Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antiviral franchise with an eye on the potential of its long-acting HIV med lenacapavir.
But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter earnings report.
Gilead’s once fast-growing cell therapy products have hit a wall as of late with relatively flat sales all year. Over the third quarter, lymphoma treatment Yescarta saw revenue dip 1% to $387 million compared to last year’s third quarter, while its Tecartus counterpart similarly remained flat with 2% growth to $98 million.
Gilead attributed the Yescarta challenges to “increased in- and out-of-class competition” in the U.S., slightly offset by increased demand in relapsed or refractory large B-cell lymphoma (LBCL) in other regions. In terms of the outside competition, one notable rival includes Bristol Myers Squibb’s rival CD19 CAR-T Breyanzi.
BMS’ offering joined Yescarta in second-line LBCL in 2022 and followed up with approvals in follicular lymphoma and mantle cell lymphoma in May.
Unlike Yescarta, Breyanzi has been pulling strong growth with a third-quarter year-over-year sales bump of 143%, driven mainly by the two new indications, BMS’ chief financial officer David Elkins said on the company’s recent earnings call.
But despite the threats from bispecifics and other CAR-Ts like Breyanzi, Gilead isn’t looking to pivot its strategy, head of the company’s Kite cell therapy unit Cindy Perettie clarified on the earnings call.
“I think in the oncology space, when new therapies get approved in new indications, it's very common for physicians to try out the new therapies,” Perettie noted. “We're continuing to focus on driving both our class share and our brand share, and feel very confident in the plans that we have to date to continue our expansion into the community and elsewhere.”
A new CAR-T could join the fold come 2026, when the company and partner Arcellx hope to market their anitocabtagene autoleucel (anito-cel). The therapy recently delivered a win in relapsed or refractory multiple myeloma after overcoming trial concerns last year that included a patient death.
With all of Gilead’s learnings from its two marketed cell therapies, antio-cell production for study usage is already looking similar to its commercial turnaround times, and the company doesn’t have “any concerns about our ability to scale,” Perettie said.
Meanwhile for antibody-drug conjugate Trodelvy, which rounds out Gilead’s oncology portfolio, a removal of the second-line non-small cell lung cancer opportunity prompted a third-quarter impairment charge of $1.75 billion from the drug's carrying value. The company picked up Trodelvy from its $21 billion Immunomedics buyout in 2020. Following a phase 3 flop, Gilead in April wrote $2.4 billion off the drug's value because of a "smaller addressable market" in second-line-plus NSCLC and delayed launch timing.
Last month, Trodelvy’s bladder cancer ambitions were also derailed after Gilead decided to officially withdraw the treatment in that indication following a May miss in a confirmatory study.
Trodelvy hit year-over-year sales growth of 17% during the third quarter due to higher demand “across all regions” in its existing breast cancer indications. But its modest 4% sequential growth got Leerink Partners analysts thinking that the drug is "likely approaching its peak potential" in second-line triple-negative breast cancer, according to a Thursday note.
Outside of oncology, the company has all eyes on its newest HIV drug, lenacapivir. While the long-acting med is already approved for multidrug-resistant HIV, Gilead is positioning it as a market-changing pre-exposure prophylaxis (or PrEP) option, and its commercialization plans are already “well underway,” chief commercial officer Johanna Mercier noted.
“We’re leaders today in HIV, both across treatment and prevention,” Mercier said. “The intent is to continue to remain leaders for the future.”
Gilead’s HIV sector, populated by dominant HIV treatment Biktarvy and PrEP Descovy, contributed $5.1 billion to the company’s total quarterly sales haul of $7.5 billion, reflecting growth of 7% year-over-year.
Gilead’s third-quarter haul beat analysts' expectations by 8% mainly thanks to severe COVID-19 treatment Veklury, according to Leerink. Veklury enjoyed a 9% sales growth after several quarters of sharp declines, adding to an industry-wide trend of renewed growth in long-fading COVID products. Due to increased COVID rates in the U.S., the drug brought in $692 million, coming 139% ahead of Wall Street's consensus estimate.