Johanna Mercier
Chief Commercial Officer at Gilead Sciences
Thanks, Dan, and good afternoon, everyone.
Before discussing our commercial results, I want to acknowledge our Gilead team for delivering another outstanding quarter and closing out a very successful year. 2022 was an exceptional year for Gilead, with our virology franchise well positioned to continue its leadership for years to come and significant progress in executing our oncology strategy, and bringing new medicines to improve the lives of more patients all around the world.
Starting on Slide 7. We had a very strong quarter, delivering a total product sales, excluding Biktarvy of $6.3 billion, up 9% year-over-year or 12% excluding the impact of FX and the loss of exclusivity of Truvada and Atripla with solid growth in each of our core franchises and growth across all geographies, once again, led by HIV and oncology. Quarter-over-quarter, sales grew 5%, driven by HIV, Trodelvy and cell therapy, partially offset by HCV.
For the full year, total product sales, excluding Biktarvy were $23.1 billion, up 8% year-over-year or 11% excluding the impact of FX and the Truvada Tripla LOE, driven by HIV and oncology. As expected, full year Biktarvy sales were down meaningfully in 2022 compared to 2021. That said, Biktarvy's performance has been more sustainable than we previously expected and it's clear that it continues to play an essential role for hospitalized patients treated for COVID-19. In 2022, Biktarvy delivered $3.9 billion, including $1 billion in the fourth quarter. Overall, full year total product sales of $27 billion was flat compared to 2021 as growth in our base business was offset by the decline in Biktarvy sale.
On Slide 8, HIV sales for the fourth quarter were $4.8 billion, up 5% year-over-year, driven by higher demand as well as favorable pricing dynamics. This was offset in part by a smaller than usual inventory build in the fourth quarter, reflecting our early efforts on seasonal inventory management. Sequentially, HIV sales in the fourth quarter were up 6%, primarily driven by favorable pricing and inventory dynamics as well as higher demand.
For the full year, HIV sales of $17.2 billion were up 5% year-over-year due to higher demand, primarily related to the continued strength of Biktarvy in addition to channel mix leading to higher average realized price. This was partially offset by inventory dynamics and FX. Overall, the HIV treatment market in the fourth quarter grew 1.5% year-over-year in the U.S. and over 2% in Europe. On an annual basis, the market has grown in line with our expectations of 2% to 3%.
Moving to prevention. The U.S. PrEP market grew 18% year-over-year and 3% sequentially in the fourth quarter of 2022, reflecting growing awareness. Descovy sales for the fourth quarter were $537 million, up 13% year-over-year and 7% sequentially. Notably, despite generics and other entrants, demand for Descovy for PrEP continues to increase, up more than 20% for the full year in addition to maintaining a stable market share of over 40%. With these trends and the TAF IP settlement last year, Descovy position in the growing PrEP market has only strengthened. Overall, this provides a strong foundation as we look to the potential launch of lenacapavir for PrEP as a true long-acting every six-month regimen in the middle part of the decade.
Moving to Trodelvy on Slide 9. Sales for the quarter were $2.9 billion, up 15% year-over-year, primarily driven by higher demand as well as favorable pricing dynamics offset in part by lower channel inventory. Quarter-over-quarter, sales were up 6% similarly driven by higher demand as well as favorable pricing and inventory dynamics. In every quarter since our launch, we've seen Biktarvy continue to gain market share and the fourth quarter was no exception, getting more than 3 percentage points in share year-over-year. This continued momentum is a testament to the Biktarvy's differentiated clinical profile, reinforced by the long-term five-year data we presented last year. Notably, in the U.S., Europe and other major markets, Biktarvy remains the number one regimen for new starts, in addition to its number one position in treatment switches across most of the major markets, including the U.S.
At the end of 2022, there are almost 1 million people managing their HIV with Biktarvy worldwide. Taken all together, this has led Biktarvy for the first time to achieve full year sales of over $10 billion in 2022. Looking ahead, we're confident that Biktarvy will remain the leading medicine for the treatment of HIV in the U.S., Europe and other major markets for years to come.
Now looking ahead for the first quarter of 2023 for HIV, a few points I just wanted to call out. First, with respect to pricing dynamics, as we enter the new year, we expect the typical first quarter reset in patient co-pay and deductible. As always, these will have an unfavorable impact on average realized price in the first quarter; second, a reminder that we've historically seen inventory buildup in Q4 that has led to notable drawdown by wholesalers in Q1.
While we've implemented new processes to better manage inventory dynamics from the fourth quarter into the first quarter, we continue to expect an inventory drawdown to occur in Q1, albeit at more modest levels compared to prior year. So with this in mind, we expect HIV sales for the first quarter to decline by low teens sequentially from the fourth quarter. This compares to the 18% sequential decline we reported in the first quarter of 2022. For the full year 2023, I'd like to remind you that some of our HIV performance in '22 was driven by shift in channel mix that had a favorable impact on average realized price, contributing in part to the 5% year-over-year revenue growth we reported in 2022.
We expect channel mix in 2023 to be relatively similar to last year, and therefore, do not expect HIV growth to benefit from changes in average realized price like we saw in 2022. As a result, we continue to expect HIV to grow in 2023, albeit at a modestly lower growth rate than 2022.
As we think about the future of the HIV market, Gilead is well positioned to provide many people living with HIV and those at risk of HIV with multiple options for care. To that end, we're excited about the recent approvals for Sunlenca in the U.S. and Europe for heavily treatment-experienced adults with multidrug-resistant HIV infection. This first indication represents only 1% to 2% of people living with HIV, there's a huge unmet medical need. These individuals have cycled through multiple antiretroviral regimen and until now, have had very few, if any, effective options left available.
Sunlenca is now approved in the U.S., U.K. and European markets, and we're working as quickly as possible with regulators and reimbursement bodies to make Sunlenca available in many more countries. We believe this first launch of Sunlenca represents a key milestone for Gilead and looking forward in the treatment and potential prevention of HIV. With Sunlenca, a true acting regimen is a reality. As awareness and familiarity of Sunlenca's every six-months subcutaneous administration grow among health care providers, community groups and people living with and at risk of HIV, we believe Sunlenca is well positioned for the future.
Turning to HCV on Slide 10. Sales for the fourth quarter were $439 million, up 12% year-over-year, reflecting timing of Department of Corrections or DOC purchases and favorable pricing dynamics in the U.S. Quarter-over-quarter, HCV sales were down 16%, primarily due to resolution of a rebate claim in Europe in the third quarter of 2022 that did not repeat as well as other pricing dynamics in the U.S., offset in part by timing of DOC purchases. Going forward, we continue to expect new starts to decline, but are encouraged that our market share remains over 50% in both U.S. and Europe.
Sales of HBV and HDV for the fourth quarter were $255 million, as shown on Slide 11. Sales were down 4% year-over-year and down 3% sequentially, primarily due to lower vanity demand and pricing dynamics outside of the U.S.
Moving to Biktarvy on Slide 12. Sales for the fourth quarter were $1 billion with a full year totaling $3.9 billion. It's clear that as the pandemic has evolved, Biktarvy's will in the treatment of COVID-19 has remained unchanged as a key part of the standard of care for hospitalized patients. In fact, Biktarvy is still the only antiviral approved in this setting. And in the U.S., Biktarvy continues to be used in over 50% of hospitalized patients who are being treated for COVID-19. We're excited to continue to work on our oral COVID-19 nucleoside, which Merdad will discuss shortly.
Moving to oncology and beginning with Trodelvy Slide 13. Sales of $195 million in the fourth quarter grew 65% year-over-year and 8% sequentially. For the full year, Trodelvy sales were $680 million, up 79% year-over-year. As we continue to broaden access to Trodelvy around the world, we're encouraged by the growing demand in existing markets. Trodelvy is now reimbursed across the major European markets. And in the U.S., demand was up 13% quarter-over-quarter. Our growth rate almost doubled from the prior quarter, reflecting the solid contribution of our expanded field force and growing awareness.
We're also excited by the expected decision from the FDA later this month, which could expand Trodelvy's potentially clinically meaningful benefit into the pretreated HR-positive HER2-negative metastatic breast cancer setting. We estimate this represents at least 6,000 addressable patients in the U.S., and our U.S. field force has just wrapped up its launch meeting and is energized for the upcoming approval. The opportunity for Trodelvy to benefit patients with pretreated HR-positive HER2-negative metastatic disease is supported by the recent NCCN Category 1 preferred recommendation for Trodelvy based on the TROPiCS-02 data. Additionally, the European Medicines Agency recently validated our marketing authorization application for Trodelvy in HR-positive HER2-negative and we look forward to a decision later this year.
Now on to Slide 14 and on behalf of Kristie and the Kite team, Cell Therapy sales in the fourth quarter were $419 million, up 75% year-over-year and 5% sequentially. Full year cell therapy sales were $1.5 billion, up 68% year-over-year. The growth in the fourth quarter and full year were driven by continued uptake of Yescarta in large B-cell lymphoma, notably in the U.S. Growing physician familiarity with Yescarta data and Kite's industry-leading manufacturing continue to be key growth drivers.
Yescarta sales was $337 million, up 85% compared to the fourth quarter of 2021 and 6% sequentially. We're pleased to see not only strong momentum in second-line LBCL in the U.S. but also continued uptake in third-line LBCL in both the U.S. and across European markets. Tecartus sales were $82 million in the fourth quarter, up 2% quarter-over-quarter with growing volume demand in both mantle cell lymphoma and adult acute lymphoblastic leukemia. Year-over-year, Tecartus sales were up 44%. We're pleased to see the building momentum of CAR-T cell therapy as a treatment class with curative potential and Yescarta and Tecartus as the leading cell therapies of choice globally. More patients are getting access due to Kite's industry-leading reliable manufacturing capabilities and the team's expanding footprint of authorized treatment centers around the world.
And just last week, U.K.'s National Institute for Health and Care Excellence, or NICE, recommended Yescarta for routing use in third-line large B-cell lymphoma. This makes Yescarta the first CAR-T available for commissioning in England. Approvals and reimbursement into additional indications that are currently available in the U.S., the other markets is expected to continue over the next year. Yescarta was recently approved for second-line LBCL in Japan, which has the potential to be the second largest cell therapy market outside of the U.S., and we look forward to the transfer of the Marketing Authorization to Gilead and Kite later this year.
In the interim, although still early days, we'll continue to work with our partner Daiichi Sankyo to make Yescarta available to approximately 7,000 patients in the second-line plus setting. Kite will begin manufacturing supply for the Japanese market through our El Segundo, California facility.
And with that, I'll hand the call over to Merdad for an update on our pipeline. Merdad?
