Bristol-Myers Squibb - 2018 Annual Report

At Bristol-Myers Squibb we come to work every day with one mission in mind: to discover, develop, and deliver transformational medicines to help patients facing serious diseases. This is what we do. This is who we are.

In 2018, performance was strong across the company and created great momentum for our business. We expanded the indications of our oncology portfolio with the important approval of Opdivo plus low-dose Yervoy for the treatment of renal cell carcinoma (RCC) in the U.S. and Europe. We reached an important milestone with Eliquis in the U.S., taking a leadership position in the prevention of stroke for patients with atrial fibrillation. We advanced a broad and deep pipeline in oncology, cardiovascular disease, fibrosis, and immunoscience. And we continued our efforts to be a good global citizen through our green initiatives, by investing in our local communities, and by supporting those in need.

2018 Results

2018 was marked by outstanding commercial execution. We ended the year with $22.6 billion in revenues – a nine percent increase over 2017. This was due to growth in nearly all of our priority medicines. Our results translate directly into more medicines delivered to more patients. Our strong operating performance resulted in 2018 GAAP earnings per share of $3.01 and Non-GAAP earnings per share of $3.98, which represents year-over-year growth of 32 percent.

Transforming cancer care remains a priority for our company as we focus on increasing survival rates for more patients across a greater range of tumor types. Our oncology franchise performed well in highly competitive markets, with Opdivo now approved in nine tumor types in 17 indications. In 2018, Opdivo revenue grew by 36 percent, ending the year with $6.7 billion in global sales. Opdivo continues to maintain and grow its market share in its approved indications while expanding into new tumors and earlier lines of therapy. We saw significant growth from the launch of Opdivo in adjuvant treatment in melanoma and the approval of Opdivo plus low-dose Yervoy for the treatment of first line RCC in the U.S. Additionally, Opdivo plus low-dose Yervoy were approved by the European Medicines Agency for first line RCC in January 2019, further expanding our Immuno-Oncology (I-O) combination therapy as a treatment option for patients with RCC in markets across Europe.

Opdivo distinguished itself as the first Immuno-Oncology therapy approved in China in 2018. This milestone is a tribute to the focused efforts of our teams in both the U.S. and in China to ensure speed in delivering this important medicine to cancer patients in China.

Eliquis continued to grow in the U.S. and internationally, with revenues totaling $6.4 billion, representing a 32 percent increase over 2017. In 2018, we achieved a major milestone when new prescriptions for Eliquis surpassed warfarin, the previous standard of care for stroke prevention in atrial fibrillation, to become the number one prescribed oral anti-coagulant in the U.S. Eliquis continues to be the leading novel oral anti-coagulant globally for stroke prevention in patients with atrial fibrillation.

The Eliquis clinical profile is supported through our continued investment in real-world data analysis. In 2018, we published the ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) study, which now includes more than one million patient records, and is the largest body of real-world evidence in existence for analyzing the effectiveness and safety of anticoagulants, including Eliquis, among patients with non-valvular atrial fibrillation and venous thromboembolism.

I am very proud that this medicine was discovered and developed by Bristol-Myers Squibb scientists, three of whom received the prestigious 2018 Sir James Black award from the British Pharmacological Society for their contributions in the discovery of Eliquis.

Delivering for tomorrow

The scientists of Bristol-Myers Squibb understand the urgent needs of patients for new treatment options. They are hard at work on the next generation of transformational medicines for patients as we continue to invest in the research and development of new treatment options to address significant unmet medical needs.

In 2018, we made significant progress in advancing our Innovative Medicines pipeline, which includes clinical programs in immunoscience, fibrosis, and cardiovascular disease. Results from the Phase 2 study of our selective TYK2 inhibitor for the treatment of moderate to severe plaque psoriasis were published in the New England Journal of Medicine in September, and registrational trials in this indication are well underway. We continue to advance our fibrosis portfolio with our lead compound in the area, FGF21, for the treatment of nonalcoholic steatohepatitis (NASH), which is currently enrolling a Phase 2b trial. In heart failure research, our nitroxyl donor asset is currently in Phase 2 trials and we look forward to data readouts in the coming year. Additionally, we signed a collaboration agreement with Janssen Pharmaceuticals for the development of our Factor XIa inhibitor for secondary stroke prevention and initiated a Phase 2 trial.

Our broad development program in oncology includes the important and growing body of work in translational medicine, giving us greater insights into which patients can benefit the most from our medicines. In 2018, we opened a new research center in Cambridge, Massachusetts to focus on resistance to treatment with current Immuno-Oncology agents, and we look forward to leveraging the rich scientific ecosystem of the location to drive innovation in this field.

Our clinical programs are focused on expanding the benefits of our Immuno-Oncology portfolio and moving into earlier lines of therapy, including the adjuvant setting which follows surgery to prevent recurrence.

In 2019, we expect to see a number of data readouts from our lung cancer program as well as from studies of Opdivo for the treatment of glioblastoma, head & neck, liver and renal cancers. Starting in 2020, we will begin to see results from studies of adjuvant treatment that will bring greater understanding of the role of Opdivo in earlier stages of disease. These will include results in adjuvant melanoma, bladder, and esophageal cancers next year with results in other tumors such as renal, liver, and lung cancers coming in subsequent years.

With innovation as our focus, we believe that tomorrow’s medicines will come from our own internal efforts as well as the rich ecosystem of scientific innovation that exists outside our company. In 2018, our business development teams were hard at work to find those medicines. This year, we entered into a global strategic collaboration to jointly develop and commercialize Nektar Therapeutics’ lead Immuno-Oncology program, NKTR-214, in combination with Opdivo and Opdivo plus Yervoy. The Nektar program provides Bristol-Myers Squibb with a third validated mechanism in Immuno-Oncology, providing us the opportunity to build on our experience with Opdivo and Yervoy.

In January 2019, we announced a definitive merger agreement for the planned acquisition of Celgene Corporation.¹ The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach.

Delivering for Underserved Communities

Throughout the year, the Bristol-Myers Squibb Foundation continued to build capacity and expand access to care for underserved populations by supporting innovative programs to train health care providers and mobilize communities in the fight against disease.

This effort included extensive programs in the U.S. to remove barriers and increase access to specialized care for vulnerable populations, improve lung cancer awareness and care, and support the reintegration of our returning veterans and their families. It also included significant innovations in access to cardiovascular care.

The Bristol-Myers Squibb Foundation is also working to bring quality cancer treatment to African communities, focusing on cervical and lung cancer in southern and east Africa, and pediatric cancers in southern and east Africa and west Africa. Leveraging the extensive learnings from 20 years of its “Secure the Future” program, the first and largest private initiative to address HIV and AIDS in southern and east Africa, the Foundation is working with community partners to promote cancer screening, train healthcare providers, and change the outcomes for cancer patients. Following the launch of Project ECHO for cancer in the U.S., the Foundation is funding an expansion of the tele-mentoring program to rural hospitals in South Africa.

We recognize that helping to improve access to our medicines is of critical importance to ensure all patients benefit from our innovations. Through the Bristol-Myers Squibb Patient Assistance Foundation, under- or uninsured patients, or those facing financial hardships, are able to obtain the medicines they need to fight serious disease.

Our commitment to good citizenship extends beyond medicines to communities impacted by natural disasters. This year again brought devastation through wildfires in California, hurricanes in North Carolina and Florida, floods and landslides in Japan, and an earthquake and tsunami in Indonesia. The Bristol-Myers Squibb Foundation responded quickly with cash donations to its disaster relief partners to provide essential supplies, and the company donated much-needed products to help impacted communities.

We continued our work with the United Nations Global Compact, as well as our “Go Green” activities at Bristol-Myers Squibb sites to promote sustainability. Our environmental programs were recognized with an “Energy Star Partner of the Year” Sustained Excellence Award for our four consecutive years of efforts to improve the energy efficiency of facilities worldwide.

Global Diversity & Inclusion

People & Business Resource Groups

Our People and Business Resource Groups (PBRG) leverage the diverse experiences and perspectives of our employees and drive transformative business results.

Strengthening Our Company Culture

At Bristol-Myers Squibb, we have the best and the brightest people and they fuel our success. It is through their hard work and commitment that we are able to realize our mission to help patients fighting serious disease.

We are committed to creating and sustaining a strong culture of inclusion to foster a highly innovative work environment. Our People and Business Resource Groups (PBRGs) leverage the diverse experiences and perspectives of our employees and drive transformative business results. In 2018, members of our PAN Asian Network partnered with our R&D organization in China to launch a global buddy system designed to mentor colleagues new to clinical development in China, resulting in the accelerated launch of Opdivo. Additionally, our LGBTA PBRG introduced a set of transgender guidelines in the U.S. to ensure a respectful and inclusive workplace environment for employees in the process of gender transition.

Embedded throughout our culture is a deep commitment to integrity and uncompromising ethics. We work to ensure that the highest ethics and integrity are at the foundation of all we do and how we do it.

Looking Forward

At Bristol-Myers Squibb, we are looking forward to an exciting future. We will build on the strong foundation of 2018 to grow our business and to help more patients. We have great medicines. We have great people. By focusing on patients and their families, and by demanding the very best from our people, the possibilities are endless. We will continue to create value for our patients, our shareholders, and our employees. This is why I am very excited for our future.

Thank you.

Giovanni_Signature-2016

Giovanni Caforio, M.D., Chairman of the Board and Chief Executive Officer

¹ The transaction is subject to approval by Bristol-Myers Squibb and Celgene shareholders and the satisfaction of customary closing conditions and regulatory approvals. Bristol-Myers Squibb and Celgene expect to complete the transaction in the third quarter of 2019.

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. This Annual Report contains statements about the company’s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ from those indicated as a result of various important factors, including those discussed in the company’s most recent annual report on Form 10-K and reports on Form 10-Q and Form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website or from Bristol-Myers Squibb Investor Relations. In addition, any forward-looking statements represent our estimates only as of the date hereof and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change. This Annual Report also contains certain non-GAAP financial measures, adjusted to include certain costs, expenses, gains and losses and other specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available on the company’s website at www.bms.com.

At Bristol-Myers Squibb, we are looking forward to an exciting future. We will build on the strong foundation of 2018 to grow our business and to help more patients. We have great medicines. We have great people.