Biogen Inc. (NASDAQ:BIIB) Q2 2020 Earnings Conference Call - Final Transcript
Jul 22, 2020 • 08:00 am ET
Good morning. My name is Regina, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Biogen Second Quarter 2020 Financial Results and Business Update. [Operator Instructions]
Thank you. I would now like to turn the conference over to Mr. Joe Mara, Vice President, Investor Relations. You may begin your conference.
Good morning, and welcome to Biogen's Second 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 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 and our GAAP to non-GAAP financial guidance. 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 discussion related [Technical Issues]. 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'm 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. With a focus on strong execution, we have continued to assess patients, advance our strategic priorities and delivered another strong financial quarter. Let me begin with some important developments. First, we have completed our submission for U.S. approval of aducanumab, an unprecedented opportunity for patients and for Biogen to potentially bring to market the first therapy to reduce the devastating clinical decline and meaningfully change the growth of Alzheimer's disease. I am incredibly proud of the Biogen team for their dedication and tireless work leading to the completion of our regulatory submission on July 7. This submission followed ongoing collaboration with the FDA and includes data from a comprehensive clinical development program, including EMERGE, the first positive Phase III study ever in this space. Together with supporting data from the Phase III ENGAGE study and positive results from the Phase Ib PRIME study, our data show that aducanumab may help to both reduce the decline of cognitive function and help patients' ability to perform certain activities of daily living, which for some patients may result in independence for a longer period of time.
In terms of next steps, we anticipate receiving a response from the FDA within 60 days from the submission date, notifying us if the submission has been accepted, and if accepted whether we have been granted priority review. We plan to communicate both of these decisions via a press