Organon & Co.

question during this time, please press star 1 on your telephone keypad. I would now like to turn the conference over to Jennifer Halchuk, Vice President Investor Relations. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining Organon's second quarter earnings call. With me today are Kevin Ali, Organon's Chief Executive Officer, and Matt Walsh, our Chief Financial Officer. Juan Camilo Arjona-Ferreira, Organon's Head of R&D, will also be joining for the Q&A portion of this call. Today we will be referencing a presentation that will be visible during this call for those of you on our webcast. This presentation will also be available following this call on the events and presentation section of our Organon Investor Relations website at .organon.com. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements. Actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the Securities and Exchange Commission, including their 10K and subsequent periodic filings. In addition, we will discuss certain non-GAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAP. A reconciliation of these non-GAP measures to the comparable GAP measures is included in the press release and conference call presentation. I would now like to turn the call over to our CEO, Kevin Ali.

Good morning, everyone, and thank you, Jen. Revenue for the second quarter was $1.6 billion, down 1% at constant currency, with our growth pillars and contributions from new assets and new companies. This is mostly offsetting the loss of exclusivity of AdoZed in the EU. Given -to-date operational performance and our current view of movements in various foreign currencies, we are raising our revenue guidance range by $100 million at the midpoint. Additionally, we generated strong adjusted EBITDA this quarter of $522 million, representing a .7% margin. -to-date, our adjusted EBITDA is $1 billion, or a .4% margin. Strength -to-date was primarily due to favorability in adjusted gross margin, investment prioritization behind our growth pillars, and the realization of savings from our restructuring programs to become a more -for-purpose organization. As a result, we are affirming our adjusted EBITDA margin guidance range of 31 to 32%. A strong focus on EBITDA generation underpins our objectives to deliver more than $900 million of pre-cash flow before one-time costs in 2025. -to-date, we're tracking well against that goal. As we signaled to you last quarter, we are committed to reducing our debt burden. To that end, in the second quarter, we repaid approximately $350 million of principal on long-term debt instruments, which sets us up on a path to achieving net leverage below four times by year-end. Midterm, we'll aim to drive further improvements in net leverage with the goal of achieving net leverage of 3.5 times or below by the end of 2026. Let's now talk about franchise performance, beginning with women's health. The women's health franchise grew 2% at constant currency in the second quarter of 2025 compared with the second quarter of 2024. The company's fertility business grew 15% at constant currency in the second quarter. This was driven by a favorable -over-year comparison in fall of 2020 related to the late 2023 exit of a spin-related interim operating model with Merck and increased demand. We expect continuous growth in the U.S. along with geographical expansion to deliver high single-digit growth in our global fertility business in 2025. Within women's health, Jada also grew double-digit in the quarter and -to-date. Among hospitals that have the highest adoption rates, Jada is used in nearly half of all postpartum hemorrhage readiness and response protocols in the U.S. hospitals. Sales of Nexplanon declined 1% at constant currency in the second quarter. Revenue declined by 5% in the U.S. While outside the U.S., Nexplanon grew 10% at constant currency. For the first six months of the year, Nexplanon has grown 6% globally at constant currency. In the U.S., customers relying on federal and state-subsidized programs are now facing potentially constrained funding. That is factoring into their purchasing decisions for contraceptive products. Despite these headwinds, we anticipate continued global growth for Nexplanon, building on its strong double-digit expansion achieved in 2024. Current policy issues notwithstanding, we remain committed to building Nexplanon into a billion-dollar franchise in the very near future, reflecting our confidence in its long-term growth potential. For Nexplanon's five-year duration indication, we have made our submission to the FDA, putting us in a position to be ready for launch later this year. As we have reiterated each quarter, we believe this indication is attractive to a much broader addressable market, and we believe Nexplanon can continue to grow until the end of the decade. Turning the discussion to general medicines, which is our refreshed term for our business outside of women's health, we believe it is a better characterization of the innovation we are introducing with products like Mgality and Vitama. We will continue to discuss our biosimilars products separately, given their collective importance as a growth driver for the company. So then, let's start with biosimilars, which is performing better than our expectations. -to-date, performance is largely driven by Head Lima, which has generated almost $100 million as of June, up 68% compared with the prior year period. In the U.S., Head Lima continues to rank among the leading biosimilars in terms of total prescriptions. This performance reflects the strong clinical profile of Head Lima, which includes the recent interchangeability approval. Head Lima has also benefited from the effectiveness of our commercial strategy and our market access teams, which have expanded availability to a broader patient population. We've also added Tofenance, the first biosimilar approved for Actemra, to the portfolio in the U.S. Immunology is a market we know well in the U.S., notably the physician-administered business, and as a result, we are uniquely positioned to drive topating sales. Finally, we will begin to launch a portfolio of Henleus products in late 2025 with a Denosimab biosimilar in the U.S. So it's better performance in the base business, together with our outlook for new assets coming online, that have improved our view of performance in the biosimilar business for the full year. Wrapping up the discussion with established brands with a focus on Vitama. Vitama had strong performance in the second quarter with revenue of $31 million, up 35% sequentially, and up 70% versus a year ago when it was still under Dermavan. In the second quarter, NRX and TRX each grew mid-teens over Q1, representing the strongest quarterly performance among the peer sets. Since launch, we have added over 20,000 new Vitama prescribers. When Organon acquired Dermavant, Vitama was accessible to about a third of the addressable population, and broader assets had significant barriers. We have achieved meaningful improvements in our access objectives to date, and are on track to achieve 80% of the addressable population covered in both national and regional health care plans by early 2026. We've only just begun to unlock the potential of this asset. Vitama is approved for patients as young as two years of age. This unlocks a pediatric segment, where treatment options are limited and safety concerns with existing therapies are significant. Other competitors in this space have labels approved for six years of age and up, so this is a subset of pediatrics where we have a significant advantage. As we reflect on the first half of 2025, we're proud of several key accomplishments that have set a strong foundation for the remainder of the year. Our portfolio is performing well, overcoming and mitigating the negative effects of the LOE and the EU of our second largest product, Adizette. We have created efficiencies in our expense base, which are reflected in our -to-date results and in our adjusted EBITDA margin guidance. We took action on our capital allocation priorities in order to accelerate the reduction of our net leverage paying down principle on long-term debt, and we have a clear pathway to achieving a net leverage ratio below four times by the end of this year. And finally, we acquired a new growth catalyst in Vitama. -to-date, we're right where we want it to be with Vitama, making significant progress on our access objectives, which gives us confidence in our ability to deliver on our 2025 Vitama revenue objectives. I'll now turn the call over to Matt, who will review the financials in more detail.