BIOGEN INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q)

May 03, 2022 at 04:25 pm EDT

The following discussion should be read in conjunction with our unaudited
condensed consolidated financial statements (condensed consolidated financial
statements) and the accompanying notes beginning on page 5 of this quarterly
report on Form 10-Q and our audited consolidated financial statements and the
accompanying notes included in our Annual Report on Form 10-K for the year ended
December 31, 2021 (2021 Form 10-K).

Executive Summary

Introduction



Biogen is a global biopharmaceutical company focused on discovering, developing
and delivering worldwide innovative therapies for people living with serious
neurological and neurodegenerative diseases as well as related therapeutic
adjacencies. We have a leading portfolio of medicines to treat multiple
sclerosis (MS), have introduced the first approved treatment for spinal muscular
atrophy (SMA) and are providing the first and only approved treatment to address
a defining pathology of Alzheimer's disease. We also commercialize biosimilars
of advanced biologics and focus on advancing our pipeline in neuroscience and
specialized immunology. Lastly, we are focused on accelerating our efforts in
digital health to support our commercial and pipeline programs while also
creating opportunities for potential digital therapeutics. We support our drug
discovery and development efforts through the commitment of significant
resources to discovery, research and development programs and business
development opportunities.

Our marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and
FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; ADUHELM for
the treatment of Alzheimer's disease; and FUMADERM for the treatment of severe
plaque psoriasis. We have certain business and financial rights with respect to
RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic
leukemia (CLL) and other conditions; RITUXAN HYCELA for the treatment of
non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular
lymphoma; OCREVUS for the treatment of primary progressive MS and relapsing MS
(RMS); and other potential anti-CD20 therapies, including mosunetuzumab,
pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a
wholly-owned member of the Roche Group. For additional information on our
collaboration arrangements with Genentech, please read Note 18,

Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K.



Our innovative drug development and commercialization activities are
complemented by our biosimilar business that expands access to medicines and
reduces the cost burden for healthcare systems. Through our collaboration with
Samsung Bioepis Co., Ltd. (Samsung Bioepis) we market and sell BENEPALI, an
etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar
referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE,
in certain countries in Europe. We have also secured the exclusive rights to
commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, which was
approved in the United States (U.S.), the European Union (E.U.) and the United
Kingdom (U.K.) during the third quarter of 2021. For additional information on
our collaboration arrangements with Samsung Bioepis, please read Note 16,
Collaborative and Other Relationships, to our condensed consolidated financial
statements included in this report.

We seek to ensure an uninterrupted supply of medicines to patients around the
world. To that end, we continually review our manufacturing capacity,
capabilities, processes and facilities. In order to support our future growth
and drug development pipeline, we are expanding our large molecule production
capacity by building a large-scale biologics manufacturing facility in
Solothurn, Switzerland. In the second quarter of 2021 a portion of the facility
received a Good Manufacturing Practice (GMP) multi-product license from the
Swiss Agency for Therapeutic Products (SWISSMEDIC). In April 2022 the U.S. Food
and Drug Administration (FDA) approved the Prior Approval Supplement for the
Solothurn facility for ADUHELM. We estimate the remainder of the facility will
be operational during the first half of 2023. We believe that the Solothurn
facility will support our anticipated near-term needs for the manufacturing of
biologic assets. In addition, we believe that the Solothurn facility may provide
us with the ability to further expand if we need additional large scale
manufacturing capacity to support future clinical and commercial manufacturing
requirements. If we are unable to fully utilize our manufacturing facilities,
due to lower than forecasted demand for our products, we will incur excess
capacity charges which will have a negative effect on our financial condition
and results of operations.

Our revenue depends upon continued sales of our products as well as the
financial rights we have in our anti-CD20 therapeutic programs, and, unless we
develop, acquire rights to and/or commercialize new products and technologies,
we will be substantially dependent on sales from our products and our
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financial rights in our anti-CD20 therapeutic programs for many years.



In the longer term, our revenue growth will depend upon the successful clinical
development, regulatory approval and launch of new commercial products as well
as additional indications for our existing products, our ability to obtain and
maintain patents and other rights related to our marketed products, assets
originating from our research and development efforts and/or successful
execution of external business development opportunities.

Business Environment



The biopharmaceutical industry and the markets in which we operate are intensely
competitive. Many of our competitors are working to develop or have
commercialized products similar to those we market or are developing and have
considerable experience in undertaking clinical trials and in obtaining
regulatory approval to market pharmaceutical products. In addition, the
commercialization of certain of our own approved products, products of our
collaborators and pipeline product candidates may negatively impact future sales
of our existing products.

Our products and revenue streams continue to face increasing competition in many
markets from generic versions, prodrugs and biosimilars of existing products as
well as products approved under abbreviated regulatory pathways. Such products
are likely to be sold at substantially lower prices than branded products.
Accordingly, the introduction of such products as well as other lower-priced
competing products may significantly reduce both the price that we are able to
charge for our products and the volume of products we sell, which will
negatively impact our revenue. In addition, in some markets, when a generic or
biosimilar version of one of our products is commercialized, it may be
automatically substituted for our product and significantly reduce our revenue
in a short period of time.

Sales of our products depend, to a significant extent, on the availability and
extent of adequate coverage, pricing and reimbursement from government health
administration authorities, private health insurers and other organizations.
When a new pharmaceutical product is approved, the availability of government
and private reimbursement for that product may be uncertain, as is the pricing
and amount for which that product will be reimbursed.

Drug prices are under significant scrutiny in the markets in which our products
are prescribed. We expect drug pricing and other health care costs to continue
to be subject to intense political and societal pressures on a global basis.

Our failure to obtain or maintain adequate coverage, pricing or reimbursement for our products



could have an adverse effect on our business, reputation, revenue and results of
operations, could curtail or eliminate our ability to adequately fund research
and development programs for the discovery and commercialization of new products
and/or could cause a decline or volatility in our stock price.

In addition to the impact of competition, pricing actions and other measures
being taken worldwide designed to reduce healthcare costs and limit the overall
level of government expenditures, our sales and operations could also be
affected by other risks of doing business internationally, including the impact
of public health epidemics, such as the COVID-19 pandemic, on employees, the
global economy and the delivery of healthcare treatments, geopolitical events,
foreign currency exchange fluctuations, changes in intellectual property legal
protections and changes in trade regulations and procedures.

For a detailed discussion on our business environment, please read Item 1.
Business, in our 2021 Form 10-K. For additional information on our competition
and pricing risks that could negatively impact our product sales, please read
Item 1A. Risk Factors included in this report.

ADUHELM (aducanumab)

U.S.



In June 2021 the FDA granted accelerated approval of ADUHELM, which we are
collaborating on with Eisai Co., Ltd. (Eisai), based on reduction in amyloid
beta plaques observed in patients treated with ADUHELM. As part of the
accelerated approval, we are required to conduct a confirmatory trial to verify
the clinical benefit of ADUHELM in patients with Alzheimer's disease. The FDA
may withdraw approval if, among other things, the confirmatory trial fails to
verify clinical benefit of ADUHELM, ADUHELM's benefit-risk is no longer positive
or we fail to comply with the conditions of the accelerated approval.

The U.S. ADUHELM product label states that treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population which was studied in clinical trials.



In January 2022 the Centers for Medicare and Medicaid Services (CMS) released a
proposed National Coverage Determination (NCD) decision memorandum, stating the
proposed NCD would cover FDA approved monoclonal antibodies that target amyloid
for the treatment of Alzheimer's disease for people with Medicare only if they
are enrolled in qualifying clinical trials.

In April 2022 CMS released the final NCD for the class of anti-amyloid treatments in Alzheimer's disease, including ADUHELM. The final NCD confirmed coverage with evidence development, in which

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patients with Medicare can only access treatment if they are part of an approved
clinical trial. We expect that this decision will reduce future demand for
ADUHELM to a minimal level. During the first quarter of 2022 we wrote-off
approximately $275.0 million of gross charges associated with inventory and
purchase commitments related to ADUHELM and recognized approximately
$45.0 million of gross idle capacity charges, as a result of this CMS decision,
which were recognized in cost of sales within our condensed consolidated
statements of income. We have recognized approximately $160.0 million related to
Eisai's 45.0% share of these charges in collaboration profit (loss) sharing
within our condensed consolidated statements of income.

Additionally, as a result of the final NCD we will substantially eliminate our
commercial infrastructure supporting ADUHELM, retaining minimal resources to
manage patient access programs, including a continued free drug program for
patients currently on treatment in the U.S.

We expect to continue funding certain regulatory and research and development
activities for ADUHELM, including the continuation of the EMBARK re-dosing study
and the initiation of the Phase 4 post-marketing requirement study, ENVISION.
Additional actions regarding ADUHELM may be informed by upcoming data readouts
expected for this class of antibodies, as well as further engagement with the
FDA and CMS.

In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai.
Effective March 2022 we have sole decision making and commercialization rights
worldwide on ADUHELM and beginning January 1, 2023, Eisai will receive a tiered
royalty based on net sales of ADUHELM, rather than sharing global profits and
losses. Eisai's share of development, commercialization and manufacturing
expense is limited to $335.0 million for the period from January 1, 2022 to
December 31, 2022. Once the tiered royalty model commences on January 1, 2023,
Eisai will not participate in ADUHELM's economics beyond these royalties.

Rest of World



In October 2020 the European Medicines Agency (EMA) accepted for review the
Marketing Authorization Application (MAA) for aducanumab and in December 2020
the Ministry of Health, Labor and Welfare accepted for review the Japanese New
Drug Application (NDA) for aducanumab.

In December 2021 the Committee for Medicinal Products for Human Use (CHMP) of
the EMA adopted a negative opinion on the MAA for aducanumab in Europe. We
sought re-examination of the opinion by the CHMP. In April 2022 we announced our
decision to withdraw our MAA for aducanumab in Europe.

If we do not receive regulatory approval or are unable to successfully commercialize aducanumab in

other jurisdictions, our financial condition, business and operations may be adversely affected.



TECFIDERA

In 2020 U.S. federal courts in West Virginia and Delaware entered judgments in
favor of the defendants in patent infringement proceedings relating to TECFIDERA
Orange-Book listed patents. We appealed both decisions. In late 2021 the U.S.
Court of Appeals for the Federal Circuit (Federal Circuit) affirmed the judgment
of the West Virginia federal court. The appeals in the actions in Delaware are
stayed.

Multiple TECFIDERA generic entrants are now in the U.S. market and have deeply
discounted prices compared to TECFIDERA. The generic competition for TECFIDERA
has significantly reduced our TECFIDERA revenue and is expected to continue to
have a substantial and increasing negative impact on our U.S. TECFIDERA revenue
in the future.

In May 2021 the European General Court annulled the EMA's decision not to
validate applications for approval of TECFIDERA generics on the basis that the
EMA conducted the wrong assessment when determining TECFIDERA's entitlement to
regulatory data and marketing protection. Our Company, the EMA and the European
Commission (EC) have each appealed the General Court's decision as wrongly
decided and the appeal is pending.

In November 2021 the CHMP of the EMA issued an ad hoc opinion referencing the
General Court's decision which concluded that "the totality of the available
data cannot establish that [monoethyl fumarate] exerts a clinically relevant
therapeutic contribution within FUMADERM." The EC will decide TECFIDERA's
entitlement to regulatory data and market protection. If data and market
protection is not upheld, we could face generic competition in the E.U. as early
as the first half of 2022, which would have an adverse impact on our TECFIDERA
sales in the E.U. and our results of operations.

For additional information, please read Note 18, Litigation, to our condensed
consolidated financial statements included in this report and the discussion
under Results of Operations - Product Revenue - Multiple Sclerosis (MS) -
Fumarate below.
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Business Update Regarding COVID-19 and Other Disruptions

COVID-19



The COVID-19 pandemic continues to present a substantial public health and
economic challenge around the world. The length of time and full extent to which
the COVID-19 pandemic directly or indirectly impacts our business, results of
operations and financial condition, including sales, expense, reserves and
allowances, the supply chain, manufacturing, clinical trials, research and
development costs and employee-related costs, depends on future developments
that are highly uncertain, subject to change and are difficult to predict,
including as a result of new information that may emerge concerning COVID-19 and
the actions taken to contain or treat COVID-19 as well as the economic impact on
local, regional, national and international customers and markets.

We are monitoring the demand for our products, including the duration and degree
to which we may see delays in starting new patients on a product due to
hospitals diverting the resources that are necessary to administer certain of
our products to care for COVID-19 patients, including products, such as TYSABRI
and SPINRAZA, that are administered in a physician's office or hospital setting.
We may also see reduced demand for immunosuppressant therapies during the
COVID-19 pandemic.

While we are currently continuing the clinical trials we have underway in sites
across the globe, COVID-19 precautions have impacted the timeline for some of
our clinical trials and these precautions may, directly or indirectly, have a
further impact on timing in the future. To help mitigate the impact of the
COVID-19 pandemic to our clinical trials, we are pursuing innovative approaches
such as remote monitoring, remote patient visits and supporting home infusions.
These alternative measures have resulted in an immaterial increase to the cost
of the clinical trials underway.

Conflict in Ukraine



The ongoing geopolitical tensions related to Russia's invasion of Ukraine have
resulted in global business disruptions and economic volatility, including
sanctions and other restrictions levied on the government and businesses in
Russia. Although we do not have affiliates or employees, in either Russia or
Ukraine, we do provide various therapies to patients in Russia through a
distributor and are currently involved in clinical trials with sites in Ukraine
and Russia. The timing and costs of these trials may be impacted as a result of
the conflict. For example, the development of orelabrutinib, an oral small
molecule Bruton's tyrosine kinase inhibitor for the potential treatment of MS,
that we are developing with

InnoCare has been delayed and will require the establishment of new clinical sites in other geographies.



The impact of the conflict on our operations and financial performance remains
uncertain and will depend on future developments, including the severity and
duration of the conflict, its impact on regional and global economic conditions
and whether the conflict spreads or has effects on countries outside Ukraine and
Russia. Revenue generated from sales in these regions represented less than 2.0%
of total product revenue for the three months ended March 31, 2022 and the year
ended December 31, 2021.

We will continue to monitor the ongoing conflict between Russia and Ukraine and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations.



Factors such as the COVID-19 pandemic, adverse weather events, geopolitical
events, labor or raw material shortages and other supply chain disruptions could
result in product shortages or other difficulties and delays or increased costs
in manufacturing our products.

For additional information on the various risks posed by the COVID-19 pandemic
and Russia's invasion of Ukraine, please read Item 1A. Risk Factors included in
this report.

Financial Highlights

Diluted earnings per share attributable to Biogen Inc. was $2.06 for the three
months ended March 31, 2022, representing a decrease of 23.4% compared to $2.69
in the same period in 2021.

As described below under Results of Operations, our net income and diluted earnings per share attributable to Biogen Inc. for the three months ended March 31, 2022, compared to the three months ended March 31, 2021, reflects the following:

Revenue



•Total revenue was $2,531.8 million for the first quarter of 2022, representing
a $162.2 million, or 6.0%, decrease compared to $2,694.0 million in the same
period in 2021.

•Product revenue, net totaled $2,066.3 million for the first quarter of 2022,
representing a $145.4 million, or 6.6%, decrease compared to $2,211.7 million in
the same period in 2021. This decrease was primarily due to an $88.8 million, or
6.0%, decrease in MS product revenue and a $48.0 million, or 9.2%, decrease in
SPINRAZA product revenue.

•The decrease in MS product revenue was primarily due to a decrease in

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rest of world Interferon demand due to increasing competition from our other MS
products as well as other treatments for MS, including biosimilars. The decrease
was also due to a decrease in U.S. TECFIDERA demand as a result of multiple
TECFIDERA generic entrants in the U.S. market.

•The decrease in SPINRAZA revenue was primarily due to a decrease in demand as a
result of increased competition in certain established markets, particularly
Germany, and the timing of shipments, as well as the unfavorable impact of
foreign currency exchange.

•Revenue from anti-CD20 therapeutic programs totaled $399.4 million for the
first quarter of 2022, representing a $10.4 million, or 2.7%, increase compared
to $389.0 million in the same period in 2021. This increase was primarily due to
a $43.0 million, or 20.5%, increase in royalty revenue on sales of OCREVUS,
partially offset by a $31.0 million, or 19.5%, decrease in RITUXAN revenue.
Sales of RITUXAN have been adversely affected by the onset of biosimilars
competition.

•Other revenue totaled $66.1 million for the first quarter of 2022, representing a $27.2 million, or 29.2% decrease from $93.3 million in the same period in 2021.

Expense



•Total cost and expense was $1,921.1 million for the first quarter of 2022,
representing a $201.0 million, or 11.7%, increase compared to $1,720.1 million
in the same period in 2021.

•This increase was primarily due to a $275.8 million, or 57.7%, increase in cost
of sales, driven by approximately $275.0 million of gross charges associated
with inventory and purchase commitments in excess of forecasted demand related
to ADUHELM, as well as approximately $45.0 million of gross idle capacity
charges.

•The increase in cost and expense for the first quarter of 2022 also reflects an increase in selling, general and administrative expense due to ADUHELM commercialization expense of approximately $80.0 million and

restructuring charges of approximately $38.1 million related to our 2022 cost saving initiatives.

As described below under Financial Condition, Liquidity and Capital Resources:

•We generated $161.8 million of net cash flow from operations for the three months ended March 31, 2022.

•Cash, cash equivalents and marketable securities totaled approximately $4,753.3 million as of March 31, 2022.



•There were no share repurchases of our common stock during the first quarter of
2022 under a program authorized by our Board of Directors in October 2020 to
repurchase up to $5.0 billion of our common stock (2020 Share Repurchase
Program). Approximately $2.8 billion remained available under our 2020 Share
Repurchase Program as of March 31, 2022.

Collaborative and Other Relationships

For additional information on our collaborative and other relationships discussed below, please read Note 16, Collaborative and Other Relationships, and Note 17, Investments in Variable Interest Entities, to our condensed consolidated financial statements included in this report.

Samsung Bioepis - Biogen's Joint Venture with Samsung BioLogics



In January 2022 we entered into an agreement to sell to Samsung BioLogics our
equity in Samsung Bioepis, which was completed on April 20, 2022. Under the
terms of the transaction, we received approximately $1.0 billion in cash at
closing and will receive approximately $1.3 billion to be deferred over two
payments of $812.5 million due at the first anniversary and $437.5 million due
at the second anniversary of the closing of the transaction. We are also
eligible to receive up to an additional $50.0 million upon the achievement of
certain commercial milestones.

For additional information on the transaction and our collaboration arrangements
with Samsung Bioepis, please read Note 16, Collaborative and Other
Relationships, to our condensed consolidated financial statements included in
this report.

Eisai Collaboration Agreements

ADUHELM Collaboration Agreement

In March 2022 we amended our ADUHELM Collaboration Agreement with Eisai. Effective March 2022 we have sole decision making and commercialization rights worldwide on ADUHELM and beginning January 1, 2023, Eisai will receive a tiered

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royalty based on net sales of ADUHELM, rather than sharing global profits and
losses. Eisai's share of development, commercialization and manufacturing
expense is limited to $335.0 million for the period from January 1, 2022 to
December 31, 2022. Once the tiered royalty model commences on January 1, 2023,
Eisai will not participate in ADUHELM's economics beyond these royalties.

Lecanemab Collaboration

In March 2022 we extended our supply agreement related to lecanemab from 5 years to 10 years, and we will manufacture the lecanemab drug substance in our Solothurn manufacturing facility.

For additional information on our collaboration arrangements with Eisai, please read Note 16, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

Other Key Developments

2022 Cost Saving Initiatives



In December 2021 and May 2022 we announced our plans to implement a series of
cost-reduction measures during 2022. These savings are expected to be achieved
through a number of initiatives, including reductions to our workforce,
primarily within our global Alzheimer's infrastructure, the consolidation of
certain real estate locations and operating efficiency gains across our selling,
general and administrative and research and development functions.

Under these initiatives, we expect to incur restructuring charges ranging from
approximately $100.0 million to $150.0 million. These amounts are primarily
related to severance and are expected to be substantially incurred and paid by
the end of 2022.

For additional information on our 2022 cost saving initiatives, please read Note
2, Restructuring, Business Transformation and Other Cost Saving Initiatives, to
our condensed consolidated financial statements included in this report.
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RESULTS OF OPERATIONS

Revenue

Revenue is summarized as follows:


                                                                                  For the Three Months Ended March 31,
(In millions, except percentages)                          2022                                   2021                     $ Change            % Change
Product revenue, net:
United States                                $      875.2              34.6  %       $   899.8              33.4  %       $  (24.6)                 (2.7) %
Rest of world                                     1,191.1              47.0            1,311.9              48.7            (120.8)                 (9.2)
Total product revenue, net                        2,066.3              81.6            2,211.7              82.1            (145.4)                 (6.6)
Revenue from anti-CD20 therapeutic
programs                                            399.4              15.8              389.0              14.4              10.4                   2.7
Other revenue                                        66.1               2.6               93.3               3.5             (27.2)                (29.2)
Total revenue                                $    2,531.8             100.0  %       $ 2,694.0             100.0  %       $ (162.2)                 (6.0) %



Product Revenue

Product revenue is summarized as follows:


                                                                                   For the Three Months Ended March 31,
(In millions, except percentages)                           2022                                   2021                     $ Change            % Change
Multiple Sclerosis (MS):
Fumarate(1)                                   $      537.9              26.0  %       $   552.9              25.0  %       $  (15.0)                 (2.7) %
Interferon(2)                                        309.6              15.0              400.5              18.1             (90.9)                (22.7)
TYSABRI                                              520.8              25.2              503.3              22.8              17.5                   3.5
FAMPYRA                                               26.2               1.3               26.6               1.2              (0.4)                 (1.5)
Subtotal: MS                                       1,394.5              67.5            1,483.3              67.1             (88.8)                 (6.0)

Spinal Muscular Atrophy:
SPINRAZA                                             472.5              22.9              520.5              23.5             (48.0)                 (9.2)

Alzheimer's disease:
ADUHELM(3)                                             2.8               0.1                  -                 -               2.8                       nm

Biosimilars:
BENEPALI                                             114.7               5.5              121.7               5.5              (7.0)                 (5.8)
IMRALDI                                               57.1               2.8               57.9               2.6              (0.8)                 (1.4)
FLIXABI                                               22.5               1.1               25.5               1.2              (3.0)                (11.8)
Subtotal: Biosimilars                                194.3               9.4              205.1               9.3             (10.8)                 (5.3)

Other:
FUMADERM                                               2.2               0.1                2.8               0.1              (0.6)                (21.4)
Total product revenue, net                    $    2,066.3             100.0  %       $ 2,211.7             100.0  %       $ (145.4)                 (6.6) %




(1) Fumarate includes TECFIDERA and VUMERITY. VUMERITY became commercially
available in the E.U. during the fourth quarter of 2021.
(2) Interferon includes AVONEX and PLEGRIDY.
(3) In June 2021 the FDA granted accelerated approval of ADUHELM, which became
commercially available in the U.S. during the second quarter of 2021. For
additional information, please read Note 16, Collaborative and Other
Relationships - Eisai Co., Ltd. - ADUHELM Collaboration Agreement, to our
condensed consolidated financial statements included in this report.
nm Not meaningful
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Multiple Sclerosis (MS)

Fumarate

[[Image Removed: biib-20220331_g2.jpg]]



Fumarate revenue includes sales from TECFIDERA and VUMERITY. During the fourth
quarter of 2021 VUMERITY was approved for the treatment of relapsing-remitting
MS (RRMS) in the E.U., Switzerland and the U.K.

For the three months ended March 31, 2022, compared to the same period in 2021,
the 2.7% increase in U.S. Fumarate revenue was primarily due to a favorable
adjustment of prior year estimates on Medicaid-related sales of VUMERITY. The
increase was also due to an increase in VUMERITY sales volumes in the U.S.,
partially offset by a decrease in TECFIDERA demand as a result of multiple
TECFIDERA generic entrants in the U.S. market.

For the three months ended March 31, 2022, compared to the same period in 2021, the 6.7% decrease in rest of world Fumarate revenue was primarily due to TECFIDERA pricing reductions in certain European countries.



In 2020 U.S. federal courts in West Virginia and Delaware entered judgments in
favor of the defendants in patent infringement proceedings relating to TECFIDERA
Orange-Book listed patents. We appealed both decisions. In late 2021 the Federal
Circuit affirmed the judgment of the West Virginia federal court. The appeals in
the actions in Delaware are stayed.

Multiple TECFIDERA generic entrants are now in the U.S. market and have deeply
discounted prices compared to TECFIDERA. The generic competition for TECFIDERA
has significantly reduced our TECFIDERA revenue and is expected to continue to
have a substantial and increasing negative impact on our U.S. TECFIDERA revenue
in the future.

In May 2021 the European General Court annulled the EMA's decision not to
validate applications for approval of TECFIDERA generics on the basis that the
EMA conducted the wrong assessment when determining TECFIDERA's entitlement to
regulatory data and marketing protection. Our Company, the EMA and the EC have
each appealed the General Court's decision as wrongly decided and the appeal is
pending.

In November 2021 the CHMP of the EMA issued an ad hoc opinion referencing the
General Court's decision which concluded that "the totality of the available
data cannot establish that [monoethyl fumarate] exerts a clinically relevant
therapeutic contribution within FUMADERM." The EC will decide TECFIDERA's
entitlement to regulatory data and market protection. If data and market
protection is not upheld, we could face generic competition in the E.U. as early
as the first half of 2022, which would have an adverse impact on our TECFIDERA
sales in the E.U. and our results of operations.

For additional information, please read Note 18, Litigation, to our condensed consolidated financial statements included in this report.

We expect that TECFIDERA revenue will continue to decline in 2022, compared to 2021, as a result of increasing generic competition.

We expect an increase in VUMERITY sales volumes in 2022, compared to 2021, mostly due to demand growth, including the continued launch of VUMERITY in the E.U.

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Interferon

[[Image Removed: biib-20220331_g3.jpg]]



For the three months ended March 31, 2022, compared to the same period in 2021,
the 24.6% decrease in U.S. Interferon revenue was primarily due to a decrease in
Interferon sales volumes of 14.6% and a decrease in pricing of 10.0%. The net
decline in sales volumes reflects the continued decline of the Interferon market
as patients transition to other higher efficacy and oral MS therapies.

For the three months ended March 31, 2022, compared to the same period in 2021,
the 19.8% decrease in rest of world Interferon revenue was primarily due to a
decrease in Interferon sales volumes resulting from the continued decline of the
Interferon market.

We expect that Interferon revenue will continue to decline in both the U.S. and
rest of world markets in 2022, compared to 2021, as a result of increasing
competition from other MS products, including biosimilars, and further pricing
reductions in certain European markets.

TYSABRI

[[Image Removed: biib-20220331_g4.jpg]]



For the three months ended March 31, 2022, compared to the same period in 2021,
the 4.1% increase in U.S. TYSABRI revenue was primarily due to price increases,
partially offset by a decrease in sales volumes.

For the three months ended March 31, 2022, compared to the same period in 2021, the 2.7% increase in rest of world TYSABRI revenue was primarily due to favorable volume impacts, partially offset by a decrease in pricing.



We anticipate TYSABRI revenue to be relatively flat on a global basis in 2022,
compared to 2021, despite increasing competition from additional treatments for
MS. We expect to continue to face price reductions in certain European markets.
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Spinal Muscular Atrophy

SPINRAZA

[[Image Removed: biib-20220331_g5.jpg]]



For the three months ended March 31, 2022, compared to the same period in 2021,
the 9.8% increase in U.S. SPINRAZA revenue was primarily due to an increase in
sales volumes resulting from favorable channel dynamics.

For the three months ended March 31, 2022, compared to the same period in 2021,
the 16.8% decrease in rest of world SPINRAZA revenue was primarily due to a
decrease in sales volumes of 10.0% resulting from increased competition in
certain established markets, particularly Germany, and the timing of shipments,
as well as the unfavorable impact of foreign currency exchange. The decrease was
partially offset by sales volume growth in certain Asian markets.

We face competition from a gene therapy product and an oral product. In 2022 we
expect that SPINRAZA revenue will be subject to increased competition likely
resulting in continued patient discontinuations and a lower rate of new patient
starts combined with the impact of loading dose dynamics as patients transition
to dosing once every four months and lower prices in certain rest of world
countries.

For additional information on our collaboration arrangements with Ionis Pharmaceuticals, Inc. (Ionis), please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K.



Alzheimer's Disease

ADUHELM

[[Image Removed: biib-20220331_g6.jpg]]

In June 2021 the FDA granted accelerated approval of ADUHELM, which became commercially available in the U.S. during the second quarter of 2021.



In April 2022 the CMS released the final NCD for the class of anti-amyloid
treatments in Alzheimer's disease, including ADUHELM. The final NCD confirmed
coverage with evidence development, in which patients with Medicare can only
access treatment if they are part of an approved clinical trial. We expect that
this decision will reduce future demand for ADUHELM to a minimal level.

Additionally, as a result of the final NCD we will substantially eliminate our
commercial infrastructure supporting ADUHELM, retaining minimal resources to
manage patient access programs, including a continued free drug program for
patients currently on treatment in the U.S.

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Biosimilars

BENEPALI, IMRALDI and FLIXABI
[[Image Removed: biib-20220331_g7.jpg]]

For the three months ended March 31, 2022, compared to the same period in 2021,
the 5.3% decrease in biosimilar revenue was primarily due to a decrease in
pricing in certain markets and unfavorable foreign currency impact, partially
offset by an increase in sales volumes.

During the third quarter of 2021 BYOOVIZ, a biosimilar referencing LUCENTIS, was approved in the U.S., the E.U. and the U.K.



We anticipate a slight decline in revenue from our biosimilars business in 2022,
compared to 2021, despite the launch of BYOOVIZ in the U.S. and an anticipated
modest increase in sales volumes in 2022, as we continue to face price
reductions in certain markets.

For additional information on our collaboration arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

Revenue from Anti-CD20 Therapeutic Programs

Genentech (Roche Group)



Our share of RITUXAN, including RITUXAN HYCELA, and GAZYVA collaboration
operating profits in the U.S. and other revenue from anti-CD20 therapeutic
programs are summarized in the table below. For purposes of this discussion, we
refer to RITUXAN and RITUXAN HYCELA collectively as RITUXAN.
[[Image Removed: biib-20220331_g8.jpg]]
Biogen's Share of Pre-tax Profits in the U.S. for RITUXAN and GAZYVA

The following table provides a summary of amounts comprising our share of pre-tax profits in the U.S. for RITUXAN and GAZYVA:



                                                                For the Three Months Ended March 31,
(In millions)                                                      2022                       2021
Product revenue, net                                      $             455.0          $          551.4
Cost and expense                                                         59.8                      74.2
Pre-tax profits in the U.S.                                             395.2                     477.2
Biogen's share of pre-tax profits                         $

143.2 $ 174.1




For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in U.S. product revenue, net was primarily due to a decrease in
sales volumes of RITUXAN in the U.S. of 30.4%, primarily due to the onset of
competition from multiple biosimilar products and a decrease in GAZYVA sales
volumes of 3.6%.

For the three months ended March 31, 2022, compared to the same period in 2021, the decrease in collaboration costs and expense was primarily due

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to lower cost of sales, selling and marketing expense and distribution costs related to RITUXAN.



We are aware of several other anti-CD20 molecules, including biosimilar
products, that have been approved and are competing with RITUXAN and GAZYVA in
the oncology and other markets. In November 2019, January 2020 and January 2021
biosimilar products referencing RITUXAN were launched in the U.S. and are being
offered at lower prices. This competition has had a significant adverse impact
on the pre-tax profits of our collaboration arrangements with Genentech, as the
sales of RITUXAN have decreased substantially compared to prior periods. We
expect that biosimilar competition will continue to increase as these products
capture additional market share and that this will have a significant adverse
impact on our co-promotion profits in the U.S. in future years.

Other Revenue from Anti-CD20 Therapeutic Programs



Other revenue from anti-CD20 therapeutic programs consists of royalty revenue on
sales of OCREVUS and our share of pre-tax co-promotion profits from RITUXAN in
Canada.

For the three months ended March 31, 2022, compared to the same period in 2021,
the increase in other revenue from anti-CD20 therapeutic programs was primarily
due to sales growth of OCREVUS. Royalty revenue recognized on sales of OCREVUS
for the three months ended March 31, 2022, totaled $252.3 million compared to
$209.3 million in the prior year comparative period.

OCREVUS royalty revenue is based on our estimates from third party and market
research data of OCREVUS sales occurring during the corresponding period.
Differences between actual and estimated royalty revenue will be adjusted for in
the period in which they become known, which is generally expected to be the
following quarter.

For additional information on our collaboration arrangements with Genentech,
including information regarding the pre-tax profit-sharing formula and its
impact on future revenue from anti-CD20 therapeutic programs, please read
Note 18, Collaborative and Other Relationships, to our consolidated financial
statements included in our 2021 Form 10-K.

Other Revenue

Other revenue is summarized as follows:



                                                                                  For the Three Months Ended March 31,
(In millions, except percentages)                            2022                                 2021                      % Change            $

Change


Revenue from collaborative and other
relationships                                  $       8.0              12.1  %       $  3.9                4.2  %              105.1  %       $

4.1


Other royalty and corporate revenue                   58.1              87.9            89.4               95.8                 (35.0)            (31.3)
Total other revenue                            $      66.1             100.0  %       $ 93.3              100.0  %              (29.2) %       $  (27.2)

Revenue from Collaborative and Other Relationships

Revenue from collaborative and other relationships primarily includes royalty revenue on biosimilar products from Samsung Bioepis.

For additional information on our collaborative arrangements with Samsung Bioepis, please read Note 16, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

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Other Royalty and Corporate Revenue
[[Image Removed: biib-20220331_g9.jpg]]

We receive royalties from net sales on products related to patents that we have
out-licensed and we record other corporate revenue primarily from amounts earned
under contract manufacturing agreements.

For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in other royalty and corporate revenue was primarily due to lower
contract manufacturing revenue related to timing of batch releases.

Reserves for Discounts and Allowances

Revenue from product sales is recorded net of reserves established for applicable discounts and allowances, including those associated with the implementation of pricing actions in certain international markets where we operate.



These reserves are based on estimates of the amounts earned or to be claimed on
the related sales and are classified as reductions of accounts receivable (if
the amount is payable to our customer) or a liability (if the amount is payable
to a party other than our customer). These estimates reflect our historical
experience, current contractual and statutory requirements, specific known
market events and trends, industry data and forecasted customer buying and
payment patterns. Actual amounts may ultimately differ from our estimates. If
actual results vary, we adjust these estimates, which could have an effect on
earnings in the period of adjustment.

Reserves for discounts, contractual adjustments and returns that reduced gross
product revenue are summarized as follows:
[[Image Removed: biib-20220331_g10.jpg]]

For the three months ended March 31, 2022, reserves for discounts and allowances as a percentage of gross product revenue was 27.0% compared to 29.0% in the prior year comparative period.

Discounts

Discounts include trade term discounts and wholesaler incentives.

For the three months ended March 31, 2022, compared to the same period in 2021, the decrease in discounts was primarily driven by a decrease in gross sales.

Contractual Adjustments

Contractual adjustments primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, co-payment (copay) assistance, Veterans Administration, 340B discounts, specialty pharmacy program fees and other government rebates or applicable allowances.



For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in contractual adjustments was primarily driven by lower TECFIDERA
sales in the U.S., resulting in lower pharmacy rebates, co-pay assistance and
managed care rebates, as well as lower Medicaid rebates in the
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U.S. driven by a favorable change in estimates for VUMERITY.

Returns

Product return reserves are established for returns made by wholesalers. In accordance with contractual terms, wholesalers are permitted to return product for reasons such as damaged or expired product. The majority of wholesaler returns are due to product expiration. Provisions for product returns are recognized in the period the related revenue is recognized, resulting in a reduction to product sales.

For the three months ended March 31, 2022, compared to the same period in 2021, return reserves were relatively consistent.

For additional information on our revenue reserves, please read Note 3, Revenue, to our condensed consolidated financial statements included in this report.

Cost and Expense

A summary of total cost and expense is as follows:



                                                                               For the Three Months Ended March 31,
(In millions, except percentages)                               2022                  2021               % Change              $ Change
Cost of sales, excluding amortization and
impairment of acquired intangible assets                  $        753.9          $   478.1                    57.7  %       $   275.8
Research and development                                           551.7              514.2                     7.3               37.5
Selling, general and administrative                                634.9              595.0                     6.7               39.9

Amortization and impairment of acquired intangible assets

                                                              66.9               98.1                   (31.8)             (31.2)
Collaboration profit (loss) sharing                               (117.3)              68.5                  (271.2)            (185.8)

(Gain) loss on fair value remeasurement of
contingent consideration                                            (7.1)             (33.8)                  (79.0)              26.7

Restructuring charges                                               38.1                  -                         nm            38.1
Total cost and expense                                    $      1,921.1          $ 1,720.1                    11.7  %       $   201.0




nm Not meaningful

Cost of Sales, Excluding Amortization and Impairment of Acquired Intangible
Assets
[[Image Removed: biib-20220331_g11.jpg]]
Product Cost of Sales

For the three months ended March 31, 2022, compared to the same period in 2021, the increase in product cost of sales was primarily due to the write-off of ADUHELM inventory and idle capacity charges.



During the first quarter of 2022 we recorded approximately $275.0 million of
gross charges associated with inventory and purchase commitments in excess of
forecasted demand related to ADUHELM, as well as approximately $45.0 million of
gross idle capacity charges, which were recognized in cost of sales within our
condensed consolidated statements of income. We have recognized approximately
$160.0 million related to Eisai's 45.0% share of these charges in collaboration
profit (loss) sharing within our condensed consolidated statements of income.

For the three months ended March 31, 2022, compared to the same period in 2021, royalty cost of sales remained flat.

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Research and Development
[[Image Removed: biib-20220331_g12.jpg]]
[[Image Removed: biib-20220331_g13.jpg]]

We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development programs and business development opportunities.



A significant amount of our research and development costs consists of indirect
costs incurred in support of overall research and development activities and
non-specific programs, including activities that benefit multiple programs, such
as
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management costs, as well as depreciation, information technology and facility-based expenses. These costs are considered other research and development costs in the table above and are not allocated to a specific program or stage.



Research and development expense incurred in support of our marketed products
includes costs associated with product lifecycle management activities
including, if applicable, costs associated with the development of new
indications for existing products. Late stage programs are programs in Phase 3
development or in registration stage. Early stage programs are programs in Phase
1 or Phase 2 development. Research and discovery represents costs incurred to
support our discovery research and translational science efforts. Costs are
reflected in the development stage based upon the program status when incurred.
Therefore, the same program could be reflected in different development stages
in the same year. For several of our programs, the research and development
activities are part of our collaborative and other relationships. Our costs
reflect our share of the total costs incurred.

For the three months ended March 31, 2022, compared to the same period in 2021,
the increase in research and development expense was primarily due to milestone
payments, an increase in spending related to lecanemab, the advancement of
BIIB059 (anti-BDCA2) for the potential treatment of systemic lupus erytheatosus
(SLE), the development of mosunetuzumab, a late-stage bispecific antibody in
development for B-cell non-Hodgkin's lymphoma and other therapeutic areas, the
development of BIIB124 (SAGE-324) for the potential treatment of essential
tremor, which we are developing in collaboration with Sage Therapeutics, Inc.
(Sage), the development of BIIB122 (DNL151) for the potential treatment of
Parkinson's disease, which we are developing in collaboration with Denali
Therapeutics Inc. (Denali), and the development of BIIB135 (orelabrutinib) for
the potential treatment of MS.

In 2021 we recorded upfront payments related to our new collaborations as part
of research and development expense. Excluding upfront payments, we expect our
core research and development expense in 2022 to be consistent with 2021 as we
continue to invest in our pipeline. We intend to continue committing significant
resources to targeted research and development opportunities where there is a
significant unmet need and where a drug candidate has the potential to be highly
differentiated.

Early Stage Programs

For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in spending related to our early stage programs was primarily due
to a decrease in costs associated with:

•the discontinuation of BIIB054 (cinpanemab) in Parkinson's disease;

•the discontinuation of gosuranemab (BIIB092) in Alzheimer's disease;

•the discontinuation of BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa; and

•the advancement of BIIB059 for the potential treatment of SLE into late stage.

These decreases were partially offset by an increase in costs associated with:

•an increase in spending in the development of BIIB124 for the potential treatment of essential tremor;

•an increase in spending in the development of BIIB122 for the potential treatment of Parkinson's disease; and

•an increase in spending in the development of BIIB135 for the potential treatment of MS.

Late Stage Programs



For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in spending associated with our late stage programs was primarily
due to:

•the advancement of ADUHELM from late stage to marketed upon the accelerated approval of ADUHELM in the U.S.; and

•the discontinuation of BIIB111 (timrepigene emparvovec) in choroideremia.

These decreases were partially offset by an increase in costs associated with:

•the advancement of BIIB059 for the potential treatment of SLE into late stage;

•an increase in spending related to lecanemab; and



•an increase in spending related to mosunetuzumab, a late-stage bispecific
antibody in development for B-cell non-Hodgkin's lymphoma and other therapeutic
areas.
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Marketed Programs



For the three months ended March 31, 2022, compared to the same period in 2021,
the increase in spending associated with our marketed programs was primarily due
to an increase in costs associated with:

•the advancement of ADUHELM from late stage to marketed upon the accelerated approval of ADUHELM in the U.S.



In March 2019 Eisai initiated a global Phase 3 trial for the development of
lecanemab in early Alzheimer's disease. Under our collaboration arrangement,
Eisai serves as the lead of lecanemab development and regulatory submissions
globally with both companies co-commercializing and co-promoting the product,
and Eisai having final decision-making authority. All costs, including research,
development, sales and marketing expense, are shared equally between us and
Eisai.



Selling, General and Administrative
[[Image Removed: biib-20220331_g14.jpg]]
For the three months ended March 31, 2022, compared to the same period in 2021,
the 6.7% increase in selling, general and administrative expense was primarily
due to gross ADUHELM commercialization expense of approximately $80.0 million,
partially offset by cost-reduction measures realized during the first quarter of
2022.

As a result of the final NCD we will substantially eliminate our commercial
infrastructure supporting ADUHELM, retaining minimal resources to manage patient
access programs, including a continued free drug program for patients currently
on treatment in the U.S.

Beginning in the second quarter of 2021 reimbursement from Eisai for its share
of U.S. ADUHELM selling, general and administrative expense is recognized in
collaboration profit (loss) sharing in our condensed consolidated statements of
income.

Amortization and Impairment of Acquired Intangible Assets [[Image Removed: biib-20220331_g15.jpg]]



Our amortization expense is based on the economic consumption and impairment of
intangible assets. Our most significant amortizable intangible assets are
related to our TYSABRI, AVONEX, SPINRAZA, VUMERITY and TECFIDERA (rest of world)
products and other programs acquired through business combinations.

For the three months ended March 31, 2022, compared to the same period in March
31, 2021, the decrease in amortization and impairment of acquired intangible
assets was primarily related to a $44.3 million impairment charge recorded
during the first quarter of 2021 related to vixotrigine (BIIB074) for the
potential treatment of trigeminal neuralgia (TGN). For the three months ended
March 31, 2022, we had no impairment charges.

We monitor events and expectations regarding product performance. If new
information indicates that the assumptions underlying our most recent analysis
are substantially different than those utilized in our current estimates, our
analysis would be updated and may result in a significant change in the
anticipated lifetime revenue of the relevant products. The occurrence of an
adverse event could substantially increase the amount of amortization expense
related to our acquired intangible assets as compared to previous periods or our
current expectations, which may result in a significant negative impact on our
future results of operations.
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IPR&D Related to Business Combinations



IPR&D represents the fair value assigned to research and development assets that
we acquired as part of a business combination and had not yet reached
technological feasibility at the date of acquisition. We review amounts
capitalized as acquired IPR&D for impairment annually, as of October 31, and
whenever events or changes in circumstances indicate to us that the carrying
value of the assets might not be recoverable.

Overall, the value of our acquired IPR&D assets is dependent upon several
variables, including estimates of future revenue and the effects of competition,
our ability to secure sufficient pricing in a competitive market, our ability to
confirm safety and efficacy based on data from clinical trials and regulatory
feedback, the level of anticipated development costs and the probability and
timing of successfully advancing a particular research program from one clinical
trial phase to the next. We are continually reevaluating our estimates
concerning these and other variables, including our life cycle management
strategies, research and development priorities and development risk, changes in
program and portfolio economics and related impact of foreign currency exchange
rates and economic trends and evaluating industry and company data regarding the
productivity of clinical research and the development process. Changes in our
estimates may result in a significant change to our valuation of our IPR&D
assets.

Vixotrigine



In the periods since we acquired vixotrigine, there have been numerous delays in
the initiation of Phase 3 studies for the potential treatment of TGN and for the
potential treatment of diabetic painful neuropathy (DPN), another form of
neuropathic pain. We have engaged with the FDA regarding the design of the Phase
3 studies of vixotrigine for the potential treatment of TGN and DPN and are now
performing an additional clinical trial of vixotrigine, which is expected to be
completed by the end of 2022.

The performance of this additional clinical trial delayed the initiation of the
Phase 3 studies of vixotrigine for the potential treatment of TGN, and, as a
result, we recognized an impairment charge of $44.3 million related to
vixotrigine for the potential treatment of TGN during the first quarter of 2021.

As of March 31, 2022, the carrying value associated with the remaining IPR&D asset for DPN was $129.1 million and the fair value of this asset was not significantly in excess of its carrying value. Upon the completion of the additional clinical trial we will reevaluate the carrying value of the program.



For additional information on the amortization and impairment of our acquired
intangible assets, please read Note 5, Intangible Assets and Goodwill, to our
condensed consolidated financial statements included in this report.

Collaboration Profit (Loss) Sharing
[[Image Removed: biib-20220331_g16.jpg]]

Collaboration profit (loss) sharing primarily includes Samsung Bioepis' 50.0%
share of the profit or loss related to our biosimilars commercial agreement with
Samsung Bioepis and, beginning in the second quarter of 2021, Eisai's 45.0%
share of income and expense in the U.S. related to the ADUHELM Collaboration
Agreement.

For the three months ended March 31, 2022, we recognized net profit-sharing
expense of $64.4 million to reflect Samsung Bioepis' 50.0% sharing of the net
collaboration profits compared to a net profit-sharing expense of $68.5 million
in the prior year comparative period.

For the three months ended March 31, 2022, we recognized a net reduction to our operating expense of $181.7 million to reflect Eisai's 45.0% share of net collaboration losses in the U.S.

For additional information on our collaboration arrangements with Samsung Bioepis and Eisai, please read Note 16, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.

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(Gain) Loss on Fair Value Remeasurement of Contingent Consideration [[Image Removed: biib-20220331_g17.jpg]]



Consideration payable for certain of our business combinations includes future
payments that are contingent upon the occurrence of a particular event or
events. We record an obligation for such contingent consideration payments at
fair value on the acquisition date. We then revalue our contingent consideration
obligations each reporting period. Changes in the fair value of our contingent
consideration obligations, other than changes due to payments, are recognized as
a (gain) loss on fair value remeasurement of contingent consideration in our
condensed consolidated statements of income.

For the three months ended March 31, 2022, changes in the fair value of our contingent consideration obligations were primarily due to an increase in discount rates used to revalue these obligations and delays in the expected timing of the achievement of certain remaining developmental milestones related to our vixotrigine programs.



Restructuring Charges
[[Image Removed: biib-20220331_g18.jpg]]

2022 Cost Saving Initiatives



In December 2021 and May 2022 we announced our plans to implement a series of
cost-reduction measures during 2022. These savings are expected to be achieved
through a number of initiatives, including reductions to our workforce,
primarily within our global Alzheimer's infrastructure, the consolidation of
certain real estate locations and operating efficiency gains across our selling,
general and administrative and research and development functions.

Under these initiatives, we expect to incur restructuring charges ranging from
approximately $100.0 million to $150.0 million. These amounts are primarily
related to severance and are expected to be substantially incurred and paid by
the end of 2022.

For the three months ended March 31, 2022, we recognized $27.7 million of
employee related costs, primarily related to severance. These costs were
recorded in restructuring charges in our condensed consolidated statements of
income. Our restructuring reserve is included in accrued expense and other in
our condensed consolidated balance sheets.

Following an evaluation of our current capacity needs, in March 2022 we ceased
using a patient services office space in Durham, North Carolina. We are
marketing the space for sublease. Our decision to cease using the facility
resulted in the immediate expense of certain leasehold improvements and other
assets at this facility, which we do not believe can be adequately recovered in
a sublease. As a result, for the three months ended March 31, 2022, we
recognized approximately $10.4 million of accelerated depreciation expense,
which was recorded in
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restructuring charges in our condensed consolidated statements of income.



The following table summarizes the charges and spending related to our 2022 cost
saving initiatives for the three months ended March 31, 2022:
(In millions)                     Workforce Reduction       Total
Restructuring reserve as of
December 31, 2021                $                  -      $    -
Expense                                          27.7        27.7
Payment                                          (6.2)       (6.2)

Restructuring reserve as of
March 31, 2022                   $               21.5      $ 21.5


Other Income (Expense), Net
[[Image Removed: biib-20220331_g19.jpg]]

For the three months ended March 31, 2022, compared to the same period in 2021, the change in other income (expense), net primarily reflects net unrealized losses on our holdings in equity securities.



For the three months ended March 31, 2022, net unrealized losses and realized
gains on our holdings in equity securities were approximately $190.9 million and
$0.2 million, respectively, compared to net unrealized losses and realized gains
of approximately $442.3 million and $6.2 million, respectively, in the prior
year comparative period. The net unrealized losses recognized during the three
months ended March 31, 2022, primarily reflect decreases in the aggregate fair
value of our investments in Denali, Sage and Sangamo Therapeutics, Inc.
(Sangamo) common stock of approximately $205.5 million.

Income Tax Provision
[[Image Removed: biib-20220331_g20.jpg]]

Our effective tax rate fluctuates from year to year due to the global nature of
our operations. The factors that most significantly impact our effective tax
rate include changes in tax laws, variability in the allocation of our taxable
earnings among multiple jurisdictions, the amount and characterization of our
research and development expense, the levels of certain deductions and credits,
acquisitions and licensing transactions.

During the second quarter of 2021 we recorded a net deferred tax asset in Switzerland of approximately $490.0 million on Neurimmune SubOne AG's (Neurimmune) tax basis in ADUHELM, the realization of which is dependent on future sales of ADUHELM. During the fourth quarter of 2021, due to reduced future expected revenue associated with ADUHELM, we recorded a valuation allowance of approximately $390.0 million.



During the first quarter of 2022, upon issuance of the final NCD related to
ADUHELM, we recorded an additional valuation allowance of approximately
$85.0 million to reduce the net value of this deferred tax asset to zero. These
adjustments to our deferred tax assets and their valuation allowances are each
recorded with an equal and offsetting amount assigned to net income (loss)
attributable to noncontrolling interests, net of tax in our condensed
consolidated statements of income, resulting in a zero net impact to net income
attributable to Biogen Inc.

For the three months ended March 31, 2022, compared to the same period in 2021,
the increase in our effective tax rate was primarily due to a deferred tax
expense related to a valuation allowance, as discussed above, and the non-cash
tax effects of changes in the value of our equity investments. The tax effects
of this change in value of our equity
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investments were recorded discretely, since changes in value of equity investments cannot be forecasted.

For additional information on our collaboration arrangement with Neurimmune, please read Note 17, Investments in Variable Interest Entities, to these condensed consolidated financial statements.

For additional information on our income taxes please read Note 14, Income Taxes, to our condensed consolidated financial statements included in this report.



Equity in (Income) Loss of Investee, Net of Tax
[[Image Removed: biib-20220331_g21.jpg]]
In February 2012 we entered into a joint venture agreement with Samsung
BioLogics establishing an entity, Samsung Bioepis, to develop, manufacture and
market biosimilar products. As of March 31, 2022, our ownership percentage was
approximately 49.9%.

We recognize our share of the results of operations related to our investment in
Samsung Bioepis under the equity method of accounting one quarter in arrears
when the results of the entity become available, which is reflected as equity in
(income) loss of investee, net of tax in our condensed consolidated statements
of income. We recognize amortization on certain basis differences resulting from
our November 2018 investment.

For the three months ended March 31, 2022, we recognized net losses on our investment of $3.3 million, reflecting our share of Samsung Bioepis' operating profits, net of tax totaling $4.0 million offset by amortization of basis differences totaling $7.3 million.

For the three months ended March 31, 2021, we recognized net losses on our investment of $18.2

million, reflecting our share of Samsung Bioepis' operating losses, net of tax totaling $11.0 million and amortization of basis differences totaling $7.2 million.



Noncontrolling Interests, Net of Tax
[[Image Removed: biib-20220331_g22.jpg]]
Our condensed consolidated financial statements include the financial results of
our variable interest entity, Neurimmune, as we determined that we are the
primary beneficiary.

For the three months ended March 31, 2022, compared to the same period in 2021,
the change in net income (loss) attributable to noncontrolling interests, net of
tax, was primarily due to a valuation allowance related to a prior year deferred
tax benefit associated with the accelerated approval of ADUHELM by the FDA in
the U.S.

In the first quarter of 2022 we recorded a valuation allowance of approximately
$85.0 million related to this deferred tax asset. There is an equal and
offsetting amount assigned to net income (loss) attributable to noncontrolling
interests, net of tax in our condensed consolidated statements of income,
resulting in a zero net impact to net income attributable to Biogen Inc.

For additional information on our collaboration agreement with Neurimmune, please read Note 17, Investments in Variable Interest Entities, to our condensed consolidated financial statements included in this report.

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FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Our financial condition is summarized as follows:


                                                        As of March 31,        As of December
(In millions, except percentages)                            2022                 31, 2021               Change %
Financial assets:
Cash and cash equivalents                               $    1,749.3          $     2,261.4                   (22.6) %
Marketable securities - current                              2,002.4                1,541.1                    29.9
Marketable securities - non-current                          1,001.6                  892.0                    12.3
Total cash, cash equivalents and marketable
securities                                              $    4,753.3          $     4,694.5                     1.3  %

Borrowings:


Current portion of notes payable                        $      999.5          $       999.1                       -  %
Notes payable                                                6,275.7                6,274.0                       -
Total borrowings                                        $    7,275.2          $     7,273.1                       -  %
Working capital:
Current assets                                          $    7,915.9          $     7,856.5                     0.8  %
Current liabilities                                         (3,946.6)              (4,298.2)                   (8.2)
Total working capital                                   $    3,969.3          $     3,558.3                    11.6  %

For the three months ended March 31, 2022, certain significant cash flows were as follows:

•$161.8 million in net cash flow provided by operating activities; and

•$57.9 million used for purchases of property, plant and equipment.

Overview



We have historically financed and expect to continue to fund our operating and
capital expenditures primarily through cash flow earned through our operations
as well as our existing cash resources. We believe generic competition for
TECFIDERA in the U.S. will continue to reduce our cash flow from operations in
2022 and will have a significant adverse impact on our future cash flow from
operations. Additionally, in 2022 we will repay or refinance $1.0 billion
related to our 3.625% Senior Notes due September 15, 2022.

In March 2021 we announced our plans to build a new gene therapy manufacturing
facility in RTP, North Carolina to support our gene therapy pipeline across
multiple therapeutic areas. The new facility is expected to be operational by
the end of 2023, with an estimated total investment of approximately
$200.0 million. Construction for this new facility began during the fourth
quarter of 2021.

We believe that our existing funds, when combined with cash generated from
operations and our access to additional financing resources, if needed, are
sufficient to satisfy our operating, working capital, strategic alliance,
milestone payment, capital expenditure and debt service requirements for the
foreseeable future. In addition, we may choose to opportunistically return cash
to shareholders and pursue other business initiatives, including acquisition and
licensing activities. We may, from time to time,

also seek additional funding through a combination of new collaborative agreements, strategic alliances and additional equity and debt financings or from other sources should we identify a significant new opportunity.



For additional information on certain risks that could negatively impact our
financial position or future results of operations, please read Item 1A. Risk
Factors and Item 3. Quantitative and Qualitative Disclosures About Market Risk
included in this report.

Cash, Cash Equivalents and Marketable Securities



Until required for another use in our business, we typically invest our cash
reserves in bank deposits, certificates of deposit, commercial paper, corporate
notes, U.S. and foreign government instruments, overnight reverse repurchase
agreements and other interest-bearing marketable debt instruments in accordance
with our investment policy. It is our policy to mitigate credit risk in our cash
reserves and marketable securities by maintaining a well-diversified portfolio
that limits the amount of exposure as to institution, maturity and investment
type.

As of March 31, 2022, we had cash, cash equivalents and marketable securities
totaling approximately $4.8 billion compared to approximately $4.7 billion as of
December 31, 2021. The change in cash, cash equivalents and marketable
securities at March 31, 2022, from December 31, 2021, was primarily due to net
cash flow provided by operating activities, partially offset by cash used for
capital expenditures.

Investments and other assets in our condensed consolidated balance sheets as of March 31, 2022 and December 31, 2021, include the carrying value of our investment in Samsung Bioepis of $586.4 million

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and $599.9 million, respectively. In January 2022 we entered into an agreement
to sell to Samsung BioLogics our equity in Samsung Bioepis, which was completed
on April 20, 2022. Under the terms of the transaction, we received approximately
$1.0 billion in cash at closing and will receive approximately $1.3 billion to
be deferred over two payments of $812.5 million due at the first anniversary and
$437.5 million due at the second anniversary of the closing of the transaction.
We are also eligible to receive up to an additional $50.0 million upon the
achievement of certain commercial milestones.

The following table summarizes the fair value of our significant common stock
investments in the following:
(In millions)         March 31, 2022      December 31, 2021
Sangamo              $        138.6      $            173.7
Denali                        428.2                   550.7
Sage                          184.0                   231.9
Ionis                         106.5                    87.5
                     $        857.3      $          1,043.8


For additional information on our collaboration arrangements with Samsung
Bioepis, Sangamo, Denali and Sage, please read Note 16, Collaborative and Other
Relationships, to our condensed consolidated financial statements included in
this report.

For additional information on our collaboration arrangements with Ionis, please read Note 18, Collaborative and Other Relationships, to our consolidated financial statements included in our 2021 Form 10-K.

Borrowings

In February 2021 we completed our Exchange Offer, consisting of the following:

•$624.6 million aggregate principal amount of our 2045 Senior Notes was exchanged for $700.7 million aggregate principal amount of our 2051 Senior Notes and approximately $151.8 million of aggregate cash payments; and



•$8.9 million aggregate principal amount of our 2045 Senior Notes was redeemed
for approximately $12.1 million of aggregate cash payments, excluding accrued
and unpaid interest.

In April 2020 we issued senior unsecured notes for an aggregate principal amount of $3.0 billion (2020 Senior Notes), consisting of the following:

•$1.5 billion aggregate principal amount of 2.25% Senior Notes due May 1, 2030; and

•$1.5 billion aggregate principal amount of 3.15% Senior Notes due May 1, 2050.

The following is a summary of our currently outstanding senior unsecured notes issued in 2015 (2015 Senior Notes):

•$1.0 billion aggregate principal amount of 3.625% Senior Notes due September 15, 2022;

•$1.75 billion aggregate principal amount of 4.05% Senior Notes due September 15, 2025; and

•$1.12 billion aggregate principal amount of 5.20% Senior Notes due September 15, 2045.

Our 2020 Senior Notes and our 2015 Senior Notes were issued at a discount, which are amortized as additional interest expense over the period from issuance through maturity.



For a summary of the fair and carrying values of our outstanding borrowings as
of March 31, 2022 and December 31, 2021, please read Note 6, Fair Value
Measurements, to our condensed consolidated financial statements included in
this report.

Credit Facility

In January 2020 we entered into a $1.0 billion, five-year senior unsecured
revolving credit facility under which we are permitted to draw funds for working
capital and general corporate purposes. The terms of the revolving credit
facility include a financial covenant that requires us not to exceed a maximum
consolidated leverage ratio. As of March 31, 2022 and December 31, 2021, we had
no outstanding borrowings and were in compliance with all covenants under this
facility.

Working Capital

Working capital is defined as current assets less current liabilities. Working
capital was $4.0 billion and $3.6 billion as of March 31, 2022 and December 31,
2021, respectively. The change in working capital reflects an increase in total
current assets of approximately $59.4 million and a decrease in total current
liabilities of approximately $351.6 million.

The increase in total current assets was primarily driven by an increase in our
product accounts receivable and other receivable balances, partially offset by
the write-off of inventory related to ADUHELM.

The decrease in current liabilities was primarily due to a reduction in accounts
payable and accrued expense and other, which was primarily related to a decrease
in the accrual for employee compensation, as well as approximately $66.0 million
of upfront and milestone payments made in 2022, which were
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accrued as of December 31, 2021, partially offset by an increase in income taxes payable.



Share Repurchase Programs

In October 2020 our Board of Directors authorized a program to repurchase up to
$5.0 billion of our common stock (2020 Share Repurchase Program). Our 2020 Share
Repurchase Program does not have an expiration date. All share repurchases under
our 2020 Share Repurchase Program will be

retired. Under our 2020 Share Repurchase Program, we repurchased and retired
approximately 2.2 million shares of our common stock at a cost of approximately
$600.0 million during the three months ended March 31, 2021. There were no share
repurchases of our common stock during the three months ended March 31, 2022.
Approximately $2.8 billion remained available under our 2020 Share Repurchase
Program as of March 31, 2022.

Cash Flow

The following table summarizes our cash flow activity:


                                                                         For the Three Months Ended March 31,
(In millions, except percentages)                                 2022                 2021                 % Change
Net cash flow provided by (used in) operating
activities                                                   $      161.8          $    769.0                     (79.0) %
Net cash flow provided by (used in) investing
activities                                                         (648.0)              (64.7)                    901.5
Net cash flow provided by (used in) financing
activities                                                          (16.5)             (785.0)                    (97.9)


Operating Activities

Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. We expect cash provided from operating activities will continue to be our primary source of funds to finance operating needs and capital expenditures for the foreseeable future.

Operating cash flow is derived by adjusting our net income for:



•non-cash operating items such as depreciation and amortization, impairment
charges, unrealized gain (loss) on strategic investments, acquired IPR&D and
share-based compensation;

•changes in operating assets and liabilities, which reflect timing differences
between the receipt and payment of cash associated with transactions and when
they are recognized in results of operations; and

•changes in the fair value of contingent payments associated with our acquisitions of businesses and payments related to collaborations.



For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in net cash flow provided by operating activities was primarily due
to lower net income as well as timing of payments, which includes approximately
$69.0 million of upfront and milestone payments made in 2022.

Investing Activities



For the three months ended March 31, 2022, compared to the same period in 2021,
the increase in net cash flow used in investing activities was primarily due to
an increase in net purchases of marketable securities in the current period.

Financing Activities



For the three months ended March 31, 2022, compared to the same period in 2021,
the decrease in net cash flow used in financing activities was primarily due to
no share repurchase activity in 2022 compared to approximately $600.0 million of
shares repurchased in the prior year comparative period. Additionally, we
executed our Exchange Offer in the first quarter of 2021, which resulted in net
cash outflows of $169.3 million.

Contractual Obligations and Off-Balance Sheet Arrangements

Contractual Obligations



Our contractual obligations primarily consist of our obligations under
non-cancellable operating leases, long-term debt obligations and defined benefit
and other purchase obligations, excluding amounts related to uncertain tax
positions, funding commitments, contingent development, regulatory and
commercial milestone payments, contingent payments and contingent consideration
related to our business combinations, as described below.

There have been no material changes in our contractual obligations since December 31, 2021.



Royalty Payments

TYSABRI

We are obligated to make contingent payments of 18.0% on annual worldwide net
sales of TYSABRI up to $2.0 billion and 25.0% on annual worldwide net sales of
TYSABRI that exceed $2.0 billion. Royalty payments are recognized as cost of
sales in our condensed consolidated statements of income.
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SPINRAZA

We make royalty payments on annual worldwide net sales of SPINRAZA using a tiered royalty rate between 11.0% and 15.0%, which are recognized as cost of sales in our condensed consolidated statements of income.

VUMERITY



In October 2019 the FDA approved VUMERITY for the treatment of RMS. During the
fourth quarter of 2021 VUMERITY was approved for the treatment of RRMS in the
E.U., Switzerland and the U.K. Under our agreement with Alkermes Pharma Ireland
Limited, a subsidiary of Alkermes plc (Alkermes), we make royalty payments to
Alkermes on worldwide net sales of VUMERITY using a royalty rate of 15.0%, which
are recorded as cost of sales in our condensed consolidated statements of
income.

In October 2019 we entered into a new supply agreement and amended our license
and collaboration agreement with Alkermes. We have elected to initiate a
technology transfer and, following a transition period, to manufacture VUMERITY
or have VUMERITY manufactured by a third party we have engaged in exchange for
paying an increased royalty rate to Alkermes on any portion of future worldwide
net sales of VUMERITY that is manufactured by us or our designee. For additional
information on our collaboration arrangement with Alkermes, please read Note 18,
Collaborative and Other Relationships, to our consolidated financial statements
included in our 2021 Form 10-K.

Contingent Consideration related to Business Combinations

In connection with our acquisition of Convergence Pharmaceuticals Holdings Ltd. we agreed to make additional payments based upon the achievement of certain milestone events.

We recognized the contingent consideration liabilities associated with this acquisition at their fair value on the acquisition date and revalue these obligations each reporting period. We may pay up to approximately $400.0 million in remaining milestones related to this acquisition.

Contingent Development, Regulatory and Commercial Milestone Payments



Based on our development plans as of March 31, 2022, we could trigger potential
future milestone payments to third parties of up to approximately $9.2 billion,
including approximately $1.9 billion in development milestones, approximately
$900.0 million in regulatory milestones and approximately $6.4 billion in
commercial milestones, as part of our various collaborations, including
licensing and

development programs. Payments under these agreements generally become due and
payable upon achievement of certain development, regulatory or commercial
milestones. Because the achievement of these milestones was not considered
probable as of March 31, 2022, such contingencies have not been recorded in our
financial statements. Amounts related to contingent milestone payments are not
considered contractual obligations as they are contingent on the successful
achievement of certain development, regulatory or commercial milestones.

If certain clinical and commercial milestones are met, we may pay up to
$49.8 million in milestones in 2022 under our current agreements. Additionally,
if aducanumab receives regulatory approval in the jurisdictions where we have
submitted filings, we may pay additional milestones to Neurimmune, including
$50.0 million if launched in Japan. Milestones payable to Neurimmune are shared
expenses under the ADUHELM Collaboration Agreement.



For additional information on our collaboration arrangement with Neurimmune,
please read Note 17, Investments in Variable Interest Entities, to our condensed
consolidated financial statements included in this report.

Other Funding Commitments



As of March 31, 2022, we have several ongoing clinical studies in various
clinical trial stages. Our most significant clinical trial expenditures are to
contract research organizations (CROs). The contracts with CROs are generally
cancellable, with notice, at our option. We recorded accrued expense of
approximately $26.9 million in our condensed consolidated balance sheet for
expenditures incurred by CROs as of March 31, 2022. We have approximately $881.4
million in cancellable future commitments based on existing CRO contracts as of
March 31, 2022.

As part of the sale of our Hillerød, Denmark manufacturing operations to
FUJIFILM Corporation (FUJIFILM), we provided FUJIFILM with certain minimum batch
production commitment guarantees. There is a risk that the minimum contractual
batch production commitments will not be met. Based upon current estimates we do
not expect to incur an adverse commitment obligation associated with such
guarantees. We developed this estimate using a probability-weighted estimate of
future manufacturing activity and may further adjust this estimate based upon
changes in business conditions, which may
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result in the increase or reduction of this adverse commitment obligation in subsequent periods.

For additional information on the divestiture of our Hillerød, Denmark manufacturing operations, please read Note 3, Divestitures, to our consolidated financial statements included in our 2021 Form 10-K.

Tax Related Obligations



We exclude liabilities pertaining to uncertain tax positions from our summary of
contractual obligations as we cannot make a reliable estimate of the period of
cash settlement with the respective taxing authorities. As of March 31, 2022, we
have approximately $105.6 million of liabilities associated with uncertain tax
positions.

As of March 31, 2022 and December 31, 2021, we have accrued income tax
liabilities of approximately $633.0 million under a one-time mandatory deemed
repatriation tax on accumulated foreign subsidiaries' previously untaxed foreign
earnings (the Transition Toll Tax). Of the amounts accrued as of March 31, 2022,
approximately $72.7 million is expected to be paid within one year. The
Transition Toll Tax will be paid in installments over an eight-year period,
which started in 2018, and will not accrue interest.

Other Off-Balance Sheet Arrangements



We do not have any relationships with entities often referred to as structured
finance or special purpose entities that were established for the purpose of
facilitating off-balance sheet arrangements. As such, we are not exposed to any
financing, liquidity, market or credit risk that could arise if we had engaged
in such relationships. We consolidate variable interest entities if we are the
primary beneficiary.

New Accounting Standards

For a discussion of new accounting standards please read Note 1, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included in this report.

Critical Accounting Estimates



The preparation of our condensed consolidated financial statements, which have
been prepared in accordance with accounting principles generally accepted in the
U.S., requires us to make estimates, judgments and assumptions that may affect
the reported amounts of assets, liabilities, equity, revenue and expense and
related disclosure of contingent assets and liabilities. On an ongoing basis we
evaluate our estimates, judgments and assumptions. We base our estimates on
historical

experience and on various other assumptions that we believe are reasonable, the
results of which form the basis for making judgments about the carrying values
of assets, liabilities and equity and the amount of revenue and expense. Actual
results may differ from these estimates.

For a discussion of our critical accounting estimates, please read Part II,
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operations in our 2021 Form 10-K. There have been no material changes to our
critical accounting estimates since our 2021 Form 10-K.

Market Closed - Nasdaq Other stock markets 04:00:00 2024-04-25 pm EDT			5-day change	1st Jan Change
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Apr. 25	Goldman Sachs Adjusts Biogen Price Target to $340 From $393	MT
Apr. 25	Canaccord Genuity Adjusts Price Target on Biogen to $308 From $305	MT

Goldman Sachs Adjusts Biogen Price Target to $340 From $393	Apr. 25	MT
Canaccord Genuity Adjusts Price Target on Biogen to $308 From $305	Apr. 25	MT
Barclays Adjusts Price Target on Biogen to $200 From $215	Apr. 25	MT
HC Wainwright Adjusts Biogen's Price Target to $300 From $325	Apr. 25	MT
Wedbush Adjusts Price Target on Biogen to $215 From $213	Apr. 25	MT
Health Care Down Amid Mixed Earnings -- Health Care Roundup	Apr. 24	DJ
Sector Update: Health Care Stocks Slipping Late Afternoon	Apr. 24	MT
News Highlights : Top Company News of the Day - Wednesday at 3 PM ET	Apr. 24	DJ
Wall St edges lower as rising yields overshadow upbeat corporate results	Apr. 24	RE
Morgan Stanley Cuts Biogen's Price Target to $331 From $339	Apr. 24	MT
Sector Update: Health Care Stocks Softer Wednesday Afternoon	Apr. 24	MT
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Piper Sandler Raises Biogen's Price Target to $335 From $325	Apr. 24	MT
RBC Lowers Biogen's Price Target to $317 From $326	Apr. 24	MT
News Highlights : Top Company News of the Day - Wednesday at 1 PM ET	Apr. 24	DJ
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Transcript : Biogen Inc., Q1 2024 Earnings Call, Apr 24, 2024	Apr. 24
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Biogen: 8% increase in quarterly EPS	Apr. 24	CF
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Biogen Inc. Provides Earnings Guidance for the Full Year of 2024	Apr. 24	CI

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