Eli Lilly: Capacity and access key to launching Mounjaro outside US

Eli Lilly expects to double incretin capacity by the end of 2023, driving the launch of once-weekly type 2 diabetes medication Mounjaro (tirzepatide) beyond the US.

Type 2 diabetes medication Mounjaro received US Food and Drug Administration (FDA) in May 2022 and pulled in $187 million in its first full quarter, and a further $279.2 in Lilly’s Q4.

The once-weekly drug consisting of incretin hormones GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) is an expected blockbuster so long as Lilly can ensure supply keeps up with demand, both in the US and globally.

Image: DepositPhotos/
designer491

With major CAPEX projects in Research Triangle Park (RTP) and Concord (both North Carolina) underway, management has previously predicted to see a substantial production ramp up in 2025.

But speaking at the SVB Securities Global Biopharma Conference last week, Lilly president Ilya Yuffa gave investors and expectant patients more color, saying the firm expects to double its incretin capacity by the end of 2023.

“RTP is probably that next step-up in node of capacity, and we’re making great progress in RTP,” he said, alluding to the $470 million expansion that began in 2020. “We expect to meet our goal of expanding capacity and doubling by the end of the year. That allows us to – even with the momentum we’re seeing in the US – to allow for launches outside of the US.”

As such, the firm anticipates launching Mounjaro in Japan in H1, with other international launches occurring throughout the year.

However, Yuffa said “it takes time to build up access and reimbursement” in these markets, thus the firm is working on this in parallel to the new capacity coming online.

“Depending on the market, [there is] a nine to 12-month lag from approval to access. And so we’re continuing those discussions in those markets so that when we have the ability to trigger a launch, based on capacity, we’re ready for it, both in reimbursement and also supply.”

SVB analyst David Risinger pushed Yuffa for more comment on the manufacturing situation.

“The manufacturing team have done a phenomenal job to actually deliver over what they’ve planned in our current nodes of capacity,” said Yuffa.

“We talk about doubling by the end of this year, but we’ve also announced investments in expanding RTP, so multiple lines in RTP. We also announced and already started developing our site in Concord. And so additional investments also in Indiana and nearing in Ireland as well. And so we have a strategy to expand capacity over time to meet the demand. So that’s an important aspect is that we’re not just settling for the first node of capacity.”