Lilly's under-pressure Trulicity scores with first-of-its-kind cardio outcomes win

Eli Lilly's Trulicity is facing down Novo Nordisk newcomer Ozempic in the market. (Eli Lilly)

All eyes are on Eli Lilly’s Trulicity as it faces down some hefty new competition from diabetes rival Novo Nordisk. But the Indianapolis drugmaker just notched an important trial win that shows it can hang with its rival.

Monday, the pharma giant said that in a cardiovascular outcomes trial, Trulicity showed it could significantly cut down the combined rate of heart attack, stroke and cardiovascular death. It’s not the first drug to gain that distinction; fellow Lilly drug, SGLT2 Jardiance, grabbed that title in 2015, and since then plenty of other diabetes products—including Novo's blockbuster GLP-1 Victoza and newer entrant semaglutide—have done the same.

Trulicity, though, is the first to demonstrate a reduction in a trial that included a majority of participants—about 69%—without already established cardiovascular disease, which “could help Trulicity differentiate” from other drugs’ outcomes studies, Credit Suisse analyst Vamil Divan wrote to clients.

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It’s an important score for Trulicity, which is facing off against new competition from Novo Nordisk. The Danish drugmaker is already in the process of launching Ozempic, a long-acting GLP-1 drug. But it’s also prepping for an even bigger opportunity—a different, oral formulation of Ozempic, known as semaglutide, that’s already posted a raft of positive phase 3 data.

“This is clearly positive news and should ease concerns about Trulicity's ability to compete in the rapidly-growing GLP-1 market,” Divan wrote. Evercore ISI analyst Umer Raffat noted that investors had been “very skeptical” about the trial, particularly because semaglutide showed no benefit in the subgroup of patients without prior CV events.

While details on the victory will be under wraps until June’s American Diabetes Association Scientific Sessions, the way Raffat sees it, the results are likely pretty strong. “On efficacy hazard ratio, I doubt Lilly would have used the word ‘compelling’ without the HR being at least in the semaglutide-like range at least,” he wrote, noting that that drug reduced the risk of major cardiovascular events by 26% in a trial dubbed Sustain-6.

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The thing is, the data won’t necessarily move the needle in terms of analyst estimates for sales, which have gone from $3 billion to a consensus peak of about $5 billion already, Raffat pointed out. “We think of this as a GLP-1 franchise estimate now … which in the long run means a switch” to Lilly’s next-gen GIP and GLP-1 receptor agonist.

“However,” he added, “this is a nice positive for stock and sentiment.”