Bristol Myers Squibb (BMY) Q2 FY26 earnings call: guidance and Q&A

Can you provide more context on the delays for Milvexian and Cobenfy studies, specifically if there are changes in patient population or initial assumptions?

For Cobenfy ADEPT 1, the lower pace of psychotic relapses is a positive sign. For ADEPT 2 and 4, the focus on ensuring high quality in patient inclusion and study conduction impacted enrollment pace, but measures are now in place to accelerate. For Milvexian, the delay to Q1 2027 is due to a lower-than-predicted pace of event recruitment, but the DMC continues to endorse the study, which is seen favorably.

“ADEPT 1, we are recruiting events, psychotic relapses. And we are having now a lower pace of how we are recruiting these events than predicted. So this is -- can be seen overall as a positive way.”

asked by Geoff Meacham · answered by Cristian Massacesi

What hazard ratio is needed for Milvexian to be a very large opportunity versus an incremental product? Also, what specific assets are driving the upside in the growth portfolio guidance?

Milvexian is designed to demonstrate a superior bleeding profile compared to Eliquis with comparable efficacy, targeting the 40% of AF patients undertreated due to bleeding concerns. It's expected to shift first-line decision-making. The guidance increase is driven by pervasive strong growth across the growth portfolio, including Opdualag (+22%), Reblozyl (+29%), Breyanzi (+41%), Camzyos (+59%), and Qvantig (annualizing over $1 billion).

“Milvexian has the potential not just to unlock those patients but also, we expect milvexian to shift first-line decision-making over time, allowing physicians to initiate and maintain milvexian treatment more confidently than we can even do today by using Eliquis.”

asked by Chris Schott · answered by Adam Lenkowsky

What specific technologies or therapeutic areas are most exciting for Bristol-Myers Squibb's business development strategy?

The company is excited by new, innovative targets and modalities. This includes leveraging better understanding of disease biology in areas like cancer, neuroscience, and cardiovascular. Examples include protein degradation platforms (like CELMoDs) and advancements in neuroscience, such as Alzheimer's portfolio development focusing on targets like amyloid and tau, and improving brain penetration for drugs.

“I'm excited by what is new, what is innovative in terms of new targets, but also the way you deliver your drugs against that target, the modalities.”

asked by Evan Seigerman · answered by Cristian Massacesi

Can you provide an update on educational efforts for Cobenfy titration in schizophrenia and its impact on sales? Also, what is the confidence in Sotyktu's MOA for lupus given upcoming readouts?

Cobenfy is showing steady growth with positive trends in total script volumes (+15% QoQ) and increasing new prescribers. Education on titrating to the 125mg dose is ongoing, and an increase in 125mg prescribing is observed. Sotyktu is a strategically important asset for lupus, with confidence stemming from positive Phase II results that met primary and key secondary endpoints. The Phase III studies mimic the Phase II design, and Sotyktu has potential to differentiate on efficacy, steroid reduction, and safety.

“In fact, in the quarter, we saw roughly a 15% growth in TRxs quarter-over-quarter.”

asked by Emily Field · answered by Adam Lenkowsky

How does Admilparant fit into the IPF landscape if its clinical benefit is in line with current drugs, and what is the use case? What is the timing for the PPF trial readout and positioning strategy?

Admilparant, an LPA1 antagonist, is novel as it works on fibrotic, inflammatory, and potentially remodeling pathways. Phase II results were positive, and Phase III tests two doses (60mg and 120mg), with the 120mg dose showing reassuring safety in blinded data. IPF readout is expected this year, and PPF a few months after. The market has significant unmet needs in efficacy and tolerability (GI issues with current agents). The IPF/PPF market, currently $4 billion, could double to $8-$10 billion by mid-2030s with improved treatments. Admilparant has the potential to be foundational as a first branded option and used in combination.

“Today, this is a roughly $4 billion market. We expect this market to grow significantly with improved treatment that could maybe double to $8 billion to $10 billion by the middle of the 2030s with improved treatment options.”

asked by Asad Haider · answered by Adam Lenkowsky

How do you see Iberdomide and Mezigdomide contributing to the company's revenue growth in 2028-2030, particularly in existing indications?

CELMoDs, including Iberdomide and Mezigdomide, represent a significant commercial opportunity and are expected to drive strong growth. Iberdomide's PDUFA is August 17, and Mezigdomide's is May 13, 2027. They are positioned to replace Pomalyst and Revlimid in leading triplet regimens in second-line myeloma, aiming to become foundational treatments. Strong adoption is expected, with PFS data for Iberdomide accelerating uptake. Arlo-cel, a third CELMoD, also has potential in first-line follicular lymphoma.

“Our goal is to make iber and mezi foundational myeloma, replacing rev and [indiscernible] in second line over time.”

asked by Seamus Fernandez · answered by Adam Lenkowsky

Can you discuss the efficacy and safety of Admilparant's 120mg dose, particularly regarding blood pressure? Also, clarify if Milvexian's noninferiority study allows for a hazard ratio upper bound above 1.0.

For Admilparant, the 120mg dose was introduced based on modeling showing a dose-relation, and DMC monitoring has shown reassuring safety, including for blood pressure, in a blinded way. The studies are fully powered for both doses. For Milvexian, the noninferiority margins are around 1.0, and the study is powered to show noninferiority, meaning it's expected to be as good as Eliquis on strokes and systemic embolism, and better on bleeding.

“What I can tell you is that DMC is monitoring regulated study. We completed the recruitment and we are waiting the readout, and there was in a blinded way, very reassuring events, safety profile rate.”

asked by Michael Yee · answered by Cristian Massacesi

How should the DMC's continued endorsement of the Milvexian study be interpreted as a positive signal for efficacy, given that lower bleeding risk is already known?

The DMC routinely reviews both safety and efficacy. Their continued endorsement, especially with slowing event rates, indicates that efficacy is in line with expectations to continue the study. This increases confidence that Milvexian can read out competitively against Eliquis. The fact that the DMC has not stopped the study, unlike other trials where detriment on the primary endpoint led to cessation, is a positive signal for efficacy.

“So having DMC continues to assess the efficacy and safety data, as you say, and giving us very much closer to the final readout, the reassurance that the study can progress as planned is a good thing.”

asked by David Risinger · answered by Cristian Massacesi