Viatris Inc.

Good morning and welcome to the Vietris Q3 2025 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Bill Cebulski, Head of Capital Markets. Please go ahead.

Good morning, everyone. Welcome to our Q3 2025 Earnings Call. With us today is our CEO, Scott Smith, CFO, Doretta Mistress, Chief R&D Officer, Philippe Martin, and Chief Commercial Officer, Karine L'Golf. 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. 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 2025 actual or reported results, we will be making certain comparisons to 2024 actual or reported results on a divestiture-adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 from the 2024 period. We may refer to those as changes on an operational basis when comparing our 2025 actual reported results to our expectations We're making comparisons to our 2025 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Good morning, everyone. We delivered another strong quarter by focusing on our 2025 strategic priorities. Driving strong commercial execution, advancing our pipeline, returning capital to shareholders through dividends and share repurchases, pursuing in-market business development opportunities, and advancing our enterprise-wide strategic review to identify opportunities to deliver meaningful net cost savings, a portion of which we anticipate reinvesting in the business to fund future growth. Our fundamentals remain solid, giving us good momentum as we head into year-end, momentum we expect to carry into 2026. Before we dive into the details of the quarter, let me provide an update on our strategic review. For context, The work we've done over the past five years, strengthening our balance sheet, divesting non-core assets, and investing in innovation, has set the stage for the strategic review as a natural next step in our evolution. We've made significant progress since we announced the initiative in February. We continue to perform a detailed analysis of the totality of our business. As part of our analysis to date, we've identified areas for potential operating efficiencies, including... our commercial sales and marketing model and product mix, our R&D medical and regulatory activities, our sourcing, manufacturing, and supply chain, including inventory optimization, and how our corporate functions provide support. Looking to the future, we envision a company that delivers sustained profitable growth by focusing on three key areas. A global generics business that will continue to evolve towards more profitable, higher margin complex products, an established brands business that will be strengthened by continuing to add brands that leverage our global capabilities, and an innovative brands business that will be expanded by building a portfolio of late-stage or in-market growth assets sourced both internally and externally. We anticipate being able to deliver meaningful net cost savings over a multi-year period, while also being able to reinvest a portion of the savings back into the business to fund future growth opportunities. We look forward to sharing more details, including quantification of the net cost savings and reinvestment opportunities at our planned investor event in the first quarter of 2026. Now let me share a few highlights from the quarter. This quarter's commercial performance was strong across our portfolio, particularly in Europe, emerging markets, and the greater China region. We delivered 1% operational revenue growth, excluding indoor, in line with our expectations, reflecting continued execution across our businesses. Primarily driven by the benefit from foreign exchange and supported by our strong operational performance, we are raising our full-year guidance range across certain key financial metrics, including total revenues, adjusted EBITDA, and adjusted EPS. At our indoor facility, our initial remediation activities are substantially complete. We recently met with the FDA to review progress and discuss potential timing for re-inspection. While timing remained to the discretion of the agency, we have built and continue to build operational redundancies by requalifying other sites and adding third-party vendors for products originally manufactured at indoor. Importantly, we continue to make progress on advancing our pipeline. Here are some of the highlights. We are excited about our fast-acting MLOX scan. The acute pain market in the U.S. is significant, and we believe we can offer a differentiated alternative for patients seeking non-opioid pain relief. We expect to submit our NDA by the end of the year and are already working on our go-to-market strategy. Our low-dose estrogen weekly patch is now under FDA review following the filing of our NDA late in Q3 with a decision expected in mid-2026 and a launch soon thereafter. For Sotico-Flosa, we've already made filings in multiple markets around the world and expect to file in more countries by the end of the year. For Saladagrel and Saneramod, Phase III enrollment for both programs is progressing well. In addition, we've initiated a Phase III program investigating Saneramod for the treatment of lupus nephritis with enrollment of our first patient anticipated by the end of the year. We continue to view both Saladagrel and Saneramod as transformational treatments, with blockbuster potential, and are beginning to plan for commercialization. We are excited about our recent acquisition of Oculus Farm in Japan, adding two innovative CNS assets, Patolasan and Spideator, to our portfolio. This strengthens our presence in Japan, a strategically important market for us, and leverages our CNS infrastructure and expertise. Business development and M&A remain key strategic levers to accelerate growth, enhance shareholder value, and create meaningful impact for patients. Through regional business development, we continue to pursue opportunities that strengthen our generics and established brands portfolios while building our presence in innovative brands that can benefit from our global scale, capabilities, and infrastructure. In parallel, we are evaluating targeted strategic M&A opportunities, particularly in the U.S., focused on commercial stage accretive transactions designed to expand our business to further enhance the company's long-term growth profile. We're balancing investment and growth with return of capital to shareholders through dividends and share repurchases. Year-to-date, we've returned more than $920 million to shareholders, including $500 million in share repurchases. This puts us firmly on track to return over $1 billion in capital for the year. Overall, we're very encouraged by the progress we're making taking bold actions that are intended to strengthen our foundation, expand our capabilities, and position Beatrice for long-term profitable growth. We believe we're building a company that's more agile, more innovative, and better aligned with the opportunities for tomorrow. Now we'll turn it over to Philippe.