Bristol Myers Squibb Company 10-Q filed Oct 29, 2026

Modified · EXECUTIVE SUMMARY

In 2026, we made meaningful progress advancing have achieved multiple regulatory approvals across our pipelineportfolio, highlighted byincluding: (i) FDA acceptance approval of our NDA for first CELMoD, Zenbexus (iberdomide), in RRMMcombination with a PDUFA date daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of August 17, 2026adult patients with MM who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent in the U.S.; (ii) FDA acceptance approval of our NDA Camzyos for mezigdomide pediatric patients with symptomatic oHCM in RRMM with a PDUFA date the U.S.; (iii) approval of Sotyktu for the treatment of May 13, 2027adults with active PsA in the U.S. and EU; and (iiiiv) positive interim approval of Opdivo for cHL in the U.S. and EU. We have also made meaningful progress advancing our pipeline, highlighted by: (i) topline Phase IIIII results from the ROSETTA Lung-02 ALOFT-IPF study of pumitamigadmilparant in patientsadults with previously untreated advanced NSCLCIPF, which met its primary endpoint at the 60 mg dose; (ivii) positive topline interim results from two Phase III studies conducted in China for iza-bren results from the ACTION-1 study of RYZ101 in heavily pretreated, unresectable locally advanced or metastatic TNBC and recurrent or metastatic ESCCpatients with SSTR+ GEP-NETs who have progressed following Lu177-based therapy; and (viii) FDA acceptance of our sNDANDA for Camzyosmezigdomide in adolescentsRRMM with symptomatic oHCM with a PDUFA date of September 30May 13, 2026. Additionally, Sotyktu was approved in 2027; (iv) positive interim Phase II results from the U.S. and EU for ROSETTA Lung-02 study of pumitamig in patients with previously untreated advanced NSCLC; (v) positive topline Phase II results from the treatment registrational QUINTESSENTIAL study of adults arlo-cel in adult patients with active PsA quadruple-class exposed RRMM; and Opdivo was approved (vi) positive interim results from two Phase III studies conducted in the U.S. China for iza-bren in heavily pretreated, unresectable locally advanced or metastatic TNBC and EU for cHLrecurrent or metastatic ESCC.