Earnings Labs

Eli Lilly and Company (LLY)

Q3 2017 Earnings Call· Tue, Oct 24, 2017

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Transcript

Executives

Management

David A. Ricks - Eli Lilly & Co. Derica W. Rice - Eli Lilly & Co. Philip Johnson - Eli Lilly & Co. Enrique A. Conterno - Eli Lilly & Co. Michael J. Harrington - Eli Lilly & Co. Christi Shaw - Eli Lilly & Co. Jeffrey N. Simmons - Eli Lilly & Co. Susan Mahony - Eli Lilly & Co. Jan M. Lundberg - Eli Lilly & Co. Joshua L. Smiley - Eli Lilly & Co.

Analysts

Management

Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC David R. Risinger - Morgan Stanley & Co. LLC Andrew S. Baum - Citigroup Global Markets Ltd. Jami Rubin - Goldman Sachs & Co. LLC Umer Raffat - Evercore Group LLC Tony Butler - Guggenheim Securities LLC Marc Goodman - UBS Securities LLC Seamus Fernandez - Leerink Partners LLC Chris Schott - JPMorgan Securities LLC John T. Boris - SunTrust Robinson Humphrey, Inc. Gregg Gilbert - Deutsche Bank Securities, Inc. Steve Scala - Cowen and Co. LLC Vamil K. Divan - Credit Suisse Securities (USA) LLC Geoffrey Meacham - Barclays Capital, Inc. Richard J. Purkiss - Piper Jaffray Ltd. Jeffrey Holford - Jefferies LLC Alex Arfaei - BMO Capital Markets (United States)

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Q3 2017 Earnings Conference Call. At this time, telephone lines are in a listen-only mode. Later, there will be an opportunity for questions and answers, with instructions given at that time. [Operation Instructions] And as a reminder, today's conference call is being recorded. I would now like to turn the conference call over to your first speaker, Dave Ricks. Please go ahead. David A. Ricks - Eli Lilly & Co.: Good morning. Thank you for joining us for Eli Lilly and Company's third quarter 2017 earnings call. I'm Dave Ricks, Lilly's Chairman and CEO. Joining me on the call today are Derica Rice, our Chief Financial Officer; Josh Smiley, currently our Treasurer and the CFO-elect; Dr. Jan Lundberg, President of Lilly Research Laboratories; Enrique Conterno, President of Lilly Diabetes and Lilly U.S.A.; Dr. Sue Mahony, President of Lilly Oncology; Christi Shaw, President of Lilly Bio-medicines; and Jeff Simmons, President of Elanco Animal Health. We're also joined by Kristina Wright, Chris Ogden, and Phil Johnson of the IR team. This will be the last earnings call for two senior executives that have been instrumental in our company's success. At the end of the year, Maria Crowe, President of Manufacturing Operations; and Derica Rice, our CFO, will retire. Maria has helped Lilly earn the trust of patients we serve by making medicines with the highest levels of quality and safety. Derica played a key role in leading Lilly through the challenging period of patent expirations we called years YZ, and emerging as a much stronger company. Both have built strong organizations that will carry on their work. So beginning here, please join me in a round of applause to thank both of them for their contributions to our company. During this…

Operator

Operator

Absolutely. First question will come from the line of Tim Anderson with Bernstein. Go ahead, please. One moment. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Thank you. On Trulicity, an important growth driver, you guys called it out a major future growth driver. I'm wondering if you can just give us your thoughts on the curve of that product as we go into 2018 because you are facing new branded competition from Novo's weekly product. I think they had some compelling head-to-head data. I'm wondering how you think that might impact your product. And equally, importantly, they have their oral GLP-1, I think it was in several Phase 3 readouts coming in 2018, and I'm wondering if you can give us your opinion of the viability of that program. It seems that if they had a good clinical profile, that could be problematic for injectable GLP-1s. Reducing the clinical profile of that product will, in fact, be problematic. And then on Humalog, no biosimilar yet approved. You guys have I think a patent that you could potentially exert and leverage into a delay or maybe a settlement with Sanofi. Can you give us any update there? Philip Johnson - Eli Lilly & Co.: Great. Tim, thank you for the question. So Enrique will go to you for the questions on Trulicity heading into 2018 with new branded competition coming and thoughts on the oral GLP-1 space. And then we do have our General Counsel, Mike Harrington, with us. So, Mike, if you'd like to give the update on litigation with Sanofi. Enrique? Enrique A. Conterno - Eli Lilly & Co.: Well, thank you for the question. And indeed, Trulicity is having a terrific year. It's a unique time when it comes to innovation in diabetes. Let me…

Operator

Operator

Sure. That'll be from Dave Risinger with Morgan Stanley. Go ahead, please. Mr. Risinger, your line is open. David R. Risinger - Morgan Stanley & Co. LLC: Sorry. My apologies. I had it on mute. So thanks very much for taking my questions. My first question is with respect to the animal health business. So you've announced that you're exploring strategic alternatives. Could you just provide a little bit more color on the timing? Why now? I know that this is something you've contemplated for years, but the business' organic growth hasn't been inspiring recently. And so it'd be helpful for you to just provide a little bit more color about why now and how you see the business' organic growth prospects going forward. And then second, with respect to Forteo, I believe there may potentially be generic entry in the U.S. and Europe in 2019, but it would be helpful to get your perspective on how investors should think about the generic threat to Forteo in 2019. Thank you. Philip Johnson - Eli Lilly & Co.: Dave, thank you for the questions. So Dave Ricks, if we can have you answer the question on alternatives that are being explored and timing for the Elanco Animal Health review. And then Christi, if you want to comment on the outlook for Forteo post generic entry? David A. Ricks - Eli Lilly & Co.: Great. Thanks, Dave. We haven't touched on the short-term operational things, and we may get other calls on that. I mean, it is true. We've had some challenges in the business this year. We don't look at the question of how we should position Elanco in the short-term; we think of it as long-term. And we've been, as you point out, asked this question for a long time;…

Operator

Operator

Sure. That will come from the line of Andrew Baum with Citi. Go ahead, please.

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Thanks. A couple of questions. I'm surprised you haven't (26:45) ... Philip Johnson - Eli Lilly & Co.: Andrew, it's very low volume and it's cutting in and out a little bit.

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Sorry about that. Is that any better? Philip Johnson - Eli Lilly & Co.: Yes, thank you.

Andrew S. Baum - Citigroup Global Markets Ltd.

Management

Terrific. So I was saying I'm surprised that I haven't seen Lilly use their balance sheet for any more substantial business development within oncology given the reshaping of the business. Could you just maybe share a little bit of color. Is that a question of the bid-ask spread? Is it available assets? Is it a clinical base that needs to be turned over? What is potentially delaying that? And the second, the relative performance of Taltz versus your competitor, Cosentyx, especially in the last quarter would seem to disfavor Lilly. Could you outline what are the in-market dynamics that are driving this disproportionate marketing and how you're thinking about adjusting going forwards? Philip Johnson - Eli Lilly & Co.: Great. Andrew, thank you for the questions. Derica, if you'll address the question on using our balance sheet for business development and oncology, and then the impediments we're seeing to actioning that. And then Christi to comment on dynamics with Taltz and Cosentyx in that market. Derica? Derica W. Rice - Eli Lilly & Co.: Sure. Hi, Andrew. Good morning. We have no apprehension or reservations about using our balance sheet to pursue our therapeutic goals, whether it's in oncology or across our other therapeutic segments in which we compete. And we do continuously look at the marketplace for external asset opportunities that we'd like to pursue. Most recently, you've seen just this year, three years, three deals in the area of oncology. Now, all of those are early-stage deals, and that's by design. That's the area that we've chosen to focus on. If we can find late-stage assets like we did with CoLucid at the beginning of this year, we'll pursue that as well. In regards to market prices, oncology is still a very expensive real estate, and one of…

Operator

Operator

That will be from Jami Rubin with Goldman Sachs. Go ahead, please. Jami Rubin - Goldman Sachs & Co. LLC: Thank you. Just a couple of follow-up questions. First on DowElanco. Can you remind us, Dave, what the operating margin is on that business? I seem to recall that's a lower-margin business than your base business, but your overall operating margins, at around 22% or so, are well below the industry average. So if you contemplate spinning that business or selling that business, can you talk sort of generally about what impact you would see that having on your overall margins? And then secondly, just given the opportunity to take advantage of the risk of the P/E overcharge given where Zoetis is trading, what do you think you will do with those proceeds? And just if I can ask a question about the cost-cutting announcement that you made a couple of months ago, the 3,500 physicians that you are reducing. That has generated some debate among investors regarding your confidence and your ability to hit your sort of mid-single-digit top line growth projection over the intermediate term. Can you shed a little bit of light on the reason for the additional cost-cutting program? I know that should lead to an improvement in operating margins. But should we think of this as an insurance policy against the top line growth opportunity or should we look at this as above and beyond how the company expects to perform going forward? Thanks very much. Philip Johnson - Eli Lilly & Co.: Okay. Jami, thank you for the question. If I can, I'm going to reorder our answers just to sort of get the flow going here. So Dave, if you wouldn't mind handling the head count reduction question, the last one Jami had…

Operator

Operator

Yes, sir. That will come from the line of Umer Raffat with Evercore. Please go ahead.

Umer Raffat - Evercore Group LLC

Management

Hi, guys. Thank you so much for taking my questions. I wanted to focus on a couple of things. One, on baricitinib perhaps. Just curious what your confidence is on the 4-milligram dose in particular. And then secondly, just touching up again on lispro. Can you confirm – and I heard the prior comments – but can you confirm that there's no settlement at present between you and Sanofi on the lispro launch? And then also, how do you think about lispro launch? And in theory, how should or shouldn't it be different than Basaglar versus Lantus? Thank you. Philip Johnson - Eli Lilly & Co.: Great. Umer, thank you for the question. I assume with the 4-milligram, you're referring to the ongoing review at the FDA for our rheumatoid arthritis application. Is that correct?

Umer Raffat - Evercore Group LLC

Management

Correct. Philip Johnson - Eli Lilly & Co.: Okay. So Christi, we'll go to you for the question on baricitinib 4-milligram. Mike Harrington, if you'd like to comment on whether or not there's any kind of settlement with Sanofi. And then Enrique for the dynamics that you could might think about for the launch of lispro, whenever that occurs here in the future. Christi? Christi Shaw - Eli Lilly & Co.: So I think it's important as we discuss the 4 milligrams of baricitinib to see, well, how is it doing, where we are commercializing the 4 milligrams. As we look at Europe, for example, specifically in Germany, the launch in Germany not only exceeds our internal expectations. But as you look at the five months in which it's been available, it has exceeded every rheumatoid arthritis launch in history, including Humira. So as we look at that uptake in the 4 milligrams is the majority of the use. And we see what the patients are seeing in coming back to their offices where they were debilitated. They've tried other agents and they've gone on baricitinib and, really, things like in Japan are now able to drive where they haven't been able to before. It's really life-changing. So as we look at the U.S. and our discussions with FDA and the ongoing conversations we continue to have, the 4 milligrams is imperative for these patients to get the benefit and the efficacy that they need to be able to go about their daily life. So it is still our strategy that we believe in the 4 milligrams. We're seeing it play out in the real world and we look forward to having the resubmission, and it is on track to happen before the end of January as we had mentioned…

Operator

Operator

That will be Tony Butler with Guggenheim Securities. Go ahead, please.

Tony Butler - Guggenheim Securities LLC

Management

Yes. Good morning. Enrique, back to Trulicity, if I may. To what degree is the growth due to switches from Victoza versus that from orals straight to Trulicity? Part B of this is does or would diabetic retinopathy actually cloud the class assuming that's part of the warning of semaglutide in the label? And then the second question is really around abemaciclib in non-small cell lung cancer. Well one trial did not show OS, and I'm curious your confidence on the other trials specifically in non-small cell lung cancer. Thanks very much. Philip Johnson - Eli Lilly & Co.: Great. Tony, thank you for the question. So Enrique, the first two for you on the source of Trulicity growth as well as if the diabetic retinopathy that was seen in one of the Novo studies might impact the overall class. And then Sue, over to you for a discussion on the other trials that are ongoing for abemaciclib in non-small cell lung cancer. Enrique? Enrique A. Conterno - Eli Lilly & Co.: Very good. When it comes to the source of Trulicity growth, I think it's important to highlight that our strategy from the very beginning was not to focus on current GLP-1 users. So most of our strategy has been on additional adoption by specialists and then, really, the breadth in primary care. I believe the strategy has been highly successful, so the source of our business by a very significant amount. I don't have the actual figures with me but it's minimal whatever we get in terms of switching from other GLP-1s. We'd like for that to continue given the opportunity when it comes to patients on oral medicines that could benefit from better control. When it comes to retinopathy, the data for Trulicity I think is very…

Tony Butler - Guggenheim Securities LLC

Management

Thanks very much. Philip Johnson - Eli Lilly & Co.: You're very welcome. Alan, if we can go to the next caller?

Operator

Operator

That will be Marc Goodman with UBS. Go ahead.

Marc Goodman - UBS Securities LLC

Management

Yes, morning. If we look in the Phase 2 pipeline there, there's eight products. I think many of us know the base but several of the others are not as well-known. Can you just talk about some of the products and where we should be focused and what kind of data we should be expecting and where there's excitement there? And then just secondly on Basaglar. It had a very strong uptick relative to the script trend, so I was just wondering if there was any stocking or anything unusual in inventory change there. Thanks. Philip Johnson - Eli Lilly & Co.: Great. Marc, thanks for the question. So Jan, if you'd like to take the lead on the Phase 2 pipeline question. Others, feel free to augment that answer if you'd like. And then Enrique, anything unusual on the quarter on the Basaglar numbers, so if you can comment on that. Jan? Jan M. Lundberg - Eli Lilly & Co.: Okay. So let me start in immunology with mirikizumab, our IL-23 P19 antibody, which is tested in psoriasis as well as the two IBD indications, ulcerative colitis and Crohn's. And we are expecting data, well, early next year. The first half for particularly psoriasis will come first. In immunology, we also have the oral BTK inhibitor, the Bruton tyrosine kinase, which we are testing in RA, with also data coming next year and we are interested clearly because it's another potential oral agent in the immunology space. For diabetes, we have two agents. The first one is GIP/GLP-1. It's a dual agonist then of two different mechanists to lower body weight and also having potentially a better glucose control. We are particularly interested in this agent since in pre-clinical models it had actually better efficacy than any other GLP-1…

Operator

Operator

Yes, sir. That'll be from Seamus Fernandez with Leerink Partners. Go ahead, please.

Seamus Fernandez - Leerink Partners LLC

Management

Hello. Thanks for the question. So just a couple here. You guys have obviously evaluated the Elanco potential spin for quite some time. Dave, if you want to talk a little bit and just kind of get your sense of – in the current market we've seen companies make these types of announcements and then it takes a longer period of time to actually execute on the spin and then the results and disappointment. Just trying to get a sense of your commitments to offering a definitive conclusion as of the middle of 2018, as you stated in your press release. And if we could, just to get a sense, I think the spin is fairly obvious. But historically, most companies have talked about the synergies between the business. Dave, I was just hoping you could talk about if you see those synergies in the business any longer given the evolution of Lilly's business. And then my second question, we did see a few additional VTEs announced for a competitor JAK inhibitor in an ACR abstract. I wanted to know if there has been any change in the frequency or rate of VTE that you've seen in any of your clinical data or if it's still consistent, as part of the resubmission, if it's consistent with the rates that we've seen in the past which I believe you've stated are consistent with the historical rates of VTE for patients with RA. Thanks. Philip Johnson - Eli Lilly & Co.: Okay. Seamus, thank you for the question. So Dave, we'll go to you for the first couple of questions on we'll be able to provide a definitive answer by mid-2018 on the strategy for Elanco going forward and your view on synergies with that business. And then over to Christi to…

Operator

Operator

That will be the line of Chris Schott with JPMorgan. Go ahead, please.

Chris Schott - JPMorgan Securities LLC

Management

Great. Thanks very much. Just a couple of questions here. Maybe first on Jardiance dynamics. You're obviously seeing very healthy share gains. But when you're thinking about overall category growth, are you happy with the trends we're seeing there, and what do you think is going to take to further expand usage of the class overall? My second question was a broader diabetes question. I know each segment is different but just as we've gotten maybe further into contracting season, et cetera, just any preliminary comments about 2018 in either pricing or access to the portfolio. Anything we should just be keeping in mind as we think out to next year? And then my follow-up question was on Elanco as we think about strategic options. Do you believe further consolidation among large animal health players is possible from an anti-trust perspective, as we think about the various kind of options that you're considering with this strategic review? Thank you. Philip Johnson - Eli Lilly & Co.: Chris, thank you for the questions. Enrique, the first couple for you on Jardiance, in particular class growth and potential catalysts with that going forward. And then the diabetes 2018 access picture, to the extent that you can comment. And Dave, if you can talk through the question on the Elanco consolidation and the animal health industry question. Enrique? Enrique A. Conterno - Eli Lilly & Co.: So Jardiance has pretty quickly become the new standard when it comes to initiating patients on an SGLT2 therapy. Our share now when it comes to new to brand prescriptions is now north of 50%, and the overall trends when it comes to volume or share I think are very strong. Of course, when we look at the class, we do see some dynamics related to the…

Operator

Operator

That will be John Boris with SunTrust. Go ahead, please.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Management

Thanks for taking the questions. First question just has to do with abemaciclib. Listening to the Novartis call this morning, it certainly seems as though the launch of Kisqali has certainly underwhelmed Novartis. What have you learned from the Pfizer and both the Novartis launches relative to the profile of abemaciclib as we track this product going forward here that gives you confidence that it'll have some relatively robust uptake? And then second question, just has to do with pricing in particular. Questions we get all the time are the difference between gross to net and the FDA's approval of so many innovative agents in therapeutic categories that, over time, is going to lead to an increase in the gross to net differential as discounting and rebating plays a much greater role. Dave, how do you think about the business especially your most profitable affiliate, the U.S., in managing that going forward to add some comfort to investors who take a long-term view and invest for the long-term? And then on the patient front, obviously a lot of discounts and rebates certainly aren't passed onto customers as their deductibles and their co-pays are going up. What's a potential solution? Is there one out there to potentially ensure that a greater amount of that discount and rebate gets back into the customers' pocket so they can afford the new innovative medicines that you have here going forward? Thanks. Philip Johnson - Eli Lilly & Co.: Great. Thank you for the questions, John. So Sue, we'll go to you for things we've learned from the Ibrance and Kisqali launch as we think about launching Verzenio. And then Dave, the questions on managing the U. S. market, particularly the dynamics who'll be brought by more branded agents being approved and causing competition as…

Operator

Operator

Yes, sir. That will be Gregg Gilbert with Deutsche Bank. Go ahead, please.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Management

With respect of animal health, Jeff, perhaps you can comment with more granularity on some of the revenue pressures you're seeing and are they Elanco issues or industry issues. And where is your atopic dermatitis pipeline given the success of Apoquel (01:09:23)? Interested to know when you could show up in that market. And then for Enrique, a higher-level question beyond the sort of tit for tat on individual diabetes compounds. In the past, when we've met, you've suggested that there could be more of a push to partner with technology companies to enhance your overall diabetes franchise and solutions-based approach. So what can you say about that strategy at this point? Thanks. Philip Johnson - Eli Lilly & Co.: Gregg, thank you for the question. So, Jeff, commentary on the revenue pressures, what's Elanco versus industry in terms of dynamics, and a little bit of the pipeline and outlook for getting into the atopic dermatitis companion animal space. And then Enrique, a question over to you on our strategy for working with devices and device companies going forward. Jeff? Jeffrey N. Simmons - Eli Lilly & Co.: Yeah. Greg, real quick, like, on animal health. I think I would just come back on Elanco just kind of to anchor back. We, again, grew 4% excluding FX. We did see strong growth in global poultry, and I think that overall sector is growing well. We grew 17%. And then, of course, the U.S. companion animal vaccine. The pressures really remain and I'll kind of separate them. One is all-around market access which is driven by the clean food kind of movement with antibiotics and productivity products. I think this is an industry issue depending on the product mix. And then I think competitive pressures that are coming from a combination,…

Operator

Operator

Yes, sir. That will be Steve Scala from Cowen. Please go ahead.

Steve Scala - Cowen and Co. LLC

Management

Thank you very much. On baricitinib, I have a follow-up to Seamus' question. So you stated that DVTs are in line with the expected background rate. Would you confirm that there has been no new imbalances even if they still remain within the expected background rate? And then on the second quarter call, Dr. Mahony said that KEYNOTE-189 top line release was not expected until late this year or early next. That was a surprising statement at that time given the September primary completion, but it has turned out to be correct. So I'm wondering if Dr. Mahony has any additional updates on the KEYNOTE-189 timing? Thank you. Philip Johnson - Eli Lilly & Co.: Great. Steve, thank you for the questions. Christi, a question on DVTs, any new imbalances. And then Sue, any update on the KEYNOTE-189 readout timing. Christi? Christi Shaw - Eli Lilly & Co.: Yeah. I can confirm there are no new imbalances in regards to DVTs. Philip Johnson - Eli Lilly & Co.: Great. And, Sue? Susan Mahony - Eli Lilly & Co.: And Steve, mine will be a quick answer, too. I don't have any update. I think you need to go to ESMO for any update on 189. Philip Johnson - Eli Lilly & Co.: Okay. Great. Thank you. Alan, if we can go to the next caller?

Operator

Operator

That will be Vamil Divan from Credit Suisse. Go ahead. Vamil K. Divan - Credit Suisse Securities (USA) LLC: Hi. Great. Thanks for taking the question. So one, I just want ask a question about the guidance, the more midterm guidance, and you mentioned the 5%-plus sales CAGR. And as we look at the models, I think our numbers and also consensus in general is a little bit less than that. So as you review the models, are there certain products that you'd highlight where you think the extra sort of $400 million or so in revenues may come by 2020 to get to that 5% number, and are there any expectations for business development that's built into that number? And then related to that, when do you think you're maybe comfortable giving us more guidance on 2020 in terms of OpEx or margins or maybe EPS growth or something along those lines? Thanks. Philip Johnson - Eli Lilly & Co.: Great. Vamil, thank you for the questions. Josh, we're going to road test you here. So if you like to comment a little bit if are there any BD transactions or placeholders built into that midterm guidance and any kind of qualitative comments you can give around where the Street may be missing something and/or confidence in those numbers, and then when we might give more details on 2020 or further out years in terms of midterm guidance. Joshua L. Smiley - Eli Lilly & Co.: Sure. Thanks. First on the business development piece. We don't have future business development sales built into our projections around the 5%. As you know, we're very active in looking at external innovation and opportunities. So if we see those, those would obviously help or add to our projections. I think as it…

Operator

Operator

Yes, sir. That will be from the line of Geoff Meacham with Barclays. Go ahead.

Geoffrey Meacham - Barclays Capital, Inc.

Management

Good morning, guys. Thanks for the question. Just a couple of quick ones. On baricitinib, on the back of the recent data in atopic dermatitis, maybe just help us with the size and scope of the Phase 3 program that you're starting later this year and what you guys see as the biggest product differentiator. And on the RA side for bari, should we expect any formal updates at medical meetings coming up, just broader safety question? And then a last one on Alimta. I know overall demand trends have, in fact, negatively impacted bio but what are you guys seeing with respect to first-line lung trends just of late? Thank you. Philip Johnson - Eli Lilly & Co.: Great. Geoff, thanks for the question. So Christi, the first two to you. Sort of the size and scope of the Phase 3 program and potential areas for differentiation. Any updates to the RA safety database coming at medical meetings. And then Sue, over to you for the trends in first-line non-squamous non-small cell lung cancer for Alimta. Christi? Christi Shaw - Eli Lilly & Co.: So on the atopic dermatitis front, I think just to clarify, we've got a lot of questions on our Phase 2 data which I think is relevant for the question on what our Phase 3 study design looks like. So in our Phase 2 data readout, we were very pleased with the results. Unlike our competitors, one of the things that we looked at is what is the depth of efficacy that we could achieve. And what I mean by that is we actually took the very resistant patient to corticosteroids. So we took patients, for four weeks they were on a moderate dose of topical steroids, and those patients that responded were actually taken out of pre-randomization. So only those patients that were not responding to topical steroids were actually randomized to Phase 3. And so you had, first of all, resistant patients to steroids. But second of all, you had patients that had less disease severity, so the easy scores at baseline were around 20. Where you see our competitors who did the opposite used a washout period of four weeks where patients will have an increase disease activity, their easy scores actually started at 30 and 32. So being able to show the results that we did in that patient population really gives us a lot of confidence as we move to the Phase 3 studies, and we will study Phase 3 similar to what our competitors did now that we know the depth of the efficacy. So as we look at monotherapy, we look at various doses of the 1, 2 and 4 milligrams. We'll be looking at different dosing, lower and higher. We are very confident that we'll have a robust study with robust results.

Geoffrey Meacham - Barclays Capital, Inc.

Management

And in terms of any updates from the RA program, safety updates coming at medical meetings, are there any – my understanding was that basically we may have some repeats of things that were done earlier this year but not necessarily new data? Christi Shaw - Eli Lilly & Co.: Correct. So we have a press release that will be coming out soon. We have 33 different scientific releases on both baricitinib and Taltz at ACR. And baricitinib will be new analysis that we've seen on safety but no new surprises in a negative way. And we look forward to showing you those, and links to those will be within the press release. Philip Johnson - Eli Lilly & Co.: Great. Thanks, Christi. Sue? Susan Mahony - Eli Lilly & Co.: Yeah. Geoff, with regards to Alimta. As you mentioned, we have been challenged by IO of taking the frontline setting over the past few months and we've been seeing a sort of steady decline. We are pleased to see that we have seen a flattening in the frontline share. We now have a 26% share of market in frontline. We've also seen an increase in the second line share as IOs move to frontline. And interestingly, as we're looking at the new to brand, we're seeing an increase in the uptake of Alimta with Keytruda in the frontline setting. Philip Johnson - Eli Lilly & Co.: Thank you for the update, Sue. Alan, next caller, please?

Operator

Operator

It will be Richard Purkiss with Piper Jaffray. Go ahead, please.

Richard J. Purkiss - Piper Jaffray Ltd.

Management

Yeah. Thanks. I have three questions for Enrique. Two quick ones. What proportion of patients initiating GLP-1 therapy in the U.S. now have some evidence of diabetic retinopathy? And then on average, in the U.S., how frequently are type 2 diabetic patients' retinas visualized? Philip Johnson - Eli Lilly & Co.: Great. Enrique, I won't try to repeat. I think you heard those clearly. So we'll go to you for the... Enrique A. Conterno - Eli Lilly & Co.: Not the second part. Philip Johnson - Eli Lilly & Co.: So the first one was the percent initiating GLP-1 that have evidence of retinopathy. And the then the second one is that the percent of patients, diabetics in the U.S., that are actually being scanned currently to look for advanced retinopathy. Enrique A. Conterno - Eli Lilly & Co.: So excellent questions. Unfortunately, on the last question, not enough. There's really a nominal number of patients with diabetes that actually do get screening. When we look at a patient with diabetes, I don't have the specific numbers for GLP-1. But when we look generally for patients with diabetes, they're about 30% of patients with diabetes have some degree of retinopathy. If you were to look at the more serious retinopathy, which is vision threatening, we are looking probably at a number of 3% to 5%. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Enrique. Alan, next caller, please?

Operator

Operator

Yes, sir. That will be from the line of Jeff Holford with Jefferies. Go ahead, please.

Jeffrey Holford - Jefferies LLC

Management

Hi. Thanks very much for taking the questions. I just want to dig a bit more into the JAK and bari safety. So can you just help us understand a bit better what the additional data and exposure data that you have will achieve do you think in light of the questions the FDA have around your original submission because I think, as you referred to before, there was a cluster of events there on just how additional exposure data potentially changes that. Secondly, can you just tell us exactly what is the background rate data that you referred to in terms of what you think should be there in this population? Obviously, some of these clinical trial populations have different levels of cardiovascular risks, and I don't know if you've really talked to whether your view was that some of the trials you've had have a particularly high or relatively low cardiovascular risk. And then is there anything that you're doing differently in your Phase 3 atopic dermatitis trial in terms of crossover, length of exposure? Just other things to help address this question a bit more robustly going forwards. Thank you. Philip Johnson - Eli Lilly & Co.: Right. Christi, all those are for you. So additional safety data... Christi Shaw - Eli Lilly & Co.: Well maybe I'll resign. Philip Johnson - Eli Lilly & Co.: What we think it's going to achieve, what is that background rate that we're referring to in this population and what population is that. And then if there's anything we're doing with the atopic dermatitis studies in Phase 3 that could help shed light on this particular safety issue as well? Christi Shaw - Eli Lilly & Co.: So in terms of what the additional data will help us with, let…

Jeffrey Holford - Jefferies LLC

Management

It's very helpful. Thank you. Philip Johnson - Eli Lilly & Co.: You're very welcome. We have time for one more question, Alan.

Operator

Operator

That will be from the line of Alex Arfaei from BMO Capital Markets.

Alex Arfaei - BMO Capital Markets

United States

Okay. Good morning, folks. Thank you for taking the questions. Two questions, please, and a clarification. First, why did you discontinue the N3pG antibody in Alzheimer's? If I recall correctly at your Alzheimer's R&D day, this was highlighted particularly given that it is similar to aducanumab. So what's the incremental in you there that led to discontinuation? Second, on Elanco. Unless I'm not mistaken, it's not growing organically, excluding the BI vaccine acquisitions. So does it have enough of a pipeline and R&D productivity to sustain growth in line with the market? And then finally to clarifying Humalog. Did I hear you correctly that there are no legal barriers from your side preventing Sanofi from launching their biosimilars? Thank you. Philip Johnson - Eli Lilly & Co.: Thank you for the questions, Alex. So Jan, if you'll answer the question on the discontinuation of the N3pG asset in the pipeline. Maybe Jeff and/or Dave, if you want to comment on sort of what are the growth drivers going forward and pipeline prospects for Elanco. And then Mike, if you want to clarify on the Humalog legal situation. Jan? Jan M. Lundberg - Eli Lilly & Co.: Yeah. If we start with the FLAG-specific antibody, N3pG, as you can see on the pipeline chart we actually have three molecules for that target, and the frontrunner molecule is still then inside the pipeline as active. And the follow-on molecule did not meet the clinical criteria that we wanted, so hence we stopped it. Philip Johnson - Eli Lilly & Co.: Just to be fair, we took a two to get one strategy in Phase 1 here. So I wouldn't over-read (01:29:09) the plan all along. And then Jeff, on the strength of the animal health pipeline? Jeffrey N. Simmons - Eli Lilly…

Operator

Operator

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