Earnings Labs

Biogen Inc. (BIIB)

Q4 2018 Earnings Call· Tue, Jan 29, 2019

$193.87

+5.72%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-1.98%

1 Week

+0.75%

1 Month

-0.11%

vs S&P

-6.57%

Transcript

Operator

Operator

Good morning. My name is Jack, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Fourth Quarter and Full Year 2018 Financial Results and Business Update Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] Please limit yourself to one question to allow other participants time for questions. [Operator Instructions] Thank you. I would now like to turn the conference over to Mr. Matt Calistri, Vice President, Investor Relations. You may begin your conference.

Matt Calistri

Analyst

Thank you and welcome to Biogen's fourth quarter 2018 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of biogen.com to find the earnings release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we will 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 the Risk Factors discussed in our SEC filings for additional detail. On today's call, I am joined by our Chief Executive Officer, Michel Vounatsos; Dr. Michael Ehlers, EVP of Research and Development; and our CFO, Jeff Capello. We will also be joined for the Q&A portion of the call by our Chief Medical Officer, Dr. Al Sandrock. Before I conclude, I would also like to remind everyone, that we now post releases related to earnings calls and Investor Events on the Investors section of Biogen's website, www.biogen.com. And issue a statement on Twitter when they become available. We do this instead of publishing earnings releases and any releases related to Investor Events and earnings calls via Newswire services. Our Twitter handle is @biogen. Now, I will turn the call over to Michel.

Michel Vounatsos

Analyst · Barclays. Your line is open

Good morning, everyone, and thank you for joining us. First let me start with some financial highlights. Biogen closed 2018 with an all-time high in quarterly revenues of $3.5 billion, an increase of approximately 7% compared to the same period a year ago. For the full year 2018, Biogen generated another all-time high of $13.5 billion in revenues, representing growth of 10% year-over-year. Full year 2018 GAAP earnings were $21.58 a share, an 81% increase versus full year 2017. Full year 2018 non-GAAP earnings were $26.20 a share, a 20% increase versus full year 2017. We are pleased with this strong year-over-year growth as we continue to execute on our strategy to solidify our long-term leadership position in neuroscience. Now, let me review the year. First, full year MS revenues including OCREVUS royalties were $9.1 billion demonstrating resilience. The number of patients on our MS products globally remained relatively stable versus the prior year. Importantly, we continued to see improving trends for our MS business in the U.S. on a year-over-year basis. Second, SPINRAZA, which we pioneered in collaboration with Ionis as the first treatment for SMA, generated full year global revenues of $1.7 billion, and nearly double the revenues we delivered in 2017. This blockbuster performance was driven by strong year-over-year revenue growth in the U.S. and even greater revenue growth outside of the U.S. Over the past year, including the expanded access programs and clinical trials, we have more than doubled the number of patients on SPINRAZA to over 6,600 patients. SPINRAZA is the standard of care in SMA with approval in over 40 countries and formal reimbursement in 30 countries. Third, we continue to expand and progress our neuroscience pipeline with strong momentum, building depth in our core growth areas. We are leveraging the interconnectivity within neuroscience…

Michael Ehlers

Analyst · Terence Flynn with Goldman Sachs. Your line is open

Thank you, Michel, and good morning, everyone. Neuroscience is experiencing a revolution in science and medicine. There is no a large area of unmet needs and disease in the nervous system, and we believe that our focus on neuroscience offers a key strategic advantage. Before I discuss our pipeline in more detail, let me comment on our recent progress on building a multi-franchise neuroscience portfolio, supported by a broad range of therapeutic modalities. Complementing our expanded collaboration with Ionis delivers their antisense oligonucleotide platforms. Earlier this month, we announced a strategic set of collaborations with C4 Therapeutics and Skyhawk Therapeutics to discover and develop novels, small molecule approaches for neurological diseases. Our collaboration with C4 Therapeutics, we utilize C4's platform to discover small molecules and engage the endogenous ubiquitin–proteasome system to selectively tag disease-causing potential for degradation. And through our collaboration with Skyhawk, we aim to discover small molecules capable of modulating RNA splicing at selective pre-messenger RNAs, including SMN2. With these collaborations, we have further expanded the breadth of modalities we are pursuing, which now includes biologics, antisense oligonucleotide, oral protein degraders and splicing modulators and gene therapy. As Michel discussed, looking over 2018, we added six clinical programs to our pipeline and transitioned five pipeline candidates from research to development. The same number as the previous year, which nearly doubled Biogen's historical productivity. Thus, once again, 2018 represented a substantial enhancement of our differentiated clinical portfolio of potential breakthrough medicines. Turning to advances in the fourth quarter. Let me start with the depth, we are building in neuromuscular disorders. Last month, we, along with our partner Ionis, received data from an interim analysis of the Phase 1 study of BIIB067 in the form of familial ALS. BIIB067 is antigens oligonucleotide, targeting superoxide dismutase 1 or SOD1, mutations in…

Jeff Capello

Analyst · Chris Raymond with Piper Jaffray. Your line is open

Thanks, Mike. Good morning, everyone. Let me now provide some detail on our financial performance for 2018 and share with you our guidance for 2019. Let's start with revenues. As Michel mentioned earlier, we had a strong Q4 2018 from a revenue perspective. Total revenue for the fourth quarter grew 7% year-over-year or approximately $3.5 billion and grew 10% for the full year to $13.5 billion. Overall, our MS business delivered revenues of $2.3 billion in the fourth quarter of 2018, including OCREVUS royalties for approximately $152 million. MS revenues in the fourth quarter of 2018 decreased 1% versus the prior year without OCREVUS royalties and increased 2% including OCREVUS royalties. In the U.S. MS revenues in the fourth quarter 2018 benefited from channel inventory build for approximately $115 million, compared to a build of approximately $15 million in Q4, 2017. Our U.S. business continued to show signs of stabilization in the fourth quarter, continuing the trends of improving year-over-year performance we saw throughout 2018. Full year MS revenues were $9.1 billion including OCREVUS royalties of approximately $478 million, representing a decrease of less than 1% versus the prior year. Excluding OCREVUS royalties, MS revenue decreased 4% versus the prior year. Full year 2018 MS revenues benefited by approximately $86 million versus the prior year due to changes in foreign exchange rates, net of hedging. Global fourth quarter TECFIDERA revenues were $1.1 billion, a 3% increase versus the prior year. This included revenues of $856 million in the U.S., an increase of 3% versus the fourth quarter 2017 and $254 million outside the U.S., an increase of 4% versus the fourth quarter of 2017. TECFIDERA benefited from increase in channel inventory in U.S. of approximately $65 million in the fourth quarter 2018 compared to an increase of approximately $40 million…

Michel Vounatsos

Analyst · Barclays. Your line is open

Thank you, Jeff. We closed 2018 with strong commercial performance, double-digit earnings growth versus a year ago and strong execution of our strategy. We opened 2019 with the announcement of two business development deals. We have enhanced our neuroscience pipeline and broaden our capabilities across multiple modalities as we prepare for multiple upcoming important readouts. Biogen's vision and strategy are clear. As a pioneer, we aim to capture the significant unmet medical need in neuroscience with a goal of bringing potential new therapies faster and more efficiently to patients. For 2019, we aim to continue our momentum and achieve our guidance. To deliver on our aspirations, we remain focused on executing well on our strategic priorities to fortify our core business in MS and SMA. And also, allocate capital to expand and progress our neuroscience pipeline while opportunistically returning capital to shareholders. Biogen will continue to actively pursue business development and M&A. Within the next 12 to 18 months, we expect further progress as we aim to build a multi-franchise neuroscience portfolio including data reduction Alzheimer's, including the final Phase 3 data for aducanumab as well as MS and PSP. Up to five new assets advancing into the clinic and potentially regulatory approval in the U.S. for VUMERITY in MS. Finally, I want to reiterate our commitment to maximizing return to our shareholders and bringing innovative strategies to patients over the long-term. These demands that we continue to allocate capital efficiently, effectively and appropriately. As we have demonstrated in the past, we will always strive to have an optimal capital structure as well as aim for superior return from the investment we make. Once again, I would like to thank our employees around the world, who are dedicated to making a positive impact on patient’s life and all of the physician, caregivers and participants in our clinical development programs, our past and future achievements could not be realized without the passion and commitment. With that, we will open the call for questions.

Operator

Operator

Certainly. [Operator Instructions] Your first question comes from the line of Geoff Meacham with Barclays. Your line is open.

Geoff Meacham

Analyst · Barclays. Your line is open

Hey, guys good morning. Thanks a lot for the question. Michel, when I look at 2019 guidance, it reflects a slower growth profile for both revenue and earnings. So, the question is from a strategy perspective, does this alter your view on BD, your capital allocation, or do you look at 2019 growth as more of a temporary trend? And then Mike or Al, real quick, I just wanted to ask you guys on the new Phase 3 study for aducanumab in earlier stage Alzheimer's. Was this informed at all from ENGAGE, EMERGE or PRIME or something else? Thanks.

Michel Vounatsos

Analyst · Barclays. Your line is open

Thanks for the good questions. So, the strategy as you know is clear and simple and very usable. There’s three main reasons to believe; first, we have a strong underlying momentum, solid base, value proposition, improving with the offer of biosimilars and we are working on the operating model. Second, we have a strong and stronger engine for growth with all the enhanced pipeline that Mike spoke about, and we have very important landmark study readouts in the coming period, so this is a very exciting place to be. Third, we have financial strengths. So concerning the BD and M&A, the drive first will be to continue to accelerate the buildup of our modalities and pipeline. This will be the key driver, scientific and strategic alignment. We will not go for bridging a potential gap because we are not on a burning platform. The team is building up very well; the management team is spending a lot of time on those activities. We have a broad range of targets and we are working on that but with pace and calm.

Al Sandrock

Analyst · Barclays. Your line is open

So, hi Jeff, this is Al. On your second question, we've been considering doing this preclinical study, we call it, for a few years now and it's part of our broader life cycle management strategy. I'd say the reasons why we're doing it are that many of our advisors and investigators have been encouraging us to do it for some time, and I would say also that the BAN2401 results that we got roughly six months ago increases our level of confidence in aducanumab, and then finally as you know FDA put out guidance recently that contemplates how you might get approval for early AD. So we believe one day, the standard of care will be to treat with amyloid-lowering drugs as early as possible and this trial will go a long way toward informing that.

Operator

Operator

Your next question comes from the line of Michael Yee with Jefferies. Your line is open.

Michael Yee

Analyst · Michael Yee with Jefferies. Your line is open

Thanks, good morning. Congrats on the good quarter. I know everyone is focused on interim analysis, so I’m asking if there will be an interim analysis on aducanumab? Just asking actually, it feels like the street would like to know if you had one or if you had a futility analysis whether that would be disclosable if you passed either of those? I think Roche talks about the futility and how that's a material piece of information, so I just wanted to understand your view on whether you took either of those of if they will be on futility and whether that’s disclosable? Thanks so much.

Al Sandrock

Analyst · Michael Yee with Jefferies. Your line is open

Mike, this is Al. I am really sorry, but we continue to have a policy here that we don't talk about interim analysis.

Operator

Operator

Your next question comes from the line of Terence Flynn with Goldman Sachs. Your line is open.

Terence Flynn

Analyst · Terence Flynn with Goldman Sachs. Your line is open

Hi. Thanks for taking the question. With respect to SPINRAZA ex-U.S, I was just wondering if you can give us a little bit more detail on the impact in the fourth quarter from pricing versus loading dose, and then maybe help us think about the pacing going into 2019? And ex-U.S. reimbursement progress, any new countries that you guys are expecting to come on board in 2019? Thanks.

Michael Ehlers

Analyst · Terence Flynn with Goldman Sachs. Your line is open

Thanks for the question. So just to reiterate, we're very pleased with the performance of SPINRAZA, both in the U.S. and outside the U.S. and think it has a very strong growth profile. It was up 60% year-over-year although down a little bit sequentially. As I mentioned, really there are three factors that drove the sequential decline and that was; one, a shift from loading to maintenance doses in some of the more mature markets in Europe, the timing of shipments in certain distributor markets which are hard to predict, and then pricing dynamics including unfavorable country mix. So as we look forward in 2019, we expect for that franchise to resume growth. We expect that to come from several sources. Number one, in the mature markets, just like we saw the dynamic of the shift in the U.S., we expect some of these larger markets to return to growth in 2019. Second, although the IPM, or International Partner Markets, will continue to be lumpy, they are a good source of growth for us, so we expect that to grow as well. And then if you look at new markets, either entry into new markets for expansion into markets that we've just recently entered, there's a number of kind of interesting things that are happening. If we look at Europe first, we expect to enter the U.K. at some point in 2019 which would be a good size opportunity. In Turkey, we've been very successful in Type 1. We expect to kind of get Type 2 and Type 3. Saudi Arabia, Poland, and Portugal are all markets we expect to enter as well from a European perspective. Moving around the world, Canada, we just recently got approval in the fourth quarter of 2018. We expect that to be a good growth opportunity for us and a good market. And then, if you look across the rest of the world, in Asia Pacific, South Korea, we expect to get reimbursement in that market in 2019. Taiwan is another good sized market, Hong Kong. And then, in China we expect to get in on a self-pay basis. And then, Latin America, Brazil could be a sizable country. Today it's on a one-off approval basis. We expect to get reimbursement from the epidemiology is in the thousands in Brazil. So there's ample opportunity for us to grow. It's diversified regionally and by country. That's a real testament to both the effectiveness and reception of SPINRAZA worldwide.

Michel Vounatsos

Analyst · Terence Flynn with Goldman Sachs. Your line is open

So we expect to grow SPINRAZA during 2019 in the U.S. and ex-U.S. Remember, in the U. S. one year ago we're not sure by the ability of the organization to penetrate the large adult segment of the prevalence and we add 15%. This has driven more than 50% of the new starts in Q4. There is still a very long way to go. The organization is ready, working on that and beyond the U.S. just give some color.

Operator

Operator

Your next question comes from the line of Geoffrey Porges with SVB Leerink. Your line is open.

Geoffrey Porges

Analyst · Geoffrey Porges with SVB Leerink. Your line is open

Thank you very much and I appreciate all the information on the call. I had a question on BIIB067. Mike, could you talk a little bit about the data? When we might see it? Whether you've had a chance to discuss it with the FDA? The size of the cohort? And how quickly this could advance? You seem quite excited about the signal. And then, perhaps you could just address what the general principles you take away from this finding are for the rest of your program? Thanks.

Michael Ehlers

Analyst · Geoffrey Porges with SVB Leerink. Your line is open

Yes. Thanks, Geoff, for the question. A few things, hopefully I'll touch on each of these points. We will plan to present the data at an upcoming scientific meeting. We haven't quite yet determined that, but that will be in the coming months where we'll be able to talk about it some length. We wouldn't really comment on our regulatory strategy at this point, I guess, what I would say is that we know this is a very severe disease. It's really little to nothing for these patients. So our anticipation here is that there would be good receptivity for the kind of efficacy that we think that we can see here. Just on the data itself, so this is a Phase I study, keep in mind it was designed to be a safety study as primary endpoint of this patients largely, but we incorporated a number of biomarker pharmacodynamic and clinical endpoints in this. And as I describe, it has been the collection of these both the lowering of SOD1 and the CSF has statistically significant a trend towards lowering in CSF neurofilament as well as three separate clinical outcomes, the ALSFRS, the slow vital capacity for respiratory function, the handheld dynamometry for muscle strength, and the concordance between these endpoints that have led to our excitement for these program. And I would say the general takeaways you're asking about it’s really two dimensions. One, is this is very, very encouraging to us across our ASO platform, I would say. This is our second foray after SPINRAZA. We've got many other clinical programs, new molecule as we get to the clinic. It shows us that in adult onset neurological disease we're targeting an RNase H-dependent mechanism that we are seeing signs of clinical efficacy. I believe it will be the first demonstration of proof-of-clinical concept in adults with an RNase H mechanism per se. So we're excited about that. That's one dimension. The other is that the promise that this holds broadly speaking for us in ALS, and neuromuscular disease in general.

Operator

Operator

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

Cory Kasimov

Analyst · Cory Kasimov with JPMorgan. Your line is open

Great, good morning. Thanks for taking my question. So, Al, I know you won't comment on any potential internal interim analysis. But I'm curious to get your thoughts around the expected upcoming interim readout for Roche’s crenezumab in Alzheimer's, and so far as what you see as some of the kind of the key similarities and differences between your drug and Roche’s drug? And also whether you see much of a read through to aducanumab based on these pending results?

Al Sandrock

Analyst · Cory Kasimov with JPMorgan. Your line is open

Hi, Cory. I be cautious about too much read through. First of all these are not the same antibodies, crenezumab binds to sort of a mid-domain in A-beta42 peptide, aducanumab and BAN both are in terminal. Aducanumab and BAN are highly selective for aggregated forms of A-beta both soluble oligomers as well as insoluble fibrils, crenezumab doesn't have that same level of specificity. I think it's important to note that crenezumab is an IgG4, which doesn't have full effect or function, whereas, BAN and adu both have full effect or function. And finally, we just saw the results published recently on crenezumab Phase 2 where even their high dose IV arm, they did not show statistically significant lowering of amyloid plaque whether you use subcortical white matter or cerebellum as a reference region. So that's another important difference between aducanumab and BAN, both of which show substantial reduction in amyloid plaque burden in human. So I think there are some notable differences, and I'll be cautious about too much of a read through.

Operator

Operator

Your next question comes from the line of Chris Raymond with Piper Jaffray. Your line is open.

Chris Raymond

Analyst · Chris Raymond with Piper Jaffray. Your line is open

Hey, thanks. Just a couple of financial questions. Just on the tax guidance, I think you're guiding to 200 to 300 bps lower year-on-year, and I know you cited corporate tax reform as the driver. But can you just maybe talk about the step down from 2018 or even the Q4 rate, which presumably should have benefited in tax reform? And is that number sustainable beyond 2019? And then just on the inventory, I think last year you guys had $50 million Q4 inventory build for the MS franchise. This year I think it looks like it more than double, can talk about what's driving that difference? Thanks.

Jeff Capello

Analyst · Chris Raymond with Piper Jaffray. Your line is open

Yeah, so on the tax rate, if you back up to 2017, when we -- when U.S. tax reform got passed, we dropped the tax rate about 300 basis points and at that point we said that there was a further reduction in the tax rate due to tax reform that because of the way our legal structure works from an international perspective, there was inventory that would turn to the system and that would be for the reduction of the race. So that 200 basis points is really kind of the higher simplistically think about is higher priced inventory from a tax perspective return to the system in 2018. So now in 2019 that inventory is gone, another raise is dropped. So I'm not able to kind of give you a long-term tax rate at this point. We don't know long-term guidance, but we're comfortable with the rate going down 200 basis points from 2018 to 2019. And then thereafter, it will depend on a lot of things including the distribution of earnings and other things. But for now, I think, the guidance for 2019 is something you can rely on. With regard to inventory, yes, so we built about $115 million worth of inventory in the fourth quarter compared to a build of roughly $50 million in the fourth quarter of last year, a lot of that’s outside our control. We distribute our product through distributors and they decide to either build inventory or not and we'd recognize revenue on shipment into the channel, which is different than kind of the flow through or consumption of that inventory, which is what we highlighted for people so they can normalize. So it's just beyond our control. It's not something that we have control over. So it's driven by external factors and we do our best to kind of manage through those and make sure it's clear to people in terms of what's driving demand.

Operator

Operator

Your next question comes from the line of Umer Raffat with Evercore. Your line is open.

Umer Raffat

Analyst · Umer Raffat with Evercore. Your line is open

Hi, guys. Thanks for taking my questions. First on aducanumab. My question is, and I have fully acknowledged and I don't think I ever asked about that interim. But my question is this. I realized there's a policy of not commenting on it, but once you do get a notification from the DSMB, given the sheer materiality of this, will you not put out a statement? And I guess that's really what I'm trying to get at, like, for example, trials continues as planned, like, will that happen or not happen once there is a notification to the management? And then Jeff, on inventory my question is, so the Q4 – the inventory we saw on the slide and the disclosure for last year is obviously different than the inventory numbers that were reported last year, because of the change you guys implemented in 2Q. But my question is, in 2Q that inventory slide has two different metrics and it's been a little confusing to figure out when we see the inventory disclosures now, which of those metrics are actually being reported because the numbers are different on both.

Alfred Sandrock

Analyst · Umer Raffat with Evercore. Your line is open

Umer, this is Al, I am sorry, but we just can’t comment on interim analysis.

Michael Ehlers

Analyst · Umer Raffat with Evercore. Your line is open

With regard to inventory, Umer, what we disclosed is the change within the quarter, for the beginning of the quarter to the end of the quarter, that's a number of thing we have consistently disclosed in the press releases so that is generally inventory build up by $115 million from the beginning of the fourth quarter to the end of the fourth quarter of 2018. Similarly in 2017 from the beginning of the fourth quarter of 2017 to the end, it's built by $50 million. So the change within the quarter is up $115 million in the fourth quarter of 2018 and up $50 million in the fourth quarter of 2017. So we think the relevant metric people should look at is what was the change within the quarter and if you want to know what the change was comparatively, you take the difference of the change in the change, which is $65 million I think that's pretty clear.

Operator

Operator

Your next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open.

Matthew Harrison

Analyst · Matthew Harrison with Morgan Stanley. Your line is open

Great. Good morning. Thanks for taking the question. I just want to clarify some comments you made about rebates and your outlook on the MS business, broadly can you just speak in a little bit more detail kind of like you were expecting a few hundred basis points of additional chargeback rebate pressure this year in the U.S. You thought that would be offset by OCREVUS, maybe you could just comment broadly on your outlook for the MS business in the U.S. and outside the U.S.? Thanks.

Michael Ehlers

Analyst · Matthew Harrison with Morgan Stanley. Your line is open

So I think you're referring to two different things. I think we said we expect that our discount and allowances in the U.S. take to offer another couple hundred basis points which is very similar to what happened in 2018. And that's been driven by the mix of the business becoming more Medicaid, Medicare and 340B Hospital reliant in terms of the channel it goes through where there is higher discounts. So no different than the trend we saw from 2017 to 2018. We'll see more pressure from 2018 to 2019. With regard to the performance of the MS business, I think we said that we expect that business globally to perform similarly excluding OCREVUS to what it did in 2018. And then for any difference would be made out by the OCREVUS royalties and the combination of both of those to be resilient which we kind of, say, flattish. So we expect the kind of the trends with regard to improvement to continue in the U.S., which is very encouraging and the outside the U.S. we will continue to see some pricing pressure and competition with OCREVUS rolling through Europe.

Operator

Operator

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

Ying Huang

Analyst · Ying Huang with Bank of America-Merrill Lynch. Your line is open

Hi. Good morning. Thanks for taking my questions. A quick one for maybe Al. We know that cladribine is being in the registration with FDA. I was wondering do have any thoughts on cladribine impact on the MS market? Could we see something like OCREVUS in the U.S. dynamics? And then secondly on SPINRAZA, from last quarter to this quarter your market share in infants and also in pediatrics have been stable about 50%. Do you see further growth in those two segments for SPINRAZA in the U.S. this year? Thank you.

Al Sandrock

Analyst · Ying Huang with Bank of America-Merrill Lynch. Your line is open

Hi, Ying. This is Al. On cladribine it’s -- we welcome any new therapy for MS patients, that's good for patients and good for doctors to have multiple options for their patients because MS patients are different, every one of them. Having said that cladribine, it's oral, it's very convenient in the sense that you can give it every six months essentially a cycle every six months if you will, and the key question early on was the safety, which in some of the Phase III data there were some signals that were concerning, which prevented it from being approved a few years ago, and some of those questions may still remain, which takes sort of -- which makes the convenience of it less optimal if you will. So I'll just stop there.

Michel Vounatsos

Analyst · Ying Huang with Bank of America-Merrill Lynch. Your line is open

Concerning SPINRAZA in the U.S. for infants and children if it was your question, we do believe that it is still opportunity to improve the penetration. The reason why we are 50% for infants is that some are still too advanced, and therefore they cannot be dosed. For children and toddlers, one of the challenge was the complex spine, and we can see that the clinicians are able to dose better nowadays that they have more experience. So, we should be able to continue to make reasonable inroads. The biggest potential again remains really adult, the 60% opportunity for, which we penetrated thoroughly 15% and now have the capability, the reach and the infrastructure in terms of dosing capability and coverage is establishing the U.S.

Al Sandrock

Analyst · Ying Huang with Bank of America-Merrill Lynch. Your line is open

Just as a reminder, we've got 2,600 patients in therapy in U.S. today; we estimate the total potential is 9,000. There's a lot of room to grow from perspective interest.

Operator

Operator

Your next question comes from the line of Alethia Young with Cantor Fitzgerald. Your line is open.

Alethia Young

Analyst · Alethia Young with Cantor Fitzgerald. Your line is open

Hey, guys thanks for taking my question. Congrats on the progress. I guess, I want to talk a little bit more about, what you think have been impactful in your efforts with adult, SMA, and I’ve seen that you're making some progress there. So, just wanted to get some more color on that? Thank you.

Michel Vounatsos

Analyst · Alethia Young with Cantor Fitzgerald. Your line is open

I would like to say that it starts with the team and the capability that Biogen was able to deploy in the marketplace. It takes a little bit of time for the more urgent infant population, for which we new that was a natural history the outcome of it, and the treatment centers were well identified. For the adult population, less symptomatic that can live with some symptoms but they can live quite long life. It was a bit more difficult and challenging to find treating centers and to mobilize them for a better quality of life. So this is why it took a little bit more time. So we enlarge the team, we did a lot of work in terms of medical affairs, and finally we showed that for the adult population there were incremental gains in functionality and this played a very important role. Al you want to add?

Al Sandrock

Analyst · Alethia Young with Cantor Fitzgerald. Your line is open

Yeah, I mean, many of these patients weren't seeing a neurologist anymore. They were maybe seeing rehab specialists, but they had -- since there was no treatment, they really weren't seeing neurologist even neuromuscular neurologist weren't really seeing them. But now that there is a treatment, they're starting to find doctors and the doctors -- and it turns out their neuromuscular doctors are the same ones that are treating ALS patients by the way that are now treating a SPINRAZA patients that plus the fact that interventional radiologists have gotten really good at finding ways to get into this -- into the intrathecal space when people with complex spine, spinal fusions and other things present, and so I think it's a combination of both.

Operator

Operator

Your final question comes from the line of Robyn Karnauskas with Citi. Your line is open.

Robyn Karnauskas

Analyst · Citi. Your line is open

Hi, guys. Thank you for taking my question. So, because AveXis will be launching in kids, sometime people believe early for -- some time in middle of the year, in the first half of 2019, how do you view that uptake? And do you think it's – you mentioned that some of these babies have difficulty getting the intrathecal infusions, would you think that be the area in which they'd start to take share? Or do you still believe that AVONE most likely will get a combination approach of gene therapy and SPINRAZA? I'm just trying to get a sense of when we start to see that impact, how are you thinking about that for 2019 in your guidance? And then second question was, just on the inventory draw down, so do we still expect to have all of that inventory be taken out in the first quarter? Or do you think there'll be a higher level of inventory laying around for the year? Thanks.

Michael Ehlers

Analyst · Citi. Your line is open

Okay. Robyn, this is Mike. I'll start on this and turn it over. I think our assumptions around the Novartis AVXS-101 gene therapy launch is, they've disclosed they filed in the U.S., E.U. and Japan for Type 1. Our base case is that they launch in the middle of the year and we expect that their initial label to be for Type 1 patients and mainly infants. And of course, we've been talking about it in the call, the majority of patient in Type 2 increase. So we really see this as probably being positioned for the Type 1 or the infantile SMA. Then I think the latter part of your first question was that we do think that there is opportunity for complementarity between modalities. The NURTURE data in our mind with SPINRAZA demonstrates a nearly maximal potential efficacy in terms of normal motor development if you treat in that first six-week period with SPINRAZA. That really I think sets the bar for the standard-of-care and it highlights the fact that at some level you really can't mess around on this. You've got a time window where maximal SMA protein expression really matters and I'd say the data that we’ve generated with SPINRAZA really sets the bar very high.

Al Sandrock

Analyst · Citi. Your line is open

And the with regard to your question on inventory, we would expect the vast majority of the $200 million worth of inventory would get sold through in the first quarter and then there would be none left. Although, we need to manufacturing with Bioverativ but that's completely separate – distinct from the legacy inventory.

Michel Vounatsos

Analyst · Citi. Your line is open

So for 2019 we aim to continue our momentum while we are getting ready for very important readouts. Thank you all for joining us today on our call.

Operator

Operator

This concludes the Biogen Fourth Quarter and Full Year 2018 Financial Results and Business Update Call. We thank you for your participation. You may now disconnect.