07.16.21
Headquarters: New York, NY
twitter.com/bmsnews
www.bms.com
Year Established: 1887
Headcount: 30,000
Revenues: $42,518 (+63%)
Loss: $8,995 (n/m)
R&D: $11,143 (+81%)
TOP SELLING DRUGS
With the $74 billion acquisition of Celgene, Bristol-Myers Squibb catapulted into 2020’s #6 position. Completed in November 2019, financials for 2020 include a full year of Celgene operations, which contributed $15.7 billion of revenues or 60% of BMS’ 63% growth for the year. Eliquis, a leading oral anti-coagulant drug, also drove growth with sales up 16% to $9.2 billion. Additionally, the acquisition of MyoKardia for approximately $13.1 billion was completed in November 2020. Both acquisitions broaden BMS’ biopharmaceutical endeavors with several near-term assets in oncology, hematology, immunology and cardiovascular disease.
In 2020, BMS gained 13 approvals for new medicines and additional indications for marketed medicines in major markets (the U.S., EU and Japan), including regulatory milestones for Opdivo and Opdivo+Yervoy combinations, which BMS continues to explore along with other anti-cancer agents in numerous tumor types. In the field of hematology, BMS now has a leading presence through in-line assets Revlimid and Pomalyst.
Key regulatory approvals include Zeposia and Onureg, and liso-cel for the treatment of large B-cell lymphoma. Additionally, pipeline assets show promise in hematology malignancies through the company’s CELMoD agents, multiple modalities targeting B-Cell Maturation Antigen (BCMA), and next-gen cell therapies.
Corporate endeavors
With the acquisition of MyoKardia, BMS bolstered its cardiovascular franchise with mavacamten and a pipeline of promising candidates. Mavacamten, a potential first-in-class medicine for the treatment of obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease with high morbidity, brings significant commercial potential. Mavacamten in HCM was submitted for review by the FDA in March. BMS plans to explore mavacamten in additional indications, as well as develop MyoKardia’s two clinical-stage therapeutics danicamtiv and MYK-224.
In September, BMS also acquired Forbius, a clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. The acquisition provides full rights to Forbius's TGF-beta program, including the program's lead investigational asset, AVID200, which is in Phase I development.
Additionally, for $475 million in near-term upfronts, BMS obtained a global exclusive license to Dragonfly's interleukin-12 immunotherapy program, including its extended half-life cytokine DF6002. Dragonfly received FDA clearance in May 2020 for its investigational NDA to develop DF6002, which is currently in Phase 1/2 development in advanced solid tumors. BMS intends to advance the development of DF6002 in oncology and hematology.
BMS has also been focusing on expanding its manufacturing resources to support its growing cell therapy franchise. In March, construction began on a new, 244,000 sq.-ft., state-of-the-art cell therapy manufacturing facility in Devens, MA. This significant investment to support clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers, will enable quick ramp up of capacity for cell therapy products.
In addition, BMS recently selected Leiden, Netherlands to house a new cell therapy manufacturing site in Europe. Leiden will be the company’s fifth facility dedicated to cell therapy and its first in Europe, in addition to major contract manufacturing partnerships globally.
R&D advances
BMS’ core therapeutic areas encompass cancer, hematology, immunology, cardiovascular and fibrotic disease, with more than 50 unique compounds in clinical development.
Most recent approvals dating back to January include the use of Opdivo in combination with Cabometyx for the first-line treatment of advanced renal cell carcinoma, the most common kind of kidney cancer. In a trial, the drug combo reduced the risk of death by 40% vs. sunitinib, and the median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months vs. 8.3 months, respectively.
In addition, the drug combination demonstrated a superior objective response rate with twice as many patients responding compared to sunitinib (56% vs. 27%), and 8% vs. 5% achieved a complete response.
BMS picked up two more approvals in February 2021. The FDA approved Breyanzi, a new CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Also, the European Commission approved lnrebic for the treatment of disease-related splenomegaly or symptoms in adults with myelofibrosis, who are Janus Associated Kinase inhibitor naive or have been treated with ruxolitinib.
In March of 2020 BMS expanded it immunology franchise with the FDA approval of ZEPOSIA (ozanimod) for relapsing forms of multiple sclerosis (RMS). ZEPOSIA, a once daily oral medication, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients. In clinical trials, ZEPOSIA demonstrated efficacy on annualized relapse rate, a key clinical marker of disease activity, as compared to Biogen’s AVONEX. This also marked the first FDA-approval since the Celgene acquisition.
This past May, Zeposia was approved by the FDA for the treatment of moderately to severely active ulcerative colitis (UC), based on data from a Phase 3 trial that met its primary endpoint of clinical remission, as well as key secondary endpoints, including clinical response and endoscopic improvement.
Notably, BMS and bluebird bio, Inc. received approval from the FDA for Abecma as the first B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy for the treatment of relapsed or refractory multiple myeloma after four or more prior lines of therapy. Abecma is a personalized immune cell therapy approved as a one-time infusion. As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.
Alliances
In a recent agreement with The Rockefeller University, BMS gained a global exclusive license to develop, manufacture and commercialize Rockefeller’s novel monoclonal antibody (mAb) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. This treatment is a combination of two mAbs directed at blocking the SARS-CoV-2 spike protein and neutralizing the virus. Preclinical data suggest that this could enable effective treatment against multiple variants of the virus using a low dose subcutaneous administration, eliminating the need for intravenous infusion. Phase 1 clinical trials for the mAb duo were initiated in mid-January with plans to move rapidly to a registrational program following results.
An ongoing research collaboration with Syngene was extended through 2030 for drug discovery, including chemistry, biology, drug metabolism and pharmacokinetics, as well as translational medicine research and development. The extension will include a 40% increase in the number of scientists and the addition of a new 50,000 sq.-ft. dedicated lab space. Syngene's first dedicated R&D Center, the Biocon BMS R&D Center, was fully commissioned in 2009 and has become a major strategic R&D site for BMS.
BMS also extended its partnership with Evotec SE in the field of targeted protein degradation, with the goal to identify first-in-class drug candidates focusing on solid tumors. The partnership leverages Evotec's PanOmics platform and has generated a pipeline of first-in-class targeted protein degradation projects, two of which have transitioned into lead optimization.
Lastly, a strategic collaboration with Molecular Templates aims to discover and develop multiple therapies for specific oncology targets using MTEM’s next-gen engineered toxin body (ETB) platform. ETBs represent a new class of targeted therapeutics that act through differentiated mechanisms including the ability to force receptor internalization, deliver therapeutic payloads, and directly kill targeted cells through the enzymatic inactivation of ribosomes. BMS has selected the first target and has the option to obtain an exclusive worldwide license to ETBs directed to each selected target. MTEM will receive $70 million upfront and is eligible to receive milestones of up to $1.3 billion.
twitter.com/bmsnews
www.bms.com
Year Established: 1887
Headcount: 30,000
Revenues: $42,518 (+63%)
Loss: $8,995 (n/m)
R&D: $11,143 (+81%)
TOP SELLING DRUGS
| Drug | Indication | 2020 Sales | (+/-%) |
| Revlimid | Myelodysplastic syndrome (MDS) | $12,106 | >100% |
| Eliquis | deep vein thrombosis and pulmonary embolism | $9,168 | 16% |
| Opdivo | melanoma, lung cancer, renal cancer | $6,992 | -3% |
| Orencia | rheumatoid arthritis | $3,157 | 6% |
| Pomalyst | multiple myeloma | $3,070 | >100% |
| Sprycel | leukemia | $2,140 | 1% |
| Yervoy | oncology | $1,682 | 13% |
| Abraxane | lung, ovarian, and breast cancer | $1,247 | >100% |
| Empliciti | multiple myeloma | $381 | 7% |
| Reblozyl | anemia | $274 | n/a |
With the $74 billion acquisition of Celgene, Bristol-Myers Squibb catapulted into 2020’s #6 position. Completed in November 2019, financials for 2020 include a full year of Celgene operations, which contributed $15.7 billion of revenues or 60% of BMS’ 63% growth for the year. Eliquis, a leading oral anti-coagulant drug, also drove growth with sales up 16% to $9.2 billion. Additionally, the acquisition of MyoKardia for approximately $13.1 billion was completed in November 2020. Both acquisitions broaden BMS’ biopharmaceutical endeavors with several near-term assets in oncology, hematology, immunology and cardiovascular disease.
In 2020, BMS gained 13 approvals for new medicines and additional indications for marketed medicines in major markets (the U.S., EU and Japan), including regulatory milestones for Opdivo and Opdivo+Yervoy combinations, which BMS continues to explore along with other anti-cancer agents in numerous tumor types. In the field of hematology, BMS now has a leading presence through in-line assets Revlimid and Pomalyst.
Key regulatory approvals include Zeposia and Onureg, and liso-cel for the treatment of large B-cell lymphoma. Additionally, pipeline assets show promise in hematology malignancies through the company’s CELMoD agents, multiple modalities targeting B-Cell Maturation Antigen (BCMA), and next-gen cell therapies.
Corporate endeavors
With the acquisition of MyoKardia, BMS bolstered its cardiovascular franchise with mavacamten and a pipeline of promising candidates. Mavacamten, a potential first-in-class medicine for the treatment of obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease with high morbidity, brings significant commercial potential. Mavacamten in HCM was submitted for review by the FDA in March. BMS plans to explore mavacamten in additional indications, as well as develop MyoKardia’s two clinical-stage therapeutics danicamtiv and MYK-224.
In September, BMS also acquired Forbius, a clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. The acquisition provides full rights to Forbius's TGF-beta program, including the program's lead investigational asset, AVID200, which is in Phase I development.
Additionally, for $475 million in near-term upfronts, BMS obtained a global exclusive license to Dragonfly's interleukin-12 immunotherapy program, including its extended half-life cytokine DF6002. Dragonfly received FDA clearance in May 2020 for its investigational NDA to develop DF6002, which is currently in Phase 1/2 development in advanced solid tumors. BMS intends to advance the development of DF6002 in oncology and hematology.
BMS has also been focusing on expanding its manufacturing resources to support its growing cell therapy franchise. In March, construction began on a new, 244,000 sq.-ft., state-of-the-art cell therapy manufacturing facility in Devens, MA. This significant investment to support clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers, will enable quick ramp up of capacity for cell therapy products.
In addition, BMS recently selected Leiden, Netherlands to house a new cell therapy manufacturing site in Europe. Leiden will be the company’s fifth facility dedicated to cell therapy and its first in Europe, in addition to major contract manufacturing partnerships globally.
R&D advances
BMS’ core therapeutic areas encompass cancer, hematology, immunology, cardiovascular and fibrotic disease, with more than 50 unique compounds in clinical development.
Most recent approvals dating back to January include the use of Opdivo in combination with Cabometyx for the first-line treatment of advanced renal cell carcinoma, the most common kind of kidney cancer. In a trial, the drug combo reduced the risk of death by 40% vs. sunitinib, and the median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months vs. 8.3 months, respectively.
In addition, the drug combination demonstrated a superior objective response rate with twice as many patients responding compared to sunitinib (56% vs. 27%), and 8% vs. 5% achieved a complete response.
BMS picked up two more approvals in February 2021. The FDA approved Breyanzi, a new CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Also, the European Commission approved lnrebic for the treatment of disease-related splenomegaly or symptoms in adults with myelofibrosis, who are Janus Associated Kinase inhibitor naive or have been treated with ruxolitinib.
In March of 2020 BMS expanded it immunology franchise with the FDA approval of ZEPOSIA (ozanimod) for relapsing forms of multiple sclerosis (RMS). ZEPOSIA, a once daily oral medication, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients. In clinical trials, ZEPOSIA demonstrated efficacy on annualized relapse rate, a key clinical marker of disease activity, as compared to Biogen’s AVONEX. This also marked the first FDA-approval since the Celgene acquisition.
This past May, Zeposia was approved by the FDA for the treatment of moderately to severely active ulcerative colitis (UC), based on data from a Phase 3 trial that met its primary endpoint of clinical remission, as well as key secondary endpoints, including clinical response and endoscopic improvement.
Notably, BMS and bluebird bio, Inc. received approval from the FDA for Abecma as the first B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy for the treatment of relapsed or refractory multiple myeloma after four or more prior lines of therapy. Abecma is a personalized immune cell therapy approved as a one-time infusion. As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.
Alliances
In a recent agreement with The Rockefeller University, BMS gained a global exclusive license to develop, manufacture and commercialize Rockefeller’s novel monoclonal antibody (mAb) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. This treatment is a combination of two mAbs directed at blocking the SARS-CoV-2 spike protein and neutralizing the virus. Preclinical data suggest that this could enable effective treatment against multiple variants of the virus using a low dose subcutaneous administration, eliminating the need for intravenous infusion. Phase 1 clinical trials for the mAb duo were initiated in mid-January with plans to move rapidly to a registrational program following results.
An ongoing research collaboration with Syngene was extended through 2030 for drug discovery, including chemistry, biology, drug metabolism and pharmacokinetics, as well as translational medicine research and development. The extension will include a 40% increase in the number of scientists and the addition of a new 50,000 sq.-ft. dedicated lab space. Syngene's first dedicated R&D Center, the Biocon BMS R&D Center, was fully commissioned in 2009 and has become a major strategic R&D site for BMS.
BMS also extended its partnership with Evotec SE in the field of targeted protein degradation, with the goal to identify first-in-class drug candidates focusing on solid tumors. The partnership leverages Evotec's PanOmics platform and has generated a pipeline of first-in-class targeted protein degradation projects, two of which have transitioned into lead optimization.
Lastly, a strategic collaboration with Molecular Templates aims to discover and develop multiple therapies for specific oncology targets using MTEM’s next-gen engineered toxin body (ETB) platform. ETBs represent a new class of targeted therapeutics that act through differentiated mechanisms including the ability to force receptor internalization, deliver therapeutic payloads, and directly kill targeted cells through the enzymatic inactivation of ribosomes. BMS has selected the first target and has the option to obtain an exclusive worldwide license to ETBs directed to each selected target. MTEM will receive $70 million upfront and is eligible to receive milestones of up to $1.3 billion.
