Q1 2022 Bristol-Myers Squibb Co Earnings Call

Operator: Good day and welcome to the Bristol Myers Squibb 2022 First 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.

Good day and welcome to the Bristol Myers escaped 2022 the first 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.

Tim Power: Thank you, Sergei. And good morning, everyone. Thanks for joining us this morning for our first quarter 2022 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call are Chris Boerner, our Chief Commercialization, and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can follow along with for Giovanni and David's remarks.

Thank you Sergey and good morning, everyone. Thanks for joining us this morning for our first quarter 2022 earnings call.

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

Also participating in today's call are Chris Boerner, our chief commercialization officer, and southern here, a lot, our chief Medical officer, and head of global drug development.

As you'll note we've posted slides to begin S. Dot com that you can follow along with where for Giovanni and David's remarks, but before we get started I will read our forward looking statements.

Tim Power: But before we get started, I'll read our forward-looking statement. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC 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. I specifically disclaim any obligation to update forward-looking statements, even if our estimates change.

During this call we will make statements about the company's future plans and prospects that constitute forward looking statements.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the company's SEC filings.

These forward looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date.

We specifically disclaim any obligation to update forward looking statements, even if our estimates change.

Tim Power: We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available on BMS.gov. That's all.

So also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available on the M. S Dot com until I'll hand over now to Giovanni.

Giovanni Caforio: Thank you, Tim. And good morning, everyone. Let's start with our first quarter performance on slide four. This is an important year for Bristol Myers Squibb, and I'm pleased to share that we've had a strong start to 2020. In fact, just yesterday, the FDA approved Mavacamtan or CamXyl. This is a first-in-class medicine for patients living with symptomatic obstructive HCV.

Thank you Tim and good morning, everyone, let's start with our first quarter performance on slide four.

This is an important year for Bristol Myers Squibb, and I'm pleased to share that we've had a strong start to 2022.

In fact, just yesterday, the FDA approved medlock Hampton or it comes Iris.

This is a first in class medicine for patients living with symptomatic obstructive HCM.

Giovanni Caforio: It's an important milestone for patients who, up until now, had no options to treat the underlying cause of death. I'm proud that we're giving hope to patients and improving their quality of life. It's also an important milestone for BMA.

It's an important milestone for patients who up until now had no options to treat the underlying cause of this disease.

I'm proud they were giving hope to patients and improving their quality of life.

It's also an important milestone for BMS we.

Giovanni Caforio: With U.S. approvals of Obdolag and Kansaios so far this year, we have significantly strengthened our new product portfolio. And we are on track to potentially launch three important new first-in-class medicines. Additionally, strong commercial execution in the quarter resulted in solid year-over-year growth from our in-line products and new product portfolio. During the quarter, we saw the first entries of REBLIMED generics in the U.S. and Europe. David will comment on our first quarter dynamics. But for the full year, U.S. entry expectations remain the same, while ex-U.S. erosion is expected to be faster than previously anticipated.

With U S approvals of Abdulla <unk>. So far this year, we have significantly strengthened our new product portfolio.

And we are on track to potentially launch three important new first in class medicines this year.

Additionally, strong commercial execution in the quarter resulted in solid year over year growth from our in line products and new product portfolio.

During the quarter, we saw the first entries of Revlimid generics in the U S and Europe .

David will comment on our first quarter dynamics.

For the full year U S entry expectations remain the same.

While ex U S erosion is expected to be faster than previously anticipated.

Giovanni Caforio: Overall, we grew revenue by 5% and delivered double-digit non-GAAP EPS growth compared to the same quarter last year. There is good momentum in our, and our performance in Q1 validates that we are well prepared for the renewal of our portfolio, with multiple catalysts across inline products and new product portfolio, to more than offset upcoming LOEs and drive growth through the day. Our very strong financial position gives us significant flexibility as we continue to prioritize business development while paying down debt and expanding shareholder distribution.

Overall, we grew revenue by 5% and delivered double digit non-GAAP EPS growth compared to the same quarter last year.

There is good momentum in our business and our performance in Q1 validates that we are well prepared for the renewal of our portfolio with multiple catalysts across inline products, a new product portfolio to more than offset upcoming eloise and drive growth through the decade.

Our very strong financial position gives us significant flexibility as we continue to prioritize business development, while paying down debt and expanding shareholder distributions.

Giovanni Caforio: Now let me turn to our scorecard on slide 5 and provide some context around the important achievements of the course. We are making good progress against our miles, which are central to delivering on our long-term strategy and growth as a, starting with the milestones we saw during the, Opdivo was approved in the U.S. in March as the first I.O. agent to treat early-stage, non-small cell lung cancer patients before surgery.

Now, let me turn to our scorecard on slide five and provide some context around the important achievements of the quarter.

We are making good progress against our milestones, which are central to delivering on our long term strategy.

Growth as a company.

Starting with the milestones we sold during the quarter.

<unk> was approved in the U S. In March as the first I O agent to treat early stage non small cell lung cancer patients before surgery.

Giovanni Caforio: This indication strengthens its profile in lung and provides additional tailwind for growth. While disappointed with the results of the BankPAC program, we are very pleased with the significant progress of our new product portfolio overall. Brianzi is now approved in Europe, our second CAR T cell therapy approved in the, As you know, we've been planning to bring three important new products to market. So far, two of those new products, Obdrolag and Kamzaios, received FDA approval. Many of our new products have significant expansion opportunities. For OBDUALAG, we recently initiated a pivotal study in colorectal cancer.

This indication strengthened its profile in lung and provides additional tailwind for growth.

While disappointed with the results of the bank back program. We are very pleased with the significant progress, although our new product portfolio overall.

<unk> is now approved in Europe , our second car T cell therapy approved in the EU.

As you know we've been planning to bring three important new products to market this year.

So far two of those new products umbrella and it comes Iris.

<unk> FDA approval.

Many of our new products have significant expansion opportunities.

Or abdulla <unk>, we recently initiated a pivotal study in colorectal cancer and for the club of Sydney, We delivered a successful phase II proof of concept result in lupus looking.

Giovanni Caforio: And for Ducravacidinib, we delivered a successful Phase II proof-of-concept result in Luisa's, Looking to the future, the breadth of milestones ahead is exciting. One that we're looking forward to is the Milvexian Phase 2 data in secondary stroke prevention. We have decades of expertise in cardiovascular. And we believe this could be a medicine that treats an even broader population of patients than current oral anticoagulants. We expect to get Phase II data in-house around the middle of the year.

Looking to the future the breath of milestones ahead is exciting.

One that we're looking forward to is the mill vaccine phase II data in secondary stroke prevention.

We have decades of expertise in cardiovascular disease.

And we believe this could be a medicine that treats and even broader population of patients than current oral anticoagulants.

We expect to get phase II data in house around the middle of the year and depending on the results. We plan to start phase III trials later this year.

Giovanni Caforio: And depending on the results, we plan to start Phase III trials later this year. Turning to our three new products on slide. As I mentioned, in March we received approval for the treatment of patients with unreceptable or metastatic, OBDUALAG is our first-in-class fixed-dose dual immunotherapy combination of nivolumab and a LAG-3 blocking agent antibody relator. A combination of Relatlimab and Evolumab demonstrated a clinically meaningful PFS-NOS, Ogdwalak marks the second approved I.O.

Giovanni Caforio: combination that we've delivered, and demonstrates our continued scientific leadership in IEA. While we are still in the early days, I can say that the Obdwalak launch is going very well. We believe this medicine has the opportunity to become a new standard of care for melanoma patients. In addition to melanoma, ovduolag has the potential for new indications, and we are exploring important opportunities in lung, liver, and corretto.

Turning to our three new products on slide six.

As I mentioned in March we received approval for <unk> for the treatment of patients with unresectable or metastatic melanoma.

<unk> is our first in class fixed dose dual immunotherapy combination often the volume up and the luxury blocking agent antibody relatively mum comb.

A combination of the lateral and if all of them up demonstrated a clinically meaningful PFS and OS benefit.

Although like marks the second approved Io combination that we've delivered and demonstrates our continued scientific leadership in I O.

While we are still in the early days I can say that the <unk> launch is going very well.

We believe this medicine that has the opportunity to become a new standard of care for melanoma patients.

In addition to melanoma Abdulla <unk> has the potential for new indications and we are exploring important opportunities in lung liver and colorectal cancers.

Giovanni Caforio: Turning now to our just-FDA-approved Mavacampton or Kansai. The benefit of CAMS-IOS for patients with symptomatic obstructive HCM were further reinforced with the exciting VALOR data presented at ACC this year. We're launching Camsaios in the U.S. and look forward to receiving EU approval and launching internationally. Future Indications, Finally, we continue to be excited about the opportunity for the Kravitz, As you know, we have an FDA PDUFA date in September for SORAN. We believe that psoriasis patients need better oral options, and this asset has demonstrated superior efficacy compared to the oral standard of care with a favorable safety and tolerability profile.

Turning now to our just FDA approved myopic Hampton what comes at Us.

The benefit of comes Iris for patients with symptomatic obstructive HCM with further reinforced with the exciting valor data presented at ACC. This month.

We're launching comes I was in the U S and look forward to receiving EU approval and launching internationally with future indications to come.

Finally, we continue to be excited about the opportunity for <unk>.

As you know we have an FDA <unk> date in September for psoriasis.

We believe that psoriasis patients need better oral options and these assets has demonstrated superior efficacy compared to the oral standard of care with a favorable safety and Tolerability profile.

Giovanni Caforio: During the first quarter, we also delivered a successful phase two proof-of-concept result in loop, positioning us to start Phase III studies later this year in a disease with a very high unmet need. Importantly, the lupus data continues to show the consistent and differentiated safety profile of a selective TIK2 inhibitor.

During the first quarter. We also delivered a successful phase II proof of concept result in Lucas.

Joining us to start phase III studies later this year in a disease with a very high unmet need.

Importantly, the lupus data continues to show the consistent and differentiated safety profile of a selective <unk> inhibitor.

Giovanni Caforio: We plan to share comprehensive data with the scientific community at an upcoming Congress this year. With our upcoming FDA PDUFA date in the third quarter, phase C trials already underway in psoriatic arthritis and a proof of concept achieved in lupus and additional phase two trials ongoing, including in IBD, our confidence in the potential of this program continues. Now, turning to slide 7.

We plan to share comprehensive data with the scientific community.

Coming Congress this year.

With our upcoming FDA <unk> date in the third quarter phase II trials already underway in psoriasis arthritis and <unk>.

Setback achieved in lupus.

And additional phase two trials ongoing including an IBD our confidence in the potential of this program continues to grow.

Now turning to slide seven.

David Elkins: Thanks to the hard work, dedication, and strong execution by our employees, I am confident in our ability to deliver on our, and more than offset key LOEs by continuing the growth of our inline product, with 8 to 10 billion in incrementals, and delivering $10 to $13 billion of revenue expected from our new product portfolio by 2021. Our strong clinical performance further de-risks our launch performance. And as a result, we have confidence in our ability to deliver the $25 billion-plus in non-risk-adjusted revenue in 2020. We have a strong foundation. And as the renewal of our portfolio gains further traction this year, I am confident in the potential of our company. Now, I'll turn it over to...

Thanks to the hard work dedication and strong execution by our employees I am confident in our ability to deliver on our strategy and more than offset key eloise by continuing the growth of our inline products with $8 billion to $10 billion in incremental sales and delivering 10 to 13.

<unk> billion of revenue expected from our new product portfolio by 2025.

Our strong clinical performance further de risks our launch portfolio and as a result, we have confidence in our ability to deliver the 25 billion plus in non risk adjusted revenue in 2029.

We have a strong foundation in place.

And as the renewal of our portfolio gains further traction this year I am confident in the potential of our company now I'll turn it over to David Thank.

David Elkins: Thank you, Giovanni, and welcome again to our first quarter earnings call. I'm pleased to turn to slide nine to discuss our top-line performance. Unless otherwise stated, I will discuss sales performance on an underlying basis, which excludes the impact of foreign exchange translation. Total company revenues in the quarter exceeded $11.6 billion, growing 7% year-over-year.

Thank you Giovanni and welcome again to our first quarter earnings call I'm pleased to turn to slide nine to discuss our topline performance unless otherwise stated I will discuss sales performance on an underlying basis, which excludes the impact of foreign exchange translation.

Total company revenues in the quarter exceeded 11 $6 billion growing 7% year over year. This was driven by strong double digits sales of our in line and new product portfolio, partially offset by a recent eloise.

David Elkins: This was driven by strong double-digit sales of our in-line and new product portfolio, partially offset by our recent LOE. Let's take a closer look at our New Product Portfolio performance on slide 10. In the first quarter, the New Product Portfolio contributed $350 million in revenue, more than doubling revenue versus prior year.

Let's take a closer look at our new product portfolio performance on slide 10 in the first quarter, the new product portfolio contributed $350 million in revenue more than doubling revenue versus prior year with a combination of factors, including the usual year end buying patterns impacting sequential performance remain confident in the growth potential of the new product portfolio.

David Elkins: The combination of factors, including the usual year-end buying patterns impacting sequential performance, remain confident in the growth potential of the new product portfolio. The first-in-class approvals of OptiLag and yesterday's FDA approval of Comzius further strengthen our confidence in the new product portfolio. We also look forward to our upcoming PDUFA Day for Dukravacit Nib in September, which would deliver another first-in-class medicine for patients with the opportunity to deliver more than $4 billion in non-risk-adjusted revenue in 2029.

The first in class approvals are up the lag in Yesterdays FDA approval comes iOS further strengthens our confidence in the new product portfolio. We also look forward to our upcoming Paducah date for decrepit sitting up in September which would deliver another first in class medicine for patients with the opportunity to deliver more than $4 billion and non risk adjusted.

Revenue in 2029, these initial approval or just the beginning as many of these new medicines have significant expansion opportunities into additional indications.

David Elkins: These initial approvals are just the beginning, as many of these new medicines have significant expansion opportunities into additional indications. Now let's look at our expanded and more diversified business by therapeutic area, turning to our solid tumor performance on slide 11. Updevo and Uravoid continue their growth trajectory, growing double digits versus prior year.

Now, let's look at our expanded and more diversified business by therapeutic area turning to our solid tumor performance on slide 11.

Opdivo and year avoid continue their growth trajectory growing double digits versus prior year. This was driven by continued demand for our newly launched indications and our core indications in the U S. Opdivo grew double digit versus prior year driven by demand in first line lung renal and gastric cancer as well as adjuvant in Suffolk.

David Elkins: This is driven by continued demand for our newly launched indications and our core indications. In the U.S., Optiva grew double-digit versus prior year, driven by demand in first-line lung, renal, and gastric cancer, as well as adjuvant esophageal and bladder, Outside the U.S., first quarter year-over-year revenues increased double-digit. This strong growth was primarily driven by expanded access in emerging markets, as well as demand for new indications in developed markets as we continue to secure reimbursements. Looking forward, we expect continued growth of Updevo from our new and expanding indication, With the launch of OptiLag in mid-March, we are pleased to be the only company with three approved I.O. agents.

Oh and bladder cancers.

Outside the U S first quarter year over year revenues increased double digit.

This strong growth was primarily driven by expanded access in emerging markets as well as demand for new indications in developed markets as we continue to secure reimbursement.

Looking forward, we expect continued growth of opdivo from our new and expanding indications.

With the launch of up to lag in mid March we were pleased to be the only company with three approved Io agents, while early days in the launch we generate approximately $6 million in sales half of which was demand and the other half stocking. We are encouraged by the initial feedback, suggesting the potential for up to like to be a new standard of care for patients with <unk>.

David Elkins: While early days in the launch, we generated approximately $6 million in sales, half of which was demand and the other half stocking. We are encouraged by the initial feedback suggesting the potential for OptiLag to be a new standard of care for patients with metastatic melanoma, and I look forward to providing more updates as the year progresses. Now let's move to our growing cardiovascular portfolio on slide 12. I'll start with Eliquis, which continues to grow globally with revenues up 14% year over year. In the U.S., sales increased 12% versus prior year, driven primarily by total prescription growth of 10%. Internationally, sales were strong, up 17% versus a year ago.

Static melanoma, and I look forward to providing more updates as the year progresses.

Now, let's move to our growing cardiovascular portfolio on slide 12, I'll start with eloquence, which continues to grow globally with revenues up 14% year over year in the U S sales increased 12% versus prior year, driven primarily by total prescription growth of 10%.

Internationally sales were strong up 17% versus a year ago.

David Elkins: This strong double-digit growth was primarily driven by increased share across key markets and the brand continues to be the number one OAC in multiple countries. Turning to our expanded portfolio, I'm really excited about the approval of Mavicamptan, now known as Kymzias, for patients with symptomatic obstructive hypertrophic cardiomyopathy, or OHCM. We plan to leverage BMS's existing CV leadership, building our strong expertise and relationship, focused initially at top HCM centers. Our field teams are excited to bring this product to patients in the U.S., and Chris can provide more details on our go-to-market strategy in the Q&A session. Now let's turn our attention over to a few of our hematology products on slide 13, starting with Revlimax. Sales in the quarter were nearly $2.8 billion.

This strong double digit growth was primarily driven by increased share across key markets and the brand continues to be the number one O act in multiple countries.

Turning to our expanded portfolio I'm really excited about the approval magic Camden now known as conveyors for patients with symptomatic obstructive hypertrophic cardiomyopathy or O H C. M. We plan to leverage BMS as existing CB leadership building, our strong expertise and relationship focused initially a top <unk>.

Centers, our field teams are excited to bring this product to patients in the U S and Chris can provide more details on our go to market strategy and the Q&A session.

David Elkins: Revenues were primarily impacted by generic entry. During Q1, we saw generics enter the U.S. later than expected entry, and so far at a modest pace. As mentioned last quarter, we expect variability quarter to quarter due to the uncertainty of how generic players will enter the market, though there is no change to our outlook for the U.S. Revlimed this year and beyond, we expect favorability we saw in Q1 to reverse in Q2.

Now, let's turn our attention over to a few of our hematology products on slide 13, starting with Revlimid sales in the quarter with nearly $2 8 billion.

Revenues were primarily impacted by generic entry during Q1, we saw generics entered the U S. Later than expected entry and so far at a modest pace as mentioned last quarter, we expect variability quarter to quarter due to uncertainty of how generic players will enter the market.

So there is no change to our outlook for the U S.

Revlimid this year and beyond we expect favorability we saw in Q1 to reverse in Q2 and internationally generics launch broadly across Europe in mid February and erosion has been faster than expected as a result, we now expect full year global sales to be approximately nine to $9 5 billion.

David Elkins: And internationally, generics launched broadly across Europe in mid-February, and erosion has been faster than expected. As a result, we now expect full-year global sales to be approximately $9 to $9.5 billion. Based upon U.S. phasing and ex-U.S. dynamics, we expect second quarter global revenues to be approximately $2 billion. POMLIS global revenues grew 9% versus prior year.

Used upon U S phasing in ex U S dynamics, we expect second quarter global revenues to be approximately $2 billion.

David Elkins: Global revenues continue to be driven by volume and market share gains. Patients Move to Earlier Lines of Treatment and Extending Duration of Treatment, Moving to Rebozel, which generated revenues of $156 million in the quarter, sales were up 41% versus prior year, primarily driven by continued demand in ESA refractory MDS patients. In the U.S. to date, we have robust on-label share in RS-positive patients. We're seeing encouraging trends in the reduction of time and the switch from ESA failures, also supported by NCCN guidelines.

Harmless global revenues grew 9% versus prior year global revenues continue to be driven by volume and market share gains as patients move to earlier lines of treatment and extending duration of treatment now.

Now moving to read those out which generated revenues of $156 million in the quarter sales were up 41% versus prior year, primarily driven by continued demand and Esa refractory.

S patients.

In the U S to date, we have robust on label share in Rs positive patients. We are seeing encouraging trends in the reduction of time in the switch from ESA failures, which is also supported by NCC and guidelines. We have also made progress in physicians up trading.

David Elkins: We have also made progress in physicians up-trading a patient's dose to ensure sustained duration and benefit. Our focus remains on patient identification and dose titration for optimal outcomes. And outside the U.S., rublisol continues to grow with increased share in both MDS and beta thalassemia-associated anemia. We have now launched in six countries outside the U.S. and expect to launch in more markets in 2022. Moving to cell therapy launches, Abecma and Brianzi. Abecma generated revenues of $67 million in the first quarter.

<unk> dose to ensure sustained duration and benefit our focus remains on patient identification and dose titration for optimal outcomes and outside the U S. Rub itself continues to grow with increased share in both Mds and beta thalassemia associated anemia.

We have now launched in six countries outside the U S and expect to launch in more markets in 2022.

David Elkins: As expected, sales were largely similar to the fourth quarter of 2021, as demand continues to be robust, and we work hard to expand capacity. We are on track to expand capacity in the middle of this year to be able to help more patients with highly refractory multiple myeloma. As it relates to Brionzi, sales in the quarter were $44 million.

Moving to cell therapy launches of Beckman Brianti Beckman generated revenues of $67 million in the first quarter as expected sales were largely similar to the fourth quarter of 2021 as demand continues to be robust and we work hard to expand capacity. We are on track to expand capacity in the middle of this year to be able to help more patients.

With highly refractory multiple myeloma.

As it relates to <unk> sales in the quarter were $44 million sales were driven primarily by demand in the U S where physicians continue to recognize beyond these best in class profile. We're very pleased with the recent EU approval for Beyonce and third line plus large b cell lymphoma, and look forward to launching in select markets in 2022.

David Elkins: Sales are driven primarily by demand in the U.S. so our physicians continue to recognize Bryanzi's best-in-class profile. We are very pleased with the recent EU approval for Bryanzi in third-line plus large B-cell lymphoma and look forward to launching in select markets in 2022. Additionally, we are preparing for the U.S. launch of Brionzi and second-line large B-cell lymphoma in June and are ramping up capacity in order to treat more patients. Moving to our Immunology Product Summary on slide 14, our Rencia sales grew 6% versus prior year due to expanded U.S. sales driven by increased market share in the U.S. As it relates to Ziposia, global sales in the quarter were $36 million, doubling sales compared to prior year.

Additionally, we are preparing for the U S launch of <unk> in second line large b cell lymphoma in June and are ramping up capacity in order to treat more patients.

Moving to our immunology products summary on slide 14, our Rensselaer sales grew 6% versus prior year due to expanded U S sales driven by increased market share in the U S. As it relates to suppose your global sales in the quarter were $36 million doubling sales compared to prior year sequentially in the U S. We saw encouraging demand growth.

David Elkins: Sequentially in the U.S., we saw encouraging demand growth that was offset primarily by buying patterns from prior quarter and higher gross-to-net impacts related to patient access and ulcerative colitis. We are pleased with the awareness and perception of ZipoZN-UC and are encouraged by the strong increase in new patient starts. We continue to work further expanding volume while strengthening access and reimbursement and expect to have increased contribution from UC in the second half of this year and expanding in 2023. Internationally, Suposia continues to secure reimbursement in other markets for MS, as well as obtain additional reimbursement for the newly approved UC indication last quarter.

That was offset primarily by buying patterns from prior quarter and higher gross to net impacts related to patient access in ulcerative colitis, where.

We're pleased that the awareness and perception of supposedly in UC and are encouraged by the strong increase in new patient starts we continue to work further expanding volume, while strengthening access and reimbursement.

<unk> increased contribution from you see in the second half of this year and expanding in 2023.

Internationally as opposed to you continued to secure reimbursement in other markets for MFS as well as obtaining additional reimbursement for the newly approved UC indication last quarter.

David Elkins: Lastly, as we continue to broaden our immunology portfolio, launch plans are already underway to prepare for ducrevacitin's upcoming PDUFA date in September. Now let's turn to our first quarter P&L on slide 15. As noted recently, we changed the presentation of our non-GAAP results. Along with other pharmaceutical companies, we no longer exclude significant research and development charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights.

Lastly, as we continue to broaden our immunology portfolio launch plans are already underway to prepare for <unk> citizens upcoming <unk> date in September .

Now, let's turn to our first quarter P&L on slide 15.

As noted recently, we changed the presentation of our non-GAAP results along with other pharmaceutical companies, we no longer exclude significant research and development charges or other income, resulting from upfront our contingent milestone payments in connection with asset acquisitions or licensing of third party intellectual property rights.

David Elkins: These charges have been included in our GAAP results and there is no impact to the economics of our business. Going forward, we will now include these previously specified charges in both GAAP and non-GAAP results as a new line item called Acquired In-Process Research and Development, as well as capture the previously specified income in our OI&E line item. In the quarter, operating expenses, including acquired in-process research and development, increased versus prior year, primarily due to increased MS&A driven by differences in timing of spend in the prior year, as well as investments in our new product portfolio.

These charges have been included in our GAAP results and there is no impact to the economics of our business going forward. We will now include these previously specified charges in both GAAP and non-GAAP results is a new line item called acquired in process research and development as well as capture the previously specified income and our Oi.

The line item.

In the quarter operating expenses, excluding acquired in process research and development increased versus prior year, primarily due to increased M. S. N a driven by differences in timing of spend in the prior year as well investments in our new product portfolio.

David Elkins: Net charges of $280 million consisting of acquired and process R&D charges offset by licensing income are primarily driven by upfront milestone payments associated with the Amatics and Dragonfly licensing agreement. The first quarter effective tax rate was impacted by earnings nexus.

Net charges of $280 million, consisting of acquired in process R&D charges offset by licensing income primarily driven by upfront milestone payments associated with the <unk> and dragonfly licensing agreements.

First quarter effective tax rate was impacted by earnings mix.

David Elkins: Even with this new financial presentation, and the Tencent impact from the inclusion of acquired in process R&D and previously specified income. Our strong performance in the quarter allowed us to grow non-GAAP EPS 13% versus last year. Excluding this, the new presentation chain of non-GAAP EPS would have grown 18%.

Even with this new financial presentation, and the 10 cent impact from the inclusion of acquired in process R&D and previously specified income our strong performance in the quarter allowed us to grow non-GAAP EPS, 13% versus last year. Excluding this the new presentation chain of non-GAAP EPS would have grown 18.

Percent.

David Elkins: Now moving to the balance sheet and capital allocation on slide 16. Cash flow generation for the company remains strong. Cash flow from operations in the quarter was approximately $3.8 billion.

Now moving to the balance sheet and capital allocation on slide 16 cash flow generation for the company remained strong.

From operations in the quarter was approximately $3 $8 billion. We ended the quarter in a strong liquidity position with approximately $15 billion in cash and marketable securities.

David Elkins: We ended the quarter in a strong liquidity position with approximately $15 billion in cash and marketable security. Our capital allocation priorities remain unchanged, BD continues to be a top priority, and we remain committed to continued debt reduction and returning capital to shareholders. And in the quarter, we executed a $5 billion accelerated share repurchase program. Approximately 65 million shares, or 85% of the 5 billion aggregate repurchase price, were delivered to the company in the quarter.

Our capital allocation priorities remain unchanged BD continues to be a top priority and we remain committed to continued debt reduction and returning capital to shareholders.

And in the quarter, we executed a $5 billion accelerated share repurchase program, approximately 65 million shares or 85% of the 5 billion aggregate repurchase price were delivered to the company in the quarter. The ASO ASR will settle over the next couple of quarters, and we remain opportunistic about future share repurchases.

David Elkins: The ASR will settle over the next couple quarters, and we remain opportunistic about future share repurchase. Now turning to our 2022 non-GAAP guidance on slide seven. As you know, we guide based upon prevailing exchange rates at the time we report a result. We're updating our top line guidance to be in line to prior year, primarily due to movements in foreign exchange, reflecting the spot rate of the dollar today, and faster erosion of Revlimid outside the U.S.

David Elkins: Recent LOE product guidance is also being changed to reflect the updated Revimed Outlook in the range of $9 to $9.5 billion. Though FX headwinds impact our entire portfolio, the outlook for inline products and a new product portfolio remains unchanged. This reflects the strong performance and confidence in our future growth drivers. We now expect total operating expenses, excluding in-process R&D, to decline in the low single digits versus prior year, driven primarily by cost discipline and the impact of foreign exchange.

Now turning to our 2022 non-GAAP guidance on slide 17.

As you know we guide based upon prevailing exchange rates at the time, we report our results we're updating our topline guidance could be in line to prior year, primarily due to movements in foreign exchange, reflecting the spot rate of the dollar today and fast erosion of Revlimid outside the U S.

Recent low product guidance is also being changed to reflect the updated revenue outlook in the range of nine to $9 5 billion.

FX headwinds impact our entire portfolio of the outlook for in line products and the new product portfolio remains unchanged. This reflects the strong performance and confidence in our future growth drivers.

We now expect total operating expenses, excluding in process R&D to decline in the low single digits versus prior year, driven primarily by cost discipline and the impact of foreign exchange.

David Elkins: Including the change in financial presentation that we've adopted for non-GAAP earnings, there is no change to our outlook for non-GAAP EPS for the year. With the impact of certain acquired and processed R&D and licensing income that are now included in non-GAAP EPS, our new range is $7.44 to $7.75. This change is driven by the previously announced $0.10 impact from the actuals in the first quarter. An additional $0.11 relates to the buyout of future royalty obligations for Maverick Hampton that occurred in April.

Excluding the change in financial presentation that we've adopted for non-GAAP earnings. There is no change to our outlook for non-GAAP EPS for the year with the impact of certain acquired in process R&D and licensing income that are now included in non-GAAP EPS, our new range of $7 44 to.

The $7 74.

This change is driven by the previously announced <unk> <unk> impact from the actuals in the first quarter, an additional 11 related to the buyout of future royalty obligations for mavic Hampton that occurred in April .

David Elkins: Before we move on to Q&A, I want to thank our colleagues around the world for continuing to deliver strong commercial, clinical, and financial results, and I'm really excited for what lies ahead. I'll now turn it back over to Tim and Giovanni for Q&A. Thanks, David.

Before we move on to Q&A I want to thank our colleagues around the world for continuing to deliver strong commercial clinical and financial results and I'm really excited for what lies ahead I will now turn it back over to Tim and Giovanni for Q&A.

Operator: Sergey, could we go to our first question, please? Sure, our first question comes from Chris Schott from J.P. Morgan. Please go ahead.

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

Chris Schott: Great. Thanks so much for the questions. Just two for me.

Sure. Our last question comes from Chris Schott from Jpmorgan. Please go ahead.

Giovanni Caforio: First, can you maybe talk about ChemZios, if I'm pronouncing that right, and the echo monitoring requirement there? It seems like it's a fairly kind of long program. I'm just wondering how you see that impacting any uptake the drug could have. And the second question for me was on Melvexian and just the read across from the Bayer Factor 11a data we saw last month. I guess a specific question would be, if you just talk about the attractiveness of AFib as a category for the Factor 11a's, and is that a focus for Bristol? Or is your focus more in markets where there currently isn't, I guess, Factor 10a usage? So just any color there would be appreciated.

Great. Thanks, so much for the questions just two for me.

First could you maybe talk about Kim <unk> from pronouncing that right and the echo monitoring requirement. There. It seems like it's a fairly kind of long program I'm. Just wondering how you see that impacting any uptake the drug could have.

And the second question from me was on <unk> and just the read across from the buyer factor 11, a data. We saw last month I guess specific question would be can you just talk about the attractiveness of Afib.

The category for the factor 11 days in it.

Is that a focus for Bristol or is your focus more in markets, where theyre currently isn't I guess factor 10, eight usage. So should any color there would be appreciated. Thank you.

Chris Boerner: Thank you. Thank you, Chris. Good morning. I'll ask Chris to answer your question on Kamzaios, and then Samit will comment on Milvexian. Hi, Chris.

Thank you Chris good morning.

I'll ask Chris to answer your question on <unk> and then some it will comment on <unk> Hi, Chris. Thanks for the question. Since this is the first question on <unk>. So let me just say at the outset that we're incredibly excited to be launching <unk>. This is an important new medicine for obstructive HCM patients and for those of you who were at ACC. You know there is palpable excitement.

Chris Boerner: Thanks for the question. Since this is the first question on Kamzaios, let me just say at the outset that we're incredibly excited to be launching Kamzaios. This is an important new medicine for obstructive HCM patients.

Chris Boerner: And for those of you who are at ACC, you know, there's palpable excitement and anticipation of this drug. So this is a great opportunity for patients. Let me say a couple of things on just the REMS in general, and then I'll get to your question on the echo monitoring.

And in anticipation of this drug. So this is a great opportunity for for patients.

Can you say a couple of things on just the Rems in general and then I'll get to your question on the Echo monitoring we've been working with <unk> team and the FDA on the design of this rems and with customers on how we would execute against it for a number of months. We view obviously the rems is important because it ensures that patients are able to be treated safely that they.

Chris Boerner: We've been working with Samit's team and the FDA on the design of this REMS and with customers on how we would execute against it for a number of months. We view, obviously, the REMS as important because it ensures that patients are able to be treated safely, that they get on the right dose, and that they're able to ultimately get the full benefit for Kamzaios. There are two key components as you think about this REMS. There's a titration period, which is all about monitoring patients to ensure they get the right dose. This is largely akin conceptually to how cardiologists manage hypertension.

On the right dose and that Theyre able to ultimately get the full benefit for <unk>. There are two key components. As you think about this rems theres, a titration period, which is all about monitoring patients to ensure they get the right dose. This is largely a kin conceptually how cardiologists manage hypertension and then the second component.

Chris Boerner: And then the second component is ensuring eligibility of drug-given background medications. As we look across both of these two key components together, we see the requirements for the REMS as manageable, generally fitting, as I referenced earlier, to the treatment approach for cardiac patients. And we don't see them as a barrier to adoption.

One is ensuring eligibility of drug given background medications as we look across both of these two key components together, we see the requirements for the Rems is manageable generally fitting as I referenced earlier to the treatment approach for cardiac patients and we don't see them as a barrier to adoption now with respect.

Chris Boerner: Now, with respect to the echo monitoring period specifically, we obviously consulted customers as we were working through the design of the REMS, and they don't see it as a concern for a couple of reasons. First, the requirements of this monitoring period are relatively minimal. You have to get an LVEF and an LVOT reading. That can be done with your local physician.

The Echo monitoring period, specifically, we obviously consulted customers as we were working through the design of the Rins and they don't see it as a concern for a couple of reasons.

First their requirements of this monitoring period are relatively minimal you have to get an lv ethane in L. V O T reading that can be done with your local physician. So for those patients who are being treated in centers of excellence. They can go back to their cardiologist local cardiologist office to fulfill those requirements.

Chris Boerner: So for those patients who are being treated in Centers of Excellence, they can go back to their local cardiologist's office to fulfill those requirements. Second, you have to remember patients would be coming back a couple of times a year anyway for ECHOs and a number of patients would be coming back much more frequently for symptom management. So physician visits every three months is not seen as particularly burdensome. And the last thing I would highlight is a very important point, which is that patients are going to be highly motivated to work their way through this period. As we saw with the Explorer study, patients are highly motivated to stay on drugs. They feel better on CAMS IOs.

And you have to remember patients would be coming back a couple of times a years anyway for echos and a number of patients would be coming back much more frequently for symptom management. So physician visits every three months is not seen as particularly burdensome and the last thing I would highlight is a very important point, which is that patients are going to be highly motivated.

To work their way through this period as we saw with the explorer study patients are highly motivated to stay on drug they feel better on <unk> and so we think theres going to be strong motivation on their part to work through these requirements. So net net.

Chris Boerner: And so we think there's going to be strong motivation on their part to work through these requirements. So net-net, this is something we'll be obviously educating customers on, but we don't see this as a barrier. And Chris, thanks for that.

This is something we'll be obviously educating customers on but we don't see this as a barrier to us.

And Chris Thanks for that Chris from GPM for your question on <unk> I think first of all we are truly excited about that medicine as well as <unk>.

Samit Hirawat: And Chris from JPM, for your question on Melvixian, I think, first of all, we are truly excited about that medicine as well, as we look forward to getting the data in-house in the middle of the year. The read-through from the Bayer presentation, I would say, is that it further strengthens our confidence in the mechanism of action as well as provides a further proof of concept that inhibiting factor 11a is a safe way to provide further anticoagulation or antithrombotic therapies for patients who really need, As it comes to what indications we'll be pursuing, we'll continue to work with our partners Janssen to really define those once the data are in-house, and we can look at the data, the dose, the ways of administering the drug, and all in all, we'll be able to share that with you once we're ready with the data and the results. Thanks a lot.

We look forward to getting the data in house in the middle of the year.

The read through from the buyer presentation I would say is that it further strengthens our confidence in the mechanism of action as well as provides a further proof of concept that inhibiting factor eliminate is a safe way to provide further anticoagulation or anti thrombotic therapies for patients who really need it as it comes to what indications we will be pursuing will come.

To work with our partners Janssen to really define those once the data are in house and we can look at the data that does the the ways of administering the drug and all in all we'll be able to share that with you. Once we are ready with the data and the read throughs.

Thank you.

Senate Sergey can we go to the next question. Please.

Operator: Sergey, could we go to the next question, please? Sure, Chris Shibutani, Goldman Sachs, please go ahead. Great. Thank you very much. Good morning.

Sure Chris Sheppard <unk> Goldman Sachs. Please go ahead.

Chris Shibutani: Congratulations on the approval. On Kansaios as well, perhaps can you talk about two issues, one relating to access and the other in terms of timelines for which you feel that the physicians are going to get more comfortable with dosing? Perhaps can you update us on your expectations for access timing relative to this approval and with the early phases of the rollout? And again, timing on when you're going to be educating physicians and expecting them to get more comfortable with the regimen and the REM. Thank you. Thank you, Chris. Chris?

Great. Thank you very much good morning, congratulations on the approval comes iOS as well, perhaps can you talk about two issues one relating to access and the other in terms of timelines for which you feel that the physicians are going to get more comfortable with dosing, perhaps can you update us on your expectations for access timing relative to.

With this approval and with the early phases of the rollout and again on timing on when youre going to be educating physicians that expecting them to get more comfortable with.

With the regimen and the ramp.

Thank you. Thank you Chris Chris sure. So two very good questions. So let me start with access in general we anticipate the majority of these patients are going to have very good access for this therapy remember about half of the patients who are obstructive HCM are covered by commercial and Medicaid and.

Chris Boerner: Sure. So, two very good questions. So, let me start with access. In general, we anticipate the majority of these ZIOS patients are going to have very good access for this therapy. Remember, about half of the patients who are obstructive HCM are covered by commercial and Medicaid, and we think access in this patient population is going to be particularly good, and we expect, initially, a disproportionate share of our use is going to come from the patient population.

We think access in this patient population is going to be.

Particularly good and we expect initially a disproportionate share of our use is going to come from this patient population now remember like virtually all specialty medicines Kim's iOS is not going to be on formulary day. One we will plan to cover these patients on bridge programs for the roughly four to six weeks that are going to be required to work through the exception.

Chris Boerner: Now, remember, like virtually all specialty medicines, CAMS-IOS is not going to be on formulary day one. We will plan to cover these patients on bridge programs for the roughly four to six weeks that are going to be required to work through the exceptions process, but we've built strong patient support programs to assist these patients during this time, and we expect minimal barriers for these patients during this initial period. And then, of course, once CAMS-IOS is on formulary, we would expect access to be much more straightforward.

Process, but we've built strong patient support programs to assist these patients during this time and we expect minimal barriers for these patients. During this initial period and then of course <unk> is on formulary, we would expect access to be much more straightforward now for Medicare patients.

Chris Boerner: Now, for Medicare patients, we expect that share is going to grow over time as any affordability challenges there get resolved. Initially, the opportunity will be mainly in the low-income subsidy patients, but then the broader population use will expand as additional support becomes available to address any affordability issues there. With respect to your second question on timelines for dosing education, we actually think that's going to be relatively rapid. A few things to keep in mind.

We expect that share is going to grow over time as any affordability challenges there get resolved initially the opportunity will be mainly in the low income subsidy patients, but then the broader population use will expand as additional.

Support becomes available to address any affordability issues there with respect to your second question on timelines for dosing Education, We act.

We think thats going to be relatively rapid a few things to keep in mind number one as we work through this label I referenced that we were working with customers on how we would execute against the rems. So many of the customers, particularly in centers of excellence, which will be the primary focus at launch are already roughly familiar with the dosing requirements.

Chris Boerner: Number one is we worked through this label. I referenced that we were working with customers on how we would execute against the REMS, so many of the customers, particularly in Centers of Excellence, which will be the primary focus at launch, are already roughly familiar with the dosing requirements here, and obviously, the initial focus of our commercial efforts are going to be in these Centers of Excellence, so we think the understanding of the dosing requirements and the REMS more generally are going to be very good at launch there.

<unk> here and obviously the initial focus of our commercial efforts are going to be in these centers of excellence. So we think the understanding of the dosing requirements in the Rems more generally are going to be very good at launch there and then we're going to be targeting a much broader audience. In fact, the majority of potential obstructive HCM patients with our launch.

Chris Boerner: And then we're going to be targeting a much broader audience, in fact, the majority of potential obstructive HCM patients with our launch efforts. We're staffed to do that, and those education efforts are underway beginning today. Chris, Sergey, could we go to the next one, please? Sure. Geoff Meacham from Bank of America.

Efforts, we're staffed to do that and those educations efforts are underway beginning today.

Thanks, Chris Sergey could we go to the next one please.

Operator: Please go ahead. Hey, guys. Good morning.

Sure Jeff Meacham from Bank of America. Please go ahead.

Geoff Meacham: Thanks for the question. I just had a couple on the new product launches. So first on Brianzi, I just wanted to get kind of an update of where you guys, what you guys think drives a real inflection, if you had any update as well, on the manufacturing, that would be helpful. And then on Zapposia, can you just talk a little bit about the drag on access, just timing for, you know, for formulary editions, etc. Just kind of wondering the drivers of an inflection for that for that brand as well.

Hey, guys. Good morning. Thanks for the question I just had a couple on the new product.

Launches so first on brands.

Just wanted to get kind of an update of where you guys. What you guys think drives a real inflection if you had any update as well on the manufacturing that would be helpful. And then on supposedly a could you just talk a little bit about the drag on on access just timing for for formulary additions et cetera.

Just kind of wondering the drivers of of an inflection for that for that brand as well. Thank you.

Giovanni Caforio: Thank you. Thank you, Jeff. Chris?

Thank you, Jeff Chris sure. So let me talk about <unk> first then I'll touch on them on as opposed yeah. So brianti, we're happy with the continued performance that we saw in the quarter. We were up obviously sequentially, we're seeing within our existing indications continued.

Chris Boerner: Sure. So let me talk about Brionzi first, then I'll touch on Zyposia. So Brionzi, we're happy with the continued performance that we saw in the quarter. We were up, obviously, sequentially.

Chris Boerner: We're seeing within our existing education continued strong interest from physicians in using the product. Patient enrollments from activated accounts were up nicely in the quarter. We saw a nice increase in apherese patients, and that translated into growth in Brionzi's overall class share, which is now roughly 20 to 25 percent. Particularly important from my perspective is that Brionzi continues to be seen as the best in class asset here. And so that gives us confidence not only in our existing indication, but obviously we're very much looking forward to a label expansion into the second line setting for this asset, which continues to be on track. And Samit can speak to that in the second half of the year.

Strong interest from physicians in using the product patient enrollments from activated accounts were up nicely in the quarter. We saw a nice increase in <unk> patients and that translated.

Into growth in <unk> overall class share, which is now roughly 20% to 25%, particularly important from my perspective is that <unk> continues to be seen as the best in class asset here and so that gives us confidence not only in our existing indication, but obviously, we're very much looking forward to a law.

<unk> expansion into the second line setting for this asset which continues to be on track and some that can speak to that in the second half of the year with respect to manufacturing.

Chris Boerner: With respect to manufacturing, as we've said previously, obviously that's a big focus for us. We have consistently said that our focus is on expanding that capacity by the middle of the year to be ready for that second line launch. And those efforts continue to be on track. As far as Zeposia, again, I think we are happy with the continued progress that we've made with Zeposia. As David referenced, we had a few dynamics in the quarter with respect to gross to net and inventory.

As we've said previously obviously, that's a big focus for us.

We have consistently.

<unk> consistently said that where our focus is on expanding that capacity by the middle of the year to be ready for that second line launch.

And those efforts continue to be on track as far as opposed to a again I think we are happy with the continued progress that we've made with suppose he as David referenced we had a few dynamics in the quarter was with respect to gross to nets.

And inventory that said as we look at that.

Chris Boerner: That said, as we look at that product, particularly in UC, which is obviously important for the long-term growth of the product, there are two things that are going to be critically important for the success of the product. First, we've got to, as you referenced, improve access, and second, we've got to drive volume. And since both of those things co-travel, maybe I'll just give you a quick update on both.

That product, particularly in U C, which is.

Obviously important for the long term growth of the product. There are two things that are going to be critically important for the success of the product first we've got to as you referenced improve access and second we've got to drive volume and since both of those things co travel maybe I'll just give you a quick update on both with respect to access we have very broad formulary.

Chris Boerner: With respect to access, we have very broad formulary access today. And in fact, we've seen the quality of that access improve this year relative to last year. But as we expected, the majority of patients for Zeposia in UC still have multiple step edits. And so we've got to continue to improve access for these patients. And the way we will do that is by driving volume.

Access today and in fact, we've seen the quality of that access improved this year relative to last year, but as we expected the majority of patients for as opposed to you and you see still have multiple step edits and so we've got to continue to improve access for these patients and the way we will do that is by driving volume in on that.

Chris Boerner: And on that front, we made good progress in the quarter. Patient starts were up about 30% in Q1 relative to Q4. We continue to expand our user base nicely. And importantly, we continue to drive intent to prescribe, all of which we think set us up for continued volume growth. Now, the majority of those patients, when they come on therapy, are going to initially be triaged to our bridge program. So what we've got to do this year is, first, we've got to convert those patients to commercial drug where possible. For patients who have better access, we need to convert them over from our bridge program onto commercial drug. And there's a big focus this year to do that.

We made good progress in the quarter patient starts were up about 30% in Q1 relative to Q4, we continue to expand our user base night nicely and importantly, we continue to drive intent to prescribe all of which we think set us up for continued volume growth now the majority of those patients when they come on therapy.

We're going to initially be triage to our bridge program. So we've got to do this year is first we got to convert those patients to commercial drug where possible.

For patients who have better access we need to convert them over from our bridge program onto commercial drug and Theres a big focus this year to do that and then second obviously, we've got to continue to drive new patient starts.

Chris Boerner: And the second, obviously, we've got to continue to drive new patient starts. So as I look at the quarter, I think we've made good headway. We've got more work to do. But as we begin to achieve success, particularly in moving those patients from bridge to commercial, you'll see greater volume of sales coming from UC and that will set us up for continued success later this year and into 2020. Chris, Sergey, could we go to the next one please? Seamus Fernandez, Guggenheim, please go ahead. Great, thanks so much for the questions. The first one really is on milvexian.

So as I look at the quarter I think we've made good headway, we've got more work to do but as we begin to achieve success, particularly in moving those patients from bridge to commercial Youll see greater volume of sales coming from UC and that will set us up for continued success later this year and into 'twenty three.

Chris.

Go to the next one please.

Seamus Fernandez Guggenheim. Please go ahead.

Great. Thanks, so much for the question so.

Seamus Fernandez: I wanted to drill into your comments earlier on the call with regard to the opportunity in SSP and your knowledge there. Feedback that we have gotten from thought leaders and experts in the space view this as a bit of a riskier indication, more in the context of the patients that get recruited and the interactions that can occur between colpidogrel and aspirin. That perhaps could confuse a little bit of the data as it relates to factor XI.

The first one really is on <unk>.

I wanted to drill into.

Your comments earlier on the call with regard to the opportunity and SSP and your knowledge there feedback that we have got from thought leaders and experts in the space.

We view this as a bit of a riskier indication.

More in the context of the patients that get recruited Andy.

Interaction that can occur between Clopidogrel and aspirin.

Samit Hirawat: So, I wanted to just get a better understanding of how you guys are controlling for that. There are genetic factors that impact colpidogrel, bleeding risk, things like that, as well as the efficacy of colpidogrel. So, just wanted to get a sense of how you are managing for that, whether you're stratifying for it or perhaps looking at that after the fact. And then the second question on Mavacanthin. Obviously, I think the price may be surprised to the upside a little bit at $90,000 annually.

That perhaps could confuse a little bit of the data as it relates to factor 11. So wanted to just get a better understanding of how you guys are controlling for that there are genetic factors that impact clopidogrel bleeding risk things like that.

As well as the efficacy of competitor growth. So just wanted to get a sense of how you are managing for that whether you stratify for it or perhaps looking at looking.

Looking at that on a.

After the fact and then the second question on Mavic Hampton, Obviously, I think the price may be surprised to the upside a little bit at $90000 annually.

Giovanni Caforio: That's quite a widespread between that result and the ICER evaluation of less than $15,000 a year. You know, can you just comment on that differential and how you hope to get beyond that with additional clinical studies? Thanks, guys. Thank you, thank you, Seamus. So let me just make a comment at the beginning. You know, we've been very clear with respect to the ICER assessment of Mavakampton with the fact we didn't think it was scientifically accurate and not based on solid data and methodology.

That that's quite a widespread between that result, and the ice or evaluation of less than $15000 a year.

Obviously.

Can you just comment on that differential and how you hope to get.

Beyond that with additional clinical studies thanks, guys.

Chris Boerner: So Chris will give you his perspective about the Mavakampton value and price. Before that, though, Samit will answer your question on Milvexian in essence. Thank you Giovanni and thanks Seamus for your question. On Milvexian, as you know, the SSP trial is ongoing. It's more than 2,000 patients that have been enrolled in the study and will have a readout in the middle of the year, as I said earlier. We have the background therapy of clopidogrel as well as aspirin. Clopidogrel, which is given in the first month and ASA continues for the next month.

Thank you. Thank you Seamus So let me just make a comment at the beginning.

We've been very clear.

With respect to the ice or assessment of monarch Hampton.

The fact that we didn't think it was scientifically accurate and not based on.

<unk> data and methodologies. So Chris will give you his perspective about the multicore <unk> in value and price before that though.

It will.

Without a question on the Unbilled exiting SSP.

Samit Hirawat: Up to three, with that data we'll be getting all the PK data as well as all of the safety data and we'll be able to then analyze if there are any interactions having said that we've done quite a number of DDI studies and we do not see drug-drug interactions as issues, And, of course, the overall safety that we will get from this study, combined with the data from the TKR study that we've already done, will then define how we proceed further. So, since the data are almost around the corner, let's wait for that and not speculate on how the application will be in the SSP study. And certainly, when the data are available and then presented at medical conferences in the future, we can have a further dialogue on that. Thank you. And Chris?

Thank you Giovanni and thanks Seamus for your question on on the vaccine as you know that SSP trial is ongoing it's more than 2000 patients that would be that have been enrolled in the study and we'll have a readout in the middle of the year as I.

Said earlier, we have the background therapy of corporate growth.

That's what I was aspirin competitor grow which is given in the first month and assay continues for the next.

Up to three months with that data, we will be getting all of the PK data as well as all of the safety data and we will be able to then analyze if there are any interactions having said that we've done quite a number of DDI studies and we do not see drug drug interactions as issues and of course, the overall safety that we will get from this study combined.

With the data from the <unk> study that we've already done will then define how we proceed further so since the data are almost around the corner, let's wait for that and not speculate on how the application will be in the SSP study and certainly when the data are available and then presented at medical conferences in the future. We can have a further.

Dialog on that thank you and Chris Thanks, Seamus I think Giovanni address the question on ISR. So as it relates to the specific price for <unk>, we priced this product very much consistently with how we price products generally which is looking at a variety of factors and notably the value that the drug brings to patients and the health care system with.

Chris Boerner: Thanks, Seamus. I think Giovanni addressed the question on ICER. So, as it relates to the specific price for Kamzaios, we price this product very much consistently with how we price products generally, which is looking at a variety of factors, and notably, the value that the drug brings to patients in the healthcare system with a strong focus on ensuring that we are providing rapid and sustained access for patients.

Strong focus on ensuring that we are providing rapid and sustained access for patients remember with <unk>. This is the first therapy that effectively targets the source of obstructive HCM. So there really arent any clinically comparable therapies here you've got <unk>.

Operator: Remember, with Kamzaios, this is the first therapy that effectively targets the source of obstructive HCM. So, there really aren't any clinically comparable therapies here. You've got largely ineffective, nonspecific products like beta and calcium channel blockers that are relatively old and inexpensive. And then you've got more effective but highly invasive procedures like myectomy and septal ablation. These procedures alone can be upwards of $100,000 to $150,000.

Evan Seigerman: And then you've got ancillary costs associated with those. And remember, they don't cure the disease, so you've got ongoing, multi-year costs associated with these products as well. So, it's a fairly broad range of prices. Where we net it out here, we think, is a price that, as I mentioned before, reflects the value of the product. We don't see any incremental concerns with respect to access. And as I referenced in the previous question, we have a robust suite of programs and resources that are in the market to help address any patients or caregivers to support access for this product. Let's go to the next question, sir. Sure. Evan Seigerman from BMO, please go ahead.

Largely ineffective nonspecific products like beta and counsel calcium channel blockers that are relatively old and an expensive and then you've got more effective.

Highly invasive procedures like <unk> and.

Septal ablation. These these procedures alone can be upwards of a 100 to $150000 and then you've got ancillary costs associated with those and remember they don't cure the disease. So you've got ongoing multi year costs associated with these products as well so it's a fairly broad range of prices.

Where we netted out here, we think theres a price that as I mentioned before reflects the value of the product we don't see any incremental concerns with respect to access and as I referenced in the previous question. We have a robust suite of programs and resources that are in the market to help address any patients or caregivers to support access for this product.

Okay, Let's go to the next question Sergey.

Sure.

Hey, Evan <unk> from BMO. Please go ahead.

David Elkins: Hi guys, thank you so much for taking my questions and congrats on the approval last night. So I just wanted to touch on Revlimid. I know, David, you had mentioned some color on the call in your prepared remarks, but aside from FX, can you characterize any other potential downside risks to the guidance over the remainder of the year? I'm just trying to get a sense of kind of the erosion curve, OUS, and what we should be thinking about.

Hi, guys. Thank you so much for taking my questions and congrats on the approval last night. So I just wanted to touch on Revlimid I know David you had mentioned some color on the call in your prepared remarks, but aside from FX can you characterize any other potential downside risk to the guidance over the remainder of the year, just trying to get a sense of kind of the erosion curve.

And what we should be thinking about and now that we're into the quarter can you really characterize what youre seeing and kind of maybe give us some more color there and just on one housekeeping item on that royalty obligation you bought back or May have a kimpton any impact we should be thinking about in our models. Thanks. So much.

David Elkins: And now that we're into the quarter, can you really characterize what you're seeing, OUS, and kind of maybe give us some more color there? And just on one housekeeping item, on that royalty obligation you brought back for Mavikampton, any impact we should be thinking about in our models? Thanks so much.

David Elkins: Yeah, thanks, Evan, for the question. And on Revlimid, you really need to think about it in the context of the two markets, the US and OUS. And as I said, in my prepared remarks for the US, the generic entry was later than we'd anticipated, and the erosion has been modest.

Yes, Thanks, Evan for the question and on Revlimid, you really need to think about it in the context of the two markets. The U S and O U S and as I said in my prepared remarks for the U S. Generic entry was later than we had anticipated and the erosion has been modest so.

David Elkins: So, you know, and as a result of that, we think that will come out in the second quarter. And that's why I provided guidance on the second quarter for Revlimid overall of $2 billion in Q2. As you think about the full year, outside the U.S., we have multiple generics enter in Europe in mid-February. And that erosion has been faster than we anticipated.

And as a result of that we think that will come out in the second quarter and that's why we provided guidance on the second quarter for Revlimid overall of $2 billion in Q2.

As you think about the full year outside the U S. We have multiple generics enter in Europe in mid February and that erosion has been faster than we anticipated and based upon that erosion that we're seeing that's why we changed the full year guidance on revlimid between nine and $9 5 billion.

David Elkins: And based upon that erosion that we're seeing, that's why we changed the full year guidance on Revlimid between $9 and $9.5 billion. As you think about, you know, longer-term Revlimid going forward, you may recall that we provided a guidance of about $2 to $2.5 billion per year over the next couple of years. And as we head into next year, since the erosion a little faster this year, we'll probably be at the lower end of that range of around $2 billion for next year.

As you think about.

Longer term revlimid going forward you may recall that we provided a guidance of about two to $2 $5 billion per year over the next couple of years and as we head into next year since the erosional faster. This year will probably be at the lower end of that range of around $2 billion for next year. So that's on Revlimid and now the Kimpton there was a minor.

David Elkins: So that's on Revlimid. In Mavikemptin, there was a minor royalty that we were able to, you know, retire that obligation. And, you know, it'll be a slight improvement to our gross margins, but we don't guide gross margins for our products overall. All right, it's a low single-digit royalty obligation that we're able to expire. Thanks. Can we go to the next one, please, Sergei? Andrew Baum, CD.

Royalty that we were able to.

You know retired that obligation and.

It'll be a slight improvement to our gross margins, but we don't guide gross margins for our products overall.

Alright, so low single digit royalty obligation that we're able to.

Expire.

Thanks can we go to the next one Sergey.

Andrew Baum Citi. Please go ahead.

Operator: Please go ahead. Thank you. A couple of questions, please. Assuming axiomatic SSP reads out positive, I'm curious as to which clinical settings you'd actively avoid with Nalvexian, given it only inhibits one of the pathways, the intrinsic pathways. DOACs have failed in ESIF. They've failed in the chemical heart valves. I'm just looking for some guidance not where you want to go, but where you would be disinclined to go.

Thank you a couple of questions. Please assuming axiomatic SSP reads out positive I'm curious since two which clinical testings you'd actively avoid with no vaccine given that <unk> inhibits wanted the pathway intrinsic pathways DOCSIS failed in ECS that failed in mechanical heart valves.

I'm just looking for some guidance not why you're going to go but where you would be disinclined to guy and then second given the accumulating long term follow up on the <unk> system.

Andrew Baum: And then second, given the accumulating long-term follow-up on Dekrabasif's NERP as the indications expand, I wonder whether you'd care to comment on any imbalances for zoster or thrombosis in that collected data that I'm sure you've shared with the agency. Thank you, Andrew. Let me ask Samit to answer both of your questions. Thank you, Andrew, and I like the new flavor of the question on the indications for Melvixian asking the same question the different way, but I think my answer will remain the same for you, that we are not disclosing at this time what indications we are going to pursue or exclude.

As the indications expand I wonder whether you can comment on any inbounds as well.

Or thrombosis.

And that collected data that I'm sure you have shared with the agency.

Thank you Andrea let me.

Ask Simon to answer both of your questions. Thank you, Andrew and I like the new flavor of the question on the indications for Nellix in asking the same question a different way, but I think the answer will remain the same for you.

We are not disclosing at this time, what indications we are going to pursue or exclude we will have to make those decisions. Once we have the dose as well as our conversations with our partners and of course in conversations with regulatory agencies in terms of how we will conduct the studies what control arms will be used et cetera, So certainly would be happy to.

Andrew Baum: We will have to make those decisions once we have the dose, as well as our conversations with our partners, and, of course, in conversations with regulatory agencies in terms of how we will conduct the studies, what control arms will be used, et cetera. So certainly would be happy to have that dialogue once we are there with the data, as well as… On Dukravacetinib, you're absolutely right. We are continuing to be very confident in the profile of the medicine. We have the data, of course, from POETIC-1, POETIC-2 with long-term follow-ups now. We've conducted studies in psoriasis in China and Japan as well, which continue to support the overall profile.

That dialogue once we are there with the data as well as the decisions on duca. That's at Nab, you're absolutely right. We are continuing to be very confident in the profile of the medicine. We have the data of course from point, a one pointed to with long term follow ups now.

Conducted.

Studies in psoriasis in China, and Japan, as well, which continue to support the overall profile additional data of course from sciatic arthritis Phase II studies.

Samit Hirawat: Additional data, of course, from psoriatic arthritis phase 2 studies, SLE study that we've talked about as well, all continue to support the overall safety profile that we have seen in terms of the very specific inhibition of the TIK2 pathway without an impact on the JAK pathway. So the differentiation continues, and those are the data that we have provided from the psoriasis perspective to the agency, and looking forward to that launch in moderate to severe psoriasis in September. I'm at Sergei, can we go to the next one? Steve Scala, Colin, please go ahead.

<unk> study that we've talked about as well all continued to support the overall safety profile that we have seen in terms of the.

The very specific inhibition of the two pathway without an impact on the JAK pathway. So the differentiation continues and those are the data that we have provided from the services perspective to the agencies and looking forward to that launch in moderate to moderately severe psoriasis in September of this year.

Thanks, Sergey can we go to the next one.

Steve Scala Cowen. Please go ahead.

Operator: Thank you very much. I'd like to follow up on the Revlimid trajectory. It looks like the second half Revlimid revenue is expected to be about $4.2 to $4.7 billion. That implies a flat-to-up performance versus the second quarter. Can you discuss why it will be flat-to-up in H2 if pressure has intensified in both the U.S. and O.U.S.

Thank you very much I'd like to follow up on the Revlimid trajectory. It looks like the second half Revlimid revenue is expected to expect it to be about $4 two to $4 7 billion that imply say flat to up performance versus the second quarter can you discuss why it will be up in.

Flat to up in H, two if pressure has intensified in both the U S and O U S.

Steve Scala: ? And that's the first question. Yeah. The second question is, and I apologize for splitting hairs, but Milvexian data was expected in the first half. Now it's mid-year. That is a modest change, but has there been some sort of delay, maybe because of events? This isn't necessarily meant directed at Bristol, but it seems in this industry, mid-year is always the third quarter, and the third quarter is always September, so any color would be appreciated.

So that's the first question. The second question is and I apologize for splitting hairs, but no vaccine data was expected in the first half now its mid year.

That is a modest change but has there been some sort of delay maybe because of events.

This isn't necessarily meant.

Directed at Bristol, but it seems in this industry mid year is always the third quarter in the third quarter is always September so any color would be appreciated. Thank you.

Giovanni Caforio: Thank you. Thank you, Steve. Let me answer the second question, and then I'll ask David to answer your question on Revlimid. There is no change to the timelines for Melvexian.

Thank you Steve Let me answer the second question and then I'll ask David to answer your question on Revlimid. There is no change.

To the timelines for <unk> and so the study is on is on track and we look forward to updating you as soon as.

David Elkins: So the study is on track, and we look forward to updating you as soon as... Adelaide, Thimothy Power, Michael Schott, Michael Schott, David? Yeah. And Steve, thanks for the question on Revlimed. The thing that's important to remember, in the U.S., we only have one generic entry in the first half of the year. And then we have multiple generics that we're entering in the second half of the year. So that's why the phasing is, you know, from quarter to quarter.

The data is in house.

David.

David Elkins: And it can shift, as I was saying, between, because the generic entry will be in the September timeframe. So depending on how quickly that comes into the market will impact the phasing of the product quarter to quarter. But you will see more generics in the U.S. in the second half of the year. David, Sergey, can we go to the next question? Luisa Hector, Berenber, please go ahead.

Steve Thanks for the question on Revlimid.

The thing Thats important to remember in the U S. We only have one generic entry in the first half of the year.

And then we have multiple generics that we're entering in the second half of the year. So that's why the phasing is.

From quarter to quarter and it can shift as I was saying between because the generic entry will be in the September timeframe. So depending on how quickly that comes into the market will impact the phasing of the product quarter to quarter, but you will see more generics in the U S. In the second half of the year.

David Sergey can we go to the next question. Please.

So Lisa Hector Bahrenburg. Please go ahead.

Operator: Thank you very much for taking my questions. I want to ask you whether we can compare and contrast, The Ziposia Ramp with the potential ramp of Ducravacitinib, do you anticipate a similar sort of Challenge I guess in terms of access and volume as you, bring that product to market and really it's a question about how we should moderate our ramp our launch ramp for do you have a city, And on M&A, you know, your comments still, you know, consistent commentary.

Thank you very much for taking my questions I wanted to check.

Ask you, whether we can compare and contrast.

How does the ramp with the potential ramp of <unk>.

So tonight.

Do you anticipate.

So this challenge I guess in terms of accession volume I E.

Bring that product to market.

Question about how we should moderate our ramp.

Hum.

For Cabozantinib.

On the M&A.

Comment still.

Just your commentary, but given some of the changes to the valuation of the target.

Operator: But given some of the changes to valuations of some of the targets, I just wondered whether any of the dialogue is also shifting? Are you finding more companies approaching you? Is there more dialogue around collaborations on early stage pipeline? Just any shift in the dialogue?

I just wondered whether any of the dialogue is also shifting are you finding more companies approaching do you is there more dialogue around collaboration on any stage pipeline just any shift in the dialogue. Thank you.

Luisa Hector: Thank you. Thank you very much. Let me just answer the second question on M&A and then Chris will answer your question on Ducravel. Let me just reiterate that our focus on M&A has always been there. It's the central pillar of our capital allocation strategy.

Okay. Thank you very much let me just ask answer the first and the second question on M&A and then Chris will answer your question on <unk>. So.

So let me just reiterate that our focus on M&A.

As always been there.

Giovanni Caforio: It's a really important part of our innovation strategy. We've actually had a number of deals that we've executed in the last few months, which really confirms our very proactive approach to business development and more broadly. And as a result of that, that will continue to guide us in the future. With respect to your question about whether we are seeing any change, our experience is that whenever there is some type of realignment in market values, it always takes a little bit of time for those values to really be the values the boards of biotech companies look at in terms of their valuations. Having said that, of course, values were extremely high.

Central pillar of our capital allocation strategies are important part of our innovation strategy. We've actually had a number of deals that we've executed in the last few months, which really confirms a very proactive approach.

<unk> business development.

And more broadly and as a result of that that will continue to guide us in the future with respect to your question about whether we are seeing any change on our experience is that whenever there is a.

Some type of re alignment in market values. It always takes a little bit of time for those values.

To to really.

B devalues the boards.

Biotech companies look at in terms of.

Giovanni Caforio: They've somewhat realigned. And then I'll conclude by saying that every company is a bit of a different story and you have to really look at it one at a time. But we are confident in the ability to continue to bring new innovation into the company through a combination of business development strategies that go from partnership and collaboration in licensing and potential acquisitions. Chris?

Their valuations, having said that of course.

Of course.

Values were extremely high.

Somewhat re aligned.

And then.

I'll conclude by saying that every company is a bit of a different story and you have to really look at it one at that time, but we are confident in the ability to continue to bring new innovation into the into the company through a combination of business development strategies that go from Boston and reshape.

Collaboration and licensing of potential acquisitions, Chris Yeah. So thanks Louise for the question just a couple of things I would say at a high level. There are various there are some important similarities between UC and and psoriasis volume is going to be important to gain access over.

Chris Boerner: Yeah, so thanks, Louisa, for the question. Just a couple of things. I would say at a high level there are some important similarities between UC and Psoriasis.

Chris Boerner: Volume is going to be important to gain access over time. This is a market that, while it is less competitively intense than what you see in UC, particularly in the oral setting, it is a market that has been historically heavily managed. Now, there are some important differences as well.

Time.

This is a market that while it is less competitively intense than what you see and you see particularly in the oral setting.

It is a market that has been historically heavily managed now there are some important differences as well whilst psoriasis is heavily managed we have seen a number of national players have payers have moved from highly restricted access to more open formulary management over the last few years. That's good for new entrants. We also know that many.

Chris Boerner: While Psoriasis is heavily managed, we have seen a number of national payers have moved from highly restricted access to more open formulary management over the last few years. That's good for new entrants. We also know that many patients are going to be covered on plans that have open access when we launch. Again, that's an important opportunity for a new entrant like Ducravacitinib. But for the remainder of covered lives, it's going to be important, as we've been discussing with Zaposia, to build volume over time so that we can work with payers to gain more of a favorable access position. So there are some similarities between the two and then a couple of important differences as well.

<unk> are going to be covered on plans that have open access when we launch again, that's an important.

Opportunity for a new entrant like do crab are sitting at.

But for the remainder of covered lives. It is going to be important as we've been discussing was supposed to build volume over time. So that we can work with payers to gain more and more of a favorable access position. So there are some similarities between the two and then a couple of important differences as well.

Okay can we go to the next one.

Operator: Okay, can we go to the next one? Tim Anderson, Walth Research, please go ahead. Hi, thanks for taking our question. This is Adam on behalf of Tim. So first on TIC-2, can you talk about the commercial potential in psoriasis under two different scenarios, the first being if you get a black box warning, and the second is without that warning? If you do get a black box warning, would it be safe to assume that sales in psoriasis could be something like half of what they would be if you had a clean label?

Tim Anderson Wolfe Research. Please go ahead.

Hi, Thanks for taking our question. This is Adam on the outlets to EM.

So first on <unk> can you talk about the commercial potential.

In psoriasis under two different scenarios. The first Dean you get a black box warning and the second is without that warning. If you do get a black box warning would it be safe to assume that sales in psoriasis.

Something like half of what they would be if you had a clean label and then secondly, just real quick on my three.

Tim Anderson: And then secondly, just real quick on lag three, when will we get the next round of important data that will inform on success outside of melanoma, not just phase three results, but also from earlier trials ongoing? Thanks, Adam. This is Giovanni.

When will we get the next round of important data that will inform us success outside of melanoma, not just phase III results, but also estimate earlier trials ongoing.

Yeah.

Giovanni Caforio: So on take two, let me just start by saying we are increasingly confident in the potential of that program as I mentioned earlier with PDUFA data in September for psoriasis, ongoing phase three study in psoriatic arthritis, and then of course, the SLE proof of concept readout earlier this year, together with ongoing phase two studies in a number of other indications, including, including IBD. So the prospects for the program continue to strengthen as we go forward.

Thanks, Adam This is Giovanni so take two let me just start by saying.

We are increasingly confident in the potential of that program is.

As I mentioned earlier with <unk>.

<unk> data in September for psoriasis ongoing phase III.

Studying writing arthritis, and then of course the SLE.

Proof of concept readout earlier this year together with ongoing.

Phase II studies in a number of other indications including <unk>.

Giovanni Caforio: We've, we've answered that question on regulatory outcomes, specifically with respect to the label a number of times, but let me ask Chris, to give you his perspective again, and, and, and then Samit will comment on the lag, Sure. Thanks, Adam, for the question. So first, I'm not going to speculate on the black box scenario.

Including IBD so.

The prospects for the program continue to strengthen as we go forward.

We've answered that question.

On regulatory outcomes, specifically with respect to the labor a number of times, but let me ask Chris to give you his perspective again and and and then some it will comment on the lag three program sure. Thanks, Adam for the question.

Chris Boerner: As we've said consistently, we're going to continue to operate under the perspective of the most likely scenario and the scenario that we believe is most supported by the data, which is that the Kravacitinib has a unique mechanism of action consistent with all of the preclinical and clinical data that we have. And so our focus from a commercial standpoint, while we of course scenario plan various versions of a label, that's going to be the operating plan that we go as the most likely case.

So first I am not going to speculate on.

The black box scenario as we've said consistently we're going to continue to operate under the <unk>.

Prospective of the most likely scenario in the scenario that we believe is most supported by the data which is that the crab is sitting up has a unique mechanism of action consistent with all of the preclinical and clinical data that we have.

And so our focus from a commercial standpoint, while we of course scenario plan various versions of a label that's going to be the operating plan that we go as the most likely case and so we're still very much focused on leveraging the data from the two phase III studies that we have that clearly show clinical data that is superior both from.

Chris Boerner: And so we're still very much focused on leveraging the data from the two phase three studies that we have that clearly show clinical data that is superior both from an efficacy standpoint and safety superiority to Hotezla, which is the only branded oral in the market today. And given that efficacy, we believe we have a very strong case for establishing Ducravacitinib as the branded oral of choice here. Launch preparations are well underway. We have a great team already in the field from a medical standpoint. The home office team has been staffed and is up and running.

And efficacy standpoint, and safety superiority to <unk>, which is the only branded oral in the market today and.

And given that efficacy.

We believe we have a very strong case for establishing <unk> as the branded oral of choice here launch preparations are well underway, we have a great team already in the field from a medical standpoint, the home office team has been stopped and is up and running.

Chris Boerner: We're in the process of hiring the sales force. So our going position continues to be consistent with Ducravacitinib as a unique mechanism of action, and we think we have the clinical profile and the team in place to deliver on establishing this product as the branded oral of choice. Thanks, Chris.

The process of hiring the sales force. So are going position continues to be consistent with <unk> has a unique mechanism of action and we think we have the clinical profile and the team in place too.

To deliver on establishing this product as the branded oral of choice Sunday.

Samit Hirawat: And Adam, just on the OpDuo lag, because lag three is obviously being developed as a fixed dose combination with Nivolumab. We have several studies ongoing, not only as BMS sponsored trials, but also through investigator initiated trials. And through those investigator initiated trials, there will be continued evolution of the data that will be coming through, even including from this ASCO itself. So you will see the data continuing to come out at various conferences through either our trials or through the ISRs that are being conducted.

Chris and Adam just on the <unk> because <unk> is.

Obviously being developed as a fixed dose combination with <unk>, we have several studies ongoing not only as a BMS sponsored trials, but also through investigator initiated trials and through those investigator initiated trials.

The continued evolution of the data that will be coming through.

Even including from this <unk> itself. So you will see the data continuing to come out at various conferences through either our trials are through the ISR that are being conducted and of course, then the phase III and start.

Start to read out over the coming years.

Samit Hirawat: And of course, then the phase threes, and we'll start to read out over the coming days. Sergei, can we go to the next one please? Terence Flynn, Morgan Stanley, please go ahead. Hi, thanks for squeezing me in. Maybe two for me.

Sergey can we go to the next one please.

Terence Clean Morgan Stanley . Please go ahead.

Operator: A follow up on up Dualag. I know it's still early in the launch, but just wondering what types of patients you're seeing receive the drug. I know your initial focus was going to be on the PD-1 monotherapy setting, but is that pretty consistent? Or are you seeing broader use? And then in terms of a BECMA, what percentage of demand are you able to supply now? And can you help quantify how much additional supply will come on later this year? Thank, Thanks, Terence. Chris?

Hi.

For squeezing me in maybe two for me a follow up on up do a lag I know it's still early in the launch, but just wondering what types of patients you're seeing receive the drug I know your initial focus was going to be on the PD, one monotherapy setting, but is that pretty consistent or are you seeing broader use.

Then in terms of <unk>.

What what percentage of demand are you able to supply now and can you help quantify how much additional supply will come on later this year. Thank you.

Terence Flynn: Sure, let me start with OptiLag. So we're very pleased, as David noted, with the, not only the approval, but the reaction from positions has been very positive. Based on the early read that we have, and again, it's only a few weeks of data, the, what we're seeing in the marketplace is entirely aligned with our expectations. So number one, the profile is very well received, given the 2x improvement in PFS, the strong trend toward OS, similar safety relative to PD-1 monotherapy.

Thanks, Chris.

Sure, let me start with op do lag.

So we're very pleased as David noted with the not only the approval, but the reaction from physicians has been very positive.

Based on the early read that we have and again, it's only a few weeks of data the what we're seeing in the marketplace is entirely aligned with our expectations. So number one the profile is very well received given the two X improvement in PFS, the strong trend toward OS similar safety relative to PD, one mono therapy.

Terence Flynn: So the excitement that we've seen around the profile is as we hoped and expected for this asset. Second, what positions are playing back to us is they see using this product in the segment initially of the market that we had anticipated. Remember, first-line metastatic melanoma is a market that is essentially divided into thirds. A third of patients are getting dual IO therapy, a third of patients are getting PD-1 monotherapy, and a third are getting targeted therapies, notably BRAF mutants.

So the excitement that we've seen around the profile is as we hoped and expected for this asset.

<unk>.

What positions are playing back to us as they see using this product in the segment initially of the market that we had anticipated remember first line metastatic melanoma is a market that is essentially divided into thirds a third of patients are getting a dual I O therapy, a third of patients are getting PD, one mono therapy and a third are getting tar.

Terence Flynn: And so our initial focus had been on the PD-1 monotherapy segment, and that's where physicians have begun to use the product. Now, it's possible that over time that could expand into other segments, but keep in mind that Opdivo Urovoi has a very strong presence there, just given the long-term survival benefit.

<unk> therapies, notably BRAF mutants.

And so.

Our initial focus had been on the PD, one monotherapy segment, and that's where physicians have begun to use the product now it's possible that over time that could expand into other segments, but keep in mind that opdivo <unk> has a very strong presence there just given the long term survival benefit.

Chris Boerner: So we anticipate, and what we're hearing right now, is that the initial use is going to be in the PD-1 monotherapy, as expected. With respect to Abecma, what I can tell you is that the demand continues to be very strong. We have utilized every manufacturing slot that we have for Abecma over the quarter.

We anticipate and what we're hearing right now is that the initial use is going to be in the PD. One monotherapy is expected with respect to <unk>. What I can tell you is that the demand continues to be very strong. We had utilized every manufacturing slot that we have for beckman over the quarter.

Chris Boerner: Our focus continues to be on building demand to the middle of the year in anticipation of continued strong demand for this asset over time. And remember, this is a space in which we've had a competitive agent enter, and so we've still seen very strong demand for Abecma, which is also in line with expectations. So while I won't give specific guidance as to exactly what that ramp will look like, what I can tell you is our focus continues to be on making sure that we make more slots available for Abecma.

Our focus continues to be on building.

Building demand.

To the middle of the year in anticipation of continued strong demand for this asset over time.

And remember this is a space in which we've had a competitive agent to enter and so we've still seen very strong demand for our Vega, which is also in line with expectations. So while I won't give specific guidance as to exactly what that ramp will look like what I can tell you is our focus continues to be on making sure that we make more slots available for beckman where in la.

Chris Boerner: We're in line with our expectations on being able to be in a much better position by the middle of the year. Okay, can we go to the next one, please? Dean Leonie, Raymond Gems, please go ahead.

Line with our expectations on being able to be in a much better position by the middle of the year.

Okay can we go to the next one please.

Leoni Raymond James Please go ahead.

Operator: Thank you for taking the questions. Two questions from me, please. Mavicampton. You know, the premise for the acquisition by Accardia was obviously not just Mavicampton, but was largely predicated on Mavicampton.

Okay. Thank you for taking the questions.

From these days.

Okay.

Neither campaign.

The premise for the acquisition like Cardiome is obviously not just months I can't say, but largely predicated on that.

Dean Leonie: Thank you all so much for joining us today and I hope that we've given you an opportunity to develop not just an obstructive HTM but potentially non-obstructive and HEPPATH as well. The questions we've been getting a lot since the approval last night and the review of the label, no real surprises in terms of the hand-holding needed to get a patient on drug and then monitor the patient while they're on drug, given the pharmacodynamic and PK properties of Mavicamptin.

The opportunity to develop not just in obstructive HCM, but potentially non obstructive and half path as well.

We've been getting a lot since the approval last night and their review of the label no real surprises in terms of the handholding needed to get a patient on drug and then monitor the patient while they're on drug given the pharmacodynamic and PK properties of Maverick Hampton, but really the discussion comes down to Uh huh.

Dean Leonie: But really the discussion comes down to how an EMBARQ, which is your HEPPATH study that I think we'll read out maybe next year, can the dosage and treatment algorithm be modified to make the drug and its properties more accommodative to a preserved detection fraction patient population or a non-obstructive patient population? And should we expect to have maybe lower doses be viewed as potentially effective in those populations that might resolve some of the hand-holding needed for the drug?

How in and embarked which is youre half past study that I think will readout, maybe next year.

Can the dosage and treatment algorithm can be modified to make the drug and its properties more accommodative to a preserved.

Preserved ejection fraction patient population, Oregon truck.

Dave.

Population and should we expect.

Back to have maybe lower doses the viewed as potentially effective in those populations that might resolve.

Some of the handholding needed for the drug and then the second question back to back Matt.

Samit Hirawat: And then the second question is actually from Beckman. We will have a readout, I think, of Atopic Derm coming off the Phase 2 study that should be fairly informative. Could you just give us your expectations of what you need to see there to feel confident moving forward in Atopic Derm with that drug?

We will have a readout I think atopic derm kind of not the phase two study that should be fairly informative could you just give us your expectations of what you need to see there and feel confident moving forward in atopic derm the backdrop. Thank you.

Samit Hirawat: Thank you. Okay, thank you. Thank you, Dane. Let me ask Samit to answer both of your questions. Yeah, thanks, Dave. The line was cutting off, but I think I got the gist of it. So when we think about Maverick-Canton, you very correctly said that now that the drug is approved in obstructive hypertrophic cardiomyopathy, our intent, of course, is based on the data from the Maverick Phase II study and the long-term follow-up from there.

Okay. Thank you. Thank you Dan let me ask summit to Johnson both of your questions. Thanks, Dave the language cutting off but I think I got the gist of it. So when we think about <unk> and you very correctly said that now that the drug is approved in obstructive hypertrophic cardiomyopathy. Our intent of course is based on the data from the Maverick Phase II study in the law.

Term follow from there.

Samit Hirawat: We are initiating the Phase III program later this year in non-obstructive hypertrophic cardiomyopathy. Now of course the HFPAF study is a small phase 2 study which is a proof of concept trial looking at the doses of 2.5 raised up to 5 mg dose and that data when we have the proof of concept will then open the door for future indication expansion to HFPAF and at that time we'll be able to have the decision around what dose and how to manage the overall profile in terms of dosing these patients in that indication.

We are initiating the phase III program later this year in non obstructive hypertrophic cardiomyopathy.

Of course, the <unk> study is a small phase II study, which is a proof of concept trial looking at the dose of two five days up to five milligrams.

Those in and that data when we have the proof of concept well then open the door for future <unk>.

Indication expansion with Iff's and at that time, we'll be able to have the decision around what goes and how to manage the overall.

Profile in terms of dosing these patients in that indication so more to come as the data evolves and we understand it better the application of this medicine in that disease first and vacuum out we have two studies are ongoing as you know with a phase III study and use of <unk> and then of course as you said later this year, we'll see the data from the Adobe and <unk>.

Samit Hirawat: So more to come as the data evolves and we understand it better the application of this medicine in that. For syndacumab, we have two studies that are ongoing, as you know, with a phase 3 study in eosinophilic esophagitis.

Samit Hirawat: And then, of course, as you said, later this year, we'll see the data from the atopic dermatitis. Now, that is the field where we have understood quite well because of the competition that is out there and the data that are out there. So the data that needs to evolve from the phase 2 study needs to be in a place where we can ultimately understand the applicability of this drug and the population where it should be used.

<unk> now that is a field, where we have understood quite well because of the competition that is out there in the data that are out there. So the data that needs to evolve from the phase two study needs to us.

To be in a place where we can ultimately understand the applicability of this drug and the population that it should be used so again, let's wait and watch when the data evolves, we will be able to discuss that and give more specifics. If those data are significant and clinically meaningful to go into phase III studies. Thank you.

Samit Hirawat: So again, let's wait and watch. When the data evolves, we'll be able to discuss that and give more specifics if those data are significant and clinically meaningful to go into. Okay, can we go to the next one? Okay, can we go to the next question, please? Okay, can you can you hear us? I'm not sure if you can hear us, Sergei. We're here if you can. Hello? Sergei?

Alright, let's go to the next one.

Okay can we go to the next question. Please.

Okay.

Okay can you can you hear us.

Okay.

Okay.

I'm not sure if you can hear a surrogate we're here if you can.

Okay.

Okay.

Hello.

Very good.

Operator: Excuse my interruption, shall we move on to the next question? Yeah, go ahead. I think we're at time at this point. Maybe we should wrap up the call, Giovanni. Yeah, I'm sorry for the last minute issue.

Yes, Keith.

Shall we move on on the next question.

Yes, please yes.

Go ahead.

I think we're at time at this point, maybe we should wrap up the call Giovanni Yes, Im sorry for the last minute issue. Let me just thank you all again for joining our call and obviously our teams that are available to answer any additional questions you may have.

Giovanni Caforio: Let me just thank you all again for joining our call. And obviously our teams are available to answer any additional questions you may have. So in concluding, let me just say we're really pleased with the two approvals this quarter, the continued progress we've made with our pipeline, and our strong commercial performance. And that makes me really confident in our ability to continue to execute. We are very well positioned for growth.

So in concluding let me just say, we're really pleased with the two approvals. This quarter. The continued progress we've made with our pipeline and a strong commercial performance.

That makes me really confident in our ability to continue to execute.

We are very well positioned for growth and I just wanted to thank our employees for their continued hard work.

Giovanni Caforio: And I just want to thank our employees for their continued hard work and dedication. With that, we'll close the call. And again, Tim, Nina, and the rest of the team remain available for answering any additional questions you may have. Thanks, everyone. This concludes today's call. Thank you for your participation. You may now disconnect. Thanks for watching!

And dedication with that we'll close the call and again, Tim Nina and the rest of the team remain available for answering any additional questions. You may have thanks, everyone.

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

Okay.

Okay.

Yes.

Yes.

Yes.

Okay.

Yes.

Hum.

Yeah.

Yes.

Hum.

Okay.

Okay.

Yeah.

Yeah.

Yeah.

Okay.

[music].

Yeah.

Uh huh.

Yeah.

Yes.

Yes.

Right.

Okay.

Okay.

Yes.

Yeah.

Yeah.

[music].

Yeah.

Okay.

Okay.

Yeah.

Okay.

Okay.