Q2 2021 Gilead Sciences Inc Earnings Call

July 29, 2021

[music].

Good day, and thank you for standing by and welcome to the Gilead.

Operator: Thank you for standing by. Welcome to the Gilead Sciences second quarter 2021 earnings conference call.

So second quarter 2021 earnings conference call at this time, all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded if.

Operator: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to our speaker today, Jacquie Ross, VP of Investor Relations. Please go ahead.

You acquire any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today, Jackie Roth VP Investor Relations. Please go ahead.

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

Thank you al and good afternoon, everyone.

Just after market close today, we issued a press release with earnings results for the second quarter 2021.

The press release slides and supplementary data are available on the investors section of our website at Gilead Dot com.

The speakers on today's call will be our chairman and Chief Executive Officer, Daniel O'day, Our Chief Commercial Officer, Joanna Murphy, our Chief Medical Officer, Murdock, Parsi and our Chief Financial Officer, Andrew Dickinson After that we'll open up.

Jacquie Ross: After that, we'll open up the call to Q&A, where the team will be joined by Christy Shaw, the Chief Executive Officer of KITE. Before we get started, let me remind you that we will be making forward-looking statements, including those related to the impact of the COVID-19 pandemic on Gilead's business, financial condition and results of operation, plans and expectations with respect to products, product candidates, corporate strategy, financial projections, and the use of capital, and 2021 financial guidance, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these.

The call to Q&A, where the team will be joined by Christi Shaw, The Chief Executive Officer of Kate.

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

Spec to products product candidates corporate strategy financial projections, and the use of capital and 2021 financial guidance all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

Jacquie Ross: A description of these risks can be found in the earnings press release and our latest SEC disclosure document. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statement. Non-GAAP financial measures will be used to help you understand the company's underlying business performance.

A description of these risks can.

In the earnings press release, and our latest SEC disclosure documents.

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

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

Can be found a GAAP to non-GAAP reconciliations are provided in the earnings press release, and our supplemental data sheet as well as on the Gilead website.

I will now turn the call over to Dan.

Thank you Jackie and good afternoon, everyone. Thanks for taking the time to join US here today. We are pleased to provide you with an update on our second quarter, where we delivered.

Daniel O'Day: Thanks for taking the time to join us here today. We're pleased to provide you with an update on our second quarter, where we delivered solid financial performance and significant progress in our increasingly diverse pipeline. 2021 is an important year for our pipeline, and we're very encouraged by the milestones we've achieved for therapies that are potentially transformative for Gilead and for patients. All of this reinforces our confidence in our strategic direction.

Solid financial performance and significant progress on our increasingly diverse pipeline.

2021 is an important year for our pipeline and we're very encouraged by the milestones we've achieved for therapies that are potentially transformative for gilead and per patient.

All of this reinforces our confidence in our strategic.

And functional.

Daniel O'Day: I want to take this opportunity to thank our global community of Gilead and Kite employees who consistently go above and beyond to drive progress with resilience and dedication. Different parts of the world are riding the ebb and flow of COVID-19 cases at various times, and while the vaccines give us hope and optimism, we are still very much living with the pandemic. Remdesivir continues to play an important role in fighting the virus and has now been used to treat an estimated 7 million hospitalized patients worldwide.

I want to take this opportunity to thank our global community of Gilead, and kite employees, who consistently go above and beyond to drive progress with resilience and dedication.

Current parts of the World are riding the ebb and flow of COVID-19 cases at various times and while the vaccines give.

US hope and optimism we are still very much living with the pandemic.

Industrial continues to play an important role in fighting the virus and has now been used to treat an estimated 7 million hospitalized patients worldwide.

Daniel O'Day: Turning to the main highlights of the quarter on slide four, the second quarter was a solid quarter overall, but glory sales of $829 million were once again higher than anticipated, offsetting the lingering impact of the pandemic, particularly on HIV treatment. In light of this pandemic impact, Biktarvi's performance is quite encouraging. Revenue for the quarter was $2 billion U.S. dollars, up 24 percent, or $390 million from the same quarter last year. This more than offset the $322 million headwind associated with the impact of the Truvada and Etripola LOEs. Much of that headwind is now, of course, behind us.

Turning to the main highlights of the quarter on slide 4 the second.

Victory was a solid quarter overall <unk> sales of $829 million were once again higher than anticipated offsetting the lingering impact of the pandemic, particularly on HIV treatment.

In light of this pandemic impact <unk> performance is quite encouraging revenue for the quarter was.

With $2 billion up 24% or $390 million from the same quarter last year.

This more than offset the $322 million headwind associated with the impact of the truvada in a triplet eloise.

Much of that headwind is now of course behind us.

Quarter overall, our share of the HIV treatment, Mark and held steady quarter over quarter and our prep share remained steady even with generic entries. These.

Daniel O'Day: Overall, our share of the HIV treatment market held steady quarter over quarter, and our PrEP share remained steady even with generic entry. These dynamics give us confidence that the underlying demand for our HIV products remains strong and positions us well for growth as the overall HIV market recovery gains momentum. Moving to our clinical pipeline, 2021 is a catalyst-heavy year for Gilead, and we've delivered all of our key first-half pipeline commitments. Among other milestones, we shared top-line data from the highly anticipated ZUMA 7 trial, where Yaskarta improved event-free survival for second-line large B-cell lymphoma, or LBCL, patients by 60% compared to the standard of care.

These dynamics give us confidence that the underlying demand for our HIV products remains strong and positions us well for growth as the overall HIV market.

Free gains momentum.

Moving to our clinical pipeline 2021, as a catalyst to every year for Gilead and we've delivered all of our key first half pipeline commitments.

On the other milestones we shared top line data from the highly anticipated Zuma 7 trial.

Recovery is skarda improved event free survival for second line large b cell lymphoma, or <unk> patients by 60% compared to the standard of care.

Daniel O'Day: This is truly a landmark trial, the first and largest reported phase 3 trial readout that demonstrates the efficacy and safety of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier life. We shared positive phase 3 data from MIR 301, which will help support our anticipated BLA filing for Habcludex for HDV in the U.S. later this year. And we submitted our NDA for use of Lenacapavir in the heavily treatment-experienced population with multi-drug resistance. This filing was based on data from the Phase 2-3 Capella study presented earlier this month.

This is truly a landmark trial, the first and largest reported phase III trial readout that demonstrates the efficacy.

Will it be of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier lines.

We shared positive phase III data from mirror, 301, which will help support our anticipated BLA filings per <unk> for H D.

PNC in the U S. Later this year and we submitted our NDA for use of <unk> in the heavily treatment experienced population with multi drug resistance.

This filing was based on data from the Phase III 3 Capella study presented earlier this month.

Daniel O'Day: We also shared strong lenacapavir data from the Phase 2 Calibrate study in HIV treatment, which will be used to inform our broader lenacapavir effort. Our partner AHRQ has provided an interim update from AHRQ 7 that supports the continuation of both AHRQ 7 and AHRQ 10 trials for their anti-TTIC candidate, Dunvanellumab. Lastly, on slide four, we're beginning to see the positive impact of our strategy, which we introduced early last year.

We also shared strong learner cap of your data from the.

<unk> calibrate study in HIV treatment, which will be used to inform our broader Atlantic half of your efforts.

Our partner ARCUS provided an interim update from <unk> 7 that supports the continuation of both <unk> and <unk> trials for their anti <unk> candidate John Vanilla Mab.

Lastly on slide 4 we are beginning to see the positive impact of our strategy, which we introduced early last year.

Daniel O'Day: The business is diversifying across indications and therapies. In particular, we are seeing cell therapy and TRODELV contribute to growth, and we expect they will be key growth drivers for Gilead. While we build out the oncology business, we remain focused and committed to ensuring the long-term competitive positioning of our virology portfolio. Next, on slide five, we highlighted our pipeline execution so far this year, and I'd like to thank all those who helped us to deliver on this ambitious agenda, including our employees, the people who participated in the studies, our partners, and the study investigators.

The business is diversifying across indications and therapies in particular, we are seeing cell therapy, and <unk> contribute to growth and expect they will be key growth drivers for gilead, while we build.

Phase ecology business, we remained focused and committed uninsured in the long term competitive positioning of our virology portfolio.

Next on slide 5 we highlighted our pipeline execution. So far this year and I'd like to thank all those who helped us to deliver on this ambitious agenda, including our employees.

The people who participated in our studies our partners and our study investigators.

Daniel O'Day: As we look ahead to the rest of the year, our target milestones include a progression-free survival or PFS readout in our event-driven Phase III Tropics II study evaluating TRODELV in hormone receptor HER2-positive negative metastatic breast cancer, a Phase 1b readout from Agrolimab and Myelodysplastic Syndrome or MDS. Depending on the data, timing, and results, this could result in a BLA submission for accelerated approval and the initiation of the potential phase 3 Lenacapivir and Aslapsivir long-acting oral combination. As you know, this is in collaboration with Merck, and the development and formulation work remain on track. We look forward to updating you next quarter about the additional milestone progress.

As we look ahead to the rest of the year. Our target milestones include a progression free survival or PFS readout in our event driven phase III tropics, <unk> study evaluating <unk> in hormone receptor.

Out the her 2 positive net negative metastatic breast cancer.

Our phase <unk> readout from our goal amount in myeloma dysplastic syndrome, or Mds, depending on the data timing and results. This could result in a BLA submission for accelerated approval.

And initiation of the potential phase III <unk>.

<unk> long acting oral combination as.

As you know this is in collaboration with Merck and the development and formulation work remains on track.

We look forward to updating you next quarter about the additional milestone progress.

Johanna Mercier: We understand the continued strong and consistent pipeline execution is critical to extending the virology business and expanding further into oncology. We believe our current and pipeline therapies can address significant unmet medical needs. We are very encouraged by the progress Gilead and Kite are making. We are well on our way in our journey to expand and diversify in new therapeutic areas, and we are already seeing the evolution of both our pipeline and commercial portfolio. With that, I'll hand over to Johanna, who will share an update on our commercial performance for the second quarter. Thanks, Dan, and good afternoon, everyone.

We understand that continued strong and consistent pipeline execution is.

These are critical to the extending the virology business and expanding further into oncology, we believe our current and pipeline therapies can address significant unmet medical needs.

We are very encouraged by the progress Gilead and kite are making we are well on our way in our journey to expand and diversify into.

New therapeutic areas and we are already seeing the evolution of both our pipeline and commercial portfolio.

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

Thanks, Dan and good afternoon, everyone.

Johanna Mercier: Starting on slide 7, total product sales of $6.2 billion were up 21% year-over-year, primarily reflecting Vicklery, which was not a contributor to revenue in the second quarter of 2020. On slide 8, Glory's second-quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection and hospitalization in many regions. While hospitalizations trended lower in the second quarter, the question remained the therapy of choice in three out of five patients hospitalized with COVID-19.

Starting on slide 7 total product sales of $6.2 billion.

21% year over year, primarily reflecting the clarity, which was not a contributor to revenue in the second quarter of 2020.

On slide 8 declared a second quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection hospitalization in many regions.

<unk> brother Hospitalizations trended lower in the second quarter that Gary remained debt. There is the therapy of choice in 3 out of 5 patients hospitalized with COVID-19.

Johanna Mercier: We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with remdesivir. It's truly remarkable and encouraging to see how remdesivir continues to play such a key role in fighting this global pandemic. Excluding that, total product sales of $5.3 billion were up 5% year-over-year.

We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with <unk>, it's truly remarkable and encouraging to see how <unk> continues.

To play such a key role in fighting this global pandemic.

Excluding debt clearly total product sales at $5.3 billion were up 5% year over year.

Johanna Mercier: We saw growth in cell therapy and HCV, in addition to new revenue contributions from Tredelvi and, more modestly, Hep Cludex for HDV. Additionally, other product revenues of $291 million grew 20% year-over-year, driven by increased demand for ambazone outside of the U.S. to treat mucormycosis, which has seen a rise in incidence in patients hospitalized with COVID-19. sequentially, we saw 9% growth in total product sales, excluding Veclari, primarily driven by growth in BigTarBit.

We saw growth in cell therapy, and HCV. In addition to new revenue contributions from <unk> and more modestly have crude ex for HDD.

Additionally.

Got it revenues of $291 million grew 20% year over year, driven by increased demand for Amazon outside of the U S to treat nuclear mycosis, which has seen it rising incidents in patients hospitalized with COVID-19.

Sequentially, we saw 9% growth per total product sales excluding.

<unk>, primarily driven by growth in Victorville.

Johanna Mercier: Moving to slide 9, HIV product sales were $3.9 billion, up 8% sequentially, and down 2% year-over-year. Compared to the second quarter of 2020, total HIV revenue reflected strong big target growth that more than offset the $322 million lower revenue from Truvada and Atripla following their loss of exclusivity. Compared to last quarter, HIV grew by 288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment. Victory revenue of $2 billion was up 24% year-over-year and 9% sequentially, with quarter-over-quarter growth primarily driven by increased demand.

Moving to slide 9 HIV product sales were $3.9 billion up 8% sequentially and down 2% year over year.

Compared to the second quarter of 2020 total HIV revenue reflected strong day cabbie growth debt more than offset the 320.

Other $1 billion lower revenue from Nevada, and a trip last following the loss of exclusivity.

Compared to last quarter, HIV grew $288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment.

<unk> revenue of $2 billion was up 24% year.

Over year, and 9% sequentially with quarter over quarter growth, primarily driven by increased demand.

Johanna Mercier: Vicarvi remains the number one prescribed therapy in the U.S. across nave, switch, and continuing patients, and remains number one in nave across all EU5 countries. Additionally, approximately 70% of switches from both Gilead and non-Gilead regimens result in incremental revenue. Overall, and despite the ongoing impact of the pandemic, BigTurvy continues to gain market share with 1% share growth versus last quarter in both the U.S. as well as the EU5. Discovey revenues of $435 million grew 21% sequentially due to modest improvement in the demand for PrEP and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first.

The current <unk> remains the number 1 prescribed therapy in the U S across naive switch and continuing patients and remains number 1 in naive across all EU countries.

Approximately 70%.

<unk> thousand 2 midstream does gilead and non Gilead regimen result in incremental revenue.

Overall and despite the ongoing impact of the pandemic victory continues to gain market share with 1% share growth versus last quarter in both the U S as well as the EU 5.

<unk> revenues of 430.

$5 million grew 21% sequentially due to a modest improvement in the demand for prep and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first.

Johanna Mercier: As we highlighted in prior quarters, we've been working with payers to ensure patients continue to have access to SCOBY in light of the entry of generic alternatives for Travada. We're really pleased to see the strong sequential growth in DyscoVie, and we continue to maintain mid-40% share despite generic imps. Year over year, Dyscove grew 4%, largely due to higher demand for PrEP. Overall, PrEP demand is showing signs of recovery and is expected to continue to improve as the effects of the pandemic fade. Earlier this month, federal FAQs for the U.S. Preventative Services Task Force were released.

As we highlighted in prior quarters, we have been working with payers to ensure patients continue to have access to the scobey in light of entry of generic alternatives for Truvada.

We're really pleased to see the strong sequential growth in discovery and we continue to maintain mid 40% share despite generic impacts.

Year over year day, Scobey grew 4% largely due to higher demand for prep and overall prep demand is showing signs of recovery and is expected to continue to improve as pandemic restrictions.

Stays out.

Earlier this month federal ethic used for the U S. Preventative services Task Force were released.

It provided greater clarity as to the importance of prep in ending the epidemic and we're really encouraged by this recent development. We hope it will help to minimize the barriers of profit use going forward.

Before I transition to other products I just wanted to take a moment to share some perspective on the HIV treatment market given the longer than expected pandemic impact.

Johanna Mercier: It provides greater clarity as to the importance of PrEP in ending the epidemic, and we're really encouraged by this recent development. We hope it will help to minimize the barriers to PrEP use going forward. Before I transition to other products, I just wanted to take a moment to share some perspective on the HIV treatment market given the longer-than-expected pandemic impact. In regions outside of the U.S., such as Europe, we're beginning to see signs of recovery in the dynamic market, with second quarter trends generally in line with our expectations.

In regions outside of the U S such as Europe, we're beginning to see signs of recovery in the dynamic market with second quarter trends generally in line with our expectations.

In the U S. However.

And due to the pandemic recover with slower than we expected in this last quarter and while we see signs of recovery in prep and some sequential growth in the treatment market. It's clear that it will take several quarters per treatment to return to pre pandemic levels.

In treatment, there really to pandemic related headwinds that we observed first.

Johanna Mercier: In the U.S., however, the pace of the pandemic recovery was slower than we expected in this last quarter. And while we're seeing signs of recovery in PrEP and some sequential growth in the treatment market, it's clear that it will take several quarters for treatment to return to pre-pandemic levels. In treatment, there are really two pandemic-related headwinds that we observed. Lower HIV screening and diagnosis result in lower treatment initiation. And second, due to the limited support services available during the pandemic, we've seen a higher number of patients discontinue their HIV treatment.

Lower HIV screening and diagnosis, resulting in lower treatment initiation and second due to the limited support services available during the pandemic, we have seen a higher number of patients discontinue their HIV treatments.

Taken together these 2 factors have reduced the number of active patients on HIV therapy entering.

The <unk>, 1, thereby reducing the overall volume of new and refill prescriptions, we would expect to see in 2021, we.

We did however, see growth resumed from this lower base in the second quarter.

After prior quarter quarter over quarter declines second quarter U S. HIV treatment prescriptions grew 2% and we expect the market to.

<unk> historical rates, 1 screening and diagnosis rates return to pre pandemic levels.

To continue our efforts to advance progress against the HIV epidemic, we're partnering with health care professionals advocacy groups and policymakers to raise awareness of the unique challenges of COVID-19 poses to HIV screening diagnosis and adherence.

Johanna Mercier: Taken together, these two factors have reduced the number of active patients on HIV therapy entering 2021, thereby reducing the overall volume of new and refilled prescriptions we would expect to see in 2021. We did, however, see growth resume from this lower base in the second quarter.

Our goal is to help health care providers ensure that patients continue to be diagnosed and treated.

Given the strength of the demand fundamentals for victory discovery for prep and other Gilead HIV products, we remain confident in our competitive positioning now that many communities are easing social distancing requirements.

Johanna Mercier: After prior quarter over quarter declines, second quarter US HIV treatment prescriptions grew 2%, and we expect the market to grow at historical rates once screening and diagnosis rates return to pre-pandemic levels. To continue our efforts to advance progress against the HIV epidemic, we're partnering with health care professionals, advocacy groups, and policymakers to raise awareness of the unique challenges COVID-19 poses to HIV screening, diagnosis, and adherence. Our goal is to help health care providers ensure that patients continue to be diagnosed and treated.

In the meantime.

We continue to see strength in underlying treatment demand with no material changes in the competitive landscape with our total gilead treatment market share holding steady at 75% in the U S and just under 50% in Europe, Despite competition and the entry of new generics.

Okay.

Next on slide 10.

<unk> HCV product sales in the second quarter were $549 million up 23% compared to last year. The patient starts remained well below pre pandemic levels.

The growth reflects a modest sequential recovery in HCV patient starts in the U S.

In Q2 dollars 21. In addition to an artificially low Q2 of 'twenty that was impacted.

Johanna Mercier: Given the strength of the demand fundamentals for Victarvi, Dyscovi for PrEP, and other Gilead HIV products, we remain confident in our competitive positioning now that many communities are easing social distancing requirements. In the meantime, we continue to see strength in underlying treatment demand with no material changes in the competitive landscape, with our total Gilead treatment market share holding steady at 75% in the U.S. and just under 50% in Europe, despite competition and the entry of new genera.

Meantime, favorable government rebate adjustments.

We will be watching for further signs of recovery in the third quarter, both U S and EU Gilead market share has remained steady at around 60% and 50% respectively.

Moving to slide 11.

<unk> HBV in HDD product sales were $237 million up 8% year on.

Per year with improving patient starts on <unk>, particularly in ex U S market.

In its first full quarter as part of Gilead have crude ex contributed $7 million and is currently available in France, Germany, and Austria, we're excited to be working with the various reimbursement authorities.

Johanna Mercier: Next on slide 10, HCV product sales in the second quarter were $549 million, up 23% compared to last year, but patient starts remain well below pre-pandemic levels. The growth reflects a modest sequential recovery in HCV patient starts in the U.S. in Q2-21 in addition to an artificially low Q2-20 that was impacted by unfavorable government rebate disasters. We'll be watching for further signs of recovery in the third quarter. Both the U.S. and E.U.

To increase patient access and expect to secure full reimbursement.

And the major European markets in 2022.

Moving to <unk> on slide 12 product sales in the second quarter were $89 million up 24% quarter over quarter driven by demand for the 2 new indications approved in April, namely second line, plus metastatic triple negative breast cancer and <unk> cancer.

We continue.

You need to be encouraged by the positive feedback from physicians on the phase III ascent data, which demonstrated 1 year medium overall survival benefit for second line metastatic <unk> patients treated with <unk>.

Johanna Mercier: Gilead market shares remain steady at around 60% and 50% returns. Moving to slide 11, HPV and HDV product sales were $237 million, up 8% year-over-year, with improving patient starts on darmaity, particularly in ex-U.S. markets. In its first full quarter as part of Gilead, HEP CLUDEX contributed $7 million and is currently available in France, Germany, and Ireland. We're excited to be working with the various reimbursement authorities to increase patient access and expect to secure full reimbursement in the major European markets in 2022.

To build on this growing interest, we're increasing community awareness, especially of the expanded indication to second line in <unk>.

We expect to see growing demand as breast cancer screening ramps back up to pre pandemic levels.

<unk> data suggests that breast cancer screening volumes were about 20% lower in the U S in 2020 compared to 2019.

This suggest as many as 41500 breast cancer patients have not been diagnosed.

And the pandemic.

On behalf of Christie and the kite team I'm pleased to share our cell therapy commercial update on slide 13.

Total cell therapy product sales totaled $219 million in the second quarter, representing 39% growth year over year, driven by both your startup and to Curtis.

Johanna Mercier: Moving to Jidovi on slide 12, product sales in the second quarter were $89 million, up 24% quarter-over-quarter, driven by demand for the two new indications approved in April, namely second-line plus metastatic triple-negative breast cancer and urothelial cancer. We continue to be encouraged by the positive feedback from physicians on the phase three ascent data, which demonstrated a one-year medium overall survival benefit for second-line metastatic TN To build on this growing interest, we're increasing community awareness, especially of the expanded indication for Second Line in TNBC. And we expect to see growing demand as breast cancer screening ramps back up to pre-pandemic levels. IQVIA data suggests that breast cancer screening volumes were about 20% lower in the U.S. in 2020 compared to 2019.

You start growth was driven by strong demand in Europe as well as successful Follicular lymphoma launch in the U S.

Increased competition, particularly in third line <unk> Bcl continues to raise the profile of cell therapy and is positive to create overall.

We remain confident in <unk> competitive profile and positioning and are particularly.

Shareholders of <unk> industry, leading manufacturing turnaround time and reliability.

Our results also reflected strong momentum from the <unk> mantle cell lymphoma launch highlighting the unmet medical need for mcl patients.

We continue to add new indications and geographies for our cell therapy products for example, the postponed.

Lee pronged venture recently received approval in China for you started out the first cell therapy to treat third line <unk> and.

And we're excited to see the topline data for Zuma, Kevin getting us a step closer to second line <unk> cell therapy.

Even as we prepare for discussions with regulatory agencies later this year commercial and manufacturing preparations are ramping.

Johanna Mercier: This suggests as many as 41,500 breast cancer patients have not been diagnosed during the pandemic. On behalf of Christy and the KITE team, I'm pleased to share a cell therapy commercial update on slide 13. Total self-therapy product sales totaled $219 million in the second quarter, representing 39% growth year-over-year driven by both Yesarta and Takarta.

John to ensure sufficient capacity and support for second line <unk> Bcl demand in both the U S and in Europe, Chris.

Christie's here with the team to take your questions on cell therapy later in the call, but for now I'll hand, it over to Mehrdad to walk us through the pipeline updates.

Thank you Johanna.

Dan mentioned, it's been a gratifying year, so far delivered.

<unk> up on all of our key pipeline commitments supporting goods ambitions to extend our leadership in HIV and creating a broader portfolio spanning neurology and oncology building our portfolio in inflammation.

Johanna Mercier: The start of growth was driven by strong demand in Europe, as well as a successful follicular lymphoma launch in the U.S. Increased competition, particularly in third-line LBCL, continues to raise the profile of cell therapy and is positive to CHITE overall. We remain confident in Yaskarta's competitive profile and positioning and are particularly proud of Kite's industry-leading manufacturing turnaround time and reliability.

I'll spend our time today on the highlights of the quarter and pointed to the appendix of the earnings presentation for a more complete view of our pipeline activities.

Activities.

First in HIV as you can see on slide 15 programs for our investigational lytic catheters.

<unk> continued to progress.

At the recent International AIDS Society meeting, we shared data from the phase II III Capella study that evaluated heavily treatment experienced individuals who've already developed positions to multiple anti.

Johanna Mercier: Our results also reflected strong momentum from the Ticardus Mantle Cell Lymphoma launch, highlighting the unmet medical need for MCLT. We continue to add new indications and geographies for our cell therapy. For example, the Fosun Kite Joint Venture recently received approval in China for Yaskarta as the first cell therapy to treat third-line LBCL, and we're excited to see the top-line data for ZUMA 7, getting us a step closer to second-line LBCL cell therapy.

Anti retroviral viral drugs.

Capello demonstrated <unk> potency in this difficult to treat population.

Despite significant prior resistance antiviral activity was observed starting at day 15.

By week 26, 81% of individuals' high viral suppression with <unk> combined with an optimized background regimen.

Johanna Mercier: Even as we prepare for discussions with regulatory agencies later this year, commercial and manufacturing preparations are ramping up to ensure sufficient capacity and support for second-line LBCL demand in both the U.S. and in Europe. Christy is here with the team to take your questions on cell therapy later in the call. But for now, I'll hand it over to Merdad to walk us through the pipeline. Thank you, Johanna.

Based on these data we filed a new drug application.

If approved this would become the first 6 month long acting subcutaneous injection regiment available and deliver a welcome new option for people living with HIV, who have developed multi drug resistance to other antiretrovirals.

Also with Ias represented strong interim.

Interim results from the Phase III calibrate study evaluating <unk> in the treatment naive population.

Merdad V. Parsey: As Dan mentioned, it's been a gratifying year so far, delivering on all our key pipelines, supporting Gilead's ambitions to extend our leadership in HIV, and creating a broader portfolio spanning virology and oncology. Building our portfolio. I'll spend our time today on the highlights of the quarter and point you to the appendix of the earnings presentation for a more complete view of our pipeline. First in HIV, as you can see on slide 15, programs for investigational linocapivir agents continue to progress. At the recent International AIDS Society meeting, we shared data from the Phase II-III Capella Study that evaluated heavily treatment-experienced individuals who've already developed resistance to multiple antiretroviral drugs. Capella demonstrated linocapivir's potency in this difficult-to-treat population.

And calibrate.

<unk> received <unk> of your either as a subcutaneous injection or a daily oral pill and combination with discovery.

At week 28, 94% of subjects achieved.

<unk>.

1 RNA loads of less than 50 copies per Mil. These.

These findings will be used to help inform our broader efforts, establishing <unk> as a foundational agent for a long acting franchise.

Late last month, we screened our first patient for the phase III purpose, 2 trials studying lending caps of year for HIV prevention and cisgender men.

Men transgender women transgender men and gender nonbinary people, who have sex with men and our risk of HIV infection.

We expect to initiate the phase III purpose, 1 study of lending half of year for HIV prevention, and adolescent girls and young women later this year.

Merdad V. Parsey: Despite significant prior, antiviral activity was observed starting at day By week 26, 81% of individuals had viral suppression when Lenacapivir was combined with an optimized background. Based on these data, we filed a new drug application. If approved, this would become the first six-month-long acting subcutaneous injection regimen available and deliver a welcome new option for people living with HIV who have developed multidrug resistance to other antiretroviral drugs. Also at IAS, we presented strong interim results from the Phase II Calibrate Study, evaluating Lenacapavir in treatment-naive patients.

Finally, we are actively working on a co formulation.

<unk>.

The long acting investigational oral and injectable combination of blended cap of hearing this latter of the year and expect to initiate the oral phase II trial by the end of the year.

Moving onto HBV on slide 16 last month at the International liver Congress, we presented data from the mere 301 and near 204 program.

301 is a phase III Registrational study evaluating <unk>.

We leveraged high as monotherapy for the treatment of HBV.

Interim results demonstrated that <unk> was well tolerated, both cirrhotic and non cirrhotic patients with compensated chronic HBV infection.

And we 24 deleveraging.

<unk> treatment was associated with significantly greater HBV, RNA declines and improvements in biochemical measures of disease activity compared to no treatment.

Merdad V. Parsey: In Calibrate, participants received Lenacavivir either as a subcutaneous injection or as a daily oral pill in combination with the scope. At week 28, 94% of subjects achieved HIV-1 RNA loads of less than 50 copies per minute. These findings will be used to help inform our broader efforts establishing Lena Capovir as a foundational agent for our long activity.

Moreover, there were no treatment related serious adverse events leading to discontinuation.

These results continues to support the effectiveness of the 2 milligram dose which has received conditional.

Program approval from the EMA and will form the basis of the BLA filing claim planned for later this year in the U S.

As part of our HDD cure efforts. We also presented interim data from the mirror to have 4 phase II <unk> study investigating finite regimens of Delever types, both as monotherapy and in combination with.

Merdad V. Parsey: Late last month, we screened the first patient for the Phase 3 Purpose 2 trial, studying Lenacapivir for HIV prevention in cisgender men, transgender women, transgender men, and gender non-binary people who have sex with men and are at risk of HIV. We expect to initiate the Phase 3, Purpose 1 study of Lenacavivir for HIV prevention in adolescent girls and young women later this Finally, we're actively working on a co-formulation for the long-acting investigational oral and injectable combination of lenacapavir and islatravir and expect to initiate the oral phase two trial by the end of the year.

Peg interferon alpha.

Both monotherapy and combination treatments of <unk> were found to be generally well tolerated and more effective and peg interferon alone through 24 weeks of therapy.

The primary endpoint analysis occurs at 24 weeks after completion of therapy and includes biologic and biochemical response data.

We look forward.

And to sharing those data when available.

Moving to slide 17.

And on behalf of Christina the kite team as you know we shared earlier the strong positive topline data from Zuma 7.

The landmark 359 patient phase III study evaluating <unk> in second line <unk>.

Merdad V. Parsey: Moving on to HDV on slide 16, last month at the International Liver Congress, we presented data from the MIR 301 and MIR 204 programs. MIR 301 is a Phase III Registrational Study evaluating Gilebertide as monotherapy for the treatment of HDV. Interim results demonstrated that Levertide was well-tolerated in both cirrhotic and non-cirrhotic patients with compensated chronic HDV infection. At week 24, Levertide treatment was associated with significantly greater HDV RNA declines and improvements in biochemical measures of disease activity compared to no treatment. Moreover, there were no treatment-related serious adverse events leading to discontinuation.

Study met the primary endpoint for event free survival with a hazard ratio of <unk> 398, representing a 60% improvement and event free survival compared to standard of care stem cell transplant.

<unk> had a safety profile comparable to or better than what we've seen in the third line setting. This is a clinically and statistically meaningful improve.

Improvement in outcomes that if approved in the U S could extend <unk> reach to a total unique population of 14000 patients annually in the second and third line LDC.

<unk>.

Zuma 7 also met the key secondary endpoint of objective response rate as expected data for overall survival is immature.

At this time, but the interim analysis suggests a favorable trend in this critical milestone.

In summary, we're very excited about the potential benefit to patients demonstrated in June 7 and look forward to beginning discussions with regulatory agencies. Later this year as we work towards potential BLA and MAA filings for <unk> in second line <unk> and.

Merdad V. Parsey: These results continue to support the effectiveness of the 2 mg dose, which has received conditional approval from the EMA and will form the basis of the BLA filing plan for later this year in the U.S. As part of our HPV cure efforts, we also presented interim data from the MIR-204 Phase 2b study investigating finite regimens of bilabatide both as monotherapy and in combination with PEG interferon. Both monotherapy and combination treatments of The primary endpoint analysis will occur at 24 weeks after completion of therapy and will include virologic and biochemical response data.

And separately, we are on track for the phase III readout for our first line <unk> study before the end of the year.

Beyond <unk>, we have completed filing yes, Carter with the EMA for patients with Follicular lymphoma, after 3 or more lines of systemic therapy.

We also have a <unk> date of October 1 under accelerated review with the.

The FDA for <unk> <unk> and.

And of course, while our internal focus remains on autologous cell therapies, we continue our engagement and alternative approaches most recently partnering with shoreline <unk> biosciences to develop novel off the shelf allogeneic cell therapies based on natural killer targets for hematologic cancers.

Merdad V. Parsey: We look forward to sharing those data when available. Moving to slide 17, and on behalf of Christy and the KITE, As you know, we shared earlier the strong positive top-line data from Zuma 7. The Landmark 359 Patient Phase 3 Study Evaluating Yaskarta and Second Line LBCL. The study met the primary endpoint for event-free survival, with a hazard ratio of 0.398, representing a 60% improvement in event-free survival compared to standard-of-care stem cell transmission. Yaskarta had a safety profile comparable to or better than what we have seen in the third line setting.

Slide 18 is a recap of our pipeline execution. So far this year. In addition to the items. We've discussed already our partner ARCUS provided an early interim update of their phase III <unk> trial in late June demonstrating clinical activity in the anti <unk> dominant allomap based doublet and triplet combinations.

<unk> our anti.

1 antibody saw similar levels of activity in the monotherapy arm compared to marketed anti PD ones.

Based on the interim analysis, we are pleased that arch, Kevin and the confirmatory phase III <unk> trial will continue to enroll as planned we look forward to seeing how the data mature with additional patients and duration of follow up to inform our opt.

Opt in decision.

Separately, our partner Galapagos will also share data readouts from our Toledo sic, 2.3 programs across psoriasis, and ulcerative colitis, and rheumatoid arthritis, and the plaque psoriasis data from their TIK 2 program.

Merdad V. Parsey: This is a clinically and statistically meaningful improvement in outcomes that, if approved in the U.S., could extend YesCard's reach to a total unique population of 14,000 patients annually in a second- and third-line setting. Zuma 7 also met the key secondary endpoint of objective response rate. As expected, data for overall survival are immature at this time, but the interim analysis suggests a favorable trend in this critical model. In summary, we're very excited about the potential benefit to patients demonstrated in Zuma 7 and look forward to beginning discussions with regulatory agencies later this year as we work towards potential SBLA and MAA filings for Yaskarta and second-line LBCL.

Both studies were early and had small samples and we look forward to additional data.

<unk> May also remained focus on the following upcoming milestones for <unk>, we continue to target a <unk> to PFS readout. This year. This study is an event driven phase III trial in patients with hormone receptor positive <unk> negative metastatic breast cancer.

Pending data, we will evaluate an intermittent the appropriate regulatory next steps.

We estimate there are roughly 17000 patients in the U S who could benefit from <unk> in this setting.

We continue to expect the phase III non small cell lung cancer.

Petrodelta to initiate in the second half of this year, we plan to share an update from the tropics III basket study on lung cancer later, this year and will.

We provide updates on head and neck squamous cell carcinoma, and endometrial cancer as those data mature.

We anticipate a phase <unk> readout from mangrove map and Mds later, this year and pending data will engage with regulators as we explore potential BLA filing for accelerated approval.

Merdad V. Parsey: And separately, we're on track for the Phase II readouts for our first-line LVCL study before the end of the year. Additionally, beyond LBCL, we've completed filing ESCARTA with the EMA for patients with follicular lymphoma after three or more lines of systemic therapy.

If approved <unk> will be the first in class.

Separately.

Checkpoint inhibitor targeting CD 47, and Gilead first frontline oncology indications.

There's a significant unmet need for Mds with no new treatments approved in 14 years, Despite 15000, new patients being diagnosed each year in the U S alone.

Merdad V. Parsey: We also have a PDUFA date of October 1st under accelerated review with the FDA for Ticardis and ALL. And, of course, while our internal focus remains on autologous cell therapies, we continue our engagement in alternative approaches, most recently partnering with Shoreline Biosciences to develop novel off-the-shelf allogeneic cell therapies based on natural killer targets for hematologic. Slide 18 is a recap of our pipeline In addition to the items we've discussed already, our partner AHRQ provided an early interim update of their Phase 2 AHRQ 7 trial in late June, demonstrating clinical activity in the anti-tigid, domlanilumab-based doublet and triplet combination. Zimbarellamab, our anti-PD-1 antibody, saw similar levels of activity in the monotherapy arm compared to marketed anti-PD.

We continue our development efforts in AML and have enrolled are.

Macro patient in the phase III frontline AML the <unk> study.

Before I wrap up the pipeline discussion I wanted to share an update on the index severe we've decided not to move forward with an inhaled formulation of <unk> based on the results of our initial proof of concept study, suggesting suboptimal lung deposition.

First pet patient needs and the evolving pandemic, we are continuing our efforts on advancing multiple novel anti Antivirals we.

We expect to submit IND filings later this year or early next year for these agents remain committed to supporting patients through this pandemic and continuing our legacy of developing antiviral therapeutics for the treatment of emerging diseases.

Finally on slide 19, I want to recognize the teams at Gilead and kite compared to just 2 years ago. Our pipeline has grown from 30 clinical stage programs to over 50 today and resulted in a considerably more diverse set of assets that can be transformative not only for patients but for gilead.

Merdad V. Parsey: Based on the interim analysis, we're pleased that Arc 7 and the confirmatory Phase 3 Arc 10 trial will continue to enroll as planned. We look forward to seeing how the data mature with additional patience and duration of follow-up to inform our opt-in decision. Separately, our partner, Galapagos, also shared data readouts from their Toledo SICK-2-3 programs across psoriasis, ulcerative colitis, and rheumatoid arthritis and the Plex psoriasis data from their TIC-2 program. Both studies were early and had small samples, and we look forward to additional data.

The Gilead and kite teams have worked tirelessly to deliver on our pipeline.

Your line programs during this time of dramatic growth despite the pandemic.

It's a thrilling time to be part of the team with tireless dedication and commitment to helping patients.

Forward to updating you on our progress in the quarters ahead.

With that I'll hand, the call over to Andy to walk us through the financial results of the quarter.

Thank you Mehrdad.

And good afternoon, everyone move.

Moving to slide 21, our financial results in the second quarter were solid overall with total product sales up 21% year over year, given the important role debt Glory continues to play in this pandemic excluding.

Excluding back Laurie total product sales grew 5% year over year with strong.

RV growth more than offsetting lower truvada in a triplet revenues. In addition to impressive growth in cell therapy and of course, the new revenue contribution associated with <unk>, which was not part of our portfolio in the second quarter of last year.

Merdad V. Parsey: Pending data, we will evaluate and determine the appropriate regulatory next steps. We estimate there are roughly 17,000 patients in the U.S. who could benefit from Tridelby in this setting. We continue to expect a phase 3 non-small cell lung cancer trial for Tredelby to initiate in the second half of this year. We plan to share an update from the Tropics III basket study on lung cancer later this year, and we'll separately provide updates on head and neck squamous cell carcinoma and endometrial cancer as those data mature.

Moving down the P&L non-GAAP product gross margin was 86.4.

<unk> in the second quarter 210 basis points higher year over year, and primarily associated with a lower royalty expense.

Non-GAAP R&D was $1.1 billion down 9% year over year with lower Rem density related investments as compared to the same period last year partly.

Offset by higher investments across our pipeline, notably <unk> and Motorola map.

Merdad V. Parsey: We anticipate a Phase 1b readout from Angrolimab and MDS later this year, and pending data will engage with regulators as we explore potential BLA filing for accelerated approval. If approved, Megrolimab will be the first in-class macrophage checkpoint inhibitor targeting CD47 and Gilead's first front-line oncology indicator.

Non-GAAP SG&A expense was $1.1 billion down 4% year over year, primarily due to lower legal expenses offset in part by continued commercial investment in <unk> outside the United States.

Merdad V. Parsey: There is a significant unmet need for MDS, with no new treatments approved in 14 years despite 15,000 new patients being diagnosed each year in the U.S. We continue our development efforts in AML and have enrolled our first patient in the Phase III frontline AML macromab study. Before I wrap up the pipeline discussion, I wanted to share an update on Remdesivir. We've decided not to move forward with an inhaled formulation of remdesivir based on the results of our initial proof-of-concept study suggesting suboptimal lung deposition.

Moving to tax we realized a lower effective tax rate of 19, 6% for the quarter were down 320 basis points year over year due to a shift in geographic earnings mix.

Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021.

1 compared to $1.11 for the same period last year the.

The year over year improvement, primarily reflects higher product sales due to back Larry prior gross margin as well as lower operating expenses and a lower effective tax rate offset by lower interest income.

Overall, we are encouraged by our first half results shown on.

Merdad V. Parsey: To address patient needs in the evolving pandemic, we are continuing our efforts to advance multiple novel antivirals. We expect to submit IND filings later this year or early next year for these agents, remain committed to supporting patients through this pandemic, and continuing our legacy of developing antiviral therapeutics for the treatment of emerging. Finally, on slide 19, I want to recognize the teams at Gilead.

Slide 22.

Moving to slide 23, you can see that we are updating our guidance for 2021 as always the duration and magnitude of the COVID-19 pandemic continue to be uncertain and the rate and degree of these pandemic impacts as well as the corresponding recovery from the pandemic may vary across our business.

With that said, we now expect full year total product sales in the range of $24.4 billion to $25 billion compared to our previous range of 23, 7% to $25.1 billion.

Merdad V. Parsey: Compared to just two years ago, our pipeline has grown from 30 clinical stage programs to over 50 today and resulted in a considerably more diverse set of assets that can be transformative not only for patients but for Gilead. The Gilead and Kite teams have worked tirelessly to deliver on our pipeline programs during this time of dramatic growth, despite the pandemic. It's a thrilling time to be part of the team with tireless dedication and commitment to helping.

The new range increases the mid point from $24.4 billion to $24.7 billion and reflects our.

Our solid results year to date as well as our updated expectations for the second half of the year.

With first half back Larry revenue of $2.3 billion. We now expect full year <unk> revenue in the range of $2.7 million to $3.1 billion compared to our previous $2 billion to $3 billion range.

Our updated range reflects the ongoing.

Inquiry in this pandemic and assumes we'll continue to see regional outbreaks.

The situation continues to be dynamic and we'll likely update our thinking again, when we report our earnings after the third quarter.

Andrew D. Dickinson: I look forward to updating you on our progress in the quarters. With that, I'll hand the call over to Andy to walk us through the financial results of the quarter. Thank you, Merdad, and good afternoon, everyone.

Back to our guidance, we now expect total product sales excluding back Larry for the year to be in the range of $21.7 billion.

Enrollment dollars to $21.9 billion.

Compared to our previous range of 21, 7% to $22.1 billion.

Andrew D. Dickinson: Moving to slide 21, our financial results in the second quarter were solid overall, with total product sales up 21% year over year, given the important role that Glory continues to play in this pandemic. Excluding Vecluri, total product sales grew 5% year-over-year, with strong Victarvi growth more than offsetting lower Truvada and Atripla revenues, in addition to impressive growth in cell therapy and, of course, the new revenue contribution associated with Tridelvi, which was not part of our portfolio in the second quarter of last year.

This tightening of the range reflects the longer than expected pandemic impact on our business, including our latest increase in COVID-19 cases.

As John has discussed the pandemic has most notably impacted our HIV.

Treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuation spend expected in 2020.

It's taking longer than we expected for treated patient volume to ramp back up to more normal levels, particularly in the United States.

That said, we saw encouraging signs of recovery in the HIV market in the second quarter and.

Our guidance assumes recovery will continue through the remainder of the year.

Based on market share dynamics, we remain very confident in our competitive positioning and we believe we are well positioned as the recovery continues.

Andrew D. Dickinson: Moving down the P&L, non-GAAP product gross margin was 86.4% in the second quarter, 210 basis points higher year over year, and primarily associated with a lower royalty expense. Non-GAAP R&D was $1.1 billion, down 9% year over year, with lower remdesivir-related investments as compared to the same period last year, partly offset by higher investments across our pipeline, notably Tredelby and Me Non-GAAP SG&A expense was $1.1 billion, down 4% year-over-year, primarily due to lower legal expenses, offset in part by continued commercial investment in Tredelvia Becklery outside the United States.

Looking at the rest of our P&L, we now expect non-GAAP product gross margin in the range of 86% to 87% reflecting.

Our mix of HIV revenue.

We now expect non-GAAP R&D to decline low to mid single digit percentage compared to 2020 levels. This primarily reflects the timing of investments and we remind you that the expenses in both R&D and SG&A are back end loaded this year increasing sequentially from Q.

<unk> alone to Q3, and then even more from Q3 into Q4.

Our non-GAAP SG&A guidance remains unchanged.

Flat to low single digit percentage decline over 2020.

And R&D will be ramping up additional studies with the Motorola Mab <unk> long acting combination work with Atlanta cap of ear for the treatment.

2 IV and other pipeline activities and in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications such as with <unk>.

Andrew D. Dickinson: Moving to tax, we realized a lower effective tax rate of 19.6% for the quarter, or down 320 basis points year over year, due to a shift in geographic earnings mix. Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021, compared to $1.11 for the same period last year. The year-over-year improvement primarily reflects higher product sales due to VEC-LURI, higher gross margin, as well as lower operating expenses and a lower effective tax rate, offset by lower interest income.

Finally, reflecting the updates to our revenue gross margin and operating expense guidance, we now project non-GAAP diluted EPS between $6.

<unk> and <unk> 90.

<unk> per share and $7.25 per share for the year and GAAP diluted EPS between $4.70 and $5.05.

Additionally, our capital allocation priorities have not changed and we remain committed to our dividend.

Year to date, we've paid down 1 billion 1.

2.5 billion in debt and we are on track to repay at least $4 billion in debt by the end of the year.

With that 1 right the operator to begin the question and answer session.

Andrew D. Dickinson: Overall, we're encouraged by our first half results shown on slide 22. Moving to slide 23, you can see that we are updating our guidance for 2021. As always, the duration and magnitude of the COVID-19 pandemic continue to be uncertain, and the rate and degree of these pandemic impacts, as well as the corresponding recovery from the pandemic, may vary across our business. With that said, we now expect full-year total product sales in the range of $24.4 billion to $25 billion compared to our previous range of $23.7 to $25.1 billion.

Thank you as a reminder to ask a question you will need to press star 1 on your telephone sure John.

To your question press the pound key.

Joseph.

We ask that you please limit yourself to 1 question. Please standby, while we compile the Q&A roster.

Our first question comes from Cory <unk> with J P. Morgan Your line is open.

Hi, Gavin on for Cory. Thanks for taking my question just wanted to go back to the U S HIV business.

Can you provide additional color, particularly in the context of why this is so much different from the ex U S markets and what is the most important factor you'll be watching for to have confidence in the U S market normalizing. Thank you.

Andrew D. Dickinson: The new range increases the midpoint from $24.4 billion to $24.7 billion and reflects our solid results year-to-date as well as our updated expectations for the second half of the year. With first half Vecluri revenue of $2.3 billion, we now expect full year Vecluri revenue in the range of $2.7 to $3.1 billion compared to our previous $2 to $3 billion range.

Yes, Thanks, a lot Kevin for joining I'm, obviously going to turn that over to Joanna.

I just pointed out that we continue to do.

Really well and our share and certainly a bit curvy growth.

And.

<unk>.

Well positioned as the market rebounds, and with that I'll turn it over to Joana for some specifics.

Hi, Kevin.

Thanks for your question I think from a market dynamic standpoint.

What we're seeing.

We saw a little bit last year in Q2, most of the industry was actually slowing down pretty quickly in Q2, HIV took a little bit longer than it is kind of that playing out in 'twenty..1 is taking a little bit longer to come back and bounce back 1 of the major reasons for that has to do with your dynamic market being much smaller.

Andrew D. Dickinson: Our updated range reflects the ongoing role of DECLRI in this pandemic and assumes we'll continue to see regional outbreaks. The situation continues to be dynamic, and we'll likely update our thinking again when we report our earnings after the third quarter. Back to our guidance, we now expect total product sales excluding Veclurie for the year to be in the range of $21.7 billion to $21.9 billion compared to our previous range of $21.7 to $22.1 billion.

In this market you have a very large pool of patients that are just continuing patients and you're really playing in a dynamic market with your naive.

Patients coming in.

And your switches and you restart really around 5% or so and so that's why it's taking a little bit longer.

As we're going through that from a different standpoint between.

<unk> U S and Europe I think it has more to do with the fact that in Europe. There is diversity across.

Andrew D. Dickinson: This tightening of the range reflects the longer-than-expected pandemic impact on our business, including the latest increase in COVID-19 cases. As Johanna discussed, the pandemic has most notably impacted our HIV treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuations than expected in 2020. It's taking longer than we expected for treated patient volume to ramp back up to more normal levels, particularly in the United States.

Some of the different countries as to the Pandemics and the timing of.

Kind of the recoveries or even some of the searches that happen. So it's a little bit more blended than what we've seen in the U S. Thus far and so I think that's just what's playing out here obviously.

We see the bigger impact being in the U S. Because that's where most of our business lines in HIV.

And just to close out on that.

From a market standpoint, and it's very different than kind of the fundamentals of our HIV business I think what we've seen with the <unk>.

Andrew D. Dickinson: That said, we saw encouraging signs of recovery in the HIV market in the second quarter, and our guidance assumes recovery will continue through the remainder of the year. Based on market share dynamics, we remain very confident in our competitive positioning, and we believe we're well positioned as the recovery continues. Looking at the rest of our P&L, we now expect non-GAAP product gross margin in the range of 86% to 87%, reflecting a lower mix of HIV revenue.

Really quite quite pleased with in light of the fact that not only has grown quarter over.

Quarter by 1 point, both in the U S as well as in the EU 5 but also if you think about it over the last 12 months has grown 6 point share over a very strong base. We're just under 40% we're at 39% share.

At this point in time, so we're very pleased with the continued growth of victory and you can appreciate that because its such a larger base that is.

Going to get more challenging as we move forward and and Thats why.

I think we're excited about the market coming back a little bit we've seen it come back in Q2, where.

Andrew D. Dickinson: We now expect non-GAAP R&D to decline by a low to mid-single-digit percentage compared to 2020 levels. This primarily reflects the timing of investments, and we remind you that the expenses for both R&D and SG&A are back-end loaded this year, increasing sequentially from Q2 into Q3, and then even more from Q3 into Q4. Our non-GAAP SG&A guidance remains unchanged, a flat to low single-digit percentage decline over 2020. In R&D, we'll be ramping up additional studies with Megrolimab, Tredelvi, long-acting combination work with lenacapavir for the treatment of HIV, and other pipeline activities.

Where the market goes obviously, our HIV business goes because we own 75% of the market and and so therefore, we're watching that very closely but we would expect that recovery to continue.

Although at a slower pace than we had originally expected that's great John anything on the indicators.

Has there been any more on the indicators should we look at yes. So we've been looking of course at the HIV screening and diagnosis.

In.

And how that's playing out and we're still under by about 13% to below.

Covid levels. So I think once those come back up I think that would be that would be something that we're watching very closely and also the drop off rates, we talked a little bit earlier about the the.

Andrew D. Dickinson: And in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications, such as with Tredelvi and Ducardis. Finally, reflecting the updates to our revenue, gross margin, and operating expense guidance, we now project non-GAAP diluted EPS between $6.90 per share and $7.25 per share for the year, and GAAP diluted EPS between $4.70 and $5.05. Additionally, our capital allocation priorities have not changed, and we remain committed to our dividends.

The <unk> piece of the puzzle because you have.

You have less patient support groups around you have the surround sound around.

<unk> patients who have a lot of those case managers and physicians that have moved over to treat COVID-19, and so far impacting HIV a little bit disproportionately and so we're also looking at those drop off and we've seen those drop off come back to normal to pre COVID-19 levels. Just most recently and so that's another positive sign to the recovery of the market.

Andrew D. Dickinson: Year-to-date, we've paid down $1.25 billion in debt, and we're on track to repay at least $4 billion in debt by the end of the year. With that, I'll invite the operator to begin the question and answer session.

And Kevin obviously, just from a patient perspective.

And we will continue to be dedicated to helping.

Helping patients, particularly in underserved communities get back into the care system, I think thats something that Gilead prides itself on.

Operator: Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. In the interest of time, we ask that you please limit yourself to one question. Please stand by while we compile the Q&A roster. Our first question comes from Corey Kasimov with J.P. Morgan. Your line is open.

Exceptionally important as a leader in HIV medicines to make sure. We are always on the side of the patients as we as we emerge.

<unk> from this pandemic so thanks for the question Kevin.

Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Great. Thanks, so much for taking the question maybe 2 part for me first for Joanne I'm. Just wondering if you can provide any more insight on the <unk> launch specifically.

Gavin: Hi, this is Gavin on behalf of Corey. Thanks for taking our question. Just wanted to go back to the US HIV business. Can you provide additional color, particularly in the context of why this is so much different from the US markets? And what is the most important factor you'll be watching for to have confidence in the US market normalizing? Thank you. Yeah, thanks a lot, Gavin, for joining me. I'm obviously going to turn it over to Johanna.

Split of sales by either setting or indication and then for <unk> can you remind us of the size of the lung cancer cohort in tropics <unk> III and then how are you thinking about the potential risk of ILD in that population. Thank you.

Yes go ahead, John sure. Thanks for the question. So yes, so we're really pleased with HIV sales.

Sales, 24% growth quarter over quarter, I think is a very strong quarter and I think that really has to do with the approval. The second line plus approval that we got in metastatic triple negative breast cancer. Early April. It is also related to the fact that because now we have the full approval we have the opportunity to promote the incredible overall.

Daniel O'Day: I just point out that we continue to do really well in our share and certainly big revenue growth. And, you know, we are well positioned as the market rebounds. And with that, I'll turn it over to Johanna for some specifics. Thanks. Hi Gavin.

Raw survival data that we have with the ascent data and so that's been a big piece of the puzzle.

If youre asking me to split the sales per line of therapy, that's very challenging in light of the claims data that we had the debt that we have.

But what I would say if it's more about bladder.

Bladder cancer versus triple negative breast cancer, I would say most of that.

<unk> negative breast cancer, probably about a 90 day and ratio as a book.

Bladder cancer is much smaller although we've done some nice inroads there already and are looking at about.

Johanna Mercier: You have a very large pool of patients that are just continuing patients, and you're really playing in a dynamic market with your naive patients coming in, and your switches and your restarts really around 5% or so. And so that's why it's taking a little bit longer as we're going through this. From a different standpoint between the US and Europe, I think it has more to do with the fact that in Europe, there's diversity across some of the different countries as to the pandemics and the timing of the kind of recoveries or even some of the surges that happen. So it's a little bit more mixed than what we've seen in the US thus far.

Just under 10% share in bladder right now.

With <unk>, so we're excited about that as well.

No debt and then with <unk> III.

Basket study.

The <unk> per.

Arm or not.

Hard and fast.

Probably be looking at data once we get to the 2.

<unk> thousand 30 range in there, but it's not predetermined so I wouldn't want to.

Overstated.

Regarding ILD.

We are definitely <unk>.

Very sensitive to and watching for it as you can imagine.

To date, we haven't had any reports of that but.

We are ever vigilant.

Johanna Mercier: And so I think that's just what's playing out here, obviously, the bigger impact being in the US because that's where most of our business lies in HIV. And just to close out on that, that's from a market standpoint, and it's very different from the fundamentals of our HIV business. I think what we've seen with Biktarvi, we're really quite, quite pleased with in light of the fact that not only has it grown quarter by quarter by one point, both in the US as well as in the EU5, but also, if you think about it over the last 12 months, it' We're just under 40%. We're at 39% share at this point in time.

Great. Thank you both.

Thanks, Terrence will get the next question now please.

Thank you our next.

Western comes from Brian Abrahams with RBC capital markets. Your line is open.

Hey, good afternoon. Thanks for taking my question a question regarding HIV lifecycle, you recently reported data for sub Q line, a cap of share based combo in treatment naive HIV.

I'm curious how does the learnings there with respect to the resistance.

Paul Youre observing shape, how you think about the future development steps vis vis potentially exploring higher doses more frequently more frequent than every 6 months injections. Andrew are combining with agents that might have higher intrinsic barrier to resistance versus F. Tap and then I guess along the lines of HIV lifecycle I'm also curious your level of confidence as to the potential.

Johanna Mercier: So we're very pleased with the continued growth of Biktarvi. And you can appreciate that because it's such a larger base, it's going to get more challenging as we move forward. And that's why I think we're excited about the market coming back a little bit. We saw it come back in Q2.

Per cap to have exclusivity beyond 2025.

Great.

We have you start John and perhaps Andrew can comment a little bit on the on the second piece too yes. Thanks.

Very good question I think if you think about the patients in that trial. These are highly treatment experienced patients who.

Awesome.

Develop resistance because of noncompliance and win.

Johanna Mercier: Where the market goes, obviously, our HIV business goes with it, because we own 75% of the market. And so we're watching that very closely, but we would expect that recovery to continue, although at a slower pace than we had originally expected. That's great, Joanna.

These subjects are getting a sub Q injection Atlantic copper there.

Remember that these patients are going to potentially continue to go off and on their oral regimens as we think about the future.

As you know we are for treatment.

Daniel O'Day: Anything on the indicators? I think you mentioned it, is there anything more on the indicators that you'll be looking for? Yeah, so we've been looking, of course, at HIV screening and diagnosis and how that's playing out, and we're still under by about 13% to below pre-COVID levels. I think once those come back up, I think that would be something that we're watching very closely, and also the drop-off rates. We talked a little bit earlier about the adherence piece of the puzzle because you have fewer patient support groups around.

Outside of the highly treatment experienced population, we're really thinking about how we're going to combine <unk> with other long acting agents like is flat year over year.

And as we do so I think the concerns about patients potentially having.

Having.

Effective monotherapy with <unk>.

Go away in some regards right ensuring that patients are taking.

Taking multiple agents at the same time is going to be really important for us.

Thanks for debt and perhaps Andrew you want to comment on the exclusivity question for Brian.

Daniel O'Day: You have less surround sound around those HIV patients. You have a lot of those case managers and physicians that have moved over to treat COVID-19, and so it's impacting HIV a little bit disproportionately. We're also looking at those drop-offs, and we've seen those drop-offs come back to normal to pre-COVID levels just recently, and so that's another positive sign of that recovery of the market. And Gavin, obviously, just from a patient perspective, we have been and will continue to be dedicated to helping patients, particularly in underserved communities, get back into the care system.

Sure I'd be happy to hi, Brian Thanks for the question.

As you know.

There is litigation Thats underway there were some recent developments.

Number of analysts wrote about.

Our base case continues to be that there'll debt.

There'll be generics, arriving in 2025 and 2026 in the U S.

Q, respectively, but we think we have a strong case and that there.

Look forward to continuing to.

To prosecute.

Case, and we'll see where it plays out we should have an additional update later this year, so that's really where it stands.

Daniel O'Day: I think that's something that Gilead prides itself on, and it's exceptionally important as a leader in HIV medicine to make sure we are always on the side of patients as we emerge from this pandemic. So, thanks for the question, Gavin.

Thanks, Andrew can we have the next question. Please.

Thank you Andrew.

Reminder, in interest of time, we ask that you. Please limit yourself to 1 question. Our next question comes from Geoffrey Porges with SBB Leerink. Your line is open.

Operator: Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Terence Flynn: Great. Thanks so much for taking the question. Maybe two-part for me.

Thank you very much for taking the question. So just a couple of Pops in my question could you clarify a couple of your partnerships.

Operator: First, for Johanna, just wondering if you can provide any more insight on the Tredelphi launch, specifically the split of sales by either setting or indication. And then, for Merdad, can you remind us of the size of the lung cancer cohort in Tropics 3, and then how are you thinking about the potential risk of ILD in that population? Thank you. Thank you.

There's been some news from Galapagos, you've invested over $5 billion that you got to take on any of those drugs from the Toledo portfolio that the company recently highlighted and then related to that your August partnership.

Does your guidance include the upfront cost of opting in for any of those.

Johanna Mercier: Sure, thanks for the question. So, yeah, we're really pleased with the Tredelby sales. A 24% growth quarter over quarter, I think, is a very strong quarter, and I think that really has to do with the approval of the second line plus approval that we got in metastatic triple negative breast cancer early in April. It's also related to the fact that, now that we have full approval, we have the opportunity to promote the incredible overall survival data that we have with the ASCEND data.

And what's the trigger on the window for when you can opt in to any of those 3 programs because they sort of appear on your pipeline slide, but it's not completely clear whether there you know out so could you clarify.

Where you're going with those 2 partnerships.

Sure Jeff. Thank you very much for the question I'll start.

Start a little bit and then ask.

Andrew if you want to add anything as well so I think first and foremost I think we are.

We believe deeply in partnerships.

Have a robust internal portfolio and we also as you know a design these opt ins as a way to expand our portfolio and different things.

Johanna Mercier: And so that's been a big piece of the puzzle. If you're asking me to split the sales per line of therapy, that's very challenging in light of the claims data that we have. But what I would say, if it's more about, you know, bladder cancer versus triple negative breast cancer, I would say most of that is triple negative breast cancer, probably about a 90 to 10 ratio as our bladder cancer is much smaller.

Deputed, Gary starting with Galapagos as you know, which is predominantly focused on inflammation.

At this stage.

We don't have any opt in.

Milestones right now with Galapagos, we are working closely with them on their science and their discovery platform.

Some of their preclinical to clinical molecules.

To support them in their efforts, but at this stage.

We don't have anything more to reported other than might Galapagos is reported on the Princeton to Geoff to your question on the Toledo program, but rest assured that as those programs evolve and mature and develop.

Johanna Mercier: Although we've made some nice inroads there already and are looking at about just under 10% share in the bladder right now with Tredelby, so we're excited about that as well. And then with Tropics 3, it's a basket study, so the ends per arm are not, you know, hard and fast.

We will keep you informed perhaps more debt if you won't see anything else in Galapagos from.

Yeah, I think I think the stories are similar that we like to keep.

You apprised of what could potentially come into our portfolio and we have opt in rights to.

Merdad V. Parsey: We'll probably be looking at data once we get to the, you know, the 20-30 range in there, but it's not predetermined, so, you know, I wouldn't want to overstate it. Regarding ILD, we are definitely very sensitive to and watching for it, as you can imagine. To date, we haven't had any reports of that, but we're ever-vigilant.

For <unk> I mean I think.

Dan laid out Galapagos well for ARCUS, we continue to wait for data to mature.

Sure.

Once a day to get to a level of maturity, where we can really make the call.

That's when we will have our.

Our opt in we have not included in a book.

Andrew will confirm for me, but we have not included the financials.

Operator: Great. Thank you both. Thanks, Terence. We'll get the next question now.

Potential opt in in our guidance at this point.

Andy.

Correct, yes.

Yes, no I'm happy to follow up here, Jeff Good question.

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

Nothing has changed from the guidance at the beginning of the year. So our R&D spend and all of our expense guidance does not include the opt ins on any of the programs that we have options to including the 3 programs that you mentioned debt at arc as you also asked about the opt in.

Operator: Hey, good afternoon. Thanks for taking my question. A question regarding the HIV life cycle. You recently reported data for a sub-Q-Lenacapavir-based combo in the treatment of HIV. I'm curious, how do the learnings there with respect to the resistance profile you're observing shape how you think about the future development steps vis-à-vis potentially exploring higher doses, more frequently, more frequent than every six months injections, and or combining with agents that might have higher intrinsic barrier resistance versus FTAF?

It's the.

The opt in window for the first digit antibody.

Should be coming most likely at the end of this year. It could be early next year, but it's most likely at the end of this year, we'll have enough patient data.

To trigger the opt in or our desire to opt into potentially early on.

On the other 2 programs the identity and program.

Window, because thats, most likely next year and again there may be additional data that comes this year.

It looks really strong.

Want to move as quickly as we can and we can opt in early Jeff on those programs and then on Toledo, It's relatively simple and all of that Galapagos programs. The opt in comes after phase 2 enabling studies. So that suite of programs are a long ways away from.

Operator: And then, along the lines of the HIV life cycle, I'm also curious about your level of confidence as to the potential of FTAF to have exclusivity beyond 2025. Great. Why don't we have you start, Merdad, and perhaps Andy can comment a little bit on the second piece, too? Yeah, thanks. It's a very good question.

Graham that are a potential opt in decision.

Phase III, enabling.

Yeah, I'm, sorry phase III, enabling thank you.

Alright.

John just I'll, just kind of round out your question I mean, there's obviously many other partnerships we have that we're working closely with different phases, but those are the specific ones you're asked about thank.

Merdad V. Parsey: I think if you think about the patients in that trial, these are highly treatment-experienced patients who often develop resistance because of noncompliance. And when these subjects are getting a sub-Q injection, Lenacapravir, remember that these patients are going to potentially continue to go off and on their oral regimen. As we think about the future, as you know, we are, for treatment, going outside the highly-treatment-experienced population; we're really thinking about how we're going to combine Lenacapazir with other long-acting agents like Isflatributin.

Thank you very much for the question can we have the next question. Please.

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

Great afternoon, guys. Thanks for taking my questions a question for Dan or our merchandise more debt on Covid, There's a high expectation that vaccines are here for a.

I'll now that the Delta variant is is it really changed the dynamic. The question is has the strategic value of victory changed for you guys. As new cases have ticked up I know you decided not to pursue inhaled but is there.

Merdad V. Parsey: And as we do so, I think the concerns about patients potentially having effective monotherapy with lenacapavir go away in some respects, right? Ensuring that patients are taking multiple agents at the same time is going to be really important for us.

Life cycle here worth investing in over the long term. Thank you.

Thanks, Jeff I'll start and then.

I believe the correct me or add.

<unk> do it but I think.

Just to emphasize.

Merdad V. Parsey: Thanks, Merdad. And perhaps, Andy, you want to comment on the exclusivity question for Brian? Sure. I'd be happy to. Hi, Brian.

The importance of Gilead legacy and anti Virals, and frankly, our strength and that to us as well so.

Andrew D. Dickinson: Thanks for the question. As you know, there is litigation that's ongoing. There were some recent developments that a number of analysts wrote about. You know, our base case continues to be that there'll be generics arriving in 2025 and 2026 in the U.S. and EU, respectively. But we think we have a strong case and that we look forward to continuing to prosecute the case. And we'll see where it plays out. We should have an additional update later this year. So that's really where it stands. Thanks, Annie. Can we have the next question, please?

Being of course, the first company to have.

While in the only company to have an approved anti viral for.

For Covid. It is no accident, obviously has decades of experience decades of investments in a variety of emerging viruses, including Covid and we haven't stopped so.

To your point, Jeff, but I think we're all learning about this pandemic as it rolls out.

And it certainly.

Going through different phases, and where we think we'll continue to grow through different phases.

And therefore, we are.

If you like kind of doubling down on an ability to think about antivirals outside the hospital setting where around distributor plays such an important role and maybe with that I'll hand, it over number debt.

Operator: Thank you. As a reminder, in the interest of time, we ask that you please limit yourself to one question. Our next question comes from Jeffrey Porges with SBB Link. Your line is open.

As a clinician.

And how you might also Steve so to answer the debt net of given also our role in it yes. Thanks.

We have I think pretty been pretty consistently of the mindset that.

Jeffrey Porges: Thank you very much for taking the question. So, there are just a couple of parts to my question.

<unk>.

The vaccines will will make.

Tremendous impact.

Operator: Could you clarify a couple of your partnerships? There's been some news from Galapagos. You've invested over $5 billion there.

The case numbers in.

Those sorts of things.

Even though I think it even when we get to some sort of equilibrium. Unfortunately, they will continue to be we believe infections people will continue to get infected and some proportion of those patients will end up in the hospital.

Jeffrey Porges: Are you going to take on any of those drugs from the Toledo portfolio that the company recently highlighted? And then, related to that, your Arcus partnership, does your guidance include the upfront cost of opting in for any of those programs? And what's the trigger and the window for when you can opt in to any of those three programs? Because they sort of appear on your pipeline slide, but it's not completely clear whether they're in or out. So, could you clarify where you're going with those two partnerships? Sure, Geoff.

So.

We do believe that the cleary in the hospitalized.

Life setting is.

Is it going to be continue to be really important for treating those patients and as Dan alluded to we continue to believe in <unk>.

We're committed to.

Daniel O'Day: Thank you very much for the question. I'll start with a little bit and then ask Merdad and Andy if they want to add anything as well. So, first and foremost, I think we're, you know, we believe deeply in partnerships. We have a robust internal portfolio, and we also, as you know, have designed these opt-ins as a way to expand our portfolio in different therapeutic areas, starting with Galapagos, which is predominantly focused on inflammation.

Treatments, making treatments available in the outpatient setting.

So I wouldn't.

No.

The inhaled <unk>.

<unk> approach it didn't give us the results we were hoping for the consistency we were looking for but because we have other agents in our pipeline based on our neurology expertise, we will be bringing those forward and and really focusing on the outpatient setting there. So.

<unk> continue to believe that.

Daniel O'Day: You know, at this stage, we don't have any opt-in milestones right now with Galapagos. We're working closely with them on their science and their discovery platform and some of their preclinical to clinical molecules to support them in their efforts.

Having a treatment available for people.

Whether they are vaccinated or not is going to be important for the foreseeable future.

And Jeff what I might add.

Our preclinical folks continue to study.

Industrial here against the variety of variance in fact, all 4 major variance of concerns.

The output from the UK to the data from South Africa to gamma from Brazil, and the Delta from India.

And all are fully sensitive.

Against.

Sure.

Industrial is a sensitive against all those strange 1.

Sure It makes sense, because we're not seeing any mutations in the preliminary.

<unk> run debt severe binding site.

So I think it's important as we think about next generation products to also think about medicines that.

Merdad V. Parsey: We like to keep you apprised of what could potentially come into our portfolio, and we have the opt-in rights, too. For Arcus, I mean, I think Dan laid out Galapagos well. For Arcus, we continue to wait for data to mature, and once the data get to a level of maturity where we can really make the call, that's when we'll have our opt-in. We have not included, and Andy will confirm for me, but we have not included the financials of a potential opt-in in our guidance at this point. That's correct.

Will.

Be effective against these ongoing variants microphone debt severe it's an important bar for us as we move forward.

Thanks, John for the question.

Thank you. Our next question comes from Omar Saad with Evercore. Your line is open.

Hi, guys. Thanks for taking my question I had 2 quick ones as well first have you had an interim PFS on the HR positive study of <unk>.

Andrew D. Dickinson: Yeah, and I'm happy to follow up here, Geoff, good question, and nothing has changed from the guidance at the beginning of the year, so our R&D spend and all of our expense guidance do not include the opt-ins on any of the programs that we have options for, including the three programs that you mentioned at Arcus. You also asked about the opt-in windows. The opt-in window for the first-digit antibody should be coming most likely at the end of this year.

And secondly.

Congrats.

Grossman's higher for Marcus and I was wondering to what extent was the decision to build bring onboard driven exclusively by build familiarity with ARCUS programs. Thank you very much.

Yes sure.

Thanks Robert.

Great question, Yes, we have not done the.

On BFS analysis, as we've talked about that that will happen.

Certainly before the end of the year, we hope.

Andrew D. Dickinson: It could be early next year, but it's most likely that at the end of this year, we'll have enough patient data to trigger the opt-in or our desire to opt-in potentially early. On the other two programs, the Adenosine programs at Arcus, that's most likely next year, and again, there may be additional data that comes this year, but if it looks really strong, we want to move as quickly as we can, and we can opt-in early, Geoff, on those programs. And then on Toledo, it's relatively simple.

And.

That's still what we're tracking to but we have not done the analysis yet.

So we remain blinded to those data and then in terms of bill.

I think.

Yes.

I wouldn't necessarily tie it as is.

Youre, suggesting to ARCUS, it's certainly an advantage for us that should we opt into ARCUS programs Bill will bring familiarity but.

For us Bill his experience and leadership.

Operator: On all of the Galapagos programs, the opt-in comes after Phase II enabling studies, so the Toledo programs are a long ways away from a potential opt-in decision. Okay, page three. Yeah, I'm sorry, phase 3 enabled, thank you. Geoff, I just kind of round out your question. I mean, obviously, there are many other partnerships we have that we're working closely with at different phases, but those are the specific ones you asked about. Thank you very much for the question. Can we have the next question?

And his excitement about being here.

Acting overall portfolio were the drivers for bill coming on board.

Just to add humor.

Many of US know Bill <unk>.

Well.

Our relationship.

With ARCUS is extremely important and continues to be and this was an example of bill.

Seeing a career opportunity.

And overseas evolution for his career that made sense for him.

We certainly want to make sure that.

<unk> continues to.

We have the skill set that it needs to be successful rehab the skill set that we need to be successful I think.

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

It's just a good example of.

Our partners collaborate a time soon so.

Operator: Great afternoon guys, thanks for taking the question. A question for Dan or Merdad on COVID, you know there's a high expectation that vaccines are here for a while now that the Delta variant has really changed the dynamic. The question is, has the strategic value of Veclary changed for you guys as new cases have picked up? I know you decided not to pursue Inhale, but is there, you know, a life cycle here worth investing in over the long term? Thank you. Thanks, Jeff.

<unk> I just wanted to emphasize our relationship with ARCUS is unchanged and as strong as ever.

Thank you.

Yeah.

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

Hey, Thanks for the question I appreciate it maybe a question for.

I would add on <unk>.

Parts.

In the tropics <unk> study you had the smart decision to take a look at that enlarge it powered for PFS et cetera did you have any information that could help give you confidence around the powering and any information that would help you give confidence in your overall study such as the.

Daniel O'Day: I'll start and then Merdad will either correct me or add more information to it. But I think, I mean, just to emphasize the importance of Gilead's legacy in antivirals and, frankly, our strength in that too, to us as well. So, you know, being, of course, the first company to have, and the only company to have an approved antiviral for COVID is no accident. Obviously, it's decades of experience, and decades of investments in a variety of emerging viruses, including COVID. And we haven't stopped.

More events that have passed or anything like that or even knowing that it had passed the futility. If you could even comment on that and then on the lung data that's coming up can you just comment around your belief in the profile versus the competitor similar efficacy better safety or how should we interpret that data when it comes later this year. Thank you.

Nice to.

Hear your voice Michael over the year, yes, Thanks, Michael.

Merdad V. Parsey: So, you know, to your point, Jeff, I think we're all learning about this pandemic as it rolls out. And it's certainly, you know, going through different phases, and we think we'll continue to go through different phases. And therefore, we are, if you like, kind of doubling down on an ability to think about antivirals outside the hospital setting, where remdesivir plays such an important role. And maybe with that, I'll hand it over to Merdad, as a clinician, how you might also see the future of the pandemic and then also our role in it. Yeah, thanks.

On the tropics <unk> study.

John.

We have not done a futility analysis.

We are.

We are we continue to look to those data maturing and getting getting the number of events that we need for.

For for the PFS analysis that we have planned.

We're pretty confident in our powering and in particular since we expanded the sample size to make sure that we are able to hit.

The PFS endpoint of course relevant issue is.

The duration of PFS that we get but from a powering standpoint.

Merdad V. Parsey: I think we have consistently been of the mindset that the vaccines will make a tremendous impact on the case numbers and those sorts of things. Even though, I think, even when we get to some sort of equilibrium, unfortunately, there will continue to be, we believe, infections. People will continue to get infected, and some proportion of those patients will end up in So, we do believe that the glory in the hospitalized setting is going to continue to be really important for treating those patients, and as Dan alluded to, we continue to believe in and are committed to making treatments available in the outpatient setting.

We're comfortable.

And it's just a matter of seeing those data from an ongoing event standpoint.

We are where we thought we would be at this point and it's really around just letting the events.

Come in make sure they get adjudicated.

Clean the data and time to do the analysis properly. So that's where we are with that and then.

In terms of the lung data.

On efficacy.

Yes, I mean, I think as I think we've said before we.

More proceeding.

At risk in pretty aggressively partly based on our belief in the drug partly because of what what we've seen with other agents.

In lung.

And partly based on our early data that youre familiar with in lung.

We've seen of course, we want.

Want to make those data more robust.

We go into the phase III World. So we are going to augment our existing data to make sure that we are we are.

Daniel O'Day: So we continue to believe that having a treatment available for people, whether they're vaccinated or not, is going to be important for the foreseeable future. And, Geoff, what I might add is that, you know, our preclinical folks continue to study remdesivir against a variety of variants. In fact, all four major variants of concern, so the alpha from the UK, the beta from South Africa, the gamma from Brazil, and the delta from India, and all are fully sensitive, you know, against, or remdesivir is as sensitive against all those strains, which would make sense because we're not seeing any mutations in the polymerase remdesivir binding site.

Mitigating our risk somewhat but.

Thus far I think what we are hoping for is efficacy.

<unk>.

We're really really is comparable to.

What the benchmark might be.

Even though I think.

Too early to say what that benchmark is with debt with a direct competitor, but we are again I think confident about our ability to bring safety profile that that hopefully will be better for patients.

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

Thank you. Our next question comes from Alethia Young with Cantor Your line is open.

Hey, guys. Thanks for taking my question I'm, just curious about again going back to the ARCUS collaboration with arc 7 how did you think about what the hurdle is for a trip Paul do you think that it has to be more than Mike.

Daniel O'Day: And so I think it's important as we think about, you know, next-generation products to also think about medicines that will be effective against these ongoing variants like remdesivir. It's an important bar for us as we move forward. Thanks, Geoff, for the question.

Some of the competitors like Roche happened in double thanks.

Thanks Lee.

I think we have the luxury of being able to look at the single a doublet.

Triple here.

We would be of course excited if the triplet differentiates from the doublet and provides.

Operator: Thank you. Our next question comes from Umer Raffat with Evercore. Your line is open. Hi guys, thank you for my question.

Efficacy that I think that's what we'd be looking for.

And so as the data mature looking for.

Umer Raffat: I had two quick ones as well.

Operator: I had two quick ones as well. First, have you had an interim PFS on the H.R. positive? And secondly, congratulations on Bill Grossman. And I was wondering, to what extent was the decision to bring Bill Grossman on board driven exclusively by Bill's familiarity with ARCIS programs? Thank you very much.

Some signals.

A reason to believe that the triplet is performing.

More robustly than the doublet is probably going to be our focus we'd be very excited.

Better plays out it gives us.

A pretty unique position.

Thanks to the EPS. So I think we have time for 1 more question and thanks, everybody for your enrolment and the last question. Please.

Merdad V. Parsey: Yeah, why don't you start Merdad? Yeah, thanks, thanks Umer. Great questions. Yeah, we have not done the interim PFS analysis as we've talked about. That'll happen certainly before the end of the year, we hope. And that's still what we're tracking too, but we have not done the analysis yet. So we remain blinded to the data.

Thank you Andrew.

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

Hi, everybody and thanks for squeezing me in a question about the projections for HIV for the next couple of years.

Part 1 I guess as you change your reimbursement policy on 340 clinics next year.

Essentially was is that difference in terms of what it creates for you and we won't Pls would it appear on revenue on SG&A in.

Merdad V. Parsey: And then in terms of Bill, you know, I think I wouldn't necessarily tie it, as you're suggesting, to ARCIS. It's certainly an advantage for us that should we opt in to ARCIS programs, Bill will bring familiarity. But for us, Bill's experience and leadership and his excitement about being here and overseeing the overall portfolio were the drivers for Bill coming on board. Yeah, and I would just add, Umer, I mean, look, many of us know Bill; you know him as well.

And the second 1 you already mentioned the prep.

Barriers are dropping with preventative treatment designation for prep.

I can't figure out if this is good or bad for you from the perspective of branded drug adoption, giving that day.

Don't have to cover branded drugs.

Thanks.

So over to you Joanna share Ronny I'm, assuming you're talking about the patient assistance program changes correct.

Merdad V. Parsey: Our relationship with ARCIS is extremely important and continues to be, and this was an example of Bill seeing a career opportunity and seeing an evolution of his career that made sense for him. We certainly want to make sure that ARCIS continues to have the skillset that it needs to be successful. We have the skillset that we need to be successful. I think it's just a good example of how partners collaborate at times. And so I just wanted to emphasize that our relationship with ARCIS is unchanged and as strong as ever.

So I wanted to differentiate that those are at 340 <unk> changes that's actually a program that's really in line with our commitment to help end the HIV epidemic.

To date the program is actually provided free drive.

250000 individuals.

And really that's what it is it's a free program that was always intended and we will continue to provide a gilead medication to eligible individuals to treat and prevent HIV. Unfortunately, it was not intended to be a source of funding for organizations to deliver services and that's what we're trying to.

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

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

Operator: Maybe a question for Merdad on Tredelvi, a couple parts. In the Tropics II study, you had the smart decision to take a look at that, enlarge it, power it for PFS, etc. Did you have any information that could help give you confidence around the powering and any information that would help you give confidence in your overall study, such as the number of events that have passed or anything like that, or even knowing that it had passed a futility, if you could even comment on that?

2 more that Kevin.

We set a little bit so the changes to our program model will pass we will protect our ability to be able to do this in the longer term and make it a sustainable program and for us and more importantly for patients. So that's the patient assistance program on that front.

And the question Youre asking me about perhaps.

So quite encouraged.

<unk> and <unk>.

The 2 that came out from the U S at PST.

And here's why in the FHA they provide a lot more clarity than they had in the past right. This isn't new the recommendation actually came out a portable care Act recommendation came out 2 years ago.

Operator: And then on the long data that's coming up, can you just comment on your belief in the profile versus the competitor? Is it similar efficacy, better safety, or how should we interpret that data when it comes later this year? Nice to hear your voice, Michael. Over to you, Merdad.

But what this provided was actually.

<unk> weighted more details to add and clarity on the importance of prep and ending the epidemic.

Merdad V. Parsey: Yeah, thanks, Michael. On the Tropics II study, you know, we have not done a futility analysis. We are, We continue to look at these data maturing and getting the number of events that we need for the PFS analysis that we have planned. We're pretty confident in our powering, and in particular, since we expanded the sample size to make sure that we are able to hit the PFS endpoint. Of course, the relevant issue is more the duration of the PFS that we get, but from a powering standpoint, we're comfortable, and it's just a matter of seeing the data.

And minimizing the barriers of use and Theres a couple of things in the Q that pop out for me..1 is it truly supports physician and patient choice and that's the piece where generics are non generics right. So <unk>.

<unk> generics or disco V would then need to be.

Really the physicians and the patients get to decide together what is the right medicine for which patients and of course with the bone and renal safety.

The benefits that <unk> brings I think this is a great addition to the Faq's in addition.

Merdad V. Parsey: From an ongoing event standpoint, I think we are where we thought we would be at this point, and it's really around just letting the events come in, make sure they get adjudicated, and we clean the data in time to do the analysis properly, so that's where we are with that. In terms of the lung data on efficacy, yeah, I mean, as I think we've said before, we're really proceeding, you know, somewhat at risk and pretty aggressively, partly based on our belief in the drug, partly because of what we've seen with other agents in the lung, and partly based on our early data that you're familiar with in the lung that we've seen.

That there is also some guidance around timely management.

On the.

The request for this by payers so to turn it around within 24 hours, which is quite different than what's happening today and then the last piece is $0 of out of pocket costs. So I think for patients.

<unk>. This is great news and I also think for patient choice and physician choice. This is quite promising as well.

Ronny I want to make sure we covered your question.

Merdad V. Parsey: Of course, we want to make those data more robust while we go into the Phase III world. So we are going to augment our existing data to make sure that we are mitigating our risk somewhat. But thus far, I think what we are hoping for is efficacy that is certainly comparable to what the benchmark might be, even though I think it's too early to say what that benchmark is with the direct competitor. But we are, again, I think, confident about our ability to bring a safety profile that hopefully will be better for patients.

Did I understand you correctly.

Okay.

So robin.

Additionally, as well.

Well, thank you all very much.

Yes.

So 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.

[music].

Great.

Okay.

[music].

Operator: Excellent. Thank you, Michael. Can we have the next question? Thank you. Our next question comes from Alicia Young with Canthor. Your line is open.

Alicia Young: Thank you. Our next question comes from Alicia Young with Canthor. Your line is open.

Merdad V. Parsey: You know, I think we have the luxury of being able to look at the singlet, a doublet, and a triplet here. We would be, of course, excited if the triplet differentiates from the doublet and provides better efficacy. I think that's what we'd be looking for. And so, as the data mature, looking for some signals, a reason to believe that the triplet is performing more robustly than the doublet, is probably going to be our focus. We'd be very excited if that plays out and gives us, I think, a pretty unique position.

Operator: Thanks, Alicia. So, I think we have time for one more question, and thanks, everybody, for your involvement. So, the last question, please.

Operator: Thank you. And the last question comes from Ronnie Gallagher Bernstein. Your line is open. Hi, everybody, and thanks for squeezing me in.

Ronnie Gallagher: Hi, everybody, and thanks for squeezing me in. A question about the projections for HIV for the next couple of years. Part one, I guess, is that you change your reimbursement policy on 340B clinics next year. How big, essentially, is that difference in terms of what it creates for you, and where on PLL will it appear on revenue or on SG&A?

Operator: And the second one, you already mentioned the PrEP barriers are dropping with preventative treatment designation for PrEP. I can't figure out if this is good or bad for you from the perspective of branded drug adoption, given that they don't have to cover branded drugs. Thanks, Ronnie. Now, over to you, Johanna.

Johanna Mercier: Sure. Ronnie, I'm assuming you're talking about the Patient Assistance Program changes? Correct. Okay.

Johanna Mercier: So I want to differentiate that. Those aren't 340B changes. That's actually a program that's really in line with our commitment to help end the HIV epidemic. To date, the program has provided free drugs to more than 250,000 individuals. And really, that's what it is. It's a free program that was always intended and will continue to provide free Gilead medication to eligible individuals to treat and prevent HIV. Unfortunately, it was not intended to be a source of funding for organizations to deliver services.

Johanna Mercier: And that's what we're trying to reset a little bit. So the changes to our program model will protect our ability to be able to do this in the longer term and make it a sustainable program for us and, more importantly, for patients. So that's the Patient Assistance Program on that front. The question you were asking me about PrEP, we're actually quite encouraged by the FAQ that came out from the USPSTF. And here's why. In the FAQ, they provide a lot more clarity than they have in the past. This isn't new.

Johanna Mercier: The recommendation actually came out, the Affordable Care Act recommendation came out two years ago, but what this provided was actually more details on it and clarity on the importance of PrEP in ending the epidemic and minimizing the barriers of use. And there's a couple of things in the FAQ that pop out for me. One is that it truly supports physician and patient choice. And that's the piece where generics or non-generics, so Travada generics or DSCOVI, would then need to be really physicians and patients get to decide together what is the right medicine for which patient.

Johanna Mercier: And, of course, with the bone and renal safety benefits that DSCOVI brings, I think this is a great addition to the FAQs. In addition to that, there's also some guidance around timely management of the request for this by payers. So to turn it around within 24 hours, which is quite different than what's happening today. And then the last piece is $0 in out-of-pocket costs. So I think for patients, this is great news, and I also think for patient choice and physician choice, this is quite promising as well.

Johanna Mercier: Ronnie, I want to make sure we covered your question. Did we understand you correctly? I assume so, Ronnie.

Operator: Great. Well, thank you all very much. So, 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. BF-WATCH TV 2021,,,,,,,,,,,,,,,,,,,, Thanks for watching!

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. ??? [inaudible] Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Good day and thank you for standing by. Welcome to the Gilead Sciences second quarter 2021 earnings conference call.

[music].

Jacquie Ross: After that, we'll open up the call to Q&A, where the team will be joined by Christy Shaw, the Chief Executive Officer of KITE. Before we get started, let me remind you that we will be making forward-looking statements, including those related to the impact of the COVID-19 pandemic on Gilead's business, financial condition and results of operation, plans and expectations with respect to products, product candidates, corporate strategy, financial projections and the use of capital, and 2021 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

Jacquie Ross: The gap to non-GAAP reconciliations are provided in the earnings press release and in our supplementary data sheet, as well as on the Gilead website. I will now turn the call over to Dan. Thank you, Jacquie, and good afternoon, everyone. Thanks for taking the time to join us here today. We're pleased to provide you with an update on our second quarter, where we delivered solid financial performance and significant progress in our increasingly diverse pipeline.

Jacquie Ross: 2021 is an important year for our pipeline, and we're very encouraged by the milestones we've achieved for therapies that are potentially transformative for Gilead and for patients. All of this reinforces our confidence in our strategic direction.

Daniel O'Day: Turning to the main highlights of the quarter on slide four, the second quarter was a solid quarter overall, but glory sales of $829 million were once again higher than anticipated, offsetting the lingering impact of the pandemic, particularly on HIV treatment. In light of this pandemic impact, Biktarvi's performance is quite encouraging. Revenue for the quarter was $2 billion U.S. dollars, up 24 percent, or $390 million from the same quarter last year. This more than offset the $322 million headwind associated with the impact of the Truvada and Atripla LOEs. Much of that headwind is now, of course, behind us.

Good day and thank you for standing by welcome to the Gilead Sciences second quarter 2021earnings conference.

Paul at this time, all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session ask a question. During the session you will need the pets star 1 on your telephone please be advised that today's conference is being recorded.

We acquire any further assistance please press.

Star Zero I would now like to hand, the conference over to your speaker today, Jackie Roth VP Investor Relations. Please go ahead.

Thank you Joelle and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the second quarter 2021, the press release slides and supplementary data are available.

Since the investors section of our website at Gilead dotcom.

The speakers on today's call will be our chairman and Chief Executive Officer, Daniel or day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Murdoch per Se and our Chief Financial Officer, Andrew Dickinson after that well open up the call to Q&A, where the team will be joined by Christi Shaw.

Daniel O'Day: This is truly a landmark trial, the first and largest reported Phase III trial readout that demonstrates the efficacy and safety of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier life. We shared positive Phase III data from MIR-301, which will help support our anticipated BLA filing for hapleutics for HDV in the U.S. later this year. And we submitted our NDA for use of lenacapavir in the heavily treatment-experienced population with multidrug resistance. This filing was based on data from the Phase 2-3 Capella Study presented earlier this month.

Sure the Chief Executive Officer of Kate.

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

Daniel O'Day: We also shared strong Lenacapivir data from the Phase 2 Calibrate study in HIV treatment, which will be used to inform our broader Lenacapivir effort. Our partner, AHRQ, has provided an interim update from AHRQ 7 that supports the continuation of both AHRQ 7 and AHRQ 10 trials for their anti-tissue candidate, Dumb Vanilla Mabs. Lastly, on slide four, we're beginning to see the positive impact of our strategy, which we introduced early last year.

Available on financial projections, and the use of capital and 2021 financial guidance all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

A description of these risks can be found in the earnings press release and our latest.

SEC disclosure documents.

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

Daniel O'Day: The business is diversifying across indications and therapies. In particular, we are seeing cell therapy and Tridel V contribute to growth, and we expect they will be key growth drivers for Gilead. While we build out the oncology business, we remain focused and committed to ensuring the long-term competitive positioning of our virology portfolio. Next, on slide five, we highlighted our pipeline execution so far this year, and I'd like to thank all those who helped us to deliver on this ambitious agenda, including our employees, the people who participated in the studies, our partners, and the study investigators.

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

A GAAP to non-GAAP reconciliations are.

James did in the earnings press release, and our supplemental data sheet as well as on the Gilead website.

I will now turn the call over to Dan.

Thank you Jackie and good afternoon, everyone. Thanks for taking the time to join US here today. We are pleased to provide you with an update on our second quarter, where we delivered solid financial performance.

Daniel O'Day: As we look ahead to the rest of the year, our target milestones include a progression-free survival or PFS readout in our event-driven Phase III Tropics II study evaluating TRODELV in hormone receptor HER2-positive negative metastatic breast cancer, a Phase 1b readout from Agrolimab and Myelodysplastic Syndrome or MDS. Depending on the data, timing, and results, this could result in a BLA submission for accelerated approval and the initiation of the potential phase 3 Lenacapivir and Aslatrevir long-acting oral combination. As you know, this is in collaboration with Merck, and the development and formulation work remain on track. We look forward to updating you next quarter about the additional milestone progress.

It provides a good progress on our increasingly diverse pipeline.

2021 is an important year for our pipeline and we're very encouraged by the milestones we've achieved for therapies that are potentially transformative for gilead and per patients.

All of this reinforces our confidence in our strategic direction.

Ill take this opportunity to thank our global community of Gilead, and kite employees, who consistently go above and beyond to drive progress with resilience and dedication day.

Parts of the World are riding the ebb and flow of COVID-19 cases at various times and while the vaccines give us hope and optimism we are still very.

Very much living with the pandemic.

<unk> continues to play an important role in fighting the virus and has now been used to treat an estimated 7 million hospitalized patients worldwide.

Turning to the main highlights of the quarter on slide 4 the second quarter was a solid quarter overall thanks.

Daniel O'Day: We understand the continued strong and consistent pipeline execution is critical to extending the virology business and expanding further into oncology. We believe our current and pipeline therapies can address significant unmet medical needs. We are very encouraged by the progress Gilead and Kite are making. We are well on our way in our journey to expand and diversify in new therapeutic areas. And we are already seeing the evolution of both our pipeline and our commercial portfolio. With that, I'll hand over to Johanna, who will share an update on our commercial performance for the second quarter. Thanks, Dan, and good afternoon, everyone.

Thanks, Laura sales of $829 million were once again higher than anticipated offsetting the lingering impact of the pandemic, particularly on HIV treatment.

In light of this pandemic impact <unk> performance is quite encouraging revenue for the quarter was 2 billion us dollars up 20.

4% or $390 million from the same quarter last year.

This more than offset the $322 million headwind associated with the impact of the truvada in a triplet eloise.

Much of that headwind is now of course behind us.

Overall our.

Share of the HIV treatment, Mark had held steady quarter over quarter and or perhaps share remained steady even with generic entries. These dynamics give us confidence that the underlying demand for our HIV products remains strong and positions us well for growth as the overall HIV market recovery gains momentum.

Johanna Mercier: Starting on slide 7, total product sales of $6.2 billion were up 21% year-over-year, primarily reflecting Vicklery, which was not a contributor to revenue in the second quarter of 2020. On slide 8, Clery second-quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection and hospitalization in many regions. While hospitalizations trended lower in the second quarter, the glory remained the therapy of choice in three out of five patients hospitalized with COVID-19.

Moving to our clinical pipeline 2021, as a catalyst to every year for Gilead and we've delivered all of our key first half pipeline commitments.

Among other milestones we shared top line data from the highly anticipated Zuma 7 trial, where he is skarda improved event free survival.

A viable for second line large b cell lymphoma, or <unk> patients by 60% compared to the standard of care.

Johanna Mercier: We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with remdesivir. It's truly remarkable and encouraging to see how remdesivir continues to play such a key role in fighting this global pandemic. Excluding VetGlory, total product sales of $5.3 billion were up 5% year-over-year.

This is truly a landmark trial, the first and largest reported phase III trial, readouts that demonstrates the efficacy and safety of cell therapy, and we are excited by.

Turning to bring the potential benefits of cell therapy to patients in earlier lines.

We shared positive phase III data from mirror, 301, which will help support our anticipated BLA filing for <unk> for H D. B in the U S. Later this year and we.

Johanna Mercier: We saw growth in cell therapy and HCV in addition to new revenue contributions from Tredelvi and, more modestly, Hep Cludex for HDV. Additionally, other product revenues of $291 million grew 20% year-over-year, driven by increased demand for ambazone outside of the U.S. to treat mucormycosis, which has seen a rise in incidence in patients hospitalized with COVID-19. sequentially, we saw 9% growth in total product sales, excluding Veclari, primarily driven by growth in Victarbi.

The <unk> NDA for use of <unk> in the heavily treatment experienced population with multi drug resistance.

This filing was based on data from the Phase III 3 Capella study presented earlier this month.

We also shared strong learner cap of your data from the phase II calibrate study in HIV.

Submitted in which will be used to inform our broader Atlantic half of your efforts.

Our partner ARCUS provided an interim update from arc 7 that supports the continuation of both <unk> and <unk> trials for their anti <unk> candidate John Vanilla Mab.

Lastly on slide 4 we are beginning.

To see the positive impact of our strategy, which we introduced early last year.

Johanna Mercier: Moving to slide 9, HIV product sales were $3.9 billion, up 8% sequentially, and down 2% year over year. Compared to the second quarter of 2020, total HIV revenue reflected strong big tariff growth that more than offset the $322 million lower revenue from Truvada and Atripla following their loss of exclusivity. Compared to last quarter, HIV grew by 288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment. Victory revenue of $2 billion was up 24% year-over-year and 9% sequentially, with quarter-over-quarter growth primarily driven by increased demand.

The business is diversifying across indications and therapies in particular, we are seeing cell therapy, and <unk> contribute to growth and expect they will be key growth drivers for gilead.

While we build out the oncology business, we remained focused and committed.

Uninsured the long term competitive positioning of our virology portfolio.

Next on slide 5 we highlighted our pipeline execution. So far this year and I'd like to thank all those who helped us to deliver on this ambitious agenda, including our employees the people who participated in our studies.

Our partners in the study investigators.

Patrick breast cancer.

Johanna Mercier: Viterbi remains the number one prescribed therapy in the U.S. across naive, switch, and continuing patients and remains number one in naive across all EU5 countries. Additionally, approximately 70% of switches from both Gilead and non-Gilead regimens result in incremental revenue. Overall, and despite the ongoing impact of the pandemic, Biktarvi continues to gain market share with 1% share growth versus last quarter in both the U.S. and the E.U. Discovey revenues of $435 million grew 21% sequentially due to modest improvement in the demand for PrEP and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first.

Our phase <unk> readout from our goal amount, then Michael Dysplastic syndrome, or Mds <unk>.

On the data timing and results. This could result in a BLA submission for accelerated approval.

And initiation of the potential phase III Atlantic <unk> long acting oral.

Combination.

As you know this is in collaboration with Merck and the development and formulation work remains on track.

We look forward to updating you next quarter about the additional milestone progress.

We understand the continued strong and consistent pipeline execution is critical to the extending the virology.

Business and expanding further into oncology, we believe our current and pipeline therapies can address significant unmet medical needs.

We are very encouraged by the progress Gilead and kite are making we are well on our way in our journey to expand and diversify into new therapeutic areas and we are already.

Johanna Mercier: As we highlighted in prior quarters, we've been working with payers to ensure patients continue to have access to Dyscovi in light of the entry of generic alternatives for Truvada. We're really pleased to see the strong sequential growth in Dyscovee, and we continue to maintain mid 40% share despite generic impact. Year over year, Dyscovite grew 4%, largely due to higher demand for PrEP.

The evolution of both our pipeline and commercial portfolio.

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

Thanks, Dan and good afternoon, everyone.

Starting on slide 7 total product sales of $6.2 billion were up 21% year over year.

<unk>, primarily reflecting the clarity, which was not a contributor to revenue in the second quarter of 2020.

On slide 8 declared a second quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection hospitalization in many regions.

Johanna Mercier: And overall, PrEP demand is showing signs of recovery and is expected to continue to improve as pandemic restrictions phase out. Earlier this month, federal FAQs for the U.S. Preventative Services Task Force were released. It provides greater clarity as to the importance of PrEP in ending the epidemic, and we're really encouraged by this recent development. We hope it will help to minimize the barriers to PrEP use going forward. Before I transition to other products, I just wanted to take a moment to share some perspective on the HIV treatment market given the longer-than-expected pandemic impact. In regions outside of the U.S., such as Europe, we're beginning to see signs of recovery in the dynamic market, with second-quarter trends generally in line with our expectations.

While hospitalizations trended lower.

In the second quarter secondary remained debt there is the therapy of choice in 3 out of 5 patients hospitalized with COVID-19.

We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with <unk>, it's truly remarkable and encouraging to see how <unk> continues to play such a key role in fighting.

Fighting this global pandemic.

Excluding declarator total product sales at $5.3 billion were up 5% year over year.

We saw growth in cell therapy, and HCV. In addition to new revenue contributions from <unk> and more modestly <unk> ex for HDD.

Johanna Mercier: In the U.S., however, the pace of the pandemic recovery was slower than we expected in this last quarter. And while we're seeing signs of recovery in PrEP and some sequential growth in the treatment market, it's clear that it'll take several quarters for treatment to return to pre-pandemic levels. In treatment, there are really two pandemic-related headwinds that we observed: lower HIV screening and diagnosis, resulting in lower treatment initiation. And second, due to the limited support services available during the pandemic, we've seen a higher number of patients discontinue their HIV treatment.

Additionally, other product revenues of 290.

Again grew 20% year over year, driven by increased demand for Amazon outside of the U S to treat nuclear mycosis, which has seen a rising incidents in patients hospitalized with COVID-19.

Sequentially, we saw 9% growth for total product sales, excluding decorate primarily driven by growth in.

$1 million.

Moving to slide 9 HIV product sales were $3.9 billion up 8% sequentially and down 2% year over year.

Compared to the second quarter of 2020 total HIV revenue reflected strong big target growth that more than offset the $322 million lower revenue from Nevada.

<unk> following their loss of exclusivity.

Compared to last quarter, HIV grew $288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment.

Retardee revenue of $2 billion was up 24% year over year and 9% sequentially.

With quarter over quarter growth, primarily driven by increased demand.

The current <unk> remains the number 1 prescribed therapy in the U S across naive switch and continuing patients and remains number 1 in naive across all EU 5 countries.

Approximately 70% of switches from both Gilead and non Gilead.

Add regimen result in incremental revenue.

Overall and despite the ongoing impact of the pandemic victory continues to gain market share with 1% share growth versus last quarter in both the U S as well as the EU 5.

<unk> revenues of $435 million grew 21% sequentially.

<unk> due to a modest improvement in the demand for prep and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first.

Johanna Mercier: Given the strength of the demand fundamentals for Bictarvi, Dyscovi for PrEP, and other Gilead HIV products, we remain confident in our competitive positioning now that many communities are easing social distancing requirements. In the meantime, we continue to see strength in underlying treatment demand with no material changes in the competitive landscape, with our total Gilead treatment market share holding steady at 75% in the U.S. and just under 50% in Europe, despite competition and the entry of new generics. Next on slide 10, HCV product sales in the second quarter were $549 million, up 23% compared to last year. The patient starts rates remain well below pre-pandemic levels.

As we highlighted in prior quarters, we have been working with payers to ensure patients continue to have access to <unk> in light of entry of generic alternatives for Truvada.

We're really pleased.

To see the strong sequential growth in <unk>, and we continue to maintain mid 40% share despite generic impacts.

Year over year, <unk> grew 4% largely due to higher demand for prep and overall prep demand is showing signs of recovery and is expected to continue to improve as pandemic restrictions phase out.

Earlier this month federal ethic used for the U S. Preventative services Task Force were released.

Johanna Mercier: The growth reflects a modest sequential recovery in HCV patient starts in the U.S. in Q2-21, in addition to an artificially low Q2-20 that was impacted by unfavorable government rebate adjustments. We'll be watching for further signs of recovery in the third quarter. Both the U.S. and E.U.

Before I.

In addition to other products.

<unk> I just wanted to take a moment to share some perspective on the HIV treatment market given the longer than expected pandemic impact.

In regions outside of the U S such as Europe, we're beginning to see signs of recovery in the dynamic market with second quarter trends generally in line with our expectations.

Johanna Mercier: Gilead market shares remain steady at around 60% and 50% returns. Moving to slide 11. HPV and HDV product sales were $237 million, up 8% year-over-year, with improving patient starts on Vanlitty, particularly in ex-U.S. markets. In its first full quarter as part of Gilead, HEP CLUDEX contributed $7 million and is currently available in France, Germany, and Ireland. We're excited to be working with the various reimbursement authorities to increase patient access and expect to secure full reimbursement in the major European markets in 2022.

In the U S. However, the pace of the pandemic recover with Florida.

Slower than we expected in this last quarter and while we're seeing signs of recovery and perhaps in some sequential growth in the treatment market. It's clear that it will take several quarters per treatment to return to pre pandemic levels.

In treatment that really to pandemic related headwinds that we observed first lower.

Lower HIV screening.

And diagnosis, resulting in lower treatment initiation.

And second due to the limited support services available during the pandemic, we have seen a higher number of patients discontinue their HIV treatments.

Taken together. These 2 factors have reduced the number of active patients on HIV therapy entering 2021, thereby.

Johanna Mercier: Moving to Jidelvy on slide 12, product sales in the second quarter were $89 million, up 24% quarter over quarter, driven by demand for the two new indications approved in April, namely second-line plus metastatic triple negative breast cancer and urothelial. We continue to be encouraged by the positive feedback from physicians on the phase three ascent data, which demonstrated a one-year medium overall survival benefit for second-line metastatic TNVC patients To build on this growing interest, we're increasing community awareness, especially with the expanded indication to Second Line in TNBC. And we expect to see growing demand as breast cancer screening ramps back up to pre-pandemic levels. IQVIA data suggests that breast cancer screening volumes were about 20% lower in the U.S. in 2020 compared to 2019.

Thereby reducing the overall volume of new and refill prescriptions, we would expect to see in 2021, we.

We did however, see growth resumed from this lower base in the second quarter.

After prior quarter after quarter over quarter declines second quarter U S. HIV treatment prescriptions grew 2% and we expect the market to grow at historical rates 1.

Screening and diagnosis rates return to pre pandemic levels.

To continue our efforts to advance progress against the HIV epidemic, we're partnering with health care professionals advocacy groups and policymakers to raise awareness of the unique challenges COVID-19 poses to HIV screening diagnosis and adherence are.

Our goal is.

To help health care providers ensure that patients continue to be diagnosed and treated.

Given the strength of the demand fundamentals for Victor <unk> discovery for prep and other Gilead HIV products, we remain confident in our competitive positioning now that many communities are easing social distancing requirements.

Johanna Mercier: This suggests as many as 41,500 breast cancer patients have not been diagnosed during the pandemic. On behalf of Christy and the KITE team, I'm pleased to share a cell therapy commercial update on slide 13. Total cell therapy product sales totaled $219 million in the second quarter, representing 39% growth year-over-year, driven by both Yesarta and Takarta. Discarded growth was driven by strong demand in Europe as well as a successful follicular lymphoma launch in the U.S.

In the meantime, we continue.

To see strength in underlying treatment demand with no material changes in the competitive landscape with our total gilead treatment market share holding steady at 75% in the U S and just under 50% in Europe, Despite competition and the entry of new generics.

Next on slide 10 HCV product.

Sales in the second quarter were $549 million up 23% compared to last year. The patient starts remained well below pre pandemic levels.

The growth reflects a modest sequential recovery in HCV patient starts in the U S. In Q2 dollars 21. In addition to an artificially low Q2 of 'twenty that was impacted by unfavorable.

Johanna Mercier: Increased competition, particularly in third-line LBCL, continues to raise the profile of cell therapy and is positive for Kite overall. We remain confident in Yaskarta's competitive profile and positioning and are particularly proud of Kite's industry-leading manufacturing turnaround time and reliability.

Rebate adjustments.

We will be watching for further signs of recovery in the third quarter, both U S and EU Gilead market share has remained steady at around 60% and 50% respectively.

Moving to slide 11.

HBV in HDD product sales were $237 million up 8% year over year with.

Johanna Mercier: Our results also reflected strong momentum from the Ticardus Mantle Cell Lymphoma launch, highlighting the unmet medical need for MCLT. We continue to add new indications and geographies for our cell therapy programs. For example, the Fosun Kite Joint Venture recently received approval in China for Yaskarta as the first cell therapy to treat third-line LBCL, and we're excited to see the top-line data for ZUMA 7, getting us a step closer to second-line LBCL cell therapy.

Government proving patient starts on <unk>, particularly in ex U S market.

In its first full quarter as part of Gilead <unk> contributed $7 million and is currently available in France, Germany, and Austria, we're excited to be working with the various reimbursement authorities.

To increase patient access and expect to secure full reimbursement in the major European.

With <unk> in 2022.

Mark.

We continue to be encouraged.

Market feedback from physicians on the phase III ascent data, which demonstrated a 1 year medium overall survival benefit for second line metastatic <unk> patients treated with Qdoba.

Merdad V. Parsey: As Dan mentioned, it's been a gratifying year so far, delivering on all our key pipelines, supporting Gilead's ambitions to extend our leadership in HIV, and creating a broader portfolio spanning virology and oncology. Building our portfolio. I'll spend our time today on the highlights of the quarter and point you to the appendix of the earnings presentation for a more complete view of our pipeline. First, in HIV, as you can see on slide 15, programs for the investigational lenticap of your agent continue to progress. At the recent International AIDS Society meeting, we shared data from the Phase II-III Capella Study that evaluated heavily treatment-experienced individuals who've already developed resistance to multiple antiretroviral drugs. Capella demonstrated lenticapovir's potency in this difficult-to-treat population.

To build on this growing interest, we're increasing community awareness, especially of the expanded indication second line in <unk>.

And we.

By the policy growing demand as breast cancer screening ramps back up to pre pandemic levels.

<unk> data suggest that breast cancer screening volumes were about 20% lower in the U S in 2020 compared to 2019.

This suggest as many at 41500 breast cancer patients have not been diagnosed during the pandemic.

<unk>.

On behalf of Christie and the kite team I'm pleased to share our cell therapy commercial update on slide 13.

Total cell therapy product sales totaled $219 million in the second quarter, representing 39% growth year over year, driven by both your startup and to Curtis.

You start growth.

Growth was driven by strong demand in Europe, as well as successful Follicular lymphoma launch in the U S.

Increased competition, particularly in third line <unk> Bcl continues to raise the profile of cell therapy and is positive to kite overall.

Merdad V. Parsey: Despite significant prior, antiviral activity was observed starting at day By week 26, 81% of individuals had viral suppression when Lenacapivir was combined with an optimized background. Based on these data, we filed a new drug application. If approved, this would become the first six-month-long acting subcutaneous injection regimen available and deliver a welcome new option for people living with HIV who have developed multidrug resistance to other antiretrovirals. Also at IAS, we presented strong interim results from the Phase II Calibrate Study, evaluating Lenacapavir in treatment-naive patients.

We remain confident in your <unk> competitive profile and positioning and are particularly proud.

<unk> industry, leading manufacturing turnaround time and reliability.

Our results also reflected strong momentum from the to Cardiff mantle cell lymphoma launch highlighting the unmet medical need for mcl patients.

We continue to add new indications and geographies for our cell therapy products. For example, the posts on kite joint.

<unk> recently received approval in China for you started out the first cell therapy to treat third line <unk>.

And we're excited to see the topline data for Zuma, Kevin getting us a step closer to second line <unk> cell therapy.

Even as we prepare for discussions with regulatory agencies later this year commercial and manufacturing preparations are ramping up.

To ensure sufficient capacity and support for second line <unk> Bcl demand in both the U S and in Europe, Chris.

Merdad V. Parsey: These findings will be used to help inform our broader efforts establishing Lena Capovir as a foundational agent for our long-acting team. Late last month, we screened the first patient for the Phase 3 Purpose 2 trial, studying Lenacapivir for HIV prevention in cisgender men, transgender women, transgender men, and gender non-binary people who have sex with men and are at risk of HIV We expect to initiate a Phase 3, Purpose 1 study of linacapavir for HIV prevention in adolescent girls and young women later this year.

Christy is here with the teams to take your questions on cell therapy later in the call, but for now I'll hand, it over to Marta to walk us through the pipeline updates.

Thank you Johanna.

Dan mentioned, it's been a gratifying year, so far delivering on.

All of our key pipeline commitments supporting Gilead ambitions to extend our leadership in HIV.

Creating a broader portfolio spanning geology and oncology building our portfolio in inflammation.

I'll spend our time today on the highlights of the quarter and pointed to the appendix of the earnings presentation for a more complete view of our pipeline activities.

First in HIV as you can see on slide 15 programs for our investigational and a cap of your agents.

Merdad V. Parsey: Finally, we're actively working on a co-formulation for the long-acting investigational oral and injectable combination of lenacapavir and eslatavir and expect to initiate the oral phase two trial by the end of the year. Moving on to HDV, on slide 16, last month at the International Liver Congress, we presented data from the MIR 301 and MIR 204 programs. MIR 301 is a Phase III registrational study evaluating Gilever Tide as monotherapy for the treatment of HDV.

<unk> agents continued to progress.

At the recent International AIDS Society meeting, we shared data from the phase 2.3 capella study that evaluated heavily treatment experienced individuals who've already develop resistance to multiple anti retroviral viral.

Capello demonstrated <unk> potency in this difficult to treat population.

Quite significant prior resistance antiviral activity was observed starting the day 15.

By week 26, 81% of individuals' high viral suppression when Linea <unk> combined with an optimized background regimen.

Merdad V. Parsey: Interim results demonstrated that liver tide was well-tolerated in both cirrhotic and non-cirrhotic patients with compensated chronic HDV infection. At week 24, Levertide treatment was associated with significantly greater HDV RNA declines and improvements in biochemical measures of disease activity compared to no treatment. Moreover, there were no treatment-related serious adverse events leading to discontinuation.

Based on these data we filed the new drug application.

Prove this would become the first 6 month long acting subcutaneous injection regiment available and deliver a welcome new option for people living with HIV, who have developed multi drug resistance to other antiretrovirals.

Also with Ias, we presented strong interim results.

<unk> from the phase III calibrate study evaluating <unk> in the treatment naive population.

And calibrate.

Participants received lentic heavier either as a subcutaneous injection or is a daily oral pill in combination with the scoping.

Merdad V. Parsey: These results continue to support the effectiveness of the 2 mg dose, which has received conditional approval from the EMA and will form the basis of the BLA filing plan for later this year in the U.S. As part of our HDV cure efforts, we also presented interim data from the MIRA-204 Phase 2b study investigating finite regimens of dulabratide both as monotherapy and in combination with PEG interferon. Both monotherapy and combination treatments of The primary endpoint analysis will occur at 24 weeks after completion of therapy and will include biologic and biochemical response data.

At week 28, 94% of subjects achieved HIV.

1 RNA loads of less than 50 copies per mil.

These findings will be used to help inform our broader efforts, establishing <unk> as a foundational agent for a long acting franchise.

Late last month, we screened our first patient for the phase III purpose, 2 trials studying lending caps of year for HIV prevention and cisgender men Trans.

Our weighted transgender men agenda, nonbinary people, who have sex with men and our risk of HIV infection.

We expect to initiate the phase III purpose, 1 study of <unk> for HIV prevention, and adolescent girls and young women later this year.

Finally, we are actively working on the co formulation.

Merdad V. Parsey: We look forward to sharing those data when available. Moving to slide 17, and on behalf of Christine and the KITE, As you know, we shared earlier the strong, positive top-line data from Zuma 7. The Landmark 359 Patient Phase 3 Study Evaluating Yaskarta and Second Line LBCL. The study met the primary endpoint for event-free survival with a hazard ratio of 0.398, representing a 60% improvement in event-free survival compared to standard-of-care stem cell transplants. If SCARTA had a safety profile comparable to or better than what we have seen in the third line setting,

Transgenic for the long acting investigational oral and injectable combination of blended cap of hearing is flat for the year and expect to initiate the oral phase II trial by the end of the year.

Moving onto HBV on slide 16 last month at the International liver Congress, we presented data from the mere 301 in near 204 programs.

There are 301 is a phase III Registrational study evaluating <unk>.

Delever tied as monotherapy for the treatment of HBV.

Interim results demonstrated that <unk> was well tolerated, both cirrhotic and non cirrhotic patients with compensated chronic HBV infection.

24, <unk> treatment was associated.

Graham significantly greater HBV, RNA declines and improvements in biochemical measures of disease activity compared to no treatment.

Moreover, there were no treatment related serious adverse events leading to discontinuation.

These results continue to support the effectiveness of the 2 milligram dose, which has received conditional approval from the EMA.

And will form the basis of the BLA filing claim planned for later this year in the U S.

As part of our HCV cure efforts. We also presented interim data from the mirror to have 4 phase II <unk> study investigating finite regimens of Delever types, both as monotherapy and in combination with peg interferon Alpha.

Both monotherapy and combination treatments of <unk> were found to be generally well tolerated and more effective and peg interferon alone through 24 weeks of therapy.

The primary endpoint analysis occurs at 24 weeks after completion of therapy and includes biologic and biochemical response data.

Merdad V. Parsey: I look forward to beginning discussions with regulatory agencies later this year as we work towards potential SBLA and MAA filings for Yaskarta and second line LBCL. And, separately, we're on track for the Phase 2 readouts for our first-line LVCL study before the end of the year. Beyond LBCL, we've completed filing ESCARTA with the EMA for patients with follicular lymphoma after three or more lines of systemic therapy.

We look forward to sharing those data when available.

Moving to slide 17, and on behalf of Christine the kite team as you know we shared earlier the strong positive topline data from Zuma 7.

The landmark 359 patient phase III study evaluating <unk> in second line <unk>.

The study met the primary endpoint for event free survival.

<unk> with a hazard ratio of <unk> 398, representing a 60% improvement and event free survival compared to standard of care stem cell transplant.

Merdad V. Parsey: We also have a PDUFA date of October 1st under accelerated review with the FDA for Ticardis and ALL. And, of course, while our internal focus remains on autologous cell therapies, we continue our engagement in alternative approaches, most recently partnering with Shoreline Biosciences to develop novel off-the-shelf allogeneic cell therapies based on natural killer targets for hematologic. Slide 18 is a recap of our pipeline In addition to the items we've discussed already, our partner AHRQ provided an early interim update of their Phase 2 AHRQ 7 trial in late June, demonstrating clinical activity in the anti-TJIT-domlanilumab-based doublet and triplet combination. Zimbarellamab, our anti-TD1 antibody, saw similar levels of activity in the monotherapy arm compared to marketed anti-TD1.

<unk> had a safety profile comparable to or better than what we have seen in the third line setting.

This is a clinically and statistically meaningful improvement in outcomes that if approved in the U S could extend.

<unk> reached to a total unique population of 14000 patients annually in the second and third line <unk> setting.

Zuma 7 also met the key secondary endpoint of objective response rate as expected data for overall survival is immature at this time, but the interim analysis suggests the favorable trend.

Critical milestone.

In summary, we're very excited about the potential benefit to patients demonstrated in zuma 7 and look forward to beginning discussions with regulatory agencies. Later this year as we work towards potential <unk> and MAA filings for <unk> in second line <unk> and.

Merdad V. Parsey: Based on the interim analysis, we're pleased that Arc 7 and the confirmatory Phase 3 Arc 10 trial will continue to enroll as planned. We look forward to seeing how the data mature with additional patience and duration of follow-up to inform our opt-in decision. Separately, our partner, Galapagos, also shared data readouts from their Toledo SICK-2-3 programs across psoriasis, ulcerative colitis, and rheumatoid arthritis and plaque psoriasis data from their TIC-2 program. Both studies were early and had small samples, and we look forward to additional data.

And separately, we are on track for the phase III readout.

And as for our first line <unk> study before the end of the year.

Beyond <unk>, we have completed filing yes, Carter with the EMA for patients with Follicular lymphoma, after 3 or more lines of systemic therapy. We also have a <unk> date of October 1 under accelerated review with the FDA for to Carter's and Ao.

First while our internal focus remains on autologous cell therapies, we continue our engagement and alternative approaches.

Recently partnering with shoreline <unk> biosciences to develop novel off the shelf allogeneic cell therapies based on natural killer targets for hematologic cancers.

Merdad V. Parsey: We also remain focused on the following upcoming milestones. For TRDEL-V, we continue to target a Tropix-2 PFS readout this year. This study is an event-driven phase-three trial in patients with hormone receptor-positive tumors. Pending data, we will evaluate and determine the appropriate regulatory next steps. We estimate there are roughly 17,000 patients in the U.S. who could benefit from Tridelby in this setting.

Slide 18 is a recap of our pipeline.

And up in execution. So far this year. In addition to the items we've discussed already our partner ARCUS provided an early interim update of their phase III <unk> trial in late June demonstrating clinical activity in the anti <unk> dominant allomap based doublet and triplet combinations.

<unk>, our anti PD 1 antibody saw.

Similar levels of activity in the monotherapy arm compared to marketed anti PD 1.

Based on the interim analysis, we're pleased that our Kevin and the confirmatory phase III <unk> trial will continue to enroll as planned.

Merdad V. Parsey: We continue to expect a phase 3 non-small cell lung cancer trial for Tredelby to initiate in the second half of this year. We plan to share an update from the Tropics III basket study on lung cancer later this year, and we'll separately provide updates on head and neck squamous cell carcinoma and endometrial cancer as those data mature. We anticipate a Phase 1b readout from Angrolimab and MDS later this year, and pending data, we'll engage with regulators as we explore potential BLA filing for accelerated approval.

We look forward to seeing how the data mature with additional patients and duration of follow up to inform our opt in decision.

Separately, our partner Galapagos also share data readouts from our Toledo, <unk> 3 programs across psoriasis, ulcerative colitis, and rheumatoid arthritis, and the plaque psoriasis data from their TIK 2 program.

Both studies were early and had small samples and we look forward to additional data.

We also remain.

<unk> focus on the following upcoming.

Pending milestones for <unk>, we continue to target a <unk> to PFS readout this year.

Ladies and event driven phase III trial in patients with hormone receptor positive <unk> negative metastatic breast cancer pending data, we will evaluate and determine the appropriate regulatory next steps. We estimate there are roughly 17000.

Merdad V. Parsey: If approved, Migrolimab will be the first-in-class macrophage checkpoint inhibitor targeting CD47 and Gilead's first front-line oncology product in the country. There is a significant unmet need for MDS, with no new treatments approved in 14 years, despite 15,000 new patients being diagnosed each year in the US.

Patients in the U S, who could benefit from <unk> in this setting.

We continue to expect the phase III non small cell lung cancer.

<unk> to initiate in the second half of this year, we plan to share an update from the tropics III basket study on lung cancer. Later this year, we will separately provide updates on head and neck squamous cell.

Merdad V. Parsey: We continue our development efforts in AML and have enrolled our first patient in the Phase III Frontline AML Macromed Study. Before I wrap up the pipeline discussion, I wanted to share an update on Remdesivir. We've decided not to move forward with an inhaled formulation of remdesivir based on the results of our initial proof-of-concept study, suggesting suboptimal lung depth. To address patient needs in the evolving pandemic, we are continuing our efforts to advance multiple novel antivirals.

And endometrial cancer as those data mature.

We anticipate a phase <unk> readout for <unk> in Mds later, this year and pending data will engage with regulators as we explore a potential BLA filing for accelerated approval.

If approved <unk> will be the first in class macrophage checkpoint inhibitor.

Sell cars targeting CD 47, and Gilead first frontline oncology indications.

Merdad V. Parsey: We expect to submit IND filings later this year or early next year for these agents, and we remain committed to supporting patients through this pandemic and continuing our legacy of developing antiviral therapeutics for the treatment of emerging. Finally, on slide 19, I want to recognize the teams at Gilead. Compared to just two years ago, our pipeline has grown from 30 clinical-stage programs to over 50 today and resulted in a considerably more diverse set of assets that can be transformative not only for patients but for Gilead.

There's a significant unmet need for Mds with no new treatments approved in 14 years, Despite 15000, new patients being diagnosed each year in the U S alone.

We continue our development efforts in AML and <unk>.

Enrolled our first patient in the phase III frontline.

AML the <unk> study.

Before I wrap up the pipeline discussion I wanted to share an update on the index severe.

We've decided not to move forward with an inhaled formulation of <unk> based on the results of our initial proof of concept study, suggesting suboptimal lung deposition.

To address patient needs and the evolving pandemic.

We are continuing our efforts on advancing multiple novel anti Antivirals.

Merdad V. Parsey: The Gilead and Tite teams have worked tirelessly to deliver on our pipeline programs during this time of dramatic growth despite the pandemic. It's a thrilling time to be part of the team with such tireless dedication and commitment to helping.

We expect to submit IND filings later this year or early next year for these agents.

Remain committed to supporting patients through this pandemic and continuing our legacy of developing antiviral therapeutics for the treatment of emerging diseases.

Finally on slide.

Mid 19, I want to recognize the teams at Gilead and kite compared to just 2 years ago. Our pipeline has grown from 30 clinical stage programs to over 50 today and resulted in a considerably more diverse set of assets that can be transformative not only for patients for gilead.

The Gilead and kite teams have worked tirelessly to deliver on our pipeline programs during this.

Time of dramatic growth despite the pandemic.

It's a thrilling time, they would be part of the team with tireless dedication and commitment to helping patients.

Forward to updating you on our progress in the quarters ahead.

With that I'll hand, the call over to Andy to walk us through the financial results of the quarter.

Thank you Mark to add and good afternoon, everyone.

Moving to slide 21.

<unk> financial results in the second quarter was solid overall with total product sales up 21% year over year, given the important role of debt Glory continues to play in this pandemic.

Excluding <unk> total product sales grew 5% year over year with strong <unk> growth more.

I'm setting lower truvada in a triple a revenues in addition to impressive growth in cell therapy and of course, the new revenue contribution associated with <unk>, which was not part of our portfolio in the second quarter of last year.

Andrew D. Dickinson: Moving down the P&L, non-GAAP product gross margin was 86.4% in the second quarter, 210 basis points higher year over year, and primarily associated with a lower royalty expense. Non-GAAP R&D was $1.1 billion, down 9% year-over-year, with lower remdesivir-related investments as compared to the same period last year, partly offset by higher investments across our pipeline, notably Tredelby Non-GAAP SG&A expense was $1.1 billion, down 4% year over year, primarily due to lower legal expenses offset in part by continued commercial investment in Tredelvia Becklery outside the United States.

Moving down the P&L non-GAAP product gross margin was 86, 4% in the second.

Quarter, 210 basis points higher year over year, and primarily associated with a lower royalty expense.

Non-GAAP R&D was $1.1 billion down 9% year over year with lower Ram desk Covid related investments as compared to the same period last year, partly offset by higher investments.

Across our pipeline, notably <unk> and Mccullough Mab.

Non-GAAP SG&A expense was $1.1 billion down 4% year over year, primarily due to lower legal expenses offset in part by continued commercial investment in <unk> outside the United States.

Andrew D. Dickinson: Moving to tax, we realized a lower effective tax rate of 19.6% for the quarter, or down 320 basis points year over year, due to a shift in geographic earnings mix. Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021, compared to $1.11 for the same period last year. The year-over-year improvement primarily reflects higher product sales due to VECLRI, higher gross margin, as well as lower operating expenses and a lower effective tax rate, offset by lower interest income.

Moving to tax we realized a lower effective tax rate of 19, 6% for the quarter were down 320 basis points year over year due to a shift in geographic earnings mix.

Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021.

Compared to $1.11 for the same period last year.

The year over year improvement, primarily reflects higher product sales due to VAT glory higher gross margin as well as lower operating expenses and a lower effective tax rate offset by lower interest income.

Overall, we're encouraged by our first half results shown on slide.

Susan.

Yeah.

With that said, we now expect full year total product sales in the range of $24.4 billion to $25 billion compared to our previous range of $23.7 million to $25.1 billion.

Andrew D. Dickinson: The new range increases the midpoint from $24.4 billion to $24.7 billion and reflects our solid results year-to-date as well as our updated expectations for the second half of the year. With first-half Vecluri revenue of $2.3 billion, we now expect full-year Vecluri revenue in the range of $2.7 to $3.1 billion compared to our previous $2 to $3 billion range. Our updated range reflects the ongoing role of Becklery in this pandemic and assumes we'll continue to see regional outbreaks.

The new range increases the mid point from $24.4 billion to $24.7 billion and reflects our.

Our solid results year to date as well as our updated expectations for the second half of the year.

With first half like Lori revenue of $2.3 billion. We now expect full year Vickery revenue in the range of $2.7 million to $3.1 billion compared to our previous $2 billion to $3 billion range.

Our updated range reflects the ongoing.

Secretary of this pandemic and assumes we'll continue to see regional outbreaks.

Andrew D. Dickinson: The situation continues to be dynamic, and we'll likely update our thinking again when we report our earnings after the third quarter. Back to our guidance, we now expect total product sales excluding Veclurie for the year to be in the range of $21.7 billion to $21.9 billion compared to our previous range of $21.7 to $22.1 billion. This tightening of the range reflects the longer-than-expected pandemic impact on our business, including the latest increase in COVID-19 cases.

The situation continues to be dynamic and we'll likely update our thinking again, when we report our earnings after the third quarter.

Back to our guidance, we now expect total product sales, excluding VAT glory for the year to be in the range of $21.7 billion.

S dollars to $21.9 billion compared to our previous range of 21, 7% to $22.1 billion.

This tightening of the range reflects the longer than expected pandemic impact on our business, including our latest increase in COVID-19 cases.

Andrew D. Dickinson: As Johanna discussed, the pandemic has most notably impacted our HIV treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuations than expected in 2020. It's taking longer than we expected for treated patient volume to ramp back up to more normal levels, particularly in the United States.

As John has discussed the pandemic as most notably impacted our HIV treatment.

Treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuation is unexpected in 2020.

It's taking longer than we expected for treated patient volume to ramp back up to more normal levels, particularly in the United States.

That said, we saw encouraging signs of recovery in the HIV market in the second quarter and.

It assumes recovery will continue through the remainder of the year.

Based on market share dynamics, we remain very confident in our competitive positioning and we believe we are well positioned as the recovery continues.

Looking at the rest of our P&L, we now expect non-GAAP product gross margin in the range of 86% to 87% reflecting.

In our <unk> mix of HIV revenue.

Andrew D. Dickinson: We now expect non-GAAP R&D to decline by a low to mid-single-digit percentage compared to 2020 levels. This primarily reflects the timing of investments, and we remind you that the expenses for both R&D and SG&A are back-end loaded this year, increasing sequentially from Q2 into Q3, and then even more from Q3 into Q4. Our non-GAAP SG&A guidance remains unchanged, a flat to low single-digit percentage decline over 2020. In R&D, we'll be ramping up additional studies with migrolimab, Tredelvi, long-acting combination work with lenacapavir for the treatment of HIV, and other pipeline activities.

We now expect non-GAAP R&D to decline low to mid single digit percentage compared to 2020 levels.

Primarily reflects the timing of investments and we remind you that the expenses in both R&D and SG&A are back end loaded this year increasing sequentially from Q.

The loan to Q3, and then even more from Q3 into Q4 or.

Our non-GAAP SG&A guidance remains unchanged.

<unk> to low single digit percentage decline over 2020.

And R&D will be ramping up additional studies with Nikola Mab <unk> long acting combination work with <unk> a cap of year for the treatment.

Rent of HIV and other pipeline activities and in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications such as with <unk>.

Andrew D. Dickinson: And in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications, such as with Tridelby and Decartas. Finally, reflecting the updates to our revenue, gross margin, and operating expense guidance, we now project non-GAAP diluted EPS between $6.90 per share and $7.25 per share for the year, and GAAP diluted EPS between $4.70 and $5.05. Additionally, our capital allocation priorities have not changed, and we remain committed to our dividends.

Finally, reflecting the updates to our revenue gross margin and operating expense guidance, we now project non-GAAP diluted EPS between $6.

<unk> and <unk> 90.

<unk> per share and $7.25 per share for the year and GAAP diluted EPS between $4.70 and $5.5.

Additionally, our capital allocation priorities have not changed and we remain committed to our dividend.

Year to date, we've paid down 1 billion 1.

$5 billion in debt and we're on track to repay at least 4 billion in debt by the end of the year.

With that 1 night, the operator to begin the question and answer session.

Thank you as a reminder to ask a question you will need to press star 1 on your telephone to withdraw your question press the pound key in the interest.

We ask that you please limit yourself to 1 question. Please standby, while we compile the Q&A Ross day.

Our first question comes from current cash them off with J P. Morgan Your line is open.

Corey Kasimov: Hi, this is Gavin on behalf of Corey. Thanks for taking our question. Just wanted to go back to the U.S. HIV business. Can you provide additional color, particularly in the context of why this is so much different from the U.S. markets? And what is the most important factor you'll be watching for to have confidence in the U.S. market normalizing? Thank you. Yeah, thanks a lot, Gavin, for joining me. I'm obviously going to turn it over to Johanna.

Hi, This is Kevin on for Cory. Thanks for taking my question just wanted to go back to the U S HIV business.

This time Mark can you provide additional color, particularly in the context of why this is so much different from the ex U S markets and what is the most important factor you'll be watching for to have confidence in the U S market normalizing. Thank you.

Yes, Thanks, a lot again for joining I'm, obviously going to turn that over to Joanna.

I would just point out that we continue to do.

Really well and our share and certainly a big target growth.

We are well.

Well positioned as the market rebounds, and with that I'll turn it over to Joana for some specifics.

Hi, Kevin.

Thanks for your question I think from a market dynamic standpoint.

What we're seeing is we saw a little bit last year in Q2, most of the industry was actually slowing down pretty quickly in Q2, HIV took a little bit longer and it's kind of playing out in 'twenty..1 is taking a little bit longer to come back and bounce back 1 of the major reasons for that has to do with your dynamic market being much smaller.

Johanna Mercier: Thanks for your question. I think from a market dynamics standpoint, what we're seeing is that we saw a little bit last year in Q2, and most of the industry was actually slowing down pretty quickly in Q2. HIV took a little bit longer, and it's kind of that's playing out in 21 as taking a little bit longer to come back and bounce back. From a different standpoint between the U.S. and Europe, I think it has more to do with the fact that in Europe, there's diversity across some of the different countries as to the pandemics and the timing of kind of the recoveries or even some of the surges that happen. So it's a little bit more mixed than what we've seen in the U.S. thus far.

The market you have a very large pool of patients that are just continuing patients and you're really playing in the dynamic market with your naive.

Patients coming in.

And your switches and you restart really around 5% or so and so that's why it's taking a little bit longer.

As we're going through that from a different standpoint between.

And this asset in Europe, I think it has more to do with the fact that in Europe. There is diversity across.

Some of the different countries as to the Pandemics and the timing of.

And kind of the recoveries or even some of the searches that happens so it's a little bit more blended than what we've seen in the U S. Thus far and so I think that's just what's playing out here obviously.

You are impacting in the U S. Because that's where most of our business lines in HIV.

And just to close out on that.

Johanna Mercier: And so I think that's just what's playing out here. Obviously, the bigger impact is in the U.S. because that's where most of our business lies in HIV. So we're very pleased with the continued growth of VicTarvi. And you can appreciate that because it's such a larger base, it's going to get more challenging as we move forward. And that's why I think we're excited about the market coming back a little bit. We saw it come back in Q2. Where the market goes, obviously, our HIV business will go with it because we own 75% of the market. That's great, Joanna.

From a market standpoint, and it's very different than kind of the fundamentals of our HIV business I think what we've seen with the <unk>.

Really quite quite pleased with in light of the fact that not only it has grown quarter over.

The Big 1 point, both in the U S as well as in the EU 5 but also if you think about it over the last 12 months has grown 6 point share over a very strong base. We're just under 40% we're at 39% share.

At this point in time, so we're very pleased with the continued growth of victory and you can appreciate that because its such a larger base that is.

Quarter more challenging as we move forward and and Thats why.

I think we're excited about the market coming back a little bit we've seen it come back in Q2 were.

Where the market goes obviously, our HIV business goes because we own 75% of the market and and so therefore, we're watching that very closely but we would expect that recovery to continue.

Johanna Mercier: Anything on the indicators? I think you mentioned it. Is there anything more on the indicators that you'll be looking at? Yeah.

Although at a slower pace than we had originally expected.

Johanna Mercier: So we've been looking, of course, at HIV screening and diagnosis and how that's playing out. And we're still under by about 13% to below pre-COVID levels. So I think once those come back up, I think that will be something that we're watching very closely. And also the drop-off rates. We talked a little bit earlier about the adherence piece of the puzzle because you have fewer patient support groups around. You have less surround sound around those HIV patients.

Great John anything on the indicators.

You've mentioned designing more on the indicators should we look at yes. So we've been looking of course at the HIV screening and diagnosis.

In.

And how that's playing out and we're still under by about 13% to below.

Get COVID-19 levels. So I think once those come back up I think that would be that would be something that we're watching very closely and also the drop off rates, we talked a little bit earlier about debt the.

The <unk> piece of the puzzle because you have.

You have less patient support groups around do you have that surround sound around.

Johanna Mercier: You have a lot of those case managers and physicians that have moved over to treat COVID-19, and so it's impacting HIV a little bit disproportionately. And so we're also looking at those drop-offs, and we've seen those drop-offs come back to normal to pre-COVID levels just recently. And so that's another positive sign of that recovery of the mark. And Gavin, obviously, just from a patient perspective, we have been and will continue to be dedicated to helping patients, particularly in underserved communities, get back into the care system.

Those HIV patients you have a lot of those case managers and physicians that have moved over to treat COVID-19, and so far impacting HIV a little bit disproportionately and so we're also looking at those drop off and we've seen those drop has come back to normal to pre COVID-19 levels. Just most recently and so that's another positive sign to the recovery of the market.

And Kevin obviously, just from a patient perspective.

And we're continuing to be dedicated to helping.

Helping patients, particularly in underserved communities get back into the care system, I think thats something that Gilead prides itself on.

Johanna Mercier: I think that's something that Gilead prides itself on, and it's exceptionally important as a leader in HIV medicine to make sure we are always on the side of patients as we emerge from this pandemic. So, thanks for the question, Gavin.

Exceptionally important as a leader in HIV medicines to make sure. We are always on the side of the patients as we as we emerge.

<unk> from this pandemic so thanks for the question Kevin.

Daniel O'Day: Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Your line is open.

Terence Flynn: Great. Thanks so much for taking the question. Maybe two-part for me.

Great. Thanks, so much for taking the question maybe 2 part for me first for Joanne I'm. Just wondering if you can provide any more insight on the <unk> launch specifically.

Typically the split of sales by either setting or indication and then for Mark can you remind us of the size of the lung cancer cohort in tropics <unk> III and then how are you thinking about the potential risk of ILD in that population. Thank you.

Yes go ahead, John Scheurer. Thanks for the question. So yes, so we're really pleased with the <unk> sales.

Johanna Mercier: Sure. Thanks for the question. So, yeah, we're really pleased with the TLV sales. A 24% growth quarter over quarter, I think, is a very strong quarter. And I think that really has to do with the approval, the second line plus approval that we got in metastatic triple negative breast cancer early April. It's also related to the fact that, because now we have full approval, we have the opportunity to promote the incredible overall survival data that we have with the ASCEND data.

Sales at 24% growth quarter over quarter, I think is a very strong quarter and I think that really has to do with the approval. The second line plus approval that we got in metastatic triple negative breast cancer. Early April. It is also related to the fact that because now we have the full approval we have the opportunity to promote the incredible overall.

Total data that we have with the ascent data and so that's been a big piece of the puzzle.

If youre asking me to split the sales per line of therapy, that's very challenging in light of the claims data that we had the debt that we have.

But what I would say if it's more about.

Bladder cancer versus triple negative breast cancer, I would say most of that.

<unk> negative breast cancer, probably about a 90.10 ratio as a bladder cancer is much smaller although we've done some nice inroads there already and are looking at about.

Johanna Mercier: Although we've made some nice inroads there already and are looking at about just under 10% share in the bladder right now with TRDELV, so we're excited about that as well. And then with Tropics 3, it's a basket study, so the ends per arm are not, you know, hard and fast.

Just under 10% share in bladder right now.

With <unk>, so we're excited about that as well.

Got it and then with <unk> III.

Basket studies so.

The <unk> per.

Arm or not.

Merdad V. Parsey: We'll probably be looking at data once we get to the, you know, the 20-30 range in there, but it's not predetermined. So, you know, I wouldn't want to overstate it. Regarding ILD, we are definitely very sensitive to and watching for it, as you can imagine. To date, we haven't had any reports of that, but we're ever vigilant.

<unk> fast.

Probably be looking at data once we get to the 2.

<unk> thousand 30 range in there, but it's not predetermined so I wouldn't want to.

Overstated.

Regarding ILD.

We are definitely <unk>.

Sensitive to and watching for it as you can imagine.

To date, we haven't had any reports of that but.

We are ever vigilant so.

Operator: Great. Thank you both. Thanks, Terence. We'll get the next question now.

Great. Thank you both.

Thanks, Terrence will go to the next question now please.

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

Thank you our next question.

Western comes from Brian Abrahams with RBC capital markets. Your line is open.

Operator: Hey, good afternoon. Thanks for taking my question. A question regarding the HIV life cycle. You recently reported data for a sub-2 lenacapavir-based combo in the treatment of HIV. I'm curious, how do the learnings there with respect to the resistance profile you're observing shape how you think about the future development steps vis-a-vis potentially exploring higher doses, more frequent than every six months injections, and or combining with agents that might have higher intrinsic barrier resistance versus FTAP?

Hey, good afternoon. Thanks for taking my question a question regarding HIV lifecycle, usually before data for sub Q line of catheter based combo of treatment naive HIV.

I'm curious how does the learnings there with respect to the resistance.

Profile Youre observing shape, how you think about the future development steps vis vis potentially exploring higher doses more frequently more frequently than every 6 months injections, Andrew or combining with agents that might have higher intrinsic barrier to resistance versus <unk> and then I guess along the lines of HIV lifecycle I'm also curious your level of confidence.

Operator: And then, along the lines of the HIV life cycle, I'm also curious about your level of confidence as to the potential of FTAP to have exclusivity beyond 2025. Great. Why don't we have you start, Merdad, and perhaps Andy can comment a little bit on the second piece, too? Yeah, thanks. It's a very good question.

So the potential of.

<unk> have exclusivity beyond 2025.

Yeah.

Great.

We have you start John and perhaps Andrew can comment a little bit on the on the second piece too yes. Thanks.

Very good question I think if you think about the patients in that trial. These are highly treatment experienced patients who.

Merdad V. Parsey: I think if you think about the patients in that trial, these are highly treatment-experienced patients who often develop resistance because of noncompliance. And when these subjects are getting a sub-Q injection of linocapavir, remember that these patients are going to potentially continue to go off and on their oral regimen. As we think about the future, as you know, we are, for treatment, going outside the highly treatment-experienced population, and we're really thinking about how we're going to combine Lenacapazir with other long-acting agents like Isflatrix. And as we do so, I think the concerns about patients... Potentially having effective monotherapy with lenacapavir go away in some respects, right?

Awesome.

Develop resistance because of noncompliance and win.

These subjects are getting a sub Q injection of <unk>.

Remember that these patients are going to potentially continue to go off and on their oral regimens as we think about the future.

As you know we are for treatment.

Outside of the highly treatment experienced population, we're really thinking about how we're going to combine <unk> with other long acting agents like it's flatter here.

And as we do so I think the concerns about patients potentially.

Having.

Effective monotherapy with <unk>.

Merdad V. Parsey: Ensuring that patients are taking multiple agents at the same time is going to be really important for us. Thanks, Merdad. And perhaps, Andy, you want to comment on the exclusivity question for Brian? Sure. I'd be happy to. Hi, Brian.

Go away in some regards right ensuring that patients are taking multiple agents at the same time is going to be really important for us.

Thanks for that and perhaps Andrew you want to comment on the exclusivity question for Brian.

Sure I'd be happy to hi, Brian Thanks for the question.

Andrew D. Dickinson: Thanks for the question. As you know, there is litigation that's ongoing. There were some recent developments that a number of analysts wrote about. Our base case continues to be that there will be generics arriving in 2025 and 2026 in the U.S. and EU, respectively. But we think we have a strong case and that we look forward to continuing to prosecute the case, and we'll see where it plays out. We should have an additional update later this year. So that's really where it stands. Thanks, Annie. Can we have the next question, please?

As you know.

There is litigation Thats underway there were some recent developments.

Number of analysts wrote about.

Our base case continues to be that there'll debt.

There'll be generics, arriving in 2025 and 2026 in the U S.

And EU, respectively, but we think we have a strong case and.

We look forward to continuing to.

Moving to prosecute the case and we'll see where it plays out we should have an additional update later this year. So that's really where it stands.

Thanks, Andy can we have the next question please.

Operator: Thank you. As a reminder, in the interest of time, we ask that you please limit yourself to one question. Our next question comes from Jeffrey Porges with SBB Link. Your line is open.

Thank you as a reminder, in interest of time, we ask that you. Please limit yourself to 1 question. Our next question comes from Geoffrey Porges with SVP Leerink. Your line is open.

Jeffrey Porges: Thank you very much for taking the question. So, there are just a couple of parts to my question. Could you clarify a couple of your partnerships? There's been some news from Galapagos. You've invested over $5 billion there.

Thank you very much for taking the question. So just a couple of Pops in my question could you clarify a couple of your partnerships.

Operator: Are you going to take on any of those drugs from the Toledo portfolio that the company recently highlighted? And then, related to that, your Arcus partnership, does your guidance include the upfront cost of opting in for any of those programs? And what's the trigger and the window for when you can opt in to any of those three programs? Because they sort of appear on your pipeline slide, but it's not completely clear whether they're in or out.

Does your guidance include the upfront cost of opting in for any of those.

As programs and what's the trigger.

Window for when you can opt in 20 of those 3 programs because they sort of appear on your pipeline slide, but it's not completely clear whether theyre NOL. So could you clarify where you're going with those 2 partnerships.

Jeffrey Porges: So, could you clarify where you're going with those two partnerships? Sure, Geoff, thank you very much for the question. I'll start with a little bit and then ask Merdad and Andy if they want to add anything as well.

Sure Jeff. Thank you very much for the question and I'll start.

Start a little bit and then ask Andrew if you want to add anything as well. So I think first and foremost I think we are.

Daniel O'Day: So, first and foremost, I think we're, you know, we believe deeply in partnerships. We have a robust internal portfolio, and we also, as you know, have designed these opt-ins as a way to expand our portfolio in different therapeutic areas, starting with Galapagos, which is predominantly focused on inflammation. You know, at this stage, we don't have any opt-in milestones right now with Galapagos. We're working closely with them on their science and their discovery platform and some of their preclinical to clinical molecules to support them in their efforts.

We believe deeply in partnerships.

We have a robust internal portfolio and we also as you know a design these opt ins as a way to expand our portfolio in different therapeutic.

Computing area, starting with Galapagos as you know, which is predominantly focused on inflammation.

At this stage.

We don't have any opt in.

Milestones right now with Galapagos, we're working closely with them on their science and their discovery platform and some of the preclinical to clinical molecules.

To support them in their efforts, but at this stage.

Merdad V. Parsey: But at this stage, we don't have anything more to report other than what Galapagos has reported on the, for instance, Geoff, to your question on the Toledo program. But rest assured that as those programs evolve and mature and develop, we'll keep you informed. Perhaps, Mirdad, if you want to say anything else about the Galapagos and the bridge to Arcus? Yeah, I think the stories are similar. We like to keep you apprised of what could potentially come into our portfolio, and we have the opt-in rights to do so. For Arcus, I mean, I think Dan laid out Galapagos well.

We will keep you informed perhaps more debt if you want to say anything else and Galapagos.

Arc is yes, I think I think the stories are similar that we like to keep.

You apprised of what could potentially come into our portfolio and we have opt in rights to.

For arc is I mean, I think day.

Dan laid out Galapagos well for ARCUS, we continue to wait for data to mature.

Merdad V. Parsey: For Arcus, we continue to wait for data to mature. And once the data get to a level of maturity where we can really make the call, that's when we'll have our opt-in. We have not included, and Andy will confirm for me, but we have not included the financials of a potential opt-in in our guidance. That's correct. Yeah, I'm happy to follow up here, Geoff. Good question.

Bridged.

And once a day to get to a level of maturity, where we can really make the call.

That's when we will have our.

Our opt in we have not included in <unk>.

Andrew will confirm for me, but we have not included the financials.

Potential opt in in our guidance at this point.

Andrew.

Sure <unk>.

Yes, I'm happy to follow up here, Jeff Good question.

Andrew D. Dickinson: Nothing has changed from the guidance at the beginning of the year, so our R&D spend and all of our expense guidance do not include the opt-ins on any of the programs that we have options for, including the three programs that you mentioned at Arcus. You also asked about the opt-in windows. The opt-in window for the first-digit antibody should be coming most likely at the end of this year. It could be early next year, but it's most likely at the end of this year that we'll have enough patient data to trigger the opt-in or our desire to opt-in potentially early.

Andrew was the.

The opt in window for the first pitch at antibody.

Should be coming most likely at the end of this year. It could be early next year, but it's most likely at the end of this year, we'll have enough patient data.

The opt in or our desire to opt and potentially early.

Andrew D. Dickinson: On the other two programs, the Adenosine programs at Arcus, that's most likely next year. And again, there may be additional data that comes this year, but if it looks really strong, we want to move as quickly as we can, and we can opt-in early, Geoff, on those programs. And then on Toledo, it's relatively simple.

On the other 2 programs the identity and Kroger.

So it's most likely next year and again there may be additional data that comes this year.

If it looks really strong.

Want to move as quickly as we can and we can often early Jeff on those programs and then on Toledo, It's relatively simple and all of that Galapagos programs. The opt in comes after phase 2 enabling studies. So that suite of programs are a long ways away from.

Operator: On all of the Galapagos programs, the opt-in comes after Phase II enabling studies, so the Toledo programs are a long ways away from a potential opt-in decision. OK, page 3. Yeah, I'm sorry, Phase 3 enabling, thank you. Geoff, and I just kind of round out your question. I mean, obviously, there are many other partnerships we have that we're working closely with at different phases, but those are the specific ones you asked about. Thank you very much for the question. Can we have the next question?

Brands that are potential opt in decision.

Phase III, enabling.

Okay I'm sorry.

Phase III, enabling thank you.

Alright.

Sure Fair enough.

Round out your question I mean, there's obviously many other partnerships we have that we're working closely with different phases, but those are the specific ones you're asking about.

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

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

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

Operator: Great afternoon, guys. Thanks for taking the question. A question for Dan, Ora, or Merdad on COVID. You know, there's a high expectation that vaccines are here for a while now, and the Delta variant has really changed the dynamic. The question is, has the strategic value of Veclary changed for you guys as new cases have picked up? I know you decided not to pursue Inhale, but is there a life cycle here worth investing in over the long term?

Great afternoon, guys. Thanks for taking my question.

A question for Dan or a merchant Martin add on Covid, There's a high expectation that vaccines are here for a.

Thank you Robin now that the Delta variant is does it.

It really changed the dynamic. The question is has the strategic value of victory changed for you guys. As new cases have ticked up I know you decided not to pursue inhaled, but as their lifecycle here worth investing in over the long term. Thank you.

Daniel O'Day: Thank you. Thanks, Geoff. I'll start, and then Merdad will either correct me or add more information to it. But I think, I mean, just to emphasize the importance of Gilead's legacy in antivirals and, frankly, our strength in that, too, to us as well. So, you know, being, of course, the first company to have, and the only company to have an approved antiviral for COVID is no accident. Obviously, it's decades of experience, and decades of investments in a variety of emerging viruses, including COVID. And we haven't stopped.

Thanks, Jeff I'll start and then.

Wildly there correct me or add Mark information to do it but I think.

Just to just to emphasize.

<unk>.

Okay.

The importance of Gilead legacy and anti Virals, and frankly, our strength and that to us as well so.

Being of course, the first company to have.

Index and the only company to have an approved anti viral for.

For Covid. It is no accident, obviously has decades of experience decades of investments in a variety of emerging viruses, including Covid and we haven't stopped so.

Merdad V. Parsey: So, you know, to your point, Geoff, I think we're all learning about this pandemic as it rolls out. And it's certainly, you know, going through different phases, and we think we'll continue to go through different phases. And therefore, we are, if you like, kind of doubling down on an ability to think about antivirals outside the hospital setting, where remdesivir plays such an important role. And maybe with that, I'll hand it over to Merdad, as a clinician, how you might also see the future of the pandemic and then also our role in it. Yeah, thanks.

To your point, Jeff I think we're all learning about this pandemic as it rolls out.

Certainly.

Going through different phases, and where we think we will continue to grow through different phases.

And therefore, we are if.

If you like kind of doubling down on an ability to think about anti virals outside the hospital setting were around just severe plays such an important role and maybe with that I'll hand, it over a number of debt.

As a clinician.

And how you might also see some.

So to answer the debt net of given also our role in it yes. Thanks.

Merdad V. Parsey: I think we have consistently been of the mindset that the vaccines will make a tremendous impact on the case numbers and those sorts of things. Even though, I think, even when we get to some sort of equilibrium, unfortunately, there will continue to be, we believe, infections. People will continue to get infected, and some proportion of those patients will end up in So, we do believe that the glory in the hospitalized setting is going to continue to be really important for treating those patients, and as Dan alluded to, we continue to believe in and are committed to treatments, making treatments available in the outpatient setting.

We have I think pretty been pretty consistently of the mindset that.

<unk>.

The vaccines will will make.

Tremendous impact.

The case numbers in.

And other things.

So.

We do believe that debt Cleary in the hospital.

Total life setting is.

He is going to be continue to be really important for treating those patients and as Dan alluded to we continue to believe and are committed to.

Treatments, making treatments available in the outpatient setting.

So I wouldn't.

Merdad V. Parsey: So I wouldn't, you know, the inhaled, nebulized approach didn't give us the results we were hoping for, the consistency we were looking for, but because we have other agents in our pipeline based on our virology expertise, we will be bringing those forward and really focusing on the outpatient setting there. So we continue to believe that having a treatment available for people, whether they're vaccinated or not, is going to be important for the foreseeable future. And, Geoff, what I might add is that, you know, our preclinical folks continue to study remdesivir against a variety of variants.

The <unk>.

Inhaled <unk>.

<unk> approach.

Didn't give us the results we were hoping for the consistency we were looking for but because we have other agents in our pipeline based on our neurology expertise, we will be bringing those forward.

And really focusing on the outpatient setting there so.

We continue to believe that.

Having a treatment available for people.

Whether they are vaccinated or not is going to be important for the foreseeable future.

And Jeff what I might add is that our <unk>.

Preclinical folks continue to study room debt severe against the variety of variance in fact, all 4 major variance of concern.

Merdad V. Parsey: In fact, all four major variants of concern, so the alpha from the U.K., the beta from South Africa, the gamma from Brazil, and the delta from India, and all are fully sensitive, you know, against, or remdesivir is as sensitive against all those strains, which would make sense because we're not seeing any mutations in the polymerase remdesivir binding site. And so I think it's important, as we think about, you know, next-generation products, to also think about medicines that will be effective against these ongoing variants like remdesivir. It's an important bar for us as we move forward. Thanks, Geoff, for the question.

<unk> so the alpha from UK to the beta from South Africa, the gamma from Brazil, and the Delta from India.

And all are fully sensitive.

Against.

Sure.

Industrial is a sensitive against all those strange 1.

It makes sense, because we're not seeing any mutations in the preliminary.

<unk> run that severe binding site.

And so I think it's important as we think about next generation products to also think about medicines that.

Will be effective against these ongoing variance microgram debt severe items, it's an important bar for us as we move forward.

Thanks, John for the question.

Daniel O'Day: Thank you. Our next question comes from Umer Raffat with Evercore. Your line is open. Hi guys, thank you for my question.

Thank you and our next question comes from Omar Saad with Evercore. Your line is open.

Hi, guys. Thanks for taking my question I had 2 quick ones as well first have you had an interim PFS on the HR positive study of <unk>.

Umer Raffat: I had two quick ones as well.

And secondly.

Rats.

On Bill Grossman's higher markets and I was wondering to what extent was the decision to be able to bring on board driven exclusively by build familiarity with ARCUS programs. Thank you very much.

Merdad V. Parsey: Yeah, why don't you start Merdad? Yeah, thanks, thanks Umer. Great questions.

Yes.

Sure.

Thank you Bert.

Great question, Yes, we have not done the.

Merdad V. Parsey: Yeah, we have not done the interim PFS analysis as we've talked about. That'll happen certainly before the end of the year, we hope, and that's still what we're tracking too, but we have not done the analysis yet, so we remain blinded to the data. And then in terms of Bill, you know, I think I wouldn't necessarily tie it, as you're suggesting, to ARCIS. It's certainly an advantage for us that should we opt in to ARCIS programs, Bill will bring familiarity.

Interim PFS analysis, as we've talked about that that will happen.

Certainly before the end of the year, we hope.

And.

That's still what we're tracking to but we have not done the analysis yet.

So we remain blinded to those data and then in terms of bill.

I think.

I wouldn't necessarily tie.

As you are suggesting to rguest. It certainly an advantage for us that should we opt into ARCUS programs Bill will bring familiarity but.

Merdad V. Parsey: But for us, Bill's experience and leadership and his excitement about being here and overseeing the overall portfolio were the drivers for Bill coming on board. Yeah, and I would just add, Umer, I mean, look, many of us know Bill; you know him as well. Our relationship with ARCIS is extremely important and continues to be, and this was an example of Bill seeing a career opportunity and seeing an evolution of his career that made sense for him.

For us Bill his experience and leadership.

His excitement about being here.

And overseeing overall portfolio were the drivers for bill coming on board.

Just to add rumor I mean, many of us know Bill <unk>.

As well.

Our relationship with.

With ARCUS is extremely important and continues to be and this was an example of bill.

Seeing a career opportunity.

<unk> evolution for his career that made sense for him.

Merdad V. Parsey: We certainly want to make sure that ARCIS continues to have the skillset that it needs to be successful. We have the skillset that we need to be successful. I think it's just a good example of how partners collaborate at times. And so I just wanted to emphasize our relationship with ARCIS is unchanged and as strong as ever.

We certainly want to make sure that.

<unk> continues to.

Have the skill set that it needs to be successful we have the skill set that we need to be successful and I think it's just a good example of how <unk>.

Partners collaborate at times.

So.

I just wanted to emphasize our relationship with ARCUS is unchanged and as strong as ever.

Operator: Thank you. Our next question comes from Michael Yee with Jeffries. Your line is open.

Thank you.

Yeah.

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

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

Hey, Thanks for the question I appreciate it maybe a question for.

Our debt Entre delving, a couple of parts in.

In the tropics <unk> study you had the smart decision to take a look at that enlarge it powered for PFS etcetera did you have any information that could help give you confidence around the powering and and any information that would help you give confidence in your overall studies such as.

For more events that have passed or anything like that or even knowing that it had passed the futility. If you could even comment on that and then on the lung data that's coming up can you just comment around your belief in the profile versus the competitor is it similar efficacy better safety or how should we interpret that data when it comes later this year. Thank you.

Operator: And then on the long data that's coming up, can you just comment on your belief in the profile versus the competitor? Is it similar efficacy, better safety, or how should we interpret that data when it comes later this year? Thank you. Nice to hear your voice, Michael. Over to you, Merdad.

Nice.

The numbers back over to you yeah. Thanks, Michael on the on the tropics <unk> study.

Merdad V. Parsey: Yeah, thanks, Michael. On the Tropics II study, you know, we have not done a utility analysis. We are, We continue to look at these data maturing and getting the number of events that we need for the PFS analysis that we have planned. We're pretty confident in our powering, and in particular, since we expanded the sample size, to make sure that we are able to hit the PFS endpoint. Of course, the relevant issue is more the duration of the PFS that we get, but from a powering standpoint, we're comfortable, and it's just a matter of seeing the data.

You know we have not done a futility analysis.

We are.

We are we continue to look to those data are maturing and getting getting the number of events that we need.

Period.

For the PFS analysis that we have planned.

We're pretty confident in our powering and in particular since we expanded the sample size to make sure that we are able to hit.

The PFS endpoint of course.

Element issue is.

For.

The duration of PFS that we get but from a powering standpoint, where we're comfortable.

And it's just a matter of seeing those data from an ongoing event standpoint.

We are where we thought we would be at this point and it's really around just letting the events.

As more come in make sure they get adjudicated Lee.

Clean the data and time to do the analysis properly. So that's where we are with that and then.

In terms of the lung data.

On efficacy.

Yes, I mean, I think as I think we've said before where.

Proceeding.

At risk in pretty aggressively partly based on our belief in the drug partly because of what what we've seen with other agents.

In lung.

And partly based on our early data that youre familiar with in lung.

Merdad V. Parsey: And, of course, we want to make those data more robust while we go into the phase three world. So we are going to augment our existing data to make sure that we are mitigating our risk somewhat. But thus far, I think what we are hoping for is efficacy that is certainly comparable to what the benchmark might be, even though I think it's too early to say what that benchmark is with a direct competitor. But we are, again, I think, confident about our ability to bring a safety profile that hopefully will be better for patients.

We've seen of course, we want.

Want to make those data more robust.

We go into the phase III World. So we are going to augment our existing data to make sure that we are we are.

Mitigating our risk somewhat but.

Thus far I think what we are hoping for is efficacy.

<unk>.

We're really really is comparable to.

What the benchmark might be.

Even though I think it is.

Operator: Excellent. Thank you, Michael. Can we have the next question? Thank you. Our next question comes from Alicia Young with Cantor. Your line is open.

Excellent. Thank you Michael.

Sure.

Thank you. Our next question comes from Alethia Young with Cantor Your line is open.

Hey, guys. Thanks for taking my question I'm, just curious about again going back to the ARCUS collaboration that arc 7 how did you think about what the hurdle is for a triple do you think that it has to be more than like.

Alicia Young: Thank you. Our next question comes from Alicia Young with Cantor. Your line is open.

You know some of the competitors like Roche happened in double thing.

Thanks Lee.

I think we have the luxury of being able to look at the single a doublet and a triple here.

We would be of course excited at the triplet differentiates from the doublet and provides.

Better efficacy I think that's what we'd be looking for.

And so as the data mature looking for.

Some some signals.

A reason to believe that the triplet is performing.

More robustly than the doublet is probably going to be our focus we'd be very excited.

If that plays out it gives us I think a pretty unique position.

Operator: Thanks, Leith. Yeah, so I think we have time for one more question. And thanks, everybody, for your involvement. The last question, please.

Thanks Lee.

So I think we have time for 1 more question and thanks, everybody for your enrolment. So the last question. Please.

Operator: Thank you. And the last question comes from Ronnie Gallop Bernstein. Your line is open.

Thank you and the last question comes from Ronny Gal with Bernstein. Your line is open.

Hi, everybody and thanks for squeezing me in a question about the projections for HIV for the next couple of years.

Part 1 I guess as you change your reimbursement policy on 343 clinics next year.

How big essentially was is that difference in terms of what it creates for you and we won't Pls would it appear on revenue on SG&A.

And the second 1 you already mentioned the prep.

Barriers are dropping with preventative treatment designation for prep.

I can't figure out of this as good of debt for you from the perspective of.

Branded drug adoption given debt.

They don't have to cover branded drugs.

Thanks.

Thanks, Randy so over to you.

Johanna Mercier: Sure. Ronnie, I'm assuming you're talking about the Patient Assistance Program changes? Correct. Yeah. Okay.

Sure Ronny I'm, assuming you're talking about the patient assistance program changes correct, yes, okay.

Johanna Mercier: So I want to differentiate that. Those aren't 340B changes. That's actually a program that's really in line with our commitment to help end the HIV epidemic. To date, the program's actually provided free drugs to more than 250,000 individuals. And really, that's what it is. It's a free program that was always intended and will continue to provide free Gilead medication to eligible individuals to treat and prevent HIV. Unfortunately, it was not intended to be a source of funding for organizations to deliver services.

So I want to differentiate that those are at 340 <unk> changes that's actually a program that's really in line with our commitment to help end the HIV epidemic.

To date the program is actually provided free drive.

And 250000 individuals.

And really that's what it is it's a free program that was always intended and we will continue to provide fleet gilead medication to eligible individuals to treat and prevent HIV. Unfortunately, it was not intended to be a source of funding for organizations to deliver services and Thats what were trying.

<unk> can win to reset a little bit so the changes to our program mono.

We will protect our ability to be able to do this in the longer term and make it a sustainable program and for us and more importantly for patients. So that's the patient assistance program on that front.

And the question you were asking me about perhaps.

We're actually quite encouraged.

The <unk> that came out from the U S PSTN.

And here's why in the <unk> they provide a lot more clarity than they had in the past right. This isn't new the recommendation actually came out the portable care Act recommendation came out 2 years ago.

Johanna Mercier: The recommendation actually came out 2 years ago. But what this provided was actually more details on it and clarity on the importance of PrEP in ending the epidemic and minimizing the barriers of use. And there's a couple of things in the FAQ that popped out for me. One is, it truly supports physician and patient choice. And that's the piece where generics or non-generics, right? So Travada generics or DSCOVI would then need to be really the physicians and the patients get to decide together what is the right medicine for which patient.

But what this provided was actually.

<unk>, we have more details to add and clarity on the importance of prompt and ending the epidemic.

<unk> generics or disco V would then need to be.

Really the physicians and the patients get to decide together what is the right medicine for which patients and of course with the bone and renal safety benefits.

Johanna Mercier: And, of course, with the bone and renal safety benefits that DSCOVI brings, I think this is a great addition to the FAQs. In addition to that, there's also some guidance around timely management of the request for this by payers, so turning it around within 24 hours, which is quite different than what's happening today. And then the last piece is $0 of out-of-pocket costs.

Benefits that <unk> brings I think this is a great.

<unk> to the <unk>.

In.

Added to that there's also some guidance around timely management.

On the.

Johanna Mercier: So I think for patients, this is great news, and I also think for patient choice and physician choice, this is quite promising as well. Ronnie, I want to make sure we covered your question. Did we understand you correctly? I assume so, Ronnie.

In addition, this is great news and I also think for patient choice and physician choice. This is quite promising as well.

Ronny I want to make sure we covered your question.

John you correctly.

Okay.

The book.

Same store revenue.

Operator: Great. Well, thank you all very much. We appreciate your continued interest in Gilead and look forward to updating you on our progress.

<unk>.

Well, thank you all very much.

Yeah.

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

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

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

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