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 2020 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. Joe Mara, Vice President, Investor Relations. You may begin your conference.

Good morning, and welcome to Biogen's second quarter 2020 earnings 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, and Table 3 includes a reconciliation of our GAAP to non-GAAP financial results and our GAAP to non-GAAP financial guidance. 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. Al Sandrock, EVP, Research and Development; and our CFO, Jeff Capello. Now, I will turn the call over to Michel.

Good morning everyone. And thank you for joining us. With a focus on strong execution, we have continued to serve patients, advance our strategic priorities and delivered another strong financial quarter. Let me begin with some important developments. First, we have completed our submission for US approval of aducanumab, an unprecedented opportunity for patients and for Biogen to potentially bring to market the first therapy to reduce the devastating clinical decline and meaningfully change the cause of Alzheimer’s disease. I am incredibly proud of the Biogen’s team for their dedication and tireless work leading to the completion of our regulatory submission on July 7. This submission followed ongoing collaboration with the FDA and includes data from a comprehensive clinical development program, including EMERGE, the first positive Phase III study ever in this space. Together with supporting data from the Phase III ENGAGE study and positive results from the Phase Ib PRIME study. Our data show that aducanumab may help to both reduce the decline of cognitive function and help patients’ ability to perform certain activities of daily living, which for some patients may result in independence for a longer period of time. In terms of next steps, we anticipate receiving a response from the FDA within 60 days from the submission date, notifying us if the submission has been accepted, and if accepted whether we have been granted priority review, we plan to communicate both of these decisions via a press release. We have progressed in our US launch readiness, including increasing our medical engagement with experts and thought leaders to better assess how aducanumab could potentially impact clinical practice. We have started to make progress engaging with payers and defining aducanumab’s value proposition, and we have now established a cross-functional team dedicated to site readiness, which is currently operational.…

Thank you, Michel. And good morning everyone. I would like to start by thanking the Biogen team for their hard work as they continue to advance our R&D programs during these challenging times. Although some uncertainty remains on the impact that COVID-19 is having on our studies, I’m pleased that the majority of our clinical trials are currently on track or only slightly delayed with seven mid-to-late stage readouts expected by the end of next year. Let me now turn to the advances we made across our pipeline in the second quarter. Starting with Alzheimer’s disease. As Michel mentioned, we have completed the BLA submission for aducanumab to the FDA. This submission is based upon EMERGE, the first positive Phase III study for a therapy to reduce clinical decline in Alzheimer’s disease; supporting data from ENGAGE, although this study did not meet its primary endpoint; and positive results from the Phase Ib PRIME study. We participated in a pre-BLA meeting with the FDA. During which, the agency reiterated that submitting a BLA based on data from EMERGE, ENGAGE and PRIME was reasonable. We look forward to working with the FDA during their review and continuing our engagement with other regulators around the world. I want to congratulate the team for achieving this important milestone in the midst of the COVID-19 crisis. We also continue to develop a broader Alzheimer’s disease portfolio and believe we are well positioned for sustained leadership in this disease area. Part of this strategy includes expanding into even earlier patient populations with a goal of delaying or perhaps even preventing the clinical onset of the disease. To that end, our collaboration partner Eisai, in conjunction with the Alzheimer’s Clinical Trials Consortium announced initiation of the AHEAD 345 clinical study to evaluate BAN2401 in individuals with preclinical…

Thanks, Al. Good morning, everyone. We are pleased that Biogen had another strong quarter despite the COVID-19 challenges as we continued to execute well. We remain in a very strong financial position with significant cash and financial capacity to continue to grow the business over the long term. I will now review our financial performance in the quarter and provide an update to our full-year guidance. Total revenues for the second quarter grew 2% year-over-year to $3.7 billion. As a reminder, we believe that the Q1 2020 revenues included a benefit of approximately $100 million attributed to accelerated sales due to the COVID-19 pandemic, of which, we believe $75 million approximately was utilized in the second quarter of this year. Overall, we executed well in our MS business, delivering revenues of $2.3 billion in the second quarter, including OCREVUS royalties of $208 million, declining 2% versus the prior year. Global MS revenues in the second quarter decreased 4% versus the prior year without OCREVUS royalties. Importantly, in the current COVID-19 environment, we believe our MS products are well positioned versus the competition based on treatment guidelines from the MS International Federation. US MS revenues, excluding OCREVUS, were approximately flat versus the prior year. We were very encouraged to see growth in share of new prescriptions TYSABRI and interferon within the quarter despite the recent increase in competition. Outside the US, our MS revenues were $615 million, a decline of 11% versus the prior year, due in part to a negative effect of foreign exchange rates of approximately $35 million. In addition, we believe that the first quarter 2020 MS revenues outside the US included a benefit of approximately $59 million attributed to accelerated sales due to the COVID-19 pandemic, of which, we believe approximately $37 million was utilized in the…

Thank you so much, Jeff. Biogen continued to demonstrate strong execution this quarter. We again delivered solid financial results, made strong progress advancing our strategy of building a multi-franchise portfolio and importantly one step closer to a potential approval for aducanumab as the first therapy to reduce clinical decline in Alzheimer’s disease. I want to reiterate our commitment to maximizing returns for our shareholders and bringing innovative therapies to patients now and over the long term. This requires 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 investments we make. Finally, our organization takes it very seriously the recent racial injustice events and the considerable health inequity that still exists as highlighted by the COVID-19 crisis. Now more than ever, we are focused on advancing our broader purpose as an organization as we aim to pioneer science for the betterment of humanity. This includes doing the right thing for patients, our employees, the environment and the community; all of which we believe contribute to long-term sustainable shareholder value. This also includes accelerating our efforts in diversity and inclusion across the organization Biogen was already taking a leading position from hiring to the way we conduct clinical trials and working to ensure that the most vulnerable have access to our therapies. I am proud of what Biogen stands for and I believe this approach positions us well to be a sustainable organization over the long term as we remain focused on being the leader in neuroscience to address the tremendous societal needs in this space. Again, I would like to thank our employees around the world who are dedicated to making a positive impact on patients’ lives, including ensuring access to our therapies during these challenging times. With that, we will open the call for questions.

As a reminder, we would appreciate if you can limit yourself to one question as there are a number of analysts on the call. Thank you.

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

Hey, great. Good morning, guys. Thanks for taking the question. Let me say Jeff it's been great working with you at Biogen. So my question is toward the recently announced Phase III pre-symptomatic Alzheimer study. Can you elaborate on the rationale of choosing BAN2401 over aducanumab? I guess what about that - how has that made it more attractive to initially move into the study? Is it the lack of required dose titrations or something else? Thanks a lot.

Cory, this is Al Sandrock. I actually heard every third word of your question. So I'm not sure, but I think you were asking about BAN2401 in preclinical Alzheimer's disease and perhaps comparisons to aducanumab. If that's true, then I would say that, yes, BAN2401 and aducanumab are very similar antibodies. They both prefer to bind to aggregated forms of a-beta and they both show robust effect on amyloid PET imaging and also both have shown a reduction in clinical decline in Phase II or Phase 1 and Phase III trials. We have - we're very excited that our partners at Eisai are initiating this clinical study with the Alzheimer's Disease Clinical Trials Consortium. I believe that starting earlier is the best approach for - it turns out for all these neurological diseases and so we look forward to seeing the results of that. I'm not sure I heard your question but I hope I answered it.

So we did support the preclinical study with BAN2401 while we focused on the filing for aducanumab. We will revert back on lifecycle management opportunities during the entire continuum of the disease for patients once we have a readout and answer from the FDA on how we move forward.

Our next question comes from the line of Geoff Meacham with Bank of America.

Hey, guys. Thanks for the question. Jeff also want to say it's been great working with you. Another one on aducanumab. I know the next decision is - the next step is a decision from FDA. But when you look at ENGAGE versus EMERGE, just wondering if you could go into any detail of the analysis over, say, the past six months to nine months that you guys have done with the FDA, whether that could be published or at a medical conference or anything that you can share with us in terms of what the developments have been over the past pretty much six - since the beginning of this year. Thank you.

So Geoff, just to make sure we get the gist of your question, you are asking more about the timing over the next few months?

No, no, just the quality of the analysis and the details of the data analysis for aducanumab in support of the filing.

Well, I'm not sure I heard your question, Geoff. But I think - look the filing is based on these studies; EMERGE, ENGAGE and PRIME. EMERGE is the first study to show an effect, not only on the primary endpoint but all three pre-specified secondary endpoints. We believe that data from ENGAGE, that portions of the data from ENGAGE, a negative study, that portions of it do support the analysis that we did with EMERGE, and then - and also PRIME, which was published shows even though the clinical endpoints were exploratory endpoints on the highest dose, there was an effect on MMSE, as well as CDR-Sum of Boxes. And again very similar that the lower doses did not show much of an effect. So consistent with the findings from ENGAGE and EMERGE, you really need to get to the higher dose. And I think our data are all consistent with that.

Okay. Thanks, Al.

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

Hi, guys. Thanks for taking my question. I guess if I may focus on TECFIDERA, VUMERITY for a second. Michel, you mentioned you're working on two lifecycle management programs for PLEGRIDY and TYSABRI, but I feel like the most important lifecycle management program that's been on the market for a few months but has been a complete laggard has been VUMERITY. And my question is, why is that and why is almost every single precedent on lifecycle management capturing well above 25% share and up to 80%. I would just love to hear your take on commercial perspective on what happened on this?

Yeah, thank you for the question. And I share the disappointment for the performance to date on VUMERITY and you can anticipate that based on the patent life that we have, we are working on lifecycle management opportunities for the long run. We did launch VUMERITY in December and we had encouraging platforms start forms and then COVID came, and this impacted significantly the patients' new starts and the switches. So we did not anticipate when we launched in December that three months down the road, there will be COVID. And at that time, you will remember because you asked few times the question, the strategy was not a switch strategy, it was a fumarate strategy to enhance the share of the fumarates and the results are not bad. But this is not an excuse for the lack of performance to date of VUMERITY, for which the US organization is all over it. So what it shows is that it's difficult, it's challenging to launch. When there is a shutdown, it is challenging to change your behavior when you cannot meet the prescriber. Having said that, now the entire focus is pivoting on VUMERITY, and this is the good time because we have a very good access, close to 90%. We increased significantly the resource allocation. This is a next-generation fumarate with good data. Fumarate is differentiated as you know in terms of GI tolerability. It doesn't mean that all the patients on TECFIDERA could benefit from VUMERITY because those who are stable should stay on TECFIDERA, but it is a significantly enhanced focus of the organization on one brand, VUMERITY, the new generation fumarate and the next month should speak. So, we don't give up, and you should not.

Our next question comes from the line of Marc Goodman with SVB Leerink.

Yes, good morning. Jeff, I was wondering if you could talk about the SG&A guidance. It looks like it's $300 million less than it was before. There has been no change in the ramp-up in your spend commitment for adu in the second half of the year. So, where are the cuts coming from? Thanks.

Thanks, Marc. So, in this pandemic, we've found that - obviously, there's much less travel going on, much less conferences, meetings and other discretionary spend. And so, the vast majority of that difference in guidance is due to the fact that we have significant savings in the second quarter, and we anticipate that those savings will continue in the back half of the year.

Our next question comes from the line of Jay Olson with Oppenheimer.

Hi. Thanks for taking the question. Since you submitted the aducanumab BLA in a modular fashion, can you comment on whether the FDA began enrolling review of those modules or if they waited until the entire BLA submission was completed before initiating their review? Thank you.

Well, I don't want to comment on FDA's internal processes. It's true that we did submit modules as they became available to submit. And so, they've had some modules for some months now. But whether or not they reviewed them? I don't, you know. That's FDA internal processes and I can't comment on it.

Thank you.

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

Hey, good morning. Thanks, and congrats on the progress, particularly, Al, with the filing. Those were unprecedented. Maybe, Al, can you just comment on a simple question about how you think about priority review and whether or not there is any reason it would not be and whether or not you guys logically used a voucher? And then you made a nice comment about Europe, how you're preparing there to file. So, is that actually, you've had a discussion with them, and you've gotten sort of a similar agreement? Just comment there on Europe. Thank you so much.

Speakers, you may be on mute.

I'm not on mute.

And our next question will come from the line of Terence Flynn with Goldman Sachs.

Great. Thanks for taking the question. Maybe a two-part for me. I was just wondering, Jeff, if you can comment on what drove the change to the revenue guidance, anything more specifically? And are you assuming SPINRAZA is going to grow in the back half of the year? And then I was wondering more broadly, maybe a question for Al. If you can confirm that IQVIA was the CRO for the ADU Phase III trials? I'm just wondering how involved the company was in the filing process and if they were party to the discussions with the FDA? Thank you.

Hi, this is Al Sandrock. I'm not sure Michael heard my answer previously, so I'm going to repeat it. On the priority review question, we do have a voucher. We received one when we got nusinersen approved. But we haven't commented on how we're going to use it, when we're going to use it. We do expect to hear about whether or not we have priority review at the time the FDA notifies us of the acceptance of the filing, and so we'll leave it at that. In terms of the ex-US regulators, I think that was the second part of your question. We have engaged formally with the EMA, and we were in the process of preparing a filing for the European submission. And we have had also informal interactions with the Japanese regulators, and we're preparing that filing as well.

So, maybe moving to Terence's question on kind of what drove the difference in guidance. I'd point you back to the first quarter where we left guidance the way it was before, even in light of the COVID pandemic and with the view that we wanted to see how things played out. Now, as we sit here at the end of July, we've got a better sense of what the impact was on the second quarter and it was both the unwind of the activity from the first quarter, which we described, plus some headwinds in some businesses still like SPINRAZA and TYSABRI. We expect some of those headwinds to continue into the back half of the year. So, the vast majority of the difference in guidance is due to kind of continued COVID impact, which was difficult to predict when we did the guidance. But I would also point out that we did see a significant strengthening of the business through the months of the second quarter, particularly if you look at US SME business, where April was a very challenging month and then we saw a strengthening in May and then significant strengthening in June. So, another comment would be, we went with a fairly wide range because we're still kind of assessing how quickly it comes back. So, big difference is the COVID impact for the full year with post guidance down, but we did see a strengthening in SPINRAZA, which was encouraging. So, we'll have to see how all of that plays out. And then I think there was a question on IQVIA. Yes, IQVIA was the CRO that helped us to conduct the Phase III trials of aducanumab. However, they were not involved in any of the regulatory interactions that we've had with the FDA.

Our next question will come from the line of Matthew Harrison with Morgan Stanley.

Great. Good morning. Thanks for taking the question. One Al, could you just clarify on the comment you just made around priority review voucher. It sounds like you're not willing to say whether or not you use it to file for adu. And then secondly, can you just comment on anti-LINGO? What will you view as a positive result from that study or what do you need to see to move that into Phase III? Thanks.

Hi, Matthew. Yes. So, in terms of the prior - it's right, we're not - we're not willing to comment on whether or not we've used our Priority Voucher. And in terms of anti-LINGO, the primary endpoint is the overall response core, which looks - which is a four components score, looking at walking, EDSS and 9-hole Peg Test in the dominant arm and 9-hole Peg Test in a non-dominant arm. So, four components. And we're looking at whether or not patients overall improve. Because as you know, MS affects different parts of the central nervous system and at times you can have improvement in one area and worsening in another. So, we wanted to know whether or not, overall, the patients improved. In addition to that, of course, we're going to be looking at imaging measures related to myelination. So, for example, Magnetization Transfer Ratio, MTR, is a good measure of myelination and we'll be looking at that. So, in addition to the clinical, we'll be looking to see if we have biological measurements that are consistent with myelination.

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

Good morning, everybody. Congratulations on nice results and thank you for taking the question. You have presented before the submission there of aducanumab various of the patients. And you discussed with us the idea that you've done the same and even more advance with the FDA. I was wondering if you can share with us what is the primary patient cut used for the review, is it total set of patients all those who received certain number of high doses versus placebo? And to the extent you can answer that, I was wondering if you can share anything instead, if you're using copay and rebate differences to drive the adoption of VUMERITY going forward or is it just a difference in the educational focus of the organization?

So, Ronny, I'll take the first part. So, we submitted all the data from those three studies that I mentioned, EMERGE, ENGAGE and PRIME. And what the FDA chooses to look at is, that's their purview. I will say that in terms of the negative study, ENGAGE, we do - we have analysis that show that those who received the highest dose over a sustained period of time do show evidence of efficacy similar to what we found in EMERGE. And so, that's the data we presented to CTAD and ADPD and that's why we believe there are supportive evidence coming from ENGAGE.

So, concerning the second part of the question on VUMERITY, since the focus now is on VUMERITY not on the fumarate, I can tell you that all levels are aligned, at the payer level, at the patient services level, at the salesforce level - including incentive schemes -- to shape their behavior, at the medical affairs level. So, the organization is absolutely aligned and focused on all of those levers. Next five months will be critical.

Thank you.

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

Good morning. Thanks for taking my question. Jeff, let me add my well-wishes as you move on to your next opportunity. Thanks for the help over the years. Question for you, Al. In the prepared remarks, you suggested that the FDA in the pre-BLA meeting noted that the submission of aducanumab based on the three studies is reasonable. I'm curious whether you can provide any more detail on the pre-BLA meeting, what topics were discussed, what feedback did you receive and maybe in particular did the FDA indicate whether an Advisory Committee would be likely? Thanks.

Hi. Yes, so, it's our policy not to talk about the content of our regulatory interactions. So, I'm not - I'm not prepared to go any further than what I said in my prepared remarks. In terms of the Advisory Committee, it would not be unusual for the first disease modifying therapy of this type to be reviewed at an Advisory Committee. So, we are starting to prepare for one. Whether or not we have one and when it will be, will be up to the FDA. And we expect to hear that at around the time that we notified of whether or not the files has been accepted.

Great, thank you.

Your next question comes from the line of Tim Anderson with Wolfe Research.

Thank you. I have a question on aducanumab. Tau as a biomarker, which in Alzheimer's has really risen in prominence over the last few years. These are measured as tests, or if you remember, CSF. The amount of tau biomarker data you collected in ENGAGE and EMERGE was quite low in the context of the size of those few trials. And I'm wondering what FDA's feedback has been to you on this in terms of potentially wanting more tau biomarker data? My understanding is that the new EMBARK study, you are capturing tau on everyone. I think that includes tau imaging. So, any commentary on that would be helpful. And then, you guys have been willing to disclose you've asked for priority review. What I haven't heard you talk about is whether you've requested breakthrough therapy designation, which is arguably a better litmus test for how FDA views the data we have. Thank you.

So, Tim, you're right that tau has risen in prominence as an important biomarker and perhaps drug target in Alzheimer's disease. And that's because if you look at what correlates best with clinical progression, tau accumulation seems to do so. However, our - and our belief is that there is an interaction between amyloid beta and tau. And it's possible that tau could be triggered - tau misfolding and spreading could be triggered by a number of factors, trauma for one. But it could be that amyloid beta also does. And our data would be consistent with that in the sense that when we lowered, we use aducanumab, which is specific for amyloid beta and we see downstream effects on tau, both by imaging and by CSF. And the reason why it's not that many patients is that, first of all, it's hard to convince patients to undergo a lumbar puncture twice or - and also we were introducing a new tau PET imaging ligand, and we're already imaging patients with - for amyloid. So, having to do two PET scans, two different types of PET scans is a lot to ask for patients. But we do think we have adequate data to show a convincing effect on tau, not only in the CSF but also by imaging. And I've now forgotten the second part of your question.

Breakthrough.

Oh! Breakthrough. Yes, well, we do have fast track status and we expect to hear about a priority review. And with the fast track status., we have the opportunity to engage with FDA. And I'll say that we've-- we very much appreciate the level of engagement we've had, essentially since last June, where we've had a number of constructive, collaborative interactions with FDA.

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

Hi, there. Thanks so much for taking my question. Question on SPINRAZA and SMA dynamics. What would you guys be looking for out of the new study in combination with gene therapy? Is there any sort of bar from reimbursement perspective that one might expect for a combo use? And then, can you comment on any additional commercial prep or evolution and strategy had a potential entry of an oral? Thanks.

Well, the reason for doing - I'll take the first part, Brian. The reason for doing this study is mainly because, A, clinicians are already doing it, but there's no data from the study on whether or not it's helpful to patients. In fact, the European Journal of Pediatric Neurology just published a consensus statement of European experts in SMA. And they point out that there's a real lack of data on the use of this combination therapy and they called for more studies on it, and so, we're happy to be doing one. And the key question is, do you see improvement beyond what you see with just one therapy alone when you add SPINRAZA to Zolgensma or Zolgensma to SPINRAZA. And so, it's really looking at a motor milestone, whether you maintain them better, whether you gain more and more motor milestones. So, it's really mostly about efficacy.

And I think that it's a very good to help clinicians prioritize which therapeutic option to use based on research and not based on speculation or claims. If you look at the competitive landscape, for realty plans, it's still hard to speculate because there is no labor yet. FIREFISH was pretty consistent, SUNFISH was underwhelming in terms of achieving the objectives. When I speak to scientific leaders, their position is we need to wait for the long-term safety and efficacy profile of the product. And for the gene therapy, I think we have a profile that starts to be well characterized. And if I refer back to the latest consensus published in the European Journal of Pediatric Neurology, there is still uncertainty for the older population behavior, the infant ease. And they see a link with the potential risk to the wait. So, the scientifically those basically encourage at looking at all the options. For Biogen, we stand behind the efficacy and safety of SPINRAZA in all age groups, and we have a larger body of evidence. The product is approved now in 50 countries. So, we believe that SPINRAZA will continue to be really a very good treatment and alternative in this context, where there is a bit more treatment in this market, which is good for the patients. So, we are working to enhance the efficacy by increasing the dose. I'm not sure others can do that. And last but not least, there is the response study after gene therapy. So, I think it's good in order to best educate the market. So, we are confident.

Thanks, Michel. Thanks, Al.

We have time for two more questions.

Your next question will come from the line of Evan Seigerman with Credit Suisse.

Hi, all. Thank you very much for taking my question and congrats on the progress. So, in the press release out last night from Mike's appointment, it was clear that you emphasized his expertise in value creating strategic financial considerations. Should we read this as an evolution to more or larger transformative business development as under Jeff's leadership there was only really one major deal, which was the Nightstar acquisition?

Well, together with Jeff, we delivered on 18 deals. And remember, we believe we have an inequity in the space where we are specialized. So, the sweet spot is early stage. This is where we can add most value. And I am delighted to see this portfolio maturing extremely well with very important readouts in the coming 12 months and beyond, that will start to impact the market 2024, 2025. And in between now and the '24, '25, there is one big hope, which is aducanumab. So, I can tell you that we continue to be very active on the BD M&A front. But at the same time, we are very careful while we approach aducanumab potentially. And we will always invest in the interest of the long-term shareholder value creation.

Great, thank you.

Our final question will come from the line of Robyn Karnauskas with SunTrust Robinson Humphrey.

Great. Thanks for taking my question, and thanks, Evan, for the segue. So, I want to ask about the Phase III STAR trial for choroideremia. You've got data coming up, you'll be first. Walk us through what the bar is, and then what would be the best-case scenario to secure the best reimbursement for the drug? And then, what would be the next steps to be able to treat even younger patients with the disease as many people get it when they are very-very young? Thank you.

Hi, Robyn. This is, Al. Yes, so the BIIB111, which is our gene therapy for choroideremia, the Phase 3 trial is about 160 patients and the primary endpoint of the bar, as you point out, is the proportion of patients who have a greater than 15 letter increase from baseline in the best corrected visual acuity. That's the FDA standard. It's a two-arm trial, placebo. And so, we just need to have better improvement in visual acuity in the treated patients versus the non-treated patients. This trial was initiated in December of 2017. We announced our last patient in November of 2019. And so, we do expect to read out in the first quarter of next year. And the Phase 3 trial is on the heels of a Phase 1 trial, which was a single-arm study and it compared the proportion of patients who had an improvement in best corrected visual acuity relative to a natural history study and the drug did show some very encouraging results on that endpoint. So, we're just basically using the same endpoint for Phase III and trying to hit the standard set by the FDA. Thank you. I'd like to hand it over to Michel, just for some closing comments, please.

Thank you so much, Joe, and thank you for attending. I want to thank Jeff again for his many contributions to our company. At Biogen, it's all about pioneering in neuroscience. So, we are approaching a very exciting phase of our 40 years plus of development. Our pipeline and all the many allocation of capital in that space is maturing. We have very important readouts in the coming 10 months. We have seven Phase III and we are very close to open a new page, if FDA allows, with aducanumab. Thank you all for your attention.

Ladies and gentlemen, that will conclude today’s call. Thank you all for joining and you may now disconnect.