Amgen Inc. (NASDAQ:AMGN) Q3 2023 Earnings Call Transcript

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So the phases are pretty clear, payer coverage established, affordability for patients established, cardiologists are now prescribing with frequency and now moving into primary care. And we’ll be adding direct-to-consumer campaign investment to that mix. So, yeah, I think we’ve reached a tipping point on Repatha Geoff and I’m bullish on what we can do to further expand that product, both from a volume and net sales perspective.

Operator: Thank you, Geoff. Our next question comes from Chris Schott from JPMorgan. Please go ahead. Your line is open.

Chris Schott: Great. Thanks so much for the question. Just a question on longer-term margins. So I guess post Horizon and I guess with the ramp of your pipeline, including some potentially very large obesity studies over time, I guess, just directionally, how should we be thinking about margins from here? I guess is this kind of 50% or slightly above 50% range a reasonable target for the company, or just any considerations we should keep in mind as we kind of balance, I guess, Horizon versus investment? Thank you

Robert Bradway: Well, we’re not going to give updated margin guidance on this call, Chris, but I think we’ve been pretty clear about what the trail should look like. We’re focused on remaining a leading efficient player in our industry. We’ve been able to achieve leading operating margins over time. There is nothing that we see in the Horizon business specifically that would lead us to conclude differently from that. So we expect that at a full run rate, capitalizing on our in-place infrastructure internationally and manufacturing and process development that the margins in that business would be attractive in our hands. And the reference that Peter made to R&D spend earlier, obviously, to the extent that we get into a number of Phase 3 trials in the middle years here of the decade for Lp(a) and for obesity products, that may have an effect on overall margins, but we’ll have plenty of time to talk about that in advance so that nobody is surprised if the margin starts moving around.

So again, we’ve demonstrated a pretty consistent ability to manage the cost structure of the business and that’s something that we’re determined to maintain.

Operator: Thank you, Chris. Our next question comes from Evan Seigerman from BMO. Please go ahead. Your line is open.

Evan Seigerman: Hi, guys. Thank you so much for the color on the call today. So the growth in perspective is pretty impressive. Just wondering how the mentioned $1 billion run rate compares with your expectations going into the deal. And then taking a step back, we saw on a JAMA article about the use of type 2 diabetes and then for gout. How are you seeing that in the broader gout space? Is this something we should be concerned about when it comes to KRYSTEXXA? Thank you.

Robert Bradway: Maybe we’ll take this in two-parts. First, with respect to KRYSTEXXA, I’d say KRYSTEXXA is performing very well and we believed it would. Again, we think there is a tremendously large unmet medical need here and that KRYSTEXXA with methotrexate is serving the marketplace well. So we’re looking forward to working with our colleagues on it. And overall, I’d say that the business is proceeding as we thought it would to this point. The things that we were — that we thought were important to have in hand, like the chronic indication for Tepezza, like, international datasets that were made available with the OPTIC-J trial, like the progress we’ve made in Brazil, et cetera. Those were things that we wanted to have in hand and now do.

And, again, UPLIZNA also performing very much in line as we expected it would. So we see three growth opportunities there and we see ways for the Amgen-based business to add value to what Vikram will be running now in our rare business area. And then, with respect to the question on diabetes, I’ll ask Dave, [Multiple Speakers]

David Reese: I mean, I think, the broader context here is important. These patients have severe uncontrolled gout. They are often facing amputations, for example, because of the severity of the disease. And so there are large number of these patients that are currently not being served in the market in clinical practice. And so our focus is on reaching those patients where the quality-of-life impediments are quite significant, and the effects of the drug can be quite dramatic in improving the disease course and improving that sort of quality of life. So that’s the focus right now. I wouldn’t get distracted by some of the other potential associations.

Robert Bradway: Now, operator, I think we have two more calls in the log here. So why don’t we take two more and then we’ll thank our colleagues and let them get on with the day.

Operator: Certainly. Thank you, Evan. Our next question comes from Tim Anderson from Wolfe Research. Please go ahead. Your line is open.

Tim Anderson: Thank you. On AMG 133, maybe this is a silly question, but is it at all possible that you can start Phase 3 in 2024? The main way to do this would be to do an early or interim look of sorts at the Phase 2 trial before the primary completion date. And I know you’re guiding for top-line on that in late ’24. Thank you.

David Reese: Yeah. I mean, as we go through ’24, we will give guidance on when we expect, you know, the Phase 3 program to launch. You know, as is customary in these programs, we will take an interim look. That will remain blinded, we will not release that externally, because this is a 52-week study, but that will help at least guide our thinking. Also recall that the FDA requires a certain safety database before you launch Phase 3 trials here. And so as we get into next year and start to have those conversations, we will be able to give more definitive guidance as to when you can expect the launch of the Phase 3 program and what that suite of studies might look like.

Robert Bradway: And let’s take our last question.

Operator: Thank you, Tim. Our last question will come from Colin Bristow from UBS. Please go ahead. Your line is open.

Colin Bristow: Hi. Good morning, and thanks for taking the questions. Maybe just a quick follow-up on 133. Just as we think about this from a commercial perspective, this is obviously an antibody backbone. It’s going to be an injectable. Just in light of margin that’s achievable with this, just help us think through that. Thanks.

Vikram Karnani: Well, Colin, you rightly point out that this is an antibody backbone. The properties of that, obviously, as I was alluding to earlier, could be that you can dose it much less frequently than you have to with the current therapies on the market. We also think, given the potential differentiation on efficacy and possibly tolerability, that we will be able to establish a very strong position in the market for people who need rapid, deep, and sustained weight-loss that they can manage over time, so that they can gain the benefits, the reduction in cardiovascular risk, the improvement in outcomes from that treatment. But we expect, as Dave said, to develop this product across a suite of Phase 3 experiments, and we expect to be able to take a decent share of the market, which will drive a good return on our investment in that product.

Operator: Thank you, Colin. I would now like to turn the call back over to Bob Bradway for closing remarks.

Robert Bradway: Okay. Well, let me thank all of you for joining us this morning. And we hope that the choice of doing this in the morning frees you up to go enjoy the afternoon and evening of trick-or-treating wherever you are. But we again, appreciate your support. It’s been an eventful few months at Amgen. And we’ll look forward to having an opportunity to regather with you and report on the fourth quarter when we get to the new year. Many thanks.

Operator: This concludes our 2023 Q3 earnings call. You may now disconnect.

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