy limited duration of use for have significant side effects, including decreases in bone mineral density and menopausal symptoms. Results from the Phase two study are expected in mid 2025 with potential to initiate Phase three studies in 2026. Successful OG six to one nine has the potential to be and new non-hormonal treatment option for endometriosis by the end of the decade.

    僅針對西班牙的治療具有有限的功效並且使用時間有限,有明顯的副作用,包括骨礦物質密度下降和更年期症狀。第二階段研究的結果預計將在 2025 年中期公佈,並有可能在 2026 年啟動第三階段的研究。成功的 OG 六比一九有可能在十年內成為子宮內膜異位症的新的非荷爾蒙治療選擇。

  • We also have a backup program which supports our goal to deliver a product based on this novel mechanism. And finally, OG. eight two seven six eight is being developed for the potential treatment of dysmenorrhea in Japan. We have positive top-line results from the Phase three study and expect to complete the study Ascension and a regulatory submission in Japan later this year. We are excited by the potential of our development assets to address significant medical needs.

    我們還有一個備份程序,它支援我們基於這個新機制交付產品的目標。最後,OG。八二七六八正在日本進行開發,用於治療經痛。我們獲得了第三階段研究的積極頂線結果,並預計將於今年稍後完成 Ascension 研究和在日本的監管提交。我們對我們的開發資產滿足重大醫療需求的潛力感到非常興奮。

  • If successful, this innovation is could contribute substantial revenue over the next five to 10 years. With that, I will pass it to Matt for additional details about our performance.

    如果成功的話,這項創新將在未來五到十年內帶來可觀的收入。說完這些,我會將其轉交給馬特,以獲取有關我們表現的更多詳細資訊。

  • Matthew Walsh - Chief Financial Officer, Executive Vice President

    Matthew Walsh - Chief Financial Officer, Executive Vice President

  • Thank you, Juan Camilo, beginning on Slide 11. Here, we bridge the 3% constant currency full year revenue growth year over year. Starting on the left, LOE. was about $55 million for the year, which reflects the full year impact of the loss of exclusivity of that in Japan and the impact of the LOE. in Europe, which occurred in September, there was an approximate $15 million impact from VBP. It was really contained in the first half of the year and related around eight that began in the third quarter of 2023 and included Remeron and Cozaar Hyzaar.

    謝謝胡安·卡米洛,從第 11 張幻燈片開始。這裡,我們計算了以固定匯率計算的全年營收年增 3%。從左邊開始,LOE。全年約為 5500 萬美元,這反映了日本獨佔權喪失和 LOE 的影響對全年的影響。 9 月發生的歐洲事件,VBP 造成的損失約 1,500 萬美元。它確實在上半年得到了控制,並與 2023 年第三季開始的大約 8 種藥物有關,其中包括 Remeron 和 Cozaar Hyzaar。

  • There was an approximate $115 million impact from price for the full year or about 1.8%. Pricing headwinds came primarily from the September, Ella. We have added that in Spain and France as well as from certain mature products in the US like NuvaRing, do layer endocrine Flexus as well as some expected mandatory pricing revisions in Japan. Volume growth for the year was $415 million, representing almost 7% growth across multiple drivers at Lima and Antalya were the largest contributors to volume.

    全年價格影響約 1.15 億美元,約 1.8%。定價阻力主要來自於九月的埃拉 (Ella)。我們補充說,在西班牙和法國,以及美國的某些成熟產品(如 NuvaRing)中,內分泌 Flexus 也會出現層內分泌,日本也會進行一些預期的強制性定價修訂。全年銷量成長 4.15 億美元,佔近 7%,其中利馬和安塔利亞的多個驅動因素是銷量的最大貢獻者。

  • Growth fell by NexPlanar and the recovery of injectables steroids following a market action in 2023 in supply, other capture the lower margin contract manufacturing arrangements that we have with Merck, which had been declining spin off as expected. Lastly, foreign exchange translation had an approximate $80 million impact in the year or about 130 basis points of headwind to revenue, which reflects the strengthening US dollar versus most foreign currencies during the year.

    由於 NexPlanar 和注射類固醇在 2023 年的市場行動之後供應恢復,增長有所下降,其他因素包括我們與默克公司達成的利潤率較低的合約製造安排,而默克公司的分拆業務一直在按預期下滑。最後,外匯折算在當年產生了約 8,000 萬美元的影響,或對收入造成了約 130 個基點的阻力,這反映了今年美元兌大多數外幣的走強。

  • Now let's turn to page 12, where we show key non-GAAP P&L line items and metrics for the full year. For reference, GAAP financials and reconciliations to the non-GAAP financial measures are included in our press release and slides in the appendix to this presentation for gross profit. We are exiting from car cost of goods sold, purchase accounting, amortization and one-time items, which can be seen in our appendix slides.

    現在我們翻到第 12 頁,我們展示了全年關鍵的非 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幻燈片中包含了 GAAP 財務數據和與非 GAAP 財務指標的對賬,以了解毛利。我們正在退出汽車銷售成本、採購會計、攤銷和一次性項目,這些可以在我們的附錄幻燈片中看到。

  • Adjusted gross margin was 61.6% for the full year 2024 compared with 62.7% in the full year 2023. The year-over-year decrease in adjusted gross margin reflects the impacts of unfavorable price, as I discussed, as well as higher inflation impacts, putting $81 billion of IPR&D expense incurred during the year.

    2024 年全年調整後毛利率為 61.6%,而 2023 年全年為 62.7%。調整後毛利率的同比下降反映了價格不利的影響(正如我所討論的)以及更高的通貨膨脹的影響,導致當年的知識產權與開發費用達到 810 億美元。

  • Non-gaap operating expenses were down 2% year over year, reflective of our cost containment efforts of the $81 billion of IPR&D expense in the year, $70 million of it related to our collaboration with Shanghai, Henley us for further advancement of the denosumab and for two Samad biosimilar candidates than $10 million related to a preclinical milestone for certainly a nonhormonal investigational comp Perceptive candidate for the full year, embedded in adjusted EBITDA figure is at $26 million. Transaction loss in foreign exchange, more than half of that, or $15 million was in the latter part of the fourth quarter.

    非公認會計準則下的營業費用同比下降 2%,反映了我們對今年 810 億美元知識產權與開發費用的成本控制努力,其中 7,000 萬美元與我們與上海亨利醫療的合作有關,以進一步推進地諾單抗和兩種 Samad 生物仿製藥候選藥物,而 1,000 萬美元與非激素研究性藥物 Perceptive 60 萬美元,全年調整後的 60 萬美元。外匯交易損失的一半以上(即 1500 萬美元)發生在第四季後半段。

  • After our last update to earnings guidance and related to significant devaluation and unhedged currencies that half of that impact coming from the ruble. This compares favorably to full year 2023, where we realized $43 million of losses on foreign exchange. These factors culminated in an adjusted EBITDA margin of 30.6% for full year 2024 or 31.8% XIPR. and D., as Kevin mentioned, that's a little more than half a point of margin expansion over full year 2023 adjusted EBITDA margin of 31.2%.

    在我們上次更新獲利預測之後,我們發現,與大幅貶值和未對沖的貨幣相關的影響有一半來自盧布。這與 2023 年全年相比表現良好,當時我們的外匯損失為 4,300 萬美元。這些因素最終導致 2024 年全年調整後 EBITDA 利潤率為 30.6% 或 XIPR 為 31.8%。和 D.,正如凱文所說,這比 2023 年全年調整後的 EBITDA 利潤率 31.2% 的利潤率增長了半個百分點多一點。

  • Once again, XIPR. and D. non-GAAP adjusted net income was $1,065 million for full year 2024, consistent with $1,061 million in full year 2023, which is logical, given that both gross profit and operating expense were essentially flat. Reported net income for full year 2024, it was $864 million or $3.33 per diluted share compared with $1,023 million or $3.99 per diluted share in 2023. Net difference is due to a prior year onetime benefit from the termination of a swift tax arrangements.

    再一次,XIPR。 D. 2024 年全年非 GAAP 調整後淨收入為 10.65 億美元,與 2023 年全年的 10.61 億美元一致,這是合乎邏輯的,因為毛利潤和營業費用基本持平。報告的 2024 年全年淨收入為 8.64 億美元或每股攤薄收益 3.33 美元,而 2023 年為 10.23 億美元或每股攤薄收益 3.99 美元。淨差額是由於上年終止快速稅收安排產生的一次性收益。

  • Turning to Slide 13. We delivered $967 million of free cash flow before one-time costs in 2024, which met our expectation from the start of the year in the top half of the table and where that stands out in free cash flow before one-time items is cash taxes, which were higher in 2024, as we expected, due to the payment of certain non-US taxes as well as settlements in various jurisdictions that triggered higher cash taxes relative to 2023, which happened to be an unused usually low year for cash taxes.

    翻到第 13 張投影片。我們在 2024 年實現了 9.67 億美元的一次性成本前的自由現金流,這符合我們年初在表格上半部分的預期,而在一次性項目前的自由現金流中,現金稅的突出表現是,正如我們預期的那樣,2024 年的現金稅對於更高,這是由於支付了某些非美國稅款以及在各個司法管轄稅區的 2023 年的現金稅通常是更高的現金。

  • Looking ahead to 2025, we would expect cash taxes to be similar to those of 2024. Working down this table, we had expected about $100 million of working capital use in 2024. We ended the year a bit better attributable to active cash cycle working capital management. For the full year, onetime spin-related costs were $160 million, which is better than the $200 billion we were originally forecasting for 2024 and in 2025. We expect these spin-related costs to be essentially zero in the $190 million of other one-time costs.

    展望 2025 年,我們預期現金稅將與 2024 年相似。根據該表,我們預計 2024 年營運資金使用量約為 1 億美元。由於積極的現金循環營運資本管理,我們今年的業績略有改善。全年一次性旋轉相關成本為 1.6 億美元,優於我們最初預測的 2024 年和 2025 年的 2,000 億美元。我們預計這些與旋轉相關的成本在 1.9 億美元的其他一次性成本中基本上為零。

  • About $90 million relates to the ongoing restructuring initiatives that Kevin discussed aimed at leaning out our operating expense. Another $60 million relates to the planned exit from supply arrangements with Merck that we have discussed in past quarters would be ramping up. These are activities that will enable Organon to redefine our appropriate sourcing strategy and moved it fit for purpose supply chains while focusing on delivering efficiencies in terms of gross margin expansion, which we expect to begin realizing starting in 2027.

    其中約 9000 萬美元與 Kevin 討論的正在進行的重組舉措有關,旨在削減我們的營運費用。另外 6 千萬美元與我們在過去幾季討論過的與默克公司退出供應協議的計劃有關,這一金額將會加大。這些活動將使 Organon 重新定義我們適當的採購策略,並使其適應專用供應鏈,同時專注於提高毛利率擴大的效率,我們預計這一目標將從 2027 年開始實現。

  • So while the spin-related TSA costs are going to be effectively zero in 2025, we will continue to see a one-time costs in both the restructuring and manufacturing separation from Merck. That's again, there could be $325 million to $375 million in 2025. Once again, these one-time costs drive value so 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 and is expected to drive meaningful margin expansion.

    因此,雖然與旋轉相關的 TSA 成本在 2025 年將實際上為零,但我們仍將繼續看到默克重組和製造分離中的一次性成本。也就是說,到 2025 年,這一數字可能會達到 3.25 億至 3.75 億美元。再次,這些一次性成本推動了價值,因此投資者將能夠在 2025 年看到以提高的營運費用效率的形式,並在以後的幾年中看到與更具成本效益的製造相關的形式,並有望推動有意義的利潤率擴張。

  • And thinking about capital allocation priority, as Kevin mentioned, is our dividend. And in the past two years, the highest and best use of the remaining cash flow has been opportunistic. Business development 2024, we made upfront and milestone payments totaling about $350 million. In 2025, we pay a little over $200 million in commercial milestones. We've already paid about $130 million between the TAM is a D approval.

    正如凱文所提到的,考慮資本配置優先權就是我們的紅利。而在過去兩年中,剩餘現金流的最高和最佳利用都是機會主義的。業務發展2024,我們支付了總額約 3.5 億美元的預付款和里程碑付款。2025 年,我們將支付略高於 2 億美元的商業里程碑費用。我們已經支付了約 1.3 億美元,TAM 獲得了 D 級批准。

  • And then Gallatin commercial milestone owns an additional $30 billion to $70 billion would be due at milestones for Henley S. and SJO two R. met. The achievement of these milestones means that we're realizing value for business development 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.

    然後,加拉廷商業里程碑擁有額外的 300 億至 700 億美元,這些資金將用於 Henley S. 和 SJO 兩家 R. 的里程碑會面。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價值,並驗證了 2025 年後 Organon 應該能夠實現的低至中等個位數收入成長之路。

  • Moving to Slide 14. We ended the year at 4.2 times net leverage ratio, up from four times at the end of September, primarily due to the German bank transaction. We assumed about $280 million of Derma event debt-like instruments, which are recorded on our balance sheet at fair value. As we digest this acquisition, leverage could float up to the mid four times area at the halfway point this year before coming down closer to four times by year end when we'll be capturing more benefit from the big TAM a launch.

    移至投影片 14。我們的淨槓桿率從 9 月底的 4 倍上升至 4.2 倍,這主要歸因於德國銀行交易。我們假設 Derma 事件債務類工具約為 2.8 億美元,這些工具以公允價值記錄在我們的資產負債表上。隨著我們消化此次收購,槓桿率可能在今年年中上升至四倍左右,然後在年底降至接近四倍,屆時我們將從大型 TAM 的推出中獲得更多收益。

  • That's a strong statement about the business, given that derm event was the biggest deployers of capital that we've done as a company, we're in the middle of a launch year would be Tampa. And we're also working our way to the adage that LOE. Now turning to 2020 for guidance on Slide 15. Here, we highlight the items driving our 2025 revenue guidance range. Our revenue range for full year 2025 is []$6.1.25 billion to [$6.3 25 billion], while we believe revenue could ultimately land anywhere in this range. If we look for a moment at the midpoint of the range, the midpoint is down just under 3% compared to 2024, which is essentially our estimate of the year over year impact of foreign exchange translation.

    這是對我們業務的一個強有力的聲明,鑑於皮膚病學活動是我們公司迄今投入的最大的資本,我們正處於坦帕的發布年中。我們也在努力實現「LOE」這句格言。現在轉向 2020 年以獲取幻燈片 15 上的指導。在這裡,我們重點介紹推動我們 2025 年收入指導範圍的項目。我們預計 2025 年全年收入為 []61.25 億美元至 [63.25 億美元],但我們相信最終收入可能會落在此範圍內。如果我們看一下該範圍的中點,與 2024 年相比,中點下降了不到 3%,這基本上是我們對外匯折算同比影響的估計。

  • Overall, we expect the uptake of the tenor continued solid performance in reality and organic growth and NexPlanar and other products in our portfolio will help to offset the loss of that is that in Europe, even in this LOE. year, there is a credible path to another year of constant currency revenue growth that is reflected at the high end of our full year revenue guidance for LOE., the expected impact of $160 million to $180 million, which is primarily driven by the LOE I'd add is that in the EU and this commerce showing volume associated with LOE., there's also a price down component for add is that for volume that we retain for a total of about $200 million of total revenue headwind related to the LO., we have added that in 2025.

    總體而言,我們預計該期限的採用將在現實和有機成長中繼續保持穩健表現,而 NexPlanar 和我們產品組合中的其他產品將有助於抵消歐洲的損失,即使在這一 LOE 中也是如此。今年,有一條可靠的道路可以實現又一年的固定貨幣收入增長,這反映在我們對 LOE 全年收入預期的高端。 預計影響為 1.6 億至 1.8 億美元,這主要是由 LOE 推動的,我想補充的是,在歐盟,這種商業顯示與 LOE 相關的交易總量。

  • Moving to the right, we expect the impact from DDP. to be approximately $20 million to $40 million. That relates to around 11 for photomasks, which we expect to be implemented late in 2025. Our range on pricing impact for 2025 is $150 million to $180 million or approximately 2.7 percentage point headwind versus prior year, which is in line with our longer-term expectations from price impact across our entire business, but higher than last year. That is driven by price declines associated with the adage that LOE., as well as continuing competitive pressures in the U.S. within mature products such as Tilera Reflexis NuvaRing.

    向右移動,我們預期 DDP 會產生影響。約 2,000 萬至 4,000 萬美元。這與光掩模約 11 個相關,我們預計將在 2025 年底實施。我們對 2025 年定價影響的範圍是 1.5 億美元至 1.8 億美元,或比上年下降約 2.7 個百分點,這符合我們對整個業務價格影響的長期預期,但高於去年。這是由與 LOE 相關的價格下降以及美國在 Tilera Reflexis NuvaRing 等成熟產品方面持續的競爭壓力所驅動的。

  • For the year, we expect volumes in the range of $380 million to $500 million, reflecting growth in the range of six to almost 8% over last year volume growth will be driven pretty equally by our strategic growth pillars. Nexplanar fertility had Lima and new products such as Emgality in Louisiana. And finally, based on current view of FX, we expect about a $200 million impact from FX in 2025 or 300 basis point headwind, as I said earlier. And this is a function of a 75% of our revenue coming from outside the US.

    我們預計今年的銷售額將在 3.8 億至 5 億美元之間,比去年增長 6% 至近 8%,銷售額的成長將基本上受到我們戰略成長支柱的推動。Nexplanar 生育中心擁有 Lima 和路易斯安那州的 Emgality 等新產品。最後,基於目前對外匯的看法,我們預計 2025 年外匯的影響將達到約 2 億美元,或 300 個基點的逆風,正如我之前所說。我們的 75% 收入來自美國以外。

  • As you think about quarterly revenue cadence in 2025, we believe this will be a story of bookends. We expect the first quarter of 2025 will be our lowest revenue quarter. We expect a fourth quarter of 2025 will be the highest week TAM or ramps through the year and the adidas at Ala, we will have its greatest impacts in the first three quarters of the year. By order of magnitude, we could see more than $100 million swing between the first and fourth quarter of 2025.

    當您考慮 2025 年的季度收入節奏時,我們相信這將是一個書擋的故事。我們預計 2025 年第一季將是我們收入最低的季度。我們預計 2025 年第四季將是 TAM 或全年成長最高的一周,而阿迪達斯在 Ala 的業績將在今年前三個季度受到最大影響。從數量級來看,我們可以看到 2025 年第一季和第四季之間的波動超過 1 億美元。

  • Turning to Slide 16, where we show all components of our earnings guidance. For full year 2025, we expect adjusted gross margin to be in the range of 60% to 61%, about a point lower than midpoint compared to 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 and SG&A expense, we ended 2024, 25% of revenue that's a good barometer for 2025.

    轉到投影片 16,我們展示了獲利預測的所有組成部分。對於 2025 年全年,我們預計調整後的毛利率將在 60% 至 61% 之間,比去年的中點低約一個點。這是我們在 2024 年看到的毛利率壓力的延續,尤其是下半年,由於價格和更高的製造和分銷成本以及銷售、一般及行政費用,我們在 2024 年底的收入為 25%,這是 2025 年的一個很好的晴雨表。

  • On R&D, we ended 2020 forward about 7% of revenue, XIPR. and D. for R & D expense in 2025. Upper single digit as percentage of revenue is probably a good place to get your money model for 2025, given where our revenue guidance landing, that would imply essentially flat OpEx dollars year over year, which is consistent with Kevin's commentary that we are continuing to improve our operating cost efficiency. Those pieces culminate in an adjusted EBITDA guidance range of 31% to 32%. This aligns with prior commentary and remarks made today that we intend to hold a floor on adjusted EBITDA margin of 31% XIPR. and D. Just thinking about quarterly phasing of profitability, we were getting the full run rate benefit of the cost savings actions until later in the year.

    在研發方面,截至 2020 年,我們的收入約為 7%,XIPR。以及2025年的研發費用。考慮到我們的收入指導目標,佔收入百分比較高的個位數可能是獲得 2025 年資金模型的一個好地方,這意味著營運支出同比基本持平,這與 Kevin 的評論一致,即我們將繼續提高我們的營運成本效率。這些因素最終決定了調整後的 EBITDA 指導範圍為 31% 至 32%。這與我們今天的先前評論和言論一致,我們打算將調整後的 EBITDA 利潤率的底線保持在 31% XIPR。和 D. 只考慮季度獲利階段,我們就會在今年稍後之前獲得成本節約行動的全部運行率效益。

  • So timing of the invitation of those savings, along with the uptake of the Tampa could drive 200 basis point delta and adjusted EBITDA margins between the first and fourth quarters of the year. For below the line items. Our estimate for full year 2025 interest expense is about $510 million, which includes about $25 million related to the debt-like instruments assumed in the derm of acquisition. Payments on a portion of those instruments are tied to be TAM of sales exclusive of the Dermabond transaction.

    因此,這些節省的邀請時機以及坦帕的採用可能會在今年第一季和第四季之間推動 200 個基點的增量和調整後的 EBITDA 利潤率。對於以下項目。我們預計 2025 年全年利息支出約為 5.1 億美元,其中包括與收購條款中承擔的債務類工具相關的約 2,500 萬美元。部分儀器的付款與 Dermabond 交易以外的銷售額的 TAM 掛鉤。

  • Interest expense is down approximately $30 million in 2025 as a result of the two refinancing events completed in 2024 and lower borrowing rates on our variable rate debt instruments. For 2025, we 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 two. Depreciation is a touch higher than last year at $135 million, driven by the completion of our new ERP system in 2024 to wrap up, 2024 was a solid year three reasons.

    由於 2024 年完成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降低,2025 年的利息支出將減少約 3,000 萬美元。到 2025 年,我們預計非 GAAP 稅率將在 22.5% 至 24.5% 之間。2024年起的上漲主要是受經合組織第二支柱要求的15%全球最低稅率的影響。折舊費比去年略高,為 1.35 億美元,這得益於我們新的 ERP 系統將於 2024 年完工,2024 年將是穩健的一年,原因有三。

  • First, we delivered revenue and EBITDA growth, both as reported and constant currency. Second, excluding IPR. and D., we improved EBITDA margins year over year. And third, we improve the leverage ratio of the base business below four times. Going into the fourth quarter, net gave us the balance sheet capacity to acquire derm event, and we now have immediate US revenue and commercial capability in dermatology with the prospect for solid growth in 2025.

    首先,我們實現了收入和 EBITDA 成長(無論按報告貨幣還是按固定匯率計算)。第二,排除智慧財產權。 D.我們的 EBITDA 利潤率逐年提高。第三,我們將基礎業務的槓桿率提高到四倍以下。進入第四季度,淨資產使我們的資產負債表有能力收購皮膚病學事件,現在我們在美國擁有直接的收入和皮膚病學的商業能力,並有望在 2025 年實現穩健的成長。

  • On the heels of the launch of the Tampa and a topic there mutated. Since we have discussed, we're going into 2025 with financial guidance that reflects the potential for a fourth year of constant currency revenue growth and stable EBITDA margins. Despite a 10 launch expenses and an LOE of our second largest product to temper the impact of this LOE, we've identified at least $200 million of OpEx savings in 2025 that have a very high probability of being achieved.

    在坦帕號下水後不久,一個話題就改變了。正如我們已經討論過的,我們將在 2025 年制定財務指導,該指導反映了第四年實現固定貨幣收入成長和穩定的 EBITDA 利潤率的潛力。儘管有 10 項發布費用和第二大產品的 LOE 來緩和該 LOE 的影響,但我們已經確定 2025 年至少可節省 2 億美元的營運支出,而且實現這一目標的可能性非常高。

  • And if we're successful here were likely record our best operating expense efficiency metrics since the spinoff. These OpEx savings to benefit not only 2025, but annualized to roughly $275 million, which we will realize in 2026 and thereafter. As the quarters roll out in 2025, we expect our sequential P&L performance to improve throughout the year, which should provide a window into the strength of the underlying business beyond the LOE impact, which we expect to see in the near term here in 2025.

    如果我們取得成功,我們很可能會創下自分拆以來最好的營運費用效率指標。這些營運支出節省不僅會在 2025 年受益,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。隨著 2025 年各季度的展開,我們預計我們的連續損益表現將在全年改善,這應該為我們提供一個窗口,讓我們了解 LOE 影響以外的基礎業務實力,我們預計 LOE 影響將在 2025 年的短期內顯現。

  • With that now let's turn the call over to questions and answers.

    現在讓我們將話題轉入問答環節。

  • Operator

    Operator

  • (Operator instructions)

    (操作員指令)

  • First question comes from the line of [Dan seem].

    第一個問題來自[丹似乎]。

  • Unidentified participant

    Unidentified participant

  • I guess the first one I had is just on Matt, I know you talked about some of the one-time items and 25, can you just provide an estimate for where you think free cash flow will likely land to Tom for the year? And then on the biosimilar opportunity for Damascus, I-Mab, Amgen's talked about some, there will be different erosion curves for Prolia versus ex Java, given kind of different indications and the installed base and it sounds like they feel more confident and protecting Prolia. Just as you guys think about, you know, the commercial dynamics there for that franchise. Any any color on how to think about that at the end of this year into 26?

    我想我第一個問題是關於馬特的,我知道你談到了一些一次性項目和 25,你能否估計一下你認為今年湯姆的自由現金流可能會流向哪裡?然後關於大馬士革、I-Mab 的生物仿製藥機會,安進公司談到了一些,考慮到不同的適應症和安裝基礎,Prolia 與 ex Java 的侵蝕曲線會有所不同,聽起來他們對 Prolia 更有信心並會保護它。正如你們所想的,你們知道,該特許經營的商業動態。您對今年底達到 26 強有何看法?

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • So I'll give free cash flow part of the question first. So we were successful in 2020 for getting close to that $1 billion of free cash flow before one-time items. That was a major goal for us at the beginning of 2024. As we look forward to 2025, we're going to see more of a kit kat duration of that. But our starting point on adjusted EBITDA is going to be about $100 million lower. And so that rolls right through. So our expectation is right around $900 million of free cash flow before one-time items. And then as we think about the drivers down, the free cash flow will be somewhat similar to the 2024.

    因此,我首先會給出問題的自由現金流部分。因此,我們在 2020 年成功實現了扣除一次性項目前的接近 10 億美元的自由現金流。這是我們 2024 年初的一個主要目標。展望 2025 年,我們將看到更多的 kit kat 持續時間。但我們調整後的 EBITDA 起點將低約 1 億美元。這樣一切就順利完成了。因此,我們預計一次性專案前的自由現金流約為 9 億美元。然後,當我們考慮驅動因素時,自由現金流將與 2024 年有些相似。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • I can address the question on the denosumab biosimilar launch by now, we're going to be launching probably later on in the case in the Q4 timeframe. So it'll be probably de minimus in terms of what we can expect for 2025 from the dose and our biosimilar. But going forward, look, we've got a lot of comfort in the buy-and-bill process.

    我現在可以回答有關地舒單抗生物仿製藥推出的問題,我們可能會在第四季度晚些時候推出。因此,就我們對 2025 年劑量和生物相似藥的預期而言,這可能微不足道。但展望未來,我們在購買和付款過程中會感到非常方便。

  • And I can tell you right now that we've had years of experience when you start to think about the last six, seven years of rents lets us our Remicade, biosimilar, NexPlanar and so on and so forth. So we feel very comfortable with our with regards to having a product a good by a solid biosimilar for daclizumab in both Prolia and XGEVA and being able to get some penetration of that product in the coming years flex special gain.

    我現在可以告訴你,我們已經有多年的經驗,當你開始考慮過去六、七年的租金時,我們就有 Remicade、生物相似藥、NexPlanar 等等。因此,我們對擁有一款良好的產品感到非常放心,Prolia 和 XGEVA 都是達克珠單抗的可靠生物相似藥,並且能夠在未來幾年獲得該產品的一些滲透,帶來特殊的收益。

  • Operator

    Operator

  • Next question comes from the line of Michael Eagle causes the TV Colvin.

    下一個問題來自電視科爾文 (TV Colvin) 的邁克爾·伊格爾 (Michael Eagle)。

  • Michael Eagle - Analyst

    Michael Eagle - Analyst

  • The first is on NexPlanar on at least as of November 25, it looks like there's still not been a Paragraph four filing for an explanation on. Can you confirm that you have not received one since then? And more broadly, when you say the landscape, what would you say is the probability that generic NexPlanar comes to the US market before 2030?

    第一個是關於 NexPlanar 的,至少截至 11 月 25 日,似乎仍然沒有第四段的解釋。你能確認從那時起你就沒有收到過嗎?更廣泛地說,當您談到前景時,您認為通用 NexPlanar 在 2030 年之前進入美國市場的可能性有多大?

  • My second question relates to your ambition to accelerate top line and EBITDA growth rate beyond 2026. Do you feel you already have the portfolio necessary to do that? Or is that goal predicated on the idea that you would do additional accretive deals in the future?

    我的第二個問題與您在 2026 年後加速營業額和 EBITDA 成長率的野心有關。您是否認為您已擁有實現此目標所需的投資組合?或者這個目標是否基於您將來會進行更多增值交易的想法?

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • I'll start with the last first and then and then go backwards. So so we do feel very comfortable that dumps when we get past the LOE. about is that this year, which is our second-largest product. And we have we feel very good about the fact that we have a line of sight to be able to still we'll deliver some constant currency growth this year, even in spite of the loss of exclusivity of our second largest product.

    我將先從最後一個開始,然後再倒推。因此,當我們越過 LOE 時,我們確實感覺很舒服。大概就是今年,這是我們的第二大產品。我們非常高興,儘管我們失去了第二大產品的獨家經營權,但我們仍有望在今年實現持續的貨幣成長。

  • But going forward in 2020 through 2030, there is every intention and confidence that we could accelerate growth, both on the top line and bottom line leverage growth that is. And of course, we'll continue to do business development. But right now, we feel comfortable with the portfolio that we have in hand with the tab on our website.

    但展望2020年到2030年,我們有充分的意願和信心加速成長,包括營收和利潤的槓桿成長。當然,我們將繼續開展業務發展。但目前,我們對於我們網站上的標籤和手中的投資組合感到滿意。

  • And I'll get to the your first question in the second one that's going on and other our assets that we can continue to accelerate growth, top line and bottom line in the second half of the decade. Without any doubt about, of course, we will continue to do on continued business development. And then in terms of your first question revolves around around ethanol.

    我將在第二個問題中回答你的第一個問題,以及其他我們的資產,以便我們可以在下一個十年繼續加速成長、營收和利潤。當然,毫無疑問,我們將繼續致力於業務持續發展。然後就您的第一個問題而言,是關於乙醇的。

  • No, a Paragraph four right now that we've received and right now, I've been saying for I don't know, for the last two years, I don't see see really any risk to a large degree of and that's spot on three or five-year for that matter, a reduction in terms of a generic or biosimilar between now and the end of the decade after the end of the decade.

    不,我們現在收到了第四段,現在,我一直在說,我不知道,在過去的兩年裡,我沒有看到真正存在任何很大程度上的風險,而且就此而言,三年或五年內,從現在到本世紀末,仿製藥或生物仿製藥的數量有所減少。

  • I mean that will determine what happens but right now when I start to see the fact that our applicator device is got patent protection through 2030, what I would start to see that our five year indication, which we will hopefully launch by the end of this year, we'll have exclusivity through 2029.

    我的意思是,這將決定會發生什麼,但是現在,當我開始看到我們的塗抹器設備在 2030 年之前獲得專利保護這一事實時,我開始看到我們的五年指示,我們希望在今年年底前推出,我們將擁有獨佔權到 2029 年。

  • If I start to look at all the various issues around, et al and in place that has out of product, it is that there is no precedent there, when I start talking about the benchmarks of either Moreno, medicated IUD., no generic so far. So I don't feel we'll see any generics to the challenge that span all through 2030.

    如果我開始研究周圍的各種問題等,以及已經停產的產品,那就是沒有先例,當我開始談論莫雷諾、藥物子宮內避孕器的基準時,到目前為止還沒有通用的。因此,我認為我們不會看到任何能夠應對 2030 年整個挑戰的通用方案。

  • And so as a result of that, when you start to see that we've got $1 billion, our expectation and this year and you put down especially the growth expected to the end of the decade, you see a big product can be and it's our most profitable product.

    因此,當你看到我們今年的預期收入為 10 億美元,並考慮到預計到本世紀末的成長,你會看到一款大產品,而且它是我們最賺錢的產品。

  • Operator

    Operator

  • Your next question comes from the line of Chris Schott with J.P. Morgan.

    您的下一個問題來自摩根大通的 Chris Schott。

  • Chris Schott - Analyst

    Chris Schott - Analyst

  • Thanks for taking our questions. Just two for me, first off on the Tampa. You've had the asset for several months now. Any surprises of the things about the competitive or commercial landscape? And just would be interested in their latest thinking on the competitive positioning of the TAM on atopic derm versus the initial psoriasis indication?

    感謝您回答我們的問題。對我來說只有兩個,首先是坦帕。您已擁有該資產幾個月了。對於競爭或商業格局有什麼意外的嗎?並且只是對他們關於特應性皮膚病的 TAM 與初始牛皮癬指徵的競爭定位的最新想法感興趣?

  • And then second of on margins and the manufacturing separation from Merck, you're doing you talked about beginning to see that in 2020 and seven. But just any color on the magnitude of benefit we might see and how that might flow at over 2027 and looking past that your Thank you.

    其次,關於利潤率以及與默克的製造分離,您談到了在 2020 年和 2027 年開始看到這一點。但我們可能會看到的利益規模以及這種利益在 2027 年可能如何流動以及展望未來,謝謝。

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • Thanks for the questions, Jason. I'll take the first and then them and it over to Matt to take the second question. Look at every week that goes by more and more confident I was already confident on the acquisition of the TAM on that, what we could do with that product globally and the U.S. Of course.

    謝謝你的提問,傑森。我將回答第一個問題,然後交給馬特回答第二個問題。看看過去的每一周,我都越來越有信心,我已經對收購 TAM 充滿信心,我們可以在全球和美國使用該產品做些什麼。

  • But when you look at NRX.s, um, in terms of weeks ending fourth, January 31st, we've got a 51% growth versus the pre-FDA approval 13-week average baseline. So really solid dumb NRx growth, solid growth in terms of new prescribers of the product is the label that we received from the FDA is outstanding.

    但是當您查看 NRX.s 時,嗯,就截至 1 月 31 日的第四週而言,與 FDA 批准之前的 13 週平均基線相比,我們實現了 51% 的成長率。因此,真正穩健的 NRx 成長,產品新處方的穩健成長是我們從 FDA 獲得的傑出標籤。

  • Where the were the only nonsteroidal topical approve a mild, moderate and severe, you're talking about some two years of age and onwards. So when you think about the competitive landscape of there's no, there's no other nonsteroidal other topical, but actually has down to two years of age of the closest is actually, as I read that starts and six and older are you're talking about efficacy that saw system looks like our efficacy in terms of how easy 75 rates up to 59% on and that really beats everything in the market.

    其中唯一核准的非類固醇用藥是輕度、中度和重度,你說的是兩歲及以上的人。因此,當您考慮競爭格局時,沒有其他非甾體類外用藥物,但實際上最接近的實際上是兩歲以下的兒童,正如我所讀到的,六歲以上的兒童正在談論功效,鋸切系統看起來就像我們的功效一樣,就 75 的容易程度而言,其比率高達 59%,這確實擊敗了市場上的所有產品。

  • And of course, you've got no black box warnings, no safety precautions or drug-drug interactions, no or minimal, essentially systemic absorption. So we're talking about really a phenomenal product, all in one solution once a day, I know duration, ore body surface area limitation.

    當然,沒有黑框警告,沒有安全預防措施或藥物交互作用,沒有或只有極少的全身吸收。所以我們談論的真的是一種非凡的產品,每天一次的一體化解決方案,我知道持續時間、礦體表面積的限制。

  • So when I think about at the potential of the TAM of for hub for what we can do with that product, both in the U.S. And we'll be launching in Canada later this year, it is going to be a very big contributor of growth for us for not only 2025, but also going through the end of the decade and beyond.

    因此,當我考慮到我們可以用該產品做什麼時,無論是在美國,還是今年晚些時候我們將在加拿大推出該產品,它都會成為我們不僅在 2025 年,而且在本世紀末及以後的一個非常大的增長貢獻者。

  • It's a fantastic product, i had a lot of demand now to talk about the other question.

    這是一個非常棒的產品,我現在非常想討論其他問題。

  • Matthew Walsh - Chief Financial Officer, Executive Vice President

    Matthew Walsh - Chief Financial Officer, Executive Vice President

  • So on the subject of gross margin improvement, so at the time of the spin, essentially all of our API. and a good deal of our manufacturing services were provided by Merck, the regulated products. So it takes time to me all these things were in the process of doing it now on the margin expansion that we expect to see would be on the order of 250 basis points to 300 basis points starting in 2027 to would it would roll in over a few years starting at that point. But that's a significant, a significant improvement in our supply chain and manufacturing efficiency that we look forward to come to realize it.

    因此,在毛利率提高的問題上,在分拆時,基本上我們的所有 API 都是如此。我們的許多製造服務都是由受管制產品默克公司提供的。所以對我來說,所有這些事情都需要時間,現在我們正在進行利潤率的擴大,我們預計從 2027 年開始利潤率將增加 250 個基點到 300 個基點,並將從那時起持續幾年。但這對我們的供應鏈和製造效率來說是一個重大的改進,我們期待實現它。

  • Operator

    Operator

  • Your next question comes from the line of David Amsellem with Piper Sandler.

    您的下一個問題來自 Piper Sandler 的 David Amsellem。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • Two quick ones for me. One is regarding your dermatology business that you have or are you hoping to accomplish beyond the TAM on center and assets down the road? That's number one. The number two, can you talk about your net leverage targets over the long term? Forex are around that's been stubbornly high and can you talk about the extent to what you want to get it down a turn or potentially more over the long term?

    對我來說有兩個簡單的問題。一個是關於您現有的皮膚病學業務,或者您希望在未來超越中心和資產的 TAM 來實現這一目標?這是第一點。第二,可以談談你們長期的淨槓桿目標嗎?外匯一直居高不下,您能否談一談您希望將其降低到何種程度,或者長期內進一步降低?

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • Good to hear, David, I'm going to just first question on the TAM. And look, we're concentrated in this year and 25, our launch your most important year to really get out of the gates and not only achieve, but hopefully even surpass the numbers that we gave out in terms of what we expected to drive this year.

    很高興聽到你的聲音,大衛,我首先要問的是有關 TAM 的問題。你看,我們集中精力在今年和 25 年,這是我們啟動最重要的一年,真正走出大門,不僅要實現目標,而且希望甚至超越我們今年預期要實現的數字。

  • From that product, I talked a little bit earlier about of, I think the best in class label that we received from the FDA, that was the one single of risks that we were taking, what we did the acquisition is what would be a delay will look like, given the fact of the market is significantly bigger in terms of number of patients versus rises and the opposite Unity is really existed there. And what came through from the FDA is the label is just best investment class label and so all of you know, let's see how we do this year.

    從那個產品開始,我之前稍微談到了,我認為這是我們從 FDA 獲得的同類最佳標籤,這是我們承擔的唯一風險,我們進行的收購將是延遲的,因為事實上市場在患者數量方面明顯更大,而相反的 Unity 確實存在。FDA 給出的標籤是最佳投資類標籤,所以大家知道,讓我們看看今年的表現如何。

  • I'm confident that we'll do very well and will be on the right trajectory going forward to be able to achieve peak revenues that I think will surprise a lot of folks in the market. But nevertheless, we've got a great vertical that we're building here of the team that came over from Derma. That is our fantastic salesforce.

    我相信我們會做得很好,並且會沿著正確的軌道前進,實現峰值收入,我認為這會讓市場上的許多人感到驚訝。但儘管如此,我們已經從 Derma 團隊建立了一個偉大的垂直團隊。這就是我們優秀的銷售團隊。

  • And we've got medical affairs groups and DTC groups that are really outstanding. And so as a result of that, I have every intention we have every intention of being able to continue to build out our portfolio in dermatology. And first and foremost, to do well with the TAM, a globalized the product because we're going to be launched in Canada and thereafter, we'll start to think about other regions like the EU. and others to really kind of penetrate into those into those segments.

    我們擁有非常優秀的醫療事務團隊和 DTC 團隊。因此,我完全有意願繼續擴大我們在皮膚病學領域的產品組合。首先也是最重要的,要做好 TAM,實現產品的全球化,因為我們將在加拿大推出產品,隨後,我們將開始考慮歐盟等其他地區。以及其他人真正滲透到這些領域。

  • But our app after that, we've got a tremendous opportunity across a variety of different therapeutic areas within the dermatology area that we could add to the bag and our group in the U.S. and also that I'll pass it over to Matte.

    但在我們的應用程式之後,我們在皮膚病學領域的各種不同治療領域獲得了巨大的機會,我們可以將這些機會添加到我們的美國團隊中,而且我會把它交給 Matte。

  • Matthew Walsh - Chief Financial Officer, Executive Vice President

    Matthew Walsh - Chief Financial Officer, Executive Vice President

  • So on to our leverage ratio, David, we had said at the start of 2024 that we thought the business would delever. But low four times by the end of the year, pro forma for the germination sanctions, that number would have been about 3.8 times. So we had we were going into the end of the year with the confidence that we could on board a deal like derm event, which is sort of a manifestation of the idea that we'll delever faster through EBITDA growth then through straight debt reduction.

    戴維,關於我們的槓桿率,我們在 2024 年初就說過,我們認為業務將會去槓桿。但是到年底只有四倍,以發芽制裁的形式,這個數字應該是大約 3.8 倍。因此,我們有信心在年底前達成像 derm 活動這樣的交易,這在某種程度上體現了我們將透過 EBITDA 成長而不是直接減債來更快地實現去槓桿的想法。

  • And okay, 2025 is a launch year for the Tampa, but when you think about what the business can do in 2026, we should be clearly below four times by the end of 2026. And then that so we're getting closer by the end of 2026 to the point where we're in that mid three range where we had been saying since the spin is sensible soft target for a business like this with the kind of cash flow that is that it generates.

    好吧,2025 年是坦帕的發布年,但當你考慮到這項業務在 2026 年可以做什麼時,到 2026 年底,我們的收入應該會明顯低於四倍。然後,到 2026 年底,我們將越來越接近中間三個範圍的目標,我們之前一直說,對於像這樣的企業來說,分拆是一個合理的軟目標,因為它能產生現金流。

  • So we are still very much on that line of reasoning and down. I think we've set up the business to get there once we own work our way through 2025 in the near term issues that we're facing, which are really restricted to 2025. When you think about the things that are growing in 2025, the Tampa and Galaxy had leave NexPlanar. All of those things will keep growing in 2026. The issues the headwinds that we're facing are very near term in nature. And so we expect the ability to make significant progress on leverage in just a few quarters' time once we get on the other side in 2025.

    所以我們仍然堅持這項推理。我認為我們已經為實現這一目標做好了準備,一旦我們自己努力解決 2025 年面臨的短期問題,我們就會實現這一目標,而這些問題實際上僅限於 2025 年。當你想到 2025 年的發展時,坦帕和銀河隊已經離開了 NexPlanar。所有這些因素在 2026 年都將繼續增長。我們所面臨的阻力問題本質上都是短期的。因此,我們預計,一旦我們在 2025 年到達彼岸,我們將能夠在短短幾個季度內取得槓桿方面的重大進展。

  • Operator

    Operator

  • Your next question comes from the line of Maggie best at it by.

    您的下一個問題來自 Maggie best at it by。

  • Unidentified participant 2

    Unidentified participant 2

  • I'd like to ask you about and just to analyze the data and kind of handle areas. There is going to hear you the logic side of the day. Yes, two questions from me. I'm comparing on a competent wise basis, the variations, but vein, my estimates and and delivering the biosimilar pricing decline seems to be higher than what our factor. I understand that the products starting to mature phase of the product life cycles.

    我想問您一些問題,只是想分析一下資料和處理區域。今天我們將聽你講述邏輯方面的內容。是的,我有兩個問題。我正在以合理、明智為基礎進行比較,但我的估計和結果顯示,生物相似藥的價格下降似乎高於我們的因素。我了解產品生命週期中產品開始走向成熟階段。

  • And I would I expect the pricing impact being felt Ultra already, so it can throw some color on what the pricing by flaws and what led to this and which had a competent or and what competitive dynamics like does it would be very helpful.

    而且我預計 Ultra 已經感受到了定價影響,因此它可以闡明定價存在哪些缺陷、導致這種情況的原因以及哪些定價具有競爭力或競爭動態,這將非常有幫助。

  • Secondly, could you help us understand the quarterly cadence on the back of multiple moving pieces that you have this year, pricing at Lima Vitoss, BA, does that? So how should we factor the quarterly cadence for the?

    其次,您能否幫助我們了解今年多個變動部件背後的季度節奏,以及 Lima Vitoss、BA 的定價,對嗎?那麼,我們該如何考慮季度節奏呢?

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • Thanks, largely for the question. All of this, the first in regards to pricing with biosimilars, I think the issue really is probably centered around the [340 b]. pricing with red flags, which is our largest biosimilar reservoir, Remicade biosimilar in the US. But as you said, I mean, you know, we're essentially hitting that curve where we talk about more and more pricing pressures as we start to get more and more biosimilars of influx us in the marketplace.

    謝謝,非常感謝你的提問。所有這些,首先是關於生物相似藥的定價,我認為問題實際上可能集中在 [340 b] 上。帶有紅旗的定價,這是我們最大的生物相似藥庫,即美國的 Remicade 生物相似藥。但正如你所說的,我的意思是,你知道,我們基本上正達到那個曲線,隨著越來越多的生物相似藥湧入市場,我們談論的定價壓力也越來越大。

  • We've had six years of significant growth for Red Flexus, which is indicative, I think, of our ability to commercialize biosimilars. And we're really looking forward for our denosumab launch later on in this year. And then thereafter, our projected launch in Europe and in Latin America in 2026 and then follow thereafter by the U.S.

    Red Flexus 已經經歷了六年的顯著增長,我認為這表明了我們商業化生物仿製藥的能力。我們非常期待今年稍後推出的地諾單抗。此後,我們計劃於 2026 年在歐洲和拉丁美洲推出該產品,然後在美國推出。

  • And of course, as I mentioned in my opening comments, we're also doing a lot of due diligence on variety of different things we can do and buyers sellers with regards to accretive accretive, a business development deals that we can do in 2020 to us to offset some of the issues that we're looking at price in regards to run Flexus and Andreas on.

    當然,正如我在開場白中提到的那樣,我們還在對我們可以做的各種不同的事情以及買家賣家進行大量盡職調查,以了解我們可以在 2020 年達成的一項業務發展交易,以抵消我們正在考慮的與運行 Flexus 和 Andreas 相關的一些價格問題。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • So your question is very important because as you correctly point out, we've got trending during the year that has some pretty significant move is let's just review what that is. We've got the LOE of that as that which had which the impact of that are more front loaded in 2025. By the time you get to the fourth quarter will asset we start the ramp up of became a sales.

    所以你的問題非常重要,因為正如你正確指出的那樣,我們發現今年的趨勢有一些相當重大的變動,讓我們回顧一下那是什麼。我們已經得到了它的 LOE,它的影響在 2025 年會更加顯著。到第四季時,我們的資產將開始增加,銷售額也將開始增加。

  • Approximately two thirds of our annual projection there is realized in the back half of the year. And then we've got the cost savings as a result of the restructuring, which is also back half weighted. So when you blend all that together, I'll revisit the points that we made in the prepared comments. From a revenue perspective, you could being between Q1 and Q4 and the story of the book ends of the year.

    我們的年度預測中約有三分之二將在下半年實現。然後,我們透過重組節省了成本,這也是一半的加權。因此,當你將所有這些融合在一起時,我會重新審視我們在準備好的評論中提出的觀點。從收入角度來看,您可能處於第一季和第四季之間,而本書的故事將在年底結束。

  • As I said, there's about $100 million revenue difference. We think between where Q1 will land where Q4 related to those, that delta, you can figure out the pieces in between And then from an EBITDA margin perspective, it could be as much as 200 basis points difference between our first quarter, which will probably be our lowest quarter of the year.

    正如我所說,收入差異約為 1 億美元。我們認為,第一季和第四季之間的差異,可以計算出兩者之間的差異,然後從 EBITDA 利潤率的角度來看,與我們第一季相比,這可能高達 200 個基點,這可能是我們今年最低的一個季度。

  • And the fourth quarter, which should be our best quarter of the year is we're laying out our planning for the year. Now whether that has faced a lot of it.

    第四季應該是我們今年最好的一個季度,我們正在製定全年計劃。現在是否已經面臨了很多這樣的情況。

  • Operator

    Operator

  • Your next question comes from the line of Keith increase going.

    您的下一個問題來自 Keith Increase Going 先生。

  • Keith Gordon - Analyst

    Keith Gordon - Analyst

  • Thank you for taking my questions. Just firstly for me, the $200 million of OpEx savings that seems like that's primarily in SG&A from the guide that's about reduction of 10% to 15% of your legacy cost base. Just wondering, it seems like a pretty significant number of wondering where where those cuts are actually coming from and any commentary you can pull right on opportunities beyond 2025 for further restructuring opportunities.

    感謝您回答我的問題。首先對我來說,2 億美元的營運支出節省似乎主要體現在銷售、一般及行政費用方面,從指南來看,這大約相當於減少了 10% 到 15% 的遺留成本基礎。只是想知道,似乎有相當多的人想知道這些削減實際上來自何處,以及您能否對 2025 年以後進一步重組機會的評論。

  • And then just on NexPlanar And Kevin, you've been more vocal about this potentially reaching $1 billion and a half and revenues in the out years and having a very long tail. I would think that that that implies more of like an out year growth kegger of at least double digit and street obviously hasn't mark flatlining probably on differing LOE. assumptions, but I'm just kind of curious, your guidance for '25, it is greater than $1 billion, but that's pretty much where you are here.

    然後就在 NexPlanar 和 Kevin 身上,您曾多次表示,這項技術在未來幾年內可能達到 15 億美元的收益,並且會產生非常長的尾聲。我認為這更像是未來一年的至少兩位數的增長,而街道顯然沒有在不同的 LOE 上標記持平。假設,但我只是有點好奇,你對 25 年的指導是超過 10 億美元,但這幾乎就是你所在的位置。

  • So I'm just wondering if we should be thinking about growth and the expert on as more in the double digit plus territory and '25.

    所以我只是想知道我們是否應該考慮成長,而專家們則更多地考慮兩位數以上的領域和'25。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • So I'll start with the with the restructuring piece. So we've been a public company now since 21. We undertook some restructuring in 2023, 2024. I would call that belt-tightening this round of restructuring as you point out adjacent more significant. Second, we did look at our organization more holistically. I really did some pretty significant streamlining of our spans and layers and the way that our various functional work together, we've really tightened tightened things up.

    因此我將從重組部分開始。從 21 日起我們就已經成為一家上市公司了。我們在 2023 年、2024 年進行了一些重組。正如您所指出的,我認為這一輪重組的緊縮措施更為重要。其次,我們確實更全面地審視我們的組織。我確實對我們的跨度和層次以及各種功能協同工作的方式做了相當重要的簡化,我們確實使事情變得更加緊密。

  • So the 2025 impact, $200 million run rate of that or two's time, as I said in the prepared comments, the rough split in terms of how we financially report in 2025, you see about 75% of that 200 in our OpEx. And so that's spread over the SG. and AR. and D. line and about 25% would be in COGS.

    因此,2025 年的影響,即 2 億美元的運行率,正如我在準備好的評論中所說,就我們在 2025 年的財務報告而言,粗略地劃分,您會看到這 200 億美元的約 75% 在我們的營運支出中。這已遍佈 SG。和 AR。和 D.線,其中約 25% 將用於銷售成本。

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • In regards to your question on NexPlanar, you've heard me say many times the reasons to believe, and I feel very confident that we won't see at least until the end of the decade, a competitor for next summer months and up. And in 2024, as you rightly stated, that was the best year. We've actually had said 17% growth both outside the US than inside the US and we will look pretty comfortably get beyond $1 billion in 2025.

    關於您對 NexPlanar 的問題,您已經聽我多次說過值得相信的理由,而且我非常有信心,至少在本世紀末之前,我們不會在明年夏季及以後看到競爭對手。正如您所說,2024 年是最好的一年。實際上,我們在美國以外的成長速度比美國國內快 17%,而且我們預計到 2025 年這一數字將輕鬆超過 10 億美元。

  • I think the historical growth rate of this product has been in the high single digit range. I don't expect that to change. But there are certain years where we do certain things like, for example, will you start to see the benefit of the five year indication, hopefully with some BMI language attached to it, which will really open up a variety of new, very attractive segments for us for the next.

    我認為該產品的歷史成長率一直處於高個位數範圍。我並不認為這種情況會改變。但在某些年份,我們會做某些事情,例如,您是否會開始看到五年指徵的好處,希望其中附帶一些 BMI 語言,這將真正為我們在接下來的時間開闢各種新的、非常有吸引力的細分市場。

  • But on the growth opportunities, so could be double digit, low double digits in some years, high single digit in other years. But I think it's a prudent way to say, Look just factor in high single digit growth through the end of the decade. It will get you to somewhere in the neighborhood of $1.1.5 billion, which again, is very different than you see in some of the models out there.

    但就成長機會而言,有些年份可能是兩位數,有些年份可能是低兩位數,有些年份可能是高個位數。但我認為,謹慎的說法是,只考慮本世紀末的高個位數成長。它將達到約 115 億美元,這與現有的一些模型中看到的又有很大不同。

  • But I think as time goes on, it is a show-me story. As time goes on, you'll start to see the of the opportunities that do start to mature. I realize for for next one on for us of at least for the end of the decade, I see it and thereafter, it could easily be longer. If you take the rate of some precedent, it could be significantly longer than that. But I'm going to be more responsible and safe through the end of the decade.

    但我認為隨著時間的推移,這將是一個展示給我看的故事。隨著時間的推移,您將開始看到開始成熟的機會。我意識到,至少對我們來說,下一個十年即將到來,我認為,它可能會持續更長時間。如果以某些先例的速度來計算,這個時間可能會比這長得多。但到本世紀末,我將變得更加負責和安全。

  • Operator

    Operator

  • Your next question comes from the line of who may affect with Evercore ISI.

    您的下一個問題來自於誰可能對 Evercore ISI 產生影響。

  • Unidentified participant 2

    Unidentified participant 2

  • Thanks for squeezing me in. I wanted to focus on the TAM on a two-part question. First, I saw you reported $10 million for US in Q4 from a timing previously. I know the run rate was around $20 million or so on the prior quarters that derma that was reporting. But I do acknowledge you have a partial quarter, there's only two months, but still I wouldn't have thought it would be probably closer to perhaps 15 or so.

    謝謝你擠進我。我想重點討論由兩部分組成的 TAM 問題。首先,我看到您之前報告稱美國第四季的銷售額為 1000 萬美元。我知道皮膚科報告的前幾季的運行率大約是 2000 萬美元左右。但我確實承認你有一個部分季度,只有兩個月,但我仍然不會想到它可能更接近 15 左右。

  • So I wanted to understand better the $10 million number knowing that it was two out of three months. Secondly, I had I'm very intrigued by a comment made today. So specifically, I know you previously said you had at $150 million in sales from a TAM in 2025 today, you said two-thirds will be back half-weighted. So $100 million will be in second half of the year, presumably, which would imply a $50 million to $3 million a quarter in Q4. So is it reasonable to think that your expectation is that the TAM as Q4 run rate will be $200 million to 250 million?

    所以我想更能理解 1000 萬美元這個數字,因為我知道這是三個月中兩個月的數據。其次,我對今天的評論非常感興趣。具體來說,我知道您之前說過,到 2025 年,您的 TAM 銷售額將達到 1.5 億美元,您說三分之二將以半加權形式回歸。因此,大概 1 億美元將出現在今年下半年,這意味著第四季的銷售額將達到 5,000 萬到 300 萬美元。那麼,您預期第四季的 TAM 運行率將達到 2 億至 2.5 億美元,這種預期合理嗎?

  • Juan Camilo - Head of Research and Development and Chief Medical Officer

    Juan Camilo - Head of Research and Development and Chief Medical Officer

  • So your first question in regards to the Q4 numbers, we are becoming a derm event has discussed some customary practice of pulling sales forward in terms of revenue forward in the end of the quarter. For obvious reasons, decided not to do that and get a good start in 2025.

    因此,您關於第四季度數據的第一個問題,我們正在成為一個皮膚病學活動,討論了一些在季度末推動銷售收入向前發展的慣例。出於顯而易見的原因,我們決定不這樣做,而是在 2025 年取得一個好的開始。

  • And so as a result of that kind of just let us know just clean in terms of the overall performance in Q4 so that we could start off, I think, in a very solid, solid fashion with Q1 for the remainder of the year. And you're right, when I start to think about where the opportunities to buy up for this product, we're going to be working on growth that we're going to be working on a number of areas, especially around our with our managed care group, which is best in breed in the market today.

    因此,透過這種方式,我們可以清楚地了解第四季度的整體表現,以便我們能夠以非常穩健的方式在第一季為今年剩餘時間開個好頭。你說得對,當我開始思考購買這款產品的機會在哪裡時,我們將致力於成長,我們將在多個領域開展工作,特別是圍繞我們的管理式醫療集團,這是當今市場上最好的。

  • And they're getting successes as we speak to to get a better treatment in terms of the overall formulary status for the TAM I have regards to ADR. That's a very important thing to essentially lower the usage of things like coupons and other things.

    正如我們所談論的,他們在 TAM 整體處方狀態方面獲得了更好的治療,我對 ADR 表示尊重。這對於從根本上減少優惠券和其他物品的使用是非常重要的事情。

  • So yes, by the end of the by the end of the year, as we start to see successively quarter after quarter, you'll start to see more strength in the product based on some of our managed care work and some of the former Larry work that we're doing, as well as continuing continuing growth in our FCRx growth that we see going on for the product out.

    所以是的,到今年年底,隨著我們開始逐季觀察,您將開始看到產品實力的增強,這得益於我們的一些管理式醫療工作和我們正在進行的一些前拉里工作,以及我們看到的產品 FCRx 增長的持續增長。

  • We've got a really solid 1st month of the year in terms of TRx growth. So we think that that will continue on the go forward for us.

    就 TRx 成長而言,今年第一個月我們取得了非常穩健的成績。因此我們認為,這種趨勢將會持續下去。

  • Operator

    Operator

  • That concludes our Q&A session. I will now turn the conference back over to Kevin Reddy, Chief Executive Officer for closing remarks.

    我們的問答環節到此結束。現在,我將會議交還給執行長凱文·雷迪 (Kevin Reddy) 並請他致閉幕詞。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Thank you, operator, and thanks, everybody, for your questions. Once again, we are really very proud of our 2020 for performance. And in 2024, we achieved our third year of constant currency revenue growth and delivered adjusted EBITDA margin expansion at site the R&D.

    謝謝接線員,也謝謝大家的提問。再一次,我們為 2020 年的表現感到非常自豪。2024 年,我們實現了第三年以固定匯率計算的營收成長,並實現了研發中心調整後的 EBITDA 利潤率擴大。

  • Our 2025 financial guidance reflects the potential for fall fourth year of constant currency revenue growth despite the loss of exclusivity of our second largest product out of that, as we think about 2026 and beyond, we will have that LOE behind us and we will be leveraging the cost savings were taken out this year.

    我們的 2025 年財務指引反映了第四年秋季固定貨幣收入成長的潛力,儘管我們失去了第二大產品的獨家經營權,但當我們考慮 2026 年及以後時,我們將把 LOE 拋在身後,我們將利用今年節省的成本。