Earnings Labs

AbbVie Inc. (ABBV)

Q4 2015 Earnings Call· Fri, Jan 29, 2016

$204.92

+3.65%

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

-0.93%

1 Week

-3.24%

1 Month

+1.46%

vs S&P

-1.27%

Transcript

Operator

Operator

Good morning, and thank you for standing by. Welcome to the AbbVie Fourth Quarter 2015 Earnings Conference Call. All participants will be able to listen only until the question-and-answer portion of this call. I would now like to introduce Mr. Larry Peepo, Vice President of Investor Relations.

Larry Peepo - Vice President-Investor Relations

Management

Good morning, and thanks for joining us today. Also on the call with me are Rick Gonzalez, Chairman of the Board and Chief Executive Officer; Michael Severino, Executive Vice President of Research & Development and Chief Scientific Officer; and Bill Chase, Executive Vice President of Finance and Chief Financial Officer. Before we get started, I remind you that some statements we make today may be considered forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Additional information about the factors that may affect AbbVie's operations is included in our 2014 Annual Report on Form 10-K and in our other SEC filings. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand AbbVie's ongoing business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to Rick. Richard A. Gonzalez - Chairman & Chief Executive Officer: Thank you, Larry. Good morning, everyone, and thank you for joining us today. This morning, I'll briefly discuss our fourth quarter performance, and our 2015 operational highlights. Mike will then provide updates on recent advancements across our R&D programs, and Bill will discuss the quarter, and our 2016 guidance in more detail. As always following our remarks, we'll take your questions. We delivered another strong…

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Bill, we'll now open the call for questions. Sheryl, we'll take our first question, please.

Operator

Operator

All right, sir. Thank you. Our first question comes from Mr. Chris Schott of JPMorgan. Sir, your line is open.

Christopher Schott - JPMorgan Securities LLC

Analyst · JPMorgan. Sir, your line is open

Great. Thanks very much and thanks for the questions. Richard A. Gonzalez - Chairman & Chief Executive Officer: Sure.

Christopher Schott - JPMorgan Securities LLC

Analyst · JPMorgan. Sir, your line is open

First one here, just any perspective on the recent Amgen IPR decision on your formulation patent and what that means for HUMIRA. And maybe while we're talking about IP, maybe – any touch as well on the Coherus and BI filings on your dosing patents. That will be my first question. Second one, the mid-single digit growth for international HUMIRA, can you just elaborate a little bit more on the drivers and assumptions there. Specifically, what are you anticipating in terms of pricing or volume competition when we think about biosimilar Remicade and Enbrel? Thanks so much. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. Hi, Chris. It's Rick. So, I'll cover those two. Let me do the HUMIRA one first. So, as we mentioned in our previous call, we are anticipating that we will see indirect biosimilar competition outside the U.S. meaning Enbrel biosimilars outside the U.S. this year. So, if you think about our growth rate, we finished this year internationally at about 8.6% and we're guiding for next year at about mid-single digits. And you can break it up into sort of two components. One would be obviously as the brand gets a little bit bigger, the growth rate as a percentage is slowing down a bit. And then we have built in what are a set of assumptions of what kind of price impact we might see from Enbrel in certain markets, particularly in Europe I would say. And that represents about 2% of our growth. So you can think of it coming down about 2% based on that. So that's the HUMIRA piece. On the Amgen IPR and the other IPRs, I think in general across all of the litigation aspects of HUMIRA, I think it's important to recognize that we have now…

Christopher Schott - JPMorgan Securities LLC

Analyst · JPMorgan. Sir, your line is open

All right. Thanks very much.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Chris. Next question, please.

Operator

Operator

Our next question comes from Ms. Jami Rubin of Goldman Sachs. Ma'am, you're line is open. Jami Rubin - Goldman Sachs & Co.: Thank you. I just want to talk about U.S. HUMIRA sales this past quarter. I guess, 20% or 21% was a bit below consensus expectations. If you look at volume growth and price contribution, that should have led to slightly higher growth. I'm wondering if you can talk about what is happening to net price increases, are they sticking? And with respect to your high-teens guidance for U.S. HUMIRA sales in 2016, what again are your assumptions for price? Thanks very much.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Jami. William J. Chase - Chief Financial Officer & Executive Vice President: Hi, Jami. It's Bill. Look, I think we've seen spectacular growth numbers out of HUMIRA in the U.S. all year long, and certainly Q4, 21% isn't a bad number. And if you look at the market, TRx growth right now in the quarter was about 13%. From an inventory standpoint sequentially quarter versus quarter, it stayed roughly flat at a little less than half a month. But one thing that is impacting this number is we had slightly higher inventory numbers in the channel in Q4 2014. And if you adjust that out, it pretty much gets you back to where guidance had us. So we haven't seen anything on this brand that would lead us to pause and restate our expectations. And as I said in the call, in my comments, we're expecting high-teens growth, so it's going very well. From price perspective, it's normal for these sorts of products to take price increases towards the end of the year or the beginning of the year. We certainly have done that at the beginning of the year. So there is going to be a price dynamic on HUMIRA in 2016, and we want to see how things pan out as the year progresses above and beyond that. Richard A. Gonzalez - Chairman & Chief Executive Officer: And Jami, this is Rick. The only thing I would add is much like the discussion we had last quarter about international third quarter, if you look at our ordering or if you look at our growth rate patterns over the last several years, what you'll see is typically fourth quarter is a little bit lower from a growth standpoint. But I think what you're asking is are we seeing any kind of a slowdown in the U.S.; we're not. The U.S. is performing very robustly. We guided, I think, at the beginning of this year to about the same number, high teens, and obviously overachieved that. So I mean, we feel very good about the performance going forward with HUMIRA. Jami Rubin - Goldman Sachs & Co.: Thank you.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Jami.

Operator

Operator

Our next question comes from Mr. Marc Goodman of UBS. Sir, your line is open.

Marc Goodman - UBS Securities LLC

Analyst · UBS. Sir, your line is open

Yes. Good morning. You mentioned the HUMIRA price increase which was like 10-ish%. How much of that is actually flowing through to the bottom line this year that you project and how has that changed as far as the growth scenario in the past couple of years? And then second, if you could talk about hepatitis C a little bit. Obviously, the U.S., there's one dynamic and obviously with Merck coming in, they got approved. They set their pricing last night. If you could comment on that. And then secondly, if you could talk about Japan, where we are and how it's doing. I know you didn't have a lot of Japan in the quarter, but now it's been a good month and a half later. So, maybe you could just give us a sense for how Japan is doing in the ramp and how much Japan is going to be a piece of that O-U.S. this year. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. So, let me take the HUMIRA price piece. I understand all of the focus on price. I mean, I think all of us in this industry recognize all of the headlines we've seen around price and I think an important perspective to step back and think about for our business. This is not a business that is highly dependent upon price, our business I'm talking about. So if you look at our operational growth in 2015 of 22%, only 2% of that was price across the business. And if you look at HUMIRA, roughly around 25% of the overall growth is driven by price. Now, you do have certain managed care contracts that have some level of price protection, so all the price doesn't fall through at 100%. And depending upon where…

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Marc. Next question please, Sheryl.

Operator

Operator

Our next question comes from Mr. Mark Schoenebaum of Evercore ISI. Sir, your line is open.

Mark J. Schoenebaum - Evercore ISI

Analyst · Evercore ISI. Sir, your line is open

Hey, guys. Thanks. Wondering if I could take a left turn here away from hep C and drug pricing and talk a little bit about your pipeline, which is arguably not discussed a lot on the Street. So, number one, I'd love to – and also competition. So, first of all, I'd love to get your thoughts on there's been a lot of news in the JAK space. I'd love to get your thoughts comparing baricitinib to 494. I'd also love to get an update on how you're thinking about ABT-122 and ALX-0061. What's the next step, when we make a next step? And if possible, throw in a comment about ACP-196 versus IMBRUVICA. This molecule has obviously come into the headlines after AZN paid, I think, $7 billion for it. Thank you very much.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Mark. Michael E. Severino - Executive Vice President, Research & Development and Chief Scientific Officer: Sure, Mark. This is Mike. I'll take those questions. Your first question was about our JAK franchise and competition. I think that if we look at JAK inhibitors, there had been a fair amount of enthusiasm several years ago that actual results didn't live up to expectations for the first generation of those molecules, such as tofacitinib. But the current generation, I think, have very nice profiles. And I think baricitinib has generated a nice profile based on the data that we've seen today. We'll see more as they proceed through the regulatory review. And I think the class is going to get used over time. What we see with this class is, it tends to start slow and build over time and work from more resistant patients up to all the other lines of therapy, and we see that with therapies in RA and in immunology in general. So when I compare the two, I feel very encouraged by the results that we've seen with ABT-494. We've seen very strong efficacy, not just at the ACR20 level, but at much higher levels of response, ACR50, ACR70, DAS remission, et cetera. And we've seen that across two large Phase IIb studies, including a TNF-inadequate responder study, and those are the results that I mentioned in our opening comments. And there, we see a level of response in TNF-inadequate responders that we believe has the potential to be best-in-class. And so if you link that up with what I said about how RA dynamics play out, those data can be very important, and we believe that that is a big opportunity for this molecule. We do believe over time that 494 will certainly have use in earlier lines of therapy. But when you look at the balanced profile of 494, we feel very good about it. So moving on to ABT-122 and Ablynx, those are in mid-stage trials, and we'll see data from ABT-122 mid-year, and from Ablynx towards the back end of the year. And once we have those data, then that'll be the time to make decisions about next steps, so we'll be sharing those data as soon as it's reasonable to do so after we get them.

Mark J. Schoenebaum - Evercore ISI

Analyst · therapy, and we see that with therapies in RA and in immunology in general. So when I compare the two, I feel very encouraged by the results that we've seen with ABT-494. We've seen very strong efficacy, not just at the ACR20 level, but at much higher levels of response, ACR50, ACR70, DAS remission, et cetera. And we've seen that across two large Phase IIb studies, including a TNF-inadequate responder study, and those are the results that I mentioned in our opening comments. And there, we see a level of response in TNF-inadequate responders that we believe has the potential to be best-in-class. And so if you link that up with what I said about how RA dynamics play out, those data can be very important, and we believe that that is a big opportunity for this molecule. We do believe over time that 494 will certainly have use in earlier lines of therapy. But when you look at the balanced profile of 494, we feel very good about it. So moving on to ABT-122 and Ablynx, those are in mid-stage trials, and we'll see data from ABT-122 mid-year, and from Ablynx towards the back end of the year. And once we have those data, then that'll be the time to make decisions about next steps, so we'll be sharing those data as soon as it's reasonable to do so after we get them

What are the hurdles for success in those trials? Michael E. Severino - Executive Vice President, Research & Development and Chief Scientific Officer: Well, our general approach has been that we believe we need to raise the standard of care. So what we're going to want to see is something that is over and above the level of efficacy that can be achieved with comparable agents, if you will. So ABT-122 combines 17 in TNF, so you're going to want to see something in the disease populations we've studied in RA and in psoriatic arthritis. It's better than one can get with those mechanisms alone. And Ablynx is another approach at IL-6, you'll see something that's better than the existing therapies that are out there. Now, obviously, these aren't comparative studies, but we'll have the data, we believe, to make those assessments and to determine whether we will advance those programs this year, as I've said. So, with Acerta, there certainly has been a lot of talk about Acerta given its relatively early stage of development. What I would say, first and foremost, is we've set a very high bar with IMBRUVICA. We've set a very high bar with efficacy and also with safety. I quoted some of the numbers from RESONATE-2. We don't believe we've left any room on the table for there to be a story of improved efficacy. And we feel very good about the safety profile of IMBRUVICA. With Acerta, we're looking at much earlier data. We're looking at Phase Ib, Phase IIa studies. I think the study that's garnered the most attention is about a 61-patient dose rising study with an expansion. And it's really just not possible to compare those very early trials to a molecule like IMBRUVICA which has multiple phases of readouts and has been on the market now for a considerable period of time. So we'll see as their programs continues to progress, what they're able to demonstrate. They have comparative studies, so a readout in a couple of years' time, and I think that's really the first time we'll be able to make any sort of comparative assessment. Those are open-label studies, and that's a limitation of them. And I'll also add that Acerta's comparative studies are in relapsed/refractory patients, and IMBRUVICA is moving to the front-line over time. And that momentum is going to keep up. So we feel very confident in our position with IMBRUVICA.

Mark J. Schoenebaum - Evercore ISI

Analyst · therapy, and we see that with therapies in RA and in immunology in general. So when I compare the two, I feel very encouraged by the results that we've seen with ABT-494. We've seen very strong efficacy, not just at the ACR20 level, but at much higher levels of response, ACR50, ACR70, DAS remission, et cetera. And we've seen that across two large Phase IIb studies, including a TNF-inadequate responder study, and those are the results that I mentioned in our opening comments. And there, we see a level of response in TNF-inadequate responders that we believe has the potential to be best-in-class. And so if you link that up with what I said about how RA dynamics play out, those data can be very important, and we believe that that is a big opportunity for this molecule. We do believe over time that 494 will certainly have use in earlier lines of therapy. But when you look at the balanced profile of 494, we feel very good about it. So moving on to ABT-122 and Ablynx, those are in mid-stage trials, and we'll see data from ABT-122 mid-year, and from Ablynx towards the back end of the year. And once we have those data, then that'll be the time to make decisions about next steps, so we'll be sharing those data as soon as it's reasonable to do so after we get them

Thanks a lot. Richard A. Gonzalez - Chairman & Chief Executive Officer: The only other thing I'd add is – this is Rick.

Mark J. Schoenebaum - Evercore ISI

Analyst · therapy, and we see that with therapies in RA and in immunology in general. So when I compare the two, I feel very encouraged by the results that we've seen with ABT-494. We've seen very strong efficacy, not just at the ACR20 level, but at much higher levels of response, ACR50, ACR70, DAS remission, et cetera. And we've seen that across two large Phase IIb studies, including a TNF-inadequate responder study, and those are the results that I mentioned in our opening comments. And there, we see a level of response in TNF-inadequate responders that we believe has the potential to be best-in-class. And so if you link that up with what I said about how RA dynamics play out, those data can be very important, and we believe that that is a big opportunity for this molecule. We do believe over time that 494 will certainly have use in earlier lines of therapy. But when you look at the balanced profile of 494, we feel very good about it. So moving on to ABT-122 and Ablynx, those are in mid-stage trials, and we'll see data from ABT-122 mid-year, and from Ablynx towards the back end of the year. And once we have those data, then that'll be the time to make decisions about next steps, so we'll be sharing those data as soon as it's reasonable to do so after we get them

Hey, Rick. Richard A. Gonzalez - Chairman & Chief Executive Officer: When we did the acquisition of Pharmacyclics, we did it with the knowledge of Acerta. So we thoroughly reviewed, based on the information we had at that time, the compound and evaluated whether or not we thought it was a risk. And I think one of the things to keep in mind is a follower strategy in oncology, at least historically, has not worked very well. And the reason it doesn't work very well is if the innovator keeps advancing the bar, the regulatory environment changes on the follower and what they need to do to be able to get their approvals, it's more difficult, takes more time, it's more expensive because it can't do single arm studies to get approval. The second thing I'd say is there seems to be two theses out there. One would be improved efficacy, one would be improved safety profile, particularly around bleeding and AFib. I wouldn't say that those are issues that are inhibiting our ability to be able to advance the brand and standard of care today. But what I'd also say is as we have evaluated it, we believe that the vast majority of the data would support that those are on-mechanism side effects. And so we'll have to see what their data proves out and we'll have to see what their inclusion and exclusion criteria is on the trials that they run to make sure it's a balanced view to be able to demonstrate what the bleeding AFib rate would be. And remember, we didn't see AFib in IMBRUVICA until we got to something like 1,500 patients or so. And I think we saw bleeding at about 500 to 600 something like that, right? So we have to see a lot more data to see a real signal, and it has to be in the population that's consistent with the population that's being treated. And we'll see what the data looks like, but I think the evidence today would suggest that those are on mechanism. And so we'll have to see how it plays out, but I would tell you that we're confident in our position with IMBRUVICA.

Mark J. Schoenebaum - Evercore ISI

Analyst · therapy, and we see that with therapies in RA and in immunology in general. So when I compare the two, I feel very encouraged by the results that we've seen with ABT-494. We've seen very strong efficacy, not just at the ACR20 level, but at much higher levels of response, ACR50, ACR70, DAS remission, et cetera. And we've seen that across two large Phase IIb studies, including a TNF-inadequate responder study, and those are the results that I mentioned in our opening comments. And there, we see a level of response in TNF-inadequate responders that we believe has the potential to be best-in-class. And so if you link that up with what I said about how RA dynamics play out, those data can be very important, and we believe that that is a big opportunity for this molecule. We do believe over time that 494 will certainly have use in earlier lines of therapy. But when you look at the balanced profile of 494, we feel very good about it. So moving on to ABT-122 and Ablynx, those are in mid-stage trials, and we'll see data from ABT-122 mid-year, and from Ablynx towards the back end of the year. And once we have those data, then that'll be the time to make decisions about next steps, so we'll be sharing those data as soon as it's reasonable to do so after we get them

Thanks, Rick.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Mark. Next question, please.

Operator

Operator

Our next question comes from Mr. David Risinger of Morgan Stanley. Sir, your line is open. David R. Risinger - Morgan Stanley & Co. LLC: Thanks very much. So, I wanted to go back to the positive IPR decisions. Could you please characterize the breadth of those two patents, the 157 and 158 patents which were surprisingly upheld? Specifically, you must have an opinion on the likelihood that other biosimilar manufacturers beyond Amgen will infringe these patents because it's challenging to make a stable monoclonal antibody without infringing. And then second, I'm interested in your perspective on duration of therapy for IMBRUVICA currently and how you expect that to evolve with new indications. And then also if you could share any thoughts on venetoclax on that front with respect to expected duration of therapy as well, that would be very helpful. Thank you.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, David. Richard A. Gonzalez - Chairman & Chief Executive Officer: Yeah. David, this is Rick. On the IPR part, I guess what I'd say is it wasn't surprising to us. We obviously have a pretty high level of confidence in the IP. As far as others that would infringe, I mean, we're certainly not in a position to be able to answer that question because we don't know what their formulations are. I guess the best place to get that answer would be to ask them. But as I said, we're not going to talk a lot about how we're positioning things and how we plan on running the IPR process going forward. The most important thing here is that we prevail. And I realized that probably doesn't give you great comfort, but you have to recognize our responsibility is to make sure that we put the best position forward and that we don't tip off our opponents in this process as to what our strategy is. And so I apologize for that part of it, but that's the tradeoff we have to make here. And you're going to see more of this play out over time and I think you'll get a feel for it and you can get other people to evaluate what you think that will look like from an IP standpoint, although I'd say much like this particular patent, some people opine that they didn't think it was very strong and you saw at the patent office made their decision, right? So, I think that's about all we can talk about as it relates to the litigation. The second would be on duration on therapy on IMBRUVICA. If you look at the duration on therapy today, I'd say it's tracking on what we expected as…

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, David. David R. Risinger - Morgan Stanley & Co. LLC: Thank you.

Larry Peepo - Vice President-Investor Relations

Operator

Next question, please, Sheryl?

Operator

Operator

Our next question comes from Ms. Vamil Divan of Credit Suisse. Ma'am, your line is open. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): Yeah. It's actually – this is Vamil. Thanks so much...

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Vamil. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): ...for taking my questions. Hi. How are you doing? I get it. All sorts of interesting moves with my name. But anyways, a couple of questions if I could. One, just in terms of hep C, I appreciate the comments you made for next year and how are you looking to that. Can you give us a sense have you've seen any impact on prescription trends from the label change that you had to make back near the start of the fourth quarter and if that's impacted things at all? And then maybe on the pipeline again, I appreciate all the comments that were made earlier also in response to Mark's question. Maybe if you could just streamline things a little bit and just flag, if you could, the two or three most important data releases that you think investors should be focused on for AbbVie between now and your June R&D day? Thanks so much. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. Vamil, this is Rick. I'll take the HCV one. We have seen an impact. Maybe the best way to describe it would be this, you saw what our revenues were in the fourth quarter. We had flagged that the $3 billion running rate in the fourth quarter that we thought we – I flagged that we might miss it, but we would be relatively close and that is what we have been tracking against for the fourth quarter. I'd say in the fourth quarter, there were two impacts, and one of them is going to be a label change. That's why I'm going through this explanation for you. So one was the VA volumes stayed very low through the fourth quarter because…

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Vamil. We'll take our next question, please.

Operator

Operator

Our next question comes from Alex Arfaei of BMO Capital Markets. Your line is open.

Alex Arfaei - BMO Capital Markets

Analyst · BMO Capital Markets. Your line is open

Good morning, folks, and thank you for taking the questions.

Larry Peepo - Vice President-Investor Relations

Operator

Good morning.

Alex Arfaei - BMO Capital Markets

Analyst · BMO Capital Markets. Your line is open

Obviously, there's quite a bit of skepticism about your 2020 HUMIRA guidance. And given what you said today about Europe and the fact that biosimilar competition will only increase there, can you help us understand how you get there, basically help us bridge the difference between where consensus is right now to your expectation for greater than $18 billion by 2020 for HUMIRA? And then I'm curious about what are some of the things that you'll be looking for during the upcoming Remicade biosimilar FDA panel? Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. So, Alex, this is Rick. If you think about what we described for you on the 2020 HUMIRA guidance ex-U.S., we basically said that we would see direct biosimilar competition in the fourth quarter of 2018. We'd have some impact from indirect biosimilar starting in 2016. I described earlier in the call what that impact assumption is for 2016. It will obviously have a flow-through impact into 2017, as that expands and basically flows through. But then, if you think about the erosion curve that I described on the third quarter call. So what we said was internationally, the brand will peak in 2018 and then it will gently start to decline and if you get to the end of 2020, it's down about 15% or so. That's a combination of volume and price. Now, I'd also tell you that because the category is still growing, obviously then the growth would have been there and some of that growth went to a biosimilar player. So it basically says, that about 30% of the total opportunity would have gone over that period of time. And, that's the point at which we see some level of stabilization going forward. So I think that's the…

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Alex. Operator, we'll take our next question, please.

Operator

Operator

All right, sir. Thank you. The next question comes from Mr. Steve Scala of Cowen. Your line is open. Stephen M. Scala - Cowen & Co. LLC: Thank you. You mentioned the $2 billion in VIEKIRA sales in 2016. That is less than annualizing Q4 2015 sales, which were already a bit held back as you described a couple of minutes ago. So it seems as these expectations – or you're expecting a slowdown quarter-over-quarter in 2016, despite the launch in Japan. So, where are you expecting to see the pressure? Secondly, where specifically in Merck's hep C label does AbbVie see competitive advantages for VIEKIRA, if any? And then lastly, what has been the uptake of the new formulation of HUMIRA in the EU? Thank you very much. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. Steve, this is Rick. I'll take the first one. So, you are correct that if you look at what we're guiding going forward, it is less than our fourth quarter annualized. And that is our intent. I'd say there's two factors there. Let's be honest, we've had trouble predicting this number. And so we wanted to go into 2016 with a number that we had a very high level of confidence that we could hit, so that's certainly a component of it. The second component is we are assuming some level of competition from Merck. So, we'll have to see how it plays out, but I would say we're going to set this one at a number that we have a high level of confidence that we think we can deliver, and I'd much rather surprise you on the positive than sit here and apologize on the miss. And Mike, why don't you cover the label? Michael E. Severino - Executive…

Larry Peepo - Vice President-Investor Relations

Operator

Thanks. Next question please, operator.

Operator

Operator

Our next question comes from John Boris of SunTrust. Your line is open.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Analyst · SunTrust. Your line is open

Thanks for taking the questions and congratulations on the results. Richard A. Gonzalez - Chairman & Chief Executive Officer: Thanks, John.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Analyst · SunTrust. Your line is open

First question has to do with the Japanese market. Are you anticipating any impact to your franchises from price decreases in Japan in April? The second question, what percent of HUMIRA revenues in U.S. and ex-U.S. come from rheumatoid arthritis? And can you give some color on timing around when the pen might see or secure approval? And then last question just has to do with ABT-494. It seems that competitively baricitinib and the developers there have latched on to an important area of diabetic nephropathy that appears to have an effect; that would be a very large untapped market. I'm sure you'll talk about this in June, but any thoughts around further broadening the development outside of RA for ABT-494? Thanks. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. So, John, this is Rick. I'll take the first one. So the Japanese market price adjustments, we are aware of it, it has been communicated to us. So it's built into our 2016 guidance. I don't think it's something we can tell you because really the Japanese authorities need to release that, not us. But I'd say it was in the range, slightly lower than we would have expected. So I think it's fine and as I said it's in the guidance already. But we are aware of what the number is. The HUMIRA indication mix, it was RA you said? William J. Chase - Chief Financial Officer & Executive Vice President: Yeah. RA, John, right now is just a bit under 35% of global sales. Richard A. Gonzalez - Chairman & Chief Executive Officer: And then the pen devices, they were submitted recently. So we're thinking second half of 2016.

John T. Boris - SunTrust Robinson Humphrey, Inc.

Analyst · SunTrust. Your line is open

Thanks. Richard A. Gonzalez - Chairman & Chief Executive Officer: And then ABT-494, Mike? Michael E. Severino - Executive Vice President, Research & Development and Chief Scientific Officer: Sure. This is Mike. So with respect to broadening out ABT-494 development, we obviously believe that ABT-494 has broad potential in RA. In other immunologically mediated conditions, we have programs underway in inflammatory bowel disease, and I think the data support that we're likely to see a good effect there. With respect to diabetic nephropathy, it's an intriguing idea. It's certainly something we consider. And perhaps that is a good topic for our R&D Day in June.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, John. Appreciate the question. Next question please, operator?

Operator

Operator

Our next question comes from Colin Bristow of Bank of America. Your line is open.

Colin N. Bristow - Bank of America Merrill Lynch

Analyst · Bank of America. Your line is open

Morning, and thanks for taking the questions and all the useful color. So first on HUMIRA, just in the 4Q, can you comment specifically or at least qualitatively on the level of rebating in the quarter and how it compares year-over-year and sequentially? Second on hep C, can you give us some idea of the number of contracts perhaps as a proportion of 2015 which you secured with exclusivity for 2016? And then thirdly, and sorry if I missed this, but on the HUMIRA ex-U.S. front, can you give us an update on the impact you're seeing from biosimilar Remicade? I think previously you said around 3% share. And then just following on from that theme, how do you anticipate the threat from the biosimilar Enbrel given that it's an injectable versus an infusion? Thanks. William J. Chase - Chief Financial Officer & Executive Vice President: Colin, it's Bill Chase. On the rebating around HUMIRA, obviously, we don't go to any great lengths explaining the levels of rebating. What you need to think about with our pricing dynamic on HUMIRA is price increases in the latter half of the year tend to have less of a fall through that's related to basically pricing caps in certain programs. So to the extent that we take price later in the year, our rebate goes up for those particular programs, but I don't want to get into any specific numbers around that at this point in time. Richard A. Gonzalez - Chairman & Chief Executive Officer: On the HCV contracting, when we originally launched and the exclusive contracts that we had were multiyear contracts with the exception of the Medicaid contracts which many of those are annual contracts, get bid out on a yearly basis. So I'd say, certainly, the majority of our business is under a multiyear contracting strategy. On HUMIRA, Remicade, I may not have heard the question correctly, but we haven't communicated that it had a 3% impact, in fact it had virtually no impact on our business. Overall, if you look at their overall biologic share is somewhere around 3%, but the vast majority of that has come from Remicade. And then Enbrel is what I described earlier that we are anticipating about a 2% impact from a growth rate standpoint. The majority of that, the vast majority of that is price. There are certain markets where there will be a price impact.

Colin N. Bristow - Bank of America Merrill Lynch

Analyst · Bank of America. Your line is open

Great. Thank you.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Colin. And operator, we have time for one more question please.

Operator

Operator

All right, sir. Our last question comes from Mr. Andrew Baum of Citi. Sir, your line is open.

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst · Citi. Sir, your line is open

Thank you. Three questions, please. Firstly, you've expressed previously your confidence in the robustness of the 135 patent within the U.S. and I know it had a very lengthy prosecution history to attain inclusion in the USPTO. Could you contrast that with the withdrawal of the similar patents from Europe? What underpins the confidence in the U.S. building on the lengthy prosecution, if you'd like to comment? Second, perhaps if you could go into a little bit more detail in terms of the reference pricing for anti-TNF agents within Europe. What was the thinking of the impact of Enbrel in dragging down the prices of the category? And then finally, just on Acerta's BTK inhibitor, do you believe that they infringe AbbVie's intellectual property? Thank you.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Andrew. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. On the 135 patent as I said before, I mean we're not going to go through a lot of detail back and forth. But one thing I do want to clarify is remember, IP in Europe is different than IP in the United States in how it is ultimately prosecuted. The second thing is, it's important to remember that although we withdrew the parent patent, we did it because there was one particular assay that we had a second patent that didn't have that question and therefore we pulled that patent in order to basically just focus on these other patents. So it's not like we withdrew it because we were concerned about it. And so ultimately – but that is not an issue from a U.S. standpoint, and I think that's probably as much as we're going to talk about it. Reference pricing, obviously part of what I indicated earlier is reference price, but I'd say also there are some markets where there could be some hospital negotiations also that could have an impact here. And so we factored in what we think is certainly a conservative number. But I think it's an appropriate number to be able to ultimately plan for 2016. And then on Acerta BTK, the IP, again, we have significant IP in this area. And if we believe Acerta infringes that IP, we'll enforce the IP.

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst · Citi. Sir, your line is open

Thank you.

Larry Peepo - Vice President-Investor Relations

Operator

Thanks, Andrew.

Larry Peepo - Vice President-Investor Relations

Operator

And that concludes today's conference call. If you'd like to listen a replay of the call, please visit our website at abbvieinvestor.com. Thanks again for joining us.

Operator

Operator

That concludes today's conference. Thank you for participating. You may now disconnect.