Eli Lilly and Company (NYSE:LLY) Q4 2023 Earnings Call Transcript

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Andrew Baum: Thank you. Could you talk to your scenario planning for post-2032 when the potential exists for generic somatocytes to be launched? There seems to be significant interest and investment in capacity expansion. Now, obviously, this is complex, as you outlined, given not just API, but fit and finish and IP and the rest of it. But I’m just curious how you think about that in terms of future-proofing your business against step edits and other thinking about your broader Inquity portfolio?

Joe Fletcher: Thanks, Andrew. It’s a very long-term question. I’ll pass over to Anat to talk about 2032 and beyond.

Anat Ashkenazi: We do look at 2032, and we actually do look beyond. And the way we look at our business, it is a long-term business. It’s not a business that changes every year or two. So we do look at the long-term horizon, both in terms of the commercial products as well as what’s coming through the pipeline and as we think through the events of that next freeze, whether for our products or those of competitors, our way of managing through that is to bring new breakthrough innovation to the marketplace. So to raise the bar on our own innovation, we don’t wait for that to occur or happen by competition, but to bring something into the market that provides a meaningfully improved outcome for patients. So in this specific example, you use the GLTs, Shirley True’s appetite brought in a higher bar for weight loss for patients with chronic weight management.

And [indiscernible], that Dan referenced in his comments, currently in Phase III has the potential to bring even further improved outcome for patients. So that’s how we see that. In terms of capacity and one of the questions is on whether companies should be or shouldn’t be building, given that there is a patent expiry at the end, we do look at that and we look at the long-term horizon. But certainly, the investments in a metro facility, for example, the ones we’ve just mentioned, whether it’s in Concord, North Carolina or Research Triangle Park, between the two of them, it’s about a $4 billion investment, are certainly a good investment of our capital, given that size of opportunity over the long term. I will say that as you think about potential for either generic or biosimilar entry in this space, in general, it will require quite a massive investment in capital.

Just the sites that I’ve mentioned today in the call and we’ve talked about for the past year or so total about $11 billion, and that’s on top of already substantial network we have around the globe, primarily in the U.S. and Europe for production. So as you think about entering into that space, it will require some significant capital commitments.

Joe Fletcher: Maybe a final question, Paul, and then we’ll wrap up.

Operator: The next question is from Tim Anderson from Wolfe Research. Tim, your line is live.

Timothy Anderson: So one of the competitor data, obviously, everyone is watching as the Amgen data this year. And their messaging is around longer dosing frequency, monthly dosing and then possibly a greater effect of weight loss off-therapy. So can you comment on your views of the value of extended dosing like monthly or longer? And then do you believe in that argument about efficacy being sustained off-therapy? Or is that just a function of the fact that this drug lasts longer?

Joe Fletcher: Dan?

Daniel Skovronsky: I’ll start with the second, and then maybe Patrik will weigh in on potential value here although that could be a good question for Amgen. Look, I think the sustainability data I saw in that publication are a bit underwhelming. It’s a very high-dose drug at half-life of an antibody. So just based on plasma concentrations, that would be extended to — expected to remain there after a month or two. It doesn’t surprise me, but what we’re seeing is that at doses that are reasonably well tolerated, if there were any doses that are reasonably well tolerated, weight loss is lower than what we would need to see to take a molecule to Phase III for sure. And sustainability doesn’t appear to be at all differentiated.

Patrik Jonsson: Only addition would be that when we look at the market research, of course, convenience is one factor, but it’s not necessarily the most important factor when it comes to provider and consumer selecting treatment. So I’m really excited about the we have in our hands. Of course, Tirzepatide remaining a foundational treatment for obesity, but also with the addition of orforglipron and also the opportunities here to look into options with additional non-weight loss-dependent pharmacology to complement the assets we have in the pipeline.

Joe Fletcher: Dave, do you want to wrap this up?

A – David Ricks: Yes, absolutely. That’s good, Joe. Thanks. We appreciate everyone participating today and, of course, your interest in the company. 2023 was a really productive year for Lilly, and we look forward to continued momentum in 2024 with a strong guide today. Thanks again for dialing in. And please follow up with Joe and the IR team if you have additional questions that weren’t answered. Thanks.

Operator: Thank you. Ladies and gentlemen, this does conclude our conference for today. This conference will be made available for replay beginning at one p.m. today running through February 20 at midnight. You may access the replay system at any time by dialing (800) 332-6854 and entering the access code 187676. International dialers can call (973) 528-0005. Thank you for your participation. You may now disconnect your lines.

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