BMY Bristol-Myers Squibb Company

59.14
+0.16  (+0%)
Previous Close 58.98
Open 59.3
52 Week Low 42.48
52 Week High 68.34
Market Cap $133,815,472,111
Shares 2,262,689,755
Float 2,261,072,260
Enterprise Value $163,679,652,139
Volume 11,366,050
Av. Daily Volume 16,216,303
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Upcoming Catalysts

Drug Stage Catalyst Date
ide-cel bb2121 - KarMMa
Relapsed/refractory multiple myeloma
BLA Filing
BLA Filing
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CC-486-AML-001
AML Maintenance
PDUFA priority review
PDUFA priority review
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liso-cel (JCAR017) - TRANSCEND NHL-001
Relapsed or refractory (R/R) large B-cell lymphoma
PDUFA priority review
PDUFA priority review
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CM-274 Opdivo (nivolumab)
Bladder cancer
Phase 3
Phase 3
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Nivolumab Plus Ipilimumab (CM 816)
Non-Small Cell Lung Cancer (NSCLC)
Phase 3
Phase 3
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CM-648 Opdivo + Yervoy
Esophageal Cancer
Phase 3
Phase 3
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Opdivo (nivolumab) and Ipilimumab (Yervoy) CM-915
Melanoma
Phase 3
Phase 3
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REVLIMID - MAGNIFY NHL-008
Relapsed or Refractory Indolent Lymphoma
Phase 3
Phase 3
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ABRAXANE - PANC-003 apact
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
Phase 3
Phase 3
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Relatlimab and Nivolumab
Melanoma
Phase 2/3
Phase 2/3
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NKTR-214 + OPDIVO (nivolumab) - PIVOT-2
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
Phase 1/2
Phase 1/2
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CM-651 – Opdivo + Yervoy
First-line Head and Neck Cancer
Phase 3
Phase 3
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CM-649 – Opdivo+ Yervoy or Chemo
Gastric cancer
Phase 3
Phase 3
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IPI-549 + Nivolumab (MARIO-275)
Urothelial cancer
Phase 2
Phase 2
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CM-577 - Opdivo
Esophageal cancer
Phase 3
Phase 3
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CM-901 Opdivo + Yervoy
Urothelial Cancer
Phase 3
Phase 3
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CM-548 - Opdivo
First-line Glioblastoma (GBM) cancer
Phase 3
Phase 3
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Opdivo and Rubraca ATHENA
Ovarian Cancer - First-line maintenance treatment
Phase 3
Phase 3
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Ozanimod
Crohn's disease
Phase 3
Phase 3
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CM-914 Opdivo in combination with Yervoy
Renal Cell Carcinoma
Phase 3
Phase 3
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Cabozantinib and Nivolumab and Ipilimumab (COSMIC-313)
Renal Cell Carcinoma
Phase 3
Phase 3
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Luspatercept - COMMANDS
First-line, lower-risk Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Cabozantinib /nivolumab and ipilimumab (CM-040)
Hepatocellular cancer
Phase 1b
Phase 1b
Phase 1b ORR 19% (cabozantinib and nivolumab) /29% (cabozantinib, nivolumab and ipilimumab) - January 24, 2020.
Enasidenib (AG-221) - IDHENTIFY
Refractory Acute myeloid leukemia (AML) - cancer
Phase 3
Phase 3
Global Phase 3 study for AG-221 initiated October 2015. Continues to enroll as of January 2018.
Ozanimod - TRUE NORTH
Ulcerative Colitis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - June 2, 2020.
ADCETRIS and Opdivo CM-744
Relapsed/Refractory Classical Hodgkin Lymphoma
Phase 2
Phase 2
Phase 2 presentation at EHA June 15, 2019.
CM-9LA Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA Approval announced May 26, 2020.
POMALYST (pomalidomide)
Kaposi’s sarcoma
Approved
Approved
FDA Approval announced May 15, 2020.
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA Approval announced May 15, 2020.
Luspatercept - INDEPENDENCE
Myelofibrosis
Phase 3
Phase 3
Phase 3 trial to commence by end of 2020.
CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER
First-line renal cell carcinoma
Phase 3
Phase 3
Phase 3 trial met PFS and OS endpoints - April 20, 2020.
CM-602 – Opdivo + pomalidomide and dexamethasone
Multiple Myeloma
Phase 3
Phase 3
Phase 3 clinical hold lifted June 1, 2018.
JCARH125 - EVOLVE
Multiple myeloma
Phase 1
Phase 1
Phase 1 data at ASH 2018 noted at lowest dose ORR 79%; CR 43%.
CM-743 Opdivo + Yervoy
Mesothelioma
Phase 3
Phase 3
Phase 3 met overall survival endpoint at interim analysis - April 20, 2020.
Luspatercept
Myelodysplastic syndromes (MDS) cancer
Approved
Approved
FDA Approval announced April 3, 2020.
ZEPOSIA (Ozanimod)
Relapsing Multiple Sclerosis
Approved
Approved
FDA Approval announced March 26, 2020.
Liso-cel (JCAR017) - TRANSCEND CLL-004
Chronic Lymphocytic Leukemia (CLL)
Phase 1
Phase 1
Phase 1 updated data at ASH December 8, 2019. 45.5% CR; 81.5% ORR.
Opdivo and Yervoy
Previously Treated Hepatocellular Carcinoma
Approved
Approved
FDA Approval announced March 11, 2020.
Lenalidomide and Dexamethasone and Elotuzumab (ELOQUENT - 1)
Multiple Myeloma
Phase 3
Phase 3
Phase 3 trial did not meet progression-free survival primary endpoint - March 9, 2020.
JCAR017 in combination with durvalumab - PLATFORM
Non-hodgkin Lymphoma
Phase 1b
Phase 1b
Phase 1b initiated.
TG4010 and Opdivo
Non-squamous non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 data due 2018.
bb21217
Multiple Myeloma
Phase 1
Phase 1
Phase 1 data at ASH December 9, 2019 - 83% complete response.
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
Approved
Approved
FDA Approval announced March 8, 2019.
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
Approved
Approved
Approval announced August 1, 2017.
Fedratinib
Myelofibrosis
Approved
Approved
FDA Approval announced August 16, 2019.
Luspatercept
Beta-thalassemia
Approved
Approved
FDA Approval announced November 8, 2019.
ABRAXANE - NSCL-003 abound.sqm
First-line late stage Squamous Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 data released June 2017 - met the endpoint of a pre-planned interim futility analysis.
REVLIMID
Multiple myeloma (MM) - autologous stem cell transplant (ASCT)
Approved
Approved
Approved February 22, 2017.
Ozanimod - SUNBEAM
Relapsing Multiple Sclerosis
Phase 3
Phase 3
Phase 3 data due released Feb 17, 2017 - primary endpoint met, disability endpoint not met. Full data released October 27, 2017 at ECTRIMS meeting.
liso-cel (JCAR017) - TRANSCEND OUTREACH
Relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL)
Phase 2
Phase 2
Phase 2 trial initiated 4Q 2018.
REVLIMID - MM-026 ARUMM
Multiple Myeloma - Maintenance Post-VMP induction
Phase 3
Phase 3
Phase 3 enrollment complete - noted April 27, 2017.
REVLIMID - AUGMENT
Relapsed or Refractory Follicular Lymphoma
Approved
Approved
FDA Approval announced May 28, 2019.
CM-459 – Opdivo
First-line Hepatocellular carcinoma (HCC) - cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - June 24, 2019.
Epacadostat with Opdivo (nivolumab) - (ECHO-207)
Solid tumors
Phase 1/2
Phase 1/2
Phase 1/2 initiated April 2017.
CM-331– Opdivo
Second-line Small cell lung cancer (SCLC)
Phase 3
Phase 3
Phase 3 data released October 12, 2018 - primary endpoint not met.
CM-451 – Opdivo + Yervoy
First-line Small cell lung cancer (SCLC)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - November 26, 2018.
CM-511 – Opdivo + Yervoy
First-line Melanoma
Phase 3
Phase 3
Phase 3 ongoing.
CM-568 - Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 presentation at AACR Meeting April 16, 2018.
BMS-986205 and Nivolumab
Advanced tumors
Phase 1/2
Phase 1/2
Late-breaker at SITC November 11, 2017. ORR 14-32%.
CM-714 Opdivo + Yervoy
First-line Head and Neck Cancer
Phase 2
Phase 2
Phase 2 data April 25, 2019 did not meet primary endpoints.
CM-498 Opdivo
Phase 3 data due 2H 2019.
Phase 3
Phase 3
Phase 3 data released May 9, 2019 did not meet primary endpoint.
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Approved
Approved
FDA Approval announced January 2, 2019.
Empliciti (elotuzumab) - ELOQUENT-3
Relapsed/refractory multiple myeloma
Approved
Approved
FDA approval announced November 6, 2018.
Opdivo and Rubraca
Triple-negative breast cancers
Phase 3
Phase 3
Phase 3 trial planned.
CM-32 - Opdivo+chemo
Small cell lung cancer (SCLC)
Approved
Approved
FDA approval announced August 17, 2018.
CM-142 – Opdivo
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
Approved
Approved
Approval announced July 11, 2018.
Opdivo (nivolumab)
Bladder cancer
Approved
Approved
Urothelial Carcinoma - Bladder cancer
CM-214 – Opdivo + Yervoy
First-line Renal cell carcinoma (RCC)
Approved
Approved
Approved April 16, 2018.
Opdivo - 4 week applications
Approved
Approved
Approval announced March 6, 2018.
CM-238 – Opdivo (Adjuvant)
Melanoma
Approved
Approved
Phase 3 interim data released June 6, 2017 - primary endpoint met. Data presented at ESMO September 10, 2017 - HR 0.65 compared to Yervoy. FDA Approval announced December 20, 2017.
CM-143 – Opdivo
Second-line Glioblastoma (GBM) cancer
Phase 3
Phase 3
Phase 3 data released April 3, 2017 - primary endpoint not met.
CM-078 – Opdivo
Second-line Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 30, 2017.
Opdivo - ONO-4538-12
Gastric cancer
Phase 3
Phase 3
Phase 3 data released January 19, 2017.
CM - 067 Opdivo in combination with Yervoy
Melanoma
Phase 3
Phase 3
Phase 3 first overall survival (OS) positive data released April 3, 2017
CM-142 – Opdivo
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
Approved
Approved
Approval announced August 1, 2017.
ORENCIA
Psoriatic Arthritis (PsA)
Approved
Approved
Approval announced July 6, 2017.
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia
Approved
Approved
Approval announced November 10, 2017.

Latest News

  1. Reblozyl regulates late-stage red blood cell (RBC) maturation to potentially reduce or eliminate the need for regular RBC transfusions

    Reblozyl is the first and only erythroid maturation agent to be approved in the European Union, representing a new class of therapy

    Bristol Myers Squibb (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) today announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:

    • Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.
    • Adult patients with transfusion-dependent anemia associated…

    Reblozyl regulates late-stage red blood cell (RBC) maturation to potentially reduce or eliminate the need for regular RBC transfusions

    Reblozyl is the first and only erythroid maturation agent to be approved in the European Union, representing a new class of therapy

    Bristol Myers Squibb (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) today announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:

    • Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.
    • Adult patients with transfusion-dependent anemia associated with beta thalassemia.

    "Dependence on blood transfusions caused by anemia in hematologic malignancies like MDS can often mean frequent and lengthy hospital visits, which can pose additional health risks and affect patients' quality of life," said Uwe Platzbecker, M.D., lead investigator of the MEDALIST study, Head of Clinic and Policlinic for Hematology and Cell Therapy, Leipzig University Hospital. "Today's approval of Reblozyl provides healthcare professionals with a new therapy that has been shown to significantly reduce the number of red blood cell transfusions needed by MDS patients and, in some cases, helped them to achieve transfusion independence."

    "While beta thalassemia remains an orphan disease, the lifelong blood transfusions often needed by patients can have a significant impact on the limited blood supply in their communities, and there are few treatment alternatives," said Maria Domenica Cappellini, M.D., lead investigator of the BELIEVE study, Professor of Medicine, University of Milan, Fondazione IRCCS Ca Granda. "The European Commission's approval of Reblozyl provides eligible adult patients with beta thalassemia a new, much needed treatment option for their anemia, and with it, the possibility of becoming less dependent on red blood cell transfusions."

    Reblozyl is the first and only erythroid maturation agent approved in the European Union, representing a new class of therapy for eligible patients. This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.

    "Across the EU, 25 million blood transfusions occur every year, some of which are needed by patients with anemia due to hematologic diseases like MDS and beta thalassemia," said Diane McDowell, M.D., vice president, Hematology Global Medical Affairs, Bristol Myers Squibb. "Reblozyl has the potential to address the ineffective erythropoiesis associated with MDS and beta thalassemia, decrease patients' dependence on red blood cell transfusions and impact the underlying consequences of the high burden of anemia for these patients. Alongside our partners at Acceleron, we recognize the continuing need in disease-related anemias and are committed to working collaboratively with European health authorities to make Reblozyl available to these patients as quickly as possible."

    About MEDALIST

    MEDALIST is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of Reblozyl plus best supportive care (BSC) versus placebo plus BSC in adults with IPSS-R-defined very low-, low- or intermediate-risk non-del(5q) MDS. All patients were RBC transfusion-dependent and were either refractory or intolerant to prior erythropoiesis stimulating agent (ESA) therapy, or were ESA naïve and unlikely to respond due to endogenous serum erythropoietin levels of ≥ 200 U/L, and had no prior treatment with disease modifying agents.

    The trial showed a statistically significant improvement in RBC transfusion burden with Reblozyl, the study's primary endpoint, with 37.9% of patients treated with Reblozyl achieving independence from RBC transfusions for at least eight weeks during the first 24 weeks of the trial compared to 13.2% of patients on placebo. The trial also met the secondary endpoint of transfusion independence for at least 12 weeks within the first 24 and 48 weeks of the study, which was achieved in a significantly greater proportion of patients receiving Reblozyl versus placebo.

    The majority of treatment-emergent adverse events (TEAEs) were Grade 1-2. Grade 3 or 4 TEAEs were reported in 42.5% of patients who received Reblozyl and 44.7% of patients who received placebo. Discontinuation due to an adverse reaction (Grades 1-4) occurred in 4.5% of patients who received Reblozyl. The most common (>10%) all-grade adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis and urinary tract infection.

    Results of the MEDALIST trial were first presented during the Plenary Session of the American Society of Hematology (ASH) Annual Meeting in December 2018 (ASH Abstract #001) and were selected for the Best of ASH. The New England Journal of Medicine published the MEDALIST trial results in January 2020.

    About MDS

    MDS are a group of hematologic malignancies characterized by ineffective production of healthy red blood cells, white blood cells and platelets, which can lead to anemia and frequent or severe infections, and can progress to Acute Myeloid Leukemia (AML). People with MDS who develop anemia often require regular blood transfusions to increase the number of healthy red blood cells in circulation. Frequent transfusions are associated with an increased risk of transfusion reactions, infections and iron overload. There are approximately 50,000 patients with MDS in the EU5 countries (France, Germany, Italy, Spain and the United Kingdom).

    About BELIEVE

    BELIEVE is a Phase 3, randomized, double-blind, placebo-controlled multi-center study comparing Reblozyl plus BSC versus placebo plus BSC in adults who require regular RBC transfusions (6-20 RBC units per 24 weeks with no transfusion-free period greater than 35 days during that period) due to beta thalassemia.

    The trial showed a statistically significant improvement in RBC transfusion burden during weeks 13 to 24 compared to the baseline 12-week interval prior to randomization (21.4% Reblozyl versus 4.5% placebo), meeting the study's primary endpoint. The trial also met the secondary endpoint of transfusion burden reduction of at least 33% (with a reduction of at least two units) during weeks 37 to 48, which was achieved in a significantly greater proportion of patients receiving Reblozyl versus placebo. The trial also met an exploratory endpoint, with 70.5% of patients treated with Reblozyl achieving at least a 33% reduction in RBC transfusion burden of at least two units for any 12 consecutive weeks compared to the 12-week interval prior to treatment, compared to 29.5% of patients on placebo.

    The majority of TEAEs were Grade 1-2. Discontinuation due to an adverse reaction (Grades 1-4) occurred in 5.4% of patients who received Reblozyl. The most common adverse reactions (>10%) were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea and dizziness.

    Results of the BELIEVE trial were first presented at the ASH Annual Meeting in December 2018 and selected for the Best of ASH. The New England Journal of Medicine published the BELIEVE trial results in March 2020.

    About Beta Thalassemia

    Beta thalassemia is an inherited blood disorder caused by a genetic defect in hemoglobin. The disease is associated with ineffective erythropoiesis, which results in the production of fewer and less healthy RBCs, often leading to severe anemia—a condition that can be debilitating and can lead to other complications for patients—as well as other serious health issues. Treatment options for anemia associated with beta thalassemia are limited, consisting mainly of frequent RBC transfusions that have the potential to contribute to iron overload, which can cause serious complications such as organ damage. Across the United States, Germany, France, Italy, Spain and the United Kingdom, there are approximately 17,000 patients with beta thalassemia.

    About Reblozyl®

    Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, promotes late-stage red blood cell maturation in animal models. Bristol Myers Squibb and Acceleron are jointly developing Reblozyl as part of a global collaboration. Reblozyl is currently approved in the U.S. for the treatment of:

    • anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, and
    • anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

    Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

    U.S. Important Safety Information

    WARNINGS AND PRECAUTIONS

    Thrombosis/Thromboembolism

    In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

    Hypertension

    Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

    Embryo-Fetal Toxicity

    REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

    ADVERSE REACTIONS

    Beta Thalassemia

    • Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
    • Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%)

    Myelodysplastic Syndromes

    • Grade >3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients
    • The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection

    LACTATION

    It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

    Please see full Prescribing Information and Summary of Product Characteristics for REBLOZYL

    Bristol Myers Squibb: Advancing Cancer Research

    At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients' quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

    Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

    About Bristol Myers Squibb

    Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

    Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

    About Acceleron

    Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

    Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States for the treatment of anemia in certain blood disorders. The Companies are also developing luspatercept for the treatment of chronic anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial.

    For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

    Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the outcome of pricing and reimbursement negotiations in individual countries in Europe may delay or limit the commercial potential of Reblozyl for the indications described in this release, and whether such product candidate for such additional indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

    Acceleron Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Acceleron's strategy, future plans and prospects, including statements regarding the development and commercialization of Acceleron's compounds, the timeline for clinical development and regulatory approval of Acceleron's compounds, the expected timing for reporting of data from ongoing clinical trials, and the potential of Reblozyl® (luspatercept-aamt) as a therapeutic drug. The words "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "may," "plan," "potential," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that the results of any clinical trials may not be predictive of the results or success of other clinical trials, that regulatory approval of Acceleron's compounds in one indication or country may not be predictive of approval in another indication or country, that the development of Acceleron's compounds will take longer and/or cost more than planned, that Acceleron or its collaboration partner, Bristol-Myers Squibb Company will be unable to successfully complete the clinical development of Acceleron's compounds, that Acceleron or Bristol Myers Squibb may be delayed in initiating, enrolling or completing any clinical trials, and that Acceleron's compounds will not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in Acceleron's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other filings that Acceleron has made and may make with the SEC in the future.

    The forward-looking statements contained in this press release are based on management's current views, plans, estimates, assumptions, and projections with respect to future events, and Acceleron does not undertake and specifically disclaims any obligation to update any forward-looking statements.

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  2. BOCA RATON, Fla., June 18, 2020 /PRNewswire/ -- Vidence, LLC, an oncology informatics company, was officially launched today as an independent entity to provide the world's leading cancer researchers, innovators and providers with the most comprehensive clinical and genomic data and insights. Founded by leading members of the medical and technical communities, Vidence fills an evidence gap in oncology and helps pharmaceutical and biotech firms and other healthcare institutions accelerate the development of cancer treatments and optimize patient care. 

    "With Vidence and our proprietary technology platform, SCIMON, we aim to satisfy an immediate need within the cancer field to provide valuable insight and analysis and take oncology information to the next level," said Percy Van Crocker, Jr., MBA, President and Co-Founder of Vidence. "From patients themselves to hospitals and clinics to pharmaceutical and biotech firms, we are excited to collaborate with all members of the medical community to help improve the treatment journey for cancer patients."

    Vidence's SCIMON brings together data and analytics in one patient-centric knowledge repository producing rich datasets and a longitudinal (multi-angle) view of each patient's journey. Specifically, SCIMON includes information and insights on more than 100,000 patients from electronic health records (EHRs), genomic testing results, patient surveys, claims and other key data points that capture:  Time (diagnosis to survival), Depth of Moments (clinical-genomic-outcomes), and Breadth of Story (e.g., social determinants) – a unique three-dimensional approach.

    One of Vidence's impactful ongoing collaborations is with Bristol Myers Squibb (NYSE:BMY) and uses clinical and genomic data from the SCIMON platform to estimate overall and progression-free survival in a retrospective real-world study in multiple tumor types. Based on clinical and demographic characteristics, along with patient-reported outcomes generated through the SCIMON platform, Vidence analysts can determine predictive factors of long-term disease remission and survival in multiple tumor types and provide evidence-based insights to Bristol Myers Squibb.  

    "As a long-term believer in the value of data-driven insights in the care and treatment of patients with cancer, Bristol Myers Squibb is excited to partner with Vidence and its Consortium Fellows on a new retrospective real-world study to analyze treatment patterns and outcomes in patients with multiple common tumor types and biomarker testing results," said Kate Larkin, Senior Vice President, U.S. Value, Access & Payment and Health Economics & Outcomes Research, Bristol Myers Squibb. "Vidence's SCIMON platform will enable us to derive clinically meaningful insights from the right combination and depth of cancer data to inform our oncology research and drug development program."  

    Vidence partners with a network of hospital systems, independent hospitals and clinics as Consortium Fellows.  Each Consortium Fellow contributes critical oncology data and benefits from the knowledge and insights provided through the services of the SCIMON platform. Consortium Fellows also benefit from SCIMON's ability to access, organize, analyze and visualize their own data as well as insights from the collective data, all in a rich and structured environment.

    As part of the SCIMON platform, the valuable insights generated from analysis of these complete data sets can be made available to cancer researchers and innovators, including pharmaceutical companies, biotech firms, and other healthcare institutions. These partners, in turn, work to accelerate innovation, improve care and patient outcomes, facilitate drug development and inform health economics.

    About Vidence, LLC

    Vidence harnesses the power of clinical and genomic data and insights to advance the treatment and outcomes for oncology patients. An oncology informatics company, Vidence provides the world's leading cancer researchers, innovators and treatment providers with access and contribution to the most comprehensive knowledge base of patient journeys and outcomes. Vidence was established as an independent company in order to expand the impact of data-driven analytics and data stewardship in oncology to a broader network of hospital systems, independent hospitals and clinics. It will be led by its three founders:  Percy Van Crocker, Jr., Robert Hauser, PharmD, PhD, and Rachel Schweers, PhD, JD.  The founders of the renowned Cancer Treatment Centers of America (CTCA) created Vidence to set a standard in the industry for high-quality data. As Vidence partners with a network of hospital systems, independent hospitals and clinics as Consortium Fellows, CTCA is one of these partners. Visit vidence.com for more information.

    Media Contacts:

    Rachel Schweers

     

    C: (773) 614-0670

    Dean Mastrojohn



    C: (347) 585-5620

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/vidence-llc-launched-to-set-standard-for-high-quality-cancer-data-research-and-analytics-301079769.html

    SOURCE Vidence, LLC

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  3. Bristol Myers Squibb Company (NYSE:BMY) will announce results for the second quarter of 2020 on Thursday, August 6, 2020. During a conference call at 8:30 a.m. ET on August 6, 2020, company executives will review financial results and will address inquiries from investors and analysts.

    Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com or by dialing in the U.S. toll free 800-458-4121 or international 786-789-4772, confirmation code: 8970168. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12:00 p.m. ET on August 6 through 12:00 p.m. ET on August 20, 2020. The replay will also be…

    Bristol Myers Squibb Company (NYSE:BMY) will announce results for the second quarter of 2020 on Thursday, August 6, 2020. During a conference call at 8:30 a.m. ET on August 6, 2020, company executives will review financial results and will address inquiries from investors and analysts.

    Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com or by dialing in the U.S. toll free 800-458-4121 or international 786-789-4772, confirmation code: 8970168. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12:00 p.m. ET on August 6 through 12:00 p.m. ET on August 20, 2020. The replay will also be available through http://investor.bms.com or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 8970168.

    About Bristol Myers Squibb

    Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

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  4. Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol Myers Squibb") announced today the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $19,000,000,000 aggregate principal amount of senior unsecured notes previously issued on May 16, 2019 ("May Notes") pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), and (ii) $18,545,623,000 aggregate principal amount of its outstanding senior unsecured notes previously issued on November 22, 2019 (the "November Notes" and, together with the May Notes, the "Original Notes") pursuant to an exemption from the registration requirements of the Securities Act, for an equal principal…

    Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol Myers Squibb") announced today the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $19,000,000,000 aggregate principal amount of senior unsecured notes previously issued on May 16, 2019 ("May Notes") pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), and (ii) $18,545,623,000 aggregate principal amount of its outstanding senior unsecured notes previously issued on November 22, 2019 (the "November Notes" and, together with the May Notes, the "Original Notes") pursuant to an exemption from the registration requirements of the Securities Act, for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes").

    The May Notes were issued in a private offering to fund a portion of the aggregate cash consideration payable in connection with the Bristol Myers Squibb's acquisition of Celgene Corporation ("Celgene") and to pay related fees and expenses. The November Notes were issued in a private offering upon the completion of Bristol Myers Squibb's offers to exchange ("prior exchange offers") any and all outstanding notes issued by Celgene.

    Bristol Myers Squibb is offering to issue the Registered Notes to satisfy its obligations under the registration rights agreement entered into with the initial purchasers of the May Notes and the registration rights agreement entered into with the dealer managers for the prior exchange offers. The Registered Exchange Offers do not represent a new financing transaction.

    The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the issuance of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. Bristol Myers Squibb will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes.

    The following table sets forth the outstanding aggregate principal amount of each series of Original Notes. The Registered Exchange Offers consist of offers to exchange up to the entire aggregate principal amount of each series of Original Notes for an equal principal amount of the corresponding series of Registered Notes.

    Title of Series of Notes

    Amount

    Outstanding

    2.875% Senior Notes due 2020

    $1,243,777,000

    3.950% Senior Notes due 2020

    $436,313,000

    Senior Floating Rate Notes due 2020

    $750,000,000

    2.875% Senior Notes due 2021

    $434,815,000

    2.250% Senior Notes due 2021

    $464,576,000

    2.550% Senior Notes due 2021

    $1,000,000,000

    3.250% Senior Notes due 2022

    $861,709,000

    3.550% Senior Notes due 2022

    $891,870,000

    Senior Floating Rate Notes due 2022

    $500,000,000

    2.600% Senior Notes due 2022

    $1,500,000,000

    2.750% Senior Notes due 2023

    $697,660,000

    3.250% Senior Notes due 2023

    $932,101,000

    4.000% Senior Notes due 2023

    $636,086,000

    3.625% Senior Notes due 2024

    $882,510,000

    2.900% Senior Notes due 2024

    $3,250,000,000

    3.875% Senior Notes due 2025

    $2,379,532,000

    3.200% Senior Notes due 2026

    $2,250,000,000

    3.450% Senior Notes due 2027

    $961,528,000

    3.900% Senior Notes due 2028

    $1,456,162,000

    3.400% Senior Notes due 2029

    $4,000,000,000

    4.125% Senior Notes due 2039

    $2,000,000,000

    5.700% Senior Notes due 2040

    $245,785,000

    5.250% Senior Notes due 2043

    $391,925,000

    4.625% Senior Notes due 2044

    $976,477,000

    5.000% Senior Notes due 2045

    $1,959,524,000

    4.350% Senior Notes due 2047

    $1,236,433,000

    4.550% Senior Notes due 2048

    $1,456,840,000

    4.250% Senior Notes due 2049

    $3,750,000,000

    Total

    $37,545,623,000

    Bristol Myers Squibb will accept for exchange any and all Original Notes validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on July 15, 2020 (as the same may be extended by Bristol Myers Squibb with respect to one or more series of Original Notes, the "Expiration Date"). Prior to the Expiration Date, tenders of Original Notes may be withdrawn according to the procedures described in the Prospectus (as defined below). Promptly after the Expiration Date, Bristol Myers Squibb will settle the Registered Exchange Offers by issuing Registered Notes pursuant to the terms of the Registered Exchange Offers.

    A Registration Statement on Form S-4 (File No. 333-238533) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on May 20, 2020 and was declared effective on June 15, 2020. The Registered Exchange Offers are being made pursuant to the terms and subject to the conditions set forth in a prospectus dated June 16, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement. The complete terms and conditions of the Registered Exchange Offers, including instructions regarding procedures for tendering Original Notes, are described in the Prospectus, the Registration Statement and related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent in connection with the Registered Exchange Offers, at (866) 924-2200 (U.S. toll-free) or (212) 430-3774.

    This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein. The Registered Exchange Offers are being made solely pursuant to the terms and conditions of the Prospectus, the Registration Statement, the related letter of transmittal and the other related materials.

    About Bristol Myers Squibb

    Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as "should," "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements are likely to relate to, among other things, our ability to execute successfully our strategic plans, including our business development strategy generally and in relation to our ability to realize the projected benefits of our acquisition of Celgene, the full extent of the impact of the novel coronavirus disease 2019 (COVID-19) pandemic on our operations and the development and commercialization of our products, the expiration of patents or data protection on certain products, including assumptions about our ability to retain patent exclusivity of certain products and the impact, and the result of governmental investigations. No forward-looking statement can be guaranteed.

    Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to, risks relating to: integrating Bristol Myers Squibb's and Celgene's business and operations, including with respect to human capital management, portfolio rationalization, finance and accounting systems, sales operations and product distribution, pricing systems and methodologies, data security systems, compliance programs and internal controls processes; our ability to realize the anticipated benefits from the Celgene acquisition; the impact of our significant additional indebtedness that we incurred and our issuance of additional shares in connection with the Celgene acquisition on our ability to operate the combined company; various risks related to public health outbreaks, epidemics and pandemics, including the impact of the COVID-19 pandemic on our operations, the possibility of the COVID-19 pandemic delaying the timing of the FDA's approval decisions and that we cannot reasonably assess or predict at this time the full extent of the adverse effect that the COVID-19 pandemic will have on our business, financial condition, results of operations and cash flows; challenges inherent in new product development, including obtaining and maintaining regulatory approval; increasing pricing pressures from market access, pharmaceutical pricing controls and discounting and other restrictions in the United States, the European Union and other regions around the world (including changes in rules and practices of managed care organizations and institutional and governmental purchasers); the possibility of difficulties and delays in product introduction and commercialization; our ability to obtain and protect market exclusivity rights and enforce patents and other intellectual property rights; the risk of certain novel approaches to disease treatment (such as CAR T therapy); industry competition from other manufacturers; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions; the impact of any U.S. healthcare reform and legislation or regulatory action in the U.S. and markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or access; changes in tax law and regulations; any decline in our future royalty streams; the failure of our suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; our ability to execute our financial, strategic and operational plans; our ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; our ability to attract and retain key personnel; our ability to effectively manage acquisitions, divestitures, alliances and other portfolio actions and to successfully realize the expected benefits of such actions; our dependency on several key products; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products, including, without limitation, interruptions caused by damage to our and our suppliers' manufacturing sites; regulatory decisions impacting labeling, manufacturing processes and/or other matters; the impact on our competitive position from counterfeit or unregistered versions of our products or stolen products; the adverse impact of cyber-attacks on our information systems or products, including unauthorized disclosure of trade secrets or other confidential data stored in our information systems and networks; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; and issuance of new or revised accounting standards.

    The foregoing list sets forth some, but not all, of the factors that could have an impact upon our ability to achieve results described in any forward-looking statements. All of the forward-looking statements that we make in this press release are qualified by (i) the information contained under this heading and (ii) the information discussed under the sections entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by the risk factors discussed in our Quarterly Reports on Form 10-Q and future filings with the Securities and Exchange Commission.

    Persons reading this press release are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements are and will be based upon management's then-current views and assumptions regarding future events and operating performance and are applicable only as of the dates of such statements. You also should understand that it is not possible to predict or identify all such factors and that this list should not be considered a complete statement of all potential risks and uncertainties. Investors also should realize that if underlying assumptions prove inaccurate or if unknown risks or uncertainties materialize, actual results could vary materially from our projections. Except as otherwise required by law, we are not under any obligation, and expressly disclaims any obligation, to update, alter, or otherwise revise any forward-looking statements included in this press release, whether written or oral, that may be made from time to time relating to any of the matters discussed in this press release, whether as a result of new information, future events or otherwise, as of any future date.

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  5. JERUSALEM, June 12, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2019 and provided a business update.

    Fourth Quarter 2019 Financial Summary

    Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.456 (NIS/$US) as at December 31, 2019.

    • Total operating expenses were NIS 32.5 million (approximately $9.4 million) compared with NIS 27.9 million for the fourth quarter of 2018.
    • R&D expenses for the fourth quarter amounted to NIS 31.6 million ($9.1 million) compared with NIS 26.6 million for the fourth quarter of 2018.

    Full Year 2019 Financial Summary

    • Total operating expenses for 2019 were NIS 78.3 million ($22.6 million) compared with NIS 77 million in 2018.
    • R&D expenses for 2019 amounted to NIS 68.6 million ($19.8 million) compared with NIS 71.9 million in 2018.

    As of December 31, 2019, BiondVax had cash and cash equivalents of NIS 72.4 million ($20.9 million) compared to NIS 75.8 million as of December 31, 2018. Complete financial results are available in the Company's annual report on Form 20-F for the year ended December 31, 2019, which is being filed with the Securities and Exchange Commission today.

    *Tables to follow*

    2019 Highlights and Recent Corporate Update

    • Pivotal clinical efficacy Phase 3 trial: The pivotal Phase 3 clinical trial aims to compare the safety and clinical efficacy of M-001 versus a placebo in preventing flu illness (as primary endpoints), and in reducing flu illness severity (as a secondary endpoint) from circulating influenza strains. Prior to both the 2018/19 and 2019/20 flu seasons, a total of over 12,400 adult volunteers aged 50+ (with half aged 65+) in seven European countries were enrolled. To date, no serious treatment related adverse events have been identified. Monitoring of the trial's second cohort (enrolled for the 2019/20 flu season) is nearly complete, and the Phase 3 clinical trial results are expected by the end of 2020.
    • NIH-supported Phase 2 clinical trial: The clinical study report (CSR) of the NIH-supported Phase 2 clinical trial was completed earlier this week. The CSR concludes that "M-001 was safe in this study" and that "M-001 induced significant polyfunctional T cell responses," indicating that both primary endpoints of the trial were achieved. The trial in 120 adult volunteers, supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was conducted by several of NIAID's Vaccine Treatment and Evaluation Units (VTEUs) in the U.S.
    • Pilot manufacturing facility: Equipment installation and scale-up in BiondVax's pilot manufacturing facility in Jerusalem are in progress. The facility has planned annual capacity of up to between 10 and 20 million doses in bulk.
    • €24 million non-dilutive co-funding: The European Investment Bank (EIB) extended the 2017 co-financing agreement from €20 million to €24 million to support construction of BiondVax's pilot manufacturing facility in Israel and Phase 3 trial. BiondVax was honored to host Mr. Ambroise Fayolle, EIB Vice-President, during his visit to BiondVax in June 2019 for a signature event celebrating the extension of the financing agreement.  
    • $20 million rights offering: In June and July 2019, BiondVax raised approximately US$20 million in a rights offering to existing shareholders.
    • Warrant expiration: BiondVax received proceeds of approximately $4.2 million through exercises of BiondVax warrants between January 1, 2020 and expiration of the warrants in May 2020.
    • New Board members: In September 2019, Mr. Mark Germain was appointed Chairman of the Board of Directors. In March 2020, Mr. Samuel Moed, Dr. Yael Margolin, and Mr. Adi Raviv were elected to the board. Mr. Moed recently served as Senior Vice President, Corporate Strategy at Bristol Myers Squibb (NYSE:BMY).

    About BiondVax

    BiondVax (NASDAQ:BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

    Contact Details

    Joshua E. Phillipson | +972 8 930 2529 |  

     



    BALANCE SHEETS

    In thousands, except share and per share data

















    Convenience















    Translation







    December 31,



    December 31,







    2018



    2019



    2019







    N I S



    U.S. dollars

    CURRENT ASSETS:















    Cash and cash equivalents





    75,883



    72,467



    20,968

    Other receivables





    965



    656



    190























    76,848



    73,123



    21,158

    LONG–TERM ASSETS:















    Property, plant and equipment





    28,249



    34,981



    10,122

    Right-of-use assets





    -



    7,136



    2,065

    Other long-term assets





    740



    510



    148























    28,989



    42,627



    12,335























    105,837



    115,750



    33,493

    CURRENT LIABILITIES:















    Trade payables





    20,723



    17,062



    4,937

    Current maturities of lease liabilities





    -



    694



    201

    Other payables





    1,076



    1,203



    348























    21,799



    18,959



    5,486

    LONG–TERM LIABILITIES:















    Liability in respect of government grants





    14,643



    14,812



    4,286

    Lease Liabilities





    -



    6,809



    1,970

    Loan from others





    94,360



    123,780



    35,816

    Warrants





    6,168



    16,354



    4,732

    Severance pay liability, net





    82



    89



    26























    115,253



    161,844



    46,830

    SHAREHOLDERS' EQUITY:















    Ordinary shares of NIS 0.0000001 par value: Authorized:

    391,000,000 shares at December 31, 2019 and 2018;

    Issued and outstanding: 402,351,657 and 261,419,599,

    shares at of December 31, 2019 and 2018, respectively





    *)   -



    *)   -



    *)   -

    Share premium





    179,929



    255,285



    73,867

    Accumulated deficit





    (211,144)



    (320,338)



    (92,690)























    (31,215)



    (65,053)



    (18,823)























    105,837



    115,750



    33,493

    *)            Represents amounts less than NIS\USD 1.



     

     

     

    STATEMENTS OF COMPREHENSIVE LOSS

    In thousands, except share and per share data













    Convenience translation







    Year ended

    December 31,



    Year ended

    December 31,







    2017



    2018



    2019



    2019







    N I S



    U.S. dollars

    Operating expenses:



















    Research and development, net of participations





    18,777



    71,913



    68,645



    19,863

    Marketing, general and administrative





    4,879



    5,154



    9,706



    2,808





















    Total operating expenses





    23,656



    77,067



    78,351



    22,671





















    Operating loss





    (23,656)



    (77,067)



    (78,351)



    (22,671)

    Financial income





    18



    2,936



    4



    1

    Financial expense





    (10,913)



    (13,596)



    (30,847)



    (8,926)





















    Loss  





    (34,551)



    (87,727)



    (109,194)



    (31,596)





















    Other comprehensive loss:







































    Items to be reclassified to profit or loss in subsequent periods:



















    Loss from available-for-sale marketable

    securities





    (6)



    -



    -



    -





















    Total comprehensive loss





    (34,557)



    (87,727)



    (109,194)



    (31,596)





















    Basic and diluted loss per share





    (0.17)



    (0.34)



    (0.33)



    (0.09)





















    Weighted average number of shares outstanding used to compute basic and diluted loss per share





    201,030,768



    261,419,599



    326,651,721



    326,651,721

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/biondvax-announces-fourth-quarter-and-full-year-2019-financial-results-and-provides-business-update-301075059.html

    SOURCE BiondVax Pharmaceuticals Ltd.

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