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Operator
Operator
Good day, everyone, and welcome to the Viatris second-quarter 2025 earnings conference call. (Operator Instructions). Please also note, today's event is being recorded. At this time, I would like to turn the floor over to Bill Szablewski, Head of Investor Relations. Sir, please go ahead.
大家好,歡迎參加 Viatris 2025 年第二季財報電話會議。(操作員指令)。另請注意,今天的活動正在被記錄下來。現在,我想把發言權交給投資人關係主管 Bill Szablewski。先生,請繼續。
William Szablewski - Head of Investor Relations
William Szablewski - Head of Investor Relations
Good morning, everyone. Welcome to our Q2 2025 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. 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 risks and uncertainties.
大家早安。歡迎參加我們的 2025 年第二季財報電話會議。今天與我們在一起的有我們的執行長 Scott Smith、財務長 Doretta Mistras、首席研發長 Philippe Martin 和首席商務官 Corinne Le Goff。在今天的電話會議中,我們將就一些事項做出前瞻性陳述,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。
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.
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 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 are making comparisons to our 2025 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.
在討論 2025 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 2024 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 2024 年期間完成的剝離的比例結果。我們可以將這些稱為基於操作的變化。當將我們 2025 年的實際報告結果與我們的預期進行比較時,我們正在與我們的 2025 年財務指導進行比較。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)。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
Good morning, everyone. We delivered strong second quarter performance and stayed sharply focused on our key 2025 strategic priorities, which are driving strong commercial execution across our global business of generics and established brands, advancing our late-stage pipeline to drive future innovation, continuing to look at strategic accretive in-market business development opportunities to drive near and midterm growth, progressing our enterprise-wide strategic review to position Viatris for sustainable growth in '26 and beyond and returning capital to shareholders through dividends and share buybacks.
大家早安。我們在第二季度取得了強勁的業績,並高度關注我們 2025 年的關鍵戰略重點,即推動我們全球仿製藥和知名品牌業務的強勁商業執行,推進我們的後期產品線以推動未來創新,繼續尋找戰略增值的市場業務發展機會以推動近期和中期增長,推進我們全企業的戰略審查,使 Viatris 在 26 年以後和股票收益增長,還向股東返還實現收益。
Let me begin with a few highlights from our second quarter performance. We achieved 3% divestiture-adjusted operational revenue growth, excluding the impact from Indore, driven primarily by strength in Europe and the Greater China region. These results reflect the strength of our execution and the resilience of our diversified global business. We have also made significant pipeline progress. Five of our six anticipated Phase III readouts have shown positive results.
首先,我想介紹一下我們第二季業績的一些亮點。剔除印多爾的影響,我們實現了 3% 的資產剝離調整後營業收入成長,這主要得益於歐洲和大中華區的強勁成長。這些結果反映了我們的執行力和多元化全球業務的彈性。我們的管道也取得了重大進展。我們預期的六個第三階段讀數中有五個顯示出了積極的結果。
Most recently, this includes positive data from two ophthalmology programs targeting dim light disturbances and presbyopia, both of which address high unmet medical needs. With these readouts and our commercial assets, our Eye Care division remains well-positioned to become a more meaningful contributor to Viatris over the next few years.
最近,這包括兩個針對昏暗光線幹擾和老花眼的眼科計畫的積極數據,這兩個計畫都解決了尚未滿足的醫療需求。憑藉這些讀數和我們的商業資產,我們的眼科護理部門仍將在未來幾年內成為 Viatris 更有意義的貢獻者。
Earlier this year, we shared positive results for EFFEXOR for generalized anxiety disorder in Japan, XULANE low dose for contraception and our fast-acting formulation of meloxicam in acute pain. These achievements reinforce the strength of our pipeline and lay the foundation for our future.
今年早些時候,我們分享了 EFFEXOR 在日本治療廣泛性焦慮症、XULANE 低劑量避孕藥以及美洛昔康速效製劑治療急性疼痛的積極結果。這些成就增強了我們管道的實力,為我們的未來奠定了基礎。
Of particular note, the two Phase III studies for our meloxicam candidate demonstrated meaningful improvement in pain and reduced opioid use relative to placebo, a well-characterized and well-tolerated safety profile and superior pain control versus an opioid arm in post-hoc analyses. We expect to file by year-end and intend to commercialize this as a branded product, tapping into an $80 billion US acute pain market.
特別值得注意的是,我們針對美洛昔康候選藥物進行的兩項 III 期研究表明,與安慰劑相比,該藥物在疼痛方面有顯著改善,阿片類藥物的使用減少,其安全性良好且耐受性良好,並且在事後分析中與阿片類藥物組相比,其疼痛控制效果更佳。我們預計在年底前提交申請,並打算將其作為品牌產品商業化,進軍價值 800 億美元的美國急性疼痛市場。
For selatogrel and cenerimod, enrollment for the Phase III global programs for both assets is progressing well with first data readouts expected in 2026. We continue to view both of these as potentially transformational blockbuster treatments for patients in their respective therapeutic areas.
對於塞拉托格雷和塞尼莫德,這兩項資產的 III 期全球計畫的招募進展順利,預計將於 2026 年獲得首批數據。我們仍然認為這兩種藥物在各自的治療領域都具有為患者帶來變革性重大治療的效果。
For sotagliflozin, we received our first approval in the UAE earlier this year and filings are progressing well in other key countries around the world. As our pipeline advances, we remain committed to returning meaningful capital to shareholders. So far this year, we have returned more than $630 million, including $350 million in share repurchases. We continue to balance our focus on shareholder returns with strategic accretive in-market business development investments that could fuel future growth.
對於索格列淨,我們在今年稍早在阿聯酋獲得了首次批准,並且在全球其他主要國家的申請進展順利。隨著我們的產品線不斷進步,我們依然致力於為股東帶來豐厚的回報。今年迄今為止,我們已返還超過 6.3 億美元,其中包括 3.5 億美元的股票回購。我們將繼續在股東回報和能夠推動未來成長的策略性增值市場業務發展投資之間取得平衡。
We are also making strong progress on our enterprise-wide strategic review, evaluating all aspects of our business to ensure we're building a company that is both competitive today and prepared for the future. We plan to share an update of our progress during our Q3 earnings call in November.
我們在整個企業範圍內的策略評估也取得了長足的進展,評估了我們業務的各個方面,以確保我們正在建立一家既具有當今競爭力又為未來做好準備的公司。我們計劃在 11 月的第三季財報電話會議上分享我們的最新進展。
Turning to operational priorities. We remain focused on remediation efforts at our Indore facility, which are now nearly complete. Before the end of this month, we'll be asking the FDA for a meeting to discuss the progress of our remediation efforts and the potential timing for reinspection of the facility. At our Nashik facility, while FDA classification is still pending, all committed actions have been completed for some time. Encouragingly, we recently received FDA approval for darunavir tablets, an antiretroviral medicine made at our Nashik facility.
轉向營運重點。我們仍專注於印多爾工廠的修復工作,目前修復工作已接近尾聲。本月底之前,我們將要求 FDA 召開會議,討論我們的補救措施的進展以及重新檢查該設施的可能時間。在我們的納西克工廠,雖然 FDA 分類仍在等待中,但所有承諾的行動都已經完成了一段時間。令人鼓舞的是,我們最近獲得了 FDA 批准,可以在納西克工廠生產抗逆轉錄病毒藥物達蘆那韋片。
Finally, I'd like to touch on recent policy developments, including proposed US tariffs, which could impact the broader pharmaceutical landscape. Viatris serves approximately 1 billion patients worldwide each year. Our global supply chain is built to support patients where they live. Of the 37 manufacturing, distribution, R&D and packaging sites within our global network, 8 are located in the United States, which should position us well to navigate the impact of any future changes to trade policy.
最後,我想談談最近的政策發展,包括擬議的美國關稅,這可能會影響更廣泛的製藥業格局。Viatris 每年為全球約 10 億患者提供服務。我們的全球供應鏈旨在為患者提供居住地支援。在我們的全球網路內的 37 個製造、分銷、研發和包裝站點中,有 8 個位於美國,這使我們能夠很好地應對未來貿易政策變化的影響。
While we're monitoring tariff developments closely in order to assess potential impact on our business, based on the available information, we do not anticipate any material effect on our 2025 financial picture. We will continue to assess the impact of any potential tariffs on patient access and company financials, and we will provide updates accordingly.
雖然我們正在密切關注關稅發展以評估對我們業務的潛在影響,但根據現有信息,我們預計不會對我們 2025 年的財務狀況產生任何重大影響。我們將繼續評估任何潛在關稅對患者就醫和公司財務的影響,並提供相應的更新資訊。
We also continue to advocate strongly for thoughtful policymaking that protects access to medications, especially generics, which account for 90% of prescriptions filled in the United States and just 1% of the total health care spend. Currently, more than half of our US revenue is sourced domestically, and we are currently exploring ways to further leverage and expand our network.
我們也將繼續大力倡導制定周到的政策,保護人們獲得藥物的機會,尤其是仿製藥,仿製藥占美國處方藥的 90%,但僅佔醫療保健總支出的 1%。目前,我們在美國超過一半的收入來自國內,我們目前正在探索進一步利用和擴大我們的網路的方法。
With that said, based on the current pricing dynamics in the generics industry, we believe that moving additional manufacturing of noncomplex generics in the United States would be very difficult in the short term and not likely sustainable in the long term. However, our move towards more complex, innovative, higher-margin products does bring potential opportunity to further expand our domestic footprint.
話雖如此,基於仿製藥行業目前的定價動態,我們認為在美國轉移額外的非複雜仿製藥生產在短期內將非常困難,並且從長遠來看不太可能持續。然而,我們向更複雜、創新、利潤更高的產品的轉變確實為進一步擴大我們的國內影響力帶來了潛在的機會。
We are committed to evaluating all possible options. Ultimately, our goal is to ensure the right infrastructure is in place to serve patients in the United States and around the globe and maintain a sustainable business model. In closing, we have great momentum going into the second half of the year.
我們致力於評估所有可能的選擇。最終,我們的目標是確保建立適當的基礎設施來為美國和全球的患者提供服務,並維持可持續的商業模式。最後,我們進入下半年的勢頭強勁。
Given the strength of the results, we are reiterating our 2025 financial guidance ranges across all key metrics and currently expect to be in the top half of the range on revenue and adjusted EPS. We remain confident in the long-term trajectory of Viatris. The strength of our business, our maturing late-stage pipeline, disciplined capital allocation and strategic flexibility position us well for sustainable growth in '26 and beyond.
鑑於業績強勁,我們重申所有關鍵指標的 2025 年財務指導範圍,目前預計收入和調整後每股收益將處於該範圍的上半部分。我們對 Viatris 的長期發展仍然充滿信心。我們業務的實力、日趨成熟的後期產品線、嚴格的資本配置和策略靈活性使我們在 2026 年及以後能夠實現永續成長。
Now I'd like to turn it over to Philippe for more details on the pipeline.
現在我想把話題交給菲利普,讓他介紹更多有關管道的細節。
Philippe Martin - Chief R&D Officer
Philippe Martin - Chief R&D Officer
Thank you, Scott. We are proud of the significant progress our R&D team has made in advancing our pipeline of generics and late-stage novel and innovative assets. Starting with our Phase III programs, where five of our six anticipated Phase III readouts have shown positive results. We'll be presenting detailed results from our fast-acting meloxicam pivotal studies at the upcoming PANWeek Medical Congress in September.
謝謝你,斯科特。我們為研發團隊在推動仿製藥和後期新穎創新資產方面取得的重大進展感到自豪。從我們的第三階段專案開始,我們預期的六個第三階段讀數中有五個已經顯示出正面的結果。我們將在 9 月即將召開的 PANWeek 醫學大會上展示速效美洛昔康關鍵研究的詳細結果。
Five abstracts were accepted covering efficacy, safety and reduction in opioid use in two different surgery models as well as pharmacokinetics data. Overall, we remain highly enthusiastic about the potential of this asset as an acute pain, non-opioid treatment option with a benefit-risk profile that offers potential advantages over available treatment options and may lead to a significant reduction in opioid use.
五篇摘要被接受,涵蓋兩種不同手術模型中的鴉片類藥物的功效、安全性和減少使用以及藥物動力學數據。總體而言,我們仍然對該資產作為急性疼痛、非阿片類藥物治療選擇的潛力充滿熱情,其效益風險狀況比現有治療選擇具有潛在優勢,並可能顯著減少阿片類藥物的使用。
We are awaiting the FDA's response on the potential for an early submission and accelerated approval path given the strength of the data and the unmet public health need. We continue to target the submission of a new drug application by the end of this year. Turning to XULANE low dose. We remain on track to submit the NDA in the coming weeks and anticipate approval mid-next year.
鑑於數據的可靠性和未滿足的公共衛生需求,我們正在等待 FDA 對提前提交和加速審批途徑的可能性的回應。我們繼續以在今年年底前提交新藥申請為目標。轉向低劑量 XULANE。我們將在未來幾週內提交保密協議 (NDA),並預計明年年中獲批。
Our second contraceptive patch in development, a norelgestromin-only weekly patch is more than halfway through Phase III enrollment with data expected by early 2027. Now shifting to our ophthalmology programs. We are pleased with the positive results we recently shared from the second pivotal Phase III trial of MR-141 in presbyopia.
我們正在開發的第二種避孕貼片是僅含諾孕曲明的每週貼片,目前已完成 III 期招募的一半以上,預計將於 2027 年初獲得數據。現在轉向我們的眼科計畫。我們很高興看到最近分享的 MR-141 治療老花眼的第二項關鍵性 III 期試驗的積極成果。
The results reinforce our confidence in MR-141 and its benefit-risk profile as a potential noninvasive option to support the millions of patients impacted by this condition. We expect that this data will be presented at the American Society of Cataract and Refractive Surgery Annual Meeting in April 2026. We are targeting our application to the FDA in the second half of 2025.
研究結果增強了我們對 MR-141 及其效益風險狀況的信心,它是一種潛在的非侵入性選擇,可以為受這種疾病影響的數百萬患者提供支持。我們預計這些數據將在 2026 年 4 月的美國白內障和屈光手術學會年會上公佈。我們的目標是在 2025 年下半年向 FDA 提交申請。
In June, we also announced positive top-line results from our pivotal Phase III trial evaluating MR-142 in treating visual disturbances in low-light conditions following keratorefractive surgery. The study demonstrated significant functional improvement in these patients in their ability to drive and function under low-light conditions. Importantly, there are currently no FDA-approved options and the FDA has granted Fast Track designation, further emphasizing the unmet need.
6 月份,我們也公佈了關鍵的 III 期試驗的積極頂線結果,該試驗評估了 MR-142 在治療角膜屈光手術後弱光條件下的視覺障礙方面的作用。研究表明,這些患者的駕駛能力和在弱光條件下活動的能力有顯著改善。重要的是,目前尚無 FDA 批准的選項,且 FDA 已授予快速通道資格,進一步強調了未滿足的需求。
This data will be presented at the American Academy of Optometry in October 2025. We recently started our second pivotal study and expect to have results in the first half of 2026. The last of the ophthalmology results that we recently announced was our Phase III study of MR-139 for blepharitis. The study did not meet its primary endpoint of complete resolution of debris at week six.
數據將於 2025 年 10 月在美國驗光學會上公佈。我們最近開始了第二項關鍵研究,預計將在 2026 年上半年獲得結果。我們最近公佈的最後一項眼科研究結果是針對 MR-139 治療瞼緣炎的 III 期研究。該研究並未達到第六週碎片完全消散的主要終點。
Nominally significant change from baseline in debris at week six was observed, suggesting that this mechanism of action remains relevant for the treatment of blepharitis. MR-139 was generally safe and well tolerated. Additional work is ongoing to determine the appropriate next step for this program. Moving to selatogrel and cenerimod. We are pleased with our recruitment efforts for these two programs.
在第六週時觀察到碎片與基線相比的名義上顯著的變化,這表明這種作用機制對於瞼緣炎的治療仍然相關。MR-139 總體上是安全的並且耐受性良好。目前正在進行額外的工作來確定該計劃的下一步適當措施。轉向塞拉托格雷和西尼莫德。我們對這兩個項目的招募工作感到非常滿意。
For selatogrel, we have reached an enrollment rate of approximately 600 patients per month and anticipate we will reach approximately 1,000 patients per month by the end of the year and reach full enrollment in 2026. Turning to cenerimod in SLE. Enrollment is nearing completion, and we have started notifying sites and investigators accordingly.
對於塞拉格雷,我們已達到每月約 600 名患者的入組率,預計到今年年底將達到每月約 1,000 名患者,並在 2026 年實現全部入組。轉向 SLE 中的 cenerimod。招募工作即將完成,我們已經開始通知相關站點和研究人員。
We anticipate the first Phase III readout near the end of 2026, followed shortly thereafter by the second readout. In an effort to explore additional value this asset can bring to patients, we have received positive feedback from FDA and EMA on our proposed Phase III registration study in lupus nephritis and anticipate having our first patient enrolled by the end of the year.
我們預計第一階段第三季的讀數將在 2026 年底前公佈,隨後不久將公佈第二季的讀數。為了探索該資產可以為患者帶來的額外價值,我們已收到 FDA 和 EMA 對我們提出的狼瘡性腎炎 III 期註冊研究的積極反饋,並預計我們的第一位患者將於今年年底入組。
We are also making great progress with the remainder of our late-stage pipeline. Regarding sotagliflozin, we recently received our first approval in the UAE within a very short turnaround time. We have filed in Saudi Arabia and are expecting to file in Canada, Australia, New Zealand, Mexico and Southeast Asian countries before the end of the year.
我們的後期研發管線剩餘部分也取得了巨大進展。關於索格列淨,我們最近在很短的時間內獲得了阿聯酋的首次批准。我們已經在沙烏地阿拉伯提交了申請,並預計在今年年底前在加拿大、澳洲、紐西蘭、墨西哥和東南亞國家提交申請。
As we mentioned in our last call, the JNDA for EFFEXOR GAD is under review by the Japanese health authority and is progressing well. We anticipate approval in the first half of 2026. In addition, we've had two recent approvals in China for BREYNA and YUPELRI, demonstrating our capabilities in that market.
正如我們在上次電話會議中提到的那樣,EFFEXOR GAD 的 JNDA 正在接受日本衛生部門的審查,並且進展順利。我們預計將於 2026 年上半年獲得批准。此外,我們最近在中國獲得了 BREYNA 和 YUPELRI 的兩項批准,證明了我們在該市場的能力。
Finally, within our generic pipeline, all products scheduled for approval in Q2 were approved, except for iron sucrose. We believe our application is substantially through its scientific review and expect approval in the near future. The majority of our anticipated generics approvals are weighted towards the back half of the year. They remain largely on track, including for octreotide.
最後,在我們的仿製藥產品線中,除蔗糖鐵外,所有計劃於第二季度批准的產品均獲得了批准。我們相信我們的申請已基本通過科學審查,並預計在不久的將來獲得批准。我們預計大部分仿製藥的批准將集中在下半年。它們基本上仍在按計劃進行,包括奧曲肽。
Overall, we are pleased with the strong momentum we have across our pipeline and remain focused on delivering meaningful innovation for patients that address areas of significant unmet medical need.
總體而言,我們對整個產品線的強勁發展勢頭感到滿意,並將繼續專注於為患者提供有意義的創新,解決尚未滿足的重大醫療需求領域。
And now I'll turn the call to Doretta.
現在我將把電話轉給多蕾塔。
Theodora Mistras - Chief Financial Officer
Theodora Mistras - Chief Financial Officer
Thank you, Philippe, and good morning, everyone. We had another strong quarter and the underlying fundamentals of our base business of generics and established brands remain strong. Today, I'll walk you through the key highlights, the progress we've made against our capital allocation plan and our confidence in the outlook for the remainder of the year.
謝謝你,菲利普,大家早安。我們又度過了一個強勁的季度,仿製藥和知名品牌基礎業務的基本面依然強勁。今天,我將向大家介紹主要亮點、我們在資本配置計畫方面的進展以及我們對今年剩餘時間前景的信心。
Our second-quarter results came in ahead of our expectations, reflecting our well-diversified global business. Total revenues for the quarter were $3.58 billion, which were down approximately 2% versus the prior year. Excluding the Indore Impact of approximately $160 million, our operational revenue growth versus the prior year would have been approximately 3%.
我們第二季的業績超出了我們的預期,反映了我們多元化的全球業務。本季總營收為 35.8 億美元,較上年下降約 2%。不計約 1.6 億美元的印多爾影響,我們的營業收入較上年同期成長約 3%。
Now let me walk you through the commercial highlights for the quarter across our segments, which include the Indore Impact. In developed markets, we saw continued strength in brands, which helped to partially offset the Indore Impact. From a regional perspective, we continue to see consistent and durable growth from our European business, which grew approximately 2% this quarter, in line with our expectations.
現在,讓我向您介紹本季我們各部門的商業亮點,其中包括印多爾影響。在已開發市場,我們看到品牌持續走強,這有助於部分抵消印多爾的影響。從區域角度來看,我們的歐洲業務持續保持持續成長,本季成長約 2%,符合我們的預期。
In Europe, the brand's portfolio grew approximately 3%, led by EpiPen, CREON and Brufen in addition to positive contributions from key markets, including Italy. Generics' performance in Europe was flat year-over-year despite the Indore Impact and continues to benefit from the new product revenues in key markets such as France.
在歐洲,該品牌的產品組合成長了約 3%,其中 EpiPen、CREON 和 Brufen 成長最為顯著,此外還有來自義大利等主要市場的正面貢獻。儘管受到印多爾的影響,仿製藥在歐洲的業績與去年同期相比持平,並繼續受益於法國等主要市場的新產品收入。
As anticipated, our North American business decreased 11% versus the prior year, primarily as a result of the Indore Impact and competition on Wixela and other products. This was partially offset by continued growth in YUPELRI and BREYNA as well as contributions from new product revenues.
正如預期的那樣,我們的北美業務較上年下降了 11%,這主要是由於印多爾的影響以及 Wixela 和其他產品的競爭。這部分被 YUPELRI 和 BREYNA 的持續成長以及新產品收入的貢獻所抵銷。
In emerging markets, net sales exceeded expectations and increased approximately 1% versus the prior year. This was primarily driven by continued strength in Turkey and our emerging Asia region as well as stabilization in the Korean market. This performance helped to more than absorb the Indore Impact affecting our ARV generics business.
在新興市場,淨銷售額超出預期,較上年成長約1%。這主要得益於土耳其和新興亞洲地區的持續強勁表現以及韓國市場的穩定。這項業績不僅有助於緩解印多爾疫情對我們抗愛滋病毒仿製藥業務的影響。
In Jan, net sales decreased approximately 11%. Results were primarily driven by expected government price regulations and a change in reimbursement policy impacting off-patent brands in Japan and competition in Australia. This was partially offset by slight volume increases in our generics portfolio in Japan.
1月份,淨銷售額下降約11%。結果主要受到預期的政府價格監管和影響日本非專利品牌和澳洲競爭的報銷政策變化的影響。這被我們在日本的仿製藥產品組合的銷量小幅增長所部分抵消。
Lastly, we continue to see positive momentum in Greater China. Net sales exceeded expectations and grew 9%, driven by continued growth across our portfolio due to proactive patient choice. Net sales also benefited from the timing of customer purchasing patterns in the quarter, which we expect to moderate in the second half.
最後,我們繼續看到大中華區的正面勢頭。淨銷售額超出預期,成長 9%,這得益於患者主動選擇導致我們的產品組合持續成長。淨銷售額也受惠於本季客戶購買模式的時機,我們預計下半年這種購買模式將會緩和。
Moving to the remainder of the P&L. Adjusted gross margin of 56.6% in the quarter was in line with our expectations. As anticipated, margins were impacted versus the prior year due to the Indore Impact as well as price regulations in Japan. Operating expenses were down versus the prior year as a result of the planned cost-saving initiatives, which primarily benefited SG&A.
轉到損益表的剩餘部分。本季調整後的毛利率為 56.6%,符合我們的預期。正如預期的那樣,由於印多爾衝擊以及日本的價格管制,利潤率與前一年相比受到了影響。由於計劃中的成本節約舉措,營運費用較上年有所下降,這主要受益於銷售、一般及行政費用 (SG&A)。
Turning to free cash flow. We generated $167 million of cash in the quarter. Excluding the impact of transaction-related costs, we would have generated $241 million during the quarter. This was in line with our expectations and reflects the timing of semi-annual interest payments and working capital requirements in the quarter.
轉向自由現金流。本季我們產生了 1.67 億美元的現金。不計交易相關成本的影響,我們本季的營收為 2.41 億美元。這符合我們的預期,反映了本季半年利息支付和營運資金需求的時間。
Moving to capital allocation. We have repurchased shares totaling $350 million year-to-date. Including dividends paid, we have returned more than $630 million of capital this year to our shareholders. With this continued progress, we remain on track to deliver on our commitment of capital return this year.
轉向資本配置。今年迄今為止,我們已回購股票總額達 3.5 億美元。包括已支付的股息在內,我們今年已向股東返還了超過 6.3 億美元的資本。隨著這一持續進展,我們仍有望兌現今年的資本回報承諾。
Now a few comments on our outlook and phasing for the rest of the year. Based on the strong operational performance year-to-date and continued visibility of the anticipated Indore Impact, we are reaffirming all guidance ranges. Within total revenues, we expect to be in the top half of the guidance range as a result of positive operational momentum and the year-to-date benefit from foreign exchange.
現在就今年剩餘時間的展望和分階段做一些評論。基於今年迄今為止強勁的營運業績以及預期的印多爾影響的持續可見性,我們重申所有指導範圍。在總收入方面,由於積極的營運動能和年初至今的外匯收益,我們預計總收入將處於指導範圍的上半部。
We also expect adjusted EPS to be in the top half of the guidance range, primarily driven by share repurchases. Some of the pushes and pulls in this outlook include our continued expectation of divestiture-adjusted growth, excluding the Indore Impact of approximately 2% continued growth in Europe, Greater China and emerging markets regions and delays in the anticipated timing of approvals and launches of certain generic products, which could negatively impact our new product revenues this year.
我們也預期調整後的每股盈餘將處於指導範圍的上半部分,主要受股票回購的推動。這一前景中的一些推動因素包括我們繼續預期資產剝離調整後的成長,不包括印多爾影響,歐洲、大中華區和新興市場地區約 2% 的持續成長,以及某些仿製藥的預期批准和上市時間的延遲,這可能會對我們今年的新產品收入產生負面影響。
Lastly, we continue to monitor foreign exchange. If current rates were to hold for the remainder of the year, it could result in an additional 1% to 2% tailwind on total revenues. This could also result in adjusted EBITDA being in the top half of our guidance range. As a reminder, any potential foreign exchange tailwind benefiting total revenues would incorporate certain hedging program costs, which could reduce the benefit to adjusted EBITDA.
最後,我們持續監測外匯。如果今年剩餘時間內維持當前利率,則可能為總收入帶來 1% 至 2% 的額外成長。這也可能導致調整後的 EBITDA 處於我們指導範圍的上半部。提醒一下,任何可能有利於總收入的外匯順風都會包含一定的對沖計畫成本,這可能會減少調整後 EBITDA 的收益。
It is important to note that our guidance does not account for any potential impact related to industry tariffs. However, as Scott mentioned, we continue to assess the potential for future impact, but based on available information, we do not anticipate any material impact on our 2025 financial results. The following are a few points about the anticipated phasing for the rest of the year.
值得注意的是,我們的指導並未考慮與產業關稅相關的任何潛在影響。然而,正如斯科特所提到的,我們將繼續評估未來影響的可能性,但根據現有信息,我們預計不會對 2025 年的財務業績產生任何重大影響。以下是有關今年剩餘時間預計分階段實施的幾點說明。
Total revenues are still expected to be slightly higher in the second half at approximately 51%. This reflects the phasing of Indore, normal product seasonality and low to mid-single-digit growth in Greater China. Adjusted EBITDA and adjusted EPS are still expected to be higher in the second half. This incorporates the timing of spend and investments we are making to support our pipeline and upcoming launches.
預計下半年總收入仍將略高,約 51%。這反映了印多爾的分階段發展、正常的產品季節性以及大中華區的低至中等個位數增長。預計下半年調整後的 EBITDA 和調整後的 EPS 仍將更高。這包括我們為支持我們的產品線和即將推出的產品而進行的支出和投資的時間表。
Last, free cash flow is also expected to be higher in the second half and is expected to benefit from the timing of net working capital and disciplined inventory management. As you heard, our results for the quarter reflect strong performance. We remain encouraged by the underlying fundamentals of our global business growth and the success of our recent pipeline readouts. With these positive trends, we are building strong momentum for the rest of the year.
最後,預計下半年自由現金流也將更高,並有望受益於淨營運資本的時機和嚴格的庫存管理。正如您所聽到的,我們本季的業績表現強勁。我們仍然對全球業務成長的基本面和近期管道讀數的成功感到鼓舞。憑藉這些積極的趨勢,我們正在為今年剩餘的時間累積強勁勢頭。
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操作員,開始問答環節。
Operator
Operator
(Operator Instructions)
(操作員指示)
Matt Dellatorre, Goldman Sachs.
高盛的馬特‧德拉托雷 (Matt Dellatorre)。
Matt Dellatorre - Analyst
Matt Dellatorre - Analyst
Hey guys, good morning and thanks for the question and congrats on the progress. Maybe just on capital allocation in the context of the current split between buybacks and BD, how much of a priority is growth at this point? And what level of growth are you now aiming for as we think about full year '26 and beyond? And then in particular, what would make you more aggressive on the BD front?
嘿,大家早上好,感謝您的提問,並祝賀您的進展。也許只是在當前回購和 BD 之間的分歧背景下的資本配置,此時成長的優先順序有多高?當我們考慮 26 年全年及以後時,您現在瞄準的增長水平是怎樣的?那麼具體來說,什麼會讓您在 BD 方面更加積極主動呢?
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
Thank you very much, Matt. I'm not going to talk specifically about '26 and a number for growth. But relative to capital allocation, our plan has not changed, staying the same. We're evenly -- over a period of time, over the next three to five years, we expect to both give back through dividends and share buybacks. And also -- and I think very importantly, we also need to build a portfolio of growth assets, use our capital to do business development.
非常感謝,馬特。我不會具體談論『26』和成長數字。但對於資金配置,我們的計畫沒有改變,維持不變。我們預計在未來三到五年內,透過股利和股票回購來回報社會。而且—我認為非常重要的是,我們還需要建立一個成長資產組合,利用我們的資本進行業務發展。
And what we're really looking for here in terms of business development is strategic assets that are accretive and in market, growing assets to build a growth portfolio. So we're very focused on doing both, delivering capital, right, back to shareholders and also finding ways to build a growth pipeline. And I will say business development is just part of that growth pipeline going forward. Again, we're focused on strategic accretive in-market assets to bring into the portfolio.
就業務發展而言,我們真正尋找的是具有增值能力的策略資產,以及在市場上不斷成長的資產,以建立成長組合。因此,我們非常注重兩者,將資本回饋給股東,同時尋找建立成長管道的方法。我想說的是,業務發展只是未來成長管道的一部分。再次,我們專注於將具有策略性增值的市場資產納入投資組合。
But we also have, as we look at '26 and beyond, a lot of excitement around the launches that we have, positive data readouts that we had in '25 lead to launches, for example, EFFEXOR GAD in Japan, XULANE LO, which is a contraceptive product in the United States, fast-acting meloxicam, a couple of eye care readouts and launches in presbyopia and dim light also launching sotagliflozin in some key ex US markets.
但是,當我們展望 26 年及以後時,我們也對所推出的產品感到非常興奮,25 年獲得的積極數據讀數促成了一系列產品的推出,例如日本的 EFFEXOR GAD、美國的避孕產品 XULANE LO、速效美洛昔康、一些眼部護理讀數以及針對老花眼和光線的推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場推出了,還在美國以外的一些淨市場推出,還在美國以外的一些淨市場。
So we've got a lot of launches in '26. We've got some nice inflection points in terms of data readouts in '26 as well. Nefecon Japan, progestin-only patch and really importantly, cenerimod and selatogrel. So we feel good about the growth prospects. The base of the business is very solid. We've got a number of launches going into '26, and we've got capital to deploy to build a portfolio of growth assets.
因此我們在 26 年有很多發射任務。我們在 26 年的數據讀數方面也獲得了一些不錯的轉折點。Nefecon Japan,僅含孕激素的貼劑,以及非常重要的 cenerimod 和 selatogrel。因此我們對成長前景充滿信心。業務基礎非常牢固。我們在26年有多項新產品上市,而且我們有足夠的資金來建立成長資產組合。
Theodora Mistras - Chief Financial Officer
Theodora Mistras - Chief Financial Officer
And what, Matt, what I would also add is kind of we've talked about the base business growth, we continue to see visibility generally to generate low single digits from a revenue perspective for the base business. This year, for example, we're on track to deliver on that 2% operational growth ex Indore. And so the incremental investments and opportunities that Scott is mentioning would be additive to that baseline rate.
馬特,我還想補充一點,我們已經討論過基礎業務的成長,從收入角度來看,我們仍然普遍認為基礎業務的成長將保持在較低的個位數。例如,今年我們預計將實現印多爾以外地區 2% 的營運成長。因此,斯科特提到的增量投資和機會將會加到該基準利率中。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
Absolutely. And we're looking for not just growth in one year. We're looking to put a program together to have sustainable long-term revenue and EBITDA growth over time.
絕對地。我們所追求的不僅僅是一年內的成長。我們希望制定一個計劃,以實現可持續的長期收入和 EBITDA 成長。
Operator
Operator
Umer Raffat, Evercore.
烏默·拉法特(Umer Raffat),Evercore。
Unidentified Participant
Unidentified Participant
Good morning, guys. This is J.P. in lieu of Umer. Congrats on a strong quarter. So going back to tariffs, you mentioned you have flexibility for next year. How are you thinking on the proportion of the risk India versus EU? It looks like we're going to have two different kind of tariffs for each region.
大家早安。這是代替 Umer 的 J.P.。恭喜本季業績強勁。回到關稅問題,您提到明年有彈性。您認為印度與歐盟的風險比例如何?看起來我們將針對每個地區實施兩種不同的關稅。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
So yes, thank you for the question (inaudible). So it's not clear to us at this point in time whether tariffs will be placed on pharmaceuticals. If they are, will it be placed on generic products at this point, there are no tariffs? And so we're monitoring the situation very, very, very carefully.
是的,謝謝你的提問(聽不清楚)。因此,目前我們還不清楚是否會對藥品徵收關稅。如果是的話,目前這種措施是否會應用於仿製藥,因為還沒有關稅?因此,我們正在非常非常仔細地監視局勢。
About half our products in the United States from a revenue perspective are manufactured in the United States. We do have some exposure in EU and India. I would say India is about 10% of our revenue, a significant volume in terms of product. It tends to be low-margin OSD-type products coming out of India, but it's 10%. So as the situation evolves, as we get more clarity on how tariffs may affect the overall industry, the generic industry, et cetera, we model all kinds of things.
從收入角度來看,我們在美國約有一半的產品是在美國製造的。我們確實在歐盟和印度有一些業務。我想說印度約占我們收入的 10%,就產品而言,這是一個相當大的份額。它往往是來自印度的低利潤OSD型產品,但利潤率為10%。因此,隨著情況的發展,隨著我們更清楚地了解關稅如何影響整個產業、仿製藥產業等,我們會對各種事物進行建模。
But until we have clarity on that, it's very difficult to think of an impact. And again, I think both Doretta and I in our prepared remarks, mentioned that regardless of tariffs, how it evolves during the course of this year, we've put mitigations in place. We do not see any material financial impact in '25. And we'll know more about '26 and beyond once we get some specifics.
但在我們弄清楚這一點之前,很難想像它會產生影響。而且,我認為多雷塔和我都在準備好的發言中提到,無論關稅如何,也無論今年關稅如何演變,我們都已經採取了緩解措施。我們認為 25 年不會產生任何重大的財務影響。一旦我們獲得一些具體信息,我們就會對 26 年及以後的情況有更多了解。
Operator
Operator
David Amsellem, Piper Sandler. And David, is it possible that your phone is on mute? All right. We'll move on to Ash Verma, UBS.
大衛·阿姆塞勒姆、派珀·桑德勒。大衛,你的手機是不是靜音了?好的。我們接下來討論瑞銀的 Ash Verma。
Ashwani Verma - Analyst
Ashwani Verma - Analyst
So I wanted to ask about the China business. It seems particularly strong this quarter. I know you called out some purchasing patterns. What's the growth excluding that? And then just more broadly, there's been a lot of biopharma deal-making activity in the region, increasingly. How much of that is a focus for you for your BD efforts?
所以我想詢問一下中國業務的情況。本季表現尤其強勁。我知道您提到了一些購買模式。除此之外,成長是多少?更廣泛地說,該地區的生物製藥交易活動日益增多。您在 BD 工作中有多大程度上註重這一點?
And then the second thing, on the enterprise-wide strategic review, still waiting to hear a little bit of clarity in terms of what is the scope of activities that you want to showcase and what's the timeline line for that? Is there any potential cost optimization that can be a part of that exercise? Or should we not expect that?
然後第二件事,關於企業範圍的策略評估,仍然在等待聽到一些明確的訊息,即您想要展示的活動範圍是什麼,以及時間表是什麼?是否有任何潛在的成本優化可以成為該活動的一部分?或者我們不應該期待這一點?
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
So let me maybe address that part first, and then we'll go into China. The enterprise strategic review, we're well-engaged in it. We're actively looking at every part of the business. And I think the reason we're doing this now is I think there's -- it's a good time. We've done four divestitures.
因此,我先來談談這個部分,然後我們再討論中國。企業策略評估,我們積極參與。我們正在積極關注業務的每個部分。我認為我們現在這樣做的原因是——這是一個好時機。我們已經進行了四次資產剝離。
The company is a product of a merger of two different companies, and we're evolving our business model to sort of move up the value chain and get involved in more complex and innovative products. And so now is a good time to really take a look at things. Do we have the right people in the right places to be effective?
該公司是由兩家不同的公司合併而成,我們正在改進我們的商業模式,以提升價值鏈並涉足更複雜和創新的產品。因此,現在是真正審視事物的好時機。我們是否在合適的職位上安排了合適的人才,以發揮其效力?
This is sort of about making sure the company is as effective and efficient as possible, delivering the business today and delivering the business for the future. I believe there will be significant cost savings that come out of it as well, which will benefit the company. And we don't -- I don't want to get ahead of myself.
這是為了確保公司盡可能有效和有效率地開展當前業務並開展未來業務。我相信這也會節省大量成本,這對公司有利。我們不會——我不想超越自己。
We're not through that full process yet. But in Q3, we have an expectation, my goal to be able to provide significant granularity relative to that program by the time we get to the Q3 call.
我們尚未完成整個過程。但在第三季度,我們有一個期望,我的目標是能夠在我們進入第三季度電話會議時提供與該計劃相關的重要細節。
Corinne Le Goff - Chief Commercial Officer
Corinne Le Goff - Chief Commercial Officer
So Ash, let me address your China question. So in Q2, China grew 9% operational growth. And that's really the result of our diversified commercial model, which is across e-commerce, retail and private hospitals. And we also benefited in the quarter from the timing of customer buying patterns, and that's what Doretta mentioned in her prepared remarks.
那麼,阿什,讓我來回答一下你的中國問題。因此,第二季中國營運成長率達 9%。這確實是我們多元化商業模式的結果,涵蓋電子商務、零售和私人醫院。本季我們也受惠於客戶購買模式的時機,這就是多雷塔在她準備好的發言中提到的。
Now for the rest of the year, we expect the growth to moderate more to the low to middle-digit growth. But what we're seeing is the consistent demand for our iconic brands that have very strong brand equity and notably the brands that offer patients really the trust that they need. So the brands that are sensitive to proactive patient demands. So the overlook is positive for China for the rest of the year. And as a reminder, about 95% of all our brands went through the BBP process already. So that gives us some certainty on the outlook in the region.
對於今年剩餘時間,我們預計成長將進一步放緩至低位數至中位數成長。但我們看到的是,市場對我們標誌性品牌的需求持續存在,這些品牌擁有非常強大的品牌資產,尤其是那些能夠真正給予患者所需信任的品牌。因此,這些品牌對患者的主動需求非常敏感。因此,對中國今年剩餘時間的前景看好。提醒一下,我們大約 95% 的品牌已經經歷了 BBP 流程。這讓我們對該地區的前景有了一定的確定性。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
And just a couple of comments on the China business for me. I think overall, the market has progressed very well, both in the base side and the innovative side in China. Very, very proud of the team we have there and how well they're executing. I think we see some really good momentum in our China business, which we're very pleased about.
我對中國業務只想發表幾點評論。我認為整體而言,中國市場無論是在基礎方面還是在創新方面都進展得非常好。我對我們的團隊以及他們的出色表現感到非常自豪。我認為我們的中國業務呈現出了非常好的發展勢頭,我們對此感到非常高興。
And relative to your BD comment, yes, there's a lot of companies out there from a sort of biotech, small pharma perspective. There's lots of discussions going on. China seems to be very active in that so far, not only sort of products in China for China, but China for the rest of the world. So lots of discussions, lots of interesting things happen in China BioWorld for sure.
相對於您的 BD 評論,是的,從生物技術、小型製藥的角度來看,有很多公司。有很多討論正在進行。到目前為止,中國似乎在這方面非常活躍,不僅在中國為中國提供各種產品,而且中國也為世界其他地區提供產品。因此,中國生物世界肯定會發生很多討論和很多有趣的事情。
Operator
Operator
David Amsellem, Piper Sandler.
大衛·阿姆塞勒姆、派珀·桑德勒。
David Amsellem - Analyst
David Amsellem - Analyst
Thanks. I'm sorry about that, and thanks for accommodating me. So a couple for me. Number one, and sorry if I missed this, can you just talk about the contribution from new products in developed markets this year, if you can quantify that? And is that tracking to your stated expectation? Then secondly, looking beyond Indore, can you just talk about inspections at the other facilities that you've called out in the past? I think there was Nashik as well.
謝謝。對此我感到很抱歉,感謝您的包容。對我來說這是一對。第一,如果我錯過了,很抱歉,您能否談談今年已開發市場新產品的貢獻,您是否可以量化這一點?這符合您所期望的嗎?其次,除了印多爾之外,您能否談談您過去對其他設施的檢查情況?我認為納西克也是一樣。
But just wanted any color there to the extent there's anything new to add. And then lastly, on meloxicam, can you just talk about the commercial infrastructure you're going to be putting in place here? Is this going to be an office-based product, a hospital product, both? I mean there's some promotion intensity here. So how are you thinking about the overall level of investment given that you've got a filing coming up for that product?
但我只是希望那裡有顏色,以便可以添加新內容。最後,關於美洛昔康,您能談談您將在這裡建立的商業基礎設施嗎?這會是辦公室產品、醫院產品,還是兩者兼具?我的意思是這裡有一些促銷力道。那麼,考慮到您即將提交該產品的申請,您如何考慮整體投資水準?
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
Please, Doretta, why don't you take the first part?
拜託,多蕾塔,為什麼不選擇第一部呢?
Theodora Mistras - Chief Financial Officer
Theodora Mistras - Chief Financial Officer
Why don't I start on the new product revenue. So I would just say, generally, to your point, David, on any given year, our expectation is to generate about $450 million to $550 million of new product revenue. I don't want to get into mix shifts between developed markets and emerging markets. We really view it as a portfolio in terms of the total revenue.
我為什麼不開始研究新產品的收入呢?因此,我只想說,一般來說,正如你所說,大衛,在任何一年,我們的預期是產生約 4.5 億至 5.5 億美元的新產品收入。我不想陷入已開發市場和新興市場之間的混合轉變。從總收入的角度來看,我們確實將其視為一個投資組合。
This year, and you heard in our commentary, we did assume that new product revenue would be back half weighted just based on our estimated approval and launch timing of certain generics. And ultimately, that will be an impact of any potential delays of timing of approvals such as, for example, kind of iron sucralose and others could negatively impact our new product revenues.
今年,正如您在我們的評論中所聽到的,我們確實假設新產品收入將根據我們對某些仿製藥的批准和上市時間的估計而加權一半。最終,任何潛在的審批時間延遲都會產生影響,例如三氯蔗糖鐵等都可能對我們的新產品收入產生負面影響。
But overall, I would just say we've taken all of these pushes and pulls into account with respect to our guidance commentary and our kind of total revenue range, and we're going to continue to monitor things as we move through the back half of the year.
但總的來說,我只想說,我們在製定指導意見和總收入範圍時已經考慮了所有這些推動和拉動因素,並且我們將在今年下半年繼續監控事態發展。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
And I'll send it over to Corinne to talk about the meloxicam commercial strategy.
我會把它寄給 Corinne,讓她討論美洛昔康的商業策略。
Corinne Le Goff - Chief Commercial Officer
Corinne Le Goff - Chief Commercial Officer
David, so as you know, we are very bullish about our fast-acting meloxicam. This is the moderate to severe acute pain market is large. It's an $80 billion opportunity in the US. We are in the midst of our launch planning and it's progressing very nice. We are currently focusing on doing market research for positioning.
大衛,如你所知,我們對我們的速效美洛昔康非常看好。這是中度至重度急性疼痛市場很大。這對美國來說是一個價值 800 億美元的商機。我們目前正在進行發布規劃,進展非常順利。我們目前正專注於進行市場定位研究。
We are doing our pricing and payer research. So it's a bit too early for us at the moment to give you more details on how we're going to go about launching this product, although we have some ideas. But what I can tell you is that it's going to be a large opportunity for Viatris going forward. And we are very much looking forward to filing this asset before the end of the year and launching this product potentially next year.
我們正在進行定價和付款人研究。因此,雖然我們有一些想法,但現在向您提供有關如何推出產品的更多細節還為時過早。但我可以告訴你的是,這對 Viatris 未來發展來說將是一個巨大的機會。我們非常期待在今年年底前提交這項資產並可能在明年推出該產品。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
Yes, we see that as a very significant opportunity for us going forward. It will be the right time and place to go through full commercial strategy structures. Do we do partnerships, do we not? Exactly how do we approach the market and those sorts of things? But we've got some work to do to get ready for that.
是的,我們認為這對我們未來發展來說是一個非常重要的機會。現在正是全面檢視商業策略結構的最佳時機和地點。我們建立合作關係了嗎?我們究竟該如何對待市場和諸如此類的事情?但為了做好準備,我們還需要做一些工作。
We just got the data again in May, and we've been doing very, very -- a lot of work, very hard work, head down, figuring out what our strategies are. And there'll be the right time when we can sort of unveil all of that to you in a good way. But again, we think this is going to be a very significant part of our portfolio going forward. In terms of the operations update, we are approximately 80% or so remediated in our Indore facility.
我們剛剛在五月再次獲得了數據,我們一直在埋頭苦幹,做著非常非常多的工作,非常艱苦的工作,弄清楚我們的策略是什麼。到了適當的時候,我們就會以一種好的方式向你們揭示這一切。但我們再次認為,這將成為我們未來投資組合中非常重要的一部分。就營運更新而言,我們在印多爾工廠的修復工作已完成約 80%。
We've got a good line of sight on completing all the remaining items. In the next couple of days, we're going to ask the FDA to meeting -- for a meeting to discuss not only how the remediation has been going, but also talk about timing for reinspection of that facility. We'll have more clarity on the timelines of reinspection and things once we do have that meeting, which will happen this month.
我們已經基本完成了所有剩餘的項目。在接下來的幾天裡,我們將要求 FDA 召開會議——不僅討論補救措施的進展情況,還要討論重新檢查該設施的時間。一旦我們召開會議(將於本月舉行),我們將對重新檢查的時間表和事項有更清晰的了解。
The request will go in this month for that meeting. In terms of Nashik, I think it was an encouraging sign that the FDA approved the product that is manufactured in Nashik. Having said that, the FDA classification is still pending. We've completed all the actions for some time ago. And again, getting that approval of the product manufactured in Nashik, I think, is a positive sign there. So we're making a lot of progress on the operations front.
該會議的請求將於本月提出。就納西克而言,我認為 FDA 批准在納西克生產的產品是一個令人鼓舞的跡象。話雖如此,FDA 分類仍有待確定。我們前段時間已經完成了所有行動。我認為,獲得納西克生產產品的批准是一個積極的信號。因此我們在營運方面取得了巨大進展。
Operator
Operator
Jason Gerberry, Bank of America.
美國銀行的 Jason Gerberry。
Bhavin Patel - Analyst
Bhavin Patel - Analyst
This is Bhavin Patel on for Jason. A couple of questions from us. First, on the pipeline for MR-141. How do you see this drug positioned relative to other newer eye drop therapies for the improvement of near vision? Do you expect a similar label indication?
我是 Bhavin Patel,取代 Jason。我們有幾個問題。首先,關於 MR-141 的管道。與其他改善近距離視力的新型眼藥水療法相比,您如何看待這種藥物的定位?您是否期望有類似的標籤指示?
And what's the strategy to build this market where AbbVie was unable to with annuity? And then my second question is with regards to gross margins. So we saw a sequential improvement from 1Q's 56% to 2Q's 58%. Maybe if you could provide some more color on the key drivers of this improvement. Is it from the mix shift from new product launches? Or are cost savings initiatives and supply chain efficiencies starting to materialize earlier than expected?
那麼,AbbVie 用年金無法開拓的這個市場該如何開拓呢?我的第二個問題是關於毛利率的。因此,我們看到了從第一季的 56% 到第二季的 58% 的連續改善。也許您可以更詳細地說明這項改進的關鍵驅動因素。這是由於新產品發布帶來的產品組合變化嗎?或者成本節約措施和供應鏈效率是否比預期更早開始實現?
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
So for the eye care question, I'm going to ask Philippe and Corinne to address that first.
因此,對於眼部護理問題,我將首先請 Philippe 和 Corinne 來解答。
Philippe Martin - Chief R&D Officer
Philippe Martin - Chief R&D Officer
Thank you. Yes. So let me start, and then I'll ask Corinne to add. So as you know, MR-141 offers a different mechanism of action than the approved myiotic products, including the recently approved one. And we believe that this will lead to important differences in safety profile between these assets.
謝謝。是的。那麼就讓我開始吧,然後我會請 Corinne 補充。因此,如您所知,MR-141 的作用機制與已批准的肌鬆產品(包括最近批准的肌鬆產品)不同。我們相信這將導致這些資產的安全性出現重大差異。
The myiotic effect on ciliary body leads to significant risk, blurry vision, headaches and risk of retinal detachment or tear. So we don't expect that kind of labeling for MR-141 based on the mechanism of action and the data that we generated in Phase III.
睫狀體上的縮瞳作用會導致嚴重的風險,包括視力模糊、頭痛以及視網膜脫落或撕裂的風險。因此,根據作用機制和我們在第三階段產生的數據,我們並不期望 MR-141 有這樣的標籤。
Now importantly, you will remember that this asset was designed to reduce the pupil size to no less than 2 millimeters, which if you go below 2 millimeters, which is the case with the myotic asset, you will -- that will lead to reduced vision in dim light setting. So also a significant difference between these two assets. So we'll present our data in a medical meeting very soon in April of 2026 and anticipate that we'll be able to file by the second half of 2025.
現在重要的是,你會記得,該資產的設計目的是將瞳孔尺寸減小到不小於 2 毫米,如果低於 2 毫米(這就是縮瞳資產的情況),你就會在昏暗的燈光下視力下降。因此這兩種資產之間也存在顯著差異。因此,我們很快就會在 2026 年 4 月的醫學會議上展示我們的數據,並預計我們將能夠在 2025 年下半年提交申請。
I can turn it to Corinne.
我可以把它交給 Corinne。
Corinne Le Goff - Chief Commercial Officer
Corinne Le Goff - Chief Commercial Officer
So to your question about how this market is going to evolve. It's a very large addressable market in the US .We have about 128 million patients who suffer from presbyopia. And we really believe that this market is opening up to therapeutics. We now have 2 approved agents in this market.
那麼,關於這個市場將如何發展的問題。這是美國一個非常大的潛在市場我們有大約1.28億老花眼患者。我們確實相信這個市場正在向治療學開放。目前我們在這個市場有 2 個認可代理商。
As Philippe mentioned, we believe that our asset, phentolamine, can play a very important role in addressing the unmet needs in this market and this very unique patient population. It's a different mechanism of action. We expect a very different efficacy and safety profile than the assets that are currently approved. And we think it's a great opportunity as we build and continue to build our eye care business. As you know, we have already an eye care division with capabilities in the US, and we're looking forward to having phentolamine contribute to the revenues of the eye care business going forward.
正如菲利普所提到的,我們相信我們的資產酚妥拉明可以在滿足這個市場和這個非常獨特的患者群體的未滿足需求方面發揮非常重要的作用。這是一種不同的作用機轉。我們預期其功效和安全性與目前核准的資產有很大不同。我們認為,對於我們建立並持續發展眼科保健業務來說,這是一個很好的機會。如您所知,我們在美國已經擁有一個具有實力的眼科護理部門,我們期待酚妥拉明能夠為未來的眼科護理業務收入做出貢獻。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
I'll just make a comment on eye care business in general. We've had some significant management changes. We changed the footprint and the approach a little bit. I think we have now in place a world-class team of people who have developed and marketed and sold blockbuster products, innovative products that really understand the marketplace very, very well.
我只想對眼保健業務整體發表一下評論。我們的管理發生了一些重大變化。我們稍微改變了足跡和方法。我認為我們現在已經擁有一支世界級的團隊,他們開發、行銷和銷售重磅產品,這些創新產品非常了解市場。
And again, some real-world-class talent in that group. We -- I think as I take a look at it with the world-class group, the people that we have in place, the changes that we made, two positive readouts recently for, again, presbyopia and dim light, I look for the Eye Care division to become a significant contributor, a much more significant contributor than it is today to our overall business.
再說一次,這個群體中有一些真正世界級的人才。我們——我認為,當我與世界一流的團隊一起審視它時,我們擁有的人才、我們所做的改變,以及最近針對老花眼和昏暗光線的兩個積極讀數,我希望眼部護理部門成為一個重要的貢獻者,對我們的整體業務做出比現在更重要的貢獻。
So we're putting the efforts in there, and hopefully, we'll see some good returns. And again, I expect more positive contributions from the Eye Care division as we move forward. And I'll turn it over to Doretta to answer the gross margin question.
因此,我們正在努力,希望能夠看到良好的回報。我再次期待,隨著我們不斷前進,眼部護理部門能夠做出更多積極的貢獻。我將把這個問題交給多雷塔來回答。
Theodora Mistras - Chief Financial Officer
Theodora Mistras - Chief Financial Officer
Great. So with respect to gross margins, gross margins came in for the quarter in line with our expectations. The primary driver of the step-up versus Q1 was a couple fold. One, we did see kind of slightly less mix shift impact from Indore specifically as it relates to some of the penalties.
偉大的。因此,就毛利率而言,本季的毛利率符合我們的預期。與第一季相比,成長的主要驅動因素有幾個面向。首先,我們確實看到印多爾的混合轉變影響略有減少,特別是與一些處罰有關。
And then we also saw some improved products and segments that impacted the quarter. But generally, it was in line with our expectations. As we look in the second half, however, I would also say that from a second half perspective, I would say gross margins, we expect to be consistent from a phasing perspective as what we saw in the first half.
我們也看到了一些對本季產生影響的改進產品和細分市場。但總體來說,它符合我們的預期。然而,當我們展望下半年時,我還要說,從下半年的角度來看,我們預期毛利率將從分階段的角度與上半年保持一致。
Operator
Operator
And ladies and gentlemen, with that, we'll be concluding today's question-and-answer session. I'd like to turn the call back over to Scott Smith for closing remarks.
女士們、先生們,今天的問答環節就到此結束。我想將電話轉回給斯科特史密斯 (Scott Smith) 來做最後發言。
Scott Smith - Chief Executive Officer, Director
Scott Smith - Chief Executive Officer, Director
Thank you very much, and thank you to everybody on the call. 2025 is shaping up to be an important year for Viatris. We are executing with purpose and precision, driving our business, advancing a high-potential pipeline and returning meaningful value to shareholders.
非常感謝,也感謝電話裡的每一個人。 2025 年對 Viatris 來說將是重要的一年。我們目標明確、精準執行,推動業務發展,推動高潛力人才儲備,為股東帶來有意義的價值。
At the same time, we're planning for long-term success. I'd like to add my sincere thank you to the more than 30,000 Viatris employees around the world for delivering an exceptional quarter in a challenging global environment. Thank you, everybody.
同時,我們也在為長期成功做規劃。我要向全球 30,000 多名 Viatris 員工表示誠摯的感謝,感謝他們在充滿挑戰的全球環境中創造了卓越的季度業績。謝謝大家。
Operator
Operator
Ladies and gentlemen, that does conclude today's conference call and presentation. We 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到此結束。感謝您的加入。現在您可以斷開線路了。