Biogen Inc.

Good morning. My name is Jennifer and I will be your conference operator today. At this time, I'd like to welcome everyone to the Biogen third quarter 2022 earnings call 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. If you'd 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, Head of Investor Relations. Mr. Henke, you may begin your conference.

Good morning and welcome to Biogen's third quarter 2022 earnings call. Before we begin, I encourage everyone to go to the Investor section of Biogen.com to find the earnings release and related financial tables, including our GAAP financial measures and the 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 a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted slides on our website that follow the discussions related to this call. I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. On today's call, I am joined by our Chief Executive Officer, Michelle Vounatsos, Dr. Priya Singhal, Interim Head of Research and Development, and our CFO, Mike McDonald. As a reminder, during the Q&A portion of the call, we kindly ask that you limit yourself to one question. I will now turn the call over to Michelle.

Good morning, everyone, and thank you for joining us. This is an exciting time for Biogen. In addition to key developments across our pipeline, which includes 12 programs in phase three are filed. We continue to execute and we are pleased to be raising our full year financial guidance. I would like to begin by reviewing the important advances we made this quarter and what we believe they mean for Biogen. Priya will then review our recent progress in R&D and Mike will discuss our third quarter performance. First, together with ASI, we were excited to announce the positive results from ClarityID, the phase three study of leucanemab in early Alzheimer's disease. For over 15 years, Biogen has been working relentlessly to bring forward new therapeutics in Alzheimer's disease, incorporating both new insights in disease biology and clinical trial design. And today, we celebrate the positive clarity AD readout as a significant achievement in the treatment of Alzheimer's disease. The results from CLARITY-AD illustrated several key aspects of leucanumab's clinical profile, which we believe could provide a meaningful benefit for patients. First, leucanumab administration showed a highly statistically significant reduction in clinical decline as early as six months, which expanded over the 18-month study period on an absolute basis consistent with the disease-modifying effect. Second, the study was positive on all key secondary endpoints. This includes measure of cognition, as well as activities of daily living, such as conducting personal finances, performing household tasks, and independently traveling out of home. Third, the rate of ARIA in CLARITY-AD was within expectations. With an FDA decision on accelerated approval expected by January 6th of next year, and ASI's plan to file for traditional approval in the US, EU, and Japan by the end of Q1 2023, lecadimab has the potential to be the first globally approved treatment to slow the progression of Alzheimer's disease. We look forward to working with SI as they continue to engage both regulators and CMS with the goal of ensuring that people with Alzheimer's disease have access to important new treatments. We believe the clarity AD results underscore the progress we are making in the fight against Alzheimer's, but Biogen will not stop here. We plan to build upon our current learnings as we continue to advance a diversified pipeline of potential Alzheimer's treatments. This includes two clinical stage assets targeting tau pathology, BIB80, our phase II ready antisense oligonucleotide, and BIB113, a phase I small molecule. Beyond Alzheimer's, Biogen has important opportunities in other therapeutic areas where the unmet medical need remains significant. This includes depression, where together with SAGE, we are continuing to advance the regulatory filing for Zuranolone in both major depressive disorders and postpartum depression. With a novel mechanism of action, efficacy observed as early as three days, and a consistent safety and tolerability profile across eight clinical studies, we believe that Geradolin, if approved, could be a meaningful new therapy for depression. Second, the FDA has accepted our filing for Tofersen in SOD 1 ALS under the accelerated approval pathway and granted priority review. While the study did not meet the primary endpoint at six months, longer follow-up has shown that patients who remain on Tofersen experience a slow rate of decline in key clinical measures, including lung functions, muscle strength, and quality of life. We are truly encouraged by these results in such a debilitating and fatal disease and look forward to an FDA decision expected by April of next year. We believe these near-term opportunities, along with new launches of biosimilars, have the potential to drive renewed growth and position us to have five key franchises by 2025. Furthermore, we see the potential for additional growth drivers in the mid to late 2020s in areas such as Parkinson's disease, lupus, and stroke, all with programs currently in phase three. Overall, we believe that we are at an inflection point in CNS drug discovery and development, and these recent developments embody three advancements that are being made in neuroscience. For years, Biogen has been expanding our expertise and capabilities in this area And we believe that we are well-positioned to remain a leader in neuroscience as we work to usher in the new next wave of CNS therapeutics while also advancing our portfolio in specialized immunology where we have four late-stage studies in lupus. I will now turn the call over to Priya for a more detailed update on our recent progress in R&D.