Earnings Labs

Eli Lilly and Company (LLY)

Q4 2016 Earnings Call· Tue, Jan 31, 2017

$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

+0.74%

1 Week

+0.87%

1 Month

+8.76%

vs S&P

+3.98%

Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Q4 2016 earnings call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. I will now turn the conference over to your host, Dave Ricks. Please go ahead, sir. David A. Ricks - Eli Lilly & Co.: Thank you and good morning. Thanks for joining Eli Lilly & Company's fourth quarter 2016 earnings call. I'm Dave Ricks, Lilly's President and CEO. Joining me on today's call are Derica Rice, our Chief Financial Officer; Dr. Jan Lundberg, President of Lilly Research Labs; Enrique Conterno, President of Lilly Diabetes and Lilly U.S.; Dr. Sue Mahoney, President of Lilly Oncology; Chito Zulueta, President of International Business; Jeff Simmons, President of Elanco Animal Health; Dr. Tony Ware, who is the interim President of Lilly Bio-Medicines; and of course Kristina Wright, Chris Ogden, and Phil Johnson of the 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 with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It's not intended to be promotional and it's not sufficient for prescribing decisions. Before discussing key events for the quarter, I'll start with a summary of our progress since the Q3 earnings call using our strategic objectives framework. Starting with Grow Revenue, in Q4 we generated worldwide revenue growth of 7%, which was driven by 9% volume growth in our pharmaceutical business, led by her new products. Prices declined 1% in Q4. On our strategic objective Expand Margins, total operating…

Operator

Operator

Thank you. Okay, your first question is from the line of John Boris, SunTrust. Please go ahead.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Analyst · John Boris, SunTrust. Please go ahead

Thanks for taking the questions. So, Dave, a lot of fanfare this morning on CNBC regarding your meeting with Donald Trump. He obviously highlighted turning down regulation, improving the tax outlook, and also obviously a focus was on price. Does, after this meeting, President Trump understand the level of discount that's going on within DOD, VA, that Medicaid is getting products for free, Medicare Part D hasn't broken the budget? And what would happen under ACA if it goes away? The greater than $100 billion that the industry is contributing out of its SG&A line as a tax, would that go away? And then the second question, you did put out a release early on reorganization, obviously cut one head to streamline decision-making, but there seemed to be a greater emphasis on China, especially in light of you having run the operations there. Will you be changing any of your reporting going forward? Philip Johnson - Eli Lilly & Co.: Dave, those are for you. David A. Ricks - Eli Lilly & Co.: Sure, thank you, John. We had a good meeting with the President this morning. It was a broad-ranging discussion. We touched on several of the issues there. And your question in terms of innovation, the President was very interested in understanding how our business works and what the opportunities are to further grow the American innovative engine in the biopharmaceutical industry. Of course, we talked about taxes and how that could be a positive catalyst for more investment and growth in the U.S. industry. We talked about regulation. I think he made some comments on camera about that. He's interested in finding ways to reduce and streamline regulation, both at the FDA side but also in healthcare markets that the government plays a role in. And then…

Operator

Operator

Our next question is from the line of Mark Schoenebaum, Evercore. Please go ahead.

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum, Evercore. Please go ahead

Hey, guys. Thank you for taking the questions. And first, thanks to Phil and the whole organization for helping out my team while I was gone. I really appreciate that. I'd like to ask one business question and one science question I suppose. The business question is Sanofi's biosimilar Humira, can you just give us an idea of your expectations for market entry, timing of market entry, and what your plans are to mitigate that? I thought that would be helpful as that gets a little closer. And then number two, I noticed you said on the call that, I think if I heard you right, you're halting the prodromal trials on solanezumab. And that was interesting to me because I'd be curious. Given that you guys are one of the smarter Alzheimer's companies, I'd be curious to know what your current thoughts are on the A-beta hypothesis. Was the failure of solanezumab a failure of the molecule and/or was it a failure of the A-beta hypothesis to be – is A-beta behind Alzheimer's? And with the halting of the prodromal trial, I assume no longer – you don't believe it was simply the patient population enrolled. Therefore, that leaves molecule-specific issues and the hypothesis in general. I'd love to hear you talk on that. Thank you so much. Philip Johnson - Eli Lilly & Co.: Thanks for the question, Mark. Dave, if you'd like to, take the first one. And I did get some feedback that there might have been a little bit of echoing, so we'll mute here in the room as you provide your response. And then, Jan, if you'd like to lead off answering the second question, our view of the failure of solanezumab in the mild Alzheimer's population. And, Tony, feel free to complement his answer as well. Over to you, Dave. David A. Ricks - Eli Lilly & Co.: I think the question related to biosimilar – I think Mark said Humira from Sanofi, but I'm not aware of a biosimilar Humira program at Sanofi, correct?

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum, Evercore. Please go ahead

Humulin – Humalog. David A. Ricks - Eli Lilly & Co.: Humalog, yes, okay.

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum, Evercore. Please go ahead

Sorry, my bad. David A. Ricks - Eli Lilly & Co.: So maybe Enrique can handle that one. Enrique A. Conterno - Eli Lilly & Co.: So we of course are prepared for that event. We had in a certain way the fortune of launching a biosimilar glargine in Europe and now a follow-on insulin glargine in the U.S. So that's great preparation in itself because now we're going to be on the other side of that. And we are thinking how to best ensure that Humalog can continue to be an extremely strong franchise for Lilly. I won't discuss our specific plans, but I would say that we're very well prepared. Philip Johnson - Eli Lilly & Co.: Great. Thanks, Enrique. Jan? Jan M. Lundberg - Eli Lilly & Co.: The amyloid-beta hypothesis and the connection to Alzheimer's disease has strong evidence from genetics, where if you have too much amyloid in your brain, you get early Alzheimer's disease. And also the opposite, if you have less amyloid-beta production then by mutations in the APP in the BACE1 cleavage side, you also seem to be protected from dementia. The key question is so how do you translate then these genetics into realities of pharmacological treatment in an aged patient? And here there are a variety of approaches that have been used. And it's also a key one here to think about if you have an antibody with access to brain, 0.1% through the blood/brain barrier, how can you compare that result then to, for instance, an oral BACE inhibitor, which some of them go 100% into the brain and are I think more likely to have a marked effect than on the free amyloid beta? And the second question is clearly then how early do you have to treat? And I think we should recognize that even if you have mild Alzheimer's disease, your brain has been accumulating amyloids for decades, and you almost have maximum amyloid in your brain already. So I think there could be two components here, like I say. If solanezumab really entered the brain enough to affect amyloid beta, I think our biomarkers like amyloid PET didn't really change very much by solanezumab, nor did the actually tau then changes, which are more related to neurodegeneration change. So from that standpoint, we didn't see any objective measures I think that we changed the amyloid content in the brain, nor then neurodegeneration. Is this against or does this prove that the amyloid hypothesis is wrong? My view is it's too early to say. We need to wait for even more powerful agents. And the next in turn are the oral-based inhibitors, which are more likely I think to have an even stronger effect on the amyloid beta in the brain. And in addition then, we need to look at earlier stages of Alzheimer's.

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum, Evercore. Please go ahead

Thank you. Philip Johnson - Eli Lilly & Co.: Tony, anything to add? Anthony Ware - Eli Lilly & Co.: Yes, Mark, I think our view on the prodromal trial is that when we saw the results of EXPEDITION3 in patients with mild Alzheimer's disease, which of course were disappointing, when we looked at the prodromal, the patients in prodromal, these are not as distinct clinical divisions as you might think. There's a great deal of overlap between these two populations. And we felt within any given visit, a patient could be on one side of that or the other. So we felt as if that hypothesis had been tested, that those patients were close enough that the prodromal trial would be unlikely to be successful. As you point out and as per Jan's remarks, there are three differences, three potential variables here. There's the clinical stage we just talked about. There's the overall a-beta hypothesis itself, and then there are molecule-specific aspects as well. So those are the three sliders on the equation that we need to try to figure out.

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum, Evercore. Please go ahead

Thanks so much. Philip Johnson - Eli Lilly & Co.: Kevin, if we can, go to the next caller, please.

Operator

Operator

Next is from the line of Tony Butler, Guggenheim. Please go ahead.

Charles Butler - Guggenheim Securities LLC

Analyst · Tony Butler, Guggenheim. Please go ahead

Yes, thanks very much, a single question though for Derica, and it relates to gross margins, Derica. Certainly as the seven newer products that you call out have made an increasing contribution, as you noted, 12% in the quarter to overall revenue, one might expect gross margins to be able to move higher. I guess I'd love for you to comment on the pushes and pulls there, and more importantly, how you think about that as that contribution exceeds 12% certainly for the calendar year, even beyond 2017. Thanks very much. Derica W. Rice - Eli Lilly & Co.: Sure. The good news is there's no substitute for top line growth, and so having the 7% revenue growth or in the quarter the new products driving almost 9 percentage points of volume-driven growth is tremendous, and really the kudos go to the team in pulling that off. When you get to the gross margin percent, you did not see the improvement you may have been expecting. That's really driven more by mix. So in the quarter you did see, for example, on our insulin business, where you'll see as it gets more weight and we have negative pricing in that regime, that becomes a drag on our gross margin percent. And for now, insulin still is our largest product until the other new products catch up. So what you really saw in the quarter was more a mix effect.

Charles Butler - Guggenheim Securities LLC

Analyst · Tony Butler, Guggenheim. Please go ahead

Thank you, Derica. Philip Johnson - Eli Lilly & Co.: Kevin, if we can, go to the next caller, please.

Operator

Operator

Okay, our next question is from the line of Chris Schott, JPMorgan. Please go ahead.

Christopher Schott - JPMorgan Securities LLC

Analyst · Chris Schott, JPMorgan. Please go ahead

Great, thanks very much, just two questions here. Maybe first, can you talk about business development priorities? You recently announced an interesting but relatively small deal, but bigger picture, maybe a question for Dave. When you think about how Lilly has historically approached business development, should we think about a similar approach under your leadership, or are there any differences in how you're thinking about business development relative to your predecessor? Second question was coming back to Alzheimer's and BACE. How are you thinking about your BACE program and your molecule relative to Merck's program? Are there any important similarities or differences we should keep in mind as we consider potential read across from the Merck Phase 3 data later this year? Thanks so much. Philip Johnson - Eli Lilly & Co.: Questions, Dave, if you'll answer the question on BD priorities, feel free since you're obviously very well in this space to make an initial comment on the AstraZeneca BACE program we have, and the other BACEs that we're developing and relative to the Merck program, maybe, Jan or Tony, feel free to chime in as well. Dave? David A. Ricks - Eli Lilly & Co.: Sure. Thanks, Chris. In terms of business development, I don't see a change in our general approach, which is what we've said for a while, which is we see value in deploying capital on business development where we can really complement our core therapeutic areas, where we're looking at acquisitions or licensing transactions that can bring products into the portfolio to drive growth for the future and to do that with a lot of discipline on value. And so that's what I think we've been saying for years. I do think as we enter this phase coming up, where in our therapeutic areas…

Operator

Operator

Next is from the line of Andrew Baum, Citi. Please go ahead

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst · Andrew Baum, Citi. Please go ahead

Hi, a couple of questions, please. Would you care to characterize the magnitude of the financial impact from potential dual-eligible reform or alternatively provide us the delta in percentage terms between net prices for Medicare and Medicaid? And then second, you recently recruited Levi Garraway and Christi Shaw within R&D and SG&A respectively. Could you outline what their mandates are, particularly in relation to building your immuno-oncology franchise, which obviously is not where ideally you would like it? Many thanks. Philip Johnson - Eli Lilly & Co.: Andrew, thank you for the questions. Dave, would you like to take that second one first? And then you do you want us to answer here in the room the question on the dual-eligibles? David A. Ricks - Eli Lilly & Co.: Yes, that makes sense. Andrew, thanks for the question. We have brought in two senior executives recently. We're excited by both their willingness and excitement to join the company, but also what they can add probably in the very short term. Levi is joining Sue Mahony's team, really taking the role that Richard Gaynor had. So he's got all the clinical-phase oncology portfolio and obviously brings a great skill set to do that. I think in terms of immuno-oncology, he's got expertise in that field among other fields of oncology. And it's probably difficult to say too much about what we hope he'll do, but I think clearly it's a competitive field and having a new look at what we're doing, how we combine products, how we could potentially accelerate our efforts in certain areas is something that we're hoping Levi can help us with. Christi is a commercial person. She started her career at Lilly, most recently ran Novartis's U.S. business. And she's coming into the job I was in,…

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst · Andrew Baum, Citi. Please go ahead

Thank you. Philip Johnson - Eli Lilly & Co.: Kevin, if we can, go to the next caller, please.

Operator

Operator

Yes, and that's Gregg Gilbert, Deutsche Bank. Please go ahead.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Thanks. First for Enrique, in the past, Enrique, you flagged the concern about SGLT-2 new patient starts slowing. What are your latest thoughts on that subject now that you have a label and the updated guidelines? Perhaps you could give some color beyond just scripts. Then my second question is for Jeff. Can you give us some flavor around your outlook for the key parts of your business for 2017 and what some of the pros and cons were in the fourth quarter? Thanks. Philip Johnson - Eli Lilly & Co.: We'll go to Enrique, and then go to Jeff. Enrique A. Conterno - Eli Lilly & Co.: Sure, so we are clearly very excited about the new label for Jardiance in the U.S. and the new treatment guidelines for diabetes published by the ADA. We've launched now this new indication in early January. And we are thinking, I'll be honest, pretty big about the opportunity that we have in front of us given the indication that we have. Clearly for us to be successful, the class has to grow or more specifically Jardiance has to grow. And we think of that not just as we think about what is the Jardiance share in the SGLT-2 class, but what is the overall share that Jardiance could get when we think about people with Type 2 diabetes, and in particular in the segment where Jardiance is indicated for cardiovascular risk reduction, which is in people with Type 2 diabetes and established cardiovascular diseases. You can imagine that is as much as 30% of people with Type 2 diabetes, so very, very significant opportunity. It is too early to comment given that we have basically the first week of scripts, which is the first week that basically we launched the product. But I expect that we will see the uptick and we will see this in terms of new patient starts right away.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Thank you. Philip Johnson - Eli Lilly & Co.: Jeff? Jeffrey N. Simmons - Eli Lilly & Co.: Gregg, on the Animal Health business, as you know, in Q4 Elanco revenue increased 4%, so we saw the growth start to come back. This was driven by companion animal growth from new product launches primarily, and also I think some expanded partnerships and distributors around the globe as we continue to increase our footprint. Operating margins also I would state expanded to 24% in Q4. That's in comparison to 19% a year ago, so we continue to make progress on integrating our recent acquisitions, and we anticipate further improvement as we go into 2017. So as you look at our strategic agenda, I think a few key things in 2017, first the completion of the BI acquisition that's integrated. We're taking orders. The teams have all been trained. We'll see 6% growth come from that in 2017. As Dave mentioned, we launched Galliprant in the U.S. in coordination with Aratana. This will expand our portfolio in companion animal therapeutics. We'll continue to see our base business expand through innovation, even on the food animal side, as well as just execution in bringing the value of the capabilities that we've gotten from the acquisitions through. And some of the external factors we see moderating and stabilizing as you look at Latin America and dairy. So in summary, I would say our margin improvement will expand to that mid-20s, as we've mentioned, and look to see our growth will return to grow in our base business to the mid-single digits, mostly in the second half of the year, and then again have the BI acquisition growth come through as well. Philip Johnson - Eli Lilly & Co.: Great. Thank you, Jeff. Kevin, if we could, go to the next caller, please.

Operator

Operator

The next questioner is David Risinger, Morgan Stanley. Please go ahead. Your line is open, sir. David R. Risinger - Morgan Stanley & Co. LLC: Great, thanks. Sorry, I had you on mute there. I have two questions. First, Dave, if you could, comment on how the meeting with President Trump concluded and next steps we should expect from the administration. And then second, I was hoping a member of the team could comment on the abemaciclib Phase 3 readout timings ahead. Thank you. Philip Johnson - Eli Lilly & Co.: Great, Dave, thank you for the questions. So, Dave Ricks, if you'll answer the first part of Dave Risinger's question, then absolutely we have Sue Mahony here, who can address your second question, Dave. David A. Ricks - Eli Lilly & Co.: Thanks, Dave. As I said earlier, we had a positive and broad ranging discussion. And I was impressed with the President's appreciation for what our industry is, which is really a crown jewel of America enterprise in the sense that we invent things, we can change lives in terms of healthcare outcomes, but also we're a great employer and source of economic growth, jobs, and exports. We touched on lots of things, tax, regulation, as well as the healthcare repeal/replace discussion. So there's a number of follow-ups that were cited that will be happening through staff and on the Hill with key members of Congress. The specifics on timing and so forth I'm not at liberty to share here, but I was encouraged overall by the sense a) that there will be changes made, likely rapidly. Most of those will involve the legislative branch. And that there will be follow-up with the White House to make sure we're making progress as we go along. But there's not too many specifics I can share in terms of exact timing. Just overall, I think it was productive to engage the President, educational for both sides, and I think we can go forward and really look at enacting policies that can both help the industry but also healthcare in the United States. Philip Johnson - Eli Lilly & Co.: Great. Sue? Susan Mahony - Eli Lilly & Co.: So with regards to abemaciclib readouts, we're anticipating getting the MONARCH-2 data and having that read out this first half of year. With regards to – and that's the fulvestrant study. The MONARCH-3 Phase 3, we should have an interim the first half of this year. Our base plan, as we've said previously, is that we will continue through the final, which we could see the end of this year. Philip Johnson - Eli Lilly & Co.: Thank you, Sue. Kevin, if we could, go to the next caller, please?

Operator

Operator

Our next caller, Jami Rubin, Goldman Sachs. Please go ahead. Jami Rubin - Goldman Sachs & Co.: Thank you, a question for you, Dave. Do you see the opportunity to improve the company's operating margin goals? I think that if memory serves me right, three, four years ago you really set out a goal to achieve SG&A and R&D at 50% or lower. Again, that was set up three, four years ago, maybe even longer. I'm just wondering if you see opportunities to either update that goal you set for 2018 or where you see it going. And the reason I bring it up is yes, you had a real high-quality quarter this quarter, but you could have massively beat if expenses, came in line, even at the midpoint of your guidance. Both SG&A and R&D were at the very top of your guidance. And for the full year, your operating margins were 21.7%. I think that is the absolute bottom of the industry. So can you talk about with your – driven by your new pipeline, what the magnitude of potential improvement that you see for operating margins? Are there structural impediments such as mix effects that will keep margins below industry average? How should we think about it over the next three to five years? Thanks. Philip Johnson - Eli Lilly & Co.: Okay, thanks, Jami. Over to you, Dave. David A. Ricks - Eli Lilly & Co.: Sure. Thanks, Jami, great question and one we're spending a lot of time on as well. Of course right now, we're working against the prior goal you cited, which is to get our SG&A and R&D total operating expenses as a percent of sales to 50% or less in 2018. So that's the near-term goal we're very focused on. We've…

Operator

Operator

That's Tim Anderson, Bernstein. Please go ahead. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC: Thank you, a couple of questions. One is a higher-level payer question. Do you think that the relationship between drug companies and PBMs will come under more government scrutiny as it relates to rebates? And kind of a thought exercise, from your perspective, would it be good or bad for drug companies to have that whole rebate process potentially go away? Second question is on Alimta. You noted that that is the chemotherapy drug used in KEYNOTE-189. How does the trajectory of Alimta change from where it is today, if that trial is positive or if the Merck regimen gets early approval in May on the Phase 2 data they filed on? What does your 2017 guidance assume, and could there be upside in 2017 and also beyond 2017? Philip Johnson - Eli Lilly & Co.: Thank you for the questions. Dave, if you'd like to take the first question that we received on scrutiny of the relationship and the business relationships with PBMs and pharma companies. Then over to Sue on the question on Alimta in combination with Keytruda. David A. Ricks - Eli Lilly & Co.: Sure. Thanks, Tim. I think a lot was written about that question. To be honest, we have good relationships with all the major PBMs. Of course, it's a business transaction and we're on opposite sides of the table. They do their job very well. They negotiate hard for rebates and discounts for their customers, most of which are large commercial plans or Part D. And we do our job, which is to sell the value and try to maintain formulary position. There are always tugs and pulls in that and products are listed and delisted,…

Operator

Operator

And that's Steve Scala with Cowen. Please go ahead. Steve Scala - Cowen & Co. LLC: Thank you. I have two questions. Can you provide any perspective on the reasons for the delay in the baricitinib PDUFA? So that's the first question. And the second question is what should we conclude about Lilly's 2017 guidance in light of the fact that I believe Lilly has exceeded the top end of the initial EPS guidance range in each of the last six years? Thank you. Philip Johnson - Eli Lilly & Co.: All right. Steve, thank you for your questions. So we'll go to Tony Ware for the first question on the baricitinib NDA review here in the U.S., and then over to Derica for your second question on guidance. Tony? Anthony Ware - Eli Lilly & Co.: Thanks, Steve. In any regulatory review, the FDA submits various information requests, and then we respond to those as well as we can. The FDA makes a determination once it receives any of these information requests as to whether additional analyses that we have provided, and that's what they are is new analyses of the data that they already have, are sufficiently complicated so that it would extend the time that they would require to review the application. And that determination is made entirely by them, and we don't have much insight into the rationale for that. I want to point out that they did not ask us to do more studies, which is an important point. So that's about really all I can say definitively. I would point out, of course, that this application in the wide world of applications that we send to them, it would be on the more complex side. It's five Phase 3 studies. There are different endpoints,…

Operator

Operator

Next is Seamus Fernandez, Leerink. Please go ahead.

Seamus Fernandez - Leerink Partners LLC

Analyst

Great, thanks for the questions, so just a couple here. For Enrique, can you talk a little bit about the opportunity to continue to expand your margins within the diabetes business, particularly in the wake of or in the midst of the arms race pullback that you're seeing from competitors with regard to the field force? I think on your update conference call on the promotional efficiency of the business, you stated that no additional sales reps had been added despite the significant increase in the number of products in the portfolio. So just wondering if you see more opportunity as you continue to grow that business for additional leverage. The second question is more broadly for Dave and maybe to some degree Enrique, given your new role. Can you guys talk a little bit about the willingness to utilize your relationships with managed care, particularly in areas like IL-17 and with the Taltz portfolio? Is now the right time to start to work those relationships or accelerate them? And do you see similar opportunities for those types of interactions on the oncology side of the business? And then just one final question, Dave, can you just give us a general sense of how you're thinking about business development on a go-forward basis? Do you see it more as partnerships, or do you see it more as outright acquisitions? I ask that question more in the wake of the decision to walk away from the partnership with Adocia, which again certainly was a surprise to that company who was a partner. And we've seen some questions raised with regard to how the partnerships have been executed in the past. So it would be nice to know how you guys are thinking about the business development strategy going forward. Thanks. Philip Johnson - Eli Lilly & Co.: So I'm not sure we understood exactly, Seamus, the middle question you had about leveraging the relationships with payers on Taltz or oncology. Can you be a little more specific on what you're looking for there?

Seamus Fernandez - Leerink Partners LLC

Analyst

Just a willingness whether you'd be willing to go to exclusive formulary access or utilize more aggressive discounting despite what are areas of strong potential growth for the industry and for the company in order to participate in that growth earlier? Philip Johnson - Eli Lilly & Co.: Okay, thank you for that clarification. Enrique will lead off with the ability expand margins in diabetes. Dave, then if you'd like to comment on the second question on leveraging the relationship and how that might evolve with the payer group and your BD priorities, then we'll come back into the room so if there's anything you want to add to that middle question on the oncology front, please do so. Enrique? Enrique A. Conterno - Eli Lilly & Co.: Sure. So we are indeed seeing very significant opportunity to continue to leverage the income statement when it comes to diabetes. We have very strong sales growth, which is driven by volume. As we have mentioned in the past, we're getting some of the benefits from our technical agenda when it comes to diabetes on the manufacturing side. And as we've said, that is for us several percentage points worth of benefit that we're getting, and those benefits continue to accrue and gross margins continue to improve. And finally, when it comes to SG&A, we are basically able to with the commercial footprint that we have support the broad range of products, including all of the products that we have recently launched. So we do believe we have the right infrastructure to support continued growth without us having to add additional commercial infrastructure. When we look at the number of people out there, we are a little bit below some of our competitors when it comes to diabetes, even post some of…

Seamus Fernandez - Leerink Partners LLC

Analyst

Thank you. Philip Johnson - Eli Lilly & Co.: Comments on oncology? Susan Mahony - Eli Lilly & Co.: No, I would just say the same as what Dave said. We will compete based on the differentiation of the product. Clearly, what the data tells us will help us to better understand what levers we pull across the whole of the marketing mix. Philip Johnson - Eli Lilly & Co.: Thank you, Sue. Kevin, next caller, please.

Operator

Operator

Next is Marc Goodman, UBS. Please go ahead.

Marc Goodman - UBS Securities LLC

Analyst

Hi. First question is you had mentioned that there was $130 million adjustment, mostly Humalog. Can you tell us what was the actual number for Humalog, and what were the other products that were impacted? And then second, help us understand just the way that the revenues – I understand the partnership with BI, but Jardiance and Trajenta. And I'm just looking at the way that the U.S. numbers have progressed throughout the year, and they seem to be bouncing around. Just give us a sense here. In the fourth quarter versus the third quarter, was there anything unusual going on? Was there any stocking? Jardiance really ramped up a lot. You see Trajenta coming down a lot, probably much more than what trends would tell you on script trends. So maybe you can just help us understand some of the dynamics there. Thanks. Philip Johnson - Eli Lilly & Co.: Thank you for the questions, Marc. We'll go to Derica for your first question, and over to Enrique. Derica? Derica W. Rice - Eli Lilly & Co.: Hi, Marc. You're correct. We did have a $130 million gross net benefit in the fourth quarter. What we've said is that a good portion, a sizable portion of that is attributable to Humalog. But we have not provided the absolute numbers behind it or any of the other products affected. Philip Johnson - Eli Lilly & Co.: Enrique? Enrique A. Conterno - Eli Lilly & Co.: When it comes to Jardiance and Trajenta revenue in the U.S., we do see numbers in the diabetes category move a bit based on the estimates for rebates and discounts. This is not just an item for Lilly. It's an item for any company in the diabetes space given the sizable rebates that are paid to payers. In this particular case, it is Boehringer Ingelheim that basically does the contracting and the estimation. In the case of Jardiance, we saw a slight benefit in the fourth quarter. And in the case of Trajenta, we basically saw a negative impact in the fourth quarter, the negative impact probably closer in terms of Lilly revenue nearly probably $20 million. So we expect to see that volatility when it comes to the diabetes product. What we try to look at is really longer term what are some of the trends that we basically see from a volume perspective and also from a pricing perspective. Philip Johnson - Eli Lilly & Co.: Great, thank you. Kevin, if we can, go to the next caller.

Operator

Operator

Next is Geoff Meacham, Barclays. Please go ahead.

Geoffrey Christopher Meacham - Barclays Capital, Inc.

Analyst

Good afternoon, everyone. Thanks for the question, for Dave, another policy question. Was there any discussion today in your meeting with President Trump on the role of PBMs and the role they play in the pricing equation? Do you feel like this could be a bigger part of the drug pricing conversation going forward? And on then on the galcanezumab Phase 3, some data from your competitors, namely Amgen, when you look at that, what would you think is the line for a clinically meaningful benefit? And then finally, with the CoLucid deal, you'll have a range of products. What do you think in this space more broadly is still fertile ground for innovation? Thank you. Philip Johnson - Eli Lilly & Co.: Great, Geoff, thank you for the questions. Dave, obviously the first one we'll pass over to you, and feel free if you want to comment on either of the following two. And then both Tony probably and Jan maybe will add some color here in the room as well. Dave? David A. Ricks - Eli Lilly & Co.: Thanks, Geoff. In terms of PBM specifically, that wasn't a centerpiece of the discussion with the President. Of course, pharma has recently put out some work just to put some facts into the picture in terms of what the total drug spend is in the nation and how much of that is innovative, generic, or going into the channel, if you will. I think it's available on their website if you want to look at it. That was referenced in the meeting, and I think it always does surprise people that fully one-third of spending in the U.S. is not going to manufacturers but going to other entities. I think the President was interested in that. Mostly we discussed…

Operator

Operator

That's from Richard Purkiss, Piper Jaffray. Please go ahead.

Richard J. Purkiss - Piper Jaffray Ltd.

Analyst

Thanks for taking the question. Just given Trulicity's really strong performance, could Enrique and maybe Jan just run through thoughts on how they see the upcoming competition from Novo's semaglutide, also how they view its retinopathy data and just hopes for the REWIND study? Philip Johnson - Eli Lilly & Co.: Richard, thank you for the questions. Enrique, if you want to lead off and Jan can... Enrique A. Conterno - Eli Lilly & Co.: Sure. So we are very excited about the growth of Trulicity. We're having great sequential growth, both driven by the overall strength and the health of the GLP-1 class, but also because of the share growth with Trulicity. I was just reviewing our latest data, and Trulicity now nearly has a 32% new-to-brand share in the GLP-1 class as of last week. And so it's really, really outstanding performance by the team. Overall for us, continued class growth is probably the most important factor, and we're excited. Maybe I can provide some color because we recently started reaching additional prescribers as of late last year, basically in the last quarter. And we've seen significant continued adoption by new prescribers. So that basically speaks to continued growth as we look ahead for this product. We do look at the competitive environment and we do look at semaglutide as a potential competitor in the near future. And they do have good efficacy data in a number of trials, including a head-to-head against Trulicity. But they also have reported an increasing retinopathy that was significant as part of one of their trials. So we need to see at the end of the day what the full label will be. And we are of course very prepared, but we really like our chances. Philip Johnson - Eli Lilly & Co.: And then thoughts on the REWIND study and a readout? Enrique A. Conterno - Eli Lilly & Co.: REWIND, we recently had an interim readout. We were basically told that the study will continue as planned, which basically means that we're looking at 2019 for the readout of the cardiovascular outcomes data for that study. Philip Johnson - Eli Lilly & Co.: Thank you, Enrique. We're almost at the top of the hour, so, Dave, we'll turn it over to you to close out today's call. David A. Ricks - Eli Lilly & Co.: Thanks, Phil. We appreciate your participation in today's earnings call and your interest in Eli Lilly and Company. Driven by new product launches, Lilly is entering a new growth period. The combination of top line growth and margin expansion over the balance of the decade provides a compelling thesis for investors. I look forward to keeping you informed of our progress, and please follow up with our IR team if you have questions we've not been able to address on today's call. Have a great day.

Operator

Operator

Thank you, ladies and gentlemen. That does conclude your conference. Again, thank you for joining. You may now disconnect. Have a good day.