Earnings Labs

Biogen Inc. (BIIB)

Q2 2019 Earnings Call· Tue, Jul 23, 2019

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Transcript

Operator

Operator

Good morning. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2019 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. [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 Biogen CEO, Michel Vounatsos. You may begin your conference.

Michel Vounatsos

Analyst · JPMorgan

Thank you. Good morning, everyone and thank you for joining us. I would like to start by thanking Matt Calistri for nearly four years he spent leading our Investor Relations program. We wish him the very best in this next endeavor. I would like to welcome Joe Mara, our new Vice President and Head of Investor Relations, who is a talented and energized finance and business leader with over 12 years of experience at Biogen across a number of functions. I am confident that Joe will prove to be a valuable resource for the investment community and I look forward to all of you getting to know Joe. Joe the floor is yours. Welcome.

Joe Mara

Analyst

Thank you, Michelle. And welcome everyone to Biogen's second quarter 2019 earnings conference call. I look forward to getting to know all of you over the coming months. Before I 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 one and two and 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 am joined by our Chief Executive Officer, Michel Vounatsos; Dr. Michael Ehlers, EVP of the 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. Now, I will turn the call back over to Michel.

Michel Vounatsos

Analyst · JPMorgan

Thank you, Joe. Now let me begin with some financial highlights. Compared to the same period a year ago, Biogen delivered solid topline and bottom line growth. Second quarter revenues grew 8% to $3.6 billion. Second quarter GAAP earnings per share grew 88% to $7.85 and non-GAAP EPS grew 58% to $9.15. Based on our strong performance year-to-date and our dated outlook for the second half of the year, we are raising our full year financial guidance, which Jeff will discuss in more details. Now let me review the highlights from the second quarter. First, revenues from our MS core business, including OCREVUS royalties increased 3% versus the prior year to $2.4 billion. Excluding OCREVUS, the total number of patients on our MS products globally grew in the low single digits versus the prior year. Critically, we are focused on addressing the IP challenge with TECFIDERA, while also preparing for the expected launch of VUMERITY towards the end of the year. Second, SPINRAZA global revenues grew 15% to $488 million driven by year-over-year revenue growth both in the US and outside the US. The number of commercial patients on SPINRAZA increased by approximately 12% from last quarter and we now have approximately 8400 patients on SPINRAZA, including the Expanded Access Program and clinical trial. Within the US, the number of SPINRAZA patients increased by approximately 4% versus Q1 which we believe demonstrates the potential for continued patient growth in the more mature markets. We were very proud to announce new data for the neutral study of SPINRAZA. We have continued to generate long-term data across broad patient populations which underscore the compelling safety and efficacy profile of SPINRAZA. Many are focused on the potential of new competition for SPINRAZA. While we welcome new options for patients, we believe it is…

Michael Ehlers

Analyst · JPMorgan

Thank you, Michel. And good morning, everyone. We are very pleased with the progress in our industry-leading neuroscience pipeline and with our expanding efforts in immunology. Illustrating the momentum in our portfolio, we look forward to 10 mid to late-stage readouts over the next 18 months. As Michel mentioned, our top priorities are to continue strengthening our franchise in MS and neuromuscular disorders. Beyond these priorities we are refining the emphasis within our core and emerging areas. To that end based on the opportunities we see following our acquisition of Nightstar Therapeutics, we now view ophthalmology as a core growth area. Moreover, recognizing the potential of our existing assets and long-standing expertise in immunology we can now consider this to be an emerging growth area. Diving in, let me begin with advances we made in the second quarter to secure long-term scientific leadership in our MS and neuromuscular franchises. At the annual meetings at the American Academy of Neurology and the consortium of multiple sclerosis centers, we presented new interim data from EVOLVE MS-1, an ongoing single-arm open-label 2-year Phase III study, evaluating the safety and efficacy of diroximel fumarate to be marketed as VUMERITY if approved by the FDA in patients with relapsing-remitting MS. Interim results in 696 MS patients showed that treatment with diroximel fumarate was associated with a 79% reduction in the annualized relapse rate over one year when compared to baseline, with an 83% reduction in newly diagnosed patients. The mean number of gadolinium-enhancing lesions in patients treated with diroximel fumarate was reduced by 77% compared to baseline in the total population and by 96% in newly diagnosed patients. Over one year the rate of gastrointestinal adverse events leading to discontinuation was 0.7%. GI tolerability of diroximel fumarate versus TECFIDERA is been evaluated in the ongoing…

Jeffrey Capello

Analyst · JPMorgan

Thanks, Mike. Good morning everyone. I'll now review our financial performance for the second quarter 2019 starting with revenues. As Michel mentioned earlier, we had a very strong Q2, 2019 from a revenue perspective. Total revenues for the second quarter grew 8% year-over-year to approximately $3.6 billion. Overall our MS business delivered revenues of approximately $2.4 billion in the second quarter 2019, including OCREVUS royalties of approximately $183 million, growing 3% versus the prior year. Global MS revenues in Q2 2019 were stable versus the prior year without OCREVUS royalties. US MS revenues in Q2, 2019 were impacted by a decrease in channel inventory of approximately $25 million compared to a decrease of approximately $50 million in Q2, 2018 and a decrease of approximately $175 million in Q1, 2019. In addition this quarter we benefited from lower than anticipated discounts and allowances, which is not expected to continue for the rest of the year. Global second quarter TECFIDERA revenues increased 6% versus the prior year driven by revenue growth both in the U.S. and outside the US. U.S. TECFIDERA revenues were impacted by decrease in channel inventory for approximately $10 million in the second quarter 2019 compared to a decrease of approximately $40 million in Q2, 2019 and a decrease of approximately $110 million in Q1, 2019. We were pleased to see a continued increase in the share of new prescriptions for TECFIDERA in US and for the second consecutive quarter our share of new prescriptions exceeded our share of total prescriptions. Additionally, our share of new prescriptions in the US for TECFIDERA is now its highest point since the launch of OCREVUS. Outside the US, TECFIDERA performed very well in Q2, 2019 with continued volume increases across all large European markets and Japan versus the prior year somewhat offset…

Michel Vounatsos

Analyst · JPMorgan

Thank you, Jeff. Biogen demonstrated strong commercial execution this quarter and we continue to apply our world class capabilities expertise to progress our pipeline, all while maintaining a diligent focus on continuous improvement and strategic capital allocation. Between now and the end of 2020, we expect continued progress as we aim to build inventory franchise portfolio, including 10 mid to late stage data readouts in MS, PSP, lupus, epilepsy, Parkinson’s disease, cognitive impairment associated with schizophrenia, stroke and ophthalmology, and potential regulatory approval in the US for VUMERITY in MS. Finally, I want to reiterate our commitment to maximizing returns to our shareholders and bring innovative participation 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 returns from the investment we make. As we are closing a solid quarter, I would like to step back and comment on what we stand for as a company and how we conduct our business. We believe doing the right things for patients, employees, the environment and the communities we serve will help build sustainable value for all our stakeholders including our investors. After 41 years, we are extremely proud of our track record and commitment to sustainability. Finally, 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, caregivers and participants in our clinical development programs, our past and future achievements could not be realized beyond the passion and commitment. With that, we will open the call for questions.

Operator

Operator

[Operator Instructions] Our first question comes from the line of Cory Kasimov with JPMorgan.

Cory Kasimov

Analyst · JPMorgan

Hey. Good morning, guys. And thank you for taking my question. So want to ask about SPINRAZA. And it sounds like there hasn't been an impact thus far from Zolgensma at least to-date. But I am curious if you're seeing any signs of potential warehousing of the minority portion of the SMA patients that are currently eligible for gene therapy? And how you're thinking about the growth outlook for the product when considering a nice year-over-year jump in sales, but another quarter-over-quarter decline before competition potentially kicks in? Thanks.

Jeffrey Capello

Analyst · JPMorgan

So Cory, this is Jeff. So this point we don't see - we haven't seen any indication that there maybe any warehousing, I mean, it's difficult to tell. But there is no impact at this point in time. I mean, as we mentioned patients were up pretty well year-over-year and they were up sequentially. And if you look at kind of the larger segment of that patient pool which is the adult segment, it's 60% of the market, we’ve only penetrated 20% of that, and Zolgensma was not indicated for that. So we think there is ample opportunity to grow within the US and continue to kind of post impressive patient numbers. Outside the US, you know, the opportunity frankly is larger. And if you look at the chart that we put out last quarter, we originally thought that the epidemiology within SMA was 20,000. We now think it’s 45,000. So there is more patients outside the US within the US. We can continue to open up new countries. And our experience in US and in the large European market would indicate that we can continue to kind of penetrate the mature markets and open up new markets. So we think, it's a good growth opportunity in front of us.

Michel Vounatsos

Analyst · JPMorgan

Mike?

Michael Ehlers

Analyst · JPMorgan

Yeah, Cory, I’ll add to that. Well, I mean, clinically one thing that's - that you need to consider and this is for what Zolgensma indicated for is the under age two - usually the more severe SMA patients for which time is really critical. We know that the time of treatment even before symptoms but certainly as a function of symptoms stage is really essential. So that would tend clinically to be a very different from a typical kind of scenario where you might be waiting for a different new treatment.

Michel Vounatsos

Analyst · JPMorgan

So let me share the underlying uptake of patients behind this very successful launch is the most, I will say, positive news in mature markets and in emerging geographies where we are gaining access. So we remain confident. Obviously there are more clinical trials in that space too and it’s still the early days for this new therapeutic alternatives. And we welcome alternative for patients based on the severity of the disease.

Operator

Operator

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

Terence Flynn

Analyst · Terence Flynn with Goldman Sachs

Hi. Thanks for taking the question. Maybe a two part. Just wondering Michel or Jeff, if there any original steps you’re considering to bolster your balance sheet here beyond the sale of Hillerød facility? And then you are fairly active on the repo front this quarter. Just - should we expect that pace to continue through the second half of the year? And should we read into it as a sign of your confidence in your TECFIDERA IP? Thanks a lot.

Michael Ehlers

Analyst · Terence Flynn with Goldman Sachs

So, one of the many hallmarks of Biogen is a company with very strong cash flows. We generated $3.4 billion of operating cash flow within the first six months and we've now had the expiration of the TECFIDERA Fumapharm payments. So at this point in time there is really no intent to kind of - if you mean by change the balance sheet, lever up the balance sheet is certainly not the intent. The company generates a lot of cash. With regard to uses of cash, I think we've been very consistent that our capital allocation strategy is centered around optimizing of the capital allocation to maximize shareholder value and we'll continue to do that and the good thing is we've got ample capacity to do that, either vis-à-vis share repurchase or continuing to add assets to the clinical pipeline, business development, or M&A. So I would look for us to be active across the board, because we’ll have the capacity, it's very strong company from that perspective.

Operator

Operator

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

Umer Raffat

Analyst · Umer Raffat with Evercore

Good morning. Thanks so much for taking my question. I wanted to focus on TECFIDERA for a second. And it seems that a few ANDA filers have withdrawn their ANDAs and the case has been dismissed under a joint stipulation. So my question is, has there been a formal settlement, because we haven't seen a press release or did those ANDAs just not meet bioequivalence?

Jeffrey Capello

Analyst · Umer Raffat with Evercore

So Umer, this is Jeff. We're not going to comment on the specifics of our IP situation, only to say that, as Michelle has said, a lot of interest in kind of getting it resolved.

Operator

Operator

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

Geoffrey Porges

Analyst · Geoffrey Porges from SVB Leerink

Thank you very much for taking the question. And congratulations on the good numbers in the quarter. I suppose, I have to ask follow-up on aducanumab. Previously, you disclosed that you are continuing to monitor the patients in the study and to see whether there was any evidence of clinical effect from the - in the pivotal studies with prolonged exposure. Could you share with us what you have found with that extended follow-up? And secondly, in that context, how much are you continuing to invest in the amyloid hypothesis and particularly in 2401 and Elenbecestat, could you kind of reconcile those two for us? Thanks.

Michel Vounatsos

Analyst · Geoffrey Porges from SVB Leerink

Geoff, thank you for asking this important question. Obviously, since we did not present at AIC it is clear to everybody that we are not ready. We are not finished with our analysis of the data, first available at the cutoff date of the futility analysis, but also the data that is coming after the cutoff date of the futility. So Biogen said and will continue to follow the science and these analyses have critical importance, as you can imagine, for the patients, for the community, for public health and also for all the stakeholders. And at the same time, Biogen is trying to new frontiers, which is difficult to define. So we will present the results of ENGAGE and EMERGE studies at the future medical meetings and I hope you appreciate that we cannot say much more at this stage.

Operator

Operator

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

Michael Yee

Analyst · Michael Yee with Jefferies

Hey, thanks. Good morning. Appreciate the question. I had a question for Al Sandrock if he's there, or Mike, but that was regarding the comments around BIIB092 the tau PSP study. I know you completed enrollment, I guess, late fall last year, so the data is coming like you alluded to. Maybe just talk to how we should put into context the Phase 2b? How much confidence you would have on the end point, but perhaps more importantly, if there are pre-specified endpoints you're looking at sub-groups? What's important to you define supporting the tau hypotheses for tauopathies or more importantly Alzheimer's? Thanks so much.

Al Sandrock

Analyst · Michael Yee with Jefferies

Yeah. Michael, this is Al. So the - we've been saying that the results will be available at the – later this year toward the end of this year. As you know, in the earlier phase studies we showed about 90% decrease in CSF-free tau. And so we definitely have target engagement, because the antibody was given intravenously and we looked in the CSF at tau. So we have target engagement in CNS. What we're hoping to see is an effect on the rating scale for PSP, which is not that different from the Parkinson's rating scale. As you know, there are - it has many of the - shares many of the features of Parkinson's disease, but there are some additional features that relate to PSP that will also be measured. And yeah, the big question right now is we have target engagement. We have lowered CSF tau. We're hoping to catch the tau as it spreads. The abnormally - the misfolded tau that spreads from cell-to-cell, there is a lot of great data that - there's prime like propagation in the CNS and PSP and in other tauopathies and we’ll see whether or not we catch it as it tries to spread and have a clinical effect.

Operator

Operator

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

Ronny Gal

Analyst · Ronny Gal with Bernstein

Good morning. And thank you for taking my question. Just couple of quick things on pipeline. On the PSP trial just following on Cory, how many of those patients had tau in their brain imaging? I know that wasn't available ahead of the trial, but I suspect you did it during the trial. And second Mike I noticed your investment in Skyhawk couple of weeks ago. Care to share with your roughly how long before you'll have an oral SME product in the clinic?

Michael Ehlers

Analyst · Ronny Gal with Bernstein

Okay. Yes, thanks for the question. I'll take both of those. First of all, just one point of clarification with tauopathy and PSP. The current PET imaging tracers for tau don't recognize the form of tau that accumulates in PSP, recognizes the form of tau that accumulates in Alzheimer's disease. This has to do with three hour versus four hour tau. So just to clarify that. None of them would have been imaged because there hasn't been an ability to image tau in the brain before that. On Skyhawk, yeah, that collaboration is proceeding very nicely. We’re working on several targets with them. We are zeroing in on potential new clinical candidates. We don't have a timeline just yet, but I would say that we're very, very happy with the progress on many targets in this way and we hope to get some to the clinic over the next couple of years let's say.

Operator

Operator

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

Phil Nadeau

Analyst · Phil Nadeau with Cowen and Company

Good morning. Thanks for taking my question. Just one question on the EVOLVE MS2 trial, you mentioned that data is going to be next few weeks. Could you do remind us to design of the study? And in particular aside from GI tolerability, what other data is going to be disclosed in the top-line release? And how you would frame risk-benefit just like you come of the space, so what would be a meaningful GI tolerability improvement in your mind?

Al Sandrock

Analyst · Phil Nadeau with Cowen and Company

Hi, Phil. This is Al Sandrock. So, it's basically a head-to-head study against TECFIDERA. The primary outcome measure is a patient-reported outcome on GI tolerability and we’re looking at essentially all aspects of GI tolerability, whether it's upper or lower, the severity, the duration and hopefully what we'll get at the end of it is an incidents, the idea of the difference in the incidence of GI tolerability events between comparison with TECFIDERA, as well as severity. And talking to our - the prescribers, the MS prescribers, incidence is probably the most important thing. Although, ultimately, you want to try to improve compliance, so we'll also be looking at things like discontinuation rate and which as Mike said in the EVOLVE 1 study, we had a very low discontinuation rate. So, we’re hopeful that we'll see a nice comparison to TECFIDERA in this EVOLVE 2 study.

Operator

Operator

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

Matthew Harrison

Analyst · Matthew Harrison with Morgan Stanley

Hey, good morning. Thanks for taking the question. I just want to follow-up on something Phil said. Can you just talk if you are able to achieve the profile that you've talked about with VUMERITY in terms of, let's say, lowering your incidence? I mean, how does that impact how do you think about the drug commercially. Would you expect to be able to try and switch TECFIDERA patients who are already stable, and because I know mostly GI effects come early in drug or how should we think about VUMERITY commercially if you are able to achieve that profile? Thanks.

Michel Vounatsos

Analyst · Matthew Harrison with Morgan Stanley

So thanks for the good question. Obviously, we need to consider the outset that the patients on TEC after the four, five, first weeks are stabilized that they are doing fine. So the strategy is not to switch, the strategy is to expand.

Al Sandrock

Analyst · Matthew Harrison with Morgan Stanley

Yeah, I mean most physicians that I talked to would not want to switch somebody who is done well, who stabilized the initial phases of taking TECFIDERA and or doing well in terms of tolerability. Of course, if there is breakthrough disease you would consider switching probably to a different mechanism of action.

Operator

Operator

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

Salim Syed

Analyst · Salim Syed with Mizuho

Hey, guys. Thanks for taking the question. Mike or Al, I had a question for you actually. You guys have mentioned in the past, I believe that you are looking at new MS targets. And I was curious what your thoughts were on EBV as a target? Thank you.

Michael Ehlers

Analyst · Salim Syed with Mizuho

Yeah. So, this is Mike. Look I'll say this has been a long-standing interesting hypothesis. We've really rejuvenated our effort on early targets in MS and novel target including something that might be virally based and other sales based. So early days in a lot of that. But we've created a new highly dedicated group, focused on early stage MS research in novel mechanisms. And so where we see an opportunity, independent of modality we will advance that.

Al Sandrock

Analyst · Salim Syed with Mizuho

The EBV is a very interesting virus, so if you look at epidemiological studies and MS, particularly out of Harvard School of Public Health. There is a strong implication that EBV infection precedes the onset of MS. It's very tantalizing that the B-cell follicles that are in CNS in the sub-meningeal space generally they are EBV positive. EBV effects B-cell function and B-cells are, obviously, important in MS as seen by all the drugs that are directed against B-cells, ocrelizumab and BTK inhibitors have seem to have efficacy. So, I think in some ways EBV is very interesting as a causal virus. However, in terms of treatment, once the virus activates the immune system toward an autoimmune state, I don't know whether getting rid of the virus will help. These B-cell follicles molecules in the CNS, perhaps getting rid of the EBV positive B-cells there maybe helpful. But treating the virus itself, you'd have to design a study very, very early, perhaps even before MS even starts.

Operator

Operator

Your next question comes from the line of Brian Abrahams with RBC Capital Markets.

Brian Abrahams

Analyst · Brian Abrahams with RBC Capital Markets

Hi, there. Thanks for taking my question. Appreciate the strategic updates, and congrats to Joe on his new role. You talked about immunology as more formalized area of focus. I was wondering if you can speak a little bit broadly about how you plan to approach the space, maybe which of your assets you expect to prioritize? And then potential BD and future commercial strategy that you're thinking about within immunology? Thanks.

Michael Ehlers

Analyst · Brian Abrahams with RBC Capital Markets

Sure, Brian. This is Mike. I'll start out with that. So we are very happy about this where we're going to start with focus is where we've got existing assets and or expertise. By and large right now that’s really going to start with our lupus program it include BIIB059, the BDCA2 antibody and dapirolizumab pegol, this anti-CD40 ligand Fab. And from that we will look at things that touch on that either within that indication space or perhaps in and around those mechanisms to expand. It will start with those places where we’ve got existing assets and or capability. We think it fits very nicely with a lot of the ongoing programs and things that we're otherwise doing. It also - I’d say on the business development front does give us an ability to look somewhat more broadly at external opportunities we might be able to use for either early or late supplementation of the pipeline.

Operator

Operator

Your next question comes from the line of Paul Matteis with Stifel.

Paul Matteis

Analyst · Paul Matteis with Stifel

Great. Thanks so much to taking the question. I wanted to ask a question on business development. What is Biogen’s thinking on the ongoing delays with the Roche Spark deal and what that might mean for your ability to do M&A in areas where you already have a strong presence? For example, you have a pretty broad pipeline and assets either in your pipeline or marketed in a lot of areas of neurology. Does the delay that's going on which seems to be about therapeutic overlap make you at all reluctant to be more aggressive in M&A in areas where you already have a presence? How did this complicate things, if at all? Thanks.

Michel Vounatsos

Analyst · Paul Matteis with Stifel

So it's always difficult to kind of I think what you're getting at is kind of antitrust. I think we will take a careful approach as we look at business development. But we don't see that deterrent, to be active from BD or M&A perspective, we will certainly be careful as kind of look at targets.

Operator

Operator

Your next question comes from the line of Evan Seigerman with Crédit Suisse.

Evan Seigerman

Analyst

Hi, guys. Thank you for taking the question and congrats on the progress. One for Al and Michael, so with the recent failure of base inhibitor reported by Amgen, Novartis why does Biogen continue to pursue development of Elenbecestat? And generally given the failure of a beta antibodies, what gives you confidence that targeting tau is the right approach for AD?

Michael Ehlers

Analyst · JPMorgan

So Evan, why don't I take the beginning of this? Of course you know, we're highly aware of all the announcements in and around base inhibitors and resent Novartis and Amgen announcement of the termination, they’re discontinuing their base inhibitors. So we're highly aware of this. I would say patient safety is paramount in our clinical trials, including the Mission AD1 and Mission AD2 trials for the base inhibitor that is being conducted in collaboration with our collaboration partner Eisai. Those studies have independent data in safety monitoring board that reviews the data regularly from those Phase III studies. And to-date the DSMB has recommended the studies proceed. They have an ability to look at that data when they want and they are certainly aware of the likewise the safety signals and discontinuation of other programs and they will be assessing as it goes along. As BAN2401, I'll refer back to what Michel commented on earlier, which is that we are in the midst of very thorough analysis of all the ENGAGE and EMERGE data from aducanumab which is an extensive data set and we would like to have a full understanding of that data before we make a specific forward development decisions on BAN2401.

Michel Vounatsos

Analyst · JPMorgan

I think we have time for about two more questions.

Operator

Operator

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

Carter Gould

Analyst · Carter Gould with UBS

Great. Thanks, guys. I guess for Michel or Michael, as far as your comments earlier around rebalancing the risk reward of the pipeline it sounded like that was really kind of externally focused, but I wanted to ask if there is any sort of thoughts underway to also revisit maybe our existing programs and any change there in sort of the hurdle for moving programs forward? Any color there would be appreciated? Thank you.

Al Sandrock

Analyst · Carter Gould with UBS

Yeah. Carter, good question. So I mean, the few things we would say to maybe flush that out a little bit. I mean, we've had an ongoing effort over some time to really look at the risk reward profile and that means to be able to balance risk in different categories and include things like seeking later stage assets where we can, taking advantage of unique capabilities where we see them leveraging our debt in certain areas like MS and neuromuscular, where we've got very strong franchises, and likewise going after the types of disease where we’ve got high confidence, things where there you've got genetically defined targets and genetically defined patient populations. And you can see examples of that in our pipeline that have been very intentional. These include things like VUMERITY, as a very good example of rebalancing risk, supporting our MS franchise. I think, you see that within our Nightstar acquisition and the mid to late stage clinical programs in gene therapy there, Choroideremia and X-linked retinitis pigmentosa. And hopefully that came across in my emphasis on our confidence in our ASO platform and ASO programs that we've been advancing collaboration with Ionis. In addition to that, I think, and Michel spoke to this, we look to our important clinical readouts, our 10 upcoming clinical readouts in the next 18 months as trigger points, to help define and refine the areas that we really want to concentrate resource and activity on in the future.

Michel Vounatsos

Analyst · Carter Gould with UBS

If I may just add to the good comments made by Mike, it's also the opportunity to widen the strategic plans and important readouts in the coming months in BIIB059 in lupus. So stay tuned.

Operator

Operator

Our final question will come from the line of Mohit Bansal with Citigroup.

Mohit Bansal

Analyst · Citigroup

Great. Good morning and thanks for taking my question and a very warm welcome to Joe from our side as well. So quickly on guidance, it appears to be indicating a slight decline or maybe flat revenues in the second half versus the first half. You mentioned inventory. But could you please provide little bit more granularity on the process or thought process for remainder of the year. Is RITUXAN biosimilar which is the bigger factor here? Thank you.

Michael Ehlers

Analyst · Citigroup

So we’re not – we have a policy of kind of giving guidance twice a year and not doing it by the product level, but what I can do is kind of maybe point you to some areas within the historical numbers. Certainly, in the first quarter, Bioverativ inventory sale certainly helped the first quarter inventory growth. You have to look at that. That was a one-time type element. We also, in the second quarter - the MS business was quite strong as a result of the less of an inventory dry down and some gross-to-net favorability, which we don't expect to continue. And then, two other factors that I would highlight is, SPINRAZA will face some more difficult comparisons in the second half of this year compared to the second - first half of this year. The numbers get bigger. And then finally, the RITUXAN and GAZYVA we've said all along that we expect competition to come in the fourth quarter. So if you look at all those factors, it would indicate there would be little more strength in the first half versus the second half.

Mohit Bansal

Analyst · Citigroup

Got you. Very helpful. Thank you.

Michael Ehlers

Analyst · Citigroup

Yeah.

Michel Vounatsos

Analyst · Citigroup

So thank you all for attending our call today. Another very strong quarter for our company, very exciting times at Biogen nowadays. Thank you. Talk to you soon.

Operator

Operator

Ladies and gentlemen, this will conclude today's call. Thank you all for joining. And you may now disconnect.