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

And then as the contracting cycle for 2024 matures and we see what the actual access is for some of the other competitors in the market, including the new oral, we should be able to give better guidance on our growth prospects for the future. But we almost certainly expect the impact of the free goods program to continue to reduce and that will help us grow Otezla. The investments we’ve made are really just kicking in this quarter. So the expansion in the field force, and your number was right, by 20%, the derm team was just deployed at the beginning of Q4. So they are only in-field as of a few weeks. So that impact is not in the historical performance of the brand. And our direct-to-consumer spend has been increased for the fourth quarter as well.

So we will be able to tell you more as we go forward, but we feel given the very large number of patients here who continue to persist on topicals, when they really are better candidates for a systemic agent, will convert to Otezla as we build into that market. And just a reminder, we’re the only product in the market that has a broad label regardless of severity of psoriasis. So we’re optimistic and we’re enthusiastic and that’s why we’ve made these investments and we’ll continue to look to add to our dermatology portfolio as we go forward.

Operator: [Technical Difficulty] Chris. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Mohit Bansal: Hey. Thank you very much for taking my question and thank you for changing the time to make sure people can enjoy Halloween. So maybe one question on sequential growth. If I look at second quarter from third quarter, it seems like pretty much every product, even including Nplate accounts for the government budget, seems to be down. I know that you warned about this in the second quarter call regarding Medicare donut hole, but can you talk a little bit about the dynamics there and how should we be thinking about this going forward?

Robert Bradway: Yeah, Mohit. I don’t think every product is down. I think we had a number of products posting pretty significant double-digit growth in the quarter. And those are products that we continue to expect long-term growth from products like Repatha, EVENITY, Prolia, our hemo portfolio, BLINCYTO in particular. So, we’re seeing some strength in our priority growth brands that we expect to continue to drive. What we did have in the quarter were a number of adjustments from prior period on net sales. So there was one particular adjustment on LUMAKRAS, which was based on a year-over-year change in the negotiations that we have on reimbursement. So in France, for example, we have an early temporary access program, and ATU program.

Since 2021 LUMAKRAS has been available in France and we took a $22 million accrual in the quarter for those sales on the basis of price negotiations we are having in France. So we had a number of events like that related to price in the quarter. And as you mentioned, we are entering the donut hole for some of our products. So overall, I think unit volume growth is very strong. A few price effects on select products in the portfolio and a little bit of donut hole impact.

Operator: Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead your line is open.

Gregory Renza: Great. Good morning, Bob and team and congrats on the progress, and thanks for taking my question. Bob, just circling back to the obesity market again, and as you and the team focused on really being first or — and/or best in class across markets, I’m just curious how you and the team view and anticipate how different the obesity market can look and how you see the unmet need morphing by the time a program from Amgen is ready for prime time. But would there be a need to look not just internally but externally to accelerate those efforts, especially if things are evolving so quickly? Thanks again and congrats on the progress.

Robert Bradway: Now, we’re very excited about what we see so far emerging from our early work in obesity. I think over time you’ve got the sense of this from Dave Reese. This is likely to be a heterogeneous disease, they’re probably going to be a number of different ways to have to go at it. But what encourages us right now is, what we think as an emerging differentiated profile for our approach versus the competition. And maybe, Murdo, you want to just jump in and remind Gregory about the basis of differentiation that we see so far in our data from the competition and why we think that gives us a good foothold for entering the markets.

Murdo Gordon: Yeah. Thanks, Bob. I like the way the question was framed. It sometimes gets framed as, what are you going to do when the — with these entrenched products in the market. And I’d just like [Technical Difficulty] people how young this market is and how much more is left to unfold. What we’re seeing in the early days is, we’re seeing a lot of patients trying these products, losing weight, but then not persisting with their treatment and regaining weight. So we think that there is an opportunity in the market long term for a product that can bring about very strong weight loss, both rapid and sustained over time with convenient dosing. And I think that that’s where 133 or maridebart cafraglutide really has an opportunity to differentiate itself from what is available in the market today.

We’ve seen the durability of that product between doses, and we think based on the Phase 2 in a number of different dosing cohorts we have being explored in that trial, we will be able to find the right balance of efficacy and the ability, based on convenient dosing to sustain that weight-loss over time. And, of course, the goal here is not just to lose weight, but to improve a number of sequelae or outcomes from people who carry extra weight over the course of their life, and that’s what we’re starting to see with others reading out in event trials. We will see more data as the medical congress has passed these next few months. But our hope is to bring about real improvement in outcomes with a highly efficacious and highly convenient product, like 133.

Operator: Thank you, Gregory. Our next question comes from Geoff Meacham from Bank of America. Please go ahead. Your line is open.

Geoff Meacham: Good morning, guys. Thanks so much for the question. Murdo, it’s been a long time coming for Repatha in submission. Are you guys finally hitting a commercial tipping point with payers, or do you think there is an increasing interest among cardiologists? I guess, I wasn’t sure how, you know, the current market is and looking forward, how about the impact? How do you guys see it from a couple of the ongoing Phase 3s and 4s? Thank you.

Murdo Gordon: Thanks for the question, Geoff. Yes, it’s been a bit of a journey. And the COVID pandemic didn’t help us in our efforts to educate and convince cardiologists that they needed to do more to be more aggressive in treating their patients; LDL, cholesterol. I do think we’ve reached a tipping point in cardiology and I do think we’ve reached a tipping point with payers. We now have over 90% commercial lives covered. We anticipate being able to continue to progress our Medicare Part-D coverage, and we’re seeing, you know, the PCSK9 category driven primarily by our 80% share of that category. Really, really starting to move now. Our new patient volume growth is good, not just in the US, but around the world. We are now seeing more and more primary care physicians using PCSK9s in combination with other drugs to more aggressively lower LDL in high-risk ASCVD patients.