Good morning, and welcome to day three of the Barclays Global Healthcare Conference. We're in the home stretch here. My name is Carter Gould. I cover U.S. Biopharma. I'm very pleased to welcome AbbVie to the stage. We have a full house here. Incoming CEO Rob Michael is here, as well as Scott, Jeff, and Roopal across finance, commercial, and development. Thank you all for joining us. Thank you for having us. Plenty to dig into here. AbbVie was one of our top picks for the year. So absolutely are excited to have you guys on stage. Yeah. Rob, to start, historically, AbbVie, I think, has been characterized as underinvesting in R&D, at least as a relative to its sales. You've talked in pretty forceful language around how that's changed more recently. Mm-hmm. I think one of the questions is that now, as you kinda move out of this, you know, Humira trough- Yeah and return to growth on the top line. Yeah ... how is that R&D line going to evolve, and sort of where should we anchor? Is the sort of the pre-Humira world the appropriate anchor for it, or is it gonna be something different? Yeah. I think the best way to think about it is, we view R&D investment the same way we view business development, is really driving investment to identify assets that will grow in the next decade, and so that's been our philosophy. This year, about half the increase is really coming from internal programs like 400, which is our next generation ADC, targeting c-Met with the Topo I warhead. 383, our BCMAx CD3 bispecific for multiple myeloma. Very exciting program there. Lutikizumab in immunology, with the lead indication HS, has potential in IBD as well, as well as the next wave of RINVOQ indications, which could collectively add several billion dollars in peak sales, which would, you'd see that come through in the next decade. We'll see a ramp towards the second half of the decade, but really, that peak will hit in the 2030s. The other half of the increase is coming from Cerevel and ImmunoGen. Now, given that we've returned to revenue growth just one year after the U.S. Humira LOE event, and we expect robust revenue growth starting next year to the end of the decade, we're in a very strong position to continue increasing our R&D investment, which we plan to do. But we should be able to do that and maintain that profile that today is around 14%. Now, there'll be some years where it could be higher, depending on the volume that's going through phase III, but I think it's a decent way to model it. We'll continue to increase our R&D investment. We have the sales growth to support that, and we feel like that's really the right way to approach the business as we think about the growth drivers in the next decade. Okay. Maybe it's helpful to think about operating margin in the context of that profile Rob mentioned for R&D. So as we think about operating margin, we've talked about it being relatively flat for 2023 and 2024. For 2024, we provided the guidance consistent with that at 46.5%. But when we return to robust sales growth in 2025, we'll see that operating margin begin to expand, and it'll expand over the next several years. So with R&D profile being relatively flat as a percentage of sales, gross margin, we've talked about, it's gonna stabilize where it is today, around 84%. So that means that operating margin expansion is really gonna come from leveraging the SG&A line, from driving efficiencies in SG&A, which I think we've done a very good job of in the past. So that's where we see that expansion coming from over the next several years. And it's worth just mentioning that operating margin profile we have, even today, before it continues to expand, is industry leading. So it's a top-tier operating margin as it is. Okay, so I want to spend some time, digging into the oncology side. You, you highlighted some of the programs. Yeah. You got ImmunoGen closed, lots going on. You touched on 383. And certainly, BCMA is top of mind here. Yeah. We've got some ADCs in the CAR-T arena kinda coming in, you know, the next 24 hours. How do you think about three eight three's ability to both take share from the CAR Ts, but also defend its you know within its class around some competitors, some of which are ahead of you? Yeah, that's right. Thanks for the question. You know, in this space, I would say with our BCMA asset, it'll be driven by the profile. And obviously, what's happening with competition and the environment will certainly start, I think, supporting that a little bit. We'll see what happens this week. But when you look at that data, you know, there'll be a question mark on the CAR-T side. But what do I mean by the profile? Well, first of all, we're seeing very high levels of efficacy based on the design, which is high affinity for BCMA and low affinity for CD3. And when I say low affinity for CD3, we're seeing that play out on the safety side of this, which means lower levels of CRS. So we're having, you know, almost single-digit grade two CRS. The rest of it is grade one, and that so far has been without a step-up dose. So for many of these patients, they want to start treating them fairly quickly, and if you have to do multiple step-up doses and keep coming into the hospital, that can be a challenge. This would be a singular dose, thus far, the data I'm describing to you, once a month, and that's another large advantage. And when you have lower CRS and you can stretch it out, you may even... What we're observing is even lower levels of neutropenia. So now you have strong efficacy, strong safety, great tolerability, and a very nice dosing regimen, and, you know, off-the-shelf compared to CAR T, so very accessible in academic centers, in the community, and especially, we have to think about globally as well. CAR-Ts are very much of a U.S. type of therapy. We are seeing some more uptake, but largely, if you think about the globe, it's been very challenging for uptake. So I think when you consider that whole profile, it's gonna, we believe it's gonna be very competitive in the space, whether it's before CAR-T, after CAR-T, comparing with CAR-T. And this safety profile I described may even allow us to access more of the frail populations, and then serves as a, I would say, best-in-class combination partner, so we're able to move up in lines of therapy relatively rapidly. That being said, we're going to kick off a phase III in third line this year and then look in the following years to going into earlier line of therapy. Maybe, Jeff, how do you think about sort of the pace in which the community will come along on this journey here? Yeah, Carter, it's a great question. I can't understate how excited the community is about this profile. I mean, the existing BCMA bispecifics are clumsy, right? Far later lines, lots of step-up dosing, hospitalization, and the profile that Roopal described is, it's perfect for the community. And you still have a very, very significant amount of myeloma that is served by the community. So, you know, the day-to-day hematologists are just incredibly excited about it. I mean, and Roopal highlighted it, but the level of intensity over. We wanna do these studies. We wanna get our hands on this once a month, no step-up dosing, very, very potent, off-the-shelf product, is really palpable. So I think it's gonna be fantastic. I mean, you know, CAR-Ts are gonna be self-limiting. I mean, until you really get into an ability to, you know, certainly in this country, you know, solve a manufacturing or go to the, you know, the in situ or whatever. So when you look at a profile like we've described with three eight three, it's gonna be very, very popular in the community. Maybe, switching gears a bit, ImmunoGen deal has recently closed. Can you talk about the integration, and specifically, the momentum that ImmunoGen had, that's continuing even now in your hands? Yeah, it's, it's early days, but we're very, very pleased with what we see with the team. So the team is being integrated. In fact, the entire sales and marketing team, and the field team is out in San Diego at the major conference right now with our AbbVie management team, and it's, it's super exciting. We're very impressed with how they've gone to their go-to-market. And, you know, when you look at how they've designed their in-field team, how they connect with medical affairs, how they thought about key account management, where they targeted, very, very sophisticated. And so it's not surprising when you look at the running rate of this ADC, they've executed very, very well. So we like the talent, we like how they've gone to the market, and it's quite impressive. And you highlighted the momentum that we see. We certainly see as we study, and we believed it when we did our diligence, and now we know that testing is not a barrier at all. Like, the awareness levels of the testing is, you know, is about 90%-95%, which is a very fast adoption in terms of how testing for it goes into the community and the experts. The second thing that we've seen is just this quarter in January, we continue to see nice recognition of the science. So we've had two upgrades in the NCCN guidelines on both platinum sensitive and platinum resistant, which is. It's positive. And I think probably most importantly, here, early second quarter, we think it's gonna be early April, we will have the definitive label update for the MIRASOL study. That MIRASOL study, as you know, was the one that is the definitive study that showed that survival benefit. So as you see these cascading positive aspects, we think the momentum is gonna continue to be quite strong as we start to build the clinical trials that you highlighted. We're, I think we're very excited about what ImmunoGen represents for AbbVie. You think about it, this gave us an early entry in the solid tumor space. We also have our own ADC programs with Teliso-V and ABBV-400. And then we look at their pipeline, their next generation, ADC targeting FRα, can expand into other solid tumor types. Certainly gives us, again, another growth driver for the next decade, as well as PVAC and blood cancers, which we obviously have a presence in hematology. So we're very pleased with the transaction and the early days of the integration. Maybe one more question on sort of the ELAHERE and broader ImmunoGen platform, and maybe the next step in that cascade. Roopal, the pivotal data is, at least ImmunoGen had been messaging they would be coming, you know, in the not-too-distant future. Are you still sort of supporting those timelines? And how should we think about that potentially driving a label expansion, accelerated approval? Yeah. So these data will be in platinum-sensitive third-line plus, and we still anticipate mid-year readout. I think they've highlighted last year, they're anticipating ORR above 40%, which that is, you know, more than double of what you would anticipate for single agent chemo down the road, especially because these patients that were enrolled are more platinum-sensitive, but had been through either one or two lines, either had an allergic reaction or the physician has determined they're no longer a platinum candidate. And then DOR will come out at that same time. So we'll look at that data set, and obviously, we'll have a conversation with the agencies. I think for sure it'll be impactful from a guideline standpoint, that people will wanna understand that. From an agency standpoint, it's a slightly different population because it is sensitive, so we'll have to take that data population and clearly articulate that to a health authority and see how they feel about it, because they may feel it should have been a head-to-head with a platinum or not. But that's a conversation we'll have, and a lot of that will be driven by the data. But the other piece of it, there is a formal confirmatory phase 3 running in platinum-sensitive that'll read out later on in the decade to make sure it will enable labeling. ... You brought it up, when you think about Teliso-V and ABBV-400, certainly driving some of the R&D expense, but when you think about key decisions you need to make this year on both programs, how would you frame that for folks? Yeah, so for Teliso-V, that's our first antibody that's c-Met targeting. That has an MMAE warhead. That one, we've shown our LUMINOSITY data, which is in lung cancer in the wild-type EGFR wild-type. Strong data, duration of response was more than 9 months, and again, overall survival was more than 14 months. That package, in the first half of the year, will get in front of the FDA and have a discussion around the potential for accelerated approval. Similar to what I described for ELAHERE here, there's already an ongoing phase III. That being said, we have our next-gen c-Met antibody, as Rob mentioned, as a topo warhead. That one might have a better therapeutic index, but we're gonna see readouts this year in gastroesophageal and in the lung as well. And then I think to your point, what are the decisions we make? I think we look at the both assets together and make some calls on do we pivot to one, do we stay with the other? The other option is do you even potentially combine the two up in earlier lines and replace chemo along with a PD-1, which we have some of. So those are some of the things that we're thinking about. The other critical element here with four hundred is the data we've seen in colorectal cancer, which is very strong in a third-line plus setting, where really honestly there, nothing really works, and it's very similar to what you see ELAHERE playing in ovarian cancer, where you have these later stages where it's just single agent chemo, maybe bevacizumab, but the ORRs are in the single-digit%, and we're in the 20% range in CRC, but that market is bigger than the ovarian market. So the decision we're gonna make this year is to go to phase III. In that subset, probably a c-Met high to drive ORR a little bit higher, capturing maybe roughly 20%-30% of that population. So that'll be a monotherapy phase III. Now, the other interesting thing we've observed is c-Met is expressed in a majority of those patients, and we're seeing deeper responses. So the other thing we're gonna plan is a combination with 400 and Bev, and then next year, potentially go into all comers in those later lines of therapy to round it all out as a combo. Then, what we're also doing is combining that with upfront chemo and essentially replacing irinotecan, where this ADC can come in, hopefully better depth of response, better tolerability, better safety in a chemo replacement in second line and in front line. So those phase IIs will be running. So there's a lot of activity there. I think that part, just if I could take one minute here, that's really underappreciated by investors. I mean, if you look at this ovarian cancer structure, the market structure, and basically the ability to bring in ADC and start to basically work across these lines of therapy, where you just basically have chemo or Avastin. And then you look at what we have, as Roopal described, with four hundred in colorectal cancer. It's the same market structure, except colorectal cancer is even bigger than ovarian. So it's quite exciting as he's described, particularly when we see that the potency in the later lines already with our four hundred. It's amazing how much we've just spent on oncology. I think I went back to our conversation last year, and I think we spent on oncology for about 30 seconds, so, pretty transformative. Maybe let's move on to neuroscience. Obviously, the Cerevel deal got announced late last year. We recently got a supplement request. I don't think that was a major surprise to most investors, certainly in line with sort of your commentary, but have regulatory interactions in any way shifted your confidence in getting the deal done? No. I mean, if you look at it, we have a very small share in schizophrenia, and it's a totally different mechanism of action, so we don't see this transaction as being anti-competitive. We're still very confident in closing the transaction. And note that we did not change our close timing. We maintained that at the mid-year because as we assessed this, we had this conversation last year quite a bit, as we look at the landscape with the FTC, we're seeing more second requests. So it's reasonable to assume that they would take more time to review the transaction. We're still holding to that, you know, middle of the year timeframe. We're having good conversations as we move forward, and we're still very confident we can close this transaction. I'm gonna push you on that one bit, and that is just... Is there any indication that the FTC is looking about this beyond sort of the narrow, kind of like market overlap analysis that we usually do and, you know, taking a broader view for whatever reason? There's always a whole host of considerations you make. I mean, if you think about it, the FTC always starts with a pretty wide, and the second request tends to be a pretty wide range of information, and you work with the FTC closely to narrow it down to what's we would consider to be a reasonable scope. There's nothing different that I've seen in this transaction versus what we've seen in the past, and so we're working productively to work through that process. And, you know, that's why we're sitting here in March, we're talking about sometime in the middle of the year close. That's a process that we're working through now with the FTC. Okay, great. Maybe you do have an approval coming up with nine five one, hopefully. Can you maybe help... You've talked about $1 billion+ potential. Can you help think about the addressable population here? On one hand, the numbers out there are very large, on the other hand, we see sort of the modest penetration of deep brain stimulation devices. How do you think about that? Yeah, we're very excited about 951, which is called VYALEV. It will be called VYALEV in the US and Japan, and PRODUODOPA in the international markets. We've launched in Japan for about six or eight months, in Germany, more recently in the European markets, and the market response is very favorable. It's exceeding our expectations, you know, obviously, early days. So the way that we think about it is we're creating a whole new market segment. ... So globally, there's about 500,000, over 500,000, advanced Parkinsonian patients. And if you think about it, the market structure is pretty simple. About 85% stay on orals, and they just rotate and rotate. They use more and more orals, and about 15% really go to, as you highlighted, deep brain stimulation, which is a surgery, or our own Duopa, which is a gastric surgery. So there's like a barrier. It's like a, a surgical barrier between the orals that are not working. And so what we've done with nine five one at subQ that works for 24 hours, it can be exquisitely titrated, and patients that have trouble frozen, they wake up on. So it's very—it's very good benefits. So what we're doing is we're creating a subQ market between those orals, Carter, and the surgeries. So a whole new market space, we believe, will open up and drive that greater than a $1 billion-dollar opportunity. It's, you know, it's no longer, you know, hope because we can see in major large business units that neurologists and Parkinson's experts, motor disorder experts are adopting quite well, so we're pleased. Great. So we have five minutes left, and we haven't touched on I and I yet, which I think is, shows the, the transformation that AbbVie's had over the past year. As we think about, Humira into 2024, we saw, you know, in, in 2023, it was sort of dominated by this first half or second half, and even to a greater extent, sort of later second half, kind of phasing dynamics. Are we going to see a similar situation here this year when you think about other payers taking, you know, different actions and different segments playing out? Yeah, I think, you know, 2024, as you said, 2023 was a partial year. You had biosimilars coming in, obviously, one in early February, several middle of the year. For 2024, it's the erosion that we guided to, $7.8 billion, around 36%, very similar to 2023, but it's driven by price again, so the vast majority of it's price. But the price has two dynamics. If you think about 2023 versus 2024, there's a pretty big price annualization effect. So the price, you know, about a third of the price driver is annualization. The remainder will be additional price, and then you will have volume. I would say that volume is going to continue throughout the year, and you'll see more volume as the year goes on. So a little bit different dynamic. The mid-year step down you saw last year was unique to the circumstances of having the 79% of the market. Yeah. We do not have that dynamic playing out. Right. Okay. I was, I should have specified, I was talking more about the pricing dynamics, but good point. Okay. Yeah. When we think about SKYRIZI and RINVOQ, Q1 has traditionally been a bit challenging for AbbVie, as it is for a number of companies. Anything you'd kind of call as we think about, you know, the very near term kind of dynamics that people clearly care about? We spent a lot of time, obviously, this year, with us get more, even more granular. Right. In the past, we were pretty granular with first quarter call with therapeutic area guidance. We now gave you specific product level guidance within immunology, given the dynamics last year. We've reiterated that, you know, this year we said, the price erosion is, low single digits, versus last year was high single digit. There was a reason why it was high single digit. We had 7 new indications. We gained very rapid access. We built significant volume growth. If you think about SKYRIZI and RINVOQ, you know, SKYRIZI, I think, growing 50%, RINVOQ growing 60%. So tremendous revenue growth despite having high single-digit volume erosion last year. This year, again, low single digit price. You would expect again, like you see every year with, especially pharmacy, destocking happening in the first quarter, that same dynamic, given that the rate of volume growth, the year-over-year comp, you have a, I'll say, high single digit impact year over year because it's a growing business. That's all factored into the guidance that we gave at a product level. And so and we're, we're seeing very robust, volume growth. So I think hopefully, we don't have a repeat of what happened last year with, you know, some mismodeling, misunderstanding of the first quarter dynamic. We saw the rest of the year played out as we had guided. We, we expect to actually beat those estimates. But this year, I think first quarter, hopefully, we've given enough clarity to the street that we don't have a repeat of last year's first quarter. Okay, so for the current approved indications for RINVOQ and SKYRIZI, I think generally, you know, people have different assumptions, but I think there's generally a good handle on it. But in terms of the next wave of RINVOQ indications, I think there's maybe an underappreciation of some of those. As you think about those commercially, or Roopal, feel free to jump in. I, you know, sort of what do you think is underappreciated by the street? Which of those is potentially more impactful? Any, any commentary there? Maybe I'll quickly comment- Please. And then Jeff. So there are several. Of all of them, the smallest is GCA. So park that for a second. The other ones are lupus, HS, vitiligo, alopecia areata. Now, for the first two, lupus and HS, those are places that physicians already know to prescribe. They're established markets. In fact, Jeff and his team established the HS market years ago with Humira. So that one, with RINVOQ, will be post-anti-TNF, so they'll be able to take advantage of these patients that are, you know, not responding as well. We've seen strong responses in a failure population, so that'll be a nice spot. And then lupus, you have a couple biologics, not always very satisfactory outcomes and can take a long time to work. RINVOQ, being a small molecule, has a very rapid onset, so that'll be a nice spot already, and people will have a non-biologic option. These are pretty large spaces. Then alopecia areata and vitiligo will be a little bit newer. However, the benefit is that RINVOQ will have been known to prescribers for many, many years and will have the largest database from a safety standpoint, more than any other competitor. Given that there are newer markets and newer spaces, we feel we'll have that really nice advantage again with the data that no one will be able to match. Roopal highlighted it very, very well. So, they're all those four that he highlighted are all reasonably balanced in terms of what we see the commercial revenue. If you were here today to bet on established markets, as he highlighted, you'd bet on lupus and HS. We think we've got a nice setup across all four. Appreciate the color. Okay, well, we're out of time, AbbVie. Best of luck this year. Thanks very much for joining us today. Thank you. Thank you, Carter.