Earnings Labs

Biogen Inc. (BIIB)

Q4 2015 Earnings Call· Wed, Jan 27, 2016

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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 fourth quarter and year-end 2015 financial results and business update. Thank you. I would now like to turn the call over to Mr. Matt Calistri, Senior Director of Investor Relations. You may begin your conference.

Matthew Calistri - Senior Director of Investor Relations

Management

Thank you, and welcome to Biogen's fourth quarter and full-year 2015 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. Al Sandrock, our Chief Medical Officer; and our CFO, Paul Clancy. Now I'll turn the call over to George.

George A. Scangos - Chief Executive Officer

Management

Thanks, Matt, and good morning, everyone, and thanks for joining us today. In 2015 Biogen generated revenues of $10.8 billion, an 11% increase over 2014, and non-GAAP EPS of $17.01, a 23% increase over 2014. Although the revenues were less than we'd anticipated at the beginning of last year, I'm pleased that we were able to take appropriate action in the second half of the year to maintain healthy earnings growth while we continue to advance the potentially transformative therapies in our pipeline. TECFIDERA's demand has been stable in the U.S., and combined with growth in Europe we expect TECFIDERA to continue to drive our global leadership in multiple sclerosis. TECFIDERA is now not only the most prescribed oral MS therapy worldwide; it is also the most prescribed of all MS therapies in Germany, France, and the U.K. Overall, more than 170,000 patients have been treated with TECFIDERA. Our hemophilia products, ELOCTATE and ALPROLIX, generated over $0.5 billion of revenue in their first full year on the market in the U.S. In November, the European Commission approved ELOCTA for the treatment of hemophilia A in the EU, which we believe will help to contribute growth in hemophilia this year as our collaboration partner Sobi commercializes ELOCTA in additional markets. We also made progress in business development. We acquired Convergence Pharmaceuticals and raxatrigine, their lead compound. Raxatrigine is an oral small-molecule Nav1.7 blocker with promising Phase 2 data that will move into Phase 3 this year. We licensed amiselimod, or MT-1303, from Mitsubishi Tanabe Pharma, a late-stage S1P1 inhibitor for ulcerative colitis and Crohn's disease. We entered into a collaboration agreement with AGTC to develop gene-based therapies for multiple ophthalmic diseases. And this month BENEPALI was approved in the EU. BENEPALI, the first etanercept biosimilar approved in the EU, is the…

George A. Scangos - Chief Executive Officer

Management

Okay, thank you, Paul. Clearly the commercial trajectory of TECFIDERA was not what we thought it would be at the beginning of last year, and as a result our revenues fell short of our initial projections. While obviously not happy with that, I'm very pleased with the way the company responded. We put additional marketing muscle behind TECFIDERA, we reduced costs and focused the company, and we accelerated our stock repurchase program. As a result, we maintained healthy earnings growth at the same time as we continued our investments in aducanumab, LINGO, and the other exciting programs in our pipeline. We also continued to invest in additions to our pipeline. We acquired Convergence and its lead compound raxatrigine; we licensed amiselimod from Mitsubishi Tanabe; we completed the gene therapy relationship with AGTC; and we brought additional compounds into the clinic from our own and our partners' research efforts. Our commercial portfolio continued to expand globally, as we extended our position as the worldwide leader in multiple sclerosis and significantly grew our hemophilia business. In 2016, we plan to remain focused on commercial execution and advancing our pipeline, which we expect to be the primary source of value creation over the long term. We're looking forward to many updates over the next year, including insight into the potential impact of TECFIDERA's recently launched marketing campaign by the second quarter; Phase 2 top line results for anti-LINGO in MS in the middle of the year; Phase 2 data for BAN2401 and E2609; continued Phase 2 data for nusinersen from Ionis, followed by Phase 3 data next year; and Phase 1b titration data for aducanumab in the second half of the year. We expect to launch up to three compounds this year: BENEPALI in Europe following approval from the European Commission earlier this…

Operator

Operator

Your first question comes from the line of Geoff Meacham from Barclays. Your line is open.

Geoffrey Meacham - Barclays Capital, Inc.

Analyst · Barclays. Your line is open

Morning, guys. Thanks for taking the question. Just have a couple of quick ones, one on the commercial side. I know it's early days, but are there any initial metrics on the TEC DTC campaign when you look at things like new starts or returning patients? And then the second one is on the pipeline. When you look at the ENGAGE and EMERGE studies, Al, are there lessons to be learned from Lilly in terms of managing PET scan facilities? And what do you think identification of early-stage Alzheimer's patients means to the market opportunity? Thank you.

George A. Scangos - Chief Executive Officer

Management

Thanks, Geoff. Let me start with the TEC DTC question. I guess I'd reinforce what we said in our prepared remarks around, that really to try to discern it we're going to be looking kind of in Q2 time period. I mean, clearly Q2's not a light switch to determine that. We're seeing early data with respect to, as I had mentioned, kind of hits to the website, conversations into our patient services organization, which lean us to think that it's positive. We haven't seen a discernible, yet, change with respect to specifically your question, but our judgment is that this takes a little bit of time. It was really first week of October. Obviously script data as we come through the holiday time period, as everybody knows, gets a little bit noisy in Thanksgiving and December. So we are going to look really hard probably 60, 70, 90 days out from now. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Hi, Geoff. This is Al. Well, we have learned a lot from our predecessors, including Lilly and others, and we are employing actually pretty innovative ways of finding where the patients are and where the sites are, and which includes where the PET scans are, because the scanners have to be pretty close to where the ligands are made, and of course the patients have to get there. The other thing we're doing is to screen patients before they need PET scans by using a neuropsychological test battery to make sure that by the time they get to the PET scanner, there's a high likelihood they'll actually have amyloid. And then in terms of early AD, what we mean by early AD are prodromal and the earlier stages of mild Alzheimer's. And in terms of what it means for the marketplace, I do believe that there's going to be a change ultimately in the way the patients are diagnosed early. Perhaps, and certainly before there are functional deficits, but when they have mild cognitive impairment, I believe the healthcare system will set up ways of identifying those patients who need treatment early. And we're working on many of those, too, along with many colleagues outside who are also thinking about the same thing.

Operator

Operator

Your next question comes from the line of Eric Schmidt from Cowen & Company. Your line is open. Eric Schmidt - Cowen & Co. LLC: Maybe another one for Al. It looks like you're going to be faced with a couple of go/no-go decisions on Phase 3 programs in 2016. I'm thinking specifically for LINGO and for the BACE compound E2609. I'm just kind of wondering what kind of hurdle you've set for yourselves in terms of going forward. And maybe you could also further justify, if the hurdle is going to be kind of the low-end hurdle – I sense that's what you've been signaling to investors – why it makes sense to move forward with two fairly risky programs of lowish-end hurdle. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Well, I wouldn't say that the hurdle's very low. I think what I'm trying to say with LINGO is that this is a Phase 2 trial, and it's pretty novel territory we're on, where not too many people have looked at repair strategies for any neurologic disease, including MS. So I would say that we're going to look at the totality of the data. We're going to combine the clinical outcome measures along with the imaging outcome measures, learn as much as we can, and really decide, does the program deserve a continued investment? And if so, can we go to Phase 3? Are we ready to go to Phase 3? Because in Phase 3, we're going to have to employ outcome measures that everybody agrees – including regulators, obviously, but also the MS community – everybody agrees will provide answers on whether or not the treatment effect is clinically meaningful. And in the case of the BACE inhibitor, the main thing we're going to be looking at is safety, and I don't think it's uncommon – in fact, I think all of our competitors have gone from early-stage safety data right to large registrational trials, and I think there are good reasons for that. We are confident in the pharmacodynamic effect that we see, in that when we look at A beta 42 levels and CSF, we get nice, very strong dose-dependent decreases in A beta 42. So we're not going – I mean, as George said, we want to manage the risk by making sure we have the desired biological effect, and we're pretty confident already that we have that.

Operator

Operator

Your next question comes from the line of Brian Abrahams from Jefferies. Your line is open.

Brian Abrahams - Jefferies LLC

Analyst · Brian Abrahams from Jefferies. Your line is open

Hi. Thanks for taking my question. Two quick ones. On TYSABRI, it looks like you're seeing stabilization. Wondering if you could talk a little bit about the dynamics you're seeing there amongst patients since the SPMS data was reported? And then for Paul, just curious – you earmarked about $100 million for BD next year – how the sector pullback amongst the smaller biotechs might influence your capital allocation strategy this year. Thanks. Paul J. Clancy - Chief Financial Officer & Executive Vice President: Yeah, why don't – I'll try to take the TYSABRI one as well, but Al can chime in here. Thanks, Brian, for the question. Yeah, we did not see a discernible change kind of coming out of the SPMS readout. It may be early; it may not. I think that was to some extent our thesis as well. Patients that are doing very, very well and have an individual experience with TYSABRI that's generally quite positive. With respect to the earmarking for $100 million, it's – we always debate this internally. Should it be more than that? Should it be less? Should we trade it off against R&D dollars? All that type of stuff. But we try to earmark some level of money that obviously is expense money, which has been – we've been a little bit biased that way, with the earlier stage biotechs over the last number of years have had opportunities, right? The IPO window has been open. It's been very open for them to continue on. There's a potential that with the change in the biotech sector, that as we've looked at corporate development, business development type deals, clearly one of the last hurdles to get through is financial valuation. There's a change that that dynamic is changing in favor for us. George will maybe add some comments as well.

George A. Scangos - Chief Executive Officer

Management

Yeah. Look, if you're in a smaller biotech company, and it's pre-commercial, and you have to raise revenue, there are only a couple of ways to do that. And as it gets more difficult and less attractive to raise money from the financial markets, obviously other alternatives become more attractive. And we hope that and we believe that will all move in the favor of companies like us who are out to in-license or acquire additional compounds. So we'll see. It takes a while for that to happen. We'll take the current views of the market to hold for a while or deteriorate further. If that happens, then I believe there'll be interesting opportunities for us.

Operator

Operator

Your next question comes from the line of Mark Schoenebaum from Evercore ISI. Your line is open.

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum from Evercore ISI. Your line is open

Hey, guys. Hey, Paul, Al, George. Thanks for all the transparency after the guidance lowering last year and on the call today. Really appreciate it. I think the Street does, too. Just a couple questions since everyone's breaking the one question rule.

George A. Scangos - Chief Executive Officer

Management

I think you started that trend, Mark.

Mark J. Schoenebaum - Evercore ISI

Analyst · Mark Schoenebaum from Evercore ISI. Your line is open

No, well, I'm like the fifth question. Everyone's asked two. So it's not me. I'm a good boy. On TECFIDERA, Paul, I remember last year – I know you're not providing TECFIDERA guidance for 2016, but I think last year you gave some color on your expectations. I'd be curious to know if you'd be willing to do that this year. And specifically what are you expecting for price and volume in 2016 in the U.S.? Should we be modeling any price, any volume? And then on LINGO, Al, this has come up in prior questions, but just to push you a little bit, when you say separation, should we think of that as common-sense separation on the clinical endpoints would be clinically relevant? Or in that we don't necessarily need statistically a T-value of under 0.05 when you're analyzing the data in order to make a go decision into Phase 3? Thanks a lot. Paul J. Clancy - Chief Financial Officer & Executive Vice President: Mark, this is Paul. The only additional – I really don't want to provide anything additional, no comments further. Just – but reinforce what I did say in the prepared remarks. On TECFIDERA, our plan assumes stable demand for TEC in the United States, right? We're looking and aspiring for more, but that's what the plan assumes. And that's really what we've seen for a number of quarters. On the U.S. pricing side, our financial guidance assumes no U.S. prices for TECFIDERA for the remainder of the year. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: On LINGO, Mark, we have a trial with about 80 patients per arm. And so it's not – it's a robust trial. But, yeah, I think we're more on the common-sense side, as you put it. We want to know – and we can look at separation in several ways. I mean, we can look for proportion of patients who are improving relative to placebo, and we can look at patients who are slowing – their progression has slowed. So we can look at both ways. And that's sort of what I mean by separation. But I think it's more on the common-sense side. And I tried to indicate that there's a lot of exploratory pieces to this trial, because – and some of these endpoints have really never been employed in any significant way in large trials. So that's what I was trying to say, Mark.

George A. Scangos - Chief Executive Officer

Management

I think, Mark – this is George. The decision on the LINGO trial will be whether or not we have a meaningful clinical impact on endpoints that the regulators would consider approvable endpoints in a Phase 3 trial. All right? And there are many endpoints that we're going to be looking at in the trial, and there could be some combination of them. So we're not going to have a low bar, but it is a Phase 2 exploratory study, and as we look at those endpoints, we'll make decisions. But I wouldn't characterize it as a low bar. I'd characterize it right now as a little bit of an undefined bar until we see the data.

Operator

Operator

And your next question comes from the line of Michael Yee from RBC Capital Markets. Your line is open.

Michael J. Yee - RBC Capital Markets LLC

Analyst · Michael Yee from RBC Capital Markets. Your line is open

Thanks for the question. On SMNRx – and I refer to it as that because I can't pronounce your new name – could you just talk a little bit about some of the data you've seen so far? And how you're – some of your commentary has changed around that a little bit to the positive, which is fine, but I guess it always comes down to comparing historical literature, and there's a lot of different things out there. So, Al, can you maybe just talk a little bit about your confidence in the literature and the range of median survival there and what you think is going on here? You previously talked about weight gain, but I haven't really heard about that. So I guess maybe talk a little bit about that and what you're seeing, and I guess why versus historical literature you feel I guess a little bit better. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Yeah. So the main data we're looking at is the Type 1 SMA, or the infantile onset. And, as you know, we're comparing it – we and with our partner Ionis – are comparing it to natural history. And those things are always tricky, because natural history – the care of patients change over time and stuff like that, and you have to sort of find matching patients, patients that are similar to the ones that you looked at in your open-label study. My confidence grows with every passing day because, as you know, these children are supposed to – their median survival is two years. And so we're at the point where many of these babies are getting to that point or going beyond it, and so I think that if they're surviving, our confidence grows. And also – we're also looking at whether or not they're gaining, whether they're making improvements. These children generally don't improve, and they're hitting motor milestones that are not commonly seen in the natural history. So we believe the data are looking promising, but there are caveats to comparison to natural history studies, and we have to be cautious, because everybody, including parents and the whole world, wants to see a cure for these babies. So our bias is certainly leaning toward wanting to see something, and we have to be cautious about that. So the Phase 3 trials are sham-controlled, they're blinded, and I think that's where we believe the definitive data will come from.

Operator

Operator

Your next question comes from the line of Matthew Harrison from Morgan Stanley. Your line is open. Matthew K. Harrison - Morgan Stanley & Co. LLC: Great. Thanks, and good morning, everybody. So I'm going to ask two. One on Alzheimer's – we've recently had a handful of physician feedback that there's a dearth of skilled readers for some of these endpoints in these studies. Can you just talk a little bit about what you're doing to make sure the readers are well-trained, especially given that a small change in the endpoints is likely to demonstrate the benefit of the drug? And then just on LINGO, can you remind us what our expectations should be? I remember in 2015 when you moved out the timelines, you said that a small internal group would be seeing some of the LINGO data ahead of sort of the full analysis, and they'd be planning for Phase 3. Should we expect if you decide to move ahead for Phase 3 you'll be able to talk about that pretty quickly when we see the data? Thanks. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Yeah. Let me get the second question first. I want to be sure that the trial remains fully blinded. Nobody at Biogen has broken the blind and looked at the unblinded data. So that small team – there's no small team looking at any data. And in terms of the AD, there are – it is sort of an art to read PET scans. I don't know if that's what you're referring to, but the readers of these images have to be trained, and we actually employed a quality-control step in a blinded way, where we had somebody in Minnesota, an expert, reviewing every single scan. Moreover, in terms of the cognitive testing, the clinical outcome measures, the main thing we want is consistency over time, and we're doing a lot of the things that we actually do in MS, where we do a lot of training, we have examining neurologists, and we separate them from the neurologists that actually treat the patients for side effects and things. So I think we've employed sort of state-of-the-art methods for collecting these data and hopefully avoided many of the pitfalls.

Operator

Operator

And your next question comes from the line of Chris Raymond from Raymond James. Your line is open. Christopher Raymond - Raymond James & Associates, Inc.: Hey, thanks, guys. Just a couple of quick commercial questions. Paul, on TECFIDERA you guys called out the $30 million of inventory during the quarter, and I think Q3 saw $10 million to $15 million, if I recall correctly. So how should we think, I guess, about Q1? Are we talking about $40 million to $45 million that needs to be burned off, or is there some other dynamic there that we should be modeling? And then also on PLEGRIDY, just wondering if you could share any insights on, as the launch has progressed, any change specifically in the source of patients, either from AVONEX or other beta interferons? And I guess I ask this question because some of our checks seem to indicate there's been a shift where PLEGRIDY is taking patients now from other beta interferons versus more from AVONEX early on. I'm just kind of wondering if that's what you're seeing, too, or if there's something else going on there? Thanks. Paul J. Clancy - Chief Financial Officer & Executive Vice President: Chris, great questions. It's Paul. TECFIDERA, let me just kind of level-set and just clarify, because you're exactly on it. What we had noted in Q3 is that our estimate at the time was that there was about $10 million to $15 million of build in the SPP, in the specialty pharmacy part of the combined channel. And that was mostly what we believe related to a government purchase related to kind of their fiscal year timing. I think our belief is that that's largely burned through. On a quarter-to-quarter basis within specialty pharmacies, there is sometimes ebbs and…

Operator

Operator

Your next question comes from the line of Terence Flynn from Goldman Sachs. Your line is open. Cameron Bradshaw - Goldman Sachs & Co.: Hi, this is Cameron filling in for Terence. Thanks for taking our question, and congrats on your approval of your ENBREL biosimilar in the EU. I was wondering, is there anything you can share regarding your pricing and commercialization strategy there? Thanks.

George A. Scangos - Chief Executive Officer

Management

Cameron, obviously we're in discussions country by country, but really can't share anything, so no comment on that. We'll try to as we begin to post revenues, to try to provide some commentary.

Operator

Operator

Your next question comes from the line of Matt Roden from UBS. Your line is open.

Matt M. Roden - UBS Securities LLC

Analyst · Matt Roden from UBS. Your line is open

Great. Thanks for taking the question, and thanks for delivering a nice quarter and guidance here. I think as a sector we needed some good news. So I had kind of a specific on the BACE inhibitor E2609. The Phase 2 study is in 700 patients, but my understanding is that the data that we'll get on this year's disclosures is just on safety from the initial cohorts, not the whole 700 patients. So can you just clarify what we should expect to see from this disclosure this year and help us understand what exactly you'll be looking for and how this information would pertain to a go/no-go decision? And then lastly just when we'll get initial efficacy findings from this program. Thanks. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Yeah, you're right, Matt, were going to look at the first cohort. And the original plan was that the first cohort would then trigger a second cohort. The main thing we're going to look at is the safety data from the first cohort and also to confirm the pharmacodynamic effect that we saw with our Phase 1 study. So it's really safety and repeat, or confirmation of pharmacodynamic effect in the CSF.

Matt M. Roden - UBS Securities LLC

Analyst · Matt Roden from UBS. Your line is open

Okay. And then does that pertain to any go/no-go decision? Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Yeah.

Matt M. Roden - UBS Securities LLC

Analyst · Matt Roden from UBS. Your line is open

And then when should we expect to see initial efficacy? Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Well, with the number of patients in the first cohort, I have low expectations in terms of efficacy, and it will lead to a go/no-go decision to Phase 3.

Operator

Operator

Your next question comes from the line of Ying Huang from the Bank of America Merrill Lynch. Your line is open.

Ying Huang - Bank of America Merrill Lynch

Analyst · Ying Huang from the Bank of America Merrill Lynch. Your line is open

Hey, good morning. Thanks for taking my questions. Maybe for Al, you mentioned that you should expect the enrollment, a full enrollment of aducanumab Phase 3 similar to the timeline of the other Phase 3 trial. Does that mean we should probably expect 18 to 24 months or potentially even longer for the enrollment be accrued? And then also secondly, I was curious your thought on TYSABRI, because ocrelizumab could be approved probably towards end of this year. We know that about 30% of the JCV-positive patients are all on TYSABRI – I mean, sorry, 30% of TYSABRI patients are JCV-positive. And then there's also a certain level of off-label use from PPMS and SPMS. So if you could provide some thought on that. Thank you. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: So in terms of enrollment, I don't want to hazard a guess as to exactly how long it's going to take to enroll patients. I think we're pleased with what we've seen so far, but it's early days. And right now our timelines are assuming the enrollment rate on a patients-per-site basis to what we've seen with other Phase 3 trials. And then in terms of ocrelizumab, it's great to have a new drug for patients, particularly for PPMS patients. I don't think there were a lot of PPMS patients who were on TYSABRI, if that's what you're asking. There probably are some people who have SPMS on TYSABRI, because our label says relapsing forms of MS, and patients with SPMS have relapses in their early stages of SPMS. So it would be on label to be on TYSABRI if you have relapsing SPMS. Now, ocrelizumab I don't think will have a label for SPMS, as far as I understand. I don't recall that they did a trial on SPMS, so I don't see how that would affect the SPMS piece very much.

Operator

Operator

Your next question comes from the line of Cory Kasimov from JPMorgan. Your line is open.

Cory W. Kasimov - JPMorgan Securities LLC

Analyst · Cory Kasimov from JPMorgan. Your line is open

Hey, good morning, guys, and thank you for taking the questions. I guess first for Paul, on capital allocation, now that you've finished the $5 billion share repurchase program, do you have plans to start another one? I'm just curious how we should be thinking about share count in 2016. And then also, Paul, in your comment with regard to price increases not being assumed in your 2016 guidance, can you just remind us how you've build that into past guidance in prior years? And is this a change that's simply the result of the current pricing environment and controversy? Thanks. Paul J. Clancy - Chief Financial Officer & Executive Vice President: Yeah. With respect to – let's kind of start on capital allocation and share repurchases. And you're right, we've exhausted the $5 billion share authorization that was authorized and approved by the board back in the spring of 2015. George and I are in constant contact and constant dialogue and constant discussion about best deployment of capital. I think our thinking right now is a bit focused on strategic deployment, but I would continue to emphasize that we always frame this as one or the other. And it's – over a long period of time, it's appropriately a mix. And I think the cash flow generation of the company remains quite robust such that we can deploy capital in a lot of different ways, all with the objective of increasing intrinsic value per share. So we'll look towards a lot of different means. I mean, I know I'm being a little bit vague and opaque, but I think it's just because that's a little bit where we are right now in thinking through all the dynamics of that. No real comment on the pricing dynamics for the balance of the year. The financial guidance for this year does not assume it.

Operator

Operator

Your next question comes from the line of Jim Birchenough from Wells Fargo. Your line is open.

Nick Abbott - Wells Fargo Securities LLC

Analyst · Jim Birchenough from Wells Fargo. Your line is open

Hi, this is Nick in for Jim this morning. A couple of quick questions. In terms of the remyelination programs, you have the oral remyelination agent BIIB061. Clearly, remyelination is a very complex process. Have you looked at combining that with anti-LINGO? Do you see remyelination as a single-drug opportunity, or do you think it's going to need combination therapy in perhaps some subsets of patients? And if the Ionis SOD1 trial – for these kinds of trials where you're looking at these very rare defined sort of mutations or correction opportunities, do you see the pattern repeating that we saw with nusinersen that you can generate enough compelling data in a Phase 1 trial in affected patients that you can jump into a potentially registration enabling trial? Thanks. Alfred W. Sandrock, Jr. - Executive Vice President, Neurology Discovery & Development Center, Neurodegeneration Therapeutic Area and Chief Medical Officer: Yeah. Thanks for those questions, Jim. On the remyelination, right now we're thinking of it that we would use one agent for remyelination, based on our preclinical studies. Of course the remyelinating drug would probably be combined with an anti-inflammatory or an immunomodulatory drug, and that's exactly how we're conducting the SYNERGY study of anti-LINGO-1 in MS. We're adding it to interferon. But right now we don't have any plans to combine the two remyelinating drugs that we have in our pipeline. That may change over time, but that's our current plan. And then terms of the Ionis SOD1 Phase 1 trial, yeah, we've done a lot of work – "we" meaning Biogen, also the ALS community – on biomarkers and not only in human studies, because you'll recall that there was a prior antisense study with a less potent antisense in SOD1 patients. And there's been some – a lot of animal work. And we actually have CSF measures that we could employ that we think will predict parenchymal spinal cord SOD1 levels. The whole point of what we're trying to do is to reduce levels of SOD1, because we believe that the mutated forms of SOD1 are toxic. So we have actually validated, we believe, very good measures that we can use to take the program from the current trial to a registrational study.

George A. Scangos - Chief Executive Officer

Management

And this is George. I think that's often the case and the advantage of working on genetically homogeneous diseases, the result of a single gene. So look, I want to thank everybody for your attention this morning and for your interest. We are going to go back to work and do our best to deliver a great 2016 for everyone. So thank you.

Operator

Operator

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