Bristol-Myers beats by $0.01, beats on revs; guides FY18 EPS in-line; Pivotal Phase 3 CheckMate -227 study demonstrates superior progression-free survival (pfs) with the Opdivo Plus Yervoy Combination versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients with high tumor mutation burden (TMB) (63.48)
- Reports Q4 (Dec) earnings of $0.68 per share, excluding non-recurring items, $0.01 better than the Capital IQ Consensus of $0.67; revenues rose 3.9% year/year to $5.45 bln vs the $5.35 bln Capital IQ Consensus. revenues increased 7% to $2.9 billion in the quarter compared to the same period a year ago. International revenues increased 1%. When adjusted for foreign exchange impact, international revenues decreased 3%. Gross margin as a percentage of revenue decreased from 73.6% to 69.3% in the quarter primarily due to product mix.
- Opdivo +4% to $1.36 bln vs. $1.3 bln estiamtes; Eliquis +44% to $1.36 bln.
- Co issues in-line guidance for FY18, sees EPS of $3.15-3.30, excluding non-recurring items, vs. $3.23 Capital IQ Consensus Estimate. Worldwide revenues increasing in the low- to mid-single digits. Gross margin as a percentage of revenue to be ~70% for both GAAP and non-GAAP. Marketing, selling and administrative expenses decreasing in the low- to mid-single digit range for both GAAP and non-GAAP.
- The ongoing Phase 3 CheckMate -227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high (=10 mutations/megabase, mut/mb) tumor mutation burden (TMB), regardless of PD-L1 expression. In the study, TMB was evaluated using Foundation Medicine's (Nasdaq: FMI) analytically validated assay FoundationOne CDx. Additionally, based on an interim analysis for overall survival (OS), the Data Monitoring Committee recommended that the study continue. The safety profile was consistent with previously reported findings in first-line NSCLC for the combination schedule of Opdivo 3 mg/kg every two weeks and low-dose Yervoy (1 mg/kg) every six weeks. "TMB has emerged as an important biomarker for the activity of immunotherapy. For the first time, this Phase 3 study shows superior PFS with first-line combination immunotherapy in a predefined population of NSCLC patients with high TMB."