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Transcript
OP
Operator
Operator
Good morning, and thank you for standing by. Welcome to the AbbVie First Quarter 2016 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.
LR
Larry Peepo - Vice President-Investor Relations
Management
Good morning, and thanks for joining us. Also on the call with me today 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. Henry Gosebruch, our Chief Strategy Officer, will be joining us for the Q&A portion of the call. In addition to our earnings release this morning, we have also issued a press release announcing our acquisition of Stemcentrx. You can find a set of slides on our website that provide an overview of the transaction. Before we get started, I remind you that some statements we make today may be considered forward-looking statements for 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 2015 Annual Report on Form 10-K and in our other SEC filings. AbbVie undertakes no obligation to release publicly any revisions to the 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…
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, Bill, and we'll open the call for questions, now. Jay, we'll take our first question, please.
OP
Operator
Operator
Thank you. We'll now being the question-and-answer session. Our first question comes from Jeff Holford from Jefferies. Your line is now open.
JL
Jeffrey Holford - Jefferies LLC
Analyst · Jefferies. Your line is now open
Good morning, everybody, and thanks very much for taking my questions. So, just for Stemcentrx, just because it's a company we all don't know so well, can you just help us a little bit more on the valuation? Was it primary driven by the last financing round that you cite or other things in terms of peak sales expectations of visible assets that's driving that? Secondly, also, just on that transaction, how much data beyond what's been publicly disclosed, i.e. some of the data perhaps that's coming to ASCO, was management able to see before agreeing to this deal? And then, my last question is just around the upcoming IPR decisions. Can you just confirm timing and expectations there, 18th of May, and do you expect these decisions to be consolidated? And then, just secondly to that, there's a patent adjustment out there that potentially takes the 135 patent out to 2028. If and when that's granted, which seems to be procedural, will you extend your HUMIRA exclusivity guidance on the back of that? Thank you very much. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. Hi, Jeff, it's Rick. So, I'll take, I guess, all of those questions. So, as it relates to the valuation, I would say it had nothing to do with what their prior round valuation was. That's not how we do acquisitions. Essentially, how we do acquisitions, and you probably recall this from the Pharmacyclics discussion that we had, and I think it's typical within our industry how it's done, is you build a model that ultimately projects out what you think the company and assets can do. And then, off of that model you determine what the return would look like at various price points, what the NPV would look like and,…
JL
Jeffrey Holford - Jefferies LLC
Analyst · Jefferies. Your line is now open
Thanks very much, and congratulations on the deal.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Yeah. Thanks, Jeff. Next question please.
OP
Operator
Operator
Thank you. Our next question comes from Chris Schott from JPMorgan. Your line is now open.
CL
Christopher Schott - JPMorgan Securities LLC
Analyst · JPMorgan. Your line is now open
Great. Thanks very much. Just a couple on the deal today. Maybe first, can you just talk about the competitive landscape for the DLL3 target or just other companies working on cancer or stem cells as an ADC target? Second question was on the $0.20 of dilution this year. I'm just trying to get a sense of what this is going to look like out in 2017. Should we be thinking about something larger than $0.40 as we get the full year impact and as you ramp R&D associated with these assets? And then, the final one was just, post this deal, can you just give us some sense of the position the company is to pursue larger transactions if the right opportunity were out there? Should we think about Stemcentrx is the type of size and profile you're looking for? Or could you look to get more aggressive as the year kind of – or as we go to 2017 if the right deal is out there? Thanks so much. Michael E. Severino - Executive Vice President, Research & Development and Chief Scientific Officer: So, this is Mike. I'll take the first question with respect to the competitive environment for Rova-T and some of the other programs that Stemcentrx has been working on. And what I'll say is that one of the things that really impressed us with Stemcentrx is the novelty of their platform. They've invested early in this technology. They have developed great expertise. And they are out in the lead in all of the areas that they're pursuing. So DLL3 is out in the lead. It's demonstrated very compelling results, and we think it's an asset that has tremendous promise and will really change the standard of care. And I think if you look at all…
CL
Christopher Schott - JPMorgan Securities LLC
Analyst · JPMorgan. Your line is now open
That's great. Thanks so much for the color.
LR
Larry Peepo - Vice President-Investor Relations
Operator
All right, thanks. Next question, please, operator.
OP
Operator
Operator
Thank you. Our next question comes from Jami Rubin, Goldman Sachs. Your line is now open. Jami Rubin - Goldman Sachs & Co.: Thank you. I just want to follow up on some of the Stemcentrx questions; and congratulations. But clearly the whole, sort of, stem cell based focus has been fraught with challenges, and I'm just wondering maybe if you could reply to the specific questions. What gives you confidence that findings from mouse models translate to human cancers? And also, what gives you confidence that small cell lung cancer data will translate to other tumor types? And was also curious to know how Stemcentrx's ADC technology differs from other ADC players. And then, a follow-up question, and sorry about this, but just to follow-up on an earlier question, if you could kind of play out the scenario of the upcoming IPR, which investors are obviously highly focused on, what is the right analytical framework, Rick, that we should think about this in the event that, A, the IPR is heard, or it is dismissed, just in relation to the overall IP picture and duration of HUMIRA? Thanks very much. Michael E. Severino - Executive Vice President, Research & Development and Chief Scientific Officer: All right. So, I will – this is Mike. I will take the first of those, and then Rick may want to add some follow up. So with respect to cancer stem cells, what I would say is we've had a fair amount of time to get very comfortable with the platform that Stemcentrx has developed. And we believe that they are doing something really novel here. In terms of understanding how mouse models might translate into human clinical trials or, ultimately, clinical benefit, we certainly recognize that that translational leap is often fraught with…
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, Jami. Operator, next question, please.
OP
Operator
Operator
Thank you. Our next question comes from David Risinger, Morgan Stanley. Your line is now open. David R. Risinger - Morgan Stanley & Co. LLC: Thanks very much, and congrats on the news this morning. I have three questions. First, with respect to Stemcentrx, could you just talk about how you plan to integrate and retain the employees now that they're going to be part of a much larger pharmaceutical company. Second, could you explain the Stemcentrx-Pfizer partnership and how you expect that to evolve? And then, as an aside, AbbVie doesn't talk much about your 50-50 funding along with Google of Calico, but obviously you have made a significant investment there and Calico is quite an interesting company given its leadership. Could you just update us on the pipeline at Calico as well, please? Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. So, David, this is Rick. I'll take probably the first of those and maybe some part of the second. I may ask Henry to chime in on the second part. And I'll take the Calico one for you. So, I mean, obviously, an important part of these kinds of companies is retaining the people. And – particularly, when you think about this kind of a company where a lot of the intellectual property of the company is that, right? It's the intellectual horsepower of the people. And I would say we have been interacting with Stemcentrx, now, for a number of months, well before this process started. And so, we've had a chance to get to know the team and get to know the leadership within the team. And they had a decision to make, right? They could have gone down the IPO route. They could have collaborated with somebody and gone down…
LR
Larry Peepo - Vice President-Investor Relations
Operator
All right. Thanks, David. Operator, next question, please.
OP
Operator
Operator
Thank you. Your next question comes from Marc Goodman, UBS. Your line is now open.
ML
Marc Goodman - UBS Securities LLC
Analyst
Yes, morning. Maybe we can talk a little bit about just the business for a sec. VIEKIRA was a little bit weak. Maybe you can talk about the U.S. versus international, how Japan is doing. U.S. seems to be falling off quite a bit; I mean, we're just losing share. Give us a sense of what's going on there. Second, HUMIRA in the U.S., I was just curious – obviously, we've seen quite a few price increases if you look out over the past 12 months, and I was curious whether you are still being able to get the same amount of price dropping to the bottom line as you have been in the past, if there was more pressure on that? And then, third, can you give us an update on what we're going to see at ASCO for the broader portfolio? Thanks. Richard A. Gonzalez - Chairman & Chief Executive Officer: Thanks, Marc. Okay. So, this is Rick. I'll take VIEKIRA , and Bill can take the HUMIRA question, and we'll have Mike cover the ASCO question. So, VIEKIRA, let me start with Japan. I mean, Japan is continuing to track consistent with our expectations, so I think there's nothing all that remarkable from Japan. It's a good market, and our profile within that market is a good profile. The U.S. has certainly been more challenging. I would say that it's a combination of several factors, some volume loss as well as some price loss. As Merck has entered the market, we know that they set the list price lower than the other products in the marketplace. That strategy, initially, I think we interpreted as a strategy that would go after medical exceptions, because medical exceptions historically are in at more of a list price point. And so,…
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, Marc. Appreciate it. Operator, next question, please.
OP
Operator
Operator
Thank you. Our next question comes from Andrew Baum, Citigroup. Your line is now open.
AL
Andrew S. Baum - Citigroup Global Markets Ltd.
Analyst
Hi. Three questions, please. First, on the Stemcentrx transaction, could you provide a little bit more detail on the earn-outs? The press release references milestones, and you mentioned in passing the first-line indication, but if you could provide some more granularity that would be great. Second, I would imagine this was a competitive auction just given – well, especially as Stemcentrx just got a finance professional as their CEO and there's several high-profile tech investors involved. Perhaps, you could just give us some sense of the competitive dynamics as you think about valuation. Second, in reference to your comment on your IL-23, you highlighted it as your priority compound in psoriatic arthritis. What's the future of ABT-122? Do you intend to proceed in either psoriatic arthritis, or is psoriasis or in RA for that compound? And then, finally, more broadly, now that you've got a lung candidate in your oncology pipeline, how you think about augmenting that compound going forward.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, Andrew. Richard A. Gonzalez - Chairman & Chief Executive Officer: So, Andrew – Henry, why don't you cover the milestones, and then we can talk a little bit about first-line. Henry O. Gosebruch - Chief Strategy Officer & Executive Vice President: Yeah. Hey, Andrew. So there are in total $4 billion of milestones. $2 billion relate to the first-line approval that Rick talked about. So that approval is $2 billion and is qualified by a favorable position in the guidelines at the time. And as Rick talked about, we believe that would create significantly more value than that $2 billion. In addition, there is a second $2 billion, and that relates to four individual $500 million milestones, so totaling $4 billion, and those are for the commencement of registration trials for additional assets in indications that would be at least $1 billion in revenue potential. So that is $500 million each for a total of $2 billion, and then with the first-line, $4 billion in total. Richard A. Gonzalez - Chairman & Chief Executive Officer: So, on those second set of milestones, just to be clear, they're individually earned, right? So if they take one asset and they move it through and we take it to a registration study and we determine that that asset in that indication would generate a commercial asset that had greater than $1 billion worth of revenue, then we would pay them $500 million. And then, if they do a second one or a third one and a fourth one, they can get up to four $500 million milestones. So that's how the contingent – or the contingent payments are laid out. On the competitive dynamics, it was a competitive process. It was relatively blind to us, so we don't know who the other…
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, Andrew.
AL
Andrew S. Baum - Citigroup Global Markets Ltd.
Analyst
Thank you.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Jay, we'll take our next question, please.
OP
Operator
Operator
Thank you. Your next question comes from Mark Schoenebaum, Evercore ISI. Your line is now open.
JI
John Scotti - Evercore ISI
Analyst
Good morning. This is John Scotti in for Mark. I just have a few questions, if I may.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Hey, John.
JI
John Scotti - Evercore ISI
Analyst
First – hey, Larry. The first on Stemcentrx. So I recall last year when you purchased Pharmacyclics with IMBRUVICA, you gave a lot of helpful color on how you built up in your model to the peak sales – your end-user peak sales estimate for IMBRUVICA. You sort of broke out by indication, line of therapy, and gave some color on risk adjustment. Do you think you could do the same thing here for Rova-T and the $5 billion number you've put out there in terms of what year do you model peak, are you talking small cell alone, other indications and sort of give some more granular color on how you built up to that number? And then the second question, now that you have purchased Stemcentrx and you've in-licensed the IL-23 from BI, can you give a little bit more color on how you see the R&D line evolving over the next few years? So, specifically, with regard to 2020 guidance, are you going to be able to keep – hold, essentially, the greater than 50% non-GAAP operating margin guidance that you've given previously or should we expect that to have to come down a bit below what you've given? Thank you so much.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, John.
Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. As far as the model, obviously, we went through the model in some level of detail around Pharmacyclics, one, because of the magnitude of the investment that we were making, and we described what supported that investment and how we built up the model. What I characterized for you already basically tells you how we built this model, right? It's built primarily around second- and third-line small cell, which we believe has a very high probability of success. So you can imagine we've risk-adjusted it, accordingly, at a high probability of success. It does have a couple of other smaller indications where we believe there is a very high probability of being able to extend it into some of these other cancers that we described. I wouldn't say that has a significant impact on it, and those are risk-adjusted, accordingly. It doesn't have first-line in it, and the milestone, or the CVR, is basically driven off of what we think the value would be and the return would be appropriate for first-line; and it doesn't have any other of these other milestone-driven POCs that would come forward. So I think that's roughly the same kind of guidance. We gave share and some other kinds of things, and we've obviously built the model around those same kinds of assumptions. But I think, in this case, we'll wait to provide that at a later date once we get closer to a launch of the asset in 2018. On the R&D line – or I think really what you're asking is are we still committed to delivering 50% or greater in 2020? And the short answer to that is, yes. We've looked at it. We've carefully looked at the commitments we've made around the compounded growth rate and the revenue projections as well as the operating margin profile that we communicated last year, and we're still absolutely committed to delivering against that.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks a lot, John. Operator, we have time for one final question, please.
OP
Operator
Operator
Thank you. Our last question comes from Alex Arfaei, BMO Capital Markets. Your line is now open.
AM
Alex Arfaei - BMO Capital Markets
Analyst
Good morning, folks, and thank you for taking the questions. Rick, just following up on some of the earlier questions, the Street has obviously taken a significantly more cautious view relative to your long-term guidance, particularly for HUMIRA. Do you see anything changing in the near future that would allow investors to have more confidence in your long-term guidance? And I guess what I'm asking is, basically, are we going to go through this long drawn out process where we're going from one HUMIRA hearing to another? Or do you see a point where it becomes clear that you can hold off HUMIRA biosimilars in the U.S. for as long as you believe you can? Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: I think there's two ways to look at it. I mean, first of all, if you look at the guidance that we provided back in, I think it was October 29 of last year, and you look at what happened to the consensus numbers, what you'll see is they shifted out roughly a year. I think the mean now is probably – if you look at where people are assuming biosimilar impact in the United States, it's probably in that 2019 – Larry, correct me if I'm wrong here, that 2019 timeframe; so, it moved out from about 2017 to 2019. And I'd say one of the things we track to try to understand how the market is perceiving that guidance is we track what our stock performance has been versus our peers over that period of time. And I saw it just the other day. It may have changed in the last couple of days a little bit, but we're the number one performing stock since that point in time. So I think…
AM
Alex Arfaei - BMO Capital Markets
Analyst
Thank you.
LR
Larry Peepo - Vice President-Investor Relations
Operator
Thanks, Alex. And that concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at abbvieinvestor.com. Thanks, again, for joining us.
OP
Operator
Operator
Once again, that concludes today's conference. Thank you for participating. You may disconnect at this time.