Earnings Labs

Eli Lilly and Company (LLY)

Q3 2018 Earnings Call· Tue, Nov 6, 2018

$855.89

-2.07%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+3.61%

1 Week

+6.13%

1 Month

+7.73%

vs S&P

+11.75%

Transcript

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…

Operator

Operator

Certainly. And first we'll go to the line of Chris Schott with JPMorgan.

Chris Schott - JPMorgan Securities LLC

Management

Great. Thanks so much for the questions. My first one was on REWIND results. I think you referred to them as precedent setting. I know you're sharing the full data next summer. But any additional color you can provide, as we try to think about those results in context of prior GLP-1 CV outcome studies? As we get kind of this balance of healthier patients versus longer follow-up in that study. My second question, you touched a little bit on the prepared remarks. But the diabetes portfolio in 3Q, I think we had a few progs coming in a bit below expectations after some very strong first half results. Can you just talk about any color in terms of, was there any kind of one-time issues to speak about, Humalog or Basaglar, that affected this quarter's results? Thanks so much. Philip Johnson - Eli Lilly & Co.: Great. Thank you for the questions, Chris. Enrique, those are both for you. Enrique A. Conterno - Eli Lilly & Co.: Very good. REWIND is indeed a precedent setting trial. It included the majority of patients without – with Type 2 diabetes, but without cardiovascular disease. It also had the longest median follow-up, over five years, and a low A1C baseline of 7.3. I think what we can share at this stage is really what's on the press release. We will not be sharing more information on REWIND until our intended detailed presentation at ADA next year. We do intend to submit in 2019 for a new indication. Related to Humalog and Basaglar on the overall diabetes portfolio, first, I think we're very pleased with the overall volume growth when it comes to the diabetes portfolio. Clearly when it comes to Humalog, we did see a 14% price decline vis-a-vis Q3 of 2017.…

Operator

Operator

Certainly. And next, we'll go to the line of Tim Anderson with Wolfe Research.

Timothy Minton Anderson - Wolfe Research, LLC

Management

Thank you very much. A couple of questions. 2019, can you talk about tailwinds and headwinds? I know you won't be giving official guidance until December, but hoping there are at least some trends both on the revenue and spending side that you can maybe call out ahead of that official guidance. So for example, obviously Cialis is – will be LOE. If I think about R&D spend, you're going to be starting eight Phase 3 trials on your GIP/GLP-1 program. So any color on 2019 would be appreciated. And then a second question on insulin category. So at some point, FDA may deem biosimilar insulins as interchangeable and substitutable with brand. Do you think this is more likely than not to occur? And could that be something that happens as soon as 2019? And if not 2019, then when? Philip Johnson - Eli Lilly & Co.: Great. Tim, good to hear your voice again. Welcome back. Josh, if you would answer the first question on the 2019 tailwinds and headwinds. And then, Enrique, the question Tim had on interchangeability for insulins. Josh? Joshua L. Smiley - Eli Lilly & Co.: Yes. Thanks, Tim. And you started to answer the question. I think the main tailwinds – or the headwind that we'll see is the Cialis overhang in 2019, as we will experience the main erosion here in the fourth quarter in the U.S. So that certainly will be a headwind as we head in 2019. That being said, we're seeing great growth in the 10 new medicines we've launch since 2014. So we'd expect that the volume from those products to more than compensate for many of the tailwinds we've said we will see. So we will see a difficult compare. The other thing that we've talked about in…

Operator

Operator

Certainly. Next will go to line of Jason Gerberry with Bank of America. Mr. Gerberry? Shall we move on? Philip Johnson - Eli Lilly & Co.: Yes, if you could. And then maybe put Jason into the next slot if he's able to reconnect? Thank you.

Operator

Operator

Certainly. And next we'll go to the line of Andrew Baum with Citi.

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Thank you. Couple of questions for Enrique, please. Could you talk to the barriers prohibiting broader Jardiance usage? Whether it's education? Reimbursement copay? And then related to that, could you outline the Tier 2 formulary status within Medicare for Jardiance especially? And in particular, whether a second brand at a net price rather than the current list price may be helpful in increasing penetration by reducing the burden on the patients and preparing ground for a world of net pricing, which seems to be potentially upon us? Many thanks. Philip Johnson - Eli Lilly & Co.: Okay. Andrew, thank you for the questions. If I got them, first, Enrique, would be barriers that you see to Jardiance usage and ways to maybe change that, Tier 2 formulary status and Medicare, and the opportunity for a second brand to potentially address some of the issues that patients face in that book of business. Enrique A. Conterno - Eli Lilly & Co.: Yeah. I'm going to try to answer that question, Andrew, just by maybe a bit of color on how we see Jardiance, because I do see there are some barriers. But I see a number of dynamics that are very positive when I look at the overall class and Jardiance in particular. First, clearly one of the things that we look at is, how is the overall class evolving and developing? And the class right now is growing in single digits, high single digits. But more importantly, we are seeing new patient starts – the growth in new patient starts accelerate. We now see that in the 14%, 15% range. It reminds me a bit of the reacceleration of the GLP-1 class back when Trulicity was launched. Importantly, there are new guidelines that have been published by both ADA and…

Operator

Operator

Certainly. And next we'll go to the line of Jason Gerberry with Bank of America.

Jason M. Gerberry - Bank of America Merrill Lynch

Management

Hi. Can you guys hear me? Philip Johnson - Eli Lilly & Co.: We certainly can. Yes.

Jason M. Gerberry - Bank of America Merrill Lynch

Management

Great. Sorry about that. Yeah, first question is just on Taltz. Can you talk about the outlook going into the next few years with a new competitor launching? And do you believe that as these market position with HUMIRA, which has been the leading product in some of these markets, do you think that confers any advantage as it pertains to access relative to the already on market interleukin agents? And then my second question. With oral GLP-1, can you talk a little bit about what you hope to accomplish here, especially with the great data on GIP/GLP? And as we think about Novo's [Novo Nordisk's] oral sema [semaglutide], there are obviously some challenges with that product in terms of dosing. So can you talk about sort of what you're looking for in terms of go, no-go profile? Philip Johnson - Eli Lilly & Co.: Great, Jason. Thank you for the questions. So, Christi, if you'll take question on the Taltz outlook going forward. And then over to you, Dan, for our goals for the oral GLP-1 program. Christi Shaw - Eli Lilly & Co.: Sure. So we're very excited with Taltz. I mean you probably saw that our year-over-year volume growth was significant. And specifically, our TRx grew 80% year over year. And over the quarter, continuing to grow the same. And we're just starting with Taltz. I mean we have a great position in the dermatology office. We just launched this year in the rheumatology office with psoriatic arthritis, which that launch is going well. And just coming off of the American College of Rheumatology, we also demonstrated our data in ankylosing spondylitis, which we will submit before the end of the year, as Dave said. So as we're looking and winning in dermatology, we're beefing up in…

Jason M. Gerberry - Bank of America Merrill Lynch

Management

Great. Thank you. Philip Johnson - Eli Lilly & Co.: Thank you, Dan. Lola, next caller, please?

Operator

Operator

Certainly. And next we'll go to the line of Geoff Meacham with Barclays.

Olivia Brayer - Barclays Capital, Inc.

Management

Hey, guys. This is Olivia Brayer on for Geoff. Thanks for taking the question. Just two from me. First question is on your dual-receptor agonist. Can you provide us with any updates on that Phase 3 trial? We noticed yesterday that the SURPASS 4 was posted to ct.gov. So can you point to what steps you've taken to improve that overall tolerability in that Phase 3? Just curious how the design was influenced by the recently completed titration study that you previously talked about? And of course, the Phase 2 that we saw last month. And any expectations there on enrollment timelines? And then second question is just another on REWIND. Just curious on what your view is on the incremental opportunity here. Any thoughts on how it might change the treatment paradigm? And what the impact on the overall GLP-1 class might be? Thanks so much. Philip Johnson - Eli Lilly & Co.: Great. Thank you for the questions. So, Enrique, maybe we'll have you attack those. So the first one on GIP/GLP or tirzepatide, things that are being done for Phase 3 with titration, things we would have learned in our Phase 2 program, and then any comments on enrollment timing. And then how you see REWIND playing out going forward with the GLP-1 market. Enrique A. Conterno - Eli Lilly & Co.: Yeah. So as we've shared as part of tirzepatide's Phase 3 program, we are planning to study three maintenance doses at 5, 10 and 15 mg. I think what we've learned is that we should titrate in smaller increments and over time. As we've shared, we have a titration study that we intend to share the details next year. But clearly we've learned a lot from the study in terms of what are the optimal titration schedules. We are planning aggressively when it comes to starting this trial and starting enrollment. So you'll be hearing more when it comes to our trial for Type 2 diabetes soon. As far as REWIND, I don't want to speculate on the particular indication that we will get. But clearly, this is important for the class in that it confirms what other GLP-1s have shown when it comes to seeing benefit. And, I'm sorry, I cannot resist, but I heard Novo Nordisk's call. And they also mentioned that GLP-1s were not all the same, and I think we agree with them. Philip Johnson - Eli Lilly & Co.: Thank you, Enrique. So, Lola, if we can go to the next caller?

Operator

Operator

Yes. And next we'll go to the line of Steve Scala with Cowen. Steve Scala - Cowen & Co. LLC: Thank you. I have a couple questions. You mentioned the U.S. price hit from gaining access for Basaglar, Taltz, and Humalog. But was there a one-time volume gain from this reflected in the 17% U.S. volume increase? So that's the first question. The second question is to go back to the questions on REWIND. Is REWIND precedent setting because of the population studied? Or is it precedent setting because you have avoided the less than optimal outcomes of Novo's leader in SUSTAIN 6? Or perhaps both? I mean precedent setting is a big statement. So in the absence of any color, I guess we have to assume you hit all three components of the primary endpoint, which is something Novo was not able to accomplish. Thank you. Philip Johnson - Eli Lilly & Co.: Great, Steve. Thank you for the questions. So, Josh, if you'll take the comment on U.S. price, if there was also offsets there in the volumes that we're gaining. And then, Enrique, on what we mean by precedent setting for REWIND. Joshua L. Smiley - Eli Lilly & Co.: Thanks, Steve. Yes, if you look at volume for the third quarter in the U.S., it grew at 17%, which Dave and I both mentioned was the most significant volume growth we've seen this decade. And that Basaglar absolutely contributed to that growth. So the access that we got in Medicare Part D is contributing to the 17% growth, as are the other elements that we mentioned around patient access and all of the new launches. So it is a positive offset there. And you can see in total, even with that negative-6% growth, the U.S. business grew at 11% overall. Philip Johnson - Eli Lilly & Co.: Great. Thanks, Josh. Joshua L. Smiley - Eli Lilly & Co.: Yeah. Philip Johnson - Eli Lilly & Co.: Enrique? Enrique A. Conterno - Eli Lilly & Co.: As I mentioned when I first discussed REWIND as part of the first question, it is precedent setting because it includes some areas of patients without cardiovascular disease. It has the longest median follow-up and a low A1C baseline. We'll be sharing the detailed results at the ADA next year. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Enrique. Lola, next caller?

Operator

Operator

Next we'll go to the line of Umer Raffat with Evercore.

Umer Raffat - Evercore Group LLC

Management

Hi. Thanks so much for taking my questions. First, maybe on the oncology side, I noticed for your IL-10 you have decent monotherapy activity in the renal cell setting. But the randomized trials you're running are in lung and pancreatic. So I just wanted to get the thought process there. Is that a consideration? And also your confidence on those open-label lung trials that are coming out in the first half 2019. Second, on NGF it seems like the placebo adjusted efficacy definitely faded into the latest readout. And my question is, do you look at this current placebo adjusted efficacy from this latest trial as being clinically meaningful? And also just your thoughts on the joint replacements on that trial. Thank you. Philip Johnson - Eli Lilly & Co.: Great, Umer. Thank you for the questions. So, Dan, we'll go to you for those on the development strategy for the IL-10. And then also what we think about the efficacy results and any safety findings from the initial trial that's readout for our NGF. Daniel M. Skovronsky - Eli Lilly & Co.: Yeah, thanks, Umer, for those good questions. So starting with the pegilodecakin at IL-10. As you point out, the randomized trial that's ongoing at Phase 3 is in pancreas. We're excited about that and look forward to seeing data there in combination with FOLFOX. The two Phase 2 studies that you mentioned are randomized trials in non-small cell lung cancer. The first one is in the first line setting in PD-L1 high patients. And the second one is in the second line setting in the PD-L1 low setting, both in combination with I/O. We're absolutely excited to see data from those trials starting next year, which will inform our progress in that opportunity. As for RCC, you're…

Operator

Operator

Certainly. And next it's Alex Arfaei with BMO Capital.

Alex Arfaei - BMO Capital Markets

United States

Great. Thank you. And congratulations on a positive REWIND readout. First on REWIND, Enrique, June 2019 seems like a long time to wait for the results. You mentioned you plan to file the indication in 2019. So when should we expect to see a new Trulicity label? Then I have a couple of questions on Verzenio, please. The market seems to have slowed down more than we expected. Just wondering if you could give us your thoughts there? You're gaining share, which is great, but what's going on with the overall market? And we noticed you moved up the timeline for the adjuvant study by one year on clinicaltrials.gov. Just wondering if you changed anything about the trial? Or is it just your expectations about, based on the powering of the study or expected benefits? Thank you very much. Philip Johnson - Eli Lilly & Co.: Great. Thank you for the questions, Alex. So timing for a potential label update on REWIND, Enrique, for you. And then, Anne, if you'd to handle what we're seeing for market growth with the CDK4/6 class and the change in timing on clinicaltrials.gov for the adjuvant study. Enrique? Enrique A. Conterno - Eli Lilly & Co.: Well, clearly, we are planning to pursue an indication under a submission in 2019 and a standard review. We will be looking at a label update in 2020. Of course, we are working as fast as we can to try to expedite that as much as possible. And we'll be working with the regulatory authorities. Unfortunately, we won't be able to share the REWIND data prior to ADA. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Enrique. Anne? Anne E. White - Eli Lilly & Co.: Great. Well, thanks for the question on Verzenio. And, yes,…

Operator

Operator

Certainly. Next will be David Risinger with Morgan Stanley. Mr. Risinger? David R. Risinger - Morgan Stanley & Co. LLC: Yeah. Sorry. I was on mute. Can you hear me now? Philip Johnson - Eli Lilly & Co.: We can. Yes, Dave. David R. Risinger - Morgan Stanley & Co. LLC: Okay. Great. So Lilly's volume growth has been and is set to continue to be very strong. But could you please comment on three quick questions on pricing? First, the list price outlook for 2019 that you have in your planning assumptions? Second, your exposure to a step up in the donut hole fill in 2019? And third, your exposure to growth in co-pay accumulators in 2019? Thanks very much. Philip Johnson - Eli Lilly & Co.: Great, Dave. Thank you for the questions. Josh, if you'd like to answer those questions on expectations moving forward on price? Joshua L. Smiley - Eli Lilly & Co.: So, Dave, we'll do our guidance for 2019 in December, and we'll provide our pricing assumptions then. I can tell you for 2018 for the guidance that we gave, we're not assuming any additional price increases this year. In terms of exposure to the change in the donut hole provision, we've said before that when we look across our portfolio, it's about $200 million of incremental impact in 2019. And then on the co-pay accumulators piece, of course these impact the specialty drugs, particularly Taltz and Forteo for now. And we're – at least for where we are right now, we're comfortable that there is not a significant exposure here. David A. Ricks - Eli Lilly & Co.: Just maybe a follow on comment on that. I've seen notes from analysts as well as other industry commentators that, roughly in specialty segments, these are single-digit impacts in terms of patients actually exposed to the out-of-pocket costs of co-pay accumulators, net of industry actions and payer actions. And that's not really different for us with Taltz, which is the major product affected. So it's an issue, but it's not a huge driver of the overall picture. Philip Johnson - Eli Lilly & Co.: Great. Thank you. David R. Risinger - Morgan Stanley & Co. LLC: Thank you, guys. Philip Johnson - Eli Lilly & Co.: Thanks, Dave. Lola, if we can go to the next caller?

Operator

Operator

Certainly. And it will be Vamil Divan with Credit Suisse. Vamil K. Divan - Credit Suisse Securities (USA) LLC: Hi. Great. Thanks for taking my questions. So one just on Olumiant. Looks like still pretty good European uptake, but sort of limited uptake in the first few months on the market in the U.S. So maybe you can just talk about sort of access and sort of initial position interest in that product. And then the other one, I just – maybe a little bit of a different product we don't talk much about is Lartruvo. Obviously, still one of your newer medications. But I think it's asked about a little less. And I'm just trying to get a better sense of that market. I mean the growth is still there in the U.S. but slowing a little bit. And I'm just trying to get a better sense of how penetrated you think that product is into that market. And maybe a little bit more on the longer-term potential for that one to keep growing. Thanks so much. Philip Johnson - Eli Lilly & Co.: Great, Vamil. Thank you for the questions. So, Christi, if you'd like to talk about what we're seeing in terms of uptake access and physician experience here in the U.S. And then, Anne, over to you for what we're seeing with Lartruvo and the market opportunity there. Christi Shaw - Eli Lilly & Co.: Sure. So thank you for the question, Vamil. In terms of Olumiant, I will start with the EU as you suggested, or outside the U.S. The growth of Olumiant in volume in Europe in the last two quarters has actually been the fastest growing in volume for Lilly as a whole. And in Japan, we just were lifted in September on…

Operator

Operator

Yes. It will be Louise Chen with Cantor Fitzgerald.

Louise Chen - Cantor Fitzgerald Securities

Management

Hi. Thanks for taking my two questions. So my first question is on REWIND. Has this met your internal expectation for relative risk reduction? And have you historically talked about what kind of incremental sales opportunity it could mean for you? And then secondly, on the injectable CGRPs, how do you see this market landscape playing out with three approved products and more to come on the injectable and oral side? And do you think it will grow the entire market or take share from existing products? Thank you. Philip Johnson - Eli Lilly & Co.: Great. Louise, thank you for the questions. So, Enrique, another question on REWIND for you. And then, Christi, on the CGRP question, please. Enrique A. Conterno - Eli Lilly & Co.: On the expectations, of course. This is a positive trial. Trulicity is showing superiority in a broad range of patients with Type 2 diabetes. Philip Johnson - Eli Lilly & Co.: Great. Thank you. Christi? Christi Shaw - Eli Lilly & Co.: Yes. So we are extremely excited about the migraine marketplace. I mean you're seeing, as we've been discussing over the last year, the high unmet need with now tens of thousands of patients already being prescribed a preventive now. And I don't think I've talked to you since we actually received our label. So we're really happy with the label we received in terms of our differentiation. We have the 50%, 75%, and 100% migraine-free data that we're able to promote. Also our positive outcome for functional measures, which is unique for Emgality, is in the label. And we just presented data at the American Headache Society that Emgality works fast. Our induction dose, so patients can actually get the medication quickly, and they get it in the doctor's office where they teach them how to do the autoinjector. They do it themselves. And then they go and take it once a month then on. Lastly, the other differentiation is we got the breakthrough therapy designation in cluster. And we're very excited about that for patients who have had no treatment – no approved treatment – in that suicide headache population. So as we look at the marketplace, we see it continuing to grow. We like our chances in terms of being able to compete. And with the competitive agents and oral agents coming out next year, those right now are in a different class that will compete with lasmiditan and not the preventive therapies initially. So with the entire franchise we have in migraine of both preventative and acute, we think we're a leader. And we know we're a leader in pain and migraine and will continue to prove it out over time. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Christi. Lola, if we can go to the next caller?

Operator

Operator

And next we'll go the line of Seamus Fernandez with Guggenheim Securities.

Seamus Fernandez - Guggenheim Securities

Management

Thanks very much for the question. So just a couple. Can you help us understand a little bit the opportunity for Emgality in cluster headache specifically? Is this a large new patient population that we should be thinking about? Or is it more an indication that will firm up and differentiate your market position? And then second, Enrique, can you talk more about the international growth opportunity for the GLP-1 class overall? When I look at the class, we're looking at about a third of sales relative to the U.S. And frankly, when we look at other large classes, the opportunity seems to be like it would be quite a bit greater. And I just would love to know what you see as the opportunity internationally? Or perhaps what the holdbacks are? Thanks so much. Philip Johnson - Eli Lilly & Co.: Great. Seamus, thank you for the questions, and welcome back to you as well. Good to hear your voice on the line. Christi, if you'll take the question on the opportunity for cluster for Emgality. And then, Enrique, for the international growth opportunity for the GLP-1 class. Christi Shaw - Eli Lilly & Co.: Thank you, Seamus, for the question. As I said earlier, we are so excited to help these patients with cluster. And although the number of patients who have cluster is obviously significantly less than the general moderate to severe migraine population, it is such a high unmet need that we're privileged to provide that for patients. And the second part of your question, I think it's good for that. But it's also obviously confirming again the efficacy of Emgality. As I stated before, Emgality is the only one who actually demonstrated efficacy in 100% of – being able to relieve 100% of migraines in any given month. And that efficacy, now coupled with cluster, which is significant and no one has ever showed efficacy, that halo effect across Emgality in migraine we expect will be a benefit. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Christi. Enrique? Enrique A. Conterno - Eli Lilly & Co.: So there is a significant opportunity, just like in the U.S., outside of the U.S. for the GLP-1 class. The GLP-1 class is growing in the mid-20s outside of the U.S. in most markets, so very healthy growth. Something unique when we look at the international markets is the size of the basal insulin market, which, as we know, represents a significant opportunity, as we see GLP-1s being the injectables of choice, first injectables prior to basal insulin. So a very significant opportunity, but we see that playing out over time. Philip Johnson - Eli Lilly & Co.: Thank you, Enrique. Appreciate it. If we can go to the next caller, please, Lola?

Operator

Operator

Certainly. It'll be Steve Scala with Cowen. Steve Scala - Cowen & Co. LLC: Thank you. A couple questions. Regarding dropping the N3pG-plus BACE in Alzheimer's disease, the early data was great. So what was the reason for dropping the product? And it was mentioned that monotherapy continues. But I thought the monotherapy was discontinued earlier this year. Or has the monotherapy restarted? So that's the first question. Second question is on Jardiance. Why are you not filing for type 1 diabetes as an insulin adjunct in 2018, given the positive data? I think that had been the expectation that you would file this year. Thank you. Philip Johnson - Eli Lilly & Co.: Great, Steve. Thank you for the questions. Dan, if you'd like to answer where we are with the N3pG and BACE combo, and N3pG more broadly. And then, Enrique, if you'd like to take the type 1 filing question. Dan? Daniel M. Skovronsky - Eli Lilly & Co.: Yeah, thanks, Steve. Sorry for the confusion there. So on the N3pG BACE, we've dropped the BACE arm of this trial, so N3pG does continue. The decision to drop BACE was based on a couple factors. One was what we've seen across the field with various BACE inhibitors, where these drugs don't have a benefit. And they actually cause some increased rate of cognitive worsening. With our particular BACE inhibitor, we did see some increases in psychiatric adverse events that gave us some pause, as well as changes on imaging, increased rate of brain shrinkage. So that was the basis for the decision to discontinue BACE, despite as you said great preclinical data, showing a combination of BACE inhibition and N3pG to be beneficial in mice. N3pG, however, which is our plaque-clearing antibody, which really shows, I think, deep and rapid clearance of amyloid plaque from the brain, continues on in this Phase 2 study. This is designed to demonstrate evidence of efficacy. And we're really excited about that. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Dan. Enrique? Enrique A. Conterno - Eli Lilly & Co.: Yes. On Jardiance and type 1, clearly, as part of the EASE studies, we showed that Jardiance as an adjunct to insulin in patient with type 1 can have additional level of glycemic control. And we saw this across all doses that we basically studied. At this point in time, we are working with BI [Boehringer Ingelheim] on the regulatory next steps. And we hope to be able to share more shortly. Philip Johnson - Eli Lilly & Co.: Thank you, Enrique. Lola, next caller, please?

Operator

Operator

And at this time, there's no one in queue. Philip Johnson - Eli Lilly & Co.: Fantastic. Dave, then if you'd like to go ahead and conclude the call with some final remarks. David A. Ricks - Eli Lilly & Co.: Great. Thanks, Phil. Well, we appreciate your participation in today's earnings call and your interest in Eli Lilly & Company. Our strong execution through the first nine months of 2018 highlights the continued progress towards and the increasing confidence in the delivery of our revenue and profitability goals for 2020. We have seen continued pipeline progression, including our 10th new product launch since 2014; compellingly stage opportunities for tirzepatide, mirikizumab and pegilodecakin; and superiority of Trulicity in the ambitious REWIND CV outcome study. This progress underscores the opportunities for growth beyond 2020. We look forward to providing a more detailed update on our pipeline during our December 19 Investor Meeting. Thanks again for dialing in. Please follow up with our IR team if you have questions we have not addressed on the call. Hope everyone has a great day.

Operator

Operator

And, ladies and gentlemen, that does conclude your conference for today. Thank you for your participation and using AT&T Executive Teleconference. You may now disconnect.