Bristol-Myers Squibb (BMY) Tops Q3 EPS by 3c

Bristol-Myers Squibb (NYSE: BMY) reported Q3 EPS of $0.45, $0.03 better than the analyst estimate of $0.42. Revenue for the quarter came in at $3.92 billion versus the consensus estimate of $3.8 billion.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the third quarter included Eliquis, which grew by $175 million, Yervoy, which grew 47%, Sprycel, which grew 22%, Orencia, which grew 18%, and Daklinza and Sunvepra, which had combined sales of $49 million.

Opdivo

• In September, the company announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union (EU):
  • In the U.S., the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for previously treated advanced melanoma and set a Prescription Drug User Fee Act decision goal date of March 30, 2015. The FDA granted Opdivo Breakthrough Therapy designation for this indication. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.
  • In the EU, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Applications for nivolumab in non-small cell lung cancer (NSLC) – the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type – and in advanced melanoma. The application for advanced melanoma was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.
• Also in September, at the European Society for Medical Oncology Congress in Madrid, the company announced positive results from CheckMate -037, a Phase III randomized, controlled open-label study of Opdivo versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma who were previously treated with Yervoy. Based on a planned interim analysis of the co-primary endpoint, the objective response rate was 32% (95% CI = 24, 41) in the Opdivo arm (n=120) and 11% (95% CI = 4, 23) in the ICC reference arm (n=47) in patients with at least six months of follow up. The majority (95%) of responses were ongoing in the Opdivo arm and the median duration of response was not reached.

Eliquis

• In August, the company and its partner, Pfizer, announced that the FDA approved a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy.
• In July, the company and its partner, Pfizer, announced that the European Commission (EC) approved Eliquis for the treatment of DVT and PE, and the prevention of DVT and PE in adults. The approval applies to all EU member states as well as Iceland and Norway.
• In August, at the European Society of Cardiology Congress in Barcelona, Spain, the company and its partner, Pfizer, announced results of a pre-specified secondary analysis of the Eliquis Phase III AMPLIFY-EXT trial. The analysis evaluated clinical and demographic predictors of all-cause hospitalization in patients with VTE. Results from this analysis demonstrated that during the 12-month extended treatment of VTE, Eliquis significantly reduced the risk of hospitalization versus placebo. This effect was independent of other variables including renal function, the only other significant predictor of hospitalization in the AMPLIFY-EXT population.

Daklinza

• In August, the company announced that the EC approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. The approval allows for the marketing of Daklinza in all 28 EU member states.

Asunaprevir

• In October, the company announced that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has withdrawn its New Drug Application for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval for daclatasvir, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet needs.

Sustiva

• In October, the company announced that it has successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva (efavirenz) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) products, and that loss of patent exclusivity in the U.S. for efavirenz is not expected to occur until December 2017.

Bristol-Myers Squibb reaffirmed FY2014 non-GAAP EPS guidance.

For earnings history and earnings-related data on Bristol-Myers Squibb (BMY) click here.

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