Category: BMY

Bristol-Myers Squibb Company (NYSE:BMY) Bank of America Securities 2023 Health Care Conference May 9, 2023 11:40 AM ET

Company Participants

Adam Lenkowsky – EVP, Head of Commercial

Conference Call Participants

Geoff Meacham – Bank of America

Geoff Meacham

Welcome to the first morning of the BofA Healthcare Conference. My name is Geoff Meacham. I’m a senior biopharma analyst, and we are excited to have Bristol-Myers here. And Adam Lenkowsky is here, who recently was promoted to EVP, Head of Commercial. So congratulations.

Adam Lenkowsky

Thank you, Geoff. Great to be here.

Question-and-Answer Session

Q – Geoff Meacham

Let’s just kick off with that. Like so give us — as you evolve into the new role, you already know a lot of the commercial business around the world and different therapeutic areas. Give us kind of your — what would be your top 3 kind of list of priorities as you look to the back half of this year and into next?

Adam Lenkowsky

Sure. Well, for me, I’ve been with the company for 26 years now. So it’s really the most exciting time I think in our company’s history. When I think about my priorities coming into the role, number one, our strategy is unfolding nicely, which is really to replenish the portfolio. As you know, we’ve launched 9 new products in just over 3 years. And those products this year will roughly contribute about $4 billion of sales.

And what’s important about that is in 2025, we’re projecting those 9 new products to yield between $10 billion and $13 billion of sales. And then beyond 2030, approximately $25 billion. So really replenishing the portfolio and executing on these products is my top priority.

Secondly, when I look more at the near term, we just launched some of these new products last year. So best-in-class, first-in-class products, products like Opdualag, product like SOTYKTU and Camzyos. And so those launches are going very well, but we’re just starting to get those up and running outside of the U.S. as well.

And finally, when I think about kind of the next wave, we’ve talked about now introducing 6 new assets, moving them into Phase III. So a good example of what we’ve talked about in the past would be Milvexian. We just started all our Phase III study. So my job is working closely with the commercialization organization and our R&D organization to ensure that we’re ready to launch those products really in the back end of this decade. So those are my top 3 priorities.

Geoff Meacham

Got you. Well, let’s look at the new product portfolio. So Reblozyl is probably the — today, it’s the biggest one. And maybe longer term, it could be one of the biggest ones. So talk a little bit about the opportunity in first-line anemia and like sort of what you have in hand today and then the new indications that could get you to the next robust growth.

Adam Lenkowsky

So we’re pleased with what we’ve seen with Reblozyl. Really since we launched in the second line post ESA setting, the performance of Reblozyl has gone very well. Our shares are north of 70% in the market. So in the second-line setting, we’re focused on continuing to increase the dose as well as improve the time to switch from ESA to Reblozyl second line.

But the first-line opportunity for Reblozyl really poses a very significant opportunity, essentially doubles the addressable patient population, and we’re pleased that the FDA provided us with a priority review. So our new PDUFA data, our action date is headed towards the end of August, August 28. So that’s what our teams are focused on doing.

And I talked about outside of the U.S. as well. So we’ll also get ready to launch the first line sometime in the next year. And we look forward to sharing the data of the COMMANDS data at ASCO just in a few weeks from now.

Geoff Meacham

And we look at Reblozyl today from a commercial perspective. Give us some perspective on duration of therapy. I think that’s an underlying driver of a lot of these products that investors sometimes it’s harder to model if you have more of a chronic type of treatment versus an episodic.

Adam Lenkowsky

Yes. I mean that’s the key advantage, I think, that Reblozyl offers compared to ESAs. It’s really the durability of response, and you’ll see that data at ASCO through the COMMANDS study. What we’ve been able to do is we’ve increased the dose since we launched about 20%. And so that’s really helped keep patients on therapy longer, get a better response rate. So that’s really one of the significant advantages of Reblozyl over ESAs. And I think when you look at a product like Reblozyl and many of our new products, it’s largely derisked. So as we’ve guided that to $3 billion, essentially, it’s going to be predicated on second-line data, coupled with now COMMANDS, which would be the biggest opportunity for the brand around the world.

Geoff Meacham

And are there nuances OUS versus U.S. in terms of practice and how the — you could see the cadence of growth kind of accelerate?

Adam Lenkowsky

It’s just timing of reimbursement is really the difference. The behavior and the treatment is largely the same. And the focus of — in the second-line setting pushing the dose up and rapid switch is — that’s one area. I guess I would say the only nuance in the label outside of the U.S. when you think about our European label, it is also indicated for patients who are in-able — or unable to take ESAs. It’s about 10% of the population who just are unable to handle ESA. So we are — in that case, in essence in a first-line setting in some of those markets.

Geoff Meacham

So you mentioned Opdualag, and that’s had a fantastic launch, very good initial feedback from oncologists, some — talk about the kind of the switch factor. Do you see that as much from Nivo-ipi to Opdualag? And then when you look at over the course of this year in the U.S., is it just more executing on the core melanoma market? Or are there new kind of drivers here?

Adam Lenkowsky

Yes. Yes. I mean, we’re really pleased with what we’re seeing with the Opdualag launch. What we have shared at our last earnings, our market share for Opdualag is now hovering between 22% and 23% of the total melanoma marketplace, and we expect to continue to grow that.

Now we do have an opportunity now for growth that has just emerged where the NCCN has removed BRAF/MEK inhibitors, which has been really the foundation of first-line treatment as a Category 1 and replaced that with Opdualag and Opdivo-Yervoy because of Mike Atkins’ Dream Seek data, which clearly showed that using Opdivo, Yervoy or Opdualag, first is better and then sequencing to BRAF/MEK in the mutant population.

When I think about how our share breaks down, we have about a 10% share for Opdualag in the BRAF mutant setting. So there’s significant opportunity to continue to penetrate in BRAF mutant now through the end of the year. And also, when I think about the switches where we are, we’re seeing about 2/3 of the switch is coming from monotherapy. And when you just look at Opdualag compared to Opdivo mono and KEYTRUDA mono, our share is higher than those 2 monotherapies combined now.

Geoff Meacham

And can you talk about the — I know it’s early, but the European kind of the expectations for — how should we think about the cadence of that rollout?

Adam Lenkowsky

Yes. Obviously, we’re disappointed that we were unable to launch in Germany. We announced that unfortunately, the new AMNOG rules just didn’t recognize the innovative value that Opdualag brings to patients, and that’s really a shame for melanoma patients in the market.

Now we still have an opportunity to continue to launch outside of the U.S., and that’s what we’re focused on doing. Our goal is to make sure that Opdualag is available to as many patients as possible. However, we need to make sure that also that the innovation is recognized. And so we’re going to continue to work with G-BA AMNOG to try to get back in and renegotiate that. And as we look to future indications for Opdualag, so essentially, the next few data readouts would be in adjuvant melanoma, where we have a Phase III study or in second-line CRC, we think we’ll have an opportunity to really get broad adoption around the world.

Geoff Meacham

And from a mechanism, so LAG-3, the — you mentioned a couple of indications, but broadly lung is obviously the bigger market. What’s your confidence in broadening out down the road, the profile here? I wasn’t sure where the science takes you on LAG-3 over [indiscernible].

Adam Lenkowsky

Well, that’s why you do the experiment, I think, right? So I think we have — we do know that relatlimab or LAG-3, combined with OPDIVO is active across a myriad of tumors. And so we are testing beyond the indications that I named in Phase III. We’re testing it in liver cancer, in HCC. We’re testing it in lung cancer as well. And we’ll get that data really in the beginning of next year, and then we’ll be able to make informed decisions on how we want to proceed with registrational studies and where we want to place that in terms of lines of therapy.

Geoff Meacham

And Adam, if you step up the conversation to look at fixed dose combinations with Opdivo, Opdualag obviously is such that. But if you look at other IO/IO combinations, so is this something that you would say Bristol is part of a key strategy is to develop more IO/IO combinations that are same idea, like fixed dose, subcu, like easy to take? Is that part of life cycle extension of the Opdivo business?

Adam Lenkowsky

Well, for me, I spent about half of my career in oncology at BMS, launching Yervoy, launching Opdivo. And so a core pillar of our strategy has been IO/IO combinations. We’re the only company out there now with 3 IO mechanisms particularly for PD-1 and, of course, LAG-3. And so we’ve been testing a number of different combinations. We’ve got other IO agents under development like TIGIT. As I mentioned, Opdualag is going to be — continue to look at across a host of other indications.

However, I wouldn’t say that we are solely focused or dramatically focused on IO/IO. We’re looking at combinations with chemotherapy, combinations with TKIs, combinations with targeted therapies. And we’ll continue to follow the science and identify the best places where patients have the opportunity for the greater response. And another area of focus for us is really to identify biomarker specific strategies to see where we you can receive the highest response rate and the longest durable survival benefit.

Geoff Meacham

Got you. And looking outside of the IO/IO combinations from a technology perspective, so gene and cell therapy. So let’s talk a little bit about Abecma and Breyanzi. Bristol is one of the largest companies in the cell therapy space. Give us a status update of where we are with respect to manufacturing capacity issues and other in the past, there’s been some vector considerations when we model.

Adam Lenkowsky

I get more and more excited about our opportunity in cell therapy, both in the near term and the long term. I think this is a market that’s going to grow significantly. We’re projecting the market can grow to over $25 billion at peak. And similar to what we see in the IO dynamic, I think there are going to be just a few companies really poised for success. And I think that BMS is really in that pole position with starting with our products, which we think are best in class like Breyanzi, which we know has a differentiated safety profile. Abecma, we’re excited to share our KarMMa-3 data, performing very well in the marketplace today. And our next wave of CAR-T agents and cell therapies.

So GPRC5D, which we have in the clinic today. Our next key agent, which we’re looking at even beyond hematologic malignancy into lupus. And that’s really where you can look at really expanding this market as well as we also have a biospecific as well. And so when you think about what we’ve been able to do over the last several years, it really is ramping up our capacity.

You saw that in Q1 where we sold about $200 million — over $200 million of combined CAR-T sales. And so we’re focused on 3 areas as it relates to increasing capacity. Number 1 is reliability. And so we think we’ve done a really nice job there, and that includes out-of-spec turnaround time. The second is increasing vector, as you said. And so we are doing that, looking internally and externally for vector. We just put a press release out about acquiring a site in Libertyville, Illinois to produce Vector. So that should increase our Vector capacity through the next several years starting in 2025.

And then finally, it really is around drug product, and we’ll have Devons and Massachusetts online by the end of this year. And for a European business, we’ll have Leiden online by the beginning of 2025. So again, those 3 areas, you’re going to continue to see us improving capacity across both of our assets over the coming years.

Geoff Meacham

And when you look at the U.S. sort of infrastructure for cell therapy for CAR-T, where do you think we are today with regard to making it more seamless and centers being able to have — be able to handle the higher volume of patients? I’m just trying to get a sense for — in the adoption curve, are we second inning? Third inning? Are we still back in the first?

Adam Lenkowsky

No. I think we’re probably in the second inning, honestly. We’re really early in the journey. And what I could tell you not just for BMS, but what we’re seeing in general, clearly, the demand for these products is significantly outstripping the supply.

And as our products continue to move earlier and earlier in treatment, they’re going to need to find new ways to manage these products. So it really isn’t about the capacity of the institutions at this point. They want to have more slots. I mean that’s what they tell us. And we’re working every single day with our manufacturing team to increase the supply, so we can get these to as many patients as possible. There is, I think, a future where these products — not everyone, but think about a product like Breyanzi with the safety profile that it offers, is a desire to use this in the outpatient setting.

So today, we’re looking at about 15% to 20% of outpatient use relatively low. Most of it is still in the academic medical centers. But I could see a world when you look at particularly CD19 agents with clean profile, then I do feel like you’ll see more and more outpatient use, and that also will help with any capacity constraints in the institutions.

Geoff Meacham

Yes. And outside the U.S., are we with respect to sort of the infrastructure and be able to infuse patients, right? I mean — is that — we even started the game before in the first inning in the U.S.?

Adam Lenkowsky

No, no. We’re probably in the first inning there. But I would say — and before I was appointed at CCL, I was running our international business. And when I look at what we’ve been able to do in Japan, in Germany, in France, 3 of the largest markets outside of the U.S., we’re seeing very similar dynamics with Breyanzi and Abecma. In fact, I think that a market like Japan could possibly be the second largest market in the world for CAR-T. They really want to adopt this. We’ve talked a lot in the past about some of the challenges of access and reimbursement outside of the U.S. We’ve been very, very pleased with what we’ve been able to see in those markets and around. They are recognizing the innovative nature that these products are bringing and the adoption outside of the U.S. has been very strong.

Geoff Meacham

You mentioned lupus and a number of other indications. So you guys are one of the companies that are not going down the pure hematology-only path here. The gene therapy, cell therapy as a platform has broad applicability. But help us with how much of a priority going into things like solid tumors or autoimmune or things like that? Like are there indications beyond just lupus that you’re thinking about longer term?

Adam Lenkowsky

Yes. So the first priority right now is continuing to drive earlier lines in he-malignancies. You see that in second-line DLBCL. We’re going to look at earlier line multiple myeloma with Abecma and starting that study in the back end of the year. That’s really the first pillar of the strategy.

We are certainly exploring outside of he-malignancies, as I mentioned, not just in lupus, but in broader immunologic diseases, because we do think that there could be a really nice efficacy benefit there. And the ability to just give one CAR-T [indiscernible] to be and done and potentially have a cure in some of these very challenging to treat diseases. We think that is not just the possibility, we think that will be a reality in the longer term.

Now of course, we know that the Holy Grail is, can you crack into the solid tumors? And there’s been some evidence that you can. There have been a few tumors that seem to be more sensitive than others. But I think that may be a longer way to weigh at this point.

Geoff Meacham

And the risk from alo, is that something that you guys are working on? How do you view that perspective?

Adam Lenkowsky

I think we have — we’re tackling from multiple mechanisms. I talked about earlier. I did — I think number one, I think about BCMA as a target. Clearly, there’s importance around BCMA utilization. I think CD19 is already recognized as best-in-class safety. Yes, I do think off the shelf, they do bring some benefits, but what we see today even with “off-the-shelf” there are some limitations. You have to be in the hospital for 10 days. So I think that right now, we’re looking at these kind of, let’s call them, first-generation cell therapies are going to be here for the long term. And then maybe in the back end of the decade, you’ll start to pivot to newer technologies that may be easier to manufacture and quicker to get into patients.

Geoff Meacham

Got you. Well, let’s go down the line of the new launch portfolio. So SOTYKTU, great indication or great label. Help us with kind of the access today and how you’re thinking about going into next year with — now that you have good share, but there’s a good familiarity. But what are the next steps to kind of in the U.S. launch?

Adam Lenkowsky

So very, very happy with the way that the SOTYKTU launch is unfolding. We talked about SOTYKTU being the oral standard of care as you just alluded to, our share of orals right now is approaching 40%. So OTEZLA being 60%, and so we think we were poised to pass them by the end of the year based on what we’re seeing today, the enthusiasm in the marketplace.

When you actually look at the broader market, with new to brand share, which is what we look at are — we’re actually ranked #3 in terms of total market share behind only that of SKYRIZI and OTEZLA, which is incredibly impressive since we’re not even a year in the marketplace. But as I said, as it relates to active, it takes time for products in this class to gain access.

On average, when you look at analogs in the class, takes about 18-or-so months to get open access. Our goal is to try to pull forward some of that access based on the demand that we’re generating, and that’s that the PBMs want to see that you’re generating demand, which we are doing. We also want to make sure that we’re not taking out unnecessary discount early on in the life cycle. So we want to be prudent with how we approach payers, but we understand that we want to make sure that this product is available, easy to access.

So today, most of our patients are coming into our hub. We get to push some patients out to commercial, but generally, we’ll carry these patients until we either have access or until they’re switched from another agent. But we expect to have broader access position in the beginning of next year in January. The decisions that PBM takes, they’re pretty formulaic. I mean it’s not never say never in terms of can you get a product launch and they’ll immediately put it into a preferred position, can happen, but it really is the exception, not the rule. Usually, they review the class once or twice a year. This is a very competitive class.

So typically, these decisions are made in the fall for the following January. So our — we’re pleased with how the launch is progressing, and our focus now is really continue to drive demand, continue to drive breadth and depth of prescribing.

Geoff Meacham

I know you guys have invested in DTC campaigns and give us a sense of — for the level of awareness among physicians and then the level of awareness with the head-to-head data versus OTEZLA.

Adam Lenkowsky

The teams have done a phenomenal job. I’ll give credit to our medical teams, even prior to the launch, making sure that they’re aware of this new mechanism. Remember, this is the first TYK2 agent that’s approved in any disease state. [Technical Difficulty] So our awareness with physicians is probably close to 90%, very, very high, and that’s on unaided basis. So that’s not our challenge, and physicians understand the profile. They really like the label. They’re pleased with the label that we received, and they’re confident in the efficacy profile versus OTEZLA as well as the safety profile.

Now as it relates to patients, the reason why you do DTC campaigns is to really educate patients and get them to go into their doctors to ask for the prescription because when a patient goes in and asks for a prescription, the large majority of the time, they’re going to get that prescription that they asked for. And so that’s why we do it, and we’ve seen some really early promising metrics from the SOTYKTU DTC campaign.

Geoff Meacham

Indications outside of psoriasis, looking to IBD, give us a perspective on your — kind of your confidence level at expanding the indication base, so over the next say couple of years.

Adam Lenkowsky

Yes. So we have started our Phase III study in SLE as well as in PSA. And so as we’ve guided the $4 billion-plus number for SOTYKTU, those are the indications that comprise the $4 billion-plus peak revenue. And so it’ll be exciting to have an opportunity to potentially get approval into SLE or lupus, which we know have been very difficult area to crack. And we have, as I said, we’ll be looking at our next CAR-T as well. So we have multiple opportunities to get into lupus. PSA is also an exciting adjacency, I would say, to our PSO indication.

As it relates to IBD, as we’ve shared on our earnings call, we didn’t see enough in terms of proof of concept in Crohn’s disease to decide to move that forward. And then when you look at where we are in ulcerative colitis, we’ll get that data probably towards the back end of this year when we can just make a more informed decision on do we want to move forward in that. I think just a couple of things are noteworthy. Number one, those indications in IBD are not in the $4 billion-plus guidance. And when you look at where we are today, PSL will represent the large majority, I think, of the $4 billion plus in sales.

And secondly, I think when you look at the IBD market on its own, I mean in order to get into that market today, where there are biosimilars where it is heavily managed class, you do need to bring products in there that are highly differentiated or have biomarker specific opportunities to look at what patients are the right ones for these drugs. So we’re going to continue to interrogate that, and there may be actually opportunities as we move forward. We just need to see how the data turns out.

Geoff Meacham

Right. Let’s switch gears to Camzyos. You guys have a lot of products, so we’ve got to do some quick hits. So when you look at the launch experience so far, what would you characterize is the tipping point? Is it awareness? Is it consistency in converting patients from trial to commercial? Is it payer negotiations?

Adam Lenkowsky

Yes. So great question. I mean, remember, we just celebrated the 1-year anniversary of the Camzyos approval. And I think the first thing is just setting expectations on what a CV launch looks like compared to what we talked about with what like an Opdualag launch could look like. And you generally see a nice, gradual, steady increase over time with very long time to peak, which is incredibly healthy place to be.

Last year, upon launch, this is an area, unlike what we talked about with SOTYKTU where poor awareness of the disease, tremendous amount of misdiagnosis, diagnosis rates around 25% in HCM. And so we spent a lot of time last year just building the infrastructure, making sure that physicians were REM certified. We now have over 3,300 physicians who are REM certified.

Those 500 accounts, getting them ready to operationalize and have patients come. And what I’m really pleased to see is consistent week after week, quarter after quarter, we are starting to see increase in the number of patients, increases in physician prescribers. In these 500 accounts, they’re highly penetrated in the 100 of those 500 accounts, which really comprise the — those are the highest and most significant HCM centers of excellence. We’ve got almost 100% penetration.

So now it’s around driving depth of penetration. And to your question around any — what are barriers, what are challenges, there does not seem to be any access challenges as it relates to Camzyos. We’re pleased with what we’ve seen there. Of course, you see prior authorizations to label. But beyond that, there’s no other issues. I think the biggest challenge we face is the fact that when you look at the diagnosed patients, they may show up at a physician’s door in these centers of excellence 1, 2, 3 times a year. So they don’t come, as we’ve said, all at once. And so it’s really making sure that we’re getting those patients once they’re in the doctor’s office, putting them on Camzyos. And we’ll continue to see that build over time.

Geoff Meacham

Got you. And on your legacy products, so if we switch gears to OPDIVO, you’ve had some success commercially, and you’ve seen an inflection from earlier use and GI gastric indication. So looking out in the next, say, 12, 18 months, what are the drivers in the U.S. and Europe that in terms of label expansion or new tumor types?

Adam Lenkowsky

Yes. Very pleased with OPDIVO. As you saw, we showed 18% growth in the quarter. We expect that to continue to grow in double digits over time. We have a host of new indications. As you said, the near-term growth is continuing to come from first-line lung, where our share now has reached 15% in the U.S., continues to come from gastric cancer. Our share is over 50% adjuvant bladder. So these are the real drivers of the opportunity as well as renal cell carcinoma.

The next set of opportunities really now are in the earlier stages of the disease. We’re currently, I think, leaders in that space today with some indications added to melanoma, adjuvant esophageal cancer, adjuvant bladder. And our next indications will be in Stage 2 melanoma. We have data readouts coming out in lung cancer in the periadjuvant/adjuvant stage. We have data coming out in prostate cancer. So you’ll start to see those read in the next, really, 12 to 18 months.

Geoff Meacham

Got you. Okay. When we go to some of the legacy products, LOE products, so on the Revlimid cliff, when you think about the cadence of the generic erosion, what are the puts and takes for this year? And is the decline in line with what you guys were thinking about with regard to having the certain volumes coming from the authorized?

Adam Lenkowsky

So we have guided that we will sell approximately $6.5 billion this year. And over the next 2 years, we’ll see approximately a $2.5 billion step down each year until you get to 2026, then you have full generics in the market. So Rev continues to be a significant cash and profit contributor to our bottom line.

When we think about what we’ve been seeing and what we control and what we don’t control. So we know how much the generic companies are able to sell into the channel. And so what we’ve said was each year, we’re looking at about a $2.5 billion step-down. What we saw — if you remember at the end of last year, we saw favorability of about $500 million, because there were fewer sales coming into the channel.

First quarter, we saw actually some unfavorability, because although we know how much is coming in on an annual basis, we don’t know the quarterly cadence of that because they sit within the specialty pharmacies. And that’s something that’s not in our control. Whether they sit on the product, whether they dispense the product. And that’s why you’ll see continued variability from quarter-to-quarter. One quarter will decline. One quarter, we may show significant increases, but we do have a good sense as to what the annual impact is going to be.

Geoff Meacham

Fantastic. So it’s a sprint to get through all the products. We did it. Yes, we did it. So thank you for the time. Really appreciate it.

Adam Lenkowsky

Thank you so much. Thanks for having me.

Bristol Myers Squibb (BMY Quick QuoteBMY – Free Report) and partner 2seventy bio, Inc. (TSVT Quick QuoteTSVT – Free Report) announced that the FDA has accepted the companies’ supplemental biologics license application (sBLA) for CAR T cell therapy Abecma (idecabtagene vicleucel).

The regulatory body has set a target action date of Dec 16, 2023.

The sBLA was based on interim results of the phase III KarMMa-3 study, the first and only randomized, controlled study designed to evaluate a CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma, in which Abecma significantly reduced the risk of disease progression or death versus standard regimens.

The study enrolled patients who were treated with an immunomodulatory agent, a proteasome inhibitor and daratumumab, which are the commonly used standard treatments in multiple myeloma.

The company is seeking approval of the therapy for earlier lines of treatment.

The European Medicines Agency (EMA) has also validated the Bristol Myers type II variation application for Abecma based on the KarMMa-3 study.

In addition, Japan’s Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s new drug application (sNDA) for Abecma based on the KarMMa-3 study.

A potential approval will make this anti-BCMA CAR T cell therapy a standard of care earlier in the treatment course for relapsed and refractory multiple myeloma.

Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio. The former assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S.

The development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3 and KarMMa-9) in earlier lines of treatment for patients with multiple myeloma.

In the past year, BMY’s shares have lost 8.2% compared with the industry’s fall of 11.3%.

Image Source: Zacks Investment Research

In February, BMY reported better-than-expected results for the fourth quarter of 2022. Total revenues of $11.4 billion decreased 5% from the year-ago period due to generic competition for multiple myeloma (MM) drug, Revlimid and foreign exchange impacts, partially offset by in-line products (primarily Opdivo) and new product portfolios (primarily Opdualag and Abecma).

The approval of potential new drugs and label expansion of existing drugs will add an incremental revenue stream to boost growth in the coming quarters and offset the slowdown in top-line growth as one of Bristol Myers’ top drugs, Revlimid, is now facing generic competition, which is affecting the top line and threatens to erode sales rapidly.

The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (EC). Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO Quick QuoteNVO – Free Report) and Ligand Therapeutics (LGND Quick QuoteLGND – Free Report) , both sporting a Zacks Rank #1 at present.

In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.43 to $4.52. Estimates for 2024 have increased 7 cents to $5.26.

Ligand’s earnings per share estimates for 2023 increased to $4.15 from $3.30 in the past 60 days. LGND beat earnings estimates in one of the last four reported quarters.

In the past I have published articles about pharmaceutical companies on a regular basis and one of the recurring themes in these articles was the resilience in case of a recession – this is including recent articles about AbbVie Inc. (ABBV) as well as Amgen Inc. (AMGN). And it seems like the crisis is accelerating with several banks on both sides of the Atlantic being in severe trouble or collapsing already.

Another major pharmaceutical company, which is not only among the 100 largest companies in the world by market capitalization but also among the 10 major pharmaceutical companies, is Bristol-Myers Squibb Company (NYSE:BMY). In theory, we can assume that BMY is also a good pick during a recession and economic decline as it is fitting the pattern. And as my last article about Bristol-Myers Squibb was published about one and a half years ago it seems time for an update.

Recession-Resilient?

Let’s start by asking the question how recession-resilient Bristol-Myers Squibb is. Usually, pharmaceutical companies perform very stable during recessions as the demand for the products is staying at similar levels (or even increases). The drugs pharmaceutical companies are selling can be classified as necessary and essential products for the patients and as a necessity for their daily lives. Therefore, it is not surprising these drugs are purchased independent from the economic situation.

When looking at Bristol-Myers Squibb we can see a similar performance in the last decades, but I would be a bit cautious and certainly not call the company recession-proof. While we see no reaction to the early 1990s recession or the COVID-19 crash in 2020, we see a steep decline of 25% during the Great Financial Crisis. And earnings per share also show a clear reaction to most recessions in the past – however, this is the case for most companies and should not be overrated. We can assume Bristol-Myers Squibb performing quite stable during the next recession, but I wouldn’t bet on it.

Messed Picture In The Past

And while Bristol-Myers Squibb can’t be described as completely recession-resilient (or recession-proof), the stock is also presenting a mixed and rather messed up picture in the last two decades. When looking at the last ten years, Bristol-Myers Squibb clearly underperformed the S&P 500 (SPY) – instead of 206% increase for the index, Bristol-Myers Squibb increased only 123%.

And when looking at the last few decades the performance was not so great – including the stock performance during recessions. While during some recessions the stock price was extremely stable and hardly declined at all, we saw steep declines around 2000 and during the Great Financial Crisis.

Additionally, it took BMY almost two decades before the stock could reach its pre-Dotcom-bubble highs again. And part of the explanation for the steep decline in the years around 2000 were the high valuation multiples before. In 1999, BMY peaked at 50 times earnings and in 1998, the P/FCF ratio was as high as 64. And these are without much doubt unjustified valuation multiples for almost any business – especially for a pharmaceutical business which is highly dependent on research and development and introducing the next blockbuster.

And when comparing Bristol-Myers Squibb to many other major pharmaceutical companies, the performance since 2000 is a disaster. Even when excluding outperformers like Gilead Sciences (GILD) which increased 4,630% in value since 2000 and Novo Nordisk (NVO), which could even gain 5,810% in value – in both cases not including dividends, Bristol-Myers Squibb is still underperforming most other major drug companies. Even Pfizer, Inc. (PFE) could increase its stock price by 31% while Johnson & Johnson (JNJ) increased 228% and Amgen Inc. (AMGN) increased 296%.

Full Year Results

While past results are certainly important and tell us important aspects about a business, we should look at the present and the future to make a good decision about a business and whether we should invest in it.

We can start by looking at the results for fiscal 2022 – and they were not great. Total revenue declined slightly from $46,385 million in fiscal 2021 to $46,159 million in fiscal 2022 – a decline of 0.5% year-over-year. Earnings before income also declined 4.8% year-over-year from $8,098 million in the previous year to $7,713 million in fiscal 2022. And finally, diluted earnings per share declined from $3.12 in fiscal 2021 to $2.95 in fiscal 2022 – a decline of 5.4% YoY.

Only adjusted, non-GAAP earnings per share could increase 7.5% YoY from $7.16 in the previous year to $7.70 last year.

And for fiscal 2023, management is expecting total sales to increase about 2%, while GAAP earnings per share are expected to be in a range between $4.03 and $4.33 – resulting in about 36% to 46% growth. Non-GAAP earnings per share are expected to be in a range between $7.95 and $8.25 – resulting in about 3% to 7% YoY growth.

Product Sales

When looking at the different products and sales, we can start by looking at Revlimid, which is one of the reasons Bristol-Myers Squibb is struggling and had to report a declining top line. With patents expiring in March 2022, sales declined from $12,821 million in fiscal 2021 to $9,978 million in fiscal 2022. And for 2023 management is expecting the decline to continue with Revlimid contributing only about $6.5 billion in revenue.

To replace the declining sales from this blockbuster (Revlimid was responsible for almost 30% of revenue in 2021), Bristol-Myers Squibb is focusing on its “New Product Portfolio”, which generated $2,030 million in revenue and compared to $1,083 million in revenue in the previous year it could report 87% year-over-year growth. Growth was especially driven by the launch of Opdualag, which generated $252 million in sales in 2022 and which is expected to reach peak sales of $4 billion.

Additionally, higher demand for Abecma, which could grow sales by 137% to $388 million in fiscal 2022 and the higher demand for Reblozyl, which could increase sales 30% to $717 million, contributed to growth.

And management is extremely confident that its New Product Portfolio will grow with a high pace in the years to come. For 2025 management is expecting sales from these new products to be between $10 billion and $13 billion and for 2030 it is expecting $25 billion or more in sales.

And the four new blockbusters – Camzyos, Opdualag, Sotyktu and Reblozyl – are each expected to contribute about $4 billion in annual revenue. Sotyktu has just been launched and generated only $8 million in revenue in Q4/22 and Camzyos was also launched in 2022 and generated $24 million in fiscal 2022.

And not only the new product portfolio will contribute to growth in the years to come. In-line brands – primarily immunology and oncology (for example Opdivo which generated $8,249 million in sales in 2022) as well as Eliquis, which generated $11,789 million in sales in fiscal 2022, will contribute to growth. These in-line brands are expected to contribute between $8 billion and $10 billion in additional revenue until 2025.

Overall, this should lead to a more diversified portfolio for Bristol-Myer Squibb by replacing several well-established drugs which are close to patent expiration with newer drugs that can rely on patent protection for several years.

Balance Sheet

Let’s also take a look at the balance sheet, which is not perfect but also no reason for worries about solvency or liquidity. Before Bristol-Myers Squibb acquired Celgene, the company had a good balance sheet with rather low debt levels and cash as well as cash equivalents more or less equal to the company’s debt levels.

However, the acquisition increased total debt to almost $50 billion. In the last few quarters, BMY is reducing debt levels again and on December 31, 2022, the company had $4,264 million in short-term obligations as well as $35,056 million in long-term debt on its balance sheet. When comparing the total debt to the total shareholder’s equity of $31,118 million, we get a still acceptable D/E ratio of 1.26. However, when comparing the total debt to the operating income of $9,879 million in fiscal 2022, it would take almost 4 years to repay the outstanding debt – a metric that is still acceptable, but rather high. Of course, we should take into account the $9,123 million in cash and cash equivalents that could be used to repay outstanding debt reducing the time it would take to only about 3 years.

When talking about the balance sheet, we should also mention $35,859 million in intangible assets and while high amounts of intangible assets are rather typical for pharmaceutical companies, $21,149 million in goodwill are not great. However, compared to $96,820 million in total assets, the amount seems acceptable.

Intrinsic Value Calculation

A final step in every analysis is determining an intrinsic value for the stock or determining in some other ways if the current stock price is matching the fundamentals and as a result make a buying decision. I usually determine an intrinsic value by using a discount cash flow calculation, which is the most accurate in my opinion but has one major shortcoming: We must make several assumptions about free cash flow a company can generate in 5 years or 10 years from now and nobody can make precise predictions for free cash flow several years into the future. To compensate, we should include a margin of safety into our calculation as well as provide several different scenarios and not succumb to the illusion of being able to determine a precise intrinsic value for a stock.

As starting point we can usually take the free cash flow of the last four quarters, which was $11,950 million. And when taking a 10% discount rate as well as 2,124 million outstanding shares, Bristol-Myers Squibb must grow its free cash flow only about 2% annually to be fairly valued – a target that seems reasonable and certainly achievable. Management is more optimistic and expecting low-to-mid single digit growth rates, so let’s calculate with a still moderate growth rate of 4% instead – this leads to an intrinsic value of $93.77 for the stock.

While we should not worry about the company being able to achieve 2% or 4% growth in the years to come – these are rather moderate and achievable targets – we should take a closer look at the current free cash flow and especially the cash conversion rates.

	2018	2019	2020	2021	2022
Net Income	$4,920 million	$3,439 million	($9,015 million)	$6,994 million	$6,327 million
Free cash flow	$6,115 million	$7,374 million	$13,299 million	$15,234 million	$11,948 million
Cash conversion rate	124%	214%	N/M	218%	189%

Click to enlarge

And in the last few years, BMY was reporting extremely high conversion rates. What might sound like good news at first could also be a warning sign that these conversion rates – and therefore free cash flow – are not sustainable. On the other hand, other pharmaceutical companies are able to generate an even higher percentage of sales as free cash flow – Gilead Sciences has a ratio around 30%, Amgen has a ratio of 33% and Novo Nordisk even a ratio of 36% right now.

Conclusion

Bristol-Myers Squibb is presenting itself rather mixed. For starters, the share price seems low enough not to be bearish about BMY. Additionally, the balance sheet is not perfect and the performance in the last two decades is off turning.

However, I think I will turn bullish about Bristol-Myers Squibb as the company seems to be able to grow with a solid pace in this decade. And the growth story presented – especially by the New Product Portfolio – sound convincing to me. And although Bristol-Myers Squibb has a mixed performance in past recessions, I am confident it will perform quite well in 2023 and 2024. Of course, one can also make the case for Bristol-Myers Squibb being deeply undervalued – especially if the company is able to grow its free cash flow not only in the very low single digits, but maybe in the mid-single digits. In this case, the intrinsic value could be $100 or higher.

Bristol Myers Squibb (BMY Quick QuoteBMY – Free Report) came out with quarterly earnings of $1.82 per share, beating the Zacks Consensus Estimate of $1.71 per share. This compares to earnings of $1.83 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of 6.43%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.83 per share when it actually produced earnings of $1.99, delivering a surprise of 8.74%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Bristol Myers, which belongs to the Zacks Medical – Biomedical and Genetics industry, posted revenues of $11.41 billion for the quarter ended December 2022, surpassing the Zacks Consensus Estimate by 2.37%. This compares to year-ago revenues of $11.99 billion. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock’s immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management’s commentary on the earnings call.

Bristol Myers shares have lost about 1% since the beginning of the year versus the S&P 500’s gain of 7.3%.

What’s Next for Bristol Myers?

While Bristol Myers has underperformed the market so far this year, the question that comes to investors’ minds is: what’s next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company’s earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Bristol Myers: mixed. While the magnitude and direction of estimate revisions could change following the company’s just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $2.02 on $11.77 billion in revenues for the coming quarter and $7.90 on $47.1 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical – Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Denali Therapeutics Inc. (DNLI Quick QuoteDNLI – Free Report) , another stock in the same industry, has yet to report results for the quarter ended December 2022.

This company is expected to post quarterly loss of $0.77 per share in its upcoming report, which represents a year-over-year change of -24.2%. The consensus EPS estimate for the quarter has been revised 1.1% higher over the last 30 days to the current level.

Denali Therapeutics Inc.’s revenues are expected to be $8.03 million, down 35.8% from the year-ago quarter.

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 23, 2021.

“While stem cell transplants are an effective treatment for aggressive leukemias and other hematological malignancies, patients who receive stem cell transplants from unrelated and human leukocyte antigens (HLA)-mismatched donors are at high risk for developing aGvHD,” said study lead investigator Leslie Kean, M.D., PhD, Director of the Pediatric Stem Cell Transplantation Program, Boston Children’s Hospital/Dana-Farber Cancer Institute. “There is a tremendous need to expand the stem cell donor pool by lowering the risk of aGvHD in both adults and children receiving unrelated donor stem cell transplants.”

Stem cell transplants include infusion of donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient’s body, including cancer cells. GvHD occurs when the donor T-cells also recognize the patient’s healthy cells as foreign and start attacking healthy tissues and organs. To initiate this attack, T-cells require activation through a signaling process called co-stimulation. Between 30 and 70 percent of transplant recipients develop aGvHD, depending on donor type, transplant technique, and other features. Orencia, a therapy currently approved to treat various arthritic conditions, binds to and inhibits protein targets involved in co-stimulation, thus inhibiting T-cell activation.

“For patients who receive unrelated donor stem cell transplants, in particular for racial and ethnic minority patient populations, there is a heightened risk of developing aGvHD, a potentially life-threatening medical complication for which there are no approved preventive therapies,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We look forward to working with the FDA to bring Orencia to this new patient population and employ pathbreaking science in an effort to address unmet needs of underserved patients.”

The sBLA submitted to the FDA is based on results from the Phase 2 ABA2 trial and a registry trial based on real world evidence. The ABA2 trial assessed the impact of Orencia on the prevention of severe aGvHD, when added to a standard GvHD prophylactic regimen administered to patients with hematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor. A mismatch in HLA increases the risk of GvHD. Results from ABA2 showed that treatment with Orencia resulted in a significant reduction in severe aGvHD and associated morbidity without an increase in disease relapse. The findings of the real-world analysis were consistent with those of ABA2.

Bristol Myers Squibb thanks the patients and investigators who participated in this clinical trial.

About ABA2

The ABA2 study was a multicenter, Phase 2 investigator sponsored trial conducted by Dr. Leslie Kean of Boston Children’s Hospital/Dana Farber Cancer Institute. ABA2 had two cohorts: a single arm cohort for patients receiving transplants from mismatched unrelated donors (MMUD) (“7/8” cohort), and a randomized, double blind, placebo-controlled cohort for patients receiving transplants from 8/8 matched unrelated donors (MUD) (“8/8” cohort). All subjects received a calcineurin inhibitor (CNI), with dosing starting on day -2 and continuing through at least Day 100 as tolerated, and methotrexate (MTX) on days one, three, six and 11 (transplant day is Day 0). Orencia-treated subjects received 10 mg/kg Orencia on days -1, 5, 14 and 28.

In the ABA2 clinical trial, addition of Orencia to SOC aGvHD prophylaxis of MTX+CNI resulted in a significantly higher aGvHD-free survival (GFS) rate compared to registry controls in the single-arm 7/8 HLA-matched cohort, and numerically higher severe GFS rate in the double-blind, placebo-controlled 8/8 HLA-matched cohort at 180 days post-transplant.

About Acute Graft Versus Host Disease and Impact on a Diverse Patient Population

Graft versus host disease (GvHD) after a hematopoietic stem cell transplant occurs when transplanted donor T-cells recognize antigenic differences between the donor and the recipient, and attack the recipient’s healthy tissue and organs. Acute graft versus-host disease (aGvHD) impacts between 30 and 70 percent of patients, depending on donor type, transplant technique, and other features, with racial and ethnic minority patient populations more likely to experience challenges following a hematopoietic stem cell transplantation. This may be due to several factors that impact overall outcome, including a lack of donor availability and related care. This activation of T-cells can result in severe immune-mediated tissue damage to the host, with the skin, liver and gastrointestinal tract being the most common targets. aGvHD-mediated damage to these vital organs has been associated with increased morbidity and death.

HSCT is an effective treatment for aggressive leukemias and other hematological malignancies, often representing the only option for cure. However, some of its benefit, especially in the case of unrelated donor transplantation, is offset by a high rate of transplant-related mortality (TRM) stemming largely from severe aGvHD and infection.

About ORENCIA^®

ORENCIA^® is an immunomodulator that disrupts the continuous cycle of T-cell activation.

U.S. Indications/Usage and Important Safety Information for ORENCIA^® (abatacept)

Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA^® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA^® (abatacept) is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Adult Psoriatic Arthritis: ORENCIA^® (abatacept) is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Important Safety Information for ORENCIA^® (abatacept)

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In post marketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please click here for Full Prescribing Information.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Orencia (abatacept) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that a Priority Review designation does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II Variation Marketing Authorization Applications (MAA) for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). Validation of these applications confirm that the submissions are complete and begins the EMA’s centralized review process.

“Outcomes for patients with advanced esophageal squamous cell carcinoma treated with chemotherapy alone remain poor, and there is a clear need for additional options beyond this long-standing standard of care,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “The validation of our applications moves us a step closer to potentially bringing these two Opdivo-based regimens to patients in the EU who may benefit.”

The applications are based on results from the pivotal Phase 3 CheckMate -648 trial, in which both Opdivo-based treatment combinations — Opdivo plus Yervoy and Opdivo plus chemotherapy — demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy at the pre-specified interim analysis in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. Opdivo plus Yervoy is the first dual immunotherapy combination to demonstrate a superior survival benefit versus chemotherapy in this setting. The safety profiles of Opdivo and chemotherapy and of Opdivo plus Yervoy were consistent with the known safety profiles of the individual components.

Results from CheckMate -648 were presented in an oral session during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and were selected for the official ASCO press program.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -648 trial.

About CheckMate -648

CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy or Opdivo plus fluorouracil and cisplatin against fluorouracil plus cisplatin alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma. The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1 ≥1% for both Opdivo-based combinations versus chemotherapy. Secondary endpoints of the trial include OS and PFS by BICR in the all-randomized population.

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity. In the Opdivo plus chemotherapy arm, patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² on Day 1 of four-week cycle. Patients received Opdivo for up to 24 months or until disease progression or unacceptable toxicity, and chemotherapy until disease progression or unacceptable toxicity.

About Esophageal Cancer

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal squamous cell carcinoma occurring in Asia (~95%), Europe (~65%) and North America (35%).

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO^® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO^® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO^® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/ kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/ exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥ 2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY.

Clinical Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 227–previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 025–previously treated renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 238–adjuvant treatment of melanoma; Attraction-3–esophageal squamous cell carcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 649–previously untreated advanced or metastatic gastric or gastroesophageal junction or esophageal adenocarcinoma.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that the combination treatments not receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatments for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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In the latest trading session, Bristol Myers Squibb (BMY Quick QuoteBMY – Free Report) closed at $67.30, marking a -0.19% move from the previous day. This move was narrower than the S&P 500’s daily loss of 0.75%.

Heading into today, shares of the biopharmaceutical company had gained 0.99% over the past month, outpacing the Medical sector’s loss of 4.84% and lagging the S&P 500’s gain of 2.74% in that time.

BMY will be looking to display strength as it nears its next earnings release, which is expected to be July 28, 2021. In that report, analysts expect BMY to post earnings of $1.90 per share. This would mark year-over-year growth of 16.56%. Meanwhile, the Zacks Consensus Estimate for revenue is projecting net sales of $11.29 billion, up 11.49% from the year-ago period.

For the full year, our Zacks Consensus Estimates are projecting earnings of $7.46 per share and revenue of $45.92 billion, which would represent changes of +15.84% and +7.99%, respectively, from the prior year.

It is also important to note the recent changes to analyst estimates for BMY. These revisions help to show the ever-changing nature of near-term business trends. With this in mind, we can consider positive estimate revisions a sign of optimism about the company’s business outlook.

Research indicates that these estimate revisions are directly correlated with near-term share price momentum. Investors can capitalize on this by using the Zacks Rank. This model considers these estimate changes and provides a simple, actionable rating system.

Ranging from #1 (Strong Buy) to #5 (Strong Sell), the Zacks Rank system has a proven, outside-audited track record of outperformance, with #1 stocks returning an average of +25% annually since 1988. Within the past 30 days, our consensus EPS projection has moved 0.03% lower. BMY is currently sporting a Zacks Rank of #3 (Hold).

In terms of valuation, BMY is currently trading at a Forward P/E ratio of 9.04. This valuation marks a discount compared to its industry’s average Forward P/E of 24.76.

It is also worth noting that BMY currently has a PEG ratio of 1.3. This metric is used similarly to the famous P/E ratio, but the PEG ratio also takes into account the stock’s expected earnings growth rate. BMY’s industry had an average PEG ratio of 1.3 as of yesterday’s close.

The Medical – Biomedical and Genetics industry is part of the Medical sector. This industry currently has a Zacks Industry Rank of 204, which puts it in the bottom 20% of all 250+ industries.

The Zacks Industry Rank gauges the strength of our industry groups by measuring the average Zacks Rank of the individual stocks within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.

To follow BMY in the coming trading sessions, be sure to utilize Zacks.com.