While a glut of drugmakers have raised their 2024 financial guidance after the second quarter, those upgraded sales expectations pale in comparison to Eli Lilly’s new forecast for the year.
Lilly, which reported a 36% year-over-year sales increase to $11.3 billion in the second quarter, is raising its guidance for the full year by a staggering $3 billion. All told, the company now expects to rake in sales between $45.5 billion and $46.6 billion in 2024, according to a Thursday release.
Lilly says it’s raising its outlook thanks to the strong performance of its dual GIP/GLP-1 meds for diabetes and obesity, Mounjaro and Zepbound—though the company’s suite of non-incretin medicines is expected to chip in, too.
What’s more, Lilly says it now has “improved clarity” on the timing and pace of its production expansions and planned Mounjaro launches outside the United States. The drugmaker knocked out several supply-related milestones in 2024’s second quarter and has “increased confidence” in its production expectations for the rest of the year, Lilly said in its earnings release.
Earlier this month, all doses of Mounjaro and Zepbound were listed as available on the FDA’s online database of drug shortages. The supply update came after nearly all doses of the sister medicines were placed on the agency’s shortage list in April. The Type 2 diabetes drug Mounjaro has struggled with supply constraints going all the way back to 2022.
The supply squeeze, which has largely been blamed on the intense mainstream popularity of Lilly’s drugs—plus their Novo Nordisk rivals Ozempic and Wegovy—has prompted Lilly to pour billions into extra supply capacity over the last few years.
"Mounjaro, Zepbound and Verzenio led our strong financial performance in the second quarter as we advanced our manufacturing expansion agenda, and it is equally exciting to see the growth around the world of our medicines for cancer, neurological disorders and autoimmune diseases," Lilly’s CEO, David Ricks, said in a statement.
As it stands, Lilly’s “top priority” continues to be the execution of its “ambitious manufacturing agenda,” Ricks said on a call with analysts Thursday. As part of that production campaign, the CEO pointed to Lilly’s recent $5.3 billion investment in its Lebanon, Indiana, plant, which has raised Lilly’s total outlay at the site to $9 billion.
“We believe this is the largest single investment in synthetic medicine active pharmaceutical ingredient manufacturing in the history of the United States,” Ricks said, reaffirming that the project will help add capacity to manufacture ingredients for Mounjaro and Zepbound.
Since 2020, Lilly has committed more than $18 billion to build, upgrade or acquire production facilities in Europe and the U.S., Ricks pointed out.
The CEO also flagged additional efforts to ramp up production at new and existing sites as well as through its partnerships with contract manufacturers.
As for the up-and-coming plant at North Carolina’s Research Triangle Park, Lilly expects production to kick off by the end of 2024, with product ready to ship from the site in 2025, Ricks said.
Even though supplies of Mounjaro and Zepbound have “come into better balance,” Lilly noted in its release that expected demand increases could fuel “periodic supply tightness” for certain formats and doses of the drugs. The company says it plans to launch 2.5 mg and 5 mg vials of Zepbound “in the coming weeks.”
For the second three months of the year, Mounjaro brought home $3.09 billion in sales, up about threefold from the $979.7 million the drug generated over the same stretch in 2023. Zepbound, for its part, generated $1.24 billion in the second quarter. Zepbound was first approved in Nov. of 2023.
Aside from sales figures, Lilly’s Q2 earnings handily beat consensus estimates by $1.31 per share, Lee Brown, global sector lead for Healthcare at research firm Third Bridge, wrote in a note to clients. Brown credited that performance to the “explosive growth” of both Mounjaro and Zepbound while noting that Verzenio shouldn’t go unappreciated, either.
Brown also pointed out that tirzepatide—the molecule that underpins Mounjaro and Zepbound—has several significant expansion opportunities on the horizon.
Of note, Lilly showed last week in a phase 3 trial that tirzepatide reduced the risk of adverse heart failure outcomes by 38% compared to placebo. The company plans to submit tirzepatide's heart failure results to the FDA and other regulators "starting later this year," the company said at the time.
That should give the company a head start against Novo Nordisk, which yesterday announced that it pulled its U.S. filing in heart failure for the obesity med Wegovy. Novo now plans to resubmit its application in early 2025.