AbbVie Inc.

Good morning and thank you for standing by. Welcome to the AbbVie Fourth Quarter 2019 Earnings Conference Call. All participants will be able to listen only until the question and answer portion of the call. And you may ask a question by pressing star 1 on your touchtone 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. 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. Abdi 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 2018 annual report and on Form 10-K and in our other SEC filings. AbbVie 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, and our earnings release and regulatory filings from today which can be found on our website. Please note that we have also posted some slides to our website to supplement some of the content we'll be covering this morning. 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 2019 performance, as well as our 2020 expectations for AbbVie on a standalone basis. We will provide combined AbbVie and Allergan guidance after the close of the planned transaction. Mike will then provide an update on recent advancements across our R&D programs, and Rob will discuss last year's performance and our 2020 guidance in more detail. Following our remarks, we will take your questions. We delivered another strong quarter with adjusted earnings per share exceeding the midpoint of our guidance. Our adjusted EPS of $2.21 represents growth of more than 16% versus the fourth quarter of 2018. Total adjusted operational sales growth of 5.3% was also ahead of our expectations for the quarter, driven by continued strong performance in both immunology and hematological oncology. Our performance this quarter tops off another strong year for AbbVie. For the full year 2019, we delivered adjusted earnings per share growth of 13%. We have driven strong commercial, operational, and R&D execution, which has allowed us to substantially grow through the impact of international biosimilar competition. We saw excellent performance in our hematological oncology business, which drove operational growth of more than 39% in the year. we have built a substantial franchise with Imbruvica and Benclexta, which combined nearly $5.5 billion in combined revenue with strong double-digit growth expected once again in 2020. Imbruvica remains the clear market share leader across all lines of therapy and CLL. With the largest body of clinical evidence, a robust survival benefit, and the highest category rating in treatment guidelines today, we remain confident Ambrubica will be a significant growth contributor for many years to come. And Klextel will also contribute substantially to our growth in 2020. with continued share expansion expected in both the broad relapsed refractory and frontline CLL segments, as well as continued penetration in frontline AML. In our immunology business, the launches of Skyrizzy and RINVOC are going exceptionally well. Both Skyrizzy and RINVOC have demonstrated strong differentiated efficacy in their initial indications, and we are making considerable progress to expand their uses in several additional immune-mediated diseases. Skyrizzy is already having an impact on AbbVie's growth, with sales of approximately $215 million in the fourth quarter, which already equates to an annualized run rate approaching $900 million, and we expect robust growth in 2020. The launch execution has been nothing short of exceptional. In a very short timeframe, SkyRizzi has established the leading in-play psoriasis patient share, which includes both new and switching patients at roughly 25%. SkyRizzi is redefining the standard for efficacy and safety in the psoriasis market, where it has not only demonstrated superiority to Humira, the gold standard of care for but also outperformed other novel agents, including Cosentix. Skyrizzy's commercial access is now at parity to Chimera and above 95%. While still early in the launch, we're also seeing robust demand trends for RINVOC, which is performing well ahead of comparable analogs in the RA segment. In the first full quarter, Renvoke was on the market. We estimate more than 7,600 prescriptions were filled, including both paid prescriptions and those who received Renvoke through our bridge access program. Based on this level of prescription volume, Renvoke is currently capturing approximately 9% of in-play RA patients and has surpassed the in-play share for several other established brands. The cannibalization of Chimera market share in this segment remains very low thus far. Feedback from prescribing positions has been very positive, and the strong benefit-risk profile Renvoke has demonstrated across our registrational trials has supported very rapid and broad formulary coverage for Renvoke. Commercial access for Renvoke is now at more than 95%. and we expect paid prescription volume to increase significantly throughout 2020 as a result. Humira in the U.S. continues to generate strong revenue, driving more than a billion dollars of growth in 2019 and will remain a significant contributor to growth again in 2020. The international Humira dynamics remain consistent with our expectations, with 2019 revenues down roughly 28% on an operational basis. Overall, I'm extremely pleased with the performance and the outlook for our immunology franchise. We had previously commented that Skyrizzy and RIMVOC would deliver more than a billion dollars of revenue combined in 2020. Our 2020 guidance now contemplates that these two products will contribute approximately $1.7 billion in revenue together this year. Since our inception, we have focused on building a robust pipeline and adding growth platforms that will allow AbbVie to absorb the eventual impact of biosimilar competition in the U.S. and maintain a strong and growing business. we continue to make excellent progress against that objective. As I just highlighted, the better-than-expected launch trajectories of Skyrizzy and Rynvoke and the continued strong performance of our hematological oncology franchise has further increased our level of confidence that these platforms will drive significant growth over the long term. Our R&D productivity over the past seven years has resulted in numerous new products which collectively contributed approximately $9 billion in revenue in 2019. And our R&D pipeline continues to develop nicely with multiple programs well underway to expand the breadth of indications for SkyRizzie and Renvote, as well as the advancement of a significant number of early and mid-stage programs. six of which will have proof-of-concept data readouts in 2020. AbbVie's R&D pipeline has been phase-gated from the time we launched as an independent company back in 2013. Our initial priority was to develop next-generation assets that would be superior to Humira and other competitive alternatives within our key immunology disease areas. And as you have seen, Skyrizzy and RIMVOTE have demonstrated that type of performance across multiple clinical trials. Their successful launch trajectories demonstrate the value of these assets in two very large segments of immunology, which combined represent approximately 40% of U.S. Humero revenues today. we continue to rapidly progress the development of these assets in the remaining key humerid disease areas, as well as new indications, such as atopic dermatitis. Our second priority was to build our hematological oncology franchise into a major growth engine for the company, and Provogem and Klexta have become roughly a $5.5 billion franchise and growing rapidly. and we continue to expand these medicines into important new disease areas, such as multiple myeloma with Venclexta in the T1114 biomarker-defying patient population, and combination therapy with Imbruvica and Venclexta, which have the potential to provide even deeper and more durable responses. The third priority was the development of a robust early and mid-stage pipeline. which now has nearly 40 clinical programs ongoing, including novel new mechanisms developed by AbbVie scientists, as well as assets we are advancing across our many collaborations, such as Calico. The most advanced programs in our mid- to late-stage pipeline, which we expect to be approved by 2022, include Novitaclax for myelofibrosis, ABBV951 for the treatment of advanced Parkinson's disease, and Voliparib for the treatment of ovarian cancer and BRCA breast cancer. These approvals are on top of the numerous new opportunities expected for RINVOTE, Skyrizzy, and Venclexta. Over this same period of time, we anticipate approximately 30 proof-of-concept readouts from novel programs in our early-stage pipeline which Mike will discuss momentarily. It is truly an exciting time for AbbVie science. Another exciting aspect of our business is the planned acquisition of Allergan, which has significant strategic and financial merit. Allergan will provide AbbVie with highly valuable on-market assets with leadership positions across additional attractive growth segments, including new growth platforms and aesthetics, and CNS Neuroscience. The acquisition will further diversify AbbVie's revenue and payer mix and immediately accelerates the standalone scale of our non-Humera business, the AbbVie Growth Platform, which is expected to drive high single-digit annual growth revenue over the next decade and beyond. The proposed acquisition is proceeding well. We recently received conditional approval from the European Commission The FTC review continues to advance following the divestiture announcements for both Zempap and Allergan's IL23. And we have completed the integration planning process, including confirmation of our synergy objectives. We remain on track for closing the Allergan transaction as expected in the first quarter of 2020. We've entered 2020 successfully. with very strong momentum, and we're committed to delivering strong results, which is reflected in our guidance. We expect full year 2020 adjusted earnings per share of $9.61 to $9.71, representing growth of 8.1% at the midpoint. As I mentioned earlier, this guidance reflects ADDI on a standalone basis. We will provide pro forma guidance for 2020 following the close of the Allergan transaction. So, in summary, as you can see from our 2019 results and our 2020 guidance, the performance of AbbVie's business remains very strong. That performance, combined with a late-stage pipeline which includes more than 20 new medicines and major new disease indications, as well as a robust early stage pipeline, gives us significant confidence in the future outlook of our company. The AbbVie business will be even stronger and more diverse with the Allergan transaction. We look forward to another successful year and to welcoming our Allergan colleagues to the new AbbVie in the near future. With that, I'll turn the call over to Mike for additional comments on our R&D program. Mike?