Johanna Mercier
Chief Commercial Officer at Gilead Sciences
Thanks Dan and good afternoon, everyone. Before I jump into the commercial results for the third quarter, I wanted to begin by acknowledging our teams for another exceptional quarter. We're making important progress in our goals of ensuring the strength and sustainability of our virology franchise, while also continuing to build our expertise and market presence in oncology.
Turning to Slide 7, we had a very strong quarter with total product sales excluding Veklury of $6.1 billion, up 11% year-over-year, or 15% excluding FX and the residual impact of the HIV LOEs, with growth in each of our core franchise areas and notable strength in HIV and oncology. Sequentially, total product sales excluding Veklury grew 6%, driven by HIV, HCV and oncology. Growth excluding FX impact and the LOEs was 8%.
On Slide 8, HIV sales of $4.5 billion were up 7% year-over-year. Excluding the impact of both FX and the LOEs, HIV revenue grew 10% year-over-year. Similar to last quarter, this was primarily channel mix driven by U.S. government utilization leading to higher average realized price, in addition to higher demand. Overall, despite the quarter-over-quarter shifts in average realized price, government plans continue to represent approximately 60% of our U.S. HIV treatment prescriptions, including Medicare in the low-20s. HIV revenue growth was driven by the U.S., while Europe was down year-over-year, due to FX and less favorable pricing dynamics, offset in part by higher demand. Quarter-over-quarter, HIV sales were up 6%, similarly driven by channel mix and inventory dynamics, as well as higher demand.
Turning to the market more broadly, we are encouraged that on a year-over-year basis, the HIV treatment market across the U.S. and Europe has grown for five consecutive quarters. This reflects the work we have been doing with our partners to bring people living with HIV and people at risk of HIV back into care following the pandemic. The market growth we are seeing suggests that activity has returned to pre-COVID trends. In the third quarter of 2022, the market grew 2% year-over-year both in the U.S. and Europe.
Looking forward, we continue to expect annual treatment market growth in the 2% to 3% range. Descovy sales were $500 million, up 16% year-over-year and 9% sequentially and PrEP market share remains stable despite generic and other entrants. For the quarter, the PrEP market continues to demonstrate robust growth, largely driven by the growing awareness for PrEP and demand well-above pre-pandemic levels. Overall, the PrEP market grew 19% year-over-year and 6% sequentially.
Onto Slide 9. Third quarter Biktarvy sales were $2.8 billion, up 22% year-over-year, driven by higher demand in both the U.S. and Europe and favorable pricing dynamics. Sequentially, sales were up 8%, due to higher demand as well as favorable inventory and pricing dynamics. Once again, Biktarvy continues to command a leading position in the treatment of HIV, with another record quarter growing to 45% market share in the U.S., up 4 percentage points year-over-year. Moreover, Biktarvy remains the leading medicine for those seeking to switch to a new regimen in the U.S. as well as those starting treatment in both the U.S. and Europe, most notably, capturing 10 new starts for every 1 person prescribed another medicine in the U.S.
Looking to the fourth quarter, I'd like to call out a few points. First, given the historic trend towards a significant inventory build in the fourth quarter followed by inventory draw down in the first quarter, we are renewing our focus on inventory management in an effort to better align the timing of product delivery with end-user demand. Second, while we continue to see strong market share gains for Biktarvy in addition to solid growth in both the treatment and prevention markets, we will remind you that some of our second and third quarter performance has been driven by shifts in channel mix that have had a favorable impact on average realized price.
Given the favorable trends we observed over the last two quarters we do expect the channel mix to be more stable in the fourth quarter. With these factors in mind and also allowing for further FX impact, we expect fourth quarter HIV sales to be roughly flat on a sequential basis, noting that full year 2022 HIV growth is therefore expected to be approximately 4%, or 7% excluding the LOEs and FX headwinds year to date.
In summary, we're extremely proud of the portfolio we have built in HIV and excited about the way Gilead is positioned for 2023 and beyond. Specifically, Biktarvy's clinical profile continues to impress, evidenced by ongoing, strong growth rates even though its annual revenue run rate is now in excess of $10 billion. Descovy for PrEP, maintained over 40% market share despite competition and generic entrants. And most recently lenacapavir's approval as Sunlenca for heavily treatment experienced people living with multi-drug resistant HIV in the EU. This is an important option for a group that has few treatment options and is a great opportunity for physicians and the HIV community to get more familiar with a six monthly, subcutaneous HIV therapy. We believe this sets the stage well for our other planned lenacapavir-based treatment and prevention regimens.
All of this, combined with, the treatment and prevention markets showing solid recovery; the impact of the loss of exclusivity of Truvada and Atripla now behind us; and the recent TAF settlement extending projected U.S. LOEs for Descovy and Odefsey into the early 2030s and Genvoya's patent to 2029 in the U.S. All of this truly underpins our confidence that Gilead is well-positioned for growth and continued leadership in the HIV market.
Now, onto Slide 10. HCV sales for the third quarter were $524 million, up 22% year-over-year and 17% sequentially, primarily due to the favorable resolution of a prior year rebate claim in Europe and other favorable pricing dynamics in the U.S. Offsetting these benefits, there were fewer patient starts in both the U.S. and Europe, consistent with our expectations for both the quarter and the general trend that you should expect in HCV going forward. Despite the trend in patients starts, we're pleased to maintain HCV market share of more than 50% in both the U.S. and Europe and third quarter share increased on a year-over-year basis.
For HBV and HDV on Slide 11, sales were up 7% year-over-year and 13% quarter-over-quarter, primarily driven by favorable inventory dynamics.
Moving to Veklury on Slide 12, third quarter revenues were $925 million. As expected, sales were down year-over-year given lower U.S. hospitalizations as compared to the same period last year. Indeed, though hospitalizations are below the peak seen at the start of the year, it's clear with the sequential increase that the path of the pandemic remains difficult to predict. Nonetheless, we're proud of the role Veklury continues to play in the fight against COVID-19. In the U.S., Veklury is used in approximately 60% of hospitalized patients who are being treated for COVID. And outside the U.S., Veklury's benefit to patients continues to be recognized by health authorities including the World Health Organization and the European Medicines Agency, based in part on the PINETREE data which demonstrated a significant reduction in the risk of hospitalization after a three-day IV treatment in the outpatient setting. These factors continue to support Veklury utilization where it is needed.
Moving to Oncology and beginning with Trodelvy on Slide 13. Sales of $180 million grew 78% year- over-year and 13% quarter-over quarter and we continue to work with regulators, payers and clinicians around the world to broaden access. Since its approval in second line metastatic TNBC late last year in Europe, Trodelvy is now reimbursed in 13 countries outside the U.S., with additional markets in Europe and elsewhere expected to come on line shortly. We've also begun work on establishing the right infrastructure to support a potential launch into pretreated HR-positive/HER2-negative metastatic breast cancer. Reinforcing the significant unmet need in this population and the clinically meaningful overall survival data demonstrated in the Phase 3 TROPiCS-02 study, FDA has accepted our supplemental Biologics License Application as Priority Review and we look to a decision in February of next year. We're excited by the potential for many more patients to benefit from Trodelvy.
Now onto Slide 14 and on behalf of Christi and the Kite team, I'm pleased to share that Cell Therapy sales in the third quarter were $398 million, up 79% year-over-year and up 8% sequentially. These strong results were driven by continued growth in large B-cell lymphoma and Kite's ability to reliably meet customer demand. Together with our recently FDA-approved viral vector manufacturing facility in Oceanside, Kite remains well-positioned to ensure clinical and commercial supply availability while it continues to execute on its geographic expansion.
For the quarter, Yescarta sales of $317 million were up 81% year-over-year and 8% quarter-over- quarter, driven by a continued successful launch in second-line LBCL in the U.S. and partially offset by FX headwinds in Europe. Just last week, Yescarta was approved in the EU for second-line LBCL and we look forward to launching there in the months ahead.
Tecartus grew 72% year-over-year to deliver $81 million in sales, driven by growth in adult acute lymphoblastic leukemia. In early September, the European Marketing Authorization for Tecartus in relapsed or refractory ALL was granted. We continue to broaden awareness and access to our cell therapies through indication and Authorized Treatment Center expansion in existing markets as well as through geographic expansion, as demonstrated by our most recent regulatory applications in Brazil, Singapore and Saudi Arabia. As always, Christi is available for Q&A later on the call.
Overall, this was an incredibly strong quarter for Gilead oncology, with revenue of $578 million up 10% from last quarter and 79% from last year. This represents an almost $2.4 billion annual run rate as we move into the last few months of 2022 and hints at the possibilities ahead as we continue to execute on our commercial and clinical oncology goals.
And with that, I'll hand the call over to Merdad for an update on our pipeline.