January 22, 2022

The World Stock Markets Tips & Targets, News, Views & Updates

The World Stock Markets Tips & Targets, News, Views & Updates

Bristol-Myers Squibb Company (BMY) CEO Giovanni Caforio Presents at JPMorgan 40th Annual Healthcare Brokers Conference (Transcript)

Bristol-Myers Squibb Company (NYSE:BMY) JPMorgan 40th Annual Healthcare Conference January 10, 2022 7:30 AM ET

Company Participants

Giovanni Caforio – Chairman & CEO

Conference Call Participants

Chris Schott – JPMorgan

Chris Schott

Good morning, everybody. I’m Chris Schott at JPMorgan, and it’s my pleasure to be introducing Bristol-Myers to again kick off the JPMorgan Healthcare Conference this year. From the company, we have Giovanni Caforio, our Chairman and CEO.

And before I turn it over to Giovanni, I just want to remind people that if you want to ask a question, feel free to use the ask a question feature on the website. We’ll work those into the Q&A post the presentation. With that, Giovanni, Happy New Year, and thanks again for joining us. Looking forward to the presentation today.

Giovanni Caforio

Thank you, Chris. Thank you. And good morning, everyone. It’s great to be with all of you this morning.

On Slide two, you can see our legal disclosures. But let me start right away on Slide three. Bristol-Myers Squibb today is a company well positioned to drive growth through the decade. And we have multiple growth drivers and a real proven track record of execution. Importantly, our growth will more than offset the loss of exclusivity impact that we have ahead.

So it’s an important day today. Here is what I plan to cover with you this morning. First, I’m going to share with you our growth outlook for the decade ahead and clearly describe our long-term expectations. Then I’m going to outline the powerful growth drivers that underpin this outlook. And finally, we will focus on execution, what we have delivered and what specifically you can expect from us in the 2 to 3 years ahead.

So let’s turn to Slide four now, which shows the strategic foundation on which the company is built. This is a consistent innovation strategy that we’ve been executing against for almost 15 years.

It’s focused on blending the agility of biotech with a financial, commercial and global strength of traditional pharma. This strategy has really served us well, and we’ve adapted our execution to enable us to stay firmly ahead of the innovation curve for the future.

On Slide five, you can see that the execution of our strategy indeed has been a journey of transformation for BMS. In 2007, we introduced our BioPharma Strategy, leveraging our strength in R&D to focus exclusively on innovative biopharmaceuticals.

Over time, we evolved our focus to Specialty Medicines, given the exciting opportunity that we saw emerging from our pipeline, including, as you know, our pioneering work in immuno-oncology. And now we are renewing our portfolio for the long term, with a much broader innovation engine and a powerful portfolio of new product launches, which we are executing.

So moving to Slide six. What does this all mean in terms of our growth profile? Here, you can see the key [ph] drivers that will enable us to drive growth through the decade, and they are divided into two time periods. So let me walk you through the components.

Firstly, let’s look at the outlook through 2025 on the left hand side. I want to reiterate my confidence in our ability to grow through the Revlimid LOE, and this is driven by the exciting opportunity that we have to transform and strengthen our company with what we’re calling our continuing business.

And we expect this portfolio of in-line growth drivers and new products will enable us to more than offset the impact of LOEs, grow our top line through 2025 and remain very profitable with operating margins in the low to mid-40s.

Now secondly, looking to the post Revlimid period on the right hand side. As I told you in November, I expect 29 ph sales to be higher than 2025. We will continue to execute commercially and advance our pipeline, and we see multiple pathways to growth during this time frame.

Of course, on top of what we already have in-house today, our financial strength provides additional growth optionality through capacity for continued disciplined business development.

Now let’s turn to Slide seven and to the drivers that underpin our growth expectations. And on the next slide, you can see why I’m excited for our future. We are in a fortunate position of having four pillars of long-term growth, as you can see here. And in fact, each pillar has and contains its own deep subset of growth drivers. These span our new product portfolio, our mid to late-stage pipeline, a robust early pipeline and the strategic flexibility that derives from our financial strength

So I will walk you through each one of these today, but I want to start first with a foundational growth opportunity from our in-line brands, particularly I-O and Eliquis.

So moving to Slide nine. I remain really excited about the $8 billion to $10 billion growth opportunity from these brands in the 2020, 2025 time frame, and let me tell you why. These are standard-of-care medicines today. Our I-O products have the opportunity to expand into additional indications, particularly in the adjuvant setting, and Eliquis is the leading agent in a growing class as warfarin usage continues to decline around the world.

Beyond the direct revenue growth that these products can deliver, these are flagship franchises built on industry-leading commercial capabilities, which we can leverage for future product launches. Let me now focus on our first long-term growth pillar, our new product portfolio, which we expect to drive significant revenue expansion.

On Slide 11, you’ll see we expect this portfolio to deliver $10 billion to $13 billion of risk adjusted revenue in 2025. These are all first-in-class and best-in-class medicines. 6 of these 9 products are already launched with 3 remaining, 3 proxy products expected to be approved this year. And there are many important expansion opportunities ahead for each one of them.

Moving to Slide 12. You can see that 2025 is just the beginning for these products. We see significant further growth driven by continued commercial growth and new indications with this product portfolio having over $25 billion of potential in 2029.

This portfolio is comprised of multiple products with significant revenue replacement potential, which will therefore diversify our revenue mix. It includes two assets with at least $3 billion in expected non-risk adjusted revenue and four assets with at least $4 billion expected non-risk adjusted sales. So let’s take a deeper look at the four assets with $4 billion plus potential.

Starting with Reblozyl on Slide 13. We believe Reblozyl is an exciting and differentiated medicine for the treatment of anemias. We continue to see an opportunity to expand in our current indications of beta fall [ph] and second-line RS-positive MDS.

Additionally, we also see a significant expansion opportunity ahead from the COMMANDS trial, which we expect to read out next year. And we have an opportunity to further expand in myelofibrosis.

Now turning to Mavacamten on Slide 14. Remember, this has the potential to be a first-in-class medicine to treat the underlying cause of obstructive HCM. We see a large undiagnosed population, which we expect will expand over time. And as the first-to-market drug with no differentiated competitor on the horizon, we expect to be able to drive significant penetration in this population.

And we look to expand to adjacent indications, such as non-obstructive HCM and heart failure with preserved ejection fraction over time. We’re ready to launch, and we are looking forward to the PDUFA in April.

Now moving to Deucravacitinib on Slide 15. This is our selective TYK2, and we believe it has the opportunity to be a medicine that could treat multiple immune-mediated diseases.

We’ve now filed this drug in psoriasis with a PDUFA in September, and its oral of choice profile continues to be confirmed in additional studies from Japan and with longer follow up. Now building beyond psoriasis, we’re exploring expansion opportunities with studies in psoriatic arthritis, IBD and lupus.

And turning to another opportunity with Relatlimab on Slide 16. This is our first-in-class LAG-3 inhibitor in a fixed dose combination with Opdivo. Today, we are planning for our launch in March in first-line melanoma with multiple expansion opportunities in adjuvant melanoma, lung, liver and CRC.

This means that as the leading innovator in I-O, we are the only company with not just two, but potentially now three I-O agents in our portfolio. And as a fixed-dose combination, this asset obviously has the potential to extend the durability of our I-O franchise well into the next decade.

Now let’s turn to our second long-term growth pillar on Slide 17, the exciting potential of our mid to late-stage pipeline. And to put our pipeline into context, on Slide 18, I’d like to point out that we have expertise and pipeline depth across four therapeutic areas that each have significant commercial potential.

We currently have seven mid to late-stage pipeline assets targeting these areas. And let me tell you about a few in particular. Milvexian, our multiple myeloma CELMoD Agents and our Folate Receptor, ADC.

So starting with Milvexian on Slide 19. We see this product as having a $5 billion-plus non-risk adjusted revenue opportunity as a next-generation anti-thrombotic. As you know, in November, we and our partner, Janssen, presented exciting data for this drug and the profile looks differentiated from what you would expect to see from existing anticoagulants like Factor Xa drugs. This potentially enables us to treat more patients with a better option.

We’re now looking forward to seeing the data from our second Phase II in the first half of this year. And assuming it is supportive, there are a wide range of potential indications under consideration for Phase III, including those where Factor Xa’s are used today and others, where patients do not widely benefit from anticoagulation.

And turning to another exciting opportunity in our pipeline on Slide 20. With our multiple myeloma CELMoDs that have the potential to replace the current IMiD backbone. We have a long legacy of successfully advancing the science and treatment of myeloma, starting from our IMiDs, thalidomide Revlimid and Pomalyst. And at ASH last month, we presented very encouraging data for iberdomide and ‘480, our new CELMoD agents, which are now, as you know, more potent degraders of cereblon in highly refractory patients. This data gives us confidence to move forward with registrational trials so that these agents can potentially replace Revlimid and Pomalyst over time.

And now turning to another important asset, MORAb-202 on Slide 21. This is a Novel Folate Receptor Alpha ADC, which we have partnered with Eisai. It’s a differentiated ADC from others due to its payload and potential to expand the patient population to include low folate expressors. Early data demonstrated clinical activity across multiple tumor types in heavily pre-treated patients with the potential for registrational trials to start this year.

Turning to our next slide. In addition to a powerful continuing business portfolio and a high potential mid to late-stage pipeline, we have a deep and exciting early-stage pipeline, which is our third pillar.

And you can see our early pipeline here on Slide 23. Over the recent years, we have significantly strengthened our innovation engine, both deepening and expanding the breadth of our early pipeline. So there are now more than 50 assets in clinical development, and we expect more than 20 assets to undergo proof-of-concept decisions in the next 3 years.

As you can see, this pipeline is built on a foundation of four leading platforms across small molecule chemistry, biotherapeutics, protein homeostasis and cell therapy. This pipeline will help support the sustained innovation that we will deliver in the future.

In addition, on Slide 24, you can see that we’ve built an extensive network of external partnerships that amplify our internal R&D strengths. In fact, we have over 85 active collaborations. This ensures were fully connected to the innovation ecosystem across biotech and academia.

Now let’s turn to our fourth long-term growth pillar, to our financial strength and the strategic flexibility it provides us with. Turning to Slide 26. Over the next 3 years alone, we expect to generate $45 billion to $50 billion in free cash flow. This enables us to maintain a consistent, balanced approach to capital allocation. We are focused on investing for future growth through business development, while strengthening the balance sheet and returning cash to shareholders.

As you know, last month, we announced a $15 billion share repurchase authorization, which gives us the flexibility to buy back shares over time. In that context, today, we announced a plan to execute a $5 billion ASR agreement during the first quarter of this year. At the same time, our financial flexibility enables us to accomplish this while continuing to prioritize business development.

And in terms of business development, let me remind you on Slide 27 that we continue to view sourcing innovation to support our growth profile as our top priority for capital.

As you can see here, we have been active in business development and have executed multiple deals over the past 18 months, including an early stage cell therapy deal with CENTURY Therapeutics announced this morning. We remain focused on sourcing innovation in our key therapeutic areas of strength. And while size-agnostic, we are interested, particularly in small-scale early science deals and mid-sized bolt-on deals.

Now turning to the next slide. Given that our growth plans depend on replacing a significant portion of our revenues in the decade ahead, the question obviously arises how confident can investors be in our ability to execute on this plan. Well, let me tell you that I’m really proud of our execution record.

Let’s look at ’21 on Slide 29. You can see the milestones I laid out for you at this conference last year that we believe would be important for us to deliver during 2021. Well, as you can see, we have clearly delivered. I am very proud of the employees of Bristol-Myers Squibb and what they’ve accomplished.

Let me give you some highlights. We have returned Opdivo to growth. We have delivered successful data for a third I-O drug with Relatlimab. We have launched multiple new products and key indications, including our cell therapy treatments, Abecma, [ph] Breyanzi and the ulcerative colitis indication for Zeposia. We have delivered exciting data for Deucravacitinib and filed it with the FDA. We produced key expansion data sets for several products.

This score card demonstrates what I mentioned earlier. BMS is an organization with highly effective execution capabilities. This further strengthens my confidence in our ability to deliver on our future plans and meet our commitments. Of course, that was last year.

So let’s look to the future on Slide 30. The depth of our portfolio provides multiple near term catalysts for the company. There is a lot here, which is really exciting, and we will ensure to keep you updated on our progress this year just as we did in 2021. At the same time, there are a number of critical milestones that I’m particularly focused on over the next year or 2.

So on Slide 31, here are five of the most important milestones ahead, including the expected approval of three new products, the expansion of Reblozyl into a broader indication, the establishment of a leading cell therapy franchise and broadening access for Zeposia in ulcerative colitis. We are very focused on meeting these milestones and look forward to updating you as we move forward.

Now turning to Slide 32. So what does this all mean for us financially in 2022 as we continue to execute on our plan? 2022 will be another important step in our growth journey. We see 2022 top line growth from our continuing business more than offsetting the impact of LOEs, and we expect to continue to deliver non-GAAP EPS growth.

Let me provide some details around our revenue growth expectations this year, given the upcoming generic competition for Revlimid. Within the LOE category, the key impact this year is due to Revlimid. As we have told you, we expect full generic entry in Europe this quarter, in Japan mid-year and with volume limited entry starting in the US beginning in March. We expect Revlimid sales globally to be between $9.5 billion and $10 billion.

Looking beyond this year through 2025, although there is still uncertainty due to ongoing litigation, we view an annual step down of roughly $2 billion to $2.5 billion per year as a reasonable projection. At the same time, as we’ve told you before, we are very encouraged by the growth potential in our continuing business.

This year, we expect our continuing business to grow double-digit, low double digits and contribute approximately $36.5 billion due to significant growth from I-O, Eliquis and the new product portfolio. And this is just the beginning as we expect significant growth from our continuing business in future years, as I’ve described already. Beyond revenue growth, based on the strength of the business moving forward, you can see that we are also guiding to continued non-GAAP EPS growth this year.

In summary, on Slide 33, I’ve shared with you my view that Bristol-Myers Squibb is a growth company. We have all the building blocks in place to deliver growth through the decade. A strong continuing business of in-line brands and new products that will drive low to mid single digit growth through 2025, nine new product launches, including 4 with $4 billion-plus non-risk adjusted sales potential, a rapidly advancing pipeline, and the financial strength for continued business development, all of which will ensure growth beyond 2025 and importantly, an execution record second to none. Thank you. And Chris, I look forward to your questions. Thanks.

Question-and-Answer Session


Q – Chris Schott

Great, Giovanni. I appreciate those comments. Maybe to kick off, I would love to talk a bit about the 2022 guidance. I know some of these details might have to wait until February.

But first, can you talk about the low double-digit core growth that you’re thinking about? How much of that are products like Opdivo and Eliquis versus how much of that is this new pipeline contributing to growth in ’22, which I don’t know, qualitatively what you can provide there?

Giovanni Caforio

Yeah. Thank you, Chris. Of course, we’ll provide more detail as we go into providing full guidance at the next earnings call. But let me just say that our continuing business is in really good shape. There is good momentum in the business. And the low double-digit growth is a combination of – of the 2 very, you know, very, very good trends with Eliquis and Opdivo and building momentum for the launch portfolio. Remember that at the Q3 earnings call, the new product portfolio was annualizing sales of about $1.5 billion. Those brands are continuing to grow.

As you look at the 2020 to 2025 period though, it’s clear that we see the growth of new products accelerating over time, and that’s because of the momentum that builds with the launches and the opportunity to expand some of the labels to broader opportunities, as I mentioned, for Reblozyl as an example. So I would say growth coming from both. And over time, the new product portfolio becoming more and more important.

Chris Schott

Okay, great. And I really appreciate the comments on Revlimid. I know that’s been a big topic of conversation with investors. But when I think about the $9.5 billion to $10 billion target in ’22, should we think about that erosion mostly coming from Europe and Japan to the ex US business? Or is it more evenly balanced between US and Europe?

Giovanni Caforio

Well, so it’s coming from both. Obviously, as you look at the US and Japan – sorry, Europe and Japan, Europe in Q2, Japan in the middle of the year, those are more traditional and rapid erosion curves, whereas in the US, it’s a volume limited entry beginning in March.

But there is a bigger impact from international markets this year, which I know is one of the elements that we’ve been discussing with investors and then obviously the erosion in the US over time.

And that’s the reason why we’ve provided a perspective not only on this year’s revenues for Revlimid but also the step down magnitude that one should expect over the course over the next few years.

Chris Schott

Yeah. Hopefully, it puts that topic to bed a little bit because I know that’s been one that we continue to get. And the final one I just would have on ’22, you’re now seeing a $5 billion ASR today. Should we think about these earnings numbers reflecting that? Or is that something that could be incremental to the earnings line?

Giovanni Caforio

We’ve included the impact of the ASR in the earnings number. The earnings would grow regardless, but the numbers we provided in terms of guidance for non-GAAP EPS includes the impact of the ASR.

Chris Schott

Okay, great. Then maybe pivoting to longer term guidance. I guess when you look at the targets, it seems like between now and 2025, the targets are more in line with what the Street has been. But I think about ’25 and beyond, your targets are well above where we are.

When you guys look at your internal projections versus where the Street is, what are the biggest outliers you’d highlight in terms of, I guess, this gap between Street expectations and your own?

Giovanni Caforio

Yeah. Thank you, Chris. I think it’s really all about the most important contributors from the launch portfolio. And as we have an opportunity to launch mavacamten and deucravacitinib or relatlimab and advance our product portfolio, the profile of those medicines will become clearer execution, commercial in the marketplace we’re confident will demonstrate the very attractive profile that these medicines have.

So when we look at our projections, which are informed, as you can imagine, by what we are hearing from physicians, our understanding of the profile of those medicines and the opportunity that is in those diseases, we’re really confident in our forecast. We see relatlimab as being an extremely important asset. Of course, it starts in melanoma, but there are multiple potential expansion opportunities.

We’re really excited about mavacamten because it is the first agent to be able to treat the course of an important disease. And we look at that disease as one where diagnosis rates and treatment rates will increase over time.

We look at Reblozyl and the opportunity to more than double the size of the addressable patient populations when we see the results of the COMMANDS trial and eventually move into myelofibrosis. And similarly for deucravacitinib, we see that, that medicine as having the profile that enables us to think about the oral of choice in psoriasis. So it’s the most important assets in our late stage and launch portfolio, I’m sorry, which are – where we see a disconnect.

Chris Schott

Yeah. And just on that topic, I think you talked about this $25 billion non-risk adjusted sales view, I guess how much is derisked in your view as we think about risk adjustments versus non [ph] I guess one of the questions we get is you know, how much line of sight do you feel you have to that $25 billion now versus clinical studies that might be riskier, et cetera. So just I don’t know what perspective you can provide on that.

Giovanni Caforio

Yeah, I think I would provide two types of perspectives. So first of all, we’ve been very clear that we see multiple paths to continued growth between ’25 and ’29. And I want to be clear that when I say I’m seeing ’29 sales higher than revenue higher than ’25, it’s not if all of the events derisk and everything works. There are multiple scenarios that enable us to grow the company between ’25 and ’29, which is really one of the elements that drives our confidence.

The second thing that I would say is that many of the important derisking events will happen in the next 12 to 18 months. Again, an example is the COMMANDS trial for Reblozyl and the approvals for mavacamten and deucravacitinib. And so by the time we get to the end of ’23, the ’23 to ’24 period, I would say, the vast majority of the key drivers, we will have seen data sets for.

Chris Schott

Okay. That’s helpful. Just pivoting to capital deployment. You’re now saying this $5 billion ASR this morning. Just maybe bigger picture, how do you think about balancing repo versus business development as you think about the cash flow you’re generating over these next few years?

Giovanni Caforio

Well, first of all, I’ve been very clear that I see business development as the number one priority for capital deployment. And as you look at the deals that we’ve done over the last 12 to 18 months, they’re very representative of the types of deals we want to do.

There is a relatively large number of early science deals like the one we announced today with CENTURY, where we’re going to strengthen the long-term outlook of our cell therapy – leading cell therapy platform. At the same time, the acquisition of MyoKardia provides a good example of bolt-ons that are – that fit into strategic areas that we know well where we can maximize the value of assets. So we’ll continue to prioritize business development.

At the same time, our business is very strong. We have tremendous financial flexibility. We expect to generate $45 billion to $50 billion in free cash flow between ’22 and ’24, and that provides us with an opportunity to continue to prioritize the dividend.

As you know, at the end of last year for the 13th consecutive time, we increased it by approximately 10% and opportunistically announced share repurchase activities like the one we’ve announced this morning for $5 billion for an ASR. So it’s a balanced strategy, but BD remains the key pillar [ph].

Chris Schott

Okay. And then I just think about BD being a focus, as we get, I guess, closer to the LOE cycle, should we think about there being more of a focus on maybe near to market or end market assets as you look to manage through that period?

Or will we think about this kind of continued balance of anything ranging from early stage all the way through later transactions?

Giovanni Caforio

I would say it starts from the fact that we have a really strong internal pipeline. And today, of course, we’ve covered a lot the launch products. But when you look at Milvexian, when you look at the CELMoD programs, there are multiple mid to late stage assets that will continue to grow – enable the company to grow over the mid and the long term.

And so I see that we’ll continue to be balanced, as I just described in business development. It depends on our ability to bring into the company assets that we think we can maximize in areas we know well in a way that generates value for shareholders. But I continue to see that as being balanced.

Chris Schott

Okay, great. Maybe pivoting to some of the pipeline assets, I guess with the $4 billion peak sales kind of growth driver is I find that to feel like they’re particularly controversial to the Street right now. So I guess maybe the first of these is mavacamten.

So maybe the questions here, first, you talked about, I think, the REMS being maybe related to the PDUFA extension. How do you think about a REMS and the impact that could have to the uptake in commercial potential of the drug?

Giovanni Caforio

So Chris, first of all, we’ve known about the REMS from – since the time in which we conducted diligence on the acquisition of MyoKardia, and we’re not concerned about that. We specifically have significant experience with REMS, possibly one of the companies that has the most experience. And so we know how to execute our REMS program well.

We understand it is more common in some therapeutic areas than others. But – and there are more examples in oncology in our own experience as an example. At the same time, we don’t see that as a barrier to adoption. We feel that physicians will want to follow patients at the beginning as they begin to look for the right dose for every patient and initiate therapy. And so they will use echocardiography and other types of tools that belong to clinical practice.

Remember also that in our REMS, there is a really important educational component, which actually, I believe, can be helpful to physicians as they really think about where they place a new medicine into their treatment strategy. So we’re really focused on the REMS. We’re going to be executing that well as a priority, but we don’t see that as a big barrier to adoption.

Chris Schott

Very helpful. And then the last one for me on mavacamten, just the $4 billion target, what does that imply in terms of competitive landscape? And how are you thinking about competitors out there?

Giovanni Caforio

So first of all, we really don’t have a differentiated competitor on the near term horizon. And given the strength of our data and the potential to launch in April, we have a relatively sort of long period of time during which we have an opportunity to establish mavacamten as the leading agent in the space.

As we look at the long term, we always assume that there may be competition from other agents. But at this point, particularly in HCM, we don’t see differentiated competitors on the near term horizon.

Chris Schott

Okay, great. Going to other kind of big opportunity as a lot of questions is, I guess, around TYK2. So I guess, at the heart of it, I guess, just you’ve been very clear, I think you been [ph] something different than a JAK. To the extent, though, that we get a JAK label, I guess, what does that mean for the product? Because it feels like on one hand, you’ve got the data out there. It looks really clean and the physician feedback seems positive.

So can you just help put some context around – is the Street [ph] overly focused on that specific label language you know, in that scenario where you get a black box or just help us, I guess, a little bit of your views in that, I guess, downside case that you were to get a class label for the product.

Giovanni Caforio

Yeah. No, thank you, Chris. So first of all, it’s true that when we speak to physicians that know the data well, thought leaders in the field, they’re not concerned about deucravacitinib being a JAK because it isn’t. And they look at the profile and the profile makes them comfortable that they’re seeing a safety profile that is very consistent with the mechanism of action and very different from a JAK.

As we look at preparing for launch, of course, we always look at multiple scenarios and different types of labels. And it’s difficult for me to speculate on what the FDA decision will be. We feel we have a very strong case. But obviously, we’re in the middle of a review.

I don’t think there is – I don’t think there are only two binary events. I think there are multiple scenarios that can play out in terms of how the safety is described in any product’s label. And we are very focused on articulating the case as to why this is a IL-12/23 inhibitor and not a JAK, and we’re very confident in the strength of our argument.

Chris Schott

That makes sense. Just one last one for me on the pipeline. The Factor Xa seems like a lot of enthusiasm from the data we saw in the fall. Maybe just a two part question here. What are you watching as we think about the secondary stroke kind of readout and how that informs clinical work?

And I guess a bigger picture question we just get is should we think about this as a drug that’s kind of going head-to-head against the Xa’s? Or is the opportunity here to move more into markets where historically the Xa’s weren’t used?

Giovanni Caforio

Yeah. We are looking at a longer term treatment in the second Phase II study, and we’re looking at combination to continue to define the efficacy safety profile of the molecule, finalize a choice on the dose and move forward with the Phase III program. So it’s really the combination of the studies that informs the Phase III program.

I think there is an opportunity in both areas. Depending on the profile, there is an opportunity to further strengthen the therapeutic value in areas where Xa’s are used today. At the same time, we’ve been very clear from the beginning that the combinability with antiaggregants makes it possible for us to think about going into a number of indications where Xa’s haven’t been able to go because of the risk of bleeding.

So that’s really the reason for the excitement behind milvexian that we have. It’s because it’s a broader approach that we’ve been able to think about with Eliquis.

Chris Schott

Great. Just a policy question. I guess it’s been – something about building back better and obviously kind of a lot of iterations of where this ultimately goes. What do you see that program, if it were to move forward, meaning for kind of Bristol and the broader industry?

Giovanni Caforio

Yeah. So first of all, it’s very fluid, as you know, and at this point. First of all, I’ve always been very clear that I think reform is needed and we are not for the status quo. So when you look at what we know about build back better, there are some elements of that proposal which actually would be very helpful to patients, the redesign of Part D [ph] the establishment of an out-of-pocket cap, the spreading of the cost for the patient over the year.

These are all things that would be extremely beneficial to patients and obviously would enable better adherence and patients to stay on treatment as long as they need to, which is a real issue right now. There are elements which we disagree with, which is price controls by the government, and I’ve been very clear about that as well.

In terms of what it means for BMS, a lot of the focus and many of the questions that I have received are really above the three large medicines we have. So as I think about the proposal where it stood at the end of last year, you think about Revlimid, it will be a very small medicine by 2025.

When we look about – when we think about Eliquis there are really pluses and minuses for Eliquis because on one side, obviously, the redesign of the Part D program is beneficial. But on the other side, by 2025, ’26, if, in fact, there were price setting by the government, Eliquis will probably be impacted. So there are pluses or minuses there. And then for Opdivo, it’s closer to the LOE towards the second half of the decade.

So I would say the advantage of having – going forward a much more diversified portfolio of medicines across different parts of Medicare and commercial markets, many more medicines launching is that going forward, BMS is clearly even better positioned, in fact, to navigate reform than we’ve ever been in the past. But as you said at the beginning, we need to look at the details as they advance.

Chris Schott

Makes sense. Well, I think we’re just out of time here. Giovanni, really appreciate all the comments today and best of luck with you. Seems like a lot going out of the company, pretty exciting times. But thanks again for joining us.

Giovanni Caforio

Thanks for having us, Chris. Thanks. Have a good conference. Thank you very much.

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