Vikram Karnani: Yeah. Thanks for the question. I think as I said in my prepared remarks, we have a lot of positive leading indicators as we look at the business. I’ll start with Tepezza. We’re continuing to build that U.S. TED market following the FDA’s April 2023 label updates. And that really helps us get the medicine to TED patients regardless of disease activity or duration. And what we’ve seen following that label update is that the payers are continuing to update their medical policies and make them more favorable so that more of these patients, more in the low CAS setting or the low Clinical Activity Score setting can now access Tepezza. And I think, finally, from an execution standpoint, we see newer prescribers from both ophthalmologists, as well as endocrinologists increasing 50% year-over-year in this third quarter.
So all of these indicators for Tepezza are positive and we feel good about the execution of the team. And as I said, we have now combined forces with Amgen and together we should be able to drive business in a positive way moving forward. Think — talking about — the story around Tepezza also is one of international growth. While we see a lot of positive trends in the U.S., we’re pretty excited about what we can do as a combined company for patients outside the U.S. as well. We’ve talked about Brazil getting approval recently. We’ve got [indiscernible] OPTIC-J as our trial in Japan. We’ve talked about the chronic trial that’s enrolling. And finally, we’re getting ready for other markets and we hope to bring the medicines to many more markets now as part of the combined company than we were talking about previously.
So Tepezza, both signs very positive in the US as well as globally. And as we’ve talked about the results for KRYSTEXXA and UPLIZNA, both those medicines performed really, really well. We have immunomodulation with KRYSTEXXA being a major driver since the label update last year. That has continued to drive uptake since that time. We see that continuing into the future. And with UPLIZNA, it is the fastest-growing biologics in neuromyelitis optica spectrum disorders or NMOSD, and we see that momentum continue both in the U.S. as well as outside the U.S. So I think when I look at the overall portfolio we have, we’re operating from a position of strength and now we can expand that even further with the combination with Amgen.
Salveen Richter: Thank you, Vikram.
Operator: Thank you, Salveen. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.
Jay Olson: Hey, congrats on all the progress on so many fronts. Could you talk about your investments in AI technology and how that may influence your drug discovery and development over the next five to 10 years? Thank you.
Robert Bradway: Sure. I’ll ask Dave Reese to address that, Jay.
David Reese: Yeah. Thanks, Jay. This is an area where we’re very excited. You know, I’d like to characterize it as the hinge moment where we’re seeing the coming together or the unification of technology and biotechnology. I really think this is going to affect over time a qualitative change in how we do drug discovery and drug development. So everything from protein structure prediction, protein-protein interaction, prediction at the molecular level, to multiomic analysis on extraordinarily large datasets which can — which is only tractable through AI or machine learning, dense clinical trials data and then real-world evidence and real-world data. When you look across that spectrum, I believe we probably have the largest datasets in the industry.
And so we are putting the tools in place and the foundation or models to really mine those data for deeper insights in the biology and then all the way out into the market. We’ll talk about this more over time. But this is going to be an area of investment and it can be overhyped. It’s not a panacea, but it is absolutely going to be the most powerful tool we’ve seen in a long, long time.
Operator: Thank you, Jay. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.
Umer Raffat: Hi, guys. Thanks for taking my question. Dave, I have a two-part question on AMG 786, the oral for obesity. First, I noticed you guys dropped a cohort in your SAD portion of the trial. Is that because you ran into MTD? And then also, I noticed the exclusion criteria around suicide ideation were intensified and I can’t tell if we could be reading into that or not, would love to get any color. Thank you
David Reese: Yeah. Thanks. On the latter, I wouldn’t overthink that at all. I don’t think there’s anything there. In terms of the dosing that we do, this is always adjusted as we move through Phase 1 trials. As I’ve indicated, we’re bringing in the data now, we’re taking a look at that. And the constellation of clinical data — updated preclinical data, and I think we’ll have that all together as we go into next year and that will determine the potential path forward for AMG 786. And just to remind everyone, this is a target that is not an incretin-based target.
Operator: Thank you, Umar. Our next question comes from Robyn Karnauskas from Truist Securities. Please go ahead. Your line is open.
Robyn Karnauskas: All right. Thanks for taking my question. I do have a follow-up to Salveen’s question actually. So Tezspire has gotten a lot of market share, there is so much room to grow in the TED space. Can you walk me through, like how Amgen can actually help grow that business because I’m confused by whether it’s the hearing loss or reimbursement or what are really the levers that will actually grow that company — grow that business — Tepezza, sorry, Tepezza, that I think that there’s a lot of room to grow. And given your strength, you could probably make that work. So, how do you intend to do that?
Robert Bradway: Okay. Thank you, Robyn. So I think it’s a two-part question there on Tepezza. We may tackle it in two parts with the combination of Vikram and Murdo. So go ahead, Vikram, why don’t you start?
Vikram Karnani: Yeah. Thanks for the question. Like I said earlier, the — I think one of the areas that has — something that happened this year was the FDA update. Now when the label updates to patients that are treated regardless of disease activity or duration, many of these patients, in fact, I would say more of these patients are being treated by prescribers, such as endocrinologists and ophthalmologists. And that’s what the team has been focused on working through, making sure that our educational program is available to these physicians, so that we can widen our prescriber base from the original set of prescribers that started treating patients at launch. So it’s really important to understand that expanding the prescriber base is a critical driver for that success going forward.
And as we’ve seen new prescribers have increased 50% year-over-year. As we continue to work through these new — this low CAS or low clinical activity patients, we also have to remember that when they are prescribed the medicine, payers need to open up access to the medicine. So our market access team has been working pretty diligently to make sure that payers continue to update their medical policies. And what we have seen is more than 30% of U.S. covered lives are now eligible patients that can access Tepezza with more open or more favorable policies. This has to continue and both of these are areas that we will continue to work on as we go into early next year and beyond. And maybe I’ll turn it over to Murdo to add his comments as well.
