Bristol-Myers Squibb's Q3 2025 Earnings Call: Contradictions Emerge on Cobenfy Adoption, ADEPT-2 Delays, Reimbursement Speed, Iberdomide's MRD Endpoint, and US Manufacturing/Tariff Strategy

Date of Call: October 30, 2025

Financials Results

• Revenue: $12.2B in Q3; growth portfolio +17% YOY; full‑year revenue guidance increased by $750M to $47.5B–$48.0B
• EPS: $1.63 diluted EPS in Q3; includes net charges of approximately $0.20 per share; full‑year non‑GAAP EPS guidance $6.40–$6.60 (midpoint unchanged)
• Gross Margin: 73% in Q3; full‑year gross margin guidance ~72% (unchanged)

Guidance:

• Increased 2025 revenue guidance by $750M to $47.5B–$48.0B and narrowed EPS to $6.40–$6.60 (midpoint unchanged).
• Full‑year gross margin guidance ~72%; operating expense guidance ~ $16.5B; OI&E expected ~ $500M; tax rate ~18%.
• Opdivo (with Qvantig) now expected to grow high single‑digit to low double‑digit for the year; growth portfolio up 17% YOY.
• Multiple pivotal readouts accelerating into 2026 including ADEPT programs, milvexian and iberdomide.

Business Commentary:

* Strong Growth Portfolio Performance: - The growth portfolio delivered a 17% year-over-year increase in sales, driven by multiple products like the IO portfolio, Reblozyl, Camzyos, and Breyanzi. - This growth was fueled by ongoing demand across these products and new indications, particularly in MSI-high colorectal cancer and first-line non-small cell lung cancer.

• Clinical and Regulatory Milestones:
• Bristol-Myers Squibb reported positive clinical data from the Phase III EXCALIBER study for Iberdomide, showing statistically significant improvement in MRD negativity rates.

• This milestone is expected to enhance the company's pipeline and address critical areas of unmet need, contributing to future growth.

• Business Development and Strategic Acquisitions:

• The company announced the acquisition of Orbital Therapeutics, enhancing its cell therapy franchise with a potential off-the-shelf asset, OTX-201.

• This acquisition is aimed at further strengthening Bristol-Myers Squibb's expertise in autoimmune diseases and cell therapy, providing an opportunity to define treatment paradigms in the autoimmunity space.

• Immunology and Cardiovascular Performance:

• Sotyktu sales grew 20% globally, and Eliquis global sales were $3.7 billion, up 23%.
• These increases were driven by continued demand for Sotyktu, strong Medicare Part D redesign impacts on Eliquis, and consistent demand across various indications.

Sentiment Analysis:

Overall Tone: Positive

• Management described Q3 as "another strong quarter": Q3 sales ~$12.2B, growth portfolio +17% YOY, diluted EPS $1.63, raised full‑year revenue guidance and maintained EPS midpoint, and highlighted accelerating pivotal readouts into 2026 as drivers of future growth.

Q&A:

• Question from Christopher Schott (JPMorgan Chase & Co, Research Division): Just I want to start with ADEPT-2. Is there any additional updates you can give us in terms of any actions, if any, that you've taken following some of the clinical site reviews you highlighted on the 2Q earnings? And then maybe just kind of putting the broader ADEPT program into context, as we think about ADEPT 1 and 4 next year, can you just talk about the relative confidence you have in those studies relative to ADEPT-2, just given some of the differences in study designs? Just maybe an update kind of broadly on how you're thinking about that indication.
  Response: Results expected by year‑end; company remains confident in the broader Cobenfy development program and notes ADEPT‑4 is a sister study while ADEPT‑1 uses a different relapse‑prevention design.

• Question from Geoffrey Meacham (Citigroup Inc., Research Division): Also on Cobenfy, but more commercial. How would you guys characterize the speed of reimbursement and maybe the depth of prescribers in the U.S.? I guess I'm just looking for what could be a tipping point of demand as it sounds like maybe there's more work to do on education. And then I also wanted to loop in Cristian here. I know obviously early days, but can you give us a sense of your priorities and maybe approach to development for a diversified portfolio like Bristol's?
  Response: Cobenfy has steady weekly TRx growth (~2,400 weekly TRx) with nearly 100% Medicare/Medicaid access and an expanded field force; CMO priorities are rigorous science‑based prioritization, flawless execution, delivering value, integrating AI/new tools and building talent.

• Question from Evan Seigerman (BMO Capital Markets Equity Research): I want to touch on the competitive landscape for the PD-L1/VEGF bispecific. So we saw some data at ESMO with PFS benefit in the HARMONi-6 trial in squamous non-small cell lung cancer. Can you just help frame how that maybe informs how you're thinking about your partnership with BioNTech? Does it make you more incrementally confident? Or is it really too early to read into kind of your program?
  Response: Partnership with BioNTech is strong; competitive and BioNTech data increase conviction in pumitamig and BMS is accelerating a broad development program to be first or second to market across indications.

• Question from David Amsellem (Piper Sandler & Co., Research Division): So I wanted to come back to Cobenfy and not trying to read too much into the prescription data over the summer relative to earlier this year. But I did want to ask about how you're thinking about potential or key barriers to adoption thus far? Is it GI tolerability? Is it twice daily dosing? Is it just prescriber inertia in terms of the dominance of the D2 blockers? Just wanted to get a better sense of what you're hearing and seeing in the field and what you think you need to do to drive more acceptance of the product among psychiatrists.
  Response: Primary barrier is physician inertia/switching from D2 blockers; company is addressing this via peer‑to‑peer education, real‑world data and a Phase IV switch study to build confidence and drive adoption.

• Question from Asad Haider (Goldman Sachs Group, Inc., Research Division): Congrats on the quarter. Just first for Chris or David, on the cost side, as it relates to your strategic productivity initiatives where another $1 billion in cost savings is expected to drop to the bottom line by 2027. Any updated thoughts on the shape of this over the next couple of years in the context of the potential R&D expenses associated with the development of BNT327 as it starts to move forward into later-stage Phase III programs, recognizing, of course, that you have other Phase III programs over the next 18 to 24 months that are going to come off. Just trying to understand the margin trajectory as we go through these pushes and pulls. And then second for Cristian, maybe just double-clicking on your previous response. Could you share with us any early thoughts on the pipeline and if there are programs that you're particularly encouraged by?
  Response: Company on track for $1B of savings in 2025 and $2B by 2027 while balancing investments and pipeline pushes/pulls; CMO highlighted milvexian, admilparant, protein degradation and cell‑therapy platforms as especially promising.

• Question from Mohit Bansal (Wells Fargo Securities, LLC, Research Division): My question is regarding the VEGF-PD-1 and the data we have seen from Summit so far. So what is your impression of the data, especially on the OS side of things? And the second part of the question is that -- I mean, there are 2 ways to think about it. One is like you could actually go after indications where PD-1s work really well or you could go after indications where VEGFs work well and PD-1 could add some value there. Is there an either/or approach here? Or could there be a scenario where it works better to improve the efficacy of VEGF with the VEGF PD-1 approach? How do you think about that?
  Response: Encouraged by magnitude/consistency of PFS data and believe it may translate to survival; strategy is twofold—compete in PD‑1‑sensitive settings and expand into VEGF‑sensitive indications (e.g., MSS CRC) while pursuing novel combinations.

• Question from Timothy Anderson (BofA Securities, Research Division): A couple of questions. The first is on trough earnings. Chris, are you still looking at very late 2020s relative to what you may have been forecasting, say, a year ago? Is that trending towards being pulled forward or being pushed back or maybe staying the same? There's been lots of developments both at Bristol and then industry-wide. And I'm wondering if any of that has changed the timing of reaching trough earnings. And then just on Cobenfy, as you undoubtedly know, there's heightened investor nervousness around ADEPT-2 on the back of comments that were made in Q2. Do you think investors read too much into those comments that Summit had made?
  Response: No change to formal long‑term/timing guidance; focus is on making the trough as shallow and short as possible—management cites strong commercial execution and late‑stage pipeline to navigate and exit the trough.

• Question from Luisa Hector (Joh. Berenberg, Gossler & Co. KG, Research Division): Maybe a policy question. I just wondered whether we should be worried about the lack of any subsequent deals with the administration. Is there perhaps a bandwidth issue? Just trying to -- you're in the queue waiting your turn to negotiate. And then maybe to sort of expand that a little bit on to potential DTC offerings. You already have Eliquis. Anything you can comment in terms of that going live, any impact on volumes? And then perhaps just a mention of that guidance that you have for Eliquis for '26 and '27. How confident are you? Can you tighten those ranges at all now that we're sort of through '25? You've seen the Part D restructure impact and the DTC. So some of those changes there, how they're informing your view of Eliquis as we go forward?
  Response: BMS is actively engaging on policy but sees nothing alarming; launched Eliquis direct‑to‑patient at >40% discount (strong inquiry) and will offer Sotyktu DTP at >80% discount; Part D redesign has smoothed sales timing and no tightening of Eliquis multi‑year guidance yet.

• Question from David Risinger (Leerink Partners LLC, Research Division): Congrats on the strong third quarter results. So I have 2 questions, please. First, milvexian is being dosed at 25 milligrams BID in secondary stroke prevention, which is the same daily dose as Bayer's asundexian 50 milligrams QD. So could you please discuss milvexian's profile, including its potency relative to asundexian? And comment on asundexian secondary stroke prevention Phase III trial readout in coming months and implications for milvexian's secondary stroke prevention readout in the second half of '26. And then my separate question is, are IRA prices for the first 10 price-controlled drugs in 2026, including Eliquis currently being renegotiated?
  Response: Milvexian's BID dosing chosen to ensure exposure and company is confident in its Phase III design; all three milvexian studies now expected to read out in 2026 (AF readout accelerated); Eliquis IRA negotiation not being revisited.

• Question from Carter Gould (Cantor Fitzgerald & Co., Research Division): I asked this question with an appreciation that your time lines have been consistent, but there's been lots of discussions around potential scenarios where you might add patients to sites that -- I'm talking about ADEPT-2, you might add patients to sites that under enrolled based. And can you address those discussions and say definitively, whether you've gone back and added more patients since enrollment was completed based on your own ct.gov entries? And could that address the variance between what was implied by those time lines and the actual time lines to data?
  Response: Management provided no operational specifics and reiterated that ADEPT‑2 results are expected by year‑end.

• Question from Terence Flynn (Morgan Stanley, Research Division): Maybe just another policy one. We've seen some headlines around these GLOBE and GUARD, what I assume are CMMI pilots for Medicare. Can you weigh in at all in terms of those, if there's any progress or any details in terms of how those might play out? And then a second question is just on iberdomide and your upcoming discussions with the FDA on a potential for a filing on MRD. What's your confidence level that FDA will actually move in that direction? Or do you think they're going to want to see more definitive data first before acting on MRD?
  Response: Too early to comment on CMMI pilots; for iberdomide, BMS will present positive MRD data to the FDA and other regulators to evaluate potential for accelerated/conditional approval.

• Question from Courtney Breen (Sanford C. Bernstein & Co., LLC., Research Division): Just one for me, particularly as we think about the PD-1 VEGF opportunity and the clinical development plan that you've alluded to here. What learnings are you taking from your first round in the PD-1 battle, the development and commercial kind of competition with Merck? What would you have done differently in that? And how are you using kind of a look back at that strategy to improve your approach in arguably a more complex and competitive environment?
  Response: Key learnings: order of entry matters; leverage decades‑long community‑oncology relationships and launch infrastructure; be agile to pivot to new indications and pursue novel, high‑value indications to maximize pumitamig's commercial potential.

• Question from Akash Tewari (Jefferies LLC, Research Division): Just on ADEPT-2, I think your team has hinted there are no site irregularities that you're seeing right now and dropouts seem to be similar to the schizophrenia studies. So if that's the case, why hasn't the data been locked at this point? And why open more ex U.S. sites? And can you also comment specifically on what you learned from the open-label period in your relapse prevention studies with Cobenfy and Alzheimer's psychosis?
  Response: Company reiterated ADEPT‑2 is close and will read out by year‑end and declined to provide operational details; ADEPT‑1 uses an open‑label 12‑week lead‑in for relapse‑prevention and those lead‑in data will be released when appropriate.

• Question from Steve Scala (TD Cowen, Research Division): I'm curious if you have concluded the IRA negotiations for Pomalyst and how did the results compare to expectations? GSK indicated yesterday that its negotiations concluded for one of its drugs, and they did not sound troubled in the least at the result of those negotiations. And I'll leave it to one question given the time is short.
  Response: IRA negotiations conclude tomorrow; Pomalyst will have lost U.S. exclusivity by MSP in Jan 2027 so negotiations should not materially affect outlook; negotiated price will be published by Nov 30.

Contradiction Point 1

Cobenfy Adoption by Physicians

It highlights differing perspectives on the primary hurdles and strategies for Cobenfy's adoption by physicians, which is crucial for the drug's commercial success.

What are the key barriers to adopting Cobenfy among psychiatrists, and what steps are needed to increase its adoption? - David Amsellem (Piper Sandler & Co., Research Division)

2025Q3: The main question from physicians is how to switch from D2 to Cobenfy. We're addressing this with peer-to-peer activities, real-world data, and a Phase IV switch study. - Adam Lenkowsky(CMO)

What are the main challenges to Cobenfy's adoption by physicians? - Christopher Thomas Schott (JPMorgan Chase & Co.)

2025Q2: Cobenfy is performing well, tracking over 2,000 TRxs per week. The main hurdle is changing entrenched prescribing behavior. We're increasing field force size, clarifying switching approaches, and expanding into hospitals. - Adam Lenkowsky(CMO)

Contradiction Point 2

ADEPT-2 Study Status

It involves differing statements about the status and timeline of the ADEPT-2 study, which is crucial for the clinical development and regulatory approval of Cobenfy.

Were patients added to ADEPT-2 sites due to low enrollment? Why hasn't the data been locked yet? - Carter Gould (Cantor Fitzgerald & Co., Research Division)

2025Q3: ADEPT-2 is on track for completion by the end of the year. - Christopher Boerner(CEO & Chairman)

Any update on the timing of trough earnings? Are investors overreading comments about ADEPT-2? - Timothy Anderson (BofA Securities, Research Division)

2025Q2: We expect to say a lot more about ADEPT-2 in the second half of the year, so we'll see. As I said, we're quite focused on making sure that we get this study done. - Christopher Boerner(CEO & Chairman)

Contradiction Point 3

Cobenfy Launch and Reimbursement Speed

It involves differing statements about the speed and success of Cobenfy's reimbursement, which impacts the drug's market penetration and financial performance.

How would you characterize the speed of reimbursement and prescriber depth for Cobenfy in the U.S.? What is your approach and priorities for developing Bristol's diversified portfolio? - Geoffrey Meacham (Citigroup Inc., Research Division)

2025Q3: Cobenfy's reimbursement speed is steady, with positive feedback from physicians. The focus is on increasing breadth and depth of prescribing, which will enhance growth. - Christopher Boerner(CEO)

How do you plan to scale Cobenfy’s adoption given entrenched physician prescribing habits and the current poor standard of care with significant unmet need in 2025? - Chris Schott (JPMorgan)

2024Q4: We are now at approximately 1,000 TRxs per week, with good progress achieving access goals. For Medicaid and Medicare, we've achieved over 90% Medicaid access and over 80% Medicare access. - Adam Lenkowsky(CMO)

Contradiction Point 4

Iberdomide and MRD Endpoint

It involves differing statements about the inclusion of MRD as a primary endpoint for Iberdomide, which affects the regulatory strategy and potential market access for the drug.

How do lessons from the PD-1/PD-L1 competition inform your PD-1/VEGF combination approach? - Courtney Breen (Sanford C. Bernstein & Co., LLC., Research Division)

2025Q3: Iber's positive MRD data is being discussed with FDA to explore accelerated conditional approval. - Cristian Massacesi(CMO)

Is the run rate for the new productivity initiative expected to reach $15 billion by year-end 2027? Has the FDA approved the addition of the MRD endpoint for Iberdomide? Can approval be obtained based solely on the MRD endpoint, or is follow-up PFS data required? - Terence Flynn (Morgan Stanley, Research Division)

2024Q4: For iberdomide, based on the discussions with the FDA, we've made the decision to include MRD as 1 of the primary endpoints in the clinical trial, and we'll certainly be reading that out most likely in this year. - Samit Hirawat(CMO)

Contradiction Point 5

US Manufacturing and Tariff Impact

It involves the company's strategy and exposure to tariffs, which can impact operational and financial aspects of the business.

Can you clarify the company's US manufacturing footprint, its ability to shift production to the US, and how it navigates tariff dynamics? - Christopher Schott (JPMorgan Chase & Co, Research Division)

2025Q3: We continue to have discussions with Administration, working to enhance the US manufacturing capability and capacity. - Christopher Boerner(CEO)

How do the ARISE trial results affect confidence in Alzheimer's psychosis trials, and what is the threshold for a meaningful reduction in hallucinations and delusions? - Luisa Hector (Berenberg)

2025Q1: We're actively engaged in discussions with the existing administration and the new administration and their focus on manufacturing and onshoring and our ability to shift manufacturing here. - David Elkins(CFO)