10/20/2021

speaker
Shelby
Conference Operator

Good morning. My name is Shelby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen third quarter earnings call and financial update.

speaker
Operator
Conference Operator

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 1 on your telephone keypad. Please limit yourself to one question to allow all participants time for questions. If you require any further follow-ups, you may press star 1 again to rejoin the queue. Thank you. I would like to now turn the conference over to Mr. Mike Hinke, Investor Relations. Mr. Hinke, you may begin.

speaker
Mike Hinke
Investor Relations

Good morning, and welcome to Biogen's third quarter 2021 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 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. Today, we will be discussing Aduhelm, Aduhelm is indicated for the treatment of Alzheimer's disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial or trials. Aduhelm can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA. ARIA is a common side effect that does not usually cause any symptoms, but can be serious. Aduhelm can cause serious allergic reactions. The most common side effects include ARIA, headache, and fall. please see full prescribing information and patient medication guide at aduhelm.com. On today's call, I am joined by our Chief Executive Officer, Michelle Vounatsos, Dr. Al Sandrock, Head of Research and Development, and our CFO, Mike McDonald. We will also be joined for the Q&A portion of our call by Alicia Alimo, President of our U.S. organization, and Toby Ferguson, Head of Neuromuscular Development. 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 Michel.

Disclaimer

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