TEVA launches first US generic Revlimid—but the generic volume is constrained by a prior patent settlement between CELG and Allergan (#msg-119362355):
The volume limit is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the United States during the first full year of entry. The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license[i.e. Apr 2026-Apr 2027] under this agreement.
This is why BMY’s guidance for 2022 Revlimid sales is still $9.5-10B (vs $12.8B in 2021: #msg-167758757), declining about $1.5B per year during 2023 and beyond.
2022 non-GAAP EPS was lowered by $0.21 due to an FASB accounting change regarding in-process R&D (i.e. accounting for acquisitions). The updated range for 2022 non-GAP EPS (unchanged other than the item described above) is $7.44-7.74.