Viatris Inc (VTRS) 2025 Q3 法說會逐字稿

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  • William Szablewski - Head of Capital Markets

    William Szablewski - Head of Capital Markets

  • (audio in progress) -- '25 earnings call.

    (音訊正在播放)-2025 年財報電話會議。

  • With us today is our CEO, Scott Smith; CFO, Doretta Mistras, Chief R&D Officer, Philippe Martin; and Chief Commercial Officer, Corinne Le Goff.

    今天與我們在一起的有:執行長 Scott Smith;財務長 Doretta Mistras;首席研發長 Philippe Martin;以及首席商務官 Corinne Le Goff。

  • During today's call, we will 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,包括我們對 2025 年的財務預期和各項策略舉措。這些說法有風險和不確定性。我們也會提及一些實際的和預測的非GAAP財務指標。請參閱今天的幻燈片演示和我們向美國證券交易委員會提交的文件,以了解更多信息,包括這些非GAAP指標與最直接可比的GAAP指標的調節表。

  • When discussing 2025 actual or reported results, 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. When comparing our 2025 actual reported results to our expectations, we're making comparisons to our 2025 financial guidance.

    在討論 2025 年實際或已報告的業績時,我們將以剝離調整後的營運基礎與 2024 年實際或已報告的業績進行某些比較,這排除了外匯匯率的影響,也排除了 2024 年完成的剝離交易在 2024 年期間的相應業績。我們可以將這些稱為營運層面的變化。在將我們 2025 年實際公佈的業績與我們的預期進行比較時,我們將與我們的 2025 年財務指導進行比較。

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

    接下來,我將把電話交給我們的執行長史考特史密斯。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Good morning everyone. We delivered another strong quarter by focusing on our 2025 strategic priorities. Driving strong commercial execution, advancing our pipeline, returning capital to shareholders through dividends and share repurchases, pursuing end-market business development opportunities, and advancing our enterprise-wide strategic review to identify opportunities to deliver meaningful net cost savings; A portion of which we anticipate reinvesting in the business to fund future growth.

    大家早安。我們透過專注於2025年的策略重點,又取得了強勁的季度業績。推動強勁的商業執行,推進我們的產品線,透過股利和股票回購向股東返還資本,尋求終端市場業務發展機會,並推進我們全公司的策略審查,以尋找實現有意義的淨成本節約的機會;我們預計將其中一部分再投資於業務,以資助未來的成長。

  • Our fundamentals remain solid, giving us good momentum as we head into year-end, momentum we expect to carry into 2026. Before we dive into the details of the quarter, let me provide an update on our strategic review.

    我們的基本面依然穩固,這為我們進入年底提供了良好的發展勢頭,我們預計這種勢頭將延續到 2026 年。在深入探討本季細節之前,讓我先介紹一下我們的策略評估的最新情況。

  • For context, the work we've done over the past five years strengthening our balance sheet, divesting non-core assets, and investing in innovation has set the stage for the strategic review as a natural next step in our evolution. We've made significant progress since we announced the initiative in February. We continue to perform a detailed analysis of the totality of our business.

    作為背景,過去五年我們透過加強資產負債表、剝離非核心資產和投資創新所做的工作,為策略審查奠定了基礎,使其成為我們發展進程中的自然下一步。自從二月宣布這項計劃以來,我們已經取得了顯著進展。我們將繼續對公司整體業務進行詳細分析。

  • As part of our analysis to date, we've identified areas for including potential operating efficiencies including our commercial sales and marketing model and product mix, our R&D, medical and regulatory activities, our sourcing, manufacturing, and supply chain, including inventory optimization, and how our corporate functions provide support.

    作為我們迄今為止分析的一部分,我們已經確定了一些可以提高營運效率的領域,包括我們的商業銷售和行銷模式和產品組合、我們的研發、醫療和監管活動、我們的採購、製造和供應鏈(包括庫存優化)以及我們的公司職能部門如何提供支援。

  • Looking to the future, we envision a company that delivers sustained profitable growth by focusing on three key areas: a global generics business that will continue to evolve towards more profitable higher-margin complex products, an established brands business that will be strengthened by continuing to add brands that leverage our global capabilities, and an innovative brands business that will be expanded by building a portfolio of late-stage or new-market growth assets sourced both internally and externally.

    展望未來,我們設想公司將專注於三個關鍵領域,從而實現持續盈利增長:全球仿製藥業務將繼續發展,朝著利潤更高、利潤更豐厚的複雜產品方向發展;成熟品牌業務將通過不斷增加利用我們全球能力的品牌而得到加強;創新品牌業務將通過構建內部和外部來源的後期或新市場增長資產組合而得到擴展。

  • We anticipate being able to deliver meaningful net cost savings over a multiyear period, while also being able to reinvest a portion of the savings back into the business to fund future growth opportunities. We look forward to sharing more details, including quantification of the net cost savings and reinvestment opportunities at our planned investor event in 2026.

    我們預計能夠在多年內實現顯著的淨成本節約,同時也能將部分節省下來的資金再投資到業務中,以資助未來的成長機會。我們期待在 2026 年計畫舉辦的投資者活動上分享更多細節,包括淨成本節約和再投資機會的量化數據。

  • Now let me share a few highlights from the quarter. This quarter's commercial performance was strong across our portfolio, particularly in Europe, emerging markets, and the Greater China region. We delivered 1% operational revenue growth excluding indoor, in line with our expectations, reflecting continued execution across our businesses.

    現在讓我來分享本季的一些亮點。本季我們所有產品組合的商業表現都很強勁,尤其是在歐洲、新興市場和大中華區。不計室內業務,我們的營運收入成長了 1%,符合預期,這反映了我們各項業務的持續有效執行。

  • Primarily driven by the benefit from foreign exchange and supported by our strong operational performance, we are raising our full-year guidance range across certain key financial metrics, including total revenues, adjusted EBITDA, and adjusted EPS. At our Indore facility, our initial remediation activities are substantially complete.

    主要得益於外匯收益和強勁的營運業績,我們將提高全年業績預期範圍,涵蓋某些關鍵財務指標,包括總收入、調整後 EBITDA 和調整後每股收益。我們在印多爾的工廠,初步修復工作已基本完成。

  • We recently met with the FDA to review progress and discuss potential timing for reinspection. While timing remains at the discretion of the agency, we have built and continue to build operational redundancies by requalifying other sites and adding third-party vendors for products originally manufactured at Indore.

    我們最近與美國食品藥物管理局 (FDA) 會面,審查進度並討論重新檢查的潛在時間。雖然時間安排仍由該機構自行決定,但我們已經建立並將繼續建立營運冗餘,透過重新認證其他站點並為最初在印多爾生產的產品增加第三方供應商來實現。

  • Importantly, we continue to make progress on advancing our pipeline. Here are some of the highlights. We are excited about our fast-acting Meloxicam. The acute pain market in the US is significant, and we believe we can offer a differentiated alternative for patients seeking non-opioid pain relief. We expect to submit our NDA by the end of the year and are already working on our go-to-market strategy.

    重要的是,我們在推進產品線建設方面持續取得進展。以下是一些亮點。我們對速效美洛昔康感到非常興奮。美國急性疼痛市場規模龐大,我們相信能夠為尋求非鴉片類鎮痛藥物的患者提供差異化的替代方案。我們預計在年底前提交保密協議,並且已經在製定市場推廣策略。

  • Our low-dose estrogen weekly patch is now under FDA review following the filing of our NDA late in Q3, with a decision expected in mid-2026 and a launch soon thereafter. For sotagliflozin, we've already made filings in multiple markets around the world and expect to file in more countries by the end of the year. For selatogrel and cenerimod, Phase 3 enrollment for both programs is progressing well.

    我們低劑量雌激素每週貼片已於第三季末提交了新藥申請,目前正在接受 FDA 的審查,預計將於 2026 年年中做出決定,之後不久即可上市。對於索格列淨,我們已經在全球多個市場提交了申請,並預計到今年年底將在更多國家提交申請。selatogrel 和 cenerimod 的 3 期臨床試驗招募工作進展順利。

  • In addition, we've initiated a Phase 3 program investigating cenerimod for the treatment of lupus nephritis, with enrollment of our first patient anticipated by the end of the year. We continue to view both selatogrel and cenerimod as transformational treatments with blockbuster potential and are beginning to plan for commercialization.

    此外,我們已啟動一項 3 期臨床試驗項目,研究 cenerimod 治療狼瘡性腎炎的療效,預計在年底前招募首例患者。我們仍然認為 selatogrel 和 cenerimod 都是具有突破性潛力的變革性療法,並開始計劃將其商業化。

  • We are excited about our recent acquisition of Aculys Pharma in Japan, adding two innovative CNS assets, pitolisant and Spydia, to our portfolio. This strengthens our presence in Japan, a strategically important market for us, and leverages our CNS infrastructure and expertise.

    我們很高興最近收購了日本的 Aculys Pharma 公司,將兩項創新的中樞神經系統資產 pitolisant 和 Spydia 加入我們的產品組合。這將加強我們在日本(對我們來說具有重要戰略意義的市場)的地位,並充分利用我們的中樞神經系統基礎設施和專業知識。

  • Business development and M&A remain key strategic levers to accelerate growth, enhance shareholder value, and create meaningful impact for patients. Through regional business development, we continue to pursue opportunities to strengthen our generics and established brands portfolios while building our presence in innovative brands that can benefit from our global scale, capabilities, and infrastructure.

    業務發展和併購仍然是加速成長、提升股東價值和為患者創造有意義影響的關鍵策略槓桿。透過區域業務發展,我們不斷尋求機會,加強我們的仿製藥和成熟品牌組合,同時在能夠受益於我們全球規模、能力和基礎設施的創新品牌領域建立我們的影響力。

  • In parallel, we are evaluating targeted strategic M&A opportunities, particularly in the US, focused on commercial stage accretive transactions designed to expand our business and further enhance the company's long-term growth profile.

    同時,我們正在評估有針對性的策略併購機會,尤其是在美國,重點是旨在擴大業務並進一步提升公司長期成長前景的商業階段增值交易。

  • We're balancing investment and growth with the return of capital to shareholders through dividends and share repurchases. Year to date, we've returned more than $920 million to shareholders, including $500 million in share repurchases. This puts us firmly on track to return over $1 billion in capital for the year.

    我們力求在投資和成長之間取得平衡,同時透過股利和股票回購向股東返還資本。今年迄今為止,我們已向股東返還超過 9.2 億美元,其中包括 5 億美元的股票回購。這將使我們穩步朝著今年實現超過10億美元資本回報的目標邁進。

  • Overall, we're very encouraged by the progress we're making; taking bold actions that are intended to strengthen our foundation, expand our capabilities, and position Viatris for long-term profitable growth. We believe we're building a company that's more agile, more innovative, and better aligned with the opportunities for tomorrow.

    總的來說,我們對目前的進展感到非常鼓舞;我們採取大膽的行動,旨在加強我們的基礎,擴大我們的能力,並使 Viatris 實現長期盈利增長。我們相信,我們正在打造一家更靈活、更具創新性、更能掌握未來機會的公司。

  • Now, I'll turn it over to Philippe Martin.

    現在,我將把麥克風交給菲利普馬丁。

  • Philippe Martin - Chief R&D Officer

    Philippe Martin - Chief R&D Officer

  • Thank you, Scott. We've had another strong quarter progressing our entire R&D pipeline globally and securing product approval in key markets worldwide. Our late-stage programs are advancing at a very strong pace, beginning with our fast-acting Meloxicam.

    謝謝你,斯科特。我們又迎來了一個強勁的季度,在全球範圍內推進了所有研發項目,並在全球主要市場獲得了產品批准。我們的後期研發專案進展非常迅速,首先是我們的速效藥物美洛昔康。

  • Over the past two months, we've participated in the American Society of Anesthesiology and the Pain Week medical conferences, generating strong enthusiasm among the pain healthcare community on our Phase 3 data. Several important data points from our presentations and KOL discussion underscore the product's distinct clinical profile.

    在過去的兩個月裡,我們參加了美國麻醉學會和疼痛週醫學會議,我們的 3 期數據在疼痛醫療保健界引起了極大的熱情。我們在演示和 KOL 討論中提出的幾個重要數據點突顯了該產品獨特的臨床特徵。

  • First, its pharmacokinetic profile and the speed of onset. This is demonstrated by faster Tmax and higher Cmax compared with Mobic. Specifically, fast-acting meloxicam achieved the Tmax of approximately 45 minutes versus approximately four hours for Mobic.

    首先,它的藥物動力學特性和起效速度。與莫比可相比,Tmax 更快,Cmax 更高,證明了這一點。具體來說,速效美洛昔康的 Tmax 約為 45 分鐘,而莫比可的 Tmax 約為 4 小時。

  • Second, its strong and sustained analgesic efficacy with statistically significant pain relief over 48 hours versus placebo, confirming durable pain control in both soft tissue and bony surgical models. In post hoc analysis, fast-acting meloxicam showed greater overall pain relief over 48 hours and faster pain relief than its opioid competitor, tramadol, across both surgical models.

    其次,與安慰劑相比,該藥物具有強效且持久的鎮痛效果,在 48 小時內疼痛緩解具有統計學意義,證實了其在軟組織和骨科手術模型中均能持久控制疼痛。事後分析顯示,在兩種手術模型中,速效美洛昔康在 48 小時內整體鎮痛效果更佳,鎮痛速度也比其阿片類藥物競爭對手曲馬多更快。

  • And third, its opioid-sparing effect as demonstrated by a significant reduction in opioid use and a significantly higher number of opioid-free patients compared to placebo, indicating significantly reduced reliance on opioids for pain management.

    第三,與安慰劑相比,該藥物顯著減少了阿片類藥物的使用,並且無阿片類藥物患者的數量顯著增加,這表明該藥物具有減少阿片類藥物使用的效果,從而顯著降低了對阿片類藥物的依賴性,用於疼痛管理。

  • Our goal, subject to FDA agreement, is to include a reduction in opioid use as part of the product label. We anticipate submitting an NDA by year-end through the 505(b)(2) pathway, barring any unforeseen delays related to the US government shutdown. Turning to MR-141 in Presbyopia, we plan to submit an sNDA by year-end. MR142-in dim light disturbances. The second Phase III study is well on its way, with full recruitment and top-line results expected in 2026.

    我們的目標是(在獲得 FDA 同意的前提下)將減少阿片類藥物的使用納入產品標籤。我們預計在年底前透過 505(b)(2) 途徑提交一份 NDA,除非出現與美國政府停擺相關的任何不可預見的延誤。關於 MR-141 在老花眼治療中的應用,我們計劃在年底前提交補充新藥申請 (sNDA)。MR142-在弱光幹擾下。第二項 III 期研究進展順利,預計 2026 年完成全部招募並公佈初步結果。

  • Our NDA for our low-dose estrogen weekly patch for contraception was submitted in late Q3 ahead of the government shutdown. Approval is expected by mid-2026. In addition, our next-generation Norelgestromin only patch is currently in Phase 3 with results expected in 2027. We've also submitted additional regulatory applications in recent months for cetagliflocin in Canada, Australia, and New Zealand, with filings in Mexico and Malaysia expected by year-end.

    我們用於避孕的低劑量雌激素每週貼片的NDA申請已於第三季末提交,當時正值政府停擺之前。預計於2026年中期獲得批准。此外,我們的下一代諾孕酮單方貼片目前處於第 3 期臨床試驗階段,預計將於 2027 年公佈結果。最近幾個月,我們也向加拿大、澳洲和紐西蘭提交了西格列淨的額外監管申請,預計年底前將在墨西哥和馬來西亞提交申請。

  • Recent data presented at the ESC Congress further highlights sotagliflozin's early benefit in reducing heart failure-related outcomes when initiated before discharge following a hospitalization for heart failure.

    在 ESC 大會上公佈的最新數據進一步強調了索格列淨在降低心臟衰竭相關後果方面的早期益處,該藥物可在心臟衰竭住院治療後出院前開始使用。

  • Compared with selective SGLT2 inhibitor trials, the benefit observed with sotagliflozin in the SOLOIST study cohort distinctly differentiates sotagliflozin within the class, particularly when it comes to reducing cardiovascular death, worsening heart failure, and all-cause mortality. Consistent with its dual SGLT1 and SGLT2 inhibition, sotagliflozin is the first SGLT inhibitor to demonstrate a significant reduction in MI and stroke.

    與選擇性 SGLT2 抑制劑試驗相比,SOLOIST 研究隊列中觀察到的索格列淨的益處明顯區別於同類藥物,尤其是在降低心血管死亡、心臟衰竭惡化和全因死亡率方面。索格列淨具有雙重 SGLT1 和 SGLT2 抑製作用,是第一個被證實能顯著降低心肌梗塞和中風風險的 SGLT 抑制劑。

  • In Japan, we have several near-term opportunities as we continue to steadily and strategically build our innovative pipeline. Our JNDA for Effexor for general anxiety disorder currently under review by the PMDA is progressing well, with approval anticipated in the first half of 2026. The Japanese Phase 3 data supporting this submission was recently published in the Journal of Psychiatry and Clinical Neurosciences.

    在日本,隨著我們繼續穩步、有策略地建立創新產品線,我們近期將迎來幾個發展機會。我們用於治療廣泛性焦慮症的 Effexor 的日本新藥申請 (JNDA) 目前正在接受 PMDA 的審查,進展順利,預計將於 2026 年上半年獲得批准。支持本次提交的日本 3 期臨床試驗數據最近已發表在《精神病學與臨床神經科學雜誌》上。

  • The recent addition of pitolisant aligns with our strategy to acquire de-risked assets supported by positive Phase 3 data. Pitolisant, with its well-established profile, has made a meaningful impact for patients in the US and Europe. It is approved for treating excessive daytime sleepiness and cataplexy in adult patients with narcolepsy in the US and Europe. Additionally, it is approved for excessive daytime sleepiness associated with obstructive sleep apnea in Europe.

    最近收購匹托利桑符合我們收購有積極 3 期數據支持的低風險資產的策略。匹托利桑憑藉其良好的療效,已對美國和歐洲的患者產生了顯著的影響。該藥已獲准在美國和歐洲用於治療成人嗜睡症患者的白天過度嗜睡和猝倒症狀。此外,它還被歐洲批准用於治療與阻塞性睡眠呼吸中止症相關的白天過度嗜睡。

  • We remain on track to submit two JNDAs for OSAAS and narcolepsy during Q4 this year. Our Phase 3 trial of Nefecon for the treatment of IgA nephropathy is fully enrolled, with results expected early next year.

    我們仍按計畫在今年第四季提交兩項針對阻塞性睡眠呼吸中止症和發作性睡病的新藥申請。我們針對 IgA 腎病治療的 Nefecon 的 3 期試驗已全部招募完畢,預計明年初將公佈結果。

  • IgA nephropathy represents a significant unmet medical need in Japan with limited treatment options available. Our Phase 2 trials of Tyrvaya for dry eye disease in Japanese patients were consistent with the global Phase 3 results. We expect to initiate the Phase 2 trial in Japan in the very near future.

    IgA腎病在日本是亟待解決的重大醫療問題,可用的治療方案有限。我們針對日本患者進行的 Tyrvaya 治療乾眼症的 2 期試驗結果與全球 3 期試驗結果一致。我們預計在不久的將來在日本啟動二期臨床試驗。

  • Turning to our complex generics pipeline, we continue to secure approval for many of our generic products globally. We expect to receive FDA approval soon for a period of time. This will mark our fourth injectable FDA approval this year, joining iron sucrose, paclitaxel, and liposomal amphotericin B, underscoring our strategy to expand the generics portfolio with technically complex high-value products.

    就我們複雜的仿製藥產品線而言,我們繼續在全球範圍內獲得許多仿製藥產品的批准。我們預計很快就能獲得FDA的批准,有效期限為一段時間。這將是我們今年獲得 FDA 批准的第四種注射劑,此前已批准了蔗糖鐵、紫杉醇和脂質體兩性黴素 B,這凸顯了我們透過技術複雜、高價值的產品來擴大仿製藥產品組合的策略。

  • And finally, let's cover the progress we've made with selatogrel and cenerimod. Selatogrel enrollment continues to accelerate, now approaching 1,000 patients per month, keeping us on track to complete enrollment next year. At the recent ICC Great Wall of China and ESC congresses, KOLs emphasized the risk associated with patient delay in symptom recognition and the need for early intervention, reinforcing the potential of selatogrel's novel approach in providing early, rapid, self-administered treatment for suspected MI.

    最後,讓我們回顧一下我們在 selatogrel 和 cenerimod 方面取得的進展。Selatogrel 的入組人數持續加快,目前每月接近 1000 名患者,這使我們能夠按計劃在明年完成入組。在最近舉行的 ICC 長城中國大會和 ESC 大會上,KOL 強調了患者延遲識別症狀的風險以及早期幹預的必要性,強化了 selatogrel 的新方法在為疑似 MI 患者提供早期、快速、自我給藥治療方面的潛力。

  • For cenerimod in SLE, patient enrollment in OPUS two will close this month, followed shortly by OPUS one. We anticipate our Phase 3 readout around year-end 2026. Recent insights from KOL interaction at ACR highlighted the importance of the S1P axis in the pathogenesis of SLE and continue to validate cenerimod's differentiated mechanism of action, which acts on B and T cells, as well as antigen-presenting cells, and dampens both innate and adaptive immunity.

    對於 cenerimod 治療 SLE,OPUS 2 的患者招募將於本月結束,隨後 OPUS 1 也將很快結束。我們預計 3 期臨床試驗結果將於 2026 年底左右公佈。ACR 上 KOL 互動的最新見解強調了 S1P 軸在 SLE 發病機制中的重要性,並繼續驗證了 cenerimod 的差異化作用機制,該機製作用於 B 細胞和 T 細胞以及抗原呈現細胞,並抑制先天性和適應性免疫。

  • In addition, cenerimod's mechanism of action is also highly relevant to lupus nephritis. We therefore initiated a Phase 3 program in this indication. Our first patient enrolled is anticipated by year-end, with full enrollment expected around 2027. The Phase 3 study is the most inclusive lupus nephritis study so far, inclusive of patients with active histological lupus nephritis Class III, IV, and V, with eGFR down to 15 milliliters per minute and with a broad background therapy with or without antimalarial or Benlysta.

    此外,cenerimod 的作用機轉也與狼瘡性腎炎密切相關。因此,我們針對此適應症啟動了3期臨床試驗計畫。預計到年底我們將招募到第一位患者,全面招募工作預計將在 2027 年左右完成。這項 3 期研究是迄今為止最全面的狼瘡性腎炎研究,納入了組織學分級為 III、IV 和 V 的活動性狼瘡性腎炎患者,其 eGFR 低至每分鐘 15 毫升,並接受了廣泛的背景治療,無論是否使用抗瘧藥或 Benlysta。

  • In closing, we've made significant strides advancing our pipeline. We are seeing the results of focused execution and scientific discipline, as well as meaningful scientific engagement across our entire R&D pipeline, from generics to established brands and innovative assets.

    最後,我們在推進產品線方面取得了重大進展。我們看到了專注執行、科學嚴謹以及在整個研發流程中進行有意義的科學合作所帶來的成果,從仿製藥到成熟品牌和創新資產,無一例外。

  • Now, I'll turn the call over to Corinne.

    現在,我把電話交給科琳。

  • Corinne Le Goff - Chief Commercial Officer

    Corinne Le Goff - Chief Commercial Officer

  • Thank you, Philippe. Our portfolio strategy is taking shape, fueled by the positive pipeline momentum we have seen this year. Today, I'll highlight a few of the more significant near-term commercial opportunities.

    謝謝你,菲利普。在今年我們看到的積極專案進展勢頭的推動下,我們的投資組合策略正在逐步成形。今天,我將重點介紹幾個比較重要的近期商業機會。

  • As we shared last quarter, we remain excited about our fast-acting meloxicam. The moderate to severe acute pain market is substantial, and there remains a clear unmet need for fast, sustained, and meaningful non-opioid pain relief. Let me share more on the broad market opportunity and how we're shaping our commercial strategy.

    正如我們上個季度所分享的,我們仍然對我們的速效美洛昔康感到興奮。中度至重度急性疼痛市場規模龐大,對快速、持久、有效的非鴉片類鎮痛方法仍有明顯的未滿足需求。讓我進一步分享一下廣闊的市場機會以及我們如何制定商業策略。

  • There are approximately 80 million acute pain cases per year in the US, and going forward, the incidence is expected to grow at a 2% CAGR due to an aging population and an increased number of surgeries and medical procedures.

    美國每年約有 8000 萬例急性疼痛病例,而且由於人口老化以及手術和醫療程序數量的增加,預計未來發病率將以 2% 的複合年增長率增長。

  • These patients are predominantly seen in outpatient and ambulatory surgical centers for procedures like gallbladder removal, joint replacements, hernia surgery, or bunionectomy, or in procedure-focused offices for prosthetic or dental surgeries.

    這些患者主要在門診和日間手術中心接受膽囊切除、關節置換、疝氣手術或拇外翻切除等手術,或在以手術為主的診所接受義肢或牙科手術。

  • Now switching to the evolution of the treatment landscape. Opioids currently account for roughly half of all acute pain prescriptions, despite the known risk of dependence and misuse. Tramadol remains one of the most prescribed opioids for acute pain. There is therefore a strong demand for safer alternatives combining strong efficacy with an established safety profile.

    現在轉到治療領域的演變。儘管已知阿片類藥物存在依賴性和濫用風險,但目前阿片類藥物約佔所有急性疼痛處方的一半。曲馬多仍然是治療急性疼痛最常用的鴉片類藥物之一。因此,市場對兼具高效性和良好安全性的更安全的替代品有著強烈的需求。

  • In fact, current treatment guidelines show a strong consensus to minimize opioid use and prioritize non-opioid multimodal pain management strategies that include acetaminophen and NSAIDs. NSAIDs make up a substantial proportion of the total acute pain prescription volume because of their low addiction risk, short-term tolerability, and anti-inflammatory effects.

    事實上,目前的治療指引已達成強烈共識,即盡量減少鴉片類藥物的使用,優先採用包括對乙醯氨基酚和非類固醇抗發炎藥在內的非鴉片類多模式疼痛管理策略。非類固醇抗發炎藥因其成癮風險低、短期耐受性好以及抗發炎作用,在急性疼痛處方總量中佔相當大的比例。

  • We believe fast-acting oral meloxicam is well-positioned as a differentiated option among currently available NSAIDs for moderate to severe acute pain. Since receiving the data in May, our teams have been working hard to further shape our go-to-market strategy. We are progressing well with launch planning, including branding, positioning, prescriber segmentation, channel strategy, and pricing and payer dynamics. We are taking a targeted approach to market segmentation, focusing on settings where fast, effective alternatives to opioids are most needed.

    我們認為,速效口服美洛昔康作為目前市面上用於治療中度至重度急性疼痛的非類固醇抗發炎藥,具有獨特的優勢。自從五月收到數據以來,我們的團隊一直在努力進一步完善我們的市場推廣策略。我們的上市計劃進展順利,包括品牌建立、定位、處方醫生細分、通路策略、定價和支付方動態。我們採取有針對性的市場區隔方法,重點關注最需要快速、有效的鴉片類藥物替代品的領域。

  • We plan to leverage our own specialty sales team and are exploring partnerships to expand reach across key prescriber segments, which will enable us to go to market more efficiently and cost-effectively. We anticipate being in a ready position to launch pending the FDA review cycle. We are also very focused on launch preparations for our low-dose estrogen contraceptive patch.

    我們計劃利用我們自己的專業銷售團隊,並正在探索合作夥伴關係,以擴大在主要處方醫生群體中的覆蓋範圍,這將使我們能夠更有效率、更經濟地進入市場。我們預計在等待FDA審查結果後即可做好上市準備。我們也正全力以赴地籌備低劑量雌激素避孕貼片的上市事宜。

  • This weekly patch fills an important need for women seeking a lower-dose estrogen option for contraception. It also offers advanced patch technology, as demonstrated by potential best-in-class patch adhesion performance observed in our Phase III study. We expect this product will be another meaningful contributor, and we are planning toward a launch in the US in the second half of 2026.

    這種每週一次的貼片滿足了尋求低劑量雌激素避孕方式的女性的重要需求。它還提供了先進的貼片技術,正如我們在 III 期研究中觀察到的潛在一流的貼片黏合性能所證明的那樣。我們預計該產品將做出另一項重要貢獻,並計劃於 2026 年下半年在美國推出。

  • Outside the US, we have made major strides in building out our innovative brand portfolio in Japan with the acquisition of Aculys. The addition of pitolisant and Spydia further expands our portfolio of innovative CNS products, which will be complemented by Effexor for generalized anxiety disorder. These innovative assets, plus the many others in our late-stage pipeline, combined with the strength of our generics and established brands portfolios, position us well to positively impact patients' lives and create value for the business.

    在美國以外,我們透過收購 Aculys 在日本建立了創新品牌組合,取得了重大進展。匹托利桑和 Spydia 的加入進一步擴展了我們創新的中樞神經系統產品組合,而 Effexor 將用於治療廣泛性焦慮症,從而完善我們的產品線。這些創新資產,加上我們後期研發管線中的許多其他資產,以及我們強大的仿製藥和成熟品牌組合,使我們能夠更好地改善患者的生活,並為企業創造價值。

  • Now I'll turn it over to Doretta.

    現在我把麥克風交給多蕾塔。

  • Doretta Mistras - Chief Financial Officer

    Doretta Mistras - Chief Financial Officer

  • Thank you, Corinne, and good morning, everyone. I am pleased to report that we had another strong quarter, underscoring the continued performance of our broad global portfolio of generics and brands. My remarks this morning will focus on key highlights of our strong financial performance, significant free cash flow generation, capital allocation activities year to date, and the outlook for the rest of this year.

    謝謝你,科琳,大家早安。我很高興地報告,我們又迎來了一個強勁的季度,這凸顯了我們廣泛的全球仿製藥和品牌藥組合的持續良好表現。我今天早上的演講將重點介紹我們強勁的財務業績、可觀的自由現金流、今年迄今為止的資本配置活動以及今年剩餘時間的展望。

  • Focusing on our third-quarter results, total revenues were $3.76 billion, which were down approximately 1% versus the prior year. Excluding the indoor impact, we delivered operational revenue growth of approximately 1% versus the prior year. In developed markets, net sales were down 5%, primarily driven by the indoor impact.

    聚焦第三季業績,總營收為 37.6 億美元,較上年同期下降約 1%。剔除室內業務的影響,我們的營運收入比上年增長了約 1%。在已開發市場,淨銷售額下降了 5%,主要原因是室內活動的影響。

  • Breaking the segment down further, in Europe, our business continues to deliver consistent and durable performance, growing approximately 1% this quarter. The generics business continues to perform solidly and was up 5% year over year. This was primarily driven by new product revenues in key markets such as France and Italy. And within our branded business, solid growth in EpiPen, Creon, and our thrombosis portfolio helped to partially absorb the anticipated competition on Dynista.

    進一步細分該業務板塊,在歐洲,我們的業務持續保持穩定持久的業績,本季成長約 1%。仿製藥業務持續保持穩健成長,較去年同期成長 5%。這主要得益於法國和義大利等重點市場的新產品收入。在我們的品牌業務中,EpiPen、Creon 和我們的血栓產品組合的穩健成長,有助於部分抵消 Dynista 預期的競爭。

  • As anticipated, our North America business decreased 12% versus the prior year, primarily as a result of the indoor impact and competition on certain generic products.

    正如預期的那樣,我們的北美業務比前一年下降了 12%,主要原因是室內活動的影響以及某些仿製藥的競爭。

  • However, we continue to see double-digit growth in certain products such as BRANA and YUPELRI, as well as benefits from new product revenues, such as iron sucrose. In emerging markets, net sales increased approximately 7% versus the prior year. This was primarily driven by continued strength in our established brands across key markets, including Turkey, Mexico, and Emerging Asia.

    然而,我們繼續看到某些產品(如 BRANA 和 YUPELRI)達到兩位數成長,以及鐵蔗糖等新產品收入帶來的收益。在新興市場,淨銷售額比上年增長約 7%。這主要得益於我們在土耳其、墨西哥和新興亞洲等主要市場中成熟品牌的持續強勁表現。

  • And the growth in our generics business was primarily driven by stabilization of supply for certain lower-margin ARB products. In Japan, net sales decreased approximately 9%. Results were primarily driven by expected impacts from government price regulations, as well as a change in reimbursement that impacted off-patent brands in Japan. We also saw competition on certain products in Australia.

    我們仿製藥業務的成長主要得益於某些低利潤 ARB 產品的供應穩定。在日本,淨銷售額下降了約 9%。結果主要受政府價格管制預期影響以及日本非專利品牌報銷政策變動的影響。我們也看到澳洲某些產品存在競爭。

  • Lastly, we continue to see positive momentum in Greater China, where net sales exceeded expectations and grew 9%. This was primarily driven by our diversified commercial model and increased demand for our brands that are sensitive to proactive patient choice.

    最後,我們繼續看到大中華區保持正面勢頭,淨銷售額超出預期,成長了 9%。這主要是由於我們多元化的商業模式以及對我們重視患者主動選擇的品牌的需求不斷增長。

  • Net sales again benefited from the timing of customer purchasing patterns, which we expect to moderate in the fourth quarter. Moving to the remainder of the P&L, adjusted gross margin of 56% in the quarter was in line with our expectations. As anticipated, margins were impacted versus the prior year due to the indoor impact. Operating expenses were essentially flat versus the prior year.

    淨銷售額再次受惠於客戶購買模式的時機,我們預期這種模式在第四季會有所緩和。從損益表的其餘部分來看,本季調整後的毛利率為 56%,符合我們的預期。正如預期的那樣,由於室內活動的影響,利潤率與前一年相比受到了衝擊。營運費用與上年基本持平。

  • This was as a result of increased R&D spending driven by accelerated enrollment in our selatogrel and cenerimod clinical trial programs, which was offset by the continued benefit in SG&A from our 2025 cost savings initiatives. We continue to generate strong and durable free cash flow. This quarter, we generated $658 million of cash, which includes the impact of transaction-related costs.

    這是由於我們加快了 selatogrel 和 cenerimod 臨床試驗項目的招募,從而增加了研發支出,但 2025 年成本節約計劃帶來的 SG&A 持續收益抵消了這一支出。我們持續產生強勁且穩定的自由現金流。本季度,我們產生了 6.58 億美元的現金,其中包括交易相關成本的影響。

  • Excluding this impact, free cash flow would have been $728 million. Our significant free cash flow has enabled us to execute on our capital allocation plan. Since our Q2 call in August, we have repurchased an additional $150 million of shares, which brings our year-to-date total repurchases to $500 million, achieving the low end of our full-year range.

    排除這項影響,自由現金流將為 7.28 億美元。我們充裕的自由現金流使我們能夠執行資本配置計畫。自 8 月的第二季電話會議以來,我們又回購了價值 1.5 億美元的股票,使我們今年迄今的回購總額達到 5 億美元,達到了我們全年回購範圍的下限。

  • Including dividends paid, we have returned more than $920 million of capital this year to our shareholders. And we remain on track to deliver on our commitment of returning over $1 billion of capital this year. With regards to business development, the Aculys transaction highlights our ability to leverage our global infrastructure to strengthen our commercial portfolio in Japan through disciplined business development. The $35 million upfront payment is expected to be expensed as IPR&D in the fourth quarter.

    今年,包括支付的股息在內,我們已向股東返還了超過 9.2 億美元的資本。我們仍有望實現今年返還超過10億美元資本的承諾。就業務發展而言,Aculys 的交易凸顯了我們利用全球基礎設施,透過嚴謹的業務發展來加強我們在日本的商業組合的能力。預計這筆 3,500 萬美元的預付款將在第四季作為智慧財產權研發費用計入支出。

  • Now a few comments on our updated outlook and phasing for the remainder of the year. We are raising and narrowing our 2025 financial guidance ranges across certain metrics, primarily driven by foreign exchange as well as share repurchases completed year to date. Our outlook is supported by the continued strength of our underlying business performance.

    現在,我想就今年剩餘時間的最新展望和計劃做一些說明。我們正在提高和縮小 2025 年某些指標的財務預期範圍,主要受外匯波動以及今年迄今完成的股票回購的影響。我們的前景得益於公司基本面的持續強勁表現。

  • With respect to anticipated phasing in the fourth quarter, relative to our third-quarter results, total revenues are expected to be lower across all of our segments due to normal product seasonality, resulting in our third-quarter revenues being the highest quarter of the year. Gross margins are expected to be stable, and SG&A is expected to increase due to investments in our pipeline and upcoming launches to drive future growth.

    就第四季的預期進展而言,相對於我們第三季的業績,由於正常的季節性因素,我們所有業務部門的總收入預計都會下降,導致我們第三季的收入成為全年最高的季度。預計毛利率將保持穩定,而銷售、管理及行政費用預計將因對產品線和即將推出的產品的投資而增加,以推動未來的成長。

  • Lastly, free cash flow is expected to step down due to the timing of interest payments and the normal phasing of capital expenditures. As we close out the year, we expect the underlying positive fundamentals of the business to continue. As normal course, we will provide our outlook for 2026 in the first quarter of next year, along with our Q4 and full-year results.

    最後,由於利息支付的時間安排和資本支出的正常分階段進行,預計自由現金流將有所下降。隨著年末臨近,我們預計公司的基本面將繼續保持積極態勢。按照慣例,我們將在明年第一季發布 2026 年展望,以及第四季和全年業績。

  • However, from where we sit today, there are several dynamics to consider as we think about next year. These include the timing of approvals and uptake from recently launched products, competitive dynamics in North America, and potential loss of exclusivity for Amitiza in Japan. Investments supporting our pipeline and launch preparedness to drive future growth and the implementation of our enterprise-wide strategic review.

    然而,就我們目前所處的位置而言,在考慮明年時,有幾個因素需要考慮。這些因素包括近期推出的產品的批准和市場接受度、北美地區的競爭動態,以及 Amitiza 在日本可能會失去獨家經營權。投資支持我們的產品線和上市準備工作,以推動未來成長和實施我們全公司的策略審查。

  • In summary, we remain encouraged by the underlying fundamentals of our global business and the continued execution of our disciplined and balanced capital allocation plan. As Scott mentioned, we plan on hosting an investor event during the first quarter of next year, where we expect to provide our strategic and financial outlook, an update on our pipeline and portfolio, and details on our enterprise-wide strategic review.

    總之,我們對全球業務的基本面以及我們嚴謹均衡的資本配置計劃的持續執行感到鼓舞。正如 Scott 所提到的,我們計劃在明年第一季舉辦投資者活動,屆時我們將提供我們的策略和財務展望、產品線和投資組合的最新情況,以及我們企業範圍內的策略審查詳情。

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

    這樣,我就把電話交還給接線生,開始問答環節。

  • Operator

    Operator

  • We will now begin the question-and-answer session. (Operator Instructions)

    現在開始問答環節。(操作說明)

  • Les Sulewski, Truist.

    萊斯·蘇萊夫斯基,Truist。

  • Les Sulewski - Analyst

    Les Sulewski - Analyst

  • A couple for me. So first, perhaps maybe give us an update, if you could, on the Indore resolution situation.

    給我一對。首先,如果您方便的話,能否給我們更新印多爾決議的最新進展?

  • And then Second, if you look at through the branded portfolio across the regions, specifically 2 products that stand out in 3Q, one being the uptick in Lipitor, are you able to capture some of the share from the recent generic recall? And then second, what's driving the uptick in EpiPen given the options patients now have with the nasal spray and then also some shortages across that board.

    其次,如果你縱觀各個地區的品牌產品組合,特別是第三季度表現突出的兩款產品,其中一款是立普妥(Lipitor)的銷量增長,你能否從最近的仿製藥召回中搶佔一些市場份額?其次,考慮到患者現在有了鼻噴劑這種選擇,以及鼻噴劑普遍短缺,是什麼因素導致了EpiPen使用量的上升?

  • And then third, are there any key Paragraph IV challenges that you're facing into next year?

    第三,您在明年面臨哪些第四段的關鍵挑戰?

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Les, let me -- I'll answer the Indore question and then pass it on. So I have to say, we're very pleased with where we are from a remediation perspective. We're largely remediated at this point. We recently had a productive and open meeting with the FDA relative to not only the remediation process but reinspection. Timing of the reinspection is with the FDA. It's not under our control, likely they'll show up unannounced at some point in '26 and reinspect.

    萊斯,讓我來-我先回答印多爾的問題,然後再把它轉交給其他人。所以我必須說,從補救的角度來看,我們對目前的進展非常滿意。目前問題已基本解決。我們最近與 FDA 舉行了一次富有成效且坦誠的會議,不僅討論了整改流程,還討論了重新檢查事宜。複檢時間由美國食品藥物管理局 (FDA) 決定。這不在我們的控制範圍內,他們很可能會在 2026 年的某個時候不經通知就出現並重新檢查。

  • But I think it's really important to know that we've built redundancies by qualifying other sites and adding third-party vendors to try and decouple revenues from products on the import alert list and the Indore reinspection because the timing is out of our control. So I think the Indore remediation is going very, very well. And we just -- as I said, just recently talked to the FDA and had a very constructive meeting. I'll pass it over to Doretta.

    但我認為,了解我們已經透過對其他站點進行資格認證和增加第三方供應商來建立冗餘機制,從而努力將收入與進口警示名單上的產品和印多爾重新檢查脫鉤,這一點非常重要,因為時間是我們無法控制的。所以我認為印多爾的整治工作進展得非常順利。正如我剛才所說,我們最近與美國食品藥物管理局 (FDA) 進行了交談,並舉行了一次非常有建設性的會議。我把它交給多蕾塔。

  • Doretta Mistras - Chief Financial Officer

    Doretta Mistras - Chief Financial Officer

  • Great. Thanks. With respect to our branded regions. Number one, on Lipitor, that's really driven by the strength of our brand outside of the US, in particular, in China. We've talked about the strength of our portfolio there, especially in cardiovascular and all the work that we've done in terms of the channels that we operate, the strength of our brand has really continued to drive performance on Lipitor. With respect to EpiPen, we are, to your point, seeing solid performance in this year. I would say our share has remained relatively stable.

    偉大的。謝謝。關於我們的品牌區域。首先,就立普妥而言,這確實得益於我們在美國以外地區,特別是中國市場的強大品牌影響力。我們已經談到了我們在該領域的產品組合實力,尤其是在心血管領域,以及我們在營運管道方面所做的所有工作,我們品牌的實力確實持續推動了立普妥的業績。關於EpiPen,正如您所說,我們今年的確看到了良好的市場表現。我認為我們的市場佔有率一直保持相對穩定。

  • It's around 24% to 25% in the market. But to call out a couple of areas where we're seeing some strength. Number one, we relaunched EpiPen in Canada. We -- with the shift of commercial rights from Pfizer back to us. And secondly, we're seeing strong growth in Europe, and that's really led to the strength in EpiPen.

    市場上的比例大約在24%到25%之間。但我想特別指出幾個我們看到表現強勁的領域。第一,我們在加拿大重新推出了EpiPen。隨著輝瑞公司將商業權利轉移回給我們,我們—其次,我們看到歐洲市場強勁成長,這確實推動了 EpiPen 的發展。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • We're going to the next question, I just wanted to reemphasize, not only do we have a stated performance Lipitor in China, but the China affiliate in general had very strong third quarter and has a very -- had strong so far year-to-date this year. So we're very pleased with our progress in China.

    接下來是下一個問題,我只想再次強調,我們不僅在中國取得了立普妥的業績,而且中國子公司的第三季度整體表現非常強勁,今年迄今為止的業績也非常強勁。因此,我們對在中國的進展非常滿意。

  • Operator

    Operator

  • Matt Dellatorre, Goldman Sachs.

    Matt Dellatorre,高盛集團。

  • Matthew Dellatorre - Analyst

    Matthew Dellatorre - Analyst

  • Maybe on fast-acting meloxicam first, could you comment on any feedback thus far from the FDA regarding the potential for an opioid-sparing label. And how significant do you guys view that from an access and pricing perspective? And then could you comment on the partnership strategy to reach the broader market, including how do you guys think about the split in value between the channels that you will cover versus other segments that you might partner. And how much you structure a deal like that?

    或許可以先談談速效美洛昔康,您能否就 FDA 目前為止對該藥可能獲得阿片類藥物替代標籤的任何反饋發表一下看法?從准入和定價的角度來看,你們覺得這一點有多重要?那麼,您能否談談拓展更廣泛市場的合作策略,包括您如何看待所涵蓋管道與可能合作的其他細分市場之間的價值分配?你如何安排這樣的交易?

  • And then maybe just quickly on capital allocation. Could you maybe speak to the key priorities next year? Scott, I know you mentioned US-based BD. Just curious, would that be mostly midsized licensing deals? And how should we think about just kind of balance sheet capacity for those potential deals?

    然後或許可以簡單談談資本配置。您能否談談明年的主要工作重點?Scott,我知道你提到了總部位於美國的BD公司。我只是好奇,這些授權交易大多是中等規模的嗎?那麼,我們該如何考慮這些潛在交易的資產負債表容量呢?

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • I'll kick it over to Philippe to talk a little bit about meloxicam and then I can finish up with not only where the partnership discussions are, but also capital allocation priorities for '26.

    我將把主題交給 Philippe,讓他談談美洛昔康,然後我就可以總結一下合作關係的討論進展以及 2026 年的資本分配優先事項。

  • Philippe Martin - Chief R&D Officer

    Philippe Martin - Chief R&D Officer

  • Thanks, Scott. Thanks, Matt, for the question. So on fast-acting meloxicam, opioid-sparing specifically to your question. We've designed the Phase III study in collaboration with the FDA and designed the study in order to be able to get opioid-sparing language in the label. As you know, the data that came out of the 2 Phase III studies in both models in terms of opioid-sparing is very strong.

    謝謝你,斯科特。謝謝馬特的提問。所以,關於速效美洛昔康,特別是針對你的問題,減少鴉片類藥物的使用。我們與 FDA 合作設計了 III 期研究,並設計了該研究,以便在標籤中添加減少阿片類藥物使用的措辭。如您所知,在兩種模型中,兩項 III 期研究得出的數據在減少鴉片類藥物使用方面都非常強大。

  • And so we feel very encouraged with our ability to get opioid-sparing language in the label. We have a pre-NDA meeting with the agency over the next few weeks where we'll be discussing this as part of the meeting. It's one of the topics we'll be discussing. But like I said, I think from a labeling standpoint, we've done everything that can be done with very strong data to be able to get opioid-sparing in the label.

    因此,我們感到非常鼓舞,因為我們能夠在藥品標籤中加入減少阿片類藥物用量的措辭。接下來幾週,我們將與該機構舉行保密協議簽署前的會議,屆時我們將討論此事。這是我們將要討論的話題之一。但就像我說的,我認為從標籤的角度來看,我們已經盡了全力,憑藉非常強有力的數據,在標籤上加入了「減少阿片類藥物用量」的字樣。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • In terms of meloxicam partner, you're a little bit ahead of me in terms of segmentation and who covers what. We're involved with some discussions with potential partners, and we're working through that and what that would look like. Those are all sort of individual discussions and the specifics would depend on what partner we land with if we do land with the partner there. So we're actively involved in exploring discussions there. We also feel completely good to take this ourselves and commercialize ourselves.

    就美洛昔康的合作夥伴而言,你在細分市場和覆蓋範圍方面比我略勝一籌。我們正在與一些潛在合作夥伴進行洽談,並努力探討合作的具體形式。這些都是個別討論,具體細節取決於我們最終與哪家合作夥伴合作(如果我們最終真的與那家合作夥伴合作的話)。所以我們正在積極參與這方面的討論。我們也完全樂意自己進行生產和商業化。

  • We've got the right people. We've got great data, and we've got resources behind it to make a great launch. So we would only go into a partnership if we thought it was significantly additive to the overall value. And then in terms of our capital allocation priorities going to into '26, let me just -- there's a word that I try and use all the time here, and that's balanced, right?

    我們找到了合適的人選。我們擁有出色的數據,也擁有足夠的資源來實現一次成功的發布。因此,只有當我們認為合作能顯著提升整體價值時,我們才會進行合作。至於我們到 2026 年的資本配置優先事項,讓我先說一句——我一直試圖在這裡使用一個詞,那就是平衡,對吧?

  • We're going to continue to be balanced in terms of our capital allocation. As I've talked about many times over a three-, five-year period, we're going to try and be 50-50 returning capital to shareholders, but also trying to build a portfolio of growth assets. And so we'll be involved in business development as well. I love the deal that we did with Aculys in Japan. Japan is a key strategic priority for us.

    我們將繼續保持資本配置的平衡。正如我在過去三到五年內多次談到的那樣,我們將努力做到 50% 向股東返還資本,同時也將努力建立一個成長型資產組合。因此,我們也會參與業務拓展。我非常喜歡我們與日本Aculys公司達成的合作協議。日本是我們的重要戰略優先事項。

  • We put a couple of innovative assets in there to launch in '26. And we're going to continue to look for things for assets that we could be good owners of. I would love to be able to find some in-market accretive US-based innovative products to add to the portfolio. And we're working hard on it. And again, but we're -- overall, we're going to continue to be very balanced in terms of our capital allocation between return to shareholders and also doing business development.

    我們在裡面投入了一些創新資產,並計劃在 2026 年推出。我們將繼續尋找我們能夠成為優秀所有者的資產。我非常希望能夠找到一些具有市場增值潛力的美國本土創新產品,並添加到產品組合中。我們正在為此努力。再次重申,總體而言,我們將繼續在股東回報和業務發展之間保持資本配置的平衡。

  • And it depends a little bit -- every year is going to be a little bit different. This is the year so far, we've leaned into share buybacks given the uncertainty in the environment, the share price and other things. And other years, we may lean into business development a little bit more, but we want to be able to do both return and also build growth assets to sit on top of the strong base business we have to really return to long-term profitable growth for the company.

    這要視情況而定——每年都會略有不同。今年以來,鑑於市場環境、股價及其他因素的不確定性,我們採取了股票回購策略。其他年份,我們可能會更專注於業務拓展,但我們希望既能實現回報,又能建立成長資產,以鞏固我們強大的業務基礎,從而真正實現公司的長期盈利增長。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    克里斯‧肖特,摩根大通。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Just two for me. Maybe just coming back to the enterprise-wide strategic review. Just any more color you can provide on the quantum of expense reduction we should be thinking about here? And when you mentioned reinvestment, is that a majority of those savings, a small portion? Just any -- just kind of directional color of just how we should think about that flow through? I know we're going to get more color next year, but just anything you can provide today.

    我只有兩個。或許應該回到企業整體策略評估。關於我們應該考慮的削減開支幅度,您還能提供更多細節嗎?您提到的再投資是指大部分儲蓄,還是一小部分?只是任何一種——只是某種方向性的顏色,用來指示我們該如何思考這種流動?我知道明年我們會有更多的色彩,但今天你能提供什麼就提供什麼吧。

  • And maybe, Scott, just building on the comments you just made about the balanced approach to capital deployment. You mentioned this year is more of a capital return year. And just when you look at kind of the range of BD opportunities out there, balancing the stock price, like should we think about '26 looking more like '25, where it is more kind of capital return? Or directionally, does '26 look more like that 50-50 balance that you're targeting over time?

    史考特,或許可以就你剛才關於資本部署平衡方法的評論做進一步探討。您提到今年更專注於資本回報。當你審視市場上各種各樣的 BD 機會時,平衡股價,例如我們是否應該認為 2026 年會更像 2025 年,更注重資本回報?或者從方向上看,'26 年是否更接近您長期追求的 50-50 平衡?

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Yes. Thanks, Chris. So in terms of quantum, I don't want to get into quantum of savings at this point in time. We will be very, very clear and transparent relative to the quantum of savings that we get from the enterprise-wide review when we get into Q1, either at the call or through an investor event, but we'll be very, very clear about that. We're working hard on that. We think the quantum of savings is going to be significant. We believe we're going to be able to deliver meaningful cost savings over a multiyear period. And so we expect it to be pretty significant.

    是的。謝謝你,克里斯。所以就量子層面而言,我現在不想討論節省的量子層面。我們將在進入第一季時,透過電話會議或投資者活動,非常、非常清楚地說明我們從企業範圍審查中獲得的節省金額,但我們會對此非常非常清楚。我們正在為此努力。我們認為節省的金額將會非常可觀。我們相信,在未來幾年內,我們將能夠實現顯著的成本節約。因此,我們預計這將意義重大。

  • Right now, we're sort of focused on commercial sales, marketing model, product mix, R&D, medical and regulatory activities, sourcing, manufacturing, supply chain, inventory optimization, corporate support functions. So it's a large project. We're looking at the whole organization, and we expect to be able to deliver meaningful cost savings, and we'll get into the exact quantum of those as we as we get into Q1.

    目前,我們主要關注商業銷售、行銷模式、產品組合、研發、醫療和監管活動、採購、製造、供應鏈、庫存優化、公司支援職能。所以這是一個大項目。我們正在審視整個組織,並期望能夠實現顯著的成本節約,我們將在第一季公佈具體的節約金額。

  • And we won't only talk about the quantum, but we'll also talk about phasing. We'll also talk about the magnitude of reinvestment, et cetera, at that event, either with the call or in the investor event. I do not see reinvestment being the majority of savings. I think it will be -- certainly, the minority will be likely putting more into savings and dropping to the bottom line than reinvestment, but there will be some significant reinvestments as well.

    我們不僅會討論量子力學,還會討論相位學。屆時,我們也會討論再投資的規模等等,無論是透過電話會議或是投資者會議。我不認為再投資會佔據儲蓄的大部分。我認為情況會是這樣——當然,少數人可能會把更多的錢存起來,用於儲蓄和降低成本,而不是進行再投資,但也會出現一些重要的再投資。

  • So this is not about redistributing as much, as it's about finding the savings and then making sure we're looking after the base business and looking after our future growth as well.

    所以,這與其說是重新分配,不如說是尋找節省開支的方法,然後確保我們既能照顧好基礎業務,又能照顧好未來的成長。

  • The last question was balance. So what's '25 going to look like from -- '26, sorry, from a capital allocation perspective, we'll have to wait and see what that year looks like, what opportunities are there, where the stock is trading at. Again, I don't look at it on a yearly basis. I look at it sort of over a longer period, a 3- to 5-year period that we want to be very balanced in returning that capital allocation.

    最後一個問題是平衡。那麼,從資本配置的角度來看,2025 年會是什麼樣子——抱歉,是 2026 年,我們得等等看那一年的情況,看看有哪些機會,股票的交易價格是多少。我再次強調,我不會照年來看待這個問題。我是從更長遠的角度來看這個問題的,希望在 3 到 5 年的時間內,在資本配置方面保持非常平衡。

  • As things evolve, again, as we get into guidance for '26, we may talk a little bit more about that. But again, I want to continue to be able to do both, return to shareholders, but also build a portfolio of assets that are going to fuel our growth in the future.

    隨著情況的發展,當我們開始製定 2026 年的業績指引時,我們可能會更談到這一點。但是,我希望能夠繼續做到這兩點:既要回報股東,又要建立一個能夠推動我們未來成長的資產組合。

  • Operator

    Operator

  • [Dennis Ding], Jefferies.

    [丹尼斯丁],傑富瑞。

  • Liwen Wang - Analyst

    Liwen Wang - Analyst

  • This is Liwen Wang for Dennis Ding. Our question is about meloxicam. What is your overall confidence in the self-ramp and peak sales potential? And if there's anything to be learned from competitor journavx [slow] launch?

    這是李文王,代表丁丹尼。我們的問題是關於美洛昔康的。您對自主成長和銷售高峰潛力有多大信心?如果能從競爭對手journavx緩慢的發布策略中學到一些經驗教訓呢?

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Yes. So I think just let me comment and then maybe Philippe can talk a little bit about the data. But we're very excited about meloxicam. The combination of the data and the people we have on board, I think we can do a very significant launch here. Whether peak sales, $0.5 billion, I think that's in the right sort of range. But we'll be more clear about that again as we get into '26 and get ready for launch. We do not have a label on that yet. So part of that -- I think there's great potential here. We can be more specific what those peak sales look like once we understand what the label looks like once the full plans together.

    是的。所以我想先讓我發表一下看法,然後也許菲利普可以稍微談談數據。但我們對美洛昔康感到非常興奮。我認為,結合我們擁有的數據和人員,我們可以在這裡取得非常顯著的成果。無論是銷售峰值,還是 5 億美元,我認為這個數字都在合理的範圍內。但到了 2026 年,當我們準備發布產品時,我們會對此有更清楚的說明。我們目前還沒有給它貼標籤。所以,我認為這裡蘊藏著巨大的潛力。一旦我們了解了整個計劃制定完成後,該品牌的面貌,我們就可以更具體地描述銷售高峰期的情況了。

  • I will say we've got an excellent team on this right now. They've launched multiple blockbusters before. We feel very, very good not only about the data, but our ability to commercialize this asset. We're going to commercialize it as if it's a branded product, it's got -- we think there's significant exclusivity there. We're looking to expand that exclusivity. And we expect meloxicam to be a very meaningful contributor to our portfolio for the rest of this decade at a minimum and maybe longer than that. So we're very excited about it.

    我想說,我們現在擁有一支非常優秀的團隊。他們之前也推出過多部票房大片。我們不僅對數據感到非常非常有信心,而且對我們實現這項資產商業化的能力也充滿信心。我們將把它商業化,就像一個品牌產品一樣,我們認為它具有——我們認為它具有重要的獨特性。我們希望擴大這種專屬性。我們預計,至少在本十年剩餘的時間裡,美洛昔康將成為我們產品組合中非常重要的組成部分,甚至可能更長。所以我們對此感到非常興奮。

  • Operator

    Operator

  • Umer Raffat, Evercore ISI.

    Umer Raffat,Evercore ISI。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • Congrats on the quarter. This is JP for Umer. A couple of questions on meloxicam and the presbyopia medicine. Meloxicam, as you finalize your planning, what kind of payer guidelines engagement are you thinking? Is it going to be a multimodal pain pathways? Or how does it work versus traditional retail channels. And on presbyopia, is this going to be more of a cash pay optometry play initially? Or do you see a path to broader reimbursement and physician adoption as the category matures?

    恭喜你本季取得佳績。這是日文烏麥爾的意思。關於美洛昔康和老花眼藥物,我有幾個問題。Meloxicam,在您最終確定治療方案時,您考慮的是與支付方進行哪些方面的溝通?它會是多模式疼痛路徑嗎?或者說,它與傳統零售通路相比有何不同?至於老花眼,最初是否會更採用現金支付的驗光服務模式?或者,您認為隨著該領域的成熟,會有更廣泛的報銷和醫生採用的途徑?

  • Philippe Martin - Chief R&D Officer

    Philippe Martin - Chief R&D Officer

  • So let me start with meloxicam. I think what we've experienced both from, I think, a payer, but also from a KOL standpoint is the fact that this is the pain -- the acute pain market has moved to a multimodal approach where, generally speaking, patients are discharged with a couple of medications. And that we believe we'll be able with the data we have to leverage that trend within the market. So our data supports that positioning.

    那麼,就讓我先從美洛昔康開始吧。我認為,無論是從支付方還是從關鍵意見領袖的角度來看,我們都體會到,這就是疼痛所在——急性疼痛市場已經轉向多模式治療方法,一般來說,患者出院時會服用幾種藥物。我們相信,憑藉我們掌握的數據,我們將能夠利用市場中的趨勢。因此,我們的數據支持這一定位。

  • And -- I'm not sure what I -- can't recall on the second question was.

    至於第二個問題,我不太確定我──我記不起來了。

  • William Szablewski - Head of Capital Markets

    William Szablewski - Head of Capital Markets

  • Second question on presbyopia.

    關於老花眼的第二個問題。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Prebyopia and payer channels and commercialization. So we'll hand that over to Doretta.

    老花眼、支付管道和商業化。所以我們會把這件事交給多蕾塔。

  • Doretta Mistras - Chief Financial Officer

    Doretta Mistras - Chief Financial Officer

  • Yes. Thank you. And we're still working through both not only our presbyopia but also our dim light disturbance strategy as we get closer to commercialization. But taking a step back, we view this more as a portfolio approach. When you couple that with tyrvaya that's already in the market as well as ryzumvi, we have the opportunity to really create a portfolio of assets that tailor to the front of the eye.

    是的。謝謝。隨著我們越來越接近商業化,我們仍在努力解決老花眼問題以及低光源幹擾策略。但退一步講,我們更將其視為一種投資組合策略。再加上市場上已有的 tyrvaya 和 ryzumvi,我們就有機會真正打造出專為眼前之物量身打造的資產組合。

  • But we're ultimately still working through the commercialization strategy. Given the indication, it is natural to assume there will be a large cash pay component to it, but we'll be able to provide more details as we get closer to commercialization.

    但我們最終仍在製定商業化策略。根據目前的跡象,很自然地會認為其中會包含大量的現金支付部分,但隨著商業化進程的推進,我們將能夠提供更多細節。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Yes. We're very pleased with the direction we're going with the Eye Care group. We've got some new leadership on that team. A couple of positive readouts, obviously, this year in presbyopia and dim light. And we'll see what those labels look like. But we're putting -- starting together a portfolio of assets in the eye care area and starting to get some critical mass in terms of that particular group.

    是的。我們對眼科護理團隊的發展方向感到非常滿意。我們團隊迎來了一些新的領導階層。今年在老花眼和弱光治療方面,顯然有一些積極的進展。讓我們來看看這些標籤長什麼樣子。但我們正在著手建立眼科護理領域的資產組合,並開始在該特定領域累積一定的規模。

  • Operator

    Operator

  • Ash Verma, UBS.

    阿什維爾馬,瑞銀集團。

  • Ashwani Verma - Analyst

    Ashwani Verma - Analyst

  • Congrats on all the progress. So maybe one for Scott. So for the strategic review, I know you don't want to comment on the quantum of savings. But just in terms of the order of priority here, is that the right way to think about how you spend it out as in there's more potential for savings from commercial, followed by R&D and then COGS?

    祝賀你們取得的所有進展。所以,也許斯科特會喜歡這個。所以,在策略評估中,我知道您不想對節省的金額發表評論。但就優先順序而言,這種考慮支出方式是否正確,即商業支出有更大的節省潛力,其次是研發支出,最後才是銷售成本?

  • And then secondly, for Doretta, so as we think about like the top line for 2026 versus 2025, can you talk about the pushes and pulls? I see at this guidance of '25 midpoint, you have $350 million of FX tailwind. So that laps next year? And then in terms of the new product contribution, do you think that you can deliver the sort of the [reference] you've been at the $450 million to $550 million.

    其次,對 Doretta 來說,當我們考慮 2026 年與 2025 年的業績對比時,你能談談其中的推動因素和拉力因素嗎?我認為按照 2025 年中點的預期,你們將獲得 3.5 億美元的外匯順風。所以明年會有幾圈?那麼就新產品貢獻而言,您認為您能否達到您一直以來所取得的 4.5 億美元至 5.5 億美元的業績水準?

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • Yes. So let me take the enterprise-wide strategic review, and then we'll pass it around the table here to answer your question. So Ash, thank you very much for the question. We're not trying to -- we're trying to be as open and honest and transparent as possible with the enterprise strategic review and where we are. We're not trying to be cute with it. The reason we're not giving a quantum is because it's a big project. It's a big company.

    是的。那麼,讓我先進行一次全公司範圍的策略評估,然後我們輪流進行,來回答您的問題。所以,Ash,非常感謝你的提問。我們並非試圖——我們只是想在企業策略評估以及我們所處的位置方面盡可能地公開、誠實和透明。我們並不是想耍花招。我們不給出量子力學解釋的原因是,這是一個大項目。這是一家大公司。

  • We're looking at everything. We want to be able to not only identify it, but we want to be able to trace it back and lock it down with the individual groups that we're working with there so that we come with a number that's accurate, sustainable and durable, and we can hold on to that number over a number of years. So we're trying to make sure that not only do we identify things but we understand and map out the activities needed to be able to really realize those savings.

    我們正在調查所有情況。我們不僅希望能夠識別它,還希望能夠追溯它的源頭,並與我們正在合作的各個團體鎖定它,以便我們能夠獲得一個準確、可持續和持久的數字,並且我們可以在未來幾年內保持這個數字。因此,我們不僅要確保發現問題,還要了解並制定真正實現這些節省所需的活動。

  • In terms of the things that we're looking at, sales and marketing, R&D, operations, corporate support. I think probably the largest quantum can come from our sourcing, manufacturing, supply chain, inventory optimization. There's a significant amount that can come from corporate support as well.

    就我們關注的方面而言,包括銷售和行銷、研發、營運、公司支援。我認為最大的提升空間可能來自於我們的採購、製造、供應鏈和庫存優化。此外,企業贊助也能提供相當可觀的資金。

  • And some of the commercialization and the way that we're commercialized and the way that we need to not only sort of prepare for today and be able to continue to deliver today, but we want to be able to understand the functions that we need to be able to commercialize in the future. So we want to be fit for purpose for today and for tomorrow with this.

    還有一些商業化方式,以及我們實現商業化的方式,我們不僅需要為今天做好準備,並能夠繼續提供今天的服務,而且我們還希望能夠了解我們將來需要實現商業化的功能。所以我們希望它能夠滿足當下和未來的需求。

  • It's not just about realizing cost savings. It's also about evolving our model to be more effective going forward as well. So we really look forward to being in a place to talk exactly about the quantum of exactly where it's coming from, what the phasing is by year, with the reinvestment opportunities on things, and we're going to be able to do that in Q1. But we're not trying to -- again, to be cute here. We're trying to be accurate. We're trying to be thoughtful, and we're trying to make sure that we give numbers that we can deliver on.

    這不僅僅是節省成本的問題。同時,這也關係到我們如何改進模式,使其在未來更有效。因此,我們非常期待能夠詳細討論資金的具體來源、每年的分階段實施計劃以及再投資機會,我們將在第一季實現這一點。但我們並不是想──再說一遍,我們不是想賣萌。我們力求做到準確。我們力求深思熟慮,並努力確保我們給予的數字是我們能夠兌現的。

  • Doretta Mistras - Chief Financial Officer

    Doretta Mistras - Chief Financial Officer

  • With respect to your question around 2026 revenue, without getting into specific guidance, our focus this year is really finishing the year strong. We're very happy with the momentum that we're seeing in the business. We remain on track to deliver the 2% to 3% operational revenue growth for the year, excluding Indore. And we expect the underlying positive fundamentals that we're seeing in the business to continue into 2026.

    關於您提出的 2026 年營收問題,我們不打算給出具體指引,但我們今年的重點是力爭在年底前取得強勁的收官成績。我們對目前業務的發展動能非常滿意。除印多爾地區外,我們仍有望實現全年 2% 至 3% 的營運收入成長目標。我們預計目前業務中呈現的正面基本面將持續到 2026 年。

  • And as I think about the pushes and pulls to your point, number one, continued performance in our commercial business, including Europe, China and emerging markets, it's also going to depend on the timing of approvals and uptake of recently launched products as well as the competitive dynamics in North America and the potential loss of exclusivity for amitiza in Japan. But as normal course, we will provide our outlook for 2026 in the first quarter of next year.

    至於你提到的各種推拉因素,首先,我們商業業務(包括歐洲、中國和新興市場)的持續表現,還要取決於近期推出的產品的審批和市場接受度,以及北美市場的競爭動態,還有amitiza在日本可能失去獨家經營權的情況。但按照慣例,我們將在明年第一季發布對 2026 年的展望。

  • With respect to your second question around new product revenue and how that ties into 2026. We've talked about the $450 million to $550 million without getting into specifics, we will provide that next year. We are also seeing positive momentum of our new product revenues going into 2026 just based on the number of opportunities not only that have gotten approved like iron sucrose but the ones that are currently under regulatory review, including octreotide.

    關於您提出的第二個問題,即新產品收入以及這與 2026 年的關係。我們之前討論過 4.5 億美元到 5.5 億美元,但沒有具體說明,明年我們會公佈具體細節。我們也看到,到 2026 年,我們的新產品收入將保持積極勢頭,這不僅得益於像蔗糖鐵這樣已經獲得批准的產品,還得益於目前正在接受監管審查的產品,包括奧曲肽。

  • And so we will provide more information next year when we provide our full year.

    因此,我們將在明年公佈全年業績時提供更多資訊。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • And I feel -- personally, I feel very good about '26 and the new product revenue. A lot of the approvals this year were back ended in the back half of the year. We've got some more approvals to come. We've got a lot of launches coming in '26 as I went through earlier, that are going to be catalysts. So I feel very, very good about where our new product number is going to be for '26.

    就我個人而言,我對 2026 年和新產品的收入感覺非常好。今年很多審批都是在下半年才進行的。我們還有一些審批工作正在進行中。正如我之前提到的,我們在 2026 年有許多產品即將上市,這些產品將成為催化劑。所以我對我們 2026 年的新產品銷售感到非常非常滿意。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    大衛·阿姆塞勒姆,派珀·桑德勒。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • So just some pipeline questions, brand pipeline questions. So just back to presbyopia, can you talk to how you see differentiation versus the other modalities that have come on the market. So that's number one.

    所以,一些關於產品線的問題,品牌產品線的問題。回到老花眼的話題,您能否談談您認為它與其他已上市的治療方法有何不同?這是第一點。

  • Number two, on cenerimod. Just wanted to get more insight into your thought process regarding running the study now in lupus nephritis. Is that informed by any additional analyses of earlier data? Or is it something of potentially a hedge to the extent SLE isn't successful? Just wanted to get your thought process there. And then lastly, on the rapid acting meloxicam, can you just remind us how you're thinking of your IP/exclusivity runway for that product?

    第二點,關於cenerimod。我只是想更深入地了解您關於現在開展狼瘡性腎炎研究的思考過程。這結論是否參考了對早期數據的其他分析?或者說,這是否可以作為一種對沖手段,以防 SLE 不成功?我只是想了解你的思考過程。最後,關於速效美洛昔康,您能否提醒我們一下,您是如何考慮該產品的智慧財產權/獨家經營權的?

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • So let me hand it to Philippe for presbyopia and cenerimod.

    所以,我要把老花眼和cenerimod的功勞歸於Philippe。

  • Philippe Martin - Chief R&D Officer

    Philippe Martin - Chief R&D Officer

  • Yes. So I think for presbyopia in terms of differentiation versus other mechanism of action. I think the miotics in general, do stimulate the ciliary muscle, and that leads to a number of potential issues, including risk of retinal tear or detachment, and a reduction in vision in dim and dark environment, which we certainly don't see with our drug. We actually see the reverse. So we think that from a benefit risk profile, our drug is differentiated. It is both effective and safe. So that's, I think, where we can see the most differentiation from MR-141.

    是的。所以我認為,對於老花眼來說,差別在於與其他作用機制的差異。我認為縮瞳劑通常會刺激睫狀肌,這會導致許多潛在問題,包括視網膜撕裂或剝離的風險,以及在昏暗和黑暗環境中視力下降,而我們的藥物肯定不會出現這些問題。實際上我們看到的情況恰恰相反。因此,我們認為從獲益風險比來看,我們的藥物具有差異化優勢。它既有效又安全。所以,我認為,這就是我們能看出它與 MR-141 最大區別的地方。

  • The second question about cenerimod. Cenerimod, if you look at the Phase II data, you'll see that cenerimod tends to work better in more severe patients, patients that tend to look like lupus nephritis patients. And so on top of it, the mechanism of action applies to both SLE and lupus nephritis. So I think it's just a natural evolution of the asset leveraging the opportunity we have with the S1P mechanism of action that is pretty broad and can be applied to a number of autoimmune disease, lupus nephritis just makes sense based on the data we have.

    關於cenerimod的第二個問題。如果你查看 Cenerimod 的 II 期數據,你會發現 cenerimod 對病情更嚴重的患者(例如狼瘡性腎炎患者)往往效果更好。此外,此作用機轉同時適用於系統性紅斑狼瘡及狼瘡性腎炎。所以我認為這只是該資產的自然演變,利用了我們擁有的 S1P 作用機制的機會,該機制非常廣泛,可以應用於多種自體免疫疾病,根據我們掌握的數據,狼瘡性腎炎是合理的。

  • And like I said, the mechanism of action. So it's -- we're not hedging anything at all. We're just getting -- expanding our opportunity with cenerimod.

    正如我所說,作用機制。所以——我們根本沒有採取任何對沖措施。我們正在利用 cenerimod 來擴大我們的機會。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • I just want to reemphasize the last part that Philippe said there, we are not in any way hedging the SLE trial with a lupus nephritis. We feel very, very good about SLE. We feel good about the molecule. We see an opportunity, as Philippe said, to expand. So we're going to go ahead and start that study and start dosing patients now. So in no way is that a hedge, I think more than anything shows confidence that we have in the molecule going forward.

    我只想再次強調菲利普剛才說的最後一點,我們絕不會以狼瘡性腎炎為由對 SLE 試驗進行任何妥協。我們對SLE的病情感覺非常好。我們對這種分子感覺很好。正如菲利普所說,我們看到了擴張的機會。所以我們將著手進行這項研究,現在就開始給病人用藥。所以這絕不是一種對沖策略,我認為這更表明了我們對該分子未來發展的信心。

  • Lastly, I think your third -- your last question was IP around meloxicam. We see right now based on -- we see exclusivity in the 4- to 5-year range right now based on what we have, but we're very actively working on expanding that IP suite to be able to extend that exclusivity very significantly. Again, I sort of look at it as being a very meaningful contributor to the portfolio for this whole decade. And hopefully, we can expand beyond that. So a very important molecule for us. We're working very hard to expand our IP network there and also obviously expand the exclusivity that we have with the molecule.

    最後,我認為你的第三個問題——你的最後一個問題是關於美洛昔康的 IP 位址。就我們目前所掌握的情況來看,獨家經營權目前可以維持 4 到 5 年,但我們正在積極努力擴展智慧財產權組合,以便能夠大幅延長獨家經營權。再說一遍,我認為它在過去十年中對我的投資組合做出了非常有意義的貢獻。希望我們能在此基礎上更進一步。所以,這對我們來說是一種非常重要的分子。我們正在努力擴大我們在那裡的智慧財產權網絡,並且顯然也在擴大我們對該分子的獨家使用權。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    傑森‧格伯里,美國銀行。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • A couple for me. A lot of my questions have been answered. But just on the enterprise review and just why not an update today versus giving the update on 1Q '26. Is it that effectively, those efforts are still ongoing or that you need to assess maybe some of the cost of commercial buildouts that need to be offset? Or is it just wanting to have a forum next year that you could really get into the details with investors in 3Q is just not the best forum for that? So that's my first question.

    給我一對。我的很多疑問都得到了解答。但就企業審查而言,為什麼不今天就發布更新,而是發布 2026 年第一季的更新呢?效果真的如此顯著嗎?這些努力仍在繼續嗎?或者您需要評估可能需要抵消的一些商業建設成本?或者,你只是想在明年舉辦一個可以與投資者深入探討細節的論壇,但第三季並不是最佳的論壇時機?這是我的第一個問題。

  • And then just as a follow-up on Indore next year, in a scenario where, I guess, the ban isn't lifted, do the price penalties, which I think were $100 million, did they recur in that scenario? Or are they nonrecurring? I just wanted to understand that dynamic a little bit better.

    那麼,作為對明年印多爾事件的後續跟進,假設禁令沒有解除,那麼價格罰款(我認為是 1 億美元)在這種情況下是否會再次發生?或者它們是一次性的?我只是想更好地理解這種動態關係。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • So I'll take the enterprise-wide review question and then kick the Indore over to Doretta to answer for us. She's very deep on Indore and what '26 looks like for that. It's not that we're holding things back. If we were ready to go with the enterprise-wide review, we would certainly give it to you guys right now, we'd be very clear. It's a big company. We're operating in 165 countries. We're looking at everything, commercial, marketing, product mix, R&D, medical, regulatory, sourcing, manufacturing, supply chain, we're looking at it all.

    所以我先回答全公司範圍的審查問題,然後把印多爾的問題交給多雷塔來回答。她對印多爾以及2026年的情況非常了解。並不是我們故意拖延。如果我們準備好進行全公司範圍的審查,我們肯定會現在就告訴你們,我們會說得很清楚。這是一家大公司。我們的業務遍及165個國家。我們正在考察所有方面,包括商業、行銷、產品組合、研發、醫療、監管、採購、製造、供應鏈,我們統統都要考察。

  • It's a very large and complex project that we're engaged in. It's absolutely the right time for us to be doing this now, right? The work we've done over the last five years, strengthening the balance sheet, paying down debt, divesting noncore assets, investing in innovation. It's just the right time for us to be doing it. We initiated this project sort of, I would say, late in Q1 of this year. And by the end of the year, we'll have a very good handle on it.

    我們正在參與一個非常龐大且複雜的專案。現在正是我們做這件事的最佳時機,對吧?過去五年,我們做了大量工作,包括加強資產負債表、償還債務、剝離非核心資產以及投資創新。現在正是我們做這件事的最佳時機。這個計畫我們大概是在今年第一季末啟動的。到年底,我們就能很好地掌控局面了。

  • And again, to me, it's not just about identifying where the cost savings might be. It's mapping those back to the organizations that are going to give, putting the action plans in place, being credible in terms of living with the number that we give you, and we want to be able to talk not only about the effect of the strategic review in '26 but also '27 and '28. The reason we're doing it then, not now is about accuracy. It's about us having numbers that we can live with.

    再次強調,對我來說,這不僅僅是找出可以節省成本的地方。我們要把這些與將要捐贈的組織聯繫起來,制定行動計劃,確保我們給出的數字具有可信度,我們希望不僅能夠談論 2026 年戰略審查的影響,還能談論 2027 年和 2028 年的影響。我們之所以選擇那時而不是現在這樣做,是為了確保準確性。關鍵在於我們要有可以接受的數字。

  • It's about us being transparent and believable. It's got nothing to do with holding it back, so we have something to talk about next year. If it was available, we get it to you, but it's a big project. And we want to be clear, transparent and credible when we put those numbers out, and we want to make sure they're mapped back in the organization. So we're holding ourselves accountable to delivering on those numbers.

    關鍵在於我們要做到透明和可信。這跟埋沒它無關,這樣我們明年就有話題可聊了。如果可以的話,我們會盡快給您,但這需要花費很多時間。我們希望在公佈這些數據時做到清晰、透明和可信,並且我們希望確保這些數據能夠反映在組織內部。因此,我們要對自己負責,確保實現這些目標。

  • Doretta Mistras - Chief Financial Officer

    Doretta Mistras - Chief Financial Officer

  • With respect to your question specifically around penalties, [Chris]. So the $100 million incorporates both penalties and supply disruptions a little over, I would say, 50% specifically relates to penalties. Those we do not expect to even independent of Indore, those will not materialize. We don't expect them to materialize again next year.

    關於您提出的有關處罰的具體問題,[克里斯]所以這 1 億美元包含了罰款和供應中斷的損失,其中超過 50% 的損失與罰款有關。那些我們預計即使獨立於印多爾也不會發生的事情,就不會發生。我們預計它們明年不會再次出現。

  • However, I do also would comment that we've been working in the background, not only to remediate Indore, but also to create redundancies within our network and our third parties in order to reestablish supply outside of Indore. And we do expect, regardless of the impact to see some stabilization of that as we move into next year.

    不過,我也想補充一點,我們一直在幕後努力,不僅是為了修復印多爾,也是為了在我們的網路和第三方中建立冗餘機制,以便在印多爾以外的地方重新建立供應。我們預計,無論影響如何,隨著我們進入明年,這種情況都會趨於穩定。

  • Operator

    Operator

  • This concludes our question-and-answer session. I would like to turn the conference back over to Scott Smith, CEO, for any closing remarks.

    我們的問答環節到此結束。我謹將會議交還給執行長史考特·史密斯,請他作總結發言。

  • Scott Smith - Chief Executive Officer, Director

    Scott Smith - Chief Executive Officer, Director

  • So first of all, thank you, everybody, on the call for your thoughtful detailed questions. Secondly, some closing remarks here, '25 has been -- is proving to be a really pivotal year for us, one where we're delivering results today while building a stronger, leaner, more innovative Viatris for tomorrow. I'd like to send a sincere thank you to the more than 30,000 employees of Viatris. A lot of good and hard work has been done to get us to this place.

    首先,感謝各位參與電話會議並提出了許多深思熟慮、細緻入微的問題。其次,最後我想說幾句,2025 年對我們來說是至關重要的一年,我們今天取得了成果,同時也在為明天打造一個更強大、更精簡、更具創新性的 Viatris。我謹向 Viatris 的 3 萬多名員工致以誠摯的謝意。我們走到今天這一步,凝聚了許多人的努力。

  • We're moving forward with confidence and excitement for the future. We see sustained profitable growth ahead and are actively executing on all key strategic priorities. I believe we are very well positioned to continue to deliver strong results and significant value for our shareholders. Thank you for listening.

    我們滿懷信心和熱情地向前邁進,對未來充滿期待。我們預計未來將持續實現獲利成長,並正在積極執行所有關鍵策略重點。我相信我們完全有能力繼續為股東帶來強勁的業績和巨大的價值。謝謝聆聽。

  • Operator

    Operator

  • The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

    會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。