`
`
`2018 2018 2018 2018
`
`
`
`ANNUAL ANNUAL ANNUAL ANNUAL
`
`
`
`REPORTREPORTREPORTREPORT
`
`Biogen 2018 Annual Report
`Biogen 2018 Annual Report
`Biogen 2018 Annual Report
`Biogen 2018 Annual Report
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 1
`
`

`

`
`
`0202
`
`
`
`HIGHLIGHTS & CONTENTSHIGHLIGHTS & CONTENTS
`
`
`
`CEO LETTERCEO LETTER
`
`
`
`STRATEGYSTRATEGY
`
`
`
`CULTURE & ENGAGEMENTCULTURE & ENGAGEMENT
`
`
`
`PRODUCTS & PIPELINEPRODUCTS & PIPELINE
`
`
`
`EXECUTIVE COMMITTEEEXECUTIVE COMMITTEE
`
`
`
`Strong financial performanceStrong financial performanceStrong financial performanceStrong financial performance
`
`
`
`
`
`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
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`
`
`Total Revenues ($ in millions)Total Revenues ($ in millions)
`
`
`
`Strong financial performanceStrong financial performance
`
`
`
`20182018
`
`
`
`$13,453$13,453
`
`
`
`20172017
`
`
`
`20162016
`
`
`
`$12,274$12,274
`
`
`
`$11,449$11,449
`
`
`20152015
`
`$10,764$10,764
`Total Revenues ($ in millions)
`
`20142014
`
`$9,703$9,703
`2018
`
`$13,453
`
`2017
`
`$12,274
`
`
`
`$26.20$26.20
`
`
`Product Revenues Product Revenues
`
`($ in millions and % of total product revenues)($ in millions and % of total product revenues)
`
`
`
`20182018
`
`
`
`20172017
`
`
`Other4Other4
`
`$662 $662
`
`6% 6%
`
`
`$638$638
`
`5%5%
`
`
`TECFIDERATECFIDERA
`
`$4,274 $4,214$4,274 $4,214
`
`
`39% 39%
`41%41%
`
`
`SPINRAZASPINRAZA
`Product Revenues
`
`20172017
`
`$1,724 $884$1,724 $884
`
`
`16% 16%
`9%9%
`($ in millions and % of total product revenues)
`
`
`
`20182018
`
`
`TYSABRITYSABRI
`2018
`2017
`
`$1,864 $1,973$1,864 $1,973
`Other4
`
`
`17% 17%
`19%19%
`$662
`$638
`6%
`5%
`
`+ 5 %+ 5 %
`
`
`Interferon5Interferon5
`
`$2,363 $2,646$2,363 $2,646
`TECFIDERA
`
`
`22% 22%
`26%26%
`$4,274 $4,214
`39%
`41%
`
`2017
`
`2018
`
`HIGHLIGHTS
`HIGHLIGHTS
`
`HIGHLIGHTS
`
`02
`
`2016
`$11,449
`
`GAAP Diluted EPS/Non-GAAP Diluted EPS 1GAAP Diluted EPS/Non-GAAP Diluted EPS 1
`2015
`$10,764
`
`20182018
`
`$21.58(cid:31)$21.58(cid:31)
`2014
`$9,703
`
`20172017
`
`
`
`$21.81$21.81
`
`
`
`$11.92(cid:31)$11.92(cid:31)
`
`
`
`20162016
`
`
`
`$16.93$16.93
`
`
`
`$20.22$20.22
`
`
`20152015
`
`
`$15.34$15.34
`$17.01$17.01
`GAAP Diluted EPS/Non-GAAP Diluted EPS 1
`
`20142014
`
`
`$12.37$12.37
`$13.83$13.83
`2018
`$21.58(cid:31)
`
`$26.20
`
`2017
`
`$11.92(cid:31)
`
`Free Cash Flow 1,3 ($ in millions) Free Cash Flow 1,3 ($ in millions)
`2016
`$16.93
`$20.22
`
`$21.81
`
`
`20182018
`2015
`
`
`20172017
`2014
`
`
`
`20162016
`
`$15.34
`
`$17.01
`
`
`
`$3,917$3,917
`
`$12.37
`
`
`$2,484$2,484
`$13.83
`
`
`
`$2,706$2,706
`
`
`20152015
`
`$2,223$2,223
`Free Cash Flow 1,3 ($ in millions)
`
`20142014
`
`$2,279$2,279
`2018
`
`$3,917
`
`2017
`
`2016
`
`2015
`
`$2,484
`
`$2,706
`
`$2,223
`
`
`
`SPINRAZA
`$1,724 $884
`16%
`9%
`
`Increase in total product revenues year over yearIncrease in total product revenues year over year
`TYSABRI
`Interferon5
`$1,864 $1,973
`$2,363 $2,646
`17%
`19%
`22%
`26%
`
`+ 5 %
`
`Increase in total product revenues year over year
`
`
`Product Revenues by Region Product Revenues by Region
`
`(% of total product revenues)(% of total product revenues)
`
`
`
` U.S. U.S.
`
` Rest of the world Rest of the world
`
`
`
`62.5%62.5%
`
`
`
`
`20182018
`37.5%37.5%
`67.8%67.8%
`Product Revenues by Region
`(% of total product revenues)
` U.S.
`
` Rest of the world
`
`
`
`20172017
`
`
`
`32.2%32.2%
`
`
`
`71.8%71.8%
`
`
`
`20162016
`
`
`
`28.2%28.2%
`
`62.5%
`
`2018
`
`37.5%
`
`67.8%
`
`2017
`
`32.2%
`
`
`4 For 2018 and 2017 Other includes product revenues from FAMPYRA, 4 For 2018 and 2017 Other includes product revenues from FAMPYRA,
`
`FUMADERM, BENEPALI, FLIXABI and ZINBRYTA. For 2018 Other also FUMADERM, BENEPALI, FLIXABI and ZINBRYTA. For 2018 Other also
`
`includes product revenues from IMRALDI, which was launched in Europe includes product revenues from IMRALDI, which was launched in Europe
`
`in October 2018. For 2017 Other also includes product revenues from in October 2018. For 2017 Other also includes product revenues from
`2016
`71.8%
`28.2%
`
`ALPROLIX and ELOCTATE through January 31, 2017. No product revenues for ALPROLIX and ELOCTATE through January 31, 2017. No product revenues for
`
`ALPROLIX and ELOCTATE were recognized subsequent to February 1, 2017, ALPROLIX and ELOCTATE were recognized subsequent to February 1, 2017,
`
`the effective date of the spin-off of our hemophilia business.the effective date of the spin-off of our hemophilia business.
`
`5 Interferon includes AVONEX and PLEGRIDY. 5 Interferon includes AVONEX and PLEGRIDY.
`
`4 For 2018 and 2017 Other includes product revenues from FAMPYRA,
`FUMADERM, BENEPALI, FLIXABI and ZINBRYTA. For 2018 Other also
`includes product revenues from IMRALDI, which was launched in Europe
`in October 2018. For 2017 Other also includes product revenues from
`ALPROLIX and ELOCTATE through January 31, 2017. No product revenues for
`ALPROLIX and ELOCTATE were recognized subsequent to February 1, 2017,
`the effective date of the spin-off of our hemophilia business.
`5 Interferon includes AVONEX and PLEGRIDY.
`
`2014
`$2,279
`
`1 Non-GAAP diluted earnings per share (EPS) and Free Cash Flow are 1 Non-GAAP diluted earnings per share (EPS) and Free Cash Flow are
`
`Non-GAAP financial measures. A reconciliation of GAAP to Non-GAAP Non-GAAP financial measures. A reconciliation of GAAP to Non-GAAP
`
`diluted EPS and Free Cash Flow amounts is set forth on pages 19–21 diluted EPS and Free Cash Flow amounts is set forth on pages 19–21
`
`of this Annual Report.of this Annual Report.
`
`2 GAAP diluted EPS for 2018 and 2017 includes charges of $125 million and 2 GAAP diluted EPS for 2018 and 2017 includes charges of $125 million and
`
`$1,176 million, respectively, related to the impact of the Tax Cuts and Jobs $1,176 million, respectively, related to the impact of the Tax Cuts and Jobs
`
`Act of 2017.Act of 2017.
`
`3 Free Cash Flow for 2018 and 2017 reflects an increase in capital 3 Free Cash Flow for 2018 and 2017 reflects an increase in capital
`
`expenditures related to the construction of our large-scale biologics expenditures related to the construction of our large-scale biologics
`
`manufacturing facility in Solothurn, Switzerland.manufacturing facility in Solothurn, Switzerland.
`1 Non-GAAP diluted earnings per share (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 19–21
`of this Annual Report.
`2 GAAP diluted EPS for 2018 and 2017 includes charges of $125 million and
`$1,176 million, respectively, related to the impact of the Tax Cuts and Jobs
`Act of 2017.
`3 Free Cash Flow for 2018 and 2017 reflects an increase in capital
`expenditures related to the construction of our large-scale biologics
`manufacturing facility in Solothurn, Switzerland.
`
`2018 Annual Report
`2018 Annual Report
`Biogen
`Biogen
`
`2018 Annual Report
`Biogen
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 2
`
`

`

`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`03
`
`CONTENTS
`
`2018 Annual Report
`Biogen
`
`002 Highlights
`004 CEO Letter
`008 Strategy
`010 Culture & Engagement
`014 Products & Pipeline
`018 Executive Committee
`
`019 GAAP to Non-GAAP Reconciliation
`022 Safe Harbor
`023
`2018 Annual Report on Form 10-K
`215 Corporate Information
`
`COVER: Natalia Wylie and daughter Sofia, who has
`infantile onset (Type 1) SMA treated with SPINRAZA.
`
`THIS PAGE: Nuclear Magnetic Resonance (NMR)
`is used to characterize small molecules and ASOs.
`Using NMR instruments, we can identify impurities
`that may occur during synthesis.
`
`Biogen is focused on
`discovering, developing
`and delivering innovative
`therapies for people living
`with serious neurological and
`neurodegenerative diseases.
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 3
`
`

`

`04
`
`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`Building for sustainable leadership
`
`My fellow stockholders,
`
`2018 was an important year as we took significant steps
`in strengthening our leadership in our core business and
`advancing our pipeline.
`
`However, before I comment on our 2018
`performance, I would like to acknowledge
`the discontinuation of the Phase 3
`ENGAGE and EMERGE stud-
`ies of aducanumab in
`Alzheimer's disease (AD)
`that we announced in
`March 2019.
`
`This disappointing news
`reaffirmed the complexity
`of treating AD. We are
`grateful to the patients,
`their families and inves-
`tigators who participated
`in the studies. We know
`that the sobering reality
`of drug discovery is that
`many studies will fail before
`one succeeds. We are committed to
`learning from these clinical studies and
`furthering the scientific understanding of this
`terrible disease.
`
`We believe our foundation and future remain strong.
`Neurological diseases are the #1 cause of disability and
`the #2 cause of death worldwide1. The prevalence and
`societal burden of these diseases are massive and are
`
`increasing as the aging population continues to grow.
`Few other areas of medicine hold as much promise for
`scientific breakthroughs.
`
`In 2018 we maintained our market leadership in our core
`franchise of multiple sclerosis (MS) and made prog-
`ress toward building a neuromuscular disease
`franchise with the expansion of SPINRAZA,
`the first approved treatment for
`spinal muscular atrophy (SMA),
`a rare neurological disease.
`
`Our view is that neurolog-
`ical diseases are deeply
`connected. Because the
`pathways of these diseas-
`es are interrelated, we
`believe the potential ap-
`proaches for treating them
`are as well. Our success
`in MS gives us insight into
`many other disease areas.
`For example, research in
`remyelination and repair,
`neuroprotection and axonal
`health could have applications in
`AD, amyotrophic lateral sclerosis (ALS),
`Parkinson’s disease, stroke and pain.
`
`We are working to build a multi-franchise therapeutic
`portfolio and to create new sources of value by
`diversifying our pipeline. In 2018 we made progress in
`movement disorders such as Parkinson’s disease and in
`neuromuscular disorders such as ALS.
`
`1 Source: Lancet Neurology, 2017; DRG 2017, American Heart Association, American Parkinson’s Disease Association, The ALS Association.
`
`CEO LETTER
`
`MAY
` – Initiated Phase 2
`TANGO study of BIIB092
`(gosuranemab) for AD
`
`Achievements in 2018
`
`JANUARY
` – Acquired BIIB100 (XPO1
`inhibitor), a Phase 1 ready
`asset primarily for ALS
`
`APRIL
` – Acquired BIIB104 (AMPA),
`a first-in-class Phase 2b
`asset for CIAS
`
`2018 Annual Report
`Biogen
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 4
`
`

`

`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`05
`
`2018 core business performance
`In 2018 we generated an all-time
`high of $13.5 billion in total revenues
`for the year, a 10% increase over
`the prior year, and we generated net
`cash flows from operations of $6.2 bil-
`lion. GAAP diluted earnings per share for 2018
`were $21.58, an increase of 81% over 2017, and
`Non-GAAP diluted earnings per share increased 20%
`over the prior year to $26.20.
`
`These results reflect the resilience of our core MS busi-
`ness, the continued strong global launch of SPINRAZA
`and the ongoing growth of our biosimilar business.
`
`With approximately 35% of MS patients treated with
`our medicines globally, in 2018 we continued to be
`the leader in MS, and we remain firmly committed
`to the MS community. Our MS portfolio ranges from
`symptomatic treatments to disease modifying therapies,
`which enables us to address diverse patient needs
`across disease stages, and we have continued to push
`forward. In December Alkermes, with whom we have
`a license and collaboration agreement, submitted a
`New Drug Application (NDA) to the U.S. Food and Drug
`Administration (FDA) for diroximel fumarate (BIIB098), a
`potential treatment for relapsing forms of MS (RMS). If
`approved, we will be responsible for marketing diroximel
`fumarate, which we plan to do under the brand name
`VUMERITY, a name conditionally accepted by the FDA.
`
`In SMA, SPINRAZA revenues for 2018 nearly doubled
`year over year with total global revenues of $1.7 billion,
`which was driven by strong revenue growth in both the
`
`
`We are working to
`build a multi-franchise
`therapeutic portfolio and
`to create new sources
`of value by diversifying
`our pipeline.
`
`
`U.S. and international markets. Since
`its launch two years ago, SPINRAZA,
`our first product based on the anti-
`sense oligonucleotide (ASO) platform,
`has become the standard of care in
`SMA. By the end of 2018 SPINRAZA had
`been approved in over 40 countries and had
`received formal reimbursement in 30 countries.
`Including clinical trials and our Expanded Access
`Program, as of year-end, more than 6,600 patients
`have benefited from this remarkable therapy.
`
`Additionally, in November, SPINRAZA won the prestigious
`International Prix Galien for Best Biotechnology
`Product – its seventh Prix Galien, following six individual
`country awards.
`
`The efficacy and safety profile of SPINRAZA are evi-
`denced by our long-term data and mounting real-world
`evidence. This includes the unprecedented efficacy data
`in pre-symptomatic infants as demonstrated by the new
`interim results from the NURTURE clinical study evaluat-
`ing efficacy and safety that we announced in October.
`
`Our 2018 revenues also grew as a result of the
`continued expansion of our biosimilar business. Our
`biosimilars revenues increased 44% over the prior
`year. This growth was primarily driven by the success
`of BENEPALI (an etanercept biosimilar referencing
`ENBREL), as well as the continued growth of FLIXABI
`(an infliximab biosimilar referencing REMICADE) and the
`October launch of IMRALDI (an adalimumab biosimilar
`referencing HUMIRA) in several European markets.
`We believe biosimilar products benefit patients and
`
`2018 Annual Report
`Biogen
`
`JUNE
` – Acquired exclusive option for TMS-
`007 for acute ischemic stroke
`
`JULY
` – Acquired Phase 1a BIIB110 (ActRIIA/B
`ligand trap) and pre-clinical ALG-802 for
`neuromuscular indications
`
` – Expanded strategic collaboration with Ionis
`to develop novel ASO drug candidates
` – Launched Aby/Cleo app to support
`individuals with MS
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 5
`
`

`

`06
`
`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`are strategically important as we work with payers and
`health systems globally with the goal of creating room in
`healthcare budgets for innovative therapies. Based on
`our internal estimates, BENEPALI has created savings of
`up to €800 million annually across Europe.
`
`The launch of SPINRAZA and the growth of our biosimilar
`business have led to meaningful revenue growth outside
`of the U.S. and the expansion of our global footprint.
`At the end of 2018 ex-U.S. product revenues were 37%
`of our product revenues, up from 32% of our product
`revenues in 2017.
`
`Overall, our business and cash generation remained
`strong and continued to provide us with flexibility to allo-
`cate capital. In 2018 we spent a total of approximately
`$1.8 billion to develop and expand our pipeline as we
`signed six business development deals and increased
`our ownership in Samsung Bioepis Co., Ltd.
`(Samsung Bioepis), our joint venture with
`Samsung BioLogics Co. Ltd. (Samsung
`BioLogics). We also made share
`repurchases totaling approximately
`$4.4 billion. We plan to continue
`evaluating new opportunities for
`business development as we aim to
`create long-term stockholder value
`and in March 2019 we announced a
`new program for the repurchase of up
`to $5 billion of our common stock.
`
`2018 pipeline progress
`2018 was also a productive year with great strides
`in innovation and achievements of clinical milestones.
`We continued to build momentum by adding depth in
`our core growth areas (MS and neuroimmunology, AD
`and dementia, movement disorders and neuromuscular
`disorders) and by advancing our emerging growth areas
`(acute neurology, neurocognitive disorders and pain).
`We expanded and advanced our pipeline by adding six
`new clinical programs and completed enrollment of
`
`CEO LETTER
`
`late-stage studies, including the PASSPORT study for
`progressive supranuclear palsy (PSP) and the AFFINITY
`study for MS.
`
`We believe our expansion into movement disorders
`holds great promise. We initiated the Phase 2 SPARK
`study of BIIB054 (anti-α-synuclein) in Parkinson’s
`disease and completed enrollment of our Phase 2
`PASSPORT study of BIIB092 (gosuranemab) in PSP, a
`disease leading to loss of balance, slowing of movement,
`difficulty moving the eyes and dementia.
`
`We also made progress in neuromuscular disorders by
`acquiring BIIB110 (ActRIIA/B), a muscle enhancement
`program for investigation in ALS and SMA, and advanc-
`ing programs based on the ASO platform. We believe
`ASOs hold great promise to directly target the genetic
`and pathological origin of disease. We initiated a
`Phase 1 study of BIIB078 (IONIS-C9Rx), an
`ASO drug candidate, for ALS targeting
`C9ORF72, which is the most common-
`ly inherited cause of ALS.
`
`In the fourth quarter of 2018 we
`and our collaboration partner
`Ionis Pharmaceuticals, Inc. (Ionis)
`announced results from a positive in-
`terim analysis of the ongoing Phase 1
`study of BIIB067 (tofersen)
`in ALS with superoxide dismutase
`1 (SOD1) mutations, a genetic form of
`ALS representing approximately 2% of all ALS
`patients. This interim analysis demonstrated both
`proof-of-biology and proof-of-concept with a concordance
`across multiple clinical and biomarker endpoints. Based
`on these results, we initiated and dosed the first patient in
`the anticipated Phase 3 VALOR study, a continuation of
`the Phase 1/2 single- and multiple- ascending dose study.
`
`We remain committed to research in AD and to support-
`ing the millions of patients affected by this devastating
`
`Our goal is to deliver
`innovative therapies for
`patients and invest in
`the areas of highest return
`to deliver long-term value
`to our stockholders.
`
`SEPTEMBER
` – Enrolled first patient in Phase 3 CHARM
`study of BIIB093 (glibenclamide IV) for LHI
`
`OCTOBER
`– FDA granted BIIB092 (cid:9)(cid:72)(cid:80)(cid:84)(cid:86)(cid:83)(cid:66)(cid:79)(cid:70)(cid:78)(cid:66)(cid:67)(cid:10) fast
`track designation for PSP
`
`– Completed enrollment of Phase 2 PASSPORT
`study of BIIB092 (cid:9)(cid:72)(cid:80)(cid:84)(cid:86)(cid:83)(cid:66)(cid:79)(cid:70)(cid:78)(cid:66)(cid:67)(cid:10) for PSP
`– Completed enrollment of Phase 2b AFFINITY
`study of opicinumab (anti-LINGO) for MS
`
` – Launched IMRALDI, an adalimumab biosimilar
`referencing HUMIRA, in Europe
` – Presented new interim results from the ongoing
`NURTURE study for SPINRAZA
`
`2018 Annual Report
`Biogen
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 6
`
`

`

`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`07
`
`I would like to thank all of our employees for their con-
`tinuing dedication to the business and their unwavering
`commitment to the patients we serve. Pioneering
`means learning along the way and altering the course
`when it becomes evident that there is a better path.
`We are on an exciting journey, fueled by our passion
`for innovation and groundbreaking science. We care
`deeply about making a difference. We work fearlessly.
`We do not give up even when challenged, pursuing
`innovation in all that we do. We are humbled by the
`opportunity to change lives.
`
`Michel Vounatsos
`Chief Executive Officer
`
`disease. We will continue to advance our tau-related
`programs, including BIIB092 (gosuranemab) and
`BIIB080 (IONIS-MAPTRx), and plan to refocus on early
`research to understand the biology and genetic origins of
`disease for our remaining AD portfolio.
`
`In our emerging growth areas, we initiated four new
`studies, including the Phase 3 CHARM study for BIIB093
`(glibenclamide IV) in large hemispheric infarction (LHI),
`a severe form of ischemic stroke. We also expanded our
`pipeline with the addition of BIIB104 (AMPA) for cognitive
`impairment associated with schizophrenia (CIAS) and our
`option for TMS-007 for acute ischemic stroke.
`
`Looking ahead
`Our solid financial performance in 2018 underpinned
`our continued investment in research and development
`and global business expansion. We will continue to be
`financially disciplined and focused on implementing a
`lean and simple operating model. We are committed to
`continuous improvement across all of our operations,
`something that demands a thoughtful approach toward
`all our investments over both the short and long term.
`
`We aim to continue our momentum in 2019. To deliver
`on our aspirations, we will remain focused on executing
`on our strategic priorities in our core business of MS and
`SMA and developing and expanding our portfolio. Across
`the portfolio, we are prioritizing resources based on
`what we believe are the most promising programs, and
`we plan to continue to significantly invest in research
`and development.
`
`This is a remarkable time for Biogen and all our stake-
`holders. We believe we are well-positioned to address
`the significant unmet medical need in neuroscience, as
`well as in adjacent therapeutic areas where we currently
`have assets or expertise. Our goal is to deliver innovative
`therapies for patients and invest in the areas of highest
`return to deliver long-term value to our stockholders.
`
`NOVEMBER
` – Increased ownership in Samsung Bioepis
`joint venture to approximately 49.9%
`
`DECEMBER
` – Alkermes submitted a NDA to the FDA for review
`of BIIB098 (diroximel fumarate) for RMS
`
`2018 Annual Report
`Biogen
`
` – SPINRAZA awarded as Best Biotechnology
`Product by International Prix Galien
` – Initiated Phase 3b NOVA study evaluating
`the efficacy of extended interval dosing for
`(cid:53)(cid:58)(cid:52)(cid:34)(cid:35)(cid:51)(cid:42) (cid:9)natalizumab(cid:10)
`
`– Dosed first patient in Phase 2b TALLY study of BIIB104 (AMPA) in CIAS
`– Announced positive results from Phase 1 study of BIIB067 ((cid:85)(cid:80)(cid:71)(cid:70)(cid:83)(cid:84)(cid:70)(cid:79))
` in ALS with SOD1 mutations
`– Entered into agreement to investigate the use of C4 Therapeutics'
`novel protein degradation platform
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 7
`
`

`

`08
`
`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`Delivering today and
`investing for future growth
`
`We are focused on neuroscience,
`and our goal is to further expand
`our multi-franchise portfolio.
`
`Our strategy is rooted in the
`fact that the unmet
`need in neurosci-
`ence is vast, and
`we believe that
`no other area of
`medicine holds
`as much promise
`for scientific
`breakthroughs.
`Despite medical
`advances, many
`neurological diseases
`remain largely untreated,
`and there is a significant and
`growing opportunity to make a differ-
`ence in the lives of many patients.
`
`We believe that neurological diseas-
`es and the therapeutic strategies
`to treat them are interconnected.
`We have identified a set of scientific
`hypotheses with the potential to
`unlock breakthroughs across our
`disease areas. Knowledge gained from one
`area may resonate across our pipeline.
`
`Continuing to build a
`multi-franchise portfolio
`
`MS FRANCHISE
`
`YESTERDAY
`
`CLOCKWISE FROM TOP: Our employees
`are preparing the Astrios EQ cell sorter
`for a single cell sort of neurons to further
`understand the biology of Biogen’s anti-tau
`antibody supporting AD research; post-
`doctoral scientist prepares crystals of
`IRAK4, a CNS target involved in stroke for
`x-ray diffraction analysis; gel electrophoretic
`analysis of recombinant GSK3α constructs.
`
`SMA
`
`MS FRANCHISE
`
`TODAY
`
`BIOSIMILARS
`
`STRATEGY
`
`2018 Annual Report
`Biogen
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 8
`
`

`

`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`09
`
`Our strategy is to execute on our core business by max-
`imizing our resilience in MS, accelerating our progress
`in SMA and creating new sources of value by developing
`and expanding our pipeline. We are focused on our
`core growth areas of MS and neuroimmunology, AD and
`dementia, movement disorders and neuromuscular
`disorders, and our emerging growth areas of acute neu-
`rology, neurocognitive disorder, pain and ophthalmology.
`
`We are focused on delivering on our strategy today and
`investing in future growth. We must remain financially
`disciplined with the aim of continuous improvement. We
`have reprioritized our capital allocation to support our
`strategy; namely, investing in research and development
`and business development. With our deep and diversi-
`fied pipeline, strong execution capabilities and financial
`strength, we believe we can deliver on our strategy.
`
`Our biosimilar business is complementary to our strat-
`egy. We believe savings enabled by biosimilars provide
`payers and health systems globally the budgetary
`headroom to fund innovation.
`
`NEUROCOGNITIVE DISORDERS
`
`PAIN
`
`ALZHEIMER'S DISEASE FRANCHISE
`
`THERAPEUTIC ADJACENCIES
`
`THERAPEUTIC ADJACENCIES
`
`OPHTHALMOLOGY FRANCHISE ¹
`
`OPHTHALMOLOGY FRANCHISE 1
`
`STROKE
`
`ACUTE NEUROLOGY FRANCHISE
`
`MOVEMENT DISORDER FRANCHISE
`
`MOVEMENT DISORDER FRANCHISE
`
`NEUROMUSCULAR FRANCHISE
`
`NEUROMUSCULAR FRANCHISE
`
`2018 Annual Report
`Biogen
`
`MS FRANCHISE
`
`EARLY 2020s
`
`BIOSIMILARS
`
`MS FRANCHISE
`
`OUR VISION
`
`BIOSIMILARS
`
`1 In March 2019 we entered into an agreement to acquire Nightstar Therapeutics plc, a clinical-stage gene therapy company focused on AAV treatments for
`inherited retinal disorders. The closing of the proposed acquisition of Nightstar Therapeutics plc remains subject to customary closing conditions, including
`the approval by Nightstar Therapeutics stockholders and the issuance of an order by the U.K. Court.
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 9
`
`

`

`10
`
`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`Living our elements
`
`Much like the periodic table of elements
`documents the building blocks of the
`universe around us, the Biogen Elements
`give shape to our company’s culture.
`
`How we work
`The Biogen Elements promote a unified approach to our
`individual jobs – strengthening our mission, informing our
`leadership, expanding our impact and fueling our growth.
`
`As we remain focused on discovering, developing
`and delivering innovative therapies, we remain
`customer focused. We keep patients,
`payers and physicians front and
`center in our daily work and collab-
`orate to solve critical scientific and
`business challenges. In doing so, we
`foster an inclusive community, both
`internally and externally. We work in
`partnership to break down siloes and
`encourage diverse perspectives and
`backgrounds at all levels.
`
`A pioneering spirit permeates our work.
`We challenge the status quo and experiment
`to create new possibilities. We are not afraid to take
`calculated risks and learn from failure. We are resilient
`and agile, adapting in response to internal changes and
`external disruptors and developing solutions quickly to
`take advantage of emerging opportunities.
`
`We hold ourselves accountable for our work and results.
`We honor our commitments, and we never compromise
`our integrity. We sustain an ethical environment of
`trust, honesty and transparency while ensuring appropri-
`ate confidentiality. We take responsibility for upholding
`our reputation.
`
`CARE DEEPLY DAY 2018:
`On September 21, employees volunteered
`at the Museum of Life and Science in
`Durham, N.C. (top), and on September 14,
`employees volunteered at West Somerville
`Neighborhood School in Somerville, Mass.
`
`Diversity and inclusion
`At Biogen, we believe that a diverse and inclusive work-
`place allows us to empower our global workforce, foster
`innovation and achieve better business results. Diversity
`and inclusion lead to better teamwork and collaboration,
`create a climate of respect and trust, and cultivate an
`environment where employees feel empowered to work
`fearlessly. In 2018 we launched our company-wide
`Diversity and Inclusion Strategy, which aims to build
`inclusive talent systems, drive health equity in the disease
`areas we treat and ensure diversity and inclusion are
`owned by everyone within Biogen.
`
`CULTURE
`
`2018 Annual Report
`Biogen
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 10
`
`

`

`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`11
`
`
`
`Aby/Cleo
`Our app for MS patients
`
`We believe that regardless of their treatment
`choices, MS patients should always be informed,
`supported and inspired to aim for better tomorrows.
`We created innovative solutions and services to
`further support patients “beyond the pill” – offering
`products specifically designed for people who live
`with neurological conditions. In 2018 we launched a
`mobile app, called Aby in the U.S. and Cleo outside
`the U.S., created to serve as a digital companion for
`people living with MS and those who support them.
`Individuals are able to access personalized content
`and track their health in a way that can easily be
`shared with their healthcare professionals.
`
`Engagement with the app was achieved through
`a customer-centric approach, involving more than
`150 patients, 60 healthcare professionals and
`6 Patient Advocacy Groups assisting in the app
`design process.
`
`Caroline Craven (pictured below), an MS patient
`and Aby user, explains that understanding MS goes
`beyond the disease and therapies: “It's about some-
`body learning to live better, learning new life skills,
`learning to manage their life with their medicine and
`their healthcare professionals as one big picture.”
`
`2018 Annual Report
`2018 Annual Report
`Biogen
`Biogen
`
`120,000 +
`
`downloads as of
`December 31, 2018
`
`44 %
`
` of director-level and above
`
`positions held by women
`
`48 %
`
`of manager-level and above
`positions held by women
`
`We are honored to be recognized as a company of
`choice for employees. In 2018 Biogen was ranked
`#51 on the Forbes list of World’s Best Employers, as
`well as one of the Best Employers for Women (at #38).
`We scored 100% on the 2018 Disability Equality
`Index, which measures our policies and practices
`related to disability inclusion. Additionally, for the
`fifth consecutive year, we were recognized as a
`Best Place to Work for LGBTQ Equality by the Human
`Rights Campaign, scoring 100% on their
`Corporate Equality Index.
`
`Caring deeply
`Caring about our
`communities is enshrined in
`our Care Deeply Day. Since
`2011 we have set aside
`this annual global day of
`volunteer service to enable
`all employees to reach out
`and have an impact in their
`local communities. In 2018
`over 3,200 employees
`volunteered for 60 projects
`in 30 locations in
`28 countries.
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 11
`
`

`

`12
`
`HIGHLIGHTS & CONTENTS
`
`CEO LETTER
`
`STRATEGY
`
`CULTURE & ENGAGEMENT
`
`PRODUCTS & PIPELINE
`
`EXECUTIVE COMMITTEE
`
`ABOVE:
`Cambridge
`Community Lab
`student conducts an
`experiment.
`
`Our commitment to environmental sustainability
`We’ve remained carbon neutral since 2014 by driving
`sustainability internally, working with our suppliers and
`investing in renewable resources. We are committed
`to utilizing a science-based approach to reduce our
`environmental footprint, demonstrated by our Science
`Based Targets Initiative-approved 2030 absolute
`greenhouse gas reduction target of 35%. Our practice
`of using science to inform our targets when possible
`is part of our broader commitment to context-based
`sustainability. We also embrace green chemistry and
`continue to explore ways to make our drug discovery and
`development processes safer, more efficient and more
`sustainable while also saving costs.
`
`100%
`
`total renewal electricity
`purchased by Biogen
`
`$ 10 million
`
`committed to STEM education by the Biogen
`Foundation through the STAR program
`
`Engaging in our
`communities
`
`We work to have an impact beyond
`our medicines as we strive to improve
`patient health outcomes, solve social
`and environmental challenges, support
`local communities and inspire future
`generations of scientists.
`
`Our support for youth and education
`The Biogen Foundation supports access to science
`education for diverse populations and to essential human
`services for children and their families. Since 2002 we’ve
`served more than 50,000 middle and high school stu-
`dents in our two Community Labs, giving them a hands-on
`introduction to science. In January the Biogen Foundation
`launched STAR, a $10 million initiative over four years
`to drive the development of local STEM (science, tech-
`nology, engineering and math) education ecosystems in
`Cambridge and Somerville, Mass.
`
`Our contribution to workplace health and safety
`We made significant progress in 2018 integrating
`Human Performance into our Environmental, Health and
`Safety strategy and programs