Amgen Inc.

My name is Julianne and I will be your conference facilitator today for the Amgen Q1 FY 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. There will be a question and answer session at the conclusion of the last speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. To ask a question, please press star then the number one on your telephone keypad. To withdraw your question, please press star 1 again. I would now like to introduce Justin Clays, Vice President of Investor Relations. Mr. Clays, you may now begin.

Good afternoon, and welcome to our first quarter 2025 earnings call. Bob Bradley will lead the call and be followed by a broader review of our performance by Myrtle Gordon, Jay Bradner, and Peter Griffith. Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance, and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward-looking statements, which are qualified by our Safe Harbor Statement, and please note that actual results can vary materially. Over to you, Bob.

Okay, good afternoon, everyone, and thank you for joining us today. We're off to a strong start in 2025, and this was an exciting quarter, one with strong volume growth across the enterprise, important new product launches, and positive Phase III data. Revenue grew 9% year-over-year. Volume grew 14%, reflecting growing patient demand for our innovative medicines. Fourteen of our medicines delivered double-digit sales growth, spanning general medicine, rare disease, inflammation, and oncology. Our industry-leading biosimilars portfolio added to this performance, delivering more than $700 million in revenue this quarter, which was up 35% year-over-year. Beyond the strong financials, this quarter demonstrated the breadth and depth of our portfolio and the strength of our execution. We delivered multiple positive Phase III readouts, initiated four new Phase III studies, and launched three new products or indications. With that, let me turn to some of the key drivers of our momentum. Starting in general medicine, we're addressing large, underserved patient populations with multiple products which have significant room for growth. Heart disease remains the leading cause of death globally. Repatha, now a multibillion-dollar product, continues to grow as access improves for patients. we're also advancing the El Pazaran Clinical Program, which addresses an important residual risk factor in heart disease. It's currently being evaluated in a large Phase III cardiovascular outcomes trial. In bone health, Amgen is the global leader, and we expect continued long-term growth in this area. Avenity, which is the only bone builder which also slows bone loss, reduces fracture risk for millions of postmenopausal women. We're rapidly advancing Maritide, having initiated the first chronic weight management phase three studies of our broad clinical program in obesity and obesity-related conditions. Turning to rare disease, our four key growth drivers, Tepesa, Cristexa, Uplizna, and Tavneos, are all early in their life cycles and well-positioned for long-term growth. Uplizna is a differentiated B-cell depleting therapy. It's the leading biologic for the treatment of NMOSD and recently launched as the first and only FDA-approved treatment for IgG4-related disease, which is a serious and underserved autoimmune condition. We're encouraged by the positive reception from patients and physicians in the early stage of the launch. We've also filed Phase III data for Oplizna and generalized myasthenia gravis, with the FDA and we're exploring its potential across additional B-cell mediated diseases. In inflammation, we remain focused on difficult to treat diseases where the need for innovation is the highest. Tezspire is a first in class therapy that targets TSLP, a differentiated mechanism with broad potential across a number of diseases. In severe asthma, It continues to build strong momentum with high prescriber confidence. We've also delivered compelling Phase III data in rhinosinusitis with nasal polyps, and most recently, initiated two pivotal Phase III studies in COPD, the world's third leading cause of death. In oncology, our leading bispecific T-cell engager platform continues to develop new standards of care. Blinsido has moved into frontline treatment and continues to grow. The FDA has granted breakthrough therapy designation for Blinitumumab for subcutaneous treatment of BALL, which Jay will speak to shortly. Imdeltra provided an overwhelming survival benefit at an interim analysis in a Phase III study in second-line small-cell lung cancer, beating chemotherapy as a standard of care. These data represent a meaningful milestone for patients and will be presented at ASCO in June. Valuridamig is enrolling well in our Phase III study in advanced prostate cancer patients. Next, our industry-leading biosimilars portfolio continues to contribute meaningfully to our long-term growth. We have a proven approach in this area. Be in the first wave of launches and ensure a safe and reliable supply. We're seeing that formula deliver again this quarter with our next wave of U.S. launches underway, including PavBlue, Weslana, and Bekemvi. I recognize there's a lot of uncertainty at the moment related to tariffs and taxes. Given the long life cycle of our business, clarity on these issues is important to us, and I'm sure it's important to all of you as well. While it's premature to speculate what the outcomes of tariff and taxes might be for our business, I would remind you that we've proven our ability to adapt and we've demonstrated the operating agility necessary to navigate change and deliver long-term growth. With respect to manufacturing, I want to point out that following the 2017 tax reform, we invested nearly $5 billion in U.S. capital projects as measured through 2024 and And in addition, we've recently announced nearly $2 billion in additional expansions in the states of Ohio and North Carolina. We're actively engaged on policy matters, and we remain focused on meeting the growing demand for our medicines. And to the extent that changes in taxes or tariffs require us to adapt, we'll do so accordingly. Let's go back to where I started. This was an exciting quarter, not just because of the financial results, but because of what those results signal about our future. Inline brands are delivering. We're advancing positive phase three studies. We're launching new products. We're earning breakthrough designations, and we're initiating the next wave of late-stage programs. We're operating in a volatile environment, but what hasn't changed is the growing patient demand for our medicines and the unwavering focus of our people. Amgen is well positioned to deliver innovation and growth, not just this year, but for the long term. I want to thank our nearly 28,000 colleagues around the world for their dedication to our mission, serving patients. With that, I'll turn over to Murdo for a commercial update.