Bristol-Myers: R&D Update Highlights Mid-Range Drugs Important to Offsetting Patent Losses

Bristol-Myers BMY hosted a research and development event on Sept.14 highlighting several mid-stage drugs that should enter pivotal studies over the next 18 months. While the heightened visibility increases our confidence in the firm’s moat, we didn’t see anything that materially changed our valuation outlook. We need to see the results of the pivotal studies to materially change our projections, as the early-stage data looks promising but still uncertain.

Bristol is largely maintaining its cancer focus with the next-generation drugs. Bristol is advancing CAR T-cell therapy BMS-986393 targeting GPRC5D in multiple myeloma, which holds solid efficacy and has been partly validated by the approval of J&J’s Talvey. Bristol’s treatment, however, would be one-time in nature, offering some benefits. Bristol is also advancing another multiple myeloma drug, alnuctamab, that targets BCMA and CD3. Bristol’s strong entrenchment in multiple myeloma should help increase the drugs’ probability of success. Additional advancing drugs target lymphoma, prostate cancer, lupus, and myelofibrosis. Exact timelines of approvals for these drugs remains unclear, but we would expect the majority to launch close to the 2028 patent losses for Bristol’s leading drugs Eliquis and Opdivo. The next-generation drugs will be critical to drive long-term growth for the firm.

Bristol also highlighted upcoming 2023 data for the subcutaneous, or sub-q, formulation of Opdivo as potentially extending exclusivity into the early 2030s. A sub-q version would save time and costs over the administration of the current intravenous administration but, given the lack of robust uptake of other sub-q cancer drugs like Herceptin, we are not currently building in much transition to sub-q Opdivo.

In the late-stage pipeline, pulmonary fibrosis drug BMS-986278, cardiovascular drug milvexian, and cancer drugs repotrectinib, iberdomide, and mezigdomide continue to track as expected and will likely be the next major launches.