AbbVie Inc.

Good morning and thank you for standing by. Welcome to the AbbVie Fourth Quarter 2020 Earnings Conference Call. All participants will be able to listen only until the question and answer portion of this call. You may ask a question by pressing star 1 on your phone. I would now like to introduce Ms. Liz Shea, Vice President of Investor Relations.

Good morning and thanks for joining us. Also on the call with me today are Rick Gonzalez, Chairman of the Board and Chief Executive Officer, Michael Severino, Vice Chairman and President, and Rob Michael, Executive Vice President and Chief Financial Officer. Joining us for the Q&A portion of the call is Jeff Stewart, Executive Vice President, Commercial Operations. Before we get started, I remind you that some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. ABBYY cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on ABBYY's operations and financial results that may cause actual results to differ materially from those indicated in the forward-looking statements. Additional information about these risks and uncertainties is included in our 2019 annual report on Form 10-K and in our other SEC filings. ABBYY undertakes no obligation to update these forward-looking statements except as required by law. On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand AbbVie's ongoing business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Unless otherwise noted, our commentary on sales growth is on a comparable basis, which includes full current year and historical results for Allergan. For this comparison of underlying performance, all historically reported Allergan revenues have been recast to conform to Abby's revenue recognition accounting policies and exclude the divestitures of ZenPep and BioCase. References to operational growth further excludes the impact of exchange. Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to Rick.

Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'll discuss our fourth quarter and full year 2020 performance, as well as our expectations for 2021. Mike will then provide an update on recent advancements across our pipeline, and Rob will discuss the quarter and our 2021 guidance in more detail. Following our remarks, we'll take your questions. We delivered another strong quarter with adjusted earnings per share of $2.92, exceeding the midpoint of our guidance by $0.08. Fourth quarter, total net revenues were up nearly 7% on a comparable operational basis. This performance was driven by robust double-digit sales growth from our Immunology, Hemonc, and Neuroscience franchises, as well as 9% comparable operational sales growth of Botox Cosmetic, which is demonstrating a rapid recovery. Our fourth quarter performance tops off another excellent and truly transformational year for AbbVie, which included the successful acquisition and integration of Allergan, creating a stronger and much more diverse AbbVie, with leadership across numerous attractive high-growth markets. Significant contributions from our two new best-in-category immunology medicines, Renvoke and Skyrizzy, which combined for more than $2.3 billion in 2020 sales, their first full year on the market. We expect the combined contribution from RINVOQ and SkyRisi to nearly double in 2021 to approximately $4.6 billion, based on their continued strong uptake in RA and psoriasis, as well as RINVOQ's anticipated approvals in PSA, ankylosing spondylitis, and atopic dermatitis later this year. We delivered continued robust growth from our leading HEMONC portfolio, with Imbruvica and Van Clexta contributing more than $6.6 billion in combined 2020 sales. We expect our HEMONC franchise to grow double digits again in 2021. We also added two compelling oncology pipeline assets, epicritimab, a potential best-in-class CD3 by CD20 bispecific antibody in development for B-cell malignancies, and Limzoparlamab, an anti-CD47 monoclonal antibody being studied in multiple cancers. These two assets will further support the growth of our Hemon franchise across our long-range plan. The acquisition of Allergan brought us a substantial neuroscience portfolio with compelling therapies for migraine and psychiatric conditions, augmenting our already existing neurofranchise. The newly combined neuroscience franchise delivered nearly $4.9 billion in comparable 2020 revenue and is expected to grow double digits in 2021. We also added the leading global aesthetics franchise, a largely cash-paid portfolio with roughly $3.5 billion in comparable 2020 revenues. As I previously noted, this portfolio has demonstrated a rapid V-shaped recovery and we view aesthetics as an extremely attractive long-term growth opportunity. And importantly, we've made excellent progress in 2020 with our pipeline. We expect our R&D pipeline advancements to lead to the approval of more than a dozen new products or indications over the next two years, including a total of six additional indications for Renvoke and SkyRisi, which will cover all of Humira's major indications plus new significant disease areas, including atopic dermatitis. Expanded indications for Van Clexta and Valar, and several new product approvals, including a Tojapan for episodic migraine, Novitaclax for myelofibrosis, and ABVV951, a potentially transformative next-generation therapy for advanced Parkinson's disease. These new opportunities will collectively add meaningful revenue growth in advance of the U.S. Humira LOE. We've entered 2021 in a strong position, which is reflected in our revenue and earnings per share guidance. Based on the recent outperformance of our business, we expect full year 2021 comparable operational sales growth of approximately 9.4%. with total AbbVie sales expected to be approximately $1.7 billion above current consensus. And we anticipate 2021 adjusted earnings per share of $12.32 to $12.52, representing growth of 17.6% at the midpoint. This level of guidance represents impressive performance with nearly all aspects of our business expected to perform at or above current consensus for 2021. The Allergan integration continues to go very well. The transition has been seamless, despite the size of the transaction and the timing of the COVID pandemic. While we're making excellent progress against our expense synergies, which Rob will cover in more detail here momentarily, It remains increasingly clear to us that there are significant opportunities for long-term revenue contributions across numerous Allergan growth platforms. As we recently disclosed, we believe UBrelvy, the first to market in leading oil CGRP for acute migraine, represents a $1 billion-plus peak sales opportunity. I told you, Pat. A potential once-daily oral treatment for the prevention of episodic and chronic migraine also represents a $1 billion plus peak sales opportunity. We expect Baylor's peak sales to approach $4 billion within its currently approved indications of schizophrenia, bipolar I disorder, and bipolar depression. With major depressive disorder, or MDD, representing a potentially significant incremental growth opportunity. Anesthetics, which is poised to regain its growth trajectory this year, is expected to generate high single-digit revenue growth over the next decade. We continue to closely monitor the COVID dynamics, which will have an impact on our business again in 2021, predominantly in the first half of the year, but significantly moderated from the 2020 impact. And despite the recent COVID resurgence within select geographies, we feel the global healthcare system is much better equipped with COVID treatment protocols and PPE to safely see and treat patients throughout the current year. That said, some therapeutic areas continue to be more impacted than others, like CLL, HCV, certain hospital-based procedures, among others, which we have contemplated in our 2021 guidance. Overall, we've been pleased with the rate of recovery across our business, a testament to our differentiated product profiles and our commercial execution. So, in summary, we've assembled an impressive set of growth assets, and the outlook for Abby's business remains strong. With RINVOC and SkyRisi expected to contribute more than $15 billion in risk-adjusted sales by 2025, and our expectations for continued robust growth across T-Monk, neuroscience, and aesthetics, we have a high degree of confidence that we will be able to successfully absorb the Humira LOE impact in 2023, support an immediate return to total sales growth in 2024, and produce compelling, high single-digit compounded annual total sales growth in 2025 through the remainder of the decade with the diversified portfolio and pipeline that we have today. With that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike? Thank you, Rick.