Biogen Inc.

And ladies and gentlemen, please stand by. Good morning. My name is Jake and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen fourth quarter and full year earnings call and financial 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. If you would like to ask a question during this time, simply press star one on your telephone keypad. Please limit yourself to one question to allow other participants time for questions. If you require any further follow-up, you may press Star 1 again to rejoin the queue. Thank you. I would now like to turn the conference over to Mr. Mike Henke, Director, Investor Relations. Mr. Henke, you may begin your conference.

Thank you, Jake. Good morning, and welcome to Biogen's fourth 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 our GAAP financial measures, and 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 4 includes the reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted slides on our website that follow the discussions related to this call. I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. On today's call, I am joined by our Chief Executive Officer, Michelle Vounatsos, Dr. Al Sandrock, EVP, Research and Development, and our CFO, Mike McDonald. I will now turn the call over to Michelle.

Good morning, everyone, and thank you for joining us. I would like to start by thanking Joe Marra for his excellent contribution to Biogen during the past 14 years, and also congratulations for his well-deserved promotion. At the same time, I am delighted to have Mike Encke stepping into the role. As we have announced last week, the FDA has extended the review timeline for aducanumab in the U.S., to June 7th. We are committed to working with the FDA as it completes its review of the aducanumab application, and we continue to stand behind our clinical data. We believe our results support approval. Let me now review the year. 2020 was a year of uncertainties due to COVID-19 for both society at large and also for our industry. and I am proud of what the Biogen team delivered. For the full year 2020, Biogen generated $13.4 billion in revenue, representing a 6% decrease year-over-year as we are experiencing the erosion of TechFedera revenue in the U.S. due to the impact of generic entry. Full year 2020 non-GAAP earnings were $33.70 a share, a slight increase versus full-year 2019. Now, let me review our progress against our strategic priorities. First, full-year MS revenues, including OCRVS royalties, were $8.7 billion, a decrease of 6% versus the prior year. Excluding TECFIDERA in the US, our global MS revenue remained relatively stable for both Q4 and the full-year versus 2019. Despite the challenges of launching a new product during COVID-19, we were pleased to see strong improvement in trends for Humerity, which has become the number two MS product and the number one oral in terms of new prescriptions in the U.S. We believe these results demonstrate our ability to maintain leadership and execute well despite increased competition, the erosion of tech federal revenue in the U.S., and COVID-19. Second, Spinraza generated full-year global revenues of $2.1 billion, a 2% decrease versus the prior year. Q4 global revenues were stable versus Q3. While Spinraza is facing increased competition in the U.S., which has been exacerbated by the impact of COVID-19, this was offset by continued growth outside the U.S. We remain committed to further exploring the potential to enhance outcomes for patients with Spinraza. This includes the devote study testing a higher dose as well as the recent initiation of the response study evaluating Spinraza in patients with a suboptimal clinical response to gene therapy. There are important questions that remain unanswered on the other approved treatment options. and we are committed to generating relevant data to further inform treatment choices. We believe that Spinraza will remain a foundation of care in the treatment of SMA. Third, biosimilars delivered solid performance despite continued COVID-19 impact with the revenues of $796 million for 2020 which represents 8% growth year over year. We estimate that the use of our biosimilar generated approximately 2.4 billion euros of savings to the European healthcare systems in 2020, which should help expand access and create headroom for new innovation. We also made important progress towards potential geographic expansion and future growth for our biosimilars business with the filing of SB11 referencing Lucentis in the U.S., where over the next five years, biosimilars are expected to generate over $100 billion in savings. Fourth, 2020 was a very productive year for our R&D organization. Last year, we submitted regulatory filing for Dukanuma in the U.S., EU, and Japan. We remain ready to launch aducanumab in the US if and when it is approved. Our teams have evaluated the availability of specialists, infusion capacity, the ability to confirm the pathology of amyloid beta, MRI capacity, and formulary approval processes. We believe there are several hundred sites in the US that are ready to start treating patients should aducanumab be approved. Beyond aducanumab, we addressed or advanced 12 new clinical programs last year across MS, ALS, Parkinson's disease, depression, and biosimilars, including four in phase three. Importantly, we entered new strategy collaboration with Sage and Benally. providing access to potential first-in-class therapies for serious neurological disorders such as depression and Parkinson's disease. Our collaboration with SAGE has important late-stage diversification through phase three programs in both major depressive disorders and postpartum depression with critical readouts expected this year. An asset in depression would offer multiple synergies across Biogen's existing portfolio. Overall, in 2021, we expect eight need-to-late-stage data readouts, including four programs in Phase 3. Fifth, our cash flow generation continues to provide us with significant flexibility to allocate capital. During 2020, we returned approximately $6.7 billion of capital to shareholders and allocated roughly $3 billion for business development to enhance our pipeline. In summary, 2020 was a very productive year for the company as we have executed on our strategy. Despite the challenges from COVID-19 and tech federal generics, we have maintained global leadership across our core businesses in MS, SMA, and biosimilars, and we have made significant progress towards building a multi-franchise portfolio. As Mike will outline with our guidance, we believe 2021 will be a reset year for the company financially on both the top and bottom lines, but we believe we can grow the company over the long term. As we have demonstrated in the past, we are committed to maximizing returns for our shareholders as we aim to bring innovative therapies to patients. I will now turn the call over to Al for a more detailed update on our recent progress in R&D.