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2019 Annual Report

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2019 Annual Report 2019 ANNUAL REPORT Biogen 2019 Annual Report PERFORMANCE HIGHLIGHTS Total Revenues Product Revenues ($ in millions) ($ in millions and % of total product revenues) 2019 $14,378 2019 2018 TECFIDERA 2018 $13,453 SPINRAZA $2,097 $1,724 $4,433 $4,274 18.4% 15.8% 38.95% 39.3% 2017 $12,274 TYSABRI VUMERITY5 2016 $11,449 $1,892 $1,864 $6 – 16.6% 17.1% 0.05% – 2015 $10,764 Other4 Interferon6 $851 $662 $2,102 $2,363 GAAP Diluted EPS/Non-GAAP Diluted EPS 1 7.5% 6.1% 18.5% 21.7% 2019 $31.42 $33.57 2018 $21.58 $26.20 2017 $11.92 $21.81 Product Revenues by Region (% of total product revenues) U.S. Rest of the world 2016 $16.93 $20.22 2015 $15.34 $17.01 2019 2018 2017 Free Cash Flow 1,3 41% 37% 32% ($ in millions) 59% 63% 68% 2019 $6,264 2018 $3,917 2017 $2,484 2016 $2,706 2015 $2,223 +4.5% increase in total product revenues year over year 1 Non-GAAP diluted earnings per share (EPS) and Free Cash Flow are Non-GAAP financialmeasures. A reconciliation of GAAP to Non-GAAP diluted EPS and Free Cash Flow amounts is set forth on pages 9–13 of this Annual Report. 2 GAAP diluted EPS for 2018 and 2017 includes charges of $125 million and $1,176 million, respectively, related to the impact of the Tax Cuts and Jobs Act of 2017. 100% 46% 3 Free Cash Flow for 2016 through 2019 reflects an increase in capital expenditures related to the construction of our large-scale biologics manufacturing facility in total renewal of manager-level Concept, design and realization Solothurn, Switzerland. electricity purchased and above positions PETRANIX Corporate and Financial Communications AG 4 For 2019 and 2018 Other includes product revenues from FAMPYRA, FUMADERM, by Biogen held by women Adliswil, Zurich – Switzerland BENEPALI, FLIXABI and IMRALDI. For 2018 Other also includes product revenues from www.petranix.com ZINBRYTA, which was voluntary withdrawn from the market in March 2018. 5 VUMERITY was approved by the U.S. Food and Drug Administration in October 2019 and became available in the U.S. in November 2019. Printing 6 Interferon includes AVONEX and PLEGRIDY. Donnelley Financial Solutions, dfinsolutions.com Biogen 2019 Annual Report 1 CEO LETTER My fellow stockholders, 2019 was a remarkable year for Biogen as we delivered strong operating performance across all of our core business areas, double-digit earnings growth versus a year ago and strong execution of our strategy. We strengthened our pipeline by adding seven new clinical programs, which we believe will help us further expand our multi-franchise portfolio and drive mid- and long-term growth. 2019 was also marked by changing developments for aducanumab, an investigational treatment for early Alzheimer’s disease. In October 2019, together with our collaboration partner Eisai Co., Ltd. (Eisai), we announced plans to pursue regulato- ry approval for aducanumab in the U.S. This decision was based on a new analysis, conducted in consul- tation with the U.S. Food and Drug Administration (FDA), of a larger dataset from the Phase 3 EMERGE "We work with purpose to advance and ENGAGE studies of aducanumab that had science to address the urgent and been discontinued in March 2019 following a pre-specified futility analysis. long-term challenges facing humanity." Michel Vounatsos, Chief Executive Officer The extraordinary events surrounding aducanumab and the progress across our portfolio is a testa - ment to Biogen’s commitment to follow the science – one that was made possible by fearless, dedicat- Our purpose ed colleagues. At Biogen we pioneer science with the goal of better understanding and preserving the underlying Before turning to 2019 in more detail, we want to qualities of our essential human nature. We strongly acknowledge the health and economic challenges believe that neuroscience is the next frontier that facing all of us as a result of the current COVID-19 will see real scientific progress and breakthrough, pandemic. Many of our communities as well as and we believe that our diverse, talented workforce, a number of our colleagues have been directly with more than 7,700 employees worldwide, is affected by COVID-19. We are committed to doing uniquely positioned to take on some of the most all we can to ensure the health and safety of all our challenging healthcare needs and to move Biogen employees and to provide an uninterrupted supply forward. As we work to improve patients’ lives, we of our medicines to patients around the world. We also care deeply about making a difference in our are grateful to everyone at Biogen who has helped society as a whole through science that may have us maintain our manufacturing and business the potential to, among other things, improve brain operations so that patients can continue to receive health, mobility and vision. We focus on science that our therapies. We are closely monitoring the ongoing seeks to solve societal problems and create access and ever-changing developments and the impact it to innovation. We work with purpose to advance may have on our business operations, including our science to address the urgent and long-term sales, manufacturing and clinical trials. challenges facing humanity. 2 Biogen 2019 Annual Report CEO LETTER Delivering sustainable performance for example, the advancements that followed the In 2019 we generated $14.4 billion in full-year total discoveries of anesthesia, medical imaging, penicil- revenues, a 7% increase versus the prior year, and lin, organ transplants, HIV treatment and immuno- we generated net cash flows from operations of therapy. For Biogen, we believe our expertise and approximately $7.1 billion. GAAP diluted earnings capabilities could lead to the next major inflection per share for 2019 were $31.42, an increase of point in neuroscience. 46% over 2018, and Non-GAAP diluted earnings per share increased 28% over the prior year to $33.57. Our view is that neurological diseases are deeply con- nected. As the pathways of disease are interrelated, Our business and cash generation remained strong so are the potential approaches to treating them. Our and provided us with the flexibility to allocate capital experience in MS gives our scientists and researchers to create long-term stockholder value. In 2019 deeper insights into remyelination and repair, neuro- we spent approximately $2.3 billion in research protection and axonal health, with potential appli- and development and repurchased approximately cations in Alzheimer’s disease, Parkinson disease, 24 million shares of our common stock for a total amyotrophic lateral sclerosis (ALS) and stroke. value of approximately $5.9 billion. In addition, we spent approximately $515 million in 2019 on Leading in Alzheimer’s disease capital expenditures, including a significant The announcement in October 2019 of our plan to investment in the large scale biologics pursue regulatory filing for aducanumab in the U.S. manufacturing facility we are building in was one of the highlights of our year. 2019 Solothurn, Switzerland. total revenues In March 2019 we announced the discontinuation These results reflect the resilience of our of EMERGE and ENGAGE, our two Phase 3 studies, +7% multiple sclerosis (MS) business as based on the results of a pre-specified futility anal- well as the continued growth of both ysis that predicted that both studies were unlikely SPINRAZA and our biosimilars business. to meet their primary endpoint upon completion. In retrospect, we now know that the result of the futility Capturing the neuroscience opportunity analysis, based on a smaller and earlier dataset, To review Biogen’s strong 2019 performance – was incorrect. Following the discontinuation of the as well as Biogen’s future – let’s consider some studies, additional data from a greater number of key statistics. patients became available. It is estimated that approximately 50 million people A new analysis of this larger dataset, conducted in worldwide suffer from dementia and approximately consultation with the FDA, showed that the Phase 10 million suffer from Parkinson’s disease. 3 EMERGE study met its pre-specified primary and Neurological disease is the leading cause of disability secondary endpoints by showing a significant reduc- and the second largest cause of death globally. 1,2 tion in clinical decline. And, we believe that results from a subset of patients in the Phase 3 ENGAGE Aging populations will almost certainly increase these study who received sufficient exposure to high dose numbers significantly. It is estimated that the global aducanumab support the findings from EMERGE, population over the age of 60 will be nearly 1.5 billion though ENGAGE did not meet its primary endpoint. by 2030, and by 2050 those over 60 will be nearly 2 billion, with 1.5 billion over the age of 65. 3,4 Over the past months, we have been actively engaging with the FDA and are working diligently to These numbers are only part of the story. There complete the regulatory filing in the U.S. as soon are important inflection points in medical history as possible. We are also actively engaging with when a breakthrough in knowledge or technology regulators in Europe and in Japan based on the generates new ideas and treatments. Consider, positive results of the new findings. Biogen 2019 Annual Report 3 BIOGEN FORWARD Our approach to deliver sustainable value Strong core business and investing for future growth EXECUTING CREATING ON THE CORE NEW SOURCE BUSINESS OF VALUE Maximizing the resilience Leading in of our MS core business Alzheimer's disease Accelerating Developing and expanding our neuroscience our neuromuscular franchise portfolio and pursuing therapeutic adjacencies Unlocking the Continuous improvement and potential of biosimilars diligent capital allocation One of our first priorities was to offer eligible We also believe it will take more than one therapy patients who had been enrolled in the discontinued to treat Alzheimer’s disease, so we continue to aducanumab studies the possibility of restarting the advance a broad portfolio of potential Alzheimer’s investigational treatment.
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