Q4 2021 Gilead Sciences Inc Earnings Call

Good day, and thank you for standing by and welcome to the Gilead fourth quarter and full year 2021 earnings conference call at this.

Operator: Good day, and thank you for standing by. Welcome to the Gilead fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen-only mode.

All participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one 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 call.

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 one 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 speaker today, Jackie Ross, VP of Investor Relations. Please go ahead.

Over to your speaker today, Jackie Roth VP of Investor Relations. Please go ahead.

Thank you Gigi and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year 2021, the press release slides and supplemental data are available on the investors section of our website at Gilead Dot com.

Jackie Ross: Thank you, Gigi. And good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the fourth quarter and four years ending 2021. The press release slides and supplementary data are available on the investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Merdad Parsey, and our Chief Financial Officer, Andrew Dickinson.

The speakers on today's call will be our chairman and Chief Executive Officer, Daniel Day, Our Chief Commercial Officer, Joanna <unk>, Our Chief Medical Officer, Murdock, Parsi and our Chief Financial Officer, Andrew Dickinson.

Jackie Ross: After that, we'll open up the call to Q&A, where the team will be joined by Christy Schull, the Chief Executive Officer of KITE. Before we get started, let me remind you that we will be making forward-looking statements, including those 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, business, and operations, financial projections, and the use of capital, and 2022 financial guidance. All of these involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these expectations.

After that we'll open up the call to Q&A, where the team will be joined by Christi Shaw Chief Executive Officer Uptight.

Before we get started let me remind you that we will be making forward looking statements, including those related to the impact of the COVID-19 pandemic on Gilead business financial condition and results of operations plans and expectations with respect to products product candidates corporate strategy business and operations.

Jackie Ross: A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. 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.

Actual projections and the use of capital.

And 2022 financial guidance.

All of these involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

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

With that I'll turn the call over to Dan.

Thank you Jackie and good afternoon everybody.

Jackie Ross: The GAAP to Non-GAAP reconciliations are provided in the earnings press release available on the Gilead website. With that, I'll turn the call over to Dan. Thank you, Jackie, and good afternoon, everybody. As we head into 2022, Gilead is coming off a year of positive clinical momentum and strong financial performance, mitigating the impact of the pandemic on some parts of our business. Higher sales of iGlory more than offset the impact of COVID-19 on HIV and AIDS. The cleric continues to play a critical role in helping to treat people with COVID-19 through continued activity against the Omicron variant.

As we head into 2020 to Gilead is coming off a year of positive clinical momentum and strong financial performance mitigating the impact of the pandemic on some parts of our business.

Higher sales of it clearly more than offset the impact of COVID-19 on HIV and HCV.

The group continues to play a critical role in helping to treat people with COVID-19 with continued activity against the omicron variant.

Daniel O'Day: The FDA recently expanded its use beyond the hospital for patients at high risk of disease progression. In addition, we just initiated a phase one trial of GS5245, a novel oral COVID-19 nuclear side that once metabolized works in the same way as Remdesivir. Our full-year revenue for 2021 was 11% higher than the midpoint of our initial guidance in February of 2021. It was also an important year for transformation to become a business that is based on diverse, sustainable growth.

The FDA recently expanded its use beyond the hospital for patients at high risk of disease progression.

In addition, we just initiated a phase one trial of GFS by 245 <unk>.

A novel oral COVID-19 nuclear side.

It's metabolized works in the same way as <unk>.

Our full year revenue for 2021 was 11% higher than the midpoint of our initial guidance in February of 2021.

There was also an important year for our transformation to becoming a business that is based on diverse sustainable growth.

In 2021, we received seven approvals or accelerated approvals in the U S and Europe and submitted an additional six filings.

Daniel O'Day: In 2021, we received seven approvals or accelerator approvals in the US and Europe and submitted an additional six filings. Our approvals included three for TRDELV with the FDA and M.A. approval in second line triple negative breast cancer, as well as an accelerated approval from FDA for metastatic bladder cancer, two for cell therapy with Yaskarta receiving accelerated approval in relapsed or refractory follicular lymphoma and Ticardus receiving full approval in adult acute lymphoblastic leukemia, and two expanded labels in virology, one for a pediatric label for Bictarvy in the U.S. and an expanded label for Bicluri in the E.U. for adults not requiring supplemental oxygen.

Our approvals included three Pritchard Lv with the FDA and MAA approval in second line Triple negative breast cancer as well as an accelerated approval from FDA for metastatic bladder cancer.

Two for cell therapy with you Scott are receiving accelerated approval in relapsed or refractory follicular lymphoma and to Curtis receiving full approval and adult acute lymphoblastic leukemia.

Two expanded labels in virology, one for pediatric label for Big target in the U S and an expanded label for <unk> in the EU for adults not requiring supplemental oxygen.

Our 2022 plans include a significant increase in clinical development studies across our novel oncology portfolio.

Daniel O'Day: Our 2022 plans include a significant increase in clinical development studies across our novel oncology portfolio. We are planning at least 20 additional trials, including seven-day-three trials for Trudelby. And these include the ASCENT3 trial, which is evaluating Tordelvi and frontline AAA breast cancer in the PD-L1 negative population. The Ascent Fort Trial, in collaboration with Merck, to evaluate Tordelby and Contruder in the front line triple negative breast cancer population, the PD-I-1 positive population, and the EVOKE-III trial, which will be led by Merck, to evaluate Tordelvian contrada in non-small cell lung cancer.

We are planning at least 20 additional trials, including seven phase III for trials for <unk> and.

These include the <unk> III trial, which is evaluating <unk> in the frontline triple negative breast cancer in the PD lone negative population.

We are set for trial in collaboration with Merck to evaluate <unk> contributed in the frontline triple negative breast cancer.

Population in the PD lone positive population.

And the evoke three trial, which will be led by Merck to evaluate <unk> controller and non small cell lung cancer.

You will also see ongoing momentum in our virology portfolio as we continue to expand our leadership in anti viral therapies.

Daniel O'Day: You will also see ongoing momentum in our virology portfolio as we continue to expand our leadership in antiviral therapy. We are advancing our longer-acting HIV options with Lenacavivir as the foundation and look forward to potential regulatory decisions in 2022. If approved, lenacapavir would be the only HIV treatment option administered twice yearly.

We are advancing our longer acting HIV options with Atlantic half of the year as the foundation and look forward to potential regulatory decisions in 2022.

If approved <unk> would be the only HIV treatment option administered twice yearly.

Daniel O'Day: In addition, we'll continue to drive progress across our broader virology portfolio, including hepatitis, COVID-19, and other emerging viruses. This is a really important time in Gilead's transformation journey. After consistent work to execute on our strategy and expand our portfolio over the last two years, you will increasingly start to see this play out in tangible results. We're confident that Gilead has all the elements in place for a strong year and a strong decade.

In addition, we will continue to drive progress across our broader barology portfolio, including hepatitis COVID-19, and other emerging viruses.

This is a really important time and gilead transformation journey.

After the consistent work to execute on our strategy and expand our portfolio over the last two years, you will increasingly start to see this play out and tangible results.

We're confident that Gilead has all the elements in place for a strong year and a strong decade.

Joanna Mehrdad and Andy will now take you through the details of our progress in our plans.

Daniel O'Day: Johanna, Merdad, and Andy will now take you through the details of our progress in our plan. And let me first hand over to Johanna to talk about our commercial performance in the fourth quarter and the full year, and I'll be back to you in the Q&A.

Let me hand first over to Joanna to talk about our commercial performance in the fourth quarter and the full year and I'll be back to you in the Q&A Joanna.

Johanna Mercier: Thanks, Dan. Good afternoon, everyone. As you can see on slide 7, we had a strong end to the year with Q4 total product sales, excluding Bicklery, of $5.8 billion, up 7% quarter-over-quarter, driven by favorable pricing and inventory dynamics. This also represented 8% growth year-over-year, driven by continued recovery in the HIV treatment market and favorable pricing dynamics. Clery sales were higher than expected in Q4, reflecting the start of the Omicron surge, but lower than both the prior quarter and prior year, contributing to total product sales of $7.2 billion.

Dan Good afternoon, everyone.

As you can see on slide seven we had a strong end to the year with Q4 total product sales, excluding declaration of $5 8 billion up 7% quarter over quarter, driven by favorable pricing and inventory dynamics.

This also represented 8% growth year over year, driven by continued recovery in the HIV treatment market and favorable pricing dynamics.

<unk> sales were higher than expected in Q4.

Reflecting the start of the omicron surge, but lower than both the prior quarter and prior year and contributing to total product sales of $7 $2 billion for the quarter.

Moving to slide eight.

Johanna Mercier: Moving to slide 8, total fourth-quarter veterinary sales were $1.4 billion, bringing total sales for 2021 to $5.6 billion. Gilead is proud of the role that VicLurie continues to play in this pandemic. VicLurie has demonstrated activity against the Omicron variant and has helped many patients with COVID-19 in the most recent.

Fourth quarter Declaration sales were $1 4 billion, bringing total sales for 2021 to $5 6 billion.

Gilead is proud of the role that that core continues to play in this pandemic <unk> has demonstrated activity against the underground variant and has helped many patients with COVID-19, and the most recent search.

Johanna Mercier: Although symptoms have generally been less severe, the volume of overall cases has meaningfully increased since the emergence of Omicron, and we have seen the total number of hospitalizations increase as well. While we would all prefer to put this pandemic behind us, we expect the query to continue to play a critical role in 22 and beyond. As you'd expect, hospitalizations remain a key indicator for inpatient veterinary sales, and we're seeing higher hospitalizations in geographies with lower vaccination adoption, including certain parts of the U.S., as well as Eastern Europe.

Although symptoms have generally been less severe the volume of overall cases has meaningfully increased since the emergence of omicron and we've seen the total number of hospitalizations increased as well.

While we would all prefer to put this pandemic behind us we expect <unk> to continue to play a critical role in 'twenty two and beyond.

As you would expect hospitalizations remain a key indicator for inpatient enquiry sales and we're seeing higher hospitalizations in geographies with lower vaccination adoption, including certain parts of the U S as well as eastern Europe .

Johanna Mercier: Additionally, I'm very pleased to highlight that the FDA recently approved the SNDA filing for the use of Eclir in the outpatient setting for patients at high risk of disease. The approval was based on data generated in the Phase III pine tree study, further solidifying the credibility, importance, and role of vigorous, Now the inquiry will be able to help even more patients earlier and reduce the risk of hospitalization for COVID-19. Next, as shown on slide 9, total HIV sales were $4.5 billion in the corner.

Additionally, I'm very pleased to highlight that the FDA recently approved the SMB <unk> filing for the use of victory in the outpatient setting for patients at high risk of disease progression.

This approval was based on data generated in the phase III Pine tree study further solidifying the credibility importance and role of victory.

Now clearly we will be able to help even more patients earlier and reduce risk of hospitalization for COVID-19.

Next as shown on slide nine total HIV sales were $4 5 billion in the corner.

Johanna Mercier: Up 8% sequentially driven by favorable inventory and pricing dynamics, as well as changes to our gross Internet estimates in Q4 2021. For the full year, total HIV sales were $16.3 billion, down 4% year-over-year, primarily due to the Trivada and Atripla LOEs, in addition to pandemic-related impacts and pricing dynamics. The expected impact from the LOEs, which amounted to $1.3 billion, was offset by continued Victory growth.

Up 8% sequentially, driven by favorable inventory and pricing dynamics as well as changes to our gross to net estimates in Q4 of 2021.

For the full year total HIV sales were $16 3 billion down 4% year over year, primarily due to the truvada in a triplet hello.

In addition to pandemic related impacts and pricing dynamics.

The expected impact from the low <unk>, which amounted to $1 3 billion with offset by continued Victor Harvey Chris.

Excluding the sizable.

Johanna Mercier: Excluding the sizable LOE impact, HIV total product sales for the full year grew 4% compared to 2020, despite the ongoing pandemic headwind. We now expect the Travada and Trepla loss of exclusivity impact to be minimal going forward as the headwind dissipates starting in Q2 of this. In HIV treatment, we continue to see signs of market recovery, although the U.S. market declined 1% sequentially in On a year-over-year basis, overall marketing Q4 was up 1.5% in both the U.S. as well as EU5, despite screening and diagnosis rates still below pre-pandemic levels.

Low impact HIV total product sales for the full year grew 4% compared to 2020, despite the ongoing pandemic headwinds.

We now expect the Truvada and <unk> loss of exclusivity impact to be minimal going forward as the headwind dissipate starting in Q2 of this year.

In HIV treatment, we continue to see signs of market recovery, although the U S market declined 1% sequentially in Q4, following two quarters of sequential growth.

On a year over year basis. The overall market in Q4 was up one 5% in both the U S as well as EU five despite screening and diagnosis rates still below pre pandemic levels.

As you know favorable dynamics play out in the fourth quarter of every year and HIV in 2021 with no different with some yearend inventory stocking and favorable seasonal pricing as well as changes in our gross to net estimate in Q4 2021.

Johanna Mercier: As you know, favorable dynamics play out in the fourth quarter of every year in HIV, and 2021 will be no different, with some year in inventory stocking and favorable seasonal pricing, as well as changes in our growth to net estimates in Q4 2021. As you think about 2022, I'll remind you of the normal HIV inventory build-up in 2.4 and the new year reset for patient co-pays and donut hole payments. Given these factors, along with the favorable pricing dynamics I just mentioned, we expect the sequential declining Q122 to be greater than Q121. Nonetheless, we expect a strong year overall in HIV and expect continued growth in subsequent quarters.

As you think about 2022.

Remind you of the normal HIV inventory buildup in Q4, and the new year reset for patient co pays and donut hole payments.

These factors along with the favorable pricing dynamics I just mentioned, we expect a sequential decline in Q1, 'twenty two to be greater than Q1, 'twenty one nonetheless.

We expect a strong year overall in HIV and expect continued growth in subsequent quarters.

Back to Q4, <unk> had another record quarter with sales of $2 5 billion up 11% sequentially and 22% year over year.

Johanna Mercier: Back to Q4, Viktarvi had another record quarter with sales of $2.5 billion, up 11% sequentially and 22% year-over-year. On slide 10, you can see that Victor V. US treatment market share increased over five share points in 2021, reaching 42%, which is the highest share that any complete regiment has ever achieved in this. For the full year, BicTARBi sales were $8.6 billion, growing 19% from 2020, and BicTARBi remains the leading prescribed treatment for naive and switched patients in the U.S., as well as number one in n SCOBY revenue for the fourth quarter was $473 million, up 9% quarter-over-quarter, primarily as a result of favorable seasonal pricing and inventory dynamics, as well as continued demand.

On slide 10, you can see that the target U S treatment market share has increased over five share points in 2021, reaching 42%, which is the highest here that any complete regimen has ever achieved in this market.

For the full year <unk> sales were $8 6 billion growing 19% from 2020, and <unk> remains the leading prescribed treatment for naive and switch patients in the U S as well as number one in naive in EU.

<unk> revenue for the fourth quarter with $473 million up 9% quarter over quarter, primarily as a result of favorable seasonal pricing and inventory dynamics as well as continued demand.

We expect <unk> revenue to continue to be driven by prep as the scope has maintained about 45% of overall market prescriptions in the U S.

Johanna Mercier: We expect DSCOVI revenue to continue to be driven by PrEP, as DSCOVI has maintained about 45% of overall PrEP market prescriptions in the U.S., will continue to ensure access to support physician choice, and expect growing demand and market expansion to offset the impact of increased commercial contracts. Overall, while near-term growth continues to be impacted by local pandemic-related social restrictions, we're encouraged by the growing PrEP market. In Q4, the overall PrEP market grew 4% quarter-over-quarter and 31% year-over-year.

We will continue to ensure access to support physician choice and expect growing demand and market expansion to offset the impact of increased commercial contracting.

Overall, while near term growth continues to be impacted by local pandemic related social restrictions. We're encouraged by the growing market in Q4, the overall market grew 4% quarter over quarter and 31% year over year looking forward, we believe Atlantic half of the year, our investigational longer acting prep offering could potentially catalyze this.

Johanna Mercier: Looking forward, we believe Lenacapavir, our investigational, longer-acting PrEP offering, could potentially catalyze this market well beyond the 25% penetration rate in PrEP that we see today. Living to slide 11, it's clear that HCV continues to be part of our portfolio most impacted by the pandemic Although there was some slight quarter of a quarter recovery market starts in the EU 5, US market starts declined resulting in flat total starts over, While Gilead market share increased modestly on a sequential basis in both the U.S. and the EU, this was more than offset by unfavorable pricing dynamics, resulting in Q4 total sales of $393 million, down 8% sequentially, and 7% year-over-year.

Market well beyond the 25% penetration rate in prep that we see today.

Moving to slide 11, it's clear that HCV continues to be part of our portfolio most impacted by the pandemic. Although there was some slight quarter over quarter recovery market starts in the EU five U S market starts declined resulting in flat total starts overall.

While gilead market share increased modestly on a sequential basis in both the U S and the EU this was more than offset by unfavorable pricing dynamics.

<unk> in Q4, total sales of $393 million down, 8% sequentially and 7% year over year.

Johanna Mercier: As you can see on slide 12, our HBV and HDV franchise reported record quarterly revenues of $265 million, up 7% sequentially due to seasonal inventory and favorable pricing. The 9% year-over-year growth was primarily driven by Van Liddy demand.

As you can see on slide 12.

HBV in HDD franchise reported record quarterly revenues of $265 million up 7% sequentially due to seasonal inventory and favorable pricing.

A 9% year over year growth was primarily driven by them Lady demand.

Johanna Mercier: Total fiscal year sales for this franchise were $969 million, up 13% year-over-year. HEP GLUDEX reported $12 million of sales in Q4 in Europe, with $37 million in 2021 sales since our acquisition in late the first quarter. HEP Cludex is currently available in Germany and France in addition to a number of early access programs in countries such as Austria, Italy, and Greece.

Fiscal year sales for this franchise for $969 million up 13% year over year.

<unk> reported $12 million of sales in Q4 in Europe with $37 million in 'twenty, one sales since our acquisition in late first quarter.

<unk> is currently available in Germany in France. In addition to a number of early access program in countries, such as Austria, Italy and Greece.

In 2022, and it's part of our comprehensive commercialization plan, we expect to finalize reimbursement for lunch and a number of major European markets.

Johanna Mercier: In 2022, and as part of our comprehensive commercialization plan, we expect to finalize reimbursement for launch in a number of major European markets. In the U.S., we filed a BLA in November, and FDA granted priority review for accelerated approval with a PDUFA date set for the third quarter, as well as an advisory committee meeting that will be scheduled in the coming month. Moving to oncology, first with fidelity on slide 13, global sales were 118 million in the fourth quarter, up 17% sequentially, and up 84% year-over-year compared to full Q4 2020. Disreflect, Growing Adoption of the Second Line Metastatic TNVC Indication, which was noted as a preferred regimen and the NCCN Breast Guidelines updated in.

In the U S. We filed the BLA in November and FDA granted priority review for accelerated approval with the <unk> date set for the third quarter as well as an advisory committee meeting that will be scheduled in the coming months.

Moving to oncology first with <unk> on Slide 13, global sales were $118 million in the fourth quarter up 17% sequentially and up 84% year over year compared to full Q4 2020.

This reflects growing adoption of second line metastatic CNBC indication, which was noted as a preferred regimen in the mtc and breast guidelines are updated in September .

Johanna Mercier: We're also starting to see stronger unaided brand awareness, which is resulting in continued market share growth. In second line TNBC, Tredelby now captures approximately one in four new news starts in the U.S. We've expanded our oncology footprint globally, including tripling our U.S. headcount to further accelerate penetration of Tredelby and prepare for a potential HR-positive and HER2-negative. Additionally, EU approval for Tredelby was granted in late November 2021, and we've already seen strong momentum in France and Germany since their launch.

We're also starting to see stronger unaided brand awareness, which is resulting in continued market share growth.

In second line <unk> now captures approximately one in four new starts in the U S wed.

We've expanded our oncology footprint globally, including tripling, our U S head count to further accelerate penetration of Qdoba and prepare for a potential HR positive in her two negative launches.

Additionally, EU approval for <unk> to Adobe was granted in late November 2021, and we've already seen strong momentum in France, and Germany since their launch.

Johanna Mercier: We plan to launch a number of new countries following key reimbursement decisions. Now, on slide 14 on behalf of Christie and the kite team, South therapy, Q4 sales of 239 million reflected 47 percent Eurorear growth, and 8 percent increased quantity. For the quarter, Yaskarta's sales of $182 million were up 41% year over year, driven by continued demand and relapse over factory-large B-cell lymphoma and follicular lymphoma.

We plan to launch a number of new countries following key reimbursement decisions this year.

Now on slide 14 on behalf of Christie and the kite team cell therapy, Q4 sales of $239 million reflected 47% year over year growth and 8% increase sequentially.

For the quarter yesterday's sales.

Of $182 million were up 41% year over year, driven by continued demand in relapsed or refractory large b cell lymphoma, and Follicular lymphoma, Jakarta sales of $57 million in the quarter reflected 68% year over year growth based on growing global demand for relapsed or refractory mantle cell lymphoma and early contribution.

Johanna Mercier: Carter's sales of $57 million in the quarter reflected 68% year-over-year growth based on growing global demand for relapsed or refractory mantle cell lymphoma and early contribution for adult acute lymphoblastic leukemia in the U.S. As a reminder, FDA granted a marketing authorization for Carter in adult ALL in October. In just the first few months of launch, there has already been strong demand that we expect to continue in the coming quarters given the high unmet needs.

Adult acute lymphoblastic leukemia in the U S.

As a reminder, FDA granted to Curtis approval in adult ALLL in October .

And just the first few months of launch there has already been strong demand that we expect to continue in the coming quarters, given the high unmet need.

Full year cell therapy sales of $871 million reflected 43% year over year growth driven by continued L. Bcl mcl demand globally as well as the new launches.

Johanna Mercier: Full-year stealth therapy sales of 871 million reflected 43% year-over-year growth driven by continued LBCL and MCL Demand globally as well as New London. The strong growth we've seen with these recent launches reinforces our belief that cell therapy adoption will continue its positive momentum as more physicians understand the benefits for appropriate patients and therefore increase referral rates to treatment. Merdad will elaborate later, so I'll just quickly mention the impressive data KITE presented at ASH in December: 43% overall survival rate after 5 years in 3rd line LBCL patients.

The strong growth we've seen with these recent launches reinforces our belief that cell therapy adoption will continue its positive momentum as more physicians understand the benefits for appropriate patients and therefore increase referral rates to treatment centers.

Doug will elaborate later, so I'll just quickly mention the impressive data presented at Ash in December 43% overall survival rate after five years in third line <unk> patients.

The <unk> data at Ash, not only highlighted the long term real world safety and efficacy profile in third line or Bcl, but also in earlier lines of therapy.

Johanna Mercier: The Yaskarta data at ASH not only highlighted the long-term real-world safety and efficacy profile of Yaskarta in third-line LBCL but also in earlier lines of therapy. For Zuma 7 data in second-line LBCL, FDA has set a PDUSA date of April 1st, when we hope Yaskarta will be granted approval. In the meantime, the kite team is ramping up manufacturing capacity to meet anticipated demand.

Presuming seven data in second line <unk> FDA has set a <unk> date of April one when we hope you start it will be granted approval.

In the meantime, the kite team is ramping up manufacturing capacity to meet the anticipated demand.

Johanna Mercier: Ted expects the New Maryland Facility to begin commercial operations within two days. Combined with the Amsterdam and El Secundo facilities, we expect increased operational capacity by up to 50% by the end of this year. Christy is here with the team and available to take questions on cell therapy during our Q&A. In closing, our oncology sales were $1.25 billion in 2021, and we expect robust growth in the coming years. And so with that, I'll hand it over to Merdad.

Expect the new Maryland facility to begin commercial operations by Q2.

Combined with the Amsterdam, and Elsa can do facilities, we expect increased operational capacity by up to 50% by the end of this year.

Christy's here with the team and available to take questions on cell therapy during our Q&A and.

In closing our oncology sales were $1 25 billion in 2021, and we expect it.

Robust growth in the coming years, and so with that I'll hand, it over to Mary to add for pipeline update thanks, Sean and good afternoon, everyone.

Merdad Parsey: Thanks, John, and good afternoon, everyone. Building on what both Johanna and Dan have said, the Gilead team rounded out a very strong 2021 with further progress across our portfolio. In 2021 alone, we began enrolling patients in 13 oncology, 13 virology, and 4 inflammation treatments, and we have recently shared the initial details of the ambitious development programs we're targeting for 2020. As we look forward, we're confident that we have the foundation to continue to build a robust, diverse portfolio across our three focused therapeutic areas.

Building on both Joanna and Dan have said the Gilead team running on a very strong 2021 further progress across our portfolio.

In 2021 alone we began enrolling patients in 13 oncology 13, barology and for inflammation trials.

We recently shared the initial details of the ambitious development programs, we are targeting for 2022.

As we look forward, we are confident that we have the foundation to continue to build a robust diverse portfolio across our three focus therapeutic areas.

Merdad Parsey: First, on slide 16, Viclory continues to play a vital role in the fight against COVID-19. It was the first approved treatment for patients hospitalized with COVID-19, and we recently expanded indication labels in the U.S. and the EU. In December, the European Commission approved a variation to the Conditional Marketing Authorization for Viclory for the treatment of COVID-19 in adults not on supplemental oxygen.

First on slide 16, the glory continues to play a vital role in the fight against COVID-19 liquidity was the first approved treatment for patients hospitalized with COVID-19, and we recently expanded indication labels in the U S and the EU in December the European Commission approved variation to the conditional marketing authorization for <unk>.

For the treatment of COVID-19, and adults not on supplemental oxygen.

Merdad Parsey: And last month, based on the data from the Phase 3 Pine Tree Study, the FDA expanded the approval of ICLORI to include non-hospitalized patients at high risk for COVID-19 disease progression. These expanded indications speak to the activity of victory against the coronavirus variants we've seen so far, including them. We believe there will continue to be a need for victory delivered intravenously, especially for higher-risk patients. The potential for continued COVID-19 variants and infections highlights the need for more convenient oral formulations to expand the options for outpatients.

And last month based on the data from the Phase III <unk> study the FDA expanded the approval of inquiry to include non hospitalized patients at high risk for COVID-19 disease progression.

These expanded indications speak to the activity of <unk> against the coronavirus variance, we've seen so far including <unk>.

We believe we will continue to be a need for burglary delivered intravenously, especially for higher risk patients the.

The potential for continued COVID-19 variance and infections highlight the need for more convenient oral formulations to expand the options for our patients.

As such we've just initiated a phase one trial of <unk> 245, a novel oral COVID-19, nucleoside that once metabolized works in the same way as our investment here.

Merdad Parsey: As such, we've just initiated a phase one trial of GS-5245, a novel oral COVID-19 nucleoside that, once metabolized, works in the same way as remdesivir. Pending data, the evolving pandemic landscape, and discussions with regulatory agencies, we're hoping to initiate a registrational trial before the end of the year. Moving to HIV on slide 17, we shared an overview of some of our long-term development activities a few weeks ago to highlight the diversity of our portfolio and how it targets the entire HIV life cycle.

Pending data the evolving pandemic landscape and discussions with regulatory agencies, we're hoping to initiate a registrational trial before the end of the year.

Moving to HIV on Slide 17, we shared an overview of some of our long acting development activities in a few weeks ago to highlight the diversity of our portfolio and how it targets the entire HIV lifecycle.

Merdad Parsey: We continue to believe that our investigational agent, Lenna Caviveer, is a unique and foundational asset given its potential for extended dosing in addition to the compelling efficacy and safety profile highlighted in Capella and Calibrate. Next, on slide 18, you can see our current clinical efforts with long-acting HIV therapy. As previously announced, the phase two study evaluating the oral combination of lanocafavir with Merck's islatravir is on partial clinical hold, and Merck remains in discussions with the FDA on next steps for islatravir.

We continue to believe that our investigational agent, let me kind of a unique and foundational asset given its potential for extended dosing. In addition to the compelling efficacy and safety profile highlighted in the Capella and calibrate studies.

Next on Slide 18, you can see our current clinical efforts with long acting HIV therapeutics as previously announced the phase II study evaluating the oral combination of lending comp review with Merck's <unk> is on partial clinical hold.

Merck remains in discussions with the FDA on next steps for <unk>.

In the meantime, we at Gilead continue to develop a number of other potential partner agents for Linda <unk> in HIV treatment and look forward to sharing some more detail on these programs and our urology deep dive later this month.

Merdad Parsey: In the meantime, we at Gilead continue to develop a number of other potential partner agents for lenticapavir and HIV treatment and look forward to sharing some more detail on these programs at our virology deep dive later this month. We remain confident and excited about Lana Caballero's future potential to deliver options for people living with HIV or those who could benefit from PrEP. I want to be very clear that the recent clinical hold for the Lenacapavir trials, which the FDA initiated in December, is not associated with the Lenacapavir molecule itself. Rather, the hold reflects concern about the compatibility of certain vials with Lennon Capavir's solution.

We remain confident and excited about <unk> future potential to deliver options for people living with HIV, where those who could benefit from prep.

I wanted to be very clear that the recent clinical hold for Atlantic capital of your trials, which the FDA initiated in December is not associated with Atlanta copy of your molecule itself.

Rather the hold reflects concerned about the compatibility and certain vials with Atlantic <unk> solution.

Merdad Parsey: We continue to work with the FDA to remediate the concern and to agree on a path to resume these trials. We're hopeful this can be achieved quickly. As such, we continue to expect an FDA decision for Lenacapavir and heavily treatment-experienced individuals in the first half of 2020. If successful, Lenacavivir will become the first available six-month long-acting subcutaneous injection for the treatment of HIV.

We continue to work with the FDA to remediate the concern and to agree on a path to resume these trials for.

Were hopeful this can be achieved quickly as such we continue to expect an FDA decision for <unk> in heavily treatment experienced individuals in the first half of 2022.

If successful lending category will become the first available six months long acting subcutaneous injection for the treatment of HIV.

Next moving to <unk> on slide 18, I am pleased to confirm that we now expect to share both top line progression free survival data as well as the first planned interim analysis of our overall survival from tropics <unk> in March.

Merdad Parsey: Next, moving to fidelity on slide 18, I'm pleased to confirm that we now expect to share both top-line progression-free survival data as well as the first planned interim analysis of our overall survival from Tropics O2 in March. There has been a convergence of events for PSS and OS such that we'll be able to conduct and report the single analysis of these outcomes rather than have two analyses separated by a short interval. Gilead remains blinded to the data, and we're excited to be able to share this more complete view later this year. We are targeting an SBLA filing in the second half of 2022, depending, of course, on the readout. If the data are positive, we believe that Trudeldy could represent a very important treatment option for HR positive for two negative patients who are home-run refractory and have very limited options.

Theres been a convergence of events for PFS and OS such that we will be able to conduct and report a single analysis of these outcomes rather than have to analysis separated by a short interval.

Gilead remains blinded to the data and we're excited to be able to share. This more complete view later this quarter.

Targeting <unk> filing in the second half of 2022, depending of course on the readout.

If the data are positive we believe that <unk> could represent a very important treatment option for HR positive <unk> negative patients who are home loan refractory and have very limited options.

Reflecting our confidence in <unk> overall, we're expanding the number of clinical programs in 2022 to evaluate effectiveness in breast lung and bladder cancers with plans to initiate study startup activities for at least seven phase III trials.

Merdad Parsey: Reflecting our confidence in TRODELV overall, we're expanding the number of clinical programs in 2022 to evaluate effectiveness in breast, lung, and bladder cancers with plans to initiate study startup activities for at least seven phase three trials. Three of these are expected to enroll their first patients in 2022, including two in front-line metastatic TNBC and another in a front-line non-small cell lung cancers study that will be led. Going forward, we will separately disclose trial startup activities versus FPI milestones. Additionally, in the first half of this year, we plan to add a combination of Tridelby with other Gilead portfolio assets as a study or an additional cohort in an existing study.

Three of these are expected to enroll the first patients in 2022, including two in frontline metastatic <unk> and another in frontline non small cell lung cancers studied.

That will be led by Merck.

Going forward, we will separately disclose trial startup activities versus Spi milestones.

Additionally, in the first half of this year, we plan to add a combination of <unk> with other gilead portfolio assets as a study or an additional cohort in an existing study.

Merdad Parsey: We look forward to sharing more details at our upcoming Oncology Deep Dive in April. This is another example of the versatility and tremendous potential that Trudeau-Ville, Trudeau-Ville, along with the growing oncology portfolio can generate. Next, slide onto McGrolamat.

We look forward to sharing more details in our upcoming oncology deep dive in April .

This is another example of the versatility and tremendous potential that <unk> <unk>, along with the growing oncology portfolio can generate.

Next slide onto my guerrilla map early last week, the FDA placed a partial clinical hold pausing enrollment and screening and trials in cohorts in the U S. Evaluating <unk> in combination with Decitabine. Following a review of our preliminary dataset, suggesting an apparent imbalance and investigator reported <unk> or unexpected.

Merdad Parsey: Early last week, the FDA placed a partial clinical hold pausing enrollment and screening and trials and cohorts in the U.S. The Value and McGrolamat, in combination with a decided team following a review of a preliminary data set, suggesting an apparent imbalance in investigator reported SARS, or unexpected serious adverse reactions, between treatment groups and our ongoing phase three trial in high-risk MDF. A subsequent partial clinical hold has been placed on the Phase 2 Multiple Myeloma Study and the Fully Enrolled Phase 2 DLV-CL Study.

Sorry suspected unexpected serious adverse reactions.

Between treatment groups and our ongoing phase III trial in high risk Mds.

The subsequent partial clinical hold has been placed on the phase II multiple myeloma study in a fully enrolled phase III <unk> study.

Merdad Parsey: Importantly, patients currently enrolled in our MacrolaMap studies can continue treatment, and our compassionate youth programs remain open. We're working with the FDA to take a comprehensive look at the safety data, and we'll share the outcome as quickly as we can. In the meantime, we remain committed to the MacrolaMap development program and believe that it has the potential to address an important unmet medical need in these seriously opaque patients. As you know, the patients in our Enhanced Space 3 trial had a very high-end met need, with a median overall survival of only one to three years on the current standard of care. Separate from and prior to the partial clinical hold, our phase 1B single-arm study in higher risk MDS no longer has a viral path to submission based on regulatory feeds.

Importantly patients currently enrolled in arm enrolling that study can continue treatment and our compassionate use programs remain open.

We're working with the FDA to take a comprehensive look at the safety data and we will share the outcome as quickly as we can.

In the meantime, we remain committed to the Monroe amount development program and believe that it has the potential to address an important unmet medical need in these seriously ill patients.

As you know the patients in our enhanced phase III trial have a very high unmet need with a median overall survival of only one to three years on the current standard of care.

Separate from <unk> and prior to the partial clinical hold our phase <unk> single arm study in higher risk Mds no longer has a viable path to submission based on regulatory feedback.

Merdad Parsey: As such, we'll remain focused on our Phase III Enhanced Study and look forward to sharing the 1B data at an upcoming scientific meeting. Next, moving to cell therapy on slide 21, on behalf of Christy and the CHITE team, I'll share a brief update on the impressive data CHITE presented at ASH last December. First, as you may recall, in 2020, we shared that Yees Garda had a four-year overall survival rate of 44% and third in LBCL patients.

As such we remain focused on our phase III enhance study and look forward to sharing the <unk> data in an upcoming scientific meeting.

Next moving to cell therapy on slide 21 on behalf of Christiana Mackay team I'll share a brief update on the impressive data presented at Ash last December .

First as you may recall in 2020, we shared that <unk> had a four year overall survival rate of 44% and 39 <unk> patients.

Merdad Parsey: At ASH in December, we presented five-year data from Zuma 1 and third-line LVCL patients showing Yaskarta demonstrated a remarkable and durable 43% overall survival rate, stable since our four-year up. Additionally, 92% of the patients who remained alive at five years have not needed any additional cancer treatment since their one-time infusion of Ascardo. It's truly inspiring to see this type of durability for CAR T cells there. As announced yesterday, the FDA approved a label update for Yaskarta to include the use of prophylactic corticosteroids across all approved indications. Adding prophylactic courage use can improve the management of certain side effects without compromising the activity of Yaskart.

At Ash in December we presented five year data from Zuma, one in third line <unk> patients showing us garner demonstrated remarkable and durable 43% overall survival rates stable since our four year update.

Additionally, 92% of the patients who remained alive at five years have not needed any additional cancer treatments since they're onetime infusion of <unk> cargo.

It's truly inspiring to see this type of durability for car T cell therapies.

As announced yesterday, the FDA approved a label update for <unk> to include use of prophylactic corticosteroids across all approved indications adding.

Having prophylactic steroid use can improve the management of certain side effects without compromising the activity of U S cargo.

Merdad Parsey: For example, the FDA label now shows no grade three or greater cytokine release syndrome events occurred using the cohort six protocol as compared to 13% in the original label. This label update complements data published in 2021 showing 68% of patients had no CRS or neurological events within 72 hours of the ASCARD infusion. As we looked at earlier lines of treatment, the landmark ZUMA 7 trial evaluating Yaskarta and second-line relapsed refractory LBCL demonstrated a greater than fourfold increase in median event-free survival, or EFS, compared to standard of care through two years of follow-up. As you can see on the slide, the EFS curve for Yaskarta is compelling.

For example, the FDA label now shows no grade three or greater cytokine release syndrome events occurred using the cohort six protocol as compared to 13% in the original label.

This label update compliments data published in 2021, showing 68% of patients had no crs or neurological events within 72 hours of use garden infusion.

As we look to earlier lines of treatment. The landmark Zuma seven trial evaluating <unk> in second line relapsed refractory <unk> demonstrated a greater than four fold increase in median event free survival or PFS compared to standard of care through two years of follow up.

As you can see on the slide DFS current bring us garner as compelling ESPN was filed last quarter and we expect an FDA decision by April of this year.

Merdad Parsey: The SBLA was filed last quarter, and we expect an FDA decision by April of this year. In terms of the first-line LBCL data, Yaskarta demonstrated 89% overall response rate in high-risk patients and 78% complete response with a medium follow-up of 15.9 months. Given these encouraging data, the CITE team is in discussions with regulatory authorities on a potential path forward for frontline LBCL. And finally, on slide 22, we highlight the key 2022 catalysts across the portfolio, many of which I've just mentioned.

In terms of the first line <unk> demonstrated 89% overall response rate and high risk patients and 78% complete response with a median follow up of $15 nine months.

Given these encouraging data the kite team is in discussions with regulatory authorities on a potential path forward in frontline <unk>.

And finally on slide 22, we highlight the key 2022 catalysts across the portfolio many of which I've just mentioned.

Merdad Parsey: I'd also like to take a moment to highlight the three ARCIS milestones in the second half of this year. Last quarter, Gilead opted in to the three ARCIS programs, which added four assets to our portfolio.

I'd also like to take a moment to highlight the three ARCUS milestones in the second half of this year.

Last quarter Gilead opted into the three ARCUS programs, which added four assets to our portfolio John Vanilla Mab FC silent anti <unk> antibody <unk> hundred eight and FC active anti <unk> antibody.

Merdad Parsey: AB308, an FC active anti-tigid antibody. Atruma Dentant, an Adenosine Receptor antagonist, and Quimlett-Glistat, a small molecule CD73 inhibitor. Together with ARCIS, we expect to share ARC-VII Phase II PFS data in the second half of 2022, which will include data for Zimbarellamab monotherapy, Zim and Dom doublet, as well as Zim, Dom, and Atruma triplet. We look forward to sharing data when available and are very excited to collaborate more closely with ARCIS to accelerate future development.

<unk> and adenosine receptor antagonist.

And with that a small molecule <unk> 73 inhibitor.

Together with ARCUS, we expect to share our <unk> phase III PFS data in the second half of 2022, which will include data for the Zimbra Allomap monotherapy.

Jim and Don Doublet, as well as the Zim, Dom and <unk> triplet arm.

We look forward to sharing data when available and are very excited to collaborate more closely with ARCUS to accelerate future development plans.

On Slide 23, you can see the Gilead portfolio now encompasses 55 clinical stage programs nearly doubling since 2019.

Merdad Parsey: On slide 23, you can see that Gilead's portfolio now encompasses 55 clinical-stage programs, nearly doubling since 2019. Given the exciting potential of our portfolio across virology, oncology, and early-stage inflammation assets, this is just the beginning. Our teams are committed to advancing the most promising programs that will help transform patient outcomes, and we look forward to sharing our progress with you over the coming quarters and years.

Given the exciting potential of our portfolio across Barology oncology and early stage inflammation assets. This is just the beginning our teams are committed to advancing the most promising programs that will help transform patient outcomes and we look forward to sharing our progress with you over the coming quarters and years.

That I'll hand, it over to Andy.

Thank you Mary Anne and good afternoon, everyone.

Andrew Dickinson: Thank you, Merdad, and good afternoon, everyone. It was a strong close to 2021, driven primarily by strong HIV and vaccine revenue in the fourth quarter. For the full year, and excluding the impact of Eloise, HIV grew 4% year-over-year, driven by the continued strong performance of Bittarvi, which achieved a record US market share of 42% and sales of $8.6 billion, up 19% from 2020. Oncology was another highlight from both a pipeline and a revenue perspective, with full-year cell therapy sales of $871 million, growing 43% from 2020, and Tredelvi sales of $380 million in its first full year.

It was a strong close to 2021, driven primarily by strong HIV and Vic Lorie revenue in the fourth quarter.

For the full year and excluding the impact of the low <unk>.

<unk> grew 4% year over year, driven by the continued outperformance of <unk>, which achieved record U S market share of 42%.

Sales of $8 $6 billion up 19% from 2020.

<unk> was another highlight from both the pipeline on a revenue perspective with full year cell therapy sales of $871 million growing 43% from 2020 entered Lv sales of $380 million in its first full year by.

2030, we anticipate our oncology franchise will represent at least a third of our total revenue.

Andrew Dickinson: By 2030, we anticipate our oncology franchise will represent at least a third of our total revenue. Before I get into the normal P&L review and 2022 guidance, I want to address the EPS results for this quarter up front. Slide 25 highlights two sizable expenses that occurred after we gave our last guidance update in October. First, and subsequent to the exercise of Gilead's opt-in to four arcassassets in December, our fourth quarter results reflect a net charge of $125 million recorded in R&D. This charge reflects our $725 million option payment recognizing Q4 less $100 million that was previously accrued.

Before I get into the normal P&L review in 2020 to guidance I wanted to address the EPS results for this quarter upfront.

Andrew Dickinson: This impacted our EPS by about $0.38 in Q4 and for the full year. [Inaudible] Second, and as part of a legal settlement with Veeve and related parties, we have agreed to make a one-time $1.25 billion payment, in addition to an ongoing 3% royalty for future sales at McFarvey and the Pythagorevere component of any Pythagorevere-containing products in the [inaudible] This royalty extends until October 5 of 2027. The $1.25 billion payment was recorded in our fourth quarter results and reflected in our cost of goods sold.

Slide 25 highlights two sizable expenses that occurred after we gave our last guidance update in October .

And subsequent to the exercise of Gilead the opt in to four ARCUS assets in December our fourth quarter results reflect a net charge of $625 million recorded in R&D. This charge reflects our $725 million option payment recognized in Q4 less $100 million that was previously accrued.

This impacted our EPS by about 38 in Q4 and for the full year.

Second and as part of a legal settlement with Veeva and related parties. We have agreed to make a onetime $1 $25 billion payments. In addition to an ongoing 3% royalty for future sales of RV and the dictator of your component of any <unk> containing products in the United States.

This royalty extends until October five of 2027.

The $1 $25 billion payment is recorded in our fourth quarter results and reflected in our cost of goods sold.

Andrew Dickinson: This charge constituted an approximately 17% impact on gross margin in the fourth quarter, and it impacted our EPS by 80 cents for Q4 2021 and the full year. Going forward, we expect the impact of this new royalty to be approximately 1% on our gross margin starting in the first quarter of 2022. Excluding these items and their combined $1.18 of impact, our full-year non-gap EPS would have exceeded the guidance range that we set back in October, helped by stronger than expected vequery's performance.

This charge constituted an approximately 17% impact the gross margin in the fourth quarter and it impacted our EPS by <unk> <unk> for Q4, 2021, and the full year.

Going forward, we expect the impact of this new royalty to be approximately 1% on a gross margin starting in the first quarter of 2022.

Excluding these items and their combined $1 18 and impact our full year non-GAAP EPS would have exceeded the guidance range that we set back in October helped by stronger than expected <unk> sales.

Moving back to our quarterly review on Slide 26 fourth quarter revenue in our base business included HIV product sales growth of 7% year over year and 8% sequentially.

Andrew Dickinson: Moving back to our quarterly review on slide 26, fourth quarter revenue in our base business included HIV product sales growth of 7% year over year and 8% sequentially. Baclori sales were higher than expected due to the start of the Omicron surge.

<unk> sales were higher than expected due to the start of the omicron Serge non-GAAP product gross margin was 75% impacted by the legal settlement that I referenced earlier and non-GAAP R&D was impacted by the ARCUS, often resulting in non-GAAP EPS of <unk> 69 per share.

Andrew Dickinson: Non GAP product gross margin was 70.5%, impacted by the legal settlement that I referenced earlier, and non GAP R&D was impacted by the ARCIS opt-in, resulting in non GAP EPS of 59 cents per share. Our non-GAAP effective tax rate for the fourth quarter was 32.2%, reflecting tax expense related to uncertain tax positions and an increase in valuation allowance, as well as the impact of discrete tax benefits related to legal settlements with tax authorities in 2020 that did not recur this year.

Our non-GAAP effective tax rate for the fourth quarter was 32, 2%, reflecting tax expense related to uncertain tax positions and an increase in valuation allowance as well as the impact of discrete tax benefits related to legal settlements with tax authorities in 2020 that did not recur this year.

Andrew Dickinson: For the full year, on slide 27, total product sales of $27 billion grew 11% driven by Vic Lurie. Excluding Vecluri, total product sales were roughly flat at $21.4 billion as growth in VicTarvi and Oncology offset the $1.3 billion impact of Truvada and A-triplet LOEs in the United States. I touched on the main P&L impacts in the fourth quarter discussion, but I'll highlight that our non-GAAP effective tax rate for 2021 was 20.4% despite the higher effective tax rate in the fourth quarter. Moving now to slide 28.

For the full year on slide 27, total product sales of $27 billion grew 11% driven by <unk> <unk>.

Excluding that glory total product sales were roughly flat at $21 4 billion as growth in Big Party in oncology offset the $1 3 billion impacted the truvada and <unk> in the United States.

I touched on the main P&L impacts in the fourth quarter discussion, but I'll highlight that our non-GAAP effective tax rate for 2021 was 24% despite the higher effective tax rate in the fourth quarter.

Moving now to slide 28.

Andrew Dickinson: Our 2022 guidance assumes that the recent Omicron surge represents the only major COVID-19 wave for 2022 and that our HIV business will continue to recover from the pandemic. With that in mind, we expect product sales in the range of $23.8 to $24.3 billion. Excluding that glory, we expect product sales in the range of $21.8 to $22.3 billion, representing growth of 2 to 4% for our base business year over year. Relative to Q1, I'll remind you to expect HIV revenue to decline sequentially.

Our 2022 guidance assumes that the recent omicron surge represents the only major COVID-19 wave for 2022, and then our HIV business will continue to recover from the pandemic.

With that in mind, we expect product sales in the range of 23, 8% to $24 3 billion.

Excluding bank Levy, we expect product sales in the range of 21, 8% to $22 3 billion.

Representing growth of 2% to 4% for our base business year over year.

Relative to Q1, I'll remind you to expect HIV revenue to decline sequentially.

Andrew Dickinson: This is a normal dynamic for HIV due to inventory and seasonal pricing impacts. And you'll recall that last year, HIV revenue declined 14% sequentially in Q1-21 from Q4 of 2020. For Q1-22, we expect a larger sequential decline given the favorable Q4-21 changes to gross to net estimates that Johanna mentioned earlier. Nonetheless, we expect a strong year overall for our HIV business and continued growth in the subsequent quarters. Looking beyond Q1, we expect the impact of the Truvada and Atripla LOEs to be largely behind us starting in Q2, and we look forward to accelerating growth in our HIV business during the remainder of the year. For the full year 2022, we expect Vechlori sales of approximately $2 billion.

This is a normal dynamic for HIV due to inventory in seasonal pricing impacts and you'll recall that last year HIV revenue declined 14% sequentially in Q1, 'twenty one from Q4 of 2020.

For Q1, 'twenty, two we expect a larger sequential decline given the favorable Q4 'twenty one changes.

Gross to net estimates that Joanna mentioned earlier.

Unless we expect a strong year overall for our HIV business and continued growth in the subsequent quarters.

Looking beyond Q1, we expect the impact of the Truvada in a triple low will be largely behind us starting in Q2, and we look forward to accelerating growth in our HIV business during the remainder of the year.

For the full year 2022, we expect that jewelry sales of approximately $2 billion. This assumes as I previously indicated that Amazon will represent the only major search for the year with veterinary revenue heavily weighted in the first quarter.

Andrew Dickinson: This assumes, as I previously indicated, that Omicron will represent the only major surge for the year, with Vechlori revenue heavily weighted in the first quarter. That said, the pandemic continues to be dynamic, and we will update you on our Vechlori expectations on a quarterly basis, consistent with our recent preparation. We will update you on our Vechlori expectations on a quarterly basis, consistent with our recent preparation. Moving to the rest of the P&L, we expect our non-GAAP product gross margin to be approximately 85 to 86%, consistent with our historic guidance and allowing for the 3% royalty associated with the legal settlement.

That said the pandemic continues to be continues to be dynamic and we will update you on our victory expectations on a quarterly basis consistent with our recent practice.

Moving to the rest of the P&L, we expect our non-GAAP product gross margin to be approximately 85% to 86% consistent with our historic guidance and allowing for the 3% royalty associated with the legal settlement.

Andrew Dickinson: For non-GAAP operating expenses, we expect R&D to decline or to decrease by a mid-single-digit percentage compared to 2021 levels. This decline is driven by the net $625 million charge related to the ARCIS opt-in in the fourth quarter of 2021. Excluding this, we expect full-year R&D expense to increase by a mid- to high-single-digit percentage compared to 2021 levels. We expect SG&A expense to be approximately flat on a dollar basis compared to 2021.

Our non-GAAP operating expenses, we expect R&D to decline or to decrease by a mid single digit percentage compared to 2021 levels. This decline is driven by the net $625 million charge related to the ARCUS opt in in the fourth quarter of 2021.

Excluding this we expect full year R&D expense to increase by mid to high single digit percentage compared to 2021 levels.

We expect SG&A expense to be approximately flat on a dollar basis compared to 2021 or.

Andrew Dickinson: Our non-GAAP effective tax rate is expected to be approximately 20% this year. Finally, we expect our non-GAAP diluted EPS to be between $6.20 and $6.70 for the full year, and GAAP diluted EPS to be between $4.70 and $5.20. On capital allocation, our priorities have not changed. We continue to invest in our business, while at the same time, we returned over $4 billion in 2021 to our shareholders through dividends and share repurchases. In addition, we repaid $4.7 billion of debt in 2021. For 2022, we plan to repay $1.5 billion of debt, of which we repaid $500 million this morning.

Our non-GAAP effective tax rate is expected to be approximately 20% this year.

Finally, we expect our non-GAAP diluted EPS to be between $6 20.

$6 70 for the full year and GAAP diluted EPS to be between $4 70, and $5 20.

On capital allocation, our priorities have not changed we continue to invest in our business. While at the same time, we returned over $4 billion in 2021 to our shareholders through dividends and share repurchases.

In addition, we repaid $4 $7 billion of debt in 2021 for 2022, we plan to repay $1 5 billion of debt of which we repaid $500 million. This morning.

Operator: With that, I will invite the operator to begin the Q&A. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the back key.

With that I will invite the operator to begin the Q&A. Thank you.

Sure.

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the Bakken team.

Operator: We ask that you please limit yourself to one question, and if you have a follow-up, you may re-enter the queue. Please stand by while we compile the Q&A roster. Our first question comes from the line of Geoff Meacham from Bank of America. Your line is now- Okay, great.

So please limit yourself to one question and if you have a follow up you may reenter the queue.

Please standby, while we compile the Q&A roster.

Our first question comes from the line of Geoff Meacham from Bank of America. Your line is now open.

Okay, Great Hey, guys. Good afternoon, and thanks for the question.

Geoff Meacham: Hey guys, good afternoon. Thanks for the question. Dan or Andy, maybe a higher-level strategic question.

Dan or Andy maybe a higher level strategic question I wanted to ask about your comment regarding long term oncology sales.

Daniel O'Day: I wanted to ask you about your comment regarding long-term oncology sales. The question is, are you comfortable with the aggregate, you know, assets in the portfolio? Do you think you'll need to be more aggressive on BD, either to drive more near-term growth or to look longer-term to have, you know, higher-impact assets? Thank you very much.

The question is are you comfortable with the aggregate assets in the portfolio do you think youll need to be more aggressive on BD.

Either to drive more near term growth.

Or looking longer term.

Higher impact assets. Thank you very much.

Daniel O'Day: Thanks, Geoff. Thanks for the question and for teaming up. I'll start and then hand it over to Andy.

Thanks, Jeff Thanks for the questions are teeing it up I'll start and then hand it over to Andy So.

Yes.

<unk>.

The guide that we gave at Jpmorgan was that we are confident in our ability to two.

To grow and to also have oncology by 2030 be at least a third of our overall revenue on top of a.

A solid.

<unk>.

Business in virology business overall.

Daniel O'Day: So, yeah, I mean, the guide that we gave at J.P. Morgan was that we are confident in our ability to grow and to also have oncology by 2030 be at least a third of our overall revenue on top of a solid HIV business and virology business overall. I think the answer to the question, Geoff, is that we believe we have everything in-house to be able to fulfill that commitment today. I mean, the number of options that we have with Tredelvi, with Migrolumab, with the Arcus assets, and with cell therapy from an oncology base provides tremendous opportunities for us to look alone and in combination at that portfolio in the coming years.

To answer the question Jeff is we believe we have everything in house to be able to fulfill on that commitment today I mean, the number of options that we have with <unk> with <unk> with the ARCUS assets.

With cell therapy.

In oncology based provides tremendous opportunity for us to look alone and in combination of that portfolio.

In the coming years and that specifically.

Daniel O'Day: And that specifically leads to the more than 30 clinical trials we have ongoing right now in our oncology portfolio and our guideline that this year we'll start at least another 20 in the oncology space. So really, that's the arsenal behind our commitment and our growth. Of course, we'll continue to be opportunistic around business development and look for supplemental options out there that can complement this portfolio as a course of normal business, as any healthy company should. Having said that, we really do have enough in-house to be able to fulfill that commitment. So, with that, Andy, I may have stolen all your thunder, but I'm sure you'll have some additional perspectives. Please.

Leads to the more than 30 clinical trials, we have ongoing right now on oncology portfolio and our guide that this year, we'll start at least another 20.

The oncology space so.

Really that's the armamentarium behind our commitment and our growth of course, we will continue to be opportunistic around.

This development and look for supplemental options out there that can complement this portfolio is a course of normal business is there any healthy company should.

Having said that we really do have enough in house to be able to fulfill upon the commitment so that Andy.

I may have stolen all your Thunder, but I'm sure you will.

So some additional perspectives, we had Jeff. Thank you for the question.

Andrew Dickinson: Yes. Jeff, thank you for the question. I think it's an important question, especially in the context of the Migrolumab clinical hold that may be underpinning the question specifically. But the answer is relatively simple. We have a very strong set of assets already. The guidance that we provided at J.P. Morgan does not actually include all of the assets or all the indications for all of the assets.

I think it's an important question, especially in the context of the Mcgraw clinical hold that.

Maybe underpinning the question specifically, but the answer is relatively simple we have a very strong set of assets already the guidance that we provided at JP Morgan does not actually include all of the assets are all the indications for all the assets. So theres a lot of ways for us to get there we have complete confidence in where we're going and we don't expect to change our BD strategy as a result of any of the recent.

Andrew Dickinson: So, there are a lot of ways for us to get there. We have complete confidence in where we're going, and we don't expect to change our BD strategy as a result of any of the recent developments. We're actually really excited about where we are, and there's a lot of upside to that if other assets, whether it's some of the earlier Arcus assets or the Tizona or Pioneer assets, as examples, provide additional options for patients.

We're actually really excited about where we are and there is a lot of upside to that if other assets, whether it's some of the earlier, Arkansas assets or the designer or pioneer assets as examples.

Provide additional options for patients so when you're talking about high impact asset. So I would just summarize by saying we already think that we have a great portfolio of high impact assets in oncology, we're incredibly pleased with what we've put together and nothing that's happened recently is change that in any way. So thanks for the question.

Andrew Dickinson: So, when you talk about high-impact assets, I would just summarize by saying that we already think that we have a great portfolio of high-impact assets in oncology. We're incredibly pleased with what we've put together, and nothing that's happened recently has changed that in any way. So, thanks for the question. Thank you. All right. Our next question comes from the line of Mohit Bansal from Wells Fargo. Your line is now open.

Thanks Kimberly.

Our next.

Question comes from the line of Mohit Bansal from Wells Fargo. Your line is now open.

Hey, Thanks for taking my question and good afternoon.

Mohit Bansal: Great. Thanks for taking my question and good afternoon. Maybe a question for Merdad. So, in the light of new data that are emerging in HR quality when it comes to hard to negative breast cancer, did you have any updated thoughts on how to think about overall survival in the treatment and control arm for Probe XO2, vis-a-vis the expectation or the assumptions in clinical trials, which are, I think, if I'm not mistaken, 12 months for the control and 16 and a half months for the So how should we think about OS?

Maybe a question for Mike.

So in the light of new data that are emerging in HR positive <unk> negative breast cancer.

Do you have any updated thoughts on how to think about overall survival.

Treatment and control output products with two vis vis.

The expectation.

<unk> I think if im not mistaken 12 months for the control and 16 in Hoffman for the treatment.

How should we think about the Wes thank.

Thank you thank.

Merdad Parsey: Thank you. Thanks, Mohit. Directly over to you, Merdad. Yeah, thanks, Mohit. It's a great question, and I think, as I mentioned in my call, I think we're excited that we're going to be able to share the first interim analysis from the OS as well when we do the readout here for the PFS. So, I do think we'll look at both at the same time. You're absolutely right that there are developments in the HR positive space, but I continue to believe, and I think, you know, the impact on both PFS, on PFS in particular here, but also OS, continues to be, I think if we see something in the ballpark of what you just described, we're confident that that remains incredibly clinically relevant for people suffering from HR positive, HER2 negative.

Thanks, Mohit directly over to you yeah. Thanks, Matt that's a great question and I think as I mentioned in my call. I think we're excited that we're going to be able to share. The first interim analysis from the OS as well when we do the read out here for the PFS. So I do think we will look at both at the same time.

Absolutely right.

There are.

Developments in the HR positive space, but I continue to believe and I think.

I think that the.

Impact on both PFS and <unk>.

<unk> in particular, but also OS.

<unk> to be I think if we see something in the ballpark of what you. Just described we are confident that that remains incredibly clinically relevant for.

People suffering with with HR positive <unk> negative.

Merdad Parsey: It is, as you state, an increasingly competitive area, but we do think that that remains a key milestone for patients if we can achieve it. Thank you. Our next question comes from the line of 40 cast info from Stacy Morgan. Your line is now open.

It is as you state and increasingly competitive area, but we do think that that remains a key milestone for <unk>.

For patients if we can achieve that.

Thank you.

Our next question comes from the line of Cory <unk> from Jpmorgan. Your line is now open.

Hey, good afternoon, guys. Thank you for taking my question I wanted to follow up as well on the on the tropics <unk> study.

Operator: Hey, good afternoon, guys. Thank you for taking my question. I wanted to follow up as well on the Tropics02 study. And maybe, Merdad, can you talk about how you see the potential significance of this convergence of events that you alluded to when thinking about both progression-free survival and overall survival? Did you see any implications from this?

And maybe <unk> can you talk about how you see the potential significance of this convergence of events that you alluded to when thinking about <unk>.

Both progression free survival and overall survival did you see any implications from this or is this kind of.

Merdad Parsey: Or is this kind of moving along the lines as you would have expected it to? Thank you. Yeah, great question, and thanks for asking you. I think I'm very reassured.

Moving along the lines as you would expect it too thank you.

Merdad Parsey: I would not read anything into this other than the fact that we've been, as you can imagine, keeping track of the KFS events and the OS events all along. And, you know, we've now gotten to the point where those OS events have occurred in a time frame that allows us to look at both of these events at the same time. I don't think it really says anything about. I think what you're getting at is, does it have any implications for the underlying, you know, positive or negative or anything like that.

Yes, great question and thanks for asking it.

I think I am very reassured I would not read anything.

Into this other than the fact that we've been as you can imagine keeping track of the PFS events and the OS events all along.

And.

We've now gotten to the point, where those are less events.

Have occurred.

In a timeframe that allows us to look at both of these events at the same time I don't think it really says anything about I think what youre getting at is does it have any implications for the underlying.

Merdad Parsey: And I really, I really don't think there's any way to interpret that right now to be pure speculation to think that there's some, you know, some underlying driver of bringing those endpoints together, and actually, it's not that unexpected. It's a little bit closer than we thought it would be, but not by that much. So I wouldn't read too much into it.

Positive or negative or anything like that and I really I really don't think there's any way to interpret that right now it would be pure speculation to think that there is some.

Some underlying driver of bringing those endpoints together and actually it is not that unexpected it's a little bit closer in than we thought it would be but not not not by that much. So I wouldn't read too much into it I am just excited we'll be able to do it it will be a more robust look and I think as I've said before we think the regulators are going to want to see.

Merdad Parsey: I'm just excited we'll be able to do it. It'll be a more robust look. And I think, as I've said before, we think the regulators are going to want to see those robust looks at the OS to help them with the [inaudible] you know, sort of, in a sense, supporting the PFS endpoint. Thanks, Cory.

Those robust looks at the Pos.

Pos to help them.

With.

Sort of in a sense supporting the PFS endpoint.

Thanks, Corey can we have the next question please.

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

Operator: Can we have the next question, please? Our next question comes from the line of Brian Abrahams from RBC Capital Markets. Your line is now open.

Your line is now open.

Brian Abrahams: Hey guys, thanks so much for taking my question. I wanted to better understand the potential signals from Macrolumab. I think you guys have said that you haven't observed any clear AE trend. I'm curious, where's the disconnect versus what the FDA and investigator concerns are here? And maybe talk a little bit about the potential path to resolution, what additional safety data would be needed, and your level of confidence that you will reach a resolution. Thanks. That's great!

Hey, guys. Thanks, so much for taking my question I wanted to better understand potential signals from <unk>. I think you guys have said that you havent observed any clear trend curious where's the disconnect versus what the FDA an investigator concerns are here.

And maybe talk a little bit about the potential path to resolution what additional safety data would be needed in your level of confidence you will reach a resolution.

That's great. Thanks, Brian Thanks Corey.

Merdad Parsey: Thanks, Brian. Thanks, Corey. Yeah, I think so.

<unk>.

So.

Merdad Parsey: Look, I think the way to think about it is, you know, some of it. There have been a couple of events that the agency wants to make sure that they have a chance to look at the overall safety profile. I remain blinded to the safety data, so what is going on is we are gathering the safety data, and we're going to share it with the FDA and with the data monitoring committee.

Look I think I think the way to think about it is.

Some of there have been a couple of events that the agency wants to make sure that they have a chance to look at the overall <unk>.

Overall safety profile.

I remain blinded to the tune of safety data. So what is going on as we are.

Gathering safety data and we're going to share it with the FDA and with.

The data monitoring committee.

Merdad Parsey: I can tell you that, you know, we feel that these are temporary challenges right now and we're going to work through resolving them as quickly as possible. I don't think these challenges really shake our confidence in the portfolio overall, and our overall strategy hasn't changed.

I can tell you that.

We feel that these are temporary challenges right now and we're going to work through resolving it as quickly as possible.

I don't think these challenges really shake our confidence for the portfolio overall and our overall strategy Hasnt changed we are really committed to the macro development program and we think that it really continues to have the potential to really address.

Merdad Parsey: We're really committed to the Magrad development program, and we think it really continues to have the potential to address an important unmet medical need. Doing that is, you know, remember, these are very generally pretty sick patients and with that underlying illness, I think it's appropriate to be cautious and make sure that we're striking the right balance as we go forward, but we'll work through it by looking at the overall safety, the overall safety profile, Brian, and make sure that we are able to resolve those issues with the FDA.

An important unmet medical need.

The other thing I'd add is remember these are very generally pretty sick patients and with that underlying illness, I think it's appropriate to be cautious and make sure that we are striking the right balance as we go forward, but we will we'll work through it by looking at the overall.

Safety.

The overall safety profile, Brian and make sure that we.

Are able to resolve those issues with the FDA and Brian will keep you informed as that evolves. We have obviously a lot of patients on <unk> continue to be served by <unk>. So we have a sense of urgency and working with the agency around thank you very much Brian .

Merdad Parsey: And Brian, we'll keep you informed as that evolves. We have, obviously, a lot of patients on Magrolemat that continue to be served by Magrolemat, so we have a sense of urgency in working with the agency. Thank you very much, Brian.

Please.

Thank you. Our next question comes from the line of Solvay <unk> Richter from Goldman Sachs. Your line is now open.

Merdad Parsey: We have the next question, please. Thank you. Our next question comes from the line of Salveen Richter from Goldman Sachs. Your line is now open. Good afternoon.

Good afternoon. Thanks for taking my question you referred to the ARCUS portfolio can you just comment on what you're most excited about outside of ticket and when you might start the triplet study.

Salveen Richter: Thanks for taking my question. You referred to the ARCIS portfolio. Can you just comment on what you're most excited about outside of TIGID and when you might start the triplets? Sure. Merdad Bunchy's title, "Inaudible."

Sure Doug.

To start on that sure.

Merdad Parsey: You know, I think in addition to the digit asset, as you know, the adenosine portfolio, if you will, the two molecules, the two inhibitors of adenosine, both in terms of the synthesis inhibitors, CD73, as well as the receptor blocker, are really interesting to us. They're early programs, but we think that there is a real potential for those assets to provide significant upside to treatment, both in terms of lung cancer, where we think, you know, there's some trial that's ongoing that is looking at the addition of adenosine inhibition to TIGIT plus PD1, as well as in some of the indications that Archies is evaluating with monotherapy, in particular, pancreatic cancer.

In addition to the tissue asset as you know the the.

Adenosine portfolio, if you will the two molecules.

<unk> inhibitors adenosine both in terms of the synthesis inhibitors, CB 73, as well as the receptor blocker.

<unk> are really interesting to us their early programs, but we think that there is a real potential for those assets to provide.

Significant upside to two treatment both in terms of where.

In lung cancer, where we think.

There is some.

The trial that's ongoing.

Looking at the addition of.

<unk>.

Adenosine inhibition to <unk>, plus PD, one as well as in some of the indications that are considered evaluating with monotherapy in particular pancreatic cancer. So I think for US there are a number of opportunities there and the potential the broad potential of <unk> inhibitors to add onto.

Merdad Parsey: So, I think for us, there are a number of opportunities there, and the broad potential of adenosine inhibitors to add on to immuno-oncology in general, and TGIC plus PD-1 in particular, really strikes us as a really great opportunity that, hopefully, as the data mature, we'll be able to share more and really underpin the optimism we have around one of those programs. Right, and I think there was a question run at the start.

Immuno oncology in general and tissue plus PD one in particular.

Strike us as a really great opportunity that hopefully as the data mature we will we will be able to share more and really.

Underpinned.

The optimism we have around where those programs are headed.

And I think there was a question around when to start.

Merdad Parsey: [inaudible] Oh, and then the triplet study. Yeah, we haven't announced that yet. We need to work through some details. Thanks for reminding me, Dan.

And then the triplet study yes.

We haven't announced that yet we need to work through.

Some details thanks for reminding me, Dan we're working through some.

Merdad Parsey: We're working through some approaches. Really, the question here for us is how to go from the doublet, where we're really looking at a TIGID inhibitor being an unapproved agent, right? And then potentially bringing in a second unapproved agent.

Approach really the question here for US is how to go from.

The the doublet, where we're really looking at tissue inhibitor being.

Unapproved agent right.

Daniel O'Day: So we have to work through, in a sense, the regulatory complications of how we have to sequence and stage those studies to allow us to assess the contribution of components such that we can move forward aggressively. So we're working really closely with our Adenosine colleagues, our ARCIS colleagues, and we'll work through the regulatory pathways to make sure that we can get to robust phase 3 trials with those. So as we do so, we'll certainly share the timing and the pathways.

And then potentially bringing in a second.

Unapproved agent. So we have to work through in a sense that the regulatory complications of how we have to <unk>.

Sequence and stage those studies to allow us to assess the contribution of components such that we can move forward aggressively. So we're working really closely with our adenosine colleague our identity colleagues our ARCUS colleagues.

And we will work.

We will work through the regulatory pathways to make sure that we can get to robust phase phase III trials with those so as.

As we do so we'll certainly share that.

Timing in the pathway.

Daniel O'Day: And Salveen, the only thing I'd add on top of Merdad's very eloquent response is the potential to combine this attractive portfolio from Arcus with other medicines that we have within Gilead, including Tredelvi and possibly Megrolamab and others. So this combination of having access to PD-1, two-digit compounds, and two adenosines combined with Tredelvi provides a rich opportunity to look at rational-based combinations.

And so being the only thing I'd add on top of them are done very eloquent response has the potential to combined.

This attractive portfolio for Marcus with other medicines that we have within gilead, including <unk>, and possibly mid <unk> and others. So the combination of having access to a PD one to tissue compounds to identifying combined with <unk> provides a rich opportunity to look at rational dose combinations and we'll be getting more.

Daniel O'Day: And we'll be getting more into that as we do a deeper dive into oncology as a starting point in April, and then obviously throughout the year, we'll continue to update you on that. And it's one of the major reasons why opting in early was important to us because we can work really fluidly now across a very rich portfolio. And with the additional expertise and colleagues from Arcus, it really expands all of our potential in clinical science and beyond. Thanks, Salveen, for the question.

And of that as we do a deeper dive in oncology as a starting point in April and then obviously throughout the year, we'll continue to update you on that and it's one of the major reasons why Austin in early was important to us because we can work really fluidly now across a very rich portfolio.

And with the additional expertise and colleagues from ARCUS.

Really expands all of our potential in clinical science and beyond.

Thanks for the question can we have the next question. Please.

Our next question comes from the line of Michael Yee from Jefferies. Your line is now open.

Operator: Can we have the next question, please? Our next question comes from the line of Michael Yee from Jeffreys. Your line is now open.

Hey, thanks.

Michael Yee: Hey, thanks. Thanks for the question. I appreciate it.

Thanks for the question appreciate it may be back to more debt on <unk> appreciating that I know theres a lot of focus on this interim OS.

Love to give you the opportunity to perhaps frame expectations at an interim.

Interims have different conversations and theres different norms at different percentage of events that are accrued. So could you just explain what percent of events. This interim is based on <unk> actually expect to hit Stat. Sig. We're just expecting a trend of a few months, maybe just talk to that a bit because I think theres different implications of just an interim thank you yes.

Merdad Parsey: Maybe back to Merdaad on Tredelvy, appreciating that, you know, I know there's a lot of focus on this interim OS. I would love to give you the opportunity to perhaps, you know, frame expectations at an interim. You know, interims have different connotations, and there's different norms and different percent of events that have accrued.

Thanks, Michael and maybe just a suggestion as you answered Michael specific question it might be helpful for the whole audience to hear again kind of your overall view.

Merdad Parsey: So could you just explain what percent of events this interim is based on? Do you expect to hit Statsig, or do you expect in a trend? For a few months, maybe just talk about that a bit because I think there's different implications for just an interim.

<unk>.

This potential success.

Yeah, Michael It's a great question and I think thank you for asking it so as a reminder, I think.

Merdad Parsey: Yeah, Michael, and maybe just a suggestion as you answer a specific question, it might be helpful for the whole audience to hear again kind of your overall view. Michael, it's a great question, and I think, thank you for asking it.

From a PFS standpoint, the primary endpoint of this study we believe we're really well powered.

Merdad Parsey: So as a reminder, you know, I think from a PFS standpoint, the primary endpoint of the study, we believe we're really well-powered to detect a difference there. And as I'll remind folks, we did redesign this study a year ago in order to power the study adequately for OS as well. I would, I think, as excited as I am that we will be able to report out that first interim analysis, Michael, you're absolutely right on that. I would not expect statistical significance at this first interim analysis because it is relatively early in the timeframe that we're seeing.

To detect a difference there.

<unk>.

And as I'll remind folks we did redesign this study a year ago in order to power the study.

Quickly for OS as well.

I would.

I think as excited as I am that we that that we will be able to report out that first interim analysis, Michael Youre, absolutely right on that.

I would not expect statistical significance at this first interim.

Because it is relatively early in the in the in the timeframe.

That we're seeing so.

Merdad Parsey: So, my expectation is that, again, pending a positive outcome, that we are well-powered to see a PFS improvement at a statistically significant level, and the OS will be supportive data at that point that will give us directionality as to where we're headed. And then, you know, hopefully, subsequent to that, as the events accumulate, we'll see where we're headed with OS and down the road.

My expectation is that.

Again pending a positive outcome that we are well powered to see.

PFS improvement at a statistically significant level and the OS will be supportive data at that point that will give us directionality as to where we're headed and then.

Hopefully subsequent to that as the events accrue.

We'll see where we're headed with OS.

Down the road, it's a great question.

Thanks, Michael.

Operator: Thanks, Michael. Can we have the next question? Our next question comes from the line of Ronnie Gao from Bernstein. Your line is now open.

The next question please.

Our next question comes from the line of Ronny Gal from Bernstein. Your line is now open.

Ronnie Gao: Good afternoon, and thank you for taking my question. Switching over to talk a little bit about Yaskarta, can you tell us if there's already been impact on the use of Yaskarta in the second line, or is it still ahead of us? And you've mentioned you're increasing your capacity by 50%. Are you currently capacity constrained or demand constrained?

Good afternoon, and thank you for taking my question switching over to talk a lot about it yet Scott.

Can you tell us if there is already impact on the use of your Scott <unk> in second line or is this still ahead of us and you've mentioned you're increasing your passionate about 50% are you currently capacity constrained or demand constraints essentially all of that demand be used if it comes on line.

Daniel O'Day: Essentially, will all that demand be used if it comes online? Yeah, thanks, Ronnie. And as I turn it over to Christy, let me just say how, you know, how many patients we've been able to impact with cell therapy in 2021. And that being just the beginning of, I think, our promise for the future. We certainly invested in the manufacturing capacity to anticipate demand and success in the second line. And Christy can go into the details with you. Christy, over to you.

Yeah. Thanks Ronny.

Turn it over to Christy let me just say.

<unk>.

How many patients we've been able to.

Impact with cell therapy in 2021 and that being just the beginning of I think of our promise for the future. We certainly invested in the manufacturing capacity to anticipate demand and success in the second line and Kristie can go into the details with you Christy over to you.

Thanks, Dan Thanks for the question, Yes, we're very excited about not only the second line, which is the most important is to help the most patients but the continuing success of bovine plants with the five year data that was presented at Ash, where we are for your top 43% of wholesale still alive and at 44% of patients are alive at four years and 44.

Christy Schull: Thanks, Dan. Thanks for the question. Yeah, we're very excited about not only the second line, which is the most important and can help the most patients, but the continued success of third line plus with the five-year data that was presented at ASH, where at year four, you saw 43 percent of patients still alive, 44 percent of patients still alive at four years, and 43 percent at five years, which I think you heard Merdad say. So based on that, as well as new indications coming With our capacity, we're well positioned. You know, we have the El Segundo manufacturing site here in California.

Percent.

Five years, which I think you heard me say for both of those as well as new indications coming out we're really seeing an increase in demand or capacity.

We're well positioned we have also done though manufacturing site here in California, Amsterdam was approved during Covid and.

Christy Schull: Amsterdam was approved during COVID and was up to its capacity by the end of last year. And now we have the Maryland site, which will be going online in the first half of this year, where you'll see our automation as well. So not only increasing capacity but also the ability to reduce costs. So things are coming along nicely in terms of our ability to deliver. And, you know, we still have that reliability of 97 percent success when we give the cells back, which is so critically important to patients. So it's not a capacity issue.

With up to it.

Its capacity by the end of last year and now we have the Maryland side, which I will be going online in the first half of this year.

Youll see our automation as well so not only are increasing capacity, but also the ability to reduce costs.

Things are coming along nicely in terms of our ability to deliver.

No we still have that reliability of 97% success rate when we give the cells back which are so critically important propulsion, so not a capacity issue.

Christy Schull: You know, we had transparency a couple of issues last year where we had a scheduling issue where physicians were asking for the exact same slot all at the same time. And we quickly addressed that, and we no longer have that concern. So we're doing well in preparing for, hopefully, what we'll see is helping a lot more patients stay alive a lot longer. Thanks so much, Christy.

Transparency a couple of issues last year, where we had a scheduling issue where physicians are asking for the exact same spot all at the same Thailand.

Quickly address that.

And no longer have that concern so.

We're doing well in preparing for hopefully what we'll see is helping a lot more close in say a live a lot longer.

Daniel O'Day: And overall, Ronnie, we're expecting about a 50% increase in capacity over the course of 2022. Continued investment there. Thanks, Ronnie.

Thanks, so much Christine overall, Ronny, we're expecting about a 50% increase in capacity over the course of 2022 so.

Continued investment there. Thanks, Ronnie can we have the next question. Please.

Yes.

Our next question comes from the line of Colin Bristow from UBS. Your line is now open.

Operator: Can we have the next question, please? Our next question goes to the line of Colin Bristow from UBS. Your line is now open.

Hey, good afternoon, and thanks for taking the question.

Colin Bristow: Good afternoon, and thanks for taking the question. On the grown man, maybe you could explain why the multiple mile aimer and DLBCL trial, but also and hold, given their not in combination with Ava, and then just somewhat related to that. The dollar 50 in that position related expenses in the 22 guide, is there any component of that that's related to the 47 acquisition?

Great.

Explain why the multiple modeling.

<unk> trials, but also on hold given the not in combination with Asia, and then just somewhat related to that.

The $1 50 and acquisition related expenses in the 'twenty. Two guide is there any component of that that's related to the 47 acquisition. Thanks.

Great Andy.

Merdad Parsey: Thanks. Great. So we'll have Andy answer the second question.

And maybe you want to touch base on the first.

Also talking about the stage of those two trials.

Yes, it's really important.

Two.

This may have.

Not been entirely clear.

Merdad Parsey: Maybe you want to touch base on the first, Merdad, also telling us about the stage of those two trials. Yeah, yeah, it's really important to, I think this may not have been entirely clear. First of all, I think, look, I think whenever there's a safety question, the agency is going to err on the side of being cautious. And so we'll work through it with them on how to go forward. And I agree that in those studies; we are not combining it with azacitidine.

First of all I think look I think whenever there is a safety question. The agency is going to err on the side of being cautious.

So we'll work through with them.

On how to go forward and I agree and those studies, we're not combining with <unk>. So again I think as we as we share the data and the analysis with the agency hopefully we can come to resolution sooner than later.

Merdad Parsey: So, again, I think as we share the data and the analysis with the agency, hopefully we can come to resolution sooner than later. And it's important to note that for the multiple myeloma study, we actually hadn't really started enrolling patients at that point. So I think that was one consideration.

And it's important that.

To note that for the.

The multiple myeloma study, we actually hadn't really started enrolling patients at that point. So I think that was one consideration and by contrast for the <unk> study that study is completely enrolled.

Merdad Parsey: And by contrast, for the study, that says completely enrolled. So the partial hold there actually doesn't have much of a practical impact on that study because we're going to continue dosing the patients who are already enrolled in that study. So, you know, I think you should remember that the way it works is maybe the context here. The holds are placed on an IND, not on a study by study basis generally. So this was a hold to the IND.

So the partial hold there actually doesn't have much of a practical impact on that study because we're going to continue dosing the patients who are already enrolled in that study.

<unk>.

I think remember that where the way it works with maybe the context here. The holds are placed on an indie not on a study by study basis generally. So this was a hold to the IND and so that's sort of the context to think about it and I'll hand, it off to Andy to answer the second part of the question sure Hi Collyn.

Merdad Parsey: And so that's sort of the context to think about it. I'll hand it off to Andy to answer the second part of the question. Sure. Hi Colin.

Andrew Dickinson: I'm not sure that I fully understood the question, but what I can tell you is none of the updates that we provided in terms of the one-time fourth quarter expenses nor none of our 2022 guidance has anything to do with 47 expenses. So you and I can maybe talk separately to understand what your question is specifically, but there's nothing related to 47 or the 47 acquisition that was either part of our fourth quarter update, year-end update, or part of the 2022 guide specifically. Thank you. Thanks, Colin. Happy to take that up hybridly, too. So let's go to the next question, please. Our next question comes from the line of Hartash Singh from Oppenheimer. Your line is now open.

I'm not sure that I fully understood. The question, but what I can tell you is none of the none of the update that we provided in terms of the one time fourth quarter expenses, nor none of our 2022 guidance has anything to do with 47 expenses. So you.

You and I can maybe talk separately to understand what your question is specifically, but theres nothing related to <unk> 47 of the 47 acquisition that was either part of our fourth quarter update year end update or part of the 2022 guidance specifically.

Thanks, Paul and happy to take that up separately too. So let's go to the next question. Please.

Our next question comes from the line of hard Taj Singh from Oppenheimer. Your line is now open.

Operator: Hey, thank you everyone. Thanks for the question. This is just a question about Vic Laurier.

Hey, thanks, everyone. Thanks for the question.

Just a question on the glory youre, starting to get a pretty consistent franchise there.

Hartaj Singh: You know, you're starting to get a pretty consistent franchise there. I mean, unfortunately, COVID-19 is still out there. You know, various experts have indicated, even some of the companies we cover, we're going from a pandemic to an endemic kind of state this year into next year. How do you think of Vic Laurier, you know, going forward?

Unfortunately, COVID-19 is still out there.

Various experts have indicated and even some of the companies. We cover we're going from a pandemic to an endemic kind of state over this year into next year, how do we how do you think of the glory going forward I know, it's difficult to give guidance there, but you've got a year and a half worth of data underneath your belt are you thinking of hospitalizations going forward.

Johanna Mercier: I know it's difficult to give guidance there, but you've got a year and a half worth of data underneath your belt. How are you thinking of hospitalizations going forward? You know, whether that's through breakthrough infections, you know, or do you see as unvaccinated individuals get less and less, that hospitalizations will concomitantly decrease? Any thoughts there?

Through breakthrough infections or do you see it unlocks innate individuals get less and less.

Hospitalization won't can confidently decrease any thoughts there and then assuming the oral program gets approved how do you see.

The IV and the oral option.

Johanna Mercier: And then, assuming the oral program gets approved, how do you see, you know, remdesivir, IV, and then the oral option working together going forward? And again, thanks for the questions and a really nice answer. Thanks, Hratash. So, I think Johanna can start with some of the epidemic, and then Merdad could also comment a little bit on the forward portfolio, but please, Johanna, what do you think? Thanks, Hratash, for the question. Basically, what we've seen since the very beginning is how the glory sales truly track to hospitalizations.

Working together going forward and again, thanks for the questions in the next quarter.

So.

I think Joanna can start with some of the pandemic.

Endemic and then.

That could also come in a little bit on the forward portfolio, but please thanks.

Thanks very much for the question.

Basically what we've seen since the very beginning is how.

<unk> sales truly track to the hospitalizations and we've seen that most recently again with the omicron Serge.

Johanna Mercier: And we've seen that most recently, again, with the Omicron surge. What we did see as well is the fact that, despite the fact that Omicron seemed to have maybe a less severe impact, unfortunately, the number of cases was much greater. And therefore, just the pure absolute numbers of hospitalizations went up.

What we did see as well is the fact that.

Despite the fact that <unk> too.

You may be less severe impact unfortunately, the number of cases, where much greater and therefore, just the pure absolute numbers of hospitalization has went up.

Johanna Mercier: And so we've tracked every single time pretty much in line parallel to the hospitalization rates, and we assume that will continue. We do think the hospitalizations will get impacted by some of the oral compounds, even some of the outpatient use of Viclory, but also neutralizing antibodies, as well as oral treatments as well, like the PI from Pfizer.

And so we've tracked every single time pretty much in line parallel to the hospitalization rates I mean, we assume that we will continue we do think the hospitalizations will get impacted by some of the oral compounds, even some of the outpatient use of decorate that also neutralizing antibodies as well as the oral treatments as well like the <unk>.

From Pfizer and so we do think that will decrease hospitalizations over time. The one thing we had assumed maybe about a year ago, we really thought the vaccination rates would continue to rise and they didn't.

Johanna Mercier: And so we do think that'll decrease hospitalizations over time. The one thing we had assumed maybe about a year ago is that we really thought the vaccination rates would continue to rise. And they didn't, they basically stabilized them around the 60, 65% rate. And of course, there are variances across the country.

Johanna Mercier: So, what we've seen is the use of different treatments as well as vaccinations. The vaccination rates are really dictating a little bit of the kind of hospitalizations and, therefore, the usage, and yet again, in the December, January timeframe, we've really seen a critical role here for these hospitalizations, also having to do with the fact that many of the other previous agents that were on the market were no longer effective against the Omicron variant. And We haven't seen any of that.

They basically stabilized at around the 60% to 65% rate and of course, there are variances across the country. So what we've seen is the use of different treatments as well as the vaccinations vaccination rates are really dictating a little bit.

Kind of a hospitalizations and therefore, I think that clearly usage.

And yet again in the December January timeframe, we've really seen that clearly play a critical role here for these hospitalization.

Also having to do with the fact that many of the other previous agents that were on the market we're no longer.

We know that longer.

It is against the commentary yet and we haven't seen any of that we've seen very strong efficacy with that quarry, which is also help that I think most recently the outpatient data.

Johanna Mercier: We've seen very strong efficacy with Viclory, which has also helped that. I think most recently, the outpatient data that's come out in addition to the indication really plays a critical role when there are surges and hospitals are over capacity so that they really can look at the outpatient setting with Viclory. And we think that'll just kind of play hand in hand. And I would propose, as I turn it over to Merdad, to address the oral piece of the puzzle. I actually think you need both. I think you need the oral setting.

That's got to come out in addition to the indication really plays a critical role when Theyre searches and hospitals are overcapacity. So that they really can look at outpatient setting with declaration.

And we think that will just kind of play hand in hand, and I would propose as I turn it over to Marta to address the <unk> piece of the puzzle I actually think you need both I think you need the oral setting to Mark Moore.

Johanna Mercier: So more players in the oral setting are critical, and you still need hospitalizations because, unfortunately, if it does become endemic, I do think you'll see a steady rate of hospitalizations as we go through. And that's where Viclory plays a critical role. Merdad?

More players in the oral setting is critical and you still need hospitalizations because unfortunately.

If it does become endemic I do think Youll see a steady rate of hospitalizations as they go through and Thats perfect clearly plays a critical role Rita yes. Thanks.

Merdad Parsey: Yeah, thanks. And I guess I'd make two points. The first is that it is very early days with the oral program. And so I would keep that in mind. We just started phase one. So a lot of things can happen.

I'd make two points the first is.

It is very early days with the oil program and so I would I would keep that in mind. We just started phase one so a lot of things can happen and so I would just keep that in mind.

Merdad Parsey: And so I would just keep that in mind. Obviously, if things go well, we'll move as aggressively as possible. And I agree with Johanna.

Obviously, if things go well, we will move as aggressively as aggressively as possible and I agree with Joanna I think that there will always be a role.

For both oral and IV therapies that will be up.

Merdad Parsey: I think that there will always be a role for both oral and IV therapies. What we're seeing now, I think, in terms of how folks are approaching it, is that as the availability of oral therapies becomes broader, they're used relatively early in the course of disease. Many people may progress and or not get treated early enough and end up in the hospital. And at that point, I think that the role of IV therapies and chlorine, in particular, is going to come in.

What we're seeing now I think in terms of how folks are approaching it is that.

Availability of oral therapies becomes broader they are used relatively early in the course of disease.

Many people may progress and or not get treated early enough and then up in the hospital and at that point, I think thats, where that hospitalized or Perry hospitalization and more severe disease is where the role of IV therapy is going to come in and the clearing in particular is going to come in so too much to add to what <unk>.

Merdad Parsey: So I have too much to add to what Johanna said, but I do think there'll be a role for both in the long run. And Hortaje, just to compliment what Johanna and Merdad said, I think we clearly see that as this becomes endemic, there'll be... and potentially a need for multiple mechanisms in the outpatient setting. So that's one of the reasons why, you know, approaching it from a polymerase standpoint as well as the proteus standpoint, we think it could make sense over the long term for resistance patterns.

Joanna to it but I do think there'll be a role for both in the long run.

It does just to the <unk>.

Complement one Joanna and with that said I think we clearly see that.

As this becomes endemic that there'll be a potentially a need for multiple mechanisms in the outpatient setting. So that's one of the reasons why.

Approaching it from a preliminary standpoint as well as the Proteus standpoint, we think could make sense over the long term for resistance patterns.

Last thing I'll say is I think we've seen this rather its pandemic or epidemic.

Daniel O'Day: And the last thing I'll say is, whether it's a pandemic or not, Remdesivir is going to firmly entrench itself now as a standard of care in the hospital setting, and so as hospitalization goes, so will go remdesivir over time, and we think that's going to be an important part of our ongoing business and our benefit to patients. With that, thank you.

Industrial was going to firmly.

French now as the standard of care in the hospital setting and so as goes hospitalizations. So we'll go run that severe over time, and we think that's going to be an important part of our ongoing business in our benefit to patients.

With that thank you.

Operator: We'll move on to the next question, please. Our next question comes from the line of Carter Gould from Barclays. Your line is now: Great. Thank you. Good afternoon.

Move on to the next question please.

Yes.

Our next question comes from the line of partner goal from Barclays. Your line is now open.

Carter Gould: Thanks for taking the question. I wanted to come back to Tridelvy, but a little bit more from the commercial and strategic angle and wanted to, you know, just sort of the decision to triple the sales force. At this point, ahead of Tropics 2, is that decision dependent upon positive data from Tropics 2, or could that potentially be revisited depending on that outcome? And then specifically around sort of what you're seeing with the sales, it seems like the growth on an absolute basis, quarter on quarter, it does seem to be.

Great. Thank you. Good afternoon. Thanks for taking the question I wanted to come back to <unk>, but a little bit more from the commercial and strategic angle and wanted to just sort of a decision to triple the sales force at this point ahead of ahead of tropics too.

Is that decision dependent upon positive data from tropics, two or could that potentially be revisited depending on that outcome and then specifically around sort of what youre seeing in the sales it seems like that.

The growth on an absolute basis quarter on quarter, it does seem to be sort of.

Carter Gould: I'm slowing down a bit, can you maybe just talk about how the real world, you know, duration of use, has maybe evolved and if that's sort of in line with what you saw in the studies. Thanks, Carter. Right over to Johanna, please.

Slowing a bit can you maybe just talk about how the real world.

Duration of use has maybe evolved and if thats sort of in line with what you saw on the studies in the pivotal studies. Thank you.

Johanna Mercier: Sure, Carter. Thanks for the question. Just a couple of things. One is the footprint, the geographic footprint that we've just initiated with that ramp up and the tripling. It has really maybe three objectives.

Thanks, Carter right over to Joanna sure Carter, Thanks for the question.

Just a couple of things one is the footprint that geographic footprint that we've just initiated and that that ramp up and the tripling. It has really maybe three objectives one is to <unk>.

Their support our initial launches at both metastatic Mtc is wireless bladder that's definitely number one in that it stay here now.

Johanna Mercier: One is to further support our initial launches of both metastatic TNBC as well as bladder. That's definitely number one, and that is here and now. The potential to support a potential indication in HR positive, which is what you were referring to.

The potential to support.

Potential indication in HR positive, which is what you were referring to and the third one is also setting up for the future success of our total oncology portfolio.

Yes.

Assuming positive data of course with what we have decided to go for that.

Johanna Mercier: And the third one is also setting up for the future success of our total oncology portfolio. So, assuming positive data, of course, is what we've decided to go for. But having said that, even if that didn't play out, this is the right team for the future of Gilead Oncology. So that was the first part of your question.

But having said that.

Even if that Didnt play out with this is the right team for the future for Gilead oncology.

So that was the first part of your question.

Johanna Mercier: The second part of your question about the growth slowing, I actually think we're quite pleased, actually, as we got into Q4. What we've seen is the share really driving up post-NCCN breast guidelines update in September. And so we had a good data point about share. The last data point we have is October, and that's the one in four that you heard me talk about earlier.

The second part of your question about the growth slowing as we think we're quite pleased actually as we got into Q4, what we've seen is this.

Sure really drive up <unk> guidelines update in September and so we had good data point of share. The last data point, we have is October and Thats. The one in four that you heard me talk about earlier and so that doubling from where we were in April . So we were at about half of that share in second line and now we are at about 24, 25% share in second line, so a real nice growth.

Johanna Mercier: And so that's doubling from where we were in April. So we were at about half of that share in second line, and now we're at about 24%, 25% share in second line. So really nice growth on that front, and definitely more to come.

On that front and definitely more to come I think there is an incredible opportunity for <unk> in this patient setting, especially with the high unmet medical need and the incredible data that we have with <unk>, so more to come on that.

Johanna Mercier: I think there's an incredible opportunity for Tridelby in this patient setting, especially with the high medical need and the incredible OS data that we have with Tridelby. So more to come on that front. Terrific. Thank you so much, Carter. We can take one last question, everybody.

Terrific. Thank you so much Carter, we can take one last question everybody. Thank you.

Thank you. Our last question comes from the line of Matthew Harrison from Morgan Stanley . Your line is now open.

Operator: Thank you. Thank you. Our last question comes from the line of Matthew Harrison from Morgan Stanley. Your line is now open.

Matthew Harrison: Great. Good evening. Thanks for fitting me in.

Great. Good evening, Thanks for fitting me in just one clarification and one question so forth.

Merdad Parsey: Just one clarification and one question. So, Merdad, can you just clarify? It was unclear to me from your comments whether the FDA had asked for the OS data and that's why you were including this interim now for the filing or if that had been your plan all along. So, if you could just clarify, that would be great. And then, second, any comments you can make specifically around the stocking tailwind as well as the gross net tailwind that you had from HIV in the fourth quarter? Thank you. Thanks a lot, Matthew, and then Johanna.

<unk> can you just clarify it was unclear to me from your comments, whether the FDA had asked for the OS data and that's why you were including this interim now for the filing or if that had been your plan all along so if you could just clarify that would be great and then.

Any comments you can make specifically around.

The stocking tailwind as well as the gross to net tailwind that you had from HIV in the fourth quarter.

Merdad Parsey: Yeah, very quickly, I think, as I mentioned, we did upsize a study last year for OS because we've always believed, especially in HR positive, that having OS data is going to be important to support a file. It's not the primary endpoint, and we think it's going to be important, supportive data to go. So that didn't really have much to do with this confluence of events here.

Thanks Matthew.

Got it and then Joanne Yeah very quickly I think as I mentioned, we did upsize. The study last year for OSB, because we've always believed especially in HR positive having OS data are going to be important to support a file it's not the primary endpoint.

And we think it's going to be important supportive data to go so.

That didn't really have much to do with this confluence of events here.

Merdad Parsey: It's a fortuitous event in terms of timing here that will support our data. So hopefully, that answers your question. The FDA did not ask for it.

It's a fortuitous event in terms of timing here that will support our data. So hopefully the FDA did not ask for it.

Typically ask us for it I would say, it's always we're always going to take a look at OS with the first PFS data.

Data cut at this point.

Instead of doing a look and then an interim we're just going to do the PFS and the interim at the same time.

Merdad Parsey: The FDA didn't specifically ask us for it. No, it's always been, we were always going to take a look at OS with the first PFS data cut. At this point, in order, instead of doing a look and then an interim, we're just going to do the PFS and the interim at the same time. And Matthew, the second part of your question around the Q4 piece of the puzzle. So, as you well know, right, as you go into Q4, you usually have a bit of a seasonal inventory build and subchannel play, and then, of course, that bleeds out in Q1, In Q1, the other difference is, of course, you increase your co-pay support, your donut hole coverage, and so all those pieces, and your payer mix kind of changes in your first quarter.

And Matthew the second part of your question around Q4 piece of the puzzle. So as you well know right. As you go into Q4 are usually have a bit of a seasonal inventory build in some channel play and then of course that bleeds out in Q1. So that's one piece of the puzzle in Q1. The other differences of course, you increased your co pay support year donut hole coverage.

<unk>.

And so all those pieces in your payer mix kind of changes in your first quarter, having said that in addition to that there.

Johanna Mercier: Having said that, in addition to that, there was some favorability in Q4 of 2021 from a growth-to-net standpoint, which will then create an even bigger kind of decline in Q1, and that's what we were referring to, so hopefully that helps a little bit. It's a one-time thing in Q4, and it's just more around the comparison versus Q1 over Q4 as we get through the first quarter. And that's what I was trying to signal. Great job, Matthew.

<unk>.

Some favorability in Q4 of 2021 from a gross to net standpoint, which which will then create an even bigger kind of decline in Q1 and thats. What we were referring to so hopefully that helps a little bit it's a onetime thing in Q4.

And it's just more about the comparison versus Q1 over Q4 at least as we get through the first quarter.

Just trying to signal.

Daniel O'Day: And just want to, before I turn it over to Jackie, thank all of you for joining. From our perspective, we are really excited about the build that we've had at Gilead over the past two years and the team and the people that we have on board. We've got a lot to do this year, and we're really teed up for a good, strong year and a strong decade ahead with this portfolio. With that, Jackie, over to you.

Great Matthew and just want to before I turn over to Jacky. Thank all of you for joining from our perspective, we are really excited about the build that we've had at gilead over the past two years and the team and the people that we have on board, we've got a lot too.

<unk> this year and we're really teed up for a good strong year in a strong decade ahead with this portfolio could that Jackie over to you. Please.

Jackie Ross: Thank you, Dan, and thanks to our operator, Gigi, for your help today, and indeed to all of you for joining us. We appreciate your continued interest in Gilead and hope that you can join us for our virology deep dive scheduled for Thursday, the 17th of February. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching.....[inaudible] I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry. [music] Thank you for watching!

Dan and thanks to our operator for your help today and indeed all of you for joining US. We appreciate your continued interest in Gilead and hope that you can join us.

Apology deep dive is scheduled for Thursday, the 17th of February . Thank you.

This concludes today's conference call. Thank you for participating you may now disconnect.

Yes.

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Yes.

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Sure.

No.

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Operator: [inaudible] know, I don't know, I don't know [inaudible] I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry [inaudible] a lot of work to do, she's got a lot of work [inaudible] [music] [inaudible] [music] [inaudible] I don't know. I don't know. I don't know. I don't know.

Operator: [music] Good day, and thank you for standing by. Welcome to the Gilead fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen-only mode.

[music].

[music].

Good day, and thank you for standing by and welcome to the Gilead fourth quarter and full year 2021 earnings conference call.

Jackie Ross: 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 one 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 speaker today, Jackie Ross, VP of Investor Relations. Please go ahead.

All participants are in a listen only mode. 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 one on your telephone please.

Does the advisor 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 speaker today, Jackie Roth VP of Investor Relations. Please go ahead.

Thank you Gigi and good afternoon, everyone.

Jackie Ross: Thank you, Gigi, and good afternoon, everyone. Just after the market closed today, we issued a press release with earnings results for the fourth quarter and full year 2021. The press release, slides, and supplementary data are available on the investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Merdad Parsey, and our Chief Financial Officer, Andrew Dickinson.

Just after market close today, we issued a press release with earnings results for the fourth quarter and full year 2021, the press release slides and supplemental data are available on the investors section of our website at Gilead dotcom.

The speakers on today's call will be our chairman and Chief Executive Officer, Daniel O'day, Our Chief Commercial Officer, Joanna Mercy, a our chief Medical Officer, Murdock Pardon me and our Chief Financial Officer, Andrew Dickinson.

Daniel O'Day: After that, we'll open up the call to Q&A, where the team will be joined by Christie Schull, the Chief Executive Officer of KITE. Before we get started, let me remind you that we will be making forward-looking statements, including those 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, business, and operations, financial projections, and the use of capital, and 2022 financial guidance.

After that we'll open up the call to Q&A, where the team will be joined by Christi Shaw Chief Executive Officer Uptight.

Before we get started let me remind you that we will be making forward looking statements, including those related to the impact of the COVID-19 pandemic on Gilead business financial condition and results of operations plans and expectations with respect to products product candidates corporate strategy business and operations financial.

Daniel O'Day: All of these involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. 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.

Actions and use of capital and 2022 financial guidance.

All of these involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

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

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 in the earnings press release available on the Gilead website.

With that I'll turn the call over to Dan.

Thank you Jackie and good afternoon everybody.

Daniel O'Day: The GAAP to Non-GAAP reconciliations are provided in the earnings press release available on the Gilead website. With that, I'll turn the call over to Dan. Thank you, Jackie, and good afternoon, everybody. As we head into 2022, Gilead is coming off a year of positive clinical momentum and strong financial performance, mitigating the impact of the pandemic on some parts of our business. Higher sales of Aglori more than offset the impact of COVID-19 on HIV and HCV.

We head into 2020 to Gilead is coming off a year of positive clinical momentum and strong financial performance mitigating the impact of the pandemic on some parts of our business.

Higher sales of it clearly more than offset the impact of COVID-19 on HIV and HCV.

The group continues to play a critical role in helping to treat people with COVID-19 with continued activity against the omicron variant.

Daniel O'Day: Glory continues to play a critical role in helping to treat people with COVID-19, with continued activity against the Omicron variant. The FDA recently expanded its use beyond the hospital for patients at high risk of disease progression. In addition, we just initiated a phase one trial of GS5245, a novel oral COVID-19 nucleoside that once metabolized works in the same way as remdesivir. Our full-year revenue for 2021 was 11% higher than the midpoint of our initial guidance in February of 2021. It was also an important year for transformation to become a business that is based on diverse, sustainable growth.

The FDA recently expanded its use beyond the hospital for patients at high risk of disease progression.

In addition, we just initiated a phase one trial of <unk> five to four five <unk>.

A novel oral COVID-19 nuclear side.

It's metabolized works in the same way as <unk>.

Our full year revenue for 2021 was 11% higher than the midpoint of our initial guidance in February of 2021.

There was also an important year for our transformation to becoming a business that is based on diverse sustainable growth.

In 2021, we received seven approvals or accelerated approvals in the U S and Europe and submitted an additional six filings.

Daniel O'Day: In 2021, we received seven approvals or accelerated approvals in the U.S. and Europe and submitted an additional six filings. Our approvals included three for TRDELV with the FDA and M.A. approval in second-line triple negative breast cancer, as well as an accelerated approval from FDA for metastatic bladder cancer. Two for cell therapy, with Yaskarta receiving accelerated approval for relapse or refractory follicular lymphoma, and Ticardus receiving full approval for adult acute lymphoblastic leukemia, and two expanded labels in virology, one for a pediatric label for Bictarvy in the U.S. and an expanded label for Bicluri in the E.U. For adults not requiring supplemental oxygen

Our approvals included three Pritchard Lv with the FDA and MAA approval in second line Triple negative breast cancer as well as an accelerated approval from FDA for metastatic bladder cancer.

Two for cell therapy with you Scott are receiving accelerated approval in relapsed or refractory follicular lymphoma and to Carlos receiving full approval and adult acute lymphoblastic leukemia.

Two expanded labels in Barology, one for a pediatric label for big target in the U S and an expanded label for the clarity and the EU for adults not requiring supplemental oxygen.

Our 2022 plans include a significant increase in clinical development studies across our novel oncology portfolio.

Daniel O'Day: Our 2022 plans include a significant increase in clinical development studies across our novel oncology portfolio. We are planning at least 20 additional trials, including seven phase three trials for Tridaldi. And these include the ASCENT3 trial, which is evaluating Tordelvi in frontline AAA breast cancer in the PD-L1 negative population. He is sent for trial in collaboration with Merck to evaluate Trodelby and Koutrouda in the frontline triple negative breast cancer population, the PD-L1 positive population, and the EVOKE-III trial, which will be led by Merck, to evaluate Tordelvian contradrug in non-small cell lung cancer.

We are planning at least 20 additional trials, including seven phase III for trials for <unk>.

And these include the <unk> III trial, which is evaluating <unk> in the frontline triple negative breast cancer in the PD lone negative population.

We are set for trial in collaboration with Merck to evaluate <unk> controller in the frontline triple negative breast cancer.

Population in the PD lone positive population.

And the evoke three trial, which will be led by Merck to evaluate <unk> controller and non small cell lung cancer.

You will also see ongoing momentum in our virology portfolio as we continue to expand our leadership in anti viral therapies.

Daniel O'Day: You will also see ongoing momentum in our virology portfolio as we continue to expand our leadership in antiviral therapy. We are advancing our longer-acting HIV options with Lanacafavir at the foundation and look forward to potential regulatory decisions in 2022. If approved, lenacapavir would be the only HIV treatment option administered twice yearly.

We are advancing our longer acting HIV options, but Atlantic half of the year as the foundation and look forward to potential regulatory decisions in 2022.

If approved <unk> would be the only HIV treatment option administered twice yearly.

Daniel O'Day: In addition, we'll continue to drive progress across our broader virology portfolio, including hepatitis, COVID-19, and other emerging viruses. This is a really important time in Gilead's transformation journey. After consistent work to execute on our strategy and expand our portfolio over the last two years, you will increasingly start to see this play out in tangible results. We're confident that Gilead has all the elements in place for a strong year and a strong step.

In addition, we will continue to drive progress across our broader barology portfolio, including hepatitis COVID-19, and other emerging viruses.

This is a really important time and gilead transformation journey.

After the consistent work to execute on our strategy and expand our portfolio over the last two years.

Increasingly start to see this play out and tangible results.

We're confident that Gilead has all the elements in place for a strong year and a strong decade.

Joanna Mehrdad and Andy will now take you through the details of our progress in our plans.

Daniel O'Day: Johanna, Merdad, and Andy will now take you through the details of our progress in our plan. And let me first hand over to Johanna to talk about our commercial performance in the fourth quarter and the full year, and I'll be back to you in the Q&A.

Let me hand first over to Joanna to talk about our commercial performance in the fourth quarter and the full year and I'll be back to you in the Q&A Joanna.

Johanna Mercier: Thanks, Dan. Good afternoon, everyone. As you can see on slide 7, we had a strong end to the year with Q4 total product sales excluding declury of $5.8 billion, up 7% quarter over quarter, driven by favorable pricing and inventory dynamics. This also represented 8% growth year-over-year, driven by continued recovery in the HIV treatment market and favorable pricing dynamics. The clearing sales were higher than expected in Q4. We're selecting the start of the Omicron surge, but lower than both the prior quarter and prior year and contributing to total product sales of $7.2 billion.

Thanks, Dan Good afternoon, everyone.

As you can see on slide seven we had a strong end to the year with Q4, our total product sales, excluding declaration of $5 8 billion up 7% quarter over quarter, driven by favorable pricing and inventory dynamics.

It also represented 8% growth year over year, driven by continued recovery in the HIV treatment market and favorable pricing dynamics.

<unk> sales were higher than expected in Q4.

Reflecting the start of the omicron surge, but lower than both the prior quarter and prior year and contributing to total product sales of $7 2 billion for the quarter.

Moving to slide eight total fourth quarter Declaration sales were $1 4 billion, bringing total sales for 2021 to $5 6 billion.

Johanna Mercier: Moving to slide 8, total fourth-quarter veterinary sales were $1.4 billion, bringing total sales for 2021 to $5.6 billion. Gilead is proud of the role that VicLurie continues to play in this pandemic. VicLurie has demonstrated activity against the Omicron variant and has helped many patients with COVID-19 in the most recent.

Gilead is proud of the role that Victoria continues to play in this pandemic <unk> has demonstrated activity against the underground variant and has helped many patients with COVID-19, and the most recent search.

Johanna Mercier: Although symptoms have generally been less severe, the volume of overall cases has meaningfully increased since the emergence of Omicron, and we have seen the total number of hospitalizations increase as well. While we would all prefer to put this pandemic behind us, we expect the query to continue to play a critical role in 22 and beyond. As you'd expect, hospitalizations remain a key indicator for inpatient veterinary sales, and we're seeing higher hospitalizations in geographies with lower vaccination adoption, including certain parts of the U.S., as well as Eastern Europe.

Although symptoms have generally been less severe the volume of overall cases has meaning really increase since the emergence of omicron and we've seen the total number of hospitalizations increased as well.

While we would all prefer to put this pandemic behind us we expect the quarter to continue to play a critical role in 'twenty two and beyond.

As you would expect hospitalizations remain a key indicator for inpatient victory sales and we're seeing higher hospitalizations in geographies with lower vaccination adoption, including certain parts of the U S as well as eastern Europe .

Additionally, I'm very pleased to highlight that the FDA recently approved the SMB a filing for the use of victory in the outpatient setting for patients at high risk of disease progression.

Johanna Mercier: Additionally, I'm very pleased to highlight that the FDA recently approved the SNDA filing for the use of declarating in the outpatient setting for patients at high risk of disease. The approval was based on data generated in the Phase III pine tree study, further solidifying the credibility, importance, and role of vehicular. Now the inquiry will be able to help even more patients earlier and reduce the risk of hospitalization for COVID-19. Next, as shown on slide 9, total HIV sales were $4.5 billion in the corner.

This approval was based on data generated in the phase III Pine tree study further solidifying the credibility importance and role of victory.

Now clearly we will be able to help even more patients earlier and reduce risk of hospitalization for COVID-19.

Next as shown on slide nine total HIV sales were $4 5 billion in the corner.

Johanna Mercier: Up 8% sequentially driven by favorable inventory and pricing dynamics, as well as changes to our growth to net estimates in Q4 2021. For the full year, total HIV sales were $16.3 billion, down 4% year-over-year, primarily due to Travada and a triplet, L.O.E., in addition to pandemic-related impacts and pricing done. The expected impact from the LOEs, which amounted to $1.3 billion, was offset by continued Victorvi growth.

Up 8% sequentially, driven by favorable inventory and pricing dynamics as well as changes to our gross to net estimates in Q4 of 2021.

For the full year total HIV sales were $16 3 billion down 4% year over year, primarily due to the truvada in a triplet hello.

In addition to pandemic related impacts and pricing dynamics.

The expected impact from the low <unk>, which amounted to $1 3 billion was offset by continued Victor Harvey Chris.

Excluding the sizable low impact.

Johanna Mercier: Excluding the sizable LOE impact, HIV total product sales for the full year grew 4% compared to 2020, despite the ongoing pandemic headwind. We now expect the Travada Ngetripla loss of exclusivity impact to be minimal going forward as the headwind dissipates starting in Q2 of this year. In HIV treatment, we continue to see signs of market recovery, although the US market declined 1% sequentially in Q4 following two quarters of sequential growth. On a year-over-year basis, the overall marketing Q4 was up 1.5 percent in both the U.S. as well as EU5, despite screening and diagnosis rates still below pre-pandemic levels.

<unk> HIV total product sales for the full year grew 4% compared to 2020, despite the ongoing pandemic headwinds.

We now expect the Truvada and <unk> loss of exclusivity impact to be minimal going forward as the headwind dissipate starting in Q2 of this year.

In HIV treatment, we continue to see signs of market recovery, although the U S market declined 1% sequentially in Q4, following two quarters of sequential growth.

On a year over year basis. The overall market in Q4 was up one 5% in both the U S as well as EU five despite screening and diagnosis rates still below pre pandemic levels.

As you know favorable dynamics play out in the fourth quarter of every year and HIV in 2021 with no different with some yearend inventory stocking and favorable seasonal pricing as well as changes in our gross to net estimate in Q4 2021.

Johanna Mercier: As you know, favorable dynamics play out in the fourth quarter of every year in HIV, and 2021 was no different, with some year-in-stocking inventory and favorable seasonal pricing, as well as changes in our growth to net estimates in Q4 2021. As you think about 2022, I'll remind you of the normal HIV inventory buildup in Q4 and the new year reset for patient co-pays and donut hole payments. Given these factors, along with the favorable pricing dynamics I just mentioned, we've set the sequential declining Q122 to be greater than Q121. Nonetheless, we expect a strong year overall in HIV and expect continued growth in subsequent quarters. Back to Q4, Vic Tarvey had another record quarter with sales of $2.5 billion, up 11% sequentially and 22% year over year.

As you think about 2022, I'll remind you of the normal HIV inventory buildup in Q4, and the new year reset for patient co pays and donut hole payments given.

Given these factors along with the favorable pricing dynamics I just mentioned, we expect a sequential decline in Q1, 'twenty two to be greater than Q1, 'twenty one nonetheless.

We expect a strong year overall in HIV and expect continued growth in subsequent quarters.

Back to Q4, <unk> had another record quarter with sales of $2 5 billion up 11% sequentially and 22% year over year.

Johanna Mercier: On slide 10, you can see that the target U.S. treatment market share has increased by over five share points in 2021, reaching 42%, which is the highest share that any complete regimen has ever achieved in this season. For the full year, Biktarvy sales were $8.6 billion, growing 19% from 2020, and Biktarvy remains the leading prescribed treatment for naive and switched patients in the U.S., as well as number one in naive patients in the EU five. SCOBY revenue for the fourth quarter was $473 million, up 9% quarter-over-quarter, primarily as a result of favorable seasonal pricing and inventory dynamics, as well as continued demand.

On slide 10, you can see that Vitaros U S treatment market share has increased over five share points in 2021, reaching 42%, which is the highest share that any complete regimen has ever achieved in this market.

For the full year <unk> sales were $8 6 billion growing 19% from 2020, and <unk> remains the leading prescribed treatment for naive and switch patients in the U S as well as number one in naive in EU.

<unk> revenue for the fourth quarter with $473 million up 9% quarter over quarter, primarily as a result of favorable seasonal pricing and inventory dynamics as well as continued demand.

We expect to scobey revenue to continue to be driven by prep as the scobey has maintained about 45% of overall market prescriptions in the U S. We will continue to ensure access to support physician choice and expect growing demand and market expansion to offset the impact of increased commercial contracting.

Johanna Mercier: We expect DSCOVI revenue to continue to be driven by PrEP as DSCOVI has maintained about 45% of overall PrEP market prescriptions in the U.S., will continue to ensure access to support position choice, and expect growing demand and market expansion to offset the impact of increased commercial competition from other countries. Overall, while near-term growth continues to be impacted by local pandemic-related social restrictions, we're encouraged by the growing prep market. In Q4, the overall PrEP market grew 4% quarter-over-quarter and 31% year-over-year.

Overall, while near term growth continues to be impacted by local pandemic related social restrictions. We're encouraged by the growing market in Q4, the overall print market grew 4% quarter over quarter and 31% year over year looking forward, we believe <unk>, our investigational longer acting prep offering could potentially catalyze this <unk>.

Johanna Mercier: Looking forward, we believe lenacapavir, our investigational longer-acting PrEP offering, could potentially catalyze this market well beyond the 25% penetration rate in PrEP that we see today. Moving to slide 11, it's clear that HCV continues to be part of our portfolio most affected by the pandemic. Although there was some slight quarter-over-quarter recovery in market starts in the EU5, U.S. market starts declined, resulting in flat total starts overall.

Well beyond the 25% penetration rate in prep that we see today.

Moving to slide 11, it's clear that HCV continues to be part of our portfolio most impacted by the pandemic.

Although there was some slight quarter over quarter recovery market starts in the EU five U S market starts declined resulting in flat total starts overall.

While gilead market share increased modestly on a sequential basis in both the U S and the EU. This was more than offset by unfavorable pricing dynamics, resulting in Q4 total sales of $393 million down, 8% sequentially and 7% year over year.

Johanna Mercier: While Gilead market share increased modestly on a sequential basis in both the U.S. and the EU, this was more than offset by unfavorable pricing dynamics, resulting in Q4 total sales of $393 million, down 8% sequentially and 7% year-over-year. As you can see on slide 12, our HPV and HDD franchise reported record quarterly revenues of $265 million, up 7% sequentially due to seasonal inventory and favorable The 9% year-over-year growth was primarily driven by them, Lady Dimit.

As you can see on slide 12, our HBV in HDD franchise reported record quarterly revenues of $265 million up 7% sequentially due to seasonal inventory and favorable pricing the.

The 9% year over year growth was primarily driven by them Lady demand total fiscal year sales for this franchise were $969 million up 13% year over year.

Johanna Mercier: Total fiscal year sales for this franchise were $969 million, up 13% year-over-year. HEP GLUDEX reported $12 million of sales in Q4 in Europe, with $37 million in 2021 sales since our acquisition in late the first quarter. HEP Cludex is currently available in Germany and France, in addition to a number of early access programs in countries such as Austria, Italy, and Greece.

<unk> reported $12 million of sales in Q4 in Europe with $37 million in 'twenty, one sales since our acquisition in late first quarter <unk>.

<unk> is currently available in Germany in France. In addition to a number of early access program in countries, such as Austria, Italy and Greece.

In 2022, and as part of our comprehensive commercialization plan, we expect to finalize reimbursement for lunch and a number of major European market.

Johanna Mercier: In 2022, and as part of our comprehensive commercialization plan, we expect to finalize reimbursement for launch in a number of major European markets. In the U.S., we filed a BLA in November for an FDA-granted priority review for accelerated approval with the producer dates set for the third quarter, as well as an advisory committee meeting that will be scheduled in the coming. Moving to oncology, first with Tedali on slide 13, global sales of 118 million in the fourth quarter, up 17% sequentially, and up 84% year-over-year compared to full Q4 2020.

In the U S. We filed the BLA in November and FDA granted priority review for accelerated approval with a <unk> date set for the third quarter as well as an advisory committee meeting that will be scheduled in the coming months.

Moving to oncology first with <unk> on Slide 13, global sales were $118 million in the fourth quarter up 17% sequentially and up 84% year over year compared to full Q4 2020.

Johanna Mercier: This reflects growing adoption of the Second Line Metastatic TNDC indication, which was noted as a preferred regimen and in the NCCN Breast Guidelines updated in. We're also starting to see stronger unaided brand awareness, which is resulting in continued market share growth. In second line TNBC, Tredelby now captures approximately one in four new cancer starts in the U.S. We've expanded our oncology footprint globally, including tripling our U.S. headcount to further accelerate the penetration of Tredelby and prepare for a potential HR positive and HER2 negative. Additionally, EU approval for Tredelby was granted in late November 2021, and we've already seen strong momentum in France and Germany since their launch.

This reflects growing adoption of second line metastatic CNBC indication, which was noted as a preferred regimen in the NCC and breast guidelines updated in September .

We're also starting to see stronger unaided brand awareness, which is resulting in continued market share growth.

In second line <unk> to Adobe now captures approximately one in four new starts in the U S. We've.

We've expanded our oncology footprint globally, including tripling, our U S head count to further accelerate penetration of Qdoba and prepare for a potential HR positive in her two negative launches.

Additionally, EU approval for <unk> to Adobe was granted in late November 2021, and we've already seen strong momentum in France, and Germany since their launch.

Johanna Mercier: We plan to launch a number of new countries following key reimbursement decisions. Now, on slide 14, on behalf of Christy and the KITE team, cell therapy Q4 sales of $239 million reflected 47% year-over-year growth and 8% increased sequential growth. For the quarter, Yaskarta's sales of $182 million were up 41% year over year, driven by continued demand for Yaskarta in relapse or refractory large B-cell lymphoma and follicular lymphoma.

We plan to launch a number of new countries following key reimbursement decisions this year.

Now on slide 14 on behalf of Christie and the kite team cell therapy, Q4 sales of $239 million reflected 47% year over year growth and 8% increase sequentially.

For the quarter yesterday sales.

Of $182 million were up 41% year over year, driven by continued demand in relapsed or refractory large b cell lymphoma, and Follicular lymphoma, Jakarta sales of $57 million in the quarter reflected 68% year over year growth based on growing global demand for relapsed or refractory mantle cell lymphoma and early contribution for.

Johanna Mercier: Carter's sales of $57 million in the quarter reflected 68% year-over-year growth based on growing global demand for relapsed or refractory mantle cell lymphoma and early contribution for adult acute lymphoblastic leukemia in the U.S. As a reminder, FDA granted CARDIS approval for adult ALL in October. In just the first few months of launch, there has already been strong demand that we expect to continue in the coming quarters given the high unmet need.

Adult acute lymphoblastic leukemia in the U S.

As a reminder, FDA granted to Curtis approval in adult ALLL in October .

And just the first few months of launch there has already been strong demand that we expect to continue in the coming quarters, given the high unmet need.

Full year cell therapy sales of $871 million reflected 43% year over year growth driven by continued L. Bcl mcl demand globally as well as the new launches.

Johanna Mercier: Full-year cell therapy sales of $871 million reflected 43% year-over-year growth driven by continued LBCL and NMCL demand globally as well as the new launch. The strong growth we've seen with these recent launches reinforces our belief that cell therapy adoption will continue its positive momentum as more physicians understand the benefits for appropriate patients and therefore increase referral rates to treatment. Merdad will elaborate later, so I'll just quickly mention the impressive data KITE presented at ASH in December.

The strong growth we've seen with these recent launches reinforces our belief that cell therapy adoption will continue its positive momentum as more physicians understand the benefits for appropriate patients and therefore increase referral rates to treatment centers.

<unk> will elaborate later, so I'll just quickly mention the impressive data presented at Ash in December 43% overall survival rate after five years in third line <unk> patients.

Johanna Mercier: 43% overall survival rate after five years in third-line LBCLP. The Yaskara data ash not only highlighted the long-term real-world safety and efficacy profile in third-line LBCL but also in earlier lines of therapy... For Zuma 7 data in second-line LVCL, FDA has set a producer date of April 1st, when we hope Yaskarta will be granted approval. In the meantime, the kite team is ramping up manufacturing capacity to meet the anticipated demand. Kite expects the new Maryland facility to begin commercial operations by Q2.

<unk> data at Ash, not only highlighted the long term real world safety and efficacy profile in third line or Bcl, but also in earlier lines of therapy.

<unk> seven data in second line <unk> FDA has set a <unk> date of April one when we hope you start it will be granted approval.

In the meantime, the kite team is ramping up manufacturing capacity to meet the anticipated demand kind of expect the new Maryland facility to begin commercial operations by Q2.

Combined with the Amsterdam, and Elsa condo facilities, we expect increased operational capacity by up to 50% by the end of this year.

Johanna Mercier: Combined with the Amsterdam and Elsa Condo facilities, we expect increased operational capacity by up to 50% by the end of this. Christy is here with the team and available to take questions on cell therapy during our Q&A. In closing, our oncology sales were $1.25 billion in 2021, and we expect Robust Rose in the coming years. And so with that, I'll head over to Merdad for Pipe. And so, with that, I'll head over to Merad for Pipe.

Christy's here with the team and available to take questions on cell therapy during our Q&A.

In closing our oncology sales were $1 25 billion in 2021, and we expect.

Robust growth in the coming years, and so with that I'll hand, it over to Mary to add for pipeline update thanks, John and good afternoon, everyone.

Merdad Parsey: Thanks, Johanna, and good afternoon, everyone. Building on what both Johanna and Dan have said, the Gilead team rounded out a very strong 2021 with further progress across our portfolio. In 2021 alone, we began enrolling patients in 13 oncology, 13 virology, and four inflammation treatments. And we have recently shared the initial details of the ambitious development programs we're targeting for 2022.

Hello.

Joanna and Dan have said the Gilead team running out a very strong 2021 further progress across our portfolio.

In 2021 alone we began enrolling patients in 13 oncology 13, barology and for inflammation trials.

We recently shared the initial details of the ambitious development programs, we are targeting for 2022.

Merdad Parsey: As we look forward, we're confident that we have the foundation to continue to build a robust, diverse portfolio across our three focused therapeutic areas. First, on slide 16, VicLurie continues to play a vital role in the fight against COVID-19. It was the first approved treatment for patients hospitalized with COVID-19, and we recently expanded indication labels in the U.S. and the EU.

As we look forward, we are confident that we have the foundation to continue to build a robust diverse portfolio across our three focus therapeutic areas.

First on slide 16, the glory continues to play a vital role in the fight against COVID-19.

<unk> was the first approved treatment for patients hospitalized with COVID-19, and we recently expanded indication labels in the U S and the EU in December the European Commission approved variation to the conditional marketing authorization for <unk> for the treatment of COVID-19, and adults not on supplemental oxygen.

Merdad Parsey: In December, the European Commission approved a variation to the Conditional Marketing Authorization for VicLurie for the treatment of COVID-19 in adults not on supplemental oxygen, and last month, based on the data from the Phase III pine tree study, the FDA expanded the approval of the drug to include non-hospitalized patients at high risk for COVID-19 disease progression. These expanded indications speak to the activity of victory against the coronavirus variants we've seen so far, including them [inaudible]. We believe there will continue to be a need for glory delivered intravenously, especially for higher-risk patients. The potential for continued COVID-19 variants and infections highlights the need for more convenient oral formulations to expand the options for outpatients.

And last month based on the data from the Phase III <unk> study the FDA expanded the approval of inquiry to include non hospitalized patients at high risk for COVID-19 disease progression.

These expanded indications speak to the activity of <unk> against the coronavirus variance, we've seen so far including <unk>.

We believe we will continue to be a need for declaring delivered intravenously, especially for higher risk patients the.

The potential for continued COVID-19 variance and infections highlight the need for more convenient oral formulations to expand the options for our patients.

As such we've just initiated a phase one trial of <unk> 245, a novel oral COVID-19, nucleoside that once metabolized works in the same ways from that severe.

Merdad Parsey: As such, we've just initiated a Phase 1 trial of GS-5245, a novel oral COVID-19 nucleoside that, once metabolized, works in the same way as remdesivir. Pending data, the evolving pandemic landscape, and discussions with regulatory agencies, we're hoping to initiate a registrational trial before the end of the year. Moving to HIV on slide 17, we shared an overview of some of our long-term development activities a few weeks ago to highlight the diversity of our portfolio and how it targets the entire HIV life cycle.

Pending data the evolving pandemic landscape and discussions with regulatory agencies, we're hoping to initiate a registrational trial before the end of the year.

Moving to HIV on Slide 17, we shared an overview of some of our long acting development activities in a few weeks ago to highlight the diversity of our portfolio and how it targets the entire HIV lifecycle.

Merdad Parsey: We continue to believe that our investigational agent, Lennon Cavalier, is a unique and foundational asset given its potential for extended dosing in addition to the compelling efficacy and safety profile highlighted in Capella and Calibrate. Next, on Slide 18, you can see our current clinical efforts with long-acting HIV therapy. As previously announced, the phase two study evaluating the oral combination of lanocafavir with Merck's islatravir is on partial clinical hold.

We continue to believe that our investigational agent, let me kind of a there is a unique and foundational asset given its potential for extended dosing. In addition to the compelling efficacy and safety profile highlighted in the Capella and calibrate studies.

Next on Slide 18, you can see our current clinical efforts with long acting HIV therapeutics as previously announced the phase II study evaluating the oral combination of Atlantic <unk> with Merck's <unk> is on partial clinical hold.

Merdad Parsey: And Merck remains in discussions with the FDA on next steps for islatravir. In the meantime, we, at Gilead, continue to develop a number of other potential partner ages for Lena Caviveer in HIV treatment and look forward to sharing some more detail on these programs at our virology deep dive later this month. We remain confident and excited about Lana Caballero's future potential to deliver options for people living with HIV or those who could benefit from PrEP.

Merck remains in discussions with the FDA on next steps for <unk>.

In the meantime, we at Gilead continue to develop a number of other potential partner agents for lennar cabins youre in HIV treatment and look forward to sharing some more detail on these programs and our urology deep dive later this month.

We remain confident and excited about <unk> future potential to deliver options for people living with HIV, where those who could benefit from prep.

I wanted to be very clear that the recent clinical hold for Atlantic capital of your trials, which the FDA initiated in December is not associated with Atlanta copy of your molecule itself.

Merdad Parsey: I want to be very clear that the recent clinical hold for the lenacapavir trials, which the FDA initiated in December, is not associated with the lenacapavir molecule itself. Rather, the hold reflects concern about the compatibility of certain vials with the Lenacapavir solution.

Rather the hold reflects concerned about the compatibility and certain vials with Atlantic <unk> solution.

Merdad Parsey: We continue to work with the FDA to remediate the concern and to agree on a path to resume these trials. We're hopeful this can be achieved quickly. As such, we continue to expect an FDA decision for Lenacapavir and heavily treatment-experienced individuals in the first half of 2020. If successful, Lenacapavir will become the first available six-month long-acting subcutaneous injection for the treatment of HIV.

We continue to work with the FDA to remediate the concern and to agree on a path to resume these trials.

Were hopeful this can be achieved quickly as such we continue to expect an FDA decision for <unk> in heavily treatment experienced individuals in the first half of 2022.

Successful lending category will become the first available six months long acting subcutaneous injection for the treatment of HIV.

Next moving to <unk> on slide 18, I am pleased to confirm that we now expect to share both top line progression free survival data as well as the first planned interim analysis of our overall survival from tropics <unk> in March.

Merdad Parsey: Next, moving to Tredelvia on slide 18, I'm pleased to confirm that we now expect to share both top-line progression-free survival data as well as the first planned interim analysis of our overall survival from Tropics 02 in March. There has been a convergence of events from PFS and OS, such that we'll be able to conduct and report a single analysis of these outcomes, rather than have two analyses separated by a short interval. Gilead remains blinded to the data, and we're excited to be able to share this more complete view later this quarter.

Theres been a convergence of events for PFS and OS such that we will be able to conduct and report a single analysis of these outcomes rather than have to analysis separated by a short interval.

Gilead remains blinded to the data and we're excited to be able to share. This more complete view later this quarter.

We are targeting an SPL a filing in the second half of 2022, depending of course on the readout.

If the data are positive we believe that <unk> could represent a very important treatment option for HR positive <unk> negative patients who are hormone refractory and have very limited options.

Merdad Parsey: We are targeting an SBLA filing in the second half of 2022, depending, of course, on the reading. If the data are positive, we believe that Trudeldi could represent a very important treatment option for HR positive patients who are home-run refractory and have very limited options.

Reflecting our confidence in <unk> overall, we're expanding the number of clinical programs in 2022 to evaluate effectiveness in breast lung and bladder cancers with plans to initiate study startup activities for at least seven phase III trials.

Merdad Parsey: Reflecting our confidence in TRODELV overall, we're expanding the number of clinical programs in 2022 to evaluate effectiveness in breast, lung, and bladder cancers with plans to initiate study startup activities for at least seven phase three trials. Three of these are expected to enroll their first patients in 2022, including two in frontline metastatic TMBC and another in frontline non-small cell lung cancer studies that will be led by Merck. Going forward, we will separately disclose trial startup activities versus FPI milestones.

Three of these are expected to enroll their first patient in 2022, including two in frontline metastatic <unk> and another in frontline non small cell lung cancers studies that.

That will be led by Merck.

Going forward, we will separately disclose trial startup activities versus Spi milestones.

Merdad Parsey: Additionally, in the first half of this year, we plan to add a combination of Tridelby with other Gilead portfolio assets as a study or an additional cohort in an existing study. We look forward to sharing more details at our upcoming Oncology Deep Dive in April. This is another example of the versatility and tremendous potential that Tridelby, along with the growing oncology portfolio, can generate. Now, slide on to migrolima

Additionally, in the first half of this year, we plan to add a combination of <unk> with other gilead portfolio assets as a study or an additional cohort in an existing study.

We look forward to sharing more details at our upcoming oncology deep dive in April .

This is another example of the versatility and tremendous potential that <unk> <unk>, along with a growing oncology portfolio can generate.

Next slide onto Monroe in that early last week, the FDA placed a partial clinical hold pausing enrollment and screening and trials in cohorts in the U S. Evaluating <unk> in combination with Decitabine. Following a review of our preliminary data, suggesting an apparent imbalance and investigator reported <unk> or unexpected.

Merdad Parsey: Early last week, the FDA placed a partial clinical hold pausing enrollment and screening in trials and cohorts in the U.S. evaluating migrolimab in combination with azacitidine following a review of a preliminary data set suggesting an apparent imbalance in investigator-reported SUSARs, or unexpected, sorry, suspected, unexpected, serious adverse reactions, between treatment groups in our ongoing phase three trial in high-risk MDS. A subsequent partial clinical hold has been placed on the Phase 2 Multiple Myeloma Study and the fully enrolled Phase 2 DLDCL Study.

Sorry suspected unexpected serious adverse reactions.

Between treatment groups and our ongoing phase III trial in high risk Mds.

The subsequent partial clinical hold has been placed on the phase II multiple myeloma study in the fully enrolled phase III <unk> study.

Merdad Parsey: Importantly, patients currently enrolled in our MacrolaMap studies can continue treatment, and our compassionate youth programs remain open. We're working with the FDA to take a comprehensive look at the safety data, and we'll share the outcome as quickly as we can. In the meantime, we're going to remain committed to the McGrollamab Development Program and believe that it has the potential to address an important unmet medical need in these seriously ill-paked patients... As you know, the patients in our Enhanced Phase III trial have a very high unmet need, with a median overall survival of only one to three years on the current standard of care. Separately from and prior to the partial clinical hold, our Phase 1b single-arm study in high-risk MDS no longer has a viable path to submission based on regulatory feedback.

Importantly patients currently enrolled in arm, a gorilla math studies can continue treatment and our compassionate use programs remain open.

We are working with the FDA to take a comprehensive look at the safety data and will share the outcome as quickly as we can.

In the meantime, we remain committed to the Monroe amount development program and believe that it has the potential to address an important unmet medical need in these seriously ill patients.

As you know the patients in our enhanced phase III trial have a very high unmet need with a median overall survival of only one to three years on the current standard of care.

Suffered from in prior to the partial clinical hold our phase <unk> single arm study in higher risk Mds no longer has a viable path to submission based on regulatory feedback.

Merdad Parsey: As such, we'll remain focused on our Phase III Enhanced Study and look forward to sharing the 1B data at an upcoming scientific meeting. Next, we move to cell therapy on slide 21. On behalf of Christy and the CHITE team, I'll share a brief update on the impressive data CHITE presented at ASH last December. First, as you may recall, in 2020, we shared that Yaskarta had a four-year overall survival rate of 44% in third-line LBCL patients.

As such we remain focused on our phase III enhance study and look forward to sharing the <unk> data in an upcoming scientific meeting.

Next moving to cell therapy on slide 21 on behalf of Christiana Mackay team I'll share a brief update on the impressive data presented at Ash last December .

First as you may recall in 2020, we shared that <unk> had a four year overall survival rate of 44% and 39 <unk> patients.

Merdad Parsey: At ASH in December, we presented five-year data from Zuma 1 and third-line LVCL patients showing Yaskarta demonstrated a remarkable and durable 43% overall survival rate, stable since our four-year opportunity. Additionally, 92% of the patients who remained alive at five years have not needed any additional cancer treatment since their one-time infusion of Yescarta. It's truly inspiring to see this type of durability for Karkie South there. As announced yesterday, the FDA approved a label update for Yaskarta to include the use of prophylactic corticosteroids across all approved indications. Adding prophylactic steroid use can improve the management of certain side effects without compromising the activity of the escargot.

At Ash in December we presented five year data from Zuma, one in third line <unk> patients showing us garner demonstrated remarkable and durable 43% overall survival rates stable since our four year update.

Additionally, 92% of the patients who remained alive at five years have not needed any additional cancer treatments since they're onetime infusion of <unk> cargo.

It's truly inspiring to see this type of durability for car T cell therapies.

As announced yesterday, the FDA approved a label update for <unk> to include use of prophylactic corticosteroids across all approved indications adding.

Having prophylactic steroid use can improve the management of certain side effects without compromising the activity of U S cargo.

Merdad Parsey: For example, the FDA label now shows no grade 3 or greater cytokine release syndrome events occurred using the Cohort 6 protocol as compared to 13% in the original label. This label update complements data published in 2021 showing 68% of patients had no CRS or neurological events within 72 hours of the Ascarta infusion. As we looked at earlier lines of treatment, the landmark ZUMA 7 trial evaluating Yaskarta and second-line relapsed refractory LBCL demonstrated a greater than fourfold increase in median event-free survival, or EFS, compared to standard of care through two years of follow-up. As you can see on the slide, the EFS curve for Yaskarta is compelling.

For example, the FDA label now shows no grade three or greater cytokine release syndrome events occurred using the cohort six protocol as compared to 13% in the original label.

This label update compliments data published in 2021, showing 68% of patients had no crs or neurologic events within 72 hours of use garden infusion.

As we look to earlier lines of treatment. The landmark Zuma seven trial evaluating <unk> in second line relapsed refractory <unk> demonstrated a greater than four fold increase in median event free survival or PFS compared to standard of care through two years of follow up.

As you can see on the slide the <unk> current for against Garda is compelling the SBA was filed last quarter and we expect an FDA decision by April of this year.

Merdad Parsey: The SBLA was filed last quarter, and we expect an FDA decision by April of this year. In terms of the first-line LBCL data, Yaskarta demonstrated 89% overall response rate in high-risk patients and 78% complete response with a medium follow-up of 15.9 months. Given these encouraging data, the KITE team is in discussions with regulatory authorities on a potential path forward for frontline LBCL. And finally, on Slide 22, we highlight the key 2022 catalysts across the portfolio, one of which I've just mentioned.

In terms of the first line <unk> demonstrated 89% overall response rate and high risk patients and 78% complete response with a median follow up of $15 nine months.

Given these encouraging data the kite team is in discussions with regulatory authorities on a potential path forward in frontline <unk>.

And finally on slide 22, we highlight the key 2022 catalysts across the portfolio many of which I've just mentioned.

Merdad Parsey: I'd also like to take a moment to highlight the three ARCIS milestones in the second half of this year. Last quarter, Gilead chose to opt into the three-archage programs, which added four assets to our portfolio. Tom Manila-Mab, NFC Silent Anti-Tigid Antibody, AB-308, NFC Active Anti-Tigid Antibody, trumadenant, an adenosine receptor antagonist, and quimiliclisat, a small molecule CD73 inhibitor.

I'd also like to take a moment to highlight the three ARCUS milestones in the second half of this year.

Last quarter Gilead opted into the three ARCUS programs, which added four assets to our portfolio, Jon Mcneill amount FC silent anti <unk> antibody <unk> hundred eight and FC active anti <unk> antibody.

<unk> and adenosine receptor antagonist and.

And with that the small molecule <unk> 73 inhibitor.

Merdad Parsey: Together with ARCIS, we expect to share ARC-VII Phase II PFS data in the second half of 2022, which will include data for the Zimbarella MAP monotherapy, ZIM and DOM doublets, as well as the ZIM, DOM, and Atruma triplet RNA. We look forward to sharing data when available and are very excited to collaborate more closely with ARCIS to accelerate future development. On slide 23, you can see the Gilead Sportfolio now encompasses 55 clinical stage programs, nearly doubling since 2019. Given the exciting potential of our portfolio across virology, oncology, and early-stage inflammation assets, this is just the beginning.

Together with ARCUS, we expect to share our seven phase II PFS data in the second half of 2022, which will include data for the zimbra around that monotherapy.

Jim and Don Doublet, as well as the Zim, Dom and <unk> triplet arm.

We look forward to sharing data when available and are very excited to collaborate more closely with ARCUS to accelerate future development plans.

On Slide 23, you can see the Gilead portfolio now encompasses 55 clinical stage programs nearly doubling since 2019.

Given the exciting potential of our portfolio across Barology oncology and early stage inflammation assets. This is just the beginning.

Merdad Parsey: Our teams are committed to advancing the most promising programs that will help transform patient outcomes, and we look forward to sharing our progress with you over the coming quarters and years.

Our teams are committed to advancing the most promising programs that will help transform patient outcomes and we look forward to sharing our progress with you over the coming quarters and years.

With that I'll hand, it over to Andy.

Andrew Dickinson: Thank you, Merdad, and good afternoon everyone. It was a strong close to 2021, driven primarily by Strong HIV and Veclory revenue in the fourth quarter. For the full year and excluding the impact of Eloise, HIV grew 4% year-over-year, driven by the continued outperformance of Bittarvi, which achieved record U.S. market share of 42% and sales of $8.6 billion, up 19% from 2020.

Thank you Marie and good afternoon, everyone.

It was a strong close to 2021% driven primarily by strong HIV and <unk> revenue in the fourth quarter.

For the full year and excluding the impact of the Eloise HIV grew 4% year over year, driven by the continued outperformance of <unk>, which achieved record U S market share of 42% and sales of $8 $6 billion up 19% from 2020.

Andrew Dickinson: Oncology was another highlight from both a pipeline and a revenue perspective, with full-year cell therapy sales of $871 million, growing 43% from 2020, and Tredelvi sales of $380 million in its first full year. By 2030, we anticipate our oncology franchise will represent at least a third of our total revenue. Before I get into the normal P&L review and 2022 guidance, I want to address the EPS results for this quarter up front

Apology was another highlight from both the pipeline on a revenue perspective with full year cell therapy sales of $871 million growing 43% from 2020, and <unk> sales of $380 million in its first full year by 2030, we anticipate our oncology franchise will represent at least a third of our total revenue.

Before I get into the normal P&L review in 2020 to guidance I wanted to address the EPS results for this quarter upfront.

Andrew Dickinson: Slide 25 highlights two sizable expenses that occurred after we gave our last guidance update in October. First, and subsequent to the exercise of Gilead's opt-in to four Arcus assets in December, our fourth quarter results reflect a net charge of $625 million recorded for R&D. This charge reflects our $725 million option payment recognized in Q4, less $100 million that was previously accrued.

Andrew Dickinson: This impacted our EPS by about 38 cents in Q4 and for the full year. Second, and as part of a legal settlement with VEVE and related parties, we have agreed to make a one-time $1.25 billion payment in addition to an ongoing 3% royalty for future sales of Biktarvy and the Biktagravir component of any Biktagravir-containing products in the United States. This royalty extends until October 5 of 2027.

Slide 25 highlights two sizable expenses that occurred after we gave our last guidance update in October .

First and subsequent to the exercise of Gilead to opt into four ARCUS assets in December our fourth quarter results reflect a net charge of $625 million recorded in R&D.

This charge reflects our $725 million option payment recognized in Q4 less $100 million that was previously accrued.

This impacted our EPS by about 38 in Q4 and for the full year.

Second and as part of a legal settlement with <unk> and related parties. We have agreed to make a one time $1 $25 billion payments. In addition to an ongoing 3% royalty for future sales of Harvey and the dictator of your component of any <unk> containing products in the United States.

This royalty extends until October five of 2027.

Andrew Dickinson: The $1.25 billion payment is recorded in our fourth quarter results and reflected in our cost of good souls. This charge constituted an approximately 17% impact on the gross margin in the fourth quarter, and it impacted our EPS by 80 cents for Q4 2021 and the full year. Going forward, we expect the impact of this new royalty to be approximately 1% on our gross margin, starting in the first quarter of 2022. Excluding these items and their combined $1.18 impact, our full-year non-GAAP EPS would have exceeded the guidance range that we set back in October, helped by stronger-than-expected Vicklery sales.

The $1 $25 billion payment is recorded in our fourth quarter results and reflected in our cost of goods sold.

This charge constituted an approximately 17% impact the gross margin in the fourth quarter and it impacted our EPS by <unk> <unk> for Q4, 2021, and the full year.

Going forward, we expect the impact of this new royalties to be approximately 1% on a gross margin starting in the first quarter of 2022.

Excluding these items and their combined $1 18 and impact our full year non-GAAP EPS would have exceeded the guidance range that we set back in October helped by stronger than expected in February sales.

Moving back to our quarterly review on Slide 26 fourth quarter revenue in our base business included HIV product sales growth of 7% year over year and 8% sequentially.

Andrew Dickinson: Moving back to our quarterly review on slide 26, fourth quarter revenue in our base business included HIV product sales growth of 7% year-over-year and 8% sequentially. Baclori sales were higher than expected due to the start of the Omicron surge.

<unk> sales were higher than expected due to the start of the omicron Serge non-GAAP product gross margin was 75% impacted by the legal settlement that I referenced earlier and non-GAAP R&D was impacted by the ARCUS, often resulting in non-GAAP EPS of <unk> 69 per share.

Andrew Dickinson: Non-GAAP product gross margin was 70.5%, impacted by the legal settlement that I referenced earlier, and non-GAAP R&D was impacted by the ARCIS opt-in, resulting in non-GAAP EPS of 59 cents per share. Our non-GAAP effective tax rate for the fourth quarter was 32.2%, reflecting tax expense related to uncertain tax positions and an increase in valuation allowance, as well as the impact of discrete tax benefits related to legal settlements with tax authorities in 2020 that did not recur this year.

Our non-GAAP effective tax rate for the fourth quarter was 32, 2%, reflecting tax expense related to uncertain tax positions and an increase in valuation allowance as well as the impact of discrete tax benefits related to legal settlements with tax authorities in 2020 that did not recur this year.

Andrew Dickinson: For the full year, on slide 27, total product sales of $27 billion grew 11% driven by Vic Lurie. Excluding Vecluri, total product sales were roughly flat at $21.4 billion as growth in BicTarVie and oncology offset the $1.3 billion impact of Truvada and A-triplet LOEs in the United States. I touched on the main P&L impacts in the fourth quarter discussion, but I'll highlight that our non-GAAP effective tax rate for 2021 was 20.4% despite the higher effective tax rate in the fourth quarter.

For the full year on slide 27, total product sales of $27 billion grew 11% driven by <unk> <unk>.

Excluding vexillary total product sales were roughly flat at $21 4 billion as growth in big <unk> and oncology offset the $1 3 billion impact of the Truvada and <unk> in the United States.

I touched on the main P&L impacts in the fourth quarter discussion, but I'll highlight that our non-GAAP effective tax rate for 2021 was 24% despite the higher effective tax rate in the fourth quarter.

Moving now to slide 28, our 2022 guidance assumes that the recent Amazon surge represents the only major COVID-19 wave for 2022 and in our HIV business will continue to recover from the pandemic.

Andrew Dickinson: Moving now to slide 28, our 2022 guidance assumes that the recent Omicron surge represents the only major COVID-19 wave for 2022 and that our HIV business will continue to recover from the pandemic. With that in mind, we expect product sales in the range of $23.8 to $24.3 billion.

With that in mind, we expect product sales in the range of 23, 8% to $24 3 billion.

Excluding that clarity, we expect product sales in the range of 21, 8% to $22 3 billion.

Andrew Dickinson: Excluding Becklery, we expect product sales in the range of $21.8 to $22.3 billion, representing growth of 2% to 4% for our base business year over year. Relative to Q1, I'll remind you to expect HIV revenue to decline sequentially. This is a normal dynamic for HIV due to inventory and seasonal pricing impacts. And you'll recall that last year, HIV revenue declined 14% sequentially in Q1-21 from Q4 of 2020. For Q1-22, we expect a larger sequential decline given the favorable Q4-21 changes from gross to net estimates that Johanna mentioned earlier.

Representing growth of 2% to 4% for our base business year over year.

Relative to Q1, I'll remind you to expect HIV revenue to decline sequentially.

This is a normal dynamic for HIV due to inventory in seasonal pricing impacts and you'll recall that last year HIV revenue declined 14% sequentially in Q1, 'twenty one from Q4 of 2020.

For Q1, 'twenty, two we expect a larger sequential decline given the favorable Q4 'twenty one changes to.

Gross to net estimates that Joanna mentioned earlier.

Andrew Dickinson: Nonetheless, we expect a strong year overall for our HIV business and continued growth in the subsequent quarters. Looking beyond Q1, we expect the impact of the Truvada and E-Tripla LOEs to be largely behind us starting in Q2, and we look forward to accelerating growth in our HIV business during the remainder of the year. For the full year 2022, we expect VEC-LURI sales of approximately $2 billion.

Unless we expect a strong year overall for our HIV business and continued growth in the subsequent quarters.

Looking beyond Q1, we expect the impact of the Truvada and Triple Eloise will be largely behind us starting in Q2, and we look forward to accelerating growth in our HIV business during the remainder of the year.

For the full year 2022, we expect <unk> sales of approximately two 2 billion.

Andrew Dickinson: This assumes, as I previously indicated, that Omicron will represent the only major surge for the year, with VEC-LURI revenue heavily weighted in the first quarter. That said, the pandemic continues to be dynamic, and we will update you on our VEC-LURI expectations on a quarterly basis, consistent with our recent practice. Moving to the rest of the P&L, we expect our non-gap product gross margin to be approximately 85 to 86%, consistent with our historic guidance and allowing for the 3% royalty associated with the legal status.

This assumes as I previously indicated that Amazon will represent the only major third for the year with veterinary revenue heavily weighted in the first quarter.

That said the pandemic continues to be that continues to be dynamic and we will update you on a regulatory expectations on a quarterly basis consistent with our recent practice.

Moving to the rest of the P&L, we expect our non-GAAP product gross margin to be approximately 85% to 86% consistent with our historic guidance and allowing for the 3% royalty associated with the legal settlement.

Andrew Dickinson: [inaudible] For non-gap operating expenses, we expect R&D to decline or decrease by a mid-single-digit percentage compared to 2021 levels. This decline is driven by the net 625 million-dollar charge related to the Arches opt-in in the fourth quarter of 2021. Excluding this, we expect full-year R&D expense to increase by a mid-to-high-single-digit percentage compared to 2021 levels. We expect SG&A expense to be approximately flat on a dollar basis compared to 2021. Our non-GAAP effective tax rate is expected to be approximately 20% this year.

non-GAAP operating expenses, we expect R&D to decline or to decrease by a mid single digit percentage compared to 2021 levels.

This decline is driven by the net $625 million charge related to the ARCUS opt in in the fourth quarter of 2021.

Excluding this we expect full year R&D expense to increase by mid to high single digit percentage compared to 2021 levels.

We expect SG&A expense to be approximately flat on a dollar basis compared to 2021 or.

Our non-GAAP effective tax rate is expected to be approximately 20% this year.

Andrew Dickinson: Finally, we expect our non-GAAP diluted EPS to be between $6.20 and $6.70 for the full year, and GAAP diluted EPS to be between $4.70 and $5.20. As for capital allocation, our priorities have not changed. We continue to invest in our business while, at the same time, we returned over $4 billion in 2021 to our shareholders through dividends and share repurchase. In addition, we repaid $4.7 billion of debt in 2021. For 2022, we plan to repay $1.5 billion of debt, of which we repaid $500 million this morning. With that, I would invite the operator to begin the Q&A. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the back key.

Finally, we expect our non-GAAP diluted EPS to be between $6 26.

$6 70 for the full year and GAAP diluted EPS to be between $4 70, and $5 20.

On capital allocation, our priorities have not changed we continue to invest in our business. While at the same time, we returned over $4 billion in 2021 to our shareholders through dividends and share repurchases in.

In addition, we repaid $4 7 billion of debt in 2021 for 2022, we plan to repay one $1 5 billion of debt of which we repaid $500 million. This morning.

With that I will invite the operator to begin the Q&A. Thank you.

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the button pain. We ask that you. Please limit yourself to one question and if you have a follow up you may re enter the queue.

Please standby, while we compile the Q&A roster.

Our first question comes from the line of Geoff Meacham from Bank of America. Your line is now open.

Operator: We ask that you please limit yourself to one question, and if you have a follow-up, you may re-enter the queue. Please stand by when we compile the Q&A roster. Thank you very much. Our first question comes from the line of Geoff Meacham from Bank of America. Your line is now open.

Okay, Great Hey, guys. Good afternoon, and thanks for the question.

Geoff Meacham: Okay, great. Hey guys, good afternoon. Thanks for the question. Dan or Andy, maybe a higher-level strategic question.

Dan or Andy maybe a higher level strategic question I wanted to ask about your comment regarding long term oncology sales.

Daniel O'Day: I wanted to ask about your comment regarding long-term oncology sales. The question is, are you comfortable with the aggregate assets in the portfolio? Do you think you'll need to be more aggressive on BD either to drive more near-term growth or look longer term to have higher impact assets? Thank you very much.

The question is are you comfortable with the aggregate assets in the portfolio do you think youll need to be more aggressive on BD.

Either to drive more near term growth.

Or looking longer term.

Higher impact assets. Thank you very much.

Daniel O'Day: Thanks, Geoff. Thanks for the question and for teaming up. I'll start and then hand it over to Andy.

Thanks, Jeff Thanks for the question of clean it up I'll start and then hand it over to Andy So.

Yes.

<unk>.

The guide that we gave at Jpmorgan was that we are confident in our ability to.

To grow and to also have oncology by 2030 be at least a third of our overall revenue on top of a.

Solid.

I V.

And Barology business overall I think the answer the question. Jeff is we believe we have everything in house to be able to fulfill on that commitment today I mean, the number of options that we have with <unk> with <unk> with the ARCUS assets and with cell therapy.

Daniel O'Day: So, yeah, I mean, the guide that we gave at J.P. Morgan was that we are confident in our ability to grow and to also have oncology by 2030 be at least a third of our overall revenue on top of a solid HIV business and virology business overall. I think the answer to the question, Geoff, is that we believe we have everything in-house to be able to fulfill that commitment today. I mean, the number of options that we have with Tredelvi, with Magrolumab, with the Arcus assets, and with cell therapy from an oncology base provides tremendous opportunities for us to look alone and in combination at that portfolio in the coming years.

Oncology based provides tremendous opportunity for us to look alone and in combination of that portfolio.

In the coming years and that specifically.

Daniel O'Day: And that specifically leads to the more than 30 clinical trials we have ongoing right now in our oncology portfolio and our guideline that this year we'll start at least another 20 in the oncology space, so really that's the arsenal behind our commitment and our growth.

Leads to the more than 30 clinical trials, we have ongoing right now on oncology portfolio and our guide that this year, we will start at least another 20.

Oncology space so.

It really does that.

The armamentarium behind our commitment and our growth of course will continue to be opportunistic around business development and look for supplemental options out there that can complement this portfolio is a course of normal business is there any healthy company should.

Andrew Dickinson: Of course, we'll continue to be opportunistic around business development and look for supplemental options out there that can complement this portfolio as a course of normal business, as any healthy company should. Having said that, we really do have enough in-house to be able to fulfill that commitment. So, with that, Andy, I may have stolen all your thunder, but I'm sure you'll have some additional perspectives. Please.

Having said that we really do have enough in house to be able to fulfill upon that commitment so that Andy.

Still in all your Thunder, but im sure Youll.

So additional perspectives, Jeff. Thank you for the question.

Andrew Dickinson: Yes. Jeff, thank you for the question. I think it's an important question, especially in the context of the Magrolumab clinical hold that may be underpinning the question specifically, but the answer is relatively simple.

It's an important question, especially in the context of the Mcgraw clinical hold that.

Maybe underpinning the question specifically, but the answer is relatively simple we have a very strong set of assets already the guidance that we provided of JP Morgan does not actually include all of the assets are all the indications for all the assets. So theres a lot of ways for us to get there we have complete confidence in where we're going and we don't expect to change our BD strategy as a result of any of the recent <unk>.

Andrew Dickinson: We have a very strong set of assets already. The guidance that we provided at J.P. Morgan does not actually include all of the assets or all the indications for all of the assets, so there's a lot of ways for us to get there. We have complete confidence in where we're going, and we don't expect to change our BD strategy as a result of any of the recent developments.

<unk>, we're actually really excited about where we are.

Andrew Dickinson: We're actually really excited about where we are, and there's a lot of upside to that if other assets, whether it's some of the earlier Arcus assets or the Tizona or Pioneer assets, as examples, provide additional options for patients. So when you talk about high-impact assets, I would just summarize by saying that we already think that we have a great portfolio of high-impact assets in oncology. We're incredibly pleased with what we've put together, and nothing that's happened recently has changed that in any way. So thanks for the question. Thank you. Thank you. Thank you. Our next question comes from the line of Mohit Bansal from Wells Fargo. Your line is now open.

And there is a lot of upside to that if other assets, whether it's some of the earlier ARCUS assets or the designer or a pioneer.

As examples.

Provide additional options for patients so when you're talking about high impact assets I would just summarize by saying we already think we have a great portfolio of high impact assets in oncology, we're incredibly pleased with what we've put together and nothing that's happened recently is change that in any way. So thanks for the question.

Thanks, Craig.

Lauren.

Our next question comes from the line of Mohit Bansal from Wells Fargo. Your line is now open.

Hey, Thanks for taking my question and good afternoon.

Mohit Bansal: Great, thanks for taking my question and good afternoon. Maybe I have a question for Merdad. So in the light of new data that are emerging in HR positive and HER2 negative breast cancer, do you have any updated thoughts on how to think about overall survival in the treatment and control arm for Propex O2, vis-a-vis the expectation or the assumptions in clinical trials, which are, I think, if I'm not mistaken, 12 months for the control and 16 and a half months for the treatment? So how should we think about OS?

Maybe a question for Mike.

So in the light of new data that are emerging in HR positive <unk> negative breast cancer.

Do you have any updated thoughts on how to think about overall survival in the <unk>.

<unk> and control arms for products with two vis vis.

The expectation.

<unk> and <unk> I think if I'm not mistaken 12 months for the control and 16 in Hoffman for the treatment.

How should we think about the Wes thank.

Thank you thank.

Merdad Parsey: Thank you. Thanks, Mohit. Yeah, directly over to you, Merdad. Yeah, thanks, Mohit. It's a great question, and I think, as I mentioned in my call, I think we're excited that we're going to be able to share the first interim analysis from the OS as well when we do the readout here for the PFS. So, I do think we'll look at both at the same time. You're absolutely right that there are developments in the positive HR space.

Thanks Maria directly over to you, yes, thanks, Mike It's a great question and I think as I mentioned in my call. I think we're excited that we're going to be able to share. The first interim analysis from the OS as well when we do the read out here for the PFS. So I do think we will look at both at the same time.

You're absolutely right that there are developments in the HR positive space, but I continue to believe and I think.

Merdad Parsey: But I continue to believe, and I think, you know, the impact on both PFS, on PFS in particular here, but also OS, continues to be, I think if we see something in the ballpark of what you just described, we're confident that that remains incredibly clinically relevant for people suffering with HR positive and HER2 negative. It is, as you state, an increasingly competitive area, but we do think that it remains a key milestone for patients if we can achieve it. Thank you. Our next question comes from the line of Ori Casimbo from J.P. Morgan. Your line is now open.

I think that the.

Impact on both PFS on PFS in particular, but also.

Continues to be I think if we see something in the ballpark of what you. Just described we are confident that that remains incredibly clinically relevant for <unk>.

People suffering with with HR positive <unk> negative.

It is as you state and increasingly competitive.

Area, but we do think that that remains a key milestone for for patients. If we can achieve that.

Thank you.

Our next question comes from the line of Cory <unk>.

From Jpmorgan. Your line is now open.

Operator: Hey, good afternoon, guys. Thank you for taking my question. I wanted to follow up as well on the Tropics02 study.

Hey, good afternoon, guys. Thank you for taking my question I wanted to follow up as well on the on the tropics <unk> study and maybe <unk> can you talk about how you see the potential significance of this convergence of events that you alluded to when thinking about both progression free survival and overall survival did you see any.

Merdad Parsey: And maybe, Merdad, can you talk about how you see the potential significance of this convergence of events that you alluded to when thinking about both progression-free survival and overall survival? Did you see any implications from this? Or is this kind of moving along the lines as you would have expected it to?

<unk> from this or is this kind of <unk>.

Moving along the lines as you would've expected it too thank you.

Merdad Parsey: Thank you. Yeah, great question, and thanks for asking it. I think I'm very reassured.

Yes, great question and thanks for asking it.

I think I am very reassured I would not read anything.

Into this other than the fact that we've been as you can imagine keeping track of the PFS events and the OS events all along.

Merdad Parsey: I would not read anything into this, you know, other than the fact that we've been, as you can imagine, keeping track of the PFS events and the OS events all along. And, you know, we've now gotten to the point where those OS events have occurred in a timeframe that allows us to look at both of these events at the same time. I don't think it really says anything about, I think what you're getting at is, does it have any implications for the underlying, you know, positive or negative or anything like that?

And.

We've now gotten to the point where those events.

Have occurred.

In a timeframe that allows us to look at both of these events at the same time I don't think it really says anything about I think what youre getting at is does it have any implications for the underlying.

Positive or negative or anything like that and I really I really don't think there's any way to interpret that right now it would be pure speculation to think that there is some.

Merdad Parsey: And I really, I really don't think there's any way to interpret that right now to be pure speculation to think that there's some, you know, some underlying driver of bringing those endpoints together. And actually, it's not that unexpected.

Some underlying driver of bringing those endpoints together and actually it is not that unexpected it's a little bit closer in than we thought it would be but not not not by that much. So I wouldn't read too much into it I am just excited we'll be able to do it it will be a more robust look and I think as I've said before we.

Merdad Parsey: It's a little bit closer in than we thought it would be, but not by that much. So I wouldn't read too much into it. I'm just excited we'll be able to do it. It'll be a more robust look. And I think, as I've said before, we think the regulators are going to want to see those robust looks at the OS to help them with the, you know, sort of, in a sense, supporting the PFS endpoint.

We think the regulators are going to want to see those robust looks at the Pos to help them.

With.

Sort of in a sense supporting the PFS endpoint.

Thanks, Corey can we have the next question please.

Merdad Parsey: Thanks, Corey. Can we have the next question, please? Our next question comes from the line of Brian Abrahams from RBC Capital Markets. Your line is now open. Hey guys, thanks so much for taking my question. I wanted to better understand the potential signals from Macrolumab.

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

Your line is now open.

Hey, guys. Thanks, so much for taking my question I wanted to better understand the potential signals from <unk>. I think you guys have said that you havent observed any clear trend curious where's the disconnect versus what the FDA an investigator concerns are here.

Brian Abrahams: I think you guys have said that you haven't observed any clear AE trend. I'm curious, where's the disconnect versus what the FDA and investigator concerns are here? And maybe talk a little bit about the potential path to resolution, what additional safety data would be needed, and your level of confidence that you will reach a resolution. Thanks.

And maybe talk a little bit about the potential path to resolution what additional safety data would be needed in your level of confidence you will reach a resolution.

That's great. Thanks, Brian Thanks, Cory, Yes, I think.

Merdad Parsey: Thanks, Brian. Thanks, Corey. Yeah, I think so.

So.

Merdad Parsey: Look, I think the way to think about it is that there have been a couple of events where the agency wants to make sure that they have a chance to look at the overall safety profile. I remain blinded to the safety data, so what is going on is we are gathering the safety data, and we're going to share it with the FDA and with the Data Monitoring Committee. I can tell you that we feel that these are temporary challenges right now, and we're going to work through resolving them as quickly as possible.

Look I think I think the way to think about it is.

There've been a couple of events that the agency wants to make sure that they have a chance to look at the overall.

Overall safety profile.

I remain blinded to the tune of safety data. So what is going on as we are.

Gathering the safety data and we're going to share it with the FDA and with the.

The data monitoring committee.

I can tell you that.

We feel that these are temporary challenges right now and we're going to work through resolving it as quickly as possible.

I don't think these challenges really shake our confidence for for the portfolio overall and our overall strategy Hasnt changed.

Merdad Parsey: I don't think these challenges really shake our confidence in the portfolio overall, and our overall strategy hasn't changed. We're really committed to the MAGRA development program, and we think that it really continues to have the potential to address an important unmet medical need. The other thing I'd add is that these are generally pretty sick patients, and with that underlying illness, I think it's appropriate to be cautious and make sure that we're striking the right balance as we go forward.

Committed to the macro development program and we think that it really continues to have the potential to really address.

An important unmet medical need.

The other thing I would add is remember these are very generally pretty sick patients and with that underlying illness. I think it's appropriate to be cautious and make sure that we are striking the right balance as we go forward, but we will we'll work through it by looking at the overall.

Merdad Parsey: But we'll work through it by looking at the overall safety profile, Brian, and make sure that we are able to resolve those issues with the FDA. And, Brian, we'll keep you informed as that evolves. We have, obviously, a lot of patients on Megrolomab that continue to be served by Megrolomab, so we have a sense of urgency in working with the agency around that. Thank you very much, Brian. We have the next question, please.

Safety.

The overall safety profile, Brian and make sure that we.

Are able to resolve those issues with the FDA.

And Brian will keep you informed as that evolves, we have obviously a lot of patients on <unk> to continue to be served by <unk>. So we have a sense of urgency and working with the agency around.

Thank you very much Brian next question. Please.

Thank you. Our next question comes from the line of <unk> Richter from Goldman Sachs. Your line is now open.

Merdad Parsey: Thank you very much, thank you very much. Thank you, our next question comes from the line of Salveen Richter from Goldman Sachs. Your line is now open. Good afternoon, thanks for taking my question. You referred to the Arcus portfolio.

Good afternoon. Thanks for taking my question you referred to the ARCUS portfolio can you just comment on what you're most excited about outside of ticket and when you might start the triplet study.

Sure Doug why don't you start on that sure.

Salveen Richter: Can you just comment on what you're most excited about outside of Tidgett and when you might start the triplets? Sure, Merdad. Why don't you start? Sure, you know, I think in addition to the TIGID asset, as you know, the adenosine portfolio, the two molecules, the two inhibitors of adenosine, both in terms of the synthesis inhibitors, CD73, as well as the receptor blocker, are really interesting to us. They're early programs, but we think that there is a real potential for those assets to provide significant upside to treatment, both in terms of where they are in lung cancer, where we think there is some, the trial that's ongoing that is looking at the addition of adenosine inhibition to TIGID plus PD-1, as well as in some of the indications that ARCIS is evaluating with monotherapy, in particular pancreatic cancer.

<unk>.

In addition to the tissue asset as you know the the.

Dennis in portfolio, if you will the two molecules.

Inhibitors identifying both in terms of the synthesis inhibitor <unk> hundred 73, as well as the receptor blocker.

Really interesting to us their early programs, but we think that there is a real potential for those assets to provide.

Significant upside to two treatment both in terms of where.

In lung cancer, where we think.

There is some.

The trial, that's ongoing that is looking at the addition of.

Adenosine inhibition to <unk>, plus PD, one as well as in some of the indications that are considered evaluating with monotherapy in particular pancreatic cancer.

Salveen Richter: So, I think, for us, there are a number of opportunities there, and the broad potential of adenosine inhibitors to add on to immuno-oncology in general, and TGIC plus PD-1 in particular, really strikes us as a really great opportunity that, hopefully, as the data mature, we'll be able to share more and really underpin the optimism we have around one of those programs. And I think there was a question around when to start the, Oh, and then the triplet study. Yeah, but we haven't announced that yet. We need to work through some details. Thanks for reminding me, Dan.

I think for US there are a number of opportunities there and the potential the broad potential of adenosine inhibitors to add onto immuno oncology in general and <unk> plus PD one in particular.

Really strike us as a really great opportunity that hopefully as the data mature we will we will be able to share more in really.

Underpinned.

The optimism we have around where those programs are headed.

And I think there was a question around when to start.

And then the triplet study yes.

We haven't announced that yet we need to work through.

Some details thanks for reminding me, Dan we're working through some.

Merdad Parsey: We're working through some approaches. Really, the question here for us is how to go from the doublet, where we're really looking at a tiget inhibitor being an unapproved agent, right? And then potentially bringing in a second unapproved agent.

Approach really the question here for US is how to go from.

The the doublet, where we're really looking at tissue inhibitor being in.

An unapproved agent right.

And then potentially bringing in a second.

Unapproved agent so we have to work through.

The regulatory complications of how we have to sequence and stage those studies to allow us to assess the contribution of components such that we can move forward aggressively. So we're working really closely with our adenosine colleagues are identifying colleagues are arc as colleagues and.

Merdad Parsey: So we have to work through, in a sense, the regulatory complications of how we have to sequence and stage those studies to allow us to assess the contribution of components such that we can move forward aggressively. So, we're working really closely with our Adenosine colleagues, our ARCIS colleagues, and we'll work through the regulatory pathways to make sure that we can get to robust phase 3 trials with those. So, as we do so, we'll certainly share the timing and the pathways.

We'll work through the regulatory pathways to make sure that we can get to robust phase phase III trials with those so as.

As we do so we'll certainly share that.

Timing in the pathway.

Merdad Parsey: And Salveen, the only thing I'd add on top of Merdad's very eloquent response is the potential to combine this attractive portfolio from Arcus with other medicines that we have within Gilead, including Tredelvi and possibly Migrolumab and others. So this combination of having access to a PD-1, two-digit compound, two adenosines combined with Tredelvi provides a rich opportunity to look at rational-based combinations.

And so being the only thing I'd add on top of that it's very eloquent response has the potential to combined.

This attractive portfolio for Marcus with other medicines that we have within gilead, including <unk>, and possibly Mcgraw amount and others. So the combination of having access to a PD one to tissue compounds to identifying combined with <unk> provides a rich opportunity to look at rational dose combinations and we will be getting more.

Daniel O'Day: And we'll be getting more into that as we do a deeper dive into oncology as a starting point in April, and then obviously throughout the year, we'll continue to update you on that. And it's one of the major reasons why opting in early was important to us because we can work really fluidly now across a very rich portfolio. And with the additional expertise and colleagues from Arcus, it really expands all of our potential in clinical science and beyond. Thanks, Salveen, for the question.

And to that as we do a deeper dive in oncology as a starting point in April and then obviously throughout the year, we'll continue to update you on that and it's one of the major reasons why opting in early was important to us because we can work really fluidly now across a very rich portfolio.

And with the additional expertise and colleagues from ARCUS.

Really expands all of our potential in clinical science and beyond.

Thanks <unk> for the question can we have the next question. Please.

Our next question comes from the line of Michael Yee from Jefferies. Your line is now open.

Operator: Can we have the next question, please? Our next question comes from the line of Michael Yee from Jeffreys. Your line is now open.

Hey, thanks.

Michael Yee: Hey, thanks. Thanks for the question. I appreciate it.

Thanks for the question appreciate it may be back to more debt on <unk> appreciating that I know theres a lot of focus on this interim OS.

Merdad Parsey: Maybe back to Merdad on Tridelvy, appreciating that, you know, I know there's a lot of focus on this interim OS. I would love to give you the opportunity to perhaps, you know, frame expectations at an interim. You know, interims have different connotations, and there are different interims at different percent of events that have accrued. So could you just explain what percent of events this interim is based on? Do you actually expect to hit that SIG, or do you expect a trend for a few months?

Love to give you the opportunity to perhaps frame expectations at an interim.

Interims have different conversations and theres different norms, a different percent of events that have accrued. So could you just explain what percent of events. This interim is based on <unk>, we expect to hit Stat. Sig. We're just expecting a trend of a few months, maybe just talk to that a bit because I think theres different implications of Justin Andrew. Thank you yeah. Thanks, Mike.

Merdad Parsey: Maybe just talk about that a bit because I think there are different implications for just an interim. Thank you. Thanks, Michael. And maybe just a suggestion as you answer Michael's specific question, it might be helpful for the whole audience to hear again your kind of overall view. Michael, it's a great question, and I think, thank you for asking it. So as a reminder, you know, I think from a PFS standpoint, the primary endpoint of the study, we believe we're really well-powered to detect a difference there.

And maybe just a suggestion as you answered Michael specific question it might be helpful for the whole audience to hear again kind of your overall view.

Of.

This potential success, yes.

Yes, Michael that's a great question and I think thank you for asking it so.

As a reminder, I think.

From a PFS standpoint, the primary endpoint of this study we believe we're really well powered.

To detect a difference there.

Merdad Parsey: And as I'll remind folks, we did redesign this study a year ago in order to power the study adequately for OS as well. I would, I think, as excited as I am that we will be able to report out that first interim analysis, Michael, you're absolutely right on that. I would not expect statistical significance at this first interim analysis because it is relatively early in the timeframe that we're seeing.

And as I'll remind folks we did redesign this study a year ago in order to power.

<unk> adequately for OS as well.

I would.

I think as excited as I am that we that that we will be able to report out that first interim analysis, Michael Youre, absolutely right on that.

I would not expect statistical significance at this first interim.

It is relatively early.

And the and.

The timeframe.

That we're seeing so.

Merdad Parsey: So, my expectation is that, again, pending a positive outcome, that we are well-powered to see a PFS improvement at a statistically significant level, and the OS will be supportive data at that point that will give us directionality as to where we're headed. And then, you know, hopefully, subsequent to that, as the events accumulate, we'll see where we're headed with OS and down the road. It's a great

My expectation is that.

Again pending a positive outcome that we are well powered to see.

PFS improvement it is statistically significant level and the OS will be supportive data at that point that will give us directionality as to where we're headed and then.

Hopefully subsequent to that as the events accrue.

We'll see where we're headed with OS.

Down the road, it's a great question.

Thanks, Michael.

Operator: Thanks, Michael. Can we have the next question? Our next question comes from the line of Ronnie Gao from Bernstein. Your line is now open.

Next question please.

Our next question comes from the line of Ronny Gal from Bernstein. Your line is now open.

Ronnie Gao: Good afternoon, and thank you for taking my question. Switching over to talk a little bit about Yaskarta, can you tell us if there's already been impact on the use of Yaskarta in second line, or is it still ahead of us? And you've mentioned you're increasing your capacity by 50%. Are you currently capacity constrained or demand constrained?

Good afternoon, and thank you for taking my question switching over to talk a lot about it yet Carla.

Can you tell us if there is already impact on the use of your Scott second line or is this still ahead of US and you had mentioned you're increasing your passionate about 50% currently capacity constrained or demand constraints, essentially where all of that demand be used if it comes to life.

Yeah. Thanks Ronny.

Daniel O'Day: Essentially, will all that demand be used if it comes online? Yeah, thanks, Ronnie. And as I turn it over to Christie, let me just say how, you know, how many patients we'll be able to impact with cell therapy in 2021. And that being just the beginning of, I think, our promise for the future. We certainly invested in the manufacturing capacity to anticipate demand and success in the second line. And Christie can go into the details with you. Christie, over to you.

As I turn it over to Christine Let me just say how.

No.

How many patients we've been able to.

Impact with cell therapy in 2021 and that being just the beginning of I think of our promise for the future. We certainly invested in the manufacturing capacity to anticipate demand and success in the second line and Kristie can go into the details with you Christy over to you.

Thanks, Dan Thanks for the question, Yes, we're very excited about not only the second line, which is the most important to help the most patients but the continued successful third line plus with the five year data that was presented at Ash, where we are for your top 43% of postal still alive and at 44% of patients still alive or four years.

Christy Schull: Thanks, Dan. Thanks for the question. Yeah, we're very excited about not only the second line, which is the most important to help the most patients, but the continued success of the third line plus the five-year data that was presented at Ash, where at year four, you saw 43% of patients still alive, and at 44% of patients still alive at four years, and 43% at five years, which I think you heard your dad say.

3%.

Five years, which I think you heard me today I'd say, they're both on those as well as new indications coming out we're really seeing an increase in demand or capacity.

Christy Schull: So based on those, as well as new indications coming out, we're really seeing an increase in demand. Our capacity is well positioned. You know, we have the El Segundo Manufacturing Site here in California. Amsterdam was approved during COVID and was up to its capacity by the end of last year.

We're well positioned we have the also Glendale manufacturing site here in California, Amsterdam with approved during Covid and.

With up to its capacity by the end of last year and now we have the Merrill Lynch site, which all will be going online in the first half of this year.

Youll see our automation as well so not only are increasing capacity, but also the ability to reduce costs. So things are coming along nicely in terms of our ability to deliver.

No we still have that reliability of 97% success, when we give the cells back which is so critically important propulsion. So.

A capacity issue.

Transparency a couple of issues last year, where we had a scheduling issue where physicians were asking for the exact same slot all at the same Thailand.

Quickly address that.

And no longer have that concern so.

We're doing well in preparing for hopefully what we'll see is helping a lot more close in say a live a lot longer.

Thanks, so much Christine overall, Ronny, we're expecting about a 50% increase in capacity over the course of 2022 so.

Christy Schull: And now we have the Maryland site, which will be online in the first half of this year, where you'll see our automation as well, so not only an increase in capacity but also the ability to reduce costs. So things are coming along. We still have that reliability of 97% success when we give ourselves back, which is so critically important to patients. So not a capacity issue, you know; we had a transparency, a couple of issues last year where we had a scheduling issue where physicians were asking for the exact same spot all at the same time, and we quickly addressed that. And I no longer have that concern.

Christy Schull: So we're doing well and preparing for, hopefully, what we'll see is helping a lot more patients stay alive a lot longer. Thanks so much, Christy. And overall, Ronnie, we're expecting about a 50% increase in capacity over the course of 2022, continued investment there.

Continued investment there. Thanks, Ronnie can we have the next question. Please.

<unk>.

Daniel O'Day: Can we have the next question, please? Our next question comes from the line of Colin Bristow from UBS. Your line is now open.

Our next question comes from the line of Colin Bristow from UBS. Your line is now open.

Hey, good afternoon, and thanks for taking the question.

Operator: Good afternoon, and thanks for taking the question. On Gronomad, maybe could you explain why the multiple myeloma and DL-BCL trials are also on hold, given they're not in combination with AZER? And then, just somewhat related to that, the $1.50 in acquisition-related expenses in the 22 guide, is there any component of that that's related to the 47 acquisition?

Great.

Could you explain why the multiple myeloma and <unk>.

Bcl trial, but also on hold given that not in combination with Asia, and then just somewhat related to that.

The $1 50 and acquisition related expenses in the 'twenty. Two guide is there any component of that that's related to the 47 acquisition. Thanks.

Great.

Colin Bristow: Thanks. Great. So we'll have Andy answer the second question, but maybe you want to touch base on the first one, Merdad, also telling us about the stage of those two trials.

Andy The second maybe you wanted to touch base on the first.

Also telling about the stage of those two trials.

Yes, it's really important.

Merdad Parsey: Yeah, it's really important to, I think this may not have been entirely clear. First of all, I think, look, I think whenever there's a safety question, the agency is going to err on the side of being cautious. And so we'll work through with them on how to go forward. And I agree that in those studies, we are not combining with azacitidine.

I think this may have.

Not been entirely clear.

First of all I think look I think whenever there is a safety question. The agency is going to err on the side of being cautious and so we'll work through with them.

On how to go forward and I agree and those studies, we're not combining with Asus <unk>. So again I think as we as we share the data and the analysis with the agency hopefully we can come to resolution sooner than later.

Merdad Parsey: So again, I think as we share the data and the analysis with the agency, hopefully, we can come to a resolution sooner than later. And it's important to note that for the multiple myeloma study, we actually hadn't really started enrolling patients at that point, so I think that was one consideration. And by contrast, for the DLBCL study, that study is completely enrolled.

Yes.

And it's important that.

Note that for the the <unk>.

Multiple myeloma study, we actually hadn't really started enrolling patients at that point. So I think that was one consideration and by contrast for the <unk> study that study is completely enrolled.

The partial hold there actually doesn't have much of a practical impact on that study because we're going to continue dosing the patients who are already enrolled in that study so.

Merdad Parsey: So the partial hold there actually doesn't have much of a practical impact on that study because we're going to continue dosing the patients who are already enrolled in that study. So, you know, I think it's important to remember that the way it works is, maybe the context here is the holds are placed on an IND, not on a study by study basis generally. So this was a hold on the IND.

I think remember that where the way it works with maybe the context here. The holds are placed on an indie not on a study by study basis generally. So this was a hold to the IMD and so that's sort of the context to think about it.

Merdad Parsey: And so that's sort of the context to think about it. And I'll hand it off to Andy to answer the second part of the question. Sure. Hi Colin.

After Andy to answer the second part of the question sure Hi, Collyn I am not sure that I fully understood. The question, but what I can tell you is none of the none of the update that we provided in terms of the one time fourth quarter expenses, nor none of our 2022 guidance has anything to do with 47% expenses. So.

Andrew Dickinson: I'm not sure that I fully understood the question, but what I can tell you is none of the updates that we provided in terms of the one-time fourth quarter expenses, none of our 2022 guidance has anything to do with 47 expenses. So you and I can maybe talk separately to understand what your question is specifically, but there's nothing related to 47 or the 47 acquisition that was either part of our fourth quarter update, year-end update, or part of the 2022 guide specifically. Thank you. Thanks, Colin.

You and I can maybe talk separately to understand what your question is specifically, but theres nothing related to 47% 47 acquisition that was either part of our fourth quarter update year end update or part of the 2022 guidance specifically.

Thank you thanks, Kevin happy to take that up separately too. So let's go to the next question. Please.

Our next question comes from the line of hard Taj Singh from Oppenheimer. Your line is now open.

Operator: I'm happy to take that up separately too. So let's go to the next question, please. Our next question comes from the line of Hartaj Singh from Oppenheimer. Your line is now open.

Hartaj Singh: Hey, thank you everyone. Thanks for the question. This is just a question about Vic Laurier.

Hey, thanks, everyone. Thanks for the question.

Just a question on the glory youre, starting to get a pretty consistent franchise there.

Johanna Mercier: You know, you're starting to get a pretty consistent franchise there. I mean, unfortunately, COVID-19 is still out there. You know, various experts have indicated, even some of the companies we cover, we're going from a pandemic to an endemic kind of state this year into next year. How do you think of Vic Laurier, you know, going forward?

Unfortunately, COVID-19 is still out there.

Various experts have indicated and even some of the companies. We cover we're going from a pandemic trial endemic kind of state over this year into next year, how do we how do you think of the glory going forward I know, it's difficult to give guidance there, but you've got a year and a half worth of data underneath your belt are you thinking of hospitalizations going forward.

Johanna Mercier: I know it's difficult to get guidance there, but you've got a year and a half worth of data under your belt. How are you thinking of hospitalizations going forward? You know, whether that's through breakthrough infections, you know, or do you see as unvaccinated individuals get less and less, that hospitalizations will concomitantly decrease? Any thoughts there?

Through breakthrough infections or do you see as undocumented individuals get less and less.

Hospitalization won't concomitantly decrease any thoughts there and then assuming the oral program gets approved how do you see.

Johanna Mercier: And then, assuming the oral program gets approved, how do you see, you know, remdesivir IV and then the oral option working together going forward? And again, thanks for the questions and a really nice, thanks, Hratash. So, I think Johanna can start with some of the epidemic, and then Merdad could also comment a little bit on the forward portfolio. But please, Johanna, what do you think?

<unk> IV and then the oral option working together going forward and again, thanks for the questions in the next quarter.

So.

I think Joanna can start with some of the pandemic.

Endemic and then.

So that could also comment a little bit on the forward portfolio, but please thanks.

Johanna Mercier: Thanks, Hratash, for the question. Basically, what we've seen since the very beginning is how the glory sales truly track to hospitalizations. And we've seen that most recently, again, with the Omicron surge. What we did see, as well, is the fact that despite the fact that Omicron seemed to have a maybe less severe impact, unfortunately, the number of cases were much greater, and, therefore, just the pure absolute numbers of hospitalizations went up.

Thanks very much for the question.

Basically what we've seen since the very beginning is how.

<unk> sales truly track to the hospitalizations and we've seen that most recently again with the <unk> surge.

What we did see as well is the fact that.

Despite the fact that <unk> too.

You may be less severe impact unfortunately, the number of cases, where much greater and therefore, just the pure absolute numbers of hospitalizations went up.

Johanna Mercier: And so we've tracked every single time pretty much in line parallel to the hospitalization rates, and we assume that will continue. We do think the hospitalizations will get impacted by some of the oral compounds, even some of the outpatient use of Viclory, but also neutralizing antibodies, as well as oral treatments, as well, like the PI from Pfizer.

And so we've tracked every single time pretty much in line parallel to the hospitalization rate for me. We assume that will continue we do think the hospitalizations will get impacted by some of the oral compounds, even some of the outpatient use of that glory, but also neutralizing antibodies as well as the oral treatments as well like the <unk>.

From Pfizer and so we do think that will decrease hospitalizations over time. The one thing we had assumed maybe about a year ago as we really thought the vaccination rates would continue to rise and they didn't.

Johanna Mercier: And so we do think that'll decrease hospitalizations over time. The one thing we had assumed maybe about a year ago is that we really thought the vaccination rates would continue to rise, and they didn't. They basically stabilized at around the 60-65% rate. And, of course, there are variances across the country.

They basically stabilized at around the 60% to 65% rate and of course, there are variances across the country. So what we've seen is the use of different treatments as well as the vaccinations. The vaccination rates are really dictating a little bit.

Johanna Mercier: So what we've seen is the use of different treatments, as well as the vaccination rates, are really dictating a little bit of the hospitalizations and, therefore, the Viclory usage. And yet again, in the December and January timeframe, we've really seen Viclory play a critical role here for these hospitalizations, also having to do with the fact that many of the other previous agents that were on the market were no longer effective against the Omicron variant. And We haven't seen any of that. We've seen very strong efficacy with Viclory, which has also helped.

Kind of a hospitalization and therefore that that Clara usage and yet again in the December January timeframe, we've really seen declaring play a critical role here for these hospitalization also having to do with the fact that many of the other previous agents that were on the market we're no longer.

We no longer.

Effective against the on the commentary yet and we haven't seen any of that we've seen very strong efficacy with that quarry, which is also help that I think most recently the outpatient data.

Johanna Mercier: I think most recently, the outpatient data that's come out in addition to the indication really plays a critical role when there are surges and hospitals are over capacity so that they really can look at the outpatient setting with Viclory. And we think that'll just kind of play hand in hand. And I would propose, as I turn it over to Merdad, to address the oral piece of the puzzle. I actually think you need both. I think you need an oral setting.

Got to come out in addition to the indication really plays a critical role when Theyre searches and hospitals are overcapacity. So that they really can look at outpatient setting with declaration.

We think that will just kind of play hand in hand, and I would propose as I turn it over to <unk> to address the <unk> piece of the puzzle I actually think you need both I think you need the oral setting some mark Moore.

Merdad Parsey: So more players in the oral setting are critical. And you still need hospitalizations because, unfortunately, as this becomes, if it does become endemic, I do think you'll see a steady rate of hospitalizations as we go through. And that's where Viclory plays a critical role. Merdad?

More players in the <unk> setting is critical and you still need hospitalizations because unfortunately.

As this because if it does become endemic I do think Youll see a steady rate of hospitalizations as we go through and Thats perfect. Clearly plays a critical role radar, yes, thanks, and I guess I'd make two points. The first is.

Merdad Parsey: Yeah, thanks. And I guess I'd make two points. The first is that it is very early days with the oral program. And so I would keep that in mind. We just started phase one, so a lot of things can happen. And so I would just keep that in mind. Obviously, if things go well, we'll move as aggressively as possible. And I agree with Johanna. I think that there will always be a role for both oral and IV treatments.

It is very early days with the oil program and so I would I would keep that in mind. We just started phase one so a lot of things can happen and so I would just keep that in mind.

Obviously, if things go well, we will move as aggressively as aggressively as possible and I agree with Joanna I think that there will always be a role.

Merdad Parsey: There will be, you know, what we're seeing now, I think, in terms of how folks are approaching it, is that, as availability of oral therapies becomes broader, they're used relatively early in the course of disease. Many people may progress and or not get treated early enough and end up in the hospital.

For both oral and IV therapies, there will be up.

What we're seeing now I think in terms of how folks are approaching it is that.

<unk>.

Availability of oral therapies becomes broader they are used relatively early in the course of disease.

Many people may progress and or not get treated early enough and then up in the hospital and at that point, I think thats, where that hospitalized or Perry hospitalization and more severe disease is where the role of IV therapy is going to come in and the clearing in particular is going to come in so too much to add to what Joanna said I do think there'll be.

Merdad Parsey: And at that point, I think that's where the role of IV therapies is going to come in, and that glurine in particular is going to come in. So I have too much to add to what Johanna said, but I do think there'll be a role for both in the long run. And Hortaje, just to compliment what Johanna and Merdad said, I think, you know, we clearly see that, as this becomes endemic, there'll be potentially a need for multiple mechanisms in the outpatient setting.

A role for both in the long run hotels just to.

Complement one Joanna and where that said I think we clearly see that.

As this becomes endemic that there'll be a potentially a need for multiple mechanisms in the outpatient setting. So that's one of the reasons why.

Merdad Parsey: So that's one of the reasons why, you know, approaching it from a preliminary standpoint as well as from a protease standpoint, we think could make sense over the long term for resistance patterns. And the last thing I'll say is I think when we've seen this before, whether it's a pandemic or endemic. Remdesivir is going to firmly entrench itself now as a standard of care in the hospital setting.

Approaching it from a preliminary standpoint as well as the Proteus standpoint, we think could make sense over the long term for resistance patterns and the last thing I'll say is I think we've seen this rather its pandemic or epidemic.

Industrial was firmly.

Trench now as the standard of care in the hospital setting and so as goes hospitalizations. So we'll go run that severe over time, and we think that's going to be an important part of our ongoing business and our benefits in patients.

Daniel O'Day: And so as hospitalization goes, so will remdesivir over time. And we think that's going to be an important part of our ongoing business and our benefit to patients. With that, thank you, we'll move on to the next question, please. Our next question comes from the line of Carter Gould from Barclays. Your line is now, Great. Thank you. Good afternoon.

With that thank you will.

Move on to the next question please.

Our next question comes from the line of BARDA goal from Barclays. Your line is now open.

Operator: Thanks for taking the question. I wanted to come back to Tredelvey, but a little bit more from the commercial and strategic angle, and wanted to, you know, just sort of the decision to triple the sales force. At this point, ahead of Tropics 2, is that decision dependent upon positive data from Tropics 2, or could that potentially be revisited depending on that outcome? And then specifically around what you're seeing with the sales, it seems like the growth on an absolute basis, quarter on quarter, it does seem to be. I'm slowing down a bit.

Great. Thank you. Good afternoon. Thanks for taking the question I wanted to come back to <unk>, but a little bit more from the commercial and strategic angle and wanted to just sort of a decision to triple the sales force at this point ahead of ahead of tropics too.

Is that decision dependent upon positive data from tropics, two or could that potentially be revisited depending on that outcome and then specifically around sort of what youre seeing in the sales it seems like that.

The growth on an absolute basis quarter on quarter, it does seem to be sort of.

Slowing a bit can you maybe just talk about how the real world.

Carter Gould: Can you maybe just talk about how the real world, you know, duration of use has maybe evolved and if that's sort of in line with what you saw in the studies? Thanks, Carter. Right over to Johanna, please.

Alright duration of use has maybe evolved and if thats sort of in line with what you saw on the studies in the pivotal studies. Thank you. Thanks.

Johanna Mercier: Sure, Carter. Thanks for the question. Just a couple of things. One is the footprint, the geographic footprint that we've just initiated with that ramp up and the tripling. It has really maybe three objectives.

Thanks, Carter right over to Joanna sure Carter, Thanks for the question.

Just a couple of things one is the footprint the geographic footprint that we've just initiated and that that ramp up and the tripling. It has really maybe three objectives one is to <unk>.

Johanna Mercier: One is to further support our initial launches of both metastatic TNVC as well as bladder. That's definitely number one, and that is here and now. The potential to support a potential indication in HR positive, which is what you were referring to.

Their support our initial launches at both metastatic CNBC as well as bladder that's definitely number one in that it stay here now.

The potential to support.

A potential indication in HR positive, which is what you were referring to and the third one is also setting up for the future success of our total oncology portfolio.

Johanna Mercier: And the third one is also setting up for the future success of our total oncology portfolio. So assuming positive data, of course, is what we've decided to go for. But having said that, even if that didn't play out, this is the right team for the future of Gilead Oncology.

Yes.

Assuming positive data of course is what we've decided to go far but.

But having said that.

Even if that Didnt play out with this is the right team for the future for Gilead oncology.

Johanna Mercier: So that was the first part of your question. The second part of your question about the growth slowing, I actually think we're quite pleased, actually, as we got into Q4. What we've seen is the share really driving up post-NCCN breast guidelines update in September, and so we had a good data point on share. The last data point we have is October, and that's the one in four that you heard me talk about earlier. And so that's doubling from where we were in April. So we were at about half of that share in the second line. And now we're at about 24, 25 percent share in the second line.

So that was the first part of your question.

The second part of your question about the growth slowing as we think we're quite pleased actually as we got into Q4, what we've seen is.

The share really drive up post MCC and breast guidelines update in September and so we had good data point of share. The last data point. We have is October and that's the one in four that you heard me talk about earlier and so that doubling from where we were in April . So we were at about half of that share in second line and now we are at about 24, 25% share in second line, so a real nice growth.

Johanna Mercier: So really nice growth on that front, and definitely more to come. I think there's an incredible opportunity for Trudelvie in this patient setting, especially with the high medical need and the incredible OS data that we have with Trudelvie. So more to come on that.

On that front and definitely more to come I think there is an incredible opportunity for <unk> in this patient setting, especially with a high unmet medical need and the incredible data that we have with <unk>, so more to come on that.

Johanna Mercier: Terrific. Thank you so much, Carter. We can take one last question, everybody.

Terrific. Thank you so much Carter, we can take one last question everybody. Thank you.

Thank you. Our last question comes from the line of Matthew Harrison from Morgan Stanley . Your line is now open.

Operator: Thank you. Thank you. Our last question comes from the line of Matthew Harrison from Morgan Stanley. Your line is now open.

Great. Good evening, Thanks for fitting me in just one clarification and one question so forth.

Matthew Harrison: Great. Good evening. Thanks for fitting me in. There is just one clarification and one question. So first, Merdad, can you just clarify? It was unclear to me from your comments whether the FDA had asked for the OS data, and that's why you were including this interim now for the filing, or if that had been your plan all along. And then second, any comments you can make specifically around the stocking tailwind as well as the gross net tailwind that you had from HIV in the fourth quarter?

My Dad can you just clarify it was unclear to me from your comments, whether the FDA had asked for the OS data and that's why you were including this interim now for the filing or if that had been your plan all along so if you could just clarify that would be great and then second any comments you can make specifically around.

The stocking tailwind as well as the gross to net tailwind that you had from HIV in the fourth quarter.

Matthew Harrison: Thank you. Thanks a lot, Matthew, and then Johanna. Yeah, very quickly, I think, as I mentioned, we did an outsize study last year for OS because we've always believed, especially in HR positive, that having OS data is going to be important to support a file.

Hello, Matthew.

Got it and then Joanne Yeah very quickly I think as I mentioned, we did upsize. The study last year for Oss because we've always believed especially in Asia are positive having OS data are going to be important to support a file it's not the primary endpoints.

Merdad Parsey: It's not the primary end point, and we think it's going to be important, supportive data to go. So that didn't really have much to do with this confluence of events here. It's a fortuitous event in terms of timing here that will support our data. So hopefully, that answers the question. The FDA did not specifically ask us for it.

And we think it's going to be important supportive data to go so.

That didn't really have much to do with this confluence of events here.

Merdad Parsey: No, it's always, we were always going to take a look at OS with the first PFS data cut. At this point, in order, instead of doing a look and then an interim, we're just going to do the PFS and the interim at the same time. And Matthew, the second part of your question around the Q4 piece of the puzzle. So, as you well know, right, as you go into Q4, you usually have a bit of a seasonal inventory build and subchannel play. And then, of course, that bleeds out in Q1. So that's one piece of the puzzle in Q1. The other difference is, of course, you increase your copay support, your donut hole coverage.

It's a fortuitous event in terms of timing here that will support our data so hopefully that the FDA did not ask for it. After you didn't specifically ask us for it I would say, it's always we're always going to take a look at OS with the first PFS.

Data cut at.

At this point.

Instead of doing a look and then an interim we're just going to do the PFS and the interim at the same time.

Thanks Matthew.

Matthew the second part of your question around Q4 piece of the puzzle. So as you well know right. As you go into Q4 are usually have a bit of a seasonal inventory build in sub channel play and then of course that bleeds out in Q1. So that's one piece of the puzzle in Q1. The other differences of course, you increased your co pay support year donut hole coverage.

Johanna Mercier: And so all those pieces and your payer mix kind of change in your first quarter. Having said that, in addition to that, there was some favorability in Q4 of 2021 from a growth to net standpoint, which will then create an even bigger kind of decline in Q1. And that's what we were referring to. So hopefully, that helps a little bit. It's a one-time thing in Q4. And it's just more around the comparison versus Q1 over Q4 as we get through the first quarter. And that's what I was trying to signal.

And so all of those pieces and your payer mix kind of changes in your first quarter, having said that in addition to that there.

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Some favorability in Q4 of 2021 from a gross to net standpoint, which which will then create an even bigger kind of decline in Q1 and thats. What we were referring to so so hopefully that helps a little bit it's a onetime thing in Q4.

And it's just more about the comparison versus Q1 over Q4 at least as we get through the first quarter.

I was trying to signal.

Daniel O'Day: Great, Matthew. And just want to, before I turn it over to Jackie, thank all of you for joining us. From our perspective, we are really excited about the build that we've had at Gilead over the past two years and the team and the people that we have on board. We've got a lot to do this year, and we're really teed up for a good, strong year and a strong decade ahead with this portfolio.

Great Matthew and just want to before I turn it over to Jacky. Thank all of you for joining from our perspective, we are really excited about the build that we've had at gilead over the past few years and the team and the people that we have on board, we've got a lot too.

This year, we're really teed up for a good strong year in a strong decade ahead with this portfolio could that Jackie over to you. Please.

Daniel O'Day: With that, Jackie, over to you. Thank you, Dan, and thanks to our operator, Gigi, for your help today, and indeed to all of you for joining us. We appreciate your continued interest in Gilead and hope that you can join us for our virology deep dive scheduled for Thursday, the 17th of February. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Thank you Dan and thanks to our operator for your help today and indeed all of you for joining US. We appreciate your continued interest in Gilead and hope that you can join us for our virology deep dive scheduled for Thursday, the 17th of February . Thank you.

This concludes today's conference call. Thank you for participating you may now disconnect.