Q4 2020 Gilead Sciences Inc Earnings Call

Ladies and gentlemen, and thank you for standing by and welcome to the fourth quarter 2020, Gilead Sciences earnings Conference call. At this time all participants are in a listen only mode. After the speaker presentation that will be a question and answer session to ask a question. During this session you would need to press star one on your telephone.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the fourth quarter 2020 Gilead Sciences Earnings Conference Call. At this time, all participants are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press Star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your first speaker today, Andrew Ang, Senior Director of Investor Relations. Thank you. Thank you to them, and good afternoon, everyone.

Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero and I would not like to hand, the conference over to your first speaker today, Andrew and cause senior director of Investor Relations. Thank you. Please go ahead.

Thank you Dylan and good afternoon, everyone.

Operator: Just after the market closed today, we issued a press release with earnings results for the fourth quarter and full year 2020. The press release and detailed slides are available in the investor section of the Gilead website. The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer.

Just after the market closed today, we issued a press release with earnings results for the fourth quarter and full year 'twenty and 'twenty.

And the press release and detailed slides are available on the investors section.

And he had website.

The speakers on today's call will be Daniel O'day, Chairman and Chief Executive Officer, Johanna Mercier, Chief Commercial Officer, Mark I'd, Parsi, Chief Medical Officer, and Andrew Dickinson, Chief Financial Officer.

Andrew D. Dickinson: Johanna Mercier, Chief Commercial Officer; Merdad Parsey, Chief Medical Officer; and Andrew Dickinson, Chief Financial Officer. Also on the call and available for Q&A will be Chris, Chief Executive Officer of Before we begin with our prepared remarks, let me remind you that we will be making forward-looking statements, including risks and uncertainties related to the impact of the COVID-19 pandemic on Gilead's business, financial condition, and results of operations, plans, and expectations with respect to products, product candidates, corporate strategy, financial projections, and the use of capital. All of these involve certain assumptions, risks, and uncertainties that are beyond our control and can cause actual results to differ materially from these.

I also wanted to call and available for Q&A will be Christi, Shaw Chief Executive Officer, Okay.

Before we begin with our prepared remarks, let me remind you that we will be making forward looking statements Inc.

<unk> risks and uncertainties related to the impact of the COVID-19, pandemic and Gilead business financial condition and results of operations plans and expectations with respect to products product candidates corporate strategy and financial projections and the use of capital and 'twenty 'twenty, one financial guidance, all of which involve certain assumptions risks and uncertainties that will be.

And our control and could cause.

Actual results to differ materially from these statements.

A description of these risks can be found and the earnings press release, and our latest SEC disclosure documents and.

Andrew D. Dickinson: A description of these risks can be found in the earnings press release and our latest SEC Disclosure Document. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. Non-gap financial measures will be used to help you understand the company's underlying performance. Gap to non-gap reconciliations are provided in the earnings press release as well as on the Gilead website.

All forward looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward looking statements.

Non-GAAP financial measures will be used to help you understand the company's underlying business performance.

GAAP to non-GAAP reconciliations are provided and the earnings press release as well as on the Gilead website.

Daniel O'Day: I will now turn the call over to Andrew. Thank you, Andrew, and good afternoon, everyone. Thank you for joining us today. We're pleased to have this opportunity to provide an update on our progress and answer your questions. I'll begin by offering brief remarks and then hand off to the team to go into more detail. Before I begin, I want to thank all those who contributed to the progress we will highlight today, both our teams across the company and our many partners and collaborators worldwide. Let me start by looking back at the fourth quarter.

I'll now turn the call over to Dan.

Thank you Andrew and good afternoon, everyone and thank you for joining US today, we're pleased to have this opportunity to provide and update on our progress and answer your questions Paul.

I'll begin by offering brief remarks, and then hand off to the team to go into more detail.

Before I begin I want to thank all those who contributed to the progress we will highlight today.

Both of our teams across the company and our many partners and collaborators worldwide.

Let me start by looking back at the fourth quarter.

Daniel O'Day: Our work continued across three main areas, as it has throughout 2020: responding to the pandemic with our antiviral therapy, VicLurie; delivering on our commitment to people with HIV, cancer, viral hepatitis, and other conditions; and thirdly, executing on our strategy. As a result of our efforts to expand and strengthen our portfolio, we're going into 2021 in a very different position than how we began 2020. Last month, we provided updated guidance for the fourth quarter and full year 2020 to ensure that you had a clear picture coming into today's earnings.

Work continued across three main areas as it has throughout 'twenty and 'twenty responding to the pandemic with our anti viral therapy burglary and delivering on our commitment to people with HIV cancer viral hepatitis and other conditions and thirdly executing on our strategy.

As a result of our efforts to expand and strengthen our portfolio, we're going into 'twenty and 'twenty, one and a very different position to how we began 2020.

Last month, we provided updated guidance for the fourth quarter and full year 'twenty and 'twenty.

And to ensure that you had a clearer picture coming into today's earnings announcement.

Daniel O'Day: This updated guidance was largely based on the significant increase in the uptake of Eclurine. In the United States alone, hospitalizations quadrupled between October and January, and approximately one out of every two patients hospitalized in the U.S. are being treated with Clary today. We're grateful that Vicari is able to play such an important role in getting patients out of the hospital fast, five days on average, based on the NIAID Act 1 trial, especially as many parts of the world struggle with hospital capacity.

This updated guidance was largely based on the significant increase and the uptake about clearing.

And the United States alone Hospitalizations quadrupled between October and January and approximately one out of every two patients hospitalized and U S. R.

And are being treated with <unk> today.

We're grateful that recovery is able to play such an important role and getting patients out of the hospital faster five days on average based on the NII D Act, one trial, especially as many parts of the world struggle with hospital capacity.

The higher uptick a bit clearer along with the continued growth of our leading treatment for HIV book Tommy.

Daniel O'Day: The higher uptake of VicTLURI, along with the continued growth of our leading treatment for HIV, VicTAR, helps to offset the ongoing impact of the pandemic on some parts of our business. Fekluri and Bektarvi have also helped to mitigate the expected impact of loss of exclusivity for Atripla and Trivada in October. Our efforts to build out our portfolio of medicines continued in the fourth quarter with our agreement to acquire MIR. The acquisition, which is on track to close in the first quarter of this year, subject to regulatory clearances and other closing conditions, will bring us a first-in-class medicine called HEPCLUDIX for the treatment of hepatitis D or HDV.

Helped to offset the ongoing impact of the pandemic and some parts of our business.

But Gloria and Victoria V also helped to mitigate the expected impact of loss of exclusivity for a triple a and Truvada in October.

Our efforts to build out our portfolio of medicines continued in the fourth quarter with our agreement to acquire mirror.

The acquisition, which is on track to close and the first quarter of this year subject to regulatory clearances and other closing conditions will bring us a first in class medicine called <unk> for the treatment of hepatitis D. R. H D D.

Daniel O'Day: This is the most severe form of viral hepatitis and affects some patients who are already infected with hepatitis B. Hypoclutics is conditionally approved in Europe and has FDA breakthrough therapy designation as an investigational agent in the United States.

This is the most severe form of viral hepatitis and affect some patients who are already infected with hepatitis b.

<unk> is.

<unk> approved in Europe, and has FDA breakthrough therapy designation as an investigational agent and the United States.

The acquisition of Immunomedics closed and the fourth quarter, bringing the most significant recent addition to our pipeline for Delphi.

Daniel O'Day: The acquisition of Immunomedics closed in the fourth quarter, bringing the most recent significant addition to our pipeline, Tredelta. Codelve is a foundational medicine in our cancer portfolio with significant potential across multiple tumor types. We're very pleased with how the integration with Immunomedics is going and look forward to updating you on our progress with Trodelvia. Andy, Johanna, and Merdad will share more details in a quarter. I'd like to turn now to the year ahead.

<unk> as a foundational medicine, and our cancer portfolio with significant potential across multiple tumor types.

We're very pleased with how the integration with immunomedics is going and look forward to updating you on our progress with <unk>.

Andy Joanna and Mehrdad will share more detail on the quarter I'd like to turn now to the year ahead.

The first thing I would say is that we're moving forward with a clear path to growth.

Daniel O'Day: The first thing I would say is that we're moving forward with a clear path to growth. We have multiple opportunities in new therapeutic areas, especially in college. We're very pleased with the strong and diverse oncology portfolio we have today. This portfolio consists of both marketed therapies, such as Tredelvi and Tocardis and Yerskarta from KITE, and programs across various stages of the pipeline. There are currently 27 internal ongoing clinical stage programs for hematologic malignancies and solid tumors. We also have many promising opt-in options. One of those options is the anti-TIGIT program through our collaboration with Arcus Files.

We have multiple opportunities and new therapeutic areas, especially oncology.

We're very pleased with the strong and diverse oncology portfolio, we have today.

This portfolio consists of both marketed therapies, such as <unk> and took hardest and U S. Carter from kite and programs across various stages of the pipeline.

There are currently 27 internal ongoing clinical stage programs for hematologic malignancies and solid tumors.

We also have many promising opt in opportunities one of those options for the anti tissue program through our collaboration with ARCUS Biosciences.

Earlier this week it was announced that we are increasing our investment and ARCUS to help fund the continued progress of the promising ARCUS pipeline.

Daniel O'Day: Earlier this week, it was announced that we are increasing our investment in ARCIS to help fund the continued progress of the promising ARCIS pipeline. The foundation for our near and long-term growth is our continued leadership in antivirals. We are confident in the longevity of our HIV.

The foundation for our near and long term growth is our continued leadership and anti Virals.

We are confident and the longevity of our HIV business.

Daniel O'Day: We expect Big Tar V to continue to be a mainstay of HIV treatment long into the future, and our investigational capsid inhibitor, lenacapavir, could be a best-in-class, long-acting option for both treatment and prevention. Lenacapavir is highly potent, and importantly, its flexible dosing profile gives us the potential to develop multiple long-acting treatments and prevention. In 2021, we expect a number of important milestones in the areas I've just mentioned. Merdad will provide more detail on the regulatory milestone.

We expect big targeted and continued to be a mainstay of HIV treatment long into the future.

And our investigational capsid inhibitor and a cap of year could be a best in class long acting option for both treatment and prevention.

<unk> is a highly potent and importantly, its flexible dosing profile. It gives us the potential to develop multiple long acting treatment and prevention options.

In 2021, we expect a number of important milestones in the areas I've just mentioned.

<unk> will provide more detail on the regulatory milestones and I will highlight a few for now within the broader context of what you can expect from us.

Daniel O'Day: And I will highlight a few for now within the broader context of what you can expect from us, starting with our leadership in antivirals. We will, of course, be focused on the continued growth of BicTarvi and maintaining its leadership as the number one prescribed treatment for HIV in major markets. We plan to file an NDA in the U.S. for lenacapivir in a heavily treatment-experienced population. This should be in the second half

Starting with our leadership and anti Virals.

We will of course be focused on the continued growth of big Tarbey and maintaining its leadership as the number one prescribed treatment for HIV and major markets.

We plan to file an NDA and the U S for Atlantic cap of year, and they're heavily treatment experienced population.

There should be and the second half of the year.

Daniel O'Day: We will also continue to explore the right options for combination. In viral hepatitis, we look forward to expanding our business in HBV and HDV by growing sales of Venliti in the U.S. and Asia and, pending completion of the MIR acquisition, the anticipated filing of a BLA in the second half of. For Vic Glory, we look to realize the full potential of the therapy as the pandemic evolves. As you know, we are studying new formulations and routes of administration for Viclory as a treatment for COVID-19.

We will also continue to explore the right options for combinations.

And viral hepatitis, we look forward to expanding our business and HBV and H D V by growing sales have been liddy and the U S and Asia and pending completion of the mere acquisition and the anticipated filing of a BLA and the second half of the year.

For the Glory, we look to realize the full potential of the therapy as the pandemic evolves.

As you know we are studying new formulations and routes of administration perfect Glory as a treatment for COVID-19.

With the strong anti Virals business as our foundation, we are looking forward to the continued expansion of oncology as a new pillar of growth.

Daniel O'Day: With the strong antivirals business as our foundation, we are looking forward to the continued expansion of oncology as a new pillar of growth. Tridelby, which will have its first full year on the market following approval, will be a significant contributor to our growth this year. We expect to hear about conversion from accelerated to full approval in the coming weeks based on the FDA review of the assent data. At the same time, we'll be pursuing the many pipeline opportunities for Tridel. It is currently being studied in 10 different tumor types.

<unk>, which will have its first full year on the market following approval will be a significant contributor to our growth this year.

We expect to hear about.

Conversion from accelerated to full approval in the coming weeks based on the FDA review of the ascent data.

At the same time, we will be pursuing the many pipeline opportunities for <unk>.

It is currently being studied and 10 different tumor types, we expect to hear from the FDA on accelerated approval for <unk> and.

Daniel O'Day: We expect to hear from the FDA on accelerated approval for TRODELV in metastatic urothelial cancer in the first half of the year. And we're also anticipating a readout of the Phase 3 Tropics 2 study in hormone receptor positive HER2 negative breast cancer in the second... Data from the Phase 3 Zuma 7 study is expected in the first half of the year for Yaskarta's potential expansion into second-line D And we should see Phase 1b data from Agrolimab in MDS in the second half of the year, with the possibility of a regulatory submission based on these results. In addition, we'll assess opt-in opportunities throughout the year as data becomes available and continue to advance our internal program.

In metastatic <unk> cancer, and the first half of the year.

And we're also anticipating a readout of the phase III tropics, <unk> study and hormone receptor positive her two negative breast cancer and the second half.

Data from the Phase III Zuma seven study is expected in the first half of the year for <unk> potential expansion into second line D. L. B C L.

And we should see phase <unk> data from our goal of Mab and Mds and the second half of the year with the possibility of a regulatory submission based on these results.

In addition.

And we will assess often opportunities throughout the year as data becomes available and continued to advance our internal programs.

I wanted to add that we are focused on prioritizing in order to deliver on these opportunities. We now have a portfolio that allows us to be much more selective in terms of what we take forward.

Daniel O'Day: I want to add that we are focused on prioritizing in order to deliver on these opportunities. We now have a portfolio that allows us to be much more selective in terms of what we take forward. This means being very disciplined about investing where there is the highest potential value.

This means being very disciplined about investing where there is highest potential value.

Daniel O'Day: You've seen some of that with our decisions around Phil Godnib and our investment in Trodel. Just briefly, on the enterprise level, I. We will continue to expand our talent base and deepen our expertise outside antivirals as we did in 2020. We will also maintain our strong focus on inclusion and diversity. As part of this, we are strengthening our efforts to promote racial equity.

You've seen some of that with our decisions around fugard nib and our investment in Philadelphia.

Just briefly on the enterprise level activities, we will continue to expand our talent base and deepen our expertise outside anti virals as we did in 2020.

We will also maintain our strong focus on inclusion and diversity.

As part of this we are strengthening our efforts to promote racial equity.

Daniel O'Day: Today we announce that Gilead has become a founding member of a coalition called 110. This is a group of U.S. companies that are committed to hiring and promoting 1 million black Americans into family-sustaining jobs over the next 10 years. In addition, we will continue to advance our ESG program and targets in line with our strategy. We will update you on our progress in these areas each quarter. There's a lot of important work ahead of us in 2021, and we're very much looking forward to turning our opportunities into tangible progress that will benefit patients, communities, and our shareholders. With that, I'll now pass the call to Dan. Thank you, Dan, and good afternoon, everyone.

Today, we announced the Gilead has become a founding member of a coalition called 110 and.

This is a group of U S companies that is committed to hiring and promoting 1 million Black Americans into family sustaining jobs over the next 10 years.

In addition, we will continue to advance our ESG program and targets in line with our strategy.

We will update you on our progress in these areas each quarter.

There's a lot of important work ahead of us from 2021, and we're very much looking forward to turning our opportunities and to tangible progress that will benefit patients communities and our shareholders.

With that I'll now pass over the call to Andy.

Thank you Dan and good afternoon, everyone.

Andrew D. Dickinson: Our performance was strong for the fourth quarter and full year 2020, a clear reflection of the solid underlying fundamentals of our business and the increased demand we saw for Veclurie amid the COVID-19 pandemic. You will find our detailed Q4 and full year 2020 results in the press release and materials we have posted on our website. Today, I will review our Q4 and full year 2020 performance and provide our guidance for 2021.

And our performance was strong for the fourth quarter and full year 2020, a clear reflection of the solid underlying fundamentals of our business and the increased demand we saw for victory amid the COVID-19 pandemic.

You will find our detailed Q4 and full year 2020 results and the press release and materials, we have posted on our website.

Today, I will review, our Q4 and full year 2020 performance and.

And provide our guidance for 2021.

Andrew D. Dickinson: Turning now to the financial highlights. Total revenues for the fourth quarter of 2020 were $7.4 billion, with non-GAAP diluted earnings per share of $2.19. This compares to total revenue of $5.9 billion with non-GAAP diluted earnings per share of $1.10 for the same period last year. Non-GAAP diluted earnings per share for the quarter increased 99% year-over-year primarily due to higher product sales, improved gross margin driven by a prior year inventory charge, and a lower tax rate.

Turning now to the financial highlights.

Total revenues for the fourth quarter 2020 were $7 4 billion with non-GAAP diluted earnings per share of $2 19.

This compares to total revenue of $5 9 billion with non-GAAP diluted earnings per share of $1.10 for the same period last year.

Non-GAAP diluted earnings per share for the quarter increased 99% year over year, primarily due to higher product sales improved gross margin driven by a prior year inventory charge and a lower tax rate.

Andrew D. Dickinson: This was partially offset by increased R&D and SG&A investments, including a $190 million charge recorded in the fourth quarter of 2020 related to amending our agreement with Galapagos. Product sales for the fourth quarter and full year were $7.3 billion and $24.4 billion, up 26% and 10%, respectively, compared to the same periods last year, as the most recent COVID-19 surge drove uptake of Vic Lurie. Subsequently, this increase was partially offset by the loss of exclusivity of Atripla and Truvada in the U.S. in October.

This was partially offset by increased R&D, and SG&A investments, including $190 million charge recorded in the fourth quarter of 2020 related to amending our agreement with Galapagos.

Product sales for the fourth quarter and full year were $7 3 billion and $24 4 billion up 26% and 10% respectively compared to the same periods last year as the most recent COVID-19 surge drove uptake and Vic Larry.

Sequentially. This increase was partially offset by the loss of exclusivity of a AAA and truvada in the U S. In October.

Victory contributed $1 9 billion and $2 8 billion and sales for the fourth quarter and full year 2020, largely driven by increased utilization and COVID-19, hospitalizations and the U S.

Andrew D. Dickinson: Vecluri contributed $1.9 billion and $2.8 billion in sales for the fourth quarter and full year of 2020, largely driven by increased utilization and COVID-19 hospitalizations in the U.S. For the full year, excluding VECLURI, product sales were down 3% due to the recent losses of exclusivity for Atripla, Truvada, Latteris, and Renexa in the US, as well as the impact of the COVID Despite the impact of the pandemic and the LOEs relating to Atripoline Trivada in the U.S., HIV revenue grew 3% year-over-year, driven by BicTarvi and Dyscovi. For Q4, product sales, excluding Vecluri, decreased 4% sequentially, primarily due to the Atripla and Truvada LOEs.

For the full year, excluding <unk> product sales were down 3% due to the recent losses of exclusivity for a triple and Truvada, let Harris and <unk> and the U S as well as the impact of the COVID-19 pandemic on our HIV and HCV franchises.

Despite the impacts of the pandemic and the eloise relating to a triple and Truvada and the U S. HIV revenue grew 3% year over year, driven by <unk> and <unk>.

For Q4 product sales, excluding <unk> decreased 4% sequentially, primarily due to the a triple net and Truvada LOE.

Cell therapy revenues were up 34% for the fourth quarter and 33% for the year, primarily due to the continued uptake of <unk> card and Europe and the U S launch of <unk> in July.

Andrew D. Dickinson: Cell therapy revenues were up 34% for the fourth quarter and 33% for the year, primarily due to the continued uptake of Yescarta in Europe and the U.S. launch of Ticardus in July. Now, turning to expenses. Non-GAAP cost of goods sold was $918 million for the fourth quarter and $3.3 billion for the year, down 35% and 8%, respectively, compared to the same periods last year. 2020 cost of goods sold was lower primarily because of a $500 million inventory write-down charge in Q4 of 2019. Excluding this, non-GAAP product margins remain relatively flat year over year.

Now turning to expenses.

Non-GAAP cost of goods sold was $918 million for the fourth quarter and $3 $3 billion for the year down, 35% and 8% respectively compared to the same periods last year.

2020 cost of goods sold was lower primarily because of a $500 million inventory write down charge in Q4 of 2019.

Excluding this non-GAAP product margins remained relatively flat year over year.

Non-GAAP R&D expense for the quarter was $1 5 billion up 31% sequentially and up 37% year over year, primarily driven by the $190 million charge associated with the Galapagos Amendment that I mentioned earlier, and approximately $70 million and milestones paid to pioneer as well as pipeline <unk>.

Andrew D. Dickinson: Non-GAAP R&D expense for the quarter was $1.5 billion, up 31% sequentially and up 37% year-over-year, primarily driven by the $190 million charge associated with the Galapagos Amendment that I mentioned earlier, and approximately $70 million in milestones paid to Pioneer, as well as pipeline investments in Tredelvi and McGrola Maps. For the full year, non-GAAP R&D expense was up 20% year-over We have also increased our investment in oncology programs, including Tredelvi and McRoll-Mapp.

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For the full year non-GAAP R&D expense was up 20% year over year, primarily due to our significant investment in <unk>.

We also increased our investment and oncology programs, including <unk> and Mcgraw and map.

Andrew D. Dickinson: These increases in investment were partially offset by lower clinical expenses from the completion of certain inflammation programs and postponement of certain clinical trials due to the pandemic. Non-GAAP SG&A expense for the quarter was $1.5 billion, up 37% sequentially, and up 25% year-over-year.

These increases and investment were partially offset by lower clinical expenses from the completion of certain inflammation programs and postponement of certain clinical trials due to the pandemic.

Non-GAAP SG&A expense for the quarter was $1 5 billion up 37% sequentially and up 25% year over year.

Andrew D. Dickinson: The increase in the quarter was driven by the timing of marketing expenses related to Biktarvy, along with Vecluri and Tredelvi commercialization efforts, and higher spend on corporate grants to support philanthropic organizations. We allocated significant additional funds to non-profit grantees in Q4 to support racial equity and social justice efforts, help our non-profit grantees weather the pandemic, and provide for our signature-giving For the full year, non-GAAP SG&A expense increased 10% as a result of higher costs associated with the commercialization efforts for EvacLurie, our continued expansion in China, increased corporate grants, remdesivir donations, and a $97 million charge related to a previously disclosed legal settlement.

The increase in the quarter was driven by the timing of marketing expenses related to big Tarbey, along with victory and for Dolby commercialization efforts and higher spend on corporate brands to support philanthropic organizations.

And we allocated significant additional funds to nonprofit green teas, and Q4 to support ratio equity and social Justice efforts.

Our nonprofit grantees, whether the pandemic and provide for our signature giving programs, including compass Radian and help connect.

For the full year non-GAAP SG&A expense increased 10% as a result of higher costs associated with the commercialization efforts Rebecca Clary. Our continued expansion in China increased corporate grants rem density or donations and a $97 million charge related to a previously disclosed legal settlement.

Turning to our balance sheet during the quarter, we generated $1 $9 billion of cash flow from operations.

Andrew D. Dickinson: Turning to our balance sheet, during the quarter, we generated $1.9 billion of cash flow from operations, paid $858 million in dividends, and drew down a $1 billion term loan in connection with the closing of our $21 billion acquisition of Immunomedic. For the year, we returned approximately 67% of free cash flow to our shareholders, consisting of $3.4 billion in dividends and $1.6 billion in share repurchases. We also repaid $1 billion of debt on January 1st of this year.

$858 million and dividends and drew down a $1 billion term loan in connection with the closing of our $21 billion acquisition of Immunomedics for.

For the year, we returned approximately 67% of free cash flow to our shareholders, consisting of $3 4 billion and dividends and $1 $6 billion and share repurchases. We also repaid $1 billion of debt on January one of this year.

Andrew D. Dickinson: Turning to our guidance for 2021. Our 2021 non-GAAP financial guidance is summarized on slides 18 and 19 in the earnings presentation available on our website. As always, our guidance is based on our current expectations for our business in 2021, and results may vary depending upon, among other things, the impacts of the COVID-19 pandemic, which remain unpredictable. In addition, while our guidance reflects the impact of recent corporate development transactions and our planned acquisition of MIR, as well as funding for ordinary course partnering activities in 2021, our guidance does not factor in the possibility of any extraordinary business development costs or acquisitions With that background, we expect that product sales excluding Veclurie in 2021 will be in the range of $21.7 billion to $22.1 billion.

Turning to our guidance for 2021.

Our 2021 non-GAAP financial guidance is summarized on slides 18, and 19 and the earnings presentation available on our website.

As always our guidance is based on our current expectations for our business in 2021 and results may vary depending upon among other things the impacts of the COVID-19, pandemic, which remain unpredictable and.

In addition, while our guidance reflects the impact of recent corporate development transactions and our planned acquisition of mirror as well as funding for ordinary course, partnering activities and 2021, our guidance does not factor and the possibility of any extraordinary business development cost or the or acquisitions or significant opt ins that we may complete over.

And the course of the coming year.

With that background, we expect net product sales, excluding VAT glory for 2021 will be and the range of $21 7 billion to $22 1 billion.

Andrew D. Dickinson: Due to the uncertainty related to the pandemic, we expect Vecluri revenue to be in the range of $2 to $3 billion U.S. dollars, which results in a total product sales range of $23.7 billion to $25.1 billion. As we've discussed over the past quarters, Vecluri in many ways acts as a hedge against the potential impacts of a continued COVID-19 pandemic. This guidance reflects anticipated revenue growth of approximately 9-10%, excluding LOEs and VEC-Lurie, driven by growth from Biktarvy, Tridelvy, Vemlity, and our Cell Therapy franchise.

Due to the uncertainty related to the pandemic, we expect that glory revenue to be and the range of $2 billion to $3 billion, which results in total product sales range of $23 $7 billion to $25 1 billion.

And as we've discussed over the past quarters like Lori and many ways acts as a hedge against the potential impacts of a continued COVID-19 pandemic.

This guidance reflects anticipated revenue growth of approximately 9% to 10%, excluding <unk> and <unk> driven by growth from victory <unk> them Liddy and ourselves therapy franchise.

Andrew D. Dickinson: And while there remains uncertainty with the pandemic, we are making certain assumptions regarding the recovery and underlying market dynamics starting in the second quarter of 2021, while COVID-19 vaccinations accelerate. Any delay in the vaccine rollouts or any significant reacceleration of the global pandemic could once again adversely impact our business. As a reminder, looking ahead to Q1, we anticipate total product sales excluding Vecluri will decline by a low single-digit percentage, similar to what we've seen over the past three years. This is expected to be driven by customary U.S. seasonal inventory patterns and buying patterns of public payers that negatively affect our payer mix in the first quarter.

And while there remains uncertainty with the pandemic, we are making certain assumptions regarding the recovery and underlying market dynamics, starting in the second quarter of 2021, and as COVID-19 vaccinations accelerating.

Any delay with the vaccine rollouts or any significant reacceleration of the global pandemic could once again adversely impact our business.

As a reminder, looking ahead to Q1, we anticipate total product sales, excluding Blackberry will decline by a low single digit percentage similar to what we've seen over the past three years.

This is expected to be driven by customary U S seasonal inventory patterns and buying patterns of public payers that negatively affect our payer mix in the first quarter.

In addition, unlike prior years Q1 of 2021 will also be impacted by the recent loss of exclusivity of a triplet and truvada and the United States.

Andrew D. Dickinson: In addition, unlike prior years, Q1 of 2021 will also be impacted by the recent loss of exclusivity for ATRIPLA and TRUVADA in the United States. However, despite this anticipated sequential decline in Q1 total product sales, we remain very confident in the health of our business, as reflected in our guidance for the coming year. Turning to our expectations for our product gross margins in 2021, our non-GAAP product gross margins are expected to be in the range of 87 to 88% in 2021, consistent with our historic range.

Despite this anticipated sequential decline in Q1 total product sales, we remain very confident and the health of our business as reflected in our guidance for the coming year.

Turning to our expectations for our product gross margins in 2021.

Our non-GAAP product gross margins are expected to be and the range of 87% and 88% and 2021 consistent with our historic range.

Andrew D. Dickinson: With respect to our operating expenses in 2021, we expect that both non-GAAP R&D and non-GAAP SG&A expenses will see a flat to low single-digit percentage decline through disciplined expense management, with flexibility to continue investing in our R&D pipeline and other strategic opportunities going forward. This guidance includes the impact of our planned acquisition of Mirror, as well as our allocation of approximately $350 million for future investments and ordinary course R&D collaborations In addition, our SG&A guidance reflects the expected impact in 2021 of our oncology buildout and funding for a number of time-limited corporate initiatives related to information technology and data analytics.

With respect to our operating expenses and 2021, we expect that both non-GAAP R&D and non-GAAP SG&A expenses, we will see a flat to low single digit percentage decline through disciplined expense management with flexibility to continue investing and our R&D pipeline and other strategic opportunities going forward.

This guidance includes the impact of our planned acquisition of mirror as well as our allocation of approximately $350 million for future investments and ordinary course, R&D collaborations and.

In addition, our SG&A guidance reflects the expected impact in 2021 of our oncology Buildout and funding for a number of time limited corporate initiatives related to information technology and data analytics.

Our non-GAAP operating income is expected to be and the range of $11 5 billion to $12 9 billion in 2021, and our non-GAAP effective tax rate for the year is expected to be approximately 21%, which is higher than 2020, primarily due to a decrease and tax credits and settlements with tax authorities that.

Andrew D. Dickinson: Our non-GAAP operating income is expected to be in the range of $11.5 billion to $12.9 billion in 2021, and our non-GAAP effective tax rate for the year is expected to be approximately 21%, which is higher than in 2020, primarily due to a decrease in tax credits and settlements with tax authorities that reduced our 2020 tax rate. Non-GAAP diluted EPS is expected to be in the range of $6.75 per share to $7.45 per share, driven by increased operational efficiencies as compared to 2020 and partially offset by the higher non-GAAP effective tax rate, along with greater projected interest expense and lower projected interest income as compared to 2020.

Reduced our 2020 tax rate.

Non-GAAP diluted EPS is expected to be and the range of $6 75 per share to $7 45 per share driven by increased operational efficiencies as compared to 2020, and partially offset by the higher non-GAAP effective tax rate along with greater projected interest expense and lower project.

Net interest income as compared to 2020.

Our balance sheet remains robust and our capital allocation priorities are unchanged, we remain focused on continuing to prioritize investment and our business and R&D pipeline and maintaining a rigorous focus on disciplined expense management.

Andrew D. Dickinson: Our balance sheet remains robust, and our capital allocation priorities are unchanged. We remain focused on continuing to prioritize investment in our business and R&D pipeline and maintaining a rigorous focus on disciplined expense management. Finally, we continue to be committed to growing our dividend over time, and we were pleased to announce earlier today that we have increased our dividend by 4.4% for 2021. Additionally, as we disclosed a few weeks ago, we plan to repay at least $4 billion of debt this year, including the $1 billion of debt we repaid at the beginning of this year. We also expect to repurchase shares to offset dilution from equity compensation plans.

And finally, we continue to be committed to growing our dividend over time, and we were pleased to announce earlier today that we have increased our dividend by four 4% for 2021 <unk>.

Additionally, as we disclosed a few weeks ago, we plan to repay at least $4 billion of debt this year, including the $1 billion of debt, we repaid at the beginning of this year.

We also expect to repurchase shares to offset dilution from equity compensation plans.

Johanna Mercier: I'll now turn the call over to Johanna, and good afternoon everyone. I'll begin by taking you through some of the market dynamics we saw in the fourth quarter as we continue to navigate the COVID-19 pandemic and the impact that it's had on our business. As we entered the quarter in the U.S. and around the world, the number of COVID-19 cases surged, and this had two significant effects on our business.

I'll now turn the call over to Joanna.

Thanks, Andy and good afternoon, everyone.

I'll begin by taking you through some of the market dynamics, Nissan and the fourth quarter and we continue to navigate the COVID-19 pandemic and the <unk>.

Capex pattern that Daniel.

And we entered the quarter and you asked and around the world and number of COVID-19 cases terex.

And this had two significant effects on our business.

Johanna Mercier: Recovery was dampened by our hep C and HIV medications as people delayed visits to their health care providers, and the number of hospitalizations of patients with COVID-19 dramatically increased, leading to significant uptakes of their clearance. Driven by Vic Lurie, we had robust growth in Q4, with a 13% increase in total product sales compared to the prior quarter. However, excluding Vicklery revenues, our business declined 4% amid the pandemic and loss of exclusivity for Chippewa and Chewbacca in the U.S.

He was dampened by our Hep C and HIV medications and people who have a visit to their health care provider.

And and the number of hospitalizations and patients with COVID-19 dramatically increase leading to significant uptake of victory.

Driven by victory, we had robust growth in Q4, and a 13% increase and total product sales compared to the prior quarter.

Excluding that clarity revenue I didn't have.

<unk> declined 4% and need the pandemic and loss of exclusivity hardship and Savannah.

Overall, while we expect the pandemic to continue to cause near term uncertainty, we're confident and the strong underlying trend, which I'll highlight for you. This afternoon.

Johanna Mercier: Overall, while we expect the pandemic to continue to cause near-term uncertainty, we're confident in the strong underlying trends, which I'll highlight for you this afternoon, starting with HIV. We saw 3% growth in sales across our HIV franchise in 2020 compared with the prior year, despite the Etrepla and Truvada LOU. VicTarvi continues to stand out in the HIV treatment market, growing 10% sequentially and 53% year over year. It remains the number one prescribed regimen across key global markets and in the U.S., where one in two new patients start on it. In preparation, we ended the year with a 46% U.S. market share for Discovi, exceeding our goal of 40 to 45%.

Starting with HIV.

And you've got 3% growth and sales across our HIV franchise in 2020 compared with the prior year. Despite the challenge of allergies.

It's Harvey continues to stand out and the HIV treatment market growing 10% sequentially and 53% year over year.

<unk> remains the number one prescribed branded regimen across key global markets and <unk>.

And we're wanting to new patient starts Monday tabby.

And Pat we ended the year with a 46% U S market share forgets Kobe exceeding our goal at 40% to 45%.

Johanna Mercier: As expected, we saw a generic competitor enter the marketing Q4, impacting Trivada revenues as we work to maintain strong commercial access for disabled patients. Going forward, we expect demand for PrEP to recover as the pandemic subsides, and we will stay competitive growing the business with the market. This generic competition and the surge in the pandemic led to a decline in Q4 HIV revenues of 6% sequentially and 7% year-over-year.

As expected we saw generic competitor enter the market and Q4 impacting ciabatta revenue as we work to maintain strong commercial assets for the Kennedy.

Going forward, we expect demand for Pratt COVID-19 cover at the pandemic subsides, and we will stay competitive growing the business with the market.

It's generic competition and the surge and the pandemic led to a decline in Q4, HIV revenue of 6% sequentially and 7% year over year and.

Johanna Mercier: In addition, in line with historical trends, we saw seasonal inventory build in Q4, which we expect to bleed out into Q1 of this year. We're well positioned and confident in our leadership in HIV today and in the future. Harvey will continue to be a key growth driver as the go-to single-tablet regimen for HIV treatment with patent protection extending to 2033 in the U.S. as well as the European Union. We remain enthusiastic about the prospect of growing our leadership as we advance our long-acting antiviral lineages.

In addition in line with historical trends, we saw seasonal inventory build in Q4, which we expect to bleed out into Q1 and this year.

We're well positioned and confident and our leadership and HIV today and in the future.

Charlie will continue to be a key growth driver as the go to single tablet regimen for HIV treatment.

Patent protection and extending to 2033 and the U S as wireless and European Union.

We remain enthusiastic about the prospects of growing our leadership as we advance our long acting antivirals and many carpathia.

Johanna Mercier: Success in the long-acting market will depend on having a product candidate with the right profile for patients. We believe Lena Cavier has the potential to be that, and Merdad will share more detail about its profile in his. Turning to fidelity, as Dan mentioned, we completed our acquisition of Immunomatics. During the quarter, Tredelby recorded $64 million in sales, with $49 million of that revenue recognized by Gilead following the close of the acquisition, for a full year total of $137 million in revenue.

Success, and the long acting Mark it will depend on having a product candidate with the right profile for patients.

We believe Atlantic heavier has the potential to be that product and merit and we'll share more detail about it profile and his remarks.

Turning to hit all day.

John mentioned, we completed our acquisition of Immunomedics and October during the quarter. So GAAP.

The accordion, and 64 million and sales with $49 million of that revenue back to nice like Gilead. Following the close of the acquisition, where full year totaling $137 million and revenue.

I'm impressed with the topic that teams have made launching and medication and need the pandemic.

Johanna Mercier: I'm impressed with the progress the teams have made launching the medication amid the pandemic. In its first eight months, Trigelby has become the clear number one therapy in third-line metastatic triple negative breast cancer. The breadth of Trudelvy adoption and recognition of the product continues to grow, and we're now seeing unaided Trudelvy awareness of above 90% among physicians in academic institutions. Our ambition is to achieve similar awareness numbers with community providers, which will be driven by the anticipated full FDA approval of Tredelvi for metastatic tibial negative breast cancer and publication of the previously presented assent data in the first half of 2021. We're also on track to complete the European filing in the first quarter of this year. Pacifica Habitatus, The COVID-19 surge impacted the recovery we saw in Q3 across our HCD franchise.

And its first eight months.

And we have become the clear number one therapy and third line metastatic triple negative breast cancer.

Aggressive to get the adoption and recognition of the product continues to grow and we're now seeing unaided awareness of about 90% amongst physicians and academic institutions.

Our ambition is to keep similar awareness numbers with community providers, which will be driven by the anticipated FDA approvals and <unk> for metastatic triple negative breast cancer and publication of the previously presented.

In the first half of 2021.

We're also on track to complete and European filing in the first quarter of this year.

Specific to hepatitis.

The COVID-19 surge impacted and recovery, we saw in Q3 across our HCV franchise.

Johanna Mercier: Our HCD business showed a 9% sequential decline impacted by the pandemic and timing of purchases and markets outside. We continue to maintain anywhere between 50 and 60% market share across our core markets, which we believe sets us well for. In HBV, we expect to continue to grow our business and anticipate sales exceeding $1 billion by 2022, driven by the U.S. and Asia. We're looking forward to closing the mirror acquisition, which will bring Hapkudex to Gilead.

Our HDD business and 9% sequential decline impacted by the pandemic and.

Timing of fixtures and market outside of the U S.

We continue to maintain anywhere between 50, and 60% market share across our core market, which we believe well per recovery.

And HBV and we expect to continue to grow our business, Inc and.

And just keep sales exceeding 1 billion by 'twenty and 'twenty Q driven by the U S and Asia market.

And we're looking forward to closing the mere acquisition, which will bring you have crude ex to gilead and <unk>.

Johanna Mercier: Medicine is a first-in-class and potentially best-in-class treatment for hepatitis D or HDD, an orphan disease that has been historically underdiagnosed and for which there were no approved treatment options prior to. HPV is the most severe form of viral hepatitis and is associated with poor long-term survival.

Madison is a first in class and potentially best in class treatment for hepatitis D. R. H D D.

And I seem to be that has been historically underdiagnosed and for which there were no approved treatment options.

<unk> is the most severe form of viral hepatitis and is associated with poor long term survival rate, we believe our experience and hepatitis and the operational synergies with respect to Gilead existing field force and HDD will allow us to reach patients with H D D.

Johanna Mercier: We believe our experience in hepatitis and the operational synergies with respect to Gilead's existing field force in HBV will allow us to reach patients with HBV, had Cludex already had conditional approval in Europe and remains an investigational agent in the U.S. Following the close of the deal, we anticipate filing for U.S. approval in the second half of this year. In closing, I just want to share a few As Dan noted, sticklery remains an important treatment option for hospitalized patients with COVID-19.

<unk> already has conditional approval in Europe, and remains an investigational agent and as well pending.

Pending the close of the deal we anticipate filing for U S approval and the second half and thank you.

In closing I, just wanted to share a few remarks about back Larry.

Dan noted and clearly remains an important treatment option for hospitalized patients with COVID-19.

Johanna Mercier: We're seeing utilization rates of 50 to 60% among eligible patients in the U.S. and are very proud of the role we have played in helping patients during this challenging time. As we've seen over the past year, predicting the trajectory of the pandemic has proven difficult, to say the least. We anticipate demand will continue to fluctuate as COVID-19 cases rise and fall. While we're encouraged by the progress our industry has made with the introduction of vaccines, we expect Clery to remain a critical tool for patients and physicians well into the future. And now, I'd like to turn the call over to you.

We're seeing utilization rates of 50%, 60% among eligible patients who need that.

Proud and thankful, we played in helping patients during this challenging time.

And we've seen over the past year predicting the trajectory and the pandemic has proven difficult to say to Lee we anticipate demand will continue to fluctuate and COVID-19 cases, right and Paul.

We are encouraged by the progress of our industry has made with the introduction and vaccine, we expect to clear and Google made a critical tool per patient and position well into the future.

And now I'd like to turn the call over to Matt.

Merdad V. Parsey: Thanks, Johanna, and good afternoon, everyone. I'm pleased to share with you some updates on our pipeline as we made tremendous progress in 2020, expanding and diversifying our portfolio across our therapeutic areas. We enter 2021 with a larger, more balanced clinical pipeline that gives us the opportunity to advance important new therapies aimed at addressing significant unmet medical needs now and in the future. Through acquisitions, partnerships, and by advancing internal candidates, we grew our portfolio of projects by 50% last year, and I look forward to sharing more about that with you today. I'll start with oncology.

Thanks, Shannon and good afternoon, everyone.

I am pleased share with you some updates on our pipeline as we made tremendous progress in 2020, expanding and diversifying our portfolio across our therapeutic areas.

We entered 2021 with a larger more balanced clinical pipeline that gives us the opportunity to advance important new therapies aimed at addressing significant unmet medical needs now and in the future.

Through acquisitions partnerships and by advancing internal candidates, we grew our portfolio of projects by 50% last year and I look forward to sharing more about that with you today.

I'll start with oncology and.

Merdad V. Parsey: In 2020, we significantly enhanced our oncology portfolio, which now has 27 internal clinical stage oncology programs aimed at patients with the greatest unmet medical need. At the center of our oncology portfolio is, of course, Tredelphi. As Dan and Johanna mentioned, we anticipate several key clinical milestones this year that will help us broaden Tridelby's use and understand which patients are most likely to benefit, with the accelerated approval for third-line metastatic triple negative breast cancer in hand.

In 2020, we significantly enhanced our oncology portfolio and now has 27 internal clinical stage oncology programs aimed at patients with the greatest unmet medical needs.

At the center of our oncology portfolio is of course <unk> and.

As Dan and Joanna mentioned, we anticipate several key clinical milestones. This year that will help us broaden to adobe's use and understand which patients are most likely to benefit.

With the accelerated approval for third line metastatic triple negative breast cancer and hand, we look forward to the anticipated full approval of <unk> for patients with metastatic third line triple negative breast cancer supported by the confirmatory phase III ascent study.

Merdad V. Parsey: We look forward to the anticipated full approval of TRDEL-V for patients with metastatic third-line triple negative breast cancer, supported by the confirmatory phase three assent study. You'll recall that these are really strong data. Despite having received a median of four prior anti-cancer regimens, patients treated with Tredelvi showed a statistically significant and clinically meaningful improvement in overall survival, with a median survival of 12.1 months compared with 6.7 months for chemotherapy, and a hazard ratio of 0.48.

You'll recall that these are really strong data. Despite having received a median of four prior inc. Anti cancer regimens.

And is treated with <unk> showed a statistically significant and clinically meaningful improvement and overall survival with a median survival of 12, one months compared with $6 seven months for chemotherapy and hazard ratio of 0.48.

These data have been accepted for publication and we anticipate publication and these results and a peer reviewed journal early this year.

These data had said had set for adobe on the path to becoming the new standard of care for patients with third line metastatic triple negative breast cancer.

Merdad V. Parsey: These data have been accepted for publication, and we anticipate publication of these results in a peer-reviewed journal early this year. These data have set Tredelphi on the path to becoming the new standard of care for patients with third-line metastatic triple negative breast cancer. Additional data have demonstrated that TRODELV has the potential to transform care for people with metastatic urothelial carcinoma, the most common form of bladder cancer. We've submitted an application for accelerated approval to the FDA, and we anticipate a decision in the first half of this year.

Additional data have demonstrated that <unk> has the potential to transform care for people with metastatic urothelium carcinoma. The most common form of bladder cancer.

We have submitted an application for accelerated approval to the FDA and anticipated decision and the first half of this year.

Next we're looking to further expand to adobe for patients with hormone.

Receptor positive her two negative breast cancer, which accounts for approximately 70% to 75% of all forms of breast cancer and those study results are expected in the second half of the year.

Merdad V. Parsey: Next, we're looking to further expand tridelby for patients with hormone receptor-positive HER2-negative breast cancer, which accounts for approximately 70 to 75 percent of all forms of breast cancer. And those study results are expected in the second half of the year. Beyond breast and bladder cancers, we're working quickly to explore other tumors with the goal of establishing the breadth of Tordalby's activity.

Beyond breast and bladder cancers, we're working quickly to explore other tumors with the goal of establishing the breath of <unk> activity will continue.

And to evaluate the role of trop two expression in tumors along the way.

One of the trials, we're leveraging is the Trump ex three basket study, where we continue to enroll patients we plan to provide and update on this study, particularly non small cell lung cancer and the second half of this year.

Merdad V. Parsey: We'll continue to evaluate the role of Trope 2 expression in tumors along the way. One of the trials we're leveraging is a TROPICS-3 basket study where we continue to enroll patients. We plan to provide an update on this study, particularly in non-small cell lung cancer, in the second half of this year. We are proceeding at risk with plans to start a randomized study in lung cancer in the second half of this year as well, pending Proctotics 3 data.

We are proceeding at risk with plans to start a randomized study in lung cancer and the second half of the year as well and pending per tropics III data.

We expect to begin and a substantial number of new studies with <unk>. This year, adding to the four internal and 13 ongoing investigator sponsored studies.

Now moving on to the Gorilla math, we're rapidly advancing this program.

The goal of helping patients with hematologic malignancies, and exploring the role of exceeded 47 inhibition and the treatment of solid tumors.

Merdad V. Parsey: We expect to begin a substantial number of new studies with Tridelvy this year, adding to the four internal and 13 ongoing investigator-sponsored studies. Now moving on to Megrolimab, we're rapidly advancing this program with the goal of helping patients with hematologic malignancies and exploring the role of CD47 inhibition in the treatment of solid tumors. The first solid tumor studies are set to begin as early as this year.

The first solid tumor studies are set to begin as early as this year.

We expect results from the Phase <unk> study and Mds later, this year, which will inform our ongoing ongoing discussions with the FDA pending these data we could potentially file for accelerated approval and.

In addition, we've begun enrolling patients and the phase III enhance study intended to support full approval and to confirm the phase <unk> data.

Moving to Kate we're very pleased with the process and progress of our colleagues at kite.

Merdad V. Parsey: We expect results from the Phase 1b study and MDS later this year, which will inform our ongoing discussions with the FDA. Pending these data, we could potentially file for accelerated approval. In addition, we've begun enrolling patients in the Phase 3 Enhanced Study intended to support full approval and to confirm the Phase 1b data. Moving to KITE, we're very pleased with the process and progress of our colleagues at KITE that is being made with the company's cell therapy medicines, bringing Ascarta and Ticardis to new diseases and to patients earlier in their treatment.

That is being made with the companys cell therapy medicines, bringing scarlet and <unk> as to new diseases and to patients earlier in their treatment.

In addition to the second line <unk> data that Dan mentioned.

And were expected that are expected and the first half of this year, we filed for approval to expand the use of yes Carter to patients with indolent NHL.

If approved this would be the first car T therapy for patients with this form of lymphoma.

We're also excited about the emerging data from our partnerships, including <unk> anti <unk> and CD 73 inhibitor programs as well as our collaborations with pioneer and to Zona to name a few.

Merdad V. Parsey: In addition to the second-line DLBCL data that Dan mentioned that are expected in the first half of this year, we filed for approval to expand the use of YesGuarda to patients with indolent NHL. If approved, this would be the first CAR T therapy for patients with this form of lymphoma.

Taken in total these agreements and both oncology and other therapeutic areas allows us to expand the breadth of our portfolio with access to cutting edge research programs and a way that manages the risk of our internal portfolio.

We've intentionally constructed a pipeline with a large number of programs and phase one and fewer.

Merdad V. Parsey: We're also excited about the emerging data from our partnerships, including ARCIS's anti-TIGIT and CD73 inhibitor programs, as well as our collaborations with Pioneer and Tizona, to name a few. Taken in total, these agreements, in both oncology and other therapeutic areas, allow us to expand the breadth of our portfolio with access to cutting-edge research programs in a way that manages the risk of our internal portfolio. We've intentionally constructed a pipeline with a large number of programs in phase one and fewer derisked programs in phases two and three with the goal of creating a long-term, sustainable, productive pipeline to fuel our future.

Fewer de risk programs.

And phases, two and three with the goal of creating long term sustainable productive pipeline to fuel our future.

Turning to HIV I wanted to Echo Joanne his comments about the impact once the Liebig Harvey has.

For people living with HIV.

At the same time, we recognized some individuals prefer less frequent long acting regimens. We're excited about the potential of long acting antivirals and believe that our capsid inhibitor and Linda camera gear has a number of attributes that are important possibilities for both treatment and prevention.

Beginning with treatment people living with HIV tell us that either a weekly oral regimen or subcutaneous injection every three to six months are preferred regimens.

Merdad V. Parsey: Turning to HIV, I want to echo Johanna's comments about the impact one salivic tarvy has on people living with HIV. At the same time, we recognize that some individuals prefer less frequent long-acting regimens. We're excited about the potential of long-acting antivirals and believe that our capsid inhibitor, linacaprevir, has a number of attributes that have important possibilities for both treatment and prevention. Beginning with treatment, people living with HIV tell us that either a weekly oral regimen or a subcutaneous injection every three to six months are preferred regimens.

As we look at how we will combine <unk> with other agents and the potential dosing flexibility and blended <unk> offers possibilities to explore and clinical research both oral and subcutaneous administration.

We expect to identify and internally developed agent or an external partner to lend and copper per year to move into combination trials over the next 12 to 18 months.

This will complement our firsthand and camera gear FDA filing expected in the second half of this year for use and heavily treatment experienced individuals with HIV.

Now turning to prevention. We also believe there are many people for whom and subcutaneous injections, possibly as infrequently as once every six months could provide a significant advantage.

Merdad V. Parsey: As we look at how we'll combine Lenacaprivir with other agents, the potential dosing flexibility of Lenacaprivir offers possibilities to explore in clinical research, both oral and subcutaneous administration. We expect to identify an internally-developed agent or an external partner for Lenin-Capriver to move into combination trials over the next 12 to 18 months. This will complement our first Lenacaprivir FDA filing, expected in the second half of this year, for use in heavily treatment-experienced individuals with HIV. Now turning to prevention, we also believe there are many people for whom a subcutaneous injection, possibly as infrequently as once every six months, could provide a significant advantage.

And I'm pleased to share that we will begin a phase.

<unk> phase III studies, this year with land and <unk> as monotherapy for the prevention of HIV.

We are planning two phase III studies.

The first will be insist gender men transgender women and men and gender nonbinary people, who have sex with men.

And it will begin in the first half of 2021.

The second is and I will.

Listen girls and young women and that will begin in the second half of 2021.

Finally, I want to close with some commentary on the clearing our ongoing commitment to patients amid the COVID-19 pandemic.

Like so many others, we're encouraged to see the progress with the approval of the first vaccines and introduction of other therapeutics that.

That clearly continues to be a critical tool for patients and physicians and the fight against COVID-19.

Clinical data from.

From a randomized double blind placebo controlled NIAD AC TT one trial has established the efficacy and safety of room that severe.

The Gilead sponsored simple studies and real world patient and physician experience continues to support the critical role and that clearly is a standard of care and the treatment of hospitalized patients with COVID-19.

Merdad V. Parsey: I'm pleased to share that we'll begin Phase 3 studies this year with Lennon-Kaepferger as monotherapy for the prevention of HIV. We're planning two Phase 3 studies. The first will be in cisgender men, transgender women, and men, and gender non-binary people who have sex with men.

There clearly is the only anti vernalis and theres been approved or grants and temporary authorization for the treatment of COVID-19, and approximately 50 countries worldwide.

Merdad V. Parsey: That will begin in the first half of 2021. The second is in adolescent girls and young women, and that will begin in the second half of 2021. Finally, I want to close with some commentary on declaring our ongoing commitment to patients amid the COVID-19 pandemic. Like so many others, we're encouraged to see progress with the approval of the first vaccines and the introduction of other therapeutics. The Glory continues to be a critical tool for patients and physicians in the fight against COVID-19. Clinical data from the randomized double-blind placebo-controlled NIAID ACDT1 trial have established the efficacy and safety of remdesivir.

We welcome. The addition of new medicines that are helping to ease the burden and will continue to work to understand how best to use the <unk> and how to advance the use of <unk> and additional settings and formulations with the goal of treating additional patients who may benefit.

As Dan shared with you you can expect to hear from as often as we look ahead toward a number of exciting milestones.

Our growing pipeline means we hope to have more data to share and more news about regulatory filings, we're focused on delivering important transformative therapies to improve care for people with serious illnesses and I look forward to discussing the expansion of <unk> and Mcgraw and map data. The lumina copper grew milestones and the initiation of key phase III trials over the course of the year.

Now I'd like to open the call for questions operator.

Merdad V. Parsey: Gilead-sponsored simple studies and real-world patient and physician experience continue to support the critical role of the FLIRI as a standard of care in the treatment of hospitalized patients with COVID-19. Verclerc is the only antiviral medicine that has been approved or granted temporary authorization for the treatment of COVID-19 in approximately 50 countries worldwide. We welcome the addition of new medicines that are helping to ease the burden and will continue to work to understand how best to use Viclory and how to advance the use of Viclory in additional settings and formulations with the goal of treating additional patients who may benefit.

Thank you Sir as a reminder to ask a question you would need to press star one on your telephone to withdraw your question. Please press the pound key.

Please stand by while we compile the Q&A roster.

I show our first question comes from the line of Michael Yee from Jefferies. Please go ahead.

Hi, guys. Thanks, John.

Congrats on a great year.

My question is maybe for Andy or Dan when you think about the various uncertainties about growth and I think it's been a day of a controversy for gilead and a little bit muddied with declaring recently do you think about 2021 as a growth here into 2022 and put another way do you think that this is a trough period and you are.

Merdad V. Parsey: As Dan shared with you, you can expect to hear from us often as we look ahead toward a number of exciting milestones. A growing pipeline means we hope to have more data to share and more news about regulatory filings. We're focused on delivering important transformative therapies to improve care for people with serious illnesses, and I look forward to discussing the expansion of Tordelvie, the Macrolimab data, the linocaprogram milestones, and the initiation of key Phase III trials over the course of the year. Now I'd like to open the call for questions. Operator?

Very confident about growth off the share. Thank you so much.

Hey, Thanks, Michael I'll start and then <unk>.

Andy to provide a bit look I think you heard us at J P. Morgan I think we reiterate our confidence that the next chapter of Gilead is here that we.

And I'm very confident and our ability to grow the business.

And the top and bottom line, excluding the glory that doesn't belies, our confidence and declaring exists but of course and we're seeing it track.

Very well with hospitalizations and but.

But we also want to have and and we want you to have confidence and our ability to grow the underlying business. Excluding Macquarie. So yes, we're committed to that yeah, I think youll see that and the guidance that we delivered here today for 2021, and we're committed and and that's.

Operator: Thank you, sir. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, please press the pound key.

Operator: Please stand by while we compile the Q&A roster. I'll show our first question comes from the line of Michael Yee from Jefferies. Please go ahead. Hi guys, thanks, and congrats on a great year. My question is maybe for Andy or Dan.

And that's despite the fact that we are offsetting a significant amount of generic.

Erosion with a triple and Truvada so.

Obviously, as we head into 2022 and beyond.

Michael J. Yee: When you think about the various uncertainties about growth that I think have been a bit of a controversy for Gilead and a little bit muddied with that query recently, do you think about 2021 as a growth year into 2022? And put another way, do you think that this is a trough period and you're very, very confident about growth after this year? Thank you so much. Hey, thanks, Michael. I'll start and then add Andy to provide a bit. Well, look, I think you heard us at JP Morgan.

We don't have that headwind as well so I would pass it over to Andy for some additional comments as well from your side.

Yeah, Hi, Michael Thank you for the question and.

And your comments on the year.

The simple answer to your question is yes, and I think that we do see this as a really important year where.

We said at JP, Morgan and picking up on Dan's points.

And we expect to grow and the short term the medium term and the long run from here and we think we have all the puzzle pieces together that will allow us to do that.

Our guidance and you see and some of the pages that we tried to help people think through the core business and the materials that we posted and I would emphasize and focus people on that 9% and 10% growth and the core business, excluding the impact of the low <unk>.

Daniel O'Day: I think we reiterate our confidence that the next chapter of Gilead is here and that we are very confident in our ability to grow the business, um, in the top and bottom line excluding Vic Lurie. That doesn't belie our confidence in Vic Lurie, but of course, and we're seeing it track obviously very well with hospitalization, But we also want to have, and we want you to have, confidence in our ability to grow the underlying business So, yes, we're committed to that.

So we're going to grow through the low <unk> and then we think we should have some.

Additional momentum coming out of 2021 and two the subsequent years and.

And we also have a very capital efficient and inefficient corporate model as you know Michael So when you talk about kind of bottom line growth, we see a lot of potential for leverage is where we're driving topline growth to really expand the EPS growth over the coming years as well. So we're excited about where we are and and where we're going and look forward to update.

Daniel O'Day: I think you see that in the guidance that we delivered here today for 2021. And we're committed, and that's despite the fact that we are offsetting a significant amount of generic erosion with Tripla and Truvada. So, obviously, as we head into 2022 and beyond, we don't have that headwind as well.

And you throughout the year.

Makes sense. Thank you.

Thanks, Michael.

Thank you.

Sure. Our next question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead.

Great Good afternoon, and thanks for taking the question I guess.

Daniel O'Day: So, I would pass it over to Andy for some additional comments as well. Yeah, hi, Michael. Thank you for the question and your comments on the year.

Two part on like half of year for me. One can you can you talk a little bit and detail about what internal combinations you might be pursuing in terms of mechanisms and and how you might be able to give us some idea around when we might see some initial data on those and then second can you just talk about the dosing frequency and that youre going to be pursuing.

Andrew D. Dickinson: The simple answer to your question is yes, I think that we do see this as a really important year where, you know, we said at JP Morgan picking up on Dan's points, we expect to grow in the short term, in the medium term, and in the long run from here. And we think we have all the puzzle pieces together that will allow us to do that. You know, our guidance, and you see on some of the pages that we tried to help people think through the core business and the materials that we posted, and I would emphasize and focus people on the nine to 10% growth in the core business, excluding the impact of the LOEs. So we're going to grow beyond the LOEs.

<unk>.

In the monotherapy studies, you're going to look at six months only.

Or are you going to look at other frequencies for the prep study. Thanks.

Yeah, Thanks, Matthew I'm going to hand, it over to my dad, obviously, but just a couple of points to kind of frame. This I think there are two points I want to make one is gilead has prided itself on making sure we really understand what patients need out there.

Andrew D. Dickinson: And then we think we should have some, you know, additional momentum coming out of 2021 into the subsequent years. And we also have a very capital efficient and efficient corporate model, as you know, Michael. So when we talk about kind of bottom-line growth, we see a lot of potential for leverage as we're driving top-line growth to really expand EPS growth over the coming years as well. So we're excited about where we are and where we're going and look forward to updating you throughout the year. It makes sense.

Every step of the way for the past couple of decades, which led us obviously to the robustness.

Around <unk> is really the standard of care and the treatment setting.

And the Scobey and.

And.

We also pursue.

Our philosophy of having an anchor molecule and what we're really excited about with capsid and.

This presents the opportunity for our true anchor molecule.

Michael J. Yee: Thank you. Thanks, Michael. Thank you. I assure you our next question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead. Great. Good afternoon.

For.

For a long acting that meets patient needs.

And it needs that we think are really going to move potentially move some of the patients from a very convenient one pill once a day to a less frequent dosing and so I remind you that we've got lots of options with Atlanta cap of your and I'll turn it over to.

Matthew Harrison: Thanks for taking the question. I guess, two parts on Lena Kavavior for me. One, can you talk a little bit in detail about what internal combinations you might be pursuing in terms of mechanisms, and how you might be able to give us some idea around when we might..., www.kenhub.com um... in the monotherapy studies, you're gonna look at six months only, or you can look, Yeah, thanks, Matthew. I'm going to hand it over to Merdad, obviously, but just a couple of points to kind of frame this.

Mehrdad to go through some of those over to you and we're done.

Thanks, Dan.

Great question Matthew.

To your point, we haven't talked too much about it and look we have a number of internal assets.

John.

That we can combine with Atlantic cat per view, given the Atlanta and cap reviews, a capsid inhibitor. It gives us a lot of flexibility to look for what the second component could be there so ranging from things like big Tegra and tap to other things and our pipeline. We believe those can all internally form part of a combination.

Matthew Harrison: I think there are two points I want to make. One is, you know, Gilead has prided itself on making sure we really understand what patients need out there every step of the way for the past couple of decades, which led us obviously to the robustness around PICTARVI as really the standard of care and the treatment setting, and the SCOBY. And, you know, we also pursue a philosophy of having an anchor molecule.

And going forward.

We would anticipate that we will.

I'll start doing phase one studies this year and then data will follow from that in terms of what.

Matthew Harrison: And what we're really excited about with CAHPS is that it presents the opportunity for a true anchor molecule for long acne that meets patients' needs, the types of needs that we think are really gonna move, potentially move some of the patients from a very convenient one pill once a day to less frequent dosing. So I remind you that we've got lots of options with Lenacapavir, and I'll turn it over to Merdad to go through some of those. It is over to you, Merdad. Thanks, Dan. Great question, Matthew.

Which combination partner we would choose.

And the second part of your question, whether we would look only at six months.

I would say so.

It's important to think about lending cap revere, both having oral and.

Subcutaneous approaches so on the oral side, we think we can dose orally about once a week and so that could form one regimen that we would approach.

To go for a once weekly oral regimen.

Daniel O'Day: You know, to your point, we haven't talked too much about it. Look, we have a number of internal assets that we can combine with Lenin-CAP Revere. Given that Lenin-CAP Revere is a capsid inhibitor, it gives us a lot of flexibility to look for what the second component could be there.

For for sub Q, it will partly depend on what what the combination molecule would be and what dosing interval, we can get with that we'd certainly like to target six months, but.

And if necessary we can go to every three months or something like that so it will it will really depend on what the what the partner is the key issue here is that we have a lot of flexibility with with <unk> and and it gives us a lot of options to sort of see how and how we can market and thats and thats where were going to go.

Merdad V. Parsey: So, ranging from things like Bic-Tag Revere and TAP to other things in our pipeline, we believe those can all internally form part of a combination regimen going forward. We would anticipate that we'll start doing phase one studies this year, and then data will follow from that in terms of which combination partner we would choose. On the second part of your question, whether we would look only at six months, I would say, you know, it's important to think about Lenin-Caprivir both having oral and subcutaneous approaches. So on the oral side, we think we can dose it orally about once a week, and so that could form one regimen that we would approach to go for a once-weekly oral regimen.

And the last thing I'd say is for prep.

And as I mentioned the ones that are getting started are going to be every six months. So that is the regimen, we're using footprint.

Thank you can we have the next question. Please.

Thank you. Our next question comes from the line of Alicia Young from Cantor. Please go ahead.

Hey, guys. Thanks for taking my question and congrats on everything that you've done over the past 12 months.

And I kind of wanted to stay with what type of are a little bit and you know it seems like there and the robust backbone potential and I guess I wanted to get your perspective on the potential opportunity to grow the market.

Merdad V. Parsey: For sub-Q, it'll partly depend on what the combination molecule would be and what dosing interval we can get with that. We'd certainly like to target six months, but if necessary, we can go to every three months or something like that. So it'll really depend on what the partner is. The key issue here is that we have a lot of flexibility with Lenin-Caprivir, and it gives us a lot of options to sort of see how we can work it, and that's where we want to go.

From where you are and since you could possibly use offense, both treatment and prevention or do you kind of see it more like an opportunity for switches and if so like what drugs do you think the <unk> switches.

Essentially likely thing thanks.

Yes, thanks, Alicia thanks for the comment.

Joanna and her team have done a lot of work on this I'll, let her start and see if anybody else and does he want to add over to you John.

Thanks, Dan Hi, Lee Yeah. Thanks for the question.

Merdad V. Parsey: And the last thing I'd say is for PrEP, the studies I mentioned, the ones that are getting started, are going to be every six months. So that is the regimen we're using. Thank you. Can we have the next question, please? Thank you. Our next question comes from the line of Aletheia Young from Canthar.

I think that the.

And we're looking at it and all.

I'll start with actually the first filing right, which is heavily treatment experienced.

And is expected to file to point, the and this year and.

Aletheia Young: Please go ahead. Hey guys, thanks for taking my question and congrats on everything that you've done over the past 12 months. I kind of wanted to stay with Lenacaprevir for a little bit.

I think that one for us and it's really an opportunity to go into the market Capex you need to get additional experience with Atlanta cap with you and kind of create that foundation for Atlanta and.

Daniel O'Day: And, you know, there seems like there's a robust backbone potential, and I guess, you know, I wanted to get your perspective on the potential opportunity to grow the market from where you are, since you could possibly use this in both treatment and prevention. Or do you kind of see it more like an opportunity for switches, and if so, like, what drugs do you think Tarvy switches are a potentially likely thing? Yeah, thanks, Alethea. Thanks for the comment. Johanna and her team have done a lot of work on this, so I'll let her start and see if anybody else on the team wants to add anything.

And I would split up the question between treatment and crap I think and Streetman the expectation that the market will continue to grow at 3% that we've been seeing year over year.

And so I think it'll be more of a a little bit of a switch from oral to long acting within the treatment I think the real opportunity for expansion with long actings will be and the prevention market.

We've said before that that we've only and.

Scratched the surface at about 2025% of the total market today, Inc.

<unk>, which I'm not sure that <unk> I think the opportunity really to expand that market with long actings that would make it much more flexible for people.

Johanna Mercier: Over to you. Thanks, Dan. Hi Olivia.

Johanna Mercier: Thanks for the question. I think that the way we're looking at it, and I'll start with actually the first filing, right, which is heavily treatment experience, which is expected to file towards the end of this year. I think that one for us was really an opportunity to go into the market, a fast opportunity to get physician experience with Lenacapavir and kind of create that foundation for Lena. I would split up the question between treatment and PrEP.

And so I think that's it actually expansion strategy.

Net and treatments.

Great. Thank you.

Thanks. Good evening. Thank you can we have and the next question.

Our next question comes from the line of Brian Abrahams from RBC capital markets. Please go ahead.

Hi, there. Thanks, so much for taking my question and congrats and all the progress I am interested in learning more about the upside and use you might expect and yes, Carter with <unk> second line readout and I guess I'm curious how much of current any current hurdles are related to complexity of administration and the pandemic versus the labeled indication and available data and when you.

Johanna Mercier: I think in treatment, the expectation is the market will continue to grow at the 2-3% that we've been seeing year over year. And so I think it'll be more of a little bit of a switch from oral to long acting within the treatment. I think the real opportunity for expansion with long-acting agents will be in the prevention market. We've said before that we've only scratched the surface at about 20-25% of the total market today in prevention with Truvada and Discozy. I think the opportunity really is to expand that market with long acting. That would make it much more flexible for folks, and people at risk of HIV.

You get the Zuma seven data what are some of the pushes and pulls with respect to efficacy and safety that would guide how you'd look at the future growth opportunity and car T.

Terrific.

Thanks, Brian for that I mean, we're very enthusiastic about the potential for years Garda and Altria, obviously, the second line readout and Christy is on the line. So I'll, let her breakdown the different pieces of that for you between.

Johanna Mercier: And so I think that's a true expansion strategy, but more in prevention than in treatment. Great. Thank you. Thank you. Can we have the next question? Our next question comes from the line of Brian Abrahams from RBC Capital Markets. Please go ahead. Hi there, thanks so much for taking my question and congrats on all the progress. I'm interested in learning more about the upside and use you might expect in Yaskarta with the DLBCL second-line readout, and I guess I'm curious how much of any current hurdles are related to complexity of administration and the pandemic versus the labeled indication and available data, and when you do get the Zuma 7 data, what are some of the pushes and pulls with respect to efficacy and safety that would guide how you'd look at the future growth opportunity in CAR-T?

Covid and non Covid and some of the dynamics so over to you Christy.

Sure. So overall from a total cell therapy.

<unk> grew 33% year over year.

And when you look at <unk> it is.

Externally.

And the U S and what we call <unk>, which is Europe, Canada and Australia.

And also in the U S to Carlos is growing significantly above our expectations and the dynamic in the U S spring and SCADA and.

Couple of fold out and as we saw with our <unk>.

And other car car T.

Therapies on the Mark at the Clos overall has declined from 23% to 20% which is significant and.

And Q4 and the reason for that is referrals are down because of Covid, obviously, and that's driving the majority of it and also lack of ICU beds.

And the lack of ICU beds disproportionately affect with garlic, and where the majority of our sales are and the inpatient side. So as we look at what specifically not just COVID-19 overall, but you dig down and under what is COVID-19, yet the referral aspect and the community.

Brian Abrahams: Thanks. Terrific. Well, and thanks, Brian, for that. We're very enthusiastic about the potential for Yoskarta. And obviously, the second line readout, and Christy's on the line.

Physicians aren't seeing patients patients aren't going into the offices and then you'll also have at the ACC and the issue of ICU bed capacity and warehouse can you.

I think those patients.

So overall, it's the biggest driver and class share decline and secondarily is the a little bit of the product sales based on the ICU beds.

Daniel O'Day: So I'll let her break down the different pieces of that for you between COVID and non-COVID and some of the dynamics. So, over to you, Chris. Sure, so overall from a total self-therapy performance, we grew 33% year-over-year. And as you look at Yaskarta, it's growing externally, outside the U.S. in what we call ACE, which is Europe, Canada, and Australia. And also in the US, Ticardus is growing significantly above our expectations. The dynamic in the US for Yscarta is two-fold.

And that helps to answer the question.

Brian do you have something else.

Great. Thank you.

Thank you.

Our next question comes from the line of Geoffrey Porges from SVP Leerink. Please go ahead. Thank.

Thank you very much and.

And just down slightly.

And as housekeeping questions first Andrew.

And could you just give us a sense of what your share count guidance is for 2021.

And secondly.

Could you tell us whether you are seeing any.

And destiny and resistant variants emerging on day one.

And I'm definitely be effective against.

Barry and stuff that's been identified already and then lastly.

Daniel O'Day: As we saw with our other CAR T therapies on the market, the class overall has declined from 23% to 20%, which is significant in Q4. And the reason for that is referrals are down because of COVID, obviously, and that's driving the majority of it. And also a lack of ICU beds.

And could tell us why shouldn't we look at the buy and two office.

And as a positive indicator for your expectations for one of the upcoming Readouts.

Why would you have done that if you didn't what positively inclined to those events.

Hey, Thanks, Jeff So and.

Andy why don't you start with that and I'll bring it home.

Chris: The lack of ICU beds does disproportionately affect Yaskarta because the majority of our sales are on the inpatient side. So as we look specifically at what specifically, not just COVID overall, but you dig down into what COVID is, you have the referral aspect when community physicians aren't seeing patients, and patients aren't going into the offices. And then you also have at ATCs the issue of ICU bed capacity and where else can you treat those patients.

Hi, Jeff Good afternoon, and the share count, we're assuming a flat share count year over year, so to be to be clear. The EPS guidance is not being driven by share buybacks or share count and so our base assumption is that we will just redo repurchases to offset employee stock issuance over the year.

We maintain obviously the flexibility.

To opportunistically repurchase more shares if we conclude over the year. That's a good use of our capital but right now the base case is that we will just repurchase shares to offset employee share.

Chris: So overall, the biggest driver is the class share decline. And secondarily, is a little bit of product sales based on the ICU. Does that help answer the question? Brian, do you have something else?

Share issuance.

Great. Thanks, and then.

As Mark just a follow up on your question on the resistance. So as you know most of the resistant most of the.

Brian Abrahams: Okay, great. Thank you. Thank you. Our next question comes from the line of Geoffrey Porges from SVB Leering. Please go ahead. Thank you very much. Healthkeeping questions first.

Variance that have.

Popped up or in the spike protein and Thats been the source of the problem, which is why people are talking about sort of the.

Geoffrey Christopher Meacham: Andy, could you just give us a sense of what your share count guidance is? Secondly, Merdad, could you tell us whether you're seeing Remdesivir-resistant variants emerging, and whether Remdesivir is active against... variants that have been identified already? And then, lastly, perhaps Dan could tell us, why shouldn't we look at the buy-in to our? as a positive indicator for your expectations for one of the upcoming readouts? Why would you have done that if you weren't positively inclined to them?

And the vaccine issues and potentially the monoclonal antibodies because they are directed to this spike but from that severe targets. The RNA polymerase. So in our case, so far with the variance.

And I'm asking a question.

Excuse me.

Sorry.

Sorry for the interruption so.

For the four and they are.

RNA polymerase, we haven't seen so far.

That would impact the efficacy of <unk> at least when we're looking at the sequences. So so.

Andrew D. Dickinson: Hey, thanks, Geoff. So Andy, why don't you start Merdad, and I'll bring us home. Hi Geoff. Good afternoon. On the share count, we're assuming a flat share count year over year. So to be clear, the EPS guidance is not being driven by share buybacks or share counts. So our base assumption is that we will just do repurchases to offset employee stock issuance over the year. But we maintain, obviously, the flexibility to opportunistically repurchase more shares if we conclude over the year that that's a good use of our capital. But right now, the base case is that we will just repurchase shares to offset employee share issuance. This is Merdad.

And so far knock wood.

We haven't seen anything starting today and kind of just a follow up have you have you see.

<unk> any individuals who failed, but I'm guessing here to see if there's any resistance and the virus.

We have not to my knowledge okay. Thanks.

And Jeff just bringing it home I think that's a bit of a double negative questionnaire and we put it into a positive I think you can read into our continued investment and arcos.

Yes.

US viewing the entirety of their portfolio is attractive right now and not any one asset but I'll.

Merdad V. Parsey: Just to follow up on your question on the resistance. So, as you know, most of the variants that have popped up are in the spike protein. And that's been the source of the problem, which is why people are talking about sort of the vaccine issues and potentially the monoclonal antibodies, because they're directed at the spike. But remdesivir targets the RNA polymerase.

And just mentioned a couple of course and the ticket space.

There are potentially two different mechanisms, but as you know, both and FC and a non FC receptor.

There's a variety of adenosine programs, there's the PD one.

And there's a variety of earlier stage programs. So I think you're absolutely right two to see the additional investment.

Merdad V. Parsey: So in our case, so far with the variants that have come, Excuse me. Sorry. Sorry for the interruption. So for the RNA polymerase, we haven't seen so far mutants that would impact the efficacy of remdesivir, at least when we were looking at the sequences.

As an additional.

You know confidence and the science and frankly, the people that aren't because and we're very very pleased with.

The way, we're cooperating and collaborating and couldn't be more seamless and the opportunity I think to think of.

Merdad V. Parsey: So, so far, knock wood, we haven't seen anything. Sorry, can I just follow up, have you sequenced any individuals who failed remdesivir to see if there's any resistance in the virus? We have not, to my knowledge.

Mr. Daniel joined momentarily.

Sorry can you hear me now.

Yes.

Okay and do something.

And question Geoff I was just going to emphasize and additions DRP portfolio.

Combination potential with our other agents we are really excited about the potential to think about two possibly three drug combinations between what we have within our gilead portfolio today, the ARCUS portfolio and other options, but we have now and.

Daniel O'Day: And, Geoff, just bringing this home, I think, you know, it's a bit of a double negative question. Let me put it into a positive. I think you can read into our continued investment in ARCIS as us viewing the entirety of their portfolio as attractive, right? Not any one asset, but I'll just mention a couple. Of course, in the tiget space, there are potentially two different mechanisms, as you know, both an FC and a non-FC receptor.

And in the future. Thanks, Jeff Alright, Thank you.

Yeah.

Thank you.

Our next question comes from the line of Robin <unk> from <unk>. Please go ahead.

Hi, Thanks for taking my question.

And the tier ones, I mean, one and ARCUS and arc seven I mean, obviously, if the triple works that's game changing and you wanted the few companies that has the triple.

Daniel O'Day: There's a variety of Adenosine programs, there's the PD-1, and there's a variety of earlier stage programs. So I think you're absolutely right to see that additional investment as an additional confidence in the science and, frankly, the people at Arcus. And we're very, very pleased with the way we're cooperating, collaborating, couldn't be more seamless. And the opportunity, I think, to think, so they will join momentarily. Oh, okay. Sorry, can you hear me now?

And and I was.

And just thinking about the amount of trials he might want to begin at that point. So talk to me a little bit about how you're thinking about margin and maintaining margins with so many trials that you might want to begin and the robustness of that and then also talk to me about <unk>.

Do you have a perspective on the likelihood of that.

Combination of Triple combination working versus the doublet because other people have the topline. So just getting your perspective on the confidence you have and then also on thinking about all these trials that you may want to begin and and if you can maintain some sort of give us some sense of margins and R&D expense going and the out years. Thanks.

Daniel O'Day: Yes, I can. Okay, I'll just finish up on the question, Geoff. I was just going to emphasize, in addition to the ARCIS portfolio, the combination potential with our other agents. We're really excited about the potential to think about two, possibly three drug combinations between what we have within our Gilead portfolio today, the ARCIS portfolio, and other options that we have now and in the future. Thanks, Geoff.

Hey, Robyn, it's Andy let me start with the last day and again I'm sorry, let me start with the margin question. So.

Not providing longer term guidance, but and we have flexibility and the way that we've structured the deals as you know so.

And until we opt in the R&D expense.

Robin Knauskaus: Thank you. I show our next question comes from the line of Robin Knauskaus from Truist. Please go ahead. Hi, thanks for taking my question. Um, two ones.

And is borne by by ARCUS as with many of our partnerships.

Obviously, we're planning for success and looking at our R&D expense and the future and making sure that we have the flexibility and Rick.

Andrew D. Dickinson: I mean, one on ARCIS and ARC-VII. Obviously, if the triple works... That's game changing. I mean, you're one of the few companies that has the triple. And I was just thinking about the number of trials that you might want to begin at that point. So, talk to me a little bit about how you're thinking about margins and maintaining margins with so many trials that you might want to begin and the robustness of that.

Capital structure and otherwise to push these programs forward its a data.

Supports it and we have a lot of leverage and our models and we again are very strong margins at a high level Robin what I'd say is we don't expect that any of the opt ins and less unless were really opting into all of the programs across the board that we have options on would fundamentally change our margin profile and if they did.

Andrew D. Dickinson: And then also talk to me about it. Do you have any perspective on the likelihood of the triple combination working versus the doublet? Because other people have the doublet, so just getting your perspective on the confidence you have and then also on thinking about all these trials that you may want to begin and, if you can maintain some sort of, give us some sense of margins and R&D expenses going forward in the years ahead. Hey Robin, it's Andy.

That would be and the short term.

And potentially a good problem to have so we're really comfortable with the structure that we have where we are with our margin today, where we see them going we like our R&D load today in terms of the amount of scale, we have added to our R&D programs.

And our spend levels you see that we're going to work very hard to.

Merdad V. Parsey: Let me start with the, we lost Dan again. I'm sorry. Let me start with the margin question. So we're not providing longer-term guidance, but we have flexibility in the way that we structured the deals, as you know. So, until we opt in, the R&D expense is borne by Arcus, as with many of our partnerships. Obviously, we're planning for success and looking at our R&D expenses in the future and making sure that we have the flexibility in our capital structure.

Manage our expenses thoughtfully with our team so from our vantage point, we're in a good spot and we hand, it over to Tim or data on the.

Clinical question Yeah.

It's a great observation and I think one of the things we really appreciate about the team at arc is is they're really focused on two things with with the tissue.

Asset and particular, one is too.

And to try to be as fast as possible.

Merdad V. Parsey: And otherwise, to push these programs forward if the data supports it, and we have a lot of leverage in our model. So we, again, have very strong margins. At a high level, Robin, what I'd say is we don't expect that any of the opt-ins, unless, you know, unless we're really opting into all of the programs across the board that we have options on, would fundamentally change our margin profile. And if they did, obviously, that would be, in the short term, potentially a good problem to have.

Taking the appropriate kinds of risks to make sure that we are really in the hunt and.

And I think what's exciting there is a possibility to be potentially second to market with.

With that asset and secondly to look at.

Combinations within the portfolio to look for evidence is even better activity that could really position us uniquely and out there. So.

Robin Knauskaus: So we're really comfortable with the structure that we have, where we are with our margins today, and where we see them going. We like our R&D load today, in terms of the amount of scale we've added to our R&D programs. And our spend levels. You can see that we're going to work very hard to manage our expenses thoughtfully with our team. So from our vantage point, we're in a good spot. Let me hand it over to Mehrdad on the clinical question. Yeah, it's a great observation.

Getting back to the earlier question about.

ARCUS and our.

Our relationship there and Theyre very impressive group and have been doing great work. So we're excited to see how those data play out.

Thanks, Congrats on the on the on the year. Thank you. So much. Thank you. Thanks, Robin Thanks, Marta and thanks Hendi.

Next question please.

Our next question.

Merdad V. Parsey: And I think one of the things we really appreciate about the team at Arcus is they're really focused on two things with the TIGIT asset, in particular. One is to try to be as fast as possible, taking the appropriate kinds of risks to make sure that we are really in the hunt, that we, and I think what's exciting there is the possibility to be potentially second to market with that asset. And secondly, to look at combinations within the portfolio to look for evidence of even better activity that could really position us uniquely out there.

Comes from the line of Cory <unk> from JP Morgan. Please go ahead.

Hey, good afternoon, guys. Thanks for taking my question I was wondering if you could talk a little bit more about the latest trends youre seeing and the prep market today and how we should be thinking about that are really thinking about <unk> going forward and in the face of Truvada generics, especially given that it wasn't and you're more granular sales guidance slide either.

Corey Casimo: So getting back to the earlier question about Arcus and our relationship there, they're a very impressive group and have been doing great work. So we're excited to see how the data play out. Thanks. Congratulations on the year. Thank you so much.

Is it like a headwind or tailwind. Thank you very much.

Hey, Thanks, Cory Yeah, Joanna over to you. Please.

Thanks for the question.

Yeah, So as I mentioned.

Earlier, this year and he's been actually quite stable. So what we've seen is really with.

Daniel O'Day: Thank you. Thanks, Robin. Thanks, Merdad. Thanks, Andy.

And with Nevada, Lee, what we've seen is a little bit and mix within <unk> bought out between branded and generic.

Johanna Mercier: Can we have the next question, please? Our next question comes from the line of Corey Casimo from J.P. Morgan. Please go ahead. Hey, good afternoon, guys.

But we haven't seen that impact the scoping and all.

And I'm, sorry, John that at that level of share and we expect that to continue to basically be anywhere between 40, and 45 percentage or so throughout the year, having said that we did see a little bit of a decline quarter over quarter about 6% or sales and that was largely due to the contracting to maintain a strong commercial access.

Corey Casimo: Thanks for taking my question. I was wondering if you could talk a little bit more about the latest trends you're seeing in the prep market today and how we should be thinking about that, or really thinking about just SCOBY going forward in the face of Truvada generics, especially given that it wasn't in your more granular sales guidance slide, either as a headwind or a tailwind. Thank you very much. Hey, thanks, Corey. Yeah, Johanna, over to you, please.

And the one difference has been much more around because.

It hasn't been convention and it's highly commercially commercial payers and so therefore, we're really quite focused and just making sure that that people that.

Umer Raffat: Thanks, Corey, for the question. Yeah, so as I mentioned earlier, the share has actually been quite stable. So what we've seen is really with Truvada LOE, there is a little bit of mix within Truvada between branded and generic. But we haven't seen that impact on the SCOBY at all.

<unk> assets to just go the in light of the strong profile safety profile that it offers and so did we definitely seen erosion with two bought US John erosion in Q4 and that will continue and we think about coming quarters. This year, but really from a discovery standpoint, the expectation is that we continue to.

Merdad V. Parsey: On the contrary, it stayed strong at that level of share, and we expect that to continue to basically be anywhere between 40% and 45% or so throughout the year. Having said that, we did see a little bit of a decline quarter over quarter, about 6% or so. And that was largely due to the contracting to maintain strong commercial access.

And maintain strong commercial access and obviously that might mean.

And then a little bit more contracting a little bit more just gone out and that runs about.

And that's important for us to make sure that people living with type assets to the study and we continue so hopefully that kind of addresses your question on current market Yeah definitely very helpful. Thanks for the color.

Merdad V. Parsey: So the one difference has been much more around, because it's PREP, because it's in prevention, it's highly commercially commercial payers. And so therefore, we're really quite focused on just making sure that people at risk have access to SCOBY in light of the strong profile and safety profile that it offers. And so we've definitely seen erosion with Truvada, strong erosion in Q4.

Thank you so much and we have the next question.

Thank you and our next question comes from the line of Omar <unk> from Evercore. Please go ahead.

Hi, Thanks, so much for taking my question I have two if I may 1st perhaps on <unk> I know, there's the HR positive phase III coming up and breast and my question was that originally the protocol allowed for an interim or our analysis to support an accelerated approval.

Umer Raffat: And that will continue as we think about the coming quarters this year. But really, from a SCOBY standpoint, the expectation is that we continue to maintain strong commercial access. And obviously, that might mean a little bit more contracting, so a little bit more discount on that front.

I'm curious, if that's still happening and the first half.

Terence Flynn: But one that's important for us to make sure that people living at risk have access to the SCOBY as we continue forward. So hopefully, that kind of addresses your question about the PREP market. Yeah, definitely. Very helpful. Thanks for the...

And secondly, I'm curious what the observations are to date from the inhaled room death severe as phase one being early COVID-19 and I'm, mostly wondering given the ongoing epidemic and it gives.

And the ongoing pandemic as well as given all the phase III safety data wouldn't the phase one b data form the basis for a potential <unk> along with the safety data that exists. Thank you very much.

Johanna Mercier: Thank you so much. Can we have the next question? Our next question comes from the line of Umer Raffat from Evercore. Please go ahead. Hi, thanks so much for taking my question. I have two, if I may. First, perhaps on TRODELV. I know there's the HR-positive Phase 3 coming up in breast cancer, and my question was that, originally, the protocol allowed for an interim ORR analysis to support an accelerated approval. I'm curious if that's still happening in the first half.

Thanks humor for those questions appreciate it mehrdad, please and both of those.

Sure.

So on the <unk> you are right that there was.

Our plan or our.

And but we don't think that the <unk>.

And our evaluation of the interim analysis was actually going to form this.

Merdad V. Parsey: And secondly, I'm curious what the observations are to date from the inhaled remdesivir's Phase 1b trial in early COVID. And I'm mostly wondering, given the ongoing epidemic, given the ongoing pandemic, as well as given all the Phase 3 safety data, wouldn't the Phase 1b data form the basis for a potential EUA along with the safety data that exists? Thank you very much. Thanks, Umer, for those questions. I appreciate it. Merdad, please, on both of those.

The substantive enough data to get an approval and HR positive so.

What we did is we we looked initially at the study when as part of the evaluation together with the team in Immunomedics, We resize study two powered appropriately for overall survival and at the end of the year will readout PFS, which we think has a much better opportunity for reading out.

And giving us a fee.

<unk> and point so.

Merdad V. Parsey: Sure. So, on the TRDEL-V, you're right that there was a planned ORR, but we don't think that the ORR evaluation, the interim analysis, was actually going to form substantive enough data to get an approval in HR positive. So, what we did is we looked initially at the study as part of the evaluation together with the team at Immunomedics. We resized the study to power it appropriately for overall survival, and at the end of the year, we'll read out PFS, which we think has a much better opportunity for reading out and giving us a fileable endpoint.

So I think that was really the.

Our conclusion was essentially that the IRR was only just going to cost us alpha, but not really get us something that we could file with.

And we have not unblinded any data we don't it was not based on anything other than wanting to get to the PFS. So.

On the inhaled and best severe.

It's going well.

That study is moving through.

Phase one and has moved to move forward nicely and.

No.

The phase one study is probably not adequate for now probably is not adequate for approval.

When you move from parenteral too and inhaled approach, it's effectively moving it to a drug device combination approach and so all of the issues there.

Merdad V. Parsey: On the inhaled remdesivir, it's going well. That study is moving through Phase I and has moved forward nicely. And, no, the Phase I study is probably not adequate for—not probably—is not adequate for approval. It's a—when you move from parenteral to an inhaled approach, it's effectively moving it to a drug-device combination approach. And so, all the issues there—you know, a PK bridge is usually when you can show that the exposure is the same, but since the exposure will be very different systemically, it will be—primarily, the exposure will be in the lung. You can't do a bridging for PK.

Our PK bridge is usually when you can show that the exposure is the same but since the exposure will be very different systemically.

It will be primarily the exposure will be and the lung.

Can't do you can't do a bridging for PK. So it ends up being a clinical efficacy question as opposed to just a PK question. So the studies are designed to.

Will be designed to go forward with.

Evidence of clinical efficacy for approval.

Thank you so much.

Thank you Mort Doug and.

Andy I know, we're kind of a time should we try to take one or two more questions.

Terence Flynn: So, it ends up being a clinical efficacy question as opposed to just a PK question. So, the studies are designed to—you know, will be designed to go forward with evidence of clinical efficacy for approval. Thank you so much.

Yes, Dan I think we thought we'd take two more questions.

Excellent. Okay. Thank you can we have the next question. Please.

Sure. Our next question comes from the line of Terence Flynn from Goldman Sachs. Please go ahead.

Hi, Thanks for taking the questions I was just wondering if you can comment at all about breadth of prescribing with true Delphi what Youre currently seeing out there how you expect that to change over the course of the year and then the randomized lung cancer trial that you mentioned or that would that be a phase two or phase III trial and.

Andrew D. Dickinson: Thank you, Merdad. Andy, I know we're kind of on time. Should we try to take one or two more questions?

Daniel O'Day: Yeah, Dan, I think we'll, we thought we'd take two more questions. Excellent. Okay, thank you.

Operator: Could we have the next question, please? Sure, our next question comes from the line of Terence Flynn from Goldman Sachs. Please go ahead.

And then just one for Andy on the expense cadence in 2021.

That looks like if you were to exclude kind of underlying room test of your spend thank you.

Phil Nadeau: Hi, thanks for taking the questions. I was just wondering if you could comment at all about the breadth of prescribing with Tredelphi, what you're currently seeing out there, and how you expect that to change over the course of the year. And then the randomized lung cancer trial that you mentioned, Merdad, would that be a phase two or phase three trial? And then just one for Andy on the expense cadence in 2021, what that looks like if you were to exclude some kind of underlying remdesivir. Really good questions.

Really good questions. Thanks for those tenants will start with Joanna and then we'll go to them or data and long and then Andy on expense So Joanna.

Thanks, Darren and.

Yeah. So I think we're really pleased to see.

The evolution and Philadelphia right, it's only eight months and so they haven't had a full year, yet and and what we're seeing.

In 'twenty and 'twenty is very encouraging as of last October and more than one out of four patients where net.

And it onto modality in third line metastatic triple negative breast cancer.

Johanna Mercier: Thanks for those, Terence. We'll start with Johanna, and then we'll go to Merdad and Lon. Thanks. So go ahead, Johanna.

What we also were seeing and in.

In December one when conditions were actually ask sort of a point their own subsiding, a little bit of that HEU type approach.

Merdad V. Parsey: Okay, thanks Terence. Yeah, so I think we're really pleased to see the evolution of TRODELV, right? It's only eight months in, so they haven't had a full year yet. And what we're seeing in 2020 is very encouraging. As of last October, more than one out of four patients were initiated on TRODELV in third-line metastatic triple negative breast cancer.

Were you, suggesting somewhere in north of 40%.

Third line metastatic triple negative breast cancer patients were receiving <unk> and so we're seeing a nice uptake I think we have an opportunity to continue that uptake at Lee.

Think about expanding not only in the academic centers, but also with our community providers and I think that the opportunity as we think.

Merdad V. Parsey: What we also are seeing is in December, when physicians were actually asked to report their own prescribing, so a little bit of an APU-type approach, they suggested somewhere north of 40% of their third-line metastatic triple negative breast cancer patients were receiving TRODELV. And so we're seeing a nice uptake. I think we have an opportunity to continue that uptake as we think about expanding, not only in the academic centers but also with our community providers.

In the next and next little while and I think that will be driven mostly with the fact that we'll be able to promote the overall survival data and with the FDA approval and pull it.

For the ascend data and applications all of those things will be important inflection points for assets. He moves forward, but we're very excited and.

And as we see physicians and that are really getting physician feedback around making sure that they can get through their second line option pretty quickly to get to third line and we have very strong payer support as well and reimbursement. So theres been no barriers on that sense, either kind of a good shape. So far I'll turn it over to merit out on the lung cancer.

Merdad V. Parsey: And I think that's the opportunity, as we think in the next little while, and I think that'll be driven mostly by the fact that we'll be able to promote the overall survival data soon with the FDA approval, the full approval for the assent data, and the publication. So all of those things will be important inflection points for us as we move forward. But we're very excited as we see physicians and are really getting physician feedback around, making sure that they can get through their second-line options pretty quickly to get to third-line. And we have very strong payer support as well in reimbursement, so there's been no barriers on that front either. So, it's in good shape so far. I'll turn it over. Kim Murdat on lung cancer.

Question.

Yes.

So just to be clear, maybe I'll just say both so the study I was referencing that will readout for PFS as a hormone receptor positive. Her two negative study that has a phase III study.

And for lung cancer right now it's a day.

As I studied the tropics <unk> study is a phase I basket trial.

And pending those data we would.

Plan is that we would.

Open a phase III trial in lung cancer, and the second half of the year.

And Terence it's Andy on your last question, we haven't provided specific ex.

Merdad V. Parsey: Yeah, I think, so just to be clear, maybe I'll just say both. So the study I was referencing that will read out for PFS as a hormone receptor positive for two negative study, that is a phase three study. For lung cancer, right now, it's a phase one study; the Tropics three study is a phase one basket trial. And pending those data, our plan is that we would open a phase three trial in lung cancer. In the second half of the year. And Terence, it's Andy.

<unk> guidance on any of our products as you know.

What we've said on Rem density or is there still will be a meaningful amount of expenses and 2021 as you would expect but the expense load is lower than it was in 2020, so and we're not providing more specific guidance, but it's real it's important we continue to see the significant potential for the product for patients.

So we're continuing to invest appropriately and it is baked into our guidance, but it's.

Merdad V. Parsey: On your last question, we haven't provided specific expense guidance on any of our products. As you know, what we've said about remdesivir is that there still will be a meaningful amount of expenses in 2021, as you would expect, but the expense load is lower than it was in 2020. So, and we're not providing more specific guidance, but it's real. It's important.

It is a reduction year over year.

Thanks, So much Andy So we'll take one more question. Please.

Thank you. Our last question comes from the line of Phil Nadeau from Cowen and company. Please go ahead.

Good afternoon, and thanks for fitting me in and congrats on the progress just two follow up questions for me first for Joanna on discover you suggested that maybe theres, a little price compression because of renegotiations with commercial plans with the availability of Truvada generics.

Andrew D. Dickinson: We continue to see the significant potential for the product for patients. So, we're continuing to invest appropriately. And it is baked into our guidance, but it is a reduction year over year. Thanks so much, Andy.

And we're doing our modeling should we expect another round of negotiations after more generics enter and Q2 and could that.

Daniel O'Day: So we'll take one more question. Thank you. Our last question comes from the line of Phil Nadeau from Cowan & Company. Please go ahead.

Impact price and the second half of 'twenty 'twenty, one and then.

A question for you on <unk>.

A follow up on that.

Phil Nadeau: Good afternoon, thanks for fitting me in and congratulations on the progress. I have just two follow-up questions for you. First, for Johanna, on DSCOVI, you suggested that maybe there's a little price compression because of renegotiations with commercial plans because of the availability of a Travada generic. As we're doing our modeling, should we expect another round of negotiations after more generics enter the market in Q2, and could that impact prices in the second half of 2021? And then Merdad, a question for you on Tredelby, just to follow up on that phase three lung cancer study. I believe this is the first time we've heard about it. You're kind of committing to moving forward there. What gave rise to that?

Phase III lung cancer study I believe this is the first time, we've heard share.

And kind of committing to moving forward.

There what gave rise to that as the data you're seeing from the basket study or something you saw at world lung and what do you need to see from tropics <unk> three in order to just stick with that plan. Thank you.

Great. Thanks, Phil So Joanna and then we're done and then I'll just have a quick close.

Great. Thanks for the question, Yes, it's exactly what you described I think we're going be very joyful and obviously it needs to make sense, but there could be continued pressures.

And I think we see many of them and we've been managing it.

And as best we can to make sure that people are living out we still have access to discuss.

Johanna Mercier: Is it data you're seeing from the basket study or something you saw at WorldLong? And what do you need to see from Tropics 03 in order to stick with it? Hey, thanks, Phil. So Johanna and then Merdad, and then I'll just have a quick hug. Yeah, so exactly what you've described. I think we're gonna be very choiceful, and obviously, it needs to make sense, but there could be continued pressures. I think we've seen many of them, and we've been managing them as best we can to make sure that people living at risk still have access to Dyscovia, as it really is quite differentiated.

And it really is quite differentiated I think as you think about your models for 'twenty and 'twenty, one and there's two pieces. One is and you know the market intervention was quite depressed because of the pandemic and we started to see at <unk>.

Out of it and Q3, but of course and Q4 with a surge of cases and hospitalization and we saw that dampening again, assuming that we come back to some new normal. This year, we should see that market pick up again, so between the market pick ups as well as some continued smaller price contractions I think those two things will balance each other out.

Johanna Mercier: I think as you think about your model for 2021, there are two pieces. One is, as you know, the market for prevention was quite depressed because of the pandemic, and we started to see us coming out of it in Q3, but, of course, in Q4, with the surge of cases and hospitalization, we saw that dampening again. Assuming that we come back to some new normal this year, we should see the market pick up again. So between the market pick up, as well as some continued smaller price contractions, I think those two things will balance each other out quite nicely. Merdad?

Nicely.

Thank you some net murdo.

Yeah, and then and then on the <unk>, yes.

So the way we're thinking about it is that.

And Phil is that as you know the disclosed data from unit immunomedics on lung.

Have been promising.

Because.

Of the competitive.

Situation right now with with other molecules and lung our own interest and lung and the fact that we will see additional data from tropics three.

Merdad V. Parsey: Thank you. Yeah, and then on TRIDEL-V, yeah, so the way we're thinking about it is that, Bill, because of the competitive situation right now with other molecules in the lung, our own interest in the lung, and the fact that we'll see additional data from Tropic 3, we are planning at risk to do a Phase 3 study. Now, that will depend entirely on how the data is read out and the strength of the data.

And our planning at risk to do a phase III study now.

That will depend entirely on how the data readout and the strength of the data.

We may we may.

Need to or want to adapt from there, but we want to be aggressive and make sure that we don't.

And we don't lose any advantage that we may have so we're just being aggressive and based on our.

Conviction on the on the molecule and the.

And the MAA.

That's very helpful. Thank you.

Merdad V. Parsey: We may need to or want to adapt from there, but we want to be aggressive and make sure that we don't lose any advantage that we may have. So we're just being aggressive based on our conviction about the molecule and the MOA. That's very helpful. Thanks, Phil. And it just leaves me to just say a few things at the end. I mean, I speak on behalf of the entire leadership team, that we're clearly behind this next chapter of growth in Gilead, and it's here. And It's a variety of different things.

Thanks, Phil and it just leaves me to just say a few things at the and I mean, and I know I speak on behalf of the entire leadership team that.

We are clearly behind this next chapter of growth and Gilead and it's here and it's a variety of things of course, it's a clear path to growth and a sustainable and diverse portfolio. It's also the fact and we have a stable dividend.

And it is growing over time with the industry, leading dividend yield consistently strong cash flow robust balance sheet. So we're entering 2021 with confidence on this clear path to growth and I think you'll see us deliver on our new opportunities and oncology and sustain our leadership and HIV and we look forward to updating you every quarter on our progress throughout <unk>.

Daniel O'Day: Of course, there is a clear path to growth in the sustainable and diverse portfolio. But it's also the fact that we have a stable dividend that, you know, we're committed to growing over time with the industry-leading dividend yield, consistently strong cash flow, and robust balance sheet. So we're entering 2021 with confidence on this clear path to growth.

2021 so.

So thank you all for joining I'll, let Andrew have the last word here, but I also want to make sure. We thank all the colleagues at Gilead and our partners that made all this possible so andrew over to you.

Andrew D. Dickinson: And I think you'll see us deliver on our new opportunities in oncology and sustain our leadership in HIV. And we look forward to updating you every quarter on our progress throughout 2021. So thank you all for joining me. I'll let Andrew have the last word here. But I also want to make sure we thank all the colleagues at Gilead and our partners that made all this possible. So, Andrew, over to you. Well, thank you to them, and thank you all for joining us today.

Thank you to them and thank you all for joining US today. We appreciate your continued interest and Gilead and the team here looks forward to providing you with updates on our future progress. Thanks again.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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Okay.

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Andrew D. Dickinson: We appreciate your continued interest in Gilead, and the team here looks forward to providing you with updates on our future progress. Thanks again. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Yes.

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