Earnings Labs

AbbVie Inc. (ABBV)

Q2 2016 Earnings Call· Fri, Jul 29, 2016

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Transcript

Operator

Operator

Welcome to the AbbVie Second 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 Liz Shea, Vice President of Investor Relations. Ma'am, you may now begin.

Liz Shea - Head-Investor Relations

Management

Good morning and thank you 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. Before we get started, I want to remind you that some statements made today are or 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 2015 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 turn the call over to Rick. Richard A. Gonzalez - Chairman & Chief Executive Officer: Thank you, Liz. Good morning, everyone, and thank you for joining us today. We delivered another strong quarter with results well ahead of our expectations including adjusted earnings per share of $1.26, representing growth of 16.7% versus the second quarter of 2015. Our results in the quarter included strong top-line performance with global operational sales growth of 18%, reflecting robust growth from…

Liz Shea - Head-Investor Relations

Operator

Thanks, Bill. We'll now open the call for questions. Operator, we'll take the first question.

Operator

Operator

Thank you. The first question comes from the line of Jeff Holford of Jefferies. Sir, Your line now is open.

Jeffrey Holford - Jefferies LLC

Analyst · Jefferies. Sir, Your line now is open

Thanks for that. I'll start with a question for Rick, please. So, Rick, there's clearly substantial trapped value in the company because of the uncertainty for investors around HUMIRA. And you've made positive steps to deal with this through building new growth drivers through R&D, aggressive business development as well as making clear your long-term expectations regarding HUMIRA. Even so, despite great quarters like today, we're still seeing the shares trade at a substantial discount to peers. So, is there anything else that's up for discussion in terms of how you can unlock the trapped value in the company whether it's through different capital allocation, separation of your oncology platform given the valuations they can carry these days or anything else? Second, then for Mike, I wonder what does your collaboration with Bristol on Rova-T tell you about what they are thinking regarding their positioning of their OPDIVO-YERVOY combination in small cell lung cancer? And then last, maybe for Rick again, we're expecting that you'll be in place by Q4 to initiate patent litigation against Amgen. And it will be beyond just the dosing and formulation patents that have been more widely discussed today. Are those still reasonable expectations? And do you think investors will be reassured when we see what other patents Amgen has agreed that they are potentially infringing out of the patent bounds? Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. So, Jeff, this is Rick. I'll cover the first and third one and then I'll have Mike cover the other one. So, on the untrapped value, what I would tell you is that if you look at our PE, I think what you've seen and if you look at the range of companies in our peer group, there are obviously companies that…

Jeffrey Holford - Jefferies LLC

Analyst · Jefferies. Sir, Your line now is open

Thank you.

Liz Shea - Head-Investor Relations

Operator

Thanks, Jeff. Operator, next question please?

Operator

Operator

Next question is from Jami Rubin of Goldman Sachs. Your line now is open. Jami Rubin - Goldman Sachs & Co.: Hi. Can you hear me?

Liz Shea - Head-Investor Relations

Operator

Yes. Jami Rubin - Goldman Sachs & Co.: I assume you can hear me. Anyway, I have a couple of questions. First on the outlook for hep C. Rick, I think you had said earlier obviously VIEKIRA underperformed in the U.S., outperformed internationally. But how are you thinking about the opportunity for next generation hep C given what clearly has been a more challenging pricing environment? And I'm just wondering if you still stand by your $3 billion forecast? And secondly, on Stemcentrx. When do the next two assets for Stemcentrx enter the clinic? Now, is that this year and for which indications? And wondering what we will see potentially at ESMO? And Michael, just maybe if you can explain. I'm still getting a lot of pushback from investors who are unclear about the value of Rova-T just given that the response rate that we saw at ASCO was a bit lower than what we saw at World Lung, I think creating question marks around the durability of response. Thanks very much. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay, Jami. This is Rick. I'll take the hep C question that you had. Certainly, as we said in the first quarter call, we have seen an impact of the new entrant into the marketplace. I'd say we've seen it primarily in the public channels, particularly I'd say the VA, and it really boiled down to a pricing strategy and ultimately we decided that we were not going to match the lowest price, the eight-week price, that was out into the marketplace. And therefore, we lost a significant amount of share. I mean, at our peak, we probably had close to 40% share, and now we have share that's more down in the single-digit range. So, I'd say that's…

Liz Shea - Head-Investor Relations

Operator

Thanks, Jami. Operator, we'll take the next question.

Operator

Operator

Thank you. The next question is from Chris Schott of JPMorgan. Your line now is open.

Chris Schott - JPMorgan Securities LLC

Analyst · JPMorgan. Your line now is open

Great. Thanks very much for the questions. First one is just can you elaborate a little bit more on biosimilar dynamics in Europe? Now that we've had some additional experience with both Remicade and early with Enbrel. Just how are volume and price dynamics shaping up there and the impact to HUMIRA? Second was on HUMIRA and maybe the derm business. It sounds like very strong performance in the quarter. But the environment overall seems to be getting more competitive here with the IL-17 seeing some nice uptake. Are you seeing any impact to the business from these competitors? And just how do you think about the outlook for that part of the franchise over time? Thanks very much. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. Great. Chris, this is Rick. So, I'll cover those. So, let me start with the biosimilar impact because, as you said, we've seen biosimilars certainly with the Remicade biosimilar in the market for quite some time and now we're in the early phases of the launch of Enbrel biosimilars, particularly in the European areas. So, if you look at Remicade, there are Remicade biosimilars now in roughly 60-plus countries, like 62 countries. About 50 of those, a little more than 50 of those, have pricing and reimbursement. So, they are actively involved in marketing the product in those countries. If, we've studied it very carefully, if you look at the overall share of biosimilars it's less than 5%, it's about 4.5%. If you look at their share of Remicade, it's about 20%, 22% something like that. It varies a lot. So, I'd say it's very high in tender based countries like a Norway, Denmark, Poland is an example. Very high market share in those. If you go more into the traditional…

Liz Shea - Head-Investor Relations

Operator

Thanks, Chris. Operator, we'll take the next question.

Operator

Operator

Next question is from Marc Goodman of UBS. Your line now is open.

Marc Goodman - UBS Securities LLC

Analyst · UBS. Your line now is open

Yeah. I was hoping you could give us a flavor for managed care coverage for the key products for 2017, I mean, it's obviously, specifically HUMIRA. And then, could you just give us an update on how you're thinking about AndroGel this days? Thanks. Richard A. Gonzalez - Chairman & Chief Executive Officer: Well, managed care, I mean, we're in really the thick of the negotiations for the 2017 and 2018 timeframe. So, I'm not necessarily going to talk about a lot of specifics because we're in active negotiations on a number of those contracts. But what I would say is HUMIRA has typically had a very, very strong position on managed care and we're not anticipating anything different going forward. But it would be premature to basically talk about a lot of specifics around the contracting, but, I'd say, we feel good about how it is sorting out. On AndroGel, I guess I'm trying to better understand your question. Are you thinking more about follow-on products or are you thinking about the durability of it?

Marc Goodman - UBS Securities LLC

Analyst · UBS. Your line now is open

Yeah. Both. Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: Yeah. Well, we don't necessarily have a follow-on product. We had some programs that we had been working on and that we ultimately decided to stop. And so, it will be running this franchise out. We're treating it as a typical LOE kind of an asset. And it's performing better than what we had expected but ultimately there will come a time where it will suffer more impact from generic competition. And so, we're basically dealing with it as we would deal with most assets, smaller molecule kind of asset LOEs where we take a large part of the cost out of the product. And manage it for maximum profitability. William J. Chase - Chief Financial Officer & Executive Vice President: And Marc, we do continue to see market shrinkage. We've been very pleased with the way that the share has hung in there. And obviously, it's been a nice story this year but we got to watch how this thing plays out as the LOE dynamics proceed.

Liz Shea - Head-Investor Relations

Operator

Thanks, Marc. Operator, we'll take the next question.

Operator

Operator

Next question is Andrew Baum of Citi. Your line now is open.

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst

Thank you. You've obviously done few very substantial deals within the oncology segment with Pharmacyclics and Stemcentrx. Could you just outline what your appetite is and how you see your oncology franchise broadening out over the next few years? Is it now pausing to integrate the two transactions and set up the trial programs that you need? Or is the appetite still there and you see additional opportunities to address other facets of oncology? Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay, Andrew. This is Rick. So, I'll cover that. And maybe Mike can jump in on some specifics. When we went into – when we made the decision that the core future growth franchise on top of immunology was going to be oncology, we made a decision that we would invest in a way to try to build leadership positions in certain areas where we thought we had core competencies that were complementary to being able to perform in those areas. So, specifically, we started with hematological oncology based on the assets that we had internally as well as the opportunity that existed with Pharmacyclics. And our goal was to be basically build a position where we thought we could drive to a leadership position within that category. So, if you look at the assets we have today including IMBRUVICA and where we think VENCLEXTA will be able to expand to, it would tell us that we should have an opportunity to be able to bring forward innovative therapies in roughly 65% of the overall market in hematological malignancies. And I'd say that's an area where we feel comfortable with what we have. Now, having said that, if we found unique opportunities, I'd say particularly in the acute leukemia side, assets or technologies or a drug that…

Andrew S. Baum - Citigroup Global Markets Ltd.

Analyst

Thank you.

Liz Shea - Head-Investor Relations

Operator

Thanks, Andrew. Operator, we'll take the next question please.

Operator

Operator

Next question is from Mark Schoenebaum of Evercore. Your line now is open.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore. Your line now is open

Sorry about that guys. I always have trouble picking up my phone this week. I had a couple of questions. The first is related to Elagolix. There are competitors on the horizon; you're well ahead. There is a drug out there I think from Takeda that's been licensed to be developed in the U.S. and the owners of that drug say it's better than Elagolix because it's QD, once a day, and you can – it's more potent. And most importantly, you can co-formulate it with Add-back. So, I'd love for you to give us your view on Add-back. Is it attractive to have co-formulation or are you guys at a disadvantage or not? And the other question I had was kind of an off the rails question, but I know Henry joined you guys a while back and a lot of people on the Street say great things about him. I'm just wondering will he ever be investor facing? Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: Okay. So, Mark, this is Rick. And I'd say we feel very good about Henry. Specifically, I'll talk myself. Specifically, I feel very good about having Henry as part of the leadership team. And certainly, yeah. I mean, over time I think we will bring Henry in. It will be most relevant when we're talking about those kind of areas where we has direct responsibility for. But Henry has already become an integral part of the leadership team and has contributed significantly. So, Mike, do you want to cover Elagolix? Michael E. Severino - Chief Scientific Officer & Executive VP: Certainly. So, with respect to Elagolix, as you pointed out, Mark, we have a substantial lead, having completed our two pivotal Phase III studies and already being in the…

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore. Your line now is open

Can I say one more thing?

Liz Shea - Head-Investor Relations

Operator

Sure.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore. Your line now is open

Oh, sorry. Yeah. I wasn't sure if I was muted. Hey – and one shout out to Liz, congrats on getting the IR seat. Thanks for all the help. She's doing great.

Liz Shea - Head-Investor Relations

Operator

Thanks, Mark. Operator, we'll take the next question.

Operator

Operator

The next question is from Vamil Divan of Credit Suisse. Your line now is open. Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker): Great. Thanks so much for taking the question. So, maybe two. You touched on this a little bit at your R&D day, but just around multiple myeloma and some of the work you guys are doing there and you touched a little bit on VENCLEXTA and moving that one in there. A little bit more just thoughts around that given such a competitive space and what you see as the advantages of moving into there. And then, the other one which you didn't touch much on at the R&D day and I think it's overlooked a little bit is veliparib and there's been a lot of discussions around the PARPs recently. Just curious if you can kind of maybe refresh us on sort of what you feel is the competitive advantages that you may hold or where that's going to sort of fit in relative to the other PARPs that are either on the market or in development? Thanks. Michael E. Severino - Chief Scientific Officer & Executive VP: Okay. So, the first part of the question related to multiple myeloma and we have the potential to pursue myeloma with a number of assets in our portfolio. VENCLEXTA has clear potential there and we're advancing that program rapidly as we mentioned during our opening remarks. IMBRUVICA also has potential, as do a number of the molecules in our pipeline. It is a competitive space. One can prolong survival to a much greater extent today than was possible a decade ago. But we still don't have curative therapies. Patients ultimately fail therapy and progress which means that we need new mechanisms that aren't cross-reactive that provide…

Liz Shea - Head-Investor Relations

Operator

Thanks, Vamil. Operator, we'll take the next question, please.

Operator

Operator

Next question is from the David Risinger, Morgan Stanley. Your line now is open. David R. Risinger - Morgan Stanley & Co. LLC: Thanks very much. I have two questions. First, with respect to payers, they are starting to talk about trying to contract for individual indications. And obviously, one area they might be thinking about is alternatives to HUMIRA for certain indications from new drugs that have potentially better profiles than HUMIRA in certain indications. Could you just comment on your perspective on contracting for individual indications in autoimmune disease? And then, second, Rick, I was hoping that you could provide a little bit more detail on the sort of timing and specifics surrounding the patent litigation steps? So, obviously, you're not going to comment on individual patents or individual patent strategies. But as I understand it, there will be immediately after Amgen gets approval of its biosimilar, immediately after that occurs, there will be a wave of patent litigation that kicks in and I was just hoping that you could provide a little bit more perspective on how investors should think about that, and what they should be expecting? Thank you. Richard A. Gonzalez - Chairman & Chief Executive Officer: Yeah. So, this is Rick. So, let me start with the payer question that you had. Indication-based pricing, I think, first evolved primarily in the oncology space. And it was driven, I think, by certain efforts to say, you'll have an oncology agent that has very strong efficacy in a certain disease, and might have significantly lower efficacy in another disease, and why would I pay the same for this strong efficacy as I would for relatively modest efficacy? I think that was how the concept originally evolved. As we look at HUMIRA, and we look across all of the major indications at least, with every single indication, there's obviously some variation between the competitive profiles. But I'd say, in general, HUMIRA tends to perform across those broad set of indications in the top tier. And so that is how we view it. So, indication-based pricing wouldn't be something that we think is very applicable for this specific asset in this particular class. And we haven't seen it take off much prior to this, and we'll have to see how it plays out over time. There are a lot, it may sound to you like it's a fairly innocent issue around timing and the steps and what should play out, but I would tell you, it's not that from a litigation standpoint. And so I'm just going to need to take the same position I did before. We're not in a position to be able to give you a lot more color. Certainly, we've made it clear what our position is going to be. And I think that will become clearer as the steps play out. But I can't give you a whole lot of color on the timing or what the alternatives would be.

Liz Shea - Head-Investor Relations

Operator

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

Liz Shea - Head-Investor Relations

Operator

Operator, we have time for one last question.

Operator

Operator

Okay. The last question is from Gregg Gilbert of Deutsche Bank. Your line now is open.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Your line now is open

Thanks. I want to go back to Bill's comments on HUMIRA growth in the beginning. Clearly, prescription growth has been very robust. But you're also enjoying a really nice pricing tailwind. And I think the net price benefit you saw in the U.S. was about 10% which required, I think, a 20%-plus lift price increase over the year-ago period. So, I'm curious how you would expect that dynamic to play out, both list price increased magnitude and frequency going forward, the ability to realize net price and how you're thinking about that? Seems like a very robust high set of numbers for such a big product. And lastly, Bill, since we don't have a 10-Q, perhaps you could provide cash flow from ops and receivables if you have those handy, would appreciate that. Thank you. William J. Chase - Chief Financial Officer & Executive Vice President: Sure. Gregg, I think probably the best thing to do is dissect the U.S. number on the quarter for you. And I think that will give you a good sense of the overall dynamics of the brand. And then I'll back up and talk a little bit about the business in general. Obviously, the brand is performing very, very well in the U.S. We grew at 26.7% in the Q. Script trends, the way we see them, we're in the mid-teens for the quarter. Our price was up – it was actually up in the single digits. And then, as I said in my comments, we did see a modest impact from differences in customer order patterns. Again, we run this business at less than half-a-month inventory. But it gets a little tough to call at various times and we did see a little bit of demand differences between the Q. We had a…

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Your line now is open

Thank you.

Liz Shea - Head-Investor Relations

Operator

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

Operator

Operator

Thank you, speakers. And that concludes today's conference call. Thank you, all, for joining. You may now disconnect.