Earnings Labs

AbbVie Inc. (ABBV)

Q3 2017 Earnings Call· Fri, Oct 27, 2017

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Transcript

Operator

Operator

Good morning and thank you all for holding. Welcome to the AbbVie third quarter 2017 earnings conference call. All participants will be able to listen only until the question-and-answer portion of this call. I would like to remind all parties today's call is being recorded. If you have any objections, please disconnect at this time. I would now like to introduce Ms. Liz Shea, Vice President of Investor Relations.

Elizabeth Shea - AbbVie, Inc.

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 remind you that some statements that we make today are or 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 2016 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. In addition to the news release issued this morning, we have also posted slides on our website at investors.abbvie.com that supplement some of the content we'll be covering this morning. Following our prepared remarks, we'll take your questions. So now with that, I'll now turn the call over to Rick.

Richard A. Gonzalez - AbbVie, Inc.

Management

Thank you, Liz. Good morning, everyone, and thank you for joining us this morning. Today, we'll be covering two topics. I'll briefly discuss our third quarter performance and operational highlights, and Mike and Bill will walk you through the quarter in more detail. Then, I'll provide an update on the company's long-term strategic and financial objectives. And as always, we'll provide ample time at the end of the call to answer your questions. We delivered another quarter of outstanding performance, with results ahead of our expectations. Adjusted earnings per share were $1.41, up 16.5% versus last year. We also delivered strong top line results in the quarter with operational sales growth of 8.8%, driven by a number of products in our portfolio. This includes HUMIRA, with global operational sales growth of nearly 15%, and IMBRUVICA, which grew more than 37% versus the prior year. Based on our strong year-to-date performance, we are raising our full-year 2017 EPS guidance to $5.53 to $5.55, reflecting growth of 14.9% at the midpoint. During the quarter, we announced the global resolution of all intellectual property-related litigation with Amgen over their biosimilar to HUMIRA. We're pleased with this settlement, which we believe demonstrates the strength of our HUMIRA IP portfolio and further demonstrates our confidence that we will not see direct biosimilar competition in the U.S. until at least the 2022 timeframe. Importantly, this will allow a number of key assets within our robust late-stage pipeline to enter the marketplace and establish a strong growth trajectory. Mike will provide additional color around recent advancements across numerous pipeline programs, but I'll briefly mention a few highlights. We're very pleased with the significant progress we've made with several late-stage assets. In particular, the data readouts for upadacitinib and risankizumab illustrate that both of these therapies have the…

Michael E. Severino, M.D. - AbbVie, Inc.

Management

Thank you, Rick. In order to allow time for our strategic update, I'll keep my prepared remarks brief, highlighting just a few of the noteworthy milestones from the quarter. As Rick mentioned, we've continued to make significant progress across our pipeline. In immunology, we reported results from several mid and late-stage trials. Just yesterday, we announced positive top line results from three Phase III studies evaluating risankizumab in psoriasis. Data from these trials demonstrated superior skin clearance with risankizumab treatment versus two leading biologics, Stelara and HUMIRA. In the ultIMMa-1 and ultIMMa-2 trials, 75% of patients receiving risankizumab in both studies achieved PASI 90 compared to 42% and 48% of patients receiving Stelara, respectively. We are particularly encouraged by the durable rates of skin clearance demonstrated in these two studies. At one year, roughly twice as many patients treated with risankizumab achieved full skin clearance compared to Stelara, with 56% and 60% of the risankizumab patients achieving PASI 100 in ultIMMa-1 and ultIMMa-2 respectively. We also saw very high rates of efficacy in the IMMvent study, with risankizumab demonstrating superior rates of skin clearance compared to HUMIRA. Within this trial, we designed a portion of the study to evaluate risankizumab's efficacy in patients who had an inadequate response to HUMIRA. In this portion of the study, patients with an inadequate response to HUMIRA after 16 weeks were re-randomized to risankizumab or HUMIRA. And, of these patients, 66% treated with risankizumab achieved PASI 90, compared to 21% who continued with HUMIRA, demonstrating risankizumab's potential in the growing TNF inadequate responder population. We look forward to seeing data next year from the remaining trial in the psoriasis pivotal program. Our regulatory submission is on track for 2018, with commercialization expected in 2019. Moving now to upadacitinib, our oral selective JAK1 inhibitor, in…

William J. Chase - AbbVie, Inc.

Management

Thanks, Mike. We are very pleased with our strong third quarter results. Total net revenues were nearly $7 billion, up 8.8% operationally excluding a 70 basis point favorable impact from foreign exchange. We reported adjusted earnings per share of $1.41, up 16.5% compared with the third quarter of 2016. Adjusted EPS exceeded the midpoint of our prior guidance range by $0.04 due to favorable sales and operating margin profile dynamics. There was also a $0.02 benefit in the quarter related to the divestiture of an equity position. HUMIRA's global sales in the quarter were $4.7 billion, up 14.8% operationally, reflecting continued strong demand. U.S. growth was 19.1%, driven by prescription growth approaching 12% and mid-single-digit price contribution. The growth rate versus 2016 also reflected some benefit from customer ordering patterns in the third quarter of 2016. Wholesaler inventory levels were below 0.5 month in all quarters. International HUMIRA sales were $1.6 billion in the quarter, up 6.8% on an operational basis. With its unique product profile, years of physician experience, and broad set of indications, HUMIRA remains the undisputed market leader across all therapeutic categories despite competition. Global IMBRUVICA net revenues in the third quarter were $688 million, up more than 37% versus the prior year. IMBRUVICA continues to drive strong uptake in front-line CLL and remains the market share leader in CLL across all lines of therapy, with total patient market share of 35% in first-line and over 70% in the second-line-plus setting. Global HCV sales in the third quarter were $276 million. During the quarter we received regulatory approval for MAVYRET, our next-generation HCV offering in the U.S., Europe, and Japan. While we are still in the early stages of our launch, we've been pleased with its initial uptake globally, and physician feedback on the product has been…

Richard A. Gonzalez - AbbVie, Inc.

Management

All right. Thank you, Bill. I'll apologize in advance. This section is fairly long. As a reminder, we have posted a slide presentation to our website. These slides are intended to be a supplemental resource for today's call. However, my prepared remarks will not directly follow these slides. When we launched AbbVie in the beginning of 2013, our objective was to build a high-performing biopharmaceutical company capable of delivering top-tier financial performance over the long term. The actions we've taken over the last five years have been designed to support just that objective. Along the way, we have consistently communicated our objectives, sharing with investors how we intend to execute on our strategy and how we're tracking against our goals as a company. And over the last five years, we have consistently delivered a top-tier financial performance, demonstrating that we have created an organization that is capable of executing at a very high level. We've also consistently shown our ability to overcome obstacles and challenges while still meeting or exceeding our commitments. As we look back and we evaluate our performance versus our peer group of 11 companies over the last five years, whether measuring our performance over the past year, past two years, three years, four years, or launch to date, we're pleased that AbbVie has performed first or second in total shareholder return and revenue growth and EPS growth in nearly every one of those periods. We have met or exceeded our EPS guidance in all 19 quarters since becoming a public company, exceeding our guidance in 16 quarters. Additionally, we have acted boldly to build a robust pipeline that will sustain growth over the long term. AbbVie simply isn't the same company it was in January of 2013, and we have delivered exceptional shareholder return over this…

Elizabeth Shea - AbbVie, Inc.

Operator

Thanks, Rick. We'll now open the call for questions. Operator, first question please.

Operator

Operator

Our first question today is from Jeff Holford from Jefferies.

Jeffrey Holford - Jefferies LLC

Analyst · Jefferies

Hi, everyone. Thanks very much for taking my questions. I've got a few quick ones for you. Just first off, there seemed to be a lot of focus yesterday around one of your competitor's commentary around the sudden decline or deterioration in the growth of the psoriasis and psoriatic arthritis markets. I'm not sure that we've seen it in some of the other companies reporting. I just wondered if you'd like to comment on what you see the market growth there. Second, I know you're not going to give the rate based on what you said. But can you just confirm that upadacitinib you're seeing a rate below 0.8, which is I think is what one of your other competitors referred to as the upper end of the background rate that's out there? Then just on hep C, you say in your slide deck you're trending below the $3 billion for 2020, which obviously is right based on the current numbers, but MAVYRET looks to be having a very impressive early launch. I know that we won't be through contracting until through 2018, and 2019 is probably the year that it really steps up. But are you not perhaps a little bit more confident than you indicated in the slide deck that you could be around $3 billion at least by 2020? And then just last on elagolix, I note the Priority Review. That's really interesting, particularly in light of the opioid use that's there. I'm just wondering what kind of additional labeling support or just what you're looking for there to be able to make the case that this could be part of the solution to the opioid epidemic, particularly in those women with endometriosis. Thanks very much.

Richard A. Gonzalez - AbbVie, Inc.

Management

Okay. Mike, maybe why don't you start by talking about the rate, and then I'll cover the other three?

Michael E. Severino, M.D. - AbbVie, Inc.

Management

Certainly. So on upadacitinib, what we've said is that we monitor the program very carefully, and we look at the aggregate data. And so when we monitor the data at this stage, we're looking in a blinded manner across our entire database. And it's important to understand that because I can't give you a rate that is a upadacitinib rate today without talking about unblinded data and ongoing studies, and I can't do that. So what I'll do is I'll talk about aggregate rates. And what we said and what remains true is that those aggregate rates are consistent with the background. And we've said that the background, there's variability in that background, but those estimates are around 0.8. And so that hasn't changed. It also hasn't changed that we haven't seen anything that we consider a signal. And the aggregate of our monitoring program tells us that all the statements that we've made are still holding.

Richard A. Gonzalez - AbbVie, Inc.

Management

Okay, so let me talk a little bit about the psoriasis market first. I think what is being confused here is the slowdown in our product versus the slowdown in our market, and we had something similar happen roughly a year ago with a different product. If you think about when OTEZLA entered the market, it really drove a number of patients, particularly the more mild patients into the market. And if you recall correctly, we saw the psoriasis market rate grow very rapidly over that period of time, the market rate. And essentially, what we're seeing now is that that product is no longer gaining traction. And therefore, that group of patients and that growth is no longer in the market. But if you strip that out, which is what we do all the time to look at our performance, because we really compete in more of the moderate patient population where the biologics tend to compete, moderate to severe, that rate has stayed the same or accelerated. In fact, it's actually accelerated a bit because you'll have patients that don't get adequate response on OTEZLA that then move on to a biologic. And psoriasis is one of the fastest-growing segments we operate in, mid-teens growth rate. It's a very robust market. It's a highly attractive market. We perform extremely well within that market. And so I'd say our point of view is very different, and I think our performance clearly demonstrates that it supports our point of view as being different. So I think it's not a question of the market, it's a question of the performance of that asset and what it drove into the marketplace. On your third question, which was HCV greater than $3 billion, look, we're certainly tracking below $3 billion today. MAVYRET is…

Elizabeth Shea - AbbVie, Inc.

Operator

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

Jeffrey Holford - Jefferies LLC

Analyst · Jefferies

Thanks very much.

Operator

Operator

Thank you. Our next question is from Jami Rubin from Goldman Sachs. Jami Rubin - Goldman Sachs & Co. LLC: Thank you. Rick, you provided a ton of information in your strategic update, and I'm sure you're tired of talking, but I have a really, really simple question for you. Do you see a cliff at all? And if not, can you grow the company through whatever cliff you might see or some erosion from HUMIRA? And I ask the question because, obviously, the stock has had a big move. But my sense is that if you look at the multiple, as you correctly pointed out, it is still at the bottom third, reflecting my sense is that investors still view that there is a cliff coming, albeit pushed out. So is that the right way to look at it, or do you think this is a company without a cliff and a company that can actually even grow through that cliff? Thanks.

Richard A. Gonzalez - AbbVie, Inc.

Management

Jami, if you look at our objective when we launched the company, we knew from day one that there was a point of time when we would be dealing with biosimilar competition on HUMIRA. And our whole focus on building a pipeline, a robust pipeline, was designed to allow us to be able to grow through that period. And we talked over and over again about the importance of the 2019 date in order to launch those products and ultimately be able to drive them up the growth curve to the point where they are profitable and they are contributing significantly. And I think as we continue to advance, we are hitting all of those milestones that we set for ourselves to be able to do that. And so I would tell you that our whole intent was to be able to drive through that erosion curve that we expected. I'd also say that as we watch biosimilars play out, mostly in the international markets is where we've seen most of the experience. They are operating in a way and the counter-strategies that the innovators are using are operating in a way that is consistent with our model that we will use, and we'll actually start that model in 2018 in markets that are going to see at the end of 2018 biosimilar competition outside the U.S. We're seeing erosion that is consistent with what we assume. And I think we will be able to deal with that in a way that is effective. And so I would say could you have some lumpiness at certain points? I think you could. Do I think will we be able to grow through it on an extended basis? I don't think there's any question that we'll be able to grow through it. Jami Rubin - Goldman Sachs & Co. LLC: Thank you.

Elizabeth Shea - AbbVie, Inc.

Operator

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

Operator

Operator

Thank you. Our next question is from Josh Schimmer from Evercore ISI Group.

Joshua Schimmer - Evercore ISI

Analyst · Evercore ISI Group

Great, thanks for taking the question, two of them quickly. Can you provide an update for how the managed care contract negotiations have gone for HUMIRA and the rest of the portfolio as you approach 2018 and then have greater visibility into 2019? And then maybe a question for Mike, as you think about allocation of R&D spending to the Stemcentrx portfolio, can you discuss what percent of the R&D budget do you think those assets will eventually consume? And do you have any plans to assess other targeting technologies beyond the ADC approach that you're currently using? Thanks.

Richard A. Gonzalez - AbbVie, Inc.

Management

On the managed care contracting, so we're through all the contracting for managed care and PBMs for 2018. HUMIRA has over 95% preferred covered lives coverage, so we're very pleased with our overall coverage range. And so I don't know specifically how many of those bridge into 2019, so I don't have that data available. But there was one change, and that was in Aetna, where Aetna did change our status for new patients. We've maintained existing patients, but Aetna is not a large number of covered lives, so that doesn't have any material impact on the brand or on the company, obviously. But as I said, we have a little over 95% preferred access, which is clearly where we want to be.

Michael E. Severino, M.D. - AbbVie, Inc.

Management

Okay, and so this is Mike. I'll take the question about Stemcentrx and our overall portfolio. So as we mentioned on the call, we have a very robust portfolio overall in R&D. And certainly within oncology, we are building considerable momentum. As I mentioned, we have 20 programs in the clinic, 17 of those are in early development. And that's a mix between Stemcentrx and other AbbVie programs. And so that makes it difficult to give you a percentage that Stemcentrx will represent going forward because, of course, that's going to be based on the total number of programs that advance into later-stage development. What I would say is we're seeing encouraging signs across that portfolio, on stem programs and other programs of activity, so we'd expect to advance a number of those programs. And with respect to your question about targeting technologies, we certainly have a number of ADCs in our portfolio. We feel that the talents we have as an organization fit that very well in terms of our skills in small molecule chemistry and protein engineering and antibody engineering, but we are in no way limited to ADCs. We have very robust capabilities in small molecules, in novel biologics beyond monoclonal antibodies. We have a presence now in oncolytic viruses and other novel means to modulate targets. And so we're going to look at the targets that we have available, and we're going to pick the best modality that we can to address them, and that is in no way going to be limited to ADCs.

Joshua Schimmer - Evercore ISI

Analyst · Evercore ISI Group

Great, thank you.

Elizabeth Shea - AbbVie, Inc.

Operator

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

Operator

Operator

Thank you. Our next question is from Chris Schott from JPMorgan.

Christopher Schott - JPMorgan Securities LLC

Analyst · JPMorgan

Great, thanks very much, and appreciate all the commentary earlier on the call. Maybe the first question is for Rick. It's just expanding on some of those earlier psoriasis comments you made and just thinking about that business going forward. You obviously have a significant position here with HUMIRA, but there's a number of very effective agents, including your own IL-23, either launching or about to launch. So can you just elaborate a little bit more on, A), how much more room do you see for biologic shares to increase here? Maybe B), how do you see TNF's positioning versus these newer agents? And then C), on the pricing dynamics side, does this lead to an area where there could be more price competition, given all the options patients have? And then my second question is on capital deployment priorities. Just given all the traction you've had on the pipeline, can you just update us a little bit about how you're thinking about capital deployment on a go-forward basis? Thank you.

Richard A. Gonzalez - AbbVie, Inc.

Management

Okay. So I think if you look at the psoriasis business – and I'd say in general, if you look at all of the areas where HUMIRA competes, it has been and continues to be a relatively crowded market. That hasn't changed the performance of HUMIRA, and I don't expect it to change going forward either. Certainly, there are room in this market for significant additional biologic penetration. In fact, if you look at the psoriasis market, it has the lowest biologic penetration rates of the three major segments – rheum, GI, and derm. Derm is the lowest of the three, so it certainly has the greatest opportunity to be able to drive additional biologic penetration. And there clearly is an opportunity to have differentiated products within that segment where you have very, very high efficacy products, like our IL-23, that fit in a portfolio with products like HUMIRA. And in fact, as we look at our positioning within that market, that is how we think about it. We think about HUMIRA will still be a workhorse product within that market, and risankizumab will fit in for where physicians have patients that ultimately want a higher level of efficacy, and it clearly has a very durable response. I think the perception is in derm that over time you see a waning effect of these drugs. And in fact, if we look at the risankizumab data, what we see is just the opposite. As we go out in time, the response becomes more robust. And in fact, if you look at total clearance, it's 60% I think at 12 months, which is very impressive. We haven't seen an agent that looks like that. Convenience of dosing is going to be another significant thing. There will be patients who prefer a less…

Elizabeth Shea - AbbVie, Inc.

Operator

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

Operator

Operator

Thank you. Your next question is from Geoff Meacham from Barclays.

Evan Seigerman - Barclays Capital, Inc.

Analyst · Barclays

Hi all, this is Evan on for Geoff. Congrats on all the progress, and thank you for some of the longer-term guidance and insights, and one quick thank you to Liz and her team for the great strategic slides. They're very, very helpful. One on hep C. Given the evolving commercial landscape for hep C, what are some of your lessons learned on pricing and reimbursement? And then I have a follow-up on Rova-T.

Richard A. Gonzalez - AbbVie, Inc.

Management

Well, I don't know that I would describe them as lessons learned. I think as we indicated when we launched MAVYRET, one of the things that we look carefully at is what segment of the U.S. market would be available for this asset and what was the right go-to-market strategy to be able to access that, because we certainly viewed that as the early opportunity. And then obviously, we drove our decision to come out with a WAC that was in the price range that we came out with it. So whether you call that a lesson learned or you just say that basically in our analysis of how to be successful in this segment of the market, that was the strategy we came up with. I think you can look at it either way. Certainly, I think as we look back at that decision, that was a good decision that clearly has had the impact that we had hoped it would have. And I think in general, we like stability in this market. Certainly, this is a market that has had significant price erosion over the last several years. Most of our contracting is positioned in a parity fashion, and we're totally comfortable with that. In fact, that's our preferred position because we believe this asset can compete effectively, quite effectively, on the attributes of the asset itself. And I think that is the positioning that we're using in the marketplace, and it's been effective.

Evan Seigerman - Barclays Capital, Inc.

Analyst · Barclays

That's great. And then on Rova-T, how has the bar changed in small-cell lung cancer, given there being other novel treatment approaches and now that you've pushed the data out, what is it, a quarter or two?

Michael E. Severino, M.D. - AbbVie, Inc.

Management

So small-cell lung cancer remains an area of very, very substantial unmet medical need. The standard of care hasn't changed in many years. And we view it in a positive way overall that there are now some therapies that look like they can make a real difference here, Rova-T included. I'm not sure that the bar has changed substantially though. So for example, if you look at third-line or greater small-cell lung cancer, there are no approved therapies. Response rates based on expert opinion, because there really are no good clinical studies here, would probably be in the low single-digit range, if not zero. And survival is dismal. And as Rick mentioned, with recent I-O releases, objective response rates of 10% or 20% are meaningfully different from that. And so there's a huge unmet medical need here, and there's an unmet medical need that relates not only to response rates but also to getting patients on a course that allows them to have good long-term outcomes. And those longer-term outcomes have been a strength of Rova-T based on its stem cell-targeting approach, cancer stem cell-targeting approach. So while there are encouraging signs, there's still a huge unmet medical need, and I don't think the bar has changed substantially.

Evan Seigerman - Barclays Capital, Inc.

Analyst · Barclays

Great, thanks for the questions.

Elizabeth Shea - AbbVie, Inc.

Operator

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

Operator

Operator

Thank you. Our next question is from Steve Scala from Cowen.

Steve Scala - Cowen and Co. LLC

Analyst · Cowen

Many thanks. I have two questions, first a question on the settlement with Amgen on the HUMIRA IP. Settlements of this nature almost always include language allowing the challenger, obviously in this case Amgen, to launch earlier under certain circumstances. And one such circumstance might be another company's at-risk launch, and in this case, earlier than January of 2023, at least in the U.S. Such language was not in the AbbVie release, and I think it would be material information. So I'm wondering why an earlier launch by Amgen appears to not even be possible under any circumstances? And secondly, can you be more specific on what RA studies will support the ABT-494 filing? Will it be all six or some subset of them? Many thanks.

Richard A. Gonzalez - AbbVie, Inc.

Management

Okay, I'll handle the Amgen settlement piece. We have an agreement with Amgen that we have not released all of the specifics around the contract between us and Amgen, and I'm certainly not going to do that now. What I would tell you is this. What gives us confidence that we're not going to have earlier launches? Let's disconnect it from whether or not Amgen would be able to go to the market or not, is the fact that, one, we believe this clearly demonstrates the power of our IP. Number two, we've been very clear about our position and how we'll enforce our IP. And if necessary, we will attempt to get a preliminary injunction to block anyone that launches if they violate our IP. I think if you look at the rulings that have come out of the patent office around the formulation patents alone, I would say that would be an extremely compelling argument with the court in order to obtain a preliminary injunction against someone. And I think the precedents would suggest that it would be unlikely that the court wouldn't follow what the patent office had described as they reviewed those patents and reaffirmed those patents against the challengers. And so I think what gives us confidence is we fundamentally believe, one, that's an incredibly risky strategy for someone to take based on the size of this asset and the damage that would be done and the consequences of that damage if they lost. Number two, I don't know that I can be any clearer about what our intent is, but I think they understand what our intent would be to defend it. And number three, I think our probability of success of getting a PI is high.

Michael E. Severino, M.D. - AbbVie, Inc.

Management

Okay, so this is Mike. With respect to the RA studies for upadacitinib and what will support an NDA next year, as you mentioned, we have six studies, and those cover a range of patients from methotrexate inadequate responders to biologic inadequate responders. They include active comparator studies and studies aimed to look at structural endpoints. And so we will file with at least five studies of the six. We've always considered five studies our core. There was a sixth study, which is a structural study, which was originally anticipated to take longer than the others, but it is moving forward ahead of schedule. So it's possible that that could actually come in at a time that it can be included, but we're going to continue to evaluate that, but it would either be five or six studies that we would include.

Steve Scala - Cowen and Co. LLC

Analyst · Cowen

Thank you.

Elizabeth Shea - AbbVie, Inc.

Operator

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

Operator

Operator

Thank you. Our next question is from Geoffrey Porges from Leerink.

Geoffrey C. Porges - Leerink Partners LLC

Analyst · Leerink

Thank you very much and thanks for all the background color, first question for Mike. Mike, you've talked about upadacitinib in your observations. But could you just give us a sense of – we can't help this question of the BTE rate given what's happened with other programs. So could you give us a sense of the total clinical experience in RA and the number of observed events so far in the RA studies? I know that the studies are still blinded or some of them are, but it will be helpful to know where you stand. And then could you just comment on whether you're seeing any platelet increases or decreases? And then on a related note, I'm struck by the timing of the launches of upadacitinib and risankizumab in ulcerative colitis and Crohn's, which are out in 2022 and 2023. Is there a bottleneck in study sites or in patient recruitment? Because it just seems a long time to have to wait for those programs in IBD to mature. If you could, help us understand that. Thanks.

Michael E. Severino, M.D. - AbbVie, Inc.

Management

Certainly. So with respect to rates across the program, I think the best answer that I can give you is the answer that I gave you in my prepared remarks, which is that we monitor the program in aggregate across all of the studies. And of course, we're still blinded on the majority of the studies and therefore the majority of our database. And when we look at that and when we look at those rates, those rates are consistent with the background rate that we've stated on a number of occasions. We're going to continue to monitor carefully, but we do not see that situation change. I'll also refer to the remarks I made about our DMC. We are firewalled from our DMC by design, but our DMC has access to all of the data, including the unblinded data, and they have consistently recommended that we continue the program without any modifications. And if they had concerns, you certainly wouldn't expect that to have been their course of action. With respect to platelet changes, we've looked at it. We've not seen any changes with platelets. Platelets remain stable on therapy. And I think platelets don't seem to be playing any part of the picture for upadacitinib. In terms of launches in UC and Crohn's, it's early on in those programs. So we're always going to try to move as quickly as we can and advance programs rapidly, but we're not seeing any bottlenecks in sites. We're not seeing any bottlenecks in patients. In fact, recruitment across the program has gone very well, I think indicative of strong investigator and patient interest in the upadacitinib program broadly.

Geoffrey C. Porges - Leerink Partners LLC

Analyst · Leerink

Thanks.

Elizabeth Shea - AbbVie, Inc.

Operator

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

Operator

Operator

Thank you. Our next question is from Vamil Divan from Credit Suisse. Vamil K. Divan - Credit Suisse Securities (USA) LLC: Great, thanks so much for taking my questions and also for all the details today. So a couple thoughts around the long-term plan and just maybe some updates to your thoughts when you made the plan in 2015 and the update today. So specifically around HUMIRA, and if you can, just what your assumptions are on pricing growth in the U.S. for that product between now and 2020, what's baked into that $21 billion number? Second, HUMIRA in terms of the EU biosimilar impact, obviously it still looks like it's end of next year. Just what your thoughts are, we have a little more experience now with biosimilars, in fact, than when we did two years ago, so what you guys are assuming the impact will be on HUMIRA in Europe starting I guess in 2019? And then finally, just around once we do see U.S. biosimilar direct competition, it sounds like in January 2023, is there any change to your outlook on the rate of erosion at that point, maybe just with some of the changing pricing dynamics or payer dynamics in this country, or do you feel pretty much the same about the erosion curve after 2023? Thanks so much.

Richard A. Gonzalez - AbbVie, Inc.

Management

Okay, Vamil, this is Rick. So HUMIRA pricing was your first question as it relates the long-term guidance. I think obviously, we do a long-range plan. What you're seeing is the result of what comes out of that long-range planning process. That's where these numbers obviously come from. And we have communicated previously I think to the investment community that our typical strategy is that we are conservative particularly on the out years because it's much harder to predict from a pricing standpoint, so we tend to be relatively conservative on those out years. We evaluate it as we get close to the coming year what we think the dynamics are. We have recently come out and said that in 2018, we'll have one price increase, similar to what we did in 2017. And that price increase, I can't remember the specific language. Bill probably can. But it basically said that it would be below double-digit, and that is how we plan on operating in 2018. And so I think it's consistent with all of that. As far as biosimilars outside of the U.S., we've obviously spent a lot of time studying both the Remicade biosimilar, which has been out there for a longer period of time, the Enbrel biosimilar. We're watching the Remicade biosimilar here in the U.S. as well. And we've modeled both our strategy and our expected erosion curves against the experience that we've seen there and the competitive response that we've seen and the effectiveness of that competitive response. We've communicated as part of the previous long-range planning guidance that we gave, is that what we expect is for the brand internationally to peak at in 2018 and then start a modest erosion curve as we see biosimilars enter the marketplaces outside the U.S. in the…

Elizabeth Shea - AbbVie, Inc.

Operator

Thanks, Vamil. We've got now almost 90 minutes, so we got only time for one more question. Obviously, after the call, we'll be available to answer and address any additional questions that we're unable to get to in the queue today. So, operator, we'll take the last question.

Operator

Operator

Thank you. Our final question today is from Gregg Gilbert from Deutsche Bank.

Gregory D. Fraser - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank

Thank you. It's Greg Fraser on for Gregg Gilbert. On elagolix, how are you thinking about the size of opportunity for endometriosis versus uterine fibroids? And how do you see your current new product business being impacted as adoption of elagolix grows? And then a quick one on VENCLEXTA, how should we think about the market opportunity with a broader label based on the MURANO data? Thank you.

Richard A. Gonzalez - AbbVie, Inc.

Management

If you look at elagolix in endometriosis, that deck that we provided you will give you the specific numbers, but I'll do this from recall. There are approximately about 2.5 million women in the U.S. that are diagnosed. We think that undiagnosed is probably in the range of about 4 million women. So obviously, it's a big opportunity, and it's the earlier opportunity. Now, there are more patients who have uterine fibroids, but uterine fibroids are behind endometriosis. And so clearly, we think this is so multibillion-dollar opportunity in endometriosis. It is one that will require education because this is an area where there hasn't been any real new therapies in this market for 10 years or so. So it is going to require both patient education as well as physician education. And so it will have a ramp that is consistent with the kinds of assets that require that kind of market development. And we're going to start that market development from a disease awareness standpoint prior to the approval of the drug. So we'll be starting that in 2018 to start to prepare the market for the launch of elagolix. But I think it's a very significant opportunity, and it's one we're obviously preparing for a high-level success. As far LUPRON is concerned because of the side effect profile of LUPRON, LUPRON is incredibly effective at this. The problem is that it completely shuts down the access, and so it has all of the implications of essentially putting the patient into menopause. And so it's not a very desirable drug to use for this particular indication, and therefore the sales for this area are relatively modest. So it won't have a material impact at all. My guess is it will have significant erosion of the little bit that it has, but that won't have any kind of material impact overall. And on MURANO, obviously, today we have a label that's essentially for 17p deletion, which is a relatively – it's an important segment of the market for those patients because they have difficult outcomes, but it's a relatively small number of patients. The broader relapsed/refractory indication in CLL is a very significant opportunity. So this will drive – once we have this in the marketplace, we would expect that this will drive significant revenue ramping of VENCLEXTA.

Elizabeth Shea - AbbVie, Inc.

Operator

Thanks, everyone. That concludes today's conference call. You could access a replay of the call at our website. Thanks again for joining us.

Operator

Operator

Thank you. And this does conclude today's conference. You may disconnect at this time.