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Biogen Inc. (BIIB)

Q3 2018 Earnings Call· Tue, Oct 23, 2018

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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 Third Quarter 2018 Financial Results and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [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 · Piper Jaffray. Please go ahead

Thank, Dan. Thank you. And welcome to Biogen's third 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'm 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 call and Investor Events on the Investors section of Biogen's website, www.biogen.com. And issue 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’ll turn the call over to Michel.

Michel Vounatsos

Analyst · Evercore. Please go ahead

Good morning, everyone, and thank you for joining us. First, let me begin with some financial highlights. Compared to the same period a year ago, Biogen's third quarter revenues grew 12% to $3.4 billion, third quarter GAAP earnings per share grew 24% to $7.15 and non-GAAP EPS grew 17% to $7.40. We are pleased with this year-over-year double-digit topline and bottom line growth, as we continue to execute on our strategy to solidify our long-term leadership position in neuroscience. Now let me review the accomplishments we delivered in the third quarter. First, our MS core business including OCREVUS royalties remained stable versus prior year and delivered revenues of $2.3 billion. The number of patients on our MS products globally also remained relatively stable versus the prior year. In the U.S. we saw increasing trends for both TECFIDERA and TYSABRI on a year-over-year basis. Outside the U.S., we continued to add patients across multiple geographies. Second, SPINRAZA global revenues grew to $468 million, driven by quarter-over-quarter and year-over-year revenue growth in the U.S. and even greater revenue growth outside the U.S. The number of commercial patients on SPINRAZA increased by approximately 20% from last quarter and we now have close to 6,000 patients on SPINRAZA, including the expanded access program and clinical trials. In the U.S., we continued making progress with adults. In the third quarter more then 50% of new starts were adults, increasing the number of adult populated patients on SPINRAZA by more then 20% compared to last quarter. Outside the U.S., the pace of reimbursement for SPINRAZA across multiple geographies lead to meaningful revenue growth with significant revenue contribution not just from Europe, but also from Asia-Pac and Latin America. We have received regulatory approval in five more countries and we have made two more regulatory filings. We…

Michael Ehlers

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

Thank you, Michel and good morning, everyone. In the third quarter we made important progress across our differentiated neuroscience pipeline, including our industry leading Alzheimer's disease portfolio. So I'm delighted today to review advances we made across our core and emerging growth areas, as we prioritize our activities and build depth in our most promising programs in disease areas. Starting with Alzheimer's disease and dementia. This week we are presenting data at the Clinical Trials and Alzheimer's Disease meeting or CTAD on the safety and efficacy of aducanumab, our monoclonal antibody of the binds soluble and insoluble aggregated forms of beta amyloid, including oligomers, protofibrils and fibrils. These presentations will include a 36 month analysis of the aducanumab titration dosing regimen and a 48 month analysis of the fixed dose cohort both from the long-term extension of the Phase 1b PRIME study of patients with early Alzheimer's disease. The results are generally consistent with the previous interim analyses and there were no changes to the risk benefit profile of aducanumab. Live webcasts of our oral presentations, as well as an investor Q&A call will be available on the Investor section of our website. Also at CTAD, our collaborator Eisai will present a clinical and biomarker updates from the Phase 2 study of BAN2401. These results will be presented in an oral session at CTAD and a live webcast of the presentation will be available on Eisai’s website. Additionally, Eisai will present safety and efficacy data from the Phase 2 study of elenbecestat, a small molecule base inhibitor being evaluated in two Phase 3 studies in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. In parallel to advancing Phase 3 clinical development aducanumab, we are also planning to initiate EVOLVE, a Phase 2 study designed to assess…

Jeff Capello

Analyst · Geoffrey Porges with Leerink. Please go ahead

Thanks, Mike. Good morning, everyone. I'll now review our financial performance for the third quarter of 2013 starting with revenues. Total revenues for the third quarter were $3.4 billion, growing 12% year-over-year. Starting with our MS franchise revenues. Overall our MS business delivered revenues of $2.3 billion in the third quarter of 2018, including OCREVUS royalties for approximate $137 million. MS revenues in the third quarter of 2018 were down 3% versus the per year with OCREVUS royalties and were relatively stable including OCREVUS royalties. In the U.S., channel inventory levels were relatively stable for TECFIDERA, AVONEX and PLEGRIDY combined. Versus prior year foreign exchange rates and hedging had a minimal impact on ex U.S. MS product revenues for the third quarter. Global third quarter TECFIDERA revenues were $1.1 billion, a 2% increase versus the prior year. This included revenues of $842 million in the U.S., an increase of 1% versus the third quarter of 2017 and $248 million outside the U.S., an increase of 6% versus the third quarter of 2017. On a year-over-year basis, TECFIDERA revenues were relatively stable in the U.S. versus the decline we saw in the first and second quarters. In addition, we were very pleased with TECFIDERA’s performance outside the U.S., driven by year-over-year patient growth across each large European market, solid emerging market growth and particularly strong performance in Japan where TECFIDERA has now reached over 25% market share. Even though trends outside the U.S. were strong, it's important to note that Q3 x U.S. TECFIDERA revenues were negatively impacted by ongoing price decreases in certain European countries. TYSABRI world wide revenues were $470 million this quarter, relatively stable versus the third quarter 2017. This included $253 million in U.S. and $217 million outside the U.S. In the U.S. revenues declined 5% versus…

Michel Vounatsos

Analyst · Evercore. Please go ahead

Thank you, Jeff. We closed the third quarter with double-digit revenue and earnings growth versus a year ago, an exciting progress across our pipeline. And last week we launched a new biosimilar. Looking forward within the next 12 to 18 months, we expect further progress across our neuroscience pipeline, including Eisai's presentation of the BAN241 data this week at CTAD and assessing next steps. Data readouts across Alzheimer's, including the final Phase 3 data for aducanumab, as well as MS, PSP, ophthalmology and ALS and filing for regulatory approval in the U.S. for BIIB098 in MS. And using the updated NURTURE data as the most recent example, we continue to see compelling evidence across the neuroscience landscape that leads us to believe we are at the beginning of a period of transformative breakthroughs in the treatment of neurological diseases. We believe we are uniquely positioned to benefit from these potential breakthroughs and Biogen score is to be the long-term leader in neuroscience. To deliver [ph] on our aspiration we remain focused on executing well on strategic priorities to fortify our in MS and SMA and allocate capital to expand and progress our neuroscience pipeline, while opportunistically returning capital to shareholders. Finally, I want to reiterate our commitment to maximizing returns to our shareholders and bringing innovative therapies to patients over the long-term. These demands [ph] as 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 super returns from the investment we are making. Once again, I would like to thank our employees around the world, who are dedicated to making a positive impact on patient’s lives. And all of the physician [indiscernible] and participants in our clinical development programs [ph], our past and future achievements could not be realized without their passion and commitment. With that, we’ll open the call for questions.

Operator

Operator

[Operator Instructions] Your first question comes from the line of Umer Raffat with Evercore. Please go ahead.

Umer Raffat

Analyst · Evercore. Please go ahead

Hi. Good morning. Thank you for taking my questions. Michel, I think we've all asked Biogen's R&D leaders on this in the past and I'm curious to get your view on this, which is, do you think BAN2401s previously reported results at higher doses were entirely driven by a baseline imbalance on care status?. And based on everything we've seen to date, is Biogen willing to pay for Phase 2 and BAN or is there a way to opt out?

Michel Vounatsos

Analyst · Evercore. Please go ahead

Thanks for the question, Umer. We have seen the data obviously, but we have two days to wait for the 25th in Barcelona. So we have to be patient and Eisai’s presentation we give a slide on the next steps. Please understand. Thank you.

Operator

Operator

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

Geoff Meacham

Analyst · Geoff Meacham with Barclays. Please go ahead

Hey, guys. Good morning and thanks for the question. On aducanumab looking at the 3Q slides versus prior periods, this is the first time you guys have noticed that the Phase 3 data for ENGAGE and EMERGE is “final”. Am I reading too much into that? I am just thinking about the willingness to take an interim look? And related on the EVOLVE study, what was the driver for initiating the Phase 2, was it regulatory ongoing analysis or just - a Phase 3 or is it pre-planned? Thank you.

Al Sandrock

Analyst · Geoff Meacham with Barclays. Please go ahead

Hi Geoff, its Al Sandrock. Well, I wouldn't read too much into that statement about final analysis. We're not commenting on whether or not we're going to do an interim analysis and help you understand the main reason for that is that we want to maintain clinical trial integrity. On the drivers for EVOLVE, it really wasn't driven by a regulatory request. It was our desire to see whether or not MRI monitoring was necessary. So in this study you know, what we're looking - what we're doing is, all symptomatic ARIA is being addressed the way it is now in the current clinical trials. It's really how you deal with the asymptomatic ARIA, which is what the study is looking at and whether or not the MRI monitoring that's being done is actually necessary. And so that's the main purpose.

Operator

Operator

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

Geoffrey Porges

Analyst · Geoffrey Porges with Leerink. Please go ahead

Thank you very much for taking my quick question, Just a couple of data ones. Could you clarify the contribution of net price to your U.S. market and product performance? And then secondly, could you give us some commentary on SPINRAZA treatment persistence by Type 1, Type 2 and Type 3 patients so far? Thanks.

Jeff Capello

Analyst · Geoffrey Porges with Leerink. Please go ahead

Hi, Geoff. Its Jeff. So from a pricing perspective in U.S. and MS, we had a slight benefit from a pricing perspective in the U.S. that benefited our products within the quarter based on pricing increases earlier in the year.

Al Sandrock

Analyst · Geoffrey Porges with Leerink. Please go ahead

And Geof, just commenting on the question on SPINRAZA treatment persistence across SMA types. In our experience, essentially there's been a very durable and persistent treatment effect of SPINRAZA across all types.

Operator

Operator

Your next question comes from the line of Matthew Harrison with Morgan Stanley. Please go ahead.

Matthew Harrison

Analyst · Matthew Harrison with Morgan Stanley. Please go ahead

Great, good morning. Thanks for taking the question. I guess, I was hoping for a little bit more clarity on what was going on with the SMA gene therapy product and maybe specifically if you could also address that do you think the preclinical observations are centered specifically on this program or do they impact your broader gene therapy pipeline? Thanks.

Al Sandrock

Analyst · Matthew Harrison with Morgan Stanley. Please go ahead

Hi, Matthew. I'll take that question. I mean, we're not really going to comment on ongoing FDA interactions. I would say of course those interactions are program specific, but we won't really discuss details about those interactions at this point.

Operator

Operator

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

Ying Huang

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

Hi, good morning. Thanks for taking my question. To an extent you can comment - can you confirm whether you will interact with FDA about BAN2401 for Phase 3 strategy or even filing for that based on Phase 2b or not. If you cannot answer that, I would like to ask a question about SMA. We have seen data from both Roche and Norvartis on their oral programs, given the setback of you gene therapy program, does that change your strategy about future development in SMA, trying to maintain a leadership here? Thanks.

Al Sandrock

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

Hi. This is Al. I’ll take the first part. We're not commenting on regulatory interactions, that we’re basically in the middle of right now, so I can't answer your first question, sorry.

Michael Ehlers

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

And I'll take the question on the Roche oral and SMA commitment, I mean just to be completely clear we remain highly committed to SMA. We follow other programs and experimental therapeutics and development. We are aware of the data that Roche and PTC have presented around their oral compound. We know that the field is very interested in the long-term safety and tolerability of that compound as are we. I would say that our - the most recent NURTURE data that I mentioned really highlights the compelling efficacy profile of SPINRAZA and you know, when we look across just the clinical experience to date, I would remind that while we were very interested in - I think it's roughly 21 Type 1, 35 Type 2, Type 3 patients in the Roche PTC study, it had nearly 6000 patients for close to up to six years in some instances of patients on SPINRAZA. So we have the largest body of clinical evidence for any SMA therapy.

Michel Vounatsos

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

If I may, this is Michel. I just wanted to add that we are adding momentum in the U.S. in penetrating the idle h population. And this was unsure at the beginning of the year, uncertain at the beginning of the year and ex-U.S. we have staggering launches in different geographies and if in some, we may see some of the effect we are seeing in the U.S., following the first year of dosing. There are plenty of countries that are being here where we are launching. We just filed in China, for example, we are unlocking patient population also in Latin America. We are doing extremely well in Japan and continue to well in core Europe. So the momentum is good, but again, the biggest satisfaction is the implementation capability in the U.S. in the 65% of the market that has adult [ph] population.

Operator

Operator

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

Cory Kasimov

Analyst · Cory Kasimov with JPMorgan. Please go ahead

Hey. Good morning, guys. Thanks for taking my question. I was wondering if you can comment on the 2019 pricing outlook for your MS franchise based on your formulary negotiations? Thanks.

Michel Vounatsos

Analyst · Cory Kasimov with JPMorgan. Please go ahead

Unfortunately we will not be able to comment on price. We see the magnitude and the frequency of price being taken in the marketplace in the past, but we cannot comment on the future. Thanks for understanding.

Operator

Operator

And your next question comes from the line of Michael Yee with Jefferies. Please go ahead.

Michael Yee

Analyst · Michael Yee with Jefferies. Please go ahead

Great. Thanks for the question. Question on biosimilars. You made a comment that obviously you are launching the HUMIRA biosimilar, but that fourth quarter I guess, biosimilars would be stable. Can you just comment on A, your outlook on a HUMIRA biosimilar versus the type of business you're doing Enbrel business? And then more importantly, where do you think this $500 million business can go over the next few years, given you've obviously made some bullish comments on that? Thanks.

Michael Ehlers

Analyst · Michael Yee with Jefferies. Please go ahead

So Michael, we’re pretty excited about the launch, the team has already hit the ground. I think they're very well-prepared and we'll see some contribution, we believe in the in the fourth quarter. You know, a lot of those contracts, big contracts in Europe are tenders that take a little bit while to kind of ramp up. That's why you won't see as much of an impact in the fourth or quarter. There's also some pricing pressure across some of the other two lines that we’re - there on. So it kind of negates the benefit we'll get - expect to get from a morality perspective. But we think this business has the opportunity to potentially double over the next couple of years based on morality and we'd like as we said before based on a relationship with Bioepis to add more compounds. So we believe that this is a good growth opportunity for us and we're quite excited about the future.

Michel Vounatsos

Analyst · Michael Yee with Jefferies. Please go ahead

So this is not the first entity in there that is being launched in Europe, this is the third one. And I would say the purchase pattern and the journey is well set for those countries in terms of two big categories. The one that – from tenders and the one for which decision is left more the physician levels. So we anticipate that to be adalimumab biosimilar we’ll penetrate [ph] at least as strong as the previous one, even stronger. And I would like to remind you that we are the only company having the three anti-TNFs in the marketplace. So the team is already motivated, supply is ready and while we speak prescriptions are going up.

Operator

Operator

Your next question comes from the line of Phil Nadeau with Cowen and Company. Please go ahead.

Phil Nadeau

Analyst · Phil Nadeau with Cowen and Company. Please go ahead

Morning. Thanks for taking my question. I want to ask another one on SPINRAZA competition. It sounds like your expectations for growth for SPINRAZA, especially in the U.S. are largely from the adult population, it does seem like Roche and PTC with an oral compound could have a key differentiating feature for that population. So how do you see competition coming in – in the adult population and how could you differentiate SPINRAZA for those patients? Thanks.

Michael Ehlers

Analyst · Phil Nadeau with Cowen and Company. Please go ahead

So Phil, maybe I'll start another may have a comment here too. I mean, in essence we – we’re very confident in what we see with the clinical data on SPINRAZA. We're encouraged by the - the ongoing studies in teens and adults that we see in the access, including in complex spine patients, SPINRAZA. But we're very aware of the other competitive programs out there. It's early days and in lot of those. And like I mentioned we know the field is very interested in the long-term safety and tolerability of the orals. We know that there are questions around the dose selection that will ultimately be used there. And to date it's a relatively small number of patients, but we are certainly staying aware of it.

Michel Vounatsos

Analyst · Phil Nadeau with Cowen and Company. Please go ahead

So we were able somehow together with the physicians to deliver 30,000 dosing of SPINRAZA during the past month is because in real world there is an efficacy perception at the patient level. So its an efficacy play for those patients who are just the right [indiscernible] and the convenience comes after, this is what is being was backed by the customers. So with 3000 patients being dosed and more than 300 patients in clinical trial, we had a body of evidence that is still difficult to match for the time being.

Operator

Operator

Your next question comes from the line of Carter Gould with UBS. Please go ahead.

Carter Gould

Analyst · Carter Gould with UBS. Please go ahead

Morning, guys. Thanks for taking the question. I guess for Jeff or Michel, just on the BASR versus committing for BD [ph], obviously, you’ve been pretty active so far this year on the BD front. So maybe just kind of how you see that balance and I guess looking out the next sort of 12 to 18 months, how you see that may be evolving? Thank you.

Jeff Capello

Analyst · Carter Gould with UBS. Please go ahead

Yes. So thanks for the question. So you know, I think the nice position we're in is given our cash flows, we generate $1.7 billion of cash flow for the quarter again which is strong cash flow and given our net debt position. We have the luxury of being able to do both, both to invest in the business from a pipeline perspective and return capital to shareholders. So we've now done eight acquisitions and licensing type deals/acquisitions since Michel is been CEO, so we’re very encouraged by that and we expect to do more. A lot of that been done kind of in the - in the early to mid stage. We'd love to get something later stage done. But we also have ample cash capacity to return capital to shareholders. We bought back $10 billion of stock over the last couple of years and I would just remind investors that we have a new $3.5 billion share repurchase program that the board has recently authorized. So we have ample capacity to do both. Certainly we would be a preference to get more done in the pipeline and get more done that’s later stage. So certainly that would be kind of the focus or the preference, but we have the capacity to do both.

Michel Vounatsos

Analyst · Carter Gould with UBS. Please go ahead

So if you look at the momentum that Biogen is able to deliver, year-to-date, if I am not mistaken is 12% on the topline and with leverage P&L. This was not anticipated two years ago because of OCREVUS launch, because of limited potential of SPINRAZA, because of neglected biosimilars and the rest. And here we are. So we're not on a burning platform and the level of rigor and alignment to the strategy, to the scientific validity, to the IP and to financials criteria remained very rigorous within the organization and even more importantly, we have some very important readouts in the coming months. So in the meantime we deliver, we tightened the belt and we're evaluating opportunities, but in a very best manner.

Operator

Operator

Your next question comes from the line of Salim Syed with Mizuho. Please go ahead.

Salim Syed

Analyst · Salim Syed with Mizuho. Please go ahead

Yeah. Hi, guys. Thanks for taking the question. This one's for probably Mike or Al, just on the XLRS gene therapy program. Can you confirm that we're still getting topline data in the fourth quarter of this year? And what are you looking for in terms of deeming the trial a success? Thank you.

Al Sandrock

Analyst · Salim Syed with Mizuho. Please go ahead

Yes. So thanks for the question on this. So you know, right now on the XLRS program, we recall that this is a collaborative program with AGTC. The kind Phase1/2 trial is ongoing. This is an adult subsequent [ph] XLRS and at the moment we are anticipating that we could get a data readout projected in the first part of next year or so. But of course, these are always dependent on timing and enrolment of the right subjects. We're also very interested in no differences for example in the adult versus pediatric population this disease or some heterogeneity. As you may know in kind of the path of - pathology in XLRS because it has to do with exact location of the retina, specific visual endpoints you need and so forth. But to date the program is on track.

Operator

Operator

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

Robyn Karnauskas

Analyst · Robyn Karnauskas with Citi. Please go ahead

Hi, guys. Thanks for taking my question. So from your from your presentation it's – there is a lot on your pipeline, that it feels like you're focused on – and just trying to understand a little bit, as we see all these reads that are going to come out over the next 12 to 18 months, excluding Alzheimer's programs, which do you think have been the greatest ability to have a read to Phase 3. In other words, like - will give you the most confidence that there is a real proof of concepts or proof of potential success for those indications, as historically we know if something works for Biogen with your leverage the stock's ability to go up a lot. So help us understand which are those you think are the least risky and have the greatest read to the next stage of development?

Michael Ehlers

Analyst · Robyn Karnauskas with Citi. Please go ahead

Okay. So this is Michael. I'll try to take some of that. Thank you by the way for the question. I mean, as we show - I mentioned and so we do have a number of upcoming data readouts at different stages across the pipeline that have, I’d say different ramifications. A few things that we noted there is that we will start getting data on our BIIB67, SOD1 ALS program either towards the end of the year or early next year. This we think will be important primarily as a second leasing ASO program, in this case an adult indication with a different mechanism of action in the RNase H mediated knockdown of a pathological gene target. So we're very interested to see the biomarker and potential clinical efficacy data from that. That likewise has the potential to influence our thinking on other genetic targeted ASO programs like BIIB078, like I mentioned C9ORF72 positive ALS, as well as our tau ASO program which is currently in Phase 1 study in Alzheimer's disease. But I see there are more. We are - we have been very successful in advancing our BIIB092 program in progressive super nuclear policy. This is obviously a rare severe orphan disease. So I think this could give us an accelerator opportunity. And beyond that we're – we’ve initiated our Phase 3 study in BIIB093, so that will be ongoing. And although it's really first of its kind you know, we're very encouraged by the responsive side. And of course, you know, we announced that earlier this year that we completed enrolment in ENGAGE and EMERGE - aducanumab which is an 18 month dosing period study. That among others I think constitute an array of upcoming data readouts and have the potential to create significant excitement.

Operator

Operator

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

Ronny Gal

Analyst · Ronny Gal with Bernstein. Please go ahead

Good morning, everybody and thank you for hitting me in. Two questions for Mike on the pipeline. Mike, first the BIIB104 AMPA regulator. AMPA is been particularly difficult target to drug. Can you discuss a little bit how you convinced yourself you can avoid the toxicity that has been seen with this target before? And second about 093 [ph] glyburide program. Essentially, is this one of those programs that has the potential of reading out early? Is there interim analysis here? You kind of think about stroke or something you can accumulate there pretty quickly, how you're thinking about a potential of this program to actually readout head of time?

Michael Ehlers

Analyst · Ronny Gal with Bernstein. Please go ahead

Okay, thanks, Ronny for the questions and I’ll try to take these briefly. On BIIB104 what we were encouraged by there was - was really a quite differentiated and tight pharmacokinetic profile and safety profile that have been reserved both pre-clinically and clinically. It was really quite different from previous or earlier generation AMPA PAMs. So to date the clinical and preclinical data that have been seen have supported a favorable tolerability profile, as well as showing indications of efficacy in a few different clinical studies and of different designs in the domain of working memory and cognition. So we think there are differentiating features that have to do with some of the very specific pharmacology of this compound versus others previously in the class. So we think is differentiated. On BIIB093, we won't talk about an interim analysis on that, but I would say is that we have had a very strong response on site engagement, site activation and investigator interests because obviously there has been really no alternative for patients having a large hemispheric infarc.

Operator

Operator

Your next question comes from the line of Terence Finn with Goldman Sachs. Please go ahead.

Terence Finn

Analyst · Terence Finn with Goldman Sachs. Please go ahead

Hi. Thanks for taking the questions. Maybe just first on the financials, I was wondering if you can help us think about your tax rate heading into ’19, you guys - it looks like you’ve continue to bring that lower throughout the course of the year. And then any guidance on the operating margins for the biosimilars franchise that you can offer at this point? And then just one on the pipeline for 8700, you mentioned some new endpoints in that study. Can you just review what changed there? Thanks.

Jeff Capello

Analyst · Terence Finn with Goldman Sachs. Please go ahead

Thanks. So with regard to the tax rate, we're currently running at low 20% tax rate, as I mentioned in the script. We did mention when tax reform first got implemented that we expected the tax rate to come down again in 2019, as a result of some accounting factors that are more unique to kind of how our tax works around the world. We still expect that to be the case and we'll be able to provide you a more specific expectation on that when we release guidance in January for 2019. In terms of operating expenses, as I mentioned you know, we expect the fourth quarter to tick up a little bit as we continue to invest in the pipeline and drives some of the growth that we're seeing from a commercial perspective in SMA. We're still in the middle of kind of going through our planning process for next year. What I can share with you is based on the strength of our lean and simple cost savings initiative, we expect to take money out of kind of the G&A area and invest that back into the pipeline, grow our spend and our and our projects with regard to R&D. So we are very committed to that continuing to increase the innovation in neurology of the company.

Michael Ehlers

Analyst · Terence Finn with Goldman Sachs. Please go ahead

So I think it was a question on 8700, I am going to interpret that as BIIB098.

Michel Vounatsos

Analyst · Terence Finn with Goldman Sachs. Please go ahead

Yes.

Michael Ehlers

Analyst · Terence Finn with Goldman Sachs. Please go ahead

If that's not asking, but I’ll just say that on BIIB098 we have used data from the Part A of the study to inform Part B where we've expanded the patient - patient number in the head to head study against TECFIDERA, where again we anticipate that we'll be able to file on this data this year looking an approval potentially in the first half of next year or mid next year.

Operator

Operator

And your final question comes from the line of Chris Raymond with Piper Jaffray. Please go ahead.

Chris Raymond

Analyst · Piper Jaffray. Please go ahead

Thanks for squeezing me in. Yes, just another question on BIIB098. Just on the strategy here, I do think this launch could be kind of unique. So you filing under 505 B2 pathway, but you will have a head to head versus TECFIDERA on tolerability, which you talked about. Some of our work indicates that you know that's kind of you know one of the bigger reasons for discontinuation of TECFIDERA tolerability issue. So if BIIB098 sort of repeat the clinical data we've seen so far that should address you know, essentially a big issue of TECFIDERA. So how do you approach the marketing and positioning of this drug and how should we think about these two drugs coexisting over time? And then also just on that point, I think in your slide you guys talk about a 2020 approval, but I think I just heard you guys mentioned that or maybe second half 2019 approval, can you sort of talk about that timing? Thanks.

Michel Vounatsos

Analyst · Piper Jaffray. Please go ahead

Thanks for the great question. And the first I would like to say that we are pleased with the momentum behind TEC . I think this is important. So TEC will remain always front end center. We are doing well. We grow the volume even if we price, we face some crushing pressure in part of the world like in Europe and we have increasing competition. So BIIB098 will offer the opportunity eventually to have a an upgrade in terms of safety profile and GI safety and this will be eventually the low hanging fruit that we aim to move further. And the team is working towards the longer term lifecycle management opportunities that these product offers beyond the fumarate. So is what we're working on. But we are very excited about this opportunity and to expand our leading share of orals, but beyond the fumarate market. So looking forward to this filing and potentially launch towards the end of ‘19 or early 2020.

Michel Vounatsos

Analyst · Piper Jaffray. Please go ahead

So at this stage, I would like to close the call by saying a very exciting times that Biogen we are looking forward to the data readouts and I thank you all for attending our call today. Have a good day.

Matt Calistri

Analyst · Piper Jaffray. Please go ahead

Thank you for joining today's call. Before we conclude, I would like to remind everyone that we plan to host three webcast from CTAD later this week, on Thursday October 25th at 730 a.m. Eastern Time. We will webcast the keynote presentation from Samantha Budd Haeberlein, Vice President, Alzheimer's disease, dementia and movement disorders later stage clinical development, titled what we learned from Aducanumab. Later that day at 4:15 p.m. Eastern Time we will host an Investor Q&A webcast to discuss the Alzheimer's portfolio with Dr. Al Sandrock, our Chief Medical Officer and Samantha Budd Haeberlein and on Friday October 26 at 9:15 a.m. Eastern Time we will webcast the oral presentation titled aducanumab titration dosing regiment, 36 month analysis from PRIME, a Phase 1b study in patients with early Alzheimer's disease. The links to those webcast can be found on the Investor section of Biogen’s website at www.biogen.com. Thank you and we look forward to speaking with you in the future.

Operator

Operator

Thank you to everyone for attending today. This will conclude today's call and you may now disconnect.