Biogen Inc.

Good morning. My name is Katie, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Biogen second quarter 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 1 on your telephone keypad. Please limit yourself to one question to allow 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 call over to Mr. Mike Henke, head of investor relations. Mr. Henke, you may begin your conference.

Good morning, and welcome to Biogen's second 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 a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. GAAP financials are provided in tables one and two, and table four 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 how we manage the business internally. We have also 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, we are joined by our Chief Executive Officer, Michelle Vounatsos, Dr. Priya Singhal, Interim Head of Research and Development, and our CFO, Mike McDonald. 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 Michel.

Good morning, everyone, and thank you for joining us. Biogen continued to execute well in the second quarter, and we are pleased to be raising our full-year financial guidance. We believe our achievements are critical steps on our path to drive renewed value creation for both patients and shareholders over time. Together with SI were granted priority review for leucanumab under the accelerated approval pathway in the U.S. for early Alzheimer's disease. We expect an FDA decision by January 6th of next year, and in parallel, we look forward to the upcoming phase three readout expected in the fall. Additionally, together with SAGE, we reported data in postpartum depression, The Skylark study is now the second positive phase three study supporting the potential in PPD, with four additional positive randomized controlled trials in major depressive disorders. We believe there is a substantial body of evidence support a significant opportunity for ziranolone. Pursuit of innovation, however, does not come without setbacks, and we were disappointed to learn that the B104 Phase II study in schizophrenia was not positive. I will now focus on the near-term operational priorities we outlined in our last call, while Priya will review our recent progress in R&D, and Mike will discuss our second quarter performance. First, we are continuing to focus our R&D resources on programs where we see the greatest potential while also aiming to rebalance the risk profile across our pipeline. For example, we intend to accelerate the regulatory filing of zuranolone in postpartum depression following the positive SCALAC study. In addition, we have terminated some R&D programs that we believe have lower probability of success, such as BIP076, an anti-Tau antibody in Alzheimer's disease, and BIP100, a small molecule of SPO1 inhibitor in ALS. Second, we are on track to implement the cost reduction and productivity measures outlined on our last call in order to further align our costs with our revenue base while maintaining our focus on execution. Third, we are pursuing additional global growth opportunities with a focus on key emerging markets. This includes China, where we are encouraged by the launch of Spinraza. Fourth, we are focused on driving renewed growth in our biosimilars business. We just recently launched BioVis, the first biosimilar referencing Lucentis in the U.S., representing Biogen's first entry into the U.S. biosimilars market. We also expect to begin launching BioVis outside the U.S. early next year. With the completion of the sales of our joint venture interest in Samsung BioAPs in the second quarter, We now have an expanded to pursue the biosimilar business on our own, as we aim to bring more biosimilar products to more patients' geographies. We continue to advance our biosimilar pipeline, which includes two phase three programs referencing ILEA and APTEMRA. Fifth, we remain focused on capital allocation during the quarter. We entered into new collaborations with Medrhythm, EMS, and Alectos in Parkinson's disease, and we continue to evaluate both internal and external value creation opportunities. We also return approximately $500 million to shareholders during the quarter through share repurchases. We are also pleased with the progress in our collaboration with Gentec for Mosin-itezumab. a CD20-CD3 bispecific antibody, which was recently approved in the EU for patients with relapse of refractory follicular lymphoma. The BLA of modulantizumab medication was recently granted priority review by the FDA, and we look forward to a potential approval in the U.S. Our progress across these areas, in addition to the recent advancements we have made in R&D, have the potential to have growth over time. Of course, not all our programs will deliver the results we hope, which is why we are continuing to advance a diversified and appropriately balanced pipeline as we work to create and sustain a multi-franchise portfolio over time. This includes near-term opportunities in Alzheimer's disease and depression, followed by other areas such as Parkinson's disease, lupus, and stroke in the mid to late 2020s. We remain committed to taking advantage of all the strengths of the company, our talent, our portfolio, our manufacturing capabilities, our pipeline, which includes 10 programs in phase three are filed, and our strong balance sheet to deliver results for both the patients we serve and our shareholders. I will now turn the call over to Priya for an update on our recent progress in R&D.