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AbbVie Inc.
11/1/2019
Good morning, and thank you for standing by. Welcome to the AbbVie Third Quarter 2019 Earnings Conference Call. All participants will be able to listen only until the question and answer portion, 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 of 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 Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer, and Corporate Secretary. 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 statements. Additional information about these risks and uncertainties is included in our 2018 Annual Report on Form 10-K and in our other FCC 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 AbbVie's ongoing business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures and our earnings relief 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 third quarter performance and highlights, as well as our four-year guidance, which we are raising again 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'll take your questions. AbbVie delivered another outstanding quarter with adjusted earnings per share. of $2.33, representing growth of nearly 9% versus last year, and exceeding the midpoint of our guidance by 4 cents. Total revenue of $8.4 billion was also ahead of our expectations for the quarter, driven by continued strong performance in hematological oncology and immunology. I'll start with our HEMOC business, which delivered operational sales growth of 38.5% in the quarter. Imbruvica continues to perform exceptionally well with global revenue of more than $1.2 billion in the quarter, an increase of nearly 30% versus last year. Imbruvica has a strong position across multiple indications and remains the clear market share leader across all lines of therapy in CLL. We're especially pleased with the recent inflection in the frontline setting. driven by Imbruvica's growing body of clinical evidence, label augmentation, and update to treatment guidelines. We're also seeing a substantial contribution from Venclexta, with total revenue of more than $200 million in the quarter. Venclexta continues to expand new patient share in the broad relapsed-repractory CLL segment, and we're making very good progress with our recent approvals for frontline CLL and AML. Now turning to immunology, where we've strengthened our leadership position with the introduction of two new best-in-class therapies, Skyrizzy and RIMVOC, creating a broad portfolio of therapies well-positioned to further improve patient care. We continue to see excellent performance from Skyrizzy with total revenue of approximately $90 million in the quarter. The launch is going extremely well with prescription trends that continue to remain well above recent launch analogs in the psoriasis category. Through the first six months on the market, we already have approximately 3,500 prescribing physicians and more than 9,000 patients treated with Skyrizzy, including those in our Bridge Access Program. And in this short timeframe, Skyrizzy has already established its position as the leader for in-play psoriasis patient share. This includes both new patients and switching patients. In addition, commercial access for SkyRizzi is now at more than 80%, a testament to its best-in-class product profile. We continue to expect SkyRizzi to drive significant growth over our long-range plan. In the quarter, we also announced the approval of upatacitinib, known as RINVOC in the U.S., for the treatment of adult patients with moderate to severe rheumatoid arthritis. This approval marks yet another major milestone for AbbVie, the 14th new product or major indication approval in the last five years and continues to demonstrate our commitment and our leadership in immunology. With a strong benefit-risk profile demonstrated across our registrational trials, RINVOC offers meaningful advantages over products on the market today or in development for rheumatoid arthritis. Feedback from prescribing physicians has been very positive, and we have a highly experienced immunology commercial organization to support a strong launch trajectory. The early trends for RINVOC are highly encouraging. and performance has been tracking ahead of comparable analogs within the RA segment. I'll highlight a few recent data points for you. In the month of October, the second full month RINVOC was on the market, we estimate more than 1,400 prescriptions were filled, including both paid prescriptions and those who received RINVOC in our Bridge Access Program. Based on this level of prescription volume, Renvoke is currently capturing approximately 6% of in-play RA patients. After less than 90 days on the market, Renvoke's in-play patient share has surpassed Remicade and several other established products and is rapidly approaching the in-play share for Emeril. We're also seeing very little cannibalization of Humira market share thus far. Commercial access is ramping strongly and in line with our expectations. By early January, we expect GreenVote to have commercial access above 75%, and we expect paid prescription volume to increase significantly as this access expands over the next several months. So while we're still early in the launch, we're certainly pleased by the feedback we've received from the field, from physicians, and the robust demand trends that we are seeing. Now turning to Humira. Humira grew 9.5% in the U.S. this quarter, driven by continued strong volume growth across all three segments, room, derm, and gastro. International Humira sales were down approximately 32% 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. Based on the continued strong momentum of our business in the quarter and the progress year to date, we are once again raising our full-year 2019 EPS guidance. We now expect adjusted earnings per share of $8.90 to $8.92, reflecting growth of 12.6% at the midpoint, which remains at the top tier of our peer group. I'm extremely pleased with the underlying performance of our business. Additionally, with the planned acquisition of Allergan, we will be adding highly valuable on-market assets with leadership positions across additional attractive growth segments, including significant new growth platforms in medical aesthetics and CNS. The proposed acquisition is proceeding as expected, with the recent successful completion of the Allergan shareholder vote who approved the transaction and advancing regulatory reviews around the globe. Integration planning is also well underway, and we have made substantial progress. We remain on track for closing in the first quarter of 2020. The Allergan transaction has significant strategic merit, and the new AbbVie is poised to deliver top-tier financial performance. Combined, we will generate significant earnings and cash flow to enhance our innovative R&D platform, support a strong and growing dividend, and rapidly pay down debt. As noted in our press release today, we are announcing a 10.3% increase in our quarterly cash dividend. from $1.07 per share to $1.18 per share, beginning with the dividend payable in February 2020. Since our inception, we have grown our quarterly dividend by 195 percent. So, in summary, we continue to demonstrate strong momentum, and I'm extremely pleased with our execution across the portfolio, including the progress that we're making with the recent new product launches and our pipeline advancement. We have assembled an impressive set of growth assets, and the outlook for our business remains strong. The Allergan transaction will make us even stronger and more diversified. We remain focused on achieving our long-term strategic vision for the company, delivering industry-leading performance and outstanding shareholder value while improving patients' lives. With that, I'll turn the call over to Mike for additional comments on R&D programs. Mike?
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