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Biogen Inc. 2020 Annual Report

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Biogen Inc. 2020 Annual Report Annual Report Biogen ANNUAL REPORT 2020 ® CONTAINS SOYOIL 2020 HIGHLIGHTS Total Revenue Product Revenue ($ in millions) ($ in millions and % of total product revenue) 2020 $13,445 $3,905 36.5% Fumarate 5 2020 $13,445 $4,438 39.0% 2019 $14,378 $1,878 17.6% 2019 $14,378 Interferon 6 2018 $13,453 $2,102 18.5% 2018 $1,946 18.2% 2017 $12,274$13,453 TYSABRI 2017 $12,274 $1,892 16.6% 2017 2016 $11,449$12,274 $2,052 19.2% 2016 $11,449 SPINRAZA 2016 $11,449 $2,097 18.4% $911 8.5% Other 7 GAAP Diluted EPS ⁄ Non-GAAP Diluted EPS 1 $851 7.5% 2020 $24.80 ∕ $33.70 2 2020 2020 $24.80 ∕ $33.70 2 2019 $31.42 ∕ $33.57 2019 2019 $31.42 ∕ $33.57 2018 $21.58 3 ∕ $27.44 2 2018 $21.58 3 ∕ $27.44 2 2017 $11.92 3 ∕ $22.72 2 2017 $11.92 3 ∕ $22.72 2 2016 $16.93 ∕ $20.22 2016 $16.93 ∕ $20.22 Free cash flow1,4 Product Revenue by Region ($2020 in millions) $3,805 (% of total product revenue) 2020 $3,805 2019 $6,564 2020 2019 2018 2019 $6,564 2018 $5,417 2018 $5,417 % % % 2017 $3,684 55 59 63 2017 $3,684 % % % 2016 $3,906 45 41 37 2016 $3,906 U.S. Rest of the world 1 Non-GAAP diluted earnings per share (EPS) and free cash flow are Non-GAAP financial measures. A reconciliation of GAAP to FOSSIL 1st Fortune 500 company to Non-GAAP diluted EPS and free cash flow amounts is set forth on FUEL FREE commit to going fossil fuel free pages 10–13 of this Annual Report. across operations by 2040 2 Beginning in the third quarter of 2020, material upfront BY 2040 payments associated with significant collaboration and licensing arrangements are excluded from Non-GAAP R&D expense in order Biotech leader on the Dow Jones to better reflect the Company's core operating performance. Prior Nº1 Sustainability World Index for 5th time period Non-GAAP results have been updated to reflect this change. 3 GAAP diluted EPS for 2018 and 2017 includes charges of Granted by the Biogen Foundation to $125 million and $1,174 million, respectively, related to the $ COVID-19 relief efforts, assisting impact of the Tax Cuts and Jobs Act of 2017. 12 4 Beginning in 2020, free cash flow was redefined as net cash flow MILLION 82 organizations across 35 countries from operations less capital expenditure. Prior period free cash Concept, design and realization flow amounts have been updated to reflect this change. Free Students engaged in our STEM PETRANIX AG cash flow for 2016 through 2019 reflects an increase in capital Community Labs since 2002 with expenditures related to the construction of our largescale biologics > Corporate and Financial Communications 57K focus on underrepresented students manufacturing facility in Solothurn, Switzerland. www.petranix.com 5 Fumarate includes TECFIDERA and VUMERITY. VUMERITY became commercially available in the U.S. in November 2019. Score as Corporate Equality Printing th 6 Interferon includes AVONEX and PLEGRIDY. Index for the 8 time: Best Places Donnelley Financial Solutions 7 For 2020 and 2019, Other includes product revenue from 100 % to Work for LGBTQ Equality FAMPYRA, FUMADERM, BENEPALI, FLIXABI and IMRALDI. www.dfinsolutions.com CEO LETTER 1 CEO LETTER My fellow stockholders, 2020 was a year like no other. The COVID-19 pandemic stole millions of lives while throwing many others into economic hardship. Disasters escalated the urgency of our global climate crisis. And events throughout the year intensified the need for action in addressing persistent racial injustice within our communities. The impact of all of these will be with us for a long time. At Biogen, these unprecedented challenges have strengthened our purpose to address science for the betterment of humanity. We found the resilience to deliver a strong operating performance and maintain global leadership across our core businesses. My dedicated colleagues, rather than being overcome by hardship and everyday challenges, continued to advance our pipeline and our strategy to build a multi- franchise portfolio leveraging the interconnectivity within neuroscience. We are focused on advancing In 2020, we continued to carry out our Biogen FORWARD strategy that we have been building our broader purpose as an upon for the past four years. This strategy aims to organization, as we aim leverage science and research to execute on our core business today while also developing and to pioneer science for the expanding our neuroscience portfolio to deliver betterment of humanity.” for tomorrow. In doing so, we give hope to millions Michel Vounatsos of patients as well as their loved ones and their CHIEF EXECUTIVE OFFICER caregivers, while positioning the company for what we believe will be a transformative 2021. One of the most promising and near-term of We now have 10 programs either in Phase 3 or filed these investigational therapies is aducanumab, with regulatory agencies, including in Alzheimer’s which we are developing in collaboration with disease, neuropsychiatry, amyotrophic lateral Eisai Co., Ltd. (Eisai). We completed regulatory sclerosis (ALS) and ophthalmology. In 2020, we filings of aducanumab in multiple geographies during added or advanced 12 clinical programs, bolstering 2020, and we remain ready to launch should our our early- and late-stage pipelines through both application be approved by the U.S. Food and Drug internal development and collaborations with leading Administration (FDA). If approved, aducanumab neuroscience companies, including Sangamo would be the first therapy to meaningfully change Therapeutics, Inc. (Sangamo), Denali Therapeutics Inc. the course of Alzheimer’s disease. (Denali) and Sage Therapeutics, Inc. (Sage). We believe we are well positioned for future growth We are focused on advancing our broader purpose with readouts expected in 2021 from eight clinical as an organization, as we aim to pioneer science for programs, of which four are pivotal readouts. the betterment of humanity. We strive to be leaders BIOGEN 2020 ANNUAL REPORT 2 CEO LETTER business development deals for a 8 total value of approximately $3 billion by taking meaningful action for the patients we serve, Delivering on Our Core Business our employees, the environment and the community – Very few therapeutic areas have as much need including accelerating our efforts in diversity, equity or hold as much promise for medical breakthroughs and inclusion. We believe that taken together, all as neuroscience. Our work over the years has of these steps contribute to sustainable, long-term centered on pursuing therapies that meaningfully stockholder value. slow or halt the progression of neurological and neurodegenerative diseases. That focus has Financial Performance resulted in our leadership in MS and spinal muscular I am proud of the more than 9,000 members of the atrophy (SMA). Biogen team for their dedicated focus on day-to-day execution in order to serve all of our stakeholders. While new entrants in these areas have pressured our Despite the uncertainties and hardship caused by the market position, we have repeatedly demonstrated COVID-19 pandemic for our society and our industry, resilience with strong execution and a commitment to full-year GAAP diluted earnings per share were advancing treatment options for patients. $24.80 and Non-GAAP diluted earnings per share were $33.70. We generated $13.4 billion in revenue, In addition, a key part of our Biogen FORWARD representing a 6% decrease versus the prior year. strategy is to unlock the potential of our biosimilars This decline was largely due to an erosion in U.S. business. We believe biosimilars can lower TECFIDERA revenue. healthcare system costs broadly, creating headroom for innovation. They can enable governments to We achieved multiple sclerosis (MS) product revenue potentially redirect savings to priorities such as in the U.S. of $2.86 billion through June 30, 2020, increasing access to transformative therapies. the period before multiple, deeply discounted TECFIDERA generics entered the U.S. market. During Multiple Sclerosis the second half of 2020, MS product revenue in the Globally, 2.8 million people suffer from MS. It is a U.S. was $2.25 billion. progressive disease that causes damage to the central nervous system, resulting in physical During 2020, Biogen generated approximately disability as well as neurological dysfunctions $4.2 billion in net cash flow from operations and involving movement, vision and cognition. $3.8 billion in free cash flow. This cash flow generation continued to provide us with significant flexibility to For nearly 25 years, we have led in the research and allocate capital with the goal to maximize returns for development of new therapies to treat this disease, our stockholders. As part of our capital allocation and we remain focused on developing next-generation strategy, we also returned approximately $6.7 billion to treatments. Our portfolio of 5 MS disease-modifying stockholders through share repurchases during the year. therapies has helped improve the lives of more than 1 million patients worldwide, and we have more We executed eight business development deals for than 25 active clinical trials. a total value of approximately $3 billion in 2020 and ended the year with $3.4 billion in cash, cash Our entire MS portfolio, including royalties from equivalents and marketable securities. OCREVUS®, generated $8.7 billion in global revenue in 2020. We demonstrated our resilience We will continue to allocate capital efficiently, through our continued dedication to providing effectively and appropriately. As we have efficacious therapies for patients and our strong demonstrated in the past, we will always strive to execution, despite the entry of TECFIDERA generics have an optimal capital structure as well as aim for that impacted our revenue beginning in the third superior returns from the investments we make.
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