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J.P. Morgan Healthcare Conference

Jan 11, 2022

Chris Schott
Managing Director, JPMorgan

Good afternoon, everybody. I'm Chris Schott at JP Morgan, and it's my pleasure to be introducing AbbVie today at the 40th Annual JP Morgan Healthcare Conference. From the company, we're gonna have a presentation from Rob Michael, the CFO, and we'll have Mike Severino, President of AbbVie, and Jeff Stewart, Chief Commercial Officer, joining us for the Q&A. Rob, Mike, Jeff, Happy New Year. Thanks for joining us, and I look forward to the presentation.

Rob Michael
CFO, AbbVie

Great. Thank you, Chris, and good afternoon, everyone. It's a pleasure to be here today. Before I begin, please take a moment to review our forward-looking statements on slide two. Turning to slide three, since AbbVie's inception, we have developed and assembled a broad portfolio of diversified growth assets with leadership positions across several attractive markets, including immunology, hematologic oncology, neuroscience, aesthetics, and eye care. Our existing commercial scale with a dozen blockbuster brands and our robust pipeline of novel late-stage therapies and promising new indications support AbbVie's long-term growth outlook. Following the U.S. HUMIRA LOE event in 2023, we expect to quickly return to growth in 2024 and deliver high single-digit growth from 2025 to the end of the decade. This is a testament to the strength of AbbVie's broad portfolio.

Turning to slide four, AbbVie represents a unique investment opportunity, well-positioned for attractive shareholder returns, including a significant opportunity for P/E multiple expansion. Our robust long-term growth outlook will generate substantial operating cash flow and will support our capital allocation priorities. This includes investment in innovative R&D across our therapeutic categories, with total R&D spend having more than doubled since our inception. Capacity for business development, with approximately $2 billion allocated annually to augment our pipeline with the most promising external technologies and innovative therapies. Continued debt repayment. We have already repaid $17 billion of combined company debt and expect to achieve a net leverage ratio of approximately 2x by the end of this year. We will continue growing the dividend, which remains a key priority and reflects an attractive yield for shareholders.

Last October, we announced an 8.5% increase in our quarterly cash dividend, which we have now grown by more than 250% since inception. This further underscores our confidence in AbbVie's long-term outlook. Now moving to slide five. AbbVie has consistently delivered top-tier financial performance. Since becoming a public company in 2013, we have delivered strong double-digit adjusted earnings growth and have nearly tripled our adjusted net revenue. As you can see on slide six, we are making excellent progress with the integration of Allergan and are tracking well against the financial commitments that we made at the time of the transaction. We are exceeding our revenue expectations in several areas across the portfolio, most notably Botox, Vraylar, Ubrelvy, and Eye Care, which are outperforming our initial projections.

We expect to deliver expense synergies of greater than $2 billion in 2022, with accretion above our original guidance. We have achieved the high end of our debt paydown range through to 2021, and will continue to pay down debt through 2023. Turning to slide seven, our long-term growth will be driven by numerous differentiated assets across each of our core areas. In immunology, we are well-positioned for sustained leadership with a portfolio of best-in-class pins and an innovative pipeline. RINVOQ and SKYRIZI already have had a large impact on AbbVie's growth, with approximately $4.6 billion of combined sales expected in 2021.

This very strong performance, along with the progress we have made across our broad development programs, which cover all of HUMIRA's major indications plus atopic dermatitis, give us a high level of confidence that RINVOQ and SKYRIZI will remain major growth drivers for the company going forward. Following the U.S. RINVOQ label update in RA, indication approval in PSA, and regulatory progress with atopic dermatitis, we are confirming our prior guidance of more than $15 billion in combined risk-adjusted global sales for RINVOQ and SKYRIZI in 2025. Of the $15 billion, we now expect $4.5 billion to come from international markets, an increase of $500 million versus our previous guidance, thanks to strong labels and the approved indications standout launch progress to date. We have updated our product level guidance as well.

We now expect global sales for SKYRIZI to reach more than $7.5 billion in 2025, an increase of $500 million versus our previous guidance, reflecting higher share performance in psoriasis. We also now expect RINVOQ to achieve more than $7.5 billion of global sales in 2025. This contemplates a lower contribution from U.S. rheumatology and dermatology, given the updates to JAK inhibitor labels, and is partially offset by higher sales for IBD based upon strong phase III data in both UC and Crohn's disease, as well as stronger international performance overall. As we look beyond 2025, we expect combined peak sales for RINVOQ and SKYRIZI to exceed the peak revenues achieved by HUMIRA. Moving to slide eight.

Despite recent advances, there continues to be a need for more effective therapies for treating chronic inflammation and immune-mediated diseases. AbbVie's early-stage immunology pipeline is aimed at developing novel agents that will advance standard of care through deeper and more durable responses. Our immunology pipeline includes several promising programs, including ABBV-154, our anti-TNF steroid ADC, which is currently in phase II development for RA, PMR, and Crohn's disease. ABBV-157, our novel small molecule RORγt inverse agonist, which is currently in a phase II dose-ranging study for psoriasis. ABBV-668, our novel small molecule RIPK1 inhibitor in phase I development, which has the potential to offer differentiated efficacy in UC and other diseases. Turning to slide nine. AbbVie has built a significant and sustainable leadership position in hematologic oncology with IMBRUVICA and VENCLEXTA. IMBRUVICA is a market-leading therapy in CLL, relapsed/refractory MCL, and other blood cancers.

As a first-in-class BTK inhibitor, the magnitude of data generated with IMBRUVICA across lines of therapy and in different combinations is unmatched, with clinical and real-world evidence across multiple different settings showing sustained disease control and, importantly, overall patient survival. VENCLEXTA is our first-in-class BCL-2 inhibitor and another foundational treatment that offers deep and durable responses for multiple hematologic malignancies. VENCLEXTA's approved indications in CLL and AML are both seeing robust share performance. We are also pursuing VENCLEXTA in other important areas, such as multiple myeloma in the t(11;14) biomarker-defined patient population, as well as high-risk MDS. Turning to slide 10. Beyond IMBRUVICA and VENCLEXTA, we have an exciting oncology pipeline with several promising programs in development for blood cancers and solid tumors.

Our mid- to late-stage oncology pipeline includes navitoclax, a novel BCL-2/BCL-XL inhibitor in phase III development for myelofibrosis, which has the potential to provide disease modification in a market where current treatments only address symptoms. Epcoritamab, a potentially best-in-class CD3 by CD20 bispecific being developed with Genmab, currently in registration-enabling studies for B cell malignancies, including DLBCL and follicular lymphoma. ABBV-383, our BCMA by CD3 bispecific, which has the potential to become a best-in-class treatment in multiple myeloma based on early data that show compelling efficacy and safety. Teliso-V, our c-Met ADC being studied for non-squamous, non-small cell lung cancer. Early data have demonstrated strong response rates in patients with overexpressed c-Met, and we believe Teliso-V can play an important role in this segment, representing approximately 25% of the overall market. Moving to slide 11.

In neuroscience, we have a portfolio of compelling therapies for migraine, psychiatric conditions, and neurodegeneration, with sales of $5.8 billion expected in 2021 and strong growth momentum. I'll start with migraine, where AbbVie is the only company to have a portfolio of multiple distinct therapies to address the full spectrum of this disease. This portfolio includes UBRELVY, our leading oral CGRP treatment for acute migraine, which provides rapid and sustained pain relief with convenient dosing. UBRELVY is annualizing at roughly $700 million and has the potential for peak sales in excess of $1 billion. We also have QULIPTA, the only oral CGRP treatment specifically developed for the prevention of episodic migraine. Early feedback from physicians has been very positive given QULIPTA's demonstrated efficacy, including a rapid and meaningful reduction in migraine days.

We have seen strong prescriptions in our first quarter on the market and expect commercial access to rapidly expand in the H1 of 2022. We are also pursuing an indication for chronic migraine prevention, which is currently in phase III development. We believe QULIPTA peak sales can exceed $1 billion as well. Rounding out the migraine portfolio is BOTOX therapeutic, a unique foundational treatment for prevention of chronic migraine. After more than a decade, BOTOX therapeutic continues to deliver strong growth and remains a branded leader in new patient starts. Turning to slide 12. We also have important products and promising R&D programs in psychiatry and neurodegeneration. VRAYLAR is one of the fastest-growing medicines in psychiatry, with sales of approximately $1.8 billion expected in 2021, increasing strong double digits.

Despite competing in a heavily genericized market, VRAYLAR is differentiated by a strong benefit risk profile relative to other atypical antipsychotics, including efficacy across multiple indications with minimal impact on weight, lipids, and fasting blood glucose. With continued share gains, we expect VRAYLAR peak sales to approach $4 billion for the currently approved indications. MDD is a potential large indication for VRAYLAR that would expand its coverage of mood disorders. We recently reported positive top-line results in one phase III trial where VRAYLAR demonstrated strong efficacy as an adjunctive treatment, which complements a prior registrational phase IIb study that was positive as well. Based on the totality of the data across our MDD program, we plan to submit our regulatory application to the FDA in the coming months. If approved, this indication would be an upside to our current projections.

In neurodegeneration, we have ABBV-951, a potentially transformative next-generation therapy for advanced Parkinson's. 951 delivers dual efficacy through a less invasive delivery system, with the potential to expand the patient population currently addressed by DUOPA and other more invasive therapies such as deep brain stimulation. We plan to submit our regulatory applications in the first half of this year and believe 951 has the potential to achieve peak sales in excess of $1 billion. We also have efforts aimed at discovering and developing disease-modifying therapies to treat Alzheimer's. We are investigating several approaches, including Aβ programs directed at antibodies that clear plaque more rapidly than existing agents with a reduced risk of ARIA, approaches for clearing intracellular tau aggregates, and programs that modulate the neuroinflammatory response. We look forward to providing updates on our neural programs as the data mature.

Moving to slide thirteen, our leading aesthetics portfolio represents a very attractive growth opportunity. This largely cash-pay portfolio is anchored by several well-known brands, including BOTOX Cosmetic, the market-leading neurotoxin, JUVÉDERM, a leading portfolio of injectable dermal fillers, and CoolSculpting for body contouring. Our increased promotional investment has driven accelerated category growth, especially in toxins and fillers, where there are substantial room for additional market penetration. We have increased DTC across major brands, enhanced digital products and services to our Allē platform, and executed field force expansion in major global markets. As a result, we have retained more existing patients and have increased the number of first-time consumers to our leading aesthetics portfolio. We are also focused on delivering new product innovation through greater internal and external investment.

Our aesthetics R&D programs include new indications for BOTOX Cosmetic and JUVÉDERM, innovative new products, including both short-acting and long-acting toxins, as well as novel fillers with biostimulatory or regenerative features and new offerings within the body contouring category. We also remain active with business development and have been pursuing complementary products and new technologies, including Luminera and Soliton. Given all this, we expect our eye aesthetics franchise to deliver high single-digit revenue growth through the end of the decade, including sales of more than $9 billion in 2029. Now moving to slide 14. Our eye care franchise includes multiple leading brands that help preserve and protect vision.

We continue to maximize the performance of our existing portfolio in glaucoma and dry eye, including RESTASIS, and we have been advancing several new products and novel therapies, including VUITY, which was recently approved as the only eye drop for the treatment of presbyopia, a common and progressive age-related eye condition that affects nearly half of the U.S. adult population. Our GX 314, which is an anti-VEGF gene therapy being developed with REGENXBIO and has the potential to be a one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. We will continue investing in eye care to build a novel pipeline that addresses significant unmet need and ultimately drives long-term growth. Turning to slide 15, AbbVie has built an innovation-driven R&D organization and one of the strongest pipelines in the industry.

We set aggressive goals across our discovery and development organizations, and we are very proud of our ability to develop medicines that elevate standards of care for patients. Since inception, we have secured 21 major product or indication approvals, more than doubled our adjusted R&D investment, and nearly tripled the number of programs in development. Now moving to slide 16. AbbVie's R&D efforts continue to demonstrate strong progress with more than 80 clinical programs across all development stages. The breadth and depth of the pipeline support our long-term growth outlook, and we anticipate numerous important pipeline milestones over the next two years. As you can see on slide 17, we anticipate the potential approval of more than a dozen new products or major indications in 2022 and 2023, which will collectively add meaningful revenue growth on the other side of the U.S. HUMIRA LOE.

This includes several additional indications for RINVOQ and SKYRIZI, expanded indications for IMBRUVICA, VENCLEXTA, VRAYLAR, and QULIPTA, and multiple new product approvals, including navitoclax, ABBV-951, and epcoritamab. Over this two-year timeframe, we also expect proof of concept data from approximately 20 early and mid-stage programs. These programs have the potential to drive additional growth for AbbVie in the middle part of the decade. In summary, on slide 18, we are executing well across our business and have assembled an impressive set of diversified assets with significant revenue potential, giving us a high degree of confidence in our long-term growth outlook. With that, I'll turn it over to Chris for Q&A.

Chris Schott
Managing Director, JPMorgan

Great. Thanks for those comments, Rob. Maybe just to kick off the Q&A, would love to dig a little bit more into the updated immunology targets. So maybe just to start the conversation, talk about the comfort. What got you comfortable providing these targets, I guess, so shortly after the label update and prior to an atopic derm approval in the U.S.?

Michael Severino
President and Vice Chairman, AbbVie

Well, Chris, you know, I think there are a number of factors to consider. One, we've seen the RA label.

Chris Schott
Managing Director, JPMorgan

Mm-hmm.

Michael Severino
President and Vice Chairman, AbbVie

We've seen how we can perform with that label, and we've also seen increased confidence both in treating physicians and in the investment community and the value proposition on the basis of that update. We've seen the psoriatic arthritis approval, which is another important approval. That is an important component of the rheum franchise. It's not as well appreciated as RA typically, but it is very important. We've seen strong data in ankylosing spondylitis in the biologic-refractory population and in non-radiographic axial SpA, and we've made good progress with our regulatory review of atopic dermatitis. Around the world, we have approval in Europe with a very strong label with both those doses approved.

We continue to make good progress with the U.S. FDA on that review, and we have continued confidence in the profile based on the clear benefit and the overall benefit risk that we have delivered. It was all of those features that led us to provide the updated guidance that we did today.

Rob Michael
CFO, AbbVie

When you look at just the final performance that we're seeing, for example, for SKYRIZI in psoriasis. We already have in the U.S. the leading TRX share position. We've now surpassed HUMIRA. We've seen very strong performance with psoriasis. We thought it was appropriate to update the guidance, given that stronger performance. When you look at RINVOQ, you know, with the dynamics of, you know, when we gave guidance early in 2021, you know, we were anticipating approval for the new indications. We were anticipating the safety communication, yet we still delivered, you know, we never took that guidance down, right?

We just have seen, I'd say, underlying performance in the business, in addition to the pipeline updates Mike just provided, that gives a lot of confidence that, you know, both RINVOQ and SKYRIZI can perform at a very high level.

Chris Schott
Managing Director, JPMorgan

Great. Just a couple follow-ups there. Maybe on atopic derm. I think there've been some expectation we might hear about this around year-end. Just can you remind us what your base case you're reflecting in this guidance, like the $1.7 billion in terms of the U.S. approval? Is it one dose versus two doses? Is it a second line label versus something broader? What's your latest thinking on where that could land?

Michael Severino
President and Vice Chairman, AbbVie

Well, we feel very comfortable with our ability to compete with either dose. We've said previously, and we still believe that the benefit-risk profile of both doses is appropriate, is favorable, and both doses, we believe, have a role in the treatment of atopic dermatitis. Both doses deliver very strong response. They deliver very deep response and very rapid response. We would view them each as having a favorable benefit-risk. You can see the approval decisions that were taken in Europe as support of that point of view. With respect to restriction in the U.S., I think based on the safety communication that the agency put out in September of last year, it's reasonable to assume that there'll be some degree of restriction to second-line therapy.

Exactly how that's worded in atopic dermatitis, we'll be in a better position to describe when the final label comes out.

Rob Michael
CFO, AbbVie

I'd say, you know, early days in the international markets, we're seeing very, very strong uptake. In fact, our guidance at 1.7 does contemplate an additional upside in international. There is a mix between U.S. and international. International doesn't fully offset the U.S., but we are seeing some very early returns that are very favorable for AD outside the U.S.

Chris Schott
Managing Director, JPMorgan

Great. Another point, Rob, maybe I missed it in the slides, but could you remind us where the mix was of that $15 billion if we thought about U.S., ex-U.S. in the prior guide and where that's moving to in the update?

Rob Michael
CFO, AbbVie

In December of 2020, when we gave the $15 billion, it was about $4 billion of international and $11 billion of U.S.. Now with the update, we've taken international up $500 million, so from $4 billion- $4.5 billion.

Chris Schott
Managing Director, JPMorgan

Mm-hmm.

Rob Michael
CFO, AbbVie

That's obviously offset in the U.S. given the recent label updates.

Chris Schott
Managing Director, JPMorgan

Okay, great. Maybe one last one on this topic. You know, I was thinking about new indications for both RINVOQ and SKYRIZI. Can you talk about IBD? It seems like you've had some really nice data for both drugs. I'm just trying to get a sense of how that data compared to your expectations and maybe, I think about the longer term, maybe beyond 2025, how big can those indications become?

Michael Severino
President and Vice Chairman, AbbVie

Well, as you point out, Chris, we've had some very strong data for both SKYRIZI and RINVOQ. To focus on RINVOQ right now, what I would say is that the data that we've read out, both in ulcerative colitis and in Crohn's disease, have exceeded our expectations going into phase III. That's true both from the efficacy and the safety perspective. From an efficacy perspective, we see very high levels of response. We see very deep response, very durable response, and response that shows up on very stringent measures of endoscopic healing. So we're having major endoscopic responses, good results on mucosal healing, and all of those are important attributes for a product that'll be coming forward in the future in IBD, because the bar is really being raised, and RINVOQ has exceeded that bar.

It has done so with a very good profile as well. Compared to our initial view at the time that we put out the long-term guidance for immunology in 2020, I would say the data have come in ahead of those expectations, and we think it can be a very meaningful product.

Jeffrey Stewart
EVP and COO, AbbVie

Chris, it's Jeff. To build on that point, you know, the IBD market is extremely attractive. I mean, at its peak level, IBD was about 40% of all the HUMIRA sales.

Chris Schott
Managing Director, JPMorgan

Mm-hmm.

Jeffrey Stewart
EVP and COO, AbbVie

I have to say historically, we were always very pleasantly surprised at how fast that market started to move. To build on Mike's point is this is coming very, very fast. One of the ways that we think about it commercially is that our existing sales forces, right now they're promoting HUMIRA. One sleeve promotes Crohn's, the other sleeve promotes UC for HUMIRA. We'll bring in both RINVOQ and SKYRIZI at the same time.

Chris Schott
Managing Director, JPMorgan

Mm-hmm.

Jeffrey Stewart
EVP and COO, AbbVie

With CD first for SKYRIZI and UC for RINVOQ right at the same time to the gastro community. Not only have basically the levels of efficacy, particularly on the endoscopic endpoints Mike highlighted, surpassed our expectations, we're really gearing up for a big push into the market very soon here in 2022. It's an exciting opportunity, and that's what's being reflected in the new guidance.

Chris Schott
Managing Director, JPMorgan

Great. Another topic. I know with both of these launches, you're able to get coverage fairly quickly post-approval. Should we think about the same in IBD, that this is gonna be, you know, once you get the approvals, you know, in pretty short order, you're gonna be able to kinda hit the ground running with full coverage? Is that a reasonable way to think about this?

Jeffrey Stewart
EVP and COO, AbbVie

Yeah. That's a very reasonable assumption in terms of the way that the payers are looking at the profile of our new agents and the new indications that are still in the pipeline. It's our anticipation that, you know, it's not immediate, but, you know, the way that we had the access ramp for RA and psoriasis is a very similar expectation that we have high confidence in as we see those IBD approvals.

Chris Schott
Managing Director, JPMorgan

Okay, great. My final one on this topic, just best guess or any expectation on atopic derm when we can think about a U.S. approval. Are we pretty close to goal line here or just, what's your latest expectation?

Michael Severino
President and Vice Chairman, AbbVie

I would say we're making very good progress and we would expect an approval decision soon.

Chris Schott
Managing Director, JPMorgan

Okay.

Jeffrey Stewart
EVP and COO, AbbVie

Chris, maybe before we move off for the RINVOQ and SKYRIZI topic, I think it's important. We wanted to highlight it in the presentation, but I don't think investors totally appreciate, and I certainly don't see that when I look at sell side consensus, that RINVOQ and SKYRIZI, when we think about the growth beyond 2025, and we think about the we, you know, we expect to have all the major indications of HUMIRA covered, plus atopic dermatitis, that we fully believe that RINVOQ and SKYRIZI at peak will be greater than HUMIRA was at peak. I don't think that's always fully appreciated. I wanna make sure to highlight that as well.

Chris Schott
Managing Director, JPMorgan

Yeah, that's a great point. Maybe just as we think about the HUMIRA side of things, I know you've talked for quite a while now about this 45% erosion target, ±10%. I guess we're now getting closer to the event. Just talk a little bit about your confidence in that number. I guess, are you getting additional visibility as you start to negotiate formulary position, et cetera, that allows you to, you know, either hone in that number a little bit more or, you know, just tell us a bit about your confidence of landing around that target.

Rob Michael
CFO, AbbVie

I think as we go through the negotiations this summer, we start getting into, you know, kind of later this year, we'll be in a position to further refine that estimate. I think the 45% is a good, you know, is good direction to provide as we think about the international markets, what we saw in Europe with competitive intensity having four biosimilars come in. We have seven and nine we're anticipating will come in next year. I think it's reasonable to assume a, you know, similar like first year, you know, step down, put a ±10% range because, you know, there's no payer landscape that's analogous to the U.S., so it's difficult to draw a direct analog there.

That's a good way to think about that 2023 erosion and that, you know, 45% ±10% for the U.S.. We have a number of areas obviously that are growing, and that will put us in a position to, although we'll have a decline in 2023, return to growth in 2024, moderate growth in 2024, then have high single digit growth in 2025, expand in a decade. We're in a unique position given the diversity of our business to be able to return to growth very rapidly.

Chris Schott
Managing Director, JPMorgan

Great. Some of the prior margin comments you've made, do those still hold in terms of, I don't know, as you think about the investment you seem to make in your business, can you manage those despite that 23% erosion you're expecting?

Rob Michael
CFO, AbbVie

Yeah, just a recap. I mean, we had guided 2021 operating margin about 50%, approximately 50%. I'd expect some level of expansion this year as you think about, you know, synergies ramping as well as, you know, the top line growing and the P&L leverage that we've historically been able to achieve. I would expect, you know, operating margins to expand again in 2022. We will see a decline in 2023 given the U.S. HUMIRA LOE. What I've been saying is think of it in the 46%-47% range as a trough level of operating margin, which still is top tier in our industry. Then as we return to growth very quickly, you'll start to see those operating margins expand once again.

Chris Schott
Managing Director, JPMorgan

Perfect. Just to jump around a little bit. I know cystic fibrosis, big question you guys have been getting pretty consistently for the last six or nine months. Just any update in terms of when we can think about that data. Anything you've seen yet or when can we expect an update on that front?

Michael Severino
President and Vice Chairman, AbbVie

I think we're making good progress against the timing that I described on our last call. We would expect to be in a position to top line the data and give people an idea of our decision to advance the program or not this quarter. We're making good progress against this quarter, but I don't have an update for you today.

Chris Schott
Managing Director, JPMorgan

Okay. Can you remind just the threshold that you have for moving forward on this? Is this something we need to see FEV numbers that are comparable to Trikafta to move forward? Just for me to get a sense of like what, how you evaluate, you know, what is the competitive agents, I guess, in the study?

Michael Severino
President and Vice Chairman, AbbVie

Well, there's certainly a number of features that go into making a competitive regimen here. We think efficacy is clearly very important. We do think there is room to meet or exceed the bar that is being set by Vertex. And our goal would be to be better from an efficacy perspective. Having said that, there are other ways to differentiate a product that is highly efficacious as well. There could be advantages, for example, on drug interactions or tolerability that could be important. We'll look at that entire package. We wanna have a regimen that is very competitive, that delivers efficacy to patients in the manner that they need to improve their long-term functioning and ultimately long-term survival.

We'll look at that complete package in terms of efficacy as well as safety tolerability, in addition.

Chris Schott
Managing Director, JPMorgan

Okay. Kinda stay tuned for a update, sounds like in the next few months here. Aesthetics. This is an area that seems to have clearly benefited from increased investment from the larger AbbVie organization. I guess one of the questions I get is when we look at the 2021 performance and kind of benchmarking maybe towards 2019, given some of the COVID disruptions. Did we see most of that benefit last year, and we should think about kind of 2022 starting to trend back down towards that high single-digit growth rate that you're targeting through the end of the decade? Or is this a multi-year period where we could be seeing elevated growth rates, again, given the support you're putting behind the franchise?

Rob Michael
CFO, AbbVie

Yeah. I mean, as we work through the year, but if you recall, our original guidance for aesthetics in 2021 was $4.5 billion. On the Q3 call, we were at $5.1 billion. We've seen just tremendous progress there. Initially, we did the market research early in the year, our view was about one third of that, you know, additional growth. We look at the, you know, U.S. toxins and fillers markets, I mean, growing, talking 30%-40%. We thought a third of it was maybe related to, you know, pandemic recovery. Now we've been seeing this, the sustained level of market growth, you know, through 2021. It starts to tell us that a lot of it is driven, frankly, by the level of investment we put behind this business.

It's, you know, we're talking low penetration rates. There's a lot of headroom for growth. While I wouldn't expect 30%-40% type of growth rates going forward, I think it's safe to assume it'll likely be something higher than it was before we put this level of investment behind the business. We've just seen the benefit of what has been DTC on both BOTOX and JUVÉDERM, expanding the sales force, not only in the U.S. but in China, in the mid-tier cities. We've talked about those mid-tier cities being the size of a Chicago, so they're sizable markets. Just tremendous growth that, you know, the amount of investment we put behind it. Plus, we have focus. We have a global aesthetics business with international affiliates completely focused on aesthetics.

Those therapeutics products are being covered by, think of it, the AbbVie legacy commercial infrastructure. We have full dedication internationally to aesthetics. We have an R&D organization that's fully dedicated to aesthetics, BD fully dedicated to aesthetics. It's why it gives us tremendous confidence in why we took the guidance up to high single-digit growth. We wanna be very clear that we expect by 2029 to have revenue greater than $9 billion. It's through a continuous investment and, you know, progress in R&D as well as some of the BD investments we made most recently with Cellulite and Soliton, which is a very attractive opportunity for us. It's all those things. I'd say I would expect that level of performance to continue, but not necessarily at the 30%-40% market growth rate.

I don't think that's totally reasonable.

Chris Schott
Managing Director, JPMorgan

Yeah. 30 or 40 would be a tough hurdle to hit, I'm guessing. With the QULIPTA launch, if I'm pronouncing that right, I'm trying to get kind of when I think about, you've had really good uptake with UBRELVY, and I'm trying to just compare and contrast what this next launch could look like. Is that a reasonable launch curve to think about with this one? Or are there differences, I guess, in this market versus what you saw with UBRELVY?

Jeffrey Stewart
EVP and COO, AbbVie

Yeah, it's a little different. I'd have to say, Chris, that we're very pleased. I mean, 10-11 weeks in, the QULIPTA launch is moving very nicely. I have to say that from a total demand, it's exceeded our expectation, which was quite high. The first key message, I think, is the market really likes QULIPTA, right? If you remember, in terms of the pivotal efficacy, it was on the very high end of the range in terms of episodic prevention. You have, you know, very significant decrease in migraine days. You have almost 30% of people that don't have any more episodic migraine in our pivotal trial. The feedback that we get from the headache specialists, from the neurologists is extremely positive.

It's not that far off when we add in basically the bridge or the free drug program to the UBRELVY ramp in total. It's certainly, again, doing quite well. I think important metrics that we can actually see in the IQVIA data here early, if you take the UBRELVY new starts and the QULIPTA new starts, we've basically achieved market leadership for sure across the franchise, and that doesn't include these free goods. Those free goods are important to really get the early experience, and ultimately, as we ramp our access in the H1 of 2022, that starts to convert to the paid approach that we need. We're super pleased with QULIPTA.

One of the things that's probably not fully appreciated by the investors, and it's similar to your question on aesthetics, we've been able to reorient those sales forces to fully focus on the oral migraine. There's no distractions. They don't have to worry about VRAYLAR like they used to or BYSTOLIC or even LINZESS. They are 100% focused on UBRELVY for the acute patient and QULIPTA for that episodic patient. Clearly, the market is rewarding us in terms of that strategic move. We're quite pleased so far.

Chris Schott
Managing Director, JPMorgan

Excellent. As the CGRPs ramp, at some point, do these cannibalize BOTOX, or are you looking at that as a really distinct market, given the more severe patients that tends to end up being used in?

Jeffrey Stewart
EVP and COO, AbbVie

Yeah, it's a great question, and we believe that the cannibalization is probably not there. It's going to be minor. Let me give you the perspective on that, right? You have a very significant base of customers that are injectors. They like to inject BOTOX. As Rob highlighted, we have the leading in-play share in that chronic migraine segment. Then you have another group of physicians, even headache specialists. They may not be injectors. They're the ones that are rapidly adopting the oral CGRP preventatives, and they also use the injectable. There's not too much of an overlap. It's a very, very nice synergistic play.

in addition, I think, and this is the science that Mike's team is driving, is there's increasing interest, and some of it is happening today in the market, of combination use with BOTOX and an oral or injectable CGRP to get to what the KOLs call complete migraine freedom. So we're not overly concerned with cannibalization or trade-offs there, just based on how the market's structured.

Chris Schott
Managing Director, JPMorgan

Yeah. Excellent. Mike, a question for you just on oncology. What are you most excited about as you think about the pipeline here? Obviously, the CD3, CD20s gets a lot of attention, but if you look at kind of the broader oncology portfolio and pipeline, what would you highlight to us to focus on going forward?

Michael Severino
President and Vice Chairman, AbbVie

Well, I think there are a number of areas to be excited about in the oncology pipeline, both in hematologic oncology and in solid tumor oncology. In hemonc, I would point to the breadth of the pipeline that we've built out between IMBRUVICA and VENCLEXTA. IMBRUVICA and VENCLEXTA are great assets. They're changing the way those diseases are treated, diseases like CLL and AML and others. We've really rounded out the portfolio with epacadstat, but also with our BCMA by CD3 bispecific, giving us a play in broader myeloma. VENCLEXTA has a play in t(11;14) biomarker-defined myeloma, and that's 20% of myeloma. That's a big market.

The broader myeloma market can be accessed via BCMA, and we have an agent that has tremendous efficacy and a very favorable benefit-risk, particularly with respect to AEs like the cytokine release syndrome that is a hallmark of these conditions. We have navitoclax in phase III in myelofibrosis, an opportunity to have disease modification where none existed before. We have a CD47 antibody also that combines well with a number of our assets. We've really built out a complete portfolio, and that's the first thing I would point to. The second thing that I would point to is we're making great progress now in solid tumors, and that area has not been as advanced for us as our liquid tumor franchise.

With the breakthrough therapy designation that we've recently received for Teliso-V, our c-Met directed ADC, we're making very good progress. We have 54% response rates in heavily pretreated patients with non-small cell lung cancer. We have a suite of offerings that exploit that biology in additional ways. We have other warheads and other technologies to go with c-Met that really make it a franchise. We're making strong progress in immuno-oncology, particularly on the tumor immunosuppressive environment with mechanisms like CD39 and GARP and PTPN2. There's a lot to be excited about in that franchise.

Chris Schott
Managing Director, JPMorgan

Great. Maybe in the last minute here, would just love to hear about your thoughts on capital deployment and maybe the opportunity to accelerate capital deployment. I think you reached some of your delevering targets later this year. How does that change the way, I guess, AbbVie thinks about, you know, the amount of capital you can put to work, I guess, as we look out to 2023 and beyond?

Rob Michael
CFO, AbbVie

Yeah, I think through 2023, you should expect us to continue with that $2 billion per year that we've allocated to BD. We're gonna continue to deleverage. We will get our net leverage to approximately 2x by the end of this year. That's, you know, that's sort of the target I'm thinking about over the long term. As long as I have a path back to net leverage of 2x, we can certainly get the flexibility to operate. We'll continue growing the dividend. You know, we've obviously grew it to 8.5%. We will grow it. I expect lower growth, but we will grow it through 2024, then return to strong growth in 2025 and beyond.

Buybacks, as we've been saying for the last few years, it's really just to offset the dilutive impact of equity compensation. Think of it in roughly $1 billion per year range. Now, we'll get through 2023, and then, you know, we'll certainly with the portfolio we've assembled and returning to growth so quickly and high growth in 2025 and beyond, we feel great with the assets we have and certainly with five therapeutic areas that can drive long-term growth. We'll have flexibility. We'll certainly, if we wanna continue paying down debt, for 2024 and beyond, we can do that, but we'll have flexibility in terms of capital allocation to do a lot more, given the diversity of our business.

Chris Schott
Managing Director, JPMorgan

Excellent. Well, I think we're just about out of time. I really appreciate the comments today and thanks for joining us.

Rob Michael
CFO, AbbVie

Thanks, Chris.

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