Q4 2023 Gilead Sciences Inc Earnings Call
Victoria: Good afternoon. Thank you for attending the fourth quarter and full year 2023 Gilead Sciences Earning Conference Call. My name is Victoria, and I'll be your moderator today.
Victoria: All lines will be muted during the presentation portion of the call with the opportunity for questions and answers at the end. I would now like to pass the conference over to your host, Jackie Ross. Thank you. You may proceed, Jackie
Jackie Ross: Thank you, Operator, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the fourth quarter and full year of 2023. The press release, slides, and supplementary data are available on the investors section of our website at Gilead.com. The speakers on today's call will be our chairman and chief executive officer, Daniel O'Day, our chief commercial officer, Johanna Mercier, our chief medical officer, Merdad Parsey, and our chief financial officer, Andrew Dickinson.
Jackie Ross: After that, we'll open the call to Q&A, where the team will be joined by Cindy Peretti, the executive vice president of KITE. Before we get started, let me remind you that we will be making forward-looking statements, including those related to Gilead's business, financial condition, and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business, and operations, financial projections and the use of capital, and 2024 financial guidance, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these A description of these risks can be found in the earnings press release and our latest SEC disclosure document. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statement. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet, as well as on the Gilead website. With that, I'll turn the call over to Dan. Thank you, Jackie.
Daniel O'Day: And good afternoon, everyone. The team and I are pleased you could join us today as we share the details of our full year and fourth quarter performance and the latest on our clinical portfolio. Starting with our full year performance, 2023 was a strong year for Gilead, with 7% growth in product sales, excluding Viclory, driven by HIV and oncology. HIV sales grew by almost $1 billion, with Big Tar V sales growing 14% to almost $12 billion and increasing its market share in the U.S. to 48%.
Daniel O'Day: Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just one year. This growth was split evenly between our KITE cell therapies and Tredelvi. The glory for COVID-19 contributed $2.2 billion in 2023, ahead of our expectations, but down year over year as expected, given the evolution of the pandemic. In the last two years combined, Gilead's base business has grown approximately $3.3 billion, or more than 7% annually, largely offsetting the decline in McGlury revenues over the same period.
Daniel O'Day: The consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst-rich phase for Gilead with more than 20 updates this year and many more to come beyond 2024. Starting with oncology, we expect at least 12 further updates by the end of 2024. These include phase 3 updates for Tredelvi in bladder and triple negative breast cancer, and results from the pivotal Phase 2 Imagine 1 study for our needle cell therapy and multiple myeloma, for which we saw encouraging Phase 1 data at the American Society of Hematology meeting in December. Also in cell therapy, we are very pleased to have shortened our manufacturing time for Yaskarta by another two days in the U.S., reinforcing our industry-leading median turnaround time, which is now at an anticipated 14 days.
Daniel O'Day: As you know, we did not reach the primary endpoint for EVOKE-01, our phase three trial for second line plus metastatic non-small cell lung cancer. Merdad will go into detail on this later, but while we did not see the outcome we hoped for, the data are encouraging on a number of levels, namely a numerical improvement in overall survival favoring Tredelvi, including in both squamous and non-squamous tumor A safety profile consistent with our product label that could continue to differentiate TRODELV versus other TROBE II ADCs.
Daniel O'Day: And while not statistically powered, a potential benefit for a pre-specified subpopulation that saw more than three months of median overall improvement. The team is evaluating next steps, given the data and the significant unmet need. And we look forward to discussing the data with regulators. Based on the totality of the results in both EVOKE-02 and EVOKE-01, we are confident in Tredelby's potential for patients with metastatic non-small cell lung cancer, including in earlier lines of therapy.
Daniel O'Day: In virology, we are looking forward to a very important year for our HIV portfolio. Among the many updates we are expecting are phase three data for lenicapavir in HIV prevention, and at least eight updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic, building on Gilead's decades of leadership in HIV. At COVID-19, today we are announcing that our Phase 3 trial, OakTree, evaluating Obaldesivir, did not meet its primary endpoint. We conducted this study to explore whether Obaldesivir could address the public health need that existed with COVID-19 for standard-risk patients. Again, Merdad will share details later, but essentially, because of the way things have evolved, the standard-risk population is now better able to fight COVID-19 without antiviral therapy. This made it more difficult for obaldesivir to show a benefit compared to placebo.
Daniel O'Day: We know that the world needs to be equipped for other viruses, and the broad antiviral activity of Obaldesivir, shown preclinically, means it has potential for other viral infections. The updates we are expecting in 2024 have the potential to unlock multiple opportunities across virology and oncology. With a broad portfolio where the risk is balanced, we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal. Before I hand over to the team for their updates, I'll move to slide six and recap that we executed well in 2023 and achieved all the remaining targeted goals that we expected to in the fourth quarter.
Daniel O'Day: We'll share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for Gilead. I'd like to thank the teams for their work in bringing us to this important, catalyst-rich phase for the company and for the strong commercial performance that gives us a firm foundation on which to build. With that, I'll hand it over to Joanne.
Joanne: Thanks, Dan, and good afternoon, everyone. Beginning on slide 8, total product sales for the full year were at the high end of our guidance range at $26.9 billion, reflecting solid base business growth, with total product sales excluding Viclory up 7% year-over-year to $24.7 billion. This was almost entirely offset by the expected decline in Vicklery sales. For the full year, declared sales were $2.2 billion, reflecting an uptick in hospitalizations at the end of 2023, though still below levels seen in 2022. Turning to the fourth quarter, on slide 9, total product sales were $7.1 billion, down 4% year over year. Our base business sales were roughly flat year over year at 6.3 billion, primarily driven by higher oncology sales, offset by lower HIV sales due to changes in channel mix that resulted in a lower average realized price, in addition to the expected decline in our portfolio of non-promoted products. Moving to slide 10.
Joanne: Our HIV business delivered very strong results for the full year, up 6% year over year to $18.2 billion, and contributing almost $1 billion in base business growth, primarily driven by demand, as well as higher average realized prices due to channel mix and inventory dynamics. More specifically, almost half of the full-year HIV growth was driven by higher demand, most notably by BicTarV, which delivered solid double-digit year-over-year growth of 14%, with annualized revenues now more than $12 billion. Already the clear market leader, BigTarget continues to demonstrate impressive share gains, growing almost 3% year-over-year in the fourth quarter of 2023 to approximately 48% of the market share in the U.S.
Joanne: This growth, once again, outpaced all other branded regimens for HIV treatment and represented the 22nd consecutive quarter of consecutive year-over-year share gains. For the fourth quarter, as highlighted on slide 11, HIV sales of $4.7 billion reflected strong demand in line with our expectations. On a year-over-year basis, this was offset by a lower average realized price due to channel mix that was notably favorable in the fourth quarter of 2022 and resulted in a decline of two percent.
Joanne: Sequentially, sales were up 1%, similarly driven by strong demand, as well as favorable inventory dynamics, partially offset by lower average realized prices due to channel mix. As we've noted previously, the pricing tailwinds we saw in the second half of 2022 and the first half of 2023 are not expected to repeat and will make year-over-year comparisons more challenging in the immediate term, as we saw in the fourth quarter. As a reminder, quarterly HIV growth is, in general, significantly more variable and less indicative of overall trends in the full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year. Factors include, first, gross net adjustments, which can be difficult to forecast due to the lag between product sales and claim payments that frequently occur in different quarters. Second, the timing of bulk government purchases, which contribute to overall demand but can have a significant negative impact on pricing in the quarter in which they occur.
Joanne: For example, certain discounted government segments are unpredictable in terms of bulk order timing, and this impacts overall average real life. And then, finally, the inventory billed by subchannel wholesalers and customers that typically occurs towards the end of the year. Historically, this happens in the fourth...
Joanne: In 2023, we saw the build start in the third quarter and continue, albeit to a lesser extent relative to prior years, into the fourth quarter. Overall, despite these quarterly variables, we remain confident that overall demand trends are strong and unchanged. With our HIV treatment market share above 70% in the U.S. and above 40% in PrEP, Gilead remains well-positioned to continue delivering demand-driven growth. For 2024, we expect HIV sales to grow approximately 4%, reflecting annual treatment demand growth of 2-3%, Victarvi market share gains, and continued double-digit growth in demand for HIV prevention. In terms of quarterly HIV revenue, keep in mind that the first quarter is always impacted by the reset of patient co-pays and deductibles. Additionally, we've historically seen inventory buildup in the fourth quarter that has led to notable drawdowns by wholesalers in the first quarter.
Joanne: In the first quarter of 2023, this contributed to HIV sales declining 12% sequentially, and we expect a similar decline in the 10 to 12% range for the first quarter of 2024. The continued strong performance of both BicTarvi and Dyscovi for PrEP is shown on slide 12. Overall, Gilead's leadership in HIV is unmatched, with a solid commercial portfolio and a robust pipeline of potentially best-in-class regimens to serve the daily oral, long-acting oral, and long-acting injectable market. And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024. Moving to the liver disease portfolio on slide 13, sales of $2.8 billion for the full year highlight the consistently strong and stable contribution from our liver disease portfolio.
Joanne: In the fourth quarter, sales were $691 million, flat year-over-year, and down 2% sequentially, primarily driven by unfavorable pricing dynamics, offset by higher HCV market share and our efforts to increase linkage to care, in addition to growing HCV demand in new and existing European geographies. In HCD, we continue to reinforce Gilead's leadership with market share of over 60% in the U.S. and over 50% While we continue to expect the rate of HDV news to start trending downwards over time, given the curative nature of our medicines, demand growth in both HDV and HBV is largely offsetting that headwind. On to slide 14. Clery sales continue to be highly variable, with the fourth quarter down 28% year over year, though up 13% sequentially due to higher COVID-related hospitalizations in the fourth quarter. For the full year, Bicklery's sales of $2.2 billion exceeded the expectations we set out at the beginning of 2023. Turning to slide 15.
Joanne: Our oncology business has achieved an annualized run rate that now exceeds $3 billion, with strong fourth-quarter sales of $765 million, up 24% year over year. In just three years, Tridelby revenue has grown to more than a billion dollars, and we continue to see strong growth across our approved indications and InCellTherapy. Sales approached $2 billion in 2023, and KITE remains firmly established as the leading provider of CAR T cell therapies globally. Looking more closely at Tridelby on slide 16, sales for the full year were $1.1 billion, up 56% year over year. For the fourth quarter, sales were $299 million, up 53% year-over-year and 5% sequentially.
Joanne: With over 30,000 patients treated to date, Tredelvi's solid demand trends continue to reinforce its robust clinical profile as the only Trope 2-directed antibody drug conjugate approved and available in multiple tumor types. Awareness and utilization continue to increase, driving notable share gains. In second-line metastatic triple-negative breast cancer, approximately one-third of patients are receiving Tredelvi, reinforcing its position as the leading regimen across the U.S. and other major markets. In pre-treated HR-positive HER2-negative metastatic breast cancer, we're encouraged to see share growth overall, driven by increasing adoption in the IHC0 setting, as well as continued use in HER2-low. Additionally, we look forward to potentially making Chudelvi more broadly available for metastatic bacterial cancer.
Joanne: Data from the Conformatory Phase III Tropics 04 study in the first half of the year could enable global filings and subsequent launches, as well as potentially drive adoption in the U.S., altogether expanding Tredelphi's potential reach to nearly 25,000 second-line plus patients with metastatic bladder cancer. Turning to slide 17, and on behalf of Cindy and the CITE team, cell therapy sales were $1.9 billion in 2023, growing 28% from 2022, driven by impressive growth, particularly outside the U.S., as we expanded our network of authorized treatment centers and secured reimbursement following recent approval. In the fourth quarter, cell therapy product sales were $466 million, up 11% year-over-year and down 4% sequentially, with strong growth in both Yascarta and Ticardus in Europe and other international markets, offset in part by near-term headwinds for Yascarta in the U.S., both from in-class and out-of-class competition.
Joanne: As previously discussed, CAR T class share of eligible second-line plus large B-cell lymphoma patients remains at roughly 15% in the U.S., as growth continues to be slower than anticipated, despite the compelling clinical data that suggests these therapies are potentially transformative for many patients. In Europe and other markets, Carty class share in this same second line plus setting continues to be stronger at approximately 30%.
Joanne: Following a restructuring in November, the CHITE team has been focused on extending the reach of self-therapies from primarily academic medical centers to community practices, especially in the US. In late 2023, we established partnerships with leading community networks, which include over 1,750 physicians nationally. We are certifying affiliated practices to become authorized treatment centers to provide kite cell therapy.
Joanne: So far, we've made notable headway across centers in the Southeast United States, for example, that operate more than 40 locations to serve cancer patients. We expect to see the initial impact of these initiatives in mid-2024. In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023. Importantly, alongside our 96% reliability rate, we're also thrilled to share that we have shortened our manufacturing time in the U.S. by two days for Yaskarta, bringing our anticipated median turnaround time to 14 days.
Joanne: This further extends our industry leadership in terms of manufacturing, and the CHI team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event. In conclusion, I'd like to thank our teams for a strong 2023 performance and setting up such great momentum for continued growth in 2024. The team is excited to continue to make our medicines accessible to all those who can benefit from them. And with that, I'll hand over the call to Merdad.
Merdad V. Parsey: Thank you, Johanna. We've had a busy start to 2024, and I'll begin by discussing the results of our EVOCA1 study in second line plus metastatic non-small cell lung cancer and our phase 3 oak tree study of obaldesivir in standard risk non-hospitalized patients with COVID-19. While we're disappointed that these studies did not meet their primary endpoints, we're also encouraged by what we're learning from the data to inform our clinical programs and support our commitment to deliver innovative new therapies for patients. Let me cover each of these readouts in turn. First, on slide 19, our phase 3 study of Tredelby and second line plus metastatic non-small cell lung cancer, EVOCA1, missed its primary endpoint of overall survival in this hard-to-treat setting.
Merdad V. Parsey: We plan to share the detailed data at the earliest opportunity, but in the meantime, we'd like to highlight what we believe to be an important set of observations from EVOCO 1 that give us continued confidence in Tridelby as a pipeline and a product and its potential to benefit some patients with lung cancer. We saw a numerical improvement favoring Tredelby, including in patients with both squamous and non-squamous histology
Merdad V. Parsey: This is encouraging for our ongoing Phase 3 Evoco3 First Line trial, evaluating Tredelvian PD-L1 high patients in combination with pembrolizumab. Importantly, 3W continues to demonstrate a potentially differentiated safety, efficacy, and tolerability profile within the adverse event profile that is consistent with our label. Further, TRDEL-V achieved more than three months of improvement in median overall survival in a pre-specified subgroup of patients non-responsive to their prior anti-PD-L1 therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to their last prior IO therapy and represented more than 60% of the trial population. This analysis was not output-controlled for formal statistical testing, and we are continuing to analyze these data. We will discuss these data with regulators and KOLs to determine the best path forward. As a reminder, we required all patients to have received prior I.O. therapy regardless of driver mutation status and responsiveness to prior I.O. was a stratification factor.
Merdad V. Parsey: Additional analyses, including Trope 2 expression, are ongoing, and we will share these data as quickly as possible. Based on these observations and the data from the ongoing EVOCO2 study, we remain confident in Tredelby's potential for patients with metastatic non-small cell lung cancer. For now, given these findings, we currently do not plan changes to our Phase 3 Evoco3 study that's enrolling as expected. Moving to slide 20, our novel twice-daily oral antiviral, Obaldesivir, did not demonstrate statistically significant symptom relief in standard-risk, non-hospitalized patients with COVID-19 in our phase 3 OBTREAT trial. Obaldesivir was well tolerated in this large study population, and we will share the data at a future medical meeting. Overall, the oak tree results reflect the decreasing severity and duration of COVID-19 symptoms observed in standard risk patients, driven by the evolution of variants and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated standard risk patients is now less than a week, as compared to almost two weeks at the peak of the pandemic. As a result, it was challenging for Obelisavir to show a benefit in the standard risk population.
Merdad V. Parsey: We continue to assess whether obaldesivir could address other viral infections given the broad antiviral activity that we have observed in preclinical data. Moving to another clinical update in oncology, the Phase 3 Enhance 3 trial evaluating megrolamab in frontline unfit AML has been discontinued based on a futility analysis and a higher observed incidence of grade 5 serious adverse events. Following the discontinuation of Enhance and Enhance 2 last year, we do not plan further development of Migrolimab in hematologic indications.
Merdad V. Parsey: Wrapping up on clinical updates, I want to thank all of those who were involved with EVOCA1, OakTree, and Enhance3. Every trial adds important advancements to our understanding of the treatment of these diseases and will inform our future development. We look forward to sharing more on that in due course. Transitioning to our HIV program on slide 21, we expect the phase 3 readout of Purpose 1, evaluating Lenacapavir for HIV prevention, later this year. Along with Purpose 2, expected in late 2024 or early 2025, Purpose 1 forms the basis of our potential regulatory filing. We continue to target our first approval for lenocapavir in prevention in late 2025, potentially making lenocapavir the first twice-yearly dosing regimen available for PrEP. Looking at our HIV program more broadly, you can see we will be sharing at least nine updates this year across our next-generation daily, weekly, three-monthly, and twice-yearly programs, all based on Lenacapavir, our novel first-in-class long-acting capsid inhibitor.
Merdad V. Parsey: We're excited to have over 75 presentations at CROI this year across Gilead-led and supported studies. Among them, some notable updates from our treatment pipeline include encouraging data from our Phase II Artistry I trial, evaluating Lenacapivir and Victagravir once-daily oral. We're exploring this combination as a potential additional option for biologically suppressed people living with HIV. Phase 1 data on GS1720, our once weekly oral integrase inhibitor, and Phase 2 data on Lenacapavir plus Izlatrovir, our once weekly oral combination in development with Merck.
Merdad V. Parsey: In the second half of this year, we look forward to providing an update on the Phase 2 trial evaluating Lenacapavir plus Benaz as a twice-yearly regimen. Turning to cell therapy on slide 22, you may have seen that the FDA recently proposed safety label changes for all approved CD19 and BCMA CAR T cell therapies, including Yaskarta and Takarta. There is no change to our confidence in the benefit-risk profile of Yaskarta and Jakarta. Based on analysis of our global safety database, with over 16,800 patients treated with Yaskarta, there has been no causal link established between Yaskarta and those reported to the FDA public safety dashboard. Additionally, no cases of T cell malignancies have been reported with Ticardis.
Merdad V. Parsey: In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December, showing that Yaskarta and Takartas continue to generate some of the longest follow-up and most robust data sets for cell therapies with the potential to transform patient lives. Also at ASH, our partner Arshtalix presented impressive updated data from the Phase I trial evaluating the needle cell in 38 patients with relapsed or refractory multiple myeloma. At a median follow-up of 26.5 months, median progression-free survival was not yet reached, despite 70% of patients having one or more high-risk prognosis factors. Given its potentially differentiated safety profile, with notably no delayed neurotoxicity to date, including Parkinsonism, Nidocell has the potential to become the best-in-class BCMA CAR-T. We look forward to sharing an update from the Pivotal Phase 2 Imagine 1 study and initiating an earlier line multiple myeloma trial later this year. In terms of manufacturing, while Kite is already the clear leader, we're pleased to highlight that the FDA has approved our updated process that reduces the turnaround time for Yaskarta in the U.S. from 16 days down to 14 days.
Merdad V. Parsey: This further extends our leadership in cell therapy, and we continue to identify additional opportunities to reliably bring these much-needed therapies to more patients as quickly as possible. Beyond manufacturing, we have eight ongoing cell therapy trials, of which four are evaluating new indications, and four are exploring earlier lines of therapy. As we formally wrap up 2023, on slide 23, I would like to acknowledge the work of our clinical teams who executed on our ambitious and broad portfolio that extends far beyond the list shown, including the advancement of eight new assets into the clinic, the delivery of 15 late-breaking oral presentations at major clinical congresses, and the initiation of three new Phase III programs. For 2024, our target milestones laid out on slide 24 include an update on Aceno 3 and first-line PD-L1-negative metastatic triple-negative breast cancer, an update on Tropix-O4 assessing overall survival in second-line metastatic or locally advanced bladder cancer, and an update on our Phase III Purpose I trial assessing lenin-capavir in HIV prevention, as previously highlighted.
Merdad V. Parsey: We are also looking forward to the start of phase three trials for Tredelphi and endometrial cancer and the artistry trials evaluating Lenacapavir and Bictegravir oral combination for HIV treatment. Our commitment to developing innovative new therapeutic options is unchanged, and we are confident that we will make progress on that commitment in 2024.
Andrew: Thank you, Merdad, and good afternoon, everyone. Starting on slide 26, we close the year with total product sales at $26.9 billion, at the top end of our guidance range due to a strong contribution from Vecluri. For the full year, total product sales, excluding Veclurie, grew 7%, driven by growth in both HIV and oncology. HIV increased 6% year over year, driven by BactarV, which grew 14% from 2022 to $11.8 billion. And oncology grew to $2.9 billion for the full year, an increase of $792 million, or 37% from 2022. Altogether, total product sales, excluding Veclurie, were $24.7 billion, modestly below the lower end of our full year guidance range, largely due to quarterly pricing variability in HIV in the fourth quarter.
Andrew: Importantly, HIV volumes were in line with our expectations, and we are confident in our full-year revenue growth expectations for HIV in 2024. The Glory revenue of $2.2 billion exceeded our guidance of approximately $1.9 billion and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022, full-year VECLRI revenue declined as expected and represented a headwind of more than $1.7 billion to total product sales.
Andrew: This was largely offset by almost $1.7 billion in growth from our base business, resulting in roughly flat total product sales year over year. On slide 27, our non-GAAP results were largely as expected, including gross margin and operating expenses, notably R&D, which showed disciplined moderation as we progressed through 2023. Non-GAAP EPS was $6.72, and within our guidance range, despite the incremental $0.10 of acquired IPR&D associated with the Arcelex and CompuGen partnerships that we announced following our guidance revision in November of 2023. A quick note that our GAAP results were impacted by some restructuring expenses, primarily related to our manufacturing strategy and our activities at KITE.
Andrew: As we discussed in the latter part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or $0.40 per share, and contributed to GAAP EPS of $4.40 for the full year. Moving to our fourth-quarter results, starting on slide 28, total product sales, excluding VetGlory, were $6.3 billion; including Veclury, total product sales of $7.1 billion were down 4% from the same quarter in 2022. As expected, Glory sales decreased year over year due to lower rates of COVID-19 related hospitalization. On slide 29, you can see that on a non-GAAP basis, product gross margin was 86%, down 66 basis points from the prior year. R&D expenses were $1.5 billion, down 6% year over year.
Andrew: Acquired IP R&D was $347 million, reflecting payments related to our collaborations with Arcelex, Assembly Biosciences, and Compugen and our Zinthera acquisition. SG&A was $1.6 billion, down 21% year over year, primarily related to the 2022 charge for the termination of the Everest collaboration that did not repeat in 2023. Excluding this 2022 charge, non-GAAP SG&A was down Operating margin was 39%, up from 37% in the fourth quarter of 2022, and the effective tax rate in the fourth quarter was 17% flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1.67 in the fourth quarter of 2022.
Andrew: I'll move now to slide 30 and our guidance, which assumes a generally stable macro environment, including FX at current rates, for the full year 2024. We expect total product sales in the range of $27.1 to $27.5 billion. We expect total product sales, excluding Veclurie, in the range of $25.8 to $26.2 billion, representing growth of 4 to 6% for our base business year over year. Within total product sales, and as Johanna discussed, we expect HIV revenue to grow approximately 4%, and we expect VECLRI sales of approximately 1.3 billion dollars, although as always, we caution you that VECLRI sales remain highly variable depending on hospitalization rates. We do not expect to update our VECLRI guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infection. Moving to the rest of the P&L, and on a non-gap basis.
Andrew: We expect product growth margins to range between 85 and 86 percent, modestly lower than the 86.1 percent reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low- to mid-single-digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active Phase III programs. We expect acquired IP R&D to be approximately $3
Andrew: Consistent with our approach in 2023, we will highlight incremental acquired IPR&D expenses as we announce new transactions and update our guidance each quarter, and we expect SG&A to decline by a mid-single-digit percentage compared to 2023. Excluding the $525 million legal settlement in 2023, we expect SG&A to grow in the low to mid-single-digit percentage range compared to SG&A As a result, we expect our operating income for 2024 to be between $11.2 and $11.7 billion. Additionally, we expect our effective tax rate to be approximately 19%.
Andrew: And finally, we expect our non-GAAP, non-diluted EPS to be between $6.85 and $7.25 per share for the full year, and GAAP-diluted EPS to be between $5.15 and $5.55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10 to 12% range from Q4 2023, similar to what we saw in the first quarter of 2023, and cell therapy to be flat to slightly higher from Q4 2023. Moving to capital allocation on slide 31. Our priorities have not changed. In 2023, we will return $4.8 billion to our shareholders. This included $3.8 billion in dividend payments and $1 billion in share repurchase. Fourth quarter share repurchases were $150 million.
Andrew: For 2024, we announced today a 2.7% increase in our quarterly cash dividend to 77 cents per share, and we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution, as well as additional repurchases on an opportunistic basis.
Operator: With that, I'll invite the operator to begin the Q&A. Of course, Andrew. We will now begin the question and answer session. In the interest of time, we ask that everyone limit their questions to one. Thank you, everyone. See you.
Operator: If you have a question, please start with 1 and we will go on. Great. I'd like to answer that question, followed by two. Again, two questions, let's start with one, as you're able to hear using the speaker phone.
Operator: As a reminder, if you are using a speakerphone... Please remember to pick up your handset before asking a question. We will pause here briefly as questions are registered. Our first question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.
Tyler Van Buren: Hey guys, good afternoon. Regarding the 2024 product sales guidance, I understand you guys are guiding to a near 900 million sales drop off year over year for VickLurie, but the guidance ex-VickLurie looks to be 5% year over year growth at the midpoint versus 7% for this year. So what do you view as some of the levers to the ex-VickLurie product sales guidance in 24 where we could see upside? Thanks, Tyler. Welcome. Let's have Andy start, please. Hey Tyler, it's Andy.
Andy: Thanks for the question. You're absolutely right. Our product sales guidance for products excluding Vecluri implies 4 to 6% growth year over year, again continuing the trend of strong growth that you've seen over the last two years. I'd also highlight that it implies a substantial moderation of our operating expense growth, which is an important piece of the puzzle that we spent a lot of time talking about. As for your question specifically on product growth, the growth drivers for 2024 are the same as the growth drivers last year.
Andy: We continue to see strong growth in our HIV business. As you see in the quarter, you really need to focus on the full year for HIV to see the growth trends. And we saw another year of very strong growth across our HIV business for the full year in 23. We expect the same thing in 24.
Andy: And you heard on the call that we were expecting at least 4% growth for the HIV business next year. And then, of course, the cell therapy business and Tridelvia are expected to continue to grow as well. So those are the key growth drivers. We look forward to updating you throughout the year, but we're excited about the setup as we move into 2024. Thank you so much.
Andy: Of course. Thank you so much for your question. Our next question comes from the line of Dalveen Ritzer with Goldman Sachs. Your line is now open.
Dalveen Ritzer: Good afternoon, thanks for taking my question. On business development, you have noted the potential for a $5 to $6 billion deal in oncology or INI. Where are you seeing the greatest opportunity to leverage your current clinical and commercial infrastructure? Thank you.
Dan: Maybe I'll start and then ask others to add, but I appreciate the question. I think just to reinforce our M&A strategy, I mean, nothing has changed from a business development perspective, and particularly that's against the context of the background of nearly doubling our clinical trials underway over the past four years, and multiple late-stage results. As you know, we're still expecting more than 20 results still this year, and against the backdrop of no significant patent expirations in our business until the early parts of the next decade. So I think we'll continue to be opportunistic about pursuing business development in the three areas that we are focused on, which are obviously virology, oncology, and inflammation. We'll be driven by science.
Dan: We continue to articulate that building our late research and early development pipeline is probably one of our biggest focuses, and we'll continue to look at later stage deals as they fit into our portfolio and our range. It might also be important to note that we are back to pre-immunomatics levels now relative to our leverage ratios, and so we're comfortable with our ability to put capital to work. But nothing has changed, and we feel we have everything within Gilead right now to achieve our ambitions over the second half of this decade. Victoria, may we have our next question, please? Of course. The next question comes from Linus Carter Gould with Barclays. Your line is now open. Hi, this is Leon. Hi, this is Leon Wang on behalf of Carter.
Leon Wang: Thanks for taking my question. So, at this point, what conviction do you have that a needle cell will differentiate neurotox or Parkinsonian? versus your competitors. And if the lack of Neurotox data we capitulate later. Would that be the..., and how important would that be in the market? Thank you.
Cindy Pretty: I'll handle that. Thank you. Thank you for the question. I think with the Ameda cell data, we expect to complete enrollment in our IMAGINE-1 study this year, with 100 patients' worth of data. And obviously, we're going to continue to look for safety signals, neurotoxins, as you suggested, but to date, we have not observed any.
Cindy Pretty: Your second part of that question was, do we see that as a differentiator? And I would definitely see that as a differentiator in the marketplace if we were to come forward with a differentiated safety profile. I think the other component to remind you of is that we also believe it's possible to have a differentiated efficacy profile. And today, based on the D domain and our transduction efficiency, we're able to use half the dose that we're seeing with our competitors, and that could play both with safety and efficacy. Thank you.
Victoria: Victoria, are you ready for our next question? Of course, our next question comes from the line of Terrence Flynn with Morgan Stanley. Your line is now open. Thank you so much for taking the question. I was just wondering if you could speak to your confidence level in TRDEL-V in the frontline non-small cell lung trial setting here, given the Evoque-01 data, and if you're considering any potential changes to that frontline trial as a result. Thank you. Hi Terrence, this is Merdad.
Merdad: You know, we're looking forward to sharing the data with everyone as quickly as we can. Probably one of the most important things in that data set that confirmed where we were before is that we have not seen a difference in response rates between squamous cell carcinoma and non-squamous cell carcinoma. I think that was a bit of an overhang in the fall, and as we had mentioned earlier, we have not seen that to date, and that has been bolstered by the results of VOC-01. So we do think that that increases our confidence that we don't need to think about it. Now, there are other analyses we need to do to make sure that there are other predictors of response or not, and we'll be doing that, and we'll be sharing that over time, but right now, our overall confidence in Tridel V, broadly speaking, remains very high, three approvals, and we have a broad development program against which we are executing really well.
Merdad: We continue to have additional trials that we'll read out this year in Phase 3, specifically the TROFEO4 study that will be looking at the bladder cancer confirmation study with, hopefully, an OS signal. That study could actually give us beyond... A confirmationary trial in the U.S. allows us to open conversations with regulators outside the U.S. And then we have promised an update on Aceno 3 in breast cancer, which we also think will broaden that.
Merdad: And then we now have a number of trials going on in a variety of indications, including ones we've mentioned in, for example, endometrial cancer. So overall, what we've seen in VOCA01 and we're looking forward to sharing with you really maintains our level of enthusiasm about Tridelby's long-term potential from an efficacy and safety standpoint across the board, and we have no plans to change that at Our next question comes from the line of, "Yes, ma'am." Our next question comes from a line from Omar Rafat with Evercore. Your line is now open.
Umer Raffat: Hi guys. Thanks for taking the time... Hi guys. Thanks for taking my question. Look, it's very well understood for folks in the biopharma community that no one can truly understand the full safety profile of any new drug based on phase one data. But this point has a lot of implications for your TAF litigation, obviously. So my question is, in a scenario where the Supreme Court takes up your petition, would that potentially be a venue where you could prove the level of evidence that's actually needed to make a decision on the exception to theory and the type of decisions to make?
Andy: All right, I think Andy's going to take this one. Hi Amir. Yeah, thanks for the question. Yes, of course. I mean, in front of the Supreme Court, just like the appellate court, we'll be able to present the facts and our arguments, as you'd expect. If you look at some of the briefing documents in the appellate court, I think they spell that out very clearly in terms of what happened over time with the development of TAF and what we knew at different points in time, and that would be available, as you would expect, not only to the appel And, of course, those same facts would be presented at any trial if we ever get to that point.
Andy: One other update on the TAF litigation. Again, nothing's changed from our perspective. We continue to have a lot of confidence. The one update I can provide is that the very first trial in the federal court has been dismissed as of yesterday, I believe. So it now looks like, and again, this is consistent, as you know, with the thousands of other cases. I think there are now over 5,300 cases that have been dismissed by the courts, over 4,300 in the California state courts and over 1,000 in the federal courts before they get to trial.
Andy: So the first bellwether trial in the federal courts, Umar, will now be in November instead of April. So we'll keep you up to date, and thanks for your question. Our next question comes from Linus. Olivia Brayer with Cantor Fitzgerald. Your line is now open. Hey, good afternoon.
Olivia Brayer: Thank you for the question. What were some of the dynamics that happened with Yescarta this quarter? And how should we be thinking about growth for 2024 from your cell therapy franchise, just in light of the sequentially down quarter in 4Q? Thanks a lot, Olivia, for the question. This is Cindy.
Cindy: You know, we continue to be leaders in cell therapy, and I think the piece that Johanna mentioned is that we are looking at how we can expand on the existing ATCs. So the dynamics that we observed this quarter were capacity constraints within the existing ATCs that we have. We saw a little bit of in-class and out-of-class competition, and in parallel, we have been continuing to work on expanding our ATCs. So today, we have over 400 ATCs globally. We are moving out of urban centers and those academic centers into the community to meet patients where they are.
Cindy: As Andy suggested, bringing those ATCs in the community is going to be a really important part of our future strategy, but it does take a little bit longer than bringing an academic center up. So we expect to be flat to slightly up in quarter one, and you'll start to see that return to growth in the second half of the year. Our next question comes from the line of Geoff Meacham. Bank of America, your line is now open.
Geoff Meacham: Great. Thank you. You have another one on cell therapy, but more on profitability. This is a franchise that's almost $2 billion in sales. You guys have improved the turnaround time. You've reached scale.
Andy: You've treated a ton of patients. What can you tell us about the progress that you've made to making this a profitable franchise? I'm just thinking not just about the current products but also looking out five years plus. Thanks. Hey, Geoff, it's Andy.
Andy: Thanks for the question. It's a great question. You're absolutely right. The cell therapy business has made tremendous progress over the last five or six years. And evidenced most recently by the faster turnaround time in manufacturing that we talked about in our prepared remarks, going from 16 days to 14 days. And again, it's just the beginning from our perspective of what we can continue to do with this business. So while we don't provide specific guidance, we've said when we announced the kite transaction that we expected to be profitable, breakeven, and accretive by the end of year four. We got there shortly after that. All of the metrics that we look at on the business have improved over time. We've continued to make significant progress on our manufacturing efficiency, manufacturing costs, despite the fact that we've opened three global manufacturing centers. And each time you So I'm really proud of what the team has done.
Cindy Pretty: And same thing on operating costs. You see, in the fourth quarter, we announced some restructuring charges, Jeff, that hit our gap results. Part of that was a restructuring at Kite City, and her team looked at the structure and made changes to the structure that we think will continue to drive growth and efficiency in the business over the long run. 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. We're really growing the business, Jeff, as you know, for long-term sustainability and growth and less near-term profitability. But it's certainly exciting that the business is doing as well as it is. I think the only thing I would add to Andy's comment is that beyond the three manufacturing facilities, we also have our own viral vector facility. So given the fact that viral vector has had some supply challenges, that's something that we are not suffering from. So we own the sort of end to end cost of goods for our product.
Victoria: May we have our next question, please, Victoria? Of course. Our next question comes from the line of Michael Yee with Jeffrey. Your line is now open.
Michael J. Yee: Thank you for the question. We had an HIV question. There were some comments around the dynamics of the channel mix as it relates to HIV pricing, and I was wondering if you could just remind us about what the driver of the benefit was in 22 and 23, and how that changed as we go into 24, and why the typical comp is that a change in mix between commercial and Medicaid, or maybe just explain that. That would help us understand what's going on there for 23. 24.
Joanna: Thank you. Sure, Michael. Hi, it's Joanna.
Joanna: Let me take that one. So what you're referring to is actually, we saw some pricing favorability in Q4 of 22 in the first half of 2023. That pricing favorability was mainly driven by just the inflation being so high. And therefore, you know, some of our rebates are actually based on that inflation rate.
Joanna: And so, therefore, there was actually upside during those quarters, but we knew that that was not going to repeat itself. So we had kind of shared with you, I think, from Q3 on that this was going to normalize. And so that was kind of what happened in the first half of 2023. As we think about the second half of 2023, and namely, the fourth quarter, what we did see there was very strong demand. And that continued throughout the whole year.
Joanna: But we had some fluctuations, some quarterly variability, mainly due to channel mix and more government channels resulting in a lower average realized price because of higher rebates. And so you really have to look at it on a full year basis. And so that's why it's so important to know that HIV performance will always have some quarterly variability, and we always need to look at the full year to really get the full picture of what's going on.
Joanna: HIV for the full year of 2023 grew 6%, with nearly a billion dollars in revenue growth, driven by Big Tar V, obviously growing at 14%, and at 48% share with 3% share growth in that year, outpacing all competitors. And so we're really proud of the demand-driven results that we've seen in 2023. And as we think about 2024, and our predictions for 2024, we believe that, you know, our expectations are going to be in line with HIV treatment, which is still about two to three points. Layer on top of that the demand growth from the CARVI and DSCOVI for PrEP. And that's why we're expecting about a 4% growth in HIV.
Joanna: So that gives you the full picture of what's going on and what happened in the past. So we don't expect that on a yearly basis, but on a quarterly basis, we do expect that variability, and I would expect that that will continue as we move forward. Our next question comes from Chris Schott with J.P. Morgan. Your line is now open.
Chris Schott: Great. Thanks so much for the question. Can you just talk about the TGIT program and what drove the decision to step up your investments here? And maybe, as part of that, can you elaborate a little bit more on the decision to de-emphasize the PD-L1 high population in favor of the all-comer study? Sorry, any color that would be appreciated.
Andy: Thank you. Hey, Chris, it's Andy. Maybe I'll start with the TIGIT program and the revised agreement with Arcus that we announced last week. And then Merdad, can you answer the second part of your question? You know, it's relatively simple.
Merdad: If you step back, you've heard us say this before, but I'd reiterate that we value the partnership that we have with Arcus and the programs that their team has developed. And the recent updates to your question about the partnership really allow both companies to more efficiently deploy our teams and capital. We also focused on streamlining decision making, and the additional capital allows us to expand the overall clinical study footprint. So there are a number of things that both companies accomplished through the amendment.
Merdad: It does reinforce our support and belief in their programs broadly, not just TIGIT, but there's a lot to be excited about there that you'll see play out over the coming years, and, excuse me, this is Merdad. I think you're referring to the ARC-10 study and as you may recall we started that study together with ARCIS back in 2021 outside the U.S. with a chemocomparator arm and at the time there was really limited access to PD-1, PD-L1 inhibitors outside the U.S. and so we subsequently updated that study March of last year to include PD-L1 inhibitors as the standard of care was evolving, It took us time to get this all going, and while that was happening, we had a number of competitors launch similar trials in the space with their TIGID antibodies.
Merdad: So, as a result of all that, the enrollment for the ARC-10 trial wasn't as robust as we had hoped for and as it had been. And STAR-121, which is the All Comers Study, was recruiting very well. And so, we decided to really prioritize our efforts for that all-comers population where we think we could be first or second in class. And it was really a priority to ensure that we could stay ahead and keep moving the molecules forward as quickly as possible.
Brian Abrahams: Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open. Hi, good afternoon.
Thanks so much for taking my question. I realize this is pending KOL and regulatory discussions, but I was wondering if you could frame the potential next steps for the PD-L1 poor responders. Do you think this is a viable population for Tredelby and Second Line Lung, or might you also consider running another study in that population? And along those lines, I'm curious what you're expecting to see from the updated EVOKE-02 data this year and how that might shape your overall plans for Tredelby and Lung. Thanks. Sure, this is Merdad again, Brian, so maybe I'll take the second part first. On Invoco 2, as you can imagine, we showed last year's ORR data and those
Operator: My name is Victoria, and I'll be your moderator today. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. I would now like to pass the conference over to your host, Jackie Ross. Thank you, you may proceed, Jackie.
Jackie Ross: Thank you, operator, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the fourth quarter and full year of 2023. The press release, slides, and supplementary data are available on the investors section of our website at Gilead dot com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Merdad Parsey, 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 Perettie, the Executive Vice President of Kite.
The press release slides and supplementary data are available on the investors section of our website at Gilead Dot com. The speakers on today's call will be our chairman and Chief Executive Officer, Daniel O'day, Our Chief Commercial Officer, Joanna Mercy, a our chief Medical Officer, Mehrdad, Parsi 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 Peretti, The executive Vice President of kite.
Before we get started let me remind you that we will be making forward looking statements, including those related to Gilead business, financial condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital, and 2024 financial guidance, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward looking statements. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release in our supplementary data sheet as well as on the Gilead website. With that I'll turn the call over to Dan.
<unk> all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
A description of these risks can be found in the earnings press release, and our latest SEC disclosure documents. All forward looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward looking statements non-GAAP financial measures will be used to help you understand the company's underlying business performance.
The GAAP to non-GAAP reconciliations are provided in the earnings press release in our supplementary data sheet as well as on the Gilead website.
Good afternoon. Thank you for attending the fourth quarter and full year 2023, Gilead Sciences, earning conference call. My name is Victoria and I'll be your moderator for today.
With that I'll turn the call over to Dan.
Daniel O'Day: Thank you, Jackie, and good afternoon, everyone. The team and I are pleased you could join us today as we share the details of our full year and fourth quarter performance, and the latest on our clinical portfolio, starting with our full year performance. 2023 was a strong year for Gilead, with 7% growth in product sales, excluding Veklury, driven by HIV and oncology. HIV grew by almost $1 billion, with Biktarvy sales growing 14% to almost $12 billion, and increasing its market share in the US to 48%. Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just one year. This growth was split evenly between our kite cell therapies and Trodelvy. Veklury for COVID-19 contributed $2.2 billion in 2023, ahead of our expectations, but down year over year as expected, given the evolution of the pandemic. In the last two years combined, Gilead's base business has grown approximately $3.3 billion, or more than 7% annually, largely offsetting the decline in Veklury revenues over the same period. The consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for Gilead, with more than 20 updates this year and many more to come beyond 2024.
All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end I would now like to pass the conference over to your host Jackie Ross. Thank you you May proceed Jackie.
Jackie Ross: Thank you operator, and good afternoon, everyone.
Jackie Ross: After market close today, we issued a press release with earnings results for the fourth quarter and full year of 2023.
Oh geez. HIV grew by almost $1 billion with big target sales growing 14% to almost 12 billion and increasing its market share in the U S to 48%. Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just one year. This growth was split evenly between our type cell therapies and fidelity. Thanks, Larry for COVID-19 contributed $2 2 billion in 2023 ahead of our expectations, but down year over year as expected given the evolution of the pandemic. In the last two years combined Julia its base business has grown approximately $3 3 billion. Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
HIV grew by almost $1 billion with big target sales growing 14% to almost 12 billion and increasing its market share in the U S to 48%. Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just one year. This growth was split evenly between our type cell therapies and fidelity. Thanks, Larry for COVID-19 contributed $2 2 billion in 2023 ahead of our expectations, but down year over year as expected given the evolution of the pandemic. In the last two years combined Julia its base business has grown approximately $3 3 billion. Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
The press release slides and supplementary data are available on the investors section of our website at Gilead Dotcom. The speakers on today's call will be our chairman and Chief Executive Officer, Daniel O'day, Our Chief commercial officer, joining Mercy, a our chief Medical Officer, Murdock, Percy and our Chief Financial Officer, Andrew Dickinson.
Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just one year. This growth was split evenly between our type cell therapies and fidelity. Thanks, Larry for COVID-19 contributed $2 2 billion in 2023 ahead of our expectations, but down year over year as expected given the evolution of the pandemic. In the last two years combined Julia its base business has grown approximately $3 3 billion. Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
This growth was split evenly between our type cell therapies and fidelity. Thanks, Larry for COVID-19 contributed $2 2 billion in 2023 ahead of our expectations, but down year over year as expected given the evolution of the pandemic. In the last two years combined Julia its base business has grown approximately $3 3 billion. Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
Jackie Ross: After that well open the call to Q&A, where the team will be joined by Cindy Peretti Executive Vice President of tight before we get started let me remind you that we will be making forward looking statements, including those related to gilead business financial condition and results of operations plans and expectations with respect to products product can.
Thanks, Larry for COVID-19 contributed $2 2 billion in 2023 ahead of our expectations, but down year over year as expected given the evolution of the pandemic. In the last two years combined Julia its base business has grown approximately $3 3 billion. Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
In the last two years combined Julia its base business has grown approximately $3 3 billion. Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
Or more than 7% annually largely offsetting the decline in the glory revenues over the same period the consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
Jackie Ross: It's corporate strategy business and operations financial projections and the use of capital in 2024 financial guidance, all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
Jackie Ross: A description of these risks can be found in the earnings press release, and our latest SEC disclosure documents. All forward looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward looking statements non-GAAP financial measures will be used to help you understand the company's underlying business performance.
Daniel O'Day: Starting with oncology, we expect at least 12 further updates by the end of 2024. These include Phase III updates for Trodelvy in bladder and triple negative breast cancer, and results from the pivotal Phase II iMMagine-1 study for Anito-cel in multiple myeloma, for which we saw encouraging Phase I data at the American Society of Hematology meeting in December. Also in cell therapy, we are very pleased to have shortened our manufacturing time for Yescarta by another two days in the US, reinforcing our industry leading median turnaround time, which is now at an anticipated 14 days. As you know, we did not reach the primary endpoint for Evoke-01, our Phase III trial for second line plus, metastatic, non-small cell lung cancer. Merdad will go into detail on this later, but while we did not see the outcome we hoped for, the data are encouraging on a number of levels. Namely, a numerical improvement in overall survival favoring Trodelvy, including in both squamous and non-squamous tumors. A safety profile consistent with our product label that could continue to differentiate Trodelvy versus other TROP2-adcs, and while not statistically powered, a potential benefit for a pre-specified subpopulation that saw more than three months median overall improvement. The team is evaluating next steps given the data and the significant unmet need, and we look forward to discussing the data with regulators. Based on the totality of the results in both Evoke-02 and Evoke-01, we are confident in Trodelvy's potential in patients with metastatic non small cell lung cancer, including in earlier lines of therapy.
Jackie Ross: The GAAP to non-GAAP reconciliations are provided in the earnings press release in our supplementary data sheet as well as on the Gilead website.
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Jackie Ross: With that I'll turn the call over to Dan.
Thank you Jackie and good afternoon, everyone. The team and I are pleased you could join US today as we share the details of our full year and fourth quarter performance and the latest on our clinical portfolio starting with our full year performance 2023 was a strong year for gilead with 7% growth in product sales, excluding burglary, driven by HIV and I'll call.
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Jackie Ross: Oh geez.
Jackie Ross: HIV grew by almost $1 billion with big targets sales growing 14% to almost 12 billion and increasing its market share in the U S to 48%.
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Jackie Ross: This growth was split evenly between our kite cell therapies and Philadelphia.
Jackie Ross: The Fleury for COVID-19 contributed $2 $2 billion in 2023 ahead of our expectations, but down year over year as expected given the evolution of the pandemic.
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Jackie Ross: <unk> growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio.
Daniel O'Day: In virology, we are looking forward to a very important year for our HIV portfolio. Among the multiple updates we are expecting are the Phase III data for Lenacapavir in HIV prevention, and at least eight updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic, building on Gilead's decades of leadership in HIV. In COVID-19, today we are announcing that our Phase III trial Oaktree, evaluating Obeldesevir, did not meet its primary endpoint. We conducted this study to explore whether Obeldesevir could address the public health need that existed with COVID-19 for standard risk patients. Again, Merdad will share details later, but essentially, because of the way things have evolved, the standard risk population is now better able to fight COVID-19 without antiviral therapy. This made it more difficult for Obeldesevir to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses, and the broad antiviral activity of Obeldesevir shown pre-clinically means it has potential for other viral infections. The updates we are expecting in 2024 have the potential to unlock multiple opportunities across virology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Daniel O'Day: In virology, we are looking forward to a very important year for our HIV portfolio. Among the multiple updates we are expecting are the Phase III data for Lenacapavir in HIV prevention, and at least eight updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic, building on Gilead's decades of leadership in HIV. In COVID-19, today we are announcing that our Phase III trial Oaktree, evaluating Obeldesevir, did not meet its primary endpoint. We conducted this study to explore whether Obeldesevir could address the public health need that existed with COVID-19 for standard risk patients. Again, Merdad will share details later, but essentially, because of the way things have evolved, the standard risk population is now better able to fight COVID-19 without antiviral therapy. This made it more difficult for Obeldesevir to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses, and the broad antiviral activity of Obeldesevir shown pre-clinically means it has potential for other viral infections.
Among the multiple updates we are expecting or the phase III data for <unk> in HIV prevention. And at least eight updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic building on gilead decades of leadership in HIV. And COVID-19 today, we are announcing that our phase III trial Oaktree evaluating <unk> desert here did not meet its primary endpoint. We conducted this study to explore whether <unk> could address the public health need that existed with COVID-19 for standard risk patients. Again, my dad, who will share details later, but essentially because of the way things have evolved the standard risk population is now better able to fight COVID-19 without anti viral therapy. This made it more difficult for <unk> to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Jackie Ross: This is a catalyst rich base for gilead with more than 20 updates this year and many more to come beyond 2024.
And at least eight updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic building on gilead decades of leadership in HIV. And COVID-19 today, we are announcing that our phase III trial Oaktree evaluating <unk> desert here did not meet its primary endpoint. We conducted this study to explore whether <unk> could address the public health need that existed with COVID-19 for standard risk patients. Again, my dad, who will share details later, but essentially because of the way things have evolved the standard risk population is now better able to fight COVID-19 without anti viral therapy. This made it more difficult for <unk> to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Jackie Ross: Starting with oncology, we expect at least 12 further updates by the end of 2024. These include phase III updates for <unk> in bladder in triple negative breast cancer and results from the pivotal phase III imagine one study for <unk> to sell in multiple myeloma for which we saw encouraging phase one data at the American Society of Hematology.
These are milestones that could bring us closer to our goal of helping to end the HIV epidemic building on gilead decades of leadership in HIV. And COVID-19 today, we are announcing that our phase III trial Oaktree evaluating <unk> desert here did not meet its primary endpoint. We conducted this study to explore whether <unk> could address the public health need that existed with COVID-19 for standard risk patients. Again, my dad, who will share details later, but essentially because of the way things have evolved the standard risk population is now better able to fight COVID-19 without anti viral therapy. This made it more difficult for <unk> to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
And COVID-19 today, we are announcing that our phase III trial Oaktree evaluating <unk> desert here did not meet its primary endpoint. We conducted this study to explore whether <unk> could address the public health need that existed with COVID-19 for standard risk patients. Again, my dad, who will share details later, but essentially because of the way things have evolved the standard risk population is now better able to fight COVID-19 without anti viral therapy. This made it more difficult for <unk> to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Jackie Ross: G meeting in December also in cell therapy, we are very pleased to have shortened our manufacturing time for Ya <unk> by another two days in the U S reinforcing our industry, leading media and turnaround time, which is now at an anticipated 14 days.
Again, my dad, who will share details later, but essentially because of the way things have evolved the standard risk population is now better able to fight COVID-19 without anti viral therapy. This made it more difficult for <unk> to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Jackie Ross: As you know we did not reach the primary endpoint for a vote Oh, one our phase III trial for second line plus metastatic non small cell lung cancer.
This made it more difficult for <unk> to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Jackie Ross: Where that will go into detail on this later, but while we did not see the outcome. We hoped for the data are encouraging on a number of levels, namely a numerical improvement in overall survival favoring tread lv, including in both squamous and non squamous tumors.
We know that the world needs to be equipped for other viruses and the broad antiviral activity of <unk> desert shown pre clinically means it has potential for other viral infections. The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology. With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Daniel O'Day: The updates we are expecting in 2024 have the potential to unlock multiple opportunities across virology and oncology. With our broad portfolio, where the risk is balanced, we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal. Before I hand over to the team for their updates, I'll move to slide six and recap that we executed well in 2023 and achieved all of the remaining targeted goals that we expected to in the fourth quarter. We will share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for Gilead. I'd like to thank the teams for their work in bringing us to this important catalyst rich phase for the company and for the strong commercial performance that gives us a firm foundation on which to build. With that I'll hand it over to Johanna.
Safety profile consistent with our product label that could continue to differentiate <unk> versus other trop, two adcs and while not statistically powered a potential benefit for a pre specified subpopulation that saw more than three months median overall improvement.
With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Jackie Ross: <unk> is evaluating next steps given the data and the significant unmet need and we look forward to discussing the data with regulators.
Before I hand over to the team for their updates I'll move to slide six and recap that we executed well in 2023 and achieved all of the remaining targeted goals that we expected to in the fourth quarter. We will share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for gilead. I'd like to thank the teams for their work in bringing us to this important catalyst rich phase for the company and for the strong commercial performance that gives US a firm foundation on which to build. With that I'll hand, it over to Joanna.
Jackie Ross: Based on the totality of the results in both evoke owed to <unk>, we are confident in <unk> potential in patients with metastatic non small cell lung cancer, including in earlier lines of therapy and.
We will share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for gilead. I'd like to thank the teams for their work in bringing us to this important catalyst rich phase for the company and for the strong commercial performance that gives US a firm foundation on which to build. With that I'll hand, it over to Joanna.
Jackie Ross: And Barology, we're looking forward to a very important year for HIV portfolio among.
Jackie Ross: Among the multiple updates we are expecting or the phase III data for Atlantic cap of your HIV prevention.
I'd like to thank the teams for their work in bringing us to this important catalyst rich phase for the company and for the strong commercial performance that gives US a firm foundation on which to build. With that I'll hand, it over to Joanna.
Jackie Ross: And at least eight updates from our HIV treatment program.
Jackie Ross: These are milestones that could bring us closer to our goal of helping to end the HIV epidemic building on gilead decades of leadership in HIV.
With that I'll hand, it over to Joanna.
Johanna Mercier: Thanks, Dan, and good afternoon, everyone. Beginning on slide eight, total product sales for the full year were at the high end of our guidance range at $26.9 billion dollars, reflecting solid base business growth with total product sales excluding Veklury at 7% year over year to $24.7 billion. This was almost entirely offset by the expected decline in Veklury sales. For the full year, Veklury sales were $2.2 billion dollars, reflecting the uptick in hospitalized patients at the end of 2023, though still below levels seen in 2022.
Jackie Ross: And COVID-19 today, we are announcing that our phase III trial oak tree evaluating <unk> desert here did not meet its primary endpoint. We conducted this study to explore whether <unk> could address the public health need that existed with COVID-19 for standard risk patients.
This was almost entirely offset by the expected decline in Victoria South. For the full year. <unk> sales were $2 $2 billion. The uptick in hospitalized patients at the end of 2023 and still below levels seen in 2022.
Jackie Ross: Again, my dad will share details later, but essentially because of the way things have evolved the standard risk population is now better able to fight COVID-19 without anti viral therapy.
For the full year. <unk> sales were $2 $2 billion. The uptick in hospitalized patients at the end of 2023 and still below levels seen in 2022.
<unk> sales were $2 $2 billion. The uptick in hospitalized patients at the end of 2023 and still below levels seen in 2022.
The uptick in hospitalized patients at the end of 2023 and still below levels seen in 2022.
This made it more difficult for <unk> to show a benefit compared to placebo.
Johanna Mercier: Turning to the fourth quarter on slide nine, total product sales were $7.1 billion dollars, down 4% year over year. Our base business sales were roughly flat year over year at $6.3 billion, primarily driven by higher oncology sales, offset by lower HIV sales due to changes in channel mix that resulted in lower average realized price, in addition to the expected decline of our portfolio of non-promoted products.
Jackie Ross: We know that the world needs to be equipped for other viruses and the broad antiviral activity of all desert shown pre clinically means it has potential for other viral infections.
Jackie Ross: The updates we were expecting in 2024 have the potential to unlock multiple opportunities across barology and oncology.
In addition to the expected decline of our portfolio of non promoted products.
Jackie Ross: With our broad portfolio, where the risk is balance we look forward to following the science and continuing to make a positive impact for patients and communities.
Moving to slide 10. Our HIV business delivered very strong results for the full year, up 6% year over year to $18.2 billion dollars and contributing almost $1 billion in base business growth, primarily driven by demand as well as higher average realized price due to channel mix and inventory dynamics. More specifically, almost half of the full year HIV growth was driven by higher demand. Most notably by Biktarvy, which delivered solid double-digit year over year growth of 14%, with annualized revenues now more than $12 billion dollars. Already the clear market leader, Biktarvy continues to demonstrate impressive share gains, growing almost 3% year over year in the fourth quarter of 2023 to approximately 48% share in the US. This growth once again outpaced all other branded regimens for HIV treatment, and represented the 22nd quarter of consecutive year over year share gains. For the fourth quarter as highlighted on slide 11.
Moving to slide 10. Our HIV business delivered very strong results for the full year, up 6% year over year to $18.2 billion dollars and contributing almost $1 billion in base business growth, primarily driven by demand as well as higher average realized price due to channel mix and inventory dynamics. More specifically, almost half of the full year HIV growth was driven by higher demand. Most notably by Biktarvy, which delivered solid double-digit year over year growth of 14%, with annualized revenues now more than $12 billion dollars. Already the clear market leader, Biktarvy continues to demonstrate impressive share gains, growing almost 3% year over year in the fourth quarter of 2023 to approximately 48% share in the US. This growth once again outpaced all other branded regimens for HIV treatment, and represented the 22nd quarter of consecutive year over year share gains.
HIV business delivered very strong results for the full year up 6% year over year to $18 $2 billion and could you being almost $1 billion and base business growth, primarily driven by demand as well as higher average realized price due to channel mix and inventory dynamics.
Jackie Ross: Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal.
Speaker Change: Before I hand over to the team for their updates I'll move to slide six and recap that we executed well in 2023 and achieved all of the remaining targeted goals that we expected to in the fourth quarter.
More specifically almost half of the full year HIV growth was driven by higher demand.
Most notably by the Harvey, which delivered solid double digit year over year growth of 14% with annualized revenues now more than $12 billion.
We will share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for gilead I'd like to thank the teams for their work in bringing us to this important catalyst rich phase for the company and for the strong commercial performance that gives US a firm foundation on which to build.
Already the clear market leader HIV continues to demonstrate impressive share gains growing almost 3% year over year in the fourth quarter of 2023 to approximately 48% share in the U S.
Speaker Change: With that I'll hand, it over to Joanna.
This growth once again outpaced all other branded regimens for HIV treatment and represented the 22nd quarter of consecutive year over year share gains.
Thanks, Dan and good afternoon, everyone beginning on slide eight total product sales for the full year at the high end of our guidance range at $26 $9 billion, reflecting solid base business growth. The total products down excluding the quarry at 7% year over year to $24 7 billion.
For the fourth quarter, as highlighted on slide 11, HIV sales of $4.7 billion dollars reflected strong demand in line with our expectations. On a year over year basis, this was offset by lower average realized price due to channel mix. That was notably favorable in the fourth quarter of 2022, and resulted in a decline of 2%. Sequentially, sales were up 1%, similarly driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix. As we've noted previously, the pricing tailwinds as we saw in the second half of 2022 and the first half of 2023 are not expected to repeat, and will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter. As a reminder, quarterly HIV growth is in general significantly more variable and less indicative of overall trends in the full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
For the fourth quarter as highlighted on slide 11.
I think south of $4 $7 billion reflected strong demand in line with our expectations. On a year over year basis. This was offset by lower average realized price due to channel mix that was notably favorable in the fourth quarter of 2022. And resulted in a decline of 2%. Sequentially sales were up 1% similarly, driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix as we've noted previously the pricing tailwind as we saw in the second half of 2022 and the first half of 2023 are not expected to repeat. And we will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter. As a reminder, quarterly HIV growth if in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
On a year over year basis. This was offset by lower average realized price due to channel mix that was notably favorable in the fourth quarter of 2022. And resulted in a decline of 2%. Sequentially sales were up 1% similarly, driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix as we've noted previously the pricing tailwind as we saw in the second half of 2022 and the first half of 2023 are not expected to repeat. And we will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter. As a reminder, quarterly HIV growth if in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
Speaker Change: This was almost entirely offset by the expected decline in February itself.
Speaker Change: For the full year.
Speaker Change: <unk>, south, but $2 $2 billion, reflecting the uptick in hospitalization at the end of 2023 is still below levels seen in 2022.
And resulted in a decline of 2%. Sequentially sales were up 1% similarly, driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix as we've noted previously the pricing tailwind as we saw in the second half of 2022 and the first half of 2023 are not expected to repeat. And we will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter. As a reminder, quarterly HIV growth if in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
Sequentially sales were up 1% similarly, driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix as we've noted previously the pricing tailwind as we saw in the second half of 2022 and the first half of 2023 are not expected to repeat. And we will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter. As a reminder, quarterly HIV growth if in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
Speaker Change: Turning to the fourth quarter on slide nine total product sales were $7 1 billion down 4% year over year, our base business sales were roughly flat year over year at $6 3 billion, primarily driven by higher oncology sales offset by lower HIV sales due to changes in channel mix that resulted in lower average realized.
And we will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter. As a reminder, quarterly HIV growth if in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
As a reminder, quarterly HIV growth if in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
Speaker Change: In addition to the expected decline of our portfolio of non promoted products.
Speaker Change: Moving to slide 10.
Speaker Change: Our HIV business delivered very strong results for the full year up 6% year over year to $18 $2 billion and could you being almost $1 billion and base business growth, primarily driven by demand as well as higher average realized price due to channel mix and inventory dynamics.
Factors include first, gross to net adjustments, which can be difficult to forecast due to the lag between product sales and claim payments that frequently occur in different quarters. Second, the timing of bulk government purchases, which contribute to overall demand, but can have significant negative impact on pricing in the quarter in which they occur. For example, certain discounted government segments are unpredictable in terms of bulk order timing, and this impacts overall average realized price. And then finally, the inventory build by subchannel wholesalers and customers that typically occurs towards the end of the year. Historically this happens in the fourth quarter. In 2023, we saw the build start in the third quarter and continue, albeit to a lesser extent relative to prior years into the fourth quarter. Overall, despite these quarterly variables, we remain confident that overall demand trends are strong and unchanged.
First gross to net adjustments, which can be difficult to forecast due to the lag between product sales and claim payments that frequently occur in different quarters second. The timing of bulk government purchases, which contribute to overall demand, but can have significant negative impact on pricing in the quarter in which they occur. For example, certain discounted government segment are unpredictable in terms of bulk order timing and impacts overall average realized price. And then finally, the inventory built by sub channel wholesalers and customers that typically occurs towards the end of the year. Historically this happens in the fourth quarter in.
The timing of bulk government purchases, which contribute to overall demand, but can have significant negative impact on pricing in the quarter in which they occur. For example, certain discounted government segment are unpredictable in terms of bulk order timing and impacts overall average realized price. And then finally, the inventory built by sub channel wholesalers and customers that typically occurs towards the end of the year. Historically this happens in the fourth quarter in.
Speaker Change: More specifically almost half of the full year HIV growth was driven by higher demand, most notably by the Harvey, which delivered solid double digit year over year growth of 14% with annualized revenues now more than $12 billion.
For example, certain discounted government segment are unpredictable in terms of bulk order timing and impacts overall average realized price. And then finally, the inventory built by sub channel wholesalers and customers that typically occurs towards the end of the year. Historically this happens in the fourth quarter in.
And then finally, the inventory built by sub channel wholesalers and customers that typically occurs towards the end of the year. Historically this happens in the fourth quarter in.
Speaker Change: Already the clear market leader.
Speaker Change: It continues to demonstrate impressive share gains growing almost 3% year over year in the fourth quarter of 2023 to approximately 48% share in the U S.
Historically this happens in the fourth quarter in.
In 2023, we saw the bill to start in the third quarter and continue, albeit to a lesser extent relative to prior years into the fourth quarter.
Speaker Change: This growth once again outpaced all other branded regimens for HIV treatment and represented the 22nd quarter of consecutive year over year starting.
Overall, despite these quarterly variables, we remain confident that overall demand trends are strong and unchanged.
Speaker Change: For the fourth quarter as highlighted on slide 11, HIV south of $4 $7 billion reflected strong demand in line with our expectations.
With our HIV treatment market share above 70% in the US, and above 40% in PrEP, Gilead remains well positioned to continue delivering demand driven growth. For 2024, we expect HIV sales to grow approximately 4%, reflecting annual treatment demand growth of 2% to 3%, Biktarvy market share gain, and continued double digit growth in demand for HIV prevention. In terms of quarterly HIV revenue, keep in mind that the first quarter is always impacted by the reset of patient copays and deductibles. Additionally, we've historically seen inventory buildup in the fourth quarter that has led to notable draw down by wholesalers in the first quarter. In the first quarter of 2023, this contributed to HIV sales declining 12% sequentially, and we expect a similar decline in the 10% to 12% range for the first quarter of 2024. The continued strong performance to both Biktarvy and Descovy for PrEP are shown on slide 12. Overall Gilead leadership in HIV is unmatched. With a solid commercial portfolio and robust pipeline of potentially best in class regimens to serve the daily oral long acting oral and long acting injectable market. And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.
With our HIV treatment market share above 70% in the US, and above 40% in PrEP, Gilead remains well positioned to continue delivering demand driven growth. For 2024, we expect HIV sales to grow approximately 4%, reflecting annual treatment demand growth of 2% to 3%, Biktarvy market share gain, and continued double digit growth in demand for HIV prevention. In terms of quarterly HIV revenue, keep in mind that the first quarter is always impacted by the reset of patient copays and deductibles. Additionally, we've historically seen inventory buildup in the fourth quarter that has led to notable draw down by wholesalers in the first quarter. In the first quarter of 2023, this contributed to HIV sales declining 12% sequentially, and we expect a similar decline in the 10% to 12% range for the first quarter of 2024. The continued strong performance to both Biktarvy and Descovy for PrEP are shown on slide 12. Overall, Gilead's leadership in HIV is unmatched. With a solid commercial portfolio and robust pipeline of potentially best in class regimens to serve the daily oral, long acting oral, and long acting injectable markets. And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.
Speaker Change: On a year over year basis. This was offset by lower average realized price due to channel mix that was notably favorable in the fourth quarter of 2022.
For 2024, we expect HIV sales to grow approximately 4%, reflecting annual treatment demand growth of 2% to 3%.
Speaker Change: It resulted in a decline of 2%.
<unk> market share gains and continued double digit growth in demand for HIV prevention in terms of quarterly HIV revenue keep in mind that the first quarter is always impacted by the reset of patient Copays and deductibles. Additionally, we've historically seen inventory buildup in the fourth quarter that has led to notable draw down by wholesalers in the.
Speaker Change: Sequentially sales were up 1%, primarily driven by strong demand as well as favorable inventory dynamics, partially offset by lower average realized price due to channel mix as we've noted previously the pricing tailwind as we saw in the second half of 2022 and the first half of 2023 are not expected to repeat.
First quarter.
Speaker Change: And we will make year over year comparisons more challenging in the immediate term as we saw in the fourth quarter.
In the first quarter of 2023 this contributed to HIV sales declining 12% sequentially and we expect a similar decline in the 10% to 12% range for the first quarter of 2020 for the continued strong performance to both the Harvey and discovery for prep are shown on slide 12 overall Gilead leadership in HIV is unmatched.
Speaker Change: As a reminder, quarterly HIV growth is in general significantly more variable and less indicative of overall trends in our full year, particularly as certain quarterly pricing and inventory dynamics tend to normalize over the course of the year.
The continued strong performance to both Biktarvy and Descovy for PrEP are shown on slide 12. Overall, Gilead's leadership in HIV is unmatched. With a solid commercial portfolio and robust pipeline of potentially best in class regimens to serve the daily oral, long acting oral, and long acting injectable markets. And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.
Speaker Change: Factors include.
With a solid commercial portfolio and robust pipeline of potentially best in class regimens to serve the daily oral long acting oral and long acting injectable market. And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.
Speaker Change: First gross to net adjustments, which can be difficult to forecast due to the lag between product sales and claim payments that frequently occur in different quarters.
Second the timing of bulk government purchases, which contribute to overall demand, but can have significant negative impact on pricing in the quarter in which they occur.
And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.
Speaker Change: For example, certain discounted government segment are unpredictable in terms of bulk order timing.
Moving to the liver disease portfolio on slide 13, sales of $2.8 billion dollars for the full year highlight the consistently strong and stable contribution from our liver disease portfolio. In the fourth quarter, sales were $691 million dollars, flat year over year and down 2% sequentially, primarily driven by unfavorable pricing dynamics, offset by higher HCV market share and our efforts to increase linkage to care in addition to growing HDV demand in new and existing European geographies. In HCV, we continue to reinforce Gilead's leadership with market share of over 60% in the US and over 50% in Europe. 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.
Speaker Change: Impacts overall average realized price.
Speaker Change: And then finally, the inventory builds by sub channel wholesalers and customers that typically occurs towards the end of the year.
In the fourth quarter sales were $691 million flat year over year and down 2% sequentially, primarily driven by unfavorable pricing dynamics.
Speaker Change: Historically this happens in the fourth quarter in.
Speaker Change: In 2023, we thought the bill start in the third quarter and continue, albeit to a lesser extent relative to prior years into the fourth quarter.
Offset by higher HCV market share and our efforts to increase linkage to care. In addition to growing HEV demand in new and existing European geographies in HCV, we continue to reinforce gilead leadership with market share of over 60% in the U S and over 50% in Europe.
Speaker Change: Overall, despite these quarterly variables, we remain confident that overall demand trends are strong and unchanged.
Speaker Change: With our HIV treatment market share above 70% in the U S and about 40% in prep Gilead remains well positioned to continue delivering demand driven growth.
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 HDD and HBV is largely offsetting that headwind.
Speaker Change: For 2024, we expect HIV sales to grow approximately 4%, reflecting annual treatment demand growth of 2% to 3%.
<unk> market share gains and continued double digit growth in demand for HIV prevention in terms of quarterly HIV revenue keep in mind that the first quarter is always impacted by the reset of patient Copays and deductibles. Additionally, we've historically seen inventory buildup in the fourth quarter that has led to notable draw down by wholesalers in the.
Onto slide 14. Veklury sales continue to be highly variable, with the fourth quarter down 28% year over year, though up 13% sequentially due to higher COVID-19 related hospitalizations in the fourth quarter. For the full year, Veklury sales of $2.2 billion dollars exceeded the expectations we set out at the beginning of 2023.
<unk> sales continue to be highly variable with the fourth quarter down 28% year over year, they were up 13% sequentially due to higher COVID-19 related hospitalizations in the fourth quarter.
For the full year <unk> sales of $2 2 billion exceeded the expectations, we set out at the beginning of 2023.
Speaker Change: First quarter.
Speaker Change: In the first quarter of 2023 this contributed to HIV sales declining 12% sequentially and we expect a similar decline in the 10% to 12% range for the first quarter of 2020 for the continued strong performance to both the Harvey and discovery for prep are shown on slide 12 overall Gilead leadership in HIV is unmatched.
Turning to slide 15. Our oncology business has achieved an annualized run rate that now exceeds $3 billion dollars, with strong fourth quarter sales of $765 million, up 24% year over year. In just three years, Trodelvy revenue has grown to more than $1 billion dollars, and we continue to see strong growth across our approved indication. And in cell therapy, sales approached $2 billion dollars in 2023, and Kite remains firmly established as the leading provider of CAR T-cell therapies globally.
Our oncology business has achieved an annualized run rate that now exceeds $3 billion with strong fourth quarter sales of 765 million up 24% year over year.
In just three years to Dolby revenue has grown to more than $1 billion and we continue to see strong growth across our approved indication and.
Speaker Change: With a solid commercial portfolio and robust pipeline of potentially best in class regimens to serve the daily oral long acting oral and long acting injectable market.
And in cell therapy sales approached $2 billion in 2023, and kite remains firmly established as the leading provider of car T cell therapies globally.
Speaker Change: And I can share we are off to a strong start in terms of HIV demand, which gives us confidence in our full year expectations for 2024.
Looking more closely at Trodelvy on slide 16. Sales for the full year were $1.1 billion dollars, up 56% year over year. For the fourth quarter, sales were $299 million, up 53% year over year and 5% sequentially. With over 30,000 patients treated to date, Trodelvy's solid demand trends continue to reinforce its robust clinical profile as the only TROP2-directed antibody drug conjugate approved and available in multiple tumor types. Awareness and utilization continued to increase, driving notable share gains. In second line metastatic triple negative breast cancer, approximately one third of patients are receiving Trodelvy, reinforcing its position as the leading regimen across the US and other major markets. In pretreated HR-positive HER2-negative metastatic breast cancer, we're encouraged to see share growth overall, driven by increasing adoption in the IHC-0 setting, as well as continued use and HER2 low. Additionally, we look forward to potentially making Trodelvy more broadly available in metastatic bladder cancer. Data from the confirmatory Phase III Tropics-04 study in the first half of the year would enable global filings and subsequent launches, as well as potentially drive adoption in the US. Altogether expanding to Trodelvy's potential reach to nearly 25,000 second line plus patients with metastatic bladder cancer.
For the full year were $1 1 billion up 56% year over year.
Speaker Change: Moving to the liver disease portfolio on slide 13 sales of $2 $8 billion for the full year highlight the consistently strong and stable contribution from our liver disease portfolio.
For the fourth quarter sales were $299 million up 53% year over year and 5% sequentially.
With over 30000 patients treated to date to Dolby solid demand trends continue to reinforce its robust clinical profile as the only truck to directed antibody drug conjugate.
Speaker Change: In the fourth quarter sales were $691 million flat year over year and down 2% sequentially.
Speaker Change: Really driven by unfavorable pricing dynamics.
Speaker Change: Offset by higher HCV market share and our efforts to increase linkage to care.
<unk> and available in multiple tumor types.
Awareness and utilization continued to increase driving notable share gains.
Speaker Change: In addition to growing HEV demand in new and existing European geographies in HCV, we continue to reinforce gilead leadership with market share of over 60% in the U S and over 50% in Europe.
In second line metastatic triple negative breast cancer, approximately one third of patients are receiving to Dolby reinforcing its position as the leading regimen across the U S and other major markets. In pretreated HR positive <unk> negative metastatic breast cancer, we're encouraged to see share growth overall, driven by increasing adoption in the IHT zero setting as well as continue to use and her too though. Additionally, we look forward to potentially making <unk> more broadly available in metastatic bladder cancer. Data from the confirmatory phase III tropics <unk> study in the first half of the year, but enable global filings and subsequent launches as. As well as potentially drive adoption in the U S. Altogether expanding to debbie's potential reached nearly 25002nd line plus patients with metastatic bladder cancer.
Speaker Change: While we continue to expect the rate of HDD, new starts to trend downwards over time, given the curative nature of our medicines demand growth in both HDD and HBV is largely offsetting that headwind.
In pretreated HR positive <unk> negative metastatic breast cancer, we're encouraged to see share growth overall, driven by increasing adoption in the IHT zero setting as well as continue to use and her too though. Additionally, we look forward to potentially making <unk> more broadly available in metastatic bladder cancer. Data from the confirmatory phase III tropics <unk> study in the first half of the year, but enable global filings and subsequent launches as. As well as potentially drive adoption in the U S. Altogether expanding to debbie's potential reached nearly 25002nd line plus patients with metastatic bladder cancer.
Speaker Change: On to slide 14.
Speaker Change: <unk> sales continue to be highly variable with the fourth quarter down 28% year over year up 13% sequentially due to higher COVID-19 related hospitalizations in the fourth quarter.
Additionally, we look forward to potentially making <unk> more broadly available in metastatic bladder cancer. Data from the confirmatory phase III tropics <unk> study in the first half of the year, but enable global filings and subsequent launches as. As well as potentially drive adoption in the U S. Altogether expanding to debbie's potential reached nearly 25002nd line plus patients with metastatic bladder cancer.
Data from the confirmatory phase III tropics <unk> study in the first half of the year, but enable global filings and subsequent launches as. As well as potentially drive adoption in the U S. Altogether expanding to debbie's potential reached nearly 25002nd line plus patients with metastatic bladder cancer.
Speaker Change: For the full year <unk> sales of $2 2 billion exceeded the expectations, we set out at the beginning of 2023.
As well as potentially drive adoption in the U S. Altogether expanding to debbie's potential reached nearly 25002nd line plus patients with metastatic bladder cancer.
Altogether expanding to debbie's potential reached nearly 25002nd line plus patients with metastatic bladder cancer.
Speaker Change: Turning to slide 15.
Speaker Change: Our oncology business has achieved an annualized run rate that now exceeds $3 billion with strong fourth quarter sales of $765 million up 24% year over year.
Turning to slide 17, and on behalf of Cindy and the Kite team, cell therapy sales were $1.9 billion dollars in 2023, grew 28% from 2022, driven by impressive growth, particularly outside the US as we expanded our network of authorized treatment centers and secured reimbursement following recent approvals. In the fourth quarter, cell therapy product sales were $466 million dollars, up 11% year over year, and down 4% sequentially with strong growth in both Yescarta and Tecartus in Europe and other international markets, offset in part by near term headwinds for Yescarta in the US, both in class and out of class competition. As previously discussed, CAR T class share of eligible second line plus large B-cell lymphoma patients remains at roughly 15% in the US as growth continues to be slower than anticipated, despite the compelling clinical data that suggest these therapies are potentially transformative for many patients. In Europe and other markets, CAR T Cross share in the same second line plus setting continues to be stronger at approximately 30%.
Speaker Change: In just three years <unk> revenue has grown to more than $1 billion and we continue to see strong growth across our approved indication.
Speaker Change: And in cell therapy sales approach $2 billion in 2023 and tight remains firmly established as the leading provider of car T cell therapies globally.
In the fourth quarter cell therapy product sales were $466 million up 11% year over year and down 4% sequentially with strong growth in both just garden took artist in Europe, and other international markets offset in part by near term headwinds forget Garda in the U S. Both in class and out of class competition.
Looking more closely at <unk> on slide 16.
Speaker Change: Sales for the full year were $1 1 billion at 56% year over year.
Speaker Change: For the fourth quarter sales were $299 million at 53% year over year and 5% sequentially.
As previously discussed car T class share of eligible second line plus large b cell lymphoma patients remains at roughly 15% in the U S. As growth continues to be slower than anticipated. Despite the compelling clinical data that suggest these therapies are potentially transformative for many patients.
Speaker Change: With over 30000 patients treated to date to Dolby solid demand trends continue to reinforce its robust clinical profile as the only trop two directed antibody drug conjugate approved and available in multiple tumor types.
Speaker Change: Awareness and utilization continued to increase driving notable share gains.
And Europe and other markets car T Cross share in the same second line plus setting continues to be stronger at approximately 30%.
Speaker Change: In second line metastatic triple negative breast cancer, approximately one third of patients RBC to Dolby reinforcing its position as the leading regimen across the U S and other major markets.
Following a restructuring in November, the Kite team has been focused on extending the reach of cell therapies from primarily academic medical centers to community practices, especially in the US. In late 2023, we established partnerships with leading community networks, which include over 1,750 physicians nationally. We are certifying affiliated practices to become authorized treatment centers to provide Kite cell therapies. So far we've made notable headway across centers in the southeast United States, for example, that operate over 40 locations to serve cancer patients. We expect to see the initial impact of these initiatives in mid-2024. In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024, compared to the fourth quarter of 2023. Importantly, alongside our 96% reliability rate, we're also thrilled to share that we have shortened our manufacturing time in the US by two days for Yescarta, bringing our anticipated median turnaround time to 14 days. This further extends our industry leadership in terms of manufacturing, and the Kite team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
In pretreated HR positive <unk> negative metastatic breast cancer, we're encouraged to see share growth overall, driven by increasing adoption in the IFC zero setting as well as continue to use and her too low.
In late 2023, we established partnerships with leading community networks, which include over 750 physicians nationally.
Speaker Change: Additionally, we look forward to potentially making shall be more broadly available in metastatic bladder cancer.
We are certifying affiliated practices to become authorized treatment centers to provide kite cell therapies. So far we've made notable headway across centers in the southeast United States. For example that operate over 40 locations to serve cancer patients. We expect to see the initial impact of these initiatives in mid 2024 and. In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023 importantly, alongside our 96% reliability rate. We're also thrilled to share that we have shortened our manufacturing time in the U S. By two days forgets Garda, bringing our anticipated median Turner. Round time to 14 days. This further extend our industry leadership in terms of manufacturing and the kite team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
Speaker Change: Data from the confirmatory phase III tropics <unk> study in the first half of the year, but enable global filings and subsequent launches as.
So far we've made notable headway across centers in the southeast United States. For example that operate over 40 locations to serve cancer patients. We expect to see the initial impact of these initiatives in mid 2024 and. In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023 importantly, alongside our 96% reliability rate. We're also thrilled to share that we have shortened our manufacturing time in the U S. By two days forgets Garda, bringing our anticipated median Turner. Round time to 14 days. This further extend our industry leadership in terms of manufacturing and the kite team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
Speaker Change: As well as potentially drive adoption in the U S.
Speaker Change: Altogether expanding to these potential reach to nearly 25002nd line patients with metastatic bladder cancer.
We expect to see the initial impact of these initiatives in mid 2024 and. In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023 importantly, alongside our 96% reliability rate. We're also thrilled to share that we have shortened our manufacturing time in the U S. By two days forgets Garda, bringing our anticipated median Turner. Round time to 14 days. This further extend our industry leadership in terms of manufacturing and the kite team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023 importantly, alongside our 96% reliability rate. We're also thrilled to share that we have shortened our manufacturing time in the U S. By two days forgets Garda, bringing our anticipated median Turner. Round time to 14 days. This further extend our industry leadership in terms of manufacturing and the kite team continues to innovate in this critical element of the cell therapy business. We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
Speaker Change: Turning to slide 17, and on behalf of Cindy and the team.
Speaker Change: Cell therapy sales were $1 9 billion in 2023 grew 28% from 2022, driven by impressive growth, particularly outside the U S. As we expanded our network of authorized treatment centers and secured reimbursement following recent approvals.
Round time to 14 days.
Speaker Change: In the fourth quarter cell therapy product sales were $466 million up 11% year over year and down 4% sequentially with strong growth in both just got into Curtis in Europe, and other international markets offset in part by near term headwinds forget Garda in the U S. Both in class and out of competition.
This further extend our industry leadership in terms of manufacturing and the kite team continues to innovate in this critical element of the cell therapy business.
We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
In conclusion I'd like to thank our teams for a strong 2023 performance and setting up such great momentum for continued growth in 2024. The team's excited to continue to make our medicines accessible to all those who can benefit from them. And with that, I'll hand over the call to Merdad.
Speaker Change: As previously discussed car T class share of eligible second line plus large b cell lymphoma patients remains at roughly 15% in the U S. As growth continues to be slower than anticipated. Despite the compelling clinical data that suggest these therapies are potentially transformative for many patients.
The team is excited to continue to make our medicines accessible to all those who can benefit from them. And with that I'll hand over the call to Murdoch.
And with that I'll hand over the call to Murdoch.
Merdad V. Parsey: Thank you, Johanna. We've had a busy start to 2024, and I'll begin by discussing the results of our EVOKE-01 study in second line plus metastatic non small cell lung cancer, and our Phase III Oaktree study of Obeldesevir in standard risk non hospitalized patients with COVID-19. While we were disappointed that these studies did not meet their primary endpoints, we're also encouraged by what we're learning from the data to inform our clinical programs and support our commitment to deliver innovative new therapies for patients. Let me cover each of these readouts in turn.
We've had a busy start to 2024 and I'll begin by discussing the results of our vocal one study in second line plus metastatic non small cell lung cancer and our phase III Oaktree study of although that severe and standard risk non hospitalized patients with COVID-19.
Speaker Change: And Europe and other markets car T cost share in the same second line plus setting continues to be stronger at approximately 30%.
Speaker Change: Following our restructuring in November the kite team has been focused on extending the reach of cell therapies from primarily academic medical centers to community practices, especially in the U S.
While we were disappointed that these studies did not meet their primary endpoints were also encouraged by what we're learning from the data to inform our clinical programs and support our commitment to deliver innovative new therapies for patients let.
Speaker Change: In late 2023, we established partnerships with leading community networks, which include over 1750 physicians nationally.
Let me cover each of these readouts in term.
First on slide 19, our phase III study of <unk> in second line plus metastatic non small cell lung cancer they'll go one missed its primary endpoint of overall survival in this hard to treat setting. Plan to share the detailed data at the earliest opportunity in the meantime, we'd like to highlight what we believe to be an important set of observations from Yoko one they give us continued confidence in <unk> as a pipeline in a product and its potential to benefit some patients with lung cancer. We saw numerical improvement favoring <unk>, including in patients with both squamous and non squamous histology. This is encouraging for our ongoing phase III <unk> III first line trial evaluating <unk> in PD Lone high patients in combination with <unk>. Importantly to Adobe continues to demonstrate a potentially differentiated safety efficacy and tolerability profile within the adverse event profile that is consistent with our label. Further to Adobe achieved more than three months of improvement in median overall survival in a pre specified subgroup of patients nonresponsive to their prior anti PD one therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population. This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
First, on slide 19, our Phase III study of Trodelvy in second line plus metastatic non small cell lung cancer, EVOKE-01, missed its primary endpoint of overall survival in this hard to treat setting. We plan to share the detailed data at the earliest opportunity. In the meantime, we'd like to highlight what we believe to be an important set of observations from EVOKE-01 that give us continued confidence in Trodelvy as a pipeline and a product, and its potential to benefit some patients with lung cancer. We saw numerical improvement favoring Trodelvy, including in patients with both squamous and non squamous histologies. This is encouraging for our ongoing Phase III EVOKE-03 first line trial, evaluating Trodelvy in PD-L1 high patients in combination with pembrolizumab. Importantly, Trodelvy continues to demonstrate a potentially differentiated safety, efficacy, and tolerability profile, with an adverse event profile that is consistent with our label. Further, Trodelvy achieved more than three months of improvement in median overall survival in a pre-specified subgroup of patients, nonresponsive to their prior anti-PD-L1 therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior IO therapy and represented more than 60% of the trial population.
Speaker Change: We are certifying affiliated practices to become authorized treatment centers to provide kite cell therapies.
Speaker Change: So far we've made notable headway across centers in the south Eastern United States. For example that operate over 40 locations to serve cancer patients.
Plan to share the detailed data at the earliest opportunity in the meantime, we'd like to highlight what we believe to be an important set of observations from Yoko one they give us continued confidence in <unk> as a pipeline in a product and its potential to benefit some patients with lung cancer.
Speaker Change: We expect to see the initial impact of these initiatives in mid 2024 and.
Speaker Change: In the meantime, we expect our cell therapy business to be flat to slightly up in the first quarter of 2024 compared to the fourth quarter of 2023 importantly, alongside our 96% reliability rate. We're also thrilled to share that we have shortened our manufacturing time in the U S. By two days for yes, Garda, bringing our anticipated median Turner.
We saw numerical improvement favoring <unk>, including in patients with both squamous and non squamous histology. This is encouraging for our ongoing phase III <unk> III first line trial evaluating <unk> in PD Lone high patients in combination with <unk>. Importantly to Adobe continues to demonstrate a potentially differentiated safety efficacy and tolerability profile within the adverse event profile that is consistent with our label. Further to Adobe achieved more than three months of improvement in median overall survival in a pre specified subgroup of patients nonresponsive to their prior anti PD one therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population. This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
This is encouraging for our ongoing phase III <unk> III first line trial evaluating <unk> in PD Lone high patients in combination with <unk>. Importantly to Adobe continues to demonstrate a potentially differentiated safety efficacy and tolerability profile within the adverse event profile that is consistent with our label. Further to Adobe achieved more than three months of improvement in median overall survival in a pre specified subgroup of patients nonresponsive to their prior anti PD one therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population. This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Around time to 14 days.
Importantly to Adobe continues to demonstrate a potentially differentiated safety efficacy and tolerability profile within the adverse event profile that is consistent with our label. Further to Adobe achieved more than three months of improvement in median overall survival in a pre specified subgroup of patients nonresponsive to their prior anti PD one therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population. This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: This further extend our industry leadership in terms of manufacturing and the <unk> team continues to innovate in this critical element of the cell therapy business.
Speaker Change: We look forward to inviting you to visit one of our manufacturing facilities later this quarter during an analyst and investor event.
Further to Adobe achieved more than three months of improvement in median overall survival in a pre specified subgroup of patients nonresponsive to their prior anti PD one therapy. This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population. This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: In conclusion I'd like to thank our teams for a strong 2023 performance and setting up such great momentum for continued growth in 2020 for the.
This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population. This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: The team is excited to continue to make our medicines accessible to all those who can benefit from them.
Speaker Change: And with that I'll hand over the call to <unk>.
This analysis was not alpha controlled for formal statistical testing, and we are continuing to analyze these data. We will discuss these data with regulators and KOLs to determine the best path forward. As a reminder, we required all patients to have received prior IO therapy, regardless of driver mutation status, and responsiveness to prior IO was a stratification factor. Additional analyses, including TROP2 expression, are ongoing and we will share these data as quickly as possible. Based on these observations and the data from the ongoing EVOKE-02 study, we remain confident in Trodelvy's potential in patients with metastatic non small cell lung cancer. For now, given these findings we currently do not plan changes to our Phase III EVOKE-03 study, that's enrolling as expected.
This analysis does not alpha controlled for formal statistical testing and we are continuing to analyze these data we will discuss these data with regulators and kols to determine the best path forward. As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: Thank you Joanna we've.
Speaker Change: <unk> had a busy start to 2024 and I'll begin by discussing the results of our <unk>. One study in second line plus metastatic non small cell lung cancer and our phase III Oaktree study, although the severe and standard risk non hospitalized patients with COVID-19.
As a reminder, we required all patients to have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor. Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: While we were disappointed that these studies did not meet their primary endpoints were also encouraged by what we are learning from the data to inform our clinical programs and support our commitment to deliver innovative new therapies for patients.
Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing a bogo two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer. For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: Me cover each of these readouts in term.
Speaker Change: First on slide 19, our phase III study of <unk> in second line plus metastatic non small cell lung cancer. We'll go one missed its primary endpoint of overall survival in this hard to treat settings.
For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: We plan to share the detailed data at the earliest opportunity in the meantime, we'd like to highlight what we believe to be an important set of observations from Yoko one they give us continued confidence in <unk> as a pipeline in a product and its potential to benefit some patients with lung cancer.
Moving to slide 20, our novel twice daily oral antiviral Obeldesevir did not demonstrate a statistically significant symptom relief in standard risk, non hospitalized patients with COVID-19 in our Phase III Oaktree trial. Obeldesevir was well tolerated in this large study population, and we will share the data at a future medical meeting. Overall, the Oaktree results reflect a decrease in severity and duration of COVID-19 symptoms observed in standard risk patients. Driven by the evolution of variance and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated standard risk patients is now less than a week, as compared to almost two weeks at the peak of the pandemic. As a result, it was challenging for Obeldesevir to show a benefit in the standard risk population. We continue to assess whether Obeldesevir could address other viral infections, given the broad antiviral activity that we have observed in preclinical data.
<unk> was well tolerated in this large study population and we will share the data at a future medical meeting. Overall, the Oaktree results reflect a decrease in severity and duration of COVID-19 symptoms observed in standard risk patients. Driven by the evolution of variance and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated standard risk patients is now less than a week as compared to almost two weeks at the peak of the pandemic as a result, it was challenging for other less severe to show a benefit in the standard risk population. We continue to assess whether <unk> could address other viral infections given the broad antiviral activity that we have observed in preclinical data.
Speaker Change: We saw numerical improvement favoring to adobe, including in patients with both squamous and non squamous histology. This.
Overall, the Oaktree results reflect a decrease in severity and duration of COVID-19 symptoms observed in standard risk patients. Driven by the evolution of variance and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated standard risk patients is now less than a week as compared to almost two weeks at the peak of the pandemic as a result, it was challenging for other less severe to show a benefit in the standard risk population. We continue to assess whether <unk> could address other viral infections given the broad antiviral activity that we have observed in preclinical data.
Speaker Change: This is encouraging for our ongoing phase III <unk> III first line trial evaluating <unk> in PD Lone high patients in combination with <unk>.
Driven by the evolution of variance and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated standard risk patients is now less than a week as compared to almost two weeks at the peak of the pandemic as a result, it was challenging for other less severe to show a benefit in the standard risk population. We continue to assess whether <unk> could address other viral infections given the broad antiviral activity that we have observed in preclinical data.
Speaker Change: Importantly to Adobe continues to demonstrate a potentially differentiated safety efficacy and tolerability profile within the adverse event profile that is consistent with our label.
The time to symptom alleviation in untreated standard risk patients is now less than a week as compared to almost two weeks at the peak of the pandemic as a result, it was challenging for other less severe to show a benefit in the standard risk population. We continue to assess whether <unk> could address other viral infections given the broad antiviral activity that we have observed in preclinical data.
Speaker Change: Further to Adobe achieved more than three months of improvement in median overall survival in a pre specified subgroup of patients nonresponsive to their prior anti PD one therapy.
We continue to assess whether <unk> could address other viral infections given the broad antiviral activity that we have observed in preclinical data.
Speaker Change: This subgroup is defined as those who achieved stable disease or progressive disease as their best outcome to last prior I O therapy and represented more than 60% of the trial population.
Moving to another clinical update in oncology, the Phase III ENHANCE-3 trial evaluating Magrolimab in frontline unfit AML has been discontinued based on a futility analysis and a higher observed incidence of grade five serious adverse events. Following the discontinuation of ENHANCE and ENHANCE-2 last year, we do not plan further development of Magrolimab in hematologic cancers. Wrapping up on clinical updates, I want to thank all of those who are involved with EVOKE-01, Oaktree, and ENHANCE-3. Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans. We look forward to sharing more on that in due course.
Speaker Change: This analysis does not offer controle to form a statistical testing and we are continuing to analyze these data we.
Speaker Change: We will discuss these data with regulators and kols to determine the best path forward.
Following the discontinuation of enhanced and enhanced to last year, we do not plan further development of <unk> in hematologic cancers. Giving up on clinical updates I want to thank all of those who are involved with the Boca won oaktree and enhanced III. Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans. We look forward to sharing more on that in due course.
Speaker Change: As a reminder, we required all patients who have received prior I O therapy, regardless of driver mutation status and responsiveness to prior I O was a stratification factor.
Giving up on clinical updates I want to thank all of those who are involved with the Boca won oaktree and enhanced III. Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans. We look forward to sharing more on that in due course.
Speaker Change: Additional analyses, including Trop two expression are ongoing and we will share. These data as quickly as possible based on these observations in the data from the ongoing Bogo. Two study we remain confident in <unk> potential in patients with metastatic non small cell lung cancer.
Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans. We look forward to sharing more on that in due course.
We look forward to sharing more on that in due course.
Transitioning to our HIV program on slide 21, we expect the Phase III readout of PURPOSE-1, evaluating Lenacapavir for HIV prevention later this year. Along with PURPOSE-2, expected in late 2024 or early 2025, PURPOSE-1 forms the basis of our potential regulatory filing. We continue to target our first approval for Lenacapavir in prevention in late 2025, potentially making Lenacapavir the first twice-yearly dosing regimen available for PrEP. Looking at our HIV program more broadly, you can see we will be sharing at least nine updates this year across our next generation daily, weekly, three-monthly, and twice-yearly programs, all based on Lenacapavir, our novel, first in class, long acting capsid inhibitor. We're excited to have over 75 presentations at CROI this year across Gilead led and supported studies. Among them, some notable updates from our treatment pipeline include: encouraging data from our Phase II ARTISTRY-1 trial evaluating our Lenacapavir and Bictegravir once daily oral. We're exploring this combination as a potential additional option for biologically suppressed people living with HIV. Phase I data on GS-1720, our once weekly oral integrase inhibitor, and Phase II data on Lenacapavir plus Islatravir, our once weekly oral combination in development with Merck. In the second half of this year, we look forward to providing an update on the Phase II trial evaluating Lenacapavir plus bNAbs as a twice yearly regimen.
Speaker Change: For now given these findings we currently do not plan changes to our phase III <unk> III study, that's enrolling as expected.
Speaker Change: Moving to slide 20, our novel twice daily oral antiviral <unk> did not demonstrate a statistically significant symptom relief in standard risk non hospitalized patients with COVID-19, and our phase III <unk> trial.
Target, our first approval for Atlantic cap of ear and prevention in late 2025, potentially making Linda Copyread. The first twice yearly dosing regimen available for prep. Looking at our HIV program more broadly you can see we will be sharing at least nine updates this year across our next generation Daily weekly three monthly and twice yearly programs all based on <unk>. Our novel first in class long acting capsid inhibitor. We're excited to have over 75 presentations at Croix this year across Gilead led and supported studies. Among them. Some notable updates from our treatment pipeline include encouraging data from our phase two artistry, one trial evaluating Atlantic <unk> once daily oral. We're exploring this combination is a potential additional option for biologically suppressed people living with HIV. Phase one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as it. Twice yearly regimen <unk>.
Speaker Change: <unk> was well tolerated in this large study population and we will share the data at a future medical meeting.
Looking at our HIV program more broadly you can see we will be sharing at least nine updates this year across our next generation Daily weekly three monthly and twice yearly programs all based on <unk>. Our novel first in class long acting capsid inhibitor. We're excited to have over 75 presentations at Croix this year across Gilead led and supported studies. Among them. Some notable updates from our treatment pipeline include encouraging data from our phase two artistry, one trial evaluating Atlantic <unk> once daily oral. We're exploring this combination is a potential additional option for biologically suppressed people living with HIV. Phase one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as it. Twice yearly regimen <unk>.
Speaker Change: Overall, the <unk> results reflect a decrease in severity and duration of COVID-19 symptoms observed in standard risk patients driven by the evolution of variance and improved immunity to COVID-19 in our trial population.
We're excited to have over 75 presentations at Croix this year across Gilead led and supported studies. Among them. Some notable updates from our treatment pipeline include encouraging data from our phase two artistry, one trial evaluating Atlantic <unk> once daily oral. We're exploring this combination is a potential additional option for biologically suppressed people living with HIV. Phase one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as it. Twice yearly regimen <unk>.
Speaker Change: The time to symptom alleviation in untreated standard risk patients is now less than a week as compared to almost two weeks at the peak of the pandemic as a result, it was challenging for <unk> to show a benefit in the standard risk population.
Among them. Some notable updates from our treatment pipeline include encouraging data from our phase two artistry, one trial evaluating Atlantic <unk> once daily oral. We're exploring this combination is a potential additional option for biologically suppressed people living with HIV. Phase one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as it. Twice yearly regimen <unk>.
Speaker Change: We continue to assess whether although that severe could address other viral infections given the broad antiviral activity that we've observed in preclinical data.
We're exploring this combination is a potential additional option for biologically suppressed people living with HIV. Phase one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as it. Twice yearly regimen <unk>.
Phase one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as it. Twice yearly regimen <unk>.
Speaker Change: Moving to another clinical update in oncology the phase III enhance three trial evaluating <unk> in frontline unfit AML has been discontinued based on a futility analysis and a higher observed incidence of grade five serious adverse events.
Speaker Change: Following the discontinuation of enhanced and enhanced to last year, we do not plan further development of <unk> in hematologic cancers wrapped.
Twice yearly regimen <unk>.
Turning to cell therapy on slide 22, you may have seen that the FDA recently proposed safety label changes for all approved CV-19, and BCMA CAR T cell therapies, including Yescarta and Tecartus. There is no change to our confidence in the benefit-risk profile of Yescarta and Tecartus. Based on analysis of our global safety database, with over 16,800 patients treated with Yescarta, there has been no causal link established between Yescarta and those reported to the FDA public safety dashboard. Additionally, no cases of T cell malignancies have been reported with Tecartus. In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December, showing that Yescarta and Tecartus continue to generate some of the longest follow up and most robust datasets for cell therapies with the potential to transform patient lives. Also at ASH, our partner Arcellx presented impressive updated data from the Phase I trial evaluating Anito-cel in 38 patients with relapsed or refractory multiple myeloma. At a median follow up of 26.5 months, median progression-free survival was not yet reached, despite 70% of patients, having one or more high risk prognosis factors. Given this potentially differentiated safety profile, with notably no delayed neurotoxicity date, including Parkinsonism, Anito-cel has the potential to become the best in class BCMA CAR-T. We look forward to sharing an update from the pivotal Phase II iMMagine-1 study and initiating an earlier-line multiple myeloma trial later this year.
Speaker Change: Wrapping up on clinical updates I want to thank all of those who are involved with the bogo, one oaktree and enhanced III.
Speaker Change: Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans.
There is no change to our confidence and the benefit risk profile of your <unk> and to Carter's. Based on analysis of our global safety database with over 16800 patients treated with just Garda Theres been no causal link established between yes, Garda and those reported to the FDA public safety dashboard. Additionally, no cases of T cell malignancies have been reported with <unk>. In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December showing that <unk> has continued to generate some of the longest follow up and most robust datasets for cell therapies with the potential to transform patient lives also at ash, our partner arched Alex presented impressive updated. Data from the phase one trial evaluating <unk> in 38 patients with relapsed or refractory multiple myeloma. At a median follow up of $26 five months median progression free survival was not yet reached despite 70% of patients, having one or more high risk prognosis factors. Given this potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class the CMA car T. We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Speaker Change: We look forward to sharing more on that in due course.
Based on analysis of our global safety database with over 16800 patients treated with just Garda Theres been no causal link established between yes, Garda and those reported to the FDA public safety dashboard. Additionally, no cases of T cell malignancies have been reported with <unk>. In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December showing that <unk> has continued to generate some of the longest follow up and most robust datasets for cell therapies with the potential to transform patient lives also at ash, our partner arched Alex presented impressive updated. Data from the phase one trial evaluating <unk> in 38 patients with relapsed or refractory multiple myeloma. At a median follow up of $26 five months median progression free survival was not yet reached despite 70% of patients, having one or more high risk prognosis factors. Given this potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class the CMA car T. We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Speaker Change: Transitioning to our HIV program on Slide 21, we expect the phase III readout of purpose, one evaluating <unk> for HIV prevention later this year along with purpose to expected in late 2024 or early 2025 purpose one forms the basis of our potential regulatory filings we continue to.
In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December showing that <unk> has continued to generate some of the longest follow up and most robust datasets for cell therapies with the potential to transform patient lives also at ash, our partner arched Alex presented impressive updated. Data from the phase one trial evaluating <unk> in 38 patients with relapsed or refractory multiple myeloma. At a median follow up of $26 five months median progression free survival was not yet reached despite 70% of patients, having one or more high risk prognosis factors. Given this potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class the CMA car T. We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Target our first approval for <unk> in prevention in late 2025, potentially making <unk>. The first twice yearly dosing regimen available for prep.
Speaker Change: Looking at our HIV program more broadly you can see we will be sharing at least nine update this year across our next generation Daily weekly three monthly and twice yearly programs all based on <unk>. Our novel first in class long acting capsid inhibitor.
Data from the phase one trial evaluating <unk> in 38 patients with relapsed or refractory multiple myeloma. At a median follow up of $26 five months median progression free survival was not yet reached despite 70% of patients, having one or more high risk prognosis factors. Given this potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class the CMA car T. We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
At a median follow up of $26 five months median progression free survival was not yet reached despite 70% of patients, having one or more high risk prognosis factors. Given this potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class the CMA car T. We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Speaker Change: We're excited to have over 75 presentations that Cory this year across Gilead led and supported studies.
Speaker Change: Among them. Some notable updates from our treatment pipeline include encouraging data from our phase II artistry, one trial evaluating our Atlantic <unk> once daily oral.
Given this potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class the CMA car T. We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Speaker Change: We're exploring this combination is a potential additional option for biologically suppressed people living with HIV.
We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Speaker Change: As one data on <unk> 'twenty, our once weekly oral integrates inhibitor and phase II data on <unk>, plus <unk> or once weekly oral combination in development with Merck in the second half of this year, we look forward to providing an update on the phase III trial evaluating <unk> plus <unk> as a toy.
In terms of manufacturing, while Kite is already the clear leader, we're pleased to highlight that the FDA approved our updated process that reduces the turnaround time for Yescarta in the US from 16 days down to 14 days. This further extends our leadership in cell therapy, and we continue to identify additional opportunities to reliably bring these much needed therapies to more patients as quickly as possible. Beyond manufacturing, we have eight ongoing cell therapy trials, of which four are evaluating new indications, and four are exploring earlier lines of therapy.
This further extends our leadership in cell therapy, and we continue to identify additional opportunities to reliably bring these much needed therapies to more patients as quickly as possible. Beyond manufacturing. Ongoing cell therapy trials of which four are evaluating new indications and four are exploring earlier lines of therapy.
Speaker Change: Securely regimen.
Speaker Change: Turning to cell therapy on slide 22, you may have seen that the FDA recently proposed safety label changes for all approved <unk> 19, and <unk> car T cell therapies, including <unk> and <unk>.
Beyond manufacturing. Ongoing cell therapy trials of which four are evaluating new indications and four are exploring earlier lines of therapy.
Ongoing cell therapy trials of which four are evaluating new indications and four are exploring earlier lines of therapy.
Speaker Change: There is no change to our confidence and the benefit risk profile of <unk> and to Carter's.
As we formally wrap up 2023 on slide 23, I would like to acknowledge the work of our clinical teams, who executed on our ambitious and broad portfolio that extends far beyond the lists shown, including the advancement of eight new assets into the clinic, the delivery of 15 late breaking oral presentations at major clinical congresses, and the initiation of three new Phase III programs. For 2024 our target milestones laid out on slide 24 include an update on ASCENT-03 in first line PD-L1 negative metastatic triple negative breast cancer, an update on TROPICS-04, assessing overall survival in second line metastatic or locally advanced bladder cancer, and an update on our Phase III PURPOSE-1 trial, assessing Lenacapavir in HIV prevention, as previously highlighted. We are also looking forward to the start of Phase III trials for Trodelvy in endometrial cancer, and the ARTISTRY trials evaluating Lenacapavir and Bictegravir oral combination for HIV treatment. Our commitment to develop innovative new therapeutic options is unchanged, and we are confident that we will make progress on that commitment in 2024. And now I'll hand the call over to Andy.
Speaker Change: Based on analysis of our global safety database with over 16800 patients treated with just startup theres been no causal link established between yes, Garda and those reported to the FDA public safety dashboard. Additionally, no cases of T cell malignancies have been reported with <unk>.
The delivery of 15 late breaking oral presentations at major clinical Congresses, and the initiation of three new phase III program for 2024 are targeted milestones laid out on slide 24 include an update on incentives three in first line PD lone negative metastatic triple negative breast cancer and update on tropics <unk>. We're assessing overall survival in second line metastatic or locally advanced bladder cancer and an update on our phase III purpose, one trial assessing lending cap of ear in HIV prevention. As previously highlighted we are also looking forward to the start of phase III trials for <unk> and endometrial cancer and the artistry trials. Evaluating lending cap of your <unk> Tegra of your oral combination for HIV treatment. Our commitment to develop innovative new therapeutic options is unchanged and we are confident that we will make progress on that commitment in 2024. And now I'll hand, the call over to Andy.
Speaker Change: In the fourth quarter of last year, we presented 26 abstracts at the American Society of Hematology meeting in December.
Speaker Change: <unk> has continued to generate some of the longest follow up and most robust datasets for cell therapies with the potential to transform patient lives also at ash, our partner arched Alex presented impressive updated data from the phase one trial evaluating <unk> in 38 patients with relapsed or refractory multiple myeloma.
We're assessing overall survival in second line metastatic or locally advanced bladder cancer and an update on our phase III purpose, one trial assessing lending cap of ear in HIV prevention. As previously highlighted we are also looking forward to the start of phase III trials for <unk> and endometrial cancer and the artistry trials. Evaluating lending cap of your <unk> Tegra of your oral combination for HIV treatment. Our commitment to develop innovative new therapeutic options is unchanged and we are confident that we will make progress on that commitment in 2024. And now I'll hand, the call over to Andy.
At a median follow up of $26 five months median progression free survival was not yet reached despite 70% of patients, having one or more high risk pregnancies factors.
Evaluating lending cap of your <unk> Tegra of your oral combination for HIV treatment. Our commitment to develop innovative new therapeutic options is unchanged and we are confident that we will make progress on that commitment in 2024. And now I'll hand, the call over to Andy.
Speaker Change: Given as potentially differentiated safety profile with notably no delayed neurotoxicity date, including Parkinsonism Nieto cell has the potential to become the best in class <unk> car T.
Our commitment to develop innovative new therapeutic options is unchanged and we are confident that we will make progress on that commitment in 2024. And now I'll hand, the call over to Andy.
And now I'll hand, the call over to Andy.
Speaker Change: We look forward to sharing an update from the pivotal phase III imagine one study and initiating an earlier line multiple myeloma trial later this year.
Andrew D. Dickinson: Thank you, Merdad, and good afternoon, everyone. Starting on slide 26, we closed the year with total product sales of $26.9 billion dollars, at the top end of our guidance range, due to a strong contribution from Veklury. For the full year, total product sales, excluding Veklury, grew 7%, driven by growth in both HIV and oncology. HIV increased 6% year over year, driven by Biktarvy, which grew 14% from 2022 to $11.8 billion dollars, and oncology grew to $2.9 billion dollars for the full year, an increase of $792 million dollars, or 37% from 2022. Altogether, total product sales, excluding Veklury, were $24.7 billion dollars, modestly below the lower end of our full year guidance range, largely due to quarterly pricing variability in HIV in the fourth quarter. Importantly, HIV volumes were in line with our expectations, and we are confident in our full year revenue growth expectations for HIV in 2024. Veklury revenue of $2.2 billion dollars exceeded our guidance of approximately $1.9 billion dollars and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022, full year Veklury revenue declined as expected and represented a headwind of more than $1.7 billion dollars to total product sales. This was largely offset by almost $1.7 billion dollars in growth from our base business, resulting in roughly flat total product sales year over year.
Starting on slide 26, we closed the year with total product sales of $26 9 billion. At the top end of our guidance range due to a strong contribution from Vivek Laurie. For the full year total product sales, excluding VAT glory grew 7% driven by growth in both HIV and oncology. HIV increased 6% year over year, driven by Victor <unk>, which grew 14% from 2022 to $11 $8 billion and oncology grew to $2 9 billion for the full year, an increase of $792 million or 37% from 2022. Altogether total product sales, excluding <unk> were $24 7 billion modestly below the lower end of our full year guidance range largely due to quarterly pricing variability in HIV in the fourth quarter. Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024. <unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: In terms of manufacturing, while Kate is already the clear leader.
At the top end of our guidance range due to a strong contribution from Vivek Laurie. For the full year total product sales, excluding VAT glory grew 7% driven by growth in both HIV and oncology. HIV increased 6% year over year, driven by Victor <unk>, which grew 14% from 2022 to $11 $8 billion and oncology grew to $2 9 billion for the full year, an increase of $792 million or 37% from 2022. Altogether total product sales, excluding <unk> were $24 7 billion modestly below the lower end of our full year guidance range largely due to quarterly pricing variability in HIV in the fourth quarter. Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024. <unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: Pleased to highlight that the FDA approved our updated process that reduces the turnaround time for Ya scarring in the U S from 16 days down to 14 days.
For the full year total product sales, excluding VAT glory grew 7% driven by growth in both HIV and oncology. HIV increased 6% year over year, driven by Victor <unk>, which grew 14% from 2022 to $11 $8 billion and oncology grew to $2 9 billion for the full year, an increase of $792 million or 37% from 2022. Altogether total product sales, excluding <unk> were $24 7 billion modestly below the lower end of our full year guidance range largely due to quarterly pricing variability in HIV in the fourth quarter. Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024. <unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: This further extends our leadership in cell therapy, and we continue to identify additional opportunities to reliably bring these much needed therapies to more patients as quickly as possible.
HIV increased 6% year over year, driven by Victor <unk>, which grew 14% from 2022 to $11 $8 billion and oncology grew to $2 9 billion for the full year, an increase of $792 million or 37% from 2022. Altogether total product sales, excluding <unk> were $24 7 billion modestly below the lower end of our full year guidance range largely due to quarterly pricing variability in HIV in the fourth quarter. Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024. <unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: Beyond manufacturing.
Speaker Change: Ongoing cell therapy trials of which four are evaluating new indications and four are exploring earlier lines of therapy.
Speaker Change: As we formally wrap up 2023 on slide 23, I would like to acknowledge the work of our clinical teams, who executed on our ambitious and broad portfolio that extends far beyond the lists shown including the advancement of eight new assets into the clinic the.
Altogether total product sales, excluding <unk> were $24 7 billion modestly below the lower end of our full year guidance range largely due to quarterly pricing variability in HIV in the fourth quarter. Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024. <unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: The delivery of 15 late breaking oral presentations at major clinical Congresses, and the initiation of three new phase III programs for 2024 are targeted milestones laid out on slide 24 include an update on incentives three in first line PD lone negative metastatic triple negative breast cancer and update on tropics <unk>.
Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024. <unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
<unk> revenue of $2 2 billion exceeded our guidance of approximately $1 9 million and reflected higher hospitalization rates in the latter part of 2023. Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: For assessing overall survival in second line metastatic or locally advanced bladder cancer and an update on our phase III purpose, one trial assessing lending <unk> in HIV prevention as previously highlighted we.
Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales. This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Speaker Change: We are also looking forward to the start of phase III trials for <unk> and endometrial cancer and the artistry trials evaluating lending cap of your <unk> of your oral combination for HIV treatment.
On slide 27, our non-GAAP results were largely as expected, including gross margin and operating expenses, notably R&D, which show disciplined moderation as we progress through 2023. Non-GAAP EPS was $6.72 and within our guidance range, despite the incremental ten cents of acquired IP R&D associated with the Arcellx and Compugen partnerships that we announced following our guidance revision in November of 2023. A quick note that our GAAP results were impacted by some restructuring expenses, primarily related to our manufacturing strategy and our activities at Kite. As we discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million dollars of associated expenses in 2023, or 40 cents per share, and contributed to GAAP EPS of $4.40 for the full year. Moving to our fourth quarter results, starting on slide 28 total product sales, excluding VAT glory were $6 three. $3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
On slide 27, our non-GAAP results were largely as expected, including gross margin and operating expenses, notably R&D, which show disciplined moderation as we progress through 2023. Non-GAAP EPS was $6.72 and within our guidance range, despite the incremental ten cents of acquired IP R&D associated with the Arcellx and Compugen partnerships that we announced following our guidance revision in November of 2023. A quick note that our GAAP results were impacted by some restructuring expenses, primarily related to our manufacturing strategy and our activities at Kite. As we discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million dollars of associated expenses in 2023, or 40 cents per share, and contributed to GAAP EPS of $4.40 for the full year.
Speaker Change: Our commitment to develop innovative new therapeutic options is unchanged and we are confident that we will make progress on that commitment in 2024, and now I hand, the call over to Andy.
non-GAAP EPS was $6 72. And within our guidance range. Despite the incremental tons of acquired IP R&D associated with the <unk> and <unk> partnerships that we announced following our guidance revision in November of 2023, a quick note that our GAAP results were impacted by some restructuring expenses, primarily related to our manufacturing strategy and our activities. Right. We discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or <unk> 40 per share and contributed to GAAP EPS of $4 40 for the full year moving to our fourth quarter results starting on slide 28 total product sales, excluding VAT glory were $6 three. $3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Andy: Thank you Mehrdad and good afternoon, everyone.
And within our guidance range. Despite the incremental tons of acquired IP R&D associated with the <unk> and <unk> partnerships that we announced following our guidance revision in November of 2023, a quick note that our GAAP results were impacted by some restructuring expenses, primarily related to our manufacturing strategy and our activities. Right. We discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or <unk> 40 per share and contributed to GAAP EPS of $4 40 for the full year moving to our fourth quarter results starting on slide 28 total product sales, excluding VAT glory were $6 three. $3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Andy: Starting on slide 26, we closed the year with total product sales of $26 $9 billion at the top end of our guidance range due to a strong contribution from Vivek Laurie.
Andy: For the full year total product sales, excluding <unk> grew 7% driven by growth in both HIV and oncology.
Right. We discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or <unk> 40 per share and contributed to GAAP EPS of $4 40 for the full year moving to our fourth quarter results starting on slide 28 total product sales, excluding VAT glory were $6 three. $3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
We discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024. As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or <unk> 40 per share and contributed to GAAP EPS of $4 40 for the full year moving to our fourth quarter results starting on slide 28 total product sales, excluding VAT glory were $6 three. $3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
HIV increased 6% year over year, driven by <unk>, which grew 14% from 2022 to $11 $8 billion and oncology grew to $2 9 billion for the full year, an increase of $792 million or 37% from 2022.
As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or <unk> 40 per share and contributed to GAAP EPS of $4 40 for the full year moving to our fourth quarter results starting on slide 28 total product sales, excluding VAT glory were $6 three. $3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Andy: Altogether total product sales, excluding <unk> were $24 7 billion.
Moving to our fourth quarter results, starting on slide 28, total product sales, excluding Veklury, were $6.3 billion dollars. Including Veklury, total product sales of $7.1 billion dollars were down 4% from the same quarter in 2022. As expected Veklury sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Andy: Modestly below the lower end of our full year guidance range, largely due to quarterly pricing variability in HIV in the fourth quarter.
$3 billion. Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022. As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Andy: Importantly, HIV volumes were in line with our expectations and we are confident in our full year revenue growth expectations for HIV in 2024.
As expected like lottery sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
Andy: Regulatory revenue of $2 $2 billion exceeded our guidance of approximately $1 9 billion.
On slide 29, you can see that on a non-GAAP basis, product gross margin was 86%, down 66 basis points from the prior year. R&D expenses were $1.5 billion dollars, down 6% year over year. Acquired IP R&D was $347 million, reflecting payments related to our collaborations with Arcellx, Assembly Biosciences, and Compugen, and our Xinthera acquisition. SG&A was $1.6 billion dollars, down 21% year over year, primarily related to the 2022 charge for the termination of the Everest collaboration that did not repeat in 2023. Excluding this 2022 charge, non-GAAP SG&A was down 1%. Operating margin was 39%, up from 37% in the fourth quarter of 2022, and effective tax rate in the fourth quarter was 17%, flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter, compared to $1.67 in the fourth quarter of 2022.
Andy: And reflected higher hospitalization rates in the latter part of 2023.
Andy: Compared to 2022 full year veterinary revenue declined as expected and represented a headwind of more than $1 $7 billion to total product sales.
R&D expenses were $1 $5 billion down 6% year over year acquired IP R&D was $347 million, reflecting payments related to our collaborations with our <unk> Assembly biosciences, and competent and ours in Thera acquisition SG&A was $1 $6 billion down 21. <unk> year over year, primarily related to the 2022 charge for the termination of the <unk> collaboration that did not repeat in 2023. Excluding this 2022 charge. non-GAAP SG&A was down 1%. Operating margin was 39% up from 37% in the fourth quarter of 2022 and effective tax rate in the fourth quarter was 17% flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Andy: This was largely offset by almost $1 7 billion and growth from our base business, resulting in roughly flat total product sales year over year.
Andy: On slide 27, our non-GAAP results were largely as expected, including gross margin and operating expenses, notably R&D, which showed disciplined moderation as we progress through 2023.
<unk> year over year, primarily related to the 2022 charge for the termination of the <unk> collaboration that did not repeat in 2023. Excluding this 2022 charge. non-GAAP SG&A was down 1%. Operating margin was 39% up from 37% in the fourth quarter of 2022 and effective tax rate in the fourth quarter was 17% flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Excluding this 2022 charge. non-GAAP SG&A was down 1%. Operating margin was 39% up from 37% in the fourth quarter of 2022 and effective tax rate in the fourth quarter was 17% flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Andy: non-GAAP EPS was $6 72.
non-GAAP SG&A was down 1%. Operating margin was 39% up from 37% in the fourth quarter of 2022 and effective tax rate in the fourth quarter was 17% flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Andy: And within our guidance range. Despite the incremental 10 cents of acquired IP R&D associated with the <unk> and <unk> partnerships that we announced following our guidance revision in November of 2023, a quick note that our GAAP results were impacted by some restructuring expenses, primarily related to our manufacturing strategy and our activities at <unk>.
Operating margin was 39% up from 37% in the fourth quarter of 2022 and effective tax rate in the fourth quarter was 17% flat compared to the prior year. Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Overall, our non-GAAP diluted earnings per share was $1.72 in the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Andy: As we discussed in the later part of 2023, we have been taking steps to evolve our business model and expense structure to set us up for a strong 2024.
I'll move now to slide 30 and our guidance, which assumes a generally stable macro environment, including FX at current rates. For the full year 2024, we expect total product sales in the range of $27.1 to $27.5 billion dollars. We expect total product sales, excluding Veklury, in the range of $25.8 to $26.2 billion dollars, representing growth of 4% to 6% for our base business year over year. Within total product sales, and as Johanna discussed, we expect HIV revenue to grow approximately 4%. And we expect Veklury sales of approximately $1.3 billion, although as always we caution you that Veklury sales remain highly variable depending on hospitalization rates. We do not expect to update our Veklury guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L, and on a non-GAAP basis, we expect product gross margin to range between 85% to 86%, modestly lower than the 86.1% reported in 2023, due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active Phase III programs. We expect acquired IP R&D to be approximately $350 million dollars. Consistent with our approach in 2023, we will highlight incremental acquired IP R&D expenses as we announce new transactions and update our guidance each quarter. And we expect SG&A to decline by a mid single digit percentage compared to 2023. Excluding the $525 million legal settlement in 2023, we expect SG&A to grow in the low to mid single digit percentage range compared to SG&A of $5 $5 billion in 2023, excluding this settlement as a result, we expect our operating income for 2024 to be between 11 two. And $11 7 billion. We expect our effective tax rate to be approximately 19%. And finally, we expect our non-GAAP non diluted EPS to be between $6 85 and. $7 25 per share for the full year and GAAP diluted EPS to be between $5.15 and $5 55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
I'll move now to slide 30 and our guidance, which assumes a generally stable macro environment, including FX at current rates. For the full year 2024, we expect total product sales in the range of $27.1 to $27.5 billion dollars. We expect total product sales, excluding Veklury, in the range of $25.8 to $26.2 billion dollars, representing growth of 4% to 6% for our base business year over year. Within total product sales, and as Johanna discussed, we expect HIV revenue to grow approximately 4%. And we expect Veklury sales of approximately $1.3 billion, although as always we caution you that Veklury sales remain highly variable depending on hospitalization rates. We do not expect to update our Veklury guidance until our third quarter earnings call, absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L, and on a non-GAAP basis, we expect product gross margin to range between 85% to 86%, modestly lower than the 86.1% reported in 2023, due to the growing contribution from our oncology portfolio.
Andy: As a result, our GAAP results reflect approximately $500 million of associated expenses in 2023, or <unk> 40 per share and contributed to GAAP EPS of $4 40 for the full year moving to our fourth quarter results starting on slide 28 total product sales, excluding <unk> were $6 three.
For the full year 2024. We expect total product sales in the range of 27, one to $27 5 billion. We expect total product sales, excluding VAT glory in the range of $25 eight to $26 2 billion representing growth of 46% for our base business year over year. Within total product sales and as Joanna discussed, we expect HIV revenue to grow approximately 4%. And we expect <unk> sales of approximately $1 $3 billion, although as always we caution you that veterinary sales remained highly variable depending on hospitalization rates, we do not expect to update our veterinary guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L and on a non-GAAP basis. We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
We expect total product sales in the range of 27, one to $27 5 billion. We expect total product sales, excluding VAT glory in the range of $25 eight to $26 2 billion representing growth of 46% for our base business year over year. Within total product sales and as Joanna discussed, we expect HIV revenue to grow approximately 4%. And we expect <unk> sales of approximately $1 $3 billion, although as always we caution you that veterinary sales remained highly variable depending on hospitalization rates, we do not expect to update our veterinary guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L and on a non-GAAP basis. We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
We expect total product sales, excluding VAT glory in the range of $25 eight to $26 2 billion representing growth of 46% for our base business year over year. Within total product sales and as Joanna discussed, we expect HIV revenue to grow approximately 4%. And we expect <unk> sales of approximately $1 $3 billion, although as always we caution you that veterinary sales remained highly variable depending on hospitalization rates, we do not expect to update our veterinary guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L and on a non-GAAP basis. We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
Andy: $3 billion.
Andy: Including <unk> total product sales of $7 $1 billion were down 4% from the same quarter in 2022.
Within total product sales and as Joanna discussed, we expect HIV revenue to grow approximately 4%. And we expect <unk> sales of approximately $1 $3 billion, although as always we caution you that veterinary sales remained highly variable depending on hospitalization rates, we do not expect to update our veterinary guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L and on a non-GAAP basis. We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
Andy: As expected like Lori sales decreased year over year due to lower rates of COVID-19 related hospitalizations.
And we expect <unk> sales of approximately $1 $3 billion, although as always we caution you that veterinary sales remained highly variable depending on hospitalization rates, we do not expect to update our veterinary guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections. Moving to the rest of the P&L and on a non-GAAP basis. We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
Andy: On slide 29, you can see that on a non-GAAP basis product gross margin was 86% down 66 basis points from the prior year.
Andy: R&D expenses were $1 $5 billion down 6% year over year acquired IP R&D was $347 million, reflecting payments related to our collaborations with our <unk> Assembly biosciences and competition and ours in Thera acquisition, SG&A was $1 $6 billion down 21%.
Moving to the rest of the P&L and on a non-GAAP basis. We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
We expect product gross margin to range between $85 to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio. We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active Phase III programs. We expect acquired IP R&D to be approximately $350 million dollars. Consistent with our approach in 2023, we will highlight incremental acquired IP R&D expenses as we announce new transactions and update our guidance each quarter. And we expect SG&A to decline by a mid single digit percentage compared to 2023. Excluding the $525 million dollar legal settlement in 2023, we expect SG&A to grow in the low to mid single digit percentage range, compared to SG&A of $5.5 billion dollars in 2023, excluding this settlement. As a result, we expect our operating income for 2024 to be between $11.2 and $11.7 billion dollars. We expect our effective tax rate to be approximately 19%. And finally, we expect our non-GAAP, non-diluted EPS to be between $6.85 and $7.25 per share for the full year, and GAAP-diluted EPS to be between $5.15 and $5.55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023, similar to what we saw in the first quarter of 2023. And cell therapy to be flat to slightly up from Q4 of 2023.
Andy: Year over year, primarily related to the 2022 charge for the termination of the Everest collaboration that did not repeat in 2023 excluding.
We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
Andy: Excluding this 2022 charge non-GAAP SG&A was down 1%.
Andy: Operating margin was 39% up from 37% in the fourth quarter of 2022 and effective tax rate in the fourth quarter was 17% flat compared to the prior year.
Consistent with our approach in 2023, we will highlight incremental acquired IP R&D expenses as we announce new transactions and update our guidance each quarter.
And we expect SG&A to decline by a mid single digit percentage compared to 2023.
Andy: Overall, our non-GAAP diluted earnings per share was $1 72 for the fourth quarter compared to $1 67 in the fourth quarter of 2022.
Excluding the $525 million legal settlement in 2023, we expect SG&A to grow in the low to mid single digit percentage range compared to SG&A of $5 $5 billion in 2023, excluding this settlement as a result, we expect our operating income for 2024 to be between 11 two. And $11 7 billion. We expect our effective tax rate to be approximately 19%. And finally, we expect our non-GAAP non diluted EPS to be between $6 85 and. $7 25 per share for the full year and GAAP diluted EPS to be between $5.15 and $5 55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
Andy: I'll move now to slide 30, and our guidance, which assumes a generally stable macro environment, including FX at current rates.
Andy: For the full year 2024.
We expect total product sales in the range of $27, one to $27 5 billion.
And $11 7 billion. We expect our effective tax rate to be approximately 19%. And finally, we expect our non-GAAP non diluted EPS to be between $6 85 and. $7 25 per share for the full year and GAAP diluted EPS to be between $5.15 and $5 55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
We expect total product sales, excluding VAT glory in the range of 25, eight to $26 $2 billion, representing growth of 4% to 6% for our base business year over year.
We expect our effective tax rate to be approximately 19%. And finally, we expect our non-GAAP non diluted EPS to be between $6 85 and. $7 25 per share for the full year and GAAP diluted EPS to be between $5.15 and $5 55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
And finally, we expect our non-GAAP non diluted EPS to be between $6 85 and. $7 25 per share for the full year and GAAP diluted EPS to be between $5.15 and $5 55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
$7 25 per share for the full year and GAAP diluted EPS to be between $5.15 and $5 55. As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
Andy: Within total product sales and as Joanna discussed, we expect HIV revenue to grow approximately 4%.
Andy: And we expect <unk> sales of approximately $1 $3 billion, although as always we caution you that veterinary sales remained highly variable depending on hospitalization rates, we do not expect to update our vexillary guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections.
As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
Andy: Moving to the rest of the P&L and on a non-GAAP basis.
Moving to capital allocation on slide 31. Our priorities have not changed. In 2023, we returned $4.8 billion dollars to our shareholders. This included $3.8 billion dollars in dividend payments, and $1 billion dollars in share repurchases. Fourth quarter share repurchases were $150 million dollars. For 2024, we announced today a 2.7% increase in our quarterly cash dividend to $.77 per share, and we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally, through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution, as well as additional repurchases on an opportunistic basis. With that, I'll invite the operator to begin the Q&A.
Andy: We expect product gross margin to range between 85% to 86% modestly lower than the 86, 1% reported in 2023 due to the growing contribution from our oncology portfolio.
Our priorities have not changed. In 2023, we returned $4 $8 billion to our shareholders. This. This included $3 $8 billion in dividend payments and $1 billion in share repurchases. Fourth quarter share repurchases were $150 million. For 2024, we announced today, a two 7% increase in our quarterly cash dividend to <unk> 77 per share. And we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
In 2023, we returned $4 $8 billion to our shareholders. This. This included $3 $8 billion in dividend payments and $1 billion in share repurchases. Fourth quarter share repurchases were $150 million. For 2024, we announced today, a two 7% increase in our quarterly cash dividend to <unk> 77 per share. And we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
This included $3 $8 billion in dividend payments and $1 billion in share repurchases. Fourth quarter share repurchases were $150 million. For 2024, we announced today, a two 7% increase in our quarterly cash dividend to <unk> 77 per share. And we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
Andy: We expect R&D to grow by a low to mid single digit percentage compared to 2023, highlighting the substantial moderation in expense growth as we approach a steadier state of active phase III programs, we expect acquired IP R&D to be approximately $350 million.
Fourth quarter share repurchases were $150 million. For 2024, we announced today, a two 7% increase in our quarterly cash dividend to <unk> 77 per share. And we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
For 2024, we announced today, a two 7% increase in our quarterly cash dividend to <unk> 77 per share. And we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
And we remain committed to growing our dividend over time in line with our earnings growth. You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
Andy: Consistent with our approach in 2023, we will highlight incremental acquired IP R&D expenses, as we announce new transactions and update our guidance each quarter.
You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
Andy: And we expect SG&A to decline by a mid single digit percentage compared to 2023.
Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis. With that I'll invite the operator to begin the Q&A.
Andy: Excluding the $525 million legal settlement in 2023, we expect SG&A to grow in the low to mid single digit percentage range compared to SG&A of $5 5 billion in 2023, excluding the settlement as a result, we expect our operating income for 2024 to be between 11 two.
With that I'll invite the operator to begin the Q&A.
Operator: Of course, Andrew. We will now begin the question and answer session. In the interest of time, we ask that everyone limit one question.
We will now begin the question and answer session. In the interest of time, we ask that everyone limit one question.
In the interest of time, we ask that everyone limit one question.
[inaudible] As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
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Operator: As a reminder, if you are using a speaker phone, please remember to pick up your handset before asking a question. We will pause here briefly as questions are registered. Our first question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.
Operator: As a reminder, if you are using a speaker phone, please remember to pick up your handset before asking a question. We will pause here briefly as questions are registered.
You asked the question. But I want. You bet. Great. Thanks for that question. I would like to get the <unk>. Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Andy: And $11 7 billion.
But I want. You bet. Great. Thanks for that question. I would like to get the <unk>. Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Andy: We expect our effective tax rate to be approximately 19%.
You bet. Great. Thanks for that question. I would like to get the <unk>. Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Great. Thanks for that question. I would like to get the <unk>. Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Thanks for that question. I would like to get the <unk>. Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Andy: And finally, we expect our non-GAAP non diluted EPS to be between $6 85 and.
I would like to get the <unk>. Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Mr. Wang. If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
$7 25 per share for the full year and GAAP diluted EPS to be between $5 15, and $5 55.
If you are using speaker phone. Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Okay. As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Andy: As a reminder, for the first quarter of 2024, we expect HIV to decline sequentially in the 10% to 12% range from Q4 2023 similar to what we saw in the first quarter of 2023 and cell therapy to be flat to slightly up from Q4 of 2023.
As a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question.
Operator: Our first question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.
Please remember to pick up your handset before asking a question.
We will pause here briefly ask questions are registered.
Our first question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.
Andy: Moving to capital allocation on slide 31.
Your line is now open.
Andy: Our priorities have not changed.
Tyler Van Buren: Hey, guys, good afternoon. Regarding the 2024 product sales guidance, I understand you guys are guiding to a near $900 million sales drop off year over year for Veklury, but the guidance ex-Veklury looks to be a 5% year over year growth at the midpoint versus 7% for this year. So what do you view as some of the levers to ex-Veklury product sales guidance in 2024 where we could see upside?
Andy: In 2023, we returned $4 $8 billion to our shareholders. This.
Andy: This included $3 $8 billion in dividend payments and $1 billion in share repurchases.
900 million sales drop off year over year for victory, but the guidance ex February looks to be a 5% year over year growth at the midpoint versus 7% for this year. So what do you view as some of the levers to expect worthy product sales guidance and 24, where we could see upside.
Andy: Fourth quarter share repurchases were $150 million.
Andy: For 2024, we announced today, a two 7% increase in our quarterly cash dividend to <unk> 77 per share.
Andy: And we remain committed to growing our dividend over time in line with our earnings growth.
Daniel O'Day: Thanks, Tyler, welcome. Let's have Andy start.
Andy starts.
Andy: You can also expect to see continued investments in our business, both internally and externally through select partnerships and business development transactions.
Hey, Tyler, it's Andy, thanks for the question. You're absolutely right, our product sales guidance for products excluding Veklury implies 4% to 6% growth year over year, again continuing the trend of strong growth that you've seen over the last two years. I'd also highlight that it implies a substantial moderation of our operating expense growth, which is an important piece of the puzzle that we spent a lot of time talking about. To your question specifically on product growth, the growth drivers for 2024 are the same as the growth drivers last year, you continue to see strong growth in our HIV business. As you see in the quarter, you really need to focus on the full year for HIV to see the growth trends that we saw another year of very strong growth across our HIV business for the full year in '23 and we expect the same thing in '24, and you heard on the call that we're expecting at least 4% growth for the HIV business next year. And then of course the cell therapy business and Trodelvy are expected to continue to grow as well. So those are the key growth drivers. We look forward to updating you throughout the year, but we're excited about the setup as we move into 2024.
Andy: Finally, we will continue to utilize share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis.
I would also highlight. But it implies a substantial moderation of our of our operating expense growth, which is an important piece of the puzzle that we spent a lot of time talking about. Your question, specifically on product growth, but the growth drivers for 2024, the same as the growth drivers last year, you continue to see strong growth in our HIV business as you see in the quarter.
But it implies a substantial moderation of our of our operating expense growth, which is an important piece of the puzzle that we spent a lot of time talking about. Your question, specifically on product growth, but the growth drivers for 2024, the same as the growth drivers last year, you continue to see strong growth in our HIV business as you see in the quarter.
Andy: With that I'll invite the operator to begin the Q&A.
Operator: Of course, Andrew.
Operator: We will now begin the question and answer session.
Your question, specifically on product growth, but the growth drivers for 2024, the same as the growth drivers last year, you continue to see strong growth in our HIV business as you see in the quarter.
Speaker Change: In the interest of time, we ask that everyone limit one question.
Speaker Change: Yep.
Operator: You ask a question please.
Really need to focus on the full year for <unk>.
Operator: Taiwan.
To see the growth trends that we saw another year of very strong growth across our HIV business for the full year in 'twenty. Three we expect the same thing in 'twenty four and you heard on the call that we were expecting at least 4% growth for the HIV business next year, and then of course, the cell therapy business and.
Operator: That's right.
Operator: Quick question.
Speaker Change: Alright, thank you.
Speaker Change: Good question.
Speaker Change: Yes.
Speaker Change: Thank you are using speaker phone.
<unk> are expected to continue to grow as well. So those are the key growth drivers. We look forward to updating you throughout the year, but we're excited about about the setup as we move into 2024.
Speaker Change: Sorry about that.
Speaker Change: Reminder, if you are using a speaker phone.
Speaker Change: Please remember to pick up your handset before asking a question.
Operator: Thank you so much. Of course, thank you so much for your question. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.
Speaker Change: We will pause here briefly ask questions registered.
Thank you so much.
Speaker Change: Our first question comes from the line of Tyler Van Buren with TD Cowen.
Of course, thank you so much for your question. Our next question comes from the line of <unk> Richter with. Goldman Sachs. Your line is now open.
Speaker Change: Your line is now open.
Goldman Sachs. Your line is now open.
Speaker Change: Hey, guys. Good afternoon regarding the 'twenty 'twenty four product sales guidance I understand you guys are guiding to a near 900 million sales drop off year over year for victory, but the guidance ex regulatory looks to be a 5% year over year growth at the midpoint versus 7% for this year. So what do you view.
Salveen Jaswal Richter: Good afternoon, thanks for taking my question. On business development, you have noted the potential for a $5 to $6 billion dollar deal in oncology or INI. Where are you seeing the greatest opportunity to leverage your current clinical and commercial infrastructure? Thank you.
Are you seeing the greatest opportunity to leverage your current clinical and commercial infrastructure. Thank you.
Great. Thanks, Salveen. This is Dan, maybe I'll start and then ask others to add, but appreciate the question. I think just to reinforce our M&A strategy, I mean nothing has changed from a business development perspective, and particularly that's against the context of the background of nearly doubling our clinical trials underway over the past four years. Multiple late stage results, as you know we're expecting more than 20 results still this year. And against the backdrop of no significant patent expirations in our business until early parts of the next decade. So I think we'll continue to be opportunistic about pursuing business development in the three areas that we are focused on, which is obviously virology, oncology, and inflammation. We'll be driven by the science, and we continue to articulate that building our late research early development pipeline is probably one of our biggest focuses, and we'll continue to look at later-stage deals as they fit into our portfolio or our range. It might also be important to note that we are back to pre-Immunomedics levels now relative to our leverage ratios and so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within Gilead right now to achieve our ambitions over the second half of this decade.
Speaker Change: Some of the levers to expect worthy product sales guidance, and 24, where we could see upside.
The question I think just to reinforce our M&A strategy I mean, nothing has changed from a business development perspective, and particularly that's against the context of.
Speaker Change: Thanks, Tyler welcome.
Andy: Andy starts.
Andy: Hey, Tyler Thanks for the question, you're absolutely right our product sales guidance for products, excluding back Larry implies 4% to 6% growth year over year again, continuing the trend of strong growth that you've seen over the last two year.
The background of nearly doubling our clinical trials underway over the past four years multiple late stage results as you know we're expecting more than 20, our results still this year.
Andy: I'd also highlight.
And against the backdrop of no significant patent expirations.
Andy: Let it implies a substantial moderation of our of our operating expense growth, which is an important piece of the puzzle that we spent a lot of time talking about.
And our business until early parts of the next decade. So I think we'll continue to. Be opportunistic about pursuing business development. And the three areas that we are focused on which is obviously virology oncology and inflammation will be driven by the science and we continue to articulate that. Building, our late research and early development pipeline is probably one of our biggest focus is and will continue to look at later stage deals as they fit into our portfolio or a range that might also be. Important to note. We are back to pre immunomedics levels now relative to. Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
Andy: To your question, specifically on product growth, but the growth drivers for 2024, the same as the growth drivers last year, you continue to see strong growth in our HIV business as you see in the quarter, you really need to focus on the full year for HIV to see the growth trends that we saw another year of very strong growth across our HIV business for the full year in 'twenty three.
Be opportunistic about pursuing business development. And the three areas that we are focused on which is obviously virology oncology and inflammation will be driven by the science and we continue to articulate that. Building, our late research and early development pipeline is probably one of our biggest focus is and will continue to look at later stage deals as they fit into our portfolio or a range that might also be. Important to note. We are back to pre immunomedics levels now relative to. Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
And the three areas that we are focused on which is obviously virology oncology and inflammation will be driven by the science and we continue to articulate that. Building, our late research and early development pipeline is probably one of our biggest focus is and will continue to look at later stage deals as they fit into our portfolio or a range that might also be. Important to note. We are back to pre immunomedics levels now relative to. Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
Building, our late research and early development pipeline is probably one of our biggest focus is and will continue to look at later stage deals as they fit into our portfolio or a range that might also be. Important to note. We are back to pre immunomedics levels now relative to. Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
Andy: We expect the same thing in 'twenty four and you heard on the call that we were expecting at least 4% growth for the HIV business next year, and then of course the cell therapy business.
Andy: <unk> are expected to continue to grow as well. So those are the key growth drivers. We look forward to updating you throughout the year, but we're excited about about the setup as we move into 2024.
Important to note. We are back to pre immunomedics levels now relative to. Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
We are back to pre immunomedics levels now relative to. Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
Our leverage ratios. <unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
Andy: Yes.
<unk>. And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
And so we're comfortable with our ability to put capital to work, but nothing has changed and we feel we have everything within. Gilead right now to achieve our ambitions over the second half of this decade.
Speaker Change: Thank you so much.
Speaker Change: Of course, thank you so much for your question. Our next question comes from the line of <unk> Richter with.
Gilead right now to achieve our ambitions over the second half of this decade.
Richter: With Goldman Sachs. Your line is now open.
Richter: Good afternoon. Thanks for taking my question on business development, you have noted the potential for a 5% to $6 billion deal in oncology are ini.
Jackie Ross: Victoria, may we have our next question, please.
Operator: Of course. The next question comes from the line of Carter Gould with Barclays. Your line is now open hi, this is Leon.
Operator: Of course. The next question comes from the line of Carter Gould with Barclays. Your line is now open
The next question comes from the line of Carter Gould with Barclays. Your line is now open hi, this is Leon.
The next question comes from the line of Carter Gould with Barclays. Your line is now open hi, this is Leon.
Richter: Or are you seeing the greatest opportunity to leverage your current clinical and commercial infrastructure. Thank you.
Your line is now open hi, this is Leon.
Leon Wang: Hi, this is Leon. Hi, this is Leon Wang, on for Carter. Thanks for taking my question. So at this point, what conviction do you have anito-cel will differentiate on neurotox or Parkinsonism versus your competitors, and if the lack of neuro Tox data recapitulate later this year, would that be derisking in your view, and how important would that be in the market. Thank you.
hi, this is Leon.
Hi, This is al Wang on for Carter. Thanks for taking my question. So at this point what conviction do you have an ear. So will differentiate on neuro tox or parkinsonian is cause them versus your competitors and. The lack of neuro Tox data recapitulate later this year would that be a derisking in your view and how important would that be in the market. Thank you.
Richter: Great. Thanks, Alvin This is Dan maybe I'll start and then ask others to add but.
Richter: Sure.
Dan: Question, I think just to reinforce our M&A strategy I mean, nothing has changed from a business development perspective.
The lack of neuro Tox data recapitulate later this year would that be a derisking in your view and how important would that be in the market. Thank you.
Dan: And particularly that's against the context of the <unk>.
Dan: Background of nearly doubling our clinical trials underway over the past four years multiple late stage results as you know we're expecting more than 20 results still this year.
Daniel O'Day: Thank you, so we've got Cindy Perettie here to handle that, thanks.
Dan: And against the backdrop of no significant patent expirations.
Cindy Perettie: Thank you for the question. I think with the Anito-cel data, we expect to complete the enrollment of our iMMagine-1 study this year, where we would have then one hundred patients' worth of data. And obviously, we're going to continue to look for safety signals, neurotox as you suggested, but to date we have not observed any. Your second part of that question was, do we see that as a differentiator, and I would definitely see that as a differentiator in the marketplace if we were to come forward with a differentiated safety profile. I think the other component to remind you of is we also believe it's possible to have a differentiated efficacy profile. And today, based on the D domain and our transduction efficiency, we're able to use half the dose that we're seeing with our competitors, and that could play both safety and efficacy. Thank you.
Dan: And our business until early parts of the next decade. So I think we'll continue to.
And obviously, we're going to continue to look for safety. Safety signal with neurotoxicity suggested but to date we. We have not observed. And your second part of that question was do we see that as a differentiator and I would definitely see that as a differentiator in the marketplace. If we were to come forward. Forward with a differentiated safety profile like what was the other component to it. It reminds me of it we also believe it's possible to have a differentiated efficacy profile. Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Dan: Be opportunistic about pursuing business development.
Safety signal with neurotoxicity suggested but to date we. We have not observed. And your second part of that question was do we see that as a differentiator and I would definitely see that as a differentiator in the marketplace. If we were to come forward. Forward with a differentiated safety profile like what was the other component to it. It reminds me of it we also believe it's possible to have a differentiated efficacy profile. Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Dan: The three areas that we are focused on which is obviously virology oncology and inflammation will be driven by the science and we continue to articulate that building are late research early development pipeline is probably one of our biggest focus is and will continue to look at later stage deals.
We have not observed. And your second part of that question was do we see that as a differentiator and I would definitely see that as a differentiator in the marketplace. If we were to come forward. Forward with a differentiated safety profile like what was the other component to it. It reminds me of it we also believe it's possible to have a differentiated efficacy profile. Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
And your second part of that question was do we see that as a differentiator and I would definitely see that as a differentiator in the marketplace. If we were to come forward. Forward with a differentiated safety profile like what was the other component to it. It reminds me of it we also believe it's possible to have a differentiated efficacy profile. Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Forward with a differentiated safety profile like what was the other component to it. It reminds me of it we also believe it's possible to have a differentiated efficacy profile. Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
It reminds me of it we also believe it's possible to have a differentiated efficacy profile. Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Dan: As they fit into our portfolio on a range.
Based on the deep domain. Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Dan: And by also the.
Vascular facility or able to use half the dose. What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Dan: Important to note that.
Dan: We are back to pre immunomedics levels now.
What we're seeing with our competitors and that could play both safety and efficacy. Thank you.
Dan: Relative to.
Dan: Our leverage ratios.
Jackie Ross: Great. Victoria, ready for our next question, please.
Dan: And.
Dan: And so we're comfortable with our ability to put capital to work.
Operator: Of course. Our next question comes from the line of Terence Flynn with Morgan Stanley. Your line is now open.
Dan: But nothing has changed and we feel we have everything within.
Your line is now open.
Dan: Gilead right now to achieve our ambitions over the second half of this decade.
Terence Flynn: Thanks for taking the question. We're just wondering if you could speak to your confidence level in Trodelvy in the frontline non small cell lung trial setting here, given the EVOKE-01 data, and if you're considering any potential changes to that frontline trial as a result, thank you.
Speaker Change: Our next question please.
Speaker Change: Of course.
Speaker Change: The next question comes from the line of Carter Gould with Barclays.
Carter Gould: Your line is now open hi, this is Leon.
Merdad V. Parsey: Hi Terence, this is Merdad. You know, I think when we have looked at the data so far, and we're looking forward to sharing it with everyone as quickly as we can, probably one of the most important things in that dataset that confirm where we were before is that we have not seen a difference in response rates between squamous cell carcinoma and non squamous cell carcinoma. I think that was a bit of an overhang in the fall, and as we had mentioned earlier, we have not seen that to date and that has been bolstered by the result of EVOKE-01. So we do think that that increases our confidence that we don't need to think about, look at that. Now there are other analyses we need to do to make sure that there are other predictors of response or not, and we'll be doing that and we'll be sharing that over time, but right now our overall confidence in Trodelvy broadly speaking remains very high. We have three approvals, and we have a broad development program against which we are executing really well. We continue to have additional trials that we'll read out this year in Phase III, specifically the TROPiCS-04 that will be looking at the bladder cancer confirmation study, with hopefully an OS signal. That study could actually give us, beyond confirmatory trial in the US, it allows us to open conversations with regulators outside the US. And then we have promised an update on ASCENT-03 in breast cancer, which we also think will broaden that, and then we now have a number of trials going on in a variety of indications, including ones we've mentioned in for example endometrial cancer. Overall, what we've seen in EVOKE-01 and we're looking forward to sharing with you really maintains our level of enthusiasm about Trodelvy's long term potential from an efficacy and safety standpoint across the board, and we have no plans to change EVOKE-03 at this time.
Carter Gould: Hi, This is Leon Wang on for Carter. Thanks for taking my question. So at this point what conviction do you have and you yourself will differentiate on neuro tox or parkinsonian cause them versus your competitors and it's.
Uh huh.
I think when we have looked at the data so far and we're looking forward to sharing it with everyone quick.
Quickly as we can.
I really wanted most important things in that dataset that confirm where we were before is that we have not seen a difference in response rates between squame squamous cell carcinoma, and non squamous cell carcinoma, I think that was a bit of an overhang in the fall and as we had mentioned earlier, we have not seen that to date in that.
Leon Wang: It's the lack of neuro Tox data recapitulate later this year would that be a derisking in your view and how important.
Leon Wang: Would that be in the market. Thank you.
Speaker Change: So we've got Cindy predator pedal there thanks.
Speaker Change: Thank you for the question I'm going to be a liter cell data, we expect to complete the enrollment of I imagine one study this year, where we would have been 100 patients worth of data.
It has been. Bolstered by the result of the Volcker, one so we do think that that. Increases our confidence that we don't need to think about. Oh look at that now there are other analysis, we need to do to make sure that there are other there are other predictors of response or not and we'll be doing that and we'll be sharing that over time, but right now our overall confidence in turd Lv broadly speaking remains very high we have. Three approval. And we have a broad development program. Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Bolstered by the result of the Volcker, one so we do think that that. Increases our confidence that we don't need to think about. Oh look at that now there are other analysis, we need to do to make sure that there are other there are other predictors of response or not and we'll be doing that and we'll be sharing that over time, but right now our overall confidence in turd Lv broadly speaking remains very high we have. Three approval. And we have a broad development program. Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Increases our confidence that we don't need to think about. Oh look at that now there are other analysis, we need to do to make sure that there are other there are other predictors of response or not and we'll be doing that and we'll be sharing that over time, but right now our overall confidence in turd Lv broadly speaking remains very high we have. Three approval. And we have a broad development program. Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Speaker Change: Obviously, we're going to continue to look for.
Oh look at that now there are other analysis, we need to do to make sure that there are other there are other predictors of response or not and we'll be doing that and we'll be sharing that over time, but right now our overall confidence in turd Lv broadly speaking remains very high we have. Three approval. And we have a broad development program. Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Speaker Change: Safety signal with neurotoxicity suggested but to date, we have not observed.
Speaker Change: Your second part of that question was do we see that as a differentiator and I would definitely see that as a differentiator in the marketplace. If we were to come.
Speaker Change: Forward with a differentiated safety profile I think the other component sort of reminds me a lot of it. We also believe it's possible to have a differentiated efficacy profile.
Three approval. And we have a broad development program. Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
And we have a broad development program. Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Against which we are executing really well. We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Based on the detail.
We continue to have additional trials that will read out this year and in phase three. Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Speaker Change: Thanks for that facility or are able to use half the dose.
Speaker Change: We are seeing with our competitors and that could play both safety and efficacy. Thank you.
Specifically the trophy of Trophy <unk> study that we'll be looking at the. Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Bladder cancer conformation study with hopefully an OS signal that study could. Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Speaker Change: Great.
Speaker Change: Our next question please.
Speaker Change: Of course, our next question comes from the line of Terence Flynn with Morgan Stanley.
Actually give us beyond. Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Confirmatory trial in the U S. It allows us to open. Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Terence Flynn: Your line is now open.
Terence Flynn: Thanks for taking the question. We're just wondering if you could speak to your confidence level in <unk> in the frontline non small cell lung trial setting here given the vocal one data and if you're considering any potential changes to that that frontline trial as a result, thank you.
Conversations with regulators outside the U S. And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
And then. We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Speaker Change: Alright tariff system.
Overall, what we've seen in <unk>, one and we're looking forward to sharing with you really maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Speaker Change: Yeah.
Speaker Change: I think when we have looked at the data so far and we're looking forward to sharing it with everyone.
Speaker Change: As we can.
Speaker Change: Probably one of the most important things in that data set that confirm.
Speaker Change: Where we were before is that we have not seen a difference in response rates between squame squamous cell carcinoma, and non squamous cell carcinoma, I think that was a bit of an overhang in the fall and as we had mentioned earlier, we have not seen that to date and that has been.
Our next question comes from the line of--yes, ma'am. Our next question comes from the line of Umer Raffat with Evercore. Your line is now open.
Yes, Ma'am. Our next question comes from the line of Omar Saad with Evercore. Your line is now open hi, guys. Thanks for taking hi. Guys. Thanks for taking my question. Look, it's very well understood for folks and Biopharma community that no one can truly understand the full safety profile of any new drug based on phase one data. And and but at this point has a lot of implications for your tax litigation. Obviously, so my question is in a scenario where the Supreme Court takes up of your petition would that potentially be a venue where you could prove the level of evidence that's actually needed to make a decision on exception to degree in the tablet decisions to make.
Yes, Ma'am. Our next question comes from the line of Omar Saad with Evercore. Your line is now open
Umer Raffat: Hi, guys, thanks for taking--hi, guys, thanks for taking my question. Look, it's very well understood for folks in biopharma community that no one can truly understand the full safety profile of any new drug based on Phase I data. But this point has a lot of implications for your tax litigation, obviously, so my question is, in a scenario where the Supreme Court takes up of your petition, would that potentially be a venue where you could prove the level of evidence that's actually needed to make a decision on exception [inaudible] decisions to make.
Your line is now open hi, guys. Thanks for taking hi.
Speaker Change: Bolstered by the results of the vote co. One so we do think that that.
Guys. Thanks for taking my question.
Look, it's very well understood for folks and Biopharma community that no one can truly understand the full safety profile of any new drug based on phase one data.
Speaker Change: Increases our confidence that we don't need to think about.
Speaker Change: Oh look at that now there are other analysis, we need to do to make sure that there are other there are other.
And and but at this point has a lot of implications for your tax litigation. Obviously, so my question is in a scenario where the Supreme Court takes up of your petition would that potentially be a venue where you could prove the level of evidence that's actually needed to make a decision on exception to degree in the tablet decisions to make.
Speaker Change: Predictors of response or not and we will be doing that and we'll be sharing that over time, but right now our overall confidence in <unk> broadly speaking remains very high we have three.
Speaker Change: Three approval.
Daniel O'Day: Alright I think Andy's going to take this one yes. Thanks for the question, Yes of course, I mean in front of the Supreme Court, just like the appellate court will be able to present.
Daniel O'Day: Alright I think Andy's going to take this one
Speaker Change: And we have a broad development program against which we are executing really well we continue to have additional trials that will read out this year.
Andrew D. Dickinson: Hi, Umer, yeah thanks for the question. Yes, of course, I mean in front of the Supreme Court, just like the appellate court, we'll be able to present the facts and our arguments as you'd expect. If you look at some of the briefing documents in the appellate court, I think they spell that out very clearly in terms of the, you know, what happens over time with the development of TAF and what we knew at different points in time, and that would be available as you would expect, not only to the appellate court, but to the Supreme Court, and of course those same facts would be presented at any trial, if we ever get to that point. One other update on the TAF litigation, again Umer nothing's changed from our perspective, we continue to have a lot of confidence. The one update I can provide is that the, one of the very first trial in the Federal Court has been dismissed as of yesterday, I believe, so it now looks like--and again, this is consistent as you know with the thousands of other cases, I think it's now over 5,300 cases that have been dismissed by the courts, over 4,300 in the California State Courts, and over 1,000 in the federal courts, before they get the trial. So the first bellwether trial in the federal courts, Umer, would now be in November instead of April. So, we'll keep you up to date and thanks for your question.
The facts that are in our arguments as you'd expect if you look at some of the briefing documents in the appellate court I think they spell that out very clearly in terms of the.
Speaker Change: Phase III.
Specifically the trophy of Trophy <unk> study that we'll be looking at the.
Speaker Change: Bladder cancer conformation study with hopefully an OS signal that study could.
You know what happens over time with the with the development of <unk> and what we knew at different points in time and that would be available as you would expect not only to the appellate court, but to the Supreme Court and of course those same the same facts would be presented at any trial, if we ever get to that point.
Speaker Change: Actually give us.
Speaker Change: <unk>.
Speaker Change: Confirmatory trial in the U S. It allows us to open.
Speaker Change: Conversations with regulators outside the U S and then we.
Speaker Change: We have promised an update on our center three in breast cancer, which we also think will broaden that and then we now have a number of trials going on in a variety of indications, including ones. We've mentioned for example, endometrial cancer. So overall, what we've seen in <unk>, one and we're looking forward to sharing with you really.
One other update on the <unk> litigation again nothing's changed from our perspective, we continue to have a lot of confidence.
The one update I can provide is that the.
One of the very first trial and the federal Court has been dismissed.
As of yesterday I believe so it now looks like and again. This is consistent as you know with the <unk>.
Speaker Change: It maintains our level of enthusiasm about <unk> long term potential from an efficacy and safety standpoint across the board and we have no plans to change it broker three at this time.
Thousands of other cases I think it's now over 5300 cases that had been dismissed by the courts over 4300 in the California State Court and over 1000 in the federal courts.
Speaker Change: Our next question comes from the line of.
Before they get the trial so the first bellwether trial in the federal courts tumor would now be in November instead of April. So, we'll keep you up to date and thanks for your question.
Speaker Change: Yes, Ma'am. Our next question comes from the line of Omar Saad with Evercore.
Omar Saad: Your line is now open hi, guys. Thanks for taking.
Omar Saad: Hi, guys. Thanks for taking my question.
Omar Saad: Look it's very well understood for folks in Biopharma community that no one can truly understand the full safety profile of any new drug based on phase one data.
Operator: Our next question comes from the line of Olivia Brayer with Cantor Fitzgerald. Your line is now open.
Olivia Brayer with Cantor Fitzgerald.
Your line is now open.
Omar Saad: And but at this point has a lot of implications for your tax litigation. Obviously, so my question is in the scenario, where the Supreme Court takes up your petition would that potentially be a venue where you could prove the level of evidence it's actually needed to make a decision on exception to degree in the tablet decisions to make.
Olivia Brayer: Hey, good afternoon, and thank you for the question. What were some of the dynamics that happened with Yescarta this quarter, and how should we be thinking about growth for 2024 from your cell therapy franchise, just in light of a sequentially down quarter in 4Q. Thanks.
Cindy Perettie: Thanks a lot, Olivia, for the question, this is Cindy. We continue to be the leaders in cell therapy, and I think the piece that Johanna mentioned is that we are looking at how do we expand beyond the existing ATCs. So the dynamics that we observed this quarter were capacity constraints within the existing agencies that we had, we saw a little bit of in class and out of class competition, and in parallel we have been continuing to work on expanding our ATCs. So today, we have over 400 ATCs globally. We are moving out of urban centers and those academic centers into the community to meet patients where they are. As Andy suggested, bringing up those ATCs in the community is going to be a really important part of our future strategy, but it does take a little bit longer than bringing an academic center up. So we expect to be flat to slightly up in quarter one, and you'll start to see that return to growth in the second half of the year.
Speaker Change: Alright again, he is going to take this one.
We. We need to be the leaders in cell therapy, and I think the piece that. As Johan mentioned is that we are looking at how do we expand beyond that there's still a T. C. So the dynamics that we observed this quarter or a catastrophe. Capacity constraints within the existing agencies that we had we saw a little bit of older class with other class competition. And in parallel we have been continuing to work on expanding our <unk>. So today, we have over 400 agencies globally. We are moving out of urban centers in those academic centers into the community to meet patients where they are as Andy suggested. Bringing those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center. So we expect to be flat to slightly up in quarter, one and you'll start to see that return to growth in the second half of the year.
We need to be the leaders in cell therapy, and I think the piece that. As Johan mentioned is that we are looking at how do we expand beyond that there's still a T. C. So the dynamics that we observed this quarter or a catastrophe. Capacity constraints within the existing agencies that we had we saw a little bit of older class with other class competition. And in parallel we have been continuing to work on expanding our <unk>. So today, we have over 400 agencies globally. We are moving out of urban centers in those academic centers into the community to meet patients where they are as Andy suggested. Bringing those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center. So we expect to be flat to slightly up in quarter, one and you'll start to see that return to growth in the second half of the year.
Speaker Change: Yes. Thanks for the question, Yes of course, I mean in front of the Supreme Court, just like the appellate court will be able to present.
As Johan mentioned is that we are looking at how do we expand beyond that there's still a T. C. So the dynamics that we observed this quarter or a catastrophe. Capacity constraints within the existing agencies that we had we saw a little bit of older class with other class competition. And in parallel we have been continuing to work on expanding our <unk>. So today, we have over 400 agencies globally. We are moving out of urban centers in those academic centers into the community to meet patients where they are as Andy suggested. Bringing those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center. So we expect to be flat to slightly up in quarter, one and you'll start to see that return to growth in the second half of the year.
Speaker Change: The facts that are in our arguments as you'd expect if you look at some of the briefing documents in the appellate court I think they spell that out very clearly in terms of the.
Capacity constraints within the existing agencies that we had we saw a little bit of older class with other class competition. And in parallel we have been continuing to work on expanding our <unk>. So today, we have over 400 agencies globally. We are moving out of urban centers in those academic centers into the community to meet patients where they are as Andy suggested. Bringing those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center. So we expect to be flat to slightly up in quarter, one and you'll start to see that return to growth in the second half of the year.
Speaker Change: What happens over time with the with the development of <unk> and what we knew at different points in time and that would be available as you would expect not only to the appellate court, but to the Supreme Court and of course those same.
And in parallel we have been continuing to work on expanding our <unk>. So today, we have over 400 agencies globally. We are moving out of urban centers in those academic centers into the community to meet patients where they are as Andy suggested. Bringing those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center. So we expect to be flat to slightly up in quarter, one and you'll start to see that return to growth in the second half of the year.
Speaker Change: Those same facts would be presented at any trial, if we ever get to that point.
Bringing those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing an academic center. So we expect to be flat to slightly up in quarter, one and you'll start to see that return to growth in the second half of the year.
Speaker Change: One other update on the top litigation again nothing's changed from our perspective, we continue to have a lot of confidence.
Speaker Change: One update I can provide is that the.
Speaker Change: One of the very first trial and the federal Court has been dismissed.
Speaker Change: As of yesterday I believe so it now looks like and again. This is consistent as you know with the <unk>.
Okay.
Operator: Our next question comes from the line of Geoff Meacham with Bank of America. Your line is now open.
Speaker Change: Thousands of other cases I think it's now over 5300 cases that had been dismissed by the court over 4300 in the California State Court.
Bank of America. Your line is now open.
Geoff Meacham: Great, thank you. I have another one on cell therapy, but more on the profitability. This is a franchise that's almost $2 billion in sales, you guys have improved the turnaround time, you've reached scale, you've treated a ton of patients. What can you tell us about the progress that you've made to make this a profitable franchise, I'm just thinking not for the current products, but also looking out five years plus. Thank you.
Speaker Change: 1000, and the federal courts.
You have another one on cell therapy, but more.
Speaker Change: Before they get the trials. So the first bellwether trial in the Federal Court tumor would now be in November instead of April. So, we'll keep you up to date.
More on the profitability.
Our franchise, that's almost $2 billion in sales you guys have improved the turnaround time, you reach scale, you've created a ton of patients.
Speaker Change: For your question.
What can you what can you tell us about the progress that you've made to make them.
Speaker Change: Our next question comes from the line.
A profitable franchise I'm, just thinking but not for the current products, but also looking out five years plus thank you.
Speaker Change: Olivia Brayer with Cantor Fitzgerald.
Olivia Brayer: Your line is now open.
Olivia Brayer: Hey, good afternoon, and thank you for the question what were some of the dynamics that happened with NASCAR to this quarter and how should we be thinking about growth for 2024 from your cell therapy franchise, just in light of a sequentially down quarter in <unk>. Thanks.
Andrew D. Dickinson: Hey, Jeff, it's Andy, thanks for the question. It's a great question, you're absolutely right. The cell therapy business has made tremendous progress over the last five or six years, and evidenced most recently by the faster turnaround time in manufacturing that we talked about in our prepared remarks, going from 16 days for 14 days, and again, it's just the beginning from our perspective of what we can continue to do with this business. So while we don't provide specific guidance, we have said when we announced the Kite transaction that we expect it to be profitable, breakeven or profitable and accretive by the end of year four, we got there shortly after that. All of the metrics that we look at on the business have improved over time, we've continued to make significant progress on our manufacturing efficiencies, manufacturing costs. Despite the fact that we've opened three global manufacturing centers and each time you do that, when you move the commercial manufacturing, it impacts your gross margin. So I'm really proud of what the team has done. And same thing on the operating costs. You see in the fourth quarter, we announced some restructuring charges, Geoff, that hit our GAAP results. Part of that was a restructuring at Kite; Cindy and her team looked at the structure and made changes to the structure that we think will continue to drive growth and efficiency in the business over the long run. 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. We're really growing the business, Geoff, as you know, for long term sustainability and growth in less near term profitability, but its certainly exciting that the business is doing as well as it is. I think the only thing I would add to <unk> comment is beyond just the three manufacturing facilities. We also have our own viral vector facilities. So given the fact that viral vector has had some supply challenges that's something that we are not suffering from so we only sort of end to end cost of goods for our products.
Andrew D. Dickinson: Hey, Jeff, it's Andy, thanks for the question. It's a great question, you're absolutely right. The cell therapy business has made tremendous progress over the last five or six years, and evidenced most recently by the faster turnaround time in manufacturing that we talked about in our prepared remarks, going from 16 days for 14 days, and again, it's just the beginning from our perspective of what we can continue to do with this business. So while we don't provide specific guidance, we have said when we announced the Kite transaction that we expect it to be profitable, breakeven or profitable and accretive by the end of year four, we got there shortly after that. All of the metrics that we look at on the business have improved over time, we've continued to make significant progress on our manufacturing efficiencies, manufacturing costs. Despite the fact that we've opened three global manufacturing centers and each time you do that, when you move the commercial manufacturing, it impacts your gross margin. So I'm really proud of what the team has done. And same thing on the operating costs. You see in the fourth quarter, we announced some restructuring charges, Geoff, that hit our GAAP results. Part of that was a restructuring at Kite; Cindy and her team looked at the structure and made changes to the structure that we think will continue to drive growth and efficiency in the business over the long run. 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. We're really growing the business, Geoff, as you know, for long term sustainability and growth in less near term profitability, but its certainly exciting that the business is doing as well as it is.
Evidenced most recently by the the.
Speaker Change: Thanks, a lot Olivia for questions.
The faster turnaround time in manufacturing that we talked about on our prepared remarks going from 16 days for 14 days and again, it's just the beginning from our perspective of what we can continue to do with this business. So while we don't provide specific.
Olivia Brayer: Okay.
Olivia Brayer: We continue to be the leaders in cell therapy, and I think the piece that Johanna mentioned is that we are looking at how do we expand on the distillate <unk>.
Olivia Brayer: The dynamics that we observed this quarter.
Guidance, we've had we have said when we announced the transaction that we expect it to be profitable breakeven or profitable and accretive by by the end of year four we got there shortly after that.
Olivia Brayer: Capacity constraints within the existing licensees that we had we saw a little bit of older class with other class competition.
Olivia Brayer: And in parallel we have been continuing to work on expanding our <unk>. So today, we have over 400 agencies globally. We are moving out of urban centers in those academic centers into the community to meet patients where they are as Andy suggested.
All of the metrics that we look out on the business have improved over time, we've continued to make significant progress on our manufacturing efficiencies manufacturing costs. Despite the fact that we've opened three global manufacturing centers and each time, you do that when you move the commercial manufacturing it impacts your gross margin. So I'm really proud of what the team has done.
Olivia Brayer: That brings up those agencies in the community is going to be really important part of our future strategy, but it does take a little bit longer than bringing in academic centers. So we expect to be flat to slightly up in quarter, one and youll start to see that return to growth in the second half of the year.
And same thing on the operating costs you see in the fourth quarter, we announced some restructuring charges, Jeff that hit our gaps.
Our GAAP results part of that was a.
Restructuring type of city and her team looked at at the structure and made changes to the structure that we think will continue to drive growth and efficiency in the business over the long run. So maybe the last thing I'd say is that when we look at the business. As a business that we have line of sight to biologics margins and profitability, we're really growing the business, Jeff as you know for long term sustainability and growth in less near term profitability, but its certainly exciting that that the business is doing as well as it is I think the only thing I would add to <unk> comment is beyond just the three manufacturing facilities. We also have our own viral vector facilities. So given the fact that viral vector has had some supply challenges that's something that we are not suffering from so we only sort of end to end cost of goods for our products.
Olivia Brayer: Okay.
Olivia Brayer: Our next question comes from the line of Geoff Meacham.
Geoff Meacham: Bank of America. Your line is now open.
Geoff Meacham: Yes.
Geoff Meacham: Thank you.
As a business that we have line of sight to biologics margins and profitability, we're really growing the business, Jeff as you know for long term sustainability and growth in less near term profitability, but its certainly exciting that that the business is doing as well as it is I think the only thing I would add to <unk> comment is beyond just the three manufacturing facilities. We also have our own viral vector facilities. So given the fact that viral vector has had some supply challenges that's something that we are not suffering from so we only sort of end to end cost of goods for our products.
Geoff Meacham: I have another one on cell therapy, but.
Geoff Meacham: More on the profitability.
Geoff Meacham: Our franchise, that's almost $2 billion in sales you guys have improved the turnaround time.
Geoff Meacham: Reached scale, you've treated a ton of patients you know.
Cindy Perettie: I think the only thing I would add to Andy's comment is beyond those three manufacturing facilities, we also have our own viral vector facilities. So given the fact that viral vector has had some supply challenges, that's something that we are not suffering from, so we own the sort of end-to-end cost of goods for our products.
What can you what can you tell us about the progress that you've made to making the.
Speaker Change: A profitable franchise I'm, just thinking not for the current products, but also looking out five years plus thank you.
We also have our own viral vector facilities. So given the fact that viral vector has had some supply challenges that's something that we are not suffering from so we only sort of end to end cost of goods for our products.
Speaker Change: Hey, Jeff It's Andy Thanks for the question. It's a great question, you're absolutely right. The cell therapy business has made tremendous progress over the last five or six years and.
Jackie Ross: May we have our next question, please, Victoria.
Of course, our next question comes from the line of Michael Yee with Jefferies. Your line is now open hey, guys. Thanks.
Operator: Of course, our next question comes from the line of Michael Yee with Jefferies. Your line is now open.
Andy: Evidenced most recently by the <unk>.
Your line is now open hey, guys. Thanks.
Andy: The faster turnaround time in manufacturing that we've talked about on our prepared remarks.
Michael Yee: Hey, guys. Thanks, thank you for the question. We had an HIV question; there were some comments around the dynamics of the channel mix as it relates to HIV pricing, and I was wondering if you could just remind us about what the driver of the benefit was in '22 and '23, and how that changed as we go into '24 and why that's [inaudible]. Is that a change in mix between commercial and Medicaid swapping, or maybe just explain that. That would help us understand what's going on there for '24. Thank you.
Thank you for the question.
We have the HIV question there were some comments around the dynamics of the channel mix as it relates to HIV depressed pricing and I was wondering if you could just remind us about what the driver of the benefit was in 'twenty, two and 'twenty three and how that changed as we go into 'twenty four and why that's difficult comps is that a.
Andy: Going from 60 days to 14 days and again, it's just the beginning from our perspective of what we can continue to do with this business. So while we don't provide specific.
Andy: Guidance, we've had we have said when we announced the kite transaction that we expect it to be profitable breakeven or profitable and accretive by by the end of year four we got there shortly after that.
Change in mix between commercial and Medicaid Schwab.
Andy: All of the metrics that we look at it on the business have improved over time, we've continued to make significant progress on our manufacturing efficiency manufacturing costs. Despite the fact that we've opened three global manufacturing centers and each time, you do that when you move the commercial manufacturing it impacts your gross margin. So I'm really proud of what the team has done.
Swapping or maybe just explain that that would help us understand what's going on there for 24. Thank you.
Johanna Mercier: Sure, Michael. Hi, it's Johanna, let me take that one. So what you're referring to is actually we saw some pricing favorability in Q4 of '22 in the first half of 2023. That pricing favorability was mainly driven by actually just the inflation being so high and therefore some of our rebates are actually based on that inflation rate, and so therefore there was actually upside during those quarters. We knew that that was not going to repeat itself, so we had kind of shared with you I think from Q3 on that this was going to normalize, and so that was kind of what happened in the first half of 2023. As we think about the second half of 2023, and namely the fourth quarter, what we did see there was very strong demand and that continued throughout the whole year, but we had some fluctuations, some quarterly variability, mainly due to channel mix, and more government channels resulting in lower average realized price because of higher rebates. And so you really have to look at it on a full year basis, and so that's why it's so important to know that HIV performance will always have some quarterly variabilities, and we always need to look at the full year to really get the full picture of what's going on. HIV for the full year of 2023 grew 6%, with nearly $1 billion dollars in revenue growth driven by the Biktarvy, obviously growing at 14%, and at 48% share with 3% share growth in that year, outpacing all competitors. And so we're really proud of the demand driven results that we've seen in 2023, and as we think about 2024 and our predictions for '24, we believe that our expectation is going to be inline with HIV treatment, which is still about two to three points. Layer on top of that the demand growth from Biktarvy and Descovy for PrEP, and that's why we'r eexpecting about a 4% growth in HIV. So that gives you the full picture of what's going on and what happened in the past, so we don't expect that on a yearly basis, but on a quarterly basis, we do expect that variability and I would expect that that will continue as we move forward.
So what you're referring to is actually we've got some pricing favorability in Q4 of 22 in the first half of 2023.
That pricing favorability with mainly driven by actually just the inflation being so high and therefore.
Andy: And same thing on the operating costs you see in the in the fourth quarter, we announced some restructuring charges, Jeff that hit our GAAP.
Some of our rebates are actually based on that inflation rate and so therefore, there was absolutely upside during those quarters, we knew that that was not going to repeat itself or we had.
Andy: Our GAAP results part of that was a.
Andy: Restructuring Cindy and her team looked at at the structure and made changes to the structure that we think will continue to drive growth and efficiency in the business over the long run. 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.
Kind of shared with you I think from Q3 on that because it's going to normalize and so that was kind of what happened in the first half of 2023 as we think about the second half of 2023 and mainly to the fourth quarter. We did see very very strong demand and that continued throughout the whole year, but we had some flux.
Cindy Peretti: We're really growing the business, Jeff as you know for long term sustainability and growth in less near term profitability, but its certainly exciting that that the business is doing as well as it is I think the only thing I would add to <unk> comment is beyond just the three manufacturing facilities. We also have our own viral vector facility. So given the fact that viral vector has had.
<unk> quarterly variability, mainly due to channel mix.
And more government channels, resulting in lower average realized price because of higher rebates and so you really have to look at it on a full year basis and so that's why it's so important to know that HIV performance on it and we will always have some quarterly variability and we always need to look at the full year to really get the full picture of what's going on HIV for the full year of 2023.
Cindy Peretti: The supply challenges, that's something that we are not suffering from that we only sort of end to end cost of goods for our products.
Speaker Change: And we have our next question please.
6% with nearly $1 billion in revenue growth driven by the entirety, obviously growing at 14% and at 48% share with 3% share growth in that year outpacing our competitors and so we're really proud of the demand driven.
Speaker Change: Of course, our next question comes from the line of Michael Yee with Jefferies.
Michael J. Yee: Your line is now open hey, guys. Thanks.
Michael J. Yee: Thank you for the question.
Michael J. Yee: We have the HIV question there were some comments around the dynamics of the channel mix as it relates to HIV depressed pricing.
Now that we've seen in 2023 and as we think about 2024 and our predictions for 'twenty four we believe that our expectation it's going to be inline with HIV treatment, which is still about two to three points layer on top of that the demand growth into <unk> and discovery for profit and not fiber expecting about.
Michael J. Yee: I was wondering if you could just remind us about what the driver of the benefit was in 'twenty, two and 'twenty three and how that changed as we go into 'twenty four and why that's difficult comps is that a change in mix between commercial and Medicaid.
Michael J. Yee: Swapping or maybe just explain that that would help us understand what's going on there for 24. Thank you.
A 4% growth in HIV. So that gives you the full picture of what's going on and what happened in the past or we don't expect them that on a yearly basis, but on a quarterly basis, we do expect that variability and I would expect that that will continue as we move forward.
Speaker Change: Sure Michael highest Joanna let me take that line.
Speaker Change: So what you are referring to is actually we've got some pricing favorability in Q4 of 'twenty two in the first half of 2023 and.
That pricing favorability, Rick mainly driven by actually just been placing being so high and therefore.
Operator: Our next question comes from the line of Chris Schott with JP Morgan. Your line is now open.
Your line is now open.
Speaker Change: Some of our rebates are actually based on that inflation rate and so therefore, there was absolutely upside during those quarters, we knew that that was not going to repeat itself that we had.
Chris Schott: Great. Thanks so much for the question. Can you just talk about the TIGIT program and what drove the decision to step up your investments here, and maybe as part of that can you elaborate a little bit more on the decision to deemphasize the PD-L1 high population in favor of the all comers study, so any color there would be appreciated. Thank you.
Speaker Change: <unk> shared with you I think from Q3 on that this is going to normalize and so that was kind of what.
Speaker Change: What happened in the first half of 2023, as we think about the second half of 2023 and mainly to the fourth quarter. We did see very very strong demand and that continued throughout the whole year, but we had some fluctuations in quarterly variability mainly due to channel mix.
The all comer study I'm, sorry, any color there would be appreciated. Thank you.
Andrew D. Dickinson: Hey, Chris, it's Andy. Maybe I'll start on the TIGIT program and the revised agreement with Arcus that we announced last week, and then Merdad can answer the second part of your question. It's relatively simple, if you step back, you've heard us say this before, but I would reiterate that we value the partnership that we have with Arcus and the programs that their team has developed, and the recent updates, to your question, to the partnership really allow both companies to more efficiently deploy our teams and capital. We also focused on streamlining decision making, and the additional capital allows us to expand the overall clinical study footprint. So there are number of things that both companies accomplish through the amendment. It does reinforce our support and belief in their programs broadly, not just TIGIT, but there's a lot to be excited about there that you'll see play out over the coming years.
Then mehrdad can answer the second part of your question.
Yes, it's relatively simple if you step back we you've heard US say this before but I would reiterate that we value. The partnership that we have with ARCUS and in the programs that their team has developed and the recent updates to your question to the partnership really allow both companies to more efficiently deploy our teams in capital. We also focused on streamlining decision making.
Speaker Change: And more government channels, resulting in lower average realized price because of higher rebates and so you really have to look at it on a full year basis and so that's why it's so important to know that HIV performance on it we'll always have some quarterly variability and we always need to look at the full year to really get the full picture of what's going on HIV for the full year of 2023.
And the additional capital allows us to expand the overall clinical study footprint. So there are number of things that both companies accomplish through the through the amendment it does reinforce our support.
Speaker Change: 6% with nearly a $1 billion in revenue growth driven by the entirety, obviously growing at 14% and at 48% share with 3% share growth in that year outpacing our competitors and so we're really proud of the demand driven.
And belief in their programs broadly not just <unk>, but there's a lot to be excited about there that you'll you'll see play out over the coming years.
Speaker Change: Results that we've seen in 2023 and as we think about 2024 and our predictions for 'twenty four we believe that.
Merdad V. Parsey: And, excuse me, this is Merdad. I think you're referring to the ARC-10 study, and as you may recall, we started that study together with Arcus back in 2021 outside the US, with a chemo comparator arm, and at the time, there was really limited access to PD-1, PD-L1 inhibitors outside the US, and so we subsequently updated that study March of last year to include PD-L1 inhibitors as the standard of care was evolving. It took us time to get this all going, and while that was happening, we had a number of competitors launch similar trials in the space with their TIGIT antibodies. So as a result of all that, the enrollment for the ARC-10 trial wasn't as robust as we had hoped for, and as it had been, and STAR-121, which is the all comers study, was recruiting very well and so we decided to really prioritize our efforts for that all comers population where we think we could be first or second in class, and it was really a prioritization to ensure that we can stay ahead and keep moving the molecule forward as quickly as possible.
I think you're referring to the Ark 10 study and as you May recall, we started that study together with ARCUS back in 2021 outside the U S with a with a chemo comparator arm and at the time, there was really limited access to PD, one PDL one inhibitors outside the U S and so we subsequently.
Speaker Change: Our expectation it's going to be.
Speaker Change: In line, Rick HIV treatment, which is still about two to three points layer on top of that the demand growth from Nick Harvey and discovery for prep and that's why we're expecting about a 4% growth in HIV. So that gives you the full picture of what's going on and what happened in the past and we don't expect.
That steady March of last year to include PDL, one inhibitors as a standard of care was evolving.
Speaker Change: That on a yearly basis, but on a quarterly basis, we do expect that variability and I would expect that that will continue as we move forward.
It took us time to get this all going and.
While that was happening we had a number of competitors launch similar trials.
Speaker Change: Our next question comes from the line of Chris Schott with Jpmorgan. Your line is now open.
In this space with their tissue antibodies. So as a result of all that new enrollment for the our 10 <unk> wasn't as robust as we had hoped for and as it had been and star $1 21, which is the all commerce study.
Chris Schott: Great. Thanks, so much for the question can you just talk about the <unk> program and what drove the decision to step up your investments here and maybe as part of that can you elaborate a little bit more on the decision to deemphasize. The PD Lone high population is in favor of the all comer study. So any color there would be appreciated. Thank you.
<unk> was recruiting very well and so we decided to really prioritize our efforts for that all comers.
Population, where.
Where we think we could be first or second in class and it was really a prioritization to ensure that we can stay ahead and keep moving the molecule forward as quickly as possible.
Chris Schott: Hey, Chris It's Andy maybe I'll start on the ticket program in the the revised agreement with ARCUS that we announced last week and then <unk> can answer the second part of your question.
Operator: Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.
Andy: Yes. It is relatively simple if you step back we you've heard US say this before but I would reiterate that we value. The partnership that we have with ARCUS and the programs that their team has developed.
Brian Abrahams: Hi, good afternoon. Thanks so much for taking my question. I realize this is a pending KOL and regulatory discussions, but I was wondering if you could frame the potential next steps for the PD-L1 poor responders. Do you think this is a fileable population for Trodelvy and second line lung, or might you also consider running another study in that population. And along those lines, I'm curious what you are expecting to see from the updated EVOKE-02 data this year and how that might shape your overall plans for Trodelvy in lung.
Realize this is a pending kols and regulatory discussions, but I was wondering if you could frame the potential next steps for the PD Lone poor responders do you think this is a viable population unfortunate el being second line longer but you also consider running another study in that population and along those lines I'm curious what you are expecting to see from the updated.
Andy: And the recent updates to your question to the partnership really allow both companies to more efficiently deploy our teams in capital. We also focused on streamlining decision making.
Andy: And the additional capital allows us to expand the overall clinical study footprint. So there are a number of things that both companies accomplish through the through the amendment it does reinforce our support.
Oh, two data this year and how that might shape. Your overall plans for <unk> in lung.
Andy: And belief and their programs broadly not just ticket.
Andy: Theres a lot to be excited about there that you'll see play out over the coming years.
Merdad V. Parsey: Sure, this is Merdad again, Brian, so maybe I'll take the second part first. On EVOKE-02, as you can imagine we showed last year ORR data, and those data are going to continue to mature as time goes by, so we should start to see more PFS data this year that will demonstrate, we hope continued confidence in the frontline setting for Trodelvy based on that study that's running in parallel with EVOKE-03. So we've gotten a lot of confidence from EVOKE-02 to support 03, and so we are going to keep updating that to make sure we get that, and it does actually reflect back on one of the earlier questions around changes to EVOKE-03 and EVOKE-02 really keeps us in the right population, gathering data so that we can make sure that there no changes that are necessary. In terms of the PD-1 non-responders in EVOKE-01, I think we need more time to study the data and we need to talk to the KOLs and the regulators to see there's, I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data, and I want to be realistic and say that a second trial, another trial, may be necessary and something that we would, we are thinking about right now, and we'll let you know as we update our situation there. And of course, we'll share the data from EVOKE-01 so that we can talk about it in more detail over time.
Speaker Change: And excuse me if this is Mary.
As you can imagine we showed last year or our data and those data are going to continue to mature as time goes by so we should start to see more. First data this year that will demonstrate. Demonstrate we hope. Confidence in the frontline setting for <unk>. Based on that study that's running in parallel with <unk> three so. We had we've gotten a lot of confidence from a broker to to support three and so we are we. We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Mary: I think you're referring to the art 10 study and.
Mary: As you May recall, we started that study together with ARCUS back in 2021 outside the U S with a with a chemo comparator arm and at the time, there was really limited access to PD, one PDL one inhibitors outside the U S and so we subsequently updated that steady March of last year to include PDL, one inhibitors as a standard.
First data this year that will demonstrate. Demonstrate we hope. Confidence in the frontline setting for <unk>. Based on that study that's running in parallel with <unk> three so. We had we've gotten a lot of confidence from a broker to to support three and so we are we. We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Demonstrate we hope. Confidence in the frontline setting for <unk>. Based on that study that's running in parallel with <unk> three so. We had we've gotten a lot of confidence from a broker to to support three and so we are we. We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Confidence in the frontline setting for <unk>. Based on that study that's running in parallel with <unk> three so. We had we've gotten a lot of confidence from a broker to to support three and so we are we. We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Based on that study that's running in parallel with <unk> three so. We had we've gotten a lot of confidence from a broker to to support three and so we are we. We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
We had we've gotten a lot of confidence from a broker to to support three and so we are we. We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Mary: <unk> evolving.
Mary: It took us time to get this ongoing and.
Mary: While that was happening we had a number of competitors launch similar trials.
We are going. Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Trying to keep updating that to make sure we get that and it does actually reflect back on one of the earlier questions around changes to Volcker three Annabel go to really keeps us in the right population. Okay gathering data. So that we can make sure that there no changes that are necessary. In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Mary: In this space with their <unk> antibody. So as a result of all of that enrollment for our <unk> wasn't as robust as I said.
Mary: We had hoped for and as it had been and star $1 21, which is the all commerce study.
Mary: Was recruiting very well and so we decided to really prioritize our efforts for that all comers.
In terms of the. PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
PD one. Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Non responders. Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Mary: Population.
Evoke a one. I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Mary: Where we think we could be first or second in class and it was really a prioritization to ensure that we can stay ahead and keep moving the molecule forward as quickly as possible.
I think we need more time to study the data and we need to talk to the Kols and the regulators to see there is I wouldn't rule out the possibility that we could discuss with regulators the possibility of using these data and they wanted to be realistic and say that. Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Mary: Our next question comes from the line of Brian Abrahams with RBC capital markets. Your line is now open.
Brian Abrahams: Hi, good afternoon. Thanks, so much for taking my question.
Second trial, another trial, maybe necessary and something that we would. We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
Brian Abrahams: Realize this is a pending kols and regulatory discussions, but I was wondering if you could frame the potential next steps for the PD Lone poor responders do you think this is a viable population. Unfortunately, all being second line longer but you also consider running another study in that population and along those lines I'm curious what you are expecting to see from the updated.
We are thinking about right now and we'll let you know as we update our situation there. And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
And of course, we'll share the data from a vocal one. So that we can talk about it in more detail over time.
So that we can talk about it in more detail over time.
Operator: Our next question--our final question comes from the line of Colin Bristow with UBS.
Brian Abrahams: Oh, two data this year and how that might shape. Your overall plans for <unk> in lung.
Colin Nigel Bristow: Afternoon, and thanks for squeezing me in. Can you hear me? Maybe on the back of Brian's question, with regards to the observation that [inaudible] benefit was greatest in those non responsive to prior IO in the EVOKE-01 study; appears to align with a recent study which showed that TROP2 expression levels are associated with primary resistance to checkpoint inhibition in non small cell patients and so, and from that obviously raises the question on the potential synergy of TROP2 and anti-PD-1s. I wondered if you had any thoughts on this, or do you have any data, which kind of gives you comfort. Thanks.
With me in. Can you hear me. Can you maybe. Ryan's question maybe. Maybe on the back of Brian's question would have gone to the observation that this benefit was greatest in those non responsive to prior. One study this seems to align with a recent study which showed the trop two expression levels are associated with the primary resistance to checkpoint inhibition. Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Can you hear me. Can you maybe. Ryan's question maybe. Maybe on the back of Brian's question would have gone to the observation that this benefit was greatest in those non responsive to prior. One study this seems to align with a recent study which showed the trop two expression levels are associated with the primary resistance to checkpoint inhibition. Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Brian Abrahams: Okay.
Brian Abrahams: Sure. This is Matt again, Brian So maybe I'll take the second part first on a bogo two.
Can you maybe. Ryan's question maybe. Maybe on the back of Brian's question would have gone to the observation that this benefit was greatest in those non responsive to prior. One study this seems to align with a recent study which showed the trop two expression levels are associated with the primary resistance to checkpoint inhibition. Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Ryan's question maybe. Maybe on the back of Brian's question would have gone to the observation that this benefit was greatest in those non responsive to prior. One study this seems to align with a recent study which showed the trop two expression levels are associated with the primary resistance to checkpoint inhibition. Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Maybe on the back of Brian's question would have gone to the observation that this benefit was greatest in those non responsive to prior. One study this seems to align with a recent study which showed the trop two expression levels are associated with the primary resistance to checkpoint inhibition. Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Matt: As you can imagine we showed last year or our data and.
One study this seems to align with a recent study which showed the trop two expression levels are associated with the primary resistance to checkpoint inhibition. Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Small cell patients and so. Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Yes. And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
And from that obviously raises the question on the potential synergies. <unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
<unk>, an anti PD ones I wondered if you had any thoughts on this or do you have any data, which kind of gives you comfort.
Merdad V. Parsey: We've spoken about this before, it's definitely something that we are cognizant of and following. One of the data readouts that we are continuing to collect right now from EVOKE-01 is TROP2 expression, and I think that will help us as we look at those data and share them to formulating hypotheses that may warrant changes. So TROP2 expression is definitely something that we are focused on and will continue to follow and evaluate. Thank you. I would now like to pass the conference back to Daniel for any closing remarks.
Merdad V. Parsey: We've spoken about this before, it's definitely something that we are cognizant of and following. One of the data readouts that we are continuing to collect right now from EVOKE-01 is TROP2 expression, and I think that will help us as we look at those data and share them to formulating hypotheses that may warrant changes. So TROP2 expression is definitely something that we are focused on and will continue to follow and evaluate.
One of the.
Data Readouts that we are continuing to collect right now from Nabucco. One is trop two expression and I think that will help us.
As we look at those data and share them to formulating hypotheses that may. Warrant changes so it's that trop two expression is definitely. Something that we are focused on and will continue to follow and evaluate.
Warrant changes so it's that trop two expression is definitely. Something that we are focused on and will continue to follow and evaluate.
Something that we are focused on and will continue to follow and evaluate.
Operator: Thank you. I would now like to pass the conference back to Daniel for any closing remarks.
Thank you I would now like to pass the conference back to Daniel for any closing remarks.
Daniel O'Day: Well thanks, everyone for joining we very much appreciate it. Before we conclude the call, let me just wrap up with a couple of comments in summary from what the team has accomplished over the past year and are set up for '24. First, our full year performance reinforces the continued growth and strength of the business. Gilead's HIV portfolio is unmatched with the standard of care daily oral treatment, and our rapidly advancing pipeline with potentially best in class long acting regimens. And in oncology, we now have a business that is annualizing at over $3 billion dollars with clear opportunity for future growth. So that's the base business last year-this year, and second, our strong business allows us to take bold bets in innovation, and you'll see multiple updates on how those are playing out in 2024 and beyond. We're pursuing science with a high potential impact for patients, and that comes with risk, but importantly, we have built a resilient business and a robust portfolio that allows for that. In 2024, we expect at least 20 key updates across our HIV and oncology portfolios. And finally, I just want to thank the Gilead teams for all the hard work in delivering our strong full year performance and advancing our portfolio. We look forward to keeping all of you updated on our progress throughout 2024, thanks again for joining today.
First our full year performance reinforces the continued growth and strength of the business Gilead HIV portfolio is unmatched with the standard of care daily oral treatment and our rapidly advancing pipeline with potentially best in class long acting regimens and in oncology. We now have a business that is annualizing at over $3 billion. With a clear opportunity for future growth. So that's the base business last year this year and second our strong business allows us to take bold bets in innovation and you'll see multiple updates on how those are playing out in 2024 and beyond for pursuant science with a high potential impact for patients and that comes with risk, but importantly, we have built a resilient. <unk> business and a robust portfolio that allows for that in 2024, we expect at least 20 key updates across our HIV and oncology portfolios and finally I just want to thank the gilead teams for all the hard work in delivering our strong full year performance and advancing our portfolio we have. Look forward to keeping all of you updated on our progress throughout 2024, thanks again for joining today.
With a clear opportunity for future growth. So that's the base business last year this year and second our strong business allows us to take bold bets in innovation and you'll see multiple updates on how those are playing out in 2024 and beyond for pursuant science with a high potential impact for patients and that comes with risk, but importantly, we have built a resilient. <unk> business and a robust portfolio that allows for that in 2024, we expect at least 20 key updates across our HIV and oncology portfolios and finally I just want to thank the gilead teams for all the hard work in delivering our strong full year performance and advancing our portfolio we have. Look forward to keeping all of you updated on our progress throughout 2024, thanks again for joining today.
So that's the base business last year this year and second our strong business allows us to take bold bets in innovation and you'll see multiple updates on how those are playing out in 2024 and beyond for pursuant science with a high potential impact for patients and that comes with risk, but importantly, we have built a resilient. <unk> business and a robust portfolio that allows for that in 2024, we expect at least 20 key updates across our HIV and oncology portfolios and finally I just want to thank the gilead teams for all the hard work in delivering our strong full year performance and advancing our portfolio we have. Look forward to keeping all of you updated on our progress throughout 2024, thanks again for joining today.
<unk> business and a robust portfolio that allows for that in 2024, we expect at least 20 key updates across our HIV and oncology portfolios and finally I just want to thank the gilead teams for all the hard work in delivering our strong full year performance and advancing our portfolio we have. Look forward to keeping all of you updated on our progress throughout 2024, thanks again for joining today.
Look forward to keeping all of you updated on our progress throughout 2024, thanks again for joining today.
Operator: That concludes today's call. Thank you for your participation and enjoy the rest of your day.