Bristol-Myers Squibb Company (BMY) — Q3 2020 Earnings Call Transcript

Thanks, Kevin, and good morning everyone. Thanks for joining us this morning for our third quarter 2020 earnings call.

Thank you, Tim, and good morning, everyone. I hope that you and your families are safe and healthy. Q3 was a very strong quarter across the Company, adding to great performance over the past year. I will go into more details about the quarter in a few moments. But recognizing that it has been almost a year since we established our new Company, I would first like to give you my perspective on the Company overall. Turning to slide 4, a year ago, we transformed our Company with a goal of positioning us for growth in the near, medium and long term. I am very pleased with our ability to consistently deliver on that promise across multiple dimensions. Starting with integration where we continue to make great progress. The strength of our execution as a combined Company is a testament to our successful integration so far. The culture of our Company has been shaped by our values, including a focus on innovation, collaboration, and a great sense of urgency. Our synergy capture is ahead of our original expectations. From a commercial perspective, we have driven strong performance from our in-line brands. We have launched four new medicines including Inrebic, Reblozyl, Zeposia, and Onureg. We have entered the first-line lung cancer market with Opdivo and Yervoy.

Thank you, Giovanni. Hello, everyone. And thanks again for joining our call today. I’m very pleased by the execution of our teams, delivering very strong quarterly and year-to-date results while operating in this global pandemic. Let’s turn to slide nine and discuss our top line performance. Third quarter and year-to-date revenues continued to reflect our strong execution, growing 6% versus prior year on a pro forma basis. As you can see, a vast majority of our brands demonstrated robust growth.

Great. Thanks very much, David. Kevin, can we go to our first question, please?

Great. Thanks very much for the questions. And congrats on all the progress you’ve made this year. I guess, just two here, maybe first on TYK2. Could you just elaborate a little bit more on the safety profile? I think, there’s still some lingering questions out there of will we see any of maybe some of the JAK-like safety issues? I know you’ve talked a lot about that in the past. But just to confirm, did you see any imbalance at all, small or not, on thrombotic events from the study? And just help us a little bit in terms of what the profile is shaping up like, on the safety there? And then, my second question was on Opdivo. You’re launching a number of adjuvant indications next year. Could you just remind us on those, do you expect that these will have fast uptake, like we’re seeing in some of the metastatic settings, or are these indications that might take a little bit longer to build out over time? Thanks so much.

Chris, thank you. I think, I’ll start off and then Chris, I’ll pass on to you for the Opdivo-related question. From a TYK2 perspective, first of all, we are very happy with what we’ve seen from the result perspective. This is the first of the two Phase 3 trials for TYK1 that has read out. And we have seen not only statistical as well as clinical meaningfulness versus placebo, but also the superiority versus apremilast or Otezla in moderate to severe psoriasis. From what we have seen before from the Phase 2 studies, and we’ve talked about the safety profile, we continue to believe in that. There is a differentiated mechanism of action that we believe in. We do think that the TYK2 inhibition, which has a specific downstream effect on IL-12, IL-23 as well as interferon alpha has played out, and we continue to believe in that. Of course, I can’t go into the specifics of the data. They will be presented in the future in the medical meeting. But overall, we are very happy where we are. And I look forward to the readout of the second Phase 3 in the first quarter of 2021. So, hopefully, that answers your question. And let me pass it on to Chris to talk about Opdivo from here on.

Sure. Thanks for the question, Chris. We do have a number of exciting opportunities in the adjuvant setting. I’ll maybe just highlight gastric and bladder specifically. As we talked about a few months ago with respect to gastric cancer, we’re excited about the opportunity coming out of CheckMate -577. This is a space where there’s significant unmet need. There’s very little in the way of systemic therapy that’s used here. And as Samit has previously talked about, those patients who are getting neo-adjuvant chemotherapy and radiotherapy, about three quarters of those patients don’t achieve a pathologic complete response. So, really, there are no great options for those patients. And we’ve seen very good efficacy coming out of -577 with a doubling of disease-free survival at a manageable safety profile. And there is relatively clean air here from a competitive standpoint, as we’ll be the first immune-oncology drug in the setting for a number of years. With respect to bladder, again, we’re happy with the results that we saw with -274. This is a space with about 6,000 to 7,000 treated patients in the U.S. Again, not a lot in the way of great systemic therapies here. And as we’ve said, we met the primary endpoint for Opdivo and look forward to launching in the space. This is again another area where there’s relatively clean air. So, we would expect reasonably aggressive uptake in both of these indications.

Congratulations on the successful quarter and the progress made. Samit, I have a question regarding the 12-milligram dose for psoriatic arthritis that we are expecting to see data on next week. This is an area where we've seen challenges with other JAK inhibitors. Can you share what we should focus on when reviewing this data? It's about to be presented, and I believe it's something investors are keen to understand. Additionally, as we explore opportunities in conditions like ulcerative colitis, you’ve highlighted the IL-23 profile. Is this where your enthusiasm for the product really lies, particularly in ulcerative colitis? Thank you.

Thank you, Seamus, for your question. As noted in our press release regarding the POETYK1 readout, the dose utilized in the Phase 3 trial is the 6-milligram dose. The abstract and poster at the ACR for psoriatic arthritis include both the 6 and 12-milligram doses. From a safety perspective, the 6-milligram dose has shown a promising profile. Additionally, the older Phase 2 study indicated very positive results at that dose, which have been echoed in the Phase 3 study. The 12-milligram dose does show a dose response, but, as you pointed out, overall safety management is crucial. We will continue to analyze the data as we prepare for a Phase 3 study in the psoriatic arthritis area. Overall, we are pleased with the 6-milligram dose tested in the Phase 2 study, and we will reevaluate it in the Phase 3 second readout planned for the first quarter of next year. While efficacy is important, we must also consider the benefit-risk balance. Thus, the 6-milligram dose appears to be a reasonable choice from a combined safety and efficacy perspective. Regarding ulcerative colitis, as you mentioned, the differentiation lies in the convenience of oral administration. We’ve already addressed psoriatic arthritis, and we are looking forward to future readouts for the TYK2 program. It’s crucial to demonstrate both efficacy and safety for patients with ulcerative colitis with TYK2. Moreover, the IL-12 and IL-23 inhibition mechanism will significantly impact both ulcerative colitis and future efforts in Crohn’s disease.

Great. Thanks a lot, guys, for the questions. I just had a couple, I think both of them for Chris. So, when you look at the first-line lung trends for Opdivo, Chris, you guys have gained some share, I think 5% or so in the U.S. But, I don’t see much of a trend break this quarter. Was there already reasonable share in first-line lung before the label expansion? And maybe just help us to what’s been the feedback from the ground so far? And the second one on Reblozyl, the sequential trends have been really strong. I know obviously it’s early. But, what can you say about the distribution between MDS and beta-thal and maybe just the cadence of uptake between the two indications? Thanks a lot, guys.

Maybe I’ll start, and then I’ll turn it over to Nadim to address the second part of your question. So, with respect to Opdivo, let me just first give you the dynamics for the quarter. So, obviously, happy with the sequential growth that we saw for the quarter. That in the U.S. is a function of favorable demand, and I’ll talk about first-line lung, specifically in the second. We also, as David had noted, saw some inventory build. This was partially offset by the impact that we’ve seen with the decline in immuno-oncology eligibility that we’ve been discussing previously. That’s mainly in the second-line thoracic indications. And that still is a drag on Opdivo currently. That said, we’re happy to see that we’ve got sequential growth for the quarter. And that was in part a function of first-line lung. And with respect to first-line lung, we’re very happy with what we’re seeing with the launches so far in the U.S. The uptake continues to increase steadily. As we noted earlier, the market share is currently in the high single digits. The execution here continues to be very good. So, for example, we have a leading share in first-line lung. And importantly, at this stage of the launch, we’re seeing a nice steady growth in the number of new trials week-over-week. So, overall, we’re happy with the uptake that we’ve seen. We knew, as we discussed previously that this was going to be a different set of launches, just given the entrenched dynamics from a competitive standpoint in first-line lung. But, we continue to be very pleased with the team’s performance here. So, maybe I’ll turn it over to Nadim for the second part of your question.

Great. Thanks, Geoff, for your question. So, regarding the Reblozyl launch, maybe I’ll just make a couple of points. So, as David said, very pleased with the launch so far, high demand, very good brand awareness, field team is doing really well. And if you remember, we had always said that the predominant use, at least in the U.S., would be MDS, and it’s playing out exactly that same way. So, today, the majority use in the U.S. is on MDS patients. And the interesting thing is we’ve seen a little bit of a halo effect from beta-thal, but we’ve seen a little bit more uptake with beta-thal since the MDS launch. But, the predominant use is still MDS. Now, globally, as we launch across the world, there’ll be different regions where you see a different prevalence profile, beta thalassemia, where it’s higher, for example, in Asia, the Mediterranean. But today, in the U.S., Geoff, the predominant use is still MDS, exactly as we had anticipated. Thanks for your question.

Hi. Thanks for taking the questions. I was just wondering, first, on Opdivo for neo-adjuvant lung, if you can give us any update on the regulatory path and when you might know more there, and if you’re confident that you could get approval on the pathological complete response endpoint alone. And then, the second question, you mentioned that the synergies are tracking ahead of your expectations. I guess, just trying to understand how much of the spend is synergies and how much is kind of from a COVID environment? And so, how much of that should we expect to carry forward into 2021? Thank you.

Thank you, Terence, for the question, Samit here. As Chris mentioned earlier, there is still obviously a much required need for new medicines in patients with early disease to be able to get into a pathological complete response because that may signal for the long-term benefit for these patients. Now, of course, this is not a validated regulatory endpoint, as you very well said. So, what we are looking forward to now, of course, continuing our dialogue with the regulatory agencies, especially with the FDA, as we also continue to follow these patients for the first data for event-free survival as well. So, we will obviously keep you posted in the future as we make progress. At the current time, we continue our dialogue and continue with the patient follow-up to generate more data. I don’t think we can give clear guidance today in terms of approvability based on the endpoint. And for synergies, I think David or Giovanni?

Yes. David, why don’t you go ahead?

Yes. Terence, thanks for the question. Look, we’ve been very pleased with our ability to capture synergies so far this year. And we’re really encouraged to see that our synergy capture is actually tracking ahead of our original expectations for this year. So, we’ll provide further insight into that on our expectations of the overall synergy achievement after we close the year, but things are going very well.

I have a question on going back to TYK2. So, I think, most investors view the value proposition in psoriasis relative to Otezla being better efficacy. But, we’ve wondered if better tolerability could also be a differentiator, because with Otezla, there’s GI side effects that require dose titration, and your drug doesn’t require dose titration. And at least in Phase 2, there were no GI side effects. So, when we see the full Phase 3 results, might we also see better tolerability as yet another area of differentiation, beyond just oral dosing and beyond better efficacy?

Thank you, Tim, for the question. As we said, if you look at the overall trial design for this one as well as for the next study to be followed, the good news is that there is a comparison, not only versus placebo but also the comparison versus Otezla. And so, there will certainly be an opportunity to contrast and compare not only the efficacy, but all of the tolerability or safety as we talk about. And those are going to be very important from a patient perspective and physician perspective, from a convenience perspective. Certainly, these will have implications from a commercial perspective. And let me pass it on to Chris to comment on that.

Yes. Thanks for the question, Tim. I mean, I think, as we said previously, we’re excited about the opportunity that we have here, based on the data that we see coming out of POETYK. I think, we have a real opportunity to establish TYK as the frontline branded oral choice for these moderate to severe patients. What I would say, just to build on what Samit mentioned, is that this is a market where in spite of new biologics coming into the space, dermatologists continue to believe in an ascending treatment algorithm. So, they typically start with topical, they move to oral, then they go to injectables. And it is also a market, as I think you point out, where patient preference drives choice. So, you do see a very strong focus on safety concerns, needle phobia is an issue here. And we think these dynamics really play to the profile that we have with TYK2, very strong efficacy in an oral formulation, a novel mechanism of action, and a favorable tolerability and safety profile. And so, we think we’ve got a real opportunity here to establish TYK as the leading oral in the space.

Thank you. Couple of questions, please. First on Otezla. As you think about marketing, is it positioned to displace Otezla as the oral agent of choice, given the efficacy, tolerability, or to what extent can you actually seek to slow or defer the initiation of therapy with biologics? And then, second, perhaps you could just give us the market shares in non-small cell for 227, 9LA in the U.S. in the first-line setting.

Chris?

Sure, Andrew, thank you for your question. Regarding Otezla and the TYK opportunity in psoriasis, I would refer back to my earlier response. We believe that TYK has the potential to become the preferred oral treatment for moderate-to-severe patients in this area based on the data we have. This reflects the tendency of dermatologists to opt for less burdensome treatment methods while seeking maximum efficacy. Safety remains a significant concern, and we see a chance to replace existing oral therapies before biologics are considered. Additionally, we believe there is an opportunity to provide effective treatment options before patients advance to biologic therapies. It's important to note that only about 15% of patients eventually receive biologics, even with the introduction of new biologics in the market. Therefore, we see the potential to achieve both objectives. Regarding the first-line lung market share, as previously stated, we currently hold a market share in the high single digits. The 227 regimen is primarily used for patients with PD-L1 levels of 49%, and we are seeing increasing use of the 9LA regimen, mostly among patients with PD-L1 levels below 1 and those who are PD-L1 negative.

Hello. I wonder, now we have the ASH abstract, whether there’s anything you’d like to point out from the various data sets you’re presenting, and any particular update from durability of response? And then, ide-cel and liso-cel, any update you can give from the FDA review? Thank you.

Sure. Thank you. Let me start with ASH and then move on to liso-cel and ide-cel. If Nadim would like to add something, that would be great. From the ASH perspective, over the past few years, both Celgene and BMS have been present with data. Based on past presentations, these medicines have progressed to late-stage development, and we are continuing to gather more data. There are a few key abstracts being presented. Firstly, the activity of liso-cel as a single therapy and in combination, particularly for patients receiving ibrutinib and venetoclax in CLL, is quite significant. The overall response rate, tolerability, and durability in these patients continue to evolve, especially considering the future needs of patients with CLL who have been treated with ibrutinib and venetoclax, highlighting the necessity for subsequent therapies in case of recurrence or relapse. Another important data set is the triple combination of iberdomide with daratumumab and dexamethasone, alongside Velcade and dexamethasone. These represent advancements in the data, and we will monitor how it develops, but it is clear that response rates will be impacted as we aim to move iberdomide into earlier settings, guiding our future steps. We are pleased with the progress and will delve deeper into it, with plans to continue our focus on CELMoD’s trials for iberdomide and advancing other CELMoDs, as mentioned by Giovanni earlier. Regarding liso-cel, there’s not much new to share, but we continue our discussions with regulatory agencies. An inspection of the facility in Washington has been completed, and we previously communicated that there are no scheduled inspections for the second, independent facility. Liso-cel has a PDUFA date of November 16, and for ide-cel, we are also in ongoing discussions with a PDUFA date set for March 27, 2021. That covers our current status. Nadim, would you like to add anything or Giovanni?

No. I think you covered it well, Samit. Thanks.

The only thing I would add is, just to close on what Samit mentioned regarding liso-cel, we will update you as our discussions with the regulatory authorities progress.

Hi. Thank you for taking the questions. And congratulations on all the progress. Just some quick ones for me. When do you think you would be able to disclose the actual pathologic complete response rate for the 816 study? And if that would still be a nondisclosure item for you until regulatory discussions are complete? Could you at least give us how the study was powered on that endpoint, so we can make our own assumptions on how the chemo arm would perform and then how the combo arm probably would have performed, to start? And then, in terms of iberdomide, do you have a longer timeline now in terms of path to pivotal studies and when that could actually get to market? I think, a lot of us in the clinical community as well are thinking about this as an offset to Revlimid and the patent expirations there. So, any kind of longer term insight you might be able, given the development path would be super helpful. Thank you.

Thank you for the question. So, let me start with the pCR part. So certainly, we’re going to look for an opportunity for a proper presentation of the data at a future medical meeting. That is not dependent on the regulatory aspects because it’s an independent endpoint that can certainly be discussed. So, we’re looking to that. I think, the trial details, we have not shared the statistical analysis plan per se in terms of the assumptions made for the calculation at this time. So, we’ll not be able to share that. But certainly, there is a previous data that had been presented and published for chemotherapy leading to pCR responses. So, you can assume that. Now, what differences will be important in terms of a delta between chemotherapy and then the combination of nivolumab, those are the types of discussions we’ll need to continue to have with the regulatory agencies as to what becomes meaningful. So, as the dialogue evolves and once the decisions are made, we’ll certainly communicate that with you. From the iberdomide perspective, the first line plus study is already ongoing as we said. And as I’ve just mentioned previously, as the data continues to evolve and we’ll have the data readout sometime next year, those will be trigger points for us to discuss that single agent combination dexamethasone, discussions with the regulatory agencies to see if the data would suffice for a regulatory dialogue in the first line plus setting. And then has the data evolved for the doublets and the triplets in the earlier setting, then we’ll launch later line trials as well in the earlier settings. Nadim, do you want to add something to that?

Sure. I would just add a couple of points maybe. So, thanks, Dane, for your question. The point that Samit had made, our plan had always been to move from the doublet to the triplet, which is, as you know, very important, especially in relapsed and newly diagnosed disease. So, having these data at ASH will be an important foundation on how we move the treatment up from the late-line setting to early relapse setting and then ultimately, newly diagnosed setting since you had asked the question about Revlimid and the impact in the future. So, we have a very clear development plan. As Samit said, of course, we have to pass all the clinical gates as we go through. But, the starting point is the triplet data that we’re seeing at ASH now. So, we’re excited about the opportunity moving forward. Thanks for your question.

Yes. Thank you very much. So, I have two questions, please. First, could you provide more color on what you need to discuss with the FDA on liso-cel? It seemed to me that discussion should be over by this point. And a follow-on to that is, are there any issues with the recent manufacturing inspections, or do you have confidence following those manufacturing inspections? And then, the second question is, other BCMA ADCs have been associated with ocular toxicity in multiple myeloma. Do you expect a differentiated profile for your BCMA CC-99712? And, when should we expect to see data? Thank you.

Thank you for your question. Regarding liso-cel, as we previously mentioned, the FDA has communicated that both our facilities in Washington and Texas require inspection. Currently, they have inspected our plant in Bothell, Washington, but the inspection of the second plant has not yet been scheduled. The FDA is taking precautions to ensure the safety of their staff during the COVID pandemic, which impacts travel scheduling. We respect their plans regarding inspections. We've had positive discussions with the agencies and are hopeful for approval soon so we can provide treatment to patients. We will update you as soon as we receive a decision. While we will not comment specifically on inspection talks, we are pleased with the ongoing communication. On the ADC for multiple myeloma, we are in the early Phase 1 stage. It’s too early to determine if we will achieve a unique profile, but we are mindful of the ocular toxicity concern and will continue to assess patients for that. We anticipate the first data will be available late next year as we are still in the dose escalation phase. Once the data reaches maturity, we will present it at a medical conference and share it with you.

Giovanni, you’ve made it very clear that cardiovascular is a core franchise for the Company. On Factor XIa, what do you think you have to deliver in terms of clinical profile to enable that asset to add value in what will eventually be a generic environment? And then, maybe more strategically, in cardiovascular, it looks like you have at one end of the spectrum kind of a mass market Eliquis and Factor XIa approach, and on the other hand, a more specialized approach with MyoKardia. So, I assume your strategic vision in cardiovascular spans across that. But, curious if you want to be more focused in one end or the other as you consider additional business development in cardiovascular. And then, a follow-up for David. How would you describe the LOE step-down for Revlimid in the coming years? And do you think the Street has that right, at least in general in terms of how it’s being modeled? We obviously have imperfect information. Thank you.

Let me start by addressing your question about cardiovascular and Factor XIa. First, I want to emphasize that cardiovascular is strategically important to us, and this has been a consistent focus for the Company. I'm proud of our efforts with Eliquis and our ability to develop unique assets in this area. We take a distinct approach in demonstrating the value of these assets, as shown with Eliquis through real evidence, and maximizing the value of our medicines. Looking at Eliquis, mavacamten, and a Factor XIa inhibitor, we feel confident in our execution and commitment in cardiovascular. The approaches differ between broader assets like Eliquis and Factor XIa, where we chose to partner to enhance our reach into the primary care market and support the development of assets needing substantial investment across various indications. Mavacamten represents a more precision-focused effort in cardiovascular, aligning closely with our R&D strategy and our early pipeline in heart failure. It's not necessarily about one approach versus another; rather, it’s about recognizing cardiovascular as a field with significant unmet needs, where the Company has shown excellent execution capabilities. We tailor our approach based on what each asset requires for maximum value and where BMS excels. MyoKardia is an intriguing acquisition because its precision approach aligns well with our R&D strategy. Now, I’ll turn it over to Samit for any additional insights on Factor XIa, particularly regarding differentiation and our development strategy, and then we can address your question about Revlimid.

Thank you, Giovanni. The one thing that I would also add on mavacamten, remember, patients with obstructive hypertrophic cardiomyopathy, the ones that are symptomatic, the ones that we are talking about from a treatment perspective, also have arrhythmia, especially atrial fibrillation that they experienced. So, Eliquis is used there as well, and many cardiologists are very well aware of need of Eliquis. And certainly in the future when mavacamten potentially might be available, it would be very helpful for these patients. Coming back again then on to the anticoagulation and Factor XIa, I think certainly very happy that we are in that stage and with the Eliquis, what we have done. There are two things that are going to be important to remember is, number one, there are still bleeding risks and patients don’t necessarily get treated with true doses of currently available treatments, and some patients are not even treated because of the bleeding risk. The second unmet medical need is that patients cannot be treated on top of their background antiplatelet therapies for indications such as secondary strokes. And that is a very high unmet medical need, and patients who have had a first stroke are at very high risk of experiencing a second stroke, maybe even 50% to 60% probability. And therefore, what we’re looking for in the Factor XIa development program, as we look at the Phase 2 studies that are currently ongoing is number one, the decrease in the bleeding probabilities; and second, the combinability that background therapy of antiplatelet agents and the secondary stroke prevention study that is currently ongoing in terms of its enrollment. So, those are the important aspects that will make us go into the Phase 3 development program once the data are available. Let me pass it on to David to comment further on the Revlimid side.

We made great progress this year on the IP front, both with Revlimid as well as with Eliquis. And as you know, we settled with Dr. Reddy’s. We have the settlement with Natco, which just to remind you, remember, the Natco agreement is a single-digit volume entering 2022, which grows to about a third by 2025. And we have some other settlements, which aren’t public with Dr. Reddy’s and Alvogen. But, as we clearly see it more as a slope, not as a cliff, starting in 2022 with full generic entry coming in ‘26. And at the time we did the acquisition, all I’d say is that we took a more conservative view on Revlimid than the sell-side equity analysts did at that time. So with that said, we still believe Revlimid will add potential significant cash flow for the business over that period from ‘22 through ‘25.

Thank you, David. To address your question, during the period from 2022 to 2026, we expect Revlimid's performance to follow a gradual decline, starting from a strong position. Our confidence in the strength of our intellectual property has been reinforced by the outcomes we’ve experienced, including the IP that wasn't granted and the settlements mentioned by David. Furthermore, our business has continued to perform well beyond just revenue, and the advancements in our pipeline give us confidence in our ability to refresh our portfolio. As I stated earlier, I am optimistic about our capacity to maintain strong performance while we navigate the loss of Revlimid's exclusivity. This has been our goal from the beginning, and our execution so far has been effective, making me confident in our future success during this transition.

Thanks and congratulations on a solid quarter. I wanted to ask if, following the POETYK psoriatic study, you plan to explore moving this asset into a milder patient setting, similar to the recent advanced study. Additionally, I have a quick question regarding the Forbius acquisition. Could you compare and contrast the use of a TGF-beta monoclonal antibody combined with Opdivo versus a bispecific molecule like the one you track that is combined with the PD-L1 antibody?

Thank you for the questions, Matt. First of all, on the TYK2 aspect, so you know that we are very happy with the results from the POETYK1 study. You also know that there is a broad program already underway where we have the evaluation ongoing in psoriatic arthritis and lupus, systemic lupus erythematosus, lupus arthritis as well as the inflammatory bowel disease. Mild psoriasis, we certainly have an eye on it. We obviously think about this as we evolve with the data on psoriasis, we have to look at the overall efficacy and safety profile in the second study also readout. And that will dictate where we go next in terms of evaluation of deucravacitinib in psoriasis and other indications related to psoriasis. On the TGF-beta front, we are of course, aware of the bispecific TGF-beta PD-1 that the competitors have. When we look at TGF-beta, the specificity of the inhibition caused by this particular entity is very important. And we certainly will look at the combination with our own pipeline, not only with nivolumab, but we also have relatlimab, as you know, in development. So, we’ll be looking at all those combinations as the Phase 1 study did evolve, and we get to see what the dose and the schedule will be for dosing patients with oncologic indications, and that will pave the way for the combination strategies looking forward. I think having the ability to give two drugs separately will give us more opportunities for combination strategies looking forward.

Great. Good morning, guys. Thanks for taking the question. Congrats on the quarter. I guess, first, a competitor in the TIGIT space that is perceived to be most closely related to you with also an Fc mutated region, discontinued their program recently. In the past, you’ve been relatively sort of balanced language on the outlook for this program. Any change or updates on how you see there? Any commentary on that discontinuation or differentiation that maybe the Street doesn’t appreciate between those two programs? And then, maybe coming back to the CELMoDs again. Should we think about the iberdomide decision sort of running independent for 92480, or is there going to be a decision to be made at some point next year where you need to sort of pick a winner or can they coexist? Thank you.

Sure. Thank you, Carter. I think, great questions. First of all on the TIGIT side, we certainly have seen the announcement from the competitor from discontinuation of the program on the side. And we don’t know the details and the structure of their molecule, etc. But certainly, we have our own molecule, which is in Phase 1 study. We also have been looking at to see where we go with the combination very early on to be able to define the path forward. As the data evolves, we’ll certainly update you and others in terms of where we go or what the fate of the program will be. But, it is too early to say from our own perspective, the specificity of inert Fc portion or inactive Fc portion, I think needs to be further investigated before a decisive decision can be made on that side. So, more to follow on TIGIT in the future. On the CELMoDs and iberdomide side, as we said, both of our programs are in development. Iberdomide is a little bit further because it started earlier. 480 is a very potent molecule. We shared the data of 50-plus-percent of overall response rate with 480 plus dexamethasone in the line setting. Both of those studies are in the development setting. But if you recall, the overall development of IMiD in the past, Revlimid and pomalidomide, how they were developed in the organization, how Revlimid then set up in the upfront setting and pomalidomide then became a preferred molecule for the second, third-line patient population. So, we have to keep that in mind as we continue to evolve. And we also have the good position that we have a lot of data available from a multiple myeloma perspective that we can actually investigate to see what is the mechanism where these drugs will fit the best, what opportunities we may be able to avail in terms of combination strategies with our own pipeline, looking at the platforms that we already have, not only with CELMoDs, but also from the T-cell engager, from CAR-T cell therapy as well as the evolving ADC platform. So, those opportunities, because of the few CELMoDs we have in our hand can certainly be further investigated in a broader way, rather than limiting ourselves to a singular CELMoD. But let me ask Nadim to add anything he wants to further elaborate on this. Thank you.

Sure. Thanks, Samit, and thanks, Carter, for your question. So, I think, right now, we’re very pleased with the early data we’re seeing for both. And as Samit said, we’ve done the same with Revlimid and Pomalyst in the past. So, there are discrete patient segments with very different clinical needs where you could potentially see the coexistence of both CELMoDs. So, for example, the maintenance setting, a CELMoD with a better tolerability profile. In relapsed setting with high-risk disease, you could see a more potent CELMoD come through. So, I think we’re going to continue to look at the data but we’re pleased with how both are progressing. And then, as Samit said, one of our key objectives is to come up with this multi-modality combination approach. So, you can envisage a CELMoD plus BCMA through multiple lines of therapy as patients progress from newly diagnosed disease to late-stage disease. And we’ve already seen the use of sequential treatment through the current CELMoDs, or I should say, with Revlimid and Pomalyst. So, we do think that the combination of BCMA and CELMoDs across lines of therapy, a different patient segment could be really important, both clinically and commercially. So, thanks for your question.

Thank you. Thank you, Nadim. And thanks to all of you for joining our call today. We have a lot to discuss, and I think that speaks to breadth and depth of our business, and importantly, our pipeline. So, as we discussed, it’s been a really active year and a very, very exciting first year for a new company. And I can say with confidence that Bristol Myers Squibb today is in a really strong position with significant near-term launch opportunities and a substantial pipeline to address unmet needs of patients that will position us very strongly and very well for the future. So, thanks again for joining us. And as always, our team will be able to answer further questions you may have. Have a good day. Thanks, everyone.