Q3 2021 Gilead Sciences Inc Earnings Call

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Speaker from Gilead: a significant reduction in the risk of hospitalizations after a three-day IV treatment of Vicklury in the outpatient study. In order to meet additional treatment needs, we also continue to advance our oral programs to develop a novel best-in-class therapy. Turning to HIV performance, we saw positive gains in the treatment market for the second quarter in a row and reported record revenue for Big Tarvey. While treatment prescription volumes remain below pre-pendemic levels, we maintain total U.S. and EU treatment market share, and we grew Big Tarvey share sequentially in both geographies.

It is a significant reduction in the risk of hospitalization. After three day IV treatment effect glory in the outpatient setting.

In order to meet additional treatment needs. We also continue to advance our oral programs to develop a novel best in class therapy.

Turning to HIV performance, we saw positive gains in the treatment market for the second quarter in a row and reported record record revenue for big target.

While treatment prescription volumes remain below pre pandemic levels, we maintained total U S and EU treatment market share and we grew big target share sequentially in both geographies.

Speaker from Gilead: The pre-filled market continues to recover, and our pre-filled market share is holding steady despite generic entry. Overall, our third-quarter results give us confidence that the HIV market is recovering from the pandemic, and our market share clearly highlights Gilead's strong market position. As a result of the strong quarter, we have increased our full year revenue and earnings per share guidance. Becleri now looks set to deliver close to twice the revenue we expected at the start of the year.

The prep market continues to recover and our market share is holding steady despite generic entry.

Overall, our third quarter results give us confidence that the HIV market is recovering from the pandemic and our market share clearly highlights gilead strong market position.

As a result of the strong quarter, we have increased our full year revenue and earnings per share guidance.

Clearly now look set to deliver close to twice the revenue we expected at the start of the year.

Speaker from Gilead: While our base business has clearly been affected by COVID, it has also shown resilience. At the guidance midpoint, we are now expecting full year total revenue to be $1.75 billion higher than we expected at the start of the year.

While our base business has clearly been affected by Covid. It has also shown resilience.

At the guidance midpoint, we are now expecting full year total revenue to be $1 $75 billion higher than we expected at the start of the year.

Speaker from Gilead: Our confidence in the longevity of our HIV business is in part based on our progress in developing the next generation of HIV therapy and prevention. Lena Capovir is the cornerstone of that work, and we have four clinical trials evaluating Lena Capovir across treatment and prevention, highlighting our efforts to extend the options available to people living with or at risk of HIV. This quarter, Lena Capadier was granted FDA priority review for the heavily treatment-experienced population.

Our confidence in the longevity of our HIV business is in part based on our progress in developing the next generation of HIV therapy and prevention.

<unk> is a cornerstone of that work and we have four clinical trials evaluating Atlantic cap of your across treatment and prevention highlighting our efforts to extend the options available to people living with or at risk of HIV.

This quarter Atlanta cap area was granted FDA priority review for heavily treatment experienced population.

Speaker from Gilead: As a reminder, Lena Capavir has breakthrough therapy designation and, if approved, would be the first long-acting treatment for people living with HIV who have multi-drug resistance, as well as the first available six-month-long-acting subcutaneous injection treatment for HIV.

As a reminder, lantern catheter has breakthrough therapy designation and if approved will be the first long acting treatment for people living with HIV, who have multi drug resistance as well as the first available six months long acting subcutaneous injection treatment for HIV.

Speaker from Gilead: As you know, we signed an agreement with Merck earlier this year to explore combinations of Lenocapivir and a slatrevier in long-acting treatment. Earlier this week, we announced the start of a phase two study with Merck, evaluating lenticaphaver and a slatterir long-acting oral combination treatment. Our approach to long acting is very much shaped by people living with HIV. We've heard that they would welcome weekly oral or infrequent subcontaneous injections that could coincide with routine office visits or even be taken at home. The advantages of these options include greater convenience, the potential for stronger adherence, and privacy.

Separately as you know we signed an agreement with Merck earlier this year to explore combinations of Atlantic cap of air and <unk> and long acting treatment.

Earlier this week, we announced the start of a phase III study with Merck evaluating Atlantic <unk> long acting oral combination treatment.

Our approach to long acting as very much shaped by people living with HIV. We have heard that they would welcome weekly oral or infrequent subcutaneous injections that could coincide with routine office visits or even be taken at home.

The advantages of these options include greater convenience the potential for stronger adherence and privacy.

Speaker from Gilead: Lana Capavir has shown promising potential in both oral and some cutaneous injections, and we will continue to advance both options while updating you on our progress throughout. Meanwhile, while extending our leadership in HIV, we are also executing on the significant potential in our broad and diverse oncology portfolio. This is potential that could bring transformational benefits for people with cancer and value for our stakeholders. Third-third highlights include the initiation of two solid tumor trials for Magrolumab in Head and Neck Cancer and a multi-tumar basket study.

<unk> has shown promising potential in both oral and subcutaneous injections and we will continue to advance both options, while updating you on our progress throughout.

While extending our leadership in HIV. We are also executing on the significant potential in our broad and diverse oncology portfolio.

This is a potential that could bring transformational benefits for people with cancer and value for our stakeholders.

Third quarter highlights include the initiation of two solid tumor trials from our <unk> head and neck cancer and a multi tumor basket study.

Speaker from Gilead: We plan to initiate an additional pastry study in first-line, unfit acute myeloid leukemia, or AML, in early 2022. The FDA approval of Ticardis for adult relapse and refractory acute lymphoblastic leukemia, or A-L-L-L, is our fourth approved indication in cell therapy.

We plan to initiate an additional phase III study in first line unfit acute myeloid leukemia or AML in early 2022.

The FDA approval of <unk> for adult relapsed and refractory acute lymphoblastic leukemia or AML.

Is our fourth approved indication in cell therapy. Additionally, the <unk> team has filed an S. BLA for <unk> in second line <unk>, which if approved would be the first car T therapy in an earlier line setting.

Speaker from Gilead: Additionally, the Kite team has filed an SBL for Yuskarta and second-line LBCL, which, if approved, would be the first KARTE therapy in an earlier stage setting, and a positive CHMP opinion for Trudeleby in second-line metastatic triple-angular breast cancer earlier this month. We expect an approval decision from the European Commission later this year, and this could potentially be our sixth approval for Trudelevy in Additionally, we've just announced a new clinical trial collaboration and supply agreement with Merck to evaluate the combination of Gilliads Trope 2 antibody drug conjugate Trudelevy with Merck's anti-PD1 therapy, Katruda, for the treatment of first-line metastatic triple negative breast cancer.

And a positive CHF see HMP opinion for <unk> in second line metastatic triple negative breast cancer earlier. This month, we expect an approval decision from the European Commission later this year and this could potentially be our sixth approval for <unk> in triple negative breast cancer in 2021.

Additionally, we have just announced a new clinical trial collaboration and supply agreement with Merck to evaluate the combination of Gilead stroke, two antibody drug conjugate toward Lv with merck's anti PD, one therapy keytruda for the treatment of first line metastatic triple negative breast cancer.

Speaker from Gilead: When we acquired Immun Medics last year, we said that we would explore the use of Trudelevy across a wide range of tumor types and that we would pursue combinations with both internal and external molecules. You can see this start to play out now with this Merck partnership as an early example of our approach. Next, on slide five, I'm pleased to note that we delivered on three of our target milestones for the quirk.

When we acquired Immunomedics last year, we said that we would explore the use of <unk> across a wide range of tumor types and then we would pursue combinations with both internal and external molecules.

You can see that start to play out now with this Merck partnership as an early example of our approach.

Next on slide five I am pleased to note that we delivered on three of our target milestones for the quarter.

Speaker from Gilead: You will also note that the timelines for Tropic 2 and the Phase 1B McGrolamab have shifted, as we now expect to have the PFS readout for Tropic 2 in late January or early February, and the top line readout for Phase 1B McGrolamab in the first quarter of 2022.

You'll also note that the timelines for traffic two and the phase one b Mcgraw amount have shifted as we now expect to have the PFS readout for tropics too in late January early February and the top line readout for the phase <unk> in the first quarter of 2022.

Speaker from Gilead: Merdad will also touch on this later in the call, but as you know, these modest timeline adjustments are quite normal in oncology, especially event-driven trials like tropics. We look forward to sharing these updates in the first quarter of 2022. Taken as a whole, our oncology portfolio now spans some of the most promising targets in the field today. In addition to Trudeleve for Trope 2, CD-47, and cell therapy, these include Tidget, adenosine, and many others.

Mehrdad will also touch on this later in the call, but as you know these modest timeline adjustments are quite normal in oncology, especially event driven trials like <unk> too.

We look forward to sharing these updates in the first quarter of 2022.

Taken as a whole our oncology portfolio now spend some of the most promising targets in the field. Today. In addition to <unk> for Chubb to CD 47, and cell therapy. These include ticket adenosine and many others.

We are very encouraged by the momentum across these programs and look forward to sharing much more in the coming quarters.

Speaker from Gilead: We are very encouraged by the momentum across these programs and look forward to sharing much more in the coming quarter. The positive momentum overall in the third quarter gives us great confidence in the direction we are taking and the pace of our progress.

The positive momentum overall in the third quarter gives us great confidence in the direction, we are taking and the pace of our progress we are well on our way with the plans to sustain our leadership in HIV and while there is much more to comment oncology, we've already begun to execute on the potential in our highly promising portfolio.

Thanks, Laurie is making a significant impact as the pandemic continues to evolve and we are well placed for when the HIV market bounces back.

Speaker from Gilead: We are well on our way with the plans to sustain our leadership in HIV, and while there is much more to come in oncology, we've already begun to execute on the potential in our highly promising portfolio, but Gloria is making a significant impact as the pandemic continues to evolve, and we are well placed for when the HIV market bounces back. I want to thank all the Gilead and Cide employees around the world who are making all this possible with their passion for scientific excellence and their commitment to global public health. With that, I'll hand over to Joanna, who will give an update on commercial performance in the third quarter. Thanks, Dan, and good afternoon, everyone.

I want to thank all the Gilead and kite employees around the world, who are making all of this possible with their passion for scientific excellence and their commitment to global public health.

With that I'll hand over to Joanna who will share an update on the commercial performance in the third quarter.

Thanks, Dan and good afternoon, everyone.

As you can see on slide seven total product sales of $7 4 billion increased 13% year over year, primarily driven by declaring excluding decorate total product sales were $5 4 billion down 3% year over year, primarily due to the impact of the Truvada and triplet Emily.

Offset by continued growth in <unk> and contributions from our new medicine, such as 2000.

On slide eight sales of $1 9 billion were up 132% sequentially and reflected strong U S demand consistent with the recent surge in Covid cases, including the Delta variant.

Over 60% of patients hospitalized with COVID-19 in the U S with feedback Larry and we continue to expect a great deal to track hospitalization, which you can see peaked at the end of August and had been declining ever since.

Speaker from Gilead: As you can see on slide 7, total product sales of 7.4 billion grew 13% year-over-year, primarily driven by Vicklery. Excluding Vicklery, total product sales were 5.4 billion down 3% year-over-year, primarily due to the impact of the Truvada and the TRIPLA LOE, offset by continued growth in Victoria and contributions from our new medicines such as Terdel's, On slide 8, the Declari sales of $1.9 billion were up 132% sequentially and reflected strong U.S. man consistent with the recent surge in COVID cases, including the Delta variant.

Moving to HIV on slide nine revenue of $4 2 billion grew 6% sequentially driven by favorable net pricing and strong demand for <unk>, partially offset by continuation of the trends towards the less favorable payer mix.

Our sequential trends were strong total HIV revenues were down 8% year over year, given the impact of the Truvada Triple <unk> and lower channel inventory, primarily driven by pandemic related stocking in the prior year.

Excluding the impact of <unk>.

HIV revenues were up 4% year over year.

Overall, we are encouraged by the improving trends in HIV treatment. Thank you.

JV treatment market grew about 3% sequentially, suggesting a modest pick up in the recovery that started in Q2.

Speaker from Gilead: Over 60% of patients hospitalized with COVID-19 in the U.S. received Veclary, and we continue to expect Ecclary sales to track hospitalizations, which you can see peaked at the end of August and have been declining ever since. Moving to HIV on slide 9, revenue of 4.2 billion grew 6% sequentially, driven by favorable net pricing and strong demand for Bictarvy, partially offset by continuation of the trends towards the less favorable payer While sequential trends were strong, total HIV revenues were down 8% year-over-year, given the impact of the Travada AAA LOEs and lower channel inventory, primarily driven by pandemic-related stocking in the prior year. Excluding the impact of the LOEs, HIV revenues were up 4% year over year.

Our share of the overall U S. HIV treatment market continues to hold steady at approximately 75%.

And reflecting the modest pandemic recovery and strong share gains.

Harvey revenues grew 20% year over year, and 14% sequentially to a record $2 3 billion.

<unk> revenue of $433 million was flat quarter over quarter, driven by increased demand in inventory offset by lower net price.

We continue to see recovery year to date with the market growing 12% quarter over quarter and are encouraged to see discovery share holding steady around 45%. Despite the availability of multi source generic versions of Truvada.

Next on Slide 10, <unk> continues to gain market share sequentially and year over year, both in the U S and EU five.

We are particularly pleased to see sequential quarterly growth of one 5% in the U S and 1% in the EU five, especially given the tablet leading market share.

We're proud to see continued uptake of the Kirby now capturing 41% of the total treatment market in the U S with more than 57% of people living with HIV starting treatment on <unk>.

Speaker from Gilead: Overall, we're encouraged by the improving cans and HIV treatment. The USAID treatment market grew about 3% sequentially, suggesting a modest pickup from the recovery that started in Q2. Our share of the overall US HIV treatment market continues to hold steady at approximately 75%. Reflecting the modest pandemic recovery and strong share gains, Victoria revenue grew 20% year over year and 14% sequentially to a record 2.3 billion. SCOBE revenue of $433 million was flat quarter over quarter driven by increased demand and inventory offset by a lower net price.

On slide 11, HCV revenue of $429 million was down 8% year over year, primarily driven by favorable settlement in the third quarter of 2020 that did not repeat your patients outside of the U S and the timing of the department of corrections purchases on a relative basis.

Sequentially HCV revenue declined 22%.

Due to inventory dynamics, including a sizeable purchased by the department of corrections in the prior quarter and fewer patient starts.

Although starts improved in some geographies year over year, we saw sequential declines in the U S and Europe, driven driven by continued pandemic related impact on patient visits and lower testing volumes in additional in addition to normal seasonality.

Speaker from Gilead: We continue to see recovery year to date with the Prack market growing 12% quarter over quarter and our encouraged see Discovy Shareholding study around 45% despite the availability of multisourced generic versions of Trubata. Next on slide 10, Victoria continues to gain market share sequentially and year-over-year, both in the U.S. and the U.5. We are particularly pleased to see sequential quarterly growth of 1.5% in the US and 1% in the EU5, especially given Vittarvey's leading market. We're proud to see continued uptake of Victorvi now capturing 41% of the total treatment market in the U.S., with more than 57% of people living with HIV starting treatment on Victorvi.

However, we continue to be pleased that gilead HDD market share is holding steady around 60% in the U S and just about 50% in the EU five.

Moving to slide 12.

<unk> HBV in HDD revenues of $247 million were up 17% year over year, driven by them Lady demand in international markets and the addition of <unk> to our portfolio.

Q3 revenue for <unk> was $12 million, reflecting sales now in Germany, France, Austria and Greece.

We are actively working with government authorities to secure full reimbursement in the major European markets in 2022.

Moving to <unk> on slide 13, third quarter revenue of $101 million grew 13% quarter over quarter, driven by increased share in metastatic <unk> in part due to the expansion to second line to.

<unk> was approved for second line metastatic CNBC in the U S. In April and we already estimate that approximately 15% of second line patients are receiving <unk>.

In the third line or later setting we estimate estimate that about a third of patients with metastatic <unk> seeking to Adobe.

And your feel Youll cancer at least wanting for bladder cancer patients in the third line or later setting start treatment on <unk>.

Speaker from Gilead: On slide 11, HCB revenue of 429 million was down 8% year over year, primarily driven by a favorable settlement in the third quarter of 2020 that did not repeat, fewer patient starts outside of the U.S., and the timing of Department of Corrections purchases on a relative basis. Sequentially, HGV revenue declined 22% due to inventory dynamics, including a sizable purchase by the Department of Corrections in the prior quarter and fewer patients. Although starts improved in some geographies year over year, we saw sequential declines in the U.S. and Europe, driven by continued pandemic-related impact on patient visits and lower testing volumes in addition to normal seasonality. However, we continue to be pleased that Gilead HCD Market Share is holding steady around 60% in the U.S. and just about 50% in the EU 5. Moving to slide 12.

And with adoption in second line still early there is continued opportunity for growth across both setting.

We're pleased with the uptake so far and remain focused on broadening physician awareness with community settings.

Following recent FCC and breast cancer at ESMO clinical guideline update Stalvey is now included as a preferred regimen in second line metastatic can be seen both guidelines and we expect it.

<unk> further adoption.

We are preparing the first commercial launches of <unk> for metastatic <unk> in Great Britain, Australia, Canada, and Switzerland and.

And later this year, we are expecting a decision from the European Commission. Following the recent positive opinion from the CHP.

Next on slide 14, and on behalf of Christie and the kite team our cell therapy products grew 51% year over year to $222 million. This was driven by LDC, all demand and strong launches in both mantle cell lymphoma, and follicular lymphoma more than offsetting the expected impact of new U S entrants bcm.

Speaker from Gilead: HV and HDV revenues of 247 million were up 17% year over year, driven by VAMLIDI demand in international markets and the addition of HECUTCS to our portfolio. C3 revenue for Hepcludix was 12 million, reflecting sales now in Germany, France, Austria, and Greece. We are actively working with government authorities to secure full reimbursement in the major European markets in 2020. Moving to Gidele on slide 13, third-quarter revenue of 101 million grew 13% quarter-percent, driven by increased share in metastatic TNBC, in part due to the expansion to the second line.

With the.

<unk> of our new Mcl NFL indications, we are particularly proud that we have maintained our best in class manufacturing operations within 97% reliability rate.

To support our expected growth, we are working to bring our new Maryland facility online in mid 2022, which will automate many of our manual processes and reduce costs.

We also wanted to highlight the recent FDA approval of <unk> in adult all.

This makes <unk>, the first and only car T therapy now available to these eligible patients in the U S.

The <unk> team has also filed a supplemental BLA for <unk> in second line, or Bcl, which would bring us one step closer to potentially carrying even more patients.

Christy's here with the team and available to take questions on cell therapy during the Q&A and with that I'll hand, it over to Murdo for pipeline update.

Thank you Joanna.

As always I'll focus today on the most important updates and refer you to the appendix of the earnings presentation for a more comprehensive view of our pipeline programs.

Speaker from Gilead: Tadelvey was approved for second-line metastatic TNBC in the U.S. in April, and we already estimate that approximately 15% of second-line patients are receiving Tredelva. In the third line or later setting, we estimate that about a third of patients with metastatic TNBC are receiving Delta. In urethelial cancer, at least one in four bladder cancer patients in the third line or later setting start treatment with Tredelva. And with adoption and second line still early, there's continued opportunity for growth across both settings.

First on slide 16 in HIV prevention, we've initiated the 5000 plus participant phase III purpose, one trials setting Linda cat severe for the prevention.

And adolescent girls and young women, who are at risk of HIV infection.

We're also in the initial stages of recruiting for purpose to to evaluate lending half of year for prevention and over 3000, cisgender men transgender and gender nonbinary, who have sex with men. We will provide updated timelines once enrollment is further along.

In HIV treatment. The FDA granted priority review in August for lending cap a year for the treatment of people living with HIV, who have developed multi drug resistance to other anti retrovirals.

Speaker from Gilead: We're pleased with the uptake so far and have remained focused on broadening physician awareness and community setting. Following recent NCCN breast cancer anasmo clinical guideline updates, Tidelby is now included as a preferred regimen in second-line metastatic CNBC in both guidelines, and we expect this will drive further adoption. We are preparing the first commercial launches of TEDELB for Metastatic TNBC in Great Britain, Australia, Canada, and, Later this year, we are expecting a decision from the European Commission following the recent positive opinion from the CHMP.

This is based on compelling capella data that demonstrated 81% of heavily treatment experienced individuals' achieved viral suppression when linea <unk> combined with an optimized background regimen.

The <unk>.

Action date has been set for February 28, 2022, and if approved <unk> would become the first available six months long Actings hub.

Cutaneous injection treatment for HIV.

Earlier this week, we announced that enrollment has started for the phase III trial.

So the long acting oral combination of <unk> here.

This is part of our collaborative work with Merck to develop more flexible options for people living with HIV with a once weekly oral pill Julie.

Speaker from Gilead: Next, on slide 14, and on behalf of Christy and the kite team, our cell therapy products grew 51% year-over-year to 222 million. This was driven by LBCL demand and strong launches in both mantle cell lymphoma and follicular lymphoma, more than offsetting the expected impact of new U.S. entrance into LBC. With the addition of our new MCL and FL indications, we are particularly proud that we have maintained our best-in-class manufacturing operations within a 97% reliability rate. To support our expected growth, we are working to bring our New Maryland facility online in mid-2020, which will automate many of our manual processes and reduce costs.

Gilead is leading the development and clinical work for this oral combination and Merck is leading the clinical work for the injectable combination that is expected to enter phase one clinical trials next year.

Moving to <unk> on Slide 17, we presented a late breaker at the <unk> 2021 conference last month based on the phase III Pine tree study evaluating <unk> as an outpatient intravenous COVID-19 treatment.

The results demonstrated that a three day course of <unk> significantly reduced the risk of hospitalization for high risk patients with COVID-19.

In particular, clearly demonstrated a statistically significant 87% reduction in risk the composite primary endpoint of COVID-19 related hospitalizations or all cause mortality by day 28 compared with placebo.

No deaths in either arm of the study by day 28.

We stopped pine tree enrollment at the halfway Mark of 584 patients in April due to the COVID-19 landscape at the time, but the study remains blinded and collected outcome data and the enrolled patients upon analysis of those data. The results were highly statistically significant and clinically meaningful again, demonstrating the efficacy of victory.

Speaker from Gilead: We also wanted to highlight the recent FDA approval of Taccardis in adult ALL. This makes Ticardis the first and only cartilage therapy now available to these eligible patients in the U.S. The Kite team has also filed a supplemental BLA for Yaskarta in second-line LBCL, which would bring us one step closer to potentially curing even more patients. Christy is here with the team and available to take questions on cell therapy during the Q&A. And with that, I'll hand it over to Murad for Pipeline Ops. Thank you, China.

It also emphasizes the importance of early treatment with anti viral therapies.

We have submitted these data to the FDA as an SMB E filing and are in discussions with other regulatory agencies to explore approval for IV <unk> in an outpatient setting.

We're also continuing our work to develop novel oral antivirals for the treatment of COVID-19.

Moving to slide 18, we continue to view <unk> as a pipeline in a product to Adobe targets Trop, two which is over expressed in many solid tumor cells. So we believe that <unk> can have a meaningful impact on a wide range of cancers. In addition to the second line metastatic <unk> in second line bladder indications that are approved today.

Speaker from Gilead: As always, I'll focus today on the most important updates and refer you to the appendix of the earnings presentation for a more comprehensive view of our pipeline program. First, on slide 16, in HIV prevention, we've initiated the 5,000-plus participant, phase three, purpose one trials studying Lena Capoevere for prevention and adolescent girls and young women who are at risk of HIV infection. We're also in the initial stages of recruiting for purpose two to evaluate Lening Kappavir for prevention in over 3,000 cisgender men, transgender, and gender non-binary who have sex with men. We will provide updated timelines once enrollment is further along.

We're all eagerly anticipating the readout from the phase III tropics, <unk> study, a randomized phase III trial in HR positive <unk> negative metastatic breast cancer.

As a reminder, this is an event driven trial evaluating disease progression and we have not yet achieved the target number of events as such we now expect to have the topline data readout in late January or early February to be clear data analysis will only begin once we achieve the required number of events we remain confident.

Confident for the potential <unk> to deliver a clinically meaningful benefit to patients with HR positive <unk> negative metastatic breast cancer.

We also continue to advance <unk> into Registrational studies for other indications for example, as recently posted on <unk> Dot Gov. We.

We plan to initiate the phase III trial in second to third line non small cell lung cancer at risk and look forward to sharing updates for other solid tumors as we expand the program as Dan mentioned, we will also start to work with Merck on a new clinical study looking at <unk> in combination with Merck's Keytruda for first line metastatic CNBC and plan to initiate the trial in the first half.

Speaker from Gilead: In HIV treatment, the FDA granted priority review in August for Lenda Capavere for the treatment of people living with HIV who have developed multi-drug resistance to other antiretrovirs. This is based on compelling Capella data that demonstrated 81% of heavily treatment-experienced individuals achieved viral suppression when Lena-Capavir was combined with optimized background recognition. The Badoopin action date has been set for February 28, 2022, and if approved, Lenna Cappavir would become the first available six-month long-acting subcutaneous injection treatment for HIV.

2022.

Moving on to Slide 19, we continue to believe that with its synergistic potential and the safety profile observed to date gorilla math could benefit patients with a variety of hematologic and solid tumors.

As you know our initial focus has been Mds and AML.

Our commitment to these patients remains unchanged, we continue to evolve our clinical programs in the context of the recent development in the Mds therapeutic landscape.

The ongoing phase III enhance trial evaluating <unk> in higher risk Mds is on track and enrolling well, we will discuss our development plans and regulatory path forward with the FDA before the end of the year.

Speaker from Gilead: Earlier this week, we announced that enrollment had started for the Phase 2 trial for the long-acting oral combination of Lena-Capavir and S. Latrobe. This is part of our collaborative work with Merck to develop more flexible options for people living with HIV who need a once-weekly oral pill. Dillette is leading the development and clinical work for this oral combination, and Merck is leading the clinical work for the injectable combination, which is expected to enter phase one clinical trials next year.

Meanwhile, the data from our phase one B trial continues to mature and we now expect to share top line data in the first quarter of 2022.

Looking beyond Mds are enhanced two trial from the <unk> and <unk>.

First line <unk> three mutant AML is ongoing targeting a new therapeutic option for nearly 2000 patients in the U S.

In addition, an estimated 6000 patients in the U S are diagnosed and treated annually with unfit AML. So we're expanding our development efforts to initiate the phase III trial for first line unfit AML by early next year.

Speaker from Gilead: Moving to Bicklure on slide 17, we presented the late breaker at the ID Week 2021 conference last month based on the phase three pine tree study evaluating Bicklory, an outpatient intravenous COVID-19 treatment. The results demonstrated that a three-day course of the gluary significantly reduced the risk of hospitalization for high-risk patients with COVID-19. In particular, Ciclory demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalizations or all-caused mortality by day 28 compared with placebo. There were no deaths in either arm of the study by day 28.

Over the past few months, we've initiated two solid tumor trials from our roadmap one in head and neck cancer and a separate solid tumor basket study for patients with non small cell lung cancer small cell lung cancer and <unk> cancer.

We also plan to initiate a third study in metastatic <unk> based on broad CD 47 expression, we're excited by them and grow them adds potential to be an effective therapy for solid tumors and look forward to sharing more updates as they become available.

Next on behalf of Christiana Mackay team I also wanted to highlight the most recent approval for <unk> in adults with relapsed or refractory <unk> on slide 20.

There is an incredibly high unmet need for these patients with 50% of adult patients relapsing on currently available treatments.

The approval was based on data from Zuma, three which demonstrated 65% of patients achieved complete remission.

Additionally, as Joanna mentioned earlier, Kate has filed the S. BLA for <unk> in second line <unk>.

With the medium follow up of two years. The study met the primary endpoint of event free survival hazard ratio of 0.3 hundred 98.

Speaker from Gilead: We stopped Pintree enrollment at the halfway mark of 584 patients in April due to the COVID-19 landscape at the time, but the study remained blinded and collected outcome data in the enrolled patients. Upon analysis of those data, the results were highly statistically significant and clinically meaningful, again demonstrating the efficacy of the treatment. It also emphasizes the importance of early treatment with antiviral therapy. We have submitted these data to the FDA as an SNDA filing and are in discussions with other regulatory agencies to explore approval for IV Vickory in an outpatient setting.

And a P value of less than <unk> 0001 rep.

Representing a potentially significant advance in the standard of care for <unk> patients.

We look forward to reviewing the entire dataset at Ash and expect an update next year on approval status.

Lastly, moving to slide 21, we remain very excited about our oncology partners, whose work spans many promising new pathways in oncology for example, our partners.

ARCUS.

Has the pipeline that includes not only anti tissue candidates, but also <unk> 73, an adenosine receptor inhibitors to promote immune responses and inhibit tumor growth.

We continue to expect to trigger the opt in review period for ARCUS as dumb dumb math likely.

Likely later this year or early next year pending the review of more mature data.

Additionally, through our partnerships, we have access to several candidates that could help modulate immunosuppressive and tumor permissive cell types and pathways, including <unk> checkpoint inhibitor, which recently expanded to a phase <unk> study and Johnson <unk> inhibitor, which received IND clearance last quarter.

Speaker from Gilead: We're also continuing our work to develop novel oral antivirals for the treatment of COVID-19. Moving to slide 18, we continue to view Trudelvie as a pipeline in a product. Trudelevy targets stroke two, which is overexpressed in many solid tumor cells.

Other potential opt in programs from partners include pioneers trend, one and <unk> two antibodies, which are in phase one trials and actively enrolling patients and a genesis CD 137 agonist, which is expected to be evaluated in the combination trial that will be initiated later this year.

In closing on slide 22, our teams are focused on executing across our oncology virology in inflammation pipeline.

Speaker from Gilead: So we believe that Trudelvey can have a meaningful impact on a wide range of cancers in addition to the second-line metastatic TNBC and second-line bladder indications that are approved today. We're all eagerly anticipating the readout from the Phase 3 Tropics 2 study, our randomized phase three trial in HR positive, PD two negative metastatic breast cancer. As a reminder, this is an event-driven trial evaluating disease progression, and we have not yet achieved the target number of events. As such, we now expect to have the top-line data read out in late January or early February. To be clear, data analysis will only begin once we achieve the required number of events.

It's still early days for our inflammation portfolio remained committed and invested in continuing to advance our pipeline across various mechanisms of action such as Iraq for Alpha four beta seven and tipple too.

In combination with our Aten partners, our pipeline portfolio spans many of the most promising targets across our three therapeutic focus areas, we're excited and committed to build out our best in class and industry leading franchises.

Now I'll hand, it over to Andy.

Thank you <unk> and good afternoon, everyone.

Moving to slide 24, as you have heard from Joanna our financial performance in the third quarter overall was strong with total product sales up 13% year over year, driven by <unk> continued role in the pandemic.

Year over year total product sales, excluding VAT glory fell 3% due to lower truvada at a triple sales following their loss of exclusivity late last year.

Offset in part by the continued demand for <unk> and contributions from our new medicines such as <unk>.

Speaker from Gilead: We remain confident in the potential of Trudelevy to deliver a clinically meaningful benefit to patients with HR positive per two negative metastatic breast cancer. We also continue to advance Tridelvey into registrational studies for other indications. For example, as recently posted on Clintrials.gov, we plan to initiate the phase three trial in second to third line non-small lung cancer at risk and look forward to sharing updates for other solid tumors as we expand the program.

Sequentially total product sales, excluding <unk> were up 2% highlighting the ongoing pandemic recovery in HIV treatment and prep.

This was partially offset by HCV, where new starts in both the U S and Europe continued to be impacted by the pandemic.

Turning to the rest of the P&L.

Non-GAAP product gross margin was 90% 350 basis points higher year over year, reflecting the reversal of a previously recorded $175 million litigation reserve as well as lower royalty expense and a change in product mix.

Non-GAAP R&D was $1 1 billion down 4% year over year, reflecting lower Ram that severe inflammation related expenses offset in part by increased clinical investment and Trudeau V and the gorilla map.

Non-GAAP SG&A was $1 2 billion up 8% year over year, driven by increased promotional and marketing activities across all of our geographies primarily forward should lv.

Speaker from Gilead: As Dan mentioned, we'll also start to work with Merck on a new clinical study looking at Trudelvey in combination with Merck's K. Trudeau for first-line metastatic TMBC and plan to initiate the trial in the first half of 2021. Moving on to slide 19, we continue to believe that with its synergistic potential and the safety profile observed to date, Marrylamab could benefit patients with a variety of hem As you know, our initial focus has been MDS and AMN.

On tax we realized a higher effective tax rate of 18, 9% for the third quarter were up 50 basis points year over year, primarily due to a prior year net discrete tax benefit.

Overall, our non-GAAP diluted earnings per share was $2 65 for the quarter compared to $2 11 for the same period last year the year over year increase primarily reflects higher victory sales and product gross margin offset by higher SG&A lower interest income and higher effective tax rate.

On Slide 25, you can see that in fact, Larry has already exceeded our prior guidance for the year with total revenues of $4 2 billion in the first nine months.

As a result, and with modestly updated expectations for the rest of our business. We are increasing our revenue and earnings per share guidance for the full year by 6% and 13% at the midpoint, respectively as shown on slide 26.

Speaker from Gilead: While our commitment to these patients remains unchanged, we continue to evolve our clinical programs in the context of recent developments in the MDS therapeutic landscape. The ongoing phase three enhanced trial evaluating Magrolumab and higher-risk MDS is on track and enrolling well. We will discuss our development plans and regulatory path forward with the FDA before the end of the year. Meanwhile, the data from our Phase 1B trial continues to mature, and we now expect to share top-line data in the first quarter of 2021.

After the wave of infections and hospitalizations in recent months. We believe we have moved past the peak of the pandemic for the year.

We continue to expect that <unk> will play an important role in the treatment of patients with COVID-19 globally. However, assuming we do not experience. Another surge we expect victory revenue to step down significantly in the fourth quarter.

As a result, we are raising our full year total product sales in the range of 26% to $26 3 billion compared to our previous range of 24, 4% to 25 billion, reflecting results year to date and regulatory performance.

We now expect full year <unk> revenues to be in the range of four five to $4 8 billion up from our prior outlook of $2 7 million $3 1 billion.

We continue to expect that sales in February will track COVID-19 related hospitalizations.

We now expect full year total product sales, excluding <unk> to be approximately $21 5 billion compared to the prior range of 21, 7% to $21 9 billion, reflecting our performance year to date and continued pandemic related impact.

Speaker from Gilead: Looking beyond MDS, our enhanced two trial from Grolam-Abb in first-line TP53 mutant AML is ongoing, targeting a new therapeutic option for nearly 2,000 patients in the U.S. In addition, an estimated 6,000 patients in the U.S. are diagnosed and treated annually with unfit AML.

As for the rest of our P&L, we expect our non-GAAP product gross margin to be approximately 87% compared to 86% to 87% previously primarily reflecting the strong gross margin in the third quarter.

For non-GAAP operating expenses, we now expect R&D to decline mid single digit percentage compared to 2020 levels as compared to our prior expectations of low to mid single digit percentage decline.

Speaker from Gilead: So we're expanding our development efforts to initiate a phase three trial for first-line unfit AML by early next year. In the past few months, we've initiated two solid tumor trials for Magrolomab, one in head and neck cancer and a separate solid tumor basket study for patients with non-small cell lung cancer, small cell lung cancer, and urethelial cancer. We also plan to initiate a third study in metastatic TMBC based on broad CD-47 expression. We're excited by mygrolamab's potential to be an effective therapy for solid tumors, and look forward to sharing more updates as they become available.

We expect SG&A to be flat on a dollar basis compared to 2020 versus prior expectations of flat to low single digit percentage decline.

On our non-GAAP effective tax rate is still expected to be approximately 21% this year.

Finally, with the updates to our revenue product gross margin and operating expenses. We now expect our non-GAAP diluted EPS to be between $7 90, and $8 <unk> for the full year and GAAP diluted EPS to be between $5 50, and $5 77.

On capital allocation, our priorities have not changed we continue to invest in our business and at the same time, we've returned over $1 billion in the third quarter and $3 2 billion year to date to our shareholders through both dividends and share repurchases.

We have also repaid $3 75 billion in debt this year and earlier today, we notified our three non call one bondholders that we would exercise our ability to repay $1 billion of the notes early.

Taken together, we now expect to pay down $4 $75 billion of debt this year significantly exceeding our prior guidance to pay down at least $4 billion.

Speaker from Gilead: Next, on behalf of Christy and the kite team, I also wanted to highlight the most recent approval for Takardas and adults with relapsed or refractory ALL on slide 20. There is an incredibly high unmet need for these patients, with 50% of adult patients relapsing on currently available treatments. The approval was based on data from Zuma 3, which demonstrated that 65% of patients achieved complete remission. Additionally, as Joanna mentioned earlier, Kite has filed the SBLA for Yes Garda and Second Line LBCL.

With that I'll invite the operator to begin the Q&A.

Yes.

Thank you as a reminder to ask a question you need to press star one on your telephone to withdraw your question press. The pound key we ask that you. Please limit yourself to one question.

Then your line will be muted if you have a follow up please re queue. Our first question comes from Matthew Harrison with Morgan Stanley. Your line is open.

Great. Good afternoon. Thanks for taking the question probably unsurprisingly my questions from our Dad. My Dad can you just comment maybe in a little bit more detail in terms of.

The assumptions that you've previously made on tropics too and how they were tracking are not tracking that caused you to make this change and especially around the.

Speaker from Gilead: With the medium follow-up of two years, the study meant the primary endpoint of event-pre-survival with a hazard ratio of 0.398 and a P-value of less than.000001, representing a potential significant advance in the standard of care for LVCL patients.

The blinded event rate and anything else you were watching in the trial.

Hi, Matthew sure happy to.

Yes look I think as you know event driven trials are inherently.

Variable in terms of when the events occur and importantly windows events come into the database. So we had initially thought we would hit the mark.

Speaker from Gilead: We look forward to reviewing the entire dataset at Ash and expect an update on approval next year. Lastly, moving to slide 21, we remain very excited about our oncology partners, whose work spans many promising new pathways in oncology. For example, our partners, ARCIS, have a pipeline that includes not only antitumic candidates but also CD-73 and addenicing receptor inhibitors to promote immune responses and inhibit tumor growth. We continue to expect to trigger the opt-in review period for Arcus's Domumav, likely later this year or early next year, pending the review of more mature data.

This year, but as time has gone by our best projections right now is that we'll hit that mark.

Next year and as we said I think we will be able to share those results probably.

Mid January to mid February timeframe, so that's kind of how we're tracking to the events at this point.

Catherine I think we're ready for our next call.

Our next question comes from Tyler Van Buren with Cowen Your line is open.

Hey, guys. Good afternoon. Thanks for taking the question I have another one on tropics <unk> can you just remind us or help set expectations in terms of what you feel is a clinically meaningful benefit on PFS.

A lot of people seem to be taking it up around two months, if you do reach that.

Two month PFS benefits, a one 6% one seven would you guys still go ahead and file.

Speaker from Gilead: Additionally, through our partnerships, we have access to several candidates that could help modulate immunosuppressive and tumor permissive cell types and pathways, including Tizona's HLIG checkpoint inhibitor, which recently expanded to a Phase 1B study, and Jounce's CCR8 inhibitor, which received I and D clearance last quarter. Other potential opt-in programs from partners include Pioneers, Trem 1, and Trem2 antibodies, which are in phase one trials and actively enrolling patients, and A Genesis CD-137 agonist, which is expected to be evaluated in a combination trial that would be initiated later this year. In closing, on slide 22, our teams are focused on executing across our oncology, virology, and inflammation pipeline.

Or how would you view the data thank you.

Thanks Tyler.

Yes, Tyler thanks, yes.

I do think the consensus that folks have seen we would agree that.

Two months is sort of that.

That threshold for clinically meaningful.

I think if we if we were to fall short of that.

<unk>.

<unk> is a difficult place to speculate and not our expectation, but if that were to happen. We would look at the totality of the data.

Wanted to look and see if there is a.

Other areas, where we could provide benefit to patients and we look at the totality of the data before deciding what we would do.

Thank you our next question comes from.

Well my response with Evercore.

Your line is open.

Speaker from Gilead: And while it's still early days for our inflammation portfolio, we remain committed and invested in continuing to advance our pipeline across various mechanisms of action, such as IRAC 4, Alpha 4, Beta, 7, and Tipple 2. In combination with our opt-in partners, our pipeline portfolio spans many of the most promising targets across our three therapeutic focus areas. We're excited and committed to building out our best in class and industry-leading franchise. I have now handed over to Ann.

Hi, maybe let me focus on the room death severe for a quick second Andy.

Jamie Joanna.

I'm just trying to understand the reported number a little better it's $1 billion five in the U S. In third quarter, which if you sort of re express based on the room that severe price point would imply maybe 750000 patients on the drug.

Third quarter in the U S and we know the total U S. Covid hospitalizations were right around 750000 in U S as well.

Is it just a reporting artifact and HHS estimates.

Speaker from Gilead: Thank you, Murad, and good afternoon, everyone. Moving to slide 24. As you've heard from Joanna, our financial performance in the third quarter was overall strong, with total product sales up 13% year over year, driven by Veclure's continued role in the pandemic. Year over year, total product sales excluding Veclary fell 3% due to lower Truvada and A-Triple sales following their loss of exclusivity late last year, offset in part by the continued demand for Bictarvi and contributions from our new medicines such as Tridelvey.

I'm just trying to understand why this was materially different than the 50% to 60% penetration, but I'm desperate historically had.

And I'll spare my tropics question from you that subsequent to the call.

Thanks, Thanks, Steven go.

Go ahead.

Sure Hey, Omar.

I think what so the $9 million that Dan referred to earlier is really a mix over the year right. So that's a little bit different than what you are referring to the $1 5 billion and you asked most of the sales actually of the total $1 nine.

Coming out of the U S and the patient population, so I can't track your math per.

Speaker from Gilead: Sequentially, total product sales excluding Veclory were up 2%, highlighting the ongoing pandemic recovery and HIV treatment and PrEP. However, this was partially offset by HV, where news starts in both the U.S. and Europe continue to be impacted by the pandemic.

But what I would say is.

That the U S patient population with the greatest and if you just do the math on about a five day therapy or an average price per gram guys. Here that you would get to less than $750 getting it off the top of my head. So I think it's probably a little bit lower than that and higher in other parts of the world just because of price.

Speaker from Gilead: Turning to the rest of the P&L, non-Gap product gross margin was 90%, 350 basis points higher year over year, reflecting the reversal of a previously recorded $175 million litigation reserve, as well as lower royalty expense and a change in product mix. Non-Gap R&D was $1.1 billion, down 4% year over year, reflecting lower remdesivir and inflammation-related expenses, offset in part by increased clinical investment in Trudelevy and Magrolama. Non-Gap SGNA was 1.2 billion, up 8% year over year, driven by increased promotional and marketing activities across all of our geographies, primarily for Trudelevy.

And Joanna the.

Maybe also to cope with numerous question that occurred.

Market share of patient per patient yes.

A little bit north of 60% that you're referring to we've seen obviously, we're looking at different databases, but we've seen up to close to 66% 67% of share of that glory in early days of hospitalization, obviously, often used with dexamethasone and other.

In prime product that anti inflammatory products, but we do see the share increasingly seen that obviously with the surge in August and September we saw that.

Both from a protocol standpoint as well.

Let's play out in the usage itself in the U S. Specifically.

Speaker from Gilead: On tax, we realized a higher effective tax rate of 18.9% for the third quarter; we're up 50 basis points year over year, primarily due to a prior year net discrete tax benefit. Overall, our non-gap diluted earnings per share was $2.65 for the quarter compared to $2.11 for the same period last year.

Thanks.

Thank you. Our next question comes from Brian Abrahams with RBC capital markets. Your line is open.

Hey, guys. Thanks for taking my question sticking.

Sticking with Covid I'm curious to learn more about your outlook on how COVID-19 treatment will evolve into next year and beyond and I am curious if you could give us a little bit more color around the efforts to develop oral direct acting antivirals for COVID-19.

Speaker from Gilead: The year-over-year increase primarily reflects higher Veclure sales and product gross margin, offset by higher SGNA, lower interest income, and higher effective tax. On slide 25, you can see that Veclure has already exceeded our prior guidance for the year, with total revenues of $4.2 billion in the first nine months. As a result, and with modestly updated expectations for the rest of our business, we are increasing our revenue and earnings per share guidance for the full year by 6 and 13% at the midpoint, respectively, as shown on slide 26.

Spoke about at the beginning of the call are these primarily.

That's severe derivatives youre looking at protease inhibitors potential combination cocktails when might we learn more about those.

Yes, Thanks, Brian I think we've all been a little bit shy about predicting how the.

We will continue to evolve because I think we've proven to be.

Not always right.

Mark.

Dad comment and also have the other team members have anything to comment, but I will say is back to the previous question from Emera Theres no doubt that we see a direct connection correlation between <unk> use an outbreak. So that continues and is joining us as we continue to get the market share and there is also no doubt Brian to your point.

Though.

Speaker from Gilead: After the wave of infections and hospitalizations in recent months, we believe we have moved past the peak of the pandemic for the year. We continue to expect that Veclory will play an important role in the treatment of patients with COVID-19 globally.

Injectable Rendez Servier continues to play a really important role around the world for hospitalized patients and now the data obviously, we have in the outpatient setting.

We're not satisfied yet however, you want to continue to put our science to work and maybe Murdo.

Or that if you wanted to if you want to have any forecast in the future a pandemic environment Youre welcome too.

Thank you.

No I agree with Dan I think it's incredibly difficult to.

To predict outside of I think what we're all starting to believe is that it'll be a combination of vaccines therapeutics of various.

Speaker from Gilead: However, assuming we do not experience another surge, we expect Veclory revenue to step down significantly in the fourth quarter. As a result, we are raising our full year total product sales in the range of 26 to 26.3 billion compared to our previous range of 24.4 to 25 billion, reflecting results year to date and Veclary performance. We now expect full-year Veclure revenues to be in the range of 4.5 to 4.8 billion, up from our prior outlook of 2.7 to 3.1 billion. We continue to expect the sales of Veclory will track COVID-19 related hospitalizations.

Types.

Of course.

Anticipating.

Changes in the virus over time.

We'll have to keep an eye on it and see how it goes importantly to date, none of the variance have shown any resistance to <unk>. So we think that's.

A positive.

Outcomes, so far we haven't disclosed yet what the what the oral compounds are going to be there. We are moving them forward as quickly as possible and we will share those data as those molecules begin to mature.

But our hope is that they certainly provide an alternative treatment option in particular in the outpatient setting.

Speaker from Gilead: We now expect full-year total product sales excluding Veclary to be approximately $21.5 billion, compared to the prior range of $21.7 to $21.9 billion, reflecting our performance year-to-date and continued pandemic-related impact. As for the rest of our P&L, we expect our non-gap product gross margin to be approximately 87% compared to 86 to 87% previously, primarily reflecting the strong gross margin in the third quarter. For non-gap operating expenses, we now expect R&D to decline by a mid-single-digit percentage compared to 2020 levels, as compared to our prior expectations of a low to mid-single-digit percentage decline.

With the glory remaining.

Really the stalwart.

Hospitalized and potentially the outpatient IV setting.

And I would just add Brian I think it's fair to say that obviously, we continue to work on an oral versions of <unk> as we've said before in the past and to your point I mean.

From a scientific standpoint, the opportunity to look at combination therapy in oral medicines for Covid.

Also anticipate future viral.

Resistance. So those are all themes and then.

But at this point, we will of course be updating you as those.

As those medicines continue to move forward.

Thanks, Brian.

Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open.

Speaker from Gilead: We expect SG&A to be flat on a dollar basis compared to 2020 versus prior expectations of a flat to low single-digit percentage decline. Our non-gap effective tax rate is still expected to be approximately 21% this year. Finally, with the updates to our revenue, product gross margin, and operating expenses, we now expect our non-Gap diluted EPS to be between $7.90 and $8.10 for the full year, and Gap diluted EPS to be between $5.50 and $5.70. As for capital allocation, our priorities have not changed.

Afternoon, guys. Thanks, so much for the question.

Just had a bigger picture question on HIV.

When you look in the pandemic from desk severe has done quite well, even this quarter and in your oncology pipeline has really grown but when you look at the core HIV business long term great long term growth rate, we used to think was high single digits.

Is much lower last year than this year and I know you have generics and I know the pandemic has affected the market, but the question is do you think you'll go back to a higher long term growth rate in HIV and maybe just help us with the with.

With the drivers of that thank you very much. Thank.

Thank you, Jeff So Joanna sure Jeff are you asking specific to the market or just generally.

Speaker from Gilead: We continue to invest in our business, and at the same time, we've returned over $1 billion in the third quarter and $3.2 billion year to date to our shareholders through both dividends and share repurchases. We have also repaid $3.75 billion in debt this year, and earlier today, we notified our three non-call-one bondholders that we would exercise our ability to repay $1 billion of the notes early. Taken together, we now expect to pay down $4.75 billion of debt this year, significantly exceeding our prior guidance to pay down at least $4 billion. With that, I'll invite the operator to begin the Q&A.

For you guys maybe answer the market okay.

So I think what we said in the second quarter was exactly kind of what's playing out today. So we have seen a little bit of a recovery in Q2, and we're seeing that recovery continue Ashley and accelerate a little bit into Q3. So we're at about 3% growth. We were at about 2% in Q2, and we were negative three quarters before that.

Where the what we're assuming at this point is actually we are going to get back from a market standpoint back to where we were prior to Covid. We're just starting from a much lower base. So its going to take a little bit of time. So I think the assumption is that as we get to 2022, you'll see that kind of play out assuming no other major searches come through.

So that from a market standpoint, which obviously will help from that.

Operator: Thank you. As a reminder, to ask a question, you need to press star 1 on your telephone. To withdraw your question, press the pound key. We ask that you limit yourself to one question. Then your line will be muted. If you have a follow-up, please re-cue. Our first question comes from Matthew Harrison on behalf of Morgan Stanley. Your line is open.

From a product standpoint.

When you think about baked Harvey and you think about our growth year on year at about 20% and then of course double digit growth on a quarterly basis as well.

We have different dynamics going on obviously demand is still strong. So we're quite pleased with that we grew about one 5% share over the last quarter over 6% and a full year.

Matthew Harrison: Great, good afternoon, thanks for taking the question, and probably unsurprisingly, my questions for Murad. Murad, could you just comment maybe in a little bit more detail in terms of the assumptions that you previously made on Tropics 2 and how they were tracking or not tracking that caused you to make this change, and especially around the blinded event rate and anything else you were watching in the trial. Thanks. Hi Matthew, sure, happy to. Yeah, look, I think so.

So we're on a much larger base because we are market leader, but we've also had some different pricing dynamics as well going on that.

That are related to obviously the mix that we're looking at so so that's something that that has impacted directly by the pandemic right. As you think about your government versus commercial mix and we've seen ph phs channels, specifically kind of grow a little bit more rapidly than any other segment over the last couple of quarters. So those are kind of the dynamics that we're dealing with but if you look at the basic demand.

Merdad V. Parsey: Hi Matthew, sure, happy to. Yeah, look, I think, as you know, event-driven trials are inherently variable in terms of when the events occur and, importantly, when those events are entered into the database. So we initially thought we would hit the mark this year, but as time has gone by, our best projections right now are that we'll hit that mark next year. And as we said, I think we'll be able to share those results, probably in the mid-January to mid-February timeframe. So that's kind of how we're tracking to the event.

<unk> very strong in double digit growth.

Jeff It's probably for Andy It's also probably worth highlighting again the difference in the prep market in the treatment market. So I think as John touched based on the treatment market. That's exactly right remember that a lot of the growth that you are referring to a couple of years ago was driven by the incredibly strong prep market as well. We think you will see that again, it's just going to take the introduction of <unk>.

A year and a couple of years to get there. So the dynamic in the treatment market I think is relatively constant with what we've seen historically, it's just we're building off a bigger base as John has said and the market will continue to grow and then you should see the dynamic coming back in a couple of years in terms of driving additional growth.

Thanks, Jeff.

Thank you. Our next question comes from Michael Yee with Jefferies. Your line is open.

Tyler Van Buren: Our next question comes from Tyler Van Buren with Cowan. Your line is open. Hey guys.

Oh, Hey, good afternoon. Thanks for the question sorry to go back to the tropics too, but I do think it's important I don't wanted to ask <unk>. What is your view was on the importance of OS.

Tyler Van Buren: Hey guys, good afternoon. Thanks for taking the question. I have another one on Tropics Zero2.

Obviously with the immature in I think math would suggest you could get OS later in 'twenty, two but if you do have a PFS benefit around two months, how confident are you that you'd still be okay and confident around OFC hitting.

Tyler Van Buren: Can you just remind us or help set expectations in terms of what you feel is a clinically meaningful benefit on PFS? You know, a lot of people seem to be pegging it at around two months. If you do reach stats at a sub-two-month PFS benefit, say, 1.6 or 1.7, would you guys still go ahead and file, or how would you view the data?

And cross sell for another impact Wouldnt impede that Vishal, maybe just comment on that a bit. Thank you.

Sure Michael happy to yeah.

Look I think as you recall one of the reasons we.

Modify the study just important to go back to the early part of the year when we modified this trial.

Merdad V. Parsey: Thank you. Thanks, Tyler. Yeah, Mernad. Yeah, Tyler, thanks.

We expanded the sample size and we.

Merdad V. Parsey: Yeah, we, I do think the consensus that folks have seen is that, you know, two months is sort of that threshold for clinically meaningful. You know, I think if we were to fall short of that, which is a difficult place to speculate and not our expectations, but if that were to happen, we would look at the totality of the data. We'd want to look and see if there are other areas where we could provide benefit to patients, and we'd look at the totality of the data before deciding what we do.

Change the endpoint and.

I think the.

Purpose behind modifying the sample size was to make sure that we could hit OS with the assumptions that we had in the trials. So.

I think if we hit PFS.

We feel reasonably confident with all the caveats that you said around crossover and things like that that are more difficult to control.

That we should be able to hit OS.

So.

I think that's important and I think that really gets too.

The other underlying issue around this delay right as we moved from.

Speaker from Gilead: Hi, maybe let me focus on Remdesivir for a quick second. Andy, Joanna, I'm just trying to understand the reported number a little better. It's a billion five in the U.S. and third quarter, which if you sort of re-express based on the Remedesivir price point, would imply maybe 750,000 patients on the drug in the third quarter in the US. And we know the total US COVID hospitalizations were right around 750,000 in the US as well. Is it just a reporting artifact in HHS estimates?

Investigator to central overrides of the.

Of the progression events those are the things that sort of led to the slight delay here that we're talking about but I think that all means we will have a stronger outcome when the data are available.

And maybe just at the risk because I know there has been several questions.

Just to complement what murdo.

When we think about trials in the oncology space for all of us have a lot of experience.

Certainly not uncommon when you when you think about event driven trials to have.

These slight adjustments to timelines and I would just point out that I mean, initially we anticipated that we would have this data and turn data point with all the protocol adjustments that we did in the middle of the year in December of this year and now we're talking about those data coming in mid January to mid February so.

Speaker from Gilead: to understand why this was materially different from the 50 to where it's historically been, and I'll spare you my tropics question from your dad subsequent to the call. Thanks, Eamor. Go ahead, Joanie, you want to hit that one? Sure, hey, Omer.

The timeline changes is really.

Very minor.

Speaker from Gilead: I think what the 9 million that Dan referred to earlier is really a mix over the year, right? So that's a little bit different than what you're referring to. The $1.5 billion in the U.S.; most of the sales actually have the total 1.9, obviously, coming out of the U.S. and the patient population. So I can't track your math, per se, but what I would say is that the U.S. patient population was the greatest, and if you just do the math on about a five-day therapy at an average price for Remdesivir, you would get to less than 750, just doing it off the top of my head.

And in terms of the trial conduct design.

Nothing has changed in regards to our confidence for tropics too. So I just wanted to.

To make sure I also had a chance to say that thanks, Mike.

Our next question comes from Corey CASM.

Okay.

With Jpmorgan your line is open.

Hi, Good afternoon, guys. Thanks for taking my question I guess I wanted to ask you about the ARCUS ticket program and with regard to the added data you expect to get on this asset to make that go no go decision is it is it just more durability or you're going to see more patients to basically just looking for your latest thoughts there on what it would take for you to opt in thank you.

Speaker from Gilead: So I think it's probably a little bit lower than that and higher in other parts of the world just because of price points. And, Joanna, maybe also to compliment you on your question: the current market share of patients. For patients. Yeah, so it's probably a little bit higher.

Over to you, yes sure.

Thanks Corey.

We do anticipate that the data will mature I think is what we've what we've been saying and I think thats a combination of things right more patients.

More patients per arm as well as.

Longer observation time for the patients that are.

Enrolled in this study.

So.

Brian Abrahams: Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is open.

We remain.

Really interested in that and.

Enthusiastic about that study and as I said I think we.

We feel that it's likely that we'll be able to make our opt in decision this year. So.

Speaker from Gilead: Hey guys, thanks for taking my question. Sticking with COVID, I'm curious to learn more about your outlook on how COVID treatment will evolve in the next year and beyond. And I'm curious if we can give us a little bit more color around the efforts to develop oral, direct acting antivirals for COVID that you spoke about at the beginning of the call. These primarily rmdesivir derivatives, you're looking at protease inhibitors, potential combination cocktails.

We continue to believe that Thats, where were headed with those data.

So in total I think we'll.

We do expect to see a larger.

The more robust data set to make a decision on and as we said before what we're looking for is clear separation of the doublet from single agent and we're looking for an <unk> of over 50% in the.

And the doublet and hopefully in the triplet as well that would be upside for us.

Katherine we're ready for the next caller please.

Our next question comes from Andrew <unk> with Wolfe Research Your line is open.

Alright, Thanks for taking my question I, just have one on the HIV pipeline.

Speaker from Gilead: When might we learn more about those? Thanks. Yeah, thanks, Brian. I think, you know, we've all been a little bit shy about predicting how the pandemic will continue to evolve because I think we've proven to be not always right about that. I'm going to let Merdad comment and also see if the other team members have anything to comment. But what I will say, back to the previous question from Umer, is that there's no doubt that we see a direct correlation between Remdesivir's use and the outbreak. So that continues, and as Joanna says, we continue to get market share.

So given you're collaborating with Merck online.

<unk> combo one of your competitors in this space claim that frontline standard of care needs to include an integration inhibitor. So given your experience with the big Tegra <unk> do you agree or not that an integrated inhibitor as always likely to be needed in a first line setting.

Yes.

Thanks for the question.

It's an interesting.

Yeah.

The statement to make we obviously don't believe that that's why we're pursuing.

The combination approach that we are.

So I think the data will tell the story in the long run we're pretty confident that that we can get there with the combination approach that we're taking right now.

Speaker from Gilead: And there's also no doubt, Brian, to your point, that although injectable remdesivir continues to play a really important role around the world for hospitalized patients, and now the data, obviously, we have in the outpatient setting, we're not satisfied yet. We want to continue to put our science to work. And maybe, Murad, if you want to have any forecasts for the future of the pandemic to endemic, you're welcome to. No, no, thank you.

Thanks, Sandra Alright, Catherine our next call.

Our next question comes from Geoffrey Porges with SBB Leerink. Your line is open.

Thank you very much for taking my question.

So wanted to go back to the Covid impairment question for the core business, perhaps you could give us a sense of where youre starts for HCV and HIV.

In Q4 compared.

Compared to Q4, 2019, and then secondarily.

Do you expect those businesses to grow in 2022, I know, it's early for guidance, but you've obviously developed your plan already.

Speaker from Gilead: No, I agree with Dan. I think it's incredibly difficult to. to predict outside of, I think, what we're all starting to believe is that it'll be a combination of vaccines and therapeutics of various types. Of course, anticipating changes in the virus over time, we'll have to keep an eye on it and see how it goes. Importantly, to date, none of the variants have shown any resistance to remdesivir, so we think that's a positive outcome so far.

So it would just be helpful to us.

How youre thinking about COVID-19 impact on those core businesses.

Jeff can I just clarify you made Q3 to Q3.

Where in Q4 now.

What are you trying to get a sense of.

You showed pretty clearly the decline in hospitalizations.

Number of different therapeutic categories were recovering in Q4, so really wondering where we are today compared to Q4 2019.

Sure, Let me start Jeff with HBV, and then I'll move on to HIV.

Speaker from Gilead: We haven't disclosed yet what the oral compounds are going to be, but we are moving them forward as quickly as possible, and we'll share those data as those molecules begin to mature. But our hope is that they certainly provide an alternative treatment option, in particular in the outpatient setting, with the glory remaining really a stalwart in the hospitalized and potentially the outpatient IV setting. I think, uh, And I would just add, Brian, I think it's fair to say that obviously we continue to work on oral versions of Rundesvier, as we've said before in the past, and to your point, I mean, So those are all themes. And then, to Merdad's point, we will, of course, be updating you on these. as those medicines continue to move forward,

So from an HBV standpoint.

We talked about being about 8%.

Under year.

Year over year, a lot of that has to do with timing and pricing adjustments. So it's not patient per se, we're actually flat pretty much year over year at 2% positive.

What we did see though is market starts declined in Q3, and that's directly related to the pandemic because less screening diagnosis. They were down again in Q3, and so we believe that will pick back up I wouldn't go so much to say that it will be.

An increase right, but I would say that we should be able to hold flat could you.

Typically see HCV patient starts decline over time, just because there's less patients that need the cure.

But not as quickly as what we're seeing in the quarter. So we do think that will pick back up.

And so we would assume a little bit more tempered <expletive>.

Decline in 2022.

And the HIV piece of the puzzle, we still are seeing screening and diagnosis less than pre COVID-19. So we're seeing about screening 10% down versus 2019 and diagnosis are still 20% below 2019 levels. So as much as we're seeing recovery quarter over quarter and we're excited about that because that's in line.

Geoff Meacham: Thank you. Our next question comes from Jeff Meacham with Bank of America. Your line is open. Good afternoon.

Geoff Meacham: Afternoon, thanks so much for the question. I just had a bigger picture question on HIV. You know, when you look at the pandemic, Remdesivir has done quite well; even this quarter in your oncology pipeline has really grown. But when you look at the core HIV business, you know, the long-term growth rate, we used to think was high single digits, and it's much lower, you know, last year and this year, and I know you have generics, and I know the pandemic has affected the market Thank you very much. Thank you, Jeff. So, Joanna.

With what we had assumed we are still not back to the levels that were needed to be and so I would say that you are now growing from a lower base and it is kind of what we talked about in the last quarter, where the assumption was that it would come right back, but the dynamic marketing HIV, it's very small and it's going to take a little bit longer and therefore, we're just growing from a lower base and we do believe we will get back.

<unk> two.

Typical levels that a couple of single digit growth from a market standpoint. In 2022 is just going to take US a couple of quarters to get there. So hopefully that helped a little bit.

Perspective that helps a lot. Thank you.

Thanks, Jeff.

Katherine go ahead Nick.

Our next question comes from Robyn Colonoscopy, which was securities. Your line is open.

Speaker from Gilead: Jeff, are you asking specifically about the market or just generally? For you guys, maybe and for the market. Okay.

Hey, guys. Thanks for taking my question.

Just thinking big picture.

Your growth your long term growth I mean, obviously a lot of questions here on <unk>.

Speaker from Gilead: So I think what we said in the second quarter was exactly kind of what's playing out today. So we had seen a little bit of a recovery in Q2, and we were seeing that recovery continue, actually, and accelerate a little bit into Q3. So we're at about 3% growth. We were at about 2% in Q2, and we were negative in the three quarters before that. What we're assuming at this point is actually we're going to get back from a market standpoint back to where we were prior, but we're just starting from a much lower base. So it's going to take a little bit of time.

And thinking about the HIV business.

Two core areas that are very important for our long term growth can you talk about how.

Are your expectations for <unk> market opportunity has changed from your initial acquisition and if you don't see.

The data that you want to see from tropics too and how are you going to think about.

Your strategy for growing the business because it seems like that is core to the long term future of the company.

Speaker from Gilead: So I think the assumption is that as we get to 2022, you'll see that kind of play out, assuming no other major surges come through. So that's from a market standpoint, which it obviously will help from a product standpoint. When you think about Big Tarvey and you think about our growth year on year at about 20%, and then, of course, double-digit growth on a quarterly basis as well, we have different dynamics going on.

Right. Thanks, Robyn I'll have Andy start here, and certainly Hey, Robyn. Thanks for the question and Joe May want to weigh in as well.

I think there are a number of growth drivers. So if we just step back when you think about long term growth has been a number of questions. So just.

To paint the picture again, there are a number of growth drivers that we see driving we don't provide specific long term guidance, what we've said and we'll continue to say is that.

The HIV business, including the long acting collaboration that you mentioned for <unk> cell therapy.

And a number of the other programs essentially the ARCUS programs are expected to drive our long term growth in the short run we see a much more promising growth profile than we did historically so we think that we've done a lot to turn the company around and now.

Speaker from Gilead: Obviously, demand is still strong, so we're quite pleased with that. We grew about 1.5% of our share over the last quarter, and over 6% in a full year. So we're on a much larger base because we are the market leader, but we've also had some different pricing dynamics as well going on that are related to, obviously, the mix that we're looking at. So that's something that is impacted directly by the pandemic, right, as you think about your government versus commercial mix.

The growth profile is improving significantly from our perspective.

When you get to 'twenty four 'twenty five again, we've said, we see unexpected inflection in our growth profile is a lot of these programs that are currently in the clinic hopefully reach the commercialization, including a number of the <unk> programs.

On <unk>, specifically I think we continue to be very bullish on the prospects for Richard ELV overall, similar to where we were when we did the transaction. So youll remember we highlighted that there are a number of ways to win with <unk>.

Speaker from Gilead: And we've seen PHS channels specifically kind of grow a little bit more rapidly than any other segment over the last couple of quarters. So those are kind of the dynamics that we're dealing with. But if you look at the basic demand, very strong double-digit growth. Jeff, it's probably a...

When we acquired immunomedics the hormone receptor positive study was just one of those studies. Obviously, we're excited about the work that we're doing in lung cancer and other areas. So there is a much broader clinical development plan for <unk> and then the market probably fully appreciates today that the announcement with Merck earlier today is a good example of that that will give you a sense.

And where we're going and we expect to give you a much greater sense of that overall, so I think at a macro.

Speaker from Gilead: Jeff, it's probably, Andy, it's also probably worth highlighting, again, the difference in the prep market and the treatment market. So I think it's John who touched on the treatment market. That's exactly right.

Macro level before I ask John to comment I'd say, our expectations for <unk> have not changed we continue to be very enthusiastic about where we are and where we're going and there is lots of different ways for us to get there over time.

Yeah, no. Thanks, Andy I would just add I think we are we are pleased with where we're going with <unk> today in the short term, we still believe that theres a lot of growth opportunities specifically in the earlier line setting both across triple negative breast cancer as well as bladder cancer and so we're seeing those opportunities play out I think the guidelines are going to help us set up for success.

Speaker from Gilead: Remember that a lot of the growth that you're referring to a couple years ago was driven by the incredibly strong pre-school market as well. We think you will see that again. It's just going to take the introduction of Lenna Capavir in a couple of years to get there. So the dynamic in the treatment market, I think, is relatively constant with what we've seen historically. It's just we're building off a bigger base, as Joanna said, and the market will continue to grow, and then you should see the prep dynamic coming back in a couple of years in terms of driving additional growth.

Seth let alone setup for future pipeline studies, such as HR positive coming through hopefully.

And in a positive way is as you mentioned and that should just can expand our market opportunity even more so the only thing I would add to what Andy was saying is also on the HIV front. So not looking just at the oncology opportunities, but also from an HIV standpoint, we still believe that Harvey is foundational to our HIV opportunities. In addition to of course Atlantic.

Michael J. Yee: Thank you. Our next question comes from Michael Yee with Jeffries. Your line is open. Oh, hey, good.

Speaker from Gilead: Hi, good afternoon, thanks for the question. Sorry to go back to the tropics, too, but I do think it's important. I wanted to ask Murdad what his view was on the importance of OS. Obviously, it would be immature, and I think math would suggest you could get OS later in 22.

With that Mary that spoke to earlier. So we're excited about what we have going on there as well.

Thank you Robyn.

Our next question comes from Ronny Gal with Bernstein. Your line is open.

Good afternoon, and thank you for taking my questions.

Can I, just ask a little bit about the agreement.

Michael J. Yee: But if you do have a TFS benefit for around two months, how confident are you that you'd still be okay and confident around OS hitting, and that crossover and other impacts wouldn't impede that result? Maybe just comment on that a bit. I can. Sure, Michael, happy to. Yeah.

But a combination of two delving keytruda.

Thank you.

With economics that to an elevated can you talk a little bit about the.

Elements of the agreement and then one of your peers.

Agreement with <unk>.

With Mark on non small cell lung cancer and I was wondering are those types of amendments exclusive that is.

They can have another trop two ADC.

Well negative breast cancer, and you might partner with <unk> in lung cancer as well.

Merdad V. Parsey: Look, I think, as you recall, one of the reasons we modified this study. It's just important to go back to the early part of the year when we modified this trial. We expanded the sample size, and we changed the endpoint. And I think the main purpose behind modifying the sample size was to make sure that we could hit OS with the assumptions that we had in the trial. I think if we hit TFS, we feel, you know, reasonably confident with all the caveats that you said, right, around crossover and things like that that are more difficult to control that we should be able to hit OS.

Yes, Hi, Ronny, it's Andy Thank you for the question.

Relatively straightforward. This is a straightforward simple clinical collaborations Merck is providing for Dolby. They obviously had input on the study design.

Keytruda Im sorry, Keytruda <unk> study thank you.

Do not have any economics on <unk> as a result of the study, but they will enjoy hopefully the added benefits to keytruda on their end.

And these studies are not exclusive so they have the ability to do other studies in the same area with other.

With other agents, including other trop two antibodies and we have the ability to do studies with other PD one inhibitors as well.

And of course, we started in triple negative breast cancer, you're highlighting that there is another study they will do with another <unk> inhibitor in lung cancer that of course is an area that we're going to look at it as well so.

Merdad V. Parsey: So, you know, I think that's important, and I think that really gets to, you know, the other underlying issue around this delay, right? As we moved from investigator to central overreads of the, um, progression events, those are the things that sort of have led to, uh, the slight delay here that we're talking about. But I think that all means we'll have a stronger outcome when the data is And maybe just at the risk, because I know there have been several questions on O2, just to compliment what Murdad has said.

I expect that there is more to come but these are relatively straightforward and simple plain vanilla clinical collaborations.

And as part of our strategy right run into to scale the opportunity with <unk> because there's many things we can do ourselves, but frankly, given the multi tumor opportunity for turn of Lv.

Gauging and partnerships like this allows us to expand.

Much more than we put ourselves I think it is.

Beginning of what Youll Youll see from us as we look to.

Really.

Expand on that.

Merdad V. Parsey: I mean, when we think about trials in the oncology space, which all of us have a lot of experience with, it's certainly not common when you think about event-driven trials to have these slight adjustments to timelines. And I would just point out that, I mean, initially, we anticipated that we would have this data, and to Mardad's point, you know, with all the protocol adjustments that we did in the middle of the year, in December of this.

Promising potential to Adobe.

Catherine I think maybe we have time for two more questions.

Okay. Our next one comes from Brian <unk> with Baird. Your line is open.

Hey, good afternoon, everyone and thank you for taking my question I guess, it will be seen a bunch of potentially transformative data in large b cell lymphoma in a couple of months I assume at ash.

In addition to your own data just kind of thoughts on given the <unk> success. How do you think about the potential for <unk> to move upwards into the frontline setting and does the success of full EV actually change the market opportunity in your view for second line as well.

Merdad V. Parsey: And now we're talking about data coming in mid-January to mid-February. So, you know, the timeline change is really, you know, very minor. And in terms of the trial conduct and design, I mean, nothing has changed in regards to our confidence for the tropics, too. So I just wanted to, to make sure I also had a chance to say that. Thanks, Mike.

Thanks.

Christy please.

Sure. So yes, we're very excited about our submission at the end of September for second line and expect to hear back.

On the status from FDA first half of next year, but we will be presenting the data at ash as you said and.

Speaker from Gilead: Our next question comes from Corey. Catch them off guard with J.P. Morgan, your line is open.

Cart car T is really the only potential cure, we're seeing right now so when you look at the out of class second line agents and moving to frontline.

Corey Kasimov: Good afternoon, guys, thank you for taking

Speaker from Gilead: Good afternoon, guys. Thank you for taking my question. I guess I wanted to ask you about the Arcus Tidgett program.

Typically has been a delay to car T.

Speaker from Gilead: With regard to the added data you expect to get on this asset to make the go-no-go decision, is it just more durability? Are you going to see more patience in basically just looking for your latest thoughts there on what it would take for you to opt in? Thank you. Over to you, yeah, sure. Thanks, Corey.

And now with this new study coming out we'll have to see what that exact duration will be for those patients. We hope it'll be successful, but we don't see a huge impact to our projections and the cell therapy marketplace second line actually allows us to basically double the market that we can play in which is about 14000 page.

Speaker from Gilead: Yeah, we do anticipate that the data will mature, I think, is what we've been saying, and I think that's a combination of things, right? More patients, more patients per arm, as well as longer observation time for the patients that are enrolled in the study. So, we remain really interested in that and enthusiastic about that study. And, as I said, I think we feel that it's likely that we'll be able to make our opt-in decision this year.

<unk> in the U S.

That combined with you'll also see our frontline data Zuma 12, which was completed we'll be presenting that at ash as well so you'll see that our front line second line and see how it may stack up although theyre not head to head trial. So we're pretty confident in where we are and it doesn't really change our projections.

The future of cell therapy or for our specific brands.

So Katherine maybe just one last question please.

Our last question comes from Carter Gould with Barclays. Your line is open.

Great. Good afternoon. Thanks for squeezing me in maybe just one on the the lung study that's going to get started later this year for <unk> characterized characterized starting that study at risk.

Speaker from Gilead: So we continue to believe that that's where we're headed with these data. So in total, I think we'll, we do expect to see a larger, more robust data set to make a decision. And as we said before, what we're looking for is clear separation of the doublet from the single agent, and we're looking for an over R of over 50% in the doublet and, hopefully, in the triplet as well. But that would be up to

Presumably you've had some insight from from the basket study is that a fair assumption and can we see data from that basket study.

Maybe by the time, we see tropics two data thank you.

Thanks, Great question.

Our.

We're looking at the totality of the data we have it's not just the tropics III data, we're looking at the totality of the data in lung that we have.

Andrew Galler: Our next question comes from Andrew Galler with Wolf Research. Your line is open.

Accumulated and Thats really the.

The approach we're taking so.

Speaker from Gilead: Hi, thanks for taking my question, and I just have one on the HIV pipeline. So, given you're collaborating with Merck on the Elena Capovir and a slaps reviewer combo, one of your competitors in this space claimed that the frontline standard of care needs to include an integration inhibitor. So given your experience with the Big Tegravier, do you agree or not that an integration inhibitor is always likely to be needed in a first-line setting? Yeah, thanks for the question.

I take your point and it's.

Arguably not that bigger risks given given the data we've seen.

We I would not expect for us to be sharing those data around the time of the tropics too, but we do we will plan on sharing those data.

So we'll definitely share those data over time.

For now we're pretty excited by what we've seen in terms of the daily performance in non small cell.

Thanks, Kevin.

Speaker from Gilead: It's an interesting statement to make; we obviously don't believe that. That's why we're pursuing the combination approach that we are. So I think the data will tell the story in the long run. We're pretty confident that we can get there with the combination approach that we're taking right now.

That's all the time, we have for question I would like to turn the call back to Jacquie Ross for closing remarks.

Thank you Catherine and thank you all for joining US today. We appreciate your continued interest in Gilead and look forward to updating you on our progress.

Jeffrey Porges: Our next question comes from Jeffrey Porges with SVB Lairink. Your line is open. Thank you very much for taking the question.

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

Jeffrey Porges: So I want to go back to the COVID impairment question for the core business. Perhaps you could give us a sense of where your start is for HCV and HIV in Q4 compared to Q4 2019. And then secondarily, do you expect those businesses to grow in 2022? I know it's early for guidance, but you've obviously developed your plan already, so it would be helpful to see how you're thinking about COVID's impact on those core businesses.

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Okay.

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Speaker from Gilead: Jeff, can I just clarify that you made it to Q3? No, we're in Q4 now, and I'm really trying to get a sense of, you know, you showed pretty clearly the decline in hospitalizations and a number of different therapeutic categories we're recovering in Q4. So really wondering where we are today compared to Q4-29. Gotcha, Joanna.

Yes.

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Speaker from Gilead: Sure, let me start, Jeff, with HCV, and then I'll move on to HIV. So from an HCV standpoint, we talked about being about 8% under year over year. A lot of that has to do with timing and pricing adjustments, so it's not patient per se. We're actually flat pretty much year over year, about 2% positive. What we did see, though, is that market starts declined in Q3, and that's directly related to the pandemic, because less screening diagnosis, they were down again in Q3. And so we believe that they'll pick back up.

Speaker from Gilead: I wouldn't go so much as say that there will be an increase, right? But I would say that we should be able to hold flat because you typically see HD patients start to decline over time just because there are less patients that need the cure, but not as quickly as what we're seeing in the quarters. So we do think that'll pick back up. And so we would assume a little bit more temperament.

Speaker from Gilead: decline in 2022. The HIV piece of the puzzle; we still are seeing screenings and diagnosis less than before COVID-19. So we're seeing screenings 10% down versus 2019, and diagnoses are still 20% below 2019 levels. So as much as we're seeing recovery quarter over quarter, and we're excited about that because that's in line with what we had assumed, we're still not back to the levels that we were needed to be. And so I would say that you're now growing from a lower base.

Speaker from Gilead: And it's kind of what we talked about in the last quarter, where the assumption was it would come right back. But the dynamic market for H-I.D. is very small, and it's going to take a little bit longer. And therefore, we're just growing from a lower base, and we do believe we'll get back to typical levels of a couple of single-digit growth from a market standpoint in 2022. It's just going to take us a couple of quarters to get back.

Speaker from Gilead: So hopefully that helps a little bit, gives you perspective. That helps a lot. Thank you.

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Robin Karnauskas: Our next question comes from Robin Karnas, who says, with Securities, your line is open. Hi, guys, thanks for taking my question.

Speaker from Gilead: Just thinking big picture about your growth, your long-term growth. I mean, obviously, I have a lot of questions here about Traveldi and thinking about the HIV business as two core areas that are very important for your long-term growth. Can you talk about how your expectations of Traveldi's market opportunity have changed from your initial acquisition?

Speaker from Gilead: and If you don't see the data that you want to see,

Speaker from Gilead: to see from Trophics too, how are you going to think about your strategy for growing the business? Because it seems like that is core to the long-term future of the company. Right, thanks, Robin. I'll have Andy start here, and certainly, yeah.

Speaker from Gilead: Hey, Robin, thanks for the question, and Joanna may want to weigh in as well. Look, I think there are a number of growth drivers. So if we just step back, when you think about long-term growth, there are a number of questions. So just to paint the picture, again, there are a number of growth drivers that we see driving growth. We don't provide specific long-term guidance. What we've said, and we'll continue to say, is that the HIV business, including the long-acting collaboration that you mentioned, Tridelvi, Magrolomab, cell therapy, and a number of other programs, essentially what ARCIS programs are expected to do. drive our long-term growth.

Speaker from Gilead: In the short run, we see a much more promising growth profile than we did historically. So we think that we've done a lot to turn the company around, and now the growth profile is improving significantly from our perspective. When you get to 24 or 25, again, we said we see an expected inflection in our growth profile as a lot of these programs that are currently in the clinic hopefully reach commercialization, including a number of Trudelevy programs.

Speaker from Gilead: On Trudevieve's Specifically, I think we continue to be very bullish on the prospects for Trudevie overall, so we're back to where we were when we did the transaction. As you recall, we highlighted there were a number of ways to win with Trudelevy when we acquired immunometics. The hormone receptor positive study was just one of those studies.

Speaker from Gilead: Obviously, we're excited about the work that we're doing in lung cancer and other areas. So there's a much broader clinical development plan for Trudelvey. Then the market probably fully appreciates today that the announcement with Merck earlier today is a good example of that, that will give you a sense of where we're going, and we expect to give you a much greater sense of that overall. So I think at a macro level, before I asked Joanna to comment, I'd say our expectations for Tridelvey have not changed. We continue to be very enthusiastic about where we are and where we're going, and there are lots of different ways for us to get there over time. Yeah, no, thanks.

Speaker from Gilead: Yeah, no, thanks, Andy. I would just add that, in the short term, I think we are pleased with where we're going with Trudelevy today. We still believe that there are a lot of growth opportunities, specifically in the earlier line setting, both across triple negative breast cancer as well as bladder cancer. And so we're seeing those opportunities play out. I think the guidelines are going to help us set up for success, let alone set up for future pipeline studies such as HR positive coming through, hopefully in a positive way, as you, as you, as you mentioned, and that should just then expand our market opportunity even more.

Speaker from Gilead: The only thing I would add to what Andy was saying is on the HIV front, so not looking just at the oncology opportunities but also from an HIV standpoint, we still believe that Carvey is foundational to our HIV opportunities in addition to, of course, Lana Capavia that Muraddad spoke to earlier. So we're excited about what we have going on there as well.

Speaker from Gilead: Good afternoon, and thank you for taking my questions.

Speaker from Gilead: Yeah, hi Ronnie, it's Andy. Thank you for the question. It's relatively straightforward. This is a straightforward, simple, clinical collaboration. Merck is providing Trudelvey. They obviously had input on the study design. Providing Ktruda, I'm sorry, Ktruda, TV study, thank you. They do not have any economic interest in Trudelvey as a result.

Speaker from Gilead: And it's part of our strategy, right, Ronnie, to scale the opportunity with Trudelby because there are many things we can do ourselves, but frankly, given the multi-tumor opportunity for Trudelby, engaging in partnerships like this allows us to do much more than we could ourselves. And I think it's the beginning of what you'll see from us as we look to really, you know, expand out the promising potential of Trudelby.

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Brian Skorney: Okay, our next one comes from Brian Scornie with Baird. Your line is open.

Speaker from Gilead: Hey, good afternoon, everyone. Thank you for taking the question. I guess we'll be seeing a bunch of potentially transformative data in large B-cells in a moment, a couple of months, I assume, at Ash. I guess, in addition to your own data, just kind thoughts on giving the Pilaric success. How do you think about the potential for Cart 19 to move upwards into the front-line setting, and does the success of Pallivi actually change the market opportunity, in your view, for second line as well?

Speaker from Gilead: Thanks. Thanks, Brian. Christy,

Speaker from Gilead: Oh, sure. So, yes, we're very excited about our submission at the end of September for second line and expect to hear back on the status from FDA in the first half of next year. But we will be presenting the data at Ash, as you said. And, you know, CarT is really the only potential cure we're seeing right now. So when you look at the out-of-class second-line agents and move to front-line, there typically has been a delay to CAR-T. And now with this new study coming out, we'll have to see what that exact duration will be for those patients. We hope it will be successful, but we don't see a huge impact on our projections in the cell therapy marketplace. The second line actually allows us to double the market.

Speaker from Gilead: Second Line actually allows us to basically double the market that we can play in, which is about 14,000 patients in the U.S. That combined with, you'll also see our frontline data, Zuma 12, which was completed. We'll be presenting that at Ash as well. So you'll see our front line, second line, and see how some of them may stack up, although they're not head-to-head trials. So we're pretty confident in where we are, and it doesn't really change our projections for the future of cell therapy or for our specific brands.

Carter Gould: Our last question comes from Carter Gould with Barclays. Your line is open. Great, good afternoon, thanks for squeezing me in. Maybe just one on the lung.

Speaker from Gilead: Great, good afternoon, thanks for squeezing me in. Maybe just one on the lung study that's going to get started later this year for Trudelvey. You've characterized starting that study as risky, but presumably you've had some insight from the basket study. Is that a fair assumption? And could we see data from that basket study maybe by the time we see Tropics II data? Thanks, great question.

Speaker from Gilead: We're looking at the totality of the data we have. It's not just the Tropics 3 data. We're looking at the totality of the data in Lung that we have, and we've accumulated, and that's really the approach we're taking. So I take your point, and, you know, it's arguably not a bigger risk, given the data we've seen. I would not expect for us to be sharing those data around the time of the tropics too, but we do, you know, we will plan on sharing those data, you know, over time. So we'll definitely share those data over time. For now, we're pretty excited by what we've seen in terms of the Trudeleville performance in non-smiles. Thanks, Connor.

Operator: That's all the time we have for her question. I'd like to turn the call back to Jackie Ross for closing remarks. Thank you, Catherine, and thank you all for joining us today. We appreciate your continued interest in Gilead and look forward to updating you on our progress. This concludes today's conference call. Thank you for participating. You may now disconnect. I'm going.

Operator: and I'm gonna' all. I'm gonna be able to be.

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Operator: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.

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