Viatris Inc (VTRS) 2024 Q4 法說會逐字稿

Good morning, everyone, and welcome to the Viatris Q4 and full year 2024 earnings call. (Operator Instructions)

大家早安，歡迎參加 Viatris 2024 年第四季和全年財報電話會議。（操作員指令）

Please also note today's event is being recorded. At this time, I'd like to turn the conference call over to Bill Szablewski, Head of Capital Markets. Sir, please go ahead.

另請注意，今天的活動正在記錄。現在，我想將電話會議轉給資本市場主管比爾‧薩布利夫斯基 (Bill Szablewski)。先生，請說。

Good morning, everyone. Welcome to our Q4 2024 earnings call. With us today is our CEO, Scott Smith; CFO, Doretta Mistras; Chief R&D Officer, Philippe Martin; and Chief Commercial Officer Corinne Le Goff.

大家早安。歡迎參加我們的 2024 年第四季財報電話會議。今天和我們在一起的是我們的執行長 Scott Smith；首席財務官，Doretta Mistras；首席研發官 Philippe Martin；以及首席商務官 Corinne Le Goff。

During today's call, we'll be making forward-looking statements on a number of matters, including our financial guidance for 2025 and various strategic initiatives. These statements are subject to risk and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to the most directly comparable GAAP measures.

在今天的電話會議上，我們將就許多事項發表前瞻性聲明，包括 2025 年的財務指導和各種策略舉措。這些聲明受風險和不確定性的影響。我們也將參考某些實際和預期的非公認會計準則財務指標。請參閱今天的幻燈片演示和我們的 SEC 文件以獲取更多信息，包括這些非 GAAP 指標與最直接可比的 GAAP 指標的對帳。

When discussing 2024 actual or reported results, we will be making certain comparisons to 2023 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 and 2023 from the 2023 period.

在討論 2024 年實際或報告結果時，我們將在剝離調整後的營運基礎上與 2023 年實際或報告結果進行某些比較，這排除了外匯匯率的影響，也不包括 2023 年期間在 2024 年和 2023 年完成的剝離的比例結果。

When discussing our expectations for 2025, we will be making certain comparisons to 2024 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 from the 2024 period. We may refer to those as changes on an operational basis.

在討論我們對 2025 年的預期時，我們將根據資產剝離調整後的營運基礎與 2024 年的實際或報告結果進行某些比較，這排除了外匯匯率的影響，也不包括 2024 年期間在 2024 年完成的資產剝離的比例結果。我們可以將其稱為基於操作的變化。

With that, I'll hand the call over to our CEO, Scott Smith.

說完這些，我將把電話交給我們的執行長斯科特史密斯 (Scott Smith)。

Good morning, everyone. 2024 was an important year for Viatris across all three of our strategic pillars.

大家早安。 2024 年對於 Viatris 的所有三大策略支柱來說都是重要的一年。

We saw growth in our base business increasing our new product revenues to $582 million. We completed our planned divestures to simplify and streamline our organization. We returned approximately $825 million in capital shareholders through dividends and share repurchases. We retired approximately $3.7 billion of debt and achieved our long-term gross leverage target. And we expanded our innovative portfolio with 3 new products Selatogrel, Cenerimod and Sotagliflozin, or Sota to help build our pipeline of the future.

我們的基礎業務實現了成長，新產品收入增至 5.82 億美元。我們完成了計劃中的資產剝離，以簡化和精簡我們的組織。我們透過股利和股票回購向資本股東返還了約 8.25 億美元。我們償還了約 37 億美元的債務，並實現了長期總槓桿目標。我們擴大了創新產品組合，增加了 3 種新產品 Selatogrel、Cenerimod 和 Sotagliflozin（簡稱 Sota），以幫助我們建立未來的產品線。

We finished 2024 with a full year revenue growth of 2% on a divestiture adjusted operational basis in line with our guidance. On a reported basis, we had total revenues of approximately $14.7 billion, adjusted EBITDA of approximately $4.7 billion and adjusted EPS of $2.65 per share. Free cash flow is approximately $2.6 billion excluding divestiture-related taxes and transaction costs. All in all, a very good year.

根據我們的預期，我們在 2024 年實現了資產剝離調整後的營運基礎上 2% 的全年收入成長。根據報道，我們的總營收約為 147 億美元，調整後 EBITDA 約為 47 億美元，調整後每股收益為 2.65 美元。不包括資產剝離相關稅費和交易成本，自由現金流約 26 億美元。整體來說，這是非常好的一年。

Before we dive into our 2025 priorities, I want to give you an update on the remediation efforts at our facility in Indore, India, and the estimated impact for this year. The FDA inspected the facility in June. Following the inspection, we immediately began implementing a comprehensive remediation plan to address the FDA feedback.

在我們深入討論 2025 年的優先事項之前，我想向您介紹我們位於印度印多爾的工廠的修復工作的最新情況以及今年的預期影響。FDA 於六月對該設施進行了檢查。檢查之後，我們立即開始實施全面的補救計劃來解決 FDA 的回饋。

The necessary corrective actions are well underway, including but not limited to related personnel actions, and we have engaged independent third party subject matter experts to support our efforts. I assure you we take these matters very seriously, as well as our commitment to quality across our entire network.

必要的糾正措施正在順利進行中，包括但不限於相關人員行動，並且我們已經聘請了獨立的第三方主題專家來支持我們的努力。我向你們保證，我們非常重視這些問題，並且我們致力於保證整個網路的品質。

We recently traveled to Indore to review the progress. I can tell you we are more than halfway through our efforts. We expect to be completed in a few months, at which time we anticipate asking the FDA to conduct a re-inspection of the facility.

我們最近前往印多爾審查進度。我可以告訴你們，我們的努力已經完成一半以上。我們預計將在幾個月內完成，屆時我們預計將要求 FDA 對該設施進行重新檢查。

Received a warning letter and import alert from the FDA at the end of December. The import alert affects 11 actively distributed products in the US, including lenalidomide. The FDA made exceptions subject to certain conditions for 4 products based on shortage concerns. We recently finished interactions with the FDA about potential additional product exceptions, and we do not expect any additional exceptions will be granted at this time.

12月底收到了FDA的警告信和進口警報。此次進口警報影響美國11種活躍分銷的產品，其中包括來那度胺。FDA 基於對短缺的擔憂，對 4 種產品做出了符合特定條件的例外規定。我們最近與 FDA 就潛在的額外產品例外完成了溝通，我們預計目前不會批准任何額外的例外情況。

While product continues to be shipped from the facility to markets outside the US, we currently anticipate some impact on other markets, including parts of our ARV business and emerging markets and to select generic products in Europe. We currently estimate the negative impact on 2025 total revenues to be approximately $500 million and on 2025 adjusted EBITDA to be approximately $385 million. To meet the needs of the patients we serve, we are working closely with our customers to mitigate any supply disruptions, including potential site transfers and third-party arrangements.

雖然產品繼續從工廠運往美國以外的市場，但我們目前預計會對其他市場產生一些影響，包括部分抗愛滋病毒藥物業務和新興市場以及歐洲部分的仿製藥產品。我們目前估計，對 2025 年總營收的負面影響約為 5 億美元，對 2025 年調整後 EBITDA 的負面影響約為 3.85 億美元。為了滿足我們服務的患者的需求，我們正在與客戶密切合作，以減輕任何供應中斷的影響，包括潛在的場地轉移和第三方安排。

Turning our attention to our 2025 priorities, we are very focused on continuing to drive our base business with strong execution across commercial markets, and we are expecting several notable new product launches this year.

將注意力轉向我們的 2025 年重點任務，我們非常專注於繼續透過在商業市場的強勁執行力推動我們的基礎業務，我們預計今年將推出幾款引人注目的新產品。

From a pipeline perspective, we have 10 unique molecules in Phase III clinical development across our portfolio, and we are expecting 6 Phase III readouts this year, including meloxicam, which is being developed as a potential opioid sparing treatment in acute pain. In addition, we expect to achieve several important late-stage development milestones for our three innovative assets Selatogrel, Cenerimod and Sota.

從產品線角度來看，我們的產品組合中共有 10 種獨特分子處於 III 期臨床開發階段，預計今年將有 6 種 III 期結果出爐，其中包括美洛昔康，該藥物正在開發中，作為治療急性疼痛的潛在阿片類藥物節約治療藥物。此外，我們預計將為我們的三種創新資產 Selatogrel、Cenerimod 和 Sota 實現幾個重要的後期開發里程碑。

To preserve the ongoing continuity of the development programs for Selatogrel and Cenerimod, we have updated certain terms of our original global research and development collaboration with Idorsia. Under the updated terms, we will receive the rights to additional territories for Cenerimod, including important markets in Asia.

為了維持 Selatogrel 和 Cenerimod 開發計畫的持續性，我們更新了與 Idorsia 原有全球研發合作的某些條款。根據更新後的條款，我們將獲得Cenerimod在其他地區的權利，包括亞洲的重要市場。

A reduction in certain contingent milestone payments which will help improve the long-term economics of these assets and certain other considerations in exchange for assuming a portion of a Idorsia's remaining development cost obligation. We continue to be excited by the promise of these two assets and we will take full control over the development to help ensure development timelines remain on track. From a capital allocation perspective, we said that we expect our approach to be equally balanced between capital return and business investment over the next 3 to 5 years, and then any given year, we may prioritize one over the other.

減少某些或有里程碑付款，這將有助於改善這些資產的長期經濟效益，並承擔某些其他對價，以換取承擔 Idorsia 部分剩餘開發成本義務。我們繼續對這兩項資產的前景感到興奮，我們將全面控制開發，以幫助確保開發時間表保持正常進行。從資本配置的角度來看，我們預計我們的方法將在未來 3 到 5 年內在資本回報和業務投資之間取得平衡，然後在任何一年，我們都可能優先考慮其中一個。

In 2025, we are prioritizing returning capital to shareholders. We will continue to support our dividend and are targeting at least $500 million to $650 million in share repurchases this year. As we progress through the year, we expect to have additional flexibility, and as a reminder, we still have $1.5 billion in share repurchase authorization available to us. From business development perspective, we will target a creative regional opportunities that leverage our unique commercial and R&D infrastructure and capabilities.

2025年，我們的首要任務是向股東返還資本。我們將繼續支持我們的股息，並計劃今年回購至少 5 億至 6.5 億美元的股票。隨著一年的進展，我們期望擁有更多的靈活性，提醒一下，我們仍然有 15 億美元的股票回購授權可供使用。從業務發展角度來看，我們將瞄準富有創意的區域機會，利用我們獨特的商業和研發基礎設施和能力。

Finally, we've begun an enterprise-wide initiative to review our global infrastructure and identify additional cost savings. We expect this program to deliver OPEC savings in 2026 and beyond. Later this year, we'll hold an investor day to talk about our long-term outlook, how we are advancing our base in innovative pipelines, and the progress we are making on our enterprise-wide review.

最後，我們啟動了一項全企業範圍的計劃，以審查我們的全球基礎設施並尋找額外的成本節約手段。我們預計該計劃將在2026年及以後實現OPEC的節約。今年晚些時候，我們將舉辦投資者日活動，討論我們的長期前景、我們如何推進創新管道的基礎以及我們在企業範圍審查中取得的進展。

Overall, I'm proud of what we accomplished in 2024 and I'm very confident in our future. We have our arms around the situation at Indore. In 2025, we have significant opportunity to drive our base business, execute on our pipeline, return capital to shareholders, and position ourselves for growth in 2026 and beyond.

總的來說，我為我們在 2024 年所取得的成就感到自豪，我對我們的未來充滿信心。我們已掌握了印多爾局勢。2025 年，我們有重大機會推動我們的基礎業務、執行我們的計劃、向股東返還資本，並為 2026 年及以後的成長做好準備。

Now, I'll turn it over to Philippe to share an update on how we are advancing our pipeline.

現在，我將讓菲利普分享我們推進管道的最新進展。

Thank you, Scott. Our based business pipeline continues to be highly diversified across core generics, complex generics, and novel products.

謝謝你，斯科特。我們的基礎業務管道持續高度多樣化，涵蓋核心仿製藥、複雜仿製藥和新產品。

This robust and deep pipeline representing approximately 100+ emissions annually is the backbone of our ability to deliver more than $450 million in new product revenues for each of the last 5 years. We made great progress in '24, delivering $582 million in new product revenues, setting us up very nicely to hit our target range of $450 million to $550 million in 2025.

這個強大而深入的產品線每年約有 100 多個產品系列，是我們在過去 5 年中每年實現超過 4.5 億美元新產品收入的支柱。我們在24年取得了巨大進步，實現了5.82億美元的新產品收入，為我們在2025年實現4.5億至5.5億美元的目標做好了充分準備。

This is a particularly important year from an R&D and scientific execution perspective, as we expect to receive approvals on a number of complex injectables that we have been steadily and strategically developing. These include iron sucrose, octreotide, and liraglutide. Glucagon was approved last year and is actively being launched.

從研發和科學執行的角度來看，這是特別重要的一年，因為我們預計將獲得我們一直在穩步和策略性開發的多種複雜注射劑的批准。這些包括蔗糖鐵、奧曲肽和利拉魯肽。胰高血糖素去年已獲批准，目前正積極上市。

These are difficult to develop and difficult to manufacture medicines, and we are proud of the scientific and development expertise we have built in this area. We plan to continue to leverage this differentiated platform as we further advance our base business pipeline.

這些都是難以開發和製造的藥物，我們為在該領域建立的科學和開發專業知識感到自豪。我們計劃在進一步推進我們的基礎業務管道的同時繼續利用這個差異化的平台。

In parallel, we're getting these complex injectables to approval, we are also very focused on progressing our novel and life cycle management programs. We have a number of Phase III readouts anticipated in 2025.

同時，我們正在獲得這些複雜注射劑的批准，我們也非常注重推進我們的新穎的生命週期管理計劃。我們預計 2025 年會有一系列第三階段的讀數。

The most near-term opportunity is Effexor for generalized anxiety disorder in Japan. We announced positive top line results of our randomized double-blind placebo-controlled Phase III study last year and recently received positive results from the Phase III open label long-term extension required for approval in Japan. We anticipate filing our submission in the first half of this year.

近期的機會是日本用於治療廣泛性焦慮症的 Effexor。去年，我們公佈了隨機雙盲安慰劑對照 III 期研究的積極頂線結果，最近又獲得了日本批准所需的 III 期開放標籤長期延長研究的積極結果。我們預計將在今年上半年提交提案。

Another key program is for Xulane low dose, which is a transdermal patch that is being developed to offer women a low dose estrogen combination birth control option. We expect our Phase IIIII readout in the first half of this year.

另一個重要項目是 Xulane 低劑量，這是一種透皮貼劑，正在開發中，為女性提供低劑量雌激素組合避孕選擇。我們預計第三階段的成果將在今年上半年公佈。

We received positive results from our first meloxicam Phase III bunionectomy study and are feeling optimistic about our development program as we await our second Phase III readout in herniorrhaphy, which is anticipated later this year. We believe that this novel, fast-acting oral formulation of meloxicam has the potential to be an important opioid sparing treatment option for patients with acute pain.

我們從第一階段美洛昔康拇囊切除術研究中獲得了積極的結果，並且對我們的開發計劃感到樂觀，我們正在等待預計在今年晚些時候進行的疝修補術第二階段 III 期讀數。我們相信，這種新型、速效的美洛昔康口服製劑有可能成為急性疼痛患者重要的鴉片類藥物節約治療選擇。

Now, moving to our innovative pipeline, beginning with Eye Care. We are continuing to advance our ophthalmology programs with these three key registrational readouts expected in 2025. We are on track to receive top line data for our MR139 of Pemecrolimus Phase III study for blepharitis in the first half of this year. We also have recently completed enrollment for our Phase IIIII study evaluating MR-141 for Presbyopia and expect to receive top line results in the first half of this year.

現在，讓我們轉向我們的創新管道，從眼部護理開始。我們將繼續推進我們的眼科項目，預計 2025 年將公佈這三個關鍵的註冊數據。我們預計在今年上半年收到瞼緣炎的 Pemecrolimus III 期研究 MR139 的頂線數據。我們最近也完成了評估 MR-141 治療老花眼的 IIIIII 期研究的招募，預計將在今年上半年獲得頂線結果。

Additionally, our partner recently received fast track designation from the FDA for their investigational new drug application for MR-142, which is being developed for the treatment of visual loss in low light conditions associated with Keratorefractive Surgery. A substantial subset of these patients has night driving impairment for which there is no label treatment, thereby supporting the fast track designation. The development of this asset is also progressing well and we anticipate completing Phase III enrollment and receiving top line results in the first half of this year.

此外，我們的合作夥伴最近獲得了 FDA 對 MR-142 新藥研究申請的快速通道認定，該藥物正在開髮用於治療與角膜屈光手術相關的弱光條件下的視力喪失。這些患者中有相當一部分患有夜間駕駛障礙，且目前尚無標籤治療方法，因此支持快速通道指定。該資產的開發也進展順利，我們預計將在今年上半年完成第三階段的註冊並獲得頂線結果。

And Selatogrel and Cenerimod, we continue to be focused on increasing and accelerating trial enrollment enrollment for both SOSMI and Opus. Recruitment for Opus is well under way with plans to complete enrollment in the second half of this year.

對於 Selatogrel 和 Cenerimod，我們將繼續致力於增加和加速 SOSMI 和 Opus 的試驗招募。Opus 的招募工作正在順利進行中，並計劃在今年下半年完成招生。

We continue to submit data from the Phase II care study for publication and 3 abstracts have recently been accepted for presentation at 2 major congresses. Lupus 2025 and Pena 2025 discover the multifaceted immunomodulatory properties of Cenerimod and subgroup analysis from the Phase II care study on quality of life and impact on fatigue.

我們繼續提交第二階段護理研究的資料以供發表，最近有 3 篇摘要已被接受在 2 個主要會議上發表。Lupus 2025 和 Pena 2025 發現了 Cenerimod 的多方面免疫調節特性，並從 II 期護理研究中對生活品質和對疲勞的影響進行了亞組分析。

Regarding Selatogrel, the SOSMI trial is progressing according to previously communicated timelines. We have scaled up trial recruitment and increased awareness of the study. We are continuing to build on our legacy in this space and actively engage key opinion leaders and the broader cardiovascular community at key medical meetings around the world.

關於 Selatogrel，SOSMI 試驗正在按照先前傳達的時間表進行。我們擴大了試驗招募規模並提高了人們對該研究的認識。我們將繼續在這一領域發揚我們傳統，並在世界各地重要的醫學會議上積極與關鍵意見領袖和更廣泛的心血管界進行交流。

Moving to Sotagliflozin, we are pleased with the recent publication in The Lancet Diabetes and Endocrinology. This data provides strong evidence of Sotagliflozin's clinical benefit in reducing major adverse cardiovascular events or MAC in patients with Type 2 diabetes, CKD, and high cardiovascular risk.

談到索他格列淨，我們對《柳葉刀糖尿病與內分泌學》雜誌最近發表的文章感到非常高興。這些數據為索他格列淨在減少第 2 型糖尿病、CKD 和高心血管風險患者的主要不良心血管事件或 MAC 方面的臨床益處提供了有力證據。

The findings show that Sotagliflozin significantly and meaningfully reduces maize versus placebo, demonstrating early and broad cardiovascular protection in this population. Sotagliflozin is the first SGLT inhibitor to show significant reduction in both MI and stroke, highlighting the potential role of SGLT-1 inhibition in reducing ischemic events, an important distinction from selective SGLT-2 inhibitors.

研究結果顯示，與安慰劑相比，Sotagliflozin 可顯著且有意義地降低玉米，從而證明其對該族群具有早期和廣泛的心血管保護作用。Sotagliflozin 是第一個顯示出顯著減少心肌梗塞和中風的 SGLT 抑制劑，凸顯了 SGLT-1 抑制在減少缺血事件方面的潛在作用，這是與選擇性 SGLT-2 抑制劑的重要區別。

We are now collaborating with our partner Lexicon to explore next steps, including a potential label expansion to increase patient access as we continue to remain on track for our regulatory submissions starting in 2025 in key ex US markets. We will be leveraging the dossier that led to FDA's approval and expect registration in these markets starting in 2026.

目前，我們正在與合作夥伴 Lexicon 合作探索下一步行動，包括潛在的標籤擴展以增加患者的使用機會，同時我們將繼續按計劃從 2025 年開始在美國以外主要市場進行監管提交。我們將利用獲得 FDA 批准的檔案，並預計從 2026 年開始在這些市場進行註冊。

To recap, our R&D strategy is grounded in being disciplined about executing our near-term programs while preparing for the future. We have a strong focus on advancing our base business and innovative pipelines across multiple fronts with important complex generics approval, Phase III data readouts, and key development milestones in our novel and innovative pipelines all expected this year. And we are continuing to actively build our GLP-1 pipeline and supply chain, which we will share more information about at our upcoming investor day.

總而言之，我們的研發策略的基礎是嚴格執行我們的近期計劃，同時為未來做好準備。我們高度重視推進我們的基礎業務和多個方面的創新管道，預計今年將獲得重要的複雜仿製藥批准、第三階段數據讀數以及新穎和創新管道的關鍵開發里程碑。我們正在繼續積極建立我們的 GLP-1 管線和供應鏈，我們將在即將到來的投資者日上分享更多相關資訊。

With that, I'll hand it over to Corinne.

說完這些，我就把它交給科琳 (Corinne)。

Thank you, Philippe. I'd like to start by outlining our three commercial priorities in 2025.

謝謝你，菲利普。首先，我想概述我們 2025 年的三個商業重點。

First is driving the best business. 2024 was a strong year. All commercial segments grew year over year operationally. We aim to continue this momentum with focused execution in every aspect of the business to maximize the potential of our broad, generic, and brain portfolios. This means continued attention on delivering high customer service levels and leveraging our global healthcare gateway and regional capabilities and infrastructure to expand patient access.

第一是推動最佳業務。 2024 年是強勁的一年。所有商業部門的營運規模均較去年同期實現成長。我們的目標是繼續保持這一勢頭，重點執行業務的各個方面，以最大限度地發揮我們廣泛、通用和智力投資組合的潛力。這意味著我們要繼續專注於提供高水準的客戶服務，並利用我們的全球醫療保健入口網站和區域能力和基礎設施來擴大病患的就醫機會。

Our second priority is to execute our product launches. We're expecting a number of new products coming this year, such as our complex injectables. In total, we are tracking more than 150 generic launches globally, and our aim is to ensure commercial success for each launch. The fundamentals of our business are strong, and we are confident we will deliver the expected $450 million to $550 million in new product revenues.

我們的第二個任務是執行我們的產品發布。我們預計今年將會推出一些新產品，例如我們的複合注射劑。總的來說，我們正在追蹤全球 150 多個仿製藥的發布，我們的目標是確保每次發布都能取得商業成功。我們的業務基礎強勁，我們有信心實現預期的 4.5 億至 5.5 億美元的新產品收入。

Our third priority is preparing the future business. We are building upon our strong commercial infrastructure by enhancing our innovative product commercialization capabilities and expertise across key markets. And we are developing global commercialization strategies for innovative and novel pipe and assets.

我們的第三個優先事項是做好未來的業務準備。我們正在透過增強我們在主要市場的創新產品商業化能力和專業知識來建立我們強大的商業基礎設施。我們正在為創新和新型管道和資產制定全球商業化策略。

Turning to our outlook for the year. As we heard from Scott, we are expecting an approximate $500 million revenue impact related to Indore, affecting mostly the US and emerging markets. In 2025, we expect total revenues to decline approximately 1%.

談談我們對今年的展望。正如我們從斯科特那裡聽到的，我們預計印多爾的收入影響約為 5 億美元，主要影響美國和新興市場。2025 年，我們預計總收入將下降約 1%。

Now, let's dive into the geographic segments starting with Developed Markets.

現在，讓我們從已開發市場開始深入了解地理細分。

Europe is expected to grow year over year. I want to highlight some of the key positive drivers behind this anticipated performance. First, we expect new product launches in both our brand and generic portfolios, including carryover benefits from the [adovastatinacetamide] combination and rivaroxaban. Then the continued performance of our thrombosis's portfolio as well as key brands like [Crayon and Bruin]. And finally, we anticipate further volume growth in key markets including Italy and France and strong generic performance across our diverse portfolio.

預計歐洲將逐年成長。我想強調一下這項預期表現背後的一些關鍵正面驅動因素。首先，我們預期我們的品牌和仿製藥產品組合中都會推出新產品，包括來自[阿伐他汀乙醯胺]組合和利伐沙班的延續效益。然後，我們的血栓產品組合以及關鍵品牌的持續表現，例如[蠟筆和熊]。最後，我們預計包括義大利和法國在內的主要市場的銷售將進一步成長，並且我們多元化產品組合的仿製藥將表現強勁。

North America is expected to decline year over year, which is driven by the Indore impact and expected competition on certain generics, including Xulane, [leytrium acetate], and [prednisolone]. Our focus is to continue to capitalize on the strength of our complex generics portfolio with a stable contribution of products like Dixella and Breyna, as well as continuing the growth trajectory of promoted brands like Yupelri. And we are actively planning for several new launches during the course of the year in the complex infectable space, including iron sucrose and octreotide plus glucagon, which we are in the midst of launching.

北美地區預計將同比下降，這是由於印多爾的影響以及某些仿製藥的預期競爭，包括 Xulane、[醋酸萊特林] 和[潑尼松龍]。我們的重點是繼續利用我們複雜的仿製藥產品組合的優勢，穩定貢獻 Dixella 和 Breyna 等產品，並延續 Yupelri 等推廣品牌的成長軌跡。我們正在積極計劃今年在複雜感染領域推出幾種新產品，包括蔗糖鐵和奧曲肽加胰高血糖素，這些產品我們正在推出中。

The emerging market segment is expected to grow year over year, primarily driven by further expansion of our cardiovascular portfolio in Latin America, as well as expansion in key markets such as Turkey, India, Korea, Brazil, and emerging Asia, and volume growth on our overall base portfolio.

新興市場部分預計將實現同比增長，主要得益於我們在拉丁美洲心血管產品組合的進一步擴大，以及土耳其、印度、韓國、巴西和亞洲新興市場等主要市場的擴張，以及我們整體基礎產品組合的銷售增長。

Moving to [Gens], similar to 2024, this year, we expect continuing impacts from government-driven price regulations in Japan and Australia, as well as from a change in Japan's reimbursement for off patent brands that accelerated generic conversion. While we are forecasting [Gens] to decline in 2025, we continue to benefit from ongoing strong volume growth from key brands and the expansion of our generic business, including through ongoing business development efforts.

轉向 [Gens]，與 2024 年類似，我們預計今年日本和澳洲政府推動的價格監管以及日本對加速仿製藥轉換的非專利品牌報銷變化將繼續產生影響。雖然我們預測 [Gens] 將在 2025 年下降，但我們仍將繼續受益於主要品牌持續強勁的銷售成長以及仿製藥業務的擴張，包括透過持續的業務開發努力。

Japan is a key market, and we are well underway preparing for the future. We are building our commercialization plans around the number of innovative and novel assets such as Effexor for generalized anxiety disorder, Nefecon, Cenerimod, Selatogrel, and Sotagliflozin.

日本是我們的重要市場，我們正在為未來做好準備。我們正在圍繞多種創新和新型資產制定商業化計劃，例如用於治療廣泛性焦慮症的 Effexor、Nefecon、Cenerimod、Selatogrel 和 Sotagliflozin。

And lastly, in Greater China, we expect to deliver year-over-year growth in 2025 stemming from the continued patient demand for a portfolio of iconic brands addressing chronic diseases that are more and more prevalent in China's growing aging population. Our significant presence and leading organization in China, as well as our commitment to patient access, allow us to meet expanding healthcare demands. In addition, we expect to deliver on our pipeline with new product launches of Dymista and Breyna in China.

最後，在大中華區，我們預計到 2025 年將實現同比增長，這得益於患者對一系列針對中國日益增長的老齡化人口中越來越普遍的慢性病的標誌性品牌的持續需求。我們在中國的重要影響力和領先的組織結構，以及我們對患者就醫的承諾，使我們能夠滿足日益增長的醫療保健需求。此外，我們也希望在中國推出 Dymista 和 Breyna 的新產品。

By continuing to maximize our well-established commercial presence across multiple channels including e-commerce, retail, and private hospitals, we expect to be able to absorb the impacts from potential government-implemented healthcare policy regulations. Overall, we are confident we will be able to deliver on our 2025 commitments to driving the base business and executing our new product launches while preparing for successful future innovative launches.

透過持續最大限度地發揮我們在電子商務、零售和私人醫院等多個管道的成熟商業影響力，我們期望能夠吸收政府實施的醫療政策法規可能帶來的影響。整體而言，我們有信心履行 2025 年的承諾，推動基礎業務和執行新產品的發布，同時為未來成功的創新發布做好準備。

With that, I'll turn the call to the Doretta.

說完這些，我就把電話轉給 Doretta。

Thank you. Building on the team's comments around our operational performance, I'll briefly highlight full-year and fourth-quarter results. As a reminder, my commentary on our financial performance will be on a divestiture adjusted operational basis.

謝謝。根據團隊對我們營運表現的評論，我將簡要介紹全年和第四季的業績。提醒一下，我對我們財務表現的評論將基於資產剝離調整後的營運基礎。

We reported 2024 total revenues of $14.7 billion, which was up 2% year over year. This reflects growth across all segments and new product revenues of $582 million, which was at the high end of our increased range.

我們報告 2024 年總收入為 147 億美元，年增 2%。這反映了所有部門的成長和 5.82 億美元的新產品收入，處於我們成長範圍的高點。

Adjusted EBITDA was $4.7 billion, which benefited from adjusted gross margins of 58%, also at the high end of our range, driven by strong brands and complex generics performance. As it specifically relates to the fourth quarter, total revenues of $3.5 billion were in line with our expectations and grew 1%.

調整後的 EBITDA 為 47 億美元，受益於調整後 58% 的毛利率，也處於我們範圍的高端，這得益於強大的品牌和複雜的仿製藥表現。具體到第四季度，總營收 35 億美元符合我們的預期，成長了 1%。

We saw continued momentum and growth across China, developed markets, and emerging markets. Our global generics business grew 2%, driven by new product launches and complex products. Gross margins were in line with expectations and moderated in the fourth quarter due to expected segment and product mix.

我們看到中國、已開發市場和新興市場持續保持成長動能。在新產品發布和複雜產品的推動下，我們的全球仿製藥業務成長了 2%。毛利率符合預期，且由於預期的細分市場和產品組合，第四季度毛利率有所放緩。

We had a strong quarter of free cash flow totaling $685 million excluding the impact from divestiture costs and taxes. Our free cash flow and proceeds from the divestitures were used to pay down approximately $1.4 billion in debt, which enabled us to achieve our gross leverage target, ending the year at approximately 2.9 times.

我們本季的自由現金流表現強勁，除去資產剝離成本和稅收的影響，總額達到 6.85 億美元。我們的自由現金流和資產剝離所得用於償還約 14 億美元的債務，這使我們能夠實現總槓桿率目標，年底時槓桿率約為 2.9 倍。

Now that we've closed the year, we are also providing an estimate of our 2024 results on an ex divestiture basis. These estimates exclude the benefit from the divested businesses totaling approximately $490 million in total revenue and $255 million in adjusted EBITDA.

現在我們已經結束了這一年，我們還將根據剝離後的數據提供 2024 年業績的估計。這些估算不包括剝離業務帶來的收益，總計約 4.9 億美元總收入和 2.55 億美元調整後 EBITDA。

Moving to our plan for 2025, I'll summarize the key drivers to give you a full picture of the year ahead.

談到我們的 2025 年計劃，我將總結關鍵驅動因素，讓您全面了解未來一年的情況。

Given the continued strength of the dollar, we have assumed an FX headwind of approximately 2% to 3% on total revenues. As a reminder, approximately 75% of our revenues occur outside of the US. Excluding the impact of Indore, we expect our operational revenues to benefit from continued momentum and strong fundamentals, primarily in Europe, China, and emerging markets. These trends give us confidence in the continued strength of our base business going forward.

鑑於美元持續走強，我們預計外匯逆風將對總收入造成約 2% 至 3% 的負面影響。提醒一下，我們大約 75% 的收入來自美國以外。除印多爾的影響外，我們預計我們的營運收入將受益於持續的發展動能和強勁的基本面，主要是在歐洲、中國和新興市場。這些趨勢使我們對未來基礎業務的持續強勁充滿信心。

And as you heard from Scott with respect to Indore, ongoing remediation has been an all hands effort and is a top priority for our organization. We take the quality of our products very seriously and are making progress on the remediation plan, including the transfer of products across internal sites and with third parties where deemed possible and appropriate.

正如您從斯科特那裡聽到的關於印多爾的情況，持續的補救工作需要全員共同努力，也是我們組織的首要任務。我們非常重視產品質量，並正在製定補救計劃，包括在內部站點之間以及在可能和適當的情況下與第三方轉移產品。

Discussions with the FDA and our customers have been ongoing and have evolved to a point where we now have clarity on the products and scope and the anticipated associated financial impact which we have included in our guidance. We estimate an impact of approximately $500 million to 2025 total revenue and $385 million to adjusted EBITDA. This includes estimated penalties and supply disruptions of approximately $100 million, which we believe are mostly short-term in nature.

我們與 FDA 和客戶的​​討論一直在進行中，目前我們已經明確了產品和範圍以及預期的相關財務影響，並將其納入我們的指導方針中。我們估計這將對 2025 年的總收入產生約 5 億美元的影響，對調整後的 EBITDA 產生約 3.85 億美元的影響。其中包括估計約 1 億美元的罰款和供應中斷，我們認為這些損失大多是短期的。

Lenalidomide, which after discussions with the FDA was not granted an exception, is the largest product impacted and represents approximately 40% of the total revenue impact and 50% of the total adjusted EBITDA impact given its margin profile. Also, based upon the existing settlement agreements with generic manufacturers, we expect this product will face significant additional generic competition in early 2026.

來那度胺在與 FDA 討論後未獲豁免，是受影響最大的產品，考慮到其利潤率，其收入影響約佔總收入的 40%，調整後 EBITDA 總影響的 50%。此外，根據與仿製藥製造商現有的和解協議，我們預計該產品將在 2026 年初面臨更大的仿製藥競爭。

In Europe, we expect limited impact to select generic products. We believe this impact to be short term and expect to recapture some of this volume in the future. In emerging markets, we anticipate our lower margin ARV business to experience certain disruptions over the short term, and we estimate an impact on total revenue of approximately $125 million.

在歐洲，我們預計選擇仿製藥產品所受到的影響有限。我們認為這種影響是短期的，並預計未來將恢復部分規模。在新興市場，我們預期利潤率較低的 ARV 業務將在短期內遭遇一定的干擾，估計對總收入的影響約為 1.25 億美元。

Moving to the drivers of gross margins and our adjusted EBITDA and EPS guidance. We expect gross margins to be impacted by Indore, normal based business price erosion, and an increase in some product supply costs. Partially offsetting this impact is the expected benefit from segment mix.

轉向毛利率的驅動因素以及我們的調整後 EBITDA 和 EPS 指引。我們預計毛利率將受到印多爾、正常業務價格下滑以及部分產品供應成本上漲的影響。預計細分市場組合帶來的收益將部分抵消這種影響。

As it relates to our outlook for SG&A and R&D, we are taking a disciplined approach to managing our expenses and allocation of resources. Total operating expenditures are expected to decline as we work to optimize the portfolio and reduce stranded costs associated with the divestitures. Our guidance assumes a reduction of approximately $150 million predominantly benefiting SG&A.

由於它與我們對銷售、一般及行政開支和研發支出的展望有關，我們採取嚴謹的方式來管理我們的費用和資源分配。隨著我們努力優化投資組合併減少與資產剝離相關的擱淺成本，預計總營運支出將會下降。我們的指導假設減少約 1.5 億美元，主要惠及銷售、一般及行政開支。

And with respect to Idorsia, as Scott mentioned, we have amended the collaboration agreement. As a result, we expect to incur an incremental R&D expense of approximately $100 million in 2025. In exchange, we have received a $250 million reduction in contingent milestones, of which $200 million is from future development milestones. We have also gained additional territory rights for Cenerimod. We expect our effective tax rate to increase by 150 basis points in 2025 due to anticipated impacts from Pillar Two.

關於 Idorsia，正如 Scott 所提到的，我們已經修改了合作協議。因此，我們預計 2025 年的研發費用將增加約 1 億美元。作為交換，我們的或有里程碑減少了 2.5 億美元，其中 2 億美元來自未來的發展里程碑。我們還獲得了 Cenerimod 的額外領土權利。由於預期第二支柱的影響，我們預計 2025 年我們的有效稅率將增加 150 個基點。

A few points on our expectations for free cash flow and cash available for deployment in 2025. We expect strong free cash flow generation of approximately $2 billion, which takes into account IndorE remediation and foreign exchange totaling approximately $300 million. Net of taxes and transaction costs associated with the divestitures, we estimate that we'll have approximately $1.7 billion available for deployment throughout the year.

關於我們對 2025 年自由現金流和可供部署現金的預期，有幾點值得注意。我們預計將產生約 20 億美元的強勁自由現金流，其中考慮到 IndorE 修復和外匯總額約 3 億美元。扣除與資產剝離相關的稅款和交易成本後，我們估計全年可供部署的資金約為 17 億美元。

Consistent with our stated strategy, we continue to prioritize capital return in 2025 with a focus on share repurchases. As such, we expect to repurchase between $500 million and $650 million throughout the year, preserving flexibility to the upside. With the approved annual dividend policy of $0.48 per share, we expect to return over $1 billion of capital to shareholders, nearly 70% of our available capital.

與我們既定的策略一致，我們將繼續優先考慮 2025 年的資本回報，重點是股票回購。因此，我們預計全年將回購 5 億至 6.5 億美元，以保留上行彈性。根據批准的每股 0.48 美元的年度股息政策，我們預計將向股東返還超過 10 億美元的資本，占我們可用資本的近 70%。

Now, a few comments regarding phasing of our guidance. Total revenue is expected to be higher in the second half, driven by the back weighted launch of new products and normal product seasonality.

現在，針對我們指導的分階段提出一些評論。受新產品後續推出及產品季節性正常的推動，預計下半年總收入將會更高。

We expect operating expenses to be evenly phased between the first half and second half. Taking into account phasing of revenue and margin, we expect adjusted EBITDA and adjusted EPS to also be more heavily weighted towards the second half. And as we think about the sequential quarterly roll forward, we expect the first quarter levels to step down from the fourth quarter, attributed to lower net sales from Indore related products and volume and seasonal impacts in Europe and [Gens].

我們預計上半年和下半年的營運費用將會平均分佈。考慮到收入和利潤率的分階段變化，我們預計調整後的 EBITDA 和調整後的 EPS 也將更受下半年的影響。當我們考慮季度連續滾動時，我們預計第一季的水平將低於第四季度，這歸因於印多爾相關產品的淨銷售額下降以及歐洲和[根]。

Finally, we will continue to be disciplined with our financial policy and remain in a very strong position given the breadth and diversity of our global portfolio, strong-based business fundamentals, expected significant free cash flow generation, and efficient low coupon fixed rate capital structure. Looking ahead, we have laid out a clear and transparent plan for this year, and I have confidence that our strong foundation will position us for long term success. We look forward to updating you each quarter on our progress and being available for your questions.

最後，我們將繼續嚴格執行我們的財務政策，並鑑於我們全球投資組合的廣度和多樣性、強勁的業務基本面、預期的顯著自由現金流產生以及高效的低息固定利率資本結構，保持非常強勢的地位。展望未來，我們為今年制定了清晰透明的計劃，我相信，我們堅實的基礎將為我們取得長期成功奠定基礎。我們期待每季向您通報我們的進度並解答您的問題。

And with that, I'll hand it back to the operator to begin the Q&A.

說完這些，我將把麥克風交還給接線員，開始問答環節。

(Operator Instructions)

（操作員指令）

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

So, first, I guess on the warning letter and the remediation, I guess any time there is a warning letter, you can't help but wonder are there potential issues with quality control at other facilities. So I guess, can you just talk about your level of confidence that this is something that is contained, to endure and not something that you're worried about in terms of 483s and potential warning letters at other sites. So, that's number one.

因此，首先，我想關於警告信和補救措施，我想任何時候收到警告信，你不禁會想知道其他設施的品質控制是否有潛在問題。所以我想，您能否談談您的信心水平，即這種現像是可以控制的、可以持續的，而不是您擔心的 483 和其他站點的潛在警告信。這是第一點。

Number two on Cenerimod and Selatogral, just given your comments on enrollment, can we assume that these are going to be '27 events in terms of the data? It doesn't look like '26 may happen, but I just wanted to get your thoughts there regarding the timing of Phase III.

第二個關於 Cenerimod 和 Selatogral 的問題，根據您對招募的評論，我們能否從數據上假設這些將是『27 個事件』？看起來 26 年可能不會發生，但我只是想了解您對第三階段時間的看法。

And then just lastly, just given your comments on capital deployment and your past comments and activity on M&A, I guess my question here is going forward, what does Viatris want to be longer term? I mean, do you want to lean more into brands? Are you looking more at returning capital to shareholders and comfortable with the current business? I guess just a bigger picture question in terms of where you want to take the company?

最後，鑑於您對資本配置的評論以及您過去對併購的評論和活動，我想我的問題是，Viatris 的長期目標是什麼？我的意思是，你想更依賴品牌嗎？您是否更重視向股東返還資本並對目前的業務感到滿意？我猜這只是一個更大的問題，關於你想帶領公司走向何方？

So first of all, your first question around security and thoughts around other facilities. There were three facilities inspected in '24. We've talked about Indore here where we got the warning letter and import alert. There was also an inspection in Carroll Park in Australia and that has been closed out. I know with voluntary issues there for us to be able to handle no warning letter issued there at all. So that was, that's closed out in terms of Carroll Park.

首先，您的第一個問題是關於安全性以及對其他設施的想法。'24年共有三個設施接受了檢查。我們在這裡討論了印多爾的情況，我們在那裡收到了警告信和進口警報。在澳洲卡羅爾公園也進行了一次檢查，目前已經結束。我知道，透過自願問題，我們能夠處理那裡發出的根本不存在的警告信。所以，就卡羅爾公園而言，這已經結束了。

The third facility is in Nasha, India, and there was an inspection there. The classification of that is pending. And so, we're waiting to hear back there. All other facilities within the network, and there's 26 facilities in our network. All other facilities are within acceptable compliance status with all the relevant health authorities. So that's where we're staying. We're waiting to hear back on (inaudible), but everything else is in compliance at this point in time.

第三個工廠在印度納沙，那裡已經進行了檢查。此事的分類尚未確定。因此，我們正在等待回應。網路內的所有其他設施，我們的網路中共有 26 個設施。所有其他設施均符合所有相關衛生當局的可接受的合規狀態。所以我們就住在那裡。我們正在等待（聽不清楚）的回复，但目前其他一切都符合要求。

And again, this is the Indore situation was was 1 out of 26 facilities in our network, an important one, not to diminish that, but 1 of 26 within the network. I'll go to capital allocation again and I'll kick it over to Phillipe to talk a little bit about Cenerimod.

再說一次，印多爾的情況是，它是我們網路中 26 個設施中的 1 個，它是一個重要的設施，並不是要貶低它，而是它是網路內 26 個設施中的 1 個。我將再次討論資本配置，並將其交給 Phillipe 來談談 Cenerimod。

A lot of growth, our capital allocation plans have not changed at all. Over the next 5 years, we plan to allocate 50% to shareholders, dividends, share buybacks, 50% to business development, and that business development will be both supporting regional business development, accretive transactions to build our revenue and our dividend, also innovative programs to add to the pipeline.

很大的成長，我們的資本配置計畫一點都沒有改變。在未來 5 年內，我們計劃將 50% 分配給股東、股息和股票回購，50% 用於業務發展，業務發展將支持區域業務發展、增值交易以增加我們的收入和股息，同時也將創新項目添加到通路中。

In any one year, our priorities may be a little bit different. I think our priorities this year are a little more focused on on return to shareholders. We're going to be a little more aggressive on the share buybacks. As we said in our prepared remarks, $500 million to $650 million and buybacks at a minimum for this year, but we'll also look for some business development things which can be creative and help build our revenue and EBITDA streams.

在任何一年，我們的優先事項可能會有點不同。我認為我們今年的重點是股東回報。我們將更積極地進行股票回購。正如我們在準備好的發言中所說的那樣，今年的回購金額至少為 5 億至 6.5 億美元，但我們也會尋找一些富有創意的業務發展機會，幫助增加我們的收入和 EBITDA 流量。

And to Scott's point, the $1 billion of capital we've announced. Even with that number, we are maintaining strategic flexibility going forward to evaluate all options for capital that includes additional share buybacks, that includes accretive business development and the ability to continue to delever if we deem if we'd like.

正如斯科特所說，我們已經宣布了 10 億美元的資本。即使有這個數字，我們仍然會保持策略靈活性，以評估所有的資本選擇，包括額外的股票回購、增值業務發展以及在我們認為願意的情況下繼續去槓桿的能力。

And this is Philippe with regard to Selatogrel and Cenerimod. Yeah, the data is expected late 2026 for both programs. As I mentioned, enrollment is going very well for both programs, so it could be a bit earlier than that, if the trends continue. But right now, we're keeping that that late 2026 timing for the data.

這是 Philippe 關於 Selatogrel 和 Cenerimod 的評論。是的，這兩個項目的數據預計都在 2026 年底出來。正如我所提到的，這兩個項目的報名情況都很好，所以如果這種趨勢繼續下去，這個時間可能會更早。但目前，我們將資料保留到 2026 年末。

Ash Verma, UBS.

瑞銀的 Ash Verma。

So I wanted to understand the implications for 2026. So typically, these type of warning letters can take a minimum of 2 years to resolve. I know you said that (inaudible) was already going to go off, but did you have some offsets planned for it already? And then secondly, just with today's update, I mean right now, the stock is trading 12% to 15%, down in pre-market. Why not be more aggressive on the buyback beyond what you've guided here?

所以我想了解這對 2026 年的影響。通常情況下，這類警告信至少需要兩年才能解決。我知道您說過（聽不清楚）即將發生，但是您是否已經為它制定了一些補償計劃？其次，根據今天的更新，我的意思是現在，該股盤前交易價格下跌了 12％ 至 15％。為什麼不採取比你在此處指導的更積極的回購措施？

So the remediation efforts in Indore are, I would say, more than halfway done. We expect to be done as we get to the late spring, early summer with the radiation at that point, we'll ask the FDA to come in and reinspect the facility. We -- relative to Lenalidomide, we talked extensively with the FDA and thought we had a really good case to get it on the exempt list because of the critical nature of that particular medicine. We were unable to do so. We looked for alternate sources of Lenalidomide and continued to do so.

所以我想說，印多爾的補救工作已經完成一半以上。我們預計，到了春末夏初，輻射處理工作將會完成，屆時，我們將請 FDA 來重新檢查該設施。關於來那度胺，我們與 FDA 進行了廣泛的交流，我們認為我們有充分的理由將其列入豁免名單，因為該特定藥物具有關鍵性。我們無法做到這一點。我們尋找來那度胺的替代來源並繼續這樣做。

However, Lenalidomide is scheduled to hit a secondary patent cliff, I'll say, or expected to the economics of it, expected to significantly diminish as we get into January of '26. So from a Lenalidomide perspective, this just brought that event up earlier for us 10 to 12 months earlier. I certainly would have liked to have that capital to deploy and as part of our revenue in EBITDA, but it was an event that was going to happen within within 10 to 12 months. We are looking high and low for alternate ways to be able to fill that. At this point, we don't have any.

然而，我想說，來那度胺即將遭遇第二次專利懸崖，或者從經濟角度來看，預計到26年1月，專利懸崖將大幅減少。因此從來那度胺的角度來看，這只是讓我們將該事件提前了 10 到 12 個月。我當然希望擁有這些資本並將其作為 EBITDA 收入的一部分，但這將是 10 到 12 個月內發生的事情。我們正在四處尋找其他方法來填補這一空缺。目前，我們還沒有。

So with today's update right now, the stock is trading sort of mid-teens down in pre-market, why not be even more aggressive on the buyback here beyond what you've guided.

因此，根據今天的更新，該股在盤前交易中下跌了 15% 左右，為什麼不在超出你所指導的範圍的情況下更積極地進行回購呢？

I think what we're trying to say here, our sector leading cash flows give us tremendous flexibility to do a number of different things. We are planning right now to give back between $1 billion and $1.2 billion to shareholders through dividend and for share buybacks. We definitely will evaluate where the share price is and is there an opportunity to be even more aggressive than that? I think we look at that $500 million to $650 million as a minimum for this year, but we will balance that as and we'll balance that share buyback relative to some business development opportunities, regional and creative deals that can help us build some more revenue in EBITDA. But certainly, in consideration will be increasing that the share buyback program if the stock remains under pressure.

我想我們在這裡想說的是，我們領先業界的現金流為我們提供了極大的靈活性，可以做很多不同的事情。我們目前計劃透過股利和股票回購的方式向股東返還 10 億至 12 億美元。我們肯定會評估股價的水平，以及是否有機會採取更積極的行動？我認為我們將今年的最低要求定為 5 億至 6.5 億美元，但我們會平衡這一目標，並將股票回購與一些業務發展機會、區域和創意交易進行平衡，這些交易可以幫助我們在 EBITDA 中創造更多收入。但可以肯定的是，如果股價繼續承壓，將考慮增加股票回購計畫。

Chris Schott, JP Morgan.

摩根大通的克里斯·肖特 (Chris Schott)。

Maybe first, can you just elaborate on the scope, the size and timing of the enterprise review you mentioned on the call? I'm just wondering is this something that's part of just ongoing efficiency efforts or something more substantial potentially?

首先，您能否詳細說明您在電話中提到的企業審查的範圍、規模和時間？我只是想知道，這是否是正在進行的效率努力的一部分，還是可能具有更重要的意義？

And then my second question was on Indore and gross margins, can you just walk through a little bit when we think about the year-over-year step down in gross margins, how much of that's coming from Indore and how much of that's coming from some of the factors that you cited?

我的第二個問題是關於印多爾和毛利率的，您能否稍微介紹一下，當我們想到毛利率同比下降時，其中有多少來自印多爾，又有多少來自您提到的一些因素？

This cost initiative was something that we had in our heads for a little while. If you think about the cadence of the pattern of the company 4 years ago, there was a merger of two large global companies. And then since then, we have divested 4 major businesses in terms of biosimilars, women's healthcare, OTC, API business, and given all that, I think it's really good timing.

我們考慮這個成本措施已經有一段時間了。如果你思考一下四年前公司的模式節奏，當時有兩家大型跨國公司進行了合併。從那時起，我們已經剝離了生物相似藥、女性保健、OTC、API業務等四大主要業務，考慮到這一切，我認為這確實是一個好時機。

And then with the Indore situation coming this year, I think it's a really good time for us to take a look at the enterprise. Do we have the right cost structure? Do we have the right people in the right places and not only from a cost efficiency standpoint, but also are we fit for purpose for being able to deliver our goals in '25, '26, and beyond. So I think it's a perfect moment for us to really take a look at our structure, how we're organized, where where our resources are allocated and make sure that we are organized best for today and for the future.

隨著今年印多爾局勢的出現，我認為這對我們來說是一個審視企業的好時機。我們的成本結構是否正確？我們是否將合適的人才放在合適的位置，不僅從成本效益的角度來看，而且我們是否適合在25年、26年及以後實現我們的目標。所以我認為現在是我們真正審視我們的結構、組織方式、資源分配方式的絕佳時機，並確保我們為當前和未來做好最佳組織。

And to your question, Chris, around gross margin, there were a couple of components as I mentioned, that were factoring into the step down. The largest component is Indore just given the high margin nature of both the penalties as well as Lenalidomide, the margin impact of Indore is about kind of close to 80%. margin. And then, in addition to that, we just have normal kind of based business price erosion and increase in some product supply costs and that has been offset with kind of benefits from just ongoing segment mix in our business.

克里斯，關於你的問題，關於毛利率，正如我所提到的，有幾個因素導致了毛利率的下降。最大的組成部分是印多爾，由於罰款和來那度胺的高利潤性質，印多爾的利潤影響接近 80%。利潤。除此之外，我們的業務價格也出現了正常的下滑，部分產品供應成本也出現了上漲，但這點被我們業務中持續進行的細分組合帶來的好處所抵消。

And just to follow up on your first question, I think I missed the part around around timing, and we have already initiated discussions internally around this. We're bringing some external people in to help with this. This will be an exercise that really will be focused on the first half of this year. I think the the effect of the positive effect from a cost benefit perspective will most likely be more fully realized in '26, but it's something that we have already initiated.

為了跟進你的第一個問題，我想我錯過了有關時間安排的部分，我們已經就此展開了內部討論。我們正在引入一些外部人員來幫助解決這個問題。這將是一次真正集中在今年上半年的演習。我認為從成本效益角度來看，其正面效應很可能會在26年得到更充分的實現，但這是我們已經開始做的事情。

Jason Gerberry, Bank of America.

美國銀行的傑森·格貝利（Jason Gerberry）。

So just for me, maybe I missed this, but why does the Indore facility issues have an impact on revenues outside the United States? And then my second question, just thinking about your generic pipeline assumptions for 2025, what are you thinking in terms of a, I know this isn't like a new product issue, but like, is generic Symbicort a headwind in 2025 due to competition? And how would you frame maybe the risk profile and aggregate of the pipeline contribution this year versus last year's pipeline contribution?

所以就我而言，也許我錯過了這一點，但為什麼印多爾工廠的問題會對美國以外的收入產生影響呢？然後我的第二個問題是，只是考慮一下您對 2025 年通用管道的假設，您在考慮什麼，我知道這不像是一個新產品問題，但是，由於競爭，通用 Symbicort 是否會在 2025 年面臨逆風？您如何建立今年與去年的管道貢獻的風險狀況和總量？

So just on the first question, I think when you get a situation like Indore and a warning letter and an active remediation that's ongoing right now, that active remediation sometimes can cause you to have a pause in manufacturing supply issues in certain cases. Even though the product can go into Europe, there might be shortages of certain products as we work through that plan and remediate.

因此，就第一個問題而言，我認為當你遇到像印多爾這樣的情況以及一封警告信和目前正在進行的積極補救措施時，這種積極補救措施有時可能會導致你在某些情況下暫停製造供應問題。即使產品可以進入歐洲，但在我們實施計劃和補救措施的過程中，某些產品可能會出現短缺。

We look for alternate sources of products while we're doing the remediation so you can see some some shortages with some products, but certainly not across the board and it's very specific to product and location, but it has to do with the remediation of the facility. And again, we've got a network of of facilities here from a manufacturing perspective, '26 globally, and we look for alternate sources when we have a shutdown for remediation or a slowdown for remediation like we do at Indore.

我們在進行補救的同時，也在尋找替代的產品來源，因此您可能會看到某些產品存在短缺，但肯定不是全面的，而且這與產品和位置非常相關，但這與設施的補救有關。再說一次，從製造角度來看，我們在這裡擁有一個設施網絡，全球有 26 個，當我們因補救而關閉或因補救而放緩時，我們會尋找替代來源，就像我們在印多爾所做的那樣。

Why don't I cover to your question around new product revenue, Chris, kind of our confidence in the $450 million to $550 million. We do think this is a de-risk number. We're confident in our range. Our history shows that we have consistently delivered or even exceeded our range.

克里斯，我為什麼不回答你關於新產品收入的問題呢？我們對 4.5 億到 5.5 億美元的信心是很大的。我們確實認為這是一個去風險的數字。我們對我們的產品範圍很有信心。我們的歷史表明我們始終如一地實現甚至超出了我們的範圍。

Just to give you a flavor of a little bit of the components, about 20% of that new product range we estimate is from already approved products. And in addition to that, we have several complex products, one of which Glucagon was already approved and is in the process of being launched. So obviously, this is a diverse portfolio there's pushes and takes, but we have confidence in that range.

只是為了讓您稍微了解一下這些成分，我們估計新產品系列中約有 20% 來自已核准的產品。除此之外，我們還有幾種複雜的產品，其中一種胰高血糖素已經獲得批准，正在上市中。因此顯然，這是一個多元化的投資組合，有推動也有索取，但我們對這個範圍有信心。

And on your question specifically -- this is Corinne. On your question specifically on on generic [symbicort]. So Breyna, I want to mention that we are very pleased with the performance of Breyna. And we continue to believe that Breyna will be a key contributor to our revenues and to our complex genes portfolio in 2025. So, this is our our assumption going forward.

具體來說，關於您的問題，我是科琳 (Corinne)。關於你的問題，特別是關於通用的[信必可]。所以布雷娜，我想說的是，我們對布雷娜的表現非常滿意。我們仍然相信，Breyna 將成為我們 2025 年收入和複雜基因組合的主要貢獻者。所以，這是我們未來的假設。

(Operator Instructions)

（操作員指令）

Umer Raffat, Evercore.

烏默·拉法特（Umer Raffat），Evercore。

First, Scott, Doretta, for you. At the conference in January, you guys talked about for the Indore warning letter, you guys mentioned it's 11 products and 4 of the 11 were exempt and more could get exempt, so most folks listening in just assuming what, hundreds of products in this company, 11 of them, so probably not so much. But the type of EBITDA hit we learned about today, considering also that you knew generic (inaudible) was one of them, I'm just curious about the thought process around how you guys communicated that to investors previously.

首先，史考特 (Scott)，多蕾塔 (Doretta)，請你們發言。在一月份的會議上，你們談到了印多爾警告信，你們提到它有 11 種產品，其中 4 種獲得豁免，更多的產品可能會獲得豁免，所以大多數聽眾只是假設這家公司有數百種產品，只有 11 種，所以可能並非如此。但我們今天了解到的 EBITDA 打擊類型，考慮到你們也知道通用（聽不清楚）是其中之一，我只是好奇你們之前如何向投資者傳達這一訊息的想法。

And secondly, on the Idorsia deal, I'm just curious what's the new information you've learned perhaps on a blinded basis for the ongoing trials which drove the decision to put in another $100 million which was technically what Idorsia was going to contribute to the R&D. And I acknowledge they couldn't get their licensing deal done, but just curious about your thought process as well.

其次，關於 Idorsia 交易，我很好奇您在進行中的盲法試驗中獲得了什麼新信息，從而決定再投入 1 億美元，從技術上講，這筆錢就是 Idorsia 將用於研發的金額。我承認他們無法完成許可協議，但我也很好奇您的想法。

Yeah, so relative to disclosure, JP Morgan, it was a very dynamic situation at that time. There were some products which were excluded, others in which we had an agreement from the FDA that we could go ahead and ask for exclusion and put our case together why. So, we were unsure exactly what that would look like. We were also exploring alternate forms of Lenalidomide from other companies to help fill that shortage gap So it was a very dynamic situation at that time.

是的，相對於披露，摩根大通當時的情況非常動態。有些產品被排除在外，而對於其他產品，我們與 FDA 達成了協議，我們可以繼續申請排除，並說明原因。因此，我們不確定它到底是什麼樣子。我們也正在探索其他公司的來那度胺替代形式，以幫助填補這一短缺空白，因此當時的情況非常活躍。

We didn't even have a good view on exact whether Lenalidomide would be excluded or not until just a few days ago. So, it's been very dynamic. We thought we had a great case because of the importance of the medication, it just did not materialize. And so, for me at JPMorgan to start to say, well, there's this product and not that product without being able to give the whole picture, I think gets to our credibility. What was really concerning to me was to be accurate, to be credible, to when I understood what exactly that list would look like and what exactly the impacts would look like that I could share that.

直到幾天前，我們甚至還沒有確切知道來那度胺是否會被排除在外。因此，它非常有活力。我們以為由於藥物的重要性，我們的案例很成功，但卻未能實現。因此，對於我摩根大通來說，如果不能提供全貌，就說有這個產品，沒有那個產品，我認為這會影響我們的信譽。我真正關心的是準確性和可信度，當我理解了該清單究竟是什麼樣子以及其影響究竟是什麼樣子時，我就可以與大家分享。

And I think it's only been in the last couple of days that it's been very clear to us what the US and non-US impacts are including Lenalidomide. I think the distortion that you see in terms of the magnitude from a revenue and EBITDA perspective is because specifically of Lenalidomide and the profit profile of that particular product.

我認為直到最近幾天我們才清楚地知道包括來那度胺在內的美國和美國以外地區的影響。我認為，從收入和 EBITDA 角度來看，幅度上的扭曲是由於來那度胺和該產品的利潤狀況造成的。

Idorsia, Philippe, do you want to just address what the status of those programs and what gives us confidence to continue to invest in them?

伊多西亞、菲利普，你們想談談這些計畫的現狀以及是什麼讓我們有信心繼續對它們進行投資嗎？

Yeah, so certainly, we like what we see. We have had significant interaction with the KOLs and and various PIs as well. The momentum of the studies is very high at this point in development. We've had multiple IDMCs or safety committees as well, safety committees and blinded to the data. And the feedback has been very positive to date, specifically to Selatogrel I think, as I've said previously and this is continuing.

是的，我們確實喜歡我們所看到的。我們也與 KOL 和各種 PI 進行了大量的互動。目前，研究的發展勢頭非常強勁。我們也有多個 IDMC 或安全委員會，這些安全委員會對資料視而不見。到目前為止，回饋都非常積極，特別是對於 Selatogrel 而言，正如我之前所說，而且這種回饋還在繼續。

What is particularly important is that we're seeing the patient self-injecting, self-injecting at the right time, which is within 30 minutes of the onset of symptoms, and then following up and taking themselves to the hospital for injection. So the study is really progressing as we would -- as intended and as designed originally. So we -- that gives us some level of confidence for the future.

特別重要的是，我們看到患者自我注射，在正確的時間自我注射，即在出現症狀後的 30 分鐘內，然後進行追蹤並去醫院注射。因此，研究確實在按照我們最初的意圖和設計進行。所以，這給了我們對未來某種程度的信心。

And if I can just add to that, I mean, it became apparent to us during the course of '24 that these were going to be very important programs. The feedback we were getting from sites and others was very positive, as Phillipe said, not that we obviously the data is blinded. We haven't seen any data that would direct us in a way, but just the way that everything was progressing, it felt to us like these programs are getting more important to us rather than less.

我可以補充一點，我的意思是，在 24 年期間我們意識到這些將是非常重要的項目。正如菲利普所說，我們從網站和其他人那裡得到的反饋非常積極，顯然這並不意味著我們的數據是盲目的。我們還沒有看到任何可以指導我們的數據，但一切進展順利，我們感覺這些專案對我們越來越重要，而不是越來越不重要。

And given what was going on with our partners, we thought the idea of making sure that we can enhance the data integrity, transfer these programs to our ownership even more quickly. I think it was important given the importance of these programs to our future revenue growth. And also at the same time being able to expand our geographic footprint, be able to get in Cenerimod into important markets for Asia where we've got very substantial infrastructure already and increase the long-term economics by reducing sales and regulatory milestones. It just seems to me like the right time to do it and a very beneficial situation for us at that nature.

考慮到我們合作夥伴的現狀，我們想到了確保能夠增強資料完整性並更快地將這些程式轉移給我們。我認為這很重要，因為這些項目對我們未來的收入成長非常重要。同時，我們也能夠擴大我們的地理覆蓋範圍，將 Cenerimod 帶入亞洲的重要市場，我們在這些市場已經擁有非常強大的基礎設施，並且可以透過降低銷售和監管里程碑來提高長期經濟效益。我認為現在是做這件事的最佳時機，而且對我們來說也非常有利。

For Cenerimod, just briefly, the rate of Interferon-1 high in Japan is extremely high. For SLE, it's very close to 100%. So having access to that population for Cenerimod specifically is quite important.

對於Cenerimod，簡單來說，日本的干擾素-1高發生率極高。對於 SLE，它非常接近 100%。因此，專門接觸該族群對於 Cenerimod 的使用來說非常重要。

Both from a research perspective and from a commercial perspective, yeah.

是的，無論從研究角度或商業角度都是如此。

Balaji Prasad, Barclays.

巴克萊銀行的巴拉吉‧普拉薩德 (Balaji Prasad)。

Firstly, curious about the investor day, you have your task clear for you in getting Indore clear, new complex generics launches on track, and some of the key pipeline events seem to be geared for late '25 or 2026. So what would the focus of the investor day be? Is it more of incremental updates or are you envisaging a strategic shift? That is one.

首先，對投資者日感到好奇，您的任務很明確，讓印多爾明確，新的複雜仿製藥發布步入正軌，一些關鍵的管道事件似乎準備在 2025 年末或 2026 年進行。那麼投資者日的重點是什麼？這更多的是增量更新還是您正在設想戰略轉變？那是一個。

Two, probably a minor follow up on Indore, it's reassuring to see that you're in control. Is there any commitment from the FDA on the timelines for reinspection in terms of service level from the time you tell them that you're ready for an inspection?

二，可能對印多爾進行了一次小規模的跟進，看到你掌控一切讓人感到安心。從您告訴 FDA 您已準備好接受檢查時起，FDA 是否對重新檢查的時間表以及服務等級做出任何承諾？

So that one first, it's difficult to predict the FDA during times of certainty and during times of uncertainty may be a little bit even more difficult. Our base plan calls for the remediation to be finished in the next couple of months for us to request over the summer, and hopefully, we can get a reinspection by the end of this year or early into 2026. That's our baseline timelines that we're looking at. Definitely contingent upon what happens within the federal government and I don't know if there's going to be changes to the cadence and flow and resources put behind those sorts of inspections, but that's the base case that we're going with.

首先，在確定性時期預測 FDA 很困難，在不確定時期預測可能會更加困難。我們的基本計劃是在接下來的幾個月內完成補救工作，以便我們在夏天提出要求，希望我們能在今年年底或 2026 年初重新進行檢查。這是我們正在關注的基準時間表。這肯定取決於聯邦政府內部的情況，我不知道這類檢查的節奏、流程和資源是否會發生變化，但這是我們的基本情況。

In terms of our investor event for later this year. I think there's 3 main things that we really like to focus on. What does our long-term revenue, EBITDA and EPS outlook look like? You know this is a year in '25, certainly an unexpected challenge in terms of what we have an Indore and moving up the loss of real economics and Lenalidomide, but it sets us up to be able to do the hard work this year to grow in '26 and beyond.

就我們今年稍後舉行的投資者活動而言。我認為我們真正要關注的是三件主要的事情。我們的長期收入、EBITDA 和 EPS 前景如何？您知道這是 25 年，對於我們擁有的印多爾以及不斷上升的實體經濟和來那度胺損失而言，這無疑是一個意想不到的挑戰，但它為我們今年能夠努力工作以在 26 年及以後實現增長奠定了基礎。

And so we want to be able to show that picture, talk about the revenue, EBITDA, EPS projection that we see over the next 5 years. We want to talk about the pipeline, both the innovative pipeline and what's happening, where are we progressing, what are the enrollment rates look like, the base business pipeline and what's in there and how that's coming, the complex generics. There's a lot of important things. I'd like to talk about a comprehensive GLP-1 strategy that we're going to execute and implement globally.

因此，我們希望能夠展示這幅圖景，討論未來 5 年的營收、EBITDA 和 EPS 預測。我們想要談論管道，包括創新管道和正在發生的事情、我們的進展、入學率是多少、基礎業務管道以及其中的內容和進展情況，還有複雜的通用產品。有很多重要的事情。我想談談我們將在全球範圍內執行和實施的全面 GLP-1 策略。

And finally, we'll be in a good position to really, in a few months to talk to you about this enterprise wide cost initiative that we are entering into and what we see the benefits of that and not final numbers likely, but certainly we can give a very good progress update on where we are with that.

最後，幾個月後，我們將能夠真正與大家討論我們正在實施的這項企業範圍的成本計劃，以及我們看到的這項計劃帶來的好處，雖然可能不會公佈最終的數字，但我們肯定可以就目前的進展情況提供一個很好的更新。

And just to clarify a point, all the Phase III readouts for this year will occur in the first half of this year, so we should be able to share most of that data with you during the investor day.

需要澄清的是，今年所有第三階段的數據都將在今年上半年公佈，因此我們應該能夠在投資者日期間與您分享大部分數據。

Ladies and gentlemen, with that, we'll be concluding today's question-and-answer session. I'd like to turn the floor back over to Scott Smith, CEO, for closing remarks.

女士們、先生們，今天的問答環節就到此結束。我想將發言權交還給執行長斯科特史密斯 (Scott Smith)，請他作最後發言。

Thank you very much and thank you for everybody on the call. Obviously, a little bit of a difficult situation, one that we take very seriously. We have our arms around the situation of Indore, significant impact here on '25. But you know the base business is strong, as I mentioned earlier, we would have 3% growth in top line, 2% growth EBITDA if it wasn't for the Indore situation. Again, we take it seriously, we're working hard on it, but I'm very excited about the future.

非常感謝，也感謝電話中的每個人。顯然，這是一個有點困難的情況，我們對此非常重視。我們密切關注印多爾的局勢，這對 25 年產生了重大影響。但您知道基礎業務很強勁，正如我之前提到的，如果不是印多爾的情況，我們的營業收入將成長 3%，EBITDA 將成長 2%。再說一次，我們非常重視這個問題，我們正在為此努力工作，但我對未來感到非常興奮。

As we head into '25, we're focused on driving strong commercial execution. We're advancing not only the base pipeline, but our innovative pipeline as well. We're prioritizing capital return '25 with a focus on share repurchases. We're executing our remediation plans for Indore, and we're beginning an enterprise-wide initiative to review our global infrastructure and identify even additional, even more additional cost savings. We are very committed to doing the hard work in '25 to drive sustainable growth in '26 and beyond. And look forward to talking about all this and more and giving an update on Indore and everything else as we get to our investor day a little bit later this year. So, thank you again for your attention.

當我們邁入25年時，我們專注於推動強大的商業執行。我們不僅在推進基礎管道，也在推動創新管道。我們優先考慮25年的資本回報，重點是股票回購。我們正在實施針對印多爾的補救計劃，並正在啟動一項全企業範圍的計劃來審查我們的全球基礎設施，並尋找甚至更多的額外成本節約。我們致力於在25年努力工作，以推動26年及以後的永續成長。我期待在今年稍後迎來投資者日之際討論所有這些以及更多內容，並提供有關印多爾和其他所有方面的最新消息。因此，再次感謝您的關注。

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.

女士們、先生們，今天的電話會議和演講就到此結束。我們非常感謝您的加入。現在您可以斷開線路了。