GILD (GILD)

“As previously shared, FDA has granted BIC/LEN priority review, and we continue to anticipate a decision by August 27.”

“U.S. launch preparations are currently underway for bictegravir plus lenacapavir, our once-daily single-tablet regimen, where we expect an FDA priority review decision later this month.”

“Later this month, we expect an FDA decision on our once-daily oral treatment combining bictegravir and lenacapavir.”

“Overall, we expect full year non-GAAP EPS between negative $0.65 and negative $0.30.”

“Excluding these transactions, our effective tax rate would be 20%, no change from our February guidance.”

“We now expect full year 2026 effective tax rate to be between 140% and 115%, reflecting the nondeductible acquired IPR&D expenses associated with the Arcellx, Tubulis and Ouro medicines transactions.”

“We continue to expect both R&D and SG&A expenses to increase a mid-single-digit percentage on a dollar basis compared to 2025.”

“We now expect acquired IPR&D of $11.5 billion, reflecting $300 million lower second quarter expenses associated with the accounting treatment of potential future milestones related to the Tubulis acquisition.”

“Included in total product sales, we now expect Veklury sales of approximately $300 million compared to approximately $600 million previously, reflecting lower COVID-19-related hospitalizations.”

“Moving to total product sales. We have raised the lower end of our range and now expect total product sales in the range of $30.1 billion and $30.4 billion.”

“And we now expect cell therapy to decline mid-teens percentage year-over-year.”

“We continue to expect approximately $1 billion for Yeztugo sales for the full year.”

“Within HIV, we now expect full year sales to grow between 9% and 10% year-over-year, up from 8% previously, driven by continued strong growth in Biktarvy for HIV treatment as well as Yeztugo and Descovy for PrEP.”

“We now expect base business sales to grow approximately 6% to 7% year-over-year and range between $29.8 billion and $30.1 billion.”

“For the remainder of the year, we anticipate FDA regulatory decisions for BIC/LEN in virally suppressed people with HIV and anito-cel in fourth line or later relapsed and/or refractory multiple myeloma as well as a Phase III ASCENT-GYN update for Trodelvy in advanced or recurrent endometrial cancer.”

“With its deep and durable efficacy as well as a differentiated safety profile observed in the Phase II iMMagine-1 study, we continue to believe anito-cel has best-in-disease potential, and we look forward to a regulatory decision later this year.”

“Our pipeline now includes a Phase I/II clinical program in platinum-resistant ovarian cancer, and we continue to expect entering registrational development in platinum-resistant ovarian cancer as early as 2027.”

“We anticipate a regulatory decision by February 2, 2027, and look forward to the opportunity to add the first long-acting oral prevention option to our industry-leading portfolio.”

“Preliminary data showed the potential for dosing intervals longer than 4 months with additional data from the higher dose cohorts expected later this year.”

“We expect to initiate new Phase II trials in both the switch and naive populations with the first study evaluating once-weekly oral lenacapavir with oral GS-3242 starting before the end of the year and the second study testing once-weekly oral lenacapavir with oral GS-1720 starting in early 2027.”

“We continue to work towards global regulatory filings as quickly as possible with potential for launch of the first weekly oral in 2027.”

“In 2026 to date, the launches of Trodelvy in first-line metastatic TNBC and Hepcludex in HDV are already underway, and we expect potential launches for BIC/LEN in HIV treatment and anito-cel in multiple myeloma before year-end.”

“We look forward to bringing Hepcludex into the small but deeply underserved patient population, and it is expected to be a modest growth contributor in our liver disease business.”

“We continue to expect robust full year growth for Descovy, driven by pricing favorability as well as demand growth and an expanding U.S. PrEP market.”

“Overall, we continue to be very pleased with the progress of the launch and with second quarter sales of $232 million, up 40% sequentially and continue to target full year 2026 sales of approximately $1 billion.”

“We're also anticipating islatravir plus lenacapavir, the potential first once-weekly single-tablet regimen to launch next year, continuing to build on Gilead's HIV leadership.”

“As people with HIV navigate these changes, we did see a slowing in HIV treatment market growth in the second quarter, although we expect to see this trend back to the typical 2% to 3% rate of annual growth.”

“Given the strong performance in the first half of the year, we now expect full year 2026 HIV sales to grow between 9% and 10% compared to 2025, up from our prior expectation of 8% and driven by continued strong growth in Biktarvy, Yeztugo and Descovy.”

“In the second half, we expect another 2 commercial launches in HIV and oncology while continuing to deliver clinical and commercial excellence across the portfolio.”

“These data are expected to support the filing and potential launch of the first once-weekly oral HIV treatment regimen, islatravir plus lenacapavir in 2027.”

“With a $4 billion annual run rate for our PrEP business and Biktarvy's continued strength, we are raising our full year HIV growth expectations to 9% to 10% year-over-year from prior guidance of 8% growth.”

“We completed enrollment of iMMagine-3 in second-line multiple myeloma this quarter and look forward to potentially filing in this indication as early as 2027.”

“We expect to provide an update in 2027 with potential to launch in 2028.”

“We view this as a differentiated opportunity for a subset of the virally suppressed population and with potential for launch around 2030, it could establish an important early presence in the twice yearly treatment market ahead of our INSTI-based regimen currently in development.”

“We look forward to potentially expanding Livdelzi's leadership in the second-line PBC population as early as next year.”

“We feel very confident in Trodelvy’s overall profile—the data are practice-changing, as recognized at ASCO and ESMO when both studies were presented—and we are excited about the potential approvals of both first line and second line toward the later Q3 of this year.”

“We expect a regulatory decision based on priority review in August.”

“We are targeting a potential launch in late August for people with virally suppressed HIV, including those on complex regimens.”

“This is now under priority review, and we expect an FDA decision in August.”

“We expect an FDA regulatory decision for bulevirtide as a treatment for chronic HDV infection later this quarter.”

“This trial is recruiting ahead of expectations, with enrollment completion expected in the second quarter.”

“We continue to target updates from the Phase 3 ILLAND-1 and -2 trials, in collaboration with Merck, later this quarter.”

“Additionally, we expect a regulatory decision and potential U.S. launch of Hepcludex for chronic hepatitis delta virus infection later this quarter.”

“Other upcoming HIV milestones include Phase 3 updates later this quarter from the ILLAND-1 and -2 studies evaluating a potential first once-weekly oral for virally suppressed people with HIV.”

“We are pleased to note that, excluding these transaction-related costs, we are effectively maintaining our start-of-the-year non-GAAP EPS guidance, highlighting the flexibility in our operating model and our agility as we flex to accommodate the needs of the business.”

“As a result, we are increasing our revenue ranges by $400 million.”

“Given the outperformance of Yes2Go in the first quarter and our growing confidence in the trends we are seeing, we are increasing our 2026 Yes2Go guidance to $1 billion, potentially achieving blockbuster status in its first full year.”

“We expect to have a majority of our authorized treatment centers activated within 2027 based on their enthusiasm.”

“We do expect Yes2Go’s persistency to keep growing over time and to be the highest in the overall HIV prevention market.”

“Given a late August approval, access will need to ramp, so revenues in 2026 will be modest, with a nice ramp in 2027 and beyond.”

“You should still expect very strong financial performance—top line and bottom line. There is room to strengthen the margin over time.”

“We expect in 2027 to find room in our portfolio and P&L as well.”

“Looking ahead, given the pace of our activity in 2026, our business development focus in the near term will be closing and successfully integrating these programs, and maintaining strong clinical momentum.”

“Excluding this impact, our non-GAAP diluted EPS would be $8.45 to $8.85, or in line with the non-GAAP EPS guidance we shared back in February.”

“On slide 25, you can see that we now expect full-year 2026 non-GAAP loss per share in the range of $1.05 to $0.65 per share.”

“Excluding the $11.5 billion in upfront payments related to these recent transactions, operating income would be between $14.0 billion and $14.5 billion, or $200 million higher than our February guidance.”

“Full-year 2026 effective tax rate is expected to be between 140% and 190% reflecting the nondeductible expenses from the Arcellx, Oral Medicines, and Tubulis transactions.”

“And we expect full-year 2026 operating income of $2.4 billion to $2.9 billion.”

“We expect SG&A expenses to remain in line with our February guidance of a mid-single-digit percentage increase compared to 2025.”

“We expect acquired IPR&D investments of approximately $11.8 billion for the year, which includes the upfront payments associated with our recently announced acquisitions.”

“Overall, we expect R&D expense as a percentage of total product sales to be less than 20% in 2026.”

“Specifically, we expect R&D expenses to increase a mid-single-digit percentage from 2025, slightly higher than the low-single-digit percentage increase shared in our February guidance.”

“Our full-year Veklury guidance remains unchanged at approximately $600 million, contributing to expected 2026 total product sales between $30.0 billion and $30.4 billion, an increase of $400 million.”

“This increase of $400 million results in 5% to 6% year-over-year growth, up from the 4% to 5% growth expectation we shared in February.”

“As a result, we are increasing our 2026 base business guidance and now expect a range between $29.4 billion and $29.8 billion.”

“Within HIV, we now expect Yes2Go sales of approximately $1 billion, up from $800 million at the start of the year.”

“Reflecting strength across our HIV businesses, we now expect 2026 HIV sales to grow 8% year-over-year, ahead of our prior guidance of 6% growth.”

“For R&D, we expect a transaction-related modest and manageable dollar increase compared to our start-of-the-year guidance.”

“Additionally, we expect FDA regulatory decisions for Biclen in August and anitocel in December, as well as Phase 3 updates for ILLAND-1 and -2 in the first half of this year, and for EVOQUE-3, ASCENT GYN, and IDEAL in the second half.”

“We are targeting Phase 3 registrational trials in select autoimmune diseases as early as 2027.”

“In the immediate future, we look forward to more mature Phase 1 data on TUB-40 in ovarian cancer at this year's ASCO meeting in June, and expect to enter registrational Phase 3 studies for platinum-resistant ovarian cancer in 2027.”

“Further, we continue to expect Phase 3 updates from EVOQUE-3 in first-line PD-L1–high non-small cell lung cancer, and ASCENT GYN in second line-plus metastatic endometrial cancer, in the second half of this year.”

“We continue to expect regulatory decisions from FDA in first-line metastatic TNBC in 2026, and we now also anticipate European Commission decisions later this year.”

“We expect these data, along with the unprecedented efficacy and safety results from PURPOSE-1 and -2, to form the basis of regulatory submission, with target U.S. approval in 2028.”

“Moving to even longer-acting options, we are excited to be initiating a Phase 2 trial combining our investigational integrase inhibitor, GS-3242, with lenacapavir in the second half of this year.”

“As we wrap up the first quarter and look forward to up to four additional launches this year, shown on slide 14, I want to recognize our commercialization teams for their exceptional execution in driving another strong quarter in Q1, and thank them for their commitment to growing patient impact in the second quarter and beyond.”

“With a late December PDUFA date and factoring in the time needed for site activation, we expect revenue from anitocel to begin in early 2027.”

“Reinforces the strength of the data in first line and a potential launch in the U.S. in 2026.”

“This is inclusive of headwinds of approximately 2% associated with the drug pricing agreement with the U.S. government to lower Medicaid pricing for some of our products and proposed changes to the Affordable Care Act.”

“Reflecting this increase to our Yes2Go guidance, in addition to first quarter strength across HIV, we are now expecting 2026 total HIV sales including both treatment and prevention to grow approximately 8% year-over-year compared to the 6% previously shared in our February guidance.”

“Both Yes2Go and Descovy for PrEP sales are expected to meaningfully grow in 2026.”

“We believe we have the most compelling portfolio of PrEP products on the market and expect to retain and grow our leadership in the rapidly expanding PrEP market in both the near and long term.”

“We are expecting an update from our Phase 3 IDEAL study for Libdelzi in the second half of this year.”

“Additionally, we are expecting a regulatory decision on anitocel, our potential best-in-disease BCMA CAR T, in December.”

“We are also expecting Phase 3 updates from the EVOQUE-3 trial in first-line metastatic non-small cell lung cancer and the ASCENT GYN trial in second line-plus metastatic endometrial cancer in the second half of this year.”

“We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in the second half of this year.”

“Later this year, we plan to share additional data that support the combination of GS-3242 with lenacapavir as a potential twice-yearly injectable treatment regimen.”

“Gilead Sciences, Inc.'s HIV business is poised for strong, durable growth supported by up to seven potential new HIV product launches by 2033.”

“It is less likely that we will pursue more sizable M&A this year, although we will always leave the door open to consider strategic acquisitions if a compelling opportunity emerges.”

“If positive, the IDEAL study could support a label update and expand the second-line PBC addressable population.”

“We expect this DTC campaign to broaden awareness of YES2GO and contribute to a consistent build in YES2GO sales in the coming quarters.”

“On slide 31, we returned $5.9 billion to shareholders in 2025, we remain committed to returning on average, at least 50% of our free cash flow to shareholders.”

“However, in 2027, we will have a full year of sales.”

“We believe Descovy will continue to grow through 2026 and over time, of course, that will erode as YES2GO takes a leading share in HIV prevention.”

“Having said that, in 2026, we believe that Descovy continues to grow through in 2026”

“So we do expect as we come into 2026, we have strong growth momentum already. So Q1 will be we'll start with modest growth and then kind of build on that quarter after quarter”

“In cell therapy, we expect full-year 2026 revenues to decline approximately 10% compared to 2025, reflecting continued competitive headwinds related to our Kite portfolio.”

“As Johanna mentioned, and as shown on slide 30, we expect an approximate 2% headwind to growth in 2026 primarily associated with the impact of the drug pricing agreement announced in December 2025 and the expected impact of updates to the Affordable Care Act.”

“We expect full-year 2026 non-GAAP operating income of between $13.8 billion and $14.3 billion a tax rate of approximately 20%, and non-GAAP diluted EPS in the range of $8.45 and $8.85 per share.”

“And SG&A expenses to increase by a mid-single-digit percentage relative to 2025, reflecting higher investments in sales and marketing to support our commercial launches, offset in part by lower G&A expenses.”

“Moving to the non-GAAP P&L for the full year 2026, we expect product gross margin of approximately 87%, R&D expenses to increase a low single-digit percentage from 2025, acquired IPR&D investments of approximately $300 million reflecting known commitments associated with prior collaborations and partnerships.”

“We expect total Vecluri sales of approximately $600 million highlighting a $300 million headwind that we expect to more than offset in our base business.”

“Based on these exciting data, we are energized to potentially bring Anidocel to patients in the second half of this year.”

“Notably, we expect updates from two of the Phase III trials this year, including ASCENT GYN-01, evaluating Trodelvy in second-line metastatic endometrial cancer in the second half of this year, as well as EVOQUE-03, exploring Trodelvy plus pembro, in first-line metastatic PD-L1 high non-small cell lung cancer.”

“We expect FDA decisions for Trodelvy in first-line metastatic TNBC patients who are not candidates for PD-1 inhibitors, and for Trodelvy plus pembrolizumab in first-line PD-L1 positive metastatic TNBC in 2026.”

“Later this year, we expect to provide an update from our Phase III IDEAL study evaluating Libdelzi in patients with ALP levels between 1 and 1.67 times the upper limit of normal.”

“Looking at our long-acting programs, we plan to share Phase III updates from our ILN-One and ILN-Two trials, evaluating islatrovir plus lenacapavir in 2026 and for our twice-yearly treatment program, we plan to initiate our Phase III trial evaluating lenacapavir plus broadly neutralizing antibodies in the second half of the year.”

“We expect to share detailed results from our positive Phase III trials at the CROI meeting in February with a potential FDA decision by the end of the year.”

“Looking to the second half of the year, the team is preparing for the potential launch of Anidocel in fourth-line and later relapsed or refractory multiple myeloma.”

“Overall, we expect Kite revenue to decline approximately 10% in 2026 compared to 2025.”

“For 2026, we continue to expect these competitive headwinds including in several countries outside the US, where we expect new entrants this year.”

“As the leading regimen in second-line, Trodelvy is already well established with oncologists, and these updates build momentum for Trodelvy ahead of potential first-line launches expected later this year.”

“Absent these headwinds, our HIV business is expected to grow 8% in 2026, highlighting the underlying strength of our HIV business.”

“In total, these headwinds are expected to impact HIV growth by about 2% in 2026 compared to 2025.”

“Our goal this year is to continue to drive rapid adoption of HIV prevention, and we expect both brands to demonstrate robust growth in 2026.”

“We have up to 10 ongoing and potential new launches through 2027 and the strongest pipeline in our almost forty-year history.”

“And on the heels of libdalzi in 2024, and YES2GO in 2025, we are targeting four commercial launches this year.”

“With its unique potential to bend the curve of the HIV epidemic, YES2GO is a transformative medicine that we expect to drive durable, steady, and long-term growth in our HIV prevention business in the coming quarters and years.”

“And Brian, would just remind what we've already stated, which is this could be available as early as 2028. The trial is recruiting well.”

“So we're very confident to -- that we're on track to reach those numbers.”

“I would assume about a 14% to 15% growth continuing with PrEP.”

“So we do expect full year Yeztugo sales of around $150 million or so, including the $54 million year-to-date.”

“These repurchases are intended to offset equity dilution at a minimum, but can also be used opportunistically as you've seen in the first 3 quarters of 2025.”

“GAAP EPS is expected to be in the range of $6.65 to $6.85.”

“And finally, we expect non-GAAP EPS in the range of $8.05 and $8.25, raising non-GAAP EPS by $0.10 at the low end of the range.”

“We continue to expect our effective tax rate to be approximately 19%.”

“we expect operating income to be between $13.1 billion and $13.4 billion, reflecting an increase of $100 million at the low end of the prior guidance range.”

“We now expect full year acquired IPR&D to be $900 million.”

“Similar to last year, we expect a step-up in both R&D and SG&A expenses in the fourth quarter, reflecting normal end of year trends.”

“We continue to expect product gross margin of approximately 86%, R&D expenses to be roughly flat on a dollar basis from 2024 and SG&A expenses to decline by a mid- to high single-digit percentage compared to 2024.”

“Finally, we continue to expect the impact of known tariffs to be manageable in 2025.”

“As a result, total product sales are anticipated to be in the range of $28.4 billion to $28.7 billion.”

“For Veklury, we continue to expect full year revenue of approximately $1 billion.”

“we now forecast approximately a 10% decline for full year 2025 versus full year 2024.”

“we continue to expect approximately $900 million of impact to our HIV business in 2025.”

“Driven by the outperformance of both Biktarvy and Descovy year-to-date, we now anticipate our HIV franchise will grow approximately 5% year-over-year versus our prior guidance of 3%.”

“We now expect total product sales, excluding Veklury, to be between $27.4 billion and $27.7 billion, primarily reflecting higher HIV growth.”

“Year-to-date 2025 R&D expenses were $4.1 billion, in line with 2024, suggesting we are on track for our full year goal.”

“pivotal Phase II initiation of KITE-753 for third-line large B-cell lymphoma in the first quarter of 2026.”

“a Phase I study in neuroinflammatory conditions is expected to start in the first quarter of 2026.”

“Finally, we now also expect ASCENT-07 data in the fourth quarter.”

“we remain on track to provide updates for our Phase III ARTISTRY-1 and ARTISTRY-2 trials for BIC/LEN and for our pivotal Phase II iMMagine-1 trial for anito-cel in the fourth quarter.”

“We now expect to provide an update from this trial before the end of the year.”

“we continue to expect an update from our Phase III ARTISTRY studies later this year.”

“We anticipate these headwinds to continue in the near future.”

“Consistent with our performance year-to-date, we are increasing our guidance for full year HIV revenue growth to approximately 5%, up from 3% last quarter.”

“We look forward to sharing progress on one of our next-generation HIV treatments before the end of the year with an update on the ARTISTRY-1 and ARTISTRY-2 studies.”

“As a reflection of our strong performance year-to-date, we are increasing our full year HIV revenue growth expectations to approximately 5%.”

“we would look for those late-stage derisked assets every 2 to 3 years at a minimum to kind of add them to our portfolio.”

“So we do believe it's going to be a gradual ramp-up. And then for us, it really sets up the platform for the ramp for Yeztugo in 2026.”

“We continue to expect an update from the event-driven STAR-221 trial in 2026.”

“we have submitted two supplemental biologics license applications for Trodelvy in first-line metastatic TNBC and expect regulatory decisions in 2026.”

“We're excited by the potential to bring bulevirtide to HDV patients in the U.S. with a potential regulatory decision in 2026.”

“we expect to share more details on GS-3242 at a Virology Conference in 2026.”

“this is expected to support a regulatory filing with potential for approval in 2028.”

“the benefits of this access will pull through in 2026.”

“We have submitted sBLAs with the FDA and are targeting a potential commercial launch in 2026 that could extend Trodelvy's leadership in breast cancer.”

“we expect to bring it to patients in the U.S. in 2026.”

“we continue to target a product launch in early 2027.”

“as the market grows and continues to grow and the awareness of Yeztugo increases, we also believe that the naive patient population will also grow with time as well.”

“What I would suggest, though, is that Yeztugo gets traction and ramps up over the next coming quarters, you will probably see a little bit of a decline because the intent with Yeztugo is obviously to look at the total PrEP market and make sure that we're differentiating there across all the orals as well as other long-acting.”

“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.”

“And we expect our full year diluted EPS to be between $7.95 and $8.25, an increase of $0.20 at the midpoint compared to our prior guidance.”

“Our effective tax rate to be approximately 19%, consistent with our prior guidance.”

“Rounding out the P&L, we expect operating income to be between $13 billion and $13.4 billion.”

“SG&A 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 base business expectations.”

“And we expect acquired IPR&D to be approximately $400 million, reflecting $315 million of expenses so far this year, in addition to known commitments and expected milestone payments.”

“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.”

“For other items in the P&L, on a non-GAAP basis, we now expect product gross margin to be approximately 86%, reflecting strong performance year-to-date and a more favorable product mix.”

“As a result, total product sales is expected to be in the range of $28.3 billion to $28.7 billion with $0.5 billion increase in base business expectations, partially offset by lower COVID-19 related sales.”

“We are reducing our full year 2025 expectations for Veklury by $400 million to approximately $1 billion, reflecting the current path of the COVID-19 pandemic, including lower hospitalization rates in the first half and the trends we've seen in the first month of the third quarter.”

“We continue to expect the impact of known tariffs to be manageable in 2025.”

“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 of impact to our business.”

“That said, and after a 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.”

“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.”

“We are well on our way to achieving our target of 75% access for Yeztugo within 6 months of launch and 90% within 12 months.”

“In cell therapy, we expect to provide a pivotal update from the Phase II iMMagine-1 trial evaluating anito-cel for multiple myeloma later this year.”

“As a result, we are increasing our revenue and EPS guidance for the full year.”

“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.”

“As a reminder, we continue to target 2026 for a commercial launch.”

“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 continue to target commercial launch in 2030.”

“We are 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.”

“Looking at our weekly HIV treatment programs, we expect the Phase III update on the lenacapavir plus islatravir combination in 2026 with a view to potential launch in 2027.”

“As you can see on Slide 17, with the approval of Yeztugo, we continue to target up to eight additional HIV product launches before the end of 2033, including five that would come to market by the end of 2030.”

“If successful, this could launch as early as 2028.”

“But I just wanna be clear that to date, we haven't heard or seen anything that would cause us to alter our plans or expectations for the LEN for PrEP launch or adversely affect our HIV business.”

“In terms of volume, given the number of safety nets that I was just referring to earlier, there's so many programs that are available today that exist for HIV. We're not expecting to see a material uptick from the Part D reform.”

“And coverage right now is in line with our expectations, so we're at about just over 80% or so coverage with commercial plans, and we think that's going to keep growing probably within the next couple of months. To just well above 90.”

“USPSTF would be nice to have, to be honest with you, but in the first six to twelve months, we're assuming that that's not gonna be in play, and we our plans are really based on our value proposition of lenacapavir.”

“We continue to expect about that $1.1 billion that we shared for total impact of which about $900 million or so is specific to HIV.”

“we've not experienced any impact to our LEN for PrEP filing or any of our clinical trials actually to date. Right? And we continue to expect the lenacapavir decision by June 19.”

“We think about 75% or so access within the first six months. To a peak covered lives at about 90%. At a twelve-month mark,”

“diluted EPS to be between $7.70 to $8.10 for the full year.”

“effective tax rate to be approximately 19%,”

“operating income to be between $12.7 to $13.2 billion,”

“SG&A expenses to decline by a high single-digit percentage compared to 2024,”

“acquired IPR&D to be approximately $400 million, including the $253 million of expenses in the first quarter, as well as known commitments and expected milestone payments.”

“R&D expenses to be roughly flat from 2024,”

“We continue to expect product gross margin to range between 85% to 86%,”

“we do not expect to update our Veclury guidance until our third-quarter earnings call.”

“Veclury sales of approximately $1.4 billion.”

“2025 HIV sales to be approximately flat compared to 2024, with demand-driven growth offset by the impact of the Medicare Part D redesign.”

“product sales excluding Veclury of approximately $26.8 to $27.2 billion,”

“For 2025, therefore, we continue to expect total product sales of approximately $28.2 to $28.6 billion,”

“these could increase some of our indirect costs, but are expected to be manageable in 2025, in part due to potentially lighter FX headwinds than previously expected.”

“we remain on track to provide an update of the data from our phase two one-dose one trial, our wholly owned once-weekly INSTI containing oral treatment for HIV, at an upcoming medical meeting.”

“For anetocel, our pivotal IMagine I study in fourth-line plus relapsed or refractory multiple myeloma is ongoing. And we look forward to providing an update in 2025.”

“we continue to expect a regulatory decision by June 19.”

“Notwithstanding the ongoing competitive headwinds, that we continue to expect to extend through 2025, we remain very excited about the overall opportunity and future for cell therapy.”

“Despite the variability of the path of the pandemic, we expect Veclury's important role to continue.”

“We have just launched in Germany a few weeks ago, and we expect to expand into other major European markets in the coming months.”

“In the meantime, we continue to expect robust demand-led volume growth for the full year. Though, as shared back in February, this will be obscured this year due to Part D headwinds resulting in flat reported HIV sales overall for 2025, with a return to growth in 2026.”

“We continue to expect an update later this quarter on the phase three ASCENT-03 study evaluating Trodelvy monotherapy in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-1 inhibitors.”

“We remain on track for the June 19 PDUFA date with the potential launch in the US immediately following.”

“I think you're gonna see a bit of an acceleration as you think about the lenacapavir launch around the corner.”

“In addition to the ongoing launch of Libdelzi, and the potential launch of lenacapavir for PrEP in 2025, we are also looking forward to the potential launch of anetocel in multiple myeloma and Trodelvy in first-line metastatic triple-negative breast cancer in 2026.”

“we plan to provide an update on our registrational phase two IMagineOne trial later this year and remain on track to potentially launch anetocel in late-line relapsed refractory multiple myeloma in 2026.”

“As a reminder, this is one of up to nine potential HIV products we are targeting before the end of 2033, building on Gilead Sciences, Inc.'s decades of leadership in HIV innovation.”

“So we think Livdelzi's trajectory is incredibly strong and we believe 2025 is going to be where it really comes through from a momentum standpoint.”

“For 2025, we announced today a 2.6% increase in our quarterly cash dividend to $0.79 per share, and we remain committed to growing our dividend over time.”

“Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis.”

“In 2025, while volume and demand growth will continue, we can expect to see a temporary masking of the trend with the anticipated impact of Medicare Part D reform on revenue growth.”

“So the last thing I'll say to your question is that we have said we are targeting -- holding our expenses relatively flat for the foreseeable future and letting the leverage in our model drop to the bottom line and that has not changed.”

“We have no major loss of exclusivity until late 2033, and we have significant potential across the entire portfolio.”

“So we do think that is something that will carry through for the launch of lenacapavir and could actually accelerate it as well.”

“These trials could provide Trodelvy the opportunity to advance into the first line setting for metastatic triple negative breast cancer as early as 2026.”

“we are on track to file before the end of this year.”

“Based on our financial results year-to-date, we are increasing our 2024 guidance across almost every metric, including revenue and non-GAAP gross margin, operating income, and EPS.”

“On a GAAP basis, EPS is expected to be $0.05 to $0.25.”

“Altogether, we've raised our earnings per share guidance to a range of $4.25 and $4.45.”

“Full-year tax is expected to be approximately 27%, slightly lower than our prior 30% guidance, and reflecting the higher operating income for the full year as well as the negative impact from the one-time charge for the acquisition of CymaBay in the first quarter.”

“Reflecting these updates, we now expect operating income in the range of $8 billion to $8.3 billion, up from $7.2 billion to $7.6 billion previously.”

“We now expect R&D expense to decline a low single-digit percentage as compared to our prior outlook of low-to-mid single-digit growth, reflecting the discontinuation of certain programs and careful expense management.”

“Turning to the rest of the P&L on a non-GAAP basis, we expect product gross margin to be approximately 86%, narrowed from our prior 85% to 86% range, and reflecting year-to-date results as well as our expectations for a more favorable product mix in the fourth quarter.”

“We therefore expect full-year 2024 total product sales in the range of $27.8 billion to $28.1 billion, an increase of $650 million at the midpoint compared to the prior range.”

“We expect full-year Veklury revenue to be approximately $1.8 billion.”

“This guidance implies that fourth-quarter HIV could be roughly flat, which we believe is prudent given the strength in the third quarter and the normal variability we can see with HIV pricing.”

“The increased revenue guidance also reflects higher full-year expectations for HIV, now expected to grow approximately 5% from 2023, compared to our prior expectations of 4%.”

“We are increasing our guidance for product sales, excluding Veklury, by $150 million at the midpoint from the prior range to a new range of $26 billion to $26.3 billion.”

“While there will always be some quarterly variability, recent results demonstrate a consistent trend of our operating margin firmly in the 40% plus range, and we remain focused on being an industry leader in terms of operating margin.”

“Recently, we completed enrollment of the Phase 3, ARTISTRY-1 trial within nine months of FPI and are on track to complete enrollment in ARTISTRY-2 by early 2025.”

“We continue to target regulatory submission before the end of the year in the U.S., while at the same time preparing for filings with other global regulatory authorities.”

“As a result, we're raising our full-year guidance for Veklury to approximately $1.8 billion.”

“We expect to start building momentum as we enter 2025, when we look to a more meaningful sales contribution.”

“To that end, for the fourth quarter in particular, we expect HIV sales to be roughly flat, quarter-over-quarter, with continued demand growth and modest seasonal inventory builds, offset by the third quarter pricing dynamics discussed earlier that are not expected to repeat.”

“With that outperformance in mind, we're increasing our full-year HIV growth expectation to 5%”

“Demand in the third quarter was ahead of our internal expectations, and we expect to see growing momentum into 2025 and beyond.”

“Gilead is well-positioned to maintain its leadership in the HIV treatment market with four new regimens by the end of 2030.”

“So could it be beyond the 600,000? Absolutely, 600,000. And we do think that most of that is going to be driven by a new option on the market, and that is Lenacapivir for prevention.”

“So we do believe that it's at least 600,000 by 2030.”

“With that in mind, it is possible we will not reach data cutoff this year, and we look forward to updating you in due course.”

“The remaining transition tax payment of $1.3 billion is scheduled for April of 2025.”

“we are increasing our operating income guidance to $7.2 billion to $7.6 billion, and increasing our non-GAAP diluted EPS guidance to $3.60 to $3.90.”

“Additionally, we are on-track to initiate our Phase 3 ISLEND-1 and ISLEND-2 trials evaluating once-weekly lenacapavir in combination with Merck's islatravir.”

“Looking to the full year, we remain on-track to deliver HIV sales growth of approximately 4%.”

“So, I think that sets us up nicely and ASCENT-03 as we update the status of that trial as the end of the year rolls around I think will be part of the continuation of that story and our expectation for trodelvy's success in triple negative breast cancer.”

“But despite all this, as you heard earlier from both Dan and Johanna, we are facing, it's a dynamic market. We're remaining cautious for the second half of this year as we continue to see some competitive headwinds both in cost competition.”

“For acquired IPR&D, we now expect full-year expenses of $4.7 billion, up from $4.4 billion last quarter to reflect a $320 million transaction with Janssen to buy out the global seladelpar royalty.”

“For SG&A, there is no change to our prior guidance pointing to a mid-single digit decline compared to 2023.”

“For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024, despite absorbing the late-stage seladelpar program.”

“Moving to the non-GAAP guidance, there is no change to our non-GAAP gross margin range of 85% to 86%.”

“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.”

“we continue to expect total product sales in the range of $27.1 billion to $27.5 billion, and total product sales, excluding Veklury, in the range of $25.8 billion to $26.2 billion.”

“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.”

“we anticipate the turnaround time for anito-cel to be on par with Kite's commercially available products.”

“As you know, we expect an FDA regulatory decision shortly, with a decision from European regulators to follow in early 2025.”

“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.”

“This regimen is expected to be the first once-weekly oral treatment option.”

“Initiation of the Phase 2 trial evaluating the combination of these agents as a once-weekly oral regimen is expected later this year.”

“As a result, we expect to provide an update in late 2024 or early 2025.”

“and expect impact from these initiatives towards the end of 2024.”

“We are preparing for potential launch as early as late 2025.”

“we are preparing to support the Phase 3 iMMagine-3 trial from the site starting later this year.”

“We expect an update for PURPOSE 2 late this year or early next year, with a commercial launch as early as late 2025.”

“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.”

“one-third of sales remains our target with the portfolio that we have today and what we believe is achievable without additional BD.”

“finally, there is a possibility of incremental FX headwinds in the second half of the year.”

“there is some uncertainty associated with Trodelvy bladder revenue following TROPiCS-04.”

“Yes. No, we feel very confident that we're going to return to growth in the second half of the year, as we stated.”

“So we do expect broadly for our operating margin to improve over time as you see the continued top line growth and the disciplined expense management.”

“Having said that, overall, we expect our total business to grow despite the impact of the Part D we designed in 2025 with the top line, building momentum in 2020 -- beyond 2025, right, '26 and beyond.”

“While we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizeable M&A transactions in the near-term.”

“On a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate CymaBay expenses.”

“We continue to expect SG&A expenses to decline a mid-single digit percentage relative to 2023.”

“There is no change to our gross margin guidance where we continue to expect product gross margin in the range of 85% to 86%.”

“As discussed last quarter, we do not expect to update our Veklury guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infections.”

“Additionally, there is no change to our Veklury guidance of approximately $1.3 billion for the full year.”

“We continue to expect total product sales in the range of $27.1 to $27.5 billion; and we continue to expect total product sales, excluding Veklury, in the range of $25.8 to $26.2 billion, representing growth of 4% to 6% for our base business year-over-year.”

“On anito-cel in later-line multiple myeloma, we expect to provide a Phase III iMMagine-1 trial update in the second half of this year.”

“In TNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the Phase III ASCENT-03 trial in first-line PD-L1 negative patients later this year.”

“Depending on the timing of event accruals, we anticipate 2 more Phase III updates this year for Trodelvy.”

“We plan on providing updates from Cohorts C and D, evaluating Trodelvy plus pembro and chemotherapy in PD-L1 all-comers at a medical congress in the second half of this year.”

“Moving to PrEP, we plan to share an update from our Phase III PURPOSE-1 trial in the second half of this year.”

“we intend to share data from the Phase III study in the second half of this year.”

“We expect to complete enrollment in the first half of 2025.”

“We expect to start seeing the Impact from this initiative towards the end of 2024.”

“We continue to expect approximately 4% HIV sales growth for 2024.”

“And as we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be breakeven to earnings in 2025, and significantly accretive in 2026 onwards.”

“This is a solid setup as we look to potentially launch lenacapavir as early as late next year as the first and only twice yearly subcutaneous prevention option.”

“So maybe the last thing I'd say is that when we look at the business, this is a business that we have line of sight to biologics margins and profitability.”

“For 2024, we announced today a 2.7% increase in our quarterly cash dividend to $0.77 per share and we remain committed to growing our dividend over time, in-line with earnings growth.”

“Importantly, HIV volumes were in line with our expectations and we are confident in our full-year revenue growth expectations for HIV in 2024.”

“And I can share that we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.”

“Finally, we will continue to utilize share repurchases to offset equity dilution, as well as additional repurchases on an opportunistic basis.”

“Along with PURPOSE-2, expected in late 2024 or early 2025, PURPOSE-1 forms the basis of our potential regulatory filing.”

“For now, given these findings, we currently do not plan changes to our Phase 3 EVOKE-03 study that is enrolling as expected.”

“While we continue to expect the rate of HCV new starts to trend downwards over time, given the curative nature of our medicines, demand growth in both HDV and HBV is largely offsetting that headwind.”

“Starting with Oncology, we expect at least 12 further updates by the end of 2024.”

“We continue to have additional trials that we'll read out this year in Phase 3, specifically the [TROPHY-U-04] (ph) study that we'll be looking at the bladder cancer confirmation study with hopefully an OS signal.”

“Additionally, we remain on track to initiate our Phase 2 PALEKONA trial evaluating our potential first in class 222 inhibitor for ulcerative colitis later this year.”

“Lenacapavir will have a rich year of data on the treatment combination candidates, and we continue to target being first to market with our six month long acting PrEPs, starting with readouts next year on our Phase 3 trials and a commercial launch as early as late 2025.”

“So we'll follow the science, but all of the areas will receive additional capital over time.”

“And the final thing I'd say is you're already seeing the benefits of those investments and the commercial performance that we've talked about for the last two years. So we expect that you will continue to see those benefits in our commercial performance across the entire business, and you're going to see a moderation of expense growth.”

“So we plan to launch that out of our facilities at Kite and expect to have a strong launch again.”

“And in fact, this year we should end with somewhere around 140 treatment centers in the U.S., and that will continue to grow in 2024.”

“And I think you should expect that not only for the next quarter, but then as we go into 2024.”

“and you should expect to see kind of the same play from Q3 into Q4.”

“Given certain one- time tax benefits in 2023, we now expect our non-GAAP effective tax rate to be approximately 16% for the full year.”

“Non-GAAP operating income is expected to be $10.5 billion to $10.8 billion as compared to $10.4 billion to $10.9 billion previously, driven by higher R&D expenses offset by higher product sales.”

“Excluding this, we continue to expect non-GAAP SG&A expense for 2023 to be down a low single digit percentage compared to 2022.”

“We continue to expect non-GAAP SG&A expenses to increase by a high single digit percentage compared to 2022.”

“Reflecting the Tentarix collaboration closed in the third quarter as well as previously committed acquired IPR&D amounts and known milestone payments from existing collaborations, we now expect non-GAAP acquired IPR&D of approximately $1 billion in 2023.”

“Excluding these items, our full year R&D expense is consistent with our prior guidance in the low double digits.”

“On R&D, reflecting the accelerated enrollments and magrolimab discontinuation expenses, our full year non-GAAP R&D expense is now expected to grow approximately 15% in 2023 compared to 2022.”

“Moving to the rest of the P&L, we continue to expect non-GAAP gross margin to be approximately 86%.”

“we continue to expect a moderation of expense growth in 2024 and beyond.”