Bristol Myers Squibb’s highly anticipated Cobenfy just finished its first trip around the sun as an approved drug, posting results in line with expectations that leave investors wondering when an inflection point might arrive.
Approved by the FDA to treat schizophrenia in September 2024 and officially launched the following month, Cobenfy generated third-quarter sales of $43 million, compared with $35 million in the second quarter. The quarterly number largely met Wall Street’s expectations of $44 million, according to Citi.
Cobenfy’s performance looks relatively underwhelming compared to the company’s overall 3% revenue beat, driven by above-consensus sales from several other new medicines, such as anemia drug Reblozyl and CAR-T therapy Breyanzi.
During BMS’s earnings call Thursday, CEO Chris Boerner, Ph.D., described Cobenfy as “delivering steady growth.” But the first-in-class drug still has a long way to go to fulfill its promise as a potential multibillion-dollar product.
“We’re establishing a new treatment paradigm in what we knew was going to be a highly entrenched market,” Adam Lenkowsky, chief commercialization officer of BMS, said on the call.
Cobenfy is entering a disease field where dopamine D2 receptor antagonists have been the mainstay of treatment for three decades. The new med’s progress is tracking ahead of all recently launched analogs in schizophrenia, Lenkowsky said, as the drug has surpassed 2,400 weekly total scripts.
“There’s clearly more work to do,” the BMS exec acknowledged. “In year two, we need to continue to increase both breadth and depth of prescribing […] We’ve onboarded our expanded field force now in the community and in the hospital setting.”
BMS is working hard to get more doctors to try out Cobenfy. To help build physician confidence, the company is resorting to peer education for new prescribers, introducing real-world data and running a phase 4 study to address the key question of how to switch from a D2 drug to Cobenfy.
“Based on the leading indicators that we’re seeing, Cobenfy is going to deliver continued, steady growth in schizophrenia, and longer-term growth is going to be fueled by additional indications,” Lenkowsky said, adding that “we are confident that Cobenfy will be a big drug over time.”
But as one analyst pointed out on Thursday’s call, investors have grown nervous around a key potential Cobenfy expansion opportunity in Alzheimer’s disease psychosis following some recent management comments.
During the company’s second-quarter earnings call in July, BMS’ then-chief medical officer Samit Hirawat, M.D., mentioned that as part of a bigger project to improve success for all BMS clinical programs, the New Jersey pharma was conducting clinical trial site reviews of the Adept-2 trial, which is slated to read out this year as the first of three Cobenfy phase 3 studies in Alzheimer’s disease psychosis. BMS has said it’ll need positive readouts from two of the three trials to be able to file with the FDA.
“I wouldn’t read too much into it, other than to say that there’s a lot of focus on us being able to deliver on each of the stages of our strategy,” Boerner said Thursday.
“If I step back from the specific studies, remember the work that we’re doing in development fits with the focus that we have on execution, really across the company,” the CEO added. “And given the importance of the late-stage studies, I think it’s prudent that we take whatever learnings we can and pull whatever appropriate levers we can to ensure that we deliver these studies with the highest [probability of technical success] and on time.”
Hirawat was recently succeeded by Cristian Massacesi, M.D., who came over from AstraZeneca. On Thursday’s call, Massacesi said that the Cobenfy development program is “progressing really at a rapid pace.” The new CMO counted 14 studies that are either ongoing or in the process of being activated, including 10 pivotal studies.
Zooming out of specific products, Boerner highlighted a “very dynamic” policy environment inside and outside the U.S. Three Big Pharma companies—Pfizer, AZ and Merck KGaA’s EMD Serono—have signed “most favored nation” drug pricing deals with the Trump administration.
Pfizer’s deal was announced Sept. 30, and since EMD Serono struck the third pact Oct. 16, no new agreement with the U.S. government has emerged.
“We continue to actively engage with the administration,” Boerner said. “I would characterize those discussions as frequent and, while not always fully aligned, they’re always constructive and thought-provoking on both sides.”
“We agree with the President on the need for equalization of prices,” he continued. “U.S. prices need to come down. We’re sharing ideas to do that. Ex-U.S. prices need to come up. We’ve seen some good progress—for example, in the U.K.—but more needs to be done. And accomplishing those objectives while preserving the ecosystem for innovation that we have in the U.S. is what we’re focused on.”