Johanna Mercier
Chief Commercial Officer at Gilead Sciences
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, reflecting solid base business growth with total product sales excluding Veklury up 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, reflecting the uptick in hospitalizations at the end of 2023, though still below levels seen in 2022.
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 price in addition to the expected decline of our portfolio of non-promoted products.
Moving to slide 10. 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 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. 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 U.S. This growth, once again, outpaced all other branded regimens for HIV treatment and represented the 22nd quarter of consecutive year-over-year share gain.
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 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 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 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 sub-channel 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. 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% to 3%, Biktarvy 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 built up in the fourth quarter that has led to notable drawdowns 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.
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. 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 HCV, we continue to reinforce Gilead's leadership with market share of over 60% in the U.S. 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.
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-related hospitalizations in the fourth quarter. For the full year, Veklury sales of $2.2 billion exceeded the expectations we set out at the beginning of 2023.
Turning to slide 15. 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, Trodelvy revenue has grown to more than $1 billion, and we continue to see strong growth across our approved indication. 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.
Looking more closely at Trodelvy 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. With over 30,000 patients treated to date, Trodelvy's solid demand trends continue to reinforce its robust clinical profile as the only Trop-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 Trodelvy, reinforcing its position as the leading regimen across the U.S. and other major markets. In pretreated HER+/HER2- metastatic breast cancer, we're encouraged to see shared growth overall, driven by increasing adoption in the IHC 0 setting, as well as continued use in HER2-low. Additionally, we look forward to potentially making Trodelvy more broadly available in metastatic bladder cancer. Data from the confirmatory phase 3 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 Trodelvy'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 Kite team, 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. 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 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 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, CAR T class share in this same second-line plus setting continues to be stronger at approximately 30%.
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 U.S. 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 U.S. 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 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.
