Operator
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Third Quarter 2018 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will be given at that time. As a reminder, this conference is being recorded. I'd now like to turn the conference over to our host, Mr. David Ricks. Please go ahead. David A. Ricks - Eli Lilly & Co.: Thank you and good morning. Thank you for joining us for Eli Lilly & Company's Q3 2018 Earnings Call. I'm Dave Ricks, Lilly's Chairman and CEO. Joining me on today's call are Josh Smiley, our Chief Financial Officer; Dr. Dan Skovronsky, the President of Lilly Research Labs and our Chief Scientific Officer; Enrique Conterno, the President of Lilly Diabetes and Lilly U.S.A.; Christi Shaw, the President of Lilly Bio Medicines; and Anne White, who is joining us for the first time as our new President of Lilly Oncology. We're also joined by Kristina Wright, Mike Suppar (1:09), Kevin Hern, and Phil Johnson of the IR team. Please note that Jeff Simmons is not on the call today, as Elanco is now having their own quarterly earnings calls, including their first call earlier this morning. Substantive questions regarding their business performance and outlook should be directed to Elanco's Investor Relations team. During this call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to a number of factors, including those listed on slide 3 and those outlined in our latest forms 10-K and 10-Q filed at the SEC. Information we provide about our products and our pipeline is for the benefit of the investment community. It is not intended to be promotional. And it is not sufficient for prescribing decisions. We continued our strong performance in 2018 with a third quarter revenue growth of 7% and non-GAAP operating income of 29% and non-GAAP EPS growth of 32%. New pharmaceutical products, which now represent 35% of human Pharma revenue in the quarter, continue to be the driver of our worldwide growth, led by Trulicity, Taltz, and Verzenio. New products continue to drive strong volume-based growth, highlighted by the 14% Pharma volume growth and the 30% U.S. diabetes volume growth. We continue to expand our margins this quarter. Excluding the effect of FX on international inventory sold, non-GAAP gross margin as a percent of revenue increased by nearly 110 basis points over Q3 2017. And non-GAAP operating income as a percent of revenue increased by over 380 basis points to 28.1%. We made significant progress with the pipeline this quarter, including the approval and launch of Emgality in the U.S., a positive CHMP opinion for Emgality in Europe, the submission of lasmiditan in the U.S., as well as positive Phase 3 readouts for Ultra Rapid Lispro in Type 1 and Type 2 diabetes patients, and a positive Phase 2 readout for GIP/GLP, which is now called tirzepatide, in Type 2 diabetes. And we announced yesterday that Trulicity demonstrated superiority in the reduction of major adverse cardiovascular events across a broad range of people with Type 2 diabetes in the precedent setting REWIND trial. These results are important for the millions of people with Type 2 diabetes who face a higher risk for CV disease. We will submit these data to regulatory authorities and plan to present the detailed data at ADA in 2019. These extensive data, along with Trulicity's proven powerful efficacy, simply delivered, further validate Trulicity as a well-established option for people with diabetes. In terms of capital deployment, Elanco Animal Health became a publicly-traded company via a well-received initial public offering. Through the IPO and the associated debt offering, Elanco raised over $4 billion in capital, the vast majority of which was provided to Lilly as partial consideration for the Animal Health business that Lilly transferred to Elanco in connection with the IPO. We announced several business development transactions, including a licensing agreement which Chugai Pharmaceuticals for an oral GLP-1 agonist; a licensing and research collaboration with Dicerna Pharmaceuticals, utilizing their RNAi technology platform; a collaboration with NextCure Inc., focused on discovery and development of novel immuno-oncology cancer therapies; and we purchased a priority review voucher. We returned nearly $600 million via the dividend. And we repurchased $1 billion of stock. Moving on to slides 5 and 6, you'll see more detail on key events since our July earnings call. Now I'll turn the call over to Josh to review our Q3 results and to provide an update on our financial guidance for 2018. Joshua L. Smiley - Eli Lilly & Co.: Thanks, Dave, and good morning. Slide 7 summarizes our presentation of GAAP results and non-GAAP measures, while slide 8 provides a summary of our GAAP results. I'll focus my comments on our non-GAAP adjusted measures to provide insights into the underlying trends in our business. So please refer to today's earnings press release for a detailed description of the year-on-year changes in our third quarter GAAP results. Looking at the non-GAAP measures on slide 9, you'll see the revenue increase of 7% that Dave mentioned earlier. Gross margin as a percent of revenue increased to 76.7%. Excluding the effect of foreign exchange rates on international inventory sold, gross margins as a percent of revenue increased nearly 110 basis points, primarily driven by manufacturing efficiencies and, to a lesser extent, the favorable impact of product mix, partially offset by the negative impact of price on our revenue. Total operating expense increased roughly 1%, with marketing, selling and administrative expense increasing 2%, while R&D expense remained relatively flat. Total operating expense as a percent of revenue compared to Q3 2017 declined 275 basis points to 48.8%, benefiting from previously announced actions taken to reduce the company's cost structure. Operating income increased 29% compared to Q3 2017, which put our operating margin at 27.9% for the quarter. And as Dave mentioned earlier, excluding the effect of FX on international inventory sold, our operating income was 28.1% of revenues, an improvement of over 380 basis points versus last year's quarter. Other income and expense was expense of $15.4 million this quarter, compared to income of $49.9 million in last year's quarter. Our tax rate was 15.1%, a decrease of 380 basis points compared with the same quarter last year, driven primarily by the impact of U.S. tax reform. At the bottom line, net income increased 29%, while earnings per share increased slightly faster at 32%, due to a reduction in shares outstanding from share repurchases. We achieved this significant earnings growth by delivering high single digit revenue growth, while carefully managing our operating expenses, significantly improving profitability again this quarter. Slide 10 details these same non-GAAP measures for September year to date, while slide 11 provides a reconciliation between reported and non-GAAP EPS. You will find additional details on these adjustments on slides 23 and 24. Moving to slide 12. Let's take a look at the effect of price rate and volume on revenue growth. This quarter, foreign exchange had a modest effect on revenue. Our worldwide revenue growth on a performance basis was 8%, driven by a 12% increase in volume, partially offset by price. Q3 represented the seventh straight quarter our human Pharma business delivered volume growth in each major geography. U.S. Pharma revenue increased 11%, driven by impressive volume growth of 17%, led by Trulicity, Basaglar, Taltz and Verzenio, partially offset by price. As Dave mentioned earlier, our U.S. diabetes business delivered 30% volume growth yet again this quarter. This performance affirms our volume based growth strategy is critical as we grow through an evolving U.S. pricing environment. You will see U.S. price declined 6% this quarter. Nearly 3 points of the U.S. price decline was driven by new access and corresponding volume for Basaglar in Medicare Part D, which we didn't have in last year's quarter. We also have approximately 2 points of decline associated with increases to our patient affordability and access programs for Taltz and Humalog, which also drove increased volumes. The remaining point of decline is the net effect of changes to estimates in rebates and discounts across segments, partially offset by the impact of price increases we took late last year and early this year. Moving to Europe, Pharma revenue grew 1%, driven by volume, largely offset by price. This volume growth was achieved despite the loss of exclusivity for Cialis. Excluding the impact of the Cialis LOE, volume grew over 15%. This robust volume growth was led by Olumiant, Trulicity, Taltz, Lartruvo, and Jardiance. In Japan, Pharma revenue decreased 2%, with volume growth more than offset by price from the impact of the biannual price cuts, which took effect in Q1. Volume growth was driven by new products, namely Trulicity, Olumiant, Taltz, and Jardiance, with a significant contribution also coming from Cymbalta. Our Pharma revenue in the rest of the world increased 15% on a performance basis this quarter, led by volume growth from new products, namely Trulicity, Cyramza, Jardiance, Lartruvo, Taltz, and Basaglar, as well as strong volume growth from Humalog. Turning to Animal Health. Total worldwide revenue grew 6% on a performance basis this quarter, driven by higher prices and higher volume. Higher sales of Companion Animal Disease Prevention, Ruminants and Swine, and Companion Animal Therapeutics products were partially offset by lower sales of products that are being exited, including the products which Lilly has retained control of after the Elanco IPO. Slide 13 outlines this same information for our September year-to-date results. Now let's take a look at the drivers of our 12% worldwide volume growth on slide 14. In total, our new products, including Trulicity, Taltz, Basaglar, Verzenio, Olumiant, Jardiance, Lartruvo, and Cyramza were the engine of our worldwide volume growth. You can see that these products drove 13.8 percentage points of volume growth this quarter. This robust Pharma volume growth represented our strongest quarterly volume performance this decade. The loss of exclusivity for Strattera, Effient, Zyprexa, Axiron, Evista, and Cymbalta provided a drag of 110 basis points, while Cialis accounted for 190 basis points of volume decline. At the end of September, generic versions of Cialis entered the U.S. market, which is expected to result in rapid erosion of sales. When excluding LOEs and Cialis, the rest of our products had volume growth of approximately 19%. Slide 15 provides a view of our new product updates. In total, these brands generated nearly $1.9 billion in revenue this quarter, representing 31% of our total worldwide revenue and 35% of our human Pharmaceutical revenue. With the launch of Emgality and the submission of lasmiditan, we look forward to adding a fourth leg to our new product growth story, joining recent launches in diabetes, oncology, and immunology, and demonstrating that Lilly is also building an innovative pain franchise. Moving to slide 16. Continuing with our non-GAAP explanations, this quarter, the effective FX had a relatively minimal impact on our income statement with a small negative impact on revenue and a small positive impact on earnings. Turning to our 2018 financial guidance on slide 17, you will see that we've updated our non-GAAP guidance to reflect our continued strong operational performance. We're narrowing the range for revenue to $24.3 billion to $24.5 billion; narrowing the range for SG&A expense to $6.3 billion to $6.5 billion; decreasing our tax rate from 17% to 16%, due primarily to recently issued guidance on elements of U.S. tax reform; and we're raising and narrowing our non-GAAP earnings per share range to $5.55 to $5.60. At the midpoint of the range, this represents an increase of 30% over 2017. I would note that this revised EPS range assumes a $0.02 to $0.03 negative impact from backing out the noncontrolling interest portion of Elanco profits in the fourth quarter, which had not been included in the prior guidance. Our updated guidance implies fourth quarter non-GAAP EPS of between $1.33 and $1.38, which exceeds current consensus. However, it is lower than our third quarter EPS due to the entry of generic competition for Cialis in the U.S. in late September; higher fourth quarter R&D expenses to support additional late stage investment, including mirikizumab, Olumiant, and Taltz NILEX, as well as pegilodecakin and GIP/GLP; and launch investments for Emgality; and finally the minority interest attributed to Elanco that I mentioned earlier. On a reported basis, earnings per share for 2018 is now expected to be in the range of $3.13 to $3.18 (sic) [$3.04 to $3.09] (14:22). In total, we expect strong full year performance led by volume gains in our new products, which allows for targeted investments in our long-term portfolio and positions us well to achieve our 2020 financial objectives. This robust performance, along with the capital raised from the Elanco transaction, provides strong cash flow, which we are deploying thoughtfully across our capital allocation priorities. As we move forward in line with our strategy, we will continue to prioritize funding our existing marketed products, new launches, lifecycle opportunities, and in replenishing our pipeline. In addition, we continue to leverage business development to upgrade our pipeline and future growth prospects, as you saw with several recent announcements of business development deals. Finally, we'll return excess cash to shareholders via increases to the dividend and share buybacks. Now I will turn the call back over to Dave to review the pipeline and key future events. David A. Ricks - Eli Lilly & Co.: Thanks, Josh. So Slide 18 shows select pipeline opportunities as of October 30. In my summary of the quarter at the beginning of the call, I mentioned the positive movements for Emgality and lasmiditan. Additional movements since our last earnings call includes, the start of a Phase 3 study for Olumiant in lupus; and the start of a Phase 2/3 adaptive study for Olumiant in alopecia areata; the attrition of Cyramza's second line bladder cancer indication from Phase 3; and the attrition of the N3pG plus BACE combo arm from the ongoing Phase 2. Please note, we are still studying N3pG as a monotherapy in Phase 2. On slide 19, we provide an update on expected key events for 2018. In addition to the pipeline movement and regulatory actions I have already noted, you will see that we've added a new line to reflect our expectation to submit Taltz for axial spondyloarthritis to regulatory authorities by the end of the year. In addition, the FDA has granted breakthrough designation to Emgality for the cluster headache indication. And you'll see that we've added a new line to reflect our plans to submit this indication by year end. Under regulatory action, you will see the approval of Verzenios in Europe and Verzenio in Japan and the approval of fruquintinib in China under the trade name Elunate. Under regulatory submissions, you'll see the submission of a new indication for Cyramza in Europe and Japan for second line liver cancer. In the Phase 3 data presentations and publications section, we reflect the presentations at EASD of the EASE 2 and 3 studies in type I diabetes for empagliflozin, as well as the CARMELINA CV outcome study for Tradjenta in collaboration with Boehringer Ingelheim. In addition to the presentations at ACR of the COAST-V and COAST-W axial spondyloarthritis studies for ixekizumab. And in Phase 3 top line data disclosure section, in addition to the Phase 3 readouts for Trulicity and Ultra Rapid Lispro, which I mentioned earlier, we also had a positive Phase 3 readout for flortaucipir, our tau imaging agent. This was another productive quarter, contributing to continued pipeline advancement in 2018. Before we go to the Q&A section, let me briefly sum up the progress we made this quarter. In Q3, we continued our strong operating performance in 2018, delivering 7% revenue growth and 12% volume growth, driven by our newest products. As Josh stated earlier, our Pharma volume growth was the strongest this decade. We continue to realize significant efficiencies in our cost structure, leading to operating margin expansion of over 380 basis points, excluding the impact of foreign exchange on international inventory sold. We have made excellent progress in our pipeline this quarter as well: The approval and launch of Emgality for migraine patients in the U.S., this is our 10th new product launch since 2014; the FDA submission of lasmiditan for acute migraine; positive Phase 3 data for Ultra Rapid Lispro; the presentation of exciting Phase 2 data for tirzepatide in type II diabetes; and just yesterday's news that Trulicity demonstrated superiority in the reduction of major adverse cardiovascular events across a broad range of people with type II diabetes in the precedent setting REWIND trial. We also returned $1.6 billion to shareholders via dividend and share repurchases. We completed the Elanco IPO and bolstered our early phase pipeline with the addition of an oral GLP-1, while completing several other business development deals. This concludes our prepared remarks. And now I'll turn the call over to Phil to moderate the Q&A session. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Dave. As in prior calls, we would like to take as many questions as possible during the Q&A session, so we do ask that you limit your questions to two or a single question with two parts. Also, given some scheduling issues on our side and the fact that in recent calls we have not exhausted the full 90 minutes we had scheduled, we do intend to conclude today's call at 10:15. So with that, Lola, if you could provide the instructions for the Q&A session. And then we're ready for the first caller.