Hội nghị công bố kết quả kinh doanh Q3 2026 của Viatris (VTRS): Nâng định hướng khi tăng trưởng tại Mỹ tăng tốc

Những điểm chính

• Viatris công bố doanh thu quý 3/2026 đạt 3,75 tỷ USD, EBITDA điều chỉnh đạt 1,2 tỷ USD và EPS điều chỉnh đạt 0,71 USD.
• Trong 9 tháng đầu năm 2026, doanh thu tăng 2%, EBITDA điều chỉnh tăng 6% và EPS điều chỉnh tăng 8% so với cùng kỳ năm trước trên cơ sở hoạt động.
• Doanh số tại khu vực Bắc Mỹ tăng khoảng 7%, được thúc đẩy bởi các loại thuốc generic phức tạp có biên lợi nhuận cao hơn và miếng dán Estradiol. Doanh số tại khu vực Đại Trung Hoa tăng khoảng 10%, dù những thay đổi trong chính sách đấu thầu mua sắm đã kìm hãm đà tăng trưởng.
• Ban lãnh đạo đã nâng mức trung vị trong dự báo cả năm 2026 đối với tất cả các chỉ số chính. Tại các mức trung vị điều chỉnh này, công ty kỳ vọng mức tăng trưởng hoạt động đạt khoảng 2% đối với doanh thu, 6% đối với EBITDA điều chỉnh và 8% đối với EPS điều chỉnh.
• Tình trạng hạn chế nguồn cung chủ yếu liên quan đến việc khắc phục tại nhà máy Nashik đã làm giảm khoảng 100 triệu USD doanh thu quý 3. Ban lãnh đạo dự kiến sẽ có thêm tác động khoảng 100 triệu USD nữa trong quý 4.
• Viatris dự kiến thương vụ mua lại Pacira BioSciences sẽ hoàn tất trước cuối tháng 11 và sẽ gia tăng giá trị ngay lập tức cho tất cả các chỉ số dự báo tài chính năm 2027 so với kết quả dự kiến của năm 2026.

Kết quả tài chính chủ chốt

Hiệu quả kinh doanh và hoạt động

Doanh số tại Bắc Mỹ tăng khoảng 7% so với cùng kỳ năm trước và vượt kỳ vọng của ban lãnh đạo. Tăng trưởng được dẫn dắt bởi các loại thuốc generic phức tạp có biên lợi nhuận cao hơn, bao gồm các sản phẩm miếng dán Estradiol, cùng các loại thuốc tiêm mới ra mắt gần đây. Sản lượng miếng dán Estradiol đã tăng gần gấp đôi so với cùng kỳ năm trước. Viatris đang mở rộng công suất sản xuất và đóng gói để đáp ứng nhu cầu.

Doanh số tại khu vực Đại Trung Hoa tăng khoảng 10%, với mức tăng trưởng trên tất cả các kênh và thương mại điện tử tiếp tục được áp dụng rộng rãi. Những thay đổi trong chính sách đấu thầu mua sắm tập trung vào bệnh viện đã bắt đầu làm chậm đà tăng trưởng, phù hợp với kỳ vọng của ban lãnh đạo.

Châu Âu và các thị trường mới nổi chịu ảnh hưởng bởi tình trạng hạn chế nguồn cung, chủ yếu liên quan đến việc khắc phục tại nhà máy Nashik. Theo ban lãnh đạo, nhu cầu cơ bản vẫn duy trì lành mạnh, với mức tăng trưởng tại các thị trường bao gồm Ý và Tây Ban Nha, cùng sự vững chắc liên tục của các thương hiệu lâu năm tại các thị trường mới nổi.

Tại Nhật Bản, các quy định kiểm soát giá đã lấn át mức đóng góp từ việc ra mắt Effexor. Ban lãnh đạo kỳ vọng Effexor, Spydia và việc ra mắt WAKIX đã được phê duyệt sẽ giúp định vị mảng kinh doanh này quay trở lại đà tăng trưởng.

Viatris đã ra mắt Gwyn Lo tại Mỹ vào tháng 10 và được Mỹ phê duyệt RYZUMVI cho tật lão thị. Công ty cho biết quá trình FDA xem xét meloxicam tác dụng nhanh về cơ bản đã hoàn tất, với các cuộc thảo luận về nhãn thuốc dự kiến sẽ diễn ra trước ngày PDUFA là 27/12 và khả năng ra mắt vào đầu năm 2027.

Kết quả Giai đoạn III của Cenerimod dự kiến sẽ có trước tiên vào nửa đầu năm 2027. Dữ liệu của Selatogrel cũng được kỳ vọng vào khoảng nửa đầu năm 2027, dù thời điểm này kém chính xác hơn do nghiên cứu dựa trên biến cố. Viatris cũng kỳ vọng sẽ có hơn 100 sản phẩm generic được phê duyệt trong năm 2026 và đang chuẩn bị ra mắt thuốc tiêm aripiprazole dùng một lần mỗi tháng tại Mỹ.

Dự báo của ban lãnh đạo

Tại mức trung vị của dự báo năm 2026 đã điều chỉnh, ban lãnh đạo kỳ vọng mức tăng trưởng hoạt động đạt khoảng 2% đối với tổng doanh thu, 6% đối với EBITDA điều chỉnh và 8% đối với EPS điều chỉnh so với năm 2025. Dự báo cập nhật này không bao gồm bất kỳ đóng góp nào từ thương vụ mua lại Pacira dự kiến.

Triển vọng quý 4 phản ánh đà tăng trưởng tiếp tục tại Mỹ, doanh thu từ các sản phẩm mới do octreotide dẫn dắt và nguồn cung miếng dán Estradiol tăng lên. Những lợi thế này dự kiến sẽ bị bù trừ một phần bởi sự cạnh tranh gia tăng, khoảng 100 triệu USD doanh thu bị gián đoạn do vấn đề nguồn cung tại châu Âu và các thị trường mới nổi, cùng các khoản đầu tư tăng thêm để hỗ trợ tăng trưởng tương lai.

Ban lãnh đạo dự kiến khu vực Đại Trung Hoa sẽ tiếp tục tăng trưởng trong quý 4, nhưng thấp hơn mức 10% ghi nhận trong quý 3 khi các chính sách đấu thầu mua sắm của bệnh viện mở rộng ra nhiều tỉnh thành. Bước sang năm 2027, công ty kỳ vọng mức tăng trưởng tại Trung Quốc sẽ tiến gần hơn về vùng lịch sử ở mức một con số từ thấp đến trung bình.

Viatris dự kiến giao dịch Pacira sẽ hoàn tất trước cuối tháng 11, được tài trợ bằng lượng tiền mặt thặng dư và các khoản vay ngắn hạn theo các hạn mức tín dụng hiện có. Ban lãnh đạo kỳ vọng tác động tối thiểu lên tỷ lệ đòn bẩy gộp và đạt được hơn 50 triệu USD hiệp lực chi phí hàng năm vào cuối năm 2028. Với các sản phẩm của Pacira, công ty dự kiến mảng Thuốc đổi mới sáng tạo tại Mỹ sẽ tạo ra hơn 1 tỷ USD doanh thu vào năm 2027.

Rủi ro và các yếu tố cần theo dõi

• FDA đã phân loại nhà máy Nashik vào diện Cần có hành động chính thức (Official Action Indicated) sau khi đưa ra các quan sát trong Mẫu 483. Viatris đã tạm ngừng sản xuất tại cơ sở này vào tháng 10 trong khi công tác khắc phục vẫn tiếp tục.
• Tăng trưởng tại Trung Quốc dự kiến sẽ chậm lại khi các chính sách đấu thầu mua sắm tập trung vào bệnh viện được triển khai, với thời điểm và mức độ thực thi khác nhau tùy theo từng tỉnh.
• Ban lãnh đạo chỉ ra sự cạnh tranh gia tăng đối với một số sản phẩm và áp lực hết hạn độc quyền dự kiến, bao gồm khả năng mất quyền độc quyền vào giữa năm 2027 đối với Amitiza tại Nhật Bản và tác động cả năm 2027 từ Isosulfan blue.
• EXPAREL phải đối mặt với sự gia nhập của thuốc generic bị giới hạn sản lượng vào năm 2030. Viatris cho biết các giả định của công ty không phụ thuộc vào việc các nhà sản xuất thuốc generic gặp khó khăn trong sản xuất.
• Thời điểm công bố kết quả Giai đoạn III của Selatogrel vẫn phụ thuộc vào thiết kế nghiên cứu dựa trên biến cố.

Điểm nhấn phiên hỏi đáp với chuyên gia phân tích

Ban lãnh đạo cho biết danh mục sản phẩm tại Mỹ đang chuyển dịch sang các loại thuốc generic phức tạp bền vững hơn và có biên lợi nhuận cao hơn. Đến cuối năm, Viatris dự kiến sẽ có 8 loại thuốc tiêm phức tạp, 2 loại thuốc hô hấp và 3 sản phẩm dán qua da chủ chốt được phê duyệt.

Đối với miếng dán Estradiol, công ty kỳ vọng nhu cầu sẽ tiếp tục tăng và coi danh mục này là động lực tăng trưởng quan trọng ít nhất cho đến năm 2030. Ban lãnh đạo cho biết các miếng dán của công ty dự kiến sẽ tiếp cận 1,5 triệu phụ nữ vào năm 2026, và thêm 1 triệu người dùng nữa vào năm 2027.

Khi được hỏi liệu EBITDA điều chỉnh có thể tiệm cận mức 5 tỷ USD ngay từ năm 2027 hay không, ban lãnh đạo từ chối đưa ra dự báo nhưng cho biết mức này nằm trong phạm vi kịch bản khả thi nói chung dựa trên đà phát triển kinh doanh và thương vụ mua lại Pacira dự kiến.

Đối với EXPAREL, ban lãnh đạo kỳ vọng mức tăng trưởng sẽ tiếp tục trước khi thuốc generic bị giới hạn sản lượng gia nhập thị trường vào năm 2030. Viatris cũng có kế hoạch áp dụng các năng lực sở hữu trí tuệ và quản lý vòng đời sản phẩm sau khi thương vụ mua lại hoàn tất.

Ban lãnh đạo cho biết cơ sở hạ tầng thương mại của Pacira tại các bệnh viện, trung tâm phẫu thuật ngoại trú và các cơ sở bán lẻ có thể hỗ trợ việc ra mắt meloxicam tác dụng nhanh. Các quyết định định giá cuối cùng sẽ phụ thuộc vào nhãn thuốc được phê duyệt.

Viatris vẫn duy trì các ưu tiên phân bổ vốn: cổ tức, mua lại cổ phiếu theo cơ hội và phát triển kinh doanh. Công ty cho biết họ dự kiến sẽ tạo ra đủ tiền mặt để thực hiện cả ba ưu tiên này cho đến năm 2030.

Toàn văn biên bản cuộc họp công bố kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good morning, and welcome to the Viatris Q3 2026 Earnings Call. [Operator Instructions]

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

William Szablewski

Good morning, everyone. Welcome to our Q3 2026 earnings call. With us today is our CEO, Scott Smith, Interim CFO, Paul Campbell; 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 2026, and in various strategic initiatives. These statements are subject to risks and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to the most directly comparable GAAP measures.

When discussing 2026 actual reported results, we'll be making certain comparisons to 2025 actual or reported results on an operational basis, which excludes the impact of foreign currency rates. When comparing our 2026 actual reported results to our expectations, we are making comparisons to 2026 financial guidance.

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

Scott Smith

Good morning, everyone. We're pleased with our strong third quarter performance, which reflects continued momentum across our businesses. As we've been saying, we believe we've entered a new phase of sustained growth for Viatris. The disciplined execution of the strategy we outlined earlier this year is translating into results. During the third quarter, we delivered total revenues of $3.75 billion, adjusted EBITDA of $1.2 billion and adjusted EPS of $0.71 per share. Through the first 9 months of the year, total revenues grew 2%, adjusted EBITDA grew 6% and adjusted EPS grew 8% operationally compared to the prior year, demonstrating continued progress towards our long-term financial targets.

Given our performance and expectations for continued momentum in the fourth quarter, we are narrowing our financial guidance ranges and once again raising the midpoint for all key financial metrics. Paul will provide more details shortly.

Now let me walk through a few highlights for the quarter. Our base business continues to deliver solid results, reflecting the strength and durability of our portfolio. We're pleased with our performance in North America and Greater China, where we continue to see meaningful growth. In North America, growth is accelerating as our portfolio mix shifts towards more durable, higher-margin products in complex generics, supported by strong demand for our Estradiol patches and new product revenue from our recent injectable launches. We are pleased to have launched Gwyn Lo, our low-dose contraceptive patch in the U.S. in October. In Greater China, growth continues to be driven by strong demand for our cardiovascular portfolio and the strength of our established brands.

Regarding our pipeline, we continue to make meaningful progress in advancing our innovative medicines portfolio and positioning the business for long-term growth. In Japan, we received regulatory approval for WAKIX which we expect to be an important product launch, a key contributor to the country's strategy to return to growth. In the U.S., we received approval for RYZUMVI for the treatment of presbyopia, and we continue to advance our preparations for the potential approval and launch of fast-acting meloxicam. As a reminder, -- the PDUFA date for fast-acting meloxicam is December '27. And if approved, we expect to launch early in 2027.

In addition, we are approaching the Phase III readouts for Selatogrel and Cenerimod, representing significant milestones for Innovative Medicines portfolio. Both products have blockbuster potential could become an important growth drivers for us in the next decade. Philippe will provide additional details on these programs and the pipeline shortly.

Finally, I'd like to take a moment to discuss our recently announced agreement to acquire Pacira BioSciences and the strategic opportunities we believe this transaction will create for Viatris. I'm excited about the potential of the Pacira business. I believe this acquisition represents a significant step forward for Viatris and is a strong example of the business development strategy we are executing to support our long-term growth. More specifically, the transaction would add 2 established patent-protected medicines in the U.S., EXPAREL and ZILRETTA further strengthening our U.S. Promoter Brands business with durable revenue and margins well above our company average.

With the addition of Pacira's products, we expect our U.S. Innovative Medicines business to generate more than $1 billion in total revenue in 2027. We're also exploring potential opportunities to leverage our global infrastructure to develop and commercialize Pacira's products in selected markets outside of the U.S. Additionally, Pacira would bring an experienced U.S. team and established capabilities across sales, marketing, market access, medical affairs and global R&D that complement our existing infrastructure. We believe these capabilities can help us maximize the potential of fast-acting meloxicam and position Viatris to become a leader in non-opioid pain management.

Before I turn it over to Philippe, I want to recognize a recent leadership transition. After more than 30 years with Viatris and our legacy companies, Peter McCormick retired as our Chief Supply Officer on November 1. I want to personally thank Peter for his tremendous contribution and years of dedicated leadership. With Peter's transition, I'm very pleased to welcome Paul Duffy, as our new Chief Supply Officer. Paul brings 35 years of industry experience across global supply chain management, manufacturing, strategy and business transformation. I'm looking forward to working very closely with him.

With that, I'll turn it over to Philippe. Philippe.?

Philippe Martin

Thank you, Scott. We continue to execute with discipline across our pipeline and remain on track to deliver against our R&D priorities. Starting with our value-added medicines. The FDA review of our fast-acting meloxicam NDA is substantially complete with FDA being very engaged with us throughout the review process. We are on track to start labeling negotiations this month ahead of an anticipated regulatory decision by our PDUFA date of December '27. We continue to view fast-acting meloxicam as a potentially meaningful addition to the acute pain treatment landscape given its rapid absorption profile, clinically meaningful pain relief and demonstrated reduction in opioid use.

Over the past 2 years, we've been working on bringing additional benefits to patients through life cycle management opportunities, including label expansion or additional indications. To this end, we recently secured on-time approval for the presbyopia indication for RYZUMVI in the U.S. We also submitted a type 2 variation application in Europe for Creon to expand its approved dosing range for noncystic fibrosis indications, which represents a significant opportunity to expand the value of these important products for patients. We anticipate a regulatory decision in the first half of 2027.

Regarding our women's health portfolio, we continue to leverage our transdermal capabilities to address important unmet needs. We have received approval and launched Gwyn Lo in the U.S. and continue to advance our next patch candidate in Norelgestromin-only weekly patch, for which we have completed Phase III enrollment and anticipate a data readout in the first half of 2027. In Japan, our Nefecon program for patients with IgA nephropathy continue to advance as planned following the positive Phase III results announced earlier this year. We remain on track to submit our JNDA by the end of this year with a regulatory decision anticipated in the second half of 2027.

Turning to our innovative pipeline. Cenerimod continues to progress well with both Phase III SLE studies of OPUS-1 and OPUS-2 advancing as planned. We remain on track to report results in the first half of 2027. In addition, the Phase III LUMIOS study in lupus nephritis is actively enrolling patients. For Selatogrel, enrollment in our SOS-AMI Phase III studies continues to track well. We continue to expect a data readout around the first half of 2027, keeping in mind the event-driven design of the study.

Turning to our generic pipeline, where our execution remains strong. We are on track to secure over 100 new product approval this year, reflecting the strength and breadth of our development and regulatory capabilities. Importantly, we are preparing to launch our once-monthly aripiprazole injection in the U.S. for which we were the first to secure final FDA approval. In addition, we have secured first to trial status for Wegovy of semaglutide 25-milligram tablets, further strengthening our pipeline of generic GLP-1s.

Lastly, with the announced acquisition of Pacira, we see an opportunity to bolster our global R&D platform with new talent capabilities and programs. There are several pipeline programs of interest for which there are upcoming readouts including the Phase II Part A readout for the osteoarthritis gene therapy asset PCRX-201. We will make sure to keep you updated on the status of this program following deal close.

Overall, we expect a strong finish to the year and believe we are well positioned heading into 2027 with several important regulatory and clinical milestones across our innovative value-added and generic pipeline.

With that, I'll turn the call over to Paul. .

Paul Campbell

Thank you, Philippe, and good morning, everyone. As a quick summary, we delivered another strong quarter of performance, driven primarily by continued growth in our higher-margin Greater China and North American businesses which offset ongoing supply constraints affecting lower-margin generics performance in Europe and emerging markets. While the overall impact on total revenues was neutral. Adjusted EBITDA benefited from the higher net margins. Today, I will review the key drivers of our third quarter performance discuss our updated financial outlook for the remainder of the year and highlight some expected benefits associated with our proposed acquisition of Pacira BioSciences.

Beginning with our third quarter results. total revenues were $3.75 billion, in line with expectations. This performance reflects the continued strength of our global base business, the breadth of our diversified portfolio and disciplined execution. More specifically, Greater China continues to benefit from favorable macroeconomic and demographic trends, strong demand from our leading portfolio of established brands and continued execution from our commercial organization. During the quarter, Greater China net sales grew approximately 10% versus the prior year, driven by growth across all channels, including continued uptake in the e-commerce channel. Also, as anticipated, the policy changes we discussed last quarter began to moderate our growth, particularly in the hospital channel.

As such, net sales were in line with our expectations for the quarter. In North America, we are really encouraged by the growth of our U.S. business. Growing our business in the U.S. remains a strategic priority and is expected to be an important driver of our future growth and success. Throughout the year, we have continued to capitalize on favorable market dynamics across certain key products. In the third quarter, North America net sales exceeded our expectations and grew approximately 7% versus the prior year driven primarily by growth of higher-margin complex generics, including Estradiol patch products. In fact, these drivers represented over 65% of our North American generic net sales for the quarter, reflecting our continued shift away from commodity generics.

Specifically related to our Estradiol patch products, net sales in the quarter for North America exceeded our expectations, with volumes approximately double compared to the prior year period. We have actively expanded capacity through operational enhancements and expect to continue to make additional capital investments across our manufacturing and packaging operations for future expansion. These actions will position us to better serve increasing patient demand. Within Europe and emerging markets, performance was impacted by continued supply constraints, primarily related to remediation activities at our Nashik facility.

The total revenue impact of those supply constraints was approximately $100 million in the third quarter. Specific to an update on Nashik, in September, the company received notice from the FDA that the plant was being classified as official action indicated or OAI following the issuance of 483 observations in May. In October, out of an abundance of caution, we suspended manufacturing the facility while remediation activities are ongoing. It is important to note that underlying demand trends across both regions generally remain healthy. This is demonstrated by growth in key European markets such as Italy and Spain, as well as continued strength in our established brands portfolio in emerging markets.

Within gens, net sales exceeded our expectations but declined versus the prior year reflecting the impact from government price regulations, which more than offset the positive contribution from the launch of Effexor for generalized anxiety disorder. We are encouraged by the early uptake of Effexor and continue to believe this launch, combined with the continued uptake of Spydia and the expected launch of WAKIX positions Japan for a return to growth in the future.

Turning to the remainder of the P&L. Adjusted gross margins came in above our expectations at 58%, driven by the growth in Greater China and North America. Operating expenses were in line with expectations and declined slightly as a percentage of total revenues compared with the prior year, reflecting continued spending discipline and the benefits from our enterprise-wide strategic review. We remain on track to achieve $120 million of net savings from the strategic review this year. Collectively, these factors contributed to improved operating leverage across our businesses.

Now turning to cash flow. Free cash flow was $814 million during the quarter, inclusive of transaction and restructuring-related costs and taxes exceeding our expectations. Excluding these items, free cash flow would have been $895 million. Through the first 3 quarters, we returned approximately $717 million of capital to shareholders through $300 million of share repurchases and the remainder coming from the quarterly dividends. And lastly, we exited the quarter in a strong gross leverage position at approximately 2.9x and which is below the midpoint of our long-term target of 2.8 to 3.2x.

Now let me provide a full year financial guidance update. Based on strong performance year-to-date and our confidence in the continued momentum of the business, we are raising our 2026 financial guidance across all key metrics. It is important to note that this updated guidance excludes any contributions from the proposed acquisition of Pacira. At the midpoint of our revised guidance ranges, we now expect operational growth of approximately 2% for total revenues; 6% for adjusted EBITDA and 8% for adjusted EPS versus the prior year. Our outlook reflects a balanced view of fourth quarter dynamics as we currently see them, including continuing strength in the U.S., including new product revenue, led by octreotide and increasing supply for our Estradiol patch products, partially offset by additional competition on certain key products.

Continuing growth in Greater China, but moderated by the implementation of a hospital focus procurement policy, continuing supply disruptions expected to impact Europe and emerging markets total revenues by approximately $100 million in the fourth quarter and increasing investments to support future growth. As we approach year-end, we remain confident in our expectation to continue growing our globally diversified business into 2027. Lastly, I want to spend a few minutes discussing Pacira. The tender offer was launched on October 30, and we expect the transaction to close before the end of November. We expect the impact of the transaction to be immediately accretive to all financial guidance metrics in 2027 versus our expected 2026 results. Also, the transaction is expected to be funded from excess cash and short-term borrowings from existing credit facilities. As such, we expect the transaction to have a minimal impact on our gross leverage ratio.

In addition, we are enthusiastic about Pacira's ability to accelerate our innovative medicine strategy and we see the following additional potential benefits of the transaction. Expected growth across total revenues and adjusted EBITDA meaningfully contributes towards achievement of our stated long-term growth targets. By combining both businesses, we currently expect to realize more than $50 million in annual cost synergies by the end of 2028 with the potential for additional savings as we fully integrate the business. Ability to leverage Pacira's commercial capabilities expertise in acute non-opioid pain management to maximize the potential of fast-acting meloxicam.

Ability to leverage our proven expertise across intellectual property and extend product life cycles to maximize the long-term value of the Pacira portfolio and strengthening our cash flow generation credit profile and preserving financial flexibility. In closing, we remain focused on executing on our strategy to accelerate growth generate strong cash flow, maintain a balanced and disciplined approach to capital allocation and deliver long-term value for patients, customers and shareholders.

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

Operator

[Operator Instructions]

Our first question today comes from [ Les Sulewski ] from Oppenheimer. .

Phần hỏi đáp

Unknown Analyst

Congrats on the progress. So first, you previously noted hospital procurement changes would moderate China growth, but with 10% in 3Q, as the policy impact smaller or is it being offset by stronger demand? And as a follow-up, how much of the updated guidance comes from puts and takes around the performance, specifically in China versus the rest of the portfolio? And how is your outlook for ex China changed?

Scott Smith

Yes. So first of all, thank you for the questions. China specific, we're very, very pleased with the progress that we're making in China with the investments that we've made we see some policy implementation in China, but we still see very, very good momentum as we go through the year. We expect that to continue as we get into 2017 and beyond. I think we're kind of uniquely well positioned given the brands that we have, the investments that we've made in certain channels in China and the overall dynamics of the -- and the quality of the affiliate that we have in China. I think we're very well positioned to finish the year strong and move into '27 with momentum.

I'll turn it over to Paul to give more specific on some of the questions you asked.

Paul Campbell

Okay. Thanks, Scott. Les, so just to add to what Scott said, the impact for the quarter was in line with our expectations. I think back -- in the second quarter, we had talked about the moderating growth. First half of the year, our growth was 16%, 17%; in the third quarter, it was 10% year-over-year. So it did moderate to a level that we expected. We currently are seeing some variability in the level of readiness and enforcement of the policy across provinces, which is really preventing us from being precise on what we think the impact is. But as we look into Q4, consistent with what we said last quarter, we expect Q4 to be a higher impact than Q3 as other provinces come online. So the way I'm thinking about it is the growth rate continue to come down, I believe, below the 10% that we had in Q3, but still very, very healthy in Q4.

And then more importantly, as we exit the year and go into '27, we still see growth coming from China next year, albeit closer to the historical averages we've had more in the low to middle mid-single-digit range, but very excited about that business.

Scott Smith

No, and Les you asked a little bit about ex China. And just 1 thing I'd like to point out is the mix evolution that we're seeing in the United States moving towards more complex, higher-margin products. We -- by the time we get to the end of the year, we will have 8 complex injectables approved; 2 respiratory medicines, 3 HR key transdermals. And so we're really working hard to evolve the portfolio in the U.S. towards higher margin, higher growth stickier revenue complex generics. So we're also very pleased with how we're tracking there.

Operator

Our next question comes from Glen Santangelo from Barclays.

Glen Santangelo

Scott, maybe I could just follow up on Les' question a little bit. I wanted to zoom out -- and just sort of look at the growth so far year-to-date, I think now you're -- with the guidance raise, you're sort of calling for 2% revenue growth. And if you go back to your Analyst Day back in March, I think you were sort of comfortable at the time with that 2% to 3% sort of base business growth. And when you look at the year, certainly some things played out maybe better than you would have expected like China, maybe some of the value-added launches clearly, on the women's health side, but you also had the facility fire maybe on the negative side. Can you just maybe just give us a little bit of a postmortem on this year and some of those bigger highlights and what went better and maybe more importantly, what didn't play out like you thought as we think about the exit rate here in '26 heading into 2027.

I know you don't want to give guidance, but I'm just kind of curious if you feel better about your base business today heading into the new year? And then my second question was for Philippe, and I apologize if I missed this in your prepared remarks, but I just want to make sure I'm clear on the timing of the readouts for Selatogrel and Cenerimod in '27 and any high-level expectations you might have there .

Scott Smith

Thanks, Glen. I'll take couple of comments, kick it over to Paul and then to Philippe to answer your questions. We're very, very pleased with the momentum that we have so far this year. If you take a look at the first 9 months of the year, 2% revenue growth, a little bit above that as we talked about 6% EBITDA growth. 8% EPS growth relative to prior year. So we're very, very pleased with the progress that we're making towards the goals that we put out earlier this year. Also when you add Pacira and hopefully, we'll get that acquisition close, and you take a look at '27. Our U.S. Innovative Medicines business will be over $1 billion in '27 likely. And so we're very, very pleased with the progress we're making on the base business overall, adding some interesting innovative components in the U.S. seeing good progress in China, a lot of launches in Japan. I think overall, we're very pleased with the momentum we've got in '26 and where we're heading company-wide and with the portfolio, in particular as we move in '27. Paul?

Paul Campbell

Yes. Thanks, Scott. And thanks for the question, Glen. So if I go back to the beginning of the year, when you look at our original guidance, we had guided to about a 3% increase on an operational basis. And first half of the year, we outperformed that, right? But we had guided in the second quarter that we were going to have the headwinds, specifically related to the supply issues we were having primarily in Nashik. So if I think about where we were just from a regional or a country-specific place at the beginning of the year, right, we thought North America would be flat. Europe would be up 4%. And emerging markets up 6% and JANZ down 7% and Greater China up 3%, right? That was the guidance we provided.

With the midpoint of our updated guidance, we're now seeing -- because of some of the strengths that Scott is really focused on. North America, we expect to be more in the high single-digit range. We see Europe coming in flattish, primarily related to the supply, but there are some other dynamics in the business competition we had talked about on some of our products that are also putting pressure there. Emerging markets and JANZ are going to be low single-digit declines now. Again, emerging markets would be supply-related. And Greater China, we're looking at coming in closer to kind of the low double-digit range as the moderation hits Q4, but with the strength of the first half we see.

So as we look forward to '27 and I want to really emphasize what Scott's been saying. We are very encouraged and very confident in the business as we look into '27. We're hoping to continue the growth in North America. We haven't talked a lot about the Estradiol Patch products, but we do see continuing demand there where -- as that grows into '27 there's a mix -- a positive mix impact to adjusted EBITDA. China, as I mentioned before, we expect some growth to continue there, although back to historical levels. And then obviously, the Pacira business will come online. We also have exciting product launches for next year. Gwyn Lo, we've launched and it just launched in October, just started, and we're hoping to get approval for fast-acting meloxicam and have that on the market next year.

So a lot of great momentum as we go into '27. The 1 item I would just point out, to keep in mind that we're keeping an eye on is we do have some loss of exclusivities next year, particularly Amitiza, we expect or if there's a potential to lose that midyear in Japan. And then Isosulfan blue is another good product in the U.S. that lost LOE this year. We're going to have a full year impact next year. So there are a few kind of headwinds there, but I think the -- I mean, the tailwinds certainly are in our favor overall.

Scott Smith

And Philippe, there's a lot of [indiscernible]

Philippe Martin

Yes. So Selatogrel and Cenerimod are continuing to perform. The study is perform as planned, as expected. We're going to get the results for Cenerimod first. It will be in the first half of '27, followed by Selatogrel also expected in the first half of 2027. It's an event-driven study. So the precision there is less than for Cenerimod, but based on what we're seeing today, that's our expectation to get that data around the first half 2027. So the studies are performing as expected, nothing to point out that is not going in the right direction at this point. And so we look forward to seeing those results early next year.

Operator

Our next question comes from Ash Verma from UBS. .

Ashwani Verma

Great. Congrats on the Pacira deal that you're going to close soon. Maybe just on the Exparel generic entry in 2030. So I wanted to get your thoughts on the potential entry of Fresenius generic. There was a settlement for this for limited volume in 2025. But since then, the patent estate is expanded, plus Pacira talked about this [indiscernible] hearing and trial coming up. So just help us understand that this product can have a durable growth beyond 2030. And then secondly, I wanted to ask about women's patches. So it seems like pretty significant growth year-over-year, and you're seeing roughly $700 million to $800 million in gross sales, annualized run rate in IQVIA. How much of net sales are you generating. It seems like a pretty big category, and you are the leader in this space. Just how big can it get from here for you?

Scott Smith

Yes. So very much. I'll kick it over to Paul to talk a little bit about the cadence of genericization and exclusivity that we're thinking around EXPAREL. And I can come back to you talk a little bit about the transdermal market and the evolution that we've seen there.

Paul Campbell

Sure. Thanks. So as far as Pacira goes, we obviously did our diligence with the company. And I would say, number one, from now until 2030, we do expect continued growth in EXPAREL until the volume-limited generic entry in '30. We also believe 1 of the benefits of the transaction was bringing our proven ability to extend product lifestyle, life cycles and sustain meaningful sales after generic entry. So we're hoping to maximize the long-term value of EXPAREL post 2030. And I also think it's important, I think that Pacira has talked about this since the original settlement that they entered into. There has been a lot of work done around the IP for that product and additional patents that are out there, et cetera. And so we're very encouraged by that, and we'll obviously work once we take over the company to defend that position vigorously.

Scott Smith

Yes. And relative to the HRT market the transdermal market, we've seen sort of over the last 12 to 18 months, an unexpected increase in demand for those products based on a removal of black box warning on HRT. Also the utilization of GLP-1 products increasing overall delayed gastric emptying, making transdermal products much more favorable in the marketplace. And I think 1 of the things we've done is really hard to try and meet that demand. I've been to the plant personally. Everybody here in this room has been the plant some multiple times, we're trying to look for solutions. We've moved from 24/5 to 24/7 utilization of that plant. We're adding a packaging line. We're looking for geographic expansion outside of Vermont to other sites to be able to to meet the demand.

So we see an incredible demand. We've got market-leading products in this area, and we're doing everything we can to increase our supply to help meet that demand overall. I don't know, Corinne, did you want to add.

Corinne Le Goff

Just want to -- I was also at the plant last week and it's extraordinary to see the technicity of this plant. And we've been producing patches for decades, and we are really 1 of the leaders in this area. But the question I want to add on the market itself we see that the demand for our Estradiol patches will continue to increase into the foreseeable future. Just to give you an idea of how this market is developing, we have in the U.S., an estimated number of 45 million women that are asymptomatic with menopausal symptoms. But only I would say less than 30% of them are actually treated with HRT therapy.

So there is a very large untapped market and as part of our market research that we conducted with clinicians, we are seeing a very strong winning best to continue to treat these patients as the FDA, as Scott mentioned, has eliminated the black box warning for this product. So we are very optimistic for it on the outlook.

Scott Smith

And we'll continue to invest. We see this as being an important growth driver for the company between now and 2030 at least. And so we're going to take advantage of this increasing demand, make the right investments and continue to be a leader in the space.

Operator

And our next question comes from Umer Raffat from Evercore. .

Umer Raffat

Okay. I just wanted to touch up on 2 topics, if I may. First, -- there's obviously a lot of momentum in the base business off of several markets that are accelerating in U.S. as well as the broader business. When I add that ongoing momentum into '27 and layer on to it, some of the EBITDA synergies off of Pacira as well, -- is there a possibility that a $5 billion EBITDA is within reach for as early as 2027, not 2030, which is sort of where estimates currently stands.

Secondly, as I think about the upcoming readout for Cenerimod in lupus setting, I just wanted to check 2 things. One, the potential for potential for pooled analysis in interferon high Signature Group, -- is that prespecified? Or is that something you're going to have to discuss with the FDA only ask because once it's been unblinded, it may not be as easy to do. And also what constitutes interferon high gene -- because I remember the Phase II post-hoc used, I think, 4 or 5 genes in the signature, whereas a lot of the other companies have used a 3 signature panel. So are you -- have you specified what that interferon hygiene signature definition comprises .

Scott Smith

So First of all, from an EBITDA perspective, if you take a look at the momentum in the business and Pacira and other things, we're not going to guide '27 here at all. But what you're talking about the numbers you're talking about are certainly in the ballpark of where we may be going. I think we're making tremendous progress relative to those 2030 targets. And hopefully, we'll be able to hit them well ahead of time. So again, you're thinking in the ballpark, I think here, we don't want to guide '27 until we get through the year, obviously, and look at all the puts and takes and what's going into the year. But given the momentum and given Pacira and given some of those things going on, I think you're in the relative neighborhood. Philippe?

Philippe Martin

Yes. So the 2 questions on Cenerimod. So yes, the pooled analysis is prespecified as part of the SAP. Again, there's a number of end points that are particular relevance for this pooling strategy, in particular around opiosteroid sparing where pulling the 2 study together may help give us enough of a sample size to be fully powered for the analysis. So -- but all endpoints will be looked at as each individual study, but also as pool study, as you pointed out, these 2 studies are identical and can be pulled together.

In terms of the interferon in high, I think the -- there are different techniques to look at and classify interferon-1, they all lead to the same results, however. And so whether you pull 2, 3, 4 different type of genes together when we look at retrospectively, when we look at the data, it leads to the same results of those interferon 1 versus high versus who's not. So those techniques do not make a difference. At the end of the day, we the Phase II B care data to determine the cutoff. It is -- clearly, there's a separation between interferon-1 high and interferon-1 low patient based on that cutoff. So we do not anticipate to miss many patients that would be interferon 1 low but potentially responders.

So the short answer is that no matter how no matter which technique you use to the terminate interferon-1 high, it leads to similar results.

Operator

Our next question comes from Matt Dellatorre from Goldman Sachs.

Unknown Analyst

This is Tommy on for Matt. Just a couple on the upcoming pain launch. Maybe could you speak to how hospital purchasing dynamics in ambulatory surgical centers are evolving under the NOPAIN Act? Are there any clear volume shift towards non-opioid protocols? And how would this impact your pricing and loan strategy? .

Scott Smith

Good. So thank you for the question. I turn it over to Corinne for more detailed response.

Corinne Le Goff

Right. So thank you very much for your question. So for tasking meloxicam, of course, we fight for NOPAIN. I think what's important to note here is that NOPAIN has an impact and is very beneficial for a inpatient hospital patients, right. But our strategy with fast acting meloxicam is to really focus on the outpatient selling more of the retail settings. Of course, we're going to focus on postoperative pain, but mostly in the outpatient setting and as well as nonoperative pain. So that's now NOPAIN is important, and we are focused on this as well. .

Scott Smith

And to answer your question on pricing, we're obviously exploring a bunch of different pricing models, looking at a number of different pricing points, matching them up with strategy to get early penetration into the marketplace. But we don't make any final pricing decisions to we understand the fullness of the label and all the specifics around the label. So we're working on that. We're not in a position to get too specific until we see final label and make some final decisions on that case.

Corinne Le Goff

Would be [ enough ] of launches.

Operator

Our next question comes from Jason Gerberry from Bank of America. .

Jason Gerberry

Follow-up on Ash's question, a slightly different variant of it. Pacira in the past had talked about the manufacturing barriers to EXPAREL and wondering if that's part of the thought process here that there could be an upside that the generic suppliers may struggle to be able to make this. I assume that this is something that you guys looked at on the ANDA side of your business for a while. So just curious if you could comment on that.

And then my second question on Selatogrel is a commercial one, which is as we think about how you model the EpiPen business, right, and how patients stockpile a rescue option there, how are you modeling the rescue carry rates for something like AMI? I know in the past, you've talked about, I think, 20% of heart attack survivors have another event, but that could vary, right, a year to 5 years later. And so I'm just wondering how you model that and thinking about the importance of high-risk subgroups when we ultimately get detailed data, how that could play into the commercial use case? .

Scott Smith

Paul, do you want to comment on the Pacira [indiscernible] manufacturer and the barriers that presents? .

Paul Campbell

Yes. Yes. Thanks, Jason. Yes, absolutely, -- that product is very difficult to manufacture, and did look at it as we were working through diligence. I will say, as of now, there's -- we're not counting on any issues that generics may have. However, we are very aware that the product is tough to make and is something that could potentially be upside in the future. But certainly, we're not going to rely on that. We're going to assume if somebody has approval that they'll be able to manufacture and deliver the volumes that are expected. .

Jason Gerberry

I think these are difficult to make it difficult to get approval as well because showing sameness is difficult for these products. So not every generic companies will be able to make -- to get it approved and make a product like this. On the Cenerimod question, I think the way we're looking at the plan is that we'll get a shelf life that will be anywhere around between close to 2 years but that will require basically a new pen close to once a year for patients. So patients will have to renew their pen or pens every year. I think if you look at the dynamics we see for other emergency treatment, patients typically need more than 1 pen. They need 2 to 3 pens at 1 time. So I think we are -- that's part of the expectation we're going to need for Selatogrel. Anything else on that topic, you want to bring Corinne?

Corinne Le Goff

I'm going to add a point on the value of Selatogrel. Your [indiscernible] EpiPen might not apply here because the cable context and the value drivers are vastly different for Selatogrel -- - the cardiovascular outcome benefit that we expect and that we would consider as part of the value proposition of the product. So we will establish an EBITDA base value framework that would be linked to the reduction of the severity of the outcome, and we will be able to measure as part of our values, the measurable health care system efficiencies that will be driven by the early administration of Selatogrel. .

Scott Smith

You make an interesting point on the number of devices that an individual will accumulate over a lifetime. And I had a -- just a personal story at a near anaphylactic near fatal anaphylactic reaction in my mid-30s, and I probably own 50 EpiPens to this point. So modeling that gets very difficult, and the average patient certainly won't own 50%. But just particularly with something as serious as anaphylaxis or in this case, acute MI. Patients and the some quality of life data that we're going to be talking about coming out, patients feel much better to be able to have a device that they can take positive action if they have another event.

We're working on all these models, a lot of patients will have more than 1 device, someone in the car, other things. and then you need to renew the device over time. And again, I've never even had a second anaphylactic reaction myself, but I still have owned 40 to 50 EpiPens during the course of the last 30 years.

Philippe Martin

I think the other point to highlight is the fact that the risk of recurring MI is much higher within the first 6 months of the first MI, but it doesn't go away, right? So it stays over time. So the need to carry the pen doesn't go away 5, 6, 10 years post the first MI, right? So that's also data that will be emphasizing as we get closer to launch.

Operator

[Operator Instructions]

Our next question comes from David Amsellem from Piper Sandler. .

David Amsellem

Got a couple of EXPAREL related questions and just Pacira questions in general. So on EXPAREL, I mean, it's had a more mature growth trajectory in recent years. And obviously, the hospital environment can be challenging. So I guess what gives you confidence that you can grow the product significantly in the next few years before you start to see the volume limited generic competition. So that's number one.

And then secondly, on the pipeline from Pacira PCRX 2002, the ropivacaine product, I know that's Phase II ready. I'm just wondering how you're thinking about that asset as a potential next-generation postsurgical pain product that potentially could be a replacement for EXPAREL or even a better version that has longer lasting effects. And what's the extent to which you're ascribing value to that asset and your level of excitement over it.

Scott Smith

So David, thank you very much for the questions. We don't own Pacira at this point in time nor do we own EXPAREL. I'm not going to get into specific strategies in which we want to employ to change the trajectory of that growth line and the thing that we appropriate at this point in time. However, we have looked very, very deeply at the product. We think there are things that we can do to continue the growth rate, see less -- not as much of a mature growth rate, but continue to expand that growth rate and do some things to really sort of accelerate the EXPAREL growth over the next few years. We feel very confident in that. I don't want to get into specifics at all. I think 1 of the other things which is underestimated is the positive synergy of this transaction on fast acting and meloxicam, non-opioid pain very experienced group doing very well with the products with both products, ZILRETTA and EXPAREL.

And I think they have some capabilities. For me, the acquisition was not just about 2 important assets in EXPAREL ZILRETTA that are in the market accretive, growing, high margin, but also the capabilities that we're acquiring when we bring the group into our group. We're very, very excited about Pacira the capabilities that they bring and the ability of them to help us really launch fast acting meloxicam in a better way.

Corinne Le Goff

And really help us reach our potential with fast acting meloxicam. I think we are very impressed with the infrastructure that they have in the United States, their ability to reach hospitals -- ASCs and computer surgical centers, but also having software in retail as well. So it's a very strong addition for us, and that will accelerate our capabilities as we prepare for the launch of fast acting meloxicam.

Scott Smith

Pipeline question, Philippe? .

Philippe Martin

Yes. From 2002, your question, I think, again, we don't own these assets yet, but we certainly had due diligence around them. The pipeline was not the main driver for this acquisition. That being said, I think there is a number of assets within that pipeline that are very interesting and have put significant potential. You asked specifically about 2002. I think we see it as interesting because of the hydrogen technology and the long release time much longer effect than potentially than existing drugs on the market and also around the ease of administration, I think, is particularly important for this product.

Now it's early Phase 2 is just starting. So once we get the data, we'll revisit everything, right? But we'll make decision based on data going forward for this pipeline. And so once that data comes in, we'll get a better sense of the potential for these assets specifically.

Operator

Our next question comes from Chris Schott from JPMorgan. .

Unknown Analyst

This is Nathan on for Chris. Following the recent Pacira deal, just curious on how you're thinking about capital deployment and BD priorities from here? And then the second question would be, I think you noted that you secured first to file status for Wegovy in the call. Just curious how you're thinking about maybe the magnitude of capacity that you can get there?

Scott Smith

Thanks for the question. I think from a capital allocation perspective, we don't see any changes in our capital allocation priorities. We're going to continue to pay dividend, buy back shares and continue to do business development over the next 3 to 5 years. We bought back shares already this year. We may even do some more this year as we go forward. We'll be opportunistic in how we do that. But we don't see any changes in our capital allocation strategy at all. In terms of BD, we'll continue to be. We're continuing to look for things that are accretive in market. We can be good owners of that are going to add to our growth profile going forward.

So we're going to do all those things, and we're going to have sufficient cash to be able to do that. over the next 3, 5 years, between now and 2030, buy back shares, pay the dividend and do BD that makes sense for us.

And then we go tablet 25 mg yes, we said that we secured the first 5. Again, that's for the tablet. We -- but as you know, we've had a significant offering for GLP-1s in the future where we basically developed every presentation for Semaglutide, but also for [indiscernible] focus, as we've said in the past, will be primarily in the U.S. where we can significantly differentiate and use our technology to further differentiate versus competition. That said, we will also be selectively launching in other regions for the GLP-1. So we are very well placed. We have many first to files on all these presentations and are getting ready for the U.S. market.

Operator

And our next question comes from Daniel Clark from Leerink. .

Daniel Christopher Clark

Just wanted to drill down on the HRT kind of market and how you're thinking about growth opportunities here. I appreciate the color that less than 30% of women with menopausal symptoms are being treated with HRT where do you think that can kind of go given this is an unprecedented situation. I think [indiscernible] to figure out where real demand is here at this point. .

Scott Smith

Thanks for the question, Dan. Gear over to Corinne for response.

Corinne Le Goff

Yes, thank you for your questions. So, I think that -- as I said, it's a very large and market. There is now much more ease in prescribing overall replacement therapies coming from clinicians. And women now being made aware that they can now have access to -- also other formulations of Estradiol and progesterone for relieving their menopausal symptoms. So potentially, this market is large. Can we say exactly why it's going to go. I can only say that foreseeable fitter is going to go. Just to give you some data on our products, our patches, we expect that they are going to reach 1.5 million women this year in '26 and we're going to add in '27 another 1 million of women using our patches.

So we are very encouraged by this. I think it's wonderful to see that this market is opening up again, right, because it's been about 10 years without the possibility of treating women with menopausal symptoms. And we are going back to levels of prescriptions that we experienced back in 2002, it's 20 years -- 2002.

Operator

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

Scott Smith

As we approach the end of 2026, I'm very encouraged by the continued progress we're making in executing our strategy and advancing toward our long-term financial targets and the momentum we are building for the years ahead. With a strong and evolving base business, important innovative medicines opportunities ahead of us and the planned acquisition of Pacira, I believe we're well positioned for long-term sustained growth. We've already accomplished a lot this year, and I'm excited about what's ahead in '27 and beyond for Viatris. Thank you all for your attention.

Operator

The conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.