Earnings Labs

Biogen Inc. (BIIB)

Q2 2016 Earnings Call· Thu, Jul 21, 2016

$193.87

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Transcript

Operator

Operator

Good morning. My name is Dan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen second quarter 2016 financial results and business update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I now would like to turn the call over to Mr. Matt Calistri, Senior Director of Investor Relations. Please go ahead.

Matthew Calistri - Senior Director-Investor Relations

Management

Thanks, Dan. Thank you, everyone, and welcome to Biogen's second quarter 2016 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of biogen.com to find the press release and related financial tables, including a reconciliation of the GAAP-to-non-GAAP financial measures that we'll discuss today. Our GAAP financials are provided in tables 1 and 2. Table 3 includes a reconciliation of our GAAP-to-non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted slides on our website that follow the discussions related to this call. I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult our SEC filings for additional detail. On today's call, I'm joined by our Chief Executive Officer, Dr. George Scangos; Dr. Michael Ehlers, EVP of Research and Development; our Chief Commercial Officer, Michel Vounatsos; and our CFO, Paul Clancy. We'll also be joined for the Q&A portion of the call by our Chief Medical Officer, Dr. Al Sandrock. Now I'll turn the call over to George.

George A. Scangos - Chief Executive Officer

Management

Okay. Thank you, Matt, and good morning, everyone. Thanks for joining us. I'd like to begin with a personal statement. I'll be stepping down as CEO of Biogen sometime within the next few months. The board and I recognize that this is an excellent time for a transition. The company's doing well now. The management team is complete and extremely capable, the commercial and R&D activities are going well, and we're on our way to adding to the pipeline through internal and external opportunities. It's a good time for a new CEO to take the helm and see Biogen through to what I believe is a very exciting future. This also is an opportune time for me to return to the West Coast, take on one more set of activities, and spend more time with my family. I've been at Biogen for six years. I'm proud of the company and what we've been able to accomplish in that time. We've introduced six new products onto the market and increased our revenues, earnings, and stock price, all by several fold. And I believe that we're well-positioned to keep delivering on our potential to bring even more therapies to patients and returns to our investors. Our R&D and commercial organizations are now world-class, joining our already industry-leading biologics manufacturing capabilities. All aspects of the company are operating at a high level. We've brought several potentially game-changing compounds into later stage development and are in the process of adding further to that pipeline. With the addition of Michel Vounatsos, Mike Ehlers, and Paul McKenzie, the company has a full and vibrant leadership team that's capable of moving the company thoughtfully forward. I truly believe that the company has a bright future, and it's with mixed emotions that I leave at this time and…

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

Thanks, Michel. In the second quarter, our GAAP diluted earnings per share were $4.79, a 22% increase year over year, while our non-GAAP diluted earnings per share were $5.21, an increase of 23%. Total revenue for Q2 grew 12% year over year to approximately $2.9 billion. It's important to note we had $173 million in foreign exchange hedge gains in the full year of 2015, which impact our year-over-year revenue comparisons this year. In Q2, versus prior year, revenues were unfavorably impacted by $45 million from hedging. Combined with the $1 million benefit from foreign exchange rates, overall revenue was weakened by approximately $44 million year over year. I'll highlight the impact of foreign exchange and hedging on each of our major MS therapies. Global second quarter TECFIDERA revenue was $987 million, an increase of 12% versus the same quarter last year. This included revenues of $780 million in the U.S. and $206 million outside the U.S. In the U.S., TECFIDERA modestly benefited from an inventory rebalancing in the wholesaler channel versus prior quarter. Outside the U.S., foreign exchange and hedge impact weakened TECFIDERA revenue comparison by approximately $13 million. Interferon revenues, including both AVONEX and PLEGRIDY, were $728 million during the second quarter, an increase of 6% versus the same quarter last year. This included $519 million in the U.S. and $209 million in sales outside the U.S. In the U.S., AVONEX also modestly benefited from an inventory rebalancing in the wholesaler channel versus prior quarter. Outside the U.S., foreign exchange and the hedge impact weakened interferon revenue comparison by approximately $17 million. TYSABRI worldwide revenues were $497 million this quarter, an increase of 7% versus the same quarter last year. This included $305 million in the U.S. and $192 million outside the U.S. Foreign exchange and the hedge…

George A. Scangos - Chief Executive Officer

Management

Okay. Thank you, Paul. Financially, I'm pleased with where we are so far this year. Our results year to date have been better than expected. We've raised guidance, and we have a new share repurchase program authorized by the board. We've made good progress towards the three focus areas I discussed after the first quarter: careful management of expenses, maximizing revenues, and rapidly advancing the pipeline. As I look forward and think about the future growth of Biogen, I want to stress how those key focus areas will evolve. The team expects to continue managing expenses, but as you know we can't save our way to growth. Maximizing revenues and rapidly advancing the pipeline will become front and center, especially with Michel and Mike now in their respective roles. Michel's four key priorities of portfolio strategy, commercial excellence, medical leadership, and trust and value will be the pillars we use to maximize revenues. And, under Mike's leadership, we intend to reshape the pipeline, rationalize existing programs, and aggressively pursue promising assets, both internally and externally. We believe this focus will help advance more assets through the pipeline and ideally deliver more therapies to patients. At the same time as we're bringing focus and investment to our core area of expertise in neurology, we'll continue to be opportunistic when we see internal and external opportunities to enhance shareholder value. As a result, we've progressed some of the most promising earlier stage assets that we have in our pipeline, even outside of neurology. We've invested in our biosimilar joint venture to leverage our competitive strengths in manufacturing and commercialization. We've chosen to spin off our growing hemophilia business, because we believe it's the right decision to ensure fit and focus. And, as we've announced today, we'll buy back shares when appropriate. So we've delivered strong financial results this quarter while making progress advancing our pipeline and our commercial business. We have a great leadership team and a passionate group of employees who come to work every day to make a positive impact on patients' lives. It's been an honor and privilege to serve this organization as the CEO for the last six years, and I remain committed to leading the company until my successor is identified. I want to take this opportunity to thank all of our employees for their hard work and dedication. And I want to thank you all for joining us this morning. And the operator will now open up the call for questions.

Operator

Operator

Your first question comes from the line of Mark Schoenebaum from Evercore ISI. Please go ahead.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore ISI. Please go ahead

Oh, hey, guys. Hey, just wanted – George, I wanted to say, I just – the stock only quintupled under your leadership. So I was wondering if you could – I think you should be held accountable for that. So I was wondering if you could address that. No, congratulations. You will be missed. Thanks for the honesty, transparency that you brought to Biogen over the years. And I'd like to know who your least-favorite sell-side analyst is, please. Or just assure me that it's not me.

George A. Scangos - Chief Executive Officer

Management

It's definitely not you.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore ISI. Please go ahead

Okay. Got it.

George A. Scangos - Chief Executive Officer

Management

Especially after that last comment.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore ISI. Please go ahead

Okay. Very good. And, Paul, if you could -

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

You moved up from the bottom, Mark.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore ISI. Please go ahead

Patriots still suck. My question is – this has been asked before, but I just want to kind of engage you guys in a little bit of discussion. Why not release the efficacy data from the titration cohort of the amab trial, given that – I know it's small numbers, but the numbers aren't that much smaller than the individual dose arms that we've already seen. And the follow-up is just can you update us with any specifics on enrollment? Is enrollment tracking within your expectations? And can you just remind us at this point when you'd expect data readouts and if there are interims? Thanks. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Hi, Mark, this is Al.

Mark J. Schoenebaum - Evercore Group LLC

Analyst · Evercore ISI. Please go ahead

Hey, Al. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Hey. So yeah, I mean, if – it makes sense that the number of patients is roughly the same. Our plan is to introduce the safety data, the tolerability data from the titration. But – and efficacy is an exploratory endpoint. I'm sure at some scientific meeting we'll be able to disclose that for completeness' sake. And in terms of enrollment, we're not really commenting on it except to say that we're pleased and that things are on track and we hope to update you more on that in the future.

Operator

Operator

Your next question comes from the line of Brian Abrahams from Jefferies. Please go ahead.

Brian Abrahams - Jefferies LLC

Analyst · Brian Abrahams from Jefferies. Please go ahead

Hi. Thanks very much for taking my question. My congrats to George as well on all your accomplishments, and best of luck in the future. I guess a question on the business development front. As you talk about aggressively reshaping the pipeline and pursuing promising assets, I'm curious your latest thinking in terms of stage of development, sizes of potential deals, the types of assets therapeutically that you might focus on. How are you thinking these days about balancing maintenance of focus on neurology versus further diversifying the business, and how does the CEO transition potentially affect all these goals? Thanks.

George A. Scangos - Chief Executive Officer

Management

Yeah, well, first, let me take that last point first. I don't think the CEO transition affects these goals at all. The company's committed to bolstering the pipeline, and we're working aggressively to do that. And, actually, we would look at deals at all stages of development from pre-clinical through Phase 3. And we are currently doing that. We're in a number of discussions now, and we hope to bring some of those to conclusion. We are focused largely on neurology. That's where we have our core expertise. And I think we believe that the – you can make more sophisticated decisions about things in areas that you understand really in detail. So mainly we're looking in neurology. With Mike's arrival, we have a new person here who's got his own set of expertise, his own views on things. And I would say we wouldn't rule out things outside of neurology, but the bar gets higher as they get further from our center of excellence. As Mike put it yesterday, we want to have kind of laser vision, but we don't want to have tunnel vision. We want to be open to things that are interesting and can provide shareholder value.

Operator

Operator

Your next question comes from the line of Geoffrey Porges, from Leerink Partners. Please go ahead.

Geoffrey C. Porges - Leerink Partners LLC

Analyst · Geoffrey Porges, from Leerink Partners. Please go ahead

Thank you very much for taking the question. And, George, we're not sure what's so special about California, but all the very best of luck with your next chapter. And thanks again for all the information you've shared with us and for the success you've had at Biogen.

George A. Scangos - Chief Executive Officer

Management

Thank you, Geoff. I would say if you're not sure what's special about it, you haven't been there.

Geoffrey C. Porges - Leerink Partners LLC

Analyst · Geoffrey Porges, from Leerink Partners. Please go ahead

So, one question – a couple of questions for Michel, actually. Michel, could you give us a sense of what your contributions from price and volume were on the MS franchise during the quarter on the U.S. side? And then what your price – contributional price effect was on the ex-U.S. side? And then could you secondly add, as you look at the MS franchise, presumably you will have no role in ocrelizumab's commercialization, but nevertheless they're your partner. Could you give us your view of how you see that playing out, in terms of the effect that that drug might have in the MS market and on the outlook for Biogen's own products? Thanks. Michel Vounatsos - Chief Commercial Officer & Executive VP: Thanks for the question. And let me start with ocre, and Paul will comment on the other part of the question. First, I would like to say that we are very pleased and we applaud any new innovation in MS, for which we have contributed, we contribute, and we continue to invest in our pipe. So this is a great news for patients in need, that there are still gaps in therapy. And I think this is a great news, and Roche's results on PPMS is even more encouraging. So we are very happy about that. Having said that, we have a strong presence in the high-efficacy segment of the market. And this is basically a market trend where we can see that basically providers are treating earlier – and physicians – treating earlier, more aggressively. And TYSABRI is holding a very strong position in the highest efficacy segment, and ZINBRYTA will come and will complement this presence here. So I anticipate that ocre will be playing into this segment also, and we will see how it plays. But, for the time being, there is no risk-benefit assessment. So we have to be very cautious before talking. So I'll wait to see regulator stands, but I would say the first approach from, again, a humble but leadership position is to take care of our assets and elevate the capability of the organization, and the four capabilities that we are launching will just do that.

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

Geoff, this is Paul on the price versus volume question. I think the way you framed it is probably pretty accurate, is that it's a tale of two cities. In the United States, the lion's share from a change year-over-year basis is price, and is pretty stable unit trends on TECFIDERA, pretty stable unit trends on TYSABRI and modest, gradual decline on the interferon franchise. Ex-United States, we are not seeing any pricing on a year-over-year basis, and all of the gains are attributable to volume and unit expansion. TYSABRI is holding well outside the United States, as well as the interferon business. And we continue to, in a small way, penetrate some markets and get some accretive benefits of things, even outside of Europe. And TECFIDERA continues to expand on a year-over-year basis and gaining market share, particularly as we are moving into relatively early launch timing in Southern European countries and having very good success in the UK.

Operator

Operator

Your next question comes from the line of Eric Schmidt from Cowen & Company. Please go ahead. Eric Schmidt - Cowen & Co. LLC: Thanks for taking the question, and congrats, George. Good to see you leave on a high note. Best of luck with the next opportunity. Maybe just a quick one for Paul on this new interferon patent that you're paying royalty on or expect to pay royalty on. Can you clarify a little bit whose patent that is and what happened to your own interferon patent that you thought was, at one point, going to be able to extract royalties from others?

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

Yeah, great question, Eric. Thanks. It was, as I noted, unexpected that it is not actually related – despite it is on the recombinant interferon beta protein, it's actually not the same. It has to do with JFCR. In the Q this afternoon, we'll actually have the patent number for you. I just actually don't have it handy for myself, and it's a mid-single digit royalty. We aren't disclosing the name of the third party, but – so just a third party at this point in time. And we expect it will be $50 million impact, all in the second half, effectively, and will be a bigger impact as we go into 2017 on a full-year basis. The '755 patent, we continue to feel like that was a – despite its – was like back to 2009, when it was issued, but we still feel and we're still in litigation with other parties on that. But there's a chance that we're coming towards the end of that process; hope for something favorable.

Operator

Operator

Your next question comes from the line of Geoff Meacham from Barclays. Please go ahead.

Geoff Meacham - Barclays Capital, Inc.

Analyst · Geoff Meacham from Barclays. Please go ahead

Morning, guys, Thanks for the question. George, also want to offer my congrats. You will be missed. So I had a question for Michel, maybe a bigger-picture commercial question. Now that you've had a chance to look at the products, the assets at Biogen, and a fresh look at the MS market, maybe just give us some perspective on what you see as the bigger growth opportunities ahead on a volume basis. Is it geographic? Is it rest-of-world opportunities? Is it new product launches? And then maybe for Paul, just wanted to check and see what you guys learned from the DTC campaign for tech and the sustainability of that. Thanks. Michel Vounatsos - Chief Commercial Officer & Executive VP: Thank you for the great question. You know, in my 25 years' experience around the world, I have never seen such a situation whereby we have five or six assets in the same therapy area. The 20 years of very solid – unique, I would say – experience in MS, a solid portfolio today. A solid pipeline. A remarkable group of talent with clinical experience and scientific experience within the company. So it's a leadership position on interferons, a leadership position on orals. A leadership position on high-efficacy products. So this is a remarkable situation. And on top of that we are launching ZINBRYTA. So the dynamic is very good. Having said that, when you peel the onion and you get to discover the opportunity and the operations, you find ways to do better. And this is why together with the team we have prioritized four key areas, portfolio management, five, six assets in the same therapy area. It's a challenge on how to manage that well. Commercial excellence, medical leadership, trust and value. And I believe that, with those, we'll be able to make a further difference. Geographically, also, we can see that some parts are better managed than others. And I have already started to make some decisions. We don't wait. And you can expect that more will come. So this is what I would like to say – and, you know, the portfolio management doesn't mean that all the products will be resourced and promoted equally. It's all about the growth opportunity, the way that you outline. And this is where there will be a clear, I would say, alignment between those, resource allocation, and execution.

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

Geoff, the beginning part of your question is – yeah, just to confirm, we have sunsetted the television campaign as it relates to TECFIDERA. I think our – I mean, look, it was a innovative – I'd applaud our organization for thinking about it and giving it a try. I think that our judgment at this point is that it didn't have a discernible movement on scripts. And potentially came – this more, as much from anecdotal – with some drawbacks as well. Michel actually confirmed his – from his perspective that there quite possibly is much other levers that are still like DTC-related and multichannel-related that we can reallocate resources toward. So I think that's probably our learnings in a nutshell. We didn't run the test case, so we'll see what – but I think that's our learnings. Michel Vounatsos - Chief Commercial Officer & Executive VP: Thank you, Paul. This is Michel. If I can add – I mean, at the outset, and I was not here, the main objective was increase awareness, and I think that this was achieved. But I didn't see any inflection on any trends. We need to circle back to the alignment of the organization on four priorities for which we need to have some very strict resource allocation decisions, and I don't think that broadcast TV will be there in the foreseeable future.

Operator

Operator

Your next question comes from the line of Cory Kasimov from JPMorgan. Please go ahead.

Whitney G. Ijem - JPMorgan Securities LLC

Analyst · Cory Kasimov from JPMorgan. Please go ahead

Hi. This is Whitney on for Cory. I'll add my congrats to George as well. I guess just to circle back on Alzheimer's. I guess, where are you with sort of combinations, and I guess what's the desire or urgency to get some of the combos into the clinic before you maybe have Phase 3 data on any of the individual components? Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: This is Al, Whitney, and we like the idea of combinations. I think one day we will be using combination therapies for Alzheimer's disease. One of the reasons why we brought in BACE inhibitor into our pipeline with our collaboration with Eisai, the reason why we have tau programs internally and that we're in search of even other things potentially to add to the mix is based on, in part, on that belief, that combination could be helpful. And you can think of it in two ways. One is to combine two drugs, each of which are active, to increase the efficacy overall, or to reduce the dose of two active therapies so that you get better safety or tolerability for the same efficacy. And also there may be sequential treatments where you start early, perhaps even before symptoms, with one type of medicine and then treat with something else when you have a high plaque burden, and then something else still when tau starts to progress. When you start to think about combination therapy, though, it's often difficult to do the right studies without some evidence of efficacy of each drug as monotherapy. And then you can start to think about the right dosing regimen. And so I hope that's helpful.

Operator

Operator

Your next question comes from the line of Michael Yee from RBC Capital Markets. Please go ahead.

Michael Yee - RBC Capital Markets LLC

Analyst · Michael Yee from RBC Capital Markets. Please go ahead

Oh, hey, thanks. Good morning. My appreciation to George as well. Happy to see you joining me on the West Coast. I'm lonely out here, so happy to have you back here. Hey, a question for Al. There will be LINGO data presented at ECTRIMS. Can you maybe revisit this briefly and give us some color about what is going on here in terms of what we saw? Because obviously that was a surprise. And I guess is there anything specific that we should pay attention to at ECTRIMS that you've done work on that would pique our interest back here? Or is there some issue here with the remyelination pathway and that would bring our questions into your oral. So how does this change our thinking about remyelination and what we saw here? Thanks. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Yeah, Michael, thanks for the question. So first I want to say this is a really large and rich data set. Really the first of its kind, not only in MS, but to my knowledge, in neurology where we're in the early stages of figuring out how to repair the brain and how to measure measurements of – outcome measures of repair. The things we're focusing on right now when we look at this rich data set are what are the right cohort of patients to treat? In this trial, we looked at relapsing MS patients all the way to secondary progressives. So it's a wide range of patients. What's the optimal cohort? What's the right dose? We studied four different doses, and we saw a complex dose-response curve. What we actually saw was a sort of a bell-shaped curve where we lost efficacy at…

Operator

Operator

Your next question comes from the line of Robyn Karnauskas from Citigroup. Please go ahead.

Robyn Karnauskas - Citigroup Global Markets, Inc.

Analyst · Robyn Karnauskas from Citigroup. Please go ahead

Hi, guys, thanks for taking the question. I guess, George, I remember meeting you when you first became the CEO, and I remember you talking about refocusing the company and like getting rid of certain pipeline products, and it was so well-needed at the time. It really changed Biogen. And so now I think the company's a different company, and there's been pipeline success and there's been some failures. What do you think Biogen really needs from a new CEO at this point in time versus when you came in?

George A. Scangos - Chief Executive Officer

Management

Well, look, the company now is a very different company from what it was a few years ago. We have a full and excellent management team. We have a pipeline that is, I think, quite exciting but needs to grow. So I think the company needs good management. I think the strategy of the company is solid. And what we need is good leadership and somebody who can work with the people who are here – work with Michel, maximize the commercial potential, work with Mike, maximize the potential of our pipeline, grow the pipeline, and can work with the rest of the organization to ensure that we go forward in a way that is responsible, where we minimize expenses but that where we invest aggressively in those areas that really have the potential to add value. So being CEO is complicated, and I think those are the priorities I would set. Of course the search will be conducted by the board, but I don't think they would view it too differently. I think there'll be a continued focus on innovation, and I'm confident we'll get someone excellent.

Operator

Operator

Your next question comes from the line of Ronny Gal from Bernstein. Please go ahead. Ronny Gal - Sanford C. Bernstein & Co. LLC: Good morning, and thank you my questions. Two questions first. Biosimilars, you had a pretty good first quarter. Can you describe a little bit to us where you've launched already, where you're still expecting to launch? And now that you have a little bit of – wetted your feet in that market – can you just give us a feel for your thinking about kind of the three- to five-year trajectory for this franchise and for biosimilar for anti-TNFs? In Europe in general, should this be 30% of the market, 50%, 70% of the market overall? And then separately, you kind of mentioned the impact of high detectible copays on the U.S. sales in the first quarter. Has there been still some impact to those in the second quarter? That is, as we look from the outside of revenue, should we see another step up in revenue per unit in the third quarter, or has it been fully incorporated in the first quarter, and kind of the run rate for pricing in the second quarter is roughly what we should see going forward? Michel Vounatsos - Chief Commercial Officer & Executive VP: So this is Michel. Thanks for the great question. So as you have seen, two great companies came together with complementary capabilities in order to launch anti-TNFs to get started with, and then we see what is the follow-up opportunities. So as far as Biogen involved together with the partners, we have launched the products; the three anti-TNFs for which we have the agreement on, two out of the three are approved and on the way to be launched. The preliminary results are very encouraging. As you can imagine, there is a tremendous level of variation – variability between countries in terms of tendering, in terms of [aggressivity of petition] in terms of provider decision-making, and it's difficult to take an overall, I would say, recipe on how to best launch. What I can say is that the three anti-TNFs that we'll have the opportunity to launch will be addressing a current market that is higher than $9 billion in Europe. So this is significant. And with Biogen quality. So we have put together a standalone BU that is flexible, agile, in order to launch the product, and we learn country after country. Today, mostly in the Nordics and Scandinavia, where we have had very, very good results. But, as I said earlier, it's still early to comment much on the results that are negligible for 2016 but will be more important moving forwards.

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

Ronny, this is Paul. Thanks for the second part of that question. It's a good catch. I think the answer is that we absolutely saw our insurance dynamics mostly impact AVONEX in the first quarter. And we're pleased to see that that choppiness settled out and benefited the second quarter results. Don't expect it to be a meaningful difference for the balance of year now.

Operator

Operator

And your final question comes from the line of Chris Raymond from Raymond James. Please go ahead. Christopher Raymond - Raymond James & Associates, Inc.: Hey, thanks for squeezing me in, and congrats, George, from us as well. Just a question I guess on TECFIDERA. In the context of – I think you highlighted in Q1 a $20 million inventory drawdown. Could you maybe quantify – I think you highlighted generally there was an inventory effect in Q2. Can you quantify what that was? And then also if I can on TECFIDERA, continuing, I hear what you're saying on the television ads, but one of the things that has struck us the most with our checks is TECFIDERA, for some time, has been sort of far and away the most requested disease modifying therapy among patients. I guess I'm wondering, what additional levers can you pull to sort of increase that? Or is there some other aspect like maybe working at better efficiency programs to get that request converted into a script? Is there some other aspect besides just getting patients to request the drug?

Paul J. Clancy - Executive Vice President, Chief Financial Officer, Biogen, Inc.

Management

Yeah, thanks, Chris. It's Paul; I'll talk the first part. It's quite simply, I think we're at a – pretty normal inventory levels on TECFIDERA, so it's really just a sequential quarter rebalancing off of the seasonal low that we generally see in Q1. Michel Vounatsos - Chief Commercial Officer & Executive VP: So on the levers and the performance, 12% growth Q-over-Q is not bad. The share continues to grow to 15% globally, is also pretty good, mostly driven by the newly launched markets in Europe, 40% patient growth percentage is also very encouraging. I have, from my field visits and from talking to leaders, identified one major issue, which is the discontinuation due to GI safety. Those patients during the first phase on the product are suffering, for some of them, on abdominal pain, diarrhea, discomfort, that is leading, in some cases, with very high level of variability, to discontinue the product. And this impacts not only the outflow but eventually the inflow. Variability is tremendous. I was in the field lately, and on the Eastern coast in the U.S., 1.5% of the patient discontinued at six months. In some others, it was 30%. So, with Mike Ehlers, we are fully aligned in order to work together with the community, with the physicians, with peer to peer in order to best assist, best educate, and bring down an average which is at 20% today to lower levels.

George A. Scangos - Chief Executive Officer

Management

Okay. With that, thank you all for joining us this morning. Thanks for the questions, and we'll sign off now.

Operator

Operator

This concludes today's conference call. You may now disconnect.