Q4 2019 Earnings Call

Good day and welcome to do Bristol Myers Squibb 2019 fourth quarter results Conference call Today's conference is being recorded.

Operator: Good day, and welcome to the Bristol-Myers Squibb 2019 fourth quarter results conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. John Elgar, Senior Vice President, Public Affairs, and Investor Relations. Please go ahead, sir.

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This time I would like to turn the conference over to Mr., John Elicker Senior Vice President public the person Investor Relations. Please go ahead Sir.

John Elgar: Morning Anna, and thanks everybody for joining us today as we talk about our quarter and, importantly, the outlook for 2020 and beyond. I'll take care of the legal requirements before I turn it over to Giovanni, both Giovanni and David Elkins.

Good morning, Ana and thanks, everybody for joining us today as we talk about four quarter.

Currently the outlook for 2020 beyond.

I'll take care of.

Requirements before I turn it around the Giovanni both Giovanni David Elkins, our CFO will have prepared remarks, joining us for Q1, I as well or so much here a lot part chief Medical officer, and head of development, Chris Burner, a chief commercialization officer and the people that are present for hematology.

John Elgar: Our CFO will have prepared remarks, and then joining us for Q&A as well are Samit Hirawat, our Chief Medical Officer and Head of Development, Chris Boerner, Chief Commercialization Officer, and Adeem Ahmed, our President of the hematology business. During the call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements, even if our estimates change. We will also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available on our website, and just to remind everybody, in case you haven't seen them, there are slides to go along with today's call. And with that, I'll turn it over to Giovanni.

She business during the call, we'll make statements about the company's future plans and prospects that constitute forward looking statements actual results may differ materially from Roche indicated bugs forward looking statements as a result of various important factors, including those discussed in the company's FCC filings. These forward looking statements represent or estimates as of today it 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 arrest and that's changed.

Also focus our comments from a non-GAAP financial measures, which are adjusted to exclude.

Certain specified items reconciliations of these non-GAAP financial measures to most comparable GAAP measures are available for.

And just to remind everybody in case, you have I haven't seen them there our slides to go along with today's today's call without I'll turn it over to your long.

Giovanni Caforio: Dr. Giovanni. Thank you, John. And good morning, everyone. Welcome to our fourth quarter and full year 2019 earnings call. I am pleased to be here today to discuss the earnings results of our new company for the first time. On slide four, let me start by reminding you who the new Bristol-Myers Squibb is today. Our mission hasn't changed; we are focused on discovering, developing, and delivering innovative medicines that help patients living with serious diseases. We aspire to be the leading biopharma company in the world. Our strategic foundation remains centered on combining the scale and resources of a pharma company with the agility and speed of a biotech. I am proud of the strength and talent of our people, who are focused on transforming patients' lives through science.

Thank you John and good morning, everyone welcome to our fourth author and 40 year 2019 earnings call.

I'm pleased to be here today to discuss the earnings.

It's all about where new company for the first time.

On slide four let Mike let me start Mighty Minding, you, who then you Bristol Myers Squibb yesterday.

I wouldn't be shouldn't hasn't changed we have focused on discovering developing and delivering innovative medicines that help patients living with seniors diseases.

We aspire to be the leading Biopharma company in the industry.

Our strategic foundation remains centered on combining the scale and resources of a pharma company would be agility and speed of a biotech.

I'm proud of the strength and talent or by where people were focused on transforming patients' lives through science.

Giovanni Caforio: Moving to slide five, I am more encouraged about our company's potential today than I was a year ago. The strength of our performance in 2019 has positioned us very well for the future. As I look at 19, we've delivered strong in-line performance across our businesses and geography, and we've made important progress on our late stage pipeline. I'm pleased with how integration is going so far, with good progress across our business units and functions, as we remain on track to deliver $2.5 billion in. Of course, we have more work to do to integrate our processes, systems, and platforms, including IT, pricing, and accounting. Based on what I've seen to date, I'm confident about the successful integration of our. Turning to our financial outlook, I feel really good about the financial strength of the company. Our guidance reflects the earnings power and significant EPS growth outlook that we have as a company.

Moving to slide five I'm more encouraged about our company's potential today than I was a year ago.

The strength of our performance you 19 has positioned us very well for the future.

Who get 19, we've delivered strong in line performance across our businesses and geographies.

And we've made important progress on our late stage pipeline.

I'm pleased with how integration is going so far we good progress across our business units and functions as we remain on track to de lever 2.5 billion in synergies of course, we have more work to do to integrate our.

Also sees systems and platforms, including I.T. pricing in accounting.

Based on what I've seen to date I'm confident about the successful integration of our company.

Turning to our financial outlook I feel really good about the financial strength of the company our guidance reflects the earnings power.

Sure and significant EPS growth outlook that we have as a company.

Giovanni Caforio: We continue to see potential for significant cash flows to support debt reduction and continued investment in innovation. Finally, as I look forward, we have an unprecedented number of new drug launches in the near term horizon. These are all either first-in-class or best-in-class meds, and I am very encouraged by how prepared our teams are to maximize this launch opportunity. Now, let's move to the fourth quarter.

We continue to see potential for significant cash flows to support that reduction and continued investments in innovation.

Finally, as I look forward, we have an unprecedented number of new drug launches in the near term horizon.

He's at all either first in class and or best in class medicines, and I'm very encouraged by how prepared our teams are to maximize the slowing surepost.

Now, let's move to the fourth quarter, turning to slide six I'll give you my perspective before David provides more.

Giovanni Caforio: Turning to slide six, I'll give you my perspective before David provides more color on product performance. We've delivered strong growth across multiple key brands, many with double-digit growth. With respect to the IO franchise, I'm pleased with the excellent work of our teams in this area. POPDIVO grew on a full year basis, and though we're seeing some pressure in the U.S., as expected, we saw growth internationally and continue to view 2020 as a year of transition for the brand.

Current color on product performance.

We've delivered strong growth across multiple key brands Manny we double digit growth.

With respect to the IPO franchise I'm pleased with the excellent work of our teams in this area.

Opdivo grew on a 40 year basis and the we're seeing some.

I'm pressuring the U.S. as expected we saw growth internationally and continue to view 2020, as the Europe transition for the brand.

Giovanni Caforio: Looking forward, we have the potential for a new launch, supporting an Expected Return to Growth in 2021. This includes first-line lung cancer, studies 227 and 9LA, and our first-line renal cancer opportunity with 9ER and moving into earlier-stage disease with a number of adjuvant opportunities. Regarding lung cancer, let me talk briefly about Study 227.

Looking forward, we have the potential for new launches supporting an expected to return to growth in 2021.

These includes first.

Line lung cancer studies to do seven and finally.

Our first line renal cancer opportunity with 90, our and moving into earlier stage disease with a number of large event opportunities.

Regarding lung cancer, let me talk briefly about study to do seven.

Giovanni Caforio: Why we're disappointed by the position taken by the CHM. We continue to view the combination of Obdivo and Yervoy as a differentiated register, with the potential for long-term survival and one that should be available to patients. Going forward, we continue to focus on the review of Study 227 in the U.S., where it was granted priority with a PDUFA date in May, as well as the filing of 9LA in the US and worldwide. In summary, I am very encouraged by the strength of commercial execution across the enterprise in oncology, hematology, cardiovascular, and immunoscience. This is a clear demonstration of our leading commercial capabilities, which will be important to deliver on the exciting potential near-term launch opportunities ahead. Now, let's turn to slide 7.

While we're disappointed by the.

Position taken by the CHF beat we continue to view the combination of Opdivo and Yervoy as a differentiated regimen with the potential for long term survival and one that should be available to patients globally.

Going forward, we continue to focus on the review of study to do seven in the U.S.

But it was granted priority with up I do find aid in may as well as the filing on off nine delay in the U.S. and globally.

In summary, I am very encouraged by the strength of commercial execution I go across the enterprise you know apology hematology cardiovascular anyway.

Science.

He sees a clear demonstration of our leading commercial capabilities, which will be important to de lever on the exciting potential near term loan opportunities ahead.

Now, let's turn to slide seven.

Giovanni Caforio: In December, we attended our first medical meeting as a combined company at the American Society of Hematology, just a few weeks after we closed the subgene transaction. Importantly, we saw very good data rush for our hematology pipeline, including pivotal data for three products which are potentially approaching launch and encouraging data from the early pipeline. I believe that this reinforces the opportunity we have to broaden the hematology portfolio and sustain a leadership position in multiple fields. Let's turn to slide 8.

In December we attended our first the medical meeting as a.

Combined the company at the American Society of Hematology, just a few weeks after we closed the celgene transaction.

Importantly, we feel very good data at ash, what I want hematology pipeline.

Including people data for three products, which are potentially approaching launch and encouraging data from.

The early pipeline I.

I believe that these reinforces the opportunity we have to broaden the hematology portfolio and sustain a leadership position in multiple myeloma.

Let's turn to slide eight.

Giovanni Caforio: I feel good about the earnings power and growth outlook for the company moving forward. I am encouraged by the financial strength of the company this year. We see significant non-GAAP EPS growth from this year into next year, and we project continued non-GAAP EPS growth into 2022, although this will be moderated by the impact of generics on revenue.

I feel good about the earnings power and growth outlook for the company.

Moving forward.

I am encouraged by the financial strength of the company this year.

We see significant non-GAAP EPS growth from this year into next year.

And we project continued non-GAAP EPS growth into 2022.

The Beast.

We'd be moderated by the impact of generics on Revlimid.

Giovanni Caforio: David will provide more details on this guidance, but I am pleased with the strength of our inline business, our launch opportunities, our financial flexibility, and the breadth of our pipeline. And with respect to our launch opportunities, we expect important potential milestones over just the next few months. In March, the U.S. approval of Ozanimod for multiple sclerosis. In April, the expansion of Rebolzil in MDS. In May, the U.S. approval of Obdivo Placiervoi in the first nine languages.

David will provide more details on these guidance, but I am pleased with the strength of our E line business, our launch opportunities, our financial flexibility and the breadth of our pipeline.

And with respect to our launch opportunities.

We expect important potential milestones over just the next few months.

In March the U.S., a pool of US Oneq was anymore in multiple sclerosis in April the expansion of rebels Hill in Mds in May the U.S. approval of Opdivo plus Yervoy in first line.

Lung cancer.

Giovanni Caforio: Additionally, we continue to advance our regulatory filings for LysoCell, IdaCell, and CC4HP. Taken together, the company is in a strong position, and this is reflected in the performance of our business and the outlook we are providing today. Turning to slide 9, to realize our potential, we will continue to deliver on the inline business, drive integration and synergy capture, maximize the value of our launch opportunities, and advance our pipeline. Beyond this, I continue to be encouraged by our financial strength and flexibility, and now this enables us to continue to invest in innovation to deliver important medicines for patients. All of this gives me confidence in our near and long-term opportunities as a company. I'm looking forward to our Investor Day, which will be held on April 2nd in New York. My team and I will be able to talk in greater detail about the many opportunities ahead of us. Speaking of my team, I am very pleased to be joined today by David Elkins and Nadim Ahmed. Welcome to them both. At this point, I will hand it over to David, our new CFO, to walk you through the financials.

Additionally, we continue to advance our regulatory filings for like yourself, Idasl and Cc 486.

Megan together the company Easiness strong position and these are reflected in the performance of our business and the outlook we are providing today.

Turning to slide nine.

Realized our potential we will continue to the LIBOR on the line business.

But I didn't decoration and synergy capture maximizes the value of out what launch opportunities and advancing our pipeline.

Beyond that this I continue to be encouraged by or financial.

Real strength and flexibility and out these enables us to continue to invest in innovation to de lever important medicines for patients.

All of this is what gives me confidence in our near and long term opportunities as a company.

I'm looking forward to our Investor day.

Which will be held on April 2nd in New York City with my team and I would be able to talk in greater detail about the many opportunities ahead of us.

Speaking of my team I'm very pleased to be joined today by David Elkins and at the moment welcome to both.

At this point I will hand it over.

But to David I wouldn't you CFO.

Walk you through the financials, they did not get your body and good morning, everyone.

David V. Elkins: Thank you, Giovanni. Good morning, everyone.

David V. Elkins: Having benefited from working in this industry for over 20 years, I could not be more excited about the growth potential and earnings power of bringing these two companies together. I've been very impressed by the employees of the combined company, and I'm encouraged by the breadth of opportunities we have ahead and our ability to deliver important new medicines to patients. Now, let's turn our focus to performance in 2019.

Having benefited from working in and in this industry for over 20 years I could not be more excited about the growth potential earnings power of bringing these two companies. Together then very impressed by the employees to the combined company I'm encouraged by.

The breadth of opportunities we have ahead in our ability to deliver important new better medicines to patients.

Now, let's turn our focus.

Brokers to the performance in 2019 to start the business continued to deliver strong performance in the fourth quarter, 6% revenue growth on a pro forma basis. This performance serves as a strong.

David V. Elkins: This performance serves as a strong foundation for the future outlook of the company, which we will cover in a moment. Giovanni gave you some brand insights, and now I will provide you with additional color on the underlying performance of the business. Beginning with Upviva on 5-11, we had continued strong commercial excellence in the quarter, where our teams continued to operate very well in increasingly competitive markets. Let me provide you with a perspective on how we see the business at the moment. From a U.S. demand perspective, we're seeing sequential low single-digit declines driven by the headwinds we've described in the past. Note that demand trends are more studied than reported sales, which are incrementally impacted by buying patterns both in the government channel and from wholesalers. Now, with respect to some key indications, we expect steady performance in our melanoma business, driven by our leadership in both the metastatic and adjuvant setting. In non-small cell lung cancer, the size of the eligible pool of second-line patients is leveling off at roughly one-third.

For the future outlook of the company, which will cover in a moment.

Bonnie gave you some brand insights.

We provide you with additional color I mean underlying performance of the business.

Getting with a few though on slide 11, you had continued strong commercial excellence in a quarter, where teams continue to operate very well and increasingly competitive.

Markets.

Let me provide you with the perspective on how we see the business at the moment.

From a U.S. demand perspective, we're seeing sequential low single digit decline driven by the headwinds we've described in the past.

Note that demand trends are more study than reported sales, which were incrementally impacted by buying patterns both into.

I'm going to channel and from wholesalers.

Now with respect to some t. indications, we expect steady performance in a melanoma business driven by our leadership in both metastatic and management setting.

In non small cell lung cancer the size of the eligible pull a second line patients is leveling off at roughly one third.

David V. Elkins: In the first-line RCC space, we continue to perform well, where Opdivo Yervoy remains the standard of care in intermediate and poor-risk patients, and we've seen stabilization in this indication as well. Internationally, we have seen very strong commercial execution in all our key markets, resulting in encouraging growth in the brand. We expect further growth as we continue to secure reimbursement for first-line RCC. With respect to First Line Lung, we look forward to the opportunity to launch 9LA in the same setting and make Updevo available for patients in these markets.

First line RCC space, we continue to perform well we're up vivo yervoy remains the standard of care and intermediate and poor risk patients and we've seen stabilization in this indication as well.

Internationally, we've seen very strong commercial execution and all are key markets, resulting an encouraging growth and the brand.

We expect further growth as we continue to secure reimbursement in first line RCC.

With respect to first line lung, we look forward to the opportunity to launch nine L.A. and the thing setting and making up vivo available for patients in these markets.

So stepping back we continue to see 2020 as a transition year for us.

David V. Elkins: Stepping back, we continue to see 2020 as a transition year for Updevo with demands, pressures in the US, and growth in our international business. But more importantly, as we move into 2021, we believe we have a strong foundation for growth fueled by potential new indications, including first line lumps. Now, let's turn to eloquence on slide 12.

So with demands pressures in the U.S. and growth in our international business.

More importantly, as we move into 2021, we believe we have a strong foundation for growth fueled by potential new indications, including first line lung.

Now, let's turn to Eloqua it sounds like 12.

David V. Elkins: In the fourth quarter, we saw continued strong sales growth of 19% globally due to increased demand for both AFib and VTE. In the US, we saw 18% sales growth in the fourth quarter versus the prior year, despite increased discounts for the Medicare coverage gap. Eloquist continues to increase its share at the expense of Warframe in an expanding NOAC class.

In the fourth quarter.

Sure. We saw continued strong sales growth of 19% globally due to increased demand in both they fit NPD.

In U.S., we fell 18% sales growth in the fourth quarter versus prior year, despite increased discounts for Medicare coverage that.

Eloquence continues to increase its share at the expense of war friend.

And then expanding no act class at the classes expanded seen Alex was taking share at the expense of other no acts.

David V. Elkins: As the cost has expanded, we've seen Alcoa taking share at the expense of other NOACs. Shown on this slide is the difference between new brand share and total brand share in the U.S. for both Warfarin and Eloquist. This highlights the continued growth opportunity for the class and the brand. We are also very pleased with the growth of Eloquist internationally, where we have a leading share in a growing number of markets, resulting in 21% sales growth in Q4 versus the same quarter last year. We continue to view this brand, which remains the number one NOAC globally, as one position for significant future growth and continued opportunity for patient care. We also see strong growth in our multiple myeloma franchise. As you will see on slide 13, Revlimid continued to grow in the fourth quarter, driven by triplet regimens and increased treatment duration, increasing 10% year-over-year on a performance basis. Pamela saw significant growth of 23% in Q4 versus last year on a performance basis, driven by increased demand and duration of therapy. We expect growth to continue across both brands through increased adoption of the triplet regimens and increased duration of treatment.

Shown on this slide is the difference between new brand share and total brand share in U.S. for both warfarin and eloquence.

This highlights the continued growth opportunity for the class and the.

Brad.

We're also very pleased with the growth developed with internationally, where we have a leading share in a growing number of markets, resulting in 21% sales growth in Q4 versus the same quarter last year.

We continue to do this brand, which remains the number one Noah globally as one position for significant future growth.

Continued opportunity for patients.

We also see strong growth in our multiple myeloma franchise as you will see on slide 13, Revlimid continue to grow in the fourth quarter, driven by triplet regimens and increased treatment duration, increasing 10% year over year on a pro forma basis.

Panelists saw significant growth of 23% from Q4 versus last year on a pro forma basis, driven by increased demand and duration of therapy.

Expect growth continue across both brands due to increased adoption of the triplet regimens and increase duration of treatment.

I'll now turn to slide 14.

I mean and review our fourth quarter PML.

This was an unusual quarter for the company as a result of the close of the Celgene acquisition on November Twentyth.

Including on a reported piano or the approximately six weeks of results from the legacy Celgene business post the transaction close.

David V. Elkins: I'll now turn to slide 14 and review our fourth quarter P&L. This was an unusual quarter for the company as a result of the close of the Celgene acquisition on November 20. Included in our report at P&O are the approximately six weeks of results from this legacy cell gene business post the transaction closed. As it relates to the non-debt P&L, we now include the impact of stock-based compensation in our operating income, which was previously specified for Celgene when it was a standalone company. With respect to OI&E, since the close of the transaction, we have incorporated both the interest expense on legacy Celgene debt and have begun recognizing interest expense on acquisition financing that had previously been specified since its issuance last May. Also, our Q4 tax rate was primarily impacted by several one-time favorable items, including the resolution of uncertain tax provision and provision adjustments for filings in the U.S. and other markets.

As it relates to the non-GAAP you know.

We now include the impact of stock based compensation and our operating expense.

She was previously specified for Celgene when it was a standalone company.

With respect Oh, I mean since the close of the transaction we have incorporate both the interest expense on legacy Celgene debt and have begun recognizing interest expense on acquisition financing.

That had previously been specified since its issuance last may.

Also our Q4 tax rate was primarily impacted by several onetime favorable items, including the resolution of uncertain tax provision and provision adjustments for filings in the U.S. and other markets.

Looking to 2020 from a financial support.

Respective on slide 15, we provided guidance, reflecting the strength and momentum in the business.

Plus our new large products and indications and the realization of synergies.

First it's important to note that are guidance on non-GAAP earnings per share reflects expected 40% accretion.

And that Standalone CNL.

And includes significantly higher operating margin than in the past.

Seven unique circumstances as a new company. This your guidance includes more detail than we typically provide.

So let me provide some color on the T. line items.

Revenue represents growth on a pro forma base.

David V. Elkins: Looking to 2020 from a financial perspective, on slide 15, we provided guidance reflecting the strength and momentum in the business, plus our new launch products and indications and the realization of Synergy. First, it's important to note that our guidance on non-GAAP earnings per share reflects the expected 40% accretion to the BMS standalone P&L and includes significantly higher operating margins than in the past. Given the unique circumstances as a new company, this year's guidance includes more detail than we typically provide. So, let me provide some color on the key line items.

It is driven by opportunities, we see in our prioritize portfolio more than offsetting declines in our established friends.

We expect the continued decline in established brand portfolio due to strategic course choices and competitive dynamics.

First we expect bear food to continue to decline based on the majority that drug and generic.

Competition.

We expect five days it will be impacted in 2020 by generics in Europe.

And we expect the rest of the established brands portfolio to decreased by about one third compared to the 2019 pro forma results.

This is driven by the full year impact if that gives the divestiture as well as further generic version of the.

RV portfolio.

Oh I need includes incremental interest expense offset by royalties.

From an interest perspective in our non-GAAP PML interest expense will be driven by approximately $45 billion a debt at the weighted average interest rate of 3.4%.

David V. Elkins: Revenue represents growth on a performance basis driven by opportunities we see in our prioritized portfolio, more than offsetting declines in our established range. We expect a continued decline in our established brand portfolio due to strategic course choices and competitive dynamics. First, we expect Barracuda to continue to decline based on the maturity of that drug and generic competition; we expect by days it will be impacted in 2020 by generics in Europe, and we expect the rest of the established brands portfolio to decrease by about one third compared to the 2019 performance results. This is driven by the full year impact of the UPSA divestiture, as well as further generic erosion of the HIV portfolio. OI&E includes incremental interest expense offset by the rule of, From an interest perspective, in our non-debt P&L, interest expense will be driven by approximately $45 billion of debt at a weighted average interest rate of 3.4%.

Note that.

For me Astra Zeneca are stepping up and 2020 and we also expect higher royalties on our PD one patents.

Altogether, we expect royalties to roughly offset interest expense in here.

Our separate line items for R&D and <unk> best DNA. Each include the impact of stock based compensation as well as deals.

Synergies, we expect to realize about one third of the total two and a half billion dollar synergies this year.

With respect to stock based compensation BNS includes the impact of Celgenes employee stock based comp and our operating expense.

Which negatively impacts our non-GAAP DNL.

The full year amount of the spec.

Based compensation for Celgene in 2019 was roughly $800 million on announced that basis, which was incremental to the Vms standalone stock based compensation.

We expect levels of stock based compensation to remain elevated and 2020 and begin to taper down overtime as the Celgene and BMS legacy plans converge.

We also want to remind you on slide 16, you evolution of our share count.

Basic share count as of the end of 29 team was impacted by the 715 million of new issuances as result of the Celgene conversion and by the impact of the I saw.

David V. Elkins: Note that royalties from AstraZeneca are stepping up in 2020, and we also expect higher royalties on our PD-1 patent. Altogether, we expect royalties to roughly offset interest expense in the year for R&D and SG&A. We expect to realize about one-third of the total $2.5 billion synergies this year. With respect to stock-based compensation, BMS includes the impact of Celgene's employee stock-based compensation in our operating income, which negatively impacts our non-GAP P&L.

Going forward or 2020 basic share count will be impacted by.

Three factors.

The number of stock options exercise.

The finalization of the Ace our program.

An additional share repurchases, which provides us flexibility to manage the potential future dilution.

Remember there will continue to be a dilutive impact for the stock options that remain in the money.

That said.

No additional options will be granted under the legacy selfie plan. So overtime. This impact will lessen as the compensation plans from the both legacy companies converge.

As you can see we've guided our weighted average share count for the year to be approximately 2.3 billion shares for the year.

David V. Elkins: The full year amount of the stock-based compensation for Celgene in 2019 was roughly $800 million on a non-GAAP basis, which was incremental to the BMS standalone stock-based compensation. We expect levels of stock-based compensation to remain elevated in 2020 and begin to taper down over time as the Celgene and BMS legacy plans converge. We also want to remind you, on slide 16, of the evolution of our ShareCell. Basic share count as of the end of 2019 was impacted by the 715 million new issuances as a result of the Celgene conversion and by the impact of the ASR. Going forward, our 2020 basic share count will be impacted by three factors. A number of stock options exercised, the finalization of the ASR program, and additional share repurchases, which provides us flexibility to manage the potential future dilution. Remember, there will continue to be a dilutive impact for the stock options that remain in the money. That said, no additional options will be granted under the legacy Celgene plan, so over time, this impact will lessen as the compensation plans from both legacy companies converge. As you can see, we've guided our weighted average share count for the year to be approximately 2.3 billion shares for the year. Now, on slide 17.

Now on slide 17.

As we look beyond 20 timing, we see a robust growth in 2021.

Driven by the current portfolio as well as new expected launch opportunities and the impact of continued synergies all of which is reflected in your EPS guidance.

We expect continued growth into 2020.

To why acknowledging this will be gotta moderated growth rate due the generic competition for revlimid.

It's important to mention that we do not anticipate continually updating our long term guidance throughout the year.

Now, let's turn to capital allocation on slide 18.

As we've said in the past we continue to expect significant.

<unk> cash flow from the newly combined businesses and we will continue to employ a balanced approach to capital allocation.

This is development is a key enabler of our strategy and therefore remains attack pop capital priority.

We also remain committed to the dividend as evidenced by EUR 10, plus year track record of annual increases and art.

Recent increase of almost 10% in December.

At the same time, we remain fully committed to de leveraging and achieving our 1.5 times gross debt to EBITDA ratio by the close of 2023.

As you are aware, we have approximately $10 billion in bonds maturing over the next three years, providing an opportunity.

Or two to reduce total debt.

Finally relate to share repurchases.

We repurchased 105 million shares in 2019 99 million in Q4 under the $7 billion SAR, mostly due to the 80% retired upfront.

The remaining roughly 20% of they pay us are expected.

To be completed by the end of Q2 this year.

David V. Elkins: As we look beyond 2020, we see robust growth in 2021 driven by the current portfolio, as well as new expected launch opportunities, and the impact of continued synergies, all of which is reflected in the EPS guidance. We expect continued growth into 2022, while acknowledging this will be at a moderated growth rate due to generic competition for registrants. It's important to mention that we do not anticipate continually updating our long-term guidance throughout the year.

As we announced today, we've increased our share repurchase authorization by 5 billion to $6 billion. This provides us with the flexibility to execute disciplined share repurchases to manage the dilution from stock based compensation and stabilizing the share count into the next year.

Other typically we don't provide quarterly guidance I'd like to remind you of the seasonality of the legacy Celgene portfolio, specifically Revlimid revenue was historically a bit later in the first quarter than the full year average run rate.

Before we moved to the question and answer session I just wanted to reiterate that we feel really good.

About the growth outlook and financial flexibility of the business.

And if reflected this in our guidance.

The company's and strong position to embark on its next chapter in delivering important medicines for patients.

David V. Elkins: Now let's turn to capital allocation on slide 18. As we've said in the past, we continue to expect significant cash flow from the newly combined business, and we will continue to employ a balanced approach to capital allocation. Business development is a key enabler of our strategy and therefore remains a top capital priority.

Now I'll turn the call back over to John and Giovanni for the question then.

Thanks, David and and I think we're ready to go to the QNX session.

Thank you if you would like to ask a question. Please press star one on your telephone keypad experiencing speakerphone. Please make sure you need functioning targets. So now you're taking into each of equipment and that's again I want to ask a question we will pause for just the moments, killing now everyone.

David V. Elkins: We also remain committed to the dividend, as evidenced by our 10-plus year track record of annual increases and our recent increase of almost 10% in December. At the same time, we remain fully committed to leveraging and achieving our 1.5 times gross debt to EBITDA ratio by the close of 2023. As you are aware, we have approximately $10 billion in bonds maturing over the next three years, providing an opportunity to reduce total debt.

A question.

Your next weekend Star Wars.

Yes, good question.

Our final question from clean.

<unk> from JP Morgan. Please go ahead.

Great. Thank so much of the questions.

They're just to hear on top of the though first I know everybody you touched on a little bit in the prepared remarks, but here's elaborate on the first line lung strategy in Europe post the last weeks to Q seven update and then we think about first line lung in the U.S.

David V. Elkins: Finally, relating to share repurchases. We repurchased 105 million shares in 2019, 99 million in Q4 under the $7 billion ASR, mostly due to the 80% retired up front. The remaining roughly 20% of the ASR is expected to be completed by the end of Q2 this year. As we announced today, we've increased our share repurchase authorization by $5 billion to $6 billion. This provides us with the flexibility to execute disciplined share repurchases to manage the dilution from stock-based compensation and stabilize the share count into the next year. Although we typically don't provide quarterly guidance, I'd like to remind you of the seasonality of the Legacy Celgene Portfolio. Specifically, Revlimid revenue is historically a bit lighter in the first quarter than the full year average. Before we move to the question and answer session, I just wanted to reiterate that we feel really good about the growth outlook and financial flexibility of the business and have reflected this in our guidance. The company is in a strong position to embark on its next chapter in delivering important medicines for patients. I'll now turn the call back over to John and Giovanni for the question and answer.

As you grow your Hawaii and.

The two to seven data the primary focus or do you feel that the nine that way regimen of chemo Opdivo Yervoy I will be the bigger focus and trying to figure how you're balancing those two datasets and then my second question was another one just everything about 2020 for up do you, though when you look at where the street shaking out here she thinks about a 5%.

Erosion for Opdivo beside this year versus 2019 do you feel like consensus properly captures the balance of the second line lung erosion relative to the growth or seasons and these other indications. Thanks so much.

Ah yes, thank you Chris.

So first of all let me let me just say as I mentioned in my remarks, our focus in Europe.

For first line lung cancer, obviously has shifted to.

Nine L.A., which we believe has you know and we've said before is and if there's any important study let me.

And just ask crease burden there to give you a perspective on our overall strategy for first line lung cancer in.

The U.S. as we think about the two trials and then Chris can provide some perspective on them Tivo.

Performance and and the various components of that in 2020 as well yeah. Chris. Thanks for the question I mean, I think we continue to see two to seven to nine outlay as being bought out in the U.S. very much in conjunction with one with one another.

If you go back what we are consistently from physicians, who have seen the two to seven data is that number one there impressed with the potential for long term survival with dual Io therapy, they know to be a depth and durability of complete remissions, all coming with a very manageable safety profile and so they see that as an.

John Elgar: Thanks, David. And Anna, I think we're ready to go to the Q&A session.

Operator: Thank you. If you would like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment.

Important opportunity for patients, who either don't need or don't want chemotherapy.

Operator: And that's again star number one to ask a question. We will pause for just a moment to allow everyone an opportunity to signal for questions. And that's, again, star number one to ask a question. We take our first question from Chris Schott from J.P. Morgan. Please go ahead.

And incidentally I would say that the approved the NCCN listing that to a listing that we got back in December as a recognition both of the unmet need that continues to exist in first line lung cancer as well as the potential that.

Exists for.

Dual Io therapy, what nine L.A. then brings to the table is answering the question of for those patients who do need chemotherapy does concomitant chemotherapy two cycles in this case.

Chris Schott: Will be the bigger focus? I'm trying to figure out how you're balancing those two data sets. And then my second question was another one just as we think about 2020 for Updevo. When you look at where the street's shaken out here, which I think is about a 5% erosion for Updevo this year versus 2019, do you feel that consensus properly captures the balance of the Second Line Lung erosion relative to the growth you're seeing in some of these other indications? Thanks so much.

Along with dual Io therapy provide a benefit and we're very happy to see as a second study that demonstrates overall survival so as physicians in the.

Think about these studies they very much think about then in combination with one another and that's an important part of how we're going to think about our long term strategy in first line lung cancer as it relates to 2020 and how we think about the business. Let me say just a couple of things first of all the business for Opdivo in the U.S. continues to.

Performed inline with our expectations in second line lung cancer eligibility is still on the order of 30% to 35%. We expect that's going to flatten out around 30%. This year our shares are holding stable in the 35% to 40% range. The business continues to be stable in metastatic melanoma. We continue to have a leadership position imagine that melanoma and.

Giovanni Caforio: Thank you, Chris. First of all, let me just say, as I mentioned in my remarks, our focus in Europe for first-line lung cancer has obviously shifted to 9LA, which we believe, as you know and we've said before, is an important study. Let me just ask Chris Boerner to give you a perspective on our overall strategy for first-line lung cancer in the U.S. as we think about the two trials, and then Chris can provide some perspective on Opdivo performance and the various components of that in 2020 as well.

And in first line renal business is stable and are approved indications on as we think about this year as David mentioned the business is going to continue to still be under pressure.

As a reminder, that pressure really comes from three tumors. Its second line lung cancer, we've talked about the dynamics, there and it's small cell and head and neck.

Chris Boerner: Yeah, Chris, thanks for the question. I mean, I think we continue to see 227 and 9LA as being thought of in the US very much in conjunction with one another. If you go back, what we hear consistently from physicians who have seen the 227 data is that, number one, they're impressed with the potential for long-term survival with dual IO therapy. They note the depth and durability of complete remissions, all coming with a very manageable safety profile. And so they see that as an important opportunity for patients who either don't need or don't want chemotherapy. And incidentally, I would say that the NCCN listing, a 2A listing that we got back in December, is a recognition both of the unmet need that continues to exist in first-line lung cancer as well as the potential that exists for dual IO therapy.

And in those two tumors, it's a very similar dynamic to lung cancer, where you've seen competitive approvals in the first line impacting eligibility in the second line, but I would say importantly, our assumption for this year is that our stare our shares in the second line setting across those tumors remained stable, it's just stable within a smaller pool of patients.

And.

Again as I, we said earlier in the remarks, Chris what we're not commenting exactly on guidance for the growth of people. This year, we remain confident with growth going into 2021 and that's.

Our focus, particularly as it relates to.

In preparation for launches and commercial execution.

We go to the next question please Ana.

We take our next question from Seamus Fernandez from Guggenheim. Please go ahead.

Oh, thanks, very much so I'm actually I'd love to ask you guys about the celgene portfolio a little bit.

Rather than focusing on the books a portfolio.

One of the.

Products that we learned about it as well.

Chris Boerner: What 9LA then brings to the table is answering the question of for those patients who do need chemotherapy, does concomitant chemotherapy, two cycles, in this case, along with dual IO therapy provide a benefit? And we're very happy to see a second study that demonstrates overall survival. So as physicians in the US think about these studies, they very much think about them in combination with one another.

All of the days the opportunity I was just hoping you might be able to help put that in contact for us to help us understand what may be an underappreciated opportunity in the Bristol story.

And particularly something.

My fault outside of the TV and maybe this is a bit of a surprise upside and then also would you updated on both saw mob development opportunity.

You know, maybe just put in context, where you'd see that saw mob portfolio.

Delivering that.

The most upside as we talked to position.

The feedback that we got it is but this is a pretty straight forward opportunity point physician to.

We paid some color photographs on both Revlimid and Pomalyst. So just love to get your thoughts on both of those opportunities. Thanks.

Chris Boerner: And that's an important part of how we are going to think about our long-term strategy for first line lung cancer. As it relates to 2020 and how we think about the business, let me say just a couple of things. First of all, the business for Opdivo in the U.S. continues to perform in line with our expectations. In second-line lung cancer, eligibility is still on the order of 30 to 35 percent. We expect that it's going to flatten out around 30 percent this year.

Thank you Seamus, let me ask the summit to start and give you a perspective, both on a cc 486 and then.

Sell modes, and Nadeem will make some comments.

From a commercial perspective. Thank you think your same answer the question I think you already teed up the overall portfolio.

<unk>.

What comes from the Celgene side of things in terms of hematology.

They're certainly beyond the ones that we've already talked about from derivatives and Indra Big Cc four to six certainly adds onto that cc four to six study in patients with acute myeloid leukemia, and certainly a very important data set that were presented at ash looking at.

Chris Boerner: Our shares are holding stable in the 35 to 40 percent range. The business continues to be stable in metastatic melanoma. We continue to have a leadership position in adjuvant melanoma, and again, in first-line renal, our business is stable in our approved indications. As we think about this year, as David mentioned, the business is going to continue to be under pressure. As a reminder, that pressure really comes from three tumors. It's second-line lung cancer, as we've talked about the dynamics there, and it's small cell and head and neck. And in those two tumors, it's a very similar dynamic to lung cancer, where you've seen competitive approvals in the first line, impacting eligibility in the second line. But I would say, importantly, our assumption for this year is that our shares in the second-line setting across those tumors will remain stable. It's just stable within a smaller pool of patients.

Patients with email.

Have received a induction without without consolidation chemotherapy and then achieve a complete response with or without complete recovery of the bone marrow and what we saw over there does of course, the overall survival improvement as well as an improvement in the relapse free survival and this isn't.

Oral agent so convenience of delivery for these patients becomes very very important and this is a first and only treatment that has shown a survival benefit in the maintenance setting. So we remain excited about that and we're looking forward towards a discussions with the authority in the and the filings were going forward of course over here. We also continue to think.

Think about the overall lifecycle management plan without portfolio and the combinations that could be available in the future.

As it comes to the Submarkets and then I would pass it onto the deemed to comment more on I think settlements I, certainly a very very exciting.

Addition to the overall portfolio and the I've a material that we look forward to developing and most of.

Chris Boerner: And again, as we said earlier in the remarks, Chris, while we're not commenting exactly on guidance for the growth of Bilbo this year, we remain confident with growth growing into 2021. And that's our focus, particularly as it relates to preparation for launches and commercial execution.

My though.

We see this as a absolute necessary opportunity and one of the datasets ever presented at ASCO 2019 workforce Cc to 20, where we saw that patients who had to see prior treatment with Imids protease inhibitors data tumor mab are they still went on to.

I would have sponsored of 31% and these are durable responses that we saw in this late night setting. So we have additional times for not only cc to 20, but cc 480, which is another settlement looking at multiple myeloma setting and their multitude of opportunities without overall portfolio of cell therapy that is.

Giovanni Caforio: Can we go to the next question, please, Anna?

Operator: We take our next question from Seamus Fernandez from Guggenheim. Please go ahead. Oh, thanks very much.

Seamus Christopher Fernandez: Thank you very much. Actually, I'd actually like to ask you guys about the Celgene portfolio a little bit rather than focus on Bristol.

The T cell Engagers there, we will continue to think about how to do a treatments.

Seamus Christopher Fernandez: Portfolio. One of the

For further improvement in the outcome of these patients where youre still does not exist. So we'll we'll be sharing those plans in the coming.

Seamus Christopher Fernandez: www.bristol-myers-squibb.com Maybe just put in context where you see the Selmod portfolio delivering the most upside. As we talk to physicians, some of the feedback that we get is that this is a pretty straightforward opportunity for physicians to treat patients that have progressed on both Revlimid and Pomalyst. So, just love to get your thoughts.

Months and as we look forward, but let me pass it onto the deemed to talk a little bit more from the course of perspective. Thanks summit.

And then thank you for the question Seamus. So if you think about frontline on newly diagnosed A.M.L. across a U five and the U.S. about 33000 patients at about two thirds of those patients eligible for him intensive chemotherapy in.

Seamus Christopher Fernandez: I would like to get your thoughts on both of those opportunities. Thanks.

Giovanni Caforio: Thank you, Seamus. Let me ask Samit to start and give you a perspective both on CC 486 and then cell modes, and Nadim will make some comments from a commercial perspective. Thank you.

That's the patient group that we studied and the unmet need even in newly diagnosed I am always very high so.

With the elderly patients you have a five year survival only about 15%.

And 80% of these patients will relapse within 18 months so to have a treatment that adds 10 months overall survival and doubles the relapse free survival is going to be really important so were very excited about the opportunity and I am mill.

Samit Hirawat: I think you've already teed up the overall portfolio from what comes from the Celgene side of things in terms of hematology, where certainly beyond the ones that we've already talked about from RIVO and ENRIBIC, CC486 certainly adds to that. The CC486 study in patients with acute myeloid leukemia was certainly a very important data set that was presented at ASH looking at patients with AML who have received induction with or without consolidation chemotherapy and then achieved a complete response with or without complete recovery of the bone marrow. And what we saw over there is, of course, an overall survival improvement.

And I'd also remind you that this gives us another opportunity to once again establish the maintenance treatment paradigm in another disease off the we did the same in multiple myeloma. So we're very excited about the opportunities so that CAC 46.

In terms of up to 20 and.

[noise] summit covered it very well as well as for 80, we are.

Having an exact same thing from clinicians who have been using the drug on study. So certainly were seeing b cell modes work off to a maids inline portfolio, but I think the additional opportunity as a somewhat alluded to some about lifecycle management opportunities, where we then had the chance to move these treatments up earlier in the treatment sequence.

Samit Hirawat: The Bulletproof Executive, 2013

Samit Hirawat: As well as an improvement in the relapsed rate survival. And this is an oral agent, so convenience of delivery for these patients becomes very, very important.

Samit Hirawat: And this is the first and only treatment that has shown a survival benefit in the maintenance setting. So we remain excited about that, and we're looking forward to discussions with the authority and the filings going forward. Of course, here we also continue to think about the overall life cycle management plan with our portfolio and the combinations that could be available in the future. As it comes to CellMods, and then I will pass it on to Nadeem to comment more on, I think CellMods are certainly a very, very exciting addition to the overall portfolio and to the arsenal that we look forward to developing in multiple myelomas. So, we have additional plans for not only CC220 but CC480, which is another CellMod looking at multiple myeloma, and there are a multitude of opportunities with our overall portfolio of cell therapies, as well as the T-cell engagers, where we will continue to think about how to do treatments for further improvement in the outcome of these patients where the cure still does not exist. So, we will be sharing those plans in the coming months Let me pass it on to Nadeem to talk a little bit more.

But this place the image. So we're very excited about that opportunity also.

Thanks, Seamus for the questions can we go to the next question. Please.

Thank you next question comes from Chesney Kim from Bank of America. Please go ahead.

Good morning, everyone Ah Thanks to the question or just have a couple.

For David for Giovanni for 21, 2021 guidance I know you guys I want to give details, but generally issue should we assume the earnings growth will be mostly from.

The returned to growth for Io and maybe new launches or is it more from the operational synergy side of things.

And then from the Dean.

With.

What does a crowded field for BC and they targeted therapies, just curious about the status of moving.

20, 121 up to second line myeloma, and when you got guys thing about the BC and modalities in your pipeline.

How do you all reconcile bi specifics with parties in others. Thank you.

Yeah. Thank you, Jeff let me.

Obviously, when you look at 20 121 as Weve a as we've said we have an opportunity to return.

Got to growth sort of de though we have a number of really exciting loan opportunities and I've mentioned several of those and so there is real momentum into business.

Which is driven by the portfolio and how a new launches coming to play. That's the reason why I feel really good about the fact that <unk> you know difference to the guidance. We provided from plus 21 or is that even by dynamics in the portfolio that are very encouraging for us. So of course, we would read this.

Certainly and.

Nadim Ahmed: Thanks for listening.

With respect to continuing to execute on the synergies and as you know we've updated that we feel comfortable with the 2.5 billion about a third will come this year and we expect about a third that took him next year, but I think.

Nadim Ahmed: And then Thank you for the question, Seamus.

Nadim Ahmed: If you think about frontline or newly diagnosed AML across EU5 and the U.S., about 33,000 patients, and about two-thirds of those patients are eligible for intensive chemotherapy. That's the patient group that we studied. And the unmet need, even in newly diagnosed AML, is very high. So with the elderly patients, you have a five-year survival of only about 15%.

The growth of next year would have either.

I just about the portfolio opportunities are playing out let me just ask a summit and and and I deem to ask at once your second question. Thank you Ryan Thanks, Jeff for the question on the B C. A main portfolio. So from a b C M. A carts perspective from either so.

Nadim Ahmed: And 80% of these patients will relapse within 18 months. So to have a treatment that adds 10 months to overall survival and doubles relapse-free survival is going to be really important. So we're very excited about the opportunity in AML, and I'll also remind you that this gives us another opportunity to once again establish the maintenance treatment paradigm in another disease after we did the same in multiple myeloma. So we're very excited about the opportunity. So that's CC486. In terms of 220 and, Summit covered it very well, as well as 480.

We've already shared some of the data last year at Ash looking at I'd said in the fourth line plus patient population, where we saw a CR rate of 31% overall and we certainly excited towards.

The continuing to expand that portfolio and towards filing of that data set itself. There are three additional to.

Studies that are currently ongoing as you can see on [noise].

I'm trying to go Karma two is the study I think that sort of answered. Your question that we are beginning to look at the second line setting. So we're looking at a using tied to so in the second line patient population Karma three is a randomized phase three study looking at I just felt versus a trip.

Nadim Ahmed: We are hearing the exact same thing from clinicians who have been using the drug in studies. So certainly, we're seeing the cell mods work after our inline portfolio. But I think the additional opportunity, as Samit alluded to, is some of our lifecycle management opportunities where we then have the chance to move these treatments up earlier in the treatment sequence to displace the image. So we're very excited about that opportunity also.

The therapy for patients a third line plus setting and then Karma for was just initiated at the end of last year looking out into first line patient population in a phase one two studies. So we're really excited towards looking into the outcome to these studies in the data generation.

And when we talk about the overall portfolio from.

Giovanni Caforio: Thanks, Seamus, for the questions. Can we go to the next question, please, Anna?

I'm a b C. I may perspective, I think all the emerging data tells us that bcm is absolutely an important target that we need to be able to target a attack from various modalities, whether it'd be too the cell therapies that we talked about or the T cell engager that'd be have now I shared the data from the.

Operator: Thank you. The next question comes from Geoff Meacham from Bank of America. Please go ahead.

Geoff Meacham: Morning, everyone. Thanks for the questions. I just have a couple.

Geoff Meacham: For David or for Giovanni, for 2021 guidance, I know you guys don't want to give details, but generally, should we assume that earnings growth will be mostly from the return to growth for I.O. and maybe new launches or

Phase one study to six nine and certainly looking forward to now looking at how to bring that forward as more data matures and accelerated that development plan and then of course real look into our pipeline how to combine these with as we previously discussed with settlements et cetera, but let me pass it onto the deem to you.

Geoff Meacham: Operational Synergy side of things.

Geoff Meacham: thing. And then for Nadeem. With what is a crowded field for BCNA targeted therapy, I was just curious about the status of moving EB2121 up to second line myeloma. And when you guys think about the BCN modalities in your pipeline, how do you all reconcile bi specifics with CAR T's and

Give you a little bit more on that show. Thanks. Thanks commitments. So one thing I will remind everyone is that once we had a good idea that BC may was going to be a very important target for multiple myeloma, we strategically and proactively embarked on a multi modality approach to treating this.

Geoff Meacham: and others. Thank you.

Giovanni Caforio: Thank you, Geoff. Let me start. Obviously, when you look at 2121, as we've said, we have an opportunity to return to growth for Avdivo. We have a number of really exciting launch opportunities, and I've mentioned several of those, and so there is real momentum in the business, which is driven by the portfolio and how new launches come into play. That's the reason why I feel really good about the fact that the guidance we provided for 21 is driven by dynamics in the portfolio that are very encouraging for us. Of course, we will be disciplined with respect to continuing to execute on the synergies, and as you know, we updated that we feel comfortable with the $2.5 billion. About a third will come this year, and we expect about a third to come next year, but I think the growth for next year is really exciting about the portfolio opportunities playing out. Let me just ask Samit and Nadeem to answer your second question.

Disease.

And I'm thinking there was that you have very different patient segments that can benefit from coffee listed the T cell engager uneven 80 C, which we have early on in the clinic. So.

As you think about the various patient segments patient profiles on patient preference is you can envisage.

A patient has the opportunity to receive called team with a once one and done treatment that allows them to have very long treatment free interval. So there's an opportunity to do that physicians may choose to eat or refer the younger fit a patients for coffee. For example, you might have somebody who profess to be treated closer to home for whom.

The T cell engager will be an ideal treatment and then both treatments what definitely for T cell engager need to continue the treatment to stay on top of the disease and with the car T therapy. It's a one some done treatment. So we think there's definitely route.

Both and even potentially three modalities to coexist.

One within the same monotherapy.

But of course, okay. So across multiple lines of therapy in exactly the same way, we approached revlimid and pomalyst in the multiple myeloma market. So we feel very confident that were actually delivering on our strategy on the opportunity for multiple patient segments to benefit from all these tough so modalities.

Samit Hirawat: Thank you, Giovanni, and thanks, Geoff, for the question on the BCMA portfolio. So from a BCMA CAR-T cell perspective, from an IDA cell perspective, we've already shared some of the data last year at ASH, looking at IDA cells in the fourth-line plus patient population where we saw a CR rate of 31% overall, and we're certainly excited towards continuing to expand that portfolio and towards filing that data set itself There are three additional studies that are currently ongoing, as you can see on clintrails.gov. CARMA 2 is the study, I think, that sort of answers your question about whether we are beginning to look at the second-line setting. So we're looking at using IDA cell in the second-line patient population. CARMA 3 is a randomized phase 3 study looking at IDA cell versus triple therapy for patients in the third-line plus setting.

Great. Thanks Anna.

Can we go to the next question please.

Next question comes from Tim Anderson from one please Sir please go ahead.

Thank you couple of questions.

Originally you guys at the time of the deal gave 2022 and 2025 guidance on revenues and net income.

Hum.

That has not been updated since the IPO Tesla divestiture.

I'm wondering are you going to update that at some point or can you update that today.

Yes, it will have changed.

And then second question is at least for US a black box has been how to model rather.

Implement erosion at the time of the deal you made a very clear that your internal forecasts were much more conservative and cautious on the rate of erosion of Revlimid from 20 to 22 on words, which was a big product I'm wondering now a year on as you see analysts' models.

Samit Hirawat: And then CARMA 4 was just initiated at the end of last year, looking at the first-line patient population in a phase 1-2 study. So we're really excited about looking into the outcomes of these studies and the data generated. When we talk about the overall portfolio from a BCMA perspective, I think all the emerging data tells us that BCMA is absolutely an important target that we need to be able to attack from various modalities, whether it be through the cell therapies that we talked about or the T cell engager that we have now shared the data from the phase one study 269, and certainly looking forward to now looking at how to bring that forward as more data matures and accelerate that development Let me pass it on to Nadeem to give you a little bit more on that.

Do you think the analyst community is appropriately modeling that erosion. Thank you.

Thank you Tim Let me just a stat on both questions and then David can add more comments. So first of all with respect to.

Our guidance I think as we as we said from the from the beginning we were not going to go back.

Ken and update the D S four from last year.

As you know there had been.

A number of things that happened since last year, the divestiture over the past unless you mentioned.

The divestiture of.

Our second Super medicines business.

And on the other side continue to really.

Strong performance without were in line business and significant progress with the pipeline, which obviously.

He is a key driver of Ah Ah our performance in the next few years. So overall as I mentioned also my remarks, I feel better today about where we are a than I felt a year ago.

Samit Hirawat: Sure. Thanks, Samit.

Nadim Ahmed: And so one thing I will remind everyone is that once we had a good idea that BCMA was going to be a very important target for multiple myeloma, we strategically and proactively embarked on a multi-modality approach to treating it. And our thinking there was that you have very different patient segments that can benefit from CAR-T versus a T cell engage, and even ADC, which we have early on in the clinic. So as you think about the various patient segments, patient profiles, and patient preferences, you can imagine where a patient has the opportunity to receive CAR-T with a once-one-and-done treatment that allows them to have a very long treatment-free interval. So there's an opportunity to do that. Physicians may choose to refer their younger and fitter patients for CAR-T, for example.

So when we first a announced the deal.

And ER and the strength of online business and and the progress made with our pipeline make me feel really good about the future and and the key drivers.

There were behind a set up the the.

Since we had last year and we have today.

In the business today, we provided guidance on 2020 and 21 I made some comments.

About our perspective on 22.

And we feel pretty good about where we are so now with respect to with respect to revlimid.

Also there are there have been good developments.

First of all I would say being line performance of the brand continues to be strong and the teams are doing a great job continuing to support a an important franchise I think thats important we had to wipe yards decisions which were favorable.

Nadim Ahmed: You may have somebody who prefers to be treated closer to home, for whom a T cell engager will be an ideal treatment, but then both treatments work differently. For a T cell engager, you need to continue the treatment to stay on top of the disease, and with CAR-T therapy, it's a once-and-done treatment. So we think there's definitely room for both, and even potentially three, modalities to coexist, one within the same line of therapy but also across multiple lines of therapy, in exactly the same way we approached Revlimid and Pomalyst in the multiple myeloma market. So we feel very confident that we're actually delivering on our strategy, and there's the opportunity for multiple patient segments to benefit from all these types of modalities.

ER to Bristol Myers Squibb, we'd need to reach a settlement with Allergan, which was aligned with that with our expectations and I would say that overall, we continue to see the loss of exclusivity for revlimid or as a as the slope that is driven by.

Sort of all of the same assumptions that we discussed in the past that has been good development.

And and so nothing has really changed the there.

Great and thanks for the questions and it can we go to the next one please.

Your next question comes from parents thin from Goldman Sachs.

Sacks. Please go ahead.

Hi, good morning, Thanks for taking the questions.

Nadim Ahmed: Great, thanks. And can we go to the next question?

Was wondering first on Opdivo, if you can give us your latest thoughts on the opportunity in had you been bladder following the Roche due to just wondering if there any notable trial design differences you could 0.2 for your study versus their trial and then on B B 20 120.

Operator: The next question comes from Tim Anderson from Wolf Research. Please go ahead.

Tim Anderson: Thank you. I have a couple of questions.

Tim Anderson: Originally, you guys at the time of the deal gave 2022 and 2025 guidance on revenues and net income. That has not been updated since the Tesla infrastructure. And I'm wondering if you are going to update that at some point? Or can you update that today? I guess we'll have changed. And then the second question is, at least for us, a black box has been how to model Revlimid erosion. At the time of the deal, you made it very clear that your internal forecasts were much more conservative and cautious about the rate of erosion of Revlimid from 2022 onwards, which is a big product.

And Jay car and their commercial ramp on the forward anything you guys have learned from a competitive car T launches that you can leverage and would you expect to have stronger launches as a result, thank you.

Thanks, Terence somebody why don't you start and I'm sure.

Thank you for the question turns and as it relates to.

The AD doing setting for so let me start by saying that immuno oncology products are going to play a major rule in the I do in setting because the earlier you can utilize these treatments it will provide an opportunity to not only shift the level of occurrence, but provide a potential for cure for these patients and overall.

Tim Anderson: I'm wondering now, year on, as you see analyst models. Do you think the analyst community is appropriately modeling data erosion?

As we move earlier and earlier.

We are from the metastatic setting to the earlier setting the overall plan that we haven't place here, we feel very confident about it in non small cell lung cancer melanoma, RCC gastric and of course in bladder cancer as well.

Tim Anderson: Thank you.

Giovanni Caforio: Thank you, Tim. Let me just start on both questions, and then David can add more comments. So first of all, with respect to guidance, I think, as we said from the beginning, we're not going to go back and update the S4 from last year. As you know, there have been a number of things that have happened since last year, the divestiture of the Tesla, as you mentioned, the divestiture of our OOPSA consumer medicines business, and on the other side, continued really strong performance with our inline business and significant progress with So overall, as I mentioned in my remarks, I feel better today about where we are than I did a year ago when we first announced the deal, and the strength of our inline business and the progress made with our pipeline make me feel really good about the future and the key drivers that were behind the confidence we had last year and we have today in the business.

There is no point trying to do cross drive comparisons at this point I think we're pretty close to where we will be starting to see the data.

Urging I think just to just to keep in mind that the.

Overall patient population that weve enrolled seems very similar and without getting into the specifics. The one major differences placebo used in our trial versus.

Observation and the other trial and the treatment duration is different about I think we should wait for.

The data for it to read out rather than getting into the specifics at this time, but I think.

Chris can you can give you a more color on the commercial side, yes. So let me just say something on a macro level with respect to the agile in programs and then I'll talk specifically about bladder just a reminder, that as you think about the adjuvant setting you need to think not only about the patients who were treated today.

Yeah, but also the potential for patients to be treated.

So what we saw when we launched Io in the advent melanoma space was that you sell treatment rates and increased significantly and in a number of the tumors in which we are pursuing or early stage program you see treatment rates in the low to.

Giovanni Caforio: Today, we provided guidance for 2020 and 2021. I made some comments about our perspective on 2022, and we feel pretty good about where we are. Now, with respect to Revlimid, there have also been good developments. First of all, I would say the inline performance of the brand continues to be strong, and the teams are doing a great job continuing to support an important franchise. I think that's important.

Single.

[noise] Olson currently up to potentially around 40% for some tumors, but still there's plenty of opportunity for us to not only treat patients who are being treated today, but with improved therapies improve the treatment rates overall with respect to bladder cancer. Specifically this is a very large patient population, it's highly fragmented and we have importantly.

A couple opportunities in the muscle invasive space about 50% of those patients are getting surgery. Today, we have techniques 78, which is in the Perry adjutant setting a we're looking at the entire population with Checkmate 274, and we also have a non muscle invasive bladder program as well so.

Giovanni Caforio: We had two IPR decisions that were favorable to Bristol Myers Squibb. We did reach a settlement with Alvergen, which was aligned with our expectations, and I would say that overall, we continue to see the loss of exclusivity for Revlimid as a slope that is driven by all the same assumptions that we've discussed in the past. There have been good developments, and nothing has really changed.

It's an important opportunity for us we.

Are still very competent in the opportunity for Io and the ajit been setting and we very much look forward to seem the data.

Giovanni Caforio: Great. Tim, thanks for the questions. Anna, can we go to the next one, please?

Operator: The next question comes from Terence Flynn from Goldman Sachs. Please go ahead.

Right. Thanks, Chris will pick up on on call today. So I think a couple of things I would mention as you alluded to so clearly there have been some headwinds in the marketplace and I think about things like.

Terence C. Flynn: Hi, good morning. Thanks for taking the questions. I was wondering first on OpDivo if you could give us your latest thoughts on the opportunity in adjuvant bladder following the Roche data. Also, wondering if there are any notable trial design differences you could point to for your study versus theirs. And then on BB2121 and JCAR and the commercial ramp on the forward, anything you guys have learned from the competitive CAR T launches that you can leverage, and would you expect to have stronger launches as a result? Thank you. Thanks.

Reimbursement accessing.

Ireland complexity of manufacturing also you know the safety profile current agents has led to most of the administration being conducted in the inpatient setting so were addressing all of those near term headwinds I'm sorry couple of things I would say so if I use.

Just like that so as an example, the dates we showed.

I should the pivotal data, we're seeing a safety profile, where we're seeing significant reduction in the incidence and severity of Crs Neurotech toxicity, which we think bodes well to be able to give this treatment in the outpatient setting which will allow us to expand out prescriber base I'm. So excited about that the other thing that's important to point out from a.

Terence C. Flynn: Thanks, Terence. Samit, why don't you start? Sure. Thank you.

Samit Hirawat: Thank you for the question, Terence.

Samit Hirawat: to the adjuvant setting. First of all, let me start by saying that immuno-oncology products are going to play a major role in the adjuvant setting because the earlier we can utilize these treatments, it will provide an opportunity to not only shift the level of recurrence but provide a potential for cure for these patients. And overall, as we move earlier and earlier from the metastatic setting to the earlier setting, the overall plan that we have in place, we feel very confident about it in non-small cell lung cancer, melanoma, RCC, gastric, and of course, in bladder cancer as well. There's no point trying to do cross-trial comparisons at this point. I think we are pretty close to where we will be starting to see the data emerging.

[noise] differentiate shouldn't have BMS is that we do have very deep relationships with hematology and that includes multiple myeloma that includes lymphoma. So our footprint out in the community will really help us a drug to drive those referrals into the treatment sites with qualities will be given as well as expand out into.

The community with assets like myself, so from where we're looking we think we're addressing them at some headwinds.

Some of that the access environment ongoing work continues in terms of addressing the DRG issue.

Great News last year that the national coverage determination wasn't implemented so that could have.

Samit Hirawat: I think just to keep in mind that the overall patient population that we've enrolled seems very similar, and without getting into the specifics, the one major difference is the placebo used in our trial versus observation in the other trial, and the treatment duration is different. But I think we should wait for the data to read out rather than get into the specifics at this time. But I think Chris can give you more color on the commercial side.

Good site of care. So that's not an issue for US now from a manufacturing capacity capability between summit on Seattle, We feel very good about capacity at launch and we also have longer term plans to expand that footprint to make sure. We continue to have a great capacity, but the other final thing I would add is we've seen transformational data in very late.

State setting, but I think the true potential these therapies, it's moving them up earlier in the treatment sequence from a long term potential perspective, and you hook them summit that we have a very aggressive lifecycle management plan for both of these assets that will allow us to unlock the that long term potential for these transformational therapies.

Chris Boerner: Yeah, so let me just say something at a macro level with respect to the adjuvant programs and then I'll talk specifically about bladder. Just a reminder that as you think about the adjuvant setting, you need to think not only about the patients who are treated today, but also the potential for patients to be treated. So what we saw when we launched IO in the adjuvant melanoma space was that you saw treatment rates increase significantly, and then a number of the tumors in which we are pursuing our early stage program, you see treatment rates in the low to single digits, ultimately up to potentially around 40% for some tumors, but still there's plenty of opportunity for us to not only treat patients who are being treated today, but with improved therapies, improve the treatment rates overall.

Thanks Utterance can we go to.

The next question please.

Your next question comes from my pipe from William Blair. Please go ahead.

And then my question I was wondering if you could quantify the impact of buying pattern for opdivo in the U.S. for the quarter or do we just assume it's the difference between the 6% decline and core.

Quarter over quarter prices first as I mentioned to.

No single digit declined to demand.

Yes, Matt Chris Yeah, So let me let me.

Address that Matt So as David mentioned in his prepared remarks, we saw gevo decline on the quarter versus same time last year about 2% and let me just characterize that that was in.

Tirelessly driven by the U.S., which was down about 10%, but virtually all of that decline year over year. As a result of the dynamics, we've been talking about quite a bit which are the dynamics in second line lung cancer. As you look on a sequential basis. The U.S. was down roughly 6% about half of that.

Chris Boerner: With respect to bladder cancer specifically, this is a very large patient population. It's highly fragmented, and we have, importantly, multiple opportunities. In the muscle invasive space, about 50% of those patients are getting surgery today. We have CHECKMATE 78, which is in the periadjuvant setting. We're looking at the entire population with CHECKMATE 274 and we also have a non-muscle invasive bladder program as well. So it's an important opportunity for us. We are still very confident in the opportunity for IO in the adjuvant setting, and we very much look forward to seeing the data.

That was a result of.

The inventory work down with the VA. The remaining portion of that was mainly the second line eligibility issue in lung cancer, we saw a little bit of an impact in eligibility in small cell lung cancer in head and neck, but importantly, if you normalize for the VA.

Inventory movements, what you see in both Q3 in Q4 from a demand standpoint was up vivo was down as David mentioned in low single digits around 2% to 3%.

And importantly, as we see.

Nadim Ahmed: Great, thanks Chris. So I'll pick up on CAR T. So I think a couple of things I would mention, as you alluded to. So clearly, there have been some headwinds in the marketplace, and I think about things like the reimbursement access environment, the complexity of manufacturing, and also, you know, the safety profile of current agents has led to most of the administration being conducted in the inpatient setting. So we're addressing all of those near-term headwinds. So there are a couple of things I would say.

Both 2020 and 2021 the impacts that you saw in the quarter will have no material impact on.

We see for the year as a whole in 2020 and for the growth opportunities for Opdivo as we go into 21.

The next question. Please now.

Your next question.

From Steve Scala from Cowen. Please go ahead.

Thank you I have two questions both for clarification.

Jason first Giovanni to clarify on what you said about growth in 2022 did you say you see growth into 2022 or through 2022, although moderating and if into is there any scenario where earnings would be down in 2022. So that's the first.

Nadim Ahmed: So if I use just Lysosil as an example, the data we show, the ashes of the pivotal data, we're seeing a safety profile where we've seen a significant reduction in the incidence and severity of CRS neurotoxicity, which we think bodes well to be able to give this treatment in the outpatient setting, which will allow us to expand our prescriber base. So we're excited about that. The other thing that's important to point out from a differentiation of BMS is that we do have very deep relationships with hematologists, and that includes multiple myeloma, and that includes lymphoma.

Question.

Second one is on the other income expense guidance for 2020.

It appears that way better than one would expect given the financing costs. Now you mentioned this step up in royalties on Keytruda and the Astra Zeneca diabetes products in 2020, but I thought.

I thought that the Keytruda royalty was flat at 6.5% through 24, and the Astra Zeneca royalties are either flat.

Nadim Ahmed: So our footprint out in the community will really help us to drive those referrals into the treatment sites where CAR T's will be given as well as expand out into the community with assets like Lysosil. So from where we're looking, we think we're addressing the near-term headwinds. In terms of the access environment, ongoing work continues in terms of addressing the DRG issue. Great news last year that the national coverage determination wasn't implemented, so that could have impacted the side of care, so that's not an issue for us now. From a manufacturing capacity capability standpoint between Summit and Seattle, we feel very good about the capacity at launch, and we also have longer-term plans to expand that footprint to make sure we continue to have great capacity.

Or step down in 2020.

So are you, saying that the royalty rates are the same but the products will grow or something different.

And I don't think Theres, a lot of optimism about the Astra zeneca diabetes portfolio. So so I'm wondering again is that the royalty rates are changing or the products.

Royalties are changing so please clarify thank you.

Thank you Steve Let me ask let me answer the first question. So when I spoke about 2022.

I'm speaking about good growth in 2022 or more that aided by a in terms of the growth rate and by the potential beginning of the entrance of.

Generics put revlimid in 2022, so I see gross.

This point.

Our business growing in 2022, as a year or with a with a moderation of the growth rate versus 21, driven by the dynamic I just discussed David.

Nadim Ahmed: The other final thing I would add is we've seen transformational data in very late stage settings, but I think the true potential of these therapies is moving them up earlier in the treatment sequence from a long-term potential perspective, and you heard from Summit that we have a very aggressive life cycle management plan for both of these assets that will allow us to unlock that long-term potential for these transformational therapies. Thanks, Terence.

And can trued up from a volume perspective continues to grow and Astra zeneca the rate continues to increase.

That.

As being offset by the higher interest expenses I talked about my prepared remarks, with a $45 billion at that and average interest rate of 3.4%.

Hey can we go to that I think we have time, maybe for two more questions Ana.

Thank you next question comes from David Risinger.

Morgan Stanley. Please go ahead.

Thanks, very much and congrats on a on the disclosures. So started to go back on this Giovanni but just a quick question I think that last year you had said.

Giovanni Caforio: Thanks, Terence. Can we go to the next question, please, Anna?

We expect to grow.

Operator: The next question comes from Matt Pipes from William Blair. Please go ahead.

The growth bps through 2025 in your prepared remarks, you bet should.

Matt Pipes: That's been my question. I was wondering if you could quantify the impact of buying patterns for Opdivo in the US for the quarter, or do we just assume it's the difference between the 6% decline and quarter and quarter over quarter prices versus, I know you mentioned a low single-digit decline.

Huh.

Genuine growth.

Into 2022 could you just provide any comments beyond 2022. Please.

And then second with respect to car T hospitals are.

Obviously, losing significant amount of money.

On patients who are not in clinical trials, which are paid for by manufacturers could you just talk about prospects for changes to Medicare reimbursements and Oh potential.

Chris Boerner: Chris? Yeah, so let me address that, Matt. So, as David mentioned in his prepared remarks, we saw a Devo decline in the quarter versus the same time last year, about 2%. And let me just characterize that. That was entirely driven by the US, which was down about 10%. But virtually all of that decline year over year is a result of the dynamics we've been talking about quite a bit, which are the dynamics of second-line lung cancer. As you look on a sequential basis, the US was down roughly 6%.

Ranges and DRG codes in the future. Thanks, so much.

Sure David Let me start and then on Ethernet Nadeam World up we'll call them until let me just to.

Hey, again, I feel really good about what we are with our business we are discussed.

Clearly in Q3, we would not update the S four going forward.

Chris Boerner: About half of that was a result of the inventory work-down with the VA. The remaining portion of that was mainly the second-line eligibility issue in lung cancer. We saw a little bit of an impact in eligibility for small cell lung cancer in the head and neck. But importantly, if you normalize for the VA inventory movements, what you see in both Q3 and Q4 from a demand standpoint was up, and Devo was down. As David mentioned, in low single digits, around 2% to 3%. And importantly, as we see in both 2020 and 2021, the impacts that you saw in the quarter will have no material impact on what we see for the year as a whole in 2020. And for the growth opportunities for Avdiva as we go into 2020. Do you have the next question, please, Ann?

And I'm I'm feeling pretty good about having provided.

Visibility into the next three years.

Which clearly demonstrate the earnings by what are the growth outlook for the company most importantly.

I.

Really good about the.

Fundamentals of the business both in terms of the performance of the line portfolio in the speed at which are the pipeline that will drive the long term growth of the company's advancing so.

I'm not going to make comments beyond 2022.

But I believe I provided Mike Mike.

Perspective on where we are as a company and the real opportunity we have for the long term that im.

Sure. Thanks, Thanks for the question so I think.

Part of the issue around the access reimbursement environment has as I said previously has been driven a lot by the fact.

Chris Boerner: The next question comes from Steve Scala from Cowen. Please go ahead.

Many of these treatments have been given indeed inpatient setting. So one I would say if you have a treatment that has the potential to be utilizing the outpatient setting then you start entering into the public environment, which is very different to the inpatient capitated DRG environments. That's one point I would like especially as it pertains to license so I think in the.

Steve Scala: Thank you. I have two questions, both for clarification. First, Giovanni, to clarify what you said about growth in 2022. Did you say you see growth into 2022 or through 2022, although moderating? And if through, is there any scenario where earnings would be down in 2022? So that's the first question.

Inpatient setting the challenge has exactly being that the of the Capitated a treatment.

Steve Scala: And the second one is on the other income expense guidance for 2020; it appears way better than one would expect given the financing costs. Now you mentioned the step up in royalties on Keytruda and the AstraZeneca diabetes products in 2020. But I thought I thought that the Keytruda royalty was flat at 6.5% through 24 and the AstraZeneca royalties are either flat at or will step down in 2020. So are you saying that the royalty rates are the same, that the products will grow, or something different? And I don't think there's a lot of optimism about the AstraZeneca diabetes portfolio. So, I'm wondering, again, whether it is the royalty rates that are changing or the products. Royalties are changing, so please clarify. Thank you.

Even having said that those things have started to improve we sold the ends have improved to 65% last year through CMS I think there's been lots of token we've been working on a potential DRG because he specifically currently sites.

Having to use the DRG to stem cell transplant, which under reimburses the cost of car T therapy. So there is work to do but the two things I would leave you wave is outpatient represents a discrete different opportunity, which isn't affected by capitated paid payments, but at the same time I think CMS is working on the opportunity to come up with.

They specific DRG potentially full coffee and I think that will help reimbursement in the inpatient setting also.

Thanks, Dave can we go to our last question. Please Ana.

We take our next question from leaving Jacobson UBI. Please go ahead.

Hi, this is broken up in <unk>.

On behalf of smoking. So my first question is on a particular middle for Htwo trial. There was some interesting data at ASCO Gi I recently, and first laying out to see for Opdivo Kabul on the Opdivo cobble together, what triplet regimen. So any comments on the data presented.

Giovanni Caforio: Thank you, Steve. Let me ask you something, let me answer the first question. So when I spoke about 2022, I was speaking about growth in 2022, moderated by, in terms of the growth rate, by the potential beginning of the entrance of generics for Revlimid in 2022. So I see, you know, at this point, our business growing in 2022, as a year, with a moderation of the growth rate versus 21, driven by the dynamic David

And a potential for Easter.

And then if you see.

And second question is on your line. So you don't work performed better than expectations this quarter.

So the question is impact from the uptake off.

No enlighten regimen is unfortunately, obviously see mostly done and or should we expect more temporary notion in U.S. and joint or any thank you.

David V. Elkins: Yeah, and Contruda, from a volume perspective, continues to grow, and AstraZeneca, the rate continues to increase. So that is being offset by the higher interest expenses I talked about in my prepared remarks, with the $45 billion of debt and an average interest rate of 3.4%.

Summit for them just tied up in the H.C.C. Arena. Our focuses primarily on the of de Vore Yervoy combination so beyond that you're not be looking to any expended.

Looking at this time, so that's all I can share this thing from HCC perspective, but.

David V. Elkins: Okay, can we go to the I think we have time maybe for two more questions, Anna.

Maybe Chris Chris Yeah, So Uruguay for the quarter was flat relative to the same time last year, and we did show sequential growth of around 9% versus the third quarter or 2019.

Operator: Thank you. The next question comes from David Risinger from Morgan Stanley. Please go ahead.

David R. Risinger: Thanks very much and congrats on the disclosures. So, sorry to go back on this, Giovanni, but just a quick question.

And that growth was driven really by on both the.

David R. Risinger: I think that last year you said you expected Bristol to grow EPS through 2025. In your prepared remarks, you mentioned continuing growth into 2022. Could you just provide any comments beyond 2022, please? And then second, with respect to CAR T, hospitals are obviously losing a significant amount of money on patients who are not in clinical trials, which are paid for by manufacturers. Could you just talk about prospects for changes to Medicare reimbursement and potential changes in DRG codes in the future? Thanks so much.

The U.S.

As well as in X U.S. on we saw a bit of an uptick in new use about debo, plus Uruguay really across multiple tumors and the remainder of the business, where we have opdivo plus yervoy in the market today as well as they use of Yervoy as a monotherapy in a selected.

Number of indications was relatively stable for the quarter. So on what we're really starting to see is on the increased use of opdivo, plus yervoy really spread across multiple tumors and that's happening both in the U.S. and to a lesser extent outside of view us.

Giovanni Caforio: Thanks so much. David, let me start, and then Nadim will comment.

Giovanni Caforio: Let me just say again, I feel really good about where we are with our business. We discussed very clearly in Q3 that we would not update the S4 going forward. I feel pretty good about having provided visibility into the next three years, which clearly demonstrates the earnings power and growth outlook for the company. Most importantly, I feel really good about the fundamentals of the business, both in terms of the performance of the online portfolio and the speed at which the pipeline that will drive the long-term growth of the company is advancing. So, I'm not going to make comments beyond 2022, but I believe I have provided my perspective on where we are as a company and the real opportunity we have for the long term. Nadim

Thank you thank you Chris and thanks.

Anyone so before we close.

I would like to thank John Elicker for extraordinary leadership of I out over many many years. Thank you John.

Now even closing we've had a very successful 2019 and I'm proud.

Of the focus that our teams have had to go out of.

Very very busy year, we advanced our pipeline, we delivered strong commercial execution to make a difference in the lives of patients and we are very well positioned as we embark on our next chapter as a new company. Thanks, everyone.

Thanks, everybody for taking the time as always if you have any follow ups give us.

Call.

Ladies and gentlemen. This concludes today's conference call. Thank you feel participation you may now disconnect.

Nadim Ahmed: Sure, thanks for the question. So I think part of the issue around the access reimbursement environment has, as I said previously, been driven a lot by the fact that many of these treatments have been given in the inpatient setting. So one point I would make is that if you have a treatment that has the potential to be utilized in the outpatient setting, then you start entering into the Part B environment, which is very different from the inpatient capitated DRG environment. So that's one point I would make, especially as it pertains to lysosol. I think in the inpatient setting, the challenge has exactly been that, capitated treatment. Even having said that, those things have started to improve.

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Nadim Ahmed: We saw the NTAP improve to 65% last year through CMS. I think there's been lots of talk, and we've been working on a potential DRG for CAR-T specifically. Currently, sites are having to use the DRG for stem cell transplants, which under-reimburses the cost of CAR-T therapy. So there is work to do, but the two things I would leave you with are that outpatient represents a discrete different opportunity, which isn't affected by capitated payment. But at the same time, I think CMS is working on the opportunity to come up with a specific DRG potentially for CAR-T, and I think that will help reimbursement in the inpatient setting also.

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Nadim Ahmed: Thanks, Dave. Can we go to our last question, please, Anna?

Operator: We take our next question from Naveen Jacob from UBS. Please go ahead.

Naveen Jacob: Hi, this is Prakhar Agrawal on behalf of Naveen. So my first question is on the checkmate of the 412 trial. There was some interesting data at ASCO GI recently in first-line FTC for Obdivo-Cabo and Obdivo-Cabo-Yerwoye triplet regimens. So any comment on the data presented and potential for these two regiments in FTC? And the second question is on Yerwoye. So Yerwoye performed better than expected this quarter. So the question is, is the impact from the uptake of Ketura in the latter regimen in first-line RTC mostly done, and should we expect more tempered erosion in the US in 2020? Thank you.

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Samit Hirawat: Samit, why don't you start? In the HCC arena, our focus is primarily on the up-devo, year-voy combination, so beyond that, we're not really looking to any expanded way of looking at it at this time, so that's all I can share at this time from the HCC perspective, but maybe Chris, you first.

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Chris Boerner: Yeah, so Urovoi for the quarter was flat relative to the same time last year, but we did show sequential growth of around 9% versus the third quarter of 2019. And that growth was driven really by both the US and outside the US. We saw a bit of an uptick in the use of Avdevo plus Urovoi across multiple tumors, and the remainder of the business where we have Avdevo plus Urovoi in the market today, as well as the use of Urovoi as a monotherapy in a selected number of indications was relatively stable for the quarter. So what we're really starting to see is the increased use of Avdevo plus Urovoi really spread across multiple tumors, and that's happening both in the US and, to a lesser extent, outside of the US.

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Giovanni Caforio: Thank you. Thank you, Chris. And thanks, everyone. So, before we close, I would like to thank John Elicker for his extraordinary leadership of IR over many, many years. Thank you, John.

Giovanni Caforio: Now, in closing, we've had a very successful 2019, and I'm proud of the focus that our teams have had throughout a very, very busy year. We advanced our pipeline. We delivered strong commercial execution to make a difference in the lives of patients, and we are very well positioned as we embark on our next chapter as a new company. Thanks, everyone.

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John Elgar: Thank you everybody for taking the time. As always, if you have any follow-ups, give us a call. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation.

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Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. © BF-WATCH TV 2021, www.mytrendyphone.co.uk www.mytrendyphone.co.uk ??? ?? ?? ?? ?? ?? ?? ?? ?? ??

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