Mavacamten

After four failed phase 3 trials, Bristol Myers Squibb CEO Chris Boerner said a new chief medical officer represents "an opportunity for a refresh." Bristol Myers Squibb had a strong quarter, with key drugs old and new coming in either above or in line with Wall Street’s expectations.The New Jersey pharma’s $12.3 billion revenues in the second quarter handily beat analysts’ consensus by 7.7%. As a result, the company raised its full-year revenue outlook by $700 million at the midpoint, to a new range between $46.5 billion and $47.5 billion.Both legacy products, such as blood cancer drug Revlimid and Pfizer-partnered blood thinner Eliquis, and newer drugs, including heart disease med Camzyos and cell therapy Breyanzi, outperformed expectations during the period. Most notably, despite a 38% year-over-year decline, Revlimid’s $838 million haul during the quarter landed a surprising 40% above consensus.But investors’ attention remains focused on the schizophrenia drug Cobenfy, despite its small $35 million contribution to BMS’ top line in the second quarter.The number slightly beat analysts’ projection of $32 million, as BMS continues to see prescription growth. Still, the sales are far from the multibillion-dollar territory that BMS and industry watchers believe the novel antipsychotic could reach. Cobenfy is now tracking over 2,000 total weekly scripts in the U.S., BMS Chief Commercialization Officer Adam Lenkowsky told investors on a call Thursday.“As we previously communicated, we knew it was going to take time to change what’s been decades of entrenched prescribing behavior; and indeed, I think that’s been the case,” Lenkowsky said.BMS is expanding its community field force to increase reach and frequency because “it takes multiple calls to change physician behavior,” he said. Addressing a common question from doctors about how to switch from traditional meds, BMS is introducing peer-to-peer assistance and running a phase 4 switch study, which is expected to read out this year.Lenkowsky described a phased approach to Cobenfy’s expansion: first in the community setting, then to hospitals and, ultimately, new indications.However, Cobenfy recently failed as an adjunctive treatment in patients with inadequately controlled schizophrenia. BMS, having observed a numerical improvement and a positive sign through a post-hoc subgroup analysis of the Arise trial, has said it would talk with the FDA about a potential path forward.That discussion has not yet happened, and BMS continues to analyze the data, BMS’ chief medical officer, Samit Hirawat, M.D., said on Thursday’s call.Meanwhile, investors are shifting their focus to Cobenfy’s opportunity in Alzheimer’s disease psychosis, with Adept-2, the first of three phase 3 trials, on track to report data this year. BMS needs at least two positive studies to be able to file for an approval there.Cobenfy is a combination of xanomeline and trospium chloride. Xanomeline has shown some benefits for treating psychosis symptoms in Alzheimer’s, but as one analyst noted on Thursday’s call, xanomeline on its own demonstrated a clear problem with patient dropouts in an earlier trial. Hirawat argued that people should not draw direct conclusions from that case, because BMS’ trials mark “a huge difference” from the xanomeline study conducted 30 years ago.Counting Cobenfy’s Arise trial flop, all four of BMS’ pivotal data readouts so far this year have been negative. The other three setbacks were Opdualag in adjuvant melanoma, Camzyos in non-obstructive hypertrophic cardiomyopathy and, more recently, Reblozyl in myelofibrosis-associated anemia. Clinical failures of those growth products don’t look very promising for a company that’s bracing itself for a major loss-of-exclusivity phase. But BMS CEO Chris Boerner appeared less concerned.“First, as we look back at the studies that haven’t gone the way we had anticipated, there are two things I think are important to keep in mind,” Boerner said on the investor call. “The first is that when you look at those studies in totality, while they were meant to answer important scientific questions or clinical practice questions, they collectively have relatively limited impact on the long-term growth of the company.”“What is more important is whether or not those studies have any implications going forward,” the chief executive continued. “And we don’t see any read-forward from those studies to future opportunities.”That said, BMS is bringing on a new chief medical officer as of Aug. 1: Cristian Massacesi, M.D., formerly AstraZeneca’s chief medical officer and oncology chief development officer.“In many respects, not just with respect to the early pipeline, but really across drug development, there’s going to be a focus that we have on execution,” Boerner said of Massacesi’s appointment.While Hirawat has laid the foundation for some R&D initiatives at BMS, “anytime you bring somebody in from outside the company, you would expect that they would bring a different approach, a different level of energy, a different way of thinking,” Boerner continued. “So, I think there’s an opportunity for a refresh there as well.”