Bristol-Myers Squibb Company‘s second quarter of 2018 results were boosted by strong sales for Eliquis (apixaban) and Opdivo (nivolumab), and significant regulatory progress in the company’s immuno-oncology portfolio.
|$ amounts in millions, except per share amounts|
|GAAP Diluted EPS||0.23||0.56||(59)%|
|Non-GAAP Diluted EPS||1.01||0.74||36%|
2Q Financial Results
- Second quarter 2018 revenues totaled $5.7 billion, an increase of 11 percent compared with the same period a year ago. Revenues increased 9 percent when adjusted for foreign exchange impact.
- U.S. revenues increased 13 percent to $3.2 billion in the quarter compared to the same period a year ago. International revenues increased 9 percent. When adjusted for foreign exchange impact, international revenues increased 4 percent.
- Gross margin as a percentage of revenue increased from 69.5 percent to 71.5 percent in the quarter primarily due to an impairment charge for a manufacturing site in the prior period.
- Marketing, selling, and administrative expenses decreased 5 percent to $1.1 billion in the quarter.
- Research and development expenses increased 45 percent to $2.4 billion in the quarter, which includes a $1.1 billion charge resulting from the Nektar collaboration in the second quarter of 2018.
- The effective tax rate was 26.1 percent in the quarter, compared to 28.8 percent in the second quarter last year. The effective tax rate includes a nondeductible equity investment loss in the second quarter of 2018.
- The company reported net earnings attributable to Bristol-Myers Squibb of $373 million, or $0.23 per share, in the second quarter compared to net earnings of $916 million, or $0.56 per share, for the same period in 2017.
- The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.6 billion, or $1.01 per share, in the second quarter, compared to $1.2 billion, or $0.74 per share, for the same period in 2017. An overview of specified items is provided under the “Use of Non-GAAP Financial Information” section.
- Cash, cash equivalents, and marketable securities were $8.2 billion, with a net cash position of $805 million, as of June 30, 2018.
2Q Products and Pipeline
Global revenues for the second quarter of 2018, compared to the second quarter of 2017, were driven by:
- Eliquis , which grew by $474 million or a 40 percent increase
- Opdivo , which grew by $432 million or a 36 percent increase
- Orencia , which grew by 9 percent
- Sprycel , which grew by 6 percent
- Yervoy , which decreased by 2 percent
- In July, the company announced the U.S. Food and Drug Administration (FDA) approved Opdivo plus low-dose Yervoy (injections for intravenous use) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
- In July, the company announced the EC has expanded the indication for Sprycel to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, and to include a powder for oral suspension formulation.
- In June, the company announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended expanded approval of the current indications for Opdivo to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The CHMP recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.
- In June, the company announced the FDA accepted its supplemental Biologics License Application for Opdivo plus low-dose Yervoy for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb).
- In June, the China National Drug Administration approved Opdivo for the treatment of locally advanced or metastatic NSCLC after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations.
- In May, the EMA validated a type II variation application for the Opdivo plus Yervoy combination for treatment in adult patients with first-line metastatic NSCLC who have TMB ≥10 mut/Mb.
2Q Business Development Update
In July, the company and Tsinghua University announced a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers. The collaboration brings together the respective scientific expertise and capabilities of both organizations with a focus on validating new targets and generating early drug candidates for clinical development.
The company and Nektar Therapeutics in April completed the agreement for the development and commercialization of NKTR-214 with Opdivo and Opdivo plus Yervoy, originally announced in February 2018. Also in April, the company and Flatiron Health announced a three-year agreement to curate regulatory-grade real-world data for cancer research and real-world evidence generation.
(Source: Bristol-Myers Squibb Company; Image credit: A4)
Filed Under: Drug Discovery