Q2 2021 Bristol-Myers Squibb Co Earnings Call

Okay.

Good day and welcome to the Bristol.

Operator: Good day and welcome to the Bristol-Meyers Squib 2021 Second Quarter Resorts Conference Call. Today's conference is being recorded, and at this time, I'd like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir. Thanks, Cathy.

On my script 2021 second quarter results Conference call. Today's conference is being recorded and at this time I'd like to turn the conference over to Mr. Tim Power.

Vice President of Investor Relations. Please go ahead Sir.

Thanks, Kathryn and good morning, everybody. Thanks for joining us this morning for our second quarter 'twenty.

Tim Power: Thanks, Catherine, and good morning, everybody. Thanks for joining us this morning for our second quarter 2021 earnings call. Joining me this morning with prepared remarks are Giovanni Kofourier, our board chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in the call today are Chris Burner, our chief commercialization officer, and Summit HeroWatt, our chief medical officer and head of global drug development. As you'll be aware, we've posted slides to bMS.com that you can use to follow along with David and GVany's remarks.

And in 'twenty, 1 earnings call. Joining me. This morning with prepared remarks are Giovanni for you Our board Chair and Chief Executive Officer, and David Elkins, Our Chief Financial Officer also participating on the call today are Chris Boerner, our chief commercialization officer, and someone here and what our Chief Medical Officer head of global drug development.

And you'll be aware, we've posted slides to.

To begin this dot com that you can use to follow along with for David and Giovanni's remarks, but before we get started I'll read our forward looking statements. During today's 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.

Tim Power: But before we get started, I'll read our forward-looking statements. During today's 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 not be relied upon as representing estimates at any future date. We specifically disclaim any obligation to update forward-looking statements even if for S-R. We'll also focus our comments on our non-gap financial measures Reconciliation of those non-gap financial measures to the most comparable gap measures is available at BMS.com. And with that, I'll hand it over to just one question.

And the company's SEC filings. These forward looking statements represent our estimates as of today and should not be relied upon as representing estimates as of any future date, we specific specifically disclaim any obligation to update forward looking statements. Even if our estimates change. We'll also focus for comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items.

Reconciliations of those non-GAAP financial measures for the most comparable GAAP measures are available at BMS dot com and with that and I'll hand, it over to Giovanni. Thank you, Tim and good morning, everyone I hope, you're all staying safe and healthy.

Giovanni Caforio: Thank you, Tim, and good morning, everyone. I hope you're all staying safe and healthy. Now, turning to slide four, let me start by saying I am very proud of our second quarter results and express my gratitude to our teams across the globe for their dedication and steadfast commitment to our patients. Through their work, we are continuing to make great progress to diversify and renew our portfolio and position Bristol-Squib for an even stronger field.

Now turning to slide for let me start by saying I am very proud of our second quarter results.

And express my gratitude to our teams across the globe for their dedication and steadfast commitment to our patients.

And would that work, we're continuing to make great progress to diversify and renew our portfolio and position and Bristol Myers Squibb for an even stronger future.

During the second.

Giovanni Caforio: During the second quarter, we delivered excellent results across the board, including strong sales growth due to solid commercial performance, positive clinical results in our mid- and late-stage pipeline, continued BD execution, and strengthened our financial position. The strength of our commercial execution this quarter was underscored by the performance of our key people, including the return of obdivote growth and the uptake of our new launch portfolio.

We delivered excellent results across the board, including strong sales growth due to solid commercial performance positive clinical results in our mid and late stage pipeline continued BD execution and strengthened our financial position.

The strength of our commercial.

Cost execution. This quarter was underscored by the performance of our key medicines, including the return of Opdivo to growth and the uptake of our new loan portfolio over.

Over the last 18 months, we launched 5 new medicines with significant potential and we are very encouraged by their performance.

Giovanni Caforio: Over the last 18 months, we launched five new medicines with significant potential, and we are very encouraged by their performance. Clinically, we continue to deliver on the potential of our pipeline with significant mid- and late stage clinical readouts and important regulatory actions across our therapeutic areas. The recent additions to our portfolio added diversification to our business and an opportunity to generate sustained growth over time. From a financial perspective, we saw double-digit growth for both the top and bottom lines, and we are reaffirming our full-year revenue and non-gap EPS gap.

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Clinically we continue to deliver on the potential of our pipeline with significant need and late stage stage clinical readouts and important regulatory actions across our therapeutic areas.

The recent additions to our portfolio added diversification to our business.

<unk>, 2 and opportunity to generate sustained growth over time.

From a financial perspective, we saw double digit growth for both the top and bottom line and we are reaffirming our full year revenue and non-GAAP EPS guidance, we continue.

Giovanni Caforio: We continue to maintain a strong balance sheet and generate significant cash flow, allowing us to advance our disciplined capital allocations. We remain focused on external business development opportunities to further strengthen our pipeline over the long term. This quarter we executed two licensing deals, an antitit specific antibody program with a genus and Morab 2O2, a folate receptor alpha ADC with ASI, both strategically aligned with our oncology pipeline. Overall, I am extremely pleased with our progress in the future. Turning now to our execution score card on slide 5.

And to maintain a strong balance sheet and general.

Significant cash flow.

Allowing us to advance our disciplined capital allocation strategy.

We remain focused on external business development opportunities to further strengthen our pipeline over the long term.

This quarter, we executed 2 licensing deals and anti digit bispecific.

Antibody program with a genus.

And more up to go to a folate receptor alpha ADC with ACI.

Both strategically aligned with our oncology franchise overall I am extremely pleased with our progress in the quarter.

Turning now to our.

It shouldn't scorecard on slide 5 we.

We have made tremendous progress year to date across our therapeutic areas.

Giovanni Caforio: We have made tremendous progress here to date across our therapeutic area. In oncology, we are strengthening our I. have returned Obdivow to growth through multiple clinical successes and excellent commercial execution. Earlier this year, we launched Obdevo in three additional indications, including first-line gastric cancer, where we are the first and only Ioha.

And collagen and we are strengthening our I O franchise and have returned opdivo to growth through multiple clinical successes and excellent commercial execution.

Earlier.

Excuse here, we launched Opdivo in 3 additional indications, including first line gastric cancer, where we added the first and only Io agent.

We anticipate additional launch opportunities and growth drivers for Opdivo to further accelerate the growth of the brand.

Giovanni Caforio: We anticipate additional launch opportunities and growth drivers for Obdivo to further accelerate the growth of the company. We also see opportunities to expand our IOP portfolio through the fixed dose combination of our lact-inhibitor, Relathlibib, with Okina. At ASCO last month, we announced impressive results for Relatlimab, potentially the third IOT therapy for BMS, building on our leadership in the field and expanding the durability of our friends We have a broad development program underway in I to benefit more patients over time.

We also see opportunities.

To expand our I O portfolio through the fixed dose combination of our a lag 3 inhibitor alright, lastly mode with Opdivo.

And as co last month, we announced impressive results for allowed to name and potentially the third high yield therapy for BMS building on our leadership in the field and expanding that.

The durability of our franchise.

We have a broader development program underway in I O to benefit more patients over time.

Moving to hematology, we received approval in the U S for 2 cell therapies, Rienzi and a beckman and demand for these products has been strong.

Giovanni Caforio: Moving to hematology, we received approval in the US for two cell therapies, Briani and Abak, and demand for these products has been strong. Physicians recognize the value of these treatments, and there is significant patient Building on existing indications for Brianzi, we announced the first ever positive phase three top line data in second line, transplant eligible, large B-cell lymphoma last year. This is an important result.

Physicians recognize the value of these treatments and there is significant for patient need.

Building on existing indications for brands, we announced the first day of a positive phase III top line data in second line transplant eligible and large b cell lymphoma last month.

This is an important result.

For the first time, we have shown that our cell therapy treatment is superior to a well established standard of care.

Giovanni Caforio: For the first time, we have shown that our cell therapy treatment is superior to a well-established standard of care. The positive results demonstrate that we can benefit patients early in their treatment. We look forward to sharing more details on these results later this year. We also have Iberdomide phase-data in-house, which we are very pleased with and look forward to discussing with health autonomy. The data is potentially the first step towards the establishment of a new backbone of treatment for multiple myeloma, offering a better option to benefit patients.

The positive results demonstrate that we can benefit patients early in their treatment journey.

We look forward to sharing more details on these results later this year.

We also.

A result.

<unk> phase II data and house, which we are very pleased with and look forward to discussing with health authorities.

The data are potentially the first step towards the establishment of a new backbone on treatment in multiple myeloma offering a better option to benefit patients.

We have made tremendous progress expanding our immunology franchise.

Giovanni Caforio: We have made tremendous progress expanding our immunology franchise. Lucravacetinib, a first-class selective tick 2 inhibitor, has the potential to be the oral agent of choice. We expect to launch this potential new medicine in psoriasis in the second half of 2020. We have initiated our phase three program in psoriotic arthritis, and we also look forward to phase two data in observative colitis later this year and in Crohn's disease and lupus in 2022, to further expand the potential of this molecule. We initiated our Phase 3 program for Sandacymab in Iosinophage.

So kind of a Sydney a first in class selective <unk> inhibitor has the potential to be the oral agent of choice.

We expect to launch this potential new medicine in psoriasis in the second half of 2022.

We have initiated our phase III program in psoriasis arthritis, and we also look forward to phase II data in ulcerative colitis later, this year and in Crohn's disease and lupus in 2020 due to further expand the potential of this molecule.

We initiated our phase III program for Syn <unk>.

You'll see nothing like esophagitis.

And last month in the U S. We launched zappos, yet in ulcerative colitis.

Giovanni Caforio: And last month in the US, we launched Ziposia in Alternative Collide. Finally, turning to CB, we are encouraged by the top line results we received this quarter for Milvexian, our factor 11A inhibitor. We look forward to presenting the data at a medical meeting later in the year. Additionally, we are preparing to launch Mavam for symptomatic, obstructive HCM in the US early next year.

Finally, turning to <unk>, we are encouraged by the topline results. We received this quarter for mill vaccine and our factor <unk> inhibitor.

We look forward to presenting.

Yeah at a medical meeting later in the year.

Additionally, we are preparing to launch from other Camden for symptomatic obstructive HCM in the U S. Early next year.

We are encouraged by the potential of these assets to strengthen the durability of our CV franchise.

Giovanni Caforio: We are encouraged by the potential of these assets to strengthen the durability of our CV franchise. In closing, on slide 6, our steadfast progress gives me great confidence that we are well positioned for growth, and we are rapidly advancing a new launch portfolio of first-class or best-class medicines across therapeutic care. We remain focused on driving in-light product performance, executing on our launches, advancing early and mid-stage pipeline opportunities, and continuing to take a disciplined approach to capital allocation. Our strong clinical performance further de-risks our launch portfolio. As a result, our confidence in our ability to deliver 20 to 25 billion in non-risk adjusted revenue in 2029 continues to increase.

In closing on slide 6.

And our steadfast progress gives me great confidence that we are well positioned for growth.

We are rapidly advancing our new launched portfolio of first in class or best in class medicines across therapeutic areas.

We remain focused on driving and light product performance executing on our launches.

To date advancing early mid and late stage pipeline opportunities and continuing to take a disciplined approach to capital allocation.

Our strong clinical performance further de risks our loan portfolio and as a result, our confidence and our ability to deliver the 20 to 20.

Julien and non risk adjusted revenue in 2029 continues to increase.

Our continued strong financial performance and balance sheet and enable us to diversify and strengthen our long term prospects.

Giovanni Caforio: Our continued strong financial performance and balance sheet enable us to diversify and strengthen our long-term business. As our sales force returns to the field and we welcome our remote teams back to the office, I'm excited by the opportunity to reconnect with our colleagues, stakeholders, and patients. I believe we have the strongest pipeline and launch portfolio in BMS's history, and I am very excited about our future. With that, I'll turn it over to David to walk you through the financials. David

And our sales force returns to the field and we welcome our remote.

5 teams back to the office I'm excited by the opportunity to reconnect with our colleagues stakeholders and patients I believe we have the strongest pipeline and launch portfolio and Bms's history, and I'm very excited about our future.

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

Thank you Giovanni and thank you all for joining our call today, let me start with our top line performance on slide 8 I'm very pleased to discuss our strong double digit growth this quarter driven by increased demand for key medicines across the globe.

David V. Elkins: Thank you, Giovanni, and thank you all for joining our call today. Let me start with our top-line performance on slide 8. I'm very pleased to discuss our strong double-digit growth this quarter, driven by increased demand for our key medicines across the globe. Looking at the first half of the year, which normalizes for most of the COVID-related buying patterns we experienced last year, commercial performance was strong, up 9% year over a year, or 7% excluding currency.

Looking at the first half of the year, which normalizes for most of the Covid related buying patterns, we experienced last.

And your commercial performance was strong up 9% year over year or 7% excluding currency. This robust performance demonstrates both our strong execution of our commercial teams as well as increased demand for our products I'll now provide additional color on the performance of our key brands and new launches starting with <unk> on slide 9.

David V. Elkins: This robust performance demonstrates both our strong execution of our commercial teams, as well as increased demand for our product. I'll now provide additional color on the performance of our key brands and new launches, starting with Eloquist on slide 9.

This.

This was another strong quarter for <unk> with global sales up 29% versus last year.

David V. Elkins: This is another strong quarter for Eloquist, with global sales up 29% versus last year. Second quarter growth benefited from a favorable year-over-year comparison as the prior year included the unwinding of COVID-related buying patterns. When looking at the first half to normalize for this dynamic, sales remained strong, up 18%.

Second quarter growth benefited from a favorable year over year comparison as prior year included the unwinding of Covid related buying patterns when looking at the first half to normalize for this dynamic sales remained strong up 18% and the.

U S. We saw strong demand with total prescription growth of 14% versus prior year, driven by market share gains, which continue to expect strong new to brand share growth for further translate to overall total prescription growth as a reminder, when we look towards the third and fourth quarters, we expect similar dynamics for the Medicare coverage gap and seen in previous.

David V. Elkins: In the U.S., we saw strong demand with total prescription growth of 14% versus prior year, driven by market share gains, which continue to expect strong, new-to-brand share growth for further translating to overall total prescription growth. As a reminder, when we look toward the third and fourth quarters, we expect similar dynamics from the Medicare coverage gap as seen in the previous year. Internationally, we had very strong demand across all key geographies, as we further gained share as the number one OAC in multiple markets, and we continue to see additional room to grow. Overall, we remain very pleased with the execution of Elicoists around the world and expect to continue to grow Elicus share within a growing class.

This year's <unk>.

Internationally, we had very strong demand across all key geographies as we further gain share as the number 1 or multiple markets and we continue to see additional room to grow overall, we remain very pleased with the execution of eloquence around the world and expect to continue to grow old co share within a growing class.

Now turning to Opdivo on slide 10, and let me start by saying, we're very pleased to deliver returned to growth this quarter up 16% versus last year, while COVID-19 recovery dynamics as well as approximately $40 million and U S inventory build contributed this quarter's growth. The brands performance was largely driven by strong demand for both our core.

David V. Elkins: Now, turning to Updiva on slide 10, let me start by saying we're very pleased to deliver a return to growth this quarter, up 16% versus last year. While COVID recovery dynamics, as well as approximately 40 million in U.S. inventory bills, contributed to this quarter's growth, the brand's performance was largely driven by strong demand for both our core and our newly launched indications in the U.S.

And our newly launched indications.

And the U S sales were up 13% year over year, as well as 14% sequentially driven by launches and lung RCC and our upper Gi cancers, which are all going well and lung shares and the low double digits with positive momentum and we are seeing use across all his.

David V. Elkins: Sales were up 13% year-year as well as 14% sequentially, driven by launches in Lung, RCC, and our upper GI cancers, which are all going well. In Lung, shares are in the low double digits with positive momentum, and we're seeing use across all histology. In RCC, our Updivo plus Cabo launch continues to do well. With Updivo, now the leading PD1, first-line reen, across both available regiments.

<unk> and RCC are up Devo, plus Cabo launch continues to do well with Opdivo and now the leading PD 1 first line renal across both available regimens.

And upper GI, we saw very strong start with Opdivo, plus chemo and first line gastric cancer with Checkmate <unk> 6 for 9 which reached 25% to 30.

David V. Elkins: In upper GI, we saw a very strong start with updiva plus chemo and first-line gastric cancer with checkmate 649, which reached 25 to 30% share in just a few months, based upon the strength of our data. The adjuvant suffogio launch, while still in the early days, is off to a great start. Overall, we see Upper GI as an important opportunity for Updiva based on the breadth of offered indications and the fact that Updivo is the only PD therapy approved for her two negative gastric cancer outside the U.

Solid share and just a few months based upon the strength of our data.

Sorry for Geo launch while still in early days, it's off to a great start overall, we see upper Gi is an important opportunity for opdivo based on the breadth of offered indications and the fact that Opdivo is the only PD therapy approved for her to.

2 negative gastric cancer.

Outside the U S. We had another strong quarter with sales up 13%, excluding the impact of foreign currency versus last year growth was primarily driven by demand of our new launches and lung and renal cancer.

David V. Elkins: We had another strong quarter, with sales up 13%, excluding the impact of foreign currency versus last year. Growth was primarily driven by demand for our new launches in lung and renal cancer. Results also benefited from a favorable comparison due to COVID-related impact last year.

<unk> also benefited from a favorable comparison due to COVID-19 related impact last year.

All in all we're very pleased with Opdivo performance and future growth outlook based on upon the positive momentum for our current lunches are future potential launches, including muscle invasive bladder cancer, and first line and Suffolk, Gilles as well as potential expansion opportunities from clinical trials that will read out over time.

David V. Elkins: All in all, we're very pleased with Obdiva's performance and future growth outlook based on the positive momentum for our current launches, our future potential launches, including muscle invasive bladder cancer and first-line esophageal, as well as potential expansion opportunities from clinical trials that will read out over time. Now turning to slide 11, regarding our inline multiple myeloma portfolio, Revermed was up globally, primarily driven by demand for In the U.

Now turning to slide 11 regarding.

Your line multiple myeloma portfolio.

<unk> was up globally, primarily driven by demand for triplet based therapies and increasing treatment duration and the U S. We are encouraged to see prescriptions nearing pre COVID-19 levels.

David V. Elkins: We are encouraged to see prescriptions nearing pre-COVID levels. Pomless global sales were up 15%, driven by continued strong demand for triplet-based therapies and use in earlier line. Now moving to our recent launches on slide 12, we continue to be very pleased with our new launches, beginning with Rebelsil, which generated $128 million in Q2 and increased 14% sequentially. As the bolus from the MDS launches continues to wind down, it is being replaced by underlying demand growth, as expected.

Global sales were up 15% driven by continued strong demand for triplet based therapies.

And our and end use and earlier lines.

Now moving to our recent launches on slide 12, we continue to be very pleased with our new launches, beginning with Red, Brazil, which generated $128 million and Q2 and increased 14% sequentially and.

The bolus from the Mds launches continue to wind down is.

And being replaced by underlying demand growth as expected, we continue to expect sustained growth and the second half of the year as we remain focused on treating new patients earlier in their treatment journey and ensuring they receive the most appropriate dose for sustained benefit.

David V. Elkins: We continue to expect sustained growth in the second half of the year as we remain focused on treating new patients earlier in their treatment journey and ensuring they receive the most appropriate dose for sustained benefits. Moving to Supposia, which generated $28 million in a quarter, the MS launch continues to progress well, where Suposia is the S1P of choice in terms of written prescriptions and where we continue to see high intent to prescribe metrics.

Moving to suppose you, which generate $28 million and the quarter. The MF launch continues.

The progress well, we're suppose yet is the <unk> of choice in terms of written prescriptions and where we continue to see high intent to prescribe metrics we.

We have also seen an acceleration and the conversion time from written prescriptions to commercially supplied product.

David V. Elkins: We have also seen an acceleration in the conversion time from written prescriptions to commercially supplied products. Looking forward, we continue to focus on establishing posia, not only as the S1P of choice but also the oral treatment of choice for MS. Beyond MS, we launched Supposia and ulcerative colitis in the US in early June.

Looking forward, we see we continue to focus on establishing symposia and non only as.

The S&P of choice, but also the oral treatment of choice for MFS.

Beyond MFS, we launched supposedly on ulcerative colitis, and the U S and early June while early and the launch we are very encouraged by physician receptivity to the product. So far our plan is to focus on stepwise process of building volume by establishing demand for this differentiated.

David V. Elkins: While early in the launch, we are very encouraged by physician receptivity to the product so far. Our plan is to focus on a stepwise process of building volume by establishing demand for this differentiated oral-like, biologic medicine while maximizing access over time. Turning to ANUREG, the launch is also going well, with double-digit demand growth over the prior quarter. We continue to expand the user base with physicians recognizing ANUREG as the first and only FDA-approved treatment for AML patients in first remission with a demonstrated OS benefit.

<unk> for like <unk>.

Biologic like medicine, while maximizing access over time.

Turning to on your Reg for launch is also going well with double digit demand growth over prior quarter. We continue to expand the user base with physicians recognizing on your AG is the first and only FDA approved treatment for AML patients.

And first remission with a demonstrated OS benefit.

Second quarter sales were impacted by reduced inventory driven by our transition from bottles to blister cards. However, based upon the strength of underlying demand trends, we expect to see sales rebound and the second half of the year remember that this is a new treatment segment, where it will take time to shape and establish.

David V. Elkins: Second quarter sales were impacted by reduced inventory, driven by our transition from bottles to blister cards. However, based upon the strength of the underlying demand trends, we expect to see sales rebound in the second half of the year. Remember that this is a new treatment segment that will take time to shape and establish on your egg as a maintenance treatment.

Stablish on erratic as a maintenance treatment.

Looking at each of these products internationally, we are encouraged to see how these launches are going and we look forward to driving growth through gaining access and reimbursement and additional markets over time.

David V. Elkins: Looking at each of these products internationally, we are encouraged to see how these launches are going, and we look forward to driving growth through gaining access and reimbursement in additional markets over time. Now, I'd like to turn to slide 13 and discuss cell therapy. Demand for our two new differentiated cell therapy products has been strong. Starting with Brionzi, we were pleased with our launch progress, with Q2 sales of 17 million, driven by strong execution and rapid site activation, with more than 65 sites activated to date.

Now I'd like to turn to slide 13, and discuss cell therapy demand for 2 new differentiated cell therapy products has.

And then strong starting with 3 on Z. We were pleased with our launch progress with Q2 sales of $17 million driven by strong execution and rapid site activation with more than 65 sites activated to date.

And messages around our differentiated profile and outpatient utilization are resonating well with high awareness among car T treaters.

David V. Elkins: Messages around our differentiated profile and outpatient utilization are responding well with high awareness among Carty treaters. Next, as it relates to Beckma, our first-class BCMA cartilage had sales of 24 million in a quarter, led by very strong demand.

And next as it relates to <unk>, our first in class D. CMA car T and sales of $24 million and the quarter led by very strong demand, we were able to leverage the site footprint beyond Z to accelerate site on boarding and advantage of launching 2 car T medicine and simultaneously based.

David V. Elkins: We were able to leverage the site footprint of Brianzi to accelerate site onboarding, an advantage of launching two CART medicines simultaneously. Based on the significant unmet demand and differentiated profile, we have seen robust demand for this product beyond our current capacity, and we are looking hard to increase capacity over time. Looking forward, we continue to see meaningful long-term potential for our cell therapy franchise across both Bionzi and Abechma, as evidenced by the recent demand we've seen.

Based on the significant unmet Dan demand.

And and differentiated profile, we have seen robust demand for this product the.

Beyond our current capacity and we are looking hard to increase capacity over time.

Looking forward, we continue to see meaningful long term potential with our cell therapy franchise and growth across both beyond Z and beckman as evidenced by the recent demand we've seen.

Now turning to the next slide a few points as we think about our launch portfolio. Overall first we are very encouraged with how each of these products are progressing at this point and the launch cycle.

David V. Elkins: Now turning to the next slide, a few points as we think about our launch portfolio overall. First, we are very encouraged with how each of these products is progressing at this point in the launch cycle. Together, they have already contributed $225 million this quarter and are approaching a billion-dollar-dollar run rate. Importantly, we view these products as having significant future potential.

Gather they have already contributed $225 million this quarter and are approaching a $1 billion run rate.

Accordingly, we review these.

And just having significant future potential this gives us great confidence and our ability to diversify and renew our portfolio as we look forward.

David V. Elkins: This gives us great confidence in our ability to diversify and renew our portfolio as we look forward. Now, let me take you through a few line items on our P&L on slide 15. Since we've already covered strong sales for the quarter, I'll focus on a couple other key line items. First, gross margin decreased versus the prior year, which is primarily due to foreign exchange and product mix. Operating expenses were higher than last year, particularly in MSNA, due to higher launch and pre-launch investments across therapeutic areas, as well as foreign exchange, which were partially offset by our realized synergies.

Now let me take you through a few line items on our P&L on slide 15.

Since we've already covered strong sales for the quarter I'll focus on a couple of other key line items first gross margin.

These products for east versus prior year, which is primarily due to foreign exchange and product mix.

Operating expenses were higher than last year, particularly in EM and <unk> due to higher launch and prelaunch investments across therapeutic areas as well as foreign exchange, which were partially offset by a realized synergies.

And remember that at the same time period last year.

David V. Elkins: Remember that at the same time period last year, our spend levels were lower than normal through the initial wave of COVID, and our effective tax rate was 16.9%, primarily driven by our earnings mix. Overall, non-gap EPS increased significantly year over year, primarily driven by our strong top-line performance. Now, switching gears to the balance sheet and our capital allocation on slide 16, our liquidity position remained strong with over $13 billion in cash in marketable securities and strong cash flow from operations of $3.1 billion in the quarter. Capital allocations and priorities remain unchanged.

And deep and levels were lower than normal due to the initial wave of COVID-19.

And if tax rate was 16, 9%, primarily driven by our earnings mix and overall non-GAAP EPS increased significantly year over year, primarily driven by our strong topline performance.

Now switching gears to the balance sheet and our capital allocation on slide 16.

Our liquidity position remains strong with over $13 billion, and cash and marketable securities and strong cash flow from operations of $3.1 billion and in the quarter.

Our capital allocation priorities remain unchanged during the quarter, we continued to strengthen our balance sheet, while renewing and diversifying our portfolio through business development.

David V. Elkins: During the quarter, we continue to strengthen the balance sheet while we're renewing and diversifying our portfolio through business development. Giovanni mentioned we executed two deals during the quarter that both complement and diversify our oncology portfolio with the genus and E-Side. As it relates to continued debt reduction, our $4 billion tender offer and an additional $1.5 billion in maturities in the first half of the year demonstrate our commitment to a strong investment-grade rating.

Bonnie mentioned, we executed 2 deals during the quarter that both complement and diversify our oncology portfolio with the genus and ESI.

As it relates to continued debt reduction our $4 billion tender offer and additional $1.5 billion and maturities and the first half for the year demonstrate our commitment to strong investment grade rating as it relates.

<unk> to our share repurchases of the planned buyback for 3 to 4 billion. This year, we have already bought back $3 billion to date and will remain opportunistic as the year progresses.

David V. Elkins: As it relates to our share repurchases, of the planned buyback of 3 to 4 billion this year, we have already bought back 3 billion to date and will remain opportunistic as the year progresses. Now turning to our 2021 guidance on slide 17, following this course performance, we are reaffirming our top and bottom line non-gap guidance for the year, which reflects significant growth over last year. From a full-year revenue perspective, we continue to expect growth in the high single digits.

Now turning to our 2021guidance on slide 17. Following this quarters performance, we are reaffirming our top and bottom line non-GAAP guidance for the year.

Year, which reflect significant growth over last year.

From a full year revenue perspective, we continue to expect growth and the high single digits in terms of phasing for the remainder of the year due to electricity coverage GAAP and I'm unwinding of Opdivo inventory that I noted earlier, we expect Q3 global revenues to be similar to Q.

David V. Elkins: In terms of phasing for the remainder of the year, due to Elyss's coverage gap and on the winding of Updevo inventory that I noted earlier, we expect Q3 global revenues to be similar to Q2. However, we are encouraged by the strength in the business and expect full-year sales at the higher end of our guidance. We have updated our gross margin assumption to 80% for the full year, primarily due to product mix and the impact of foreign exchange.

2 however, we are encouraged by the strength and the business and expect full year sales at the higher end of our guidance.

We have updated our gross margin assumption for 80% for the full year, primarily due to product mix and the impact of foreign exchange.

Moving to operating expenses, we are maintaining our full year guidance on M. S N a.

David V. Elkins: Moving to operating expenses, we are maintaining our full-year guidance on MSNA of a low single-digit increase and on R&D of a mid-single-digit increase. In terms of phasing for OPEX, we expect it to increase quarter over quarter at a similar rate to the first half of the year. Based on that and the strength of the business, we are reaffirming non-dap diluted EPS of $7.35 cents and $7.55 for 2021. This quarter, we remain pleased not just with our performance but also with the considerable progress we made in executing our launches and advancing our pipeline. I'll now turn to call back over to Tim and Giovanni for Q&S. David. Catherine, could we go to our first question, please?

Low single digit increase and on R&D of mid single digit increase in terms of phasing for Opex, we expect it to increase quarter over quarter at a similar pace to the first half of the year.

Based on that and the strength of the business. We are reaffirming non-GAAP diluted EPS of $7.35, and $7.55.

For 2021.

This quarter, we remain pleased not just with our performance, but also with the considerable progress we've made and executing our launches and advancing our pipeline.

I'll now turn the call back over to Tim and Giovanni for Q&A.

Alright, Thanks, David Katz and can we go to our first question. Please.

Thank you we'll take the first question from Chris Scott J P. Morgan.

Operator: Thank you. We'll take the first question from Chris Scott at J. Morgan. Please go ahead.

Please go ahead.

All right great. Thanks, so much for the questions.

Chris Schott: Great, thanks so much for the questions. I guess the first one for me was on Opdivo, and maybe just a two-parter here.

The first 1 for me was on Opdivo and maybe just a 2 parter here.

Chris Schott: First of all, good to see that return to growth. But what are you seeing for Updivo in terms of the COVID impact? I know you've talked in the past about some lingering headwinds, but I just want to get the latest as we've moved through June and July.

First of all good to see that return to growth, but what are you seeing for opdivo in terms of the Covid impact I know you've talked.

And the past about some lingering kind of headwinds, especially to get the latest as we've moved through June and July is that business still depressed or are we starting to see a more normalized environment and and the second 1 and up to Evo was just a little bit more color on the rollout and gastric and terms of where we stand today in terms of penetration rates and then my final question was just on the competitive environment.

Chris Schott: Is that business still depressed, or are we starting to see a more normalized environment? And then the second one on Updevo was just a little bit more color on the rollout in gastric in terms of where we stand today in terms of penetration rates. Then my final question was just on the competitive environment for Mavicle, in light of some of the recent competitor data. I just want to see, kind of more broadly speaking, has there been any change in view or confidence in that asset at all? Thanks so much.

And I are meant for Maverick Hampton and in light of some of the recent competitor data I just wanted to see kind of more broadly speaking has there been any change and and view our confidence and that asset at all thanks. So much.

Thank you, Chris Let me, let me ask Chris Burner to answer your question about Opdivo and then some it will make some comments on.

Chris Boerner: Thank you, let me ask Chris Burner to answer your question about Obdivo, and then Summit will make some comments on the profile of Mavac. Sure, thanks for the question, Chris. So let me start with the COVID impact. We have seen a recovery in the I.O. market really coming out of Q1 and into Q2, and I would say that is a recovery on multiple parameters. First, we've seen new patient claims. While they still lag pre-COVID levels, they've certainly improved quarter over quarter. IO demand continues to recover versus pre-COVID levels and, in fact, grew about 5% quarter over quarter.

On the profile of automatic Hampton sure. Thanks for the question, Chris So let me start with the Covid impact we have seen a recovery and the Io market really coming out of Q1 and into Q2 and I would say that is a recovery on multiple parameters for.

And we've seen new patient claims while they still lag pre COVID-19 levels, they have certainly improved quarter.

Order over quarter Io demand continues to recover versus the pre COVID-19 levels and in fact grew about 5% quarter over quarter and and importantly, we've seen an increase and in person and engagement oncology still lacks other therapeutic areas, but increasingly our field teams are able to engage lie with with our customers and that's going to be really important.

Chris Boerner: And importantly, we've seen an increase in in-person engagement. Oncology still lacks other therapeutic areas, but our field teams are increasingly able to engage live with our customers. And that's going to be really important, given the competitive nature of a number of these markets, like first-line lung cancer. So I would say, in general, COVID continues to be dynamic, really, across markets, and certainly that's true in oncology. But I would say there's been a general improvement as we've exited Q1 and into Q2. As for how things are going in gastric cancer, I would say the gastric launch continues to go really well. Very well,

And given the competitive nature of a number of these markets like first line lung cancer. So I would say and general Covid continues to be dynamic really across markets and certainly that's true and oncology, but I would say and theres been a general improvement as we exited Q1 and into Q2 as for how things are going and gastric cancer I would say.

Important to gastric launch continues to go really very well and as you know we have multiple indications now and gastric cancer and I would say that in general the first line metastatic.

Chris Boerner: As you know, we have multiple indications now for gastric cancer, and I would say that, in general, the first line, metastatic launch, is going quite well. Our share is roughly 35 percent, and that's being led really by the gastric segment where we see really good utilization of Obdivo plus chemo in both GEJ and EAC as well. We're seeing use across all CPS levels. As you would expect, the majority is in the greater than 10 percent.

Launch is going quite well our share is roughly 35% that's being led really by the gastro segment that we see really good utilization of Opdivo.

Say chemo and both G J and EAC as well and we're seeing use across all Cps levels. As you would expect the majority is and the greater than 10%, but we are seeing strong uptake and less than 10% as well and I would say execution has been very good and in fact, we have the number 1 share of voice and we continue to build new trials, which is important at this stage and the launch.

Chris Boerner: But we are seeing strong uptake in less than 10 percent as well, and I would say execution has been very good. And in fact, we have the number one share of voice, and we continue to build new trialists, which is important at this stage in the launch. So overall, we're very happy with the performance and the guys.

And so overall very happy with the performance and gastric.

And Chris I'll, just thinks there's and Chris.

Samit Hirawat: And Chris, thanks, Chris, Chris, Chris, I'll just take on the Marva Campton question that you asked, and I guess the question is emerging from the Redwood data that were recently shared in the press. And while it's truly an apples to oranges comparison, I would say that we don't see a differentiation as might have been perceived. And the reason for that is, if you look at it from our efficacy perspective, the measures were at a different time point, first of all, 10 weeks versus a 30-week trial for Explorer.

Chris I would just take on the Marvel and question that you asked and I guess the question is emerging from the Redwood data that for recently shared through our press release.

And while it's truly an apples to oranges.

We don't see a differentiation as might have been perceived and the reason for that is if you look at it from a efficacy perspective. The measures. We're at a different time 0.1st of all 10 weeks versus the 30 week trial for explorer.

Secondly, the differences.

Samit Hirawat: Secondly, the differences or the primary endpoints that were measured were at rest and with the Valcelva maneuver in the Redwood trial versus doing exercise. So if you were to compare those apples to apples, there would be no differentiation.

On the.

Primary endpoints that were measured at rest and with about settlement and we're in the Redwood trial versus doing exercise. So if you were to compare those apples to apples that is no differentiation that we see from a safety perspective as well when we talk about decrease and the ejection fraction.

Samit Hirawat: From a safety perspective as well, when we talk about decreasing the ejection fraction, if you start with a higher ejection, of course, you will not see as big of a decrease below 50%, which was the case in the Redwood trial. We had patients enrolled in our explorer study with a lower rejection fraction of 55% or lower, and therefore, when we compare apples to apples again, in fact, if anything, we could turn out to be better.

And if you start with the higher ejection fraction of course, you will not see as big of a decrease below 50%, which was the case and the Redwood trial, we had patients enrolled and our explorer study with a lower ejection fraction of 55% or lower and therefore, when we compare apples to apples again in fact.

If anything we could turn out to be better at the end of it all I would say we need to wait to see the data and the phase III trials for the competitor molecule. We already have our phase III data, we've already submitted and look forward to bringing it to patients and the Purdue for data in January.

Samit Hirawat: At the end of it all, I would say we need to wait to see the data from the phase three trials for the competitor molecule. We already have our phase three data. We've already submitted it, and we look forward to bringing it to patients with the PDFA data. Thank you so much.

Great. Thanks.

If we go to our next question please.

Operator: Thank you. We'll now take the next question from Jeff Meacham at Bank of America. Please go ahead.

Okay.

Thank you we will now take the next question.

Geoff Meacham with Bank of America. Please go ahead.

Geoff Meacham: Hey, guys, thanks for the question. Congratulations on the quarter. I've just had a few.

Hey, guys. Thanks for the question and congrats on the quarter I just had a few on the cell therapy launches you guys had a good quarter out of the gate. So I wanted to.

Geoff Meacham: On the cell therapy launches, you guys had a good quarter out of the gates. I wanted to ask you what the drivers are for the next few quarters. Is it signing out more accounts?

Summit with the with the drivers and next few quarters or is it signing up more accounts and establishing better reimbursement and and maybe just help us with kind of if you had any manufacturing.

Geoff Meacham: Is it establishing better reimbursement? And maybe just help us with kind of if you had any manufacturing bottlenecks. I mean, you guys have talked about that previously. And then on Duke Kravocitnib, maybe just help us with kind of how you were thinking about what success looks like in ulceropoietin colitis and also any additional thoughts that you've had.

Next I know you guys have talked about that previously.

And then on on do crab is sitting there.

Maybe just help us with kind of how you were thinking about.

Ask you what success looks like and ulcerative colitis.

And also any additional thoughts that you've had I know theres been a lot of discussion about potential labeling and and differentiation versus Jackson and maybe as you've had time to digest. The recent data and maybe just give some updated thoughts on that thank you.

Geoff Meacham: I know there's been a lot of discussion about, you know, potential labeling and differentiation versus Jackson, and maybe as you've had time to digest the recent data, I may just give some updated thoughts on that. Thank you. Thank you, Jeff.

Thank you, Jeff So let's start for cell therapy, Let me just say first really exciting.

Giovanni Caforio: So let's start with Cell Therapy. Let me just say first, really exciting. And the launch is off to a great start. It really demonstrates that our decision to invest in this technology and the differentiated nature of our two products is paying off. There is a lot of excitement.

And the launch is off to a great start and it really demonstrates that our decision to invest and this technology.

And a differentiated net nature of our 2 products and space paying off there is a lot of excitement.

And so let me ask Chris to give you more and more and more details and then summit will give you his perspective on other chronic setting and credit yeah. So I would just reiterate what Giovanni just said the commercial and medical launches for both products continues to be very strong we've seen good execution across the teams on importantly for both.

Chris Boerner: Let me ask Chris to give you more details, and then Summit will give you his perspective on Dukrovac. Yeah, so I would just reiterate what Giovanni just said: the commercial and medical launches for both products continue to be very strong. We've seen good execution across the teams.

Chris Boerner: Importantly, for both A Bechma and Breonzi, the profiles for these products are responding well with customers, in the case of Beckma as a first-in-class BSEMA targeted cell therapy, and for Breonzi as a best-in-class. One of the things we've seen across both products is their significant unmet need. That's particularly true in the case

Beckman and brands either profiles for these products are resonating well with customers and the case of a back and the as a first in class B CMA targeted cell therapy and for <unk> Z as a best in class 1 other things we've seen across both products that there is significant unmet need that's particularly true in the case of a back and then just given the fact that there are.

Chris Boerner: case of BECMA, just given the fact that there are no other opportunities in many cases for these patients. And as a result, we've seen very strong demand for both products. What I would say is for Brionzi, the focus continues to be on ensuring the sites know how to manage these patients well, continuing to sell the best in class profile that we have with Brionzi. And we're increasingly seeing interest in patients being referred to clinical trial sites, so we're managing that well with Brionzi.

And our opportunities in many cases for for these patients and as a result, we've seen very strong demand for both products. What I would say is for Brianti. The focus continues to be on ensuring that sites know how to manage these patients well continuing to sell the best in class profile that we have with brands and we're increasingly seeing interest and patients.

No other clinical trial sites, so we're managing that well with <unk> for <unk> I would say the focus there continues to be engaging with customers around manufacturing capacity as we had said previously.

Chris Boerner: For BECMA, I would say the focus there continues to be engaging with customers around manufacturing capacity. As we had said previously, this is a space where, because of the significant unmet need and because we are the first BCMA targeted cell therapy in the space, the demand for this product has outstripped our current capacity to manufacture. What I would say is that the sole focus that we have there is steadily increasing manufacturing capacity.

This is a space where because of the significant unmeet unmet need and because we are the first be CMA targeted.

Being worth therapy and this space on.

The demand for this product has outstrip our current capacity to manufacture what I would say is the sole focus that we have there is on steadily increasing manufacturing capacity, we have a very strong team. That's in place focused on this we're engaging obviously internally and externally with third parties, including regulator.

Chris Boerner: We have a very strong team that's in place focused on this. We're engaging, obviously, internally and externally with third parties, including regulators, to increase the number of slots that we have available for patients. And that's going to be the main focus on that product for the coming month. Thanks, and maybe I can take on the Dukra question in terms of alternative colitis for Dukra. As you know, with a tick two inhibitor, we know the downstream effect is an inhibition of IL12 and IL 23.

And to increase the number of slots that we have available for patients and that's going to be the main focus on that product for the coming months.

Thanks, and maybe I can take on the <unk> question in terms of ulcerative colitis for Ducommun as you know.

With a tick 2 inhibitor, we know the downstream effect and the inhibition of IL.

2 other and IL 23 pathway.

These mechanisms are already proven to be effective and ulcerative colitis and so we are truly looking forward to seeing the data at the end of the year from our phase 2 study, where we will get to see the induction data comparing do cover versus placebo. So we know what success would look like because that has proven mechanisms.

Chris Boerner: These mechanisms are already proven to be effective in ulcerative colitis, so we are truly looking forward to seeing the data at the end of the year from our phase two study, where we will get to see the induction data comparing dukeva versus placebo. So we know what success would look like because there are proven mechanisms out there. We know what efficacy we would be looking for in a phase two study to initiate our phase three program.

And we know what the efficacy that we would be looking for and a phase II study to initiate a phase III program and the good news is we also have the Crohn's disease study ongoing which will read out and next year. So a broad program that we will be able to take forward to really get the phase III data to impact the second second half of the decade following the deposit launch right.

Chris Boerner: And the good news is we also have the Crohn's disease study ongoing, which will read out next year. So a broad program that we will look at and be able to take forward to really get the phase three data to impact the second half of the decade following the Ziposia launch right now. Can we go to the next question, please?

Now and that disease.

Thanks, Katherine can we go to the next question. Please.

Operator: Thank you. We'll now take the next question from Terence Flynn at Goldman Sachs. Please go ahead.

Thank you we'll now take the next question from Terence Flynn with Goldman Sachs. Please go ahead.

Hi, great. Thanks for taking the questions. Congrats on the progress of the new products, maybe 2 for me just 1 follow.

Terence C. Flynn: Hi, great, thanks for taking the questions. Congratulations on the progress of the new products. Maybe two for me.

Terence C. Flynn: Just one follow-up on Beckmo. I was wondering if you could give us any guidance in terms of the number of patients you can currently serve from your manufacturing facility that you have right now and then remind us of timing to bring on additional capacity. Again, I think you guys are building out some further capacity there, so any update on timing. And then a question for Summit on the Factor 11A program. I know we talked about this last month.

And then a back mode and I was wondering if you could give us any guidance in terms of number of patients. You can currently serve from your manufacturing facility that you have.

Right now and then remind us of timing to bring on additional capacity is again I think you guys are building out some further capacity there so any update on timing and then a question.

Question for summit on the factor 11 day program.

And we talked about this last month do you have the data in house, but any more perspective on how to think about starting up on a trial on the afib setting or is that really contingent on seen data from a second phase II trial. Thank you.

Terence C. Flynn: You have the data in-house, but any more perspective on how to think about, you know, starting up a trial in the AFIB setting, or is that really contingent on seeing data from the second phase two trial? Thank you.

Chris Boerner: Thanks, Chris, Chris, do you want to start on Abechma? Sure.

Thanks, Terence Chris do you want to start on on.

Sure. So on so as I said and the previous question. Our focus continues to be to increase the available capacity that we have for this product.

Chris Boerner: So, as I said in the previous question, our focus continues to be to increase the available capacity that we have for this product. As I think we've discussed previously, we had increased the number of thoughts that were available for patients until August, and so we were able to increase to meet the demand in August at the same time. We continue to see a shortage of vectors, which is something that's been affecting multiple health therapy products, and so we're keeping an eye on that.

And I think we've discussed previously.

We had increased the number of slots that were available for patients to August and so we were able to increase.

2.

To meet the demand and in August at the same time, we continue to see a shortage of vector that that is something thats been affecting multiple cell therapy products and so we're keeping an eye on that and what I would say our parents is that the situation.

Chris Boerner: And what I would say, Terence, is that the situation on vector supply continues to be fairly dynamic. And so with respect to wind supply, it will ramp significantly, I would say, rather than put out a date that would likely shift, I'll just say that this continues to be a top priority for us. Our sole focus continues to be on increasing supply to meet the near-term anticipated commercial demand, and then, obviously, we have a longer-term focus on ensuring more stable, long-term supply for Vector that would be available to support both of these products. But that's where the situation sets for about.

On vector supply continues to be a fairly dynamic and so with respect to win and supply.

And we'll we'll.

Ramped significantly I would say that rather than put out a date that would likely shift I'll. Just say that this continues to be a top priority for us our sole focus continues to be on increasing the supply to meet the near term anticipated commercial demand and then obviously, we have a longer term focus on ensuring more stable long term supply for vector that would be available to.

To support both of these products, but on.

And that's where the situations such for Beckman.

And tenants for VIX in or factor 11 day inhibitor and what I would say is that what we've seen thus far from the total knee replacement study. We are very pleased with that the trials showed exactly what we anticipated to show and we do believe.

Chris Boerner: And Terence, for Milvexian or Factor 11A inhibitor, what I would say is that what we've seen thus far from the total knee replacement study, we are very pleased. The trial showed exactly what we anticipated it would show. And we do believe, along with our collaborator Janssen, that we do need the second trial data, as together the two trials will form the basis for the clinical development plan. Remember, in the first study, in the TKR study, we only had about two weeks of dosing with a single agent, Factor 11A inhibitor.

Along with our collaborator Janssen that we do need the second trial data as.

Collectively the 2 trials will form the basis for the clinical development plan and a member in the first study and the <unk> study, we only have about 2 weeks of dosing with a single agent factor <unk> inhibitor, whereas in the second trial and the.

Chris Boerner: Whereas in the second trial, in secondary stroke prevention, we have the background therapy of doublet anti-platelet therapy as well, for up to three months of dosing. And so that longevity will be important to understand the overall safety profile, and that will obviously then be able to go into the Phase 3 program, not only just AF, but we are thinking of other summits, Catherine. Go to the next question.

Believe other secondary stroke prevention, we have the background therapy of doublet anti platelet therapy, as well with up to 3 months of dosing and so that longevity and will be important to understand the overall safety profile and that will obviously, then and be able to go into phase III program, not only just <unk>, but we're thinking of.

Patients as well.

Okay.

I guess I'll, let Katherine go to the next question. Please.

Operator: Thank you. We'll now take the next question from Andrew Baum at City. Please go ahead.

Thank you we will now take the next question Andrew Baum at Citi.

Please go ahead.

Andrew Baum: Thank you. First, we don't hear so much about your earlier generation of immunoncology programs before the transaction. There are a number of papers out on the importance of TREG E EACC and ADCC, part of the CTLA4 mechanism, and I know you have your A2-Coculated molecule in a fairly large trial.

Thank you couple of questions for.

We didn't hear so much about your earlier generation.

Other income of.

Immuno oncology programs before the transaction.

And a number of papers out on the importance of T Reg depletion and HCC.

The <unk> for mechanism and I know you have you on AC costly and molecule and a fairly large trial.

Andrew Baum: Could you update us on when we might expect the CETM results and just your general level of enthusiasm for that approach for the validated type? And then second, in light of the Adderhelm approval and particularly the biomarker, how is this thinking affecting you over your efforts in your neurodegenerative disease? Obviously, you've been invested historically in that space, but this is the catalyst for Bristol to reenter that second.

Could you update us on when we might expect.

<unk> and results and just your general level of enthusiasm on that approach for a validated target and then second and lines of the other helm approval on.

And particularly the biomarker and.

This thinking.

And you of your assets and your degenerative disease, obviously, you've been investing historically.

Directly and that space is as a catalyst for Bristol to reenter that segments.

Giovanni Caforio: Thanks, let me make just a couple very high-level comments, and then Summit will take both of your questions. So, first of all, with respect to I.O., I think we're really excited about the opportunity to launch our third IO agent, which is Relatlimab in Metastatic Melanoma, and that really shows how we are progressing and extending, in fact, the strength of our IO franchise.

Thanks, Andrew Let me make just a couple of very high level comments and then some it will take both of your questions. So first of all with respect to I O. I think we're really excited about the opportunity to launch a third.

And I O agent potentially.

Soon which is around the Ottawa and luckily might be and metastatic melanoma and that really shows how we are progressing and and and and extending in fact, the strength of our I O I O franchise with respect to the CNS again summit will will address your your.

Giovanni Caforio: With respect to CNS, again, Summit will address your question in more detail. From my perspective, what I'd like to say is this is a research area that we committed to, in fact, as part of the Selgin Research Strategy a few years ago, and we are really excited to have a number of early programs that are continuing to advance. It's primarily driven by a really interesting set of external partnerships, so let me ask Summit to give you more detail. on both of those topics.

Your question on anymore or are you more detail from my perspective I'd like to say is these are this is a research area that we committed to in fact as part of the Celgene and research strategy. A few years ago. We are really excited to have a number of early programs. There are continuing to advance is primarily driven by a really interesting set of external partners.

And on ships. So let me ask Simon to give you more detail on both of those topics Andrew I think from a C. T. L. A for perspective as you know, we have 3 molecules and developing and the backup the CTO for pro body and non because they didnt because they are molecules the true.

Samit Hirawat: Andrew, I think from a CTLA-4 perspective, as you know, we have three molecules in development for the backup, CTLA4, pro-body, non-phycoslated, and fecoslated molecules. The trials are ongoing, as you said, very well, and we are actually looking forward to seeing the data towards the end of the year and the early part of next year. That will certainly pave the way for new trials looking at combinations with our pipeline, with Obdivo as well as other molecules. As you just heard from JVAN, we have Rylatlamab and then new additions to our pipeline with Tidgets as well as the ADC that we recently acquired.

Those are ongoing as you said very well and we are actually looking forward to see the data towards the end of the year as well.

Well as and early part of next year that will certainly pave the way for new trials looking at combinations with our pipeline with Opdivo as well as other molecules as you just heard from you from Giovanni do you have for that.

And then new additions to our pipeline with tickets as well as with the ADC that we use.

And the acquired those clinical development plans are being formulated and appropriate indications on it yet to be chosen based on the activity that we will see from these trials.

Samit Hirawat: Those clinical development plans are being formulated, and appropriate indications are yet to be chosen based on the activity that we will see from. To your second question on the recent approval for Alzheimer's disease and then how to see that data and what to do with that, we do believe, as Giovanni said, that our focus on neurology and neurodegenerative disease has continued to be there, and we'll continue to increase it from there onwards. The way we look at that data is now that the threshold has been set from a regulatory perspective; it was hard to gauge before what endpoints to really shoot for and what the threshold was.

To your second question on the recent approval on Alzheimer's disease, and then how to see that data and what to do with that.

We do believe as Giovanni said that R. R.

Our focus on on neurology and neuro degenerative disease as continued to be there and we'll continue actually to increase from there onwards. The way we look at that data is not at that threshold has been set from a regulatory perspective. It was hard to gauge before what endpoints are really shoot for and what was the threshold now that we know what the threshold is.

Samit Hirawat: Now that we know what the threshold is, it is probably going to be better or easier to develop studies because there is a regulatory path forward. As you recall, we recently announced our collaboration with Proteina and are looking forward to making our way into clinical studies with that inhibitor, which has a differentiated mechanism that we'll be able to take forward. More to follow in. Summit. Catherine, can we go to the next question, please?

And now probably going to be better or easier to develop studies because there is a regulatory path forward as youll recall, we recently had announced our collaboration with Bettina and looking forward to make our way into the clinical studies for that Tom.

Inhibitor with <unk>.

<unk> differentiated mechanism.

It is going to be able to take forward more to follow in the future.

Thanks, Katherine can we go to the next question. Please.

Operator: Thank you. We'll now take the next question from Seamus Fernandes at Guggenheim. Please go ahead.

Thank you we will now take the next question from Seamus Fernandez at Guggenheim. Please go ahead.

Oh, great. Thanks for the question. So first on and Beckmann, just wanted to get a better sense of.

Seamus Christopher Fernandez: Oh, thanks for the question. First, on Beckma, just wanted to get a better sense of, you know, where capacity could potentially go, and if there's any visibility on the vector dynamics, you know, and perhaps when that might release. Is that entirely, you know, reflective of, is that more reflective of the situation in terms of vector manufacturing and capabilities at Bluebird? Or is it a global market dynamic, you know, associated with this sort of use of nucleic acid targeted therapies?

Where capacity could potentially go to.

And if there's any visibility on the vector dynamics.

<unk>.

And perhaps when that might release is that entirely.

Reflective of.

Is that more reflective on the.

Situation in terms of vector manufacturing and capabilities at Bluebird or is it a global market dynamic associated.

And with that sort of use of nucleic acid.

Targeted therapies, just wanted to get a sense of.

Seamus Christopher Fernandez: Just wanted to get a sense of what the impacts are there. And then, what would the hope for expansion of capacity capabilities be in 2022 relative to 2021? Do you have any sense of timing improvement for the vectors as it relates to Beckma?

What the impacts are there.

And then what would the hoped.

For expansion of capacity.

Capabilities be and 2022 relative to 2021 do you have any sense of timing improvement for.

Perfect for.

Other vectors as it relates to our back Mark.

Seamus Christopher Fernandez: Second question, just wanted to, you know, get a little bit of a better sense of the ongoing strategy. The number of targets that you guys are pursuing specifically in multiple myeloma, you know; you have a huge number of programs ongoing there. I just wanted to have you guys talk a little bit about prioritization in that regard and where you see the most opportunity for new products in that space, whether it be the cell mods, you know, or, specifically, the T-cell Engager. You know, just wondering where we're going to see some acceleration in those programs there. Thanks so much.

Second question just wanted to.

Get a.

For the better sense of the ongoing strategy on the.

And the number of targets that you guys are pursuing specifically and multiple myeloma.

You have a huge number of programs on going there just wanted to have you guys talk a little bit about prioritization.

A little bit in that regard and where you see.

The most opportunity for new products and that space, whether it be some odds.

<unk> or.

Or by specific.

T cell engaged or.

Just wondering where we're going to see some acceleration and those programs there. Thanks so much.

Thanks, Seamus so on and on our back come out I mean, just say to your question.

Giovanni Caforio: Thanks, so on a backwards, ma, let me just say to your question, you know, the supply chain of, globally, the supply chain for vectors is very dynamic. We don't look at this as a specific issue but rather a really complex issue across the industry. I'll ask Chris whether there's anything he wants to add, and then we'll talk with Summit about our strategy for multiple myeloma. As I mentioned, I'm excited to have the Aberdomide Phase 2 days. in-house, which is a really important step forward for us. Chris, anything to add on a Beckma?

Shane of globally, the supply chain for vector.

It's very dynamic and we don't look at this as a as a specific issue, but rather a really complex issue across the industry I'll ask Chris to whether.

And anything he wants to add.

And then we'll talk with summit about our strategy and multiple myeloma as I mentioned excited to have the Alberta made a phase II data in house, which is a really important.

Net forward for us Chris anything to add on the back on that yeah. The only thing I would add is shameless just sort of 2 dynamics at play with it back.

Chris Boerner: Yeah, the only thing I would add is, Shamish, there are sort of two dynamics that play out with Bekbo. One is the significant demand that we're seeing in the marketplace, which is, I would say, a function of the fact that there's significant unmet need. The profile of Bechma is very strong, and the fact that you've seen a bolus of patients who have been really reserved for these therapies, this therapy in particular when it launched, so there's very strong demand. And so obviously, there's an internal focus on increasing our ability to supply that demand, which has exceeded the supply that we anticipated having to deliver to the marketplace.

Whether there's and there's a significant demand that we're seeing and the marketplace.

Which is I would say a function of the fact that there is significant unmet need the profile of a beckman is very strong and the fact that you've seen a bolus of patients who have been really reserved for these therapies and this therapy in particular when it launched so theres various.

Very strong demand and so obviously theres and internal focus on increasing our ability to supply that demand, which has exceeded the supply that we anticipated and having to deliver into the marketplace. The second thing I would say is this broader global issue around vector supply that's something we've been hearing from customers that's impacting multiple cell therapy.

Chris Boerner: The second thing I would say is this broader global issue around vector supply. That's something we've been hearing from customers that's impacting multiple cell therapy products. And obviously, as we think about our strategy, not only for the end of this year, but really as we get into next year, our focus is going to be ensuring a more stable long-term supply of vectors.

The <unk> and obviously as we think about our strategy not only for the end of this year, but really as we get into next year. Our focus is going to be ensuring a more stable long term supplier vector and.

Samit Hirawat: And that's something we'll be happy to update on as we have more details. And Seamus, from a multiple myeloma perspective, we certainly remain the leaders in multiple myeloma and want to continue to progress on that path. And we have a very strong pipeline, as you very well mentioned.

That's something we'll be happy to update on and as we have more details to provide it.

And Seamus for them on multiple myeloma perspective, we certainly remain the leaders.

<unk> and multiple myeloma and want to continue to progress on that path and we have a very strong pipeline as you very well mentioned there are 3 pillars for the multiple myeloma strategy number 1 the cell mods and we intend to use these cell module for future backbones, replacing the image and are currently out there.

Samit Hirawat: There are three pillars to the multiple Miloma strategy. Number one, the cell mods. And we intend to use these cell mods as the future backbones replacing the image that are currently, In that regard, strategy is two-pronged. One is a single agent entering in the late line of therapy. The first data we've seen with iberdermide already, and then next year we'll see the data for CC480, the second cell mod, which is more and then progressing them further up the line in terms of combinations, you might see on KunTrile.gov, we've already announced and are initiating a trial in patients who have received two to three prior lines of therapy as a combination of iberdomyte with diatomomomobab, And that strategy will continue as we go further up the line with the seller, second pillar is the BCMA targeted therapies, first of which is already approved, that is a BECMA, and the idea for a BECMA will to again move further up the line for eligible patients who can receive cell therapy.

And that regardless strategies 2 pronged 1.

And if he pays a single agent entering in the late line of therapy. The first day W seen with Alberta might already and then next year, we'll see the data for Cc for 80, the second sell them on which is more potent.

And then progressing them further up the line in terms of combinations you might see on Clinton trials on Gov, We've already announced.

And initiating a trial in patients who have received 2 to 3 prior lines of therapy as a combination of Alberta might but to me and my bad dexamethasone compared to Velcade.

Thanks, and medicine and.

And that strategy will continue as we go further up the line.

And with the 7 months.

The second pillar is.

And 1 b CMA targeted therapies first of which is already approved that is a beckman and the idea for our beckmann goes to again move further up the line for eligible patients who can receive cell therapies. Karma..3 is currently enrolling looking at patients who have received 3 prior lines of therapy, and then intention would be to go further up the line again for the right patient population now.

Samit Hirawat: Karma 3 is currently enrolling patients who have received three prior lines of therapy, and then the intention would be to go further up the line again for the right patient. Now, not all patients can get cell therapy because of comorbidities or other reasons. And therefore, other BCMA-directed therapies are going to be important, and that's where the T-cell engagers and the ADC come into play, but they are very early in development right now in phase one studies.

And so not all patients can get cell therapy, because of co morbidities or other reasons and therefore other bcm and directed therapies are going to be important and that's where the T cell engages and the ADC come into play, but they are very early in development right now and phase 1 studies and so more to follow on that our prioritization or our belief remains very.

Samit Hirawat: And so more to follow on that; our prioritization, our belief remains very strong that patients with multiple malema still are not cured, and we will require combination therapies in the future with multiple targets and multiple modalities will progress accordingly. Thanks so much. Catherine Guggo. Now, to our next question, please.

The beat that patients with multiple myeloma still are not cured and we will require combination therapies and the future with multiple targets and multiple modalities and will progress accordingly.

Great. Thanks, Catherine could go to our next question. Please.

Thank you, we'll now take the <unk>.

Operator: Thank you. We'll now take the next question from Tim Anderson at Wolf Research. Please go ahead.

Next question from Tim.

Anderson at Wolfe Research. Please go ahead.

Tim Anderson: Thank you. Alawquist continues to do well.

Thank you, Chris continuing to do well and of course for 1 thing that could derail it would be an appeal for ruling overturning to lower acquired can you just give us your.

Tim Anderson: Of course, the one thing that could derail the project would be an appeals court ruling overturning the lower court. Can you just give us your expectation for a timeline on an appeals court ruling? And then, just Madampton, it feels like there's a kind of a backstory on the regulatory front, you know, while you guys got the standard review because of the time of that deal you did expect and you had it in your slides, thought you'd get a second half, 2021 launch.

And your expectation for a timeline on and Appeals court ruling and.

And then.

Second.

And question.

Mavic campaign.

It feels like there's a kind of a baxter and on the regulatory front.

And I just got the standard reviewed because of the time and that deal you did expect and you had it on your slide.

And you would get a second half 2020, 1 wash so a fair amount of time has elapsed.

Tim Anderson: A fair amount of time has passed since you got the standard review, and I'm wondering if you can share, you know, what concerns the agency may have. It seems like there may be some concerns about not having long enough. Pretty bad for duration in terms of, and I think it's, So then playing with the first that you file.

Since you got the standard review and I'm wondering if you can share.

What concerns agency may have it seems like there maybe some concerns about not having long enough.

Cardiovascular duration in terms of.

Oh and advocacy.

And then playing for.

And that you filed on.

Yes.

Samit Hirawat: Yes, thanks, Tim. Sammy, do you want to start with the second question? Sure, absolutely. For Mavacampton, Tim, we've already filed with Mavacampton. The FDA has already accepted the file. We have a PDUFA date.

Team Sammy.

So I mean do you want to start with Oh, and the second question sure absolutely for Maverick camps and Tim.

And we've already filed for Maverick Hampton, the FDA has already accepted the file.

Have a purdue for date, so those concerns I think I'm relieved.

Samit Hirawat: So those concerns, I think, are relieved, and we are really looking forward to bringing these exciting data, as well as the medicine, to two patients with obstructive cartylamia. As you know, Mavampton, we have other plans that are already ongoing and in execution in other disease types as well. So we don't see it as a showstopper in any way, and we are looking forward to the readout on the regulatory side, and also bringing it globally to other parts of the world.

And we're really looking forward to bringing these exciting data as well as the medicine to patients with obstructive hypertrophic cardiomyopathy as you know with Maverick Hampton and we have other plans that are already ongoing and and execution and other disease types as well. So we don't see it as a showstopper and any any which way and.

Looking forward to really the readout on the regulatory side also bringing a globally to other parts of the world.

Samit Hirawat: Thank you, and with respect to your first question, team, on the IP litigation for eloquist. You know, first of all, as you know, we're very pleased with the decision that was made by the court last summer, which really confirms the strength of not only the compositional matter patent but also our formulation patent. And, as you mentioned, there is an appeal that has been filed, and the hearing is scheduled in September. So we look forward to hearing the result of that process. Thanks, Geoffany. Catherine, could we go to the next question, please?

Thank you for summit and with respect to your first question team on on.

The the IP litigation for illiquid.

You know first of all as you know we're very pleased with the decision on that was made by.

<unk> and by summer, which really confirms the strength of not only the composition of matter patent, but also our formulation patent and as you mentioned there is an appeal and that has been filed and the hearing is scheduled in September. So we look forward to hearing.

The result of that process.

And of course, you have on it Kathryn could we go to the next question. Please.

Giovanni Caforio: Thank you. We'll now hit the next question from Carter Gold at Barclays. Please go ahead.

Thank you.

And the next question from Carter Gould with Barclays.

Barclays. Please go ahead.

Carter Lewis Gould: Good morning, thanks and congratulations on the results so far. Maybe just first on Rebelizel, can you talk about, you know, sort of the headwinds you're still seeing from COVID and also, as you think about XUS, kind of ramping up over the second half of the year, any color and expectations or additional countries you expect to launch in?

Good morning, guys, Thanks, and congrats on the results so far.

Just first on rebels zone can you talk about some.

For the headwinds Youre still seeing from.

Thanks, Ed and also as you think about ex U S kind of ramping over the second half of the year any color on expectations for additional countries you expect to launch and and then.

Carter Lewis Gould: And then maybe coming back to Iberdamide, some of you talked about the combination study that got posted on Clinton trials.gov. Can you just talk a little bit more around just sort of demonstrating clinical meaningfulness in the setting where, you know, obviously you're going to have generic images in the not too distant future, and you're still, you know, in the study you're comparing against, there's no imit in the comparison. So just really kind of driving home that, you know, the importance of cell mods in the setting would be helpful. Thank you. Yeah, thanks.

Maybe coming back to <unk>.

Some time and you talked about the combination study that got posted on <unk> Dot Gov can you just.

Covid little bit more around.

And just sort of demonstrating.

Clinical meaningfulness, and the setting where you know obviously youre going to have.

Generic and bids and theyre, not too distant future and you're still and the <unk>.

And you're comparing against you.

Yeah, Theres no EBIT and the comparisons are just really kind of driving home that that.

And.

And the importance of cell mods and this I think would be helpful. Thank you.

Giovanni Caforio: Thanks for the questions. You know, there's really good dynamics on Repul. Let me ask Chris to give you a better perspective before we cover it at Burrdomite with Summit. Yeah, thanks for the question, Carter.

Yeah. Thanks for the questions, there's really a good dynamics on <unk>, Let me ask Chris to give you a better perspective, before we call or I've heard them and with summit. Yeah. Thanks for the question Carter, So with respect to Covid I would say, it's very similar to the answer I gave previously on Covid.

Chris Boerner: So with respect to COVID, I would say it's very similar to the answer I gave previously on COVID. I think the dynamics in that market are still evolving, and we've not yet seen a full return to normal.

Talk on the dynamics in that market are still on.

We'll evolving we've not yet seen a full return to normal, but what I would say is in the quarter. We also their salt and improvement both with respect to new patients entering the clinic and being given access to therapy as well as importantly, again, our field team's ability to.

Chris Boerner: But what I would say is in the quarter, we also saw an improvement, both with respect to new patients entering the clinic and being given access to therapy, as well as importantly, again, our field team's ability to interact with customers, and that's going to be really important here because you've got to continue to push on an urgency to treat these patients, many of whom have been treated for a considerable time on ESAs. So those dynamics, we think, are very favorable and bode well for continued growth opportunities for us as we enter the second half of the year.

But I think talked with customers and that's going to be really important here because you've got to continue to push on.

On the urgency to treat these patients many of whom have been treated for a considerable time on E. S. A's.

So those dynamics, we think are very favorable and bode well for continued on a growth.

Growth opportunities for us as we go into the second half of the year and with respect.

Chris Boerner: And with respect to the XUS launches, I say it's still very early days, but what we've seen is very good customer reception in early launch markets like Germany. The execution in those markets has been good as COVID continues to improve there, and we're able to engage with customers more. We see those dynamics continuing to improve over the course of the year.

And 2 inner ex U S launches say, it's still very early days, but what we've seen is very good customer reception and early launch markets like Germany, the execution and those markets have been good as Covid continues to improve there and we're able to engage with customers more we see those dynamics continuing to improve over the course of the year and then we have of course additional launches as access.

Chris Boerner: And then we have, of course, additional launches as access is secured, most notably with Belgium, the Netherlands, France, and Italy in the coming Thanks, and for Aberdomide, the way I look at it is there is a progression of how we move forward and how we move up the line. If you recall, over the last couple of meetings at ASCO, as well as with Ash, we've been able to show the overall profile for Iberdamide because if it's tolerated, the combineability is good, so we've been able to combine it with Dara, we've been able to combine it with Chryprolis, as well as with Valcate.

Yes, it's a secured most notably with Belgium, and Netherlands, France, and Italy, and the coming months.

Thanks, Chris and for a bit on my the way I look at it is that as a progression of how we move forward and how do we move up the line.

If you recall over the last couple of meetings and <unk> as well as ash, we've been able to show that.

The overall profile for Alberta might because of its tolerability. The combinability is good so we've been able to combine with data we've been able to come on with Kyprolis as well as with Velcade. So this is just 1 of the first studies that we have launched into phase III setting and the and the randomized trials as you know there's a phase II study that is also ongoing doing.

Chris Boerner: So this is just one of the first studies that we have launched in the Phase 3 setting in randomized trials. As you know, there's a Phase 2 study that is also ongoing doing a head-to-head comparison of Revolumet versus Iberdermide. in Europe through E&M, and we will get to see the data that will form the basis of the future phase three trial there. And there will be other studies that will be coming through where you'll start to see the comparisons versus them from it.

Our head to head competitors enough.

Revlimid versus Alberta might and Europe.

Through E and M and we will get to see that data that will form the basis of the future phase III trials, there and there will be other studies that will be coming through where you'll start to see the comparisons versus the image as well.

Samit Hirawat: Catherine, can we go to the next question? Thank you. We'll now take the next question from Louisa Hector at Barenberg. Please go ahead. Oh, thank you for taking my question. I wanted to come back and do some privacy for NED.

Thanks, so much and can we go.

And to the next question please.

Thank you.

And that takes the next question from Luisa Hector for them back.

Please go ahead.

Oh. Thank you for taking my question I wanted to come back to from credit Suisse.

Net.

Alright, and talks about hold on.

And so on the second half.

Yeah is that a delay and I know previously you've commented on your plans to build out your dermatology sales force.

Operator: Thank you. We'll now take the next question from Louisa Hector at Therenberg. Please go ahead.

Towards the end of this year is that still the plan or does that shift slightly into next year. Thank you.

Giovanni Caforio: Thanks, Louisa. Let me say we're really excited about getting ready for Dukrava. There is no delay, but I'll ask Samit to give you more perspective, and then Chris will talk about commercial preparation. Sure, thank you, Bani. And, Louisa, thanks for your question as well.

Thanks, Luisa let me.

And that's not really excited getting ready for for a new crowd out there is no delay, but I'll ask samit to give you.

For perspective, and then Chris and I'll talk about commercial preparation sure. Thank Giovanni and Louis said, Thanks for your question as well there is.

Samit Hirawat: There is one thing that we need to remember that this is an NDA, not an SNDA, and certainly two very large studies. This is a priority for the company. We are certainly looking forward to launching it in the second half of next year, and certainly, we will share the acceptance of the file as the file is validated by regulatory There is no other way to say it that we are excited about the data on efficacy and safety that we've shared. Yeah, and what I would say in terms of the commercial and medical build-out is that it's well underway.

1 thing that we need to remember that this is an NDA not and S.

And.

And certainly 2 very large studies this is a priority for the company.

And certainly looking forward to launching in the second half of next year and certainly we will share.

The acceptance of the file as the file is validated by the regulatory agencies that has no other.

Way to say it that we're excited about the data with the.

Efficacy and the safety that we've shared before.

And what I would say in terms of the commercial and medical Buildout is thats well underway, we feel very good about where we are and the quality of the teams that we've been able to put in place medical has been in place for a number of months and I would say those teams have very deep dermatology experience. We obviously have our key internal.

Samit Hirawat: We feel very good about where we are and the quality of the teams that we've been able to put in place. Medical has been in place for a number of months, and I would say those teams have very deep dermatology experience. We obviously have our key internal roles that have been filled in the process of building out launch planning. Our plan is, and has been, to build out the sales teams in the second half of this year.

N D and roles that had been filled and are in the process of building out launch planning. Our plan is and has been to build out the sales teams and the second half of this year, we feel very good about where we are and that timing and.

Samit Hirawat: We feel very good about where we are in that timing, and our anticipation is that we're going to be ready for launch whenever the approval comes. And so really, no change in how we're thinking about building out the commercial. Thanks, Catherine. Could we go to the next question, please?

And our anticipation is that we're going to be ready for launch whenever the approval comes and so really no change and how we're thinking about building out the commercial teams.

Internally Thanks, Catherine could we go to the next question. Please.

Operator: Thank you. We'll now take the next question from Steve Scala at Cohen. Please go ahead.

Thank you and we'll now take the next question from Steve Scala at Cowen. Please go ahead.

Steve Scala: Thank you. I have a few questions. Regarding Factor 11, a BTE, total knee replacement phase two data summit, you said that the trial showed exactly what you expected.

Thank you I have a few questions regarding the factor 11, a DTE total knee replacement phase III data summit, you said that the trial showed exactly what.

And was expected can you remind us of what you expected for instance did you expect zero bleeds.

Steve Scala: Was expected? Can you remind us of what you expected? For instance, did you expect zero bleeds?

Steve Scala: Second, has the FDA asked any questions on drugavitinib CV risk, and if so, what was the nature of those questions? And then lastly, do you expect an FDA panel for Mavacampton? Thank you.

Second has the FDA asked any questions on Duke of Us sit nib CV risk and if so what was the nature of those questions and then lastly, do you expect and FDA panel for Maverick Campton. Thank you.

Thank you, Steve let me ask.

Samit Hirawat: Let me call a summit to address all three of your questions. So for Factor 11A, Steve, what I say we got what we wanted was a multi-armed study where we looked at single daily doses as well as BID, and it was a dose range. What we wanted from the study was to give us an inkling on, number one, the safety profile that we were observing, as well as to see what the dose that we should take to phase three.

And summit to address all 3 of your Oh for your questions and so for factor 11 day Steve.

And I'd say, we got what we wanted is it was a multi arm study, where we looked at single daily doses, whether it would be and it was a dose range.

We wanted from the study to give us an inkling on number 1 the safety profile that we were observing as well is to see what is the dose that we should take to phase III and that's what we intended from the study and Thats, what we got and plus we wanted to see the therapeutic index overall.

Samit Hirawat: And that's what we intended from the study, and that's what we got. And plus, we wanted to see the therapeutic index overall, what that range one can use in future programs, and that's what we got. Now, of course, you'll hear more as the data are presented later this year, but this is where we started off in the TKR study, and that's what we did. On the Ducravast study, which you asked about the cardiovascular risk questions, et cetera, from the regulatory agencies, of course, we will not comment on our conversations with the regulatory agencies.

And what those range, 1 can use and the future programs and that's what we got now of course, you'll hear more as the data are presented later this year, but this is where we started off in the TCR study and Thats, what we got.

On the <unk> study.

And that you asked about what the what the cardiovascular risk questions et cetera from the regulatory agencies.

<unk> of course, we will not comment on our conversations.

With the regulatory agencies, having said that you've seen the data we've shown what the non existence of cardiovascular risk and the follow up that we have for Duke relative to NIM and we are very pleased with the profile that we currently have which is very differentiated.

Samit Hirawat: Having said that, you've seen the data, you've shown that there is no cardiovascular risk in the follow-up that we have for Dukravacetanib, and we are very pleased with the profile that we currently have, which is very different. On the Mavakampton side, once again, not commenting on the regulatory strategies and regulatory conversations, but we continue to look forward to the Perdufa date in January, and we are certainly very excited with the data on that side of the time. Thank you. Catherine, could we go to the next question, please?

And on the Maverick Hampton side, once again, not commenting on the regulatory strategies and regulatory conversations, but we continue to look forward to the Purdue for date in January and we are certainly very excited with the data on that side as well.

Thanks Summit and Katherine and can we go to the next question. Please.

Operator: Thank you. We'll now take the next question from Matthew Harrison at Morgan Stanley. Please go ahead.

Thank you we will now take.

For the next question from Matthew Harrison of Morgan Stanley. Please go ahead.

Matthew Harrison: Great, good morning, thanks for taking the questions. I guess two for me, following up on a couple questions from before.

Great. Good morning, Thanks for taking the question I guess 2 for me following up on a couple of questions from before on on factor 11 can you just maybe put the secondary stroke trial into context, what what is a good outcome from that study and.

Matthew Harrison: On Factor 11, can you just maybe put the secondary stroke trial into context? What would be a good outcome from that study when we see the results later this year? And then second, on the cell mods, especially now that you have some data in-house, what do you see as the quickest sort of regulatory plan to get that to market? Thanks.

And when we see the results later this year and then and second.

And on on on the cell mods, especially now that you have some data in house.

What do you see as the as the quickest sort of regulatory plan to get to get that to market. Thanks.

Samit Hirawat: Thanks. Let me ask Samet to address both of your questions. For Factor 11A in secondary stroke prevention, the aim of the trial is to be able to see if Factor 11A can be combined with the background therapy of anti-platalysis. And that's what we are looking forward to because, as you recall, Factor 10A inhibitors that are out there have a higher risk of bleeding when they are combined with anti-platelet blood So that's what a good outcome would look like if we can actually manage that risk profile that is there, and that will then pave the way for taking it forward into indications that are to be discussed with our partners and, of course, with the agency.

Thanks for that to let me ask summit to address.

And I spoke of your questions and thank you for.

For factor 11 name from the secondary stroke prevention. The aim of the trial is to be able to see if factor 11, 8 can be combined with the background therapy of anti platelet agents and that's what we're looking forward to it because as you recall factor 10, a inhibitors that are out there.

And have a higher risk of bleeding when theyre combined with anti plated therapies. So that's what the good outcome would look like if we can actually manage that risk profile that is there and that will then paved the way for taking it forward into indications that ought to be discussed with our partners and of course for the agencies and the future for.

Samit Hirawat: For Selmots, as Giovanni already shared in his prepared remarks, we've seen the data from the phase two trial of Iberdamide. We are looking forward to having those conversations with the health agencies based on the overall response rate data and the overall profile that we have for abertomide. And then that will pave the way for seeing if we can bring the drug to market with these data or not. And we'll share those as we know more.

Our cell mods as Joe.

I've already shared with you in his prepared remarks, we've seen the data from the phase 2 trial of a berta might.

Looking forward to having those conversations with the with the health agencies based on the overall response rate data and the overall profile that we have for Alberta might and then that will pave the way for seeing if we can bring the drugs.

And to market with these data or not and we'll share those as a as we know more.

Samit Hirawat: Let me just say that with cell modes, you know, we have been discussing the progress with this platform for some time, and I think it's really good to be seeing now that we have four, five agents in the clinic, and the Iberdomite data is really the beginning of looking at really important proof of concept data on a number of assets, and I'm really pleased that this platform is progressing. Well, I think it's going to be really important for us going forward. Catherine, Catherine, please.

Let me just say that with the with 7 months, we have been discussing the progress with this platform.

For some time and I think it's really good to be seeing now that we have for 5 of those agents and.

Giovanni.

And the advert on my data is really the beginning.

<unk> looking at really important proof of concept data on a number of assets and I'm really pleased with that.

On this platform is progressing so well I think it's going to be really important for us going forward.

Thanks, Giovanni and Katherine can we go to our next question. Please.

Thank you we'll take the next question for Matt.

Giovanni Caforio: Thank you. We'll take the next question from Matt Sips at William Blair. Please go ahead.

William Blair. Please go ahead.

Operator: Good morning, sir. I'm taking my question.

Alright, and thanks for taking my question. Another factor today, 10, or 11 and a question do you have any thoughts on the recent antibody.

Matthew Christopher Phipps: Another factor 10A or 11A question.

Matthew Christopher Phipps: 11A question. Do you have any thoughts on the recent antibody results in total knee orthoplastia that were published in the Journal of Medicine last week? Obviously, they saw a nice VT prevention, but no real difference in bleeding rates, which might be expected given that it was a smaller-sized study. And then, I guess, just any general thoughts on an antibody versus small molecule approach. And then lastly, can you just confirm if any additional clinical studies for Dukra, whether it be longer follow-up or any healthy participant data with BDI or anything is needed prior to Thank you, Samet. Let me start on Factor 11A. I will...

<unk> and total knee.

The buses that were published in New England Journal and Medicine last week, obviously, some nice VP prevention, but no real difference and bleeding rates, which might be expected given that was a smaller sized study and then I guess, just and or any general thoughts on and antibody for a small molecule approach.

And then lastly can you just confirm it any additional clinical studies.

As for <unk>, whether it be longer follow up or a healthy participant data with DDI or anything as needed prior to submission.

Thank you summit, let me start on the factor 11 day I will [laughter].

Samit Hirawat: I will refrain from commenting on anybody else's studies, but certainly there is the specificity of the antibodies that we have to keep in mind. On the other hand, then you have to keep in mind the oral versus IV aspect of things and oral versus subcutaneous, which will be very important in future development and the patient burden as well as the health care system. So we'll need to continue to monitor that, and then we'll compare the results when full results are available for our program and then other programs as well, taking into account the progress of Phase 3.

And I hold myself from commenting on anybody else's studies, but certainly there there's the specificity.

And the antibodies that we have to keep in mind on the other hand, and you have to keep in mind, the oral versus IV aspect of things and auto versus subcutaneous, which will be very important and the future development and the patient burden as well as the health care system. So we will need to <unk>.

Continue to monitor that and then we'll compare the results and full results out of way.

<unk> for our program and other programs as well as we take into account phase III development for Duke of assets and if as we have previously talked about we are looking forward to the approval in the second half of next year. So we're not waiting for additional studies from that perspective unless of course.

Samit Hirawat: For Duke of As we have previously talked about, we are looking forward to approval in the second half of next year, so we are not waiting for additional studies from that perspective unless, of course, they become a part of the conversations with the health

<unk> become a part of the conversations with the health agencies.

Samit Hirawat: I think we've maybe got time for one last question. Thank you. We'll now take the next question from Dane Leon at Raymond James. Please go ahead.

And I think we've got time for 1 last question.

Thank you we will now take the next question from Dane Leone Raymond James. Please go ahead.

Operator: Hi, thank you very much for taking the questions and getting one last one in here for me, and I appreciate the updates across the portfolio. Just one quick one to wrap things up on Factor 11A.

Alright, Thank you very much for taking the questions and.

That'd be 1 last 1 here for me.

And I appreciate.

The updates across the portfolio just 1 quick 1 to wrap things up on factor 11 and a.

Dane Leone: How do you see the program evolving? Obviously, you seem to sound encouraged by the results you have in house that will be presented later on TKR. But are you going to take additional compounds into the clinic? You recently published a paper on 724-296 that looked promising.

How do you see that program evolving obviously, you've seen it sound encouraged by the results you have in house that will be presented later on TK.

Our.

But are you going to take additional compounds into the clinic you recently published a paper on 7 in Q4.296 that look promising.

Samit Hirawat: Just thinking about your competitors and the multi-prong approach they're taking versus how you see the program expanding over time. Thank you. Thank you for the question. For Factor 11A, we are pleased with the profile that we have thus far for Factor 11A that is in the clinic already, the Milvixian molecule. We do have a backup, but that is progressing at its own pace. We are not accelerating that.

Thinking about your competitors and the multi pronged approach, they're taking versus how you see that program expanding over time. Thank you.

Good day. Thank you for the question for factor 11 day, we are pleased with the profile that we have thus far for factor 11 day that is in the clinic already the mill Vixen and a molecule. We do have a backup but that is progressing as 1 would always have a backup plan and its on pace, we're not accelerating that.

Samit Hirawat: We are looking forward to seeing the data for the secondary stroke prevention study early next year, and that would then pave the way for the Phase 3 program. There is nothing more to add. Thank you, and thank you all for joining us today. As we've discussed throughout the call, we had a very successful quarter. We delivered strong results consistent with our strategy by continuing to grow revenue, execute on new launches, and advance our pipeline.

We're looking forward to seeing the data for the secondary.

For stroke Prevention study early next year and that would then pave the way for a phase III program.

And nothing more to add from that perspective at this time.

Thank you Simon and thank you all for joining us today as we've discussed throughout the call and we had a very successful quarter, we delivered strong results consistent with.

Our strategy by continuing to grow revenue execute on new launches and advance our pipeline I'm proud of what our team has accomplished so far this year, including the attainment of several important milestones and I'm really encouraged by what we are doing for patients I believe and we're very well positioned for the future I'd like to thank.

Samit Hirawat: I'm proud of what our team has accomplished so far this year, including the attainment of several important milestones. And I'm really encouraged by what we are doing for patients. I believe we are very well positioned for the future. I'd like to thank everybody for participating in the call, and of course, our team is available to answer any additional questions you may have. Thank you, and have a good day.

And they use Friday for participating in the call and of course, our team is available to answer any additional questions. You may on thank you and have a good day.

Operator: That concludes the day's call. Thank you for your participation. You may now disconnect.

That concludes today's call. Thank you for your participation you may now disconnect.