Earnings Labs

Biogen Inc. (BIIB)

Q1 2017 Earnings Call· Wed, Apr 26, 2017

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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 first quarter 2017 financial results and business update. All lines have been placed on mute to prevent any background noise. After the speaker's remarks there will be a question-and-answer session. Thank you. I would now like to turn the conference over to Mr. Matt Calistri, Senior Director, Investor Relations. You may begin your conference.

Matthew Calistri - Biogen, Inc.

Management

Thanks, Dan. Thank you and welcome to Biogen's first quarter 2017 warnings conference call. Before we begin I encourage everyone to go to the Investor 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 one and two. Table three 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've 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 the risk factors discussed in our SEC filings for additional detail. On today's call I'm joined by our Chief Executive Officer, Michel Vounatsos; Dr. Michael Ehlers, EVP of Research and Development; and our CFO, Paul Clancy. We'll 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 Michel.

Michel Vounatsos - Biogen, Inc.

Management

Good morning, everyone, and thank you for joining us today. I am especially pleased to welcome you to this call as the CEO of Biogen. Before I turn to the details of the quarter I would like to share some initial thoughts on how Biogen is positioned today and where we see the company progressing. We do have a differentiated expertise in neuroscience and expect this to remain our core moving forward. We intend to maximize the potential of our R&D assets and bolster our pipeline through both internal and external opportunities. We are focused on flawless commercial execution in our priority geographies across MS, SMA, and biosimilars. We are aligning the organization around these goals including building our senior management team. We want our actions to speak louder than our words. As you will see throughout the rest of the call, I think we are already off to a great start. Q1 was a very good quarter financially and also a quarter with exciting events. For the first quarter of 2017, Biogen generated revenues of $2.8 billion, a 3% increase from the same period a year ago. On an apples-to-apples basis, when we exclude all hemophilia revenues from both period, we grew revenues 8% from the same period a year ago. GAAP earnings were $3.46 a share, a 22% decrease from the same period a year ago, driven by the charge we took related to our settlement and license agreement with Forward Pharma which Paul will discuss later. Non-GAAP EPS was $5.20, a 9% increase versus the same period a year ago. Excluding hemophilia, non-GAAP EPS growth will have been even higher. I am pleased with our results and achievement this quarter. Let me highlight what we think are the key takeaways for the quarter. First, financial performance. We…

Michael D. Ehlers, M.D., Ph.D. - Biogen, Inc.

Management

Thank you, Michel, and good morning, everyone. Let me start with some broad comments on the evolution of Biogen R&D. I am extremely excited about how we're becoming more entrepreneurial. Our approach is to blend strong science with a medical mindset and an entrepreneurial emphasis on innovation. We will be agnostic to whether we find innovation internally or externally. The goal is to continue our tradition of applying our deep scientific expertise as we aim to discover and develop the very best medicines for patients. We're laser focused on neuroscience and value creating adjacencies. I believe this makes abundant sense and positions Biogen uniquely in this breaking area to leverage our leadership in multiple sclerosis, to capture broad opportunities in neuroscience. There is arguably no bigger area of unmet medical need than diseases of the nervous system, and I believe Biogen has a tremendous competitive advantage to be the leader in this space. The genetics of neurological disorders has exploded yielding critical insight into new therapeutics and we can now measure and monitor disease states of the brain with unprecedented precision. We believe the SPINRAZA experience provides a glimpse of the future for targeting severe neurological disease and we aim to capitalize on this changing paradigm. I'm now going to walk you through the significant progress we made this quarter advancing, prioritize and building out our pipeline. Like the amyloid pathway, we believe tau pathology is central to Alzheimer's disease and other neurodegenerative disorders. Similar to our investments in a-beta antibodies and base inhibition, our commitment to tau is strong. Earlier this month we expanded our portfolio beyond BIIB076 in our preclinical anti-tau, antisense oligonucleotide with Ionis by entering into a licensing agreement with Bristol-Myers Squibb for an advanced tau asset BMS-986168 as Michel mentioned. This new antibody is aimed…

Paul J. Clancy - Biogen, Inc.

Management

Thanks, Mike. Our GAAP diluted earnings per share were $3.46 in the first quarter. GAAP EPS was negatively impacted by $1.22 related to the settlement and license with Forward Pharma in the U.S. PTO ruling in favor of Biogen in the interference proceeding. Our non-GAAP diluted earnings per share were $5.20 in the first quarter, an increase of 9% versus prior year. Total revenue for Q1 increased 3% year-over-year to approximately $2.8 billion. Excluding hemophilia revenues from both periods, total revenue grew 8%. Global first quarter TECFIDERA revenues were $958 million. This included revenues of $751 million in the U.S., an increase of 1% versus Q1 last year, and $207 million outside the U.S., an increase of 3% versus Q1 last year. On a sequential basis, U.S. TECFIDERA revenues were negatively impacted by approximately $50 million to $60 million due to lower levels of inventory at the specialty pharmacies. Interferon revenues, including both AVONEX and PLEGRIDY were $648 million during the first quarter, a decrease of 3% versus Q1 last year. This included $465 million in the U.S. and $184 million in sales outside the U.S. TYSABRI worldwide revenues were $545 million this quarter, an increase of 14% versus Q1 last year. This included $306 million in the U.S. and $239 million outside the U.S. Outside the U.S., Q1 TYSABRI revenue benefited by approximately $45 million, due to reaching an agreement with the price and reimbursement committee of the Italian National Medicines Agency related to prior periods. SPINRAZA revenues for Q1, its first full quarter on the market, were strong as we reported $47 million. SPINRAZA U.S. revenue was $46 million. This represents very strong underlying demand combined with some natural inventory build as the launch ramps. We estimate that less than $10 million of the SPINRAZA revenue was due…

Michel Vounatsos - Biogen, Inc.

Management

Thank you, Paul. I will venture to say that 2017 is off to a strong start for Biogen, but we have much more to do. We are refocusing the organization and I am building my management team. We are all energized and are working to develop the strategy and priorities for both short-term and long-term shareholder value creation. We plan to update you on our progress when we report our second quarter earnings in July, but we do not wait with obvious actions to be taken to support Biogen in terms of R&D, BD and commercial. Our actions will speak for themselves. For July, we hope to provide you with clarity on our priorities and plan. I aim to communicate a clear picture of the Biogen of tomorrow, a company that can meaningfully improve patients' life in the increasingly important field of neuroscience through new, innovative therapies and create long-term sustainable value for our company and our shareholders. And I believe strongly that this is the new Biogen, a clear leader in a well-defined and fast-growing space. We do tackle big challenges. We are laser focused on execution and we aim to deliver strong results. In closing, I'd like to thank our employees around the world who are dedicated to making a positive impact on patients' lives, and all of the physicians, caregivers and participants in our clinical development programs. The past and future achievements could not be realized without their passion and commitment. With that, we'll open the call for questions.

Operator

Operator

As a reminder, please limit yourself to one question. Your first question comes from the line of Eric Schmidt with Cowen and Company. Please go ahead. Eric Schmidt - Cowen & Co. LLC: Oh, good morning. Congrats on the fine launch for SPINRAZA and the overall quality of Q1 results as well. My question's on SPINRAZA. I guess we've gone, in the last three months, from thinking the launch would be gradual to today calling it robust. So what's going better than you expected? Is it access to reimbursement or your ability to work through the logistical issues at the centers or greater urgency to treat, greater demand? Please comment. Thanks.

Michel Vounatsos - Biogen, Inc.

Management

So a couple of months ago, and since the beginning actually – this is Michel – we did identify two bottlenecks. And number one was infrastructure due to the intrathecal therapy injection modalities that were not performed into the SMA northern (33:30) neuromuscular centers, and in addition, the insurance coverage. Those two bottlenecks remain and they will be also relevant for the other markets where we're going to launch SPINRAZA hopefully soon. Having said that, motivated families, patients, parents, advocacy groups, a professional team at Biogen, dedicated providers, the leadership of the hospital and the providers were able to accommodate, not as a linear fashion, some bigger centers with a certain pattern, smaller centers eventually with more speed and flexibility, one size does not fit all. But all in all, this is where we stand today.

Operator

Operator

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

Geoffrey C. Porges - Leerink Partners LLC

Analyst · Geoffrey Porges with Leerink Partners. Please go ahead

Thanks very much, and share my congratulations on SPINRAZA. Could you give us a little bit more detail on the MS business, particularly the contribution of price and volume in the U.S. for the brands there, and comment on price? Previously you'd said that you anticipated taking one price increase a year. Is that still the company's view? And is that something that we should continue to plan for the balance of the year? Thanks.

Michel Vounatsos - Biogen, Inc.

Management

So in the U.S., that remains our largest and stable market for which we remain fully dedicated to continue to improve the picture. First of all, on the market dynamic, if you recall well, I did mention that in 2016 we saw a slight contraction of the market in terms of commercial goods versus the prior period. Well, we did see that sustain during Q1 versus Q4 of 2016, probably, and by a few percentage, nothing dramatic. One of the reason might well be that there was a bit of warehousing due to OCREVUS. I don't know by facts, but this might be a reason. All in all, the assumption within the company is that the market will return to low-single-digit market growth for the remainder of 2017. For Biogen business, a very strong defense of our performance. And actually, I am pleased by the momentum I see in a slightly declining market of our NTRx and TRx shares and you can have a look into those. I think that TECFIDERA defended very well, TYSABRI rebounded. Overall, Biogen is holding very strong and we continue to see a slight erosion of the interferons as expected. So all in all I will say a good performance that I want to see improved. Capture rate is holding very well, slightly improving. Discontinuation due to TEC GI did not really improve and I'm not satisfied by that. But I do not give up. So we are working hard to improve on this figure. But all in all, I will say it's very solid engagement while the team has the plate full of tactical plans in order to be ready for an increased competition while we speak.

Paul J. Clancy - Biogen, Inc.

Management

And then, Geoff, this is Paul. Just second part of your question, we understand it's an important question, and I know we've commented in the past, but we're not going to comment on any kind of perspective of forward pricing in the MS market.

Michel Vounatsos - Biogen, Inc.

Management

If I may add just a small comment on this important dynamic that we see in the marketplace, is that Biogen has the opportunity to benefit from a complete portfolio in MS, and we are working very hard. And if we want to change the landscape, we need to move away and try to progress on value-based and innovative type of contracting. It's difficult. The team is making some progress, but today I have nothing to report except that some progress and some discussion with different PNs. So we are working on this dimension.

Operator

Operator

And your next question comes from the line of Geoff Meacham with Barclays. Please go ahead.

Geoff Meacham - Barclays Capital, Inc.

Analyst · Geoff Meacham with Barclays. Please go ahead

Morning, guys. Thanks for the questions and also want to give my congrats on the quarter. Michel, you talked about filling out the pipeline more and with the launch of anti-tau, are you comfortable with the number of assets or mechanisms that you have in the Alzheimer's portfolio? And is it reasonable to assume that biz dev may be neurology focused or is it likely that you guys will look more broadly at the orphan space just given the SPINRAZA launch? Thank you.

Michel Vounatsos - Biogen, Inc.

Management

Thanks for the question. I'll get started, and obviously, Mike will comment more thoroughly. First, I would like to say that I'm very pleased that Biogen was able to pull it in a very competitive setting. Anti-tau is an important mechanism that complements well via all the programs we have with the same target, but also the a-beta assets that we have with aducanumab at the forefront and the BACE inhibitor that we have partnered. So these positions, Biogen's I will say pretty well in AD and Mike will complement. We continue to work hard and we are doing that in order to improve the footprint of our phase early stage which is a sweet spot on where we can add much value with the development. Biogen's, at Biogen neuroscience is dimension in life, and this is where we can add most of the value with meaningful development because we have great people, great team. And the partners see that. So before we move beyond, we're looking to neuro space. And in the neuro space, we look first at MS, SMA and neurology. Mike?

Michael D. Ehlers, M.D., Ph.D. - Biogen, Inc.

Management

Yeah. Thanks, Geoff, for the question. On the tau side, I'd say we're very excited now to have this more advanced tau antibody in the portfolio. And as I'd mentioned, we've got an earlier second antibody, BIIB076 and in our collaboration with Ionis, an antisense oligonucleotide against tau which we're looking to advance to the clinic in the coming months. So we're quite excited about that. Michel said it well. We're really concentrated in neuro as an area. I'd say when you look across the opportunity landscape externally, we really try to focus on things that are in the early clinical asset space. That's kind of our core, where we believe that we can identify things with a bit of asymmetric knowledge and apply some asymmetric capabilities to that. We don't exclude other areas, but that's just where we're concentrated. So if we see a good opportunity that's a little bit later in a more adjacent area or even something that's earlier, we're quite open to it. On the question around more orphan diseases or other things, I think that the experience with SPINRAZA highlights to us the real potential advantage of intrathecal ASOs as a modality. We've got an early Phase 1 ongoing study in SOD1 mutant ALS as just another example of that. So we see great opportunity in that intersection between neuroscience and certain orphan diseases.

Operator

Operator

And your next question comes from the line of Umer Raffat with Evercore. Please go ahead.

Umer Raffat - Evercore Group LLC

Analyst · Umer Raffat with Evercore. Please go ahead

Hi, guys. Congrats on the SPINRAZA launch. So, since I was totally off on my end, I thought I'd ask you how to understand SPINRAZA numbers some more. So Paul, thank you. You mentioned it was about less than $10 million worth of inventory of the $46 million in U.S. So that would imply $36 million in sales or perhaps something like 360 infusions. So I guess what I'm trying to understand is if there were 30 centers enrolled as of early March and 88 centers as of April 21, that implies most of the patients have probably not had more than three infusions. So is it unreasonable if I were to say 360 divided by 3, perhaps about 120 patients on therapy as of Q1? And I'm partially doing that to understand if there's a spillover into 2Q or not. And maybe one, just a quick one on R&D. Just wanted to understand the significance of the midway enrolled on aducanumab Phase 3. Does the protocol enabled an interim analysis of sorts on week 52 or week 76 for these first 1300 patients? Thank you.

Paul J. Clancy - Biogen, Inc.

Management

Umer, this is Paul. Let me kind of do a couple things. One is the inventory, I know it was important for every – on SPINRAZA was important, but it literally is a triangulation of data. So I wouldn't – it's not as precise as our knowledge of kind of the inventory on TECFIDERA in the specialty pharmacy channel, but it is our best estimate at this time that it's something in the less than $10 million range. And while we have a closed system on SPINRAZA, sometimes the patient data lags and we're estimating things along the way. No doubt as we move through Q1 the patients began to ramp and the dosing schedule, as you point out, the loading dose schedule does likely have some level of spillover effect. But I think that's kind of small dynamics and broadly what we're trying to do is get patient access and get through the infusion capacity constraints, get through the access constraints, get as many patients across all the different types of SMN patients on therapy.

Alfred W. Sandrock - Biogen, Inc.

Analyst · Umer Raffat with Evercore. Please go ahead

And Umer, this is Al, on the aducanumab question. We have a policy here that we're not talking about interim analyses. I'm afraid I can't answer that question.

Operator

Operator

And your next question comes from the line of Ronny Gal with Bernstein. Please go ahead.

Ronny Gal - Sanford C. Bernstein Limited

Analyst · Ronny Gal with Bernstein. Please go ahead

Good morning, everybody, and thank you for taking my question. I'm going to stick with nusinersen. First, do you have any better feel right now for how long the effect of nusinersen is? Given that we kind of are done with the question of the early launch, the question now is how long can you actually keep those patients alive and therefore, what should we model for those product's accumulation of patients long-term? And second, you've mentioned that you're about to take your gene therapy into the clinic. I guess the question is what is the differentiation of your program versus the existing gene therapy which is already in the clinic? What are you doing better than they that will allow you to differentiate versus their product?

Michael D. Ehlers, M.D., Ph.D. - Biogen, Inc.

Management

Okay. Ronny, this is Mike. I'll start with that a little bit. On the question of SPINRAZA durability, I guess what we can say is that we started the first patient dose just about five years ago, and from what we've seen for that, there's been, essentially, sustained effects with those patients to date. There's a lot that's not known here. Obviously, this is kind of an ongoing clinical experiment and many of these patients are being rolled over into an open label kind of observation period for this. So the fact is, is that we just don't know what ultimately the durability would be, but everything that we've seen is a durable effect of continued dosing of SPINRAZA. So I'd say on that, on the gene therapy side of this – so there are a lot of things. One is we're very encouraged by the gene therapy data that is out there, of what AveXis has publicly reported. We are quite bullish in general on the modality of AAV-based gene therapy. We do believe that there's the prospect for differentiation in terms of tissue tropism, serotype, delivery routes, dosage, viral load, manufacturing, and so forth. So we think there's ample room for differentiation and time will tell. The other thing we would say is we believe that there can be a future out there where these are used in combination in certain settings that will depend very much on the stage and type of SMA.

Operator

Operator

And your next question comes from the line of Cory Kasimov with JPMorgan. Please go ahead.

Cory W. Kasimov - JPMorgan Securities LLC

Analyst · Cory Kasimov with JPMorgan. Please go ahead

Hey, good morning, guys, and thanks for taking my questions. Just curious, what are the qualifications for the free drug program for SPINRAZA? And do you anticipate the 25% of units flowing through now will kind of remain the steady state going forward?

Paul J. Clancy - Biogen, Inc.

Management

Ronny (sic) [Cory] (47:23), this is Paul. Good. Thanks for the question. It's kind of tied up in if there's denial, effectively. There's obviously also some normal, as you would expect, income for people that can't afford it. With respect to the kind of free goods, I think that is an estimate that we won't know until we get much farther, and I would guess it wobbles quarter to quarter. I mean, it even wobbled within the quarter, so I think it wobbles around a little bit quarter to quarter as well.

Operator

Operator

And your next question comes from the line of Ying Huang with Bank of America Merrill Lynch. Please go ahead.

Ying Huang - Bank of America Merrill Lynch

Analyst · Ying Huang with Bank of America Merrill Lynch. Please go ahead

Hey, morning. Thanks for taking my questions. Specifically maybe Mike, can you comment on what's the difference between BIIB076, your anti-tau antibody that just entered Phase 1 and then the anti-tau antibody license from Bristol-Myers, what really caused the decision to out-license that compound? And then secondly, maybe, I think, Michel, you commented on roughly half of the Medicaid plans now cover SPINRAZA. Can you provide any color on what's the percentage of commercial plans that cover SPINRAZA now? Thank you.

Michael D. Ehlers, M.D., Ph.D. - Biogen, Inc.

Management

Okay, Ying, so I'll start with that. Thanks for the question. A few things, the reason we like – I mentioned about how we just in general see intersecting tau as a very important feature of neurodegenerative disease including Alzheimer's disease. I'd say three or four core things. One, it was a more advanced clinical stage asset that was of interest. Two, it was really quite clear that you had a very potent antibody here where they had generated a very compelling biomarker data in terms of robust lowering of CSF tau. There'd been more clinical experience and a known kind of benefit/risk profile that had been seen in many patients to date, as you would expect from a more advanced clinical asset. And then it also gave us this kind of accelerated opportunity in progressive supranuclear palsy as another very exciting indication for us.

Paul J. Clancy - Biogen, Inc.

Management

Ying, this is Paul. Let me kind of try to tackle the second part of your question in terms of coverage on SPINRAZA in the commercial plans. Our estimate is that about 75% plans that cover the lives across the United States have coverage and approved SPINRAZA. Of that, about half of those have a narrow, call it Type 1 type coverage and about half of those have broad coverage. Importantly, as Mike pointed out, we'll be presenting data tonight that will hopefully start to get a more broad coverage as well.

Operator

Operator

Your next question comes from the line of Joshua Schimmer with Piper Jaffray. Please go ahead. Joshua E. Schimmer - Piper Jaffray & Co.: Great. Thanks so much for taking the question. Can you please estimate the size of the SPINRAZA patient backlog? And do you believe you can address infrastructure bottleneck issues so that it's no longer a gating step by end of the year? And then for Europe, how are you handling this so it doesn't slow launch there, too? Thank you.

Paul J. Clancy - Biogen, Inc.

Management

Yeah. Josh, actually we'd prefer not to. We obviously have internal data on start forms and we have a sense for that, but we'd prefer not to because I just don't know the accuracy of it all at this point in time. With respect to Europe, we are effectively have been putting pre-launch efforts in place on a country by country basis, prioritizing, obviously, those countries that we expect to get reimbursement earlier as opposed to later. So tremendous amount of energy in Germany, energy in the Nordics, energy actually also in UK for some relatively unique circumstances. And I think it's going to be a very similar dynamic with respect to trying to accommodate and get through infusion capacity.

Michel Vounatsos - Biogen, Inc.

Management

If I may add very briefly, I am monitoring very closely the ability of the organization to implement and to execute, being for SPINRAZA, and I think that the data to date speaks for itself, and we'll continue to do the same in Europe with the individual regulators to follow up following the CHMP endorsement with a broad label and including reimbursement. So we'll get started hopefully we believe this summer with Germany and Scandinavia with an access condition. And we have an early access program with more than 300 patients. And gradually the countries will come with market access condition one after the other. And it's all about execution from the Biogen team, it's execution on SMA, execution on biosimilar and execution obviously on MS. I just want to reiterate that for TECFIDERA, we are working very hard. TECFIDERA is now the market – is growing share in 17 out of 21 markets in Europe, okay? Germany is growing share six months in a row. We have hit within France the highest ever share for TECFIDERA. So it's all about the ability for the team to implement well with what we have in the bag in the portfolio today in a very focused manner and the right way.

Operator

Operator

And your next question comes from the line of Salim Syed with Mizuho Securities. Please go ahead.

Salim Syed - Mizuho Securities USA, Inc.

Analyst · Salim Syed with Mizuho Securities. Please go ahead

Hey guys, congrats on the quarter. Just two questions. Paul, I think both of these are for you. You mentioned OCREVUS having a negative impact. Can you just go into a little bit more color there? And what products in particular do you see OCREVUS impacting? Is it mostly TYSABRI, or do you think it's TECFIDERA? And then second, just on SMID-cap valuations, it sounds like now you guys are approaching M&A a little bit more aggressively. Paul, can you maybe comment on your thoughts on SMID-cap valuations at these levels? Thank you.

Paul J. Clancy - Biogen, Inc.

Management

Yeah, let me take the second one first. I mean, no comment that one. So, I mean, I have points of view on it, but we obviously don't talk about it. It's kind of like one step away from talking about names. Look, OCREVUS, we've done a lot of work on it. Again, we do think a new entrant that has an interesting profile for patients and physicians will get a place in the marketplace and inevitably as we have plus or minus 40 share across our existing portfolio of products, there'll be an impact on that. We think that OCREVUS plays in the high efficacy segment. And as a result, the likelihood is that it impacts TYSABRI vis-à-vis the products in our portfolio more than others as well. There's a chance it impacts TECFIDERA as well. We think that the platform therapies inclusive of AVONEX and PLEGRIDY are the least impacted. All of that is obviously a total forecast and we're going to be monitoring it very closely as we move forward. And, look, this is not a surprise, right? So I think that I would characterize it as similar to way Michel has characterized it as that the best thing that we can do is just simply continue to really put forward the strength of our own products and we have a great, great suite of products across a bunch of different kind of segments and kind of patient needs in the marketplace. And then certainly in the United States, we're heartened that we're somewhat hedged from the royalties that are gained from OCREVUS.

Michel Vounatsos - Biogen, Inc.

Management

If I can just briefly add to what Paul rightly said, towards the higher end of the spectrum, I reinforce that, at least at the beginning, patients with high level of the (56:06) positivity that have to be switched, and this is a good thing, and obviously the PPMS, for which we'll get a benefit. So this is what we see, this is the very early days. The label is in line with what we did assume. We are monitoring very closely but we are monitoring more our assets than the competition.

Operator

Operator

And your next question comes from the line of Alethia Young with Credit Suisse. Please go ahead. Alethia Young - Credit Suisse Securities (USA) LLC: Hey, guys. Thanks for taking my question. Congratulations on the SPINRAZA launch. Just one around the S1P class in general. I know Celgene has a drug, ozanimod, and you've talked about potentially going forward in partnership, but what do you think makes for a differentiated S1P1 in general? I know you had experience with Mitsubishi as well. Thanks.

Michael D. Ehlers, M.D., Ph.D. - Biogen, Inc.

Management

So I will start with that just to say that, I don't know that we're going to really comment that much around...

Michel Vounatsos - Biogen, Inc.

Management

I think it's a good question for Celgene.

Michael D. Ehlers, M.D., Ph.D. - Biogen, Inc.

Management

Yeah, exactly. I think that's right.

Paul J. Clancy - Biogen, Inc.

Management

Yeah.

Operator

Operator

Your next question comes from the line of Terence Flynn with Goldman Sachs. Please go ahead. Terence Flynn - Goldman Sachs & Co.: Hi, thanks for taking the question. Was just wondering on SPINRAZA if you can give us any color on the percentage of new starts versus rollover patient. And then I noticed there was an uptick in cost of goods this quarter. Paul, was there anything notable there or is that going to trend down over the rest of the year? Thanks.

Paul J. Clancy - Biogen, Inc.

Management

Terence, thanks for the question. This is Paul. Let me try to take both of them. I think what you're referring to on SPINRAZA is with respect to rollover patients of those that were in the trial or in our EAP program. And on both dimensions, it was a very small number actually. The trial patients are continuing on in a trial. The EAP patients, because that if you recall, it was approved in such a short period of time from filing, we actually in the United States had well below 100 patients on EAP and only a handful of them actually have moved into commercial patients. So the vast majority of the sales for Q1 on SPINRAZA are due to, in effect, de novo new patient. Cost of goods sold is a bit a function of a number of things. The biosimilar business, which is growing quite strong, comes with a high cost of goods sold. We have had – the AVONEX business actually has an additional royalty that started in the second half of 2016 and when we compare it to the first half of 2016, we kind of have unfavorable comps. So I think that's indicative probably of what we're going to see over the next number of quarters.

Matthew Calistri - Biogen, Inc.

Management

And Dan, we're going to have time for one more question.

Operator

Operator

And our final question comes from the line of Matthew Harrison with Morgan Stanley. Please go ahead. Matthew K. Harrison - Morgan Stanley & Co. LLC: Great. Thanks for fitting me in. I appreciate it. I just wanted to try and sort of group together sort of all the comments you've made on SPINRAZA and just try and understand sort of a broader question, which is obviously there are some of these dynamics that you've talked about including insurance and infusion which is sort of limiting some of the uptake, though you've obviously worked through that with patients. And I guess what I'm trying to understand is how should we think about if there was a bolus in this quarter and the new start rate should decline or if you still think that the dynamics you talked around insurance and infusions are still holding back a substantial portion of patients and that the new start rate should continue to increase as we think about for maybe the next quarter or through the rest of the year. Thanks.

Paul J. Clancy - Biogen, Inc.

Management

Matthew, thanks for the question. This is Paul. Quite frankly, it's hard to really tell on that, the kinetics of this. And we've said it all along, it's hard to tell. We're very pleased with Q1. I personally would expect it continues to ramp if you look at the number of patients in the United States. So you just look at the number of patients, the number of centers that still haven't, that we're still working through plans, I would. The kinetics of it – and also, we always have to keep in mind the kinetics of kind of the cohort of patients going through loading dose then moving to maintenance dose and so on and so forth. I think we'll see some level of we'll all be interpreting the data as we go quarter by quarter. But broadly speaking, I think what this really pulls out is the tremendous value of the drug in the tremendous unmet need in the patient population.

Michel Vounatsos - Biogen, Inc.

Management

And if I may just add and conclude, the two bottlenecks that we did identify at the outset remain. It's a battle every day, and we are not yet where we want to be. Some of the largest plan or the largest facilities in terms of infrastructure are still not dosing the way the patients deserves and the way the families and the advocacy group expect. So there is still a way to go, but it's unlocking and progressing week after week. I think the key element that first of all the country deserves, the patient deserves is newborn screening. The day we have that, we can really change the treatment and the evolution of SMA. And if you look at the NURTURE data the results speaks for themselves.

Michel Vounatsos - Biogen, Inc.

Management

Thank you all for your attention today.

Operator

Operator

Thank you to everyone. This will conclude today's conference call. You may now disconnect.