Eli Lilly and Company (NYSE:LLY) Q3 2023 Earnings Call Transcript

We think that what’s incredibly important in the field, is that good correlative data, particularly with amyloid PET, which is the gold standard in diagnosis is published and shared so that we can continue to make sure that we have high quality tests out there. So that’s part of our goal with delivering this test is to really set a standard for what blood tests should look like. So look forward to hearing more over the next coming months as we publish that data and then make that more broadly available.

Joe Fletcher: Thanks, Anne, and thanks Mohit for the question, Paul, next question.

Operator: The next question is coming from Louise Chen from Cantor, Louise your line is live.

Louise Chen: Hi, thanks for taking my question. So I want to ask you, do you think the approval of additional oral potential — approval of additional oral diabetes drug could impact the pricing for injectables? Why or why not? Thank you.

Joe Fletcher: Thanks, Louise, for the question. I’ll hand over to Mike about the potential approval for other oral diabetes drugs and potential impact on injectables?

Michael Mason: No, I don’t think that’ll have an impact. I mean, traditionally, we don’t see a new class of diabetes agents coming in and affecting a current class. Usually the competition happens within a specific class within a diabetes market.

Joe Fletcher: Thanks, Mike. Paul, next question.

Operator: The next question is from Geoff Meacham from Bank of America. Jeff, your line is live.

Geoff Meacham: Good morning, everyone. Thanks for the question. Just had one on tirzepatide supply. I know you guys have, a plant in North Carolina and another one coming online next year. But if you look beyond that, if you have demand anywhere near what’s modeled, and even outside of obesity and diabetes, obviously, supply could remain tight. So the question is, is there a threshold of treated patients like in the near term that will inform your decision on adding manufacturing capacity? And how much does the outlook for or orforglipron have on that? Thank you.

Joe Fletcher: Thanks, Geoff for the question. I’ll hand over to Dave.

David Ricks: Yeah, thanks, Geoff. Obviously a hot topic. We work on this multiple hours every day. You’re citing the announcements we’ve made and as mentioned great progress is showing manufacturing agenda RTP sort of on track to deliver on its goal. But as we exit the year, and then that kind of in market volume following that Concord, which is a few hours away, and kind of a replica site also, well on track for coming online in ’24. So that’s good news in the ERMA [ph] presentation, which is — what we call our auto injector, from trulicity, and the current presentation from Mounjaro in the U.S. We’ve announced previously that we’re introducing now single use vial presentation ex-U.S., so that we aren’t basically sitting on approvals and connect patients have access to the medication.

That will follow them by a multi use injector that uses different property, plant and equipment than what we’re talking about here. So a couple of things to point out. You’re noting kind of new greenfield site expansions. We’ve rightfully made a big deal out of. We’re not done with those. I think you might hear more about that in the future. Of course, we are aggressively planning that and not banking on or forced upon to rescue us from this. We think that there is a need to take up parenteral incretin supply pretty dramatically from the current levels. And we plan to do that. But that will be in a combination of the current syringe-based auto injector, the vial capacity, we’ve already talked about. The multi use injector, which will come online sometime next year, and is a highly efficient play for us because it uses current systems and different ones from the auto injector.

And then there’s third party agreements that have been ongoing in the background. And to point out here, we are not relying on one. We have a diverse portfolio of third parties, recognizing that, the probability of full supply from any one is probably less than one. But buying up as much capacity as available in all those systems. So we’ve got a, I think the all hands on deck phrase was used earlier. I mean, this is really all hands on deck. And it’s a problem we work every day. So we’re not at all happy with the capacity. We’ve announced already, you’ll see more. Some we don’t announce that we’ll just layer in to the volume we ship. And of course, long term new presentations like solid oral opens up even more possibilities, but we need to do everything we can now given the huge potential for global obesity treatment for our medicines to play a key role in that, and then ultimately impact hundreds of millions of people.

So a lot of work to do here yet ahead. Thanks for the question.

Joe Fletcher: Paul, next question?

Operator: The next question is from Laura Hindley from Berenberg. Laura, your line is live.

Laura Hindley : Hi, thanks for taking my question. So I think it’s clear from your results that the next steps in Mounjaro is rapidly in progress. But how should we think about the ex-U.S. trulicity contribution going forward, which did look weak this quarter? But at the moment you’re still supply restricted? Can we expect a return to growth into next year as constraints ease or should we now assume Trulicity is ex-growth as you push the shift into Mounjaro? Thank you.

Joe Fletcher: Thanks, Laura for the question. I’ll hand over to Ilya Ufa, President of Lilly International. Ilya, do you want to address Trulicity ex-U.S. contributions in the quarter and going forward?