4/25/2019

speaker
Operator
Conference Operator

Good morning and thank you for standing by. Welcome to the AbbVie First Quarter 2019 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 touchtone phone. I would now like to introduce Ms. Liz Shea, Vice President of Investor Relations.

speaker
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, Bill Chase, Executive Vice President of Finance and Administration, and Rob Michael, Senior Vice President and Chief Financial Officer. Before we get started, I would like to remind you that some statements we make today are or may be considered forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. ADVI 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 statement. Additional information about the factors that may affect AbbVie's operations is included in our 2018 annual report on Form 10-K and in our other SEC filings. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. On today's 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. Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to Rick.

speaker
Rick Gonzalez
Chairman of the Board and Chief Executive Officer

Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'll discuss our first quarter performance and highlights, as well as our four-year guidance, which we are raising this quarter. Mike will then provide an update on recent advancements across the R&D programs, and Rob will discuss the quarter in more detail. Following our remarks, we will take your questions. I'm pleased to report that we're off to an excellent start in 2019, reinforcing our confidence in the long-term fundamentals of our business. We are seeing strong momentum across all aspects of our operations. with excellent growth from our hematological oncology portfolio, continued robust growth from Humira in the U.S., international biosimilar impact is trending within our expectations for 2019, and importantly, our late-stage pipeline continues to deliver with the recent approval of SkyRisi in major markets globally. We delivered first quarter adjusted earnings per share of $2.14, representing growth of more than 14% versus the prior year, and once again exceeding our guidance. Total revenues of more than $7.8 billion were also ahead of expectations for the quarter, with several key products contributing to that growth. We saw excellent performance from our hematological oncology business with global operational sales growth of more than 43%. U.S. Humira grew more than 7% versus last year, driven by continued robust demand. International Humira sales were down 23% on an operational basis, reflecting the impact of direct biosimilar competition in Europe and other international markets. The international biosimilar trends and dynamics have been consistent with our expectations. We also saw substantial contributions from several other products in our portfolio, including Maverick, Creon, and Duodopa. We're certainly pleased with our commercial performance and our financial results for the quarter, and we remain well-positioned to deliver double-digit earnings growth once again in 2019. As noted in our earnings release, we are raising our full-year 2019 guidance and now expect adjusted earnings between $8.73 and $8.83, reflecting growth of 11% at the midpoint. In addition to the strong financial results, we have continued to make significant progress, building a pipeline that will allow us to maintain a growing and vibrant business. Since our inception, we have put tremendous effort and resources towards developing new therapies that advance the standard of care across a spectrum of important disease states. with special emphasis on doing so in a broad range of immune-mediated diseases. Our central focus has been on advancing new medicines that will raise the bar and address important therapeutic needs for patients. We believe that Rizokizumab and Upatacitinib have achieved the objectives that we set forth. Both of these therapies have demonstrated differentiated clinical profiles versus Humira, as well as other mechanisms on the market or those in development. This profile, coupled with our strong commercial execution, gives us tremendous confidence that both will be the new standards of care in their respective indications. We recently announced the approval of rizocasumab, now known as Skyrizi in the U.S. and Japan, for the treatment of adult patients with moderate to severe plaque psoriasis. These approvals mark a major milestone for AbbVie and further demonstrate our commitment and leadership in immunology. We're certainly pleased with the approved label for SkyRisi, which reflects its best-in-category efficacy, favorable benefit-risk, and quarterly dosing. As you know, we also have a highly experienced team, including the leading immunology marketing team, and Salesforce, which will support this launch. Given its compelling product profile, we expect to secure rapid and broad formulary coverage for SkyRisi with more than 50% commercial access by the end of July, a 90-day access metric not achieved by any other recent launch in the psoriasis category. SkyRisi represents a significant long-term opportunity for AbbVie. with multi-billion-dollar peak sales potential. We have also been planning and preparing for the forthcoming regulatory approval and commercial launch of Upatacitinib, our JAK1 selective inhibitor in rheumatoid arthritis. We have been extremely encouraged by the level of efficacy and benefit-risk profile observed across the entire Upatacitinib clinical program. including its clear superiority versus Humira, the current gold standard for the treatment of RA. Based on the data generated across our program, we believe the apatacitinib will offer meaningful advantage over other products on the market today for those in development, and we remain on track for U.S. regulatory decision in the third quarter. With the robust and differentiated data we've produced from our assets and the launch of several new products now underway, we remain confident that the strategy we have in place is working extremely well. We're excited to see the evolution of our pipeline assets from promising late-stage development compounds to successful on-market products. SkyRIZI marks the 12th new product or major indication approval for AbbVie in the last five years, demonstrating the productivity of our R&D investment, which is vital for the long-term success of any innovation-driven biopharmaceutical company like ours. So in summary, I'm extremely pleased with the strong execution and pipeline advancement we're seeing, leading to our increase in expectations for 2019. We're off to an exceptional start of the year, followed by several years of market-leading performance, and we're well-positioned to continue to deliver top-tier financial performance in 2019 and beyond. With that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike?

Disclaimer

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