Amgen Inc.

My name is Erica and I will be your conference facilitator today for Amgen's first quarter 2021 financial results 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, press the pound key. I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Erica, thank you. Good afternoon, everybody. Welcome to our Q1 call. I think the two key themes for this quarter are continued focus on volume-driven growth and pipeline advancement. Lots to cover, but we'll do our best to stick to an efficient format of limited prepared comments and addressing your one best question. The slides have been posted. Just a quick reminder that we'll use non-GAAP financial measures in our presentation, and some of the statements will be forward-looking statements. Our SEC filings identify factors that could cause our actual results to differ materially. So with that, I would like to turn the call over to our Chairman and CEO, Bob Bradway. Bob?

Okay. Thank you, Arvind. And hello, everyone, and thank you for joining our call. We've had a busy start to 2021 and a first quarter that's something of a mirror image to what we experienced a year ago. Last year, if you recall, we came out of the gate with a very strong January and February and then started to really feel the impact of the pandemic in March. This year, especially in the U.S., it was almost the reverse. We felt the impact of the pandemic in January and February, and we began to see a recovery in March, a trend that seems to be holding in April as well. Setting aside the pandemic, we executed effectively in the first quarter, and this is reflected in the strong competitive performance of our brands globally, our strong biosimilar showing, the rapid progress of our lead pipeline molecules, and the addition of an attractive phase three ready molecule in oncology. Altogether, we remain confident in our full-year outlook. We're fortunate to have a diverse portfolio of newer products that continue to show strong volume growth. Repatha, for example, delivered 36% volume growth in the first quarter. It remains the clear leader of the PCSK9 market globally and will soon reach the milestone of 1 million patients served. We're also the global leader in bone health, with Prolia and Avenity generating double-digit volume in the quarter. Our industry-leading portfolio of biosimilars is annualizing above the $2 billion mark, and I would remind you that we have three additional biosimilars in Phase III development and look forward to a flow of new launch opportunities for these and Amgivita over the next few years. As we've shared with you many times in the past, we're active in business development, looking to complement our internally developed innovation with compelling external opportunities, and our recent acquisition of Five Prime Therapeutics is a good example of that. As you know, one of the molecules we acquired in that deal, Femiratuzumab, was granted breakthrough therapy designation by the FDA as a first-line therapy for a subset of patients with gastric cancer. More than one million new gastric cancer cases are diagnosed annually, and the disease is particularly prevalent in the Asia-Pacific region, which we've said previously will account for approximately 25 percent of our growth over the next decade. Pemrituzumab is now our third late-stage clinical medicine to be granted breakthrough therapy status, joining Sotiracib, for which the trade name Lumicress has now been provisionally approved for use in the U.S., and Tezapelumab also has earned that breakthrough therapy distinction. With a strong balance sheet, healthy cash flows, and a proven ability to integrate, we'll continue to look for external opportunities that strengthen us in our stated areas of focus. Before I turn things over to our CFO, Peter Griffith, I want to thank my Amgen colleagues for their continued commitment to serving patients around the world and delivering results for our stakeholders. I look forward to our Q&A session a little later in our call.