Q3 2021 Bristol-Myers Squibb Co Earnings Call

Yeah.

Good day and welcome to the Bristol Myers Squibb, 2021 third quarter results conference call.

Tim Power: Good day, and welcome to the Bristol-Myers Squibb 2021 third quarter results conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

Today's conference is being recorded at this time I would like to turn the conference over to Mr. Tim Power Vice President Investor Relations. Please go ahead Sir.

Thanks, Christina and good morning, everyone. Thanks for joining us for our third quarter 2021 earnings call.

Tim Power: Christina. Good morning, everyone. Thanks for joining us for our third quarter 2021 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also with me for today's call are Chris Boerner, our Chief Commercialization Officer, and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Deployment. You'll note that we've posted slides to bms.com, and you can use those to follow along with Dave and Giovanni's remarks.

Joining me this morning with prepared remarks are Giovanni for you or board Chair and Chief Executive Officer, and David Elkins, Our Chief Financial Officer.

Also with me for today's call are Chris Boerner, our Chief commercialization officer someone here, what our Chief Medical Officer, and head of global drug development.

You'll note that we've posted slides to BMS dot com and you can use those to follow along with David and Giovanni's remarks, but before we get started I'll read our forward looking statements during.

Tim Power: But before we get started, I'll read our forward-looking statement. 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 in the company's SEC filing. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date.

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 in the company's SEC filings. These forward looking statements represent our estimates as of today and should not should not be relied upon as representing.

Our estimates as of any future date, we specifically specifically disclaim any obligation to update forward looking statements, even if our estimates change.

Tim Power: Specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of these non-gap financial measures to the most comparable gap measures are available at bms.ca, But I'll hand it over to Giovanni. Thank you, Tim. And good morning, everyone.

We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at BNS Dot com.

And with that I'll hand, it over to Giovanni.

Thank you Tim and good morning, everyone I hope, you're all doing well.

Giovanni Caforio: I hope that you're all doing well. Now turning to slide four, I'm pleased to report a very good third quarter with solid sales growth driven by strong commercial execution and good progress in our pipeline. I'm proud of the performance of our commercial teams who dropped demand growth for our launch products and delivered solid performance for our in-line products, including Revlimid, Opdivo, and Electric. In R&D, we are progressing the most promising assets in our pipeline for sustained growth. In the quarter, we advanced our third I.O. mechanism with the fixed dose of Relatlimab plus Nivo accepted for priority review in the U.S. for the treatment of patients with unresectable or metastatic melanoma.

Now turning to slide four I'm pleased to report a very good third quarter with solid sales growth driven by strong commercial execution and good progress in our pipeline.

I'm proud of the performance of our commercial teams, who dropped demand growth for our launch products and delivered solid performance of our in line products, including Revlimid Opdivo and eloquence.

In R&D, we are progressing the most promising assets in our pipeline for sustained growth in the quarter, we advanced our third Io mechanism with the fixed dose over a lifetime plus knievel accepted for priority review in the U S for the treatment of patients with unresectable or metastatic melanoma.

He is an important development for the Io franchise, and we have additional data readouts for Opdivo on the horizon.

Giovanni Caforio: This is an important development for the I.O. franchise, and we have additional data readouts for D.I.V.O. on the horizon.

From a financial perspective, we reported sales of $11 6 billion and non-GAAP EPS of $2 with growth of 10% and 23% respectively.

Giovanni Caforio: From a financial perspective, we reported sales of $11.6 billion and non-GAAP EPS of $2, with growth of 10% and 23%, respectively. I am encouraged by our results and how they position us for the rest of 2021 and for the future. As a result, we are reaffirming our revenue guidance and raising the lower end of our non-GAAP EPS guidance. Our balance sheet is strong, and we continue to pursue a disciplined capital allocation, focused on investing in internal and external innovation.

Encouraged by our results and how they position us for the rest of 'twenty, one and for the future.

As a result, we are reaffirming our revenue guidance and raising the lower end of our non-GAAP EPS guidance range.

Our balance sheet is strong and we continue to pursue a disciplined capital allocation strategy focused on investing in internal and external innovation opportunities.

On the IP front, we are pleased with the decision by the U S Court of Appeals for the Federal Circuit Federal circuit, upholding the eloquence, IP and providing exclusivity until 2028 under existing settlements.

Giovanni Caforio: On the IP front, we are pleased with the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis IP and providing exclusivity until 2028 under existing law. This decision confirms our belief in the value of the science behind Eliquis and the underlying IP protecting its innovation.

Seasonal confirms our belief in the value of the science behind <unk> and the underlying IP protecting its innovation.

Overall I'm extremely pleased with our progress in the water.

Giovanni Caforio: Overall, I'm extremely pleased with our progress. Turning to our execution scorecard on slide 5. At the start of the year, I laid out this scorecard with the milestones we thought would be important for us to deliver in order to successfully renew our. The team has worked hard, and I'm proud that we're making progress across. A number of accomplishments were included on the prior slide, so I won't go through all the details.

Turning to our execution scorecard on slide five.

At the start of the year I laid out. This this scorecard with the milestones we thought would be important for us to deliver in order to successfully renew our portfolio.

The team has worked hard and I'm proud that we're making progress across the board.

A number of accomplishments were included on the prior slide So I won't go through all the details, but I want to call out a few highlights here David will provide more details in his remarks.

Giovanni Caforio: But I want to call out a few highlights here. David will provide more details in his report. I'll start with the crevices.

I'll start with Cabozantinib do crop has demonstrated a compelling and differentiated profile in two phase III studies as the oral treatment of choice in psoriasis and is an important asset with significant potential across a number of indications, including psoriasis arthritis, where we have already initiated a phase III pro.

Giovanni Caforio: Krava has demonstrated a compelling and differentiated profile in two phase 3 studies as the oral treatment of choice in Sorana, and is an important asset with significant potential across a number of indications, including Psoriatic Arthritis, where we have already initiated a phase 2. Although we did not achieve proof-of-concept in a Phase II study for ulcerative colitis, we are committed to advancing our promising Ducravacidin A clinical program in inflammatory bowel disease, including another study for ulcerative colitis, as well as Crohn's disease. Lupus, and other immune-mediated diseases.

Graham.

Although we did not achieve proof of concept in a phase II study for ulcerative colitis, we are committed to advancing our promising to cover Sydney clinical program in inflammatory bowel disease, including another study for ulcerative colitis, as well as crohn's disease, and lupus and other immune mediated diseases.

We continue to make great progress in our cell therapy franchise, and we look forward to presenting the transformed data for <unk> in second line <unk> at Ash, we're excited with the strength of these data, which have the potential to enable our cell therapy franchise to reach a broader set of patients and.

Giovanni Caforio: We continue to make great progress in our cell therapy franchise, and we look forward to presenting the transformed data for Brianzi in second line DLBCL at ASH. We're excited with the strength of this data, which has the potential to enable our cell therapy franchise to reach a broader set of patients. And we are also looking forward to presenting data from the first phase two study for Melvexian for VTE prevention in patients undergoing total knee replacement at the American Heart Association Conference in a few Looking at the overall strength of execution so far, I am confident that we are on track to deliver what is required for us to renew our. Moving to slide 6. It has been two years since we formed the new Bristol-Myers Squibb.

And we are also looking forward to presenting data from the first phase III study for mill vaccine for <unk> prevention in patients undergoing total knee replacement at the American Heart Association Conference a few weeks.

Looking at the overall strength of execution, so far I am confident that we are on track to deliver what is required for us to renew our portfolio.

Moving to slide six it has been two years since we formed the new Bristol Myers Squibb.

Reflect on this time, we have already made great progress we are doing what we set out to do delivering on the value drivers of the integration and most importantly, establishing a strong foundation for our company's growth well into the future.

Giovanni Caforio: As I reflect on this time, we have already made great progress. We are doing what we set out to do, delivering on the value drivers of the integration, and, most importantly, establishing a strong foundation for our company's growth well into the future. Knowing that we face losses of exclusivity in the coming years, I recognize that executing well on our multiple launches and continuing to advance our pipeline is particularly important for. When I reflect on the last two years, I'm pleased on both fronts.

Knowing that we face losses of exclusivity in the coming years, I recognize executing well on our multiple launches and continuing to advance our pipeline is particularly important for us when I reflect on the last two years I'm pleased on both fronts we.

We see strong demand for our newly launched products and we are delivering on the promise of our pipeline, including a broadening dataset for our launch products and continuing progress with our next generation of assets such as mill vaccine anti bird denied our company today is more diversified than ever before with <unk>.

Giovanni Caforio: We see strong demand for our newly launched products, and we are delivering on the promise of our pipeline, including a broadening data set for our launch products and continuing progress with our next generation of assets, such as Milvexian and Iberdo. Our company today is more diversified than ever before, with four durable franchises and the financial flexibility to continue to invest in innovation. As we recently announced, we will be hosting an investor event on November 16 in New York City to review our progress over the last two years and further discuss the company's strategy, pipeline, and business opportunities. I look forward to the meeting, and I hope you will join us.

For durable franchises and the financial flexibility to continue to invest in innovation.

We recently announced we will be hosting an investor event on November 16 in New York City to review our progress over the last two years and further discuss the company's strategy pipeline and business opportunities.

Look forward to the meeting and I Hope you will join US in closing we have made significant progress through this period and I would like to thank our global teams, who have maintained the focus on delivering for patients with that I'll turn it over to David to walk you through the financials David.

Giovanni Caforio: In closing, we have made significant progress through this period, and I would like to thank our global teams who have maintained the focus on delivering for patients. With that, I'll turn it over to David to walk you through the financials.

Thank you Giovanni and thank you all for joining our call today, starting with our top line performance on slide eight we had yet another strong quarter with third quarter revenues growing double digits versus prior year, primarily due to demand increased demand for our in line brands, but as well as our new product portfolio. So.

David V. Elkins: Thank you, Giovanni. And thank you all for joining our call today. Starting with our top line performance on slide eight, we had yet another strong quarter, with third quarter revenues growing double digits versus the prior year, primarily due to demand, increased demand for inline brands, but also due to our new product portfolio. So let me shed some light on some of our product performance, starting with Eloquist on slide nine. Eloquist continues to perform very strongly, with global sales up 15% versus the prior year.

So let me shed some light on some of our product performance starting with the eloquence of on slide nine.

<unk> continues to perform very strong with global sales up 15% versus prior year in U S. Sales grew 18% versus prior year demand growth continues to be strong with total prescription growth of 14% versus last year, driven by Iraq, Cogs market share gains and growth in new to brand volumes.

David V. Elkins: In the U.S., sales grew 18% versus the prior year. Demand growth continues to be strong, with total prescription growth of 14% versus last year, driven by OAC class market share gains and growth in new-to-brand volume. As usual, sales were impacted by the expected coverage gap liability that occurs in the 3rd and 4th quarters each year.

Sequentially as usual sales were impacted by the expected coverage gap liability that occurs in the third and fourth quarters. Each year, we expect strong new to brand share growth to further translate to overall total prescription growth.

David V. Elkins: We expect strong new-to-brand share growth to further translate to overall total prescription growth. Internationally, sales grew 12% versus the prior year primarily due to demand. Shares continue to increase across all key geographies and continue to rank as the number one OAC in multiple markets with additional room to grow. We remain really pleased with Eloquist's execution around the world and expect to continue to grow its share within a growing class. Now moving to Updiva's performance on slide 10, we are pleased with the continued momentum for the brand with sales growth of 7% versus the prior year.

Nationally sales grew 12% versus prior year, primarily due to demand shares continue to increase across all key geographies and continues to rank as the number one <unk> in multiple markets with additional room to grow.

We remain really pleased with eloquence is execution around the world and I expect to continue to grow eloquent share within a growing class.

Now moving to Opdivo performance on Slide 10, we are pleased with the continued momentum for the brand with sales growth of 7% versus prior year.

In the U S sales grew 4% versus last year, primarily driven by uptake in first line lung cancer and our multiple other new launches this year and sequentially, we had demand growth of 5%, which was offset by work down of $40 million in inventory build we noted in the second quarter, our commercial teams continue to execute well with.

David V. Elkins: In the U.S., sales grew 4% versus last year, primarily driven by uptake in first-line lung cancer and our multiple other new launches this year. And sequentially, we had demand growth of 5%, which was all set by working down a $40 million inventory build we noted in the second quarter.

David V. Elkins: Our commercial teams continue to execute well, we've retained strong positions in core indications such as melanoma and renal, and we are very pleased with the performance of our newer indications. Outside the U.S., we had another strong quarter with sales up 11% versus last year. Growth was primarily driven by demand for new indications and expanded access in Latin America, Turkey, and Russia.

Retained strong positions in core indications such as melanoma and renal and are very pleased with the performance of our newer indications outs.

Outside the U S. We had another strong quarter with sales up 11% versus last year growth was primarily driven by demand for new indications and expanded access in Latin America, Turkey, and Russia, we continue to see strong uptake from our new launches in lung and renal cancer in Germany, and Japan with pricing and reimbursement discussions ongoing in other key.

David V. Elkins: We continue to see strong results from our new launches in lung and renal cancer in Germany and Japan, with pricing and reimbursement discussions ongoing in other key markets. These launches, together with recent approvals of first-line gastric and adjuvant esophageal cancer, are expected to contribute to further growth internationally. Based on positive momentum from our current launches and future potential launches, including first-line esophageal in May of next year, as well as expansion opportunities from clinical trials that we'll read out over the next few years, the promise for Abdiva's continued growth is high.

Markets.

These launches together with recent approvals of first line gastric nitrogen suffered geo cancer are expected to contribute to further growth internationally.

Based on positive momentum from our current launches and future potential launches, including first line of Suffolk deal in May of next year as well as expansion opportunities from clinical trials that will read out over the next few years the promise for Opdivo continued growth is high.

Turning to our in line multiple myeloma portfolio on slide 11, Revlimid was up 11% globally, primarily driven by demand for triple based therapies and increasing treatment duration Pamela its global sales were up 10% driven by continued demand for triple based therapies and use in earlier lines.

David V. Elkins: Turning to our inline multiple myeloma portfolio on slide 11, Revlimid was up 11% globally, primarily driven by demand for triplet-based therapies and increasing treatment duration. Pomelos global sales were up 10%, driven by continued demand for triplet-based therapies and use in earlier lines.

Now moving to our new products on slide 12, we continue to be very pleased with our new products, which generate sales of $344 million in the third quarter. This new diversified portfolio was already annualized and close to one 5 billion run rate, giving us great confidence that we're on our way to renewing our business with products that are much earlier in their <unk>.

David V. Elkins: Now, moving to our new products on slide 12, we continue to be very pleased with our new products, which generated sales of $344 million in the third quarter. This new diversified portfolio is already annualizing close to $1.5 billion run rate, giving us great confidence that we are on our way to renewing our business with products that are much earlier in our lifecycle. So let's start with Rebocell, which generated strong sales of $160 million in the third quarter, up 67% versus the prior year.

Cycle.

So, let's start with Red blood cell, which generated strong sales of $160 million in the third quarter up 67% versus prior year.

Sales growth in the U S was primarily driven by continued demand and the Esa refractory Mds patients as well as a 20% to $25 million of inventory build we are very encouraged by the recent NCC and guideline update that now recommends evaluating Esa response sooner at six to eight weeks instead of the previously.

David V. Elkins: Sales growth in the U.S. was primarily driven by continued demand in ESA refractory MDS patients, as well as a $20 to $25 million inventory build. We are very encouraged by the recent NCCN guideline update that now recommends evaluating ESA response sooner, at 6-8 weeks instead of the previously recommended 12-16 weeks.

Commended 12 to 16 weeks this supports need to monitor and potentially treat new patients earlier in their treatment journey. Additionally, we remain focused on ensuring they receive the most appropriate dose for sustained benefit.

David V. Elkins: This supports the need to monitor and potentially treat new patients earlier in their treatment journey. Additionally, we remain focused on ensuring they receive the most appropriate dose for sustained benefit. Outside the U.S., uptake continues to be strong in countries where Robloxel is launched, although sales were impacted by the usual price review one year after launch in Germany. We expect to launch in Italy and the Netherlands in Q4 pending reimbursement discussions, and in more countries in 2022 to drive additional growth for the brand. Moving on to our cell therapies Becma and Brionzi.

Outside the U S uptake continues to be strong in countries, where <unk> launched.

Sales were impacted by the usual price review of one year after launch in Germany.

We expect to launch in Italy, and the Netherlands in Q4 pending reimbursement discussions and in more countries in 2022 to drive additional growth for the brand.

Moving to our cell therapies at Beckman <unk> demand for <unk>, our first in class B CMA car T remains robust, we generate $71 million in the third quarter versus $24 million in the second quarter.

Remember that two two revenues consisted of only one five months of sales having launched in mid May. So performance. This quarter reflects a full quarter of sales demand.

David V. Elkins: Demand for Becma, our first in class BCMA CAR T remains robust. We generated $71 million in the third quarter versus $24 million in the second quarter. Remember that 2Q revenues consisted of only 1.5 months of sales, having launched in mid-May, so performance this quarter reflects a full quarter of sales. Demand continues to exceed supply, and we expect Q4 revenues to be largely similar to Q3. Now moving to our CD19 CAR-T Brianzi, sales in the quarter were $30 million versus $17 million in the prior quarter.

Demand continues to exceed supply and we expect Q4 revenues to be largely similar to Q3.

Now moving to our CD 19 car T. Brianti sales in the quarter were $30 million versus $17 million in the prior quarter sales increased due to patient demand with physicians recognize embryonic. These best in class profile. We're extremely pleased to have clinically meaningful <unk> data in second line large b cell lymphoma, and look forward to presenting the day.

At Ash and bringing this treatment earlier line patients in 2022.

Turning to suppose Ya global revenues were $40 million in the quarter driven by multiple sclerosis launch and onetime inventory build in the U S. The.

David V. Elkins: Sales increased due to patient demand, with physicians recognizing Brionzi's best-in-class profile. We're extremely pleased to have clinically meaningful EFS data in second-line large B-cell lymphoma and look forward to presenting the data at ASH and bringing this treatment to earlier-line patients in 2022. Turning to Symposia, global revenues were $40 million, and a quarter driven by the multiple sclerosis launch and one-time inventory build in the U.S. The MS launch continues to progress well, where Suposio remains the S1P of choice in terms of written prescriptions.

The <unk> launch continues to progress well, we're supposedly remains the <unk> of choice in terms of written prescriptions. We continue to focus on establishing symposia as not only the S. One P of choice, but also the oral treatment of choice in MFS.

Our launch in UC is also progressing well in the U S. We are encouraged by the initial uptake in growth in the number of new trial is since launch in June our focus is building on volume establishing demand for this oral biologic like medicine broadening access over time.

We're also very pleased to have just received see HMP positive opinion in Europe, and look forward to making <unk> available to patients living with UC as soon as possible.

David V. Elkins: We continue to focus on establishing sepposia as not only the S1P of choice but also the oral treatment of choice in MS. Our launch in UC is also progressing well in the U.S. We are encouraged by the initial uptake and growth in the number of new trialists since its launch in June.

Lastly, we're making progress on establishing an erratic in first line maintenance in AML patients on <unk> generated sales of $21 million in the quarter, primarily driven by increased demand as well as inventory build versus prior quarter.

David V. Elkins: Our focus is building on volume, establishing demand for this oral, biologic-like medicine while broadening access over time. We are also very pleased to have just received CHMP's positive opinion in Europe and look forward to making Symposia available to patients living with UC as soon as possible. Lastly, we're making progress on establishing Onirag and first-line maintenance in AML patients. Onirake generated sales of $21 million in the quarter, primarily driven by increased demand as well as inventory build versus the prior quarter.

We continue to focus on shaping the new maintenance segment, and increasing adoption and patient adherence.

Now, let's turn our attention over to P&L on slide 13, we've already covered our strong sales for the quarter. So let me walk you through a few other non-GAAP key line items.

Gross margin increased versus prior year, primarily due to lower royalty payments operating expenses were higher than last year, particularly in R&D due to COVID-19 recovery, but also slightly in MSA due to investment supporting our launch and prelaunch activities.

MSA versus prior quarter did experience some softness due to timing of investments that have shifted to the fourth quarter.

David V. Elkins: We continue to focus on shaping the new maintenance segment and increasing adoption and patient adherence. Now, let's turn our attention over to P&L on slide 13. We've already covered our strong sales for the quarter, so let me walk you through a few other non-gap key line items. Gross margin increased versus prior year primarily due to lower royalty payments. Operating expenses were higher than last year, particularly in R&D due to COVID recovery, but also slightly in MS&A due to investments supporting our launch and pre-launch activities. MS&A versus the prior quarter did experience some softness due to timing of investments that have shifted to the fourth quarter. Our effective tax rate of 14.9% was primarily driven by earnings.

Our effective tax rate of 14, 9% was primarily driven by earnings mix overall, non-GAAP EPS increased 23% year over year.

Now moving to our balance sheet and capital allocation on slide 14, our liquidity position remained strong with almost $16 billion in cash and marketable securities and our strong cash flow from operations of $5 3 billion in the quarter.

Our capital allocation priorities remain unchanged with significant financial flexibility to support a balanced approach to capital allocation. Our priorities are to continue to renew and diversify our portfolio through business development paying down our debt and returning capital to shareholders. We've executed several business development deals this year, bringing in differentiation.

David V. Elkins: Overall, non-GAAP EPS increased 23% year-over-year. Now moving to our balance sheet and capital allocation on slide 14, our liquidity position remains strong with almost $16 billion in cash and marketable securities and a strong cash flow from operations of $5.3 billion in the quarter. Our capital allocation priorities remain unchanged. We have significant financial flexibility to support a balanced approach to capital allocation. Our priorities are to continue to renew and diversify our portfolio through business development, paying down our debt, and returning capital to shareholders.

<unk> early stage assets.

This development remains a top priority as a leading innovation based company.

We have paid down 6 billion in debt year to date and are committed to maintaining our strong investment grade rating.

As it relates to returning capital to shareholders, we're committed to growing our dividend subject to board approval and remain opportunistic about share repurchases. We have already purchased $3 5 billion of shares to date and we currently have approximately $3 billion remaining in our authorization program.

Now turning to our guidance on slide 15 based on our strong performance in the quarter, we are reaffirming full year sales and raising the lower end of our non-GAAP EPS guidance. We continue to expect revenues to increase at the higher end of our guidance and gross margin to be approximately 80%.

David V. Elkins: We've executed several business development deals this year, bringing in differentiated early stage assets. Business development remains a top priority as a leading innovation-based company. We have paid down $6 billion in debt year-to-date and are committed to maintaining our strong investment-grade rating.

Moving to operating expenses, we are maintaining our <unk> and R&D guidance for the year as I mentioned earlier <unk>, we're expecting higher expenses in the fourth quarter due to timing of investments that shifted by a quarter.

Additionally, we're updating our tax rate guidance to approximately 16, 5% primarily due to earnings mix.

David V. Elkins: As it relates to returning capital to shareholders, we're committed to growing our dividends subject to board approval and remain opportunistic about share repurchase. We have already purchased $3.5 billion of shares to date, and we currently have approximately $3 billion remaining in our authorization program. Now turning to our guidance on slide 15, based on the strong performance in the quarter, we're reaffirming full year sales and raising the lower end of our non-GAAP CPS guidance.

Oh, no what I'm pleased with our performance we had another remarkable quarter for the company and continue to execute well against our plans and to diversify and renew our portfolio.

Performance can not been achieved without the passion and dedication of our employees around the world and I look forward to providing you future updates on our progress with that I'll now turn it back over to Tim and Giovanni for Q&A.

Great. Thanks, David Christina can we go to our first question. Please.

Yes. Thank you again, if you would like to ask a question. Please press star one again Thats Star one quick question.

David V. Elkins: We continue to expect revenues to increase at the higher end of our guidance and gross margin to be approximately 80%. Moving to operating expenses, we are maintaining our MS&A and R&D guidance for the year. As I mentioned earlier, for MS&A, we are expecting higher expenses in the fourth quarter due to timing investments that shifted by a quarter.

Yeah.

We will take our first question from Geoff Meacham with Bank of America.

Hey, guys. Thanks for taking the question and congrats on a good quarter I just wanted to ask on the new launches the beckmann launch.

It was pretty good just give us a sense for how much of that is still a bolus of patients versus underlying demand and this.

David V. Elkins: Additionally, we're updating our tax rate guidance to approximately 16.5%, primarily due to earnings. All in all, I'm pleased with our performance. We had another remarkable quarter for the company and continue to execute well against our plans and to diversify and renew our portfolio. This performance cannot have been achieved without the passion and dedication of our employees around the world, and I look forward to providing you with future updates on our progress. With that, I'll now turn it back over to Tim and Giovanni for Q&A. David. Christina, could we go to our first question, please? Star One, again that's Star One.

Also help us with the impact that you are still seeing from.

The viral vector manufacturing and then a second question just on Opdivo. It was flat sequentially and how do you view.

Going into 2022 with respect to what.

<unk> could be more of a tipping point versus others. Thank you very much.

Thank you Jeff Thanks for the questions. This is Giovanni let me just stocked with a couple of comments and then I'll ask Chris to answer both of your questions. I just wanted to step back and really think about cell therapy and you'll remember in the past we had a number of discussions about.

Weather.

Cell therapy treatments would have fast uptake in the market place whether this market would grow overtime there were concerns.

Tim Power: And we will take our first question from Geoff Meacham with Bank of America. Hey guys, thanks for taking the question and congrats on a good quarter. I just wanted to ask about the new launches; the Avecma launch was pretty good.

With payers' willingness to provide coverage for those therapies and I must say when I look at the experience that we've had with both the beckman brands. It really confirms our belief that given the right.

Giovanni Caforio: Just give us a sense for how much of that is still bolus of patients, you know, versus underlying demand. And just also help us with the impact that you're still seeing from, you know, the viral vector manufacturing. And then the second question just on OnOptivo, it was flat sequentially.

Treatments with the right efficacy and safety profile that is tremendous willingness of physicians to prescribe.

Drive increased adoption in the marketplace.

Many of the payer dynamics have been resolved so you know.

Beyond obviously the question that Chris will answer as we look at the medium and the long term and the commitment we've made to our broad cell therapy portfolio I am very reassured that the commercial potential of this.

Giovanni Caforio: And, you know, how do you view, you know, going into 2022, with respect to, you know, what indications could be more of a tipping point versus others? Thank you very much. Thank you, Jeff. Thanks for the questions. This is Giovanni.

This modality is being recognized I would say significantly more than in the past Chris. So thanks for the questions. Jeff Let me start with cell therapy. So we are very pleased with the performance really of both <unk> and <unk> in the quarter. We saw a very nice increase in demand for both products there was some.

Giovanni Caforio: Let me just start with a couple of comments and then I'll ask Chris to answer both of your questions. But I just wanted to step back and really think about cell therapy. And, you know, in the past, we've had a number of discussions about whether cell therapy treatments would have a faster uptake in the marketplace, whether this market would grow over time. There were concerns with payers' willingness to provide coverage for those therapies.

Bolus for Beckman still.

Reflected in these numbers, but the underlying demand for that product looks very strong. The same is true with <unk>, we're very happy with the commercial execution for both of these products. We now have over 70 accounts that have been activated across both products and the majority of those accounts have been or plan to imminently use that use one or.

Giovanni Caforio: And I must say, when I look at the experience that we've had with both Abecma and Brianzi, it really confirms our belief that given the right treatments with the right efficacy and safety profile, there is tremendous willingness of physicians to prescribe and drive increased adoption in the marketplace, once many of the payer dynamics have been resolved. So, you know, beyond, obviously, the question that Chris will answer, as we look at the medium and the long term and the commitment we've made to a broad cell therapy portfolio, I'm very reassured that the commercial potential of this modality is being recognized, I would say significantly more so than in the past.

Both of the cell therapy products. So overall I would say the commercial performance continues to be very good.

As has been mentioned already we are actively managing the supply constraints those mainly are impacting our beckman as David mentioned in his remarks, we do anticipate that back.

Segment sales in the fourth quarter are going to be roughly similar to what we saw in the third quarter and we are of course, continuing to stay very focused on managing through the vector supply constraints and anticipated being in a much better position on that front as we get into the second half of next year, but again stepping back as Giovanni just mentioned, we are very happy with what we're <unk>.

Chris Boerner: So, thanks for the questions, Jeff. Let me start with cell therapy. So, we are very pleased with the performance, really, of both Abecma and Brianzi in the quarter. We saw a very nice increase in demand for both products. There was some bolus for Abecma still reflected in these numbers, but the underlying demand for that product looks very strong. The same is true with Brianzi.

Being in the marketplace on cell therapy, and it confirms the opportunity we have to build a strong position here with respect to Opdivo. The performance for the quarter for Io was really in line with expectations. We saw very strong double digit growth relative to same time last year, while sales were flat as you know from Q2 into Q3 that was as David mentioned a function of <unk>.

Chris Boerner: We're very happy with the commercial execution for both of these products. We now have over 70 accounts that have been activated across both products, and the majority of those accounts have used or plan to use one or both of the cell therapy products. So, overall, I would say the commercial performance continues to be very good.

Tori dynamics coming out of the second quarter. What is important here is that we had very solid growth in the quarter. We had solid growth relative to same time last year and quarter over quarter and that growth was in the key tumors that are going to drive near and medium term growth for the Io franchise, notably in gastric cancer, where we've seen a nice uptake.

The approval in April in renal cell cancer, we continue to see very strong demand and we've seen coming at the end of the quarter. Some nice growth in first line lung cancer. So overall, if you step back we were very confident not only in the continued growth for Opdivo. This year, but importantly, the momentum going into 'twenty two.

Chris Boerner: What is important here is that we had very solid growth in the quarter. We had solid growth relative to the same time last year and quarter over quarter, and that growth was in the key tumors that are going to drive near and medium-term growth for the IO franchise, notably in gastric cancer, where we've seen a nice uptake since the approval in April. In renal cell cancer, we continue to see very strong demand, and we've seen, coming at the end of the quarter, some nice growth in first-line lung cancer. So, overall, if you step back, we're very confident, not only in the continued growth for Opdivo this year but, importantly, the momentum going into 2022. Christina, could we go to the next question please?

Thanks, Chris Christina can we go to the next question. Please.

Yes, we will take our next question from Seamus Fernandez with Guggenheim.

Oh, great. Thanks for the question. So first one is on <unk>.

I just wanted to get a little bit of a better sense. It just seems.

Surprised to see that we don't have <unk> listed as filed yet.

I don't know what the.

Limitations are there new data being added.

Or that you plan to be added or is it just simply waiting for fda's acceptance of the filing.

The second question.

Really is as we think about the opportunity for <unk> I wanted to just get a better understanding of what.

Chris Boerner: We'll take our next question from Seamus Fernandez with Guggenheim. Oh, great. Thanks for the question. So the first one is on Ducravacitinib. I just wanted to get a little bit of a better sense. It just seems I was surprised to see that we don't have Ducravacitinib listed as FDA approved yet. Just don't know what the limitations are.

Bristol believe.

As necessary to succeed in ulcerative colitis, it's our understanding that.

90.

May in fact be the most critical part of the development plan.

Perhaps <unk> net may not achieve that unless the dose has really pushed.

Samit Hirawat: Are there new data being added? Or do you plan to add them? Or is it just simply waiting for FDA's acceptance of the filing? The second question, really, is as we think about the opportunity for Ducravacitinib, I wanted to just get a better understanding of what Bristol believes is necessary to succeed in ulcerative colitis. It's our understanding that the IC90 may, in fact, be the most critical part of the development plan, and that perhaps Ducravacitinib may not achieve that unless the dose is really pushed.

And so just wondering if you have a.

A long acting formulation, maybe something that that Brussels pursuing and then just a final question very quickly.

Yeah between your the MK two inhibitor the PTK inhibitor of the <unk> that you have in phase III would you call out any of these as having data.

2022 that we should be watching for.

Samit Hirawat: So just wondering if a long-acting formulation may be something that Bristol is pursuing. And then just a final question very quickly. Between the MK2 inhibitor, the BTK inhibitor, and the S1P1 that you have in Phase 2, would you call out any of these as having data in 2022 that we should be watching for? Thanks. Thank you, Seamus.

Thank you Seamus, let me ask Amit to answer your questions Seamus. Thank you for your questions on.

On the first one on <unk>, let me just first start by reiterating our confidence in the data, which differentiates it and establishes it as a potential.

Best oral therapy of choice in the future for patients with psoriasis in terms of the filing as you very well know we don't comment on when we file but we certainly do make it public when the file has been accepted validated after we have filed our fourth indication. So we will certainly make you aware and everyone over there.

Samit Hirawat: Let me ask Samit to answer your questions. All right, Seamus, thank you for your questions. On the first one on Dukrava, let me just start by reiterating our confidence in the data, which differentiates it and establishes it as a potential best oral therapy of choice in the future for patients with psoriasis. In terms of the filing, as you very well know, we don't comment on when we file, but we certainly do make it public when the file has been accepted and validated after we have filed for the indication.

When we hear.

As time goes, but having said that we do anticipate bringing the medicine to patients in the second half of 2022 as we have said before.

On the question on ulcerative colitis Youre right in the sense that the dose required in ulcerative colitis and Crohn's disease IBD in general is going to be two to three times higher than what we see for psoriasis and we've seen that for other molecules as well and that is the intent of the ongoing trials to test out these doses.

Samit Hirawat: So we will certainly make you aware and everyone aware as time goes by. But having said that, we do anticipate bringing the medicine to patients in the second half of 2022, as we have said before. On the question about ulcerative colitis, you're right in the sense that the dose required for ulcerative colitis, Crohn's disease, or IBD in general is going to be two to three times higher than what we see for psoriasis.

We obviously have not shared exactly what doses are being pursued for confidential reasons and competitive reasons, but we are looking at all.

Our avenues in terms of looking at the impact from not only PK, but the BD outcomes as well and we'll continue to follow those and those will be the real the ways to define a proof of concept in this disease for pursuing further.

Samit Hirawat: And we've seen that for other molecules as well. And that is the intent of the ongoing trials to test out these doses. We obviously have not shared exactly what doses are being pursued for confidential reasons and competitive reasons, but we are looking at all avenues in terms of looking at the impact of not only PK but the PD outcomes as well. And we'll continue to follow those, and those will be the ways to define a proof of concept in this disease for pursuing further in ulcerative colitis.

<unk> <unk>.

In terms of the MK two is lumpy one beat Teekay additional data those trials are ongoing as you know. These are these are in the phase Iia phase II settings, where we have multiple indications being pursued in <unk> in the same trial in the autoimmune space as lumpy. One also additional work being done and closed.

For example, as opposed to and for MK, two as well data is evolving I couldnt say that youll see the data in 'twenty, two or not but certainly we will make it available as soon as we have evolution of the clinical outcomes with these data.

Samit Hirawat: In terms of MK2, S1P1, BTK, and additional data, those trials are ongoing. As you know, these are in the Phase IIa, Phase IIb settings where we have multiple indications being pursued in BTK in the same trial in the autoimmune space. S1P1 also, additional work being done in Crohn's disease, for example, for Zyposia.

Thanks, Soma Christina can we go to the next question. Please.

Yes, we will take our next question from Chris Schott with J P. Morgan.

Hi, great. Thanks, so much just two questions from me maybe first.

This would be a lot of debate on the rate of Revlimid erosion in 'twenty, two and I know, you're not giving guidance for next year, but just any color. You can provide there are both U S and international dynamics and maybe specifically on the international side of the business is it reasonable thing about our business is down like 50%.

Samit Hirawat: And for MK2 as well, data is evolving. I can't say that you'll see the data in 22 or not, but certainly we'll make it available as soon as we have the evolution of the clinical outcomes for these data. Thanks, Tina.

For next year, given the low use you're facing or are you thinking of something much better or worse to that is just getting all of these things that I think we all have eroding over time, but I think just any color on the rate of erosion would be much appreciated.

Samit Hirawat: Could we go to the next question, please? We will take our next question from Chris Schott with JPL. Great. Thanks so much.

Giovanni Caforio: Just two questions for me. First, there seems to be a lot of debate about the rate of Revlimid erosion in 2022. I know you're not giving guidance for next year, but just any color you can provide there, both U.S. and international dynamics, and maybe specifically on the international side of the business. Is it reasonable to think about a business that's down like 50% for next year, given the LOEs you're facing, or are you thinking of something much better or worse than that? It's just, again, one of these things that I think we all have it eroding over time, but I think just any color on the rate of erosion would be much appreciated.

And then the second question is a bigger picture one.

You've been steadily rebuilding the portfolio here, but <unk> had a stock that has underperformed. This year I think the street remains concerned on some of these longer term Hello.

Does that at some point lead to I guess.

A more aggressive deployment of your capital whether that's a step up in BD look at larger maybe later stage deals or even go the other direction with more aggressive share repo I'm trying get a sense of when you look at you know what I think you would think of as a disconnect between what's fundamentally happened with your business and the stock price like how do you. How do you kind of think about starting to address that.

Thanks very much.

Giovanni Caforio: And then the second question is a bigger picture one. You've been steadily rebuilding the portfolio here, but you have had a stock that's underperformed this year, and I think the street remains concerned about some of these longer-term LOEs. Does that at some point lead to, I guess, you know, a more aggressive deployment of your capital, whether that's a step up in BD, a look at larger, maybe later stage deals, or even going the other way with more aggressive share repo?

Thank you, Chris Let me, let me take your questions.

Giovanni So first of all on Revlimid generic entries.

Nothing has changed there and let me just reiterate what we've said before.

What we see happening next year.

So.

Next year, we will begin to see a volume limited generic competition in the U S.

And at the same time, we expect to see generic entries for Revlimid ex U S.

Giovanni Caforio: I'm just trying to get a sense of when you look at, you know, what I think you would think of as a disconnect between what's fundamentally happened with your business and the stock price. Like, how do you kind of think about starting to address that? Thanks very much.

That's consistent with what has always been our understanding has not changed its been fairly clear.

Our filings and we're preparing for that.

The second thing that I would like to say is that if you remember beginning of J P. Morgan, we clearly articulated how we think about the company.

Giovanni Caforio: Thank you, Chris. Let me take your questions here, Giovanni. So first of all, on rev limit generic entries, you know, nothing has changed there. And let me just reiterate what we've said before and what we see happening next year. So, you know, next year, we will begin to see volume-limited generic competition in the US, and at the same time, we expect to see generic entries for REVLIMIT-X UI.

During the period of loss of exclusivity for Revlimid and polished.

And we expect to be able to grow the company in fact that we've articulated.

Low to mid single digit for the total company.

Low double digits for our continuing business through.

Through 2025.

And when we provided that perspective.

Giovanni Caforio: That's consistent with what has always been our understanding, it has not changed, it's been fairly clear in our filings, and we're preparing for. The second thing that I would like to say is that, you know, when we began at J.P. Morgan, we clearly articulated how we think about the complex during the period of loss of exclusivity for Revlimid and POMA, and we expect to be able to grow the company. In fact, we've articulated low to mid single-digit growth for the total company and low double-digit growth for our continuing business through 2025.

We we obviously were.

Reflecting our understanding of the Revlimid erosion and I think the conviction that we have that we can continue to grow the company is really driven by the belief, which is proving right that the combination of strong growth from our in line products.

<unk> Opdivo and illiquid combined with the strong uptake of our launch brands, which is happening would more than offset the loss of exclusivity of Revlimid internationally next year, and then overtime in the U S. So while I'm not going to give you.

Giovanni Caforio: And, you know, when we provided that perspective, we were obviously reflecting our understanding of the rev limit erosion. And I think the conviction that we have that we can continue to grow the company is really driven by the belief, which is proving right, that the combination of strong growth from our in-line products, namely Optivo and Eloquist, combined with the strong uptake of our launch brands, which is happening, would more than offset. The loss of exclusivity of Revelimid internationally next year and then over time in the U.S. So I'm not going to give you exactly a percentage of erosion for next year.

Exactly a percentage of erosion for next year.

And we definitely will have an opportunity to talk more about this when we eventually provide guidance for the year. What I can tell you is that our belief remains strong and I think that our perspective that we are able to grow sales and earnings per share applies to next year as well.

And so nothing is really nothing has really changed there now with respect to your second question.

That speaks to what are our priorities as we renew the portfolio in the face of Eloise Ah first of all I think we have a rapidly evolving portfolio of new medicines.

That has tremendous potential.

Giovanni Caforio: And we definitely will have an opportunity to talk more about this when we eventually provide guidance for the year. But what I can tell you is that our belief remains strong, and I think that our perspective that we are able to grow sales and earnings per share applies to next year as well. And so nothing has really changed.

Where we are executing multiple launches well and I think our priority is always going to be first to maximize the opportunity that we have in a very very leach late stage pipeline at the same time, we have tremendous financial flexibility as David said.

Giovanni Caforio: Now, with respect to your second question, that, you know, speaks to what our priorities are as we renew the portfolio in the face of LOEs. First of all, I think we have a rapidly evolving portfolio of new medicines. [inaudible] At the same time, we have tremendous financial flexibility. And, you know, obviously, we've seen for, and we've said for some time now, that business development is a priority for us as we think about allocating capital. And that continues to be the case.

And.

Obviously, we've seen we've said for some time now that business development is a priority for us as we think about allocating capital and that continues to be the case.

At the same time as I've said before we will be disciplined as we think about the BD <unk>.

We do have many opportunities.

To deploy our capital to accelerate growth and I also believe.

That our capital allocation strategy will continue to be.

Balanced where as David mentioned, we have a history to Lee.

Giovanni Caforio: At the same time, as I've said before, we will be disabled. I'm very happy to be here today to talk to you about capital allocation and how it can be used in the long term as we think about BD because we do have many opportunities to deploy our capital to accelerate growth, and I also believe that our capital allocation strategy will continue to be balanced where, as David mentioned, we have a history to look at our dividend, and we have increased our dividend consistently over the last several years. We've done that double digit in the last couple of years.

Look at our dividend and we have increased our dividend consistently over the last several years, we've done that double digit.

In the last couple of years.

And looking at share repurchases year to date, we've repurchased $3 5 billion, we have an existing authorization for another.

$3 billion.

This year and obviously, we'll continue to look at that as well.

But I can tell you that of course I understand the focus on that Louise.

At the same time as.

We believe that we are executing.

Giovanni Caforio: And looking at share repurchases, year to date, we've repurchased three and a half billion shares; we have an existing authorization for another three billion this year. And obviously, we'll continue to look at that as well. But I can tell you that, of course, I understand the focus on LOEs.

On a plan to renew our portfolio and we have tremendous financial flexibility to continue to make the right moves to do that.

Cynically go to our next question please.

Our next question from Tim Anderson with Wolfe Research.

Thank you a couple of questions lag three when can we expect that youll have overall survival data in hand in melanoma.

Giovanni Caforio: At the same time, we believe that we are executing really well on a plan to renew our portfolio, and we have tremendous financial flexibility to continue to make the right moves. Can we go to our next question, please? Q&A. Thank you. A couple of questions.

For the package you have already submitted and can you update us on what the development program looks like from here in terms of new trials and new tumor types.

If I look at Roche with <unk>, they pushed into lots of Registrational trials for lots of different tumors kind of all at once and I'm wondering why we're not seeing Bristol will do the same here.

Giovanni Caforio: LAG-3, when can we expect that you'll have overall survival data in hand for melanoma for the pack? And can you update us? The Bulletproof Executive 2013, If I look at Roche with Tidget, they pushed into lots of registrational trials for lots kind of all at once. I'm wondering why we're not, signal that you're coughing. Survival Datum, and then the second question on MAVIC-CAMPTOM. Last quarter, I asked a question. Why you got it. I didn't quite understand... 2019.

No thats your confidence just isn't there yet and this molecule and that the survival data in melanoma is a gating factor.

And then second question on <unk> last quarter I asked a question why you got only a standard review when it was awarded breakthrough therapy designation previously.

Didn't quite understand your answer but in 2019 was pretty clear you expect into 2000 22021 approval and launch.

Samit Hirawat: It was pretty clear to you, So I'm going to re-ask it here, are you co- Sure. Thank you, Tim. Let me ask Samit to answer both of your questions, LAC-3 and Mavakampton. Sure. Thank you, Tim.

Im going to re asking here are you confident you have an approvable drug at the Paducah date or is there a potential that they would want additional data and youll get a CRO.

Sure. Thank you, Tim let me ask Sam.

Summit to answer both of your questions luxury MFA Campton sure. Thank you Tim.

For lag three.

Samit Hirawat: For LAC-3, overall survival data, of course, is dependent on the events, and we are going to continue to follow them, and we'll share the data once available at a medical conference, but certainly make you aware of it. We have to remember, though, that in IO therapies, more important than those hazard ratios is going to be the shape of the curve, and we're going to continue to watch out for that, and we'll share that when it becomes available. I cannot tell you exactly what the timing will be at the moment. From a development program perspective, yes.

Overall survival data of course is dependent on the event and we're going to continue to follow them and we'll share the data once available through a medical conference, but certainly make you aware of it we have to remember, though that in Io therapies more important than those hazard ratios are going to be the shape of the curve and we're going to continue to watch out for that.

And we'll share that when that becomes available I cannot tell you exactly what the timing would be at this time.

From a development program perspective, yes, the first aligned melanoma study read out we submitted we have a <unk> date for March of 2022, we have initiated the adjuvant trial in melanoma at this time, we have a randomized phase II study ongoing in non small cell lung cancer and plan to initiate phase III trials.

Samit Hirawat: The first aligned melanoma study read out. We submitted it. We have a PDUFA date for March of 2022, and we have initiated the adjuvant trial in melanoma at this time. We have a randomized phase two study ongoing in non-small cell lung cancer and plans to initiate phase three trials late this year, meaning at the end of this year or early next year. And we have a randomized trial ongoing in hepatocellular carcinoma as a proof of concept generation. LAG-3, as you know, has had a history for a long time where we didn't have any data.

Later this year are meeting at the end of this year or early next year.

And we have a randomized trial ongoing in competitive cell carcinoma is a proof of concept generation.

Lastly, as you know has had a history for a long time, where we didn't have any data. So one has to ensure that the proof of concepts that we are following are going to be strong and we believe that the trials that we have ongoing will give us that data to go forward four digit if you recall.

Samit Hirawat: So one has to ensure that the proof of concepts that we are following are going to be strong, and we believe that the trials that we have ongoing will give us that data to go forward. For TIGIT, if you recall, there was a proof of concept in non-small cell lung cancer, and that is a different tumor type and a different milieu in terms of the tumor microenvironment.

That is the proof of concept in non small cell lung cancer and that is a different tumor type in different menu in terms of the German microenvironment. So we have to sort of judge the scientific data and put that in that perspective, as we look for new tumor types to explore.

Samit Hirawat: So we have to judge the scientific data and put that in that perspective as we look for new tumor types to explore. And we'll certainly keep you posted if new tumor types are added to the LAG-3 program. For Maverick Hampton, we are certainly comfortable with the data that we have from the Explorer trial, from the efficacy perspective, as well as the safety perspective. We have a PDUFA date for January of next year.

And we'll certainly keep you posted if new tumor types that are added and the lag three program as well.

<unk>, we are certainly comfortable with the data that we have from the explorer trial from the efficacy perspective, as well as safety perspective.

Have a <unk> date for January of next year.

I have not heard from.

Samit Hirawat: We have not heard from the FDA in terms of what additional data would be required. We certainly do not comment as to what the outcomes will be and how the ultimate decisions will be made by the agency, but we continue to engage with them. And as is usual for any filing, the back and forth and answering questions continues, but that is not unusual as we look at Maverick Hampton or any other trial. Sunny, can we go to the next question, please? We'll take our next question from Hector with Berenberg.

The FDA in terms of what additional data would be required we certainly don't comment as to what the outcomes will be and how the ultimate decisions will be made by the agency, but we continue to engage with them and as is usual for any filing the back and forth and answering questions continues but that is not unusual.

As we look at <unk> any other drug.

Christine can we go to the next question. Please.

We will take our next question from Luisa Hector with Bahrenburg.

Samit Hirawat: Hello, thank you for taking the time to answer my questions. I wanted to check on Ducravacitinib, whether you have started hiring your dermatology salesforce already, or whether this is now Q4 and the reasons for the phasing of the marketing cost into Q4 from Q3, and maybe you could also update us on where you are with your cost savings or where you plan to be by the end of this year and what kind of increment we could see in 2022 given the revenue generic impact as well, just to think Thank you.

Yeah.

Thank you. Thank you for that question.

I wanted to check on the geographic <unk> Smith, whether you have started hiring your dermatology sales calls already or whether this is.

Now the Q4 level.

The marketing costs from Q4 Q3.

Maybe you could also update us on where you are with your programs.

What are your plans.

And what kind of improvement we could see.

In 2022.

Yes.

Generic impact as well just to think about the phasing.

Thank you.

Thank you so let's start with <unk>.

Chris Boerner: Thank you. So let's start with Ducrava, commercial investment in preparation for the launch, and Chris and then David on synergies.

Commercial investment in preparation of our launch Chris and then David on synergies sure. Thanks for the question, we are well on our way to building out the U S commercial and medical teams and feel great about the quality of the team that we're pulling together as well as the commercial readiness.

Chris Boerner: Sure. Thanks for the question. We are well on our way to building out the U.S. commercial and medical teams and feel great about the quality of the team that we're pulling together as well as the commercial readiness. The medical teams have actually been in place for a number of months. We've managed to hire a very strong team with deep dermatology experience there. Key in-office roles have been filled, and they're in the process of executing against launch plans, and we are building out the sales teams now. David?

The medical teams have actually been in place for a number of months.

One is to hire a very strong team with deep dermatology experience their key in office roles have been field and they are in the process of executing against launch plans and we are building out the sales teams now.

David Greene and thank you for your question on synergies the execution on the integration continues to go extremely well.

David V. Elkins: Great. And thanks for the question on synergies. The execution on the integration continues to go extremely well.

As we indicated before we will over deliver initial commitment we're now at $3 billion.

David V. Elkins: As we indicated before, we will over-deliver our initial commitment. We're now at $3 billion. By the end of this year, we anticipate being about $2.5 billion, which you may recall was the original overall commitment. So as we head into next year, getting to that $3 billion is what we're targeting. So good execution and continued overachievement of our initial expectations on the Synergies.

By the end of this year, we anticipate being about $2 5 billion, which you may recall was the original overall commitment.

So as we head into next year.

Getting to that $3 billion is what we're targeting so good execution and continued over achievement of our initial expectations on the synergies.

Thanks, David Christina can we go to the next question. Please.

David V. Elkins: Thanks. David, Christina, can we go to the next question, please? Our next question is from Andrew Baum. Yeah, thank you.

Our next question will come from Andrew Baum with Citi.

Yes. Thank you.

First question is on that.

Number one could you just update us on that.

Giovanni Caforio: First question is on TIC-2. Number one, could you just update us on the additional maturing data sets in terms of what you're seeing from zoster, cardiovascular as well as malignancy, if anything? And also, perhaps you could comment on, in light of the recent FDA comments for JAX and RA, how you are thinking about potential labeling for TIC-2s? Obviously, there's a continuum of potential labels, some very unfavorable, some obviously more favorable. And second, in relation to your analyst meeting that is coming up, to what extent will you be able to talk about your phase three program for your factor 11a inhibitor? Or will we have to wait until you have the arterial data in hand next year before you and your partner can talk?

The additional maturing data set some standards of what youre seeing from <unk>.

Cardiovascular as well as particularly to see if anything.

And also perhaps you could comment on the likes of the.

Recent FDA comments.

Jackson.

How are you thinking about potential labeling could take two is obviously you guys continue with potential label. Some very unfavorable some obviously more capable and then second in relation to your analyst meeting that is coming up to what extent would you be able to talk CEO phase III program for your Acura 11 a M.

EBITA.

Or will we have to wait and you have the serial data in hand next year before you and your partner can talk to.

Samit Hirawat: and your partner can talk to you about the overall Phase 3 trial program. Thank you.

The April phase III trial program. Thank you.

Giovanni Caforio: Sure, Andrew, let me just start by giving you a perspective on the investor meeting, and then we'll ask Samit to comment on the TIC2 program. So, as we think about getting together in the middle of November, the objective is really primarily to give you an update on everything that has happened in the company and our portfolio over the last few years.

Sure Andrew Let me just start by by giving your perspective at the Investor meeting.

And.

And then we will.

Ask summit to comment on.

On the tier II program so.

As we think about getting together in the middle of November is the objective.

It's really primarily to give you an update on everything that has happened in the company and our portfolio over the last two years. It will be two years since we closed the acquisition of Celgene and <unk>.

And a lot has happened.

So we will talk about the progress with the pipeline some of the late stage programs to the commercial opportunities we see from the asset will talk about the outlook for the company.

Samit Hirawat: And so we'll talk about the progress with the pipeline, some of the late-stage programs, the commercial opportunities we see from the asset, and we'll talk about the outlook for. Specifically, there will be an opportunity to focus on a few of those. So, for example, as you know, the milvexian data will be presented at AHA just before our meeting, and we look forward to discussing that update with you. We're also making progress in another area, which is hematology, and that includes the cell modes and the Brianzi second line data that were mentioned earlier.

Specifically.

There will be there will be an opportunity to focus.

On a few of those so for example, as you know the mill vaccine data will be presented at <unk>, just before our meeting and we look forward to discussing.

That update with you we're also making progress in another area, which is hematology.

And that includes the <unk>.

<unk> margin debris NZ second line data that were mentioned earlier they are expected to be at ash, and we'll have an opportunity to review.

Samit Hirawat: They are expected to be at ASH, and we have an opportunity to review them at the event. So these are just some of the examples of the updates that we're planning on discussing at the meeting, which includes some of the data sets that you will see. Thank you. In regards to the TIK2 inhibitor, the long-term data that we continue to follow these patients, As you've seen, we don't see the profile differentiating in any other way than what we've already disclosed before. We believe this is a TIK2 inhibitor with not having a jack-like signature.

Those at the event. So these are just some of the examples.

Of the updates that were.

Planning on discussing it at the meeting and that includes some of the datasets that you were referencing.

Summit, yes. Thank you in regards to the <unk> two inhibitor. The long term data that we continue to follow these patients and we've seen we don't see the profile differentiating in any other way than what we've already disclosed before but we believe this is a <unk> two inhibitor but.

Not having a JAK like signature the overall profile from the lab parameters perspective, cardiovascular perspective infections perspective remains stable as the data had been shared before so we are looking forward to continuing the engagement with the agencies as we go forward and looking to bring it to patients in the second half.

Samit Hirawat: The overall profile from the lab parameters perspective, the cardiovascular perspective, and the infections perspective remains stable as the data have been shared before. So we are looking forward to continuing the engagement with the agencies as we go forward, and we're going to bring it to patients in the second half of next year. As far as the jack and labeling in RA as well as other conditions are concerned, again, these are going to be in the future as we go into discussions with the regulatory agencies about how we see it. We don't see it as a jack inhibitor, so we're not really thinking about it like that.

Of next year.

As far as the Jack and labeling and <unk> as well as other conditions are concerned again these are going to be in the future as we go into discussions with the regulatory agencies that we see it we don't see it as a JAK inhibitor. So we're not really thinking.

Thinking about it like that.

We'll continue to update you once we get more sound.

Samit Hirawat: We'll continue to update you once we get a more sound place in terms of advice. Thanks, Samit. Christina, can we go to the next question, please?

Place in terms of advice if data they need to be sure.

Thanks Senate Christina can we go to the next question. Please.

And our next question from Carter Gould with Barclays.

Chris Boerner: Great. Good morning. Thanks for taking the question. First, I guess maybe to start commercial, I'm hoping you could add maybe a little bit more in terms of anything tangible on sort of UC demand with Zeposia and to what extent the start of the year will be sort of an important milestone in terms of broadening access. And then maybe just a clarifying question on Dick Kravosytny, Samit, you talked about: https://www.kenhub.com. Are you exploring something above and beyond sort of the 12 meg that I think was the high end? And then I know it's a bit of a sensitive topic given some of the ongoing litigation, but, you know, just maybe how you're thinking about sort of the backup TIC-2 compounds you Short.

Great. Good morning, Thanks for taking the question first I guess maybe start commercial.

Hoping you could add maybe a little bit more.

In terms of anything tangible on sort of you see demand was as opposed to you and to what extent the start of the year will be sort of an important milestone in terms of broadening access and then maybe just a clarifying question on <unk>.

You talked about.

And you see needing to explore doses two to three times higher than what's active in psoriasis art I know you don't want to get into specific doses, but.

Are you exploring something above and beyond sort of the 12 make that I think was the high end in the psoriasis study and then I know, it's a bit of a sensitive topic given some of the ongoing litigation but.

Just maybe how youre thinking about sort of the backup TIK two compounds you have in your portfolio. Thank you.

Chris Boerner: Chris, why don't you start on you? Yeah, so we feel very good about the performance that we're seeing for Zipozi in UC. And let me start with execution. The execution of the team really since approval has been very strong. We've got very good awareness for the product. The unaided awareness is now over 60%. Aided awareness is well over 90%. Since approval in UC, we estimate that we have around 400 trialists that have already begun to utilize the product.

Sure.

Chris Why don't you why don't you start on UC.

Youll see demand. So we feel very good about the performance that we're seeing for as opposed to in UC and let me start with execution. The execution of the team really since approval has been very strong we've got very good awareness for the product. The unaided awareness now is over 60% aided awareness is well over 90% since approval in <unk>.

You see we estimate that we have around 400 trials that have already begun to utilize the product virtually all of the gastro that we survey who are aware of as opposed <unk> are interested in trying it and frankly in spite of a still relatively restricted access environment. The sales teams are having very good success in engaging with customers both in Peru.

Chris Boerner: Virtually all of the gastros that we surveyed who are aware of Zipozi are interested in trying it. And frankly, in spite of a still relatively restricted access environment, the sales teams are having very good success in engaging with customers both in person and remotely.

And remotely so from an execution standpoint is early days, but we feel very good about where we are as you note access is going to be continue to be something we pay a lot of attention to we feel good about our ability to start generating volume this year and into the first part of next year and we think that volume will build momentum as we get into the second half of 2022.

Chris Boerner: So from an execution standpoint, it's early days, but we feel very good about where we are. As you note, access is going to continue to be something we pay a lot of attention to. We feel good about our ability to start generating volume this year and into the first part of next year.

Chris Boerner: And we think that volume will build momentum as we get into the second half of 2022 when we begin to get additional, more favorable access with key payers. But so far, the UC performance that we're seeing commercially is very, very strong, and we are very happy with where we are. Thank you, Chris.

When we begin to get additional.

More favorable access.

With key payers, but so far the UC performance that we're seeing commercially is very very strong and very happy with where we said thank.

Thank you Chris.

Before I ask summit to comment on the <unk> dose.

Giovanni Caforio: Before I ask Samit to comment on the Ducrava dose, let me just say, Carter, we're not going to comment on any ongoing litigation. I just want to say that that litigation is really not related at all to the BMS program or any backup that may exist that completely, and there is no relation. Yeah, and just a minor thing to add here is, as we talk about the doses, without getting into the specifics of it, I can tell you that we selected the doses which are higher than what we used in the psoriasis program, based on PK modeling and taking into account the historical experience. We will certainly say that at this point, we don't know if these higher doses will translate into efficacy or not That's the proof of concept we're trying to get.

Just take after we are not going to comment on any ongoing litigation I. Just wanted to say that that litigation is really not related at all to the BMS program or any backup that may exist, so they're completely different.

Programs and there is no relationship there yeah, and just a minor thing to add over here as we talk about the doses without getting into the specifics of it I can tell you that we selected the doses, which are higher than what we used in the size of this program based on PK modeling and taking into account the historical experience.

We will certainly say that we at this point.

Don't know if these higher doses will translate into efficacy or not that's the proof of concept. We are trying to get and once that is available that will certainly pave the way for the future program, we will need to see what the data are from the next trials that we are pursuing right now both in crohn's disease as well as in ulcerative colitis.

Samit Hirawat: And once that is available, that will certainly pave the way for the future program. We will need to see what the data are from the next trials that we are pursuing right now, both in Crohn's disease, as well as in other, Can we go to our next question, please? Yes, we'll take our next question from Ronnie Gao. Good morning, and thank you for taking the questions. The first one is in the PD-1 space.

Okay can we go to our next question. Please.

And we will take our next question.

Ronny Gal with Bernstein.

Good morning, and thank you for taking the questions first one is on the PD one space, there's been some debate about the approval ability.

Follow on PD, one with data from Asian populations only.

Obviously generated a lot of data and various pop.

Giovanni Caforio: There's been some debate about the approvability of full-on PD-1s with data from Asian populations only. You've obviously generated a lot of data in various populations. I was wondering if there was any scientific basis to this concern.

Populations and I was wondering if there is any scientific basis that is concerned that is in your travels is there a difference in either efficacy or safety.

In different ethnic populations with your PD one.

And second on Washington.

The discussion around.

Price reform and the drug area it seems to be clear that the negative scenario. So the industry will not play out but there is still some discussion.

Our pharma contributing to catastrophic insurance and part D and if there will be price negotiations the discussion seems to be focused on part b as in boy given that you're more exposed to the oncology space I was wondering if there's any basis for that that is there a risk of that oncology will take the brand into <unk>.

Giovanni Caforio: That is, in your trials, is there a difference in efficacy or safety in different ethnic populations with your PD-1? Second, on Washington and the discussion around the impact of the D.C. whatever giveaways they are taking, or will it be more balanced across product types? Thanks, Ronnie.

Off the.

The impact of the D C.

Never give away so taking all of that will be more balanced across that.

Cost of that product types.

Thanks, Ronny, let me just start there and then I'll ask.

Giovanni Caforio: Let me just start there, and then I'll ask Samit to comment on your question about PD-1 development. So, let me just start by saying that it's really difficult to forecast at this point what price reform may look like in the future. From my perspective, what's important is that any change that is made actually improves affordability of medicines for patients, and that's the lens that we are applying. And from that perspective, there are a number of elements of potential reform like establishing the auto pocket, https://www.youtube.com.au. It's very difficult to answer your question with respect to whether a disproportionate impact may happen in oncology or not.

Summit.

To comment on your question about PD one development. So let me just start by saying that it's really difficult to forecast at this point to what price here for May look like in the future from my perspective.

What's important is that any change that is made actually improves affordability of medicines for patients and that's the lens.

That we are applying and from that perspective, there are a number.

Elements of potential reform alike, establishing auto pocket caps and par.

The redesign of the <unk>.

Benefit.

To reduce.

To reduce the exposure of patients that.

That we support and we also support.

Some changes like introducing market forces in part B.

Very difficult to answer your question with respect to weather a disproportionate impact in may happen in oncology or not I think what's important is that we don't go to reforms.

Giovanni Caforio: I think what's important is that we don't go to reforms that actually impact the ability of the industry to continue to invest in innovation, and that's the primary, the primary lens. You know, I think from the perspective of the BMS portfolio, when you look at our portfolio, it is actually very diversified across therapeutic areas, across actually Part B versus Part AA, and so I can't speculate what the impact will be. [inaudible] Yeah, man, just starting from where you left off in terms of the portfolio, we have a very broad portfolio, which means that when we conduct our clinical trials, we do them globally, including those in Asia. And when we file the data, we have to provide subset analysis by region or sometimes even by country, and that's how we seek approval in some of the regions and countries of the world, including Asia.

Actually impact the ability of the industry overall to continue to invest in innovation and that's the.

The primary the primary lens here.

I think from the perspective of the BMS portfolio. When you look at our portfolio. It is actually very diversified across therapeutic areas across actually part b versus spot.

And so I can't speculate what the impact.

Any reform would be on us.

What's really important is to continue to advocate for reforms that yes improve affordability of medicines for patients, but at the same time enable us to continue to invest in innovation and some of the hyper partisan.

<unk> is being discussed in Washington would actually impact both negatively.

Yes, and just starting from where you left off in terms of the portfolio. We have a very broad portfolio, which means that when we conduct our clinical trials, we do them globally, including those in the Asian countries and when we file the data we have to provide subset analysis by region or sometimes even by country and Thats, how we seek approval in some of the regions and countries.

The world, including in Asia.

As it comes to the PD, one inhibitors, where we have conducted clinical trials globally and across the <unk>.

Giovanni Caforio: As it comes to the PD-1 inhibitors, where we have conducted clinical trials globally and across the 20-odd indications or 12-plus tumor types that have now sought approval, we don't see a major difference occurring because of regional differences or population differences. However, that doesn't mean that representation of larger populations may not be required in clinical trials. So one has to just keep that in mind rather than think about whether a singular country trial will lead to approval. Christina Caligo for our next question. Our next question is from Matthew Harrison with Morgan Stanley. Good morning. Thanks for taking the questions. I guess two for me.

Our 12, plus tumor types that have now.

Sought approvals.

Don't see a major difference occurring because of regional differences or population differences that doesn't mean that.

Presentation of larger populations may not be required in clinical trials. So one is to just keep that in mind, rather than thinking about a singular country childhood lead to approvals or not.

Kristina glucose next question please.

We'll take our next question from Matthew Harrison with Morgan Stanley.

Great. Good morning, Thanks for taking the questions I guess I guess two for me so first on.

Chris Boerner: So first, on the second line CAR-T study, I'm just wondering how you think you need longer term follow-up to compare to transplant for that to be commercially successful. And then, as we look at the data coming at ASH, I think we're going to get data from the KITE study as well, so I'm wondering if there's any differentiation you're looking for between your product versus those.

On the second line car T study I'm, just wondering how youre thinking about that commercially and specifically, whether you think you need longer term follow up to compare to transplant.

For that to be commercially successful and then as we look at the data coming at Ash I think we're going to get data from <unk> study as well I'm wondering if there's any differentiation youre looking for your product versus those and then and then second on supposedly.

Chris Boerner: And then, second on Supposia, I'm just wondering if you could talk about, or you've thought about, if Biogen wins their appeal on Tecfidera and branded Tecfidera comes back to the market, does that change any of your assumptions and how you think about the MS market? Thanks. Thank you. Matthew. Let me start with Chris, and maybe I can make a comment on Zypros

I'm just wondering if you could talk about or you've thought about if biogen wins their appeal on <unk>.

Branded <unk> comes back to the market does that change any of your assumptions on how you think about the EMS market. Thanks.

Thank you Thanks, Matt Matthew let me start with Chris just maybe a comment on symposia.

And then and then we can move to the second line car T data and some of it will add some comments, yes. So just on as opposed to you very quickly.

Chris Boerner: And then, and then we can move to the second line: CAR-T data and Samit. Yeah, so just on Zeposia very quickly, we have, we don't anticipate that any potential change on the TechFedera side would have an impact on us. We've seen very limited competitive impact of generic TechFedera.

We have.

We don't anticipate that any potential change on the <unk> side would have an impact on us we have seen very limited competitive impact of generic tech vadera.

Thats prominently been cannibalization of branded Tech and then obviously a shift in.

Chris Boerner: That's primarily been cannibalization of branded tech and then obviously a shift in the utilization within the BAT portfolio. Our focus on Zeposia and the MS side continues to be not only a way of establishing ourselves as the number one SP, which we are right now in terms of written scripts, but also becoming the number one oral. And so our focus will continue to be in a very disciplined way focused on that.

Utilization within that portfolio, our focus on as opposed to in the EMS side continues to be not only establishing ourselves as the number one SP, which we are right now in terms of written scripts.

But also becoming the number one oral and so our focus will continue to be in a very disciplined way focused on that.

Let me just give the commercial perspective on the second line car T study and then I'll turn it over to summit. When you look at that second line setting generally.

Chris Boerner: And let me just give the commercial perspective on the second line CAR-T study and then I'll turn it over to Samit. When you look at that second line setting generally, you generally see that population divert into those positions who tend to be very focused on transplant. There's a sort of defined segment of those physicians. There are a number of physicians who are very open and look for opportunities to avoid transplantation where possible. And then there are a number of physicians who really take it on a case-by-case basis.

You generally see that population divert into those physicians who.

Tend to be very focused on transplant, there's a sort of defined segment of those physicians there are number of physicians who.

Are very open and look for opportunities to avoid transplant, where possible and then there are a number of physicians who.

Really take it on a case by case basis and so we're excited about the data that we've seen so far.

Chris Boerner: And so we're excited about the data that we've seen so far and look forward to seeing that data continue to play out and be presented at ASH. And we'll obviously adjust accordingly from a commercial perspective. Yeah, and just continuing that excitement from a data perspective, we truly are looking forward to sharing the data at ASH from the second line study. EFS, in this particular case, is an accepted endpoint from a regulatory perspective.

And look forward to seeing that data continue to play out and be presented at ash and we'll adjust obviously accordingly from a commercial standpoint, and discontinuing that excitement from a data perspective, we truly are looking forward to sharing the data at ash.

From the second line study.

And in this particular case is accepted endpoint from a regulatory perspective. So we're looking forward to certainly getting engagement with the agency and getting this again to the patients as soon as possible. We will obviously continue to follow patients for overall survival and as the as is required for card cell therapy as long term safety follow up as well so those data.

Samit Hirawat: So I'm looking forward to certainly getting engagement with the agency and getting this again to the patients as soon as possible. We'll obviously continue to follow patients for overall survival, and as is required for cell therapy, long-term safety follow-up as well. So those data will evolve and will be shared in the future.

Well then will be shared in the future at the current time. The primary endpoint of this study was <unk> and we have that in hand and that will be presented.

Samit Hirawat: At this time, the primary endpoint of this study was EFS, and we have that in hand. Can we go to the next question, please? We'll take our next question from Steve Scala with Cowan. Thank you. A couple questions.

Thanks, So much Christina can we go to the next question. Please.

And we'll take our next question from Steve Scala with Cowen.

Thank you a couple of questions lupus seems like an area of strategic interest to the company. This Bristol CEO. It has all the assets it needs and lupus or would you look for M&A to supplement this area. So that's that's one question second question is on the factor 11 eight.

Samit Hirawat: Lupus seems like an area of strategic interest to the company. Does Bristol feel it has all the assets it needs in Lupus, or would you look for M&A to supplement this area? So that's one question.

Samit Hirawat: Second question is on Factor 11a data at AHA. It was mentioned on this call that the company is excited about what we're going to see. On the second quarter call, Samit, you noted that the data we're going to see is, So should we conclude that what we will see at AHA is that you have the phase three dose and it is proven safe, or might we see more than that?

At a J. It was mentioned on this call that the company is excited about what we're going to see on the second quarter call you noted that you're about.

I want to see is dose finding with safety data.

So should we conclude that what we will see any AAJ is that you have the phase III dose and then it is proven safe or might we see more than that thank you.

Samit Hirawat: Thank you. Thank you. Samit, do you want to take both?

Thank you next time it will take both sure absolutely. Thank you Steve for your questions and some starting with lupus as you know that we will first of all I will get the data for <unk> S. L E at the beginning of next year.

Samit Hirawat: Sure. Absolutely. Thank you, Steve, for your questions. And starting with Lupus, as you know, we will, first of all, get data for Dukrava Citadel in SLE at the beginning of next year. We have a discoid lupus study that is also ongoing, which we'll read out in 23 or later part of that. We have a couple of other assets in early development, which are on control.gov, where we have ongoing studies looking at lupus as well.

We have a discoid lupus study that is also ongoing which will read out in 2003 or.

Later part of that we have a couple of other assets in early developments, which are <unk>, which we have ongoing studies looking at lupus as well. So we do believe that we've covered a broad range of targets and broad range of medicines being explored in lupus and one of those are several of those could be pursued for the future.

Samit Hirawat: So we do believe that we've covered a broad range of targets and a broad range of medicines being explored in lupus, and one of those or several of those could be pursued for the From an 11A perspective, from Melvixian, as we've said, at AHA, you'll see the data. And there are two things to really take away.

From an 11, a perspective for <unk> as we've said at IHA Youll see the data and there are two things to really.

Takeaway one the intent of the study was to define a range of those that will be pursued for future evaluation in phase III. Once the data from SSP study is also available so that collective data set then leads to the decision making for our future exploration indications as we go forward.

Samit Hirawat: One, the intent of the study was to define a range of those that will be pursued for future evaluation in Phase 3 once the data from the SSP study is also available so that the combined data set then leads to the decision making for future exploration and indications as we go forward. Second, we wanted to see a differentiation in terms of not only efficacy but, very importantly, from a safety and bleeding risk perspective.

We wanted to see a differentiation in terms of not only efficacy, but very importantly from a safety and bleeding risk perspective, and when we think about that it is going to be important to pay attention to major bleeds.

Samit Hirawat: And when we think about that, it is going to be important to pay attention to major bleeds and minor bleeds and overall bleeds. So those are the kinds of things that you probably will see at AHA, and then we can certainly have a discussion about them in the middle of next month when we have the presentations at the end. Christina, can we go to the next question, please?

And minor bleeds and overall so those are the kinds of things that you probably will see at <unk> and then we can certainly have a discussion in the middle of next month when we have.

The presentations with investors meeting.

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

We will take our next question from Dane Leone with Raymond James.

Samit Hirawat: We'll take our next question from Dane Leone with Raymond James. Thank you for taking the questions and congratulations on the update. I'll keep it to two for me.

Hi, Thank you for taking my questions and congratulations on the update.

I'll keep it to two.

Two for me.

Firstly, just going back to the generic erosion debate heading into 2022.

David V. Elkins: Firstly, just going back to the generic erosion debate, heading into 2022, taking a different angle, obviously, post the acquisition of Celgene, that was accretive to your overall operating margin. The question from a lot of us that followed, Celgene historically, along with Bristol, has been, the belief was Revlimid drove a lot of that margin for Celgene. And with that going away, even with new brands ramping up, is there enough from the portfolio and steady state growth of, perhaps, Eloquist and Optivo to offset an impact operationally from EBITDA?

Taking a different angle, obviously post the acquisition of Celgene.

It was accretive to your overall operating margin.

<unk> from a lot of US are followed Celgene historically, along with Bristol has been.

The belief was revlimid drove a lot of that margin for celgene and with that going away, even with new brands ramping up is there enough from the portfolio and steady state growth of maybe <unk> and opdivo to offset and impact operationally from EBITDA.

Or will there need to be bridging like you said of additional.

David V. Elkins: Or will there need to be bridging, like you said, of additional cost efficiencies from the organization? So that's one, essentially getting to whether there could be another year or two of EBITDA growth from the existing portfolio. Secondly, a quick one from me.

Cost efficiencies from the organization, so that one essentially getting to whether there could be a last year or two.

EBITDA growth from the existing portfolio.

<unk> a quick one for me it's been brought up a lot why the team has not aggressively moved to start studies in more of a mild to moderate population proposed yet and ulcerative colitis. So any thoughts around the development plan there would be appreciated. Thank you.

David V. Elkins: It's been brought up a lot why the team has not aggressively moved to start studies in more of a mild to moderate population for zipposia and ulcerative colitis. So, any thoughts around the development plan there would be appreciated. Thank you. Thank you very much.

Thanks, very much so let me just start and ask David to make some comments there.

Giovanni Caforio: So let me just start and ask David to make some comments there. You know, I'll just reiterate what I said earlier, that from our perspective, the [inaudible] and the launch brands will actually enable the company to grow through that period. But David can give you a better perspective about the profitability of our business going forward and how we think. Thanks, Dane, for the question. You know, we've been very confident in our ability to maintain our operating margins in the low to mid 40% through 2025. And there are a couple things that are driving that.

I'll just reiterate what I said earlier that from our perspective.

As we think about the period of loss of exclusivity of Revlimid first of all we always said.

That our perspective about that but here in the U S that would be.

Slope that would be happening over time, we've made a comment in the past we were more conservative on that slope than consensus.

At the same time, we believe strongly in the fact that the growth of the line portfolio and the launch brands will actually enabled the company to go to grow.

Through that period, but David can give you a better perspective about the profitability of our business going forward and how we think about that.

<unk> for the question.

We feel very confident in our ability to maintain our operating margins.

In the low to mid 40% through 2025, and there's a couple of things driving that one as I discussed earlier, we're doing better on our synergies and strong execution against that.

David V. Elkins: One is, as I discussed earlier, we're doing better on our synergies and strong execution against that as we head into next year and the run rate after that. I'd say the other is that we've been very disciplined on the P&L side of things. And as you may note, from an MS&A perspective, we're very efficient and top-tier in our industry. And the other thing I would say is that we've been very disciplined from the standpoint of reallocating resources from those LOE brands to our launch, which gives us further confidence in that.

As we head into next year and the run rate after that I'd say the other is we've been very disciplined on the P&L side of things and as you may note.

From an M&A perspective, we're very efficient.

And top tier in our industry and.

The other thing I would say is that we've been very disciplined from the standpoint of reallocating resources from those low <unk> brands to our launch brands, which gives us further confidence in the last thing is if you think about the portfolio and the launches many of those products have strong margins as you.

David V. Elkins: And the last thing is, if you think about the portfolio and the launches, many of those products have strong margins, as you talked about on the inline with Updevo being a high-margin product, but also some of the other ones that are in the launch portfolio like Suposia as well as Red Blazell. Those products have nice margins as well.

<unk> talked about on the in line with.

Opdivo being a high margin product, but also some of the other ones that are in the launch portfolio like like suppose you as well as rent Brazil.

Those products are nice margins as well so that's what gives us confidence in our ability to keep those operating margins in that low to mid 40% as we progress.

David V. Elkins: So that's what gives us confidence in our ability to keep those operating margins in the low to mid 40s as we progress. And in terms of Zyphosia, we obviously have the indication for MS as well as UC, and the trials are ongoing in Crohn's disease. We currently do not have any plans for mild to moderate patients with UC, Christina. I think we have time for one last question. From Matt Phipps with William Blair.

And in terms of as opposed to we have obviously got the indication for MFS as well as you see and the drives in our ongoing Crohns disease. We currently do not have any plans in the mild to moderate.

Patients with UC at this time.

Thanks, So much Christine I think we have time for one last question.

We will take our last question.

Matt Phipps with William Blair.

Chris Boerner: Morning, thanks for including me. You mentioned that BECMA would be relatively flat going into the fourth quarter. But should we expect to be more or less flat until the vector supply issues resolve, which I think you said would occur in the second half of next year? And then can you just comment on whether the higher dose that was explored in the latest Lattice UC trial with Ducre is also being explored in Crohn's and SLE, or just maybe how there are different doses amongst those indications as well? Thank you, Chris.

Good morning, Thanks for including me, you mentioned that effect, but it would be relatively flat going into the fourth quarter, but should we expect you to be more or less flat until the vector supply issues resolved, which I think you said would occur in the second half of next year and then can you just comment on if the higher dose that was explored in the latest in the latest SEC trial with Duke.

It's also being explored in crowds and SLE or just maybe how those different dose most of those indications as well.

Thank you, Chris and then summit, so just quickly on the back.

Chris Boerner: So just quickly on Abecma, yeah, we've commented on how we anticipate Abecma sales growing in Q4. And we've also said that we are staying very focused on increasing vector supply as we get into the first half of next year. And so I don't have the ability to give you any additional information for next year. But obviously, we'll continue to update you in the future. Yeah, and as it relates to the doses, again, on ducrevasadinib and UC and CD, there are some similarities in the doses, but we have the option over here to amend and change the dose and dosing patterns here.

We've commented on how we anticipate backing ourselves growing in Q4, and we've also said that we are staying very focused on increasing vector supply as we get into the first half of next year and so I don't have the ability to give you any additional information for next year, but obviously, we will continue to update you on future calls.

Yeah, and as it relates to the doses again on the growth that <unk> been UC and CD.

There are some similarities in the doses, but we have optionality over here to amend and change the dose and dosing patterns here. So we'll continue to work with our DMC as well as our clinical trials teams are looking into the data.

Samit Hirawat: So we'll continue to work with our DMC as well as our clinical trial teams to see if there are any adjustments needed for either of these Thank you everyone. Thanks again for participating in the call. We had a great quarter with very, very strong performance. The launch portfolio continues to progress, and inline brands are growing strongly.

See if there are any adjustments needed for either of the two drops.

Thanks, everyone. Thanks again for participating in the call we had a great quarter with very very strong performance.

The loan portfolio continues to progress in line brands are growing strongly.

Tim Power: We look forward to the opportunity to continue to discuss the evolution of the pipeline and the future outlook of the company when we get together in the middle of November. Our investor team and the rest of his team will be available throughout the day to answer any other questions you have. Thanks and have a good day. For today's call, thank you for your participation; you may now disconnect.

I look forward to the opportunity to continue to discuss the evolution of the pipeline and the future outlook of the company when we get together in the middle of November for our Investor Day team and the rest of his team will be available throughout the day to answer any other questions you have thanks.

Hey.

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

[music].

Okay.

[music].

Okay.

Okay.