Bristol Myers Squibb Q3 2022 Earnings Call Transcript

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Provided by Quartr
October 26, 2022

Key Takeaways

  • Q3 revenues of $11.2 billion were flat year-over-year, with the in-line and new product portfolio up 13% (FX-adjusted) and non-GAAP EPS rising 3%, and full-year 2022 guidance was reaffirmed.
  • This year BMS secured three first-in-class approvals—Sotyktu for moderate-to-severe plaque psoriasis, Opdualag (LAG-3/PD-1 combo) in melanoma, and Kamsayos for hypertrophic cardiomyopathy—marking nine new launches since 2020.
  • The completed Turning Point acquisition adds repotrectinib to the oncology portfolio, expected to launch in H2 2023, and BMS used strong cash flow to pay $3.3 billion for the deal and reduce $2.8 billion of debt.
  • Key pipeline milestones include Abecma becoming the first BCMA CAR-T therapy to show superiority in relapsed/refractory myeloma (Carmatrix data) and Milvexion demonstrating ~30% risk reduction in recurrent ischemic strokes, with late-stage readouts (e.g., COMMANDS, BCMA T-cell engager) ahead.
  • BMS continues to leverage its R&D engine and financial flexibility to renew and diversify its business through mid-stage pipeline advancement and targeted business-development opportunities.
AI Generated. May Contain Errors.
Earnings Conference Call
Bristol Myers Squibb Q3 2022
00:00 / 00:00

There are 21 speakers on the call.

Operator

Good day, and welcome to the Bristol Myers Squibb Third 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, Dennis, and good morning, everyone. Thanks for joining us this morning for our Q3 2022 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Board Chair and Chief Executive Officer and David Elkins, our Chief Financial Officer. Also participating in today's call are Chris Berner, our Chief Commercialization Officer I'm Sumit Harawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can follow along with for Giovanni and David's remarks.

Speaker 1

Before we get going, I'll read our forward looking statements. During this call, we'll 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 not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward looking statements even if our estimates change.

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 the most comparable GAAP measures are available on bms.com. With that, I'll hand it over to Giovanni.

Speaker 2

Thank you, Tim, and good morning, everyone. Starting on Slide 4, I'm pleased to share that we delivered another good quarter We continue to advance our strategy to position Bristol Myers Squibb for sustainable growth. In the 3rd quarter, Our in line and new product portfolio grew by 13%, adjusting for foreign exchange, and we delivered non GAAP EPS growth of 3%, while also making substantial progress advancing our promising pipeline. Highlights for the quarter included the approval of Sotyqtu, our first in class TYK2 inhibitor for psoriasis And closing of our Turning Point acquisition, which brings another product to our portfolio with repotrectinib expected to launch in the second half of next year. Overall, I am very pleased that we have significantly advanced the renewal of our portfolio.

Speaker 2

We have now launched 9 new medicines with 3 first in class products approved this year alone. Let me take a minute to discuss our new products on Slide 5. Our strategy is to accelerate a diversified portfolio of innovative medicines to market to renew our business and grow the company during the period of Revlimitic exclusivity loss and beyond. Supporting this strategy, we delivered 3 key new products this year, Obdolag, Kamzayos and Sotik2. Each is a 1st in class asset and these products have the potential to contribute meaningfully to our growth.

Speaker 2

OPDUELAK marks the 2nd approved IO combination that we delivered. Its strong launch continued during the quarter, furthering our leadership in delivering innovative cancer treatments to patients well into the next decade. We are also encouraged with the progress we have made towards building our foundation for Kamsayos as a specialty cardiovascular medicine. We are seeing increasing numbers of patients initiating therapy, and their feedback has been very positive. David will provide more details on the launch in a moment.

Speaker 2

SOTIQUE2 has been approved with a label that reflects its profile and is an oral of choice medicine for moderate to severe plaque psoriasis. We are very encouraged by the early days of this launch And see significant benefit to these patients with this important new option. Combined with our other launch products, These approvals represent a significant milestone in the renewal of our portfolio, allowing multiple avenues for growth in the second half of the decade And beyond. Turning to our scorecard on Slide 6. During the quarter, we made great progress on our pipeline milestones.

Speaker 2

Abecma is now the 1st BCMA CAR T to have demonstrated superiority to standard regimens in relapsed and refractory Multiple myeloma based on the positive top line results of Carmatrix. We also presented exciting data for Milvexion, which has exhibited an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes on top of dual antiplatelet therapy. It has also shown a safety profile that is differentiated to existing anticoagulants. We believe this asset has great potential as a next generation antithrombotic treatment, and we look forward to initiating Phase III trials soon. Sumit can provide you with the scientific details during our Q and A.

Speaker 2

Turning to Slide 7, You can see several important pipeline catalysts ahead. These include key approvals as well as important registrational data readouts, including the COMMANDS study for Remozil. As you will recall, we've said that our early pipeline would generate Multiple proof of concept data sets over time. Importantly, we are expecting proof of concept data for some exciting assets from our early pipeline in the near term. This data could support transitions of early stage assets over to full development, thereby strengthening our mid to late stage pipeline.

Speaker 2

Some examples include Our BCMA T cell engager for multiple myeloma. We believe this could be a differentiated asset and we expect to present data at ASH in December, our 2nd generation LPA1 agent for pulmonary fibrosis. The unmet need in this disease is very high And should Phase 2 data be supportive, this asset could move into Phase 3 trials next year. Our androgen receptor degrader is generating some early promising data and we hope to transition the asset to full development next year. This highlights the breadth of our protein homeostasis platform beyond cell modes, including in solid tumors.

Speaker 2

These examples demonstrate the power of our R and D engine. With a new wave of innovative and differentiated medicines emerging, which have the potential to treat patients with high unmet medical needs. We look forward to updating you on our portfolio of mid stage assets going forward. With this in mind, let me move to Slide 8 to give you a perspective on how we are thinking about our business Moving forward, with continued strong performance of our in line business and our 9 launches now in full commercial execution, Our priorities have not changed. Delivering the full commercial volume of the 9 launch products, expanding the opportunity for these assets through new indications and advancing our mid stage pipeline.

Speaker 2

Additionally, we will continue to leverage Our financial strength and flexibility to prioritize business development opportunities. As we deliver on renewing our portfolio And transforming our company with a younger and more diversified business, I am confident in the future of Bristol Myers Squibb. We now have critical mass across all four of our therapeutic areas. Each has foundational in line brands, Exciting new products and a broadening mid to late stage pipeline. This is important because we believe That this more diversified business of younger products, supported by constant innovation and focus in therapeutic areas Before I turn it over to David, I want to thank our employees for their relentless focus on delivering for the patients we serve.

Speaker 2

I am confident we will continue to deliver for patients and our shareholders. I will now turn it over to David to walk you through the financials. David?

Speaker 3

Thank you, Giovanni, and thanks again for joining our Q3 earnings call. Let's turn to Slide 10 to discuss our top line performance. Unless otherwise stated, I will discuss sales performance growth rates on an underlying basis, which excludes the impacts of foreign exchange. Revenues in the Q3 were approximately $11,200,000,000 consistent with prior year. Our diversified in line and new product portfolio on Slide 11.

Speaker 3

Global revenues were over $550,000,000 up 66% versus prior year, driven by continued demand. Growth over prior quarter was also strong, up 16%. We continue to be very pleased with the performance of our new product portfolio and its future potential. With 3 new launch brands this year and over $2,000,000,000 of annualized revenue so far, our portfolio has been largely derisked, Increasing our confidence in the potential to generate greater than $25,000,000,000 of non risk adjusted revenues in 2029. Turning to Slide 12 to discuss our performance of our solid tumor portfolio.

Speaker 3

Opdivo sales continue to grow globally, Up 13%, driven by demand for our newly launched and core indications. In the U. S, sales were strong. We continue to grow double digits, up 17% versus prior year, driven by demand of our newer metastatic and adjuvant indications, partially offset by declining second line eligibility as well as some use from Optilog and first line melanoma. Internationally, revenues grew 8%, primarily due to growth from new indications, particularly first line lung and GI cancers.

Speaker 3

Looking forward, we continue to expect growth of Opdivo from our new and expanding indications in both early and late stage cancers. Now let's move to Opdulag. We could not be more pleased with the launch of Opdulag. The launch is off to a great start, being the 1st LAG-three inhibitor to launch in Fixed dose combination with our PD-one inhibitor, Opdivo. Sales in the quarter were $84,000,000 growing 45% sequentially And sales of OptilAg are already annualizing to approximately $350,000,000 At this point in the launch, Our share in first line melanoma is in the mid to high teens.

Speaker 3

And as expected, we are seeing use of OptiLay coming from PD-one monotherapy Moving on to our expanded cardiovascular portfolio on Slide 13, our leading OAC, Eliquis had another strong quarter, up 16% year over year. In the U. S, sales increased 31% versus prior year, driven primarily by demand And favorable gross to net adjustments. As expected, sequential performance was driven by the typical dynamics we experience each year from higher gross to net payments Internationally, Eliquis has become a leading OAC across numerous countries. Given the success of the product, pricing pressures as expected impede growth.

Speaker 3

Pricing measures in addition to at risk generic entry in the UK and Netherlands Effective growth in the quarter. Now turning to KAMZYOS, a first in class medicine to treat underlying disease of obstructive hypertrophic cardiomyopathy. We are continuing to be pleased with the progress we are making to bring this life changing medicine to patients. To date, we have over 2,000 REMS certified healthcare professionals, which is a good indicator for intent to treat. And we've received extremely positive feedback from physicians and patients.

Speaker 3

We are also making progress at large HCM centers to ensure they are operationalized to make KINZYOS available to patients. As of the end of Q3, there were over 1100 patients enrolled in our HUB and growing each week. As expected, new patients are generally initiating treatment as part of their regularly scheduled echocardiograms. Based on the time to transition Patients to commercially dispense medicine, we expect acceleration of revenue beginning in Q4 and as we move into 2023. Chris can provide more details on the launch during Q and A, but we are pleased with the progress we have made.

Speaker 3

Turning to Slide 14 to discuss hematology's performance. Starting with Revlimid, sales in the quarter were approximately $2,400,000,000 Sales were primarily impacted by generic entry, particularly in international markets. In the U. S, we saw slower than anticipated entry by 2nd wave generics in September. We expect to see generic erosion progressively increasing And at this point, we expect RevoMed sales to be at the upper end of our $9,000,000,000 to $9,500,000,000 range for the year.

Speaker 3

POMALYST global revenues grew 8% versus prior year, primarily driven by demand for triplet based regimens in earlier lines, extending the duration of treatment for patients. Moving to Revlissel, which had another strong quarter. Sales were $190,000,000 in the quarter, up 22% versus prior year. In the U. S, revenue growth was impacted by a one time change in distribution model in the prior year.

Speaker 3

Excluding the impact from last year, Sales would have been approximately 25% versus prior year. This is being driven by continued progress in increasing patient adherence and extending treatment duration. Outside of the U. S, REVOZEL continues to grow driven by demand in both MDS and beta thalassemia associated anemia. To date, we are now reimbursed in 9 countries and we'll continue to secure reimbursement in additional countries in the future.

Speaker 3

Now turning to our cell therapy assets, Abekma and Briyonzi. Abekma generated strong revenues in the quarter of $107,000,000 This represents growth of 59% versus prior year or 22% sequentially. In the U. S, sales growth was driven by strong demand, offset primarily by timing of patient infusions, which we expect to materialize in Q4. Outside of the U.

Speaker 3

S, sales increased due to a one time step up of slots in select markets, which is expected to be sustained at this level for the foreseeable future. We are very pleased with the manufacturing progress we've made to ensure Beqma gets to more patients, while we continue to work on further expanding our capacity

Operator

as

Speaker 3

we prepare to move Abekma into earlier lines based upon the positive readout of Karma 3. Finally, On Briansy, sales in the quarter were $44,000,000 up 50% versus prior year. Demand remains strong and we continue to work hard And we'll now turn the call over to Eric to discuss our Q4 results Now turning to our expanded immunology portfolio on Slide 15, Starting with Ciposia. Global sales in the quarter were $69,000,000 up 83% versus prior year largely due to the expansion of Ciposia In ulcerative colitis, sequentially in the U. S, the sales were impacted by last quarter's favorable post to net and wholesale buying patterns of approximately $20,000,000 We continue to see demand growth of 12% over last quarter.

Speaker 3

Our strategy remains focused on further expanding volume, so we can continue to improve Access in 2023, and we made progress on improving the quality of Access as well. Internationally, We are continuing to make strides at securing reimbursement in additional markets to get Saposi to more patients living with MS and ulcerative colitis. Now turning to our most recent launch, the TYK2, our 1st in class selective TYK2 inhibitor for patients with moderate to severe plaque psoriasis. We're extremely pleased with the U. S.

Speaker 3

Label based on PROMIS strong data. While early in the launch, we are very encouraged by the feedback we're getting from physicians. Our focus is to ensure many patients as possible get Certik-two, establishing this medicine as the oral choice, allowing us to secure a broader formulary position in 2024. Internationally, we are also pleased to have received Japanese approval in September, and we look forward to European approval next year. Let's now discuss our 3rd P and L on Slide 16.

Speaker 3

I've already discussed revenues, So I'll now focus on other key non GAAP items in the quarter. Gross margins decreased primarily due to product mix, partially offset by foreign exchange And related hedging settlements. Excluding acquired in process R and D, operating expenses were broadly in line with prior year And affected by the timing of spend, acquired in process R and D charges in the quarter were $30,000,000 related to an upfront payment to Genti Bio. This was offset by $73,000,000 of licensing income benefiting OI and E in the quarter. The 3rd quarter effective tax rate was 16.9%, driven by earnings mix.

Speaker 3

And overall, we delivered another quarter of earnings growth with non GAAP earnings per share growing 3% versus prior year. Moving to the balance sheet and capital allocation on Slide 17. Cash flow from operations in the quarter were $3,700,000,000 The company's balance sheet remains strong with approximately $9,000,000,000 in cash and marketable securities on hand as of September 30, which also accounts for the $3,300,000,000 we paid for Turning Point Therapeutics. Our capital allocation priorities remain unchanged. Business development continues to be a top priority and we continue to execute on this strategy with the closing of Turning Point Therapeutics acquisition as a recent example.

Speaker 3

We remain committed to continued debt reduction. In the quarter, we repaid $2,800,000,000 of debt, and we remain committed to returning capital to shareholders. We executed a $5,000,000,000 ASR earlier this year and have $9,500,000,000 remaining in our share reauthorization, and we will continue to be opportunistic on share repurchases. Now turning to our 2022 non GAAP guidance on Slide 18, We are maintaining our full year outlook. We continue to expect revenues to be approximately $46,000,000,000 with our in line and new product portfolio growing in the low double Our recent LOE guidance and Revlimid guidance remain unchanged.

Speaker 3

However, as mentioned earlier, we We continue to expect gross margin to be approximately 79% And our operating expenses excluding acquired in process R and D remain unchanged primarily driven by favorability in FX as well as cost discipline, partially offset by the inclusion of expenses from the Turning Point acquisition. Putting everything I just mentioned together, we are reaffirming our Full year non GAAP EPS guidance reflecting the strength of our underlying business and absorbing the approximate $0.06 impact from Turning Point acquisition. Before we move over to Q and A session, I want to express my gratitude to our employees for the performance in the quarter and their continued commitment to our patients. I'll now turn the call back over to Giovanni and Tim for a Q and A session.

Speaker 1

Great. Thanks very much, David. Dennis, can we go to the first question, please?

Operator

Thank you. The first question comes from the line of Chris Schott with JPMorgan. Please go ahead.

Speaker 4

Great. Thanks so much. Just 2 for me. I guess first on SOTYC-two, given the favorable label, can you just talk about the Target patient population you're going to be going after here. So specifically, are you going to be looking mostly at OTEZLA failures initially?

Speaker 4

We're going to focus more, I guess, on first line patients starting on systemic therapy. I know you've talked a little bit also here about reimbursement dynamics, but is there anything you can do to accelerate this process prior to this kind of 2024 timeline that you've been kind of alluding to? And then the second quick one was just on Eliquis. I think we've had a few quarters now where we're seeing kind of a positive price adjustment. I just was wondering if you could elaborate a little bit on the dynamics there.

Speaker 4

And is this something that's more one time in nature And will reverse or is this kind of just a new base we should think about for the business, we think about kind of volume growth going forward? Thank you.

Speaker 2

Thank you, Chris. I'll Chris Bernal will start and then David will give you some comments on that.

Speaker 5

So let's start with SOTEC-two. Thanks for the question, Chris. First, I think the launch of Sotek 2 is off to a very good start. We're extremely happy with what we're hearing back from physicians. We've seen a very nice Week over week acceleration of this product, the majority of the use right now that we're getting is coming from the community setting.

Speaker 5

That's really important because, Chris, as you may know, about 80% of the volume in this setting is going to be in the community. And so to see that level of Take there early on is nice to see. Also remember that the awareness of this product in the academic community going into the launch was very high. So the fact that we've got good uptake early in the days of this launch coming from the community is a good early start. In terms of the patient population that we're looking at, We're actually going to be focused on the dynamic portion of this population, which includes both initial starts in the first line setting As well as any of those failures who are coming off of Otezla, we're also seeing some early switching, though that's Again, very early days, but I would say that the primary focus of this launch continues to be squarely on Otezla, And that would be patients who would have gone on to Otezla in the absence of TYK2 as well as for those patients who Have either failed that product or physicians decide to switch given the efficacy profile that we're seeing with SOTIC-two.

Speaker 5

In terms of what we're seeing on the Access side, our focus continues to be threefold on Access. 1st, removing the market new to market Blocks that face all new products in this space. Second, taking advantage of where we have open access today. And remember, we estimate that about 10% of Patients have open access, at the initial stages of this launch. And then obviously, it's all about building volume During the early phases of the launch and then leveraging that volume, we're going to do everything we can to accelerate getting into a better access position in 2023.

Speaker 5

But we certainly feel like we're in a very good position and on track to be in a good position in 2024.

Speaker 3

David, yes. And on the Eliquis rebates, remember this is a very large product, over $10,000,000,000 in revenue. And based upon the product mix, we forecast What the anticipated discounts will be based upon the product mix across all the payers and each quarter we adjust that some quarters are up and some quarters are down, but the last two quarters We had some releases and that's what really explains it, but nothing changes for the full year really.

Speaker 1

Thanks, David. Dennis, can we go to the next question, please?

Operator

Yes. Your next question is from the line of Seamus Fernandez with Guggenheim Securities. Please go ahead.

Speaker 6

Great. Thanks guys. So So the first one is just on the competitive landscape that's evolving in ulcerative colitis. Can you guys just give us a sense of how the launch of ZYPOZIA is tracking in MS versus UC? And what percentage of patients are you seeing specifically at this point, as we look at the sort of separation of scripts?

Speaker 6

And how you're thinking about the competitive landscape evolving with the increasing interest from physicians in IL-23s, Perhaps even the combination of IL-23s with biosimilar Humira as a Potential new breakthrough in the category. Just wondering what you guys were thinking coming out of the most recent meeting as well. And then just the last second question It's on the Kymzyos launch. Just trying to get a sense of when you guys Anticipate seeing a meaningful inflection in prescription or revenue. Is this something where we should anticipate seeing a meaningful uptick in 4th quarter, or is it potentially with the new indication in

Speaker 5

the middle of next year?

Speaker 7

Thanks so much.

Speaker 2

Thanks, Seamus. So Chris and Samit will address your question on UC and then Chris will comment on Kansaios.

Speaker 5

Sure. Thanks for the question, Seamus. With respect to, Zposia, I would say Zposia continues to perform well. We saw nice Double digit demand growth in the quarter. The majority of that growth is continuing to come from ulcerative colitis.

Speaker 5

So I would say that the majority of patients, if you look at Where the growth of this asset is going to occur through the end of this year and certainly as we get into next year, the majority of that's going to be coming From UC, the market share that we have for Zipposia in MS continues to remain stable, About 50% of the share in S1Ps is coming to Zipposia. We feel Very good about the position that we're in there. Obviously, as we've talked about previously, the oral market in MS is under Some pressure from IV, but in spite of that, we're maintaining a consistent share in the MS population. The big focus that we have And I would say that there, I think that from a competitive standpoint, so far the position for Zposia continues to be strong. Obviously, it is a very competitive But for example, with the introduction of RINVAC, that the growth of RINVAC has not largely come at the expense of Zapposz, in fact, we've maintained our position in that market in spite of the introduction of that new asset.

Speaker 5

Clearly, there are a number of dynamics that are going to continue to play out, But we feel pretty good about our competitive position as the 1st S-1P in this market for UC. The only other thing that I would note Is that obviously, as we've said, the big focus we have with Zapposia is to build volume and then convert that volume Into a stronger access position, we did get a very important early win on the access side in October with CVS Zinc now covering Zephozia with 0 step edits. That's important because if you add that with the other plans that smaller plans that have covered Suppose we now have about 30,000,000 covered lives and we're well on track to be in a good position with the other PBMs as we go into 2023, and maybe I'll let Samit address the other part of that question, and then I'll pick up on KAMZYOS.

Speaker 8

Yes. Very briefly, Seamus, the way we think About it is that unmet medical needs still remains very high in patients with ulcerative colitis and certainly new medicines are needed. As you know, we have our own clinical development plan ongoing with SOTYK2 in ulcerative colitis. 2 of the trials will read out From a proof of concept perspective in 2023 for CD and UC, UC would be in the second half of the year and we will continue to explore if those Trials that lead to future development as well as if combinations are going to be the possibilities of the future with short incentive care or novel therapies. So more to come, But we need to first see the data.

Speaker 5

And then picking back up on your question on KAMZYOS.

Speaker 9

I

Speaker 5

would just say at the outset, we are very pleased with the launch We're seeing a really nice acceleration for this product in the second half. A few, elements of color around that. First, we talked about the importance of Certified physicians. We now have over 2,000 REMS certified physicians as of the end of the second quarter. We're seeing a nice healthy increase in that week over week.

Speaker 5

David referenced that as of the end of Q3, we had 1100 patients who had been prescribed KAMZYOS. That's also seeing nice Week over week increases, I think we had referenced on the previous quarterly call that a big focus area has been helping Some of the larger institutions build the infrastructure to support the use of this product. We've seen very significant improvement on that in recent weeks. And the pace of new starts that we're seeing is consistent with those accounts in particular getting organized. Nearly All of the patients that we are seeing are going through our KAMZYOS patient hub and that's really important because that will facilitate getting patients on to therapy and staying on therapy.

Speaker 5

And I think it's notable that of the patients who have had multiple dispenses thus far, none of them have Dropout therapy, which is a nice indicator of how well that hub is working. I think the question with respect to how fast we're going to see an acceleration of revenue Speaks to this question of access. Access, as anticipated, has not been a barrier with this launch. We now have about 50% of plans Coverings of KAMZYOS. All of the patients who are covering KAMZYOS are being PA'd to the label, which is a good indicator of a strong position.

Speaker 5

And you will have seen on the slides that As of the end of Q3, about a third of those 1100 patients had converted to commercial drug. In October alone, we've seen an almost doubling of the number of commercial dispense that we saw in Q3. So We feel very good about the pace of this launch and what we're seeing in the second half, and happy obviously to provide additional color as this launch continues and we get into the Q4 call.

Speaker 1

Thanks very much, Chris. Dennis, can we go to the next question, please?

Operator

Your next question is from the line of Andrew Baum with Citi. Please go ahead.

Speaker 10

Thank you. You addressed the route of the leventan in your prepared comments. I'm just curious, same topic on Onuric. Given the attractiveness of the drug as a neuro alternative, I'm surprised it's not doing better. Perhaps you could outline what are the barriers here and some of the key catalysts ahead.

Speaker 10

And then second, in relation to Molvexion, the 200 milligram dose, the efficacy was inferior to placebo.

Speaker 2

Thanks, Andrew. Chris, why don't you start on Onurag and then Samit will answer the question on Nalvexin.

Speaker 5

Sure. The question on Onurag around some of the barriers that we're seeing. I Say that the biggest challenge with Onurag continues to be the proportion of patients who are getting intensive chemotherapy. As you know, those dynamics In the first line setting here are continuing to evolve. We've seen a decrease in the U.

Speaker 5

S. Mainly of the Percentage of patients who go on to get intensive chemotherapy and remember the label is for patients who receive intensive chemotherapy and get a complete response. Having said that, our focus with Anurag continues to be on ensuring that we maximize the opportunity for maintenance. The maintenance share right now is about 50% to 60%. We think there's We continue over time to expand that maintenance market.

Speaker 5

And for those patients who get into the chemotherapy, get a complete response, go on to maintenance, The choice needs to be on Eureg, and so that's been the significant focus we have for the U. S. Team. And then we continue to see Very early stages of launch outside of the U. S.

Speaker 5

And markets like Germany and France and the early uptake there has been good. And Andrew,

Speaker 8

thank you The question on Malvixin, yes, certainly we looked at the hypothesis around COVID and the 200 milligram dose. It doesn't seem to be driven through there, but we are continuing to Why the group stood out? But the point to be taken home, I think, remains that we have an eightfold dose range that is available to us We're picking the right dose for the Phase 3 trials and we are in that place where we are now looking forward to initiation of the program In the next few months on the Phase 3 side with the 3 indications that we've spoken about before in AF, ACS and SSP.

Speaker 1

Okay. Can we go to the next question please?

Operator

The next question is from the line of Chris Shibutani with Goldman Sachs. Please go ahead.

Speaker 11

Thank you very much. If I could ask a question about how you see dynamics in the multiple myeloma setting, particularly the interplay between CAR T therapies and with anticipated arrival of bispecifics as an option. Could you perhaps talk about where you see the dynamics playing out in 2023? Secondly, on OPDUALAG, There has been a good revenue performance there. Can you remind us what your strategy is for broadening those label opportunities and when we might be able to see data to

Speaker 2

Thank you, Chris. Samit?

Speaker 8

Sure. Thank you, Chris, for the question. On multiple myeloma low, I think the Starting point is that no matter how many therapies have been developed and become available, the disease remains uncured at this time. So there is an opportunity to continue to bring In terms of getting patients into a complete remission and hopefully those are very long lasting. The bispecific as 1 has been approved today in the U.

Speaker 8

S. Or yesterday in the U. S. And certainly in the U. S.

Speaker 8

As well, is a new armamentarium, certainly brings a good efficacy. However, As you saw from the data that have been presented, there are opportunities to continue to improve on the safety profile. High rates of CRS are going to be problematic as you also saw Some of the statements made by thought leaders and that's where differentiation will need to continue to occur. We will be presenting our own data at ASH this year For a T cell engager and you'll see that. I think the other way to look at it is the holistic development in multiple myeloma where we are also developing now initiated 3 Phase 3 trials with CellMODs and the future probably will look like a combination approaches of T cell engagers or Cell therapies and how cell mods can be added to those.

Speaker 8

So we have a holistic approach of treating multiple myeloma And trying to get more and more patients into very long, durable, complete responses and at some point, someday getting to a cure. Do you want to add something to that?

Speaker 5

Sure. Maybe I'll just add that while bispecifics and CAR T both share, in this case, the target of BCMA, I think it's important to keep in mind they offer very different characteristics for patients, including the availability of the products, The duration of treatment, adverse event profile, and I think ultimately, as we've said repeatedly, the utility of BCMA CAR T And bispecifics is going to be unique to each patient, and the setting that we're in. And we anticipate that These various patient factors are going to become increasingly important in determining, how patients are treated. And then maybe before I turn it over to Samit about the Expansion of Opdulag, let me just say at the outset, we continue to be very impressed with the strong performance of Opdulag out of the gate. Our focus has been and will continue to be to target that PD-one monotherapy population.

Speaker 5

I think as David alluded to, we're seeing Use of conversion of both Opdivo, Yervoy patients as well as PD-one monotherapy to drive that use as of today. But as we think about the growth of this asset going forward, remember, where we sit today PD-one monotherapy is still about 20% of first line Metastatic melanoma, and that's the target for, our commercial launch. And so we see continued opportunity to grow this asset through the end of this year and well into next year.

Speaker 8

And I think in addition to what Chris has just spoken about, there are obviously many other trials that are ongoing. In the Phase III setting, we've got the melanoma study in the adjuvant setting as well as the CRC trial in the 2nd line plus setting in MSS colorectal cancer and then looking into The continued enrollment in the Phase 3 portion Phase 2 portion of non small cell lung cancer randomized portion as well as the 2 studies ongoing in HCC and multiple other signal studies ongoing with our collaboration with investigators. So obviously, as the data emerges, we can take that program forward to multiple other indications.

Speaker 1

Thanks, Philip. Dennis, can we go to the next question, please?

Operator

Yes. The next question is from the line of Tim Anderson with Wolfe Research. Please go ahead.

Speaker 12

Thank you. Going back to Milvexion, I'm just trying to understand why we haven't seen Phase 3 trials Start yet, you've had the data for a number of months and something like atrial fibrillation, you didn't run Phase So there's no data specifically in that setting to analyze. You're in a race with other companies. So why haven't we seen anything posted yet? It's almost makes me wonder is FDA preventing you from advancing yet And are there concerns or something like that?

Speaker 12

And then second question is just a general pipeline one for Samit. It's been a pretty big positive news flow in 2022. I think there's the view that you go into more of Catalyst light period in 2023. So, Sam, what are the next 2 or 3 most important clinical catalysts coming up, Let's say over the next 12 months in your view.

Speaker 2

Thank you, Tim. Let me ask Samit To answer your question both on Molvexyan and the pipeline, I just want to say with respect to the pipeline, Tim, as I mentioned in my remarks, I think what's really exciting is that actually the mid stage pipeline is beginning to accelerate and the number of catalysts there

Speaker 8

And Tim, thank you for the question. I'm glad that you are as excited as us in terms of initiation of the Phase 3 program. Once the trial reads out, we have to get in touch with the health authorities, agree on the dose, agree on the overall trial design, and then we can initiate the plans By submitting the protocols to IRBs, to ethnic committees, to the institutions, they have to go through before we can actually enroll patients. So All of that is being worked through. We have our partner Janssen and us.

Speaker 8

We're working very diligently, very closely to get the program started in the next few months. You'll get to hear the initiation of the Phase 3 program for malvixent. In terms of the pipeline and what's the new catalyst in the next year or 2, I've I've talked about it before and I think our pipeline is fortunately very full. And each of the therapeutic areas has multiple opportunities beyond meloxicienan. For example, in cardiovascular space that we've spoken about, I think we are looking forward to some of the readouts in the immunology space As we think about cindacumab over the next couple of years for the ongoing eosinophilic esophagitis study, as well as I think Giovanni spoke about in his opening remarks, LPA1 proof of concept study, if that reads out and if the data are similar to from an efficacy perspective, what we saw a couple of years ago or in 2018, the Just publication that could open up the doors if the safety profile is well managed.

Speaker 8

In a similar way, We have repotrectinib that will be registered and hopefully available in the second half of next year for patients with non small cell lung cancer with ROS mutations. And as the data emerges, there are a few transitions that could occur in 2023 as well from early to late development such as androgen receptor lag independently greater And then of course, there is the readout for the COMMANDS trial that we are anticipating So there are multiple other catalysts that are coming through in the pipeline in 2023.

Speaker 1

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

Operator

Yes. The next question is from the line of Steven Inskalo with Cowen. Please go ahead.

Speaker 13

Thank you. Revlimid continues to exceed expectations, presumably creating a tough compare for 2023. So I'm just wondering at this point, are you comfortable with consensus looking for growth for Bristol overall next year? I know 2023 guidance will be issued next February, but if you could tell us whether you're comfortable or not willing And then secondly, on branobrutinib, 3 programs were discontinued, only RA remains. Why were the other programs discontinued and RA continues?

Speaker 13

If it was due to tox, can you specifically tell us whether it was liver tox? Thank you.

Speaker 2

Thank you, Steve. I want to ask David to start on Revlimid and outlook and then Sumit will answer your question.

Speaker 3

Thanks, Stephen. On Revlimid, as we said in my remarks, we still anticipate for the full year, Revlimid to be in that $9,000,000,000 to 9,500,000,000 More in the upper half of that range, but as we said all along, we're going to have quarter to quarter variability based upon how generic volumes enter the market and timing from quarter to quarter. So broadly, we're still in line with the forecast that we had provided before. As far as 2023 guidance, underlying business, we continue excluding foreign currency. As we see this year, we continue to be able to grow the business.

Speaker 3

And We'll provide an update on 2023 guidance as we normally do on the Q4 call.

Speaker 8

Thanks, David. And just Steve, on the banebrutinib side, It is certainly not the toxicity. We've set ourselves high bars for taking molecules into late stage development and we did not meet the high bar for those indications. The indication for RA is continuing and we'll see what the data reads out and based on that data that we'll make a decision whether that should continue or not.

Speaker 1

Dennis, can we go to the next question please?

Operator

Yes. Your next question is from the line of Luisa Hector with Berenberg. Please go ahead.

Speaker 14

Hi. Thank you for taking my questions. Maybe just to try again on the outlook For 2023, is there anything more to say on Revlimid? You've had the guidance of €2,000,000,000 to €2,500,000,000 of erosion each year. Is that what you're expecting for next year?

Speaker 14

And then I wanted to try and clarify on some of the license income Partly connected to your statements on IP Guarantees, but also when we look at that line within other operating income, royalties, Licensing comments does seem to be a step up in Q3. So I'm just wondering if that's driven perhaps by the diabetes With Astra that's going particularly well on FOXEDIA, is there a one off item within the line in Q3 or something a bit more sustainable

Speaker 2

Thank you, Luisa. So let me just reiterate, nothing really changes with respect to 20 3 in terms of our outlook, and that includes the fact that we continue to see approximately $2,500,000,000 of decline for Revlimid. But David can give you more insights into the second question you had.

Speaker 3

Yes. On OI and E, it's a good question. A couple of good things that are going on there. One is that Our royalties on PD-one and diabetes continue to as those businesses grow, the royalties that we receive on those businesses continue to grow. A couple of other things, if you just think about interest rates with our cash balance, interest income is increasing.

Speaker 3

But as you know, we've been stepping down and paying down our debt. So our interest expense has been declining, and some of our licensing income that we've seen come through has also improved. So you put all four of those factors together and that's how we see the OI and E progressing better over time. Just to recall, the longer term as it relates to that royalty income, those royalty rates will step down on our BD's franchise in 'twenty three and going and 'twenty four for PD-one. So we'll update you on that guidance when we do guidance on the Q4 call.

Speaker 1

Thanks, David. And if we go to the next question, please.

Operator

The next question is from the line of Terence Flynn with Morgan Stanley. Please go ahead.

Speaker 9

Hi. Thanks for taking the questions. Maybe 2 for me. I was just wondering, first on Kamsiose, just Maybe for Chris, as you mentioned that commercial access is improving this quarter relative to last quarter. I think you said something about doubling.

Speaker 9

So Does that mean we should think about sales for 4Q in the $10,000,000 range? And then your T cell engager, the data we're going to see at ASH, Maybe you could just remind us, I know you changed the formulation to a subcu there. If you're confident, you now have a go forward dose and you're seeing less CRS Then maybe you saw the IV formulation and if you expect to be competitive with teclistamab, which was just approved from J and J. Thank you.

Speaker 2

Thank you. Chris, why don't you start on Kamsaios and then Samir.

Speaker 5

Sounds good. So Terrence, thanks for the question. Let me clarify a few things. First, Well, we're not going to give specific product level guidance for the Q4. What I would say is that we are very happy with the conversion and increasing conversion of Patients on Kamsios, to commercial drug.

Speaker 5

Remember, as you think about this launch, you need to think about it in the context of how many physicians are REM certified, Our ability to then translate those physicians into getting patients into clinics and getting on therapy, we're seeing a nice increase week over week in terms of patients coming in at Top of the funnel, if you will, because they're going into our hub, they're staying on therapy. And the fact that now we're converting those patients To commercial drug at a faster clip, I think is a very good sign that this launch continues to accelerate in the Q4. The only other thing to keep in mind is that because most Patients will take some time to initiate therapy as well as work through the benefits verification and any appeals process. Those patients are going to be on free drug for roughly 7 to 8 weeks. That time will decrease over time as we get PBM Coverage decisions formally through the end of this year and into early next year, but that's how you should think about the flow of patients and the sequence of patients.

Speaker 5

The really good news though is that we continue to see physician interest in this product. The feedback has been good. We're seeing week over week increases in patients at the top and we're seeing a nice Increasing conversion of patients going on to commercial drug and we anticipate that continuing.

Speaker 8

And Terrence, for the T cell engager, certainly we'll not get into the The profile was not acceptable and that's why we switched to subcutaneous and the data will be presented. So certainly after the presentation of the data, we are happy to get into a Dialogue as to what the data are and how we perceive them as we go forward.

Speaker 1

Thanks, Sumit. Dennis, can we go to the next question, please?

Operator

Yes. The next question is from the line of Carter Gould with Barclays. Please go ahead.

Speaker 15

Great. Good morning and thanks for all the color on Cam's Ios. I Two more on that front, though for Samit. I guess first off, we saw that the non obstructive trial design, the Phase 3 got posted. Just wondering, But it's pretty sparse on details on how you're thinking about titration in the setting given the Phase 2 work that was done here was More drug concentration dependent.

Speaker 15

Obviously, the REMS is more echo dependent. So just how you're thinking about titration in the non obstructive setting? And then also on 224, How do you think about this? Should we be thinking about this as a backup to Kamsiose? Or Do you see this coexisting maybe in a different set of indications like HFpEF, etcetera?

Speaker 15

Thank you.

Speaker 8

Sure. Let me start with KEMZYOS first and the non obstructive hypertrophic cardiomyopathy. We are looking forward to initiation in terms of enrollment of patients in that Phase 3 study. The data that we had seen already in the Phase 2 was quite promising, looking at the impact on biomarkers and even in the longer term follow-up of that trial. I can't give you the specifics on the titration at this time and certainly for future discussions.

Speaker 8

Once we have initiated the trial, we'll be able to talk more about it. For MYK-two twenty four, as you know that we always want to have multiple shots and this is a new molecule that we are developing. Certainly the first trial that you Probably, C is going to be looking also at obstructive atrophic cardiomyopathy. And the reason for that is because we've got Chemsyos data. We have in house data the way we would want to compare the trial compare the drug and see what differentiation features the drug carries.

Speaker 8

And then as we look to the future from a development perspective, we'll define which indications we want to pursue with MYK-two twenty four, which indication we want to replicate with Chemsios. We have not defined and decided yet on how we will develop 224 and certainly when we have that, we'll get into that dialogue as well.

Speaker 1

Thanks, Sumit. Dennis, can we go to the next question, please?

Operator

The next question is from the line of Matthew Phipps with William Blair. Please go ahead.

Speaker 16

Good morning. Thanks for taking my questions. Just a quick one for me. Samit, there's been a couple of failures this year in EoE, where maybe the Phase 2 is a 50 histological endpoint, but not the dysphagia endpoint. Just maybe you can give us any comments on why you think IL-thirteen would be better suited To the IL-thirteen, to hit both of those endpoints in your AOE Phase 3?

Speaker 8

Sure. Sure. We can certainly the one that you're probably talking about is the one that we saw yesterday or day before for the EOE. Remember the mechanism of There is the IL-five inhibition as opposed to cindacumab where it is the IL-thirteen inhibition. The differentiating feature also compared to some of the other drugs that are approved Or have shown data, this is a direct inhibitor of IL-thirteen with a downstream effect of inhibition of both R1 and R2 receptors.

Speaker 8

And we believe that the inhibition of both is important not only for decreasing the inflammation, but also for remodeling and reversing the fibrosis. We have seen this in the Phase 2 trial that was presented a while back for syndacumab and that was the basis of taking this into a Phase 3 trial And certainly we'll be looking at dysphagia and this trial as well. So in a couple of years when the trial reads out, we are hoping to be able to replicate and improve on the results of the Phase 2 study.

Speaker 1

Let's go to the next question please.

Operator

Next question is from the line of Collin Bristow with UBS. Please go ahead.

Speaker 7

Hey, good morning and thanks for taking the questions. Maybe just a quick follow-up on the TYK2. You previously talked about the Strategy to build volume against established competitors with sort of free drug or bridging programs. Could you just give us some more specific details on what you are doing there Just to help us think about the progression of the sales trajectory. And then just secondly, on the next generation IMID portfolio, what should we Specifically, expect to see ASH with regards to iberdomide and mesigamide?

Speaker 7

Thank you.

Speaker 5

Thanks, Kevin. Chris, why don't you start on Cetikta and then Sumit will take the IMET. Sure. So as we think about the progression of SOTYK2, I think you start with a couple of things upfront. One is The profile of the drug, we've talked about that at some length that the fact that we have a very clean label here gives us the ability to tell a very strong story about 2 Phase 3 studies That directly show an efficacy improvement against the existing standard of care.

Speaker 5

So we've got a great efficacy message Chatel, good safety profile. The value of this asset is very clear. We saw that coming into this launch and all of the feedback that we've received from physicians Thus far, it's consistent with that. The next important point is that we've got a very experienced team. They know this space well.

Speaker 5

So we've been able to penetrate where the vast majority of these patients sets, which is in the community setting. So we feel very good about that. The trick with this space, because it is a heavily managed space, is going to be that we do a few things really well. Initially, We've got to remove new to market blocks. Those blocks are put in place for every new product in the space, and that's a big focus for us right now.

Speaker 5

We then have to take advantage of where access is open. And as I said earlier in response to the previous question, that's about 10% of patients. And so we're doing everything we can there. But for the majority of patients, the focus is on building volume and then leveraging that volume to negotiate with PBMs to get you into a more favorable formulary position as soon as feasible. Because of the timing of this launch, we certainly missed the window by and large For negotiations this year, the focus will be on negotiating for 20 4 Access, though in response to Chris' earlier question, We're going to do everything we can to accelerate that.

Speaker 5

So that's really the focus that we have. We have a robust And we would anticipate significant use of that bridge program, to guide us into when we have a more favorable formulary position.

Speaker 8

And just talking about ASH, in general, one of the things that you will be seeing over there is the presentation of the data for the expansion arm From multiple myeloma, we will also be presenting the data for our next CAR T, which is GPRC5D targeted, As well as for Karma 2, one of the arms which is looking at proof of concept in the post transplant treatment setting, that data will also be presented at ASH in addition to elenoptimumab, which is the T cell engager.

Speaker 1

Thanks, Sumit. Can we go to the next question, please?

Operator

The next question is from the line of Evan Seagramen with BMO, please go ahead.

Speaker 17

Hey, guys. Thank you for taking the question. One on Efpekma, Can you provide just some color as to when we may see the CARME-two data? I know that the 2 70 press release later a medical meeting, And I see that there's now a green check mark on your near term catalyst. And then

Speaker 5

also more broadly speaking, When you

Speaker 17

think about the evolution in the BCMA CAR T space, what do you how do you position abecma versus, say, the competitors, especially with, I

Speaker 8

will start with that, Evan. And from a Karma, 2 data presentation perspective, certainly, as I said earlier, those data will be there as a proof of concept with a longer follow-up At ASH meeting and certainly we've talked about what the initiation of the next trial based on those data would be and that's what I think 2 70 Bio had talked about, How we intend to initiate a trial in the earlier setting, it is a differentiated way of looking at it And more details will be available when we actually do launch the trial in terms of trial design and how we have thought about it. In terms of the comparison of Beqma versus the data from CARVECTI. Once again, as Chris has spoken about earlier, we do believe that Beqma remains a very differentiated asset From a safety profile perspective as well as the first CAR T that has data as a randomized Phase 3 trial Showing superiority to current standard of care. So that profile will continue to grow and that profile will continue to improve hopefully.

Speaker 8

And that's why we are thinking of initiation of that early line trial In the post transplant setting.

Speaker 1

Thanks so much. Can we go to the next question please, Dennis?

Operator

The next question is from the line of Dave Leon with RGF. Please go ahead.

Speaker 18

Thank you for taking the questions. Congratulations on the results and progress this quarter. 2 easy ones for me. Firstly, The launch of Opdulilag has been going quite well. And looking into 2020 I think there's still some questions about the cannibalization potentially within the melanoma setting relative to Opdivo.

Speaker 18

As the Street is still expecting quite robust growth of Opdivo into next year, could you just comment around what you're seeing as the launch Starts to mature a little bit with Opdivo lag and whether your expectations are that going to have limited impact in the utilization of Opdivo in the melanoma setting. And then secondly, an easy one, are you expecting Embark results for Kamsiost next year? Or is that being pushed to 2024? Thank you.

Speaker 2

Thank you, James. Chris, why don't you start?

Speaker 5

Yes. Maybe I'll start with, OptilAg and I'll turn it over to Sumit. So What we're seeing right now just to set sort of where we are with the OPTULAG launches, we are sourcing roughly 50% to 60% of this business from PD-one monotherapy and about 40% to 50% from Opdivo and Yervoy Combination. That's slightly higher Opdivo, Yervoy cannibalization in the Q3 than we had anticipated pre launch, But we expect that to stabilize and we would continue to expect that going forward, the majority of OptilAg's business is going to come from PD-one monotherapy. Remember, in the market right now, as I said earlier, we've got about 20% market share for PD-one monotherapy.

Speaker 5

That's roughly evenly split between Opdivo And KEYTRUDA. So the way I would think about the progression of Opdulag is, 1st and foremost, you will see some cannibalization Come from PD-one monotherapy. Some of that will be Opdivo, some of that will be from a competitor. And as I think about the growth trajectory, That 20% share is the target for us of PD-one monotherapy. That's where we think we should be getting the business.

Speaker 5

And the fact that we still have 20% of this market to go gives us Confidence we can continue to grow this overall business going into 2023. And just on Embark results, those are Projected to be in 2024.

Speaker 1

Thanks. So McQueen, go to the next question please, Dennis.

Operator

Your next question is from the line of Mohit Bansal with Wells Fargo, please go ahead.

Speaker 19

Great. Thanks for taking my question. So one clarification and one question, if I may. On Kymzyos, Chris, I think you mentioned that 1 third of the patients who are prescribed Kymzyos are on commercial, but then you mentioned that In October, we have seen doubling of that. Can you please clarify what is doubling here, number of commercial patients or the funnel or Prescription for KANZYUS.

Speaker 19

And then the second part of the question is regarding milvaxian. The indications You have mentioned SSP and ACS. These seems to be a little bit of acute type of indications. So yes, the patient number are high, But duration of treatment may be smaller.

Speaker 2

I

Speaker 19

think that is only for a month or so after a stroke. So Just trying to understand how should we think about the opportunity in these

Speaker 2

acute type of settings? Thank you.

Speaker 5

Sure. Maybe I'll start on the Kymzios question. So let me just clarify the 1 third. Of the 1100 patients, roughly 1100 patients that we had as of the end of A third of those patients had dropped down to commercial drug beyond commercial drug. And what I was referencing was in the first 3 weeks of October, we've seen an almost doubling of the number of commercial dispensers that took place through all of the 3rd quarter.

Speaker 5

So that illustrates an important consideration for the trajectory of commercial sales here for this product, which is that We're starting to see an acceleration both in terms of the number of patients coming on to therapy and the pace at which those patients are converting down to commercial drug.

Speaker 8

And on the Malvixion side, although the word says acute coronary syndrome, but it doesn't mean that the treatment is only done in the acute setting Or even for the secondary stroke prevention patients actually stay on antiplatelet regimens, for example, for a very long time on a chronic treatment period. And so in a similar way, Melvixion is anticipated to be used in a chronic setting rather meaning the long duration of treatment rather than only in the acute phase. Can we go

Speaker 1

to the next one please, Dennis?

Operator

The next question is from the line of Robin Konoskis with Truist Securities. Please go ahead.

Speaker 20

Great. Thank you. I guess, 2 for me. So number 1, on REVLOVEL, we're hearing I'm just wondering about duration of therapy. We've got some anecdotal Some patients still feel a lot of fatigue and so they'll stop before the drug is actually working.

Speaker 20

So could you comment on like what you're seeing for duration of therapy and if And then second on DUCRA, I noticed that you have a topical formulation that's being developed. Can you talk a little bit about what your strategy might be there? Obviously, the topicals are becoming a growing market segment and maybe what different indications You might be pursuing. Thank you.

Speaker 2

Thank you, Chris. And then Sumit?

Speaker 5

Sure. So, I think you're right that a big focus area for us REBLAZYL continues to be on duration of therapy. The way we anticipate being able to drive that duration of therapy though is to continue to focus on dose What we're seeing right now is about 50% of patients are dose titrating. And remember, you need to have 2 dose titrations to get the benefit that you saw, in the clinical program in the real world setting. And so about 50% of patients are dose titrating with the first step and that compares to about 80%, which is what we saw on the clinical study.

Speaker 5

And if we can get that dose titration, Patients will get the full benefit of REBRISIL and we anticipate that that full benefit will translate into a longer duration of therapy. So I think that what you're hearing is consistent with the focus that we have for the continued growth of this product, continue to make sure that REBRISIL is the standard of care in the 2nd line on label The full benefit of Revlisil by focusing on appropriate dose titration, which we anticipate will increase the duration of therapy.

Speaker 8

Yes. And just very briefly on SOTIC-two, look, I think the overall potential for topical therapy It's being evaluated and we'll have to inform you in due course because landscape is continuing to evolve with multiple therapies coming for the milder population or mild Population, we already have the approval for moderate to severe plaque psoriasis and the mild population indication we'll need to continue to explore.

Speaker 2

So thanks everyone. In closing, with 9 new product launches in the last 3 years, I want to take a moment to reflect on all of the progress we have made. We have significantly de risked our portfolio with strong Clinical, commercial and financial execution, and we are well underway to transform our business into a more diversified and resilient company. I look forward To the coming catalysts ahead from our new product portfolio and our mid stage pipeline. With that, thanks again for taking the time to join our call today.

Speaker 2

And as always, our IR team will be available for any follow-up questions you may have. Thank you, and have a good day.

Operator

Thank you. That does conclude today's teleconference. We do appreciate your participation. At this time, you may now disconnect.

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