Johanna Mercier
Chief Commercial Officer at Gilead Sciences
Thanks, Dan, and good afternoon, everyone.
It was another strong quarter of commercial execution across the business, and I'm proud of the work the teams continue to do to expand the reach of our medicines to many more people and patients around the world.
As shown on Slide 8, total product sales, excluding Veklury, were $6.8 billion in the third quarter, up 7% year-over-year, reflecting strong growth across HIV, oncology and liver disease. Including Veklury, total product sales were $7.5 billion, up 7% year-over-year.
Starting with HIV on Slide 9, sales of $5.1 billion were up 9% year-over-year and 7% sequentially, primarily driven by higher average realized price due to shifts in channel mix and higher demand across treatment and PrEP. The third quarter once again demonstrated the quarterly pricing variability we see in HIV. Specifically, we saw adjustments to government channels, where there is a multi-quarter lag for certain claims data. As a result, the quarter reflected more favorable average realized pricing. Year-to-date, HIV sales have grown 5%, well above our prior full-year growth target of 4%. With that outperformance in mind, we're increasing our full-year HIV growth expectation to 5%, and we remind you to focus on full-year versus quarterly trends. To that end, for the fourth quarter, in particular, we expect HIV sales to be roughly flat quarter-over-quarter, with continued demand growth and modest seasonal inventory build, offset by the third quarter pricing dynamics discussed earlier that are not expected to repeat.
Turning to Slide 10. Biktarvy third quarter sales of $3.5 billion increased 13% year-over-year, driven by higher demand as well as higher average realized price due to shifts in channel mix, partially offset by inventory dynamics. Sequentially, sales were up 7%, primarily driven by channel mix and higher demand. In the U.S. and across major markets, Biktarvy continues to be the regimen of choice for those starting treatment and switching therapies, and has grown for 25 consecutive quarters. In the U.S., Biktarvy's share grew to over 49%, up more than 2% year-over-year and remains the leading regimen for HIV treatment. Gilead is well-positioned to maintain its leadership in the HIV treatment market with four new regimens by the end of 2030. Overall, the HIV treatment market continues to grow in-line with our expectations of 2% to 3% annually.
Moving to Descovy, third quarter sales were $586 million, up 15% year-over-year, reflecting higher demand and average realized price due to channel mix, partially offset by inventory dynamics. Sequentially, sales were up 21%, primarily driven by channel mix and higher demand. The U.S. PrEP market continues to demonstrate robust growth, up 13% year-over-year and Descovy for PrEP remains the leading branded option, capturing over 40% market share despite the availability of generics and other regimens. Overall, Descovy for PrEP sales make up an increasing portion of total Descovy sales, representing roughly 80% in the third quarter. This is a strong foundation as we prepare for the first anticipated commercial launch of lenacapavir for PrEP next year. Lenacapavir's remarkable clinical profile and unmatched twice yearly administration offer the potential to redefine the HIV prevention market and we look forward to sharing more details on our commercialization plans and treatment programs at our HIV Analyst event in December.
In the meantime, we look to file for approval in the U.S. before the end of the year and are well underway with our preparations for the first commercial launch in 2025. In addition to our commercial plans, we're particularly proud of our commitment to make lenacapavir available in 120 high-incidence, resource-limited countries as quickly as possible, ensuring access for lenacapavir for PrEP is made as broadly available upon approval.
Moving to the liver disease portfolio on Slide 11. Sales of $733 million in the third quarter were up 4% year-over-year, driven by increased demand across our viral hepatitis portfolio, partially offset by pricing dynamics, including shifts in channel mix in the U.S. Sequentially, after an incredibly strong second quarter, sales declined 12%, primarily driven by inventory dynamics and fewer patient starts in HCV.
Turning to Slide 12, in mid-August, we launched Livdelzi in the U.S. for PBC, with the first prescription written within a few hours of the accelerated approval. Furthermore, with 100% of our U.S. commercial organization trained by the time of launch, we quickly reached more than 1,000 of our target prescribers within the first several weeks. Overall, we're very encouraged with the patient demand we're seeing so far, which is ahead of our internal expectations. We believe this reflects the differentiated profile of Livdelzi as the only approved therapy with statistically significant improvements in both ALP and pruritus as well as an established safety profile. Sales in the third quarter were modest, as we expected, in the low-single-digit millions and reflective of the ramp-up time required to onboard patients and providers and to work through step edits and prior authorizations that are normal for a rare disease launch. We expect to start building momentum as we enter 2025 when we look to a more meaningful sales contribution. Outside the U.S., launch preparations are ongoing and we look forward to the European regulatory decision in early 2025.
Moving to Slide 13. Veklury has continued to remain the antiviral standard of care for hospitalized patients treated for COVID-19, including in the U.S., with more than 60% share in this setting. Altogether, with higher than expected hospitalizations in the summer months, sales in the third quarter were up 9% year-over-year to $692 million. Year-to-date sales of $1.5 billion are now well ahead of our initial full-year guidance of $1.3 billion. As a result, we're raising our full-year guidance for Veklury to approximately $1.8 billion.
Now, turning to oncology on Slide 14, Gilead and Kite therapies have treated more than 65,000 patients globally, highlighting our continued growing reach. Sales for the quarter were $816 million, up 6% year-over-year, primarily driven by Trodelvy growth. Sequentially, oncology sales were down 3%, with growth in Trodelvy offset by a decline in cell therapy.
Beginning with Trodelvy on Slide 15. Sales of $332 million were up 17% year-over-year and 4% quarter-over-quarter, reflecting higher demand in all regions. In breast cancer, Trodelvy remains well-positioned as the only approved and commercially available Trop-2 directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancers. Notably, Trodelvy is the standard of care for second-line metastatic triple-negative breast cancer, with ongoing adoption in the pre-treated HR+/HER2- metastatic breast cancer setting. We're pleased to see both indications contribute to Trodelvy's growth year-over-year despite an evolving competitive landscape.
Turning to Slide 16, and on behalf of Cindy and the Kite team, cell therapy sales of $485 million in the third quarter were flat year-over-year, with strong 23% growth outside the U.S., offset by the U.S. Sequentially, total cell therapy sales were down 7% due to competitive headwinds, both in and out of class, in the U.S., which we expect to continue into 2025. As a pioneer in cell therapy, Kite's focus is to expand overall utilization and increase class share. As part of this work, we're partnering with government agencies and healthcare associations to amplify education of the benefits of CAR-T and remove barriers to access. To date, only two of every 10 eligible patients receive CAR-T in second-line plus large B-cell lymphoma in the U.S., and we are committed to removing these barriers, so we can deliver potentially curative therapies like Yescarta to more patients.
In the community setting, Kite is leading the way in identifying and lowering barriers and building the right ecosystem to enable more people to receive CAR-T beyond the reach of an academic medical institution. Today, CAR-T sites often need to be accredited typically by the Foundation for the Accreditation of Cellular Therapy, or FACT, and this requirement has been highlighted as a hurdle for our community partners to achieve national payer reimbursement. In the meantime, we're pleased to share that we have treated our first few patients as part of our community strategy, demonstrating that we can deliver Yescarta in this setting.
Outside the U.S., we saw year-over-year demand growth as we continue to expand into the second-line relapsed or refractory large B-cell lymphoma setting in Europe and launch in new markets. In particular, we're encouraged by our progress in Japan, where we have onboarded more than 50 authorized treatment centers in little over a year with more to come in the near future.
Overall, I would like to thank the commercialization teams for their hard work to deliver another strong quarter and first nine months of the year. With launch activities underway in PBC and for HIV prevention launch next year, our teams are excited to bring our transformative medicines to many more people and patients globally.
And with that, I'll hand the call over to Merdad.
