EVOLVING TO A SPECIALTY CARE BIOPHARMA COMPANY
`
`2013 Annual Report
`
`▲
`
`Dina Sienkiewicz, pictured here with her husband, Vinny, participated
`in an investigational clinical trial of the combination use of experimental
`immune-based therapies from Bristol-Myers Squibb.
`
`5asd
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`Page 1 of 114
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`AstraZeneca Exhibit 2115
`Mylan v. AstraZeneca
`IPR2015-01340
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`

`

`ON THE COVER
`
`After Dina Sienkiewicz, 46, of Woodbury, Connecticut (pictured here with her
`husband, Vinny), was diagnosed with stage 4 mucosal melanoma, a relatively rare
`type of cancer that invades mucosal surfaces of the body, she began to shorten
`her goals. “I just wanted to live long enough to see my daughter graduate high
`school and know that she was going off to college.”
`
`Now, three years later, her daughter is a college junior studying to be a physician’s
`assistant, and Sienkiewicz is on the Internet every night, trying to help her “cancer
`buddies,” who share her form of cancer.
`
`Her cancer had spread, even after two surgeries, and her surgeon admitted there
`was “no clear blueprint” for what to do next. That’s when Sienkiewicz went to see
`Dr. Mario Sznol, the clinical research program leader for the melanoma program at
`Yale Cancer Center in New Haven, Connecticut. He suggested she enter a clinical
`trial that was exploring whether an investigational therapy might turn on a switch in
`her immune system to help fight the cancer. She was given an investigational com-
`bination of two experimental immune-based therapies from Bristol-Myers Squibb:
`ipilimumab and nivolumab.
`
`After her first treatment, she developed an adverse reaction, an eye inflammation
`that would have to be resolved before determining whether she could continue
`on the trial. However, as she was healing, something remarkable occurred. “I
`went in for the first scans, and to everyone’s surprise, much of the cancer had
`disappeared,” she says. Eight weeks later, more scans showed that while she
`was not cured, there was no longer any evidence of the tumors.
`
`“Dr. Sznol said he hadn’t done anything – that it was the investigational drugs,”
`Sienkiewicz adds. “Yet he was always cautiously hopeful, and he and his team
`were there for me every step of the way. I’m a huge advocate of clinical trials now
`because they provide options for people. I never want anyone else to ever hear
`the words, ‘There is no clear blueprint.’”
`
`The patient stories shared in this Annual Report depict individual patient responses to our
`medicines or investigational compounds and are not representative of all patient responses.
`In addition, there is no guarantee that potential drugs or indications still in development will
`receive regulatory approval.
`
`AS THE EXTERNAL ENVIRONMENT continues to change –
`posing both challenges and opportunities – Bristol-Myers Squibb
`has successfully adapted and evolved. Throughout our history,
`this strategic resilience has allowed us to adhere to our Mission.
`Moreover, it has enabled us to keep pace with an ability to address
`the critical needs of today’s patients, while building a company
`that can create extraordinary possibilities for making a difference
`in the lives of people in the years ahead.
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`

`

`“ I just wanted to live long
`”
`
`enough to see my daughter
`graduate high school and
`know that she was going
`off to college.
`
`– Dina Sienkiewicz
`
`1
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`

`

`TO OUR STOCKHOLDERS
`
`MESSAGE FROM THE CHIEF EXECUTIVE OFFICER
`
`Bristol-Myers Squibb is a company on the move. Driving results.
`Building our future. Making a difference in people’s lives.
`
`the patient populations who could be served by this relatively
`new, increasingly popular cardiovascular medicine.
`
`Throughout 2013, we delivered across the board and across
`the globe. Commercially. Clinically. Strategically. We continued
`our balanced approach of delivering for patients today, while
`investing for patients tomorrow.
`
`We ended the year in a strong, forward-leaning position. Our
`financial performance was solid. Our pipeline was robust. And
`our BioPharma transformation entered into a new, exciting
`phase – one geared toward making us one of the industry’s
`leading specialty care companies.
`
`Simply stated, 2013 was an important year for Bristol-Myers
`Squibb.
`
`Driving Results
`
`Our total shareholder return was 70%, which was well above
`our peer average of 36%. We also met our goals with respect
`to earnings per share and sales.
`
`Our revenue was $16.4 billion, which represents a 7% decrease in
`company sales – a decline largely caused by the loss of exclusiv-
`ity of Plavix and Avapro in the U.S. the previous year – but each of
`our new and in-line products delivered strong, meaningful results.
`Among the key drivers with double-digit growth were Yervoy
`(metastatic melanoma), Sprycel (chronic myeloid leukemia),
`Orencia (rheumatoid arthritis) and Baraclude (hepatitis B).
`
`In fact, excluding Plavix and Avapro, we delivered a 9% increase.
`This is significant, because it underscores the strength of our
`current portfolio and the potential for sustained long-term growth.
`
`Much of our research and development focus in 2013 was in
`three therapeutic areas: cardiovascular, immuno-oncology
`and hepatitis C. We met our objective regarding the number of
`Phase III compounds and exceeded our goals regarding life-cycle
`management of our products. Additionally, we presented important
`clinical data and made key regulatory advances.
`
`Cardiovascular
`
`It was a very important year for Eliquis. We launched in major
`markets around the world for stroke prevention in atrial fibrillation,
`and sales trended positively throughout the year. And based on
`very favorable data, we filed in the U.S. and Europe for the treat-
`ment of venous thromboembolism, thus potentially expanding
`
`Immuno-oncology
`
`It was a very exciting year for our immuno-oncology platform
`because it became increasingly clear that our products have
`the potential to fundamentally transform cancer care – making
`it possible for patients to live longer, better lives.
`
`Our first immuno-oncology therapy, Yervoy, is now available in
`more than 40 markets and delivered a 36% increase in sales last
`year. We presented compelling long-term survival data for Yervoy
`in metastatic melanoma and advanced our work with nivolumab
`in multiple tumor types – metastatic melanoma, renal cancer and
`lung cancer. Nivolumab, which is also being studied both as a
`monotherapy as well as in combination therapy, is the subject of
`more than 30 ongoing clinical studies for a range of cancers.
`
`Hepatitis C
`
`And it was a very promising year for our hepatitis C portfolio.
`Our compounds continued to show real potential, particularly
`in Japan, where we filed our dual regimen late last year. In addi-
`tion, we submitted daclatasvir in Europe and initiated a Phase III
`study for a fixed-dose combination, which incorporates three
`of our oral agents in a single tablet.
`
`Building Our Future
`
`While driving these results, we also continued building our com-
`pany’s future – moving our transformation forward, maintaining
`the momentum of the past few years.
`
`In fact, since 2007, we have executed against a BioPharma
`strategy that has effectively turned Bristol-Myers Squibb into an
`industry leader. We have focused our resources on innovative
`pharmaceuticals. We have strengthened our pipeline and port-
`folio and diversified our geographical emphasis. And we have
`constantly evolved our organization to meet the challenges
`and opportunities of an ever-changing external environment.
`
`It was in that spirit that we announced in December our decision
`to sell the diabetes business of Bristol-Myers Squibb which
`comprised our global alliance with AstraZeneca – an important
`decision that was taken after a thorough assessment of the
`benefits it will generate for our company. It was also in that
`spirit that we sharpened our company’s R&D strategic focus to
`a more specialty care model.
`
`2
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`

`“
`
` Bristol-Myers Squibb is
`a company on the move.
`Driving results. Building our
`future. Making a difference
`in people’s lives.
`
`– Lamberto Andreotti, Chief Executive Officer”
`
`Taken together, these developments allow us to target our
`resources in a way that benefits our shareholders and the
`patients we serve. We are now able to invest more time, energy
`and money in those specialty areas where we can compete most
`effectively and can have a greater impact, such as immuno-
`oncology, virology including hepatitis C, rheumatoid arthritis
`and stroke prevention.
`
`To support this new model, we strengthened our Commercial
`organization by making it more global, more integrated and more
`streamlined. We also strengthened our Finance organization by
`integrating it with Strategy and Business Development – a move
`that will enhance our ability to align the long-term priorities of
`our company.
`
`Additionally, we made several key changes to my Senior
`Management Team. Francis Cuss became our Executive Vice
`President and Chief Scientific Officer. Giovanni Caforio became
`our Executive Vice President and Chief Commercial Officer.
`Anne Nielsen became our Chief Compliance and Ethics Officer.
`The responsibilities of Chief Financial Officer Charlie Bancroft
`expanded to include Strategy and Business Development.
`And we welcomed Ann Powell Judge, Senior Vice President
`for Human Resources.
`
`Making a Difference
`
`Throughout the year, we maintained our singular focus on people
`– those who use our medicines, those who live in our communi-
`ties and those who call Bristol-Myers Squibb home. Whether we
`were driving results or building our future, everything we did in
`2013 was centered on making a difference in people’s lives.
`
`Additionally, our commitment to people was the driving force
`behind the Bristol-Myers Squibb Foundation’s work in Africa
`
`(HIV/AIDS, tuberculosis, cervical cancer), Asia (hepatitis B
`and C), North America (diabetes, cancer and returning veterans)
`and Europe (cancer).
`
`Our commitment to people was the reason for our continued
`work in support of the United Nations Global Compact princi-
`ples, our significant progress toward the Bristol-Myers Squibb
`Sustainability 2015 Goals and our own “Go Green” initiatives
`at our sites around the world.
`
`And our commitment to people was at the heart of all we did
`to maintain a workplace that promotes diversity and inclusion
`and provides an atmosphere conducive to personal growth
`and professional development.
`
`Going Forward
`
`2014 promises to be another important year.
`
`We will continue to drive results. We will continue to build our
`future. We will continue to make a difference in people’s lives
`by providing new hope for our patients, new initiatives for our
`communities and new opportunities for our employees.
`
`And we will do all of this while maintaining our steadfast
`commitment to business ethics and personal integrity.
`
`This is who we are. This is what we do. This is Bristol-Myers
`Squibb today.
`
`Lamberto Andreotti
`Chief Executive Officer
`March 5, 2014
`
`3
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`

`“
`
`I am excited for our future. We have a
`strong portfolio. We have a promising
`new product pipeline. And we have an
`organization of people who continuously
`demonstrate their commitment to
`excellence and their ability to deliver.
`
`– James M. Cornelius, Chairman”
`
`MESSAGE FROM THE CHAIRMAN OF THE BOARD
`
`You can feel the excitement throughout Bristol-Myers Squibb.
`Our company is strong. The Board believes our future is bright.
`
`Since the inception of our BioPharma transformation in 2007,
`we have undertaken significant changes. We have sharpened
`our focus and targeted our resources. We have streamlined
`our operations and enhanced our agility. And through it all, we
`have strengthened our ability to fulfill our Mission “to discover,
`develop and deliver innovative medicines that help patients
`prevail over serious diseases.”
`
`Now, as we evolve to a specialty care company, we are taking
`the next step in this journey and taking our transformation to the
`next level. More than ever, we will now be able to focus on those
`products that can bring the greatest value to our patients.
`
`This is a significant development – one that is good for our
`company and good for the patients we serve.
`
`Although change is not always easy, it is often necessary, and
`over the years, our ability to change has been one of our strategic
`advantages. Bristol-Myers Squibb has long been the company
`that looks ahead, anticipates challenges and opportunities, and
`adapts accordingly. We did this in 2007. We continued doing
`this in 2013.
`
`That said, our ability to stay true to our strategic framework and
`Mission has been equally important. We have remained firmly
`rooted in our foundation of innovation, continuous improvement
`and selective integration. And we have remained firmly commit-
`ted to the patients at the center of everything we do.
`
`Understandably, I am proud of all that we have accomplished
`during the past year. Sales of our new and in-line products
`
`remained strong. Clinical and regulatory advances built momen-
`tum. Organizational improvements continued. And by the end
`of the year, we were well on our way to becoming the industry’s
`leading specialty care company. In addition, we welcomed two
`new members to our Board of Directors, Dinesh C. Paliwal,
`Executive Chairman, President and CEO of Harman International
`Industries, Inc., and Thomas J. Lynch, Jr., M.D., Director, Yale
`Cancer Center, and Physician-in-Chief, Smilow Cancer Hospital.
`
`Understandably, too, I am excited for our future. We have a strong
`portfolio. We have a promising new product pipeline. And we
`have an organization of people who continuously demonstrate
`their commitment to excellence and their ability to deliver.
`
`I am grateful to CEO Lamberto Andreotti and his Senior
`Management Team for providing the leadership needed to
`transform Bristol-Myers Squibb into a benchmark BioPharma
`company – one positioned for sustained long-term growth. And
`I am grateful to and proud of our more than 24,000 employees,
`who make it possible for us to do what we do best – deliver
`hope to patients worldwide.
`
`Thank you.
`
`James M. Cornelius
`Chairman
`March 5, 2014
`
`4
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`

`EVOLVING TO A SPECIALTY CARE
`BIOPHARMA COMPANY
`
`AT BRISTOL-MYERS SQUIBB, we have long understood
`that our success in making a difference in people’s lives is
`a reflection of our ability to evolve and reinvent ourselves. At
`the same time, we have also understood the importance of
`staying true to our values and to the strategies that allow us to
`advance our company and our Mission: to discover, develop
`and deliver innovative medicines that help patients prevail
`over serious diseases.
`In this Special Report, we will explore important changes
`we are making to meet the challenges and opportunities of
`a dynamic global external environment. We have realigned
`our Commercial, Finance and Manufacturing organizations
`to support our evolution to a specialty care business model.
`We have evolved our R&D strategic focus, product portfolio,
`pipeline and technology platforms to continue to address high
`unmet medical needs while better positioning us for long-term,
`sustainable growth. As part of that evolution, in early 2014, we
`divested our diabetes business to AstraZeneca. And we are
`significantly increasing our commitment to immuno-oncology,
`an emerging area of science in which we have pioneered and
`that offers great promise for patients and their families. We
`have also expanded our efforts in targeted oncology agents,
`as well as in HIV/AIDS, rheumatoid arthritis, stroke prevention
`and hepatitis C.
`All these efforts will allow us to build on a strategic foundation
`first introduced in 2007 that rests on three pillars: innovation,
`selective integration and continuous improvement. These will
`enable us to better serve our Mission, bring innovative thera-
`pies to our patients and accelerate our evolution to a specialty
`care BioPharma company.
`
`▲
`
`Miho Oyasu, Ph.D., examines the ability of a monoclonal
`antibody developed at the company’s Redwood City,
`California, biologics research facility, to bind to – and
`potentially target – gastric cancer cells.
`
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`EVOLVING OUR BUSINESS
`
`SPECIALTY MEDICINES generally are used to treat serious or life-threatening conditions. Often, they are most
`prescribed by medical specialists, including oncologists, infectious disease experts, rheumatologists and
`cardiologists, and may require hospital-based interventions. In order to bring specialty medicines to market
`effectively, they require a highly focused and highly skilled commercial organization.
`
`In late 2013, Bristol-Myers Squibb announced the creation of a single, fully integrated global Commercial
`organization that would be able to better support our evolving specialty care product portfolio and pipeline. Its aim
`is to be consistently superior in executing our commercial strategy across each brand and geographical location.
`
`Changes were also announced to better align and focus the Global Finance, Strategic Planning, and Business
`Development groups, along with Enterprise Services and Global Manufacturing and Supply.
`
`These changes are creating a more focused company, concentrated on a smaller number of core assets and
`priorities. This focus will enable R&D and Medical Affairs to better partner and align efforts with the Commercial
`organization. The aim is to develop and execute a global commercialization strategy for each product, while
`sharpening execution at the country level. In order to better serve payers, physicians and patients, we will rely
`on new cooperative models among our marketing, medical and access teams.
`
`As always, our shared focus is to ensure that more patients have access to our current product portfolio, as well
`as future medicines that emerge from our robust pipeline.
`
`LEVERAGING OUR CURRENT GROWTH DRIVERS FOR THE LONGER TERM
`
`AS WE CONTINUE to develop a robust
`pipeline of new, innovative specialty care
`products for patients in immuno-oncology
`and targeted oncology therapies, cardio-
`vascular conditions like stroke and heart
`failure, rheumatoid arthritis and other
`immune disorders, fibrotic diseases, and
`viral diseases including hepatitis C and
`HIV/AIDS, we are also focusing on sus-
`taining and accelerating the momentum
`of many of our current drivers of growth.
`
`Yervoy
`
`Yervoy (ipilimumab) represents the
`company’s first immuno-oncology
`therapy and is in a new class of therapies
`that works by harnessing the patient’s
`immune system to fight cancer. Since its
`launch, Yervoy has had a major impact
`on the management of many patients
`with advanced melanoma. The product
`is currently marketed and reimbursed in
`more than 40 markets around the world,
`and a growing number of physicians
`
`have adopted it based on the potential
`for durable long-term survival, consistent
`with an expanding body of emerging
`clinical data. In 2013, Yervoy revenues
`grew 36% globally. In September 2013,
`a pooled analysis of survival data from
`12 studies conducted in advanced
`melanoma patients demonstrated a
`three-year estimated survival rate of 22%,
`with some patients still alive and being
`followed for up to 10 years. In the fourth
`quarter of 2013, Yervoy received approval
`in the E.U. for first-line use in advanced
`melanoma, further expanding the number
`of patients who may potentially benefit.
`The company is building on the long-term
`data that have been seen with Yervoy to
`potentially enable more patients to benefit
`from a combination of immune check-
`point inhibitors. Yervoy also continues to
`be studied in adjuvant melanoma as well
`as a number of other cancers, either as
`monotherapy or in combination with other
`
`agents. While results presented in the fall
`of 2013 from the first Phase III trial testing
`Yervoy in an advanced form of prostate
`cancer did not meet the primary endpoint
`of overall survival, antitumor activity was
`observed in other efficacy endpoints, and
`the results in this advanced population
`support the potential role of immune-
`based therapies for prostate cancer. A
`second large trial of Yervoy in patients
`with less advanced disease is ongoing.
`Yervoy trials are also ongoing in lung,
`renal, gastric and ovarian cancers. (See
`more on immuno-oncology on page 12.)
`
`Eliquis
`
`Eliquis (apixaban) was initially approved
`in 2011 in the E.U. to prevent venous
`thromboembolic events (VTEs) following
`elective hip and knee replacement surger-
`ies. Then in late 2012, the product gained
`approval in most major markets around
`the world to reduce the risk of stroke
`and systemic embolism in patients with
`
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`

`Yervoy (ipilimumab), approved for use in metastatic melanoma,
`is packaged at a Bristol-Myers Squibb manufacturing facility
`in Anagni, Italy, about 60 miles southeast of Rome, and distrib-
`uted in more than 40 countries around the world. In addition to
`its current indication, Yervoy is being studied as monotherapy
`and in combination with other agents in prostate, lung, renal,
`gastric and ovarian cancers, as well as adjuvant melanoma.
`Yervoy works by inhibiting the CTLA-4 checkpoint pathway in the
`immune system. CTLA-4 normally helps keep immune system
`cells in check. By blocking its action, Yervoy helps the body’s
`immune system by increasing activated T cells, mobilizing them
`to attack the tumor.
`
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`Potential New Uses for Eliquis
`
`Venous thromboembolism (VTE), which includes deep vein thrombosis
`(DVT) and pulmonary embolism (PE), is a major source of morbidity
`and mortality, affecting about 900,000 patients in the U.S. and about
`1 million patients in the E.U. each year. DVT is a disease characterized
`by the presence of blood clots in the deep veins. And while DVTs can
`cause pain and swelling, they become dangerous when a piece of the
`clot breaks off and becomes lodged in the lung. There they can cause
`chest pain, shortness of breath or even sudden death. Eliquis, a Factor
`Xa inhibitor that prevents clots from forming, is currently being reviewed
`by regulatory authorities as a potential treatment for VTEs based on two
`Phase III trials, AMPLIFY and AMPLIFY-EXT. Eliquis is already approved
`in many global markets for use in certain patients with atrial fibrillation
`to prevent stroke and in the E.U. and other countries around the world for
`the prevention of VTEs following hip and knee replacement surgeries.
`
`Dr. Giancarlo Agnelli, a professor of medicine at the University of Perugia,
`Italy, was the principal investigator for both trials. “In AMPLIFY we looked
`at patients with confirmed DVTs or PEs. They were randomized to the
`current standard of care – an initial subcutaneous administration of
`enoxaparin for about one week, along with daily doses of warfarin – for
`six months, or to Eliquis,” he says. From an efficacy point of view, Eliquis
`was comparable to the standard of care, though potentially more con-
`venient, he says, because it was an all-oral regimen without the need for
`dose adjustment. “From a safety point of view,” Agnelli adds, “in these
`clinical trials Eliquis showed a 70% reduction in major bleeding when
`compared with the standard of care.”
`
`After the initial treatment of VTE for six months to 12 months, physicians
`are faced with a great challenge in deciding whether or not to stop the
`blood thinner. AMPLIFY-EXT addressed this question. Patients were
`randomized to two different doses of Eliquis or placebo for another year.
`As Agnelli notes, “We found there was a high risk of VTE recurrence in
`patients given no treatment. But when treated with Eliquis, that risk was
`reduced by 80%. In addition, at the lower dose, the same dose used to
`prevent clots after orthopedic surgery, Eliquis had rates of bleeding that
`were comparable to placebo.”
`
`imatinib achieved what is considered an optimal molecular
`response. This information is important because patients who
`achieved these responses may have improved overall survival
`and progression-free survival. Additionally, new three-year safety
`and efficacy data for newly diagnosed patients and five-year
`data for patients resistant to imatinib were recently added to
`the U.S. label. Sprycel remains a convenient, once-daily treat-
`ment. Since its initial U.S. Food and Drug Administration (FDA)
`approval in 2006, more than 175,000 Sprycel prescriptions have
`been written in the U.S. alone. Revenues worldwide increased
`by 26% in 2013. Seeking to add benefit to more patients, we
`are currently conducting Phase I studies adding Sprycel to an
`immune-based therapy, which may have the potential to provide
`an even more durable response than Sprycel alone.
`
`•
`
`nonvalvular atrial fibrillation, the most common cardiac
`arrhythmia. Eliquis remains the only drug in its class to
`have shown superiority to warfarin, the long-held standard
`of care, for stroke and systemic embolism, major bleeding
`and mortality. In late 2013, additional submissions were
`accepted in the U.S. and E.U. for the use of Eliquis for the
`treatment of venous thromboembolism. In the U.S., regu-
`latory authorities are also considering our submissions for
`its use in reducing the risk of potentially dangerous clots
`following elective hip and knee replacement surgery. Com-
`mercialization efforts in support of Eliquis are focused on
`cardiologists and hospitals, as well as certain primary care
`physician segments across markets. Increased emphasis
`on medical education has helped inform physicians about
`the product’s profile, while new direct-to-consumer adver-
`tising in the U.S. is educating patients about this important
`treatment option.
`
`Sprycel
`
`Sprycel (dasatinib) continues to leverage its first-line
`indication to treat patients with Philadelphia chromo-
`some-positive chronic phase chronic myeloid leukemia
`(CML). Supporting this effort are newly released data from
`a Phase III trial comparing Sprycel to imatinib presented
`in late December 2013. The data demonstrated that
`after four years of treatment, 76% of patients treated with
`Sprycel, compared to 63% of patients treated with imatinib,
`achieved a major molecular response, and 84% of patients
`treated with Sprycel versus 64% of patients treated with
`
`8
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`

`Orencia
`
`Increasingly physicians who treat patients
`with rheumatoid arthritis (RA) recognize
`and value the efficacy and safety profile of
`Orencia (abatacept) and its use as first-line
`biologic therapy for patients with moderate
`to severe RA. A subcutaneous formula-
`tion is helping accelerate the product’s
`growth in key global markets, including the
`U.S., providing an option for patients to
`self-administer the drug through injection
`instead of requiring travel to special infusion
`centers. The brand grew 23% worldwide
`in 2013. Orencia is also being studied in
`Phase III trials for potential use in lupus
`nephritis and psoriatic arthritis. In mid-2013,
`we announced a partnership with Simcere,
`a leading pharmaceutical company in
`China, to co-develop and co-commercialize
`the RA indication for Orencia in China.
`
`Baraclude
`
`Baraclude (entecavir) remains the global
`market leader in oral treatments for hepatitis
`B. For example, even in a highly competitive
`marketplace such as Japan, more than 90%
`of all naïve patients (those who have never
`received previous treatment for hepatitis B)
`are prescribed Baraclude. The product is
`also extensively prescribed in China
`and remains the number one pharmaceu-
`tical product in Taiwan and South Korea.
`Baraclude achieved worldwide revenue
`growth of 10% in 2013, even in the face of
`generic competition in key markets such as
`China, the world’s largest hepatitis B market.
`
`HIV/AIDS
`
`With its long history in developing and
`commercializing antivirals to treat HIV/AIDS
`dating back to the earliest days of the pan-
`demic, Bristol-Myers Squibb continues to be
`recognized as a market leader in virology,
`an increasingly competitive therapeutic area
`and market. We are exploring new ways to
`attack HIV and help make treatment simpler
`for patients. Meanwhile, we continue to
`focus on those patients who can continue to
`benefit the most from our existing therapies
`(Reyataz, Atripla and Sustiva). For example,
`Reyataz (atazanavir) is recommended in
`U.S. government treatment guidelines as
`part of a combination regimen for use in
`
`treatment-naïve adults and adolescents,
`as well as for pregnant HIV-infected
`women. Atripla (efavirenz/emtricitabine/
`tenofovir disoproxil fumarate), where we
`partner with Gilead, focuses primarily on
`naïve patients who can benefit from this
`one tablet-a-day regimen. In fact, Atripla
`remains the number-one-prescribed
`single-tablet HIV regimen in the U.S.
`Sustiva (efavirenz) was approved in the
`
`U.S. first as a once-daily medication and
`later within a single-tablet regimen as a
`component of Atripla. September 2013
`marked the 15th anniversary of the initial
`approval of Sustiva. Its development con-
`tinues, with FDA approval of an extended
`pediatric indication. The product is now
`available with a special “capsule sprinkle”
`method of administration for patients who
`can’t swallow capsules or tablets.
`
`THE DIABETES DIVESTITURE
`
`IN LATE DECEMBER, Bristol-Myers Squibb took an important step to advance the
`company’s BioPharma strategy and evolve to a specialty care business model.
`The company announced that it would divest its global diabetes business that was
`part of its collaboration with AstraZeneca. This important milestone enables the
`company to increase investment in our most significant opportunities and achieve
`our mission of discovering, developing and delivering innovative medicines that
`help more patients prevail in their fight against serious diseases.
`
`The transaction, which closed on February 1, 2014, provides significant value
`to Bristol-Myers Squibb and allows us to further accelerate the evolution of our
`business model. The divestiture of the business to AstraZeneca included initial
`compensation of approximately $2.7 billion upon closing the transaction, with
`potential regulatory and sales-based milestone payments of up to $1.4 billion,
`royalties on net sales through 2025 and payments of up to $225 million if and when
`certain assets are transferred to AstraZeneca. Most of the approximately 4,000
`company employees devoted to diabetes have been transferred to AstraZeneca,
`while Bristol-Myers Squibb R&D will continue to support certain ongoing diabetes
`clinical trial programs. A manufacturing and supply agreement also is in place.
`
`The agreement to sell the diabetes business was announced just a few weeks
`before the approvals of Farxiga (dapagliflozin), a novel SGLT2 inhibitor to treat type
`2 diabetes, in the U.S. (previously approved as Forxiga in Europe in November
`2012) and Xigduo (combining dapagliflozin and metformin), for use in improving
`glycemic control, in Europe. These new medicines add to the portfolio of diabetes
`products that AstraZeneca will carry forward and from which Bristol-Myers Squibb
`will earn royalties as part of the deal structure.
`
`The agreement will free up significant resources for Bristol-Myers Squibb to
`invest in numerous growth opportunities in specialty care, including Eliquis,
`potential new hepatitis C compounds and immuno-oncology. It will also increase
`the company’s financial flexibility, with new funds available for capital allocation
`priorities, especially external business development. And it provides an important
`opportunity to simplify the company’s operating model consistent with its pipeline
`and portfolio, by allowing us to focus more fully on specialty care products and
`leverage a more specialty care-oriented business model. Specialty care business
`models focus on disease areas of significant unmet medical need that are typically
`treated by physicians who specialize in a specific disease or therapeutic area, as
`opposed to general practitioners or primary care physicians.
`q
`
`9
`
`2013 Bristol-Myers Squibb Annual Report
`
`Page 11 of 114
`
`

`

`Help to Enjoy the “Little Things” in Life
`
`Growing up in Bridgeport, Connecticut, Lucy Medina was a