AbbVie Inc.

Good morning and thank you for standing by. Welcome to the AbbVie fourth quarter 2021 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 one on your phone. I would now like to introduce Ms. Liz Shea, Vice President, Head 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, Rob Michael, Vice Chairman, Finance and Commercial Operations and Chief Financial Officer, and Jeff Stewart, Executive Vice President, Chief Commercial Officer. Joining us for the Q&A portion of the call is Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer, and Corporate Secretary. Before we get started, some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties 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 SEC filings. AbbVie undertakes no obligation to update these forward-looking statements except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's 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 ZenPAP 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 provide perspective on our overall performance and outlook, and then Jeff, Mike, and Rob will review our quarterly business highlights, pipeline progress, financial results, and guidance for 2022 in more detail. Our performance this quarter tops off another excellent year for AbbVie, with results well above our initial expectations. We delivered full year 2021 adjusted earnings per share of $12.70, representing growth of more than 20% versus the prior year. Full year adjusted net revenues were more than $56 billion, up 10.5% on a comparable operational basis. These results demonstrate balanced performance across each of our major growth franchises, including double-digit comparable operational revenue growth from immunology, aesthetics, and neuroscience. I'm extremely pleased with our momentum, and we've entered this year in a strong position, which is reflected in our guidance. We anticipate 2022 adjusted earnings per share of $14 to $14.20. representing growth of 11% at the midpoint. Longer term, we remain well positioned with an impressive set of diversified growth assets. In immunology, SkyRisi and RINFOC are already contributing meaningful revenue, including $4.6 billion in combined sales last year with substantial growth anticipated in 2022 and beyond. Over the next few months, we expect to add several new indications to the list of approved uses for these two assets, at which point Skyrizzy and RINVOQ will be commercialized across all of Humira's major indications plus atopic dermatitis. With the strong performance that we're seeing in their initial indications and the robust data we've demonstrated across our broad development programs, we expect combined peak sales for Skyrizzy and RINVOQ to exceed the peak revenues achieved by Humira. In hematological oncology, we've established a leading position with Imbruvica and Benclexta, which are both expected to remain important revenue contributors through the decade. To support our next wave of growth, we also have an exciting and diverse pipeline of promising new therapies to address critical unmet needs in both blood cancers and solid tumors. Notable opportunities from our mid- to late-stage oncology pipeline include nevitaclax from myelofibrosis, which has the potential to provide disease modification in a market where current treatments only address symptoms, epacritimab, a potentially best-in-class CD3 by CD20 for B-cell malignancies, including DLBCL and follicular lymphoma, ABVV383, are BCMA, CD3 bispecific, which has the potential to become a best-in-class treatment in multiple myeloma, and TelisoV, our promising CMET-ADC being studied for non-squamous, non-small-cell lung cancer, which was recently granted breakthrough therapy designation. In neuroscience, We have a portfolio of compelling and differentiated therapies to support robust long-term growth in migraine, Parkinson's disease, and psychiatric conditions. Ubrelvi and QLIPTA are both demonstrating strong launch trajectories in migraine, with each treatment expected to contribute more than a billion dollars in peak sales. VALAR continues to have a significant opportunity with currently approved indications with peak sales expected to approach $4 billion. An approval in major depressive disorder represents upside to our current projections. In 951, a potentially transformative improvement to our current treatment options for patients with advanced Parkinson's disease with peak sales also anticipated to be more than $1 billion. Our leading aesthetics portfolio represents another extremely attractive growth opportunity. This business is performing well above expectations, delivering full-year 2021 sales of more than $5.2 billion, $700 million higher than our initial guidance. AbbVie's increased promotional investment are driving accelerated category growth, especially in toxins and fillers, where there is substantial room for additional market penetration globally. Dedicated resources are also focused on delivering new product innovation within aesthetics, with several exciting R&D programs internally, including both short-acting and long-acting toxins, as well as novel fillers with biostimulatory or regenerative features. And we remain active with business development to pursue promising external technologies, and complementary opportunities, including the recently closed Soliton acquisition, which further expands our body contouring portfolio. Given this focus and investment, we expect our aesthetics franchise to deliver high single-digit revenue growth through the end of the decade, including sales of more than $9 billion in 2029. Lastly, we've developed a robust pipeline including numerous attractive late-stage programs, novel early-stage therapies, and a growing range of potential platform technologies, which we expect will collectively contribute to our growth through the decade. With the actions that we've taken to diversify our sources of growth, we remain very confident in the long-term outlook for our business. Following the US Humira LOE event in 2023, We expect to quickly return to growth in 2024 and deliver a high single-digit growth from 2025 to the end of the decade. This is a testament to the strength of AbbVie's broad and balanced portfolio. In summary, this is an exciting time for our company. We're demonstrating excellent execution across our portfolio, and our long-term growth prospects remain very strong. With that, I'll turn the call over to Jeff.