Good morning. My name is Lisa, and I’ll be your conference operator today. At this time, I would like to welcome everyone to the Biogen First 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 conference.

Good morning, and welcome to Biogen's first quarter 2020 earnings call. Before we begin, I encourage everyone to go to the Investors section of the 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. 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. I want first to acknowledge the challenging situation the global COVID-19 pandemic has created for so many people. Our hearts go out to everyone who has been impacted. We applaud the way our employees and everyone across the entire health care system is breaking down barriers and working together to address this pandemic. And we are committed to doing our part to support communities worldwide. At the same time, we are also committed to learning from the current situation and working to develop innovative new operating models, such as accelerating our digital capabilities which we believe will better position Biogen for the future. During these challenging and unprecedented times, Biogen’s mission and purpose remain the same. Over half a million patients around the world rely on us today to supply important medicines for serious diseases and there still remains an urgent need to develop innovative therapies for the millions of patients suffering from devastating diseases of the nervous system. Let me now provide you with an update on how we are operating our business throughout the pandemic. First, I would like to recognize the resilience and the adaptability of the Biogen team. Biogen personally felt the painful impact of these global crisis as many of our employees became sick early on and orders have since been affected. We have been fortunate that as of today all of our employees have recovered or are recovering. Most of our affected employees have continued to work and fulfill their duties. We are grateful to the public health authorities for all they have done and we are also thankful for the courage and compassion of the health care workers who have been helping us and continue to support so many. We took a number of…

Thank you, Michel. And good morning, everyone. Before I begin let me first take a moment to say how proud I am of the way the R&D organization has stepped up in response to the COVID-19 pandemic. I'm inspired by their resilience and their unwavering commitment to our patients. Let me now review the steps we have taken within R&D. In line with recent global regulatory guidance, we have developed a set of principles to guide our clinical trial conduct under these exceptional circumstances. First, the safety of all of our clinical trial participants and our health care providers, as well as the integrity of the data we collect will remain paramount. Second, given the importance of our clinical trials to patients with serious diseases, we aim to continue our ongoing trials, as long as the risks to patient and healthcare provider safety, as well as data integrity can be sufficiently mitigated. Third, we are generally allowing enrollment of new patients, sites and countries into ongoing clinical trials. However this may be stopped on a study by study basis if such enrollment compromises our ability to mitigate risk to patient and health care provider safety and data integrity. Fourth, we may allow for the initiation of new clinical studies on a region by region basis, as long as the risk to safety and data integrity can be sufficiently mitigated. However, we are implementing a limited pause on the initiation of new clinical trials evaluating molecules which suppress the immune system or specifically modulate antiviral responses with a reassessment in the coming months. This includes pausing the initiation of the planned Phase III study of the pegylated anti-CD40 ligand fab in systemic lupus erythematosus in collaboration with UCB. And fifth, we are reviewing informed consent forms from all studies to ensure…

Thanks, Al. Good morning, everyone. Prior to starting my comments on the financial performance, I want to highlight that we believe the fundamentals of our business are strong and we are well-positioned. Our products are important therapies for patients living with serious diseases. We have strong operating process, enabling us to operate effectively through these challenging times. We also pride ourselves in our ability to execute well commercially. In addition, we are well capitalized financially. These are however unprecedented times that will have an impact on our business. I will now review our financial performance, highlighting the various factors to give you a sense of our performance and then wrap up with commentary on our outlook. I'll start with our revenues. Total revenues for the first quarter grew 1% year-over-year to approximately $3.5 billion. It's important to note that we believe Q1 benefited from approximately $100 million attributed to accelerated sales due to COVID-19 pandemic, primarily in Europe. As a reminder, Q1 2019 included a benefit of approximately $200 million in other revenues due to the sale of hemophilia inventory to Bioverativ. Overall, we executed well in our MS business, delivering revenues of approximately $2.3 billion in the first quarter of this year, including OCREVUS royalties of approximately $162 million, growing 9% versus prior year. Global MS revenues in Q1 2020 increased 7% versus the prior year without OCREVUS royalties. US MS revenues excluding OCREVUS increased 4% or $58 million versus the prior year. US MS revenues in Q1 2020 were impacted by a decrease from channel inventory of approximately $115 million compared to a decrease of approximately $170 million in Q1 2019. We estimate that we had $54 million in additional sales due to a greater number of shipping days in the quarter. Roughly half of which impacted the…

Thank you, Jeff. I am incredibly proud of how the Biogen team has responded to the current situation. Our employees all around the world have demonstrated their resilience and dedication to advancing our mission, as well as their compassion and empathy in wanting to be part of the solution to this terrible disease. Our business has remained strong. We delivered solid financial results in the first quarter and we have demonstrated a GDP in adapting many aspects of our operations, including the conduct of most of our clinical trials. While do we do anticipate some risks to our business as a result of the pandemic, we believe our opportunities for value creation remains compelling, given the significant unmet medical need in the diseases we are pursuing. With a strong core business in MS, SMA and biosimilars, we believe we have the foundation to continue building a multi-franchise portfolio. We believe the vast majority of our 10 data readouts remains on track to complete before the end of 2021. Importantly, we have made good progress on the aducanumab filing and we are actively preparing for potential commercial launch, as we are getting ready to lead the fight in Alzheimer's disease. 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 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. Our response to this current situation exemplifies 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, employees, the environment and the community, all of which we believe contribute to long-term sustainable shareholder value. I am proud of what Biogen stands for and I believe this approach positions us well to be a sustainable organization over the long run, as we remain focused on being the leader in neuroscience to address the tremendous societal needs in this space. Now more than ever, I would like to thank our employees around the world who are dedicated to making the positive impact on patients' life and all of the health care workers who are on the frontlines battling COVID-19. I have been truly impressed how the entire health care community has stood up in the space of this quarantine [ph] times. With that, we will open the call for questions.

Thank you. [Operator Instructions] And our first question comes from the line of Marc Goodman from SVB Leerink. Your line is open.

Yes, good morning. On the ADU filing, it just seems like there's been a change in the language a little bit with regards to the filing. I guess, everybody was kind of assuming that you had filed or were about to file and now it just seems like there was a delay. Can you give us a little more color on what's going on behind the scenes? Is it - is it COVID related? Is it a change in the language of what you're hearing from FDA? And then just secondarily, can you just give us a little more color on what you're talking about with the interactions in Europe and Japan as well? Thank you.

So thank you for the question that is the focus of the attentions of everyone and a priority within the organization. Again, we are on track and we are receiving input from the FDA and we are engaging very well. I would say, there are two main reasons. While it's taking a little bit more time and at the company we are prioritizing the quality of the submission versus the timing. We don't want to rush and then face challenges. So the quality is important and we have to keep in mind that there is an unprecedented dataset, plus COVID, okay? The database - database lock was in November and is very complex with more than 3000 - 3200 patients, multiple biomarkers and multiple endpoints. And if you couple that with we could be a one [ph] it makes a complex and unprecedented dataset. So I just want to put that upfront before Al build on that. Al?

Yeah. So can you hear me? So I just want to – I have to say that it's – look, timing is not easy to predict. We were trying to do that since the initial announcement in October and this is an unusual process. But I want to emphasize that we now have an open BLA. We've started to submit modules. We have continued constructive engagement with FDA and we believe we're on track in terms of the potential for approval. There's - I wouldn't read too much else into this. And in terms of your second part of your question, which I believe was Japan and Europe, we have started engagement. It's still kind of early relative to the process with FDA, but we have started.

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

Hi. Thanks for taking the question. Maybe just a follow up there, I was just wondering if you can tell us if the FDA has asked for any additional analysis of aducanumab data. And then Michel and Al, I would just be curious if your level of confidence in the dataset is the same now as when it was when you announced your intention to file for approval last year? Thank you.

So level of confidence remains the same. Al, will take the rest of the question.

Yeah. I would say that we are constantly doing analysis, but nothing really has changed in terms of - nothing has come up in the data that changes our interpretation of the data. Our view of the fundamentals hasn't changed. And I emphasize that we remain constructively engaged. These additional type C meetings are really to further engage with FDA. As we have been since the very beginning actually, starting last June when we had our first type C meeting.

And our next question comes from the line of Umer Raffat from Evercore ISI. Your line is open.

Hi. Thanks so much for taking my question Michel, a quick one for you and one for Al. Michel, you keep mentioning the word good progress on describing aducanumab, even though it seems like you now probably need a pre-BLA meeting which didn't sound like was the case previously. So can you elaborate on that. And Al, it seems like I'm just reading the [indiscernible] what you just said and it seems like you're having to run additional analyses, and that those might be the reason why additional meetings are happening with FDA. And I guess my question is has FDA previously shared feedback with you on the way you guys did imputations for non-completers because you might recall, the reason EMERGE [ph] hit on the high dose was because the effect size in the completers was assumed to be the same as non- completers and also the whole question around whether FDA would want you to pull the data, has FDA shared feedback? We're not asking what the feedback is, but has FDA shared the feedback with you on that?

So Umer, last time we had the opportunity to dialogue. We didn't have an open BLA. We didn't have to file to the FDA. So there is good progress. We had traditional type C meetings and you have to read here high interest from the FDA. So this is what we continue to qualify as being positive progress. Al?

Umer, I would just say that we had always planned to have a pre-BLA meeting with FDA. That hasn't changed. That was always in the planning. And look, some members of the team did get COVID and I can tell you it's hard to work when you have COVID. The fatigue, mental or physical fatigue was such that there were some people who were affected by the disease. So I think that - that's part of it, but I would say that most of it is that - I would say the main point is that nothing has come up with the data that has changed our interpretation. We believe EMERGE is a positive study. It was positive on the pre-specified primary and all three secondary endpoints. You know, I mean, we have done an analysis on ENGAGE to try to figure out why that result was different. But we believe that the fundamentals are the same and that the potential for approval remains the same as Michel said from the very beginning.

And if something would have change, we’ll communicate so.

Our next question comes from the line of Ronny Gal from Bernstein. Your line is open.

Hi. Unfortunately, we probably have to – thank you for taking the question. We’ll stay with the aducanumab theme. I guess the question is twofold. First one, have there been new questions that were raised by the data. I mean we all are familiar with some of the issues you've raised before and how you address them. But essentially as you kind of look on this and as the FDA now has an open BNA [ph] opportunity might have access to the data. Have new questions that have not been raised before raised by this? And second, should we expect you to present any more data from aducanumab during this year and any new analysis that you expect to present before we actually get to see the FDA review?

Ronny, this is Al. There really are no new questions today. You know, as I said earlier that the data you know, we haven't –come up with nothing that really changes our interpretation of the data. And so I would say that fundamentally there are no big changes and no new questions. And I would also say that we're not planning on presenting anything more publicly at this time, until - hopefully until approval. But that's our plan.

Our next question comes from the line of Phil Nadeau from Cowen and Company. Your line is open.

Morning. Thanks for taking my question. Again, sticking with the aducanumab theme, I guess a two part question. One is, just going back again to what has changed in the Q4 call. It sounded like you had said at that time all that need to happen was some submission of documents and there was no mention of additional type C meetings approved BLA meetings. So I guess, where we all mistaken that you still need to have those meetings and that was always part of the plan or did something come up again kind of asking the same question that prompted the need for those meetings? And then second, I think we were all trying to debate here as is the FDA is interested in aducanumab. I know you said that there's a high level of interest, but could you maybe give us some better sense of the FDAs current appreciation for the data and whether you can determine if there's controversy within the FDA about the quality of the results? Thanks.

Al?

Phil, this is Al, I just want to say that this is an unusual process. You know, this is unlike anything I've ever been involved with before my 22 years at Biogen. So - and the nature of this process has been collaboration from the very beginning from the type first type C meeting. So it's been a highly collaborative process, I would say and then you know yes, submission of documents is easier to say. But the BLA is pretty complex. There are multiple sections, multiple modules and so I know it sounds easy to pull together submission. But let me tell you it's not. And I think that - and it's been difficult to predict the timing partly because it's been an unusual process right from the beginning and we've always, you know, quite frankly we've been having type C meetings since last June and that hasn't changed actually that the fact that we're doing type C meetings has been the same since the very beginning. So those are the main points.

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

Thanks for the question. And if it hasn't been said before, hope you guys are very safe, you know, we all know how hard it's been hit and everyone in the financial community appreciates it. I guess my question is for Al, you mentioned in the pre-BLA meeting, I know this is coming up. Can you just maybe talk about what type of topics or key questions would be addressed there? And is it safe to say that additional subgroup analyses like positive versus negative and geographical differences, those type of analyses have been done and are all part of this package? Thanks so much.

Well, I would say that geographic issues, subgroup analyses, that’s standard practice for every single BLA I've ever been involved in. In fact, there are sections of the model [ph] that call for looking at data from the various geographies. So that's not - that's not different from any other BLA I've ever been involved in. At a typical pre-BLA meeting you go through - it's more like an operational meeting, you have various sections of the FDA that – they’re going to be involved in the review of the BLA. You sit down and you talk about how it's going to be submitted. What's going to be submitted exactly, and there's some agreement on the operational aspects of the actual submission. That's the typical pre-BLA meeting.

Our next question comes from the line of Jay Olson from Oppenheimer. Your line is open.

All right. Thanks for taking my question. It's great to hear you all well and I want to commend you for the work that you're doing to fight COVID-19. I had a question maybe a little longer term question about aducanumab. And as you begin to contemplate home infusion of TYSABRI, does that set the stage for potential delivery of aducanumab by home infusions and will that be done by Biogen employees or are you going to engage a third party to do that? Thank you.

Well, home infusion - the home infusion of intravenous drugs has been in place for decades. I used to prescribe some drugs by home infusion myself back when I practiced and so it's not uncommon, whether or not it will be done with aducanumab, we haven't disclosed yet, but it would not be something that would be difficult to imagine. It's a - it's a very well the infusions themselves are very well tolerated. So it would not be difficult to imagine that after approval.

Having said that, I think that launching a product in the post-COVID environment would be very interesting to assess, beyond I would say the normality of what we are preparing on many aspects, the ability to meet beyond digital channels face to face, how to engage, but also infusion and much more. And this we are getting ready. There are two dynamic going on, one is managing the lifecycle of well-established product. This is what we are doing, we are doing very well and launching a new product in a COVID environment is a challenge, in a post-COVID its still yet to be assessed.

Our next question comes from the line of Evan Seigerman from Credit Suisse. Your line is open.

Hi, all. Thank you for taking the question. I'm actually not going ask on aducanumab. I want to ask one, so yesterday there was an appellate court ruling on the 001 patent for TECFIDERA highlighting a potential launch of the banner monomethyl fumarate. Kind of how should we interpret this ruling? And if you were to lose one or both of the upcoming district court cases on TECFIDERA, how would you act to protect the franchise?

So Evan, this is Jeff. So you know the banner product is not a directly substitutable A/B product. So I think that's the first thing that's important to understand. So if and when it gets launched we don't think there'll be a significant impact at this point in time. And then with regard to the two court cases, obviously we were very pleased to get the favorable ruling from the IPR ruling and I think that's the third time that patent is stood up. So we think we've got a pretty strong patent position. However if we're unsuccessful with either the two district court cases, we've got VUMERITY as a product that we can kind of look at, is a fumarate strategy that we're looking at. We've got growth opportunities around the world in pretty strong results outside the U.S. We think SME has got good growth potential, BBU and then of course you've got the aducanumab potential as well. So you know, I think we’ve got a pretty strong franchise will grow around it.

Great. Thank you.

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

Hey. Good morning, guys. Thank you for taking the question. I guess, going back to aducanumab, I wanted to better understand what it means to submit modules for your BLA before having that pre-BLA meeting, was this - I guess was this always a rolling BLA submission, was that the intent all along just trying to understand the meaning and having this pre-BLA meeting we didn't think this was going to be necessary as of the last call? Thanks a lot.

Yeah. So Corey, this is Al. I - the common technical document is composed of various modules and there for example quality modules related to manufacturing process. There are non-clinical sections and then there's the clinical sections which culminates in a clinical overview which is - so there are summary documents of the actual study reports of individual clinical studies. And so those are the three main sections. And as you can imagine the non-clinical was you know, it was already kind of ready because not much has been done since - non-clinically since the early days. It still had to put together the actual documentation and so forth. So those are the - those are the sections of the common technical document. They're all submitted electronically and so - and look we had starting in around October or so we did start to contemplate submitting modules as they became available. That was our plan. But at pre-BLA meeting is still pretty common practice, as I said to get both sides Biogen and FDA to be agreed to have agreement on the operational aspects of the of the CPD. So I would not read very much into that as I said, we had planned to have that meeting from the very beginning.

We probably have time for about two more questions.

Thank you. Our next question comes from the line of Matthew Harrison from Morgan Stanley. Your line is open.

Good morning. Thanks for taking the question. Sorry to stay on aducanumab, but I'm really struggling with the commentary that you're giving this morning. So I was hoping maybe you could just talk about one specific thing. I mean I think your prior guidance was that you would have a filing in early 2020 and today you're talking about a 3Q filing which seems like a significant delay to me, yet your characterization seems like nothing has changed and you know sort of all of your expectations are in line. So it seems like there's a significant disconnect with the timeline versus your commentary and I'm just hoping you can maybe take a moment to explain to us what has happened. Thanks.

So our goal right from the very beginning was to try to provide estimates of timing of this filing since actually the announcement in October. But the timing is always not easy to predict. And in fact, as I said before this is an unusual process, so it's even harder to predict timing when you have a process that actually is pretty unusual and in my experience unique. I would just say that the constructive engagement though has been there since the very beginning that continues. These type C meetings are formal ways to have engagement with FDA, pre-BLA meeting is another formal meeting with FDA to continue on the path to approval. We have an open BLA and yes there's is a - we said early 2020, so now it's Q3, we did have some impact from COVID, but I would say that overall what we're saying is that the potential for approval we're still on track with that.

And our next and final question for the day will come from the line of Carter Gould from Barclays. Your line is open.

Good morning, guys. Thanks for taking the question and squeezing me in. I guess maybe different spin on the aducanumab question. Obviously we got Gantenerumab data, a DIAN-TU data in the quarter. Al, can you maybe provide your perspective on the appropriateness of reading through from the lack of cognitive benefit in that study to aducanumab and if these data have in any way kind of changed the conversations with FDA? Thank you.

Thanks, Carter. First of all, I want to congratulate Randy Bateman and all the investigators in DIAN-TU. I think it's a beautiful study. It's very hard to do because although they are - it's a homogeneous population in terms of they all have autosomal dominant Alzheimer's disease from the genetic and biological point of view, it's pretty heterogeneous in terms of clinical, they could be two decades, one decade, a few years prior to becoming symptomatic. So how do you pull data from that heterogeneous clinical collection? Also it's a relatively small study, 50 patients per arm I believe roughly. So the DIAN-TUlooked at both Solanezumab and Gantenerumab. Solanezumab had no change in amyloid PET based on imaging. And there was no effect. So that's not too surprising. Gantenerumab did have an effect on amyloid PET. However, I want to compare the magnitude of the effect between Gantenerumab and aducanumab. And the only way to do that really is to use the centiloid scale. The whole point of the centiloid was developed so that you can compare cross studies because people use PET ligands, people have different reference regions that they use to obtain the SUVR score. In the PRIME study, 10 milligrams per kilogram of aducanumab was associated with a change in the centiloid scale of about 57 in one year, in the DIAN-TU study, Gantenerumab was associated with a change from baseline of about 14 centiloid units over four years. So I think that's pretty different. And we were trying to make at the CTAD meeting is that dose matters and that the robustness of amyloid removal matters and we saw that in the data and I think we presented that. So in some ways I looked down at the DIAN-TU data and I think it kind of confirms what we have been saying that you have to have high doses and robust removal of amyloid in order to see a clinical benefit.

I’ll turn it over to Michel for some closing comments. Thanks, everybody.

So thank you all for attending the call. I would like to say that even if personally affected by this terrible pandemic, Biogen is demonstrating superb resilience. Biogen is even stronger today and we are well-positioned for the future starting with aducanumab, but also looking forward to all the important readouts in the coming period.

Thank you, everybody.

Ladies and gentlemen, thank you for participating. This concludes today's conference call. You may now disconnect.