Scott Andrew Smith
Analyst · Goldman Sachs
Good morning, everyone. We delivered strong second quarter performance and stayed sharply focused on our key 2025 strategic priorities, which are driving strong commercial execution across our global business of generics and established brands, advancing our late-stage pipeline to drive future innovation, continuing to look at strategic accretive in-market business development opportunities to drive near and midterm growth, progressing our enterprise-wide strategic review to position Viatris for sustainable growth in '26 and beyond and returning capital to shareholders through dividends and share buybacks. Let me begin with a few highlights from our second quarter performance. We achieved 3% divestiture-adjusted operational revenue growth, excluding the impact from Indore, driven primarily by strength in Europe and the Greater China region. These results reflect the strength of our execution and the resilience of our diversified global business. We have also made significant pipeline progress. 5 of our 6 anticipated Phase III readouts have shown positive results. Most recently, this includes positive data from 2 ophthalmology programs targeting dim-like disturbances and presbyopia, both of which address high unmet medical needs. With these readouts and our commercial assets, our Eye Care division remains well positioned to become a more meaningful contributor to Viatris over the next few years. Earlier this year, we shared positive results for EFFEXOR for generalized anxiety disorder in Japan, XULANE low dose for contraception and our fast-acting formulation of meloxicam in acute pain. These achievements reinforce the strength of our pipeline and lay the foundation for our future. Of particular note, the 2 Phase III studies for our meloxicam candidate demonstrated meaningful improvement in pain and reduced opioid use relative to placebo, a well-characterized and well-tolerated safety profile and superior pain control versus an opioid arm in post-hoc analyses. We expect to file by year-end and intend to commercialize this as a branded product tapping into an $80 billion U.S. acute pain market. For selatogrel and cenerimod, enrollment for the Phase III global programs for both assets is progressing well with first data readouts expected in 2026. We continue to view both of these as potentially transformational blockbuster treatments for patients in their respective therapeutic areas. 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 Indore facility, which are now nearly complete. Before the end of this month, we'll be asking the FDA for a meeting to discuss the progress of our remediation efforts and the potential timing for reinspection of the facility. At our Nashik facility, while FDA classification is still pending, all committed actions have been completed for some time. Encouragingly, we recently received FDA approval for darunavir tablets an antiretroviral medicine made at our Nashik facility. Finally, I'd like to touch on recent policy developments, including proposed U.S. tariffs, which could impact the broader pharmaceutical landscape. Viatris serves approximately 1 billion patients worldwide each year. Our global supply chain is built to support patients where they live. Of the 37 manufacturing, distribution, R&D and packaging sites within our global network, 8 are located in the United States, which should position us well to navigate the impact of any future changes to trade policy. While we're monitoring tariff developments closely in order to assess potential impact on our business, based on the available information, we do not anticipate any material effect on our 2025 financial picture. We will continue to assess the impact of any potential tariffs on patient access and company financials, and we will provide updates accordingly. We also continue to advocate strongly for thoughtful policymaking that protects access to medications, especially generics, which account for 90% of prescriptions filled in the United States and just 1% of the total health care spend. Currently, more than half of our 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 noncomplex generics in the United States would be very difficult in the short term and not likely sustainable in the long term. However, our move towards more complex, innovative, higher-margin products does bring potential opportunity to further expand our domestic footprint. 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 Viatris. The strength of our business, our maturing late-stage pipeline, disciplined capital allocation and strategic flexibility position us well for sustainable growth in '26 and beyond. Now I'd like to turn it over to Philippe for more details on the pipeline.