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2024 ANNUAL REPORT
CEO letter CEO LETTER Dear Shareholders, Over the past year, we continued to make strong progress on our journey to achieve sustainable growth, and we are implementing focused strategies with the aim to carry this momentum through 2025 and beyond. Biogen s core pharmaceutical business grew for the first time in four years, driven by continued revenue growth from our ongoing product launches supporting our long-term strategy. Building on the groundwork we set last year, this year we remain committed to the key priorities that drove that performance: strong financial discipline following our Fit for Growth Initiative to align Biogen s cost base, excellent execution on our new product launches, alignment of resources toward our strongest potential growth drivers, and pursuit of organic growth from our potentially transformative pipeline of life-changing medications, while supplementing those efforts with strategic transactions. We have evolved our research and development (R&D) model and implemented a new strategic approach to balance our differentiated internal capabilities with external investments in cutting-edge science. We anticipate this will enable greater flexibility, agility and efficiency, all with the goal of translating innovation into advancing new medicines faster. We achieved key development milestones across our late-stage pipeline in 2024 and are continuing to transform our product portfolio with a focus on diversification and value. We achieved key development milestones across our late-stage pipeline in 2024 and are continuing to transform our product portfolio with a focus on diversification and value. We are prioritizing highconviction assets we believe have potential to drive significant growth into the next decade, adopting a science- and value-driven governance structure, and applying a strategic criteria framework grounded in an investor mindset and aligned to our strategic roadmap. With a greater focus on key assets, we believe that our pipeline has the potential, over the coming years, to drive a new era of growth for Biogen. Christopher A. Viehbacher, President and Chief Executive Officer We are expanding our pipeline beyond neuroscience into a late-stage portfolio with an increased focus on immunology and rare and genetic diseases both areas where we have significant existing global development and commercialization capabilities. This is a multi-year journey, supported by potential catalysts to accelerate growth in our promising pipeline and by a reinvigorated research platform that we believe will fuel long-term sustainable growth. We expect important clinical readouts starting in 2026 with the potential to launch new treatments in 2028. Having strengthened our financial foundation, we also expect to have significant cash flow to continue investing in growth substrates and will carefully consider internal and external opportunities for innovation and value creation. Our focus is to stay resilient, stay the course on this journey, and remain financially disciplined as we focus on pipeline development and launch execution. 2024 Annual Report
CEO letter Executing on Key New Product Launches Biogen has always stood out as a pioneer in providing life-changing treatments to address areas of significant unmet need, and we were proud to extend that legacy in multiple ways last year. As expected, our multiple sclerosis (MS) franchise continued to face headwinds from increased competition from biosimilars and generic products. Nevertheless, the franchise demonstrated greater resilience than expected. Meanwhile, we were able to achieve success in our core pharmaceutical business through our team s execution across key pipeline launches. In 2025, we are focused on growing the four key products launched over the past two years LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY. These are each first-in-class products and the first diseasemodifying agents for the diseases they treat a true testament to the extraordinary innovation at the heart of Biogen. Pioneering new treatments always comes with challenges in educating providers, patients and patient advocates to achieve a treatment s full potential. We are deep into that education process now with each of these products and are deploying a differentiated strategy to drive each of them forward and reach even more patients across new markets. Pioneering new treatments always comes with challenges in educating providers, patients and patient advocates to achieve a treatment s full potential. First, as we stated last year, we remain firmly committed to Alzheimer s disease (AD), an area with significant unmet need and commercial opportunity. LEQEMBI demonstrated steady growth in 2024, with positive momentum and with seven additional regulatory approvals around the world. Looking ahead, we expect further catalysts for growth accelerating in 2025 and beyond. AD is complex with a unique treatment paradigm, and we continue to work with physicians and regulators to make treatment easier for patients and providers. In early 2025, we obtained U.S. Food and Drug Administration (FDA) approval for LEQEMBI intravenous (IV) maintenance, enabling patients to transition to a more convenient once-monthly dosing schedule following 18 months of biweekly infusions. We also expect to hear from the FDA in the second half of 2025 on the subcutaneous maintenance dose of LEQEMBI, which, if approved, will make maintenance more convenient with no need for an infusion suite for treatment. Additionally, we are working on introducing subcutaneous initiation dosing in 2026. In the European Union, the European Commission recently granted marketing authorization for LEQEMBI. AD is a progressive, fatal disease, and there is a growing awareness, and we believe, that continued treatment beyond initial amyloid plaque clearance may be needed to help maintain that clearance and slow progression. Data presented at Alzheimer s Association International Conference in 2024 from our open-label extension study showed that versus the natural disease history, LEQEMBI had continued benefit over three years in people with early AD. Last year, we completed enrollment of a landmark trial (AHEAD) in partnership with Eisai Co., Ltd. to study lecanemab for the treatment of pre-symptomatic AD patients, with an expected readout in 2028. This trial is critically important because if we can treat patients before they have symptoms, it has the potential to have a transformative impact on the population that may grapple with this devastating disease. Finally, the field is making significant strides in the development of blood-based diagnostics for AD that may make diagnosis easier, and there is the potential we may see an FDA approval on the first in vitro diagnostic test for AD this year. Further, we believe that in addition to targeting amyloid plaques, addressing tau pathology is crucial for effectively treating AD. We continue to invest in our broader AD pipeline, including our investigational anti-tau antisense oligonucleotide (ASO), BIIB080. We are expecting data from the ongoing Phase 2 CELIA study in 2026. Outside of AD, we believe we are making meaningful progress driving breakthroughs with potential applications in rare diseases. In 2024, we nearly doubled the number of patients on SKYCLARYS, which treats Friedreich ataxia (FA) in adults, and we see potential future growth drivers through geographic expansion and pediatric indication. SKYCLARYS is now approved in the European Union, and we expect additional approvals later this year in key markets in South America, where there is a particularly high prevalence of this rare genetic disease. When we acquired Reata Pharmaceuticals, Inc. in 2023, SKYCLARYS was approved only in the United States, and this medicine is now approved in 39 countries. In countries where we continue to negotiate reimbursement, we are now enrolling patients in Biogen Early Access Programs where possible. 2024 Annual Report
CEO letter In collaboration with UCB, last fall we announced positive Phase 3 results for dapirolizumab pegol, which is one of only three products ever to have demonstrated a positive global Phase 3 trial in lupus, and we have already initiated a second Phase 3 study to support a regulatory filing. We are also developing litifilimab, a first-in-class biologic for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). There is currently no treatment approved for CLE, and we have ongoing Phase 3 studies in both CLE and SLE, with expected readouts starting next year. With QALSODY, a breakthrough treatment for amyotrophic lateral sclerosis (ALS) in adults that have a very rare mutation in the superoxide dismutase 1 (SOD1) gene, we have delivered the first diseasemodifying therapy that can slow the progression of this always fatal disease. Biogen has been working on ALS for more than two decades, and while this area is not a large growth driver only 2,000 people worldwide are impacted by this disease we are proud of our longstanding commitment to this patient population. Our work in ALS also demonstrates our continued scientific leadership, as we have established that the level of neurofilaments can help predict whether drugs are likely to work or not early in the development process. This milestone paves the way for future development and applications in ALS and potentially other neurodegenerative diseases, including spinal muscular atrophy (SMA). As we continue to evaluate our pipeline and our clinical milestones, our utmost priority is maintaining a disciplined approach and constantly assessing inflection points as we advance through development. For SPINRAZA, we have filed with the FDA and in the European Union for approval of a high-dose product, which we believe has the potential to maximize efficacy outcomes. The DEVOTE study we completed in 2024 found that the higher dosage has the potential to be a safe and highly efficacious treatment, with an accelerated onset of the positive impacts to slow neurodegeneration. Finally, our most recent launch in 2024 ZURZUVAE exceeded our expectations. As the first ever oral treatment for postpartum depression (PPD), we are continuing to focus on educating providers and expanding our market reach, with regulatory approval in in the European Union expected later this year. Delivering a High Potential Pipeline Alongside new product launches, we are rebalancing the risk profile of our pipeline while investing to win in key areas of expected future growth, focusing on a smaller set of clinical-stage programs where we have high conviction and we believe are well positioned to deliver a regular cadence of pivotal readouts. We achieved important milestones to grow and advance our pipeline in immunology over the past year. Next, through the acquisition of Human Immunology Biosciences, Inc. (HI-Bio), we are advancing felzartamab for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients, and we are also exploring a range of applications for rare immune-mediated indications including primary membranous nephropathy (PMN) and IgA nephropathy (IgAN). In 2024, we received FDA Breakthrough Therapy Designation for the treatment of AMR, which provides us with additional opportunities to engage the FDA and to support the drug development program through Fast Track designation features. With proof of concept established across AMR, IgAN and PMN, we believe felzartamab has the potential to significantly augment Biogen s immunology portfolio. While we have already initiated the Phase 3 study in AMR, we expect to initiate additional Phase 3 studies in IgAN and PMN by the end of 2025. As we continue to evaluate our pipeline and our clinical milestones, our utmost priority is maintaining a disciplined approach and constantly assessing inflection points as we advance through development. With two assets in late-stage development, we believe lupus is a significant opportunity for the near term. Biogen s learnings and expertise in MS, in addition to our expertise in helping patients navigate complex systems and reimbursement programs, can be applied to lupus. There is also significant unmet patient need here, with 5 million patients worldwide with a wide range of symptoms, different organ involvement, and limited treatment options on the market. 2024 Annual Report
 • shareholder letter icon 4/25/2025 Letter Continued (Full PDF)
 • stockholder letter icon 4/28/2023 BIIB Stockholder Letter
 • stockholder letter icon 4/26/2024 BIIB Stockholder Letter
 • stockholder letter icon More "Biotechnology" Category Stockholder Letters
 • Benford's Law Stocks icon BIIB Benford's Law Stock Score = 99


BIIB Shareholder/Stockholder Letter Transcript:

2024
ANNUAL
REPORT


CEO letter
CEO LETTER
Dear Shareholders,
Over the past year, we continued to make strong
progress on our journey to achieve sustainable growth,
and we are implementing focused strategies with the
aim to carry this momentum through 2025 and beyond.
Biogen   s core pharmaceutical business grew for the
first time in four years, driven by continued revenue
growth from our ongoing product launches supporting
our long-term strategy. Building on the groundwork we
set last year, this year we remain committed to the key
priorities that drove that performance: strong financial
discipline following our Fit for Growth Initiative to align
Biogen   s cost base, excellent execution on our new
product launches, alignment of resources toward our
strongest potential growth drivers, and pursuit of organic
growth from our potentially transformative pipeline of
life-changing medications, while supplementing those
efforts with strategic transactions.
We have evolved our research and development (R&D)
model and implemented a new strategic approach to
balance our differentiated internal capabilities with
external investments in cutting-edge science. We
anticipate this will enable greater flexibility, agility and
efficiency, all with the goal of translating innovation into
advancing new medicines faster.
We achieved key
development milestones across
our late-stage pipeline in 2024
and are continuing to transform
our product portfolio with a focus
on diversification and value.   
We achieved key development milestones across
our late-stage pipeline in 2024 and are continuing
to transform our product portfolio with a focus on
diversification and value. We are prioritizing highconviction assets we believe have potential to drive
significant growth into the next decade, adopting a
science- and value-driven governance structure, and
applying a strategic criteria framework grounded in an
investor mindset and aligned to our strategic roadmap.
With a greater focus on key assets, we believe that our
pipeline has the potential, over the coming years, to
drive a new era of growth for Biogen.
Christopher A. Viehbacher, President and
Chief Executive Officer
We are expanding our pipeline beyond neuroscience
into a late-stage portfolio with an increased focus on
immunology and rare and genetic diseases     both areas
where we have significant existing global development
and commercialization capabilities. This is a multi-year
journey, supported by potential catalysts to accelerate
growth in our promising pipeline and by a reinvigorated
research platform that we believe will fuel long-term
sustainable growth. We expect important clinical
readouts starting in 2026 with the potential to launch
new treatments in 2028. Having strengthened our
financial foundation, we also expect to have significant
cash flow to continue investing in growth substrates and
will carefully consider internal and external opportunities
for innovation and value creation. Our focus is to
stay resilient, stay the course on this journey, and
remain financially disciplined as we focus on pipeline
development and launch execution.
2024 Annual Report

CEO letter
Executing on Key New Product Launches
Biogen has always stood out as a pioneer in providing
life-changing treatments to address areas of significant
unmet need, and we were proud to extend that legacy
in multiple ways last year. As expected, our multiple
sclerosis (MS) franchise continued to face headwinds
from increased competition from biosimilars and generic
products. Nevertheless, the franchise demonstrated
greater resilience than expected. Meanwhile, we were
able to achieve success in our core pharmaceutical
business through our team   s execution across key
pipeline launches. In 2025, we are focused on growing
the four key products launched over the past two years    
LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY. These
are each first-in-class products and the first diseasemodifying agents for the diseases they treat     a true
testament to the extraordinary innovation at the heart of
Biogen. Pioneering new treatments always comes with
challenges in educating providers, patients and patient
advocates to achieve a treatment   s full potential. We are
deep into that education process now with each of these
products and are deploying a differentiated strategy
to drive each of them forward and reach even more
patients across new markets.
Pioneering new treatments always
comes with challenges in educating
providers, patients and patient advocates
to achieve a treatment   s full potential.   
First, as we stated last year, we remain firmly committed
to Alzheimer   s disease (AD), an area with significant
unmet need and commercial opportunity. LEQEMBI
demonstrated steady growth in 2024, with positive
momentum and with seven additional regulatory
approvals around the world. Looking ahead, we expect
further catalysts for growth accelerating in 2025
and beyond. AD is complex with a unique treatment
paradigm, and we continue to work with physicians
and regulators to make treatment easier for patients
and providers. In early 2025, we obtained U.S. Food
and Drug Administration (FDA) approval for LEQEMBI
intravenous (IV) maintenance, enabling patients to
transition to a more convenient once-monthly dosing
schedule following 18 months of biweekly infusions.
We also expect to hear from the FDA in the second half
of 2025 on the subcutaneous maintenance dose of
LEQEMBI, which, if approved, will make maintenance
more convenient with no need for an infusion suite for
treatment. Additionally, we are working on introducing
subcutaneous initiation dosing in 2026. In the
European Union, the European Commission recently
granted marketing authorization for LEQEMBI.
AD is a progressive, fatal disease, and there is a
growing awareness, and we believe, that continued
treatment beyond initial amyloid plaque clearance may
be needed to help maintain that clearance and slow
progression. Data presented at Alzheimer   s Association
International Conference in 2024 from our open-label
extension study showed that versus the natural disease
history, LEQEMBI had continued benefit over three years
in people with early AD.
Last year, we completed enrollment of a landmark trial
(AHEAD) in partnership with Eisai Co., Ltd. to study
lecanemab for the treatment of pre-symptomatic AD
patients, with an expected readout in 2028. This trial
is critically important because if we can treat patients
before they have symptoms, it has the potential to
have a transformative impact on the population that
may grapple with this devastating disease. Finally, the
field is making significant strides in the development
of blood-based diagnostics for AD that may make
diagnosis easier, and there is the potential we may see
an FDA approval on the first in vitro diagnostic test for
AD this year.
Further, we believe that in addition to targeting
amyloid plaques, addressing tau pathology is crucial
for effectively treating AD. We continue to invest
in our broader AD pipeline, including our investigational
anti-tau antisense oligonucleotide (ASO), BIIB080.
We are expecting data from the ongoing Phase 2 CELIA
study in 2026.
Outside of AD, we believe we are making meaningful
progress driving breakthroughs with potential
applications in rare diseases. In 2024, we nearly
doubled the number of patients on SKYCLARYS, which
treats Friedreich ataxia (FA) in adults, and we see
potential future growth drivers through geographic
expansion and pediatric indication. SKYCLARYS is
now approved in the European Union, and we expect
additional approvals later this year in key markets
in South America, where there is a particularly high
prevalence of this rare genetic disease. When we
acquired Reata Pharmaceuticals, Inc. in 2023,
SKYCLARYS was approved only in the United States,
and this medicine is now approved in 39 countries.
In countries where we continue to negotiate
reimbursement, we are now enrolling patients in Biogen
Early Access Programs where possible.
2024 Annual Report

CEO letter
In collaboration with UCB, last fall we announced
positive Phase 3 results for dapirolizumab pegol, which
is one of only three products ever to have demonstrated
a positive global Phase 3 trial in lupus, and we have
already initiated a second Phase 3 study to support a
regulatory filing. We are also developing litifilimab, a
first-in-class biologic for systemic lupus erythematosus
(SLE) and cutaneous lupus erythematosus (CLE). There
is currently no treatment approved for CLE, and we have
ongoing Phase 3 studies in both CLE and SLE, with
expected readouts starting next year.
With QALSODY, a breakthrough treatment for
amyotrophic lateral sclerosis (ALS) in adults that have
a very rare mutation in the superoxide dismutase 1
(SOD1) gene, we have delivered the first diseasemodifying therapy that can slow the progression of this
always fatal disease. Biogen has been working on ALS
for more than two decades, and while this area is not
a large growth driver     only 2,000 people worldwide
are impacted by this disease     we are proud of our
longstanding commitment to this patient population.
Our work in ALS also demonstrates our continued
scientific leadership, as we have established that
the level of neurofilaments can help predict whether
drugs are likely to work or not early in the development
process. This milestone paves the way for future
development and applications in ALS and potentially
other neurodegenerative diseases, including spinal
muscular atrophy (SMA).
As we continue to evaluate our
pipeline and our clinical milestones, our
utmost priority is maintaining a
disciplined approach and constantly
assessing inflection points as we
advance through development.
For SPINRAZA, we have filed with the FDA and in the
European Union for approval of a high-dose product,
which we believe has the potential to maximize efficacy
outcomes. The DEVOTE study we completed in 2024
found that the higher dosage has the potential to
be a safe and highly efficacious treatment, with an
accelerated onset of the positive impacts to slow
neurodegeneration.
Finally, our most recent launch in 2024     ZURZUVAE    
exceeded our expectations. As the first ever oral
treatment for postpartum depression (PPD), we
are continuing to focus on educating providers and
expanding our market reach, with regulatory approval
in in the European Union expected later this year.
Delivering a High Potential Pipeline
Alongside new product launches, we are rebalancing the
risk profile of our pipeline while investing to win in key
areas of expected future growth, focusing on a smaller
set of clinical-stage programs where we have high
conviction and we believe are well positioned to deliver
a regular cadence of pivotal readouts. We achieved
important milestones to grow and advance our pipeline
in immunology over the past year.
Next, through the acquisition of Human Immunology
Biosciences, Inc. (HI-Bio), we are advancing felzartamab
for the treatment of late antibody-mediated rejection
(AMR) without T-cell mediated rejection in kidney
transplant patients, and we are also exploring a range
of applications for rare immune-mediated indications    
including primary membranous nephropathy (PMN)
and IgA nephropathy (IgAN). In 2024, we received FDA
Breakthrough Therapy Designation for the treatment of
AMR, which provides us with additional opportunities to
engage the FDA and to support the drug development
program through Fast Track designation features.
With proof of concept established across AMR, IgAN
and PMN, we believe felzartamab has the potential to
significantly augment Biogen   s immunology portfolio.
While we have already initiated the Phase 3 study in
AMR, we expect to initiate additional Phase 3 studies
in IgAN and PMN by the end of 2025. As we continue
to evaluate our pipeline and our clinical milestones, our
utmost priority is maintaining a disciplined approach
and constantly assessing inflection points as we
advance through development.
With two assets in late-stage development, we believe
lupus is a significant opportunity for the near term.
Biogen   s learnings and expertise in MS, in addition
to our expertise in helping patients navigate complex
systems and reimbursement programs, can be applied
to lupus. There is also significant unmet patient need
here, with 5 million patients worldwide with a wide range
of symptoms, different organ involvement, and limited
treatment options on the market.
2024 Annual Report



shareholder letter icon 4/25/2025 Letter Continued (Full PDF)
 

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