CEO Letter

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.

In 2020, we continued to carry out our Biogen FORWARD strategy that we have been building upon for the past four years. This strategy aims to leverage science and research to execute on our core business today while also developing and expanding our neuroscience portfolio to deliver for tomorrow. In doing so, we give hope to millions of patients as well as their loved ones and their caregivers, while positioning the company for what we believe will be a transformative 2021.

We now have 10 programs either in Phase 3 or filed with regulatory agencies, including in Alzheimer’s disease, neuropsychiatry, amyotrophic lateral sclerosis (ALS) and ophthalmology. In 2020, we added or advanced 12 clinical programs, bolstering our early- and late-stage pipelines through both internal development and collaborations with leading neuroscience companies, including Sangamo Therapeutics, Inc. (Sangamo), Denali Therapeutics Inc. (Denali) and Sage Therapeutics, Inc. (Sage). We believe we are well positioned for future growth with readouts expected in 2021 from eight clinical programs, of which four are pivotal readouts.

One of the most promising and near-term of these investigational therapies is aducanumab, which we are developing in collaboration with Eisai Co., Ltd. (Eisai). We completed regulatory filings of aducanumab in multiple geographies during 2020, and we remain ready to launch should our application be approved by the U.S. Food and Drug Administration (FDA). If approved, aducanumab would be the first therapy to meaningfully change the course of Alzheimer’s disease.

We are focused on advancing our broader purpose as an organization, as we aim to pioneer science for the betterment of humanity. We strive to be leaders by taking meaningful action for the patients we serve, our employees, the environment and the community – including accelerating our efforts in diversity, equity and inclusion. We believe that taken together, all of these steps contribute to sustainable, long-term stockholder value.

Financial Performance

I am proud of the more than 9,000 members of the Biogen team for their dedicated focus on day-to-day execution in order to serve all of our stakeholders. Despite the uncertainties and hardship caused by the COVID-19 pandemic for our society and our industry, full-year GAAP diluted earnings per share were $24.80 and Non-GAAP diluted earnings per share were $33.70. We generated $13.4 billion in revenue, representing a 6% decrease versus the prior year. This decline was largely due to an erosion in U.S. TECFIDERA revenue.

We achieved multiple sclerosis (MS) product revenue in the U.S. of $2.86 billion through June 30, 2020, the period before multiple, deeply discounted TECFIDERA generics entered the U.S. market. During the second half of 2020, MS product revenue in the U.S. was $2.25 billion.

During 2020, Biogen generated approximately $4.2 billion in net cash flow from operations and $3.8 billion in free cash flow. This cash flow generation continued to provide us with significant flexibility to allocate capital with the goal to maximize returns for our stockholders. As part of our capital allocation strategy, we also returned approximately $6.7 billion to stockholders through share repurchases during the year.

We executed eight business development deals for a total value of approximately $3 billion in 2020 and ended the year with $3.4 billion in cash, cash equivalents and marketable securities.

We will continue to allocate capital efficiently, effectively and appropriately. As we have demonstrated in the past, we will always strive to have an optimal capital structure as well as aim for superior returns from the investments we make.

 

Delivering on Our Core Business

Very few therapeutic areas have as much need or hold as much promise for medical breakthroughs as neuroscience. Our work over the years has centered on pursuing therapies that meaningfully slow or halt the progression of neurological and neurodegenerative diseases. That focus has resulted in our leadership in MS and spinal muscular atrophy (SMA).

While new entrants in these areas have pressured our market position, we have repeatedly demonstrated resilience with strong execution and a commitment to advancing treatment options for patients.

In addition, a key part of our Biogen FORWARD strategy is to unlock the potential of our biosimilars business. We believe biosimilars can lower healthcare system costs broadly, creating headroom for innovation. They can enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.  

BIOGEN FORWARD
Our approach to deliver sustainable value

Multiple Sclerosis

Globally, 2.8 million people suffer from MS. It is a progressive disease that causes damage to the central nervous system, resulting in physical disability as well as neurological dysfunctions involving movement, vision and cognition.

For nearly 25 years, we have led in the research and development of new therapies to treat this disease, and we remain focused on developing next-generation treatments. Our portfolio of 5 MS disease-modifying therapies has helped improve the lives of more than 1 million patients worldwide, and we have more than 25 active clinical trials.

Our entire MS portfolio, including royalties from OCREVUS®, generated $8.7 billion in global revenue in 2020. We demonstrated our resilience through our continued dedication to providing efficacious therapies for patients and our strong execution, despite the entry of TECFIDERA generics that impacted our revenue beginning in the third quarter of 2020.

A critical part of our strategy as leaders in MS is, and will continue to be, investment in innovation to address continuing unmet need. In the first half of 2020, we filed for regulatory review of a subcutaneous formulation of TYSABRI in both the U.S. and the European Union (EU). This subcutaneous formulation was approved in the EU in March 2021 and offers a competitive, more convenient administration profile in the space for high-efficacy MS treatments. We also received approval in the U.S. and the EU for a new intramuscular administration for PLEGRIDY.

In addition, we continued to advance the potential use of extended interval dosing of TYSABRI. We presented new data demonstrating the reduced risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection, through the use of extended interval dosing compared to the currently approved dosing.

Biogen continued its U.S. launch of VUMERITY. By year end, despite challenges to bringing a new treatment to market during the pandemic, VUMERITY was the number two MS product and the number one MS oral in new prescriptions in the U.S.

 

Spinal Muscular Atrophy

SMA is a leading genetic cause of mortality in infants, affecting about 1 in every 11,000 babies born in the U.S. SMA has a devastating effect on voluntary muscle movement, leading inevitably to muscle atrophy. Tragically, without treatment, most infants with the most severe type of SMA die within two years. Children with other types of the disease experience lasting mobility and quality of life issues throughout their teen and adult lives.

SPINRAZA (nusinersen) generated full-year global revenues of $2.1 billion in 2020. Outside of the U.S., full-year revenue increased 9% versus the prior year with continued growth in sales volumes. Biogen ended 2020 with roughly 11,000 patients on SPINRAZA, including through our clinical studies and expanded access program.

In the face of increasing competition in the SMA market, we believe that the proven efficacy and well-established safety profile of SPINRAZA makes it a foundation of care for patients.

We continued to generate additional data in 2020, including from NURTURE, which is the longest-running study in the industry examining pre-symptomatic patients with SMA. The data showed that patients being treated with SPINRAZA continued to maintain and make progressive gains in motor function compared to the natural course of the disease.

We continue to advance research in the field, exploring how SPINRAZA could create better outcomes for patients that still have unmet need – including after being treated with other therapies on the market. During the year, we started DEVOTE, a Phase 2/3 study to determine whether a higher dose of nusinersen could provide even greater efficacy. We also began RESPOND, a Phase 4 study evaluating the benefit of nusinersen in patients treated with the gene therapy Zolgensma® who display a suboptimal clinical response to Zolgensma.

 

Biosimilars

Our biosimilars business grew in both revenue and the number of patients on therapy through year end. The business generated $796 million in full-year revenue, with approximately 240,000 patients relying on our leading portfolio of anti-TNF biosimilars. And through the end of 2020, we have now shipped more than 19 million doses to patients in 30 European countries.

Our product differentiation, ongoing commitment to leading science and customer focus enabled our biosimilars business to generate an estimated savings of approximately €2.4 billion for healthcare systems across Europe in 2020.

We believe that the foundation of our biosimilars business is robust and that there is more growth opportunity possible through commercializing additional biosimilar products.

We notably made progress in ophthalmology, where we have commercialization rights for two potential biosimilar products from Samsung Bioepis Co., Ltd. (Samsung Bioepis):

  • SB11, a proposed ranibizumab biosimilar referencing LUCENTIS®
  • SB15, a proposed aflibercept biosimilar referencing EYLEA®

SB11 is under regulatory review in the U.S. and in the EU. In June 2020, a Phase 3 study was initiated to compare SB15 and the reference product (EYLEA). Global sales of both reference products were more than $11 billion 1 in 2020.

 

The Promise of Our Pipeline

We pride ourselves on not being afraid to go where others will not in order to achieve our mission to pioneer in neuroscience in order to transform lives. We know that the opportunity to address the unmet need is tremendous, and our determination has allowed us to advance breakthrough science.

In 2020, we made significant strides in diversifying and building a multi-franchise portfolio, propelled by our internal research efforts and by a number of licensing deals and collaborations. We now have 33 clinical programs, many of which were added in the last three years. We believe our pipeline represents one of our most significant value-creation opportunities, spanning a matrix of disease areas and modalities.

 

BUILDING A MULTI-FRANCHISE PORTFOLIO IN AREAS OF HIGH UNMET NEED

Alzheimer’s Disease

Worldwide approximately 50 million people suffer from Alzheimer’s disease or dementia, presenting a significant burden on patients, caregivers and society at large. Alzheimer's disease remains one of the top-10 causes of death in the U.S., affecting about 1 in 10 people over the age of 65. Projections suggest that, over the next 30 years, the number of people living with Alzheimer’s disease will triple.

With such a grim reality facing Alzheimer’s disease patients, Biogen has developed a pipeline of potential therapeutics that could slow disease progression. Aducanumab is our most advanced investigational asset. Preparing and filing the complex data packages supporting potential regulatory approval of aducanumab in the U.S., the EU and Japan were among our proudest moments in 2020.

We are committed to working with the FDA as it completes its review of our application, and we continue to stand behind our clinical data. We believe our results support approval; the Prescription Drug User Fee Act (PDUFA) action date for aducanumab is expected on June 7, 2021.

In preparation for the potential launch, we have continued to evaluate a wide spectrum of system readiness factors. We believe there are several hundred sites in the U.S. that are ready to start treating patients with aducanumab, if approved.

Another key component of our Alzheimer’s franchise is BAN2401, which is an anti-amyloid beta antibody also being developed in collaboration with Eisai. BAN2401 is currently in the pivotal Phase 3 Clarity AD study examining patients with symptomatic early Alzheimer’s disease. In 2020, the AHEAD 3-45 Study of BAN2401 was initiated to focus on individuals with preclinical Alzheimer’s disease who have intermediate or elevated levels of amyloid in their brains. This study is evaluating whether early administration of BAN2401 can potentially prevent cognitive decline in the earliest stages of the disease.

We are encouraged by our new global collaboration with Sangamo that leverages its zinc finger protein technology to modulate the expression of key genes involved in neurological diseases. Our aim is to develop gene regulation therapies for Alzheimer’s disease and more.

We also made progress on a number of other molecules in our early clinical and preclinical Alzheimer’s disease and dementia portfolio. Notably, we announced positive Phase 1 data for BIIB080 (anti-tau ASO), which may reduce production of the tau protein and its accumulation in brain cells, and which we believe may have the potential to slow the progress of Alzheimer's disease.

At the start of 2021, we announced a collaboration with Apple with the aim to develop digital biomarkers for cognitive health. A new virtual research study that we expect to begin during the second half of 2021 will leverage the technology of the Apple Watch and iPhone to develop digital biomarkers that could help a person monitor their cognitive health and screen for early stages of cognitive decline, including mild cognitive impairment.

Neuropsychiatry

In 2020, we entered into a collaboration with Sage that brought us a late-stage asset in depression that could address a significant unmet need. In the U.S. alone, 17 million people suffer from depression. Depression also is a common co-morbidity of multiple neurological disorders in our therapeutic portfolio. Despite its common occurrence, 50% of patients with major depressive disorder experience no relief from existing medications.

Through our collaboration with Sage, we will jointly develop and commercialize zuranolone (BIIB125) for the potential treatment of major depressive disorder and postpartum depression. Zuranolone is being evaluated as a potential first-in-class, two-week, once-daily oral therapy currently in multiple Phase 3 studies. Zuranolone may also have potential in other psychiatric disorders including treatment-resistant depression, bipolar depression and generalized anxiety disorder.

ALS

ALS is a fatal, progressive neurodegenerative disease with significant unmet medical need. People with ALS may experience a gradual weakening of muscles, causing them to lose their strength and ability to speak, move and eventually breathe. To date, no treatment has offered patients an option to fully mitigate the inevitable and devastating effects of this disease.

Leading our ALS portfolio is tofersen (BIIB067), which is currently being investigated in the Phase 3 VALOR study of SOD1 ALS, a subtype of familial ALS. In 2020, we also dosed our first patient in the Phase 1 study of BIIB105 (ataxin-2 ASO) 2, which has the potential to slow disease progression for the broad ALS population.

Lupus

Systemic lupus erythematosus (SLE) is an autoimmune disease that affects multiple organ systems and is unpredictable in disease severity, with periods of illness or flares alternating with periods of remission. A hallmark of SLE is the production of autoantibodies to a variety of nuclear antigens that account for some of the pathological manifestations and ultimately, organ damage.

In August 2020, the first patient was dosed in the Phase 3 PHOENYCS GO study of dapirolizumab pegol (anti-CD40L). This study, developed in collaboration with UCB Pharma S.A., targets patients with active SLE despite being treated by standard of care therapies. We also presented positive results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059 (anti-BDCA2) in individuals with lupus.

Ophthalmology

Adding to our work with investigational ophthalmological biosimilars, we are investigating the use of gene therapies to combat inherited retinal diseases. This includes BIIB111 (timrepigene emparvovec) for choroideremia, a condition of progressive vision loss, and BIIB112 (cotoretigene toliparvovec) for another vision loss disorder known as X-linked retinitis pigmentosa. Currently, neither disease has an approved treatment, and both lead to progressive vision loss and potential blindness by mid-life.

Parkinson’s Disease and Movement Disorders

Parkinson’s disease, the second-most common among neurodegenerative illnesses, is a progressive disorder of the central nervous system that causes nerve cell damage associated with tremors, stiffness and difficulty with balance and coordination.

Despite having discontinued BIIB054 (cinpanemab) following unsuccessful Phase 2 results, Biogen remains committed to advancing treatments for movement disorders. We believe two collaborations position us to lead in addressing these disorders. First, we are working with Denali to co-develop and co-commercialize BIIB122 (DNL151), a small molecule inhibitor of leucine-rich repeat kinase (LRRK2) for Parkinson’s disease. Second, we entered into a collaboration with Sage for joint development and commercialization of BIIB124 (SAGE-324), a Phase 2 asset for essential tremor with potential in other neurological conditions such as epilepsy.

 

Environment, Social and Governance Leadership

We are working to change lives not just through our science, but through our actions on climate and health as well as diversity, equity and inclusion. Our longstanding leadership in corporate responsibility is built upon transparent and clear disclosure of our policies and performance across environmental, social and governance (ESG) issues. As part of our commitment to these critical issues, we have tied a portion of our employees' and executive officers’ 2021 compensation to advancing our ESG strategy.

The COVID-19 pandemic has provided a clear reminder of just how interrelated health, climate and equity are, and events throughout the year highlighted dramatic disparities that exist on each of these fronts. We took further action in 2020 that underscores our belief that the most successful corporations are those that consider a broad array of stakeholder needs in operating their businesses. We embarked on ambitious goals to augment diversity among our leadership. We also initiated a program to eliminate fossil fuels across our footprint – something we believe will help us realize long-term operational savings.

In addition, we continued to build on our priorities for health equity and access, collaborating with a range of stakeholders to promote this shared goal. For example, SPINRAZA is approved in more than 50 countries, including low- and middle-income countries, and our policy to promote access for SPINRAZA will help inform our approach to our broader portfolio of therapies.

We have long been recognized for our corporate responsibility leadership. In 2020, we were named the #1 biotechnology company on the Dow Jones Sustainability World Index – for an industry-record fifth time. Our corporate responsibility reporting meets multiple guidelines set by organizations at the forefront of ESG disclosures. We are proud of these achievements, but we know there is more to be done. We encourage you to read our Year in Review: Our Commitment to Corporate Responsibility report for more detail.

 

Climate, Health and Equity

The paradox of the pharma and biotech industries is that we cannot truly lead in human health without mitigating our operational impact on the environment. We believe it is imperative for Biogen to make the fight against climate change part of our long-term strategy and investment in our future.

In September 2020, we launched Healthy Climate, Healthy Lives, a $250 million, 20-year initiative to eliminate fossil fuels across our operations by 2040 and improve public health. We are the first Fortune 500 company to make such a bold commitment, which goes far beyond net zero. Collaborations related to this effort, including with MIT and the Harvard T.H. Chan School of Public Health, aim to advance the science around how fossil fuel-related air pollution may impact brain health, and will help under-resourced healthcare centers prepare for climate risks and improve health outcomes for the vulnerable populations they serve.

Diversity, Equity & Inclusion

We believe that diversity drives innovation and that different backgrounds, cultures and perspectives make us stronger as an organization. Biogen took actions in 2020 to further reinforce our view that prejudice, racism and intolerance are unacceptable.

After holding several listening sessions throughout the organization, we introduced an enhanced Diversity, Equity & Inclusion (DE&I) strategy that outlines actionable steps to deepen our commitment from an already strong foundation.

We aim to increase diversity 3 in U.S. manager positions and above by 30% by the end of 2021 – and, globally, to increase women in director-and-higher positions by the same percentage and in the same timeframe.

To transparently report our progress, we have publicly disclosed our EEO-1 (Equal Employment Opportunity) data on our website and shared the results of a global pay equity analysis with our employees.

We are intent on improving health outcomes for underserved and underrepresented patients. We presented research at MSVirtual2020, the eighth joint meeting of ACTRIMS-ECTRIMS, that showed that ethnic and racial disparities exist related to occupation, income status, MS-related disability and type of treatment used. Furthermore, Biogen is committed to increasing the diversity of our clinical trials to improve minority representation over time. For example, we are collaborating with Tufts University, considering both study design and patient recruitment.

Finally, economic empowerment is a critical aspect of our work in addressing systemic racism and inequity. We deposited $10 million with OneUnited Bank, the largest Black-owned bank in America, to support its focus on Black economic empowerment. In addition, we are continuing our efforts to expand sourcing with minority-owned businesses.

ENHANCED DIVERSITY, EQUITY & INCLUSION STRATEGY

 

Looking Ahead

Undeniably, 2020 was a challenging year. But resilience matters, as does a commitment to execution. We are proud that we deepened our pipeline, broadened our global footprint and delivered strong operating results. We believe we are well positioned to build on our strong record of execution, going beyond our current core businesses in an acceleration of our multi-franchise portfolio strategy.

As we explore promising therapies that could benefit patients, we are expanding the definition of what is possible – while aiming to address significant unmet needs. I am looking forward to our many expected readouts on the horizon in 2021 as well as upcoming regulatory decisions.

We also aim to be at the forefront of neurotechnology. We anticipate that the rapid pace of innovation in digital health and data sciences can be harnessed to enhance our patient services and engagement. We believe this will allow us to have a more holistic approach to detecting and managing neurological diseases.

While we believe 2021 will be a reset year for the company financially, we also believe it has the potential to be transformative for Biogen. We are confident in our ability to meet the needs of patients who look to us for therapeutic options, to deliver results for our stockholders – and to expand the definition of what is possible in neuroscience.

We remain driven by a shared purpose in everything we do at Biogen: advancing science for the benefit of humanity. Together, we are undertaking a deeply human mission with profound implications for the millions of people awaiting life-changing therapies. The vision is for a healthier, more sustainable and equitable world.

Biogen has been able to execute against this vision due to my extraordinary colleagues, the trust of our stockholders and deep relationships with our stakeholders. I am grateful to all who have been part of this journey.

If 2020 was a year that required resilience and courage, I believe that 2021 will be a year of transformation – one that has the potential to bring great hope to patients worldwide.

Michel Vounatsos
Chief Executive Officer

 

 

1Company reported sales, EvaluatePharma.
2Subject to an option agreement with Ionis Pharmaceuticals, Inc.
3Percent of U.S. manager positions and above held by Black, African American, and Latinx employees as well as Asian employees where underrepresented.