Bristol-Myers Squibb Q4 2021 Earnings Call Transcript

Quartr
Provided by Quartr
February 3, 2022

There are 16 speakers on the call.

Operator

Good day, everyone, and welcome to the Bristol Myers Squibb 20 21 4th Quarter Results Conference Call. Today's At this time, I'd like to turn the call over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

Speaker 1

Thank you, Alan, and good morning, everyone. Thanks for joining us this morning for our Q4 2021 earnings call. Joining me this morning with prepared remarks are Giovanni Cafforio, our Board Chair and Chief Executive Officer and David Elkins, our Chief Financial Also participating in today's call are Chris Berner, our Chief Commercialization Officer and Suman Hirawat, our Chief Medical Officer and Head of Global Drug Development. Conference call. As you'll note, we posted slides to bms.com that you can follow along with for Giovanni and David's remarks.

Speaker 1

And before we get started, I'll read our forward looking 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 is a result of various important factors, including those discussed in the company's SEC filings. These forward looking statements represent our estimates as of conference call. Today's conference call is 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 conference call will also focus our comments on our non GAAP financial measures, which are adjusted to exclude certain specified items.

Speaker 1

Reconciliations of certain non GAAP financial measures to the most comparable GAAP measures are available on bms.com. And with that, I'll hand over to Giovanni.

Speaker 2

Thank you, Tim, and good morning, everyone. Let's start with our 4th quarter performance on Slide 4. I'm pleased to report we delivered another strong quarter, building on our very good performance throughout 20 conference call. Our commercial results were strong across the portfolio with robust performance in our continuing business conference call is driven by Eliquis and accelerated growth for Opdivo as well as continued demand growth for our new products. Conference call.

Speaker 2

The launch of ZYPOZIA in ulcerative colitis is progressing well in the U. S, and we obtained European approval during the quarter. Conference call. We are pleased with continued demand growth for Revlozo in ESA refractory MDS and transfusion dependent beta cell. Conference call.

Speaker 2

Let me highlight some key achievements. We submitted applications for ducarvacitanib in the U. S, EU and Japan, conference call, which position us well to grow our presence in immunology. We are excited about the potential of duclavacitinib conference call is the oral standard of care in moderate to severe psoriasis and various other autoimmune diseases. Conference call.

Speaker 2

We are expanding our cardiovascular portfolio and presented exciting data at for NOVXIEN, which we see

Speaker 3

conference is a next generation

Speaker 2

antithrombotic with a $5,000,000,000 plus non risk adjusted revenue opportunity. We presented important updates at ASH on our hematology pipeline. This includes encouraging data for iberdomide and Our exciting new multiple melomat cellmod agents. These have the potential to replace Reglimid and palmaristovertime. We reported 8% sales growth and double digit non GAAP EPS growth.

Speaker 2

Our strong cash flow financial strength provide us with significant financial flexibility. This enables us to continue prioritizing We also introduced our 2022 guidance last month, and I'll let David speak to the details in a moment. What's important is that we are guiding to growth this year with low double digit growth from our continuing business, more than offsetting At the beginning of last year, I outlined a number of milestones that we believed would be important to our future, conference call, including opportunities to renew our portfolio and grow our business during the decade. I am pleased to report we have made great progress. Conference call.

Speaker 2

We returned Opdivo's growth, successfully launched multiple new products and produced key expansion data sets for several assets. This record of execution across the company further strengthens my confidence in our ability to continue to renew our portfolio and grow in the future. We know we must remain focused on advancing our pipeline to accelerate the renewal of our portfolio. Conference call. And on Slide 6, you can see there are multiple catalysts ahead during 2022.

Speaker 2

The 2022 milestones include expected approvals and launches for 3 exciting first in class medicines, mavacamten, ducravasitinib and rolasinib. Conference call. We believe that all of this have the potential to further strengthen the commercial opportunity for our new product portfolio and support our growth outlook. We expect that each of these assets has at least €4,000,000,000 revenue potential at the end of the decade on a non risk adjusted basis. We look forward to keeping you updated on our progress throughout the year.

Speaker 2

Looking to the future, Slide 7 summarizes our perspective of how All of this comes together to support the growth of the company moving forward. We expect the growth in our continuing business will enable us to more than offset key LOEs through 2025, with continued growth of our in line brands conference call. In the second half of the decade, with a broad and expanding product portfolio, we will have multiple conference call is to achieving our growth objective from 2025 to 2029. As we said, conference call, we expect more than $25,000,000,000 in non risk adjusted revenue potential from the current new borrower portfolio in 'twenty nine, conference call with additional contributions coming from our pipeline, including assets like IMILVEXAN and our exciting Selmon agents. As we continue our journey to renew our business and grow through the impact of LOEs starting this year, conference call, I'm increasingly excited about the future of Bristol Myers Squibb.

Speaker 2

With that, I'll turn it over to David to walk you through the financials. David?

Speaker 4

Conference call is open. Thank you, Giovanni, and thank you all for joining our call today. I'd like to start with our strong top line performance on Slide 9. We We closed out the year with another great quarter across our key franchises. Revenues grew high single digits versus prior year, which was driven primarily by increased demand

Speaker 5

conference call for our

Speaker 4

in line and new product portfolios. Now let's turn to some product specifics starting with Eliquis on Slide 10. Eliquis continues to deliver extraordinary growth with global sales up 20% for both the Q4 and the full year. In the U. S, Q4 sales increased 22% versus prior year, driven primarily by total prescription growth of 13%.

Speaker 4

Internationally, Eliquis sales growth continues to be driven by increased share across all key markets and the brand remains the number one OAC in multiple countries. Looking forward, the growth outlook for Eliquis remains strong as we continue to grow the oral anticoagulant class and increase our share within the class. As a reminder, the Q1 of 2021 did experience a one time favorable true up in the U. S. Of approximately $160,000,000 that will not repeat in Q1 of 'twenty two.

Speaker 4

Moving to Optiva's performance on Slide 11, we are very pleased with the accelerated momentum growing 11% globally versus prior year. This is driven by strong demand particularly for our new launch indications. Conference call. In the U. S, 4th quarter revenues were strong, up 16% versus prior year.

Speaker 4

Growth was primarily attributable conference call is due to the approval of adjuvant esophageal and adjuvant bladder cancers in 2021. Internationally, 4th quarter revenues grew 5% versus prior year, driven largely by demand for new indications and expanded access primarily in emerging markets. More broadly, we continue to see uptake of our new launches in lung and renal cancer in Germany and Japan. And we secured reimbursement in Italy and Spain in the Q4. As we look forward, we continue to expect further growth for Opdivo as We're in a strong position to continue to grow Opdivo and look forward to additional approvals this year and in the years ahead.

Speaker 4

Now let's turn to our image portfolio on Slide 12, starting with Revlimid. 4th quarter revenues grew 1% globally versus prior year and grew 6% for the full year with sales of approximately $12,800,000,000 As we enter into the 1st year of generic entry for Revlimid, I want to remind you of our presentation for Revlimid sales in 2022 and beyond. We expect Revlimid sales of $9,500,000,000 to $10,000,000,000 in 2022. Of these sales, we roughly 75% to come from the U. S.

Speaker 4

And the remaining from ex U. S. Markets. As we think about generic entry this year, conference call. We expect sales variability quarter to quarter based on the timing of how generic competitors fulfill their annual volumes.

Speaker 4

For the Q1, conference call. Our best projection for global Revimid sales is approximately $2,500,000,000 Beyond 'twenty two through 2025,

Speaker 5

conference call. Although there is still

Speaker 4

uncertainty due to ongoing litigation, we view an annual step down of roughly $2,000,000,000 to $2,500,000,000 per year as a reasonable projection. Now on to POMALYST. Global sales in the 4th quarter were up 2%. Sales were primarily driven by demand for triplet based therapies in ex U. S.

Speaker 4

Markets conference call and fewer selling days in the U. S. We continue to expect growth for POMALIS as treatments move to earlier lines of therapy

Speaker 5

conference call, and more triplet based therapies are approved with longer duration of treatment.

Speaker 4

As it relates to USIP for POMALYST, we are pleased that there is now conference call is no outstanding litigation. At this point, we don't expect generic entry in the U. S. Market prior to the Q1 of 2026. Now let's move on to our new product portfolio on Slide 13.

Speaker 4

We are very pleased with the momentum and feedback we're receiving on our new product portfolio. Conference call. These products contributed over $350,000,000 in the 4th quarter and $1,100,000,000 for the full year. Conference call. Let me provide some color on each launch individually, starting with REBLOCELL, which generated global revenues of just over $550,000,000 in 2021, conference is more than doubling its revenues over last year.

Speaker 4

In the U. S, full year sales grew 87% versus the prior year, primarily due to continued demand in ESA refractory MDS patients. Demand continued to grow in the 4th quarter. Sequentially, revenue was impacted by one time favorable inventory build in the Q3 of approximately $20,000,000 to $25,000,000

Speaker 5

conference call is being recorded.

Speaker 4

Our focus remains on treating new patients earlier in their treatment journey upon ESA failure, as well as ensuring physicians conference call to receive the appropriate dose for sustained benefit. Internationally, we continue to launch in additional countries and expect conference will continue to do so in 2022, helping more patients and driving additional growth for the brand. Now moving to our cell therapy launches of Beqma and Briyansy. Beqmed generated revenues of $164,000,000 since its launch in May of last year. Revenues reflect very strong demand for the first ever BCMA call is being recorded.

Speaker 4

As noted in the past, demand continues to be very robust and we're working hard to expand capacity. Conference call, we expect Q1 revenues to be largely similar to Q4. Turning to our CD19 cell therapy, Briansy. The treatment paradigm in the second line setting with remarkable EFS data presented from our TRANSFORM study at ASH and we look forward to bringing this treatment to second line patients in the U. S.

Speaker 4

This year. Conference call. Now moving to Symposia, global sales for the year were $134,000,000 primarily driven by our multiple sclerosis indication. Conference call. In the U.

Speaker 4

S, the MS launch continues to go well. ZUPOSIA remains the leading S1P in written prescriptions and we remain focused on establishing Zuposia not only as the S1P of choice, but also the oral treatment of choice. We recorded. We continue to be pleased with the progress we have made on patient conversion. With significant decrease in time, physicians are responding well to the call will follow and we are encouraged by their intent to prescribe.

Speaker 4

We are working on building volume and growing access and reimbursement. We expect to have increased contribution from UC in the second half of this year and expanding in 2023. Internationally, ZAPOSIA continues to gain momentum in MS conference call is available on our website. As the

Speaker 6

product gets additional reimbursement in more markets and benefited from

Speaker 4

year end stocking, we are very pleased with the recent EMA approval of UC in December and look forward to securing access and reimbursement for this indication to drive further growth for the conference call is being recorded in the conference call. Overall, I'm pleased with our new product portfolio performance and look forward to 3 additional approvals expected this year. We are launch ready for rilatinib and mavacamten with PDUFA dates in March April, and we're on track for ducravasitinib's launch in September. Now switching gears to our Q4 P and L on Slide 14. Having just covered sales performance, let me walk you through a few non GAAP key line items.

Speaker 4

Operating expenses increased versus prior quarter due to timing of MS and A investments that shifted to the 4th quarter as noted in October. Is 25% year over year. Moving to the balance sheet and capital allocation on Slide 15, We continue to generate a significant amount of cash from operations with approximately $4,000,000,000 in the 4th quarter. We ended the quarter in a strong liquidity position with approximately $17,000,000,000 in cash and marketable securities. Our capital allocation priorities remain unchanged.

Speaker 4

Business development remains our top priority to further renew and diversify our portfolio. And we are also focused on reducing debt and returning capital to shareholders. We have executed several business development deals last year, conference call is now bringing in differentiated early stage assets. We have the financial strength to be diagnostic, but we are particularly interested in early science and midsize bolt on deals. As it relates to debt, in 2021, we reduced gross debt by over $6,000,000,000 and remain committed to maintaining a strong investment grade credit rating.

Speaker 4

Lastly, as it relates to returning capital to shareholders, we recently grew this authorization by $15,000,000,000 conference call and plan to execute a $5,000,000,000 ASR this quarter. Now turning to our 2022 non GAAP guidance at current exchange rates on Slide 16. Conference call is being recorded. As announced last month, we expect 22 revenues to be approximately $47,000,000,000 representing low single digit growth over 2021. Growth from our continuing business will more than offset the revenue impact from Revamin and Abraxane LOEs.

Speaker 4

Conference call. We expect key LOE brand sales to be approximately $10,500,000,000 and our continuing business, which represents our in line and new product portfolios, conference is expected to grow low double digit and contribute approximately $36,500,000,000 As it relates to our line item guidance for the year, we expect our gross margin to 78% and our total operating expenses to be in line with 2021 expenses and we project our tax rate to be approximately 16.5%. Finally, also communicated earlier this year, we expect non GAAP EPS to grow faster in sales conference call will be between $7.65 $7.95 As it relates to our share I'd like to provide a little color as we plan to execute the $5,000,000,000 ASR. We ended the year with approximately 2,200,000,000 diluted shares outstanding. Conference call will be executing the ASR later this quarter, which means we will get a majority, but not all of the benefit on diluted share count this year.

Speaker 4

Lastly, given this is the Q1 of generic entry for Revlimid, we thought it would be helpful to provide some perspective on revenue for the Q1. Conference call. In addition to the approximately $2,500,000,000 of Revlimid sales I mentioned previously, we are projecting total global first quarter sales to range from $11,000,000,000 to $11,500,000,000 So before I turn it over to question and answer, I just want to thank our teams around the world for delivering these remarkable results in 2021. These results and our guidance for 2022 demonstrate the financial strength of the business

Speaker 1

Thanks, David. Alan, can we go to our first question please?

Operator

Certainly, sir. We'll go first to Seamus Fernandez with Guggenheim.

Speaker 7

Thanks so much for the questions. So first question is just on Your Factor XI, just wanted to check-in on timing of the potential update from your Phase 2 study. Conference call. And just wanted to get a sense of where your expectations are as we've spoken with thought leaders in the space. The hope is that the increase conference call.

Speaker 7

In the dosing or the stepped up dosing would result in no bleeding increase, but with roughly a 15% to Help us understand a little bit better the opportunity to open up this potentially new market and how you see the conference call, your we just had the filing of the Cytokinetics competitor compound. Can you just talk a little bit about the competitive landscape conference call, as you think about the opportunity for navacamten versus other competitor compounds? Thanks so much. Conference call.

Speaker 1

Thank you, Seamus.

Speaker 6

This is Samit. I'll take both of those questions. So for Factor XIa, as we have talked about, the second Phase 2 study, is in secondary stroke prevention. We expect to have the data in house around the middle of the year. And at the appropriate conference, we will be able to share that data beyond that.

Speaker 6

And we are continuing to work with our partners Janssen to really execute on the future development of melbixin. As your question related to What the data would show and what the acceptance and availability would be and applicability would be from a bleed perspective or perspective. I think we just have to wait to see the data. The primary goal for these studies is to be able to isolate Well, the impact is on the bleed as we look to combine it with the background therapies of antiplatelet agents As well as to then progress them further into appropriate indications either as a single agent or as combinations. So we just have to wait for the data.

Speaker 6

Conference call. But as we saw in the TKR study, there was no increase in the bleeds, but we certainly saw increase as a dose dependent in a dose dependent manner from an efficacy So let's wait for the middle of the year to see the data and then we'll define

Speaker 5

conference call is being recorded and

Speaker 6

we are now looking at the future trajectory for the development of that. Coming on to mavacamten and the competitor compound, we remain very conference call is focused and very confident in the data for mavacamten. As you know, we are launch ready, as David spoke earlier, for the PDUFA date coming up conference call. And as it relates to then a small amount of data that has been talked about from I think 13 patients conference. Looking now at a different cohort in combination with isoparamide.

Speaker 6

Certainly, we in our EXPLORER trial have looked at The commonly used background therapies are beta blockers and calcium channel blockers. In the VALOR trial, we do have patients who are going to be receiving the background therapy of will provide us well. So we do not see a differentiated profile at this time from a competitor perspective. We certainly are confident that we already have a Phase 3 trial that has been submitted and the 2nd Phase 3 trial that is going to read out in the short term.

Speaker 8

The only thing I would add, Seamus, is just on MAVA. As we've discussed previously, the current standards of care for these patients conference Really aren't focused on targeting the underlying nature of the disease. So we feel good about the competitive environment when we launch. And as Amit mentioned, We don't see any differentiated competition on the horizon. And certainly based on the public data that we've seen thus far from competitors, it's entirely consistent with what would be expected from a myosin inhibitor.

Speaker 8

And so we feel very good about the competitive position for this agent and look forward to launching.

Speaker 1

Thanks, Chris. Alan, can we go to our next question, please?

Operator

Certainly. Next, we'll go to Chris Schott with JPMorgan. Conference.

Speaker 9

Great. Thanks so much. Just to be a follow-up on mavacamten. Can you just help set some expectations about how we should be thinking about the launch here? Conference.

Speaker 9

I guess, is this a product given the current standard of care where there could be kind of a bolus of already identified patients you could go after? Or should we be thinking about maybe a more gradual ramp as you need to get we And then my second question was just an update on CAR T capacity. Just walk through a little bit about how you're capacity to ramp as we move through 2022? And I guess when will you be in a position where capacity, I guess, is not the right limiting factor for the growth of these products? Thanks so much.

Speaker 8

Sure, Chris. I'll take both of those questions. With respect to MAVA and how we think about the shape of the opportunity, this launch will likely call, it's very much going to be in a stepwise fashion. We expect that there will be strong interest in treating the most severe patients, particularly in the centers of excellence where these Beyond this, we'll expand our focus to cardiology specialists and then to the broader cardiology community where uptake is just going to conference call will be more gradual. And one other thing I would say about as we think about really all of these segments, We have an educational effort on that will be initiated at launch as to how physicians should initiate and treat these patients.

Speaker 8

And certainly, there will be a focused effort to get patients compulated really is in line with the overall opportunity of $4,000,000,000 plus that we see for this asset. Moving to cell therapy Supply constraints. As we've said previously, the supply constraints that we're seeing right now are mainly related to Abecma. And our efforts are really focused on working with CMOs to accelerate capacity for Vector and then internally we're focused on flat capacity. And there are a number of things across Both of these efforts that we're focused on, including training and qualifying new staff, increasing our operational efficiency and increasing site capacity.

Speaker 8

On the Beqma, we would anticipate being in a much better position for supply as we get into the middle of this year. Conference. And then as it relates to Briansy, Briansy, the big focus there is on vector supply. It's something we continue to stay focused conference is on. And we fully expect to be in a position to support demand as we get later into this year and certainly by the time that we would

Operator

Bank of America.

Speaker 3

Good morning, guys. Thanks for taking the question. For some of the new launches, are there any metrics you guys conference can provide that show the wins and access and reimbursement, mostly talking about cell therapies and ZYPOSIO. The bigger picture is just trying to assess The tipping point for this year potentially for the launches collectively versus what we saw last year, which was a lot of lumpiness on kind of a sequential basis. And then the second question real quick on ducravasitinib.

Speaker 3

I know there's been a lot of angst about the potential for differentiating Labels versus JAKKS. And just want another way of clarity on the letter, just wanted to get maybe an updated view from you guys on that. Thank you.

Speaker 8

Sure. Maybe I'll start, Jeff. Thanks for the question. So as we look at access really across all of these launches, we feel very conference call, today's conference call. We've discussed the supply constraints, but The launches have gone off really without a hitch from a supply from a access standpoint.

Speaker 8

And in fact, if you look at the class of agents more generally, if you go back a couple of years, as you well know, access and reimbursement were significant areas of concerns. And I would say largely, conference? For the class of agents, we've been trending in the right direction, but we see no issues on our cell therapy assets. As we switch gears and you've mentioned ZAPOSIA, obviously, the focus is on UC, but very quickly on MS, feel very good about the access position there. We have very broad coverage in MS.

Speaker 8

Conference. So really not a significant concern on the MS side. In UC, we've been very clear that we have to execute a diligent symposia. Now how restricted from starter or bridge programs to commercial drug and do so very quickly for patients with more restricted access, which unsurprisingly for our 1st full year in the market, most patients have multiple step add heads. The focus is going to be on working through those restrictions and that's going to take more time.

Speaker 8

What I can say though in any case is that on Zposia, we're continuing to build volume over the course of this year. The plan has been and continues to be to then leverage that volume to move Zepozia into an earlier access position as we head into 2023, and we're very much on track to do that.

Speaker 6

And Jeff, I'll take on the question around ducralucitanib. So let me start by saying that we're obviously not going to speculate on the label conference call for what we have learned and the efficacy and the safety profile that we have talked about before and we are looking forward to the PDUFA date in September.

Speaker 5

Thanks

Operator

conference. Next, we'll go to Steve Scala with Cowen. Conference call is open.

Speaker 10

A couple of questions. Opdivo was a bit weak in Q4 similar to what we've seen from some of your competitors. Diagnoses still appear to be Are there any other reasons for weak oncology numbers? And what is the outlook for recovery? So or anyone else at Bristol No, the total number of stroke and bleeding events in the NOVEXAN stroke study to date, so both arms combined, not each one.

Speaker 10

And if yes, how are those total stroke and bleeding events trending to what you expected? Thank you.

Speaker 5

Conference call is being recorded.

Speaker 8

Maybe I'll start, Steve. With respect to let me just say at the outset, with respect to Opdivo, we're is very happy with the performance we saw for OPDIVO in the quarter. As David and Giovanni mentioned, we saw a return to growth for OPDIVO and actually saw an acceleration of Opdivo in the latter half of the year. As it relates to COVID, we have generally seen some improvement in a number of markets. But as you would imagine, the situation remains quite dynamic.

Speaker 8

As it relates to IO specifically, new patient volume conference has been gradually recovering, though I would say, where we sit today, we're roughly 5% to 10% academic versus community, but on net, it's about 5% to 10% below where we were pre COVID. Our hope in terms of the outlook is that we'll continue to see an improvement over the course of the year. If the pandemic has taught us anything, it's that we're going to have to continue to be flexible and agile. I can say definitively is that the impact will likely vary by product and market. From our standpoint, I think we've shown our business is resilient and our ability to grow really through the pandemic.

Speaker 8

And I think we've demonstrated an ability to execute. But sort of if you level it up, it's still a dynamic situation and one will watch carefully.

Speaker 6

And on the meloxicim trial, Steve, the The study is ongoing and we will not be talking about data, whether it's a pooled analysis or unblinded. We'll just have to wait for the data. And as I said earlier, we'll ending the data at the appropriate conference. Really looking forward to it though. Thank you.

Speaker 1

Thanks so much. Salaam, could we go to our next question please?

Speaker 5

Conference call is being recorded.

Operator

Next, we'll go to Chris Shibutani with Goldman Sachs.

Speaker 2

Maybe more medium to for the LAG-three combination fixed dose. Anything that you could share in terms of how you're thinking about positioning conference call is from Bempeg plus Opdivo, which I believe could be in the 2nd quarter timeframe. The economics are distinct there. However, help us at all with progress and timelines that would be appreciated. And then finally, on the IO, we see potential for the entry of lower cost checkpoint inhibitors, PD-one.

Speaker 2

Can you share with us your initial thoughts at this stage about how you see that influencing The market dynamics for checkpoint inhibitors and IL. Thank you.

Speaker 8

Sure. Maybe I'll start and I'll hit your first and third question. Conference call. We're very pleased with the opportunity to potentially launch rilatlimab. As we've said, if you look at the first line metastatic melanoma market, it's really divided into the thirds.

Speaker 8

You've got a third of patients who are treated with DUAL IO, that's Opdivo Plus, you're avoid that's a very strong position given the sustained OS benefit that we have with that population. You have about a third of patients who are treated with IO monotherapy, roughly split between Opdivo and KEYTRUDA fifty-fifty. Conference. And then you have a third of the market, which is really focused on targeted therapies. We see the opportunity for rolatlumab to really go after that third of the market, which is single agent PD-one therapy.

Speaker 8

We think that the data are very compelling relative to that population. Remember that rolatlumab is conference? 2 products in one vial. And so we think the opportunity to offer those patients dual IO therapy and a fixed dose combination offers a significant improvement over single agent monotherapy and that's going to be the initial focus at launch. As it relates to your question on low cost conference call in our larger markets like the U.

Speaker 8

S. Evidence continues to be the most important dimension choice, physicians want to see data in a specific tumor and patient type. And so there may be markets where these sort of low cost and E2 drugs are able to piggyback on innovation and drive use, but those historically have not been our larger markets. Obviously, things can evolve and we'll continue to monitor and adjust as necessary. But I think as a sort of put a Finer point on it.

Speaker 8

We shouldn't underestimate the barriers to sort of broad based commoditization in oncology, particularly for a product like Opdivo given the breadth of our data and indications.

Speaker 6

And Chris, on the Bempeg side, just as a reminder, there are 3 readouts that we anticipate this year, 1 in melanoma, 1 in renal cancer and 1 in bladder cancer. Conference call. The first suffrage, as you very well pointed out, is in melanoma. We are anticipating the data within the first half of this year. With that said, we are certainly very pleased you have 3 IO mechanisms already as in PD-one as well as CTLA-four and then anticipating the PDUFA and launch for the last.

Speaker 1

Thanks, Alan. Can we go to the next question, please? Conference call is being recorded.

Operator

Next, we'll go to Tim Anderson with Wolfe Research.

Speaker 11

Hi. Thanks conference call. This is Adam on behalf of Tim. On mavacamten, you've described this as being a $4,000,000,000 plus product by 2029. It seems that there are 2 main drivers of this, one of which is that the forecast assumes a tripling of diagnosis rates conference call is being recorded for OHCM going from about 25% today to 75% in the future.

Speaker 11

And the second is a mention of NH twofold. How realistic is it to expect a tripling of diagnosis rate? And second, what portion of

Speaker 8

conference call. So Adam, with respect to how we've thought about NAVA, first of all, conference. This is a market where we see a fairly well defined patient population. There are about 80,000 to 100,000 patients in the U. S.

Speaker 8

And roughly a comparable number conference call, we see significant unmet need for this patient population and the initial focus at launch is going to be focused on treating those patients who are symptomatic, Diagnosed and where there's a real urgency to treat. Now what we have said is that over the longer term with obstructive HCM, the focus will be on increasing the diagnosis rate. What we have said is that we plan on or we think it's feasible to double that diagnosis rate. It is currently, as you note, about 25%. And we think conference?

Speaker 8

With significant efforts, which we certainly have the skill set in the field to do, we think we can double that over time. So that's how we're looking at it. And in terms of the overall opportunity, the majority of the opportunity that we see is an obstructive disease. Conference. But certainly, we are looking forward to potentially seeing data in non obstructive as well.

Speaker 6

Yes. And on the AdCom question, conference We have not been notified of a potential AdCom. We do believe in the strong profile of mavacamten and benefit it provides in patients that we have enrolled conference is for trials for obstructive hypertrophic cardiomyopathy and we are now looking to launch, as you know, in April of 2022, as Chris said.

Speaker 1

Thanks so much. Our next question, please.

Operator

Yes, sir. Next, we'll go to Andrew Baum with Citi.

Speaker 2

Thank you. A couple of questions. So first on nilexin, I'm mindful the dose dependent interaction of aspirin with Plavix. You have a number of trials ongoing and completed looking at potential drug interactions with Norexion, perhaps you could comment on level of reassurance in terms of either interaction with ACCUPLACATE All commonly administered drugs in this patient population. And then second, you already highlighted the Q1 inflation in 20 2021 for Eliquis.

Speaker 2

Perhaps you could talk more generally to the trends, particularly for U. S. Eliquis growth for 2022.

Speaker 4

Conference

Speaker 6

call. So I will start off, Andrew. Thank you for your questions. And for melbixian, as you know that we have, 1st of all, the study ongoing already with antiplatelet agents in the SSP. So we'll get to see that data when that reads out.

Speaker 6

In terms of the other drug drug interaction studies, that is part and parcel of the usual clinical pharmacology package that we prepare in anticipation of future filings in NDA. At the current time, we do not see any major impact or anything major in terms of EDI. Yes.

Speaker 8

On the Eliquis questions, first of We're very happy with the performance that we saw with Eliquis obviously coming out of the Q4. And on this year, we expect continued strong growth for Eliquis. Eliquis is going to likely going to be the key driver of the overall OAC market. We're seeing a nice delta in share between our new to brand share and total brand share, which is roughly around 7% now, that gives us confidence in the near term growth trajectory. And we really do expect to see Eliquis in BRX and TRX share Xarelto.

Speaker 8

As it relates to the Zinc situation, we see no meaningful impact on revenue. There will impact on revenue. There are a few things to consider here. First, it's a relatively small part of our overall business. Conference call.

Speaker 8

You certainly won't lose all of the volume. What we know in this space is that there's significant risk for non medical switching of patients who are on Eliquis. Conference. We know also that downstream accounts, in light of that, many of them will not adhere to consistently that we're going to continue to be disciplined on gross to nets and how we manage those and this is part of that story.

Speaker 1

Thanks, Chris. Alan, could we go to the next question, please?

Operator

Conference is open. Next, we'll go to Ronny Gal with Bernstein.

Speaker 12

Good morning and thank you for taking my questions. First, just following up on Andrew's question. Can you talk a little bit about a benefit from 340 switch, especially from Aliquis? It seems to the net prices, Aliquis and 340 vehicles goes to nothing. And given the volume estimates that we are seeing, it should be a pretty good benefit for them this year.

Speaker 12

Can you talk about that? And second, Orencia, it seems to be growing together with the RA market. It seems to be in position to grow better given the JAK inhibitor safety issues.

Speaker 3

Can you talk a little bit about what

Speaker 12

you're seeing and what's your projection for 2022?

Speaker 8

Sure. Let me Yes. Giovanni, do you want to start?

Speaker 2

Go ahead, Chris.

Speaker 8

Conference call. Sure. So on 340B, let me just say at a macro level, we remain committed to ensuring the eligibility of patients for 3 40B, those patients who can directly benefit from the program. And what I would say, there's really no change in our stance with respect to 340B As it relates to the program, we're committed to it and we were committed to patients maintaining access to our medicines. And the change that we announced really was reflective of 2 things.

Speaker 8

1st, BMS and Celgene having different policies around the recognition of contract pharmacies and needing to align those as part of integration. And then second, wanting to ensure that the 340B discounts that we pay are valid and appropriate and we feel this change in policy And then, do you mind repeating your second question again?

Speaker 12

Great, if you can quantify

Speaker 6

conference call is from

Speaker 12

the JAK inhibitor's black box label.

Speaker 8

Sure. We're not going to comment on any impact of 340B. Again, I think we've given the rationale for having made that conference call change. As it relates to Orinzia, look, Orinzia continues to perform well in the RA market. The way we've thought about any potential change from a label update on JAK as it relates to RINCI or frankly any of our products is conference call.

Speaker 8

Those changes will likely continue to push JAKKS into labels are updated and their position of our products continues to execute against the strategy that we have and obviously will allow The situation with JAKs to evolve as they do.

Speaker 1

We go to our next question, please.

Operator

Certainly. Next, we'll go to Luisa Hector with Berenberg.

Speaker 13

Hello. Thank you for taking my questions. I wanted to conference call will discuss a little bit more on the 2022 outlook and the impact of Revlimid. So I just wondered if there are any particular risks you would highlight around the delivery conference call. And I guess really to confirm the pace of the revenue erosion is pretty predictable.

Speaker 13

So just checking on levels of uncertainty. How you are adapting to Revlimid The cost side of it. Thank you.

Speaker 4

Yes. Thanks for the question, Lisa. As we think About Revlimid, we thought it was important this year, number 1, to provide guidance on the full year. Conference call. And secondly, we thought it was really important to provide guidance on the quarter.

Speaker 4

And I'd say one thing is that conference? These are the contracts are annual volume limitation. So as the generics enter, it's all there could be quarter

Speaker 6

to quarter variability based upon how conference call is

Speaker 5

being recorded and we're looking at the market place.

Speaker 4

So that's why we thought it was important to provide that. The first generic entry is occurring in March. So there could be variability between the 1st and second quarter. And then conference call? The rest remainder of the generics will come usually about 180 days later is pretty typical in a generic entry scenario.

Speaker 4

So that would be in the September timeframe. But for the full year, we feel very confident in the guidance that we provided for the full year as it relates to Revlimid. As far as the expense base is concerned, I mean this is a really fortunate thing for us in the standpoint of you think about the 9 products that we're bringing to the marketplace, the 6 that are on the market and the 3 that we're launching this year, we're able to move resources within our therapeutic areas and reallocate the conference call, we're able to use existing resources to support those launch brands and our call space where we are. So and that's why we provide the guidance on operating expenses as we did.

Speaker 2

Maurizio, it's Giovanni. Let me just make David reference to Reglumid. Let me just say this is an important year for us because obviously, it's the 1st year. And what I'm really pleased of conference is the fact that we've got strong momentum with the line business. We are making great progress with the launch plans that are already on the market, we are looking forward to 3 important approvals.

Speaker 2

And this year, as you know, we've guided to growth both in terms of our revenue base, but also in terms of earnings per share. So I think that's a clear demonstration that we are confident in the ability to grow through the loss

Speaker 1

Thanks, Giovanni. Colin, could we go to the next question, please?

Operator

Conference call is open. Next, we'll go to Evan Seidman with BMO.

Speaker 6

Hey, guys. Thank you so much

Speaker 3

for taking my question. I'd like to Dive a

Speaker 6

little bit more on the IMPLIMID

Speaker 9

going generic. What do you need

Speaker 3

to show with these clinical trials to help maybe replace REVLIMID and POMALYD in

Speaker 2

the treatment landscape? And kind

Speaker 3

of how do you think about progressing those in clinical trials understanding that you have the standard of care with your current assets?

Speaker 2

Thank you.

Speaker 6

Sure. Thank you, Evan, for the question. From a Cellmod perspective, the way we are thinking about conference call and as we continue forward. We've generated the data in the late lines looking at a combination of iberdomide plus dexamethasone And CC480 plus dexamethasone. And we have early data in triplets as well looking at combinations with Velcade dexamethasone as well as CD38 antibodies and dexamethasone etcetera.

Speaker 6

As you will see later this year we are initiating a Phase 3 trial of Iberdomide plus Velcade plus dexamethasone comparing to the zone comparing to dexamethasone as well as Velcade and CD38 antibody. You will see in the short while coming up will be the Phase 3 trials of CC480 looking to replace pomalidomide and that would be a head to head comparatin versus thomaziramide combinations. And in 2022 sorry, 2023 and beyond, conference call, you will see trials of Iberdomide looking into the post transplant maintenance, head to head comparison versus Revlimid as well as the newly diagnosed patients who are transplant non eligible to again replace Revlimid the We are thinking about as we think about replacement of the current image. But let me also ask Chris to comment on the commercial perspective.

Speaker 8

Yes. I think you've covered most of it, Samad. Conference call is going to be important, as Samit noted, to generate data that differentiates directly from the Emmett's. There's obviously going to be a focus to address areas of Emmett unmet need, whether it's renal impairment or

Operator

conference is with Barclays.

Speaker 14

I wanted to focus a little bit on conference is the TI Immunology portfolio. Last year after the Phase 2 UC data sort of disappointing. You guys talked about an additional study and you see that's no longer sort of on your slides in terms of catalyst for 'twenty three the 'twenty two and 'twenty three. Just any Additional thoughts on that front and how you think about sort of being able to revisit UC and if we'll be able to get an answer to that question here in 2022. And then conference, maybe a little bit off the radar.

Speaker 14

Cindacumab, we've seen you sort of expand the development program there and then recently add sort of a Phase 3 study in conference call. Conference. Wanted to see if there were broader plans to run a pivotal study in the U. S. In that indication and maybe how some of the other competitor data in the recent history kind of maybe has shaped that viewpoint?

Speaker 14

Thank you.

Speaker 6

Both of those Phase 2 studies are ongoing. As we said earlier, that we do not have a proof of concept based on the first trial that we conducted with DUKLAVA. But there are 2 studies that are ongoing looking at a higher dose in UC in and the ongoing study. And when those data are available, we'll certainly be able to analyze those and take that program forward once we have a proof of concept. So it is not off the charts, but more about looking to generate the data to make decisions as we look forward.

Speaker 6

For cindacumab, the U. S. Study or the global study in eosinophilic Yes, this is already ongoing and enrolling patients as we speak. The Japan part is in addition to that as you have is already noted. So overall, the idea is to get that antibody to IL-thirteen into patients conference call with yeast mastoid acidophagitis and look for additional indications as you know that we have a study ongoing in atopic dermatitis as a Phase 2 conference call and that proof of concept can then generate additional indications for further development.

Speaker 1

Thanks, Alex. We go to our next question please, Alan.

Operator

Conference is open. Next, we'll go to Matt Phipps with William Blair.

Speaker 15

Good morning. Thanks for taking my questions. You all announced positive transform results in June a couple of weeks before a similar announcement from Yescarta. Yes, they have a PDUFA date in April and we're still kind of waiting on hearing the PDUFA date for Briansy. Are there any risks to meeting a 2022 approval milestone there?

Speaker 15

And then Summit, some 3 Phase 3s with

Speaker 6

Thanks, Dan, for the questions. On Briansy, as you know, we don't necessarily declare conference? Our filings until we have heard from the FDA from the acceptance perspective. So as time goes, we will certainly be able to share more in terms of the I'm very, very pleased with the data that we have as well as you know that BIANZI is a large development program. So additional trials are already ongoing in CLL follicular lymphoma conference call.

Speaker 6

As well as for additional indications in indolent NHL, we're certainly looking forward to launching the second line indication as as mentioned earlier during the call in that indication as well in the second line LBCM. For bempeg, certainly we as well as in renal cell and conference call is being recorded. As a reminder, these indications were chosen based on those Phase 2 data that we had seen early on, conference call, but each study stand on its own and the data will dictate how we proceed further in terms of future development.

Speaker 1

Can we go to the next question please?

Operator

Conference is answered. Next, we'll go to Matthew Harrison with Morgan Stanley.

Speaker 15

Hi. This is Charlie on for Matthew, total bleeding in the stroke prevention study? And second, can you provide more details regarding the ramps conference and what that will look like, patients need to be monitored. Conference call is being recorded. As you kind of walk through the early lines of therapy, can you talk about in terms of

Speaker 5

conference call is being

Speaker 6

recorded. I'll start off. So first of all, for meloxicillin in terms of what amount conference call? Bleed is acceptable. Look, it is all dependent.

Speaker 6

And certainly, we don't want to see any increase in bleed compared to the control arm. So that's how you conference call to compare and contrast. And we certainly have historical data from other therapies as well as how patients are treated today. So we'll have to put that into context conference. As we look at melvixion program, there are no numbers that I can share today with you as to how to start looking at or projecting out Those numbers.

Speaker 6

From the REMS perspective for mavacamten, once again, we are not going to get into specifics. But as we have spoken before, conference. What we are looking forward to is how patients are really managed in the clinic today. We have to go back to what Chris talked about earlier, the basic mechanism of the drug for mavacamten is myosin inhibition and we want to ensure that the patients are treated in a safe way So that we don't cause the heart to relax too much and decrease the ejection fraction. And that's the intent and the way the patients are currently managed on a continuous or ongoing basis is periodic echocardiographies.

Speaker 6

So more to follow on that as we get to the PDUFA date and final approval and full package of ransend and overall NDA approval. From an Abekma perspective, certainly the continuous progress in looking at the data conference call is from Karma and then Karma 3 and Karma 2 proof of concept this year conference will dictate the further evolution in terms of the overall development program and studies are going to be as important as commercialization. Conference call. So certainly from a supply perspective, Chris, can you

Speaker 8

make one comment on the REMS? The way that we have approached the RIMs, obviously, we knew a RIMs would likely would be likely with this asset. We conference call is being recorded. We've worked very closely from a commercial standpoint with Summit's team to ensure that the nature of that REM fits very nicely into how physicians conference call will be available to treat patients

Speaker 6

in particular challenges associated with that as

Speaker 8

we go into the launch. And conference call is being recorded. I think Samit's last point is particularly relevant as it relates to Abekma, which is that the way we've approached Looking at clinical and commercial supply is that obviously commercial supply is critically important, but it is equally important that we continue to prosecute our development program and we're going to continue to make those trade offs With both of those priorities

Speaker 1

in mind. Thanks, Chris. Can we go to the next question, please, Alan?

Speaker 6

Conference call is on

Speaker 3

mavacamten. We've seen biomarker data from Mavriq ability of developing and non obstructive and half past. When do you think the team would be able to outline conference call have some emergent data from the DragonFly collaboration on IL-twelve call that the oncology community seems to be pretty excited about. Thank you.

Speaker 6

Sure. I can take looking forward to initiating the first Phase 3 study in non obstructive hypertrophic cardiomyopathy is within 2022. And conference call will be recorded

Speaker 15

over time and then that

Speaker 6

will dictate the future development Phase 3 as well. For Dragonfly, once again, it's an early phase development right now in Phase 1, looking at conference call is a single and then combination as well. So, as that data evolves, which we conference call is available on the call. And those will be presented at appropriate conferences as we look to the future.

Speaker 1

Conference call. I think we can maybe go to our last question please, Alan.

Operator

Conference call. Our last question will be from Mohit Bansal with Wells Fargo Securities.

Speaker 3

Hey, good morning. This is James on for Mohit. Just a couple of quick questions. For DUKAVA, I know there's 4 new doses, but will you be rerunning the lab safety analysis conference call to differentiate or rule out any jack like signals? And then for the S-1Ps, how is BMI or BMI expecting The SMPs

Speaker 2

to be positioned relative to

Speaker 3

the JAKKS. And any thoughts on competitiveness of Zekovia relative to etrasimod?

Speaker 6

Conference call. So let me start with ducaracitinib. So we've already got 2 Phase 3 studies that have read out follow-up. So those are all in line with the safety profiles that we have added. So we certainly do not look forward to doing additional conference call will continue and see additional evolution.

Speaker 6

And certainly those similar sorts of exercises of continuing to generate data at higher doses for other indications that we are studying will be evaluated when data are available. From an SLMD perspective, Chris, do you Sure.

Speaker 8

I'll take that one. So James, as I said earlier, we do expect that there's going to continue to be an evolution conference call, that could continue to push those assets into later lines of From our perspective, we continue to be very happy with the profile is Zposia, both from an efficacy given the strong clinical remissions as well as the clean safety profile. Our focus continues to be drive awareness and overall volume. There may be opportunities longer term given we do in order to build volume. And with respect to differentiation against other conference?

Speaker 8

Future S1Ps in that space. Again, I would just say that we're very confident in the

Speaker 6

conference call. Thanks, everyone, and I appreciate that. I'll close by saying conference call

Speaker 2

was really pleased with our performance in the quarter. And much more broadly, our performance in 20 2021 positions us really well to deliver growth this year in 2022 and beyond. We have built a solid foundation, and I'm confident that as our portfolio renewal gains traction this year, conference call, our company is well positioned to reach new heights, both for patients and shareholders. And I want to thank our Thanks for being with us for the call. Our team remains available to answer any additional questions

Operator

concludes today's conference. We thank everyone again for their participation.

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Earnings Conference Call
Bristol-Myers Squibb Q4 2021
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