throbber
2012 ANNUAL REPORT BIOGENIDEC.COM/AR2012
`
`LISA SINDONI
`Mother, Dog Lover, Inspiration
`
`A Company Aligned.
`A Mission Defined.
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`

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`Revenues
`$ in millions
`
`$4,089
`
`$4,377
`
`$4,716
`
`$5,049
`
`$5,516
`
`08 09 10 11 12
`
`Non-GAAP Diluted EPS*
`$
`
`$3.66
`
`$4.12
`
`$5.15
`
`$5.90
`
`$6.53**
`
`08 09 10 11 12
`
`Free Cash Flow*
`$ in millions
`
`$1,286
`
`$909
`
`$1,452
`
`$1,520
`
`$1,625
`
`08 09 10 11 12
`
`*Non-GAAP diluted EPS and free cash fl ow are non-GAAP fi nancial measures. A reconciliation
`of GAAP to non-GAAP diluted EPS and free cash fl ow amounts are set forth on pages 14 and 15
`of this annual report.
`
`**2012 Non-GAAP diluted EPS was impacted by a tax correction which increased tax expense
`by $29 million and reduced EPS by approximately 12 cents
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`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 2
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`

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`GEORGE A. SCANGOS, PH.D.
`
`Chief Executive Offi cer
`
`Dear Fellow Shareholders:
`
`For everyone who counts
`on Biogen Idec, 2012 was an
`extraordinary year – a period
`of significant transformation and
`remarkable accomplishments
`across the organization.
`
`Since our last annual report,
`Biogen Idec has matured as a
`vibrant organization.
`
`Our core business has grown,
`we are preparing for several
`potential product launches in
`the near future, and we have
`made real progress in enhancing
`our early stage research and
`development (R&D) pipeline.
`
`
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`

`

`Since the beginning of 2012, we reported
`results from fi ve pivotal clinical trials – four of
`which met their endpoints, and all of which were
`scientifi cally valuable.
`
`We substantially improved our R&D platform
`while developing a new approach to the way in
`which innovation is generated and nurtured in the
`biopharmaceutical sector. We have strengthened
`our production capabilities and continued our
`internal cultural transformation.
`
`Today we are fully aligned behind a crisply
`defi ned mission and business strategy.
`
`As we enter Biogen Idec’s 35th year, we
`have positioned our company squarely at the
`intersection of science, medicine and economics.
`
`Our goal is to discover, develop and deliver
`new therapeutics that lead to a meaningful
`improvement in the lives of patients, and to
`demonstrate the real-world economic impact
`of those therapies in order to gain appropriate
`reimbursement from payors around the world.
`In so doing, we will defi ne our future.
`
`Our efforts in 2012 generated
`strong fi nancial results. Revenue
`for the year was $5.5 billion, a 9
`percent increase over 2011, and we
`enjoyed growth in both EPS and
`free cash fl ow.
`
`Biogen Idec delivered real rewards to you,
`our shareholders, and entered 2013 on solid
`fi nancial footing with signifi cant momentum.
`
`Advancing
`Commercial Success
`Biogen Idec’s leadership in multiple sclerosis
`(MS) treatment continues to be the foundation
`of our commercial strength; in 2012 this core
`franchise performed exceptionally well, delivering
`full-year revenue growth of 9 percent over 2011.
`
`AVONEX®, one of the most prescribed
`treatments for relapsing forms of multiple
`sclerosis worldwide, gained global market share
`within the class of injectable front-line therapies,
`thanks to strong commercial execution and the
`introduction of two improvements: the AVONEX
`PEN® auto-injector, and the AVOSTARTGRIP®
`titration kit, which helps reduce the frequency
`and severity of fl u-like symptoms. For the fi rst
`time in many years, there were more patients
`taking AVONEX at the end of the year than at
`the beginning of the year.
`
`We also made considerable investments in
`TYSABRI®, our highly effective treatment for
`relapsing forms of multiple sclerosis. In January
`2012, the U.S. Food and Drug Administration
`(FDA) approved a product label change that
`identifi es anti-JCV antibody status as a risk
`factor for developing an infrequent but serious
`brain infection known as progressive multifocal
`leukoencephalopathy (PML). This label change
`was the foundation of our application to the FDA
`and European Medicines Agency (EMA) in early
`2013 requesting updates to the TYSABRI label
`for an expanded indication that would include
`fi rst-line use in patients who test negative for
`JC virus antibodies. It is our hope that TYSABRI
`will be approved for this patient population. We
`continue to conduct research, both internal
`and external, intended to identify further
`risk-stratifi cation tools.
`
`Also last year, we began a global Phase 3b
`study, ASCEND, to evaluate the effectiveness
`of TYSABRI as a treatment for secondary
`progressive multiple sclerosis (SPMS).
`
`Approximately 35 percent of MS patients have
`the secondary progressive form of the disease,
`and currently there is no effective therapy
`to treat them. Preliminary data from small
`observational studies suggest that TYSABRI
`may provide a benefi t to these patients, and we
`are testing that hypothesis in the ASCEND trial.
`
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`

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`In February 2013, we reached an agreement
`with our partner Elan to acquire full ownership
`of TYSABRI. This transaction, which closed in
`April 2013, is a pivotal event in our stewardship
`of TYSABRI that began even before launch
`in 2004. This acquisition provides us with a
`greater share of TYSABRI profi ts, operational
`and strategic control, and eliminates the change
`of control provision that was part of the original
`agreement. We believe full ownership also
`improves our ability to optimally position TYSABRI
`within our MS portfolio.
`
`From Pipeline to Patients
`The excellent performance of our marketed products
`portfolio was mirrored by the success of our R&D
`and regulatory organizations. 2012 was a year
`of signifi cant achievements, spanning the entire
`pipeline, from early research to clinical support for
`marketed therapies.
`
`I’ll start with our most recent accomplishment:
`TECFIDERA™ (dimethyl fumarate), a new fi rst-line
`oral treatment for people with relapsing forms of
`multiple sclerosis, including relapsing-remitting
`multiple sclerosis (RRMS), which is the most
`common form of this disease. In March 2013, the
`FDA approved TECFIDERA, and the Committee for
`Medicinal Products for Human Use issued a positive
`opinion recommending a marketing authorization be
`granted for TECFIDERA in the European Union.
`
`Results of our Phase 3 DEFINE and CONFIRM
`studies – which form the foundation for
`TECFIDERA’s regulatory fi lings around the world
`– were published in The New England Journal of
`Medicine in September, 2012.
`
`Additionally, in March 2013, the U.S. Patent
`and Trademark Offi ce issued us a patent for the
`TECFIDERA dosing regimen of 480 mg daily. This
`patent, which expires in 2028, adds to our growing
`portfolio of patents covering TECFIDERA, which
`includes patents claiming formulations of its active
`ingredient, dimethyl fumarate, to treat multiple
`sclerosis and methods for treating multiple sclerosis
`using dimethyl fumarate. Those patents will expire in
`2019 and 2020, respectively, but could be eligible
`for additional extension.
`
`In Europe, the European Patent Offi ce determined
`that our application for a patent covering the same
`480 mg daily dosing regimen of TECFIDERA
`is allowable. Once granted, this patent will also
`expire in 2028. The European Patent Offi ce has
`already issued a patent that covers the TECFIDERA
`formulation and the method of treating MS and
`other autoimmune diseases. This patent will expire
`in 2019 but may be eligible for term extensions in
`some countries.
`
`TECFIDERA offers the MS community a treatment
`with strong effi cacy and a favorable safety profi le in
`the convenience of a pill – a combination we believe
`will have a signifi cant, positive impact on the way
`people live with this chronic disease. TECFIDERA
`raises expectations for what patients can achieve
`with their therapy, and Biogen Idec is committed
`to setting a new standard for the next generation
`of medicines.
`
`We also continued to advance our late-
`stage development program for PLEGRIDY ™
`(peginterferon beta-1a) for the treatment of
`relapsing forms of MS. We reported positive top-
`line data from the Phase 3 registrational study in
`January 2013, and expect to fi le our Biologics
`License Application (BLA) with the FDA in mid-
`2013. If approved, PLEGRIDY is expected to
`represent an innovation that offers patients solid
`effi cacy, with a dosing schedule that compares
`favorably to the more frequent injection schedules
`with other drugs in the injectable class of treatment.
`We believe that convenience will be an increasingly
`important differentiator in this segment of the MS
`market, and that the less frequent dosing schedule
`of PLEGRIDY, with a convenient auto-injector,
`will allow us to capture an increasing share of this
`market segment.
`
`We also advanced daclizumab high-yield process
`(DAC HYP), an investigational, once-monthly
`subcutaneous therapy in the treatment of RRMS.
`We reported data from our Phase 2b SELECT trial
`at the American Academy of Neurology in April
`2012 and the full data set was recently published in
`an online article in The Lancet. In addition, we fully
`enrolled our Phase 3 DECIDE registrational clinical
`trial in mid-2012. We expect a read-out from this
`trial in 2014.
`
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`

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`As we intensify our commitment to MS, we are
`leading what we believe will be a transformation
`in the standard of care in hemophilia. In 2012,
`we reported positive clinical data from Phase
`3 trials for long-lasting recombinant factor VIII
`Fc fusion protein (rFVIIIFc) for the treatment of
`hemophilia A and long-lasting recombinant factor
`IX Fc fusion protein (rFIXFc) for the treatment of
`hemophilia B.
`
`These two therapies, the fi rst true innovations
`in hemophilia in two decades, have the potential
`to change the way people with hemophilia
`think about treatment – reducing the burden
`of treatment and improving long-term health
`outcomes at the same time. As of this writing,
`the FDA has accepted our BLA for marketing
`approval of rFIXFc, and we have submitted a
`BLA for rFVIIIFc. We anticipate launches for both
`therapies over the next 12 months.
`
`Early-stage Pipeline
`Biogen Idec advanced its early-stage pipeline
`in 2012 through identifi cation and validation
`of new targets, discovery of fi rst-in-class
`drug candidates, and business development
`agreements. We moved several compounds into
`Phase 1 and 2 clinical trials in neurodegenerative
`and immunological diseases. MS, Alzheimer’s
`disease, neuropathic pain, and lupus nephritis
`were among the diseases targeted in these
`studies, which include:
`
`• A Phase 2a study of our anti-LINGO molecule
`in acute optic neuritis. We expect to initiate a
`second Phase 2 trial of anti-LINGO in relapsing
`MS during the second half of 2013.
`• A Phase 2b study of anti-TWEAK, our
`monoclonal antibody in lupus nephritis.
`• A Phase 1b clinical trial for BIIIB037,
`our fi rst clinical study in Alzheimer’s disease.
`• A Phase 2a study of STX-100 in patients
`with idiopathic pulmonary fi brosis.
`
`We expect to initiate a Phase 2 study of
`neublastin for neuropathic pain in the
`coming months.
`
`In addition to these milestones, Biogen Idec
`signed three development agreements with Isis
`Pharmaceuticals (Isis), a leader in antisense, or
`RNA-targeted, drug discovery and development.
`Through these agreements we will:
`
`• Jointly develop and commercialize Isis’
`antisense investigational drug, Isis-SMNRx, for
`the treatment of spinal muscular atrophy (SMA)
`in children. Isis reported full data from a Phase
`1b clinical trial at the American Academy of
`Neurology meeting in March 2013;
`• Collaborate to develop and commercialize
`a novel antisense drug for the treatment of
`myotonic dystrophy type 1 (DM1), the most
`common form of muscular dystrophy in adults;
`and
`• Combine our resources to discover and develop
`antisense drugs against three undisclosed
`targets to treat neurological or neuromuscular
`disorders.
`
`Our relationship with Isis refl ects our respect
`for them as a partner. By combining Isis’
`knowledge of antisense science with Biogen
`Idec’s leadership in neurology, we believe these
`collaborations hold great potential for discovery
`and development of innovative approaches
`to treating neurological diseases.
`
`In 2012, our organization continued to build
`world-class science focused on some of the most
`heart-rending medical issues facing individuals.
`Our alignment and focus allow us to continually
`innovate and take on very complex patient
`challenges and push into disease areas where
`little or no therapy is currently available.
`
`This commitment to stellar biomedical research
`in the interest of serving people is refl ected in
`our only clinically unsuccessful project of 2012.
`In January 2013, we discontinued development
`of dexpramipexole, a compound that was being
`tested in people with amyotrophic lateral sclerosis
`(ALS). Dexpramipexole failed to meet any
`endpoints in a pivotal Phase 3 trial, either
`in the general study population or
`in multiple subpopulations.
`
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`

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`Mother, Dog Lover, Inspiration
`
`Meet Lisa Sindoni
`
`In 2007, Lisa Sindoni went to the ER with
`left-sided weakness, diffi culty fi nding words,
`and issues with hand-eye coordination. After
`several tests and opinions, doctors diagnosed
`Lisa with relapsing-remitting multiple sclerosis
`and recommended immediate treatment.
`
`Today, Lisa still mourns her lost abilities, but
`she has learned how to develop other abilities.
`With TYSABRI® on her side, Lisa engages in
`daily crosswords, Sudoku, and reading to help
`challenge her brain and coordination. When
`she can, she adds physical activity to her
`routine, including going to the gym, and doing
`yoga, Pilates, and ballet workouts via DVD.
`
`MS ActiveSource® Mentors have chosen to share their stories
`with other people living with MS.
`
`Each of these stories refl ects the personal experiences of one
`person, and stories are not intended to imply any therapeutic
`benefi t, results or experiences with Biogen Idec products.
`
`“The greatest lesson I learned
`from my diagnosis, and am
`constantly reinforcing, is that I
`have to think about what’s best for
`me. I spent my entire life taking
`care of others, both personally
`and professionally. I didn’t know
`how to take care of me.”
`
`Lisa gives back to others as a mentor in the
`Biogen Idec ActiveVoices™ (msactivesource.
`com) program, a mentoring program in which
`a newly-diagnosed patient is teamed with a
`“veteran” multiple sclerosis patient for support
`and assistance.
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`

`

`While this was terribly disappointing to everyone
`dedicated to helping the ALS community, we believe
`the dexpramipexole trial represents a signifi cant
`contribution to ALS research. One of the most
`comprehensive ALS studies ever conducted, the
`EMPOWER trial created a robust clinical database
`that we expect will provide an important contribution
`to future research and also established a novel
`endpoint for ALS that combines function and survival.
`
`Through EMPOWER, we developed criteria for early
`diagnosis and disease progression of ALS; we better
`characterized its epidemiology, medical co-morbidities
`and natural history; and we quantifi ed the impact
`of treatment based on changes in function. These
`innovations enabled us to contribute to an EMA white
`paper for ALS clinical development.
`
`Biogen Idec remains committed to
`advancing ALS science, and we are
`working with researchers around
`the world to further understand
`the disease.
`
`A Passion for Innovation
`In 2012, we established a research collaboration
`with Duke University and HudsonAlpha Institute for
`Biotechnology to sequence the genomes of up to
`1,000 people with ALS over the next fi ve years.
`This ambitious undertaking may lead to important
`new insights into the genetic causes of ALS.
`
`Additionally, just before the end of 2012, we
`announced the formation of a consortium in
`collaboration with several leading academic
`research centers to identify new approaches
`to treating ALS.
`
`The consortium, which includes some of the most
`renowned neuroscientists and ALS scientists in the
`world, is led by our chief scientifi c offi cer, Spyros
`Artavanis-Tsakonas, who joined Biogen Idec during
`2012 from his position as professor of cell biology
`at Harvard University. This research consortium is an
`innovative way for Biogen Idec to interact with world-
`class academic researchers to pursue a common
`goal of fi nding treatments for diffi cult-to-treat
`diseases. Diseases like ALS are complicated and it
`has proven very challenging to fi nd treatments.
`
`By combining our expertise with that of leading
`academic researchers, and assembling a
`complementary group of researchers, we hope to be
`able to make progress in defi ning the causes of ALS
`and ultimately in developing novel therapeutics to
`treat the disease.
`
`We have embraced academic collaborations as a part
`of our strategy to maintain a vibrant and innovative
`research organization and better understand the
`underlying biology of disease.
`
`Our research agreement with Harvard Medical
`School to produce the fi rst large-scale map of
`the human interactome is an excellent example
`of that strategy.
`
`This initiative is expected to provide an in-depth
`portrait of how proteins in the human body
`communicate and interact with each other, and
`promises to yield a wealth of new targets for
`potential therapies.
`
`With our partners in the hemophilia community, we
`created an initiative, My Life, Our Future: Genotyping
`for Progress in Hemophilia, to help uncover genetic
`information that can be used by physicians to
`individualize the care of people with hemophilia, as
`well as generate data that may lead to new scientifi c
`discoveries. This initiative fi ts perfectly with our
`mission because it offers knowledge to patients, their
`families, healthcare providers and researchers that
`can improve care and advance science.
`
`Preparing for
`Long-term Growth
`As I wrote to you in our 2011 annual report, the
`environment for biomedical innovation, patient care
`and the provision of health services remains in a
`period of dramatic change. We are undertaking
`several initiatives to help position us strongly in the
`evolving environment.
`
`We continue to navigate the challenging fi scal
`environment in major markets around the globe.
`Like others in the industry, in Europe we are wrestling
`with the realities of continuing economic pressures.
`Nations under severe fi nancial stress have taken
`measures that threaten healthcare and innovation.
`
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`

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`Student, Camp Counselor, Volunteer
`
`Meet Jetty Sapinoso
`
`2 0 1 2 B I O G E N I D E C H E M O P H I L I A S C H O L A R S H I P W I N N E R
`
`biogenidechemophilia.com
`
`Jetty is on a career path to become a dental
`hygienist – a natural choice considering that
`he’s always looking for opportunities to make
`people smile. According to Jetty, “Everybody
`has the ability to lend a helping hand. If people
`lived their lives doing one good deed a day, the
`world would be a better place.”
`
`Jetty has extended his hand to help the
`younger generation with hemophilia. He was
`once a camp counselor for the Hemophilia
`Foundation of San Diego and let the campers
`practice their vein-fi nding skills on him. Now,
`he wants to share his passion for healthy living
`with the younger generation to reinforce the
`importance of regular physical activity.
`
`“Parents are scared for their
`children to have bleeds. I want
`to promote being active without
`going overboard, so kids can
`build muscle.”
`
`Always looking to help others in need, Jetty
`tries to fi nd time to volunteer during his busy
`days that usually include working, exercising,
`and restoring cars to bring to the racetrack.
`
`Each of these stories refl ects the personal experiences of one
`person, and stories are not intended to imply any therapeutic
`benefi t, results or experiences with Biogen Idec products.
`
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`

`

`Even countries with healthier economies present
`a changing landscape for health technology
`assessments, particularly in key markets
`like Germany and the U.K. Despite these
`complexities, we have continued to be successful
`and grow our operations throughout Europe,
`and believe that we are well-poised to continue
`to do so.
`
`In the United States, we are preparing for the
`implementation of the Affordable Care Act and the
`changes it will bring to the healthcare landscape.
`We are also investigating the opportunities
`presented by the Food and Drug Administration
`Safety and Innovation Act (FDASIA), with
`the enhancement of the accelerated approval
`mechanism and the creation of the breakthrough
`therapy designation.
`
`Our R&D group has targeted medical problems
`that are diffi cult but that we believe are not
`intractable – and where our expertise can make
`a meaningful difference for patients. To support
`these efforts, we are building world-class
`capabilities in market access, health economics,
`and research and development to enhance
`scientifi c and real-world understanding of the
`diseases we seek to treat, with a goal
`of improving pipeline decisions and
`patient outcomes.
`
`Our mission is to discover and
`develop drugs that provide real
`value to patients and payors, and
`to generate the economic and
`outcomes data to support our
`value proposition.
`
`In the global marketplace, we are supplementing
`our core commercial operations in the U.S.
`and Europe with a robust strategy for entering
`emerging markets based on local needs and
`our ability to meet them. In the coming years,
`we expect to enter new and emerging markets
`through a strategy of “smart growth”: optimizing
`immediate opportunities while mitigating risks
`through a combination of distributor networks
`and direct investment, and staging expansion to
`participate appropriately now – while positioning
`ourselves to capture long-term potential.
`
`Our Pharmaceutical Operations and Technology
`(PO&T) organization is enhancing its already
`strong capabilities to focus on strategies to
`improve production effi ciency, strengthen supply
`chains and enable quality-of-life improvements to
`Biogen Idec therapies – such as improved dosing,
`user-friendly packaging and delivery systems that
`offer meaningful benefi ts to patients. Here are a
`few examples of these efforts:
`
`• We formalized our joint venture with Samsung,
`creating Samsung Bioepis. This joint venture
`leverages our expertise and capabilities in
`protein engineering, cell line development and
`recombinant biologics manufacturing to position
`the company to participate in the emerging
`market for biosimilars.
`
`• We completed construction on our Hillerød,
`Denmark, international manufacturing site
`and completed the FDA validation process for
`TYSABRI production in 2012. We expect to
`receive licensing to manufacture in 2013.
`Once licensed, this facility will perform large-
`scale manufacturing, packaging, labeling and
`quality control and assurance for products sold
`outside the U.S.
`
`• We opened a new facility in Research Triangle
`Park, North Carolina, which unites on one
`site more than 1,000 Biogen Idec employees
`dedicated to patient care – from manufacturing
`high quality therapies to providing patient
`services, including fi nancial assistance
`where necessary.
`
`• We created a strategic alliance with Eisai,
`Inc., to bolster our manufacturing capabilities
`in Research Triangle Park, North Carolina.
`This alliance expands our expertise in small
`and large molecule production and creates an
`additional manufacturing facility for TECFIDERA
`production. The agreement also provides us
`with the option to purchase the Eisai facility in
`the future.
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`

`

`Father, Mechanic, Patient Advocate
`
`Meet Willie Martin
`
`Willie was diagnosed with multiple sclerosis
`in March 2008. His fi rst symptoms included
`slurred speech, an inability to fi nish sentences,
`lack of balance when walking, blurred vision,
`and feeling anxious. His symptoms progressed
`quickly over a few days. After diagnosis, he
`chose to begin his therapy with AVONEX®
`because of the convenient once-a-week
`dosing schedule.
`
`Willie works as a machinist and enjoys drag
`racing. He is a crew member, builds cars,
`races every other weekend, and attends
`all-day events and car shows. He is also a
`volunteer and a patient advocate so he can
`help other people living with MS.
`
`“Life matured me so I can deal
`with problems and continue
`living. I have something to
`offer others, and I hope my
`experiences can help others
`in their journey living with
`multiple sclerosis.”
`
`MS ActiveSource® Mentors have chosen to share their stories
`with other people living with MS.
`
`Each of these stories refl ects the personal experiences of one
`person, and stories are not intended to imply any therapeutic
`benefi t, results or experiences with Biogen Idec products.
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`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 11
`
`

`

`Our Responsibility as a Global Citizen
`
`As Biogen Idec grows, we continue to invest deeply
`and strengthen our partnerships and support the
`communities in which we operate. We reinvigorated
`and restructured The Biogen Idec Foundation to
`ensure that our philanthropic efforts keep pace
`with our corporate growth. The result is that
`our foundation made a stronger impact on our
`communities through signifi cant programs. Biogen
`Idec made the following contributions through both
`foundation and corporate initiatives in 2012:
`
`• A $100,000 grant to Teach for America programs
`in Massachusetts and Eastern North Carolina in
`support of Science, Technology, Engineering, and
`Math (STEM) education.
`
`• A commitment of signifi cant funds to the University
`of Massachusetts Medical School ALS Champion
`Fund to increase awareness of ALS and support
`basic and clinical science research into potential
`treatments for ALS and other neurodegenerative
`diseases.
`
`• A renewed pledge of employee volunteerism and
`diversity through our Care Deeply Volunteer Day,
`designed to encourage Biogen Idec employees
`to give back to their local communities. From
`Zug, Switzerland, to Greater Boston, Care
`Deeply Volunteer Day annually draws over 1,100
`employees to assist more than 40 nonprofi t
`projects, logging some 3,500 hours.
`
`We also remain focused in support for education and
`public policy engagement to address the future of
`biomedical science at fundamental levels:
`
`• Through support for organizations such as the
`Museum of Science in Boston, the Museum
`of Life and Science in Durham, North Carolina,
`and the KinderUniversität Zurich, we have
`developed partnerships with organizations that
`inspire young people to gain an interest in
`science careers.
`
`• Our Community Lab facilitates the engagement
`of students in middle school and high school,
`to introduce scientifi c methods and experience
`hands-on, real-world science at our research
`facility. Our Cambridge, Massachusetts lab
`is considered the gold standard and in 2012
`celebrated 10 years of providing hands-on
`learning opportunities.
`
`• Our support of Room to Read has resulted in the
`building of two libraries and a school in Sri Lanka
`as well as the publication of a book in the local
`language of Nepal. By helping children become
`life-long learners with access to quality education,
`we believe we can pique their interest in science
`and innovation.
`
`• We underwrite organizations, such as the
`Biomedical Science Careers Program, which
`enables high-potential minority undergraduate and
`graduate students to complete their academic
`work and enter the science-based workforce.
`
`• We foster basic research at the highest
`intellectual levels through academic collaborations,
`partnerships, and programs such as the ALS
`Consortium noted above.
`
`• And we participate in the public discourse about
`the future of innovation. In fact, I am proud to note
`that Doug Williams, our R&D leader, and I had
`the privilege of providing input to the President’s
`Council of Advisors on Science and Technology,
`better known in public policy circles as PCAST
`– and Doug served as a formal member of the
`Council’s PCAST Drug Innovation Invited Experts.
`This year, Biogen Idec is one of three corporate
`supporters of the FDA-Aspen Institute initiative,
`National Strategy for Biomedical Innovations,
`which will integrate academia, industry and
`government to align scientifi c policy and priorities
`with society’s health needs.
`
`Individually these efforts are noteworthy but not unusual for a successful
`organization. Taken collectively, though, they represent an important investment
`in human capital and in the legacy that the current leadership of Biogen Idec will
`leave to future generations.
`
`10
`
`biogenidec.com/AR2012
`
`
`
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`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 12
`
`

`

`A Company Aligned. A Mission Defi ned.
`
`At the beginning of 2013, we fi nd ourselves
`with great opportunity and a clear mission.
`Our opportunity is based on a foundation
`driven by and rooted in great science, our
`focus on treatments that are enabling a better
`quality of life for patients challenged by some
`of the most diffi cult medical conditions, and a
`global organization that is fully aligned around
`our mission to clearly pursue opportunities
`within focused therapeutic areas. We are
`an organization that is wholly committed to
`attracting the best talent and the best leaders,
`while effectively responding to evolving
`regulatory and economic realities so we can
`work to deliver treatments to patients around
`the world in the most effi cient way possible.
`
`Biogen Idec has come off a solid year
`of revenue growth and profi tability, while
`advancing our late-stage pipeline and investing
`in upcoming product launches.
`
`We have kept our promises.
`
`But we know we have a lot of work to do to
`meet the opportunity that stands before us.
`
`With the foundation we have built, we are
`well-prepared for the leadership challenges
`ahead: attend to today’s business while
`preparing for tomorrow, and pursue a vision
`where Biogen Idec invests enthusiastically
`to prolong and improve lives, is valued for
`its contributions to society and generates
`sustainable returns for those who have
`invested resources in us. Regardless of what
`comes our way, our fundamental business
`belief remains unchanged: If we invest smartly
`in therapies that offer true benefi t to patients
`and market them thoughtfully, we will do well
`… and so will you, our shareholders.
`
`Sincerely,
`George A. Scangos, Ph.D.
`Chief Executive Offi cer
`
`
`
`43080.indd 1143080.indd 11
`
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`4/17/13 12:07 PM4/17/13 12:07 PM
`
`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 13
`
`

`

`APPROVED
`
`FILING
`
`PHASE 3
`
`PHASE 2
`
`PHASE 1
`
`PRODUCT PIPELINE
`
`Phase One
`
`CD40L
`Systemic Lupus Erythematosus
`
`BIIB037 (HUMAN ANTI-AMYLOID BETA MAB)
`Alzheimer’s Disease
`
`SMN
`RX
`Spinal Muscular Atrophy
`
`NEUBLASTIN
`Neuropathic Pain
`
`Phase Two
`
`OCRELIZUMAB (HUMANIZED ANTI-CD20 MAB)
`Multiple Sclerosis, Relapsing-Remitting
`
`ANTI-TWEAK
`Lupus Nephritis
`
`ANTI-LINGO
`Multiple Sclerosis
`
`STX-100
`Idiopathic Pulmonary Fibrosis
`
`Phase Three
`
`PLEGRIDY (PEGINTERFERON BETA-1A)
`Multiple Sclerosis, Relapsing Forms
`
`DACLIZUMAB
`Multiple Sclerosis, Relapsing Forms
`
`GA101 (HUMANIZED ANTI-CD20 MAB)
`Chronic Lymphocytic Leukemia
`
`GA101 (HUMANIZED ANTI-CD20 MAB)
`Non-Hodgkin’s Lymphoma
`
`TYSABRI (NATALIZUMAB)
`Secondary-Progressive MS
`
`12
`
`biogenidec.com/AR2012
`
`
`
`43080.indd 1243080.indd 12
`
`
`
`4/17/13 12:07 PM4/17/13 12:07 PM
`
`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 14
`
`

`

`APPROVED
`
`FILI

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