Merck & Co., Inc.

Thank you for standing by. Welcome to the Merkin Company, Inc., Raleigh, New Jersey, USA, fourth quarter sales and earnings conference call. At this time, all participants are in a listen-only mode until the question and answer session of today's conference. At that time, if you'd like to ask a question, you may press star 1 on your phone and record your name at the prompt. This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the conference over to Mr. Peter Danbaum. Senior Vice President, Investor Relations. Sir, you may begin.

Thank you, Shirley, and good morning, everyone. Welcome to the fourth quarter 2025 conference call from Merck and Company Incorporated, Raleway, New Jersey, USA. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee, President of Research Labs. Before we get started, I'd like to point out that we have items in our GAAP results, such as acquisition-related charges, restructuring costs, and certain other items that we have excluded from our non-GAAP results. There is a reconciliation in our press release. I will also remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of our company's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A and the 2024 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck and Company Incorporated, Rodway, New Jersey, USA, undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release, today's prepared remarks, and our SEC filings are all posted to the investor relations section of our company's website. With that, I'd like to turn the call to Rob.

Thanks, Peter. Good morning, and thank you for joining today's call. Our company's purpose to save and improve lives guides everything we do. In 2025, we advanced key programs across all phases of development, furthering our mission to deliver transformative medicines and vaccines that will improve health outcomes for patients around the world. I'm very proud of the significant progress we are making. As we look ahead, we'll remain intently focused on bringing forward breakthrough science and innovation, which is the foundation for creating sustainable long-term value for both patients and shareholders. The transformation of our portfolio is well underway, and momentum is building as we continue to execute on our strategy. In 2025, our business benefited from successful new product launches, the advancement of important clinical programs, and the expansion of our respiratory and infectious disease portfolios through the acquisitions of Verona Pharma and Sedera Therapeutics. As a result of this progress, we now have line of sight to over $70 billion of potential commercial opportunity by the mid-2030s, $20 billion more than just a year ago, and more than double consensus 2028 peak Cotruda revenue of $35 billion. While we still have more to do, this meaningful progress further bolsters my already high confidence in our ability to deliver sustainable growth post the Cotruda LOE period. Now, turning to our results and initial outlook for 2026. Growth in 2025 reflects demand for our innovative portfolio, including for Keytruda, which continues to benefit more patients with cancer globally, increasing contributions from new launches in cardiometabolic and respiratory, as well as vaccines, and strong performance of animal health. We're well positioned to achieve commercial success across key products in 2026 while we make important investments behind our new product launches and expanded pipeline, which Caroline will speak to momentarily. Our research colleagues continue to achieve remarkable progress across our broad and deep pipeline. Focusing on a few key events from the fourth quarter in cardiometabolic and respiratory, at AHA, we presented phase three results for Inlicitide that underscore the practice-changing potential of an oral PCSK9 inhibitor. Cardiovascular disease is the leading cause of death globally, and we look forward to bringing a potential new option to help address the CV epidemic. For Winrevere, we announced Phase II top-line findings from the CAGENS trial that are supportive of its continued development in a different type of pulmonary hypertension. And building on recent momentum in HIV, we shared positive top-line results for azotrevir in combination with the Ravarin for treatment-naive adults living with HIV. Finally, we're pleased that both Inlicitide and SAC-TMT, our investigational TROP2-directed antibody drug conjugate, were granted Commissioner's National Priority Vouchers by the FDA, which may expedite review of these important investigational candidates after applications are filed. We recently completed the acquisition of Sedera, which complements our portfolio and builds on our long legacy in combating infectious diseases. MK1406, formerly CD388, is a potentially first-in-class, long-acting antiviral candidate designed to help prevent influenza infection in individuals at higher risk of developing serious complications. There is a substantial unmet need for influenza prevention in a large at-risk population, and Phase II results were very promising. We believe MK1406 has greater than $5 billion in revenue potential and can be a meaningful driver of growth later this decade and through the next. We're excited to welcome the Sidera team to our company and look forward to advancing this novel preventative antiviral agent. Today, our business is anchored by an important set of commercial products that address critical unmet needs. We're also executing on the transformation of our portfolio with initial launches from over 20 potential new growth drivers that have the promise to advance the practice of medicine and change patient lives. Ten of these programs could be substantially clinically de-risked over the next two years and represent the majority of our $70 billion of non-risk-adjusted commercial opportunity by the mid-2030s. And our long-term outlook is further bolstered by the strong growth we expect in our animal health business, by the many early phase programs that will enter phase two in the near term, and through additional potential science-led, disciplined, and value-enhancing business development. We're entering a particularly robust period of first-time phase three data readouts for novel candidates. In 2026, these include izlatravir combined with linacapravir, potentially the first once-weekly oral treatment regimen for people living with HIV. MK3000, potentially the first new mechanism of action in two decades for patients with certain retinal diseases. And Tulisa Keybark, where we expect to see phase three results in ulcerative colitis, as well as phase two data in other autoimmune diseases. There is an even richer array of expected readouts in 2027, including phase three results for Sac TMT, which we believe is a differentiated trope two ADC. For IDXT, our B7H3 antibody drug conjugate being studied in small cell lung cancer and other tumor types. For MK1406, as well as for a number of other important programs. In summary, we're successfully executing multiple product launches, making significant clinical advancements, and augmenting our pipeline with strategic business development. We're also making the necessary investments that will sustain our success over the long term. Our progress and momentum positions us to continue delivering on our purpose for patients and create durable value for shareholders. I want to recognize and thank our global teams for their commitment. While there is more to do, the actions taken, the progress we've made, and our continued disciplined execution provide me with strong confidence that we're well positioned for our next chapter of success. With that, I'll turn the call over to Caroline.