Q1 2023 Bristol Myers Squibb Co Earnings Call
Yes.
Good day and welcome to the Bristol Myers Squibb first quarter 2023 earnings call.
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Thanks, Kevin and good morning, everyone. Thanks for joining us this morning for our first quarter 2023 earnings call joining.
Joining me this morning with prepared remarks are Giovanni <unk>, Our board Chair and Chief Executive Officer, and David Elkins, Our Chief Financial Officer.
Also participating in today's call are Chris burner, our chief operating officer and someone here about our Chief Medical Officer, and head of global drug development.
As you'll note, we posted slides to BMS dot com that you can follow along with for Giovanni and David's remarks.
Before we get going I'll read our forward looking statements. During this call we will make statements about the company's future plans and prospects that constitute forward looking statements actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the Companys SEC filings.
Forward looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date, we specifically disclaim any obligation to update forward looking statements. Even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items reconciliations of certain non-GAAP .
<unk> measures to the most comparable GAAP measures are available of BMS dot com without 100 over to Giovanni.
Thank you Tim and good morning, everyone before we discuss our first quarter results I'd like to address the leadership transition plan, we announced yesterday.
After 23 years at Bristol Myers Squibb, including the last eight as CEO I have decided to retire as CEO effective November one 2023.
So our family they can spend more time together in Europe .
I will continue to serve as executive chairman for a transition period to be determined by the board.
Given the strong foundation achieved to position <unk> for growth and success in the future.
Our strong pipeline and our incredibly deep bench of talent now is a natural time for this transition.
That's why I am pleased to share that the board has selected <unk> burner, our current chief commercialization officer.
Bristol Myers Squibb's next CEO as of November one.
Effective yesterday, Kris was named Executive Vice President and Chief operating Officer, and the Board also intends to appoint him as a member of the board after the annual meeting of shareholders.
In connection with Chris's appointment, Adam linked Koski SVP head of major markets has been named to succeed Chris as executive Vice President and Chief commercialization Officer.
The board and I are confident that Chris is the right person to guide to BMS through its next chapter of growth.
Since joining BMS in 2015, Chris has been instrumental in shaping our strategy and our culture.
His passion for science its commitment to our workforce and his tireless focus on our patients make him uniquely suited for the role.
Among a long list of accomplishments Kris has helped guide the evolution of our portfolio over the past several years, notably building, our leading presence in immuno oncology growing our CV business and launching multiple new medicines.
His deep knowledge of our strategy and pipeline and he is proven execution across all geographies and give us confidence that he's the right leader to drive Bms's vision to be the world's leading Biopharma company that transforms patients' lives through science.
Leading BMS has been the highlight of my professional career and I am incredibly proud of what our team has accomplished together.
I remain enthusiastic about the opportunities ahead and know that we will continue to put patients at the center of everything we do as we drive growth and sustained profitability.
Our patients for Sculpsure, coupled with our incredibly talented and diverse global workforce will continue to be the engine that drives our success.
I look forward to working closely with Chris through the transition and no.
There is a very bright future for Bristol Myers Squibb with Chris at the helm.
Now, let's turn our attention to our Q1 performance.
Starting on slide four.
As we continue to execute our strategy and accelerate the renewal of our portfolio I am pleased to share that we had a strong start to the year.
I am encouraged by the performance of the products that will drive our future growth.
During the quarter, our in line brands and new product portfolio grew 8% or 10% adjusting for foreign exchange.
Notably revenue from our new product portfolio more than doubled compared to a year ago Green.
Reinforcing our confidence that we expect to roughly double revenue from these products this year.
Home depot and <unk>, both performed very well with strong demand growth, particularly in the U S.
Looking forward, we continue to expect top and bottom line growth driven by our in line and new product portfolio more than offsetting the impact of generics and we are affirming our known GAAP financial guidance for this year.
Along with strong commercial execution in the quarter, we continued to advance our pipeline.
Turning to our scorecard on slide five as.
As you can see we delivered meaningful pipeline milestones in Q1.
We have a number of catalysts in our pipeline and made important progress expanding our new products, particularly with respect to regulatory achievements.
Starting with self with cell therapy, where we further strengthened our growing leadership position.
Following the publication of our Carmike fleet results for Triple class exposed multiple myeloma patients in the New England Journal of Medicine in February we have now delivered global regulatory filings across the U S Europe and Japan for this study.
We look forward to the opportunity to offer these transformational products to patients in earlier lines of treatment in multiple markets in the future.
We also continue to make progress expanding supply for both of our cell therapy products. We recently entered into an agreement for a vector facility in Libertyville, Illinois.
To further strengthen our supply chain and expand manufacturing capacity.
This will allow us to dual source vector supply and transition to newer higher efficiency manufacturing processes.
We look forward to supplying more patients with both our beckman and brands as capacity increases over time.
Our research teams remain focused on further improving outcomes for patients using cell therapy treatments, including with our exciting CD 19 next tea.
For severe refractory <unk> that is entering the clinic.
Turning now to <unk>.
As David will describe the launch for Black psoriasis continues to go very well and we are successfully establishing these products as the auto of choice for moderate to severe patients.
And during the quarter, we delivered approval of this medicine for patients in Europe .
In addition, we received data from our phase II trial in Crohn's disease and.
And while it does not support moving to a phase III trial at this time, we look forward to seeing data from the high dose UC trial later this year to evaluate opportunities for this asset in IBD.
Meanwhile, we continue to advance <unk> into key expansion opportunities in phase III studies for both psoriasis arthritis, and Lucas, which as you know has a very high unmet medical need.
And turning now to come values, we recently announced positive <unk> opinion for this medicine.
We look forward to bringing this product to European patients sooner.
Looking at our next set of Registrational assets.
We have initiated the phase III study for <unk> in post transplant maintenance during the quarter.
This study will potentially enable us to demonstrate superiority of <unk> over revlimid.
The early line setting of multiple myeloma.
And with our partners at Janssen, we are pleased to have now initiated all three phase III trials in the mill vaccine program.
We are excited about the benefits to patients from a potential next generation antithrombotic that is equal to or better than current factors than a drugs in terms of efficacy, but with a better bleeding profile.
As you can see our progress is strong with multiple exciting pipeline opportunities ahead.
Moving to slide six and tying together what this progress means for our new product portfolio.
This slide demonstrates that the renewal of our portfolio continues to gain momentum through a combination of strong commercial execution and the achievement of important clinical data and regulatory milestones that further derisk significant revenue opportunities.
I am very proud of the accomplishments of our global colleagues as they strive to discover develop and deliver transformational medicines to patients around the world.
Together, we have built the foundation for an even stronger company with a more diversified portfolio of growth products and increased durability across each of our four key therapeutic areas.
Given our growing and rapidly diversifying business and our financial strength and flexibility I'm excited about the opportunities we have for the rest of 2023 and beyond.
I will now turn the call over to David to walk you through our product performance and financial results in more detail David.
Thank you Giovanni and recognizing this is another busy day for all of you. Thanks again for joining our first quarter earnings call.
Turning to slide eight let's discuss our topline performance.
Unless otherwise stated all comparisons are made for the same period in 2022 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange.
Total company sales in the quarter topped 11 3 billion driven by strong double digit sales of our in line and new product portfolio offset by <unk> loss of exclusivity say.
Sales in the U S grew 4% driven primarily by volume while international sales were impacted by the <unk> of loss of exclusivity for Revlimid.
Let's delve deeper into the strong performance of the new product portfolio on slide nine as Giovanni mentioned, the new product portfolio generated over $720 million in sales, which more than doubled versus prior year and grew over 11% sequentially. This strong performance in the quarter was driven primarily by demand for <unk> <unk>.
And Red, Brazil, which I will touch on further in a moment and provides us confidence in the growth potential of our increasingly derisked and diversified new product portfolio.
Moving to our solid tumor performance on slide 10, global Opdivo sales were strong growing double digit versus prior year, primarily driven by continued demand for our newly launched <unk> indications.
In the U S. Opdivo grew 17%, primarily driven by demand in first line lung upper Gi indications and adjuvant bladder cancer.
Outside the U S first quarter revenues increased 18%, primarily driven by demand for recently launched indications and expanded access the.
Strong execution in the first quarter gives us confidence in the continued growth expected for Opdivo.
Now turning to the robust launch of <unk> sales in the quarter were $117 million growing double digit versus prior quarter. We're very pleased with the launch of <unk> of up to lag in first line melanoma with market share now over 20%, primarily as being sourced from PD one monotherapy.
Now turning to our expanded cardiovascular portfolio on slide 11, and starting with <unk>, which generated over $3 $4 billion globally, largely driven by the U S.
In the U S sales grew strongly up 19% driven primarily by robust demand.
Internationally sales were impacted primarily by generic entries in Canada, and the U K and pricing measures, we mentioned in the past.
Moving now to our first in class myosin inhibitor <unk> Paas, we continue to be pleased with the progress we are making to bring <unk> to more patients.
<unk> generated sales of $29 million in the first quarter now with approximately 2700 patients in our hub of which 500 patients on commercial drug at the end of the quarter, we continue to build momentum with considerable growth expected in the quarter over quarter.
We look forward to our upcoming <unk> date for Valor in June which will reinforce the strong profile for <unk> as well as the expected European approval, having just received a positive <unk> opinion.
Now turning to our hematology portfolio on slide 12, starting with Revlimid global sales in the quarter were approximately $1 8 billion impacted by generic entry as.
As we expected the favorability seen last year reversed in the first quarter and we continue to expect quarter to quarter variability.
Now onto <unk> global sales grew 2% versus prior year.
In the U S longer duration of first line treatments impacted new prescription volumes internationally revenues grew 12% driven largely demand for triplet based regimens as well as some buying patterns.
Turning to <unk>, which generated revenues of $206 million in the quarter sales were strong up 33% largely driven by demand in the U S. Revenues grew 18% primarily driven by continued total prescription share growth.
Internationally revenue represented more than doubled as we continue to secure reimbursement in additional countries, including being placed on China's national reimbursement drug list.
We are now launched in 25 countries outside the U S and expect to launch in additional markets. This year.
We look forward to presenting the commands data in an oral presentation at <unk> and EHR to further accelerate the brand by bringing this first in class product to first line Esa naive Mds patients upon approval.
Transitioning to our first in class and best in class cell therapy products effective <unk>, we continue to make progress in expanding capacity, which has enabled robust sales growth driven by strong demand.
With sales of $147 million in the quarter, we more than doubled our revenue for <unk> versus prior year and grew 16% sequentially.
We continue to be pleased with the feedback from physicians on the reproducibility of efficacy and safety in the real world and reliability of our manufacturing capabilities.
As Giovanni mentioned Karma, III and Triple class exposed myeloma patients now under review in the EU, The U S and Japan, and we look forward to bringing at Beckman to earlier line patients around the globe.
Turning to <unk> sales in the quarter was $71 million growing 66% versus prior year and 27% sequentially.
Sales were driven by demand in second and third line plus large b cell lymphoma with the broadest label in second line large b cell lymphoma, and differentiated safety profile feedback from physicians has been very strong and we are pleased with the strong demand for <unk>. We look forward to bring <unk> to earlier line patients in the EU and the <unk>.
Months with the recent <unk> positive opinion.
Let's now move to our immunology portfolio on slide 13, starting with suppose year global sales in the quarter were $78 million more than doubling compared to prior year in the U S growth was primarily driven by demand in multiple sclerosis, and expanding contribution from ulcerative colitis.
Internationally sales increased primarily to demand in multiple sclerosis, and securing reimbursement in additional countries.
Lastly, turning towards strong launch of our first in class <unk> inhibitor <unk>.
We're extremely pleased with the launch so far just six months into the launch we have over 9500 script equivalents across bridge and commercial drug.
<unk> share of the oral market is now in the mid thirties sourcing business from systematic naive patients as well as our Tesla and biologic experience patients.
Internationally, we are very pleased with the strong launch performance in Japan, and recent approval in Europe , and look forward to working with individual countries on securing reimbursement through 2023 and beyond.
We are very excited about particularly with non risk adjusted revenue potential four plus billion dollars.
Based on exciting opportunities ahead, and moderate to severe psoriasis psoriatic arthritis and in lupus.
Moving to our first quarter P&L on slide 14, I'll focus my remarks on a few non key line items just covered as I just covered sales performance.
In the quarter as expected gross margin was impacted by product mix. This was partially offset by favorable foreign exchange and related hedging settlements that will not repeat in the second quarter.
Operating expenses, excluding acquired in process R&D remained largely consistent with prior year Emerson.
<unk> declined 4%, primarily due to timing of spend which we expect to reverse going into the second quarter as we continue to invest in our new launches.
Acquired in process R&D in the quarter was $75 million, which was partially offset by $43 million of licensing income.
Overall first quarter earnings per share was $2 five growing approximately 5%.
Turning to the balance sheet and capital allocation on slide 15 cash flow generation and our balance sheet remained strong cash flow from operations in the quarter was approximately $3 billion.
With over $9 billion in cash and marketable securities on hand as of March 31.
As it relates to capital allocation, our priorities remain unchanged with BD continuing to be our top priority and a focus on balance sheet strength as well as returning capital to shareholders.
In the quarter, we repaid $1 6 billion in debt with an additional $2 3 billion maturing this year and we remain opportunistic share repurchases in the future with approximately $7 billion remaining in our share repurchase authorization.
Yeah.
Lastly, turning to our 2023 non-GAAP guidance on slide 16.
Based on upon the performance to date, we are reaffirming our non-GAAP guidance, we expect 2023 revenues to grow approximately 2% on a reported and constant currency basis, which reflects that our in line and new product portfolio will more than offset recent low.
Revlimid sales expectations remain at approximately $6 5 billion.
We'll continue to monitor variability from generics and other market dynamics through the year.
We remain excited about the promise of our new product portfolio and expect the portfolio to roughly double versus prior year. As we continue to launch these assets around the growth, we expect growth to be more back half weighted as we build momentum during the year. We continue to expect gross margin to be approximately 77%, which reflects a shift in product mix.
Accounting for the FX favorability in the first quarter, we expect gross margin for the first half of the year to be approximately 77%.
Okay. So a couple of questions first one so take too just wanted to get a sense of.
When you feel the free drug dynamic that's out there on the market today.
Is going to catalyze Ah switch <unk> to you know from kind of a loss of rebates of otezla to them really drive them towards appropriate reimbursement of so tech too and then just the second question from an R&D perspective, you mentioned lupus as it.
Relates to so take too.
Hoping to get a little bit more clarity on the discontinuation of the crohn's disease or the failure of the Crohn's disease trial as noted in your slide deck wanted to just get a better sense of of whether that study was stopped for efficacy or if there were any safety signals at all.
In that study that would be of concern and perhaps if you could share the dose that was explored in that study and and the ulcerative colitis study. Thanks, so much.
Seamus, maybe I'll start and then I'll turn it over to summit. This is Chris first the subject to launch just a as a top line messages going very well as David mentioned, we're seeing very good uptake in feedback from physicians from a demand standpoint, which is Ah to your question probably the most important thing that.
We can stay focused on in order to free up market access we're seeing very good progress in the quarter. We had over 9500 T. R X equivalents, we grew a new patient enrollments just shy of 40% quarter over quarter. So we feel good about those underlying dynamics and as you allude to as we continue to build that volume of patient.
<unk> will be able to be in a much better position to negotiate from a player standpoint, what I would say is that our focus continues to be on where possible pulling forward access decisions into this year that would mainly occur in the second half of this year right now most of the commercial drivers coming still.
From those patients who have open plans and had opened plans at launch but from a baseline standpoint, I would still consider 2024 to be the point at which you'll see substantive changes in market access, but we remain focused on on doing everything we can to pull that forward.
And thanks Christian thinks she a as for the question on the Crohn's disease data said, so let me start first of all they're saying is was already mentioned value as well as by David. So addictive continues to have abroad development program with the approval then psoriasis ongoing phase III studied in sporadic arthritis, as well as I said leave it to contribute to that $4 billion forecast that vehicle.
Always talked about.
On the Crohn's disease site, let's first of all remember that as a <expletive> to Ah mechanism of action perspective. Currently there is no proof of concept that is established for this spot in IBD as you remember in our face to local latest trial, we did not see a signal at that time and therefore, we had an ongoing.
Study with a higher do is that we will look forward to see the data of the back end of this year and Crohn's disease, we did not see a signal at this time. So we do not have a proof of concept and therefore, we're not going to move forward that has nothing to do with safety signal.
[noise] safe as we have always thought already published the data in many other studies at this time from the dose perspective, the doses tested in this particular study was three milligrams a V. I D. Six milligrams Vit more to come and represent the data in the future at a medical conference, but at the current time, we're looking forward to look at the data from you see higher goes trial.
Then have the totality of the data to make decisions of how we move forward.
Thanks, very much summit Gavin cause we go to the next question. Please.
Your next question comes from the line of Angie Paul Some city. Your line is open.
Thank you have questions summit and the questions Crystal maybe Adam given.
Change.
You highlighted slack key program I assume this is a copy against C. D 19.
I just want to confirm that this is contains fields of the <unk> switch and more importantly, the unlimited number of companies and that's very exciting space given.
I need to stay to last year, how aggressively are you seeing this in terms of timelines and breath. If he could talk to why you intend to go with this trial will constraints. The F. D. A put them given its and you sell construct and then how quickly you can expand morgues generally some sense of the left side.
That's inside Bristol to dress refractory auction disease, and then second Christian Adam the impact potentially well, we anticipated impact Medicare price negotiations.
<unk> is likely to be very substantial I'm curious as to the extent that you can reduce the rebate page P. B m's without facing peanuts of action, obviously, the pbms tried to exclude it from the portfolio some years ago and they ended up providing access again so.
How much leverage do you actually have to mitigate some fast impact onto the pbms. Thank you.
So thank you Andrew further question in a very appropriately.
In terms of wherever you're going as well as the platform. So if you recall the next the C. D 19, the one that you're using an essay Lee is the same platform that we've already tested actually and represented the data from their last year on our Hematological malignancies side, they're using that because it has a shorter turned it off.
Time, and we will be taking that forward in SLE now from a <unk> perspective, what I can tell you is that'd be submitted the <unk> to the F. D. A and we got a safe to proceed within one and after two months. So that shows the excitement not only for us, but also the productive dialogue and constructive dialogue, we had with the agency of how to move forward.
Our initial trial design is to do a phase one initiation and SLE read the proof of concept from external data does exist already so we wanted to go speedily and it's a global trial. So we're not limited to just the U S, but going to other countries, including the site that generated the data before in Germany, serving as the principal.
<unk>, So we're pretty excited and based on the data and the emergence of that data we have the capacity and capability to then expand to other indications, which we have not yet decided but certainly on track for that.
And then.
With respect to eloquence, Andrew I'll take that one so so as you know we do anticipate that <unk> will be impacted by government price setting a couple of things just at a high level to keep in mind first the timing of that impact will run up against the timing of our <unk> in the U S and second of course remember we split the economics on Ella close with Pfizer that Sir.
We do anticipate that eloquence will be in the early wave of I R. A price setting with respect to the ability of rebates to address that as you well know these are very competitive markets within that context. We are always trying to establish a very strong access position with the least impact on the value of our medicines through Rebating and I think we have.
Find but what I can come to choose that we're going to continue to negotiate commercial and Medicare rates and formulary position separately and we're going to be disciplined as we do so.
Kevin can we go to the next question. Please.
[noise] Considine, a quick shot of J P. Morgan your line of sight.
Oh, great. Thanks, so much just two questions here I guess, the first time like capital allocation front.
I guess, given the dilemma delevered balance sheet right now I guess, it's a two part question you've got a lot of launches that are ramping right now and I guess one of the questions. We've been getting is is their capacity in the organization for Bristol to pursue either near to market or market drugs. At this point or is the commercial organization kind of full with what it's doing and the focus should.
B, maybe more in the pipeline side on the Beady front and.
The second part of this is when I look at you got a 7 billion dollar repo outstanding you start starting at nine times earnings I guess, we're just rethought it was kind of fit into the mix as you think about capital allocation I'll leave it there. Thank you.
Thank you. Thank you for his visage of idea I'll I'll get started and then I'll ask David to comment so with respect to your question about our capacity for first of all supporting ongoing launches and potentially.
Looking at B development focused on later stage assets I don't see commercial capacity.
As a factor that would constrain our ability to do that we have fully resourced organizations across all four therapeutic areas.
Very effectively in the recent past so we definitely as I've always said.
Look at areas, where we have deep research development and commercial expertise first when we look at BD and there's obviously, there's clearly capacity from multiple perspectives.
Perspective is to continue to that assets to to.
To the portfolio. So when we look at business development. We look at early deals that strengthen the long term girl girl's profile of the company or pipeline is actually a really strong right now with respect to that and we also look at opportunities that have a meaningful shorter tomium.
Like we've done with Miaoke out of there and turning points, which are definitely models that are given the right circumstances, we would be happy to continue to support and I'll I'll ask David to give you a perspective on cabinet all location is it per Saint pertains to your second question, Chris. Thanks for the question and as you know business development remains.
Our top priority as far as capital allocations concerned as we look to continue to replenish the portfolio and add additional growth opportunities in the second half of the decade.
Also say is that we've been committed to delevering and you've seen that we've been able to do that we're down to two times debt to EBITDA, which gives us a lot of strategic flexibility from a business development perspective.
And also you know growing the dividend remains a priority for us we've grown a dividend for the past 14 years and.
That's a commitment that we.
As you've seen for the past 14 years and doing that and from a share repurchase you're right we have $7 billion in sure.
Authorization remaining and we'd look to be opportunistic as we move forward with that.
Thanks, very much David Kevin can we go to the next question. Please.
Your next question comes from the line of Tim Anderson of Wolf Research Your line is Hudson.
Hi, This is Adam on for 10, thanks for taking our questions so on and <unk>.
Has been a little closer far is Ren knee jerk eating factor when.
Can you comment on what per cent target prescriber.
Market Ramsey certified at this point and sent me back and how can we expect us to progress throughout the year.
Also at what point will of the majority of targeted Doc doctors ran certified too optimistic to think back to me by year end 2023.
Sure let me take that Adam. So first we're pleased with the continued rollout of <unk> to your question about room certified physicians, we actually saw about a 25% increase in Hcp's, who were room certified in the quarter. We're now at approximately 3250 the vast majority.
Dority of those are coming from our top tier accounts Ah we continue to drive utilization in those stopped your accounts and so if you remember we were targeting roughly 500 accounts at launch if you look at the highest.
[noise] highest volume of those those 500 accounts, we have utilization now in excess of 90% in those accounts were continuing to add additional utilization in those accounts every week and.
And then in the quarter, we expanded the team the eloquence cardiovascular team to begin targeting Ah accounts beyond those initial 500, the purpose being to continue to not only expand utilization outside of those institutions, but also importantly to increase referrals into.
Those institutions and we've seen a nice ah uptake in patients coming in for enrollment in fact, we saw about a 50% increase in the first quarter relative to the fourth quarter. So as we step back and look at it the rollout of Akins iOS continues to perform well we do anticipate that the majority of US will continue to be in those top tier accounts as you allude.
To we're seeing nice uptake and will continue to see uptake through the course of the year.
And I would expect that kept zygosis growth profile will continue to accelerate as we get further into the year as well.
Definitely curricular.
So do you go to the next question. Please.
Your next question comes from the line of Steve scholar of color. Your line is eitan.
Oh. Thank you I have two questions first can you describe the progression of Revlimid in 2023 on a quarter by quarter basis, and what are the primary drivers of that specifically was Q1 likely the high quarter in 2023 or will.
Will it be more volatile and then secondly, if I may Giovanni.
Given your experience tenure now transition any thoughts on the outlook for the industry over the next decade on pricing IP ability to be continually innovative would be helpful is the industry just headed for death by a thousand cuts.
Or will the future be more like the past and we know there's huge unmet needs. So so we're more looking for what's likely to happen. Many thanks.
Thank you. Thank you for letting me. Thanks for your question. This is Giovanni.
Lots of briefly the the second question, obviously be happy to continue to dialogue and then I'll ask David to give you the answer on Revlimid listen I think as I step back and think about where the industries.
Most important point.
Point is that science is progressing faster than ever and quite frankly, you know as I have to step back and really thought about the last few years, the immune oncology impact of cancer on cancer care has been extraordinary I personally believe that cell therapy will be as impactful going forward earlier today in the.
We discussed.
What's happening in terms of hematologic malignancies, but also the potential to expand to other immune diseases and and one day solid tumors I think that will be modality that will have a really big impact in the industry. I think we're very well positioned as the leader in that sector. So you know I I personally think.
That Ah science will continue to be creating exciting opportunities I I also believe that when I look at what is happening at B M. S. We are now beginning to see the impact that.
Data technology, the digital transformation, we invested in for many years is beginning to have in terms of fundamentally accelerating R&D efforts and produce TVT I think that's gonna be a really important for us to bring the full pipeline to bear you are right that there are.
Meaningful headwinds from an access and pricing perspective everywhere around the world.
And I think that just raises the bar for innovation, but I do believe that.
That companies like BMS will continue to be successful just because of the strength of science.
David and Steve Thanks for your question on relevant.
A couple of things one just reaffirming the full year guidance of six and a half billion on revlimid as.
As far as quarter to quarter, you should expect to see continued variability because we really don't control how the generic spring product to the marketplace, but as you're thinking about it just a couple of points for you to consider one remember we had a better cue for then we're anticipating so we think some of that has come out in Q1 also the other thing I'd remind you of Q1 of.
Last year. His first we saw a generic entry really didn't come in until the February timeframe in Europe and in the U S. It was March so Q1 of last year's our toughest comp, but look I think the main takeaways here is we're still thinking about this a six and a half billion dollars for the full year. We continue to expect that we're going to have variability and we'll update you as the year progresses.
On that.
Thank you thanks.
Definitely go to the next question please.
Your next question comes from the line of Christian <unk> from Goldman Sachs. Your line is open.
Thank you very much Giovanni I appreciate your tenure, Chris Congratulations and Adam as well my question in terms of as you think about what you bring to bear from your commercial experienced Chris.
You think that on the forward that Bristol and industry has the right structure strategy and footprint in terms of thinking about commercializing in the U S as well as in Europe .
And then secondly related to that if I could also ask about the immunology portfolio overall, good initial attraction with <unk>, It's an area where the company historically had a bigger presence seems to be reemerging. How are you thinking about what do you have a critical mass in that realm, and how intrigued argue about focusing potential business development in that area.
Thanks for the question.
So we take that so first let me just say in terms of the transition I'm, absolutely thrilled with the opportunity. The past eight years have been really the highlight of my career here at B M. S and I'm certainly looking forward to taking on the broader opportunity and continuing to work with the absolutely exceptional talent that we have at the company across.
All aspects of the company with respect to the structure and how that so evolving first I think that if you look at Ah BMS. Historically, we have always evolved how we're organized where we place our resources, how we allocate those resources across channels to be aligned with Ada portfolio, we have and.
B the environment that we're operating in and I think that just.
At a macro level, that's how I would think about how we're going to continue to operate going forward is Giovanni just alluded to in the previous question. There are obviously puts and takes in the industry. There's a lot to be excited about there are also some headwinds and so as we constantly are looking at the commercial model. We're staying focused on aligning that model to the world We live in.
And clearly digital because it's going to continue to play a much bigger role. We do believe that there will continue to be personal interactions required with key stakeholders health care as in is by its nature of personal interaction.
The the size and focus and orientation of those personal interactions will undoubtedly evolve and we're going to continue to stay ahead of all of those trends.
As it.
Respect with respect to immunology, specifically, that's an incredibly exciting area for us as you've alluded to we have had a presence in that space with a <unk>. We're very excited about both <unk> and the.
Launch with subject to and as we've talked about on this call. There's considerable opportunity to continue to grow that presence over time, that's required all ready for us to build additional capabilities. In for example market access which is a different dynamic and immunology versus oncology and then we're going to continue to make sure that we're allocating resources to ensure that that Ah.
Particular portfolio is very successful commercially both in the U S and X U S.
Alright, Thank you can't really go to the next.
So the next question please.
Your next question comes in on it just Meacham a bank of America. Your line is open.
Good morning, guys. Thanks for the question you also wanted to start by saying our best wishes Giovanni you will be missed and congrats to both Chris and Adam.
On the lifecycle management for up Devo Abdul lag has some pretty strong demand can you talk about what do you think you could go beyond long I wasn't sure what was supported by the mechanism or any newer data that you have and then secondly on subcutaneous Lucky, though maybe you're talking about where this falls and your priorities across.
A pipeline and then what your expectations are for additional IP. Thank you.
Sure. Thank you, Jeff with a question for up to a lack let's first of all a review.
A large program already underway number one already approved and the first line metastatic melanoma number two abdomen.
We are looking forward to the read out of that trial number three the registration trial ongoing and colorectal cancer nemesis stable patient population again looking forward to that read out in the coming year or two.
And then beyond that the proof of concept studies that are already ongoing and non-smoker lung cancer. We are conducting a randomized phase two study to generate the data and also to look at the.
Progression free survival that'd be compare combination of abdul leg with chemotherapy comparing it to a single agent, Iowa, plus chemotherapy. So that'll be very important data set to define our bad forward a nonsmoker lung cancer. In addition to that we have the programs I'm going and if that is a look or something I might as well and there was a large investigate initiated program that is ah going in parallel.
Though to see where the signals might be generated as we look forward.
From this up to up to your perspective, certainly are excited about that in terms of looking at it read out you know that the registration drug was ongoing and he knows how cancer and as is the general practice. The application. If if it is successfully and if it is approved and the application would be good for all other indications.
<unk>, we're going to go to the mat today is used as a single agent from a commercial perspective, maybe cause if you want to comment on that sure I think some it's covered most of it but I would say that we've always thought about subcu is something that is mainly focused on.
Pushing the science forward and being able to support the needs of our customers and in that regard, we see subcu potentially playing an important role in those accounts were chair time is at a premium it could be particularly important and for example, an adjuvant setting where physicians may not need to have a more involved conversation with patients when they come.
In and there was a desire to get patients in and out and back on with their lives over an extended period of time and so that's where we see subcu playing a particularly important role I know there's been a lot of questions around the impacts of this under I R. A I think it's still unclear in too early to talk about that but.
The way, we think about Subcu is very much and how do we improve the profile of this modality for for customers and probation.
Can we go to the next question please give them.
Your next question comes from the line of parents Lynn of Morgan Stanley . Your line is open.
Great. Thanks, so much for taking my question my congrats to Chris as well invest Giovanni in your retirement.
Maybe a two part one just wondering on rebels on first line I know, we'll see the command state I'd ask but just maybe you could speak to your confidence in a broad first line label and then given the recent cartoons for data for a competitive product I'm. Just wondering how you think about the competitive positioning here have a backup once.
We see supply normalize in the car T space for myeloma. Thank you.
So thanks for the questions for that blows it'll come on so that's it again look it up those little command study was conducted in an all come or patient population to both artist positive an artist negative certainly you'll see the data being presented it at school and we can have a longer discussion at that time, but overall. This study that are positive we made the primary and.
Even at the secondary endpoints as well very important to note that in general the longevity of that Ah Ah transfusion independence is a very critical factors that a bunch of observed doing the presentation, because that's what matters in the real world ended the patient how long they can stay away from transfusion. So overall, we are actually quite excited about the data in a.
Of course regulatory interactions will continue.
I'm a commercial standpoint on commands and then we'll talk about the competitive dynamic you mentioned.
I think it's important to recognize that command is a very important opportunity commercially bolt in the U S and potentially outside of the U S. At roughly doubles the size of the N D S opportunity and some it just alluded to it's important to keep in mind the significant unmet need in this space chronic anemia and Transfuse independence.
For lower risk Mds patients across the board as a significant challenge it there's a significant risk of death at roughly 50% greater compared to transfusion independent patients and while ESA is are the dominant first line option for these patients we need to remember that efficacy and duration of response is very limited. So we view this as a.
Potentially very attractive commercial opportunity.
As as it relates to the competitive dynamics with a beckmann, obviously data in this space continues to evolve very quickly both with respect to the car to to data and our own Karma three data as when you think about it first and foremost we need to see the data we need to see the details of these data, but as we've consistently said.
As the data progresses with car teas, and hematology, we're seeing real patient benefit and I think that's very exciting for patients across these products. We continue to see the importance of D. C M. A targeting and most importantly, as we said from the very beginning we see the room for multiple competitors to operate in the space and that.
Continues to be our view. It is however important to keep in mind that Karma three car to toot for have two different patient populations. So it's difficult to compare these two studies and Karma three we intended to design a study that reflects the patients that physicians see we enrolled patients who are more difficult to treat the vast majority of them.
Dare refractory all of them are triple class exposed and so these are patients who you can think about being more third to fifth line patients. So I think it's gonna be really critical that we see the full data sad and then we take that data set into consideration with respect to how these products are performing in the real world and what we consistent.
Lee hear from customers as they wanted to see efficacy and safety that our lines in the real world to what they saw on the clinical studies and they Wanna see manufacturing reliability and we think those are all going to be important to keep an eye on us as the full datasets get presented.
Okay, Let's go to our next question please.
Your next question comes from the line of <unk>. Your line is open.
Good morning, Thanks for taking the questions and Giovanni best of luck in the future.
I guess two from me first on I'd Love to hear how you guys are thinking about sort of the frontline opportunity in hodgkins, obviously, we're going to see the late breaker nivolumab for sprint tucked, some I've been at ASKO, but I could that NCI data under certain circumstances be registrational, how you're thinking about that and then some of it to whatever extent I can get you to.
Comments on sort of the next generation took two acid and how you think about differentiation there versus static too.
Sure. Thank you Gotta look up on the first question on the Huskins lymphoma data.
The date of course as you know that this was a coop cooperative groups, so I'll get that.
Conducted this study so it is not sponsored by the M S. But as we look at the data and they're supportive Sir.
Certainly as appropriate and gave the authorities, but certainly very excited to see that the data has come up positive that could be really beneficial for patients.
In the future in terms of the next generation Dictu inhibitor.
In the early stages of we've just initiated a program of phase one study and then looking into Sir I says right now, but we are involved with the data we have a deep expertise in deep knowledge of the three by three as well have psoriasis, so we'd be able to contrast, and compare and defined the clinical development behind going as we go to the future for additional indications.
And look for differentiation as well so more to come but at this time, we are just beginning those studies.
Go to our next question please gallon.
Your next question comes to nine have Robyn.
Okay from Trust Securities. Your line is open.
Great. Thank you just to come on up to like it looks like your grocery <unk> market share a quarter over quarter or so I'll make a little bit could you just give some dynamics of how you think how much more penetration you can get into the melanoma space and then second he's just going back to the lung read out this year a lot of other companies are.
Focus on different I O I O combos.
What is your thought on the bar for success that you want to see and then how do you think it'll take like mechanistically compared to other Io compounds that other companies are developing.
So maybe I'll start and then I'll turn it over to summit look we're very pleased with the continued uptake of Abdulla lag as I think it was referenced earlier the shares are now over 20 per cent keep in mind. We're also seeing some use and in the second line plus setting.
There are a few underlying dynamics that were particularly happy about first we're seeing roughly 65% of the utilization coming from PD, one mono therapy and remember that is the lowest hanging fruit for continued growth of this of this product and we see mono therapy is still in that 15 to 20 per cent range in terms of using the first line setting the so there.
Still considerable opportunity to grow there we are seeing some physicians source from up Devo. Your avoid those are mainly physicians who have some concerns about your voice toxicity, but we would envision that that will continue as well so that's an additional opportunity.
To grow this business the other thing I would note is that.
During the first quarter, we actually saw an NCC an update and add.
Update is really important because what it did was it removed be racking neck inhibitors as a preferred treatment and in the first line setting and so now when you look at preferred treatment options and first line melanoma. They are all dulia, either Devo, you avoid or abdulla lag and I think that's a really important recognition.
<unk> on the importance of July .
July Oh therapy targeted in that first line setting up do lag is going to continue to play a really important opportunity there and then beyond melanoma clearly summit has already articulated at some of the opportunities there stomach.
Plus chemotherapy it gives us two elements one is the contribution of.
Lastly, map to abdulla less chemotherapy and second the differentiation and superiority. If we can find one and N. P. F S and that's what we're trying to gather and that data will then pave the way for initiation of our phase III program and in terms of other iron mechanisms in comparison, I think you're alluding to some of the others are such as the digit program.
Ongoing and those are yet to be proven we are certainly looking forward to more and more data presentations. We have two of our programs already in that space as well and we as we generated the data and we look at the external data reading out towards their final stages, you'll be able to define and decipher where the application should be four which agent and hopefully Ah.
Let me see the data and defined then future combinations as well with those agents.
Thanks, Kevin Kevin we're running short on time or maybe it's time for two more can we go to an excellent.
Your next question comes from the lineup claim per Se of UBS. Your line is open.
Hey, good morning, I want it to.
Congrats Chris Giovanni.
Giovanni all the best in the future.
I guess in terms of the clinical read out we're gonna get from you. This yet you know the main ones that we're getting the questions I don't stick out at the phase two and Ips.
You see and then <unk> I wanted to if you could just walk up to your expectations. Each of these and maybe even offer which one you're most enthused about thank you.
Thank you so Ah [laughter] Ah since I don't have an eight ball I'm enthused about everything.
Conduct the studies of course that'll be one data presentation is coming up very soon.
That data has given us excitement and encouragement to be looking forward to initiation of the phase III draws in IPF as well as M. P. P F.
Already talked about the Crohn's disease data that it did not have the proof of concept yet for a tech to inhibition mechanism in IBD and looking forward to that read out certainly later this year really have we are looking forward to the nonsponsor lung cancer eat out late this year or early next year.
Four abdulla, Oregon that will pave the way for the future, but we also have several other eat out if you think about cell therapy, we might have the ability to look for the date of an additional indications for <unk> as well and that would be important. He was also see the data for CLO study being presented to the high school, which is going to be important in addition to what we talk.
[noise] about four command as well so those are all going to be critical and we're looking forward to having a more and more in terms of our pipeline successes that'd be look to the future.
Hi, Kevin Let's go to our last question. Please.
Your last question comes from the trunk.
Your line is open.
<unk> from credit Suisse. Your line as I can.
Your next question comes from the line of lithium prayer from cancel your line is open.
Hi, Good morning, and thank you for your question it looks like <unk>.
This continued and kind of medications and phase three just to kind of hear development side. So can you give us any more color on what led to that decision and what it means that keep program going forward and then if I can just sneak in one more how much added capacity does your and your last cell therapy manufacturing facility get Ya.
Is that is that something we should start to expect to contribute to supply this year or should we be thinking about that more as of 2024 a driver.
Yeah sure. Thank you I've yet for the first question on sub cute and those so let's clarify that there are two separate your program that we had for a D. One was a syringe involved which is the one that we talked about before in the and reynoso kinds of the study that we're looking forward to read out the other program that'd be very initiating was the auto injector program and that.
The one that we have discontinued we didn't see Ah Ah more additional benefit of continuing that program. At this time. So we will certainly how 'bout eat out of this up to your program and the phase III and reynoso carcinoma, and as I said earlier, if the data are supportive and an appropriate then of course discussions.
But on sue for applying that to all the other indications there'll be with US today as a single agent and let me quickly take the capacity questions. So first as you look at cell therapy across the board. We are increasing capacity, we anticipate to continue to increase capacity this year as well as going into next year that said within the context of the.
Carty you have to say consistently focused on manufacturing and remember we have a threefold approach to how we're doing that first we're staying focused on manufacturing success rate. That's important on the reliability point that I made previously second and this is where the Illinois facility comes into play as we've got to increase vectors supply we have a dual sourcing strategy.
For that both leveraging external partners as well as internalizing vector and.
And clearly the acquisition of the Liberty Bill facilities and important in that regard and then finally of course is drug product in there we've made a number of investments including facilities in devins, Massachusetts and enlightened in the Netherlands asked for when the vector facility in Illinois will be up and running we need to take complete we need to take ownership.
But the facility first and then we've got a complete all of the site Onboarding and there is a fairly complex process in terms of tech transfer that's going to be required. So we anticipate it's gonna take about 18 months from when we fully acquire the site, which would put that meaningfully contributing as we get into 2025.
Thank you, Chris and stomach, thanks, Olivia and thanks, everyone. So to summarize.
Saddam start of the year with double digit growth of our in line a new product portfolio on track for the year to grow.
Top and bottom line as we discussed earlier.
And we feel good about where we are after the first quarter of the team will be available. After you are very busy day to answer any other questions. You may have it and I want to thank all of you for participating Nicole. Thank you and have a good day.
That doesn't kind of conference for today. Thank you for participating amendment will disconnect.
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Yeah.
Yeah.
Mhm.
Mhm.
Yeah.
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Yeah.
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