2017 ANNUAL REPORT
`2017 ANNUAL REPORT
`
`PIONEERING THE FUTURE
`PIONEERING THE FUTURE
`OF NEUROSCIENCE
`OFNEUROSCENCE
`
`
`
`..........................................
`
`.............................................................
`
`@
`
`YEARS
`
`“’Biogen.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 1
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`

`

`
`
`1 | 2017 Biogen Annual Report1 | 2017 Biogen Annual Report
`
`About the Cover
`Left: Ankur is Senior Associate Scientist, Neurology Research at Biogen
`Right: Erin is Associate Director, Pharmaceutical Development, Pharmaceutical Operations & Technology (PO&T) and Albert is Principal Scientist, Pharmaceutical
`Development, PO&T at Biogen
`
`About the Graphic Artwork
`The artwork highlighted in the report was submitted by Biogen’s R&D team as part of our annual RAD (Research and Development) Art contest. Each image reflects
`work underway in the lab every day.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 2
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`

`

`2017 Biogen Annual Report | 2
`
`FINANCIAL PERFORMANCE
`FINANCIAL PERFORMANCE
`
`REVENUES
`REVENUES
`$ in millions
`$ in millions
`
`GAAP
`GAAP
`DILUTED
`DILUTED
`EPS
`EPS
`
`NON-GAAP
`NON-GAAP
`DILUTED
`DILUTED
`EPS*
`EPS*
`
`FREE CASH
`FREE CASH
`FLOW*
`FLOW*
`$ in millions
`$ in millions
`
`2013
`2014
`2015
`2016
`2017
`
`2013
`2014
`2015
`2016
`2017
`
`2013
`2014
`2015
`2016
`2017
`
`2013
`2014
`2015
`2016
`2017
`
`$6,932
`$9,703
`$10,764
`$11,499
`$12,274
`
`$7.81
`
`$12.37
`
`$11.921
`
`$15.34
`$16.93
`
`$8.96
`
`$13.83
`$17.01
`
`$20.22
`$21.81
`
`$2,084
`$2,279
`$2,223
`$2,706
`$2,4842
`
`1 “GAAP diluted EPS” for 2017 reflects the impact of The Tax Cuts and Jobs Act of 2017 and higher costs associated
` with our external business development activities, including our agreements with Bristol-Myers Squibb Company, Ionis
` Pharmaceuticals Inc., Neurimmune Subone AG and Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc.
`2 “Free Cash Flow*” for 2017 reflects an increase in capital expenditures related to the construction of our large-scale
` biologics manufacturing facility in Solothurn, Switzerland.
`* “Non-GAAP diluted EPS” and “Free Cash Flow” are Non-GAAP financial measures. A reconciliation of GAAP to
`
` Non-GAAP diluted EPS and Free Cash Flow amounts is set forth on pages 18-20 of this Annual Report.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 3
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`

`

`3 | 2017 Biogen Annual Report
`
` MICHEL VOUNATSOS
`CHIEF EXECUTIVE OFFICER
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 4
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`

`

`2017 Biogen Annual Report | 4
`
` ~ 1b
`
`PEOPLE
`SUFFER FROM
`NEUROLOGICAL
`DISORDERS
`WORLDWIDE
`
` 12
`
`LIFE-CHANGING
`MEDICINES
`
`DEAR FELLOW SHAREHOLDERS:
`I am honored and humbled to write to you as the CEO of Biogen as
`we celebrate our 40th anniversary in 2018. One of the world’s first
`global biotechnology companies, we were founded in 1978 by Charles
`Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
`Walter Gilbert and Phillip Sharp.
`
`OUR FOUNDERS’ guiding principles and leadership in innovative scientific research
`have sustained at Biogen to this day. Over the past decade, we have been devoted to defeating
`devastating neurological diseases. Biogen has established a 20-year foundation in multiple sclerosis
`(MS) treatment and, most recently, pioneered a treatment for spinal muscular atrophy (SMA).
`
`2018 is a remarkable time to lead a company at the forefront of neuroscience. We believe no other
`disease area holds as much need or as much promise for medical breakthroughs as neuroscience.
`Neurological disorders affect approximately one billion people, are the leading cause of disability
`and are the number two cause of death worldwide, second only to cardiovascular disease.
`
`We believe that Biogen is uniquely positioned as a global leader in neuroscience to take on this
`enormous challenge. In 2017 we declared our goal to become the global leader in neuroscience by
`developing transformational therapies to address what we believe are becoming the world’s most
`significant unmet medical needs.
`
`Our strategy is simple: Leverage a strong core business to help drive future growth. Our first three
`strategic priorities focus on fortifying our core business – this is Biogen today:
`
`
`
`
`
`
`
`•
`
`•
`
`•
`
`Maximizing the resilience of our core multiple sclerosis (MS) business to drive
`earnings and cash flow
`Accelerating our progress in spinal muscular atrophy (SMA) as we shift towards
`new growth opportunities
`Creating a leaner and simpler operating model
`
`For the Biogen of tomorrow, we will build upon our core business and a leaner and simpler
`operating model to create new sources of value through:
`
`
`
`
`
`
`•
`
`•
`
`
`Developing and expanding our neuroscience portfolio to create the future growth
`engines of Biogen
`Re-prioritizing our capital allocation efforts to continue to maximize shareholder
`value, with an increased focus on investment for future growth
`
`We are pleased with the work we have done to execute on our strategy, which we believe has led to
`significant progress for Biogen. We know our work is not finished and we remain committed to our
`longer-term goal of becoming the leader in neuroscience and the fastest-growing large cap
`biotech company.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 5
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`

`

`5 | 2017 Biogen Annual Report
`
`EXECUTING ON THE CORE BUSINESS
`
`CREATING NEW SOURCES OF VALUE
`
`Maximizing the resilience of our
`MS core business
`
`Accelerating our progress in
`spinal muscular atrophy
`
`
`
`
`Creating a leaner and simpler
`operating model
`
`Developing and expanding our
`neuroscience portfolio
`
`
`
`Re-prioritizing our capital
`allocation efforts
`
`EXECUTING ON OUR STRATEGY
`We believe we delivered on our strategy in 2017. Our MS business remained core to Biogen’s
`success with global revenues, including royalty revenues on sales of OCREVUS®, increasing 4
`percent over 2016. In addition, the launch of SPINRAZA proved to be one of the most remarkable
`biotech product launches of the year, with approximately 3,200 patients on the therapy3. Our efforts
`combined to deliver strong financial performance, generating an all-time high of $12.3 billion in
`total revenues. Total revenues for 2017 grew by 7 percent over 2016, or a 15 percent increase over
`2016 excluding hemophilia revenues4.
`
`3 As of December 31, 2017, approximately 3,200 patients were receiving SPINRAZA across the post-marketing setting, the expanded access program and
` ongoing clinical trials.
`4 In Q1 2017 Biogen completed the spin-off of its global hemophilia business into a new company, known as Bioverativ Inc. The 15 percent increase in total
` revenues excludes all hemophilia revenues from 2016 through January 2017. Hemophilia revenues include ELOCTATE® and ALPROLIX® product revenues
` as well as royalty and contract manufacturing revenues received from Sobi.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 6
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`2017 Biogen Annual Report | 6
`
`For the Biogen of tomorrow, we plan to build upon our core business to create new sources of value.
`In 2017 we made noteworthy advancements, transitioning five pipeline candidates from research to
`development, nearly doubling our historical productivity. Additionally, we added seven new clinical
`stage programs across our core and emerging growth areas through the advancement of our
`internal candidates and external business development. These programs included:
`
`
`
`
`
`
`
`
`CORE:
`•BIIB098 (monomethyl fumarate prodrug)* in MS
`•BIIB092 (anti-tau mAb) in Alzheimer’s disease
`•BIIB092 (anti-tau mAb) in Progressive Supranuclear Palsy (PSP)
`•BIIB076 (anti-tau mAb)* in Alzheimer’s disease
`•BIIB080 (IONIS-MAPTRx)* in Alzheimer’s disease
`
`
`
`
`
`EMERGING:
`•BIIB093 (glibenclamide IV) in Large Hemispheric Infarction (LHI) Stroke
`•Natalizumab in Epilepsy
`
`*Collaboration programs.
`
`CORE GROWTH AREAS
`
`EMERGING GROWTH AREAS
`
` ~20%
`
`OF ANNUAL
`REVENUES
`INVESTED INTO
`R&D OVER PAST
`DECADE
`
` $12.3b
`
`IN REVENUES
`IN 2017
`
`MS/NEURO-
`IMMUNOLOGY
`
`ALZHEIMER’S
`DISEASE/
`DEMENTIA
`
`MOVEMENT
`DISORDERS
`
`NEURO-
`MUSCULAR
`DISORDERS
`
`PAIN
`
`OPHTHAL-
`MOLOGY
`
`NEURO-
`PSYCHIATRY
`
`ACUTE
`NEUROLOGY
`
`We also re-prioritized our capital allocation with an increased focus on long-term growth while
`continuing to buy back shares opportunistically, repurchasing approximately 4.9 million shares of
`our common stock in 2017 with a total value of $1.4 billion.
`
`In 2017 we further aligned our business to our strategy. We completed the spin-off of our
`hemophilia business as an independent company and we continued construction of our large-scale
`biologics manufacturing facility at Solothurn, Switzerland, which we expect will be operational by the
`end of the decade.
`
`In 2017 we also made several key appointments to our management team, including Jeffery D.
`Capello as Executive Vice President and Chief Financial Officer, Ginger Gregory as Executive Vice
`President and Chief Human Resources Officer and Chirfi Guindo as Executive Vice President and
`Head of Global Marketing, Market Access and Customer Innovation.
`
`Our people and our leaders are at the core of our success. During my time at Biogen, I have been
`inspired by the commitment that all Biogen employees have to patients, to our communities, and to
`our shareholders. I am privileged to work with people who have the talent and skills needed to lead
`Biogen forward.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 7
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`

`7 | 2017 Biogen Annual Report
`
` ~37%
`
`MS PATIENTS
`TREATED WITH
`OUR MEDICINES
`GLOBALLY
`
` 1st
`
`& ONLY APPROVED
`TREATMENT
`FOR SMA
`
` 3
`
`ANTI-TNF
`BIOSIMILARS
`APPROVED
`IN THE EU6
`
`CORE COMMERCIAL PERFORMANCE
`MULTIPLE SCLEROSIS (MS)
`Today, Biogen remains a global leader in all three segments of the MS market: oral, high-efficacy
`and interferons. In 2017, even amid stiff competition, we were resilient with our global MS market
`share of approximately 37 percent, or approximately 340,000 patients.
`
`Our $9 billion MS franchise, including royalty revenues on sales of OCREVUS, has grown revenues
`at a compounded annual growth rate of 14 percent over the last 5 years. TECFIDERA revenues
`rose 6 percent to $4.2 billion in 2017 and TYSABRI remained in a stable market position with
`approximately $2 billion in annual revenues.
`
`We were able to expand U.S. access for our MS portfolio and we are excited to see it implemented
`in 2018. We also executed five value-based contracts in the U.S., which we believe will give us the
`opportunity to learn and develop new contracting models to better serve patients in the future.
`
`SPINAL MUSCULAR ATROPHY (SMA)
`In 2017 the launch of SPINRAZA exceeded expectations. We saw strong SPINRAZA patient growth
`both in the U.S. and outside the U.S. As of December 31, 2017, there were approximately 3,200
`patients on the therapy5.
`
`Worldwide SPINRAZA revenues reached $884 million as we expanded our launch of SPINRAZA
`globally in 2017 and received additional approvals, including in the European Union and Japan.
`SPINRAZA is the first and only approved treatment for SMA, bringing hope for the first time to
`families, infants, teens and young adults.
`
`We were also honored, along with our partner Ionis Pharmaceuticals Inc. (Ionis), when SPINRAZA
`won the prestigious 2017 Prix Galien USA award for the Best New Biotechnology Product.
`
`BIOSIMILARS
`Biogen is a leader in the emerging field of biosimilars through Samsung Bioepis, our joint venture
`with Samsung BioLogics Co. Ltd. Together we are working to expand patient choice and offer
`physicians more options to meet the needs of patients, while delivering savings to healthcare
`systems. Biogen markets two biosimilars in Europe for Samsung Bioepis, BENEPALI (etanercept)
`and FLIXABI (infliximab), serving more than 70,000 patients and generating $380 million in total
`product revenues in 2017, representing a 277 percent increase over 2016. In addition, a third
`biosimilar which we will market, IRMALDI (adalimumab), was approved in the European Union in
`2017 and is expected to launch in Europe in October 2018.
`CREATING NEW SOURCES OF VALUE
`2017 was a transformative year for Biogen Research & Development. We provided clarity on
`Biogen’s strategic priorities and we believe this is where breaking science is opening new avenues
`for drug development. We believe that Biogen has a competitive advantage based on our strong
`track record and intense focus on our core and emerging growth areas within neuroscience. We also
`believe our successful SPINRAZA launch exemplifies our ability to bring new therapies to patients
`in need. Our goal is to leverage our competitive advantage, to target our investments to the areas of
`greatest need and opportunity and to advance a world-class neuroscience R&D engine.
`
`5 As of December 31, 2017, approximately 3,200 patients were receiving SPINRAZA across the post-marketing setting, the expanded access program and
` ongoing clinical trials.
`6 Two currently available for treatment; a third has been granted marketing authorization by the European Commission and is expected to launch in
` Europe in October 2018.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 8
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`2017 Biogen Annual Report | 8
`
`
`ONE OF
`THE LARGEST
`PRODUCERS
`OF BIOLOGICS
`IN BIOTECH
`
` >$2b
`
`SPENT ON R&D
`IN 2017 ALONE
`
` 140
`
`ACTIVE STUDIES7
`
`As we develop and expand our portfolio, we aim to increase overall productivity at every stage,
`balance our portfolio and to continue to implement a robust external portfolio strategy, which may
`include acquisitions, development partnerships for resource flexibility and risk sharing and early
`innovation partnerships.
`
`MULTIPLE SCLEROSIS
`As part of our long-standing commitment to the MS community, we remain dedicated to advancing
`the treatment of MS and building on our leadership in this space. In 2017 we demonstrated this
`commitment by advancing opicinumab (anti-LINGO-1) into a Phase 2b trial for remyelination. We
`also licensed BIIB098, an oral monomethyl fumarate prodrug, from Alkermes Pharma Ireland
`Limited, a subsidiary of Alkermes plc. Furthermore, we strengthened our TECFIDERA intellectual
`property position through a licensing agreement with Forward Pharma A/S (Forward Pharma).
`
`SPINAL MUSCULAR ATROPHY
`As part of our commitment to the SMA community, we remain dedicated to advancing potential
`additional treatment options for SMA. In December 2017 we entered into a new collaboration
`agreement with Ionis to identify additional antisense oligonucleotide (ASO) drug candidates for
`the treatment of SMA. In this collaboration, we are exploring novel chemistries for advancing
`intrathecal ASO-based therapies that have the potential to reduce the dosing burden or increase the
`therapeutic effect of a therapy.
`
`We continue to believe that there is an opportunity in gene therapy and remain committed to
`advancing our gene therapy asset for SMA to clinical trials with the aim of dosing the first patient in
`the middle of 2018.
`
`ALZHEIMER’S DISEASE
`We believe we have the industry’s leading Alzheimer’s disease portfolio and are developing a variety
`of investigational therapies to treat patients with the disease. We have learned from extensive
`research, including from genetics, that Alzheimer’s disease can be driven by amyloid beta and
`that plaque build-up occurs before symptoms of Alzheimer’s disease. Our lead investigational
`compound, aducanumab, is being jointly developed with Eisai Co. LTD (Eisai) as of October 22,
`2017. It is the first to show with clinical data a slowing of the progression of disease as we saw in
`the Phase 1b PRIME trial. The aducanumab investigational compound differs in meaningful ways
`from other investigational compounds because it is highly selective for aggregated forms of amyloid
`beta and substantially removes them from the brain. The results from the Phase 1b PRIME trial
`support the design of our ongoing Phase 3 trials.
`
`In late 2017 the Independent Data Monitoring Committee determined that BAN2401, an anti-
`amyloid beta protofibril antibody that we are jointly developing with Eisai, did not meet the criteria
`for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient
`Phase II trial (Study 201). The results of the final analysis are expected in the second half of 2018.
`
`Beyond aducanumab and BAN2401, we are advancing four other clinical assets in Alzheimer’s
`disease, including E2609, a BACE inhibitor being jointly developed with Eisai, two anti-tau
`antibodies and an anti-tau ASO in collaboration with Ionis.
`
`In 2017 we also renegotiated our agreements with Eisai and Neurimmune AG Subone
`(Neurimmune) with the aim to improve the potential long-term economics of aducanumab.
`
`7 Active study includes all studies between pre-Study Management Team (SMT) formation and Clinical Study Report (CSR) as defined by internal systems as
` of March 9, 2018.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 9
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`

`9 | 2017 Biogen Annual Report
`
`BIOGEN FOR THE FUTURE
`Forty years from now, we may look back at this time as a point of inflection for Biogen as we build
`on our legacy of science and discovery to pursue increasingly complex challenges in neuroscience.
`Leveraging substantial core competencies, including the world’s best neurologists and
`neuroscientists, across a broad set of opportunities, we believe that we are well positioned
`for the future.
`
`We believe we are already executing on our well-defined strategy to deliver near-term results and
`maximize long-term value. We have an energized, world-class executive team – and highly-skilled,
`passionate employees – with clear opportunities in front of us based on the significant unmet
`medical need and breakthroughs we see in neuroscience.
`
`We also recognize that disease knows no borders or financial position. While we remain focused
`on our priority markets, we are selectively expanding Biogen around the world. We also continue to
`look for innovative ways to drive the evolution of the payer market, as evidenced by our value-based
`contracting models. With an evolving payer landscape and possible political and regulatory changes
`likely impacting our industry, we will focus on working to shape the future landscape in an effort to
`place the patient first.
`
`At Biogen, our credo is Caring Deeply. Working Fearlessly. Changing Lives.™ We are committed to
`this philosophy, and we will continually work to improve patient access and health outcomes, build
`supportive communities and inspire future generations of scientists. I am proud of the dedication of
`our employees and the strength of our programs in such areas as diversity and inclusion, safety and
`environmental sustainability. Biogen continues to garner the respect and admiration of its peers
`and the communities in which it operates.
`
`Through all of our work, we maintain the highest levels of ethics and transparency, which are critical
`to building and maintaining trust with patients, providers, our shareholders and other stakeholders.
`
`As we celebrate our 40th anniversary in 2018, I would like to thank our employees around the world
`who are dedicated to making a positive impact on patients’ lives – and all the physicians, caregivers
`and participants in our clinical development programs. Finally, I would like to thank you, my fellow
`shareholders, for your past support and continued confidence in the future of Biogen.
`
`Michel Vounatsos
`Chief Executive Officer
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 10
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`

`
`
`2017 Biogen Annual Report | 102017 Biogen Annual Report | 10
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 11
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`11 | 2017 Biogen Annual Report
`
`Over the past year, I’ve seen a construction site
`turn into a high-tech vision of the future. The
`next-generation biologics manufacturing facility will
`lead the industry in advanced process controls and
`novel techniques. Our motivated and expert staff
`is excited to bring this technological innovation to
`reality and deliver treatments to our patients.
`
`Lilla Csanaky
`Manufacturing Associate,
`Solothurn, Switzerland
`
`We are at a crucial moment in the field of
`neuroscience, and I believe Biogen is positioned
`for the future. Each day, we have an acute sense of
`urgency to develop new medicines that will positively
`impact the lives of millions of patients and caregivers
`around the world.
`
`Teresa G. Cachero, Ph.D., PMP
`Product Development and
`Commercialization Lead BIIB092
`
`2017 was a transformative year for Biogen. We
`delivered one of the most exciting biotech launches
`of the year with SPINRAZA and had a record year for
`MS revenues. I want to thank our employees for their
`continued passion to bring innovative therapies to
`market and dedication to access for
`patients across the U.S.
`
`Dell Faulkingham
`Vice President,
`Head of Neurology
`Marketing and Field Operations
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 12
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`

`2017 Biogen Annual Report | 12
`
`Biogen’s talented engineers and scientists know
`that patients are counting on us. We continuously
`look to improve development, technology transfer
`and product lifecycle management to deliver novel
`therapies to our patients faster and drive Biogen
`forward.
`
`Shishir Ghia
`Associate Director,
`Manufacturing Sciences
`
`I speak with patients, providers and pharmacies
`each day with one key goal in mind: supporting the
`patient. I serve as a connection point to disease
`education, financial assistance, treatment options
`and support services. Having the confidence
`to say to a patient, ‘I can help you with that’
`is empowering.
`
` Tennille Harper
`Universal Patient
`Services Coordinator
`
`Biogen is making an unprecedented investment into
`Alzheimer’s, a devastating neurological disease that
`touches too many. We are at the forefront of research
`and development in this therapeutic area, and we
`believe that our pipeline holds great promise
`for society.
`
`Samantha Budd Haeberlein
`Vice President,
`Clinical Development
`Alzheimer’s Disease
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 13
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`

`

`13 | 2017 Biogen Annual Report
`
`Biogen has invested roughly 20 percent of our
`revenues into research and development over
`the past decade, which is why we’ve managed to
`produce breakthrough treatments in MS and SMA.
`With world-class science, we are changing lives and
`fearlessly taking on some of neuroscience’s
`biggest challenges.
`
`Anirvan Ghosh
`Senior Vice President,
`Research and Early Development
`
`At Biogen, diversity and inclusion live in everything
`we do. It is not just seen as a must-do, it is seen as a
`strength from our leadership to our employees. This
`encourages me to bring my best self to work each
`day, and amplifies our teams’ knowledge, strengths
`and abilities.
`
`Sini Ngobese
`Manager, People Relations
`and Leave Management
`
`The development and approval of SPINRAZA
`exemplifies Biogen’s mission to improve the lives of
`patients. At the end of 2017, approximately 3,200
`patients were receiving the treatment8, and this
`is just the beginning. The pace of discovery and
`innovation in neuroscience is accelerating rapidly.
`
`Wildon Farwell, M.D., MPH
`Senior Medical Director,
`Clinical Development
`
`8 As of December 31, 2017, approximately 3,200 patients were receiving SPINRAZA across the post-marketing setting, the expanded access program and
` ongoing clinical trials.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 14
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`

`2017 Biogen Annual Report | 14
`2017 Biogen Annual Report | 14
`
` 7,000+
`
`EMPLOYEES
`WORLDWIDE
`
` 4
`
`CONSECUTIVE YEARS
`‘BEST PLACE TO WORK’
`FOR LGBT EQUALITY
`IN THE U.S.
`
` 43%
`
`OF DIRECTOR-LEVEL
`EMPLOYEE POSITIONS &
`ABOVE HELD BY WOMEN
`
` 73%
`
`REDUCTION
`IN OPERATIONAL
`CARBON INTENSITY
`SINCE 2006
`
`
`CARBON-NEUTRAL
`COMPANY
`SINCE 2014
`
` 100%
`
`RENEWABLE
`POWER
`COMMITMENT
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 15
`
`

`

`
`
`15 | 2017 Biogen Annual Report15 | 2017 Biogen Annual Report
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 16
`
`

`

`PHASE 1
`
`PHASE 2
`
`PHASE 3
`
`2017 Biogen Annual Report | 16
`
`
`CORE
`GROWTH
`AREA
`
`EMERGING
`GROWTH
`AREA
`
`PRODUCT PIPELINE
`
`MULTIPLE SCLEROSIS AND
`NEUROIMMUNOLOGY
`
`BIIB098 (monomethyl fumarate
`prodrug)* - MS
`
`Opicinumab (anti-LINGO-1) - MS
`
`ALZHEIMER’S DISEASE
`AND DEMENTIA
`
`PARKINSON’S DISEASE
`AND MOVEMENT
`DISORDERS
`
`Aducanumab (Aβ mAb)* - Alzheimer’s
`
`Elenbecestat (E2609)* - Alzheimer’s
`
`BAN2401 (Aβ mAb)* - Alzheimer’s
`
`BIIB092 (anti-tau mAb) - Alzheimer’s
`
`BIIB076 (anti-tau mAb)* - Alzheimer’s
`
`BIIB080 (IONIS-MAPTRx)* - Alzheimer’s
`
`
`BIIB092 (anti-tau mAb) - Progressive
`Supranuclear Palsy (PSP)
`
`BIIB054 (anti-alpha-synuclein mAb) -
`Parkinson’s
`
`NEUROMUSCULAR
`DISEASE INCLUDING
`SMA AND ALS
`
`BIIB067 (IONIS-SOD1Rx)* -
`Amyotrophic Lateral Sclerosis (ALS)
`
`PAIN
`
`BIIB074 (Vixotrigine) - Trigeminal
`Neuralgia
`
`BIIB074 (Nav1.7) - Painful
`Lumbosacral Radiculophath (PLSR)
`
`OPHTHALMOLOGY
`
`BIIB087 (gene therapy)* - X-Linked
`Retinoschisis (XLRS)
`
`ACUTE NEUROLOGY
`
`BIIB093 (glibenclamide IV) - Large
`Hemispheric Infarction (LHI) Stroke
`
`Natalizumab - Epilepsy
`
`OTHER
`
`Dapirolizumab pegol (anti-CD40L)* -
`Systemic Lupus Erythematosus (SLE)
`
`BG00011 (STX-100) -
`Idiopathic Pulmonary Fibrosis (IPF)
`
`BIIB059 (anti-BDCA2) - SLE
`
`
`*Collaboration programs.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 17
`
`

`

`17 | 2017 Biogen Annual Report
`
`EXECUTIVE COMMITTEE
`_______
`(Left to Right Below)
`
`Chirfi Guindo
`Executive Vice President and Head of Global Marketing,
`Market Access and Customer Innovation
`
`Michel Vounatsos
`Chief Executive Officer
`
`Jeffrey D. Capello
`Executive Vice President and
`Chief Financial Officer
`
`Susan H. Alexander
`Executive Vice President,
`Chief Legal Officer and Secretary
`
`Alfred W. Sandrock, Jr., M.D., Ph.D.
`Executive Vice President
`and Chief Medical Officer
`
`Paul F. McKenzie, Ph.D.
`Executive Vice President,
`Pharmaceutical Operations and Technology
`
`Ginger Gregory, Ph.D.
`Executive Vice President and
`Chief Human Resources Officer
`
`Michael D. Ehlers, M.D., Ph.D.
`Executive Vice President,
`Research and Development
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 18
`
`

`

`2017 Biogen Annual Report | 18
`
`FINANCIALS
`_______
`GAAP to Non-GAAP Reconciliation
`
`DILUTED EPS AND NET INCOME ATTRIBUTABLE TO BIOGEN INC.
`(Unaudited, $ in millions, except per share amounts)
`
`FY |
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`GAAP Diluted EPS
`Adjustments to net income attributable to Biogen Inc. (see below)
`
`$7.81
`1.15
`
`$12.37
`1.46
`
`$15.34
`1.67
`
`$16.93
`3.29
`
`$11.92
`9.89
`
`Non-GAAP Diluted EPS
`
`$8.96
`
`$13.83
`
`$17.01
`
`$20.22
`
`$21.81
`
`$2,539
`815
`-
`120
`63
`110
`-
`19
`
`18
`
`1 - - -
`
`
`
`-
`(213)
`1,174
`
`$3,703
`374
`455
`-
`15
`-
`(4)
`18
`
`-
`33
`55
`
`- -
`
`
`-
`(225)
`-
`
`$1,862
`331
`-
`-
`(1)
`
`$2,935
`473
`-
`-
`(39)
`
`$3,547
`365
`-
`-
`31
`
`- -
`
`
`-
`
`-
`93
`
`- - -
`
`
`
`-
`(104)
`-
`
`- -
`
`
`-
`
`- - - -
`
`
`35
`12
`(135)
`-
`
`- -
`
`
`-
`
`- - -
`
`27
`-
`10
`(93)
`-
`
`GAAP Net Income Attributable to Biogen Inc.
`Amortization of acquired intangible assetsA,B
`TECFIDERA litigation settlement chargeA
`Acquired in-process research and development
`Loss (gain) on fair value remeasurement of contingent consideration
`Net distribution to noncontrolling interestsC
`Gain on deconsolidation of variable interest entities
`Hemophilia business separation costs
`Restructuring, business transformation and other cost-saving initiatives:
`
`2017 corporate strategy implementationD
`
`Restructuring chargesD
`
`Cambridge manufacturing facility rationalization costsE
`
`Weston exit costsF
`Donation to Biogen Foundation
`Stock option expense and other
`Income tax effect related to reconciling items
`Tax reformG
`
`Non-GAAP Net Income Attributable to Biogen Inc.
`
`$2,136
`
`$3,281
`
`$3,932
`
`$4,423
`
`$4,645
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 19
`
`

`

`19 | 2017 Biogen Annual Report
`
`FINANCIALS
`_______
`
`(Continued from previous page)
`
`FREE CASH FLOW RECONCILIATION
`(Unaudited, $ in millions)
`
`FY |
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`Net Cash Flows Provided by Operating Activities
`
`$2,345
`
`$2,942
`
`$3,716
`
`$4,522
`
`$4,551
`
`Purchases of property, plant and equipment (Capital Expenditures)
`Contingent consideration related to Fumapharm AG acquisition
`
`(246)
`(15)
`
`(288)
`(375)
`
`(643)
`(850)
`
`(616)
`(1,200)
`
`(867)
`(1,200)
`
`Free Cash Flow
`
`$2,084
`
`$2,279
`
`$2,223
`
`$2,706
`
`$2,484
`
`A Amortization of acquired intangible assets for 2017 includes $444 million of impairment and amortization charges related to the
`intangible assets associated with our U.S. and rest of world licenses to Forward Pharma’s intellectual property, including Forward Pharma’s
`intellectual property related to TECFIDERA. In exchange for these licenses, we paid Forward Pharma $1.25 billion in cash. During the fourth
`quarter of 2016 we recognized a pre-tax charge of $455 million and in the first quarter of 2017 we recognized intangible assets of $795
`million related to this agreement.
`
`We have two intellectual property disputes with Forward Pharma, one in the U.S. and one in the European Union, concerning intellectual
`property related to TECFIDERA. In March 2017 the U.S. intellectual property dispute was decided in our favor. We evaluated the
`recoverability of the U.S. asset acquired from Forward Pharma and recorded an impairment charge in the first quarter of 2017 to adjust
`the carrying value of the acquired U.S. asset to fair value reflecting the impact of the developments in the U.S. legal dispute. In January
`2018 the European Patent Office announced its decision revoking Forward Pharma’s European Patent No. 2 801 355. Based upon our
`assessment of these rulings, we continue to amortize the remaining net book value of the U.S. and rest of world intangible assets in our
`consolidated statements of income utilizing an economic consumption model.
`
`The TECFIDERA litigation settlement charge for 2016 represents the portion of the $1.25 billion cash payment made in the first quarter of
`2017 attributable to our sales of TECFIDERA during the period April 2014 through December 31, 2016.
`
`B Amortization of acquired intangible assets for 2017 includes a $31 million pre-tax impairment charge related to our acquired and in-
`licensed rights and patents intangible asset due to the Article 20 Procedure of ZINBRYTA.
`
`C Net distribution to noncontrolling interests for 2017 reflects the after-tax $150 million upfront payment made to Neurimmune in exchange
`for a 15 percent reduction in royalty rates payable on potential commercial sales of aducanumab. This upfront payment is in relation to the
`amendment of terms of our collaboration agreement with Neurimmune.
`
`D 2017 corporate strategy and restructuring charges for 2017 are related to our efforts to create a leaner and simpler operating model.
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 20
`
`

`

`2017 Biogen Annual Report | 20
`
`FINANCIALS
`_______
`
`(Continued from previous page)
`
`Restructuring charges for 2016 include charges of $18 million incurred in connection with our 2016 restructuring resulting from our
`decision to spin-off our hemophilia business. Restructuring charges for 2016 also include severance charges of $7 million related to
`employee separation costs as a result of our decision to vacate and cease manufacturing in Cambridge, MA and vacate our warehouse
`in Somerville, MA. Restructuring charges for 2016 further include $8 million of costs incurred in connection with our 2015 corporate
`restructuring.
`
`Restructuring charges for 2015 reflect $93 million of charges incurred in connection with our 2015 corporate restructuring.
`
`E Cambridge manufacturing facility rationalization costs for 2016 reflect $46 million of additional depreciation expense included in cost of
`sales, excluding amortization of acquired intangible assets in our condensed consolidated statements of income. Cambridge manufacturing
`facility rationalization costs for 2016 also includes charges of $7 million for the write-down of excess inventory.
`
`F This charge represents the remaining lease obligation for the vacated portion of our Weston, MA facility, net of sublease income upon
`relocation of our headquarters to Cambridge, MA.
`
`G On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the 2017 Tax Act) was signed into law and has resulted in significant changes
`to the U.S. corporate income tax system. The 2017 Tax Act includes a federal statutory rate reduction from 35 percent to 21 percent, the
`elimination or reduction of certain domestic deductions and credits, the transition of U.S. international taxation from a worldwide tax
`system towards a territorial tax system, limitations on the deductibility of interest expense and executive compensation and base-erosion
`prevention measures on future non-U.S. earnings of U.S. entities, which has the effect of subjecting certain of our earnings of foreign
`subsidiaries to U.S. taxation. These changes became effective beginning in 2018.
`
`The 2017 Tax Act also includes a one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries’ previousl