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

Murdo Gordon: Yes. Thanks, Vikram. Hi, Robyn. I would add, much the same way when we acquired ChemoCentryx and Tavneos, we realized that there was a low level of awareness of Tavneos. What we did there was we added reminder messaging to some of our broader rheumatology-covered sales forces to increase awareness of the data associated with Tavneos in ANCA-associated vasculitis patients. We’ve seen a corresponding increase in utilization, of course, driven by awareness of that product. So the core team is still promoting the attributes of the product and educating physicians, but there is a broader group of field personnel building general awareness of that product. What I think Vikram and I are talking about is the Amgen teams that cover endocrinologists were involved in the diagnosing and treatment of Thyroid Eye Disease, would be an ideal opportunity for us to broaden the awareness amongst that community of endocrinologists who are diagnosing and treating thyroid eye disease today to augment the great work that is happening with the rare disease teams under Vikram’s leadership.

So there’s a number of things like that where we can scale and speed up the building of awareness, for example, of the new data that Vikram was just describing and the broadening of the label language. Vikram also mentioned the international expansion. The original plan was quite ambitious for Horizon. We’ve actually increased the number of markets that we intend to file and launch in, in a shorter period of time. So that would be an additional opportunity for growth given the strength of the two companies now combined.

Robert Bradway: Might just add also, Robyn, that in terms of the time course of events here, I think now that we flip back on a year of ownership of ChemoCentryx, we can really start to see the benefit of what Murdo just described kicking in, over the last few weeks and months. So it takes a little bit of while, but I think our confidence is that over that period of time, we’ve been able to find ways that we can add distinctive value to that product and we’re hoping a similar thing will happen with respect to the new rare disease molecules that we brought on board. So it’s not like walk in, flip a light switch and suddenly things are performing on a different track, but rather you come in, work together, identify the ways in which we can be additive in the marketplace. And I’m hopeful that we’ll see during the course of ’24, the momentum build for the combined organization on these products.

Operator: Thank you, Robyn. Our next question comes from David Risinger from Leerink Partners. Please go ahead. Your line is open.

David Risinger: Yes. Thanks very much. And so my question is on oral obesity development. Regarding Phase 1 candidate 786, management has consistently emphasized that it also has a suite of oral preclinical product. And so should we take away that we should be viewing 786 as more of a wild card, rather than something that Amgen has conviction in at this point? And when do you expect to be able to start Phase 1 for another oral preclinical candidate? Might that happen in ’24 or not until ’25? And then separately, just I wanted to squeeze in a quick financial question. Do you expect Horizon product channel inventory work down in the fourth quarter to significantly constrain reported net Horizon sales in the fourth quarter? Thank you.

David Reese: Yeah. Thanks, David. Dave Reese, I’ll start and then turn things over to Murdo, and Vikram. In terms of oral obesity molecule 786, as I’ve said, it has a novel mechanism of action, it’s a Phase 1 molecule. So you should view it as a Phase 1 molecule. And we’re bringing in the data I said, and we’ll take a look at that as we get into the new year and make a determination on potential path forward for that molecule. I wouldn’t view it as anything more or less than a Phase 1 asset with a novel mechanism of action. In terms of additional molecules and when we might file INDs and launch our first in human trials, we’ll give guidance as that portfolio advances over time. Again, many of those molecules are targets that we emanated from deCODE Genetics, our colleagues in Iceland.

And I’ll provide further information as we get ready to move towards the clinic. But this is playing a long game. If you step back, look, this field is in its infancy. We are just beginning to understand the complex metabolic arrangements that occur with obesity and there are clearly different forms of obesity. There’s a lot of work to do. And as I’ve indicated, our intent here is to play the long game given that this is one of the major public health challenges of the 21st Century. So let me now hand it over to Vikram and Murdo for additional commentary on your second question.

Murdo Gordon: Yeah, David. I just want to make sure that I heard your question right, it was about inventory and product wind-down. Look, I don’t think we are going to comment on that specific aspect. I think the — our team remains focused on driving demand and working with physicians to educate them and expanding the use of Tepezza for appropriate patients and that’s where we’re really focused too as a primary driver of net sales growth.

Operator: Thank you, David. Our next question comes from Chris Raymond from Piper Sandler. Please go ahead. Your line is open.

Chris Raymond: Hey, thanks for taking the question. I just — maybe a commercial question on your dermatology strategy and specifically on Otezla, just on the dynamic that you guys talked about with free competitor drug, presumably that’s SOTYKTU scenario. And I think I heard you guys, you know, you’ve been calling this issue out for some time, but also with the investment that you’re making in the dermatology sales force, I think I heard you say today that you’re increasing that sales force sort of 20% or so. Is the implication that once the competitor free drug program runs its course, that Otezla volume should increase or what’s your sense of what happens to volume? And maybe I’ll ask it another way, if that volume increase doesn’t materialize, do you need additional derm portfolio offerings to support that added effort? Thanks.

Murdo Gordon: Thanks for the question, Chris. This is Murdo. So let’s just recapitulate what’s happening in this market. At the beginning of the year, you had a number of new launches, not just SOTYKTU, with novel topicals coming into the market as well as a novel oral and every one of those products had very generous free drug programs and that had two effects on Otezla. There were topical patients who would have normally moved to their first systemic option who tried the new topical treatments on a free drug basis. And at the same time, there was a launch of a new oral that had a very generous free drug program. And so, Otezla, which sources the majority of its growth from topical patients for systemic, in other words, biologic naive patients.

Otezla got squeezed in the first and second quarter on the basis of those new programs coming into the market. What we’ve seen since those two events in the market is that the novel topicals have flattened out in their growth and have pulled back to some extent on their free drug offering. The other oral therapy SOTYKTU continues to provide free drug, and so continues to have some effect on Otezla. What we think will happen and we’re already seeing the very early signals of this is that we will continue to source our new growth from the topical patients, bio-naive patients. Given that Otezla is the ideal for a systemic agent, we have established ourselves with really strong access in the market. So we don’t need to provide free drug programs to the extent that everybody else is.