Bristol Myers Squibb (BMY)

[DewDiligence]

BMY -1% on withdrawal of Opdivo/Yervoy BLA in 1L-NSCLC based on high-TMB data from CHECKMATE-227—despite solid 4Q18 results and 2019 financial guidance:

https://www.businesswire.com/news/home/20190124005154/en/Bristol-Myers-Squibb-Reports-Fourth-Quarter-Full-Year

After recent discussions with the FDA, the company believes further evidence on the relationship between TMB and PD-L1 is required to fully evaluate the impact of Opdivo plus Yervoy on OS in first-line NSCLC patients. This analysis will require availability of the final data from Checkmate -227, Part 1a (Opdivo plus low-dose Yervoy or Opdivo monotherapy versus chemotherapy in patients whose tumors express PD-L1), which the company anticipates will be available in the first-half of 2019. Since these data from Checkmate -227, Part 1a, will not be available within the review cycle of the current application the company decided to withdraw.

…Bristol-Myers Squibb is confirming its 2019 GAAP EPS guidance range of $3.75 - $3.85 and its non-GAAP EPS guidance range of $4.10 - $4.20. Both GAAP and non-GAAP guidance assume current exchange rates.

The above guidance excludes any effect from the planned acquisition of CELG.