Bristol-Myers Squibb reported a turnaround to profit in the fourth quarter, while the year-ago period's reflected the impact from the U.S. tax reform.
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Looking ahead, the company affirmed its earnings outlook for fiscal 2019.
But in a setback for the company, Bristol-Myers also said that after discussions with the U.S. FDA, it is voluntarily withdrawing the U.S. supplemental Biologics License Application or sBLA for the Opdivo and low-dose Yervoy (ipilimumab) combination for treatment of first-line advanced non-small cell lung cancer or NSCLC.
The company believes further evidence on the relationship between tumor mutational burden or TMB and PD-L1 is required.
Fourth-quarter net income attributable to the company was $1.19 billion or $0.73 per share, compared to net loss of $2.33 billion or $1.42 per share for the year-ago period.
The year-ago period's results include the significant transitional impact from U.S. tax reform.
Adjusted net earnings for the quarter were $0.94 per share, compared to $0.68 per share in the previous year. On average, analysts polled by Thomson Reuters expected the company to report earnings of $0.85 per share for the quarter. Analysts' estimates typically exclude special items.
Total revenues for the quarter grew 10 percent to $5.97 billion from $5.45 billion in the same period a year ago. Revenues increased 12 percent when adjusted for the impact of foreign exchange. Wall Street expected revenues of $5.99 billion for the quarter.
U.S. revenues increased 16 percent to $3.3 billion in the quarter compared to the same period a year ago. International revenues increased 3 percent. When adjusted for foreign exchange impact, international revenues rose 7 percent.
In early January, Bristol-Myers said it agreed to acquire Celgene Corp. (CELG) in a cash and stock transaction with an equity value of about $74 billion.
For fiscal 2019, the company affirmed its outlook for reported earnings per share of $3.75 to $3.85 and adjusted earnings in a range of $4.10 to $4.20 per share. The company projects worldwide revenues to increase in the mid-single digits. ■