We have four members of management. By the way, I don't have a mic, so I'm just gonna talk loudly. Hopefully you can all hear the questions. We have four members of management here with us. Rob Michael, who is Vice Chairman and President. Scott Reents, who is Executive Vice President and Chief Financial Officer. Jeff Stewart, who's Executive Vice President and Chief Commercial Officer. Roopal Thakkar, who is Senior Vice President of Development and Regulatory Affairs, as well as Chief Medical Officer. Lots going on at AbbVie these days, so let's jump right in. In no particular order, let's start out with the kind of the future-looking type of question. What new indications and pipeline programs could generate phase III go/no-go decisions this year that we, as investors, can look forward to as milestones? Well, it's Roopal, so I'll start. Hang on. Are you guys hearing me okay? Okay, sorry about that. Oh, here we go. You know, I'll start out with RINVOQ just to say that, you know, we've covered rheumatology. IBD should be complete disease by the mid-year as we start seeing approvals there. Then there's another wave that we're looking at starting this year, and that is in the phase III setting. Alopecia areata, hidradenitis suppurativa, and lupus. Those are three other ones that will come, and then we'll get a phase II readout in the vitiligo space around the middle of this year and potentially move that into phase III. That's in immunology. Also, a readout for SKYRIZI in ulcerative colitis will also occur this year. In the oncology space, we have a c-Met targeting antibody called Teliso-V, which can cover up to 25% of non-small cell lung cancer in the wild type EGFR space. We'll get a readout of that through the end of this year for a potential for an accelerated approval, and we have an ongoing phase III for that setting. In the mutant EGFR space, we'll initiate a phase III program here for those who progress on Tagrisso in combination. In that setting, we see roughly 50% of those patients have overexpressed c-Met. That's quite a bit happening in immunology and oncology in that later stage setting. One thing that investors may not appreciate is those RINVOQ indications can add a couple billion dollars in the second half of this decade. Those are ones that, you know, aren't necessarily captured in our 2025 guidance, and we've talked about the potential for RINVOQ and SKYRIZI to exceed HUMIRA peak, but those indications will certainly help, and they could be sizable. By the way, I should have mentioned this at the outset. Should you have questions anywhere along the line, raise your hand and we'll call upon you. We saw the step up in R&D just recently. Is that to facilitate the initiation of phase III trials, or is that more early stage R&D oriented? Obviously a lot's going on in your pipeline. There's a lot to support. What would be the focus of that? Well, usually when you see fluctuations in the R&D budget, it's more late stage, and certainly that's the case this year. I mean, epcoritamab would be... If you think about the key drivers, I think roughly evenly split between epcoritamab, the RINVOQ pro programs that Roopal mentioned, as well as midstage programs like GARP and PTK7. it's, you know, it's not so much the early stage is usually a fairly consistent investment. It's the late stage, in certain years you'll see that rise depending on where we progress to. Okay. let's pose a few questions on HUMIRA. you've given some guidance relative to your expectation in 2023. It happened to have been at the lower end, meaning least worst end of your initial kind of thought process on the outlook. What were the factors that led to that kind of upside as we might say? You think about the 35%-55%, that was really based on a Europe experience. We saw erosion of 45% in that first year. You have markets, tender markets like the Nordics, where you have non-medical switching. I'd say there's more of a volume component to what we saw in Europe. If you look at where we are now with the 37% and where we are in terms of parity access, for lives, I mean, greater than 90% parity access. There's less of a volume component in the U.S. in year one than we would have seen in Europe, that's the big difference between the 37% and that 45, or, you know, ±10%. Okay. Is it known what the biosimilars can supply in the marketplace now? Are those known facts, or is that still an uncertainty? That's a good question. I mean, when we talk to the payers, I think in general, we see that the major suppliers have had a very good understanding of what they can supply. We've seen that internationally, they've been able to scale. We haven't seen, at least with four or five big biosimilar companies that are also coming to the United States, that there's been supply constraints. I would say, though, that it is absolutely a consideration of the big U.S. payers. For example, Steve, I believe that that's one of the reasons why you see some of the comments of, they say, up to maybe three biosimilars. They're trying to sort of balance how close those biosimilars may look to HUMIRA in terms of the overall offerings, the citrate free, the high concentration, the pen, the presentations, and also continuity of supply. One of the manufacturers did run into a manufacturing issue, and I can tell you that the heads of many of the payers sort of, you know, raised up in terms of making sure that was a big consideration. Overall, we think that the combination of these players can supply the market as the market develops. But it's a, it's certainly an important consideration for the payer's risk assessment. That is also a factor that gave you some confidence to come in at the lower end of the erosion curve, I guess. Because now you have kind of more certainty as to what those biosimilars can supply. Is that? I wouldn't say that. Yeah. T hat was something where we had profound visibility to exactly that dynamic. I would say that the reason was really where Rob highlighted, which is we were able to, you know, secure volume based on conceding price, and basically really the timing of when they would come in was really the largest determinant versus, let's say, supply consideration. We have good visibility, and we obviously know what our rebates are. We know the gating of those rebates, and we've said that as you think about the, you know, first half/second half dynamic, you'll see greater erosion in the second half because, one, in some cases, we have rebates stepping up. We also have seven to nine biosimilars coming in in the middle of the year, we expect a little bit more of a volume impact in the second half of the year. Those are things that really influenced the way we thought through the guidance, less so the considerations of biosimilar supply. Okay. Let's stick with HUMIRA but look out a little bit more. I think it's generally the perception that there will be a pretty durable tail, correct me if I'm wrong, to HUMIRA as we go beyond the next couple of years. What do you perceive to be the magnitude of that tail, and what facts lead you to that conclusion? We haven't really guided to that tail, and I can say it's something that Rob and I and the team, we're studying carefully. We're looking at the different analogs. We certainly see as we look in the European markets that there actually is a switchback component. We see actually, for example, in the U.K., 11% of patients ultimately switch back to HUMIRA. When we look across the waves in the international markets, we're still retaining roughly, you know, 40% or so of the tail. Having said that, the competitive intensity in the U.S. market is quite different. You really never got over about four players in the international markets. You know, you may have up to 10 in the U.S. market. It's something that we're watching very carefully and studying, and ultimately, as we get, you know, a more firm understanding, we certainly will highlight what we think that tail would be. We certainly think that it'll start to appear more in the 2025, 2026 timeframe. That's when that tail's gonna basically declare itself, because we see obviously the initial hit we've guided to in 2023, and then the carryover effect through 2024. We've said many times there's no perfect analog for the U.S., but if you just look at the wave one markets in Europe and where we are now versus where we were pre-LOE for HUMIRA, the revenue base is about 33, about one-third of what it was pre-LOE. Just give you a sense. Obviously, the dynamics will be different in the U.S., and when we're ready to provide more guidance on the tail, we will. I think in terms of timing, it is a good way to think about it, you know, 2025, 2026 timeframe is when you start to see that stabilize. This concept of patients switching back is a really interesting one. What's driving that? Is that inability of them to get drug that is not brand HUMIRA, or is it because of some lack of tolerability on the part of the patients? What's driving that switch back? When we've studied this a little bit, and it's a little bit all of the above. There is, you know, there's some anxiety over the idea that you've been stable on a brand and you're switching. Okay? The other thing that we've seen, I, and I think, Steve, it's been primarily more concentrated in the gastroenterology space, for example, where you may get a, an adverse event that that physician didn't like, and then you go back, if HUMIRA is available, and typically it is in all the European markets. Loss of efficacy, in some cases an adverse event. Look, overall, personally, I think those are random, you know, inter-patient or individual patient experiences. You do see this dynamic, which I think is quite different versus, let's say, a small molecule, market that develops over time. Let's move on to another important franchise of AbbVie, and that's the aesthetics franchise. It's been roughly a month since you recorded, and I think at that point, correct me if I'm wrong, you were saying that you felt the aesthetics market might gain some traction as the year goes on and maybe be more kind of more normal acting in the second half of the year. A month later, a month in now, is that thought process still holding, or is there any change to that? What we've said for the guidance for 2023 is we've assumed really no recovery in the U.S., in 2023, and I think that's appropriately prudent given, you know, we're not sure as we look at inflation, is there a risk of a recession? That said, we have seen stability in the U.S. market, and, you know, we look at, I'd say, the economic indicators that are probably most correlated with aesthetics would be consumer confidence, real personal consumption, so we're keeping a close eye on that. Google searches are a good leading indicator as well, and we're seeing a nice uptick there. You know, certainly a reason to be optimistic, but it's way too early to be, you know, calling the year, especially if you think about what happened last year. We had very robust growth in the first quarter. Then we saw a pretty rapid slowdown in the May timeframe. So the way to think about it is, you know, we'll year-over-year we'll, you know, decline because we haven't quite lapped the event up until the May timeframe and then more stability. In China, what we've said is the COVID impact, we'd see that basically, you know, we'd start to see a recovery over the first half and then probably by the middle of the year, you know, be fully recovered in China. I will say the early returns, we spearheaded about a 40%-50% market recovery index in December and January. We've seen most recently a nice bounce back, so certainly the trends are positive, but certainly too early to call in terms of what the year looks like. Okay. Questions in the audience? Okay, let's move on to another important AbbVie franchise, and that's IMBRUVICA. Why does AbbVie expect the majority of IMBRUVICA erosion to occur this year with less pressure in 2024 and beyond? What's the dynamic that's driving that expectation? We look at the basically competitive entrants. As we've highlighted in our discussions previously, we can see that, you know, AstraZeneca's product, follow on BTK, took significant share. IMBRUVICA also lost share to our own VENCLEXTA in the CLL market. Really, you have the big third player come in with Brukinsa. Brukinsa has a good profile. It was just approved at the beginning of the year, really launched at the beginning of the year. When we do our market analytics, we feel that we are gonna have some more share pressure. It's not all gonna come to IMBRUVICA, that's the big reason why we've highlighted what we, what we think in our, in our sales guidance, is the pressure from IMBRUVICA Brukinsa incremental, as well as a market that's not fully recovered from COVID. That gives you some sense. Now, once we see the Brukinsa market share penetration play out, we're gonna see some more stability going forward in 2024 and 2025. What we've said is the overall oncology franchise will be stable. You're gonna see some level of... You know, it's not necessarily saying IMBRUVICA is gonna be flat. It may still decline slightly, but you'll see VENCLEXTA offset it over the next few years. VENCLEXTA is growing, so we would see that trade-off until the pipeline kicks in, and we'd see a return to growth in 2026. For both, RINVOQ and SKYRIZI, what will be the top two growth drivers this year and next? Basically we're happy with the momentum across the board. I think one of the, one of the data points that we start to see emerging, and we highlighted this with the new guidance, or Rob did, was the inflammatory bowel disease split. The space is very, very dynamic, and we are seeing significant ramps with both SKYRIZI and Crohn's and also RINVOQ and ulcerative colitis. The adoption rates are very, very fast on both of those. That's because the performance of both of those brands in their respective approved indications is really remarkable. Very high levels of remission, especially endoscopic remission. It's, it's healing the bowel at a much higher rate than we've seen in the historical first generation of products. I think that's still underappreciated. Again, all of the indications are growing. With RINVOQ, we are clearly becoming the second line agent across most of the major indications, because of the way that the indication works in the U.S. after TNF. I think IBD is a very compelling story. It's also important to note, I think Roopal highlighted it, that we are gonna start to see the global approvals for RINVOQ and Crohn's, that come in the middle of the year to start to fill out that IBD space. That gives some flavor of how we're thinking about those two very important agents. I mean, if you look at it from a growth rate perspective, clearly IBD is gonna be the highest growth rate, but all the indications are growing in terms of actually the revenue contribution. You're seeing it really across all the indications. Okay, Rob. Quick question. Yes. On all the indications you have for RINVOQ, you said multi-billion dollars, how confident are you that the IRA won't have any impact whatsoever on RINVOQ revenue? If IRA was, if RINVOQ was selected, right, the first year would be 2028, right? You look at the Medicare mix of the business, obviously in Rheum it's a little bit higher, but as you look at all the indications, you know, if you think about the age split between different indications, you're looking at in the U.S. probably by that timeframe of Medicare mix of probably around 10%. That, you know, certainly that part could be impacted in 2028, but you've got the other 90% and a lot of growth happening from the new indications. We've, you know, analyzed that. Obviously, we've given guidance through 2027 for the combined RINVOQ, SKYRIZI. We haven't really talked about 28, but I would say there's gonna be robust growth for RINVOQ even during the IRA years. Let's move to migraine, this is an important franchise for AbbVie. Actually, Pfizer participated in a dinner last night, and it was pointed out to them that their peak guidance for their migraine franchise is $6 billion, and AbbVie's is $2 billion. Yet they would appear to be kind of on equal footing relative to their capabilities. The question arose, why isn't AbbVie more optimistic, or why is Pfizer so optimistic? Maybe you can put some color on that. I'll start. Yeah. Jeff can expand. I think to make it apples to apples, you know, you have to also consider the chronic migraine business that we have in BOTOX Therapeutic. You know, think of that as, you know, roughly $2 billion, and then you've got greater than $1 billion. It's not $1 billion. We said greater than $1 billion peak for UBRELVY and QULIPTA. When you add that all together, you'd say, you know, greater than $4 billion, Jeff, why don't you expand on the franchise? Yeah, I think it's a, it's a great franchise where you have three, you know, we said greater than $1 billion, plus we throw in our BOTOX, where we're gonna continue to expand in episodic. If you add all of it together, it gets pretty close. I mean, I think the big catalyst that we see moving forward, certainly this year, you know, our product QULIPTA for preventative migraine, we will be the only oral CGRP that will have chronic migraine. That'll be an important signal to the market, and certainly that's a linchpin for us to actually expand internationally, not just ultimately in Japan and Asia, but also in Europe. That's a, that's a big piece of our story moving forward. You're right. If you look at the performance, I mean, since Pfizer has acquired Biohaven, basically we're largely splitting the market. I mean, if I look at the actual data, we probably have about 55% of the new prescriptions when you add everything up, and that doesn't include BOTOX. We're competing very well, and I think the key message here is that there's so much unmet need that the big story, I think, over the next, you know, half decade or more is going to be the market growth with both firms in this market around the world basically sort of enhancing the growth of those oral CGRPs. There's plenty of space for both, for both companies to compete effectively and also expand the access to the drugs. I think, that competitor's been in the market maybe about four or five months now. What changes has the market incurred by virtue of them being more involved? Well, we do see that, from a competitive standpoint, that they have put more share of voice against Nurtec. Now, that hasn't translated into any improved performance at this point, but they clearly are moving to other types of primary care segments, that's something that we monitor and watch. Those are right now less productive segments. We certainly, as we look at how this marketplace will develop over time, we sort of monitor where would the next $1 might be spent. Is it concentrated in the headache specialist to gain share? Could you expand into certain emerging segments? That's something that we monitor. I think the key point is what I highlighted before. It's a, it's a nice market to compete in, and it really is gonna be two large players that will, that will shape this over time. Okay. Questions in the audience? One question on VRAYLAR. We're pretty excited about the MDD indication and think it could be big. That's what our physician experts think. It's been approved, right? Where do we stand in the rollout, and when are we gonna start seeing the results of this indication being in the label? Yeah. Thank you. We are very encouraged with the early results. I mean, we essentially started full promotion, you know, in early January, and we are seeing a very nice... and we predicted it because there was no access constraints, for example, for VRAYLAR for this particular indication. We've seen a significant uplift in our new prescriptions. Over time, those will start to flow through to the TRX. It's absolutely on track, and I would say it's a little bit above our expectations, which were quite high. Again, why is that? Number one, you have a big physician base that knows that drug and likes that drug with the core bipolar disease, and then this is a significant new indication. It's something they know, and they like it. The label also turned out very well. You had a very simple starting dose, which is the 1.5 mg, which is the same starting dose that you have for bipolar. It's easy for the physicians to start patients. We were very happy that the FDA also approved the drug for patients that are suffering from depression with or without anxiety. That also sends a very good signal in terms of the overall efficacy. We're very pleased with the first month or so of results, and we have a couple other big things that we're gonna see. We're gonna start a major direct-to-consumer program to continue to educate patients that if they're not getting the relief of their primary antidepressant, you can safely and effectively add VRAYLAR. That'll start in the April timeframe. We have, over the last years, getting ready for this, we have a dedicated sales force that calls on psychiatrists and primary care that we expanded slightly in anticipation of this launch. We think we have the right investment mix, and we're very pleased with the first weeks of the prescription data. We saw VRAYLAR pick up a half a share point last year in a highly genericized market. In our guidance for this year, we've assumed those base indications would pick up half a share point. We've also assumed another half a share point. Think, you know, one share point gain this year and for VRAYLAR, but half of it is the new indication, half of it is the base indications. We also updated the long-term guidance from approaching $4 billion at peak to approaching $5 billion at peak because of the MDD approval. Great. Let's spend the next few minutes talking about the pipeline. You have a follow on BCL-2 inhibitor in development, ABBV-453. How is this different than VENCLEXTA, and is Roche involved in this asset in any way? This is 453. This is a wholly owned, AbbVie, asset. We see much greater potency, with the new one relative to VENCLEXTA and easier amount to load drug into the tablet. Potentially a little bit better bioavailability and allows a decreased pill size, so a greater potency, maybe different, ability to drive, efficacy with this one. If you look at CLL, we'll take a look at, maybe a more convenient ramp-up, versus VENCLEXTA, and then still opportunities, in, say, multiple myeloma, expansion. Another exciting asset you have in development is epcoritamab. Where do you expect this drug will be used in DLBCL? What setting and in what types of combinations? I'll start, then maybe Jeff can move on. This is our dual engager, CD20, CD3, and what we're looking at now is an accelerated approval strategy that'll come by mid-year, and we're globalizing that as quickly as we can with the submissions. We see very strong data in a CAR T naive setting where you see ORR rates at 70%, CR rates in 42% or so. Even post-CAR T, which around 40% of the patients were, we're seeing 50%-plus ORR and 34-35%, CR rates in that population. The same goes for double-hit and triple-hit, which are very difficult to treat. We're seeing the same type of efficacy. We see it pre and post as an opportunity in third line plus. Where we would wanna move that, obviously, is in the second and front line, which those phase threes are gearing up now and likely initiate next year. Combinations that we're looking at, are R-CHOP and R² across, large B-cell lymphoma and, follicular lymphoma as well. We've done a lot of research with hematologists around the world, and it's very interesting because you have, as Roopal highlighted, this extremely positive effect in a post-CAR T environment. However, that's not where the hematologists believe it will position. It's almost like it would democratize this dual engager and be used ahead of a pretty burdensome CAR T that's very still limited in terms of access around the world and even in the U.S. The belief is that these are gonna be, you know, very widespread agents as the indications expand or the lines of therapy expand, and will be used ultimately ahead of the CAR Ts based on their potency and convenience. Epcoritamab is a, you know, fairly simple sub-Q injection, and so you can rapidly start to treat these patients in the various lines. It's a very nice profile. We're super pleased and happy with epcoritamab's development. Low single-digit CRS Grade 3 or above to add to what Jeff is saying around tolerability. Maybe we could chat about a product in the pipeline which is a fascinating concept, but I must admit I'm not exactly clear on where it stands within AbbVie, and that's ABBV-154. It didn't quite work out in RA, but you're continuing to explore it in other indications. What's the appeal of the other indications relative to this asset? Sure. This is a anti-TNF with a steroid ADC. In rheumatology, we saw high levels of efficacy, but didn't see it really differentiating from RINVOQ. At the highest doses, started to see cortisol suppression, so maybe start seeing some of that steroid effect. The purpose here would be a lower amount of steroid that's targeted the TNF expressing cells. At lower doses, we don't see that, but then in something like RA, the efficacy starts to drop, let's say, below RINVOQ. We're still studying in polymyalgia rheumatica, where patients are all on steroids already. We're also looking at Crohn's disease, which many patients that are refractory will still be on corticosteroids. There we would be looking at other doses and see if we don't see steroid-related effects. We don't see systemic effects, even in RA. We just saw, you know, the biomarker tickle. What do I mean by systemic? Systolic blood pressure, diastolic blood pressure, hemoglobin A1c, fasting blood sugar, weight, no changes, in six months of therapy. The hypothesis there seems to be playing out, where if you deliver the steroid in a targeted way, you don't really have the systemic effects. Great. We have two more minutes. We'll try to get two more questions in. You have a BCMA bispecific in development. How is it different than the competition? That's ABBV-383. What's unique about this is the way it was developed. It certainly binds BCMA with high affinity in a bivalent way, and on the other side of the asset, binds to CD3, but that's a univalent binding and also low affinity. The point here is getting to the malignant cells and sort of gently bringing in CD3 to drive down adverse events and CRS. We're seeing 60%-70% ORR in early data, fourth line plus in multiple myeloma, and similar to epcoritamab, low single digits of CR, CRS Grade 3 and beyond. That's how it was designed, and then we have some opportunities there across multiple myeloma. Teams even looking at a combination with the ABBV-453 asset that you brought up before. We have that opportunity with multiple assets that we could combine internally. Final question. You probably have a pretty good idea of what investors view AbbVie likely to be in, say, eight to 10 years. What do you think will be the biggest surprise to investors that you think AbbVie will deliver but we don't quite get? Will it be the breadth of the pipeline? Will it be the magnitude of SKYRIZI and RINVOQ? Will it be the HUMIRA tail? Will it be the sheer size of the aesthetics business or maybe something completely other than that? When we look at... We've obviously talked about high single-digit growth for this business, you know, 2024 through 2029. Clearly, when we look at sell-side consensus, isn't quite there. I do think there's an element of, I think SKYRIZI and RINVOQ can be bigger than investors expect. I mean, we've talked about some potential new indications for RINVOQ that probably isn't on investors' radar. I would point to that. I think certainly we're excited about what's in the pipeline. There's probably not a lot of value being ascribed to the potential, particularly in oncology, on some of these programs. I'd say that would, you know, potentially be another area. aesthetics, we still believe we're gonna exceed $9 billion in 2029. Sell-side doesn't believe that. I'd say probably almost, like, $1 billion below us. VRAYLAR, we've said approaching $5 billion. Sell side's probably around $4 billion or $3 billion, so that certainly can surprise the upside. Then you look at this business, you know, post 2023, our LOE exposure is by far the lowest in the industry. It's something like 1% of 2021 sales. We have a lot more financial flexibility now that we've paid down the debt very rapidly. I think when you look at the company, the setup with the growth drivers, the low LOE exposure, the flexibility, I think all those things can surprise the upside. Great. Sounds like a terrific future. We appreciate you telling us about it. With that, we'll conclude. Great. Thanks. Thanks. Thank you.