Gilead Sciences Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2024

There are 15 speakers on the call.

Operator

I'll now hand the call over to Jackie Ross, Vice President of Investor Relations and Corporate Strategic Finance.

Speaker 1

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the Q2 of 2024. 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 Chairman and Chief Executive Officer, Daniel O'Day our Chief Commercial Officer, Joanna Mercier our Chief Medical Officer, Mehrdad Parsi and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q and A, where the team will be joined by Cindy Peretti, the Executive Vice President of Kite.

Speaker 1

Before we get started, let me remind you that we will be making forward looking statements. Please refer to Slide 2 regarding the risks and uncertainties relating to forward looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.

Speaker 2

Thank you, Jackie, and good afternoon, everyone. I'm pleased to share that this was another strong quarter of commercial execution with growth across HIV, liver disease and oncology. Biktarvy for HIV treatment was up 8% year over year, Trodelvi was up 23% and cell therapy was up 11%. In addition, we continue to demonstrate disciplined operating expense management and delivered exceptional bottom line growth highlighting the leverage in our business model. Given the results for the first half of the year, we are raising our non GAAP operating income and EPS guidance for the full year.

Speaker 2

Moving to clinical updates, this is an important time for our virology and inflammation therapeutic areas. A key highlight of the quarter was the readout of our Phase 3 PURPOSE 1 trial evaluating Lenacapavir for HIV prevention. The results showed 100 percent efficacy with 0 HIV infections in cisgender women. The presentation of these results at AIDS 2024 in Munich generated considerable excitement and we're delighted to have reached this milestone with such a positive outcome. Lenacapavir with its twice yearly dosing could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen.

Speaker 2

The purpose program, which is expected to include more than 9,000 participants in over 10 countries, is designed to highlight the efficacy of HIV prevention in a wide range of groups, including cisgender women, transgender men and women, black and Latino individuals and young adults. We expect an update for PRRPUS-two late this year or early next year with a commercial launch as early as late 2025. The purpose data were part of several updates at AIDs 2024 that highlight the strength of Gilead's innovation in HIV for both prevention and treatment. Our pipeline has the promise to extend our HIV leadership well into the late 2030s and beyond. Updates at AIDs 2024 included data from our daily oral combination of bactegravir and lenacapavir, which is now in pivotal Phase 3 trials for people with HIV, including those on complex regimens.

Speaker 2

We also shared data from our broad long acting program, including our once weekly orals GS-four thousand one hundred and eighty two and GS-seventeen twenty. We plan to start the Phase 2 study evaluating these in combination before the end of the year. This in addition to the once weekly oral combination of lenacapavir and a slatravir in partnership with Merck that will begin Phase 3 also before the end of the year. On the immediate horizon, our PDUFA date for seladelpar is next week. The body of clinical evidence behind seladelpar for the treatment of primary biliary cholangitis or PBC continues to grow, most recently with the Phase 3 ASSURE data shared at EASL.

Speaker 2

The Gilead team is excited by the opportunity to launch seladelpar and bring a promising new treatment to the patients who could benefit. Moving to oncology, we are ready to manufacture ANITAcell from multiple myeloma at our Maryland KITE facility and we are preparing to support the Phase 3 IMAGINE-three trial from the site starting later this year. The IMAGINE-three trial is expected to reach a broader set of second to 4th line multiple myeloma patients with our potentially best in class BCMA CAR T. At ASCO, we shared new data from our Phase 2 EVOCO2 program evaluating Trodelvi in combination with pembro in first line metastatic non small cell lung cancer. The results showed meaningful efficacy compared to the historical standard of care supporting the Phase 3 evoC03 trial currently underway.

Speaker 2

We continue to assess the path for TRODELV in second line metastatic non small cell lung cancer and metastatic bladder cancer following the EVOQ01 and TROPICS-four readouts earlier this year. In the meantime, I'd highlight the strong commercial results this quarter in breast cancer, where Trodelbi remains the 1st and only approved TROP-two directed ADC on the market and is the standard of care for 2nd line metastatic triple negative breast cancer. To date, we have served over 40,000 cancer patients and remain confident that Trodelbi will continue to be an important treatment option. We also shared Phase 2 EDGE gastric data at ASCO for dombanilumab plus zembrolumab and chemotherapy in first line upper GI cancers. These results showed compelling efficacy that supports the Phase 3 STAR-two twenty one program, which has completed enrollment.

Speaker 2

Moving to our 2024 key milestones on Slide 6. We look forward to the upcoming updates from the Phase 3 ASCENT-three trial and Phase 2 IMAGINE-one trial. ASCENT-three is an event driven trial evaluating Trodelvi in first line PD L1 negative metastatic triple negative breast cancer patients. A positive progression free survival outcome would support global filings potentially moving Trodelvi into earlier lines of triple negative breast cancer. Our IMAGINE-one trial could support regulatory filings for Inida Cell in later line relapsed or refractory multiple myeloma.

Speaker 2

Overall, the Q2 was a strong performance for the Gilead team, with the highlights including some remarkable clinical results in HIV, solid revenue growth across therapeutic areas, tangible impact from our disciplined cost management initiatives and planning for the imminent launch of seladelpar. With that, I'll hand it over to Joanna.

Speaker 3

Thanks, Dan, and good afternoon, everyone. I'm very pleased to report the continued momentum we saw in the 2nd quarter and would like to thank the Gilead teams who contributed to another strong quarter of execution. As shown on Slide 8, total product sales excluding Vectlery were 6 point $7,000,000,000 in the 2nd quarter, up 6% year over year with growth across HIV, liver disease and oncology. Including Vekleri, total product sales were $6,900,000,000 up 5% year over year. Starting with HIV on Slide 9, sales of $4,700,000,000 were up 3% year over year, driven by strong demand across treatment and prevention, partially offset by lower average realized price due to channel mix.

Speaker 3

Quarter over quarter, sales were up 9%, reflecting favorable pricing and inventory build following the typical Q1 dynamics as well as higher demand. Looking to the full year, we remain on track to deliver HIV sales growth of approximately 4%. Turning to Slide 10. Total 2nd quarter Biktarvy sales of $3,200,000,000 were up 8% year over year, primarily due to higher demand. Sequentially, sales were up 10%, largely reflecting favorable pricing and inventory following the typical first quarter dynamics.

Speaker 3

Highlighting our leadership position, Biktarvy represents more than 49% share of the treatment market in the U. S. This was up almost 3% year over year, our 24th consecutive quarter of year over year market share gain. With a meaningful share lead over all other branded regimens for HIV treatment, Biktarvy firmly remains the HIV treatment of choice, particularly for those starting or switching regimens in the U. S.

Speaker 3

As well as across other major markets. Overall, the HIV treatment market continues to grow in line with our expectations of 2% to 3% annually. Turning to Descovy, we continue to see higher demand with sales of $485,000,000 in the Q2. Year over year sales were down 6% as demand growth was more than offset by lower average realized price due to channel mix. As a reminder, shifts in channel mix will continue to impact average realized price in addition to our ongoing efforts to ensure people who want or need PrEP have access to the prevention regimen of their choice.

Speaker 3

Sequentially, sales were up 14%, reflecting favorable inventory and pricing following typical Q1 seasonality in addition to the higher demand. Descovy for PrEP once again maintained its over 40% PrEP market share in the U. S. Despite the availability of other regimens including generics. We're particularly excited to note that the HIV PrEP market in the U.

Speaker 3

S. Continues to expand with total volumes up more than 12% in the Q2 of 2024 compared to the same period last year. With that in mind, we're thrilled with the unprecedented results seen in our pivotal Phase 3 PURPOSE 1 trial, achieving 100% efficacy with 0 cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating. This is just the beginning of our larger landmark purpose program, which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, Black and Latino individuals and young adults. Overall, we expect Lenacapavir will emerge as the regimen of choice for those who want or need prevention as the 1st and only long acting option with twice yearly subcutaneous dosing.

Speaker 3

We are preparing for potential launch as early as late 2025. Moving to the liver disease portfolio on Slide 11, sales were up 17% year over year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the U. S. Our liver disease franchise continues to differentiate itself with leading share in HCV despite fewer HCV starts year over year, together with growing demand in HBV and HDV. As you know, our PDUFA date for seladelpar is next week and we stand ready to launch commercially in the U.

Speaker 3

S. We are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring seladelpar to many of the 130,000 people impacted by PBC in the U. S. Who progress after initial treatment. Outside the U.

Speaker 3

S, commercial preparations are well underway and we look forward to the European regulatory decision in early 2025. Turning to Slide 12, while severity of COVID infections and hospitalization rates remain variable, VICLARE continues to be recognized as an important part of standard of care for hospitalized patients treated for COVID-nineteen. This includes the U. S. Where VACLARY has maintained well over 60% share in this setting.

Speaker 3

For the Q2, VACLARY sales were down 16% year over year and down 61% sequentially as expected. Moving to oncology on Slide 13, sales were up 15% year over year and up 7% quarter over quarter to $841,000,000 With over 60,000 patients treated with the Gilead or KITE therapy to date, we're proud of the positive impact our oncology medicines have made across multiple cancer types. Looking in more detail at TRUDELVI on Slide 14, sales for the Q2 were $320,000,000 up 23% year over year and up 4% sequentially, primarily driven by higher demand in the U. S. And Europe across its metastatic breast cancer indication.

Speaker 3

TRUDElvi is the only approved and available TROPE-two directed ADC to demonstrate clinically meaningful survival benefits across 2 types of metastatic breast cancers. And with increasing awareness amongst physicians, TRUDELLI has remained the leading regimen in the U. S. And Europe for second line metastatic triple negative breast cancer, with growing adoption in the pretreated HR positive HER2 negative metastatic breast cancer setting. We are working to expand Trudelby's reach beyond the 40,000 plus patients treated today across multiple tumor types as we look to new and existing markets as well as new indications.

Speaker 3

In bladder cancer, we are planning to further discuss the results of TROPICS-four and next steps with the FDA. At this time, Telvii continues to be available under an accelerated approval in the U. S. For 2nd line plus metastatic or advanced bladder cancer. Turning to Slide 15 and on behalf of Cindy and the KITE team, cell therapy sales in the Q2 were $521,000,000 up 11% year over year and up 9% quarter over quarter with solid growth in all regions.

Speaker 3

In the U. S, sales were up 11% sequentially as we've begun to see momentum from our focused efforts at the authorized treatment centers, including further educating providers and patients on the curative potential of our cell therapies. Despite these efforts, in class and out of class competition remain a near term headwind in the U. S. As we extend the reach of cell therapy, we're making important inroads with key community practices, including working with national payers to unlock broader commercial reimbursement, and as a reminder, expect impact from these initiatives towards the end of 2024.

Speaker 3

We'll continue to refine this blueprint as we work to onboard new centers and patients over time. Outside the U. S, demand for Yescarta and TECARTIS across Europe and other international geographies remain strong, and we're encouraged by the solid progress in our newly launched markets such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio and the teams are energized by the potential to bring 2 more transformational therapies to market. First, with seladelpar for PBC next week and then Lenacapavir for HIV prevention as early as late next year.

Speaker 3

And with that, I'll hand the call over to Murdat.

Speaker 4

Thank you, Joanna. We were very pleased to wrap up the Q2 with 2 New England Journal of Medicine publications and a number of important readouts across our portfolio. Most exciting was a readout of our Phase 3 PURPOSE 1 trial evaluating twice yearly subcutaneous lenicabivir for the prevention of HIV infection in cisgender women. As you can see on Slide 17, this was the 1st Phase 3 HIV prevention trial to ever achieve 100% efficacy. We have since shared data at the International AIDS Society meeting in July, where our presentation was the highlight of the plenary session.

Speaker 4

The data were simultaneously published in the New England Journal of Medicine. Our second registrational trial for Lenacapavir, PRRPISE 2, has enrolled approximately 3,300 men, trans women and non binary people who have sex with men. This trial completed enrollment globally in December 2023, approximately 4 months after PRPACE 1. As a result, we expect to provide an update in late 2024 or early 2025. Assuming positive data from PROPHEC-two, we plan to file based on data from both trials with the goal of bringing transformative HIV prevention to people at risk of HIV as early as late 2025.

Speaker 4

Beyond our registrational trials, we are generating Phase 2 data from the PURPOSE 3, 4, and 5 trials in key populations across the U. S, U. K. And France, including people who inject drugs. These trials reflect our commitment to evaluate Lenacapavir across diverse populations that could benefit.

Speaker 4

These studies are also intended to drive greater awareness among physicians and patients, including geographies where prevention options have not been affected historically. In addition to HIV prevention, we are of course intensely focused on next generation HIV treatment options. And Slide 18 highlights our comprehensive HIV treatment pipeline. Our recent updates at the AIDS Society meeting included longer term Phase 2 data from our once daily oral combination of bictegravir and lenacapavir that showed the regimen was highly effective in maintaining viral suppression. These results further support our ongoing Phase 3 studies in people with HIV, including those on complex regimens.

Speaker 4

We also reported safety and PK data for both GS-four thousand one hundred and eighty two, an oral prodrug of lenacapavir designed to provide 2 to 3 times greater oral bioavailability and GS-seventeen twenty, our long acting oral integrase inhibitor. Initiation of the Phase 2 trial evaluating the combination of these agents as a once weekly oral regimen is expected later this year. Additionally, we are on track to initiate our Phase 3 ISLEN-one and ISLEN-two trials evaluating once weekly lenacabavir in combination with Merck's islatravir. This regimen is expected to be the 1st once weekly oral treatment option. Looking at our longer duration treatments, we expect to provide Phase 1 updates from our every 3 month injectable programs and to initiate the Phase 1 studies for our potentially every 6 month integrase inhibitors in the second half of the year.

Speaker 4

Moving to our liver disease portfolio, on Slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the EASL Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open label Phase 3 ASURE study of seladelpar for PBC were consistent with the pivotal response study that formed the basis of our global regulatory filings. As you know, we expect an FDA regulatory decision shortly with a decision from European regulators to follow in early 2025. In viral hepatitis, Gilead shared final week 144 results of the Phase 3 MIR-three zero one trial at EASL. These data continue to support monotherapy belabratide 2 milligrams as a chronic treatment for HDV.

Speaker 4

Additionally, we presented promising Phase 2b data evaluating belabrutide 10 milligrams with interferon alpha 2a as a finite regimen. The post treatment response rates were the highest ever posted in HDV and were simultaneously published in the New England Journal of Medicine. We are encouraged by the data and continue to be engaged with KOLs and health authorities, including the FDA, as we work to bring belabrutide to patients as quickly as possible. Switching to oncology on Slide 20, we're pleased with the progress across our mid to late stage programs. In the frontline setting, we shared mature cohort A data at ASCO from our Phase 2 EVOCO-two trial with TRIDELBI plus pembro, demonstrating a median progression free survival of 13.1 months.

Speaker 4

These data exceeded the historical performance of PD-one monotherapy in first line PD L1 high non small cell lung cancer and support our ongoing Phase 3 of OCCO-three trial where enrollment is going well. In an all comer non small cell lung cancer population, our Phase 3 STAR-one hundred and twenty one study evaluating Dom plus ZYN is ongoing. Our Phase 3 STAR-two twenty one study in upper GI cancers evaluating Dom with ZYN and chemo has completed enrollment. The updated Phase 2 EDGE gastric data presented at ASCO supported the use of this combination. If successful, Dom plus ZYN and chemo would be the 1st digit based regimen for upper GI cancer patients.

Speaker 4

In addition, we have several Phase 3 programs underway in earlier settings of breast cancer, including ASCENO3 evaluating TRIDELVY and PD L1 negative metastatic triple negative breast cancer. Turning to our second line programs. We have discussed the results of EVOCO-one in metastatic non small cell lung cancer with regulators and as expected have confirmed there is no immediate regulatory path based on evoca-one alone. We're currently assessing next steps for Trudelphi in this setting. We will also provide updates on our bladder cancer program, including the full trial results at a future scientific conference after discussions with FDA and KOLs.

Speaker 4

Moving to Slide 21, and on behalf of Cindy and the KITE team, we shared updates for Yescarta and Tecartis at both ASCO and European Hematology Association meeting. At ASCO, we shared encouraging new efficacy data from a pilot study of Yescarta in 18 patients with relapsed or refractory primary or secondary central nervous system lymphoma in collaboration with the Dana Farber Cancer Institute. Yescarta demonstrated greater than 26 months median overall survival with no reported treatment limiting toxicities and no apparent additional risk of adverse events in these patients with high unmet need. Based on these results, we are engaging with regulators to expand the use of Yescarta to include these patients. Additionally, we reported that treatment with Tecartis resulted in a 40% 4 year overall survival rate and median overall survival of almost 26 months in the pivotal ZUMA-three trial in relapsed or refractory adult B cell acute lymphoblastic leukemia.

Speaker 4

At EHA, we shared preliminary analysis from the Phase 2 ZUMA 24 trial, further supporting outpatient use of Yescarta in relapsed or refractory large B cell lymphoma with the use of prophylactic steroids and other early intervention strategies. Real world manufacturing experience of Yescarta for second and third line large B cell lymphoma reinforces our strong manufacturing success rate of 96%. Further, on Slide 22, I will highlight our promising clinical development program for InedoCell, a potential best in class BCMA CAR T that we are developing in partnership with Arcellx. Notably, we shared our study design for our Phase 3 IMAGINE-three trial that will include a broader set of earlier line relapsed or refractory multiple myeloma patients. We expect to have first patient in for this trial in the second half of this year.

Speaker 4

We're pleased to note that the tech transfer and transfer of the U. S. IND of InitoCell to KITE are now complete. The KITE manufactured product will be used in IMAGINE-three trial and we anticipate the turnaround time for InitoCell to be on par with KITE's commercially available products. Wrapping up with our key 2024 milestones on Slide 23, we completed all of our first half milestones and are pleased with our program execution overall.

Speaker 4

We're off to a good start for the second half with the readout of PROPIS-one occurring ahead of our committed timeline. We look forward to the FDA decision next week seladelpar in PBC as well as an update from the pivotal Phase 2 IMAGINE-one trial in later line relapsed or refractory multiple myeloma in addition to an update on the pivotal Phase 3 SNO3 study in first line PD L1 negative metastatic triple negative breast cancer. Along with these updates, we have a maturing inflammation pipeline that includes several Phase 2 programs such as a once daily oral alpha-four beta-seven integrin inhibitor and an oral TIPL-two inhibitor for inflammatory bowel disease. And now I'll hand the call over to Andy.

Speaker 5

Thank you, Mehrdad, and good afternoon, everyone. Starting on Slide 25, the team delivered an excellent quarter with our base business up 6% year over year to $6,700,000,000 Product sales growth across HIV, liver disease and oncology more than offset the expected decline in Vectlury with total product sales up 5% year over year. Moving to our non GAAP results on Slide 26. Product gross margin was 86%, down 84 basis points from last year. R and D expenses were down 3% year over year, primarily due to the wind down of certain migrolumab, oveldesivir and TREDELVI studies following recent data and regulatory updates.

Speaker 5

Sequentially, R and D was down 5%, primarily due to the timing of clinical and manufacturing activities, partially offset by the initiation of new studies. These savings disciplined management of R and D resources towards the most meaningful opportunities. Acquired IP R and D was $38,000,000 reflecting new and ongoing collaboration payments in the Q2. SG and A was down 27% year over year, primarily due to the $525,000,000 legal settlement in 2023 that did not repeat in 2024. Excluding this payment, SG and A was up 2% year over year and includes commercial investments ahead of the launch of seladelpar.

Speaker 5

Operating margin for the Q2 was 47%, our strongest operating margin since the Q3 of 2022, highlighting the leverage we have in our business model. Turning to tax. Our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the 2nd quarter. On a reported basis, our non GAAP diluted EPS grew 50% year over year from $1.34 to $2.01 per share. As mentioned earlier, we had a $525,000,000 legal settlement, representing $0.32 per share in the Q2 of 2023 that did not repeat in the Q2 of 2024.

Speaker 5

Excluding this settlement, EPS grew 21% year over year, reflecting higher product sales and lower expenses, including acquired As highlighted on Slide 27, we had a strong first half of the year with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year over year, which is at the upper end of our full year guidance of 4% to 6%. Switching to our expectations for 2024 on Slide 28. We continue to expect total product sales in the range of $27,100,000,000 to $27,500,000,000 and total product sales, excluding VAKLURE, in the range of $25,800,000,000 to $26,200,000,000 Given the inherent variability experienced historically and as stated previously, we are not updating our Vectlori guidance at this time. As we think about the second half of the year, here are some of the factors that we are continuing to monitor. First, we continue to expect the normal quarter to quarter variability in our HIV business that we have always experienced relative to average realized price associated with channel mix.

Speaker 5

2nd, we expect quarterly variability in cell therapy due to continued in class and out of class competition. 3rd, there is some uncertainty associated with TRIDELVI bladder revenue following TROPICS 4. As a reminder, bladder represents less than 10% of total TRIDELVI sales today. And finally, there is a possibility of incremental FX headwinds in the second half of the year. For the rest of 2024, we continue to expect to deliver strong volume growth across all therapeutic areas and assuming approval seladelpar as an incremental contributor to revenue growth.

Speaker 5

Continued HIV volume and revenue growth, consistent with our full year expectation to grow HIV product sales by approximately 4% and continued focus on disciplined operating expense management. Moving to the non GAAP guidance. There is no change to our non GAAP gross margin range of 85% to 86%. For R and D, we now expect total R and D expense to increase by a low to mid single digit percentage compared to 2023, reflecting lower than previously expected R and D expenses in 2024, despite absorbing the late stage seladelpar program. For SG and A, there is no change to our prior guidance pointing to a mid single digit decline compared to 2023.

Speaker 5

Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the Simba Bay transaction. For acquired IPR and D, we now expect full year expenses of $4,700,000,000 up from $4,400,000,000 last quarter to reflect a $320,000,000 transaction with Janssen to buy out the global seladelpar royalty. This expense will be included in our Q3 results. Finally, with the strong operational expense control demonstrated in both the first and second quarters and despite this new 3 $20,000,000 acquired IPR and D expense, we are increasing our operating income guidance to $7,200,000,000 to $7,600,000,000 and increasing our non GAAP diluted EPS guidance to $3.60 to $3.90 Slide 29 highlights that the increase to our EPS guidance fully absorbs the $320,000,000 or approximately $0.20 per share expense associated with the buyout of the seladelpar royalty from Janssen. This transaction removes Gilead's royalty obligation to pay 8% of seladelpar sales.

Speaker 5

Excluding this transaction, our EPS guidance increase would have been even more significant today, up $0.30 or 8% at the midpoint, again highlighting the financial discipline that has translated into operating leverage. Moving to Slide 30. We continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities. In the Q2, we returned $1,100,000,000 to shareholders, repaid $1,750,000,000 of senior notes and paid $1,200,000,000 as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017. The remaining transition tax payment of $1,300,000,000 is scheduled for April of 2025.

Speaker 5

Overall, we believe that Gilead is well positioned for near and long term growth, and we continue to be focused on commercial execution, expense management discipline and to delivering on our strategic commitments. And now, I'll invite Rebecca to begin the Q and A.

Operator

Thank you, Andy. At this time, we'll open up the call for questions. We ask you to be courteous and limit yourself to one question so that we can get to as many analysts as possible during today's call. Go ahead. Your line is open.

Speaker 6

Hi there. This is Evan Seagram from BMO Capital Markets. I wanted to touch on TIGIT. There's been a lot of updates in the TIGIT space. I know after ASCO, we had the Roche update and most recently Merck discontinued their Keyvibe study in small cell lung cancer.

Speaker 6

So Merdette, maybe you could just walk us through how you think about the opportunity for TIGID and what looks good what good would look like for you in terms of both safety and efficacy with the STAR-one hundred and twenty one program? Thank you so much.

Speaker 4

Thanks Evan for the question. Yes, I think as you noted there have been a lot of updates on TIGIT over the past 6 months or so. And I think that gets to our approach, which I think is somewhat differentiated from our competition in that. As we've said out long, we have a differentiated molecule first off and that is that we have an Fc silent molecule relative to an Fc active molecule that the competition has. And, we've note I would note that, that is demonstrating a difference in terms of the adverse event profile, including the data that were highlighted today.

Speaker 4

Additionally, I think we've tried to stay focused in areas where we believe that there is the best chance of activity. And so for example, we have not initiated any trials with small cell. We look forward to capitalizing upon the data we have seen so far both in non small cell lung cancer and gastric cancer. As you know, we provided an update on the EDGE Gastric study at ASCO. And as I noted in the call, we have completed enrollment of that of the Phase 3 in in a data driven way based on the data we've generated in our trials so far.

Operator

Our next question comes from Terence Flynn at Morgan Stanley. Go ahead. Your line is open.

Speaker 7

Great. Thanks for taking the question. Two part for me. Just, Mehrdad, wondering if you can help frame expectations for the PROPUS-two trial, just given this is a slightly different population relative to PROPUS-one, so just as we think about level setting there, ahead of that data. And then the second part is for Joanna.

Speaker 7

So obviously, you guys noted that you've seen growth in the prep market recently, which is encouraging. But what other steps can you as a company take to maybe help alleviate some of the payer roadblocks that are really still in the way of branded prep use given the still high level of generic Truvada use? Thank you.

Speaker 4

Thanks, Terence. I'll start and then I'll hand it off to Joanna. As you said, It's a great question and a good thing for us to make sure that everyone remembers. Our purpose 1 was the trial that was in cisgender women. And as I noted, purpose 2 is our ongoing study in the cisgender gay men, transgender women and men and gender non binary people.

Speaker 4

Now that study is ongoing. It is the 2nd trial that's necessary for filing. And like purpose 1, purpose 2 is designed to evaluate the superiority of Lenacapavir against background HIV rates. That's the primary endpoint and the secondary endpoint would be similar to PROPIS. 1 will be superior to Truvada as a secondary endpoint.

Speaker 4

So, once we if hopefully we demonstrate a positive result in PRPUS-two, we would combine those data with PRRPIS-one and, move as quickly as possible to filing those data to, lenacapavir for Prat.

Speaker 3

Great. So maybe just to complete the second part of that question around the growth in PrEP and what the opportunities lies ahead, despite some of the payer roadblocks that you were referring to. Just a couple of points on that. One is, today the market for PrEP is growing at about 12% or so year on year. So nice consistent growth that we've seen over the last couple of years.

Speaker 3

Descovy's coverage is over 90% of all lives are covered from an access standpoint. So today, the daily orals do not have any concerns from an access standpoint. I think maybe what you're referring to is potentially as we think about medical benefits versus a pharmacy benefit that might create a little bit more access headwinds from a payer standpoint and we've seen that already with some of our competitors. As we think about Lenacapavir, in light of not only the data just most recently with Purpose 1, but also just the profile that it offers with a twice yearly subcu, I think it really allows us to redefine the prep market as a whole. And as much as we're seeing today maybe over 400,000 users in the U.

Speaker 3

S, we really see 3 major growth opportunities. 1 is around market size growth, the other one is around market share growth And the third one is on adherence. So if I just break those down a little bit, the market size growth is around reaching more users, so well beyond just white MSMs, thinking about cisgender women, transgender men and women, Latino black individuals as well as young adults. Reaching more prescribers in different settings than we are today. And over time reaching more countries, right, because right now PrEP revenues are really coming primarily out of the United States.

Speaker 3

From a market share growth standpoint, Descovy is the number one branded daily oral today with over 40% share. And we believe lanycalfiuria will be number 1, from a long acting standpoint. And between the 2 together, we believe the Gilead presence in HIV prevention will also be leading and greater than where we are today. And last but not least is higher adherence. And that just has to do with a domestic the frequency administration.

Speaker 3

When you think about a twice yearly subcu has much higher adherence than a daily oral and obviously better outcomes. So all those pieces together is what we are focused on as an opportunity for the future of prevention with not only Descovy, but obviously with lancapivir around the corner potentially. And from an access standpoint, we are thinking ahead as we think about even the work that CMS is doing when they think about making it a Part B drug for medical benefit in prep to ensure greater access. But we're also thinking through how is this going to impact from both from a prescriber standpoint and how do we support that reimbursement challenges that I think others have been facing and how we basically do a very high touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

Operator

Our next question comes from Leerink Partners. Go ahead. Your line is open. Hi. Thanks for the question.

Operator

I want to ask on anetoscel, a 2 part. One is just a process factual. I wonder if you can confirm whether you have completed enrollment in IMAGEN-one and thus what kind of follow-up time we can expect in the data, should it be accepted at ASH? And then a deeper question on IMAGEN-three. I wonder what your approach is in IMAGEN-three to bridging therapy so as to avoid the higher risk of death that was observed in the competitor trials soon after enrollment.

Operator

Thank you.

Speaker 2

Thanks, Dana. So we've got Cindy Peretti here. We'll turn it over to her to answer that. Thanks for the question.

Speaker 8

Thanks, Dana. We continue to be really excited about the potential with INITASAL with its best in class profile. And our enrollment target for IMAGEN-one has been met. I think the second question you asked is what type of follow-up would we expect to see at ASH? And I think we're in the process of we did an initial cut obviously for the abstract, we'll do a second cut, for the final sharing of the data.

Speaker 8

So I don't have the exact follow-up time, but we can certainly look to follow-up with you once we have that. Your second question was around IMAGEN3 and bridging therapy. Right now, we will be moving so we were able to complete the tech transfer as you heard from Dan, into our Maryland production facility. So we will be supplying therapy out of our Maryland facility and we expect to apply a lot of the learnings that we have with our existing products on the market today and be able to get an INITA Cell back to those patients, in IMAGINE 3 as it relates to having time upfront to do bridging therapy. However, with the protocol design today, we do have the option to do bridging therapy if necessary for patients.

Operator

Our next question comes from Umer Raffat of Evercore. Go ahead. Your line is open.

Speaker 9

Hi, guys. Thanks for taking my question. I'm very intrigued about your lenicaprevir plus bictegravir trial heading into Phase 3. And I'm just trying to understand, could this regimen possibly replace Biktarvy to a meaningful extent? Or would you rather have some sort of a low dose nuke in that combination as well as a second alternative?

Speaker 9

I'm just thinking back to some of the Dovato experiences as well. Thank you very much.

Speaker 3

So maybe I'll take that one, Umer. So the LENVICT combination is a single treatment regimen that really combines a best in class integrase inhibitor with a 1st in class capsid. The studies that we are doing both Phase 2 and 3 are really first we looked at the complex regimen, which that was kind of the first step. And as we go into Phase 3, we believe we can get a broader label indication to also include all virologically suppressed. So as we think about, that opportunity, we think it's an opportunity for an FTR that's optimized, simplified for complex regimen, but also provides optionality in the viral degree to suppress the switch segment of the marketplace.

Speaker 3

So as we think about it as a portfolio perspective, we still believe that today Biktarvy is the standard of care and will remain as the standard of care from a daily oral standpoint. But we also think that's an opportunity in the switch segment. So naive is a big piece, probably the biggest piece for Biktarvy's growth. And the switch because we have such a large share obviously, right? So from a switch segment that offers us another opportunity for us to play in a bigger market space in HIV.

Operator

Our next question is from Carter Gould at Barclays. Go ahead Carter. Your line is open.

Speaker 10

Great. Thank you. Good afternoon. Thanks for taking the question. Maybe another one on purpose 1.

Speaker 10

So again, yes, the efficacy was very impressive. However, we did see that north of 20% of patients did have nodules out to week 52. And I guess for Joanna, as you think about that profile in this setting, recognizing they were only Grade 1, but sort of the long term nature of those nodules, how do you see that influencing or impacting the profile, its demand and the potential for those patients then go back and get retreated after 6 months? Thank you.

Speaker 3

Sure. And Carter, just to explain a little bit, the nodules are because it's a drug depot, right? So the nodule actually gets smaller over time. What we've seen is actually very little discontinuation in purpose 1 due to that. That's number 1.

Speaker 3

2 is the nodules are sometimes palpable, not all, but sometimes palpable but not visible and generally speaking. And so we believe that actually, we will have some flexibility as well as to where those injections play out and when because I think they've been studied in different places, not just in the stomach, inside. And so I think that'll be an opportunity as well for people to be a little bit more flexible as to where they get their injections. So we're not overly concerned there at all. Actually, and really we're taking it from the data that we're getting from PRRPIP1 and hopefully we'll have similar data to learn from PRRPIP2.

Operator

Our next question comes from Mike Yee at Jefferies. Mike, go ahead. Your line is open.

Speaker 4

Thank you, guys. We have one question on long acting HIV, specifically the potential for a Q6 month, which I think could be a game changer. I think you have 1 or 2 of them on your slide and they are advancing. Can you tell me your confidence level on what you have there? Because if you follow HIV development, you know that if it's generally safe and more tolerability, significant barrel load reduction, you're in a pretty good spot in Phase onetwo?

Speaker 4

Thank you. Let me know. Hi, Michael. It's Bartad. Thanks.

Speaker 4

Yes, I think you raised the right question, which is that whenever we're looking at the long acting, new long acting agents, we have to be cautious about the transition from preclinical to clinical. We don't we're not always able to predict the injection site reactions that you might get from the long actings in particular. We were just talking about the nodules for Lenacapavir, but other more severe injection site reactions and then the human pharmacokinetics. So I think we need those to play out to allow us to move forward and that's why you see multiple agents going into Phase 1. We've generated a number of molecules.

Speaker 4

We move them forward. We've been pretty aggressive in moving them forward in order to maintain our leadership in long acting HIV treatment and prophylaxis. And so once we start to see those data in Phase 1, I think that will help us decide both choosing between those molecules and where we want to go forward. Remember, we're also moving our BNAP program forward, which will be our which is our most advanced long acting program with linacathabir plus bnabs and we should we expect to get Phase 2 data from that study as well. So for those early programs, it's the usual risk and which is why we take multiple shots and hopefully, we'll be able to advance one of them quickly.

Operator

Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open.

Speaker 6

Hi there. Thanks so much for taking my question. You guys have an oral GLP-one, GS-four thousand seven hundred and fifty one in your preclinical pipeline. Are you planning to move it forward? And as you continue to diversify the portfolio, how are you guys thinking about the obesity landscape and potentially participating?

Speaker 6

Or are there other metabolic areas and adjacencies that you may be more interested in pursuing? Thanks.

Speaker 4

Thanks, Brian. Yes, we have shared some preclinical data on 4,571. As you note, it is an internally developed oral GLP-one agonist, which came out of our initial interest in our NASH program. And based on the data so far, both preclinical and the tox data, we are planning a Phase 1 study for that molecule and that will help us evaluate, 45, 71, for weight management, obesity and other metabolic diseases. Once we generate those data, we will decide in a data driven way how best to proceed from there.

Speaker 4

And we'll just have to see how that plays out. We want to make sure if we develop something, it's best in class and allows for a best in class profile. So we'll update more as the data are generated.

Operator

Our next question comes from Chris Schott at JPMorgan. Chris, go ahead. Your line is open.

Speaker 11

Great. Thanks so much. My questions were just or question was just on the U. S. CAR T franchise.

Speaker 11

Just wanted to get your latest view on how we should be thinking about sequential growth from here? And maybe as part of that, can we just get an update on kind of your community physician engagement with the CAR Ts and any leading indicators that you're seeing there that help could maybe guide some of the efforts or the when we could start seeing the impact from some of these efforts in the U. S? Thank you.

Speaker 8

Thanks, Chris. We are really pleased with our strong cell therapy growth this quarter. And this is really part and parcel to our U. S. Refresh strategy.

Speaker 8

So as a reminder, we restructured our sales team at the end of last year. We got our new sales team in place and trained and ready to go. And as part of that strategy, we also focused, for the next couple of quarters on really within the authorized treatment centers, making sure those referrals occur between the lymphoma specialist to the CAR T specialist. And that's what you're seeing as part of the excellent performance that we had this quarter. And we'll continue to deliver and really focus on the referrals within the ATC.

Speaker 8

We're also in parallel building up that those community practices and spending time educating both the community practices, I'd say regional hospitals and those institutions about the curative potential of CAR T and why it's important to bring this into the therapies that they're offering to their patients. And we're making really good progress there, including a lot of work with national payers. But despite all of this, as you heard earlier from both, Dan and Johanna, we are facing it's a dynamic market. We are remaining cautious for the second half of this year as we continue to see some competitive headwinds, both in class competition. So we have new indications that came out in late May, early June timeframe, which are capturing physician mind share initially.

Speaker 8

And we're also seeing out of class competition with the bispecifics. But with all of that said, we are focused on execution and working with our physicians and institutions to raise awareness of the curative potential for CAR T and we'll continue to do so the second half of this year. As it relates to community practices, I shared last quarter that it's taking us a little bit longer than we had expected to get them up and fully operating, but we're making great progress as it relates to that and learning a lot along the way. So we're continuing to refine, our blueprint as we onboard new centers.

Operator

Our next question comes from Steven Seedhouse at Raymond James. Steve, go ahead. Your line is open.

Speaker 12

Yes. Thank you very much. Just given some of the newer tailwinds outside of oncology, so lenacapavir, obviously, which you indicated could redefine the prep market and then seladelpar, of course, as well. When you just combine that with the updated view of oncology pipeline, are you still expecting the 2,030 revenue mix to be about a third of oncology? Or is that more of a moving target?

Speaker 12

Just hoping you could comment on the long term outlook? Thank you.

Speaker 2

Yes. Thanks, Stephen, for the question. So 1 third of sales remains our target with the portfolio that we have today and which we believe is achievable without additional BD. I'll just remind you, we keep in mind that the indications in that target are probability adjusted and many of them around 50%. So, you'd expect to see puts and takes in that pipeline evolution.

Speaker 2

We certainly expected that when we set that target. So it allows for some programs to fail or fall short of initial expectations and others, obviously succeed to support achieving that goal. I would just note that oncology sales today are already more than a third of the way there. In quarter 2, 2024, there are about 12% of the total product sales growing nicely. So it's highlighting the progress we're making on this overall goal.

Speaker 2

I think you're right to point out also the progress in the and as you put it, the tailwinds with our virology business and my capivir data as well as seladelpar. Obviously, as that grows, that puts even more stretch to our ambition. It's a good problem to have. But I think the ambition we have is very much along the lines of diversifying our business as well as solidifying our base in virology and we're firmly committed to that strategy.

Operator

Our next question comes from Tim Anderson at Wolfe Research. Tim, go ahead. Your line is open.

Speaker 13

Thank you. I have a question on the TRO2 space. So sometime before or around your end, we'll get your Phase 3 first line triple negative readout with TRIDELVIEW from the ASCENT 3 trial. And we'll also be getting Astra's Tropian Breasto II and the design of those trials are quite similar, which will allow probably for the best side by side comparison thus far of your drug versus Astra's. Astra's.

Speaker 13

And I'm sure you've thought about this a lot. What's your prediction for how those results will likely stack up against each other? I'm guessing you'll show less ILD as one benefit, but how do you think efficacy and other safety metrics will compare?

Speaker 4

Sure. This is Murdock. Maybe, look, I think you hit the highlights. We are Tridelby has demonstrated great efficacy in the triple negative breast cancer space and we remain, I think, the only approved trip to ADC and that space in triple negative is definitely where Tridelvia is doing very well and has become standard of care for most physicians. So I think that sets us up nicely.

Speaker 4

And ASCENTO-three, as we update the status of that trial as the end of the year rolls around, I think we'll be part of the continuation of that story and our expectation for Trudelby's success in triple negative breast cancer. We have felt that there are areas where our programs are differentiated and for Trudelby as you mentioned, our adverse event profile has remained largely predictable and very manageable on the part of physicians. We certainly, both the ILD you mentioned as well as stomatitis have been very different in their manifestations and mostly for TRILVI it's been neutropenia and diarrhea, which I think clinicians have gotten very comfortable with managing certainly when we speak to

Speaker 11

our KOL.

Speaker 4

So we'll be looking for those data and we'll look for our data particular and I think it's a continuation of where we think Tridelbi can go and really solidify our position in triple negative breast.

Speaker 3

Yes. I would just reemphasize what Mehrdad said. I think just the fact that we are the ones on the market today and so well established as the number one standard of care in triple negative breast cancer second line, I do think that, that is a big differentiator as we think about some of these data points.

Operator

Our next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead. Your line is open.

Speaker 14

Thank you. Good afternoon, everyone. With regard to the long acting program, could you speak more about potential read through from purpose 1 to purpose 2? And whether there are typically any differences in responses to HIV drugs in these different patient populations? And regarding the strategy to expand the prep market, could you speak to specific strategies here and why you haven't been able to reach these patients already?

Speaker 14

Thank you.

Speaker 2

Thanks, Salveen. It's kind of a 2 part. So I'll have my dad start and maybe Joanna add as well.

Speaker 4

Yes. Salveen, you're absolutely right that patient populations are different. This is why we did the broad purpose program to really get a diversity of patients early in our program to ensure that we can bring PrEP to a variety of populations early on in our development. The patient populations are different. We're talking really cisgender women relative to the PRRS2 population, which is a different population.

Speaker 4

And our expectation is that those populations have different levels of awareness, different levels of compliance in their use of PrEP otherwise, for example, with the oral PrEP agents. And despite that, I think the strength of the PROPUS-one data and the fact that you have people who are essentially protected for 6 months with no infections occurring in the cisgender women so far, I think give us a lot of confidence that with I would expect some variability in the background infection rate in the population. If we are able to maintain that degree of protection and purpose too, we remain really confident that the outcome will be very powerful.

Speaker 3

And maybe to pick up on the second part of that Salveen. So just to take a step back, I think it's important to understand how much we have moved the needle actually when you think about the penetration in the prevention market. Just a couple of years ago, you're about 25% penetration when you if you consider it from a CDC standpoint estimate. We're now over a third of that. So we have really grown this market and expanded it.

Speaker 3

I think one of the challenges has definitely been this is not a typical market that you it's not HIV treatment. It is a market where these are individuals that are not sick. They have no asymptomatic, obviously, they have nothing. And so therefore, it's very challenging when you think about a daily oral pill, which is today over 95% of the total market, where you think about current generics or DescovyShare. And taking a pill every single day is incredibly challenging.

Speaker 3

So many use prep on demand and I do think there's and in that, the biggest population that we see are actually white MSM, so very much a high commercial market here. And we believe that there's a real opportunity to with something that has the profile of Lenacapavir with a twice yearly subcu that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future. And so that's kind of the step. So I think it's an ongoing growth that we've been seeing. I think we have to do a step change here as we think about the future of prevention.

Speaker 3

I think we have to think completely differently about what Lenacavivir could offer all of these people and really make a dent in this HIV epidemic.

Operator

Our last question comes from Olivia Breyer at Cantor Fitzgerald. Olivia, go ahead. Your line is open. Our next question comes from James Shinn at Deutsche Bank. James, go ahead.

Operator

Your line is open.

Speaker 11

Hey, guys. Thanks for the question. For PrEP, is the move to Part B a net positive to access? And when LEN is eventually approved for PrEP, do you expect the market to remain mostly a buy and bill? Thank you.

Speaker 3

Sure. I'll take that one. So the move, the NCD for PrEP that CMS is working on, I do think it's positive. I think it's really around providing greater access and potentially providing also the services that go with it. So D2B could actually be a nice move despite the fact that today Medicare is a very small piece of the total prevention market.

Speaker 3

As we think about Lenacapavir, I think it'll be both. I think there's probably opportunities for it to be both a pharmacy benefit as well as a medical benefit and be a buy and bill. And I think we just need to think very differently because buy and bill in the current users of prevention, this is not something that they're familiar with. And so this is something we're really thinking about today for tomorrow as to setting up that system to make sure they understand how to do this if they want to do it, but that they have an option if they don't want to do it. And I think that's what we're kind of planning for as we think about the future of lenacapavir.

Operator

That completes the time that we have for questions. I'll invite Dan to share any closing remarks.

Speaker 2

Thank you, everybody. In closing, we, the team here, would like to summarize the quarter as follows. We had a very strong quarter of revenue growth and impressive bottom line growth that highlights the leverage in our model. Secondly, we made progress that should enable us to build on that growth in the future including really remarkable data from the PROPUS-one trial and from across the HIV portfolio with the promise to extend our HIV leadership well into the late 2030s and beyond. The imminent launch of seladelpar in the U.

Speaker 2

S. And continued progress in oncology. And all of this leaves us well positioned for the second half of twenty twenty four when we will continue to focus on quarter after quarter of strong clinical, commercial and financial execution. My thanks to the Gilead teams and to all of you for joining today. I want to hand it over to Jackie Ross for some final comments.

Speaker 1

Thank you, Dan, and thank you all for joining us today.

Operator

One final housekeeping item. I can share

Speaker 1

that we are tentatively planning to release our Q3 2024 earnings results on Thursday, November 7. Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of Q3. We appreciate your continued interest in Gilead and look forward on updating you on our progress throughout the quarter.

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Earnings Conference Call
Gilead Sciences Q2 2024
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