Viatris Inc.

Good day everyone and welcome to the Beatrice Second Quarter 2025 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please stay in 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 and then 1 on your touchtone phones. To withdraw your questions, you may press star and 2. Please also note today's event is being recorded. At this time, I would like to turn the floor over to Bill Cebulski, head of investor relations. Sir, please go ahead.

Good morning everyone. Welcome to our Q2 2025 earnings call. With us today is our CEO Scott Smith, CFO Doretta Mistress, Chief R&D Officer Fleet Martin and Chief Commercial Officer Corinne Legoff. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2025 and various strategic initiatives. These statements are subject to risk and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to the most directly comparable GAAP measures. 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 or reported results to our expectations, we are making comparisons to our 2025 financial guidance. With that, I'll hand the call over to our CEO Scott Smith.

Good morning, everyone. We delivered strong second quarter performance and stayed sharply focused on our key 2025 strategic priorities, which are driving strong commercial execution across our global business of generics and established brands, advancing our late stage pipeline to drive future innovation, continuing to look at strategic, accretive in-market business development opportunities to drive near and midterm growth, progressing our enterprise-wide strategic review to position VH risk for sustainable growth in 2016 and beyond, and returning capital to shareholders through dividends and share buybacks. Let me begin with a few highlights from our second quarter performance. We achieved 3% divestiture adjusted operational revenue growth, excluding the impact from indoor, driven primarily by strength in Europe and the Greater China region. These results reflect the strength of our execution and the resilience of our diversified global business. We have also made significant pipeline progress. Five of our six anticipated phase three readouts have shown positive results. Most recently, this includes positive data from two ophthalmology programs targeting dim light disturbances and presbyopia, both of which address high unmet medical needs. With these readouts and our commercial assets, our eye care division remains well positioned to become a more meaningful contributor to VH risk over the next few years. Earlier this year, we shared positive results for effects for generalized anxiety disorder in Japan, Zulane low dose for contraception, and our fast-acting formulation of meloxicam and acute pain. These achievements reinforce the strength of our pipeline and lay the foundation for our future. A particular note, the two phase three studies for our meloxicam candidate demonstrated meaningful improvement in pain and reduced opioid use relative to placebo. A well-characterized and well-tolerated safety profile and superior pain control versus an opioid arm in post-hoc analyses. We expect to file by year end and intend to commercialize this as a branded product, tapping into an $80 billion US acute pain market. For Celada Grille and Senerimod, enrollment for the phase three global programs for both assets is progressing well with first data readouts expected in 2026. We continue to view both of these as potentially transformational blockbuster treatments for patients in their respective therapeutic areas. For Sotagliflozin, we received our first approval in the UAE earlier this year and filings are progressing well in other key countries around the world. As our pipeline advances, we remain committed to returning meaningful capital to shareholders. So far this year, we have returned more than $630 million, including $350 million in share repurchases. We continue to balance our focus on shareholder returns with strategic, accretive, in-market business development investments that could fuel future growth. We are also making strong progress on our enterprise-wide strategic review, evaluating all aspects of our business to ensure we're building a company that is both competitive today and prepared for the future. We plan to share an update of our progress during our Q3 earnings call in November. Turning to operational priorities, we remain focused on remediation efforts at our indoor facility, which are now nearly complete. Before the end of this month, we'll be asking the FDA for a meeting to discuss the progress of our remediation efforts and the potential timing for re-inspection of the facility. At our Nashuk facility, while FDA classification is still pending, all committed actions have been completed for some time. Encouragingly, we recently received FDA approval for Derunavir tablets and antiretroviral medicine made at our Nashuk facility. Finally, I'd like to touch on recent policy developments, including proposed U.S. tariffs, which could impact the broader pharmaceutical landscape. Vietrst serves approximately 1 billion patients worldwide each year. Our global supply chain is built to support patients where they live. Of the 37 manufacturing, distribution, R&D and packaging sites within our global network, eight are located in the United States, which should position as well to navigate the impact of any future changes to trade policy. While we're monitoring tariff developments closely in order to assess potential impact on our business, based on the available information, we do not anticipate any material effect on our 2025 financial picture. We will continue to assess the impact of any potential tariffs on patient access and company financials and will provide updates accordingly. We also continue to advocate strongly for thoughtful policymaking that protects access to medications, especially generics, which account for 90% prescriptions filled in the United States and just 1% of the total healthcare spend. Currently, more than half of our U.S. revenue is sourced domestically, and we are currently exploring ways to further leverage and expand our network. With that said, based on the current pricing dynamics in the generics industry, we believe that moving additional manufacturing of non-complex generics to the United States would be very difficult in the short term and not likely sustainable in the long term. However, our move towards more complex, innovative, higher margin products does bring potential opportunity to further expand our domestic footprint. We are committed to evaluating all possible options. Ultimately, our goal is to ensure the right infrastructure is in place to serve patients in the United States and around the globe and maintain a sustainable business model. In closing, we have great momentum going into the second half of the year. Given the strength of the results, we are reiterating our 2025 financial guidance ranges across all key metrics and currently expect to be in the top half of the range on revenue and adjusted EPS. We remain confident in the long-term trajectory of the interest. The strength of our business, our maturing late-stage pipeline, disciplined capital allocation, and strategic flexibility position us well for sustainable growth in 2016 and beyond. Now I'd like to turn it over to Philippe for more details on the pipeline.