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AbbVie Inc.
7/26/2019
Good morning and thank you for standing by. Welcome to the AbbVie Second 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 1 on your phone. And 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. Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary, will join us for the Q&A portion of the call. 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. 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 these risks and uncertainties is included in our 2018 Annual Report on Form 10-K and in our other SEC filings. ADVI 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 ADVI'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.
Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'll discuss our second quarter performance and highlights, as well as our full year guidance, which we are raising again this quarter. Mike will then provide an update on recent advancements across our R&D programs, and Rob will discuss the quarter in more detail. Following our remarks, we'll take your questions. AbbVie once again delivered an outstanding quarter with adjusted earnings per share of $2.26, representing growth of 13 percent versus last year, exceeding our guidance. Total revenues of more than $8.2 billion was also ahead of our 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 nearly 40%. Imbruvica is performing exceptionally well, with robust share growth across multiple lines of therapy in CLL, including new patient share of approximately 35% in the frontline setting, up approximately 10 share points over the past year. This strong momentum directly relates to the growing body of clinical evidence, label augmentation, and recently updated treatment guidelines, which now position Imbruvica as the only preferred therapy in the frontline CLL market. Benclecta also continues to make very good progress in the broad relapsed refractory CLL setting and has established a strong growth trajectory in the recently approved indications for first-line CLL and AML. U.S. Chimera grew more than 7.5 percent versus last year, driven by continued strong volume growth across all segments. And despite a very competitive environment, Humira remains the market leader across each of the three primary categories, Rheum, Derm, and Gastro. During the quarter, we also announced our ninth global settlement agreement resolving all IP-related litigation with BI over their biosimilar Humira. This final settlement agreement reinforces our confidence that we will not see direct biosimilar competition in the U.S. until 2023. International Humira sales were down 31 percent on an operational basis, reflecting the impact of direct biosimilar competition in Europe and other international markets. The international biosimilar trends and dynamics remain consistent with our expectations. And Skyrizzy, our recently approved treatment for moderate to severe plaque psoriasis, is performing significantly above our expectations. contributing nearly $50 million in revenue this quarter. The launch is going extremely well. We are seeing strong prescription volume, well above recent launch analogs in the psoriasis category. Through the first 11 weeks of launch, we already have approximately 1,700 prescribing physicians, and approximately 3,750 patients have been treated with Skyrizzy, including those in our Bridge Access program. We're extremely encouraged by this uptake, which supports our continued confidence in the asset. Commercial access for SkyRisi is also tracking in line with our expectations. As a result of the launch progress and the momentum, we are increasing our full-year guidance for SkyRisi and now expect full-year global sales of approximately $250 million. The outlook for SkyRisi remains very strong. and it represents a significant long-term opportunity for AbbVie with multibillion-dollar peak sales potential. We're also very pleased with our overall commercial performance and financial results for the quarter. 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 EPS guidance and now expect adjusted earnings between $8.82 and $8.92, reflecting growth of 12.1% at the midpoint, which is at the very top of the expectations for our peer group. Clearly, this is an extremely exciting time for AbbVie. Before I turn the call over to Mike and Rob, I want to speak briefly about our proposed acquisition of Allergan and the progress we are making. We've had an opportunity to speak with many investors over the past several weeks since the announcement to share the strategic rationale for the transaction. And our outreach with investors will continue as we have a number of opportunities to engage with shareholders in the coming months. The integration planning is already underway, and we are working to ensure a seamless transition on day one. We've identified individuals within AbbVie that will lead the integration process, and there will be dedicated teams to ensure there is no disruption to our strong momentum. And finally, I'll be meeting with the Allergan employees in the coming weeks. I look forward to engaging with and ultimately welcoming this experienced and very talented organization into AbbVie. We remain incredibly excited about the transaction, which has significant strategic merit. The acquisition represents a unique opportunity for AbbVie to accelerate our non-Humera business, the AbbVie Growth Platform, by adding highly valuable on-market assets with leadership positions across attractive growth segments. AbbVie's new growth platform will achieve stand-alone scale immediately. with sales of more than $30 billion in 2020 and top-tier growth prospects. And it will enable enhanced funding of our innovative R&D platform and provide ample resource for additional pipeline expansion, which remains the core focus for AbbVie. The combination of AbbVie and Allergan will also unlock significant value for our shareholders, as we've outlined. The transaction delivers immediate robust financial benefits, with EPS accretion of 10 percent in the first full year of combination, increasing to above 20 percent at peak. This is inclusive of more than $2 billion in annual pre-tax synergies and cost savings, which is expected in the third year post-closing. This combination also provides significant additional earnings in the period following the loss of Humira exclusivity. And the transaction provides enhanced cash flow to support a strong and growing dividend while rapidly paying down debt and continuing to invest in our innovative pipeline through increased R&D funding and the acquisition of mid- to late-stage assets. And finally, we're actively seeking the relevant approvals for the transaction and are working towards our stated goal for closing in the first quarter of 2020. In summary, we're extremely pleased with our outperformance in the quarter and with the continued strong momentum of our business, leading to another increase in our expectations for 2019. Since 2013, we've built a strong foundation through outstanding execution, and the advancement of a robust pipeline of new innovative medicines. Looking back, we have delivered 16 quarters of double-digit earnings growth and have consistently been among the peer group leaders for revenue and EPS growth. We've launched 13 new products or major indications, which have and will continue to contribute considerably to our growth. While this level of consistent performance is truly exceptional, especially given the challenges which inevitably arise in a large, complex business like ours, the key to long-term, sustainable, strong performance has always been forward planning. And Allergan represents another example of our proactive planning to ensure we will continue to deliver top-tier performance into the next decade. Our strong track record of execution, combined with the momentum of our business, gives us tremendous confidence in our ability to continue to successfully execute our long-term strategy and deliver outstanding shareholder value going forward. With that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike?
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