Viatris Inc (VTRS) 2025 Q1 法說會逐字稿

Good morning, everyone, and welcome to the Viatris Q1 2025 earnings call. (Operator Instructions) Please also note, today's event is being recorded.

大家早安，歡迎參加 Viatris 2025 年第一季財報電話會議。 （操作員指示）另請注意，今天的活動正在被記錄。

At this time, I'd like to turn the floor over to Bill Szablewski, Head of Capital Markets. Please go ahead.

現在，我想把發言權交給資本市場主管 Bill Szablewski。請繼續。

Good morning, everyone. Welcome to our Q1 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.

大家早安。歡迎參加我們的 2025 年第一季財報電話會議。今天和我們在一起的是我們的執行長 Scott Smith；首席財務官，Doretta Mistras；首席研發官 Philippe Martin；以及首席商務官 Corinne Le Goff。

During today's call, we 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.

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 proportion of 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 or reported results to our expectations, we are making comparisons to our 2025 financial guidance.

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 年期間完成的剝離所產生的結果比例。我們可以將這些稱為基於操作的變化。當將我們的 2025 年實際或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。

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

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

Good morning, everyone. 2025 is off to a good start as we continue to focus on executing on our strategic priorities. Highlights include, Q1 operational performance in line with expectations; significant pipeline progress including three positive Phase 3 data readouts; returned approximately $450 million in capital to shareholders with approximately $300 million of that through share repurchases; continued remediation of our Indore facility; and on track to request re-inspection mid-year, significant progress on our enterprise wide strategic review, working to set the organization up for future growth.

大家早安。 2025 年開局良好，我們將繼續專注於執行我們的策略重點。亮點包括，第一季度營運業績符合預期；管道取得重大進展，包括三份積極的第三階段數據讀數；向股東返還約 4.5 億美元資本，其中約 3 億美元通過股票回購實現；繼續修復我們的印多爾工廠；並預計在年中要求重新檢查，我們企業範圍的戰略審查取得了重大發展進展，為組織未來的發展做好準備。

In Q1, we delivered $3.3 billion in total revenues, down 2% on a divestiture adjusted operational basis, driven primarily by the impact of Indore. We were particularly pleased with our strong execution and growth in Europe and China this quarter. So far this year, we've made tremendous progress in advancing our pipeline, and Philippe will provide additional details shortly.

第一季度，我們的總收入為 33 億美元，以資產剝離調整後的營運基礎計算下降了 2%，這主要受到印多爾的影響。我們對本季在歐洲和中國的強勁執行力和成長感到特別滿意。今年到目前為止，我們在推進產品線方面取得了巨大進展，Philippe 很快就會提供更多細節。

This morning, we announced positive data for Phase 3 studies of our novel fast-acting meloxicam in moderate to severe acute pain. This is a significant advancement for Viatris in an area of high unmet medical need. We believe there's a tremendous demand for more non-opioid treatment options for patients in moderate severe acute pain. We look very much forward to progressing this treatment for registrational filings in 2025.

今天上午，我們發表了新型速效美洛昔康治療中度至重度急性疼痛的 3 期研究的積極數據。這對於 Viatris 在醫療需求尚未滿足的領域而言是一個重大進步。我們相信，中度重度急性疼痛患者對更多非鴉片類藥物治療方案的需求龐大。我們非常期待在 2025 年推進此項註冊申請的處理。

Additionally in the quarter, we received positive data for XULANE LO, a transdermal patch that is being developed to offer women a low-dose estrogen combination birth control option. We plan to submit our NDA in the second half of this year.

此外，本季我們收到了有關 XULANE LO 的積極數據，這是一種透皮貼劑，正在開發中，為女性提供低劑量雌激素組合避孕選擇。我們計劃在今年下半年提交保密協議 (NDA)。

Earlier this quarter, we received positive results from the Phase 3 open-label long-term extension study for EFFEXOR required for approval in Japan where we filed an sNDA for EFFEXOR for the treatment of generalized anxiety disorder, an indication for which no other treatment option is currently available or approved in Japan. To date, we've received three of the six Phase 3 data readouts that we are expecting this year. Importantly, all other studies remain on track to read out later this year.

本季度早些時候，我們獲得了日本批准所需的 EFFEXOR 第 3 階段開放標籤長期擴展研究的積極結果，我們在該研究中提交了 EFFEXOR 的 sNDA，用於治療廣泛性焦慮症，而對於這種症狀，目前日本尚無其他可用或批准的治療選擇。到目前為止，我們已經收到了今年預計將收到的六個第三階段數據讀數中的三個。重要的是，所有其他研究仍將按計劃在今年稍後公佈。

In addition, we continue to make great progress on Selatogrel, Cenerimod and Sotagliflozin, and these innovative assets remain on track for important data readouts beginning in 2026. As previously discussed, in Q1, we entered into agreement with our partners from Idorsia that allows us even greater control over the Selatogrel and Cenerimod development programs and expands our geographic ownership of Cenerimod.

此外，我們在 Selatogrel、Cenerimod 和 Sotagliflozin 方面繼續取得重大進展，這些創新資產仍有望在 2026 年開始的重要數據讀取中取得進展。如前所述，在第一季度，我們與 Idorsia 的合作夥伴達成了協議，這使我們對 Selatogrel 和 Cenerimod 開發計劃有了更大的控制權，並擴大了我們對 Cenerimod 的地理所有權。

From a capital allocation perspective, during this period of significant market and policy unpredictability, we have prioritized returning capital to shareholders. To date, we have returned approximately $450 million in capital to shareholders with approximately $300 million of that from share repurchases and $143 million from dividends.

從資本配置角度來看，在市場和政策發生較大變化的時期，我們優先考慮向股東返還資本。迄今為止，我們已向股東返還了約 4.5 億美元的資本，其中約 3 億美元來自股票回購，1.43 億美元來自股息。

We are reaffirming our commitment to prioritize return of capital to shareholders in 2025. We continue to make progress on our remediation at our Indore facility and have engaged third-party subject matter experts to assist in this task. As stated in February, we expect to submit a request for re-inspection mid-year.

我們重申我們的承諾，在 2025 年優先向股東返還資本。我們在印多爾工廠的修復工作持續取得進展，並聘請了第三方主題專家協助完成這項任務。正如二月所述，我們預計將在年中提交重新檢查的申請。

We have also kicked off our enterprise-wide strategic review and are taking the opportunity to look at our business holistically. We will do this while ensuring we continue to protect and grow the base business and further develop our innovative capabilities. This is an opportunity for us to look at streamlining costs globally to reflect our smaller and more simplified post-divestiture footprint and ensure we are ready for the next stage of sustainable revenue and earnings growth. Considering our performance in the first quarter, we are reaffirming our outlook for the year.

我們也啟動了全企業策略審查，並藉此機會全面審視我們的業務。我們將在確保繼續保護和發展基礎業務並進一步發展創新能力的同時做到這一點。這是我們的一個機會，讓我們在全球範圍內精簡成本，以反映我們更小、更簡化的剝離後足跡，並確保我們為下一階段的可持續收入和盈利增長做好準備。考慮到我們第一季的表現，我們重申對今年的展望。

Turning to the current discussions around tariffs at Viatris, we take seriously our mission to empower people worldwide to live healthier at every stage of life. In fact, we are very proud that we serve approximately 1 billion patients worldwide each year. While tariffs on pharmaceuticals, if enacted, could have a negative financial impact on the organization, we are also concerned about the potential for additional supply shortages and disruptions that could have a significant impact on the ability for Americans and indeed patients around the globe to access the medicines they need.

談到目前關於 Viatris 關稅的討論，我們認真對待我們的使命，讓全世界的人們能夠在人生的每個階段都過著更健康的生活。事實上，我們非常自豪每年為全球約 10 億名患者提供服務。如果對藥品徵收關稅，可能會對組織產生負面的財務影響，但我們也擔心可能出現額外的供應短缺和中斷，這可能會對美國人乃至全球患者獲得所需藥品的能力產生重大影響。

We currently commercialize our products in 165 countries and have 36 manufacturing, R&D, and packaging sites around the globe. Eight of these facilities are in the United States. We have deep expertise in managing a global supply network, and we are continually taking steps to be nimble and responsive to any opportunities or challenges that lie ahead.

目前，我們的產品銷往 165 個國家，在全球擁有 36 個製造、研發和包裝基地。其中八個設施位於美國。我們在管理全球供應網路方面擁有深厚的專業知識，並且我們不斷採取措施，靈活應對未來的任何機會或挑戰。

While our global and diverse supply chain is optimized to support patients where they live, as a US company, we have been in the past and continue to be today firmly committed to manufacturing in the United States. Last year, we manufactured approximately 8.5 billion doses in the US and more than 50% of our US revenue is currently sourced from a US manufacturing site.

雖然我們全球多樣化的供應鏈已進行了優化，以支持患者居住地，但作為一家美國公司，我們過去和現在都堅定地致力於在美國製造。去年，我們在美國生產了約 85 億劑疫苗，目前在美國超過 50% 的收入來自美國製造基地。

We look forward to understanding more about the specifics around the executive order issued earlier this week as we continue to explore ways to optimize the flexibility of our global network, including the potential to increase our manufacturing capacity in the US. We remain focused on ensuring we have the right footprint in the right places so we can continue to serve our patients worldwide, while also maintaining a profitable and sustainable business.

我們期待更多地了解本週早些時候發布的行政命令的具體內容，同時我們將繼續探索優化全球網路靈活性的方法，包括增加我們在美國製造能力的潛力。我們始終致力於確保我們在正確的地方擁有正確的足跡，以便我們能夠繼續為全球患者提供服務，同時保持盈利和可持續發展的業務。

I am now very excited to talk about the most recent addition to our executive leadership team. Hemanth Varghese joined us in April as Chief Strategy Officer. He brings deep experience across the biotech and pharmaceutical industries and in every area of our portfolio, generics, complex generics, brands, and innovative products. He also holds a PhD in medical biophysics, giving him a unique perspective into the healthcare industry. I look forward to working with Hemanth, the rest of our leadership team, and in fact, all of our colleagues globally as we continue to work to drive our base business, execute on our pipeline, return capital to shareholders, and position ourselves for growth in 2026 and beyond.

現在，我非常高興地談論我們執行領導團隊的最新成員。Hemanth Varghese 於四月加入我們，擔任首席策略長。他在生物技術和製藥行業以及我們產品組合的各個領域（仿製藥、複雜仿製藥、品牌和創新產品）都擁有豐富的經驗。他還擁有醫學生物物理學博士學位，這使他對醫療保健產業有著獨特的見解。我期待與 Hemanth、我們領導團隊的其他成員以及我們全球的所有同事合作，繼續努力推動我們的基礎業務、執行我們的產品線、向股東返還資本，並為 2026 年及以後的成長做好準備。

Now, let me turn it over to Philippe to discuss the exciting developments in our pipeline in more detail. Philippe?

現在，讓我將話題交給 Philippe，讓他更詳細地討論一下我們管道中令人興奮的進展。菲利普？

Thank you, Scott. We have strong momentum advancing our Phase 3 programs, which is one of our key priorities this year. We previously mentioned that we would have six Phase 3 readouts in 2025. We've already had the first three readouts, and I'm pleased to report that all three are positive. These programs are now moving to the regulatory submission preparation phase.

謝謝你，斯科特。我們第三階段計劃的推進勢頭強勁，這是我們今年的重點工作之一。我們之前提到過，我們將在 2025 年進行六次第三階段的讀數。我們已經收到了前三次讀數，我很高興地報告，三次讀數都是正面的。這些項目目前正進入監管提交準備階段。

Let's begin with the Phase 3 readout of our investigational MR-107A-02 program for the treatment of moderate to severe acute pain that we announced earlier today. The development of safe and effective alternative treatments to opioids is an important public health need. The improvement in pain we observed from our fast-acting meloxicam compared to placebo was statistically significant and clinically meaningful, building on an established mechanism of action and well-characterized safety profile.

讓我們從我們今天早些時候宣布的用於治療中度至重度急性疼痛的 MR-107A-02 研究計劃的第三階段讀數開始。開發安全有效的鴉片類藥物替代療法是一項重要的公共衛生需求。與安慰劑相比，我們觀察到速效美洛昔康對疼痛的改善具有統計意義和臨床意義，這是建立在既定的作用機制和明確的安全性基礎上的。

All primary and secondary endpoints were met in both Phase 3 studies. These results were consistent across multiple post-surgical models of moderate to severe acute pain. We believe that when approved, this oral non-opioid analgesic option for the treatment of moderate to severe acute pain will get us closer to addressing this important public health need.

兩項 3 期研究均達到了所有主要和次要終點。這些結果與多種中度至重度急性疼痛術後模型一致。我們相信，一旦獲得批准，這種用於治療中度至重度急性疼痛的口服非鴉片類止痛藥將使我們更接近解決這一重要的公共衛生需求。

In addition to placebo, these trials included an opioid arm, Tramadol 50 milligram given every six hours to confirm the sensitivity of the pain model. Importantly, and in contrast to recently approved agents, our fast-acting meloxicam demonstrated superior pain control versus the opioid arm in both surgical models, further strengthening its value as a potential non-opioid option for acute, moderate to severe pain. For context, this regimen of Tramadol equals 40 year-old morphine equivalents, which is two-fold higher than hydrocodone 20 milligram.

除了安慰劑之外，這些試驗還包括鴉片類藥物組，每六小時服用 50 毫克曲馬多，以確認疼痛模型的敏感性。重要的是，與最近批准的藥物相比，我們的速效美洛昔康在兩種手術模型中都表現出比阿片類藥物更好的疼痛控制效果，進一步加強了其作為治療急性、中度至重度疼痛的潛在非阿片類藥物的價值。就背景而言，這種曲馬多療法相當於 40 年前的嗎啡當量，比 20 毫克氫可酮高出兩倍。

Additionally, our fast-acting Meloxicam demonstrated a significant reduction in opioid usage across both studies. This was demonstrated by a significant reduction in opioid use versus placebo and a significantly higher number of opioid-free patients on fast-acting Meloxicam than placebo. Our fast-acting Meloxicam were generally well tolerated. In both studies, incidence of TEAEs was comparable to placebo in a post-surgical setting. Few severe TEAEs and SAEs were reported with a rate consistent with placebo. No TEAEs leading to death were reported.

此外，我們的速效美洛昔康在兩項研究中均顯示鴉片類藥物使用量顯著減少。這表明，與使用安慰劑相比，阿片類藥物的使用量顯著減少，並且使用速效美洛昔康的無鴉片類藥物患者數量明顯高於使用安慰劑的患者。我們的速效美洛昔康通常耐受性良好。在這兩項研究中，術後 TEAE 的發生率與安慰劑相當。報告的嚴重 TEAE 和 SAE 很少，其發生率與安慰劑一致。未報告導致死亡的 TEAE。

These two pivotal studies optimally position our fast-acting meloxicam for potential first-line treatment for moderate to severe acute pain. The company is targeting to submit a new drug application to the FDA by the end of the year based on the positive data from these two Phase 3 studies and the supportive positive Phase 2 dose-ranging finding data in dental pain. We also anticipate that the full data set from both Phase 3 studies will be presented during the PAINWeek Medical Conference in September in Las Vegas.

這兩項關鍵研究使我們的速效美洛昔康成為中度至重度急性疼痛的潛在第一線治療藥物。該公司計劃根據這兩項 3 期研究的積極數據以及牙痛方面 2 期劑量範圍研究的支持性積極數據，在年底前向 FDA 提交新藥申請。我們也預計這兩項 3 期研究的完整數據集將於 9 月在拉斯維加斯舉行的 PAINWeek 醫學會議上公佈。

Next, let me provide more details about the positive results from our investigational XULANE LO Phase 3 readout that we have also announced today. There are three important conclusions from the study. One, it confirmed the effectiveness of XULANE LO weekly patch for birth control in women of childbearing potential.

接下來，讓我提供更多有關我們今天宣布的 XULANE LO 第 3 階段研究讀數的積極結果的詳細資訊。研究得出三個重要結論。一是證實了XULANE LO每週貼片對育齡婦女避孕的有效性。

Two, it demonstrated a favorable safety and tolerability profile with most TEAEs reported as mild to moderate and no new safety concerns identified. And three, it demonstrated potential best-in-class patch performance with very few patches completely detaching over the seven-day wearing period, and less than 1% of trial subjects reporting severe local application site reactions.

其次，它表現出良好的安全性和耐受性，大多數 TEAE 報告為輕度至中度，並且沒有發現新的安全問題。第三，它展現出了同類最佳的貼片性能，在七天的佩戴期內，很少有貼片完全脫落，並且不到 1% 的試驗對象報告了嚴重的局部應用部位反應。

Overall, we are pleased with the results, and believe XULANE LO also has the potential to address an important unmet need for women seeking a reversible birth control option with a lower dose of estrogen. We also design our patch with certain texture and sizing properties that we believe could be appealing to women who are seeking another weekly birth control patch option.

總體而言，我們對結果感到滿意，並相信 XULANE LO 也有潛力滿足女性尋求低劑量雌激素可逆避孕方法的重要未滿足需求。我們還設計了具有特定紋理和尺寸特性的貼片，我們相信這些特性可能會吸引那些正在尋求另一種每週避孕貼片選擇的女性。

Viatris has a long history and strong track record of developing and manufacturing dermal patches at our R&D and manufacturing facilities in Vermont. We are looking forward to progressing this product toward regulatory submission, which we anticipate will be in the second half of this year. We also anticipate that the result from this Phase 3 study will be presented at the next American College of Obstetricians and Gynecologists Conference.

Viatris 在佛蒙特州的研發和製造工廠中擁有開發和製造皮膚貼片的悠久歷史和良好的業績記錄。我們期待該產品能夠順利提交監管部門，預計提交將在今年下半年完成。我們也預期這項第三階段研究的結果將在下一屆美國婦產科醫師學會會議上公佈。

Our remaining Phase 3 readouts anticipated this year relate to our ophthalmology programs. We remain on track to receive three key Phase 3 registrational readouts in the first half of the year. These include Pimecrolimus for blepharitis, Phentolamine Ophthalmic solution for presbyopia and for visual loss in low-light condition associated with keratorefractive surgery.

我們預計今年剩餘的第三階段讀數與我們的眼科項目有關。我們仍有望在今年上半年收到三份關鍵的第三階段註冊讀數。這些藥物包括用於治療眼瞼炎的吡美莫司、用於治療老花眼和角膜屈光手術相關的弱光條件下視力喪失的酚妥拉明眼液。

As for other advancements in our pipeline, our regulatory team is hard at work advancing key submissions. We recently filed application to the Japanese health authorities for approval of EFFEXOR for the treatment of adults with generalized anxiety disorder.

至於我們管道中的其他進展，我們的監管團隊正在努力推進關鍵提交。我們最近向日本衛生當局提交了申請，希望批准使用 EFFEXOR 來治療成人廣泛性焦慮症。

There is no other treatment option currently approved for this indication in Japan. Our positive results from our previously announced Phase 3 efficacy and safety studies laid the foundations for our applications. We are also pleased that these results have been accepted as a poster presentation at the Japanese Society of Neurology and Psychiatry Conference. In addition, we are focused on preparing our submissions for Sotagliflozin in a number of ex-US markets. Our findings in UAE and Saudi Arabia have been submitted, and we expect to submit our findings in Canada soon.

目前日本尚無其他針對此症狀的治療方案獲準。我們先前宣布的第三階段功效和安全性研究的積極成果為我們的應用奠定了基礎。我們也很高興這些結果已被接受為日本神經病學和精神病學學會會議上的海報展示。此外，我們也致力於準備向美國以外的多個市場提交 Sotagliflozin 的申請。我們在阿聯酋和沙烏地阿拉伯的調查結果已經提交，我們預計很快就會在加拿大提交我們的調查結果。

Moving to Selatogrel and Cenerimod. Enrollment for both programs remains on schedule. We recently presented data at PANLAR that covered the multifaceted immunomodulatory properties of Cenerimod. Also, we are pleased to share the acceptance of our abstracts covering data from the additional analyses of the Phase 2 care study, providing information related to fatigue and quality of life at LUPUS 2025 and maintenance of response at EULAR 2025.

轉向 Selatogrel 和 Cenerimod。兩個項目的招生工作均按計劃進行。我們最近在 PANLAR 上展示了涵蓋 Cenerimod 多方面免疫調節特性的數據。此外，我們很高興地分享我們的摘要被接受的消息，該摘要涵蓋了第 2 階段護理研究的附加分析數據，提供了與 LUPUS 2025 的疲勞和生活質量以及 EULAR 2025 的反應維持相關的信息。

We look forward to continuing to engage with the rheumatology and LUPUS scientific and patient communities at several congresses throughout the year. For Selatogrel, we had very productive discussions at the recent American College of Cardiology Congress and continue to see strong interest in the trial within the cardiology community.

我們期待在全年的幾次會議上繼續與風濕病學和狼瘡科學和患者社群進行交流。對於 Selatogrel，我們在最近的美國心臟病學會大會上進行了非常富有成效的討論，並繼續看到心臟病學界對該試驗的濃厚興趣。

Lastly, regarding our best business portfolio, we are on track with the approvals required for us to deliver $450 million to $550 million of new product revenue this year, including our anticipated approval for Iron Sucrose, Octreotide, and Liraglutide. Overall, it's a strong start to the year. Our R&D strategy is driven by our deep in-house development capabilities and expertise. And we are very pleased with our steady discipline progress today.

最後，關於我們最好的業務組合，我們正在按計劃獲得所需的批准，以便我們今年實現 4.5 億至 5.5 億美元的新產品收入，包括我們預期的蔗糖鐵、奧曲肽和利拉魯肽的批准。總體而言，這是今年的一個好開始。我們的研發策略由我們深厚的內部開發能力和專業知識所驅動。我們對今天紀律方面的穩步進步感到非常高興。

I will now turn the call to Doretta.

現在我將把電話轉給多蕾塔。

Thank you, Philippe, and good morning, everyone. I'm glad you could join us. Today I will walk you through the key drivers and takeaways for the quarter. The progress we're making against our capital allocation plan and our outlook for the remainder of the year.

謝謝你，菲利普，大家早安。我很高興你能加入我們。今天，我將向您介紹本季的關鍵驅動因素和要點。我們在資本配置計劃方面取得的進展以及對今年剩餘時間的展望。

Our first quarter results were in line with our expectations and reflect our well diversified global business. Total revenues for the quarter were $3.25 billion, down 2% versus the prior year. The impact from Indore in the first quarter was approximately $140 million, which was in line with our expectations. Excluding this impact, operational revenue would have increased 2% versus the prior year. As Scott mentioned, the remediation effort at Indore is progressing as planned.

我們第一季的業績符合我們的預期，並反映了我們多元化的全球業務。本季總營收為 32.5 億美元，較上年下降 2%。第一季印多爾的影響約為 1.4 億美元，符合我們的預期。排除此影響，營業收入將比上年增長 2%。正如斯科特所說，印多爾的修復工作正在按計劃進行。

Our revenues benefited from growth in our brands of 3%. This was primarily driven by the expansion of our cardiovascular portfolio in emerging markets and growth in greater China and developed markets. In developed markets, overall net sales were impacted by declines in our generics business, partially offset by growth in brands.

我們的收入受益於我們品牌 3% 的成長。這主要得益於我們在新興市場的心血管產品組合的擴張以及大中華區和已開發市場的成長。在已開發市場，整體淨銷售額受到仿製藥業務下滑的影響，但被品牌藥業務的成長部分抵銷。

From a regional perspective, we continue to see consistent and durable growth from our European business, growing approximately 1% this quarter. The brand portfolio grew 2% led by Creon, Brufen, and our Thrombosis portfolio. Generics performance was flat year-over-year despite the Indore impact and continues to benefit from key markets, such as France.

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 1%。品牌組合成長了 2%，主要由 Creon、Brufen 和我們的血栓產品組合帶動。儘管受到印多爾的影響，仿製藥的業績與去年同期持平，並繼續受益於法國等主要市場。

Our North American business decreased 8% versus the prior year, primarily as a result of the Indore impact and competition on select generic products which was expected. This was partially offset by new product revenues and continued growth in Breyna. In emerging markets, net sales decreased approximately 5% versus the prior year, primarily driven by the Indore impact and customer buying patterns affecting the ARV generics business. Partially offsetting this performance was growth in brands across the cardiovascular portfolio in certain Latin American countries and continued strengths in the MENA and Eurasia regions.

我們的北美業務較上年下降了 8%，主要原因是預期中的印多爾影響和部分仿製藥的競爭。但新產品收入和布雷納的持續成長部分抵消了這一影響。在新興市場，淨銷售額較前一年下降約 5%，主要原因是印多爾疫情以及客戶購買模式影響了抗愛滋病毒藥物仿製藥業務。部分抵消了這一表現的是某些拉丁美洲國家的心血管產品組合品牌的成長以及中東和北非以及歐亞地區的持續優勢。

In our JANZ segment, net sales decreased approximately 6%. Results were primarily driven by expected government price regulations in Japan and Australia and a change in reimbursement impacting off-patent brands in Japan. This was partially offset by volume increases in the generics portfolio. Lastly, we see continued positive momentum in greater China. Net sales grew 4%, which was as a result of our diversified model across e-commerce, retail, and private hospitals. This led to growth across the portfolio, particularly brands that are sensitive to proactive patient choice.

在我們的 JANZ 部門，淨銷售額下降了約 6%。結果主要受到日本和澳洲預期的政府價格監管以及影響日本非專利品牌的報銷變化的影響。但這一成長被仿製藥產品組合的銷售成長部分抵銷。最後，我們看到大中華區繼續呈現正面動能。淨銷售額成長了 4%，這得益於我們涵蓋電子商務、零售和私人醫院的多元化模式。這帶動了整個產品組合的成長，特別是那些對患者主動選擇敏感的品牌。

In looking at the P&L, adjusted gross margin of approximately 56% in the quarter was in line with expectations. As anticipated, margins declined versus the prior year due to price regulations and JANZ, the impact of Indore, and the increase in certain product supply costs. Operating expenses were roughly flat versus prior year. Cost savings initiatives benefiting SG&A were offset by investments in R&D to advance our innovative pipeline.

從損益表來看，本季調整後的毛利率約為 56%，符合預期。正如預期的那樣，由於價格管制和 JANZ、印多爾的影響以及某些產品供應成本的增加，利潤率較上年下降。營業費用與上年基本持平。有利於銷售、一般及行政費用的成本節約措施被用於推動我們創新管道的研發投資所抵銷。

Finally, the company had a triggering event for goodwill impairment testing in the first quarter due to a decline in our share price and the increased uncertainty and volatility in the geopolitical and economic environments in which we operate. As a result, for US GAAP purposes, we recorded a non-cash goodwill impairment charge of $2.9 billion, driven by an increase in discount rate assumptions reflecting the increased business risk. Despite this, we remain confident in our base business outlook and in our ability to deliver on our expectations for the year.

最後，由於我們股價下跌以及我們經營所在的地緣政治和經濟環境的不確定性和波動性增加，該公司在第一季發生了商譽減損測試的觸發事件。因此，根據美國公認會計準則，我們記錄了 29 億美元的非現金商譽減損費用，這是由於折現率假設的增加反映了業務風險的增加。儘管如此，我們仍然對我們的基本業務前景以及實現今年預期的能力充滿信心。

Turning to free cash flow, for the quarter it was $493 million and would have been $535 million excluding transaction costs and taxes from the divestitures. Moving to capital allocation, we continue to prioritize capital return and since the beginning of the year, we have repurchased over $300 million worth of shares. Including our Q1 dividend payment, we are pleased to have already returned more than $450 million of capital to our shareholders.

談到自由現金流，本季為 4.93 億美元，如果扣除交易成本和資產剝離稅費，則為 5.35 億美元。在資本配置方面，我們繼續優先考慮資本回報，自今年年初以來，我們已經回購了價值超過 3 億美元的股票。包括第一季的股息支付在內，我們很高興向股東返還了超過 4.5 億美元的資本。

Now, a few comments on our outlook and phasing for the rest of the year. Based on the performance in the first quarter and trends we are seeing across the business, we are reaffirming our outlook for the year. Within our guidance, the drivers of total revenue include no change to the base business outlook, including the estimated financial impact from Indore, and continued confidence in meeting our new product revenue range of $450 million to $550 million.

現在，我們對今年剩餘時間的展望和分階段發表一些評論。根據第一季的表現和我們看到的整個業務趨勢，我們重申對今年的展望。在我們的指導範圍內，總收入的驅動因素包括基本業務前景沒有變化，包括來自印多爾的預期財務影響，以及對實現 4.5 億至 5.5 億美元新產品收入範圍的持續信心。

While foreign exchange has been volatile, we've seen spot rates move favorably over the past month. And if current rates hold for the remainder of the year, this could offset the 2% to 3% headwind we had previously incorporated in our full year revenue guidance.

儘管外匯一直波動，但我們看到過去一個月現貨匯率走勢良好。如果目前的利率在今年剩餘時間內保持不變，這可能會抵消我們先前在全年收入預測中納入的 2% 至 3% 的不利因素。

Due to finalizing an agreement to expand our commercial rights for Cenerimod, adjusted EBITDA and adjusted EPS guidance reflects a $10 million impact from IPR&D. Adjusted EPS also reflects the benefit from share repurchases executed to date. It's important to note that our guidance does not account for any potential impact related to industry tariffs.

由於最終達成擴大 Cenerimod 商業權利的協議，調整後的 EBITDA 和調整後的 EPS 指引反映了 IPR&D 帶來的 1000 萬美元的影響。調整後的每股盈餘也反映了迄今為止執行的股票回購帶來的收益。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。

With regards to anticipated phasing for the rest of the year, total revenues are still expected to be higher in the second half at approximately 52% of our full year outlook. This reflects the estimated impact of Indore, normal product seasonality, and back-weighted launches of new products. Adjusted EBITDA and adjusted EPS are still expected to be higher in the second half. And as a reminder, free cash flow is expected to be lowest in Q2 due to timing of semi-annual interest payments and working capital requirements.

就今年剩餘時間的預期分階段而言，預計下半年總收入仍將更高，約為全年預期的 52%。這反映了印多爾的預期影響、正常的產品季節性以及新產品的後加權推出。預計下半年調整後的 EBITDA 和調整後的 EPS 仍將更高。需要提醒的是，由於半年利息支付的時間和營運資金需求，預計第二季的自由現金流將最低。

In conclusion, I want to take the opportunity to reiterate our confidence in the fundamentals of our business and the progress we continue to make executing against our strategic priorities. Our well-diversified global business and our strong cash flow enables us to continue delivering on returning capital to our shareholders. We believe we are well positioned to meet our expectations for the remainder of this year.

最後，我想藉此機會重申我們對業務基本面的信心以及我們在執行策略重點方面繼續取得的進展。我們多元化的全球業務和強勁的現金流使我們能夠繼續向股東提供資本回報。我們相信，我們有能力實現今年剩餘時間的預期。

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。

Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions)

女士們、先生們，我們現在開始問答環節。（操作員指示）

Chris Schott, JP Morgan.

摩根大通的克里斯·肖特。

Great. Thanks so much. Just two questions for me. Maybe first on the meloxicam opportunity. Can you just help us frame out how you're thinking about the peak sales opportunity and kind of the ramp once approved for this drug? And how much of your existing infrastructure can you leverage to launch the product?

偉大的。非常感謝。我只有兩個問題。也許是美洛昔康的第一個機會。您能否幫助我們闡述一下，您如何看待這種藥物的銷售高峰機會以及一旦獲得批准後的增長方式？您可以利用多少現有基礎設施來推出產品？

And then my second question was just on tariffs. Scott, I appreciate some of the comments in the opening remarks, but for the 50% of your sales in the US that aren't manufactured domestically, how should we think about the company's ability to mitigate the impact there? Maybe specifically, is there opportunity to take price tops off some of this, and is there capacity within the US manufacturing network to shift things to the US if needed? Thanks so much.

我的第二個問題是關於關稅的。史考特，我很欣賞開場白中的一些評論，但是對於你們在美國 50% 的銷售額不是在國內生產的，我們應該如何看待公司減輕其在美國的影響的能力？也許具體來說，是否有機會降低部分價格，而美國製造網路是否有能力在必要時將產品轉移到美國？非常感謝。

Good morning, Chris, and thank you for the question. Let me answer the tariff question first, and then I'll kick it over to Corinne and to potentially Philippe to talk a little bit about meloxicam.

早安，克里斯，謝謝你的提問。讓我先回答關稅問題，然後我會把它交給 Corinne，可能還會交給 Philippe，讓他們談談美洛昔康。

So yes, so more than 50% of our US revenues come from US-based manufacturing. We have eight manufacturing R&D packaging sites here. We already produce 8.5 billion doses here annually. The countries we import from into the US where we don't manufacture in the US are Ireland, the UK, and India.

是的，我們美國收入的 50% 以上來自美國製造業。我們在這裡有八個製造研發包裝基地。我們每年已經在這裡生產85億劑疫苗。我們從愛爾蘭、英國和印度進口產品但不在美國生產。

And obviously, we don't know where tariffs are going to land, but we've been involved in a lot of mitigation strategies, both short-term and long-term, thinking about what it is that we can do. So we're focused on, of course, increasing production within the US network that we have already. We're looking at adjusting our inventory levels for the US market.

顯然，我們不知道關稅最終會落到什麼程度，但我們已經參與了許多短期和長期的緩解策略，思考我們能做些什麼。因此，我們當然專注於提高我們現有的美國網路內的產量。我們正在考慮調整美國市場的庫存水準。

In the longer term, we're looking at things like transfers, leveraging third parties here in the US, investment potentially in a larger US network of manufacturing facilities. So, we can control only what we can control. I don't know where the tariffs are going to land, but we're looking at a wide variety of mitigation strategies to be able to handle any -- whatever comes at us from the tariffs.

從長遠來看，我們正在考慮轉移、利用美國的第三方、以及對美國更大的製造設施網路進行潛在投資等事宜。所以，我們只能控制我們能夠控制的事情。我不知道關稅最終會達到什麼程度，但我們正在研究各種緩解策略，以便能夠應對關稅帶來的任何影響。

And I will say though that, if there are significant tariffs enacted in the pharma sector, it's likely to have a financial impact on the company. I think, the degree to which I can't say, but we're doing everything we can to mitigate that. But from my perspective, just as important as that, or maybe more important as this idea of patient access, and I think the discussions that we're having with the administration and with Congress are around the ability of the generic industry particularly to be able to continue to provide access to patients for all medications.

不過我要說的是，如果對製藥業徵收高額關稅，可能會對公司產生財務影響。我想，我無法說出其程度，但我們正在盡一切努力來減輕這種影響。但從我的角度來看，這同樣重要，或者可能比患者獲得藥物的這個想法更重要，我認為我們與政府和國會進行的討論是圍繞仿製藥行業的能力，特別是能夠繼續為患者提供所有藥物的能力。

So we're trying to get our messages across, but in the meantime we're very, very involved, I would say, on a daily basis talking about mitigation strategies to minimize any impact that may come both financially and for patients.

因此，我們正在努力傳達我們的訊息，但同時，我想說，我們也非常投入，每天都在討論緩解策略，以盡量減少對經濟和患者可能造成的影響。

So I'll kick it over to Corinne.

所以我會把它交給 Corinne。

Yes, so good morning, Chris. Before I give you a bit of some color on how we see the positioning of fast-acting meloxicam, I just would like to ask first, Philippe, to comment a bit on the data.

是的，早上好，克里斯。在我向您介紹我們如何看待速效美洛昔康的定位之前，我想先請菲利普對數據發表一些評論。

Yes. So -- thank you. I think the profile that we've seen we're very happy with from both Phase 3 studies. The results were very consistent across two studies. We made all primary and key secondary endpoints. And importantly, we were also able to show a superior profile versus our opioid comparator, which, as I said in my remark, is a highly potent comparator which has been shown to be highly efficacious in these two models of hernia and bunionectomy in clinical trials.

是的。所以——謝謝你。我認為，我們對這兩個第三階段研究的結果非常滿意。兩項研究的結果非常一致。我們完成了所有主要終點和關鍵次要終點。重要的是，我們還能夠顯示出與阿片類藥物相比更優越的特性，正如我在評論中所說，這是一種非常有效的比較劑，在臨床試驗中已被證明對這兩種疝氣和拇囊切除術模型非常有效。

And it's about two-fold more potent than (inaudible) 20 milligrams. So we feel very strongly about our data versus this opioid comparator. On top of it, we were able to demonstrate significantly lower opioid usage than placebo in this study, which could be extremely important going forward. The safety profile was also well-tolerated. Incidence of TEAEs were comparable to placebo. Fewer TEAEs and SAEs were reported with a rate consistent with placebo as well. So overall, the benefit-risk profile emerging from these Phase 3 study positions is very well for first-line treatment.

它的效力比（聽不清楚）20 毫克高出兩倍。因此，我們對我們的數據與阿片類藥物比較的結果非常有信心。最重要的是，我們在這項研究中證明阿片類藥物的使用量明顯低於安慰劑，這在未來可能極為重要。安全性也具有良好的耐受性。TEAE 的發生率與安慰劑相當。報告的 TEAE 和 SAE 發生率也與安慰劑組一致。因此總體而言，這些 3 期研究結果顯示的獲益風險狀況對於第一線治療而言非常好。

So, Chris, obviously we are very pleased with the data. Just to give you an idea of how we look at the potential of this asset, it is potentially a large addressable market. There are about over 70 million acute pain cases annually in the United States. More than 80 million patients take pain medication for acute pain on a yearly basis, and we still see an over-reliance on opioids despite addiction risk. So the market demands for safer alternatives, non-saving alternatives, strong efficacy products with an established safety profile. And we believe that the novel fast-acting meloxicam can fit what the market is asking for.

所以，克里斯，顯然我們對這些數據非常滿意。只是為了讓您了解我們如何看待該資產的潛力，它是潛在的巨大目標市場。美國每年約有超過7000萬例急性疼痛病例。每年有超過 8000 萬名患者服用止痛藥來治療急性疼痛，儘管有成癮風險，我們仍然看到對鴉片類藥物的過度依賴。因此，市場需要更安全的替代品、不節約的替代品、具有成熟安全性的強效產品。我們相信，新型速效美洛昔康能夠滿足市場的需求。

So potentially, this asset could fit seamlessly both into the inpatient and outpatient care pathways. It will be a good treatment alternative for acute care management and has a very competitive profile. And we're in the process of refining our forecasts, so I cannot disclose any data at this point, but we'll make sure that we'll keep you abreast of our progress here.

因此，這種資產有可能無縫地融入住院和門診護理途徑。它將成為急性護理管理的良好治療替代方案，並且具有非常有競爭力。我們正在完善我們的預測，因此目前我無法透露任何數據，但我們會確保隨時向您通報我們的進展。

And just one final comment from me, Chris, and that is, I've been involved directly in a number of pain launches over my many years. When I take a look at this data, and it's really fresh and new data for us, it's very, very compelling. I think we have a really nice opportunity to have a major position in the acute market going forward here.

克里斯，我最後想說一句，多年來，我直接參與許多痛苦的發射。當我查看這些數據時，我發現它們對我們來說確實是新鮮的數據，非常非常引人注目。我認為我們有一個非常好的機會在未來的急性市場中佔據重要地位。

Ash Verma, UBS.

瑞銀的 Ash Verma。

Thanks for taking your questions. Maybe just on the share repurchases, I see you've done $300 million already and aiming for $500 million to $650 million. Is there more appetite here to go up substantially on the repo given where the stock is?

感謝您回答問題。也許僅在股票回購方面，我看到您已經完成了 3 億美元，目標是 5 億至 6.5 億美元。考慮到股票的現狀，是否有更大的興趣大幅提高回購價格？

Then secondly, on MR-107, can you help us understand how fast acting is this? For example, how quickly does this get static benefit in terms of hours, let's say, on the primary endpoint on the Slide 15? And then can you get a fast-acting claim on the label versus, let's say, MOBIC. Thanks.

其次，關於 MR-107，您能幫助我們了解它的作用速度有多快嗎？例如，就投影片 15 上的主要終點而言，這能多快獲得以小時為單位的靜態效益？然後，你能否在標籤上獲得與 MOBIC 相比具有快速起效的聲明？謝謝。

So, good morning, Ash. And thank you for the question. And I'll take the first one on capital allocation. Philippe can talk a little bit more about the Meloxicam and the data. We've already, as you noted, repurchased more than $300 million to this point in time. We're going to -- we're firmly committed to our goal of $500 million to $650 million.

早上好，Ash。感謝您的提問。我將首先討論資本配置問題。菲利普可以再多談一些有關美洛昔康和數據的事情。正如您所說，到目前為止我們已經回購了超過 3 億美元。我們將堅定地致力於實現 5 億至 6.5 億美元的目標。

Given the environment and the volatility in the macro environment, we want to -- and tariff uncertainty and things -- we don't -- we want to keep a little bit of strategic flexibility in terms of our capital allocation. It's potential -- potentially we may lean in even more and do more than $650 million, but we're going to sort of let the year play out, given the uncertainty and see where we are. But give them where the share price is. This is the year where we've talked about really leaning into the share repurchases as an important part of our capital allocation plan.

考慮到環境和宏觀環境的波動性，我們希望——以及關稅的不確定性和其他因素——我們不想——我們希望在資本配置方面保持一點戰略靈活性。這是有可能的——我們可能會投入更多資金，超過 6.5 億美元，但考慮到不確定性，我們將讓這一年慢慢來，看看我們現在處於什麼位置。但告訴他們股價在哪裡。今年我們討論了將股票回購作為資本配置計畫的重要部分。

And importantly, I would also say nothing has changed in terms of our expectations of the ability to generate free cash flow for the year and have about $1.7 billion of deployable cash flow. And so, to Scott's point, we do have the strategic flexibility as we move forward to the year. We have multiple levers that we can push and play with.

重要的是，我還要說，我們對今年產生自由現金流的能力以及約 17 億美元可部署現金流的預期沒有任何變化。因此，正如斯科特所說，隨著新年的到來，我們確實擁有戰略靈活性。我們有多個可以推動和使用的槓桿。

Okay. Thank you, Ash. On the question about our fast-acting meloxicam in terms of time of response. We measured it in both Phase 3 studies. We looked at median time to meaningful pain relief and median time to perceptible pain relief. And we saw a fast-acting meloxicam to put this data in context against others and you have that data in the slide that we provided. But to put that data in context, we also did a post-hoc analysis where we looked at 2 points or more reduction in NPR from baseline, which has been demonstrated with others, and we were very fast with 95 minutes versus a placebo of 338 minutes.

好的。謝謝你，阿什。關於我們的速效美洛昔康的反應時間的問題。我們在兩個第三階段研究中都對其進行了測量。我們觀察了達到有意義疼痛緩解的中位數時間和達到可察覺疼痛緩解的中位數時間。我們看到了一種速效美洛昔康，可以將這些數據與其他數據進行比較，您可以在我們提供的幻燈片中看到這些數據。但為了將這些數據放在上下文中，我們還進行了事後分析，我們觀察了 NPR 與基線相比減少 2 個點或更多的情況，這已經得到其他人的證實，而且我們的速度非常快，為 95 分鐘，而安慰劑為 338 分鐘。

So we feel that the fast-acting properties of -- our fast-acting meloxicam have been demonstrated in Phase 3 twice in both studies. As to whether we are able to get a claim, I think I don't want to speculate on what FDA may or may not do, but we certainly have the conversation with the agency.

因此，我們認為，我們的速效美洛昔康的速效特性已在兩項研究的第三階段中得到兩次證實。至於我們是否能夠獲得索賠，我想我不想猜測 FDA 可能會做什麼或不會做什麼，但我們肯定會與該機構進行對話。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Hey, thanks. So, a couple for me. On Indore, can you talk about 2026 and the potential for impact to spill over into 2026. How should we think about that? Also, there's another facility in India, and I apologize if I missed any commentary on this, but can you talk about your inspection at the other facility in India that happened last year and where things stand on that.

嘿，謝謝。所以，對我來說是一對。關於印多爾，您能談談 2026 年以及其影響延續到 2026 年的可能性嗎？我們該如何看待這個問題？此外，印度還有另一家工廠，如果我錯過了任何評論，我深感抱歉，但您能否談談去年對印度另一家工廠的檢查情況以及目前的情況。

And then switching gears regarding strategic priorities and BizDev M&A, can you talk to your appetite for taking on assets that are in mid to late stage development along the lines of Cenerimod and Selatogrel. How are you thinking about development stage assets versus your appetite for commercial stage brand assets? Thank you.

然後轉換關於策略重點和業務發展併購的話題，您能否談談您對收購 Cenerimod 和 Selatogrel 等處於中後期開發階段的資產的興趣。您如何看待開發階段的資產以及對商業階段品牌資產的興趣？謝謝。

So, thank you. Good morning, David. Yes, so the remediation in Indore is coming along fine. We are at progress as expected. We expect to submit a request for a reinspection mid-year. We can only control what we can control. We can't control the timing of that inspection. So we're making sure that we also qualify other plants in the network outside of Indore to be able to supply the US network. I think we'll see significant rebound in Indore-related products as we move into 2026. Some, like lenalidomide sort of go away as we get into 2026, but we should see some restoration of our products from Indore in 2026, and we don't think it will have a significant impact on our overall financials.

所以，謝謝你。早安，大衛。是的，印多爾的修復工作進展順利。我們正在按照預期取得進展。我們預計將在年中提交重新檢查的請求。我們只能控制我們能夠控制的事情。我們無法控制該檢查的時間。因此，我們要確保印多爾以外網路中的其他工廠也有資格向美國網路供貨。我認為，隨著 2026 年的到來，我們將看到印多爾相關產品大幅反彈。有些產品，例如來那度胺，在 2026 年就會逐漸消失，但我們應該會看到我們在 2026 年從印多爾獲得的產品有所恢復，我們認為這不會對我們的整體財務狀況產生重大影響。

In terms of Nashik, the same status it's been, that inspection happened approximately a year ago. We got a 483. We have not heard from the FDA relative to the classification of that inspection. And we have importantly completed all committed actions that we agreed to with the FDA on that plan. So we're waiting to see. We've also qualified other facilities in the network as well in case there is any action in a Nashik. But we're waiting to hear back from the FDA on that. And again, we've completed all committed actions at this point in time.

就納西克而言，情況一直如此，那次檢查大約在一年前進行。我們得到了483。我們尚未收到 FDA 關於該次檢查分類的回應。重要的是，我們已經完成了與 FDA 就該計劃達成的所有承諾行動。所以我們拭目以待。我們也對網路中的其他設施進行了認證，以防納西克發生任何事件。但我們正在等待 FDA 的回覆。再次強調，我們目前已完成所有承諾的行動。

And just to add some color and contextualize on the potential Indore impact, we've talked about approximately $500 million revenue impact from Indore. As Scott mentioned, about 40% of that is lenalidomide related. And so, we don't anticipate that to come back. But about $100 million of that is due to penalties and short-term supply disruptions, which we don't anticipate occurring in 2026. And the remainder to Scott's point, we're in the process of either moving and is subject to the re-inspection and reputation of Indore.

為了補充一些資訊並說明印多爾的潛在影響，我們討論了印多爾約 5 億美元的收入影響。正如斯科特所提到的，其中約 40% 與來那度胺有關。因此，我們預計這種情況不會再次發生。但其中約 1 億美元是由於罰款和短期供應中斷造成的，我們預計這些情況不會在 2026 年發生。至於斯科特所指出的其餘部分，我們要么正在搬遷，要么接受印多爾的重新檢查和聲譽。

Thank you. And your second question was relative to our BD priorities. And I believe you said mid to late stage development assets. And first of all, I'd like to say that, we could not be more excited to have Cenerimod and Selatogrel in the portfolio. In the pipeline, the development of them is going very well. We've been able to accelerate the development and the timing of those assets. We've taken more control over the development programs. We've expanded the geography for Cenerimod. We're very, very excited about those assets.

謝謝。您的第二個問題與我們的 BD 優先事項有關。我相信您說的是中後期開發資產。首先，我想說的是，我們非常高興將 Cenerimod 和 Selatogrel 納入我們的產品組合。目前，它們的開發進展非常順利。我們已經能夠加速這些資產的開發和時機。我們對開發專案進行了更多的控制。我們擴大了 Cenerimod 的地理範圍。我們對這些資產感到非常非常興奮。

However, our business development focus right now is for in-market or very near-to-market assets. We want to be able to build short-term revenue and EBITDA. So we're looking at assets that are closest rather than mid-stage development, either very, very late stages that are close to launch or in market is what our focus is right now.

然而，我們目前的業務發展重點是市場內或接近市場的資產。我們希望能夠建立短期收入和 EBITDA。因此，我們關注的是最近而不是中期開發的資產，要么是接近推出的非常後期的階段，要么是市場上的資產，這是我們目前的重點。

Jason Gerberry, Bank of America.

美國銀行的 Jason Gerberry。

Hey, guys. This is Bhavin Patel on for Jason Gerberry. First question is that, the first quarter showed brand resilience, the generic weakness. So maybe if you can elaborate on the volume versus price drivers for key brands like Lipitor in developed markets in greater China. And then for generics beyond the quantified Indore impact, what drove the decline there and how sustainable is the overall 2% underlying core business growth, ex-divesters, ex-Indore that you saw this quarter?

嘿，大家好。這是 Jason Gerberry 的 Bhavin Patel。第一個問題是，第一季顯示出品牌彈性，通用性弱點。因此，能否詳細說明一下大中華區已開發市場上立普妥等主要品牌的銷售與價格驅動因素？那麼，對於仿製藥而言，除了量化的印多爾影響之外，是什麼導致了那裡的下滑，以及本季度看到的整體 2% 核心業務增長（不包括剝離者、印多爾）的可持續性如何？

And then my second question is that, the guidance assumes a significant second half ramp in revenue, EBITDA, and earnings per share. So maybe if you can provide some more color on the expected timing and contribution cadence within the second half from the key launches, including Iron Sucrose, Octreotide LAR, glucagon, which may or may not be needed to hit the $450 million to $550 million new product revenue target. Thank you.

我的第二個問題是，指引假設下半年營收、EBITDA 和每股盈餘將大幅成長。因此，如果您可以提供更多關於下半年主要產品發布的預期時間和貢獻節奏的信息，包括蔗糖鐵、長效奧曲肽、胰高血糖素，這些產品可能需要或不需要達到 4.5 億至 5.5 億美元的新產品收入目標。謝謝。

So, thank you very much for the question. Doretta, do you want to take that questions?

非常感謝您的提問。多蕾塔，你想回答這些問題嗎？

Yes, so let's start with the brand resilience. And to your point, we feel good about the momentum that we've seen on the brand side. I would say, it was really driven in a couple of pieces. Number one, in China we continue to see good momentum and uptake in our brand portfolio. There we reported 4% growth this quarter. The other area is in Europe. We saw great growth in our portfolio there with Creon, Brufen, as well as our Thrombosis portfolio. And so overall, to your point, we are seeing good momentum in brands.

是的，那麼就讓我們從品牌彈性開始吧。正如您所說，我們對品牌方面所看到的勢頭感到滿意。我想說，它實際上是由幾個部分推動的。首先，在中國，我們的品牌組合持續呈現良好勢頭和成長勢頭。我們報告本季成長了 4%。另一個地區是歐洲。我們的產品組合（包括 Creon、Brufen 以及血栓產品組合）均實現了巨大成長。總體而言，正如您所說，我們看到品牌發展勢頭良好。

On the generic portfolio, that part of our portfolio has been the most impacted by Indore. If you ex the impact of Indore, I would say, expectations and the performance of our generic portfolio is actually performing in line with what we expect.

在通用投資組合中，這部分投資組合受到印多爾的影響最大。如果您排除印多爾的影響，我想說，預期和我們的通用投資組合的表現實際上符合我們的預期。

With respect to guidance in the second half, as we mentioned, we do expect our performance to be second half weighted. About 52% of our revenue we expect to hit in second half. There is a couple of pieces to that. Number one, the Indore impact is expected to be more acute in the first half versus the second half. The second piece of that is, just the ramp of new product launches. I'll have Philippe talk a little bit about how we think about that, but we do expect new product launches to be slightly more second half weighted. And we do have normal product seasonality that occurs in the second half, especially as it relates to some of our portfolio in Europe. And that's what's letting us to some of the trends that we're seeing between the first half and the second half.

關於下半年的指導，正如我們所提到的，我們確實預計我們的業績將受到下半年的影響。我們預計下半年的收入將達到約 52%。其中有幾部分內容。首先，預計上半年印多爾的影響將比下半年更為嚴重。第二部分是新產品發布的加速。我會讓菲利普談談我們對此的看法，但我們確實預計下半年新產品的發表會會更加重要。我們的產品在下半年確實有正常的季節性，特別是與我們在歐洲的部分產品組合有關。這就是我們觀察到的上半年和下半年之間的一些趨勢。

Yes, and you mentioned a number of key launches. I just want to remind you that glucagon has been launched already. Iron Sucrose, Liraglutide and Octreotide are all scheduled for the second half of this year and so that's where we're on schedule with these three assets to get them approved in the second half.

是的，您提到了一些重要的發布。我只是想提醒你，胰高血糖素已經上市了。蔗糖鐵、利拉魯肽和奧曲肽都計劃在今年下半年上市，因此我們計劃按計劃在下半年批准這三種資產。

Umer Raffat, Evercore.

烏默·拉法特（Umer Raffat），Evercore。

Hi guys. Thanks for taking my questions. I have a few here if I may. First, if you could just remind us about your manufacturing network for your US business, the India facilities versus Morgantown and what percentage is made in US?

嗨，大家好。感謝您回答我的問題。如果可以的話我這裡有幾個。首先，您能否向我們介紹一下您在美國業務的製造網絡，印度工廠與摩根敦工廠的情況，以及在美國生產的百分比是多少？

On meloxicam, I had a couple of questions if I may. First, your trials are obviously in acute setting, in surgery setting, where traditionally meloxicam takes a few hours to kick in. So congrats to you on the data. My question to you is, surgeons have historically hesitated doing NSAIDs for bleeding reasons in surgery setting, and to what extent do you see your products usage in acute setting versus in chronic settings like arthritis where meloxicam has been used?

關於美洛昔康，如果可以的話我有幾個問題。首先，您的試驗顯然是在急性環境下、在手術環境下進行的，傳統上美洛昔康需要幾個小時才能發揮作用。所以恭喜你獲得這些數據。我的問題是，外科醫生歷來不願在手術環境中使用非類固醇抗發炎藥，因為會造成出血，您認為您的產品在急性情況下的使用情況與在使用美洛昔康治療關節炎等慢性情況下的使用情況如何？

Secondly, how do you think about potential risks with the [CMAX] because it definitely goes higher than the traditional meloxicam and if there's any potential bleeding risks. And finally, do you anticipate this being a hospital drug or not? Thank you.

其次，您如何看待 [CMAX] 的潛在風險，因為它的劑量肯定高於傳統的美洛昔康，以及是否有任何潛在的出血風險。最後，您是否預計這會成為一種醫院藥物？謝謝。

Thank you, Umar, for the questions, and nice to hear from you. The first one was relative to some facts around our US manufacturing network. We have 26 facilities in our network globally. We have eight facilities, manufacturing, packaging, R&D in the US. We manufacture approximately -- greater than 50% of our total revenues come from the US. The rest comes from combination of Ireland, the UK, and India. So that's a little bit of just a fact pattern of what our manufacturing footprint looks like. And obviously, given tariffs, we're looking at a number of short and long-term remediations if tariffs come and where they come from. So we're doing a lot of significant planning. We talk about it on a daily basis on things we can do to remediate, including taking a look at expanding our current US network, which again produces greater than 50% of our revenues.

謝謝你，Umar，提出這些問題，很高興收到你的回覆。第一個問題與我們的美國製造網絡的一些事實有關。我們的網路在全球擁有 26 個設施。我們在美國擁有八個工廠，包括製造、包裝和研發部門。我們的製造業大約有 50% 以上的總收入來自美國。其餘來自愛爾蘭、英國和印度。這只是我們製造足跡的事實模式。顯然，考慮到關稅，我們正在考慮如果徵收關稅以及關稅來自何處的一系列短期和長期補救措施。所以我們正在進行大量重要的規劃。我們每天都在討論可以採取的補救措施，包括考慮擴大我們目前的美國網絡，該網絡再次創造了我們 50% 以上的收入。

Yes, and I will cover the three questions, I believe, on meloxicam. First of all, so first about the surgery setting. We studied in three clinical trials, one Phase 2 in post-surgery dental pain, bunionectomy and herniorrhaphy post-surgery. And we've seen no increased risk of bleeding as part of these three studies in our clinical studies. As a matter of fact, the safety profile was very much consistent with placebo, so we saw no increased risk in this post-surgery population.

是的，我相信我會回答有關美洛昔康的三個問題。首先，先來了解一下手術環境。我們進行了三項臨床試驗，其中一項為第二階段試驗，研究的是術後牙痛、拇囊切除術和疝氣修補術。在我們的臨床研究中，這三項研究並未發現出血風險增加。事實上，其安全性與安慰劑非常一致，因此我們沒有發現術後族群的風險增加。

In terms of CMAX, you're correct. The CMAX is higher. However, as I just said, it did not lead to -- in an acute setting, lead to additional -- any additional risk of bleeding. We have not seen any of it in the Phase 2 and Phase 3 program. So to the last question about hospital drug, I'll give that to Corinne to answer.

就 CMAX 而言，您說得對。CMAX較高。但是，正如我剛才所說，在急性情況下，它不會導致任何額外的出血風險。我們在第二階段和第三階段的計畫中沒有看到任何相關內容。因此，關於醫院藥物的最後一個問題，我將交給 Corinne 來回答。

Yes, so we believe that this fast-acting meloxicam definitely could be used already in the hospital, as it was done in the clinical trial setting, but also, of course, for outpatient usage. And we're also looking at not only utilization of the product post-surgery, but also in any episode of acute care. And that could be dental acute pain or other type of acute pain, as we have also demonstrated very positive data in Phase 2 model in dental pain.

是的，所以我們相信這種速效美洛昔康肯定可以在醫院使用，因為它是在臨床試驗環境中進行的，當然也可以供門診使用。我們不僅關注該產品在術後的應用，還關注其在任何急性護理中的應用。這可能是牙科急性疼痛或其他類型的急性疼痛，因為我們在牙科疼痛的第 2 階段模型中也展示了非常積極的數據。

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

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

Thank you very much, Stuard. In closing, we've had a really good start to the year. We've got operational performance in line with our expectations, significant pipeline progress, continued capital and return to our shareholders. We remain very optimistic about the future of Viatris.

非常感謝，斯圖爾特。總而言之，今年我們有一個非常好的開始。我們的營運績效符合預期，管道進展顯著，資本持續流入並為股東帶來回報。我們對 Viatris 的未來仍然非常樂觀。

Our growing pipeline, capital discipline, operational excellence, and significant global scope give us confidence in our ability to navigate through periods of volatility and uncertainty that our industry has been experienced for much of the year.

我們不斷增長的產品線、資本紀律、卓越的營運以及廣泛的全球範圍使我們有信心度過本行業在今年大部分時間所經歷的波動和不確定時期。

Thank you all very much for your attention this morning.

非常感謝大家今天早上的關注。

Ladies and gentlemen, the conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.

女士們、先生們，會議現已結束。我們非常感謝您參加今天的演講。現在您可以斷開線路了。