AbbVie Inc. (ABBV) Q3 2025 Earnings Report, Transcript and Summary

Good morning, and thank you for standing by. Welcome to the AbbVie Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Today's call is also being recorded. If you have any objections, you may disconnect at this time. I would now like to introduce Ms. Liz Shea, Senior Vice President of Investor Relations. Thank you. You may begin.

Good morning, and thanks for joining us. Also on the call with me today are Rob Michael, Chairman and Chief Executive Officer; Jeff Stewart, Executive Vice President, Chief Commercial Officer; Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer; and Scott Reents, Executive Vice President, Chief Financial Officer. Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in our forward-looking statements. Additional information about these risks and uncertainties is included in our SEC filings. AbbVie undertakes no obligation to update these forward-looking statements, except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions. So with that, I'll turn the call over to Rob.

Thank you, Liz. Good morning, everyone, and thank you for joining us. AbbVie's business continues to perform above our expectations. We delivered another excellent quarter, including strong financial results, pipeline advancement across all stages of development and strategic investments to drive sustainable long-term growth. Given our positive momentum, we are raising our 2025 outlook for the third time this year. Starting with our third quarter performance, we delivered adjusted earnings per share of $1.86, which is $0.10 above our guidance midpoint. Total net revenues were nearly $15.8 billion, reflecting high single-digit sales growth and beating our expectations by approximately $300 million. I'm especially pleased with the execution of our growth platform, including combined sales growth of more than 40% from Skyrizi and Rinvoq, our leading immunology medicines as well as double-digit revenue growth from neuroscience, our second largest and fastest-growing therapeutic area. With no significant LOE events in the near term, our growth platform provides a clear line of sight to growth into the next decade. This puts AbbVie in a strong position to fully invest for the 2030s and beyond. Since our inception in 2013, we have invested more than $84 billion to research, discover and develop new medicines and solutions for patients. We anticipate $9 billion of adjusted R&D expense in 2025, a substantial increase from the prior year. This supports numerous pipeline opportunities across our core areas: immunology, oncology, neuroscience and aesthetics as well as new sources of growth like obesity. More broadly, I'm very pleased with the breadth and depth of our robust pipeline with approximately 90 programs across all stages of development. We are making excellent progress and expect several important milestones over the next 2 years, including new product approvals for tavapadon and PVEK, expanded indications for Rinvoq, Epkinly, Qulipta and Ubrelvy and pivotal data for lutikizumab, Temab-A and etentamig. These pipeline programs have the potential to drive growth for AbbVie later this decade. We also continue to invest in external innovation, adding novel mechanisms and platform technologies to further augment our pipeline to drive growth in the 2030s and beyond. Our recent deal activity includes announcing the acquisition of Gilgamesh's bretisilocin, expanding our psychiatry pipeline with a next-generation psychedelic currently in Phase II development for MDD. And closing the acquisition of CapstanTherapeutics, further strengthening our immunology pipeline with an in vivo CAR-T platform. Our consistently strong performance as well as the progress we are making to build and advance a robust pipeline fully supports our capital allocation priorities. This includes investing at least $10 billion of capital in the U.S. over the next 10 years. Construction is already underway for a new API manufacturing site in North Chicago as well as expansion of biologics manufacturing and R&D capacity at our existing site in Worcester. We are also committed to delivering a healthy, sustainable dividend that grows every year. Today, we announced a 5.5% increase in our quarterly cash dividend, beginning with the dividend payable in February 2026. Since inception, we have grown our quarterly dividend by more than 330%. In summary, this is an exciting time for AbbVie. We are demonstrating outstanding execution across our portfolio, and our long-term outlook remains very strong. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?

Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of approximately $7.9 billion, up 11.2% on an operational basis. Skyrizi and Rinvoq continue to exceed our expectations, once again demonstrating robust growth across a broad set of indications. Skyrizi global sales were $4.7 billion, reflecting operational growth of 46%. Rinvoq global revenues were nearly $2.2 billion, up 34.1% on an operational basis. I'm especially pleased with our portfolio performance in gastroenterology, where these 2 medicines are on pace to nearly double their combined sales in IBD this year. Our uptake in Crohn's disease remains impressive with Skyrizi and Rinvoq together achieving in-play share leadership in a dozen countries. This includes capturing roughly 50% of newer switching Crohn's patients across all lines of therapy in the U.S. We see similar momentum in ulcerative colitis as well with Skyrizi and Rinvoq collectively holding in-play share leadership in more than 10 key markets and capturing nearly 1 out of every 3 newer switching UC patients across all mechanisms in the U.S. IBD continues to be an area of high unmet need with substantial headroom for biologic penetration as well as expanding lines of therapy. Given the compelling efficacy, safety and dosing profiles for both assets, Skyrizi with less frequent dosing favored by patients and clinicians, especially for the maintenance treatment relative to the most effective dose for other IL-23s. And Rinvoq, often preferred for difficult-to-treat IBD cases, having demonstrated the strongest response rates in UC studies as well as very strong efficacy in CD as well. Along with Rinvoq's recently expanded label in IBD, which is a great outcome for patients who will now have access to Rinvoq earlier in the treatment paradigm when anti-TNF treatment is clinically and advisable. So we remain very competitively positioned for continued strong growth across gastroenterology. Moving to the rest of our core immunology indications. Skyrizi continues to perform exceptionally well in psoriasis, gaining share across our key markets. This includes an impressive 50% in-play patient share for biologics in the U.S. Rinvoq is also delivering strong prescription growth in rheumatology. In RA, Rinvoq continues to achieve the leading in-play patient share across lines of therapy. We now have 3 head-to-head studies demonstrating Rinvoq's superiority to other biologics in RA, including recent positive data from our SELECT-SWITCH trial, which clearly supports the clinical benefits of switching to Rinvoq after a first TNF failure. Lastly, we are seeing a very nice ramp in GCA, where Rinvoq now has full formulary coverage. I'm very pleased with the progress and look forward to the commercialization of additional sizable indications like alopecia areata and vitiligo. Turning now to Humira, which delivered global sales of $993 million, down 55.7% on an operational basis, reflecting biosimilar competition. We continue to anticipate Humira access in the U.S. will decrease throughout the remainder of this year and into 2026 as more plans select exclusionary contracts for existing patients. This step-up in volume erosion is expected to be partially offset by a price benefit also associated with these contract changes, which is included in our fourth quarter outlook. Moving to oncology, which delivered total revenues of nearly $1.7 billion, relatively flat versus prior year. Momentum from Venclexta as well as newer products, Elahere, Epkinly and EMRELIS helped to offset the expected sales decline from Imbruvica, which continues to be impacted by competitive dynamics in CLL. Overall, I'm very pleased with the progress we are making to expand our commercial capabilities in both heme and solid tumors with our existing portfolio. These efforts will ultimately support our emerging oncology pipeline, which includes several promising programs to improve patient outcomes in many difficult-to-treat cancers. Turning now to aesthetics, which delivered global sales of approximately $1.2 billion, down 4.2% on an operational basis. Botox Cosmetic global revenues were $637 million and Juvederm global sales were $253 million, with growth rates for both products down on an operational basis. While our portfolio is performing well from a competitive perspective, we continue to face challenging market conditions in several key markets, which are impacting our results. With overall consumer sentiment remaining quite low, especially in the U.S. as concerns about the economy and inflation weigh on discretionary spending, we now see category growth tracking below our previous assumptions globally. However, this near-term macro pressure does not dampen our excitement for the long-term potential of our leading aesthetics portfolio. We are investing to support patient activation with robust promotion and product innovation. We recently launched new consumer campaigns for BOTOX as well as fillers to further stimulate category growth, which remains highly underpenetrated and where we stand to disproportionately benefit upon market recovery giving our leading product shares. Innovation from our pipeline, including novel toxins like TrenibotE, a fast-acting short-duration toxin as well as several next-generation fillers will also provide growth in the coming years. Moving now to neuroscience, which is demonstrating exceptional performance. Total revenues were more than $2.8 billion, up 19.6% on an operational basis. I'm very pleased with our leading migraine portfolio with Ubrelvy, Qulipta and Botox Therapeutic all delivering robust double-digit growth. Qulipta is now the #1 CGRP treatment for migraine prevention with a total prescription share of approximately 7.5%. Vraylar is also performing well in both bipolar and [ AMDD ] with total sales of $934 million, up 6.7%. Physicians continue to report positive feedback on Vraylar's strong benefit risk profile, including dosing flexibility, low sedation and the ability to address anhedonia and anxiety symptoms often associated with depression. Lastly, in Parkinson's disease, VYALEV's launch trajectory has been very impressive. Total sales were $138 million, up 40% on a sequential basis. The uptake across international markets continues to exceed our expectations with physicians and patient communities highlighting meaningful improvements in on time and off time from the 24-hour delivery and the control of symptoms throughout the morning, day and night. VYALEV is the only Parkinson's treatment that often replaces the need for add-on oral therapies to manage motor fluctuations, reducing the daily pill, pill burden for these patients. We anticipate expanded coverage of VYALEV in the U.S. soon, which we expect will provide further revenue inflection next year. I'm also excited about tavapadon, where we are pursuing approval for use as a monotherapy for early Parkinson's disease as well as an adjunct to optimize oral therapy for more advanced patients. This will be a very complementary offering for both VYALEV and DUOPA. Given the significant commercial opportunity with our emerging Parkinson's portfolio, we are now actively expanding our field sales team to support higher anticipated demand next year. Overall, again, we are demonstrating strong revenue growth and our commercial execution has been outstanding. And with that, I'll turn the call to Roopal for comments on our R&D highlights. Roopal?

Thank you, Jeff. Starting with immunology, we announced positive top line results from the second Phase III Rinvoq alopecia areata trial, reinforcing the potential for Rinvoq to significantly improve hair regrowth for patients suffering from severe forms of this condition. Data were consistent with the results from the first trial with Rinvoq demonstrating meaningful improvement in hair regrowth across both doses compared to placebo. We remain on track to begin submitting regulatory applications later this year. We also recently announced positive top line results from 2 Phase III Rinvoq vitiligo trials. In both studies, Rinvoq met the co-primary and key secondary endpoints at week 48, demonstrating improvements in both total body and facial vitiligo scoring compared to placebo. We are very pleased with these results, which illustrate Rinvoq's potential to provide significant skin repigmentation to patients suffering from nonsegmental vitiligo. The daily challenges of living with this condition can often lead to depression and anxiety. With no approved systemic treatments, there is very high unmet need for these patients. Once approved, Rinvoq could potentially be the first systemic therapy available for vitiligo. Regulatory submissions are planned for early next year. Positive top line results were also announced from the SELECT-SWITCH trial, which compared Rinvoq to Humira in RA patients who had an inadequate response or intolerance to their first TNF inhibitor. This is the first head-to-head study comparing anti-TNF cycling versus switching to Rinvoq. In the study, Rinvoq demonstrated superiority to Humira for efficacy measures with nearly twice as many patients achieving low disease activity and remission. For RA patients who did not respond well to their first TNF inhibitor, these results clearly show the benefit of switching to Rinvoq rather than cycling to another anti-TNF. In IBD, Rinvoq recently received a label update in Crohn's disease and ulcerative colitis, allowing its use prior to anti-TNFs in patients who have received at least one approved systemic therapy when TNF inhibitors are clinically inadvisable. The treatment paradigm has evolved in IBD with increasing utilization of newer, higher efficacy agents like Skyrizi. There are certain clinical scenarios when an anti-TNF may not be the most appropriate next treatment option for a patient. This label update provides physicians with the flexibility to use Rinvoq prior to anti-TNFs for certain patients after they have tried another approved systemic therapy. Moving to oncology. The regulatory application was submitted to the FDA for PVEK in blastic plasmacytoid dendritic cell neoplasm. This rare aggressive blood cancer primarily affects an older population who is at high risk for complications with traditional chemotherapy or precluded from stem cell transplantation. As a new treatment providing durable responses with a manageable safety profile, our novel ADC has the potential to become an important new therapeutic option for these patients. At the recent ESMO meeting, we presented 3 orals for Temab-A, highlighting this novel ADC's potential, both as a monotherapy and in combination across advanced difficult-to-treat solid tumors. In CRC patients who received 2 or more prior lines of therapy and regardless of c-MET expression levels, Temab-A in combination with bevacizumab demonstrated manageable safety and better responses and disease control compared to current standard of care. Treatment with Temab-A at 2.4 milligrams per kilogram plus bevacizumab achieved an objective response rate of 30% and a confirmed disease control rate of 97% compared to rates of 0% and 70%, respectively, for Lonsurf plus bevacizumab. Based on these results, we plan to begin a Phase III study for this combination in late-line all-comers CRC. In a proof-of-concept study in pancreatic cancer, monotherapy Temab-A demonstrated an objective response rate of 24% in the overall population and 40% in patients who received first-line gemcitabine plus, Abraxane. A Phase II study in pancreatic cancer is expected to begin next year. And in an exploratory study in MET amplified solid tumors after progression following standard of care, monotherapy with Temab-A resulted in an objective response rate of 47% and median duration of response of 12.5 months for the 2.4 milligram per kilogram dose. Higher responses were observed in patients with non-small cell lung cancer with a rate of 69% and gastroesophageal cancer with a rate of 71%. A Phase II study in MET amplified solid tumors is expected to begin later this year. We are making significant progress with Temab-A across a broad range of tumors, and there is an increasing body of evidence demonstrating durable efficacy and a manageable safety profile in these difficult-to-treat cancers. We look forward to providing additional updates on Temab-A programs as data mature. In neuroscience, the regulatory application for tavapadon in Parkinson's disease was recently submitted to the FDA. For many patients with Parkinson's, existing oral therapies aren't sufficient to manage symptoms. Our selective D1/D5 receptor partial agonist demonstrated robust efficacy as a monotherapy in early Parkinson's disease and as an adjunct to levodopa-carbidopa oral therapy in patients still experiencing motor fluctuations. Once approved, we believe tavapadon will be an important new treatment option. Results from a Phase II study evaluating BOTOX in upper limb essential tremor were recently presented at the MDS Congress. In the study, BOTOX met the primary and all secondary endpoints, demonstrating significant improvements in all assessment measures compared to placebo. With a global patient population of about 25 million, essential tremor is the most common movement disorder. This progressive neurological condition can substantially hinder patients' physical activities and diminish their quality of life. Current treatment options are limited in terms of both efficacy and tolerability, leaving considerable need for new therapies. Based on these results, we plan to advance a new toxin for upper limb essential tremor. TrenibotE is a novel toxin that has demonstrated different pharmacologic properties preclinically compared to BOTOX, such as less diffusion to neighboring muscles. Phase II studies for TrenibotE in essential tremor and ventral hernia repair will begin next year. To further expand our neuropsychiatry pipeline, we acquired bretisilocin from Gilgamesh. Bretisilocin is a novel (5-HT)2A receptor agonist and 5-HT releaser with a short duration of hallucination that has demonstrated robust efficacy in a Phase II proof-of-concept study in major depressive disorder. Rapid efficacy was achieved after the initial dose with response and remission maintained through day 74 without additional intervention. This novel psychedelic has the potential to provide significant benefit to patients by offering rapid, robust and durable antidepressant effects following a short in-clinic treatment session. Additional Phase II studies in depression are expected to begin next year. To summarize, we continue to make good progress across all stages and therapeutic areas of our pipeline and look forward to many important pipeline milestones in the remainder of this year and into 2026. With that, I'll turn the call over to Scott.

Thank you, Roopal. Starting with our third quarter results, we reported adjusted earnings per share of $1.86, which is $0.10 above our guidance midpoint. These results include a $1.50 unfavorable impact from acquired IPR&D expense, primarily reflecting upfront charges for the acquisition of Capstan Therapeutics and our license agreement with IGI. Total net revenues were nearly $15.8 billion, reflecting growth of 8.4% on an operational basis, excluding a modestly favorable impact from foreign exchange. Importantly, our ex-Humira growth platform delivered reported sales growth of more than 20%, once again exceeding our expectations. Adjusted gross margin was 83.9% of sales, adjusted R&D expense was 14.3% of sales and adjusted SG&A expense was 21.6% of sales. The adjusted operating margin ratio was 30.9% of sales, which includes a 17% unfavorable impact from acquired IPR&D expense. Net interest expense was $667 million. The adjusted tax rate was 24.5%, reflecting the lower deductibility of acquired IPR&D expense this quarter. Turning to our financial outlook. We are raising our full year adjusted earnings per share guidance to between $10.61 and $10.65. Please note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the third quarter. We now expect total net revenues of approximately [ $16.9 billion, ] an increase of $400 million. This updated forecast primarily reflects Skyrizi global sales of $17.3 billion, an increase of $200 million with continued share gains in psoriasis and IBD. Neuroscience global revenues of $10.7 billion, an increase of $200 million, reflecting continued strength across Vraylar, Botox Therapeutic, VYALEV and the total oral CGRP portfolio. Aesthetics total sales of $4.9 billion, a decrease of $200 million, reflecting greater-than-expected market softness globally, with the remaining $200 million increase reflecting the collective momentum from Rinvoq and several other products across our diverse portfolio. And we also continue to assume a relatively neutral impact from foreign exchange on full year sales growth. Moving to the P&L for full year 2025. We continue to expect adjusted gross margin of 84% of sales, adjusted R&D expense of $9 billion and adjusted SG&A expense of $13.5 billion. We now anticipate an adjusted operating margin ratio of approximately 41% of sales, in line with our previous expectations after including the roughly 6% unfavorable impact of acquired IPR&D expense incurred through the third quarter. And we now forecast our non-GAAP tax rate to be approximately 17.3%, also reflecting the impact of acquired IPR&D. Turning to the fourth quarter. We anticipate net revenues of more than $16.3 billion. This reflects an estimated 1% favorable impact from foreign exchange on sales growth. We expect adjusted earnings per share between $3.32 and $3.36. This guidance does not include acquired IPR&D expense that may be incurred in the quarter. Finally, AbbVie's robust business performance continues to support our capital allocation priorities. Our cash balance at the end of September was more than $5.6 billion, and we generated approximately $13 billion of free cash flow in the first 9 months of the year, which includes nearly $2.2 billion of Skyrizi royalty payments. This free cash flow fully supports strong and growing quarterly dividend, which we are increasing 5.5% to $1.73 per share, beginning with the dividend payable in February 2026. As well as capacity for continued business development, we have executed approximately 30 deals since the beginning of 2024, and we continue to assess external innovation across all of our key growth areas. We also remain on track to achieve a net leverage ratio of 2x by the end of 2026. In closing, AbbVie once again delivered outstanding results and our financial outlook remains very strong. With that, I'll turn the call back over to Liz.

Thanks, Scott. We will now open the call for questions. [Operator Instructions] Cedric, we'll take the first question, please.

Yes. And our first question comes from Terence Flynn with Morgan Stanley.

Congrats on the quarter. Two for me. I guess the first is just, Rob, would love your perspective on the potential implications for your business of the new PBM model that Cigna discussed on their earnings call yesterday, I believe. And then IRA price negotiations recently concluded. And just wondering if you're able to comment at all on how those went for Vraylar and Linzess?

Thanks, Terence. So this is Rob. I'll start with your first question. I'm going to have actually Jeff supplement as well. But I think one thing that's important to think about as it relates to whether it's PBM reform, questions we've got on DTC, ultimately, what drives AbbVie's performance is our differentiated medicines, along with our execution track record and strong culture. And that's why we deliver similar strong performance in markets outside the U.S. where PBMs and DTC do not play a role. So now given our ability to execute, we are very good at utilizing the tools that are available to us. If there are changes to the PBM model, we will certainly be able to adapt effectively. I mean I think for us, as we think about it, the key is to continue developing differentiated medicines as that is what delivers real value and can drive growth in any environment. And I'll let Jeff speak more specifically to how we see the PBM model playing out.

Yes. Thanks, Rob. And just to sort of reiterate this approach. I mean, if you think about some of these announcements over the years, whether it's rebate pass-through or there's existing models like this that work today. And we think there's a lot of merit to that, like the ability for patients to share and lowering their out-of-pocket cost at the counter is a good approach. There's been a lot of structural barriers to that, of course, over the years. Sometimes it's the clients don't really have the incentive to go in based on how they're using those rebates, maybe to lower premiums. We all know those stories. I think the key point is Rob's point that across my global footprint, we're used to dealing with any type of approach, whether it's a net price market, it's a rebate-driven market or a hybrid market that's net price and rebate like Germany or HTA markets. So we're very, very adaptable to sort of any sort of structure because we rely on the distinctiveness of our brands. And when we position those in the right way, which we always do, we perform exceptionally well from a market share and a competitive perspective. So we'll continue. We don't know a lot of the details, but we talk to Cigna all the time. Our account teams talk. We talk at the executive level. So we'll continue to study it, but we're very confident in terms of if there were to be changes in the PBM model, we would adapt very well.

And Terence, this is Rob again. On your question regarding IRA, the prices are obviously not yet public. But I would say that the administration's focus on achieving greater reductions in this year's round was very clear. That said, the outcomes for Vraylar and Linzess will not impact our long-term guidance.

Yes. Our next question comes from Chris Schott with JPMorgan.

Just would love a little bit more of a discussion on the IL-23 market. Obviously, Skyrizi doing really well here. But just with the TREMFYA subcu induction dosing kind of rolling out, what are you seeing in terms of competitive dynamics and positioning? And how do you see kind of the dynamics between those you and that -- and your nearest competitor kind of evolving over time? And then my second question is just any initial look on 2026 as you think about the various pushes and pulls in the business? And anything in particular you think the Street isn't properly accounting for as we think about the outlook for next year?

Yes. Chris, it's Jeff. I'll take your first question. So yes, we are very pleased with Skyrizi's growth overall and in the quarter. I mean, 46% year-over-year is quite strong. So -- and we see that momentum with share gains, it's market growth, and we retain a very, very strong in-play share position in IBD. It's really a leadership position -- what we do see is we know that TREMFYA is going to gain some market share and in-place share. But what's actually happening is the category or the class of IL-23 is expanding incredibly rapidly. And we view this as a positive. We said before, this is not a zero-sum game. We're very confident in our competitive position. I'll give you a little bit of some numbers, more -- some more recent numbers to see how dramatic this is. So just over a year ago, when the IL-23 were entering, the NBRx share for UC, this is ulcerative colitis, which is the smaller of the 2 was around 5%. That was the penetration rate. Now it's approaching in this latest quarter, close to 40%. So this is a dramatic change in the adoption of the IL-23s. Skyrizi continues to grow. TREMFYA will grow. There's -- yes, there are subtle differences, but we're super confident in where this product will go. So Skyrizi is performing very, very well and we'll continue to do so. And don't forget, it's just not a Skyrizi story. AbbVie has uniquely sort of a one-two punch in this market. We've got Skyrizi and Rinvoq. And as I mentioned in my prepared remarks, our position with Rinvoq just got significantly stronger for gastroenterologists and patients with that enhanced indication. So what that allows to do is that physicians, if they choose, if someone is not eligible or it's inadvisable clinically for a TNF, you can go right to Rinvoq. So it's a really, really powerful position and setup for AbbVie right now and over time. So that's basically what we're observing in the marketplace.

And Chris, it's Roopal. For subcutaneous for Skyrizi, we'll see data next year for our own induction. And then that plus IV still leads to every 8-week dosing, which continues to be a major advantage.

And Chris, this is Rob. Regarding your question on 2026. Look, our business continues to perform exceptionally well. We've raised our revenue forecast this year by nearly $2 billion since our initial guidance in February, and that's not just coming from Skyrizi and Rinvoq. We're seeing overperformance across the entire neuroscience portfolio and oncology is ahead of our original guidance as well. That momentum should allow us to deliver strong growth next year despite headwinds from continued Humira erosion and Imbruvica IRA pricing. Recall that Imbruvica was negotiated and that pricing will kick in next year. And Humira erosion will continue, albeit not at the same absolute level as we saw in 2025. When I think about just the growth platform, in particular, obviously, a lot of attention is placed on Skyrizi and Rinvoq appropriately. But in neuroscience, when you think about the performance of Vraylar, our migraine franchise, inclusive of Botox Therapeutic, which a little bit over 40% of that business is for chronic migraine. And then VYALEV, we're just seeing tremendous ramps. And we're also starting to now see, as Jeff mentioned, we expect in the inflection, particularly with the U.S. We've seen some nice progress there. But I would say that will be a very nice growth driver for us in 2026. And so we're very pleased with the performance. Obviously, clearly, the momentum is there. We've now beaten and raised it every quarter of '25. And of course, we'll provide specific guidance for '26 on the fourth quarter call.

Our next question comes from Vamil Divan with Guggenheim Securities.

So I have 2, if I could. So one just around -- thanks for the comment, 2025 and now 2026. My question is actually around the 2027 guidance you've given for Skyrizi and Rinvoq before you be clearly on track to exceed that. I'm curious your thoughts around updating the Street on sort of your longer-term outlook for Skyrizi and Rinvoq. And then the other question is on the aesthetic side. Can you just comment on the latest market share since you have for both BOTOX and Juvederm in the U.S?

So Vamil, this is Rob. I'll take your first question. So as you recall, we updated the 2027 guidance for Skyrizi and Rinvoq during the Q4 call earlier this year. And since then, we have raised the combined guidance for 2025 by over $1.7 billion. So it's reasonable to assume that we will exceed that long-term guidance. And I think that will be very clear when we provide 2026 guidance on the upcoming Q4 call. Now we have provided long-term guidance in the past really to help investors understand what the company will look like on the other side of the Humira LOE event. We said we would rapidly return to robust growth and deliver high single-digit compound revenue growth from '24 to '29. And we gave product specifics to support that high single-digit growth outlook. I mean sitting here today, we have clearly demonstrated the rapid return to growth. Our 2025 sales outlook exceeds our previous peak by almost $3 billion, and that's within 2 years of the LOE event. And the Street now reflects our high single-digit growth outlook for this decade. I'd say there appears to be good recognition of our momentum with Skyrizi and Rinvoq, though they do continue to perform above our own expectations. And there's recognition that our diversified growth platform can drive top-tier performance. That said, there are a few things that remain underappreciated. I think one is our strategy to continue innovating in immunology and drive growth beyond Skyrizi and Rinvoq, both in terms of combination approaches with Skyrizi or Rinvoq as a backbone and through new platforms such as oral peptides and B cell depletion approaches. We also have lutikizumab in our pipeline. We have a TL1A. We have a TREM1 antibody. So I think there's quite a bit of depth here in the immunology pipeline that can set us up to grow beyond Skyrizi and Rinvoq. And I don't think that's always appreciated. We also do not see enough investor focus on our neuroscience franchise. It's increased but it's still not at the level that I think it should be given it's our second largest therapeutic area and the fastest growing in our portfolio. We have very strong positions in psych and migraine and an emerging leadership position in Parkinson's with VYALEV and tavapadon. We also have an opportunity to transform care for essential tremor. The Aliada platform also gives us the potential to advance Alzheimer's treatment. And our Gilgamesh and Gedeon Richter deals give us more depth in mood disorders. So at the same time, we are starting to see more attention on our oncology pipeline, including Temab-A in several solid tumors, etentamig in multiple myeloma, 706 in small cell lung cancer as well as the recent BD transactions for trispecific antibodies from Simcere and IGI. And given our clear runway to growth into the next decade, we are in a very strong position to continue increasing our R&D investment and acquiring more external innovation that can help drive long-term growth. So to me, it's more important that investors appreciate the depth of our pipeline that can drive growth in the next decade versus updating financial guidance again for this decade.

And Vamil, it's Jeff. I'll just give you some of the sense you asked about the dynamics in the U.S. with aesthetics. So really, just to start with the market. If you look at the U.S. toxin market, it's really in a flattish position in the U.S. The filler market has been problematic. It's been down double digits. When you look at our share, what we can see is that year-over-year, we are lower than we were last year because of the [indiscernible] reimagined. But sequentially, we're growing. So we sit in the low 60s in terms of BOTOX share, and that's a clear leadership position by a large margin in the U.S. When you look at the HA filler, generally, that's in the mid-40s, call it, 45%, and that's largely been very stable. So that gives you some sense of the dynamics. The big thing is as the leader, we have to invest and we are investing in the market, as I mentioned in my remarks. We have a significant BOTOX consumer campaign that's in the market. We're starting to see some nice pickup there. So we're encouraged. We have an HA filler sentiment campaign to make sure that we're working with all of our clinics to make sure we can revitalize and get that market stabilized and more robust because you really do need HA fillers to really get the aesthetics outcome. So we believe we can rehabilitate that segment. And we also have opened 3 very significant training and sort of practice growth centers around the country to continue to lead that marketplace. So that gives you a sense of the metrics that you were asking for.

Our next question comes from Matt Phipps with William Blair.

Congrats on another great quarter. Now the Gilgamesh acquisition closed, I wonder if you could give us any details on how you might design future studies, especially around the use of a low-dose active control. Maybe how do you see this fitting into the overall MDD treatment paradigm given the in-clinic administration?

Yes. Thanks, Matt. It's Roopal. We're very excited about this approach. With other psychedelics, they tend to have a very long tail, especially around hallucination. And this one has a very short duration. So when it's in clinic, it will be a short duration. And a lot of clinicians are prepared to do this already. So we're not worried about having that being a barrier for uptake. There is so much depression and unmet need, we think that patients and caregivers would really like more options like this one. The other benefit that we saw is a longer duration after just 1 or 2 doses. And that maybe speaks to this potential concept of rewiring. So we're very excited about that. So the key for us is in depression, looking at different doses and looking at different duration paradigms, and we're going to do that in Phase II and ultimately move into Phase III. There is this regulatory need for a low-dose comparator, and that's because of the potential unblinding. And the Phase II study that we've -- that Gilgamesh has already posted was against a low-dose comparator, and you saw those very large deltas. So that's what we're excited about, and we think there's opportunities in different lines of depression and potentially other mood disorders that we're going to investigate to go beyond just major depression.

Our next question comes from David Amsellem with Piper Sandler.

So I wanted to drill down on your Parkinson's franchise. Can you talk to uptake of the [ VYALEV ] and specifically what you're seeing regarding competitive dynamics given the availability of an [indiscernible]? So that's number one. And then on tavapadon, which you've talked about increasingly, you've got adjunctive therapy and also monotherapy here, so pretty versatile. But also bearing in mind that with oral therapies, it's highly genericized. So how are you thinking about sales potential there and ultimately, where you see a role in practice for tavapadon?

Yes. Thanks for the question. I'll start off and then turn it over to Roopal. So as Rob and I mentioned, we're very, very pleased with VYALEV around the world with sales ramping very, very nicely. And it is levodopa-carbidopa. So it's the gold standard. It's just the ability to get that in the subcu version. Cause is incredible disease stability and recovery. So we do see a lot of distinction versus, let's say, the competitors, and we've dealt with the competitors around the world. It's relatively new in the U.S. So in terms of what we see on the market perspective, the in-play capture right now is roughly 80%, 85% in favor of VYALEV. And that's because of the 24-hour coverage, you have far less supplemental orals. The levels of control are great, particularly when you wake up and you're through the night. The other metric that we look at is, in some cases, we've launched VYALEV after subcu apomorphine has been available in the international countries. And essentially, the shares invert very, very rapidly. So we're quite confident in the both short- and long-term position for a product like VYALEV. It really is an exceptional medication. So I'll turn it over to Roopal to talk about the tavapadon development and then ultimately, he and I can talk about where the positioning might be.

Yes. Thanks, Jeff. It's Roopal. Let me start on the VYALEV side briefly, dovetailing on what Jeff just went through. So on the R&D side, we've received very favorable feedback thus far from caregivers and patients. And I would say the word transformative is the common theme. And the benefit of VYALEV is a full 24-hour opportunity for state of control. And that facilitates the ability to sleep and the ability to wake up on ready to go and face the day. The competitor that you mentioned is a 16-hour profile, so may not afford that same 24-hour control. Also, as Jeff had mentioned, VYALEV delivers a meaningful dose of levodopa-carbidopa. So what that means is patients -- many patients no longer require their oral therapy. So that means a monotherapy simplified approach is possible. The competitor is provided as an adjunct. So you won't be able to get off of your oral therapies. Also with VYALEV, when you look at the maintenance phase, dyskinesia rates are very low. And with the competitor you mentioned, they're roughly 15% up to 30%. The other benefit of VYALEV from a competitive standpoint is we see less than a 5% rate of sedation. And with apomorphine, it's around 20%. And also VYALEV, we have limited headaches, and this is in the teens with apomorphine. Also, another benefit of VYALEV is no warnings for orthostatic hypertension or falls that can't be said about the competitor. And also, we have very low rates in no need for treatment for nausea. And with apomorphine initiation, you need an antiemetic and often that need to be taken 3 times a day. So as Jeff stated, I think we're very well positioned from a competitive standpoint with VYALEV for all the reasons I just mentioned. And then I think it's very important that we mentioned tavapadon. I spoke about just it's being submitted. And this will be a very nice complement to VYALEV as a monotherapy and as an adjunct. It's a once-a-day profile that has a long half-life, and it's going to allow patients to optimize their regimen before the need to moving to advanced therapies. And where our clinicians are excited about differentiation from existing oral generics is the efficacy, which approaches levodopa-carbidopa and the safety profile, that could be a key differentiator, and that's what our experts are telling us about. Specifically impulse control disorders, just around 1%. We've seen others reach as high as 30% or 40%. Immediate -- people fall asleep with this one, sedation is less than 5%, dyskinesia around 2% and peripheral edema, which can be quite a nuisance with the generic molecules and very difficult to treat even if you use potent diuretics, we don't see that as a problem, 1% or less with tavapadon. So we think for efficacy, safety, tolerability reasons, it has a chance to differentiate and again, a very nice complement to VYALEV.

Our next question comes from Dave Risinger with Leerink Partners.

Yes. So I have 2 questions. The first is, could you please discuss the outlook for accelerating growth as Humira's absolute dollar declines diminish in coming years? And then second, could you, Roopal, just comment on the top few pipeline candidate readouts that we should focus on over the next 6 months? I'm assuming Amylin is one of them, but what are the biggest cards that are turning over in the next 6 months or so?

David, this is Scott. I mean I'll -- some thoughts on your question about accelerating growth. So you're right, Humira continues to erode and step down this year with our guidance, it's going to step down just over -- in the U.S., just over $4 billion. Certainly, that step down in absolute dollars will diminish and will diminish next year as well, of course, given the math. We will see, certainly, though, significant percentage erosion from this year to next year as well. That will continue to erode as the tail starts to form in '26. So when you look at the business, I mean, the business has a number of strong drivers. You've seen the growth of the business today. I think that one thing that we've spoken about several times is our long-term guidance for high single-digit growth through the decade. That will be from the growth that we have this year, we've talked about that accelerating as we hit that. And we still remain extremely confident in our ability to achieve that high single-digit growth through the decade on the top line. The bottom line will continue to expand. This year, our EPS is roughly in line, a little bit ahead of the earnings growth, but we're going to have operating margin expansion driven by leverage and efficiencies in the SG&A line. So you will see earnings growth expand a little bit faster than the revenue growth through the decade with that long-term guidance.

And Dave, it's Roopal. I'll talk about some of the readouts we're excited about moving into 2026. In immunology, our IBD platform will start reading out data next year. This is in combination with Skyrizi, looking at those combos versus monotherapy Skyrizi. Lutikizumab is one of those and the other is our own alpha4beta7-382. So we'll start seeing that data next year. Also in combination with lutikizumab plus [ Arava ] in rheumatoid arthritis, that will be something else to look for. And then maybe turning to oncology for a moment. For Temab-A, we've -- I went through a variety of different positive readouts. Also next year, expect to readout in head and neck cancer and even ovarian cancer, which many of these patients have high c-MET expression, along with etentamig in a variety of different combinations in multiple myeloma. And then our next-gen coming after Elahere, our biparatopic FR alpha antibody 151, we'll start seeing readouts there in platinum-resistant ovarian cancer. And then also next year, we're excited about our -- using our bispecific technology that we spoke about in immunology, along with our linker and warhead technology from oncology putting those together, we have a bispecific ADC that binds to PSMA and STEAP for prostate cancer. And that's another one, I would say, to look for next year. And then in neuroscience, we have our follow-on to VRAYLAR-932. We'll start seeing data in bipolar depression, probably moving into '27, looking for generalized anxiety disorder. And then we'll also be able to give an update on emraclidine we're currently conducting a multi-ascending dose trial to see if we can move the dose above 30 milligrams, and that has already initiated, and we'll be able to give an update on where the dose lands. And once it does, we can start moving into Phase II programs there in schizophrenia as an adjunct and potentially as a monotherapy along with psychosis associated with neurodegeneration. And then on the obesity front, the Phase I study will get data in the first half of next year from healthy volunteers looking at different starting doses and different titration schemes. However, these patients will have normal BMI, and we've already seen reasonable weight loss there at 6 weeks. So we'll also have 12-week data. The other thing, Dave, I'll mention is we're starting a Phase Ib program late this year, maybe into January when we get everything started. But that will also look at our 295 Amylin asset, but the difference will be -- different titrations and in patients that have obesity. And that data will also likely read out probably in Q4 of next year. So I would say a very robust number of events that we should keep our eyes on.

The next question comes from Steve Scala with TD Cowen.

Two questions. Rob, it sounds like IRA discounts are deeper this year than last year. You said it will not impact the long-term outlook, but will it impact the outlook in 2026, which you have yet to share externally, but will it impact the numbers that you otherwise would have shared externally? Secondly, why was Rinvoq's Phase III in HS updated to complete in 2028 from 2026 previously? Was it an issue with endpoint, enrollment or something else?

So Steve, this is Rob. I'll take your first question, then Roopal will take your second question. So as it relates to the Vraylar and Linzess negotiations, keep in mind, those prices will not take effect until 2027. Again, as I mentioned before, we have visibility to where it's landing. It's obviously not public yet, but we're not concerned about it impacting our long-term guidance, but there's no impact in '26 because those prices do not take effect in '26.

And Steve, it's Roopal. We still anticipate our double-blinded week 16 data at the end of next year in HS. We'll get other double-blinded cuts and then there's open-label extension. So sometimes that changes on duration, how long we follow patients could result in some updates to [ ct.gov. ]

Your first question comes from Simon Baker with Rothschild & Co Redburn.

Two, if I may, please. Firstly, on Rinvoq in nonsegmental vitiligo. In some markets, that's up to 2% of the population. So I just wonder if you could give us an idea on your thoughts of the size of that opportunity. And then secondly, on Elahere, I note in the press release that you are launching it in the U.K. at a list price equal to the U.S. Now on the basis that people in the U.S. don't generally pay the list price, should one assume the same situation in the U.K. And going forward in the U.K. and Europe, do you envisage moving more to a U.S. style gross to net type market from the more net market that we see at the moment?

Yes. So it's Jeff. I mentioned that as we look at the -- what we call the next wave of innovation around Rinvoq, and we've seen some of those readouts, which are really, really encouraging. GCA, which is the smallest of the next set of indications is performing really well and overall helping great momentum in rheumatology. So then when we look at basically the, let's say, the next big 4, okay? So you have alopecia areata, vitiligo, as you highlighted, HS, as Steve highlighted, and then lupus, we've looked and sized those that, that revenue potential is at least $2 billion at peak. So we continue to work through, given as we look at the data, we watch the market develop like how they will sort of adapt and change over time. I can say that the alopecia data was quite striking. I mean it's quite striking relative to the standard of care, Ig, other JAKs that are out there. So we're going through the sizing issue. We certainly see that there are different segments of vitiligo like the high body surface area is more amenable to, let's say, a JAK inhibitor like Rinvoq, which will be the first systemic. Is it active? Or is it stable? So net-net, I mean, you could say that all of these together would be greater than $2 billion, and we're going to continue to hone those forecasts as we go towards launches over the next year or so.

Thanks, Simon. Sorry, one more.

Just one more question on Elahere. You're right, the price in the U.K., the list price is similar to the U.S. One of the aspects that we are looking at is how basically because of the most favored nation and other global pricing dynamics, how that may or may not change our approaches around the world. Certainly, we would like to see reforms in many of the European countries, whether they are clawback systems or even the way that the HTAs work because we do think that these medicines should be more highly valued. So exactly how that will ultimately play out, certainly, some of the early discussions with the administration are around basically more stable and equitable pricing around G7 inclusive of Switzerland and Denmark. So all of that strategies are basically in place. Ultimately, how that will play out, we're going to continue to see. Certainly, in the U.K., as you know, you can have list prices, but ultimately, it's an HTA market, and we'll have to go through the NICE evaluation to see where that net price ultimately would land.

Our next question comes from Luisa Hector with Berenberg.

I'd like to ask in immunology, just if you could outline your next steps with your CAR-T and your oral peptide platforms. And then just a sort of longer-term question, but what level of market penetration do you think is ultimately achievable for the advanced therapies in the more mature indications, where could we actually get to? And would that require success from the combinations to raise efficacy ceiling or some of these new platform technologies?

Luisa, it's Roopal. I'll start with the insight to CAR-T from Capstan. What -- maybe some benefits and then we can talk about our plans. We have an opportunity to optimize that dose. It's also an off-the-shelf therapy. We also see rapid expression and also transient expression. So over time, that could have some safety advantages, especially if you can deplete the pathogenic B cells and then the naive B cell population repopulates and you don't have the CAR on board any longer, and that's the advantage of the mRNA therapy. In the early Phase I, we have observed B cell depletion. And the other benefit is no need for lymphodepletion. So taken together, this could be a very exciting opportunity for patients. So next steps is to continue dosing in the first-in-human studies. And then I would say, next year, once we have a handle on dosing, we'll start looking at patients starting on the rheumatology side of things like RA and lupus. And if it works similar to ex vivo CAR-T, we think patients can have very deep and durable remissions, which could be very, very important and certainly raises the bar and breaks through existing efficacy ceilings. So that's, I would say, on Capstan. On the oral side, the Nimble acquisition, these are macrocyclic molecules, the ones that we're focusing on, the attempt there is to make them as potent as possible and to extend the half-life. I think the current issue we see with certain oral platforms is that the half-life is very limited. We think a benefit would be to extend that half-life. So those are the 2 things that are going on. The lead candidates right now are an oral IL-23 and a TL1A. And when it comes to our IBD platform, with the combination, the higher the efficacy, the better, obviously. But many of these patients that we'll see will be second line and potentially even third line because lines of treatment are continuing to expand. You have many patients that have already received anti-TNFs in IBD, and you see medicines like Skyrizi also starting to penetrate into that front line. And if that's not working, then you have JAK inhibitors like Rinvoq. So we'd be studying a relatively refractory population. So if you can get 10-plus points better on the higher, the better, I think that would be a huge benefit because breaking through where current efficacy stands today has really been the challenge. And I would say some of the best assets we have are currently Rinvoq and Skyrizi.

And then the idea of the market structure that you highlighted in your second question, to Roopal's point, I mean, these immunology markets are quite amazing because you essentially have a bio penetration, which varies by major indication. And then you also have line of therapy expansion. So they are very, very buoyant because there's significant headroom and unmet need. To give you the bookend, when you look at biopenetration, I'm going to give you the U.S. biopenetration rates roughly and the European and Asia are lower generally based on the way those markets are developing. The highest biopenetration rates are in Crohn's disease, which is above 50%. So you still have quite a few patients in a very severe disease that have not been exposed to a biologic. And these are in the moderate to severe segmentation. On the very low end, you have a super dynamic market, which is atopic dermatitis, incredible high unmet need that just basically with the availability of drugs like Dupixent and Rinvoq, that may be in the high single-digit biopenetration for moderate to severe. So new technologies are going to help. Communications are going to help, a line of therapy is going to help. And that's why to Roopal's point, we're very excited about certainly the baseline adoption of these technologies, but transformative future technologies as well.

Yes. Our next question comes from Mohit Bansal with Wells Fargo.

I have a couple of them. So one is on oral IL-23, the competitors one. So Roopal, you mentioned some limitations there. Can you talk a little bit about how you think about this competition over time versus Skyrizi or Rinvoq? And then a portfolio question. So you do have Amylin in this space now with Gubra. How much do you think a portfolio of these assets, GLP or other assets is important to fight and win in this particular segment given that the competitors or incumbents have a portfolio of multiple assets out there?

Thanks, Mohit. It's Roopal. So I'll start. I think when we look at Skyrizi, first of all, the psoriasis data are very strong. Just to think about some of the numbers that we have, by week 16, if you're looking at clear or almost clear, you're approaching 90%. If you're looking at week 52, PASI 90, that's at 80%. And if you're at PASI 100, that's at 60%. So these are very, very high efficacy. And you also see over time, if you're an early PASI responder, the majority of these folks are going to maintain over the course of the year and beyond. And even if there is treatment withdrawal, and that's one thing I was getting at with why we like Nimble of potential half-life extension is that if you take oral, some people may miss some doses. And if you have a very short half-life, your treatment withdrawal data will sync very quickly. And if you miss many doses, you will lose effect. And with Skyrizi, and actually, this is even in our label, if you stop dosing for 1 year, you still have 60% of patients that are clear or almost clear. Now if you keep dosing, obviously, you'll get to that 80% to 90% range. So I think it's important just to set up where is Skyrizi today, and you have this opportunity to have quarterly dosing. So the patients have a chance to forget that they have psoriasis, and they don't have to worry about when they eat their meals or how long they need to be fasting. The other benefit is Skyrizi has what I would like to say is head-to-toe benefits, and these are all statistically significant readouts. What do I mean by that? That means palmoplantar, that means scalp and genital across the board. The other insight about psoriasis is about 30% or so will have psoriatic arthritis. So they'll have joint disease. And now with Skyrizi, we have 5 years of data where 88 -- approaching 90% of patients do not have x-ray progression. And I would say taking in totality, that gives you -- gives us a benefit to continue to be very competitive, whether you're talking about another injectable or even an oral. And the oral, as Jeff has stated, will have uptake like many of these assets because psoriasis, unlike IBD, is still quite underpenetrated, and it's a growing market. And maybe, Jeff, if you want to make a comment as well.

No, I think it's very clear, Roopal. We're very confident in our competitive position. And we've seen other orals enter the market. We have multiple head-to-head trials in terms of where those orals will compete and what the differences are. And so I think Roopal phrased it very, very nicely with his summary.

And then on the Amylin, yes, we think it would be of a benefit, and we do continue to look with partnered programs and external opportunities where you could potentially combine with the Amylin. And the focus there is tolerability and durability. We continue to see only about 30% of patients with obesity continuing their incretins after 1 year. So these beneficial gains are not going to result in long-term favorable outcomes if patients can't stay on these. So our focus is on the Amylin, but we continue to look for combination agents and also other orthogonal approaches if you have the opportunity to maintain bone and muscle and then we are also exploring the potentials [Audio Gap].

And our next question comes from Geoff Meacham with Citibank.

Okay. Rob, on the policy sides, I know we have some public agreements with the administration from your peers on Medicaid and onshoring and manufacturing. Just was curious if you expect to also have a formal agreement, if that's a priority. And then the second thing on aesthetics, it still seems that we're seeing more macro headwinds. And I know you've made some commercial and DTC investments as well as new launches. But what would you say are the leading indicators of a rebound? I'm just trying to assess what green shoots perhaps you may be seeing.

Geoff was asking a question. Obviously, we can't hear any. Sir, go ahead with your question.

Can you guys hear me at all?

Now, we can hear you. Hi, Geoff, sorry. We were unfortunately, disconnected.

Yes. No worries. Okay. So I just had 2 quick ones. Rob, on the policy side, I know we have some public agreements with the administration from your peers on Medicaid and onshore and manufacturing. I was curious if you expect to also have a formal agreement, if that's a priority for you guys. The second thing on aesthetics, it still seems that we're seeing more macro headwinds. And I know you've made some commercial and DTC investments and also have some new launches. But what would you say are the leading indicators of a rebound in aesthetics, I'm just trying to assess what green shoots perhaps you may be seeing.

Geoff, it's Rob. Thanks for the questions. So obviously, we continue to actively engage with the administration on ways to improve patient access and affordability and preserve U.S. leadership in medical innovation. We were having discussions before the July 31 letter and have had more discussions since. I'd say we are aligned on the need to address global freeloading and have been working closely with the USTR on ways to address that, which ultimately, I think a Section 301 investigation in unfair practices will be important as we partner with the administration to make progress in terms of pricing outside the U.S. We're open to expanding direct-to-patient models where it makes sense beyond what we already have in place with our Synthroid direct program. You've also seen us take actions to invest further in the U.S. by building a new API plant North Chicago and expanding biologics capacity in Worcester as part of our $10 billion capital commitment. So you see the company's commitment to innovation, driving future growth, and that's certainly something we're in discussions with the administration about. We also, as we mentioned previously, announced that Elahere has been priced in the U.K. at the same list price as the U.S. I'd say all these actions are directionally aligned with the administration's stated goals. And we'll continue to work with the administration on solutions that improve access and affordability while also supporting future innovation. And we'll certainly share more information as we have it.

And Geoff, some of the dynamics that we're looking at that we monitor, to your point, I mean, these market conditions have been more protracted than we anticipated. So it's challenging to predict. But here are a few of the things we look at. Obviously, we're looking at sort of overall consumer confidence. It's quite low. So that can be a leading indicator. We know that our middle-income consumers, particularly for BOTOX and toxins are also on the sidelines. So we monitor sort of their posture relative to sort of seeking particularly new treatment with the toxin, which is the leading indicator for the facial injectable business. And we also, as I highlighted in my remarks, we're monitoring every month sort of the HA filler sentiment. So we've seen that stabilize to some degree, which is good. It's not continuing to go down. But those are some metrics that we look at for early indicators to sort of anticipate sort of a market rebound. And again, we're going to invest through that. We think that, that's a good idea. Certainly, we also believe that TrenibotE, the ability to activate new consumers, which will come next year for the U.S. market is a significant catalyst to try to sort of lead this market back to health.

Our next question comes from Courtney Breen with Bernstein.

Perhaps one more on the policy side and then just a follow-up on Rinvoq. If you were to simply look at AbbVie's ratio of the business right now, about a 75% U.S. exposure versus 25% ex U.S., how different do you expect that to be in 5 years' time? How much of that might be down to the product mix? And how much of that might be down to kind of equalizing price or some of these new U.S. policies? And then the follow-up on Rinvoq was just about the expansion opportunity associated with the changes to the Rinvoq label. Can you just help us quantify that a little bit more clearly?

So this is Rob. I'll take your first question. So you're right, when you look at the business today, it's in the 75% U.S., 25% international. I think historically, before Humira, you saw it more like 2/3 to 1/3. We haven't publicly disclosed what that U.S. OUS mix will look like over the long term. Obviously, it's portfolio dependent. I'd say that is the larger driver of fluctuations that you see there versus assumptions around price. And so as we drive this business, given the innovative platform, there's opportunities to grow in the U.S., there's great opportunities to grow internationally. But the way to think about it is, if you think about historical levels where it was before Humira, that's not a bad way to think about where it could go over time. But we haven't publicly disclosed what that mix looks like in our long-term outlook.

And then in terms of the enhanced IBD label, we -- we haven't fully quantified it, but I would say it's clearly a net incremental positive. We weren't sure, frankly, that we would get this type of language as we worked with the U.S. KOLs and the FDA, but we did. So we're very happy with that. Clearly, what we see is that this benefit will build over time based on the dynamics that I mentioned and Roopal mentioned, which is you're seeing a very significant transformation over the structure of the IBD space, whereas a few years ago, it was a heavy TNF focus. And now you see this ascension of the IL-23s, you certainly still have ENTYVIO in there. And so this is a net positive, and we're going to continue to monitor how effective this is with that 1, 2 punch with that in-play share that we're continue to be very pleased with.

Thank Courtney. Operator, we have time for one final question.

Our last question comes from Asad Haider with Goldman Sachs.

Just maybe, Rob, for you on M&A. Just any updated thoughts following the recent acquisitions, Capstan and Gilgamesh. Just curious as to what your latest thinking is on business development. You've always referenced BD priorities that are geared towards the 2030s. Is that still the case? And amongst your core therapeutic areas, where would you prioritize adding? And then just also curious if you have any appetite for larger deals?

Thanks, Asad. This is Rob. I'll take that question. You're right, our BD focus continues to be on assets that can drive growth in the next decade and beyond. I mean we certainly have the financial wherewithal to pursue late-stage opportunities as well. But that's not really a need given that our current portfolio provides a clear line of sight to growth into the next decade. And that's why we have focused our efforts on novel mechanisms and platform technologies that can drive longer-term growth. And that includes B cell depletion approaches, which Roopal mentioned, and oral peptides capabilities in immunology, trispecifics and an in vivo CAR-T platform in oncology. You look at neuroscience, there's novel mechanisms for mood disorders and Alzheimer's that we've licensed in. And we have a very compelling siRNA platform that can generate opportunities across all 3 of those therapeutic areas. And we've also utilized BD to enter another growth area, obesity, which as Roopal mentioned, we will build upon. Again, given the strong outlook of the portfolio, we'll continue to focus on BD efforts that really drive long-term pipeline opportunities. And the areas of focus are our core areas: immunology, neuroscience, oncology, aesthetics, and we've now added obesity. And so you think about those are the areas. And if you think about the 30 deals we've executed, more than 30 deals we've executed over the last 18-plus months, there's been a nice mix between immunology, oncology, neuroscience, a few deals in aesthetics. So I think you should expect us to continue to add, I'd say, very robust depth to our pipeline to drive that long-term growth well into the next decade.

Thanks, Asad. And that concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us.

Thank you. That concludes today's conference. You may all disconnect at this time.