Bristol-Myers Squibb Q2 2022 Earnings Call Transcript

Quartr
Provided by Quartr
July 26, 2022

There are 21 speakers on the call.

Operator

Good day, and welcome to the Bristol Myers Squibb Second Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

Speaker 1

Thanks, Sarah, and good morning, everyone. Thanks for joining us this morning for our Q2 2022 Earnings Call. I'm joined this morning with prepared remarks by Giovanni Cafforio, our Board Chair and Chief Executive Officer and by David Elkins, our Chief Financial Officer. And also taking part in today's call are Chris Berner, our Chief Commercialization Officer and Sumit Harawat, our Chief Medical Officer and Head of Global Drug Development. You'll note that we posted slides to bms.com that you can use to follow along with for Giovanni and David's remarks.

Speaker 1

But before we get started, 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 company's SEC filings. These forward looking statements represent our estimates as of today and should be not 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.

Speaker 1

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 financial measures to most comparable GAAP measures are available at bms.com. And I'll hand it over now to Giovanni.

Speaker 2

Thank you, Tim, and good morning, everyone. Let's start with our Q2 performance on Slide 4. We are midway through 2022 and we've made Great progress during an important year for the company. We continued to grow our in line franchises, expand our new product portfolio, Advance our pipeline and execute important business development activities. Our foundation is strong and positions us well for growth.

Speaker 2

With respect to our commercial performance, we delivered continued sales growth with revenue up 5% adjusting for foreign exchange and non GAAP EPS increasing by 18%. The strong revenue growth was driven by excellent commercial execution with solid year over year growth For our in line brands, particularly for Eliquis and our IO franchise and significant momentum from our new product portfolio. Within our new product portfolio, Obdualag, our 3rd IO agent is off to a great start And we are pleased with the team's early execution. OPDALAG strengthens our position in IO and accelerates the sustainability and growth of our IO franchise. We are also establishing a strong foundation for Kamsaios.

Speaker 2

As the first agent that effectively treats The underlying condition of symptomatic obstructive HCM, we see a lot of potential to drive significant penetration in this large, Underserved and Underdiagnosed population. We also made great progress advancing our broad set of pipeline opportunities through regulatory approvals and clinical trial readouts during the quarter. In hematology, we received U. S. FDA approval for Briansy With a best in class label in second line large B cell lymphoma as well as EMA validation.

Speaker 2

With this approval, Briansi now has the broadest patient eligibility of any CAR T cell therapy in relapsed or refractory LBCL. This reinforces our opportunity for leadership in cell therapy and further strengthens our view of Brienzi as a key growth driver for the company with over $3,000,000,000 in non risk adjusted revenue potential in 2029. In cardiovascular, We delivered positive Phase 2 data for Milvexion in secondary stroke prevention, and we're looking forward to this data being presented at the European Society of Cardiology Meeting next month. With this data in hand, we plan to initiate our Phase 3 program by the end of the year, which provides an important opportunity to improve outcomes for patients and extend our world leading antithrombotic business into the next decade. And in oncology, we continue to strengthen the growth outlook for Opdivo with another indication in GI cancers, where it now has a leading position.

Speaker 2

During the quarter, our financial results were strong with growth In our in line and new product businesses, our financial strength continues to provide us with significant flexibility to deploy capital In a balanced way, including for business development. And during the quarter, we announced an agreement to acquire Turning Point Therapeutics, a leading precision oncology company. On Slide 5, let's discuss Turning Point's lead asset, ripofrectinib, which is a next generation potential best in class TKI targeting the ROS and nFREQ driver mutations of non small cell lung cancer and Advanced Solid Tumors. Importantly, as you can see on the slide, the key first line lung cancer data that has been announced for reprotectinib is differentiated from potential competitors on duration of response and safety profile. This acquisition will broaden our portfolio in precision and in solid tumors and it is a strategic fit for the company.

Speaker 2

We expect the transaction to close in the Q3 of this year and believe it will support our medium to long term growth strategy with accretion to non GAAP EPS beginning in 2025. We plan to continue to leverage our financial strength to pursue transformational science through business development. Turning to our execution scorecard on Slide 6. We know the importance of continued delivery of key pipeline milestones And we have made tremendous progress across therapeutic areas this year. In addition to the key milestones I already mentioned for Brianca and Nildexan, We have reached mid to late stage pipeline and we are accelerating the next generation of potential medicines.

Speaker 2

Over time, we believe iberdomide and CC480 or mezizdomide have the potential to play an important role in multiple myeloma. In that regard, we made good progress during the quarter, Having moved Iberdomide into its 1st registrational trial in the second line setting of multiple myeloma. Looking ahead, I am encouraged by the breadth of opportunities for the rest of this year and beyond. We look forward to the PDUFA date ducravacitanib in psoriasis in September. We're excited for the opportunity to bring this oral of choice medicine to moderate to severe psoriasis patients soon.

Speaker 2

With multiple indications on the horizon beyond psoriasis, we believe that this asset has greater than $4,000,000,000 in non risk adjusted revenue potential in 2029. In addition, we also expect to see data to support important expansion opportunities for other key medicines over time. These include key data for Abecma, Opdivo, Opdolag and Revlazone. We hope that this data will enable these medicines to benefit more patients and further expand their commercial potential. I remain excited about the multiple opportunities we have across our pipeline, and I look forward to continuing to update you on our progress.

Speaker 2

As I review our performance during the first half of twenty twenty two, I'm very proud of the employees of Bristol Myers Squibb 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 4 key therapeutic areas. Our performance in the quarter continues to demonstrate the resiliency of our business and our continued financial strength. We believe this positions us well to continue to grow our business in an increasingly complex External environment. This includes macroeconomic factors such as the strengthening U.

Speaker 2

S. Dollar and accelerating inflation as well as Legislative headwinds in the U. S. Given our growing and rapidly diversifying business and our continued financial flexibility, We remain very well positioned for the future. With that, I'll turn it over to David to walk you through the financials in detail.

Speaker 2

David?

Speaker 3

Thank you, Giovanni, and thanks again for all of you joining our Q2 earnings call. Let's turn to Slide 8 to discuss our solid top line performance. Unless otherwise stated, I will discuss our sales performance growth rates on an underlying basis, which excludes the impact of foreign exchange. 2nd quarter revenues were approximately $11,900,000,000 growing 5% year over year. This performance was driven by robust growth of our in line and new product portfolio of 16%, more than offsetting our recent LOEs.

Speaker 3

Let's now double click on our new product portfolio performance on Slide 9. Global revenues were nearly $500,000,000 more than doubling revenue versus prior year. Growth over prior quarter was also very strong, up 38%, primarily due to strong launches of APECMA and Opdulag, which I will touch on in a moment. I'm very pleased with the performance of our new product portfolio and its future potential. With 2 additional launches year to date and ducravasitinib's anticipated approval in 6 weeks, our new product portfolio has significant expansion opportunities I look forward to updating you on these products as they continue to realize their full potential.

Speaker 3

The performance of our solid tumor portfolio shown on Slide 10 was strong. Opdivo sales in the quarter continue to grow globally, driven by demand for our newly launched end core indications. In the U. S, we delivered 12% growth for Opdivo versus prior year, driven by demand in first line lung, renal and gastric cancer, as well as adjuvant esophageal and bladder cancers, partially offset by some OptiLag in first line melanoma. Internationally, revenues were also strong growing 13% primarily due to growth from new indications, particularly first line lung and renal cancers, as we continue to secure reimbursement in many countries.

Speaker 3

Looking forward, we expect continued growth from Opdivo from our new and expanding indications Both early and late stage cancers. Year over voice sales grew 7% globally. And in the U. S, revenues were consistent with prior year we experienced some variability in RCC and melanoma as well as higher inventory burn and gross to net adjustments this year. Importantly, sequential revenues grew 5%, primarily driven by demand in first line lung cancer, and we continue to expect growth for the brand.

Speaker 3

Now to our strong launch of Optilag, the 1st fixed dose combination of the LAG-three and PD-one inhibitor. While still early in the launch, we have already generated $58,000,000 of sales in Quarter, driven primarily by robust demand and $10,000,000 of stocking. The robust demand for OptoLayc has mainly been in line with our strategy, Taking share from PD-one monotherapy and as expected some use in place of OPDIVOY combination. Internationally, we are pleased with the recent CHMP Positive opinion in Europe and look forward to realizing Optylyze potential to be a new standard of care in patients with metastatic melanoma around the world. Turning to our growing cardiovascular portfolio on Slide 11, starting with Eliquis, our leading OX globally with strong revenue growth of 20% year over year.

Speaker 3

In the U. S, sales increased 27% versus prior year, driven primarily by demand growth and favorable gross to net adjustments. As a reminder, looking to the 3rd and 4th quarters, we expect the usual dynamics for Medicare coverage gap with second half revenues being lower than first half as we've seen in previous years. Internationally, sales grew 9% versus a year ago. This growth was primarily driven by increased share across key markets As the brand continues to be the number one OAC in multiple countries, this was partially offset by pricing actions in many markets as demand grows and to a smaller extent at risk generic launch in the UK and the Netherlands.

Speaker 3

For the second half of the year, we expect the impact of at risk generic launch to be about $250,000,000 Now turning to our most recent launch, KEMZYOS. As you know, the vast majority of patients initiating treatment on KEMZYOS are starting on a free trial offer for at least 30 days. And then the $3,000,000 recorded in revenue in the quarter was mainly due to stocking. During the Q2, we have successfully laid the foundation, leveraging our strong CV leadership in REMS to certify over 1,000 healthcare professionals. We are now focused on broadening our user base and supporting the initiation of patients on KANZYUS.

Speaker 3

We are pleased with the physician feedback thus far and look forward to helping more patients living with symptomatic OHCM. Moving on to a few of our hematology products on Slide 12, starting with REVLIMID. Sales in the quarter were approximately $2,500,000,000 Sales were primarily impacted by generic entry, particularly in international markets. In the U. S, while we did experience demand softness from the volume limited generic entry in the quarter, we understand that specialty These are mainly utilizing the current generic for new patients to ensure continuity of treatment.

Speaker 3

As mentioned in the past, we know there will be variability quarter Quarter based on how generics will deploy their volume. As additional entrants will be coming to the market in the U. S. In the 3rd quarter, We expect Q3 revenues to be approximately $2,100,000,000 We maintain our full year global sales guidance of $9,000,000,000 to $9,500,000,000 PAMELA's global revenues grew 9% versus prior year, primarily driven by demand for triplet based regimens in earlier lines and extending duration of treatment. Now moving to Revlissel, which generated $172,000,000 in the quarter, up a strong 36% versus prior year.

Speaker 3

In the U. S, we're seeing encouraging trends in patient adherence and extended treatment duration. Outside of the U. S, REBLISEL continues driven by demand in both MDS and beta thalassemia associated anemia and as we retain reimbursement in additional countries. Finally, turning to our cell therapy assets, Beqma and Brianca.

Speaker 3

Beqma generated strong revenues in the quarter equaling $89,000,000 This represents a 36% sequential increase over last quarter, driven by expanded capacity and vector supply. Though we encourage to treat more multiple myeloma patients, demand continues to outpace supply and we are focused on further expanding capacity, including additional manufacturing sites in the future. As it relates to Breanzi, sales in the quarter were $39,000,000 Demand remains strong for the brand, although sales were impacted by lower than expected manufacturing success rates, which now have been addressed. Importantly, as Giovanni mentioned, we are very pleased to have received a differentiated broad second line label in large B cell lymphoma patients. We are working hard and investing to expand capacity early next year to enable uptake for this indication.

Speaker 3

As we work Through building additional capacity to treat more patients in earlier lines, we expect revenues in the 3rd and 4th quarters to be largely similar to the Q1 of this year. Moving on to our immunology product summary on Slide 13. Orencia global sales grew 11% versus prior year due to expanded U. S. Sales driven by increased market share as well as demand in international markets.

Speaker 3

Turning to ZYPOSIA. Global sales for the quarter were $66,000,000 More than doubling sales versus last year, primarily due to expansion of ZYPOSIA into ulcerative colitis. Sequentially in the U. S, Sales were primarily driven by a combination of favorable gross to net and wholesale buying patterns of approximately $20,000,000 Importantly,

Speaker 2

we

Speaker 3

are encouraged by the 24% demand growth over the previous quarter and remain focused on working to further expand volume, so we can continue to improve access in 2023. Internationally, ZAPOSIA continues to secure reimbursement in other markets for MS and UC. Closing out on immunology, we very much look forward to broadening our portfolio with another first in class asset, our selective TYK2 inhibitor To travacitinib, our commercial and medical teams are in place and we're ready for launch. Now let's turn to Slide 14 to discuss the Q2 P and L. I've already discussed our revenues, so I'll now focus on the other key line item non GAAP line items.

Speaker 3

Gross margins decreased primarily due to product mix, partially offset by foreign exchange and related hedging settlements. Our operating expenses excluding acquired in process R and D were broadly in line with prior year, driven by higher investments around our new product portfolio and pipeline offset primarily by foreign exchange. Acquired In process R and D charges in the quarter were $400,000,000 primarily driven by the buyout of a royalty obligation for KANZYUS of $295,000,000 as well as a $90,000,000 upfront for BridgeBio. This accounted for a 17% impact to diluted EPS. Acquired in process R and D charges in the prior year were approximately $793,000,000 which accounted for a $0.30 impact to diluted EPS.

Speaker 3

The 2nd quarter tax rate was impacted by earnings mix. And lastly, we delivered strong non GAAP EPS growth in the quarter, up 18% year over year. This includes the $0.14 impact of acquired in process R and D. Excluding acquired In Process R and D non GAAP EPS would have grown 7%. Now moving to the balance sheet and capital allocation on Slide 15.

Speaker 3

The company's balance sheet remains strong with $13,200,000,000 in cash and marketable securities on hand as of June 30. Cash flow from operations in the first half of the year was $6,100,000,000 In the quarter, it was approximately $2,300,000,000 which is impacted by a cash tax statement and we expect cash flow from operations to rebound in Q3 and Q4. Our capital allocation priorities remain unchanged. Business development continues to be a top priority and we continue to execute on this priority with the announcement of the planned acquisition of Turning Point Therapeutics. We remain committed to continued debt reduction.

Speaker 3

In the quarter, we repaid $2,900,000,000 of debt, And we remain committed to returning capital to shareholders. We executed a $5,000,000,000 ASR earlier this year and remain opportunistic about repurchases in the future. Now turning to our 2022 non GAAP guidance on Slide 16. We're updating our revenue guidance to be approximately $46,000,000,000 this year, reflecting the significant appreciation of the U. S.

Speaker 3

Dollar to other global currencies. Excluding the effects of currency, the underlying sales growth for the business is expected to be 2% versus 2021. We estimate the FX impact to full year sales at today's spot rate to be about $1,500,000,000 We continue to expect our in line and new product portfolio to grow in the low double digit range and reaffirm our LOE guidance, including Revlimid's guidance of $9,000,000,000 to $9,500,000,000 for the year. Gross margin is expected to be approximately 79%, up 100 basis points from previous guidance due to favorable impact of currency and related hedging settlements. Our operating expense guidance excluding Acquired in process R and D remained unchanged, declining in the low single digits versus prior year.

Speaker 3

This is primarily driven by favorability in FX As well as cost discipline, in terms of phasing for the second half of the year, we expect a more even phasing of expenses than in prior years. All said, we are reaffirming our non GAAP adjusted EPS guidance based on the underlying strength of our portfolio, Mitigating currency translation from our natural hedges and hedging program. Before we move to Q and A, I just want to express my gratitude to all our colleagues around the world continuing to deliver strong commercial, clinical and financial results. The resiliency of our company and exciting catalysts ahead Make me energized by the growth opportunity ahead of us. I'll now turn the call back over to Tim and Giovanni for Q and A.

Speaker 1

Thanks, David. Sarah, could we go to our first question, please?

Operator

Thank And we'll take our first caller from Chris Shubhutani with Goldman Sachs.

Speaker 4

Hi, this is Dan on for Chris. Thanks for taking our question. 2 from us. First on the mill vaccine readout, if you could Maybe frame some areas of focus into the ESC data and provide any additional color into how you're thinking about the Phase 3 program now that the data is in house. And then second on Kamsios, if there's any additional feedback you can provide on some of the early launch dynamics and your expectations into the second half of the year and early next year.

Speaker 4

Thank you.

Speaker 2

Thank you, Dan. Samit will answer your question on Milvixion and Chris provide some incremental color on KANZYOS. Thanks.

Speaker 5

Sure. Thank you, Giovanni, and thank you, Dan, for the question, Vyxe. I'm certainly looking forward to having the data presented at VSC and discussing The results and of course, I as you know, we'll go into the details about the specifics of the data itself. But I think there are 2 questions that Probably are important to answer, then we look at the data and that would be one related to Specifically, when it comes to impact on clinically proven ischemic strokes. And the second, of course, is to look at bleeding rates and more specifically over there, one that Physicians and patients would be interested to know about would be probably related to intracranial bleeds where patients with strokes have a propensity to have bleed as well as if there are any fatal bleeds.

Speaker 5

And so those are the kinds of Questions that we set out to answer and I think those are the questions that people will be very interested to know. Before Kim Dyer, let me pass it on to Chris, I could take you through.

Speaker 6

Thanks, Amit, and thanks, Dan, for the question. We are very pleased with the early launch of Cam Zios, while it's still very early days, we're off to a very good start. And what I would say is that by and large, the performance that we're seeing is aligned to our And I would highlight maybe 2 or 3 things. First, awareness is very good. We've seen incredibly strong enthusiasm for the product From both physicians and patients.

Speaker 6

Importantly, the feedback that we're getting on the clinical program has been overwhelmingly positive and consistent. To give you some vignette on that, patients are seeing significant benefit both in terms of feel and function And that benefit is being seen very early, in fact, as early as 4 weeks post initiating treatment. And that's really important because it's driven a lot of enthusiasm both from patients and it's given physicians a reason to believe that the product is living up to the promise that we have. In terms of physician experience, the feedback has been very positive. The RIMS education that we've initiated is intuitive, getting on And certified for REMS has been straightforward.

Speaker 6

And as David mentioned, that's translated to over 1400 HCPs being REMS certified. And one thing I would highlight is that this is probably the most important leading indicator for this product launch. Given the fact that you don't have a history of RIMs In the cardiovascular space, physicians are going to be REM certified if they have intent to use. And the last thing I would highlight is we're seeing a healthy increase in the number of centers Prescribing week over week, we don't see any access issues on the horizon that would prevent these patients who are getting on to therapy converting to drug. And so if I sum it up, performance is in line with expectations.

Speaker 6

We're happy with what we're seeing and we very much look forward to the continued uptake of this product over the course of the year.

Speaker 7

Great. Thanks,

Speaker 1

Chris. Sarah, can we go to the next question, please?

Operator

Thank you. Next, we'll take Andrew Baum with Citi.

Speaker 8

Thank you. First question on LOREXIN. Is there any possibility you could expedite what's going to be a very large Long duration clinical trial program through the adoption of MRI defined silent strokes within a composite endpoint, Either to expedite the trial or to decrease the end required for the trials. 2nd, could you comment on whether you are exploring Your CD19 CV3 your CD19 CAR T, excuse me, Briamdi for autoimmune indications given some of the recent data in lupus. And then finally, one of your competitors announced some intriguing data with the MACIOS slated CTLA-four in MSS colorectal cancer.

Speaker 8

I know that Bristol has 1 in, I think, Phase 2. If you could provide us any update on that, that would be useful. Many thanks.

Speaker 2

Thank you, Andrew. I'll ask Samit to answer your three questions.

Speaker 5

Yes. Thank you, Johnny, and thank you, Andrew. Very thoughtful questions As always, for Melvix, we're not obviously going to get into the Phase 3 indications right now. But from a Phase 2 perspective, you will certainly get to see the data and what is important is from a physician's perspective, what matters really is The clinical strokes and those certainly will be the questions to discuss when the data are presented. On the CD19 side, certainly very Seeding data in the autoimmune disease, especially in the SLE phase, SLE patients who are severely impacted by the disease.

Speaker 5

Those are the things that we continue to discuss from a scientific perspective, how to explore, where to explore and certainly not hidden from us. And as we evolve in our thinking, We'll share with everyone where we are going with that. The German data were very intriguing, I have to say, and as were presented earlier this year. For CTLA-four, we've seen the data on CRC from a competitor. From our perspective, we have She circulated 4 antibodies in development, the non precursulated probody as well as the non precursuated probody.

Speaker 5

So there are 3 that are in development. The way we think about it is number 1, we have an ongoing study in MSS CRC for that you know that we just initiated with Opio LAG Comparing to the standard of care and for future developments for CTLA-four antibodies, we have to think about combination strategies because we know that many In the past, when single agents have been used, the response rates ultimately in registration trials have really been single digit or low single digits in fact. So we will obviously be able to share the data once we have these combination studies completed. They are currently ongoing. Too early to talk about the data at this time, but certainly aware of the CRC data.

Speaker 1

Thank you, Samit. Sir, can we go to the next one, please?

Operator

We'll take our next question from Geoff Meacham with Bank of America.

Speaker 9

Hey, guys. Thanks so much for the questions. Had a commercial one and a pipeline one. Chris, on roblozil, can you talk about the U. S.

Speaker 9

Trends? What does duration of therapy look like today Versus say a year ago and does demand support upside to your peak forecast? And then Samit or Giovanni, I know Turning Point hasn't closed yet, but how much of a focus is IO plus targeted therapy For Bristol, looking forward, I know ROS1 combos are probably more likely than not to come to play out in the pipeline. But Beyond that, do you guys see this as sort of a new type of modality to sort of bolt on to an IO, IO strategy? Thank you.

Speaker 2

Thank you, Jeff. Chris, why don't you start on roblozil and then Samit will comment on Oncology Strategy.

Speaker 6

Yes. Thanks for the question, Jeff. We're very pleased with the continued update that we're seeing with REBRISIL. We had Good growth in the quarter versus prior year as well as sequentially. I would highlight a few things.

Speaker 6

First, we're continuing to see good acquisition of new patients for this product. One of the things that we look very carefully at is what are physicians' perceptions of the product and importantly how quickly they're moving patients off of ESAs to Get on to REBLAZYL therapy, that time on ESAs when patients are not getting an adequate response continues to shorten, which is a leading indicator of the number of patients that will be within the indication that we have. And importantly, we're seeing nice trends in both dosing and administration. The average MDS dose by cycle has grown steadily during the course of this launch and has increased this year. That's resulted in improved efficacy and longer duration of therapy, which to your question has been up 6% this year relative to where we were in 2021.

Speaker 6

And while your question was mainly focused, I think, on the U. S, I would highlight that ex U. S, the launch is early, but we're seeing very good uptake In the early launch markets, notably markets like Germany, and then we'll have additional access and reimbursement decisions ex U. S. So overall, We feel very good about where we are and we look forward to continued uptake of this product as we go through the remainder of the year.

Speaker 5

And thanks, Chris and Jeff. Maybe I can take on the Turning Point question. So first of all, excited about the acquisition of Turning Point Therapeutics And looking forward to bringing repotrectinib to patients in the second half of next year. Your question around the combinations, those are all going to be Always data dependent and so explorations will continue. Although at this time, certainly there is Lots of emergence of data of TKI combinations or tyrosine kinase inhibitors, which are not necessarily mutation specific tyrosine kinases, which have generated a lot of interest and a lot of data and have been approved in multiple indications when combined with IO therapies, But it does provide additional opportunities in the future to look at these sorts of combinations and more specific pre specified populations and selected patient populations, but those will be data that will need to be generated at the current time too early to tell.

Speaker 1

Thank you, Samit. Great. Sarah, can we go to the next question, please?

Operator

Thank you. We'll take our next question from Chris Scott with JPMorgan.

Speaker 10

Great. Thanks so much for the questions. I guess first one for me was on Briansy In terms of what's the latest on maybe the timing and maybe as importantly the magnitude of your capacity expansion, it sounds like this might have been getting pushed out 2023 versus I think previously you were talking about maybe a 4Q target. I just wanted to elaborate a bit more on what's happening there. And then my second question was on KYMZYOS.

Speaker 10

I know there's

Speaker 9

But as we just kind of

Speaker 10

think about the sales ramp from here, should we be thinking about this as a fairly gradual process? Or is this a product that could see A steeper ramp starting sometime later this year given that there are some identified kind of patients out there. I'm just trying to see in terms of expectation setting of how to think about the ramp given some of the, I guess, the promising initial data in terms of the number of physicians getting certified, etcetera? Thank you.

Speaker 2

Thank you, Chris. Chris?

Speaker 6

Thanks for the question, Chris. On Briyansy, what I would say just at the outset around cell therapy in general is that the Demand in the quarter for both of these products, Abecna and Briyonzi, was strong. We continue to be very pleased with the feedback on the profiles of these products and importantly, how those Profiles position us competitively. With respect to Brianca, as David mentioned earlier, we had underlying demand that was very strong. We're obviously very With the second line approval and the fact that it's given us the broadest label of any CAR T in DLBCL.

Speaker 6

But as David also mentioned, sales were impacted in the quarter by manufacturing success rates. Those success rates, the issue underlying that was resolved and we expect to improve as we head into this quarter. More generally around manufacturing with Breanzi, given the broader label, we had obviously hoped to have increased Capacity in the second half of this year, we're now anticipating that in Q1 of 2023. Delivering that capacity is a top priority. The focus here is on increasing both vector and drug product supply.

Speaker 6

I will note that we've seen a nice increase In the capacity for Beqma driven by successful drug product expansion and increasing in vector supply, and we anticipate That, that same focus will be now applied, to Briansy and have every expectation that we'll be able to deliver on that. That capacity is going to be important Because given the broad label with this product and the compelling profile, slot availability is going to be critical. So, the The good news is we have a very strong manufacturing team focused on increasing the supply and we look forward to delivering that supply in the 1st part of the year. As for Kymzyos and the pace of launch, I would view this as a steady increase in the number of patients. There are going to be 4 things that are really going to determine the pace of this launch: Physician and patient demand, the volume of REM certified physicians, how quickly those patients Come to get on Kamsiotherapy and then obviously the conversion of those patients to commercial drug.

Speaker 6

And I would say really across all of those dimensions, We're happy with what we're seeing. As I referenced earlier, it's in line with where we expect it to be this early in the launch. As I mentioned earlier, the demand for the product is very strong. We're getting great feedback from both patients and physicians. I spoke to the volume of users and the fact that We're seeing a nice increase in the number of REMS certified physicians every week.

Speaker 6

We had told you previously, I think in fact last quarter, That we expected patients to initiate therapy during their routine visits and that's largely playing out. Though I would say We've seen a number of accounts, including some of our smaller and medium sized accounts quickly getting multiple patients on the drug. We're also seeing some of our larger accounts organizing CAMZIO's clinic days so that they can efficiently bring larger volumes Patients initiate them and monitor them. So again, that's where we thought it would be. And then finally, as I referenced earlier, access is going to be And consideration here, virtually all oral specialty products like Kamsaios go through this period of 2 to 6 months Of getting on to formulary during that period, the majority of patients are going to go on to free product.

Speaker 6

That's what we're seeing here. But again, the good news is we're not seeing any access issues. So we don't foresee any challenges converting those patients to commercial drug. So when you add it up, we expect the volume is going to increase over the course of the year and then you'll see those patients convert to commercial sales As formulary status is achieved. But bottom line, we're very happy with what we're seeing thus far, very much in line with expectations.

Speaker 1

Thanks, Chris. Sir, can we go to the next question, please?

Operator

Thank you. We'll take our next caller from Steve Scala with Cowen.

Speaker 11

Well, thank you very much. Couple for Samit. First, in your dukarvasitanib FDA discussions to date, Has there been any mention of a box warning whatsoever or has that not come up in any conversation? And also given the timeframe involved, can we assume there won't be an ADCOM? And then the second question is based on available data, Does Bristol think other cardiac myosin inhibitors will have a black box warning or do you think they could avoid that?

Speaker 11

Thank you.

Speaker 2

Thank you, Steve. Before I ask Samit to answer both of your questions, let me just say, as you know, we don't comment on ongoing Discussion with regulatory authorities, but Samit will provide his perspective on both. Samit?

Speaker 5

Yes. Thank you. Steve, As Giovanni already mentioned, no specifics to be provided here. What I can repeat, I think from the past conversations we've had Is our confidence in the data itself for DUCRALA sickness and we think about from an efficacy perspective, differentiation and superiority that has been proven through the Phase 3 trial versus OTEZLA from a safety perspective showing differentiation when we think about the JAK inhibitors versus duplicitinib And this is that profile that has continued to evolve through multiple other trials that has given us other confidence to initiate the programs as you know psoriatic arthritis, 2 Phase 3 trials ongoing and also now looking forward to initiation of the SLE Phase 3 trials at the end of the year beginning of next year. So overall, we're looking forward to September 10 PDUFA date and bringing this new medicine to patients.

Speaker 5

In a similar way, I would say in the Cardiac myosin inhibitors, it is difficult and not appropriate probably for us to comment on other people's drug as to what the Profile is going to look like and if they will have any warnings and precautions in the label or not. What we can say though is again a belief in KEMZYO says Already alluded to by Chris as well and David in his remarks, our belief in the data and how physicians are acting In terms of getting trained and prescribing it to the patients. So overall, looking forward to initiation of our Non obstructive hypertrophy cardiomyopathy Phase 3 program towards the end of the year. Thank you.

Operator

Thank you.

Speaker 12

Can we

Speaker 1

go to the next question please?

Operator

Yes. We'll go on to Seamus Fernandez with Guggenheim.

Speaker 13

Thanks for the question. So just a couple of quick questions. First off, This is really for Giovanni. Should Congress pass the Medicare pricing reform, can you just help us understand what impacts You think this is likely to have whether it be on innovation, but also on your own long term guidance from that perspective? And Are you hopeful that there might be, should this go through, potential changes that could temper The impact perhaps a push out of this small molecule argument of 9 years of protection And perhaps maybe push that out to 12 or 13 years.

Speaker 13

Just wondering if there are any opportunities to think a little bit more constructively about this. And then separately, hoping to just get a little bit of color on the launch Dynamics around ducravasitinib, you guys are commenting on your enthusiasm to kind of get this product to market and to patients.

Speaker 1

Just wanted to get a

Speaker 13

better sense of should the label actually have a jack Boxed Warning, which we don't necessarily anticipate, but should that occur, what are you hearing from physicians with regard to the opportunity to kind of work around that. Maybe just as a clarifying question, we've gotten a lot of questions from investors on the possibility that If there were a jack warning, could it actually be post biologic? Doesn't make a lot of sense to us. Just wondering where you guys stand on that proposal. Thanks so

Speaker 2

much. Thank you, Seamus. Let me start on pricing reform and then Chris will comment on ducravastatinib. So first of all, As you know, discussions are ongoing in Congress, and it's difficult to speculate exactly On the bill and some of the details, they will be included in the bill. There will also be obviously a long period during which implementation of some of the measures will be clarified and some of the dynamics would be Really important to understand.

Speaker 2

So with respect to your question on, would there be An impact to innovation. So first of all, we've consistently said that the elements of reform That improve affordability for patients, we are supportive of. And so as an example, the redesign of the Part D benefit and establishing an out of Okay. Cap for patients. That's very beneficial.

Speaker 2

And we are definitely very supportive of that. There are elements in the bill, however, Which are obviously very detrimental to innovation and particularly price setting by the government at 9 13 years, obviously have the potential to have a negative impact On innovation overall, I would say that with respect to the impact for our company, there's 2 things I can say At this point, first of all, it's really not helpful to look at our exposure The channel today, I think it's important to really understand the dynamics that will develop over the next few years before These policies are implemented and a couple of things I'd like to say. First of all, obviously, as you know, REVLIMID Revenues in the U. S. Are declining rapidly.

Speaker 2

Eliquis, we share that 50% with Pfizer. And then importantly, as you think about Opdivo, that loses exclusivity at the end of the decade. So what I can say is that Our rapidly diversifying portfolio and a significant number of new medicines that we're launching today and would be launching before some key elements Of this policy are implemented, position us well to navigate The challenges associated with the reform for the entire industry. But obviously, there is much more than we need to learn, 1st of all, through a potential finalization of the bill And second, really understanding better some of the elements of its implementation.

Speaker 6

So maybe I'll pick up Seamus on the question regarding Dupravacitinib and the launch. So we're as you know very excited about the opportunity to launch this product. As was referenced previously, the commercial and medical Teams are in place. They're ready to go. They're very experienced.

Speaker 6

What I've said previously, I think, is where we'll Start this conversation, which is that we explore every meaningful scenario as we think about the launch of any new product, But we continue to index heavily on the scenario where we think that, the preclinical and clinical data support And that is that this is a unique mechanism of action that is clearly differentiated from other products in the class. And actually, when we talk to customers, we get an almost uniform alignment That's the right way to think about ducrafasitinib. The mechanism based on all of the data that we've seen is unique And it is differentiated. It's differentiated not only from JAKKS, but it's differentiated most importantly from the current standard of care for oral agents treating moderate to severe patients. And so as we step back and think about this product, we anticipate very strong demand for ducravasitinib Based on the clinical profile from 2 Phase 3 studies that show clear superiority relative to the existing standard of care, We have a unique mechanism of action that's clearly differentiated and we think positions us well to become the oral branded of choice for these moderate to severe psoriasis patients.

Speaker 6

And as was implied in the premise of your question, we're very excited to launch this product and we look forward to the PDUFA date in September.

Speaker 1

Thank you, Chris. Sarah, can we go to the next question, please?

Operator

Absolutely. Next, we'll take Luisa Hector with Berenberg.

Speaker 14

Hello. Thank you for taking my question. You showed your slide on business development, Highlighting the importance there, I just wanted to check, has there been any shift in The activity, the trends in companies coming to you versus you approaching other companies, just any more recent trends given the Longer duration now of suppressed valuations, just whether you're seeing any shift in those dialogues that you're having with targets? Thank

Speaker 2

you. Thanks, Luisa. I would say nothing has changed there. It continues to be an area Of great focus for us. We're looking at bringing new science into the company.

Speaker 2

You are right, the valuations are resetting now For a longer period of time, and we plan on continuing to be very active in this field. It's always been a priority for us.

Speaker 1

Thanks Giovanni. Can we go to the next question please?

Operator

Thank you. We'll move on to Tim Anderson with Wolfe Research.

Speaker 15

Hi. I have a question on Milvexion, which is historically when companies have added together I play the therapies or anticoagulant therapies to try to achieve better results. It pretty much always results in higher And that calculation is whether that higher bleeding is more than offset by higher efficacy. So in an SSP setting, Just theoretically ignoring any data you already have at hand, shouldn't we expect that same sort of thing where we would likely see at least some additional bleeding And then we'd have to wait against efficacy or is it in the realm of possibilities that you really don't see any additional bleeding in that triple therapy arm? And then on TIK-two, you guys expressed high confidence in the molecule, wondering why you haven't advanced yet to mild to moderate patients.

Speaker 15

If you're fairly confident in the label, why not push ahead in Phase 3 and Start to expand the market like Otezla has already done.

Speaker 2

Thank you, Tim. Let me just ask Samit, to answer your question both on Milvexion and also plans for ducarvacitinib.

Speaker 5

Yes. Thank you. And certainly looking forward to again the presentation of the Novixis data. And I obviously cannot get into specifics of the data itself, but let me just reiterate that the two questions That would be important from everybody's perspective is on the efficacy, looking at the clinical strokes. And secondly, from a bleed perspective, it becomes very important what kind of bleed and especially when we think about the faita bleed, intraparianbleeds, Meaningful bleeds have become important.

Speaker 5

If you look at the past, what you will see is those kinds of things that made people a little bit So again, we can discuss more when we have the data presented at EHC around meloxicillin. On TYK2, certainly, we are very pleased with the profile for the oral TYK2 inhibitor that has obviously evolved and As we look to the mild to moderate psoriasis, as we've said before, We are looking to bring in the topical formulation, the Phase 2 trial that is about to begin from the Phase 2 or from the TIC 2 perspective and that's our foray into the mild to moderate psoriasis. As you know, the POETIK trial was conducted in the moderate to severe blood psoriasis patients And then of course multiple Phase 3 trials in various indications, first of all in psoriatic arthritis that are ongoing and then FAD starting later this year And Phase 2 trials are ongoing in UC as well as in Crohn's disease. Thank you.

Speaker 1

Thanks, Emma. Can we go to the next one, please, Sarah?

Operator

Thank you. We'll move on to Evan Sigerman with BMO.

Speaker 16

Hi, guys. Thank you so much for taking my question. I want to talk on the kind of dynamics between Opdivo and Opdivo lag. Can you provide more color as to the split between patients who are switched from Opdivo to Opdivo lag? And then one on Turning Point.

Speaker 16

I know kind of when you announced the deal, it was still kind of TBD on the pre NDA discussions with FDA. Any update on that, that maybe will give us more confidence that you're able to launch in

Speaker 1

the second half of next year?

Speaker 4

Thank you.

Speaker 2

Thanks, Eamon. Let me just answer quickly your question on Turning Point before Chris addresses your Obdual Life question. So As you know, we continue to operate as 2 separate companies. At the same time, as we've mentioned before, First of all, we remain confident in the ability to close in the Q3 of this year. And we're still Looking at the launch of Repo in the second half or next year.

Speaker 2

So all good there. Chris?

Speaker 6

Sure. So we're very pleased with where we are with the Opdulag approval and the early uptake. The execution of the team Has been very strong and physician reaction has been quite positive. In terms of the dynamics within the market, Shares in first line metastatic melanoma are in the low double digits for OptoLag. We have seen some Early use in second line plus patients, that's mainly driven by the fact that remember the flow of newly diagnosed Metastatic melanoma patients can be somewhat staggered just given the volume of patients you have in this market.

Speaker 6

And so what we're seeing is not only our physicians using the product In first line, but they're also looking to use it in second line as patients either progress or they're willing to switch patients. In terms of who those patients are, that dynamic is playing out largely as expected. We're mostly displacing PD-one monotherapy. That's to be expected Given the strength of the clinical data with a more than 2x improvement in PFS and a strong trend towards overall survival relative to PD-one monotherapy, We are seeing some modest conversion of Opdivo, Yervoy to Opdulag, but at this point that's very much within the what we had expected. So overall, I would say OptoLag, first, the performance continues to be very good.

Speaker 6

It's early days, but certainly, we have strong momentum. And the interplay between Dual IO, single agent IO and Opdulag is largely as expected.

Speaker 2

Thanks, Chris. Let's go to our

Speaker 1

next question please, Sarah.

Operator

Thank you. We'll take our next question from Terence Flynn with Morgan Stanley.

Speaker 17

Hi. Thanks for taking the question. Maybe, Sumit, as we think ahead to Mil vaccine and the various Phase III opportunities, would just Welcome. Your perspective on why the Xarelto Compass data didn't really change the treatment paradigm in patients with CAD, PAD. Again, I know you're not going to comment in terms of where you're going right now in terms of Phase 3 opportunities, but just trying to think about risk benefit in some of these other populations where Eliquis Hasn't really found much usage.

Speaker 17

Thank you.

Speaker 1

Thank you, Terence. Samit?

Speaker 5

Yes. Look, again, meloxicam is a Factor XI inhibitor and the first of its kind. Certainly, there are others that are in development as well. So looking forward to the presentation of the data and then discussing the Phase III plans, which will be towards the end of this year, the initiation, as Giovanni mentioned his comments early on. I obviously cannot comment on why is it Alto, but certainly Aliquis with its indication you've heard Chris and David mentioned early on as to what has been accomplished with Eliquis and continues to accomplish very effective treatment.

Speaker 5

We are trying to solve the Factor X inhibitors, some of the shortcomings that have been left behind for the Factor X inhibitors and especially From the Phase 2 trial, we're looking at also the combination of it with dual antiplatelet therapies. So But the overall intent for the future development to look at multiple other opportunities in the arterial as well as on the venous side for malignancy and as a single agent as well as in combination with the background therapy. So more to follow and certainly after the data presentation we can have A wider dialogue on the indications and the plans. Thank you.

Speaker 1

Thanks so much. Sarah, can we go to the next question, please?

Operator

We'll take our next caller from Matthew Phipps with William Blair.

Speaker 9

Hi, thanks for taking my questions. Another melanoma landscape question. The results of DreamSEEK were presented at the recent ASCO showing Opdivo, Yervoy maybe should be used even ahead of BRAF inhibitor combinations. Do you think that's enough to drive More uptake about VIVO and Yervoy in that setting in the frontline? Or is this something you're going to explore with additional trials, maybe newer CTLA-four antibodies?

Speaker 2

Thank you. Chris?

Speaker 6

Sure. Well, thanks for the question, Matthew. We have long believed that IO has promised in improving the outcome of BRAF mutant positive patients. Today, as you may know, the use of IO, particularly as a first line treatment In that population is still somewhat limited. It's around 30% to 35% of that population.

Speaker 6

The DreamSeq data that were presented actually last year at ASCO are potentially practice informing In that they provide, I think, important insights into how to best sequence dual IO therapy relative to targeted therapy. And in particular, they show that The use of DUAL IO before targeted TAF MEK therapy led to a significant improvement in to your overall survival. So in that regard, the data are compelling and it can inform practice. The one big caveat to keep in mind here is that targeted therapy combination used for first line BRAF Mutant patients has been very sticky. And so while we may see some use of dual IO in the frontline setting based on DreamSeq, I would anticipate that would be mainly in an academic setting, primarily because that's where the data are going to be most known.

Speaker 6

Remember, we can't promote to this data. So I think it's unlikely you're going to see broader adoption. That said, it's encouraging data and it could have an impact on selected customers.

Speaker 1

Thanks, Chris. Sarah, can we go to the next question, please?

Operator

Thank you. We'll move on next to Carter Gould with Barclays.

Speaker 18

Great. Good morning. Thanks for taking the questions. I wanted to go to Eliquis and exactly kind of what's which countries are baked into sort of The second half headwind, you mentioned the 250 headwind on the quarter. You've made some intra quarter comments.

Speaker 18

And we've seen some additional Countries have generics like Canada. And I guess just bigger picture, is it more appropriate to still think about Eliquis as a tailwind to overall Company growth in 2023, given some of these headwinds, it seems like every month there's a new country sort of launching generics. And I guess then secondly, Just on travacitinib, how are you guys thinking about those IBD indications right now and specifically sort of the viability of those higher doses and if anything has shifted based on your conversations with FDA around psoriasis.

Speaker 2

Thank you. Let me just Start on Eliquis and then David will provide some more insight and Chris answer your second question. So What's referred to by David in terms of the impact of EU Generics For the rest of the year at this point is the UK and the Netherlands. And let me just step back and remind you Where we are in the UK, as you know, the High Court had found our composition of matter balance to be invalid. And obviously, we strongly disagree with that ruling because that's the same patent that was actually upheld and reaffirmed in both the U.

Speaker 2

S. And Canada last year and we're seeking permission to appeal. The Netherlands is very different because In the Netherlands, a generic company decided to launch before the trial, actually took place on the merits. And obviously, that trial is still ongoing. There are generics of Eliquis that we expect to enter the market in Canada that was planned later this year.

Speaker 2

And as we've communicated before, There are similar lawsuits ongoing in other EU countries and every country actually is completely independent And each jurisdiction will make a decision independent. From our perspective, we continue to be Very much convinced about the strength of our IP and we'll defend every case in every country. David?

Speaker 3

Yes. And Carter, also just recall the vast majority of our growth comes from the U. S. And we have patent protection until April 1, 2028. So feel really strong about the growth potential continued growth potential of Eliquis by that.

Speaker 3

But just to contextualize, our business in the UK is about $500,000,000 And what we said is, it will be about between the UK and the Netherlands, it will be about $250,000,000 this year. And as Giovanni talked about in the other European Markets will continue to vigorously defend our intellectual property in there. But hopefully that provides some context

Speaker 9

on how we're thinking about

Speaker 3

the growth potential of Eliquis despite this.

Speaker 6

And then maybe I'll just say something very briefly on IBD and turn it over to Samit to talk about the development. IBD is obviously a large and underserved market. Some elements are more competitive than others, but in general, there's still a need for multiple oral options here. And given the profile that we've seen with, DUCRava, certainly through the psoriasis program, I think from a commercial standpoint, there would certainly be an intriguing But Samik can speak more directly to the clinical plans.

Speaker 5

Yes. So just to keep it very brief, Both trials are ongoing in Phase 2 right now, one in Crohn's disease, one is ulcerative colitis. And based on data, we will be Decisions on development as well as the doses. What I would say, it has no bearing, no bearing at all on in terms of the probability of duparasitinib in September For the psoriasis program, so rest assured in that. Thank you.

Speaker 1

Thanks so much, Eric. Could we go to the next question, please?

Operator

Thank you. We'll move on next to Dane Leone with Raymond James.

Speaker 12

Hi, thank you for taking the questions. Two strategy ones for me, and this is something that comes up in almost every investor conversation. For you guys to win with Milvaxian, the view is that you really have to have that head to head comparative trial versus riva in Afib and Afib is going to represent the majority of the addressable market for a Mill vaccine. And so the question is, from a lot of people's perspectives, from a timeline, it seems like you guys might be behind Bayer on that front. Could you just maybe address what your strategy is to get into AFib, what you view as the timelines for success?

Speaker 12

And then generally, How you view head to head trials is potentially mitigating the LOE associated with Eliquis as we go through this decade? And then kind of to the same point, there's a lot of questions of how you preserve the Opdiva revenues going forward and how much you can actually swap out With further studies of Opdula lag and you have a number ongoing, but what do you really see as the potential of Opdula lag peak sales From what you know now between what's going to cannibalize Opdivo and potentially Yervoy versus where it's going to be de novo Markets for Pure Growth. Thank you.

Speaker 2

Thank you. Let me just ask answer your Obdolide question First and then Samit is best positioned to comment on Milvexion. So on Opdulag, As we've stated before, we see great potential for Obgolag. And as you look at and in fact, we've Articulated our perspective that peak sales for the asset can be from a non risk adjusted basis above EUR 4,000,000,000 in revenue. And that, of course, comes from a number of indications.

Speaker 2

And when you look at the indications that we are currently studying, of course, melanoma It's the entry for Oglolag, but there are trials ongoing in colorectal cancer, liver cancer and lung cancer. And in some cases, those are indications where we currently have a presence with Opdivo. In some cases, they're new indications. You are right that we look at OPDALAG as an opportunity to provide durability to our Hi, O'Franchise and assuming continued successful development, there is clearly a potential for Obdolag to be playing in a meaningful part of the current revenue space for Opdivo. With respect to Milvaxian, Again, Samit will comment.

Speaker 2

Let me just remind you that as he's said before, we'll be able to provide much more insights The development program once you've seen that we presented the data and obviously we're looking at a broad set of indications well beyond Aphiobud Summit.

Speaker 5

Just very briefly, thank you, Giovanni. What I would say is that, there will be data presentation both from the competitor molecule and ourselves at the same time At EFC, neither of the two companies have started the Phase 3 program and partners Janssen and Maya and BMS. We are of course looking forward to initiation of that program later this year. As I said earlier, both on the venous and arterial side of things, Single agent combinations and then we'll be able to talk about the competitors as well. So thank you.

Speaker 1

Thanks, Philip. Sir, can we go to the next one, please?

Operator

Thank you. We'll move on to Colin Bristol with UBS.

Speaker 7

Hey, good morning and congrats on the quarter. On maziktamide, when should we expect to see The 4th line update on this asset. And could you just walk us through the broader development plan and timing around this, please? And then maybe just a follow-up on business development. Just how should we think about this going forward in terms of your therapeutic areas or mechanisms of interest?

Speaker 7

And what are you now thinking is your sort of sweet spot for deal size? Thanks.

Speaker 2

Thank you. Samit?

Speaker 5

Sure. I will start with mesigdemide and certainly the data that we presented already in single agent combination has been Quite interesting and certainly very helpful in terms of thinking of longer term development plan for naziptumide. The data update will be I think at ASH or at the next test conference that we will be able to find for the ongoing single arm open label study. More importantly, as you have In this scorecard that was presented by Giovanni earlier, vosigdemide has 2 Phase 3 trials planned to start in I think 2023, to look at the combination of Kyprolis as well as to look at the combination Maybe in the headcount comparison versus pomalidomide, so those 2 are the 2nd line plus indications where naziktomide is going to be tested and we're looking forward to those initiations in I'll give it back to Giovanni for the BD question.

Speaker 2

Thank you. And from a BD perspective, what I can say is We remain size agnostic. We have tremendous financial flexibility. What we look at is compelling science in areas that we know well and the opportunity to continue to further strengthen the outlook of the company in the second half of the decade and beyond. And obviously do that through deals that generate value for patients and for shareholders.

Speaker 1

I know we're running short on time. I think we got maybe have time to squeeze 2 last ones and maybe go to the next one please, Sarah.

Operator

Absolutely. We'll take our next Question from Mohit Bansal with Wells Fargo.

Speaker 19

Great. Thanks for taking my question. Maybe a question on another question on Kymzio. So when we spoke to cardiologists, there were some concerns raised by general cardiologists talking About ramps and how maybe only partially commit cardiomyopathy clinics, which are with more patients are better equipped to handle this. So one, is it true?

Speaker 19

And number 2, like to what end Bristol can help Make it easy for doctors. And the last one is like, do you know how what percentage of patient population is treated at specialty cardiomyopathy clinics? Thank you.

Speaker 2

Thank you, Chris.

Speaker 6

Sure. So with respect to the REMS and, sort of how that's been received, as I mentioned earlier, The feedback on the REMS process has been very favorable from physicians. It's straightforward to get certified. We've spent a lot of time working with Summit's team Before approval to make sure that the RIMS program generally was intuitive and fit into how Cardiologists generally treat patients and so far that work upfront as well as the education we've done is paying off. Cardiologists are generally seeing it as not a barrier.

Speaker 6

In fact, the fact that we have seen a large number of medium and small clinics Get not only REMS certified, but get patients on the therapy and in many cases get multiple patients on therapy is an indicator of The fact that the REMS program is by and large being seen as something that's very manageable for physicians and hasn't proven to be a barrier at all. Moreover, I think that the RIMS program when we designed it was important to make playing out at this point. So very happy with respect to, what we're hearing playback from physicians on REMS.

Speaker 1

Thanks, Chris. Sarah, can we go to our last question, please?

Operator

Yes. We will take our last question today from Robin Karnauskas with Truist Securities.

Speaker 20

Thank you for taking my question. All right. So quickly on Brianca, I mean, our due diligence suggests still there is like a small fraction, maybe 20% of people eligible that can get the drug. So given that you have a really broad label, you're going into second line, How do you think you can improve this? What steps are you taking to improve the vein to vein or brain to vein time?

Speaker 20

And on DUKRA, just a quick question there. For the moderate patients, how are you viewing? How it will be positioned versus dermaVant or Arcutis' drug? Came in at a lower price, pretty clean safety profile. How are you viewing?

Speaker 20

Any step edits that might be required there? Thanks.

Speaker 2

Thank you, Robin. Chris? Sure.

Speaker 6

What I would say is that on, Briansy, I think in general, the focus that we have had continues to be on if your question is around continuing to improve on the manufacturing side, The focus there has been on making sure that we're focused really on three things. First, on Breanda, you have to on cell therapy generally, you have to stay focused On operational issues, obviously, we spoke about the issue that hit the success rates with this program In the quarter, but clearly that's going to be one area of focus for us. And as part of that, you obviously are continuing to stay focused on improving Turnaround time, and that's a clear focus for the manufacturing team. Above and beyond that though, what I would say is most critical For us at this stage in the launch for both of Beqna and Brianca is to continue to be focused on vector supply and drug product supply, continue to increase that. We're working hard with health authorities to increase capacity on drug supply for Briyonzi at our existing facilities.

Speaker 6

We're also bringing on 2 state of the art facilities In Devon, Massachusetts and at Leitens in the Netherlands, that I think are going to be an important component of how we Continue to expand the capacity for that product coming into the 1st part of next year. And then with respect to ducravasitinib, I think the focus as we look at ducravasitinib is 1st and foremost, recognizing that the most important thing with this asset as you think about access Generally,

Speaker 19

it's going to

Speaker 6

be the value story that you have to tell. And we have a very strong story to tell with ducravasitinib. As I mentioned earlier, we anticipate demand is going to be strong for this. Also recognize that you have 2 Phase 3 studies that show head to head data against the current standard of care for the patients who are being treated with moderate to severe psoriasis. So we have a very strong story to tell with payers.

Speaker 6

And then in terms of those dynamics, I'm actually less concerned about competition with topicals And in particular, because remember, a lot of topicals are going to stay on board as you move into oral therapies and psoriasis. Patients who have plans with open access and as we talked about last quarter, in this market as opposed to other markets that we've talked about, Many patients are covered by plans that will have open access at launch. And then, obviously, we're going to have to continue to build volume In order to expand coverage for those plans that don't have open access at launch, And there, it's going to be all about driving volume and then leveraging that volume to get into a better access position over time.

Speaker 1

Thank you,

Speaker 2

Chris. And from my perspective, let me just say again that what we are hearing from physicians all the time is that they consider Briansy as the best in And I look forward to the opportunity to have a significant increase in capacity at the beginning of next year, Which will be important for us. Now more broadly, I want to thank all of you for participating in the call. This was a strong quarter for the company. We have good momentum with our in line business.

Speaker 2

There are very positive dynamics with our new product portfolio And that positions us well for the second half of the year, which again will be very important for the company. I look forward to continuing to answer your questions and our Our team will be available for any follow-up you have. So thanks again and have a good day.

Operator

Thank you. And that does conclude today's teleconference. We do appreciate

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Earnings Conference Call
Bristol-Myers Squibb Q2 2022
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