Eli Lilly and Company (LLY) Q4 2011 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 earnings call. [Operator Instructions] And as a reminder, today's conference call is being recorded. I would now like to turn the conference over to Ronika Pletcher, Director of Investor Relations. Please go ahead.

Good morning. Thank you for taking the time to join us for Eli Lilly & Co.'s Fourth Quarter 2011 Earnings Conference Call. I'm Ronika Pletcher, Director of Investor Relations. Joining me are our Chairman and CEO, John Lechleiter; our Chief Financial Officer, Derica Rice; our President of Lilly Research Laboratories, Dr. Jan Lundberg; our President of Elanco Animal Health, Jeff Simmons; and Ilissa Rassner and Phil Johnson from Investor Relations. During this conference 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 form 10-K and 10-Q filed with the Securities and Exchange Commission. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions. Since our last earnings call, we've had a number of significant events. Here are some of the highlights. In regulatory news, the European Commission approved the use of Alimta as continuation maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer after initial treatment with Alimta plus cisplatin. In the U.S., we submitted an sNDA to the FDA for the same indication. The FDA approved the use of ERBITUX in combination with chemotherapy as a first-line treatment for recurrent, locoregional or metastatic squamous cell carcinoma of the head and neck. The FDA approved Jentadueto, the linagliptin plus metformin fixed-dose combination for the treatment of adults with type 2 diabetes. The FDA also approved Amylin's BYDUREON as adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. We submitted Amyvid for regulatory review in Europe for the detection of beta-amyloid plaque in the…

Thanks, Ronika. As you can see on Slide 10, the revenue decline of 2% for the quarter was driven by a negative impact of 11% from price, partially offset by a favorable impact of 8% from volume. Foreign exchange had a negligible impact on worldwide revenue. You'll see that we experienced a material U.S. price decline and a U.S. volume increase. Both U.S. price and volumes reflect the Zyprexa patent expiration and our post-patent strategies. Despite a decline in sales volume for branded Zyprexa, U.S. volume increased in the fourth quarter of 2011 as a result of the timing of sales of authorized olanzapine to Prasco. This volume increase was more than offset by significant price reductions attributable both to authorized olanzapine and branded Zyprexa. Moving to the next row of numbers, you'll see that both price and volume declined in Europe. Again, this was due to the Zyprexa patent expiration. We continue to see strong volume growth from our 3 countercyclical growth areas: Japan, Emerging Markets and Animal Health. You can see that in Q4, volume growth in Japan was 19%. Emerging Markets, which is embedded in the ROW line, experienced 16% volume growth. Finally, Animal Health delivered 10% volume growth. For the full year, total revenue growth of 5% was driven by growth of 6% from volume and 2% from FX, partially offset by a 3% decline in price. Volume growth was notable in Japan at 21%, in Emerging Markets at 12% and in Animal Health at 18%. Notably, Trifexis, our oral treatment for dogs to prevent and treat flea infestations, prevent heartworm disease and treat and control adult hookworm, roundworm and whipworm infections, achieved Animal Health blockbuster status in its first year on the market, exceeding $100 million in sales. Slide 11 shows the year-on-year growth of…

Thanks, Ilissa. In 2012, we anticipate a number of potential approvals. We'll continue to advance our pipeline, and we'll generate and share clinical data that will help investors better gauge our growth potential post 2014. We anticipate a number of regulatory actions, including FDA decisions on: Alimta as continuation maintenance therapy for patients with nonsquamous non-small cell lung cancer; ERBITUX, both in first-line non-small cell lung cancer, as well as in first-line metastatic colorectal cancer; and Amyvid for the detection of beta-amyloid plaque. Now as we mentioned, at AHA in November, we shared encouraging Phase II results for our CETP inhibitor. We anticipate beginning Phase III trials for evacetrapib before the end of this year. We also expect to complete a number of important Phase III trials in 2012, including: the EXPEDITION studies for solanezumab for Alzheimer's disease; the TRILOGY study with Effient and ACS-medically-managed patients; and the PARAMOUNT and POINTBREAK studies with Alimta in nonsquamous non-small cell lung cancer. In addition, we'll complete a number of Phase III trials for dulaglutide and, in collaboration with Boehringer Ingelheim, for empagliflozin. We'll also complete the Phase IIb trial of the JAK1/JAK2 inhibitor being studied for use in rheumatoid arthritis in partnership with Incyte. Pending the outcome of this trial, our plan is to disclose both 3-month and 6-month data at medical meetings later this year. A number of these trial completions will likely generate public data disclosures during 2012 as indicated in red text on Slide 14. We also expect to disclose additional Phase II data for our anti-IL-17 monoclonal antibody being studied in psoriasis and for our novel basal insulin analogue being studied for both type 1 and type 2 diabetes. Slide 15 shows a summary of the 2012 financial guidance that we discussed in detail on our investor call…

[Operator Instructions] Our first question will come from the line of Tim Anderson with Sanford Bernstein. Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division: I have a few questions on solanezumab. The first is, can you confirm that if the 2 Phase III trials are positive that you would file a product for approval in the current year? The second comment is on the ECGs that you've added. This seems to suggest that maybe somewhere along the way, there may have been a CV signal of some sort. Is that the case? Or is this just routine monitoring? And then lastly on the futility analysis that was done. Is it a hard and fast rule that if you fall below the threshold of futility, that the trials would have to be stopped? Or is there flexibility on this sort of thing that might allow the trial to go on even if you were below that threshold?

Great, Tim. I think we'll have Jan take a crack at those. Jan?

Right. In relation to filings, we first need to see the data before we can really commit to exact data in that area. And we will communicate data second half this year. In relation to the ECG comment, first of all, the Data Monitoring Committee recommended that the 2 EXPEDITION trials continue as planned, and the ECG comment was related to the extension 2-year trial. Currently, there are 2 ECG recordings in the extension trial at 12 and 24 months, and the Data Monitoring Committee wanted us to add the 1 and 3 months monitoring as well. This is consistent with the level of monitoring we actually have in the blinded clinical trials. If we look at this population of Alzheimer patients, the average age is around 75 years in the studies. And in previous trials that we've had, for instance, with semagacestat, placebo responses for cardiovascular events were 6.5%. And so far, in the EXPEDITION studies, we have 6.4% of patients that have reported a cardiac adverse event, although we do not know currently if these subjects are receiving active treatment with solanezumab or placebo. But remember, again, the Data Monitoring Committee recommended we continue the studies as planned. The futility analysis was done in the way that was pre-agreed. And if we wouldn't have met the agreement, we would not have continued. So futility was not met according to the defined rules.

Tim, one other thing. We have been regularly monitoring cardiac adverse events in the pivotal studies. And we'll continue to do so, obviously, with enhanced testing in the extension study as well.

Our next question will come from the line of Jami Rubin with Goldman Sachs.

Just a follow-up on solanezumab. What -- and I may -- Ronika, you may have mentioned this, and I may have missed it. But what probability hurdle was used in assessing the futility of solanezumab? In other words, can you give us a sense for what probability of success the futility analysis showed? And also, Derica, in your 2014 guidance, just curious to know what probability of success you have built in for solanezumab in your revenue guidance by 2014?

So we'll have Jan take the first and Derica the second.

Futility was defined that all 4 of the primary endpoints, 2 in each of the 2 pivotal studies, having a 30% or lower probability of being positive at the study completion. So this, I think, repeats what Ronika said.

Derica?

And Jami, on your question in regards to sola's impact on 2014, it's fairly immaterial given the probability that we were assuming. We have not put that absolute number out there. But what I can say is that if solanezumab is not successful, it will not cause us to change our 2014 outlook.

I guess, Jami, one of the way to think about the futility is, as you're probably aware, we're measuring ADAS-COG and ADCS-ADL scales as the 2 co-primary endpoints in each of the 2 pivotal studies. If all 4 of those endpoints had a 30% or lower probability of being positive upon completion of the studies, then the futility criteria would in fact have been met. And as we've said, those criteria were not met.

We'll go to the line of Marc Goodman with UBS.

I guess a couple of questions. One is, can you comment on any major inventory changes in the quarter? Second, can you talk about the SGLT2 market, your product, how you think about your trials, just given what happened with dapa? And then third, on Effient, can you just tell us, if the TRILOGY trial does work, how does that change your spending?

Derica, you want to handle the major inventory change question? Ilissa, the SGLT2 and then either Derica or I will handle the TRILOGY investment question for you.

Sure. Mark, in regards to inventory changes in the quarter, we did see some inventory build, excuse me, in the wholesalers and a little bit in retail in the fourth quarter in December. It's a little bit higher than what we have typically seen, but we've also seen that basically being burned off here in the first few weeks of the month of January . So we didn't see anything significantly out of whack but was higher levels than we've seen historically.

Ilissa?

Regarding our SGLT2 molecule, we are aware of the FDA concerns on dapagliflozin, although we do not know if those concerns are related specifically to the molecule or to the class. We do believe that the SGLT2 inhibitor class is an important alternative treatment option for adult patients with type 2 diabetes. We are continuing our Phase III trials, and we will evaluate efficacy and safety at that time when they complete.

And then on TRILOGY, obviously, this is a trial that will give us a very interesting and useful information about using the dose 2.5 milligrams for maintenance as opposed to a higher maintenance dose in elderly and low body weight patients, that were those patients in the TRITON-TIMI 38 trial had a much higher incidence of bleeding. So looking very much forward to getting this data later this year, having a chance to present it at a medical meeting in the second half of the year, hopefully, as well. In terms of the investment required, I would not want to indicate to you that it does require a significant additional investment. We have a footprint already for this product with the ACS-PCI indication. We have a sales force also selling other cardiovascular drugs. And again, the data could be very helpful to substantiate the clinical profile of Effient, but would not necessarily lead to any significant ramp-up in marketing or selling expenditures behind the drug.

Our next question comes from Greg Gilbert with Bank of America.

Jan, what will the field learn in 2012 about the CETP mechanism that will be important for your program, if anything? And is a large outcome study in Phase III already factored into your midterm outlook, Derica, for that product? And if John is on the line, I was curious if you're seeing any increased likelihood of tax or repatriation reform?

Great. Jan, you'll start?

Yes. I guess my comment is that it remains to be seen what we will be learned. I think for -- to really learn the essence of the CETP mechanism, we need to have the outcome data for the top molecules that really affect HDL over 100% and, in addition, lower LDL. And so we need to do the final outcome studies to make the definitive conclusions.

Greg, in regards to your budgetary question around CETP, CETP is just one of many molecules that we have within our clinical portfolio. And so as I highlighted on other calls, the group is very adept here in our R&D organization, doing good portfolio management and managing within the budgetary guidelines that we have established. And we make trade-off all the time. And so as we go forward, depending upon what the decision is around CETP, that will be looked at in conjunction with other molecules that we have in development, and we'll make the necessary decisions to be able to make the right funding. As it relates to tax repatriation. For us, the thing that we've been most focused on, Greg, is not necessarily repatriation because that's still a onetime deal. The more systemic or sustainable element that we think is most important is the U.S. moving to a territorial system. And this is where we will essentially be on a level playing field with our competitors who are not domiciled in the U.S., and I think that's the most important element of tax reform as I look forward.

That comes from the line of David Risinger with Morgan Stanley.

So I apologize, I think you had mentioned the 4 primary endpoints for solanezumab. If you could just run through those again, please, that would be helpful. My second question, and I have 3 on solanezumab, is with respect to the timing completion, clinicaltrials.gov indicate that the 2 Phase III trials will be concluding in the second quarter. Is that still correct? And would that imply an early third quarter disclosure? And then, finally, with respect to solanezumab, how many endpoints have to be positive to declare the trial a success? For example, would you be able to file if you only hit 1 of the 4 primary endpoints?

Great, Dave. Jan, do you want to take maybe the first and third question? I'll be happy to fill in on the ct.gov portion.

Okay. There are 4 primary endpoints as was stated too in each of the 2 EXPEDITION trials. The first one is the ADAS-COG, which measures cognitive function with an emphasis on memory. The second one is the ADCS-ADL, which measures the ability to independently perform daily activities, such as eating, bathing or using the telephone. So it's a cognitive subscore and an activity of daily living inventory. And there are one of each done in each study, making it 4 all together.

And in terms of the -- how many of the endpoints are going to be positive for filing. Do you want to comment on that, Jan?

The studies have been powered so that we need to hit statistical significance on all 4 primary endpoints across the 2 studies. On the other hand, there are secondary endpoints and there could be subgroup analysis being done, and it will end up in a discussion with the FDA. Remembering also that this is a disease area with a very high unmet medical need, and there are no disease modifying treatments available. And, of course, it's about the benefit/risk judgment overall.

And then, Dave, on the clinicaltrials.gov information, you're right, it shows both trials completing as is stated on clinicaltrials.gov in April and June of 2012. Just for clarity, that would be the last patient visit that would generate the data necessary to go ahead and actually close that database. In many trials, that takes a number of weeks. This may take a bit longer given the number of tests that are being done and different kinds of imaging that are being done. So it will be a larger number of weeks, post last patient visit before we actually close those databases, clean and validate them and begin to have a readout of the data. So I don't know that I'd indicate to you the early Q3 disclosure. We typically have been trying to set the expectation. We will present this data before the end of the year at a medical meeting, and then we'll evaluate with our team, with a PC council based on the data, what is an appropriate disclosure strategy, if any, prior to a scientific disclosure at a medical meeting.

We'll go to the line of Steve Scala with Cowen.

I have 3 questions. First, does Lilly know how many of the solanezumab endpoints achieved the 30% hurdle and you are simply not disclosing this? Or does Lilly not know? Secondly, what is the nature of the cardiovascular events seen in the trials, are they of rate or rhythm? And what is the hypothetical mechanism by how these disturbances would be delivered? And then, third, Lilly has said in the past that for financial modeling consideration, solanezumab had a low probability of success. Having crossed this interim hurdle, does Lilly still feel that the product has a low probability of success?

Jan would like to handle the first 2, and I'll take a crack at the last one.

Right. The Data Monitoring Committee did not say how many of the primary endpoints exceeded the threshold for futility, so we cannot comment on that. In relation to the nature of the cardiovascular events, we cannot be more specific at the current stage. And I refer back to my previous comment that, overall, there was a similar occurrence of CV events in the EXPEDITION trials in the -- which are blinded, compare them to the placebo events in the semagacestat trial.

And in terms of the financial modeling, Steve, you're correct saying in the past, that continues to be the case. Again, this is a disease state where there are no disease modifying therapies, things would delay the progression of Alzheimer's disease symptoms. And amyloid-beta hypothesis, while it's probably the leading hypothesis, is still that. We think this is one of the first molecules that will give that hypothesis a real test, and we're optimistic about the potential for helping to improve care for Alzheimer's disease patients, as well as their families. But this remains a very high risk area of research. We've also discussed the fact that it's particularly risky since we did not generate in Phase II the kind of efficacy data that you typically would have at that particular point in time. So for that reason, if this relatively high-risk, relatively lower probability Phase III asset were not to work, that would not have a significant impact on our future financial projection, given that relatively low probability. If, however, it were to work, there could be a more meaningful upside to our financial projections. Again, I go back to Derica's comment as well, just given the timing for completion of studies, potential submission and approval, this is not a molecule that would be impacting our 2014 guidance in either of the 2 cases of either working or not working in these Phase III studies.

That will be from the line of John Boris with Citi.

Solanezumab question, just on manufacturing and sourcing strategy for solanezumab. Are you currently sourcing your clinical trials from smaller clinical batches? Or have you done 3 large-scale production batches on the product? And has the FDA inspected this item, where will you manufacture it from? And then second question for Derica. Japan, obviously, a bright spot in the quarter. I think some price cuts go into effect there, greater than 6% in April. Can you maybe walk us through what the potential implications of that are across your therapeutic categories that you participate in Japan?

John, I'll go ahead and handle your first question and pass it to Derica for the second. So in terms of manufacturing and sourcing strategy, we don't have a lot of details we can share at this point in time. We can say that this is something we're producing internally to Lilly and we'd be expecting to, not only for the clinical trial, but for commercial production as well. At this point, I do not have an update for you in terms of FDA being in to inspect. I would not anticipate that type of an inspection to occur until you have an active review ongoing. Obviously, since the trial is not yet completed, we've not yet submitted. We're not at that stage in the process with the agency. Derica?

John, as you saw, we had very strong performance in Japan, both for the quarter and for the year. And for the year, we grew 31% there, for the quarter, 27%. And the key brands driving that were brands such as Cymbalta, Zyprexa, Alimta and Forteo. As we think about 2012, we are anticipating the biannual price decrease. This year, as you've heard on our January 5 earnings call, we anticipate the impact of that price decrease being much larger than what we've seen historically, to the tune of about approximately $200 million. We won't know specifically until we actually see the price list that comes out. But it's across brands, like Alimta, where we've had huge volume growth there and potentially, Zyprexa.

That will be from the line of Tony Butler with Barclays Capital.

Back to solanezumab quickly. I realized this is not prospectively defined. But if, in fact, in post talk analysis, APOE4 status actually indicates that, say, carriers or noncarriers, whatever the case may be, demonstrate significance, but the overall trial were to fail the primary outcome. Would that actually be a fileable outcome as well? And I'm sorry to be specific, but, I mean, clearly, this is experimental and there are, obviously, some post talk opportunities. I'm just curious how you think about that. I appreciate it.

Jan, would you like to comment?

It could be an option, but this will be a discussion with the regulators, again, referring back to the unmet medical need and the benefit/risk of this molecule. But we are doing this analysis, and it could be one option.

We will go to the line of Seamus Fernandez with Leerink Swann.

I've got a few questions here. Just can you update us on the Emerging Market performance in the quarter? That's the first question for Derica. Second, on solanezumab, the median on-treatment time for solanezumab at the interim look, as well as at completion. And then, also, maybe for Jan. Jan, if you can just give us your thoughts on the Obama administration's argument that the mandate could potentially be removed without striking down PPCA. Can you just update us on what the industry's position is there? And then if it were to be removed, but PPCA stayed in place, what would that mean to the potential volume opportunity for the industry, if any?

Off the bat, let me tell you, we don't have the data on median time on treatment, either at the interim or upon completion. I don't know that we'll have that. We will certainly check and follow up after the call. Derica will handle the Emerging Markets question, and John, to you for the healthcare reform.

Seamus, we continue to see strong underlying volume growth in the Emerging Markets. Our total growth was 7% for the quarter in Emerging Markets, 10% for the year. If we look specifically at markets like China, we grew there 43% in the quarter and 31% for the year. And we're seeing us move or increase our competitive positioning in the area of diabetes, as well as oncology. And those were 2 key drivers of that growth. And we'd anticipate seeing continued strong volume growth in 2012 as well. But you will begin to see also the impact of some of the patent expiries in markets like Brazil and Mexico on products like Gemzar and Zyprexa that will dampen the overall revenue growth, but not the volume growth. John?

Seamus, obviously, with healthcare reform with the Affordable Care Act, there are a lot of things up in the air right now. We've been implementing this, obviously, from the beginning. It's had an impact on our income statement beginning several years ago. And we're feeling a little bit more of that impact this year because it's the first year the fee has kicked in. We're following all of this with great interest. Obviously, we're prepared for whatever eventuality. Obviously, if there's not -- if someone's following that move [ph], the mandate, I think that calls into question how the system's going to avoid the selection bias and, in essence, operate in a way that's affordable. But we'll continue to monitor that. And we're prepared to deal with any eventuality.

Seamus, just a quick follow-up as well on the Emerging Markets. So as Derica had mentioned we have 7% growth in Q4 and 10% for the year. If you look at that volume growth, it's been quite strong. As Derica mentioned, it was 16% in Q4 and 12% for the full year. And then just to place in context the $250 million potential hit from generics, that would equate to about 10% of our overall Emerging Markets business. So it would be a relatively substantial hit, but again, may mask some of the underlying volume growth in other products that aren't affected by patent expiration.

And that will come from the line of Jeff Holford with Jefferies. Jeffrey Holford - Jefferies & Company, Inc., Research Division: I just wonder if you can just give us a brief update on your insulin business in the U.S. in the fourth quarter. Just if there are any changes in market share or just general changes on pricing activities that have happened between you and Novo Nordisk in the fourth quarter?

Sure. So for the insulin business, we saw continued strong growth in Q4 both in Humalog and in Humulin. In Humulin, we saw not only continued strong growth with the Humulin ReliOn brand with Walmart. But also, as some of that annualized out, a bit more of our price dropping to the bottom line. Humalog, we continue to see very strong growth in a number of market segments, including some of the hospital and long-term care segments. As we have indicated, we do expect that given some of the decisions that were made, CVS Caremark principally, for example, for commercial, as well as Part D, that we'll likely see some erosion in market share at the very beginning of the year. But again, we remain very encouraged by the progress we've made to date and the trajectory that we're on.

And we'll go to the line of Chris Schott with JPMorgan. Christopher Schott - JP Morgan Chase & Co, Research Division: Just a couple of quick ones here. First on solanezumab, and sorry if I missed an answer to I think Steve's question earlier. Is there any theoretical CV concerns with solanezumab or just the mechanism in general? Second question was on pipeline and how you guys were thinking about the A-beta antibodies relative to the base inhibitors earlier in development. And then final question was on business development. Comments on the growing cash balance, I mean, can you just talk a little bit about the priorities at this point and what range of transactions you'd consider, specifically, how large you'd go? And as we think about BD, on the human pharma side of the business, you've got very big data readouts of solanezumab and other assets ahead. Does that -- how are you thinking about BD, given that how that data might play out could significantly alter the direction the company is headed and the type of assets you might pursue?

I think, Jan, the first 2 are probably for you. And then, Derica, the business development one at the end. Jan?

Yes, if we get back to the cardiovascular concerns potential for solanezumab, as far as we understand, there are no real theoretical risks identified with this particular mechanism, although binding the amyloid is a peripheral thing. So we need to be driven by the outcome data then, from these patients. If we look at the pipeline, yes, there are a number of antibodies addressing beta-amyloid even at the midportion of the molecule like solanezumab, the N-terminal portion then, like some other agents. And earlier, there are oral agents, the base inhibitor, which we have one. And if we look at the positioning of these molecules, the base inhibitor then prevents the formation of amyloid, while then solanezumab actually removes or prevents aggregation of amyloid. So there are partly different mechanismal actions. It's also an opportunity for the next generation of amyloid agents to a more prospective use beta-amyloid imaging to actually identify amyloid-carrying patients that have mild cognitive impairment, for instance. And that could be the next step then to look into how you can really modify Alzheimer's disease progression.

Derica?

Okay. Chris, our focus on business development and direction has not changed. And going forward, we expect it to be fairly consistent with what you've seen from us historically. And our footprint has been -- we've done deals like Axiron, which we can easily slot into our ED business and footprint -- commercial footprint. We did the deal and the collaboration with Boehringer Ingelheim, where we're able to bring in 2 molecules that we could leverage our diabetes focus. And at the same time, outside of human pharma, we've followed the same approach as it relates to our Elanco Animal Health business. And most recently, we acquired ChemGen, which was an enzyme business, a feed-added business that we were able to slot into our existing Animal Health footprint. So those are the kinds of deals that we've been focused on historically, and I would see us following that similar pattern going forward.

Yes, I would say on Animal Health -- this is Jeff Simmons. I would just build on that. As mentioned, 5 acquisitions in 5 years, all of those, to build on Derica's strategy were strategic in nature, bringing us into the vaccine business, the companion animal business, expanding their European business with the Janssen last year. Dairy, with the Monsanto acquisition. And this recent one, to allow Elanco to continue a double-digit growth through YZ. It will accelerate us in this great interesting space of enzymes.

We'll go to the line of Catherine Arnold with Credit Suisse. Catherine J. Arnold - Crédit Suisse AG, Research Division: I'd like to just touch quickly on one quick question on solanezumab. The volumetric MRIs that you're doing, are those likely to come out in tandem with the broader results of Phase III? Is there any chance those are before or after? And then on evacetrapib I was wondering if you could just give a little bit of color about how you're thinking about a Phase III trial. There's obviously a big variance between the Roche program and the Merck program of number of patients in their Phase III trial? And are you thinking more in the 30,000 patient level or the 16,000 patient level? Are you thinking about a partnership or not? And then could you remind us whether or not you guys have an open label for your Phase II for evacetrapib?

Jan, do you want to try to handle the first 2 questions on the volumetric MRIs and on evacetrapib?

Yes. Volumetric MRIs is a readout that certainly we will try to include with all the other readouts that we have for the solanezumab trial. For evacetrapib, we are in regulatory discussions about our Phase III programs, and we cannot share any comments today about this outcome, which also includes then potential business development.

Catherine, one thing we have said about the programs for evacetrapib while we're still in the planning phases, we did go ahead in Phase II and look at this in combination with a number of statins that are commonly used, whereas, I believe, some of the others have been looking at a combination with a single statin. So clearly, we'll also be evaluating that as we set our Phase III plans. And I believe there is an open label extension to the Phase II, but I think we'll need to go ahead and double check on that for sure with you.

And I'll turn it back over to you, sir.

Okay, great. Before we go ahead and conclude the call, I would like to take a moment to thank our colleague, Ronika Pletcher, for her contributions to our Investor Relations efforts over the last 3.5 years, plus a little bit. I know many of you have worked with her pretty closely, and we appreciate her contributions. I'll also want to thank you that have dialed in today for your interest in Eli Lilly & Co, We definitely look forward to keeping you appraised of the progress we make during the course of 2012. And the IR team, as always, will be available post the call to answer any questions you may have. Thank you very much, and have a great day.

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