Eli Lilly and Company — 2024 Q1

Thanks, Chris. I'll hand over to Anat to talk about the guidance raise.

Thanks for the question, Chris. And as we've mentioned earlier in the year when we issued guidance, we said that we expect capacity and supply to ramp towards the second half of the year, and that's what we're seeing.

Thanks, Mohit. You didn't say it, but I assume you're talking about Mounjaro and Zepbound so I'll hand over to Patrik to make some commentary on net price.

Thank you very much, Mohit. When you look at the pricing of Mounjaro, I think it's important to take into account that in the Q4 earnings, we announced a onetime adjustment for Mounjaro in Q4 that was quite significant. So it was a onetime adjustment in the base of Q4.

Thanks, Umer. I'll go to Patrik for that question.

Thank you very much, Umer. I think with the announcement made by the CMS early April to reimburse comorbidities for obesity based upon the SELECT trial, we're also confident that with the new data that we presented just weeks ago in terms of obstructive sleep apnea, that's going to be reimbursed in Medicare Part D. And we expect similarly for other comorbidities and the readout of HFpEF, assuming that's positive and approved, and later on with the mobility-mortality outcome study.

Dan?

Thanks, Seamus. So I'll start with the last part there. Yes, the abstract was accepted and will be presented at EASL early June. So that will be the opportunity to see the full NASH package from that Phase II trial.

Thanks, Tim. Okay. I'll maybe hand to Dan for some comments.

Yes, sure, Tim. It's probably more of your job than ours to speculate on competitor readouts but I'll take a stab at it since you asked. I think on AMG 133, we've just seen really a small amount of data. So probably anything is possible and like you will be interested to see their results. Of course, there's arguments that can be heard about GIP agonism versus antagonism. We've placed our bets, and we like the data we got with GIP agonism.

Thanks for the question, Terence. I'll hand to Patrik for commentary on IQVIA and LillyDirect.

Thanks very much, Terence. When it comes to LillyDirect, I think we are very pleased with the start. And when we look at the utilization by consumers, it's gaining traction by weeks here.

Thank you, Akash. I'll hand to Dan for a commentary on our amylin.

Yes, there are a lot of good questions in there. Thanks for following so closely. So on the GIP, the long-acting molecule, I think primarily in that experiment, we were excited to show the benefits of isolated GIP agonism, just to answer some mechanism of action questions around tirzepatide. But as you point out, there's potential for that molecule for other indications or as a monotherapy or combination with other mechanisms.

Thanks, Trung. I'll let Patrik respond.

Thanks, Trung. Now based upon what CMS stated early April, we actually expect to get obstructive sleep apnea for Zepbound covered by CMS and Medicare at the time of launch. And the next one then would be HFpEF assuming a positive readout and approval. And the third one would be the MMO indication. That's the sequence of our plans, assuming everything goes according to plan and we get the approval for both.

Thanks, Geoff, for the question. Paul -- Dave, you want to weigh in? .

Yes. Sure. And Ilya can add to this. As we think we've said on several calls now, our goal is to pursue all of the above, basically as it relates to supply options, recognizing the tremendous demand and unmet need and the constraints that exist in scaling the supply chain. So KwikPen uses existing assets, so there was less time lag. We see this first in the U.K. and now in Europe as a way to meet the needs of those patients. But we haven't ruled it out in other jurisdictions. And so we'll continue to look at every option we can to meet the needs of patients with obesity and overweight as well as with diabetes.

Thanks, Kerry. So a good multipart question, but on Lp(a), happy to talk about lepodisiran. So Dan, do you want to comment on this?

Yes. Thanks, Kerry, for the good questions here. You're right, we haven't yet published a Phase II data. But I think we just recently were able to publish the Phase I data. That was really exciting and well received. I think one of the things that people noted in our Phase I data was a very long durability of action and a very deep reduction in Lp(a) levels following a single dose of lepodisiran. We now have, of course, a Phase II data in hand and use that to design and begin the Phase III trial.

Thanks, Steve. Dan, do you want to take the question on SURPASS-CVOT?

Sure. Thanks, Steve. As you know, we do our best not to comment on interim analyses, although many of our different trials can incorporate interim analyses. But when we do talk about the risks, unintentional unblinding of results, for that reason, we prefer not to do that.

Thanks, Evan. Anne, you want to discuss [ donanemab ] and AdCom?

Yes. Thanks so much for the question. And we are incredibly confident in donanemab's potential and the fact that it offers very meaningful benefits to people with early symptomatic Alzheimer's disease and just the overall approvability of the package. We do look forward to seeing there's questions. We haven't received those yet. I think that what we'll anticipate really is discussions around the safety and efficacy of donanemab. And those -- the safety and efficacy profile remain very consistent with what we published and presented. So nothing new there.

Thanks, Dave. I'll hand over to our Dave Ricks here.

Okay. Great. Dave, great to hear from you. I mean, first of all, it is true that orforglipron is a complicated large small molecule, a large small molecule, if you were, and there are many steps in the process. You can read about them in our patent filings, I think.

Dan, do you want to comment on earlier phase obesity?

Yes. Thanks, Louise. We're excited about that portfolio of earlier-stage obesity molecules. I think there's a number of opportunities for improvement over even an excellent drug like tirzepatide. We think about the quality of weight loss as one aspect. So for example, even on tirzepatide, we see the ratio of lean to fat mass approved as patients lose weight on these drugs. Could we make it improve even faster with the muscle stimulating agents like bimagrumab? But maybe that's under investigation.

Thanks, Chris. Paul, next question?

Oh, yes, there you are. Go ahead, Chris.

Thanks, Chris. Anat?

Yes. Let me start on this. So I would say that, as I said in my prepared remarks, we expect that the supply and demand situation will remain quite tight in the near term as well as the midterm. And just to clarify, it's not that we have a production issue. Our manufacturing facilities are progressing incredibly well, and I'm incredibly proud of the work done by our M&Q colleagues around the world. Clearly, we have sites working 24/7. We're doing construction overnight. We're making the right investments and so we're progressing rapidly as you've seen evidenced by the results as well as the raise we did for the year.

Thanks, Carter, for the question. Dan, you want to comment on bimagrumab?

Yes. Thanks, Carter. It's a good question. Bimagrumab is a very different mechanism of weight loss versus incretins but one that we think could be important in combination with incretins. So bimagrumab, we think will likely have important effects on adipose tissue as well as muscle mass. And so our hope is to see increased muscle mass and increased ratio, I should say, of lean to fat mass by combining bimagrumab with incretins.

Thanks, Kripa, for the question. Jake, calling you to maybe opine a little bit on our radioligand efforts, PNT2001 in particular?

Yes, happy to. Thanks for the question. We're really excited about bringing radiopharmaceuticals into the portfolio by way of the acquisition of POINT Biopharma, and we are supplementing that acquisition with additional work through our discovery labs and the ability to make these medicines ourselves. So I expect we'll have more to talk about in terms of additional medicines over the course of the next couple of years in addition to PNT2001.

Paul, I think we've got time for maybe one more question. We're right at 11. So maybe a final question in the queue.

Okay. James, maybe I'll give to Anat to talk about the guidance and how the guidance raise relates to the 1.5x dose comments.

So let's start with the 1.5 dose -- sellable dose comment that I made on the guidance call in February. So that reference is not a number of devices, but number of sellable doses. And as we ramp up capacity for KwikPen, recall that unlike the single-use vial or the auto-injector, that KwikPen is a multidose device that has multiple doses available for patients.

Thanks, Anat. Great. Well, thanks for your time today, everyone, and we appreciate you participating in today's earnings call and your interest in our company. Please follow up with the IR team if you have any additional questions that we didn't address today, and have a great day. Thanks.