Q2 2025 Gilead Sciences Inc Earnings Call
Good afternoon everyone and welcome to Gilead's second quarter 2025 earnings conference. Call. My name is Rebecca and I'll be today's host in a moment. We'll be begin our prepared remarks.
Followed by our Q&A session to ask a question. Please press star 1 to withdraw, your question, press star 2. Now, I'll hand the call. Over to Jackie Ross, senior vice president of Treasury and investor relations.
Thank you. Rebecca just after market closed today. We issued a press release with earnings results. For the second quarter of 2025. The press release, slides and supplementary data are available on the investor section of our website at gilead.com.
The speakers on today's call will be our chairman and chief executive officer. Daniel, eau de our chief commercial officer, Joanna Mercier, our chief medical officer, dmar burger and our Chief Financial Officer Andrew Dickinson.
After that, we'll open the call to Q&A, where the team will be joined by Cindy Petty, the Executive Vice President of Kite.
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.
Thank you, Jackie and good afternoon everyone. The team and I are pleased to be here with you today to share the results of a very successful second quarter.
This quarter had special significance, of course with the FDA approval of Atlanta, capir or yes, to go for twice yearly, HIV prevention.
I want to take this opportunity to thank the many people who contributed to this remarkable achievement from the Gilead, teams who discovered and developed Lana cave to the participants in the purpose studies, as well as The kl's Advocates Community Partners and others who have been part of the Lena cap of your journey,
This is truly a milestone moment in the history of HIV with the launch of a groundbreaking Innovation that could Bend The Arc of the epidemic.
Moving to the quarterly results, we had another very strong quarter of clinical commercial and operational execution.
Excluding the glory based business sales of 6.9, billion dollars grew 4% year-over-year driven by robust growth across big tarvey. The scoby lived, Eli and trade elvi.
Product sales of 7.1 billion grew 2% year-over-year.
performance with partially offset by lower Victory sales, due to fewer Co 19 Reed, hospitalizations
HIV had a very strong second quarter with dandr driven, growth of 7% year-over-year more than offsetting the anticipated. Headwinds from the Medicare Part D redesign.
Victoria grew 9% year-over-year to 3.5 billion and the scoby grew 35% year-over-year to 653 million.
This was the company's strongest quarter ever, highlighting the growth of the HIV prevention market into which we are now launching. Yes, to go.
It is now 7 weeks since FDA approval of yes, to go. And we are very pleased with what we're seeing so far.
Johanna and Andy will take you through our results in more detail. But overall the strong commercial execution and operating expense discipline, year to date, support higher expectations, for the second half of 2025.
As a result, we are increasing our revenue and EPS guidance for the full year.
Perspective. The second quarter was 1 of the strongest in Gilead's history.
in addition to the FDA approval of yet to go, we received a positive chmp opinion from the European medicine agency,
With more than 1 million new HIV infections globally, each year and over 600,000 HIV related deaths. We Believe Lena capir is 1 of the most important scientific breakthroughs of our time, which brings a sense of urgency and responsibility to reach the communities most in need as quickly as possible.
At the same time, we continue to fully evaluate Lena, Cap's potential in the clinic.
For example we have just initiated purpose 365 a phase 3 trial evaluating once yearly Lena cap of year for prep.
Additionally, we continue to develop seven combination regimens that utilize lenacapavir-based molecules for HIV treatment.
In the second half of the year, we plan to share updates from Artistry 1 and Artistry 2.
These phase 3 trials are evaluating a potential new single tablet, regimen combining bigger, beer plus lent cap are that could further extend the reach of Gilead's current HIV treatment business.
Moving to oncology, we announced back-to-back positive phase 3 results for trade, elvi with the Topline data, from asento 3, and the detailed data from asento 4.
We now have data that show, highly statistically significant and clinically meaningful benefit for Trevi, across first-line, metastatic, triple negative breast cancer
Tranelli is already the leading therapy for second line, metastatic tnbc. And with these data we look forward to potentially advancing trade delvi to the first line setting where it could benefit twice as many patients.
In Cell Therapy. We expect to provide a pivotal update from The Phase 2. Imagine 1 trial evaluating a need to sell for multiple myeloma later this year.
Given the compelling, efficacy and safety data, seen to date combined with kites industry-leading manufacturing capabilities. We believe a need to sell is, well, positioned as a potential best-in-class therapy for multiple myeloma.
In summary, this is a very special time for Gilead. That's underscored with our second quarter results.
This highlights the strength of our R&D engine and the level of excellence in our commercial and operational execution.
Having built this positive momentum, we're excited by. What's to come with continued Innovation, that will benefit patients and drive growth across our therapeutic areas.
With that, I'll hand over to Joanna.
Thanks Dan and good afternoon everyone.
We had another very strong quarter of commercial execution, culminating in the launch of Hugo following FDA approval in late June.
Second quarter, product sales, excluding vicary of 6.9 billion, we're up, 4% year-over-year, primarily driven by 9% growth in Victoria and 35% growth in Discovery.
We also delivered encouraging contributions from live dowi in its third full quarter of commercial launch and in delvi. Partially offset by lower. Hcv sales following a very strong second quarter in 2024.
Sequentially sales in our base business were up. 10% driven by growth in HIV oncology and deliver disease.
Including vetory total product sales of 7.1 billion dollars or up 2% year-over-year.
While victories share of us, hospitalized patients treated for Co 19 Romaine. Well over 60% the number of patients impacted by the pandemic continues to decline.
This is reflected in second quarter, sales of 121 million for victory and also in our updated full year guidance.
moving to slide 8 HIV sales of 5.1 billion dollars represented very strong 7% year-over-year growth
Primarily driven by increased demand in addition to higher average realized price.
Sequentially sales were up 11% reflecting inventory, build and higher average realized price both typical second quarter, seasonal Dynamics as well as higher demand.
On slide 9 Vari sales of 3.5 billion dollars, were up 9% year-over-year with commercial execution, supporting a strong increase in demand.
Sequentially sales were up, 12%, reflecting seasonal, inventory, build, and higher, average realized price as well as higher demand.
Vicari once again expanded. Its US market share and increased 2 percentage points year-over-year to over 51%.
Further, strengthening victory's differentiation FDA recently granted, a label expansion to include the treatment of HIV in people with anti-retroviral history, who are not biologically suppressed with no known or suspected resistance.
This new indication addresses, an important unmet need for people with HIV.
Specifically, those who come off therapy and then restart treatment.
This label expansion reinforces confidence in Victoria to get such individuals to sustained viral suppression.
Moving to Discovery, second quarter sales of 653 million, increased 35% year-over-year with growing awareness of prep and unrestricted. Access Driving, both higher, average realized price and higher demand.
Sequentially sales were up, 11% reflecting seasonal, inventory Dynamics and higher demand.
Partly driven by strong execution, from our commercial teams and continued growth ahead of the sdo launch. The ux prep Market has now expanded to more than half a million active users,
This Market continues to grow in the mid-. Teens year-over-year, highlighting progress. On our goal of expanding the HIV prevention Market.
Additionally discoe for preps. Share grew. Once again this quarter representing more than 40% of the US market.
Moving to slide 10, we received FDA approval of yes, to go as the first twice yearly injection for HIV prevention in mid June.
And the team has been executing. What I consider to be the best plan commercial launch. I had seen today
Revenue in the first days of launch, right? At the end of the second quarter, reflected planned inventory bills as we expected.
While it's still early days were extremely pleased with the feedback from both clinicians and consumers, as well as the progress of our early discussions with payers and the effectiveness of our launch preparations and execution today.
Notably the first yes, to go prescription was written within hours of approval.
With the first product shipped within 24 hours, and the first dose administered within days. Well, ahead of our expectations
Prior to launch or any commercial engagement? Yes, To Go's unaided awareness. Among Healthcare Providers was at 72,000 more than twice, the typical pre-launch awareness.
With aided awareness at 95%.
I look forward to sharing more about yes Togo's early performance in the coming quarters.
We are well on our way to achieving our target of 75% access for Yes to go within 6 months of launch and 90% within 12 months.
Outside the US, we have just received a positive chmp opinion and expect a European commission decision on lenacapavir in the next 2 months.
Our launch preparation in our initial Target. European territories are underway.
Gilead is committed to facilitating, access to l cap for those who could benefit from HIV prevention, regardless of where they live.
With that, in mind, we recently announced a partnership with the global fund to bring Lena capir to approximately 2 million people in primarily low and lower middle-income countries over the next 3 years.
We were also pleased that the World Health Organization and the international Aid Society. Both recently announced new HIV, prevention guidelines recommending the use of lenacapavir
With that in mind, we're increasing our full year sales guidance. And now expect HIV sales to grow approximately 3% in, 2025 up from our prior, Assumption of flat Revenue year-over-year,
And Discovery performance so far this year and our expectations for the second half.
Some additional considerations first.
We've made no change to our assumption regarding the impact of Medicare Part. D redesign, which at the start of the year. We expected to impact our HIV business by approximately 900 million in 2025.
Excluding this headwind, HIV growth. This year would be more than 7%.
Second. Given the recency of launch. We have made no changes to launch assumptions surrounding, yes to go.
And finally, given a broad range of possible policy outcomes, our updated HIV guidance assumes no changes to the current landscape.
Moving to liver disease on slide. 12 sales of 795 million were down. 4% year-over-year following a particularly strong second quarter of 2024.
Average realized price and lower patient starts in hcv partially offset by the very strong launch of the deli as well as demand for hdv and hbv products.
For hcv, us pricing has been impacted year-over-year by Medicare Part D. Redesign while volume was driven by the timing of purchases in both the US and internationally.
In primary biliary collinitus. We continue to be pleased with live Dell's performance in the US as well as the early launches in Europe following approval, last quarter.
Overall Revenue, almost doubled from 40 million in the first quarter to 78 million in the second driven by growing second line, PBC market share with our focus on both Market expansion and Persistence of therapy.
Ahead. We are particularly encouraged by the demand we're seeing for live Deli. In new patient starts.
That said and after tremendously strong second quarter, we do expect sequential growth to be more moderate in the third quarter reflecting continued growth in new patients, but a slower uptake among switch patients where Cadence of physician visits remains a gating Factor.
Moving to slide 13 to delvi sales of 364 million were up 14% year-over-year And 24%, sequentially reflecting to a delvies continued strength in metastatic breast cancer and more than offsetting on a year-over-year basis. The expected decline associated with the withdrawal of the bladder cancer, indication in the US.
Internationally, we have seen strong, demand growth, both year-over-year and sequentially, where launch momentum and share gains continue, or cross major markets.
Building on our market leadership. In second line, metastatic triple-negative breast cancer. We're working towards filing for approval in the first line, setting based on the potentially practice-changing results from the ASENTO 3 and ASENTO 4 trials.
As a reminder, there are almost twice as many patients in the first line metastatic setting compared to second line as well as longer duration of therapy. And we look forward to expanding the options available for patients in this earlier line setting.
For cell therapy on slide, 14 and on behalf of Cindy and the kite team.
Second quarter, sales of 485. Million were down 7% year-over-year, primarily driven by lower demand, partially offset by higher average realized price.
As expected, our Kite cell therapies continue to face competitive headwinds. However, sales were up 5% sequentially, helped by a favorable FX impact in addition to higher demand for Yescarta in the U.S. and for Cartas globally.
It's taking time to reduce the barriers to broaden adoption of cell therapy but we're making progress.
For example, the FDA recently removed the CAR-T class requirement for a RAMS program, which we believe will reduce the burden of CAR-T administration for healthcare providers, patients, and caregivers. We're pleased to see these changes starting to be rolled out across authorized treatment centers.
FDA also made additional changes to the carti product labels that will have meaningful impact on patient and caregiver quality of life.
This included a 50% reduction in the time. Patients, need to remain near their treating Center and a 75% reduction in driving restrictions.
We continue to believe that outpatient delivery remains key to broader Cell Therapy adoption.
With that in mind, new real-world data shared at ASCO highlighted the viability of outpatient administration for Yescarta.
This is also reflected in increasing outpatient adoption over time, suggesting growing physician comfort with the use of Escarda in this setting.
Our efforts to educate Physicians and patients on the potential benefits of a 1-time. Carti treatment are also ongoing.
Most recently, we highlighted new 5-year overall, survival analysis, from tecartus, in B cell acute. Lymphoblastic leukemia at eha the longest follow-up of any cartoon therapy in this indication.
Together these new data support. Our goals of bringing Cell Therapy closer to patients and increasing adoption.
Wrapping up our second quarter.
I want to thank the commercial teams for delivering, yet another strong quarter of impact for patients and financial results for Gilead.
Any commercial organization is energized by new product launches, and we are so fortunate to have several new, exciting, and impactful products in our portfolio.
Moment for Gilead. And I know the commercial teams share a sense of both excitement and responsibility given the potential to truly transform the HIV landscape in the coming years.
And so with that I'll hand the call over to dmar.
Thank you, Joanna and good afternoon everyone. I'd like to start on slide 16 by recognizing the years of tireless effort across many research and development teams at Gilead kite and our partners that contributed to a spectacular quarter of clinical results.
In April and May we announced positive Topline results from Ascent 04 and Ascent 03 that showed to delvi regimens demonstrated, highly statistically, significant and clinically meaningful efficacy with a potential to be practice changing in first-line, metastatic triple negative breast cancer.
In May and June, we shared promising early results from our next-generation biases: chronic heart disease and lymphoma and glioblastoma.
In June, we shared updated data from our pivotal, imagine 1 trial in fourth line and later, relapsed and or refractory multiple myeloma. That further reinforced our belief in a needle cell's best-in-class potential.
And also in June, we achieved, FDA approval of yes, to go our breakthrough twice yearly injectable for HIV prevention, which we truly believe has transformative potential.
We Believe Lena Caper will help bring us closer to our goal of ending the HIV epidemic in the years ahead.
You have heard Johannes excitement about the commercial launch in the US and in July, we were pleased chmp adopted positive opinions for our EU marketing authorization application and for EU medicines for all, which enables the streamlined assessment for whoa, pre-qualification and additional Global regulatory reviews.
These are critical advances in our plans to help make Lena capable for people who need to be protected from HIV globally.
this is a moment of Pride for this skill at team and has given me personal pause as I recognize and appreciate the Brilliance of the team of scientists that we have here and the determination to keep out innovating ourselves to achieve the best possible experience and outcomes for those we serve
With that, in mind, our work in HIV continues. As you can see on slide 17 with the approval of. Yes, to go. We continue to Target up to 8 additional HIV product launches before the end of 2033, including 5, that would come to Market by the end of 2030.
In HIV prevention. We have initiated our phase 3 trial evaluating once yearly intramuscular injections of lenacapavir for HIV prevention. Now called purpose, 365, if successful, this could launch as early as 2028,
In HIV treatment, we continue to expect an update on our new daily oral combination of bigger V and lenacapavir in the second half of the Year from Artistry 1 in people with HIV on complex regimens. In addition to Artistry 1, we now expect to provide an update for Artistry 2. The second phase 3 trial for big Glen for virally suppressed people with HIV or people looking to switch regimens.
Looking at our weekly HIV treatment programs. We expect the phase 3 update on the Lena cap are plus is later via combination in 2026 with a view to potential launch in 2027.
As we announced our wholly owned weekly wonders program. Evaluating the combination of GS 4182 1 of our Atlanta, Caper Pro drugs and GS 1720 1 of our long-acting integrates Inhibitors is on clinical, hold pending further analysis, we're making progress on our other oral long-acting candidates, and continue to expect our wholly owned once weekly program to be moving forward with a delay of 3 to 6 quarters.
Among the rest of our leading HIV programs. 3 are in Phase 1. Namely our monthly oral and our quarterly and twice yearly injectables. We look forward to sharing updates on these in due course.
Finally, we continue to plan for our Phase 3 study, evaluating Glenna Caper Plus, broadly neutralizing antibodies or bnAbs as a potential twice-yearly injectable treatment. We continue to target commercial launch in 2030.
To delve this impact in metastatic triple negative breast cancer was reinforced with highly statistically significant and clinically meaningful results in the phase 3 Ascent 03 and Ascent 04 studies in the first line setting.
At ASCO, we presented potentially practice-changing detailed data from ASCENT-04, showing that treatment with Trodelvy plus pembrolizumab resulted in an 11.2% progression-free survival, a 35% improvement versus chemotherapy plus pembrolizumab.
We saw an early trend for improvement in overall survival with Pro. Plus penro though, we would note these data are immature.
Still, these results are remarkable, given the high share of patients, who crossed over to trade, delvi following disease, progression in the control arm, which would be expected to mask a potential overall survival benefit.
We will be filing for full approval, based on the primary median PFS endpoint for both Ascent 03 and Ascent 04 with a potential FDA regulatory decision expected in 2026.
We plan to share detailed phase 3 acento 3 data at an upcoming medical meeting which will allow it to be considered for future guideline updates.
These results are encouraging as we continue to evaluate to delvi in earlier lines of breast cancer, in addition to a scent of 3. And a cent of 4, our other phase 3, breast cancer programs. Include a cent 07 in kimona, Eve hormone receptor positive her2 negative metastatic breast cancer, evaluating to delvi following endocrine and cdk for 6 inhibitor therapies. This is an event-driven trial and we will update you in due course and a cent 05 in high-risk early triple negative breast cancer, evaluating add event, rodel V plus pembro. As would be expected with an earlier line trial in a potentially Curative setting. It will be several years before we are able to provide an update
We also remain focused on clinical execution of our 5, other ongoing phase 3 programs for today, and Don Benelli map across lung endometrial, and upper GI cancers.
Moving to slide 19, and on behalf of Cindy and the kite team. We were pleased to present new data from across our cell therapy pipeline at the ASCO and eha congresses.
In partnership with our celix data, from the Imagine 1 trials.
We continue to believe a needle cell, has the potential to offer a best-in-class profile and we look forward to presenting pivotal data from this trial towards the end of the year. As a reminder, we continue to Target 2026 for a commercial launch.
From our next-generation constructs at ASCO, we presented initial data from the bispecific CD19/CD20 Kite 363 CAR-T, which we believe has shown a promising profile in B cell malignancies. We have selected Kite 363 to be evaluated in Phase 1 trials of autoimmune and neuroinflammatory conditions.
In the second half of this year, we will decide which program to advance in hematology choosing between our 3. Next Generation, CT constructs.
Additionally, in collaboration with the University of Pennsylvania, perilman, School of Medicine ASCO data on the biases tronic. Egfr il13. Ra2, CT, strengthens proof of concept for expanding cartas to treat solid tumors.
Overall, we remain excited about the potential of our next-generation therapies to offer improved efficacy and safety profiles and to reach patients faster. As we work towards our goal of bringing potentially curative therapies to patients,
finally moving to our pipeline milestones and slide 20, we have had an extremely productive and successful quarter overall
Looking to the rest of the year. We expect the pivotal update from our, imagine 1 trial, evaluating a needle, sell in fourth line or later relapsed or refractory multiple myeloma,
The European commission decision on land a capability for prep following the recent positive chmp opinion and the phase 3 update for Artistry 1. Evaluating big Glen in people with HIV on complex regimens
Ally suppress people with HIV.
Together Artistry, 1 and Artistry 2 have the potential to support Global regulatory filings, that could expand the reach of Gilead HIV treatment business with that. I'll turn the call over to Andy
Thank you, dear and good afternoon, everyone.
Starting on slide 22 our second quarter results show continued strength in execution across the company.
Our base business was up 4% year-over-year to 6.9 billion dollars driven by growth in Victoria, D skavi, lived Deli and Trad Deli.
Reflecting fewer Co related, hospitalizations That Glory sales were down 44% year-over-year. Resulting in total product sales of 7.1 billion dollars up 2% year-over-year.
To our non-gaap results on slide 23.
second quarter product, growth margin was up 1% from the same quarter last year to 87% driven, by a more favorable product mix
R&D expenses were up 9% compared to a relatively low second quarter of 2024 reflecting investments in clinical manufacturing and study activities.
I'll highlight that we continue to expect full year R&D expenses to be roughly flat on a dollar basis from 2024 and year to date R&D expenses are tracking in line with our internal expectations.
Acquired IP R&D expenses were 61 million in the second quarter, primarily driven by the Chimera collaboration we announced in June.
Sgna expenses were flat year-over-year with higher sales and marketing expenses, primarily related to our HIV franchise offset by lower GNA expenses.
Second quarter, operating margin was 46% or 47%, excluding acquired IP R&D.
The non-gaap effective tax rate was 19% this quarter in line with our expectations.
And finally, non-gaap diluted EPS was $2.01 for the quarter.
Moving to our full year. Guidance, on slide 24, we had an extremely strong first. Half of 2025 driven by our HIV portfolio and bolstered by the encouraging momentum. In both live Deli and trade elvi.
With that, in mind, we are updating our full year 2025 guidance as follows.
we now expect product sales, excluding veluri of approximately 27.3 billion to 27.7 billion dollars representing an increase of half a billion dollars in our base business, expectations for 2025,
This update reflects HIV growth of approximately 3% year-over-year driven by the outperformance of big tarvey and Discovery year to date.
FX tailwind and softer Cell Therapy expectations. Where we now expect a modest decline for full year 2025 versus full year 2024.
I'll note that our assumptions have not changed in the following areas.
Firstly our assumptions for the impact of Medicare Part. D redesign remain unchanged from the beginning of the year and we expect approximately 1.1 billion dollars of impact to our business.
Secondly, while we're very encouraged by the launch dynamics of. Yes, to go to date. We are not updating our assumptions for yes to go Revenue in the second half of 2025 at this time.
And finally, we have not updated our expectations for the impact of potential tariffs or other changes to the broader policy. Environment, we continue to expect the impact of known tariffs to be manageable in 2025.
Moving to slide 25. We are reducing our full year 2025 expectations for be Glory by million dollars to approximately 1 billion dollars reflecting the current path of the co 19 pandemic, including lower hospitalization rates in the first half, and the trends we've seen in the first month of the third quarter.
As a result, total product sales are expected to be in the range of $28.3 billion to $28.7 billion, with a half a billion dollar increase in base business expectations, partially offset by lower COVID-19 sales.
For other items in the p&l on a non-gaap basis. We now expect
Product, growth margin to be approximately 86%, reflecting strong, performance year to date, and a more favorable product mix.
We expect R&D expenses to be roughly flat on a dollar basis from 2024 which is consistent with our expectations at the start of the year.
In addition to known commitments and expected Milestone payments.
Sgna expenses are now expected to decline by a mid to high single-digit percentage, compared to 2024 updated to reflect higher, HIV sales and marketing expenses and other corporate expenses associated with higher 2025 based business expectations.
Rounding out the p&l. We expect operating income to be between 13 billion and 13.4 billion.
Our effective tax rate to be approximately 19% consistent with our prior guidance.
And we expect our full year. Diluted EPS to be between 7 and 95 and 8.25 an increase of 20 cents at the midpoint compared to our prior guidance.
Looking ahead, we will continue to monitor the macro landscape carefully, and we expect that our disciplined approach to operating expense management positions us well to adapt as needed in the months ahead.
On slide 26.
Our Capital priorities remain unchanged and we return 1.5 billion dollars to shareholders in the second quarter.
This included 527 million of share repurchases, currently being executed under our 2020 plan.
We expect to complete the 2020 program over the next several quarters, and our board recently approved a new 6 billion program to support continued share repurchases.
These repurchases are intended to offset Equity dilution at a minimum, but can also be used opportunistically as you've seen in the first half of 2025.
Overall Gilead delivered, another very strong quarter of clinical and Commercial execution supported by our disciplined operating model.
As we look to the second half of the year, we believe that Gilead is well positioned for near-term and long-term growth, and we remain focused on delivering on our strategic commitments.
With that, I'll invite Rebecca to begin the Q&A.
Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to 1 question so we can get to as many analysts as possible. During today's call again, to ask a question, press star 1 and to withdraw, your question, press star 2.
Our first question comes from Tyler van beer at TD Cowen. Tyler, go ahead. Your line is open.
Great. Hey there. Thanks very much. And congratulations on the progress. I, I know you'll be shocked to hear this question but but can you please elaborate on the early uptake with the s2o and whether you expect the early prescriptions to trend linearly from here, or if it's still very early in what is expected to be a more of an exponential launch curve,
Yeah. Go ahead. Joanna, please. Thanks. Hi. We are very surprised to get that question. Um, Tyler thanks for the question, it's Joanna. Um, yeah, we're really pleased with the launch so far and you're right. It's still early days. We're about 6 weeks in, um, but super thrilled to see what's been going on. I think number 1. A lot of that has to do with the Readiness of the cross functional teams. Um, as you know, the day that we got or the I should say the hour, we got the approval, everything was basically ready to turn key and get going. So the, the the teams have hit the ground running and uh, just really proud to see how they're working together in pods across the US to make sure that this happens we've already had over about 25,000 customer calls, um, executed in the field and just understanding that our, our Target base is about 15,000. So many of those customers have seen, um, either a representative or a medical sales, um, representative more than once and, uh, and
And that's how we, we, we see, kind of the uptake and the excitement. When we think about the awareness at launch, it was already kind of double. What we usually see in Industry at launch, right? You, you were looking at about a 72% unadded awareness, usually those numbers in the 30s or so, um, and then, of course, our aided awareness was 95 plus. So we really knew that as we were going into this, we were ready and now it's up to us to pull it.
Through those those, um, those scripts as quickly as possible. But different plans will take different times and that's what we're we're obviously very conscious of at the same time, I will say we have a couple of early wins that we're really proud of, um, 1. I would say the J Code. Which sometimes is, you know, having a miscellaneous J, code is great, but having the J Code come through, it's actually really important. Just simplifies the whole billing and reimbursement process and we got confirmation that our J code is coming through for October 1st. Um, you probably know from other launches, usually, that takes at least 2 to 3 quarters. And so, that's a little bit ahead of our expectations.
And then we've had some early commercial wins.
Um, we are some plans have come in as of August 1st, and then um, uh, we've had also some State Medicaid wins and namely, I just want to highlight. We have a couple of more than this, but, um, 2 out of the 4 biggest prep States. Um, prevention states are um uh California and Florida and both of those are on formally as of August 1st. So we're really pleased to see that more and more lives are getting access and and working through kind of those medical exceptions as we go and really high interest from a lot of our payers, um, to make sure we can have those discussions. So we've engaged with multiple accounts over 200 accounts we've engaged with to make sure they have all the information they need to make those formula decisions and so that's what we're working through. Um, and
And that's obviously going to take a little bit of time as as, you know. But I think, uh, we're very well on our way to achieve our goals, so super excited. Hopefully, you can hear it and see all the data to the proof points to support it. Um, I think we have the right team, the right attitude and the responsibility to make sure we really make a difference here with yes to go and then the curve of this epidemic. So, uh, stay tuned as uh, as a little bit more data comes through in the next quarter and uh, more to come
Thanks Joe. Thanks, Tyler for the question. I just want to add. I'm really impressed with the teams early launch support here and we look forward to updating you in. Quarters to come. Can we have the next question, please?
Our next question comes from parents Flynn at Morgan Stanley. Go ahead, Karen, your line is open.
Great. Uh, thanks so much for taking the question and congrats on all the progress as well. Um, Joanna, I you mentioned disco we had 1 of its best quarters ever. I think if you look at the the growth trajectory there, it's obviously been very robust and looks to be tracking. Well, above the 8% rate that I think is implied in your, um, longer term guidance, for the prep Market, when you guys look out to 2030. So just wondering how, um, durable this kind of a growth rate is, um, given what you're seeing out there in the market, and a lot of the work you're doing at, uh, you've done ahead of the years to go launch and then just 1 clarification. Can you just comment on the accuracy of yes to go IQ via data? Um, for us, if you have
Any visibility there. Thank you.
Sure, thanks Terrence. Um, so a couple things 1 is the prep Market is growing nicely at about double digit, right about 15% or so year on Year. And that obviously has to do with a lot of the work that we've been. Um, we've been pulling through a lot of initiatives in the field to increase awareness, about prevention, and the importance of prevention. And that's why we were excited to share that. Those numbers are growing quite actively, and we're at about 500,000 or so active users in prep, which is well, on our way to kind of those goals that you were referring to over a million by mid 30s. Um, we do think um, that there's an opportunity for us to um basically continue that growth in the marketplace, especially with the excitement with yes to go. I think the purpose 1 and purpose 2 Data are just so powerful that they're really having impact in the field. So we will continue to drive that
to your comment around discov and um the incredible performance that we've been seeing with disco being right that 35% share a lot of that has to do with um um basically continued favorable access that we've seen over the last um 6 to 9 months or so where we're seeing the co-pays come down to 0.00, in many cases, our access basically jumped up a little bit and we're now at about, you know, if you think about unrestricted restricted access, we're at about 88% of total lives covered, and we are about 98% total covered lives.
Because the intent with yes to go is obviously, um, to look at the total prep market and make sure that we're differentiating their across all the orals, as well as other long-acting. Um, so you will see a little bit of a, a, a shift in the mix, right? As we go forward.
Um, hopefully that addressed that question and your quick comment on IQ via data. Listen, it's still really early, um, but we do believe iqvia data is directionally aligned. Um, it just some accounts, some channels are not represented in iqb as you well know. So they're not reflected in the data. I think we're going to need a couple of more quarters to stabilize as you've seen in the past with other launches, having said that we are so pleased, kind of with what we're seeing in the initial uptake, the customer response. Um, I I think I will tell you the excitement is palpable internally externally. And I would also say that we're also tracking really closely, um, kind of the, the customer uptake as well, right? So as it goes through into the reimbursement because our teams are making sure that we can pull those scripts through. And what really matters through iqvia is um users that are getting the injections so we're tracking both of those really closely. Um so stay tuned but I think a couple more cars will help us kind of
Normalize that data.
Potential um demo projects and things like that with MFM. But we're also tracking um, the current legislation with Medicaid as to the big, beautiful Bill and uh, we are tracking that um, realizing that most of those have implications late 26 into 27. So no immediate impact at this point in time, having said that all of that said HIV is very different and it it is. Um, a disease that obviously if you don't
Coverage and access to the medicines, they need.
Our next question comes from Evan fingerman at CMO Capital markets. Evan, go ahead. Your line is open.
Well, thank you for the question and really congrats on the progress, given the importance of the s2o launch and the recent changes to the HHS preventive, Task Force, if prep is removed. As a preventative, me medicine, broadly. How does this change your approach to commercialization in? The, is there a potential also impact to? Thank you so much.
I heard most of that. Um, it's Joanna, Evan. I I'll take that 1. Um, yeah, so so listen, let me start by saying, um, the, the USPS, um, guidance is something we truly support. We believe in preventive Services, we think it's very important across all the Visas. But namely, in HIV, when you think about prevention, the current guidelines are well, enforced. Um, they support the zero dollar co-pay, um, and uh, without, um, access restrictions or step edits or whatnot, for HIV prevention. And we believe that also includes yet to go, as we're going forward with those conversations with the plans.
As I mentioned earlier, Discovery is well covered, um, 88% of access with no restrictions, um, having said all of that, if there was to be a change in the future, not not that we foresee that. Um, if there was to be change, I just want to remind you that um, these guidelines didn't really have legs until probably less than a year ago. Probably about 2 3 quarters ago. And before that the prevention Market was still growing, very strong, same rates, basically that we're seeing today and we were very successful with Dyco at about a 40% share. Or so, we're now closer to about, um, a little bit towards the 444% share now, um, and the Market's still growing at around the same rate. So we do believe that, um, whether we have USPS,
ETF that's ideal. If it if it was to change in any way we still believe we could work through it and just work closer with our payers to make sure that people have access to HIV prevention. Moving forward, just as they do today.
Our next question comes from Chris shot at JP Morgan. Chris go ahead, your line is open.
All right. Great. Uh, thanks so much and yeah, congrats on the the progress. I just want to ask about the the treatment Pipeline and specifically just elaborate on your confidence on the 4182 1720 that the weekly treatment combo, the Wonders program uh following the clinical hold against earlier this year. I guess just kind of next update so we should be watching for on that combo.
And and just how does that Stack Up relative to some of the other treatment combos that you're working on. Thank you.
Hey, Chris, we'll get deep Mars voice here. Yeah, the, the thanks Chris for the question, um, our confidence in in the treatment pipeline is high, right? And, and remember, we not only work on a, on a weekly, uh, approach. We also work on daily monthly every 3 months and every 6 months approaches. So so the pipeline is deep. We have a variety of different molecules and if you look at 4182 and 1720 1 of them is Alena cap pro drug, the other 1 is an indie and we have several other molecules of those classes um, in our portfolio. So what we're currently doing is we're trying to understand the data further. We're doing pre-clinical and clinical analysis to really isolate uh the observation uh that we had to make sure we we understand which of the molecules led to that observation and then to move forward expeditiously. Uh you know, with 1 of our other molecules that we have in the portfolio, in a new combination to really get that Weekly.
Treatment uh opportunity to patients. Um I also want to mention that. Um we obviously have our phase 3 island program is Led uh is later be and land a cap are ongoing, which is you know currently in Phase 3 the the next update on that program is coming 2026. And the the estimated launch for that 1 is in 27.
Um with regards to our wholly owned program kind of the um 1 this program and the succession of that. Uh we will update you in due course.
Our next question comes from Jeff Meacham. At Citi Bank guests. Go ahead, your line is open.
Market is is 1. That's it's sort of Novel and new for you guys and want to get some context there. Thanks.
Uh thanks Jeff. Um, I do think that you're right. I think there's a broader opportunity with yes to go X us and a lot of that has to do right with Discovery. We were kind of challenged in many markets, the comparator with chat and chat was generic and many of those markets with yes to go. I think with the Innovation the transformational value that we are bringing for markets that truly recognize the need for something else in HIV prevention and recognize the value of Clinic, what it brings to their populations, or their specific Target populations, where you see an HIV incident. That is very high. I really do think there's an opportunity for us, um, to have broader footprint than just where we are today with Discovery, for example. And so I think at, you know, to your point at stable at steady state, or at Peak, I do think, maybe that'll take a little bit of time because I think the Challenge from a reimbursement standpoint will not be, um, simple.
But I do think for the countries that have literally said, um, and did very outspoken that they want to bend the curve or that they're not meeting their 2030 targets, which nobody is. Um, this is really an opportunity for us to partner with those stakeholders and make sure that uh, yes, 2 goes available for those countries.
Our next question comes from Mohit bansal at Wells. Fargo moit, go ahead. Your line is open.
thank you very much and
So, 1 more for you. Uh, so, uh, so the question is, uh, regarding the logistics, uh, as well as the, the safety side of it. So, uh, just wanted to understand for us to go, uh, uh, the logistics dynamic because this is a p. This is a prescribable, uh, base that is used to, uh, orals. And now they're going to use, uh, an injection, which is also a doctor's offices. So how are you navigating that? And, uh, uh, uh, would it take some time to to, to help understand prescribers? Uh, the, the entire Dynamic, uh, would love to understand that.
Thank you.
Sure, sure. Um and and and, you know, as we were preparing for this launch, we were leveraging, a lot of the learnings of past launches, um, in this space or launches, that went from an oral to injectable, um, just to understand what we needed to do to prepare for it, and 1 of the key things with education, um, and making sure that it was optionality flexibility for where they go. So the at launch we were able to offer our customers, um, our hcps, the clinics to make sure that they understood that they could, they could prescribe it and, um, do Biden bill in their office. We also offer them to make sure that if they could
Describe it and then send the script to Specialty. Pharmacy. And they would do all the background work and then send the product back for the injection with the user, the consumer. And, or if they didn't want any of that, they could go to an alternate site of care and basically, just send with the script, um, the the consumer to, to that alternate site of care for their injection, um, and do all the reimbursement back background work. So so I think we've set it up with a lot of flexibility and what we're seeing, although very early, um, what we're seeing is exactly kind of what we thought. We thought at the beginning, we're going to see a lot heavier towards Specialty Pharmacy. A the buying bill would be more the clinics that were already doing buying bill in the past. Um, and a little bit of alternate side of care is happening as well, but few and far between and so. So, I think it's still very early to kind of assess where that's looking for, um, but I will say, 1 of the biggest differentiation is I talked a little bit earlier around cross functional Network and partnership.
The teams are set up across the us so that they have a full cross functional team, whether it comes with nurse Educators field reimbursement, um, the medical, um, representative, the commercial sales representative, and they work together in pods. So what they've done is actually set up meetings with a lot of these clinics around the country together so that they could answer all the questions at the same time to navigate the process the logistics for, yes to go and that has apparently had incredible.
Um, our customers aren't used to that.
And they've been incredibly appreciative and satisfied with what we've been bringing so that they have all their answers, um, when they need it so that they can put pen to paper and prescribed for their patients. And so, I think we're managing it, um, incredibly cross-functionally and making sure that we understand the complexity of the logistics but making sure the customers, see it as simple. And so that's our goal.
Comes from Courtney Breen. At Bernstein Courtney. Go ahead. Your line is open.
Hi well thanks so much for taking my question today. Um probably another 1 for for Joanna. I think um you spoke a little bit about kind of you've been surprised.
positively so far in the Years Togo launched around access and around kind of the connecting of the dots for the team has been able to achieve and, and the scripts and the actual injection rates
Why didn't you raise the the launch expectations or the guidance as you thought about kind of the yes to go launch for the remainder of this year? What are the things that are still question marks in your mind? That would give you confidence to kind of raise your own expectations in terms of this launch for the the early parts and and what we might see this year. Thank you.
Courtney great question and and I think I would answer it with 2 ways 1 is it's still very early, right? We're 6 weeks into the launch. So that's 1. 2 is access is critical here. And so we're managing. You know what offs on medical exceptions every time, you know, our our field reimbursement, um, Team here is that there is a little bit of a block somewhere and we're working through it with the plans, but I think more importantly, we really need to see the number of covered lives increase over the next quarter or 2 to really um, see that momentum and really
Pull through those intake calls, um, into scripts and injections. And so that's kind of the piece that we're waiting to see. And so, I, I think you can ask me that question again in a couple of quarters and, uh, and we'll go from there.
Our last question comes from carter gold at caner. Carter go ahead. Your line is open.
Great, thank you. Uh, good afternoon. Congrats on all the sigo progress, maybe to switch things up. I just wanted to ask on sort of the, your continued confidence on a need to sell approve proability based on a single arm study. A familiar with the feedback your partner receives some time ago. But since then there's been by specific approvals competitor cartas have had confirmatory data coupled with obviously no shortage of disruption across sibur and FDA so just how you get comfortable with the feedback from yours past still applies and if there's been ongoing feedback that bolsters that confidence, thank you.
Yeah, I know we’re not communicating our regulatory strategy other than to say that we are continuing to have conversations with the FDA and are looking forward to launching in 2026. We don’t have any major shifts in the things that we’ve communicated before and are looking forward to filing a new IND.
Thank you.
Great. Uh, this is Dan. I just want to uh, thank everybody for your questions today, for joining the call. Maybe it's just a couple of closing comments from my side, you know, as we've shared today, this has been a really successful second quarter with growth drivers from all 3 of our therapy, careers contributing to the 4% growth in the base business, you know more
Further than offsetting the anticipated headwinds we had from the Medicare Part D redesign just to remind you all were incredibly proud, you know, of and much of the call was devoted to this to deliver the world's first twice yearly prevention for HIV, Atlantic capab. Um, in the US, it's, it's really off to a very strong start. We'll continue to update on the quarters with that. Um, but in addition, of course, we had the positive chmp opinion on. Yes. To go and a great start overall with the launch. So we're incredibly, you know, impressed and proud of of where we believe this will go. And overall, it's also been 1 of our strongest clinical quarters we've ever had, you know, we didn't speak about it so much today, but in addition to that, we had the back-to-back positive phase of results for telby. And we just finished with the last question on the Neo cell and cell therapy and the broader Cell Therapy pipeline. I would say.
And you know, this Top Line performance is transforming down to the bottom line and it's a really special time at Gilead with so many launches imminent, launches, he has to go live Deli to delvi. First line potentially coming up as well as a needle sell, so it's a strong time for the team. So, I just want to take this opportunity to thank the Gilead team for the incredible efforts are putting into driving this level of innovation. I want to thank all of you for joining us today. As usual, our IR team is available for follow-up and any questions that you have, we wish you a great rest of your day and thank you for your interest in Gilead.