On this page of StockholderLetter.com we present the 4/28/2023 shareholder letter from BIOGEN INC. — ticker symbol BIIB. Reading current and past BIIB letters to shareholders can bring important insights into the investment thesis.
ANNUAL REPORT 2022
Safe harbor This letter contains forward-looking statements relating to: our strategy and plans; potential of, and expectations for, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings and approvals; the potential benefits, safety, and efficacy of our and our collaboration partners products and investigational therapies; the anticipated benefits and potential of investments, cost-saving initiatives, actions to improve risk profile and productivity of R&D pipeline, collaborations and business development activities; and our future financial and operating results. These forward-looking statements may be accompanied by such words as aim, anticipate, believe, could, estimate, expect, forecast, goal, intend, may, plan, potential, possible, prospect, will, would, and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later-stage or larger-scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively due to significant product competition in the markets for our products; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing and reimbursement for our products; our dependence on collaborators, joint venture partners and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; the potential impact of the conflict in Ukraine; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; failure to obtain, protect and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early-stage clinical trials may not be predictive of results in later-stage or large-scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, the risk that regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use of our products, or product liability claims; risks relating to technology failures or breaches; problems with our manufacturing processes; risks relating to management and personnel changes, including attracting and retaining personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to investment in our manufacturing capacity; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media for our business; results of operations and financial condition; fluctuations in our operating results; risks related to investment in properties; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; risks relating to access to capital and credit markets; risks related to indebtedness; change in control provisions in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this letter. We do not undertake any obligation to publicly update any forward-looking statements.
CEO Letter For more than 40 years, Biogen has been driven by its heritage of innovation. As we write the next chapter in our story, I see substantial opportunity to build on that strong legacy as we execute on clear priorities to put the company back on a sustainable growth trajectory. Christopher A. Viehbacher President and Chief Executive Officer My fellow stockholders, I am honored to write you as Biogen s new President and Chief Executive Officer and to have joined a team that is pioneering important new medicines to address some of the most difficult and challenging conditions in healthcare. For more than 40 years, Biogen has been driven by its heritage of innovation. As we write the next chapter in our story, I see substantial opportunity to build on that strong legacy as we execute on clear priorities to put the company back on a sustainable growth trajectory. In 2022, Biogen continued to advance therapeutic breakthroughs for patients and achieved financial performance in line with expectations, while adversely affected by increased competition in our multiple sclerosis (MS) portfolio. I step into this role with the clear understanding that we are operating in a much more competitive environment, with a cost base higher than industry benchmarks, and therefore need to transform the business to build an even stronger company for the benefit of patients, investors and other stakeholders. We are starting that journey with some clear advantages, including being in the remarkable position of having developed two potentially transformative medicines that we believe would give us significant potential future opportunity. The first would treat Alzheimer s disease (AD), and a second, pending U.S. Food and Drug Administration (FDA) approval, would treat depression in a new way. In 2023, we are focused on executing on these and other opportunities, while also reducing our cost base, as we build on our 2022 results. We maintained a strong financial position last year, giving us the opportunity to invest prudently in our business. We generated more than $10.1 billion in revenue, while reducing overall expenses through our cost reduction measures. We ended the year with approximately $5.6 billion in total cash, cash equivalents and marketable securities. Allocating that capital will be a primary focus for Biogen in 2023 as we look to rationalize our cost base and achieve a meaningful return on investment where we do invest. I would like to thank you for your continued support of and investment in Biogen. I outline below how in 2023 we intend to execute against several priorities. Bringing two breakthrough medicines to market In January 2023, the FDA granted accelerated approval to LEQEMBI (lecanemab-irmb), a treatment for early AD developed in collaboration with Eisai Co., Ltd (Eisai). The accelerated approval was based on phase 2 data that demonstrated LEQEMBI reduced the accumulation of amyloid-beta (A ) plaque in the brain, a defining feature of AD. The data from the phase 3 CLARITY AD study provide clear evidence that reducing plaque burden slows cognitive decline. After decades of research, we can now see the promise of potential disease modification. With potential traditional approval the Prescription Drug User Fee Act (PDUFA) date is planned for July 6, 2023 broader access could be within reach of more patients. The Centers for Medicare Biogen Annual Report 2022 1
CEO Letter & Medicaid Services (CMS) announced its intent to provide broader coverage on the same day within the Coverage with Evidence Development framework. We believe LEQEMBI represents a catalyst for further innovation and is an incredible opportunity to build upon as we invest in advancing the care of patients suffering with AD. We continue to see progress in the development of blood-based and digital biomarkers. We imagine a world where early detection, before the onset of symptoms, will have the potential to allow treatment much earlier in the disease course to potentially delay or even prevent AD. Biogen is committed to continuing research in AD, including investigation into a promising molecule in our pipeline which could reduce tau, another defining pathology of AD. In collaboration with Sage Therapeutics Inc. (Sage), we have advanced zuranolone, a potential treatment for major depressive disorder (MDD) and postpartum depression (PPD). If approved, zuranolone could be an important new treatment option in an area with high unmet need. We have all seen the surge in mental illness the last few years, and we know the current standard-ofcare antidepressants may not work for everyone or may take up to six to eight weeks to reach maximal efficacy when they do. Zuranolone is currently under priority review at the FDA as a potential 14-day, rapid-acting, once-daily, oral medication to treat MDD and PPD following promising phase 3 clinical trial results. Its novel mechanism of action targets brain networks responsible for functions such as mood, arousal, behavior and cognition and could provide benefit as early as day three. With a PDUFA date set for August 5, 2023, we are anticipating a potential launch toward the end of the year in the United States, and we are building our commercial infrastructure and capabilities to enter this market. Strengthening our portfolio and our pipeline, and improving operational efficiency We believe our return to a sustainable growth trajectory will also require thoughtful portfolio and pipeline optimization, external growth initiatives and diligent cost management across the enterprise. In our core business, we are working to deliver on further growth opportunities in spinal muscular atrophy (SMA) and improving our profitability in MS. 2 We have started a review of our strategic options for our biosimilars business. Our research and development pipeline and balance sheet are strong, and we believe our pipeline will be able to deliver significant growth over the medium and long term. But there is still more we must do to optimize our existing portfolio and diversify into new therapeutic areas such as neuropsychiatry, specialized immunology and rare diseases. We are closely examining new paths to balancing and de-risking our pipeline in a systemic and data-driven way, while sharpening our focus on value generation in the areas in which we have the most confidence, as compared to the achievement of operational milestones alone. Through internal research and development, thoughtful business development, and disciplined capital allocation, I believe we will create new opportunities for growth. We also have the goal of bringing our cost base in line with our revenue expectations while, at the same time, investing in upcoming launches and potential future growth drivers. We remain on track to achieve our previously announced $1.0 billion in cost-saving initiatives, and we will continue to seek new ways to create shareholder value and achieve greater operational efficiency. Building on our heritage of innovation As we approach the 45th anniversary of Biogen, it is a privilege to lead such an established, purpose-driven and diverse organization. I was drawn to join Biogen not only for its reputation as a biotechnology pioneer, but also by its dynamic team, which is as committed to advancing health equity as it is to pioneering patient breakthroughs. I have had the pleasure of getting to know many talented employees over the past several months and have witnessed firsthand their incredible expertise, tenacity and passion for our mission. I look forward to executing against our key milestones in 2023, with the support of the accomplished team at Biogen, our strong partnerships with collaborators like Eisai and Sage, and the continued support of our shareholders. Sincerely, Christopher A. Viehbacher President and Chief Executive Officer Biogen Annual Report 2022
 • shareholder letter icon 4/28/2023 Letter Continued (Full PDF)
 • stockholder letter icon 4/26/2024 BIIB Stockholder Letter
 • stockholder letter icon 4/25/2025 BIIB Stockholder Letter
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 • Benford's Law Stocks icon BIIB Benford's Law Stock Score = 92


BIIB 4/28/2023 Shareholder/Stockholder Letter Transcript:

ANNUAL
REPORT
2022

Safe harbor
This letter contains forward-looking statements
relating to: our strategy and plans; potential of,
and expectations for, our commercial business and
pipeline programs; capital allocation and investment
strategy; clinical development programs, clinical trials,
and data readouts and presentations; regulatory
discussions, submissions, filings and approvals; the
potential benefits, safety, and efficacy of our and our
collaboration partners    products and investigational
therapies; the anticipated benefits and potential
of investments, cost-saving initiatives, actions to
improve risk profile and productivity of R&D pipeline,
collaborations and business development activities;
and our future financial and operating results. These
forward-looking statements may be accompanied by
such words as    aim,       anticipate,       believe,       could,   
   estimate,       expect,       forecast,       goal,       intend,   
   may,       plan,       potential,       possible,       prospect,   
   will,       would,    and other words and terms of similar
meaning. Drug development and commercialization
involve a high degree of risk, and only a small number
of research and development programs result in
commercialization of a product. Results in early-stage
clinical trials may not be indicative of full results or
results from later-stage or larger-scale clinical trials
and do not ensure regulatory approval. You should not
place undue reliance on these statements.
These statements involve risks and uncertainties that
could cause actual results to differ materially from
those reflected in such statements, including: our
dependence on sales from our products; uncertainty
of long-term success in developing, licensing, or
acquiring other product candidates or additional
indications for existing products; failure to compete
effectively due to significant product competition in
the markets for our products; failure to successfully
execute or realize the anticipated benefits of our
strategic and growth initiatives; difficulties in obtaining
and maintaining adequate coverage, pricing and
reimbursement for our products; our dependence on
collaborators, joint venture partners and other third
parties for the development, regulatory approval, and
commercialization of products and other aspects of
our business, which are outside of our full control;
the potential impact of the conflict in Ukraine; risks
associated with current and potential future healthcare
reforms; risks related to commercialization of
biosimilars; failure to obtain, protect and enforce our
data, intellectual property, and other proprietary rights
and the risks and uncertainties relating to intellectual
property claims and challenges; the risk that positive
results in a clinical trial may not be replicated in
subsequent or confirmatory trials or success in
early-stage clinical trials may not be predictive of
results in later-stage or large-scale clinical trials or
trials in other potential indications; risks associated
with clinical trials, including our ability to adequately
manage clinical activities, unexpected concerns that
may arise from additional data or analysis obtained
during clinical trials, the risk that regulatory authorities
may require additional information or further studies,
or may fail to approve or may delay approval of our
drug candidates; the occurrence of adverse safety
events, restrictions on use of our products, or product
liability claims; risks relating to technology failures or
breaches; problems with our manufacturing processes;
risks relating to management and personnel changes,
including attracting and retaining personnel; failure
to comply with legal and regulatory requirements;
the risks of doing business internationally, including
currency exchange rate fluctuations; risks relating
to investment in our manufacturing capacity; the
direct and indirect impacts of the ongoing COVID-19
pandemic on our business; risks relating to the
distribution and sale by third parties of counterfeit or
unfit versions of our products; risks relating to the use
of social media for our business; results of operations
and financial condition; fluctuations in our operating
results; risks related to investment in properties; the
market, interest, and credit risks associated with our
investment portfolio; risks relating to share repurchase
programs; risks relating to access to capital and
credit markets; risks related to indebtedness; change
in control provisions in certain of our collaboration
agreements; fluctuations in our effective tax rate;
environmental risks; and any other risks and
uncertainties that are described in other reports we
have filed with the U.S. Securities and Exchange
Commission. These statements speak only as of the
date of this letter. We do not undertake any obligation
to publicly update any forward-looking statements.

CEO Letter
For more than 40 years, Biogen has been driven by its
heritage of innovation. As we write the next chapter in
our story, I see substantial opportunity to build on that
strong legacy as we execute on clear priorities to put
the company back on a sustainable growth trajectory.
Christopher A. Viehbacher
President and Chief Executive Officer

My fellow stockholders,
I am honored to write you as Biogen   s new President
and Chief Executive Officer and to have joined a
team that is pioneering important new medicines to
address some of the most difficult and challenging
conditions in healthcare. For more than 40 years,
Biogen has been driven by its heritage of innovation.
As we write the next chapter in our story, I see
substantial opportunity to build on that strong legacy
as we execute on clear priorities to put the company
back on a sustainable growth trajectory.
In 2022, Biogen continued to advance therapeutic
breakthroughs for patients and achieved financial
performance in line with expectations, while adversely
affected by increased competition in our multiple
sclerosis (MS) portfolio. I step into this role with the
clear understanding that we are operating in a much
more competitive environment, with a cost base
higher than industry benchmarks, and therefore need
to transform the business to build an even stronger
company for the benefit of patients, investors and
other stakeholders.
We are starting that journey with some clear
advantages, including being in the remarkable position
of having developed two potentially transformative
medicines that we believe would give us significant
potential future opportunity. The first would treat
Alzheimer   s disease (AD), and a second, pending
U.S. Food and Drug Administration (FDA) approval,
would treat depression in a new way. In 2023,
we are focused on executing on these and other
opportunities, while also reducing our cost base, as
we build on our 2022 results.
We maintained a strong financial position last year,
giving us the opportunity to invest prudently in our
business. We generated more than $10.1 billion in
revenue, while reducing overall expenses through our
cost reduction measures.
We ended the year with approximately $5.6 billion
in total cash, cash equivalents and marketable
securities. Allocating that capital will be a primary
focus for Biogen in 2023 as we look to rationalize
our cost base and achieve a meaningful return on
investment where we do invest.
I would like to thank you for your continued support of
and investment in Biogen. I outline below how in 2023
we intend to execute against several priorities.
Bringing two breakthrough medicines to market
In January 2023, the FDA granted accelerated
approval to LEQEMBI (lecanemab-irmb), a treatment
for early AD developed in collaboration with Eisai Co.,
Ltd (Eisai). The accelerated approval was based on
phase 2 data that demonstrated LEQEMBI reduced
the accumulation of amyloid-beta (A  ) plaque in the
brain, a defining feature of AD. The data from the
phase 3 CLARITY AD study provide clear evidence that
reducing plaque burden slows cognitive decline. After
decades of research, we can now see the promise of
potential disease modification.
With potential traditional approval     the Prescription
Drug User Fee Act (PDUFA) date is planned for
July 6, 2023     broader access could be within
reach of more patients. The Centers for Medicare
Biogen Annual Report 2022
1

CEO Letter
& Medicaid Services (CMS) announced its intent to
provide broader coverage on the same day within the
Coverage with Evidence Development framework.
We believe LEQEMBI represents a catalyst for further
innovation and is an incredible opportunity to build
upon as we invest in advancing the care of patients
suffering with AD. We continue to see progress in the
development of blood-based and digital biomarkers.
We imagine a world where early detection, before
the onset of symptoms, will have the potential to
allow treatment much earlier in the disease course
to potentially delay or even prevent AD. Biogen is
committed to continuing research in AD, including
investigation into a promising molecule in our
pipeline which could reduce tau, another defining
pathology of AD.
In collaboration with Sage Therapeutics Inc. (Sage),
we have advanced zuranolone, a potential treatment
for major depressive disorder (MDD) and postpartum
depression (PPD). If approved, zuranolone could be an
important new treatment option in an area with high
unmet need.
We have all seen the surge in mental illness the
last few years, and we know the current standard-ofcare antidepressants may not work for everyone or
may take up to six to eight weeks to reach maximal
efficacy when they do.
Zuranolone is currently under priority review at the
FDA as a potential 14-day, rapid-acting, once-daily, oral
medication to treat MDD and PPD following promising
phase 3 clinical trial results. Its novel mechanism of
action targets brain networks responsible for functions
such as mood, arousal, behavior and cognition and
could provide benefit as early as day three. With a
PDUFA date set for August 5, 2023, we are anticipating
a potential launch toward the end of the year in the
United States, and we are building our commercial
infrastructure and capabilities to enter this market.
Strengthening our portfolio and our pipeline,
and improving operational efficiency
We believe our return to a sustainable growth
trajectory will also require thoughtful portfolio and
pipeline optimization, external growth initiatives and
diligent cost management across the enterprise.
In our core business, we are working to deliver on
further growth opportunities in spinal muscular
atrophy (SMA) and improving our profitability in MS.
2
We have started a review of our strategic options for
our biosimilars business.
Our research and development pipeline and balance
sheet are strong, and we believe our pipeline will be
able to deliver significant growth over the medium
and long term. But there is still more we must do to
optimize our existing portfolio and diversify into new
therapeutic areas such as neuropsychiatry, specialized
immunology and rare diseases. We are closely
examining new paths to balancing and de-risking
our pipeline in a systemic and data-driven way, while
sharpening our focus on value generation in the areas
in which we have the most confidence, as compared
to the achievement of operational milestones alone.
Through internal research and development, thoughtful
business development, and disciplined capital allocation,
I believe we will create new opportunities for growth.
We also have the goal of bringing our cost base in
line with our revenue expectations while, at the same
time, investing in upcoming launches and potential
future growth drivers. We remain on track to achieve
our previously announced $1.0 billion in cost-saving
initiatives, and we will continue to seek new ways
to create shareholder value and achieve greater
operational efficiency.
Building on our heritage of innovation
As we approach the 45th anniversary of Biogen, it is a
privilege to lead such an established, purpose-driven
and diverse organization. I was drawn to join Biogen
not only for its reputation as a biotechnology pioneer,
but also by its dynamic team, which is as committed
to advancing health equity as it is to pioneering patient
breakthroughs. I have had the pleasure of getting to
know many talented employees over the past several
months and have witnessed firsthand their incredible
expertise, tenacity and passion for our mission. I look
forward to executing against our key milestones in 2023,
with the support of the accomplished team at Biogen,
our strong partnerships with collaborators like Eisai and
Sage, and the continued support of our shareholders.
Sincerely,
Christopher A. Viehbacher
President and Chief Executive Officer
Biogen Annual Report 2022


shareholder letter icon 4/28/2023 Letter Continued (Full PDF)
 

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