Amgen Inc.

My name is Erica and I will be your conference facilitator today for Engin's fourth quarter 2020 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 1 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.

Okay. Thank you, Erica. Good afternoon, everybody. Welcome to our call to review our Q4 and full-year financial results for 2020. I would say the strong execution despite the pandemic and pipeline advancement are two themes that were pervasive, so let's get after it. We'll stick to an efficient format of limited prepared comments or one-question rule, as Erica pointed out, and the overall duration of the call to one hour. Slides have been posted. Just a quick reminder that we use non-GAAP financial measures in our presentation, and some of the statements will be forward-looking. Are SEC filings identified 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?

Thank you, Irvin, and thank all of you for joining our call. I'll start today by discussing Amgen's performance in 2020 and then provide some perspective on our priorities for 2021. By any measure, 2020 was a very successful year for us. Despite the disruption of COVID-19, we delivered strong sales and earnings, driven by volume growth of 15% for our products. We advanced our innovative pipeline, most notably Sotiracid and Kezapelumab, both of which have received breakthrough therapy designation from the FDA. We successfully integrated Otezla, strengthening our decades-long leadership in inflammation with a $2 billion-plus product that we believe has runway further global growth. We grew our sales outside the US to more than $6 billion, delivering on long term goals by expanding our presence in China and Japan with successful transactions in both markets. We did all this while staying focused on the health and safety of our 24,000 employees around the world. To all of them, I want to say thank you for a job well done. As we look to 2021, we're embracing three realities. First, COVID-19 is leading to some lasting changes in how we do business. For example, we expect to continue leveraging digital capabilities to call on customers and run clinical trials around the world with improved speed, efficiency, effectiveness. Second, we expect ongoing pressure on drug prices across the industry. We are fortunate to have products like Repatha, Prolia, and Amavig that meet the needs of millions of patients and can grow through increased penetration of the appropriate patient populations. Our industry-leading portfolio of biosimilars is also well-positioned for the future. Third is capital continues to flow into our sector. We've entered a time of intense competition where speed of execution is paramount. We've built a track record. featuring quality and speed. We've shown that with innovative first-in-class medicines like Rapacin, the first approved PCSK9 inhibitor, and Amavig, the first approved CGRP inhibitor. We've shown it also with biosimilars like Invasi and Congenti, the first approved biosimilars to Avastin and Herceptin here in the U.S. And we're doing it right now with Sotiracid, the first KRAS G12C inhibitor to be filed for approval, just 28 months after we dosed our first patient. And we expect to do it again later in the year with tezopelumab as the first PSLP inhibitor. We're excited about our pipeline and plan on increasing our R&D investment in 2021. Dave will speak in a moment about some of our promising mid-stage pipeline candidates. But since this is the time of year when I like to address our long-term investments, I want to focus for a moment on a couple of areas central to our early research strategy. These are areas where we are building differentiated capabilities. First, in human genetics, where we have industry-leading capabilities, we are adding to our database approximately a million subjects from the U.S. and the U.K. for whom we will have extensive phenotypic and genotypic information. This will augment the data we already have on in excess of a million and a half individuals. In addition, we're pioneering the use of large-scale proteomics to measure the relative levels of some 5,000 different proteins in the blood. We're excited about the insights we're generating from this genomic proteomic work and expect to benefit in the selection of new drug targets and clinical trial design. There's growing interest in our industry in the area of targeted protein degradation. We believe the opportunity is broader than that, and our efforts are not just limited to degrading proteins. We're looking at degrading other biologic molecules as well. We're designing molecules to have multi-specific activity through a principle we call induced proximity. The idea is to use this platform to dramatically expand the universe of druggable targets. It's still early days in the field, but I wanted to flag it as an area where we want to emerge through time as an industry leader. All of our work is taking place at a time when more is expected of companies than ever before. Amgen is advancing an ambitious ESG agenda that includes providing medicines at no cost to low-income patients and funding world-class STEM education programs. With respect to the environment, we're committed to achieving carbon neutrality by 2027, along with a 40% reduction in water use and a 75% reduction in waste. In summary, our success in 2020 gives me great confidence in our ability to deliver in 2021 and beyond. The world needs more innovation, not less, and we've proven ourselves ready, willing, and able to provide it. I look forward to your questions a little later on in the call. Right now, let me turn over to Dave Reese, our head of R&D. Thanks, Bob, and good afternoon, everyone. I'll begin today with Sotiracid, a first-in-class KRAS G12C inhibitor. To date, more than 700 patients have been treated across five continents, and we are accelerating this groundbreaking program into new indications and earlier lines of therapy. A few days ago, we presented the first pivotal data for a KRAS T12C inhibitor at the World Conference on Lung Cancer, where we reported on 126 patients with second-line PLUS non-small-cell lung cancer. Sotiracib drove rapid, deep, and durable responses across a broad range of mutational profiles and subgroups with poor prognoses. In a centrally adjudicated intent-to-treat analysis, the objective response rate was 37%, including three complete remissions. Progression-free survival was 6.8 months, and duration of response was 10 months. Importantly, Sotiracic demonstrated a very tolerable and differentiated clinical profile, and based on these data, we completed regulatory submissions in the United States and EU in December. More recently, we submitted files in Canada, UK, Brazil, and Australia, with additional global submissions anticipated in the coming weeks and months, and launch preparations are well advanced. The Phase III non-small-cell lung cancer monotherapy study versus docetaxel continues to advance nicely, as do our 10 combination cohorts and Phase II colorectal study, with data expected from these latter two beginning in the first half of this year. We will initiate a phase two study in first-line non-small cell lung cancer in the second quarter, where we will investigate soteracid monotherapy in patients most likely to benefit based on tumor profile. For example, those tumors harboring STK11 mutations. Finally, we recently cleared the safety hurdle at the full soteracid dose in our MEK inhibitor combination study and have completed enrollment in an expansion cohort. In inflammation, along with our partner AstraZeneca, we look forward to presenting the results from the phase three navigator study at the American Academy of Allergy, Asthma, and Immunology virtual annual meeting, also known as Quad AI, at the end of February. You may have seen the abstract posting yesterday with results from the primary and key secondary endpoints, data that, in our view, provide a compelling rationale for the potential utility of tezopelumab in a broad population of patients with severe uncontrolled asthma, including those with low eosinophil counts where we have breakthrough therapy designation in the United States. We are working closely with AstraZeneca on our U.S. and EU filing packages, which we expect to submit in the first half. Turning to our bite platform, we're particularly excited about the rapid progress we are making with two solid tumor programs, AMG160 targeting prostate-specific membrane antigen, or PSMA, for castrate-resistant prostate cancer, and AMG757 targeting DLL3 for small cell lung cancer. AMG160 is currently in dose expansion, and we expect to advance AMG757 into dose expansion in the coming months. We are quite pleased with the clinical profiles we are seeing with both of these molecules. And, as you will see in our press release, we also continue to actively prioritize our oncology portfolio. In migraine, Amavig continues to demonstrate important benefits for patients as our colleagues at Novartis announced positive Phase IV results showing superior efficacy and safety of Amavig over to Pyramate in the migraine prevention setting. Finally, Our biosimilars portfolio continues to advance, and we have completed enrollment in our Phase III study of ABP959, our biosimilar Solaris. In closing, I'd like to thank our staff for their ongoing efforts to deliver our portfolio for patients. Murdo?