Biogen Inc.

Ladies and gentlemen, good morning. My name is Abby 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. 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 one again to rejoin the queue. Thank you, and I would now like to turn the conference over to Mr. Joe Marra, Vice President, Investor Relations. Mr. Marra, you may begin your conference.

Thank you, and good morning, and welcome to Biogen's third 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 gap 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 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 Bonazzos, Dr. Al Sandrock, EVP Research and Development, and our CFO, Mike McDonald. Now, I will turn the call over to Michelle.

Good morning, everyone, and thank you for joining us. As you all know, the ADI-CADIMAB Advisory Committee meeting is scheduled for November 6th. This is our highest priority, and we are very focused on preparing for this meeting. At the same time, the tech federal situation in the U.S. is clearly a near-term challenge, which we will discuss. Before I continue, I'd like to welcome Mike McDonnell, our new CFO. Mike's background and track record of accomplishments make him well-prepared to be a very strong contributor to Biogen, and I know he looks forward to getting to know many of you. Now, let me review some key recent developments. First, we are very pleased that the FDA has accepted our BLA for aducanumab with priority review and has stated that, if possible, they plan to act early. As I mentioned, the advisory committee is, of course, an important event on the path to potential approval and we are actively preparing to participate and share our perspective on our clinical data. Outside the US, early this month, we submitted a marketing authorization application in Europe, and we are preparing for a regulatory submission in Japan following a recent formal meeting with the PMDA. We have progressed in our US launch readiness as we remain focused on appropriate engagement with scientific leaders treatment sites, defining aducanumab's value proposition, and establishing collaboration across multiple stakeholders to help prepare for the potential introduction of the first therapy to meaningfully change the course of Alzheimer's disease. Outside the US, we are continuing to ramp up our long-term readiness, particularly in Europe and Japan. Beyond aducanumab, we continue to advance our broader Alzheimer's disease portfolio, including BAN24-1 in Phase 3 and multiple programs targeting tau. Also in neurodegeneration, we are proud to be collaborating with Denali, a premier innovative neuroscience company pioneering novel approaches for treating brain diseases. This collaboration provides us a mid-stage small molecule LRRK2 inhibitor program, which expands our pipeline of potential therapies in Parkinson's disease across multiple modalities. We also received exclusive options rights to two programs for neurodegenerative diseases using the NALYS innovative transport vehicle platform, including for amyloid beta antibodies. With a deep pipeline, aducanumab now under review and our recent collaboration with Denali, we believe we are well positioned to lead in the fight against both Alzheimer's disease and Parkinson's disease, the number one and number two most common neurodegenerative diseases with an urgent need for novel treatments. More broadly, we have continued to develop and expand our deep pipeline which now includes 30 clinical assets, with eight in Phase 3 of FILED, including the recent initiation of the Phase 3 program for dapirolizumab, PEGOL, in lupus with UCB. As we have demonstrated in the past, we are committed to maximizing returns for our shoulders as we aim to bring innovative therapies to patients, something that demands a thoughtful approach towards all our investments, over both the short and the long term. Let me now discuss where we see Biogen strategically as we believe we are in a transitional period with several upcoming inflection points. As we manage through the erosion of TechFedera in the US, Biogen remains focused on strong execution against our strategy. We are the leader in neuroscience with differentiated core capabilities as we aim to leverage breaking science to address the tremendous unmet medical need in this space. We are leveraging better understanding of disease biology including the underlying genetics as well as advances in biomarkers such as novel imaging of the brain to help reduce the risk in developing therapies for many previously intractable diseases. We are building on a strong financial track record with a core business in MS, SMA, and biosimilars, and we believe we are entering a new phase of important clinical readouts and value creation opportunities. We will continue to work to maximize the potential of our broad MS portfolio, including the launch of Vumerity and lifecycle management for Tysabri and the Interference. Despite increased competition, we believe Spinraza can continue to grow and serve as a foundation of care based on the most well-established efficacy and safety profile in SMA. Spinraza has demonstrated sustained clinically meaningful benefit from pre-symptomatic infants to adults, and its safety profile has enabled us to begin assessing a higher dose for potentially even greater efficacy. We see biosimilar as another potential growth driver while providing headroom for innovation. We are working to expand into the U.S. and China with the potential to commercialize two new ophthalmology biosimilars with a global market opportunity of approximately $11 billion. Importantly, Samsung BioAPIS recently announced that a marketing authorization application was accepted by the EMA for SB11, a potential biosimilar, referencing Lucentis. We remain optimistic about the prospect of launching Aducanumab as the first therapy to meaningfully change the course of Alzheimer's disease, and this will be an important short-term and long-term growth driver for the company. In addition to Aducanumab, we believe our pipeline could enable a second wave of growth, in the mid-2020s driven by areas such as ophthalmology, stroke, lupus, and ALS. Importantly, we expect six mid- to late-stage data readouts by the end of 2021. We plan to continue pursuing external business development opportunities to further expand our pipeline. In just under four years, we have committed nearly $5 billion to business development and executed 20 transactions. Going forward, we will continue to prioritize the stability of our organization to support our current portfolio while preparing for the potential introduction of a number of new products, starting with Aducanumab. will be focused on diligent execution, capturing every opportunity for efficiency and cost savings. In summary, we have continued to execute well on our strategy. We believe we are well positioned to serve our current and future patients as we build a multi-franchise portfolio, leveraging the interconnectivity of our deep neuroscience pipeline. We have a very strong balance sheet and we will remain focused on maximizing long-term shoulder value creation. I will now turn the call over to Al for a more detailed update on our recent progress in R&D.